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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`COALITION FOR AFFORDABLE DRUGS II LLC,
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`Petitioner,
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`v.
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`NPS PHARMACEUTICALS, INC.
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`Patent Owner.
`____________
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`Cases IPR2015-00990 and IPR2015-01093
`(Patent 7,056,886 B2)1
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`PATENT OWNER’S MOTION TO EXCLUDE REPLY
`DECLARATION OF ANTHONY PALMIERI III (EX. 1041)
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`1 Pursuant to the Board’s Scheduling Order in these IPRs, “the word-for-word
`identical paper is filed in each proceeding identified in the heading.” See, e.g.,
`IPR2015-00990, Paper 29, footnote 1.
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`Table of Contents
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`Page
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`B.
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`INTRODUCTION .......................................................................................... 1
`I.
`LEGAL STANDARD FOR MOTION TO EXCLUDE ................................ 2
`II.
`III. ARGUMENT .................................................................................................. 4
`A.
`Identify Where in the Record the Objection Originally was
`Made ..................................................................................................... 4
`Identify Where in the Record the Evidence Sought to be
`Excluded was Relied Upon by an Opponent ........................................ 4
`C. Address Objections to Exhibits in Numerical Order ........................... 4
`D.
`Explain Each Objection ........................................................................ 4
`1.
`The Reply Declaration is Not Based on the Qualified
`Expertise of Dr. Palmieri and is Inadmissible ........................... 4
`Paragraphs 10-19 of the Reply Declaration Offer
`Inadmissible Hearsay and Irrelevant Testimony ..................... 11
`IV. CONCLUSION ............................................................................................. 14
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`2.
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`Pursuant to 37 C.F.R. 42.64(c), the Trial Practice Guide, 77 Fed. Reg. 157,
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`48756-73, 48767 (August 14, 2012) and the Scheduling Orders in these IPRs,
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`Patent Owner NPS Pharmaceuticals Inc. (“NPS”) submits this motion exclude the
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`Reply Declaration of Anthony Palmieri III, Ex. 1041.
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`I. INTRODUCTION
`The opinions in the Reply Declaration (Ex. 1041) are inadmissible under
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`Fed. R. Evid. 702. Dr. Palmieri has shown in his depositions that he is not qualified
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`to offer expert testimony in protein/peptide formulation science, which is the field
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`of the ‘886 patent. The opinions expressed in Ex. 1041 should be excluded because
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`they are not based on sufficient facts or data, they are not the product of reliable
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`principles and methods, and they are not reliably applied to the facts of this case.
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`Certain testimony is also inadmissible hearsay and irrelevant speculation
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`under Fed. R. Evid. 801 and 401. In Ex. 1041, ¶¶ 10-19, Dr. Palmieri purports to
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`know what was in the mind of the ‘886 inventor, as grounds for disregarding the
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`challenges the inventor faced. Dr. Palmieri of course has no personal knowledge of
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`the inventor’s work and no access to her thoughts. His opinions arising from
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`surmise about the inventor should be excluded. Such testimony is also irrelevant
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`under Rule 401, because the inventor is not a person of ordinary skill in the art, nor
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`is a patent required to identify any or all of the problems the invention overcame.
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`II. LEGAL STANDARD FOR MOTION TO EXCLUDE
`“A party wishing to challenge the admissibility of evidence must object
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`timely to the evidence at the point it is offered and then preserve the objection by
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`filing a motion to exclude the evidence.” Trial Practice Guide, 77 Fed. Reg. 48765,
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`48767 (Aug. 14, 2012) (citing 37 C.F.R. § 42.64). “A motion to exclude evidence
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`must: (a) Identify where in the record the objection originally was made; (b)
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`Identify where in the record the evidence sought to be excluded was relied upon by
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`an opponent; (c) Address objections to exhibits in numerical order; and (d) Explain
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`each objection. Id.
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`Expert testimony in an IPR is generally governed by the Federal Rules of
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`Evidence. 77 Fed. Reg. 157, at 48758. Fed. R. Evid. 702 (“Rule 702”) provides
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`that a witness must be “qualified as an expert by knowledge, skill, experience,
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`training, or education.” The testimony must be: (a) helpful specialized knowledge;
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`(b) “based on sufficient facts or data;” and (c) “the product of reliable principles
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`and methods;” which in turn are (d) “reliably applied … to the facts of the case.”
