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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
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`Petitioner,
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`v.
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`TELEFLEX INNOVATIONS S.À.R.L.,
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`Patent Owner.
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`Case IPR2020-00136
`Patent RE45,776
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`PETITIONER’S REQUEST FOR DIRECTOR REHEARING
`PURSUANT TO 37 C.F.R. § 42.71(d) AND UNITED STATES V. ARTHREX
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION ........................................................................................... 1
`I.
`LEGAL STANDARD ...................................................................................... 2
`II.
`III. BACKGROUND ............................................................................................. 2
`A.
`State of the Art ....................................................................................... 2
`B.
`Challenged Patent .................................................................................. 3
`C.
`Prior Art ................................................................................................. 4
`D.
`Procedural Background ......................................................................... 6
`IV. DIRECTOR REVIEW IS NECESSARY TO CORRECT THE
`BOARD’S ERRONEOUS SECONDARY CONSIDERATIONS
`ANALYSIS. ..................................................................................................... 7
`A.
`The Board Erred in Finding a Nexus Between the Asserted
`Secondary Considerations and the Claimed Invention. ........................ 7
`The Board Erroneously Found Evidence of Copying Patent
`Owner’s GuideLiner Product. .............................................................10
`CONCLUSION .............................................................................................. 11
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`B.
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`V.
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`i
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) ........................................................................ 8, 9
`Liqwd, Inc. v. L’Oreal USA, Inc.,
`941 F.3d 1133 (Fed. Cir. 2019) .......................................................................... 10
`Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299 (Fed. Cir. 2006) ......................... 10
`Pasteur & Universite Pierre Et Marie Curie v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) .......................................................................... 11
`Sightsound Techs., LLC v. Apple Inc., 809 F.3d 1307, 1319 (Fed. Cir.
`2015) ................................................................................................................... 10
`Other Authorities
`PTO Guidance, Arthrex Q&As | USPTO .................................................................. 2
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`ii
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`IPR2020-00136
`Patent RE45,776
`INTRODUCTION
`I.
`The Board’s Final Written Decision (“FWD,” Paper 104) upholding the
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`patentability of all challenged claims, including claims 25, 52, and 53, merits
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`Director review for two independent reasons. First, the Board erroneously found
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`that Petitioner failed to rebut the showing of nexus between the recited secondary
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`considerations and Patent Owner’s GuideLiner device. More particularly, the
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`Board erred by failing to credit Petitioner’s showing that all claim elements were
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`independently described in two separate prior art references: Itou (Ex-1407) and
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`Ressemann (Ex-1408). Because the alleged nexus results from features known in
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`the prior art, Patent Owner’s showing of secondary indicia must fail. The Board’s
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`finding cannot stand and is incongruous with fundamental tenets of patent law.
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`Second, the Board misapplied the law by finding that the evidence
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`established copying of the alleged invention. Specifically, the Board erred by
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`analyzing only whether the GuideLiner and the allegedly copied devices were
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`similar—the Board failed to perform a limitation-by-limitation analysis and this
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`was error. Importantly, the Board focused on the similarities between the products
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`as a whole, and determined that identifying such facial similarities is sufficient for
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`the copying analysis. Under the Board’s view, copying can be found simply where
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`a product is similar to the claimed invention. Had the Board done the required
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`analysis, it would have found that the claimed limitations are found in the prior art
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`1
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`IPR2020-00136
`Patent RE45,776
`(and, indeed, in most catheters). Without Director review, the Board will continue
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`to misapply the copying analysis with respect to those elements already known in
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`the prior art.
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`II. LEGAL STANDARD
`The Supreme Court has determined that final written decisions are
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`reviewable by the Director of the PTO. United States v. Arthrex, Inc., 141 S. Ct.
