throbber
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
`
`By:
`
`
`
`
`
`
`
`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 OPPOSITION TO PATENT OWNER’S
`MOTION TO EXCLUDE REPLY DECLARATION
`OF ANTHONY PALMIERI III (EX. 1041)
`
`
`

`
`TABLE OF CONTENTS
`
`
`INTRODUCTION ........................................................................................... 1 
`
`LEGAL STANDARD ..................................................................................... 3 
`
`I. 
`
`II. 
`
`III.  ARGUMENT ................................................................................................... 4 
`
`A. 
`
`B. 
`
`Patent Owner’s Motion Is An Unauthorized Sur-Reply. ...................... 4 
`
`Dr. Palmieri Is Qualified To Provide Expert Testimony. ..................... 5 
`
`1.  Patent Owner’s submission of Observations is a de facto
`concession that the Declaration should not be excluded. ............ 10 
`
`2.  Patent Owner did not comply with 37 C.F.R. 42.64(b)(1)
`when objecting to Dr. Palmieri’s Declaration. ............................ 11 
`
`C. 
`
`Paragraphs 10-19 Of The Palmieri Declaration Should Not Be
`Excluded. ............................................................................................. 12 
`
`1.  Patent Owner Did Not Timely Object to Paragraphs 10-19........ 12 
`
`2.  Paragraphs 10-19 of the Palmieri Reply Declaration are
`relevant and do not constitute hearsay. ....................................... 13 
`
`IV.  CONCLUSION .............................................................................................. 15 
`
`
`
`
`
`i
`
`

`
`I.
`
`INTRODUCTION
`
`Petitioner Coalition for Affordable Drugs II LLC filed its Reply to Patent
`
`Owner’s Response, supported by the reply declaration of its expert Dr. Anthony
`
`Palmieri III, on April 20, 2016. (Paper 40 and Ex. 1041.) Patent Owner is now
`
`worried by the substance of Dr. Palmieri’s reply declaration. Patent Owner’s
`
`solution to this problem is to submit unauthorized sur-reply arguments to the points
`
`raised by Dr. Palmieri under the guise of a motion to exclude. This is plainly
`
`improper. The Board should not credit these thinly-veiled sur-reply arguments
`
`(which lack any merit as bases to exclude), and the Motion should be denied.
`
`The first argument in Patent Owner’s Motion – that Dr. Palmieri is not a
`
`qualified expert – is plainly contradicted by the record. Patent Owner initially
`
`questions Dr. Palmieri’s background. Dr. Palmieri’s qualifications speak for
`
`themselves, including his academic degrees in Pharmaceutics and Pharmacy,
`
`faculty positions, work in the pharmaceutical industry and service on numerous
`
`editorial boards of pharmaceutical publications – all of which are acknowledged by
`
`Patent Owner. Through his experience, Dr. Palmieri is well-versed in ways to
`
`stabilize formulations of pharmaceutical compounds, including those involving
`
`peptides, which is the subject matter of the claims of the ’886 patent.
`
`Patent Owner then turns to “other evidence that Dr. Palmieri is not a
`
`qualified expert,” and lists a number of factors, such as optimum pH and “quality
`
`1
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`

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`control” or batch processing in drug manufacturing, that purportedly should have
`
`been considered in analyzing the obviousness of the claims of the ’886 patent.
`
`Patent Owner does not believe this “other evidence” actually proves Dr. Palmieri is
`
`not qualified; indeed, Patent Owner’s filing of Observations on Dr. Palmieri’s
`
`testimony is a de facto concession that he is qualified. In reality, this “other
`
`evidence” is just an effort to make sur-reply arguments to the substance of Dr.
`
`Palmieri’s reply declaration, and it should be ignored.
`
`The second argument in Patent Owner’s Motion – that Paragraphs 10-19 of
`
`the Palmieri declaration should be excluded – is both untimely and wrong. Patent
`
`Owner’s objections to Paragraphs 10-19 are raised for the first time in this Motion.
`
`This violates the requirement of 37 C.F.R. 42.64(b)(1) that the objection must have
`
`been filed within five business days of the service of the Palmieri declaration.
`
`Moreover, Paragraphs 10-19 are relevant because they explain that alleged
`
`“complexities” in creating the formulations claimed in the ’886 patent that were
`
`identified by Patent Owner’s expert Dr. Carpenter were not discussed anywhere in
`
`the ’886 patent. Dr. Palmieri is simply pointing out an inconsistency – Dr.
`
`Carpenter argues (with no real support) that these complexities are important but
`
`the patent doesn’t mention them. This is relevant information that the Board can
`
`give the weight it thinks is appropriate. Patent Owner responds to this information
`
`2
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`

