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 .
Response to Amendment
The amendment file on 3/23/2026 in response to the Non-Final rejection of 11/20/2025 is acknowledged and has been entered.
Claims 60-62 and 66-79 are currently pending and under consideration.
The species election is withdrawn in view of Applicants amendments.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed on 3/23/2026 is acknowledged and has been considered except where lined through.
Rejections Withdrawn in view of Amendments:
The rejection of claims 60-62, 64 and 66-79 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention are withdrawn in view of the amendment to claim 60.
The rejection of claim(s) 60-62, 64, 67, 72 and 77-78 under 35 U.S.C. 102 a(1) as being anticipated by Crew et al. (US20180179183A1, 2018-06-28) is withdrawn in view of the Amendment to claim 60 to limit the compound of Formula I RING A to be Formula A-5 wherein X1 and X2 are N.
The rejection of Claim(s) 60-62, 69, 70-74 and 77-78 under 35 U.S.C. 102(a)(2) as being anticipated by Plewe et al. (US20230093099A1, 2023-03-23) is withdrawn in view of the amendment to claim 60 to limit the compound of Formula I RING A to be Formula A-5 wherein X1 and X2 are N and R11 does not include an optionally substituted aryl.
The provisional rejection of Claims 60-62, 69, 70-74 and 77-78 on the ground of nonstatutory double patenting as being unpatentable over claims 18, 58, 74-76, 79-80 and 104 of copending Application No. 17600,808 (reference application) is withdrawn in view of the amendment to claim 60 to limit the compound of Formula I RING A to be Formula A-5 wherein X1 and X2 are N and R11 does not include an optionally substituted aryl.
New Rejections Necessitated by Amendment:
Compact Prosecution
A telephone call was made to Applicants representative, Christina Hoong, on 4/6/2026 to discuss the rejections set forth below and potential examiners amendment. Applicants representative requested an office action so that Applicants can have more time.
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 76 is 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.
Claim 76 recites the limitation " 2-(2,6-dioxopiperidin-3-yl)-5-((6-oxo-6-(4-(4-(quinolin-2-yl)-1H-pyrazol-1-yl)piperidin-1-yl)hexyl)amino)isoindoline-1,3-dione (GS-006)”. In view of the specification, GS-006 has the following structure
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which does not have X2 as a Nitrogen. As such, there is insufficient antecedent basis for this limitation in the claim.
Conclusion
Claims 60-62, 66-75 and 77-79 are in condition for allowance.
The closest prior art is considered to be Plewe et al. (US20230093099A1, 2023-03-23), as set forth in the prior Non-Final rejection. However, Plewe et al. differs from the instantly claimed compound in that the claimed compound of Formula I RING A is Formula A-5 wherein X1 and X2 are N and R11 does not include an optionally substituted aryl. The prior art does not teach or suggest specific modification at the bicyclic ring with a variable other than an aryl ring.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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