Case No. IPR2015-01718
`Patent No. 8,945,621
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
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`COALITION FOR AFFORDABLE DRUGS VII LLC
`Petitioner
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`v.
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`POZEN INC.
`Patent Owner
`______________
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`Case No. IPR2015-01718
`Patent No. 8,945,621
`______________
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`PATENT OWNER’S REQUEST FOR REHEARING OF THE
`DECISION TO INSTITUTE TRIAL
`37 C.F.R. § 42.71(c)
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`Patent No. 8,945,621
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
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`COALITION FOR AFFORDABLE DRUGS VII LLC
`Petitioner
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`v.
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`POZEN INC.
`Patent Owner
`______________
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`Case No. IPR2015-01718
`Patent No. 8,945,621
`______________
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`PATENT OWNER’S REQUEST FOR REHEARING OF THE
`DECISION TO INSTITUTE TRIAL
`37 C.F.R. § 42.71(c)
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`TABLE OF CONTENTS
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`Case No. IPR2015-01718
`Patent No. 8,945,621
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` Page(s)
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`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED .......... 1
`I.
`LEGAL STANDARDS ................................................................................. 3
`II.
`III. BASIS FOR RELIEF REQUESTED ............................................................. 4
`A.
`The Petition and Preliminary Response Both Acknowledge that
`the Final “Wherein” Clause Should Be Given Patentable
`Weight .................................................................................................. 4
`The Examiner Added the Final “Wherein” Clause in an
`Examiners Amendment ........................................................................ 6
`The Final “Wherein” Clause Is Entitled to Patentable Weight
`Because it Was Added by the Examiner as a Condition for
`Allowance ............................................................................................. 8
`IV. THE PATENTABLE WEIGHT OF THE FINAL “WHEREIN”
`CLAUSE SHOULD BE DECIDED AT THIS STAGE OF THE
`PROCEEDING ............................................................................................. 11
`CONCLUSION ............................................................................................. 11
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`B.
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`C.
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`V.
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`Case No. IPR2015-01718
`Patent No. 8,945,621
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
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`Biosig Instruments, Inc. v. Nautilus, Inc.,
`715 F.3d 891 (Fed. Cir. 2013), vacated and remanded on other
`grounds, 134 S. Ct. 2120 (2014) ........................................................................... 9
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`Biosig Instruments, Inc. v. Nautilus, Inc.,
`783 F.3d 1374 (Fed. Cir. 2015) ............................................................................ 9
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`Eli Lilly & Co. v. Bd. of Regents of the Univ. of Wash.,
`334 F.3d 1264 (Fed. Cir. 2003) ............................................................................ 3
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`Eltech Sys. Corp. v. PPG Indus., Inc.,
`710 F. Supp. 622 (W.D. La. 1988), aff’d, 903 F.2d 805
`(Fed. Cir. 1990) ................................................................................................... 10
`
`Hoffer v. Microsoft Corp.,
`405 F.3d 1326 (Fed. Cir. 2005) (per curiam) ....................................................... 9
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`Minton v. Nat’l Ass’n of Secs. Dealers, Inc.,
`336 F.3d 1373 (Fed. Cir. 2003) .................................................................... 2, 8, 9
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`Research Found. of State Univ. of New York v. Mylan Pharm. Inc.,
`723 F. Supp. 2d 638 (D. Del. 2010) ...................................................................... 9
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`Stevens v. Tamai,
`366 F.3d 1325 (Fed. Cir. 2004) ............................................................................ 3
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`Texas Instruments, Inc. v. U.S. Int’l Trade Comm’n,
`988 F.2d 1165 (Fed. Cir. 1993) ........................................................................ 2, 8
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`Thermalloy Inc. v. Aavid Eng'g, Inc.,
`935 F. Supp. 55 (D.N.H. 1996), amended by, 935 F. Supp. 63
`(D.N.H. 1996), aff’d, 121 F.3d 691 (Fed. Cir. 1997) ..................................... 9, 10
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`ii
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`Case No. IPR2015-01718
`Patent No. 8,945,621
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`Other Authorities
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`37 C.F.R. § 42.1(b) .................................................................................................. 11
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`37 C.F.R. § 42.71 ................................................................................................... 1, 3
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`M.P.E.P. § 2111.04 .................................................................................................... 2
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`iii
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`Case No. IPR2015-01718
`Patent No. 8,945,621
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`Pursuant to 37 C.F.R. § 42.71(c), Horizon Pharmaceuticals, Inc. (“Horizon”)
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`and Pozen Inc. (“Pozen”) (collectively, “Patent Owner”)1 respectfully request a
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`rehearing in response to the Decision, Institution of Inter Partes Review of U.S.
