IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`HARVEST TRADING GROUP, INC.
`
`Petitioner
`
`v.
`
`VIREO SYSTEMS, INC. AND
`
`UNEMED CORPORATION
`
`Patent Owner
`
`U.S. PATENT NO. 8,962,685
`
`
`
`Case IPR: Unassigned
`
`
`
`
`
`
`
`
`
`
`
`

`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`INTRODUCTION .......................................................................................... 1
`
`II. GROUNDS FOR STANDING ....................................................................... 1
`
`III. MANDATORY NOTICES (37 C.F.R. § 42.8) .............................................. 2
`A.
`Real Party in Interest (§ 42.8(b)(1)) ..................................................... 2
`B.
`Related Matters (§ 42.8(b)(2)) ............................................................. 3
`C.
`Lead and Backup Counsel (§ 42.8(b)(3)) ............................................. 3
`D.
`Service Information (§ 42.8(b)(4)) ....................................................... 3
`
`IV. PAYMENT OF FEES (37 C.F.R. §§ 42.15(a) and 42.103) ........................... 3
`
`V. U.S. PATENT NO. 8,962,685 ........................................................................ 4
`A. Overview .............................................................................................. 4
`B.
`Prosecution History .............................................................................. 4
`C.
`Priority .................................................................................................. 6
`
`VI. CLAIM CONSTRUCTION ........................................................................... 8
`
`VII.
`
`IDENTIFICATION OF CHALLENGED CLAIMS .................................... 13
`A.
`35 U.S.C. §102(b)/103(a) ................................................................... 13
`B.
`35 U.S.C. §103(a) ............................................................................... 14
`
`VIII. DETAILED EXPLANATION OF CHALLENGE ...................................... 14
`A. Overview ............................................................................................ 14
`B. Grounds for Invalidity ........................................................................ 22
`
`IX. CONCLUSION ............................................................................................. 60
`
`
`-i-
`
`

`
`
`
`Exhibit
`1101
`1102
`1103
`1104
`
`1105
`
`1106
`
`1107
`1108
`
`1109
`
`1110
`
`1111
`
`1112
`
`1113
`
`1114
`1115
`
`1116
`1117
`1118
`
`1119
`
`TABLE OF EXHIBITS
`
`Description
`
`U.S. Patent No. 8,962,685
`U.S. Publication No. 2004/0242691
`U.S. Provisional No. 60/470,356
`Docket Sheet: ProMera Health, LLC v. Vireo Sys., Inc., et al., 1:15-cv-
`10595-NMG, D. Mass.
`Second Amended Complaint: ProMera Health, LLC v. Vireo Sys., Inc.,
`et al., 1:15-cv-10595-NMG, D. Mass.
`Zumdahl, Steven S., Chemistry, Third Ed., Heath and Company:
`Lexington MA, 1993. Section 15.6
`Declaration of Richard van Breemen
`Hilal SH et al, Quantitative Treatments of Solute/Solvent
`Interactions: Theoretical and Computational Chemistry Vol. 1,
`Elsevier, pp. 291-353 (1994).
`Gufford et al., Physiochemical Characterization of Creatine N-
`Methylguanidinium Salts, Journal of Dietary Supplements, 7(3); 240-
`252 (2010).
`Abdon et al., On the appearance of phosphocreatine in blood at
`uraemia, Acta Medica Scandinavica, 95(S90); 444-454 (1938).
`Practising Law Institute, Faber on Mechanics of Patent Claim Drafting,
`7th Ed., Chapter 6: Composition of Matter Claims-Chemical Cases.
`Needham et al., Solubiltiy of Amino Acids in Pure Solvent Systems. J.
`Pharm. Sci., 60(4); 565-567 (1971)
`Cannan et al., CXV. The Creatine-Creatinine Equilibrium. The
`Apparent Dissociation Constants of Creatine and Creatinine. Bioch.
`59: 920-929 (1928).
`CN101407478
`How CON-CRET™ Works Website 2004 available at:
`https://web.archive.org/web/20041206041250/http://concret.com/howit
`works.html.
`U.S. Pat. No. 5,627,172
`MSDS CON-CRET™ Rev. Date: August 18, 2004.
