Trials@uspto.gov
`Tel: 571.272.7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_____________
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`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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`_____________
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`Case: IPR2015-00889
`Patent: 8,573,209 B2
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`_____________
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE EVIDENCE
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`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Tel: 571.272.7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_____________
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`PATENT TRIAL AND APPEAL BOARD
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`_____________
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`PRAXAIR DISTRIBUTION, INC.
`Petitioner
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`v.
`
`MALLINCKRODT HOSPITAL PRODUCTS IP LTD.,
`Patent Owner
`
`_____________
`
`
`Case: IPR2015-00889
`Patent: 8,573,209 B2
`
`_____________
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE EVIDENCE
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
`
`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
`
`I.
`
`INTRODUCTION
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`Praxair Distribution, Inc. (“Petitioner”) filed a petition for Inter Partes
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`review (“IPR”) to challenge the validity of U.S. Patent No. 8,573,209 (‘“209
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`Patent”) under 35 U.S.C. § 103. With its petition, Petitioner included Exhibit
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`1002, an expert declaration of Dr. Robert Stone. Dr. Stone is an expert in the field
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`of the alleged invention of the ‘209 Patent and the prior art references. On April
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`11, 2016, Patent Owner (“PO”) filed a Motion to Exclude Evidence (Paper 44)
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`seeking to exclude Exhibit 1002 and Exhibit 2020, Dr. Stone’s deposition
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`transcript, arguing that Dr. Stone did not perform a correct obviousness analysis (a
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`legal endeavor) and failed “to apply any recognized legal standards.” Paper 44 at
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`2. However, Dr. Stone is not required to perform any legal analysis; indeed, 37
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`C.F.R. § 42.65(a) and this Board’s precedent confirms that such testimony is
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`improper.
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`PO bases its Motion to Exclude Evidence on the assertion that “Dr. Stone
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`rendered [his] opinions without ever analyzing the claims of the ‘209 Patent.”
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`Paper 44 at 1-2 (emphasis in original). But PO’s fundamental premise is flawed.
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`Dr. Stone testified that he was “asked to review certain documents, including U.S.
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`Patent No. 8,573,209 (which I refer to as the ‘209 Patent) (Ex. 1001), and to
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`provide my opinions on what those documents disclose.” Ex. 1002 at ¶ 3; see also
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`Ex. 2020 at 104:1-3 (describing his review of the claims). He explained his task in
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`
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`1
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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`more detail during his deposition: “the claims put a box around what I was looking
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`at.” Ex. 2020 at 56:8-10; see also 105:1-2 (“Obviously, the claims put bounds on
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`it.”). During his deposition, Dr. Stone answered several questions about the scope
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`of the claims of the patents he opined about. See Ex. 2020 at 83:10-14 (“I believe
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`the claim is that it’s intermittent.”); 114:17-20 (“I believe some of the patents
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`claim particular types of nitric oxide therapies and levels.”). In sum, Dr. Stone did
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`review the claims, and offered opinions within the “box” or “bounds” defined by
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`the claims.
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`While Dr. Stone analyzed the subject matter of the claims, he did not
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`provide a “claim-by-claim analysis,” e.g. by providing a claim chart or other
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`breakdown of each claim in each patent. The fact that Dr. Stone did not do a
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`claim-by-claim analysis does not provide a basis for excluding his testimony. This
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`is a task within the Board’s purview.
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`PO’s Motion to Exclude should be denied for other reasons as well. First,
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`Dr. Stone provided proper expert testimony in his declaration in the form of a
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`scientific opinion. Second, he did not use improper hindsight reasoning in forming
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`his scientific opinion. Third, PO’s Motion to Exclude is procedurally flawed
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`because PO failed to preserve its objections pursuant to 37 C.F.R. § 42.64, a
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`prerequisite to filing a Motion to Exclude.
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`II. DR. STONE’S TESTIMONY IS PROPER EXPERT TESTIMONY
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`
`
`2
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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`Expert declarations are frequently useful, but are not required, to support
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`Final Written Decisions finding claims to be obvious. See, e.g., Valeo, Inc. v.
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`Magna Elec., Inc., Case Nos. IPR2014-00227 and IPR2014-00228, Paper 13 at 19
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`(May 29, 2014) (“expert testimony is not required in every case”); see also Black
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`Swamp IP, LLC v. VirnetX Inc., Case No. IPR2016-00167, Paper 12 at 4 (Feb. 4,
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`2016). As the Federal Circuit held in Wyers v. Master Lock Co., 616 F.3d 1231,
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`1240 (Fed. Cir. 2010), “KSR and our later cases establish that the legal
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`determination of obviousness may include recourse to logic, judgment, and
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`common sense, in lieu of expert testimony. See, e.g., Perfect Web, 587 F.3d at
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`1329; Ball Aerosol, 555 F.3d at 993.”
