Trials@uspto.gov
`Tel: 571-272-7822
`
`
`Paper 107
`Date: November 19, 2020
`
`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.
`_______________
`
`IPR2017-00134
`Patent 8,709,027 B2
`_______________
`
`
`Before JAMES T. MOORE, JAMES A. TARTAL, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`MOORE, Administrative Patent Judge.
`
`
`
`
`FINAL WRITTEN DECISION ON REMAND
`35 U.S.C. §§ 144, 318(a)
`
`
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`Paper 107
`Date: November 19, 2020
`
`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.
`_______________
`
`IPR2017-00134
`Patent 8,709,027 B2
`_______________
`
`
`Before JAMES T. MOORE, JAMES A. TARTAL, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`MOORE, Administrative Patent Judge.
`
`
`
`
`FINAL WRITTEN DECISION ON REMAND
`35 U.S.C. §§ 144, 318(a)
`
`
`
`
`
`
`
`
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`
`IPR2017-00134
`Patent 8,709,027 B2
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`I.
`
`Introduction
`We address this case on remand after a decision by the United States
`Court of Appeals for the Federal Circuit in Cook Group Incorporated, Cook
`Medical LLC v. Boston Scientific Scimed, Inc., 809 F. App’x 990 (Fed. Cir.
`2020) (“Cook Group I”). 1
`In our Final Written Decision of November 3, 2018, we determined
`that Cook Group Incorporated and Cook Medical LLC (“Petitioner”) had
`shown by a preponderance of the evidence that claims 1–3, 7–14, and 16–19
`of U.S. Patent No. 8,709,027 B2 (“the ’027 patent”) are unpatentable, but
`had not shown by a preponderance of the evidence that claims 4–6, 15, and
`20 of the ’027 patent are unpatentable. Paper 92, 3.
`Cook Group Incorporated and Cook Medical LLC (“Petitioner”) and
`Boston Scientific Scimed, Inc. (“Patent Owner”) each filed notices of appeal
`of our Final Written Decision. Papers 93 and 94.
`In Cook Group I, the Federal Circuit found the following:
`
`(1) affirmed our determination that Petitioner has not shown by a
`preponderance of the evidence that the ’027 patent claims 1, 3–6,
`13–15, 17, and 20 are unpatentable as anticipated under § 102 by
`Sackier2; Cook Group I, 20.
`
`(2) affirmed our determination that Petitioner has shown by a
`preponderance of the evidence that the ’027 patent claims 1–3,
`7–14, and 16–19 are unpatentable as obvious over Sackier and
`
`1 References herein are to the slip opinion, No. 19-1370 (Fed. Cir. Apr. 30,
`2020).
`2 U.S. Patent No. 5,749,881, filed on October 20, 1994, and issued May 12,
`1998 (“Sackier”) (Ex. 1008).
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`Nishioka3; id. at 20,
`
`(3) vacated our determination that Petitioner has not shown by a
`preponderance of the evidence that the ’027 patent claims 4–6, 15,
`and 20 are unpatentable as obvious over Sackier and Nishioka, and
`remanded to the Board to consider, in the first instance, the weight
`to be afforded an admission by Patent Owner in its Preliminary
`Response related to the operation of Sackier; id. at 17,
`
`(4) affirmed our determination that Petitioner has not shown by a
`preponderance of the evidence that the ’027 patent claims 1 and 3–
`11 are unpatentable as anticipated under § 102 by Malecki or as
`obvious under under § 103 over Malecki; id. at 20, and,
`
`(5) vacated our determination that Petitioner has not shown by a
`preponderance of the evidence that the ’027 patent claim 20 is
`unpatentable as anticipated under § 102 by Malecki, and remanded
`to consider whether Embodiment #2 of Malecki anticipates claim
`20 of the ’027 patent. 4 id. at 13.
`Cook Group I, passim.
`On June 30, 2020, we conducted a conference call with the parties to
`discuss post-remand procedures for this proceeding and a related proceeding
`on remand between the same parties, IPR2017-00440 (“IPR ’440”). See
`Ex. 1119 (transcript of June 30, 2020 conference call).
`
`
`3 U.S. Patent No. 5,843,000, filed on May 7, 1996, and issued on
`December 1, 1998 (“Nishioka”) (Ex. 1005).
`4 U.S. Patent No. 5,626,607, filed on February 1, 1996, and issued on May 6,
`1997 (“Malecki”) (Ex. 1003).
