`Tel: 571-272-7822
`
`
`Paper 92
`Entered: December 28, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`COOK GROUP INCORPORATED
`and
`COOK MEDICAL LLC,
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner.
`_______________
`
`Case IPR2017-00440
`Patent 9,271,731 B2
`_______________
`
`
`Before JAMES T. MOORE, JAMES A. TARTAL,
`and ROBERT L. KINDER, Administrative Patent Judges.
`
`KINDER, Administrative Patent Judge.
`
`
`
`
`FINAL WRITTEN DECISION AND
`ORDER ON MOTION TO AMEND
`
`Inter Partes Review
`35 U.S.C. §§ 316(d), 318(a) and 37 C.F.R. §§ 42.73, 42.121
`
`
`
`
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`IPR2017-00440
`Patent 9,271,731 B2
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`Cook Group Incorporated and Cook Medical LLC (“Petitioner”) filed
`a Petition (Paper 1, “Pet.”) to institute an inter partes review of claims 1–20
`of U.S. Patent No. 9,271,731 B2 (Ex. 1033, “the ’731 patent”). Boston
`Scientific Scimed, Incorporated (“Patent Owner” or “BSSI”) filed a
`Preliminary Response (Paper 6, “Prelim. Resp.”).
`Applying the standard set forth in 35 U.S.C. § 314(a), which requires
`demonstration of a reasonable likelihood that Petitioner would prevail with
`respect to at least one challenged claim, we issued a Decision to Institute an
`inter partes review of claims 1–3, 10–16, and 18 of the ’731 patent, but not
`under all challenged claims or grounds. Paper 7, 27–28 (“Dec.”).
`Patent Owner subsequently filed a Patent Owner Response (Paper 18,
`“PO Resp.”) and Petitioner filed a Reply (Paper 31, “Pet. Reply”).
`Patent Owner also filed a Contingent Motion to Amend (Paper 17,
`“Amend Mot.”), subsequently followed by a Supplemental Brief in Support
`of Patent Owner’s Contingent Motion to Amend (Paper 21). Petitioner filed
`an opposition (Paper 32, “Amend. Opp.”), to which Patent Owner replied
`(Paper 41, “Reply to Opp.”). Petitioner then filed a Sur-Reply in Support of
`their Opposition to Patent Owner’s Motion to Amend (Paper 48 “Amend.
`Sur-Reply”).
`Patent Owner filed a Motion to Exclude (Paper 45) certain evidence
`submitted by Petitioner, to which Petitioner filed an Opposition (Paper 52),
`and Patent Owner filed a Reply (Paper 66).
` Petitioner also filed a Motion to Exclude (Paper 60) certain evidence
`submitted by Patent Owner, to which Patent Owner filed an Opposition
`(Paper 65).
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`A combined oral hearing with Case IPR2017-00435 was held
`April 19, 2018, and a transcript of the hearing is included in the record
`(Paper 69, “Tr.”). A second oral hearing was conducted on September 17,
`2018 (Paper 91, Tr. 2”).
`On April 24, 2018, the Supreme Court held that a decision to institute
`under 35 U.S.C. § 314 may not institute on fewer than all claims challenged
`in the petition. SAS Inst. Inc. v. Iancu, 138 S.Ct. 1348, 1359–60 (2018). On
`April 26, 2018, the Office issued Guidance on the Impact of SAS on AIA
`Trial Proceedings, which states that “if the PTAB institutes a trial, the PTAB
`will institute on all challenges raised in the petition.” https://www.uspto.gov/
`patents-application-process/patent-trial-and-appeal-board/trials/guidance-
`impact-sas-aia-trial. Subsequently, on May 3, 2018, we issued an Order
`modifying the Decision on Institution “to institute on all of the challenged
`claims and all of the grounds presented in the Petition.” Paper 68, 1.
