Upload
others
View
1
Download
0
Embed Size (px)
Citation preview
[email protected] Paper No. 8 571-272-7822 Entered: September 8, 2016
UNITED STATES PATENT AND TRADEMARK OFFICE ____________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________
COOK MEDICAL LLC, Petitioner,
v.
STONE BASKET INNOVATIONS LLC, Patent Owner. ____________
Case IPR2016-00713 Patent 6,551,327 B1
____________
Before PHILLIP J. KAUFFMAN, BARRY L. GROSSMAN, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. PAULRAJ, Administrative Patent Judge.
DECISION Institution of Inter Partes Review
37 C.F.R. § 42.108
IPR2016-00713 Patent 6,551,327 B1
2
I. INTRODUCTION
Cook Medical LLC (“Petitioner”) filed a Petition (Paper 2, “Pet.”),
requesting institution of an inter partes review of claims 1–8 of
U.S. Patent No. 6,551,327 B1 (Ex. 1001, “the ’327 patent”). Stone Basket
Innovations LLC (“Patent Owner”) timely filed a Preliminary Response
(Paper 7, “Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 314,
which provides that an inter partes review may not be instituted “unless . . .
there is a reasonable likelihood that the petitioner would prevail with respect
to at least 1 of the claims challenged in the petition.”
Upon consideration of the Petition and the Preliminary Response, and
for the reasons explained below, we determine that Petitioner has shown that
there is a reasonable likelihood that it would prevail with respect to at least 1
of the challenged claims of the ’327 patent. We thus institute an inter partes
review.
A. Related Proceedings As a related proceeding, the parties indicate that the ’327 patent is
currently at issue in Stone Basket Innovations LLC v. Cook Medical LLC,
Case No. 2:15-cv-00464, pending in the United States District Court for the
Eastern District of Texas. Pet. 1–2; Paper 5, 2.
B. The ’327 Patent (Ex. 1001) The ’327 patent issued on April 22, 2003, from an application filed on
January 17, 2001, and names Avtar S. Dhindsa as its sole inventor. Ex.
1001, Title Page. The ’327 patent relates generally to an endoscopic stone
extraction device including a handle that supports a movable sheath, a
IPR2016-00713 Patent 6,551,327 B1
3
filament such as a wire slidably disposed in the sheath, and a stone
extraction basket attached to one end of the filament. Id., Abstract; Fig. 1.
An embodiment of the endoscopic stone extraction device is shown in
Figure 1 of the ’327 patent, reproduced below:
As depicted above, Figure 1 shows a perspective view of endoscopic stone
extraction device 10 that includes handle 12 that in turn includes grip 14 and
slide 16, which is mounted to slide longitudinally along the length of the
grip. Ex. 1001, 1:63–65, 2:19–24. Tubular sheath 18, which defines lumen
19, is secured to slide 16. Id. at 2:25–26. The device also includes filament
22 having first end 24 (not shown) that is rotatably secured to grip 14, and
second end 26 that supports stone extraction basket 28. Id. at 2:31–34.
Figure 10 of the ’327 patent, reproduced below, shows an
embodiment of the stone extraction basket for use with the device:
IPR2016-00713 Patent 6,551,327 B1
4
As depicted above, Figure 10 shows an enlarged perspective view of stone
extraction basket 28' with stone entrance region 100' positioned adjacent to
second end 26 of filament 22, and stone retention region 102' positioned
opposite second end 26. Id. at 2:13–15, 5:1–5.
The ’327 patent teaches that “[t]he stone extraction devices described
[therein] can be used with the widest variety of endoscopes, including
uretoscopes, nephroscopes and other endoscopic devices.” Id. at 5:51–54.
The ’327 patent further teaches that “[a]s used herein, the term ‘stone’ is
intended to broadly encompass a wide variety of biological stones, calculus
and the like, including fragments” thereof. Id. at 5:55–59.
