Trials@uspto.gov Paper No. 74
`571.272.7822 Filed: November 28, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA(USA) LTD.,
`SHANDONG LUYE PHARMACEUTICAL CO., LTD., and
`NANJING LUYE PHARMACEUTICAL CO., LTD.,
`Petitioner,
`v.
`ALKERMES PHARMA IRELAND LTD. and
`ALKERMES CONTROLLED THERAPEUTICS, INC.,
`Patent Owner.
`____________________
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`____________
`
`Before LORA M. GREEN, ROBERT A. POLLOCK, and
`JACQUELINE T. HARLOW, Administrative Patent Judge.
`
`GREEN, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`Determining That Claims 1‒13 and 17‒23 Have Not Been Shown to Be
`Unpatentable
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`
`571.272.7822 Filed: November 28, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA(USA) LTD.,
`SHANDONG LUYE PHARMACEUTICAL CO., LTD., and
`NANJING LUYE PHARMACEUTICAL CO., LTD.,
`Petitioner,
`v.
`ALKERMES PHARMA IRELAND LTD. and
`ALKERMES CONTROLLED THERAPEUTICS, INC.,
`Patent Owner.
`____________________
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`____________
`
`Before LORA M. GREEN, ROBERT A. POLLOCK, and
`JACQUELINE T. HARLOW, Administrative Patent Judge.
`
`GREEN, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`Determining That Claims 1‒13 and 17‒23 Have Not Been Shown to Be
`Unpatentable
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`
`INTRODUCTION
`I.
`Luye Pharma Group Ltd., Luye Pharma (USA) Ltd., Shandong Luye
`Pharmaceutical Co., Ltd., and Nanjing Luye Pharmaceutical Co., Ltd.
`(collectively “Petitioner”) filed a Petition requesting an inter partes review
`of claims 1‒13 and 17‒23 of U.S. Patent No. 6,667,061 B2 (Ex. 1001, “the
`’061 patent”). Paper 5 (“Pet.”). Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc. (collectively, “Patent Owner”) filed
`a Preliminary Response to the Petition. Paper 11 (“Prelim. Resp.”). We
`determined that the information presented in the Petition and the Preliminary
`Response demonstrated that there was a reasonable likelihood that Petitioner
`would prevail in challenging claims 1–13 and 17‒23 as unpatentable under
`35 U.S.C. § 103(a). Pursuant to 35 U.S.C. § 314, we instituted trial on
`November 30, 2016, as to those claims of the ’061 patent. Paper 13
`(“Institution Decision” or “Dec. Inst.”).
`Patent Owner filed a Response (Paper 33, “PO Resp.”), to which
`Petitioner filed a Reply (Paper 40). Patent Owner filed Observations on the
`Cross-Examination of Patrick DeLuca (Paper 50), to which Petitioner filed a
`Response (Paper 59). Patent Owner was authorized to file a paper
`identifying what it considered to be new and improper arguments in
`Petitioner’s Reply (Paper 44), to which Petitioner was allowed a response
`(Paper 46). Patent Owner filed a Motion to Exclude (Paper 51), to which
`Petitioner filed an Opposition (Paper 57), and Patent Owner filed a Reply
`(Paper 62). Petitioner also filed a Motion to Exclude (Paper 47), to which
`Patent Owner filed an Opposition (Paper 56), and Petitioner filed a Reply
`(Paper 61). With authorization from the Board, Petitioner filed a second
`Motion to Exclude (Paper 70), to which Patent Owner filed an Opposition
`
`2
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`(Paper 71), and Petitioner filed a Reply (Paper 72). Oral hearing was held
`on August 28, 2017, and a transcript of that hearing has been entered into the
`record. Paper 73 (“Tr.”).
`We have jurisdiction under 35 U.S.C. § 6. Petitioner bears the burden
`of proving unpatentability of the challenged claims, and the burden of
`persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l
`Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner
`must establish facts supporting its challenge by a preponderance of the
`evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`Based on the record before us, we conclude that Petitioner has failed
`to demonstrate by a preponderance of the evidence that claims 1–13 and 17‒
`23 of the ’061 patent are unpatentable. Moreover, we dismiss Patent
`Owner’s Motion to Exclude as improper. We also deny Petitioner’s Motions
`to Exclude in part, and dismiss in part.
