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`Entered: April 11, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
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`PRAXAIR DISTRIBUTION, INC.
`Petitioner
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`v.
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`MALLINCKRODT HOSPITAL PRODUCTS IP LTD.,
`Patent Owner
`_______________________
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`Case IPR2015-00889
`U.S. Patent No. 8,573,209 B2
`_______________________
`
`Before KEN B. BARRETT, MICHAEL J. FITZPATRICK, AND
`SCOTT A. DANIELS, Administrative Patent Judges.
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`
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
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`Case IPR2015-00889
`U.S. Patent No. 8,573,209
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`I.
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`INTRODUCTION
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`Praxair Distribution, Inc. (“Petitioner”) challenges the validity of United
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`States Patent No. 8,573,209 (“’209 patent,” Ex. 1001) under 35 U.S.C. § 103 on
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`grounds that require the combination of five or more references. Petitioner’s
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`obviousness theories rely extensively—and in many instances are predicated
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`solely—on the declaration of Dr. Robert T. Stone. In his declaration, Dr. Stone
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`offered opinions about the claims of the ’209 patent, what a person of ordinary
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`skill in the art would find obvious, and the purported motivation to combine the
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`disparate references. Unbeknownst to Patent Owner and the Board when it
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`instituted Inter Partes Review, however, Dr. Stone rendered these opinions without
`ever analyzing the claims of the ’209 patent.
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`Patent Owner discovered this fact during Dr. Stone’s deposition when he
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`admitted that he did not analyze the claims of the ’209 patent and disavowed any
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`connection between his opinions and the patent claims:
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`Q. But none of the claimed inventions here had been done exactly as
`claimed by anyone before; correct?
`A. I have not done a claim analysis. So I can’t answer that question
`without doing so.
`Q. Well, when you say you haven’t done a claim analysis, what does
`that mean?
`A. I have not gone element by element through the claims, I have not
`had the claims construed, and I have not prepared a report based on
`that.
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`* * *
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`1
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`Case IPR2015-00889
`U.S. Patent No. 8,573,209
`Q. Did you do any analysis on a claim-by-claim basis?
`A. No, I did not.
`Q. Did you do, for any claims, an analysis on an element-by-element
`basis?
`A. No, I did not.
`(Ex. 2020 at 49:11-24; 56:11-16.)1 In addition to having failed to perform the most
`basic part of any obviousness analysis (i.e., analyzing the patent claims), Dr.
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`Stone’s deposition testimony revealed several other fatal flaws with his opinions,
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`including his failure to apply any recognized legal standards, his use of
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`impermissible hindsight bias, and his failure to consider secondary considerations
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`of non-obviousness, each of which is discussed in more detail below.
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`For all of these reasons, the Board should exclude Dr. Stone’s opinions
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`under Federal Rules of Evidence 402 and 702 as irrelevant and unreliable.
` MOTION TO EXCLUDE AND AUTHORIZATION
`II.
`Pursuant to 37 C.F.R. §§ 42.62 and 42.64(c), as well as the Board’s
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`Scheduling Order (Paper 16), Patent Owner moves to exclude the testimony of
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`Petitioner’s expert, Dr. Robert Stone (Exhibits 1002 and 2020). Patent Owner
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`objected to Dr. Stone’s opinions in its Patent Owner’s Response on December 9,
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`2015, within 5 business days of the facts relevant to this motion being revealed
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`during Dr. Stone’s December 2, 2015 deposition. (See Paper 30 at 19-32.) The
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`Federal Rules of Evidence apply to Inter Partes Review proceedings, and under
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`Rules 402 and 702, the Board should exclude Dr. Stone’s testimony as irrelevant
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`1
`All emphases added and objections omitted unless otherwise noted.
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`2
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`Case IPR2015-00889
`U.S. Patent No. 8,573,209
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`and unreliable. See 37 C.F.R. § 42.62.
` PROCEDURAL BACKGROUND
`III.
