`
`Jeffrey D. Blake, Esq.
`Matthew L. Fedowitz, Esq.
`MERCHANT & GOULD P.C.
`191 Peachtree Street N.E., Suite 3800
`Atlanta, GA 30303
`jblake@merchantgould.com
`mfedowitz@merchantgould.com
`Main Telephone: (404) 954-5100
`Main Facsimile: (404) 954-5099
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`COALITION FOR AFFORDABLE DRUGS II LLC
`Petitioner
`
`
`
`v.
`
`
`
`NPS PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`Case No. IPR2015-01093
`Patent No. 7,056,886
`_____________________
`
`
`
`
`
`PETITIONER’S RESPONSE TO MOTION PRESENTING PATENT
`OWNER’S OBSERVATIONS REGARDING CROSS-EXAMINATION OF
`ANTHONY PALMIERI, Ph.D.
`
`
`
`I.
`
`INTRODUCTION
`
`The Coalition for Affordable Drugs II LLC (“Petitioner”) submits this
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`Response to the Motion Presenting Patent Owner’s Observations Regarding Cross-
`
`Examination of Anthony Palmieri, Ph.D. (Paper 47, “Observations”). These
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`responses to observations are timely submitted pursuant to a joint stipulation
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`between the parties resetting the due date for these responses to May 31, 2016.
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`On May 27, 2016, a teleconference between the Board and the parties was
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`held to provide guidance on how Petitioner should respond to Patent Owner’s
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`improper Observations. During the teleconference, the Board authorized Petitioner
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`to include an introduction in its Response to Patent Owner’s Observations
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`explaining Petitioner’s objections and stating the relevant authority for those
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`objections.
`
`A.
`
`Patent Owner’s Observations are an Unauthorized Sur-Reply
`
`The Trial Practice Guide, 77 Fed. Reg. 157, 48756-73 (August 14, 2012)
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`clearly explains the purpose of observations on cross-examination is to draw the
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`Board’s attention to relevant cross-examination testimony that “occurs after a party
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`has filed its last substantive paper on an issue.” Chums, Inc. v. Cablz, Inc.
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`IPR2014-01240, Paper 32, page 2. The Trial Practice Guide, 77 Fed. Reg. 157,
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`48756-73 (August 14, 2012) sets forth requirements for observations on cross-
`
`examination.
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`1
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`
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`An observation should be a concise statement of the relevance of
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`identified testimony to an identified argument or portion of an exhibit
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`(including another part of the same testimony)…An observation…is
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`not an opportunity to raise new issues, re-argue issues, or pursue
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`objections. Each observation should be in the following form:
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`In exhibit __, on page __, lines __, the witness testified __. This
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`testimony is relevant to the __ on page __ of __. The testimony is
`
`relevant because __.
`
`Rather than following the Trial Practice Guide, Patent Owner instead filed
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`Observations that are in the improper format, excessively long, argumentative, and
`
`attempt to introduce new exhibits into the record. These Observations amount to an
`
`unauthorized sur-reply filed under the veil of Observations. If Patent Owner
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`wished to respond to arguments in the Petitioner’s reply, the proper mechanism
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`was to contact the Board and request permission for a sur-reply. Patent Owner
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`chose not to do so, and it should not be allowed to submit a sur-reply through
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`improper observations. See Medtronic, Inc. v. NuVasive, Inc., IPR2013-00506,
`
`Paper 37.
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`B. Requirements for Filing Observations
`
`Each of the Observations provided for Dr. Palmieri do not follow the format
`
`required by the Trial Practice Guide as set forth above. See Observations 1-33.
`
`2
`
`
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`Instead, Patent Owner’s Observations attempt to masquerade as being in the proper
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`format by using phrases and terms such as “the witness testified” and “relevant.”
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`However, a cursory review of Dr. Palmieri’s Observations reveal that they do not
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`follow the Board’s required format. Id.
