throbber
IPR2015-00990; -01093
`
`IN THE 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.
`____________
`
`
`Cases IPR2015-00990 and IPR2015-01093
`(Patent 7,056,886 B2)1
`
`
`PATENT OWNER’S MOTION TO EXCLUDE REPLY
`DECLARATION OF ANTHONY PALMIERI III (EX. 1041)
`
`
`
`
`
`
`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.
`
`

`
`Table of Contents
`
`
`Page
`
`B.
`
`
`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
`
`
`2.
`
`
`
`
`
`i
`
`
`
`

`
`IPR2015-00990; -01093
`
`
`
`Pursuant to 37 C.F.R. 42.64(c), the Trial Practice Guide, 77 Fed. Reg. 157,
`
`48756-73, 48767 (August 14, 2012) and the Scheduling Orders in these IPRs,
`
`Patent Owner NPS Pharmaceuticals Inc. (“NPS”) submits this motion exclude the
`
`Reply Declaration of Anthony Palmieri III, Ex. 1041.
`
`I. INTRODUCTION
`The opinions in the Reply Declaration (Ex. 1041) are inadmissible under
`
`Fed. R. Evid. 702. Dr. Palmieri has shown in his depositions that he is not qualified
`
`to offer expert testimony in protein/peptide formulation science, which is the field
`
`of the ‘886 patent. The opinions expressed in Ex. 1041 should be excluded because
`
`they are not based on sufficient facts or data, they are not the product of reliable
`
`principles and methods, and they are not reliably applied to the facts of this case.
`
`Certain testimony is also inadmissible hearsay and irrelevant speculation
`
`under Fed. R. Evid. 801 and 401. In Ex. 1041, ¶¶ 10-19, Dr. Palmieri purports to
`
`know what was in the mind of the ‘886 inventor, as grounds for disregarding the
`
`challenges the inventor faced. Dr. Palmieri of course has no personal knowledge of
`
`the inventor’s work and no access to her thoughts. His opinions arising from
`
`surmise about the inventor should be excluded. Such testimony is also irrelevant
`
`under Rule 401, because the inventor is not a person of ordinary skill in the art, nor
`
`is a patent required to identify any or all of the problems the invention overcame.
`
`
`28525889v1
`
`1
`
`

`
`IPR2015-00990; -01093
`
`II. LEGAL STANDARD FOR MOTION TO EXCLUDE
`“A party wishing to challenge the admissibility of evidence must object
`
`timely to the evidence at the point it is offered and then preserve the objection by
`
`filing a motion to exclude the evidence.” Trial Practice Guide, 77 Fed. Reg. 48765,
`
`48767 (Aug. 14, 2012) (citing 37 C.F.R. § 42.64). “A motion to exclude evidence
`
`must: (a) Identify where in the record the objection originally was made; (b)
`
`Identify where in the record the evidence sought to be excluded was relied upon by
`
`an opponent; (c) Address objections to exhibits in numerical order; and (d) Explain
`
`each objection. Id.
`
`Expert testimony in an IPR is generally governed by the Federal Rules of
`
`Evidence. 77 Fed. Reg. 157, at 48758. Fed. R. Evid. 702 (“Rule 702”) provides
`
`that a witness must be “qualified as an expert by knowledge, skill, experience,
`
`training, or education.” The testimony must be: (a) helpful specialized knowledge;
`
`(b) “based on sufficient facts or data;” and (c) “the product of reliable principles
`
`and methods;” which in turn are (d) “reliably applied … to the facts of the case.”
`
`Rule 702 is consistent with Daubert v. Merrell Dow Pharmaceuticals, Inc.,
`
`509 U.S. 579, 592-95 (1993), which provides for unreliable testimony to be
`
`excluded. Pertinent factors under Daubert include whether the expert’s theory is
`
`subjective and conclusory, has been subject to peer review and publication, and has
`
`been generally accepted in the scientific community. Another factor is whether the
`
`
`28525889v1
`
`2
`
`