`
`by insinuating the inventor may have taken these complexities into account even if
`
`they are not identified in the ’886 patent, which is improper sur-reply testimony.
`
`Finally, these paragraphs are not hearsay because they do not contain out of
`
`court statements by the inventor, only a discussion of what is and is not discussed
`
`in the ’886 patent.
`
`Dr. Palmieri is a qualified expert, and the substance in his reply declaration
`
`is relevant and non-hearsay. This Motion should be denied.
`
`
`
`II. LEGAL STANDARD
`
`The Federal Rules of Evidence apply in an IPR proceeding. 37 C.F.R.
`
`§ 42.62. Fed. R. Evid. 702 requires that an expert witness must be “qualified as an
`
`expert by knowledge, skill, experience, or education,” and the testimony must
`
`“help the trier of fact to understand the evidence or to determine a fact in issue.”
`
`The expert’s testimony must also be “based on sufficient facts or data” and be “the
`
`product of reliable principles and methods” and the expert must “reliably appl[y]
`
`the principles and methods to the facts of the case.” Fed. R. Evid. 702.
`
`“So long as the expert’s testimony rests upon ‘good grounds,’ it should be
`
`tested by the adversary process—competing expert testimony and cross-
`
`examination….” In re TMI Litig., 193 F.3d 613, 692 (3rd Cir. 1999) (quoting
`
`Ruiz-Troche v. Pepsi Cola of Puerto Rico Bottling Co., 161 F.3d 77, 85 (1st Cir.
`
`1998)). If the objections to evidence go to the weight of the expert’s testimony
`
`3
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`

`
`rather than its admissibility, the motion to exclude should not be granted. See
`
`Smith & Nephew, Inc. v. Convatec Techs., Inc., IPR2013-00097, Paper 90 at 59.
`
`Fed. R. Evid. 401 states that “[i]rrelevant evidence is not admissible.”
`
`Evidence is relevant, however, if it has a “tendency to make a fact more or less
`
`probable than it would be without the evidence” and “the fact is of consequence in
`
`determining the action.”
`
`Fed. R. Evid. 801 precludes the use of out-of-court hearsay statements for
`
`use of the truth of the matter asserted. A “statement” under Rule 801 is “a person’s
`
`oral assertion, written assertion, or nonverbal conduct, if the person intended it as
`
`an assertion.”
`
`III. ARGUMENT
`
`A.
`
`Patent Owner’s Motion Is An Unauthorized Sur-Reply.
`
`
`As an initial matter, Patent Owner uses this Motion as an unauthorized sur-
`
`reply, and it should be denied on this basis alone. “If Patent Owner wished to
`
`respond to arguments in Petitioner’s Reply, the proper mechanism was to contact
`
`the Board and request permission for a sur-reply.” Chums, Inc. and Croakies, Inc.
`
`v. Cablz, Inc., IPR2014-01240, Paper 32 at 3. Patent Owner did not do this.
`
`The Scheduling Order in this proceeding explicitly provides that “[t]he
`
`patent owner is cautioned that any argument for patentability not raised in the
`
`response will be deemed waived.” (Paper 27, p. 3.) Despite this, Patent Owner
`
`4
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`

`
`uses this Motion as a vehicle to re-argue previous issues and insert new arguments
`
`that should not be addressed without a sur-reply. By way of example, the Motion
`
`re-argues issues such as optimum pH and degradation pathways that Patent Owner
`
`asserted in its Response (compare Patent Owner’s Response, Paper 31, pp. 19-20
`
`and 24, to the Motion, Paper 49, pp. 6-7), and Dr. Palmieri addressed in his reply
`
`declaration (see, e.g., Ex. 1041, ¶¶ 12-16, 54-57 and 64-67). Further, the Motion
`
`raises new arguments such as the insinuation that the inventor may have taken into
`
`account the alleged complexities in formulation design identified by Patent
`
`Owner’s expert Dr. Carpenter, even though the ’886 patent does not discuss them.
`
`(Paper 49, p. 13.) Such attempts to re-argue issues or introduce new arguments in
`
`a motion to exclude are improper, and the Board should not condone them.
`
`B.
`
` Dr. Palmieri Is Qualified To Provide Expert Testimony.
`Putting aside the fact that the Motion functions as a sur-reply, Patent
`
`Owner’s argument that Dr. Palmieri is not qualified as an expert is wrong. (Paper
`
`49, p. 4-11.) Dr. Palmieri is clearly qualified under both Fed. R. Civ. P. 702 and
`
`Daubert v. Merrill Dow Pharms. Inc., 509 U.S. 579 (1993), to provide expert
`
`testimony relating to the ’886 patent.
`
`The ’886 patent is directed to formulations of GLP-2 peptides and analogs
`
`thereof, as the Field of Invention demonstrates:
`
`5
`
`

