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
`
`
`
`Outline
`
` Conception
` Corroboration of Reduction to Practice
` Non-Inventor Testimonial Corroboration
` Documentary Corroboration
` Corroboration of Testing
` The Prototypes Practiced the Claimed Invention
` Patent Owner Was Diligent Through May 2006
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`2
`
`
`
`Petitioner Bears the Burden of Persuasion on CRTP
`
`Although the burden of production can be a shifting burden, we note
`that the burden of persuasion is on Petitioner to ultimately prove
`“unpatentability by a preponderance of the evidence,” and that this
`burden never shifts to Patent Owner.
`Motorola Mobility LLC v. Intellectual Ventures II LLC, IPR2014-00504,
`Paper 84 at 14-15 (PTAB Mar. 13, 2020); Sur-Reply at 2
`
`THE COURT: Mr. Morton, the last point you said on the issue where
`Petitioner bears the burden, is it your understanding
`that you bear the burden on the conception and
`reduction to practice issue?
`MR. MORTON: Yes, your Honor, once they’ve called into question, set
`it forth and made their case, the ultimate burden is on
`us.
`
`Ex-1099, 12:18-25; Sur-Reply at 2
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`3
`
`
`
`Rule of Reason
`
`“In assessing corroboration of oral testimony, courts apply a rule of
`reason analysis. Under a rule of reason analysis, an evaluation of all
`pertinent evidence must be made so that a sound determination of the
`credibility of the inventor’s story may be reached.”
`Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578 (Fed. Cir. 1996); e.g. Response at 20-21, 25, 27
`
`“But our case 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.’ Here, the law requires only that the corroborative evidence,
`including circumstantial evidence, support the credibility of the
`inventors’ story.”
`
`E.I. du Pont de Nemours & Co. v. Unifrax I LLC, 921 F.3d 1060, 1077
`(Fed. Cir. 2019) (internal citations omitted); Response at 22; Sur-Reply at 6, 8
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`4
`
`
`
`CONCEPTION
`
`CONCEPTION
`
`5
`
`
`
`Conception Is Relevant Only If No Actual RTP
`Before the Critical Date
`
`To antedate (or establish priority) of an invention, a party must show
`either an earlier reduction to practice, or an earlier conception
`followed by a diligent reduction to practice.
`Purdue Pharma L.P. v. Boehringer Ingelheim GmbH, 237 F.3d 1359, 1365
`(Fed. Cir. 2001); Response at 19-20
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`6
`
`
`
`Sutton Lab Notebook
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2002 at 8-9; e.g. Response at 4-6
`
`7
`
`
`
`Market Feasibility Memo (Feb. 2005)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2003 at 1; Ex-2127;
`Response at 6;
`Sur-Reply at 9
`
`8
`
`
`
`Business Records Need No Corroboration
`
`This court does not require corroboration where a party seeks to prove
`conception through the use of physical exhibits. The trier of fact can
`conclude for itself what documents show, aided by testimony as to what
`the exhibit would mean to one skilled in the art.
`Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578 (Fed. Cir. 1996);
`Sur-Reply at 3
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`9
`
`
`
`Root Notes and Patent
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2004 at 1; Response at 6
`
`10
`
`
`
`Root Notes
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2004 at 3; Response at 4
`
`11
`
`
`
`August 2005 Computer Drawing
`
`Zalesky Testimony
`Q: So you would agree that Exhibit 2022 sets forth the concept for
`the rapid exchange GuideLiner, right? . . .
`THE WITNESS: The concept, yes.
