UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Case IPR2016—00947
`
`Patent 8,962,685
`
`
`
`and
`
`HARVEST TRADING GROUP, INC.
`
`Petitioner,
`
`V.
`
`VIREO
`
`SYSTEMS,
`
`INC.
`
`UNEMED CORPORATION
`
`
`
`Patent Owner.
`
`PRELIMINARY PATENT OWNER’S RESPONSE
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`
`P.O. Box 1450 Alexandria, VA 22313-1450
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Case IPR2016—00947
`
`Patent 8,962,685
`
`
`
`and
`
`HARVEST TRADING GROUP, INC.
`
`Petitioner,
`
`V.
`
`VIREO
`
`SYSTEMS,
`
`INC.
`
`UNEMED CORPORATION
`
`
`
`Patent Owner.
`
`PRELIMINARY PATENT OWNER’S RESPONSE
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`
`P.O. Box 1450 Alexandria, VA 22313-1450
`
`
`
`
`
`IPR20l6-00947
`
`PAT. NO. 8,962,685
`
`TABLE OF CONTENTS
`
`TABLE OF CONTENTS ......................................................................................... .. i
`
`EXHIBIT LIST ..................
`
`.................................................................................. .. iii
`
`TABLE OF AUTHORITIES ................................................................................... ..v
`
`INTRODUCTION ......................................................................................... .. 1
`
`II.
`
`OVERVIEW OF THE ‘685 PATENT .......................................................... ..4
`
`III. MANDATORY NOTICES ........................................................................... ..6
`
`PETITIONER HAS NOT IDENTIFIED ALL REAL PARTIES IN
`IV.
`INTEREST. ITS PETITION SHOULD BE DENIED. ........................................... ..6
`
`THE BOARD SHOULD EXERCISE ITS DISCRETION AND REJECT
`V.
`PETITIONER’S RELIANCE ON ALMADA AND ZHANG AS BEING
`
`PREVIOUSLY CONSIDERED. ........................................................................... ..l3
`
`THE ‘685 CLAIMS ARE ENTITLED TO A FILING DATE OF AT LEAST
`VI.
`MAY 14, 2004. ...................................................................................................... ..l6
`
`A.
`
`Burden of Persuasion Remains on Petitioner and Petitioner Failed to Meet
`
`Its Burden. l9
`
`B.
`
`The ‘641 Patent Provides Adequate Written Description for Priority. ....... ..21
`
`VII. CLAIM CONSTRUCTION ........................................................................ ..25
`
`A.
`
`B.
`
`C.
`
`Legal Standard ............................................................................................. ..25
`
`Level of Skill in the Art ............................................................................... ..25
`
`Construction of Individual Claim Terms ..................................................... ..25
`
`VIII. RESPONSE TO IDENTIFIED GROUNDS ............................................... ..31
`
`
`
`IPR20l6-00947
`
`PAT. NO. 8,962,685
`
`A.
`
`Almada Neither Anticipates Nor Renders Obvious Claims 1-20 of the ‘685
`
`Patent. 35
`
`Because Petitioner Cannot Carry Its Burden of Persuasion as to the ‘685
`B.
`Patent’s Right of Priority, Zhang and the CON-CRETTM Website Are Not Prior
`Art.
`43
`
`C.
`Petitioner Has Not Provided Sufficient Evidence to Prove the Public
`Accessibility of the CON-CRETTM Website. ........................................................ ..44
`
`CON—CRETTM Website Neither Anticipates Nor Renders Obvious Certain
`D.
`Claims of the ‘685 Patent....................................................................................... ..48
`
`E.
`
`Almada Cannot Be Combined With CON—CRETTM Website Because CON-
`
`CRETTM Website Is Not Prior Art, and The Combination Does Not Render Certain
`Claims Obvious ...................................................................................................... ..52
`
`The Combination Almada in View of Zhang Does Not Render Obvious
`F.
`Claims 1-20 of the ‘685 Patent. ............................................................................. ..55
`
`IX.
`
`CONCLUSION ............................................................................................ ..60
`
`
`
`IPR2016—00947
`PAT. NO. 8,962,685
`
`EXHIBIT LIST
`
`EXHIBIT
`
`DOCUMENT
`
`Declaration of Mark Faulkner
`
`Vireo Systems, Inc. v. HTG Ventures, LLC et al., Case
`No. SUCV2015—0l875BLS2, “Verified Complaint
`and Jury Demand” (Mass. Sup. Ct. June 22, 2015)
`
`Vireo Systems, Inc. v. HTG Ventures, LLC et al., Case
`No. SUCV2015—01875BLS2, “Answer to Verified
`Complaint and Jury Demand” (Mass. Sup. Ct. Oct. 8,
`2015)
`
`Harvest Trading Group, Inc., Annual Report, Filing
`No. 201659184260 at Massachusetts Secretary of the
`Commonwealth, Corporations Division (Jan.