`
`
`
`(Ex. 1003, 1:5-8.) The claims of the ’886 patent are also plainly directed to
`
`formulations. (Ex. 1003, 12:9-16:53; Ex. 2171, p. 24, l. 2-p. 26, l. 4.)
`
`Dr. Palmieri has thirty-five years of experience in formulation science. He
`
`holds advanced degrees in Pharmaceutics and Pharmacy, has been and is faculty in
`
`the College of Pharmacy at the University of Florida in the Department of
`
`Pharmaceutics,1 worked in the pharmaceutical industry, and sits on the Board of
`
`publications such as the Journal of Chemical and Pharmaceutical Sciences. (Ex.
`
`1001, ¶¶ 4-7; Ex. 1002.) Moreover, Dr. Palmieri stated in his reply declaration that
`
`his experience makes him “well versed in the area of protein/peptide formulation.”
`
`(Ex. 1041, ¶ 6.)
`
`
`
` Patent Owner notably overlooks the fact that Dr. Palmieri was involved in
`
`the formulation of bovine growth hormone at Upjohn Pharmacia. (Ex. 2042, p. 30,
`
`ll. 12-19.) This involvement provides Dr. Palmieri with knowledge of formulating
`
`peptide formulations, as bovine growth hormone is a peptide. Dr. Palmieri does
`
`
`1 While Dr. Palmieri recently retired from his position as a faculty member of the
`
`College of Pharmacy at the University of Florida in the Department of
`
`Pharmaceutics, he remains an adjunct professor of pharmaceutics. (Ex. 1041, ¶ 6.)
`
`6
`
`

`
`not need to have specific experience with glucagon, GLP-2, or GLP-2 analogs in
`
`order to testify about stabilizing formulations containing peptides, as an expert can
`
`provide helpful testimony even where his or her qualifications are not a perfect
`
`match to what is recited in the claims of the patent at issue. B/E Aerospace, Inc. v.
`
`MAG Aerospace Industries, LLC, IPR2014-01511, Paper 104 at 20.
`
`Dr. Palmieri is plainly qualified by “knowledge, skill, experience, training,
`
`or education,” as required by Rule 702. Moreover, his specialized knowledge
`
`allows him to provide opinions based on “sufficient facts or data” which are the
`
`product of “reliable principles and methods” that are “reliably applied…to the
`
`facts” relating to the claimed inventions of the ’886 patent. See Daubert, 509 U.S.
`
`at 592-595. Dr. Palmieri’s qualifications well surpass the standard established by
`
`the Board when it held that an expert need only be “qualified in the pertinent art.”
`
`B/E Aerospace, Paper 104, p. 20.
`
`Having failed to discredit Dr. Palmieri’s qualifications, Patent Owner turns
`
`to purported “other evidence that Dr. Palmieri is not a qualified expert.” (Paper 49,
`
`pp. 6-9.) But these arguments repeatedly mischaracterize Dr. Palmieri’s testimony.
`
`For example, Patent Owner attempted to find some discrepancy with Dr. Palmieri’s
`
`understanding of optimum pH and how it impacts formulation stability. (Id., p. 6.)
`
`However, during his cross-examination, Dr. Palmieri quite plainly addressed this
`
`issue by stating that optimum pH relates to a compound’s degradation profile and
`
`7
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`