`Related Proceedings
`A.
`Petitioner filed a second request for inter partes review seeking
`cancellation of claims 1‒13 and 17‒23 of the ’061 patent on other grounds.
`Pet. 1; Prelim. Resp. 1 n.1. That petition for inter partes review, IPR2016-
`01095, was denied. IPR2016-01095, Paper 13.
`The ’061 Patent
`B.
`The ’061 patent issued on December 23, 2003, with J. Michael
`
`Ramstack, M. Gary I. Riley, Stephen E. Zale, Joyce M. Hotz, and Olufunmi
`L. Johnson as the listed co-inventors. Ex. 1001. According to the ’061
`patent, it is drawn “to injectable suspensions having improved injectability.”
`Id. at 1:13‒14.
`
`3
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`
`
`The ’061 patent discloses:
`Injectable suspensions are heterogeneous systems that
`typically consist of a solid phase dispersed in a liquid phase, the
`liquid phase being aqueous or nonaqueous. To be effective and
`pharmaceutically acceptable, injectable suspensions should
`preferably be: sterile; stable; resuspendable; syringeable;
`injectable; isotonic; and nonirritating. The foregoing
`characteristics result in manufacturing, storage, and usage
`requirements that make injectable suspensions one of the most
`difficult dosage forms to develop.
`Id. at 1:17‒25.
`
`The ’061 patent teaches that viscosity enhancers are added to injection
`vehicles to prevent settling of particles, but notes that viscosity is kept low to
`facilitate mixing and make the suspension easier to inject. Id. at 2:25‒30.
`According to the ’061 patent, it was “unexpectedly discovered that
`injectability is improved, and in vivo injectability failures significantly and
`unexpectedly reduced, by increasing the viscosity of the fluid phase of an
`injectable suspension.” Id. at 4:57‒60. The ’061 patent teaches that “is in
`contrast to conventional teachings that an increase in the viscosity hinders
`injectability and syringeability.” Id. at 4:60‒62. The ’061 patent
`specifically teaches that carboxymethyl cellulose (“CMC”) is a viscosity
`enhancing agent. Id. at 12:14‒20.
`
`The ’061 patent specifically teaches the following injection vehicles:
`Vehicle A: 0.9% saline and 0.1% Tween 20; Vehicle B: 1.5% CMC, 30%
`sorbitol, and 0.2% Tween 20; and Vehicle C: 3% CMC, 0.1% Tween 20,
`and 0.9% saline. Id. at 9:38‒46. According to the ’061 patent, Vehicle A
`had a viscosity of 1.0 cp, Vehicle B had a viscosity of 24 cp, and Vehicle C
`had a viscosity of 56 cp. Id. at 10:Table 4.
`
`4
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`
`Illustrative Claim
`C.
`Petitioner challenges claims 1‒13 and 17‒23 of the ’061 patent.
`Claim 1, the only independent claim of the ’061 patent, is representative:
`1.
`A composition suitable for injection through a needle
`into a host, comprising:
`microparticles comprising a polymeric binder; and
`an injection vehicle, wherein said microparticles are suspended
`in said injection vehicle at a concentration of greater than about
`30 mg/ml to form a suspension, wherein a fluid phase of said
`suspension has a viscosity greater than about 20 cp and less
`than about 600 cp at 20º C., wherein the viscosity of said fluid
`phase of said suspension provides injectability of the
`composition through a needle ranging in diameter from 18–22
`gauge.
`Ex. 1001, 18:6‒17 (emphasis added).
`Instituted Challenges
`D.
`We instituted trial on the following grounds (Pet. 33):
`References
`Basis
`Claims Challenged
`Johnson1 and Kino2
`§ 103
`1‒13, 22, and 23
`Gustafsson,3 Ramstack,4 and
`§ 103
`1‒3, 6‒9, 12, 13, and
`the Handbook5
`17‒23
`
`
`1 Johnson et al., U.S. Patent No. 5,654,010, issued August 5, 1997
`(Ex. 1009) (“Johnson”).