`Pursuant to our authorization, the Parties thereafter filed a “Joint
`Motion to Limit the Proceeding” (Paper 74), requesting that we limit the
`proceeding to a subset of the instituted grounds and claims in the Petition, as
`identified in the motion. Paper 74, 1–2. On June 15, 2018, we issued a
`Decision (Paper 75), accepting the Parties’ joint proposal to limit the
`proceeding “to those claims and grounds as set forth in Paper 74, 1–2.”
`Paper 75, 2. The “Asserted Grounds” section below reflects the claims and
`grounds agreed upon by the Parties and addressed in our Decision to Limit
`the Proceeding.
`Based on the addition of grounds and claims to the proceeding, we
`authorized additional briefing. Paper 73 (also recognizing six month
`extension under 37 C.F.R. § 42.100(c)). On June 29, 2018, Patent Owner
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`filed a Supplemental Response. Paper 77 (“Supp. Resp.”). Petitioner filed a
`Supplemental Reply. Paper 79 (“Supp. Reply”). Patent Owner then filed a
`Sur-Reply. Paper 88 (“Supp. Sur-Reply”).
`Patent Owner filed a second Motion to Exclude (Paper 81), which
`sought to exclude certain evidence submitted by Petitioner, to which
`Petitioner filed an Opposition (Paper 85), and Patent Owner thereafter filed a
`Reply (Paper 86).
`We have jurisdiction under 35 U.S.C. § 6. This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a). For the reasons that
`follow, we determine that Petitioner has shown by a preponderance of the
`evidence that claims 1–4, 6, 7, 10–16, 18, and 20 are unpatentable.
`Petitioner has not shown by a preponderance of the evidence that claims 5
`and 8 are unpatentable
`We address the Parties’ motions to exclude as set forth below.
`Additionally, we deny Patent Owner’s Contingent Motion to Amend as the
`proposed amended claims are unpatentable.
`
`
`I. BACKGROUND
`A. The ’731 Patent (Ex. 1033)
`The ’731 patent is titled “Device and Method for Through the Scope
`Endoscopic Hemostatic Clipping,” and claims an apparatus and method for
`capturing tissue. Ex. 1033, [54], 15:36–17:15. The claimed “invention
`relates to compression clips, and more specifically, to compression clips
`used to cause hemostasis of blood vessels located along the gastrointestinal
`tract delivered to a target site through an endoscope.” Id. at 1:24–27. As
`explained by the ’731 patent, the clips stop internal bleeding by applying
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`sufficient constrictive forces to blood vessels so as to limit or interrupt blood
`flow to achieve “hemostasis.” Id. at 2:32–38, 2:62–66. Embodiments of the
`invention include “a clip” with “clip arms,” and a “control wire” for moving
`the clip between open and closed configurations. Id. at 16:24–42. In
`addition, the medical device claims describe an “opening element” for
`urging the clip arms into the open configuration, and the method claim
`describes use of the control wire to “move the first and second clip arms
`away from one another to the open tissue receiving configuration.” Id. at
`15:37–17:15.
`The ’731 patent describes “an arrangement for closing the clip and for
`reversing the closing process to reopen the clip after closure has begun.” Id.
`at 2:64–66. As described, certain
`[e]mbodiments of the invention may include a lock arrangement
`for locking the clip closed; a control wire connected to the clip
`and able to be disconnected from the clip; an axially rigid sheath
`enclosing the control wire and communicating a compressive
`force opposing a tensile force of the control wire.
`
`Id. at 2:66–3:7. Other elements help “close and lock the clip and to
`uncouple the control wire from the clip.” Id. One advantage mentioned in
`the Specification is “[t]he devices ability to repeatedly open and close the
`clip until the desired tissue pinching is accomplished will lead to a quicker
`procedure, requiring less clips to be deployed, with a higher success rate.”
`Id. at 3:9–13.
`
`B. Illustrative Claims
`Claims 1 and 20 are illustrative of the claims at issue:
`1.
