IPR No. 2017-00134
`Patent No. 8,709,027
`
`By: David A. Caine (Reg. No. 52,683)
` Arnold & Porter Kaye Scholer LLP
` 3000 El Camino Real
` Five Palo Alto Square, Suite 500
` Palo Alto, California 94306-3807
` Telephone: 650.319.4500
` Facsimile: 650.319.4700
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`Cook Group Incorporated and Cook Medical LLC,
`
`Petitioners,
`v.
`Boston Scientific Scimed, Incorporated,
`
`Patent Owner.
`________________
`Case IPR2017-00134
`Patent No. 8,709,027
`________________
`
`PATENT OWNER’S BRIEF ON REMAND
`
`
`Patent No. 8,709,027
`
`By: David A. Caine (Reg. No. 52,683)
` Arnold & Porter Kaye Scholer LLP
` 3000 El Camino Real
` Five Palo Alto Square, Suite 500
` Palo Alto, California 94306-3807
` Telephone: 650.319.4500
` Facsimile: 650.319.4700
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`Cook Group Incorporated and Cook Medical LLC,
`
`Petitioners,
`v.
`Boston Scientific Scimed, Incorporated,
`
`Patent Owner.
`________________
`Case IPR2017-00134
`Patent No. 8,709,027
`________________
`
`PATENT OWNER’S BRIEF ON REMAND
`
`
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`
`TABLE OF CONTENTS
`
`Page
`INTRODUCTION ........................................................................................... 1
`
`ARGUMENT ................................................................................................... 1
`
`I.
`
`II.
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`
`Page(s)
`
`Cases
`
`Aktiebolaget Karlstads Mekaniska Werkstad v. U.S. Int’l Trade
`Comm’n, 705 F.2d 1565 (Fed. Cir. 1983) ............................................................ 2
`
`Cook Grp. Inc. v. Boston Scientific Scimed, Inc.,
`809 Fed. App’x 990 (Fed. Cir. 2020) ................................................................... 9
`
`Dell Inc. v. Acceleron, LLC,
`818 F.3d 1293 (Fed. Cir. 2016) ............................................................................ 8
`
`In re Man Mach. Interface Techs. LLC,
`822 F.3d 1282 (Fed. Cir. 2016) ............................................................................ 8
`
`Leapfrog Prod. Development, LLC v. LifeFactory, Inc.,
`IPR2015-00614, Paper 31, 27-28 (PTAB Aug. 17, 2016) ................................... 2
`
`ii
`
`
`
`EXHIBITS
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`
`Description
`
`Exhibit No.
`2001-2006 Intentionally Skipped
`2007
`U.S. Patent No. 8,852,211 B2 (issued Oct. 7, 2014)
`Mark A. Nicosia et al., Mechanical response of uterine tissue under the
`influence of hemostatic clips: A non-linear finite-element approach, 6
`J. Biomedical Science and Engineering 21 (2013)
`2009
`The Merriam-Webster Dictionary 183 (1997)
`2010
`Intentionally Skipped
`2011
`Deposition of Mark A. Nicosia, Ph. D., August 3, 2017
`2012-2028
`Intentionally Skipped
`Declaration of Dr. Jeffrey Vaitekunas in Support of Patent Owner’s
`2029
`Response in IPR2017-00135
`2030
`Intentionally Skipped
`Declaration of Dr. Jeffrey Vaitekunas in Support of Patent Owner’s
`2031
`Response in IPR2017-00134
`2032-2037 Intentionally Skipped
`Errata Sheet for the November 15, 2017 Deposition of Dr. Jeffery
`2038
`Vaitekunas, Ph.D.
`2039
`Deposition Transcript of Mark A. Nicosia, Ph. D., January 17, 2018
`Declaration of Dr. Jeffrey Vaitekunas in Support of Patent Owner’s
`2040
`Response Regarding Claim 20 in IPR2017-00134
`2041-2098
`Intentionally Skipped
`2099
`Deposition Transcript of Mark A. Nicosia, Ph. D., March 5, 2018
`Eleonora P. Westebring-van der Putten et al., Effect of laparoscopic
`2100
`grasper force transmission ratio on grasp control (2009)
`Declaration of Dr. Jeffrey Vaitekunas in Support of Patent Owner’s
`Supplemental Response
`
`2008
`
`2101
`
`iii
`
`
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`
`I.