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`
`We authorized each party to file in this case an opening brief on
`Remand and a Responsive Brief on Remand, without new evidence.
`Petitioner submitted an opening brief setting forth the issues for us to decide
`and its arguments on those issues. Paper 104 (“Pet. Remand Br.”). Patent
`Owner also filed an opening brief. Paper 103 (“PO Remand Br.”).
`Petitioner filed a responsive brief. Paper 106 (“Pet. Remand Resp.”).
`Petitioner also filed a responsive brief. Paper 105 (“PO Remand Resp.”).
`We have jurisdiction under 35 U.S.C. § 6, and we issue this Final
`Written Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For
`the reasons discussed below, we conclude that Petitioner has established by
`a preponderance of the evidence that the ’027 patent claims 4–6, 15, and 20
`are unpatentable as obvious over Sackier and Nishioka and that Petitioner
`has not established by a preponderance of the evidence that the ’027 patent
`claim 20 is anticipated by Malecki.
`
`II. Related Matters
`This Decision on Remand is issued concurrently with a Decision on
`Remand in IPR ’440. The ’027 patent is also 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. .
`
`III. Anticipation of Claim 20 by Malecki Embodiment #2
`The ’027 Patent
`A.
`The ’027 patent is titled “Device and Method for Through the Scope
`Endoscopic Hemostatic Clipping,” and is directed towards devices and
`methods of causing hemostasis of a blood vessel through an endoscope.
`Ex. 1001, code (52). A focus of the invention is to provide medical devices
`for causing the hemostasis of blood vessels along the gastrointestinal tract.
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`Id. at 2:51–53. The basic device and method include a compression clip
`used to cause hemostasis of blood vessels and a mechanism for deploying
`the clip. Id. at 2:59–61.
`Various embodiments of the invention 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; a handle connected to the axially rigid sheath; and/or a trigger
`enclosed within the handle and engaging the control wire to close and lock
`the clip, and to uncouple the control wire from the clip. Id. at 2:63–3:5.
`Figures 10A and 10B from the ’027 patent are reproduced below.
`
`
`
`Figures 10A and 10B are cross-sectional views of
`a compressive clip in an opened and a closed position. Id. at 9:4–6.
`Claim 20
`B.
`Claim 20, a method claim of the ’027 patent, reads as follows:
`
`20. A method, comprising:
`inserting into a body a medical device comprising a clip
`having a first clip leg having a first inner surface and a
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`second clip leg having a second inner surface, a control
`member extending from a proximal actuator to the clip
`and a linkage coupled to the control member;
`positioning the medical device at a desired deployment
`location;
`moving the control member distally to cause the clip to
`move distally relative to a sleeve housing at least a
`portion of the clip therein, the movement causing the
`linkage to contact the first and second inner surfaces to
`drive the first and second clip legs radially outward to a
`tissue receiving configuration;
`adjusting a position of the clip so that target tissue is received
`between the first and second clip legs;
`drawing the control member proximally relative to the sleeve to
`draw the clip into the sleeve to receive the target tissue
`between the first and second clip legs; and
`applying a proximal tensile force of at least a threshold level to
`the control member to separate a link coupling the
`control member to the clip.
`Ex. 1001, 16:52–17:6.
`
`C. Malecki
`Malecki discloses a clamp that can be used to clamp blood vessels or
`other body parts during medical procedures. Ex. 1003, 1:18–26. Two
`Malecki embodiments are relevant. Embodiment #2 is depicted in Figure
`25, reproduced below:
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`Figure 25 is a cross sectional perspective view
`of a clamp and a clamp positioner. Id. 16:53–59.
`
`
`Figure 25 shows a clamp 304B and a clamp positioner 306B. The
`clamp 304B engages with clamp positioner 306B via engagement between
`square opening 384 on the clamp positioner and square outer surface 392 of
`jaw extension 320B. Id. at 16:53–17:6.
`In Malecki Embodiment #2, the operator turns the hollow drive
`body 346B using handle 394 while stabilizing rod 378 is prevented from
`rotating via handle 380. Id. at 17:13–33. The rotation causes jaw
`extension 320B and actuator housing 324B to engage, further causing
`actuator housing 324B to move relative to jaws 308B, 310B. See Cook
`Group I, slip op. at 4–5.
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`
`Level of Skill in the Art
`D.
