DETAILED ACTION
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.
Current Status of 18/037,751
This Office Action is responsive to the amendments and arguments received 20 May 2026.
Claims 1-13, 17-19, 22-23, and 29-30 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I, being claims 1-13 and 17-19 in the reply filed on 15 December 2025 is acknowledged.
Applicant has also elected the following species:
A species of formula V of claim 1, being the compound of claim 17, shown below:
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The elected group and species have been determined to read on claims 1-5, 7, 13, and 17-19.
Claims 6, 8-12, 22-23, and 29-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
A search for Applicant’s elected species did not retrieve applicable prior art or double patent art. Therefore, the search was expanded sufficiently to arrive at the rejections described below. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987).
Priority
Applicant’s claim for the benefit of the prior-filed patent applications PCT/IL2021/051381 (filed 18 November 2021), 63/116,421 (filed 20 November 2020), and 63/186,916 (filed 11 May 2021) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
The Examiner has determined, for the purposes of the instant action, that the effective filing date of the instant claims is 18 November 2021.
Response to Amendments
The objections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments.
The 35 U.S.C. 112 rejections to the claims, present in the previous office action, are partially withdrawn due to Applicant’s amendments.
The 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) rejections to the claims, present in the previous office action, are partially withdrawn due to Applicant’s amendments. New rejections are presented herein, as necessitated by Applicant’s amendments.
Response to Arguments
Applicant argues that the meaning of a C0 alkyl group would be understood by one skilled in the art to clearly indicate a covalent bond. The Examiner disagrees. Applicant is invited to identify a reference that supports their view, such as an excerpt from a textbook or a review paper. Applicants in patent matters may act as their own lexicographer and define C0 alkyl as a bond, but it does not appear that Applicant has done so in the instant specification or claims.
Applicant argues claim 18 was amended to remove the option for R5 to have a “(6- to 10-membered monocyclic or bicyclic aryl)(C0-C3 alkyl)” substituent group; and therefore, claim 18 should not be rejected in view of MOLTENI. To the Examiner, it appears that section b) of the R5 definition in claim 18 still allows for the quoted substituent above.
The Examiner has removed other rejections present in the previous office action, and presents some new rejections herein as necessitated by Applicant’s amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7, 13, and 17-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 18 have each been amended to recite “and if Z is absent RA is directly bound to
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”. This limitation was not previously present, because this allows for the RA group to be attached to any point on the ring shown above. This expands the scope of claim 1 beyond what it was previously, and this was not part of the original disclosure of 18 May 2023. The Examiner determines that the claim amendments discussed immediately above constitute new matter, and this matter was not previously possessed by Applicant.
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.
Claims 1-5, 7, 13, and 17-19 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 1 and 18 each recite the possible presence of a C0 alkyl group. The meaning of a C0 alkyl group is unclear, and this renders claims 1-5, 7, 13, and 17-19 indefinite. Applicant may choose to amend the claims to remove any references to C0 alkyl groups.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
STN (STN CAS REGISTRY, CAS Registry Number 2324899-18-3, Entered Database 6 June 2019).
STN teaches that the compound shown below was publicly available as of 6 June 2019. This compound falls within the genus of instant claim 1. Defining the variables of Formula V, of instant claim 1, as follows produces the compound of STN: Z and RA are absent; A is N-R; R is a phenyl ring; r is 1; R6 is a methyl group in the para position; n and o are equal to 0; t is equal to 1; p is equal to 0; and R5 is a phenyl ring.
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Regarding claim 4: Instant claim 4 appears to narrow the definition of the RA group of Formula VIb of claim 2, but does not require a compound of Formula VIb to be chosen from claim 2.
Claims 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
MOLTENI (WO 2007/092065 A1, International Publication Date 16 August 2007).
MOLTENI generally teaches compounds and pharmaceutical compositions thereof for the treatment of diseases associated with liver X receptors (abstract). MOLTENI teaches compound 60, shown below, on page 32 therein. This compound falls within the genus of instant claim 1. Defining the variables of Formula V, of instant claim 1, as follows produces compound 60 of MOLTENI: Z and RA are absent; A is N-R; R is a phenyl group, wherein R6 is a C1-alkyl group and r is 1; n and o are equal to 0; t is equal to 1; p is equal to 1; R5 is a 6-membered monocyclic, aliphatic ring having one N atom therein; the R5 group is substituted by two X groups, which are both 6-membered monocyclic aryl rings; each of the X groups is substituted by one Y group; and both Y groups are alkoxy groups.
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Claim 6 of MOLTENI teaches pharmaceutical compositions of the compounds therein, which are made up of a therapeutically effective amount of a compound and a pharmaceutically acceptable excipient.
Regarding claim 19: Paragraph [0095] of MOLTENI discusses an in vitro assay containing Tris buffer and one of the compounds claimed therein at a concentration of 5 µM within an assay well. This solution reads on the pharmaceutical composition claimed within instant claim 19.
Conclusion
No claims are currently allowable.
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 JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
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, ANDREW D KOSAR can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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