`
`INTRODUCTION
`The two issues presented to the Board on remand are: (1) whether ’027
`
`patent Claims 4-6, 15, and 20 are obvious over Sackier in view of Nishioka,
`
`including consideration of the weight that should be accorded to Patent Owner’s
`
`preliminary responses in the related IPR2017-00134 and -00135 proceedings; and
`
`(2) whether ’027 patent Claim 20 is anticipated by Malecki Embodiment #2. With
`
`respect to the first question, the Federal Circuit held that the Board may assign zero
`
`weight to the preliminary responses. This is what the Board should do. The
`
`portions of the preliminary response upon which Petitioners rely, when read in
`
`context of the description of Sackier as a whole and further in view of the Patent
`
`Owner response and other contemporaneous arguments about Sackier, do not
`
`support Petitioners’ theory. With respect to the second question, the Board’s
`
`findings with respect to Malecki Embodiment #1’s stabilizing rod 378 and square
`
`shaft 382 apply equally to Malecki Embodiment #2. These findings compel a
`
`determination of no anticipation based on the plain language of Claim 20.
`
`II.
`
`ARGUMENT
`
`-1-
`
`
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`The Federal Circuit and other courts have instructed that, when resolving a
`
`dispute over the scope of an admission, it is important not to “take an arguably
`
`ambiguous statement and construe it in the manner most detrimental to [the party],
`
`regardless of its explanations and attempted clarifications.” Aktiebolaget Karlstads
`
`Mekaniska Werkstad v. U.S. Int'l Trade Comm'n, 705 F.2d 1565, 1574 (Fed. Cir.
`
`1983); Leapfrog Prod. Development, LLC v. LifeFactory, Inc., IPR2015-00614,
`
`Paper 31, 27-28 (PTAB Aug. 17, 2016) (alleged “admission” unpersuasive where
`
`it was “quoted out of context in a manner that mischaracterizes its meaning”).
`
`Here, Patent Owner’s preliminary responses in IPR2017-00134 and -00135
`
`argued that Sackier’s “clamp applier in Figure 16” is “widened” to attach the
`
`clamp” and that “the cylinders are moved outwardly.” (Paper 6, 17-18; IPR2017-
`
`00135, Paper 6, 33-34). Petitioners contend that these statements demonstrate that
`
`Sackier’s cylinder 174 and flange 176 can be pulled away from the ball 163 by
`
`radially expanding the cylinder to accommodate the ball, which allegedly supports
`
`Petitioners’ theory that Sackier’s laparoscopic clamp is capable of being
`
`disengaged axially. The statements upon which Petitioners rely are taken out of
`
`context and, when so read, ambiguous. The argument neither describes any radial
`
`expansion of cylinders 170 and 174, nor adopts Petitioners’ theory that “axial”
`
`force can be used to engage Sackier’s clamp or that a proximal tensile force can be
`
`used to disengage Sackier’s clamp. Patent Owner never made such arguments.
`
`-2-
`
`
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`Moreover, the ambiguity in the particular isolated statements upon which
`
`Petitioners rely is resolved by subsequent descriptions of Sackier in the preliminary
`
`responses. Patent Owner expressly argued in its -00134 and -00135 preliminary
`
`responses: “Contrary to Petitioner’s assertions, Sackier does not disclose that
`
`applying proximal tensile force to the inner shaft 58a will separate the connection
`
`between the ball 163 and flange 176.” (Paper 6, 18; IPR2017-00135, Paper 6, 35).
`
`The Board agreed, finding this argument, and the evidence that supports it,
`
`persuasive. (IPR2017-00135, Paper 82, 45-46 (“Patent Owner argues persuasively
`
`that applying proximal tensile force to outer tube 23a would move slide 47a
`
`proximally before any potential disengagement, thus, proximal tensile forces could
`
`not be applied sequentially to inner shaft 58a and tube 23a to separate the second
`
`connection between flange 172 and flange 167.”)). As Patent Owner repeatedly
`
`argued, Petitioners’ axial engagement/disengagement theory would render the
`
`device inoperable because clamp jaws 36a and 38a would open through proximal
`
`movement of slide 47a relative to jaws 36a and 38a before the annular flange 167
`
`would purportedly be pulled through the distal end (flange 172) of cylinder 170.