`2 Kino et al., U.S. Patent No. 5,656,299, issued August 12, 1997 (Ex. 1010)
`(“Kino”).
`3 Gustafsson et al., WO 97/14408, published April 24, 1997 (Ex. 1011)
`(“Gustafsson”).
`4 Ramstack et al., WO 95/13799, published May 26, 1995 (Ex. 1005)
`(“Ramstack”).
`5 HANDBOOK OF PHARMACEUTICAL EXCIPIENTS, 78‒81, 135‒138, 294‒298,
`329‒330, 375‒378, 420‒421, 439‒442, 477‒482 (Ainley Wade and Paul J
`
`5
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`
`Petitioner relies on the Declaration of Patrick P. Deluca, Ph.D.
`(Ex. 1002), as well as his Supplemental Declaration (Ex. 1024).
`Patent Owner relies on the Declarations of Cory J. Berkland, Ph.D.,
`(Ex. 2014), Robson F. Storey, Ph.D. (Ex. 2054), and Stevin Gehrke, Ph.D.
`(Ex. 2059).
`
`II. ANALYSIS
`Petitioner bears the burden of proving unpatentability of the
`challenged claims, and that burden of persuasion never shifts to Patent
`Owner. Dynamic Drinkware, 800 F.3d at 1378. To prevail, Petitioner must
`establish the facts supporting its challenge by a preponderance of the
`evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). Below, we explain why
`Petitioner has failed to meet its burden with respect to the challenged claims.
`Claim Construction
`A.
`In an inter partes review, claim terms in an unexpired patent are
`interpreted according to their broadest reasonable construction in light of the
`specification of the patent in which they appear. See 37 C.F.R. § 42.100(b);
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–45 (2016)
`(upholding the use of the broadest reasonable interpretation standard).
`Under that standard, we presume that a claim term carries its “ordinary and
`customary meaning,” which “is the meaning that the term would have to a
`person of ordinary skill in the art in question” at the time of the invention.
`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). See also
`Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1062 (Fed. Cir. 2016) (“Under
`a broadest reasonable interpretation, words of the claim must be given their
`
`
`Weller, ed., Am. Pharm. Ass’n & Pharm. Press 2nd ed. 1994) (Ex. 1008)
`(“the Handbook”).
`
`6
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`plain meaning, unless such meaning is inconsistent with the specification
`and prosecution history.”). Any special definition for a claim term must be
`set forth in the specification with reasonable clarity, deliberateness, and
`precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`In the Institution Decision, we determined that none of the terms in
`the challenged claims require express construction at that time. Dec. Inst. 6
`(citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed.
`Cir. 1999) (noting that only claim terms which are in controversy need to be
`construed, and then only to the extent necessary to resolve the controversy));
`see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868
`F.3d 1013, 1017 (Fed. Cir. 2017). Petitioner offers explicit constructions of
`several claim terms (Pet. 19‒22), as did Patent Owner in its Preliminary
`Response (Prelim. Resp. 9‒12). In its full Response, Patent Owner states
`that there is no need to expressly construe any of the claim terms. PO Resp.
`13‒14. On the present record, we agree with Patent Owner and determine
`that none of the claim terms require explicit construction for purposes of this
`Decision.
`
`B. Level of Ordinary Skill in the Art
`Petitioner contends that at the time of invention, the ordinary artisan
`would have had “at least a bachelor’s degree and/or a number of years of
`industry training or experience in one or more the following fields:
`pharmaceutical formulation, chemistry, pharmaceutical science, polymer
`chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics,
`and/or pharmacology.” Pet. 19 (citing Ex. 1002 ¶¶ 8‒13).
`Patent Owner responds that the ordinary artisan “would have a
`bachelor’s degree in one of the following fields: pharmaceutical formulation,
`
`7
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`chemistry, polymer science, or a related field, and one or two years of
`industry training or experience in those field(s).” PO Resp. 8 (citing Ex.
`2014 ¶ 21; Ex. 2054 ¶ 27).
`
`We conclude that, for practical purposes, there is little difference
`between Petitioner’s and Patent Owner’s definitions of the ordinary artisan.
