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`IPR2016-01370
`U.S. Patent No. 8,664,231
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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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`KOIOS PHARMACEUTICALS LLC,
`Petitioner
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`v.
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`MEDAC GESELLSCHAFT FUER KLINISCHE
`SPEZIALPRÄPARATE MBH,
`Patent Owner
`____________
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`Case No. IPR2016-01370
`Patent Number 8,664,231
`____________
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`Before JACQUELINE WRIGHT BONILLA, TONI R. SCHEINER,
`and ERICA A. FRANKLIN, Administrative Patent Judges
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`PATENT OWNER’S REPLY IN SUPPORT
`OF ITS MOTION TO EXCLUDE EVIDENCE
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`Patent Owner medac Gesellschaft für Klinische Spezialpräparate mbH
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`(“Medac”) replies to Petitioner’s Response to Medac’s Motion to Exclude
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`Evidence (“Resp.”). 37 C.F.R. §§ 42.23 and 42.64.
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`I.
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`Exhibits 1041-1046 Should be Excluded
`The Board should exclude Exhibits 1041-46. They are
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`irrelevant,
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`inadmissible hearsay, and/or improperly authenticated.
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`A. Exhibit 1041 Should be Excluded
`Exhibit 1041 is an e-mail exchange between counsel. It is far from an
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`“invitation” to take depositions (Resp. at 1). It is a notice that only a single day
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`and a single place was available for each of the possible depositions.
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`Petitioner’s assertion that Exhibit 1041 is not offered as evidence of why
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`Medac “refused” to take depositions (id.) contradicts its reliance on the Exhibit to
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`argue that Medac “refused” to depose its experts due to the “quality” of their
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`opinions. Petitioner’s Response at 1, 3, 20. And, if Petitioner is not offering
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`Exhibit 1041 for that purpose (as it claims), then it is simply irrelevant.
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`Petitioner’s “inference” argument, likewise, does not carry the day. Resp. at 1.
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`There are many reasons for not deposing an expert aside from the alleged “quality”
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`of any opinion. Given Petitioner’s misleading statements about Exhibit 1041, and
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`its lack of relevance to any substantive issue, it should be excluded. F.R.E. 402,
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`403.
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`B.
`Exhibit 1042 Should be Excluded
`Exhibit 1042 purports to be a UK High Court decision regarding a UK
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`patent. It is not self-authenticating (Resp. at 2). It is a website printout and is not
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`signed or attested to by an authorized person nor accompanied by the required
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`certification. F.R.E. 902(3). Petitioner has also not provided any other
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`authentication. F.R.E. 901(a).
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`Exhibit 1042 is also irrelevant. Despite any alleged similarity between the
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`claims said to be before the High Court and the claims in this IPR (Resp. at 2), the
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`two proceedings involve different claims, different legal standards and different
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`art. Notwithstanding these critical differences, Petitioner improperly invites the
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`Board to compare the claims of both patents and to infer that the UK decision
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`somehow applies here. Id. Petitioner also asserts that the obviousness decision in
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`Exhibit 1042 is somehow relevant to Medac’s novelty argument. Id. This is
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`contrary to U.S. patent law. 35 U.S.C. § 102.
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`Finally, Petitioner admits that it is relying on Exhibit 1042 for “the truth of
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`what those decisions concluded” (Resp. at 2), but has not pointed any hearsay
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`exception. F.R.E. 803. Indeed, judicial decisions generally are inadmissible for
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`their findings. See, e.g., Nipper v. Snipes, 7 F.3d 415, 417 (4th Cir. 1993).
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`For all of these reasons, Exhibit 1042 should be excluded. F.R.E. 401-403,
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`802 and 901-902.
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`C. Exhibits 1043 and 1046 Should be Excluded
`Exhibit 1043 purports to be a copy of an online third-party news summary of
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`a non-U.S. court decision regarding a Netherlands patent. In response to Medac’s
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`original objection, Petitioner served and filed Exhibit 1046, which purports to be
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`that non-U.S. court decision.
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`Medac objects to Exhibit 1046. It is not self-authenticating because it is
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`neither signed or attested to nor accompanied by a certification. F.R.E. 902(3).
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`Petitioner also has not provided any other authentication. F.R.E. 901(a). Exhibit
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`1046 is also in a foreign language, and Petitioner has not submitted the required
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`translation and attestation affidavit. 37 C.F.R. § 42.63(b). For both reasons,
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`Exhibits 1043 and 1046 should be excluded.
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`Exhibits 1043 and 1046 are also irrelevant. F.R.E. 401, 402, and 403. The
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`decision in Exhibit 1046 (summarized in Exhibit 1043) involved different claims,
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`different legal standards, and different art than those at issue here. Petitioner also
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`incorrectly asserts that the inventive step decision in Exhibit 1046 is relevant to
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`Medac’s novelty argument. Resp. at 3. This is contrary to U.S. patent law. 35
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`U.S.C. § 102.