`A medical device, comprising:
`a clip including first and second clip arms, the clip being movable
`between an open tissue receiving configuration in which the first
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`and second arms are separated from one another by a distance
`selected
`to
`receive
`tissue
`therebetween and a closed
`configuration in which the first and second arms are moved
`inward to capture the tissue received therebetween; and
`an opening element engaging inner walls of the first and second
`clip arms, the opening element urging the first and second clip
`arms away from one another into the open tissue-receiving
`configuration, wherein the opening element is movable between
`an expanded configuration and a retracted configuration to
`correspond to a movement of the clip between the open tissue
`receiving configuration and the closed configuration.
`Ex. 1033, 15:37–52.
`20. A method for capturing tissue, comprising:
`inserting a medical device comprising a clip having first and
`second clip arms to a target tissue site, the clip including an
`opening element engaging inner walls of the first and second clip
`arms and urging
`the clip
`to an open
`tissue receiving
`configuration;
`moving a control wire coupled to a proximal end of the clip
`distally to move the first and second clip arms away from one
`another to the open tissue receiving configuration;
`moving the control wire proximally to move the first and second
`clip arms toward one another to a closed tissue capturing
`configuration; and
`applying a proximal tensile force exceeding a threshold level to
`the control wire to separate the control wire from the clip.
`Id. at 17:1–15. Independent claim 12 is similar in scope to claim 1, but
`further requires “a control wire coupled to a proximal end of the clip and
`operable to move the clip between the open and closed configurations.” Id.
`at 16:40–42.
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`C. Related Proceedings
`The ’731 patent is the subject of Boston Scientific Corp. v. Cook
`Group Inc., Civil Action No. 1:15-cv-00980-LPS-CJB (D. Del). Pet. 1;
`Paper 3, 2. Patent Owner identifies the following petitions challenging the
`patentability of related patents:
`1. IPR2017-00131 (U.S. Patent No. 8,685,048);
`2. IPR2017-00132 (U.S. Patent No. 8,685,048);
`3. IPR2017-00133 (U.S. Patent No. 8,709,027);
`4. IPR2017-00134 (U.S. Patent No. 8,709,027);
`5. IPR2017-00135 (U.S. Patent No. 8,974,371); and
`6. IPR2017-00435 (U.S. Patent No. 9,271,731).
`Paper 3, 2–3.
`
`D. References Relied Upon
`Petitioner relies upon the following prior art references:
`U.S. Patent No. 5,749,881 issued on May 12, 1998 (“Sackier”)
`(Ex. 1008);
`U.S. Patent No. 5,843,000 issued on Dec. 1, 1998 (“Nishioka”)
`(Ex. 1005); and
`Japanese Unexamined Patent Application Publication No. 60-103946,
`published on June 8, 1995 (“Shinozuka”) (Ex. 1009; certified translation at
`Ex. 1042).
`Petitioner also relies on
`1. the Declaration of Mark A. Nicosia, Ph.D. (Ex. 1041),
`2. Dr. Nicosia’s Declaration in support of Petitioner’s Reply (Ex.
`1096),
`3. Dr. Nicosia’s Declaration in support of its Opposition to Patent
`Owner’s Motion to Amend (Ex. 1097),
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`4. Dr. Nicosia’s Declaration in Support of Petitioner’s Sur-Reply to
`Their Opposition to Motion to Amend (Ex. 1101), and
`5. Dr. Nicosia’s Declaration in Support of Petitioner’s Supplemental
`Reply (Ex. 1110).
`Patent Owner relies on:
`1. the Declaration of Jeffrey Vaitekunas, Ph. D. (Ex. 2017) in support
`of its Response,
`2. Dr. Vaitekunas’s Declaration in support of Reply to Patent
`Owner’s Motion to Amend (Ex. 2095), and
`3. Dr. Vaitekunas’s Declaration in support of Patent Owner’s
`Supplemental Response (Ex. 2103).