`12,
`2016)
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`
`
`UNeMed Corp. et al. v. Pr0Mera Health, LLC, et al.,
`Case No. 8:15-cv-00l35—JFB-TDT, “Disclosure of
`Corporate Affiliations,
`Financial
`Interest,
`and
`Business Entity Citizenship” (D. Neb. June 10, 2015)
`
`ProMera Health, LLC, Annual Report, Filing No.
`201663337740 at Massachusetts Secretary of the
`Commonwealth, Corporations Division (Feb. 4, 2016)
`
`Harvest Trading Group Technologies, Inc., Annual
`Report, Filing No. 201659199020 at Massachusetts
`Secretary of
`the Commonwealth, Corporations
`Division (Jan. 12, 2016)
`
`Application No. 13/740,909 Prosecution History
`
`U.S. Pat. No. 7,608,641
`
`Declaration of Alekha K. Dash, R.Ph. Ph.D.
`
`iii
`
`
`
`IPR2016—00947
`
`PAT. NO. 8,962,685
`
`Curriculum Vitae of Alekha K. Dash
`
`Declaration of Jason Wiggers
`
`Declaration of Samir A. Saleh
`
`The American Heritage Dictionary of the English
`Language (3d ed. 1992)
`
`
`
`Chambers Dictionary of Science & Technology (2007)
`T] The Merck Index (8”‘ ed. 1968)
`
`Remington: The Science and Practice of Pharmacy,
`Vol. 1 (19th ed. 1995)
`
`
`
`
`
`Grant, D.J.W. and Brittain H.G., “Solubility of
`Pharmaceutical Solids,” in Physical Characterization
`
`[ofPharmaceutical Solids (1995) (ed. Brittain, H.G.)
`
`MP
`“Creatinine,”
`http://wWw.mpbio.com/detailed
`_info .php ?family_key=0215 39 16&country=223 (last
`accessed July 31, 2016)
`
`Biomedicals,
`
`Krstulovic, A.M. & C.R. Lee, “Defining drug purity
`through chromatographic and related methods: current
`status and perspectives,” J. Chromatography B 689
`(1997), 137-153
`
`
`
`iv
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`
`
`TABLE OF AUTHORITIES
`
`IPR2016-00947
`
`PAT. NO. 8,962,685
`
`Appellate Court Cases
`
`KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007)
`
`Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc)
`
`Cont’l Can. Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264 (Fed. Cir. 1991)
`
`Corning Glass Works v. Sumitomo Electric U.S.A., 868 F.2d 1251 (Fed. Cir. 1989)
`
`Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349 (Fed. Cir. 2012)
`
`Elan Pharms., Inc. v. May Found. For Med. Educ. & Research, 346 F.3d 1051 (Fed.
`Cir. 2003)
`
`Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955 (Fed. Cir. 2001)
`
`Gonzalez v. Banco Cent. Corp., 27 F.3d 751 (1st Cir. 1994)
`
`Hyatt v. Boone, 146 F.3d 1348 (Fed. Cir. 1998)
`
`In re Clay, 966 F.2d 656 (Fed. Cir. 1992)
`
`In re Edwards, 568 F.2d 1349 (CCPA 1978)
`
`In re Kahn, 441 F.3d 977, (Fed. Cir. 2006)
`
`In re Kratz, 592 F.2d 1169 (CCPA 1979)
`
`In re Robertson, 169 F.3d 743 (Fed. Cir. 1999)
`
`Kennecott Corp. v. Kyocera Intern., 835 F.2d 1419 (Fed. Cir. 1987)
`
`Kyocera Wireless Corp. v. ITC, 545 F.3d 1340 (Fed. Cir. 2008)
`
`Loctite Corp. v. Ultraseal Ltd., 781 F.2d 861 (Fed. Cir. 1985)
`
`Power0asis, Inc. v. T-MOBILE USA, Inc., 522 F.3d 1299 (Fed. Cir. 2008)
`
`V
`
`
`
`IPR2016-00947
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`PAT. NO. 8,962,685
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`Nobelpharma AB v. Implant Innovations, 141 F.3d 1059 (Fed. Cir. 1998)
`
`Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316 (Fed. Cir. 2008)
`
`Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325 (Fed. Cir. 2010)
`
`Trintec Indus, Inc. v. Top-U.S.A. Corp., 295 F.3d 1292 (Fed. Cir. 2002)
`
`U.S. v. Jackson, 208 F.3d 633 (7th Cir. 2000)
`
`Wang Labs, Inc. v. Toshiba Corp., 993 F.2d 858 (Fed. Cir. 1993)
`
`Wyers v. Master Lock Co., 616 F.3d 1231 (Fed. Cir. 2010)
`
`District Court Cases
`
`In re Homestore. com, Inc. Sec. Litig., 347 F. Supp. 2d 769 (C.D. Cal. 2004)
`
`Decisions of the Patent Trial and Appeal Board
`
`Amazon.com, Inc. v. Appistry, Inc., IPR2015-00480, Decision Denying Institution
`of Inter Partes Review (P.T.A.B. July 13, 2015) (Paper 18) (nonprecedential)
`
`EMC Corp. v. Personalweb Techs., LLC, IPR2013-00084 (P.T.A.B. May 15, 2014)
`(Paper 64) (nonprecedential)
`
`Galderma S.A.
