Trials@uspto.gov
`571-272-7822
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` Paper 28
`Entered: December 27, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DERMIRA, INC.,
`Petitioner,
`
`v.
`
`PUREPHARM, INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01594
`Patent 8,252,316 B2
`____________
`
`
`Before LORA M. GREEN, DEBORAH KATZ, and ZHENYU YANG,
`Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`571-272-7822
`
`
`
`
`
`
` Paper 28
`Entered: December 27, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DERMIRA, INC.,
`Petitioner,
`
`v.
`
`PUREPHARM, INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01594
`Patent 8,252,316 B2
`____________
`
`
`Before LORA M. GREEN, DEBORAH KATZ, and ZHENYU YANG,
`Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`IPR2015-01594
`Patent 8,252,316 B2
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`INTRODUCTION
`Dermira, Inc. (“Petitioner”) filed a Petition (Paper 1 (“Pet.”)), seeking
`an inter partes review of claims 1–8 of U.S. Patent No. 8,252,316 B2 (“the
`’316 patent,” Ex. 1004). On January 7, 2016, the Board instituted a review
`of the patentability of the challenged claims. Paper 6 (“Dec.”). Thereafter,
`Purepharm, Inc. (“Patent Owner”) filed a Response (Paper 15 (“PO Resp.”)),
`and Petitioner filed a Reply (Paper 25).
`The Board has jurisdiction under 35 U.S.C. § 6 and issues this final
`written decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For
`the reasons provided below, we conclude Petitioner has established by a
`preponderance of the evidence that claims 1–3 and 5–8 of the ’316 patent are
`unpatentable. Petitioner, however, has failed to meet its burden of proof
`regarding the unpatentability of claim 4.
`Related Proceedings
`Petitioner also filed IPR2015-01593, seeking an inter partes review of
`U.S. Patent No. 8,679,524 B2, a patent in the same family as the ’316 patent.
`Pet. 1. We instituted trial in that case, and issue a final decision therein
`concurrently with this Final Written Decision. See Dermira, Inc. v.
`Purepharm, Inc., Case IPR2015-01593 (PTAB Dec. 27, 2016) (Paper 28).
`The ’316 Patent
`The ’316 patent relates to a method of topically applying
`glycopyrrolate to reduce excessive sweating in localized areas for those who
`suffer from the condition. Ex. 1004, 1:11–14.
`Before the invention of the ’316 patent, using topical glycopyrrolate
`to reduce excessive sweating had been known for two decades. Id. at 1:25–
`3:2. According to the ’316 patent, however, “[u]sing the previously
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`available delivery methods, the topical application of glycopyrrolate can be
`messy and inconvenient.” Id. at 3:60–62. The ’316 patent discloses “a pad
`containing an amount of glycopyrrolate in solution, for topical application of
`a therapeutically effective amount of glycopyrrolate, which is useful in
`reducing sweating in humans.” Id. at 3:6–9.
`Illustrative Claim
`Claim 1 is the only independent claim. It reads:
`1. A method of reducing sweating by applying a dosed amount
`of glycopyrrolate solution to effect the topical application of a
`therapeutically effective amount of glycopyrrolate to a part of the
`human body, with the exception of mucous membranes, so as to
`reduce sweating on said part of the human body, the dosed
`amount of glycopyrrolate solution contained in an absorbent pad
`applied to said part of the human body and made of a material
`capable of containing the dosed amount for application, wherein
`said amount of glycopyrrolate in solution is an amount ranging
`from 3.0 wt. % to 4 wt. %.
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`3
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`Reviewed Grounds of Unpatentability
`The Board instituted trial to review the following grounds of
`unpatentability:
`Reference(s)
`Basis
`Claims
`Hays1
`§ 102
`1 and 2
`Bobrove2 and Bodor3
`§ 103
`1, 2, 4, 5, and 8
`Bobrove and Thaman4
`§ 103
`3 and 6–8
`Patent Owner notes that we did not address claim 7 in the Decision to
`Institute and thus “it is presumed that this claim is deemed to be patentable
`over the prior art relied upon by the Petitioner.” PO Resp. 1. This statement
`is incorrect. As Patent Owner acknowledges, we instituted to review, among
`other grounds, whether “claims 3 and 6–8” would have been obvious over
`asserted prior art. Id. Claim 7 is subsumed under “claims 6–8.”