`
`And, as the Board correctly determined, this would lead to the very undesirable
`
`separation that Sackier sought to avoid. (Paper 92, 47 (citing EX1008, 1:54-57)).
`
`In determining whether to give any weight to Patent Owner’s preliminary
`
`responses in IPR2017-00134 and -00135, it is also important to consider Patent
`
`-3-
`
`
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`Owner’s contemporaneous arguments about Sackier. In its preliminary response in
`
`IPR2017-00131, Patent Owner argued that Sackier discloses that axial forces open
`
`and close the clamp, not release the clamp. See IPR2017-00131, Paper 12, 14-17
`
`(“Sackier never discloses any way to move the clamp to a released configuration
`
`once it is in the configuration provided in FIG. 17, and in particular, never
`
`describes or anticipates any use whereby both detent features [flange 172/recess
`
`165 and flange 176/recess 161] could be disengaged, which would be necessary
`
`to decouple the clamp (e.g., FIG. 15) from the clamp applier (e.g., FIG. 16).”)
`
`(emphasis added), 19-21 (explaining that “axial movement . . . causes jaws 36a and
`
`38a of clamp 10a to open and close” and “[c]ritically, Sackier does not disclose the
`
`release of clamp 10a.”). Thus, throughout its preliminary response arguments in
`
`IPR2017-00131, Patent Owner consistently argued that the clamp of the
`
`embodiment of Sackier’s Figures 15-17 could not be disengaged axially from the
`
`clamp applier through application of a proximal tensile force or by fracturing a
`
`“frangible link.”
`
`Indeed, Petitioners’ argument and inaccurate characterizations of the
`
`preliminary responses are inconsistent with the patent owner responses in -00134
`
`and related proceedings in which Patent Owner argued, based on Dr. Vaitekunas’
`
`explanations, that Sackier discloses openings in each of cylinders 170 and 174 to
`
`permit lateral engagement of annular flange 167 and ball 163.
`
`-4-
`
`
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`Finally, the Board found that Petitioners failed to carry their burden due to
`
`the clear, consistent, and persuasive testimony of Patent Owner’s expert, Dr.
`
`Vaitekunas. (IPR2017-00135, Paper 82, 45, 47-48). Nothing in the -00134 and -
`
`00135 preliminary responses undermine Dr. Vaitekunas’ credibility. Thus, the
`
`Board should give no weight to the preliminary responses.
`
`2.
`
`The Arguments and Evidence of Record Demonstrate that
`Sackier Does Not Disclose a “Frangible Link”
`The Federal Circuit directed the Board not to incorporate by reference its
`
`decision in IPR2017-00135. Thus, to assist the Board in its review of the present
`
`record, Patent Owner provides an outline of Patent Owner’s arguments and
`
`evidence in these proceedings.
`
`First, Sackier’s design objective was to avoid undesirable separation of the
`
`clamp from the applier. (Paper 77, 22; EX2101 ¶ 70; Paper 52, 61:17-23). Thus, a
`
`POSITA would have understood that the dimensions of the respective cylinders
`
`and flanges would have prevented separation upon application of a proximal
`
`tensile force. (Paper 77, 22-23; EX2101 ¶ 70).
`
`Second, Sackier teaches only that the clamp depicted in Figures 1-10, which
`
`includes a hook and annulus engagement that allows the clamp to open and close
`
`by rotating an axial screw, can be disengaged. (Paper 77, 23-24; EX2101 ¶¶ 39-
`
`48, 71; Paper 52, 62:1-16; EX1008, 2:12-21, 5:66-6:3, 6:58-7:17, 7:19-21, 8:31-
`
`33). A POSITA would have understood those portions of Sackier do not apply to
`
`-5-
`
`
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`the structurally distinct embodiment depicted in Figures 15-17, upon which
`
`Petitioners rely. (Paper 77, 24, 30-31 n.2; EX2101 ¶ 80).
