DETAILED ACTION
All objections and rejections not mentioned below have been withdrawn.
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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 10/08/2025 is acknowledged. The traversal is on the ground(s) that Group I and Group V can be examined in the same application without undue burden on the Patent Office. This is not found persuasive because there is undue burden to the examiner as Group I claims compounds while Group V claims methods these require different fields of search for example they require different search queries. For example compounds can be searched in CAS Registry but methods cannot. Undue burden can be established by different search quires as stated in MPEP 808.02.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s elected with traverse Group I and elect the compound shown below, claims 12, 55, 62, 68-69, and 72-73 encompass the elected group and the elected species, in the reply filed on 10/08/2025 is acknowledged.
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Claims 56, 58-61, 63-67, 70, 71 and 74 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group or species, there being no allowable generic or linking claim.
The elected species has been searched and found obvious over the prior art. Thus the scope of the search was halted at the elected species. Since the elected species has been found not allowable, examination has been limited to claims directed to the elected species, which are presently claims 12, 55, 62, 68-69, 72-73. Claims 12, 55, 62, 68-69, 72-73 have been examined to the extent that they are readable on the elected embodiment. Since the elected species has been found not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 63/014,501 and 63/120,079, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Examined claims 12, 55, 62, 68-69, and 72-73 contain R2 = oxopiperidyl that is not supported by the prior applications and thus were given a priority date of 02/23/2021. This is in agreement with the of the same conclusion drawn by the Australian patent report provided in the latest IDS.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/21/2022, 02/13/2023, 04/30/2024 and 05/21/2026 are being considered by the examiner.
Claim Rejections - 35 USC § 102 – New Due to Amendment and IDS
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) 12, 55, 68-69, 72 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by LIU (LIU et al., WO2020030143 A1, 2020-02-13, IDS).
The reference Liu teaches the following compound A95 (page 22), wherein R2= oxopiperidyl, Rd=H, n=0, R4= is a natural amino acid side chain (valine), R3=R3a=acyl. This anticipates claims 12, 68-69, 72.
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The reference Liu teaches “A pharmaceutical composition, characterized in that the pharmaceutical composition comprises the following components:
i) a therapeutically effective amount of one or more ketoamide compounds of claim 1, their racemic mixtures, enantiomers, diastereomers, or mixtures thereof, or their pharmaceutically active metabolites, or their pharmaceutically acceptable salts, solvates, or prodrugs; and
ii) Pharmaceutically acceptable carriers or excipients” (reference claim 8). This anticipates claim 55.
Claim Rejections - 35 USC § 103- Updated Due to Amendments
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.
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) 12, 55, 62, 68-69, 72 and 73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thanigaimalai (P. Thanigaimalai et al. / European Journal of Medicinal Chemistry 68 (2013) 372e384).
The reference Thanigaimalai teaches the following compound (Table 1 compound 5h), wherein the compound is formula (I), A= A is alkoxy substituted heterocyclyl, R4= is a natural amino acid side chain, valine, R2 is a heterocyclo, R3a= benzthiazole. This helps to teach claims 12, 55, 62, 68-69, 72 and 73.
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The reference Thanigaimalai teaches “We report the design and synthesis of a series of dipeptide-type inhibitors with novel P3 scaffolds that display potent inhibitory activity against SARS-CoV 3CLP'°”(abstract).
The reference Thanigaimalai does not teach the exact elected species (all claims) it has a five membered ring instead of a six membered ring and it does not teach a pharmaceutically acceptable excipient.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Thanigaimalai to get the elected species because the only difference between the two compound is one -CH2- unit. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Thus one of ordinary skill in the art would have a reasonable expectation that adding one -CH2- unit would also have similar inhibitory activity against SARS-CoV 3CLP' and thus would have been motivated to do so to also treat severe acute respiratory syndrome. One of ordinary skill in the art would have a reasonable expectation to add a pharmaceutically acceptable excipient to the chemicals and chemicals derivatives that are obvious from the reference because they are suggested as possible drugs and one would be motivated to do so since many drugs are well known to be used with pharmaceutically acceptable excipients for example dilution with water for improved delivery.
Response to Arguments
Applicant's arguments filed 05/27/2026 have been fully considered but they are not persuasive.
The applicant argues that the addition of one CH2 unit would not be an obvious modification and just because they are homologs their properties would still be considered unpredictable in view of the prior art as a whole. Thus one would not expect that the homologs would have similar properties and thus would not have similar activity to treat SARS CoV2. Then the applicant provides data showing that small structural changes in related species in the prior art gave unpredictable effects.
In response to this argument the examiner cites ARNOLD (ARNOLD et al., US2023212152A1, effective filing date 2020-10-14). Which provides support that such small changes such as a CH2 homolog ring expansion was considered in the prior art before the effective filing date of the instant invention for a compound of similar structure to have similar activity for viral infection such as SARS CoV2. Thus this provides support for the 103 above because it shows one of ordinary skill in the art would have considered such homologs to have similar activity due to similar structure prior to the instant invention. See reference claims 1,9, and 26-34:
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And wherein claim 9 teaches the 6 remembered homolog is also expected to have the same activity as the 5 membered homolog. Which is pointed out by claim 29 also citing claim 9. Thus applicants argument is unpersuasive.
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Conclusion
Claims 12, 55, 62, 68-69, and 72-73 are rejected.
Claims 56, 58-61, 63-67, 70, 71 and 74 are withdrawn.
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 ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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