`E. The Asserted Grounds
`Pursuant to our Institution Decision (Paper 7) and our Decision on the
`Parties’ Joint Motion to Limit Proceeding (Paper 78), the following
`challenges to the patentability of the ’731 patent are before us for
`consideration:
`Reference(s)
`Sackier
`Sackier
`Nishioka
`Nishioka or Nishioka and
`Sackier
`Shinozuka and (Sackier or
`Nishioka)
`
`1 The relevant sections of the Leahy-Smith America Invents Act (“AIA”),
`Pub. L. No. 112–29, 125 Stat. 284 (Sept. 16, 2011), took effect on March 16,
`2013. Because the application from which the ’731 patent issued was filed
`before that date, our citations to Title 35 are to its pre-AIA version.
`
`Basis Claim(s) Challenged
`§ 1021 1, 2, 4, 6–9, 12, 13, and 20
`§ 103
`3, 5, 10, 11, and 14–19
`§ 102
`1–3, 10–16, and 18
`§ 103
`1–3, 10–16, and 18
`
`§ 103
`
`1–4, 6–10, 12–14, and 20
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`II.
`CLAIM CONSTRUCTION
`Petitioner identifies several terms for construction. Pet. 11–17. These
`terms include: “opening element,” “engaging inner walls of the first and
`second clip arms,” “movable between an expanded configuration and a
`retracted configuration to correspond to a movement of the clip,” and “link
`arms are axially aligned with one another.” Id. Patent Owner identifies the
`following terms for construction: “clip,” “inner walls of the . . . clip arms,”
`and “coupled to.” PO Resp. 20–25.
`Claims in an inter partes review are given the “broadest reasonable
`construction in light of the specification of the patent in which [they]
`appear[].” 37 C.F.R. § 42.100(b) (2016); Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131, 2136 (2016). Below, we construe only two terms that are
`necessary to address for purposes of this Final Decision.
`A.
`“engaging inner walls of the first and second clip arms”
`Claim 1 requires, in relevant part, “an opening element engaging inner
`walls of the first and second clip arms.” Ex. 1033, 15:45–46. Claim 12 has
`the same limitation. Id., 16:32–33. Method claim 20 similarly requires “the
`clip including an opening element engaging inner walls of the first and
`second clip arms.” Id., at 17:3–5.
`The Parties generally agree that the term “engaging” as used in
`“engaging inner walls” means contacting, but without requiring a physical
`connection. See, e.g., Pet. 15 (interpreting engaging as contacting, but
`without a physical connection), PO Resp. 21 (offering no rebuttal to
`“engaging” as contacting). Petitioner contends that “‘engaging inner walls’
`simply requires that the opening element ‘contact[]’ the inner walls, without
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`requiring a ‘physical connection.’” Pet. 15 (quoting Ex. 1039, 32 (Patent
`Owner’s claim construction position from district court)). Petitioner also
`notes “that ‘engaging inner walls of the first and second clip arms’ requires
`that the ‘opening element’ is ‘positioned between the clip arms and of
`sufficient size to be able to engage the clip arms.’” Id. (quoting Ex. 1035,
`3).
`
`The Parties’ dispute focuses on what is meant by the term “inner
`walls.” See PO Resp. 21–22 (construing “inner walls”); Pet. Reply 5
`(“‘inner walls’ refers both to interior surfaces, as well as exterior surfaces”).
`Below, we discuss each Parties’ position related to the “inner walls”
`limitation and provide our determination for the proper meaning of this
`limitation.
` “Patent Owner proposes that the Board construe ‘inner walls of the
`first and second clip arms’ to mean ‘the exterior surfaces of the first and
`second clip arms that are radially inward-facing relative to the longitudinal
`axis of the clip.’” PO Resp. 22. Patent Owner, relying on the testimony of
`Dr. Vaitekunas, contends its interpretation is consistent with both the
`intrinsic evidence and how a person of ordinary skill in the art would have
`interpreted the phrase in view of the ’731 patent. Id. (citing Ex. 2017 ¶ 35).
`Patent Owner relies on Figures 10A and 10B, depicted below, which
`“show flexible linkage 1002 contacting the radially inward-facing surfaces
`of clip legs 1001.” Id.
