`Teleflex Innovations S.A.R.L.
`
`Patent Owner’s
`Hearing Demonstratives
`on CRTP
`
`Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A.
`Attorney-Client Privileged & Work Product
`
`1
`
`
`
`Petitioner Bears the Burden of Persuasion on CRTP
`
`In an inter partes review, 35 U.S.C. § 316(e) imposes the ultimate burden of
`persuasion to “prove unpatentability by a preponderance of the evidence” onto
`the petitioner. This burden never shifts to the patent owner. Dynamic
`Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
`However, when the patent owner attempts to antedate the prior art, “[a] second
`and distinct burden, the burden of production” can shift between the petitioner
`and the patentee. Id. at 1379; see In re Magnum Oil Tools Int’l, Ltd., 829 F.3d
`1364, 1375–76 (Fed. Cir. 2016). Specifically, the patent owner “bears the
`burden of establishing that its claimed invention is entitled to an earlier priority
`date than an asserted prior art reference.” Magnum Oil Tools, 829 F.3d at
`1375–76. Once the patent owner establishes it is entitled to an earlier priority
`date, the burden of production then shifts back to the petitioner “to convince the
`court that [the patent owner] is not entitled to the benefit” of the earlier priority
`date. Dynamic Drinkware, 800 F.3d at 1379 (citing Tech. Licensing Corp. v.
`Videotek, Inc., 545 F.3d 1316, 1328 (Fed. Cir. 2008)).
`Medtronic, Inc. v. Teleflex Innovations S.A.R.L., IPR2020-00126,
`Paper 127 at 16 (June 27, 2021); Sur-Reply at 1.
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`2
`
`
`
`Rule of Reason
`
`“In the final analysis, each corroboration case must be decided on its own facts
`with a view to deciding whether the evidence as a whole is persuasive.” Berges
`v. Gottstein, 618 F.2d 771, 776 (CCPA 1980)…. “Even the most credible inventor
`testimony is a fortiori required to be corroborated by independent evidence,
`which may consist of documentary evidence as well as the testimony of non-
`inventors.” [Medichem, 437 F.3d ] at 1171–72.
`Medtronic v. Teleflex IPR2020-00126, Paper 127 at 15; Sur-Reply at 2-3.
`“‘In order to corroborate a reduction to practice, it is not necessary to produce an
`actual over-the-shoulder observer. Rather, sufficient circumstantial evidence of
`an independent nature can satisfy the corroboration requirement.’ Cooper, 154
`F.3d at 1330…. Put another way, the law ‘does not require that evidence have a
`source independent of the inventors on every aspect of conception and
`reduction to practice; such a standard is the antithesis of the rule of reason.’ E.I.
`du Pont De Nemours & Co. v. Unifrax I LLC, 921 F.3d 1060, 1077 (Fed. Cir.
`2019) (internal quotation omitted).”
`Medtronic v. Teleflex IPR2020-00126, Paper 127 at 48; Sur-Reply at 2-3.
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`3
`
`
`
`Issues for CRTP
`
` Petitioner Does Not Challenge Prior Conception
` For Actual RTP, Petitioner Challenges:
` Assembly of Prototypes – Resolved in Prior IPRs
` Testing Sufficient to Show Prototypes Would Work for Intended
`Purpose – Resolved in Prior IPRs
` Performance of the Claimed Method in vivo
` For Constructive RTP, Petitioner Challenges
`Diligence – Resolved in Prior IPRs
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`4
`
`
`
`Summary of Reduction to Practice Evidence
`Documents – Nearly 75
`Exhibits, Including:
` Purchase orders, invoices, and
`certificates of completion for
`prototype components
` Assembly drawings for
`prototype proximal and distal
`portions (April and July)
` August engineering drawing
` Sales presentation with pictures
`of coronary model with OTW
`Guideliner
` Draft regulatory documents
` Other company memoranda
`and presentations
`
`Testimony
` Root Declaration and
`Deposition Testimony (Inventor)
` Sutton Declaration (Inventor)
` Erb Declaration and Deposition
`Testimony (VSI Technician)
` Schmalz Declaration (Former
`VSI Regulatory Executive)
` Goemer Declaration (Vendor)
` O’Neil Declaration (Vendor)
` Keith Declaration (Expert)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`5
`
`
`
`CONCEPTION
`CONCEPTION
`
`6
`
`
`
`Sutton Lab Notebook
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2002 at 8-9; e.g. Response at 4-6
`
`7
`
`
`
`Root Notes
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2004 at 1; Response at 6
`
`8
`
`
`
`CORROBORATION OF REDUCTION TO
`PRACTICE – NON-INVENTOR TESTIMONY
`
`9
`
`
`
`Corroborating Witness #1 – Steve Erb
`
`Ex-2122 at ¶ 1; Sur-Reply at 5
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`10