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`PO generally argues that Dr. Stone’s expert testimony should be excluded
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`because it does not contain a claim-by-claim analysis comparing prior art
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`disclosures to claim limitations. PO alleges that a claim-by-claim analysis is the
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`“requisite analysis” to be performed by an expert. Paper 44 at 6. But there is no
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`requirement that an IPR Petition be supported by expert testimony at all, and there
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`is no requirement that expert testimony, if submitted, must provide claim-by-claim
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`analysis as suggested by PO.1 Indeed, as explained below, there was no need to
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`
`1
`PO cites ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc. to support its
`
`argument that such a claim-by-claim expert opinion is required. Paper 44 at 7
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`
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`3
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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`provide such a claim-by-claim analysis here given the technology involved is not
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`complex and the prior art systems use the same terminology as the language in the
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`patent claims.
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`
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`
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`A. Dr. Stone Provided a Proper Scientific Opinion
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`In his declaration, Dr. Stone provided a proper scientific opinion on the
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`technical feasibility of combining certain aspects of the prior art. See Ex. 1002.
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`Before drafting his declaration, Dr. Stone reviewed the ‘209 Patent as well as prior
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`art references including U.S. Patent No. 7,114,510 (“‘510 Patent”), U.S. Patent No.
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`5,558,083 (“‘083 Patent”), English-language
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`translation of French Patent
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`Publications No. 2 917 804 (“FR ‘804 Publication”), and ISO/IEEE 11073-30300
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`“Health informatics -- Point-of-care medical device communication -- Part 30300:
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`Transport profile -- Infrared wireless” (“IR Standard”). In his declaration, Dr.
`
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`(citing 694 F.3d 1312, 1327 (Fed. Cir. 2012)). ActiveVideo Networks is an appeal
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`from a District Court judgment, where the evidentiary standard is clear and
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`convincing evidence, and not preponderance of the evidence as is the case here.
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`Id.; see also 37 C.F.R. § 42.1(d). Moreover, to the extent this case is relevant,
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`nothing in the cited case requires that claim-by-claim expert testimony is required
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`even under the more stringent district court evidentiary standard. ActiveVideo
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`Networks, Inc., 694 F.3d at 1327.
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`
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`4
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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`Stone provided a reasoned, technology-based scientific opinion on the technical
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`aspects of the prior art references and on the combinability of the concepts
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`disclosed in the references from a technical perspective. Specifically, Dr. Stone
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`explained why a person of skill in the art would be motivated to combine the prior
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`art references. (See generally Ex. 1002 at ¶¶ 92-121). This technical analysis is
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`precisely the type of analysis of the prior art references and why a person of skill in
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`the art would have known to combine the prior art references contemplated by
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`Rule 702 of the Federal Rules of Evidence.
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`
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`The ‘209 Patent incorporates the PO’s own prior art by reference as enabling
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`disclosure for the claim limitations that correspond to each reference. Ex. 1001 at
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`7:26-28 (‘510 Patent), 9:50-52 (‘083 Patent). Unsurprisingly, the claims of the
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`‘209 Patent use language nearly identical to that of the incorporated-by-reference
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`prior art. Compare, e.g., Ex. 1001 at 16:24-27 with Ex. 1004 at 2:43-51. The
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`Board simply does not need an expert opinion comparing claim limitations to
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`nearly identical language in the prior art.
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`
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`Instead, Dr. Stone testified that “a person of skill in the art could have
`
`combined the gas delivery system of the ‘083 Patent with the ‘510 Patent, the FR
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`‘804 Publication, and the IR Standard to result in an improved gas delivery system
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`possessing the benefits of each reference.” Ex. 1002 at ¶ 121. As the Board’s
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`decision to institute trial (Paper 14) preliminarily found, the features of this system
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`
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`5
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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`are identical to the features described in the ‘209 Patent, so Dr. Stone’s testimony
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`is unquestionably relevant and is thus admissible under Rule 402 of the Federal
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`Rules of Evidence.
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`B.
`
`The Role of an Expert is to Provide a Scientific, Not Legal,
`Opinion
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`
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`PO asserts that Dr. Stone’s testimony should be excluded because he did not
`
`apply the correct legal standards in his analysis. Paper 44 at 9-10. But the plain
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`language of the Federal Rules of Evidence belies this notion. According to Rule
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`702 of the Federal Rules of Evidence, an expert witness may testify in the form of
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`an opinion if “(a) the expert’s scientific, technical, or other specialized knowledge
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`will help the trier of fact to understand the evidence or to determine a fact in
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`issue.” PO has no credible argument to undermine the conclusion that Dr. Stone’s
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`testimony will help the trier of fact to understand the evidence or to determine a
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`fact in issue.