`Thus, our analysis would be the same under either Petitioner’s or Patent
`Owner’s definition. In addition, the level of ordinary skill in the art in this
`case is reflected by the prior art of record. See Okajima v. Bourdeau,
`261 F.3d 1350, 1355 (Fed. Cir. 2001).
`C. Obviousness over Johnson and Kino
`Petitioner contends that claims 1‒13, 22, and 23 are rendered obvious
`by the combination of Johnson and Kino. Pet. 23‒38. Petitioner presents a
`claim chart demonstrating where the limitations of the challenged claims
`may be found in the relied upon references. Id. at 32‒38. Patent Owner
`disagrees with Petitioner’s contentions, asserting that the Petition fails to
`demonstrate the obviousness of the challenged claims by a preponderance of
`the evidence. PO Resp. 14‒34.
`i.
`Overview of the Prior Art Relied Upon
`
`
`
`We find the following as to the teachings of the relevant prior art.
`a.
`Overview of Johnson (Ex. 1009)
`Johnson “relates to a composition, and methods of forming and using
`said composition, for the sustained release of biologically active, stabilized
`human growth hormone (hGH).” Ex. 1009, 1:42‒45. The method of
`forming the composition includes the steps of “dissolving a biocompatible
`polymer in a polymer solvent to form a polymer solution, dispersing
`particles of biologically active, stabilized hGH in the polymer solution, and
`
`8
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`then solidifying the polymer to form a polymeric matrix containing a
`dispersion of said hGH particles.” Id. at 1:52‒57.
`
`Example 7 of Johnson evaluated “the pharmacokinetic profiles of
`different hGH sustained release formulations as compared to more
`traditional methods of administering hGH.” Id. at 12:19‒24. Monkeys were
`administered a dose of 160 mg of hGH sustained release microspheres in
`1.2 ml of injection vehicle using a 20 gauge needle. Id. at 12:37‒42.
`Johnson teaches that the “injection vehicle was an aqueous vehicle
`containing 3% w/v Carboxymethyl Cellulose (sodium salt), 1% v/v Tween
`20 (Polysorbate 20) and 0.9% sodium chloride.” Id. at 12:42‒45.
`Overview of Kino (Ex. 1010)
`b.
`
`Kino teaches:
`With the aim of improvement in compliance at the time
`of maintenance therapy with hydrophobic antipsychotic drugs,
`the present inventors have conducted intensive studies on the
`development of a sustained release pharmaceutical preparation
`in which a drug itself is used as an active ingredient without
`modification. As the result, it was found that a drug can be
`released at an almost constant rate extending over 1 week or
`more by including a hydrophobic antipsychotic drug in the form
`of microcrystals having an average particle size of 10 µm or
`less, desirably 5 µm or less, into a base comprising a
`biodegradable high molecular weight polymer having in vivo
`histocompatibility to make a sustained release microsphere
`preparation and administrating it by subcutaneous or
`intramuscular injection.
`Ex. 1010, 1:66‒2:12.
`
`Kino teaches that the microspheres may be made into a sustained
`release injection by preparing an aqueous suspension along with a dispersing
`agent, such as polysorbate 80 or CMC, a preservative, and an isotonic agent,
`such as sodium chloride or sorbitol. Id. at 4:38‒44. Kino teaches also that
`
`9
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`when used as a suspension for injection, the particle size of the
`microparticles “may be a range which can satisfy their dispersibility and
`needle-passing property, for example, in the range of from about 0.5 to about
`400 µm, more preferably from about 0.5 to about 200 µm, most preferably
`from about 15 to 50 µm as an average particle size.” Id. at 4:32‒37.
`ii.
`Analysis
`A claim is unpatentable under 35 U.S.C. § 103(a) if “the differences
`between the subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations, including: (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art;
`(3) the level of skill in the art; and (4) objective evidence of nonobviousness,
`i.e., secondary considerations. Id. (citing Graham v. John Deere Co.,
`383 U.S. 1, 17–18 (1966)).