`
`
`
`Erb Testimony
`
`Ex-2122 at ¶ 7;
`Response at 23;
`Sur-Reply at 5
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2110 at 3;
`Response at 23
`
`11
`
`
`
`Erb Testimony
`
`Ex-2122 at ¶¶ 8, 11;
`Response at 22-23;
`Sur-Reply at 5-6
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`12
`
`
`
`Erb Testimony
`
`Ex-2122 at ¶¶ 12-13, 19;
`Response at 20-31;
`Sur-Reply at 5-7, 13-16
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`13
`
`
`
`Erb Testimony
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2122 at ¶ 20;
`Response at 20-24, 33;
`Sur-Reply at 17-19
`
`14
`
`
`
`Corroborating Witness #2 – Deborah Schmalz
`
`Ex-2039 at ¶¶ 1-2; Sur-Reply at 4,5
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`15
`
`
`
`Schmalz Testimony
`
`Ex-2039 at ¶ 5;
`Response at 20-22;
`Sur-Reply at 5, 19
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`16
`
`
`
`Schmalz Testimony
`
`Ex-2039 at ¶ 6;
`Response at 20-22, 34-35;
`Sur-Reply at 19
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2024;
`Response at 22, 34;
`Sur-Reply at 19
`
`17
`
`
`
`Schmalz Testimony
`
`Ex-2039 at ¶ 11;
`Response at 20-22;
`Sur-Reply at 4-5
`
`Ex-2041 at 4;
`Ex-2118 at ¶ 65;
`Response at 35-36
`
`18
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`
`
`Schmalz Testimony
`
`Ex-2039 at ¶ 7;
`Response at 21-22, 34-35;
`Sur-Reply at 4-5, 19
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`19
`
`
`
`Oral Testimony Is Sufficient for All Aspects of
`Reduction to Practice
`
`Under the “rule of reason,” the inventor’s testimony must be sufficiently
`corroborated by independent evidence, but not necessarily
`documentary evidence. Rather, “the rule requires an evaluation
`of all pertinent evidence when determining the credibility of an
`inventor's testimony.” Furthermore, it is not surprising that Loral has
`been unable to submit documents showing production test results,
`considering that the events at issue occurred almost 30 years ago.
`Loral Fairchild Corp. v. Matsushita Elec. Indus., 266 F.3d 1358, 1364-65 (Fed. Cir. 2001);
`Sur-Reply at 2-3
`Although no direct evidence supported Goldfarb’s testimony that he
`measured fibril length and observed tissue ingrowth in July of 1973, we
`agree with the Board that circumstantial evidence provided sufficient
`corroboration. Goldfarb testified that he examined fibril length at the
`time of the successful implant. His testimony was corroborated by the
`testimony of Mendenhall and Green.
`Cooper v. Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998);
`Sur-Reply at 2-4
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`20
`
`
`
`CORROBORATION OF REDUCTION TO
`PRACTICE – DOCUMENTARY
`CORROBORATION
`
`21
`
`
`
`Market Feasibility Memo (Feb. 2005)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2127 at 1;
`Response at 19
`
`22
`
`
`
`Market Feasibility Memo (Feb. 2005)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2127 at 2;
`Response at 19
`
`23
`
`
`
`April Prototypes – Proximal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2013;
`Response at 22-26
`
`24
`
`
`
`April Prototypes – Proximal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2095;
`Response at 22-26
`
`25
`
`
`
`April Prototypes – Proximal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2113 at 2;
`Response at 20-26;
`Sur-Reply at 6-7
`
`26
`
`
`
`April Prototypes – Distal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2011 at 2;
`Response at 20-24
`
`27
`
`
`
`April Prototypes – Distal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2089 at 8;
`Response at 20-26, 31;
`Sur-Reply at 6-7
`
`28
`
`
`
`July Prototypes – Proximal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2020 at 4;
`Response at 24-26, 28-30
`
`29
`
`
`
`July Prototypes – Proximal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2111 at 1-2;
`Response at 24-26, 28-29
`
`30
`
`
`
`July Prototypes – Proximal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2114;
`Response at 24-26, 28-29;
`Sur-Reply at 5-7
`
`31
`
`
`
`July Prototypes – Distal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2021 at 2;
`Response at 24, 28-30
`
`32
`
`
`
`July Prototypes – Distal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2092 at 8;
`Response at 22-24, 28-29;
`Sur-Reply at 6-7
`
`33
`
`
`
`Zalesky Testimony (Medtronic Expert)
`
`Q. But my question is: Would it be reasonable for VSI to spend thousands
`of dollars on customized parts like those shown in 2089, 2113, 2092, and
`2114, would it be reasonable for VSI to not assemble those parts together?
