UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ARGENTUM PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`CIPLA LTD.
`Patent Owner
`
`Patent No. 8,168,620
`Issue Date: May 1, 2012
`Title: COMBINATION OF AZELASTINE AND STEROIDS
`_______________
`
`Inter Partes Review No. IPR2017-00807
`
`PETITIONER’S REQUEST FOR REHEARING UNDER 37 C.F.R. §42.71(d)
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ARGENTUM PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`CIPLA LTD.
`Patent Owner
`
`Patent No. 8,168,620
`Issue Date: May 1, 2012
`Title: COMBINATION OF AZELASTINE AND STEROIDS
`_______________
`
`Inter Partes Review No. IPR2017-00807
`
`PETITIONER’S REQUEST FOR REHEARING UNDER 37 C.F.R. §42.71(d)
`
`
`
`Pursuant to 37 C.F.R. § 42.71(d), Argentum (“Petitioner”) hereby
`
`requests rehearing of the Board’s Decision (Paper 11, entered August 21,
`
`2017;“Dec.”). The Board reviews a request for rehearing for abuse of
`
`discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be determined 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. Star Fruits S.N.C. v.
`
`U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005). As set forth below, this standard
`
`is met.
`
`Petitioner requests rehearing as to Ground 1 on the basis that the
`
`Decision misapplied the applicable law and misapprehended the prior art
`
`record evidence in relying on a finding that Segal (Ex. 1012) “literally
`
`discloses more than 800 million combinations within its broad genus” (Dec.
`
`13), rather than the 54 combinations cited in the Petition (Pet. 18-19).
`
`Specifically, the Decision erred in disregarding the express preferences set
`
`forth in Segal’s specification, as expressly quoted in Petitioner’s claim chart
`
`(id. 19-20). The Decision also erred in faulting Petitioner for “improperly
`
`reading claim 4 as dependent upon claim 2, when, in fact, claim 4 depends
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`from claim 1” (Dec. 13), because claims are properly interpreted as
`
`identifying preferred embodiments in general, irrespective of their
`
`1
`
`
`
`dependency. While Petitioner did not have an opportunity to respond to
`
`Patent Owner’s erroneous assertion that Segal disclosed more than 800
`
`million combinations of compounds (Paper 7 at 21-22, n.4), case law cited in
`
`the Petition as well as by the Board itself shows why this calculation and the
`
`analysis that followed from it are legally incorrect.
`
`I.
`
`Controlling Law, Cited in both the Petition and the Decision,
`Requires that a Prior Art Reference Be Found To Define a Limited
`Class of Species Based on Preferences Expressed in the
`Specification and/or the Claims.
`The Decision quotes WM. Wrigley Jr. Co. v. Cadbury Adams USA LLC
`
`(683 F.3d 1356 (Fed. Cir. 2012)) for the analysis of anticipation where the
`
`anticipating disclosure is found in separate lists, i.e., “whether the number of
`
`categories and components in [the single prior-art reference is] so large that
`
`the combination of [one item from each list] would not be immediately
`
`apparent to one of ordinary skill in the art.” Dec. 11. However, the Decision
`
`overlooks the additional guidance provided by Wrigley, as well the cases cited
`
`by Petitioner, regarding the starting point for conducting such a legal analysis.
`
`Petitioner cited In re Petering (301 F.2d 676, 681 (CCPA 1962)) and In
`
`re Schaumann (572 F.2d 312, 315-16 (CCPA 1978)) for the proposition that if
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`a person of ordinary skill in the art can envision each and every species of a
`
`“limited” genus taught by the prior art, the reference will anticipate each of
`
`those species if later claimed. Pet. 16, 19. Importantly, both of these
`
`2
`
`
`
`decisions relied on expressed preferences within a genus as disclosing a more
`
`limited genus, from which the species at issue were readily apparent, which
`
`was the argument presented by Petitioner here (see Pet. 19). Indeed, as noted
`
`by Petitioner (Pet. 16), the required use of such preferences in this way was
`
`expressly affirmed by the Federal Circuit in Merck v. Biocraft (874 F.2d 804,
`
`808 (Fed. Cir. 1989)), which quoted Petering in stating that “description of
`
`‘specific preferences in connection with a generic formula’ is determinative in
`
`an analysis of anticipation under 35 USC 102.” Id. (underline added).
