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 election received 15 December 2025.
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Claims 6, 8-12, 22-23, and 29-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Information Disclosure Statement
The information disclosure statements (IDS) received on 5 July 2024 and 15 December 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, these information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1 and 18 are objected to because of the following informalities: The phrase “each of which R9 may be optionally substituted” in section “c)” is grammatically incorrect. Applicant may replace the quoted phrase above with “wherein each R9 may be optionally substituted”. Appropriate correction is required.
Claims 1 and 18 are objected to because of the following informalities: The definition of “Y”, within section “b)”, is selected from “… sulfoxide, sulfonylamino, or thiol”. The word “or” within each use of that phrase should be replaced with the word “and”. Appropriate correction is required.
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.
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 A being equivalent to a CH group. This would result in an unstable structure, so it is unclear to the reader if the claim is intended to recite CH or CH2. This renders claims 1-5, 7, 13, and 17-19 indefinite. Applicant may choose to amend the claims to recite “CH2”, with proper support.
Claims 1 and 18 each recite, within the definition of “A”, that R is “[omitted structure 1] and [omitted structure 2]”. It is unclear how R could simultaneously be 2 dissimilar structures. This renders claims 1-5, 7, 13, and 17-19 indefinite. Applicant may choose to amend the claims to replace the word “and”, within the quoted phrase above, with “or”.
Claims 1 and 18 each recite RA and Z as being absent or present. It is not clear what the structure of the claimed compound would be if Z was absent and RA was present, as it is not clear if or how the RA would be attached to the parent structure. It is also not clear what the structure of the claimed compound would be if Z was present and RA was absent, due to the unstable structures formed in that situation. This renders claims 1-5, 7, 13, and 17-19 indefinite. Applicant may choose to amend the claims to explain what would happen to the other group of the pair discussed above if one of them were absent, with proper support.
Claims 1, 7, 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.
Claims 1 and 18 each recite some Rz groups that have “z” present as a superscript character, while others do not. This causes it to be unclear to the reader whether or not these are referring to two different groups. This renders claims 1-5, 7, 13, and 17-19 indefinite. Applicant may choose to amend all of these groups to recite “Rz”, with proper support.
Claims 1 and 18 each recite two dissimilar definitions of X. This causes confusion as to the true definition of X, and renders claims 1-5, 7, 13, and 17-19 indefinite. Applicant may choose to delete the definition of X within section “b)” or outside of section “b)” in these claims.
Claims 1 and 18 each recite that “each X, R1, R2, R3, R6, and R7 represents one or more substituents, each substituent is independently selected from”. This causes these groups to have at least unclear attachment points. For example, If R1 was equivalent to three chloro groups, it is not clear where they would be attached to the structure of Formula V. This renders claims 1-5, 7, 13, and 17-19 indefinite. Applicant may choose to delete the following portion of the quoted phrase above “represents one or more substituents, each substituent”.
Claims 1 and 18 each recite, at the bottom of the section that begins with “each X, R1, R2, R3, R6, and R7”, “wherein two or more substituents are interconnected to form a fused aromatic ring”. This fused substituent section is unclear for the following reasons: it is unclear if this refers to X, R1, R2, R3, R6, R7, or Y groups, and/or mixtures thereof; it is not clear how some substituents, such as two halo groups, could form a ring; and it is not clear if the substituents are forming a fused ring with the parent ring, with each other, or either of these. This renders claims 1-5, 7, 13, and 17-19 indefinite. Applicant may choose to delete the entire fused substituent section at the end of the indicated paragraph.
Claims 1 and 18 each recite two dissimilar definitions of Y. This causes confusion as to the true definition of Y, and renders claims 1-5, 7, 13, and 17-19 indefinite. Applicant may choose to delete the definition of Y within section “b)” or outside of section “b)” in these claims.
Claim 1 recites a single “R5” group at the bottom of the claim. This causes it to be unclear to the reader whether this “R5” group refers to a different group compared to the R5 group above in the claim. This renders claims 1-5, 7, 13, and 17-19 indefinite. Applicant may choose to amend all of the “R5” group to recite “R5”, with proper support.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 7, and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 shows, within Formula VIb, the group identified within claim 1 as “A” as being a CH2 group. As currently written, claim 1 does not allow for group A therein to be equivalent to a CH2 group. See the related 35 USC 112(b) rejection above.
Claim 7 recites variables R10 and R11, which are not present within claim 1, upon which this claim depends. These additional variables do not further limit the subject matter of claim 1, and instead attempt to expand the scope of claim 1. Applicant may choose to amend this claim to remove variables R10 and R11.
Claim 17 recites “wherein the compound comprises:”. The term “comprises” attempts to expand the scope of claim 17 beyond the parent claim, claim 1. Claim 1 only recites a compound or a pharmaceutically acceptable salt thereof. Applicant may choose to replace the quoted phrase above with “wherein the compound is:”.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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 and 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).
Regarding claims 1-3 and 5: 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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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. Therefore, the compound of MOLTENI still anticipates this claim.
Regarding claim 18: 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.
Claims 1-3 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
STN (STN CAS REGISTRY, CAS Registry Number 1387557-44-9, Entered Database 7 August 2012).
Regarding claims 1-2 and 13: STN teaches that the compound shown below was publicly available as of 7 August 2012. 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 CH2; n and o are equal to 0; t is equal to 1; p is equal to 0; and R5 is -NH(C=W)NH2, wherein W is equal to S.
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Regarding claim 3: Instant claim 3 appears to narrow the definition of “r” from the parent claim 1, but does not require an “r” to be present. Therefore, the compound of STN still anticipates this claim.
Conclusion
No claims are currently allowable.
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.
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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