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2022; Ex-2237 at 250:9-1, 250:13;
`Response at 16; Sur-Reply at 5
`
`12
`
`
`
`CORROBORATION OF REDUCTION TO
`PRACTICE – NON-INVENTOR TESTIMONY
`
`13
`
`
`
`Corroborating Witness #1 – Steve Erb
`
`Ex-2122 at ¶ 1; Sur-Reply at 10
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`14
`
`
`
`Erb Testimony
`
`Ex-2122 at ¶ 7;
`Response at 7;
`Sur-Reply at 10
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2110 at 3;
`Response at 7;
`Sur-Reply at 10
`
`15
`
`
`
`Erb Testimony
`
`Ex-2122 at ¶¶ 8, 10;
`Response at 7, 22;
`Sur-Reply at 8, 10
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`16
`
`
`
`Erb Testimony
`
`Ex-2122 at ¶¶ 11-12;
`Response at 7-8, 11-12, 15, 22-23;
`Sur-Reply at 8, 10
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`17
`
`
`
`Erb Testimony
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`18
`
`Ex-2122 at ¶ 13;
`Response at 7, 19, 22-23;
`Sur-Reply at 11
`
`
`
`Corroborating Witness #2 – Deborah Schmalz
`
`Ex-2039 at ¶¶ 1-2; Response at 2
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`19
`
`
`
`Schmalz Testimony
`
`Ex-2039 at ¶ 5;
`Response at 23;
`Sur-Reply at 8, 10
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`20
`
`
`
`Schmalz Testimony
`
`Ex-2039 at ¶ 6;
`Response at 3, 17, 22-24;
`Sur-Reply at 8, 10
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2024;
`Response at 17;
`Sur-Reply at 9-10
`
`21
`
`
`
`Schmalz Testimony
`
`Ex-2039 at ¶ 11;
`Response at 3, 23;
`Sur-Reply at 8
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2041 at 4;
`Ex-2118 at ¶ 62;
`Response at 2, 18-19
`
`22
`
`
`
`Schmalz Testimony
`
`Ex-2039 at ¶ 7;
`Response at 3, 22-24;
`Sur-Reply at 8, 10
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`23
`
`
`
`Zalesky Testimony (Medtronic Expert)
`
`Q. You’re not saying that Mr. Root is lying in his declaration, are you?
`A. No, I’m not saying that.
`Q. And you’re not saying that Mr. Sutton is lying in his declaration, are you?
`A. No.
`Q. And you’re not saying that Mr. Sutton lied in his deposition testimony, are you?
`A. No.
`Q. You’re not saying Mr. Erb lied in his declaration, are you?
`A. No.
`Q. And you’re not saying that Mr. Erb lied in his deposition testimony, are you?
`A. No.
`Q. And you’re not saying that Ms. Schmalz lied in her declaration, are you?
`A. No.
`Q. And you’re not saying that Ms. Schmalz lied in her deposition testimony, are you?
`A. No.
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2237 at 139:5-25, see also 225:8-11, 227:14-17;
`Sur-Reply at 8
`
`24
`
`
`
`Zalesky Testimony (Medtronic Expert)
`
`Q. So it’s your testimony that there
`must be some tangible form of a
`written record for an electronic record
`in order for an inventor to show that his
`or her invention works for its intended
`purpose?
`A. Essentially, yes. There needs to be
`some statement of what’s driving what
`he’s making.
`Q. And that has to be written down in
`an electronic or paper record; is that
`right?
`A. It needs to be recorded somewhere,
`otherwise third parties are clueless,
`yes.
`
`Ex-2237 at 253:15-25;
`Response at 24
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Q. And in your opinion, the evidence that
`must accompany the testimony has to be
`in written form, correct?
`A. It needs to be in recorded form. It
`could be photographic. It could be
`electronic, digital.
`
`Ex-2237 at 140:15-18
`Response at 24
`
`Q. And so is it your opinion that because
`there isn’t a photograph, et cetera, that
`reduction to practice of the GuideLiner
`rapid exchange did not, in fact, occur?
`***
`A. Yes, that’s my opinion.
