`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`CATALENT PHARMA SOLUTIONS, INC.
`Petitioner
`
`v.
`
`PATHEON SOFTGELS INC.
`Patent Owner
`
`_____________________
`
`Case IPR2018-00421
`Patent 9,693,978
`_____________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`UNDER 37 C.F.R. § 42.107(a)
`
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`

`

`IPR2018-00421
`Patent No. 9,693,978
`
`TABLE OF CONTENTS
`
`I.
`II.
`
`B.
`
`Introduction ...................................................................................................... 1
`The Board should deny the petition because its grounds for unpatentability
`rely on a faulty and unreasonably broad claim construction. .......................... 7
`The petition relies on an unreasonably broad and faulty construction
`A.
`of “about 5%.” ....................................................................................... 7
`The Petition relies on a flawed construction of “fill material.” .......... 13
`B.
`III. Catalent has not articulated its reasons behind the multiple grounds asserted
`in the petition. ................................................................................................ 13
`IV. Ground 1: Catalent has not met its burden of establishing a reasonable
`likelihood that any of the challenged claims is anticipated by Chen or
`obvious in view of Chen. ............................................................................... 15
`The Petition fails to show that Chen anticipates any of the challenged
`A.
`claims. .................................................................................................. 15
`1. Chen does not disclose all of the elements of the challenged
`claims, expressly or inherently. ................................................ 15
`2. Chen does not disclose all the elements of the challenged claims,
`arranged as claimed. .................................................................. 22
`3. Chen fails to disclose all the elements of the challenged claims,
`as evidenced by the Petition’s resort to additional references to
`purportedly meet the claim limitations. .................................... 26
`4. Catalent’s anticipation arguments for dependent claims also fail.
` ................................................................................................... 28
`The Petition fails to show that Chen renders obvious any of the
`challenged claims ................................................................................ 30
`The Petition fails to explain why or how the artisan would have
`1.
`purportedly modified Chen to arrive at the compositions and
`methods as claimed. .................................................................. 31
`The Petition fails to explain why the artisan would have had a
`reasonable expectation of success. ............................................ 33
`The Petition fails to demonstrate that the claimed invention
`could have been generated through routine optimization. ........ 35
`The Petition fails to address previously asserted objective indicia
`of nonobviousness. .................................................................... 36
`
`2.
`
`3.
`
`4.
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`IPR2018-00421
`Patent No. 9,693,978
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`V. Ground 2: Catalent has not met its burden of establishing a reasonable
`likelihood that any of the challenged claims would have been obvious in
`view of Kim or in view of Kim and Chen. .................................................... 42
`The Petition fails to show that Kim renders obvious any of the
`A.
`challenged claims. ............................................................................... 42
`1. Kim does not disclose or suggest all the elements of the
`challenged claims. ..................................................................... 43
`The Petition fails to explain why or how a skilled artisan would
`have modified Kim to arrive at the compositions as claimed. .. 44
`The Petition fails to show why a skilled artisan would have had
`a reasonable expectation of success. ......................................... 49
`The Petition fails to demonstrate that the claimed invention
`could have been generated through routine optimization. ........ 50
`5. Catalent’s obviousness arguments for dependent claims also fail.
` ................................................................................................... 50
`The Petition fails to show that Kim in view of Chen renders obvious
`any of the challenged claims. .............................................................. 51
`The Petition fails to address previously asserted objective indicia of
`nonobviousness. .................................................................................. 51
`VI. Ground 3: Catalent has not met its burden of establishing a reasonable
`likelihood that any of the challenged claims are anticipated by Schoenhard
`or obvious in view of Schoenhard. ................................................................ 52
`The Petition fails to show that Schoenhard anticipates any of the
`A.
`challenged claims. ............................................................................... 52
`Schoenhard does not disclose all the elements of the challenged
`1.
`claims. ....................................................................................... 53
`Schoenhard fails to disclose all the elements of the challenged
`claims, as evidenced by the Petition’s resort to additional
`references. ................................................................................. 58
`3. Catalent’s anticipation arguments for dependent claims also fail.
` ................................................................................................... 59
`The Petition fails to show that Schoenhard renders obvious any of the
`challenged claims. ............................................................................... 60
`
`B.
`
`C.
`
`B.
`
`2.
`
`3.
`
`4.
`
`2.
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`1.