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`Patent No. 8,945,621 (“Decision”) (Paper No. 17).
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`I.
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`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED
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`On February 22, 2016, the Board authorized the institution of this inter
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`partes review of claims 1-16 of U.S. Patent No. 8,945,621 (“the ’621 patent”) on
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`the two grounds presented in the petition: (1) obviousness of claims 1-16 over
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`Plachetka, Graham, and Goldstein; and (2) obviousness of claims 1-16 over
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`Plachetka alone. See Decision at 21. Patent Owner respectfully requests
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`reconsideration of the Board’s decision to institute on both grounds.
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`Agreeing with Patent Owner, the Board found that Coalition for Affordable
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`Drugs VII, LLC (“Petitioner”) failed to establish that Plachetka, Graham, or
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`Goldstein—alone or in combination—teaches or suggests the final “wherein”
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`clause of independent claims 1, 8, 15, and 16: “administration of the unit dose
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`form is more effective at reducing the incidence of the NSAID-associated ulcers in
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` 1
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` As explained in Patent Owner’s Mandatory Notices, Paper No. 7, Pozen is
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`the assignee of the ’621 patent and Horizon is its exclusive licensee.
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`1
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`Patent No. 8,945,621
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`patients taking LDA than in patients not taking LDA who are administered the unit
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`dose form.” Decision at 14.
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`Nevertheless, the Board concluded that “an underlying issue—not yet
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`addressed on this record—is whether the ‘final wherein clause’ of the independent
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`claims is entitled to patentable weight.” Id. at 15-16. This “wherein” clause is
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`significant, however, because it limits the claim scope of the independent claims
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`(as set forth in M.P.E.P. § 2111.04), and therefore is entitled to patentable weight.
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`In fact, the Examiner expressly added this “wherein” clause in the Notice of
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`Allowance to provide a single limitation in the claims commensurate in scope to
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`the unexpected results demonstrated by the ’621 patent.2 These factors distinguish
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`this case from those cited in the Decision—Texas Instruments and Minton—and
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`make clear that this “wherein” clause is entitled to patentable weight. Given that
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`deciding this issue—whether or not to give patentable weight to the final
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` 2
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` Patent Owner noted in response to the Examiner’s statement of reasons for
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`allowance that many different unexpected results in patients taking LDA have been
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`demonstrated by the ’621 patent, and that the Examiner has pointed to a single
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`unexpected result. (12/16/14 Applicant’s Response to Examiner’s Statement of
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`Reasons for Allowance, Ex. 1002 Pt. A at 10-11.)
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`2
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`“wherein” clause—is dispositive to Board’s institution of this inter partes review,
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`the Patent Owner respectfully requests that the Board reconsider its conclusion in
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`light of the ’621 patent’s prosecution history and deny the Petition.
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`This Request for Rehearing on behalf of the Patent Owner is filed within 14
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`days of the Decision (Paper No. 17) and is timely under 37 C.F.R. § 42.71.
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`II. LEGAL STANDARDS
`Pursuant to 37 C.F.R. § 42.71(d), a request for rehearing “must specifically
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`identify all matters the party believes the Board misapprehended or overlooked,
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`and the place where each matter was previously addressed in a motion, an
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`opposition, or reply.”
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`“When rehearing a decision on petition, a panel will review the decision for
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`an abuse of discretion.” 37 C.F.R. § 42.71(c). “An abuse of discretion occurs
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`where the decision (1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on
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`an erroneous conclusion of law; (3) rests on clearly erroneous fact findings; or (4)
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`involves a record that contains no evidence on which the Board could rationally
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`base its decision.” Stevens v. Tamai, 366 F.3d 1325, 1329 (Fed. Cir. 2004) (citing
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`Eli Lilly & Co. v. Bd. of Regents of the Univ. of Wash., 334 F.3d 1264, 1266-67
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`(Fed. Cir. 2003)).
