UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`
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`
`
`PHARMACOSMOS A/S,
`Petitioner,
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`v.
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`LUITPOLD PHARMACEUTICALS, INC.,
`Patent Owner.
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`_______________
`
`IPR2015-01490; Patent 7,754,702 B2
`____________________________________________________________
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`
`PATENT OWNER
`REPLY TO OPPOSITION TO MOTION TO AMEND
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`4813-5417-9378.7
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`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`
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`
`
`PHARMACOSMOS A/S,
`Petitioner,
`
`v.
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`LUITPOLD PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_______________
`
`IPR2015-01490; Patent 7,754,702 B2
`____________________________________________________________
`
`
`PATENT OWNER
`REPLY TO OPPOSITION TO MOTION TO AMEND
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`4813-5417-9378.7
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`IPR2015-01490
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` Reply to Opposition to Motion to Amend
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`I.
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`II.
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`TABLE OF CONTENTS
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`INTRODUCTION ........................................................................................... 1
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`The Substitute Claims Are Enabled ................................................................ 1
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`A.
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`B.
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`C.
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`D.
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`The Specification Enables Methods of Using VIT-45 .......................... 2
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`Iron Mannitol, Iron Gluconate, And Iron Sorbitol Are Enabled ........... 3
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`“Subject” is Human/ Route of Administration ..................................... 3
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`Iron Core Size ........................................................................................ 5
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`III. The Substitute Claims Are Adequately Described .......................................... 6
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`IV. The Substitute Claims Are Not Indefinite ....................................................... 6
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`V.
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`Prior Art ........................................................................................................... 7
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`A.
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`B.
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`C.
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`D.
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`E.
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`F.
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`Petitioner’s Motivation Arguments Ignore The Claim
`Limitations ............................................................................................. 8
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`The Substitute Claims Are Not Rendered Obvious Over Geisser
`In View Of van Wyck, Funk, Or Groman ............................................. 9
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`Patent Owner Has Adequately Addressed Art Relating To RLS ....... 11
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`Patent Owner Has Distinguished Dextran Related Art ....................... 12
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`Petitioner Misunderstands Beshara ..................................................... 13
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`Patent Owner Appropriately Addressed The German Reference ....... 14
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`VI. CONCLUSION .............................................................................................. 14
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`TABLE OF AUTHORITIES
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`CASES
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`Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 2012 WL2358102 (S.D. Ind.
`2012) ..................................................................................................................... 4
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`In re Buchner, 929 F.2d 660 (Fed. Cir. 1991) ........................................................... 2
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`Nike, Inc. v Adidas AG, 812 F.3d 1326 (Fed. Cir. 2016) .................................... 8, 13
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`Pharmacosmos A/S v. Luitpold Pharmaceuticals Inc., IPR 2015-01493 (PTAB
`January 8, 2016) .................................................................................................... 7
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`Pharmacosmos A/S v. Luitpold Pharmaceuticals Inc., IPR2015-01495 (PTAB
`January 8, 2016). .......................................................................................... 10, 12
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`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) ........................................... 7
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`STATUTES
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`37 C.F.R. § 42.20 (b) ................................................................................................. 1
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`37 C.F.R. § 42.20(a) ................................................................................................... 1
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`81 Fed. Reg. 18754 .................................................................................................... 8
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`REGULATIONS
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`Exhibit No.
