Trials@uspto.gov
`Tel: 571-272-7822
`
`
`Paper 94
`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 IPR2017-00435
`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
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`Paper 94
`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 IPR2017-00435
`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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`IPR2017-00435
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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 7, “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 1–4, 6–18, and 20 of the ’731 patent, but not
`under all challenged claims or grounds. Paper 8, 20 (“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 45, “Reply to Opp.”). Petitioner then filed a Sur-Reply in Support of
`the Opposition to Patent Owner’s Motion to Amend (Paper 52, “Amend.
`Sur-Reply”).
`Patent Owner filed a Motion to Exclude (Paper 48) certain evidence
`submitted by Petitioner, to which Petitioner filed an Opposition (Paper 56),
`and Patent Owner filed a Reply (Paper 61).
` Petitioner also filed a Motion to Exclude (Paper 64) certain evidence
`submitted by Patent Owner, to which Patent Owner filed an Opposition
`(Paper 69).
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`
`A combined oral hearing with Case IPR2017-00440 was held
`April 19, 2018, and a transcript of the hearing is included in the record
`(Paper 72, “Tr.”). A second oral hearing was conducted on September 17,
`2018 (Paper 93, 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.”1 Subsequently, on
`May 7, 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 71, 1.
`Pursuant to our authorization, the parties thereafter filed a “Joint
`Motion to Limit the Proceeding” (Paper 77), requesting that we limit the
`proceeding to a subset of the instituted grounds and claims in the Petition, as
`identified in the motion. Paper 77, 1–2. On June 15, 2018, we issued a
`Decision (Paper 78), accepting the Parties’ joint proposal to limit the
`proceeding “to those claims and grounds as set forth in Paper 77, 1–2.”
`Paper 78, 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 76 (also recognizing six month
`
`1 Available at: https://www.uspto.gov/ patents-application-process/patent-
`trial-and-appeal-board/trials/guidance-impact-sas-aia-trial.
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`extension under 37 C.F.R. § 42.100(c)). On June 29, 2018, Patent Owner
`filed a Supplemental Response. Paper 80 (“Supp. Resp.”). Petitioner filed a
`Supplemental Reply. Paper 81 (“Supp. Reply”). Patent Owner then filed a
`Sur-Reply. Paper 90 (“Supp. Sur-Reply”).
`Patent Owner also filed a second Motion to Exclude (Paper 83), which
`sought to exclude certain evidence submitted by Petitioner, to which
`Petitioner filed an Opposition (Paper 87), and Patent Owner thereafter filed a
`Reply (Paper 88).
`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 not shown by a preponderance of
`the evidence that claims 1–4, 6–18, and 20 are unpatentable in this
`proceeding.
`We address the Parties’ motions to exclude as set forth below.
`Additionally, we deny Patent Owner’s Contingent Motion to Amend as
`moot.
`
`
`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 clamping
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`together the edge of a wound to achieve “hemostasis.” Id. at 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,” as well as
`other elements to help “close and lock the clip and to uncouple
`the control wire from the clip.
`Id. at 2:66–3:7. One advantage mentioned in the Specification is that “[t]he
`device’s 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 Claim
`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
`and second arms are separated from one another by a distance
`selected
`to
`receive
`tissue
`therebetween and a closed
`
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`
`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.
`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;
`
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`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. IPR2017-00440 (U.S. Patent No. 9,271,731).
`Paper 3, 2–3.
`
`D. References Relied Upon
`Petitioner relies upon the following prior art reference: U.S. Patent
`No. 5,626,607 issued on May 6, 1997 (“Malecki”) (Ex. 1003).
`Petitioner also relies on:
`1. the Declaration of Mark A. Nicosia, Ph.D. (Ex. 1037),
`2. Dr. Nicosia’s Declaration in Support of Petitioner’s Reply (Ex.
`1095),
`3. Dr. Nicosia’s Declaration in Support of Petitioner’s Opposition to
`Patent Owner’s Motion to Amend (Ex. 1097), and
`4. Dr. Nicosia’s Declaration in Support of Petitioner’s Sur-Reply to
`Patent Owner’s Motion to Amend (Ex. 1101).