`ANALYSIS
`As an initial matter, we emphasize that in an inter partes review, the
`burden of persuasion is on the petitioner to prove unpatentability, and that
`burden never shifts to the patent owner. See 35 U.S.C. § 316(e); Dynamic
`Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir.
`
`
`1 Leonard L. Hays, The Frey Syndrome: A Review and Double Blind
`Evaluation of the Topical Use of a New Anticholinergic Agent, 88 THE
`LARYNGOSCOPE 1796–1824 (1978) (Ex. 1009, “Hays”).
`2 Bobrove et al., U.S. Patent No. 5,962,505, issued Oct. 5, 1999 (Ex. 1008,
`“Bobrove”).
`3 Nicholas Bodor, U.S. Patent No. 4,824,676, issued Apr. 25, 1989
`(Ex. 1030, “Bodor”).
`4 Thaman et al., U.S. Patent No. 4,891,227, issued Jan. 2, 1990
`(Ex. 1010, “Thaman”).
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`2015). Thus, we do not hold the challenged claims unpatentable simply
`because, as Petitioner alleges, Patent Owner has not taken certain actions.
`See Reply 8–9 (stating, for example, that Patent Owner did not take the
`deposition of the witness for Petitioner, and did not offer any expert
`testimony in support of its own argument). Instead, we analyze the entire
`record developed during trial in analyzing the patentability of the challenged
`claims.
`
`Claim Construction
`In an inter partes review, the Board interprets a claim term in an
`unexpired patent according to its broadest reasonable construction in light of
`the specification of the patent in which it appears. 37 C.F.R. § 42.100(b);
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under
`that standard, and absent any special definitions, we assign claim terms their
`ordinary and customary meaning, as would be understood by one of ordinary
`skill in the art at the time of the invention, in the context of the entire patent
`disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007).
`In the Decision to Institute, we determined that under the broadest
`reasonable interpretation, “dosed amount,” as recited in claim 1, is not
`limited by the volume of the glycopyrrolate solution. Dec. 6. Similarly, we
`concluded that an “absorbent pad” is not limited by the volume of the
`glycopyrrolate solution it absorbs. Id. Patent Owner challenges our
`interpretations as rendering “the term[s] ‘dose’ and ‘solution’ [to] have
`absolutely no meaning in the claim whatsoever.” PO Resp. 4. Patent Owner
`appears to refer to its arguments presented in the Preliminary Response
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`(Paper 5 (“Prelim. Resp.”)). See, e.g., PO Resp. 8. Our Rule does not allow
`incorporating by reference arguments from one document into another. 37
`C.F.R. § 42.6(a)(3). For purposes of this Decision, we nevertheless consider
`Patent Owner’s position that the term “‘[d]osed amount’ refers to a specific
`predetermined unitized amount to be applied for the purpose of reducing
`sweating.” See Prelim. Resp. 19.5 According to Patent Owner, “an amount
`of glycopyrrolate in concrete units” is determined by “the concentration . . .
`multiplied by the volume of the solution.” Id. at 23–24. We, again, reject
`Patent Owner’s argument.
`In interpreting claim terms, the claims themselves provide substantial
`guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.
`Cir. 1996). Here, claim 1, from which claims 2–8 depend, recites the dosed
`amount of glycopyrrolate in solution as “an amount ranging from 3.0 wt. %
`to 4 wt. %.” Because claim 1 describes the dosed amount by the
`strength/concentration, it supports our conclusion that term “dosed amount”
`is not limited by the volume of the glycopyrrolate solution.