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`IPR2018-00421
`Patent No. 9,693,978
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`The Petition fails to explain why or how the artisan would have
`purportedly modified Schoenhard to arrive at the compositions
`and methods as claimed. ........................................................... 60
`The Petition fails to explain why the artisan would have had a
`reasonable expectation of success. ............................................ 62
`The Petition fails to demonstrate that the claimed invention
`would have been generated through routine optimization. ....... 62
`The petition fails to address known objective indicia of
`nonobviousness. ........................................................................ 63
`VII. Mr. Draper’s declaration provides biased and unsubstantiated testimony—
`the Board should accord it no weight. ........................................................... 64
`VIII. Conclusion ..................................................................................................... 67
`
`2.
`
`3.
`
`4.
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` IPR2018-00421
`Patent No. 9,693,978
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`Patent Owner Patheon Softgels Inc. (“Patheon”) provides this Preliminary
`
`Response to the Petition for inter partes review (“IPR”) of claims 1-38 of U.S.
`
`Patent No. 9,693,978 (“the ’978 Patent”; EX1003) filed by Petitioner Catalent
`
`Pharma Solutions, Inc. (“Catalent”).
`
`I.
`
`Introduction
`
`Catalent is attempting to knock out Patheon’s claims protecting novel and
`
`commercially successful naproxen formulations. But to even be instituted, a
`
`petition for inter partes review must meet its burden to establish a reasonable
`
`likelihood that it could prevail against at least one challenged claim—a
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`requirement that Catalent’s petition fails to meet because it neither complies with
`
`the Board’s filing requirements under 37 C.F.R. § 42.104 nor addresses key
`
`elements of anticipation and obviousness necessary to prevail on the merits.
`
`Catalent’s Petition fails to comply with the Board’s filing requirements on
`
`several levels. First, the Petition does not identify the challenged claims with
`
`particularity, but instead presents a vague and conclusory series of attorney
`
`arguments. See 37 C.F.R. § 42.104(b). Second, the grounds in the Petition each
`
`include an alternative argument, essentially doubling the number of asserted
`
`grounds, and the Petition fails to explain Catalent’s reasoning behind the multiple
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`IPR2018-00421
`Patent No. 9,693,978
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`grounds or alternative grounds. See generally 37 C.F.R. § 1.104. Third, the Petition
`
`improperly incorporates by reference extensive arguments from the Draper
`
`declaration that are not presented in the Petition. See 37 C.F.R. § 42.6(a)(3).
`
`Catalent’s Petition fails on the merits as well because its art-based
`
`challenges are premised on faulty claim construction and it misapplies the laws of
`
`anticipation and obviousness. Catalent first provides an unreasonably broad and
`
`faulty construction of the term “about 5%” with complete disregard for the plain
`
`language of the claims and the intrinsic evidence in the ’978 patent specification
`
`and its file history.
`
`The Petition then proceeds to misapply controlling law of anticipation and
`
`obviousness. Notably, Catalent’s anticipation arguments rely on alleged inherent
`
`disclosures in its lead references, U.S. Patent no. 6,383,471 (“Chen,” EX1009) and
`
`U.S. Patent Application Publication no. US 2004/0224020 A1 (“Schoenhard,”
`
`EX1011). Yet, the law is clear: inherent anticipation requires that the missing
`
`descriptive material is necessarily present, not merely probably or possibly
`
`present, in the prior art. Catalent’s inherent anticipation arguments impermissibly
`
`rely on the arbitrary selection from a myriad of variables: dosage amount, capsule
`
`size, and fill material density. For each, Catalent contrives a specific value, then
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`IPR2018-00421
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`performs calculations presumably preordained to establish anticipatory disclosure
`
`of the claim limitations of the ’978 patent. But none of Chen, Kim, or Schoenhard
`
`discloses any naproxen sodium dosage amounts, any softgel capsule sizes, or any
`
`particular density of fill material. For example, the Board is not told why
`
`Catalent’s declarant chose an oblong capsule said to hold 880 milliliters of liquid.
`
`Nor is the Board told why the fill material density is arbitrarily set to the density of
`
`water. The cited references do not expressly or inherently guide any of the above
`
`parameters, nor are any of the selections a “necessary consequence of what was
`
`deliberately intended” of the disclosures such that the “about 5%” claim limitation
`
`is necessarily met. MEHL/Biophile Intern. Corp. v. Milgraum, 192 F. 3d 1362,
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`1366 (Fed. Cir. 1999). This is not inherent anticipation.