`
`
`2 We adopt the page numbering added by Petitioner at the bottom right hand
`corner of Exhibits 1039 and 1035.
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`Figures 10A and 10B of the ’731 patent show enlarged partial views of one
`embodiment of the compression clip with flexible linkage 1002 and pill
`1003 used to lock clip legs 1001. Ex. 1033, 8:61–64.
`Patent Owner also relies on Figures 8A, 8B and 15A–C of the ’731 patent,
`which purportedly “show an opening element contacting the radially inward-
`facing walls of the clip arms.” PO Resp. 23.
`
`Patent Owner also alleges that its proposed construction is “consistent
`with Petitioners’ proposed construction of ‘opening element,’” which
`requires a structure that “‘engages the inner walls of the clip arms and urges
`them away from one another.’” Id. (quoting Pet. 14). According to Patent
`Owner, the opening element described and shown in the Specification
`engages the radially inward-facing walls of the clip arms. Id.
`Patent Owner relies on other portions of the ’731 patent in support of
`its interpretation of the “inner walls” limitation. For example, Patent Owner
`cites Figures 20A–C, and notes that the structure designated as 2004 is an
`“inner sleeve,” which is radially inward of sheath 2003. PO Resp. 24
`(quoting Ex. 1033, 13:30–33). Patent Owner notes that this structure “is
`described as having ‘female threads (not shown) on its inside diameter,’
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`which would be the diameter facing radially inwards towards the
`longitudinal axis of the clip, as shown in Figures 20B and 20C.” Id.
`(quoting Ex. 1033, 13:30–48). Patent Owner points out that “[b]y contrast,
`the specification describes that clip 2001 ‘is characterized by male threads
`2002 on its outer surface,’” which “[a]s seen in Figures 20B and 20C, the
`‘outer surface’ is a surface that faces radially outward with respect to the
`longitudinal axis of the clip.” Id. (quoting Ex. 1033, 13:27–28). Finally,
`Dr. Vaitekunas testifies that a person of ordinary skill in the art would not
`understand “inner walls” to refer to any walls other than the radially inward-
`facing walls of the clip arms. PO Resp. 24 (citing Ex. 2017 ¶ 35).
`In its Reply, Petitioner contends that a person of ordinary skill “would
`understand that ‘inner walls’ refers both to interior surfaces, as well as
`exterior surfaces.” Pet. Reply 5 (citing Ex. 1096 ¶¶ 12–13). Petitioner
`similarly argues that a person of ordinary skill “also would understand that
`‘inner walls’ refers to surfaces that are radially-inward facing, as well as
`surfaces that are not radially-inward facing, relative to a longitudinal axis of
`the clip.” Id. Petitioner relies on Figures 10A and 10B of the ’731 patent to
`support the proposition that it is “unclear what shape clip legs 1001 have in
`cross-section (round, rectangular, etc.) and, if not round, precisely what
`surface(s) linkage 1002 engages.” Pet. Reply 4.
`
`Based on the final record before us, we find Patent Owner’s proposed
`construction more persuasive because it is grounded in, and most consistent
`with, the Specification of the ’731 patent. Contrastingly, Petitioner does not
`offer a specific interpretation of “inner walls” and its arguments are
`generally based on extrinsic evidence, including claim charts from the
`related district court litigation (Pet. 15), arguments from related proceedings
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`(Pet. Reply 3), and the prior art reference (Nishioka) relied on to challenge
`the claims (id. at 3–4).
`Petitioner criticizes the Patent Owner’s position but provides no
`express interpretation of “inner walls of the first and second clip arms”;
`instead, Petitioner argues why Patent Owner’s proposed construction is
`wrong. Pet. Reply 4–5. Dr. Nicosia does not expressly define or otherwise
`persuasively explain the definition of “inner walls” in his declarations either.
`The Parties each address whether Figures 20A–C of the ’731 patent,
`and the corresponding descriptions, support Patent Owner’s proposed
`interpretation of “inner walls.” See PO Resp. 24; Pet. Reply 2–4.