`A. I agree that doesn’t make a lot of sense, but I can certainly conceive of
`using those parts for other purposes, for other potential designs, through
`other exploratory concepts. I just don’t have any evidence that indicates
`how they were used or that they were assembled into any prototype.
`
`Ex-2237 at 208:10-25;
`Response at 31
`Sur-Reply at 4-5
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`34
`
`
`
`Prototype Parts Are Designed to Mate
`April Prototype – Distal Portion
`
`April Prototype – Proximal Portion
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex. 2089, Ex. 2113; Response at 31
`
`35
`
`
`
`August 2005 Computer Drawing
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2022;
`Response at 22, 33-35
`
`36
`
`
`
`CORROBORATION OF TESTING
`CORROBORATION OF TESTING
`
`37
`
`
`
`Successful Testing Was Performed – Root Testimony
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2118 at ¶ 18;
`Response at 2, 19, 22-24, 28, 30-32;
`Sur-Reply at 11-13
`
`38
`
`
`
`Root Testimony
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2118 at ¶ 50;
`Response at 21-24, 22, 27-32
`
`39
`
`
`
`Sutton Testimony
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2119 at ¶ 41;
`Response at 22-23, 27-28, 30-33;
`Sur-Reply at 13
`40
`
`
`
`July 2005 “New Products” Powerpoint Shows
`OTW GuideLiner in Heart Model
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`41
`
`Ex-2018 at 12;
`Response at 27-28, 30, 32
`
`
`
`August 2005 Product Requirements (Schmalz)
`
`Ex-2024;
`Response at 22, 34;
`Sur-Reply at 19
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2039 at ¶ 6;
`Response at 20-21, 34;
`Sur-Reply at 4-5
`
`42
`
`
`
`August 2005 Clinical Technical Report
`
`* * *
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2025 at 1, 6;
`Response at 35
`
`43
`
`
`
`August 2005 Clinical Technical Report (Schmalz)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`44
`
`Ex-2039 at ¶ 9;
`Response at 21-22, 35;
`Sur-Reply at 4-5
`
`
`
`Corroborating Testimony - Erb
`
`Q. When you say you were personally involved, what was your role?
`A. I would have been standing there next to whoever was testing. So
`that would have been my personal role. Assisting, I guess would be the
`term.
`Q. You were standing there or you were assisting?
`A. Well, it would have been both. Whatever was required of me being a
`technician. So sometimes I may not -- may not have a role, but I would
`still be there just in case we needed something or -- also, it was
`exciting. I would be there just to see how it worked.
`
`Ex-1756 at 67:6-19; Ex-1799, 36:7-38:15;
`Sur-Reply at 5-6
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`45
`
`
`
`Corroborating Testimony – Schmalz
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2039 at ¶ 11;
`Response at 21-22;
`Sur-Reply at 4-5
`
`46
`
`
`
`No Testing Required When a POSITA Knows the
`Invention Will Work
`
`“Less complicated inventions and problems do not demand stringent
`testing. In fact, some inventions are so simple and their purpose and
`efficacy so obvious that their complete construction is sufficient to
`demonstrate workability.”
`Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578 (Fed. Cir. 1996); Response at 22
`
`“[W]hen the problem to be solved does not present myriad variables,
`common sense similarly permits little or no testing to show the
`soundness of the principles of operation of the invention.”
`Scott v. Finney, 34 F.3d 1058, 1061-63 (Fed. Cir. 1994); Response at 21-22
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`47
`
`
`
`Brecker Testimony (Medtronic Expert)
`
`Q. I really am trying to understand whether the -- the basis for your belief that
`the Itou device that one skilled in the art would -- would believe that it would
`work to provide backup support, and it sounds like the answer to that question
`is –
`A. Yes.
`Q. -- yes, one skilled in the art would believe that opinion?
`A. Yes. One skilled in the art would definitely and firmly believe that putting an
`Itou suction catheter down the coronary artery would give you more support. It
`has to.
`
`* * * *
`Q. Even in 2005 you're saying somebody skilled in the art would have known
`that?
