UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`GRAY SQUARE PHARMACEUTICALS, LLC
`Petitioner,
`v.
`
`POZEN INC.
`Patent Owner.
`
`Case IPR2016-00191
`Patent 7,332,183
`
`
`Request for Rehearing Under 37 C.F.R. § 42.71(d)
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`
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`GRAY SQUARE PHARMACEUTICALS, LLC
`Petitioner,
`v.
`
`POZEN INC.
`Patent Owner.
`
`Case IPR2016-00191
`Patent 7,332,183
`
`
`Request for Rehearing Under 37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.71(d), Gray Square Pharmaceuticals, LLC
`
`(“Petitioner”) respectfully requests rehearing of the Board’s Decision (Paper No.
`
`10, entered May 6, 2015; “Dec.”) denying institution of Petitioner’s petition for
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`inter partes review of claims 1-2 of the ‘183 Patent (“Pet.”). The Board reviews a
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`request for rehearing for an abuse of discretion. An abuse of discretion “occurs
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`when a court misunderstands or misapplies the relevant law or makes clearly
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`erroneous findings of fact.” Renda Marine, Inc. v. U.S., 509 F.3d 1372, 1379 (Fed.
`
`Cir. 2007).
`
`I.
`
`
`
`The Board’s construction of “dissolve independently” overlooked an
`express teaching from the specification that this limitation can be
`“achieved by placing the individual layers in a side-by-side
`arrangement.”
`
`The Board construed the phrase “dissolution of said naproxen occurs
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`independently of said triptan” (hereinafter, the “dissolve independently” limitation)
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`as follows: “a dissolution profile such that complete dissolution of naproxen and
`
`triptan when the drugs are given in the combination tablet requires the same
`
`amount of time ± 10% as when the same amount of naproxen or triptan is given
`
`alone.” (Dec. p. 8). This construction was not proposed either the Petitioner or the
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`Patent Owner.
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`The Board adopted this construction on the ground that the Patent Owner
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`purportedly “acted as its own lexicographer by defining ‘dissolve independently’
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`in the Specification.” (Dec. at 6). For support, the Board relied upon the following
`2
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`
`
`
`
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`passage from the specification:
`
`The layers should be arranged such that the individual therapeutic
`agents dissolve independently of one another, i.e., dissolution should
`occur at approximately the same rate as would occur if the drugs were
`given separately. In this context, “approximately the same rate”
`indicates that the time for complete dissolution of agent when drugs
`are given in the combination tablet should require the same amount of
`time ±10% as when the same amount of agent is given alone.
`
`
`(Dec. p. 6, quoting Ex. 1001, 2:46-54).
`
`
`
`However, the Board overlooked the critical sentence immediately following
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`this passage, and in so doing, the Board misapprehended the Patent Owner’s
`
`express definition of the “dissolve independently” limitation. Specifically, the
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`Board overlooked the sentence in bold below:
`
`The layers should be arranged such that the individual therapeutic
`agents dissolve independently of one another, i.e., dissolution should
`occur at approximately the same rate as would occur if the drugs were
`given separately. In this context, “approximately the same rate”
`indicates that the time for complete dissolution of agent when drugs
`are given in the combination tablet should require the same amount of
`time ±10% as when the same amount of agent is given alone. This
`can be achieved by placing the individual layers in a side-by-side
`arrangement, as opposed, for example, in a single layer tablet matrix
`containing both agents or one layer forming a core surrounded by the
`other layer.
`
`
`
`3
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`
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`(Ex. 1001, 2:46-58).
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`This sentence (in bold) is part of the Patent Owner’s purported definition of
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`“dissolve independently.” In other words, even if the Patent Owner defined
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`“dissolve independently” to mean “complete dissolution of agent when drugs are
`
`given in the combination tablet should require the same amount of time ±10% as
`
`when the same amount of agent is given alone,” as construed by the Board, the
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`Patent Owner expressly and unequivocally also defined how this limitation can be
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`achieved: “This can be achieved by placing the individual layers in a side-by-side
`
`arrangement.”