`Bastin et al., Salt Selection and Optimisation Procedures for
`Pharmaceutical New Chemical Entities, Org. Process Res. Dev., 4,
`427-435 (2000).
`Heymsfield, et al., Assessing Skeletal Muscle Mass: Historical
`Overview and State of the Art, 5: 9-18 (2014).
`
`-ii-
`
`

`
`
`
`Exhibit
`1120
`
`1121
`
`1122
`
`1123
`
`1124
`
`1125
`1126
`1127
`1128
`
`1129
`1130
`
`1131
`1132
`1133
`1134
`
`Description
`Folin and Denis, Protein Metabolism from the Standpoint of Blood
`and Tissue Analysis: Third Paper. Further Absorption
`Experiments with Especial Reference to the Behavior of Creatine
`and Creatinine and to the Formation of Urea, Journal of Biological
`Chemistry (1912); 12: 141-162.
`Benedict and Osterberg, Studies in Creatine and Creatinine
`Metabolism V. The Metabolism of Creatine, Journal of Biological
`Chemistry (1923); 56: 229-252.
`Chanutin, The Fate of Creatine when Administered to Man, Journal
`of Biological Chemistry (1926); 67: 29-41.
`Pick, Hollinck and Zacharellis, Uber Hemmungs and Potenzierungs-
`Phanomene am quergestreiften Muskel, Arch. exper. Patn u.
`Phamakol, 220: 83-99 (1953).
`Buford, et al., International Society of Sports Nutrition position
`stand: creatine supplementation and exercise, Journal of
`International Society of Sports Nutrition, 4: 6 (2007).
`U.S. Patent No. 3,933,797
`Creatinine HCl Data Sheet- Sigma Aldrich
`Declaration of Brad Curran
`Hunter, A., Creatine and Creatine, Monographs on Biochemistry,
`Vol. 8, Longmans, Green and Co, Ltd., p. 36 (1928)
`Richard van Breemen CV
`Jager et al, Analysis of the efficacy, safety, and regulatory status of
`novel forms of creatine, Amino Acids 40:1369-1383 (2011)
`Response filed January 18, 2011 in U.S. App. No. 12/4,77,413
`CON-CRET® Label Proof Copyright 2008
`File Wrapper ‘685 Patent
`U.S. Patent No. 8,354,450
`
`-iii-
`
`

`
`
`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342 (Fed. Cir. 1999) ............................. 20
`
`Augustine Med., Inc. v. Gaymar Indus., Inc., 181 F.3d 1291 (Fed. Cir.
`1999) ..................................................................................................................... 7
`
`In re Best, 562 F.2d 1252 (CCPA 1977) ............................................................ 20, 23
`
`Bristol-Myers Squibb v. Ben Venue Labs, 246 F.3d 1368 (Fed. Cir.
`2001) ................................................................................................................... 49
`
`In re Chu, 66 F.3d 292 (Fed. Cir. 1995) .................................................................... 7
`
`Clio USA, Inc. v. The Procter and Gamble Co., IPR2013-00438 (Jan.
`9, 2014, Paper 9 at 7) ............................................................................................ 1
`
`In re Cuozzo Speed Techs., LLC, 778 F. 3d. 1271 (Fed. Cir. 2015),
`cert. granted, 136 S. Ct. 890 (January 15, 2016) .................................................. 8
`
`In re Donohue, 766 F.2d 531 (Fed. Cir. 1985) ........................................................ 20
`
`Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955 (Fed.Cir.2001) ............... 23, 49, 52
`
`Florida Dep’t of State v. Treasure Salvors, Inc., 458 U.S. 670 (1982) ..................... 2
`
`Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992) .......................... 20
`
`In re Huston, 308 F.3d 1267 (Fed. Cir. 2002) ........................................................... 7
`
`Jet, Inc. v. Sewage Aeration Sys., 223 F.3d 1360 (Fed. Cir. 2000) ........................... 2
`
`In re Kratz, 592 F.2d 1169 (CCPA 1979) .................................................... 23, 49, 52
`
`Kropa v. Robie, 187 F.2d 150 (CCPA 1951) ............................................................. 9
`
`Lockwood v. Am. Airlines, Inc., 107 F.3d 1565 (Fed. Cir. 1997) .............................. 7
`
`Phillips v. AWH Corp., 415 F. 3d 1303 (Fed. Cir. 2005) .................................. 48, 52
`
`Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298 (Fed. Cir.