`
`Applications of this rule are found in both cases cited in the Petition.
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`For example, in Petering, the Court found that a prior art reference anticipated
`
`the claimed isoallooxazine compounds even though the broadest genus
`
`described by the reference “perhaps contained an infinite number of
`
`compounds.” Petering, 301 F.2d at 681. Despite this large overall genus, the
`
`Court credited the prior art reference’s disclosure (in the specification) of
`
`“specific preferences [of R groups] in connection with [its] generic formula”
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`and found that such disclosure “constitutes a description of a definite and
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`limited class of compounds.” Id. Thus, as argued by Petitioner here, Petering
`
`clearly established that the disclosure of a limited number of preferred groups
`
`selected from different lists describes each possible combination derived
`
`therefrom to the POSA. Id. at 681-82 (finding that the prior art reference
`
`3
`
`
`
`“described to those with ordinary skill in this art each of the various
`
`permutations here involved as fully as if he had drawn each structural formula
`
`or had written each name”).
`
`Similarly, the Board also overlooked the import of Schaumann, which
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`Petitioner cited (Pet. 16) along with Petering, in support of the anticipation of
`
`species by a genus based on preferences described in the reference. In
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`Schaumann, Appellant’s claimed compound was found to be anticipated by a
`
`reference disclosing a genus of compounds, where some preferences within
`
`that genus were disclosed in a claim, and another limitation on that preference
`
`was disclosed in the specification. Schaumann, 572 F.2d at 317. The Court
`
`specifically rejected the reasoning relied upon in the Decision here (Dec. at
`
`12-13) that claims cannot act as independent teachings of preferences and that
`
`a POSA cannot rely on the combined teachings of the claims and specification
`
`for preferences. Id. Instead, not only did the Court rule that claims may be
`
`relied upon to indicate preferences for particular groups, but that preferences
`
`identified in the claims may also be read in conjunction with the specification
`
`to describe a more limited genus, which can then be analyzed under the rubric
`
`of Wrigley to find anticipation of a claimed species. Id. at 316-17 (finding that
`
`claim 1 of the prior art reference, read in conjunction with the specification’s
`
`4
`
`
`
`“signification” for alkyl radical, describes a very limited number of
`
`compounds, one of which anticipates the claimed species).
`
`The analysis in Wrigley (cited in the Decision) is consistent with the
`
`analyses in Petering and Schaumann, but has also been overlooked by the
`
`Board. In Wrigley, the Court found anticipation of a chewing gum claim
`
`composition that included a combination of WS-23 (a coolant) and menthol (a
`
`flavorant and a coolant). Wrigley, 683 F.3d at 1362. In its analysis, the Court
`
`relied on a prior art reference that disclosed a variety of oral compositions,
`
`including chewing gum, each containing certain required ingredients (i.e.,
`
`xylitol and copper bis-glycinate) as well as optional ingredients. Id. at
`
`1359-60. Among the optional ingredients were cooling agents; WS-23 was
`
`disclosed to be one of three preferred cooling agents. A second list provided
`
`23 “most suitable” flavoring agents that could optionally be used, including
`
`menthol. Id. at 1360.
`
`In finding the prior art anticipated the claimed combination of menthol
`
`and WS-23, the Court relied on the prior art’s express disclosure of preferred
`
`cooling agents and preferred flavoring agents, which provide a readily
`
`envisioned 69 possible combinations. Id. at 1360, 1362 (3 x 23 = 69
`
`combinations). Equally significant, the Court did not review the number of
`
`combinations that the other disclosed optional ingredients could
`
`5
`
`
`
`hypothetically be used to create, nor was the Court concerned with the
`
`number of other flavoring agents used, since such ingredients were not
`
`excluded from the claims. Id. at n.4. Thus, the Decision’s reliance on Patent
`
`Owner’s argument that Segal discloses more than 800 million possible
`
`combinations (Dec. 13 (citing Prelim. Resp. 21 & n.4)) does not comport with
`
`Wrigely—because the claims here do not exclude any of the other optional
`
`ingredients identified in Segal, Petitioner’s analysis identifying 54 relevant
`
`combination is the correct one.
