Paper No. 51
`Date Filed: July 24, 2017
`
`Filed On Behalf Of:
`
`Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc.
`
`By:
`
`Scott K. Reed
`sreed@fchs.com
`212-218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.,
`Patent Owners.
`________________
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`________________
`
`PATENT OWNERS’ MOTION TO EXCLUDE EVIDENCE
`
`

`

`TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION ...........................................................................................1
`
`ARGUMENT...................................................................................................3
`
`1.
`
`The Supplemental Declaration of Dr. DeLuca (Exh. 1024) and
`Petitioners’ Reply (Paper 40) raise new prima facie arguments
`and should be excluded as untimely, irrelevant, and unfairly
`prejudicial..............................................................................................3
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`g.
`
`Paragraphs 31-36, 40-46, 50-52, 56-60, and 86-89 of
`Exh. 1024 and pages 8-11 and 13-15 of Petitioners’
`Reply ...........................................................................................4
`
`Paragraphs 106-112 of Exh. 1024 and Pages 23-26 of
`Petitioners’ Reply........................................................................5
`
`Paragraphs 25-30, 91-97, 100-102, 104 of Exh. 1024,
`Pages 6-8, 17-26 of Petitioners’ Reply, and Exhs. 1036,
`1037, 1043...................................................................................6
`
`Paragraphs 101-102 of Exh. 1024...............................................8
`
`Paragraphs 76 and 103-112 of Exh. 1024 and Pages 17,
`22-26 of Petitioners’ Reply.........................................................9
`
`Paragraphs 73-76 of Exh. 1024 and Pages 12 and 17 of
`Petitioners’ Reply......................................................................10
`
`Paragraphs 7-24 of Exh. 1024, Pages 2-3 and 27-28 of
`Petitioners’ Reply and Exhs. 1027, 1028, 1030, 1032 and
`1034...........................................................................................10
`
`2.
`
`3.
`
`Many paragraphs of the Declaration (Exh. 1002) and
`Supplemental Declaration (Exh. 1024) of Dr. DeLuca lack
`factual support and should be excluded. .............................................11
`
`The Declaration of Dr. Mark A. Tracy (Exh. 1018) should be
`excluded; sections of Petitioners’ Argument and Expert
`
`i
`
`

`

`Opinions that rely on the Tracy Declaration to establish claim
`limitations should also be excluded. ...................................................12
`
`The evidence not cited in the Petition or in the Petitioners’
`Reply is irrelevant and should be excluded.........................................13
`
`Exhibits 1014 and 1016-1022 are incomplete and in fairness
`should be considered alongside other evidence under F.R.E.
`106. ......................................................................................................14
`
`4.
`
`5.
`
`III. CONCLUSION..............................................................................................15
`
`ii
`
`

`

`TABLE OF AUTHORITIES
`
`Cases
`Genzyme Therapeutic Prods. Ltd. P’ship v. Biomarin Pharms. Inc., 825
`F.3d 1360 (Fed. Cir. 2016) ............................................................................14
`
`In re Omeprazole Patent Litig., 483 F.3d 1364 (Fed. Cir. 2007)..............................4
`
`In re Van Os, 844 F.3d 1359 (Fed. Cir. 2017).........................................................10
`
`InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327 (Fed. Cir.
`2014) ................................................................................................................6
`
`Patent Trial and Appeal Board Cases
`Coal. for Affordable Drugs VII LLC v. Pozen Inc., IPR No. 2015-01680,
`Paper 18 (P.T.A.B. Feb. 11, 2016) ................................................................12
`
`Rules and Statutes
`
`35 U.S.C. § 312................................................................................................ passim
`
`37 C.F.R. § 42.104 ........................................................................................... passim
`
`37 C.F.R. § 42.123 .................................................................................................1, 2
`
`37 C.F.R. § 42.23 .......................................................................................................1
`
`37 C.F.R. § 42.65 ...................................................................................... 2, 3, 11, 12
`
`Other Authorities
`
`F.R.E. 402 ........................................................................................................ passim
`
`F.R.E. 403 ........................................................................................................ passim
`
`F.R.E. 702 ................................................................................................. 2, 3, 11, 12
`
`F.R.E. 703 ....................................................................................................... 2, 3, 11
`
`F.R.E. 802 ....................................................................................................... 2, 3, 11
`
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,767 (Aug. 14, 2012) ...............1
`
`iii
`
`