`1001
`1002
`1003
`1004
`1005
`1007
`1008
`1009
`1017
`1026
`1047
`1053
`1054
`1055
`1057
`1065
`2005
`2039
`2041
`2045
`2046
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`2049
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`2050
`2054
`2055
`2056
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`EXHIBITS RELIED UPON
`Description
`U.S. Patent No. 7,754,702 (“the ’702 patent”)
`WO 2004/037865 (“Geisser”)
`WO 2004/037865 (English translation) (“Geisser”)
`U.S. Publication No. 2003/0232084 (“Groman”)
`Declaration of Dr. Robert Linhardt
`Prosecution History of the ’702 patent
`U.S. Patent No. 5,624, 668 (“Lawrence”)
`U.S. Publication No. 2004/0180849 (“Helenek”)
`U.S. Patent No. 6,599,498 (“the ’498 patent”)
`Funk et al. Hyperfine Interactions 136:73-95(2001) (“Funk”)
`Marchasin et al. Blood 23(3):354-358(1964) (“Marchasin”)
`Second Corrected Declaration of Dr. Adriana Manzi
`Dr Adriana Manzi Deposition Transcript
`Wang et al. JAMA. 314(19):2062-2068 (2015) (“Wang”)
`Keating Drugs 75:101-127 (2015) (“Keating”)
`Geisser et al. Drug. Red. 41(1):32-37 (1991) (“Geisser 1991”)
`Prosecution History of the ’549 patent
`U.S. Patent No. 6,960,571 to Helenek (“the ’571 patent”)
`Beshara et al. Br J Haematol. 120(5):853-9 (2003). (“Beshara”)
`Bailie et al. Neprol. Dial. Transplant 20:1443-1449 (2005) (“Bailie”)
`NKF-KDOQI (2000) (“Eschbach”)
`van Wyck et al. J. Am Soc Nephrol 15: S91-92, S107-S111
`(2004)(“Van Wyck”)
`U.S. Publication No. 2008/0234226
`U.S. Patent No. 5,624, 668 (“Lawrence”)
`Hamstra et al. JAMA 243:1726-1731(1980) (“Hamstra”)
`Deposition Transcript of Dr. Robert Linhardt
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`2088
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`van Wyck, et al. Nephrol Dial Transplant 19: 561–565(2004)
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`I.
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`INTRODUCTION
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`
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`The Motion deletes a species and adds a limitation from a dependent claim
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`examined and allowed in prosecution. Consistent with the Board’s Order in Paper
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`21, Patent Owner has shown written support for the substitute claims as a whole
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`and patentability over the prior art. Petitioner attacks alleged indefiniteness and
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`non-enablement, essentially a collateral attack on the original claims. Petitioner
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`actually “requests” that the Board cancel original, unchallenged and/or uninstituted
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`claims, Opp. 7, 11, violating the rules that relief must be requested in the form of a
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`motion and that motions require prior authorization. 37 C.F.R. § 42.20(a), (b).
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`Petitioner has no expert testimony supporting its prior art position. Patent
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`Owner satisfied its prima facie burden in the Motion, and the subject matter of the
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`substitute claims has been fully examined previously by the PTO.
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`II. The Substitute Claims Are Enabled
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`None of the rules, Trial Practice Guide, or Board precedential decisions
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`require a motion to amend to show enablement. The Board’s guidance in Paper 21
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`gave no notice that such a requirement existed. It would be unjust for the Board to
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`deny relief on the ground that a motion did not satisfy some secret requirement.
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`Petitioner has not made a prima facie case attacking enablement and Patent Owner
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`demonstrates below that the substitute claims are indeed enabled.
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`A. The Specification Enables Methods of Using VIT-45
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`Petitioner admits the specification teaches a skilled artisan to “generally”
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`make iron carboxymaltose but not “how to make” it so that it could be successfully
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`“used according to the claims.” Opp. 3. As purported support, Petitioner uses Dr.
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`Manzi’s statement that she “doesn’t believe that the [’702] patent describes the
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`specific making of VIT-45.” Opp. 4; Ex. 1054, 61:8-19. Patent Owner disagrees.
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`First, Petitioner does not explain why the specification’s “general” disclosure does
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`not allow a POSITA to make VIT-45 without undue experimentation. The details
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`in the specification allow a POSITA to prepare an iron carboxymaltose complex,
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`including VIT-45, without undue experimentation. Further, the disclosure and the
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`working examples provide sufficient details for a POSITA to determine the
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`immunological properties of the complexes recited in the claimed methods and
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`treat a disease, disorder, or condition as recited in the substitute claims.
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`Second, Petitioner argues inconsistently by alleging that Geisser as a good
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`prior art reference discloses iron carboxymaltose complex and yet alleging that the
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`’702 patent does not enable making iron carboxymaltose complex. Opp. 3. A
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`patent need not teach, and preferably omits, what is already known. In re Buchner,
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`929 F.2d 660, 661 (Fed. Cir. 1991).