`When conducting claim construction, we also rely heavily on the
`written description for guidance as to the meaning of the claims. In re
`Translogic Tech., 504 F.3d at 1257. The Specification of the ’316 patent
`does not employ the term “dosed amount.” In fact, the term “dose” only
`
`
`5 Even in the Preliminary Response, Patent Owner did not present a clear
`interpretation of the term “absorbent pad.” Instead, Patent Owner merely
`repeated the claim language that the absorbent pad is “one made of a
`material capable of containing the dosed amount for application.” See
`Prelim. Resp. 21.
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`appears once in the written description, and in that context, it does not
`inform us of the meaning of “dosed amount.” See Ex. 1004, 4:59–60
`(stating “the patient may not wish to increase the oral dose”). According to
`Patent Owner, however, the ’316 patent “speaks of a concentration of the
`glycopyrrolate in the solution (0.25% to 6%, particularly 1, 2, or 3%) and a
`mass amount in terms of mg, greater than 2.5 milligrams to not more than 60
`milligrams.” PO Resp. 9 (citing Ex. 1004, 3:5–15) (emphasis added). We
`disagree.
`Contrary to Patent Owner’s assertion, in describing the amount of
`glycopyrrolate in solution, the Specification excerpt Patent Owner relies on
`uses the disjunctive “or,” and not the additive “and,” to connect the
`concentration and the mass amount. See Ex. 1004, 3:10–14 (stating “the
`amount of glycopyrrolate in solution is greater than 0.25% and not more
`than 6%, particularly 1%, 2% or 3% glycopyrrolate, or greater than 2.5
`milligrams and not more than 60 milligrams of glycopyrrolate” (emphasis
`added)). The transposable usage of the strength/concentration and the
`weight to describe the amount of glycopyrrolate in solution in the
`Specification confirms our determination that the term “dosed amount,” as
`used in the ’316 patent, is not limited by the volume of the glycopyrrolate
`solution.
`In addition, the ’316 patent discloses:
`A concentration of glycopyrrolate greater than 0.1% is desirable
`since 0.1% has been shown to be ineffective. A 1%
`glycopyrrolate solution was initially chosen for testing purposes.
`However, the range of glycopyrrolate can vary to meet the needs
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`of the patient. The upper limit could be at least as high as 6%,
`although mild side effects begin to present themselves after 4%.
`Id. at 5:47–6:4 (internal citations omitted). According to the ’316 patent,
`although “[m]ost patients enjoy effective control of sweating using the
`regular strength of 2% glycopyrrolate,” “topical glycopyrrolate should be
`made in the range of a 0.25% to 6% solution to deal with individual
`variability.” Id. at 8:19–25. In other words, when discussing the
`effectiveness of glycopyrrolate in reducing sweating, the ’316 patent only
`refers to the strength/concentration, and not the volume, of the solution, or
`the weight of glycopyrrolate applied. See also id. at 8:26–9:3 (describing
`treating patients with pads containing 1%, 1.5%, 2%, and 3% glycopyrrolate
`solutions, without mentioning the volume applied).
`Patent Owner points out the ’316 patent describes several pads, each
`of which holds a specific volume of the glycopyrrolate solution with a
`predetermined weight of glycopyrrolate. PO Resp. 9–10 (citing Ex. 1004,
`6:45–7:5 (the pad holds one milliliter of solution with 10 mg of
`glycopyrrolate); 3:15–18, 35–45 (the pad holds one milliliter of a 2%
`glycopyrrolate solution). According to Patent Owner, these embodiments
`demonstrate that a “dosed amount” is “a predetermined unitized amount of
`glycopyrrolate . . . to be administered to a patient to reduce sweating without
`the risk of providing the patient with too much of the drug.” PO Resp. 10.
`We are not persuaded.
`Although “it is entirely proper to use the specification to interpret
`what the patentee meant by a word or phrase in the claim . . . this is not to be
`confused with adding an extraneous limitation appearing in the specification,
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`which is improper.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`Thus, we decline to import the volume of the glycopyrrolate solution or
`weight of glycopyrrolate from specific embodiments and narrow our
`interpretation of the term “dosed amount.”