`
`Moreover, Catalent’s anticipation arguments pick and choose elements from
`
`long and disparate lists of compounds in Chen and Schoenhard. An anticipatory
`
`reference, however, must disclose each and every element arranged as claimed,
`
`without any need for picking, choosing, and combining disparate disclosures in the
`
`reference. In re Arkley, 455 F.2d 586, 587 (C.C.P.A. 1972). Catalent’s anticipation
`
`arguments therefore fail on multiple levels.
`
`Catalent’s obviousness arguments suffer similar deficiencies. The Petition
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`IPR2018-00421
`Patent No. 9,693,978
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`saddles the Board and Patheon with guessing Catalent’s arguments as to why and
`
`how a person of ordinary skill in the art allegedly would have combined or
`
`modified the cited art with a reasonable expectation of success. These deficiencies
`
`relate to the core fundamentals of an obviousness analysis and prove fatal to the
`
`Petition’s obviousness arguments. Further, Catalent’s Petition fails to demonstrate
`
`unpatentability in the face of publicly-available objective indicia evidence, such as
`
`evidence of unexpected results. In fact, the Petition fails to adequately address
`
`objective indicia altogether. “The Petition … should have addressed the evidence
`
`of unexpected results as part of Petitioner’s showing of a reasonable likelihood of
`
`success on the merits.” Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche
`
`Inc., IPR2015-01792, Paper 14, at 18 (March 11, 2016).
`
`Given the numerous deficiencies in Catalent’s cited art and arguments, it is
`
`no wonder that the art failed to teach a softgel composition comprising a naproxen
`
`salt as claimed in the ’978 patent. Patheon submits expert testimony from Mansoor
`
`Khan, Ph.D., a renowned pharmaceutical formulations expert with over 25 years of
`
`experience in the field, explaining that Catalent’s declarant’s analysis of the art is
`
`riddled with errors, mischaracterizations of the art, and gaps in scientific logic.
`
`Catalent’s declarant, Mr. Draper—who is employed by a Catalent subsidiary
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`company—makes several improper assertions. For example, Mr. Draper
`
`improperly equates disclosures of “naproxen” in the art with disclosures of
`
`“naproxen sodium.” EX1001, ¶41. As Dr. Khan explains, a skilled artisan would
`
`have considered these compounds to be two different drugs, not simply different
`
`formulations of the same drug. PSG2001, ¶¶29-31, 51. Mr. Draper also improperly
`
`asserts that citric acid and lactic acid are “functional equivalents or substitutable in
`
`naproxen softgel formulations.” EX1001, ¶39. But Dr. Khan shows that the art
`
`contradicts Mr. Draper’s assertions: citric acid and lactic acid were known to be
`
`different compounds with different properties when used in pharmaceutical
`
`formulations. PSG2001, ¶¶43-50, 67.
`
`Mr. Draper’s analysis also fails to account for the state of the art in softgel
`
`capsule formulations before the ’978 patent. Before March 8, 20051, artisans
`
`generally understood that soft gelatin capsule formulations could offer certain
`
`
`1 The cover page of the ’978 patent lists March 3, 2005, as the filing date for
`
`provisional application no. 60/659,679. EX1003, at 1. The March 3, 2005 date is a
`
`typographical error. The correct filing date for application no. 60/659,679 is March
`
`8, 2005. EX1004, at 1.
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`IPR2018-00421
`Patent No. 9,693,978
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`advantages over conventional tablet dosage forms. PSG2001, ¶¶32-34; PSG2010,
`
`at 62; PSG2023, at 395–396. Despite these known advantages, the art failed to
`
`provide softgel capsule formulations of a naproxen salt, as provided in the ’978
`
`patent.
`
`Artisans knew that, for a drug to be efficiently absorbed and diffuse across
`
`the intestinal lumen, the drug needed to be in solution or solubilized form at the
`
`site of absorption. PSG2001, ¶33; PSG2008, at 612; PSG2009, at 1. Artisans
`
`understood that the simplest way to present a drug to the gastrointestinal tract for
`
`absorption is to administer the drug in solution or solubilized form, because this
`
`way, the active pharmaceutical ingredient is already in solution at the absorption
`
`site without requiring any dissolution rate-limiting steps that were associated with
`
`solid tablet formulations. PSG2001, ¶34.
