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 .
Status of Claims
Claims 1, 4, 30-33, 45, 47, 62-63, and 83-89 are pending in the instant application.
Claims 2-3, 5-29, 34-44, 46, 48-61, and 64-82 have been canceled.
Withdrawn Objections/Rejections
Applicant’s amendment is sufficient to overcome the objections to the specification. These objections are hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection of Claims 1-2, 4, 29-40, 45, 47, 50, and 62-63 under 35 U.S.C. 112(a). Claims 2, 29, 34-40, and 50 have been canceled, rendering the rejection thereof moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claim 65 renders the rejection thereof under 35 U.S.C. 112(b) moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claim 65 renders the rejection thereof under 35 U.S.C. 101 moot. This rejection is hereby withdrawn
Applicant’s statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, no later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were commonly owned is sufficient to overcome the rejection of Claims 1-2, 29-40, 50, and 62-63 under 35 U.S.C. 102(a)(2). Applicant’s cancellation of Claims 2, 34-40, and 50 renders the rejection thereof moot. This rejection is hereby withdrawn.
Accordingly, Applicant’s statement pursuant to 35 U.S.C. 102(b)(2)(C) is sufficient to overcome the rejection of Claims 45 and 47 under 35 U.S.C. 103. This rejection is hereby withdrawn.
Applicant’s cancellation of Claims 2 and 29 renders the rejections thereof on the ground of nonstatutory double patenting moot. These rejections are hereby withdrawn.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
The rejection of Claims 1, 4, and 30-32 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13-15, and 19 of U.S. Patent No. 11,773,094 is maintained and extended to newly presented Claim 83. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to the administration of 4-((4-(1-(tert-butyl)-1H-pyrazol-4-yl)(((4-(4-methoxy-3-methylphenyl)bicyclo[2.2.2]octan-1-yl)methyl)carbamoyl)cyclohexyl 3-hydroxyazetidine-trans-1-carboxylate for an overlapping set of liver and/or gastrointestinal diseases.
Applicant has traversed this rejection on the basis that the amendment incorporating the limitations previously recited at Claim 50 renders the grounds of nonstatutory double patenting moot.
The examiner does not find this argument persuasive.
Claim 1 has been amended to recite specific diseases or conditions and with an additional limitation of oral administration in the form of an oral solution, oral suspension, powder, pill, tablet or capsule.
As noted in the previous office action, Claim 14 of U.S. Patent No. ‘094 recites a method of treating primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), nonalcoholic steatohepatitis (NASH), nonalcoholic fatty liver disease (NAFLD), or Alagille syndrome, all of which are recited instantly at Claim 1, in a mammal comprising administering a compound according to the formula:
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Further, at Claim 19, U.S. Patent No. ‘094 teaches the method of Claim 14 includes administration of the compound:
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As noted in the previous office action, this compound is the compound as instantly recited, for example, at instant Claim 1.
Regarding Claims 30-32, Claim 15 of U.S. Patent No. ‘094 is drawn to treatment of inflammatory bowel disease, ulcerative colitis, and Crohn’s disease, as instantly recited at Claims 30-32.
The claims of U.S. Patent ‘094 are silent with respect to the mode of administration of the aforementioned compound. At Column 11, Lines 18-28, however, U.S. Patent No. ‘094 teaches that the pharmaceutical compositions to which the claims are drawn can be formulated for administration by oral administration in the form of a tablet, pill, capsule, liquid, a suspension, a gel, a dispersion, a solution, and an emulsion. Therefore, the broadest reasonable interpretation of the method to which Claims 1, 13-15, and 19 of U.S. Patent No. ‘094 are drawn would include oral administration in the form of oral solution, oral suspension, or pill, as instantly recited at Claim 1. Therefore, the rejection is extended to newly presented claim 83.
The rejection of Claim 1 on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,084,817 is maintained and extended to newly presented claim 83. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are directed toward a method of treating a liver disease or condition comprising administration of the same compound.