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`Petitioner also argues the claims are not enabled due to the specification’s
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`incorrect formula for VIT-45. Opp. 4. But the claims do not recite a formula.
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`B.
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`Iron Mannitol, Iron Gluconate, And Iron Sorbitol Are Enabled
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`Petitioner argues that iron mannitol, iron gluconate, and iron sorbitol are not
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`enabled because the specification does not explain how to make these compounds
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`safe at high single unit doses. Opp. 4-6. That is not the right inquiry. Enablement
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`for those species has already been determined. The substitute claims do not
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`present any new questions that were not already answered during prosecution.
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`Nonetheless, the specification provides methods to determine the safety and
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`efficacy of the claimed species. The examples of the ’702 patent provide methods
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`to determine the toxicity, pharmacokinetics, efficacy, and safety of iron
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`carbohydrate complexes. Ex. 1001, cols. 18-26. A POSITA would understand
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`these methods to be applicable to all the claimed iron carbohydrate complexes.
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`Indeed, in response to a question about the range of tools required for a POSITA to
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`analyze the carbohydrates, Dr. Linhardt testified that “in the context of the ’549
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`patent that we’re discussing, they would need a – only a limited number of tools to
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`do the analysis of those types of structures.” Ex. 2056, 75:2-19. Because the
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`specifications of the ’549 and ’702 patents are substantially identical, the
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`specification enables the claimed methods of the substitute claims with respect to
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`iron mannitol complex, iron gluconate complex, and iron sorbitol complex.
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`C.
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`“Subject” is Human/ Route of Administration
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`Petitioner asserts the claims are not enabled because they are not limited by
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`the species of subject or the route of administration, arguing with no basis that the
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`term “subject” “literally encompass[es] mouse to elephant.” Opp. 6. On the
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`contrary, the specification is clear that the “subject” is “human.” Throughout the
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`specification and in the section entitled “Subject in Need Thereof,” the term
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`“subject” and “patient” are used interchangeably. Ex. 1001, 9:18-10:44. The
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`specification refers to clinical guidelines such as “NKF-K/DOQI, Clinical Practice
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`Guidelines for Anemia of Chronic Kidney Disease (2000)” and “target hemoglobin
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`level of a patient” that are related to requirements for human therapy. Id. at 10:7-
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`29. Indeed, a POSITA would understand that the indications listed in the
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`specification are for human treatment. Ex. 1001, 2:38-64; 5:42-6:2. The
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`specification also notes that “1700 subjects have been treated with an iron
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`carboxymaltose complex (VIT-45) in open label clinical trials (see e.g., Example
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`5)” again equating subject with human. Id. 13:16-24. Cf. Eli Lilly & Co. v. Teva
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`Parenteral Medicines, Inc., 2012 WL2358102 at 7 (S.D. Ind. 2012) (“patient”
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`means a “human undergoing medical treatment”).
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`Where the specification refers to other species (dogs, rats, mice, and rabbits)
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`it is to “pre-clinical” or “nonclinical” toxicity studies. Ex. 1001, 13:5-11, 18:12-
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`14. And during prosecution of the related ’549 patent, an enablement rejection was
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`raised and overcome. Ex. 2004, p. 24-25. Here, Petitioner lacks any witness
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`testimony supporting its argument. Thus, Petitioner has no basis to assert that
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`“subject” is any species. Indeed, Petitioner contradicts its own arguments by
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`noting that the “working examples and prior art dosages … would have relevance
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`to human subjects but relevance to non-human subjects is not explored in the
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`specification.” Opp. 7. And Petitioner’s own Exhibit 1060 indicates that the
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`mouse is a “model” for “safety and efficacy” not that it would be a “subject in need
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`thereof,” as required by the substitute claims. Thus, based on the specification and
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`file history, a POSITA would understand that “subject” only refers to a human.