`1999) ..................................................................................................................... 9
`
`-vi-
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`

`
`Page
`
`PowerOasis, Inc. v. T-MOBILE USA, Inc., 522 F. 3d 1299 (Fed. Cir.
`2008) ..................................................................................................................... 7
`
`Promera Health, LLC. v. Vireo Sys., Inc. et al., 1:15-cv-10595 (D.
`Mass.) .................................................................................................................... 3
`
`Promera Health, LLC. v. Vireo Sys., Inc. et al., 8:16-cv-00008 (D.
`Neb.) ...................................................................................................................... 3
`
`ProMera Health, LLC v. Vireo Sys., Inc., et al., 1:15-cv-10595-NMG .................... 1
`
`Rowe v. Dror, 112 F.3d 473 (Fed. Cir. 1997) ............................................................ 9
`
`In re Spada, 911 F.2d 705 (Fed. Cir. 1990) ........................................... 20, 24, 49, 52
`
`STX LLC. v. Brine, 211 F.3d 588 (Fed. Cir. 2000) .................................................... 9
`
`In re Translogic Tech., Inc., 504 F.3d 1249 (Fed. Cir. 2007) ................................... 8
`
`UNeMed Corp. et al. v. Promera Health, LLC et al., 8:15-cv-00135
`(D. Neb.) ............................................................................................................... 3
`
`Vadas v. US, 527 F.3d 16 (2d Cir. 2007) ................................................................... 2
`
`VasCath Inc. v. Mahurkar, 935 F.2d 1555 (Fed.Cir.1991) ....................................... 7
`
`STATUTES
`35 U.S.C. § 102(b) ...........................................................................13, 23, 34, 40, 48
`
`35 U.S.C. §102(b)/103(a) ......................................................................................... 13
`
`35 U.S.C. §103(a) ............................................................................13, 14, 23, 34, 40
`
`35 U.S.C. § 112, first paragraph ............................................................................... 7
`
`35 U.S.C. §§311-319 .................................................................................................. 1
`
`35 U.S.C. §315(a)(1) .............................................................................................. 1, 2
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.8 ......................................................................................................... 2
`
`37 C.F.R. §§ 42.15(a) ................................................................................................. 4
`
`-v-
`
`

`
`Page
`
`37 C.F.R. § 42.100 ..................................................................................................... 1
`
`37 C.F.R. § 42.100(b) ................................................................................................ 8
`
`37 C.F.R. §§ 42.103(a) ............................................................................................... 4
`
`37 C.F.R. §42.104(a) .................................................................................................. 1
`
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 2
`
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 3
`
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 3
`
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 3
`
`Federal Rule of Civil Procedure 15(a) ................................................................... 1, 2
`
`Federal Rule of Civil Procedure 41(a) ................................................................... 1, 2
`
`MPEP 716.02(b) ....................................................................................................... 20
`
`MPEP 2112 .............................................................................................................. 20
`
`MPEP 2112.II ........................................................................................................... 23
`
`MPEP 2112.V .......................................................................................................... 20
`
`MPEP 2112.01 ............................................................................................. 24, 49, 52
`
`MPEP 2141.02 ........................................................................................................... 8
`
`MPEP 2144.04.VII ................................................................................................... 28
`
`
`
`-vi-
`
`

`
`Case No.: Not yet assigned
`Patent 8,962,685
`
`I.
`
`INTRODUCTION
`
`Petitioner Harvest Trading Group, Inc. (“Petitioner”), requests Inter Partes
`
`Review (“IPR”) of claims 1-20 of U.S. Patent No. 8,962,685 (the “‘685 Patent,”
`
`Ex. 1101) in accordance with 35 U.S.C. §§311-319 and 37 C.F.R. § 42.100 et seq.
`
`II. GROUNDS FOR STANDING
`
`Pursuant 37 C.F.R. §42.104(a), Petitioner certifies that the ‘685 Patent is
`
`available for IPR, and Petitioner is not barred or estopped from requesting IPR
`
`challenging the claims of the ‘685 Patent on the grounds identified in this petition.
