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 1-19 and 21-35 are pending in this application.
Election/Restrictions
Applicant’s election of in the reply filed on Group I 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Claims 6-19 and 21-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 June 16, 2026.
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. 119(e) 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 application, Application No. 63/146,871, 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL. —The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 26-34 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In evaluating the enablement question, several factors are to be considered. In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988); Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed.
The nature of the instant invention has claims, which embrace substituted 2-methylbenzamide, 2-ethylbenzamide, 2-methoxybenzamide and 2-ethenylbenzamide compounds.
HOW TO USE: Claims 26-34 are drawn to the composition for use and the method of treating and/or preventing an infection, diseases, and symptoms thereof caused by coronavirus, including SARS-CoV-2 PLpro inhibiting activity. Any evidence presented must be commensurate in scope with the claims and must clearly demonstrate the effectiveness of the claimed compounds. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The scope of claims 26-34 per claim 30 includes diseases and/or conditions not even known at this time, which may be associated with SARS-CoV-2-PLpro inhibitor activity. While the treatment of infection has been linked with SARS-CoV-2 PLpro inhibitor the art does not recognize use of such inhibitors as broad-based drugs for treating all disorders instantly embraced. “Cancer”, “chronic kidney diseases”, “immunocompromised states”, “serious heart conditions”, “cerebrovascular diseases”, “neurologic conditions”, “liver diseases” in general is contrary to our current understanding of how pharmacologicals work. All attempts to find a pharmaceutical to treat cancer, chronic kidney diseases, immunocompromised states, serious heart conditions, cerebrovascular diseases, neurologic conditions, liver diseases, etc. generally have thus failed.
In view of the lack of direction provided in the specification regarding starting materials, the lack of working examples, and the general unpredictability of chemical reaction, it would take an undue amount of experimentation for one skilled in the art to make the claimed compounds and therefore practice the invention. To be enabling, the specification of a patent must teach those skilled in the art how to make and use the scope of the claimed invention without undue experimentation. The applicants are not entitled to preempt the efforts of others. The test for determining compliance with 35 U.S.C. § 112, is whether the applicants have clearly defined their invention.
It is difficult to treat many of the disorders claimed herein. Instant claim language embraces disorders not only for treatment but the prevention, which is not remotely enabled. It is presumed in the prevention of the diseases and/or disorders claimed herein there is a way of identifying those people who may develop a tolerance to opiate analgesia, etc. There is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the disorders claimed herein.
Where the utility is unusual or difficult to treat or speculative, the examiner has authority to require evidence that tests relied upon are reasonably predictive of in vivo efficacy by those skilled in the art. See In re Ruskin, 148 USPQ 221; Ex parte Jovanovics, 211 USPQ 907; MPEP 2164.05(a).
Patent Protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
As stated in the MPEP, 2164.08 ''[t]he Federal Circuit has repeatedly held that the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. ln re Wright, 999 F.2d 1557, 1561 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Nevertheless, not everything necessary to practice the invention need be disclosed. In fact, what is well known is best omitted. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991). AII that is necessary is that one skilled in the art be able to practice the claimed invention, given the Ievel of knowledge and skill in the art. Further the scope of enablement must only bear a reasonable correlation to the scope of the claims. See, e.g., In re Fisher, 427 F.2d 833, 839,166 USPQ 18, 24 (CCPA 1970). As concerns the breadth of a claim relevant to enablement, the only relevant concern should be whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). See also Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged pioneer status of invention irrelevant to enablement determination.''
Claims 31, 33 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In evaluating the enablement question, several factors are to be considered. In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988); Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed.
The nature of the instant invention has claims which embrace substituted 2-methylbenzamide, 2-ethylbenzamide, 2-methoxybenzamide and 2-ethenylbenzamide compounds. The method of use the pharmaceutical compositions of the instant invention where an additional active ingredient such as antiviral agents, vaccines, etc. are included in the compositions. The specification does not define that which is intended in the additional active ingredients, i.e. which antiviral agents, vaccines, etc. Antiviral agents include hypericin, darizmetinib, galidesivir, CMP-5, BF738735, azaribine, R 61837, HBR-0259, IQP-0528, tirilazad mesylate, UC-781, YM-53403, AMC-01, viroxime, epetirimod oxamisole TFA, GPS491, FV-100, WIN 54954, equrpimtrostat hydrochloride, (R,1R)-tenofovir amibufenamide, ABI-1968, DDG-39, rociclovir PM, GS-9191 PM, CMX-521, isomyosmine, somantadine, β-anomer, valganciclovir hydrochloride, vidarabine phosphate, peramivir, oxytetracycline hydrochloride, angelicin, esculin, stearyl glycyrrhetinate, 2,2’-anhydrouridine, (+)-usnic acid, 3-methoxycatechol, arbidol, 3-methoxyflavone, dodecyl gallate, pocapavir, SARS-CoV-2-IN-39, rupintrivir, tizoxanide, germacrone, cephalotaxine, oosporein, capsorubin, evixapodlin, enpatoran hydrochloride, isomangiferin, paederoside, edoxudine, pleconaril, isopimpinellin, alovudine, epigoitrin, cynarin, chaparrinone, bonafton, chrysophanein, dihydromullugin, etc. which neither supported nor contemplated.
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 1-5 and 25-35 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. The following reasons apply:
Claims 1, 3 and claims dependent thereon are vague and indefinite in that it is not known what is meant by “Y1--Y3” in the definition of the variables for Formula I, which is a range which does not particularly point out and distinctly claim the subject matter which applicants regard as the invention, i.e., it fails to indicate that which is embraced by the range. The definitions of each individual variable must be clearly set forth herein.