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`Exhibits 1043 and 1046 should also be excluded as impermissible hearsay
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`because Petitioner has offered the decision for the truth of the matters asserted.
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`F.R.E. 802. Petitioner, however, has not pointed to any hearsay exception that
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`applies to either Exhibit 1043 or 1046. F.R.E. 803. See also, Nipper, 7 F.3d at 417.
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`D. Exhibits 1044 and 1045 Should be Excluded
`Exhibits 1044 and 1045 are portions of the file history of an application that
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`claims benefit of the application that issued as the ’231 patent. Petitioner implies
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`that the PTO’s non-final rejection (Exhibit 1044), and applicant’s abandonment
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`(Exhibit 1045), indicate that the claims in this IPR are invalid. Resp. at 4.
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`Moreover, Petitioner uses Exhibit 1045 improperly to contend that Medac “had no
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`response” to the rejection (Reply at 1). Neither is correct. Medac has continued to
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`prosecute
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`the very same claims
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`in continuation application 15/592,882.
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`Accordingly, Petitioner’s reliance on Exhibit 1045 is misleading, inaccurate, and
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`unfairly prejudicial. Weight versus admissibility (Resp. at 4) does not cure those
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`problems.
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`Both exhibits are also irrelevant. F.R.E. 401, 402, and 403. The non-final
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`obviousness rejection involves different claims and relies on art that is not in this
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`IPR. See Ex. 1044 at 4, 6, 7, 9, 10. Exhibit 1044, therefore, does not make it any
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`more or less likely that the challenged claims in this IPR are unpatentable.
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`II.
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`Improper Testimony Elicited from Ms. Shoemaker Should be Excluded
`The Board should exclude the objected-to testimony of Ms. Shoemaker. It is
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`outside the permissible scope of cross-examination. 37 C.F.R. § 42.53(d)(5)(ii).
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`Ms. Shoemaker’s declaration addressed only a prior consulting relationship
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`4
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`between Medac and Petitioner’s expert Dr. Schiff. Ex. 2011. Petitioner’s counsel,
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`however, questioned Ms. Shoemaker about Medac’s marketing and development
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`of a commercial embodiment of the ’231 patent (Ex. 1040 at 34:9-16, 34:21-
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`35:13). Petitioner does not deny that this cross-examination was outside the scope
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`of Ms. Shoemaker’s declaration -- it relates to “what her declaration does not say,”
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`but asserts that it goes to her credibility. Resp. at 4-5. That is a makeweight. Ms.
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`Shoemaker’s declaration was credible, and Petitioner has not shown otherwise.
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`Her testimony about topics outside the declaration was also credible, and Petitioner
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`has not shown otherwise. Indeed, Petitioner has cited to its improper cross-
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`examination, not to impeach Ms. Shoemaker, but to make new arguments and
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`challenge a different witness’s testimony. Reply at 24. Moreover, Petitioner’s
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`“what the declaration does not say” standard would mean that there are no limits to
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`cross-examination. That is not the law. 37 C.F.R. § 42.53(d)(5)(ii). Accordingly,
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`Petitioner’s impermissible cross-examination and the arguments it makes from it
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`should be excluded.
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`III. Conclusion
`For the reasons above, the Board should exclude Exhibits 1041-1046 and the
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`improper cross-examination of Ms. Shoemaker.
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`Dated: October 23, 2017
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`
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`Respectfully submitted,
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`HALEY GUILIANO LLP
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`/James F. Haley, Jr./
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`James F. Haley, Jr. (Lead Counsel)
`75 Broad Street, Suite 1000
`New York, NY 10004
`T: 646-973-2500 / F: 646-219-6229
`james.haley@hglaw.com
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`Attorneys/Agents For Patent Owner
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies
`that
`the
`foregoing REPLY TO
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`PETITIONER’S OPPOSITION TO MOTION TO EXCLUDE EVIDENCE has
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`been served by filing this document through the Patent Trial and Appeal Board
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`End to End (PTAB E2E), as well as providing a courtesy copy via e-mail to the
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`following attorneys of record for the Petitioners listed below:
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`Lead Counsel:
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`DeAnn F. Smith, Reg. No. 36,683
`Foley Hoag LLP
`155 Seaport Blvd.
`Boston MA 02210-2600
`T: 617-832-1230
`dsmith@foleyhoag.com
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`ipr2016-01370@foleyhoag.com
`Back-up Counsel: William Rothwell, Reg. No. 72,522
`Noroozi PC
`2245 Texas Dr. Suite 300
`Sugar Land, TX 77479
`T: 281-566-2685
`william@noroozipc.com
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`Kayvan B. Noroozi
`Noroozi PC
`1299 Ocean Ave., Suite 450
`Santa Monica, CA 90401
`T.: 310-975-7074
`kayvan@noroozipc.com
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`Dated: October 23, 2017
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`By: /Crena Pacheco/
`Name: Crena Pacheco
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`ROPES & GRAY LLP
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`7
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