Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
`
`
` Paper No. 13
`
` Entered: November 30, 2016
`
`
`
`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 IPR2016-01095
`Patent 6,667,061 B2
`____________
`
`
`Before LORA M. GREEN, ROBERT A. POLLOCK, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`

`

`IPR2016-01095
`Patent 6,667,061 B2
`
`
`
`INTRODUCTION
`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.”).
`Institution of an inter partes review is authorized by statute when “the
`information presented in the petition . . . and any response . . . shows that
`there is a reasonable likelihood that the petitioner would prevail with respect
`to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314; see
`37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the
`Preliminary Response, we determine that Petitioner has not demonstrated a
`reasonable likelihood that it would prevail in showing the unpatentability of
`claims 1‒13 and 17‒23. Accordingly, we decline to institute an inter partes
`review of those claims.
`
`Related Proceedings
`A.
`Petitioner states that it has 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, IPR2016-01096, is being decided concurrently with the instant
`proceeding.
`
`The ’061 Patent (Ex. 1001)
`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
`
`2
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`

`IPR2016-01095
`Patent 6,667,061 B2
`
`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 1:12‒14.
`
`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 “microparticles” and
`“microspheres” refer to “particles that contain an active agent or other
`substance dispersed or dissolved within a polymer that serves as a matrix or
`binder of the particle,” wherein the “polymer is preferably biodegradable
`and biocompatible.” Id. at 5:14‒19.
`
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`IPR2016-01095
`Patent 6,667,061 B2
`
`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. The ’061 patent specifically
`teaches that CMC is a viscosity enhancing agent. Id. at 12:14‒20.
`C.
`Challenged Claims
`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, 18:6‒16 (emphasis added).
`D. The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1‒13 and 17‒23 of the
`’061 patent on the following grounds (Pet. 4):
`
`
`
`4
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`

`IPR2016-01095
`Patent 6,667,061 B2
`
`
`References
`Goldenheim1
`
`Basis
`§ 102
`
`§ 103
`
`§ 103
`
`Claims Challenged
`1‒3, 6‒9, 12, 13,
`17‒19, 22, and 23
`1‒3, 6‒9, 12, 13, and
`17‒23
`
`1‒13 and 17‒23
`
`Goldenheim, Ramstack,2
`U.S. Pharmacopeia,3 and the
`European Pharmacopoeia4
`Goldenheim, Kino, 5
`U.S. Pharmacopeia, and the
`European Pharmacopoeia
`
`Petitioner relies also on the Declaration of Patrick P. Deluca, Ph.D.
`(Ex. 1002).
`
`
`
`ANALYSIS
`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).
`
`
`1 Goldenheim et al., WO 99/01114, published January 14, 1999 (Ex. 1004)
`(“Goldenheim”).
`2 Ramstack et al., WO 95/13799, published May 26, 1995 (Ex. 1005)
`(“Ramstack”).
`3 THE UNITED STATES PHARMACOPEIA;USP 23, NF 18, 274‒275, 1840, 2333,
`2390 (U.S. Pharmacopeial Convention, Inc. 1994) (Ex. 1006)
`(“the U.S. Pharmacopeia”).
`4 EUROPEAN PHARMACOPOEIA, 547‒548, 1780 (Council of Europe 3rd ed.
`1996) (Ex. 1007) (“the European Pharmacopoeia”).
`5 Kino et al., U.S. Patent No. 5,656,299, issued August 12, 1997 (Ex. 1010)
`(“Kino”).
`
`5
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`IPR2016-01095
`Patent 6,667,061 B2
`
`Under that standard, we presume that a claim term carries its “ordinary and
`customary meaning,” which “is the meaning the that 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
`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).
`Petitioner offers explicit constructions of several claim terms (Pet. 18‒
`21), as does Patent Owner (Prelim. Resp. 10‒12). On the present record, we
`determine that none of the claim terms require explicit construction for
`purposes of this Decision. See, e.g., Wellman, Inc. v. Eastman Chem. Co.,
`642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be
`construed ‘to the extent necessary to resolve the controversy.’”) (quoting
`Vivid Techs, Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
`1999)).
`
`Anticipation by Goldenheim
`B.
