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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Claims 1, 83-95 and 99-101 are pending in the application.
This action is in response to applicants' amendment dated October 14, 2025. Claims 1, 83-85, 87 and 89 have been amended, claims 96-98 have been canceled and claims 99-101 are newly added.
Response to Amendment
Applicant's arguments filed October 14, 2025 have been fully considered with the following effect:
The applicant's amendments and arguments are sufficient to overcome the 35 U.S.C. 102(a)(1), anticipation rejection, labeled paragraph 8) in the last office action, which is hereby withdrawn.
With regards to the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 19) in the last office action, the applicant’s amendments and remarks have been fully considered but they are not persuasive. The applicants stated that the claims have been amended to expedite prosecution. However, the definition of RX where Rx is hydrogen (newly added in view of the definition of RP), halogen, -C(O)R1a, -C(O)OR1a, -C(O)SR1a, -C(S)R1a, and -C(S)OR1a is not described in the specification with respect to Formula I(a) nor any of the Formulae I-XX. First there is no Formula I(a) in the specification and the variable in Formula I-XX with respect to the definition of Y is NRN. The definition of RN in the specification is two part first, each RN is independently hydrogen, C1-6 alkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, C7-15 aralkyl, heteroaryl, or heterocyclyl; and RP is C1-6 alkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, C7-15 aralkyl, heteroaryl, or heterocyclyl; or second, each RN is independently C1-6 alkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, C7-15 aralkyl, heteroaryl, or heterocyclyl; and RP is hydrogen. Thus, the definition of RN or RX used by the applicants does not include halogen, -C(O)R1a, -C(O)OR1a, -C(O)SR1a, -C(S)R1a, and -C(S)OR1a and when RP is hydrogen the definition of RN or RX can be hydrogen.
Claims 1 and 83-95 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AlA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention, for reasons of record and stated above.
The applicants’ amendments are sufficient to overcome the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 20) in the last office action, which is hereby withdrawn.
With regards to the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 21) in the last office action, the applicant’s amendments and remarks have been fully considered but they are not persuasive. The applicants stated that the claims have been amended to expedite prosecution. However, the definition of RP where RP is -CHR1a-O-C(O)R1c, -CHR1a-O-C(O)OR1c, as well as newly added moieties 1-((cyclohexyloxy)carbonyloxy)ethyl and pivalyloxymethyl is not described in the specification with respect to Formula I(a) nor any of the Formulae I-XX. The definition of RP in the specification is two part first, when RN is independently hydrogen, C1-6 alkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, C7-15 aralkyl, heteroaryl, or heterocyclyl; and RP is C1-6 alkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, C7-15 aralkyl, heteroaryl, or heterocyclyl; or second, when RN is independently C1-6 alkyl, C2-6 alkenyl, C2-6 alkynyl, C3-10 cycloalkyl, C6-14 aryl, C7-15 aralkyl, heteroaryl, or heterocyclyl; and RP is hydrogen. Thus, the definition of RP does not include -CHR1a-O-C(O)R1c, -CHR1a-O-C(O)OR1c, as well as newly added moieties 1-((cyclohexyloxy)carbonyloxy)ethyl and pivalyloxymethyl.
Claims 89-95 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AlA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention, for reasons of record and stated above.
The applicant's amendments and arguments are sufficient to overcome the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections, labeled paragraph 22b) and d) in the last office action, which are hereby withdrawn. However, with regards to the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections, labeled paragraph 22a) and c) of the last office action, the applicant’s amendments and remarks have been fully considered but they are not persuasive.
a) The applicants stated that the claims have been amended to expedite prosecution. However, the definitions of R2, R3, R4, R5 and R6 still appear as a range, i.e. R2-R6.
Claims 1 and 83-95 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 applicant regards as the invention, for reasons of record and stated above.
c) The applicants stated that the claims have been amended to expedite prosecution. However, claim 93 and claim 91 are both still present and claim the exact same thing.
Claims 91 and 93 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 applicant regards as the invention, for reasons of record and stated above.
In view of the amendment dated October 14, 2025, the following new grounds of rejection apply:
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 89-95 and 101 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. The scope of composition and method of use claims are not adequately enabled solely based on the inhibition of amyloid-beta peptide activity provided in the specification.
HOW TO MAKE: 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 invention in the instant case, has claims which embrace a substituted phenyl sulfamoyl benzoate compounds.
HOW TO USE: Claims 89-95 and 101 are to the method of attenuating amyloid beta levels with compounds of claim 89 and the species of claim 99. Any evidence presented must be commensurate in scope with the claims and must clearly demonstrate the effectiveness of the claimed compounds. However, the specification provides no definitive evidence to correlate any one disorder selected from those disclosed in the specification with the instantly disclosed phenyl sulfamoyl benzoate compounds.