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`
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`The rules do not require Dr. Stone to offer opinions on legal standards or
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`purely legal matters (such as the ultimate conclusion of obviousness); indeed, the
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`rules specifically applicable to this proceeding prohibit Dr. Stone from doing so.
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`Expert testimony in an Inter Partes Review is governed by 37 C.F.R. 42.65, which
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`states that testimony regarding U.S. patent law is not permitted. 37 C.F.R. §
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`
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`6
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`U.S. Patent No. 8,573,209
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`42.65(a). Dr. Stone did not opine on legal issues because he is not permitted to
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`make any legal analyses or conclusions about United States patent law.
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`
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`Nor would opinions on legal concepts have been helpful. Both the Board
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`and the Federal Circuit have held that legal conclusions by experts are “neither
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`necessary nor controlling.” See Nichia Corp. v. Emcore Corp., Case No. IPR2012-
`
`00005, Paper 68 at 59 (“We recognize that expert testimony on the ultimate ‘legal
`
`conclusion of obviousness is neither necessary nor controlling.’”)(citing Avia Grp.
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`Int’l, Inc. v. L.A. Gear Cal., Inc., 853 F.2d 1557, 1564 (Fed. Cir. 1988)); see also
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`Nutrition 21 v. United States, 930 F.2d 867, 871 n.2 (Fed. Cir. 1991)(“An expert’s
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`opinion on the ultimate legal conclusion is neither required nor indeed ‘evidence’
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`at all.”) (citing Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 767 (Fed. Cir.
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`1988)).
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`
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`Further, the Board has held that whether an expert understands legal
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`standards is not a ground to exclude evidence or testimony. See SK Innovation
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`Co., Ltd., v. Celgard, LLC Case No. IPR2014-00679, Paper 58 at 53 (denying a
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`motion to exclude expert testimony stating “we are not persuaded, moreover, that
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`any potential deficiencies in Dr. Arnold’s understanding of the legal concepts of
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`unpatentability warrant excluding his testimony entirely.”). For the same reasons,
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`Dr. Stone’s testimony should be excluded.
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`
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`7
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`U.S. Patent No. 8,573,209
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`
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`Finally, PO’s Motion to Exclude reflects purely a form-over-substance
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`position. PO’s motion does not identify any problems caused by Dr. Stone’s
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`failure to provide a treatise on obviousness law. PO does not argue that this failure
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`undermines Dr. Stone’s conclusions. Instead, PO seeks a blanket exclusion of
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`evidence without actual regard for whether the evidence is proper under the
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`Federal Rules of Evidence.2
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`
`
`C. Dr. Stone Did Not Use Improper Hindsight
`
`
`2
`PO argues that Dr. Stone did not consider secondary considerations of non-
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`obviousness. Paper 44 at 13-15. PO’s argument ignores the fact that Dr. Stone’s
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`declaration was submitted with the Petition and therefore he could not have
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`considered PO’s supposed evidence of secondary considerations that were cited
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`nine months later. Moreover, there was no reason for Dr. Stone to consider this
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`evidence in any rebuttal declaration. As explained in Petitioner’s Reply (Paper
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`40), PO has not shown any nexus as would be required for its evidence to support a
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`finding of non-obviousness, and there are many regulatory, commercial, or
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`logistical reasons aside from non-obviousness that highly-regulated medical
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`devices from different countries and different suppliers may or may not have
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`contained certain features. Paper 40 at 17.
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`
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`8
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`U.S. Patent No. 8,573,209
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`
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`PO argues that Dr. Stone relied on improper hindsight in arriving at his
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`opinions. Paper 44 at 11-13. While the specification and claims of the ‘209 Patent
`
`certainly defined the metes and bounds of the subject matter about which Dr. Stone
`
`opined (see Ex. 1002 at ¶ 3; Ex. 2020 at 56:8-10, 105:1-2), PO cites to no case law
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`that states a claim-by-claim analysis is required to define those bounds. Instead,
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`the use of such a document to set forth the subject matter at issue (in this case,
`
`therapeutic gas/nitric oxide delivery systems) is the very fact that shows the
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`testimony is relevant and thus admissible under Rule 402 of the Federal Rules of
`
`Evidence.
`
`
`
`The testimony PO cites with regard to how Dr. Stone constructed his opinion
`
`also undermines its own position. Paper 44 at 12. In the cited testimony, Dr.