`On March 16, 2015, Petitioner filed its Petition for Inter Partes Review
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`(“Petition,” Paper 1). The Petition relied extensively on Dr. Stone’s declaration,
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`citing it more than 100 times. (Exhibit 1002.) In many instances Dr. Stone’s
`declaration is the sole support for Petitioner’s arguments, including the supposed
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`existence of a motivation to combine (see, e.g., Petition at 21 (“A person of
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`ordinary skill in the art would have been motivated to combine [the references] to
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`predictably result in an improved nitric oxide delivery system . . . .”)), and the
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`purported obviousness of certain combinations (see, e.g., id. at 26 (“Combining
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`these sub-portions of a NO delivery system . . . into a single system would
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`predictably result in an improved NO delivery system . . . .”)).
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`Dr. Stone’s declaration opines about how “[o]ne skilled in the relevant art
`would have found it obvious” to combine various references, (Ex. 1002 ¶ 98) and
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`the “motivation to combine” various references. (See, e.g., id. ¶ 109.) The
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`declaration is replete with references to legal terminology such as the expectation
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`of success (id. ¶ 106) and “use of a known technique . . . to obtain predictable
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`results” (id. ¶ 130). Dr. Stone’s declaration also contains statements directed to the
`claims of the ’209 patent: “in my opinion, the architecture disclosed and claimed in
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`the ’209 Patent does not present any new concepts . . . .” (Id. ¶ 60.)
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`3
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`The Board has refused to credit the testimony of Dr. Stone on at least two
`other occasions.2 However, in the instant case, the foregoing statements made it
`appear that Dr. Stone’s testimony was based on his review of the claims and
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`guided by legal principles, and it was reasonable at the time for the Board (and the
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`Patent Owner) to take his opinions at face value. The Board instituted Inter Partes
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`Review in a decision (“Decision,” Paper 14) that relied on Dr. Stone’s declaration.
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`(See, e.g., id. at 7, 10, 16, 17, 19, 20, 21.) However, Patent Owner had not deposed
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`Dr. Stone at the time the Decision issued, and neither the Board nor Patent Owner
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`had any way of knowing what Dr. Stone would later admit at his deposition.
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`Patent Owner deposed Dr. Stone on December 2, 2015, and learned for the
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`first time the extent of the fatal flaws in his analysis. Dr. Stone admitted that he:
`• had “not done an element by element analysis on these patents and/or
`any of the prior art references” (Ex. 2020 at 115:22-24);
`• “did not do any claim comparisons” (id. at 116:8);
`• had “not done any claim-by-claim analysis” (id. at 116:16-17);
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`2
`See Cardiocom, LLC v. Robert Bosch Healthcare Sys., Inc., No. IPR2013-
`00439 (P.T.A.B. Jan. 16, 2014), Paper 26 at 15-16 (“[W]e give little to no credit to
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`the analysis of Dr. Stone . . . . Dr. Stone does not cite evidence in the record for
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`his opinion . . . .”); Cardiocom, LLC v. Robert Bosch Healthcare Sys., Inc., No.
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`IPR2013-00460 (P.T.A.B. Jan. 16, 2014), Paper 23 at 13-14 (petitioner who relied
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`on a declaration by Dr. Stone did “not provide sufficient and credible evidence”).
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`4
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`Case IPR2015-00889
`U.S. Patent No. 8,573,209
`• was not provided any guidance on the relevant legal standards by
`Petitioner’s counsel, which he could not therefore apply (id. at
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`105:15-107:4);
`• failed to consider relevant, objective evidence of non-obviousness (id.
`at 64:7-65:6); and
`• based his analysis on impermissible hindsight bias using the ’209
`patent as the starting point for his analysis (id. at 60:24-61:2).
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`After Dr. Stone admitted to these critical deficiencies, Patent Owner filed its
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`response and timely objected to Dr. Stone’s testimony on December 9, 2015.
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`IV.
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`(Paper 30 at 19-32.)
` THE BOARD SHOULD EXCLUDE DR. STONE’S TESTIMONY
` Dr. Stone Failed to Analyze the Claims
`A.
`“It is a bedrock principle of patent law that the claims of a patent define the
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`invention . . . .” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005)
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`(internal quotation marks and citation omitted). By the same token, validity
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`(including obviousness) must be analyzed on a claim-by-claim basis. See, e.g.,
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`Dystar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356, 1372 (Fed. Cir.
