Medtronic, Inc. and Medtronic Vascular, Inc. v.
`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
`
`
`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
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