`Institution of
`
`IPR2014-01422, Decision Denying
`v. Allegran Indus, SAS,
`Inter Partes Review (P.T.A.B. Mar.
`5, 2015)
`(Paper
`14)
`
`(nonprecedential)
`
`Neste Oil Oyj v. Reg Synthetic Fuels, LLC, IPR2013—00578, Decision on Patent
`Owner’s Motion to Exclude Evidence,
`(P.T.A.B. Mar. 12, 2015)
`(Paper 53)
`
`(nonprecedential)
`
`Zoll Lifecor Corp. v. Philips Elecs. N. Am. Corp., IPR2013-00607, Decision
`Denying Institution of Inter Partes Review (P.T.A.B. Mar. 20, 2014) (Paper 13)
`(nonprecedential)
`
`Vi
`
`
`
`
`
`IPR2016—O0947
`
`PAT. NO. 8,962,685
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`Statutes
`
`35 U.S.C. §112
`
`35 U.S.C. § 120
`
`35 U.S.C. §311(b)
`
`35 U.S.C. § 312(a)(2)
`
`35 U.S.C. § 325(d)
`
`USPTO Rules & Regulations
`
`37 C.F.R. § 42.8(b)(1)
`
`37 C.F.R. § 42.62(a)
`
`37 C.F.R. § 42.104
`
`37 C.F.R. §42.108(c)
`
`Other Authority
`
`MPEP 2121.01
`
`vii
`
`
`
`
`
`IPR2016-00947
`
`PAT. NO. 8,962,685
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`Patent Owner Vireo Systems, Inc. (“Owner” or “Vireo”), acting to the
`
`exclusion of co-owner Board of Regents of the University of Nebraska (Paper 6),
`
`hereby files this preliminary response to the petition of Petitioner Harvest Trading
`
`Group, Inc. (“Petitioner”) to institute an inter partes review (“IPR”) proceeding as
`
`to claims 1-20 of U.S. Patent No. 8,962,685 (the “‘685 Patent”). For at least the
`
`reasons set forth below, the Petition should be denied in its entirety, and no inter
`
`partes review instituted.
`
`I.
`
`INTRODUCTION
`
`This Petition arises out of a failed business relationship between Petitioner’s
`
`affiliate, ProMera Health, LLC, and Owner. Under a Product Development and
`
`Manufacturing Agreement (“PDMA”), Owner was responsible for manufacturing a
`
`creatine hydrochloride nutritional supplement under the ‘685 Patent and U.S. Patent
`
`No. 8,354,450 (the ‘450 Patent), branded under the name Con—CRETTM, and
`
`ProMera was to market and distribute it. (EX. 2001, ‘H 5). While the PDMA was in
`
`place, ProMera sold the CON—CRETTM nutritional supplements using the creatine
`
`hydrochloride supplied by Vireo to its managers’ affiliate, Petitioner. (Ex. 2001, ‘][
`
`14). ProMera or Petitioner, under the ProMera brand, advertised the Con-CRETTM
`
`products as “patented” and its packaging included a reference to the ‘450 and ‘685
`
`Patents. (Ex. 2001, ‘H 14). While the PDMA was in place, James P. Lewis, John T.
`
`
`
`IPR2016-00947
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`PAT. NO. 8,962,685
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`Lewis, and Tim Kensinger (the principals of ProMera and Petitioner) were provided
`
`copies of the pending patent applications, communications to and from the United
`
`States Patent and Trademark Office (“USPTO”), and provided input on the
`
`prosecution of the application.
`
`(Ex. 2001,
`
`‘H 15). In fact, ProMera was even
`
`responsible for payment of, and did in fact pay, the attorneys’ fees associated with
`
`the prosecution of the ‘450 Patent and ‘685 Patent. (Ex. 2001, ‘I[ 15).
`
`As a result of Petitioner’s and its owners’ misconduct, Vireo terminated the
`
`PDMA on February 5, 2015. (Ex. 2001, ‘J1 16). After termination, Petitioner and its
`
`affiliates continued to sell
`
`the creatine hydrochloride-based CON—CRETTM
`
`nutritional supplement using an alternative manufacturer of creatine hydrochloride.