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`Rule 702 is consistent with Daubert v. Merrell Dow Pharmaceuticals, Inc.,
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`509 U.S. 579, 592-95 (1993), which provides for unreliable testimony to be
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`excluded. Pertinent factors under Daubert include whether the expert’s theory is
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`subjective and conclusory, has been subject to peer review and publication, and has
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`been generally accepted in the scientific community. Another factor is whether the
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`expert has developed opinions “expressly for purposes of testifying.” Daubert v.
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`Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1317 (9th Cir. 1995). An
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`opinion cannot extrapolate to an unfounded conclusion, General Elec. Co. v.
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`Joiner, 522 U.S. 136, 146 (1997), and cannot ignore other obvious explanations,
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`Claar v. Burlington N.R.R., 29 F.3d 499, 502-03 (9th Cir. 1994). The expert must
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`testify from a relevant and reliable discipline, Kumho Tire Co. v. Carmichael, 119
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`S.Ct. 1167, 1175 (1999), and must use “the same level of intellectual rigor that
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`characterizes the practice of an expert in the relevant field.” Sheehan v. Daily
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`Racing Form, Inc., 104 F.3d 940, 942 (7th Cir. 1997).
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`Hearsay evidence is inadmissible under Rule 801, when a statement, other
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`than one made by the declarant, is offered in evidence “to prove the truth of the
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`matter asserted.” Air Land Forwarders, Inc. v. US, 172 F. 3d 1338, 1342 (Fed. Cir.
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`1999). A “statement” under Rule 801 is defined as “a person’s oral assertion,
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`written assertion, or nonverbal conduct, if the person intended it as an assertion.”
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`“Irrelevant evidence is not admissible” under Rule 401 and 402, when the
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`evidence does not tend “to make a fact more or less probable than it would be
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`without the evidence” or the fact is not of “consequence in determining the action.”
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`Fed. R. Evid. 401 and 402; see also Daubert, 509 U.S. at 587
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`(1993); Magnivision, Inc. v. Bonneau Co., 115 F.3d 956, 961 (Fed. Cir. 1997).
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`The proponent of the evidence, in this case Petitioner, has the burden of
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`establishing admissibility by a preponderance of the evidence. See Fed. R. Evid.
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`104(a); Bourjaily v. United States, 483 U.S. 171 (1987).
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`III. ARGUMENT
`A.
`Identify Where in the Record the Objection Originally was Made
`Petitioner submitted the Reply Declaration (Ex. 1041) in connection with its
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`Replies in these IPRs (IPR2015-00990, Paper 42; IPR2015-01093, Paper 40).
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`Patent Owner objected to this Declaration in both IPRs (IPR2015-00990, Paper 45;
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`IPR2015-01093, Paper 43).
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`B.
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`Identify Where in the Record the Evidence Sought to be Excluded
`was Relied Upon by an Opponent
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`Petitioner relied upon Ex. 1041 on pages 3-21 of Petitioner’s Replies in
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`these IPRs (IPR2015-00990, Paper 42; IPR2015-01093, Paper 40).
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`C. Address Objections to Exhibits in Numerical Order
`Patent Owner objects to a single exhibit – Ex. 1041 – which is addressed
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`below.
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`D. Explain Each Objection
`1. The Reply Declaration is Not Based on the Qualified Expertise
`of Dr. Palmieri and is Inadmissible
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`Dr. Palmieri provided his qualifications as an expert by reference to his prior
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`declaration. Ex. 1041, ¶¶ 1, 5-7 (citing Ex. 1001, e.g., ¶¶ 4-6). He noted some
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`editorial positions, his publications, a faculty position in Pharmacy, and his
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`academic degrees in Pharmaceutics and Pharmacy. He asserted his research
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`interests and undergraduate teaching experience, including “pharmaceutical patents
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`and drug release.” Ex. 1001, ¶ 4. In the Reply Declaration he also noted his
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`retirement to adjunct status at the University of Florida. Ex. 1041, ¶¶ 5-7.