`
`In addition, the Court of Appeals for the Federal Circuit has
`acknowledged that “inherency may supply a missing limitation in an
`obviousness analysis.” PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d
`1186, 1194‒95 (Fed. Cir. 2014). The Federal Circuit has cautioned,
`however, that the use of inherency in an obviousness analysis must be
`carefully circumscribed. Id. at 1195. “To establish inherency, the extrinsic
`evidence ‘must make clear that the missing descriptive matter is necessarily
`present in the thing described in the reference.’” In re Robertson, 169 F.3d
`743, 745 (Fed. Cir. 1999) (quoting Continental Can Co. v. Monsanto Co.,
`
`10
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`948 F.2d 1264, 1268 (Fed. Cir. 1991)). Inherency “may not be established
`by probabilities or possibilities. The mere fact that a certain thing may result
`from a given set of circumstances is not sufficient.” In re Oelrich, 666 F.2d
`578, 581 (CCPA 1981). For example, where the practice of a prior art
`example sometimes, but not always, yields the claimed product, anticipation
`is not established. Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043, 1047–48
`(Fed. Cir. 1995).
`Petitioner relies on Johnson for teaching “microspheres suspended in
`an aqueous injection vehicle.” Pet. 24 (citing Ex. 1009, 10:64‒66; Ex. 1002
`¶¶ 54, 59). Petitioner contends that “Johnson teaches a solution of 3% w/v
`carboxymethyl cellulose (low viscosity), polysorbate 20, and sodium
`chloride used as the injection vehicle; the same components as used in
`Vehicle C of the ’061 Patent.” Id. (citing Ex. 1009, 12:39‒42; Ex. 1002
`¶¶ 55, 59). Petitioner asserts further that Johnson teaches that a
`concentration of microparticles of 133 mg/ml, which, Petitioner argues, is
`greater than the concentration of a minimum of 30 mg/ml required by the
`challenged claims. Id. at 24‒25 (citing Ex. 1009, 12:39‒42; Ex. 1002 ¶¶ 54,
`59). In addition, Petitioner notes that the “formulation is suitable for
`injection into a patient via a 20 gauge needle, which is within the claimed
`range of 18–22 gauge.” Id. at 25 (citing Ex. 1009, 12:39-42; Ex. 1002 ¶¶ 54,
`59).
`Petitioner acknowledges that “Johnson is silent as to the viscosity of
`
`the . . . formulation.” Id. Petitioner contends, however, that the ordinary
`artisan would understand that CMC is a viscosity enhancing agent, and that
`it “would be considered the viscosity-controlling component of an injection
`vehicle.” Id. (citing Ex. 1008, 78; Ex. 1002 ¶ 61).
`
`11
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`Petitioner notes further that during prosecution, the applicants relied
`
`on the Declaration of Dr. Mark A. Tracy (Ex. 1018), in which Dr. Tracy
`“offered the conclusion that Kino taught a viscosity less than 7 cp based
`solely on the amount of CMC present in the Kino examples.” Pet. 25. Thus,
`Petitioner asserts, the ordinary artisan “would appreciate that the injection
`vehicle disclosed in Johnson would have substantially the same viscosity of
`the preferred embodiment of the ’061 Patent and as a result fall within the
`scope of claim 1.” Id. (citing Ex. 1002 ¶¶ 60, 61).
`According to Petitioner:
`Based on the Patent Owner’s admission during prosecution of
`the ‘061 Patent, the Tracy Declaration, and what would be
`known to [the ordinary artisan], [the ordinary artisan] would
`reasonably expect the injection vehicle of Johnson — having
`3% CMC — to have a viscosity greater than 27cp at 20°C and
`certainly within the claimed range of 20-600cp at 20°C.
`Johnson therefore teaches every limitation of claims 1-3. (Ex.
`1002 ¶ 60, 61).
`Id. at 25‒26; see also id. at 33 (claim chart) (citing Ex. 1002 ¶¶ 27, 54, 59,
`61).
`
`Petitioner is, therefore, relying on the doctrine of inherency in
`contending that the injection vehicle of Johnson inherently has the viscosity
`required by the challenged claims. See Tr. 116 (Petitioner’s counsel noting
`that they are relying inherency to meet the viscosity limitation); see also PO
`
`
`6 Petitioner also argued during the oral hearing that it would have been
`obvious to one of ordinary skill in the art to optimize viscosity. Tr. 16‒17.
`Petitioner pointed to pages 7‒9 of its Petition to support that assertion.