C. Illustrative Claims
Petitioner challenges claims 1–8 of the ’327 patent. Independent
claim 1 is illustrative of the claimed subject matter, and is reproduced below:
IPR2016-00713 Patent 6,551,327 B1
5
1. An endoscopic stone-extraction device comprising: a support filament comprising a first end portion and a second
end portion; a sheath comprising a lumen, the support filament disposed in
the lumen such that the sheath is slideable with respect to the support filament;
a collapsible stone-extraction basket carried by the first end portion of the support filament and receivable within the lumen of the sheath;
a handle comprising a sheath movement element, wherein movement of the sheath movement element in a first direction advances the sheath and causes the basket to at least partially collapse inside the lumen of the sheath, and wherein movement of the sheath movement element in a second direction retracts the sheath and causes the basket to expand to an operational shape outside the lumen of the sheath;
the basket, when expanded to the operation shape outside the lumen of the sheath, comprising a stone-entrance region and a stone-retention region, the stone-entrance region comprising a first opening sized to admit a stone into the basket, the stone-retention region comprising a plurality of second openings, all of the second openings being smaller than the first opening;
the first opening facing the first end portion of the support filament, the stone-retention region positioned on a side of the basket opposite the first end portion of the support filament;
wherein the basket comprises a set of longitudinal basket filaments radiating from the first end portion of the support filament and a set of lateral basket filaments extending between the longitudinal basket filaments, the lateral basket filaments positioned substantially entirely in the stone-retention region of the basket.
D. The Asserted Grounds of Unpatentability Petitioner challenges the patentability of the claims of the ’327 patent
on the following grounds:
IPR2016-00713 Patent 6,551,327 B1
6
References Basis Claim(s) challenged
Tsugita1 and any of the Sheath Movement Element (SME) Prior Art2
§ 103 1–8
Leslie and any of Tsugita, Bates II, or Bates IV
§ 103 1–8
Bates I and either Tsugita or Bates IV3
§ 103 1–8
Petitioner relies upon the Declaration of Robert H. Wagoner, Ph.D.
(Ex. 1028) in support of its patentability challenges.
II. ANALYSIS
A. Claim Construction
We interpret claims using the “broadest reasonable construction in
light of the specification of the patent in which [they] appear[].” 37 C.F.R.
§ 42.100(b); see also Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131,
2142 (2016) (affirming applicability of broadest reasonable construction
standard to inter partes review proceedings). Under the broadest reasonable
construction standard, claim terms are generally given their ordinary and
customary meaning, as would be understood by one of ordinary skill in the
1 Tsugita et al., U.S. Patent 6,165,200, issued Dec. 26, 2000 (Ex. 1003, “Tsugita”). 2 Petitioner identifies the following references collectively as “SME Prior Art”: a) Leslie et al., U.S. Patent 6,168,603 B1, issued Jan. 2, 2001 (Ex. 1004, “Leslie”); b) Bates et al., U.S. Patent 5,496,330, issued Mar. 5, 1996 (Ex. 1005, “Bates I”); c) Bates et al., U.S. Patent 6,099,534, issued Aug. 8, 2000 (Ex. 1006, “Bates II”); d) Boston Scientific Microvasive Publication (Ex. 1008); e) Cook Atlas Extractor Publication (Ex. 1009); and f) Cook Market Information Bulletin (Ex. 1010). 3 Bates et al., U.S. Patent 6,179,859 B1, issued Jan. 30, 2001 (Ex. 1013, “Bates IV”).
IPR2016-00713 Patent 6,551,327 B1
7
art at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249,
1257 (Fed. Cir. 2007). “Absent claim language carrying a narrow meaning,
the PTO should only limit the claim based on the specification . . . when [it]
expressly disclaim[s] the broader definition.” In re Bigio, 381 F.3d 1320,
1325 (Fed Cir. 2004). “Although an inventor is indeed free to define the
specific terms used to describe his or her invention, this must be done with
reasonable clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d
1475, 1480 (Fed. Cir. 1994).
1. “Endoscopic” (Preamble)
Patent Owner asserts that the term “endoscopic,” as used in the
preamble’s recitation of “an endoscopic stone-extraction device,” is a
limitation of claim 1. Prelim. Resp. 8–10. Patent Owner asserts that “[t]he
Federal Circuit has repeatedly held that a preamble term is a limitation when
the intrinsic evidence emphasizes the importance of the term” and “[t]he
Federal Circuit has also found a preamble term to be a limitation when the
importance of the term is underscored in the patent by, for example, use of
the term in the title, abstract, summary or the specification.” Id.