`A. They would have known it because we did -- you know, we -- we used
`longer sheaths to give support to the guide catheter. Wherever you had
`something inside something else, it was more supportive, inherently so.
`Ex-2116 at 113:2-24;
`Response at 22;
`Sur-Reply at 15
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`48
`
`
`
`Jones Testimony (Medtronic Expert)
`
`Q. Okay. Same question with respect to the Itou
`device. Do you agree that a person of skill in the art
`would know that the Itou device would improve backup
`support?
`A. Yes. Again, in the Itou device, they show a guide
`catheter with a suction catheter within it. And the
`combination would increase backup support.
`
`Ex-2241 at 86:21-87:2;
`Response at 22, 32
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`49
`
`
`
`Petitioner’s Assertion of Inherency Obviates
`Need for Testing Evidence
`
`“Petitioners further argue that Patent Owner’s antedation evidence
`fails to establish that HuMAb4D5-5 and HuMAb4D5-8 would work
`for their intended purpose…. Although Patent Owner sufficiently
`documents the binding properties of HuMAb4D5-5 and HuMAb4D5-
`8 (see PO Resp. 39–40), Petitioners argue that Patent Owner fails
`to provide any evidence of immunogenicity testing.
`* * * *
`Petitioners’ argument is also undercut by their assertion that
`‘immunogenicity compared to a non-human parent [is] an inherent
`aspect of the claimed humanized antibodies.’ In light of Petitioners’
`admission, HuMAb4D5-5 and HuMAb4D5-8 would necessarily have
`such “reduced immunogenicity.”
`Pfizer, Inc. v. Genentech, Inc., IPR2017-01488, Paper 87 at 23-24
`(PTAB, Nov. 29, 2018); Response at 32
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`50
`
`
`
`Testing in a Heart Model Was Sufficient
`
`“For medical device inventions, a showing of actual reduction to
`practice does not require human testing in actual use conditions.”
`IPR2020-00126, Paper 129 at 56
`(citing Scott v. Finney, 34 F.3d 1058, 1063 (Fed. Cir. 1994))
`
`“Dr. Mahurkar designed these tests to show the efficiency of his
`structure knowing that polyethylene catheters were too brittle for
`actual use with humans. But, he also knew that his invention would
`become suitable for its intended purpose by simple substitution of a
`soft, biocompatible material. Dr. Mahurkar adequately showed
`reduction to practice of his less complicated invention with tests
`which did not duplicate all of the conditions of actual use.”
`Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578 (Fed. Cir. 1996); Response at 21-22
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`51
`
`
`
`Keith Testimony (Teleflex Expert)
`
`* * * *
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2123 at ¶¶ 21, 23;
`Response at 22, 31
`
`52
`
`
`
`Quantitative Test Results Are Not Required
`
`Under the “rule of reason,” the inventor’s testimony must be sufficiently
`corroborated by independent evidence, but not necessarily
`documentary evidence.
`Loral Fairchild Corp. v. Matsushita Elec. Indus., 266 F.3d 1358, 1364-65 (Fed. Cir. 2001);
`Sur-Reply at 2-3
`
`Although no direct evidence supported Goldfarb’s testimony that he
`measured fibril length and observed tissue ingrowth in July of 1973, we
`agree with the Board that circumstantial evidence provided sufficient
`corroboration.
`
`Cooper v. Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998);
`Sur-Reply at 2-4
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`53
`
`
`
`Keith Testimony (Teleflex Expert)
`
`Ex-2123 at ¶ 22;
`Response at 22, 31
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`54
`
`
`
`Time or Changes Prior To Commercialization Do
`Not Disprove RTP
`
`“Once the invention has been shown to work for its intended
`purpose, reduction to practice is complete. Further efforts to
`commercialize the invention are simply not relevant to determining
`whether a reference qualifies as prior art against the patented
`invention.”
`
`Loral Fairchild Corp. v. Matsushita Elec. Indus., 266 F.3d 1358, 1362-63 (Fed. Cir. 2001);
`Response at 36; Sur-Reply at 19-20
`
`“We do not find that the additional engineering and design work
`done with respect to the GuideLiner RX to achieve regulatory
`approval and commercialization indicates a lack of actual reduction
`to practice prior to the critical date.”
`
`IPR2020-00126, Paper 129 at 61.
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`55
`
`
`
`Formal Testing on OTW Device Was for FDA
`Purposes
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-1760, p. 86;
`Reply at 10
`
`56
`
`
`
`Zalesky Testimony (Medtronic Expert)
`
`Q. And is the testing that’s required for a 510(k) the same testing that is
`required to show reduction to practice for patentability?
