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
Response to Amendment
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/13/2026 has been entered.
Claims 21-40 and 42-44 are pending in the application. Claims 21-40 and 42 are withdrawn and Claims 43-44 are examined herein.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Response to Applicant’s Arguments
Applicant again argues that Yu provides no specific motivation to select a hydroxy substituent at the C11 position. Applicant further argues Yu does not provide motivation to select a specific configuration of the hydroxyl group suggested by Yu. Applicant argues the stereoisomer is not prima facie obvious because Compound 100 is unexpectedly selective for FXR modulators (Spec: Page 1). Compound 100 is a hydrogenated form of the claimed intermediate, rather than the compound itself. Applicant argues that it is unexpected that such an intermediate can be used to form a potent, selective FXR modulator and that number, position, and orientation of hydroxyl groups affects properties significantly. It is known in the art that the addition of a beta hydroxyl at C11 of bile acid derivatives yields selective FXR agonist. Applicant corroborates this, citing US Patent No. 9611289. Further, Pellicciari (WO2014184271) teaches the selection of a beta hydroxy group at the C11 position of bile acid derivatives yields selective FXR agonists (Page 32, Lines 4-5 and Table 1; Figure 1). Applicant’s arguments are fully considered and persuasive because Yu teaches TGR5 modulators, whereas the products formed from the claimed intermediates are selective for FXR and have no activity against TGR5 (Pellicciari: Page 32, Table 1). Therefore, the rejection issued over Yu is withdrawn in view of applicant’s amendments. A new rejection over 35 USC 103 is issued below.
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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Forman (Steroids 77 (2012) 1335–1338) in view of Pellicciari (WO2014184271, 9/5/2023 IDS).
Forman teaches methods of synthesizing a potent selective FXR agonist as follows (Abstract; Page 1336, Fig. 2):
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.
Intermediate 3 differs from the claimed intermediate in that Int 3 lacks a C11 beta hydroxy group.
Forman does not suggest the addition of a beta hydroxy at the C11 position before or after the synthesis of Int 3.
Pellicciari teaches Compound 100,
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, which differs from Compound 4, the product of Forman, by the addition of a beta hydroxy at the C11 position (Page 30). Pellicciari teaches the particular addition of the beta hydroxy group yields a potent, and selective FXR agonist, the same result desired in Forman (Page 32, Table 1). Pellicciari specifically compares Compound 100 to Forman Compound 4/Obeticholic Acid/INT-747/Pellicciari Compound A, noting increased potency (Figure 1):
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One of ordinary skill in the art seeking to form a potent, selective FXR modulator as described by both Forman and Pellicciari, would find it obvious to modify the Forman synthesis through the addition of the beta hydroxy at the C11 to any of the intermediates or starting material of Fig. 2. Such a modification would yield applicant’s elected species as an intermediate when forming the selective, potent FXR agonist. One would expect success in forming the intermediate for the synthesis of the potent end product of Pellicciari before the effective filing date of the instant application because the synthetic route deployed in Forman only serves to add an ethyl group to C6 and hydrogenate the oxo group at C7, leaving the hydroxy groups in tact or preserved by a protecting group.
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.
PROVISIONAL:
Claims 43-44 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1, 4-5, 10-20, 24-25 of copending Application No. 18878533 (hereinafter referred to as intercept).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a genus of bile acid derivatives.
Intercept teaches methods which require the compounds of the instant claims.
Formula (B) of intercept
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and the elected species
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differ in that the elected species possesses an oxo substituent at C7. Intercept teaches the hydroxy and hydrogen at C7 may instead be a single oxo.
One of skill in the art, in view of Intercept teaching oxo as an alternative embodiment to OH and H, would find it obvious to modify formula (B) accordingly and expect the resulting compound, within the scope of formula (I), to treat cognitive impairment as taught by Intercept.
Since both applications teach bile acid derivatives, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Intercept.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 7:30am - 4:30pm.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627