`Examining this intrinsic evidence, the term “outer surface” is used in the
`’731 patent to characterize the male threads 2002 on the outer surface of the
`clip found in Figure 20B. Figure 20B is reproduced below:
`
`
`Figure 20 B is an enlarged partial cross-sectional diagram of a clip.
`It is apparent that “outside surface” means what it says, the surface that faces
`radially outwardly from the centerline of the clip. Ex. 1001, Ex. 1033,
`13:27–48. The Specification goes on to describe that the “inner sleeve 2004
`has female threads (not shown) on its inside diameter.” Id. 13:30–36.
`Although the term “inner surface” does not appear in the Specification, by
`logical extension, an inner surface would be consistent with the inner
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`diameter that faces radially inwardly from a centerline of the clip to engage
`the threads.
`Petitioner’s interpretation of “inner walls” to refer both to interior
`surfaces, as well as exterior surfaces (Pet. Reply 5), would essentially read
`the term out of the claim because any wall surface, regardless of position,
`could therefore be an “inner wall.” Instead, we find Dr. Vaitekunas’s
`testimony more persuasive as to what is meant by an “inner wall:”
`[A] POSITA would not understand the term “inner walls of the
`. . . clip arms” to have a broader meaning encompassing an
`interior portion of the clip via an aperture in the side wall of the
`clip arms, as Petitioners and Dr. Nicosia suggest. In addition, a
`POSITA would not identify the surface on which pin 142 is
`located in Nishioka Embodiment 2 to be an “inner wall,” as
`suggested by the Board in the Institution Decision, as this would
`be inconsistent with the ordinary meaning of “inner walls of the
`. . . clip arms” within the context of the ’731 Patent and its
`specification.
`Ex. 2017 ¶ 35. We find this testimony to be credible and consistent with the
`intrinsic evidence of record.
`Based on the final record before us, “inner walls” are exterior walls
`that face inwardly from a radial centerline of the clip. We therefore interpret
`“inner walls of the first and second clip arms” to mean “the exterior surfaces
`of the first and second clip arms that are inward-facing relative to the
`longitudinal axis of the clip.”
`B.
`“clip”
` The Parties now agree that “clip,” as the term is generally understood,
`and as used in the Specification, means a device having compression legs
`and capable of applying a pinching pressure. “Patent Owner does not
`oppose the Board’s construction.” PO Resp. 21.
`
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`III. ANALYSIS
`A petition must show how the construed claims are unpatentable
`under the statutory ground it identifies. 37 C.F.R. § 42.104(b)(4). Petitioner
`bears the burden of proving unpatentability of the challenged claims, and the
`burden of persuasion never shifts to Patent Owner. Dynamic Drinkware,
`LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To
`prevail, Petitioner must establish the facts supporting its challenge by a
`preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
`A. Principles of Law
`1. Anticipation
`To establish anticipation, each and every element in a claim, arranged
`as recited in the claim, must be found in a single prior art reference. Net
`MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). “To
`anticipate a claim, a prior art reference must disclose every limitation of the
`claimed invention, either explicitly or inherently.” In re Schreiber, 128 F.3d
`1473, 1477 (Fed. Cir. 1997).
`2. Obviousness
`A claim is unpatentable under § 103(a) if the differences between the
`claimed subject matter and the prior art are such that the subject matter, as a
`whole, would have been obvious at the time the invention was made to a
`person having ordinary skill in the art to which said subject matter pertains.
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of
`obviousness is resolved on the basis of underlying factual determinations,
`including: (1) the scope and content of the prior art; (2) any differences
`between the claimed subject matter and the prior art; (3) the level of skill in
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`the art; and (4) where in evidence,3 so-called secondary considerations.
`Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966).
