Patent Feb14

PATENT LAW, INDUSTRIAL DESIGN AND PLANT VARIETY PROTECTION, 2nd Sem, 2013-2014

c.2. Practical or Specific Utility • case: Brenner v. Manson

SUPREME COURT OF THE UNITED STATES

decided: March 21, 1966.

BRENNER, COMMISSIONER OF PATENTS v.

MANSON

CERTIORARI TO THE UNITED STATES COURT OF CUSTOMS AND PATENT APPEALS.

Warren, Fortas, Harlan, Brennan, Black, Stewart, Clark, White, Douglas

Author: Fortas

MR. JUSTICE FORTAS delivered the opinion of the Court.

This case presents two questions of importance to the administration of the patent laws: First, whether this Court has certiorari jurisdiction, upon petition of the Commissioner of Patents, to review decisions of the Court of Customs and Patent Appeals; and second, whether the practical utility of the compound produced by a chemical process is an essential element in establishing a prima facie case for the patentability of the process. The facts are as follows:

In December 1957, Howard Ringold and George Rosenkranz applied for a patent on an allegedly novel process for making certain known steroids.*fn1 They claimed priority as of December 17, 1956, the date on which they had filed for a Mexican patent. United States Patent No. 2,908,693 issued late in 1959.

In January 1960, respondent Manson, a chemist engaged in steroid research, filed an application to patent precisely the same process described by Ringold and Rosenkranz. He asserted that it was he who had discovered the process, and that he had done so before December 17, 1956. Accordingly, he requested that an "interference" be declared in order to try out the issue of priority between his claim and that of Ringold and Rosenkranz.*fn2

A Patent Office examiner denied Manson's application, and the denial was affirmed by the Board of Appeals within the Patent Office. The ground for rejection was the failure "to disclose any utility for" the chemical compound produced by the process. Letter of Examiner, dated May 24, 1960. This omission was not cured, in the opinion of the Patent Office, by Manson's reference to an article in the November 1956 issue of the Journal of Organic Chemistry, 21 J. Org. Chem. 1333-1335, which revealed that steroids of a class which included the compound in question were undergoing screening for possible tumor-inhibiting effects in mice, and that a homologue*fn3 adjacent to Manson's steroid had proven effective in that role. Said the Board of Appeals, "It is our view that the statutory requirement of usefulness of a product cannot be presumed merely because it happens to be closely related to another compound which is known to be useful."

The Court of Customs and Patent Appeals (hereinafter CCPA) reversed, Chief Judge Worley dissenting. 52 C. C. P. A. (Pat.) 739, 745, 333 F.2d 234, 237-238. The court held that Manson was entitled to a declaration of interference since "where a claimed process produces a known product it is not necessary to show utility for the product," so long as the product "is not alleged to be detrimental to the public interest." Certiorari was granted, 380 U.S. 971, to resolve this running dispute over what constitutes "utility" in chemical process claims,*fn4 as well as to answer the question concerning our certiorari jurisdiction.

I.

http://nh.findacase.com/research/wfrmDocViewer.aspx/xq/fac.19660321_0040770.sct.htm/qx#D*fn1





Section 1256 of Title 28 U. S. C. (1964 ed.), enacted in 1948, provides that "Cases in the Court of Customs and Patent Appeals may be reviewed by the Supreme Court by writ of certiorari." This unqualified language would seem to foreclose any challenge to our jurisdiction in the present case. Both the Government*fn5 and the respondent urge that we have certiorari jurisdiction over patent decisions of the CCPA, although the latter would confine our jurisdiction to those petitions filed by dissatisfied applicants and would deny the Commissioner of Patents the right to seek certiorari.*fn6 This concert of opinion does not settle the basic question because jurisdiction cannot be conferred by consent of the parties. The doubt that does exist stems from a decision of this Court, rendered in January 1927, in Postum Cereal Co. v. California Fig Nut Co., 272 U.S. 693, which has been widely interpreted as precluding certiorari jurisdiction over patent and trademark decisions of the CCPA.

Postum, however, was based upon a statutory scheme materially different from the present one. Postum involved a proceeding in the Patent Office to cancel a trademark. The Commissioner of Patents rejected the application. An appeal was taken to the then Court of Appeals for the District of Columbia, which in 1927 exercised the jurisdiction later transferred to the CCPA. Under the statutory arrangement in effect at the time, the judgment of the Court of Appeals was not definitive because it was not an order to the Patent Office determinative of the controversy. A subsequent bill in equity could be brought in the District Court and it was possible that a conflicting adjudication could thus be obtained. On this basis, the Court held that it could not review the decision of the Court of Appeals. It held that the conclusion of the Court of Appeals was an "administrative decision" rather than a "judicial judgment": "merely an instruction to the Commissioner of Patents by a court which is made part of the machinery of the Patent Office for administrative purposes." 272 U.S., at 698-699. Therefore, this Court concluded, the proceeding in the Court of Appeals -- essentially administrative in nature -- was neither case nor controversy within the meaning of Article III of the Constitution. Congress might confer such "administrative" tasks upon the courts of the District of Columbia, wrote Chief Justice Taft, but it could not empower this Court to participate therein.

Congress soon amended the statutory scheme. In March of 1927 it provided that an action in the District Court was to be alternative and not cumulative to appellate review, that it could not be maintained to overcome an adjudication in the Court of Appeals.*fn7 In 1929 Congress transferred appellate jurisdiction over the Commissioner's decisions from the Court of Appeals to what had been the Court of Customs Appeals and was now styled the Court of Customs and Patent Appeals.*fn8 Whereas the Court of Appeals had been empowered to take additional evidence and to substitute its judgment for that of the Commissioner, the CCPA was confined to the record made in the Patent Office.*fn9 Compare Federal Communications Comm'n v. Pottsville Broadcasting Co., 309 U.S. 134, 144-145. Despite these changes, however, Postum had acquired a life of its own. It continued to stand in the way of attempts to secure review here of CCPA decisions respecting the Commissioner of Patents. See, e. g., McBride v. Teeple, 311 U.S. 649, denying certiorari for "want of jurisdiction" on the authority of Postum.*fn10

This was the background against which Congress, in its 1948 codification of statutes pertaining to the judiciary, enacted § 1256, blandly providing in unqualified language for review on certiorari of "cases in the Court of Customs and Patent Appeals." Nothing in the legislative materials relating to the statute, except its language, is of assistance to us in the resolution of the present problem: Did the statutory changes which followed has no vitality in the present setting, and there remains no constitutional bar to our jurisdiction.

Having arrived at this conclusion, we have no difficulty in giving full force and effect to the generality of the language in § 1256. It would be entirely arbitrary for us to assume, despite the statutory language, that Congress in 1948 intended to enshrine Postum -- dependent as it was upon a statutory scheme fundamentally altered in 1927 and 1929 -- as a hidden exception to the sweep of § 1256. The contrary is more plausible: that by using broad and unqualified language, Congress intended our certiorari jurisdiction over CCPA cases to be as broad as the Constitution permits.

This conclusion is reinforced by reference to the anomalous consequences which would result were we to adopt a contrary view of § 1256. Determinations of the Patent Office may be challenged either by appeal to the CCPA or by suit instituted in the United States District Court for the District of Columbia. 35 U. S.








C. § 145, 28 U. S. C. § 1542 (1964 ed.). Where the latter route is elected, the decision obtained may be reviewed in the Court of Appeals for the District of Columbia Circuit, and ultimately in this Court upon writ of certiorari. Hoover Co. v. Coe, 325 U.S. 79. It would be strange indeed if corresponding certiorari jurisdiction did not exist where the alternative route was elected. Were that so, in the event of conflict between the CCPA and the courts of the District of Columbia, resolution by this Court would be achievable only if the litigants chose to proceed through the latter. Obviously, the orderly administration both of our certiorari jurisdiction and of the patent laws requires that ultimate review be available in this Court, regardless of the route chosen by the litigants.

We therefore conclude that § 1256 authorizes the grant of certiorari in the present case. We now turn to the merits.*fn12

II.

Our starting point is the proposition, neither disputed nor disputable, that one may patent only that which is "useful." In Graham v. John Deere Co., ante, p. 1, at 5-10, we have reviewed the history of the requisites of patentability, and it need not be repeated here. Suffice it to say that the concept of utility has maintained a central place in all of our patent legislation, beginning with the first patent law in 1790*fn13 and culminating in the present law's provision that

"Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title."*fn14

As is so often the case, however, a simple, everyday word can be pregnant with ambiguity when applied to the facts of life. That this is so is demonstrated by the present conflict between the Patent Office and the CCPA over how the test is to be applied to a chemical process which yields an already known product whose utility -- other than as a possible object of scientific inquiry -- has not yet been evidenced. It was not long ago that agency and court seemed of one mind on the question. In Application of Bremner, 37 C. C. P. A. (Pat.) 1032, 1034, 182 F.2d 216, 217, the court affirmed rejection by the Patent Office of both process and product claims. It noted that "no use for the products claimed to be developed by the processes had been shown in the specification." It held that "It was never intended that a patent be granted upon a product, or a process producing a product, unless such product be useful." Nor was this new doctrine in the court. See Thomas v. Michael, 35 C. C. P. A. (Pat.) 1036, 1038-1039, 166 F.2d 944, 946-947.

The Patent Office has remained steadfast in this view. The CCPA, however, has moved sharply away from Bremner. The trend began in Application of Nelson, 47 C. C. P. A. (Pat.) 1031, 280 F.2d 172. There, the court reversed the Patent Office's rejection of a claim on a process yielding chemical intermediates "useful to chemists doing research on steroids," despite the absence of evidence that any of the steroids thus ultimately produced were themselves "useful." The trend has accelerated,*fn15 culminating in the present case where the court held it sufficient that a process produces the result intended and is not "detrimental to the public interest." 52 C. C. P. A. (Pat.), at 745, 333 F.2d, at 238.

It is not remarkable that differences arise as to how the test of usefulness is to be applied to chemical processes. Even if we knew precisely what Congress meant in 1790 when it devised the "new and useful" phraseology and in subsequent re-enactments of the test, we should have difficulty in applying it in the context of contemporary chemistry where research is as comprehensive as man's grasp and where little or nothing is wholly beyond the pale of "utility" -- if that word is given its broadest reach.

Respondent does not -- at least in the first instance -- rest upon the extreme proposition, advanced by the court below, that a novel chemical process is patentable so long as it yields the intended product*fn16 and so long as the product is not itself "detrimental." Nor does he commit the outcome of his claim to the slightly more conventional proposition that any process is "useful" within the meaning of § 101 if it produces a compound whose potential usefulness is under investigation by serious scientific







researchers, although he urges this position, too, as an alternative basis for affirming the decision of the CCPA. Rather, he begins with the much more orthodox argument that his process has a specific utility which would entitle him to a declaration of interference even under the Patent Office's reading of § 101. The claim is that the supporting affidavits filed pursuant to Rule 204 (b), by reference to Ringold's 1956 article, reveal that an adjacent homologue of the steroid yielded by his process has been demonstrated to have tumor-inhibiting effects in mice, and that this discloses the requisite utility. We do not accept any of these theories as an adequate basis for overriding the determination of the Patent Office that the "utility" requirement has not been met.

Even on the assumption that the process would be patentable were respondent to show that the steroid produced had a tumor-inhibiting effect in mice,*fn17 we would not overrule the Patent Office finding that respondent has not made such a showing. The Patent Office held that, despite the reference to the adjacent homologue, respondent's papers did not disclose a sufficient likelihood that the steroid yielded by his process would have similar tumor-inhibiting characteristics. Indeed, respondent himself recognized that the presumption that adjacent homologues have the same utility*fn18 has been challenged in the steroid field because of "a greater known unpredictability of compounds in that field."*fn19 In these circumstances and in this technical area, we would not overturn the finding of the Primary Examiner, affirmed by the Board of Appeals and not challenged by the CCPA.

The second and third points of respondent's argument present issues of much importance. Is a chemical process "useful" within the meaning of § 101 either (1) because it works -- i. e., produces the intended product? or (2) because the compound yielded belongs to a class of compounds now the subject of serious scientific investigation? These contentions present the basic problem for our adjudication. Since we find no specific assistance in the legislative materials underlying § 101, we are remitted to an analysis of the problem in light of the general intent of Congress, the purposes of the patent system, and the implications of a decision one way or the other.

In support of his plea that we attenuate the requirement of "utility," respondent relies upon Justice Story's well-known statement that a "useful" invention is one "which may be applied to a beneficial use in society, in contradistinction to an invention injurious to the morals, health, or good order of society, or frivolous and insignificant"*fn20 -- and upon the assertion that to do so would encourage inventors of new processes to publicize the event for the benefit of the entire scientific community, thus widening the search for uses and increasing the fund of scientific knowledge. Justice Story's language sheds little light on our subject. Narrowly read, it does no more than compel us to decide whether the invention in question is "frivolous and insignificant" -- a query no easier of application than the one built into the statute. Read more broadly, so as to allow the patenting of any invention not positively harmful to society, it places such a special meaning on the word "useful" that we cannot accept it in the absence of evidence that Congress so intended. There are, after all, many things in this world which may not be considered "useful" but which, nevertheless, are totally without a capacity for harm.

It is true, of course, that one of the purposes of the patent system is to encourage dissemination of information concerning discoveries and inventions.*fn21 And it may be that inability to patent a process to some extent discourages disclosure and leads to greater secrecy than would otherwise be the case. The inventor of the process, or the corporate organization by which he is employed, has some incentive to keep the invention secret while uses for the product are searched out. However, in light of the highly developed art of drafting patent claims so that they disclose as little useful information as possible -- while broadening the scope of the claim as widely as possible -- the argument based upon the virtue of disclosure must be warily evaluated. Moreover, the pressure for secrecy is easily exaggerated, for if the inventor of a process cannot himself ascertain a "use" for that which his process yields, he has every incentive to make his invention known to those able to do so. Finally, how likely is disclosure of a patented process to spur research by others into the uses to which the product may be put? To the extent that the patentee has power to enforce his patent, there is little incentive for others to undertake a search for uses.

Whatever weight is attached to the value of encouraging disclosure and of inhibiting secrecy, we believe a more compelling consideration is that a process patent in the chemical field, which has not been







developed and pointed to the degree of specific utility, creates a monopoly of knowledge which should be granted only if clearly commanded by the statute. Until the process claim has been reduced to production of a product shown to be useful, the metes and bounds of that monopoly are not capable of precise delineation. It may engross a vast, unknown, and perhaps unknowable area. Such a patent may confer power to block off whole areas of scientific development,*fn22 without compensating benefit to the public. The basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility. Unless and until a process is refined and developed to this point -- where specific benefit exists in currently available form -- there is insufficient justification for permitting an applicant to engross what may prove to be a broad field.

These arguments for and against the patentability of a process which either has no known use or is useful only in the sense that it may be an object of scientific research would apply equally to the patenting of the product produced by the process. Respondent appears to concede that with respect to a product, as opposed to a process, Congress has struck the balance on the side of nonpatentability unless "utility" is shown. Indeed, the decisions of the CCPA are in accord with the view that a product may not be patented absent a showing of utility greater than any adduced in the present case.*fn23 We find absolutely no warrant for the proposition that although Congress intended that no patent be granted on a chemical compound whose sole "utility" consists of its potential role as an object of use-testing, a different set of rules was meant to apply to the process which yielded the unpatentable product.*fn24 That proposition seems to us little more than an attempt to evade the impact of the rules which concededly govern patentability of the product itself.

This is not to say that we mean to disparage the importance of contributions to the fund of scientific information short of the invention of something "useful," or that we are blind to the prospect that what now seems without "use" may tomorrow command the grateful attention of the public. But a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion. "[A] patent system must be related to the world of commerce rather than to the realm of philosophy. . . ."*fn25

The judgment of the CCPA is

Reversed.

MR. JUSTICE DOUGLAS, while acquiescing in Part I of the Court's opinion, dissents on the merits of the controversy for substantially the reasons stated by MR. JUSTICE HARLAN.

Disposition

52 C. C. P. A. (Pat.) 739, 333 F.2d 234, reversed.

MR. JUSTICE HARLAN, concurring in part and dissenting in part.

While I join the Court's opinion on the issue of certiorari jurisdiction, I cannot agree with its resolution of the important question of patentability.

Respondent has contended that a workable chemical process, which is both new and sufficiently nonobvious to satisfy the patent statute, is by its existence alone a contribution to chemistry and "useful" as the statute employs that term.*fn1 Certainly this reading of "useful" in the statute is within the scope of the constitutional grant, which states only that "to promote the Progress of Science and useful Arts," the exclusive right to "Writings and Discoveries" may be secured for limited times to those who produce them. Art. I, § 8. Yet the patent statute is somewhat differently worded and is on its face open both to respondent's construction and to the contrary reading given it by the Court. In the absence of legislative history on this issue, we are thrown back on policy and practice. Because I believe that the Court's policy arguments are not convincing and that past practice favors the respondent, I would reject







the narrow definition of "useful" and uphold the judgment of the Court of Customs and Patent Appeals (hereafter CCPA).

The Court's opinion sets out about half a dozen reasons in support of its interpretation. Several of these arguments seem to me to have almost no force. For instance, it is suggested that "until the process claim has been reduced to production of a product shown to be useful, the metes and bounds of that monopoly are not capable of precise delineation" (p. 534, ante) and "it may engross a vast, unknown, and perhaps unknowable area" (p. 534, ante). I fail to see the relevance of these assertions; process claims are not disallowed because the products they produce may be of "vast" importance nor, in any event, does advance knowledge of a specific product use provide much safeguard on this score or fix "metes and bounds" precisely since a hundred more uses may be found after a patent is granted and greatly enhance its value.

The further argument that an established product use is part of "the basic quid pro quo " (p. 534, ante) for the patent or is the requisite "successful conclusion" (p. 536, ante) of the inventor's search appears to beg the very question whether the process is "useful" simply because it facilitates further research into possible product uses. The same infirmity seems to inhere in the Court's argument that chemical products lacking immediate utility cannot be distinguished for present purposes from the processes which create them, that respondent appears to concede and the CCPA holds that the products are nonpatentable, and that therefore the processes are nonpatentable. Assuming that the two classes cannot be distinguished, a point not adequately considered in the briefs, and assuming further that the CCPA has firmly held such products nonpatentable,*fn2 this permits us to conclude only that the CCPA is wrong either as to the products or as to the processes and affords no basis for deciding whether both or neither should be patentable absent a specific product use.

More to the point, I think, are the Court's remaining, prudential arguments against patentability: namely, that disclosure induced by allowing a patent is partly undercut by patent-application drafting techniques, that disclosure may occur without granting a patent, and that a patent will discourage others from inventing uses for the product. How far opaque drafting may lessen the public benefits resulting from the issuance of a patent is not shown by any evidence in this case but, more important, the argument operates against all patents and gives no reason for singling out the class involved here. The thought that these inventions may be more likely than most to be disclosed even if patents are not allowed may have more force; but while empirical study of the industry might reveal that chemical researchers would behave in this fashion, the abstractly logical choice for them seems to me to maintain secrecy until a product use can be discovered. As to discouraging the search by others for product uses, there is no doubt this risk exists but the price paid for any patent is that research on other uses or improvements may be hampered because the original patentee will reap much of the reward. From the standpoint of the public interest the Constitution seems to have resolved that choice in favor of patentability.

What I find most troubling about the result reached by the Court is the impact it may have on chemical research. Chemistry is a highly interrelated field and a tangible benefit for society may be the outcome of a number of different discoveries, one discovery building upon the next. To encourage one chemist or research facility to invent and disseminate new processes and products may be vital to progress, although the product or process be without "utility" as the Court defines the term, because that discovery permits someone else to take a further but perhaps less difficult step leading to a commercially useful item. In my view, our awareness in this age of the importance of achieving and publicizing basic research should lead this Court to resolve uncertainties in its favor and uphold the respondent's position in this case.

This position is strengthened, I think, by what appears to have been the practice of the Patent Office during most of this century. While available proof is not conclusive, the commentators seem to be in agreement that until Application of Bremner, 37 C. C. P. A. (Pat.) 1032, 182 F.2d 216, in 1950, chemical patent applications were commonly granted although no resulting end use was stated or the statement was in extremely broad terms.*fn3Taking this to be true, Bremner represented a deviation from established practice which the CCPA has now sought to remedy in part only to find that the Patent Office




does not want to return to the beaten track. If usefulness was typically regarded as inherent during a long and prolific period of chemical research and development in this country, surely this is added reason why the Court's result should not be adopted until Congress expressly mandates it, presumably on the basis of empirical data which this Court does not possess.

Fully recognizing that there is ample room for disagreement on this problem when, as here, it is reviewed in the abstract, I believe the decision below should be affirmed.

• case: Fujikawa v. Wattanasin 93 F.3d 1559 (1996)

Yoshihiro FUJIKAWA, Mikio Suzuki, Hiroshi Iwasaki, Mitsuaki Sakashita and Masaki Kitahara, Appellants,

v.

Sompong WATTANASIN, Appellee. (Two Cases).

United States Court of Appeals, Federal Circuit. August 28, 1996. Steven B. Kelber, Oblon, Spivak, McClelland, Maier & Neustadt, P.C., Arlington, Virginia, argued, for appellants. Diane E. Furman, Sandoz Corporation, East Hanover, New Jersey, argued, for appellee. Before MAYER, CLEVENGER, and RADER, Circuit Judges. CLEVENGER, Circuit Judge. Yoshihiro Fujikawa et al. (Fujikawa) appeal from two decisions of the Board of Patent Appeals and Interferences of the United States Patent & Trademark Office (Board) granting priority of invention in two related interferences to Sompong Wattanasin, and denying Fujikawa's motion to add an additional sub-genus count to the interferences. We affirm. I

These interferences pertain to a compound and method for inhibiting cholesterol biosynthesis in humans and other animals. The compound count recites a genus of novel mevalonolactones. The method count recites a method of inhibiting the biosynthesis of cholesterol by administering to a "patient in need of said treatment" an appropriate dosage of a compound falling within the scope of the compound count.

The real parties in interest are Sandoz Pharmaceuticals Corporation (Sandoz), assignee of Wattanasin, and Nissan Chemical Industries, Ltd. (Nissan), assignee of Fujikawa.

The inventive activity of Fujikawa, the senior party, occurred overseas. Fujikawa can thus rely only on his effective filing date, August 20, 1987, to establish priority. 35 U.S.C. § 102(g) (1994). Whether Wattanasin is entitled to priority as against Fujikawa therefore turns on two discrete questions. First, whether Wattanasin has shown conception coupled with diligence from just prior to Fujikawa's effective filing date until reduction to practice. Id. Second, whether Wattanasin suppressed or concealed the invention between reduction to practice and filing. Id. With respect to the first question, Fujikawa does not directly challenge the Board's holdings on Wattanasin's conception or diligence, but rather contends that the Board incorrectly fixed the date of Wattanasin's reduction to practice. As for the second question, Fujikawa contends that the Board erred in concluding that Wattanasin had not suppressed or concealed the invention. Fujikawa seeks reversal, and thus to establish priority in its favor, on either ground.


II

The Board divided Wattanasin's inventive activity into two phases. The first phase commenced in 1979 when Sandoz began searching for drugs which would inhibit the biosynthesis of cholesterol. Inventor Wattanasin was assigned to this project in 1982, and during 1984-1985 he synthesized three compounds falling within the scope of the compound count. When tested in vitro, each of these compounds exhibited some cholesterol-inhibiting activity, although not all the chemicals were equally effective. Still, according to one Sandoz researcher, Dr. Damon, these test results indicated that, to a high probability, the three compounds "would be active when administered in vivo to a patient to inhibit cholesterol biosynthesis, i.e. for the treatment of hypercholesteremia or atherosclerosis." Notwithstanding these seemingly positive results, Sandoz shelved Wattanasin's project for almost two years, apparently because the level of in vitro activity in two of the three compounds was disappointingly low.

By January 1987, however, interest in Wattanasin's invention had revived, and the second phase of activity began. Over the next several months, four more compounds falling within the scope of the compound count were synthesized. In October, these compounds were tested for in vitro activity, and each of the four compounds yielded positive results. Again, however, there were significant differences in the level of in vitro activity of the four compounds. Two of the compounds in particular, numbered 64-935 and 64-936, exhibited in vitro activity significantly higher than that of the other two compounds, numbered 64-933 and 64-934.

Soon after, in December 1987, the three most active compounds in vitro were subjected to additional in vivo testing. For Sandoz, one primary purpose of these tests was to determine the in vivo potency of the three compounds relative to that of Compactin, a prior art compound of known cholesterol-inhibiting potency. From the results of the in vivo tests, reproduced in the margin,1 Sandoz calculated an ED502 for each of the compounds and compared it to the ED50 of Compactin. Only one of the compounds, compound 64-935, manifested a better ED50 than Compactin: an ED50 of 0.49 as compared to Compactin's ED50 of 3.5. All of the tests performed by Sandoz were conducted in accordance with established protocols.

During this period, Sandoz also began to consider whether, and when, a patent application should be filed for Wattanasin's invention. Several times during the second phase of activity, the Sandoz patent committee considered the question of Wattanasin's invention but decided that it was too early in the invention's development to file a patent application. Each time, however, the patent committee merely deferred decision on the matter and specified that it would be taken up again at subsequent meetings. Finally, in January 1988, with the in vivo testing completed, the Committee assigned Wattanasin's invention an "A" rating which meant that the invention was ripe for filing and that a patent application should be prepared. The case was assigned to a Ms. Geisser, a young patent attorney in the Sandoz patent department with little experience in the pharmaceutical field.

Over the next several months the Sandoz patent department collected additional data from the inventor which was needed to prepare the patent application. This data gathering took until approximately the end of May 1988. At that point, work on the case seems to have ceased for several months until Ms. Geisser began preparing a draft sometime in the latter half of 1988. The parties dispute when this preparation began. Fujikawa contends that it occurred as late as October, and that Ms. Geisser was spurred to begin preparing the draft application by the discovery that a patent to the same subject matter had been issued to a third party, Picard. Fujikawa, however, has no evidence to support that contention. In contrast, Sandoz contends that Ms. Geisser began the draft as early as August, and that she was already working on the draft when she first heard of Picard's patent. The evidence of record, and in particular the testimony of Ms. Geisser, supports that version of events. In any event, the draft was completed in November and, after several turn-arounds with the inventor, ultimately filed in March of 1989.


Both Wattanasin and Fujikawa requested an interference with Picard. The requests were granted and a three-party interference between Picard, Fujikawa, and Wattanasin was set up. Early in the proceedings, however, Picard filed a request for an adverse judgment presumably because he could not antedate Fujikawa's priority date. What remained was a two-party interference between Fujikawa and Wattanasin. Ultimately, for reasons not significant to this appeal, the interference was divided into two interferences: one relating to the method count and one relating to the compound count. The Board decided each of these interferences adverse to Fujikawa.

With respect to the compound count, the Board made two alternative findings regarding reduction to practice. First, it found that the in vitro results in October 1987 showed sufficient practical utility for the compound so as to constitute a reduction to practice as of the date of those tests.3 In the alternative, the Board held, the in vivo tests which showed significant activity in the 64-935 compound at doses of 1.0 and 0.1 mg were sufficient to show practical utility. Consequently, Wattanasin had reduced the compound to practice, at the latest, as of December 1987. Since Fujikawa did not challenge Wattanasin's diligence for the period between Fujikawa's effective filing date of August 20, 1987 and Wattanasin's reduction to practice in either October or December 1987, the Board held that Wattanasin was de facto the first inventor of the compound count. Finally, the Board found that the seventeen month period (counting from the in vitro testing) or fifteen month period (counting from the in vivo testing) between Wattanasin's reduction to practice and filing was not sufficient to raise an inference of suppression or concealment given the complexity of the invention, and therefore awarded priority of the compound count to Wattanasin. In reaching this conclusion, the Board rejected Fujikawa's argument that Wattanasin was spurred to file by Picard because it held that spurring by Picard, a third party, had no legal effect in a priority dispute between Fujikawa and Wattanasin.

With respect to the method count, the Board determined that Wattanasin reduced to practice in December 1987 on the date that in vivo testing of the 64-935 compound was concluded. In reaching that conclusion, the Board first noted that a reduction to practice must include every limitation of the count. Consequently, Wattanasin's early in vitro testing could not constitute a reduction to practice of the method count, since that count recites administering the compound to a "patient." The in vivo testing, however, met the limitations of the count since the word "patient" was sufficiently broad to include the laboratory rats to whom the compounds were administered. The in vivo testing also proved that 64-935 had practical utility because the compound displayed significant cholesterol inhibiting activity at doses of 1.0 and 0.1 mg. Given this date of reduction to practice, the Board again held that Wattanasin was the de facto first inventor of the count and that the delay in filing of fifteen months was not sufficient to trigger an inference of suppression or concealment. The Board therefore awarded priority of the method count to Wattanasin.

Before this court, Fujikawa seeks review of these adverse priority determinations. In addition, during the motions period of the interference, Fujikawa moved to have an additional sub-genus count added to the interference. The Board denied that motion on the ground that the Wattanasin disclosure did not contain a sufficient written description to support the proposed count. Fujikawa appeals that decision, as well. We have jurisdiction to hear this appeal under 28 U.S.C. § 1295(a)(4)(A) (1994).

III

We first address Fujikawa's argument that Wattanasin's in vitro and in vivo tests failed to establish a practical utility for either the compound or method count. The Board held that the in vitro tests established a practical utility for the compound and that the in vivo tests established a practical utility for both the compound and method counts. For the reasons set out below, we affirm these findings of the Board.


For over 200 years, the concept of utility has occupied a central role in our patent system. See Brenner v. Manson, 383 U.S. 519, 529, 86 S.Ct. 1033, 1039, 16 L.Ed.2d 69, 148 USPQ 689, 693 (1966). Indeed, "[t]he basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility." Id. at 534, 86 S.Ct.at 1042, 148 USPQ at 695. Consequently, it is well established that a patent may not be granted to an invention unless substantial or practical utility for the invention has been discovered and disclosed. See Cross v. Iizuka, 753 F.2d 1040, 1044, 224 USPQ 739, 742 (Fed.Cir. 1985). Similarly, actual reduction to practice, which constitutes in law the final phase of invention, cannot be established absent a showing of practical utility. See Blicke v. Treves, 44 C.C.P.A. 753, 241 F.2d 718, 720-21, 112 USPQ 472, 474-75 (1957).

In the pharmaceutical arts, our court has long held that practical utility may be shown by adequate evidence of any pharmacological activity. See, e.g., Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980); In re Krimmel, 48 C.C.P.A. 1116, 292 F.2d 948, 952-53, 130 USPQ 215, 219 (1961). For example, in Campbell v. Wettstein, 476 F.2d 642, 646-47, 177 USPQ 376, 379 (CCPA 1973) we stated that "[m]oreover, the interference counts contain no limitation relating to intended use or to discovered properties of the claimed compounds. Accordingly, under well-established precedent, evidence establishing substantial utility for any purpose is sufficient to show reduction to practice." The rule in Campbell was applied in Rey-Bellet v. Engelhardt, 493 F.2d 1380, 1383, 181 USPQ 453, 454 (CCPA 1974) ("Since the count contains no limitation related to any utility, evidence which would establish a substantial utility for any purpose is sufficient to show its reduction to practice.").4 Such activity constitutes a practical utility because "[i]t is inherently faster and easier to combat illnesses and alleviate symptoms when the medical profession is armed with an arsenal of chemicals having known pharmacological activities. Since it is crucial to provide researchers with an incentive to disclose pharmacological activities in as many compounds as possible, we conclude that adequate proof of any such activity constitutes a showing of practical utility." Nelson, 626 F.2d at 856, 206 USPQ at 883; see also Krimmel, 292 F.2d at 952-53, 130 USPQ at 219.

It may be difficult to predict, however, whether a novel compound will exhibit pharmacological activity, even when the behavior of analogous compounds is known to those skilled in the art. Consequently, testing is often required to establish practical utility. See, e.g., Blicke, 241 F.2d at 720, 112 USPQ at 475. But the test results need not absolutely prove that the compound is pharmacologically active. All that is required is that the tests be "reasonably indicative of the desired [pharmacological] response." Nelson, 626 F.2d at 856, 206 USPQ at 884. (emphasis added). In other words, there must be a sufficient correlation between the tests and an asserted pharmacological activity so as to convince those skilled in the art, to a reasonable probability, that the novel compound will exhibit the asserted pharmacological behavior. See Cross, 753 F.2d at 1050, 224 USPQ at 747.

The ultimate determination of reduction to practice is a question of law which we review de novo. See Holmwood v. Sugavanam, 948 F.2d 1236, 1238, 20 USPQ2d 1712, 1714 (Fed.Cir.1991). In contrast, we review the Board's factual findings supporting its legal conclusions about reduction to practice for clear error. Id. Whether a practical utility has been established for a novel compound is a question of fact. See Cross, 753 F.2d at 1044 n. 7, 224 USPQ at 742 n. 7. We therefore review the Board's findings with respect to practical utility for clear error.

A

This court has, on many occasions, considered the type and quantity of testing necessary to establish a practical utility for a novel compound. Although each case of practical utility must be considered on its


own facts, see, e.g., Blicke, 241 F.2d at 720, 112 USPQ at 475, examination of our precedent illustrates the degree of proof which we have deemed sufficient to establish practical utility in the past.

The facts in this case are substantially similar to those in Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed.Cir.1985). There, we expressly held that, in appropriate circumstances, evidence of in vitro testing could adequately establish a practical utility.5 As we there explained:

We perceive no insurmountable difficulty, under appropriate circumstances, in finding that the first link in the screening chain, in vitro testing, may establish a practical utility for the compound in question.... [U]nder the circumstances of the instant case, where [an application] discloses an in vitro utility, ... and where the disclosed in vitro utility is supplemented by the similar in vitro and in vivo pharmacological activity of structurally similar compounds, ... we agree with the Board that this in vitro utility is sufficient to [establish utility].

Id. at 1051, 224 USPQ at 748. Thus, Cross holds that positive in vitro results, in combination with a known correlation between such in vitro results and in vivo activity, may be sufficient to establish practical utility.

Fujikawa does not argue that the law as stated in Cross is incorrect. Instead, Fujikawa contends that Wattanasin has failed to establish an adequate correlation between in vitro and in vivo results in the field of cholesterol-inhibiting compounds to permit Wattanasin to rely on affirmative in vitro results to establish a practical utility for the compound.

The Board determined that Wattanasin had reduced the compound count to practice in October 1987 when several compounds falling within the scope of the genus count exhibited activity in vitro. In reaching that conclusion, the Board relied on testimony from those skilled in the art that the in vitro results convinced them that the claimed compounds would exhibit the desired pharmacological activity when administered in vivo. This included testimony that "in vivo activity is typically highly correlatable to a compound's in vitro activity" in this field. The facts in this case are thus analogous to the ones in Cross where the court relied on positive in vitro test results in combination with a known correlation between such in vitro tests and in vivo activity to support a finding of practical utility.

To counter the Board's decision, Fujikawa points to the testimony of its own expert, Dr. Holmlund, who testified that:

there is a reasonable element of doubt that some elements may be encountered which are active in the in vitro assay, but yet inactive in the in vivo assay.

According to Fujikawa, this testimony establishes that the in vitro tests were insufficient to prove practical utility.

We note first that to the extent the record presents a conflict in the testimony, the Board was well within its discretion as fact finder to credit the testimony of Wattanasin's witnesses over that of Fujikawa's. More fundamentally, however, we do not consider Dr. Holmlund's testimony as a whole to contradict the Board's finding. Of course, it is possible that some compounds active in vitro may not be active in vivo. But, as our predecessor court in Nelson explained, a "rigorous correlation" need not be shown in order to establish practical utility; "reasonable correlation" suffices. Here, even Dr. Holmlund implied in the question and answer immediately following the above quoted portion of his testimony, that such a "reasonable correlation" exists:


Q. Would you accept, subject to exceptions that might occur, that the failure to find [in vivo] activity would be considered an exception, that there would be a reasonable expectancy [that in vitro activity implies that the compound will be active in vivo]?

A. I think I would probably accept that.

Fujikawa also cites two articles6 which it claims show that there is no reliable relationship between in vitro results and in vivo results in cholesterol inhibiting compounds similar to the ones at issue in this case. We disagree. Although the Sliskovic article, for example, teaches that in vitro testing is sometimes not a good indicator of how potent a compound will be in vivo, it does imply that compounds which are active in vitro will normally exhibit some in vivo activity. See Sliskovic, at 370. Similarly, the Kathawala article expressly states: "For most substances, although not for all, the relative potency determined in in vitro microsomal assay against HMG-CoA reductase parallels the in vivo activity in rats for the inhibition of 14C-acetate into sterols." Kathawala at 136-37. On these facts, we hold that the Board did not err in finding that Wattanasin's in vitro tests established a practical utility for the genus recited in the compound count.

B

Turning to the method count, the Board found that Wattanasin reduced the method to practice in December 1987 when successful in vivo testing of the compound was completed. This finding, too, was based on testimony that the in vivo data for one of the compounds tested, 64-935, showed significant cholesterol inhibiting activity in the laboratory rats tested.

Fujikawa challenges the Board's holding by referring to an anomaly in the test data of the 64-935 compound which it contends undercuts the reliability of the in vivo tests. In particular, Fujikawa points to the fact that the compound's potency was less at a dosage of 0.3 mg than it was at a dosage of 0.1 mg. On the basis of this aberration, Fujikawa's expert, Dr. Holmlund, testified that this test data was unreliable and could not support a finding that the compound was pharmacologically active.

It is clear from the Board's opinion, however, that to the extent Dr. Holmlund was testifying that this aberration would lead one of ordinary skill to completely reject these test results, the Board did not accept his testimony. This decision of the Board was not clear error. Admittedly, the decreased potency at 0.3 mg is curious. The question remains, however, as to how much this glitch in the data would undercut the persuasiveness of the test results as a whole in the mind of one of ordinary skill. Each party presented evidence on this point and the Board resolved this disputed question of fact by finding that the test results as a whole were sufficient to establish pharmacological activity in the minds of those skilled in the art. In doing so, the Board properly exercised its duty as fact finder, and we therefore affirm its finding on this point.

As noted above, Fujikawa does not challenge the Board's conclusions that Wattanasin conceived prior to Fujikawa's effective date or that Wattanasin pursued the invention with diligence from just prior to Fujikawa's date until his reductions to practice in October and December 1987. Consequently, we affirm the Board's finding that Wattanasin has shown conception coupled with diligence from just prior to Fujikawa's effective date of August 20, 1987 up to the date he reduced the invention to practice in October 1987, for the compound, or December 1987, for the method.

IV

Having determined that Wattanasin was the de facto first inventor, the remaining question before the Board was whether Wattanasin had suppressed or concealed the invention between the time he reduced to practice and the time he filed his patent application. Suppression or concealment of the invention by Wattanasin would entitle Fujikawa to priority. 35 U.S.C. § 102(g).


Suppression or concealment is a question of law which we review de novo. Brokaw v. Vogel, 57 C.C.P.A. 1296, 429 F.2d 476, 480, 166 USPQ 428, 431 (1970). Our case law distinguishes between two types of suppression and concealment: cases in which the inventor deliberately suppresses or conceals his invention, and cases in which a legal inference of suppression or concealment is drawn based on "too long" a delay in filing a patent application. Paulik v. Rizkalla, 760 F.2d 1270, 1273, 226 USPQ 224, 226 (Fed.Cir. 1985) (in banc).

Fujikawa first argues that there is evidence of intentional suppression or concealment in this case. Intentional suppression refers to situations in which an inventor "designedly, and with the view of applying it indefinitely and exclusively for his own profit, withholds his invention from the public." Id. (quoting Kendall v. Winsor, 62 U.S. (21 How.) 322, 328, 16 L.Ed. 165 (1858)). Admittedly, Sandoz was not overly efficient in preparing a patent application, given the time which elapsed between its reduction to practice in late 1987 and its ultimate filing in March 1989. Intentional suppression, however, requires more than the passage of time. It requires evidence that the inventor intentionally delayed filing in order to prolong the period during which the invention is maintained in secret. Cf. Peeler v. Miller, 535 F.2d 647, 653-54, 190 USPQ 117, 122 (CCPA 1976) (implying that intentional suppression requires showing of specific intent). Fujikawa presented no evidence that Wattanasin delayed filing for this purpose. On the contrary, all indications are that throughout the period between reduction to practice and filing, Sandoz moved slowly (one might even say fitfully), but inexorably, toward disclosure. We therefore hold that Wattanasin did not intentionally suppress or conceal the invention in this case.

Absent intentional suppression, the only question is whether the 17 month period between the reduction to practice of the compound, or the 15 month period between reduction to practice of the method, and Wattanasin's filing justify an inference of suppression or concealment. See id. The Board held that these facts do not support such an inference. As the Board explained: "In our view, this hiatus in time is not sufficiently long to raise the inference that Wattanasin suppressed or concealed the invention considering the nature and complexity of the invention here."

Fujikawa attacks this finding of the Board on two grounds. First, it contends that the Board should not have held that a 15 or 17 month delay is per se insufficient to raise an inference of suppression or concealment without examining the circumstances surrounding the delay and whether, in view of those circumstances, Wattanasin's delay was reasonable. Second, Fujikawa argues that the Board failed to consider evidence that Wattanasin was spurred to file by the issuance of a patent to a third party, Picard, directed to the same genus of compounds invented by Wattanasin. Evidence that a first inventor was spurred to disclose by the activities of a second inventor has always been an important factor in priority determinations because it creates an inference that, but for the efforts of the second inventor, "the public would never have gained knowledge of [the invention]." Brokaw, 429 F.2d at 480, 166 USPQ at 431. Here, however, the Board expressly declined to consider the evidence of spurring because it held that spurring by a third party who is not a party to the interference is irrelevant to a determination of priority as between Wattanasin and Fujikawa. We first address Fujikawa's arguments concerning spurring.

