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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/18/2026 has been entered.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: “1,5‐benzoxazepin‐4‐one Derivatives as RIPK1 Inhibitors”.
Election/Restrictions
Claim 1 is allowable. The restriction requirement of Groups I-III, as set forth in the Office action mailed on 10/25/2024, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 10/25/2024 is withdrawn. Claims 5-13 are no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Status of the Claims
Claims 1 and 4-13 are pending in this application. Claims 2-3 have been cancelled by Applicant.
Allowable Subject Matter
Claims 1, 4, and 9-10 are allowed.
Claim Objections
Claim 6 is objected to because in the last line, Examiner believes Applicant intended to say “(CVA, stroke)”.
Claims 11-13 are objected to because Applicant states: “wherein the disease is selected from the group consisting of . . .” - then lists a single category of disease. Claims should read: “wherein the disease is a/ an inflammatory disease/ neurodegenerative disease/ cancer.” for claims 11, 12, and 13, respectively.
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 5-8 and 11-13 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 6 recites the broad recitations: “inflammatory bowel disease”; “arthritis”; “liver damage/disease”; “kidney damage/injury”; and “cerebrovascular accident”. The claim also recites: “(including Crohn’s disease . . .)”; “(including rheumatoid . . .)”; “(non-alcoholic . . . )”; “(nephritis . . . )”; and “(CVA, stoke)” – see claim objection; which is the narrower statement of the range/limitation. Examiner suggests deleting parentheses and information contained therein, thus removing the narrower limitation, which raises ambiguity.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 6, the phrase "including" 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 5-8 and 11-13, claims are drawn to the “use of the compounds of claim 1” however, the claims omit the actual steps of using the compounds. Therefore, the resulting claims do not clearly set forth the metes and bounds of the patent protection desired. Examiner suggests amending claims as follows:
For claim 5: “A method of treating a disease involving both inflammation and necroptosis comprising administration of a compound of claim 1 to a subject in need thereof.
For claims 6-8: “A method of treating a disease comprising administration of a compound of claim 1 to a subject in need thereof, wherein the disease is . . . “ or something to that effect.
For claims 11-13: “The method of claim 6/7/8, wherein the disease is a/an inflammatory disease/neurodegenerative disease/cancer” respectively for claims 11-13 – Or something to that effect.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 5-8 and 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter.
Claims 5-8 and 11-13 are drawn to the use of the compounds of claim 1. The use of a compound without reciting specific steps of use does not fall within one of the four categories of eligible subject matter (process, machine, manufacture, or composition of matter).
See 112(b) section for suggestions for amending these claims.
Response to Arguments
Claims
Claim amendments are acknowledged and have been entered. No new matter has been introduced.
Claim Rejections - 35 USC § 103
In view of claim amendments, the 35 USC § 103 rejections of record have been withdrawn.
Double Patenting
The terminal disclaimer filed on 06/18/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Pat. No. 12,365,695 (US ‘695) has been reviewed and is accepted. The terminal disclaimer has been recorded.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. 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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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