`“To satisfy its burden of proving obviousness, a petitioner cannot
`employ mere conclusory statements. The petitioner must instead articulate
`specific reasoning, based on evidence of record, to support the legal
`conclusion of obviousness.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d
`1364, 1380 (Fed. Cir. 2016). Furthermore, in assessing the prior art, the
`Board must consider whether a person of ordinary skill would have been
`motivated to combine the prior art to achieve the claimed invention. In re
`Nuvasive, Inc., 842 F.3d 1376, 1381 (Fed. Cir. 2016).
`B. Person of Ordinary Skill in the Art
`Petitioner proposes that a person of ordinary skill in the art as of the
`time of the filing of the application that became the ’731 patent would have
`possessed the knowledge and skill of an engineer or similar professional
`with at least an undergraduate degree in engineering, or a physician having
`experience with designing medical devices. Pet. 10 (citing Ex. 1041 ¶ 11).
`Patent Owner does not dispute Petitioner’s proposal, and we adopt it based
`on the final record, as it is consistent with the level of skill evidenced by the
`references.
`C. Claims 1, 2, 4, 6–9, 12, 13, and 20 as Anticipated by Sackier
`Petitioner contends claims 1, 2, 4, 6–9, 12, 13, and 20 are
`unpatentable under 35 U.S.C. § 102, as anticipated by Sackier. Pet. 23–38.
`1. Overview of Sackier (Ex. 1008)
`Sackier is directed to a laparoscopic surgical device that includes a
`
`
`3 The Parties have not introduced evidence of secondary considerations.
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`clamp. Ex. 1008, Abstract. Petitioner relies on the embodiment of
`Figure 17 of Sackier, which is reproduced below.
`
`
`
`
`Petitioner’s Annotated Fig. 174 depicts an axial cross-section views of a
`clamp (Pet. 18); Ex. 1008, 3:60–62.
`The surgical clamp includes a pair of jaws, or clip arms identified above,
`with a spring 152 to bias the jaws to the open position:
`the shaft 58a can be moved relative to the tube 23a to engage the
`slide 47a and move it relative to . . . the jaws 36a, 38a. As noted,
`this axial movement of the slide 47a relative to the jaws 36a and
`38a is accompanied by relative movement of the jaws 36a, 38a
`between the open and closed positions.
`
`Ex. 1008, 10:28–34.
`2. Claims 1, 12, and 20
`Petitioner asserts that Sackier discloses all elements of claims 1, 12,
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`4 We include Petitioner’s annotated figures from Sackier because “Figures
`15–26 of Sackier published without reference numbers, even though Figures
`15–26 with reference numbers were submitted during prosecution.” Pet. 18–
`19, n.5.
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`and 20. Pet. 23–27, 35–38. Each of claims 1 and 12 requires “an opening
`element engaging inner walls of the first and second clip arms, the opening
`element urging the first and second clip arms away from one another,” and
`method claim 20 requires a similar limitation. See Ex. 1033, 15:45–47,
`16:32–34, 17:3–6.
`Petitioner relies on Figures 15–17 as disclosing these limitations, and
`more specifically, “Sackier discloses an opening element (spring 152) urging
`the first and second clip arms away from one another into the open tissue-
`receiving configuration (Figure 17).” Pet. 25. Petitioner acknowledges,
`however, that the disclosed spring 152 in Figures 15–17 of Sackier (the
`claimed opening element) does not engage, or contact, the inner walls.
`See Pet. 26. To address this shortcoming, Petitioner proposes a series of
`modifications to Figures 15–17 based on other distinct embodiments
`disclosed in Sackier. Id.
`First, Petitioner proposes
`that instead of having two pivotal clip arms (jaws 36a, 38a) as
`shown in Figures 15–17, the embodiment depicted in Figures 15–
`17 “can . . . be formed with the jaw 38a in a fixed relationship to
`the supporting structure 34a and the jaw 36a pivotal relative to
`the supporting structure 34a on a hinge 41a in the manner
`previously discussed.”
`
`Id. (quoting Ex. 1008, 9:25–30). Petitioner next proposes using a fixed jaw
`embodiment (Figure 2), “which includes an opening element (spring 52)
`engaging the inner walls of the first and second clip arms and urging the clip
`arms away from one another into an open tissue-receiving configuration.”