`

`I.
`
`INTRODUCTION
`
`Patent Owners Alkermes Pharma Ireland LTD and Alkermes Controlled
`
`Therapeutics, Inc., move to exclude the following evidence:
`
`
`
`Petitioners’ Reply (Paper 40). Petitioners’ Reply far exceeds the
`
`proper scope of a reply by going above and beyond responding to arguments made
`
`in the Patent Owners’ Response. 37 C.F.R. § 42.23(b). In addition, significant
`
`portions of Petitioners’ Reply are based on exhibits that were improperly
`
`introduced with the Reply in violation of 37 C.F.R. § 42.123(b). The Board should
`
`not attempt to parse the Reply and should reject it in its entirety. Office Patent
`
`Trial Practice Guide, 77 Fed. Reg. 48,767 (“[A] reply that raises a new issue or
`
`belatedly presents evidence will not be considered and may be returned.”).
`
`
`
`The Supplemental Declaration of Dr. DeLuca (Exh. 1024). Exhibit
`
`1024 constitutes supplemental information that was improperly submitted more
`
`than one month after the date the trial was instituted. 37 C.F.R. § 42.123(b). It is
`
`also rife with new opinions supporting new theories found in Petitioners’ Reply.
`
`
`
`Exhibits 1027, 1028, 1030, 1032, 1034, 1036, 1037, and 1043. These
`
`exhibits were introduced to support new and improper sections of the Petitioners’
`
`Reply and Dr. DeLuca’s Supplemental Declaration.
`
`
`
`At a minimum, all portions of Exh. 1024 and Petitioners’ Reply that
`
`(1) exceed the proper scope of a reply and/or (2) rely on improperly introduced
`
`1
`
`

`

`supplemental evidence should be excluded under 35 U.S.C. § 312(a)(3), 37 C.F.R.
`
`§§ 42.104(b)(5), 42.123(b), and F.R.E. 402 (irrelevant), F.R.E. 403 (unfair
`
`prejudice, confusing, waste of time). This includes, but is not limited to:
`
`i.
`
`Paragraphs 31-36, 40-46, 50-52, 56-60, and 86-89 of Exh. 1024
`
`and pages 8-11 and 13-15 of Petitioners’ Reply (1a). Petitioners
`
`used their reply to redefine the inherency dispute central to their
`
`case—without the slimmest factual support—as taking place
`
`within a newly-created subcategory of CMCs.
`
`ii.
`
`Paragraphs 25-30, 91-97, 100-112 of Exh. 1024 and pages 6-8 and
`
`17-26 of Petitioners’ Reply (1b-1e). Petitioners used their reply as
`
`a chance to do-over their Ground 2 challenge, from changing the
`
`components of the prior art in Ground 2 to be combined, to newly
`
`construing the microparticle and polymeric binder limitations, to
`
`attempting to supply reasons to combine prior art.
`
`
`
`Portions of the Declarations of Dr. DeLuca (Exhs. 1002, 1024) as
`
`lacking proper factual support under 35 U.S.C. § 312(a)(3), 37 C.F.R. § 42.65(a)
`
`(expert testimony must disclose underlying facts and data), 37 C.F.R.
`
`§ 42.104(b)(5), and F.R.E. 802, 703, 702, 403, and 402.
`
`
`
`The Tracy Declaration (Exh. 1018) and arguments and opinions that
`
`rely upon it to establish the inherent nature of the viscosity limitation as
`
`2
`
`