The scope of claims 89-95 and 101 include diseases and/or disorders not even known at this time, which may be associated with amyloid-beta peptide aggregation. While the treatment of Alzheimer's disease may be linked with amyloid-beta peptide activity, the art does not recognize use of such inhibitors as broad-based drugs for treating all disorders instantly embraced.
No screening protocol(s) are ever described. Thus, no evidence of in vitro effectiveness is seen in the specification for one of the instantly claimed phenyl sulfamoyl benzoate compounds. In general, pharmacological activity is a very unpredictable area. In cases involving physiological activity "the scope of the enablement obviously varies inversely with the degree of unpredictability of the factors involved." In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970). Since this case involves unpredictable in-vivo physiological activities, the scope of the enablement given in the disclosure presented here was found to be low.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
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.
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.''
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 and 83-88 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 pre-AIA the applicant regards as the invention. The following reason(s) apply:
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the definition of R1c where there is no variable R1c in Formula I(a).
Claim 88 recites the limitation "hydrogen" in R1a where there is no R1a in claim 87 from which claim 88 depends. There is insufficient antecedent basis for this limitation in the claim.
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 and 83 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orton, U.S. Patent No. 9,416,101. Orton teaches the compounds of Formula I where X is SO2; Y is NH or N(CH3); RP is H; R2 is H, OMe, etc.; R3 is H, OMe, CF3, etc.; R4 is F, Cl, CF3, OMe, -O-CH2-phenyl, etc.; R5 is H; R6 is H; as set forth in compounds in column 85 and 86, i.e. 4, 5, 6, 7, 10, 11, 12, 13, 14, 16 and the intermediates of examples 11, 12, 13, 14, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 32, 61, etc.
Claim(s) 1, 83 and 89 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Inoue et al., U.S. Patent Application Publication No. 2012/0094964. Inoue teaches the compounds of Formula I where X is SO2; Y is N(CH2phenyl), N(CH2CH2morpholinyl), N(CH2pyridin-2-yl), N(CH2CH2piperidin-1-yl), N(CH2(4-Cl-phenyl)), etc.; RP is H; R2 is H, Cl, OMe, OEt, etc.; R3 is H, CF3, etc.; R4 is H, CF3, Cl, OMe, etc.; R5 is H; R6 is H; as set forth in examples 56, 81, 82, 83, 111, 112, 113, 114, 115, 116, 125, etc.
Claim(s) 1 and 83 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao et al., CN 105985265. Zhao teaches the compounds Formula I where X is SO2; Y is N(CH3) or N(H); RP is H; R2 is H; R3 is H or OMe; R4 is H; R5 is H; R6 is H or OMe; as set forth in paragraph [0110], [0114], [0118], etc.
Claim(s) 1, 83 and 89 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanke et al., Bioorganic & Medicinal Chemistry. Hanke teaches the compounds of Formula I where X is SO2; Y is N(CH2phenyl), N(Et) or N(butyl); RP is H; R2 is H; R3 is H; R4 is H; R5 is H; R6 is H; as set forth in examples 11, 24, 25, etc.
Claim(s) 89 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al., WO 2018/156297. Yang teaches the compounds and compositions of Formula I(a) where X is SO2; Y is N(C(O)CH=CH2); RP is CH3; R2 is H; R3 is H; R4 is F; R5 is H; R6 is Cl; as set forth in example 24.
Claim(s) 1, 83 and 89 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Birault et al., U.S. Patent Application Publication No. 2017/0081278. Birault teaches the compounds and compositions of Formula I(a) where X is SO2; Y is N(CH2-CH(CH3)2); RP is H or CH3; R2 is CH3; R3 is H; R4 is CH3; R5 is H; R6 is H; as set forth in examples P71, P179, P180, P181, etc.
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 89-93 and 95 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 83, 84, 93-100, 105-109 of copending Application No. 17/625,704 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the composition of claim 89 is embraced by the compounds, compositions and method of use of the compounds of Formula A of 17/625,704 where RP is H.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 83-93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 83-101 of copending Application No. 18/817,959 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound and composition of claims 1 and 83-93 is embraced by the compounds, compositions and method of use of the compounds of Formula (I) of 18/817,959 where RP is H.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 89-95 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,701,334. Although the claims at issue are not identical, they are not patentably distinct from each other because the composition of claim 89 is embraced by the compounds, compositions and method of use of the compounds of Formula (I) of U.S. ‘334 where RP is H.
Allowable Subject Matter
Claims 99 and 100 are allowed. None of the prior art of record or a search in the pertinent art area teaches the two species claimed herein.
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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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624