`
`IPR2015-00990; -01093
`
`expert has developed opinions “expressly for purposes of testifying.” Daubert v.
`
`Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1317 (9th Cir. 1995). An
`
`opinion cannot extrapolate to an unfounded conclusion, General Elec. Co. v.
`
`Joiner, 522 U.S. 136, 146 (1997), and cannot ignore other obvious explanations,
`
`Claar v. Burlington N.R.R., 29 F.3d 499, 502-03 (9th Cir. 1994). The expert must
`
`testify from a relevant and reliable discipline, Kumho Tire Co. v. Carmichael, 119
`
`S.Ct. 1167, 1175 (1999), and must use “the same level of intellectual rigor that
`
`characterizes the practice of an expert in the relevant field.” Sheehan v. Daily
`
`Racing Form, Inc., 104 F.3d 940, 942 (7th Cir. 1997).
`
`Hearsay evidence is inadmissible under Rule 801, when a statement, other
`
`than one made by the declarant, is offered in evidence “to prove the truth of the
`
`matter asserted.” Air Land Forwarders, Inc. v. US, 172 F. 3d 1338, 1342 (Fed. Cir.
`
`1999). A “statement” under Rule 801 is defined as “a person’s oral assertion,
`
`written assertion, or nonverbal conduct, if the person intended it as an assertion.”
`
`“Irrelevant evidence is not admissible” under Rule 401 and 402, when the
`
`evidence does not tend “to make a fact more or less probable than it would be
`
`without the evidence” or the fact is not of “consequence in determining the action.”
`
`Fed. R. Evid. 401 and 402; see also Daubert, 509 U.S. at 587
`
`(1993); Magnivision, Inc. v. Bonneau Co., 115 F.3d 956, 961 (Fed. Cir. 1997).
`
`
`28525889v1
`
`3
`
`

`
`IPR2015-00990; -01093
`
`The proponent of the evidence, in this case Petitioner, has the burden of
`
`establishing admissibility by a preponderance of the evidence. See Fed. R. Evid.
`
`104(a); Bourjaily v. United States, 483 U.S. 171 (1987).
`
`III. ARGUMENT
`A.
`Identify Where in the Record the Objection Originally was Made
`Petitioner submitted the Reply Declaration (Ex. 1041) in connection with its
`
`Replies in these IPRs (IPR2015-00990, Paper 42; IPR2015-01093, Paper 40).
`
`Patent Owner objected to this Declaration in both IPRs (IPR2015-00990, Paper 45;
`
`IPR2015-01093, Paper 43).
`
`B.
`
`Identify Where in the Record the Evidence Sought to be Excluded
`was Relied Upon by an Opponent
`
`Petitioner relied upon Ex. 1041 on pages 3-21 of Petitioner’s Replies in
`
`these IPRs (IPR2015-00990, Paper 42; IPR2015-01093, Paper 40).
`
`C. Address Objections to Exhibits in Numerical Order
`Patent Owner objects to a single exhibit – Ex. 1041 – which is addressed
`
`below.
`
`D. Explain Each Objection
`1. The Reply Declaration is Not Based on the Qualified Expertise
`of Dr. Palmieri and is Inadmissible
`
`Dr. Palmieri provided his qualifications as an expert by reference to his prior
`
`declaration. Ex. 1041, ¶¶ 1, 5-7 (citing Ex. 1001, e.g., ¶¶ 4-6). He noted some
`
`editorial positions, his publications, a faculty position in Pharmacy, and his
`
`
`28525889v1
`
`4
`
`

`
`IPR2015-00990; -01093
`
`academic degrees in Pharmaceutics and Pharmacy. He asserted his research
`
`interests and undergraduate teaching experience, including “pharmaceutical patents
`
`and drug release.” Ex. 1001, ¶ 4. In the Reply Declaration he also noted his
`
`retirement to adjunct status at the University of Florida. Ex. 1041, ¶¶ 5-7.
`
`Significantly, the Reply Declaration made a new claim of expertise: “I am
`
`well versed in the area of protein/peptide formulation.” Ex. 1041, ¶ 6. Dr. Palmieri
`
`agreed that a “well-versed” expert is someone who is highly experienced, practiced
`
`or skilled, very knowledgeable, or learned. Ex. 2171, 510:5-511:17.
`
`The involved claims of U.S. Patent 7,056,886 are concerned with stable
`
`formulations of peptides, i.e. “GLP-2 or an analog thereof,” including the
`
`[Gly2]GLP-2 analog of claim 37, known as teduglutide, and used in Patent
`
`Owner’s approved drug product, Gattex®. Ex. 1003; Ex. 1039. Petitioner admits
`
`that relevant and reliable expertise in this case is in the “area of protein/peptide
`
`formulation.” Ex. 1041, ¶ 6. However, Dr. Palmieri’s deposition testimony shows
`
`that he is not at all “well versed” in proteins/peptides, their chemistry, their
`
`formulation, or their stabilization. His “knowledge, skill, experience, training, or
`
`education” does not extend to the matters at hand. Rule 702.
`
`Dr. Palmieri testified that he has never published an article on protein
`
`stabilization, peptide formulation, lyophilization, peptide degradation, glucagon,
`
`GLP-2, or GLP-2 analogs. Ex. 2171, 333:12-334:19, 487:22-498:1. At least two of
`
`
`28525889v1
`
`5
`
`

