DETAILED ACTION
Claims 25-28 and 30-31 are currently pending in the instant application.
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 .
Priority
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Information Disclosure Statement
Applicant's Information Disclosure Statement filed on 06/05/2008 has been considered. Please refer to Applicant's copies of the 1449 submitted herewith.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 26, 30 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 26 and 31 recite “derivative that can act as an acylating agent”. The specification fails to limit and clearly delineate what can be considered a "derivative." According to Hackh's chemical dictionary, "derivative" is defined as a compound, usually organic obtained from another compound by a simple chemical process or an organic compound containing a structural radical similar to that from which it is derived (Hackh's chemical dictionary, 1972). It is unclear how the carboxylic acid or ester group can be converted to “derivative that can act as an acylating agent”. Multiple derivatives having various functional groups and chemical reactivity are encompassed by this limitation and said “derivatives that can act as an acylating agent” are not defined by a structural formula so as to reasonably apprise a skilled artisan of the metes and bounds of the claims. Such language fails to clearly define the subject matter being claimed. Thus the term "derivative that can act as an acylating agent" of claims 26 and 31 are not defined in the claims so as to know the metes and bounds of the claims. Since claim 30 depends on claim 26 and does not fix the issue, claim 30 has also been rejected.
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.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,384,116 (hereafter referred to as ‘116). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘116 discloses a method of converting a compound of formula
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to ursodeoxycholic acid or a carboxylate salt at the 24-position thereof which comprises the same steps as instant claim 25. Although instant claim 25 recites additional compounds, those of formula III, IIIa or IIIb that may be converted into ursodeoxycholic acid or a carboxylate salt at the 24-position thereof, ‘116 still reads on instant claim 25.
Allowable Subject Matter
Claims 27-28 are allowed.
Compounds of Formula I, Ia, III, and IIIb were previously allowed in U.S. Pat. No, 11,384,116. Thus, methods of using said compounds would also be considered allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. CN 112375117 (cited in IDS filed 07/18/2022) teaches methods of synthesizing similar compounds that proceed through
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rather than intermediates having the carboxylate chain as shown
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found in the instant application.
FANTIN (see Steroids, 1993, Vol. 58, p. 524-526, cited in IDS filed 07/18/2022) teaches compounds of Formula III wherein R1 is H transformed
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(Y is H2, X = O) – compound 2b corresponds to a compound of Formula III
into compound of formula
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or
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rather than ursodeoxycholic acid, tauroursodeoxycholic acid, obeticholic acid or 7-ketolithochoic acid.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623