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 .
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.
Claims 2-3, 8-9, 14-15, 19-21, 24, 29, 33, 36-38, 56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/08/2025.
Applicant’s elected with traverse Group I and elect the compound shown below, claims 1, 12, 41 and 55 encompass the elected group and the elected species, in the reply filed on 10/08/2025 is acknowledged. Claim 2 does not encompass the elected species.
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The elected species has been searched and found to be 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 1, 12, 41 and 55. Claims 1, 12, 41 and 55 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the elected species has been found not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration.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 1, 12, 41 and 55 contain formulas Id-Ig that are not supported by the prior applications and thus were given a priority date of 02/23/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/21/2022, 02/13/2023, 04/30/2024 are being considered by the examiner.
Drawings
The drawings are objected to because it is impossible to tell from the key given in the drawing the difference between No virus and SARS-CoV-2 because the colors/patterns are so similar. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 12, 41 and 55 are objected to because of the following informalities: benzthiazole is misspelled and should be benzothiazole. 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, 12, 41 and 55 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.
Regarding claims 1, 12 and 55 , the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 1, 12 and 55, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 1, 12 and 55, the phrase --including -- renders the claim indefinite because it is unclear . whether the limitations following the phrase are a required part of the claimed invention. | See MPEP § 2173.05(d).
The scope of claims 1, 12, 41 and 55 is indefinite because the elected species and the examples in claim 41 allow substitution on the heterocyclo or cycloalkyl of R2 but this is not defined. Thus it is unclear if the scope of these claims is meant to included substituted groups on R2.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “heterocyclo” in claim 1 is used by the claim to mean “heterocyclyl that is substituted,” while the accepted meaning is that is not a real word. The term is indefinite because the specification does not clearly redefine the term. The term “cycloalkyl” in claim 1 is used by the claim to mean “any carbon ring,” while the accepted meaning is “saturated carbon rings.” The term is indefinite because the specification does not clearly redefine the term.
The scope of claim 12 is unclear because there is no definition given in the claims from which claim 12 depends or claim 12 itself for R3 or R1. Thus the structure of the compounds claimed in claim 12 are undefined and indefinite. R1 is later defined in claim 41 but this is not a claim that claim 12 depends on.
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.
Claim 12, 41 and 55 is 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 41 improperly broadens claim 1 from which it depends because it includes a Ph group as the R4 group this is not a group listed under R4 in claim 1. If this was meant to be the phenylalanine side chain it is missing a carbon and so is not correct. If it is meant to be a cycloalkyl this is not a standard definition as generally cycloalkyl are understood not to be aromatic. No alternative definition has been given by the applicant and so claim 41 was rejected. Additionally, the examples in claim 41 allow substitution on the heterocyclo or cycloalkyl of R2 but this is not defined as being allowed in claim 1. Thus it is unclear if the scope of these claims is meant to included substituted groups on R2 or if claim 41 is improperly broadening the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1, 12 and 41 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Thanigaimalai (P. Thanigaimalai et al. / European Journal of Medicinal Chemistry 68 (2013) 372e384).
The reference Thanigaimalai teaches the following compound (Table 1 compound 5g), 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, R1= wherein R¹ is alkoxy ([00209] instant specifications, since not defined in claims), Rd=H, R3= is not defined but based on elected species is included under this claim R3=R3a, n=1. This anticipates claims 1 and 12.
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The reference Thanigaimalai teaches the following compound (Table 1 compound 5k). This is the exact same compound as instant claim 41 page 20 bottom left. This anticipates claims 41.
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Claim(s) 1 and 55 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by LIU (LIU et al. WO-2017114509-A1, 2017-07-06).
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The reference Liu teaches the following compound (page 11), wherein it is formula (I), A= A is alkyl substituted heterocyclyl, R4= cycloalkyl, R2 is a heterocyclo, R3a= H. This anticipates claim 1.
The reference Liu teaches “The present invention also relates to a pharmaceutical composition comprising a therapeutically effective amount of one or more selected from aldehyde compounds represented by formula (I), pharmaceutically acceptable salts thereof, their prodrugs, and their hydrates and solvates, and optionally, a pharmaceutically acceptable carrier, which may be used to treat diseases related to enterovirus and coronavirus replication” (Translation page 33). This anticipates claim 55.
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.
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, 12, 41, and 55 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 1, 12, 41, and 55.
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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.
Conclusion
Claims 1, 12, 41, and 55 are rejected.
Claims 2-3, 8-9, 14-15, 19-21, 24, 29, 33, 36-38, 56 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR SALAMATIAN 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.S./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627