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 .
Claim 13 has been cancelled. Claims 15-18 have undergone amendments. Thus, Claims 15-21, submitted on 4 August 2026, represent all claims currently under consideration.
Election/Restrictions
A complete search for the species of Claim 15 returned no prior art (See STN Search, Search Notes). Claim 15 is directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 18-21, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 16 December 2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are 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 Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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.
Claims 15-21, submitted on 4 August 2026, represent all claims currently under consideration.
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.
Response to Arguments
The objection to the specification is withdrawn. Applicant has amended the specification to correct the objection.
The 35 U.S.C. § 112(a) rejection of Claims 13 and 15-17 is withdrawn. Applicant has cancelled Claim 13 and has amended Claims 15-17 to remove both “isomer” and “prodrug” as limitations.
The 35 U.S.C. § 102 (a)(1) rejections of Claim 13 over Thriveni, Mistry, and STN RN 2109067-90-3 are each withdrawn. Applicant has cancelled Claim 13, rendering these rejections moot.
The 35 U.S.C. § 102(a)(1) rejections of Claims 13, 16, and 17 over Carruthers, over Pick, and over Nuss are each withdrawn. Applicant has cancelled Claim 13, rendering these rejections moot.
The 35 U.S.C. § 102 (a)(1) rejection of Claims 13 and 15 over STN RN 1264098-61-4 is withdrawn. Applicant has removed “isomer” from the claim limitations, rendering this rejection moot, and as there is no biological activity demonstrated for this compound, there is no motivation to modify the structure to arrive at the compound of Claim 15.
The 35 U.S.C. § 103 rejection of Claims 13, 16, and 17 over Thriveni is withdrawn. Applicant has cancelled Claim 13, rendering the rejection moot.
Claim Objections
Claim 15 is objected to because of the following informalities: There should be an “or” or “and” prior to the final compound in the table of species of Claim 15. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: The compound
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appears to be denoting an alkene attached to the central fused ring system but the image is corrupted. Appropriate correction is required.
Response to Amendment
Claim Rejections - 35 USC § 112- DUE TO APPLICANTS AMENDMENT
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 16 and 17 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. Claim 16 is directed to a pharmaceutical composition comprising the compound of Claim 15 (emphasis added). There are multiple compounds claimed in Claim 15, causing indefiniteness as to which specific compound is to be used in the compositions of Claim 16 and 17. The Examiner suggests amending Claim 16 to recite “comprising a compound” to overcome this rejection. Claim 17 is similarly rejected as indefinite for depending upon an indefinite claim without resolving the underlying issue of indefiniteness.
Claim Rejections - 35 USC § 112(b)- NEW GROUNDS OF REJECTION
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 18-20 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. Claim 18 is indefinite as it is drawn to a method for treating CTLA-4 related diseases (plural). It is unclear if the patient in need thereof requires multiple diseases for this method to be practiced, or if the patient can be suffering from a singular disease. The Examiner suggests amending the Claim to recite “for treating a CTLA-4 related disease” to overcome this rejection. Claims 19 and 20 are similarly rejected as indefinite for depending upon an indefinite claim without resolving the underlying issue of indefiniteness. Claim 19 should similarly be amended to recite “characterized in that the CTLA-4 related disease” and each of the conditions which follow should be in the singular form.
Claim 19 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 19 is indefinite because of the limitation “includes” prior to each of the disease states. It is unclear if the limitations which follow are necessary parts of the invention, or are merely representative. The Examiner suggests amending the claim to recite “characterized in that the CTLA-4 disease is selected from cancer, an autoimmune disease, an immunodeficiency disease, a viral infection, and an organ transplant rejection”.
Claim 20 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 20 is indefinite due to each instance of the parentheticals which read “including but not limited to” and “such as”. This causes indefiniteness as it is unclear if the limitations which follow are merely exemplary or are necessary parts of the invention. The Examiner suggests amending the claim to remove the ”including” parentheticals and to specifically state each of the cancers which are found within the parentheses as limitations.
Claim 20 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 20 is indefinite due to the limitation of “other related cancers”. This is not a term of the art as the artisan would not know what a related cancer to those which are claimed is. It is unclear from the specification what an “other related cancer” comprises, causing the metes and bounds of the claim to be undefined, and therefore, indefinite.
Claim 21 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 21is indefinite as it is drawn to a method for treating CTLA-4 related diseases (plural). It is unclear if the patient in need thereof requires multiple diseases for this method to be practiced, or if the patient can be suffering from a singular disease. The Examiner suggests amending the Claim to recite “for treating a CTLA-4 related disease” to overcome this rejection.
Allowable Subject Matter
Claim 15 is objected to, but otherwise allowable.
Claims 16-21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance: There is no prior art which teaches, suggests or provides motivation for the specific compounds of Claim 15 of the examined application (See STN Search, Search Notes). The closest art comes from Carruthers (WO 2010/053825; Publication Date: 14 May 2010) (See IDS, 29 November 2024), Pick (WO 2007/084786; Publication Date: 26 July 2007), and Nuss (WO 2004/048365; Publication Date: 10 June 2004). As described in the prior office action, Carruthers, Pick, and Nuss each disclose compounds and their compositions which are of similar structure to those of the examined application (such as
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of Nuss,
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of Pick, and
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of Carruthers). However, Applicant has amended Claim 15 to recite specific compounds, and removed the limitation of “isomer”. These specific compounds are not disclosed in the prior art, nor is there any teaching, suggestion, or motivation found to modify the compounds of Carruthers, Pick, or Nuss to arrive at those which are claimed. As the compounds which are claimed are free of prior art, methods of treatment comprising administering these compounds are similarly free of prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claim 15 is objected to, but otherwise allowable.
Claims 16-21 are rejected.
THIS ACTION IS MADE FINAL. 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 PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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/P.M.R./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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