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`
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`The same is true regarding the argumentative nature of Patent Owner’s
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`Observations, which resemble a brief and are an attempt to introduce new
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`evidence, re-argue issues and raise new issues. See Observation 3 arguing that Dr.
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`Palmieri “misstated that Dr. Carpenter agreed that a formulator would not need to
`
`know formulation basics and would consult others for basics”; Observations 24
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`and 25 arguing that the identified testimony “evidences [Dr. Palmieri’s] lack of
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`expertise and his use of hindsight”; and Observation 32 raising the new issue that
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`“Petitioner attempts to raise enablement issues in these IPRs.”
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`
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`This is improper as the Board is clear in its requirements that observations
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`must be a concise statement of the relevance of precisely identified testimony to a
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`precisely identified argument or portion of an exhibit. Medtronic, Inc. v. NuVasive,
`
`Inc., IPR2013-00506, Paper 37, p. 2. In addition, the entire observation should not
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`exceed one short paragraph. Id. Patent Owner’s Observations disregard this
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`requirement. See Observations 1, 2, 5, 8, 9, 10, 12, 14, 15, 18, 20, 22, and 27.
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`
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`Further, each observation should cite to one portion of testimony and not
`
`several pages and this is a basis upon which observations may be
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`3
`
`
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`dismissed. Medtronic, Inc. v. NuVasive, Inc., IPR2013-00506, Paper 37, pp 3-4.
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`Patent Owner also did not follow this requirement. For example, Observation 1
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`provides seventeen citations to Ex. 2171 (333:12-334:19; 487:22-498:1; 337:21-
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`338:11; 629:15-630:20; 453:18-454:8; 426:13-18; 570:15-25; 602:25-603:4;
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`603:24-604:6; 622:12-624:5; 624:16-22; 632:22-633:4; 605:12-606:2; 606:13-
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`607:5; 611:19-613:13; 617:15-618:5; and 692:3-696:7). In fact, many citations are
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`to extended portions of deposition transcript spanning multiple pages, such as
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`333:12-334:19, 487:22-498:1, 622:12-624:5, 611:19-613:13, and 692:3-696:7 for
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`Observation 1 alone. See also Observations 2-9, 12-18, 25, and 33 as additional
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`examples of improperly providing citations to multiple portions of testimony in a
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`similar manner as Observation 1.
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`
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`The Board may refuse entry of excessively long or argumentative
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`observations. Trial Practice Guide at p. 48768; and, Medtronic, Inc. v. NuVasive,
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`Inc., IPR2013-00506, Paper 37, p. 2. Indeed, the majority of Patent Owner’s
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`Observations are lengthy. See Observations 1, 2, 5, 8, 9, 10, 12, 14, 15, 18, 20, 22,
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`and 27. The Board has precedent for dismissing excessively long observations.
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`Medtronic, Inc. v. NuVasive, Inc., IPR2013-00506, Paper 37, page 3.
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`
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`Finally, the Board has held that no new exhibits are permitted with
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`Observations by stating that only testimony from cross-examination should be
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`present in Observations. Medtronic, Inc. v. NuVasive, Inc., IPR2013-00506, Paper
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`4
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`
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`37, page 4, footnote 2. Again, Patent Owner did not follow this requirement. For
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`example, Observation 10, in the first instance, cites to Dr. Palmieri’s deposition
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`transcript from December 10, 2015 (citations with pages numbers lower than page
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`318 are from the Palmieri Deposition transcript dated December 10, 2015). Dr.
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`Palmieri’s deposition from December 10, 2015 is not the subject of Observations,
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`rather that testimony was addressed in Patent Owner’s formal Opposition filed on
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`January 20, 2016.
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`Given that Patent Owner’s Observations are argumentative, fail to follow the
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`proper format set forth in the Trial Practice Guide, excessively long, and attempt to
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`introduce new exhibits into the record, these Observations amount to an
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`unauthorized sur-reply. Accordingly, Petitioner objects to them.
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`II.
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`RESPONSES TO OBSERVATIONS
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`A. Response to Observations 1-4, 24, and 25
`
`i.