`
`IPR2015-00990; -01093
`
`his editorial board memberships are with publications that are not recognized peer
`
`review journals. Id. at 337:21-338:11; Ex. 1041, ¶ 7. His one-time duties as a
`
`formulation scientist, many years ago, involved talking with scientists, liaising
`
`with the patent attorneys, obtaining generic names for products, and providing
`
`input on trade names. Ex. 2171, 629:15-630:20. He has not worked on any peptide
`
`formulations or peptide stabilization himself, nor published any papers in this area.
`
`Ex. 2042, 30:12-32:11, 40:2-11. Indeed, he is unable to distinguish between
`
`formulating peptides and formulating any other active pharmaceutical agent. Ex.
`
`2042, 32:4-33:21, 35:13-36:10.
`
`Other evidence that Dr. Palmieri is not a qualified expert includes:
`
`(1) He does not understand optimum pH or how this impacts formulation
`
`stability. Ex. 2171, 453:18-454:8.
`
`(2) He does not understand “quality control” or “batch” processing in drug
`
`manufacturing or how they impact formulation stability. Ex. 2171, 426:13-18.
`
`(3) He does not have knowledge or experience concerning protein
`
`denaturation (Ex. 2042, 310:10-15) or renaturation (Ex. 2042, 311:2-312:4).
`
`(4) Although the ‘886 patent claims stable peptide formulations, he does not
`
`have knowledge, and he did not explore, how peptide drugs degrade, nor did he
`
`consider whether or not degradation pathways and circumventing them are
`
`predictable. Instead, he subjectively concluded that such mechanisms are
`
`
`28525889v1
`
`6
`
`

`
`IPR2015-00990; -01093
`
`irrelevant. Ex. 2042, 179:18-20, 180:8-11, 179:5-16, 181:4-182:3, 182:5-18, 183:6-
`
`14, 185:15-21, 189:7-13, 196:10-197, 197:8-25, 198:4-7, 222:17-223:2, 223:8-
`
`224:19, 230:25-27. Later, he admitted they are important, but he still did not
`
`consider them. Ex. 2171, 478:11-479:8, 570:19-25, 600:20-601:25; see also Reply2
`
`at 2, 16-17; Ex. 1041, ¶¶ 10, 77, 80, 81, 95, 100.
`
`(5) He did not consider basic properties of GLP-2 or its analogs (Ex. 2042,
`
`206:16-22), nor how they degrade, nor how such degradation may compare to
`
`glucagon, which he alleges is the closest prior art. See Ex. 1001, e.g., ¶ 36; Ex.
`
`1041, e.g., ¶ 18; Ex. 2042 74:10-75:9 (re Osterberg), 90:4-17 (re Kornfelt), 190:7-
`
`196:8, 200:16-201:21, 209:12-20, 215:21-222:14, 288:20-25; see also Ex. 2171
`
`618:19-25, 630:21-633:16, 637:24-638:15 (degradation of asparagine, tyrosine,
`
`and methionine), 618:7-24 and 619:9-16 (tertiary structure), 626:3-20, 619:18-
`
`622:11, 626:4-20, 631:9-633:16, 637:21-638:15 (degradation at different positions
`
`in GLP-2 and glucagon).
`
`(6) He did not know and did consider whether stabilizing a protein generally,
`
`or stabilizing the peptides GLP-2 or its analogs, would be predictable or
`
`unpredictable in view of aggregation (Ex. 2042, 112:6-16, 192:20-196:8, 179:18-
`
`2 For convenience, citations to “Reply” herein encompass both IPRs, but refer
`
`specifically to Paper 42 in IPR2015-00990. Paper 40 in IPR2015-01093 is
`
`substantively identical and has different pagination.
`
`
`28525889v1
`
`7
`
`