`
`(Ex. 2001, ‘]I 16). Petitioner continued and continues to advertise the unpatented
`
`creatine hydrochloride as CON-CRETTM, which had been branded as a patented
`
`product. (EX. 2001,91 16).
`
`Petitioner and ProMera sued Owner seeking a declaratory judgment to
`
`invalidate the ‘450 and ‘685 Patents in the United States District Court
`
`in
`
`Massachusetts (“Massachusetts Patent Litigation”). (Ex. 2001, ‘I[ 17). Owner sued
`
`Petitioner and ProMera for infringement of the ‘450 and ‘685 Patents (among other
`
`claims) in the United States District Court of Nebraska on April 22, 2015. (Ex. 2001,
`
`‘I[ 17). One year later, on April 22, 2016, Petitioner filed this IPR seeking to challenge
`
`2
`
`
`
`IPR2016-00947
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`PAT. NO. 8,962,685
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`the very patent they so actively relied upon and promoted under its prior business
`
`relationship with Owner. (Ex. 2001, ‘][‘jl[ 14, 17).
`
`Petitioner bears the burden to demonstrate a reasonable likelihood that at least
`
`one of the challenged claims is unpatentable. 37 C.F.R. §42.108(c). Petitioner has
`
`failed to meet that burden for a number of reasons.
`
`First, Petitioner has failed to identify the real parties in interest, and the
`
`Petition should be denied in its entirety on that basis. Second, the Board should
`
`exercise its discretion under 35 U.S.C. § 325(d) and reject the petition because two
`
`of the three references relied upon by Petitioner were considered by the USPTO in
`
`substantially related matters. Third, the ‘685 Patent is entitled to a priority date
`
`earlier than two of the three references Petitioner relies upon, and thus do not
`
`constitute prior art. Fourth, Petitioner has failed to demonstrate one of the references
`
`relied upon constitutes a publicly available printed publication. Without even
`
`considering the substance of the alleged prior art relied upon by Petitioner, the
`
`Petition should be denied.
`
`The Petition should also be denied because the three (3) references relied
`
`upon——Almada (Ex. 1116), Zhang (Ex. 1114), and CON-CRET Website (Ex.
`
`1115)—simply do not present a prima facie case of anticipation or obviousness
`
`against the claims of the ‘685 Patent. The Petitioner recognizes that the references
`
`
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`IPR20l6-00947
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`PAT. NO. 8,962,685
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`do not disclose or teach specific claim limitations, for example,
`
`the solubility
`
`requirements. Petitioner seeks to bridge the divide with conclusory statements,
`
`flawed logic, and incorrect science. At its core, Petitioner seeks to establish certain
`
`inherent characteristics in its prior art references where such inherency does not
`
`exist. Owner respectfully requests that the Petition be denied.
`
`II.
`
`OVERVIEW OF THE ‘685 PATENT
`
`Creatine is a naturally occurring nitrogenous compound found in the skeletal
`
`muscles of vertebrates that plays an important role in protein metabolism and other
`
`bio—chernical
`
`functions.
`
`(Ex.
`
`1101 at 1:31-34).
`
`In particular, creatine and
`
`phosphocreatine are important in the anaerobic production of adenosine triphosphate
`
`(“ATP”) during short and intensive physical exertions. Id. at 1:37-39.
`
`During muscle contraction,
`
`there is an increase in the amount of
`
`phosphocreatine, and consequently, ATP.
`
`Id.
`
`at 1:39-42. The amount of
`
`phosphocreatine in the muscle cell determines the amount of time it takes for a
`
`muscle to recover from activity. Id. at 1:42-44. Creatine, however, has the ability to
`
`increase the concentration of phosphocreatine and ATP to meet increased energy
`
`demands and physical exertion. Id. at 1:45-47.
`
`Increasing creatine levels in muscles through dietary supplementation has
`
`proven ‘effective at enhancing athletic performance, increasing muscle workload,
`
`
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`lPR2()16-00947
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`PAT. NO. 8,962,685
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`and shortening muscle recovery time. Id. at 1:54-57. However, prior to the invention
`
`in the ‘685 patent family, the standard creatine salt of choice for commercial creatine
`
`supplement formulations was creatine monohydrate.
`
`Id. at 1:61-63. Creatine
`
`supplements containing creatine monohydrate were not ideal dietary supplements
`
`due to their low aqueous solubility. Id. at 1:64-66. As such, relatively large doses of
`
`creatine monohydrate needed to be consumed with large amounts of fluid for
`
`effective use. Id. at 1:66-68. Consequently, people often experienced excessive
`
`water retention, cramps, and significant gastrointestinal problems due to the large
`
`doses. Id. at 2:1-3.