`
`Despite the known general advantages of liquid softgel capsule formulations
`
`over solid tablets, artisans learned that dissolving naproxen sodium in non-aqueous
`
`solvents like polyethylene glycol (“PEG”) resulted in the formation of naproxen-
`
`PEG esters, which were considered unacceptable impurities that reduced
`
`bioavailability. PSG2001, ¶¶35-36; PSG2005, at 4:1–6; 7:9–12; 11:21–24;
`
`PSG2006, at 147; EX1010, ¶[0061]. Thus, before March 8, 2005, there was a need
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`IPR2018-00421
`Patent No. 9,693,978
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`for a liquid softgel formulation that offered good active pharmaceutical ingredient
`
`solubility, stability, and bioavailability, such as a naproxen salt liquid softgel
`
`formulation. PSG2001, ¶37. The inventors of the ’978 patent solved this problem
`
`for naproxen by developing novel, liquid softgel formulations.
`
`Indeed, before the ’978 patent’s invention, naproxen sodium was formulated
`
`as a solid tablet for nearly 30 years until 2006 when the FDA approved Banner
`
`Pharmacaps’ naproxen sodium softgel formulation (which is encompassed by the
`
`’978 patent) under NDA application no. 21-920. PSG2001, ¶31; PSG2016-
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`PSG2020.
`
`In sum, the Board should deny institution because the information presented
`
`in the Petition and in this Preliminary Response demonstrates that there is not a
`
`reasonable likelihood that the Petitioner would prevail on even one of its
`
`challenges to claims 1–38.
`
`II. The Board should deny the petition because its grounds for
`unpatentability rely on a faulty and unreasonably broad claim
`construction.
`A. The petition relies on an unreasonably broad and faulty
`construction of “about 5%.”
`
`Catalent argues that the broadest reasonable interpretation of the phrase
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`IPR2018-00421
`Patent No. 9,693,978
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`“about 5% lactic acid by weight of the fill material” in the challenged claims
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`“includes at least from 2 to 8% lactic acid by weight of the fill material.” Pet., at
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`12-13 (emphasis added). Catalent’s construction of “about 5%” is unreasonably
`
`broad, ignores intrinsic evidence in the ’978 patent’s specification and prosecution
`
`history, and ultimately provides a faulty premise for each of the unpatentability
`
`grounds asserted in the Petition.
`
`Claim terms of the ’978 patent are interpreted according to their broadest
`
`reasonable interpretation (“BRI”). 37 C.F.R. § 42.100(b). Under the BRI2, “claims
`
`should always be read in light of the specification and teachings in the underlying
`
`
`2 On May 9, 2018, the U.S. Department of Commerce proposed changing
`
`the claim construction standard in IPRs from the BRI to construing the claim in
`
`accordance with the ordinary and customary meaning of the claim as understood
`
`by one of ordinary skill in the art and the prosecution history pertaining to the
`
`patent—i.e., the standard set forth in Phillips v. AWH Corp., 415 F.3d 1303 (Fed.
`
`Cir. 2005) (en banc). See 83 FED. REG. 21221 (proposed May 9, 2018). Catalent’s
`
`construction of “about5%” is faulty and unreasonably broad under the Phillips
`
`standard for the same reasons discussed herein under the BRI standard.
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`IPR2018-00421
`Patent No. 9,693,978
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`patent.” In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010).
`
`Moreover, “the prosecution history, while not literally within the patent document,
`
`serves as intrinsic evidence for purposes of claim construction. This remains true
`
`in construing patent claims before the PTO.” Tempo Lighting Inc. v. Tivoli LLC,
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`742 F.3d 973, 977 (Fed. Cir. 2014) (emphasis added). While the Board “must give
`
`the terms their broadest reasonable construction, the construction cannot be
`
`divorced from the specification and the record evidence.” In re NTP, Inc., 654 F.3d
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`1279, 1288 (Fed. Cir. 2011) (emphasis added) (citing Suitco, 603 F.3d at 1259).
`
`Here, Catalent’s construction of “about 5%” is entirely divorced from the
`
`plain language of the claims. Under Catalent’s construction, “about 5%” can mean
`
`“at least” up to 60% higher (i.e., 8%) or “at least” 60% lower (i.e., 2%) than 5%.