`
`Ex-2237 at 142:20–143:1
`Response at 24
`
`25
`
`
`
`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);
`Response at 24; Sur-Reply at 10
`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);
`Response at 24; Sur-Reply at 8
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`26
`
`
`
`CORROBORATION OF REDUCTION TO
`PRACTICE – DOCUMENTARY
`CORROBORATION
`
`27
`
`
`
`Market Feasibility Memo (Feb. 2005)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2003 at 1;
`Response at 7;
`Sur-Reply at 9
`
`28
`
`
`
`Market Feasibility Memo (Feb. 2005)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2003 at 2;
`Response at 7;
`Sur-Reply at 9
`
`29
`
`
`
`April Prototypes – Proximal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2013;
`Response at 7, 10
`
`30
`
`
`
`April Prototypes – Proximal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2095;
`Response at 7, 10
`
`31
`
`
`
`April Prototypes – Proximal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2113 at 2;
`Response at 8, 10-11;
`Sur-Reply at 5-8, 13
`
`32
`
`
`
`April Prototypes – Distal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2011 at 2;
`Response at 7-8
`
`33
`
`
`
`April Prototypes – Distal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2089 at 8;
`Response at 7-10, 10-11;
`Sur-Reply at 7-8, 13
`
`34
`
`
`
`July Prototypes – Proximal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2020 at 4;
`Response at 7, 13
`
`35
`
`
`
`July Prototypes – Proximal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2095 at 1-2;
`Response at 7, 10;
`
`36
`
`
`
`July Prototypes – Proximal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2114;
`Response at 7-8 13-14;
`
`37
`
`
`
`July Prototypes – Distal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2021 at 2;
`Response at 7, 13
`
`38
`
`
`
`July Prototypes – Distal Section
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2092 at 8;
`Response at 7, 13;
`Sur-Reply at 7-8, 14
`
`39
`
`
`
`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.
`Q. And you don’t have any evidence that those parts were, in fact, used for
`another purpose, do you?
`A. I do not have that evidence.
`
`Ex-2237 at 208:14-209:4;
`Sur-Reply at 8, 15
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`40
`
`
`
`Zalesky’s Speculation
`
`Q. So what you’re displaying in paragraph 165 of
`your declaration is a 5-millimeter section, right?
`A. Yes.
`Q. And that is significantly smaller, is it not, than
`the 20-centimeter segment that is shown in
`Exhibit 2113?
`A. Yes, it is.
`Ex-1755 at ¶¶ 164-165; Ex-2237 at 172:19-25;
`Reply at 16;
`Sur-Reply at 7
`
`41
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`
`
`Zalesky Testimony (Medtronic Expert)
`
`A. I should point out that the exhibit we were looking at just
`prior, 1763, is, in fact, labeled OTW.
`Q. That's right. And it’s got a Pebax -- a series of Pebax tubing
`that is 43 inches, correct?
`A. Right.
`Q. But that’s not the same part that’s shown in Exhibit 2089
`because the exhibit shown in 2089 is only 11.8 inches, right?
`A. Right.
`Q. So these are, in fact, two very different parts?
`A. They probably are.
`
`Ex-2237 at 167:7-19;
`Sur-Reply at 6-7
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`42
`
`
`
`Prototype Parts Are Designed to Mate
`April Prototype – Distal Portion
`
`April Prototype – Proximal Portion
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex. 2089, Ex. 2113; Response at 9-11
`
`43
`
`
`
`CORROBORATION OF TESTING
`
`CORROBORATION OF TESTING
`
`44
`44
`
`
`
`Successful Testing Was Performed – Root Testimony
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2118 at ¶ 18;
`Response at 7-8, 11-12, 15, 22, 25;
`Sur-Reply at 10
`
`45
`
`
`
`Root Testimony
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2118 at ¶ 47;
`Response at 11-13, 15, 22, 25
`
`46
`
`
`
`Sutton Testimony
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2119 at ¶ 41;
`Response at 7, 11-12, 15, 22;
`Sur-Reply at 10-11
`47
`
`
`
`April 2005 Purchase of 6F Guide Catheters
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`48
`
`Ex-2016 at 2;
`Response at 12;
`Sur-Reply at 17-18
`
`
`
`July 2005 “New Products” Powerpoint Shows
`OTW GuideLiner in Heart Model
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`49
`
`Ex-2018 at 12;
`Response at 11-12, 23
`
`
`
`August 2005 Product Requirements (Schmalz)
`
`Ex-2024;
`Response at 17;
`Sur-Reply at 9-10
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2039 at ¶ 6;
`Response at 3, 17, 22-24;
`Sur-Reply at 8, 10
`
`50
`
`
`
`Zalesky Testimony (Medtronic Expert)
`
`Q. Have you personally ever begun the
`process for regulatory approval before you
`knew the product would work for its intended
`purpose?