`
`
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`The Board’s misapprehension of the full scope of Patent Owner’s
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`lexicography of the “dissolve independently” limitation was material to its decision
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`denying institution. The Board faulted each of Petitioner’s proposed grounds of
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`unpatentability for the same reason: because the Petitioner allegedly failed to
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`identify evidence to meet the Board’s construction of “dissolve independently.”
`
`The Board repeatedly stated:
`
`Petitioner fails to identify sufficient evidence demonstrating that
`[Ouali (p. 10, ground 1); Elger (p. 12-13, ground 2); Desai (p. 16,
`ground 4)1] discloses or suggests bilayer tablets having a dissolution
`
`
`1 For ground 3, rather than repeating the quote above again, the Board stated:
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`
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`4
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`
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`
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`profile such that complete dissolution of the ingredients when given in
`the combination tablet requires approximately the same amount of
`time as when the ingredients are given alone.
`(Dec. pp. 10, 12-13, 16).
`
`
`
`The Board reasoned that Petitioner failed to identify sufficient evidence
`
`demonstrating its construction of “dissolve independently” because Petitioner did
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`not identify evidence comparing dissolution rates of ingredients in a multilayer
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`tablet versus dissolution rates for those ingredients alone. The Board repeatedly
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`stated:
`
`Petitioner does not direct us to any test results comparing dissolution
`rates of [Ouali’s (p. 10, ground 1); Elger’s (p. 13, ground 2); Desai’s
`(p. 16, ground 4)2] ingredients combined in a multilayer tablet with
`dissolution rates of those same ingredients on their own.
`
`
`(Dec. p. 10, 13, 16).
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`But this evidence is not necessary. Test results, or similar evidence
`
`comparing dissolution rates of ingredients combined in a multilayer tablet with
`
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`“Petitioner’s argument is no more persuasive here than it was when presented
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`in combination with Plachetka.” (Dec. p. 14).
`
` 2
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` For ground 3, rather than repeating the quote above again, the Board stated:
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`“Petitioner’s argument is no more persuasive here than it was when presented
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`in combination with Plachetka.” (Dec. p. 14).
`5
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`
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`dissolution rates of those same ingredients on their own, is not necessary under the
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`Patent Owner’s express definition of the phrase “dissolve independently.” As
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`shown above, the Patent Owner expressly taught that this evidence is not necessary
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`because the limitation “can be achieved by placing the individual layers in a side-
`
`by-side arrangement.” Thus, the Patent Owner expressly taught that the only
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`evidence necessary to meet the “dissolve independently” limitation—which
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`correspondingly equates to the Patent Owner’s lexicographic construction of the
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`“dissolve independently” limitation—is evidence that “the individual layers [are
`
`placed] in a side-by-side arrangement.”
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`Petitioner identified this evidence in its petition. (See Pet. grounds 1-4). In
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`fact, Petitioner disclosed prior art that expressly taught a bilayer formulation of
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`naproxen and triptan, as required by the challenged claims. (Pet. ground 3, p. 48).
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`Therefore, in light of the Board’s misapprehension of the Patent Owner’s own
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`lexicographic statements, and in light of the Board overlooking a key sentence
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`from the Patent Owner’s lexicographic definition of the “dissolve independently”
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`limitation, Petition respectfully requests rehearing and institution.
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`The Board may deny this rehearing request because adding the sentence
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`“[t]his can be achieved by placing the individual layers in a side-by-side
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`arrangement” to the construction of “dissolve independently” would purportedly
`
`render the “dissolve independently” limitation redundant. More specifically, the
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`6
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`
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`Board may point out that the claims already require individual layers in a side-by-
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`side arrangement (Ex. 1001 col. 18:35-37), and thus, that would effectively read
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`out the “dissolve independently” limitation from the claim.