`In its Preliminary Response, Patent Owner relied on the dictionary
`definition of “dose.” Prelim. Resp. 19–20 (citing Ex. 2007) (stating dose
`means “the quantity to be administered at one time, such as a specified
`amount of medication”). In its Response, Patent Owner alleges that in the
`Decision to Institute, we erred in not commenting on the dictionary
`definition it offered. PO Resp. 8. In support of its position, Patent Owner
`relies on PPC Broadband, Inc. v. Corning Optical Communications RF,
`LLC, 815 F.3d 747 (Fed. Cir. 2016). PO Resp. 8. Even if we adopt Patent
`Owner’s reading of that case in its entirety, however, PPC appears to stand
`for exactly the opposite of Patent Owner’s argument. Indeed, according to
`Patent Owner, in PPC, the Federal Circuit concluded that the Board
`unreasonably relied on a dictionary definition in claim construction, and
`“failed to account for how the claims themselves and the specification
`inform the ordinary skilled artisan as to precisely which ordinary definition
`the patentee was using.” Id. at 7–8. It is unclear how, in this case, our
`analyses based on the claim language and the specification, and not the
`dictionary definition, runs afoul of the established law on claim construction.
`Moreover, although extrinsic evidence, such as dictionaries, may be
`useful, “it is unlikely to result in a reliable interpretation of patent claim
`scope unless considered in the context of the intrinsic evidence,” including
`the claims and the specification. In re Hiok Nam Tay, 579 F. App’x 999,
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`1000 (Fed. Cir. 2014) (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1319
`(Fed. Cir. 2005) (en banc)). Thus, we may consider such evidence only if
`“the dictionary definition does not contradict any definition found in or
`ascertained by a reading of the patent documents.” Phillips, 415 F.3d at
`1322–23. Here, assuming, without deciding, that the dictionary definition
`supports Patent Owner’s argument, it cannot override our conclusion based
`on the intrinsic evidence.
`As a result, we determine that, under the broadest-reasonable-
`interpretation standard, “dosed amount,” as recited in claim 1, is not limited
`by the volume of the glycopyrrolate solution. And because an absorbent pad
`is “one made of a material capable of containing the dosed amount for
`application,” we similarly determine that an “absorbent pad” is not limited
`by the volume of the glycopyrrolate solution it absorbs. These
`determinations as to the scope of “dosed amount” and “absorbent pad” are
`sufficient for purposes of this Decision, and we need not further address the
`two terms.
`
`Anticipation by Hays
`Petitioner asserts that Hays discloses each and every limitation of
`claims 1 and 2. Pet. 24–32. In support of its patentability challenge,
`Petitioner relies on the Declaration of Dr. Richard H. Guy (Ex. 1003). After
`reviewing the entire record, we determine that Petitioner has established by a
`preponderance of the evidence that claims 1 and 2 are anticipated by Hays.
`Hays discloses that “[g]lycopyrrolate is effective in both a distilled
`water base and a vanishing cream base in 0.5 to 1% concentration. It
`completely controls gustatory sweating for several days or more.” Pet. 30
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`(citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should
`be carefully applied while avoiding the mouth, nose, and eyes. Id. (citing
`Ex. 1009, 1798, 1809). For example, it discloses applying a cotton
`applicator dipped in the glycopyrrolate solution to the skin while holding the
`hair up out the way to treat patients with gustatory sweating in the hairline.
`Id. at 31 (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan
`would have understood the cotton applicator in Hays “as being any of a
`cotton ball, a cotton pad, a cotton swab, or having a cotton component as a
`part of a larger applicator.” Ex. 1003 ¶ 72. According to Hays,
`glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided
`effective control of gustatory sweating with no significant side effects. Pet.
`29 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays
`discloses each and every limitation of claim 1.