`A. No, no, no, no, no. The testing requirement for regulatory submission such
`as a 510(k) is quite extensive. It requires detailed protocols. It requires
`statistical significance in most cases. It requires formal biocompatibility. It
`requires additional tests.
`So it’s a – it’s a very significantly different level than that required to
`demonstrate reduction to practice.
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`57
`
`Ex-2237 at 63:23-64:9, Sur-Reply at 4
`
`
`
`Root Testimony
`
`Ex-2118 at ¶ 91;
`Response at 33, 35-36;
`Sur-Reply at 19-20
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`58
`
`
`
`Keith Testimony (Teleflex Expert)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`59
`
`Ex-2123 at ¶ 25;
`Response at 31, 33, 35-36
`
`
`
`Root Testimony
`
`Ex-2118 at ¶ 68;
`Response at 33, 35-36;
`Sur-Reply at 19-20
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`60
`
`
`
`Post-Conception Work Was for Commercialization
`
`Ex-2118 at ¶ 73; Ex-2115;
`Response at 33, 35-36; Sur-Reply at 19-20
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`61
`
`
`
`Personnel Changes
`
`Root Declaration
`
`Sutton Declaration
`
`Ex-2118 at ¶ 90;
`Response at 33, 35-36;
`Sur-Reply at 19-20
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2119 at ¶ 6;
`Response at 35-36
`
`62
`
`
`
`THE PROTOTYPES PRACTICED
`THE PROTOTYPES PRACTICED
`THE CLAIMED INVENTION
`THE CLAIMED INVENTION
`
`63
`
`
`
`Annotated MED Drawing
`
`Response at 25
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`64
`
`
`
`Annotated MED Drawing
`
`Response at 25-26
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`65
`
`
`
`Annotated MED Drawing
`
`Response at 26
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`66
`
`
`
`Annotated Spectralytics Drawing
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Response at 27
`
`67
`
`
`
`Annotated Spectralytics Drawing
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Response at 29
`
`68
`
`
`
`Patent Figures
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`69
`
`Response at 29-30
`
`
`
`August 2005 Annotated Drawing
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`70
`
`Response at 34
`
`
`
`Patent Figures
`
`Response at 34
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`71
`
`
`
`Annotated April Prototypes
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Response at 25-27
`
`72
`
`
`
`Annotated July Prototypes
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Response at 29
`
`73
`
`
`
`Annotated Computer Drawing
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Response at 34
`
`74
`
`
`
`Zalesky Testimony (Medtronic Expert)
`
`Q. So with respect to your opinion on construction and reduction to practice,
`you have not formed an opinion about what the claim terms mean; is that
`correct?
`A. That’s correct.
`Q. So when you say, for example, the prototype that Mr. Root speaks of didn’t
`have a particular claim element, you’re not basing that understanding -- or
`basing that opinion on any understanding of what the claim element means.
`You’re just saying that Mr. Root hasn’t corroborated his opinion.
`Is that your -- is that what you’ve done with your report here? . . .
`[A.] Yes, that’s correct.
`
`Ex-2237 at 216:8-12, 216:13-21, 216:24;
`Response at 31
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`75
`
`
`
`Zalesky Testimony (Medtronic Expert)
`
`[A.] But all of my rebuttal comments are very specific to Mr.
`Root’s assertions, and largely depend on my absence of
`evidence introduced regarding an actual prototype and
`actual testing of the prototype for its intended use.
`Q. So you’re not applying any understanding that you may
`have of the claim terms in forming --
`A. That’s correct.
`Q. -- your opinions?
`That’s correct?
`
`A. Yes.
`
`Ex-2237 at 218:1-12;
`Response at 31
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`76
`
`
`
`Teleflex Need Not Show Any More Than Shown
`in Itou
`
`“Alternatively, to the extent Petitioners are incorrect about the inherency
`of reduced immunogenicity, neither Kurrle nor Queen 1990 provides
`evidence of immunogenicity testing, and Patent Owner has antedated
`as much of the claimed invention as shown in those references. See In
`re Stempel, 241 F.2d 755, 759 (1957) (“all the applicant can be required
`to show is priority with respect to so much of the claimed invention as
`the reference happens to show. When he has done that he has
`disposed of the reference”); In re Stryker, 435 F.2d 1340, 1341 (1971).”
