DETAILED ACTION
A non-final Office action was mailed 10 September 2025 (“Office Action”).
Applicant’s reply to the Office Action was received 9 March 2026 (“Reply”).
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 20 and 44–50 are pending. Claims 1–19 and 21–43 are canceled.
Claim 20 is amended. Claims 44–50 are new.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code and/or text providing the basis for non-statutory double patenting rejections not included in this action are set forth in the Office Action.
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 9 March 2026 is acknowledged and has been considered.
Double Patenting
Claims 20 and 44–50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 10 of U.S. Pat. No. 11,434,222 (“reference” claims, patent, or specification) [IDS].
18/252,611
11,434,222
1. A method of treating a subject having epilepsy, comprising administering to the subject a therapeutically effective amount of a compound of Formula (I) that is:1,1,1,3,3,3-hexafluoropropan-2-yl (S)-1-(pyridazin-3-ylcarbamoyl)-6- azaspiro[2.5]octane-6-carboxylate, or a pharmaceutically acceptable salt thereof; or 1,1,1,3,3,3-hexafluoropropan-2-yl (S)-1-((tetrahydro-2H-pyran-4-yl)carbamoyl)- 6-azaspiro[2.5]octane-6-carboxylate, or a pharmaceutically acceptable salt thereof.
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The instant claims are directed to a method of treating epilepsy by administering one of two different compounds (above left).
Reference claim 8 is directed to 20 compounds or salt thereof, including the two compounds recited in the instant claims, and reference claim 10 is directed to a one of the compounds or salt thereof in the instant claims (above right).
The reference claims do not recite a utility of the compounds.
The reference specification can be reviewed to ascertain the utility of a claimed compound when it is not apparent from the claims. MPEP § 804(II)(B)(1) (“The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed.”).
The reference specification discloses a utility for the compounds as MAGL inhibitors and for the treatment of various diseases, including epilepsy. (1:11–51; 2:41–67) (col:lines).
Although the claims at issue are not identical, they are not patentably distinct from each other because they cover essential parts of the same invention (the same compounds having the same utility). As such, the instant claims would have been prima facie obvious in view of the reference claims. Furthermore, an infringer of a patent granted based on the instant claims would also be an infringer of the reference claims.
Response to Arguments
Applicant’s arguments submitted with the Reply have been fully considered but are not persuasive. Applicant argues, “claims 1-12 of the ’222 patent do not recite a method of treating a disease, much less the specific disease that is epilepsy, as instantly claimed. In fact, neither the group consisting of the two specific compounds of examples 6 and 8, nor the particular indication of treating epilepsy, is disclosed” in the reference claims. (Remarks, p.6).
The instantly claimed compounds are recited in the reference claims. While the reference claims do no recite a method of treating a disease, epilepsy is specifically disclosed as a utility in the reference patent for the claimed compounds. In Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Co., 611 F.3d 1381 (Fed. Cir. 2010), the court explained, “the holding [ ] that a ‘claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use,’ extends to any and all such uses disclosed in the specification of the earlier patent.” (Sun, at 1387). This rejection is consistent with established law and, therefore, Applicant’s argument is not persuasive.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 C.F.R. § 1.17(a)) pursuant to 37 C.F.R. § 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to submit an Automated Interview Request: http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.M.N./Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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