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`Patent No. 8,945,621
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`III. BASIS FOR RELIEF REQUESTED
`The Patent Owner requests reconsideration of both grounds of the Decision
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`to institute on claims 1-16 as obvious over (1) Plachetka, Graham, and Goldstein;
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`and (2) Plachetka because the Decision misinterprets the final “wherein” clauses of
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`independent claims 1, 8, 15, and 16.
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`A. The Petition and Preliminary Response Both Acknowledge that
`the Final “Wherein” Clause Should Be Given Patentable Weight
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`Exemplary claim 1 recites:
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`1. A method of reducing the incidence of NSAID-associated gastric
`ulcers in patients taking low dose aspirin who are at risk of developing
`such ulcers, wherein the method comprises administering to said
`patient in need thereof a pharmaceutical composition in unit dose
`form comprising:
`(a) 20 mg of esomeprazole, or pharmaceutically acceptable salt
`thereof, in a form and route sufficient to raise the gastric pH of
`said patient to at least 3.5 upon administration of one or more of
`said unit dosage forms, and
`(b) 500 mg of naproxen, or pharmaceutically acceptable salt
`thereof;
`wherein said unit dose form provides for coordinated release of
`the esomeprazole and the naproxen,
`wherein at
`least a portion of said esomeprazole, or
`pharmaceutically acceptable salt thereof, is released independent of
`the pH of the surrounding medium,
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`Patent No. 8,945,621
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`wherein the unit dosage form releases less than 10% of the
`naproxen or a pharmaceutically acceptable salt thereof after 2 hours
`when tested using the USP Paddle Method in 1000 ml of 0.1N HCl at
`75 rpm at 37º C.+/-0.5º C.,
`wherein said pharmaceutical composition in unit dose form
`reduces the incidence of NSAID-associated ulcers in said patient and
`wherein administration of the unit dose form is more
`effective at reducing the incidence of the NSAID-associated ulcers
`in patients taking LDA than in patients not taking LDA who are
`administered the unit dose form.
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`(Ex. 1001, 26:61-27:20 (emphasis added).)
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`The final “wherein” clause was addressed in both the Petition and the
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`Preliminary response. The Petition unsuccessfully argued that the Plachetka,
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`Graham, and Goldstein references teach or suggest the limitation recited in the
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`final “wherein” clause. Indeed, the Petition included an entire section devoted
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`solely to the final “wherein” clause of claim 1. Petition (Paper No. 1) at 17-19. In
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`addition, the Petitioner’s expert declarant, Leon Shargel, acknowledged that the
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`final “wherein” clause is entitled to patentable weight, stating: “It is my
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`understanding that the applicant obtained the ’621 Patent based on adding the
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`limitation ‘wherein administration of the unit dose form is more effective at
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`reducing the incidence of the NSAID-associated ulcers in patients taking LDA than
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`in patients not taking LDA who are administered the unit dose form’ or a similar
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`Patent No. 8,945,621
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`limitation.” (Ex. 1003, ¶ 40.) Thus, the Petitioner plainly recognized that the final
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`“wherein” should be afforded patentable weight.
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`The Preliminary Response also acknowledges that the final “wherein” clause
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`recites a limitation entitled to patentable weight. The Preliminary Response argued
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`that the cited references do not render the ’621 patent obvious for a number of
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`reasons, including the fact that challenged claims require the dosage form to be
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`more effective at reducing the incidence of NSAID-associated ulcers in patients
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`taking LDA than in patients not taking LDA, as described by the final “wherein”
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`clause. See Patent Owner’s Preliminary Response (“Preliminary Response”)
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`(Paper No. 15) at 3-4, 28-29 (citations omitted); (see also Ex. 1001 at 17:21-44,
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`Table 3, Table 5). Thus in their respective submissions, both the Petitioner and the
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`Patent Owner acknowledged that the final “wherein” clause is entitled to
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`patentable weight. There was no dispute between the Parties on that point.
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`B.
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`The Examiner Added the Final “Wherein” Clause
`Examiners Amendment
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`in an
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`The Board agreed with the Patent Owner that the Petitioner failed to
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`establish that any of the cited prior art—including Plachetka, Graham, and
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`Goldstein—teach or suggest that “‘administration of the unit dose form is more
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`effective at reducing the incidence of the NSAID-associated ulcers in patients
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`Patent No. 8,945,621
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`taking LDA than in patients not taking LDA who are administered the unit dose
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`form,’” as required by claims 1, 8, 15, and 16. Decision at 14.