We are not persuaded, based on the present record, that the term
“endoscopic” recited in the preamble is a limitation. Generally, the Federal
Circuit has held that the preamble limits a claim only if it recites essential
structure or is otherwise “necessary to give life, meaning, and vitality” to the
claim, and that the preamble is not limiting when the claim body defines a
structurally complete invention and the preamble states only a purpose or
intended use. See Pitney Bowes, Inc. v. Hewlett–Packard Co., 182 F.3d
1298, 1305 (Fed.Cir.1999) (citing Kropa v. Robie, 38 CCPA 858, 187 F.2d
150, 152 (1951)), Rowe v. Dror, 112 F.3d 473, 478 (Fed.Cir.1997).
IPR2016-00713 Patent 6,551,327 B1
8
Here, the body of claim 1 recites a structurally complete invention,
and the term “endoscopic” appears to be merely an intended use recitation
that does not add any further structural requirements to the claimed device.
Indeed, while arguing that the term should be treated as a limitation, Patent
Owner itself indicates that it “does not believe ‘endoscopic’ requires
construction, but to the extent the Board believes the term requires
construction, it should be construed to mean, ‘configured for use with an
endoscope.’” Prelim. Resp. 10. Patent Owner, however, does not explain
what type of structure is required by a device that is “configured for use with
an endoscope.” Nor has Patent Owner explained how the term “endoscopic”
gives life, meaning, and vitality to the claim. Accordingly, we do not
consider the term to be a limitation in our preliminary analysis for purposes
of institution.
2. “Sheath Movement Element”
Claim 1 of the ’327 Patent states that “movement of the sheath
movement element in a first direction advances the sheath and causes the
basket to at least partially collapse inside the lumen of the sheath” and that
“movement of the sheath movement element in a second direction retracts
the sheath and causes the basket to expand to an operational shape outside of
the lumen of the sheath.” Ex. 1001, 6:19–27.
Petitioner argues that, under its broadest reasonable construction, the
term “sheath movement element” means “any part of the device that can be
used to move the sheath to open and close the basket.” Pet. 10 (Citing Ex.
1028, ¶¶ 77–78). Patent Owner contends that the term “sheath movement
element” does not require construction, but to the extent the Board construes
the term, it should mean “an element on the handle for sliding the sheath
IPR2016-00713 Patent 6,551,327 B1
9
relative to the support filament.” Prelim. Resp. 11. Patent Owner asserts
that this construction appropriately reflects the express claim language that
“the sheath is slideable with respect to the support filament” and the “handle
compris[es] a sheath movement element.” Id.
On this record, we adopt Petitioner’s proposed construction of “sheath
movement element” in our preliminary analysis for purposes of institution.
However, we do not perceive any meaningful dispute over the construction
of this term. For example, Patent Owner has not argued that any of the prior
art does not teach or suggest a “sheath movement element” under its
proposed construction. Nonetheless, we agree with Patent Owner that the
claims require that the “the sheath is slideable with respect to the support
filament” and the “handle compris[es] a sheath movement element,” and
have taken those express claim recitations into account as part of our
analysis of Petitioner’s patentability challenges.
3. Other Claim Terms
We determine that no other claim term requires express construction
for purposes of deciding whether to institute a review in this case. See, e.g.,
Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011)
(“[C]laim terms need only be construed ‘to the extent necessary to resolve
the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
F.3d 795, 803 (Fed. Cir. 1999))).
The claim constructions in this Decision are preliminary
determinations. They do not preclude the parties from asserting their
proposed constructions of the claims during trial. Indeed, the claim
construction issues discussed in the Petition, Preliminary Response, and this
IPR2016-00713 Patent 6,551,327 B1
10
Decision put the parties on notice that claim construction, in general, is an
issue to be addressed at trial.
B. Prior Art Relied Upon
Petitioner relies upon the following prior art references in its
patentability challenges. In addition to these references, Petitioner also
describes several other prior art references as background information
1. Tsugita (Ex. 1003)
Tsugita is directed to percutaneous catheter and guidewire having
filter and medical device deployment capabilities. Ex. 1003, Title. The
device taught by Tsugita is used for treating plaque depositions and
occlusions within major blood vessels. Id. at 1:15–23 (Field of the
Invention).