`Petitioner proposes that a person of ordinary skill in the art as of the
`time of the filing of the application that became the ’027 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. 12–13 (citing Ex. 1015
`¶ 11). Patent Owner has not disputed Petitioner’s proposed level. Papers 6
`and 77, passim.
`We also consider the level of skill implied by the disclosures of the
`prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed.
`Cir. 2001) (the prior art itself can reflect the appropriate level of skill in
`the art). Additionally, this person is of ordinary creativity, not an
`automaton. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
`In view of the references, and as determined in our Final Written
`Decision, we find the Petitioner’s suggested level of skill in the art to be
`appropriate as it corresponds to the technical skill level of the art disclosures.
`Paper 92, 15. Further, the Federal Circuit implicitly considered this
`determination of the level of skill in the art and did not modify our prior
`determination on remand.
`Claim Construction
`E.
`The Board, for purposes of this decision, interprets claims in an
`unexpired patent using the “broadest reasonable construction in light of the
`specification of the patent in which [they] appear[].” 37 C.F.R. § 42.100(b)
`(2016). Under this standard, we interpret claim terms using “the broadest
`reasonable meaning of the words in their ordinary usage as they would be
`understood by one of ordinary skill in the art, taking into account whatever
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`enlightenment by way of definitions or otherwise that may be afforded by
`the written description contained in the applicant’s specification.” In re
`Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997); see In re Smith Int’l, Inc.,
`871 F.3d 1375, 1382–83 (Fed. Cir. 2017) (“[The] broadest reasonable
`interpretation . . . is an interpretation that corresponds with what and how the
`inventor describes his invention in the specification.”). “Under a broadest
`reasonable interpretation, words of the claim must be given their plain
`meaning, unless such meaning is inconsistent with the specification and
`prosecution history.” Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1062
`(Fed. Cir. 2016).
`We interpret only those terms necessary for deciding the issues
`presented in this remand. No claim terms need to be interpreted for this
`Decision.
`Analysis
`F.
`Petitioner contended that claim 20 is unpatentable, under 35 U.S.C.
`§ 102, as anticipated by Malecki Embodiment #2. Pet. 84. We address each
`claim element below. Based on the evidence of record, we determine that
`claim 20 is not anticipated by Malecki. As explained below, Malecki fails to
`disclose the claim element of “moving the control member distally” as
`required by claim 20.
`The Leahy-Smith America Invents Act (“AIA”) included revisions to
`35 U.S.C. §§ 102, 103 that became effective on March 16, 2013. Because
`the ’027 patent has an effective filing date before March 16, 2013, we apply
`the pre-AIA versions of the statutory bases for unpatentability.
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`
`Claim 20 (elements in italics):
`
`“A method, comprising:”
`Petitioner asserts that Malecki generally describes a “[c]lamp
`assembly and method of use” using any of the clamp assemblies described in
`its specification. Pet. 84 (citing Ex. 1003 [54]; and 16:51–52). We agree
`that Malecki describes a method of using a clamp assembly.
`
`“inserting into a body a medical device comprising a clip
`having a first clip leg having a first inner surface and a
`second clip leg having a second inner surface, a control
`member extending from a proximal actuator to the clip and
`a linkage coupled to the control member”
`Petitioner asserts that Malecki Embodiment #2 discloses inserting into
`a body a medical device including a clip. Pet. 84 (citing Ex. 1003, 17:28–34
`(“The clamp 304B is introduced into the thoracic cavity TC through a trocar
`sleeve 348 while in the closed position of FIG. 25.”)). Patent Owner does
`not meaningfully challenge that this limitation is disclosed in Malecki. We
`agree that Malecki describes inserting a clip into the body.
`Petitioner next asserts that the clip has first and second clip legs (first
`and second jaws 308B, 310B, respectively), each with an inner surface, and
`a control member (stabilizing rod 378 and square shaft 382) extending from
`a proximal actuator (clamp positioner 306B) to the clip (clamp 304B) as
`illustrated in Figure 25. Pet. 84–85; Ex. 1003, 16:53–17:15. With specific
`reference to Figure 25 illustrating Malecki Embodiment #2, we agree that
`Malecki describes the clip legs as claimed and the control member extending
`from the proximal actuator to the clip.