A

We are not certain that the Board is correct that third party spurring is irrelevant in determining priority. After all, "[w]hat is involved here is a policy question as to which of the two rival inventors has the greater right to a patent." Brokaw, 429 F.2d at 480, 166 USPQ at 430. Resolution of this question could well be affected by the fact that one of the inventors chose to maintain his invention in secrecy until disclosure by another spurred him to file, even when the spurrer was a third party not involved in the interference. We need not resolve that question here, however, because we hold that no reasonable fact finder could have found spurring on the facts of this case. The only evidence in the record on the question of spurring is the testimony of Ms. Geisser who expressly testified that she had already begun work on the Wattanasin draft


application before she learned of Picard's patent, in other words, that she had not been spurred by Picard. Consequently, we leave the question of the relevance of third party spurring for another case.

B

Fujikawa's other argument also requires us to examine the evidence of record in this case. As Fujikawa correctly notes, this court has not set strict time limits regarding the minimum and maximum periods necessary to establish an inference of suppression or concealment. See Correge v. Murphy, 705 F.2d 1326, 1330, 217 USPQ 753, 756 (Fed.Cir.1983). Rather, we have recognized that "it is not the time elapsed that is the controlling factor but the total conduct of the first inventor." Young v. Dworkin, 489 F.2d 1277, 1285, 180 USPQ 388, 395 (CCPA 1974) (Rich, J., concurring). Thus, the circumstances surrounding the first inventor's delay and the reasonableness of that delay are important factors which must be considered in deciding questions of suppression or concealment. See, e.g., id. at 1281-82, 180 USPQ at 392-93. Fujikawa again correctly notes that the Board's opinion gives short shrift to the question of whether this delay on the facts of this case was reasonable. In seeking reversal of the Board's decision, Fujikawa asks us to assess the factual record for ourselves to determine whether Wattanasin engaged in sufficient disclosure-related activity to justify his 17-month delay in filing. The facts of record, however, do not support Fujikawa's position.

In our view, the circumstances in this case place it squarely within the class of cases in which an inference of suppression or concealment is not warranted. We acknowledge, of course, that each case of suppression or concealment must be decided on its own facts. Still, the rich and varied case law which this court has developed over many years provides some guidance as to the type of behavior which warrants an inference of suppression or concealment. See Paulik, 760 F.2d at 1280, 226 USPQ at 231-32 (Rich, J., concurring). In this case Wattanasin delayed approximately 17 months between reduction to practice and filing. During much of that period, however, Wattanasin and Sandoz engaged in significant steps towards perfecting the invention and preparing an application. For example, we do not believe any lack of diligence can be ascribed to Wattanasin for the period between October and December 1987 when in vivo testing of the invention was taking place. See Young, 489 F.2d at 1281, 180 USPQ at 392. Similarly, at its first opportunity following the in vivo testing, the Sandoz patent committee approved Wattanasin's invention for filing. This takes us up to the end of January 1988.

Over the next several months, until May 1988, the Sandoz patent department engaged in the necessary collection of data from the inventor and others in order to prepare Wattanasin's patent application. We are satisfied from the record that this disclosure-related activity was sufficient to avoid any inference of suppression or concealment during this period.8 Cf. Correge, 705 F.2d at 1330-31, 217 USPQ at 756 (five significant acts of disclosure-related activity over the course of seven months sufficient to rebut any inference of suppression). Also, as noted above, the record indicates that by August 1988, Ms. Geisser was already at work preparing the application, and that work continued on various drafts until Wattanasin's filing date in March 1989. Thus, the only real period of unexplained delay in this case is the approximately three month period between May and August of 1988.

Given a total delay of 17 months, an unexplained delay of three months, the complexity of the subject matter at issue, and our sense from the record as a whole that throughout the delay Sandoz was moving, albeit slowly, towards filing an application, we conclude that this case does not warrant an inference of suppression or concealment. Consequently, we affirm the Board on this point.

C

Finally, Fujikawa contends that assuming in vitro tests are sufficient to establish reduction to practice, Wattanasin reduced the compound count to practice in 1984 when he completed in vitro testing of his first


three compounds falling within the scope of the count. If so, Fujikawa argues, the delay between reduction to practice and filing was greater than four years, and an inference of suppression or concealment is justified.

We reject this argument in view of Paulik v. Rizkalla, 760 F.2d 1270, 226 USPQ 224 (Fed.Cir.1985) (in banc). In Paulik, we held that a suppression or concealment could be negated by renewed activity prior to an opposing party's effective date. There, inventor Paulik reduced his invention to practice and submitted an invention disclosure to his employer's patent department. For four years the patent department did nothing with the disclosure. Then, just two months before Rizkalla's effective date, the patent department allegedly picked up Paulik's disclosure and worked diligently to prepare a patent application which it ultimately filed. See id. at 1271-72, 226 USPQ at 224-25. We held that although Paulik could not rely on his original date of reduction to practice to establish priority, he could rely on the date of renewed activity in his priority contest with Rizkalla. In large measure, this decision was driven by the court's concern that denying an inventor the benefit of his renewed activity, might "discourage inventors and their supporters from working on projects that had been `too long' set aside, because of the impossibility of relying, in a priority contest, on either their original work or their renewed work." Id. at 1275-76, 226 USPQ at 227-28.

Paulik's reasoning, if not its holding, applies squarely to this case. A simple hypothetical illustrates why this is so. Imagine a situation similar to the one facing Sandoz in early 1987. A decisionmaker with limited funds must decide whether additional research funds should be committed to a project which has been neglected for over two years. In making this decision, the decisionmaker would certainly take into account the likelihood that the additional research might yield valuable patent rights. Furthermore, in evaluating the probability of securing those patent rights, an important consideration would be the earliest priority date to which the research would be entitled, especially in situations where the decisionmaker knows that he and his competitors are "racing" toward a common goal. Thus, the right to rely on renewed activity for purposes of priority would encourage the decisionmaker to fund the additional research. Conversely, denying an inventor the benefit of renewed activity would discourage the decisionmaker from funding the additional research.

Here, Wattanasin returned to his abandoned project well before Fujikawa's effective date and worked diligently towards reducing the invention to practice a second time. For the reasons explained above, we hold that, on these facts, Wattanasin's earlier reduction to practice in 1984 does not bar him from relying on his earliest date of renewed activity for purposes of priority.

V

Fujikawa also appeals the Board's decision denying Fujikawa's motion to add a sub-genus count to the interference. The Board denied the motion because it found that Wattanasin's disclosure did not sufficiently describe Fujikawa's proposed count. Whether a disclosure contains a sufficient written description to support a proposed count, is a question of fact which we review for clear error. Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed.Cir.1985). We affirm the Board's denial of Fujikawa's motion because we do not believe it was clearly erroneous.

Wattanasin's application disclosed compounds of the following structure:

wherein each of R and R0 is, independently, C1-6 alkyl (primary, secondary, or tertiary), C3-7 cycloalkyl, or the following ring, and each of R1, R2, R3, R4, and R5 is, independently, hydrogen, C1-4alkyl, C1-4alkoxy, trifluoromethyl, fluoro, chloro, phenoxy, benzyloxy, or hydroxy.

In addition to this genus of compounds, Wattanasin disclosed as his preferred embodiments that: R1 and R2 are most preferably hydrogen, R0 is most preferably phenyl, 4-fluorophenyl, or 3,5-dimethylphenyl; and R is most preferably methyl10 or isopropyl.11


Essentially, Fujikawa's proposed sub-genus is directed to compounds of the above structure in which R is cyclopropyl12 and R0 is 4-fluorophenyl. In other respects, the parties do not dispute that the particular constituents recited in Fujikawa's proposed count are adequately disclosed in Wattanasin's application. Thus, for example, both Wattanasin's most preferred embodiment and Fujikawa's proposed count describe R1 and R2 as hydrogen.

In denying Fujikawa's motion, the Board first noted that the proposed sub-genus was not disclosed ipsis verbis by Wattanasin. Specifically, the Board noted that Wattanasin preferred methyl and isopropyl for R, rather than cyclopropyl as in the proposed count. In addition, Wattanasin listed three preferred choices for R0 only one of which was 4-fluorophenyl and gave no indication in his application as to whether he would prefer any one of the choices over the other two.

As the Board recognized, however, ipsis verbis disclosure is not necessary to satisfy the written description requirement of section 112. Instead, the disclosure need only reasonably convey to persons skilled in the art that the inventor had possession of the subject matter in question. In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). In other words, the question is whether Wattanasin's "application provides adequate direction which reasonably [would lead] persons skilled in the art" to the sub-genus of the proposed count. Id. at 1352, 196 USPQ at 467.

Many years ago our predecessor court graphically articulated this standard by analogizing a genus and its constituent species to a forest and its trees. As the court explained:

It is an old custom in the woods to mark trails by making blaze marks on the trees. It is no help in finding a trail ... to be confronted simply by a large number of unmarked trees. Appellants are pointing to trees. We are looking for blaze marks which single out particular trees. We see none.

In finding that Wattanasin's disclosure failed to sufficiently describe the proposed sub-genus, the Board again recognized that the compounds of the proposed count were not Wattanasin's preferred, and that his application contained no blazemarks as to what compounds, other than those disclosed as preferred, might be of special interest. In the absence of such blazemarks, simply describing a large genus of compounds is not sufficient to satisfy the written description requirement as to particular species or sub-genuses. See, e.g., id. 379 F.2d at 994, 154 USPQ at 122 ("Specific claims to single compounds require reasonably specific supporting disclosure and while ... naming [each species] is not essential, something more than the disclosure of a class of 1000, or 100, or even 48 compounds is required.").

Before this court, Fujikawa challenges the Board's denial of its motion on two grounds. First, Fujikawa persists in arguing that its proposed count is disclosed ipsis verbis in Wattanasin's application. The basis for this contention seems to be that Wattanasin lists cyclopropyl as one possible moiety for R in his disclosure of the genus. Clearly, however, just because a moiety is listed as one possible choice for one position does not mean there is ipsis verbis support for every species or sub-genus that chooses that moiety. Were this the case, a "laundry list" disclosure of every possible moiety for every possible position would constitute a written description of every species in the genus. This cannot be because such a disclosure would not "reasonably lead" those skilled in the art to any particular species. We therefore reject Fujikawa's argument on this point.

Second, Fujikawa claims that the Board erred in finding that Wattanasin's disclosure contained insufficient blazemarks to direct one of ordinary skill to the compounds of its proposed count. Specifically, Fujikawa points out that with respect to practically every position on the compound, the proposed count recites at least one of Wattanasin's preferred choices. Even with respect to position R, Fujikawa further explains, one of ordinary skill would have been moved by Wattanasin's disclosure to substitute cyclopropyl for isopropyl because the two substituents are isosteric.


While Fujikawa's arguments are not without merit, we cannot say, on this record, that the Board's decision was clearly erroneous. As the Board pointed out, Fujikawa's proposed sub-genus diverges from Wattanasin's preferred elements at least with respect to position R. Although, in hindsight, the substitution of cyclopropyl for isopropyl might seem simple and foreseeable, Wattanasin's disclosure provides no indication that position R would be a better candidate for substitution than any other. Thus, faced with Wattanasin's disclosure, it was not clear error to hold that one of ordinary skill would not be led to Fujikawa's sub-genus in particular.

Were we to extend Ruschig's metaphor to this case, we would say that it is easy to bypass a tree in the forest, even one that lies close to the trail, unless the point at which one must leave the trail to find the tree is well marked. Wattanasin's preferred embodiments do blaze a trail through the forest; one that runs close by Fujikawa's proposed tree. His application, however, does not direct one to the proposed tree in particular, and does not teach the point at which one should leave the trail to find it. We therefore affirm the Board's denial of Fujikawa's motion.

VI

For the reasons we set forth above, the decision of the Board is, in all respects,

AFFIRMED.

• case: In re Brana

51 F.3d 1560 (1995)

In re Miguel F. BRANA, Jose M.C. Berlanga, Marina M. Moset, Erich Schlick and Gerhard Keilhauer.

United States Court of Appeals, Federal Circuit.

March 30, 1995.

Malcolm J. MacDonald, Keil & MacDonald, Washington, DC, argued, for appellant. With him on the brief was Herbert B. Keil. Of counsel was David S. Nagy.

Fred E. McKelvey, Sol., Office of Sol., Arlington, VA, argued, for appellee. With him on the brief were Albin F. Drost, Deputy Sol., Richard E. Schafer, Teddy S. Gron, Joseph G. Piccolo and Richard L. Torczon, Associate Sols.

Before PLAGER, LOURIE, and RADER, Circuit Judges.

PLAGER, Circuit Judge.

Miguel F. Brana, et al. (applicants), appeal the March 19, 1993 decision of the United States Patent and Trademark Office (PTO) Board of Patent Appeals and Interferences (Board), in Appeal No. 92-1196. The Board affirmed the examiner's rejection of claims 10-13 of patent application Serial No. 533,944 under 35 U.S.C. § 112 ¶ 1 (1988).1 The examiner's rejection, upon which the Board relied in rendering its decision, was based specifically on a challenge to the utility of the claimed compounds and the amount of experimentation necessary to use the compounds. We conclude the Board erred, and reverse.


I. BACKGROUND

On June 30, 1988, applicants filed patent application Serial No. 213,690 (the '690 application)2 directed to 5-nitrobenzo[de]isoquinoline-1,3-dione compounds, for use as antitumor substances, having the following formula:

where n is 1 or 2, R1 and R2 are identical or different and are each hydrogen, C1-C6-alkyl, C1-C6-hydroxyalkyl, pyrrolidinyl, morpholino, piperidinyl or piperacinyl, and R3 and R4 are identical or different and are each hydrogen, C1-C6-alkyl, C1-C6-acyl, C2-C7-alkoxycarbonyl, ureyl, aminocarbonyl or C2-C7-alkylaminocarbonyl. These claimed compounds differ from several prior art benzo[de]isoquinoline-1,3-dione compounds due to the presence of a nitro group (O2N) at the 5-position and an amino or other amino group (NR3R4) at the 8-position of the isoquinoline ring.

The specification states that these non-symmetrical substitutions at the 5- and 8- positions produce compounds with "a better action and a better action spectrum as antitumor substances" than known benzo[de]isoquinolines, namely those in K.D. Paull et al., Computer Assisted Structure-Activity Correlations, Drug Research, 34(II), 1243-46 (1984) (Paull). Paull describes a computer-assisted evaluation of benzo[de]isoquinoline-1,3-diones and related compounds which have been screened for antitumor activity by testing their efficacy in vivo3 against two specific implanted murine (i.e., utilizing mice as test subjects) lymphocytic leukemias, P388 and L1210.4 These two in vivo tests are widely used by the National Cancer Institute (NCI) to measure the antitumor properties of a compound. Paull noted that one compound in particular, benzo[de]isoquinoline-1,3(2H)dione,5-amino-2(2-dimethyl-aminoe-thyl [sic]) (hereinafter "NSC 308847"), was found to show excellent activity against these two specific tumor models. Based on their analysis, compound NSC 308847 was selected for further studies by NCL. In addition to comparing the effectiveness of the claimed compounds with structurally similar compounds in Paull, applicants' patent specification illustrates the cytotoxicity of the claimed compounds against human tumor cells, in vitro,5 and concludes that these tests "had a good action."

The examiner initially rejected applicants' claims in the '690 application as obvious under 35 U.S.C. § 103 in light of U.S. Patent No. 4,614,820, issued to and referred to hereafter as Zee-Cheng et al. Zee-Cheng et al. discloses a benzo[de]isoquinoline compound for use as an antitumor agent with symmetrical substitutions on the 5-position and 8-position of the quinoline ring; in both positions the substitution was either an amino or nitro group.7 Although not identical to the applicants' claimed compounds, the examiner noted the similar substitution pattern (i.e., at the same positions on the isoquinoline ring) and concluded that a mixed substitution of the invention therefore would have been obvious in view of Zee-Cheng et al.

In a response dated July 14, 1989, the applicants rebutted the § 103 rejection. Applicants asserted that their mixed disubstituted compounds had unexpectedly better antitumor properties than the symmetrically substituted compounds in Zee-Cheng et al. In support of this assertion applicants attached the declaration of Dr. Gerhard Keilhauer. In his declaration Dr. Keilhauer reported that his tests indicated that applicants' claimed compounds were far more effective as antitumor agents than the compounds disclosed in Zee-Cheng et al. when tested, in vitro, against two specific types of human tumor cells, HEp and HCT-29.8 Applicants further noted that, although the differences between the compounds in Zee-Cheng et al. and applicants' claimed compounds were slight, there was no suggestion in the art that these improved results (over Zee-Cheng et al.) would have been expected. Although the applicants overcame the § 103 rejection, the examiner nevertheless issued a final rejection, on different grounds, on September 5, 1989.

On June 4, 1990, applicants filed a continuation application, Serial No. 533,944 (the '944 application), from the above-mentioned '690 application. Claims 10-13, the only claims remaining in the


continuation application, were rejected in a final office action dated May 1, 1991. Applicants appealed the examiner's final rejection to the Board.

In his answer to the applicants' appeal brief, the examiner stated that the final rejection was based on 35 U.S.C. § 112 ¶ 1.9 The examiner first noted that the specification failed to describe any specific disease against which the claimed compounds were active. Furthermore, the examiner concluded that the prior art tests performed in Paull and the tests disclosed in the specification were not sufficient to establish a reasonable expectation that the claimed compounds had a practical utility (i.e. antitumor activity in humans).10

In a decision dated March 19, 1993, the Board affirmed the examiner's final rejection. The three-page opinion, which lacked any additional analysis, relied entirely on the examiner's reasoning. Although noting that it also would have been proper for the examiner to reject the claims under 35 U.S.C. § 101, the Board affirmed solely on the basis of the Examiner's § 112 ¶ 1 rejection. This appeal followed.

II. DISCUSSION

At issue in this case is an important question of the legal constraints on patent office examination practice and policy. The question is, with regard to pharmaceutical inventions, what must the applicant prove regarding the practical utility or usefulness of the invention for which patent protection is sought. This is not a new issue; it is one which we would have thought had been settled by case law years ago.11 We note the Commissioner has recently addressed this question in his Examiner Guidelines for Biotech Applications, see 60 Fed.Reg. 97 (1995); 49 Pat.Trademark & Copyright J. (BNA) No. 1210, at 234 (Jan. 5, 1995).

The requirement that an invention have utility is found in 35 U.S.C. § 101: "Whoever invents ... any new and useful ... composition of matter ... may obtain a patent therefor. ..." (emphasis added). It is also implicit in § 112 ¶ 1, which reads:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

Obviously, if a claimed invention does not have utility, the specification cannot enable one to use it.

As noted, although the examiner and the Board both mentioned § 101, and the rejection appears to be based on the issue of whether the compounds had a practical utility, a § 101 issue, the rejection according to the Board stands on the requirements of § 112 ¶ 1. It is to that provision that we address ourselves.12 The Board gives two reasons for the rejection;13 we will consider these in turn.

1.

The first basis for the Board's decision was that the applicants' specification failed to disclose a specific disease against which the claimed compounds are useful, and therefore, absent undue experimentation, one of ordinary skill in the art was precluded from using the invention. See Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed.Cir.1986), cert. denied, 480 U.S. 947, 107 S.Ct. 1606, 94 L.Ed.2d 792 (1987). In support, the Commissioner argues that the disclosed uses in the '944 application, namely the "treatment of diseases" and "antitumor substances," are similar to the nebulous disclosure found insufficient in In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967). This argument is not without merit.


In Kirk applicants claimed a new class of steroid compounds. One of the alleged utilities disclosed in the specification was that these compounds possessed "high biological activity." Id. at 938, 153 USPQ at 50. The specification, however, failed to disclose which biological properties made the compounds useful. Moreover, the court found that known specific uses of similar compounds did not cure this defect since there was no disclosure in the specification that the properties of the claimed compounds were the same as those of the known similar compounds. Id. at 942, 153 USPQ at 53. Furthermore, it was not alleged that one of skill in the art would have known of any specific uses, and therefore, the court concluded this alleged use was too obscure to enable one of skill in the art to use the claimed invention. See also Kawai v. Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973).

Kirk would potentially be dispositive of this case were the above-mentioned language the only assertion of utility found in the '944 application. Applicants' specification, however, also states that the claimed compounds have "a better action and a better action spectrum as antitumor substances" than known compounds, specifically those analyzed in Paull. As previously noted, see supra note 4, Paull grouped various benzo[de]isoquinoline-1,3-diones, which had previously been tested in vivo for antitumor activity against two lymphocytic leukemia tumor models (P388 and L1210), into various structural classifications and analyzed the test results of the groups (i.e. what percent of the compounds in the particular group showed success against the tumor models). Since one of the tested compounds, NSC 308847, was found to be highly effective against these two lymphocytic leukemia tumor models,14 applicants' favorable comparison implicitly asserts that their claimed compounds are highly effective (i.e. useful) against lymphocytic leukemia. An alleged use against this particular type of cancer is much more specific than the vaguely intimated uses rejected by the courts in Kirk and Kawai. See, e.g., Cross v. Iizuka, 753 F.2d at 1048, 224 USPQ at 745 (finding the disclosed practical utility for the claimed compounds — the inhibition of thromboxane synthetase in human or bovine platelet microsomes — sufficiently specific to satisfy the threshold requirement in Kirk and Kawai.)

The Commissioner contends, however, that P388 and L1210 are not diseases since the only way an animal can get sick from P388 is by a direct injection of the cell line. The Commissioner therefore concludes that applicants' reference to Paull in their specification does not provide a specific disease against which the claimed compounds can be used. We disagree.

As applicants point out, the P388 and L1210 cell lines, though technically labeled tumor models, were originally derived from lymphocytic leukemias in mice. Therefore, the P388 and L1210 cell lines do represent actual specific lymphocytic tumors; these models will produce this particular disease once implanted in mice. If applicants were required to wait until an animal naturally developed this specific tumor before testing the effectiveness of a compound against the tumor in vivo, as would be implied from the Commissioner's argument, there would be no effective way to test compounds in vivo on a large scale.

We conclude that these tumor models represent a specific disease against which the claimed compounds are alleged to be effective. Accordingly, in light of the explicit reference to Paull, applicants' specification alleges a sufficiently specific use.

2.

The second basis for the Board's rejection was that, even if the specification did allege a specific use, applicants failed to prove that the claimed compounds are useful. Citing various references,15 the Board found, and the Commissioner now argues, that the tests offered by the applicants to prove utility were inadequate to convince one of ordinary skill in the art that the claimed compounds are useful as antitumor agents.


This court's predecessor has stated:

[A] specification disclosure which contains a teaching of the manner and process of making and using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support. (In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971).

From this it follows that the PTO has the initial burden of challenging a presumptively correct assertion of utility in the disclosure. Id. at 224, 169 USPQ at 370. Only after the PTO provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince such a person of the invention's asserted utility. See In re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA 1981).

The PTO has not met this initial burden. The references cited by the Board, Pazdur and Martin,18 do not question the usefulness of any compound as an antitumor agent or provide any other evidence to cause one of skill in the art to question the asserted utility of applicants' compounds. Rather, these references merely discuss the therapeutic predictive value of in vivo murine tests — relevant only if applicants must prove the ultimate value in humans of their asserted utility. Likewise, we do not find that the nature of applicants' invention alone would cause one of skill in the art to reasonably doubt the asserted usefulness.

The purpose of treating cancer with chemical compounds does not suggest an inherently unbelievable undertaking or involve implausible scientific principles. In re Jolles, 628 F.2d at 1327, 206 USPQ at 890. Modern science has previously identified numerous successful chemotherapeutic agents. In addition, the prior art, specifically Zee Cheng et al., discloses structurally similar compounds to those claimed by the applicants which have been proven in vivo to be effective as chemotherapeutic agents against various tumor models.

Taking these facts — the nature of the invention and the PTO's proffered evidence — into consideration we conclude that one skilled in the art would be without basis to reasonably doubt applicants' asserted utility on its face. The PTO thus has not satisfied its initial burden. Accordingly, applicants should not have been required to substantiate their presumptively correct disclosure to avoid a rejection under the first paragraph of § 112. See In re Marzocchi, 439 F.2d at 224, 169 USPQ at 370.

We do not rest our decision there, however. Even if one skilled in the art would have reasonably questioned the asserted utility, i.e., even if the PTO met its initial burden thereby shifting the burden to the applicants to offer rebuttal evidence, applicants proffered sufficient evidence to convince one of skill in the art of the asserted utility. In particular, applicants provided through Dr. Kluge's declaration19 test results showing that several compounds within the scope of the claims exhibited significant antitumor activity against the L1210 standard tumor model in vivo. Such evidence alone should have been sufficient to satisfy applicants' burden.

The prior art further supports the conclusion that one skilled in the art would be convinced of the applicants' asserted utility. As previously mentioned, prior art — Zee Cheng et al. and Paull — disclosed structurally similar compounds which were proven in vivo against various tumor models to be effective as chemotherapeutic agents. Although it is true that minor changes in chemical compounds can radically alter their effects on the human body, Kawai, 480 F.2d at 891, 178 USPQ at 167, evidence of success in structurally similar compounds is relevant in determining whether one skilled in the art would


believe an asserted utility. See Rey-Bellet v. Engelhardt, 493 F.2d 1380, 181 USPQ 453 (CCPA 1974); Kawai, 480 F.2d 880, 178 USPQ 158.

The Commissioner counters that such in vivo tests in animals are only preclinical tests to determine whether a compound is suitable for processing in the second stage of testing, by which he apparently means in vivo testing in humans, and therefore are not reasonably predictive of the success of the claimed compounds for treating cancer in humans.20 The Commissioner, as did the Board, confuses the requirements under the law for obtaining a patent with the requirements for obtaining government approval to market a particular drug for human consumption. See Scott v. Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 (Fed.Cir.1994) ("Testing for the full safety and effectiveness of a prosthetic device is more properly left to the Food and Drug Administration (FDA). Title 35 does not demand that such human testing occur within the confines of Patent and Trademark Office (PTO) proceedings.").

Our court's predecessor has determined that proof of an alleged pharmaceutical property for a compound by statistically significant tests with standard experimental animals is sufficient to establish utility. In re Krimmel, 292 F.2d 948, 953, 130 USPQ 215, 219 (CCPA 1961); see also In re Bergel, 292 F.2d 958, 130 USPQ 205 (CCPA 1961). In concluding that similar in vivo tests were adequate proof of utility the court in In re Krimmel stated:

We hold as we do because it is our firm conviction that one who has taught the public that a compound exhibits some desirable pharmaceutical property in a standard experimental animal has made a significant and useful contribution to the art, even though it may eventually appear that the compound is without value in the treatment in humans.

Krimmel, 292 F.2d at 953, 130 USPQ at 219. Moreover, NCI apparently believes these tests are statistically significant because it has explicitly recognized both the P388 and L1210 marine tumor models as standard screening tests for determining whether new compounds may be useful as antitumor agents.

In the context of this case the Martin and Pazdur references, on which the Commissioner relies, do not convince us otherwise. Pazdur only questions the reliability of the screening tests against lung cancer; it says nothing regarding other types of tumors. Although the Martin reference does note that some laboratory oncologists are skeptical about the predictive value of in vivo murine tumor models for human therapy, Martin recognizes that these tumor models continue to contribute to an increasing human care rate. In fact, the authors conclude that this perception (i.e. lack of predictive reliability) is not tenable in light of present information.

On the basis of animal studies, and controlled testing in a limited number of humans (referred to as Phase I testing), the Food and Drug Administration may authorize Phase II clinical studies. See 21 U.S.C. § 355(i)(1); 21 C.F.R. § 312.23(a)(5), (a)(8) (1994). Authorization for a Phase II study means that the drug may be administered to a larger number of humans, but still under strictly supervised conditions. The purpose of the Phase II study is to determine primarily the safety of the drug when administered to a larger human population, as well as its potential efficacy under different dosage regimes. See 21 C.F.R. § 312.21(b).

FDA approval, however, is not a prerequisite for finding a compound useful within the meaning of the patent laws. Scott, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120. Usefulness in patent law, and in particular in the context of pharmaceutical inventions, necessarily includes the expectation of further research and development. The stage at which an invention in this field becomes useful is well before it is ready to be administered to humans. Were we to require Phase II testing in order to prove utility, the associated costs would prevent many companies from obtaining patent protection on promising new


inventions, thereby eliminating an incentive to pursue, through research and development, potential cures in many crucial areas such as the treatment of cancer.

In view of all the foregoing, we conclude that applicants' disclosure complies with the requirements of 35 U.S.C. § 112 ¶ 1.

3.

The Commissioner takes this opportunity to raise the question of this court's standard of review when deciding cases on appeal from the PTO. Traditionally we have recited our standard of review to be, with regard to questions of law, that review is without deference to the views of the Agency, In re Donaldson, 16 F.3d 1189, 1192, 29 USPQ2d 1845, 1848 (Fed.Cir.1994) (in banc), In re Caveney, 761 F.2d 671, 674, 226 USPQ 1, 3 (Fed.Cir.1985), and with regard to questions of fact, we defer to the Agency unless its findings are "clearly erroneous." See, e.g., In re Baxter Travenol Labs, 952 F.2d 388, 21 USPQ2d 1281 (Fed.Cir.1991); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir.1990); In re De Blauwe, 736 F.2d 699, 222 USPQ 191 (Fed.Cir.1984).

With regard to judgment calls, those questions that fall "[s]omewhere near the middle of the fact-law spectrum," this court has recognized "the falseness of the fact-law dichotomy, since the determination at issue, involving as it does the application of a general legal standard to particular facts, is probably most realistically described as neither of fact nor law, but mixed." Campbell v. Merit Systems Protection Board, 27 F.3d 1560, 1565 (Fed.Cir.1994). When these questions of judgment are before us, whether we defer, and the extent to which we defer, turns on the nature of the case and the nature of the judgment. Id. ("Characterization therefore must follow from an a priori decision as to whether deferring ... is sound judicial policy. We would be less than candid to suggest otherwise.").

The Commissioner contends that the appropriate standard of review for this court regarding questions of law, of fact, and mixed questions of law and fact, coming to us from the PTO is found in the Administrative Procedure Act (APA) at 5 U.S.C. § 706. The standard set out there is that "[t]he reviewing court shall ... hold unlawful and set aside agency action, findings, and conclusions found to be — (A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; ... (E) unsupported by substantial evidence...." The Commissioner is of the view that the stated standard we now use, which is the traditional standard of review for matters coming from a trial court, is not appropriate for decisions coming from an agency with presumed expertise in the subject area, and is not in accord with law.

Applicants argue that by custom and tradition, recognized by the law of this court, the standard of review we have applied, even though inconsistent with the standard set forth in the APA, nevertheless is a permissible standard. In our consideration of this issue, there is a reality check: would it matter to the outcome in a given case which formulation of the standard a court articulates in arriving at its decision? The answer no doubt must be that, even though in some cases it might not matter, in others it would, otherwise the lengthy debates about the meaning of these formulations and the circumstances in which they apply would be unnecessary.

A preliminary question, then, is whether this is one of those cases in which a difference in the standard of review would make a difference in the outcome. The ultimate issue is whether the Board correctly applied the § 112 ¶ 1 enablement mandate and its implicit requirement of practical utility, or perhaps more accurately the underlying requirement of § 101, to the facts of this case. As we have explained, the issue breaks down into two subsidiary issues: (1) whether a person of ordinary skill in the art would conclude that the applicants had sufficiently described particular diseases addressed by the invention,


and (2) whether the Patent Act supports a requirement that makes human testing a prerequisite to patentability under the circumstances of this case.

The first subsidiary issue, whether the application adequately described particular diseases, calls for a judgment about what the various representations and discussions contained in the patent application's specification would say to a person of ordinary skill in the art. We have considered that question carefully, and, for the reasons we explained above in some detail, we conclude that the Board's judgment on this question was erroneous. Our conclusion rests on our understanding of what a person skilled in the art would gather from the various art cited, and from the statements in the application itself. We consider the Board's error to be sufficiently clear that it is reversible whether viewed as clear error or as resulting in an arbitrary and capricious decision.

The second subsidiary issue, whether human testing is a prerequisite to patentability, is a pure question of law: what does the practical utility requirement mean in a case of this kind. Under either our traditional standard or under the APA standard no deference is owed the Agency on a question of law, and none was accorded.

If the question concerning the standard of review, raised by the Commissioner, is to be addressed meaningfully, it must arise in a case in which the decision will turn on that question, and, recognizing this, the parties fully brief the issue. This is not that case. We conclude that it is not necessary to the disposition of this case to address the question raised by the Commissioner; accordingly, we decline the invitation to do so.

III. CONCLUSION

The Board erred in affirming the examiner's rejection under 35 U.S.C. § 112 ¶ 1. The decision is reversed.

REVERSED.

• case: In re Fisher

United States Court of Appeals for the Federal Circuit

September 7, 2005

IN RE DANE K. FISHER AND RAGHUNATH V. LALGUDI

Appealed from: United States Patent and Trademark Office Board of Patent Appeals and Interferences. The opinion of the court was delivered by: Michel, Chief Judge.

(Serial No. 09/619,643)

Before MICHEL, Chief Judge, RADER and BRYSON, Circuit Judges.

Opinion for the court filed by Chief Judge MICHEL. Dissenting opinion filed by Circuit Judge RADER.

Dane K. Fisher and Raghunath Lalgudi (collectively "Fisher")*fn1 appeal from the decision of the U.S. Patent and Trademark Office ("PTO") Board of Patent Appeals and Interferences ("Board") affirming the examiner's final rejection of the only pending claim of application Serial No. 09/619,643 (the "'643 application"), entitled "Nucleic Acid Molecules and Other Molecules Associated with Plants," as unpatentable for lack of utility under 35 U.S.C. § 101 and lack of enablement under 35 U.S.C. § 112,

http://tx.findacase.com/research/wfrmDocViewer.aspx/xq/fac.20050907_0000438.cfc.htm/qx#D*fn1


first paragraph. Ex parte Fisher, App. No. 2002-2046 (Bd. Pat. App. Int. Mar. 16, 2004) ("Board Decision"). This appeal was submitted after oral argument on May 3, 2005. Because we conclude that substantial evidence supports the Board's findings that the claimed invention lacks a specific and substantial utility and that the '643 application does not enable one of ordinary skill in the art to use the invention, we affirm.

I. BACKGROUND

A. Molecular Genetics and ESTs

The claimed invention relates to five purified nucleic acid sequences that encode proteins and protein fragments in maize plants. The claimed sequences are commonly referred to as "expressed sequence tags" or "ESTs." Before delving into the specifics of this case, it is important to understand more about the basic principles of molecular genetics and the role of ESTs.

Genes are located on chromosomes in the nucleus of a cell and are made of deoxyribonucleic acid ("DNA"). DNA is composed of two strands of nucleotides in double helix formation. The nucleotides contain one of four bases, adenine ("A"), guanine ("G"), cytosine ("C"), and thymine ("T"), that are linked by hydrogen bonds to form complementary base pairs (i.e., A-T and G-C).

When a gene is expressed in a cell, the relevant double-stranded DNA sequence is transcribed into a single strand of messenger ribonucleic acid ("mRNA"). Messenger RNA contains three of the same bases as DNA (A, G, and C), but contains uracil ("U") instead of thymine. mRNA is released from the nucleus of a cell and used by ribosomes found in the cytoplasm to produce proteins.

Complementary DNA ("cDNA") is produced synthetically by reverse transcribing mRNA. cDNA, like naturally occurring DNA, is composed of nucleotides containing the four nitrogenous bases, A, T, G, and C. Scientists routinely compile cDNA into libraries to study the kinds of genes expressed in a certain tissue at a particular point in time.

One of the goals of this research is to learn what genes and downstream proteins are expressed in a cell so as to regulate gene expression and control protein synthesis.*fn2

An EST is a short nucleotide sequence that represents a fragment of a cDNA clone. It is typically generated by isolating a cDNA clone and sequencing a small number of nucleotides located at the end of one of the two cDNA strands. When an EST is introduced into a sample containing a mixture of DNA, the EST may hybridize with a portion of DNA. Such binding shows that the gene corresponding to the EST was being expressed at the time of mRNA extraction.

Claim 1 of the '643 application recites: A substantially purified nucleic acid molecule that encodes a maize protein or fragment thereof comprising a nucleic acid sequence selected from the group consisting of SEQ ID NO: 1 through SEQ ID NO: 5.

The ESTs set forth in SEQ ID NO: 1 through SEQ ID NO: 5 are obtained from cDNA library LIB3115, which was generated from pooled leaf tissue harvested from maize plants (RX601, Asgrow Seed Company, Des Moines, Iowa, U.S.A.) grown in the fields at Asgrow research stations. SEQ ID NO:1 through SEQ ID NO:5 consist of 429, 423, 365, 411, and 331 nucleotides, respectively. When Fisher filed the '643 application, he claimed ESTs corresponding to genes expressed from the maize pooled leaf tissue at the time of anthesis. Nevertheless, Fisher did not know the precise structure or function of either the genes or the proteins encoded for by those genes.

The '643 application generally discloses that the five claimed ESTs may be used in a variety of ways, including: (1) serving as a molecular marker for mapping the entire maize genome, which consists of ten chromosomes that collectively encompass roughly 50,000 genes; (2) measuring the level of mRNA in a tissue sample via microarray technology to provide information about gene expression; (3)



providing a source for primers for use in the polymerase chain reaction ("PCR") process to enable rapid and inexpensive duplication of specific genes; (4) identifying the presence or absence of a polymorphism; (5) isolating promoters via chromosome walking; (6) controlling protein expression; and (7) locating genetic molecules of other plants and organisms.

B. Final Rejection

In a final rejection, dated September 6, 2001, the examiner rejected claim 1 for lack of utility under § 101. The examiner found that the claimed ESTs were not supported by a specific and substantial utility. She concluded that the disclosed uses were not specific to the claimed ESTs, but instead were generally applicable to any EST. For example, the examiner noted that any EST may serve as a molecular tag to isolate genetic regions. She also concluded that the claimed ESTs lacked a substantial utility because there was no known use for the proteins produced as final products resulting from processes involving the claimed ESTs. The examiner stated: "Utilities that require or constitute carrying out further research to identify or reasonably confirm a 'real world' context of use are not substantial utilities."

The examiner also rejected the claimed application for lack of enablement under § 112, first paragraph. She reasoned that one skilled in the art would not know how to use the claimed ESTs because the '643 application did not disclose a specific and substantial utility for them.

On July 19, 2000, Fisher filed a notice of appeal with the Board.

C. Board Proceedings

The Board considered each of Fisher's seven potential uses but noted that Fisher focused its appeal on only two: (1) use for the identification of polymorphisms; and (2) use as probes or as a source for primers. As to the first, the Board found that the application failed to explain why the claimed ESTs would be useful in detecting polymorphisms in maize plants. Board Decision, slip op. at 14. The Board reasoned that "[w]ithout knowing any further information in regard to the gene represented by an EST, as here, detection of the presence or absence of a polymorphism provides the barest information in regard to genetic heritage." Id., slip op. at 15. Thus, the Board concluded that Fisher's asserted uses for the claimed ESTs tended to the "insubstantial use" end of the spectrum between a substantial and an insubstantial utility. Id.

The Board also concluded that using the claimed ESTs to isolate nucleic acid molecules of other plants and organisms, which themselves had no known utility, is not a substantial utility. Id., slip op. at 16. Specifically, the Board noted that Fisher argued that the "claimed ESTs may be useful in searching for promoters that are only active in leaves at the time of anthesis." Id. The Board found, however, that the application failed to show that the claimed ESTs would be expressed only during anthesis or that they would be capable of isolating a promoter active in maize leaves at the time of anthesis. Id., slip op. at 18.

Additionally, the Board addressed the remaining asserted utilities, highlighting in particular the use of the claimed ESTs to monitor gene expression by measuring the level of mRNA through microarray technology and to serve as molecular markers. The Board found that using the claimed ESTs in screens does not provide a specific benefit because the application fails to provide any teaching regarding how to use the data relating to gene expression. Id., slip op. at 21. The Board analogized the facts to those in Brenner v. Manson, 383 U.S. 519 (1966), in which an applicant claimed a process of making a compound having no known use. In that case, the Supreme Court affirmed the rejection of the application on § 101 grounds. Here, the Board reasoned: "Just as the process in Brenner lacked utility because the specification did not disclose how to use the end-product, the products claimed here lack utility, because even if used in gene expression assays, the specification does not disclose how to use SEQ ID NO: 1-5 specific gene expression data." Id., slip op. at 22. The Board offered a similar rationale for the use of the claimed ESTs as molecular markers. Id., slip op. at 24. Accordingly, the Board affirmed the examiner's rejection of the '643 application for lack of utility under § 101. The Board also


affirmed the examiner's rejection of the '643 application for lack of enablement under § 112, first paragraph, since the enablement rejection was made as a corollary to the utility rejection.

Fisher timely appealed. We have jurisdiction over this appeal pursuant to 28 U.S.C. § 1295(a)(4) and 35 U.S.C. §§ 141 and 144.

II. DISCUSSION

Whether an application discloses a utility for a claimed invention is a question of fact. In re Ziegler, 992 F.2d 1197, 1200 (Fed. Cir. 1993). We consequently review the Board's determination that the '643 application failed to satisfy the utility requirement of § 101 for substantial evidence. In re Gartside, 203 F.3d 1305, 1315 (Fed. Cir. 2000) ("Because our review of the Board's decision is confined to the factual record compiled by the Board, we accordingly conclude that the 'substantial evidence' standard is appropriate for our review of Board factfindings.").

A. Utility

1.