`Patent Owner counters that the cotton applicator of Hays is not the
`same as the absorbent pad recited in claim 1 because (1) Hays provides no
`specifications for the applicator; (2) Hays does not control the amount of
`glycopyrrolate in the applicator; and (3) Hays does not control the number of
`applications a patient can apply. PO Resp. 12. We are not persuaded by
`Patent Owner’s arguments.
`Claim 1 recites an absorbent pad that is “made of a material capable
`of containing the dosed amount of glycopyrrolate solution for application.”
`It does not specify the types of materials the pad is made of. We note that,
`claim 8, which depends from claim 1, further recites “the absorbent pad is a
`non-cotton absorbent pad.” As a result, we conclude that the absorbent pad
`recited in claim 1 can be made of either cotton or non-cotton material. See
`11
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`Karlin Tech. Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 971–72 (Fed.
`Cir. 1999) (explaining that generally, a limitation in a dependent claim
`should not be read into the independent claim from which it depends). In
`Hays, the applicator is made of cotton and saturated with glycopyrrolate
`solution. It is of little consequence that Hays does not provide other
`descriptions, including a specific manufacturer, of the cotton applicator. See
`PO Resp. 12 (arguing “[n]o manufacturer is stated and the applicator is not
`described” in Hays).
`In addition, as explained above, the claimed dosed amount is not
`limited by the volume of glycopyrrolate solution. Instead, claim 1 recites
`that the “amount of glycopyrrolate in solution is an amount ranging from 3.0
`wt. % to 4 wt. %,” and that the amount is therapeutically effective so as to
`reduce sweating of the body part treated. In Hays, the cotton applicator,
`saturated with 1.0% and up to 4% glycopyrrolate solution, provided
`complete control of gustatory facial sweating. Ex. 1009, 1807, 1819. Thus,
`the cotton applicator in Hays satisfies the “made of a material capable of
`containing the dosed amount of glycopyrrolate solution for application,” as
`required in claim 1.
`Patent Owner also contends that the cotton applicator of Hays is not
`the same as the absorbent pad recited in claim 1 because the glycopyrrolate
`solution in Hays is not uniform. PO Resp. 14–15. Referring to Hays 19826
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`6 Hays et al., The Frey Syndrome: A Simple, Effective
`Treatment, 90 OTOLARYNGOL. HEAD NECK SURG. 419–25 (1982) (Ex. 1014,
`“Hays 1982”).
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`and Kalaria declarations submitted during the prosecution,7 Patent Owner
`contends that glycopyrrolate forms aggregates when in solution. Id. at 14,
`29–41. As a result, Patent Owner argues, because the aggregates sink to the
`bottom of a container, in Hays, the cotton applicator dipped into the solution
`may contain very little glycopyrrolate. Id. at 14–15. We are not persuaded.
`In Hays 1982, “[r]oll-on solutions in which the concentration to
`glycopyrrolate exceeded 2% caused crystals.” Ex. 1014, 421. In addition,
`Kalaria allegedly observed glycopyrrolate-containing solutions can form
`crystals at concentrations in the range of the 2–6%. Ex. 1021 ¶¶ 9, 13.
`According to Patent Owner, “[t]hese observations can be explained by the
`micellar formation of anticholinergic drugs as described in At[t]wood.”8 PO
`Resp. 31. Patent Owner relies on Attwood for the proposition that “all
`anticholinergics generally, and glycopyrrolate specifically, form aggregates
`when in solution.” Id. at 14. Attwood states, as Patent Owner repeatedly
`emphasizes, “[a]ll of the compounds studied showed some degree of
`aggregation, with scattering intensities in excess of those calculated for
`monomers.” Ex. 1034, 1985; see, e.g., PO Resp. 27, 37, 38 (quoting Ex.
`1034, 1985). One of the compounds studied in Attwood is glycopyrronium
`bromide (IIIa), i.e., glycopyrrolate. Ex. 1034, 1984. According to Attwood,
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`7 Declaration under 37 C.F.R. 1.132, executed by Dipen Kalaria on June 29,
`2009 (Ex. 1021), and Supplemental Declaration under 37 C.F.R. 1.132,
`executed by Dipen Kalaria on November 12, 2010 (Ex. 1022).
