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 the Claims
Claims 1-2 and 4-22 are pending. Claims 7-11 and 16-19 are withdrawn. Claims 1-2, 4-6, 12-15, and 20-22 are rejected.
Information Disclosure Statements
The Information Disclosure Statements (IDS’s) submitted on 9/29/2022, 10/21/2022, 12/1/2023, 5/14/2024, 10/31/2025 were considered by the Examiner.
Election/Restrictions
Applicant’s election of (2S, 5’R)-7-chloro-3’,4-dimethoxy-5’-methyl-6-(5-methyl-1,3,4-oxadiazol-2-yl)spiro[benzofuran-2,4’-cyclohex-2-ene]-1’,3-dione:
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, in the reply filed on 10/31/2025 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)).
**Note from Examiner: Applicant elected “with traverse”, but did not give a reason for the traversal.
Claims 1-2, 4-6, 12-15, and 20-22 are embraced by the applicant’s elected species and are therefore under examination. The elected species is not allowable.
Claims 7-11 and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Objection to Specification
The specification amendment filed on 9/29/2022 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. Specifically, the following new phrase is not supported by the application (as filed on [PCT filing date], 4/1/2021): “the entire contents of each of which are incorporated by reference herein.” 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. See MPEP 211.02 and MPEP 201.06(c)(IV). PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to 371 applications. This rejection may be overcome by deleting the aforementioned phrase.
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.
Claim 1, 2, 4-6, 12-15, and 20-21 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 instant claims 1 and 4, the structure of Formula (1) and its connectivity are very unclear:
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. For the purposes of examining, Examiner has used the following depiction from the instant specification, p. 4:
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. Examiner recommends replacing the instant claim figure(s) with the one shown supra, having clear connectivity from the instant specification, to overcome this rejection.
Claims 2, 5-6, 12-15, and 20-21 are additionally rejected for depending from an indefinite claim and failing to remedy the deficiencies.
Claim Rejections - 35 USC § 112
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 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. On bottom of p. 15, claim 12 (dependent on instant claim 1) indicates that “A” may be a “single bond”. There is no indication in independent claim 1 that “A” may be a single bond. 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.
Claims 20-22 are 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. Claims 20-22 all ultimately depend from instant claim 1 and do not call for/require the present of R3’. Independent claim 1 does not indicate that R3’ may be absent. 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 § 103
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, 2, 4-6, 12-15, and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saito et al. (US11407746; effective filing date 9/29/2017- prior art eligible under 102(a)(2)).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Saito teaches the method of treating a central inflammatory disease comprising delivering a compound of the following to a subject in need thereof:
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(see claim 1). Saito specifically discloses the following species in a subsequent dependent claim (claim 11, fifth compound):
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, which is drawn to the following structure:
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.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not specifically call for “delaying the onset of” a premature aging disorder, of the instant claims.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding the prior art species above and the instant claims 1-2, 4-6, 12-15, and 20-22, the prior art species is the Applicant’s elected species. The prior art species is embraced by a compound of instant Formula 1, wherein R1, R2 and R3 = C1 alkyl group (methyl group);
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=
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, A = 5-membered aromatic heterocyclic ring (see 112(d) rejection supra for R3’ issue). Concerning the limitation of the instant method claims: “delaying the onset of”, this embraces subjects who have not yet acquired the premature aging disorder, which is the entire population of subjects.
Regarding instant claims 1-2, 4-6, 12-15, and 20-22, the method would have been obvious to a skilled artisan to delay the onset of a premature aging disorder by administering a known compound, shown supra and the Applicant’s elected species, because delaying the onset of to a subject population would include subjects requiring the treatment of the prior art, central inflammatory disease. A PHOSITA would have been motivated to administer the elected species to a subject effectively with a reasonable expectation of success.
Specifically, regarding instant claims 2 and 5, the specific disorder/disease is irrelevant to the current claims because “delaying the onset of” embraces the entire subject population.