Fisher asserts that the Board unilaterally applied a heightened standard for utility in the case of ESTs, conditioning patentability upon "some undefined 'spectrum' of knowledge concerning the corresponding gene function." Fisher contends that the standard is not so high and that Congress intended the language of § 101 to be given broad construction. In particular, Fisher contends that § 101 requires only that the claimed invention "not be frivolous, or injurious to the well-being, good policy, or good morals of society," essentially adopting Justice Story's view of a useful invention from Lowell v. Lewis, 15 F. Cas. 1018, 1019 (No. 8568) (C.C. Mass. 1817). Under the correct application of the law, Fisher argues, the record shows that the claimed ESTs provide seven specific and substantial uses, regardless whether the functions of the genes corresponding to the claimed ESTs are known. Fisher claims that the Board's attempt to equate the claimed ESTs with the chemical compositions in Brenner was misplaced and that several decisions in the field of pharmaceuticals, namely, Cross v. Iizuka, 753 F.2d 1040 (Fed. Cir. 1985), Nelson v. Bowler, 626 F.2d 853 (C.C.P.A. 1980), and In re Jolles, 628 F.2d 1322 (C.C.P.A. 1980), are analogous and support finding utility of the claimed ESTs. Fisher likewise argues that the general commercial success of ESTs in the marketplace confirms the utility of the claimed ESTs. Hence, Fisher avers that the Board's decision was not supported by substantial evidence and should be reversed.

The government agrees with Fisher that the utility threshold is not high, but disagrees with Fisher's allegation that the Board applied a heightened utility standard. The government contends that a patent applicant need disclose only a single specific and substantial utility pursuant to Brenner, the very standard articulated in the PTO's "Utility Examination Guidelines" ("Utility Guidelines") and followed here when examining the '643 application. It argues that Fisher failed to meet that standard because Fisher's alleged uses are so general as to be meaningless. What is more, the government asserts that the same generic uses could apply not only to the five claimed ESTs but also to any EST derived from any organism. It thus argues that the seven utilities alleged by Fisher are merely starting points for further research, not the end point of any research effort. It further disputes the importance of the commercial success of ESTs in the marketplace, pointing out that Fisher's evidence involved only databases, clone sets, and microarrays, not the five claimed ESTs. Therefore, the government contends that we should affirm the Board's decision.

Several academic institutions and biotechnology and pharmaceutical companies*fn3 write as amici curiae in support of the government. Like the government, they assert that Fisher's claimed uses are nothing more than a "laundry list" of research plans, each general and speculative, none providing a specific and substantial benefit in currently available form. The amici also advocate that the claimed ESTs are the objects of further research aimed at identifying what genes of unknown function are expressed during anthesis and what proteins of unknown function are encoded for by those genes.



Until the corresponding genes and proteins have a known function, the amici argue, the claimed ESTs lack utility under § 101 and are not patentable.

We agree with both the government and the amici that none of Fisher's seven asserted uses meets the utility requirement of § 101. Section 101 provides: "Whoever invents . . . any new and useful . . . composition of matter . . . may obtain a patent therefor . . . ." (Emphasis added). In Brenner, the Supreme Court explained what is required to establish the usefulness of a new invention, noting at the outset that "a simple, everyday word ["useful," as found in § 101] can be pregnant with ambiguity when applied to the facts of life." 383 U.S. at 529. Contrary to Fisher's argument that § 101 only requires an invention that is not "frivolous, injurious to the well-being, good policy, or good morals of society," the Supreme Court appeared to reject Justice Story's de minimis view of utility. Id. at 532-33 (citation omitted). The Supreme Court observed that Justice Story's definition "sheds little light on our subject," on the one hand framing the relevant inquiry as "whether the invention in question is 'frivolous and insignificant'" if narrowly read, while on the other hand "allowing the patenting of any invention not positively harmful to society" if more broadly read. Id. at 533. In its place, the Supreme Court announced a more rigorous test, stating:

The basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility. Unless and until a process is refined and developed to this point -- where specific benefit exists in currently available form -- there is insufficient justification for permitting an applicant to engross what may prove to be a broad field.

Brenner, 383 U.S. at 534-35 (emphases added). Following Brenner, our predecessor court, the Court of Customs and Patent Appeals, and this court have required a claimed invention to have a specific and substantial utility to satisfy § 101. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1563 (Fed. Cir. 1996) ("Consequently, it is well established that a patent may not be granted to an invention unless substantial or practical utility for the invention has been discovered and disclosed.").

The Supreme Court has not defined what the terms "specific" and "substantial" mean per se. Nevertheless, together with the Court of Customs and Patent Appeals, we have offered guidance as to the uses which would meet the utility standard of § 101. From this, we can discern the kind of disclosure an application must contain to establish a specific and substantial utility for the claimed invention.

Courts have used the labels "practical utility" and "real world" utility interchangeably in determining whether an invention offers a "substantial" utility. Indeed, the Court of Customs and Patent Appeals stated that "'[p]ractical utility' is a shorthand way of attributing 'real-world' value to claimed subject matter. In other words, one skilled in the art can use a claimed discovery in a manner which provides some immediate benefit to the public." Nelson, 626 F.2d at 856 (emphasis added).*fn4 It thus is clear that an application must show that an invention is useful to the public as disclosed in its current form, not that it may prove useful at some future date after further research. Simply put, to satisfy the "substantial" utility requirement, an asserted use must show that that claimed invention has a significant and presently available benefit to the public.

Turning to the "specific" utility requirement, an application must disclose a use which is not so vague as to be meaningless. Indeed, one of our predecessor courts has observed "that the nebulous expressions 'biological activity' or 'biological properties' appearing in the specification convey no more explicit indication of the usefulness of the compounds and how to use them than did the equally obscure expression 'useful for technical and pharmaceutical purposes' unsuccessfully relied upon by the appellant in In re Diedrich." In re Kirk, 376 F.2d 936, 941 (C.C.P.A. 1967). Thus, in addition to providing a "substantial" utility, an asserted use must also show that that claimed invention can be used to provide a well-defined and particular benefit to the public.

In 2001, partially in response to questions about the patentability of ESTs, the PTO issued Utility Guidelines governing its internal practice for determining whether a claimed invention satisfies § 101.



See Utility Examination Guidelines, 66 Fed. Reg. 1092 (Jan. 5, 2001). The PTO incorporated these guidelines into the Manual of Patent Examining Procedure ("MPEP"). See U.S. Pat. & Trademark Off., Manual of Patent Examining Procedure § 2107 (8th ed. 2001, rev. May 2004). The MPEP and Guidelines "are not binding on this court, but may be given judicial notice to the extent they do not conflict with the statute." Enzo Biochem v. Gen-Probe, 323 F.3d 956, 964 (Fed. Cir. 2002) (citing Molins PLC v. Textron, Inc., 48 F.3d 1172, 1180 n.10 (Fed. Cir. 1995)). According to the Utility Guidelines, a specific utility is particular to the subject matter claimed and would not be applicable to a broad class of invention. Manual of Patent Examining Procedure § 2107.01. The Utility Guidelines also explain that a substantial utility defines a "real world" use. In particular, "[u]tilities that require or constitute carrying out further research to identify or reasonably confirm a 'real world' context of use are not substantial utilities." Id. Further, the Utility Guidelines discuss "research tools," a term often given to inventions used to conduct research. The PTO particularly cautions that

[a]n assessment that focuses on whether an invention is useful only in a research setting thus does not address whether the invention is in fact "useful" in a patent sense. [The PTO] must distinguish between inventions that have a specifically identified substantial utility and inventions whose asserted utility requires further research to identify or reasonably confirm.

Id. The PTO's standards for assessing whether a claimed invention has a specific and substantial utility comport with this court's interpretation of the utility requirement of § 101.

Turning to the parties' arguments, Fisher first raises a legal issue, charging that the Board applied a heightened standard for utility in the case of ESTs. Fisher apparently bases this argument on statements made by the Board in connection with its discussion of whether the claimed ESTs can be used to identify a polymorphism. In that context, the Board stated:

Somewhere between having no knowledge (the present circumstances) and having complete knowledge of the gene and its role in the plant's development lies the line between 'utility' and 'substantial utility.' We need not draw the line or further define it in this case because the facts in this case represent the lowest end of the spectrum, i.e., an insubstantial use.

Board Decision, slip op. at 15 (emphasis added). Fisher reads the word "spectrum" out of context, claiming that the word somehow implies the application of a higher standard for utility than required by § 101. We conclude, however, that the Board did not apply an incorrect legal standard. In its decision, the Board made reference to a "spectrum" to differentiate between a substantial utility, which satisfies the utility requirement of § 101, and an insubstantial utility, which fails to satisfy § 101. The Board plainly did not announce or apply a new test for assessing the utility of ESTs. It simply followed the Utility Guidelines and MPEP, which mandate the specific and substantial utility test set forth in Brenner. Indeed, we note that Example 9 of the PTO's "Revised Interim Utility Guidelines Training Materials" is applicable to the facts here. See U.S. Pat. & Trademark Off., Revised Interim Utility Guidelines Training Materials 50-53 (1999), available at www.uspto.gov/web/menu/utility.pdf. In that example, a cDNA fragment disclosed as being useful as a probe to obtain the full length gene corresponding to a cDNA fragment was deemed to lack a specific and substantial utility. Additionally, the MPEP particularly explains that a claim directed to a polynucleotide disclosed to be useful as a "gene probe" or "chromosome marker," as is the case here, fails to satisfy the specific utility requirement unless a specific DNA target is also disclosed. Manual of Patent Examining Procedure § 2107.01.

Regarding the seven uses asserted by Fisher, we observe that each claimed EST uniquely corresponds to the single gene from which it was transcribed ("underlying gene"). As of the filing date of the '643 application, Fisher admits that the underlying genes have no known functions. Fisher, nevertheless, claims that this fact is irrelevant because the seven asserted uses are not related to the functions of the underlying genes. We are not convinced by this contention. Essentially, the claimed ESTs act as no more than research intermediates that may help scientists to isolate the particular underlying protein-encoding genes and conduct further experimentation on those genes. The overall goal of such experimentation is presumably to understand the maize genome -- the functions of the underlying genes, the identity of the encoded proteins, the role those proteins play during anthesis, whether


polymorphisms exist, the identity of promoters that trigger protein expression, whether protein expression may be controlled, etc. Accordingly, the claimed ESTs are, in words of the Supreme Court, mere "object[s] of use-testing," to wit, objects upon which scientific research could be performed with no assurance that anything useful will be discovered in the end. Brenner, 383 U.S. at 535.

Fisher compares the claimed ESTs to certain other patentable research tools, such as a microscope. Although this comparison may, on first blush, be appealing in that both a microscope and one of the claimed ESTs can be used to generate scientific data about a sample having unknown properties, Fisher's analogy is flawed. As the government points out, a microscope has the specific benefit of optically magnifying an object to immediately reveal its structure. One of the claimed ESTs, by contrast, can only be used to detect the presence of genetic material having the same structure as the EST itself. It is unable to provide any information about the overall structure let alone the function of the underlying gene. Accordingly, while a microscope can offer an immediate, real world benefit in a variety of applications, the same cannot be said for the claimed ESTs. Fisher's proposed analogy is thus inapt. Hence, we conclude that Fisher's asserted uses are insufficient to meet the standard for a "substantial" utility under § 101.

Moreover, all of Fisher's asserted uses represent merely hypothetical possibilities, objectives which the claimed ESTs, or any EST for that matter, could possibly achieve, but none for which they have been used in the real world. Focusing on the two uses emphasized by Fisher at oral argument, Fisher maintains that the claimed ESTs could be used to identify polymorphisms or to isolate promoters. Nevertheless, in the face of a utility rejection, Fisher has not presented any evidence, as the Board well noted, showing that the claimed ESTs have been used in either way. That is, Fisher does not present either a single polymorphism or a single promoter, assuming at least one of each exists, actually identified by using the claimed ESTs. Further, Fisher has not shown that a polymorphism or promoter so identified would have a "specific and substantial" use. The Board, in fact, correctly recognized this very deficiency and cited it as one of the reasons for upholding the examiner's final rejection.

With respect to the remaining asserted uses, there is no disclosure in the specification showing that any of the claimed ESTs were used as a molecular marker on a map of the maize genome. There also is no disclosure establishing that any of the claimed ESTs were used or, for that matter, could be used to control or provide information about gene expression. Significantly, despite the fact that maize leaves produce over two thousand different proteins during anthesis, Fisher failed to show that one of the claimed ESTs translates into a portion of one of those proteins. Fisher likewise did not provide any evidence showing that the claimed ESTs were used to locate genetic molecules in other plants and organisms. What is more, Fisher has not proffered any evidence showing that any such generic molecules would themselves have a specific and substantial utility. Consequently, because Fisher failed to prove that its claimed ESTs can be successfully used in the seven ways disclosed in the '643 application, we have no choice but to conclude that the claimed ESTs do not have a "substantial" utility under § 101.

Furthermore, Fisher's seven asserted uses are plainly not "specific." Any EST transcribed from any gene in the maize genome has the potential to perform any one of the alleged uses. That is, any EST transcribed from any gene in the maize genome may be a molecular marker or a source for primers. Likewise, any EST transcribed from any gene in the maize genome may be used to measure the level of mRNA in a tissue sample, identify the presence or absence of a polymorphism, isolate promoters, control protein expression, or locate genetic molecules of other plants and organisms. Nothing about Fisher's seven alleged uses set the five claimed ESTs apart from the more than 32,000 ESTs disclosed in the '643 application or indeed from any EST derived from any organism. Accordingly, we conclude that Fisher has only disclosed general uses for its claimed ESTs, not specific ones that satisfy § 101.

We agree with the Board that the facts here are similar to those in Brenner. There, as noted above, the applicant claimed a process for preparing compounds of unknown use. Similarly, Fisher filed an application claiming five particular ESTs which are capable of hybridizing with underlying genes of unknown function found in the maize genome. The Brenner court held that the claimed process lacked a utility because it could be used only to produce a compound of unknown use. The Brenner court stated:


"We find absolutely no warrant for the proposition that although Congress intended that no patent be granted on a chemical compound whose sole 'utility' consists of its potential role as an object of use-testing, a different set of rules was meant to apply to the process which yielded the unpatentable product." 383 U.S. at 535. Applying that same logic here, we conclude that the claimed ESTs, which do not correlate to an underlying gene of known function, fail to meet the standard for utility intended by Congress.

In addition to approving of the Board's reliance on Brenner, we observe that the facts here are even more analogous to those presented in Kirk, 376 F.2d 936, and In re Joly, 376 F.2d 906 (C.C.P.A. 1967), two cases decided by our predecessor court shortly after Brenner. In Kirk, the applicant sought to patent new steroidal compounds disclosed as having two possible utilities. First, the applicant alleged that the claimed compounds were useful for their "biological activity" because "one skilled in the art would know how to use the compounds . . . to take advantage of their presently-existing biological activity." Kirk, 376 F.2d at 939. The court rejected this claimed utility on the ground that it was not sufficiently "specific," but was instead "nebulous." Id. at 941.

Second, the applicant asserted that the claimed compounds could be used by skilled chemists as intermediates in the preparation of final steroidal compounds of unknown use. Relying on Brenner, the court reasoned:

It seems clear that, if a process for producing a product of only conjectural use is not itself "useful" within § 101, it cannot be said that the starting materials for such a process -- i.e., the presently claimed intermediates -- are "useful." It is not enough that the specification disclose that the intermediate exists and that it "works," reacts, or can be used to produce some intended product of no known use. Nor is it enough that the product disclosed to be obtained from the intermediate belongs to some class of compounds which now is, or in the future might be, the subject of research to determine some specific use. Cf. Reiners v. Mehltretter, 236 F.2d 418, 421 [(C.C.P.A. 1956)] where compounds employed as intermediates to produce other directly useful compounds were found to be themselves useful.

Id. at 945-46 (emphasis added). Therefore, the court affirmed the Board's rejection of the claimed compounds for lack of utility.

The facts in Joly are nearly identical to the facts in Kirk. The Joly applicant filed an application claiming compounds useful as intermediates in preparing steroids that were themselves not shown or known to be useful, but that were similar in chemical structure to steroids of known pharmacological usefulness. The court adopted the reasoning of the Kirk court in its entirety and affirmed the Board's decision rejecting the claimed intermediates for failing to comply with § 101. Joly, 376 F.2d at 908-09.

Just as the claimed compounds in Kirk and Joly were useful only as intermediates in the synthesis of other compounds of unknown use, the claimed ESTs can only be used as research intermediates in the identification of underlying protein-encoding genes of unknown function. The rationale of Kirk and Joly thus applies here. In the words of the Kirk court:

We do not believe that it was the intention of the statutes to require the Patent Office, the courts, or the public to play the sort of guessing game that might be involved if an applicant could satisfy the requirements of the statutes by indicating the usefulness of a claimed compound in terms of possible use so general as to be meaningless and then, after his research or that of his competitors has definitely ascertained an actual use for the compound, adducing evidence intended to show that a particular specific use would have been obvious to men skilled in the particular art to which this use relates. 376 F.2d at 942 (emphasis added).

That the Kirk and Joly decisions involved chemical compounds, while the present case involves biological entities, does not distinguish these decisions. The rationale presented therein, having been drawn from principles set forth by the Supreme Court in Brenner, applies with equal force in the fields


of chemistry and biology as well as in any scientific discipline. In Brenner, the Supreme Court was primarily concerned with creating an unwarranted monopoly to the detriment of the public:

Whatever weight is attached to the value of encouraging disclosure and of inhibiting secrecy, we believe a more compelling consideration is that a process patent in the chemical field, which has not been developed and pointed to the degree of specific utility, creates a monopoly of knowledge which should be granted only if clearly commanded by the statute. Until the process claim has been reduced to production of a product shown to be useful, the metes and bounds of that monopoly are not capable of precise delineation. It may engross a vast, unknown, and perhaps unknowable area. Such a patent may confer power to block off whole areas of scientific development, without compensating benefit to the public. . . . This is not to say that we mean to disparage the importance of contributions to the fund of scientific information short of the invention of something "useful," or that we are blind to the prospect that what now seems without "use" may tomorrow command the grateful attention of the public. But a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion. [A] patent system must be related to the world of commerce rather than to the realm of philosophy.

Brenner, 383 U.S. at 535-36 (citations, quotation, and footnote omitted). Here, granting a patent to Fisher for its five claimed ESTs would amount to a hunting license because the claimed ESTs can be used only to gain further information about the underlying genes and the proteins encoded for by those genes. The claimed ESTs themselves are not an end of Fisher's research effort, but only tools to be used along the way in the search for a practical utility. Thus, while Fisher's claimed ESTs may add a noteworthy contribution to biotechnology research, our precedent dictates that the '643 application does not meet the utility requirement of § 101 because Fisher does not identify the function for the underlying protein-encoding genes. Absent such identification, we hold that the claimed ESTs have not been researched and understood to the point of providing an immediate, well-defined, real world benefit to the public meriting the grant of a patent.

2.

Fisher's reliance on Jolles, Nelson, and Cross, cases which found utility in certain claimed pharmaceutical compounds, is misplaced. In Jolles, the applicant filed an application claiming naphthacene compounds useful in treating acute myloblastic leukemia. To support the asserted utility, the applicant presented in vivo data showing eight of the claimed compounds effectively treated tumors in a mouse model. Our predecessor court reversed the Board's affirmance of the final rejection for lack of utility, finding that the structural similarity between the compounds tested in vivo and the remaining claimed compounds was sufficient to establish utility for the remaining claimed compounds. Jolles, 628 F.2d at 1327-28.

In Nelson, decided by the Court of Customs and Patent Appeals in the same year as Jolles, Nelson claimed prostaglandin compounds. The PTO declared an interference with an application filed by Bowler claiming the same compounds. The issue before the Board was whether Nelson had established utility for the claimed prostaglandins as smooth muscle stimulants and blood pressure modulators via in vivo and in vitro data, specifically, an in vivo rat blood pressure test and an in vitro gerbil colon smooth muscle stimulation test. The Board declined to award priority to Nelson, characterizing Nelson's tests as "rough screens, uncorrelated with actual utility [in humans]." Our predecessor court reversed, concluding that "tests evidencing pharmacological activity may manifest a practical utility even though they may not establish a specific therapeutic use." Nelson, 626 F.2d at 856.

In Cross, decided by the Federal Circuit five years after Jolles and Nelson, Iizuka filed an application claiming thromboxane synthetase inhibitors, alleged to be useful in treating inflammation, asthma, hypertension, and other ailments. When Cross filed an application claiming the same compounds two months after Iizuka, the PTO declared an interference. The dispositive issue concerned whether Iizuka's Japanese priority application disclosed utility for the claimed inhibitors. The Board concluded that it offered a sufficient disclosure based upon in vitro data showing strong inhibitory action for thromboxane


synthetase for structurally-similar compounds in human or bovine platelet microsomes. We affirmed, reasoning:

Opinions of our predecessor court have recognized the fact that pharmacological testing of animals is a screening procedure for testing new drugs for practical utility. This in vivo testing is but an intermediate link in a screening chain which may eventually lead to the use of the drug as a therapeutic agent in humans. We perceive no insurmountable difficulty, under appropriate circumstances, in finding that the first link in the screening chain, in vitro testing, may establish a practical utility for the compound in question. Successful in vitro testing will marshal resources and direct the expenditure of effort to further in vivo testing of the most potent compounds, thereby providing an immediate benefit to the public, analogous to the benefit provided by the showing of an in vivo utility. Cross, 753 F.2d at 1050 (citations omitted).

The facts in these three cases are readily distinguishable from the facts here. In Jolles, Nelson, and Cross, the applicants disclosed specific pharmaceutical uses in humans for the claimed compounds and supported those uses with specific animal test data, in vitro, in vivo, or both. In contrast, Fisher disclosed a variety of asserted uses for the claimed ESTs, but failed to present any evidence -- test data, declaration, deposition testimony, or otherwise -- to support those uses as presently beneficial and hence practical. Fisher did not show that even one of the claimed ESTs had been tested and successfully aided in identifying a polymorphism in the maize genome or in isolating a single promoter that could give clues about protein expression. Adopting the language of the Cross court, the alleged uses in Jolles, Nelson, and Cross were not "nebulous expressions, such as 'biological activity' or 'biological properties' [alleged in the application in Kirk]," that "convey little explicit indication regarding the utility of a compound." Cross, 753 F.2d at 1048. Instead, the alleged uses in those cases gave a firm indication of the precise uses to which the claimed compounds could be put. For example, in Nelson, the claimed prostaglandins could be used to stimulate smooth muscle or modulate blood pressure in humans as shown by both in vivo and in vitro animal data. Hence, the Jolles, Nelson, and Cross courts concluded that the claimed pharmaceutical compounds satisfied the specific and substantial utility requirements of § 101. We cannot reach that same conclusion here. Fisher's laundry list of uses, like the terms "biological activity" or "biological properties" alleged in Kirk, are nebulous, especially in the absence of any data demonstrating that the claimed ESTs were actually put to the alleged uses.

Fisher's reliance on the commercial success of general EST databases is also misplaced because such general reliance does not relate to the ESTs at issue in this case. Fisher did not present any evidence showing that agricultural companies have purchased or even expressed any interest in the claimed ESTs. And, it is entirely unclear from the record whether such business entities ever will. Accordingly, while commercial success may support the utility of an invention, it does not do so in this case. See Raytheon Co. v. Roper Corp., 724 F.2d 951, 959 (Fed. Cir. 1983) (stating that proof of a utility may be supported when a claimed invention meets with commercial success).

3.

As a final matter, we observe that the government and its amici express concern that allowing EST patents without proof of utility would discourage research, delay scientific discovery, and thwart progress in the "useful Arts" and "Science." See U.S. Const. art. I, § 8, cl. 8. The government and its amici point out that allowing EST claims like Fisher's would give rise to multiple patents, likely owned by several different companies, relating to the same underlying gene and expressed protein. Such a situation, the government and amici predict, would result in an unnecessarily convoluted licensing environment for those interested in researching that gene and/or protein.

The concerns of the government and amici, which may or may not be valid, are not ones that should be considered in deciding whether the application for the claimed ESTs meets the utility requirement of § 101. The same may be said for the resource and managerial problems that the PTO potentially would face if applicants present the PTO with an onslaught of patent applications directed to particular ESTs. Congress did not intend for these practical implications to affect the determination of whether an


invention satisfies the requirements set forth in 35 U.S.C. §§ 101, 102, 103, and 112. They are public policy considerations which are more appropriately directed to Congress as the legislative branch of government, rather than this court as a judicial body responsible simply for interpreting and applying statutory law. Under Title 35, an applicant is entitled to a patent if his invention is new, useful, nonobvious, and his application adequately describes the claimed invention, teaches others how to make and use the claimed invention, and discloses the best mode for practicing the claimed invention. What is more, when Congress enacted § 101, it indicated that "anything under the sun that is made by man" constitutes potential subject matter for a patent.

S. Rep. No. 82-1979, at 7 (1985). Policy reasons aside, because we conclude that the utility requirement of § 101 is not met, we hold that Fisher is not entitled to a patent for the five claimed ESTs.

B. Enablement

Fisher asserts that we should reverse the enablement rejection upheld by the Board since the Board made it contingent upon the utility rejection, which Fisher argues was not supported by substantial evidence for reasons analyzed above. The government argues to the contrary, asserting that claim 1 of the '643 application cannot be enabled because the claimed ESTs were not disclosed as having a specific and substantial utility. We agree with the government. It is well established that the enablement requirement of § 112 incorporates the utility requirement of § 101.

The how to use prong of section 112 incorporates as a matter of law the requirement of 35 U.S.C. § 101 that the specification disclose as a matter of fact a practical utility for the invention. If the application fails as a matter of fact to satisfy 35 U.S.C. § 101, then the application also fails as a matter of law to enable one of ordinary skill in the art to use the invention under 35 U.S.C. § 112.

Ziegler, 992 F.2d at 1200-01 (citations omitted); see also Kirk, 376 F.2d at 942 ("Necessarily, compliance with § 112 requires a description of how to use presently useful inventions, otherwise an applicant would anomalously be required to teach how to use a useless invention."); In re Brana, 51 F.3d 1560, 1564 (Fed. Cir. 1995) ("Obviously, if a claimed invention does not have utility, the specification cannot enable one to use it."); Manual of Patent Examining Procedure § 2107.01. Here, in light of our conclusion that the Board's decision with respect to utility applied the correct legal standard and was supported by substantial evidence, we conclude that Fisher failed to satisfy the enablement requirement. Consequently, we leave undisturbed the enablement rejection of the '643 application under § 112, first paragraph.

III. CONCLUSION

We conclude that substantial evidence supports the Board's findings that each of the five claimed ESTs lacksa specific and substantial utility and that they are not enabled. Accordingly, the Board's decision affirming the final rejection of claim 1 of the '643 patent for lack of utility under § 101 and lack of enablement under § 112, first paragraph, is affirmed.

AFFIRMED

RADER, Circuit Judge, dissenting.

This court today determines that expressed sequence tags (ESTs) do not satisfy 35 U.S.C. § 101 unless there is a known use for the genes from which each EST is transcribed. While I agree that an invention must demonstrate utility to satisfy § 101, these claimed ESTs have such a utility, at least as research tools in isolating and studying other molecules. Therefore, I respectfully dissent.

Several, if not all, of Fisher's asserted utilities claim that ESTs function to study other molecules. In simple terms, ESTs are research tools. Admittedly ESTs have use only in a research setting. However,


the value and utility of research tools generally is beyond question, even though limited to a laboratory setting. See U.S. Pat. & Trademark Off., Manual of Patent Examining Procedure (MPEP) § 2107.01 at 2100-33 (8th ed. 2001, rev. Feb. 2003) ("Many research tools such as gas chromatographs, screening assays, and nucleotide sequencing techniques have a clear, specific and unquestionable utility (e.g., they are useful in analyzing compounds)."). Thus, if the claimed ESTs qualify as research tools, then they have a "specific" and "substantial" utility sufficient for § 101. If these ESTs do not enhance research, then Brenner v. Manson, 383 U.S. 519 (1966) (involving the patentability of methods for producing compounds having no known use) controls and erects a § 101 bar for lack of utility. For the following reasons, these claimed ESTs are more akin to patentable research tools than to the unpatentable methods in Brenner.

In Brenner, the Court confronted a growing conflict between this court's predecessor, the Court of Customs and Patent Appeals (CCPA), and the Patent Office over the patentability of methods of producing compounds with no known use. This conflict began with In re Nelson, 280 F.2d 172 (CCPA 1960), the first in a series of cases wherein the CCPA reversed several Patent Office utility rejections. Brenner, 383 U.S. at 530. Brenner put an end to these cases because, in the 1960s, the Court could not distinguish between denying patents to compounds with no known use and denying patents to methods of producing those useless compounds. The Court commented:

We find absolutely no warrant for the proposition that although Congress intended that no patent be granted on a chemical compound whose sole 'utility' consists of its potential role as an object of use-testing, a different set of rules was meant to apply to the process which yielded the unpatentable product. That proposition seems to us little more than an attempt to evade the impact of the rules which concededly govern patentability of the product itself.

Id. at 535. This court's predecessor later extended Brenner to bar patents on compounds as intermediates in the preparation of other compounds having no known use. See In re Kirk, 376 F.2d 936 (CCPA 1967) (rejecting intermediaries for steroids with no known use). These cases, however, share a common underpinning - a method of producing a compound with no known use has no more benefit to society than the useless compound itself.

This case is very different. Unlike the methods and compounds in Brenner and Kirk, Fisher's claimed EST's are beneficial to society. As an example, these research tools "may help scientists to isolate the particular underlying protein-encoding genes . . . [with the] overall goal of such experimentation . . . presumably [being] to understand the maize genome[.]" Majority Opinion, slip op. at 13. They also can serve as a probe introduced into a sample tissue to confirm "that the gene corresponding to the EST was being expressed in the sample tissue at the time of mRNA extraction." Id., slip op. at 3.

These research tools are similar to a microscope; both take a researcher one step closer to identifying and understanding a previously unknown and invisible structure. Both supply information about a molecular structure. Both advance research and bring scientists closer to unlocking the secrets of the corn genome to provide better food production for the hungry world. If a microscope has § 101 utility, so too do these ESTs.

The Board and this court acknowledge that the ESTs perform a function, that they have a utility, but proceed quickly to a value judgment that the utility would not produce enough valuable information. The Board instead complains that the information these ESTs supply is too "insubstantial" to merit protection. Yet this conclusion denies the very nature of scientific advance. Science always advances in small incremental steps. While acknowledging the patentability of research tools generally (and microscopes as one example thereof), this court concludes with little scientific foundation that these ESTs do not qualify as research tools because they do not "offer an immediate, real world benefit" because further research is required to understand the underlying gene. This court further faults the EST research for lacking any "assurance that anything useful will be discovered in the end." These criticisms would foreclose much scientific research and many vital research tools. Often scientists embark on research with no assurance of success and knowing that even success will demand "significant additional research."


Nonetheless, this court, oblivious to the challenges of complex research, discounts these ESTs because it concludes (without scientific evidence) that they do not supply enough information. This court reasons that a research tool has a "specific" and "substantial" utility only if the studied object is readily understandable using the claimed tool - that no further research is required. Surely this cannot be the law. Otherwise, only the final step of a lengthy incremental research inquiry gets protection.

Even with a microscope, significant additional research is often required to ascertain the particular function of a "revealed" structure. To illustrate, a cancerous growth, magnified with a patented microscope, can be identified and distinguished from other healthy cells by a properly trained doctor or researcher. But even today, the scientific community still does not fully grasp the reasons that cancerous growths increase in mass and spread throughout the body,*fn5 or the nature of compounds that interact with them, or the interactions of environmental or genetic conditions that contribute to developing cancer. Significant additional research is required to answer these questions. Even with answers to these questions, the cure for cancer will remain in the distance. Yet the microscope still has "utility" under § 101. Why? Because it takes the researcher one step closer to answering these questions. Each step, even if small in isolation, is nonetheless a benefit to society sufficient to give a viable research tool "utility" under § 101. In fact, experiments that fail still serve to eliminate some possibilities and provide information to the research process.

The United States Patent Office, above all, should recognize the incremental nature of scientific endeavor. Yet, in the interest of easing its administrative load, the Patent Office will eliminate some research tools as providing "insubstantial" advances. How does the Patent Office know which "insubstantial" research step will contribute to a substantial breakthrough in genomic study? Quite simply, it does not.

In addition, this court faults Fisher for not presenting evidence of utility showing that the claimed ESTs "have been used in the real world." To the contrary, this court misapprehended the proper procedure. Fisher asserted seven different utilities. The Board rejected two of these assertions outright as "insubstantial." See Ex parte Fisher, App. No. 2002-2046, slip. op at 14-16 (Bd. Pat. App. and Int. 2004) (acknowledging that the ESTs may be able to detect "the absence of a polymorphism" and "to isolate nucleic acid molecules of other plants and organisms[,]" but finding such utilities are not "substantial" even if the ESTs can perform them). This summary dismissal deprived Fisher of any chance to proffer evidence. Rather than fault Fisher for not presenting evidence it was prevented from offering, this court should instead observe that the Board did not satisfy its burden of challenging Fisher's presumptively correct assertion that the ESTs were capable of performing those functions. See MPEP § 2107.02(IV) at 2100-40 (noting that the initial burden is on the office to establish a prima facie case as to lack of utility and to provide evidentiary support thereof); In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995) (where an applicant has asserted utility in the disclosure, the Patent Office has the initial burden of challenging this presumptively correct assertion of utility).

Abandoning the proper legal procedure, the Board reasoned that the molecules studied with these ESTs showed no particular use, therefore the ESTs themselves also lacked a utility. In so ruling, the Board did not reject Fisher's utilities on the basis that the ESTs were unable to perform the purported utilities. Thus, the Board did not establish a prima facie challenge to the ESTs' ability to perform these two utilities. Without anything to rebut, Fisher had no obligation or opportunity to provide evidence in rebuttal. Thus, I respectfully disagree with this court's conclusion that the Board's decision can be affirmed on the basis that Fisher did not supply evidence of the ESTs' ability to perform the asserted utilities.

In truth, I have some sympathy with the Patent Office's dilemma. The Office needs some tool to reject inventions that may advance the "useful arts" but not sufficiently to warrant the valuable exclusive right of a patent. The Patent Office has seized upon this utility requirement to reject these research tools as contributing "insubstantially" to the advance of the useful arts. The utility requirement is ill suited to that task, however, because it lacks any standard for assessing the state of the prior art and the contributions of the claimed advance. The proper tool for assessing sufficient contribution to the useful arts is the obviousness requirement of 35 U.S.C. § 103. Unfortunately this court has deprived the



Patent Office of the obviousness requirement for genomic inventions. See In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995); Martin J. Adelman et al., Patent Law, 517 (West Group 1998) (commenting that scholars have been critical of Deuel, which "overly favored patent applicants in biotech by adopting an overly lax nonobviousness standard." (citing Anita Varma & David Abraham, DNA Is Different: Legal Obviousness and the Balance Between Biotech Inventors and the Market, 9 Harv. J. L. & Tech. 53 (1996)));Philippe Ducor, The Federal Circuit and In re Deuel: Does §103 apply to Naturally Occurring DNA?, 77 J. Pat. & Trademark Off. Soc'y 871, 883 (Nov. 1995) ("The Court of Appeals for the Federal Circuit could have formulated its opinion in only one sentence: '35 U.S.C. § 103 does not apply to newly retrieved natural DNA sequences.'"); Philippe Ducor,Recombinant Products and Nonobviousness: A Typology, 13 Santa Clara Computer and High Tech. L.J. 1, 44-45 (Feb. 1997) ("This amounts to a practical elimination of the requirement for nonobviousnessfor these products, even when all the information necessary to discover them is previously available."); see also over fifty additional articles critical of Deuel in the "Citing References" tab for Deuel on Westlaw. Nonetheless, rather than distort the utility test, the Patent Office should seek ways to apply the correct test, the test used world wide for such assessments (other than in the United States), namely inventive step or obviousness.

Thus, for the foregoing reasons, I would find that Fisher's asserted utilities qualify the claimed ESTs as research tools useful in the study of other molecules. Because research tools provide a cognizable benefit to society, much like a microscope, the ESTs claimed here have "utility" under § 101. In addition, the enablement rejection should also be reversed because it was a consequence of the finding of lack of utility.


5. DISCLOSURE AND ENABLEMENT ART. 29, TRIPS Agreement Conditions on Patent Applicants

1. Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application.

2. Members may require an applicant for a patent to provide information concerning the applicant’s corresponding foreign applications and grants

SEC. 35, IP Code SEC. 35. Disclosure and Description of the Invention. – 35.1. Disclosure. – The application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. Where the application concerns a microbiological process or the product thereof and involves the use of a micro-organism which cannot be sufficiently disclosed in the application in such a way as to enable the invention to be carried out by a person skilled in the art, and such material is not available to the public, the application shall be supplemented by a deposit of such material with an international depository institution. 35.2. Description. – The Regulations shall prescribe the contents of the description and the order of presentation. (Sec. 14, R.A. No. 165a)

a. Undue Experimentation • case: The Incandescent Lamp Patent

U.S. Supreme Court

The Incandescent Lamp Patent, 159 U.S. 465 (1895)

The Incandescent Lamp Patent

No. 10

Argued October 29-30, 1894

Decided November 11, 1895

159 U.S. 465

Syllabus

With the exception of the third claim, viz., for "the incandescing conductor for an electric lamp, formed of carbonized paper, substantially as described," the claims in the letters patent No. 317,076, issued May 12, 1880, to the Electro-Dynamic Light Company, assignee of Sawyer and Man, for an electric light, are too indefinite to be the subject of a valid monopoly.

This was a bill in equity, filed by the Consolidated Electric Light Company against the McKeesport Light Company, to recover damages for the infringement of letters patent No. 317,076, issued May 12, 1885, to


the Electro-Dynamic Light Company, assignee of Sawyer and Man, for an electric light. The defendants justified under certain patents to Thomas A. Edison, particularly No. 223,898, issued January 27, 1880; denied the novelty and utility of the complainant's patent, and averred that the same had been fraudulently and illegally procured. The real defendant was the Edison Electric Light Company, and the case involved a contest between what are known as the Sawyer and Man and the Edison systems of electric lighting.

In their application, Sawyer and Man stated that their invention related to

"that class of electric lamps employing an incandescent conductor enclosed in a transparent, hermetically sealed vessel or chamber from which oxygen is excluded, and . . . more especially to the incandescing conductor, its substance, its form, and its combination with the other elements composing the lamp. Its object is to secure a cheap and effective apparatus, and our improvement consists first, of the combination, in a lamp chamber composed wholly of glass, as described in patent No. 205, 144,"

upon which this patent was declared to be an improvement,

"of an incandescing conductor of carbon made from a vegetable fibrous material, in contradistinction to a similar conductor made from mineral or gas carbon, and also in the form of such conductor so made from such vegetable carbon, and combined in the lighting circuit with the exhausted chamber of the lamp."

The following drawings exhibit the substance of the invention:

Image a:

The specification further stated that:

"In the practice of our invention, we have made use of carbonized paper, and also wood carbon. We have also used such conductors or burners of various shapes, such as pieces with their lower ends secured to their respective supports, and having their upper ends united so as to form an inverted V-shaped burner. We have also used conductors of varying contours -- that is, with rectangular bends instead of curvilinear ones; but we prefer the arch shape."

"No especial description of making the illuminating carbon conductors, described in this specification, and making the subject matter of this improvement, is thought necessary, as any of the ordinary methods of forming the material to be carbonized to the desired shape and size, and carbonizing it while confined in retorts in powdered carbon, substantially according to the methods in practice before the date of this improvement, may be adopted in the practice thereof by anyone skilled in the arts appertaining to the making of carbons for electric lighting or for other use in the arts."

"An important practical advantage which is secured by the arch form of incandescing carbon is that it permits the carbon to expand and contract under the varying temperatures to which it is subjected when the electric current is turned on or off without altering the position of its fixed terminals. Thus, the necessity for a special mechanical device to compensate for the expansion and contraction which has heretofore been necessary is entirely dispensed with, and thus the lamp is materially simplified in its construction. Another advantage of the arch form is that the shadow cast by such burners is less than that produced by other forms of burners when fitted with the necessary devices to support them."

"Another important advantage resulting from our construction of the lamp results from the fact that the wall forming the chamber of the lamp through which the electrodes pass to the interior of the lamp is made wholly of glass, by which all danger of oxidation, leakage, or short-circuiting is avoided."


"The advantages resulting from the manufacture of the carbon from vegetable fibrous or textile material instead of mineral or gas carbon are many. Among them may be mentioned the convenience afforded for cutting and making the conductor in the desired form and size, the purity and equality of the carbon obtained, its susceptibility to tempering, both as to hardness and resistance, and its toughness and durability. We have used such burners in closed or hermetically sealed transparent chambers, in a vacuum, in nitrogen gas, and in hydrogen gas; but we have obtained the best results in a vacuum or an attenuated atmosphere of nitrogen gas, the great desideratum being to exclude oxygen or other gases capable of combining with carbon at high temperatures from the incandescing chamber, as is well understood."

The claims were as follows:

"1. An incandescing conductor for an electric lamp, of carbonized fibrous or textile material, and of an arch or horseshoe shape, substantially as hereinbefore set forth."

"2. The combination, substantially as hereinbefore set forth, of an electric circuit and an incandescing conductor of carbonized fibrous material, included in and forming part of said circuit, and a transparent, hermetically sealed chamber, in which the conductor is enclosed."

"3. The incandescing conductor for an electric lamp, formed of carbonized paper, substantially as described."

"4. An incandescing electric lamp consists of the following elements in combination: first, an illuminating chamber made wholly of glass hermetically sealed and out of which all carbon-consuming gas has been exhausted or driven; second, an electric circuit conductor passing through the glass wall of said chamber and hermetically sealed therein, as described; third, an illuminating conductor in said circuit and forming part thereof within said chamber, consisting of carbon made from a fibrous or textile material having the form of an arch or loop, substantially as described, for the purpose specified."