`
`Pfizer, Inc. v. Genentech, Inc., IPR2017-01488, Paper 87 at 24
`(PTAB, Nov. 29, 2018);
`Response at 32
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`77
`
`
`
`DILIGENCE FROM CRITICAL
`DILIGENCE FROM CRITICAL
`DATE TO PATENT FILING
`DATE TO PATENT FILING
`
`78
`
`
`
`Diligence Need only Be Reasonably Continuous,
`Showing Invention Was Not Abandoned
`
`[D]iligence need not be perfectly continuous—only reasonably
`continuous. [P]eriods of inactivity within the critical period do not
`automatically vanquish a patent owner's claim of reasonable
`diligence. [T]he point of the diligence analysis is not to scour the
`patent owner’s corroborating evidence in search of intervals of time
`where the patent owner has failed to substantiate some sort of
`activity. Rather, the adequacy of the reduction to practice is
`determined by whether, in light of the evidence as a whole, the
`invention was not abandoned or unreasonably delayed.
`
`Arctic Cat Inc. v. GEP Power Prods., 919 F.3d 1320, 1331 (Fed. Cir. 2019);
`Response at 36
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`79
`
`
`
`Evidence Shows Reasonable Diligence
`Root Testimony
`
`Ex-2118 at ¶ 62;
`Response at 36-37; Sur-Reply at 17-19
`Schmalz Testimony
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2039 at ¶ 12;
`Response at 20-22, 35-36
`
`80
`
`
`
`September 14, 2005
`
`Evidence Shows Reasonable Diligence
`Date
`Corroborating Evidence Showing Diligence
`August 2005
`VSI patent counsel performs patent search related to
`GuideLiner (Ex-2096 at 8)
`VSI patent counsel opens patent search for GuideLiner (Ex-
`2023 at 5)
`VSI patent counsel reports results of patent search related
`to GuideLiner (Ex-2098 at 2)
`Report to the VSI Board on favorable physician feedback
`regarding GuideLiner, and plan for 510(k) regulatory
`submission for Rx version in 1st quarter 2006 (Ex-2133 at 4,
`7)
`VSI patent counsel opens patent prosecution matter for
`GuideLiner (Ex-2023 at 5)
`GuideLiner Narrow SST-02 Flatt Pattern engineering
`drawing created (Ex-2019 at 2)
`Gregg Sutton reported that for Rx GuideLiner VSI planned to
`complete design verification testing in June 2006 and to
`submit an FDA application in July 2006 (Ex-2099)
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`November 22, 2005
`
`81
`
`August 11, 2005
`
`October 2005
`
`October 10, 2005
`
`November 1, 2005
`
`
`
`Evidence Shows Reasonable Diligence
`
`Date
`December 2005
`
`December 1, 2005
`
`January 2006
`
`January 23, 2006
`
`March 2006
`
`March 15, 2006
`
`March 21, 2006
`
`Corroborating Evidence Showing Diligence
`VSI patent counsel performs patent work related to
`GuideLiner (Ex-2117 at 20)
`Gregg Sutton reports to VSI Board that additional
`engineering work would be done on Rx GuideLiner (Ex-2100
`at 8-9)
`VSI patent counsel performs patent work related to
`GuideLiner (Ex-2101 at 7)
`Gregg Sutton sends fax with GuideLiner sketches to VSI
`patent counsel (Ex-2102)
`VSI patent counsel performs patent work related to
`GuideLiner (Ex-2103 at 6)
`Email exchange between Howard Root and patent counsel
`regarding GuideLiner patent application (Ex-2098 at 4)
`Gregg Sutton sends rapid exchange GuideLiner component
`drawings to VSI patent counsel (Ex-2019)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`82
`
`
`
`Evidence Shows Reasonable Diligence
`
`Date
`March 24, 2006
`
`March 30, 2006
`
`April 2006
`
`April 7, 2006
`
`April 18, 2006
`
`April 19, 2006
`
`Corroborating Evidence Showing Diligence
`Vita Needle ships 600 feet of stainless steel tubing for
`GuideLiner project (Ex-2104)
`Hypo Tube, Cut GuideLiner engineering drawing created
`(Ex-2115)
`Budget to Actual Variances report shows significantly higher
`spend on GuideLiner compared to budget, most of which Mr.
`Root said was for Rx GuideLiner (Ex-2105 at 4-5; Ex-2118
`at ¶ 74)
`Shipping invoice from LSA for laser cut and electro-polished
`GuideLiner parts (Ex-2106 at 3)
`Shipping invoice from MicroGroup to Steve Erb for
`hypotubing related to GuideLiner (Ex-2107)
`Shipping invoice from LSA for cut GuideLiner hypotubes
`(Ex-2108 at 4-5)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Response at 22, 35-37; Sur-Reply at 17-19
`
`83
`
`
`
`Itou-Based Challenges
`
`• IPRR2020-01341 (All grounds, all
`challenged claims of the ‘413 patent)
`
`• IPR2020-01343 (Grounds 2 and 3, all
`challenged claims of the ‘116 patent)
`
`Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A.