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`But denying rehearing on this ground would be wrong because the
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`alternative would be impractical. It would require adopting a claim construction
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`that is inconsistent with the Patent Owner’s very own teaching in its specification.
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`In other words, even though the Patent Owner expressly taught that the “dissolve
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`independently” limitation can be met “by placing the individual layers in a side-
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`by-side arrangement” (Ex. 1001 col. 2:54-55), the Board’s construction—i.e., the
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`one adopted in its decision denying institution—would require that it cannot be.
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`That would be completely opposite to and inconsistent with the Patent Owner’s
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`express teaching.
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`The Board may also deny this rehearing request on the ground that the
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`sentence that the Petitioner identifies as overlooked by the Board (“This can be
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`achieved by placing the individual layers in a side-by-side arrangement . . .”) was
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`not actually overlooked. That is because it was not identified in Petitioner’s
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`petition for inter partes review of the ‘183 Patent. However, the Board adopted a
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`claim construction of the “dissolve independently” limitation that was not
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`proposed by either the Petitioner or the Patent Owner. That claim construction was
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`7
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`based on a sentence from the specification3 that was not disclosed in the
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`Petitioner’s petition or the Patent Owner’s Preliminary Response. Petitioner did its
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`best to anticipate alternative claim constructions, and specifically those it believed
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`to be consistent with the broadest reasonable interpretation standard. It devoted the
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`majority of space in its page-limited petition to unpatentability arguments it
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`believed consistent with that standard. Given that petitioners do not have the
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`opportunity to seek appellate review of an institution decision (In re Cuozzo Speed
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`Techs., LLC, 778 F.3d 1271 (Fed. Cir. 2015)), it is unfair and prejudicial to deny a
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`rehearing request on the grounds that Petitioners failed to anticipate all possible
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`claim constructions and respond to them in a petition for inter partes review.
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`It would also be unfair because it is at odds with the Patent Owner’s express
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`teaching. The Board construed the challenged claims to require evidence from the
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`prior art, such as “test results comparing dissolution rates of [Ouali’s] ingredients
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`combined in a multilayer tablet with dissolution rates of those same ingredients on
`
`their own.” (See Dec. p. 10, 13, 16). However, the Patent Owner never did this in
`
`
`3 That sentence is: “In this context, ‘approximately the same rate’ indicates that the
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`time for complete dissolution of agent when drugs are given in the combination
`
`tablet should require the same amount of time ±10% as when the same amount of
`
`agent is given alone.” (Dec. at 6).
`
`
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`8
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`the course of applying for its patent. Although the Patent Owner disclosed
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`examples and test results in its specification, none of them compared dissolution
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`rates for ingredients in the bilayer tablet with rates for those ingredients actually on
`
`their own.4 There is a clear reason for this, namely, the Patent Owner did not view
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`this comparison as a required element of its claims. That is because the Patent
`
`Owner taught that the “dissolve independently” limitation “can be achieved by
`
`placing the individual layers in a side-by-side arrangement.” (Ex. 1001 col. 2:54-
`
`55).
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`Thus, if this rehearing request is denied, the Board will have effectively
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`adopted a construction that was not proposed by either the Petitioner or the Patent
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`Owner, which relied upon a passage from the specification not cited by the
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`Petitioner or the Patent Owner, which overlooked a key sentence from that
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`passage, and where that sentence illustrates how the Patent Owner actually defined
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`“dissolve independently,” and that also shows how the Board gravely
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`4 Instead, the disclosed examples compare dissolution rates for a multilayer tablet
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`with naproxen and sumatriptan with dissolution rates of a tablet with those
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`ingredients in physical admixture, and with dissolution rates for a tablet with a
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`naproxen core surrounded by a sumatriptan film. (Ex. 1001 col. 10:5-11; see also
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`Ex. 1004 at 6-7).