`
`Real party-in-interest, ProMera Health, LLC, (“ProMera”), filed a
`
`declaratory judgment action against Vireo Sys., Inc., The Board of Regents of the
`
`University of Nebraska, and UNeMed Corporation on February 27, 2015, alleging
`
`non-infringement and invalidity of the ‘685 Patent. ProMera Health, LLC v. Vireo
`
`Sys., Inc., et al., 1:15-cv-10595-NMG, D. Mass. The docket sheet from this case is
`
`attached as Ex. 1104. On January 6, 2016, ProMera filed a second amended
`
`complaint pursuant to Federal Rule of Civil Procedure 15(a) that dropped all of the
`
`non-infringement and invalidity counts directed to the ‘685 Patent. Ex. 1105.
`
`ProMera’s declaratory judgment action does not bar institution of IPR of the
`
`‘685 Patent. An IPR is not barred under 35 U.S.C. §315(a)(1) where a declaratory
`
`judgment action has been voluntarily dismissed without prejudice pursuant to
`
`Federal Rule of Civil Procedure 41(a). Clio USA, Inc. v. The Procter and Gamble
`
`
`
`

`
`Case No.: Not yet assigned
`Patent 8,962,685
`Co., IPR2013-00438 (Jan. 9, 2014, Paper 9 at 7) (“when an action is dismissed
`
`without prejudice, the parties are free to litigate the matter in a subsequent action,
`
`as though the dismissed action had never existed”).
`
`Voluntary dismissals without prejudice under Rule 41(a) are functionally
`
`equivalent to amendments to pleadings that drop claims pursuant to Rule 15(a).
`
`Jet, Inc. v. Sewage Aeration Sys., 223 F.3d 1360, 1364 (Fed. Cir. 2000).
`
`Amending a complaint to drop previously asserted claims renders the previously
`
`asserted claims null, just like a voluntary dismissal without prejudice. Florida
`
`Dep’t of State v. Treasure Salvors, Inc., 458 U.S. 670, 702 (1982) and Vadas v.
`
`US, 527 F.3d 16, 22 n. 4 (2d Cir. 2007). Accordingly, ProMera’s second amended
`
`complaint that dropped all counts directed to the ‘685 Patent pursuant to Rule 15(a)
`
`should be considered equivalent to a voluntary dismissal without prejudice under
`
`Rule 41a. Consistent with several PTAB decisions, ProMera’s declaratory
`
`judgment action should not bar institution of IPR under 35 U.S.C. §315(a)(1). See
`
`e.g,. Clio USA, IPR2013-00438.
`
`III. MANDATORY NOTICES (37 C.F.R. § 42.8)
`
`A.
`
` Real Party in Interest (§ 42.8(b)(1))
`
`The real parties-in-interest (“RPI”) of this petition are Harvest Trading
`
`Group, Inc. located at 61 Accord Park Drive, Norwell, Massachusetts 02061;
`
`ProMera Health, LLC, located at 61 Accord Park Drive, Norwell, Massachusetts
`
`-2-
`
`

`
`Case No.: Not yet assigned
`Patent 8,962,685
`02061; and HTG Ventures, LLC, located at 61 Accord Park Drive, Norwell,
`
`Massachusetts 02061; John T. Lewis, Jr. residing at 390 Hatherly Road, Scituate,
`
`Massachusetts 02066; and James P. Lewis residing at 119 Mann Hill Road
`
`Extension, Scituate, Massachusetts 02066.
`
`B.
`
` Related Matters (§ 42.8(b)(2))
`
`The ‘685 Patent was the subject of: Promera Health, LLC. v. Vireo Sys.,
`
`Inc. et al., 1:15-cv-10595 (D. Mass.); and is the subject of UNeMed Corp. et al. v.
`
`Promera Health, LLC et al., 8:15-cv-00135 (D. Neb.); and Promera Health, LLC.
`
`v. Vireo Sys., Inc. et al., 8:16-cv-00008 (D. Neb.). Vireo Sys, Inc. and RPI are also
`
`involved in litigation in Tennessee State Court and the Middle District of
`
`Tennessee relating to Vireo’s ownership interest in Promera Health, LLC.
`
`C.