`
`Accordingly, one embodiment of the invention described in the ‘685 Patent
`
`addresses the need for a more improved form of creatine with improved solubility
`
`that can be consumed in smaller dosage forms. The ‘685 patent relates to novel
`
`creatine supplement formulations that include creatine hydrochloride salt (“Crt-
`
`HCl”). Id. at 2:21-22. These novel supplement formulations have improved aqueous
`
`solubility over previous forms of creatine. Id. at 3:38-41. In particular, the creatine
`
`supplement formulations disclosed by the ‘685 patent have an increased aqueous
`
`solubility of at least an order of magnitude over that of creatine monohydrate. Id. at
`
`1:23-27. Due to the enhanced properties of Crt-HCl, the effective dose is also much
`
`less than other forms of creatine. Id. at 6:26-27. Thus, the improvements in the
`
`
`
`solubility of Crt—HCl reduce or essentially eliminate the negative side effects
`
`typically associated with previous forms of creatine. Id. at 3:55-57.
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`IPR20l6-00947
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`PAT. NO. 8,962,685
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`III. MANDATORY NOTICES
`
`Owner hereby incorporates by reference the information disclosed in the
`
`Notice filed on May 17, 2016 (Paper 5).
`
`IV.
`
`PETITIONER HAS NOT IDENTIFIED ALL REAL PARTIES IN
`INTEREST. ITS PETITION SHOULD BE DENIED.
`
`The Board should deny the Petition because Petitioner failed to identify at
`
`least one real party in interest. By statute, a petitioner must name all real parties in
`
`interest, 35 U.S.C. § 3l2(a)(2), including any third parties that have an actual
`
`measure of control or opportunity to control the proceedings before the Board. Here,
`
`despite naming as real parties in interest two of the three individuals who control
`
`Petitioner and related entities, Petitioner omits a third individual, Timothy S.
`
`Kensinger (“Kensinger”), who has an equal right to—and does in fact——control those
`
`entities. The Petition therefore fails to meet
`
`the statutory requirements for
`
`consideration by the Board.
`
`The Petition for inter partes review “may be considered only if” the Petitioner
`
`satisfied its burden of “identif[ying] all real parties in interest.” Id.; see also 37
`
`6
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`
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`IPR20l6—00947
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`PAT. NO. 8,962,685
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`C.F.R. §§ 42.104, 42.8(b)(1). This requirement is a “threshold issue,” Galderma S.A.
`
`V. Allegran Irzdus., SAS, IPR2014-01422, Decision Denying Institution of Inter
`
`Partes Review, at *5 (P.T.A.B. Mar. 5, 2015) (Paper 14) (internal quotation marks
`
`and citation omitted) (nonprecedential), and “the Board may not consider a petition
`
`that fails to meet th[is] statutory requirement[],” Zoll Lifecor Corp. v. Philips Elecs.
`
`N. Am. Corp., IPR2013-00607, Decision Denying Institution of Inter Partes Review,
`
`at *8 (P.T.A.B. Mar. 20, 2014) (Paper 13) (nonprecedential). Although the Board
`
`ordinarily presumes a petitioner accurately listed the real parties in interest, the
`
`patent owner must only provide “sufficient rebuttal evidence that reasonably brings
`
`into question the accuracy of a petitioner’s identification of the real parties—in—
`
`interest.” Galderma, Paper 14, at *6—7. When the patent owner presents sufficient
`
`rebuttal evidence,
`
`the burden shifts back to petitioner “to establish that it has
`
`complied with the statutory requirement to identify all the real parties-in—interest.”
`
`Id. at *7.
`
`In general, a real party in interest is a “party that desires review of the patent,”
`
`whether that be “the petitioner itself” or the “parties at whose behest the petition has
`
`been filed.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48759 (Aug.
`
`14, 2012). This question is “highly fact-dependent” and a variety of factors will
`
`inform the determination, the most common of which “is whether the non—party
`
`
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`IPR2016—00947
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`PAT. NO. 8,962,685
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`exercised or could have exercised control over a party’s participation in a
`
`proceeding.” Galderma, Paper 14, at *7 (quoting 77 Fed. Reg. at 48,759, 48,761).
`
`Under the control standard, a third party qualifies as a real party in interest
`
`when “the non-party has the actual measure of control or opportunity to control that
`
`might reasonably be expected between two formal parties.” Id. at *7. In other words,
`
`“[i]f a nonparty can influence a petitioner’s actions in a proceeding before the Board,
`
`to the degree that would be expected from a formal copetitioner, that nonparty should
`
`be considered a real party-in—interest.” Amazon. com, Inc. v. Appistry, Inc., IPR20l5-
`
`00480, Decision Denying Institution of Inter Partes Review, at *4 (P.T.A.B. July
`
`13, 2015) (Paper 18) (internal quotation marks, alteration, and citation omitted)
`
`(nonprecedential). The party’s control may be “overt or covert, and the evidence of
`
`it may be direct or circumstantial—so long as the evidence as a whole shows that
`
`the nonparty possessed effective control over a party’s conduct .