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`9
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`
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`misapprehended the passage from the specification it relied upon to suggest that
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`the Patent Owner acted as its own lexicographer. The Board will have added a
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`limitation to the claim that is inconsistent with the Patent Owner’s express
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`teachings, and faulted Petitioner’s grounds for unpatentability for lacking test
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`results and evidence that the Patent Owner did not teach to be necessary.
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`Petitioner is mindful that rehearing requests are not an avenue to disagree
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`with the Board’s assessment of arguments or weighing of evidence. That,
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`however, is not what Petitioner does here. Petitioner is not rearguing its proffered
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`construction for the “dissolve independently” limitation. Nor is Petitioner
`
`contending that the Patent Owner did not act as its own lexicographer in the course
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`of defining the “dissolve independently” limitation, as found by the Board. This
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`rehearing request concedes that, and does not challenge that analysis by the Board
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`in its decision.
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`Instead, Petitioner contends that in the course of its own analysis, which was
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`admittedly a departure from the Petitioner’s analysis of the “dissolve
`
`independently” limitation, the Board overlooked and misapprehended a key
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`sentence from the specification. If the Board does actually agree that it overlooked
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`that sentence, and if the Board does actually agree that it misapprehended the
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`passage from the specification relied upon for its construction of the “dissolve
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`independently” limitation, it would be a grave injustice to deny this rehearing
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`10
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`request on the ground that the Petition failed to anticipate the Board’s
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`construction—which was not proposed by either party to this proceeding—and
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`failed to identify a response to that construction in its petition.
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`II. The Board overlooked argument and case-law in the Petition showing
`that the limitation “such that the dissolution of said naproxen occurs
`independently of said triptan” is not a patentable distinction.
`
`
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`The Board’s decision denying institution relied upon the ground that none of
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`Petitioner’s cited prior art rendered obvious the “dissolve independently”
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`limitation. (See Dec. passim). That limitation recites that the ingredients are
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`arranged side-by-side “such that the dissolution of said naproxen occurs
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`independently of said triptan,” (previously defined herein as the “dissolve
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`independently” limitation). (See Ex. 1001, claim 1). However, the Board
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`overlooked and misapprehended the Petitioner’s argument in its petition that the
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`“dissolve independently” limitation is not a patentable distinction.
`
`Petitioner argued that “‘independent’ dissolution of the ingredients in the
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`respective layers of a bilayer tablet was an inherent property of that formulation,”
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`(Pet. pp. 38-39), and the Board found this argument unpersuasive for purportedly
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`lacking evidence (Dec. p. 11). However, that finding overlooked and
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`misapprehended Petitioner’s argument.
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`Petitioner argued that the “dissolve independently” limitation is not a
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`patentable distinction because it is a property of a tablet formulation that
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`
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`11
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`
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`previously existed. Specifically, Petitioner argued, “[t]he general principle that a
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`newly-discovered property of the prior art cannot support a patent on that same art
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`is not avoided if the patentee explicitly claims that property.” (Pet. p. 39).
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`Petitioner cited for support Abbott Labs. v. Baxter Pharm. Prods., 471 F.3d 1363,
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`1367 (Fed. Cir. 2006)). (Pet. p. 39).
`
`In Abbott Labs, the patented claims were directed to an anesthetic
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`composition containing a quantity of sevoflurane and a Lewis acid inhibitor (such
`
`as water) that was claimed “in an amount effective to prevent degradation by a
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`Lewis acid of said quantity of sevflurane.” Abbott Labs, 471 F.3d at 1363. The
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`prior art “disclosed a composition of water-saturated sevoflurane that met all the
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`limitations of the asserted claims,” but did not teach the property that it was
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`“effective to prevent degradation by a Lewis acid of said quantity of sevflurane.”