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`As set forth in the Patent Owner’s Preliminary Response, this is precisely
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`what the Examiner concluded during prosecution. See Preliminary Response at 3-
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`4, 28-29. Describing an interview with the applicants, the Examiner stated:
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`“Examiner and Applicants representative discussed claim amendments which
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`would render the claims commensurate in scope with the demonstrated unexpected
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`results. An agreement was reached which is reflected in the attached Examiners
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`Amendment.” (9/25/14 Examiner-Initiated Interview Summary, Ex. 1002 Pt. A at
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`27.)
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`The Examiner subsequently amended the independent claims in an
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`Examiner’s Amendment, adding the “wherein” clause at issue here. (9/25/14
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`Examiner’s Amendment, Ex. 1002 Pt. A at 24.) Specifically, the Examiner added
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`the phrase “and wherein administration of the unit dose form is more effective at
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`reducing the incidence of the NSAID-associated ulcers in patients taking LDA than
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`in patients not taking LDA who are administered the unit dose form” to pending
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`claims 1, 25, 64, and 65 (which issued as claims 1, 8, 15, and 16). (Id. at 24-26.)
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`The Examiner stated in the Notice of Allowance: “The following is an examiner’s
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`statement of reasons for allowance: Applicants have demonstrated the unexpected
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`result that patients taking low dose aspirin who were administered the instantly
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`Patent No. 8,945,621
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`recited dosage form (PN400) showed a lower incidence of gastric ulcers than non-
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`aspirin using patients administered PN400.” (9/25/14 Notice of Allowance, Ex.
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`1002 Pt. A at 2.)
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`C. The Final “Wherein” Clause Is Entitled to Patentable Weight
`Because it Was Added by the Examiner as a Condition for
`Allowance
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`The Examiner’s statement of reasons for allowance focused on the
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`unexpected result that patients taking LDA in combination with the claimed
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`pharmaceutical composition demonstrated a lower incidence of gastric ulcers than
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`patients taking the claimed pharmaceutical composition but not LDA. As such, the
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`associated “wherein” clause directed to this unexpected result, as added by the
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`Examiner, should be afforded patentable weight.
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`As the Board noted, a “whereby” or “wherein” clause “that merely states the
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`results of the limitations in the claim adds nothing to the patentability or substance
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`of the claim.” Texas Instruments, Inc. v. U.S. Int’l Trade Comm’n, 988 F.2d 1165,
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`1172 (Fed. Cir. 1993). The “whereby” clause at issue in Texas Instruments,
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`however, merely summarized the result of the claimed process. The clause did not
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`purport to describe any unexpected effects of the claimed process. See also
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`Minton v. Nat’l Ass’n of Secs. Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003)
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`(holding that mere “laudatory” terms that characterized the result of the executing
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`step were not limiting and therefore not entitled to patentable weight).
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`Patent No. 8,945,621
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`But, when, as here, a “wherein” clause is added during prosecution by the
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`Examiner to recite unexpected results in the claim language, such language must
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`limit the claim scope, and is therefore entitled to patentable weight. See, e.g.,
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`Research Found. of State Univ. of New York v. Mylan Pharm. Inc., 723 F. Supp. 2d
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`638, 653-54 (D. Del. 2010) (holding that a “wherein” clause added by the
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`examiner during prosecution to overcome prior art was limiting and entitled to
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`patentable weight). See also Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 1330
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`(Fed. Cir. 2005) (per curiam) (distinguishing Minton and finding a “whereby”
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`clause limiting to the method as claimed because it was described in the
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`specification and prosecution history as an “integral part of the invention”).
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`In Biosig Instruments, Inc. v. Nautilus, Inc., 783 F.3d 1374 (Fed. Cir. 2015),
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`the Federal Circuit found a “whereby” clause that described the function
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`necessarily following from the claimed structure to be limiting. Id. at 1383. The
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`court stated, “‘Even more significantly, the PTO examiner found this function
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`[described in the whereby clause] to be ‘crucial’ as a reason for overcoming the
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`cited prior art and confirming the patentability of the asserted claims upon
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`reexamination . . . Thus, the recitation of this function . . . is highly relevant in
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`ascertaining the proper bounds of [the claim element].’” Id. (citing Biosig
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`Instruments, Inc. v. Nautilus, Inc., 715 F.3d 891, 900 (Fed. Cir. 2013), vacated and
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`remanded on other grounds, 134 S. Ct. 2120 (2014)). See also Thermalloy Inc. v.