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`Significantly, the Reply Declaration made a new claim of expertise: “I am
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`well versed in the area of protein/peptide formulation.” Ex. 1041, ¶ 6. Dr. Palmieri
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`agreed that a “well-versed” expert is someone who is highly experienced, practiced
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`or skilled, very knowledgeable, or learned. Ex. 2171, 510:5-511:17.
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`The involved claims of U.S. Patent 7,056,886 are concerned with stable
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`formulations of peptides, i.e. “GLP-2 or an analog thereof,” including the
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`[Gly2]GLP-2 analog of claim 37, known as teduglutide, and used in Patent
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`Owner’s approved drug product, Gattex®. Ex. 1003; Ex. 1039. Petitioner admits
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`that relevant and reliable expertise in this case is in the “area of protein/peptide
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`formulation.” Ex. 1041, ¶ 6. However, Dr. Palmieri’s deposition testimony shows
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`that he is not at all “well versed” in proteins/peptides, their chemistry, their
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`formulation, or their stabilization. His “knowledge, skill, experience, training, or
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`education” does not extend to the matters at hand. Rule 702.
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`Dr. Palmieri testified that he has never published an article on protein
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`stabilization, peptide formulation, lyophilization, peptide degradation, glucagon,
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`GLP-2, or GLP-2 analogs. Ex. 2171, 333:12-334:19, 487:22-498:1. At least two of
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`his editorial board memberships are with publications that are not recognized peer
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`review journals. Id. at 337:21-338:11; Ex. 1041, ¶ 7. His one-time duties as a
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`formulation scientist, many years ago, involved talking with scientists, liaising
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`with the patent attorneys, obtaining generic names for products, and providing
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`input on trade names. Ex. 2171, 629:15-630:20. He has not worked on any peptide
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`formulations or peptide stabilization himself, nor published any papers in this area.
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`Ex. 2042, 30:12-32:11, 40:2-11. Indeed, he is unable to distinguish between
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`formulating peptides and formulating any other active pharmaceutical agent. Ex.
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`2042, 32:4-33:21, 35:13-36:10.
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`Other evidence that Dr. Palmieri is not a qualified expert includes:
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`(1) He does not understand optimum pH or how this impacts formulation
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`stability. Ex. 2171, 453:18-454:8.
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`(2) He does not understand “quality control” or “batch” processing in drug
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`manufacturing or how they impact formulation stability. Ex. 2171, 426:13-18.
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`(3) He does not have knowledge or experience concerning protein
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`denaturation (Ex. 2042, 310:10-15) or renaturation (Ex. 2042, 311:2-312:4).
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`(4) Although the ‘886 patent claims stable peptide formulations, he does not
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`have knowledge, and he did not explore, how peptide drugs degrade, nor did he
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`consider whether or not degradation pathways and circumventing them are
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`predictable. Instead, he subjectively concluded that such mechanisms are
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`irrelevant. Ex. 2042, 179:18-20, 180:8-11, 179:5-16, 181:4-182:3, 182:5-18, 183:6-
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`14, 185:15-21, 189:7-13, 196:10-197, 197:8-25, 198:4-7, 222:17-223:2, 223:8-
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`224:19, 230:25-27. Later, he admitted they are important, but he still did not
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`consider them. Ex. 2171, 478:11-479:8, 570:19-25, 600:20-601:25; see also Reply2
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`at 2, 16-17; Ex. 1041, ¶¶ 10, 77, 80, 81, 95, 100.
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`(5) He did not consider basic properties of GLP-2 or its analogs (Ex. 2042,
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`206:16-22), nor how they degrade, nor how such degradation may compare to
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`glucagon, which he alleges is the closest prior art. See Ex. 1001, e.g., ¶ 36; Ex.
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`1041, e.g., ¶ 18; Ex. 2042 74:10-75:9 (re Osterberg), 90:4-17 (re Kornfelt), 190:7-
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`196:8, 200:16-201:21, 209:12-20, 215:21-222:14, 288:20-25; see also Ex. 2171
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`618:19-25, 630:21-633:16, 637:24-638:15 (degradation of asparagine, tyrosine,
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`and methionine), 618:7-24 and 619:9-16 (tertiary structure), 626:3-20, 619:18-
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`622:11, 626:4-20, 631:9-633:16, 637:21-638:15 (degradation at different positions
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`in GLP-2 and glucagon).