`
`As Dr. Khan explains, a skilled artisan would not have considered “about 5%” to
`
`include a range extending “at least” up to 60% higher or 60% lower than the
`
`middle point of 5%. PSG2001, ¶¶20-28. This does not reflect the plain and
`
`ordinary meaning of “about.” Id. To the contrary, a skilled artisan would have
`
`considered the plain and ordinary meaning of the term “about 5%” to be:
`
`“approximately 5%.” Id.; see, e.g., Merck & Co. v. Teva Pharmaceuticals USA,
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`395 F.3d 1364, 1372 (Fed. Cir. 2005) (“the term ‘about’ should be given its
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`IPR2018-00421
`Patent No. 9,693,978
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`ordinary and accepted meaning of ‘approximately’”).
`
`Catalent’s construction is flawed for several reasons. First, Catalent bases its
`
`construction on a single formulation disclosed in Example 8 of the ’978 patent.
`
`Pet., at 12. Catalent makes the legally unfounded argument that the BRI of about
`
`5% “must include” a range of lactic acid amounts that encompasses the
`
`formulation of Example 8. Id. (emphasis added). But Catalent provides no
`
`authority for such a principle. To the contrary, it is well-established law that the
`
`claims need not encompass every alternative embodiment in the patent. “[T]o
`
`construe the claim term to encompass the alternative embodiment in this case
`
`would contradict the language of the claims. Indeed, read in the context of the
`
`specification, the claims of the patent need not encompass all disclosed
`
`embodiments.” TIP Sys., LLC v. Phillips & Brooks/Gladwin, Inc., 529 F.3d 1364,
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`1373 (Fed. Cir. 2008) (emphasis added).
`
`Second, Catalent assumes in its purported calculations that a skilled artisan
`
`would have interpreted the disclosed amount of lactic acid in Example 8 (“0.24-
`
`0.35M”) to mean “0.24–0.35 mole equivalents of lactic acid per mole equivalent of
`
`naproxen sodium,” Pet., at 12. Using this interpretation, the amount of lactic acid
`
`present in the formulation of Example 8 would be between 2.1–3.1% lactic acid by
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`IPR2018-00421
`Patent No. 9,693,978
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`weight of the fill material, which is not “about 5%.” PSG2001, ¶¶23-24.
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`As Dr. Khan explains, a skilled artisan would recognize that the Examples in
`
`the ’978 patent related to “about 5% lactic acid” are Examples 7 (5.27% lactic
`
`acid) and Examples 9–12 (5.00% lactic acid). PSG2001, ¶¶22-24. The skilled
`
`artisan would have understood that the examples in the specification provide
`
`specific percentages of lactic acid by weight of the fill material, calculated to the
`
`hundredths of a percent. PSG2001, ¶24; EX1003, Example 7 (disclosing a
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`composition comprising 5.27% lactic acid by weight of the fill material); Examples
`
`9–12 (disclosing compositions comprising 5.00% lactic acid by weight of the fill
`
`material). Thus, Dr. Khan explains that the artisan would not have considered a
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`formulation comprising 2.1–3.1% lactic acid to be “about 5%” lactic acid by
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`weight of the fill material as claimed. PSG2001, ¶24. It is of no moment that the
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`formulation of Example 8 discloses an alternative embodiment that is not be
`
`encompassed by the claims, because the law does not require construction of claim
`
`terms to encompass all disclosed embodiments. See TIP Systems, 529 F.3d at 1373.
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`Third, Catalent’s construction of “about 5%” to mean “at least from 2 to
`
`8%” is unreasonable because it is nearly the same scope as original claim 1,
`
`ignoring the fact that the claims were amended during prosecution. EX1006, at
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`Patent No. 9,693,978
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`128, 206, 208. During prosecution of the ’978 patent, the Applicant pursued
`
`independent claim 1 directed to a pharmaceutical composition comprising “a
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`naproxen salt” and “lactic acid in an amount from about 0.2 to about 1.0 mole
`
`equivalents per mole of naproxen salt.” See EX1006, at 128. And dependent claim
`
`3 at the time, which depended from claim 1 and thus was narrower than claim 1,
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`was directed to the composition of claim 1 “wherein the lactic acid comprises
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`about 5% by weight.” Thus, “about 5%” lactic acid by weight is narrower than
`
`“0.2 to about 1.0 mole equivalents per mole of naproxen salt.” “[W]here … the
`
`claims describe the same relationship using different terms, the assumption is that
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`the term in the dependent claim has a narrower scope.” American Piledriving
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`Equipment, Inc. v. Geoquip, Inc., 637 F.3d 1324, 1335 (Fed. Cir. 2011).
