Transcript
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[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

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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

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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:

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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:

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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:

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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”).

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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).

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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

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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

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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:

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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

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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.

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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:

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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:

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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

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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–

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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

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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

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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

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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

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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.

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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


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