`Petitioner asserts that claims 1‒3, 6‒9, 12, 13, 17‒19, 22, and 23 are
`anticipated by Goldenheim. Pet. 21‒33. Petitioner presents a claim chart
`demonstrating where the limitations of the challenged claims may be found
`in Goldenheim. Id. at 28‒33. Patent Owner contends that Petitioner has not
`established a reasonable likelihood that claims 1‒3, 6‒9, 12, 13, 17‒19, 22,
`and 23 are anticipated by Goldenheim. Prelim. Resp. 15‒24.
`
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`IPR2016-01095
`Patent 6,667,061 B2
`
`
`Overview of Goldenheim (Ex. 1004)
`i.
`Goldenheim relates to “sustained release formulations for the
`administration of locally active agents and/or diagnostic agents in sustained
`release form intra articularly or in other body spaces.” Ex. 1004, 1:6‒8.
`Goldenheim teaches administration of a formulation of a biocompatible
`sustained release material into an articular joint, wherein the active agent
`“can include one or more enzymes, anti-infectives, antibodies, and the like,
`diagnostic agents, as well as local anesthetics, local anesthesia augmenting
`agents and combinations thereof.” Id. at 5:30‒6:3. Goldenheim notes that
`the formulation is suitable also for “administration in all body
`spaces/cavities.” Id. at 10:1‒3. According to Goldenheim, “the formulation
`is in a form suitable for suspension in isotonic saline, physiological buffer or
`other solution acceptable for injection into a patient.” Id. at 8:16‒17.
`
`Specifically, Goldenheim teaches:
`As used herein, the term “microparticles” includes
`microspheres and microcapsules in a size range suitable for
`injection into a desired site of administration by injection,
`infiltration, infusion and the like. For administration by injection
`and/or infiltration or infusion, the formulations according to the
`invention may be suspended (e.g., for microparticles), or
`dissolved (e.g., for immediate release forms), in any art known
`vehicle suitable for injection and/or infiltration or infusion. Such
`vehicles include, simply by way of example, isotonic saline,
`buffered or unbuffered and the like and may optionally include
`any other art known ingredients or agents, e.g., colorants,
`preservatives, antibiotics, epinephrine and other art known
`ingredients.
`Id. at 16:19‒27.
`
`Goldenheim teaches further:
`Microspheres and other injectable substrates described
`herein may be incorporating an effective amount of the same into
`
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`IPR2016-01095
`Patent 6,667,061 B2
`
`
`(e.g., water) or
`a pharmaceutically acceptable solution
`suspension for injection. The final reconstituted product
`viscosity may be in a range suitable for the route of
`administration. In certain instances, the final reconstituted
`product viscosity may be, e.g., about 35 cps. Administration may
`be via the subcutaneous or intramuscular route. However,
`alternative routes are also contemplated, and the formulations
`may be applied to the localized site in any manner known to those
`skilled in the art, such that a localized effect is obtained.
`Id. at 35:8‒16 (emphasis added).
`
`As to administration, Goldenheim teaches:
`A suspension of microspheres prepared in a form suitable
`for intra articular injection can be injected into a joint using
`methods well known to the art. For most body spaces, the use of
`a needle or “skinny needle” is acceptable. The chosen needle is
`one that is small in bore (large) gauge as possible, and as long as
`necessary. Commonly, for a joint, epidural, intraperitoneal,
`intrapleural or bursae, 22-28 gauge, 1-2 inch is used. For the
`microparticles used in the present invention, one should allow for
`increased bore size (e.g., to 18 gauge). This also allows for the
`puncturing needle to be removable, being encased in a plastic
`infusion catheter. For a few procedures, “skinny needles” are
`used. Such needles have the same bores but are longer, and
`hence look “skinny”. For locations such as intrapericardial, the
`gauges for the skinny needle are the same, but the needles can be
`up to 3 -4 inches long. For epidural, and other locations, there is
`a metal puncturing needle of the same gauges and up to 3 inches
`long, often encased in a plastic catheter, through which another
`catheter, from[ ] 22-28 gauge, and up to 6-12 inches long, can be
`inserted into the space.
`Id. at 41:13‒26.
