Paper No. 38
` Entered: November 10, 2016
`
`Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS VII, LLC,
`Petitioner,
`
`v.
`
`POZEN INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01718
`Patent 8,945,621 b2
`____________
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`SCHEINER, Administrative Patent Judge.
`
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
` Entered: November 10, 2016
`
`Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS VII, LLC,
`Petitioner,
`
`v.
`
`POZEN INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01718
`Patent 8,945,621 b2
`____________
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`SCHEINER, Administrative Patent Judge.
`
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`IPR2015-01718
`Patent 8,945,621 B2
`
`On March 4, 2016, Patent Owner filed a Request for Rehearing
`
`(Paper 19, “Reh’g Req.”) of our Decision instituting an inter partes review
`(Paper 17, “Decision” or “Dec.”) of claims 1–16 of U.S. Patent No.
`8,945,621 B2 (Ex. 1001, “the ’621 patent”). Petitioner, with our
`authorization, filed an Opposition to Patent Owner’s Request for Rehearing
`of the Decision to Institute. Paper 20.
`We deny Patent Owner’s Request for Rehearing for the reasons set
`forth below.
`
`STANDARD OF REVIEW
`When reconsidering a decision on institution, the Board reviews the
`
`decision for an abuse of discretion. See 37 C.F.R § 42.71(c). An abuse of
`discretion occurs if a decision is based on an erroneous interpretation of law,
`if a factual finding is not supported by substantial evidence, or if the
`decision represents an unreasonable judgment in weighing relevant factors.
`See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir.
`2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re
`Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of
`showing that a decision should be modified lies with the party challenging
`the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756,
`48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party
`must, in relevant part, “specifically identify all matters the party believes the
`Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d); Office Patent
`Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Patent Owner’s
`arguments with these principles in mind.
`
`
`
`2
`
`
`
`IPR2015-01718
`Patent 8,945,621 B2
`
`
`ANALYSIS
`The challenged claims are directed to a method of reducing the
`
`incidence of NSAID-associated gastric ulcers in patients taking low dose
`aspirin comprising administering esomeprazole and naproxen in a specified
`unit dose form. The final clause of each of independent method claims 1, 8,
`15, and 16 reads as follows: “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.” Ex. 1001, 27:16–20, 59–63, 28:36–39, 60–63.
`In our Decision, we determined that Petitioner had established
`sufficiently for purposes of institution that one of ordinary skill in the art
`would have had a reason to administer the specific esomeprazole/naproxen
`unit dose form recited in the claims to patients taking low dose aspirin,
`based on the cited prior art. Dec. 11–12, 18. However, we agreed with
`Patent Owner that Petitioner had not established—either in the Petition, or
`the portions of Dr. Shargel’s Declaration cited in the Petition—that the prior
`art relied on would have
`led the ordinary artisan to expect that administering the specific
`unit dose form of the challenged claims to patients taking an
`NSAID and LDA would be “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,” as required by each of the challenged claims.
`Dec. 13 (citing Prelim. Resp. 12).
`
`Nevertheless, in our Decision, we noted that the U.S. Court of
`Appeals for the Federal Circuit has stated that “[a] ‘whereby’ clause that
`merely states the result of the limitations in the claim adds nothing to the
`patentability or substance of the claim.” Dec. 15–16 (citing Texas
`
`
`
`3
`
`
`
`IPR2015-01718
`Patent 8,945,621 B2
`
`Instruments, Inc. v. U.S. Int’l Trade Comm’n., 988 F.2d 1165, 1172 (Fed.
`Cir. 1993); Minton v. National Ass’n of Securities Dealers, Inc., 336 F.3d
`1373, 1381 (Fed. Cir. 2003)). We further noted “[a]lthough the challenged
`claims use the word ‘wherein,’ rather than the word ‘whereby’ as in the
`claims in Texas Instruments and Minton, the effect is the same if the clause
`merely states the result of the method steps and does not further inform the
`mechanics of the method or the structure of the dosage form administered.”
`Id. at 16. Finally, we noted that the issue of the weight to be accorded to the
`final “wherein” clause of the challenged claims had not yet been addressed
`on the record. Id. at 16.
`In its Request for Rehearing, Patent Owner contends that we
`“misinterpret[ed] the final ‘wherein’ clauses of independent claims 1, 8, 15,
`and 16.” Reh’g Req. 4. Specifically, Patent Owner contends that “[t]he
`Examiner’s statement of reasons for allowance focused on the unexpected
`result that patients taking LDA in combination with the claimed
`pharmaceutical composition demonstrated a lower incidence of gastric
`ulcers than patients taking the claimed pharmaceutical composition but not
`LDA.” Id. at 8. Patent Owner contends that “the Examiner’s addition of the
`final ‘wherein’ clause during prosecution to limit the claim scope to the
`unexpected result cited by the Examiner cannot be overlooked or
`disregarded.” Id. at 10. According to Patent Owner, “this action by the
`Examiner must be considered by the Board as affording this clause
`patentable weight, and not doing so would be contrary to controlling Federal
`Circuit authority.” Id. Patent Owner contends that Petitioner has “failed to
`establish that any of the cited references teach or suggest the final ‘wherein’
`clause of independent claims 1, 8, 15, and 16,” and, therefore, “has failed to
`
`
`
`4
`
`
`
`IPR2015-01718
`Patent 8,945,621 B2
`
`demonstrate a reasonable likelihood that it would prevail with respect to any
`of the claims challenged in the Petition.” Id.