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`Petitioner also alleges that the claims are not enabled for “any means of
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`administration.” Opp. 6. Petitioner has not made a prima facie case that the
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`specification and state of the art do not allow a POSITA to “administer[]” all the
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`claimed complexes without undue experimentation. Petitioner cites no witness or
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`extrinsic evidence. The specification limits the route to those such that “iron … is
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`released [and] symptoms are treated.” Ex. 1001, 6:48-50. A POSITA could
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`determine – without undue experimentation – whether routes were operative. The
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`identical scope of administration was examined during prosecution.
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`D.
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`Iron Core Size
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`Petitioner alleges that the full range of iron core size is not enabled. Opp. 7-
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`8. This limitation was part of issued claim 30. Thus, substitute claim 58 does not
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`present any new issues of enablement.
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`Petitioner alleges that the lack of a recited minimum value for the iron core
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`size would cover “iron core sizes resulting in acute toxicity from labile free iron,
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`which would not be safe to use at high doses.” Opp. 8. However, Petitioner treats
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`the limitation in isolation, ignoring that the claim still requires that the “iron
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`carbohydrate complex has a substantially non-immunogenic carbohydrate
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`component and substantially no cross reactivity with anti-dextran antibodies.”
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`A POSITA would understand that the methods for testing and administering
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`iron carbohydrate complexes disclosed in the specification are applicable to enable
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`the use of all the claimed species, including those with iron core sizes no greater
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`than about 9 nm. The specification need not demonstrate efficacy for each species,
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`just enable a POSITA to determine it for each claimed species without undue
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`experimentation. The specification does that.
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`III. The Substitute Claims Are Adequately Described
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`In a single sentence lacking any evidentiary support, Petitioner argues that
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`there is no “probative evidence” of possession. Opp. 6. Petitioner is mistaken.
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`Dr. Manzi’s Declaration is probative evidence and so is the specification of the as-
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`filed application. Patent Owner has shown support in the specification for the
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`substitute claims as a whole. Ex. 1053, ¶ 58. Petitioner has no contrary evidence.
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`IV. The Substitute Claims Are Not Indefinite
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`Petitioner alleges indefiniteness because “substantially non-immunogenic
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`carbohydrate component” is not explicitly defined in the specification. Opp. 9.
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`That the specification lacks an explicit definition of the term does not make the
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`term indefinite. Petitioner itself has construed the term. Pet. 13. Patent Owner has
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`construed the term in its Response. POR 6-9. Indeed, in a related proceeding,
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`even the Board has construed the term. Pharmacosmos A/S v. Luitpold
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`Pharmaceuticals Inc., IPR2015-01493, Paper 11, p. 6 (PTAB January 8, 2016).
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`Contrary to Petitioner’s allegation, Opp. 10, there is nothing “improper”
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`about looking outside the specification when consistent with use of the term in the
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`specification, as it is here. Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir.
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`2005) (en banc). Petitioner argues that Patent Owner “arbitrarily” chose one
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`reference over another for the adverse event rate value. Opp. 10. Not so. As Dr.
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`Manzi explained (Ex. 1053, ¶ 21), the choice of reference is based on the incidence
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`of anaphylactoid-type reactions to iron dextran, which has been disparaged and
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`disavowed in the specification. The adverse event rate value of dextran alone
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`would be inconsistent with the specification and a meaningless comparison. Thus,
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`this value is not arbitrary.
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`V.
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`Prior Art
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`Petitioner reiterates art distinguished during prosecution, particularly the art
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`relating to RLS (Ex. 1009 and Ex. 2039) and to iron dextran (e.g., Ex. 1047). Opp.
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`18-24; Ex. 1007, e.g., p. 16-17, 178-191; Ex, 2005, e.g. p. 25-26, 67-70.
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`Petitioner asserts that Patent Owner has failed to consider Petitioner’s
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`interpretation of the prior art of record (unsupported by expert testimony) and art
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`not of record. Opp., e.g. p. 17, 20, 21, 23. In fact, Patent Owner’s Motion
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`provided arguments, analysis, evidence, and expert testimony supporting its
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`contention over the art of record and the art Patent Owner was aware of. Petitioner
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`does not argue that Patent Owner violated its duty of candor in this regard. Thus,
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`Patent Owner has met its prima facie burden. Nike, Inc. v Adidas AG, 812 F.3d
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`1326, 1350-1351 (Fed. Cir. 2016). This, in turn, shifts the burden to Petitioner
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`(MasterImage 3D, Inc. v. RealD Inc., IPR2015-00040, Paper 42, p. 1-3 (PTAB
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`July 15, 2015); 81 Fed. Reg. 18754), a burden which Petitioner fails to meet.