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`Stone was not explaining that he used hindsight to perform his invalidity analysis
`
`for the ‘209 Patent, but rather that in his mind, the prior art references he
`
`considered did not contain a clear “primary” reference and a handful of minor
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`“secondary” references. Ex. 2020 at 71:25-72:1 (“Q. Okay. So is it fair to say,
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`then, that you didn't have a primary reference? A. I have not discussed the concept
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`of a, quote, primary reference.”).
`
`
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`Finally, contrary to the cited reasoning in InTouch Techs., Inc. v. Vgo
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`Commc’ns, Inc., Dr. Stone, here, spent substantial time in both his declaration and
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`
`
`9
`
`
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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`his deposition explaining “the glue to combine these references.” 751 F.3d 1327,
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`1348-52 (Fed. Cir. 2014); see, e.g., Ex. 1002 at ¶ 96; Ex. 2020 at 11:22-12:18.
`
`
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`Dr. Stone explained that it is the FR ‘804 Publication itself, not the teaching
`
`of the ‘209 Patent, that provides the reason and the mechanism to have the delivery
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`system described in the ‘083 Patent communicate with the valve described in the
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`‘510 Patent. See, e.g., Ex. 2020 at 112:14-18 (“what it utilized [in the challenged
`
`patent] is a technique that's very similar to the French patent, the ‘804, where the
`
`information about the gas is delivered to a computerized gas delivery system.”);
`
`see also 82:19-25, 113:18-22, 130:15-18, 135:13-17. Thus, the technical analysis
`
`by Dr. Stone is not an improper use of hindsight. Rather, the record here clearly
`
`establishes that Dr. Stone’s testimony is relevant, proper expert testimony and
`
`should not be excluded.
`
`III. PATENT OWNER’S MOTION TO EXCLUDE IS PROCEDURALLY
`DEFICIENT
`
`
`
`
`
`A.
`
`Patent Owner Did Not Follow The Board’s Rules and Thus Did
`Not Preserve Its Evidentiary Objections
`
`PO’s Motion to Exclude should also be denied because it failed to follow the
`
`Board’s rules with regard to excluding evidence. 37 C.F.R. 42.64(b)(1) states that
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`a patent owner must make any objection to evidence submitted with the petition by
`
`filing such objections within 10 business days of the institution of trial. The Board
`
`instituted trial in this proceeding on September 22, 2015. Paper 14. Thus, PO was
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`10
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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`required to file any objections to evidence by October 6, 2015. PO did not file any
`
`objections to evidence submitted with the petition, and based on the rules has
`
`waived such objections.3
`
`
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`Now, more than six months after institution of trial, PO raises an evidentiary
`
`objection to Dr. Stone’s declaration. PO recognizes that it did not follow the
`
`proper evidentiary procedures, as is clear from its reliance on the Patent Owner
`
`Response (Paper 30) as the alleged support required by 37 C.F.R. § 42.64. Paper
`
`44 at 2. Yet, even in the 12 pages of its Patent Owner Response identified in the
`
`Motion to Exclude, PO never used the word “object” and certainly did not provide
`
`“the grounds for the objection with sufficient particularity to allow correction in
`
`the form of supplemental evidence.” 37 C.F.R. § 42.64(b)(1). Nowhere in the
`
`body of the Patent Owner Response did PO cite to 37 C.F.R. §§ 42.64 or 42.65,
`
`mention the Federal Rules of Evidence, or aver that Dr. Stone’s testimony is
`
`“irrelevant and unreliable” as it now asserts. Paper 44 at 3. PO’s failure to follow
`
`
`3
`On May 19, 2015, more than four months before the Board instituted trial in
`
`this proceeding, the United States Patent and Trademark Office amended the “first
`
`and second sentences of 37 CFR 42.64(b)(1) to replace ‘served’ with ‘filed’ so as
`
`to require filing of objections, which also requires service under 37 CFR
`
`42.6(e)(2).” 80 Fed. Reg. 28561, 28563 (May 19, 2015).
`
`
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`11
`
`
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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`the Board’s rules is unquestionably a waiver of its ability to file a Motion to
`
`Exclude, as the very rule PO relies on states that “[a]ny objection to evidence
`
`submitted during a preliminary proceeding must be filed within ten business days
`
`of the institution of the trial.” 37 C.F.R. § 42.64(b)(1).