`Petitioner further asserts that Malecki’s Embodiment #2 includes a
`linkage (“torsion spring”), which is coupled to the control member
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`(stabilizing rod 378 and square shaft 382) when the actuator (clamp
`positioner 306B) is linked with the clip (clamp 304B), and which biases the
`clip legs (first and second jaws 308B, 310B, respectively) towards the open
`position. Pet. 85 (citing Ex. 1015 ¶ 122; Ex. 1003, 16:57–59 (“Jaws 308B,
`310B are normally biased towards the open position of FIG. 27B by a
`torsion spring (not shown).”)).
`According to Petitioner, the “torsion spring” relied upon as a linkage
`is shown in Figure 30B, with respect to another embodiment. Id. (citing Ex.
`1003, 18:14–15 (“A torsion spring 420 is mounted about pivot 418 which
`biases jaws 308, 310 to the open position of FIG. 30B.”)).
`We agree that the torsion spring illustrated in Malecki Figure 30
`biases the jaws open and contacts the clip legs. See Ex. 1003, Figure 30B,
`reproduced as annotated by Petitioner, reproduced below:
`
`Annotated Figure 30B is a side view in partial cross section of
`Malecki’s clamp (referred to by Petitioner as a “clip”) with yellow
`highlighting and a label identifying Figure 30B’s torsion spring 420 as
`a “linkage” and a label identifying Figure 30B’s first jaw 308E and
`second jaw 310E as “clip legs.” Pet. 85–86; Ex. 1003, 18:10–22.
`
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`
`The torsion spring (420) is a linkage coupled to the “control member”
`(stabilizing rod 378 and square shaft 382 (not shown in Figure 30B)), insofar
`as it is linked to the clip inner walls of the legs (first and second jaws 308B,
`310B, respectively), which legs are then connected to the “control member”
`shaft and rod. We therefore agree that Malecki Embodiment 2 describes
`“inserting into a body a medical device comprising a clip having a first clip
`leg having a first inner surface and a second clip leg having a second inner
`surface, a control member extending from a proximal actuator to the clip and
`a linkage coupled to the control member.”
`“positioning the medical device at a desired deployment
`location”
`Petitioner asserts that Malecki discloses positioning the medical
`device of Embodiment #2 at a desired deployment location. Pet. 86. More
`specifically, it is urged: “The clamp 304B is introduced into the thoracic
`cavity TC through a trocar sleeve 348 . . . . [until] clamp 304B is properly
`positioned . . . .” Id. (citing Ex. 1003, 17:28–39). We agree that this
`describes “positioning the medical device at the desired deployment
`location.”
`
`“moving the control member distally to cause the clip to
`move distally relative to a sleeve housing at least a portion
`of the clip therein, the movement causing the linkage to
`contact the first and second inner surfaces to drive the first
`and second clip legs radially outward to a tissue-receiving
`configuration”
`Petitioner urges that annotated Figures 25, 27A, and 27B of Malecki
`disclose moving the control member (stabilizing rod 378 and square shaft
`382) distally relative to a sleeve (actuator housing 324B) housing at least a
`portion of the clip therein (clamp 304B), the movement causing the clip
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`(clamp 304B) to move distally relative to the sleeve (actuator housing 324B)
`and the clip legs (jaws 308B, 310B) to move radially outward. Pet. 86.
`Petitioner’s Annotated Figures 25, 27A, and 27B are reproduced below:
`
`
`
`Annotated Figures 25 and 27A–B are side partial cross sectional
`views of Malecki’s clip and clamp positioner with labels identifying
`stabilizing rod 378 and square shaft 382 as a “control member”
`in Figures 25, and labels identifying clamp 304B as a “clip,”
`jaws 308B and 310B as “clip legs,” and yellow highlighting and
`a label identifying actuator housing 324B as a “sleeve” in
`Figures 27B.” Pet. 87.
`
`
`
`Petitioner observes that as the Malecki Embodiment #2 control
`member moves distally (from Figure 27A to Figure 27B), the movement
`causes the linkage (torsion spring 420, shown above in annotated Figure 30B
`of Malecki) to contact the first and second inner surfaces of the clip legs
`(jaws 308B, 310B) to drive the clip legs radially outward to a tissue-
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`receiving configuration. Pet. 87. Dr. Mark A. Nicosia, 5 Petitioner’s witness,
`so testifies. Ex. 1015 ¶ 124. The stabilizing rod 378 has a square shaft 382
`at a distal end which matingly engages a square hole 386 formed in the jaw
`extension 320B.