The commercial Edison lamp used by the appellee, and which is illustrated below, is composed of a burner, A, made of carbonized bamboo of a peculiar quality, discovered by Mr. Edison to be highly useful for the purpose, and having a length of about six inches, a diameter of about five one-thousandths of an inch, and an electrical resistance of upward of 100 ohms. This filament of carbon is bent into the form of a loop, and its ends are secured by good electrical and mechanical connections to two fine platinum wires, B, B. These wires pass through a glass stem, C, the glass being melted and fused upon the platinum wires. A glass globe, D, is fused to the glass stem, C. This glass globe has originally attached to it at the point d a glass tube by means of which a connection is made with highly organized and refined exhausting apparatus, which produces in the globe a high vacuum, whereupon the glass tube is melted off by a flame, and the globe is closed by the fusion of the glass at the point d.

Image b:

Upon a hearing in the circuit court before Mr. Justice Bradley upon pleadings and proofs, the court held the patent to be invalid and dismissed the bill. 40 F. 21. Thereupon complainant appealed to this Court.

MR. JUSTICE BROWN, after stating the facts in the foregoing language, delivered the opinion of the Court.


In order to obtain a complete understanding of the scope of the Sawyer and Man patent, it is desirable to consider briefly the state of the art at the time the application was originally made, which was in January, 1880.

Two general forms of electric illumination had for many years been the subject of experiments more or less successful, one of which was known as the "arc light," produced by the passage of a current of electricity between the points of two carbon pencils placed end to end, and slightly separated from each other. In its passage from one point to the other through the air, the electric current took the form of an arc, and gave the name to the light. This form of light had been produced by Sir Humphry Davy as early as 1810, and, by successive improvements in the carbon pencils and in their relative adjustment to each other, had come into general use as a means of lighting streets, halls, and other large spaces; but by reason of its intensity, the uncertain and flickering character of the light, and the rapid consumption of the carbon pencils, it was wholly unfitted for domestic use. The second form of illumination is what is known as the "incandescent system," and consists generally in the passage of a current of electricity through a continuous strip or piece of refractory material, which is a conductor of electricity, but a poor conductor -- in other words, a conductor offering a considerable resistance to the flow of the current through it. It was discovered early in this century that various substances might be heated to a white heat by passing a sufficiently strong current of electricity through them. The production of a light in this way does not in any manner depend upon the consumption or wearing away of the conductor, as it does in the arc light. The third system was a combination of the two others, but it never seems to have come into general use, and is unimportant in giving a history of the art.

For many years prior to 1880, experiments had been made by a large number of persons in various countries with a view to the production of an incandescent light which could be made available for domestic purposes and could compete with gas in the matter of expense. Owing party to a failure to find a proper material, which should burn but not consume, partly to the difficulty of obtaining a perfect vacuum in the globe in which the light was suspended, and partly to a misapprehension of the true principle of incandescent lighting, these experiments had not been attended with success, although it had been demonstrated as early as 1845 that, whatever material was used, the conductor must be enclosed in an air-tight bulb to prevent it from being consumed by the oxygen in the atmosphere. The chief difficulty was that the carbon burners were subject to a rapid disintegration or evaporation, which electricians assumed was due to the disrupting action of the electric current, and hence the conclusion was reached that carbon contained in itself the elements of its own destruction, and was not a suitable material for the burner of an incandescent lamp.

It is admitted that the lamp described in the Sawyer and Man patent is no longer in use, and was never a commercial success; that it does not embody the principle of high resistance with a small illuminating surface; that it does not have the filament burner of the modern incandescent lamp; that the lamp chamber is defective, and that the lamp manufactured by the complainant, and put upon the market, is substantially the Edison lamp; but it is said that in the conductor used by Edison (a particular part of the stem of the bamboo, lying directly beneath the siliceous cuticle, the peculiar fitness for which purpose was undoubtedly discovered by him), he made use of a fibrous or textile material covered by the patent to Sawyer and Man, and is therefore an infringer. It was admitted, however, that the third claim -- for a conductor of carbonized paper -- was not infringed.

The two main defenses to this patent are (1) that it is defective upon its face in attempting to monopolize the use of all flbrous and textile materials for the purpose of electric illuminations, and (2) that Sawyer and Man were not in fact the first to discover that these were better adapted than mineral carbons to such purposes.


Is the complainant entitled to a monopoly of all fibrous and textile materials for incandescent conductors? If the patentees had discovered in fibrous and textile substances a quality common to them all, or to them generally, as distinguishing them from other materials such as minerals, etc., and such quality or characteristic adapted them peculiarly to incandescent conductors, such claim might not be too broad. If, for instance, minerals or porcelains had always been used for a particular purpose, and a person should take out a patent for a similar article of wood, and woods generally were adapted to that purpose, the claim might not be too broad, though defendant used wood of a different kind from that of the patentee. But if woods generally were not adapted to the purpose, and yet the patentee had discovered a wood possessing certain qualities which gave it a peculiar fitness for such purpose, it would not constitute an infringement for another to discover and use a different kind of wood which was found to contain similar or superior qualities. The present case is an apt illustration of this principle. Sawyer and Man supposed they had discovered in carbonized paper the best material for an incandescent conductor. Instead of confining themselves to carbonized paper, as they might properly have done, and in fact did in their third claim, they made a broad claim for every fibrous or textile material, when in fact an examination of over 6,000 vegetable growths showed that none of them possessed the peculiar qualities that fitted them for that purpose. Was everybody, then, precluded by this broad claim from making further investigation? We think not.

The injustice of so holding is manifest in view of the experiments made and continued for several months by Mr. Edison and his assistants among the different species of vegetable growth for the purpose of ascertaining the one best adapted to an incandescent conductor. Of these he found suitable for his purpose only about three species of bamboo, one species of cane from the valley of the Amazon (impossible to be procured in quantities on account of the climate), and one or two species of fibers from the agave family. Of the special bamboo, the walls of which have a thickness of about 3/8 of an inch, he used only about 20/1000 of an inch in thickness. In this portion of the bamboo, the fibers are more nearly parallel, the cell walls are apparently smallest, and the pithy matter between the fibers is at its minimum. It seems that carbon filaments cannot be made of wood -- that is, exogenous vegetable growth -- because the fibers are not parallel, and the longitudinal fibers are intercepted by radial fibers. The cells composing the fibers are all so large that the resulting carbon is very porous and friable. Lamps made of this material proved of no commercial value. After trying as many as thirty or forty different woods of exogenous growth, he gave them up as hopeless. But finally, while experimenting with a bamboo strip which formed the edge of a palm leaf fan, cut into filaments, he obtained surprising results. After microscopic examination of the material, he dispatched a man to Japan to make arrangements for securing the bamboo in quantities. It seems that the characteristic of the bamboo which makes it particularly suitable is that the fibers run more nearly parallel than in other species of wood. Owing to this, it can be cut up into filaments having parallel fibers, running throughout their length, and producing a homogeneous carbon. There is no generic quality, however, in vegetable fibers, because they are fibrous, which adapts them to the purpose. Indeed, the fibers are rather a disadvantage. If the bamboo grew solid, without fibers, but had its peculiar cellular formation, it would be a perfect material, and incandescent lamps would last at least six times as long as at present. All vegetable fibrous growths do not have a suitable cellular structure. In some, the cells are so large that they are valueless for that purpose. No exogenous, and very few endogenous, growths are suitable. The messenger whom he dispatched to different parts of Japan and China sent him about forty different kinds of bamboo in such quantities as to enable him to make a number of lamps, and from a test of these different species he ascertained which was best for the purpose. From this it appears very clearly that there is no such quality common to fibrous and textile substances generally as makes them suitable for an incandescent conductor, and that the bamboo which was finally pitched upon, and is now generally used, was not selected because it was of vegetable growth, but because it contained certain peculiarities in its fibrous structure which distinguished it from every other fibrous substance. The question really is whether the imperfectly successful experiments of Sawyer


and Man, with carbonized paper and wood carbon, conceding all that is claimed for them, authorize them to put under tribute the results of the brilliant discoveries made by others.

It is required by Rev.Stat. § 4888 that the application shall contain

"a written description of the device, and of the manner and process of making constructing, compounding, and using it in such full, clear, concise, and exact terms as to enable any person skilled in the art or science to which it appertains or with which it is most nearly connected to make, construct, compound, and use the same."

The object of this is to apprise the public of what the patentee claims as his own, the courts of what they are called upon to construe, and competing manufacturers and dealers of exactly what they are bound to avoid. Grant v. Raymond, 6 Pet. 218, 31 U. S. 247. If the description be so vague and uncertain that no one can tell, except by independent experiments, how to construct the patented device, the patent is void.

It was said by Mr. Chief Justice Taney, in Wood v. Underhill, 5 How. 1, 46 U. S. 5, with respect to a patented compound for the purpose of making brick or tile, which did not give the relative proportions of the different ingredients:

"But when the specification of a new composition of matter gives only the names of the substances which are to be mixed together, without stating any relative proportion, undoubtedly it would be the duty of the court to declare the patent void. And the same rule would prevail where it was apparent that the proportions were stated ambiguously and vaguely, for in such cases it would be evident on the face of the specification that no one could use the invention without first ascertaining by experiment the exact proportion of the different ingredients required to produce the result intended to be obtained. . . . And if, from the nature and character of the ingredients to be used, they are not susceptible of such exact description, the inventor is not entitled to a patent."

So in Tyler v. Boston, 7 Wall. 327, wherein the plaintiff professed to have discovered a combination of fusel oil with the mineral and earthy oils, constituting a burning fluid, the patentee stated that the exact quantity of fusel oil which is necessary to produce the most desirable compount must be determined by experiment. And the Court observed:

"Where a patent is claimed for such a discovery, it should state the component parts of the new manufacture claimed with clearness and precision, and not leave a person attempting to use the discovery to find it out 'by experiment.'"

Applying this principle to the patent under consideration, how would it be possible for a person to know what fibrous or textile material was adapted to the purpose of an incandescent conductor except by the most careful and painstaking experimentation? If, as before observed, there were some general quality, running through the whole fibrous and textile kingdom, which distinguished it from every other, and gave it a peculiar fitness for the particular purpose, the man who discovered such quality might justly be entitled to a patent; but that is not the case here. An examination of materials of this class carried on for months revealed nothing that seemed to be adapted to the purpose, and even the carbonized paper and wood carbons specified in the patent, experiments with which first suggested their incorporation therein, were found to be so inferior to the bamboo, afterwards discovered by Edison, that the complainant was forced to abandon its patent in that particular and take up with the material discovered by its rival. Under these circumstances, to hold that one who had discovered that a certain fibrous or textile material answered the required purpose should obtain the right to exclude everybody from the whole domain of fibrous and textile materials, and thereby shut out any further efforts to discover a better specimen of that class than the patentee had employed, would be an unwarranted extension of his monopoly and operate rather to discourage than to promote invention. If Sawyer and Man had discovered that a certain


carbonized paper would answer the purpose, their claim to all carbonized paper would perhaps not be extravagant, but the fact that paper happens to belong to the fibrous kingdom did not invest them with sovereignty over this entire kingdom and thereby practically limit other experimenters to the domain of minerals.

In fact, such a construction of this patent as would exclude competitors from making use of any fibrous or textile material would probably defeat itself, since, if the patent were infringed by the use of any such material, it would be anticipated by proof of the prior use of any such material. In this connection, it would appear not only that wood charcoal had been constantly used since the days of Sir Humphry Davy for arc lighting, but that, in the English patent to Greener and Staite, of 1846, for an incandescent light, "charcoal, reduced to a state of powder," was one of the materials employed. So also, in the English patent of 1841 to De Moleyns, "a finely pulverized boxwood charcoal or plumbago" was used for an incandescent electric lamp. Indeed, in the experiments of Sir Humphry Davy early in the century, pieces of well burned charcoal were heated to a vivid whiteness by the electric current, and other experiments were made which evidently contemplated the use of charcoal heated to the point of incandescence. Mr. Broadnax, the attorney who prepared the application, it seems, was also of opinion that a broad claim for vegetable carbons could not be sustained, because charcoal had been used before in incandescent lighting. There is undoubtedly a good deal of testimony tending to show that for the past fifty or sixty years, the word "charcoal" has been used in the art not only to designate carbonized wood, but mineral or hard carbons, such as were commonly employed for the carbon pencils of arc lamps. But we think it quite evident that in the patents and experiments above referred to it was used in its ordinary sense of charcoal obtained from wood. The very fact of the use of such word to designate mineral carbons indicates that such carbons were believed to possess peculiar properties required for illumination that before that had been supposed to belong to wood charcoal.

We have not found it necessary in this connection to consider the amendments that were made to the original specification, upon which so much stress was laid in the opinion of the court below, since we are all agreed that the claims of this patent, with the exception of the third, are too indefinite to be the subject of a valid monopoly.

As these suggestions are of themselves sufficient to dispose of the case adversely to the complainant, a consideration of the question of priority of invention, or rather of the extent and results of the Sawyer and Man experiments, which was so fully argued upon both sides and passed upon by the court below, becomes unnecessary.

For the reasons above stated, the decree of the circuit court is

Affirmed.


• case: In re Wands

UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT Decided: September 30, 1988; As Amended October 20, 1988.

IN RE JACK R. WANDS, VINCENT R. ZURAWSKI, JR., AND HUBERT J. P. SCHOEMAKER

Appealed from: Patent and Trademark Office, Board of Patent Appeals and Interferences.

Smith, Newman, and Bissell, Circuit Judges. Newman, Circuit Judge, concurring in part, dissenting in part. Smith

SMITH, Circuit Judge.

This appeal is from the decision of the Patent and Trademark Office (PTO) Board of Patent Appeals and Interferences (board) affirming the rejection of all remaining claims in appellant's application for a patent, serial No. 188,735, entitled "Immunoassay Utilizing Monoclonal High Affinity IgM Antibodies," which was filed September 19, 1980.*fn1 The rejection under 35 U.S.C. § 112, first paragraph, is based on the grounds that appellant's written specification would not enable a person skilled in the art to make the monoclonal antibodies that are needed to practice the claimed invention without undue experimentation. We reverse.

I. Issue

The only issue on appeal is whether the board erred, as a matter of law, by sustaining the examiner's rejection for lack of enablement under 35 U.S.C. § 112, first paragraph, of all remaining claims in appellants' patent application, serial No. 188,735.

II. Background

A. The Art.

The claimed invention involves immunoassay methods for the detection of hepatitis B surface antigen by using high-affinity monoclonal antibodies of the IgM isotype. Antibodies are a class of proteins (immunoglobulins) that help defend the body against invaders such as viruses and bacteria. An antibody has the potential to bind tightly to another molecule, which molecule is called an antigen. The body has the ability to make millions of different antibodies that bind to different antigens. However, it is only after exposure to an antigen that a complicated immune response leads to the production of antibodies against that antigen. For example, on the surface of hepatitis B virus particles there is a large protein called hepatitis B surface antigen (HBsAg). As its name implies, it is capable of serving as an antigen. During a hepatitis B infection (or when purified HBsAg is injected experimentally), the body begins to make antibodies that bind tightly and specifically to HBsAg. Such antibodies can be used as reagents for sensitive diagnostic tests (e.g., to detect hepatitis B virus in blood and other tissues, a purpose of the claimed invention). A method for detecting or measuring antigens by using antibodies as reagents is called an immunoassay.

Normally, many different antibodies are produced against each antigen. One reason for this diversity is that different antibodies are produced that bind to different regions (determinants) of a large antigen molecule such as HBsAg. In addition, different antibodies may be produced that bind to the same determinant. These usually differ in the tightness with which they bind to the determinant. Affinity is a quantitative measure of the strength of antibody-antigen binding. Usually an antibody with a higher affinity for an antigen will be more useful for immunological diagnostic tests than one with a lower affinity. Another source of heterogeneity is that there are several immunoglobulin classes or isotypes. Immunoglobulin G (IgG) is the most common isotype in serum. Another isotype, immunoglobulin M

http://in.findacase.com/research/wfrmDocViewer.aspx/xq/fac.19880930_0040210.cfc.htm/qx#D*fn1


(IgM), is prominent early in the immune response. IgM molecules are larger than IgG molecules, and have 10 antigen-binding sites instead of the 2 that are present in IgG. Most immunoassay methods use IgG, but the claimed invention uses only IgM antibodies.

For commercial applications there are many disadvantages to using antibodies from serum. Serum contains a complex mixture of antibodies against the antigen of interest within a much larger pool of antibodies directed at other antigens. These are available only in a limited supply that ends when the donor dies. The goal of monoclonal antibody technology is to produce an unlimited supply of a single purified antibody.

The blood cells that make antibodies are lymphocytes. Each lymphocyte makes only one kind of antibody. During an immune response, lymphocytes exposed to their particular antigen divide and mature. Each produces a clone of identical daughter cells, all of which secrete the same antibody. Clones of lymphocytes, all derived from a single lymphocyte, could provide a source of a single homogeneous antibody. However, lymphocytes do not survive for long outside of the body in cell culture.

Hybridoma technology provides a way to obtain large numbers of cells that all produce the same antibody. This method takes advantage of the properties of myeloma cells derived from a tumor of the immune system. The cancerous myeloma cells can divide indefinitely in vitro. They also have the potential ability to secrete antibodies. By appropriate experimental manipulations, a myeloma cell can be made to fuse with a lymphocyte to produce a single hybrid cell (hence, a hybridoma) that contains the genetic material of both cells. The hybridoma secretes the same antibody that was made by its parent lymphocyte, but acquires the capability of the myeloma cell to divide and grow indefinitely in cell culture. Antibodies produced by a clone of hybridoma cells (i.e., by hybridoma cells that are all progeny of a single cell) are called monoclonal antibodies.*fn2

B. The Claimed Invention.

The claimed invention involves methods for the immunoassay of HBsAg by using high-affinity monoclonal IgM antibodies. Jack R. Wands and Vincent R. Zurawski, Jr., two of the three coinventors of the present application, disclosed methods for producing monoclonal antibodies against HBsAg in United States patent No. 4,271,145 (the '145 patent), entitled "Process for Producing Antibodies to Hepatitis Virus and Cell Lines Therefor," which patent issued on June 2, 1981. The '145 patent is incorporated by reference into the application on appeal. The specification of the '145 patent teaches a procedure for immunizing mice against HBsAg, and the use of lymphocytes from these mice to produce hybridomas that secrete monoclonal antibodies specific for HBsAg. The '145 patent discloses that this procedure yields both IgG and IgM antibodies with high-affinity binding to HBsAg. For the stated purpose of complying with the best mode requirement of 35 U.S.C. § 112, first paragraph, a hybridoma cell line that secretes IgM antibodies against HBsAg (the 1F8 cell line) was deposited at the American Type Culture Collection, a recognized cell depository, and became available to the public when the '145 patent issued.

The application on appeal claims methods for immunoassay of HBsAg using monoclonal antibodies such as those described in the '145 patent. Most immunoassay methods have used monoclonal antibodies of the IgG isotype. IgM antibodies were disfavored in the prior art because of their sensitivity to reducing agents and their tendency to self-aggregate and precipitate. Appellants found that their monoclonal IgM antibodies could be used for immunoassay of HbsAg with unexpectedly high sensitivity and specificity. Claims 1, 3, 7, 8, 14, and 15 are drawn to methods for the immunoassay of HBsAg using high-affinity IgM monoclonal antibodies. Claims 19 and 25-27 are for chemically modified (e.g., radioactively labeled) monoclonal IgM antibodies used in the assays. The broadest method claim reads:

1. An immunoassay method utilizing an antibody to assay for a substance comprising hepatitis B-surface antigen (HBsAg) determinants which comprises the steps of:



contacting a test sample containing said substance comprising HBsAg determinants with said antibody; and

determining the presence of said substance in said sample;

wherein said antibody is a monoclonal high affinity IgM antibody having a binding affinity constant for said HBsAg determinants of at least 10 M.

Certain claims were rejected under 35 U.S.C. § 103; these rejections have not been appealed. Remaining claims 1, 3, 7, 8, 14, 15, 19, and 25-27 were rejected under 35 U.S.C. § 112, first paragraph, on the grounds that the disclosure would not enable a person skilled in the art to make and use the invention without undue experimentation. The rejection is directed solely to whether the specification enables one skilled in the art to make the monoclonal antibodies that are needed to practice the invention. The position of the PTO is that data presented by Wands show that the production of high-affinity IgM anti-HBsAg antibodies is unpredictable and unreliable, so that it would require undue experimentation for one skilled in the art to make the antibodies.

III. Analysis

A. Enablement by Deposit of Microorganisms and Cell Lines.

The first paragraph of 35 U.S.C. § 112 requires that the specification of a patent must enable a person skilled in the art to make and use the claimed invention. "Patents * * * are written to enable those skilled in the art to practice the invention."*fn3 A patent need not disclose what is well known in the art.*fn4Although we review underlying facts found by the board under a "clearly erroneous" standard,*fn5 we review enablement as a question of law.*fn6

Where an invention depends on the use of living materials such as microorganisms or cultured cells, it may be impossible to enable the public to make the invention (i.e., to obtain these living materials) solely by means of a written disclosure. One means that has been developed for complying with the enablement requirement is to deposit the living materials in cell depositories which will distribute samples to the public who wish to practice the invention after the patent issues.*fn7Administrative guidelines and judicial decisions have clarified the conditions under which a deposit of organisms can satisfy the requirements of section 112.*fn8 A deposit has been held necessary for enablement where the starting materials (i.e., the living cells used to practice the invention, or cells from which the required cells can be produced) are not readily available to the public.*fn9 Even when starting materials are available, a deposit has been necessary where it would require undue experimentation to make the cells of the invention from the starting materials.*fn10

In addition to satisfying the enablement requirement, deposit of organisms also can be used to establish the filing date of the application as the prima facie date of invention,*fn11 and to satisfy the requirement under 35 U.S.C. § 114 that the PTO be guaranteed access to the invention during pendency of the application.*fn12 Although a deposit may serve these purposes, we recognized, in In re Lundak,*fn13 that these purposes, nevertheless, may be met in ways other than by making a deposit.

A deposit also may satisfy the best mode requirement of section 112, first paragraph, and it is for this reason that the 1F8 hybridoma was deposited in connection with the '145 patent and the current application. Wands does not challenge the statements by the examiner to the effect that, although the deposited 1F8 line enables the public to perform immunoassays with antibodies produced by that single hybridoma, the deposit does not enable the generic claims that are on appeal. The examiner rejected the claims on the grounds that the written disclosure was not enabling and that the deposit was inadequate. Since we hold that the written disclosure fully enables the claimed invention, we need not reach the question of the adequacy of deposits.

B. Undue Experimentation.













Although inventions involving microorganisms or other living cells often can be enabled by a deposit,*fn14 a deposit is not always necessary to satisfy the enablement requirement.*fn15 No deposit is necessary if the biological organisms can be obtained from readily available sources or derived from readily available starting materials through routine screening that does not require undue experimentation.*fn16 Whether the specification in an application involving living cells (here, hybridomas) is enabled without a deposit must be decided on the facts of the particular case.*fn17

Appellants contend that their written specification fully enables the practice of their claimed invention because the monoclonal antibodies needed to perform the immunoassays can be made from readily available starting materials using methods that are well known in the monoclonal antibody art. Wands states that application of these methods to make high-affinity IgM anti-HBsAg antibodies requires only routine screening, and that does not amount to undue experimentation. There is no challenge to their contention that the starting materials (i.e., mice, HBsAg antigen, and myeloma cells) are available to the public. The PTO concedes that the methods used to prepare hybridomas and to screen them for high-affinity IgM antibodies against HBsAg were either well known in the monoclonal antibody art or adequately disclosed in the '145 patent and in the current application. This is consistent with this court's recognition with respect to another patent application that methods for obtaining and screening monoclonal antibodies were well known in 1980.*fn18 The sole issue is whether, in this particular case, it would require undue experimentation to produce high-affinity IgM monoclonal antibodies.

Enablement is not precluded by the necessity for some experimentation such as routine screening.*fn19 However, experimentation needed to practice the invention must not be undue experimentation.*fn20 "The key word is 'undue,' not 'experimentation.'"*fn21

The determination of what constitutes undue experimentation in a given case requires the application of a standard of reasonableness, having due regard for the nature of the invention and the state of the art. Ansul Co. v. Uniroyal, Inc. [448 F.2d 872, 878-79; 169 USPQ 759, 762-63 (2d Cir. 1971), cert. denied, 404 U.S. 1018, 30 L. Ed. 2d 666, 92 S. Ct. 680 (1972)]. The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed * * *.*fn22

The term "undue experimentation" does not appear in the statute, but it is well established that enablement requires that the specification teach those in the art to make and use the invention without undue experimentation.*fn23 Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations. The board concluded that undue experimentation would be needed to practice the invention on the basis of experimental data presented by Wands. These data are not in dispute. However, Wands and the board disagree strongly on the conclusion that should be drawn from that data.

Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in In re Forman.*fn24 They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.*fn25

In order to understand whether the rejection was proper, it is necessary to discuss further the methods for making specific monoclonal antibodies. The first step for making monoclonal antibodies is to immunize an animal. The '145 patent provides a detailed description of procedures for immunizing a specific strain of mice against HBsAg. Next the spleen, an organ rich in lymphocytes, is removed and the lymphocytes are separated from the other spleen cells. The lymphocytes are mixed with myeloma cells, and the mixture is treated to cause a few of the cells to fuse with each other. Hybridoma cells that secrete the desired antibodies then must be isolated from the enormous number of other cells in the mixture. This is done through a series of screening procedures.














The first step is to separate the hybridoma cells from unfused lymphocytes and myeloma cells. The cells are cultured in a medium in which all the lymphocytes and myeloma cells die, and only the hybridoma cells survive. The next step is to isolate and clone hybridomas that make antibodies that bind to the antigen of interest. Single hybridoma cells are placed in separate chambers and are allowed to grow and divide. After there are enough cells in the clone to produce sufficient quantities of antibody to analyze, the antibody is assayed to determine whether it binds to the antigen. Generally, antibodies from many clones do not bind the antigen, and these clones are discarded. However, by screening enough clones (often hundreds at a time), hybridomas may be found that secrete antibodies against the antigen of interest.

Wands used a commercially available radioimmunoassay kit to screen clones for cells that produce antibodies directed against HBsAg. In this assay the amount of radioactivity bound gives some indication of the strength of the antibody-antigen binding, but does not yield a numerical affinity constant, which must be measured using the more laborious Scatchard analysis. In order to determine which anti-HBsAg antibodies satisfy all of the limitations of appellants' claims, the antibodies require further screening to select those which have an IgM isotype and have a binding affinity constant of at least 10.*fn26 The PTO does not question that the screening techniques used by Wands were well known in the monoclonal antibody art.

During prosecution Wands submitted a declaration under 37 C.F.R. § 1.132 providing information about all of the hybridomas that appellants had produced before filing the patent application. The first four fusions were unsuccessful and produced no hybridomas. The next six fusion experiments all produced hybridomas that made antibodies specific for HBsAg. Antibodies that bound at least 10,000 cpm in the commercial radioimmunoassay were classified as "high binders." Using this criterion, 143 high-binding hybridomas were obtained. In the declaration, Wands stated that*fn27

It is generally accepted in the art that, among those antibodies which are binders with 50,000 cpm or higher, there is a very high likelihood that high affinity (Ka [greater than] 10 M) antibodies will be found. However, high affinity antibodies can also be found among high binders of between 10,000 and 50,000, as is clearly demonstrated in the Table.

The PTO has not challenged this statement.

The declaration stated that a few of the high-binding monoclonal antibodies from two fusions were chosen for further screening. The remainder of the antibodies and the hybridomas that produced them were saved by freezing. Only nine antibodies were subjected to further analysis. Four (three from one fusion and one from another fusion) fell within the claims, that is, were IgM antibodies and had a binding affinity constant of at least 10 M. Of the remaining five antibodies, three were found to be IgG, while the other two were IgM for which the affinity constants were not measured (although both showed binding well above 50,000 cpm).

Apparently none of the frozen cell lines received any further analysis. The declaration explains that after useful high-affinity IgM monoclonal antibodies to HBsAg had been found, it was considered unnecessary to return to the stored antibodies to screen for more IgMs. Wands says that the existence of the stored hybridomas was disclosed to the PTO to comply with the requirement under 37 C.F.R. § 1.56 that applicants fully disclose all of their relevant data, and not just favorable results.*fn28 How these stored hybridomas are viewed is central to the positions of the parties.

The position of the board emphasizes the fact that since the stored cell lines were not completely tested, there is no proof that any of them are IgM antibodies with a binding affinity constant of at least 10 M. Thus, only 4 out of 143 hybridomas, or 2.8 percent, were proved to fall within the claims. Furthermore, antibodies that were proved to be high-affinity IgM came from only 2 of 10 fusion experiments. These statistics are viewed by the board as evidence that appellants' methods were not predictable or reproducible. The board concludes that Wands' low rate of demonstrated success shows that a person skilled in the art would have to engage in undue experimentation in order to make antibodies that fall within the claims.





Wands views the data quite differently. Only nine hybridomas were actually analyzed beyond the initial screening for HBsAg binding. Of these, four produced antibodies that fell within the claims, a respectable 44 percent rate of success. (Furthermore, since the two additional IgM antibodies for which the affinity constants were never measured showed binding in excess of 50,000 cpm, it is likely that these also fall within the claims.) Wands argues that the remaining 134 unanalyzed, stored cell lines should not be written off as failures. Instead, if anything, they represent partial success. Each of the stored hybridomas had been shown to produce a high-binding antibody specific for HBsAg. Many of these antibodies showed binding above 50,000 cpm and are thus highly likely to have a binding affinity constant of at least 10 M. Extrapolating from the nine hybridomas that were screened for isotype (and from what is well known in the monoclonal antibody art about isotype frequency), it is reasonable to assume that the stored cells include some that produce IgM. Thus, if the 134 incompletely analyzed cell lines are considered at all, they provide some support (albeit without rigorous proof) to the view that hybridomas falling within the claims are not so rare that undue experimentation would be needed to make them.

The first four fusion attempts were failures, while high-binding antibodies were produced in the next six fusions. Appellants contend that the initial failures occurred because they had not yet learned to fuse cells successfully. Once they became skilled in the art, they invariably obtained numerous hybridomas that made high-binding antibodies against HBsAg and, in each fusion where they determined isotype and binding affinity they obtained hybridomas that fell within the claims.

Wands also submitted a second declaration under 37 C.F.R. § 1.132 stating that after the patent application was submitted they performed an eleventh fusion experiment and obtained another hybridoma that made a high-affinity IgM anti-HBsAg antibody. No information was provided about the number of clones screened in that experiment. The board determined that, because there was no indication as to the number of hybridomas screened, this declaration had very little value. While we agree that it would have been preferable if Wands had included this information, the declaration does show that when appellants repeated their procedures they again obtained a hybridoma that produced an antibody that fit all of the limitations of their claims.

We conclude that the board's interpretation of the data is erroneous. It is strained and unduly harsh to classify the stored cell lines (each of which was proved to make high-binding antibodies against HBsAg) as failures demonstrating that Wands' methods are unpredictable or unreliable.*fn29 At worst, they prove nothing at all about the probability of success, and merely show that appellants were prudent in not discarding cells that might someday prove useful. At best, they show that high-binding antibodies, the starting materials for IgM screening and Scatchard analysis, can be produced in large numbers. The PTO's position leads to the absurd conclusion that the more hybridomas an applicant makes and saves without testing, the less predictable the applicant's results become. Furthermore, Wands' explanation that the first four attempts at cell fusion failed only because they had not yet learned to perform fusions properly is reasonable in view of the fact that the next six fusions were all successful. The record indicates that cell fusion is a technique that is well known to those of ordinary skill in the monoclonal antibody art, and there has been no claim that the fusion step should be more difficult or unreliable where the antigen is HBsAg than it would be for other antigens.

When Wands' data is interpreted in a reasonable manner, analysis considering the factors enumerated in In re Forman leads to the conclusion that undue experimentation would not be required to practice the invention. Wands' disclosure provides considerable direction and guidance on how to practice their invention and presents working examples. There was a high level of skill in the art at the time when the application was filed, and all of the methods needed to practice the invention were well known.

The nature of monoclonal antibody technology is that it involves screening hybridomas to determine which ones secrete antibody with desired characteristics. Practitioners of this art are prepared to screen negative hybridomas in order to find one that makes the desired antibody. No evidence was presented by either party on how many hybridomas would be viewed by those in the art as requiring undue experimentation to screen. However, it seems unlikely that undue experimentation would be defined in terms of the number of hybridomas that were never screened. Furthermore, in the monoclonal antibody



art it appears that an "experiment" is not simply the screening of a single hybridoma, but is rather the entire attempt to make a monoclonal antibody against a particular antigen. This process entails immunizing animals, fusing lymphocytes from the immunized animals with myeloma cells to make hybridomas, cloning the hybridomas, and screening the antibodies produced by the hybridomas for the desired characteristics. Wands carried out this entire procedure three times, and was successful each time in making at least one antibody that satisfied all of the claim limitations. Reasonably interpreted, Wands' record indicates that, in the production of high-affinity IgM antibodies against HBsAG, the amount of effort needed to obtain such antibodies is not excessive. Wands' evidence thus effectively rebuts the examiner's challenge to the enablement of their disclosure.*fn30

IV. Conclusion

Considering all of the factors, we conclude that it would not require undue experimentation to obtain antibodies needed to practice the claimed invention. Accordingly, the rejection of Wands' claims for lack of enablement under 35 U.S.C. § 112, first paragraph, is reversed.

REVERSED

NEWMAN, Circuit Judge, concurring in part, dissenting in part.

A

I concur in the court's holding that additional samples of hybridoma cell lines that produce these high-affinity IgM monoclonal antibodies need not be deposited. This invention, as described by Wands, is not a selection of a few rare cells from many possible cells. To the contrary, Wands states that all monoclonally produced IgM antibodies to hepatitis B surface antigen have the desired high avidity and other favorable properties, and that all are readily preparable by now-standard techniques.

Wands states that his United States Patent No. 4,271,145 describes fully operable techniques, and is distinguished from his first four failed experiments that are referred to in the Rule 132 affidavit. Wands argues that these biotechnological mechanisms are relatively well understood and that the preparations can be routinely duplicated by those of skill in this art, as in Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1380, 231 USPQ 81, 94 (Fed. Cir. 1986), cert. denied, 480 U.S. 947, 107 S. Ct. 1606, 94 L. Ed. 2d 792 (1987). I agree that it is not necessary that there be a deposit of multiple exemplars of a cell system that is readily reproduced by known, specifically identified techniques.

B

I would affirm the board's holding that Wands has not complied with 35 U.S.C. § 112, first paragraph, in that he has not provided data sufficient to support the breadth of his generic claims. Wands' claims on appeal include the following:

19. Monoclonal high affinity IgM antibodies immunoreactive with HBsAg determinants, wherein said antibodies are coupled to an insoluble solid phase, and wherein the binding affinity constant of said antibodies for said HBsAg determinants is at least 10 M.

26. Monoclonal high affinity IgM antibodies immunoreactive with HBsAg determinants wherein said antibodies are detectably labelled.

Wands states that he obtained 143 "high binding monoclonal antibodies of the right specificity" in the successful fusions; although he does not state how they were determined to be high binding or of the right specificity, for Wands also states that only nine of these 143 were tested.

Of these nine, four (three from one fusion and one from another fusion) were found to have the claimed high affinity and to be of the IgM isotype. Wands states that the other five were either of a different



isotype or their affinities were not determined. (This latter statement also appears to contradict his statement that all 143 were "high binding".)

Wands argues that a "success rate of four out of nine", or 44.4%, is sufficient to support claims to the entire class. The Commissioner deems the success rate to be four out of 143, or 2.8%; to which Wands responds with statistical analysis as to how unlikely it is that Wands selected the only four out of 143 that worked. Wands did not, however, prove the right point. The question is whether Wands, by testing nine out of 143 (the Commissioner points out that the randomness of the sample was not established), and finding that four out of the nine had the desired properties, has provided sufficient experimental support for the breadth of the requested claims, in the context that "experiments in genetic engineering produce, at best, unpredictable results", quoting from Ex parte Forman, 230 USPQ 546, 547 (Bd.Pat.App. and Int. 1986).

The premise of the patent system is that an inventor, having taught the world something it didn't know, is encouraged to make the product available for public and commercial benefit, by governmental grant of the right to exclude others from practice of that which the inventor has disclosed. The boundary defining the excludable subject matter must be carefully set: it must protect the inventor, so that commercial development is encouraged; but the claims must be commensurate with the inventor's contribution. Thus the specification and claims must meet the requirements of 35 U.S.C. § 112. In re Fisher, 57 C.C.P.A. 1099, 427 F.2d 833, 839, 166 USPQ 18, 23-24 (CCPA 1970).

As the science of biotechnology matures the need for special accommodation, such as the deposit of cell lines or microorganisms, may diminish; but there remains the body of law and practice on the need for sufficient disclosure, including experimental data when appropriate, that reasonably support the scope of the requested claims. That law relates to the sufficiency of the description of the claimed invention, and if not satisfied by deposit, must independently meet the requirements of Section 112.

Wands is not claiming a particular, specified IgM antibody. He is claiming all such monoclonal antibodies in assay for hepatitis B surface antigen, based on his teaching that such antibodies have uniformly reproducible high avidity, free of the known disadvantages of IgM antibodies such as tendency to precipitate or aggregate. It is incumbent upon Wands to provide reasonable support for the proposed breadth of his claims. I agree with the Commissioner that four exemplars shown to have the desired properties, out of the 143, do not provide adequate support.

Wands argues that the law should not be "harsher" where routine experiments take a long time. However, what Wands is requesting is that the law be less harsh. As illustrated in extensive precedent on the question of how much experimentation is "undue", each case must be determined on its own facts. See, e.g., W.L. Gore & Assocs., Inc. v. Garlock, Inc. 721 F.2d 1540, 1557, 220 USPQ 303, 316 (Fed. Cir. 1983), cert. denied, 469 U.S. 851, 105 S. Ct. 172, 83 L. Ed. 2d 107 (1984); In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 218 (CCPA 1976); In re Cook, 58 C.C.P.A. 1049, 439 F.2d 730, 734-35, 169 USPQ 298, 302-03 (CCPA 1971).

The various criteria to be considered in determining whether undue experimentation is required are discussed in, for example, Fields v. Conover, 58 C.C.P.A. 1366, 443 F.2d 1386, 170 USPQ 276 (CCPA 1971); In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 USPQ 218 (CCPA 1965); Ex parte Forman, 230 USPQ at 547. Wands must provide sufficient data or authority to show that his results are reasonably predictable within the scope of the claimed generic invention, based on experiment and/or scientific theory. In my view he has not met this burden.


b. Speculation and Prophesy • case: Janssen Pharma v. Teva Pharms

In re '318 Patent Infringement Litigation

United States Court of Appeals for the Federal Circuit

September 25, 2009 IN RE '318 PATENT INFRINGEMENT LITIGATION JANSSEN PHARMACEUTICA N.V., JANSSEN L.P., AND SYNAPTECH, INC., PLAINTIFFS-APPELLANTS, v. TEVA PHARMACEUTICALS USA, INC. AND TEVA PHARMACEUTICAL INDUSTRIES, LTD., DEFENDANTS, AND MYLAN PHARMACEUTICALS, INC. AND MYLAN LABORATORIES, INC., DEFENDANTS-APPELLEES, AND DR. REDDY'S LABORATORIES, INC. AND DR. REDDY'S LABORATORIES, LTD., DEFENDANTS, AND BARR LABORATORIES, INC., DEFENDANT-APPELLEE, AND PUREPAC PHARMACEUTICAL CO. AND ACTAVIS GROUP, DEFENDANTS, AND ALPHAPHARM PTY LTD., DEFENDANT-APPELLEE. JANSSEN PHARMACEUTICA, N.V., JANSSEN, L.P., ORTHO-MCNEIL NEUROLOGICS, INC., AND SYNAPTECH, INC., PLAINTIFFS-APPELLANTS, v. BARR LABORATORIES, INC., AND BARR PHARMACEUTICALS, INC., DEFENDANTS-APPELLEES.

Appeals from the United States District Court for the District of Delaware, in consolidated case nos. 05-CV-356, 05-CV-371, 05-CV-380, 05-CV-381, 05-CV-382, 05-CV-420, and 05-CV-451, Judge Sue L. Robinson. Appeal from the United States District Court for the District of New Jersey in case no. 06-CV-3008, Judge Joel A. Pisano.

The opinion of the court was delivered by: Dyk, Circuit Judge

Published opinion

Before MAYER, GAJARSA, and DYK, Circuit Judges.

Opinion for the court filed by Circuit Judge DYK. Dissenting opinion filed by Circuit Judge GAJARSA.

Janssen Pharmaceutica N.V., Janssen L.P., and Synaptech, Inc. ("Janssen"), appeal from a final judgment of the United States District Court for the District of Delaware. After a bench trial, the district court determined that the claims of U.S. Patent No. 4,663,318 ("the '318 patent") were invalid for lack of enablement. In re '318 Patent Infringement Litig., 578 F. Supp. 2d 711, 737 (D. Del. 2008). We affirm.

BACKGROUND

Janssen's '318 patent claims a method for treating Alzheimer's disease with galanthamine. Claim 1 is representative. It claims "[a] method of treating Alzheimer's disease and related dementias which comprises administering to a patient suffering from such a disease a therapeutically effective amount of galanthamine or a pharmaceutically-acceptable acid addition salt thereof." '318 patent col.3 ll.6--10.*fn1 The application for the '318 patent was filed on January 15, 1986, by Dr. Bonnie Davis, the claimed inventor.

http://tn.findacase.com/research/wfrmDocViewer.aspx/xq/fac.20090925_0000504.cfc.htm/qx#D*fn1


Alzheimer's disease is a form of progressive dementia in which memory and mental abilities steadily decline. At the time of the '318 patent's application in early 1986, researchers had observed a correlation between Alzheimer's disease symptoms and a reduced level of the neurotransmitter acetylcholine in the brain. During neurotransmission, acetylcholine is released by a transmitting neuron and binds to receptors on a receiving neuron. The two main types of acetylcholine receptors are nicotinic receptors and muscarinic receptors. Nicotinic and muscarinic receptors are present in neurons in both the central nervous system (which includes the brain and spinal cord) and the peripheral nervous system (which connects the central nervous system to muscles and organs).