`Tr. 23. Those pages, however, as noted during the argument (Tr. 23‒24),
`were in the Background section of the Petition discussing improving
`injectability, and did not explain how the combination of Johnson and Kino
`rendered the claimed viscosity obvious.
`
`12
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`Resp. 2 (“Petitioners argue that the injection vehicle formulations disclosed
`in the primary references of both grounds, Johnson and Gustafsson, would
`inherently have viscosities between 20 cp and 600 cp at 20ºC as claimed in
`the ’061 patent.”).
`
`Patent Owner responds that Petitioner has not met the high burden of
`establishing inherency, and, in particular, has “failed to establish that the
`type or grade of CMC used in the Johnson or Gustafsson vehicles would
`necessarily have achieved the claims viscosity.” PO Resp. 2; id. at 14
`(“Johnson does not expressly or inherently meet the viscosity limitations of
`the claims.”).
`
`Patent Owner argues that, as acknowledged by both the Petition (Pet.
`25) and the Decision on Institution (Dec. Inst. 9‒10), Johnson does not
`specify the viscosity of its injection vehicle. PO Resp. 16. Moreover, Patent
`Owner asserts, Johnson “provides insufficient information to ascertain the
`viscosity of its injection vehicle or to conclude that it is necessarily the same
`as that of a preferred embodiment of the ’061 patent.” Id. (citing Ex. 2014
`¶¶ 81, 87.)
`
`In particular, Patent Owner notes that “Petitioners rely on Johnson’s
`disclosure of an injection vehicle comprised of 3% CMC, 1% polysorbate
`20, and 0.9% sodium chloride.” Id. at 18 (citing Pet. 24). Patent Owner
`states that it “asked Dr. Stevin Gehrke to make the Johnson vehicle using
`commercially available CMCs.” Id. (citing Ex. 2059 ¶¶ 5-12; Ex. 2014
`¶¶ 47-50). According to Patent Owner, “Dr. Gehrke recorded the viscosity
`at 20ºC as 6.03 cp when the vehicle was made with Ashland 7ULC CMC
`and 9.41 cp when the vehicle was made with Ashland 7ELC1 CMC,
`
`13
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`which both fall below the claimed range.” Id. (citing Ex. 2059 ¶¶ 7, 12; Ex.
`2014 ¶¶ 47-50).
`
`Patent Owner asserts that Petitioner did not offer any testing data of
`its own, but rather, asserts based on the Tracy Declaration that CMC is the
`viscosity controlling component, and, thus, the ordinary artisan could predict
`the viscosity based only on the amount of CMC in the formulation. Id. at
`18‒19 (citing Pet. 25; Ex. 2016, 252:18‒253:7; Ex. 2014 ¶¶ 76‒86).
`
`Patent Owner argues further that Petitioner has not demonstrated that
`“Johnson disclosed a specific type and grade of CMC that would necessarily
`cause the viscosity of its vehicle to fall within the claimed range at 20ºC,” or
`that “all available grades and types of CMC would necessarily cause
`Johnson’s vehicle to fall within the claimed viscosity range.” PO Resp. 20‒
`21. Patent Owner notes in particular that Johnson does not specify the type
`or grade of CMC that it used. Id. at 21 (citing Ex. 2014 ¶¶ 51‒56; Ex. 2016,
`227:9‒11, 230:14‒231:21). The claimed injection vehicle, Patent Owner
`asserts, requires a particular viscosity, that is, a viscosity greater than about
`20 cp and less than about 600 cp at 20º C. Id. Petitioner has not shown,
`Patent Owner asserts, “that the Johnson vehicle is inevitably such a vehicle.”
`Id. at 22 (citing Ex. 2014 ¶¶ 81, 87).
`
`Patent Owner argues additionally that even if the CMC of Johnson is
`considered to be the viscosity controlling component, the absence of any
`disclosure in Johnson as to the grade and type of CMC used in its injection
`vehicle “makes it impossible to establish that the viscosity is necessarily in
`the claimed range.” Id. (citing Ex. 2014 ¶¶ 51‒61; Ex. 2016, 147:10‒16,
`176:2‒24). There were a wide variety of grades and types of CMC that were
`available at the time of invention, which, Patent Owner argues, “could yield
`
`14
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`a wide-range of possible viscosities for CMC solutions, even at a fixed
`concentration.” Id. (citing Ex. 1008, 79; Ex. 2034, 15; Ex. 2014 ¶¶ 37‒41,
`51‒61; Ex. 2016, 183:1‒6).