`
`In Ex. 2171, on p. 335, l. 17-p. 336, l. 4, Dr. Palmieri testified
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`to his expertise in pharmaceutics and his extensive list of publications. This
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`testimony is relevant to Dr. Palmieri’s expertise and qualifications as set forth in
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`his Reply Declaration (Ex. 1041, paragraphs 5-7) and Initial Declaration (Ex. 1001,
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`paragraphs 4-7).
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`ii.
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`In Ex. 2171, on p. 359, l. 15-p. 361, line 3, Dr. Palmieri
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`testified to the level of one of ordinary skill in the art. This testimony is relevant to
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`5
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`
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`paragraph 10 of Dr. Palmieri’s Reply Declaration (Ex. 1041). This testimony is
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`also relevant to Dr. Palmieri’s expertise and qualifications as set forth in his Reply
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`Declaration (Ex. 1041, paragraphs 5-7) and Initial Declaration (Ex. 1001,
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`paragraphs 4-7).
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`iii.
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`In Ex. 2171, on p. 361, l. 16-p. 363, line 9, Dr. Palmieri
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`testified to the level of one of ordinary skill in the art and what that individual
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`would consider a finite number of excipients to work with in formulating
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`glucagon-like peptide-2 (GLP-2). This testimony is relevant to paragraph 10 of
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`Dr. Palmieri’s Reply Declaration (Ex. 1041) and to choosing excipients in
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`formulating GLP-2. This testimony is also relevant to Dr. Palmieri’s Reply
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`Declaration (Ex. 1041) where he addresses finite combinations and excipients at
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`paragraphs 22, 24, 63, and 68-70.
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`iv.
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`In Ex. 2171, on p. 509, l. 24-p. 510, l. 2, Dr. Palmieri testified
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`to his being well-versed in the area of protein/peptide formulation. This testimony
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`is relevant to Dr. Palmieri’s expertise and qualifications as set forth in his Reply
`
`Declaration (Ex. 1041, paragraphs 5-7) and Initial Declaration (Ex. 1001,
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`paragraphs 4-7).
`
`v.
`
`In Ex. 2171, on p. 575, l. 13-p. 576, l. 3, Dr. Palmieri testified
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`to Dr. Carpenter’s admission that a one of ordinary skill in the art could work in a
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`team in developing a lyophilized formulation. This testimony is relevant to Dr.
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`6
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`
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`Palmieri’s expertise and the credibility of Dr. Carpenter. This testimony is also
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`relevant to Dr. Palmieri’s Reply Declaration (Ex. 1041) where he addresses
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`working in a team at paragraphs 32, 33, 36, and 43.
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`vi.
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`In Ex. 2171, on p. 426, ll. 20-25, Dr. Palmieri said he
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`understands “what quality control testing is” and knows “there are different ways
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`to do quality control testing.” This testimony is relevant to Ex. 2171, 426:13-18
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`because it demonstrates Dr. Palmieri’s expertise.
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`B. Response to Observation 5
`
`i.
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`In Ex. 2171, on p. 378, l. 25-p. 379, l. 15, Dr. Palmieri testified
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`how he reached the conclusion that the claims at issue are obvious. This testimony
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`is relevant to the basis of Dr. Palmieri’s conclusions on the issue of obviousness of
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`the claims at issue as set forth in Dr. Palmieri’s Initial Declaration (Ex. 1001) at
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`paragraphs 45-216 and his Reply Declaration (Ex. 1041) at paragraphs 9-10 and
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`53-60.
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`C. Response to Observations 6 and 32
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`i.
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`In Ex. 2171, on p. 349, ll. 5-24, Dr. Palmieri testified to the
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`disclosure in U.S. Patent No. 7,056,886 (“the ‘886 patent”). This testimony is
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`relevant to whether or not the complexities Dr. Carpenter describes were even
`
`considered to be complexities based on the disclosure of the ‘886 patent. This
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`testimony is also relevant to Dr. Palmieri’s Reply Declaration (Ex. 1041) at
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`7
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`
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`paragraphs 11-19 where he describes how the ‘886 patent does not recognize any
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`of the “complexities” associated with peptide formulation that Dr. Carpenter
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`discusses.