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.
(1 of 4) Claims 1-2, 4-6, 12-15, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 and 25 of copending Application No. 18996613 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims, 1-2, 4-6, 12-15, and 20-22, claim 1 of copending Application No. 18996613 is drawn to the following:
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. Claim 23, fifth structure, of the co-pending application is identical to the Applicant’s elected species, drawn to the following structure:
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.
Regarding instant claims 1-2, 4-6, 12-15, and 20-22, the method would have been obvious to a skilled artisan to delay the onset of a premature aging disorder by administering a known compound, shown supra and the Applicant’s elected species, because delaying the onset of to a subject population would include subjects requiring the treatment of the prior art, improving memory function. A PHOSITA would have been motivated to administer the elected species to a subject effectively with a reasonable expectation of success.
Specifically, regarding instant claims 2 and 5, the specific disorder/disease is irrelevant to the current claims because “delaying the onset of” embraces the entire subject population.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(2 of 4) Claims 1-2, 4-6, 12-15, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 7-25 and 27 of copending Application No. 19144019 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims, 1-2, 4-6, 12-15, and 20-22, claim 1 of the co-pending application is drawn to the following:
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and dependent claim 8 is drawn to the following:
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. Additionally, claim 27 of the copending case ultimately depends from claim 1 and recites the following:
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, which is the instant application elected species.
Regarding instant claims 1-2, 4-6, 12-15, and 20-22, the method would have been obvious to a skilled artisan to delay the onset of a premature aging disorder by administering a known compound, shown supra and the Applicant’s elected species, because delaying the onset of to a subject population would include subjects requiring the treatment of the prior art, improving glucose homeostasis. A PHOSITA would have been motivated to administer the elected species to a subject effectively with a reasonable expectation of success.
Specifically, regarding instant claims 2 and 5, the specific disorder/disease is irrelevant to the current claims because “delaying the onset of” embraces the entire subject population.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(3 of 4) Claims 1-2, 4-6, 12-15, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-28 and 30 of copending Application No. 19151009 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims, 1-2, 4-6, 12-15, and 20-22, claim 1 of the copending case is drawn to the following:
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and dependent claim 11 begins with the following:
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. Co-pending case claim 30, ultimately depending from claim 1 recites the following:
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, which is the instant application’s elected species.
Regarding instant claims 1-2, 4-6, 12-15, and 20-22, the method would have been obvious to a skilled artisan to delay the onset of a premature aging disorder by administering a known compound, shown supra and the Applicant’s elected species, because delaying the onset of to a subject population would include subjects requiring the treatment of the prior art, anhedonia. A PHOSITA would have been motivated to administer the elected species to a subject effectively with a reasonable expectation of success.
Specifically, regarding instant claims 2 and 5, the specific disorder/disease is irrelevant to the current claims because “delaying the onset of” embraces the entire subject population.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(4 of 4) Claims 1-2, 4-6, 12-15, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-25 and 27 of copending Application No. (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims, 1-2, 4-6, 12-15, and 20-22, claim 2 of the copending case is drawn to the following:
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and dependent claim 8 recites:
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Co-pending case claim 27, ultimately depending from claim 2 recites the following:
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, which is the instant application’s elected species.
Regarding instant claims 1-2, 4-6, 12-15, and 20-22, the method would have been obvious to a skilled artisan to delay the onset of a premature aging disorder by administering a known compound, shown supra and the Applicant’s elected species, because delaying the onset of to a subject population would include subjects requiring the treatment of the prior art, depression. A PHOSITA would have been motivated to administer the elected species to a subject effectively with a reasonable expectation of success.
Specifically, regarding instant claims 2 and 5, the specific disorder/disease is irrelevant to the current claims because “delaying the onset of” embraces the entire subject population.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGHAN C HEASLEY/ Examiner, Art Unit 1626
/KAMAL A SAEED/ Primary Examiner, Art Unit 1626