`
` Lead and Backup Counsel (§ 42.8(b)(3))
`
`Lead Counsel
`Raymond A. Miller, Reg. 42,891
`500 Grant St., Suite 5000
`Pittsburgh, PA 15212
`412-454-5813
`millerra@pepperlaw.com
`
`
`D.
`
`Backup Counsel
`Curtis Wadsworth, J.D., Ph.D., Reg. 57, 475
`500 Grant St., Suite 5000
`Pittsburgh, PA 15212
`412-454-5832
`wadsworthc@pepperlaw.com
`
`Service Information (§ 42.8(b)(4))
`
`Please send correspondence to lead counsel at the address above.
`
`IV. PAYMENT OF FEES (37 C.F.R. §§ 42.15(a) and 42.103)
`
`The required fees are submitted herewith in accordance with 37 C.F.R. §§
`
`42.103(a) and 42.15(a). If any additional fees are due during this proceeding, the
`
`-3-
`
`

`
`Case No.: Not yet assigned
`Patent 8,962,685
`Office is authorized to charge such fees to Deposit Account No. 50-0436. Any
`
`overpayment or refund of fees may also be deposited in this Deposit Account.
`
`V. U.S. PATENT NO. 8,962,685
`
`A.
`
` Overview
`
`The claims of the ‘685 Patent are directed to formulae containing Crt-HCl
`
`that exhibit solubilities of “at least about 15 times greater than creatine
`
`monohydrate [“CM”]” or “at least about 150 mg/mL” and/or are “at least 95
`
`percent free of contaminants.”
`
`B.
`
`
`
`Prosecution History
`
`The ‘685 Patent was filed in the U.S. on January 14, 2013 as U.S.
`
`Application No. 13/740,909 and issued on February 24, 2015. The ‘685 Patent
`
`claims priority from U.S. Pat. No. 8,354,450 (the “‘450 Patent”), which was filed
`
`on October 21, 2010 as U.S. App. No. 12/909,377, and issued on January 15, 2013.
`
`The ‘450 Patent is a continuation-in-part (“CIP”) of U.S. Pat. No. 8,026,385, (the
`
`“‘385 Patent”), which was filed on June 3, 2009 as U.S. App. No. 10/846,782 and
`
`issued on September 27, 2011. The ‘385 Patent is a continuation of U.S. Pat. No.
`
`7,608,641 (the “‘641 Patent”), which was filed on May 14, 2004 as U.S. App. No.
`
`12/477,413, issued on October 27, 2009, and claims priority from U.S. Pro. No.
`
`60/470,356 (the “‘356 Provisional”), filed on May 15, 2003. The ‘685 Patent
`
`includes 20 total claims, of which claims 1, 8, and 14 are independent claims. A
`
`-4-
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`

`
`Case No.: Not yet assigned
`Patent 8,962,685
`Non-Final Office Action was mailed on February 20, 2014 in which claims 1-16
`
`were rejected on obviousness-type double patenting grounds over claims 1-7 of the
`
`‘385 Patent. A Response and Amendment was filed on June 20, 2014, in which
`
`independent claims 1, 8 and 14 were amended, to recite that the creatine HCl in the
`
`formula is “in an amount of about 500 mg to about 2000 mg” “to clarify,” and a
`
`terminal disclaimer was filed against the ‘385 Patent. A Final Office Action was
`
`mailed on August 14, 2014, in which the terminal disclaimer filed with the June
`
`20, 2014 Response was rejected for identifying a party who is not the Applicant.
`
`Claims 1-7 and 17 were deemed allowable and claims 8-16 and 18-20 were
`
`rejected on the grounds of obviousness-type double patenting. A response to this
`
`Final Office Action was filed on October 14, 2014, in which a revised Terminal
`
`Disclaimer was filed. A Notice of Allowance was issued on October 24, 2014.
`
`The ‘685 Patent issued on February 4, 2015. A request for certificate of correction
`
`was filed on February 8, 2016, in which Applicant requested that the dependency
`
`of claim 16 be changed from claim “14” to claim “15.”1 The Office approved this
`
`request on March 31, 2016.
`
`
`1 This correction appears to correct the lack of antecedent basis for the term
`
`“the dietary supplement” in claim 16, which depends from claim 14.
`
`-5-
`
`

`
`Case No.: Not yet assigned
`Patent 8,962,685
`
`C.