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`9
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`Case No. IPR2015-01718
`Patent No. 8,945,621
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`Aavid Eng'g, Inc., 935 F. Supp. 55, 60 (D.N.H. 1996), amended by, 935 F. Supp.
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`63 (D.N.H. 1996), aff’d, 121 F.3d 691 (Fed. Cir. 1997) (“The terms of the whereby
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`clause must be regarded as an essential feature of the invention when a whereby
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`clause is used to distinguish the invention over the prior art during prosecution of
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`the patent.”); Eltech Sys. Corp. v. PPG Indus., Inc., 710 F. Supp. 622, 633 (W.D.
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`La. 1988) (“When the terms appearing in the whereby clause of a claim were
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`emphasized as being effective for distinguishing over the prior art and in securing
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`the allowance of that claim during the prosecution of the patent, those terms must
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`be deemed an essential feature necessary to the establishment of infringement.”)
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`aff’d, 903 F.2d 805 (Fed. Cir. 1990).
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`Here, the Examiner’s addition of the final “wherein” clause during
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`prosecution to limit the claim scope to the unexpected result cited by the Examiner
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`cannot be overlooked or disregarded. Since the Board has already concluded that
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`Petitioner failed to establish that any of the cited references teach or suggest the
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`final “wherein” clause of independent claims 1, 8, 15, and 16, this action by the
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`Examiner must be considered by the Board as affording this clause patentable
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`weight, and not doing so would be contrary to controlling Federal Circuit
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`authority. As such, Petitioner has failed to demonstrate a reasonable likelihood
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`that it would prevail with respect to any of the claims challenged in the Petition.
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`Case No. IPR2015-01718
`Patent No. 8,945,621
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`IV. THE PATENTABLE WEIGHT OF THE FINAL “WHEREIN”
`CLAUSE SHOULD BE DECIDED AT THIS STAGE OF THE
`PROCEEDING
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`The Board has been tasked with securing “the just, speedy, and inexpensive
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`resolution of every proceeding,” brought before it. 37 C.F.R. § 42.1(b). Deciding
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`this issue—whether or not to give patentable weight to the final “wherein”
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`clause—at this stage of the proceedings is consistent with this mandate. The Board
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`has already concluded that the cited references do not teach or suggest this key
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`limitation. This is an issue of claim construction that can and should be resolved
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`without trial. Thus, it would be a significant waste of resources to go forward with
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`a trial, if the Board’s ultimate conclusion is that the “wherein” clause is entitled to
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`patentable weight. The Board has the necessary information before it to render a
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`decision on this issue now.
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`V. CONCLUSION
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`For the foregoing reasons, Patent Owner requests that the Board deny
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`Grounds 1 and 2 in the Petition and decline to institute inter partes review of the
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`’621 patent.
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`Date: March 4, 2016
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`Respectfully submitted,
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` /Lauren L. Stevens/
`Lauren L. Stevens
`Reg. No. 36,691
`Counsel for Patent Owner
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`11
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`Case No. IPR2015-01718
`Patent No. 8,945,621
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`CERTIFICATION OF SERVICE UNDER 37 C.F.R. §§ 42.6(e)
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`
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`I, Lauren L. Stevens, hereby certify that on this 4th day of March
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`2016, the foregoing Request for Rehearing was served electronically via email on
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`the following counsel for the Petitioner:
`
`Amy E. LaValle
`amy.lavalle@wickphillips.com
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`Jerry C. Harris, Jr.
`jerry.harris@wickphillips.com
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`CFAD.IPRs@wickphillips.com
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`Wick Phillips Gould & Martin, LLP
`3131 McKinney Avenue, Suite 100
`Dallas, TX 75204
`
` /Lauren L. Stevens/
`Lauren L. Stevens
`Reg. No. 36,691
`Counsel for Patent Owner
`
`BY:
`
`
`
`
`Date: March 4, 2016
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`
`
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`
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`12
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