Tsugita’s catheter includes filter device 30 that generally comprises
introducer sheath 32, guidewire 40, and expandable filter assembly 50. Id.
at 7:52–55. “The sheath 32 has a proximal end 34 and a distal end 36,” and
“[t]he guidewire 40, typically a flexible, substantially resilient wire, having a
distal end 42 and a proximal end 44, is inserted into the proximal end 34 of
the sheath 32 through a lumen.” Id. at 7:58–63. Additionally, expandable
filter assembly 50 is attached on or near distal end 42 of guidewire 40. Id. at
7:66–67.
Figure 8A of Tsugita, reproduced below, shows an embodiment of the
filter assembly used for the catheter:
IPR2016-00713 Patent 6,551,327 B1
11
As depicted in longitudinal view above, filter assembly 50 comprises a
plurality of struts 54 having filter mesh 60 attached thereon, wherein “the
struts 54 are shown having a radiused shape bias to expand radially when the
filter assembly 50 is first introduced into the blood vessel.” Id. at 6:41–43,
12:48–56. Tsugita teaches that an exemplary embodiment of the mesh has a
“pore size” of 60–100 µm. Id. at 9:5–8. The “[f]ilter mesh is attached
typically between the intermediate region and the distal ends of the struts,
thereby defining a substantially hemispherical or conical shaped filter
assembly.” Id. at 3:61–64.
2. Leslie (Ex. 1004)
Leslie teaches a “surgical extractor for removing objects from a body
including, for example, calculi, such as kidney stones and gall stones.” Ex.
1004, Abstract. The surgical extractor “includes a retrieval basket with
distal and proximal ends and a retractable sheath,” wherein “[t]he retractable
sheath in a first position retains the retrieval basket in a compact condition
and in a second position frees the retrieval basket for expansion to form an
enlarged basket that comprises a plurality of wires extending between the
distal and proximal ends of the basket.” Id. at 4:36–44. Leslie further
IPR2016-00713 Patent 6,551,327 B1
12
teaches that the sheath connects to a slider for axial displacement. Id. at
4:59–63, 5:7–13.
Figures 1 and 4 of Leslie are reproduced below:
Figure 1 shows a plan view of a surgical extractor with a handle at the
proximal end and an expanded retrieval basket at the distal end. Id. at 5:23–
25. Figure 4 shows an enlarged view of the distal end of the extractor with
the retrieval basket in a compact form inside the sheath. Id. at 5:32–34.
During operation,
a physician will introduce the extractor 10 with its distal end 16 in the form shown in FIG. 4 so the sheath 17 retains the retrieval basket 15 in its compact form. When the distal end 16 is positioned proximate at calculi or any other object to be retrieved, the physician moves the slider 14 from position 14B to the position 14 in FIG. 1. This retracts the sheath 17 and exposes the second and third sections 20 and 21 of the basket assembly 18. The wires return to their original shape as shown in FIG. 2 thereby to dilate surrounding tissue and to provide a structure that can be manipulated to capture calculi within the confines of the retrieval basket 15.
IPR2016-00713 Patent 6,551,327 B1
13
Id. at 6:52–63.
3. Bates I (Ex. 1005)
Bates I teaches a surgical extractor with a similar structure and
manner of operation to the device disclosed in Leslie, as discussed above.
See Ex. 1005, Abstract; Fig. 1; 3:36–50, 4:22–38.
4. Bates II (Ex. 1006)
Bates II teaches a medical retrieval device that includes a basket used
to retrieve material (e.g., a urinary stone) from a body. Ex. 1006, Abstract.
The retrieval device “includes basket 10, a catheter or sheath 18 for
introduction of the basket 10 into a tract, and at least one cable 20 extending
and moveable within the sheath 18.” Id. at 5:12–15. Bates II further teaches
that
the device also includes a proximal handle 9 at the proximal end of the sheath 18, and this handle typically includes one or more actuating mechanisms (e.g., a slide, a knob, a dial, etc.) coupled to the sheath 18 and/or the cable 20 for causing the sheath 18 and the basket 10, under operator control, to move relative to each other to move the basket from a collapsed position within the sheath to an extended position outside of the sheath.
Id. at 5:16–24.