`
`Example 16 of Goldenheim is drawn to in vivo injection of
`microspheres containing a local anesthetic into elderly male baboons. Id. at
`51:21‒52:4; 53:1‒4. As shown in Table 4, the microspheres were
`
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`IPR2016-01095
`Patent 6,667,061 B2
`
`administered at a concentration of 70 mg in 1 ml of vehicle. Id. at 54. The
`vehicle used was 0.5% CMC and 0.1% Tween 80 in water. Id. at 52:27‒28.
`ii.
`Analysis
`Petitioner relies on Goldenheim for teaching “a formulation that
`
`includes microparticles suitable for injection,” wherein “the active agents are
`included in or encapsulated by a polymeric binder.” Pet. 23 (citing Ex.
`1004, Abstract, 26:23‒31; Ex. 1002 ¶¶ 54, 58). Petitioner notes that
`Goldenheim teaches that the formulation may be used with any active agent.
`Id. (citing Ex. 1004, 13:22‒27; Ex. 1002 ¶ 54). Petitioner relies also on
`Goldenheim for its teaching a microparticle concentration of 70 mg/ml, and
`that such compositions may be administered using a 18 gauge needle. Id. at
`24 (citing Ex. 1004, 54:Table 4, 41:17‒19; Ex. 1002 ¶¶ 54, 60).
`
`In particular, Petitioner contends that “Goldenheim teaches that such
`final reconstituted product has a viscosity of 35cp.” Id. at 23 (citing Ex.
`1004, 35:8‒12; Ex. 1002 ¶¶ 54, 59). Petitioner asserts:
`As explained by Dr. DeLuca, [an ordinary artisan] would
`understand that viscosity is typically measured at 20 or 25°C.
`(Ex.1002 ¶¶ 56, 59.) If Goldenheim’s reported viscosity was
`taken at 20°C, then its viscosity is 35cp. If Goldenheim’s
`reported viscosity was taken at 25°C, then the viscosity would
`only be higher at 20°C given the inverse relationship between
`viscosity and temperature. (Ex.1002 ¶ 59.) In either event,
`Goldenheim’s viscosity falls within the claimed range of “greater
`than about 20 cp and less than about 600 cp at 20°C.”
`Id. at 23.
`
`Thus, Petitioner concludes, Goldenheim teaches all of the limitations
`of independent claim 1. Id. at 24.
`
`Patent Owner responds the portion of Goldenheim relied upon by
`Petitioner to meet the viscosity limitation of challenged claim 1 “includes
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`IPR2016-01095
`Patent 6,667,061 B2
`
`only the general statement that ‘[i]n certain instances, the final reconstituted
`product viscosity may be, e.g., about 35 cp.’” Prelim. Resp. 20 (quoting Ex.
`1004, 35:11). Patent Owner contends that “Goldenheim offers no
`information on what those ‘certain instances’ might be.” Id. Patent Owner
`asserts, therefore, that Petitioner has “failed to offer any evidence that such
`“certain instances” are ones that meet all the other claim limitations of the
`’061 patent.” Id.
`
`Patent Owner contends further that Petitioner has improperly picked
`and chosen from unrelated disclosures of Goldenheim to arrive at the subject
`matter of challenged claim 1. Id. at 22. Specifically, according to Patent
`Owner:
`Petitioners combine the concentration of microspheres disclosed
`in Goldenheim’s Example 16 with Goldenheim’s alleged
`viscosity disclosure. However, Petitioners provide no reason [an
`ordinary artisan] would have picked the concentration from
`Example 16, which relates to the injection of “EDLA [Extended
`Duration Local Anesthetic] microparticles into the knee joints of
`adult baboons” (Exh. 1004 at 53:7-8) and combined it with a
`different portion of Goldenheim
`that mentions a final
`reconstituted product viscosity “may be, e.g., about 35 cp” in
`“certain” unidentified
`instances.
` Further, Goldenheim’s
`Example 16 teaches a concentration of 70 mg/ml and there is
`nothing in Goldenheim or the cited art that suggests combining
`such a concentration with a viscosity of 35 cp. Petitioners do not
`provide any reason for such a combination.
`
`Id.