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`(6) He did not know and did consider whether stabilizing a protein generally,
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`or stabilizing the peptides GLP-2 or its analogs, would be predictable or
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`unpredictable in view of aggregation (Ex. 2042, 112:6-16, 192:20-196:8, 179:18-
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`2 For convenience, citations to “Reply” herein encompass both IPRs, but refer
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`specifically to Paper 42 in IPR2015-00990. Paper 40 in IPR2015-01093 is
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`substantively identical and has different pagination.
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`183:14, 230:8-234:4); hydrolysis (id. at 181:4-182:3); oxidation (id. at 196:10-
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`197:25, 202:6-14, 222:4-12); buffer salts (id. at 216:2-19); deamidation (id. at
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`220:12-223:2); peptide cleavage (id. at 223:21-224:7); Malliard reactions (id. at
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`225:19-226:5); physical degradation (id. at 238:16-22); or apolar surfaces (id. at
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`191:3-12); see also Reply at 16-17 and Ex. 1041, ¶¶ 10, 77, 80, 81, 95, 100.
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`(7) He confused different amino acids and did not know their abbreviations
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`(Ex. 2171, 602:25-604:6, 622:12-624:22, 632:22-633:4), nor could he determine
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`the amino acid sequence of [Gly2]GLP-2 (teduglutide) (id. at 605:12-607:5,
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`611:19-613:13, 617:15-618:5).
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`Dr. Palmieri also is not equipped to interpret the ‘866 patent or its claims:
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`(8) He does not know whether the claims encompass reactions with GLP-2
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`or analogs (Ex. 2171, 315:23-346:5), nor whether the claims require GLP-2 or
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`analogs to have biological activity (id. at 348:21-349:4; c.f. Ex. 1003, claims 32,
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`44, 51, 60, 68, 75; Ex. 1041, ¶¶ 49, 50).
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`(9) He does not know whether the claims encompass mannitol plus sucrose.
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`Ex. 2171, 498:25-499:9; c.f. Ex. 1003, claims 1, 46, 52, 53, 61, 69.
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`(10) He does not know whether the claims encompass the [Gly2]GLP-2
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`analog, despite express claim language. Ex. 2171, 582:3-590:2; see Ex. 1041, ¶ 49;
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`c.f. Ex. 1003, claims 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 45, 47, 64, 72.
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`(11) He does not know whether the claims encompass formulations that are
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`to be injected. Ex. 2921, at 399:15-700:3; c.f. Ex. 1003, claims 65, 73.
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`(12) He does not know the meaning of “stable,” even in claims with express
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`stability criteria. Ex. 2171, 370:24-371:7; Ex. 1041, ¶ 9, 53-60, 66, 94, 95, 107; c.f.
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`Ex. 1003, claim 66.
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`Dr. Palmieri testified that he would need to consult others in order to
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`consider the potential degradation pathways for a protein/peptide formulation,
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`although he did not do so for this case. See Ex. 2042, 196:22-197:6; Ex. 2171,
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`600:20-601:25, 570:20-25. He could “look up,” but did not know to consider the
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`stabilization properties and potential problems of claimed components and features
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`of the ‘886 formulations, such as histidine (Ex. 2042, 63:10-16, 75:20-76:9),
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`phosphate buffers (Ex. 2042 106:5-10) and lyophilization (Ex. 2042, 83:11-84:8,
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`164:21-165:10, 236:16-22, 239:21-24). Likewise, he would need to consult others,
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`but did not do so, to determine whether one could screen for GLP-2 analogs that
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`bind to the GLP-2 receptor (Ex. 2171, 350:8-15, 351:17-352:14). He would even
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`need someone to tell him the difference between a protein and a peptide, and
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`whether GLP-2 in the involved ‘886 claims is a protein or a peptide. Id. at 398:23-
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`399:6, 527:3-8.