`Attorney-Client Privileged & Work Product
`
`84
`
`
`
`Itou
`(Ex-1007)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-1009, Figs. 1-4, 7:1-27
`
`85
`
`
`
`2)
`3)
`
`Itou-based IPRs: OUTLINE
`• No Anticipation (‘413 patent (-01341 IPR), Ground 1)
`Itou does not anticipate the only independent claim of ‘413 patent
`•
`1)
`Itou’s “protective catheter” ≠ “interventional cardiology device” in view of ’413
`specification
`Itou’s protective catheter is not inserted “into contact with or past a lesion”
`Itou’s protective catheter is not inserted after coaxial guide catheter (Itou’s
`suction catheter is pre-loaded with the protective catheter)
`• Non-Obvious (‘413 patent (-01341 IPR), Grounds 1-2; ‘116 patent (-01343 IPR), Ground 2)
`Independent claims of ‘413 and ‘116 patents not obvious:
`•
`•
`Itou alone
`-01341 IPR, Ground 2 (‘413 patent, independent claim 1)
`Itou + Ressemann
`-01341 IPR, Ground 3 (‘413 patent, independent claim 1)
`-01343 IPR, Ground 2 (‘116 patent, independent claim 25
`• Dependent claims 2 and 9-12 of ‘413 patent
`-01341 IPR, Grounds 1, 2, 3
`
`•
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`86
`
`
`
`Itou-based IPRs: No Anticipation
`(-01341 IPR, Ground 1)
`
`Independent claim 1 (‘413 patent) not anticipated
`1. A method of providing backup support for an interventional
`cardiology device for use in the coronary vasculature, . . . the method
`comprising: . . .
`inserting a flexible tip portion of a coaxial guide catheter . . . into the
`continuous lumen of the standard guide catheter, and,
`further inserting a substantially rigid portion . . . into the continuous
`lumen of the standard guide catheter, . . .
`advancing a distal portion of the flexible tip portion distally beyond
`the distal end of the standard guide catheter and into the second artery
`. . . ;
`and inserting the interventional cardiology device into and through
`the continuous lumen of the standard guide catheter alongside of the
`substantially rigid portion and advancing the interventional
`cardiology device through and beyond a lumen of the flexible tip
`portion into contact with or past a lesion in the second artery.
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`87
`
`
`
`Itou-based IPRs: No Anticipation
`(-01341 IPR, Ground 1)
`
`Independent claim 1 (‘413 patent) not anticipated
`
`1)
`
`Itou’s “protective catheter” ≠ “interventional
`cardiology device” in view of ‘413 specification
`
`‘413 patent, Ex-1001, 9:65-10:3
`
`‘413 patent, Ex-1001, 4:35-38
`
`‘413 patent, Ex-1001, 1:23-26
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`IPR2020-01341, Paper 24 at 14-16, 37-40
`
`88
`
`
`
`Itou-based IPRs: No Anticipation
`(-01341 IPR, Ground 1)
`
`Independent claim 1 (‘413 patent) not anticipated
`
`1)
`
`Itou’s “protective catheter” ≠ “interventional
`cardiology device” in view of ‘413 specification
`
`‘413 patent – “tapered inner catheter 14”
`
`Itou – “protective catheter 5”
`
`Ex-1001, Fig. 1
`
`Ex-1007, Fig. 1E
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`IPR2020-01341, Paper 24 at 14-16, 37-40
`
`89
`
`
`
`Itou-based IPRs: No Anticipation
`(-01341 IPR, Ground 1)
`
`Independent claim 1 (‘413 patent) not anticipated
`
`1)
`
`Itou’s “protective catheter” ≠ “interventional
`cardiology device” in view of ‘413 specification
`Dr. Graham (Ex-2145, ¶101):
`Itou (Ex-1007, 4:48-60):
`
`‘413 patent (Ex-1001, 2:62-68):
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`IPR2020-01341, Paper 24 at 14-16, 37-40
`
`90
`
`
`
`Itou-based IPRs: No Anticipation
`(-01341 IPR, Ground 1)
`
`Independent claim 1 (‘413 patent) not anticipated
`
`1)
`
`Itou’s “protective catheter” ≠ “interventional
`cardiology device” in view of ‘413 specification
`Petitioner’s expert Dr. Brecker did not even consider ‘413
`patent specification:
`
`(Ex-2260, 64:11-65:13)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`IPR2020-01341, Paper 67 at 21
`
`91
`
`
`
`Itou-based IPRs: No Anticipation
`(-01341 IPR, Ground 1)
`
`Independent claim 1 (‘413 patent) not anticipated
`
`2) Itou’s protective catheter is not inserted “into contact
`with or past a lesion”
`
`Itou:
`
`“thrombus” ≠ “lesion”
`
`(Ex-1007, 7:1-27)
`
`Itou’s protective catheter ≠
`contact any lesion or thrombus
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`IPR2020-01341, Paper 24 at 39-40
`
`92
`
`
`
`Itou-based IPRs: No Anticipation
`(-01341 IPR, Ground 1)
`
`Independent claim 1 (‘413 patent) not anticipated
`
`3) Itou’s protective catheter is not inserted after coaxial
`guide catheter
`
`First step: “look to the claim language to
`determine if, as a matter of logic or grammar,
`they must be performed in the order written.”