`Id. The modified embodiment would then adopt spring 52 from Figure 2.
`Id. Petitioner contends that spring 152 is just “one ‘example’ of what could
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`be used to bias the jaws 36a and 38a to the open position, confirming that
`the embodiment shown in Figures 15–17 includes spring 52 as an alternative
`to spring 152.” Id. at 27.
`Patent Owner contends that Sackier does not disclose a medical
`device with “an opening element engaging inner walls of the first and
`second clip arms” as required by each independent claim. Supp. Resp. 21.
`Patent Owner argues that the alleged “opening element” identified as springs
`152 do not engage the inner walls as depicted in Patent Owner’s annotated
`Figure 15 below.
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`
`Patent Owner’s annotated Figure 15 of Sackier (Supp. Resp. 21) showing
`location of spring 152 and inner surfaces of jaws 36a, 38a.
`Patent Owner takes issue with Petitioner’s selective picking and
`choosing features from distinct embodiments, such as spring 52 from
`another embodiment, in the anticipation analysis of claims 1, 12, and 20.
`Supp. Resp. 22–23. Petitioner alleges that such a mixing of embodiments is
`improper for anticipation. Id.
`We agree that spring 152 does not contact the inner surface of jaws
`36a and 36b in Figure 15. However, Petitioner asserts that Dr. Nicosia
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`explained how Sackier’s “labeling convention” (using successive lower-case
`letters to identify successive embodiments) teaches substituting the
`Embodiment 2 clamp/clamp applier for the clamp applier illustrated in
`Figures 11–14. Supp. Reply 18; Ex. 1008 9:5–15. We have carefully
`considered Dr. Nicosia’s testimony and Petitioner’s supplemental briefing.
`We observe that spring 52 in the second Sackier embodiment does
`appear to contact the inner surface of the jaws and act to drive them apart.
`Ex. 1008, Figure 2. And we are now persuaded that there is an unillustrated
`embodiment in Sackier of Figure 2 where both legs are pivotable. Ex. 1008,
`5:9–12. (“In an unillustrated embodiment (not shown), both of the jaws 36
`and 36 are pivotable along the supporting structure 34 and include bevel
`surfaces, such as surface 45, which are engagable by the screw 47 to open
`and close the jaws 36, 38.”).
`We are not persuaded that the two different embodiments are
`necessarily described as (or one of ordinary skill in the art would regard
`them as) having interchangeable components, principally because they
`operate on different principles to open and close the legs. Sackier Figure 2
`utilizes a spring between the legs that drives the legs out as a screw and
`beveled surface exert inward force.
`The Sackier Figure 15–17 embodiment works on a different principle,
`with a spring at the pivot point 152 biasing the legs outwardly, an external
`sleeve holding the legs inwardly and releasing as the clip slides relative to
`the sleeve. This is not the same mechanism as a stationary screw and bevel.
`Patent owner argues persuasively that:
`Regardless of whether the embodiment of Figure 2 has one
`fixed jaw or two pivotal jaws, the flaw in Petitioners’ argument
`is the assumption that spring 52 from Figure 2 is disclosed as an
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`alternative to spring 152 in the embodiment of Figures 15-17. It
`is not disclosed as such, and the allegedly “parallel descriptions
`of illustrated and alternative embodiments” (Paper 79 at 9) does
`not change the analysis. Numerous elements identified with the
`same numeral differ between the two embodiments, including for
`example, screw 47 in embodiment of Figure 2 and slide 47a in
`the embodiment of Figures 15-17. That the embodiment of
`Figures 15-17 designates its spring 152 differently from the
`numeric designation of the spring in Figure 2 drives home the
`point that Sackier disclosed different structures in different
`embodiments.
`PO Sur-Reply, 1–2.
`We conclude that Patent Owner has the better side of this argument.
`Even though Dr. Nicosia testifies that the embodiments can be interchanged
`(Ex. 1110 ¶¶ 9–11) we understand that the bas