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`D. Response to Observations 7-11 and 23
`
`i.
`
`In Ex. 2171, on p. 345, l. 23-p. 346, l. 14, Dr. Palmieri testified
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`to how the claims at issue do not relate to degradation but rather the formulations.
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`This testimony is relevant to whether the degradation reactions are pertinent to the
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`obviousness of the claims at issue as well as being relevant to Dr. Palmieri’s Reply
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`Declaration (Ex. 1041) at paragraphs 11-34 and 77-81.
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`ii.
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`In Ex. 2171, on p. 441, l. 14-p. 442, l. 22, Dr. Palmieri testified
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`to Dr. Carpenter’s admission that degradative reactions can be slowed sufficiently
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`so that a protein product remains stable for months or years. This testimony is
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`relevant to the credibility of Dr. Carpenter as well as being relevant to the
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`testimony provided in Dr. Palmieri’s Reply Declaration (Ex. 1041) at paragraphs
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`11-34 and 77-81.
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`iii.
`
`In Ex. 2171, on p. 650, l. 22-p. 652, l. 15, Dr. Palmieri testified
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`to the disclosure of Ex. 2052 being published after the priority date of the ‘886
`
`patent and that it would not impact his obviousness analysis. This testimony is
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`relevant to whether Ex. 2052 is relevant and Dr. Palmieri’s Reply Declaration (Ex.
`
`1041) at paragraph 85.
`
`8
`
`
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`
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`E. Response to Observation 12
`
`i.
`
`In Ex. 2171, on p. 414, l. 7-p. 415, l. 19, Dr. Palmieri testified
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`to the deficiencies in Figure 5 of the ‘886 patent and its related Example. This
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`testimony is relevant to Dr. Palmieri’s Reply Declaration (Ex. 1041) at paragraphs
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`121-126 discussing how the Figure does not provide the results Dr. Carpenter
`
`alleges and that the results in Figures 5 and 6 are not surprising and unexpected in
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`view of Dr. Carpenter’s statement that Kornfelt found mannitol and lactose
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`equivalent in glucagon formulations, and also Dr. Carpenter’s failure to read
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`Kornfelt as a whole.
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`F. Response to Observations 14-16
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`i.
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`In Ex. 2171, on p. 371, ll. 9-16, Dr. Palmieri testified that his
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`opinions on obviousness are independent of Dr. Carpenter’s 1996 and 1997
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`publications (Exs. 1049 and 1050). This testimony is relevant to paragraph 69 of
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`Dr. Palmieri’s Reply Declaration (Ex. 1041) and demonstrates that he maintains
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`that the claims at issue are obvious based on the Grounds set forth in his Initial
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`Declaration. This testimony is also relevant to the basis of Dr. Palmieri’s
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`conclusions on the issue of obviousness of the claims at issue as set forth in Dr.
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`Palmieri’s Initial Declaration (Ex. 1001) at paragraphs 45-216 and his Reply
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`Declaration (Ex. 1041) at paragraphs 9-10 and 53-60.
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`9
`
`
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`ii.
`
`In Ex. 2171, on p. 525, ll. 8-22, Dr. Palmieri testified to
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`disclosures in Dr. Carpenter’s book chapter (Ex. 1049). This testimony is relevant
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`to the credibility of Dr. Carpenter. This testimony is also relevant to Dr. Palmieri’s
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`Reply Declaration (Ex. 1041) at paragraphs 20-43 discussing how Dr. Carpenter’s
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`previous publications contradict his declaration and support Petitioner’s positions.
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`G. Response to Observations 16, 24, 29, and 31
`
`i.