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`1970, 1988 (2021). The PTO clarified that the “Director’s review may address any
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`issue, including issues of fact and issues of law, and will be de novo.” PTO
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`Guidance, Arthrex Q&As | USPTO (emphases added). Accordingly, the standard of
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`review of the FWD by the Director is de novo.
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`III. BACKGROUND
`State of the Art
`A.
`Coronary artery disease occurs when plaque buildup (a “stenosis”) narrows
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`the arterial lumen that restricts blood flow and increases the risk of heart attack or
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`stroke. Petition (“Pet.,” Paper 3) at 8-9 (citing Ex-1405 ¶¶ 28-32, 34-40). Over
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`forty years ago, physicians developed percutaneous coronary interventional
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`(“PCI”) procedures that insert catheters through the femoral or radial artery to treat
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`a stenosis. Id. The basic components of catheters used during PCI have remained
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`largely unchanged during this time. Id. A physician uses a hollow needle to access
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`the patient’s vasculature, introduces a guidewire into the needle, then introduces
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`and advances a guide catheter along the vasculature until its distal end is placed in
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`2
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`IPR2020-00136
`Patent RE45,776
`the ostium of a coronary artery. Id. at 9 (citing Ex-1405, ¶¶ 34, 42-55). A guidewire
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`is threaded through the lumen of the guide catheter to the target site to advance the
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`therapeutic catheter to the occlusion. Id. The therapeutic catheter is typically
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`passed beyond the occlusion to alleviate the stenosis, which creates backward force
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`that can dislodge the guide catheter from the ostium. Id. A mother-and-child
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`catheter may mitigate this backward force where the child acts as an extension of
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`the guide catheter into the coronary artery. Id. at 9-10 (citing Ex-1405, ¶¶ 66-80).
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`B. Challenged Patent
`The ’776 patent relates “generally to catheters used in interventional
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`cardiology procedures.” Ex-1401, 1:37-38. In particular, the ’776 patent discloses
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`known features, including a guide extension catheter—referred to in the patent as a
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`“coaxial guide catheter”—that extends “beyond the distal end of the guide catheter,
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`and . . . into [a] branch artery.” Id., Abstract. The catheter assembly purports to
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`have the benefit of a mother-and-child assembly—it “assists in resisting both the
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`axial forces and the shearing forces that tend to dislodge a guide catheter from the
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`ostium of a branch artery.” Id., 5:23-27; Ex-1405, ¶¶ 118-19; Pet. at 10.
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`The patent also addresses structural characteristics of the transition at or near
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`the extension catheter’s tubular and rigid portions, sometimes referred to as a “side
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`opening” (circled in red below). Ex-1401, Figs. 4, 13-16, 7:1-17; Ex-1405, ¶ 121;
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`Pet. at 11. Claims 25, 52, and 53 of the ʼ776 patent, which are relevant to this
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`IPR2020-00136
`Patent RE45,776
`Request, all recite a partially cylindrical opening (a “side opening”). Ex-1401,
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`13:66-14:12, 16:2-5.
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`Ex. 1401, Fig. 4 (color and annotation added).
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`Prior Art
`C.
`Several types of catheters, which pre-date the ’776 patent, teach the basic
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`principles of PCI and describe the claimed technology. For example, Kontos (Ex-
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`1409)—Petitioner’s primary prior art reference in this IPR—describes “a support
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`catheter assembly with particular utility in facilitating insertion of a PTCA balloon
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`into a lesion,” Ex-1409, 1:9-13. Kontos includes support catheter 10 that serves as
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`a guide extension catheter for providing backup support, such that dislodging of
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`the guide catheter from the coronary ostium is prevented. Pet. at 17-18; Ex-1405,
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`¶¶ 136-37. Support catheter 10, as shown below, is “inserted into and passed
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`through . . . and out the distal end of the guide catheter so as to function as an
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`extension of the guide catheter to bridge the gap . . . between the end of the guide
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`catheter and the stenosis to be opened.” Pet. at 19; Ex-1409, 2:16-23.