`
`Third, a POSITA would have understood that Sackier discloses openings in
`
`the cylinders 170 and 174 at the distal end of outer tube 23a and inner shaft 58a.
`
`(Paper 77, 25; EX2101 ¶¶ 73-74).
`
`Fourth, a POSITA would have understood that an axial snap-fit mechanism
`
`under Petitioners’ theory would have required a material that was too flexible to
`
`also support the clamping of Sackier’s jaws. (Paper 77, 26; EX2101 ¶ 75; Paper
`
`91, 69:9-20).
`
`Fifth, a POSITA would have understood that a physician using Sackier’s
`
`clamp within the body could not apply the axially opposing forces necessary to
`
`disengage the flanges and their respective recesses without risking significant
`
`damage to the body conduit being clamped. (Paper 77, 26-27; EX2101 ¶¶ 76-84;
`
`Paper 52, 62:17-65:5; Paper 72, 84:16-85:10; Paper 91, 70:5-13, 77:3-78:4).
`
`Sixth, a POSITA would have understood that applying a proximal tensile
`
`force to separate Sackier’s clamp from the clamp applier would render Sackier’s
`
`clamp useless for its express purpose—i.e., clamping a body conduit such as a
`
`bowel—because the clamp jaws would open before slide 47a could be disengaged
`
`from outer tube 23a. (Paper 77, 28-31; EX2101 ¶¶ 85-86; Paper 52, 62:17-65:5,
`
`72:11-15; Paper 72, 85:11-14; Paper 91, 69:21-70:4, 70:14-71:13).
`
`-6-
`
`
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`
`-7-
`
`
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`for example, moving the sleeve proximally while holding the control member
`
`stationary. Petitioners would thus improperly broaden the claim by eliminating the
`
`requirement that the control member itself move distally. Dell Inc. v. Acceleron,
`
`LLC, 818 F.3d 1293, 1299-300 (Fed. Cir. 2016) (reversing construction that failed
`
`to give effect to all language of the claim); In re Man Mach. Interface Techs. LLC,
`
`822 F.3d 1282, 1286-87 (Fed. Cir. 2016) (reversing construction that read out
`
`claim term “thumb”).
`
`Petitioners’ construction is also wrong because the claim requires the “clip”
`
`to “move distally relative to a sleeve housing at least a portion of the clip therein.”
`
`It does not require relative motion between the control member and the sleeve.
`
`(Paper 79, 33). The Board should thus adopt Patent Owner’s construction, which
`
`gives effect to all claim terms, including the requirement that the control member
`
`move distally.
`
`2. Malecki Embodiment #2’s Stabilizing Rod 378 Is Not a
`Control Member and Does Not Move Distally
`The “control member” of Claim 20 must control actuation of the clip.
`
`(EX1001, 5:46-49). The stabilizing rod 378 and square shaft 382 of Malecki
`
`Embodiment #2, however, do not actuate Malecki’s clamp jaws. The stabilizing
`
`rod 378 is held stationary and prevents the clamp assembly from rotating 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.” (EX1003,
`
`-8-
`
`
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`16:60-65, 17:30-33). Rotation of the proximal end of hollow drive body 346B in
`
`the opposite direction closes the jaws 308B, 310B, not the stabilizing rod 378 or
`
`square shaft 382. (Id., 17:34-36). Stabilizing rod 378 and square shaft 382 are
`
`thus not a “control member.”
