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
Instant application 17/771,718 filed on 04/25/2022 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1, 8-13, 15-16, 19, 24, 29, 30, 31, 33, 35-36, 38 and 40-41 are pending.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/12/2026 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/21/2023 were compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments/Amendments
The amendment filled on 12/03/2025 has been entered.
Regarding 102 rejections, Applicant’s amendment has overcome all 102 rejections of record. Thus, the 102 rejection of record is withdrawn.
However, the search was expended to additional species. New 102 rejection is made below.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to compounds, in the reply filed on 05/05/2025 is acknowledged.
Claims 36, 38, 40 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/05/2025.
Regarding species election Applicant’s election without traverse of
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Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Species Election
A careful review of the prior art has indicated that elected species is free of the prior art. A claim directed to the elected species in independent form would be free of the prior art.
The examiner has moved onto alternative species embodied within the general formula recited in the instant claim 1. The search was expanded to the following additional species:
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and
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Claims 10, 24 and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonexpanded species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/05/2025.
Claims 1, 8, 9, 11-13, 15, 16, 19, 29, 31, 33 and 35 are under current consideration.
Claim Rejections - 35 USC § 102
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.
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, 8, 9, 11, 13, 15, 16, 19 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilpart (M. Wilpart, P. Mainguet, A. Maskens, M. Roberfroid, Structure-activity relationship amongst biliary acids showing co-mutagenic activity towards 1,2-dimethylhydrazine, Carcinogenesis, Volume 4, Issue 10, October 1983, Pages 1239–1241) evidenced by CAS Registry Number RN 2276-93-9 (entered to STN 16 Nov 1984).
Wilpart teaches biliary acids (see title and Fig 1).
Wilpart teaches alloisolithocholic acid (see the last compound Fig. 1.):
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As evidenced by RN 2276-93-9 alloisolithocholic acid is also known as isoallolithocholic or 3β-hydroxy-5α-cholanic acid:
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The above compound (3β-hydroxy-5α-cholanic acid) falls under the instant formula (I):
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wherein R1 is hydrogen, R2 is C1 alkyl, R3 is methyl, R4 is hydrogen, R5 is hydrogen, R6 is hydrogen, R7 is hydrogen, X is COOH, n is 2, the bond between 4,5 position is a single bond, and the bond between 5,6 position is a single bond.
Regarding instant claim 30, it should be noted that 3β-hydroxy-5α-cholanic acid falls under instant formula (II):
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wherein R1 is hydrogen, R2 is C1 alkyl, R3 is methyl, R4 is hydrogen, R5 is hydrogen, R6 is hydrogen, R7 is hydrogen, X is COOH, n is 2.
Since 3β-hydroxy-5α-cholanic acid (RN 2276-93-9) meets all limitations of instant claims 1, 8, 9, 11, 13, 15, 16, 19 and 29, those claims are anticipated.
Claims 1, 8, 9, 12, 13, 15, 16 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN, CAS registry Number 111900-81-3 (CAS registry Number 111900-81-3, entered to STN 18 Dec 1987).
This rejection applies to expanded species.
STN, CAS registry Number 111900-81-3 teaches:
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The above compound (111900-81-3) falls under the instant formula (I)
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wherein R1 is hydrogen, R2 is C1 alkyl, R3 is methyl, R4 is hydrogen, R5 is hydrogen, R6 is hydrogen, R7 is hydrogen, X is COOH, n is 2, the bond between 4,5 position is a single bond, and the bond between 5,6 position is a double bond.
MPEP 2128 states that “Electronic publications on the internet or on an online database are considered to be publicly available as of the date the item was publicly posted”.
In the instant case the above compound (RN: 111900-81-3) has been entered to STN on September 14, 2007.
Since the RN 111900-81-3 meets all limitations of instant claims 1, 8, 9, 12, 13, 15, 16 and 19, those claims are anticipated.
Conclusion
Claims 1, 8, 9, 11-13, 15, 16, 19 and 29 are rejected.
Claims 10, 24, 30, 36, 38, 40 and 41 are withdrawn
Claims 31, 33 and 35 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S./ Examiner, Art Unit 1621
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621