`
`In Ex. 2171, on p. 398, l. 22-p. 399, l. 15, Dr. Palmieri testified
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`that glucagon was similar to glucagon-like peptide-2 (GLP-2). This testimony is
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`relevant to using what was known in the art for stabilizing glucagon and applying
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`it to stabilizing glucagon-like peptide-2 using routine experimentation. This
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`testimony is also relevant to Dr. Palmieri’s Reply Declaration (Ex. 1041)
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`paragraphs 80-81 discussing how it is logical that a correlation can be drawn
`
`between what occurs during the degradation of glucagon and glucagon-like
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`peptide-2 and methods to stabilize glucagon could be applied to glucagon-like
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`peptide-2 or analogs thereof.
`
`ii.
`
`In Ex. 2171, on p. 607, l. 10-p. 608, l. 4, Dr. Palmieri testified
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`that he believed [Gly2]GLP-2 has a glycine at the two position of GLP-2, but
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`would want to confirm that this is the sequence by checking a reference. This
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`testimony is relevant to Ex. 2171, 605:12-606:2, 606:13-607:5, 611:19-613:13, and
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`617:15-618:5 because it shows Dr. Palmieri understands the sequence of
`
`10
`
`
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`[Gly2]GLP-2. This testimony is also relevant to Dr. Palmieri’s Reply Declaration
`
`(Ex. 1041) at paragraphs 17, 51, and 124.
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`H. Response to Observations 13,17, 30, and 33
`
`i.
`
`In Ex. 2171, on p. 361, l. 16-p. 363, l. 9, Dr. Palmieri testified
`
`to the level of one of ordinary skill in the art and what that individual would
`
`consider a finite number of excipients to work with in formulating GLP-2. This
`
`testimony is relevant to paragraph 10 of Dr. Palmieri’s Reply Declaration (Ex.
`
`1041) and to choosing excipients in formulating GLP-2. This testimony is also
`
`relevant to Dr. Palmieri’s Reply Declaration (Ex. 1041) where he addresses finite
`
`combinations and excipients at paragraphs 22, 24, 63, and 68-70.
`
`ii.
`
`In Ex. 2171, on p. 364, l. 14-p. 365, l. 16, Dr. Palmieri testified
`
`to the choice of routine excipients in lyophilization. This testimony is relevant to
`
`choosing excipients in formulating GLP-2. This testimony is also relevant to
`
`paragraph 10 of Dr. Palmieri’s Reply Declaration (Ex. 1041) and to choosing
`
`excipients in formulating GLP-2. This testimony is also relevant to Dr. Palmieri’s
`
`Reply Declaration (Ex. 1041) where he addresses finite combinations and
`
`excipients at paragraphs 22, 24, 63, and 68-70.
`
`iii.
`
`In Ex. 2171, on p. 368, l. 18-p. 369, l. 17, Dr. Palmieri testified
`
`to the choice of excipients for reducing residual moisture during lyophilization.
`
`This testimony is relevant to common knowledge in choosing excipients for
`
`11
`
`
`
`lyophilization. This testimony is also relevant to paragraph 10 of Dr. Palmieri’s
`
`Reply Declaration (Ex. 1041) and to choosing excipients in formulating GLP-2.
`
`This testimony is also relevant to Dr. Palmieri’s Reply Declaration (Ex. 1041)
`
`where he addresses finite combinations and excipients at paragraphs 22, 24, 63,
`
`and 68-70.
`
`I. Response to Observations 18-22
`
`i.
`
`In Ex. 2171, on p. 528, ll. 8-20, Dr. Palmieri testified to Dr.
`
`Carpenter’s admissions in his publications that sugars prevent denaturation. This
`
`testimony is relevant to Dr. Palmieri’s Reply Declaration (Ex. 1041) at paragraphs
`
`25 and 27 discussing choosing excipients that are useful for stabilizing lyophilized
`
`proteins and maintaining secondary protein/peptide structure. It is also relevant to
`
`the credibility of Dr. Carpenter.
`
`ii.