`
`also explained that identifying optimum pH is possible through routine
`
`experimentation. (Ex. 2171, p. 480, ll. 11-19.)
`
`Patent Owner argues about Dr. Palmieri’s understanding of “quality control”
`
`or “batch” processing in drug manufacturing or how they impact formulation
`
`stability. (Paper 49, p. 6.) But, once again during his cross-examination, Dr.
`
`Palmieri describes “what quality control testing is” and discusses how “there are
`
`different ways to do quality control testing.” (Ex. 2171, p. 426, ll. 20-25.)
`
`Patent Owner incorrectly claims that Dr. Palmieri was not knowledgeable
`
`about the amino acid sequence of [Gly2]GLP-2 (teduglutide) “nor could he
`
`determine the amino acid sequence of [Gly2]GLP-2.” (Paper 49, p. 8.) That is
`
`wrong. Dr. Palmieri testified he believed [Gly2]GLP-2 has a glycine at the two
`
`position in the peptide, but would want to determine and confirm the specific
`
`sequence by checking a reference just to be sure. (Ex. 2171, p. 607, l. 10-p. 608, l.
`
`4.) There is nothing inappropriate about an expert consulting a scientific reference
`
`to confirm information. To assert that Dr. Palmieri could not determine the amino
`
`acid sequence of a well-known peptide stretches credulity. In fact, Patent Owner’s
`
`expert Dr. Carpenter stated that he looks up information when necessary. (Ex.
`
`1043, p. 237, ll. 21-25.)
`
`Further, during cross-examination, Patent Owner attempted to elicit legal
`
`conclusions from Dr. Palmieri concerning, for example, whether the claims
`
`8
`
`

`
`encompass “reactions with GLP-2 or analogs,” require “GLP-2 or analogs to have
`
`biological activity,” or encompass “mannitol plus sucrose.” (Paper 49, pp. 8-9.)
`
`Dr. Palmieri understood that he was being asked for legal conclusions and instead
`
`offered to provide his understanding as a scientist. For example, regarding
`
`whether the claims of the ’886 patent encompass reactions with GLP-2 or analogs,
`
`Dr. Palmieri specifically addressed the fact that the claims do not include such
`
`reactions, but are instead formulation claims. (Ex. 2171, p. 345, l. 2-p. 347, l. 6.)
`
`On a similar point, regarding whether GLP-2 or analogs have biological activity,
`
`Dr. Palmieri stated in his Opening Declaration that “[a]n ‘analog’ of GLP-2 is
`
`construed to mean a peptide that incorporates one or more amino acid
`
`substitutions, deletions, additions, or modifications into a natural GLP-2 peptide
`
`and retains biological activity (Ex. 1003 at 4:33-36 and 1:30-37).” (Ex. 1001, ¶ 26
`
`(emphasis added).) Regarding whether the claims encompass mannitol plus
`
`sucrose (see Paper 49 at 8), Dr. Palmieri testified that he cannot provide a legal
`
`conclusion, but offered his scientific opinion on the matter. (Ex. 2171, p. 498, l.
`
`25-p. 499, l. 13.)
`
`Patent Owner’s incessant attempts to obtain legal conclusions from Dr.
`
`Palmieri persisted with questioning as to whether the claims encompass
`
`formulations for injection. (Paper 49, p. 9.) Dr. Palmieri addressed this issue
`
`when he testified a formulator would understand the formulations of the ’886
`
`9
`
`

`
`patent claims should be isotonic in order for the drug to be injectable. (Ex. 2171,
`
`p. 445, l. 25-p. 446, l.11.) What is more, Dr. Palmieri evidently understood the
`
`claims encompass injectable formulations as his opening declaration address the
`
`obviousness of claims 65 and 73 with respect to the limitation “further comprising
`
`an injection device for administration” and “wherein the GLP-2 formulation is
`
`administered by injection.” (See Ex. 1001, ¶¶ 46, 158, 163 and 208.)
`
`Finally, Patent Owner incorrectly argues that Dr. Palmieri “does not know
`
`the meaning of ‘stable.’” (Paper 49, p. 9.) To the contrary, Dr. Palmieri’s opinion
`
`is clear that the claims at issue do not require any particular stability limitations,
`
`with the exception of claims 66 and 67, in which the term “stable” is not
`
`specifically defined. (Ex. 1003, 16:15-18; Ex. 1041, ¶¶ 53-60; Ex. 2171, p. 385, ll.
`
`15-23, p. 388, l. 11-p. 389, l. 5.)
`
`In view of the above testimony from Dr. Palmieri, it is clear that the
`
`purported “other evidence’ listed in Patent Owner’s Motion cannot withstand
`
`scrutiny. Dr. Palmieri is qualified as an expert.
`
`1.
`
`Patent Owner’s submission of Observations is a de facto
`concession that the Declaration should not be excluded.
`
`Patent Owner’s decision to file observations on Dr. Palmieri’s cross-
`
`examination testimony further demonstrates that Patent Owner understands Dr.
`
`Palmieri to be qualified as an expert. The Board’s Trial Practice Guide explains
`
`that either observations on cross-examination or a motion to exclude should be
`
`10
`
`