`
`IPR2015-00990; -01093
`
`183:14, 230:8-234:4); hydrolysis (id. at 181:4-182:3); oxidation (id. at 196:10-
`
`197:25, 202:6-14, 222:4-12); buffer salts (id. at 216:2-19); deamidation (id. at
`
`220:12-223:2); peptide cleavage (id. at 223:21-224:7); Malliard reactions (id. at
`
`225:19-226:5); physical degradation (id. at 238:16-22); or apolar surfaces (id. at
`
`191:3-12); see also Reply at 16-17 and Ex. 1041, ¶¶ 10, 77, 80, 81, 95, 100.
`
`(7) He confused different amino acids and did not know their abbreviations
`
`(Ex. 2171, 602:25-604:6, 622:12-624:22, 632:22-633:4), nor could he determine
`
`the amino acid sequence of [Gly2]GLP-2 (teduglutide) (id. at 605:12-607:5,
`
`611:19-613:13, 617:15-618:5).
`
`Dr. Palmieri also is not equipped to interpret the ‘866 patent or its claims:
`
`(8) He does not know whether the claims encompass reactions with GLP-2
`
`or analogs (Ex. 2171, 315:23-346:5), nor whether the claims require GLP-2 or
`
`analogs to have biological activity (id. at 348:21-349:4; c.f. Ex. 1003, claims 32,
`
`44, 51, 60, 68, 75; Ex. 1041, ¶¶ 49, 50).
`
`(9) He does not know whether the claims encompass mannitol plus sucrose.
`
`Ex. 2171, 498:25-499:9; c.f. Ex. 1003, claims 1, 46, 52, 53, 61, 69.
`
`(10) He does not know whether the claims encompass the [Gly2]GLP-2
`
`analog, despite express claim language. Ex. 2171, 582:3-590:2; see Ex. 1041, ¶ 49;
`
`c.f. Ex. 1003, claims 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 45, 47, 64, 72.
`
`
`28525889v1
`
`8
`
`

`
`IPR2015-00990; -01093
`
`(11) He does not know whether the claims encompass formulations that are
`
`to be injected. Ex. 2921, at 399:15-700:3; c.f. Ex. 1003, claims 65, 73.
`
`(12) He does not know the meaning of “stable,” even in claims with express
`
`stability criteria. Ex. 2171, 370:24-371:7; Ex. 1041, ¶ 9, 53-60, 66, 94, 95, 107; c.f.
`
`Ex. 1003, claim 66.
`
`Dr. Palmieri testified that he would need to consult others in order to
`
`consider the potential degradation pathways for a protein/peptide formulation,
`
`although he did not do so for this case. See Ex. 2042, 196:22-197:6; Ex. 2171,
`
`600:20-601:25, 570:20-25. He could “look up,” but did not know to consider the
`
`stabilization properties and potential problems of claimed components and features
`
`of the ‘886 formulations, such as histidine (Ex. 2042, 63:10-16, 75:20-76:9),
`
`phosphate buffers (Ex. 2042 106:5-10) and lyophilization (Ex. 2042, 83:11-84:8,
`
`164:21-165:10, 236:16-22, 239:21-24). Likewise, he would need to consult others,
`
`but did not do so, to determine whether one could screen for GLP-2 analogs that
`
`bind to the GLP-2 receptor (Ex. 2171, 350:8-15, 351:17-352:14). He would even
`
`need someone to tell him the difference between a protein and a peptide, and
`
`whether GLP-2 in the involved ‘886 claims is a protein or a peptide. Id. at 398:23-
`
`399:6, 527:3-8.
`
`In Ex. 1001, at ¶ 22, Dr. Palmieri described a person of ordinary skill in the
`
`art of the ‘886 invention as having, inter alia, “knowledge of formulating peptide
`
`
`28525889v1
`
`9
`
`