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`A.
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`Petitioner’s Motivation Arguments Ignore The Claim Limitations
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`In opposing Patent Owner’s contention that the threshold for obviousness is
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`high, Petitioner contends that “[w]hether or not a high dose can be given relates to
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`labile iron toxicity, not analphylaxis.” Opp. 11. However, Petitioner overlooks the
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`“substantially non-immunogenic” and “substantially no cross reactivity”
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`limitations. Thus, regardless of Petitioner’s opinion (unsupported by expert
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`testimony) on what general motivations exist in the art, both Dr. Manzi’s expert
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`testimony and the limitations of the substitute claims require consideration of
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`immune effects in relation to dosing. Supra IV; Ex. 1053, ¶¶ 20-26, 58-70, 67-70.
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`Accordingly, the threshold for obviousness here is high.
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`B.
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`The Substitute Claims Are Not Rendered Obvious Over Geisser
`In View Of van Wyck, Funk, Or Groman
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`Petitioner cites van Wyck (Ex. 2049), Funk (Ex. 1026), and/or Groman (Ex.
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`1004; parent patent ’498, Ex. 1017) as motivation to alter the species in Geisser
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`(Ex. 1002; Ex. 1003) to have an iron core diameter of less than 9 nm. Opp. 11-18.
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`New Ex. 2088 adds nothing more to what was already addressed in the Motion.
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`Petitioner alleges that van Wyck motivates one “to favor particles with a
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`larger iron core size” than those on the smaller end of the chart, but omits that the
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`larger core size which van Wyck advocates belongs to iron dextran, a species
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`disparaged in the art and specification due to its known association with
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`anaphylaxis. Opp. 13-14; Ex. Ex. 2049, p. 6. At no point is a less than about 9 nm
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`iron core taught in van Wyck; rather, van Wyck’s teachings point to maximizing
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`core size which it says is inversely proportional to labile iron release. Ex. 2049, p.
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`6. In fact, the core size of iron dextran that van Wyck prefers is 10 nm (Id.),
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`greater than the less than about 9 nm required by the substitute claims. As Dr.
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`Manzi testified, teachings relating to iron dextran could not be reliably
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`extrapolated to other iron carbohydrate species. Ex. 1053, ¶70. Thus, applying
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`iron dextran properties to the species of iron carbohydrate in Geisser would not
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`have been obvious, let alone yield an iron core size of less than about 9 nm.
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`Petitioner gives no reason why a POSITA would combine van Wyck with
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`“iron carbohydrate complexes [aside from those addressed in van Wyck] with
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`favorable ‘labile iron’ properties that happened to be smaller than about 9 nm.”
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`Opp. 15. Petitioner points to no disclosure that Funk and Groman teach anything
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`about the species in Geisser. As Dr. Manzi notes in her analysis of Baile, there is
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`“little consistency within the class of iron carbohydrate complexes.” Ex. 1053, ¶64.
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`Further, Funk points to the dissolution characteristics of iron carbohydrate
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`complexes as ultimately being carbohydrate dependent. Ex. 1026, p. 20-21; Ex.
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`1053, ¶83. Indeed, in a related case, the Board rejected the combination of Geisser
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`and Groman due to the distinctions in structure of the carbohydrate components.
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`Pharmacosmos A/S v. Luitpold Pharmaceuticals Inc., IPR2015-01495, Paper 11, p.
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`17-18 (PTAB January 8, 2016). Thus, the weight of evidence supports Patent
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`Owner’s contention that no motivation exists to combine teachings of different iron
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`carbohydrate complexes absent explicit indications of extrapolatability.