5. Boston Scientific Microvasive Publication (Ex. 1008)
Ex. 1008 appears to be a marketing publication describing Boston
Scientific’s Microvasive line of stone extractors. It includes the following
figure:
IPR2016-00713 Patent 6,551,327 B1
14
Ex. 1008, 5–9. The figure above depicts a “French Segura BasketsTM”
device, and the corresponding description notes that “2.4 French sheath
advances easily through flexible ureteroscope working channels and
maximizes irrigation capability.” Id.
6. Cook Publications (Exs. 1009, 1010)
The Cook Publications describe a stone extractor with a “Unidex”
handle that “facilitates easy one-handed operation.” Ex. 1009, 2; Ex. 1010,
2–3. The Cook Stone Extractor Publication notes that “[t]he basket itself
remains immobile. It is the sheath that is pulled back to reveal the basket.
This enhances placement and decreases the likelihood that the stone will
become dislodged while closing the basket.” Ex. 1010, 2.
7. Bates IV (Ex. 1013)
Bates IV teaches an emboli filtration apparatus having a filter
element, as shown in Figure 2A, reproduced below:
IPR2016-00713 Patent 6,551,327 B1
15
As depicted above,
filter element 30 comprises funnel-shaped filter sac 31 coupled to a plurality of self-expanding struts 32 at proximal end 33 and soft elastomer cone 34 at distal end 35. Struts 32 are affixed to capture ring 36, and self-expand from a contracted state, when filter element is disposed in lumen 24 of catheter 21, and a deployed state, when filter element is ejected from delivery sheath 20. In the deployed state, struts 32 extend outward to urge the perimeter of sac 31 into engagement with the walls of a vessel.
Ex. 1013, 4:10–19.
C. Patentability Challenges
1. Obviousness Based on Tsugita in View of Sheath Movement Element (SME) Prior Art
Petitioner asserts that claims 1–8 are obvious over Tsugita in view of
any one of the “SME Prior Art” references (i.e., Leslie, Bates I, Bates II, the
Boston Scientific Microvasive Publication, or the Cook Publications). Pet.
19–20; 24–26. Specifically, Petitioner asserts that Tsugita teaches all the
requirements of claim 1, with the exception of a “sheath movement
element.” Id. at 24. Petitioner asserts that “a handle comprising a sheath
IPR2016-00713 Patent 6,551,327 B1
16
movement element was well-established in the prior art,” and that “each of
the stone extraction devices in the SME Prior Art . . . disclosed a ‘handle
comprising a sheath movement element’ that caused the basket to open and
close by moving the sheath backward or forward.” Id. at 25. Petitioner
further asserts that, “in the related district court litigation, the named
inventor admitted at his deposition that the addition of a handle comprising a
sheath movement element did not confer any novelty on the claimed
invention.” Id. (citing Ex. 1011, 142). Petitioner contends that the skilled
artisan would have been motivated to combine Tsugita’s disclosures “(which
focused on capturing emboli within blood vessels) with any one of the stone
extraction devices disclosed in the SME Prior Art Patents” a) because the
references address the “common problem of capturing and removing objects
from body passageways,” and b) in order “to address the problem of
captured stones becoming dislodged when the physician moved the basket in
an effort to close it.” Id. at 28–29. Petitioner cites to the Wagoner
Declaration (Ex. 1028) as support for these motivations. Id.
With respect to dependent claim 2, Petitioner asserts that Tsugita
discloses a concave surface meeting the claim’s requirements, as shown in
Figure 8A. Id. at 29–30. With respect to the size requirements of dependent
claims 3, 4, and 6, Petitioner asserts that “Tsugita discloses the use of mesh
with holes (second openings) at 0.06–0.10 mm in dimension, which is
smaller than 2 mm (Claim 3) and 5 mm (Claim 6).” Id. at 30 (citing Ex.
1003, 9:5–8). Additionally, Petitioner asserts that the skilled artisan would
have found it obvious to design a basket with holes within the claimed
ranges because “[i]t was well known in 2001 that the diameter of fragmented
kidney stones ranged from 2–10 mm.” Id. at 30–31 (citing Ex. 1007, 8:59–
IPR2016-00713 Patent 6,551,327 B1
17
60; Ex. 1028, ¶¶ 134–137). Petitioner also asserts that Tsugita or any one of
the SME Prior Art references discloses the requirement in dependent claim 5
that the support filament and basket are free of attachment to the sheath,
such that the entire basket is movable into the lumen of the sheath. Id. at 31.