`
`
`
`Priority
`
`The ‘685 Patent issued from a CIP application. Priority for CIP applications
`
`is determined on a claim-by-claim basis. Augustine Med., Inc. v. Gaymar Indus.,
`
`Inc., 181 F.3d 1291, 1302-03 (Fed. Cir. 1999). A claim that contains new matter
`
`will not be entitled to a priority date earlier than the CIP application’s filing date.
`
`In re Chu, 66 F.3d 292, 297 (Fed. Cir. 1995). All of the claims of the ‘685 Patent
`
`contain new matter, and therefore are not entitled to the priority of the grandparent
`
`applications, but rather a priority date of October 21, 2010.
`
`To satisfy the written description requirement, the specification of the prior
`
`application must “convey with reasonable clarity to those skilled in the art that, as
`
`of the filing date sought, [the Applicant] was in possession of the invention.”
`
`VasCath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed.Cir.1991) (emphasis
`
`original). “Entitlement to a filing date does not extend to subject matter which is
`
`not disclosed, but would be obvious over what is expressly disclosed.” In re
`
`Huston, 308 F.3d 1267, 1277 (Fed. Cir. 2002) (quoting Lockwood v. Am. Airlines,
`
`Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997)).
`
`Claims 1-20 of the ‘685 Patent should be entitled to a priority date no earlier
`
`than the filing date of its parent application, U.S. App. No. 12/909,377 (now U.S.
`
`Pat. No. 8,354,450). Where the Office has not addressed the priority of CIP
`
`claims, the patent owner has the burden of proving that the claims at issue in the
`
`-6-
`
`

`
`Case No.: Not yet assigned
`Patent 8,962,685
`CIP are entitled to the filing date of the parent application. PowerOasis, Inc. v. T-
`
`MOBILE USA, Inc., 522 F. 3d 1299, 1303-05 (Fed. Cir. 2008). Neither the
`
`Examiner nor the PTAB has expressly determined the priority for each of the
`
`claims of the ‘685 Patent, and Patent Owner has made no effort to establish a
`
`priority date for the claims of the ‘685 Patent earlier than October 21, 2010.
`
`The grandparent application (U.S. App. No. 12/477,413) and great-
`
`grandparent application (U.S. App. No. 10/846,782) share a common specification
`
`(see U.S. Pub. No. 2004/0242691, the “2004 Publication,” Ex. 1102), and depend
`
`from U.S. Provisional App. No. 60/470,356 (Ex. 1103) (collectively, the
`
`“Grandparent Applications”). The Grandparent Applications do not provide
`
`written description support under 35 U.S.C. § 112, first paragraph for at least the
`
`following terms: (1) the claimed amount of 500 mg to 2000 mg (claims 1-20); (2)
`
`the recited temperature and time parameters: “at 25° C after a time period of about
`
`1.5 hours” (claims 8-13 and 20); and (3) the numerical limitation relating to
`
`contaminants: “at least 95% free of contaminants” (claims 14-20). All of the
`
`claims contain one or more of these undisclosed elements, and these elements are
`
`incorporated into all of the dependent claims. For example, the Grandparent
`
`Applications are entirely silent regarding the amount of Crt-HCl that is to be
`
`administered or the dosage. All of claims 1-20 include this “amount” limitation.
`
`Therefore, the ‘685 Patent should not be entitled to claim priority to the
`
`-7-
`
`

`
`Case No.: Not yet assigned
`Patent 8,962,685
`Grandparent Applications. Claims 1-20 of the ‘685 Patent should be afforded a
`
`priority date no earlier than October 21, 2010.
`
`VI. CLAIM CONSTRUCTION
`
`In an inter partes review, “[a] claim in an unexpired patent shall be given its
`
`broadest reasonable construction in light of the specification of the patent in which
`
`it appears.” 37 C.F.R. § 42.100(b). See In re Cuozzo Speed Techs., LLC, 778 F. 3d.
`
`1271, 1281 (Fed. Cir. 2015), cert. granted, 136 S. Ct. 890 (January 15, 2016) see
`
`also In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Unless
`
`otherwise noted below, Petitioner accepts, for purposes of this IPR only, that the
`
`claim terms of the ’685 Patent are presumed to take on the ordinary and customary
`
`meaning that they would have to one of ordinary skill in the art.