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`Patent Owner has carried its burden of demonstrating patentability by
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`providing arguments, evidence, and expert testimony that there is no motivation to
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`combine the references. Contrary to Petitioner’s position (Opp. 16), there is no
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`further burden to demonstrate criticality. Indeed, van Wyck does not even teach an
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`overlapping range but rather a static point, 10 nm. Ex. 2049, p. 6. Petitioner’s
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`arguments and allegations that Patent Owner could have or should have done more
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`are unsupported by expert testimony. Opp., e.g. p. 14, 16, 17. Thus, they should
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`be given significantly less weight in assessing the substitute claims.
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`C.
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`Patent Owner Has Adequately Addressed Art Relating To RLS
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`Petitioner asserts that Patent Owner does not explain why RLS art is
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`distinguishable from the claims. Opp. 18-20. Well, they explicitly exclude RLS.
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`Petitioner overlooks both the testimony of Dr. Manzi and the prosecution
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`history, both of which evidence the irrelevance of RLS-related art. Dr. Manzi
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`notes that RLS-related dosing described in the art of record is tied to the release
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`rate of intravenous administration of iron dextran solutions – a parameter known as
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`IDI which is unique to RLS dose assessment. Ex. 1053, ¶¶72-73; Ex. 1054, 78:17-
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`81:3. (It appears Petitioner did not appreciate the significance of these statements
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`when Dr. Manzi clarified them in her deposition. Opp. 20) This same argument
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`was presented with respect to Helenek (Ex. 1009) during prosecution and was cited
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`by the Examiner as “persuasive” in granting allowance (Ex. 1007, p. 16-17).
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`Petitioner also fails to acknowledge that the Motion to Amend refers to this
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`same argument to distinguish Helenek, pointing to Ex. 1009, p. 4 ¶[0011], where
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`Helenek notes that “the dosage is high—1000 mg/administration; or about two- to
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`ten-fold more than the usual dose when used to treat other conditions.” Mot. 18.
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`Petitioner’s assertions regarding the RLS art and the opinions of a POSITA
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`are unsupported by expert testimony, while Patent Owner offers reasoning
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`substantiated by Dr. Manzi, as well as an inventor and the Examiner during
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`prosecution, why RLS dosing cannot be cross-applied to non-RLS indications.
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`Thus, Patent Owner’s interpretations should be afforded more weight.
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`Patent Owner has met its burden to demonstrate the substitute claims’
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`patentability over RLS-related art.
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`D.
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`Patent Owner Has Distinguished Dextran Related Art
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`In the IPR of related patent U.S. 8,895,612, the Board agreed that iron
`
`dextran is not a species within the scope of the claims, thus denying institution on
`
`claims challenged based on Marchasin (Ex. 1005). Pharmacosmos A/S v. Luitpold
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`Pharmaceuticals Inc., IPR2015-01495, Paper 11, p. 12-15 (PTAB January 8,
`
`2016). Petitioner attempts to revive this argument, asserting that iron dextran was
`
`not as dangerous as Patent Owner’s evidence suggests. Opp. 20-24. Yet the only
`
`actual evidence provided in support is Wang (Ex. 1055), which Petitioner itself
`
`acknowledges is biased by hindsight. Opp. 23. Petitioner also mentions
`
`polyisomaltose, Opp. 20, inaptly as this species is not in the substitute claims.
`
`The veterinary art cited by Petitioner, Geisser 1991 (Ex. 1065), also relates
`
`to iron dextran use. Petitioner asserts “Patent Owner should have considered
`
`[such] prior veterinary art.” Opp. 21. As noted above, veterinary art is not within
`
`the scope of substitute claims; Petitioner has not demonstrated why such art would
`
`be relevant to the patentability of claims relating to human treatment. Supra II.C.
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`Furthermore, Petitioner misunderstands Patent Owner’s burden, which as noted in
`
`4813-5417-9378.7
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`12
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`IPR2015-01490
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` Reply to Opposition to Motion to Amend
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`Nike is to distinguish “over the prior art of record, and over prior art not of record
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`but known to the patent owner.” 812 F.3d at 1331. In Nike, the Federal Circuit
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`noted that a patent owner’s statement that it had met this burden suffices. Id. at
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`1350-1351. Petitioner does not allege that Patent Owner’s statement here is
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`inadequate or incorrect. Thus, Petitioner bears the burden of proving that this
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`additional art renders the substitute claims unpatentable.