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`Patent RE45,776
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`Pet. at 19 (citing Ex-1409, Fig. 6B).
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`Ressemann (Ex-1408) discloses an evacuation sheath assembly for treating
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`occluded vessels and reducing embolization risk during vascular interventions. Pet.
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`at 20; Ex-1408, Abstract. Ressemann includes a guide catheter, which “may be
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`positioned within the ostium of a target vessel,” (Ex-1408, 12:26-30), and an
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`evacuation sheath (i.e., a guide extension catheter) that is coaxial to and extends
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`beyond the guide catheter to treat a stenosis. Id., Abstract, 6:18-24, 12:9-14:39,
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`Figs. 6A-6F; see also Pet. at 20 (citing Ex-1405, ¶¶ 140-41). Ressemann’s sheath
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`assembly is described as facilitating delivery of stents and balloons. Ex-1408, 6:25-
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`34, 12:3-8; Pet. at 21. The evacuation assembly is described as “preferably angled”
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`(id. at 6:52-60, 24:33-38), meaning it discloses a side opening, as shown below by
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`140a:
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`Patent RE45,776
`Pet. at 27-281 (citing Ex-1408, Fig. 1A (color added)).
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`Finally, although not a specific ground for invalidity in this IPR, Itou (Ex-
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`1407) discloses a catheter assembly for alleviating the obstruction of blood flow.
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`Petitioner’s Reply (“Reply,” Paper 69) at 25-27. Itou describes a rapid-exchange
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`catheter configured to receive a wide variety of interventional cardiology devices
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`(“IVCDs”) while providing back-up support. Id. Importantly, Itou discloses the
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`side opening recited in claims 25, 52, and 53. Id.
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`Procedural Background
`D.
`The Board instituted IPR on all challenged grounds. Paper 20 at 1.
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`Petitioners asserted four separate grounds of unpatentability, all of which relied on,
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`in part, the combination of Kontos (Ex-1409) and Ressemann (Ex-1408). Pet. at 7-
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`8; Paper 20 at 7-8. Relevant here, Petitioner asserted that the Kontos-Ressemann
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`combination rendered claims 25, 52, and 53 invalid as obvious. Pet. at 21-38, 53-
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`55, 57-62. Each of these claims requires a side opening. Ex-1401, 13:66-14:12,
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`16:2-5. As set forth in the Petition, although Kontos does not include a side
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`opening, Ressemann describes this feature. Pet. at 27-30 (citing Ex-1405, ¶¶ 160-
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`174).
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`In its Final Written Decision, the Board upheld the patentability of the
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`independent claims of the ’776 patent—including claims 25, 52, and 53—based on
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`its analysis of secondary considerations of non-obviousness. FWD at 41.
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`Patent RE45,776
`Consequentially, because the independent claims were found non-obvious, so were
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`the dependent claims. Id. As to the side opening claims, the Board explained that
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`the Kontos-Ressemann combination “present[s] a close case on the question of
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`obviousness,” but that Patent Owner’s secondary indicia of non-obviousness
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`ultimately resulted in a finding of non-obviousness. FWD at 24. The Board’s
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`analysis—in particular, as to nexus and copying—is not supported by the weight of
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`the evidence and correct application of the law, meaning that the Kontos-
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`Ressemann combination renders the side opening claims invalid as obvious.
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`IV. DIRECTOR REVIEW IS NECESSARY TO CORRECT THE
`BOARD’S ERRONEOUS SECONDARY CONSIDERATIONS
`ANALYSIS.
`A. The Board Erred in Finding a Nexus Between the Asserted
`Secondary Considerations and the Claimed Invention.
