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 .
Status of Claims
Claims 1-22 are pending in the instant application.
Information Disclosure Statement (IDS)
The Information Disclosure Statements filed 08/14/2023 and 08/14/2025 were considered by the Examiner.
Response to Restriction/Election Requirement
Applicant’s election with traverse of the following compound,
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, to prosecute Group I, in the reply filed on November 3rd, 2025, is acknowledged. The transversal is on the grounds that examination of all of the claims does not create an undue search burden on the examiner. This is not found persuasive in view of the art below.
Applicant states that Claims 1-9 and 11-21 encompass the elected species. However, claims 4, 5 and 10 do not read on the elected species. Regarding claims 4-5, in the elected species Z is -C(O)- and X is -NH, these claims do not allow for this. Further, regarding claim 10, in the elected species R2 is H and R1 is C(O)R3, wherein R3 is heterocycloalkyl, substituted with R4, wherein R4 is aryl, claim 10 does not allow for this. As such, claims 4-5 and 10 are also withdrawn as being drawn to a nonelected species.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species is not allowable. Therefore, according to MPEP 803.02:
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability.
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush claim and claims to the elected species will be rejected, and claims to the nonelected species will be held withdrawn from further consideration.
As the elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 1-3,6-9 and 11-21 have been examined to the extent that they are readable on the elected compound above. Since the elected species is not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration, claims 4-5, 10 and 22 is withdrawn as being drawn to a nonelected group. Any additional issues below that address subject matter outside the scope of the search and examination discussed above are presented in the interest of compact prosecution since they were discovered incidental to said search and examination.
Improper Markush Grouping
Claims 1-3, 6-9, 11 and 16-21 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.
The Markush grouping of Formula (A) is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the various permutations of variables X, Y and Z and rings A and B result in compounds that only require a structure of a tricyclic structure in common, which is not a significant structural similarity. The varying permutations are not recognized to belong to the same physical or chemical class or to the same art-recognized class. 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. The scope of formula A (inclusive of the elected species) that would form a proper Markush grouping would be where X is -C(O) and X and Y are -NH. There would appear to be several different ways in which a proper Markush grouping could be derived from the scope instantly claimed; however, defining the X, Y and Z variables would appear to be a minimum requirement since the options for X, Y and Z to be the multiple options listed in instant claim 1 results in numerous dissimilar ring permutations.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 6-9 and 11-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schinazi et al (WO 2019/213584 A1, as cited on the IDS dated 08/14/2023).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Schinazi teaches a method for treatment or prophylaxis of a disease affected by Retinoic Acid Receptor-like Orphan Receptor (ROR) modulators, comprising administering an effective treatment amount of a pharmaceutical composition comprising a compound of any of a general formula (A) to a patient in need of treatment thereof (claim 27).
Schinazi further teaches that the disease is ischemic stroke (claim 29).
Schinazi teaches compounds of formula (A) that includes the following (claim 13):
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This compound is embraced by instant formula A, wherein Z is -C(O)-, X is -NH-, Y is -NH, A and B are phenyl, R2 is H, and R1 is C(O)R3, wherein R3 is heterocycloalkyl, substituted with R4, wherein R4 is aryl.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Schinazi does not teach an explicit embodiment where the compound above was administered to a patient.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding claim 1, while the prior art does not explicitly teach an embodiment where the compound above was administered to a patient, Schinazi teaches compounds of instantly claimed formula B and their utility in treating a subject suffering from ischemic stroke. A person having ordinary skill in the art would have been motivated to screen the example compounds of the prior art in the particular utilities to determine which would provide optimum treatment outcomes.
Regarding claim 2, Schinazi teaches that the compound is an ROR alpha agonist (claim 36).
Regarding claims 3 and 6, X is -C(O) and Z is -NH-.
Regarding claim 7, Y is -NH.
Regarding claims 8-9, R2 is H.
Regarding claim 11, R2 is
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Regarding claim 12, R2 is -C(O)-heterocyclyl-alkylaryl.
Regarding claim 13, the compound above is the first compound of the instant claim.
Regarding claim 14, the compound above is embraced by the formula of the instant claim.
Regarding claim 15, Schinazi teaches that the pharmaceutical composition comprises a pharmaceutically acceptable carrier or excipient (claim 15).
Regarding claim 16, Schinazi teaches that the pharmaceutical composition is a transdermal composition or a nanoparticulate composition (claim 16).
Regarding claim 17, Schinazi teaches that the pharmaceutical composition further comprises a second Retinoic Acid Receptor-like Orphan Receptor (ROR) modulator from formula (A).
Regarding claims 18-19, Schinazi teaches that the pharmaceutical composition further comprises aspirin (claim 24).
Regarding claim 20, the claim recites “wherein the pancreatitis is…”, however, the method of the prior art is a method of treating a stroke. Claim 1, the claim from which claims 7 depends, recites that the disorder can be pancreatitis, sarcopenia, stroke glioblastoma and traumatic brain injury. As the limitations of claim 20 is to pancreatitis, the method of the prior art above reads on the claim. Regarding claim 21, the claim is also concerned with pancreatitis as the claim recites “associated with an increased risk of pancreatitis”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6-9 and 11-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/203, 874 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application claims a method for the treatment or prophylaxis of a disease affected by Retinoic Acid Receptor-like Orphan Receptor modulators, comprising administering an effective treatment amount of a compound of Formula (A) (claim 1). The copending application further claims that the compound of Formula (A) is
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(claim 6). Further, the copending application claims that the disease is brain cancers (claim 17).
Regarding claims 1-2, This compound is embraced by instant formula A, wherein Z is -C(O)-, X is -NH-, Y is -NH, A and B are phenyl, R2 is H, and R1 is C(O)R3, wherein R3 is heterocycloalkyl, substituted with R4, wherein R4 is aryl.
Regarding claims 3 and 6, X is -C(O) and Z is -NH-.
Regarding claim 7, Y is -NH.
Regarding claims 8-9, R2 is H.
Regarding claim 11, R2 is
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Regarding claim 12, R2 is -C(O)-heterocyclyl-alkylaryl.
Regarding claim 13, the compound above is the first compound of the instant claim.
Regarding claim 14, the compound above is embraced by the formula of the instant claim.
Regarding claim 15, the copending application claims that the compound is present in a pharmaceutical composition comprising a pharmaceutically acceptable carrier or excipient (claim 8).
Regarding claim 16, the copending application claims that the composition is a transdermal composition or a nanoparticulate composition (claim 9).
Regarding claim 17, the copending application claims that the composition further comprises a second ROR modulator from formula (A) (claim 10).
Regarding claim 18, the copending application claims that the composition further comprises one or more active agents selected from the group consisting of agents used to treat cancer (claim 12).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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/A.G.K./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626