`
`Examples 8–12 of the ’978 patent use a formulation comprising 25%
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`naproxen sodium by weight. If a POSA were to include lactic acid in such
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`formulations in an amount from “about 0.2 to about 1.0 mole equivalents per mole
`
`of naproxen salt,” converting the amount of lactic acid to a percentage by weight
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`results in about 1.8% to 8.9% lactic acid by weight of the fill material. PSG2001,
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`¶¶25-28. Catalent’s construction of “about 5%” to mean “at least from 2 to 8%” is
`
`unreasonable because it is nearly the same scope as original claim 1, ignoring the
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`IPR2018-00421
`Patent No. 9,693,978
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`fact that the claims were amended during prosecution. EX1006, at 128, 206, 208.
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`In view of the plain language of the claims and the intrinsic evidence in the
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`’978 patent’s specification and prosecution history, the Board should reject
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`Catalent’s construction of “about 5%” as being unreasonably broad. Instead, the
`
`term “about 5%” should be given its plain and ordinary meaning: “approximately
`
`5%.” PSG2001, ¶¶20-28.
`
`B. The Petition relies on a flawed construction of “fill material.”
`The Petition construes “fill material” to mean “the material for filling the
`
`soft gelatin capsule prepared by mixing the claimed ingredients in the claimed
`
`amounts prior to encapsulation.” Pet., at 13. Patheon does not concede that
`
`Catalent’s construction of “fill material” is correct. Nonetheless, Patheon submits
`
`that construction of this term is unnecessary for the Board to resolve the issues in
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`this proceeding.
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`III. Catalent has not articulated its reasons behind the multiple grounds
`asserted in the petition.
`
`As discussed below in Sections IV–VI, the Board should deny institution on
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`all grounds because Catalent’s Petition fails to show a reasonable likelihood of
`
`prevailing on the merits in any of Grounds 1–3, which are six grounds disguised as
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`three. Notwithstanding the Supreme Court’s recent decision in SAS Institute Inc. v.
`
`Iancu, 138 S.Ct. 1348 (2018), Catalent still carries the burden to articulate its
`
`reasoning behind each ground of unpatentability—a burden the Petition fails to
`
`meet. See 37 C.F.R. § 42.104.
`
`Here, Catalent’s Petition asserts six grounds for unpatentability without
`
`providing any meaningful distinction between the grounds: (i) anticipation by
`
`Chen; (ii) obviousness over Chen; (iii) obviousness over Kim; (iv) obviousness
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`over Kim and Chen; (v) anticipation by Schoenhard; and (vi) obviousness over
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`Schoenhard. Pet., at 4. Catalent fails to identify the relative strengths and
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`weaknesses of its arguments. For example, Catalent alleges in Ground 1 that Chen
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`discloses all the element of the claims, and then attempts to argue in Ground 2 that
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`the challenged claims would have been obvious over the combination of Kim and
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`Chen without explaining why Kim is more preferred for allegedly satisfying some
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`elements, while Chen is more preferred for allegedly satisfying other elements.
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`Catalent fails to meet its burden of articulating the reasons behind its different
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`grounds in the Petition. See Oracle Corp. v. Clouding IP, LLC, IPR2013-00088,
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`Paper 13, at 3 (June 13, 2013).
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`As to the merits, which are discussed below, this Preliminary Response
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`IPR2018-00421
`Patent No. 9,693,978
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`shows that the Petition fails on numerous levels to establish a reasonable likelihood
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`of prevailing on the merits in any of the arguments in Grounds 1–3. Each ground is
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`discussed in turn.
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`IV. Ground 1: Catalent has not met its burden of establishing a reasonable
`likelihood that any of the challenged claims is anticipated by Chen or
`obvious in view of Chen.
`A. The Petition fails to show that Chen anticipates any of the
`challenged claims.
`Under 35 U.S.C. § 314(a), the petitioner must establish in the petition “a
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`reasonable likelihood that the petitioner would prevail with respect to at least 1 of
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`the claims challenged in the petition.” Id.; see also, 37 C.F.R. § 42.108(c).
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`Catalent’s Petition fails to make this threshold showing for at least two reasons: (i)
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`Chen does not disclose all of the elements of the challenged claims and the Petition
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`fails to show that Chen inherently discloses the missing elements; and (ii) even if
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`Chen did disclose elements of the claims, the disclosures are not arranged as
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`claimed in the ’978 patent.
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`1. Chen does not disclose all of the elements of the challenged
`claims, expressly or inherently.