`This is a main point of contention between the parties. More
`specifically, the parties disagree as to the point of reference of the term
`“distally” in the limitation “moving the control member distally.” Patent
`Owner takes the position that the reference point for the term “distally” in
`claim 20 is “the user” of the clip, meaning that the control member must
`move distally from “the user.” Paper 6, 35; Paper 77, 32.
`Petitioner’s viewpoint is that claim 20 does not recite any use or
`movement of the control member relative to the user. Paper 104, 8. Instead,
`Petitioner contends the claim language “moving the control member distally
`to cause the clip to move distally relative to a sleeve” means only that the
`control member must also move distally in relation to the sleeve and the
`claim says nothing about motion in relation to the user. Paper 106, 4.
`Petitioner further urges that claim 20 refers to movement of the
`control member relative to a sleeve in multiple locations in the claim. In
`particular, after reciting the disputed claim term “moving the control
`member distally,” it is then argued that claim 20 recites the mirror image
`opposite: “drawing the control member proximally relative to the sleeve.”
`Petitioner concludes that, given that the control member is moved “relative
`
`5 Mark A. Nicosia, Ph.D. testifies via Exs. 1015, 1050, 1095, and 1100. Dr.
`Nicosia testifies to the substantive issues in this proceeding on behalf of
`Petitioner. We find him qualified to testify as to the subject matter of this
`proceeding. Ex. 1015 ¶¶ 4–7 and Exhibit B. Dr. Nicosia was deposed by
`the Patent Owner. Ex. 2011, 2039, and 2099.
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`to the sleeve” when moved proximally, the most reasonable and logical
`conclusion based on the express language of claim 20 is that the control
`member likewise moves relative to the sleeve when moved distally (the
`mirror image opposite of moving the control member proximally).
`Paper 104, 8–9.
`Patent Owner takes a different viewpoint – that “[t]his language ...
`reinforces that the patentee knew how to claim movement relative to the
`sleeve, and chose not to do so with respect to “moving the control member
`distally.” Paper 105, 4. Indeed, Patent Owner asserts that reading claim 20
`without the requirement of moving the control member distally renders the
`claim element a nullity. Paper 105, 4.
`To our view, the first term “distally” is most fairly read in the user
`context, i.e., moving distally is most appropriately interpreted as being from
`the entity that performs the claimed steps of inserting, positioning, moving,
`adjusting, drawing, and applying as found in claim 20. Id. at 16:53–17:6.
`Otherwise, the words are only excess verbiage. See, e.g., In re Sabatino,
`480 F.2d 911, 913 (CCPA 1973) (“Claim limitations defining the subject
`matter of the invention are never disregarded.”). To the extent this differs
`from our previous interpretation in the Final Written Decision, as noted
`above, this interpretation governs.
`We further observe that the ’027 patent intends for an endoscopist in
`particular to utilize the invention. Ex. 1001, 2:53–54 (“The goal of the
`invention is to give the endoscopist a technique and device which . . . 2) is
`easier to set up . . . and 3) is easier to deploy . . . .”). Thus, we find that the
`most logical context of interpreting claim 20 (to the extent there is
`vagueness about relative motion) begins with the understanding that the
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`claimed method is to be performed by a user, e.g., an endoscopist inserting
`the device into a body. Thus, the claim language “moving the control
`member distally” is in relation to that user manipulating the device inside a
`patient. And, the second part of the limitation “to cause the clip to move
`distally relative to a sleeve” is a distinct distal movement of the clip in
`relation to sleeve as claimed.
`We also find very persuasive Dr. Nicosia’s original testimony that
`“handle 380 is held stationary while the proximal end 394 of hollow drive
`body 346B is rotated thereby moving the actuator housing 324B and
`permitting jaws 308B, 310B to open.” Ex. 1015 ¶ 124, (quoting Ex. 1003,
`17:28–39). Malecki discloses that handle 380 is coupled to stabilizing rod
`378 “for preventing rotation of the stabilizing rod 378.” Id. at 17:13–15. If
`the handle 380 is held stationary as the jaws are manipulated, then the
`“control member,” which is physically connected to the handle, cannot move
`either.
`We are further convinced by Malecki’s Figures 27A and 27B,
`reproduced below. When Figures 27A and 27B are aligned (unlike
`Petitioner’s Annotated Figures above), they illustrate the relative motion of
`the actuator housing and the clip.