`

`unsupported argument lacking an evidentiary foundation. Petition, 25-26, 39-40;
`
`Exh. 1002, ¶¶ 60, 70; Petitioners’ Reply, 8-10, 13-15, 19, 21-22; and Exh. 1024, ¶¶
`
`31, 63-64, 66, 69, 88. 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.65(a), 42.104(b)(5);
`
`F.R.E. 702, 703, and 802.
`
`
`
`Petitioners’ evidence not cited in the Petition or in the Petitioners’
`
`Reply should be excluded under 35 U.S.C. § 312(a)(3) and 37 C.F.R. §
`
`42.104(b)(5), and as irrelevant under F.R.E. 402 and 403.
`
`
`
`Exhibits 1014 and 1016-1022 are incomplete and should be
`
`considered alongside other evidence under F.R.E. 106. These references, including
`
`the Tracy Declaration (Exh. 1018), must be considered alongside the complete
`
`versions of the original book or file history.
`
`II.
`
`ARGUMENT
`
`1.
`
`The Supplemental Declaration of Dr. DeLuca (Exh. 1024) and
`Petitioners’ Reply (Paper 40) raise new prima facie arguments
`and should be excluded as untimely, irrelevant, and unfairly
`prejudicial.
`
`Petitioners were free to make their prima facie case any way they wished in
`
`their Petition. But that time has passed. By waiting until now to reveal new
`
`theories and modify old ones, Petitioners violate multiple provisions governing
`
`inter partes review, including 35 U.S.C. § 312(a)(3) (mandating that a petition
`
`identify “with particularity” the evidence that supports the challenges), 37 C.F.R.
`
`§ 42.104(b)(5) (requiring a petition to “identify[ ] specific portions of the evidence
`
`3
`
`

`

`that support the challenge”), 37 C.F.R. § 42.123(b) (requiring party seeking to
`
`submit supplemental information more than one month after trial is instituted to
`
`request authorization to file a motion to submit the information), and F.R.E. 402
`
`(lack of relevance). It also precludes Patent Owners from responding properly to
`
`these new arguments, particularly when even Petitioners’ expert recants them.
`
`F.R.E. 403 (unfair prejudice, confusing, waste of time). For these reasons, at least
`
`the following portions of Exh. 1024 and the Petitioners’ Reply should be excluded
`
`from consideration.
`
`a.
`
`Paragraphs 31-36, 40-46, 50-52, 56-60, and 86-89 of Exh.
`1024 and pages 8-11 and 13-15 of Petitioners’ Reply
`
`As the Petitioners admit (Petition at 25, 39) and the Board recognized
`
`(Institution Decision at 9, 23), the claimed viscosity limitation present in every
`
`challenged claim of the ’061 patent is not expressly disclosed in the prior art.
`
`Petitioners must therefore prove that the viscosity limitation is inherent in the
`
`Johnson or Gustafsson vehicles. See In re Omeprazole Patent Litig., 483 F.3d
`
`1364, 1371 (Fed. Cir. 2007) (requiring disclosure of each and every claim
`
`limitation “either explicitly or inherently”).
`
`Petitioners have failed to do so. Petitioners originally claimed that any and
`
`all carboxymethylcellulose (CMC), without qualification as to grade or type of
`
`CMC, is the “viscosity-controlling component,” so a POSA would therefore
`
`4
`
`

`

`“reasonably expect the injection vehicle of [Johnson or Gustafsson]—having 3%
`
`CMC—to have a viscosity . . . within the claimed range.” Petition at 25-26, 40.
`
`In response, Patent Owners put forth evidence demonstrating that the
`
`Johnson and Gustafsson vehicles comprising certain CMCs at 3% concentration
`
`fell well below the claimed viscosity. See generally Exh. 2059; Exh. 2014, ¶¶ 122-
`
`30. Faced with this evidence, Petitioners seek to retroactively alter their inherency
`
`argument to avoid the implications of the testing data by arguing—for the first time
`
`in their Reply—that a 3% CMC solution is still inherently within the claimed
`
`viscosity range, but only for a subcategory of CMCs that Petitioners have invented:
`
`low (but not extra-low or ultra-low) viscosity CMCs, available as of May 25, 2000,
`
`which are also pharmaceutical grade. See, e.g., Petitioners’ Reply, 12-15; Exh.
`
`1024, 31-36, 40-46, 50-52, 56-60, 86-89. Petitioners’ theory should be excluded as
`
`new and prejudicial.
`
`b.
`
`Paragraphs 106-112 of Exh. 1024 and Pages 23-26 of
`Petitioners’ Reply
`
`Petitioners have improperly changed their prima facie argument as to which
`
`components of the Ground 2 references to combine. Petitioners previously only
`
`asserted the combination of the risperidone microparticles of Ramstack and the
`
`injection vehicle of Gustafsson for claims 20-21. Petition at 45-47, 53-54; Exh.
`
`1002 at ¶ 80. On reply, they assert the combination of the risperidone active of
`
`5
`
`