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by “Argroup” in the definition of Ar.
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the moieties -(C1-C6 alkylenyl)NC(O)Ra, -(C1-C6 alkylenyl) C(O)NRa in the definition of R41 and R42 which are not valence satisfied.
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the moiety “-NRaRb,” where the comma is part of the superscript.
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the moiety –(C1-C3 cc)Rc in the definition of R41 and R42.
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the second occurrence of -C1-C6 alkyl in the definition of R41 and R42.
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the moiety -C1-C6 alkyl in the definition of R41 and R42 which do not appear as subscripts for the carbon count as the other moieties are.
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the moieties -C1-C6 alkenyl and -C1-C6 alkynyl in the definition of Ra and Rb where there cannot be a C1 alkenyl or alkynyl.
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the second occurrence of Rc in the third line on page 3 of 24.
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the moiety -C1-C6 cycloalkyl where the smallest cycloalkyl possible it a C3.
Claim 26 contains a statement of intended use, which does not limit the scope of the claim under the broadest reasonable interpretation and therefore is not given material weight. Note In re Tuominen 671 F.2d 1359, 1360, 213 USPQ 89, 90 (C.C.P.A. 1982).
Claim 35 recites the limitation "
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89
130
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" in the compound 72 with respect to the definition of Rd. There is insufficient antecedent basis for this limitation in the claim.
Claim 35 is vague and indefinite in that it is does not end with a period indicating the end of the claim.
608.01(m) Form of Claims [R - 3]
The claim or claims must commence on a separate sheet and should appear after the detailed description of the invention.< While there is no set statutory form for claims, the present Office practice is to insist that each claim must be the object of a sentence starting with "I (or we) claim", "The invention claimed is" (or the equivalent). If, at the time of allowance, the quoted terminology is not present, it is inserted by the clerk. Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, >36 USPQ2d 1211< (D.D.C. 1995). ** >Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5 and 25-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schinazi et al., WO 2020/247665. Schinazi teaches the compounds, compositions and method of use the compounds of Formula I where Ar is naphthalen-1-yl; R41 is Me; R42 is CH2NHCH3; X is Me; Y1 is CH; Y2 is CH; Y3 is CH as set forth on page 74.
Claim(s) 1-5 and 25-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ghosh et al., WO 2010/022355. Ghosh teaches the compounds, compositions and method of use the compounds of Formula I where Ar is naphthalen-1-yl, quinoline-4-yl, etc.; R41 is Me; R42 is NH2, NHacetyl, CH2NH2, CH2NHCH3, CH2OH, etc.; X is Me; Y1 is CH; Y2 is CH; Y3 is CH as set forth in Compound 2, 24, 25, 29, 49, 50, 52, 54, and 2-34.
Claim(s) 1-5 and 25-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ratia et al., PNAS. Ratia teaches the compounds, compositions and method of use the compounds of Formula I where Ar is naphthalen-1-yl; R41 is Me; R42 is NH2 or NHacetyl; X is Me; Y1 is CH; Y2 is CH; Y3 is CH as set forth in Fig. 2A compound 6 and GRL0617.
Claim(s) 1-5 and 25-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shen et al., bioRxiv. Shen teaches the compounds, compositions and method of use the compounds of Formula I where Ar is naphthalen-1-yl, 2-(pyrrolidine-1-ylmethyl)thien-5-ylphenyl, isoquinolinyl, benzothien3-yl, 1-methylindol-3-yl, indol-7-yl, indol-3-yl, 1-methylindol-7-yl, indol-4-yl, benzothien-5-yl, carbazol-4-yl, 1-isoquinoline, thien-2-yl, pyrrol-3-yl, 5-methylthien-2-yl, etc.; R41 is Me, CH2OH, CH2CH2OH, CH2CH3, -CH2C(O)NHCH3, -CH2C(O)N(CH3)2; R42 is NH2, -NH(3-azetidine), -CH2NH-CH2-C(O)OH, NH(piperidin-4-yl), NHCO(azetidine-3-yl), NHCO(piperidin-4-yl), NH(1-methylpiperidin-1-yl), N(CH3)(1-methylazetidin-3-yl), CH2NH(azetidine-3-yl), CH2(3-carboxyazetidin-1-yl), CH2(4-carboxypiperidin-1-yl), N(CH3)(azetidine-3-yl), etc.; X is Me, CH=CH2; Y1 is CH or N; Y2 is CH or N; Y3 is CH as set forth in compound GRL0617, XR8-24, ZN-2-184, ZN-2-185, ZN-2-186, ZN-2-187, ZN-2-188-1, ZN-2-188-2, ZN-2-197, ZN-3-36, ZN-3-56, DY2-144, DY2-137, Dy2-138-2, ZN-3-3, ZN-3-41, ZN-3-55, ZN-3-57, ZN-3-13, ZN-3-19, ZN-3-61, ZN-3-32, ZN-3-3, ZN-3-34, ZN-3-35, DY2-97, DY2-116, DY2-117, XDY2-62, XDY2-58, YF4-134, YF4-136, YF4-137, YF4-145, DY2-125, ZN-3-45, DY-3-59, DY2-149, ZN-3-79, DY-2-153, ZN-3-36, ZN-3-40, ZN-3-80, XR8-8, XR8-9, XR8-30, etc.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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