Finally, Petitioner asserts that the SME Prior Art references teach the
requirement in dependent claim 7 that movement of the sheath movement
element in the first direction causes the basket to completely collapse inside
the lumen of the sheath, as well as the requirement in dependent claim 8 that
“the sheath movement element comprises a slide, wherein the handle
comprises a grip, and wherein the slide is mounted for translation relative to
the grip.” Id. at 32.
Based on the current record, including the arguments and claim charts
presented with the Petition, we preliminarily agree with Petitioner’s
contention that claims 1–8 would have been obvious over Tsugita in view of
any one of the SME Prior Art references. The only argument with respect to
this challenge presented in Patent Owner’s Preliminary Response is that the
Petition fails to show that the combination of Tsugita and the SME Prior Art
references discloses “an endoscopic stone-extraction device” as required by
claims 1–8. Prelim. Resp. 14–18. We are unpersuaded by this contention.
As discussed above, we do not construe the recitation of “endoscopic” in the
preamble as a structural limitation. Moreover, even if considered a
limitation, Patent Owner has not convinced us on this record that Petitioner’s
explanation as to why the Tsugita device or any of the SME Prior Art
devices would satisfy the requirements of an “endoscopic stone-extraction
device” is incorrect. Contrary to Patent Owner’s contention, Petitioner’s
expert Dr. Wagoner has explained that “it would be obvious for a person of
IPR2016-00713 Patent 6,551,327 B1
18
ordinary skill in the art to use the device disclosed in Tsugita as ‘an
endoscopic stone-extraction device’ as required by the preamble of Claim
1.” Ex. 1028, ¶ 87. Dr. Wagoner further explains that “stone extractors [as
described in the SME Prior Art] are percutaneous (endoscopic) minimally
invasive devices.” Id. ¶ 113. Thus, we determine that Petitioner has shown
a reasonable likelihood of prevailing with respect to this patentability
challenge.
2. Obviousness Based on Leslie in View of any of Tsugita, Bates II, or Bates IV
Petitioner asserts that claims 1–8 are also obvious over Leslie in view
of any of Tsugita, Bates II, or Bates IV. Specifically, with respect to claim
1, Petitioner asserts that Leslie discloses each of the limitations of Claim 1
of the ’327 Patent except for a basket comprised of a “set of longitudinal
basket filaments radiating from the first end portion of the support filament
and a set of lateral basket filaments extending between the longitudinal
basket filaments,” with the lateral filaments positioned primarily in the
stone-retention region. Pet. 36–37. Petitioner asserts that the prior art in
2001 disclosed several examples of baskets with lateral and longitudinal
filaments in their stone retention regions, including Tsugita, Bates II and
Bates IV. Id. at 37. Petitioner contends that the skilled artisan would have
been motivated generally to combine Leslie with any of Tsugita, Bates II, or
Bates IV because “prior art patents routinely (1) disclosed devices with
baskets used to remove objects from both blood vessels and the urinary tract
system, or (2) cited to prior art in both areas.” Id. at 38 (citing Ex. 1015,
3:9–16; Ex. 1023, 1:7–13). On a more specific level, Petitioner contends
that a skilled artisan “would have been motivated to combine Leslie with
IPR2016-00713 Patent 6,551,327 B1
19
any of Tsugita, Bates II or Bates IV to solve the problem of entrapping
smaller-sized stones and preventing them from becoming dislodged from the
basket.” Id. Petitioner also cites to the Wagoner Declaration (Ex. 1028) as
support for these motivations.
With respect to dependent claim 2, Petitioner asserts that Leslie
discloses a concave surface meeting the claim’s requirements, as shown in
Figure 8. Id. at 39–40. Petitioner further asserts that the size requirements
of dependent claims 3, 4, and 6 would have been obvious because “[i]t was
well known in 2001 that the diameter of fragmented kidney stones ranged
from 2–10 mm,” and because “[i]t was also well known that the openings in
a basket or filter could be designed to capture ‘particles of a targeted size.’”