`A. No, not the formal regulatory process.
`
`Ex-2237 at 64:17-20;
`Sur-Reply at 11
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`51
`
`
`
`August 2005 Clinical Technical Report
`
`* * *
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2025 at 1, 6;
`Response at 17
`
`52
`
`
`
`August 2005 Clinical Technical Report (Schmalz)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`53
`
`Ex-2039 at ¶ 11;
`Response at 17, 22-23;
`Sur-Reply at 8
`
`
`
`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;
`Reply at 20
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`54
`
`
`
`Corroborating Testimony - Erb
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-1756 at 94-95
`
`55
`
`
`
`Corroborating Testimony – Schmalz
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2039 at ¶ 11;
`Response at 3, 23;
`Sur-Reply at 8
`
`56
`
`
`
`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 21, 25
`
`“[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
`
`57
`
`
`
`Brecker Testimony (Medtronic Expert)
`
`Q. Okay. In -- in fact, it’s the opposite. Your opinion is that [Itou’s suction catheter] inherently
`will work to deliver stents.
`A. Yes. I don’t see why it would not.
`Q. Okay. Now -- and -- and that’s not just your opinion, you know, as Dr. Brecker. You think
`one skilled in the art --
`A. Yes.
`Q. -- would -- would recognize that this thing would function to deliver stents inside an artery?
`A. Yes. Yeah. I think if you showed that to a skilled cardiologist around the early to mid 2000s
`or even the late 1990s, they would say yes, that -- you could use that to deliver a stent.
`Q. Okay. And -- and -- and they would say it will work.
`A. They would expect it to work.
`
`* * * *
`Q. Okay. Okay. So -- so as long as the relative sizes were satisfactory, even in 2005, a
`person of skill in the art would believe that a suction catheter like shown in Itou would work to
`deliver stents?
`A. Yes, I think so.
`Q. Even without testing.
`A. I think so.
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2116 at 106:8-24, 109:2-9;
`Response at 25-26
`
`58
`
`
`
`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 26;
`Sur-Reply at 9, 16
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`59
`
`
`
`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;
`Sur-Reply at 9, 16
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`60
`
`
`
`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 12 at 23-24
`(PTAB, Nov. 29, 2018); Sur-Reply at 9, 16
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`61
`
`
`
`Testing in a Heart Model Was Sufficient
`
`“[T]ests performed outside the intended environment can be sufficient to
`show reduction to practice if the testing conditions are sufficiently similar
`to those of the intended environment.”
`DSL Dynamic Scis., Ltd. v. Union Switch & Signal, Inc., 928 F.2d 1122, 1125 (Fed. Cir. 1991);
`Response at 24-25; Sur-Reply at 11
`
`“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, 25
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`62
`
`
`
`Keith Testimony (Teleflex Expert)
`
`* * * *
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2123 at ¶¶ 21, 23;
`Response at 12, 25
`
`63
`
`
`
`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);
`Response at 24; Sur-Reply at 6, 10
`
`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);
`Response at 24; Sur-Replyat 8
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`64
`
`
`
`Keith Testimony (Teleflex Expert)
`
`Ex-2123 at ¶ 22;
`Response at 12, 25
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`65
`
`
`
`Zalesky Testimony (Medtronic Expert)
`
`Q. Can you assess backup support qualitatively?
`A. You can do it both qualitatively and quantitatively.