`8 D. Attwood, Micellar and Nonmicellar Association of
`Antiacetylcholine Drugs in Aqueous Solution, 80 JOURNAL OF
`PHYSICAL CHEMISTRY 1984–87 (1976) (Ex. 1034, “Attwood”).
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`the critical micellar concentration for glycopyrrolate is 0.189 mol/kg, i.e.,
`7.5% of glycopyrrolate. Ex. 1034, 1986; see also Prelim. Resp. 12–13
`(converting glycopyrrolate concentration from mol/kg into %).
`Attwood states that the scattering curves of glycopyrrolate (IIIa) and
`some other compounds “showed abrupt changes of slope over narrow, well-
`defined concentration regions. At concentrations below the critical
`concentration, the scattering of such compounds did not deviate significantly
`from that calculated for unassociated monomers.” Ex. 1034, 1985. Because
`the glycopyrrolate solutions tested in the Declarations of Kalaria are up to
`6% (Exs. 1021, 1022), below 7.5%, the critical micellar concentration for
`glycopyrrolate, we are not persuaded that the crystals allegedly observed
`were due to the concentration of glycopyrrolate in solution. Similarly,
`because Hays examined “up to 4% glycopyrrolate” solution (Ex. 1009,
`1819), below 7.5%, the critical micellar concentration for glycopyrrolate, we
`are not persuaded that the glycopyrrolate solution in Hays is not uniform.
`As a result, we conclude that the cotton applicator in Hays satisfies the
`“made of a material capable of containing the dosed amount of
`glycopyrrolate solution for application,” as required in claim 1.
`Hays discloses applying the cotton applicator saturated with the
`glycopyrrolate solution to a mapped area affected by gustatory facial
`sweating. Ex. 1009, 1807. Thus, Hays satisfies “wherein the part of the
`human body comprises one or both of the face and the groin,” as recited in
`claim 2.
`In sum, Petitioner has established by a preponderance of the evidence
`that Hays discloses each and every limitation of claims 1 and 2.
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`Obviousness over Bobrove, Bodor, and Thaman
`Petitioner asserts that claims 1, 2, 4, 5, and 8 would have been
`obvious over the combination of Bobrove and Bodor, and that claims 3 and
`6–8 would have been obvious over the combination of Bobrove, Bodor, and
`Thaman. Pet. 32–53. After reviewing the entire record, we determine that
`Petitioner has established obviousness of claims 1–3 and 5–8 by a
`preponderance of the evidence. Petitioner, however, has failed to meet its
`burden of proof regarding the unpatentability of claim 4.
`Level of Ordinary Skill
`The parties disagree over the level of ordinary skill.9 See Pet. 17–18;
`PO Resp. 3; Reply 9. For purposes of this Decision, we do not need to
`resolve this dispute because the prior art itself reflects an appropriate skill
`level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).
`Patent Owner also argues that Dr. Guy, Petitioner’s declarant, does
`not qualify as one of ordinary skill in the art because he is not a clinician,
`physician, or pharmacist. PO Resp. 3. We disagree with Patent Owner on
`this issue. All asserted references relate to topical administration of
`pharmaceutical compositions. See, e.g., Ex. 1008, 4:1; Ex. 1010, 2:35–38;
`Ex. 1030, 3:60–61. In addition, the challenged ’316 patent relates to the
`topical delivery of glycopyrrolate to reduce excessive sweating and
`minimize side effects. Ex. 1004, Abstract, 1:12–20. Dr. Guy has over 30
`years of experience in fields including topical drug delivery, transdermal
`
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`9 We note that Patent Owner’s position is only attorney argument,
`unsupported by evidence.
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`drug delivery, prediction and assessment of skin penetration, and topical
`drug bioavailability. Ex. 1003 ¶¶ 3, 6, 7, Appendix A. We determine that
`Dr. Guy has exceeded the level of ordinary skill in this case, and thus,
`accord proper weight to his testimony.
`Patent Owner also asks the Board to give no weight to the Guy
`Declaration because of alleged factual errors. PO Resp. 22. We will address
`the facts asserted by Dr. Guy and the support to which he cites as
`appropriate in this Decision.
`Claims 1 and 2
`Bobrove and Bodor each teaches a method of reducing sweating by
`applying a glycopyrrolate solution to a part of the human body. For
`example, Bobrove teaches topically administering glycopyrrolate
`compounds to treat hot flashes and the perspiration associated therewith.
`Ex. 1008, 5:29–32. Bodor teaches transdermal delivery of an anticholinergic
`agent, including glycopyrrolate, in an amount sufficient to have a local anti-
`secretory effect on skin. Ex. 1030, 1:10–17, 9:18–28, 16:34.
`In Bobrove, glycopyrrolate is applied to the skin surface to be treated,
`preferably the face, including the cheeks, neck, and forehead, taking care to
`avoid eyes, nose, and mouth, as recited in claims 1 and 2. Ex. 1008, 5:33–
`39, see also id. at 4:1–10 (stating glycopyrrolate is administered topically to
`areas including the face and groin). Bobrove teaches applying
`glycopyrrolate using a roll-on applicator. Id. at 6:12–13, 26–27, 37–39.
`Although Bobrove does not explicitly teach “an absorbent pad,” it
`teaches topical glycopyrrolate compositions in the forms of suspensions,
`emulsions, solutions, alcoholic solutions, and ointments. Id. at 4:53–55.
`16
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`IPR2015-01594
`Patent 8,252,316 B2
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`According to Petitioner, absorbent pads would have been a well-known and
`predictable method for the topical application of drugs in these forms to the
`skin. Pet. 34 (citing Ex. 1003 ¶¶ 16–19). We agree. Whether an ordinary
`artisan is one with a degree in chemistry, biopharmaceutical science,
`pharmacy, or pharmaceutical science and years of experience and technical
`training, as Petitioner contends (see Pet. 17–18), or a clinician, physician, or
`pharmacist with knowledge and experience in the treatment of hyperhidrosis
`in humans, as Patent Owner argues (see PO Resp. 3), such a person would
`have known to use an absorbent pad for applying a topical composition. See
`KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007) (“A person of
`ordinary skill is also a person of ordinary creativity, not an automaton.”).
`Moreover, Bodor specifically teaches “an absorbent pad.” According
`to Bodor, the anticholinergic agent, including glycopyrrolate, can be placed
`onto an applicator such as a cotton swab or cloth, and the applicator is then
`rubbed on the skin. Ex. 1030, 15:5–9, 15:39–42 (stating the anticholinergic
`agent can be “absorbed on an applicator such as a piece of cotton cloth or
`other suitable soft pliable material”).
`Patent Owner counters that neither Bobrove nor Bodor teaches the
`concept of applying a dosed amount of a glycopyrrolate in an absorbent pad
`for treating sweating. PO Resp. 17. We are not persuaded. As explained
`above, we determine that “dosed amount,” as recited in the challenged
`claims, is not limited by the volume of the glycopyrrolate solution. Here,
`Bobrove teaches topical solutions with about 0.05% to 5.0% of
`glycopyrrolate. Ex. 1008, 4:39–44. In other words, Bobrove teaches the
`amount of glycopyrrolate in a range encompassing the range recited in claim
`17
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`IPR2015-01594
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`1. Thus, a preponderance of the evidence supports Petitioner’s argument
`that the combination of Bobrove and Bodor teaches each and every
`limitation of claims 1 and 2. See Pet. 33–36, 38–44.