`
`IPR2015-00990; -01093
`
`formulations and of
`
`the clinical application of
`
`therapeutics
`
`in
`
`treating
`
`gastrointestinal disorders.” See also IPR2015-00990, Paper 1 at 21; IPR2015-
`
`01093, Paper 1 at 21; IPR2015-00990, Paper 33 at 3; IPR2015-01093, Paper 31 at
`
`3; Ex. 2048, ¶ 30 (relevant expertise includes protein/peptide formulation science).
`
`However, Dr. Palmieri’s stated credentials did not originally include such
`
`knowledge or expertise. He did claim later that he has a vague familiarity with
`
`“protein/peptide formulation” (Ex. 1041, ¶ 6), but he gave no support for this
`
`claim, beyond the words: “I am well versed.”
`
`The cumulative effect of Dr. Palmieri’s testimony shows that he is very far
`
`from well-versed in the area of protein/peptide formulation; he is not even
`
`conversant with its fundamentals. He repeatedly admitted he would need to look
`
`things up or seek out other experts, even to answer fundamental questions of
`
`protein/peptide formulation science -- but he did not do so for his testimony in this
`
`case. He does not possess the helpful specialized knowledge Rule 702
`
`contemplates, and he did not apply the scientific rigor that he admits would be
`
`required. Sheehan, 104 F.3d at 942. He is not aware of many relevant and material
`
`facts, and he did not apply reliable principles and methods, as Rule 702
`
`contemplates, such as evaluating the impact of protein/peptide degradation on
`
`stabilizing a peptide formulation. Instead, he subjectively dismissed these
`
`obviously relevant considerations, in favor of an unsupported conclusion that they
`
`
`28525889v1
`
`10
`
`

`
`IPR2015-00990; -01093
`
`are categorically irrelevant, which he later retracted. Daubert, 509 U.S. at 592-95;
`
`Claar, 29 F.3d at 502-03.
`
`Dr. Palmieri may have read the ‘866 patent (Ex. 1003) and the Carpenter
`
`Declaration (Ex. 1041, ¶ 2), and he may have read some literature, but he is not
`
`qualified to give reliable expert opinions upon them. His Reply Declaration (Ex.
`
`1041) should be excluded, in its entirety.
`
`2. Paragraphs 10-19 of the Reply Declaration Offer Inadmissible
`Hearsay and Irrelevant Testimony
`
`Dr. Palmieri has testified: “The inventor of the ‘886 patent did not consider
`
`the characteristics of GLP-2 or analogs thereof that Dr. Carpenter discusses at
`
`length as complexities in formulating proteins/peptides.” Ex. 1041, ¶ 10. Similarly,
`
`he states: “from my review of the ‘886 patent specification, I do not see that these
`
`issues were ever emphasized by the inventor in order to provide a sufficient
`
`disclosure.” Id. at ¶ 11; see also id. at ¶¶ 12-16.
`
`Dr. Palmieri admits he has no knowledge of what the ‘886 inventor did or
`
`did not consider when making his invention. He never met the inventor nor had
`
`any discussions with her. Ex. 2171, 347:14-348:10. At best, Dr. Palmieri can only
`
`say, by reading the patent, that it does not set forth all of the obstacles that the
`
`invention overcame. In this regard Dr. Palmieri is no more “expert” than any reader
`
`of the patent. He certainly has no personal knowledge of what the inventors
`
`considered, or not, and his testimony to that effect, as rebuttal to Dr. Carpenter, is
`
`
`28525889v1
`
`11
`
`

`
`IPR2015-00990; -01093
`
`either conspicuously irrelevant, fabricated hearsay, or both. Fed. R. Civ. 401, 801.
`
`See Bone Care Int’l et al. v. Pentech Pharm., Inc., 2010 U.S. Dist. LEXIS 105118,
`
`at *31-32, * 47 (N.D. Ill. 2010) (citing Se-Kure Controls, Inc. v. Diam USA, Inc.,
`
`2009 U.S. Dist. LEXIS 1648, at *2 (N.D. Ill. Jan. 9, 2009) (expert is not mind
`
`reader and may not testify to inventor’s intent). An expert opinion cannot
`
`extrapolate to an unfounded conclusion, as by using impermissible hindsight from
`
`the ‘886 patent to mind-read the inventor, as a dispute-driven theory by which the
`
`unpredictability of stabilizing peptides is ignored. Rule 702; General Elec. Co.,
`
`522 U.S. at 146; Daubert, 509 U.S. at 592-95.
`
`The testimony in Ex. 1041, ¶¶ 10-16 is also irrelevant under Fed. R. Civ.
`
`401, because the predictability of an invention, its obviousness, and the presence or
`
`absence of unexpected results, is seen through the eyes of a “person of ordinary
`
`skill in the art,” not through the eyes of the inventor. The inventor’s knowledge of
`
`obstacles, or lack thereof, is irrelevant. See Pre-AIA 35 U.S.C. § 103
`
`(“Patentability shall not be negatived by the manner in which the invention was
`
`made.”); see also Kimberly-Clark Corp. v. Johnson & Johnson, 745 F. 2d 1437,
`
`1454 (Fed, Cir. 1984) (hypothetical person of ordinary skill is not the inventor).
`
`“Instead of ascertaining what was subjectively obvious to the inventor at the time
`
`of invention, the court must ascertain what would have been objectively obvious to
`
`one of ordinary skill in the art at such time.” Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.
`
`
`28525889v1
`
`12
`
`