`Patent Owner relies on:
`1. the Declaration of Jeffrey Vaitekunas, Ph. D. in support of its
`Response (Ex. 2010), and on
`2. Dr. Vaitekunas’s Declaration in support of its Motion to Amend
`(Ex. 2094).
`
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`E. The Instituted Grounds
`Pursuant to our Institution Decision (Paper 8), our Decision
`Modifying the Institution Decision (Paper 71), and our Decision granting the
`Parties’ Joint Motion to Limit Proceeding (Paper 78), the following
`challenges to the patentability of the ’731 patent are before us for
`consideration:
`Basis
`Reference(s)
`Malecki (Embodiment #1)2 § 1023
`Malecki (Embodiment #1)
`§ 103
`Malecki (Embodiment #2)
`§ 102
`Malecki (Embodiment #2)
`§ 103
`
`Claim(s) Challenged
`1–4, 6, 9–18, and 20
`1–4, 6–18, and 20
`1, 2, 4, 10, 12, and 13
`3, 6–9, 14, and 20
`
`
`
`II.
`CLAIM CONSTRUCTION
`Petitioner identifies several terms for construction. Pet. 11–17. As an
`initial matter, Petitioner’s support for its proposed interpretation of each
`term is lacking because Petitioner’s only cited evidence is Patent Owner’s
`claim construction position from the related district court litigation. Patent
`Owner challenges two limitations for interpretation. PO Resp. 7–8.
`
`
`2 Petitioner identifies and relies upon specific embodiments within the
`overall disclosure of Malecki referred to as Embodiment #1 (Fig. 28) and
`Embodiment #2 (Figs. 25–27). Pet. 9, n.3. For purposes of our analysis, we
`adopt Petitioner’s identification.
`3 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 ’371 patent issued was filed
`before that date, our citations to Title 35 are to its pre-AIA version. See
`Pet. 8, n.2.
`
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`
`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 the one claim
`limitation that is necessary to resolve the controversy before us.
`“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 a physical connection.
`See, e.g., Pet. 15 (interpreting engaging as contacting, but without a physical
`connection), PO Resp. 8–9 (offering no rebuttal to “engaging” as
`contacting). Petitioner contends that “‘engaging inner walls’ simply requires
`that the opening element ‘contact[]’ the inner walls, without requiring a
`‘physical connection.’” Pet. 15 (quoting Ex. 1039, 34 (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. 7, 11–12 (construing “inner walls”); Pet. Reply 5
`
`4 We adopt the page numbering added by Petitioner at the bottom right hand
`corner of Exhibits 1039 and 1035.
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`(“‘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. 11. 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. at 12 (citing Ex. 2010
`¶¶ 42–53).
`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.
`
`
`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.
`
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`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. 12.
`
`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. at 13 (quoting Pet. 13). 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. 13
`(quoting Ex. 1033, 13:30–33). Patent Owner notes that this structure “is
`described as having ‘female threads (not shown) on its inside diameter,’
`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 and also would not understand a pinhole cutout
`to constitute a “wall” of the clip arm. PO Resp. 13 (citing Ex. 2010 ¶¶ 42–
`
`11
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`53).
`
`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. 1095 ¶ 15). 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. (citing Ex. 1095 ¶¶ 14–15). 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 4–5. Petitioner
`then pivots away from discussing the specification of the ’731 patent and
`argues that “[m]ost relevant here,” a person of ordinary skill in the art would
`have understood that the broadest reasonable interpretation of “inner walls”
`at least encompasses the surfaces contacted by Malecki’s opening element
`and, in particular, those surfaces identified and discussed below.” Id.
`
`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
`(Pet. Reply 3), and the prior art reference (Malecki) 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
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`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. See generally Exs. 1037, 1095, and 1109.
`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. 13; 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. 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 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,
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`could therefore be an “inner wall.” Instead, we find Dr. Vaitekunas’s
`testimony more persuasive as to what is meant by an “inner wall:”
`Therefore, it is my opinion that a POSA reading the ’731 patent
`would understand “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.” Petitioners arguments fail to clearly define the term.
`A POSA would not understand an interior pinhole cutout to
`constitute a “wall” of the clip arm. A POSA would understand
`the “walls” of the clip arms to be the exterior surfaces of the clip
`arms. Moreover, a POSA would not understand portions of non-
`radially inward facing walls (i.e., side/lateral walls) below some
`imaginary line to constitute an “inner wall.” Thus, a POSA
`would understand the radially inward facing wall to be the “inner
`wall” of the clip arms.
`Ex. 2010 ¶ 53. 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.”
`
`
`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
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`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
`the art; and (4) where in evidence,5 so-called secondary considerations.
`Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966).
`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
`
`5 The parties have not introduced evidence of secondary considerations in
`this proceeding.
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`with at least an undergraduate degree in engineering, or a physician having
`experience with designing medical devices. Pet. 10 (citing Ex. 1037 ¶ 11).
`Patent Owner does not dispute Petitioner’s proposal, and we adopt it based
`on the final record before us. It is also consistent with the level of skill
`evidenced by the references.
`C. Claims 1–4, 6, 9–18, and 20 as Anticipated by Malecki
`Embodiment #1
`Petitioner contends claims 1–4, 6, 9–18, and 20 are unpatentable,
`under 35 U.S.C. § 102, as anticipated by Malecki Embodiment #1. Pet. 23–
`41.
`
`1. Overview of Malecki (Ex. 1003)
`Malecki is directed to a clamp for clamping a body structure.
`Ex. 1003, Abstract. Petitioner relies on two distinct embodiments of
`Malecki – Embodiment #1 (Figure 28A) and Embodiment #2 (Figures 25–
`27). Pet. 9. For purposes of this ground, Petitioner relies only on
`Embodiment #1, represented by Figure 28A of Malecki, reproduced below.
`
`
`Figure 28a is a side view of a clamp depicting jaws 308C and 310C as part
`of the structure. Ex. 1003, 6:29–30.
`
`16
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`Malecki describes this embodiment as “[c]lamp 304C includes first and
`second jaws 308C, 310C having somewhat outwardly bowed jaw surfaces
`312C, 314C so that they do not touch along their entire surfaces,” and
`further, “[j]aws 308C, 310C are also preferably curved when viewed from
`the side.” Ex. 1003, 17:43–48. Malecki states that “[a]rms 308C, 310C are
`pivotally mounted to opposite ends of a clamp base 396.” Id. at 17:50–51.
`
`Within this embodiment, “connector 402 is coupled to a distal end of
`the shaft 398,” and “[c]onnector 402 is [also] coupled to first and second
`jaws 308C, 310C by links 404, 406 so axial displacement of shaft 398
`moves jaws 308C, 310C between the open, solid line position to the closed,
`dashed line position.” Id. at 17:57–62.
`At issue, and as discussed below in detail, is how and where first and
`second jaws 308C, 310C are connected to links 404, 406 in this
`embodiment.
`2. Discussion of Claims 1, 12, and 20
`Petitioner asserts that Malecki Embodiment #1, alone, discloses all
`elements of claims 1, 12, and 20. Pet. 23–27, 36–37, 40–41. Petitioner’s
`analysis is supported by the testimony of Dr. Nicosia. See Ex. 1037 ¶¶ 31–
`35, 44–47, 54–58. Patent Owner challenges whether Malecki discloses the
`“inner walls of the first and second clip arms” limitation construed above.
`PO Resp. 21.
`According to Petitioner, Malecki Embodiment #1 discloses a medical
`device including a clip with clip arms, and a control wire for opening and
`closing the clip. Pet. 19. Petitioner contends that an opening element urges
`the clip arms away from one another into an open tissue-receiving
`configuration as the control wire is moved distally, as depicted in annotated
`
`17
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`Figures 25 and 28A below. Id.
`
`
`
`Petitioner’s annotated Figures 25 and 28A (Pet. 19) depicting a clip with
`opening element 404 engaging clip arms 308C and 310C.
`Petitioner alleges that Malecki discloses that the same clamp positioner
`(306B of Figure 25) “may be used with each of the clips shown in Malecki
`Embodiments #1 and # 2.” Pet. 20 (citing Ex. 1003, 17:55–57). Thus,
`according to Petitioner, “Malecki Embodiment[] #1 [] also disclose[s] a
`separable link between the control wire and clip, to allow the clip to remain
`in a patient’s body, as shown below.” Id.