In early 1986, many researchers focused primarily on the importance of central nervous system muscarinic receptors in developing treatments for Alzheimer's disease. At that time, galanthamine (also spelled "galantamine"), a small molecule compound, was known to inhibit acetylcholinesterase, an enzyme that breaks down acetylcholine. Acetylcholinesterase inhibitors like galantamine increase the amount of acetylcholine available for binding to muscarinic or nicotinic receptors.

The specification for the '318 patent was only just over one page in length, and it provided almost no basis for its stated conclusion that it was possible to administer "an effective Alzheimer's disease cognitively-enhancing amount of galanthamine." Id. col.1 ll.47--48. The specification provided short summaries of six scientific papers in which galantamine had been administered to humans or animals.*fn2 The specification summarized the first paper as showing that administering galantamine with the drug atropine to humans under anesthesia raised blood levels of the hormone cortisol, and the second paper as showing that administering galantamine and atropine together during anesthesia also raised levels of adrenocorticotropic hormone ("ACTH") in humans. See id. col.1 ll.13--21. There was no explanation of the significance of increasing cortisol or ACTH levels, but it was known to those skilled in the art in early 1986 that the production of cortisol and ACTH was controlled by the central nervous system rather than the peripheral nervous system, and that the studies thus suggested that galantamine was able to cross the blood-brain barrier and have effects within the brain.

The specification then provided brief summaries of four scientific papers reporting brain effects and positive effects on memory from administering galantamine to animals. See id. col.1 ll.22--33. The first paper concluded that galantamine intravenously administered to rabbits affected brain wave activity. The second paper concluded that galantamine increased short-term memory in dogs. The third and fourth papers concluded that galantamine reversed amnesia in rats that had been induced by administering the drug scopolamine. The specification did not suggest that such scopolamine-induced amnesia was similar to Alzheimer's disease. The specification did not provide analysis or insight connecting the results of any of these six studies to galantamine's potential to treat Alzheimer's disease in humans.

The specification noted that another prior art scientific paper described an animal testing model for replicating in animals the acetylcholine deficit and other effects of Alzheimer's disease.*fn3 The specification agreed that acetylcholine deficiency in animals is a "good animal model for Alzheimer's disease in humans" because the deficiency produces "[n]umerous behavioral deficits, including the inability to learn and retain new information." Id. col.2 ll.50--52. The specification cited the prior art for the conclusion that "[d]rugs that can normalize these abnormalities would have a reasonable expectation of efficacy in Alzheimer's disease." Id. col.2 ll.52--54. However, the specification did not refer to any then-existing animal test results involving the administration of galantamine in connection with this animal model of Alzheimer's disease.

In April 1986 an examiner at the United States Patent and Trademark Office ("PTO") rejected the claims in the '318 patent's application for indefiniteness and obviousness. The examiner found the patent application's claim of a method of "diagnosing" Alzheimer's disease to be indefinite, because diagnosing "has nothing to do with treating" and because the claims thus "fail[ed] to particularly point out and distinctly claim the subject matter which applicant regards as the invention." J.A. 4108. The examiner also found the patent application's claim of a method of treating Alzheimer's disease obvious-in light of the animal studies cited in the specification describing the use of galantamine to treat scopolamine-




induced amnesia and in improving short-term memory. The examiner did not reject the application for lack of enablement.

In September 1986 the applicant, Dr. Davis, responded to the examiner's indefiniteness rejection by narrowing the claim language, deleting the words "and diagnosing" from the original application's claim of "[a] method of treating and diagnosing Alzheimer's disease." Dr. Davis responded to the obviousness rejection by explaining that, because the brains of the animals in the studies cited in the specification were "normal" (rather than having "physiological changes" similar to Alzheimer's disease), the studies were conducted under "circumstances having no relevance to Alzheimer's disease," and that it thus would be "baseless" to predict from such studies that galantamine would be useful to treat Alzheimer's disease. J.A. 4407.

In addition, Dr. Davis responded by stating that "experiments [are] underway using animal models which are expected to show that treatment with galanthamine does result in an improvement in the condition of those suffering from Alzheimer's disease," and that it was "expected that data from this experimental work will be available in two to three months and will be submitted to the Examiner promptly thereafter." J.A. 4405. The '318 patent issued on May 5, 1987. Dr. Davis did not learn the results of the animal testing experiments-which suggested that galantamine could be a promising Alzheimer's disease treatment-until July 1987, after the '318 patent had issued. These studies required several months and considerable effort by researchers at the Johns Hopkins University under the supervision of Dr. Joseph T. Coyle. No such testing results were ever submitted to the PTO.

After the '318 patent issued in May 1987, Dr. Davis licensed the patent in November 1995 to Janssen. In February 2001 Janssen received approval from the Food and Drug Administration ("FDA") for using galantamine to treat mild to moderate Alzheimer's disease.

In February 2005 several generic drug manufacturers filed abbreviated new drug applications ("ANDAs") and so-called "Paragraph IV" certifications with the FDA, and Janssen sued each manufacturer for infringing the '318 patent.*fn4 The actions were consolidated, the defendants conceded infringement of claims 1 and 4 of the '318 patent, and a bench trial was held in May 2007 on the invalidity issues of anticipation, obviousness, and enablement.

The district court found that the '318 patent was neither anticipated nor obvious. However, the district court concluded that the '318 patent was invalid for lack of enablement on two distinct grounds. The district court found that the specification did not demonstrate utility because relevant animal testing experiments were "not finished . . . by the time the '318 patent was allowed" and the specification provided only "minimal disclosure" of utility. '318 Patent Infringement Litig., 578 F. Supp. 2d at 723, 735; see also id. at 736--37 & n.39. The district court alternatively found that the specification and claims did not "teach one of skill in the art how to use the claimed method" because the application "only surmise[d] how the claimed method could be used" without providing sufficient galantamine dosage information. Id. at 736. The district court entered judgment in favor of the defendants that the '318 patent was invalid for lack of enablement.

Janssen timely appealed. We have jurisdiction under 28 U.S.C. §§ 1291 and 1295(a)(1).

DISCUSSION

Enablement is a question of law we review without deference. Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1070 (Fed. Cir. 2005). We review the factual issues underlying enablement for clear error. Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1369 (Fed. Cir. 1999).

The enablement requirement is stated in 35 U.S.C. § 112.*fn5 Enablement is determined as of the effective filing date of the patent's application. Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339 (Fed. Cir. 2003).




Enablement is closely related to the requirement for utility.*fn6 As we noted in Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1358 (Fed. Cir. 1999),

The enablement requirement of 35 U.S.C. § 112, ¶ 1 requires that the specification adequately discloses to one skilled in the relevant art how to make, or in the case of a process, how to carry out, the claimed invention without undue experimentation. The utility requirement of 35 U.S.C. § 101 mandates that any patentable invention be useful and, accordingly, the subject matter of the claim must be operable. If a patent claim fails to meet the utility requirement because it is not useful or operative, then it also fails to meet the how-to-use aspect of the enablement requirement. (emphasis added, citations and footnote omitted). See also 3 Donald A. Chisum, Chisum on Patents § 7.03(6) (2007). The Supreme Court in Brenner v. Manson, 383 U.S. 519 (1966), discussing the utility requirement, stated that inventions must have "substantial utility" and "specific benefit exist[ing] in currently available form." Id. at 534-- 35.

The utility requirement prevents mere ideas from being patented. As we noted in Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997), "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. . . . Tossing out the mere germ of an idea does not constitute enabling disclosure." See also In re Fisher, 421 F.3d 1365, 1373 (Fed. Cir. 2005) (inventions fail to meet the utility requirement if their "asserted uses represent merely hypothetical possibilities, objectives which the claimed [inventions] . . . could possibly achieve, but none for which they have been used in the real world").

The utility requirement also prevents the patenting of a mere research proposal or an invention that is simply an object of research. Again as the Supreme Court stated in Brenner, "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion." 383 U.S. at 536. A process or product "which either has no known use or is useful only in the sense that it may be an object of scientific research" is not patentable. Id. at 535. As we observed in Fisher, inventions do not meet the utility requirement if they are "objects upon which scientific research could be performed with no assurance that anything useful will be discovered in the end." 421 F.3d at 1373. Allowing ideas, research proposals, or objects only of research to be patented has the potential to give priority to the wrong party and to "confer power to block off whole areas of scientific development, without compensating benefit to the public." Brenner, 383 U.S. at 534 (footnote omitted).

Typically, patent applications claiming new methods of treatment are supported by test results. But it is clear that testing need not be conducted by the inventor. In addition, human trials are not required for a therapeutic invention to be patentable. Our predecessor court, the United States Court of Customs and Patent Appeals, held in In re Krimmel that patent applications need not "prove that compounds or other materials which [the applicant] is claiming, and which [the applicant] has stated are useful for 'pharmaceutical applications' are safe, effective, and reliable for use with humans." 292 F.2d 948, 954 (CCPA 1961). As we observed in In re Brana, "[w]ere we to require Phase II testing [human trials] in order to prove utility, the associated costs would prevent many companies from obtaining patent protection on promising new inventions, thereby eliminating an incentive to pursue . . . potential cures." 51 F.3d 1560, 1568 (Fed. Cir. 1995); see also Scott v. Finney, 34 F.3d 1058, 1063--64 (Fed. Cir. 1994).

We have held that results from animal tests or in vitro experiments*fn7 may be sufficient to satisfy the utility requirement. Our predecessor court held in Krimmel that animal tests showing that a new nonobvious compound "exhibits some useful pharmaceutical property" are sufficient to demonstrate utility. 292 F.2d at 953. We noted in Cross v. Iizuka that "[w]e perceive no insurmountable difficulty, under appropriate circumstances, in finding that the first link in the screening chain, in vitro testing, may establish a practical utility for the [pharmaceutical] compound in question" in order for a patent to issue. 753 F.2d 1040, 1051 (Fed. Cir. 1985). We concluded that in vitro test results for a claimed pharmaceutical compound, combined with animal test results for a structurally similar compound, showed "a reasonable correlation between the disclosed in vitro utility and an in vivo activity, and therefore a rigorous correlation is not necessary where the disclosure of pharmacological activity is reasonable based upon the probative evidence." Id. at 1050.




In this case, however, neither in vitro test results nor animal test results involving the use of galantamine to treat Alzheimer's-like conditions were provided. The results from the '318 patent's proposed animal tests of galantamine for treating symptoms of Alzheimer's disease were not available at the time of the application, and the district court properly held that they could not be used to establish enablement.*fn8

Nor does Janssen contend that the prior art animal testing summarized in the '318 patent application's specification established utility. Indeed, both in responding to the examiner's obviousness rejection and in responding to the obviousness defense at trial, the inventor (Dr. Davis) and Janssen's witnesses explicitly stated that the utility of the invention could not be inferred from the prior art testing described in the application. The response of the inventor, Dr. Davis, to the examiner's obviousness rejection stated, with regard to studies cited in the specification showing galantamine's ability to reverse scopolamine-induced amnesia in normal rats, that "[n]othing in this teaching leads to an expectation of utility against Alzheimer's disease." J.A. 4409. The response of Dr. Davis also stated that "predict[ing] that galanthamine would be useful in treating Alzheimer's disease just because it has been reported [in the prior art studies cited in the specification] to have an effect on memory in circumstances having no relevance to Alzheimer's disease" would be "as baseless as a prediction that impaired eyesight due to diabetes would respond to devices (eyeglasses) or treatments (eye exercises) known to improve the vision of normal persons." J.A. 4407. Janssen's other expert Dr. Raskind testified that studying a compound's effects on scopolamine-induced amnesia "ignores the whole other [nicotinic] part that's damaged in Alzheimer's disease" and thus "doesn't mimic Alzheimer's disease." J.A. 9301--02. The district court agreed, finding, for example, that the utility of galantamine in treating scopolamine-induced amnesia did not establish galantamine's utility in treating Alzheimer's disease. See '318 Patent Infringement Litig., 578 F. Supp. 2d at 731 ("[S]copolamine['s] . . . usefulness as a model for [Alzheimer's disease] research has limitations. . . . [A] person of skill in the art would not have a reasonable expectation of success for using a drug that worked for scopolamine-induced delirium to treat [Alzheimer's disease].").

However, Janssen argues that in some circumstances utility may be established without testing the proposed treatment in the claimed environment or a sufficiently similar or predictive environment; that is, Janssen argues that utility may be established by analytic reasoning. Although no case has been called to our attention where utility was established simply by analytic reasoning,*fn9 the PTO's Manual of Patent Examining Procedure ("MPEP") has recognized that "arguments or reasoning" may be used to establish an invention's therapeutic utility.*fn10

Janssen goes on to argue that the specification here establishes utility by analytic reasoning. Relying on trial testimony, Janssen reasons that the selection and description of the prior art tests, while not directly pertinent, "set[] forth the evidence from existing studies demonstrating galantamine's effects on central nicotinic as well as muscarinic receptors and connect[ed] it to a model for Alzheimer's therapy rendering those effects therapeutically relevant." Janssen Reply Br. 17 n.2. Janssen asserts that the prior art tests summarized in the specification would lead one skilled in the art to infer that galantamine affected the ability of acetylcholine to bind to both nicotinic and muscarinic receptors in the brain. Janssen also asserts that the animal tests proposed in the specification as a model for Alzheimer's disease would further lead one skilled in the art to infer that the model's method of impairing brain acetylcholine availability would allow both muscarinic and nicotinic effects to be observed. Janssen thus argues that because nicotinic receptors in the brain are involved with the ability to learn, the specification suggested that galantamine could have beneficial effects on learning (unlike prior art treatments, which had primarily affected muscarinic receptors). These insights, however, are nowhere described in the specification. Nor was there evidence that someone skilled in the art would infer galantamine's utility from the specification, even if such inferences could substitute for an explicit description of utility.

Janssen relies on the testimony of its expert Dr. Coyle, the scientist who later supervised the performance of the animal studies suggested in the specification. He testified that the specification "connected the dots" for galantamine as a potential Alzheimer's disease treatment, listing the "dots" as "[g]alanthamine in humans safe and well tolerated[,] [c]holinesterase inhibitor, selective nicotinic





effects, and very modest muscarinic receptor side effects." J.A. 9057--58. This testimony of Dr. Coyle on which Janssen relies, however, characterized the use of galantamine to treat Alzheimer's disease as "a proposal that connected the dots that raised very interesting questions and worth the effort to check it out in a model in which . . . both nicotinic and muscarinic receptors would come into play." Id. (emphases added).*fn11 Similarly, agreement by another of Janssen's expert witnesses, Dr. Raskind, that a person of ordinary skill in the art in early 1986 would have viewed the "invention as set forth in the patent as scientifically grounded" falls far short of demonstrating that a person of ordinary skill in the art would have recognized that the specification conveyed the required assertion of a credible utility. J.A. 9305. In fact, the inventor's own testimony reveals that an ordinarily skilled artisan would not have viewed the patent's disclosure as describing the utility of galantamine as a treatment for Alzheimer's disease: "[W]hen I submitted this patent, I certainly wasn't sure, and a lot of other people weren't sure that cholinesterase inhibitors[, a category of agents that includes galantamine,] would ever work." J.A. 8747; see '318 Patent Infringement Litig., 578 F. Supp. 2d at 736.

Thus, at the end of the day, the specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient. See Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1325 (Fed. Cir. 2005) ("If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to 'inventions' consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the 'inventor' would be rewarded the spoils instead of the party who demonstrated that the method actually worked. That scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis.").

The '318 patent's description of using galantamine to treat Alzheimer's disease thus does not satisfy the enablement requirement because the '318 patent's application did not establish utility.*fn12

CONCLUSION For the foregoing reasons, the decision of the district court is affirmed. AFFIRMED COSTS No costs. GAJARSA, Circuit Judge, dissenting.

I respectfully dissent from the majority's affirmance because the district court did not undertake the required legal analysis to determine whether an ordinarily skilled artisan reading the patent would understand it to reveal a credible utility for the invention. In addition, the district court failed to make the factual findings necessary to support the ultimate legal conclusion regarding enablement. See Koito Mfg. Co. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1149 (Fed. Cir. 2004) ("Enablement is a matter of law that we review without deference; however, this Court reviews the factual underpinnings of enablement for substantial evidence."). Thus, I would vacate the judgment of non-enablement and remand for the district court to make the required factual findings and to perform the necessary legal analysis in the first instance.

The parties do not dispute that Dr. Davis's insight regarding galantamine's utility for treating Alzheimer's Disease (AD) was correct; later animal studies and human clinical trials proved and confirmed galantamine's effectiveness. The relevant question here is whether, at the time Dr. Davis filed her application, the patent's written description would have credibly revealed to an ordinarily skilled artisan galantamine's utility for AD treatment. See In re Cortright, 165 F.3d 1353, 1356 (Fed. Cir. 1999) (noting that the patent's written description must "illuminate a credible utility" to meet the enablement requirement). The district court failed to answer that question. Instead, the district court reasoned:

Dr. Davis did not receive any confirming data until after the '318 patent was allowed. In view of the prior art disclosures regarding the flaws of physostigmine [a compound chemically similar to




galantamine] in AD treatment, discussed previously in the context of obviousness, it does not follow that a person of ordinary skill in the art, reading the '318 patent, would have recognized that galanthamine would be effective in treating AD in the absence of any experimental proof. Put another way, since plaintiffs rely exclusively on the prior art to establish enablement, the court agrees with defendants that the '318 patent cannot both be non-obvious and enabled.

In re '318 Patent Infringement Litig., 578 F. Supp. 2d 711, 736 (D. Del. 2008) (citation and footnote omitted) ("District Court Decision").

The district court's reasoning is flawed. In general terms, an inventor may look at the prior art differently than those before her, arrive at a novel and nonobvious insight, and submit a patent application that compiles the prior art findings that led her to the insight in such a way as to render obvious in hindsight what was wholly nonobvious at the time she filed her application. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007) ("The question is not whether the combination was obvious to the patentee but whether the combination was obvious to a person with ordinary skill in the art."); Grain Processing Corp. v. Am. Maize-Products Co., 840 F.2d 902, 907 (Fed. Cir. 1988) (In considering obviousness, "[c]are must be taken to avoid hindsight reconstruction by using 'the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.'" (quoting Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1012 (Fed. Cir. 1983))). As a result, the proper focus when assessing enablement is on what is disclosed in the patent, not what is taught in the prior art. See In re Ziegler, 992 F.2d 1197, 1201 (Fed. Cir. 1993) ("The how to use prong of section 112 incorporates as a matter of law the requirement of 35 U.S.C. § 101 that the specification disclose as a matter of fact a practical utility for the invention." (emphases added)). In terms of the present case, if Dr. Davis used her unique neuroendocrine perspective to examine the prior art and arrive at a novel insight about galantamine based on selected prior art findings, then the invention may be nonobvious; and if her patent disclosed those selected findings in such a manner that a person of ordinary skill would credit her insight regarding galantamine's utility, then the invention is enabled.

Unfortunately, the district court committed error here by focusing generally on what the prior art does or does not teach-the primary factual consideration underlying obviousness-while neglecting to consider what the patent text discloses to an ordinarily skilled artisan-the primary factual consideration underlying enablement. Specifically, although the '381 patent describes particular findings from six prior art publications, the district court noted only one such publication, see District Court Decision, 578 F. Supp. 2d at 722, and did not determine how one of ordinary skill would understand those cited findings, either independently or in combination with one another. Thus, it is clear that the district court failed to focus on the necessary underlying factual findings required to ascertain how an ordinarily skilled artisan would understand the text of the patent for the purpose of establishing utility and thus enablement. Under the district court's erroneous approach, a court can invalidate for lack of enablement a patent claim to a nonobvious combination of prior art elements without ever considering what the patent actually discloses to one of ordinary skill in the art. That is contrary to law.

Nor was the district court's error harmless. See Majority Op. at 17 n.12. Because the district court failed to make the required fact-findings, which stemmed from its erroneous legal analysis, the majority must engage in extensive appellate fact-finding in order to affirm the district court's judgment. It is improper for an appellate court to become the fact-finder. This court cannot presume to have the skills of the ordinary artisan and cannot substitute its weighing of the evidence and factual conclusions for those of the fact-finder. According to the majority, even though the district court failed to make the appropriate findings or conduct the proper legal analysis, we need not vacate here because "the record would not support a finding of utility." Id. I respectfully disagree. The record clearly includes evidence that may support a finding of utility, which the majority discounts in order to reach its erroneous conclusion.*fn13 For example, Janssen provided evidence indicating that the specific findings recited in the patent, as understood by one of ordinary skill in the art, disclose the following: (1) galantamine administration increases blood cortisol levels and plasma acetylcholine when muscarinic function is blocked, an indication that galantamine increases the function of central nicotinic receptors, J.A. 8906--07; J.A. 9296--97; J.A. 9302--03; (2) galantamine can cross into the brain and affect brain function,



J.A. 9298; J.A. 9303; (3) galantamine also has muscarinic effects in the brain, as indicated by its ability to improve memory in animals that have been administered scopolamine (a muscarinic receptor blocker) to induce amnesia, J.A. 8250; J.A. 8963; J.A. 9298--99; and (4) the patent discloses the importance of nicotinic receptors in AD by describing an animal model for AD that includes muscarinic and nicotinic receptors, J.A. 9302. Thus, one of ordinary skill- having the relevant background knowledge and reading the patent text at the time the application was filed-may have understood the patent to disclose the importance of nicotinic receptors in AD intervention and galantamine's promising effects on nicotinic function and memory, such that she would recognize in the patent text galantamine's credible utility as an AD treatment. Moreover, the defendants' expert agreed that "[a] person in 1986 reading the patent would believe that galanthamine would be a treatment for Alzheimer's Disease." J.A. 8327. Although the defendants' expert gave that testimony in support of his assertion that the claims are obvious, see Majority Op. at 15 n.11, the testimony is nonetheless evidence that may support a finding for the patentee on enablement. Because there is evidence of record that supports a conclusion that the '318 patent claims are not invalid, it is inappropriate for this court to weigh the evidence and make contrary factual findings, especially in the absence of any consideration by the district court of numerous prior art references that were specifically discussed in the patent. Thus, in my judgment the district court's failure to make the necessary findings and conduct the proper legal analysis is reversible error. We should remand to the district court for it to make the appropriate factual findings instead of weighing the evidence ourselves.

Finally, I disagree with the majority opinion's emphasis on the sufficiency of the evidence presented by Janssen. As both parties correctly note, the question before us is "whether the defendants have shown, by clear and convincing evidence, that the patent's marshalling of evidence from the technical literature of galantamine's effects, combined with its model for Alzheimer's therapy, is not sufficient for a skilled artisan to believe the invention's utility." Appellant's Br. at 27; Appellee's Br. at 29. That is a correct articulation of the question presented on appeal because, unlike many of the cases upon which the majority and district court rely, the claims in dispute here are issued patent claims, and are thus presumed valid. Yet, the majority fails to establish the defendants' burden and instead focuses almost exclusively on the sufficiency of Janssen's showing and the merit of Janssen's arguments. See, e.g., Majority Op. at 15--16 ("Similarly, [the testimony of Janssen's expert witness, Dr. Raskind] falls far short of demonstrating that a person of ordinary skill in the art would have recognized that the specification conveyed the required showing of utility."). That focus is improper. Because the district court erred as a matter of law and failed to make certain required factual findings, we cannot defer to the district court's legal conclusion or fact-findings, and thus, it is particularly problematic for the majority to require Janssen to demonstrate on appeal that its patent is valid.

For the foregoing reasons, I respectfully dissent from the majority's decision.


c. Uses of examples in the specification • case: In re Meir Strahilevitz

J. Philip Polster, St. Louis, Mo., for appellant. Joseph F. Nakamura, Sol., and Fred W. Sherling, Washington, D.C., for Patent and Trademark Office. Appeal from the Patent and Trademark Office Board of Appeals. Before MARKEY, Chief Judge, and RICH, BALDWIN, MILLER and NIES, Judges. MILLER, Judge. The decision of the Patent and Trademark Office ("PTO") Board of Appeals ("board") sustaining the rejection of claims 36-48[fn1] as unsupported by an adequate disclosure required by 35 U.S.C. § 112, first paragraph, is reversed. BACKGROUND Invention Appellant's invention relates to methods and devices for removing a hapten, antigen, or antibody from the blood of a living mammal. A hapten is a small molecule which does not by itself produce antibodies but which, when conjugated to a carrier protein or other macro-molecular carrier, induces in a recipient animal or human the production of antibodies that are specific to the small molecule. For example, certain psychoactive drugs, such as LSD, heroin, and tetrahydrocannabinol, can function as haptens. When an antibody (a relatively large immunoprotein) contacts the hapten or antigen to which it is specific, it tightly binds the hapten or antigen. It is this specific binding property of antibodies which is used by appellant to remove haptens, antibodies, or antigens from blood. Claim 44, the broadest appealed claim, from which claims 45 and 46 depend, reads:

An immunological method for removing from a living mammal a hapten in the blood of said mammal, comprising connecting in the blood circulatory system of said mammal a hapten-removing device, said device comprising passage means for said blood; an antibody to said hapten in said device; and exposure means in said device for exposing said hapten to said antibody and for preventing said antibody from entering said circulatory system.

Appealed method claims 36-39 involve linking to a matrix an antibody to a hapten and passing blood over the matrix. The antibody removes the hapten from the blood by binding the hapten.[fn2] Claim 40 is directed to a method for removing an antibody from the blood of a living mammal which is passed over an antigen linked to a matrix; claim 41 involves an antibody linked to a matrix to remove an antigen from blood. Claims 42 and 43 involve a method for removing a hapten or an antigen from blood through an immunodialysis process.[fn3] A semipermeable membrane, permeable to haptens or antigens and impermeable to antibodies, separates a patient's blood from a solution containing antibodies to the target molecules. Because the antibodies specifically bind target molecules that diffuse from the patient's blood through the semi-permeable membrane, a gradient across the membrane is present for the molecule, which continues to diffuse from the blood to the dialysis solution as long as the solution contains antibodies which are free to bind the target molecules. Claims 47 and 48 are essentially directed to devices for practicing claims 42 and 43. Proceedings Below The examiner rejected the claims as based upon an insufficient disclosure under 35 U.S.C. § 112, first paragraph, stating:


The disclosure is essentially an invitation to experiment. No specific examples are given. No human treatment (in fact no animal treatment) is described. The specification is replete with statements as to what may be done. No dialysis or adsorption data [have] been presented.

. . . . . . . [A]ppellant urges "nearly universal applicability" for selectively removing chemical species. If there is in fact universal applicability, with selectivity, appellant should have inserted numerous (50 to 100 for instance) examples into the specification. . . . . Appellant urges that no working example is required and that instructions to a technician are not required. But it has already been pointed out that appellant believes his device has universal applications (and the claims are just about that broad). Admittedly, one skilled in the art is a Ph.D., but even with such a high level of skill, such a person would need detailed guidance to practice the claimed alleged universal invention. The board took a somewhat different approach:

[A]ppellant admits . . . the disclosure contains no "operative example". While we recognize that specific examples are not necessary to meet the requirements of Section 112, In re Gay, 50 CCPA 725, 309 F.2d 769, 135 USPQ 311 (1962), when present, they do provide good evidence that the disclosure is enabling and that the invention may be performed without undue experimentation. In our view, the material most descriptive of the claimed methods and apparatus, is that presented in examples 12 and 13, wherein systems are defined for the removal of haptens, antigens and antibodies from the circulatory system. At best, the descriptive material is a generalized explanation of figures 6 and 7 in the drawings, and except for the regeneration step, provides no specific or even general guidelines for the treatment. The claimed methods . . . involve a complicated and complex series of reaction conditions that apparently require specifically related haptens, antigens and antibodies to operate effectively. We fail to find in the disclosure adequate instruction as to how these selections are to be made and in our view such selections would not be readily apparent or obvious to those of ordinary skill in the related art. Also required in various claims is the use of a matrix for use in binding the antibodies; however, we see no disclosure adequate to define such production or even the materials that are compatible in use. The specification also fails to teach or even suggest the antibodies or antigens that may be used with the appropriate haptens and we see no disclosure that would lead to or suggest a proper means of selecting the appropriate membranes for use in the removal devices. In short, it appears that the appellant has developed a concept of how a variety of prior art procedures may possibly be combined in a single method . . . and then retreated to leave those in the art with the task of experimentation to see if the method can be made to operate as set forth. . . . Here, appellant has presented no descriptive material that in our view is sufficient to provide a proper instruction in the manner of either developing the apparatus as claimed or the method of using same. The wide variety of variables that are inherent in the process, and for which the disclosure provides no basis for evaluation, leads us to the conclusion that operation of the method as claimed would involve an undue amount of experimentation and we will therefore sustain the rejection.

Thus, the board questioned whether the specification enabled selection and preparation of haptens, antigens, and antibodies; preparation of the matrix; selection of the dialysis membranes; and selection of parameters of the dialysis process. OPINION

Burden of Proof

A threshold issue is whether the PTO met its burden of proof in calling into question the enablement of appellant's disclosure. This burden required that the PTO advance acceptable reasoning inconsistent with enablement. Thereupon, the burden would shift to appellant to show that one of ordinary skill in the art could have practiced the claimed invention without undue experimentation. In re Sichert, 566 F.2d 1154, 1161, 196 USPQ 209, 215 (CCPA 1977).


The examiner reasoned that because of the breadth of the invention, a large number of examples (50 to 100) would be required to enable one of ordinary skill in the art to make and use the invention. 35 U.S.C. § 112, first paragraph. We recognize that working examples are desirable in complex technologies and that detailed examples can satisfy the statutory enablement requirement. Indeed, the inclusion of such examples here might well have avoided a lengthy and, no doubt, expensive appeal. Nevertheless, as acknowledged by the board, examples are not required to satisfy section 112, first paragraph. See, e.g., In re Stephens, 529 F.2d 1343, 188 USPQ 659 (CCPA 1976); In re Borkowski, 57 CCPA 946, 422 F.2d 904, 164 USPQ 642 (1970); In re Gay, 50 CCPA 725, 309 F.2d 769, 135 USPQ 311 (1962). Therefore, the examiner's statement that the "nearly universal applicability" alleged for the invention necessitated numerous examples was erroneous. Although the invention is applicable to a large variety of haptens and antigens, the examiner offered no reason why these different compounds would require different techniques or process parameters. However, the examiner (and the board) also reasoned that enablement was not present because no dialysis or adsorption (of the antibody or antigen to the matrix) data were presented, and we are persuaded that this was sufficient to shift the burden to appellant to establish that a person of ordinary skill in the art could have practiced the invention without undue experimentation. Enablement

The dispositive issue is whether appellant's disclosure, considering the level of ordinary skill in the art as of the date of appellant's application, would have enabled a person of such skill to make and use appellant's invention without undue experimentation. Appellant explains that his invention resides in combining the known prior art techniques of hemodialysis or hemoperfusion with immunochemical dialysis and immunochemical adsorption. He properly relies on literature citations to establish both the level of ordinary skill in the art and the fact that the techniques necessary to practice his invention were known in the art.[fn4] In re Eynde, 480 F.2d 1364, 178 USPQ 470 (CCPA 1973). A. Selection and Preparation of Haptens, Antigens, and Antibodies Appellant argues that methods for forming antibodies which are specific to particular haptens and antigens were well known prior to his filing date. In his specification, he states: Immunization of rabbits with conjugates in complete Freund's Adjuvant are carried out by a similar procedure to the one described by Strahilevitz et al, supra. The preparation of antisera and globulin fractions are also described in this reference. The antibodies may be purified by known methods such as those set out in Immunologic Methods in Steroid Determination. He then gives a specific example of preparing an antibody to tetrahydrocannabinol, referring to a method described in Immunologic Methods in Steroid Determination (Peron & Caldwell ed. 1970) for conjugating the compound to a protein, and detailing the injection of "[r]abbits, sheep or other suitable animals" with the conjugate, giving concentration, dosage, and frequency of injection data. Pinckard & Weir, Equilibrium Dialysis and Preparation of Hapten Conjugates in Handbook of Experimental Immunology 493 (D. Weir ed. 1967), cited in appellant's specification and made a part of the record in the parent application, details the preparation of protein-hapten conjugates, injection of the conjugates into animals, and recovery of antibodies to the haptens from the animals. It is clear from this disclosure that selection and preparation of related haptens, antigens, and antibodies involve routine and well-known techniques. Indeed, at oral argument, the Solicitor acknowledged that techniques for preparing antibodies to specific haptens and antigens were known in the art. B. Preparation of Matrix with Bound Antibodies In example 13 of appellant's specification, appears the following statement:


As shown in Figure 7, the apparatus for this method consists of a column 26 which includes a matrix 37 to which a binding species is linked. The binding species is a hapten, antigen (including a hapten conjugated to a carrier) or antibody which reacts specifically with the species which is to be removed from the blood. The linkage of the binding species to the matrix 37 may preferably be directly to the matrix, as when the matrix is made of a synthetic polymer such as polystyrenelatex. The linkage may also be through a suitable solid phase coating on the matrix. The antibody is then linked to the coating by one of the known methods for the preparation of immunoadsorbents, for example by a modification of one of the methods of Campbell (Campbell et al, Proc. Nat. Acad. Sci., U.S.A., 37, p. 575 (1951); Malley and Campbell, J. Am. Chem. Soc. 85, p. 487 (1963)). If any chance exists that the solid phase adsorbent may break loose from the matrix 37, suitable filters are necessary in the system. The matrix may simply be the wall of the (plastic) column if the length of the column is sufficient to provide the required surface area for interaction at the blood-binding species interface.

Additionally, appellant points out that appropriate matrices and techniques for binding antigens or antibodies thereto were well known in the art, as evidenced by Weetall, U.S. Patent No. 3,652,761, cited by the examiner in support of a rejection under 35 U.S.C. § 103 which was reversed by the board. Weetall discloses that it was known in the art to couple antigens to cellulose and its derivatives, polyaminopolystyrene, dextrans, and polyaminoacids to remove antibodies from serum. This patent also teaches a novel method for coupling antigens or antibodies to glass with the use of a silane coupling agent. C. Dialysis Membranes The position of the board and the Solicitor is that appellant has provided no disclosure regarding selection of the dialysis membranes required to practice the subject matter of claims 42, 43, 47, and 48. However, appellant's specification states: Such membranes, having various pore sizes, and thus which are permeable to molecules of various sizes are commercially available . . . . The semi-permeable membrane is chosen to be of such a porosity and permeability as to be permeable to small molecules like the intoxicating hapten of interest, but is not permeable to large molecules present in the blood of the patient such as serum proteins. Selection of the membranes, therefore, is based upon their porosity and the relative molecular sizes[fn5] of the antibody and the hapten or antigen. Weetall, supra, teaches that antigens generally have a molecular weight of 10,000 or higher, and that antibodies have molecular weights of 160,000 to 1,000,000. Haptens are much smaller.[fn6] Galletti et al., in U.S. Patent No. 3,619,423, disclose a process in which enzymes in a dialysis fluid remove undesirable substances from blood. The blood is separated from the dialysis fluid by a semipermeable membrane having a pore size which will pass compounds having a molecular weight of less than 10,000. The 100,000 molecular weight enzymes cannot cross the membrane. Thus, these references clearly indicate that selection of semipermeable membranes on the basis of pore size, as suggested by appellant's specification, was a technique known in the art prior to appellant's filing date. D. Dialysis Appellant states that a person of ordinary skill in the art would know appropriate flow rates and other parameters for performing dialysis, citing Galletti et al., supra, and Rosenbaum, Kramer, Raja, & Boreyko, Resin Hemoperfusion, 284 New England J. Med. 874 (1971). Galletti et al. teach a hemodialysis method which uses enzymes rather than antibodies to remove materials from blood. Dialysis parameters are disclosed, including a flow rate of 200 ml./min. Rosenbaum et al. teach a method in which blood is passed through a column at 300 ml./min. for three hours to remove barbiturates from the blood. These references disclose typical dialysis and related data in methods similar to those of appellant. There is no reason to believe that these parameters would not also be applicable to appellant's methods, as he contends. In view of all the foregoing, we hold that appellant's disclosure would have enabled a person of ordinary skill in the art to make and use appellant's invention without undue experimentation.[fn7]


The decision of the board is reversed. REVERSED. (3) changing the pH of said liquid phase in said third chamber for releasing said antibody from said hapten, and (4) returning said antibody to said second chamber and preventing said hapten from returning to said second chamber.

d. Written Description Requirement

• case: Vas-Cath Inc v. Mahhurkar

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS, EASTERN DIVISION

August 27, 1990

VAS-CATH INCORPORATED and GAMBRO, INC., Plaintiffs-Counterclaim Defendants, v.

SAKHARAM D. MAHURKAR and QUINTON INSTRUMENTS COMPANY, Defendants-Counterclaim Plaintiffs. SAKHARAM D. MAHURKAR and QUINTON INSTRUMENTS COMPANY, Counterclaim

Plaintiffs, v. GEOFFREY MARTIN, M. JANE MARTIN, and OMNI MEDICAL PRODUCTS INC., Counterclaim Defendants

The opinion of the court was delivered by: EASTERBROOK

FRANK H. EASTERBROOK, CIRCUIT JUDGE

Sakharam D. Mahurkar, a physician, holds several patents on dual-lumen hemodialysis catheters. A dual-lumen catheter is a pair of tubes (lumens) designed to allow blood to be removed from an artery, processed in a machine that removes impurities, and returned close to the place of removal.

Hemodialysis catheters are used to palliate kidney failure. In the event of chronic failure, physicians construct a fistula, a permanent internal connection between vein and artery that provides ready, long-term access to the circulatory system. During the several weeks required for the fistula to mature and heal, physicians need another entry point, which the catheter provides. In the event of acute failure, immediate access is essential, again via catheter.

Catheters cause trauma on insertion and while they remain. Every entry of a needle injures the blood vessel, the walls of which eventually collapse. The fewer entries, the better. The more comfort, the better. (Sometimes patients try to rip out catheters that aggravate them.) A catheter also should allow a high rate of flow without injury to the blood. Whirlpools, eddies, sharp edges, and collisions with rigid walls can rupture the red cells, which may lead to "hemolysis" (inability of the blood to carry sufficient oxygen) and to clotting. Either can cause brain damage or the death of the patient. Knowledge of fluid dynamics and the structure of the blood and vascular system is essential to design a catheter that can handle the necessary rate of flow at an acceptable rate of injury to the red cells.

Dual-lumen catheters allow the return and removal of blood with a single insertion. For years physicians used coaxial dual-lumen catheters. Blood leaves the body through the large outer tube and returns through the inner tube. In this cross-sectional diagram, the shaded area is the inner (return) tube, and the unshaded area the annulus through which blood is withdrawn. [SEE FIGURE 1 IN ORIGINAL]


The tip of the inner tube extends beyond the inlet, so that the cleansed blood is returned "downstream". Coaxial catheters usually were inserted surgically. Even so, inaccurate centering in the blood vessel could produce substantial damage to the blood, as could eddies that developed in the fluid motion.

The dual-lumen catheters covered by Dr. Mahurkar's patents take a different approach. Instead of concentric circles, they use joined semi-circular tubes, as the following figure shows. The shaded areas in this figure are the walls. [SEE FIGURE 2 IN ORIGINAL]

These tubes come to a single tip, a conic section with two openings. The opening at the tip (downstream) releases the cleansed blood; the other opening takes it in. Figure 3 shows illustrations of such a tip, from one of Dr. Mahurkar's patents. [SEE FIGURE 3 IN ORIGINAL]

Dual-lumen catheters of this construction may be inserted without surgery. Their small tip, coupled with the holes near the tip, allows physicians to use the "Seldinger technique": a wire guides the catheter into place. It may remain in place for weeks, so that one insertion is enough to complete the transition to the use of a fistula. The puncture area of a coaxial catheter is 42% greater than that of a semi-circular catheter carrying the same quantity of blood. And semi-circular designs with conical tips yield low rates of injury to the blood.

Catheters of this general construction are the medical community's first choice today for temporary access. Coaxial catheters are obsolete. Dr. Mahurkar's particular catheters have been successful, and they appear to represent more than half of the world's sales.

Vas-Cath Incorporated and its licensee Gambro, Inc. (the American subsidiary of Sopamed SA, the Swiss subsidiary of Gambro AB, a Swedish corporation), filed this suit seeking a declaratory judgment that their dual-lumen hemodialysis catheters do not infringe Dr. Mahurkar's U.S. patents. The complaint contends that (i) those patents are invalid, (ii) Geoffrey Martin, Vas-Cath's principal, is a co-inventor entitled to practice the patents, and (iii) the claims of the patents do not cover Vas-Cath's catheters. This suit is complex not only because of the many legal issues but also because Dr. Mahurkar holds numerous patents, and Vas-Cath's catheters have gone through two generations. Each generation of catheters must be assessed under each patent. As the case has proceeded, the Patent Office has issued some additional patents, which have been added to the litigation.

Mahurkar and his licensee Quinton Instruments Co. (a subsidiary of American Home Products Corp.) filed a counterclaim against Vas-Cath, contending that Vas-Cath's products infringe his patents. Mahurkar seeks an injunction and damages. Mahurkar brought into the suit Geoffrey Martin and his wife M. Jane Martin, as principals and stockholders of Vas-Cath, and Omni Medical Products Incorporated. The nature of the claims against these defendants is not important for current purposes. For simplicity, I call Mahurkar and Quinton "Mahurkar", and everyone else "Vas-Cath", except in Part III of this opinion when it becomes necessary to distinguish them.

