DETAILED ACTION
The amendment submitted on June 30, 2026 has been entered. Claims 1-7 and 9-17 are pending in the application. Claims 13-17 are withdrawn. Claims 1-7 and 9-12 are rejected for the reasons set forth below. No claim is allowed.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a compound, in the reply filed on June 30, 2026 is acknowledged. Claims 13-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 30, 2026.
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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Improper Markush Grouping
Claims 1-7 and 9-12 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these require-ments in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP1 § 2117.
The Markush grouping of “formula (I)” and “formula (II) is improper because the alterna-tives defined by the Markush grouping do not share both a single structural similarity. The differences in their chemical structure are self evident. More particularly, the compounds of formula (I) are classified in C07J 9/00 (normal steroids containing carbon, hydrogen, halogen or oxygen substituted in position 17 beta by a chain of more than two carbon atoms, e.g., cholane, cholestane, coprostane). On the other hand, the compounds of formula (II) are classified in C07J 63/00 (steroids in which the cyclopenta(a)hydrophenanthrene skeleton has been modified by expansion of only one ring by one or two atoms) or C07J 53/00 (steroids in which the cyclo-penta(a)hydrophenanthrene skeleton has been modified by condensation with a carbocyclic rings or by formation of an additional ring by means of a direct link between two ring carbon atoms).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independ-ent or dependent claims or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. This is a rejection on the merits and is appealable. See MPEP 1200 et seq.
Claim Rejections – 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufac-ture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 9, and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter. Specifically, the claims read on products of nature as evidenced by Kuhajda et al., Eur. J. Drug Metab. Pharmacokinet. 2006;31(3):135-43. See, for example, the chemical structure of ursodeoxycholic acid in Fig. 8 (p. 137). This compound is within the meaning of the first chemical structure recited in claim 12.
Claim Rejections – 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 9, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuhajda et al., Eur. J. Drug Metab. Pharmacokinet. 2006;31(3):135-43.
See, for example, the chemical structure of ursodeoxycholic acid in Fig. 8 (p. 137). This compound is within the meaning of the first chemical structure recited in claim 12.
Claims 1-2 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Macchiarulo2 et al., J. Chem. Inf. Model. 2008;48(9):1792-801.
See the compound referred to as “7αF-Muro-CA (46)” in Table 2 at p. 1794.
Claims 1-2 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5175320 A by Pellicciari3 et al.
See the compound referred to in claim 1 of the reference.
Claims 1-2, 5, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sievänen4 et al., Magn. Reson. Chem. 2008;46:392-97.
See compound 1 in Scheme 1 (p. 393).
Claims 1-2, 5, and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2016/045642 A1 by Li5 et al.
See compound “TUDCA-3,7-F” (p. 31).
Claims 1, 9, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2013/0266656 A1 by Gellman et al.
See compound 1 in Fig. 14.
Claims 1, 9-10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0045808 A1 by Abel-Santos et al.
See, e.g., compound “T10” in Fig. 5.
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 possi-ble 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 accompa-nied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejec-tion 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.
Claims 1-7 and 9-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,072,630 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘630 Patent claims compounds within the scope of the instant claims (see, e.g., claim 7 of the ‘630 Patent). The instant claims are therefore anticipated by the claims of the Patent.
Claims 1-7 and 9-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,939,353 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘353 Patent, of which the present application is a continuation, claims compounds within the instant claims (see, e.g., claim 1 of the ‘353 Patent). The instant claims are therefore anticipated by the claims of this Patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https:// patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
September 16, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
2 Cited in the information disclosure statement (IDS) submitted on February 20, 2024.
3 Also cited in the IDS submitted on February 20, 2024.
4 Also cited in the same IDS.
5 Also cited in the IDS.
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