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
This action is in response to a request for continued examination received May 15th, 2026.
Status of Claims
Claims 1, 4, 30-33, 47, 62-63, and 83-89 are pending in the instant application.
Claims 2-3, 5-29, 34-46, 48-61, and 64-82 have been canceled.
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, 30-32, and 83 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 Claim 47. 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 did not address this rejection in the remarks filed May 15th, 2026. For clarity of the record, the grounds of the rejection are revisited here.
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 instantly recited 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 final rejection mailed February 19th, 2026, 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. Regarding the doses recited instantly at Claim 1 and 47, at Column 203, Lines 50-55, U.S. Patent No. ‘094 teaches oral capsules can include 10-500 mg of the claimed compounds for administration. This range overlaps with the ranges recited instantly at Claim 1 and Claim 47. Per MPEP 2144.05, I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
The rejection of Claims 1 and 83 rejected 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 Claim 47. 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.
Applicant did not address this rejection in the remarks filed May 15th, 2026. For clarity of the record, the grounds of the rejection are revisited here.
As noted in the final rejection mailed February 19th, 2026, 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 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 recited instantly 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, pill, capsule, suspension, or solution. Regarding the doses instantly recited at Claim 1 and Claim 47, at Column 124, Lines 34-36, U.S. Patent No. ‘817 teaches doses are administered in a range from 0.01-5000 mg. This range overlaps with the ranges recited instantly at Claim 1 and Claim 47. Per MPEP 2144.05, I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
The rejection of Claims 1, 30-32 and 83 on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of U.S. Patent No. 12,545,660 is maintained and extended to Claim 47. The examiner notes this was previously raised as a provisional rejection over U.S. Application No. 17/906,582, which has since issued as U.S. Patent No. ‘660. 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.
Applicant did not address this rejection in the remarks filed May 15th, 2026. For clarity of the record, the grounds of the rejection are revisited here.
Claim 8 of U.S. Patent No. ‘660 recites treatment of ulcerative colitis and Crohn’s disease, as recited at Claims 31-32 of the instant application. Further, while U.S. Patent No. ‘660 is drawn to administration of a crystalline form of 4-((4-(1-(tert-butyl)-1H-pyrazol-4-yl)(((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. U.S. Patent No. ‘660 at Column 4, Lines 54-60 teach oral administration is suitable. At Column 20, Lines 65-68, U.S. Patent No. ‘660 teaches oral administration is suitable via tablet administration. Regarding the instantly recited doses at Claims 1 and 47, Column 23, Lines 32-37 teach typical doses are in the range of 0.01-5000 mg. This range overlaps with the ranges recited instantly at Claim 1 and Claim 47. Per MPEP 2144.05, I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
The provisional rejection of Claims 1, 4, and 30-33 on the ground of nonstatutory double patenting as being unpatentable over claim 65-66 and newly presented claims 70-75 of copending Application No. 19/446,296 (reference application) is maintained and extended to instant Claim 47. 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.
In the remarks filed May 15th, 2026, Applicant traverses this rejection on the basis that the reference application is limited to administration of a specific polymorph while the instant claims are not limited to any crystalline form. While the examiner acknowledges this is true, this does not overcome the instant rejection, as administration of a crystalline form of the instantly claimed compound reads on the method instantly recited, for example at Claim 1.
Applicant further traverses this rejection on the basis that the reference application’s claims are silent with respect to the dose and route or form of administration. The examiner does not find this persuasive. With respect to the dose of administration, paragraph [00117] of the reference application teaches a typical dose of 0.01mg-5000mg per day, overlapping with the instantly recited dose. This range overlaps with the ranges recited instantly at Claim 1 and Claim 47. Per MPEP 2144.05, I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
With regard to route of administration, at Paragraph [00104] of the reference application’s specification, it is stated that pharmaceutical compositions may be orally administered and include tablets.
In view of the amended Claims, the reference application is drawn to administration of the same compound as instantly recited, for example, at Claim 1, for the treatment of ulcerative colitis (Claims 65, 72, and 74-75), Crohn’s disease (Claims 66, 71, and 74-75), and IBS-D (Claim 73). Therefore, the instant claims and reference application claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 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, 47, and 83 are rejected.
Claims 62-63 and 84-89 are objected to.
No claim is allowed.
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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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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