`
`According to Patent Owner, Petitioner’s own reference, the
`Handbook, supports that many viscosities are possible, as its states that
`“aqueous 1% w/v solutions [of CMC] with viscosities of 5-4000 mPas (5-
`4000 cP) may be obtained.” PO Resp. 22 (quoting Ex. 1008, 79). Patent
`Owner also cites the 1999 Aqualon brochure (Ex. 2034) as well as Dow
`Chemical (Ex. 2036) as demonstrating that a range of viscosities for
`solutions containing the products are possible. Id. at 23 (citing Ex. 2034, 6,
`15; Ex. 2036; Ex. 2014 ¶¶ 41, 53‒55). In addition, Patent Owner argues, as
`supported by the 1999 Aqualon brochure, if medium or high grade CMC
`were used in the injection vehicle of Johnson, viscosities higher than those
`claimed could result. Id. at 23‒24 (citing Ex. 1008, 79, Table 1; Ex. 2014
`¶¶ 60‒61; Ex. 2034, 15; Ex. 2014 ¶¶ 60‒61; Ex. 2016, 230:14‒231:21).
`
`As to the Tracy Declaration, Patent Owner notes that it was originally
`submitted with Application No. 09/577,875 (“the ’875 Application”), “Dr.
`Tracy explained that ‘CMC is the viscosity-controlling component of the
`injection vehicle of Test Example 2’” of Kino, as it used a 0.5% CMC
`solution isotonized with mannitol. PO Resp. 11 (citing Ex. 1018 ¶ 5). Table
`1 of the Tracy Declaration, which Patent Owner states “summarizes the
`information Dr. Tracy relied upon in reaching his conclusions regarding
`Kino test Example 2,” is reproduced below:
`
`15
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`
`
`
`Id. at 11‒12.
`
`According to Patent Owner, “[b]ecause Kino did not disclose the
`viscosity of its Test Example 2, in order to make a comparison between
`Kino Test Example 2 and the ’875 application, Dr. Tracy had to assume that
`the Kino CMC was the same as that used in the ’875 application.” Id. at 12
`(citing Ex. 2014 ¶¶ 83-85; Ex. 2016, 176:2-24). Patent Owner asserts “[t]hat
`assumption and conclusion were also consistent with Kino’s use of
`physiological saline alone in three of the four exemplified vehicles, all of
`which had a viscosity of 1 cp—far below the claimed viscosity range.” Id.
`at 12‒13 (citing Ex. 1010, 6:19, 6:43‒44, 7:8‒9; Ex. 2014 ¶¶ 78‒85).
`
`Patent Owner contends that the Tracy Declaration does not support
`that CMC is the viscosity controlling components of Johnson’s injection
`vehicle, as the declaration does not relate to Johnson. Id. at 20 (citing Ex.
`2014 ¶¶ 77‒81). Patent argues further that “the grade and type of CMC in
`Johnson’s vehicle and how the vehicle is prepared are . . . highly relevant to
`the viscosity of the injection vehicle.” Id. That is, Patent Owner argues,
`although “the grade and type of CMC and preparation of the vehicles may be
`the same in Johnson as in the ’875 application, Johnson provides no such
`
`16
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`information and Petitioners do not and cannot establish that this is
`necessarily the case.” Id.
`Challenged independent claim 1 requires that the “fluid phase of said
`suspension has a viscosity greater than about 20 cp and less than about 600
`cp at 20º C.” As noted in the Decision on Institution and discussed above,
`Johnson does not specifically teach that viscosity limitation. Dec. Inst. 10.