`We agree with Patent Owner that Petitioner has failed to sufficiently
`
`establish a reasonable likelihood that claims 1‒3, 6‒9, 12, 13, 17‒19, 22, and
`23 are anticipated by Goldenheim.
`[U]nless a reference discloses within the four corners of the
`document not only all of the limitations claimed but also all of
`the limitations arranged or combined in the same way as recited
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`
`
`in the claim, it cannot be said to prove prior invention of the thing
`claimed and, thus, cannot anticipate under 35 U.S.C. § 102. . . .
`[I]t is not enough that the prior art reference . . . includes
`multiple, distinct teachings that the artisan might somehow
`combine to achieve the claimed invention.
`Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008)).
`
`Here, as noted by Patent Owner, Petitioner is using disparate
`teachings of the Goldenheim reference to attempt to establish that the claims
`of the challenged patent are anticipated by that reference. The disclosure of
`Goldenheim of a viscosity of 35 cp in certain instances is a single sentence
`from that document, and Goldenheim provides no guidance as to what those
`circumstances may be. Petitioner has not sufficiently established that the
`ordinary artisan would have read that viscosity limitation into the
`formulation used by Example 16, which Petitioner relies upon to meet the
`concentration of microparticles required by challenged claim 1. In that
`regard, we note that Example 16 does not mention viscosity, and specifically
`teaches the use of an injection vehicle of 0.5% CMC and 0.1% Tween 80 in
`water. Ex. 1004, 52:27‒28
`
`Therefore, after considering the Petition and Preliminary Response,
`we determine that Petitioner has failed to sufficiently demonstrate a
`reasonable likelihood that claims 1‒3, 6‒9, 12, 13, 17‒19, 22, and 23 are
`anticipated by Goldenheim.
`C. Obviousness over Goldenheim
`Petitioner asserts that claims 1‒3, 6‒9, 12, 13, and 17‒23 are rendered
`obvious by the combination of Goldenheim, Ramstack, and the two
`Pharmacopoeia (Pet. 33‒43), and that claims 1‒13 and 17‒23 are rendered
`obvious by the combination of Goldenheim, Kino, and the two
`Pharmacopoeia (Pet. 43‒52). Patent Owner responds that Petitioner has
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`IPR2016-01095
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`
`failed to establish that the challenged claims are rendered obvious by the
`cited prior art. Prelim. Resp. 24‒42. As the issues are similar for these two
`challenges, we address them together.
`i.
`Overview of Ramstack (Ex. 1005)
`Ramstack is drawn to the preparation of microparticles that
`encapsulate an active agent. Ex. 1005, 1:14‒17. Ramstack teaches that a
`wide variety of active agents may be encapsulated in the microparticles (id.
`at 30:1‒32:18), including antibodies and enzymes (id. at 32:6‒7), and
`specifically teaches that the active agent may be risperidone (id. at 8:21‒22).
`According to Ramstack the “most preferred polymer for use in the practice
`of this invention is poly(dl-lactide-co-glycolide),” wherein “the molar ratio
`of lactide to glycolide in such a copolymer be in the range of from about
`85:15 to about 50:50.” Id. at 16:28‒31.
`
`Ramstack teaches that the microparticles are stored as a dry material,
`but are suspended in a suitable pharmaceutical liquid vehicle before
`administration, such as a 2.5 wt. % solution of CMC. Id. at 29:27‒31.
`Ramstack provides an example of an aqueous vehicle comprising 0.75%
`CMC, 5% mannitol, and 0.1% Tween 80, wherein after the microparticles
`are suspended in that vehicle, they are quickly frozen, and lyophilized. Id. at
`37:5‒9. For injection into dogs, the “dry microparticles were syringe-loaded
`and resuspended in the syringe with an injection vehicle comprised of 2.5
`wt% carboxymethyl cellulose (CMC).” Id. at 38:6‒8.
`iii. Overview of Kino (Ex. 1010)
`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
`
`
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`
`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. In addition, according
`to Kino, the sustained release injection may be made more stable by adding
`a filler such as sorbitol or mannitol, drying to form a solid preparation,
`which is then used by adding a dispersion medium, such as water, before
`injection. Id. at 4:52‒60.
`
`Kino teaches also that 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.