`
`filed. Specifically, it states “[i]n the event that cross-examination occurs after a
`
`party has filed its last substantive paper on an issue, such cross-examination may
`
`result in testimony that should be called to the Board’s attention, but the party does
`
`not believe a motion to exclude the testimony is warranted.” Trial Practice Guide,
`
`pp. 48767-68 (emphasis added). The Trial Practice Guide is clear that when a
`
`party does not believe a motion to exclude testimony is warranted, then a motion
`
`for observations can be filed. Such an either/or procedure has a logic driven basis
`
`given that excluding direct testimony in the form of a declaration but filing
`
`observations on cross-examination would result in an inequitable outcome where
`
`only the party opposing testimony could use it. By filing its Observations, Patent
`
`Owner de facto concedes that Palmieri declaration should not be excluded.
`
`2.
`
`Patent Owner did not comply with 37 C.F.R. 42.64(b)(1) when
`objecting to Dr. Palmieri’s Declaration.
`
`Patent Owner’s argument about Dr. Palmieri’s qualifications also should be
`
`denied because Patent Owner did not raise a proper objection to the declaration.
`
`The Board’s regulations require that, for evidence other than deposition evidence,
`
`any objection “must identify the grounds for the objection with sufficient
`
`particularity to allow correction in the form of supplemental evidence.” 37 C.F.R.
`
`42.64(b)(1). Patent Owner failed to do so.
`
`Patent Owner’s objection stated only the following: “Fed. R. Evid. 702 &
`
`703 – Improper expert testimony; testimony is not reliable; declarants is not
`
`11
`
`

`
`qualified as an expert.” (Paper 43.) This perfunctory statement doesn’t provide
`
`the required notice necessary to understand what the objection was directed to
`
`given that Dr. Palmieri has a distinguished career spanning more than 35 years in
`
`the pharmaceutical industry and academia, and has served on multiple editorial
`
`boards for journals and publications – all of which demonstrate his expertise and
`
`familiarity with the subject matter of the ’886 patent.
`
`Patent Owner’s Motion demonstrates that it was able to provide more
`
`specificity than just objecting to the entire declaration under Rule 702 and 703.
`
`The Motion identifies specific aspects of Dr. Palmieri’s qualifications with which
`
`Patent Owner now takes issue, such as his “adjunct status at the University of
`
`Florida” and Dr. Palmieri’s statement that he is “well versed in the area of
`
`protein/peptide formulation.” (Paper 49, p. 5.) If Patent Owner was relying on this
`
`information as part of its objection to the declaration, it could have said as much,
`
`and given Petitioner the opportunity to supplement. Patent Owner did not do so.
`
`C.
`
`
`
`Paragraphs 10-19 Of The Palmieri Declaration Should Not Be
`Excluded.
`1.
`
`Patent Owner did not timely object to Paragraphs 10-19.
`
`Patent Owner’s Motion attempts strike paragraphs 10-19 of the Palmieri
`
`Declaration under Fed. R. Evid. 401 and 801. (Paper 49, pp. 11-14.) Patent
`
`Owner, however, did not object timely to these paragraphs of Dr. Palmieri’s
`
`declaration. According to 37 C.F.R. 42.64(b)(1), “[o]nce a trial has been instituted,
`
`12
`
`