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`2006) (“[W]e must evaluate obviousness on a claim-by-claim basis.”). As Judge
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`Rich put it, “the name of the game is the claim.” Judge Giles Sutherland Rich,
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`Extent of Protection and Interpretation of Claims—American Perspectives, 21
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`INT’L REV. INDUS. PROP. & COPYRIGHT L. 497, 499 (1990). For this reason, courts
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`have repeatedly rejected validity challenges that are not accompanied by
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`“testimony from one skilled in the art identifying each claim element and
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`explaining how each claim element is disclosed in the prior art reference.”
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`Creative Compounds, LLC v. Starmark Labs., 651 F.3d 1303, 1313 (Fed. Cir.
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`2011) (affirming summary judgment of no invalidity under 35 U.S.C. § 102(e)).
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`Dr. Stone’s declaration suggests that he did analyze the claims. (See, e.g.,
`Ex. 1002 ¶ 60 (“the architecture disclosed and claimed in the ’209 Patent does not
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`present any new concepts . . . .”).) However, under cross-examination, Dr. Stone
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`unequivocally admitted he did not analyze the claims:
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`Q. Did you do any analysis on a claim-by-claim basis?
`A. No, I did not.
`Q. Did you do, for any claims, an analysis on an element-by-element
`basis?
`A. No, I did not.
`(Ex. 2020 at 56:11-16.)
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`Q. So you can’t tell me, as you sit here today, what elements from the
`various claims of the five patents at issue are not present in the French
`’804 reference?
`A. I didn’t say I can’t. What I said is I have not done that analysis,
`and I would not do that.
`(Id. at 115:4-10.) This testimony reveals that Dr. Stone’s failure to perform the
`requisite analysis was no oversight; Dr. Stone actually refused to render opinions
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`comparing the prior art references to the patent claims at issue.
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`Instead of analyzing the claims, Dr. Stone admitted that he analyzed the ’209
`patent specification:
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`U.S. Patent No. 8,573,209
`Q. Okay. So when you’re trying to figure out what your combination
`is going to be, what was your target?
`A. The system and the things that the system did.
`Q. The system that’s described in the --
`A. In each of the patents.
`Q. -- specification?
`A. That’s correct.
`(Ex. 2020 at 104:16-24, 105:3-7 (“Q. Again, when you say “the system,” you’re
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`talking about the system that’s described in the specification of each of the five
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`patents you looked at? A. I believe that’s correct.”).)
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`Dr. Stone’s failure—or refusal, as the case may be—to analyze and opine on
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`the patent claims pervades every aspect of his opinions, rendering them unreliable,
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`irrelevant, and therefore inadmissible. Fed. R. Evid. 402 & 702. The obviousness
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`inquiry requires “a challenger [to] demonstrate by clear and convincing evidence
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`that a skilled artisan would have been motivated to combine the teachings of the
`prior art references to achieve the claimed invention, and that the skilled artisan
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`would have had a reasonable expectation of success in doing so.” ActiveVideo
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`Networks, Inc. v. Verizon Commc’ns, Inc., 694 F.3d 1312, 1327 (Fed. Cir. 2012)
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`(internal quotation marks and citation omitted).
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`But by Dr. Stone’s own admission, he did not even try to analyze the claims
`or understand what the claimed invention is. Dr. Stone’s admission that he did not
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`analyze the claims proves that he had no basis to opine that “the architecture
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`disclosed and claimed in the ’209 Patent does not present any new concepts not
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`disclosed in the prior art references . . . .” (Ex. 1002 ¶ 60.)
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`Dr. Stone’s opinions about something (whatever that is) other than the
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`claimed invention should be excluded as irrelevant. See Fed. R. Evid. 402
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`(“Irrelevant evidence is not admissible.”). Similarly, the Board should exclude his
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`opinions under Fed. R. of Evid. 702 because they are not based on “sufficient facts
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`or data,” they are not “the product of reliable principles and methods,” and Dr.
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`Stone has not “reliably applied the principles and methods to the facts of the case”
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`due to Dr. Stone’s failure and/or refusal to analyze the patent claims at issue. See
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`Fed. R. Evid. 702. Exclusion is also warranted in this case as a matter of policy to
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`dissuade petitioners from seeking to obtain review based on defective declarations
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`that cannot, as a procedural matter, be exposed until cross-examination. Indeed, in
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`light of Dr. Stone’s admissions at his deposition, the petition never should have
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`been instituted in the first place.