`

`Ramstack with the microparticles and injection vehicle of Gustafsson to arrive at
`
`claims 20-21. Petitioners’ Reply at 23-26; Exh. 1024 at ¶¶ 106-112.
`
`Dr. DeLuca opines that “a POSA could clearly combine the active agent
`
`risperidone of Ramstack with the microparticles and injectable suspension of
`
`Gustafsson with a reasonable expectation of success.” Exh. 1024 at ¶ 112
`
`(emphasis added). But whether a POSA could combine references is legally
`
`irrelevant. The relevant question under 35 U.S.C. § 103 is what a POSA would do.
`
`InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1352 (Fed. Cir.
`
`2014) (“what a skilled artisan could accomplish . . . is not the relevant inquiry”).
`
`Dr. DeLuca confirmed on cross that he sees no reason why a POSA would actually
`
`substitute the BSA in Gustafsson’s microparticles with risperidone from Ramstack.
`
`Exh. 2081 at 211:23-212:19. Petitioners’ theory should, therefore, be excluded as
`
`new and irrelevant, leaving no unpatentability challenge for claims 20-21.
`
`c.
`
`Paragraphs 25-30, 91-97, 100-102, 104 of Exh. 1024, Pages
`6-8, 17-26 of Petitioners’ Reply, and Exhs. 1036, 1037, 1043
`
`Petitioners have also changed their prima facie argument as to how the
`
`microparticle and polymeric binder limitations are satisfied by Gustafsson.
`
`Petitioners previously relied on the PLGA coating of Gustafsson to meet these
`
`limitations as to claims 17-19 and did not identify a polymeric binder for the other
`
`claims. Petition at 10-11, 45-46, 49, 53-54; Exh. 1002 at ¶¶ 78-79. Now, they
`
`assert that the PLGA coating of Gustafsson satisfies the microparticle and
`
`6
`
`

`

`polymeric binder limitations for claims 1-3, 6-9, 12-13, 20-21, and 22-23.
`
`Petitioners’ Reply at 7-8, 19-24; Exh. 1024 at ¶¶ 30, 91, 93-94, 96, 100-102, 104;
`
`Exh. 1036.
`
`Petitioners also try to reconcile the clear definition of microparticle in the
`
`‘061 patent with the fact that PLGA is used as a coating in Gustafsson by asserting
`
`for the first time that the ’061 patent “specification does not require that the
`
`polymeric binder material has any sort of function,” and that the claims of the ’061
`
`patent do not require the polymeric binder to be “for the formation of the
`
`microparticle.” Exh. 1024 ¶ 30; see also Petitioners’ Reply at 7. On cross,
`
`however, Dr. DeLuca admitted that the polymer in the microparticles of the ‘061
`
`patent serves the function of a matrix or binder, and that the active is dispersed or
`
`dissolved in the polymer. Exh. 2081 at 234:10-235:12.
`
`Despite never before mentioning starch, Petitioners also newly argue that the
`
`starch in Gustafsson satisfies the microparticle and polymeric binder limitations of
`
`the claims of the ’061 patent. Petitioners’ Reply at 6-8, 19-21; Exh. 1024 at ¶¶ 25-
`
`30, 91-97; Exhs. 1036, 1037, 1043. Petitioners make this new argument even
`
`though Dr. DeLuca expressly testified at his first deposition that the starch of
`
`Gustafsson’s microparticles was not a polymer. Exh. 2016 at 243:7-12.
`
`In addition, Dr. DeLuca confirmed on cross that he did not mention starch in
`
`his May 2016 declaration, Exh. 2081 at 84:21-85:3, and that Gustafsson does not
`
`7
`
`