`
`any objection must be filed within five business days of service of evidence to
`
`which the objection is directed.” In addition, 37 C.F.R. 42.64(c) requires that a
`
`motion to exclude “must identify the objections in the record….” PO did not
`
`object to paragraphs 10-19 on the basis of either hearsay or relevancy within five
`
`business days of service of the Palmieri. (See Paper 43.) The first time these
`
`objections were raised is in this Motion. Having failed to raise timely objections,
`
`the portion of Patent Owner’s Motion seeking to exclude Paragraphs 10-19 should
`
`be stricken.
`
`2.
`
`Paragraphs 10-19 of the Palmieri Declaration are relevant and
`do not constitute hearsay.
`
`Paragraphs 10-19 of the Palmieri declaration are relevant because they point
`
`out inconsistencies between the plain text of the ’886 patent and the opinions
`
`provided by Patent Owner’s expert Dr. Carpenter in this IPR. Dr. Carpenter takes
`
`the position in his declaration submitted with Patent Owner’s Response that there
`
`are certain “complexities” to designing a stable peptide formulation that evidence
`
`non-obviousness of the claims of the ’886 patent. (See, e.g., Ex. 2040, ¶¶ 55 and
`
`88.) Dr. Palmieri replied in his declaration by pointing out that none of those
`
`complexities are discussed in the ’886 patent.
`
`Paragraphs 10-19 of the Palmieri Declaration are based on the assumption
`
`that the claims of the ’886 patent at issue meet the requirements of 35 U.S.C.
`
`13
`
`

`
`§ 112, including enablement.2 “The test of enablement is whether one reasonably
`
`skilled in the art could make or use the invention from the disclosures in the patent
`
`coupled with information known in the art without undue experimentation.”
`
`United States v. Telectronics, Inc., 857 F.2d 778, 785 (Fed. Cir. 1988). Given the
`
`requirements of 35 U.S.C. § 112, any complexities associated with formulating
`
`GLP-2 and analogs that made these peptides allegedly unpredictable should be
`
`been described in the ’886 patent to the extent overcoming them would not been
`
`well within the ordinary skill in the art. (Ex. 1041, ¶ 11.) But the patent says
`
`nothing about them.
`
`This inconsistency between the disclosure in the ’886 patent and the
`
`opinions of Dr. Carpenter is relevant. The Board can decide what weight to give to
`
`this relevant information, but there is no basis to exclude Paragraphs 10-19. See
`
`Mobotix Corp. v. Comcam Int’l, Inc., IPR2015-00093, Paper 22 at 3 (“Similar to a
`
`district court in a bench trial, the Board, sitting as a non-jury tribunal with
`
`administrative expertise, is well-positioned to determine and assign appropriate
`
`weight to evidence presented.”) Patent Owner’s fear of the information in these
`
`paragraphs certainly is not sufficient to ignore them.
`
`2 Paragraphs 10-19 do not challenge the validity of the claims of the ’886 patent
`
`under 35 U.S.C. § 112. Such a challenge is not allowed in an IPR. See 35 U.S.C.
`
`§ 311(b). Rather, Paragraphs 10-19 assume the enablement requirement is met.
`
`14
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`

`
`Further, the information contained in Paragraphs 10-19 of the Palmieri
`
`declaration is not hearsay. Dr. Palmieri’s opinions in those paragraphs are based
`
`on his consideration of a factual issue—the absence of disclosure in the ’886
`
`patent—not any statement from the inventor or the inventor’s personal knowledge
`
`or state of mind. Dr. Palmieri does not claim to have talked with the inventor and
`
`does not purport to say what the inventor was thinking. He simply points out what
`
`was not written in the ’886 patent. That is not hearsay.
`
`Indeed, the only allusion to the inventor’s state of mind comes in Patent
`
`Owner’s Motion itself, where Patent Owner insinuates that the inventor may have
`
`known of Dr. Carpenter’s complexities but chosen not to “catalog the inventor’s
`
`difficulties” in the ’886 patent. (Paper 49, p. 13.) Patent Owner’s sur-reply
`
`argument about what the inventor may have known should be ignored, as it has no
`
`bearing on the hearsay objection.
`
`Paragraphs 10-19 are relevant and do not constitute hearsay, and Patent
`
`Owner’s effort to exclude them should be flatly rejected.
`
`IV. CONCLUSION
`
`For the reasons stated above, the Motion to Exclude (Paper 49) should be
`
`15
`
`denied.
`
`
`
`

`
`Date: May 27, 2016
`
`
`
`
`
`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
`
`16
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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 OPPOSITION TO PATENT OWNER’S MOTION TO
`
`EXCLUDE REPLY DECLARATION OF ANTHONY PALMIERI III (EX. 1041)
`
`has been served on May 27, 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 27, 2016
`
`
`
`Respectfully submitted,
`
`
`
`/s/ Matthew L. Fedowitz
`Matthew L. Fedowitz, Reg. No. 61,386
`MERCHANT & GOULD P.C.
`Attorney for Petitioner
`
`
`
`17

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