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`Id. The Federal Circuit held this was not a patentable distinction. The Court
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`emphasized that “[o]ur cases have consistently held that a reference may anticipate
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`even when the relevant properties of the thing disclosed were not appreciated at the
`
`time.” Id. The Court also emphasized that this “rule has been repeatedly
`
`confirmed and applied by this court.” Id.5 The Federal Circuit in Abbott Labs also
`
`
`5 The Court cited the following cases applying the rule: “See, e.g., In re Crish, 393
`F.3d 1253, 1258-59 (Fed. Cir. 2004) (citing cases; holding asserted claims
`covering a gene's nucleotide sequence anticipated where the gene, though not its
`12
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`
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`held that simply claiming a property of a previously known structure does not
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`make it patentable. “The general principle that a newly-discovered property of the
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`prior art cannot support a patent on that same art is not avoided if the patentee
`
`explicitly claims that property.” Id. Based on this precedent, the Court in Abbott
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`Labs held the asserted patent invalid.
`
`
`particular sequence, was already known to the art); In re Cruciferous Sprout
`Litig., 301 F.3d 1343, 1349-50 (Fed. Cir. 2002) (inventor's recognition of
`substances that render broccoli and cauliflower particularly healthy does not permit
`patent on identifying broccoli seeds or preparing broccoli as a food product); Atlas
`Powder, 190 F.3d at 1347-1350 (holding asserted claims covering air mixed into
`an explosive composition anticipated by prior art that necessarily also contained air
`as claimed, even though benefits of the air were not recognized). Indeed, the rule
`did not originate with Titanium Metals. See Ansonia Brass & Copper Co. v. Elec.
`Supply Co.,144 U.S. 11, 18, 12 S.Ct. 601, 36 L.Ed. 327 (1892) (“[T]he application
`of an old process or machine to a similar or analogous subject, with no change in
`the manner of application and no result substantially distinct in its nature, will not
`sustain a patent even if the new form of result had not before been
`contemplated.”); In re Pearson, 494 F.2d 1399, 1403 (C.C.P.A.1974) (inventor's
`recognition that prior-art compound inhibited defects in peanut plants did not
`suffice to grant patent protection on that compound); In re Benner, 36 C.C.P.A.
`1081, 174 F.2d 938, 942 (1949) (“[N]o provision has been made in the patent
`statutes for granting a patent upon an old product based solely upon discovery of a
`new use for such product.”).”
`
`
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`13
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`
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`Abbott Labs also relied heavily on and discussed extensively Titanium
`
`Metals Corp. v. Banner, 778 F.2d 775 (Fed. Cir. 1985), which addressed a patent
`
`claiming an alloy with specific weight percentages of nickel, molybdenum, iron
`
`and titanium. The claims also recited, “said alloy being characterized by good
`
`corrosion resistance in hot brine environments.” Id. at 776. A prior art referenced
`
`indisputably anticipated the claimed metal alloy ingredients and recited weight
`
`percentages, but did not teach “an alloy with previously unknown corrosion
`
`resistance and workability properties.” Abbott Labs, 471 F.3d at 1363. The Court
`
`in Abbott Labs stated, “[d]espite the fact that ‘the applicants for patent had
`
`discovered or invented and disclosed knowledge which is not to be found in the
`
`reference,’ we held that the Russian article anticipated the asserted patent claims.
`
`Id. (quoting Titanium Metals, 778 F.2d at 782). More specifically, the Court in
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`Titanium Metals held, “it is immaterial, on the issue of their novelty, what inherent
`
`properties the alloys have or whether these applicants discovered certain inherent
`
`properties.” Titanium Metals, 778 F.2d at 784.
`
`
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`Here, the Board overlooked the same argument made by Petitioner in its
`
`petition as made in Abbott Labs. Even if the petition lacked evidence showing
`
`that, as the Board found, “independent dissolution of ingredients in a bilayer tablet
`
`is an inherent property of that formulation,” (Dec. p. 11), the Abbott Labs rule does
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`not require a finding of inherency to apply. Indeed, Abbott Labs relied heavily on
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`14
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`
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`Titanium Metals, which after concluding the prior art taught the claimed alloy
`
`ingredients and weight percentages, held “it is immaterial, on the issue of their
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`novelty, what inherent properties the alloys have or whether these applicants
`
`discovered certain inherent properties.” Titanium Metals, 778 F.2d at 784. Abbott
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`Labs concluded that “a reference may anticipate even when the relevant properties
`
`of the thing disclosed were not appreciated at the time.” Abbott Labs 471 F.3d at
`
`1367.