`

`identify starch as a polymer, id. at 223:12-17. He also confirmed that he has never
`
`placed risperidone in a starch microparticle and knows of no reference that does.
`
`Id. at 222:13-22.
`
`Petitioners should not be able to overhaul their arguments at this late stage.
`
`The Board should exclude not only the portions of Exhibit 1024 and the Reply
`
`discussing these assertions, but also Exhibits 1036, 1037, and 1043, the improperly
`
`introduced exhibits upon which the Petitioners rely.
`
`d.
`
`Paragraphs 101-102 of Exh. 1024
`
`Petitioners have also added new combinations to their prima facie case.
`
`Petitioners originally claimed that Gustafsson alone met every limitation of claims
`
`17-19. Petition at 10-11, 45-46, 49, 53-54. Now, Dr. DeLuca opines that claims
`
`17-19 are obvious based on two additional combinations: (1) the microparticles of
`
`Ramstack and the injection vehicle of Gustafsson, Exh. 1024 at ¶ 101, and (2) the
`
`combination of the microparticles of WO 90/13780 (Exh. 1043) and the injection
`
`vehicle of Example 6 in Gustafsson. Exh. 1024 at ¶ 102.
`
`Given Petitioners’ former reliance on Gustafsson alone to meet the
`
`limitations of claims 17-19, these new arguments are plainly inappropriate. Dr.
`
`DeLuca admitted on cross that both opinions are new. See Exh. 2081 at 85:25-
`
`86:4, 227:13-19. He also agreed that Gustafsson does not teach taking something
`
`from WO 90/13780 and combining it with something in Gustafsson. Id. at 93:19-
`
`8
`
`

`

`94:3. Finally, neither new combination was cited or relied upon in Petitioners’
`
`Reply and should thus be excluded for the same reasons described in Section 4
`
`infra.
`
`e.
`
`Paragraphs 76 and 103-112 of Exh. 1024 and Pages 17, 22-
`26 of Petitioners’ Reply
`
`Petitioners have also advanced new arguments in both instituted grounds
`
`regarding motivation to combine. In Ground 1, Petitioners newly assert that a
`
`POSA would have combined Johnson and Kino to minimize the difference
`
`between the densities of the particles. Petitioners’ Reply at 17; Exh. 1024 at ¶ 76.
`
`In Ground 2, Petitioners newly argue that a POSA could combine Gustafsson with
`
`Ramstack to meet the limitations of claims 20 and 21 because of the common and
`
`interchangeable components of the two references. Petitioners’ Reply at 22-26;
`
`Exh. 1024 at ¶¶ 103-112. Petitioners made neither argument in their Petition. See
`
`Petition at 26-27, 46-47; Exh. 1002 at ¶¶ 64-66, 79-80.
`
`A motivation to combine references is part of the prima facie case of
`
`obviousness that Petitioners were obligated to present in the Petition. See In re
`
`Van Os, 844 F.3d 1359, 1362 (Fed. Cir. 2017). By seeking to make new
`
`arguments at this stage, Petitioners are evading both fair play and efficient
`
`resolution of the issues in this case. Thus, ¶¶ 76, 103-112 should be excluded under
`
`F.R.E. 403, and the Board should disregard pages 17 and 22-26 of the Petitioners’
`
`Reply, which rely upon these paragraphs.
`
`9
`
`

`

`f.
`
`Paragraphs 73-76 of Exh. 1024 and Pages 12 and 17 of
`Petitioners’ Reply
`
`Claims 4, 5, 10 and 11 of the ’061 patent further limit the injection vehicle to
`
`one comprising a density enhancing agent. Petitioners originally claimed simply
`
`that Kino taught sorbitol as a “filler” to increase density, fulfilling this limitation.
`
`Petition at 27. Petitioners now claim that the same sorbitol, once Kino’s
`
`microspheres are combined with the injection vehicle, will dissolve into the
`
`injection vehicle, incidentally fulfilling the density-enhancing limitations of claims
`
`4, 5, 10 and 11. Exh. 1024 at ¶¶ 73-76. Petitioners should not be given a second
`
`chance to craft a fresh argument to which Patent Owners cannot respond. F.R.E.
`
`403. The Board should exclude ¶¶ 73-76 of Exh. 1024 and disregard pages 12 and
`
`17 of Petitioners’ Reply, which rely upon these paragraphs.
`
`g.
`
`Paragraphs 7-24 of Exh. 1024, Pages 2-3 and 27-28 of
`Petitioners’ Reply and Exhs. 1027, 1028, 1030, 1032 and
`1034
`
`Petitioners originally argued that the claimed viscosity range was limited to
`
`no less than 19.7 cp, based on prior disclosure of an injection vehicle (Decapeptyl)
`
`at 19.7 cp. Petition at 22; Exh. 1002 at ¶ 53. Now, Petitioners argue that
`
`Decapeptyl fulfills the viscosity limitation through the formulation’s margins of
`
`error. Petitioners’ Reply at 2-3, 27-28; Exh. 1024 at ¶ 11. Petitioners also
`
`introduce new art that could have been introduced with the Petition to support their
`
`argument that viscosities within the claimed range were known. Exhs. 1028, 1030,
`
`10
`
`