` Dr. Stone Failed to Apply Any Recognized Legal Standard
`Expert testimony that is premised on an incorrect legal standard cannot be
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`B.
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`relied upon to invalidate a patent:
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`InTouch argues that VGo’s expert testimony was replete with errors
`because Dr. Yanco applied an incorrect legal standard . . . . [W]e
`agree with InTouch that the evidence on which VGo relies is not
`substantial enough to support an obviousness finding. Indeed, it did
`not even come close. Dr. Yanco’s testimony was plagued with
`numerous problems . . . .
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`InTouch Techs., Inc. v. VGo Commc’ns, Inc., 751 F.3d 1327, 1348 (Fed. Cir.
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`2014). Despite Dr. Stone’s repeated references to legal terms and concepts in his
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`declaration, he admitted at his deposition that his application of legal concepts such
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`as obviousness and the motivation to combine in rendering his opinions was not
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`guided by any recognized legal standard:
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`Q. Okay. What do you understand “novelty” to mean?
`A. Novelty, I’m just - - ordinary meaning, it’s something that’s new.
`Q. . . . Okay. How does “obviousness” differ from “novelty”?
`A. Obviousness. “Obvious” means that a person of skill in the art
`would look at that and say “Yeah.” . . . I don’t know the legal
`terminology for it or describe it legally. I’d ask an attorney to
`describe it.
`(Ex. 2020 at 57:7-23.) The “standards” described above by Dr. Stone, if they can
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`even be called that, do not parallel those required of an appropriate analysis under
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`Section 103. Given Dr. Stone’s reliance on these “standards” in conducting his
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`analysis and rendering his opinions, the Board cannot properly rely on his
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`testimony. For example, Dr. Stone’s opinion that “[o]ne skilled in the relevant art
`would have found it obvious to use the sensor of the FR ’804 Publication . . . .”
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`(see Ex. 1002 ¶ 98) is completely irrelevant and unreliable because it is based on
`application of an unrecognized and incorrect standard.3
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`3
`Despite Dr. Stone’s testimony in his declaration using the word “obvious,”
`he claimed during his deposition that he did not opine on the legal issue of
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`obviousness. (Ex. 2020 at 105:11-14 (“Q. And I understand, as background of this
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`Dr. Stone’s opinions relating to motivation to combine are equally irrelevant
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`and unreliable (see, e.g., id. ¶ 115 “in my opinion, a person of skill in the art would
`be motivated to combine the ’510 Patent’s disclosure . . .”) because he failed to
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`apply any recognized legal standard:
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`Q. When you talk about this person of ordinary skill in the art being
`motivated to combine the references, do you mean motivated in the
`legal sense of motivated to combine them?
`A. No.
`(Id. at 61:25-62:4.) While it is unclear what Dr. Stone meant when he used the
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`phrase “motivated to combine” in his declaration, his deposition unambiguously
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`shows that he did not mean it in any sense that is relevant to this proceeding.
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`In addition, even if Dr. Stone had testified at his deposition that he was
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`endeavoring to provide opinions under the appropriate legal standard (which he did
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`not), there is no way he could have done so since Petitioner’s counsel did not
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`instruct him on, and he did not know, the appropriate legal standards:
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`Q. Did you get any information from your attorneys or from Praxair’s
`attorneys about what “obviousness” is in the patent context?
`A. I don’t believe we have discussed obviousness in the patent
`context.
`(Id. at 53:19-23.) The Board should exclude Dr. Stone’s testimony for this reason
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`as well. See Fed. R. Evid. 402 & 702; InTouch Techs., 751 F.3d at 1348-49.
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`line of inquiry, that you don’t -- you didn’t opine on the legal issue of obviousness.
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`Is that correct? A. That is correct.”).)
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`C.
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` Dr. Stone Improperly Used Hindsight Bias
`The Federal Circuit has consistently and repeatedly warned that “the trap of
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`hindsight” must be avoided in any obviousness analysis. See Mintz v. Dietz &
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`Watson, Inc., 679 F.3d 1372, 1378 (Fed. Cir. 2012) (citation omitted). “[A]voiding
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`subconscious reliance on hindsight” is a “difficult task.” Id. When an invention is
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`fully diagrammed and the court has the benefit of experts in the field, any
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`invention may seem “obvious,” but it in fact “may have been a breakthrough of
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`substantial dimension when first unveiled.” Id. (quoting Uniroyal, Inc. v. Rudkin–
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`Wiley Corp., 837 F.2d 1044, 1051 (Fed. Cir. 1988)).