`
`.
`
`. as measured from
`
`a practical, as opposed to a purely theoretical, standpoint.” Galderma, Paper 14, at
`
`*7 (quoting Gonzalez v. Banco Cent. Corp., 27 F.3d 751, 759 (1st Cir. 1994))
`
`(alteration in original). Factors relevant to control include the “existence of a
`
`financially controlling interest in the petitioner[,] .
`
`.
`
`. the non—party’s relationship
`
`with the petitioner[,] .
`
`.
`
`. and the nature of the entity filing the petition.” Zoll, Paper
`
`13, at *9.
`
`
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`IPR20l6-00947
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`PAT. NO. 8,962,685
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`Here, Petitioner properly named as real parties in interest three interrelated
`
`affiliate entities and two individuals who control those entities. The three entities
`
`named in the petition are: (1) the Petitioner, Harvest Trading Group, Inc.; (2)
`
`ProMera Health, LLC; and (3) HTG Ventures, LLC. (Paper 1, at 2-3). The two
`
`individuals are John T. Lewis, Jr. and James P. Lewis. Id. at 3. As shown by the
`
`management and ownership structure of the entities, these five parties are heavily
`
`related:
`
`0 Petitioner, a corporation, has three officers who are James Lewis
`
`(President), John Lewis (Treasurer), and Kensinger (Secretary). (Ex.
`
`2004, p. 1). These same three individuals also own Petitioner. (EX.
`
`2002, ‘H 30, 42 ; Ex. 2003, ‘]I‘][ 30, 42; Ex. 2001, ‘j[ 7).
`
`0 HTG Ventures, a limited liability company, has three members who
`
`coincide with the officers and owners of Petitioner: John Lewis, James
`
`Lewis, and Kensinger. (EX. 2002, ‘H 3; EX. 2003, ‘I[ 3; Ex. 2001, ‘H 8).
`
`The managers of HTG Ventures are also the same three individuals.
`
`(Ex. 2005, at 2; Ex. 2001, ‘J1 8).
`
`0 ProMera, a limited liability company, has three members, which
`
`include HTG Ventures and the Patent Owner (Vireo). (Ex. 2005, at 2;
`
`Ex. 2001,
`
`‘ll 6). ProMera’s managers were previously John Lewis,
`
`9
`
`
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`IPR20l6-00947
`
`PAT. NO. 8,962,685
`
`Kensinger, and Mark Faulkner (a co—inventor of the ‘685 Patent). (Ex.
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`2006, p. 1; Ex. 2001, ‘ll 6). Faulkner has since resigned as a manager
`
`following the termination of the business relationship between, Owner,
`
`Petitioner, and ProMera. (Ex. 2001, ‘H 6).
`
`Inexplicably, Petitioner failed to name another party—Kensinger——who has
`
`the ability to control these proceedings “that might reasonably be expected between
`
`two formal parties”——i. e. John Lewis (or James Lewis) and Petitioner (or HTG
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`Ventures). Galderma, Paper 14, at *7. Kensinger has important relationships with
`
`all of the named real parties in interest. In particular, Kensinger is on equal footing
`
`with the two individuals named in the petition; he has the ability as an officer,
`
`manager, or owner to control all three entities named in the petition; and other
`
`evidence establishes that he actually exercises this control. Thus, based on logic and
`
`specific factors enumerated by the Board, Kensinger is a real party in interest.
`
`As a matter of logic, Petitioner presumably named both John Lewis and James
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`Lewis as real parties in interest in the Petition due to their ability to control the
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`proceeding. As Kensinger shares equal management and ownership statuses,
`
`Kensinger presumptively has
`
`the same ability to control
`
`this proceeding.
`
`Specifically, like James Lewis and John Lewis, Kensinger is an officer and owner
`
`of Petitioner, and he is a member and manager of HTG Ventures. And like John
`
`10
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`
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`IPR2016—00947
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`PAT. NO. 8,962,685
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`Lewis, Kensinger is also a manager of ProMera. Kensinger is therefore a coequal of
`
`real parties in interest John Lewis and James Lewis, and with that power, he “can
`
`influence [the] [P]etitioner’s actions .
`
`.
`
`. to the [same] degree.” Amazon. com, Paper
`
`18, at *4.