`

`1032, and 1034. Again, these tactics put Patent Owners in an unfair position and
`
`inhibit fair resolution of this case. F.R.E. 403. Paragraphs 7-24 of Exh. 1024;
`
`pages 2-3 and 27-28 of Petitioners’ Reply; and Exhibits 1027, 1028, 1030, 1032,
`
`and 1034 should be excluded.
`
`2. Many paragraphs of the Declaration (Exh. 1002) and
`Supplemental Declaration (Exh. 1024) of Dr. DeLuca lack factual
`support and should be excluded.
`
`Throughout Dr. DeLuca’s declaration and supplemental declaration, he
`
`offers unsupported or uncited testimony in violation of 35 U.S.C. § 312(a)(3), 37
`
`C.F.R. §§ 42.65(a) and 42.104(b)(5), and F.R.E. 802, 703, 702, 403, and 402.
`
`Indeed, Dr. DeLuca fails to support his assertions on key disputed facts. For
`
`example, when Dr. DeLuca claims in ¶¶ 60, 61, and 70 of his opening declaration
`
`(Exh. 1002) that CMC concentration is the viscosity controlling component—
`
`perhaps the preeminent factual question of this case—he only cites the Handbook
`
`entry for CMC (Exh. 1008 at 78), which says formulators often use CMC for its
`
`“viscosity-increasing properties,” a far cry from “viscosity-controlling
`
`component”.
`
`Dr. DeLuca fails to support his assertions in his supplemental declaration
`
`(Exh. 1024) as well. There, Dr. DeLuca assumes, again without evidence, that a
`
`POSA would have recognized that CMC, as specified in the ’061 patent and in the
`
`prior art, actually means only a subcategory of CMC that Petitioners created for the
`
`11
`
`

`

`first time in their reply. See supra at 5; Exh. 1024, ¶¶ 31-36, 41-45, 56-60. Factual
`
`assertions of such gravity should have a solid grounding in the literature or in the
`
`prior art and certainly must be backed up by more than Dr. DeLuca’s unsupported
`
`statements. See, e.g., Coal. for Affordable Drugs VII LLC v. Pozen Inc., IPR No.
`
`2015-01680, Paper 18 at 15 (P.T.A.B. Feb. 11, 2016) (finding statements by
`
`Petitioner’s expert that “repeat[] the statements presented in the Petition . . .
`
`without citing any evidence itself” unpersuasive).
`
`Under F.R.E. 702, expert testimony must be based on sufficient facts or data,
`
`use reliable methods or principles, and reliably apply those methods or principles
`
`to the facts of the case. These requirements apply to inter partes review. 35
`
`U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.65(a), 42.104(b)(5). Dr. DeLuca often fails to
`
`provide data, methods, or principles to support his conclusions. The above-
`
`mentioned paragraphs in Dr. DeLuca’s declarations should thus be excluded.
`
`3.
`
`The Declaration of Dr. Mark A. Tracy (Exh. 1018) should be
`excluded; sections of Petitioners’ Argument and Expert Opinions
`that rely on the Tracy Declaration to establish claim limitations
`should also be excluded.
`
`At several points, Petitioners reveal that they use the Tracy Declaration as a
`
`de facto prior art reference. Dr. DeLuca characterizes Petitioners’ inherency
`
`argument as “based on the Tracy Declaration” (Exh. 1024, ¶ 31) and uses the
`
`Tracy Declaration alone—not as it interprets any of the prior art references—to
`
`12
`
`