`Here, far from trying to avoid the dangers of hindsight, Dr. Stone admitted
`that his analysis was in fact based on hindsight:
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`Q. And in this case, where you’re talking about the combinability of
`the concepts disclosed, did you start by looking at the patent and then
`figure out whether the art that your attorneys provided to you could be
`combined into what you saw in the patent?
`A. Don’t recall the detail of the discussion. We looked at what was
`in the patent. We looked at the prior art. Would a person do a similar
`thing? Yes. So that’s -- I think that’s the best way of describing it.
`Q. And I’m just trying to understand the order. But starting from
`looking at the patent itself; is that correct?
`A. Yes.
`(Ex. 2020 at 59:3-17; see also id. at 60:1-3.) Dr. Stone further confirmed that his
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`analysis did not begin with the prior art:
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`Q. . . . do you start with one reference and say, “Here’s a thing that
`we can modify using some of these other references to come up with
`the patented design,” or was your process something else?
`A. I think we looked at the overall system concept. “Are these things
`that one would put together in a gas delivery system and then,
`specifically, a nitric oxide system?” as opposed to, “Oh, there’s this
`seminal patent that we're going to improve upon.” I don’t recall doing
`it in that fashion at all.
`(Id. at 71:13-24); see also id. at 72:4-7 (“Q. Okay. Is it fair to say you didn’t start
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`with one of your references and add pieces from the other references to that first
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`reference? A. I don’t recall doing that.”).)
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`Dr. Stone further testified that his analysis was intended to show that,
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`working with the ’209 patent as a starting point, the prior art “could be combined
`into a system similar to the patented system.” (Id. at 71:10-11.) The Federal
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`Circuit has cautioned that “[d]efining the problem in terms of its solution reveals
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`improper hindsight in the selection of the prior art relevant to obviousness.” Insite
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`Vision Inc. v. Sandoz, Inc., 783 F.3d 853, 859 (Fed. Cir. 2015). That is precisely
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`what Dr. Stone did here, and the Federal Circuit has reversed obviousness findings
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`that relied on similarly defective testimony:
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`impermissible
`than
`testimony was nothing more
`Dr. Yanco’s
`hindsight; she opined that all of the elements of the claims disparately
`existed in the prior art, but failed to provide the glue to combine these
`references. While she opined that the references were like separate
`pieces of a simple jigsaw puzzle, she did not explain what reason or
`motivation one of ordinary skill in the art at the time of the invention
`would have had to place these pieces together. . . . It appears that Dr.
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`Yanco relied on the ’357 patent itself as her roadmap for putting what
`she referred to as pieces of a “jigsaw puzzle” together. . . . Dr.
`Yanco’s testimony primarily consisted of conclusory references to her
`belief that one of ordinary skill in the art could combine these
`references, not that they would have been motivated to do so.
`InTouch Techs., 751 F.3d at 1348-52 (emphasis original).
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`The Board has similarly found that expert testimony that is conclusory or
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`that only analyzes technical feasibility does not satisfy a petitioner’s burden:
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`The [expert] testimony explains why the cutting tool of Shapiro could
`be used to cut cancellous bone to form a cavity, but it does not
`provide a sufficient reason why it would have been obvious to so use
`it. The purported reason Dr. Harrigan provides is to avoid damage to
`nearby tissue outside of the bone. . . . However, one could also avoid
`such damage by not cutting anything. What the Petition lacks is a
`sufficient rationale for why, in the first instance, a person having
`ordinary skill would use the Shapiro cutting tool to cut a cavity in
`cancellous bone.
`Wright Med. Tech., Inc. v. Orthophoenix, LLC, No. IPR2014-00912 (P.T.A.B. Dec.
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`16, 2014), Paper 9 at 11-12 (emphasis original); see also, e.g., Panasonic Corp. v.