As above, Applicant has traversed this rejection on the basis that the amendment incorporating the limitations previously recited at Claim 50 renders the grounds of nonstatutory double patenting moot.
The examiner does not find this argument persuasive.
As noted in the previous office action, Claim 15 of U.S. Patent No. ‘817 is directed toward a method of treating a liver disease or condition comprising administration of a compound of Claim 1, as recited in the patent. This includes the same compound as recited in instant Claim 1, as Claim 2 of U.S. Patent No. ‘817 recites the following compound:
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.
As noted previously, this is the compound recited instantly at Claim 1.
Claim 15 of U.S. Patent No. ‘817 is silent with respect to the specific diseases or conditions or mode of administration. Regarding the conditions, at Column 12, second paragraph, U.S. Patent No. ‘817 teaches the instantly claimed method is suitable for treating PBC, PSC, NASH, and NAFLD, each of which are instantly recited at Claim 1. Regarding the modes of administration, at Column 11, Lines 10-17, U.S. Patent No. ‘817 teaches suitable modes of administration include oral administration, including a tablet, a pill, a capsule, a suspension, or solution. Therefore, practice of instant Claim 1 reads on Claim 15 of U.S. Patent No. ‘817.
The provisional rejection of Claims 30-32 on the ground of nonstatutory double patenting as being unpatentable over claims 65-66 of copending Application No. 17/906,582 (reference application) is maintained and extended to newly presented claim 83. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the administration of a common compound for treating an overlapping set of diseases and/or conditions.
As above, Applicant has traversed this rejection on the basis that the amendment incorporating the limitations previously recited at Claim 50 renders the grounds of nonstatutory double patenting moot.
The examiner does not find this argument persuasive.
Claim 66 of the reference application recites treatment of ulcerative colitis and Crohn’s disease, as recited at Claims 31-32 of the instant application. Further, while the reference application is drawn to administration of a crystalline form of 4-((4-(1-(tert-butyl)-1H-pyrazol-4-yl)(((4-(4-methoxy-3-methylphenyl)bicyclo[2.2.2]octan-1-yl)methyl)carbamoyl)cyclohexyl 3-hydroxyazetidine-trans-1-carboxylate. Administration of a crystalline form of this compound reads on the limitations recited instantly at Claims 30-32. The reference application’s claims are silent with respect to the route of administration. At Page 25, Paragraph 102, the reference application teaches administration is suitable for oral administration, and at Paragraph 103, compositions suitable for oral administration include capsules, tablets, powder, solution, or suspensions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, and 30-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-51 and 65-67 of copending Application No. 19/446,296 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the administration of a common compound for treating an overlapping set of diseases and/or conditions. This is a new rejection not previously raised in the non-final rejection mailed July 24th, 2025, as the reference application was filed on a later date.
The reference application differs from the instant application in that the reference application specifies administration of a crystalline form of 4-((4-(1-(tert-butyl)-1H-pyrazol-4-yl)(((4-(4-methoxy-3-methylphenyl)bicyclo[2.2.2]octan-1-yl)methyl)carbamoyl)cyclohexyl 3-hydroxyazetidine-trans-1-carboxylate. Administration of a crystalline form compound reads on the limitations instantly recited. Further, substantial overlap exists in the recitation of the diseases and/or conditions suitable for treatment. The reference application is drawn to the treatment of NASH or NAFLD (Claims 48 and 50-51), cirrhosis (Claim 49), ulcerative colitis (Claim 66), Crohn’s disease (Claim 66), IBS-D (Claim 67). Instantly, these diseases and conditions are recited throughout the aforementioned claims. While the reference application’s claims are silent to the route of administration as instantly claimed, at Paragraph 102 of the specification of the reference application, it is taught oral administration is a suitable delivery method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 45, 47, 62-63, and 84-89 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1, 4, 30-33, and 83 are rejected.
Claims 45, 47, 62-63, and 84-89 are objected.
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624