Each side requests summary judgment. More precisely, each side requests summary judgment on particular counts and issues. All agree that summary judgment is not yet (and may never be) appropriate on all claims. The Rules of Civil Procedure do not expressly authorize motions for partial summary judgment. Nonetheless, the Manual for Complex Litigation § 21.34 (2d ed. 1985), recommends that judges pare off issues that may be resolved as a matter of law. The Advisory Committee on Civil Rules has recommended an amendment to Fed. R. Civ. P. 56 that if adopted would make official the practice of issuing legal rulings that dispose of issues but not the whole suit (or even entire claims). 127 F.R.D. 258, 370-85 (1989). The new caption of the rule conveys its scope: "Summary Establishment of Fact and Law; Summary Judgment". Both sides ask me to cut down the scope of this dispute, as if the proposal were already in force. I shall do so without attempting to resolve the suit, or particular counts, in full. After considering this opinion, the parties may propose an order that will put these rulings into effect.

I


Dr. Mahurkar's patents include Nos. 4,568,329 and 4,692,141. Vas-Cath asks me to declare these invalid under 35 U.S.C. § 102(b), contending that they were anticipated by Canadian Industrial Design No. 50089, which issued on August 9, 1982. The parties agree that this patent (Canadian '089) contains drawings identical, except for labels, to those underlying the U.S. '329 and '141 patents. No surprise, for Canadian '089 is also Dr. Mahurkar's patent.

An invention is unpatentable if it was "described in a printed publication in this or a foreign country . . . more than a year prior to the date of the application for patent in the United States". 35 U.S.C. § 102(b). Mahurkar applied for the '329 and '141 patents more than a year after August 9, 1982. Although it may seem odd that an inventor can be "anticipated" by his own work, the parties agree that Canadian '089 qualifies as a prior publication under § 102(b). Section 102(b) requires inventors to apply for U.S. patents with dispatch. They cannot lollygag while other persons start making an item and claim their patent at convenience, a maneuver that could both mousetrap business rivals and extend the effective life of the patent beyond 17 years.

Mahurkar does not deny that if the '329 and '141 patents take their own filing date, they are invalid. This outcome follows from his concession (for purposes of this motion) that Canadian '089 is enough to allow practice of the invention and therefore to anticipate the '329 and '141 patents. Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1574-75, 227 U.S.P.Q. (BNA) 177 (Fed. Cir. 1985). He submits, however, that they should be treated as if filed on March 8, 1982, when he applied for a U.S. design patent, Serial No. 356,081. Mahurkar abandoned serial '081 in 1984, after he applied for the utility patents that became '329 and '141. Because the drawing underlying serial '081 is functionally identical to Canadian '089 and illustrates the '329 and '141 patents, Mahurkar invokes 35 U.S.C. § 120, which gives an application the same filing date as "an application for patent for an invention disclosed in the manner provided by the first paragraph of section 112 in an application previously filed in the United States". Serial '081 qualifies under this language, Mahurkar submits, and so the '329 and '141 patents have filing dates before Canadian '089.

Vas-Cath meets this by contending that serial '081 does not satisfy the requirements of the first paragraph of § 112, which are:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

Conceding for purposes of this motion that the diagrams in serial '081 enable one skilled in the art to practice the invention, Vas-Cath nonetheless maintains that serial '081 does not contain a "written description of the invention". Indeed, it does not contain a writing, period. For it is a design patent, and under the Patent Office's rules applications for design patents need not contain written descriptions "other than a reference to the drawing". 37 C.F.R. § 1.153(a).

"Written" does not necessarily mean "using words". It could mean "committed to paper" or something similar. Writings are symbols conveying thoughts. Pictures and diagrams also are symbols conveying thoughts. So there is no sharp line between language and pictures. Recall that "a picture is worth 1,000 words." In re Berkman, 642 F.2d 427, 429, 209 U.S.P.Q. (BNA) 45 (CCPA 1981), holds that drawings may satisfy the disclosure requirement.

Vas-Cath's objection to the use of serial '081 is not so much the missing language as it is a contention that the diagrams in the design application do not describe the invention -- that is, the things that make the '329 and '141 patents distinctive. What matters, Vas-Cath insists, is that no words of limitation appear in serial '081 and no way to derive them. It shows a dual-lumen catheter, with D-shaped lumens and a conical tip. The tip has a distinctive cut, taper, and bevel, and holes obviously designed for use with the Seldinger technique. But it does not say what the invention consists in. Without words of limit, Vas-Cath insists, it is impossible to satisfy the first paragraph of § 112.


There are two ways out of this for Mahurkar. One is to establish that anything sufficient to allow reduction to practice is necessarily "a written description of the invention". If this is so, then Vas-Cath's concession that serial '081 allows practice -- essential to Vas-Cath's position that Canadian '089, with the same basic diagrams, anticipates the '329 and '141 patents -- is fatal. When Vas-Cath argues that Canadian '089 anticipates the '329 and '141 patents, it necessarily concedes that serial '081 discloses the invention, the argument concludes. The second way out is to demonstrate that the drawings in serial '081 do describe "the invention", as the ceramicdescribed in Kennecott Corp. v. Kyocera International, Inc., 835 F.2d 1419, 5 U.S.P.Q.2D (BNA) 1194 (Fed. Cir. 1987), revealed a crystal lattice by operation of the laws of physics. I discuss these in turn.

Decisions of the Federal Circuit control on the question whether something may allow the practice of an invention without automatically providing "a written description of the invention". Unfortunately, it is not so easy to tell what the law of the Federal Circuit is. In re Lukach, 58 C.C.P.A. 1233, 442 F.2d 967, 969-70, 169 U.S.P.Q. (BNA) 795 (1971), In re Barker, 559 F.2d 588, 591, 194 U.S.P.Q. (BNA) 470 (CCPA 1977), and In re Scheiber, 587 F.2d 59, 199 U.S.P.Q. (BNA) 782 (CCPA 1978), hold that the two are distinct. Paperless Accounting, Inc. v. Bay Area Rapid Transit System, 804 F.2d 659, 664-65, 231 U.S.P.Q. (BNA) 649 (Fed. Cir. 1986), pretty much merges the two. Then In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989), reiterates that they differ -- citing Lukach and not Paperless Accounting. You can draw from these cases almost anything you please, and the parties have done so. I do not think that I can resolve the question on the basis of precedent, or by claiming that the most recent word must be dispositive. It is better to start from scratch.

Section 112 says that the application must contain "a written description of the invention". It also says that the application must contain enough to allow practice. Separate statement of logically distinct requirements implies that there are indeed two elements. Sometimes a single disclosure may satisfy both; sometimes not. Words and pictures in conjunction (the stuff of patent applications) frequently will show the nature (and extent) of the invention as well as permit practice. Sometimes, as in Kennecott, a description of one feature of the invention will imply (and limit) others because the laws of physics allow only one possibility.

More commonly, however, a single diagram allows practice without showing "the invention". A diagram may show a dual-lumen catheter, with a given tip. Any competent professional could look at the diagram and the light would come on. The "Aha!" reaction would be followed by some simple steps to produce a workable catheter, just as blueprints enable the construction of buildings without verbal descriptions. Yet the information allowing practice would not necessarily show what the invention is, when "the invention" could be a subset or a superset of the features shown. Is the invention the semi-circular lumens? The conical tip? The ratio at which the tip tapers? The shape, size, and placement of the inlets and outlets? You can measure all of these things from the diagrams in serial '081 and so can practice the device, but you cannot tell, because serial '081 does not say, what combination of these things is "the invention", and what range of variation is allowed without exceeding the scope of the claims. To show one example of an invention, even a working model, is not to describe what is novel or important.

One could say -- perhaps the Federal Circuit eventually will say, picking up on Paperless Accounting -- that any filing establishing that the inventor's job was complete, and that only the scrivener's job remained, satisfies § 112. Viewed in retrospect, serial '081 shows this, and if this demonstration is enough then Mahurkar must prevail. Yet, in patent law, the translation from invention in a scientific sense to the legal description of the invention is important, because the law establishes a system of deadlines that could be subverted by allowing the scientific sense to control. Unless it conveys a sense of which features matter, a diagram could enable later filings on the entire genus of which it is a species, a process that would substantially enlarge the time for filing the real patent application. If a picture in Year 1 is to be the priority date for a dozen inventions more or less different years later, the timing rules would fall to pieces. These considerations lead me to conclude that Lukach and Gosteli state the law, that disclosure allowing practice does not necessarily describe "the invention".

This brings us to Mahurkar's second argument, that the diagrams in serial '081 satisfy the requirement that the application describe the invention. Whether it does is a question of fact, and Mahurkar offers the


affidavit of Mark Newman to the effect that the diagrams disclosed what was important. But the expert leaves out his process of reasoning, so the affidavit is entitled to little if any weight. Cable Electric Products, Inc. v. Genmark, Inc., 770 F.2d 1015, 1025-26, 226 U.S.P.Q. (BNA) 881 (Fed. Cir. 1985); Union Carbide Corp. v. American Can Co., 724 F.2d 1567, 1572, 220 U.S.P.Q. (BNA) 584 (Fed. Cir. 1984). See also Mid-State Fertilizer Co. v. Exchange National Bank, 877 F.2d 1333, 1338-40 (7th Cir. 1989); Kenosha Liquor Co. v. Heublein, Inc., 895 F.2d 418, 420 (7th Cir. 1990). With or without the affidavit, the record contains no disputed issue of material fact, so that summary judgment is appropriate. Although it has hinted that a diagram could satisfy the requirement that the application describe "the invention", KangaROOS U.S.A., Inc. v. Caldor, Inc., 778 F.2d 1571, 1574, 228 U.S.P.Q. (BNA) 32 (Fed. Cir. 1985), the Federal Circuit has never found one to be sufficient. This case would not be an auspicious beginning. Even giving the '329 and '141 patents the presumption of validity, 35 U.S.C. § 282, and applying the rule that a patent stands in the absence of "clear and convincing" absence of invalidity, as I have done, does not produce enough to support the conclusion that serial '081 satisfies the first paragraph of § 112. (There is, by the way, no evidence that the examiners on the the '329 and '141 patents considered this question.)

The drawings in serial '081 show cross-sections of a certain size, and openings a certain distance from the tip. But they do not require these features. Nothing in the laws of physics implies them. It may be that alterations would not work well, but this is a "utility" aspect that was not mentioned in the design patent. There were no clues in the design patent on how far if at all one could alter structure and still have the gist of this invention.

For example, the utility patents claim a return lumen that is "substantially greater than one-half but substantially less than a full diameter" after it makes the transition from semi-circular to circular cross-section, and the drawings of serial '081 fall in this range. But until the utility application was filed, nothing established that they had to -- for that matter that the utility patent would claim anything other than the precise ratio in the diagrams, or even that the utility application would claim that the ratio mattered (that it was part of "the invention"). The diagrams therefore could have been used to support a sequence of modifications, tearing up the time rules. The wide scope for elaboration on the theme of the diagrams in serial '081 prevents them from satisfying the initial requirement of § 112. When a description, written or otherwise, could imply one of many forms, disclosures have been held insufficient. E.g., In re Wright, 866 F.2d 422, 424, 9 U.S.P.Q.2D (BNA) 1649 (Fed. Cir. 1989); Titanium Metals Corp. v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985); In re Wilder, 736 F.2d 1516, 1520, 222 U.S.P.Q. (BNA) 369 (Fed. Cir. 1984).

Mahurkar replies with an affidavit by Dr. Stephen Ash concluding that someone expert in the field of hemodialysis catheters could have worked it out from the diagrams that the return (longer) lumen had to be less than 1.0 and greater than 0.5 the diameter of the tubing. This is logical, for a return lumen with a diameter as large as the entire catheter would produce a drop in pressure, with unhappy consequences, and unless the ratio exceeds 0.5 there is an increase in pressure. (Recall that this ratio applies after the cross-section has been converted to circular, below the intake.) Still, it is impossible to understand that Mahurkar believed that he had invented this ratio, or was claiming it, or if he was claiming it, within what range (" substantially greater than one-half but substantially less than a full diameter", as things turned out). Even this may be a mite fast. Later patents issued to Mahurkar disclose ratios closer to 1.0 (No. 4,583,968) and exactly 0.5 (No. DES 272,651). If these are do-able, even desirable, ratios -- at least when some other variations in the geometry accompany them -- how does serial '081 necessarily exclude then?

All in all, the best one can say is that what Mahurkar eventually patented is exactly what the pictures in serial '081 show. The utility patents contain the same diagrams. That cannot be sufficient, however, if the design application would have allowed variations -- that is, if the question be asked ex ante, as it should be. Moreover, although Mahurkar's patents use the same diagrams, they contain limitations that did not follow ineluctably from the diagrams.

Priority depends on a demonstration that the party has "possession of every feature" of the invention. Coleman v. Dines, 754 F.2d 353, 359, 224 U.S.P.Q. (BNA) 857 (Fed. Cir. 1985). We know in retrospect that Mahurkar was in possession of all the features, and that serial '081 shows an embodiment of them;


but it does not show which of the attributes are "the features", and how much variation in what is shown is allowable. Mahurkar's utility applications claimed the ratio of the return lumen's diameter to the catheter's. They might have claimed the distance between intake and outlet, or the shape of the inlet. They claimed neither. Nothing in serial '081 showed that the ratio of diameters was important, and the distance between intake and outlet irrelevant. If the applications for the '329 and '141 patents had contained the diagrams from serial '081 together with the single claim: "A dual-lumen catheter constructed like this", the examiner would have bounced the applications without much ado. For essentially the same reasons, I conclude that serial '081 does not satisfy the first paragraph of § 112.

Mahurkar emphasizes that in 1982 he was a practicing nephrologist, doing research on his own time and money. He filed a design application because it is a lot cheaper to prosecute than is a utility application. Since 1982 the value of his inventions has been recognized around the world, and he has acquired financial backing allowing him to perfect the utility applications and carry on with this costly litigation. His first filings now haunt him; his own invention is the "prior art" cited against him. In an ideal world, these facts might count for something. Still, one could reply that Mahurkar's first catheter went on the market in June 1983, less than a year after Canadian '089, and if the manufacturer (Quinton) thought it safe to rest with the design application, there should be no crocodile tears seven years later. At all events, the patent laws of the United States do not inquire into such matters. The '329 and '141 patents are invalid under § 102(b) because the applications were filed more than a year after the issuance of Canadian '089, and are not entitled to the filing date of serial '081.

II

Vas-Cath and Mahurkar are not strangers. They have been friends before, and adversaries before. In April 1981 Mahurkar sent Vas-Cath some double-D tubing with a request for help in "forming a smooth tip and bevel satisfactory for penetration test". Vas-Cath crafted some tips along lines Mahurkar suggested, and sent along at least two tips of its own design. Mahurkar contends that Vas-Cath stole his ideas when it began to market its own dual-lumen catheters. Vas-Cath contends that Mahurkar stole its ideas (demonstrated in the additional sample tips) when obtaining his patents.

This dispute led to patent litigation in Canada, Vas-Cath's base. Mahurkar sued Vas-Cath for infringing his Canadian patent No. 1,193,508. Vas-Cath defended on the usual grounds (obviousness, anticipation, non-infringement, and the like), adding the contention that Geoffrey Martin is the real inventor of the tip. After a trial on the merits, Justice Strayer of the Federal Court of Canada resolved almost every issue of fact and law in favor of Mahurkar, throwing Vas-Cath a bone by holding that several of the claims of Canadian '508 were too broad. Mahurkar v. Vas-Cath of Canada Ltd., [1988] 18 C.P.R.3d 417, affirmed, No. A-384-88 (Fed. Ct. App. Jan. 11, 1990).

Mahurkar's U.S. patent No. 4,583,968 covers the same invention as Canadian '508. He seeks summary judgment that Vas-Cath's first generation of catheters (the Vaccess 3500 and 4000 catheters) infringe the '968 patent, on the theory that the Canadian judgment precludes Vas-Cath from denying either the validity of the '968 patent or infringement by its catheters. Vas-Cath replies that the judgment concerning Canadian '508 has no force with respect to U.S. '968, but that, if it does, Vas-Cath is at least entitled to a declaration invalidating the American claims corresponding to the Canadian claims that Strayer J. found overbroad.

First in line comes the question whether principles of preclusion apply to foreign judgments concerning patents. Vas-Cath insists that they do not, on the ground that U.S. law differs from foreign law: both the substantive and procedural rules about patents vary from nation to nation, so that what is patented in Canada may be in the public domain here, and vice versa. To give preclusive effect to the Canadian judgment, Vas-Cath believes, would allow Canada to export its patent law to the United States. It musters an impressive array of precedent for the proposition that principles of claim preclusion (res judicata) do not carry across national borders in patent cases. E.g., Medtronic, Inc. v. Daig Corp., 789 F.2d 903, 907-08 (Fed. Cir. 1986); In re Dulberg, 472 F.2d 1394, 176 U.S.P.Q. (BNA) 525 (CCPA 1973); Skil Corp. v. Lucerne Products, Inc., 489 F. Supp. 1129, 1158 (N.D. Ohio 1980), affirmed, 684 F.2d 346, 351 n. 3 (6th Cir. 1982); Cuno Inc. v. Pall Corp., 729 F. Supp. 234 (E.D.N.Y. 1989).


To this Mahurkar replies that differences in law do not prevent enforcement of judgments from other jurisdictions. Although this proposition has overwhelming support, Restatement (3d) of Foreign Relations § 481, § 482(2) (1987), cf. Restatement (2d) of Judgments § 27 (1982), it is beside the point. No one thinks twice about enforcing in the United States a German court's judgment that a particular contract is valid and that the offender must pay damages, even though the Uniform Commercial Code is substantially different from the commercial law of Germany. We are not dealing with enforcement of a judgment. We are not even dealing with the judgment of a Canadian court that U.S. '968 is valid and infringed, so that claim preclusion might apply. We have instead a judgment that Canadian '508 is valid and infringed. The claims differ between the suits, and claim preclusion applies only to a claim that was or could have been prosecuted in the first action. Mahurkar did not contend, and could not have contended in the Canadian action, that Vas-Cath's products infringed the U.S. '968 patent.

Although a court may not say "Canadian '508 is valid and infringed, therefore U.S. '968 is valid and infringed", it is commonplace for courts in the United States to employ issue preclusion (collateral estoppel) even when claim preclusion is unavailable. E.g., Harris Trust & Savings Bank v. Ellis, 810 F.2d 700, 705-06 (7th Cir. 1987); Ackermann v. Levine, 788 F.2d 830, 844 (2d Cir. 1986). Patent litigation is costly, and the Canadian case was hard fought. Why begin from scratch? Conservation of resources is the principal objective of the law of preclusion, and that is a vital objective when costs are high, the more so when similar patents have been secured in many of the industrial countries. Patent litigation should not be allowed to become a war of attrition, in which after the conclusion of one battle parties move on to another and duplicate the engagement. If litigation squanders the returns to invention, we will have less innovation -- a depressing thought, given the importance of invention to economic growth. Whenever there is a choice, a court ought to opt for cost-saving and decision-expediting devices, of which preclusion is an attractive one. See generally Blonder-Tongue Laboratories, Inc. v. University of Illinois Foundation, 402 U.S. 313, 28 L. Ed. 2d 788, 91 S. Ct. 1434 (1971) (enlarging the scope of preclusion in patent cases).

Is there a choice? Judge Weinstein believes that the Federal Circuit is so hostile to preclusion in patent cases that a district court must decline to give effect to a foreign judgment even on questions of fact extensively litigated. Cuno, 729 F. Supp. at 238-39. This did not please Judge Weinstein, who remarked on "the law's absurdity as revealed by this case" -- not only compounding costs but also substituting the judgment of "American jurors with no background in science or patents, whose average formal education will be no more than high school", id. at 239, for the considered decisions of experts in the United Kingdom. I do not read the Federal Circuit's cases as compelling courts of the United States to ignore informed decisions rendered abroad; the judges of that distinguished court are not xenophobes. Decisions from the Federal Circuit instead reflect the legitimate concern that, when considering what the first case settled, courts not disregard differences in law. If a foreign court renders judgment on a question of fact with significance in each system of law, there is no reason not to take over that decision. Despite Judge Weinstein's omens, I propose to do just that: to examine the Canadian judgments, to learn what has been decided, and to apply those decisions to this litigation to the extent -- and only to the extent -- they are legally relevant, and the findings are free of the influence of legal differences.

Before I turn to this task, however, three more possibilities need attention. One is that Canadian law supplies the rule of preclusion, the second that the Canadian proceedings are unreliable, and the third that the presumption of validity accorded to U.S. patents colors the appreciation of foreign decisions. Start with the first. Federal courts in the United States must use the rules of the rendering court when deciding the preclusive effect of state judgments, even when the judgment affects a subject within the exclusive jurisdiction of the federal courts. 28 U.S.C. § 1738; Marrese v. American Academy of Orthopaedic Surgeons, 470 U.S. 373, 84 L. Ed. 2d 274, 105 S. Ct. 1327 (1985). Section 1738 refers only to state judgments, however, which means that federal common law supplies the rules of preclusion.

Vas-Cath asks me to apply Canadian law as a matter of comity, and it argues that Canada would allow it to bring a sequential "impeachment" action against Mahurkar's patent. Mahurkar maintains that Vas-Cath had its opportunity at impeachment as part of its defense against Mahurkar's suit. I do not think it necessary to decide who is right. When deciding the force to be given to foreign judgments, the Federal Circuit has crafted its own common law, without reference to the rules of preclusion applied in the


rendering nations. Cf. Robert C. Casad, Issue Preclusion & Foreign Country Judgments: Whose Law ?, 70 Iowa L. Rev. 53 (1984). This means that I need not settle this debate between the parties. At all events, Canada applies the broad, British version of issue preclusion, see Restatement (3d) of Foreign Relations § 481 note 6(b) (summary of approach of foreign nations). As I do not venture beyond issue preclusion, arguments about the extent of claim preclusion in Canada and the obligations of comity need not cause concern.

Similarly, I do not think it important that Canada does not afford parties the same discovery rights as the Federal Rules of Civil Procedure. Preclusion survives substantial differences in the rules of procedure (provided the differences are not so great that the original judgment was obtained without due process of law, as we understand that phrase). Even within the United States, some states are more stingy with discovery than are federal courts, yet their judgments are honored. Vas-Cath does not contend that the system of litigation in Canada is uncivilized or unlikely to produce sound judgments. Most nations of the world view our system of discovery as uncivilized. No case I could find declined to give force to a Canadian judgment on the ground that Canadian procedural rules differ from ours. Vas-Cath has not pointed to any fact that it wanted to bring to the Canadian court's attention but could not because of procedural rules. Even after extensive discovery in this case, Vas-Cath has not identified any fact that could have made a difference, if only it had been found in time for presentation to the Canadian court.

As for the presumption of validity: this is a rule of law, not a filter through which to understand findings of fact. If foreign findings are colored by a foreign presumption against patents, or if the findings were rendered under a different burden of proof, these might prevent application in U.S. litigation. In the main, however, the Canadian judgment supports the validity of the patents; the presumption of validity reinforces rather than undercuts their force. The judgment of the Federal Court of Canada accordingly receives the same weight it would have if it had been rendered by a federal court in the United States.

A

Strayer J. concluded that Mahurkar and not Geoffrey Martin invented the tip covered by Canadian '508. 18 C.P.R.3d 425-30. Strayer J. found that Mahurkar devised the basic idea for his catheters during summer 1979 and developed a tapered tip by January 1981, before sending anything to Vas-Cath. He also concluded, id. at 426, that Quinton and not Vas-Cath developed Mahurkar's designs into a commercially acceptable catheter. In reaching these conclusions, Strayer J. relied on the credibility of the witnesses and their ability to do what they said they did:

I have preferred the evidence of the plaintiff to that of Mr. Martin on behalf of Vas-Cath. . . . [No evidence support's Martin's claims concerning the dates of his work.] Nor was there any evidence that he developed this design into a workable product until after the Mahurkar catheter was actually on the market. I am further inclined to believe that Dr. Mahurkar was the inventor rather than Mr. Martin because Dr. Mahurkar had the requisite skills to create an appropriate design and Mr. Martin did not. In expert evidence given by both Dr. Mahurkar and Dr. Uldall it was said that the design of such a catheter requires extensive medical knowledge, particularly that related to the behavior of blood, as well as knowledge of the technology of hypodermic needle and catheter manufacture. Dr. Mahurkar's training and experiences equipped him for this task. By contrast, Mr. Martin's academic training is in music. . . . While he no doubt has developed a certain amount of technical skill in the manufacture of catheters I have concluded, from the foregoing and other evidence, that with respect to this catheter he was more opportunist than inventor.

Vas-Cath did not pursue this issue on appeal in Canada.

This factual finding is as relevant to the inventorship of U.S. '968 as it is to Canadian '508. Who is the inventor and who the copier is a staple question in any patent system, and the Canadian decision did not depend on any features of Canadian law not shared by U.S. law. It is a decision of fact, reached after full and fair litigation.


Mahurkar is not satisfied with victory on the '968 patent; he wants a decision that Martin contributed nothing. Vas-Cath insists that even if Mahurkar was the sole inventor of the '508/'968 subject matter, it is still entitled to credit for (or shop rights in) the U.S. '329 and '141 patents and DES '651, which Vas-Cath insists derive from the sample tips Martin devised in 1981. The Canadian judgment did not mention these tips; Mahurkar believes that the omission was natural, because Strayer J. thought Martin incapable of making such a contribution. There is, however, another reason for the omission: Vas-Cath sent Mahurkar these tips after the date of invention relevant for Canadian purposes. Issue preclusion applies only to issues actually and necessarily decided. Strayer J. did not decide the provenance of Mahurkar's other tips. Consequently, Vas-Cath is not precluded from arguing that tips Mahurkar devised after receiving the samples from Vas-Cath were derived from those samples. Mahurkar may contend that because he had hired Vas-Cath to work for him, he is entitled to the benefit of those tips. Nonetheless, there is no need to proceed along these lines. As I have declared the '329 and '141 patents invalid, the origin of their tips is immaterial. Vas-Cath may still wish to argue that the tip in DES '651 derives from these samples. From what I have seen of the tips, it is not apt to get far (the designs are quite different), and a motion for summary judgment might put any remaining issue of inventorship to rest. Nonetheless, it should be clear that the only question covered by issue preclusion is who invented the subject matter of the U.S. '968 patent.

B

Vas-Cath argues that Canadian '508 was anticipated by prior art. Strayer J. fully considered this contention, particularly the reference to Pfarre 1882, and concluded that the design is original with Mahurkar. 18 C.P.R.3d at 430-32. Again this seems to be a question on which differences in the legal system do not matter.

Vas-Cath identifies two potential differences. One need not detain us. In considering the Pfarre reference, the Canadian judge remarked that Pfarre's designs had not been reduced to practice and that a person skilled in the art would not have been aware of Pfarre's invention. Both of these are relevant in Canadian law. 18 C.P.R.3d at 430. The former is irrelevant in the United States, which also imputes to experts awareness of prior art. All the same, a fair reading of Strayer J.'s findings shows that neither of these was important. Pfarre invented an enema tube for use in cattle. As my Canadian colleague writes, Pfarre "describes a catheter of soft rubber rounded, not tapered, at the end. It has within it two channels or lumens which are not of similar size. . . . The Pfarre patent says nothing of the importance of having two D-shaped lumens of equal size." 18 C.P.R.3d at 430. Enema tubes for washing parts of the body are not designed to minimize the injury to blood cells. The inventions are sufficiently different that I would be willing to declare as a matter of law that Pfarre does not anticipate the '968 patent. I need not, because after listening to expert opinion Strayer J. reached exactly that conclusion, which I deem preclusive against Vas-Cath.

The second, and most important, difference is that the timing rules of the patent laws set different cutoff dates for looking at prior art. Canada cuts off references to the prior art as of the date of the invention, which Strayer J. found to be January 1981. American law takes note of prior references up to one year before the filing date of the application -- a difference that dooms Mahurkar's '329 and '141 patents. Mahurkar filed the application that matured into the '968 patent on August 15, 1984. He claimed the benefit of the filing date of serial No. 538,671, an application for a design patent filed on October 3, 1983. The parties have not (yet) asked me to decide whether Mahurkar obtains the benefit of that filing date. If he does, then prior art references between January 1981 and October 3, 1982, remain to be considered; if he does not, then references between January 1981 and August 15, 1983, must be considered.

At oral argument I asked whether there are significant references in these periods. Vas-Cath replied that Canadian '089 (Mahurkar's own design again!) falls in the gap and suggested that two U.S. patent applications filed in 1981 are significant. The priority date of the application for the '968 patent also may matter because of the "on sale" bar in 35 U.S.C. § 102(b): no patent may issue if the application was filed more than a year after the invention was "in public use or on sale in this country". Quinton started selling one of Mahurkar's catheters in June 1983. If the '968 patent takes August 15, 1984, as its filing date, these sales may be significant. Moreover, Quinton furnished samples of the catheter to the Northwest


Kidney Center in Seattle in August 1982, which poses a difficulty for the '968 patent no matter which filing date obtains.

So far neither side has asked me to determine (a) which filing date applies to the '968 patent, (b) whether references between January 1981 and the year before the filing date of the '968 patent (whatever that turns out to be) anticipate it, or (c) whether either the sales in June 1983 or the samples in August 1982 activate the "on sale" bar. Envirotech Corp. v. Westech Engineering Inc., 904 F.2d 1571, 15 U.S.P.Q.2D (BNA) 1230 (Fed. Cir. 1990), doubtless sheds some light on the latter question, holding that a product is not "on sale" unless made widely available. I mention these potential difficulties only to show that they lie ahead.

In a case this complex, it pays to reduce the number of open issues even if some remain for future decision. One issue that can be sliced off is whether references in the prior art before January 1981 anticipate the '968 patent. I hold, on the basis of the Canadian decision, that they do not.

C

According to Vas-Cath, Canadian '508 is obvious to one skilled in the art. This became a principal subject of the trial, and the Canadian judge made extensive findings. 18 C.P.R.3d at 432-46. Mahurkar won a smashing victory. Strayer J. reached this decision because (a) there was a recognized problem and unmet need, suggesting that those skilled in the art did not find the solution obvious; (b) Dr. Robert Uldall, a witness taken as a paradigm skilled practitioner, not only did not know how to solve the problem but also thought initially that the Mahurkar solution would not work; and (c) Mahurkar's solution swept the market, which implies an advance beyond others skilled in the art. If the rewards were as large as Mahurkar's success shows, then someone else would have had ample motive to find an "obvious" answer. The Federal Court of Appeal considered and rejected Vas-Cath's objections to these conclusions. All of the judge's reasons are as appropriate to decision under U.S. law as they were under Canadian law.

Canadian and American standards on obviousness are identical in all significant respects but one: the United States presumes that practitioners know the prior art, Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962, 1 U.S.P.Q.2D (BNA) 1196 (Fed. Cir. 1986); In re Nilssen, 851 F.2d 1401, 1403, 7 U.S.P.Q.2D (BNA) 1500 (Fed. Cir. 1988), and Canada apparently does not. Beloit Canada Ltd. v. Valmet Oy, [1986] 8 C.P.R.3d 289, 297 (Fed. Ct. App.). This distinction does not make a difference, because Strayer J. relied on the fact that even the most skilled practitioners at the time, witnesses Uldall and Dr. Stanley Shaldon, who were acutely aware of the prior art, did not find Mahurkar's solution obvious. Vas-Cath offers no reason to disregard that decision. Accordingly, I conclude that as between Mahurkar and Vas-Cath, the '968 patent is not obvious.

Questions remain about whether something coming to light between January 1981 and the priority date of the '968 patent could establish obviousness. Strayer J. disregarded all references after January 1981, see 18 C.P.R.3d at 435. So far as I can see, however, nothing cited in that period would have an effect on obviousness distinct from its effect on anticipation. It therefore makes sense to remove obviousness from the case as a separate issue with respect to the '968 patent, and focus attention on any intervening references under the rubric of anticipation.

D

Next comes the question whether the specifications in the patent are sufficient to allow one skilled in the art to practice the invention. Justice Strayer concluded that the specifications in Canadian '508 meet that test. 18 C.P.R.3d 436-42.

Canada asks whether the specifications in the patent as issued enable reduction to practice. See § 36(1) of Canada's Patent Act. The United States asks whether the information in the application as filed satisfies § 112. W.L. Gore & Associates v. Garlock Inc., 721 F.2d 1540, 1556, 220 U.S.P.Q. (BNA) 303 (Fed. Cir. 1983). We do not yet know what disclosures Mahurkar made as of the date of filing the U.S. patent


application, because we do not yet know which date Mahurkar will obtain -- that of the design patent application in 1983, or the utility patent application in 1984.

As a practical matter, this means that the Canadian judgment is not preclusive on the sufficiency of disclosure if Mahurkar needs and obtains priority from the design application in 1983. If on the other hand Mahurkar accepts the 1984 priority date of the utility patent application, the Canadian judgment is preclusive. The only differences between the Canadian patent issued in 1985 and the U.S. application filed in 1984 have to do with four elements of Claims 1 and 7 (parallel to but slightly narrower than the Claims 1 and 5 in the Canadian patent). My reading of the documents and examination of the diagrams leads to the conclusion that the differences make explicit what was implicit in the Canadian papers. Because claims must be read in light of specifications, D.M.I., Inc. v. Deere & Co., 755 F.2d 1570, 1574 n. 2, 225 U.S.P.Q. (BNA) 236 (Fed. Cir. 1985), I conclude that the changes do not affect the judgment on sufficiency of disclosure.

In sum, if Mahurkar obtains the 1983 date of the design application, the Canadian judgment is not preclusive; if Mahurkar takes the 1984 date of the utility application, the Canadian judgment is preclusive on sufficiency. Which date is the right one remains an open question.

E

Claims 1-6, 8-10, 12-13, 17, and 21-25 of Canadian '508 were held invalid because they claimed more than the invention actually described. 18 C.P.R.3d at 442-44. Strayer J. concluded that the "invention" in Canadian '508 has four essential features: (1) twin lumens, each semi-circular (D-shaped); (2) one lumen shorter; (3) a conical tapered tip at the distal end, with extra material for rigidity; and (4) a tip guidance point at the center of the conical tip. Claims asserting more were held overbroad because they do not disclose anything (as opposed to lay claim to it). Mahurkar says that Canadian '508 is essentially identical to U.S. '968. It ought to follow that the parallel claims of U.S. '968 are invalid too, if the law is the same. And it is. Although the United States does not use the word "overbreadth", the fundamental concept applies under § 112. In re Borkowski, 57 C.C.P.A. 946, 422 F.2d 904, 909, 164 U.S.P.Q. (BNA) 642 (1970); In re Hyatt, 708 F.2d 712, 714, 218 U.S.P.Q. (BNA) 195 (Fed. Cir. 1983).

Vas-Cath demands the benefit of the favorable portion of the Canadian judgment if Mahurkar has the benefit of the portions favorable to him. Mahurkar tries to avoid this on three grounds: the presumption of validity for U.S. patents; a difference in the burden of proof imposed on the party attacking the patent (preponderance in Canada, "clear and convincing evidence" in the United States); and a difference in Claim 1 of the U.S. '968 patent.

Burdens and presumptions fall away because interpretation and scope of a claim are legal issues in the United States. E.g., Corning Glass Works v. Sumitomo Electric U.S.A., Inc., 868 F.2d 1251, 1256, 9 U.S.P.Q.2D (BNA) 1962 (Fed. Cir. 1989); Moleculon Research Corp. v. CBS Inc., 793 F.2d 1261, 1270, 229 U.S.P.Q. (BNA) 805 (Fed. Cir. 1986). "Clear and convincing" is a standard by which to assess the sufficiency of factual evidence, Raytheon Co. v. Roper Corp., 724 F.2d 951, 956, 220 U.S.P.Q. (BNA) 592 (Fed. Cir. 1983); SSIH Equipment S.A. v. ITC, 718 F.2d 365, 375 (Fed. Cir. 1983), and the question at hand does not depend on resolving factual conflicts or weighing evidence. The presumption of validity is a tie-breaker, a solution if all is in equipoise, and again the concept does not apply to a legal argument.

I am inclined to believe that he who lives by the sword must be prepared to die by the sword. Mahurkar has convinced me to apply rules of preclusion. Sometimes he gains, sometimes he loses. Despite this inclination, however, I am uncomfortable about treating the decision as preclusive because it is one of "law". Vas-Cath escaped the effect of the different burdens of persuasion -- which usually defeat issue preclusion -- by showing that the interpretation and validity of claims is a question of law. Usually that also means that claim preclusion does not apply. I therefore do not come to rest on this subject. As part of their next wave of motions, the parties should address the question whether preclusion applies to this "legal" aspect of the Canadian judgment.

F


Where does all this leave us? These issues remain to be decided concerning the '968 patent:

1. First, because it affects almost everything else, to what filing date is the '968 patent entitled?

2. Do samples or sales before that filing date (to the Northwest Kidney Center in August 1982 and more widely in June 1983) activate the "on sale" bar of § 102(b)?

3. Do disclosures after January 1981 but more than a year before the filing date anticipate the '968 patent?

4. Are the claims of the '968 patent parallel to Claims 1-6, 8-10, 12-13, 17, and 21-25 of Canadian '508 excessive in relation to the invention disclosed?

5. Do Vas-Cath's products infringe the '968 patent?

At least the first three of these questions must be decided without assistance from the Canadian judgment. The effect of that judgment on questions 4 and 5 remains in limbo. It is not clear that No. 5 is even disputed for the first generation of Vas-Cath's catheters, if the '968 patent is valid.

Patent DES '651 presents a sixth issue: Martin's role in the design of the tip. On this subject, for reasons I have explained, there is no preclusion, but I do not rule out future decision as a matter of law on any questions concerning this patent. Some briefs on shop rights have been tendered, but I defer any decision until the parties have had an opportunity to make arguments based on this decision.

III

Gambro, Inc. (Gambro US), one of the plaintiffs in this case, was not a party to the Canadian litigation. It insists that it is free to litigate from scratch even if Vas-Cath is precluded. Mahurkar asks me to hold that Gambro US is bound by the Canadian judgment to the same extent as Vas-Cath. Gambro Canada Ltd. was aligned with Vas-Cath in the Canadian action. Gambro Canada is a subsidiary of Gambro Lundia AB, a subsidiary of Gambro AB (Gambro Sweden). Gambro US likewise is an indirectly held subsidiary of Gambro Sweden. Mahurkar believes that Gambro US received "virtual representation" in Canada through the offices of Gambro Canada; Gambro US submits that it is independent of Gambro Canada in management, operation, and finance, and therefore is entitled to litigate the question for itself.

"Virtual representation" is a doctrine allowing the preclusion of parties not present in the first case, provided that someone who was present had the same interests as the absent party and so had every reason to prosecute or defend the case as vigorously. E.g., Benson & Ford, Inc. v. Wanda Petroleum Co., 833 F.2d 1172 (5th Cir. 1987); Mother's Restaurant, Inc. v. Mama's Pizza, Inc., 723 F.2d 1566, 1572-73, 221 U.S.P.Q. (BNA) 394 (Fed. Cir. 1983). Judicial resources are scarce, and if the first litigation was as complete as the extra party could have made it, had it been present, why not accept the outcome? This is what courts do all the time in class actions, in which the representative member of the class supplies virtual representation to the missing members; as a practical matter, it is what happens in many cases even when the party nominally appears -- a lawyer makes all the important decisions.

Notwithstanding the attractions of the doctrine, the idea that someone may be bound by the results of a case even though he did not participate is in tension with the autonomy recognized in our legal system. It amounts to saying that intervention is compulsory, that if a pending case affects your interests you must intervene in it, because you will be bound whether you intervene or not -- at least if someone already there is "on your side" (that is, offers "virtual representation"). Yet the rules of intervention under Fed. R. Civ. P. 24 run the opposite way: if a party in the case represents your interests, the court is unlikely to allow intervention. The upshot is that when representation is "virtual" it may also be exclusive: the existence of a "virtual representative" will prevent you from intervening to protect your own interests.


All of this is in sharp conflict with the principles that an entity is not bound by the decision of a case in which it could not participate, and that no one is obliged to intervene. The onus, rather, is on the adverse party to join anyone it would like to have bound. If "virtual representation" is enough to bind a party, then Martin v. Wilks, 490 U.S. 755, 109 S. Ct. 2180, 104 L. Ed. 2d 835 (1989), should have come out the other way: the court should have held that a consent decree binds anyone who could have intervened but did not. Martin concluded, however, that persons affected by a decree to which they were not parties may attack it collaterally, because judicial decrees do not bind non-parties.

Class actions do not offend accepted principles in the same way "virtual representation" does. A member of a class under Fed. R. Civ. P. 23(b)(3) may opt out. (Classes under Rule 23(b)(1) and (2) do not allow opting out, but in such injunctive cases there will be only one outcome without regard to concepts of "representation.") A member of the class who opts out may litigate independently, and is not bound by an adverse judgment in the main action -- and correspondingly may not take the benefit of a favorable one, "virtual representation" by the class representative notwithstanding. Premier Electrical Construction Co. v. National Electrical Contractors Ass'n, Inc.,814 F.2d 358, 361-67 (7th Cir. 1987). See also Colby v. J.C. Penney Co., 811 F.2d 1119, 1125 (7th Cir. 1987), and Secretary of Labor v. Fitzsimmons, 805 F.2d 682, 692-94 (7th Cir. 1986) (in banc), both expressing doubts about "virtual representation".

A venerable rule makes it unnecessary to decide whether to embrace the doctrine of "virtual representation". Preclusion applies to the parties and those in privity with them. Legal rulings may affect a subject such as a contract or patent, and the holder of the patent may not have another go at litigation by issuing a new license. The licensee takes the patent encumbered, as it were, with the decision affecting its validity. So the right question is not whether Gambro US is the an alter ego of (or was "virtually represented" by) Gambro Canada. It is whether Gambro US, as Vas-Cath's licensee, is in privity of contract with Vas-Cath. If it is, the jig is up. Montana v. United States, 440 U.S. 147, 59 L. Ed. 2d 210, 99 S. Ct. 970 (1979).