`
`iv. Overview of U.S. Pharmacopeia (Ex. 1006)
`The U.S. Pharmacopeia discusses carboxymethyl cellulose sodium,
`
`and discusses methods of determining its viscosity. Ex. 1006, 274‒275.
`The U.S. Pharmacopeia discusses also methods of measuring viscosity
`generally. Id. at 1840.
`
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`
`Overview of European Pharmacopoeia (Ex. 1007)
`v.
`The European Pharmacopoeia discusses carboxymethyl cellulose
`
`sodium, and discusses methods of determining its viscosity. Ex.1007, 547.
`vi.
`Analysis
`Petitioner relies on Goldenheim as it did in its anticipation challenge.
`Pet. 34‒35, 43‒44. Petitioner contends “[t]o the extent that Goldenheim’s
`disclosure of the temperature at which viscosity is measured is not
`considered inherent or within the knowledge of the [ordinary artisan], then
`the U.S. Pharmacopoeia and the European Pharmacopoeia explicitly disclose
`that information and render these claims obvious.” Id. at 35‒36; see also id.
`at 45 (noting that the combination of Goldenheim “with the U.S. and
`European Pharmacopoeias teaches all of the elements of claim 1”).
`
`Petitioner has not explained, however, how the additionally cited
`references remedy the deficiencies discussed above with respect to the
`anticipation rejection. As the Supreme Court pointed out in KSR Int’l Co. v.
`Teleflex Inc., 550 U.S. 398 (2007), “a patent composed of several elements
`is not proved obvious merely by demonstrating that each of its elements was,
`independently, known in the prior art.” Id. at 418. Rather, the Court stated:
`[I]t can be important to identify a reason that would have
`prompted a person of ordinary skill in the relevant field to
`combine the elements in the way the claimed new invention does
`. . . because inventions in most, if not all, instances rely upon
`building blocks long since uncovered, and claimed discoveries
`almost of necessity will be combinations of what, in some sense,
`is already known.
`
`Id. at 418-419 (emphasis added); see also id. at 418 (requiring a
`determination of “whether there was an apparent reason to combine the
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`
`known elements in the fashion claimed by the patent at issue”) (emphasis
`added).
`In the instant proceeding, Petitioner has not provided a reason,
`however, as to why the ordinary artisan would have taken Goldenheim’s one
`mention of a viscosity of 35 cp and applied it to the formulation in Example
`16 relied upon by Petitioner to meet the concentration limitation of
`independent challenged claim 1. Specifically, as noted by Patent Owner
`(Prelim. Resp. 20), Goldenheim teaches that “[i]n certain instances, the final
`reconstituted product viscosity may be, e.g., about 35 cps” (Ex. 1004, 35:11)
`but does not explain what those instances may be, much less tying that
`disclosure to the concentration of microparticles used in Example 16, which
`makes no mention of viscosity.
`Thus, after considering the Petition and Preliminary Response, we
`determine that Petitioner has not sufficiently established a reasonable
`likelihood that claims 1‒13 and 17‒23 are rendered obvious by the cited
`prior art.
`
`
`CONCLUSION
`For the foregoing reasons, we are not persuaded that the Petition
`establishes a reasonable likelihood that Petitioner would prevail in showing
`claims 1–13 and 17‒23 patent are unpatentable under either 35 U.S.C. § 102
`or 35 U.S.C. §103.
`
`
`ORDER
`In consideration of the foregoing, it is
`ORDERED that the Petition is DENIED and no trial is instituted.
`
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`
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`IPR2016-01095
`Patent 6,667,061 B2
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`PETITIONER:
`
`William Mentlik
`Paul Kochanski
`Tedd Van Buskirk
`Nichole Valeyko
`LERNER, DAVID, LITTENBERG, KRUMHOLZ & MENTLIK, LLP
`wmentlik.ipr@ldlkm.com
`pkochanski@ldlkm.com
`tvanbuskirk@ldlkm.com
`nvaleyko@ldlkm.com
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`
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`PATENT OWNER:
`
`Scott Reed
`Justin Oliver
`FITZPATRICK, CELLA, HARPER & SCINTO
`alkermesipr@fchs.com
`joliver@fchs.com
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`
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`16
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