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`Catalent first fails to show that Chen expressly or inherently discloses all the
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`elements of the challenged claims of the ’978 patent. Claim 1 of the ’978 patent
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`IPR2018-00421
`Patent No. 9,693,978
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`recites:
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`A pharmaceutical composition comprising soft gelatin
`capsule comprising a fill material comprising:
`(a) a naproxen salt;
`(b) about 5% lactic acid by weight of the fill material;
`and
`(c) polyethylene glycol.
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`EX1003, Claim 1. Independent claims 10, 18, 20, and 21 also recite “about 5%”
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`lactic acid by weight of the fill material. EX1003, Claims 10, 18, 20, 21.
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`Chen fails to expressly or inherently disclose compositions or methods
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`comprising “about 5%” lactic acid by weight of the fill material, as recited in
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`independent claims 1, 10, 18, 20, and 21. The Petition relies on Chen’s disclosure
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`of compositions comprising an ionizing agent present in an amount of “at least
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`about 0.5 mole equivalents” “per mole of ionizable functional group.” EX1009,
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`12:30-35; Pet., at 19. In other words, the Petition relies on Chen’s disclosure of a
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`ratio: for every 1.0 mole of ionizable functional group present in the active
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`pharmaceutical ingredient, Chen teaches to include 0.5 moles of an ionizing agent.
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`EX1009, 12:30-35. But without knowing how much of the active pharmaceutical
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`ingredient is present in Chen’s formulation, one cannot determine the actual
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`IPR2018-00421
`Patent No. 9,693,978
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`amount of ionizing agent present in Chen’s formulation. PSG2001, ¶¶54-55. This
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`is neither an express nor inherent disclosure of “about 5% lactic acid by weight of
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`the fill material” because Chen does not disclose any dosage amounts for a
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`naproxen salt. Id. Unable to show where in Chen each element of the challenged
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`claims is purportedly disclosed, Catalent concocts a flawed inherent anticipation
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`argument based on a series of arbitrary assumptions to arrive at “about 5% lactic
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`acid.”
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`To begin, the art taught a wide range of naproxen dosages not limited to 220
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`mg or 250 mg as Catalent would have the Board believe. For example, Shapiro
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`disclosed a naproxen dosage range from 125 mg to 1.25 g daily, from 0.5 mg/kg to
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`25 mg/kg daily, or from 50 mg to 1.5 g daily; and naproxen sodium dosage range
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`from 50 mg to 1.65 g daily. PSG2007, at 61, lines 13–14; 70, lines 2–3; 71, lines
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`29–30; 96, lines 23–26; PSG2001, ¶¶40-42, 55. And even the FDA-approved
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`naproxen and naproxen sodium solid tablet formulations at the time included a
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`wide range of dosage amounts, ranging from 220 mg to 825 mg doses. PSG2001,
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`¶¶40-42, 55. From among these vast possibilities, Catalent contrived specific doses
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`of 220 mg and 250 mg to support its inherent anticipation arguments. Pet., at 19,
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`24, 25, 31; EX1001, ¶89, p. 42-43. Moreover, even if 220 mg and 250 mg were
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`IPR2018-00421
`Patent No. 9,693,978
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`among the dosage possibilities from which a skilled artisan could have chosen,
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`Chen does not disclose these dosages. Inherency “may not be established by
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`probabilities or possibilities. The mere fact that a certain thing may result from a
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`given set of circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745
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`(Fed. Cir. 1999) (quotation omitted); see also, In re Montgomery, 677 F.3d 1375,
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`1384 (Fed. Cir. 2012) (“inherency does not follow even from a very high
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`likelihood that a prior art method will result in the claimed invention.”)
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`The petition is also defective because Catalent and Mr. Draper arbitrarily
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`select an “880 ml capsule (i.e., a nominal size 14 Oblong capsule)” as the size
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`capsule an artisan purportedly would have used “to encapsulate 220 mg naproxen
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`sodium.” Pet., at 19; EX1001, ¶89. Catalent and Mr. Draper also arbitrarily select a
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`“conventional 800 ml capsule” size to encapsulate a “conventional dosage of 250
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`mg.” Pet., at 19; EX1001, ¶89. Again, this disclosure is nowhere in Chen. Chen
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`does not disclose an “880 ml” capsule, an “800 ml” capsule, or any other size
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`capsule.3 The art taught numerous varieties of soft gelatin capsule shapes and sizes,
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`3 The petition and Mr