`
`***
`Q. Is quantitative data required to show intended purpose?
`A. I don’t think it’s necessarily required.
`
`Ex-2237 at 37:11-13, 39:7-9
`Response at 12, 25
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`66
`
`
`
`Time or Changes Prior To Commercialization Do
`Not Disprove RTP
`
`“Reduction to practice does not require that the invention, when
`tested, be in a commercially satisfactory stage of development. . . .”
`Scott v. Finney, 34 F.3d 1058, 1061-63 (Fed. Cir. 1994); Response at 21-22
`
`“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 27; Sur-Reply at 11
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`67
`
`
`
`Formal Testing Followed Proof of Conception
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-1760, p. 86;
`Reply at 10
`
`68
`
`
`
`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.
`
`* * * *
`Q. In other words, there might be more specific FDA requirements, but you’re
`talking in paragraph 55 about FDA testing, not the testing that occurs in the
`earlier phases, right?
`A. Correct. This is much more rigidly controlled testing, where, for instance,
`you can’t just use two or three prototypes. You need to construct a meaningful
`number that will satisfy statistical requirements.
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2237 at 63:23-64:9, 115:21-116:4;
`Sur-Reply at 5, 11
`
`69
`
`
`
`Root Testimony
`
`Ex-2118 at ¶ 90;
`Response at 19, 27;
`Sur-Reply at 11
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`70
`
`
`
`Keith Testimony (Teleflex Expert)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`71
`
`Ex-2123 at ¶ 25;
`Response at 19, 27
`
`
`
`Zalesky Testimony (Medtronic Expert)
`
`Q. Do you have any experience with an invention that you showed would work
`for its intended purpose, for the patentability sense, but then you later made
`design changes?
`A. Oh, that’s quite common, yes.
`
`* * * *
`[Q:] But if the declarants are speaking truthfully, as you have testified they are
`. . . and the prototypes were reduced to practice and tested and shown to
`work for their intended purpose, as they testified the GuideLiner rapid
`exchange prototypes were, it really didn’t matter what VSI did or didn’t do to
`the design after that point for purposes of patentability, did it?
`Once it’s reduced to practice, it’s reduced to practice, right?
`A. Right. If those things actually occurred, then what you just said is correct.
`
`Ex-2237 at 43:22-44:1, 194:22-23, 195:1-11;
`Sur-Reply at 11
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`72
`
`
`
`Root Testimony
`
`Ex-2118 at ¶ 65;
`Response at 19;
`Sur-Reply at 11
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`73
`
`
`
`Post-Conception Work Was for Commercialization
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2118 at ¶ 70; Ex-2115;
`Response at 7-8, 19; Sur-Reply at 11
`
`74
`
`
`
`Personnel Changes
`
`Root Declaration
`
`Ex-2118 at ¶ 89;
`Response at 19; Sur-Reply at 11
`
`Sutton Declaration
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2119 at ¶ 2;
`Response at 2
`
`75
`
`
`
`THE PROTOTYPES PRACTICED
`
`THE PROTOTYPES PRACTICED
`THE CLAIMED INVENTION
`
`THE CLAIMED INVENTION
`
`76
`76
`
`
`
`Annotated MED Drawing
`
`Response at 9
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`77
`
`
`
`Annotated MED Drawing
`
`Response at 9
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`78
`
`
`
`Annotated MED Drawing
`
`Response at 10
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`79
`
`
`
`Annotated Spectralytics Drawing
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Response at 11
`
`80
`
`
`
`Annotated Spectralytics Drawing
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Response at 14
`
`81
`
`
`
`Patent Figures
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`82
`
`Response at 15
`
`
`
`August 2005 Annotated Drawing
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`83
`
`Sur-Reply at 5
`
`
`
`Patent Figures
`
`Response at 16
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`84
`
`
`
`Annotated April Prototypes (‘032 Patent)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Sur-Reply at 13
`
`85
`
`
`
`Annotated July Prototypes (‘032 Patent)
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Sur-Reply at 14
`
`86
`
`
`
`Annotated Computer Drawing
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Sur-Reply at 16
`
`87
`
`
`
`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;
`Sur-Reply at 12, 17
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`88
`
`
`
`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;
`Sur-Reply at 12, 17
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`89
`
`
`
`Zalesky Testimony (Medtronic Expert)
`
`Q. Okay. So then let’s move to Exhibit 2092. And this is the MED distal
`section from the July GuideLiner prototype.