`
`Petitioner’s annotated Figures 25 and 28A (Pet. 21) depicting an alleged
`separable link between a control wire and a clip.
`Petitioner argues that “Malecki Embodiment #1 discloses a clip
`
`(clamp 304C) including first and second clip arms (jaws 308C, 310C).” Pet.
`
`18
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`23. Further, according to Petitioner, the clip arms are movable between an
`open tissue receiving configuration depicted in Figure 28A and a closed
`configuration (dashed line position in Figure 28A) in which the first and
`second arms are moved inward to capture the tissue. Id. For the “control
`wire” limitation of claims 12 and 20, Petitioner relies on rotating the drive
`body 346B, which results in the application of a proximal tensile force to the
`control wire (346B, 400, 398) to close the clip (304C), and rotating the drive
`body 346B in the other direction, which results in the application of a
`distally directed force to the control wire to open the clip of Malecki
`Embodiment #1. Pet. 32, 33, 37, 41.
`
`Most relevant for our discussion below, Petitioner identifies the
`claimed “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,” as being
`taught by Malecki Embodiment #1. Id. at 24–25. Specifically, as depicted
`below, “an opening element (links 402, 404, connector 406 (highlighted in
`yellow)) that urges the first and second clip arms (308C, 310C) away from
`one another, from a closed configuration (dashed line position) into the open
`tissue receiving configuration (solid line position).” Id. at 24.
`
`19
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`Petitioner’s annotated Figure 28A (Pet. 25) showing opening element 402,
`404, and 406 highlighted in yellow.
`Petitioner contends that the opening element engages the inner walls of the
`first and second clip arms on two instances. Pet. 25–26. In the first
`instance, links 404, 406 of the opening element engage the inner walls of the
`first and second clip arms (308C, 310C). Id. Petitioner relies on the
`following annotated Figure 28A:
`
`Petitioner’s annotated partial Figure 28A (Pet. 26).
`
`
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`20
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`As depicted above, Petitioner contends that any surface below the red
`dashed line is an inner wall. More specifically, “links 404, 406 of the
`opening element engage the inner walls (inner wall engagement highlighted
`in green) of the first and second clip arms (308C, 310C).” Pet. 25.
`Petitioner also relies on an alternative theory. See Pet. 26; Pet. Reply
`11. Petitioner contends “the opening element engages the inner bearing wall
`of pin holes in the clip arms (308C, 310C) (i.e., inner walls of the clip arms)
`via pins, which connect links 404, 406 to the clip arms (308C, 310C).” Pet.
`Reply 26. Petitioner further explains in reply that “Malecki’s links engage
`inner walls of the clip arms by engaging the inner bearing wall of the
`pinholes where the links connect to the arms via pins.” Pet. Reply 11.
`
`
`Petitioner’s annotated partial Figure 28A (Pet. Reply 11) with a half circle
`highlighted in red on the upper portion of an alleged pin hole.
`In its Reply, Petitioner modifies its theory and alleges that “Malecki’s
`
`links engage the ‘inner walls’ identified by BSSI at the edge of the walls, as
`highlighted in green [below]. (Ex.1095, ¶27).” Pet. Reply 14. Petitioner’s
`modified theory was arguably in response to Patent Owner’s claim
`construction position set forth in its Response. Petitioner argues that even
`under Patent Owner’s claim construction, which we generally adopt as noted
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`above, the claim limitation would still be met by contact along the green line
`pictured below. See Pet. Reply 12. As depicted below, Petitioner alleges
`that “links contact the ‘inner walls’ of the clip arms at the junction between
`these walls and the slots.” Id. at 14.
`
`
`Petitioner’s partial annotated Figure 28A (Pet. Reply 14) with a separate call
`out enlargement depicting a green line.
`Petitioner also argues that Malecki uses a pin channel and slot as
`further depicted below in a drawing created by Petitioner and Dr. Nicosia to
`illustrate Petitioner’s arguments:
`
`22
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`On the left is Petitioner’s partial annotated Figure 28A (Pet. Reply 15) and
`on the right is a purported cross-sectional drawing created by Dr. Nicos
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