`
`IPR2015-00990; -01093
`
`2d 714, 718 (Fed. Cir. 1991). This is something else that Dr. Palmieri did not know.
`
`Ex. 2171, 340:4-341:5, 593:12-20; Reply at 3.
`
`Dr. Palmieri complains that the patent discloses at least some, but not all of
`
`the obstacles identified by Dr. Carpenter. See Ex. 1041, ¶ 12. This is irrelevant. A
`
`patent specification is not required, under 35 U.S.C. § 112 or otherwise, to identify
`
`any one or all of the problems the invention overcame. Contrary to Dr. Palmieri’s
`
`insinuations (Ex. 1041, ¶ 11), the patent specification sets forth and claims stable
`
`formulations of GLP-2 and GLP-2 analogs. The specification need not explain how
`
`or why the invention works, nor catalog the inventor’s difficulties. See Alcon
`
`Research Ltd. v. Barr Laboratories, Inc., 745 F.3d 1180, 1190 (Fed. Cir. 2014);
`
`Exxon Chemical Patents, Inc. v. Lubrizol Corp., 64 F.3d 1553, 1567 (Fed. Cir.
`
`1995) (quoting Diamond Rubber Co. v. Consolidated Rubber Tire Co., 220 U.S.
`
`428, 435-36 (1911) (inventor may not know all forces he brought into operation;
`
`“not necessary that he understand or be able to state the scientific principles
`
`underlying his invention”); Fromson v. Advance Offset Plate, Inc., 720 F.2d 1565,
`
`1570 (Fed. Cir. 1983) (“axiomatic that an inventor need not comprehend the
`
`scientific principles on which … his invention rests”).
`
`To the extent Ex. 1041 at ¶¶ 10-19 (see, e.g. ¶ 11) implies non-enablement
`
`of the ‘866 claims, the testimony is further irrelevant and should be excluded,
`
`
`28525889v1
`
`13
`
`

`
`IPR2015-00990; -01093
`
`because 35 U.S.C. § 112 cannot be grounds for challenging a patent in an IPR. See
`
`35 U.S.C. § 311(b); 35 U.S.C. § 318(a).
`
`For all of the reasons given above, Dr. Palmieri’s opinions in Ex. 1041, ¶¶
`
`10-19 should be excluded from these proceedings.
`
`IV. CONCLUSION
`
`Patent Owner respectfully requests that its MOTION TO EXCLUDE
`
`DECLARATION EVIDENCE OF DR. ANTHONY PALMIERI III be granted.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dated: May 18, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Respectfully submitted,
`
`/Joseph R. Robinson/
`
`Joseph R. Robinson, PTO Reg. No. 33,448
`
` Heather M. Ettinger, PTO Reg. No. 51,658
` Dustin B. Weeks, PTO Reg. No. 67,466
` Attorneys for Patent Owner
`
`
`28525889v1
`
`14
`
`

`
`IPR2015-00990; -01093
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing PATENT
`
`OWNER’S MOTION TO EXCLUDE REPLY DECLARATION OF DR.
`
`ANTHONY PALMIERI III has been on attorney for Petitioner, served via
`
`electronic mail on May 18, 2016, to the following addresses provided by
`
`Petitioner:
`
`Jeffrey D. Blake, Esq.
`jblake@merchantgould.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dated: May 18, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Respectfully submitted,
`
`/Dustin B. Weeks/
`
` Dustin B. Weeks, PTO Reg. No. 67,466
`
`
`
`
`
`28525889v1

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket