Paper: 13
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`Trials@uspto.gov
`Tel: 571-272-7822 Entered: July 24, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`COMPLEX INNOVATIONS, LLC,
`Petitioner,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`_______________
`
`Case IPR2017-00631
`Patent 7,759,328 B2
`_______________
`
`
`Before ERICA A. FRANKLIN, SUSAN L.C. MITCHELL, and
`ZHENYU YANG, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`Trials@uspto.gov
`Tel: 571-272-7822 Entered: July 24, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`COMPLEX INNOVATIONS, LLC,
`Petitioner,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`_______________
`
`Case IPR2017-00631
`Patent 7,759,328 B2
`_______________
`
`
`Before ERICA A. FRANKLIN, SUSAN L.C. MITCHELL, and
`ZHENYU YANG, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
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`IPR2017-00631
`Patent 7,759,328 B2
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`I. INTRODUCTION
`Complex Innovations, LLC (“Petitioner”) filed a Petition (Paper 2;
`“Pet.”) to institute an inter partes review of claims 1−15 of US 7,759,328 B2
`(Ex. 1001; “the ’328 patent”). Astrazeneca AB (“Patent Owner”) filed a
`Patent Owner Preliminary Response. Paper 9 (“Prelim. Resp.”). Upon
`request, we authorized Petitioner to file a Reply to Patent Owner’s
`Preliminary Response, and we authorized Patent Owner to file a Sur-Reply.
`Paper 10. Each of those authorized filings was limited to a discussion of the
`canister fill weights asserted by Petitioner’s declarant. Paper 11 (“Reply”)
`and Paper 12 (“Sur-Reply”).
`We have jurisdiction under 35 U.S.C. § 314, which provides that an
`inter partes review may not be instituted “unless . . . 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(a).
`Upon consideration of the Petition and Preliminary Response, we
`determine that Petitioner has not established a reasonable likelihood that it
`would prevail in showing the unpatentability of at least one challenged
`claim. 35 U.S.C. § 314(a). Accordingly, we deny the Petition and decline to
`institute an inter partes review.
`A. Related Proceedings
`The parties inform us that there are no pending proceedings
`concerning the’328 patent. Pet. 13; Paper 3, 2.
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`B. The ’328 patent
`The ’328 patent discloses pharmaceutical compositions comprising
`formoterol, budesonide, 1,1,1,2,3,3,3-heptafluoropropane (“HFA227”),
`polyvinlypyrrolidone (“PVP”), and polyethylene glycol (“PEG”), along with
`methods of using those formulations in the treatment of respiratory diseases.
`Ex. 1001, 1:14–17, 39–44. Formulations comprising formoterol and
`budesonide were known in the art at the time of the invention. Id. at 1:25–
`26. For example, such a combination has been marketed as Symbicort® in a
`dry powder inhaler. Id. at 1:26–28. The Specification states, however, that
`“[i]t has now been found that certain HFA formulations comprising
`formoterol and budesonide together with polyvinylpyrrolidone (PVP) and
`polyethylene glycol (PEG) exhibit excellent physical suspension stability.”
`Id. at 1:32–35.
`
`C. Illustrative Claims
`Claims 1 and 4 are illustrative of the challenges claims and are
`reproduced below:
`1. A pharmaceutical composition comprising formoterol
`fumarate
`dehydrate,
`budesonide,
`1,1,1,2,3,3,3-
`heptafluoropropane
`(HFA227), PVP K25
`(polyvinlyl
`pyrrolidone with a nominal K-value of 25), and PEG-1000
`(polyethylene glycol with an average molecular weight of 1,000),
`wherein the formoterol fumarate dehydrate is present at a
`concentration of 0.09 mg/ml, the budesonide is present at a
`concentration in the range of 1 mg/ml to 8 mg/ml, the PVP K25
`is present at a concentration of 0.01%w/w, and the PEG-1000 is
`present at a concentration of 0.3% w/w.
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`4. A method of treating symptoms of a respiratory disorder
`comprising administering to a patient the pharmaceutical
`composition according to claim 1, wherein the respiratory
`disorder is asthma, rhinitis, or chronic obstructive pulmonary
`disease (COPD).
`
`
`D. The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1–15 of the ’328
`patent on the following grounds:
`
`
`Reference[s]
`
`Mistry1
`
`Rogueda2
`
`Mistry, Rogueda, and Carling3
`
`Basis
`§ 102
`
`§ 102
`
`§ 103(a)
`
`Claims challenged
`1, 4–15
`
`1, 4–15
`
`1, 4–15
`
`Mistry, Rogueda, Meade,4 and Lewis5 § 103(a)
`
`2, 3
`
`
`Petitioner also relies on the Declaration of Martin Beasley, Ph.D. (Ex. 1012).
`
`
`1 Patent No. US 6,123,924 issued to Suresh N. Mistry et al., Sep. 26, 2000.
`Ex. 1003 (“Mistry”).
`2 Patent Application Publication No. WO 02/03958 A1 by Philippe
`Rogueda, published Jan. 17, 2002. Ex. 1004 (“Rogueda”).
`3 Patent No. US 5,674,860 issued to Christer Cari Gustav Carling et al.,
`Oct. 7, 1997. Ex. 1005 (“Carling”).
`4 Patent Application Publication No. US 2003/0018019 A1 by
`Christopher J.M. Meade et al., published Jan. 23, 2003. Ex. 1007
`(“Meade”).
`5 Patent No. US 8,142,763 issued to David Lewis et al., Mar. 27, 2012.
`Ex. 1008 (“Lewis”).
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`II. ANALYSIS
`A. Claim Construction
` In an inter partes review, the Board interprets claim terms in an
`unexpired patent according to the broadest reasonable construction in light
`of the specification of the patent in which they appear. 37 C.F.R.
`§ 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016)
`(affirming applicability of broadest reasonable construction standard to inter
`partes review proceedings). Under that standard, and absent any special
`definitions, we give 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 re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007). Any special definitions for claim terms must be set forth with
`reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d
`1475, 1480 (Fed. Cir. 1994).
`Petitioner asserts that “the plain and ordinary meaning should apply to
`all claims.” Pet. 26. Patent Owner agrees that “no claim terms require
`express construction.” Prelim. Resp. 1.
`In view of our analysis, we determine that no claim terms require
`express construction for the purpose of this Decision. See Vivid Techs., Inc.
`v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (Only terms
`which are in controversy need to be construed, and only to the extent
`necessary to resolve the controversy).
`B. Anticipation by Mistry
`Petitioner asserts that Mistry anticipates claims 1 and 4–15. Pet. 28–
`36. Patent Owner disagrees. Prelim. Resp. 2–17.
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`“A claim is anticipated only if each and every element as set forth in
`the claim is found, either expressly or inherently described, in a single prior
`art reference.” Verdegaal Bros. v. Union Oil Co. of Cal., 814 F.2d 628, 631
`(Fed. Cir. 1987). “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.” MEHL/Biophile Int'l. Corp. v.
`Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999) (quoting In re Oelrich, 666
`F.2d 578, 581 (CCPA 1981)). Anticipation requires that the prior art
`elements themselves must be “arranged as in the claim,” which means that
`claims cannot be “treated ... as mere catalogs of separate parts, in disregard
`of the part-to-part relationships set forth in the claims and that give the
`claims their meaning.” Lindemann Maschinenfabrik GMBH v. Am. Hoist &
`Derrick Co., 730 F.2d 1452, 1458-59 (Fed. Cir. 1984).
`1. Mistry
`Mistry discloses pressurized aerosol compositions for administering
`inhalation medications. Ex. 1001, 1:7–9. In particular, Mistry’s
`formulations comprise a liquefied hydrofluoroalkane as the aerosol
`propellant, instead of liquefied chlorofluorocarbons (“CFC’s”) believed to
`be responsible for the depletion of the ozone layer in the upper atmosphere.
`Id. at 1:13–46. The Specification states that, previously, “considerable
`difficulties have been encountered in finding suspending agents which are
`soluble in hydrofluoralkanes and capable of stabilizing medicament
`suspensions.” Id. at 1:33–36.
`According to the inventors of Mistry, they have “found that certain
`polymers are both soluble in the aerosol propellants and capable of
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`stabilizing medicament compositions.” Id. at 1:39–41. Such polymers
`include “recurring structural units, the units being selected from amide
`containing units and carboxylic acid ester containing units.” Id. at 1:46–49.
`Mistry especially prefers polyvinylpyrrolidone as the polymer. Id. at 1:61–
`64. Mistry states that it “prefers the polymer to have a K value of from 10 to
`150, more preferably 15–120.” Id. at 2:8–9. Mistry teaches that “[t]he
`amount of the polymer in the composition will depend on the active
`ingredient to be dispersed, its concentration and the particular polymer
`selected. However, in general the amount of polymer is from 0.00001 to
`10% w/w, more preferably 0.001 to 5% w/w and especially 0.001 to 1%
`w/w.” Id. at 2:25–29.
`Mistry teaches that the composition may contain other excipients,
`such as lubricants, especially polyethylene glycol. Id. at 2:30–34. Mistry
`states, “we prefer polyethylene glycol having a mean molecular weight of
`from 200 to 3000, preferably 400 to 2000, eg 1500.” Id. at 2:34–36.
`Mistry discloses three hydrofluoralkanes of interest, with “Propellant
`227” being particularly preferred. Id. at 2:62–65.
`Mistry teaches that drugs dispersed in the composition may include
`any medication conventionally administered to the lung and/or nose by
`inhalation of a pressurized aerosol formulation. Mistry explains,
`Such medicaments include drugs for use in the prophylactic
`or remedial treatment of reversible obstructive airways
`disease, eg drugs such as sodium cromoglycate, nedocromil
`sodium, inhaled steroids, eg beclomethasone dipropionate,
`fluticasone propionate, budesonide and tipredane, and
`bronchodilators, eg salbutamol, reproterol, terbutaline,
`formoterol, pirbuterol, isoprenaline, salmeterol, fenoterol
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`and salts thereof, ad anticholinergic agents such as ipratropium
`bromide, oxitropium bromide and atropine and combinations
`of two or more of these agents, eg a combination
`of a prophylactic agent with a bronchodilator, eg sodium
`cromoglycate with salbutamol.
`
`Id. at 3:31–42.
`Mistry teaches that the amount of the medication in the composition
`will depend upon the nature of the active ingredient and the condition to be
`treated. Id. at 3:62–63. Preferably, the composition “comprises from 0.01 to
`15% w/w, preferably from 0.1 to 10% w/w, and most preferably from 0.5 to
`5% w/w medicament.” Id. at 3:64–67.
` Analysis
`2.
`To show anticipation, Petitioner relies upon Mistry’s broad disclosure
`of a pressurized aerosol composition comprising a number of variable
`components in variable amounts. Because Petitioner has not shown that
`Mistry discloses each and every element as arranged in the challenged
`claims, we do not find that Petitioner has established a reasonable likelihood
`that it would prevail in showing the claims are anticipated. In particular,
`Petitioner asserts that Mistry discloses a pharmaceutical composition
`comprising a combination of formoterol fumarate dehydrate and budesonide
`by disclosing (a) a list of bronchodilators suitable for the composition,
`including formoterol, and salts thereof, (b) a list of drugs used in the
`prophylactic treatment of reversible obstructive airways disease suitable for
`the composition, including budesonide, and (c) that the composition may
`include combinations of the listed drugs. Pet. 29–31. Mistry does not
`expressly disclose a composition comprising formoterol fumarate dehydrate
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`and budesonide. Nor does Petitioner explain persuasively how Mistry’s
`teaching that a combination of any one of the prophylactic agent with any
`one of the bronchodilators listed may be used in the formulation necessarily
`discloses a composition comprising formoterol fumarate dehydrate and
`budesonide.
`With respect to PVP K25, Petitioner asserts that Mistry discloses a
`composition further comprising that element by teaching that “PVP in a
`range of average molecular weights gives acceptable suspensions and that
`PVP with K values are ‘more preferabl[e]’ between 15 and 120.” Pet 31
`(quoting Ex. 1003, 1:65–2:9). Petitioner asserts also that Mistry discloses
`the specific weight percentage of PVP K25 recited by independent claim 1,
`i.e., 0.001%w/w, by teaching that the concentration of the PVP polymer is
`“preferably at least 0.001% w/w,” and “especially 0.001 to 1% w/w.” Id. at
`32 (citing Ex. 1003, 3:10–13, 2:25–29). More precisely, Mistry states that
`“the amount of polymer is from 0.00001 to 10% w/w, more preferably 0.001
`to 5% w/w and especially 0.001 to 1% w/w.” Ex. 1003, 2:25–30. Petitioner
`and Dr. Beasley, however, have not explained how Mistry’s preferred range
`of K values for PVP and preferred concentration for the PVP polymer
`anticipates a claim reciting a composition comprising PVP having a specific
`K value of 25 and a specific weight percentage of 0.001%.
`As discussed in Atofina v. Great Lakes Chemical Corp, 441 F.3d 991
`(Fed. Cir. 2006), “[i]t is well established that the disclosure of a genus in the
`prior art is not necessarily a disclosure of every species that is a member of
`that genus.” Id. at 999 (citing In re Baird, 16 F.3d 380, 382 (Fed. Cir.
`1994)). “There may be many species encompassed within a genus that are
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`not disclosed by a mere disclosure of the genus. On the other hand, a very
`small genus can be a disclosure of each species within the genus.” Id.
`(citing In re Petering, 301 F.2d 676, 682 (1962); Bristol-Myers Squibb Co.
`v. Ben Venue Labs., Inc., 246 F.3d 1368, 1380 (Fed. Cir. 2001)). As
`discussed in OSRAM Sylvania, Inc. v. American Induction Technologies,
`Inc., 701 F.3d 698 (Fed. Cir. 2012), a determination whether a generic
`disclosure necessarily anticipates each species of that genus “depends upon
`the factual aspects of the specific disclosure and particular products at
`issue.” Id. at 705 (quoting Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075,
`1083 (Fed. Cir. 2008)). What is missing from Petitioner’s assertion is some
`persuasive argument based upon the factual aspects of Mistry’s formulation
`disclosure that supports finding that the range of disclosed values necessarily
`anticipates the recited species.
`A similar issue exists for the PEG-100 component of the claimed
`formulation. Petitioner asserts that Mistry discloses PEG-1000 by teaching
`that other ingredients, including excipients intended to improve lubrication,
`such as PEG may be included in the composition. Pet. 32. Petitioner relies
`also upon Mistry’s disclosure of PEG having a broad range of mean
`molecular weights, i.e., “from 200 to 300[0], preferably from 400 to 2000,
`eg 1500” to satisfy the claim requirement of using a PEG having an average
`molecular weight of 1000. Id. (quoting Ex. 1003, 2:31–37). Petitioner
`asserts also that Mistry discloses PEG 1000 in its examples. Pet. 33. Mistry
`explains that the compositions in those examples were prepared to examine
`the effects of different excipients as valve lubricants. Ex. 1003, 11:26–58.
`None of those exemplary compositions, however, include formoterol
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`fumarate dihydrate or budesonide. Nor do those examples include any
`concentration values for PEG-1000. Id. According to Petitioner, Mistry
`discloses the recited 0.3% w/w concentration for PEG-1000 by teaching a
`preferred PEG concentration of 0.01% to 4% w/w, and a more preferred
`concentration of 0.1% w/w to 2% w/w. Pet. 33. Again, Petitioner and Dr.
`Beasley have not explained persuasively why Mistry’s disclosure of a
`composition that may include such a component and disclosing a range of
`values for the component that encompasses the specific value recited for the
`component in the challenged claims is anticipatory.
`As for the required concentrations for each active ingredient,
`Petitioner relies upon Dr. Beasley’s conversion of the recited 0.09 mg/ml of
`formoterol fumarate dihydrate to a weight percentage of 0.015–0.017 %
`w/w. Pet. 29–30 (citing Ex. 1012 ¶ 65). Based on that conversion,
`Petitioner asserts that Mistry discloses the recited specific concentration of
`0.09 mg/ml by teaching a range of 0.01–15% w/w for the medicament. Id.;
`Ex. 1003, 3:27–33, 37, 62–67.
`Beyond the issue of relying upon the disclosure of a broad range of
`values to teach a specific value recited in the challenged claim, without
`providing a persuasive explanation for doing so, Petitioner’s argument is
`also problematic because Dr. Beasley has not supported his calculation
`sufficiently. The conversion relies upon (a) the use of a “standard-size
`canister” between 10 ml and 19 ml, and (b) a person of ordinary skill in the
`art understanding that the total fill weights for such a canister would range
`from 6 grams to 10 grams. Pet. 29; Ex. 1012 ¶ 65. Dr. Beasley, however,
`has not provided any evidence to support those assertions, as Patent Owner
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`has accurately asserted. Prelim. Resp. 9–10: Sur-Reply 1. Nor has he
`explained persuasively how the ranges resulting from his calculations based
`upon those assumptions necessarily disclose the claimed specific
`concentration of formoterol fumarate dihydrate. Moreover, when comparing
`Dr. Beasley’s conversion for the formoterol fumarate dihydrate
`concentration to the disclosure in Mistry, we note that such disclosure relates
`to the total amount of active ingredient(s) included in the composition. Ex.
`1003, 3:64–67. We do not see that Dr. Beasley properly considered that
`teaching, as his opinion appears to rely on Mistry’s disclosed active
`ingredient amount as teaching the amount of formoterol fumarate dihydrate
`alone. For those reasons, we do not afford Dr. Beasley’s conversion
`calculation and testimony regarding the same persuasive weight. See 37
`C.F.R. § 42.65(a); Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756,
`48763 (Aug. 14, 2012) (a declaration expressing an opinion of an expert
`without disclosing underlying facts may be given no weight).
`Thus, upon review of Petitioner’s analysis and declaratory evidence,
`we determine that Petitioner has not established that Mistry discloses each
`and every element as set forth in the claim, either expressly or inherently.
`See Verdegaal Bros., 814 F.2d 628, 631. Rather, Petitioner’s anticipation
`argument with respect to the challenged claims requires picking and
`choosing elements among a catalog of separate parts disclosed by Mistry,
`relying upon a broad disclosure of value ranges to anticipate specific values
`recited by the challenged claims, and relying on an unsupported calculation
`by Dr. Beasley. Accordingly, we determine that Petitioner has not
`established a reasonable likelihood of prevailing in showing that Mistry
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`anticipates any of claims 1 and 4–15. Consequently, we decline to institute
`an inter partes review of any of those claims based on this ground.
`C. Anticipation by Rogueda
`Petitioner asserts that Rogueda anticipates claims 1 and 4–15. Pet.
`36–46. Patent Owner disagrees. Prelim. Resp. 17–27.
`1. Rogueda
`Rogueda discloses a stable pharmaceutical aerosol formulation
`containing a polar fluorinated molecule. Ex. 1004, Abstract. The
`formulation comprises an active substance, an aerosol propellant, a polar
`fluorinated molecule, and an excipient. Id. Rogueda teaches that suitable
`active agents for the formulation include all drugs that can be administered
`via the inhalation route. Id. at 1. “SymbicortTM (budesonide and
`formoterol)” is listed by Rogueda as such a drug that can be formulated into
`the composition. Id. at 2. Rogueda teaches suitable aerosol propellants
`include those known in the art, wherein “P227” is among the two preferred
`such propellants. Id. Rogueda discloses a variety of sample preparations in
`eleven examples, and twelve controls. Id. at 21–26. Each example’s
`samples and control includes either formoterol fumarate dihydrate,
`budesonide, or another active ingredient. Id. Some of the examples, e.g.,
`Examples 8 and 11, include HFA227. None of the examples or controls
`include a combination of formoterol fumarate dihydrate and budesonide, or
`any other combination of active ingredients. Id.
`Rogueda teaches that the excipient in the formulation can be a
`surfactant or a polymer and combinations thereof. Id. at 7. Copolymers are
`particularly favored. Id. Among an extensive list of suitable excipients, id.
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`at 7–9, Rogueda explains that, preferably, the excipient is PEG based, id. at
`9. Rogueda’s list of over 100 such preferred PEG based excipients includes
`PVP K25 and PEG 1000. Id. Rogueda also teaches that other ingredients,
`for example other co-solvents, stabilizers, surfactants, lubricants, excipients,
`preservatives, buffers, antioxidants, sweeteners, water trapping agents,
`bulking agents, and taste masking agents may be included in the
`formulation. Id. at 9.
`
`2. Analysis
`Petitioner asserts that Rogueda discloses “HFA formulations with the
`exact same components and concentrations as the claimed formulation.”
`Pet. 37. Specifically, Petitioner asserts that Rogueda discloses a
`pharmaceutical composition comprising HFA 227 because “Rogueda
`teaches this propellant in multiple formulations throughout the reference,”
`when it refers to P227 and HFA 227. Id. As for the combination of
`budesonide and formoterol fumarate dihydrate, Petitioner asserts that
`Rogueda anticipates that limitation “under two different theories: (1)
`through Rogueda’s examples, and (2) through its control samples.” Id.
`Petitioner acknowledges that none of Rogueda’s examples or control
`samples include formulations comprising both active ingredients recited in
`the challenged claims. Id. However, Petitioner asserts that because
`Rogueda teaches that SymbicortTM (budesonide and formoterol) is among
`the suitable drugs that may be used in the formulation, a person of skill in
`the art would have understood that “a budesonide and formoterol
`formulation could be achieved by adding the budesonide or formoterol [] to
`any of the example or control formulation[s], or by combining example or
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`control formulations with each other such that they have both [active
`ingredients].” Id. at 37–38. In other words, Petitioner’s assertion that
`Rogueda discloses a formulation comprising a combination of budesonide
`and formoterol requires modifying the examples or controls to add
`budesonide or formoterol.
`Similarly, with respect to the recited concentrations for each active
`ingredient, Petitioner draws from a combination of examples or controls
`from Rogueda’s disclosures for such concentrations. For example,
`Petitioner asserts that Examples 8 and 11 provide weight percentages for
`formoterol fumarate dihydrate, and that other examples in Rogueda (not
`identified by Petitioner) provide weight percentages for budesonide. Id. at
`38–39. Petitioner provides no rationale for relying on the disclosure of
`values for each active ingredient that are set forth in different examples, nor
`do we find one. Such picking and choosing of values between Rogueda’s
`examples is insufficient to establish that those elements are “arranged as in
`the claim,” and are not presented “as mere catalogs of separate parts, in
`disregard of the part-to-part relationships set forth in the claims and that give
`the claims their meaning.” See Lindemann Maschinenfabrik GMBH, 730
`F.2d 1452, 1458-59.
`Moreover, Petitioner relies on Dr. Beasley’s conversion of the weight
`percentage values disclosed by Rogueda for each active ingredient to
`concentrations in order to then compare those to the concentrations recited
`for the active ingredients in the claims. Pet. 39. Dr. Beasley’s conversion
`assumes that a person of skill in the art would understand that Rogueda’s
`“12 ml canister would have a fill weight of at least 6 grams, and would
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`expect a fill weight of between 6 and 7 grams.” Ex. 1012 ¶ 96. However, as
`was the case with his calculations for Mistry, Dr. Beasley has not supported
`that statement with any evidence.
`Even if Dr. Beasley calculation was supported by evidence, the
`conversion yields a range of concentrations for the formoterol fumarate
`dihydrate in some of Rogueda’s sample formulations, i.e., between 0.08
`mg/ml to 0.147 mg/ml. Id. According to Petitioner, that converted range
`anticipates the claim recitation of 0.09 mg/ml of formoterol fumarate
`dihydrate. We are not persuaded by that argument as Petitioner again relies
`on (an alleged) prior art disclosure of a concentration range as a teaching to
`use a specific value recited in the challenged claim without an explanation
`for doing so. See Atofina, 441 F.3d at 999.
`Petitioner’s reliance on Dr. Beasley’s conversion of the weight
`percentages of formoterol disclosed in various control samples is equally
`problematic, as Dr. Beasley again relies upon an unsupported assertion with
`respect to the total fill weight of the canister used. Pet. 40–41; Ex. 1012 ¶¶
`99–100.
`Petitioner again resorts to picking and choosing from Rogueda’s
`disclosure in asserting that Rogueda teaches a formulation comprising PVP
`K25 and PEG 1000 by separately disclosing those elements in different lists
`of suitable and preferred excipients, wherein the number of preferred
`excipients listed is extensive. Pet. 42–43. As for the required concentration
`of PEG 1000, Petitioner asserts that Rogueda is anticipatory because it
`teaches “a concentration of 0.3% w/w twice” and a preferable excipient
`concentration from 0.01 to 1%. Id. at 43. Rogueda’s use of PEG-1000 at
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`0.3% w/w occurred in a control formulation and a reference formulation,
`neither of which included a combination of budesonide and formoterol
`fumarate dihydrate. Ex. 1004, 27 and 32. Petitioner has not explained how
`Rogueda’s disclosure of PEG-1000 at 0.3% w/w in those instances
`anticipates the claimed formulation comprising that element, along with a
`combination of budesonide and formoterol.
`Thus, upon review of Petitioner’s analysis and declaratory evidence,
`we determine that Petitioner has not established that Rogueda discloses each
`and every element as set forth and arranged in the claim, either expressly or
`inherently. See Verdegaal Bros., 814 F.2d 628, 631. Rather, Petitioner’s
`anticipation argument with respect to all of the challenged claims requires
`picking and choosing elements among a catalog of separate parts disclosed
`by Rogueda, relying upon a broad disclosure of value ranges to anticipate
`specific values recited by the challenged claims, and relying on an
`unsupported calculation by Dr. Beasley. Accordingly, we determine that
`Petitioner has not established a reasonable likelihood of prevailing in
`showing that Rogueda anticipates claims 1 and 4–15. Consequently, we
`decline to institute an inter partes review of any of those claims based on
`this ground.
`D. Obviousness over Mistry, Rogueda, and Carling
`Petitioner asserts that claims 1 and 4–15 are rendered obvious by the
`combined teachings of Mistry, Rogueda, and Carling. Pet. 46–52. Patent
`Owner disagrees. Prelim. Resp. 27–28.
`A conclusion that the claimed subject matter is obvious must be
`supported by evidence, as shown by some objective teaching in the prior art
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`IPR2017-00631
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`or by knowledge generally available to one of ordinary skill in the art that
`would have led that individual to combine the relevant teachings of the
`references to arrive at the claimed invention. See In re Fine, 837 F.2d 1071,
`1074 (Fed. Cir. 1988). Obviousness grounds must be supported with
`“articulated reasoning with some underpinning” and not by “mere
`conclusory statements.” See KSR Int’l Co. v. Teleflex Inc., 550 U.S 398, 418
`(2007).
`
`Carling
`1.
`Carling is directed to the use of a bronchodilator, i.e., formoterol
`(and/or a physiologically acceptable salt and/or solvate thereof) in
`combination with a steroidal anti-inflammatory drug, i.e., budesonide, to
`treat respiratory disorders and pharmaceutical compositions comprising a
`combination of those active ingredients. Ex. 1005, 1:10–17, 2:51–55.
`Carling teaches that the composition may be suspended or dissolved in a
`liquid propellant mixture, wherein the propellants are chlorofluorcarbons
`(“CFC’s”). Id. at 4:1–4.
`
`Analysis
`2.
`Petitioner contends that claims 1 and 4–15 are obvious over the
`combination of Mistry, Rogueda, and Carling. Petitioner asserts that a
`person of skill in the art would have been motivated to combine the
`teachings of those references because (a) Carling teaches an effective
`budesonide and formoterol composition comprising CFC’s, (b) changing
`legal requirements regarding CFC’s would have prompted an artisan to seek
`a non-CFC pressurized aerosol formulation, (c) Mistry provides an inhaler
`medicament formulation that may comprise Carling’s active ingredients and
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`IPR2017-00631
`Patent 7,759,328 B2
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`uses HFA as the propellant instead of CFC’s, (d) “[t]hrough selecting PVP
`and PEG, Mistry achieved stability and appropriate lubrication,” and (e)
`Rogueda teaches improved stability and “precise characterizations in its
`experimental and control samples of the concentrations of budesonide,
`formoterol, PVP, and PEG,” along with “a specific K-value to use for the
`PVP, and a specific average molecular weight for the PEG.” Pet. 46–48.
`We agree with Petitioner that a person of skill in the art may have
`been motivated to combine the teachings of Carling, Mistry and Rogueda.
`However, Petitioner has not shown persuasively that Rogueda teaches the
`elements of the challenged claims for which it is relied upon in the
`combination. Specifically, we are not persuaded that Rogueda would have
`taught a person of ordinary skill in the art to include the “concentrations of
`budesonide, formoterol, PVP, and PEG,” along with the “ specific K-value
`to use for the PVP, and a specific average molecular weight for the PEG” in
`one formulation as required by the claims, because Petitioner has not pointed
`to any disclosure in Rogueda or knowledge in the art that would have taught
`or suggested such a combination of those elements in one formulation.
`Moreover, we remain unpersuaded by Petitioner’s assertion that
`“Rogueda would teach the appropriate concentration by weight of
`formoterol fumarate dihydrate.” Id. at 48. Petitioner supports that assertion
`by referring back to its argument relating to this element in the anticipation
`ground involving Rogueda. Id. In particular, Petitioner again relies on
`Dr. Beasley’s conversion calculation that is based upon an unsupported
`assertion that a person of skill in the art “would know that the fill weights
`[for a 12 ml canister] could be between 6 grams and 10 grams (although a
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`POSITA would expect between 6 grams and 7 grams).” Id. at 48–49 (citing
`Ex. 1012 ¶ 124). Because Dr. Beasley does not adequately support
`assumptions made in his conversion calculation, we do not afford his
`testimony on that matter persuasive weight. See 37 C.F.R. § 42.65(a).
`Petitioner adds that “the formoterol mass and mass of the other
`components would stay the same or similar from Rogueda, and the POSITA
`would simply optimize for stability by altering the fill weights of HFA over
`this range of final mass.” Id. at 49 (citing Ex. 1012 ¶ 124). According to
`Dr. Beasley, “the POSITA would be expected to optimize for stability, but
`would start around the weight percentages for budesonide and formoterol
`from Rogueda.” Ex. 1012 ¶ 124. Dr. Beasley explains that su
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