`

`establish that a POSA would have understood CMC to be the viscosity controlling
`
`component of any injection vehicle. Id. at ¶ 63.
`
`Thus, Petitioners originally relied solely on the Tracy Declaration for the
`
`viscosity limitation. After Patent Owners’ Response, Petitioners understood that
`
`they had improperly adopted the assumptions of Dr. Tracy as he applied them to
`
`Kino and attempted to extrapolate to other vehicles without sufficient explanation
`
`or support. Realizing this, Petitioners completely overhauled their argument in the
`
`Reply, improperly adding numerous new arguments. As detailed above, those
`
`additional new arguments are untimely and should be excluded. See supra at 4-5.
`
`The Tracy Declaration is also not prior art, and paragraphs where Petitioners
`
`use it that way—in the Petition, 25-26, 39-40; Exh. 1002, ¶¶ 60, 70; Petitioners’
`
`Reply, 8-10, 13-15, 19, 21-22; and Exh. 1024, ¶¶ 31, 63-64, 66, 69, 88—should be
`
`excluded.
`
`4.
`
`The evidence not cited in the Petition or in the Petitioners’ Reply
`is irrelevant and should be excluded.
`
`Many paragraphs of Dr. DeLuca’s Declaration (Exh. 1002), Supplemental
`
`Declaration (Exh. 1024), and Exhibits 1019-1021 (Select Excerpts from Theory
`
`and Practice of Industrial Pharmacy) go uncited in the Petition and in the
`
`Petitioners’ Reply and hence should be excluded as irrelevant. F.R.E. 402, 403.
`
`Specifically:
`
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`
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`
`
`¶¶ 1-3, 6, 31, 33-42, 45, 53, 72, 77-78, 81, 84-85, 98, 101, 109-112,
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`and 121 of Exh. 1024 were not cited in the Petitioners’ Reply.
`
`¶¶ 1-3, 31, 33, 45-46, and 83-91 of Exh. 1002, and Exhs. 1019, 1020,
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`and 1021 were not cited in either the Petition or the Petitioners’
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`Reply.
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`Since these pieces of evidence are uncited in the Institution Decision as well,
`
`and are thus irrelevant, Patent Owners move to exclude them under 35 U.S.C. §
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`312(a)(3), 37 C.F.R. § 42.104, F.R.E. 402 and 403. See Genzyme Therapeutic
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`Prods. Ltd. P’ship v. Biomarin Pharms. Inc., 825 F.3d 1360, 1368 (Fed. Cir. 2016)
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`(holding that parties should move to exclude references not cited in the institution
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`decision).
`
`5.
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`Exhibits 1014 and 1016-1022 are incomplete and in fairness
`should be considered alongside other evidence under F.R.E. 106.
`
`Several of Petitioners’ exhibits have been produced as excerpts or as only a
`
`portion of a larger document. Specifically:
`
` Exhs. 1014, 1020-1022 are excerpts from books. In fairness, each excerpt
`
`should be considered in the context of the full respective chapter.
`
` Exhs. 1016, 1017, and 1019 are office actions from the prosecution of U.S.
`
`Pat. App. No. 10/259,949; Exh. 1018 is an office action from the prosecution
`
`of U.S. Pat. App. No. 09/577,875. No office action exists outside of the
`
`context of the amendments that come before and the responses that come
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`14
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`after. In fairness, these office actions must be considered in the context of
`
`the entire file history of the respective applications.
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`III. CONCLUSION
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`For the foregoing reasons, the evidence identified herein should be excluded.
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`July 24, 2017
`
`Respectfully submitted,
`
`/Scott Reed/
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`15
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e)(4), I certify that a copy of the foregoing
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`PATENT OWNERS’ RESPONSE was served on July 24, 2017 by causing it to be
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`sent by email to counsel for Petitioner at the following email addresses:
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`wmentlik.ipr@lernerdavid.com
`
`pkochanski@lernerdavid.com
`
`tvanbuskirk@lernerdavid.com
`
`nvaleyko@lernerdavid.com
`
`July 24, 2017
`
`Respectfully submitted,
`
`/Scott Reed/
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`16
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`