`
`In Ex. 2171, on p. 533, ll. 10-17, Dr. Palmieri testified the
`
`earliest use of sucrose to stabilize proteins was in 1935. This testimony is relevant
`
`to Dr. Palmieri’s Reply Declaration (Ex. 1041) at paragraphs 25 and 27 where he
`
`discusses the earliest use of sucrose to stabilize proteins being more than 80 years
`
`ago in 1935 as well as how sucrose has been known to protect proteins during
`
`dehydration/rehydration since at least 1935. It is also relevant to the credibility of
`
`Dr. Carpenter.
`
`12
`
`
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`iii.
`
`In Ex. 2171, on p. 639, l. 21-p. 640, l. 21, Dr. Palmieri testified
`
`to the native form of glucagon having a helical conformer induced or selected at
`
`the receptor from a population of conformers. This testimony is relevant to
`
`secondary structure and the disclosure in Ex. 2050. This testimony is also relevant
`
`to Dr. Palmieri’s Reply Declaration (Ex. 1041) at paragraph 89 where he discusses
`
`how Blundell (Ex. 2050) supports his position contrary to Dr. Carpenter’s
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`testimony.
`
`J.
`
`Response to Observations 26-28
`
`i.
`
`In Ex. 2171, on p. 480, ll. 11-19, Dr. Palmieri testified that
`
`optimum pH relates to a compound’s degradation profile and also explained
`
`optimum pH is available through routine experimentation. This testimony is
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`relevant to Ex. 2171, 453:18-454:8 because it demonstrates that that optimum pH
`
`can be easily ascertained. This testimony is also relevant to Dr. Palmieri’s Reply
`
`Declaration (Ex. 1041) at paragraphs 64-67 where he describes how Dr. Carpenter
`
`ignores Kornfelt’s disclosure of a broad pH range.
`
`III.
`
`
`CONCLUSION
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`
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`No fees are required for filing this Response; however, the Commissioner is
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`authorized to charge any additional fees which may be required, or credit any
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`overpayment, to Deposit Account No. 13-2725.
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`
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`13
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`
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`Date: May 31, 2016
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`
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`Respectfully submitted,
`
`
`
`
`
`By: /s/ Matthew L. Fedowitz
`Jeffrey D. Blake, Esq., Reg. No. 58,886
`Matthew L. Fedowitz, Esq., Reg. No. 61,386
`MERCHANT & GOULD P.C.
`191 Peachtree Street N.E., Suite 3800
`Atlanta, GA 30303
`jblake@merchantgould.com
`mfedowitz@merchantgould.com
`Main Telephone: (404) 954-5100
`Main Facsimile: (404) 954-5099
`
`Counsel for Petitioner
`
`
`
`14
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`
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`Certification of Service
`
`Pursuant to 37 C.F.R § 42.6, the undersigned hereby certifies that a copy of
`
`this PETITIONER’S RESPONSE TO MOTION PRESENTING PATENT
`
`OWNER’S OBSERVATIONS REGARDING CROSS-EXAMINATION OF
`
`ANTHONY PALMIERI, Ph.D. has been served on May 31, 2016 by email on
`
`counsel of record for the Patent Owner as follows:
`
`
`Joseph R. Robinson
`Heather Morehouse Ettinger
`Troutman Sanders LLP
`The Chrysler Building
`405 Lexington Avenue
`New York, NY 10174-0700
`joseph.robinson@troutmansanders.com
`heather.ettinger@troutmansanders.com
`
`Dustin B. Weeks
`Troutman Sanders LLP
`Bank of America Plaza
`600 Peachtree Street NE, Suite 5200
`Atlanta, GA 30308-2231
`dustin.weeks@troutmansanders.com
`
`
`
`Date: May 31, 2016
`
`
`
`Respectfully submitted,
`
`
`
`/s/ Matthew L. Fedowitz
`Matthew L. Fedowitz, Reg. No. 61,386
`MERCHANT & GOULD P.C.
`Attorney for Petitioner CFAD
`
`15