`
`Nevertheless, we are not persuaded that we overlooked or
`misapprehended the Examiner’s reliance on the final “wherein” clause in
`allowing the application that matured into the ’621 patent. We also are not
`persuaded that the weight to be accorded the final “wherein” clause is as
`straightforward as Patent Owner proposes.
`For example, Patent Owner cites Hoffer v. Microsoft Corp., 405 F.3d
`1326, 1329 (Fed. Cir. 2005) for the proposition that a “whereby” clause
`described in the specification and/or prosecution history as an integral part
`of the invention is limiting and must be accorded patentable weight. Reh’g
`Req. 9. Hoffer however, confirms that determining whether a “wherein” or
`“whereby” clause merely “states the result of the patented process . . . [or]
`states a condition that is material to patentability” is highly fact-specific.
`Hoffer, 405 F.3d at 1329. Indeed, in Hoffer, the court found a “whereby”
`clause to be limiting not simply, as Patent Owner argues, because “it was
`described in the specification and prosecution history as an ‘integral part of
`the invention.’” Reh’g Req. 9. Rather, the court found the clause limiting
`because it required “a network of users at multiple remote user terminals
`who are ‘collectively able to concurrently engage in interactive data
`messaging’” and because “[t]his capability is more than the intended result
`of a process step; it is part of the process itself.” Hoffer, 405 F.3d at 1330
`(emphasis added). As we indicated in our Decision, it was not clear from
`the record whether the final clause of the independent claims further informs
`the mechanics of the claimed method or the structure of the dosage form
`
`
`
`5
`
`
`
`IPR2015-01718
`Patent 8,945,621 B2
`
`administered—or whether the final clause flows from what the claim
`otherwise requires. Dec. 16.
`Similarly, Patent Owner cites Biosig Instruments, Inc. v. Nautilus,
`
`Inc., 783 F.3d 1374 (Fed. Cir. 2015) for the proposition that “a ‘whereby’
`clause that describe[s] the function necessarily following from a claimed
`structure . . . [is] limiting.” Reh’g Req. 9 (citing Biosig, 783 F.3d at 1383).
`In Biosig, however, the court explained that “[t]his ‘whereby’ clause
`describes the function of substantially removing EMG signals that
`necessarily follows from the previously-recited structure consisting of the
`elongate member, the live electrode, and the common electrode.” Biosig,
`783 F.3d at 1383. The court continued, “the recitation of this function . . .
`[is] ‘highly relevant’ to ascertaining the boundaries of the ‘spaced
`relationship’ between the live and common electrodes,” (id.) and noted that
`the “spaced relationship” recited in the claims was not defined with actual
`parameters (e.g., one inch) (id.), but could be determined by calculating the
`spacing at which EMG signals are substantially removed (id. at 1384). In
`other words, in that case, the actual spacing between the live and common
`electrodes, although unspecified in the claim, was dictated by the function
`recited in the “whereby” clause. Again, in the present case, it is not clear
`from the record thus far whether the final clause of the independent claims
`further informs the mechanics of the claimed method or the structure of the
`dosage form administered—or whether the final clause flows from what the
`claim otherwise requires.
`
`As we indicated in our Decision, the issue of “whether or not the
`‘final wherein clause’ of the independent claims is entitled to patentable
`weight” is a matter for trial. Dec. 15, 20.
`
`
`
`6
`
`
`
`IPR2015-01718
`Patent 8,945,621 B2
`
`
`CONCLUSION
`We have considered Petitioner’s request for rehearing, but are not
`persuaded that we abused our discretion in instituting an inter partes review.
`ORDER
`
`It is
`
`ORDERED that Patent Owner’s request for rehearing of the Decision
`
`instituting an inter partes review of claim 1–16 of U.S. Patent No. 8,945,621
`B2 is denied.
`
`
`
`7
`
`
`
`IPR2015-01718
`Patent 8,945,621 B2
`
`
`FOR PETITIONER:
`
`Jerry Harris, Jr.
`Amy LaValle
`CFAD.IPRs@wickphillips.com
`
`Rodney B. Carroll
`rcarroll@dfw.conleyrose.com
`
`FOR PATENT OWNER:
`
`Margaret Sampson, Ph.D.
`margaret.sampson@bakerbotts.com
`
`
`Jeffrey S. Gritton
`jeff.gritton@bakerbotts.com
`
`Dennis Bennett
`dennisbennett@globalpatentgroup.com
`
`Matthew Phillips
`matthew.phillips@renaissanceiplaw.com
`
`Thomas Blinka
`zIPR2015-01718@cooley.com
`
`Stephen M. Hash, Ph.D.
`PozenVimovoBB@BakerBotts.com
`
`Ricardo Rodriguez
`zIPR2015-01718@cooley.com
`
`Lauren Stevens
`lstevens@horizonpharma.com
`
`Kevin Laurence
`kevin.laurence@renaissanceiplaw.com
`
`
`
`8
`
`
`
`IPR2015-01718
`Patent 8,945,621 B2
`
`
`
`
`James Monroe
`james.monroe@finnegan.com
`
`Danielle Pfifferling
`danielle.pfifferling@finnegan.com
`
`
`
`
`9
`
`
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