`Next, we determine whether Petitioner has demonstrated that one of
`ordinary skill in the art would have had a reason to combine the teachings of
`Bobrove and Bodor. Petitioner asserts that an ordinary artisan would have
`had a reason to combine Bobrove with Bodor. Pet. 33–35; Reply 19–20.10
`Patent Owner disagrees. PO Resp. 18–19. According to Patent Owner,
`Bodor addresses “insensible perspiration of human skin,” an issue different
`from hyperhidrosis, the subject of Bobrove. Id. at 18. Thus, Patent Owner
`argues, “Bodor has nothing to do with . . . a method that applies a
`therapeutically effective amount of glycopyrrolate to reduce sweating.” Id.
`We find Petitioner’s argument more persuasive.
`Patent Owner is correct that Bodor, in one aspect, relates to an
`improved transdermal delivery system. Ex. 1030, 3:63–65. A separate,
`independent object of Bodor, however, is “to deliver, to an area of skin, an
`anticholinergic agent in an amount sufficient to have a local antisecretory
`effect on the area of skin.” Ex. 1030, 3:66–4:1. Similarly, Bobrove aims to
`treat perspiration associated with hot flashes with transdermal application of
`glycopyrrolate. Ex. 1008, 2:52–55. Thus, both Bobrove and Bodor teach
`methods of reducing sweating with glycopyrrolate.
`
`
`10 In the Reply, Petitioner cites to Exhibit 1011, a U.S. patent also issued to
`Bobrove. Reply 19–20. Exhibit 1011 is unrelated to Exhibit 1008
`(“Bobrove”), on which we instituted this trial. Nevertheless, the teachings
`of Exhibit 1011 that Petitioner relies on are also disclosed in Bobrove.
`18
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`IPR2015-01594
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`Bobrove specifically teaches applying a “roll on” glycopyrrolate
`solution. Ex. 1008, 6:26–27, 6:36–37. It, however, also generally teaches
`that glycopyrrolate is administered topically. Id. at 4:1. Thus, one of
`ordinary skill in the art would have had a reason to look for other means to
`apply glycopyrrolate. As Dr. Guy testifies, “[t]here are a limited number of
`ways to topically deliver a drug to a patient’s skin.” Ex. 1003 ¶ 16. In
`addition, Bobrove suggests to avoid the eyes, nose, and mouth during the
`topical administration. Ex. 1008, 5:37–39. Given these considerations,
`Bodor provides an effective alternative: a cotton cloth to absorb the drug and
`rub it on the skin. Ex. 1030, 15:39–54; see also Ex. 1003 ¶ 17 (explaining
`that, at the time of the invention, an ordinary artisan would have known that
`use of medicated pads “allowed for topical application of a solution, for
`example to a subject’s face, while excluding application to sensitive areas
`such as the eyes or mucous membranes”). Thus, we conclude Petitioner has
`shown, by a preponderance of the evidence, that an ordinary artisan would
`have had a reason to combine the teachings of Bobrove and Bodor.
`In sum, Petitioner has shown, by a preponderance of the evidence, that
`an ordinary artisan would have had a reason to combine the teachings of
`Bobrove and Bodor, and that the combination teaches each and every
`limitation of claims 1 and 2.
`Claims 4, 5, and 8
`Claim 4 depends from claim 1 and further recites that “the applying
`step [of claim 1] is performed in combination with the administration of
`another oral and/or topical therapy for reduction of sweating.” Petitioner
`contends that Bodor suggests this additional limitation. Pet. 36–37.
`19
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`IPR2015-01594
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`Bodor teaches that the application of an anticholinergic, such as
`glycopyrrolate, “to prevent perspiration and thus indirectly enhance
`transdermal delivery of a pharmaceutically active, preferably non-
`anticholinergic, drug.” Ex. 1030, 3:41–46. Petitioner emphasizes that
`although Bodor prefers, it does not require, the second drug to be non-
`anticholinergic. Pet. 37; Reply 21–22. According to Petitioner, this
`preference does not amount to teaching away from a non-preferred
`embodiment. Pet. 36; Reply 21. Because the second drug in Bodor broadly
`includes “transdermally deliverable physiologically or pharmacologically
`active substances,” Petitioner argues, Bodor encompasses “anticholinergic
`drugs, even if non-preferred, as an add
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