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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 IPR2020-00130
`Patent RE45,380
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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. ............................................................... 9
`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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`IPR2020-00130
`Patent RE45,380
`INTRODUCTION
`I.
`The Board’s Final Written Decision (“FWD,” Paper 103) upholding the
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`patentability of claims 3, 4, 9, 14, and 19 merits Director review for two
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`independent reasons. First, the Board erroneously found that Petitioner failed to
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`rebut the showing of nexus between the recited secondary considerations and
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`Patent Owner’s GuideLiner device. More particularly, the Board erred by failing to
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`credit Petitioner’s showing that all claim elements were independently described in
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`two separate prior art references: Itou (Ex-1407) and Ressemann (Ex-1408).
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`Because the alleged nexus results from features known in the prior art, Patent
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`Owner’s showing of secondary indicia must fail. The Board’s finding cannot stand
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`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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`IPR2020-00130
`Patent RE45,380
`(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 1) at 8 (citing Ex-1405 ¶¶ 28-32, 34-40). Over forty
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`years ago, physicians developed percutaneous coronary interventional (“PCI”)
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`procedures that insert catheters through the femoral or radial artery to treat a
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`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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`IPR2020-00130
`Patent RE45,380
`the ostium of a coronary artery. Id. at 8 (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. (citing Ex-1405, ¶¶ 66-80).
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`B. Challenged Patent
`The ’380 patent relates “generally to catheters used in interventional
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`cardiology procedures.” Ex-1401, 1:31-32. In particular, the ’380 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., 5:16-20; Ex-1405, ¶¶ 118-19; Pet. at 9.
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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, 6:62-7:11; Ex-1405,
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`¶ 121; Pet. at 10-11. Claims 3, 4, 9, 14, and 19 of the ʼ380 patent, which are
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`3
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`IPR2020-00130
`Patent RE45,380
`relevant to this Request, all recite a side opening or describe various characteristics
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`of a side opening. Ex-1401, 11:54-57, 13:14-17.
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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 ’380 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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`¶¶ 140-41. 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 18-19; Ex-1409, 2:16-23.
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`4
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`IPR2020-00130
`Patent RE45,380
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`Pet. at 19 (citing Ex-1409, Fig. 6B).
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`Adams (Ex-1435) describes a catheter assembly with (i) a guide catheter, (ii)
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`a sealing device (i.e., guide extension catheter) sized to fit within the lumen of, and
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`advance distal to, the guide catheter, and (iii) a protection device that is advanced
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`distal to both the guide catheter/sealing device assembly and the occlusion to be
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`treated. Pet. at 21; Ex-1435, [0045], [0064]. Adams includes a proximal side
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`opening, teaching a guide seal 30 with proximal end 31 that is “preferably cut or
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`formed at an angle.” Pet. at 47; Ex-1435, [0066].
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`Ex-1435, Fig. 3A.
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`Finally, although neither is a specific ground for invalidity in this IPR, Itou
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`(Ex-1407) and Ressemann (Ex-1408) each disclose a catheter assembly for
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`5
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`IPR2020-00130
`Patent RE45,380
`alleviating the obstruction of blood flow. Petitioner’s Reply (“Reply,” Paper 69) at
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`22-24. Both references describe a rapid-exchange catheter configured to receive a
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`wide variety of interventional cardiology devices (“IVCDs”) while providing back-
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`up support. Id. Importantly, both Itou and Ressemann disclose the side opening
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`recited in claims 3, 4, 9, 14, and 19. Id.
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`Procedural Background
`D.
`The Board instituted IPR on all challenged grounds. Paper 20 at 1-2.
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`Petitioners asserted three separate grounds of unpatentability, all of which relied
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`on, in part, the combination of Kontos (Ex-1409) and Adams (Ex-1435). Pet. at
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`6-7; Paper 20 at 7-8. Relevant here, Petitioner asserted that the Kontos-Adams
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`combination rendered claims 3, 4, 9, 14, and 19 invalid as obvious. Pet. at 46-53,
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`55-57, 7-68, 70. Each of these claims recites a “side opening,” or otherwise
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`describes elements defining a side opening. Ex-1401, 11:54-57, 13:14-17. As set
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`forth in the Petition, although Kontos does not include a side opening, Adams
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`describes this feature. Pet. at 47 (citing Ex. 1435, [0066], Fig. 3A).
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`In its Final Written Decision, the Board found claims 1, 2, 6, 7, 12, 13, 15-
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`17, 20, and 21 invalid as obvious. FWD at 80-81. As to the side opening claims,
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`the Board explained that the Kontos-Adams combination “present[s] a close case
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`on the question of obviousness,” but that Patent Owner’s secondary indicia of non-
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`obviousness ultimately resulted in a finding of non-obviousness. FWD at 37-38.
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`6
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`IPR2020-00130
`Patent RE45,380
`The Board’s analysis—in particular, as to nexus and copying—is not supported by
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`the weight of the evidence and correct application of the law, meaning that the
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`Kontos-Adams 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 53. 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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`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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`1 Patent Owner did not swear behind Itou here as it did in related IPRs. See, e.g.,
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`IPR2020-00128. Regardless of whether Itou is prior art, claims 3, 4, 9, 14, and 19
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`are invalid as obvious.
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`7
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`IPR2020-00130
`Patent RE45,380
`nexus was already described in the prior art. FWD at 53-54; see Reply at 22-24. 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 84) at 25. Itou, however, is prior art
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`and is configured to receive IVCDs. IPR2020-00128, Paper 1 at 45-46, Paper 22 at
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`18.2 What is more, the fact that Itou is a suction catheter is a non-sequitur, as the
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`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 3, 4, 9, 14, and 19. Sur-Reply at 25; see also
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`IPR2020-00128, Paper 127 at 17-22. Similarly, as to Ressemann, Patent Owner
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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 41. As explained in related IPRs,
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`Itou discloses each element of the GuideLiner product. See IPR2020-00128, Paper
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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 38-39.
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`8
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`IPR2020-00130
`Patent RE45,380
`argued that this reference “is an embolic protection device, not a [guide extension
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`catheter]]; it also discloses an offset lumen, not the coaxial lumen required by [the
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`claims].” Sur-Reply at 25. Again, the former argument is irrelevant, and the latter is
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`just incorrect. Paper 104 at 86-87. Both Itou and Ressemann individually disclose
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`the 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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`52-53. 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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`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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`9
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`IPR2020-00130
`Patent RE45,380
`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 51.
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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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`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 49-50 (emphasis added).
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`10
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`IPR2020-00130
`Patent RE45,380
`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 3, 4, 9, 14, and 19 is not supported by the weight of the evidence and
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`correct application of the law.
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`Dated: July 21, 2021
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`Respectfully submitted,
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`
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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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`11
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`IPR2020-00130
`Patent RE45,380
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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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`12
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`Dated: July 21, 2021
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