`The Board erred by finding that a sufficient nexus existed despite all claim
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`elements being described in two separate prior art references: Itou (Ex-1407)1 and
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`Ressemann (Ex-1408). FWD at 40. It is bedrock law that the presumption of nexus
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`may be rebutted where, as here, the secondary indicia result from features known
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`in the prior art. In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (“Where the
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`1 Patent Owner did not swear behind Itou here as it did in related IPRs. See, e.g.,
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`IPR2020-00135. Regardless of whether Itou is prior art, claims 25, 52, and 53 are
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`invalid as obvious.
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`IPR2020-00136
`Patent RE45,776
`offered secondary consideration actually results from something other than what is
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`both claimed and novel in the claim there is no nexus to the merits of the claimed
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`invention.” (emphasis added)).
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`In determining that Patent Owner’s secondary indicia overcome “the close
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`case” of obviousness, the Board ignored that Patent Owner’s alleged evidence of
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`nexus was already described in the prior art. FWD at 40; see Reply at 25-26. In
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`particular, Itou and Ressemann are each examples of rapid exchange guide
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`extension catheters with a side opening that increases back-up support when an
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`IVCD is extended beyond the distal end of the catheter assembly. Id.
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`Importantly, Patent Owner did not dispute this showing. For example, Patent
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`Owner argued that “Itou is not prior art and was a suction catheter having a raised
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`profile pushwire not amendable to passing interventional cardiology devices.”
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`Patent Owner’s Sur-Reply (“Sur-Reply,” Paper 85) at 26. Itou, however, is prior art
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`and is configured to receive IVCDs. IPR2020-00135, Paper 1 at 24-25, Paper 22 at
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`17-18.2 What is more, the fact that Itou is a suction catheter is a non-sequitur, as
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`2 Although not an asserted ground of unpatentability in this IPR, Patent Owner did
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`not contest Itou as prior art. See generally Paper 39. As explained in related IPRs,
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`Itou discloses each element of the GuideLiner product. See IPR2020-00135, Paper
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`IPR2020-00136
`Patent RE45,776
`the relevant inquiry is whether the identified prior art discloses the recited claim
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`elements. In re Kao, 639 F.3d at 1068. Patent Owner did not dispute that Itou
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`teaches each element of claims 25, 52, and 53. Sur-Reply at 26; see also IPR2020-
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`00135, Paper 126 at 18-23. Similarly, as to Ressemann, Patent Owner argued that
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`this reference “is an embolic protection device, not a [guide extension catheter]; it
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`also discloses an offset lumen, not the coaxial lumen required by [the claims].”
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`Sur-Reply at 26. Again, the former argument is irrelevant, and the latter is just
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`incorrect. Paper 104 at 86-87. Both Itou and Ressemann individually disclose the
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`recited claim elements and for this reason, the Board erred in determining that
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`Patent Owner established a nexus to the claimed invention.
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`The record evidence does not support a nexus between Patent Owner’s
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`claims and the recited secondary considerations. In particular, the Board erred in
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`finding that “the various features of the prior art” needed to be combined. FWD at
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`40. And for this reason, the Board’s reliance on WBIP was misplaced. Id. If the
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`Board’s analysis were to stand—and indeed be replicated in future proceedings—
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`the Federal Circuit’s requirement that nexus be tied to the invention, rather than
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`elements known in the prior art, would be rendered meaningless. The Board’s
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`1. Patent Owner’s acquiescence further undercuts the Board’s conclusion that the
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`combination of known elements led to GuideLiner’s success. FWD at 40.
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`IPR2020-00136
`Patent RE45,776
`analysis is at odds with precedent demanding nexus be tied to features of the
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`claimed invention. Sightsound Techs., LLC v. Apple Inc., 809 F.3d 1307, 1319 (Fed.
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`Cir. 2015); Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1312 (Fed. Cir. 2006).
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`B.
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`The Board Erroneously Found Evidence of Copying Patent
`Owner’s GuideLiner Product.
`The Board independently erred by finding evidence that three entities—
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`Boston Scientific, QXMedical, and Medtronic—copied Patent Owner’s
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`GuideLiner Product and that this evidence is “relevant . . . and favors, at least to
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`some extent, a conclusion of non-obviousness of the claims at issue.” FWD at 38.