`
`The case law cited by Petitioner and in the Decision establishes that (1)
`
`a prior art reference’s disclosure in the specification of preferred
`
`embodiments can and should be used to narrow the reference’s disclosure of a
`
`broad genus for purposes of analyzing anticipation under § 102; (2) the claims
`
`of a reference should be interpreted as likewise disclosing preferences within
`
`a broad genus, which preferences can be read in conjunction with other
`
`preferences taught in the specification; and (3) a reference’s disclosure of
`
`other optional ingredients is immaterial to the § 102 analysis under Wrigley
`
`where such optional ingredients are not implicated or precluded by the claim
`
`being analyzed. As discussed below, the Decision fails to correctly apply this
`
`legal analysis when it considered anticipation by Segal under Ground 1 of the
`
`Petition.
`
`6
`
`
`
`II.
`
`Under the Proper Legal Analysis Set Forth in the Petition, Segal’s
`Preferences Permit a POSA to Immediately Envision the
`Combination of Fluticasone and Azelastine
`
`The Board abused its discretion by failing to apply the proper legal
`
`analyses found in Petering, Schaumann, and Wrigley and, in so doing,
`
`misapprehending the scope of Segal’s disclosure. As a result of its erroneous
`
`anticipation analysis, the Decision incorrectly credited Patent Owner’s
`
`argument that Segal discloses more than 800 million compositions, rather
`
`than the much smaller genus of 54 compositions identified in the Petition.
`
`Compare Dec. at 13 with Pet. 17-19. As explained above, controlling
`
`precedent required consideration of all of the disclosed preferences in Segal,
`
`both in the specification and in the claims. In view of the preferences taught
`
`by Segal, the Decision erred by not finding that Segal discloses merely 54
`
`readily envisioned compositions (an even smaller genus that the 69 disclosed
`
`compositions found to anticipate in Wrigley), and therefore finding a
`
`reasonable likelihood that Segal anticipates claims 1 and 25.
`
`As described in the Petition, Segal discloses nasal formulations
`
`comprising a therapeutically effective amount of a topical anti-inflammatory
`
`agent and a therapeutically effective amount of at least one agent suitable for
`
`topical nasal administration. Pet. 15, 19-20 (quoting Ex. 1012 at 2:10-15,
`
`3:29-4:5). Thus, Segal’s nasal compositions require a topical
`
`7
`
`
`
`anti-inflammatory agent, and (as argued in the Petition at 17) Segal expressly
`
`discloses only six preferred topical anti-inflammatory agents in the
`
`specification at 2:23-26 (cited at both page 17 and pages 19-20 of the
`
`Petition). Petitioner’s claim chart expressly quotes this passage in its entirety
`
`on pp. 19-20 of the Petition. The same preference is also shown in claim 2 of
`
`Segal, which was likewise cited in the Petition. Id. at 17, 19-20. The
`
`Decision legally erred in not constraining its anticipation analysis to this more
`
`limited genus of anti-inflammatory agents. Merck, 874 F.2d at 808.
`
`It was further legal error for the Decision to overlook the preference
`
`expressed in Segal for nine antihistamines. As described and cited in the
`
`Petition at pages 17, 19 and 20, Segal discloses nine anti-histamines as being
`
`suitable for the combination with the anti-inflammatory (Segal at 3:19-20).
`
`Petitioner’s claim charts quote this disclosure in full (Pet. 19), with
`
`underlining added to highlight that azelastine is one of the
`
`specifically-identified nine anti-histamines. These same anti-histamines,
`
`including azelastine, are also taught as preferred embodiments in claim 4,
`
`which, per Schaumann, should also be considered a teaching of a preferred
`
`genus of antihistamines limited to the specifically-enumerated compounds.
`
`Schaumann at 316-17.