`A. Okay.
`* * * *
`Q. And so there is .1 centimeter of a distal tip that’s not a marker band
`and not annealed braid, right?
`A. Okay.
`Q. Do you agree with that?
`A. Yes.
`
`Ex-2237 at 176:10-13, 179:24-180:4;
`Response at 15
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`90
`
`
`
`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 12 at 24
`(PTAB, Nov. 29, 2018);
`Sur-Reply at 9, 16
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`91
`
`
`
`Brecker Claim Charts (Medtronic Expert)
`
`‘032 Patent, Claim 1
`
`‘032 Patent, Claim 3
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`IPR2020-00126, Ex-1005, ¶¶ 170, 195;
`e.g. Sur-Reply at 17
`
`92
`
`
`
`Brecker Claim Charts (Medtronic Expert)
`
`‘032 Patent, Claim 1
`
`‘776 Patent, Claim 25
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`IPR2020-00126, Ex-1005, ¶ 170; IPR2020-00135, Ex-1005, ¶ 158;
`e.g. IPR2020-00126, Sur-Reply at 17
`
`93
`
`
`
`DILIGENCE FROM CRITICAL
`
`DILIGENCE FROM CRITICAL
`DATE TO PATENT FILING
`
`DATE TO PATENT FILING
`
`94
`94
`
`
`
`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 28
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`95
`
`
`
`Evidence Shows Reasonable Diligence
`Root Testimony
`
`Ex-2118 at ¶ 59;
`Response at 19; Sur-Reply at 11
`Schmalz Testimony
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`Ex-2039 at ¶ 12;
`Response at 19, 23
`
`96
`
`
`
`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
`
`97
`
`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
`
`98
`
`
`
`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, Ex-2005 at 5)
`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 ¶ 71)
`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 2, 7-8, 18-19
`
`99
`
`
`
`Medtronic, Inc. and Medtronic Vascular,
`Inc. v. Teleflex Innovations S.A.R.L.
`
`Patent Owner’s
`Hearing Demonstratives
`(102/103)
`
`Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A.
`Attorney-Client Privileged & Work Product
`
`100
`
`
`
`Claims/Grounds Challenged If Itou is Prior Art
`
`IPR
`
`IPR2020-00126
`
`IPR2020-00128
`
`IPR2020-00129
`
`IPR2020-00132
`
`Separately-Challenged
`Claims
`Independent claims 1, 11
`Dependent claims 3, 6, 13, 14
`Independent claims 1, 12
`Dependent claims 3, 14, 15
`Independent claim 25
`Dependent claims 27, 33
`Dependent claims 32 and 39
`
`IPR2020-00134
`
`None
`
`IPR2020-00135
`
`IPR2020-00137
`
`Independent claims 25, 52, 53
`Dependent claims 32, 36, 37
`Dependent claim 44
`
`Grounds
`
`Grounds 1-2
`
`Grounds 1-2
`
`Grounds 7, 9
`
`Grounds 2-4
`
`None
`
`Grounds 1-5
`
`Grounds 2, 4-5
`
`DEMONSTRATIVE EXHIBIT-NOT EVIDENCE
`
`101
`
`
`
`Petitioner’s Reliance on Itou’s Protective
`Catheter
`
`‘380 Patent, Claim 25:
`“means for receiving the
`interventional device from an
`intermediate or distal portion
`of the means for guiding the
`interventional device to the
`location near the ostium of the
`branch vessel and guiding the
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