Id. at 40 (citing Ex. 1003, 8:59–61; Ex. 1007, 8:59–65; Ex. 1028, ¶¶ 186–
193). Petitioner also asserts that the retrieval basket taught by Leslie meets
the requirements of dependent claims 5 and 7. Id. at 41 (citing Ex. 1004,
6:4–10, Fig. 4). Finally, Petitioner asserts that “Leslie discloses a device
that has a base (grip) (13) and a slider (14) that the physician can move back
and forth in order open and close the basket,” thereby meeting the
requirements of dependent claim 8. Id. at 41 (citing Ex. 1004, 4:50–54,
4:59–63, 5:7–13, 5:60–66).
Based on the current record, including the arguments and claim charts
presented with the Petition, we preliminarily agree with Petitioner’s
contention that claims 1–8 would have been obvious over Leslie in view of
any of Tsugita, Bates II, or Bates IV. The only argument with respect to this
challenge presented in Patent Owner’s Preliminary Response is that the
Petition fails to show that the combination discloses references discloses “an
endoscopic stone-extraction device” as required by claims 1–8, which is
IPR2016-00713 Patent 6,551,327 B1
20
similar to the argument Patent Owner makes with respect to the challenge
based on Tsugita in view of the SME Prior Art. Prelim. Resp. 18–20. We
are unpersuaded by this contention for the reasons discussed above. Thus,
we determine that Petitioner has shown a reasonable likelihood of prevailing
with respect to this patentability challenge.
3. Obviousness Based on Bates I in View of either Tsugita or Bates IV
Petitioner asserts that claims 1–8 are also obvious over Bates I in view
of either Tsugita or Bates IV. As noted above, Bates I teaches a surgical
extractor with a similar structure and manner of operation to the device
disclosed in Leslie. Furthermore, Petitioner asserts that “a person of
ordinary skill in the art in 2001 would have had the same general and
specific motivations to combine Bates I with either Tsugita or Bates IV that
he had to combine Leslie with the same references.” Pet. 47. Based on the
current record, including the arguments and claim charts presented with the
Petition, we preliminarily agree with Petitioner’s contention that claims 1–8
would have been obvious over Bates I in view of either Tsugita or Bates IV.
Patent Owner’s argument regarding this challenge is similar to the
arguments presented for Petitioner’s other patentability challenges, and we
find that argument unpersuasive for same reasons. Prelim. Resp. 21–23.
Accordingly, for the reasons discussed above, we determine that Petitioner
has shown a reasonable likelihood of prevailing with respect to this
patentability challenge.
III. CONCLUSION
For the foregoing reasons, we determine that Petitioner has
demonstrated that the information presented in the Petition shows that there
IPR2016-00713 Patent 6,551,327 B1
21
is a reasonable likelihood that Petitioner would prevail in proving the
unpatentability of claims 1–8 based on the challenges presented in the
Petition.
At this stage of the proceeding, the Board has not made a final
determination as to the patentability of any challenged claim or any
underlying factual and legal issues.
IV. ORDER
Accordingly, it is:
ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes
review is hereby instituted as to claims 1–8 of U.S. Patent No. 6,551,327 B1
based on the following grounds of unpatentability:
A. Claims 1–8 under 35 U.S.C. § 103(a) as obvious over Tsugita
in view of any of the “SME Prior Art” references (i.e., Leslie,
Bates I, Bates II, the Boston Scientific Microvasive Publication,
or the Cook Publications);
B. Claims 1–8 under 35 U.S.C. § 103(a) as obvious over Leslie in
view of any of Tsugita, Bates II, or Bates IV;
C. Claims 1–8 under 35 U.S.C. § 103(a) as obvious over Bates I in
view of either Tsugita or Bates IV.
FURTHER ORDERED that inter partes review commences on the
entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
§ 42.4, notice is hereby given of the institution of a trial; and
FURTHER ORDERED that the trial is limited to the grounds of
unpatentability listed above, and no other grounds of unpatentability are
authorized for inter partes review.
IPR2016-00713 Patent 6,551,327 B1
22
PETITIONER: Melissa A. Anyetei, [email protected] Chandra Critchelow, [email protected] Mayer Brown LLP PATENT OWNER: Albert B. Deaver, Jr., Esq., [email protected] Jeffrey A. Andrews, Esq., [email protected] Bruce J. Cannon, Esq., [email protected] SUTTON MCAUGHAN DEVER PPLC