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 .
Response to Arguments
Applicant’s arguments, see pp. 6-8, filed 04/10/2026, with respect to the objection to claims 1 and 7; the rejection of claims 1-2, 7 and 12 under 35 U.S.C. 112(a); the rejection of claims 1-2, 7 and 12 under 35 U.S.C. 112(b); and the rejection of claims 1-2, 7 and 12 under 35 U.S.C.102(a)(1) have been fully considered and are persuasive.
Amendments overcome the objections to claim 1 and 7 and applicant’s arguments with respect to the naming of compounds are persuasive with respect to the objection to claim 7.
Amendments moot the rejections.
The objections/rejections of 01/20/2026 have been withdrawn.
Note the claims have only been searched to the extent necessary to find additional prior art reading on the claims pursuant to the election of species requirement of record.
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, 7 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAPlus Registry Number: RN 1047082-77-8. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 1047082-77-8, Entered STN: 07 Sep 2008].
RN 1047082-77-8:
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605
623
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is a compound of general formula (I) of claim 1 wherein a is a single bond; R1 is hydrogen and R2 is hydroxyl; R3 is methyl; and R4 is hydrogen. It is also the compound 3α-hydroxy-5α-cholan-6-one recited in claim 7.
With respect to claim 12, solubility data in water is reported:
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529
653
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which suggests the compound in water which is a pharmaceutically acceptable excipient of claim 12. Accordingly, claims 1-2, 7 and 12 are anticipated by RN 1047082-77-8.
Registry number RN 1047082-77-8 is available as prior art as of 07 Sep 2008, the day it was indexed into the CAplus database.
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compounds anticipate the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 states the following:
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181
880
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Conclusion
Claims 1-2, 7 and 12 are rejected.
Claims 3-6 and 8-11 are withdrawn.
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 JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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, 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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/JED A KUCHARCZK/ Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/ Primary Examiner, Art Unit 1621
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