`Petitioner relies on Johnson’s teaching an injection vehicle comprising 3%
`w/v CMC, 1 % polysorbate 20, and 0.9% sodium chloride. Pet. 24. As we
`noted further in the Decision on Institution, the ’061 patent teaches Vehicle
`C, which comprises 3% CMC, 0.1% Tween 20 (i.e., polysorbate 20), and
`0.9% saline, and has a viscosity of 56 cp. Dec. Inst. 11 (citing Ex. 1001,
`9:45; 10:Table 4). In the Decision on Institution, we determined that the
`evidence of record at that time sufficiently established a reasonable
`likelihood that as the injection vehicle of Johnson and Vehicle C are
`substantially the same, except for the concentration of polysorbate 20, the
`injection vehicles would be expected to have similar, if not the same
`viscosities, especially as the ’061 patent teaches that CMC is a viscosity
`enhancing agent. Id. Based on the argument and evidence developed during
`trial, however, we determine that Petitioner has not demonstrated by a
`preponderance of the evidence that the Johnson vehicle inherently has the
`viscosity required by the challenged claims.
`
`In that regard, we note that Petitioner must “meet a high standard in
`order to rely on inherency to establish the existence of a claim limitation in
`the prior art in an obviousness analysis—the limitation at issue necessarily
`must be present, or the natural result of the combination of elements
`
`17
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`explicitly disclosed by the prior art.” PAR Pharm., Inc., 773 F.3d at 1195‒
`96.
`As noted by Dr. Berkland, Dr. Gehrke7 made the vehicle of Johnson
`
`using “two different types of low viscosity CMC: 7ULC and 7ELCI from
`Ashland.” Ex. 2014 ¶ 48; Ex. 2059 ¶¶ 6‒7. According to Dr. Berkland:
`each of these Ashland CMCs yielded a Johnson vehicle with a
`viscosity below 20 cp when measured at 20ºC and thus fall
`outside the range claimed in the ’061 patent. ([Ex. 2059] ¶ 12.)
`
`
`
`Ex. 2014 ¶ 50.
`
`The testing performed by Dr. Gehrke is the only data provided during
`the proceeding of testing of the vehicle of Johnson, and demonstrates that
`viscosities lower than those required by the claim were obtained. The data
`provided by Dr. Gehrke, therefore, is evidence that the injection vehicle of
`Johnson would not necessarily have the viscosity required by the challenged
`claims.
`
`Moreover, the Handbook (Ex. 1008), supports the finding that a
`solution having the same percentage of CMC may not necessarily all have
`the same viscosity. Specifically, the Handbook teaches:
`Viscosity: various grades of carboxymethylcellulose sodium are
`commercially available which have differing aqueous
`
`7 We note that Petitioner elected not to take the deposition of Dr. Gehrke.
`Tr. 63.
`
`18
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`
`viscosities; aqueous 1% w/v solutions with viscosities of 5-
`4000 mPa s (5-4000 cP) may be obtained. An increase in
`concentration results in an increase in aqueous solution
`viscosity. Viscosities of various grades of
`carboxymethylcellulose sodium are shown in Table I. . . .
`
`
`Ex. 1008, 79 (footnote omitted). Thus, the Handbook is further evidence
`that the percentage of CMC used is not determinative of the viscosity of the
`solution, but that a solution with various viscosities may be obtained.
`Petitioner has not presented any evidence demonstrating that even if these
`difference in viscosities were taken into account, the solution of Johnson
`would necessarily have the viscosity required by the challenged claims. See
`Tr. 14 (Petitioner’s counsel acknowledging that it has not performed any
`testing).
`
`That finding is also supported by the testimony of Petitioner’s expert,
`Dr. DeLuca. Dr. DeLuca testifies:
`Q. Okay. Is it because the CMC that comes from two different
`suppliers can have different characteristics?
`A. They could, yes.
`Q. They could have different viscosity ranges?
`A. They could vary in viscosity range, yeah.
`Q. So it was important to you to consider different suppliers of
`CMC in coming up with your opinion today because the
`characteristics of the CMC can vary from supplier to supplier,
`right?
`A. Yes.
`
`
`
`19
`
`
`
`IPR2016-01096
`Patent 6,667,061 B2
`
`Ex. 2081, 102:22‒103:13; see also Paper 50, 5 (pointing out Dr. DeLuca’s
`testimony in this regard). Again, as the viscosity can change depending not
`just on its grade, but also on the supplier, the preponderance of the evidence
`does not support Petiti
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