Technically Gambro US is not in privity with Vas-Cath, which licensed Gambro Sweden, not Gambro US or Gambro Canada. Gambro Sweden decided (through Gambro Lundia and Gambro Switzerland) that Gambro US would hold rights to Vas-Cath's products in the United States, and Gambro Canada would hold rights to them in the rest of the world. Gambro Sweden is in privity of contract with Vas-Cath, and I cannot see why Gambro Sweden should be entitled to receive two or more adjudications on the validity of Mahurkar's patents and whether Vas-Cath's products infringe them, just because Gambro Sweden carved up the world into two or more territories with two or more subsidiaries.

Is a parent corporation bound by adjudications in which its subsidiaries participate? Again in a technical sense the answer is no, for the subsidiary has a separate legal personality. Gambro Sweden cannot be called on to pay the debts of Gambro US or Gambro Canada. All the same, the parent is in a position to control the litigation if it chooses. Franchise Tax Board of California v. Alcan Aluminium Ltd., 493 U.S. 331, 107 L. Ed. 2d 696, 110 S. Ct. 661, 666 (1990), holds that a foreign parent's ability to direct the litigation of its subsidiary in the United States is enough to require it to abide the results. Powers to control justified preclusion in Alcan and Montana ; they do so here as well. Because Gambro Sweden, as licensee of Vas-Cath with the power to control Gambro Canada, is bound by the Canadian judgment, its sub-licensee Gambro US is bound. I hold that Gambro US is precluded by the Canadian judgment to the same extent as Vas-Cath.

IV

The papers filed in this case already threaten to overrun my chambers. Today's opinion makes a dent in the issues, but as Part II.F demonstrates many could not be resolved. Other patents and new Vas-Cath products have not even been mentioned. The Martins have filed two motions that are being briefed. Three more suits concerning Mahurkar's patents are pending. One has been transferred to the Northern District of Illinois under 28 U.S.C. § 1404(a), and the Judicial Panel on Multidistrict Litigation is contemplating whether to consolidate the others for pretrial proceedings. I hope that this opinion will narrow the differences between the parties and facilitate more concise motions and briefs directed to the remaining disputes.


e. Limitations on Amendments SEC. 49, IP Code Amendment of Application. – An applicant may amend the patent application during examination: Provided, That such amendment shall not include new matter outside the scope of the disclosure contained in the application as filed. (n)

• case: The Gentry Gallery Inc. v. The Berkline Corp

NOS. 97-1076, 97-1104 AND 97-1182.

134 F.3d 1473 (1998)

The GENTRY GALLERY, INC., Plaintiff-Appellant,

v.

The BERKLINE CORPORATION, Defendant/Cross-Appellant.

United States Court of Appeals, Federal Circuit.

January 27, 1998.

Rehearing Denied; Suggestion For Rehearing Declined April 3, 1998.

James J. Foster, Wolf, Greenfield & Sacks, P.C., Boston, MA, argued for plaintiff-appellant. With him on the brief was Douglas R. Wolf.

Ronald L. Engel, Rudnick & Wolfe, Chicago, IL, argued for defendant-cross appellant. With him on the brief was Richard A. Machonkin. Of counsel on the brief was David D. Kaufman, Hamman & Benn, Chicago, IL.

Before RICH, Circuit Judge, FRIEDMAN, Senior Circuit Judge, and LOURIE, Circuit Judge.

Rehearing Denied; Suggestion For Rehearing In Banc Declined April 3, 1998.

LOURIE, Circuit Judge.

The Gentry Gallery appeals from the judgment of the United States District Court for the District of Massachusetts holding that the Berkline Corporation does not infringe U.S. Patent 5,064,244, and declining to award attorney fees for Gentry's defense to Berkline's assertion that the patent was unenforceable. See Gentry Gallery, Inc. v. Berkline Corp., 30 USPQ2d 1132, 1994 WL 171795 (D.Mass.1994) (Gentry I). Berkline cross-appeals from the decision that the patent was not shown to be invalid. See Gentry Gallery, Inc. v. Berkline Corp., 939 F.Supp. 98, 41 USPQ2d 1345 (D.Mass.1996) (Gentry II). Because the court correctly concluded that the claims were not infringed by Berkline, and that the subject matter of the asserted claims was not shown to have been obvious, and did not abuse its discretion in declining to award attorney fees, we affirm these decisions. However, because the court clearly erred in finding that the written description portion of the specification supported certain of the broader claims asserted by Gentry, we reverse the decision that those claims are not invalid under 35 U.S.C. § 112, ¶ 1 (1994).

BACKGROUND

Gentry owns the "244 patent, which is directed to a unit of a sectional sofa in which two independent reclining seats ("recliners") face in the same direction. Sectional sofas are typically organized in an L-shape with "arms" at the exposed ends of the linear sections. According to the patent specification, because recliners usually have had adjustment controls on their arms, sectional sofas were able to contain two recliners only if they were located at the exposed ends of the linear sections. Due to the typical L-shaped configuration of sectional sofas, the recliners therefore faced in different directions. See `244


patent; col. 1, ll. 15-19. Such an arrangement was "not usually comfortable when the occupants are watching television because one or both occupants must turn their heads to watch the same [television] set. Furthermore, the separation of the two reclining seats at opposite ends of a sectional sofa is not comfortable or conducive to intimate conversation." Id. at col. 1, ll. 19-25.

The invention of the patent solved this supposed dilemma by, inter alia, placing a "console" between two recliners which face in the same direction. This console "accommodates the controls for both reclining seats," thus eliminating the need to position each recliner at an exposed end of a linear section. Id. at col. 1, ll. 36-37. Accordingly, both recliners can then be located on the same linear section allowing two people to recline while watching television and facing in the same direction. Claim 1, which is the broadest claim of the patent, reads in relevant part:

A sectional sofa comprising:

a pair of reclining seats disposed in parallel relationship with one another in a double reclining seat sectional sofa section being without an arm at one end ...,

each of said reclining seats having a backrest and seat cushions and movable between upright and reclined positions ...,

a fixed console disposed in the double reclining seat sofa section between the pair of reclining seats and with the console and reclining seats together comprising a unitary structure,

said console including an armrest portion for each of the reclining seats; said arm rests remaining fixed when the reclining seats move from one to another of their positions,

and a pair of control means, one for each reclining seat; mounted on the double reclining seat sofa section....

Id. at col. 4, line 68 to col. 5, ll. 1-27 (emphasis added to most relevant claim language). Claims 9, 10, 12-15, and 19-21 are directed to a sectional sofa in which the control means are specifically located on the console.

In 1991, Gentry filed suit in the District Court for the District of Massachusetts alleging that Berkline infringed the patent by manufacturing and selling sectional sofas having two recliners facing in the same direction. In the allegedly infringing sofas, the recliners were separated by a seat which has a back cushion that may be pivoted down onto the seat, so that the seat back may serve as a tabletop between the recliners. In response to Gentry's complaint, Berkline moved and was granted a transfer to the District of Massachusetts of its earlier-filed action in the United States District Court for the Middle District of North Carolina seeking a declaration that the patent was invalid and not infringed. After that declaratory judgment action was consolidated with Gentry's infringement suit, Berkline added a counterclaim asserting that the patent was unenforceable because of inequitable conduct. The district court granted Berkline's motion for summary judgment of non-infringement, but denied its motions for summary judgment of invalidity and unenforceability. In construing the language "fixed console," the court relied on, inter alia, a statement made by the inventor named in the patent, James Sproule, in a Petition to Make Special (PTMS). See 37 C.F.R. § 1.102 (1997). Sproule had attempted to distinguish his invention from a prior art reference by arguing that that reference, U.S. Patent 3,877,747 to Brennan et al. ("Brennan"), "shows a complete center seat with a tray in its back." Gentry I, 30 USPQ2d at 1137. Based on Sproule's argument, the court concluded that, as a matter of law, Berkline's sofas "contain[] a drop-down tray identical to the one employed by the Brennan product" and therefore did not have a "fixed console" and did not literally infringe the patent. Id. The court held that Gentry was also "precluded from recovery" under the doctrine of equivalents.

Gentry then requested that final judgment be entered so that it could immediately appeal the non-infringement decision. Berkline requested that its invalidity and unenforceability counterclaims proceed to trial on the authority of Cardinal Chemical Co. v. Morton International, Inc., 508 U.S. 83, 113 S.Ct. 1967, 124 L.Ed.2d 1, 26 USPQ2d 1721 (1993). The court agreed with Berkline, stating "that further proceedings will be necessary on the issues of invalidity and inequitable conduct." After a bench trial, the court held that the patent was not invalid under 35 U.S.C. §§ 102 or 103 (1994), and that the claims in which the


location of the controls is not limited to the console (claims 1-8, 11, and 16-18) are not invalid under 35 U.S.C. § 112, ¶ 1 (1994). See Gentry II, 939 F.Supp. at 101-06, 41 USPQ2d at 1348-52. The court also held that Berkline had failed to prove that the patent was obtained by inequitable conduct and in so ruling noted that "[t]he evidence at trial was not even close." Id. at 101, 41 USPQ2d at 1347. The court denied Gentry's motion for the attorney fees it had incurred in overcoming Berkline's allegation of inequitable conduct. The court expressed "sympathy for Gentry, especially in view of Berkline's insistence on pressing the case after prevailing on the infringement issue," but nonetheless concluded that "these circumstances do not permit consideration of an award of fees."

Gentry appeals from the decision of non-infringement and the court's refusal to award attorney fees. Berkline cross-appeals from the decision that the claims are not invalid under §§ 103 or 112. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1) (1994).

DISCUSSION

A. INFRINGEMENT

Gentry argues that the district court erred in construing the claim terms "fixed" and "console" in granting summary judgment of non-infringement. Gentry asserts that the term "fixed" merely requires that the sofa section be rigidly secured to the adjoining recliners and that the term "console" refers to any sofa section that separates two recliners and can function as a tabletop. Accordingly, Gentry argues that on the undisputed facts it, not Berkline, is entitled to summary judgment on the issue of infringement. Berkline argues that summary judgment was properly granted because the term "fixed" requires that no part of the console be movable, while Berkline's sofa has a center seat back that can pivot. Berkline also argues that Gentry effectively defined a center seat with a retractable seat back as not a "console" when it distinguished the Brennan reference in the PTMS. On the basis of Berkline's second argument, we agree that it is entitled to judgment as a matter of law that it does not infringe the '244 patent.

We review a district court's grant of summary judgment de novo. See Conroy v. Reebok Int'l, Ltd., 14 F.3d 1570, 1575, 29 USPQ2d 1373, 1377 (Fed.Cir.1994). Summary judgment is appropriate when there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. See Fed.R.Civ.P. 56(c); Johnston v. IVAC Corp., 885 F.2d 1574, 1576-77, 12 USPQ2d 1382, 1383 (Fed.Cir. 1989). A determination of infringement requires a two-step analysis. "First, the claim must be properly construed to determine its scope and meaning. Second, the claim as properly construed must be compared to the accused device or process." Carroll Touch, Inc. v. Electro Mechanical Sys., Inc., 15 F.3d 1573, 1576, 27 USPQ2d 1836, 1839 (Fed.Cir. 1993).

Because there is no dispute concerning the structure of the accused device, our infringement analysis involves only claim construction, a question of law which we review de novo. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 979-81, 34 USPQ2d 1321, 1329-31 (Fed.Cir.1995) (in banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577, 38 USPQ2d 1461 (1996). The proper construction of claims is based upon the claim language, the written description portion of the specification, the prosecution history, and if necessary to aid the court's understanding of the patent, extrinsic evidence. See id. Our present analysis of infringement under the doctrine of equivalents involves prosecution history estoppel, also a question of law which we review de novo. See Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1579, 34 USPQ2d 1673, 1679 (Fed.Cir. 1995).

We agree with Gentry that the term "fixed" requires only that the console be rigidly secured to its two adjacent recliners. The term "fixed" and the explanatory clause "with the console and reclining seats together comprising a unitary structure" were added during prosecution to overcome a rejection based on a sectional sofa in which the seats were not rigidly attached. Thus, because the term "console" clearly refers to the complete section between the recliners, the term "fixed" merely requires that the console be rigidly attached to the recliners. Moreover, Berkline's interpretation of the term "fixed" unnecessarily excludes from the claim Sproule's preferred embodiment, in which the console can be opened by pivoting its lid. See Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583, 39 USPQ2d 1573, 1578 (Fed. Cir.1996) (noting that a claim interpretation that excludes the preferred embodiment "is rarely, if ever, correct"). Accordingly, as there is no dispute that Berkline's center seat and recliners form a unitary structure, we conclude that the "fixed" limitation is met by Berkline's sofas.


However, Berkline's sofas do not have a "console." The prosecution history indicates that the term "console" is not met by a sofa section having a seat back that folds down to serve as a table top, as in Brennan's seat or Berkline's sofas. As noted by the district court, Sproule's PTMS distinguished the Brennan reference in the following passage:*

Even if one were to apply the disclosure of reclining vehicle seats such as Brennan ... to furniture, one would not produce the pair of reclining seats joined by a center console as taught by [Applicant]. The tray units of Brennan ... while disposed between tandem reclining vehicle seats, are freestanding retractable structures that are not, per se, consoles nor do they join the pair of reclining seats as taught by Applicant. Rather Brennan shows a complete center seat with a tray unit in its back.

Gentry I, 30 USPQ2d at 1137 (emphasis added). This statement unambiguously indicates that the tray units in Brennan are not "consoles" as that term is used in the patent, regardless of the term's ordinary meaning or the way in which Gentry now urges us to interpret it. The relevant feature of Berkline's sofas, viz., a center seat back that may be folded down to provide a table top between the adjacent recliners, is indistinguishable from the comparable feature in Brennan, a fold-down tray table. In the PTMS, that feature was distinguished from the claimed "console." Thus, we conclude that Berkline's sofas do not contain the claimed "console." See Ekchian v. Home Depot, Inc., 104 F.3d 1299, 1304, 41 USPQ2d 1364, 1368 (Fed.Cir.1997) ("[S]ince, by distinguishing the claimed invention over the prior art, an applicant is indicating what the claims do not cover, he is by implication surrendering such protection."). The claims are therefore not literally infringed. Similarly, the argument advanced in the PTMS precludes recovery under the doctrine of equivalents because of prosecution history estoppel. Arguments made by an applicant in a PTMS can create an estoppel, and thus preclude a finding of infringement under the doctrine of equivalents. See id. at 1303-04, 41 USPQ2d at 1368 (Fed.Cir.1997) (regarding arguments made by an applicant in an Information Disclosure Statement). Accordingly, we affirm the judgment that Berkline does not infringe the patent.

B. INVALIDITY

In its cross-appeal, Berkline first argues that all of the claims of the patent are invalid under § 103 as having been obvious, based on the combination of U.S. Patent 4,668,009 ("Talley"), which discloses an armless recliner with a push-button control on its side, and an industry-standard sectional sofa ensemble developed by Kanowsky. Berkline asserts that "[a]nyone who set out to provide a side-by-side recliner configuration as in the `244 patent would recognize that all that was required was to replace the inside armless chair with an armless recliner." Berkline also argues that the district court clearly erred in finding that "the Talley recliner would be completely inappropriate for use in the sectional arrangement," Gentry II, 939 F.Supp. at 104, and that the invention enjoyed considerable commercial success. Gentry responds that the court properly relied on the testimony of Gentry's witnesses, including industrial sofa designer Billy Metts, while discounting Berkline's hindsight reconstruction of the invention. Based on this evidence, Gentry argues that the court did not err in finding that the combination of Talley and Kanowsky would not have rendered the invention obvious or that there existed a long-felt need for the invention, which became a commercial success.

We agree with Gentry that Berkline has not overcome the statutory presumption of validity, see 35 U.S.C. § 282 (1994), by proving facts that clearly and convincingly show that the claimed invention would have been obvious at the time the invention was made. On appeal from a bench trial, we review the legal conclusion of non-obviousness de novo, and the factual inquiries underlying that conclusion for clear error. See B.F. Goodrich Co. v. Aircraft Braking Sys. Corp., 72 F.3d 1577, 1582, 37 USPQ2d 1314, 1317-18 (Fed.Cir.1996).

Contrary to Berkline's argument, the mere possibility that the Talley and Kanowsky references could have been combined is insufficient to demonstrate that the claimed invention would have been obvious because, as noted above, the invention of the patent requires a "fixed console" between the recliners, which neither Talley nor Kanowsky provided. Moreover, even if the claimed invention did only involve the physical insertion of Talley's free-standing recliner into Kanowsky's sectional sofa, such simplicity alone is not determinative of obviousness. See In re Oetiker, 977 F.2d 1443, 1447, 24 USPQ2d 1443, 1446 (Fed.Cir.1992) ("Simplicity is not inimical to patentability."). In spite of the apparently facile combination, Metts testified: "[W]e had problems when we tried it ... because ours bumped against the side. It


[abutting the sofa units] would open it [the Talley recliner] prematurely." Later, he also admitted that he did not realize that this problem could have been solved by recessing the push-button slightly. Despite Berkline's protestations to the contrary, this "strong, credible testimony," Gentry II, 939 F.Supp. at 101, supports the finding that the Talley recliner was considered inappropriate for use in a sectional sofa by those skilled in the art. Accordingly, the court did not clearly err in finding that Talley would not have bridged the gap between Kanowsky and the claimed invention. Therefore, even leaving aside the district court's analyses of long felt need and commercial success, which can only further support nonobviousness, see Medtronic, Inc. v. Intermedics, Inc., 799 F.2d 734, 739 & n. 13, 230 USPQ 641, 643 & n. 13 (Fed.Cir.1986) (stating that "the absence of objective evidence [of long felt need and commercial success] is a neutral factor"), we conclude that Berkline has not proven that the invention would have been obvious at the time it was made.

Berkline also argues that claims 1-8, 11, and 16-18 are invalid because they are directed to sectional sofas in which the location of the recliner controls is not limited to the console. According to Berkline, because the patent only describes sofas having controls on the console and an object of the invention is to provide a sectional sofa "with a console ... that accommodates the controls for both the reclining seats," `244 patent, col. 1, ll. 35-37, the claimed sofas are not described within the meaning of § 112, ¶ 1. Berkline also relies on Sproule's testimony that "locating the controls on the console is definitely the way we solved it [the problem of building sectional sofa with parallel recliners] on the original group [of sofas]." Gentry responds that the disclosure represents only Sproule's preferred embodiment, in which the controls are on the console, and therefore supports claims directed to a sofa in which the controls may be located elsewhere. Gentry relies on Ethicon Endo-Surgery, Inc. v. United States Surgical Corp., 93 F.3d 1572, 1582 n. 7, 40 USPQ2d 1019, 1027 n. 7 (Fed.Cir.1996), and In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981), for the proposition that an applicant need not describe more than one embodiment of a broad claim to adequately support that claim.

We agree with Berkline that the patent's disclosure does not support claims in which the location of the recliner controls is other than on the console. Whether a specification complies with the written description requirement of § 112, ¶ 1, is a question of fact, which we review for clear error on appeal from a bench trial. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1116 (Fed.Cir.1991). To fulfill the written description requirement, the patent specification "must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed.Cir.1989). An applicant complies with the written description requirement "by describing the invention, with all its claimed limitations." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997).

It is a truism that a claim need not be limited to a preferred embodiment. However, in a given case, the scope of the right to exclude may be limited by a narrow disclosure. For example, as we have recently held, a disclosure of a television set with a keypad, connected to a central computer with a video disk player did not support claims directed to "an individual terminal containing a video disk player." See id. (stating that claims directed to a "distinct invention from that disclosed in the specification" do not satisfy the written description requirement); see also Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1405 (Fed.Cir.1997) (stating that the case law does "not compel the conclusion that a description of a species always constitutes a description of a genus of which it is a part").

In this case, the original disclosure clearly identifies the console as the only possible location for the controls. It provides for only the most minor variation in the location of the controls, noting that the control "may be mounted on top or side surfaces of the console rather than on the front wall ... without departing from this invention." `244 patent, col. 2, line 68 to col. 3, line 3. No similar variation beyond the console is even suggested. Additionally, the only discernible purpose for the console is to house the controls. As the disclosure states, identifying the only purpose relevant to the console, "[a]nother object of the present invention is to provide ... a console positioned between [the reclining seats] that accommodates the controls for both of the reclining seats." Id. at col. 1, ll. 33-37. Thus, locating the controls anywhere but on the console is outside the stated purpose of the invention. Moreover, consistent with this disclosure, Sproule's broadest original claim was directed to a sofa comprising, inter alia, "control means located upon the center console to enable each of the pair of reclining seats to move separately between the reclined and upright positions." Finally, although not dispositive, because one can add claims


to a pending application directed to adequately described subject matter, Sproule admitted at trial that he did not consider placing the controls outside the console until he became aware that some of Gentry's competitors were so locating the recliner controls. Accordingly, when viewed in its entirety, the disclosure is limited to sofas in which the recliner control is located on the console.

Gentry's reliance on Ethicon is misplaced. It is true, as Gentry observes, that we noted that "an applicant ... is generally allowed claims, when the art permits, which cover more than the specific embodiment shown." Ethicon, 93 F.3d at 1582 n. 7, 40 USPQ2d at 1027 n. 7 (quoting In re Vickers, 141 F.2d 522, 525, 61 USPQ2d 122, 125 (CCPA 1944)). However, we were also careful to point out in that opinion that the applicant "was free to draft claim[s] broadly (within the limits imposed by the prior art) to exclude the lockout's exact location as a limitation of the claimed invention" only because he "did not consider the precise location of the lockout to be an element of his invention." Id. Here, as indicated above, it is clear that Sproule considered the location of the recliner controls on the console to be an essential element of his invention. Accordingly, his original disclosure serves to limit the permissible breadth of his later-drafted claims.

Similarly, In re Rasmussen does not support Gentry's position. In that case, our predecessor court restated the uncontroversial proposition that "a claim may be broader than the specific embodiment disclosed in a specification." 650 F.2d at 1215, 211 USPQ at 326. However, the court also made clear that "[a]n applicant is entitled to claims as broad as the prior art and his disclosure will allow." Id. at 1214, 650 F.2d 1212, 211 USPQ at 326 (emphasis added). The claims at issue in Rasmussen, which were limited to the generic step of "adheringly applying" one layer to an adjacent layer, satisfied the written description requirement only because "one skilled in the art who read [the] specification would understand that it is unimportant how the layers are adhered, so long as they are adhered." Here, on the contrary, one skilled in the art would clearly understand that it was not only important, but essential to Sproule's invention, for the controls to be on the console.

In sum, the cases on which Gentry relies do not stand for the proposition that an applicant can broaden his claims to the extent that they are effectively bounded only by the prior art. Rather, they make clear that claims may be no broader than the supporting disclosure, and therefore that a narrow disclosure will limit claim breadth. Here, Sproule's disclosure unambiguously limited the location of the controls to the console. Accordingly, the district court clearly erred in finding that he was entitled to claims in which the recliner controls are not located on the console. We therefore reverse the judgment that claims 1-8, 11, and 16-18, were not shown to be invalid.

C. ATTORNEY FEES

Finally, Gentry argues that its success in overcoming Berkline's accusations of inequitable conduct entitles it to a partial award of attorney fees under 35 U.S.C. § 285 (1994) ("The court in exceptional cases may award reasonable attorney fees to the prevailing party."). Thus, Gentry asserts that the district court abused its discretion in refusing to consider an appropriate award of attorney fees. We do not agree.

The requirements for awarding attorney fees under section 285 are that "(1) the case must be exceptional, (2) the district court may exercise its discretion, (3) the fees must be reasonable, and (4) the fees may be awarded only to the prevailing party." Machinery Corp. of Am. v. Gullfiber AB, 774 F.2d 467, 470, 227 USPQ 368, 371 (Fed.Cir. 1985). Gentry's argument fails because it ignores the fourth criterion. Gentry is not "the prevailing party." When a plaintiff succeeds only in overcoming a defense raised to the claims it sought in bringing suit, the plaintiff is not "the prevailing party." Rather, to prevail within the meaning of section 285, Gentry must have achieved some of "the benefits ... sought in bringing suit," i.e., damages or an injunction. Hensley v. Eckerhart, 461 U.S. 424, 433 & n. 7, 103 S.Ct. 1933, 1939 & n. 7, 76 L.Ed.2d 40 (1983) ("[P]laintiffs may be considered `prevailing parties' for attorney's fees purposes if they succeed on any significant issue in litigation which achieves some of the benefit the parties sought in bringing suit."); see also Farrar v. Hobby, 506 U.S. 103, 111-12, 113 S.Ct. 566, 572-73, 121 L.Ed.2d 494 (1992) ("In short, a plaintiff `prevails' when actual relief on the merits of his claim materially alters the legal relationship between the parties by modifying the defendants' behavior in a way that directly benefits the plaintiff."); cf. Manildra Milling Corp. v. Ogilvie Mills, Inc., 76 F.3d 1178, 1183, 37 USPQ2d 1707, 1711 (Fed. Cir.1996) ("[A]s a matter of law, a party who has a competitor's patent declared invalid


meets the definition of `prevailing party.'"). Because Gentry was not "the prevailing party," we find no error in the district court's decision not to award attorney fees under section 285.

CONCLUSION

The district court's judgment holding that Berkline does not infringe the `244 patent, that the patent claims are not invalid under § 103 as obvious, and that Gentry is not entitled to attorney fees is affirmed. However, because the district court clearly erred in finding that the disclosure of the `244 patent describes a sectional sofa in which the location of the recliner controls is not limited to the console, we reverse the decision that

[134 F.3d 1481]

claims 1-8, 11, and 16-18 were not shown to be invalid under § 112, ¶ 1.

COSTS

No costs.

AFFIRMED-IN-PART and REVERSED-IN-PART.

FOOTNOTES

* Gentry asserts that Sproule distinguished the Brennan reference on several other grounds. Such an observation is not relevant to our analysis of the prosecution history, for even if Brennan was distinguished on multiple grounds, any of those grounds may indicate the proper construction of particular claim terms and provide independent bases for prosecution history estoppel.

f. Definite Claims

• case: Orthokinetics v. Safety Travel Chairs, Inc.

UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT

December 5, 1986 ORTHOKINETICS, INC., APPELLANT/CROSS-APPELLEE, v. SAFETY TRAVEL CHAIRS, INC., ENTRON, INC., WILLIAM J. PIVACEK, CLARK CHIPMAN, WILLIAM J. COLE, APPELLEES/CROSS-APPELLANTS

Appealed from: U.S. District Court for the Northern District of Ohio

Markey

Before MARKEY, Chief Judge, NEWMAN, Circuit Judge, and SWYGERT, Senior Circuit Judge.*fn*

MARKEY, Chief Judge

Appeal and cross-appeal from a judgment of the United States District Court for the Northern District of Ohio, Civil Action No. C81-130. In Appeal No. 85-2779, Orthokinetics, Inc. (Orthokinetics) appeals from orders: (1) granting a judgment notwithstanding the verdict (JNOV) holding that: (a) claims 5 and 6 of its U.S. Patent No. 3,815,586 ('586 patent) are invalid under 35 U.S.C. § 102(b) and § 103; (b) claims 1-5 of its U.S. Patent Re. 30,867 ('867 patent) are invalid under 35 U.S.C. § 103 and § 112; (c) the defendant officers of defendant corporations are not personally liable for patent infringement and the corporations

http://ne.findacase.com/research/wfrmDocViewer.aspx/xq/fac.19861205_0040079.cfc.htm/qx#D*fn2


are free from charges of willful infringement; and (2) conditionally granting a new trial. We reverse and remand with instructions to reinstate the jury verdicts.

In Appeal No. 85-2812, the defendants (collectively, Safety) appeal from the judgment entered on the verdict on patent infringement and misuse, and denial of a new trial on those issues. We affirm.

BACKGROUND

I. The Claimed Inventions

Orthokinetics manufactures products for invalids and handicapped individuals, including pediatric wheelchairs. It is the assignee of the '586 patent issued to Raymond A. Kazik (Kazik) on June 11, 1974, entitled "Orthopedic Chair With Scoliosis Pads" and of the '867 patent reissued to Edward J. Gaffney (Gaffney) on February 16, 1982, entitled "Travel Chair".

The '586 patent discloses a wheelchair for treating persons, especially children, afflicted with scoliosis or curvature of the spine. The orthopedic wheelchair has a head restraint and a pair of laterally and vertically adjustable scoliosis pads attached at opposite sides of the chair and so positioned as to provide therapeutic contact with opposite sides of a person seated in the chair. The relevant claims read:

1. In a chair having a seat, a back, and means for supporting the same, the improvement comprising a pair of scoliosis pads each adapted to bear against the sides of a human body, and means for mounting said pads adjacent to opposite side of said chair in such position as to provide therapeutic contact with opposite sides of a person seated in said chair for treatment of curvature of the spine.

2. The improvement defined in claim 1 wherein said mounting means for each pad is vertically adjustable to permit said pads to be positioned in a vertically staggered relationship to develop a therapeutic force couple across said person's trunk tending to straighten out said curvature of the spine.

5. The improvement of claim 2 in combination with a head restraint which coacts with the scoliosis pads to exert therapeutic pressure on the spine.

6. The improvement of claim 5 in which said head restraint comprises pads which embrace the head and means for adjustably positioning said pads with respect to said back.

On January 26, 1981, Orthokinetics sued, alleging infringement of claims 5 and 6 of the nine claims in the '586 patent. On December 31, 1977, it had disclaimed claims 1 through 4. Because claims 5 and 6 depend from claims 1 and 2, however, they contain all of the limitations of claims 1 and 2.

The '867 reissue patent discloses a collapsible pediatric wheelchair which facilitates the placing of wheelchair-bound persons, particularly children, in and out of an automobile. Orthokinetics asserted infringement of claims 1 through 5 by Safety. Claim 1 reads [underscoring indicates language added by reissue]:

1. In a wheel chair having a seat portion, a front leg portion, and a rear wheel assembly, the improvement wherein said front leg portion is so dimensioned as to be insertable through the space between the doorframe of an automobile and one of the seats thereof whereby said front leg is placed in support the seat portion from the automobile in the course of subsequent movement of the wheel chair into the automobile, and the retractor means for assisting the attendant in retracting said rear wheel assembly upwardly independently of any change in the position of the front leg portion with respect to the seat portion while the front leg portion is supported on the automobile and to a position which clears the space beneath the rear end of the chair and permits the chair seat portion and retracted rear wheel assembly to be swung over and set upon said automobile seat.

Claim 2 eliminates the language added by reissue in claim 1 and adds:


wherein said wheel chair has a chair frame including back portion extending upwardly from said seat portion and a front leg portion extending downwardly from said seat portion and wherein said rear wheel assembly includes a rear wheel frame that extends forwardly from said rear wheels and wherein said means for retracting said rear wheel assembly includes means pivotally connecting the front of said rear wheel frame to said chair frame, and a retractable strut connecting between said rear wheel assembly and said chair frame to support the wheel chair on the rear wheel assembly and to retract the rear wheel assembly upwardly under the chair seat portion by swinging said rear wheel frame upwardly.

Claim 3 limits the rear wheel frame of claim 2 to one which "comprises an upwardly arched undercarriage extending between said chair frame and rear wheels." Claim 4 limits the arch of the undercarriage of claim 3 to one which "substantially matches the angle between said seat portion and said front leg portion whereby said undercarriage swings into close proximity to said leg portion and seat portion when said rear wheel assembly is retracted." Claim 5 limits the chair frame of claim 3 to one which "comprises spaced support tubes, said upwardly arched undercarriage fitting between said tubes when the undercarriage is retracted." All five claims asserted are independent claims.

II. Procedural History

Orthokinetics introduced the Travel Chair to the market in November of 1973. In 1978, Safety Travel Chairs, Inc. (STC) began to sell similar chairs manufactured by Entron, Inc. (Entron). William J. Pivacek, Clark Chipman, and William J. Cole established STC and were the stockholders and officers of STC and Entron. When Orthokinetics sued STC, Entron, Pivacek, Chipman, and Cole, it alleged willful infringement of claims 5 and 6 of the '586 patent and various claims of its then U.S. Patent No. 3,891,229 ('229 patent). When the '229 patent reissued as the '867 patent on February 16, 1982, Orthokinetics amended its complaint to allege infringement of claims 1-5 of that patent, and demanded a jury trial. Safety answered that the patents were invalid and not infringed, and counterclaimed that Orthokinetics had misused its patents when it filed its complaint.

On the liability issues only, trial before a six-member jury was commenced on January 4, 1984, and continued until January 16. Unfortunately, the parties and the court did not decide, and apparently did not discuss, in a pretrial conference or otherwise before trial, just what the jury would be asked to do (e.g., return a general verdict, a general verdict accompanied by answers to interrogatories, or a series of special verdicts on individual issues).

At trial, the district court denied numerous motions for directed verdicts filed by the parties. Under Fed. R. Civ. P. 49 (the parties dispute whether under Rule 49(a) or (b)), the district court submitted to the jury a series of 54 jointly-prepared questions (samples of which are in the attached appendix). The questions recognized the appropriate burdens to be met by each of the parties as well as the corresponding standard of proof with respect to each issue. The jury returned its answers to the questions on anticipation, obviousness, infringement, willful infringement, misuse, and personal liability of the corporate officers. All were favorable to Orthokinetics.

Viewing the obvious/nonobvious conclusion as one that could be made only by the court, and therefore considering the jury's nonobvious verdict, after it was returned, to have been merely "advisory", the district court entered judgment on January 30, 1984 for Orthokinetics on the infringement and misuse issues only. On February 23, 1984, because it felt validity of the patents had not been decided, the district court denied Orthokinetics' motion for a temporary restraining order and preliminary injunction. On July 17, 1984, on becoming aware of this court's statement that "the obviousness/nonobviousness issue is a legal issue and may be submitted to the jury with proper instructions," Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 894-95, 221 U.S.P.Q. (BNA) 669, 674 (Fed. Cir.), cert. denied, 469 U.S. 857, 83 L. Ed. 2d 120, 105 S. Ct. 187 (1984), the district court entered judgment on the jury verdicts on patent validity and willful infringement.

Safety filed motions for JNOV on the issues of validity, infringement, and patent misuse, and in the alternative for a new trial.


III. Summary of the District Court's Opinion

On June 14, 1985, the district court filed a 69-page unpublished opinion, vacated its January 30 and July 17, 1984 judgments, and dismissed the complaint and counterclaim. It granted Safety's JNOV motion on validity, holding claims 5 and 6 of the '586 patent invalid because the claimed inventions were: (1) on sale or in public use, under § 102(b); and (2) described in a printed publication under § 102(b); and (3) obvious under § 103. The district court held claims 1-5 of the '867 patent invalid as: (1) indefinite under § 112; and (2) drawn to inventions that would have been obvious under § 103.

The district court denied and granted portions of Safety's motion for JNOV on infringement. In its denial, it held STC and Entron guilty of infringement. In its grant, it held that (1) Chipman, Cole, and Pivacek had not infringed either of the two patents and were not personally liable for their corporation's infringement; and (2) no defendant had committed acts of willful infringement.

The district court denied Safety's motion for JNOV on patent misuse.

The district court conditionally granted Safety a new trial if this court were to reverse the district court's entry of JNOV holding the patents invalid. See Fed. R. Civ. P. 50(c)(1), 59(a).

On August 9, 1985, the district court amended its opinion in response to a motion filed by Safety.

ISSUES

(1) Whether the district court erred in granting Safety's motion for JNOV on validity of the '586 and '867 patents.

(2) Whether the district court erred in denying Safety's motion for JNOV on infringement.

(3) Whether the district court erred in granting Safety's motion on personal liability of corporate officers.

(4) Whether the district court erred in granting Safety's motion for JNOV on willful infringement.

(5) Whether the district court erred in denying Safety's motion for JNOV on patent misuse.

(6) Whether the district court abused its discretion in conditionally granting Safety a new trial.

(1) Safety's Motion for JNOV on Validity

A. Introduction

This appeal presents an uncommon and somewhat incongruous situation. The district court entered JNOV on validity in favor of the party who had the burden at trial to prove facts by clear and convincing evidence that would require a conclusion of obviousness. 35 U.S.C. § 282; see, e.g., Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1550, 220 U.S.P.Q. (BNA) 193, 199-200 (Fed. Cir. 1983); Moore v. Shultz, 491 F.2d 294, 298-99, 180 U.S.P.Q. (BNA) 548, 551 (10th Cir.), cert. denied, 419 U.S. 930, 42 L. Ed. 2d 161, 95 S. Ct. 203, 183 U.S.P.Q. (BNA) 385 (1974). Under the law set by Congress, a jury or a court may reach a conclusion that a patent remains valid solely on the failure of the patent challenger's evidence to convincingly establish the contrary. A patent being presumed valid at birth, § 282, a patentee need submit no evidence in support of a conclusion of validity by a court or a jury. If the patent challenger introduces evidence that might lead to a conclusion of invalidity, a patentee would be well advised to introduce evidence sufficient to rebut that of the challenger. If the challenger's evidence be totally inadequate, a patentee's motion for judgment or directed judgment that the challenger's § 282 burden had not been carried would be appropriately granted before the patentee introduces any rebuttal evidence.


This appeal also illustrates the confusion created in the field of patent litigation by the unwillingness of patentees and alleged infringers to proceed under the rules applicable to all other types of litigation in which a statute or case law has assigned burdens of proof. Courts can hardly be criticized for confusing the burden assignment when counsel proceed as though the statute, § 282, did not exist.

As here, patentees have historically sought to "go first" with testimony on validity, on the empirically unproven premise that a favorable "first impression" of the merits of the invention will carry through to victory. Courts and alleged infringers have acquiesced in the practice. The resulting erroneous but clear impression that patentees bear a burden of "proving validity" has frequently resulted in cluttered records, irrelevant detours, undue burdens on the judicial process, and unnecessary work for the trial court.

Recognizing that trials conducted in accord with the statutorily assigned burdens would not result in assured victory or more victories for either side, courts should consider pretrial orders designed to facilitate such trials.

Similarly, courts should consider pretrial orders in jury trials that specify precisely what the jury will be asked to do after it has been given instructions prepared in light of the evidence and at the end of its deliberations: (1) return a general verdict ("we find for plaintiff/defendant"); (2) return a general verdict accompanied by answers to factual interrogatories prepared in light of the evidence; (3) return special verdicts on specific issues appearing in the evidence ("we find for plaintiff/defendant on the XXXXXXX issue"; or (4) merely "advise." Unfortunately, as counsel stated at oral argument, that was not done here.

B. Standard of Review

This court has recently reiterated the standard under Fed. R. Civ. P. 50(b) concerning a motion for JNOV in relation to an issue on which the movant did not have the burden of proof:

A trial judge presented with a motion for JNOV (1) must consider all the evidence in a light most favorable to the non-mover, (2) must not determine credibility of witnesses, and (3) must not substitute his or her choice for the jury's in finding facts, drawing inferences, or deciding between conflicting elements in the evidence. DMI, Inc. v. Deere & Co., 802 F.2d 421, 425, 231 U.S.P.Q. (BNA) 276, 278 2 (Fed. Cir. 1986); see Weinar v. Rollform Inc., 744 F.2d 797, 805, 223 U.S.P.Q. (BNA) 369, 373 (Fed. Cir. 1984), cert. denied, 470 U.S. 1084, 105 S. Ct. 1844, 85 L. Ed. 2d 143 (1985). If then the district court is "convinced upon the record before the jury that reasonable persons could not reach or could not have reached a verdict for the non-mover, it should grant the motion for directed verdict or for JNOV." Connell, 722 F.2d at 1546, 220 USPQ at 197; see Quaker City Gear Works, Inc. v. Skil Corp.,747 F.2d 1446, 1454-55, 223 U.S.P.Q. (BNA) 1161, 1166-67 (Fed. Cir. 1984), cert. denied, 471 U.S. 1136, 105 S. Ct. 2676, 86 L. Ed. 2d 694 (1985).

To convince this court that a trial judge erred in granting a motion for JNOV, an appellant need only show that there was substantial evidence to support the jury's findings and that those findings can support the jury's legal conclusion. Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 619, 225 U.S.P.Q. (BNA) 634, 636 (Fed. Cir.), cert. dismissed, 474 U.S. 976, 106 S. Ct. 340, 88 L. Ed. 2d 326 (1985); Railroad Dynamics, Inc. v. A. Stucki Co., 727 F.2d 1506, 1512, 220 U.S.P.Q. (BNA) 929, 936 (Fed. Cir.), cert. denied, 469 U.S. 871, 83 L. Ed. 2d 150, 105 S. Ct. 220, 224 U.S.P.Q. (BNA) 520 (1984). "'Substantial' evidence is such relevant evidence from the record taken as a whole as might be accepted by a reasonable mind as adequate to support the finding under review." Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 893, 221 U.S.P.Q. (BNA) 669, 673 (Fed. Cir.), cert. denied, 469 U.S. 857, 83 L. Ed. 2d 120, 105 S. Ct. 187 (1984).

Having carefully reviewed the record to determine whether there was such substantial evidence in support of each of the jury's critical findings, we are convinced that the district court inappropriately invaded the province of the jury, in derogation of Orthokinetics' rights as expressed in the Seventh Amendment to the Constitution.


C. The '586 patent (i) On Sale/Public Use, § 102(b)

The jury specifically found (question No. 31) that Safety failed to prove by clear and convincing evidence that the "subject matter" of claims 5 and 6 of the '586 patent was offered for sale or publicly used more than one year before its December 4, 1972 filing date. Because of that finding, the jury had no reason to, and did not answer the interrogatory on whether Orthokinetics had proved that what Safety alleged was a sale offer/public use was in fact done for an experimental purpose. The district court held that the jury's finding of no offer for sale or public use was "without basis in the record."

It was undisputed that Kazik and Gaffney took a prototype chair Kazik had built to several facilities including the Southern Colony Nursing Home in Wisconsin. On the basis of its view of Orthokinetics' answers to interrogatories and Kazik's trial testimony, the district court concluded that the chair taken to Southern Colony had all the elements of claims 5 and 6. The court stated that the "only testimony to the contrary, certain ambiguous remarks by Gaffney, contradict Orthokinetics' interrogatory answers." The court did not cite the record or otherwise identify the "remarks" referred to.

