Filed on behalf of: Mallinckrodt Hosp. Prods. IP Ltd.
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`Entered: May 2, 2016
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`PRAXAIR DISTRIBUTION, INC.,
`Petitioner
`
`v.
`
`MALLINCKRODT HOSPITAL PRODUCTS IP LTD.,
`Patent Owner
`_______________________
`
`Case IPR2015-00884
`U.S. Patent No. 8,291,904 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 REPLY TO PETITIONER’S OPPOSITION
`TO PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
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`
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`
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`Entered: May 2, 2016
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`PRAXAIR DISTRIBUTION, INC.,
`Petitioner
`
`v.
`
`MALLINCKRODT HOSPITAL PRODUCTS IP LTD.,
`Patent Owner
`_______________________
`
`Case IPR2015-00884
`U.S. Patent No. 8,291,904 B2
`_______________________
`
`Before KEN B. BARRETT, MICHAEL J. FITZPATRICK, AND
`SCOTT A. DANIELS, Administrative Patent Judges.
`
`
`
`PATENT OWNER’S REPLY TO PETITIONER’S OPPOSITION
`TO PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`
`
`
`
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`
`
`Case IPR2015-00884
`U.S. Patent No. 8,291,904
`I.
`AN EXPERT’S TECHNICAL ANALYSIS CANNOT BE ENTIRELY
`UNTETHERED FROM THE RELEVANT LAW
`Petitioner argues that the Dr. Robert Stone’s expert declaration (Ex. 1002)
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`was proper because he performed a technical, not legal analysis. Petitioner’s
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`argument misses the point; Patent Owner argues that the Board should strike Dr.
`Stone’s technical opinions because they are demonstrably untethered to any legal
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`principles, and in many instances, contradict the relevant laws.
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`A. Dr. Stone’s Method of Analysis Contained Multiple Errors
`“[T]he claims of a patent define the invention . . . .” Phillips v. AWH Corp.,
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`415 F.3d 1303, 1312 (Fed. Cir. 2005) (internal quotation marks and citation
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`omitted). As the Board noted recently “it is not enough to show merely that the
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`prior art includes separate references covering each separate limitation in a
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`challenged claim.” Costco Wholesale Corp. v. Robert Bosch LLC, Case No.
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`IPR2016-00035, Paper 16 at 23 (April 25, 2016). Instead, obviousness requires
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`showing that a person of ordinary skill in the art “would have selected and
`combined those prior art elements . . . to yield the claimed invention.” Id. (citing
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007)).1 “It is elementary that
`the claimed invention must be considered as a whole in deciding the question of
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`obviousness.” Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
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`164 (Fed. Cir. 1985) (emphasis in original).
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`Petitioner asserts that because Dr. Stone reviewed the claims and “the claims
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`1 All emphases added unless otherwise noted.
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`1
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`Case IPR2015-00884
`U.S. Patent No. 8,291,904
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`put a box around what [he] was looking at,” he did not need to perform a claim by
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`claim analysis. (Paper 48, Petitioner’s Opposition to Motion at 1-2.) A passing
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`review of the claims is insufficient where the relevant inquiry is whether “the
`subject matter sought to be patented . . . as a whole would have been obvious” to a
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`person of skill in the art. Costco Wholesale, IPR2016-00035, Paper 16 at 24-25
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`(quoting 35 U.S.C. § 103(a)). Petitioner admits that Dr. Stone did no such
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`analysis. (See Paper 48 at 2 (“The fact that Dr. Stone did not do a claim-by-claim
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`analysis . . . .”).)
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`An obviousness determination also requires analysis of “any differences
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`between the claimed subject matter and the prior art . . . .” Costco Wholesale,
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`IPR2016-00035, Paper 16 at 13-14 (citing Graham v. John Deere Co., 383 U.S. 1,
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`17–18 (1966)). In making this determination, the question “is not whether the
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`differences themselves would have been obvious, but whether the claimed
`invention as a whole would have been obvious.” Id. at 14 (citing Litton, 755 F.2d
`at 164). Dr. Stone failed to conduct this portion of the Deere test.
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`Dr. Stone also relied on impermissible hindsight in forming his opinions. A
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`factfinder must be wary “of the distortion caused by hindsight bias and must be
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`cautious of arguments reliant upon ex post reasoning.” Id. at 15 (quoting KSR, 550
`U.S. at 421). Dr. Stone admitted that his analysis was based only on hindsight: “If
`I were attempting to solve something that's claimed here, would I do that? And the
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`answer is yes.” (Ex. 2020, Deposition of Dr. Stone, 60:1-3.) Petitioner’s only
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`argument in response is that Dr. Stone did not start with a primary reference (Paper
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`48 at 9), which is irrelevant to his admission that he started with the solution and
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`2
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`Case IPR2015-00884
`U.S. Patent No. 8,291,904
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`worked backwards. (Ex. 2020 at 60:18-22 (“To someone looking at that, would
`they say, ‘Yeah, I would do that.’ Could I do that? Is there anything challenging to
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`accomplishing that? Yes, I did that analysis in that form.”).)
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`Dr. Stone may have avoided falling into the hindsight trap if he had
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`considered the objective evidence of nonobviousness; because Petitioner failed to
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`instruct him on the nature and import of such evidence, he was unable to do so.
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`See InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1347 (Fed. Cir.
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`2014) (“Objective indicia may often be the most probative and cogent evidence of
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`nonobviousness in the record.”) (internal quotations marks omitted).