`
`Furthermore, the Board already determined that stabilizing rod 378 does not
`
`move distally. (Paper 92, 65 (“Finally, Patent Owner contends, and we agree, that
`
`even if stabilizing rod 378 constituted the ‘control member,’ Petitioner has not
`
`established persuasively that the stabilizing rod is moved distally relative to the
`
`clamp.”); id. (citing EX1003 at 17:7-10 and concluding that this portion of Malecki
`
`“does not describe any distal movement of stabilizing rod 378, but rather ‘rotation
`
`of the actuator housing 324B,’ which ‘moves the actuator housing 324B relative to
`
`the jaws 308B, 310B’”)). Indeed, Malecki discloses 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.” (EX1003, 17:28-39 (emphasis added); Paper 88, 12-13). The Federal
`
`Circuit agreed, finding that, “[i]n Malecki Embodiment #2, the operator turns the
`
`hollow drive body 346B using handle 394 while the stabilizing rod 378 is
`
`prevented from rotating via handle 380.” Cook Grp. Inc. v. Boston Scientific
`
`Scimed, Inc., 809 Fed. App’x 990, 993 (Fed. Cir. 2020); see also EX1003, 17:13-
`
`15; id., 16:61-65 (“The hollow drive body 346B actuates the jaws while the
`
`-9-
`
`
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`stabilizing rod 378 stabilizes the clamp assembly against the torsional forces
`
`produced by rotational actuation of the rotatable drive body 346B.”)). Therefore,
`
`because stabilizing rod 378 and square shaft 382 do not move (Paper 88, 12-13),
`
`Malecki Embodiment #2 does not anticipate Claim 20.
`
`III. CONCLUSION
`For all of these reasons, Patent Owner respectfully requests that the Board
`
`find that Claims 4-6, 15, and 20 of the ’027 patent are not unpatentable.
`
`Dated: August 3, 2020
`
`Respectfully submitted,
`
`/s/ David A. Caine
`David A. Caine (Reg. No. 52,683)
`Arnold & Porter Kaye Scholer LLP
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, California 94306-3807
`Telephone: 650.319.4500
`Facsimile: 650.319.4700
`
`Wallace Wu (Reg. No. 45,380)
`Arnold & Porter Kaye Scholer LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel: (213) 243-4000
`Fax: (213) 243-4199
`
`Attorneys for Patent Owner Boston
`Scientific Scimed, Inc.
`
`-10-
`
`
`
`CERTIFICATE OF COMPLIANCE
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`
`The undersigned certifies that this Patent Owner’s Brief on Remand
`
`complies with the type-volume limitations of 37 C.F.R. § 42.24(a)(1)(i). Per the
`
`Board’s Order (Paper 101), this brief is no more than 10 pages long.
`
`The undersigned further certifies that this brief complies with the typeface
`
`requirements of 37 C.F.R. § 42.6(a)(2)(ii) and typestyle requirements of 37 C.F.R.
`
`§ 42.6(a)(2)(iii). This brief has been prepared in a proportionally spaced typeface
`
`using Microsoft Word 2010 in Times New Roman 14 point font.
`
`Dated: August 3, 2020
`
`Respectfully submitted,
`
`/s/ David A. Caine
`David A. Caine (Reg. No. 52,683)
`Arnold & Porter Kaye Scholer LLP
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, California 94306-3807
`Telephone: 650.319.4500
`Facsimile: 650.319.4700
`
`-11-
`
`
`
`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing Patent Owner’s Brief
`
`on Remand was served on August 3, 2020 to the following Counsel for Petitioner
`
`IPR No. 2017-00134
`Patent No. 8,709,027
`
`via e-mail:
`
`Jeffry M. Nichols (Reg. No. 46,958)
`jnichols@brinksgilson.com
`Robert Mallin (Reg. No. 35,596)
`rmallin@brinksgilson.com
`Jason W. Schigelone (Reg. No. 56,243)
`jschigelone@brinksgilson.com
`James M. Oehler (Reg. No. 68,591)
`joehler@brinksgilson.com
`Andrew S. McElligott
`amcelligott@brinksgilson.com
`BRINKS GILSON & LIONE
`NBC Tower, Suite 3600
`455 N. Cityfront Plaza Dr.
`Chicago, Illinois 60611-5599
`Tel: (312) 321-4200
`Fax: (312) 321-4299
`
`Attorneys for Petitioners Cook Group Incorporated and Cook Medical LLC
`
`/s/ David A. Caine
`David A. Caine (Reg. No. 52,683)
`Arnold & Porter Kaye Scholer LLP
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, California 94306-3807
`Telephone: 650.319.4500
`Facsimile: 650.319.4700
`
`i
`
`
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