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`Figures 27A and 27 B are enlarged cross-sectional views of the
`proximal portion of the clamp of FIG. 25 in the closed and
`opened positions. Ex. 1003, 6:25–27.
`
`
`In the above views, it becomes apparent to us that the clamp (304B in
`Malecki’s Fig. 25 above) need not move, and the handle (380 in Malecki’s
`Fig. 25 above) and control member (jaw extension 320B in Figs. 27A and
`27B, which includes square hole 386 that matingly engages stabilizing rod
`378 with square shaft 382, shown in Fig. 25 above) need not move, but the
`actuator housing (324B) moves proximally and distally to open and close the
`clip legs (jaws 308B, 310B).
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`Therefore, we agree with Patent Owner’s assertion, backed by the
`Malecki Specification, that Malecki discloses that stabilizing rod 378 and
`square shaft 382, which Petitioner’s identify as the “control member” in
`Malecki’s Figure 25, do not move at all, let alone distally or proximally, to
`actuate the clip. Paper 88, 12–13.
`We therefore do not find Malecki Embodiment #2 to describe distal
`motion of the control member, which is held steady as the housing is turned.
`“adjusting a position of the clip so that target tissue is
`received between the first and second clip legs”
`Petitioner asserts that Malecki Embodiment #2 discloses adjusting a
`position of the clip so that target tissue is received between the first and
`second clip legs: “properly position[] [the aorta] between jaws 308, 310B.”
`Pet. 88 (citing Ex. 1003, 17:34–37). We agree that Malecki describes so
`receiving target tissue.
`
`“drawing the control member proximally relative to the
`sleeve to draw the clip into the sleeve to receive the target
`tissue between the first and second clip legs”
`Petitioner asserts that Malecki describes, via annotated Figures 25,
`27A, and 27B, shown above, the step of drawing the control member
`(stabilizing rod 378, square shaft 382) proximally relative to the sleeve
`(actuator housing 324B) to draw the clip (clamp 304B) into the sleeve to
`receive target tissue between the clip legs (jaws 308B, 310B). Pet. 89 (citing
`Ex. 1003, 17:28–39).
`We agree that as the “control member” of Malecki Embodiment #2 is
`drawn proximally relative to the sleeve, it draws the clip into the sleeve to
`perform the function of receiving the target tissue between the clip legs,
`even as it does not move relative to the user.
`
`18
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`“applying a proximal tensile force of at least a threshold
`level to the control member to separate a link coupling the
`control member to the clip”
`Petitioner finally asserts that Malecki discloses “applying a proximal
`tensile force of at least a threshold level to the control member to separate a
`link coupling the control member to the clip.” Pet. 90. More specifically, it
`is asserted that the clamp positioner 306B is preferably removed from the
`patient through trocar sleeve 348, while the clip (clamp 304B) remains
`behind in the body. Id. (citing Ex. 1015 ¶ 127; Ex. 1003, 17:35–39, 18:34–
`37). We agree that Malecki Embodiment #2 thus describes that the clip is
`separable from the clamp positioner after being clamped onto a hollow body
`structure. Ex. 1003, 18:34–37.
`Considering the totality of the record before us, including instruction
`by our reviewing court, we determine that Petitioner has not shown by a
`preponderance of the evidence that Malecki Embodiment #2 anticipates
`claim 20 of the ’027 patent. As examined in detail above, this embodiment
`of Malecki fails to disclose the distal movement of the control member
`limitation.
`
`IV. The Obviousness of Claims 4–6, 15, and 20 over Sackier and
`Nishioka
`Petitioner contends that claims 1–20 were unpatentable under 35
`U.S.C. § 103(a) as obvious over Sackier and Nishioka. Pet. 44–69. We
`previously found claim 1 unpatentable under 35 U.S.C. § 103(a) as obvious
`over Sackier and Nishioka. Paper 92, 41. That finding was affirmed by the
`court in Cook Group I, at 20.
`
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`Claims 1 and 4
`A.
`Claim 1 recites as follows:
`
`1. A medical device, comprising:
`a clip having a first clip leg having a first inner surface and
`a second clip leg having a second inner surface;
`a control member extending from a proximal actuator to
`the clip; and
`a linkage operably associated with the control member to
`spread the first and second clip legs apart from one
`another into a tissue-receiving configuration as the control
`member is moved distally relative to the clip, the
`linkage contacting the inner surfaces of the first and
`second clip legs to drive the first and second clip legs
`radially outward as the control member is moved distally
`relative to the clip.