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`“Copying requires duplication of features of the patentee’s work. . . .”
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`Liqwd, Inc. v. L’Oreal USA, Inc., 941 F.3d 1133, 1137 (Fed. Cir. 2019) (quoting
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`Institute Pasteur & Universite Pierre Et Marie Curie v. Focarino, 738 F.3d 1337,
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`1347–48 (Fed. Cir. 2013)). The Board must analyze whether specific features of
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`the patented product were duplicated. “[M]ore is needed than merely showing that
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`similarity exists between the patent and the competitor’s accused product.” Id.
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`Here, the Board erred by only analyzing whether there were similarities between
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`the products.
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`In particular, the Board erred by analyzing the products wholesale instead of
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`performing an element-by-element analysis. Tokai Corp. v. Easton Enters., 632
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`F.3d 1358, 1371 (Fed. Cir. 2011) (focusing copying analysis on a specific claim
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`element and largely ignoring elements that “are simple mechanical parts that are
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`IPR2020-00136
`Patent RE45,776
`well known in the art”). Specifically, the Board found that the competing products
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`“when considered as a whole, are substantially similar in design to the then-
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`existing GuideLiner products on the market, including the combined use of a
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`flexible tip, reinforced portion, angled opening, pushrod, and rounded push tab.”
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`FWD at 36-37 (emphasis added).
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`But these features, as described above, were all described individually in
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`both the Itou and Ressemann references. The combined use of a flexible tip,
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`reinforced portion, angled opening, pushrod, and rounded push tab, are disclosed
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`by the prior art. See id. In other words, these combined features do not demonstrate
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`the competitors copied Petitioner’s patented product—they demonstrate the
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`competitors were replicating the prior art. The Board’s decision, if left undisturbed,
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`stands for the proposition that copying can be found simply where the product is
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`similar to the claimed invention. Such a decision that conflicts with precedent
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`holding the opposition cannot stand.
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`V. CONCLUSION
`For the reasons stated above, the Board’s FWD upholding the patentability
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`of claims 25, 52, and 53 is not supported by the weight of the evidence and correct
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`application of the law.
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`IPR2020-00136
`Patent RE45,776
`Dated: July 21, 2021
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`Respectfully submitted,
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`/Cyrus A. Morton/
`Cyrus A. Morton
`Reg. No. 44,954
`Robins Kaplan LLP
`2800 LaSalle Plaza
`800 LaSalle Avenue
`Minneapolis, MN 55402
`Attorney for Petitioner
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`12
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`IPR2020-00136
`Patent RE45,776
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`CERTIFICATE OF SERVICE
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`I certify that on July 21, 2021, a copy of Petitioner’s Request for Rehearing
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`Pursuant to 37 C.F.R. § 42.71(d) was served in its entirety by electronic mail on
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`Patent Owner’s counsel at the following addresses indicated in Patent Owner’s
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`Mandatory Notices:
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`J. Derek Vandenburgh, Reg. No. 32,179
`dvandenburgh@carlsoncaspers.com
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`Dennis C. Bremer, Reg. No. 40,528
`dbremer@carlsoncaspers.com
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`Joseph W. Winkels
`jwinkels@carlsoncaspers.com
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`Peter M. Kohlhepp
`pkohlhepp@carlsoncaspers.com
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`Tara C. Norgard
`tnorgard@carlsoncaspers.com
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`Alexander S. Rinn
`pkohlhepp@carlsoncaspers.com
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`Megan E. Christner, Reg. No. 78,979
`mchristner@carlsoncaspers.com
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`Respectfully submitted,
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`/Cyrus A. Morton/
`Cyrus A. Morton
`Reg. No. 44,954
`Attorney for Petitioner
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`Dated: July 21, 2021
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