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`Petitioner does not meet this burden. The art relates to an iron dextran
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`(Anaemex®), a species disavowed by the specification and outside the scope of the
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`claims. Ex. 1065, p. 1; Ex. 1053, ¶¶67-68. Furthermore, Geisser 1991 is entirely
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`silent on the immune effects of the administered compound. Thus, Petitioner’s
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`arguments do not provide any basis for concluding Geisser 1991 is relevant to the
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`substitute claims, let alone that Geisser 1991 makes the substitute claims
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`unpatentable by itself or in combination with another reference.
`
`E.
`
`Petitioner Misunderstands Beshara
`
`Petitioner argues that the specification “recognizes that Beshara in fact is a
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`report about VIT-45,” Opp. 24, despite Beshara’s explicit statement that it relates
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`to iron polymaltose (Ex. 2041, p. 1). Contrary to Petitioner’s characterization, the
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`data in the specification is not identical to that of Beshara, but rather differs in
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`duration, patient population, dosing, and iron carbohydrate complex used. Ex.
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`1001, 12:51; 18:31; 18:33-39. Petitioner also truncates Dr. Manzi’s testimony,
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`4813-5417-9378.7
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`13
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`IPR2015-01490
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` Reply to Opposition to Motion to Amend
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`which in context of the deposition relates to the specification of the ’702 patent
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`(not Beshara) describing the properties of VIT-45. Ex. 1054, 66:3 -70:10.
`
`While Petitioner argues that extrinsic evidence from 2015 (Ex. 1057) cites
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`Beshara as teaching iron carboxymaltose, Opp. 24, the basis for this statement in
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`that reference is neither warranted in the reference nor supported by expert
`
`testimony. Indeed, prior investigators in the art at the time the ’702 patent was
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`filed recognized Beshara as relating to iron polymaltose. Ex. 2088, p. 1. Beshara
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`also does not address doses in the scope of the claims or iron core size. Ex. 2041,
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`p. 1-7. Thus, it does not bear on limitations of the substitute claims.
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`F.
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`Patent Owner Appropriately Addressed The German Reference
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`Petitioner raises inventorship on the “possible” impact of non-prior art
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`(Ex.1007, p. 94-117; Ex. 2050). It has no basis in law or fact for its assertion, does
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`not challenge inventorship of the named inventors (who each signed under oath as
`
`an inventor (Ex. 1007, p. 267-268)), and alleges no contribution to conception by
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`any other specific person. Opp. 24-25. Its assertion is so undeveloped it is waived.
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`VI. CONCLUSION
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`Patent Owner urges the Board to grant the Motion to Amend.
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`Respectfully submitted,
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`/George E. Quillin/
`George E. Quillin
`Registration No. 32,792
`Counsel for Patent Owner
`
`
`
`Date: July 19, 2016
`
`
`Michael D. Kaminski
`Registration No. 32,904
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`4813-5417-9378.7
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`14
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`IPR2015-01490
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` Reply to Opposition to Motion to Amend
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of this Patent Owner Reply to
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`Opposition to Motion to Amend is being served on July 19, 2016, by filing it
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`through the PTAB E2E System as well as delivering copies via email to the
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`following counsel for the Petitioner:
`
`
`
`Lisa Kole
`Baker Botts L.L.P.,
`30 Rockefeller Plaza, 45th Floor,
`New York, NY 10112
`E-mail: lisa.kole@bakerbotts.com
`
`Steven Lendaris
`Baker Botts L.L.P.,
`E-mail: steven.lendaris@bakerbotts.com
`
`Paul Ragusa
`Baker Botts L.L.P.,
`E-mail: paul.ragusa@bakerbotts.com
`
`4813-5417-9378.7
`
`
`/George E. Quillin/
`George E. Quillin
`Registration No. 32,792
`Counsel for Patent Owner
`
`Foley & Lardner LLP
`3000 K Street, N.W.
`Suite 600
`Washington, D.C. 20007
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