`
`Petitioner disclosed prior art showing that a bilayer tablet structure of
`
`naproxen and sumatriptan was obvious. (See Pet. grounds 1, 2 and 4). In fact,
`
`Petitioner disclosed prior art that expressly taught a bilayer formulation of
`
`naproxen and triptan, as required by the challenged claims. (Pet. ground 3, p. 48).
`
`Under Abbott Labs, the art cited in those grounds (especially ground 3) anticipate
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`and render obvious the challenged claims of the ‘183 Patent regardless of whether
`
`the “dissolve independently” limitation is an inherent property or not. That is
`
`because it is still a “relevant propert[y] of the thing disclosed.” The claimed
`
`requirement (“such that the dissolution of said naproxen occurs independently of
`
`said triptan”) is a property of the thing disclosed. To the extent that thing disclosed
`
`(the side-by-side arrangement of naproxen and triptan) was taught in the prior art,
`
`simply claiming a property of that thing is not a patentable distinction. See Abbott
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`Labs 471 F.3d at 1367.
`
`
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`15
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`
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`Petitioner made this argument in its petition. Petitioner pointed out that,
`
`during prosecution, the Patent Owner claimed that they “are not attempting to
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`prevent reaction of two chemical entities, but rather to provide for superior release
`
`characteristics.” (Pet. p. 38-39, citing Ex. 1004, FH183 Amendment 4/5/2007, at
`
`7). Next, in its petition, Petitioner argued: “But even if that is true, that does not
`
`yield a patentable distinction. To the extent the claimed ‘multilayer pharmaceutical
`
`tablet’ recited in the challenged claims of the ‘183 Patent ‘provide for superior
`
`release characteristics,’ that is not a patentable distinction.” (Pet. p. 39). Petitioner
`
`cited Abbott Labs. (Id.).
`
`The Board’s decision denying institution overlooked this argument,
`
`overlooked the citation to Abbott Labs, and misapprehended the significance of
`
`this argument as not simply an “inherency” argument, but an argument about how
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`the Federal Circuit has characterized whether patent claims can be patentable
`
`where they claim known structure, but simply recite a previously undisclosed
`
`property of that structure.
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`Conclusion
`
`For the foregoing reasons, Petitioner respectfully requests rehearing and
`
`institution based on Grounds 1-4.
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`16
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`Respectfully submitted,
`
`
`Zachary D. Silbersher
`Kroub, Silbersher & Kolmykov PLLC
`305 Broadway, 7th Fl.
`New York, NY 10007
`Tel: (212) 323-7442
`Email: zsilbersher@kskiplaw.com
`
`Reg. No. 62,090
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`17
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`Dated: June 3, 2016
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`CERTIFICATE OF SERVICE
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`
`
`
`
`Pursuant to 37 C.F.R. §§ 42.6, the undersigned hereby certifies that a copy
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`of this Request for Rehearing Under 37 C.F.R. § 42.71(d) has been served
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`electronically upon the following email addresses provided in Patent Owner’s
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`Mandatory Notices Under 37 C.F.R. § 42.8.(a)(2).
`
`PozenIPR@fchs.com
`Dominick A. Conde
`Brendan M. O’Malley, Ph.D
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`
`and
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`PozenIPR@bakerbotts.com
`Stephen M. Hash, Ph.D
`Jeffrey S. Gritton
`Baker Botts LLP
`98 San Jacinto Blvd Suite 1500
`Austin, TX 78701-4078
`
`Dated: June 3, 2016
`
`
`Zachary D. Silbersher
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`
`
`18
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