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`In Ex. 1001, at ¶ 22, Dr. Palmieri described a person of ordinary skill in the
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`art of the ‘886 invention as having, inter alia, “knowledge of formulating peptide
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`formulations and of
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`the clinical application of
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`therapeutics
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`in
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`treating
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`gastrointestinal disorders.” See also IPR2015-00990, Paper 1 at 21; IPR2015-
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`01093, Paper 1 at 21; IPR2015-00990, Paper 33 at 3; IPR2015-01093, Paper 31 at
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`3; Ex. 2048, ¶ 30 (relevant expertise includes protein/peptide formulation science).
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`However, Dr. Palmieri’s stated credentials did not originally include such
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`knowledge or expertise. He did claim later that he has a vague familiarity with
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`“protein/peptide formulation” (Ex. 1041, ¶ 6), but he gave no support for this
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`claim, beyond the words: “I am well versed.”
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`The cumulative effect of Dr. Palmieri’s testimony shows that he is very far
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`from well-versed in the area of protein/peptide formulation; he is not even
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`conversant with its fundamentals. He repeatedly admitted he would need to look
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`things up or seek out other experts, even to answer fundamental questions of
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`protein/peptide formulation science -- but he did not do so for his testimony in this
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`case. He does not possess the helpful specialized knowledge Rule 702
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`contemplates, and he did not apply the scientific rigor that he admits would be
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`required. Sheehan, 104 F.3d at 942. He is not aware of many relevant and material
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`facts, and he did not apply reliable principles and methods, as Rule 702
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`contemplates, such as evaluating the impact of protein/peptide degradation on
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`stabilizing a peptide formulation. Instead, he subjectively dismissed these
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`obviously relevant considerations, in favor of an unsupported conclusion that they
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`are categorically irrelevant, which he later retracted. Daubert, 509 U.S. at 592-95;
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`Claar, 29 F.3d at 502-03.
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`Dr. Palmieri may have read the ‘866 patent (Ex. 1003) and the Carpenter
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`Declaration (Ex. 1041, ¶ 2), and he may have read some literature, but he is not
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`qualified to give reliable expert opinions upon them. His Reply Declaration (Ex.
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`1041) should be excluded, in its entirety.
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`2. Paragraphs 10-19 of the Reply Declaration Offer Inadmissible
`Hearsay and Irrelevant Testimony
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`Dr. Palmieri has testified: “The inventor of the ‘886 patent did not consider
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`the characteristics of GLP-2 or analogs thereof that Dr. Carpenter discusses at
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`length as complexities in formulating proteins/peptides.” Ex. 1041, ¶ 10. Similarly,
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`he states: “from my review of the ‘886 patent specification, I do not see that these
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`issues were ever emphasized by the inventor in order to provide a sufficient
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`disclosure.” Id. at ¶ 11; see also id. at ¶¶ 12-16.
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`Dr. Palmieri admits he has no knowledge of what the ‘886 inventor did or
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`did not consider when making his invention. He never met the inventor nor had
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`any discussions with her. Ex. 2171, 347:14-348:10. At best, Dr. Palmieri can only
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`say, by reading the patent, that it does not set forth all of the obstacles that the
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`invention overcame. In this regard Dr. Palmieri is no more “expert” than any reader
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`of the patent. He certainly has no personal knowledge of what the inventors
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`considered, or not, and his testimony to that effect, as rebuttal to Dr. Carpenter, is
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`either conspicuously irrelevant, fabricated hearsay, or both. Fed. R. Civ. 401, 801.
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`See Bone Care Int’l et al. v. Pentech Pharm., Inc., 2010 U.S. Dist. LEXIS 105118,
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`at *31-32, * 47 (N.D. Ill. 2010) (citing Se-Kure Controls, Inc. v. Diam USA, Inc.,
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`2009 U.S. Dist. LEXIS 1648, at *2 (N.D. Ill. Jan. 9, 2009) (expert is not mind
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`reader and may not testify to inventor’s intent). An expert opinion cannot
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`extrapolate to an unfounded conclusion, as by using impermissible hindsight from
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`the ‘886 patent to mind-read the inventor, as a dispute-driven theory by which the
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`unpredictability of stabilizing peptides is ignored. Rule 702; General Elec. Co.,
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`522 U.S. at 146; Daubert, 509 U.S. at 592-95.