`Altiris, Inc. v. Symantec Corp., 318 F.3d 1363,
`1369-70 (Fed. Cir. 2003)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`IPR2020-01341, Paper 24 at 9-14, 40
`
`93
`
`
`
`Itou-based IPRs: No Anticipation
`(-01341 IPR, Ground 1)
`
`Independent claim 1 (‘413 patent) not anticipated
`3) Itou’s protective catheter is not inserted after coaxial
`guide catheter
`Claim 1: “A method of providing backup support … the method comprising:”
`1.a. “…inserting the standard guide catheter..”
`1.b. “…positioning the distal end of the standard guide catheter in a branch
`artery …”
`1.c. “...inserting a flexible tip portion of a coaxial guide catheter . . .
`1.d.i. “…and, further inserting a substantially rigid portion . . . into the
`continuous lumen of the standard guide catheter, . . .
`1.e. “…advancing a distal portion of the flexible tip portion distally beyond the
`distal end of the standard guide catheter and into the second artery . . . “
`1.f. “and inserting the interventional cardiology device into and through the
`continuous lumen of the standard guide catheter alongside of the substantially
`rigid portion and advancing the interventional cardiology device through and
`beyond a lumen of the flexible tip portion into contact with or past a lesion in
`the second artery.
`
`ALL experts
`agree these
`steps must be
`performed in
`order
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`IPR2020-01341, Paper 24 at 10-11
`
`94
`
`
`
`Itou-based IPRs: No Anticipation
`(-01341 IPR, Ground 1)
`
`Independent claim 1 (‘413 patent) not anticipated
`3) Itou’s protective catheter is not inserted after coaxial
`guide catheter
`Petitioner’s expert Dr. Hillstead:
`
`[…]
`
`Patent Owner’s two experts
`agree – inserting the ICD
`“alongside” the substantially
`rigid portion means
`substantially rigid portion
`already in place:
` Dr. Graham: Ex-2145, ¶103
` Mr. Keith: Ex-2138, ¶103
`
`(Ex-2244, 62:18-24 and 63:6-64:1)
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`IPR2020-01341, Paper 24 at 11
`
`95
`
`
`
`Itou-based IPRs: No Anticipation
`(-01341 IPR, Ground 1)
`
`Independent claim 1 (‘413 patent) not anticipated
`
`3) Itou’s protective catheter is not inserted after coaxial
`guide catheter
`Second step: “look to the rest of the
`specification to determine whether it ‘directly or
`implicitly requires such a narrow construction’ ”
`Altiris, Inc. v. Symantec Corp., 318 F.3d 1363,
`1369-70 (Fed. Cir. 2003)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`IPR2020-01341, Paper 24 at 13-14, 40
`
`96
`
`
`
`Itou-based IPRs: No Anticipation
`(-01341 IPR, Ground 1)
`
`Independent claim 1 (‘413 patent) not anticipated
`
`3) Itou’s protective catheter is not inserted after coaxial
`guide catheter
`‘413 patent specification
`describes order of insertion
`(Ex-1001, 9:51-10:3):
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`IPR2020-01341, Paper 24 at 13-14, 40
`
`97
`
`
`
`2)
`3)
`
`Itou-based IPRs: OUTLINE
`• No Anticipation (‘413 patent (-01341 IPR), Ground 1)
`Itou does not anticipate the only independent claim of ‘413 patent
`•
`1)
`Itou’s “protective catheter” ≠ “interventional cardiology dev