`
`8
`
`
`
`With respect to the alleged more than 800 million combinations of
`
`anti-inflammatory and at least one therapeutic agent, the Decision
`
`misapprehends Segal’s disclosure regarding the vastly more limited numbers
`
`of combinations disclosed. As quoted on pages 16, 19, and 20 of the Petition,
`
`Segal discloses that the at least one agent to be combined with the
`
`anti-inflammatory may be selected from eight classes of therapeutic agents.
`
`Thus, each combination of anti-inflammatory with a class of therapeutic agent
`
`would be understood by a POSA to have been disclosed, just as in Wrigley
`
`where each combination of the required ingredients with optional ingredients
`
`(e.g., flavorants and coolants) was considered disclosed. Wrigley at 1360.
`
`Hence, Segal expressly discloses the specific combination of an
`
`anti-inflammatory agent with an anti-histamine agent. Since this combination
`
`is expressly disclosed and thus constitutes a more limited genus, the
`
`additional combinations involving the other seven classes of therapeutic agent
`
`are not relevant per Wrigley. Further, given that both claims 2 and 4 depend
`
`from claim 1, which again discloses the combination of an anti-inflammatory
`
`agent and an antihistamine, and the teachings of the specification reinforce
`
`this linkage, there is no basis in law or logic for why a POSA wouldn't readily
`
`envision a subset of 54 distinct combinations when reading claims 1, 2 and 4.
`
`Schaumann at 316-17 (finding a very limited number of compounds disclosed
`
`9
`
`
`
`when claim 1 of prior art patent was read in conjunction with its
`
`specification).
`
`Segal’s identification of preferred compounds for the topical
`
`anti-inflammatory and therapeutic agents is exactly the type of preference
`
`found in Petering and Wrigley as being sufficient to describe a more limited
`
`genus of compounds and compositions to a POSA. Petering at 681-82;
`
`Wrigley at 1361-62. Under a § 102 anticipation analysis, it is these more
`
`limited genus groups that must be considered. Merck, 874 F.2d at 808.
`
`Because the Decision failed to take into account the expressly taught
`
`preferences in Segal (from both the specification and the claims), it was an
`
`abuse of discretion to not find that Segal discloses a more limited genus of six
`
`preferred anti-inflammatory compounds, and a more limited genus of nine
`
`preferred antihistamine compounds, resulting in 54 total combinations to be
`
`analyzed against the claims at issue.
`
`In sum, given Segal’s disclosure of the combination of an
`
`anti-inflammatory agent and an anti-histamine agent, and its express
`
`identification of a preferred genus of 9 anti-inflammatory agents and 6
`
`anti-histamine agents that encompass the agents at issue in the ’620 patent,
`
`Wrigley, Petering, Schaumann, and Merck all require that these more limited
`
`groups form the starting point for an anticipation analysis under § 102, and
`
`10
`
`
`
`strongly suggest that a POSA would view the six preferred anti-inflammatory
`
`agents with the nine suitable anti-histamines to define a limited and
`
`readily-envisioned class of compositions having 54 members. The
`
`combination of fluticasone propionate and azelastine is undeniably one of
`
`those 54 compositions. Because Segal also enables such a combination as a
`
`nasal composition, for the reasons set forth in the Petition (Pet. 17-18), the
`
`Board should find a reasonable likelihood that claims 1 and 25 will be found
`
`anticipated by Segal.
`
`For the foregoing reasons, Petitioner asks the Board to reconsider its
`
`Decision as to anticipation by Segal, and institute Trial on Ground 1 of the
`
`Petition.
`
`Respectfully submitted,
`
`Dated: September 5, 2017
`
`By: /Michael R. Houston/
`
`Reg. No. 58,486
`
`Counsel for Petitioner
`
`11
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing
`
`PETITIONER’S REQUEST FOR REHEARING PURSUANT TO 37
`
`C.F.R. § 42.71(d) was served on September 5, 2017, on Counsel for Patent
`
`Owner via electronic mail to the following:
`
`dvarughe-PTAB@skgf.com
` dsterlin-PTAB@skgf.com
` alarock-PTAB@skgf.com
` ueverett-PTAB@skgf.com
`
`By: /Michael R. Houston/
`
`
`
`Reg. No. 58,486
`
`Counsel for Petitioner
`
`
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