`
`1.
`
`Level of Skill in the Art
`
`Considering the relevant factors for determining the appropriate level of skill
`
`in the art (i.e., (A) “type of problems encountered in the art;” (B) “prior art
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`solutions to those problems;” (C) “rapidity with which innovations are made;” (D)
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`“sophistication of the technology; and” (E) “educational level of active workers in
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`the field.), see MPEP 2141.02, a person of ordinary skill in the art (“POSITA”) to
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`which the ‘685 Patent is directed would have at least a master’s degree or the
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`equivalent thereof in biological sciences or chemistry with several years of
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`experience performing chemical synthesis and analysis. Ex. 1107, 10.
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`2.
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`“A formula”
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`The term “formula” is used in the preamble and recites the purpose or
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`intended use of the invention. Thus, this term does not limit the claim. See Pitney
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`Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, (Fed. Cir. 1999) and
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`Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997) (statements of a purpose or
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`intended use for the invention in the preamble are not limiting); see also, Kropa v.
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`Robie, 187 F.2d 150, 152 (CCPA 1951) and STX LLC. v. Brine, 211 F.3d 588, 591
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`(Fed. Cir. 2000). To the extent the term “formula” is considered a limitation, this
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`term should be construed as “a list of the ingredients used for making something.”
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`3.
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`“creatine HCl”
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`The term “creatine HCl” should be construed as “a substance that includes
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`as a major component creatine having a hydrochloride counterion.” Ex. 1101,
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`9:56-65, claim 14 and Ex. 1107, 12.
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`4.
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`“possessing a solubility”
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`In the chemical arts, “solubility” means “the maximum amount of a
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`substance that can be dissolved in a solvent at equilibrium.” Ex. 1105, Ex. 1107,
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`19. As discussed below, the maximum amount of creatine that can be dissolved in
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`water is higher at high and low pH because creatine is a zwitterion. In water, the
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`hydrochloride (HCl) counterion of creatine HCl (“Crt-HCl”) dissociates from the
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`creatine and ionizes, releasing H+ ions and decreasing the pH of the water. The
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`decrease in pH makes creatine more soluble, increasing the amount of creatine that
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`can be dissolved in the water. Thus, rather than being a fixed number, the
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`solubility of Crt-HCl changes depending on the pH of the solution. Crt-HCl
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`therefore possesses a variable solubility that depends on the aqueous environment
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`and
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`the amount of Crt-HCl (or other HCl containing by-products or
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`“contaminants”) dissolved in the solution. As such, the term “possessing a
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`solubility” in the claims of the ‘685 Patent must reflect the variability in solubility
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`and unrecited pH and should be construed as “capable of possessing the recited
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`solubility level.”
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`Measuring solubility requires the solution to be at equilibrium. Ex. 1106 at
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`pg. 549. Each creatine molecule can exist in one of three ionic forms when
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`dissolved in water:
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`
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`The concentration of these ionic forms depends on the pH of the solution.
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`At low pH, more H+ ions are available to satisfy the negative charge on the
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`carboxylic acid this causes the equilibrium concentration of creatine ions to shift to
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`the left in the above equation. Creatine is in its least soluble, fully charged,
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`zwitterion form at neutral pH (above middle). Ex. 1107, 24. The pKa, acid
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`dissociation constant, represents the pH at which the highly soluble, protonated
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`acid form or creatine (left) is at equilibrium with its conjugated base (zwitterion
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`creatine, middle). Id. At low pH, the equilibrium concentration of fully protonated
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`creatine and zwitterion creatine shifts to the left, meaning that more creatine is in
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`the high solubility form increasing the overall solubility of the creatine added to
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`the solution. Ex. 1107, 23-29.
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`The HCl of Crt-HCl ionizes after dissociating from the creatine molecule
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`introducing H+ ions into the solution. Ex. 1107, 21. This lowers the pH of the
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`solution, shifting the equilibrium concentration of less soluble zwitterion creatine
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`towards more soluble fully protonated creatine. Id., 23-29. The addition of
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`“contaminants” having HCl counterions such as creatinine HCl and creatine ethyl
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`ester HCl, which are described as the “main impurities” of Crt-HCl preparations in
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`the ‘450 Patent, see Ex. 1101, 9:56-65, also contribute HCl to the solution, causing
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`a reduction in its pH and increasing the concentration of high solubility, fully
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`protonated creatine. Ex. 1107, 33-34. Therefore, the solubility of Crt-HCl is
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`largely independent of purity.