`
`
`Ex. 1001, 15:33–45.
`
`
`
`
`
`Claim 4 depends from claim 1 and recites as follows:
`
`4. The medical device of claim 1, further comprising a
`
`frangible link coupling the clip to the control member.
`
`The Cited Art
`B.
`Sackier, U.S. Patent No. 5,749,881 (“Sackier”), issued on May 12,
`1998, for a “Laparoscopic Surgical Clamp.” Ex. 1008. Sackier discloses a
`clamp that can be moved between a free (open) state and operable (closed)
`state for use in occluding portions of the body during laparoscopic surgery.
`The device is designed to fit within the trocar used to per-form the surgery.
`Sackier also discloses a clamp applier that contains a means to engage and
`disengage the clamp jaws. Cook Group I, slip op. at 5–6. The relevant
`aspects of Sackier are depicted in Figures 15–17 below:
`
`
`20
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`Figures 15–17 are Petitioner’s Annotated
`cross sectional views of a clamp and clamp applier. 6
`
`
`Nishioka, issued on December 1, 1998 for “Optical Biopsy Forceps
`and Method of Diagnosing Tissue.” Ex. 1005. Nishioka discloses an
`integrated optical biopsy forceps device. The device includes a pair of
`cutting jaws that are drawn together via control links. Cook Group I, slip op.
`at 6.
`
`
`6 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. 17–
`18, n.5.
`
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`Figure 8 of Nishioka is reproduced below:
`
`\
`
`Figure 8 is a cross-sectional view of a biopsy forceps.
`Ex. 1005, 3:34–36.
`
`As shown in Figure 8 above, forceps 100 include cutting jaws 180,
`181. Ex. 1005, 6:60–62. The cutting jaws are hingedly connected to support
`block 122. Id. at 7:65–66. Control links 136 and 138 operate to open and
`close the jaws when an optical fiber is displaced. Id. at 8:8–43.
`Our prior Final Written Decision finding that Petitioner had shown by
`a preponderance of evidence that claims 1–3, 7–14, and 16–19 are
`unpatentable as obvious over Sackier and Nishioka was affirmed by our
`reviewing court. Paper 92, 67, Cook Group I, 20. We therefore are limited
`in this remand to the court’s instruction to consider specific issues
`concerning only claims 4–6, 15, and 20.
`C. Claim Construction
`We interpret only those terms necessary for deciding the issues
`presented in this remand.
`
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`Frangible link
`Petitioner asserts that the term “frangible link” means a “link between
`at least two components that become unlinked when a tensile load is
`applied.” Pet. 14–15. Again, this interpretation is proposed in part because
`Patent Owner asserted it in the related district court proceeding. Ex. 1004,
`13. Patent Owner does not dispute this interpretation. PO Resp. 25. We
`agree this is an appropriate interpretation, principally because frangible in
`the Specification includes “pulled from” and “frangible” generally means
`“breakable.” Ex. 1001, 5:44–58.
`
`D.
`
`Analysis
`Claim 4
`Claim 4 depends from claim 1 and further states that there is “a
`frangible link coupling the clip to the control member.” Ex. 1001, 15:53–54.
`Petitioner asserts that Sackier’s ball 163 and flange 176 form a link coupling
`the clip to the control member, the link being frangible in that it becomes
`unlinked when a tensile load is applied. Pet. 54 (citing Ex. 1008, 10:18–30,
`2:56–59).
`It should be noted that claims 1 and 4 do not have a limitation that the
`frangibility occur within the body.
`Sackier Annotated Figures 15–16, reproduced below, illustrate the
`ball and flange.
`
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`Figures 15–17 are Petitioner’s Annotated
`cross sectional views of a clamp and clamp applier.
`
`
`Patent Owner is of the position, based upon Dr. Vaitekunas’
`testimony, that the link between the flange 176 and the ball 163 is not a
`frangible link because it does not unlink when a tensile load is applied.
`Ex. 2031 ¶ 95. Applying a tensile force or pulling the clamp applier will not
`unlink flange 176 and ball 163, so that the jaws are no longer coupled to the
`control member. PO Resp. 49–50. This theory is impacted by Patent
`Owner’s Preliminary Response (Paper 6) as further discussed below.
`Patent Owner asserts that the Sackier’s Specification states that
`annular flange 176 has an inside diameter greater
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