BICYCLIC CARBOXAMIDES AND METHODS OF USE THEREOF

§103 §DOUBLEPATENT

Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . DETAILED ACTION Claims 14-33 are currently pending in the instant application. Applicants have canceled claims 1-13 and added new claims 14-33 in an amendment filed on August 7, 2025. Claims 14-33 are rejected in this Office Action. I. Priority The instant application is a CON of 18/467,022, filed on September 14, 2023 PAT 12, 215, 093 which is a CON of 17/847, 811, filed on June 23, 2022 PAT 11,795,156 which is a CON 17/070,554, filed on October 14, 2020 PAT 11,472,789 which is a CON of 16/387,294, filed on April 17, 2019 PAT 10,968, 201 which claims benefit of US Provisional Applications 62/746,843, filed on October 17, 2018 and 62/659,068, filed on April 17, 2018. II. Information Disclosure Statement The information disclosure statement (IDS) submitted on March 19, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. III. Rejections Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). Claims 14-33 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,968,201. Although the conflicting claims are not identical, they are not patentably distinct from each other because: Applicants claim PNG media_image1.png 586 742 media_image1.png Greyscale PNG media_image2.png 833 729 media_image2.png Greyscale PNG media_image3.png 472 675 media_image3.png Greyscale . Determining the Scope and Content of the Issued Patent Claim 1 of the issued patent claims PNG media_image4.png 549 299 media_image4.png Greyscale PNG media_image5.png 763 299 media_image5.png Greyscale Issued claim 13 is drawn to species such as PNG media_image6.png 279 300 media_image6.png Greyscale PNG media_image7.png 840 300 media_image7.png Greyscale (see columns 325-337 for the other species). Issued claim 14 is drawn to a pharmaceutical composition comprising these compounds. Ascertaining the Differences Between the Instant Application and the Issued Patent The difference between the issued patent’s claims and the instant application is that the issued patent’s claims are drawn to the compounds of formula I wherein the instant claims are drawn to methods of using the compounds. Finding Prima Facie Obviousness Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-17 of U.S. Patent No. 10,968,201 anticipate the instant claims. Further, patented claims 1-17 explicitly recite compositions corresponding to those of the instant claims. With respect to the conflicting claims being directed to a different statutory class of invention (compositions rather than instantly claimed methods of use), the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer, In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. ` Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010). In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating, [i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)). Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010). Section 804 IIb of the M.P.E.P. states ...those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). In the instant case, the specification of the ‘201 patent identifies the utility for treating EP2 and EP4 mediated diseases or disorders, for example. Since the conflicting patent discloses a utility for the compositions claimed therein which is identical to the method recited in the instant claims, the patented claims anticipate the instantly claimed invention. Claims 14-33 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,472,789. Although the conflicting claims are not identical, they are not patentably distinct from each other because: Applicants claim PNG media_image1.png 586 742 media_image1.png Greyscale PNG media_image2.png 833 729 media_image2.png Greyscale PNG media_image3.png 472 675 media_image3.png Greyscale Determining the Scope and Content of the Issued Patent Claim 1 of the issued patent claims PNG media_image8.png 576 323 media_image8.png Greyscale PNG media_image9.png 786 367 media_image9.png Greyscale Issued claim 13 is drawn to species such as PNG media_image6.png 279 300 media_image6.png Greyscale PNG media_image7.png 840 300 media_image7.png Greyscale (see columns 327-341 for the other species). Issued claim 14 is drawn to a method of treatment using a pharmaceutical composition comprising these compounds. Ascertaining the Differences Between the Instant Application and the Issued Patent The difference between the issued patent’s claims and the instant application is that the issued patent’s claims are drawn method of use for the compound of formula I whereas the instant application also claims “a second therapy”. Finding Prima Facie Obviousness The specie compounds of the instant application is embraced by the genus compound in the patented claims 1-17. The scope of the compounds in the patented claims and the scope of the claims 14-33 of the instant application overlap and have the same utility. For example, the same or obvious species found in issued patent’s claim 13 is found in the instant claim 14. Therefore, one of ordinary skill in the art would be motivated to prepare and claim the scope of the compounds in the issued patent again in the instant application since the scope already patented falls within the full scope of the instant claims 14-33 and both compounds have the same exact activity and utility. As a result, the claims are rejected under obviousness-type double patenting. Claims 14-33 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,795,156. Although the conflicting claims are not identical, they are not patentably distinct from each other because: Applicants claim PNG media_image1.png 586 742 media_image1.png Greyscale PNG media_image2.png 833 729 media_image2.png Greyscale PNG media_image3.png 472 675 media_image3.png Greyscale . Determining the Scope and Content of the Issued Patent Claim 1 of the issued patent claims PNG media_image10.png 541 300 media_image10.png Greyscale (see columns 317-320 for the other species). Issued claim 14 is drawn to a pharmaceutical composition comprising these compounds. Ascertaining the Differences Between the Instant Application and the Issued Patent The difference between the issued patent’s claims and the instant application is that the instant claims are drawn to methods of using the compound of formula I including the species that are claimed in the issued patent’s claims. Finding Prima Facie Obviousness Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-24 of U.S. Patent No. 11,795,156 anticipate the instant claims. Further, patented claims 1-24 explicitly recite compositions corresponding to those of the instant claims. With respect to the conflicting claims being directed to a different statutory class of invention (compositions rather than instantly claimed methods of use), the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer, In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. ` Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010). In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating, [i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)). Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010). Section 804 IIb of the M.P.E.P. states ...those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). In the instant case, the specification of the ‘156 patent identifies the utility for treating EP2 and EP4 mediated diseases or disorders, for example. Since the conflicting patent discloses a utility for the compositions claimed therein which is identical to the method recited in the instant claims, the patented claims anticipate the instantly claimed invention. Claims 14-33 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,215,093. Although the conflicting claims are not identical, they are not patentably distinct from each other because: Applicants claim PNG media_image1.png 586 742 media_image1.png Greyscale PNG media_image2.png 833 729 media_image2.png Greyscale PNG media_image3.png 472 675 media_image3.png Greyscale . Determining the Scope and Content of the Issued Patent Claim 1 of the issued patent claims PNG media_image11.png 450 278 media_image11.png Greyscale (see columns 320-323 for the other species). Ascertaining the Differences Between the Instant Application and the Issued Patent The difference between the issued patent’s claims and the instant application is that the instant claims are drawn to methods of using the compound of formula I including the species that are claimed in the issued patent’s claims. Finding Prima Facie Obviousness Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-24 of U.S. Patent No. 12,215,093 anticipate the instant claims. Further, patented claims 1-24 explicitly recite compositions corresponding to those of the instant claims. With respect to the conflicting claims being directed to a different statutory class of invention (compositions rather than instantly claimed methods of use), the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer, In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. ` Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010). In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating, [i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)). Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010). Section 804 IIb of the M.P.E.P. states ...those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). In the instant case, the specification of the ‘093 patent identifies the utility for treating EP2 and EP4 mediated diseases or disorders, for example. Since the conflicting patent discloses a utility for the compositions claimed therein which is identical to the method recited in the instant claims, the patented claims anticipate the instantly claimed invention. ***the closest prior art is EP 2 277 858 which teaches compounds such as PNG media_image12.png 256 290 media_image12.png Greyscale but does not teach compounds with an indazole group and a spirocyclic ring as seen in the instant compounds (i.e., PNG media_image13.png 161 203 media_image13.png Greyscale ). The method of treatment using the compounds of formula I is neither taught nor suggested by the prior art. IV. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626