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`The testimony in Ex. 1041, ¶¶ 10-16 is also irrelevant under Fed. R. Civ.
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`401, because the predictability of an invention, its obviousness, and the presence or
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`absence of unexpected results, is seen through the eyes of a “person of ordinary
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`skill in the art,” not through the eyes of the inventor. The inventor’s knowledge of
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`obstacles, or lack thereof, is irrelevant. See Pre-AIA 35 U.S.C. § 103
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`(“Patentability shall not be negatived by the manner in which the invention was
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`made.”); see also Kimberly-Clark Corp. v. Johnson & Johnson, 745 F. 2d 1437,
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`1454 (Fed, Cir. 1984) (hypothetical person of ordinary skill is not the inventor).
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`“Instead of ascertaining what was subjectively obvious to the inventor at the time
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`of invention, the court must ascertain what would have been objectively obvious to
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`one of ordinary skill in the art at such time.” Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.
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`2d 714, 718 (Fed. Cir. 1991). This is something else that Dr. Palmieri did not know.
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`Ex. 2171, 340:4-341:5, 593:12-20; Reply at 3.
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`Dr. Palmieri complains that the patent discloses at least some, but not all of
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`the obstacles identified by Dr. Carpenter. See Ex. 1041, ¶ 12. This is irrelevant. A
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`patent specification is not required, under 35 U.S.C. § 112 or otherwise, to identify
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`any one or all of the problems the invention overcame. Contrary to Dr. Palmieri’s
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`insinuations (Ex. 1041, ¶ 11), the patent specification sets forth and claims stable
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`formulations of GLP-2 and GLP-2 analogs. The specification need not explain how
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`or why the invention works, nor catalog the inventor’s difficulties. See Alcon
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`Research Ltd. v. Barr Laboratories, Inc., 745 F.3d 1180, 1190 (Fed. Cir. 2014);
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`Exxon Chemical Patents, Inc. v. Lubrizol Corp., 64 F.3d 1553, 1567 (Fed. Cir.
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`1995) (quoting Diamond Rubber Co. v. Consolidated Rubber Tire Co., 220 U.S.
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`428, 435-36 (1911) (inventor may not know all forces he brought into operation;
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`“not necessary that he understand or be able to state the scientific principles
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`underlying his invention”); Fromson v. Advance Offset Plate, Inc., 720 F.2d 1565,
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`1570 (Fed. Cir. 1983) (“axiomatic that an inventor need not comprehend the
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`scientific principles on which … his invention rests”).
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`To the extent Ex. 1041 at ¶¶ 10-19 (see, e.g. ¶ 11) implies non-enablement
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`of the ‘866 claims, the testimony is further irrelevant and should be excluded,
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`because 35 U.S.C. § 112 cannot be grounds for challenging a patent in an IPR. See
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`35 U.S.C. § 311(b); 35 U.S.C. § 318(a).
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`For all of the reasons given above, Dr. Palmieri’s opinions in Ex. 1041, ¶¶
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`10-19 should be excluded from these proceedings.
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`IV. CONCLUSION
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`Patent Owner respectfully requests that its MOTION TO EXCLUDE
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`DECLARATION EVIDENCE OF DR. ANTHONY PALMIERI III be granted.
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`Dated: May 18, 2016
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` Respectfully submitted,
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`/Joseph R. Robinson/
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`Joseph R. Robinson, PTO Reg. No. 33,448
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` Heather M. Ettinger, PTO Reg. No. 51,658
` Dustin B. Weeks, PTO Reg. No. 67,466
` Attorneys for Patent Owner
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`28525889v1
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`14
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`IPR2015-00990; -01093
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PATENT
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`OWNER’S MOTION TO EXCLUDE REPLY DECLARATION OF DR.
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`ANTHONY PALMIERI III has been on attorney for Petitioner, served via
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`electronic mail on May 18, 2016, to the following addresses provided by
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`Petitioner:
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`Jeffrey D. Blake, Esq.
`jblake@merchantgould.com
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`Dated: May 18, 2016
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` Respectfully submitted,
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`/Dustin B. Weeks/
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` Dustin B. Weeks, PTO Reg. No. 67,466
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`28525889v1