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`Optical Devices, LLC, No. IPR2014-00302 (P.T.A.B. July 11, 2014), Paper 9 at
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`14-15, 18-19 (denying institution and giving “little weight” to petitioner’s
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`“conclusory” expert declaration). Dr. Stone’s impermissible hindsight-driven
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`approach independently warrants the exclusion of his testimony.
` Dr. Stone Failed to Consider Objective Indicia of Nonobviousness
`Considering objective indicia of nonobviousness is a necessary element of
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`D.
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`any obviousness inquiry. InTouch Techs., 751 F.3d at 1347 (noting that a “district
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`court must consider evidence showing objective indicia of nonobviousness”).
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`Objective indicia may be considered as independent evidence of nonobviousness.
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`Id. These objective indicia are often “the most probative and cogent evidence of
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`nonobviousness” available. Id. They are, in fact, especially valuable as they help
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`protect against the threat of hindsight bias. Id.
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`Here, the failure of others to implement the claimed invention is a powerful
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`indicator of nonobviousness. Despite the existence of Petitioner’s cited prior art
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`and
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`the alleged obviousness of combining
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`the references, none of
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`the
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`contemporary providers of inhaled nitric oxide delivery devices included the
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`claimed features in their products (until Patent Owner released its embodying
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`products). This is highly relevant evidence in this case—both Petitioner and the
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`assignee of one of the patents which Dr. Stone relies on both made relatively
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`contemporaneous efforts to develop an inhaled nitric oxide delivery device, but
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`neither reached the claimed solution. (Paper 30 at 8-10, 58-59.) Dr. Stone should
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`have considered and addressed this evidence in reaching any relevant opinion, but
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`he failed to take it into account:
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`Q. Okay. Did you have any conversations with your counsel about
`objective indicia of non-obviousness?
`A. No.
`Q. . . . Okay. Did you consider them at all in connection with your
`analysis here?
`A. I did what I was asked to do, and that was not part of my
`analysis.
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`(Ex. 2020 at 134:20-135:4.) Indeed, Dr. Stone’s ignorance of this critical evidence
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`revealed that his analysis was based on an incorrect understanding of the law when
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`he asserted that such objective evidence was irrelevant. (See id. at 44:23-45:10.)
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`Here, Dr. Stone’s refusal to consider secondary considerations is remarkable
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`given that the relevant evidence of secondary considerations comes from one of the
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`very documents he submitted relating to the FR ’804 reference (Ex. 1011, Air
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`Liquide Opti Kinox Brochure) and the efforts of the Petitioner relating to its nitric
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`oxide delivery device.
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`Thus, Dr. Stone’s declaration should be excluded not just because he failed
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`to consider all of the relevant evidence, but because he refused to consider some of
`the most relevant evidence, asserting that it could have no effect on his
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`conclusions. See Fed. R. Evid. 402 & 702; InTouch Techs., 751 F.3d at 1348
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`(reversing obviousness finding that was based on expert testimony that failed to
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`V.
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`“consider any objective evidence of nonobviousness.”).
` CONCLUSION
`For the foregoing reasons, Patent Owner respectfully requests that Dr.
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`Stone’s testimony (Exhibits 1002 and 2020) be excluded under Federal Rules of
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`Respectfully submitted,
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`By: /Robert Steinberg/
`Robert Steinberg (Reg. No. 33,144)
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`Counsel for Patent Owner
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`15
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`Evidence 402 and 702.
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`Dated: April 11, 2016
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`Case IPR2015-00889
`U.S. Patent No. 8,573,209
`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 11th day of April,
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`2016, a true and correct copy of the foregoing Patent Owner’s Motion to
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`Exclude Evidence was served by electronic mail on Petitioner’s lead and backup
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`counsel at the following email addresses:
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`sanjay.murthy@morganlewis.com
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`mike.abernathy@morganlewis.com
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`maria.doukas@morganlewis.com
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`margaux.nair@klgates.com
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`benjamin.weed@klgates.com
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`Praxair-Ikaria@klgates.com
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`By: /Robert Steinberg/
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`Robert Steinberg (Reg. No. 33,144)
`bob.steinberg@lw.com
`Latham & Watkins LLP
`355 South Grand Avenue
`Los Angeles, CA 90071-1560
`213.485.1234; 213.891.8763 (Fax)