`
`The factors enumerated by the Board confirm this conclusion. First,
`
`Kensinger has “a financially controlling interest” in Petitioner, Zoll, Paper 13, at *9,
`
`because he is one of three owners of Petitioner, (Ex. 2002, ‘M 30, 42; Ex. 2003, ‘H
`
`30, 42; Ex. 2001, ‘j[ 7). Second, in addition to his ownership interest, Kensinger has
`
`a relationship with Petitioner based on his status as an officer. (Ex. 2004, p. 1). And
`
`third, the nature of Petitioner and HTG Ventures suggests that Kensinger is able to
`
`control this proceeding. See Zoll, Paper 13, at *9 (listing “the nature of the entity
`
`filing the petition” as a relevant consideration). Petitioner is a closely held
`
`corporation comprised of Kensinger and two named real parties in interest, and HTG
`
`Ventures is a limited liability company owned and managed by the same named
`
`parties and Kensinger. Based on this substantial evidence, it is clear that Kensinger
`
`“possesse[s] effective control over [the Petitioner]’s conduct.” Galderma, Paper 14,
`
`at *7. Indeed, Petitioner and its owners (John Lewis, James Lewis, and Kensinger)
`
`caused HTG Ventures to manage ProMera according to their wishes. (Ex. 2001, ‘H
`
`7).
`
`ll
`
`
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`IPR20l6-00947
`
`PAT. NO. 8,962,685
`
`Moreover, Kensinger’s ability to control
`
`the proceedings is not
`
`just
`
`“theoretical,” it is “practical.” Galderma, Paper 14, at *7. As Faulkner explains in
`
`his declaration, Kensinger is actively involved in the management of ProMera, and
`
`he has “co—equal[]” power to control the operations of that entity. (Ex. 2001, ‘ll 11).
`
`Indeed, “Kensinger is a manager of ProMera and has a controlling role as one of
`
`ProMera’s two managers.” Id. Moreover, “Kensinger control[s] and direct[s] various
`
`aspects of ProMera’s operations and litigation strategy,” which included overseeing
`
`“ProMera’s position as Vireo’s licensee on intellectual property issues.” Id. ‘J1 12.
`
`Thus, not only does Kensinger theoretically possess the ability to control this
`
`proceeding, he has “effective control over a party’s conduct” such that he is properly
`
`considered a real party in interest. Galderma, Paper 14, at *7.
`
`The Board should deny this Petition because Petitioner failed to name a real
`
`party in interest. Denial is appropriate because any amendment to the petition would
`
`be futile as time—barred. See Amazon. com, Paper 18, at *6—7 (explaining that
`
`amendment would be futile where petition would fall outside “the one—year period
`
`specified by 35 USC. § 315(b)”).
`
`Finally, even if the Board is not convinced, the evidence at a minimum
`
`“reasonably brings into question the accuracy of [the] [P]etitioner’s identification of
`
`the real parties-in-interest.” Galderma, Paper 14, at *6—7. To the extent that the
`
`12
`
`
`
`IPR20l6-00947
`
`PAT. NO. 8,962,685
`
`Board allows Petitioner the opportunity to present additional evidence and argument
`
`related to the real parties in interest, Patent Owner requests the opportunity to seek
`
`additional discovery limited to this issue. As the parties have already exchanged
`
`discovery that is probative of this topic in the related litigation identified by both
`
`parties, Patent Owner expects that the burden of such additional discovery will be
`
`negligible provided that the parties can reach an agreement about the use of that
`
`discovery that complies with the relevant protective orders. Patent Owner expects
`
`that such additional discovery would conclusively establish that Petitioner failed to
`
`satisfy its burden of naming all real parties in interest in its petition, 35 U.S.C. §
`
`3 l2(a)(2).
`
`V.
`
`THE BOARD SHOULD EXERCISE ITS DISCRETION AND
`REJECT PETITIONER’S RELIANCE ON ALMADA AND ZHANG
`AS BEING PREVIOUSLY CONSIDERED.
`
`Under 35 U.S.C. § 325(d), the Board has discretion to reject an IPR petition
`
`where “the same or substantially the same prior art or arguments previously were
`
`presented to the Office.” Id. Under the facts and circumstances here, the Board
`
`should exercise its discretion to deny the portions of the Petition relying on Almada
`
`and Zhang under § 325 (d) because both references have been essentially considered
`
`13
`
`
`
`IPR20l6—00947
`
`PAT. NO. 8,962,685
`
`by an examiner in original prosecution of this patent, and by the Board in a prior IPR
`
`petition concerning the ‘450 Patent.
`
`Almada and Zhang were submitted in an IDS in original prosecution of
`
`application No. 13/740,909, (Ex. 2008, at p. 81), which issued as the ‘685 Patent.
`
`The examiner reviewed the references and allowed the ‘685 Patent claims over
`
`Almada and Zhang. The references appear on the face of the ‘685 Patent as being
`
`reviewed. Petitioner raises no new information here to question the original
`
`examiner’s judgment. For this reason alone, the Board should exercise its discretion
`
`to deny the Petition.