`B.
`Petitioner correctly states that Dr. Stone is not required to opine on “legal
`
`Petitioner’s Cited Case Law Does Not Support Its Position
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`standards or purely legal matters.” (Paper 48 at 6.) Dr. Stone was not free,
`however, to ignore legal requirements, e.g., avoiding hindsight analysis, that must
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`cabin the analysis. Dr. Stone thinks that “‘Obvious’ means that a person of skill in
`
`the art would look at that and say ‘Yeah.’” (Ex. 2020 at 57:16-18.) He may not
`opine contrary to established law.
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`Petitioner cites to a Board decision for the uncontroversial statement that
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`“expert testimony is not required in every case.” (Paper 48 at 3 (citing Valeo, Inc.
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`v. Magna Elec., Inc., Case Nos. IPR2014-00227 and IPR2014-00228, Paper 13 at
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`19 (May 29, 2014) (“[E]xpert testimony is not required in every case”).) However,
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`this statement was in reference to an anticipation claim; the obviousness grounds in
`that case were supported by an expert declaration. See Valeo, IPR2014-00227,
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`Paper 13 at 13, 35-37. The other case Petitioner cites, Black Swamp IP, LLC v.
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`3
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`Case IPR2015-00884
`U.S. Patent No. 8,291,904
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`VirnetX Inc., Case No. IPR2016-00167, Paper 12 at 4 (Feb. 4, 2016), was primarily
`a decision to allow joinder to a previously instituted proceeding, which was
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`supported by an expert declaration and thus procedurally inapposite. See id. at 3.
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`Petitioner also cites SK Innovation Co., v. Celgard, LLC, Case No. IPR2014-
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`00679, Paper 58 at 53 (Sept. 25, 2015), to argue: “whether an expert understands
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`legal standards is not a ground to exclude evidence or testimony.” (Paper 48 at 7.)
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`Petitioner overstates the Board’s decision, as shown by the very testimony quoted
`by Petitioner: “we are not persuaded, moreover, that any potential deficiencies in
`Dr. Arnold’s understanding of the legal concepts of unpatentability warrant
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`excluding his testimony entirely.” (Paper 48 at 7.) At best, the holding was that
`the Board was not required to exclude on those grounds, not that it could not
`exclude where (as here) the analysis was contrary to the law.
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`II. DR. STONE HAD THE OPPORTUNITY, BUT FAILED TO
`CONSIDER EVIDENCE OF SECONDARY CONSIDERATIONS
`Petitioner claims that Dr. Stone “could not have considered” the evidence
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`that others did not find the patented safety feature obvious. (Paper 48 at 8 n.2.)
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`Petitioner’s arguments are demonstrably false. First, the NOMIX device was
`Petitioner’s own inhaled nitric oxide device previously in use in Mexico. Second,
`Dr. Stone could have considered the OptiKINOX as he cited it in his declaration.
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`(Ex. 1002, Declaration of Dr. Stone, ¶ 63.) Third, Dr. Stone was aware of his own
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`work on inhaled nitric oxide devices. The problem was not access, but
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`understanding the relevance to the obviousness analysis.
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`4
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`Case IPR2015-00884
`U.S. Patent No. 8,291,904
`III. PATENT OWNER HAS COMPLIED WITH ALL REQUIREMENTS
`Lacking a substantive argument, Petitioner raises several procedural
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`arguments that are without merit. First, Petitioner alleges that Patent Owner failed
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`to object to Dr. Stone’s declaration “within 10 business days of the institution of
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`trial.” (Paper 48 at 10.) However, the serious defects in the bases for Dr. Stone’s
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`analysis were not apparent until Dr. Stone’s deposition, and Patent Owner timely
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`objected in its Patent Owner’s Response. (See, e.g., Paper 30 at 23 (“A third fatal
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`flaw with regard to Dr. Stone’s proffered testimony is that it ignores an entire and
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`significant portion of the obviousness inquiry—objective indicia . . . .”).)
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`Petitioner had a full opportunity to respond to Patent Owner’s objections.
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`Patent Owner’s Response detailed at least four distinct objections to Dr. Stone’s
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`testimony in four separate subsections. Petitioner could have addressed these
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`objections by submitting additional evidence. Dr. Stone could have provided a
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`supplemental declaration, or Petitioner could have provided supplemental
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`evidence. Indeed, recognizing the strength of Patent Owner’s arguments,
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`Petitioner did provide new evidence with its Reply. (Exs. 1021-24.)
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`Finally, Patent Owner does not seek to exclude Dr. Stone’s deposition
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`testimony. Rather, Patent Owner’s motion sought to exclude “Dr. Stone’s
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`opinions . . . as irrelevant and unreliable.” (Paper 44 at 2.) Patent Owner cites to
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`and references Dr. Stone’s deposition testimony only to demonstrate why the
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`opinions in Dr. Stone’s declaration should be excluded.
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`Dated: May 2, 2016
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`Respectfully submitted,
`By: /Robert Steinberg/
`Robert Steinberg (Reg. No. 33,144)
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`5
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`Case IPR2015-00884
`U.S. Patent No. 8,291,904
`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 2nd day of May,
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`2016, a true and correct copy of the foregoing Patent Owner’s Reply to
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`Petitioner’s Opposition to Patent Owner’s Motion to Exclude Evidence was
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`served by electronic mail on Petitioner’s lead and backup counsel at the following
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`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)
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