The district court then determined that the evidence "unmistakably reveals that the purpose of the trips to Southern Colony and other institutions was to commercialize the scoliosis pad chair," (though the jury made no finding on the purpose of the trips) and thus Orthokinetics was "not entitled to the 'experimental use' exception" (on which the jury also made no finding). Because there was insufficient evidence presented concerning the chairs brought to institutions other than Southern Colony, we mention those chairs no further.

The district court focused on evidence in support of Safety's contentions, rather than on evidence in support of the jury's findings. That approach constitutes reversible legal error, particularly where, as here, it involves a virtual disregard of substantial evidence on which the jury could reasonably have reached a contrary determination.

In referring to the evidence in support of the jury's verdict, the district court dismissed it as being "ambiguous". In that characterization, the district court lost sight of the rules, i.e., that resolution of ambiguities (assuming they existed) is a role assigned the jury, and inferences are to be drawn in favor of the nonmovant, Orthokinetics. Thus the court's dismissal of the evidence relied on by the jury as merely "ambiguous" was further legal error.

Orthokinetics points to substantial evidence showing that the Southern Colony chair lacked, among other things, a head restraint coacting with scoliosis pads with vertical adjustability, and that that chair's entire supporting structure and pad adjusting system was completely changed after the trip to Southern Colony. Alternatively, Orthokinetics challenges the district court's independent determination that it had not established that that chair was taken to Southern Colony for experimental purposes.

Focusing on its own evidence, Safety responds that "neither contention [of Orthokinetics] is supported by the evidence as a whole," thereby indicating a misunderstanding of our appellate role. If we were to determine what the "evidence as a whole" supports, there would be no need for trials or for Rule 50(b). Indeed, Safety's entire argument on appeal reflects its misunderstanding of the rules of Civil and Appellate Procedure governing a jury's role, a district court's role in reviewing motions for JNOV, and this court's role in reviewing that determination. Hence, acceptance of Safety's approach would not only violate established standards of review, but would render a jury impotent.

Safety concedes that the parties submitted evidence on both sides of each issue. Safety then attacks Orthokinetics' evidence, which is not at issue. As above indicated, Safety bore the burden under 35 U.S.C. § 282, and the jury had the right to reject its evidence as insufficient to carry that burden. Under those circumstances, this court may determine only whether the evidence the jury could have believed in making its critical findings was substantial. Because a jury must by definition be permitted to accept some probative evidence and reject other probative evidence, we may not decide whether we would as jurors have found Orthokinetics' evidence, in Safety's words, "believable in light of the evidence as a whole." This is not a case in which there was no evidence in support of a jury's finding, or one in which the only


evidence relating to a finding was contrary to that finding. See Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1550, 220 U.S.P.Q. (BNA) 193, 200 (Fed. Cir. 1983) ("the jury finding that there was 'no prior art' could not possibly stand in the face of the numerous clearly relevant prior art patents in the trial record").

As too often occurs, the parties here have difficulty restricting themselves to the language of the claims. In distinguishing the Southern Colony chair, for example, Orthokinetics cites a structural feature, "shown" in the patent and a feature that was later modified; yet those features are not found as limitations in the claims.

There is, however, substantial evidence that the Southern Colony chair did not have the claimed elements "a head restraint which coacts with the scoliosis pads" or a "head restraint which comprises pads which embrace the head." It is clear that the jury could have so concluded on the evidence presented to it. Gaffney testified as to that difference, and the exhibits showing the Southern Colony chair fully support that testimony. Moreover, Kazik did not testify, and Orthokinetics' interrogatory answers did not state, that that chair had a head restraint coacting with the pads. Whether there may or may not have been evidence that might have supported a contrary conclusion is simply irrelevant. Because there was substantial evidence supporting it, the jury's determination that there was no offer for sale or public use of the claimed invention should not have been disturbed. The judgment NOV on the on sale or in public use bar must be vacated and judgment must be entered on the jury's verdict.

Because there was substantial evidence on which a reasonable jury could have found that Safety failed to prove an offer for sale or public use of the claimed invention, we need not discuss the district court's independent determination that Orthokinetics had not established an experimental purpose in the trip to Southern Colony. In light of the instructions given the jury, moreover, it must be concluded that any consideration it gave the question of experimental purpose was resolved by the jury in Orthokinetics' favor. Nonetheless, for the benefit of the parties, we note that Orthokinetics did come forward with evidence of an experimental purpose sufficient to have convinced the jury that even the possibility of a public use bar had been "negated". TP Laboratories, Inc. v. Professional Positioners, Inc., 724 F.2d 965, 971, 220 U.S.P.Q. (BNA) 577, 582 (Fed. Cir.), cert. denied, 469 U.S. 826, 83 L. Ed. 2d 51, 105 S. Ct. 108, 224 U.S.P.Q. (BNA) 616 (1984); see also In re Smith, 714 F.2d 1127, 218 U.S.P.Q. (BNA) 976 (Fed. Cir. 1983).

Gaffney testified at trial that the purpose of the trip to Southern Colony was to "test [the chair] with some handicapped children to see if it was ready" and "to see if the chair was ready to be commercialized and if it would do the job we wanted it to do." The jury had the right to construe that testimony as establishing that Orthokinetics was still in an experimental phase when the visit was made to Southern Colony. Whether Kazik's statement that the trip was to see "the scope of the market" might support a contrary conclusion is of no moment in the course of considering a motion for JNOV. The district court's characterization of Kazik's and Gaffney's testimony as "undisputed" is but an indication that the jury was entitled to resolve a conflict, if any existed, between them, and that any inferences to be drawn from that testimony must be drawn adversely to Safety.

(ii) Printed Publication

The jury found (question No. 26) that Safety failed to prove that the chair claimed in the '586 patent was present in its entirety in Kamenetz, The Wheelchair Book: Mobility for the Disabled (1969) (The Wheelchair Book). The district court held that The Wheelchair Book "clearly discloses" all five elements of claims 5 and 6 of the '586 patent.

Orthokinetics' witnesses testified that the structure disclosed in The Wheelchair Book does not include "a head restraint which coacts with the scoliosis pads to exert therapeutic pressure on the spine," as set forth in the claims, particularly because the "head rest" in The Wheelchair Book is only a head rest and not a "head restraint" at all. A reasonable jury could clearly have found from that testimony that The Wheelchair Book does not anticipate the claimed inventions because it discloses no "head restraint" and certainly no "head restraint which coacts with the scoliosis pads to exert therapeutic pressure on the spine."


The district court correctly determined that The Wheelchair Book shows "headrests, headcushions, headwings and special head supports (including slings, caps, and collars)." That the reference shows those items, however, is simply no basis for finding anticipation. The claims require "head restraints" that are not shown by the reference. The district court was in no position to conclude that headwings embrace the head like a head restraint. Orthokinetics' expert, Professor Cherry, testified that headwings normally "support" the head, but do not "restrain" it. Because anticipation requires the disclosure in a prior art reference of each and every element as set forth in the claim, Kalman v. Kimberly-Clark Corp., 713 F.2d 760, 771, 218 U.S.P.Q. (BNA) 781, 789 (Fed. Cir. 1983), cert. denied, 465 U.S. 1026, 79 L. Ed. 2d 687, 104 S. Ct. 1284, 224 U.S.P.Q. (BNA) 520 (1984), The Wheelchair Book cannot anticipate the claimed inventions set forth in claims 5 and 6. See RCA Corp. v. Applied Digital Data Systems, Inc., 730 F.2d 1440, 221 U.S.P.Q. (BNA) 385 (Fed. Cir.), cert. dismissed, 468 U.S. 1228, 105 S. Ct. 32, 82 L. Ed. 2d 923 (1984).

There being substantial evidence capable of supporting the jury's finding of no anticipation, and thus a failure of Safety to prove anticipation, the granting of Safety's motion for JNOV on anticipation by The Wheelchair Book must be reversed.

(iii) Obviousness

The jury concluded (question Nos. 27-29) that Safety had failed to prove by clear and convincing evidence that the inventions set forth in claims 5 and 6 would have been obvious to persons of ordinary skill in any of a number of arts, including a person "with mechanical skills who has the knowledge of the needs of handicapped children." The district court said that "the jury's answers to [those questions] were without foundation in the evidence."

Again the district court focused on evidence in support of Safety's burden. Noting that Orthokinetics' disclaimer of claims 1-4 was in light of U.S. Patent No. 3,640,571, to Michael Keropian (Keropian), that Keropian disclosed all the elements recited in claims 1-4, and finding that The Wheelchair Book, H. Willard & C. Spackman, Occupational Therapy (4th ed. 1971), and U.S. Patent No. 3,269,768 to John C. Kinney (Kinney) disclose "head restraints", the district court concluded that it would have been obvious to add the "headrests to the Keropian scoliosis system, or to add the Keropian vertically adjustable torso system to the Kinney head rest and chair mechanism." With those references, the court concluded, "a person of ordinary skill in the art . . . would easily have been able to produce the structure defined by the ['586] patent."

Acceptance of the district court's foregoing analysis would make the conduct of the jury trial a pointless exercise. In accord with its instructions, the jury necessarily concluded that the combining of individual items picked from the references as later done by the district court, would not have produced the claimed inventions or would not have been obvious when the invention was made. No basis or reason exists in the record for the district court to have substituted its contrary conclusion. The jury heard the testimony of Safety's own witness, Professor Cherry, who testified on the improvements contributed in the '586 patent. Those improvements did not consist of a mere combining of a "head rest" with Kinney's scoliosis system; they contributed a coaction between the pads and a head restraint to provide therapeutic pressure at three points. Moreover, that the claims do not contain the phrase "three-point positioning" is not material, the coaction between the pads being effective to produce that result. See In re Antonie, 559 F.2d 618, 619, 195 U.S.P.Q. (BNA) 6, 8 (CCPA 1978) (claims need not recite inherent advantages relied on for patentability).

Moreover, the district court's analysis employed an inappropriate "would have been able to produce" test. The statute, § 103, requires much more, i.e., that it would have been obvious to produce the claimed invention at the time it was made without the benefit of hindsight.

The jury also found (question Nos. 34-37) that Orthokinetics had proved by a preponderance of the evidence that certain objective indicia support the validity of the '586 patent, i.e., unsuccessful attempts by others, long felt need, and commercial success. Though the district court viewed those jury findings as


"without factual foundation," the record reflects substantial evidence on which a reasonable jury could have made each of those findings.

Because the district court erred in setting aside the jury's verdict that the inventions set forth in claims 5 and 6 would not have been obvious, the grant of Safety's motion for JNOV on the validity of the '586 patent must be reversed.

D. The '867 Patent

(i) Indefiniteness

The jury found (question No. 51) that Safety failed to prove by clear and convincing evidence that the '867 patent was invalid because of claim language that does not particularly point out and distinctly claim the invention. 35 U.S.C. § 112, 2d P. The district court determined otherwise and granted Safety's motion for JNOV.

Claim 1, from which the rest of the claims depend, contains the limitation: "wherein said front leg portion is so dimensioned as to be insertable through the space between the doorframe of an automobile and one of the seats thereof."

Nothing the testimony of Orthokinetics' expert, Mr. Hobbs, who said the dimensions of the front legs depend upon the automobile the chair is designed to suit, the district court stated:

In response to this testimony, which clearly and convincingly establishes that claim 1 of the ['867] patent does not describe the invention in "full, clear, concise and exact terms," Orthokinetics points only to the conclusory statements of Hobbs, Gaffney and expert witness William McCoy, Jr., that the patent is, in fact definite. These conclusory statements are not an adequate basis for the jury to reject Safety's defense. The undisputed, specific testimony of Gaffney and Hobbs demonstrates that an individual desiring to build a noninfringing travel chair cannot tell whether that chair violates the ['867] patent until he constructs a model and tests the model on vehicles ranging from a Honda Civic to a Lincoln Continential to a Checker cab. Without those cars, "so dimensioned" is without meaning.

The foregoing statement employs two measures impermissible in law: (1) it requires that claim 1 "describe" the invention, which is the role of the disclosure portion of the specification, not the role of the claims; and (2) it applied the "full, clear, concise, and exact" requirement of the first paragraph of § 112 to the claim, when that paragraph applies only to the disclosure portion of the specification, not to the claims. Standard Oil Co. v. American Cyanamid Co., 774 F.2d 448, 453, 227 USPQ (BNA) 293, 297 (Fed. Cir. 1985). The district court spoke, inappropriately, of indefiniteness of the "patent," and did not review the claim for indefiniteness under the second paragraph of § 112.

A decision on whether a claim is invalid under § 112, 2d P, requires a determination of whether those skilled in the art would understand what is claimed when the claim is read in light of the specification. Seattle Box Co. v. Industrial Crating & Packing Inc., 731 F.2d 818, 826, 221 U.S.P.Q. (BNA) 568, 574 (Fed. Cir. 1984); In re Marosi,710 F.2d 799, 803, 218 U.S.P.Q. (BNA) 289, 292 (Fed. Cir. 1983).

It is undisputed that the claims require that one desiring to build and use a travel chair must measure the space between the selected automobile's doorframe and its seat and then dimension the front legs of the travel chair so they will fit in that particular space in that particular automobile. Orthokinetics' witnesses, who were skilled in the art, testified that such a task is evident from the specification and that one of ordinary skill in the art would easily have been able to determine the appropriate dimensions. The jury had the right to credit that testimony and no reason exists for the district court to have simply discounted that testimony as "conclusory".

The claims were intended to cover the use of the invention with various types of automobiles. That a particular chair on which the claims read may fit within some automobiles and not others is of no moment.


The phrase "so dimensioned" is as accurate as the subject matter permits, automobiles being of various sizes. See Rosemount, Inc. v. Beckman Instruments, Inc., 727 F.2d 1540, 1547, 221 U.S.P.Q. (BNA) 1, 7 (Fed. Cir. 1984). As long as those of ordinary skill in the art realized that the dimensions could be easily obtained, § 112, 2d P requires nothing more. The patent law does not require that all possible lengths corresponding to the spaces in hundreds of different automobiles be listed in the patent, let alone that they be listed in the claims.

Compliance with the second paragraph of § 112 is generally a question of law. Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 619, 225 U.S.P.Q. (BNA) 634, 636 (Fed. Cir.), cert. dismissed, 474 U.S. 976, 106 S. Ct. 340, 88 L. Ed. 2d 326 (1985). On the record before us, we observe no failure of compliance with the statute, and thus no basis on § 112 grounds for disturbing the jury's verdict. The district court's grant of Safety's motion for JNOV for claim indefiniteness was in error and must be reversed.

(ii) Obviousness

The jury made numerous findings (question Nos. 39-48) all in support of its conclusion that Safety failed to prove by clear and convincing evidence that the inventions set forth in claims 1-5 of the '867 patent would have been obvious when they were made in view of the prior art to one of ordinary skill in the art.

Having outlined the prosecution history of the '867 reissue patent, the district court stated:

Analysis begins with Gaffney's concession to the [U.S. Patent and Trademark Office] that [U.S. Patent No. 1,693,633 issued to Sarah Allen (Allen)] fully anticipated the original Gaffney patent, rendering that patent void under § 102. Therefore, the only novel aspects of the reissue patent [i.e. the '867 patent] claims are those portions of such claims which differ from the language of the original patent. Claim 1 added to the original Claim 1 a "retractor means for assisting the attendant in retracting said rear wheel assembly . . . while the front leg is supported on the automobile. . . ."

The district court quoted the language added by reissue in claims 2-5, supra, and focused on the differences between the reissued '867 claims and those of the original '229 patent. Claims 3-5 were also characterized as adding "minor details."

It is not altogether clear from the passage quoted above whether the district court was comparing the claims of the '867 patent with Allen or with the original patent. A careful reading of the district court's opinion, and its amendments, however, makes clear that the claims of the original patent were applied as prior art against the '867 patent. That was legal error for the reasons discussed in Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1137, 227 U.S.P.Q. (BNA) 543, 546-47 (Fed. Cir. 1985), and Safety's attempt to distinguish that case is unpersuasive.

If the district court compared the '867 claims with the Allen patent, that comparison was based on an erroneous presumption, i.e., that Gaffney made a "concession" that Allen anticipated the claims of the original patent. Gaffney's reissue oath stated only that he believed "the original patent to be wholly or partly inoperative or invalid because claims 1 and 11 are unpatentable over [Allen]." 35 U.S.C. § 251; see 37 C.F.R. § 1.175(1) (1985); Manual of Patent Examining Procedure 1414 (5th ed. 1983). That is not, as Safety calls it, a "binding admission" of anticipation. In fact, even a cursory review of the Allen patent shows on its face that the jury could readily have found that it does not disclose each element of Gaffney's original patent.

The district court stated (underscoring indicates amendments adding to the court's original opinion; brackets indicate amendments deleting from the court's original opinion):

Given the jury's findings with respect to the level of ordinary skill in the art, the proper scope and content of the prior art and its details as summarized above, and assuming that the jury's general verdict constitutes a sufficient finding concerning the differences between the prior art and the Gaffney reissue


patent claims, the question for this Court is whether any reasonable basis existed for [finding those differences] their finding. On consideration, it is eminently clear that no such basis exists -- that is, that all the differences between claims 1 through 5 of the Gaffney reissue patent [are] and the prior art are such that the claimed invention as a whole would have been obvious in light of the prior art to one of ordinary skill in the art at the time of the Gaffney invention. [Footnotes omitted.]

The district court's amendment changing "the differences are obvious" to "the claimed invention as a whole would have been obvious to one of ordinary skill at the time of the invention" substituted the correct statutory criteria, § 103, for the unauthorized "differences are obvious" standard. Despite that change, however, it is clear from the entire record and from a study of the amended opinion in its entirety, that the court substituted its view for that of the jury on the basis of its belief that the presence of individual elements in separate prior patents required a conclusion of obviousness.

The court concluded that (emphasis added):

clear and convincing evidence demonstrates that in 1972 the holder of a college degree in engineering with experience in the wheel chair fields, presented with the Allen patents and the other patents described above, would doubtless have been able to produce the structure defined in claims 1 through 5 of the Gaffney reissue patent; no probative evidence to the contrary was presented to the jury. The prior art suggests the combination both expressly and by implication, and no original new patent's result is achieved which is not suggested by the combinations. Applying the Railroad Dynamics test, this Court concludes that the jury's implied conclusion that there were differences between the prior art and the claims in issue is unsupported by substantial evidence.

As it did in respect of the '586 patent, the court applied its " able to produce" standard in place of the statutory "obvious" standard of § 103. There was probative evidence in support of the jury's conclusion (testimony of Hobbs, Gaffney, Kazik, Inouye, Pivacek). Neither the court nor any witness identified what in the references suggested their combination or what in the references would produce the results of the claimed inventions.

It is unclear whether the district court believed there were no differences between the claimed inventions of the '867 patent and the prior art. Though the court listed no differences, it is undisputed that there are at least these differences: the combination of legs as lever for loading the chair into an automobile and the retraction of the rear wheels by the attendant while the patient remains in the chair. The sole question, therefore, is whether that difference, which we must presume was found by the jury, constituted substantial evidence in support of its nonobvious conclusion.

A review of each of the five prior art references establishes unequivocally that there was substantial evidence in support of the jury's implied findings of those differences. That evidence plus the objective evidence of nonobviousness (commercial success, failure of others, long felt need) supply a fully adequate basis on which a reasonable juror could have concluded that the subject matter as a whole of the inventions claimed in the '867 patent would not have been obvious to one of ordinary skill in the art. Neither the record nor the district court's opinion provides a basis for the substitution of a conclusion to the contrary. Therefore, the district court's setting aside of the jury's verdict upholding claims 1-5 of the '867 patent must be reversed.

(2) Infringement

The jury found (question Nos. 1-4) that Orthokinetics had met its burden of proving by a preponderance of the evidence that the accused chairs constituted infringement of claims 5 and 6 of the '586 patent. The testimony of Gaffney and Inouye, which supports that finding, faced no cross-examination and went unrebutted by Safety. The district court correctly denied Safety's motion for JNOV on infringement of the '586 patent.


Safety's sole argument on appeal is directed to matter extraneous to claims 5 and 6 of the '586 patent and is clearly without merit.

The jury found (question No. 15) that Orthokinetics had proved by a preponderance of the evidence that the accused chairs constituted infringement of claims 1-5 of the '867 patent. Safety sought JNOV on this issue, arguing that the claims must be limited to a rigid front leg portion extending to the floor, or to a front leg portion having a caster and a caster board fixedly mounted thereon, the leg portion being no wider than 9 1/2 inches at the caster board.

Because Orthokinetics' completely contrary testimonial evidence was fully adequate to support the jury's findings, the district court correctly denied Safety's motion for JNOV on infringement of the '867 patent. For the same reason, Safety's motion for new trial on infringement was properly denied.

(3) Personal Liability for Infringement

The jury found (question Nos. 5-10, 18-23) that Chipman, Cole and Pivacek were personally liable for acts of direct infringement and for inducing infringement of both patents.

The district court held as a matter of law that, because the jury could not have reasonably found the corporate officers liable for willful infringement, it could not find them personally liable for any infringing acts of the corporations. In attempting to support that holding, Safety argues that good faith belief in invalidity, based solely on a dealer's report that a district court had held the original of the '867 patent invalid, precludes a finding of any personal liability. Because neither proposition has any basis in law, we must reverse the district court's grant of Safety's motion for JNOV on the corporate officers' personal liability.

The jury found the corporate officers liable for direct infringement, 35 U.S.C. § 271(a), as well as for inducing infringement, § 271(b). The district court's opinion did not treat the finding on inducement, but dealt only with general principles involved in imposition of personal liability for acts of a corporation. However, it is well settled that corporate officers who actively aid and abet their corporation's infringement may be personally liable for inducing infringement under § 271(b) regardless of whether the corporation is the alter ego of the corporate officer. Power Lift, Inc. v. Lang Tools, Inc., 774 F.2d 478, 481, 227 U.S.P.Q. (BNA) 435, 437 (Fed. Cir. 1985).

Corporate officers are presumably aware of what they are doing, and in that sense they can be said to have acted "willfully." However, that does not mean that their acts must rise to the level recognized by the law as constituting willful infringement before they can be liable for infringement by their corporation. Hence the district court erred in positing willful infringement as a prerequisite for the imposition of personal liability for the corporation's direct infringement.

To determine whether corporate officers are personally liable for the direct infringement of the corporation under § 271(a) requires invocation of those general principles relating to piercing the corporate veil.

Infringement is a tort, Carbice Corp. v. American Patents Development Corp., 283 U.S. 27, 33, 8 U.S.P.Q. (BNA) 211, 213, 75 L. Ed. 819, 51 S. Ct. 334 (1931), and officers of a corporation are personally liable for tortious conduct of the corporation if they personally took part in the commission of the tort or specifically directed other officers, agents, or employees of the corporation to commit the tortious act. See generally 3A W. Fletcher, Cyclopedia of the Law of Private Corporations § 1135 (rev. perm. ed. 1975). The cases are legion in which courts have recognized and imposed personal liability on corporate officers for participating in, inducing, and approving acts of patent infringement. See, e.g., White v. Mar-Bel, Inc., 509 F.2d 287, 185 U.S.P.Q. (BNA) 129 (5th Cir. 1975); Rex Chainbelt, Inc. v. General Kinematics Corp., 363 F.2d 336, 150 U.S.P.Q. (BNA) 319 (7th Cir. 1966); see generally D. Chisum, Patents, § 16.06, at 16-76 to 16-85 (1986).


The evidence established the makeup and control of STC and Entron. Pivacek testified that he was at all material times the President and sole stockholder of Entron and that he elected its Board of Directors. He also testified that he is the President of STC and that he, Cole, and Chipman held all of STC's directorships and owned all of the stock in STC. The evidence firmly establishes that Pivacek, Cole and Chipman were directly responsible for the design and production of the infringing chairs and that they were the only ones who stood to benefit from sales of those chairs. That evidence was fully sufficient to support the jury's imposition of personal liability on Pivacek, Cole, and Chipman for the direct infringement of STC and Entron and for STC's contributory infringement. The district court's setting aside of the jury's findings on personal liability must therefore be reversed.

(4) Willful Infringement of the '867 Patent

Fed. R. Civ. P. 50(a) states that a "motion for a directed verdict shall state the specific grounds therefor." Rule 50(b) states that "a party who has moved for a directed verdict may move to have the verdict and any judgment entered thereon set aside and to have judgment entered in accordance with his motion for a directed verdict." A specific reference to an issue in a motion for JNOV cannot preserve that issue for appeal where that issue was not specifically included in a motion for directed verdict made before the jury retired to consider its verdict. See, e.g., Kinzenbaw v. Deere & Co., 741 F.2d 383, 387, 222 U.S.P.Q. (BNA) 929, 931 (Fed. Cir. 1984), cert. denied, 470 U.S. 1004, 84 L. Ed. 2d 379, 105 S. Ct. 1357 (1985).

Faced with its failure to have moved for directed verdict on willful infringement, Safety argues that its motion for directed verdict on infringement encompasses willfulness. That argument is without merit. Infringement and willful infringement are not the same thing, and Rules 50(a) and 50(b) mandate specificity.

Alternatively, however, Safety says Orthokinetics cannot raise on appeal Safety's failure to include willfulness in its motion for directed verdict because Orthokinetics never objected to its inclusion in Safety's motion for JNOV before the district court.

Orthokinetics' reliance here on a page in its brief on the motion is insufficient because that page is not of record before us. Moreover, Orthokinetics' oral statements to the district court indicate that it never intended to contest the inclusion of the issue of willfulness in Safety's JNOV motion. Though the district court might well have refused consideration of willfulness on the motion for JNOV in light of Rule 50(b), it did not. In view of Orthokinetics' failure to raise an objection before the district court, we will consider the issue. Cox v. City of Freeman, Missouri, 321 F.2d 887, 891 (8th Cir. 1963).

The district court determined that, because Safety was told by a dealer of a district court's ruling in another case that the original '229 patent was invalid, (Palmer v. Orthokinetics, Inc., 197 U.S.P.Q. (BNA) 207 (C.D. Cal. 1977), rev'd, 611 F.2d 316, 204 U.S.P.Q. (BNA) 893 (9th Cir. 1980)), no reasonable and fair minded juror could have found willful infringement, and set aside the jury's findings that STC, Entron, Cole, and Chipman willfully infringed the '867 patent.

A finding of willful infringement is based on a totality of the circumstances. See, e.g., Kloster Speedsteel AB v. Crucible Inc., 793 F.2d 1565, 1579-80, 230 U.S.P.Q. (BNA) 81, 90-91 (Fed. Cir. 1986) and cases cited therein. It is not necessary to determine which combination of facts, among those established by substantial evidence at trial and recognized by this court as capable of contributing to a willfulness finding, were relied upon by the jury. This court, and the district court on the motion for JNOV, must uphold the jury determination of willfulness if there is any set of facts supported by substantial evidence and capable of supporting that jury determination. See, e.g., Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 619, 225 U.S.P.Q. (BNA) 634, 636 (Fed. Cir.), cert. dismissed, 474 U.S. 976, 106 S. Ct. 340, 88 L. Ed. 2d 326 (1985); Railroad Dynamics, Inc. v. A. Stucki Co., 727 F.2d 1506, 1512, 220 U.S.P.Q. (BNA) 929, 936 (Fed. Cir.), cert. denied, 469 U.S. 871, 83 L. Ed. 2d 150, 105 S. Ct. 220, 224 U.S.P.Q. (BNA) 520 (1984).

In this case, substantial evidence supports the jury's finding (question No. 24) of willful infringement. The evidence shows that Safety did not consult an attorney until after Orthokinetics initiated this action. The


district court's view that Safety could have relied on a dealer's report of a district court ruling in the Palmer case that the original '229 patent was invalid and thus need not have consulted an attorney is insufficient in this case to set aside the jury's finding of willful infringement. Had Safety relied on that prior district court ruling, one might expect that it would have sought counsel when Orthokinetics informed Safety that that ruling had been reversed on appeal. See Palmer v. Orthokinetics, Inc., 611 F.2d 316, 204 U.S.P.Q. (BNA) 893 (9th Cir. 1980), rev'g, 197 U.S.P.Q. (BNA) 207 (C.D. Cal. 1977). Instead, Safety merely continued to infringe. Moreover, Safety never replied to any of the letters sent by Orthokinetics and declined Orthokinetics' invitation to participate as a protestor in the reissue proceedings.

The jury could properly have viewed the aforementioned evidence as sufficient to establish Safety's complete disregard of Orthokinetics' patent rights. Therefore, the district court's grant of JNOV on willfulness must be reversed.

The corporate officers being personally liable for the acts of the corporations, and the corporations being liable for willful infringement, the jury's finding that Cole and Chipman are willful infringers must be upheld.

(5) Patent Misuse

Because no prior art anticipated the claims of the '586 patent, Safety's assertion that Orthokinetics is guilty of patent misuse for asserting a patent, the '586 patent, that it knew was invalid under § 102(b), is without merit.

With respect to the '867 patent, the district court deemed Safety's confused series of assertions, involving the settlement agreement in the Palmer case and Palmer's customer, unworthy of analysis and insufficient to overcome the jury's finding (question no. 52) which the district court found to have been supported by substantial evidence. We agree.

The district court correctly denied Safety's motion for JNOV on patent misuse and Safety's motion for a new trial on that issue.

(6) Conditional Grant of a New Trial

This court must review a denial or grant of a motion for a new trial under an abuse of discretion standard. Medtronic, Inc. v. Intermedics, Inc., 799 F.2d 734, 740-41, 230 U.S.P.Q. (BNA) 641, 645 (Fed. Cir. 1986); Railroad Dynamics Inc., 727 F.2d at 1512, 220 USPQ at 935. "That question turns on whether an error occurred in the conduct of the trial that was so grievous as to have rendered the trial unfair." DMI, Inc. v. Deere & Co., 802 F.2d 421, 427, 231 U.S.P.Q. (BNA) 276, 280 (Fed. Cir. 1986); see Witco Chemical Corp. v. Peachtree Doors, Inc., 787 F.2d 1545, 1548, 229 U.S.P.Q. (BNA) 188, 190 (Fed. Cir.), cert. dismissed, 479 U.S. 877, 107 S. Ct. 258, 93 L. Ed. 2d 241 (1986).

The district court stated that "a new trial is compelled solely by the standards set forth in the Federal Circuit's post-trial Structural Rubber Products [Co. v. Park Rubber Co., 749 F.2d 707, 223 U.S.P.Q. (BNA) 1264 (Fed. Cir. 1984)] case, when read in conjunction with applicable Sixth Circuit law on Fed. R. Civ. P.49(a)." The district court derived that "Sixth Circuit law" exclusively from "reading liberally," as it said, Sakamoto v. N.A.B. Trucking Co., 717 F.2d 1000, 1006 (6th Cir. 1983).

More specifically, the district court concluded that a new trial would be in order because: (1) the parties "were prejudiced by delivering closing arguments without the benefit of a final -- or even a substantially completed -- version of the special verdict," citing Sakamoto; (2) the jury instructions and special verdicts failed to set forth what specific facts had to be found to support a general verdict on validity or infringement, citing Sakamoto and Structural Rubber; and (3) "substantial injustice ensued from [the court's] efforts to determine the appropriate role of judge and jury at the same time that the Federal Circuit was generating a series of decisions examining the same topic." With respect to reason (3), the district court determined:


Had counsel been aware that factual issues on validity were being submitted to the jury for binding verdicts, they might well have made different submissions, proposals and objections with respect to both the jury instructions and the special verdict. And had this Court been aware that the validity verdict would be binding, it certainly would have taken a different approach to the validity instructions and verdict.

The district court's reasons for a new trial are based on a speculative and overly expansive view of the case law. Moreover, it does not point to any specific flaws in the instructions as given, or what different proposals, objections, and approach would have been taken or justified.

Regarding reason (1), the Sakamoto court held that "the disclosure prior to final argument of at least the substance of the Rule 49(a) special verdict interrogatories and supplemental instructions is mandatory." 717 F.2d at 1006 (emphasis added). That court noted "that it may be an abuse of discretion to fail to show the Rule 49(a) interrogatories to counsel in advance of argument where, because of exceptional circumstances, such as the complexity of the case, unfairness would otherwise result." However, the Sakamoto court determined that the appellant had shown no prejudice from the district court's failure to disclose the additional interrogatory before the summation. Noting that counsel's failure to object or request further argument, and everyone's awareness of the issue represented by the additional interrogatory, established an absence of prejudice, the Sixth Circuit affirmed the district court's denial of a new trial.

Whether the present case may be categorized as falling within Rule 49(a) or Rule 49(b), Sakamoto makes clear that Safety must show actual prejudice, which it failed to do. Safety knew what the issues were from the filing of the pretrial briefs onward and certainly when it assisted with the jointly-prepared jury instructions before closing argument. Moreover, like the appellant in Sakamoto, Safety made no objection and no request for further argument.

Regarding reason (2), the district court determined that Sakamoto "indicates that a general verdict included together with special verdict questions is impermissible, or at best null." For the reasons set forth above, we do not read Sakamoto for that proposition.

The district court said Structural Rubber mandates "that a general verdict is valid only if it is the product of instructions which clearly lay out alternative mandatory general verdicts when specific facts are found." In this case, however, there was no objection to the instructions as failing to lay out alternative verdicts based on the evidence adduced.

In Structural Rubber, this court remanded for a partial new trial because instructions were given on issues on which no evidence was presented. The alternative mandatory verdict instructions discussed in Structural Rubber are desirable and facilitate both jury deliberations and appellate review. This court did not hold in that case that every general verdict is invalid if that particular type instruction was not given. Nor did it hold that a new trial is compelled in such instances when the parties have agreed to the instructions given.

Moreover, in the present case, the jury did not return a general verdict ("we find for the plaintiff"). It returned a series of hybrid special verdicts on each issue with answers to questions on what had and had not been proven.

In all events, non-objecting parties should not be forced to retry the case merely because the instructions and the form of verdict obtained from the jury did not match those involved in any earlier and different case, particularly where the party who failed to convince the jury has shown no prejudice emanating from the instructions given. See Bio-Rad Laboratories, Inc. v. Nicolet Instrument Corp., 739 F.2d 604, 615, 222 U.S.P.Q. (BNA) 654, 662 (Fed. Cir. 1984), cert. denied, 469 U.S. 1038, 83 L. Ed. 2d 405, 105 S. Ct. 516 (1984).

Under Fed. R. Civ. P. 51, the failure of Safety to proffer timely, specific objections to the instructions precludes our consideration of any such objection on appeal absent great injustice. Roberts v. City of


Troy, 773 F.2d 720, 723 (6th Cir. 1985); Structural Rubber, 749 F.2d at 714 & n.3, 223 USPQ at 1269 & n.3. Safety's sole timely objection may have been (assuming it was brought to the court's attention before the jury retired, see Transcontinental Leasing, Inc. v. Michigan National Bank of Detroit, 738 F.2d 163, 167 (6th Cir. 1984)) to the instruction stating the irrelevancy of the doctrine of prosecution history estoppel when the jury finds literal infringement. The district court correctly determined that instruction to have been proper. See, e.g., Fromson v. Advance Offset Plate, Inc., 720 F.2d 1565, 1571, 219 U.S.P.Q. (BNA) 1137, 1141 (Fed. Cir. 1983). There is no merit in Safety's present contention that that instruction misled the jury into not construing the claims in light of the prosecution history, particularly when other instructions told the jury to do precisely that. Instructions must be read in their entirety. See, e.g., Batesole v. Stratford, 505 F.2d 804, 809 (6th Cir. 1974); Gradsky v. Sperry Rand Corp., 489 F.2d 502, 503-04 (6th Cir. 1973).

Regarding reason (3), neither Safety nor the district court has indicated how or why the jury might have made different findings or reached different conclusions if Safety or the court had known the jury's verdicts on obviousness would be binding. Nothing of record indicates that either party or the court expected that any jury verdict would be merely "advisory".*fn1 This court had made clear, before this trial, that jury verdicts in patent cases are binding. See White v. Jeffrey Mining Machinery Co., 723 F.2d 1553, 1558, 220 U.S.P.Q. (BNA) 703, 705 (Fed. Cir. 1983), cert. denied, 469 U.S. 825, 83 L. Ed. 2d 49, 105 S. Ct. 104 (1984); Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1547, 220 U.S.P.Q. (BNA) 193, 197-98 (Fed. Cir. 1983). Having failed to carry its burden before one jury, Safety has shown no such actual prejudice as would warrant a second chance before a second jury and the consequent doubling of the burden on Orthokinetics and the district court.

The case was fully and fairly litigated, the instructions and interrogatories (to which Safety did not object) were jointly prepared and fully adequate to guide the jury in its consideration of the evidence presented. There exists no newly-discovered material evidence. A new trial would therefore be unwarranted. The district court's conditional grant of a new trial was an abuse of discretion and must be vacated.

Conclusion

The judgment entered in response to those of Safety's motions for JNOV that were granted is reversed. The judgment entered on the jury verdict in light of the denial of Safety's other motions for JNOV is affirmed. The district court's denial of Safety's motion for a new trial on infringement and misuse is affirmed. The district court's conditional grant of a new trial on validity is vacated.

The case is remanded for entry of judgment on the jury's verdicts, for issuance of an appropriate permanent injunction against infringement by Safety, for an accounting, and for such further proceedings not inconsistent with this opinion as the district court may deem necessary.

AFFIRMED IN PART, VACATED IN PART, REVERSED IN PART, AND REMANDED

APPENDIX

Question 2

Do you find that Orthokinetics has proved by a preponderance of the evidence that defendant, Safety Travel Chairs, Inc., has directly infringed the following claims of the ['586] patent by sale of Safety TranSporter Chair Models with adjustable scoliosis pads?

Please answer: "proved" or "not proved" as to each claim:

Claim 5 "Proved"

Claim 6 "Proved"

http://ne.findacase.com/research/wfrmDocViewer.aspx/xq/fac.19861205_0040079.cfc.htm/qx#D*fn1


Question 5

Do you find that Orthokinetics has proved by a preponderance of the evidence that the defendant, Clarke Chipman, is personally liable for direct infringement of the ['586] patent?

Please answer: "Proved" or "not proved":

"Proved"

Question 24

Do you find that Orthokinetics has proved by a preponderance of the evidence that the infringement of the ['867] patent by any of the following defendants was willful?

Please answer: "proved" or "not proved":

Safety "Proved"

Entron "Proved"

William Cole "Proved"

Clark Chipman "Proved"

Question 31

Have Safety et al. proved by clear and convincing evidence that the ['586] patent is invalid because the subject matter of claims 5 and 6 was publicly used or offered for sale more than one year before the December 4, 1972 filing of the ['586] patent application?

Please answer: "proved" or "not proved":

"Not proved"

Question 40

Do you find that Safety et al. have proved by clear and convincing evidence that the ['867] patent is invalid because the differences, if any, between the prior art and the claimed subject matter, taken as a whole, would not have been obvious to one of ordinary skill in the art at the time the claimed invention was made?

Please answer: "proved" or "not proved" as to each claim of the ['867] patent:

Claim 1 "Not proved"






6. OWNERSHIP OF PATENT AND TRANSFER OF RIGHTS SECS. 28-30, IP CODE SEC. 28. Right to a Patent. – The right to a patent belongs to the inventor, his heirs, or assigns. When two (2) or more persons have jointly made an invention, the right to a patent shall belong to them jointly. (Sec. 10, R.A. No. 165a) SEC. 29. First to File Rule. – If two (2) or more persons have made the invention separately and independently of each other, the right to the patent shall belong to the person who filed an application for such invention, or where two (2) or more applications are filed for the same invention, to the applicant who has the earliest filing date or, the earliest priority date. (3rd sentence, Sec. 10, R.A. No. 165a) SEC. 30. Inventions Created Pursuant to a Commission. – 30.1. The person who commissions the work shall own the patent, unless otherwise provided in the contract. 30.2. In case the employee made the invention in the course of his employment contract, the patent shall belong to:

a. The employee, if the inventive activity is not a part of his regular duties even if the employee uses the time, facilities and materials of the employer; and

b. The employer, if the invention is the result of the performance of his regularly-assigned duties, unless there is an agreement, express or implied, to the contrary. (n)

SECS. 67-70, IP CODE

CHAPTER VII REMEDIES OF A PERSON WITH

A RIGHT TO A PATENT SEC. 67. Patent Application by Persons Not Having the Right to a Patent. – 67.1. If a person referred to in Section 29 other than the applicant is declared by final court order or decision as having the right to the patent, such person may, within three (3) months after the decision has become final:

a. Prosecute the application as his own application in place of the applicant; b. File a new patent application in respect of the same invention; c. Request that the application be refused; or


d. Seek cancellation of the patent, if one has already been issued.

67.2. The provisions of Subsection 38.2 shall apply mutatis mutandis to a new application filed under Subsection 67.1(b). (n) SEC. 68. Remedies of the True and Actual Inventor. – If a person, who was deprived of the patent without his consent or through fraud is declared by final court order or decision to be the true and actual inventor, the court shall order for his substitution as patentee, or at the option of the true inventor, cancel the patent, and award actual and other damages in his favor if warranted by the circumstances. (Sec. 33, R.A. No. 165a) SEC. 69. Publication of the Court Order. – The court shall furnish the Office a copy of the order or decision referred to in Sections 67 and 68, which shall be published in the IPO Gazette within three (3) months from the date such order or decision became final and executory, and shall be recorded in the register of the Office. (n) SEC. 70. Time to File Action in Court. – The actions indicated in Sections 67 and 68 shall be filed within one (1) year from the date of publication made in accordance with Sections 44 and 51, respectively. (n)

SEC. 236, IP CODE SEC. 236. Preservation of Existing Rights. –Nothing herein shall adversely affect the rights on the enforcement of rights in patents, utility models, industrial designs, marks and works, acquired in good faith prior to the effective date of this Act. (n)

• case: Albana v. Director of Patents – see attachment

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