`
`B. Dr. Stone’s Declaration Clearly Defined His Opinions
`
`To cope with its failure to follow the Board’s rules, PO contends that it “had
`
`not deposed Dr. Stone at the time the Decision issued, and neither the Board nor
`
`Patent Owner had any way of knowing what Dr. Stone would later admit at his
`
`deposition. Paper 44 at 4. This argument is disingenuous; the scope of Dr. Stone’s
`
`opinions was apparent from his declaration (Ex. 1002) in this proceeding. 4
`
`Dr. Stone opined that “I am not offering opinions on ultimate issues of
`
`validity or claim construction. I am simply providing my opinion on the technical
`
`aspects of the documents and on the combinability of the concepts disclosed in
`
`those documents from a technical perspective.” Ex. 1002 at ¶ 7. He did not
`
`include claim charts in his opinion, nor did he include claim-by-claim analysis of
`
`any challenged claims. PO contends that Dr. Stone made “repeated references to
`
`
`4 Moreover, pursuant to the rules of practice in front of the Board, the scope
`
`of the deposition is limited to the scope of the declaration. See, e.g. 37 C.F.R. §
`
`42.53 (d)(2).
`
`
`
`12
`
`
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`U.S. Patent No. 8,573,209
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`legal terms and concepts in his declaration.” Paper 44 at 9. Review of Dr. Stone’s
`
`declaration, however, shows that not to be the case. The Board’s decision to
`
`institute in view of Dr. Stone’s opinions (and indeed to cite to Dr. Stone’s opinions
`
`for a handful of propositions, see Paper 14 at 16, 17, 19, 20, 21) shows the
`
`propriety of those opinions, and shows that Dr. Stone’s analysis is probative and
`
`relevant to the ultimate legal determinations the Board will make in this
`
`proceeding.
`
`C.
`
`Patent Owner Cannot Exclude an Exhibit Patent Owner Itself
`Submitted More Than Three Months Ago
`
`
`
`PO seeks to exclude Exhibit 2020, which is the transcript of the deposition
`
`PO conducted of Dr. Stone based on Dr. Stone’s declaration in support of the
`
`petition. PO asks this Board to exclude an exhibit that PO itself filed – the rules
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`simply do not provide for this tactic. PO’s request to exclude Exhibit 2020 is
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`nothing but another indication that its Motion to Exclude is, as a whole, a last-
`
`ditch, untimely effort to save its patent claims by ignoring the Board’s evidentiary
`
`rules. PO evidently did not realize the dire straits its patent claims were in when it
`
`filed the Patent Owner Reponses (and voluntarily filed Exhibit 2020 thereto). It
`
`cannot now seek to avoid obviousness by asking the Board to exclude an exhibit
`
`that contains testimony for which PO has no response.5
`
`
`5
`Had PO elected not to file Exhibit 2020 when it filed its Patent Owner
`
`
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`13
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`U.S. Patent No. 8,573,209
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`IV. CONCLUSION
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`
`
`For the foregoing reasons, Petitioner respectfully requests the PO’s Motion
`
`to Exclude Evidence be denied.
`
`Date: April 25, 2016
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`
`
`
`Respectfully submitted:
`
`By:
`
`
`
`/Sanjay K. Murthy/
`Sanjay K. Murthy
`Reg. No. 45,976
`
`
`
`
`
`
`
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`Response, the posture of the case would have been such that Petitioner could have
`
`submitted Dr. Stone’s deposition transcript had it desired to do so. PO’s attempt to
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`re-shape the evidentiary record at the end of the trial is substantially prejudicial to
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`Petitioner, whose Reply and decisions with regard to Motions to Exclude have
`
`been made on the evidentiary record as it existed when PO submitted the Patent
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`Owner Response.
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`
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`14
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`
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`Certification of Service Under 37 C.F.R. § 42.6(e)(4)
`
`A copy of this Opposition to Patent Owner’s Motion to Exclude Evidence
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`has been served on the following counsel of record for Patent Owner by electronic
`
`mail to the following e-mail addresses on April 25, 2016:
`
`Robert Steinberg (Reg. No. 33,144)
`bob.steinberg@lw.com
`
`Daniel G. Brown (Reg. No. 54,005)
`daniel.brown@lw.com
`
`David K. Callahan (pro hac vice)
`david.callahan@lw.com
`
`Kenneth G. Schuler (pro hac vice)
`kenneth.schuler@lw.com
`
`Marc N. Zubick (pro hac vice)
`marc.zubick@lw.com
`
`
`
`
`
`
`/Sanjay K. Murthy/
`Reg. No. 45,976
`Morgan, Lewis & Bockius LLP
`77 West Wacker Drive, Fifth Floor
`Chicago, IL 60601
`sanjay.murthy@morganlewis.com
`T: (312) 324-1448
`F: (312) 324-1001
`
`
`
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