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`At the time of the invention, the POSITA would have been aware of these
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`principles and would have understood that the solubility of Crt-HCl increases as
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`Crt-HCl is added to the water. Ex. 1107, 40 see also Ex. 1109 at 247, 250. The
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`claims of the ‘685 Patent should be construed as encompassing any pH. Because
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`the maximum amount of creatine that can be dissolved in water depends on the pH,
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`the claims of the ‘685 Patent encompass any Crt-HCl “capable of possessing the
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`recited solubility level” at any pH.
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`5.
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`“15 times greater than creatine monohydrate”
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`The ‘685 Patent teaches that creatine monohydrate (“CM”) has an aqueous
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`solubility of “about 10 to about 16 mg/mL,” Ex. 1101, 4:13-15, and provides
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`measured aqueous solubility for CM of 15 mg/mL, Id., 11:11-19, and 17.9 ± 0.5
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`mg/mL, Id. 11:40-45. Because the lowest solubility for CM provided in the ‘685
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`Patent is 10 mg/mL, the term “15 times greater than [CM]” should be construed as
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`“150 mg/mL (10 mg/mL x 15).” Ex. 1107, 41.
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`6.
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`“at 25°C after a time period of 1.5 hours”
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`The claimed time and temperature at which solubility is measured, “at 25°C
`
`after a time period of 1.5 hours” should not be given patentable weight. Where a
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`reference is silent as to temperature, the POSITA would understand the experiment
`
`to have been carried out under standard laboratory conditions, 25°C, or at room
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`temperature, 23°C. Ex. 1107, 42. Solubility measurements taken at room
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`temperature (i.e., 23°C) will not be statistically different from solubility
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`measurements taken at 25°C. Id. The recited time period, “1.5 hours,” merely
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`provides a time point for measurement. The ‘685 Patent states that Crt-HCl
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`achieves a solubility of 888 mg/ml after two minutes at room temperature (i.e.,
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`25°C) suggesting that equilibrium is reached after two minutes. Ex. 1101, 11:10-
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`25. The ‘685 Patent further describes the “shelf-life” of Crt-HCl as being 45 days
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`or greater in aqueous solution, suggesting that Crt-HCl is stable in an aqueous
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`solution at 2 minutes and remains at equilibrium for 45 days or more. Ex. 1101,
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`6:1-12 and Ex. 1107, 43-44. The solubility of a solution taken at any time point
`
`within this time frame will be effectively the same. Id. As such, the terms, “at
`
`25°C after a time period of 1.5 hours” should not be given patentable weight.
`
`7.
`
` “contaminants”
`
`The term “contaminants” is not defined in the specification. The term
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`“contaminate” is a verb, meaning “1. To make impure or unclean by contact or
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`mixture.” The American Heritage Dictionary of the English Language, 406 (3d ed.
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`1992). Based on the ordinary meanings, the broadest reasonable interpretation of
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`“contaminants” in the context of Crt-HCl supplements is “a material or substance
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`that makes Crt-HCl unclean or impure.”
`
`VII. IDENTIFICATION OF CHALLENGED CLAIMS
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`A.
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`
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`35 U.S.C. §102(b)/103(a)
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`Claims 1-20 of the ‘685 Patent are challenged by this petition as being
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`anticipated under pre-AIA 35 U.S.C. § 102(b) or alternatively under pre-AIA 35
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`U.S.C. §103(a) on the following grounds:
`
`Ground Claims
`1
`1-20
`2
`1, 2, 6, 8,
`
`Exhibit Nos.
`Prior Art
`Ex. 1116
`U.S. Pat. No. 5,627,172 (“Almada”)
`How CON-CRET™ Works Website 2004 Ex. 1115
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`11, 14-20
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`(“CON-CRET™ Website”)
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`B.
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`
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`35 U.S.C. §103(a)
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`Claims 1-20 of the ‘685 Patent are challeng