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 .
DETAILED ACTION Status of 18/844,421
Claims 1-22 are currently pending.
Priority
Instant application 18/844,421, filed 9/6/2024, claims priority as follows:
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Support for the instant claims is found in the provisional application.
Information Disclosure Statement
All references from the IDS’s submitted on 1/2/2025 and 2/4/2026 have been considered unless marked with a strikethrough.
Objection to the Abstract
The abstract of the disclosure is objected to for insufficient length, as it is less than 50 words. The abstract should generally be within the range of 50 to 150 words in length, and chemical abstracts in particular should provide the structure of the compound of a formula thereof in addition to methods of use. See MPEP § 608.01. Appropriate correction is required.
Election/Restriction
Applicant’s election of Group I, claims 1-19, drawn to compounds of Formula I and compositions thereof, in the reply filed 8/31/2026 is acknowledged. Applicant’s election of the compound of the following formula:
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In the same reply, is also 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)).
Examination will begin with the elected species. In accordance with 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 examined again. 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 further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and no prior art was identified. Thus, the search was expanded to compounds of instant Formula I where R1 is phenyl substituted with one R5, where R5 is halo, R2 is -SRa, where Ra is C1 alkyl, R3 is cyano, and X, Y, and Z are all CR4, where R4 is hydrogen. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1-8, 10-14, and 19 read on the expanded species. Claims 9, 15-18, and 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112(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 1-8, 10-14, and 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.
Claim 1 recites the limitation, “Rf”, in the functional groups -NRfC(O)RdRe, -NRfC(S)NRdRe, -NRfS(O)2NRdRe of the variable R6. The variable is not defined in claim 1 nor the entire instant disclosure, and thus is indefinite and unclear. Dependent claims 2-8, 10-14, and 19 do not resolve this issue by defining the variable and are also rejected. Appropriate correction is required.
Claim Rejections – Improper Markush
Claims 1-8, 10-14, and 19 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
With respect to claim 1, the Markush groupings of Formula I are improper because the alternatives defined by the Markush groupings do not share both a single structural similarity and a common use for the following reasons: The Markush groups R1, X, Y, and Z of Formula I contain variables that can be independently selected from various monocyclic and polycyclic saturated and unsaturated carbon and hetero-based rings, and various core atoms substituted with numerous functional groups . From this definition, the variables R1, X, Y, and Z share no common core. In fact, many interpretations of the variable R1 can constitute a great portion of the structure that is more significant than the X, Y, and Z core in both structural volume and molecular weight. A skilled artisan would recognize the variation in ring size, atom selection, and functional group installation can lead to variations in biological and chemical properties such as bond angles and binding pose of the substrate in the target. They do not belong to the same recognized physical or chemical class or to the same art-recognized class.
The instant specification discloses compounds that have the property of PPARG inverse agonism. The scope of the compounds tested compared to the instant claims is small; the are no examples of compounds where R1 is a heterocyclyl, and no examples of compounds where X and Z are N. In fact, there are no examples of compounds where R4 is any other variable than hydrogen. No other data supporting varying rings or atom substitution of the common core is disclosed and therefore no structure-function relationship between the varying ring sizes or atom substitution is corroborated. In this case, the claims are so expansive that a common utility cannot be expected. Dependent claims 2-8, 10-14, and 19 do not resolve the issue by defining all of the variables and are therefore also rejected.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claims 1-8, 10-14, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jorgensen (Jorgensen, W. L. et. al. Bioorg. Med. Chem. Lett. 2011, 21, 4545-4549., cited in the IDS of 1/2/2025). This rejection applies to the expanded species.
The reference Jorgensen is drawn to substituted N-phenylbenzisothiazolones (abstract), and specifically discloses compound 16 (page 4547, Scheme 1):
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Where R1 is CN. The reaction to generate compound 16 is run in DMSO, which when the product is formed constitutes a pharmaceutical composition. Compound 16 anticipates a compound of instant Formula I:
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When R1 is phenyl substituted with one R5, where R5 is halo, R2 is -SRa, where Ra is C1 alkyl, R3 is cyano, and X, Y, and Z are all CR4, where R4 is hydrogen. Thus, Jorgensen anticipates claims 1-8, 10-14, and 19.
Conclusion
Claims 1-8, 10-14, and 19 are rejected. Claims 9, 15-18, and 20-22 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton 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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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
