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 . Claims 87-107 filed April 22, 2024 are currently pending. Claim 87 and 97 are independent.
Election/Restrictions
Applicant’s election without traverse of Group (II) (claims 97-107) in the reply filed on 01/06/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 87-96 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 01/06/2026.
Priority
Acknowledgement is made of the national stage entry of PCT/US2022/012894 filed 01/19/2022 which claims priority to U.S. Provisional Application 63139112 filed 01/19/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/14/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112-Paragraph B
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 97-100, 102-107 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.
Claim 97 is directed to a compound of Formula (Ia) wherein X2 and X3 form a five-membered ring selected from a pyrrole, a dioxolane, a pyrazole, an imidazole, a triazole, a pyrroline, a tetrahydrofuran, and a thiazole, wherein the five- membered ring is optionally substituted with =0, =S, or an electrophilic moiety if it is a pyrroline, a tetrahydrofuran, or a thiazole; Xi and X2, or X3 and X4, form an imidazole or a triazole; or X2, X3, Y1, Y2, Y3, and Y3 are -OH, with the caveats that
(a) if the pair X2 and X3 together form a dioxolane then optionally Y2 and Y3 form a five- membered ring including one or more heteroatom only if Y2 and Y3 form a pyrroline optionally substituted with a =C, =S, or an electrophilic moiety, and no more than one of Y1, Y2, Y3, Y4 and Y5 is OH, (b) if one or more of Y1, Y2, Y3, Y4 and Y5 is O-CH3, then X2 and X3 form a five- membered ring including one or more heteroatom, wherein the one or more heteroatom is selected from N and S, and the five-membered ring is optionally substituted with a =C, =S, or an electrophilic moiety, and (c) if X3 is OH and one or both of Y3 and Y4 are OH then Y5 is OH.
The metes and bounds of claims are unclear because of the following. The clam recites a conditional “if/then” statement for when X2 and X3 form a dioxalane ring. It is unclear what structural requirements are required for when X2 and X3 form a dioxalane ring and what is excluded from the claim. For example, if X2 and X3 form a dioxalane ring, is it required to have Y2 and Y3 forming a five- membered ring including one or more heteroatom only if Y2 and Y3 form a pyrroline optionally substituted with a =C, =S? An alternative interpretation is that Y2 and Y3 can be any chemical moiety when X2 and X3 are a dioxalane ring as neither Y2 nor Y3 have been defined when X2 and X3 form a dioxalane ring. See compound
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in claim 101, which does not comprise a five membered ring when X2 and X3 are a dioxolane ring.
As recited in MPEP 2173.05 (a) Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." Packard, 751 F.3d at 1311. Applicants need not confine themselves to the terminology used in the prior art, but are required to make clear and precise the terms that are used to define the invention whereby the metes and bounds of the claimed invention can be ascertained. In the instant case, Applicant has failed to do so regarding the claimed genus of Formula (Ia).
For the purposes of examination, the examiner has interpreted that Y2 and Y3 do not have to form a five membered heterocyclic ring is when X2 and X3 together form a dioxalane ring and that Y2 and Y3 can be any chemical moiety when X2 and X3 are a dioxalane ring as neither Y2 nor Y3 have been defined. Subsequent examination is based on this interpretation.
Claims 101 and 105 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.
Claim 101 is directed to a subgenus of compounds embodied within claim 97.
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There is insufficient antecedent basis for the claimed compounds in claim 101 as the claim from which claim 101 depends from (claim 97) does not recite wherein X1, X2 or X3 or X4 is optionally H, or Y1-Y2 and Y5 are optionally H, or wherein Y1 is optionally NO2. Accordingly, one of ordinary skill in the art would not have been reasonably apprised of the metes and bounds of the subject matter for which Applicant was presently seeking protection.
Claim 102 and 106 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.
Claim 102 is directed toa compound of claim 97 wherein the compound comprises an
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There is insufficient antecedent basis for this limitation in claim 102 as the claim from which claim 101 depends from (claim 97) does not recite that the compound of Formula (Ia) comprises an electrophile anywhere on Formula (Ia) as recited by the present claims. Rather, the electrophile in claim 97 is disclosed as optionally present when X2-X3 form a pyrroline, a tetrahydrofuran, or a thiazole (caveat B of claim 97), or optionally appending a pyrrolidine ring when Y2-Y3 form a pyrrolidine and X2-X3 form a dioxalane ring (caveat A of claim 97 ring). Accordingly, one of ordinary skill in the art would not have been reasonably apprised of the metes and bounds of the subject matter for which Applicant was presently seeking protection.
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.
Claim(s) 97, 103-104 and 107 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chung (KR-101292478 published 07/31/2013).
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Chung (KR1292478 published 07/31/2013) teaches PPAR gamma activator compounds of Formula (I). Embraced within said PPAR gamma inhibitor compounds of Formula (I) of An include compounds 57 and 58 which read on the claimed structural limitations: For compound 57: X2 and X3 form a dioxalane ring, no more than one of Y1-Y5 are OH (only Y3 is OH, Y1 and Y5 are each independently H, Y2 and Y4 are each independently alkyl. For compound 58, X2 and X3 form a dioxalane ring, no more than one of Y1-Y5 are OH, Y1-Y2 and Y4-Y5 are each independently H (page 27).
Regarding claim 103, neither compound 57 nor 58 comprise an electrophilic moiety. Regarding claims 104 and 107, An teaches formulating said PPAR gamma inhibitor compounds of Formula (I) with a pharmaceutically acceptable carrier (page 41).
Claim(s) 97, 103, 104 and 107 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cagnoli-Bellavita (Annali di Chimica Vol. 58 pages 823-837 published 1968).
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Cagnoli-Bellavita teach compounds XIII and compound XIV which read on the structural limitations of Formula (Ia) as follows: X1-X2 form an imidazole ring, Y1-Y5 are each independently H (page 827).
Regarding claim 103, neither compounds XIII nor XIV comprise an electrophilic moiety. Regarding claims 104 and 107, An teaches formulating said compounds with a pharmaceutically acceptable carrier of water (pages 832-837).
Conclusion
In view of the rejections set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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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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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621