`
`Additionally, Almada and Zhang were previously raised in an IPR petition
`
`concerning the ‘450 Patent. The ‘685 Patent claims are closely related to the ‘450
`
`Patent as shown below by the representative claims:
`
`‘450 Patent
`1. A supplement comprising:
`
`‘685 Patent
`1. A formula comprising:
`
`creatine HCl, wherein the creatine creatine HCl in an amount of about 500
`
`HCl possesses a solubility of at least mg to about 2000 mg, wherein the
`
`600 mg/ml in water at 25° C after a creatine HCl
`
`exhibits
`
`an
`
`aqueous
`
`time period of about 1.5 hours.
`
`solubility that is at least about 15 time
`
`greater than that of creatine monohydrate.
`
`14. A supplement comprising:
`
`8. A formula comprising:
`
`14
`
`
`
`IPR20l6-00947
`
`PAT. NO. 8,962,685
`
`creatine HCl, wherein the creatine a first creatine having a solubility of at
`
`HCl possesses a solubility of at least
`
`least about 150 mg/ml, in water at 25° C
`
`679 mg/ml +/— 18 mg/ml in water at after a time period of about 1.5 hours,
`
`25° C. after a time period of about 1.5 wherein the
`
`first creatine comprises
`
`hours, and wherein the creatine HCl is creatine HCl in an amount of about 500
`
`at least 95% free of contaminants.
`
`mg to about 2000 mg.
`
`19. A supplement comprising:
`
`14. A formula comprising:
`
`creatine HCl, wherein the creatine creatine HCl in an amount of about 500
`
`HCl
`
`is
`
`at
`
`least
`
`95% free
`
`of mg to about 2000 mg, wherein the
`
`contaminants.
`
`creatine HCl is at least about 95% free of
`
`contaminants.
`
`(Ex. 1101; Ex. 1134). In particular, elements such as solubility in excess of
`
`150 mg/ml, temperature and time on the solubility measurement, and the purity of
`
`the claimed creatine HCl are common across both patents.
`
`A different petitioner presented both Almada and Zhang to the USPTO as part
`
`of a combination of Various obviousness challenges to the ‘450 Patent. (IPR20l4-
`
`00451, Paper 2, at 3-5). The Board denied institution on all grounds except with
`
`respect to a combination of Vennerstrom together with Almada and Zhang as to a
`
`single c1aim—Claim 19. (IPR2014—0045 1, Paper 10, at 17). Here, Petitioner is trying
`
`to meet an even higher hurdle: that Almada alone anticipates certain claims of the
`
`15
`
`
`
`IPR20 l 6-00947
`
`PAT. NO. 8,962,685
`
`‘685 Patent, or that Almada and Zhang together——-without Vennerstrom——render all
`
`‘685 Patent claims obvious. The Board had the art and the opportunity to consider
`
`these references against the highly similar ‘450 Patent claims before and declined to
`
`institute a proceeding with respect to these or other presented grounds for all but l
`
`claim.
`
`Accordingly, Patent Owner respectfully submits that
`
`the Board should
`
`exercise its discretion under 35 U.S.C. § 325(d) and conclude that, similar to the
`
`finding of the Examiner in the ‘685 Patent and the prior IPR petition against the ‘450
`
`Patent, as to the claims of the ‘685 Patent, Almada and Zhang do not raise a
`
`reasonable likelihood of invalidity.
`
`VI. THE ‘685 CLAIMS ARE ENTITLED TO A FILING DATE OF AT
`
`LEAST MAY 14, 2004.
`
`The ‘685 Patent was filed on January 14, 20l3, as a continuation of the ‘450
`
`Patent filed on October 21, 2010. The ‘450 is a continuation—in-part (“CIP”) of U.S.
`
`Patent No. 8,026,385 (the “‘385 Patent”) filed on June 3, 2009, which is itself a
`
`continuation of U.S. Patent No. 7,608,641 (the “‘64l Patent” or “Parent
`
`Application”), filed on May 14, 2004. The ‘64l Patent claims priority to U.S.
`
`Provisional Application 60/470,356, filed May 15, 2003. For the reasons set forth
`
`l6
`
`
`
`IPR2016-00947
`
`PAT. NO. 8,962,685
`
`below, the ‘685 Patent is entitled at least to the May 14, 2004 priority date of the
`
`‘64l Patent.
`
`A claim in a later application is entitled to the priority of an earlier application
`
`“if the earlier application shows the subject matter that is claimed in the later
`
`application, with adequate direction as to how to obtain it.” Kennecott Corp. v.
`
`Kyocera Intern, 835 F.2d 1419, 1422 (Fed. Cir. 1987); 35 U.S.C. § 120 (“An
`
`application for patent for an invention disclosed in the manner provided by section
`
`ll2(a) .
`
`.
`
`. in an application previously filed in the United States .
`
`. .shall have the
`
`same effect, as to such invention, as though filed on the date of the prior appl
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