Detailed Action
The present office action is in response to the response filed on 03 Feb 2026.
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
Claims 1-3 of the pending application have been examined on the merits. Acknowledgement is made of the amendments filed 03 Feb 2026. Claims 4 and 6-12 of the pending application remain withdrawn. Acknowledgement is made of the cancellation of claim 5.
Priority
Applicants identify the instant application, Serial #: 17/624,348 filed 02 Jan 2022, as a National Stage Entry of International Patent Application #: PCT/US2020/040076, filed 29 June 2020, which claims priority from U.S. Provisional Application #: 62/869,040, filed 01 Jul 2019.
Response to Applicant Amendments
Examiner respectfully reminds applicant that claim withdrawal is done by the examiner. See MPEP § 821, 37 CFR 1.142(b), and 37 CFR 1.145. Examiner acknowledges the amendments of claims 4 and 7 in the reply filed 03 Feb 2026. Claim 1 remains the generic claim which reads on the elected species and is NOT withdrawn. Claims 2-3 remain under examination as being drawn to the elected species (see below). Election was made without traverse in the reply filed 26 Jan 2025.
The rejection of claims 1-3 under 35 U.S.C. § 102(a)(1) over STN (1,1-dimethylethyl N-[1-[(4-fluorophenyl)sulfonyl]-3-piperidinyl]carbamate, CAS 2199842-13-0, CAS Registry File Accessed 07 Apr 2025 from STN, entered into STN 27 Mar 2018) has not been overcome and is restated below.
In the reply filed 03 Feb 2026, applicant argues the newly amended claim 4 and 6-7 have been amended to recite a small group of compounds and that it would not be an extra burden on the examiner to examine the amended claims 4 and 6-7. Applicant is reminded that the instant application is subject to the “Unity of Invention” restriction standard and not the “Independent and Distinct/Undue Search Burden” restriction standard. Rule 13.1 of the Patent Cooperation Treaty (PCT) states, "the international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept.” Moreover, as stated in PCT Rule 13.2, "where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features." Furthermore, Rule 13.2 defines "special technical features" as "those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art."
Below is a restatement of the examiner’s response to applicant election of species which can also be found in the office action dated 21 Apr 2025.
Applicant’s election without traverse of the following compound:
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in the reply filed on 26 Jan 2025 is acknowledged. Examiner initiated a telephonic interview on 07 Apr 2025 with applicant to confirm positive election of the above compound.
Claims 4 and 6-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 Jan 2025.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN (1,1-dimethylethyl N-[1-[(4-fluorophenyl)sulfonyl]-3-piperidinyl]carbamate, CAS 2199842-13-0, CAS Registry File Accessed 07 Apr 2025 from STN, entered into STN 27 Mar 2018; provided in office action dated 21 Apr 2025), hereinafter STN.
Applicant claims a compound of Formula I in claim 1:
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Applicant has further elected the following compound as a single species of Formula I:
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Which can be made from Formula I when X and M are bonds; L is a heterocyclic bivalent group; R1 is -NH-CO-R10; R10 is -O-tert-butyl; Y is a bivalent benzyl group; and Z is halogen.
STN teaches a compound of the following structure:
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which anticipates the elected compound. Therefore claims 1-3 are rejected.
Conclusion
No claim is allowed. All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 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 CFR 1.17(a)) pursuant to 37 CFR 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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 use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625