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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/6/2026 has been entered.
Election/Restriction
The examiner notes for clarity of the record that inventor has added new claims 16-21. The subject matter of these new claims is encompassed by the original election/restriction requirement (an election of species across the entire claim set).
102 Rejections Withdrawn
The rejection of claim 3 under 35 USC 102(a)(1), outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment narrows the claim scope (to a pharmaceutical composition) such that it no longer reads on the cited art.
Claim Objections Withdrawn
The objection to claims 4-14, outlined in the previous Office Action is withdrawn. (With respect to claims 5-8, the amendment cancels the claims.)
Markush Search
Inventor having overcome the outstanding art rejection, the search was expanded as called for under Markush examination practice, a compound-by-compound search. This resulted in all remaining species being searched.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 4, 12 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 and 16 of U.S. Patent No. 11,752,118 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Inventor teaches a method of treating cancer comprising administering a pharmaceutical composition of a benzenesulfonamide derivative selected from the 4 diagramed benzenesulfonamide derivatives of pharmaceutical composition claim 3 (claim 4). Claim 12 (from claim 4) teaches that the composition is administered intratumorally, intravenously, subcutaneously, etc. Claim 13 (from claim 4) teaches that the cancer is inter alia skin cancer.
US 11,752,118 B2 teaches a method of treating melanoma comprising administering a pharmaceutical composition of a benzensulfonamide derivative chosen from a list of diagramed compounds which explicitly includes the 4 diagramed compounds of instant claim 3 (column 23, line 65 (i.e. the last diagramed compound); column 25, lines 20, 40 and 45 (i.e. the 4th, 7th and last diagramed compounds)) (claim 9). The explicitly diagramed list of compounds is a subset of a larger Markush set of compounds which are administered intratumorally, intravenously, subcutaneously, etc. (claim 16).
As can be seen from the outlines above, the subject matter of the claim sets are related, essentially, in a genus/species fashion. That is, the instant claim set is a broader teaching (cancer) than the narrower teaching of the patented claims (melanoma). Note, however, that if a generic claim is presented in a separate application after the issuance of a patent claiming one or more species within the scope of the generic claim, the generic claim may be rejected on the grounds of nonstatutory double patenting. (MPEP 806.04(i).)
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 11,752,118 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Inventor teaches a method of treating cancer comprising administering a pharmaceutical composition of a benzensulfonamide derivative selected from the Markush group of compounds of Formula (I) of compound claim 16.
US 11,752,118 B2 teaches a method of treating melanoma comprising administering a pharmaceutical composition of a benzensulfonamide derivative chosen from a list of diagramed compounds which explicitly includes a compound encompassed by the Markush group of Formula (I) of instant claim 16 (column 25, line 20 (i.e. the 4th diagramed compound)).
As can be seen from the outlines above, the subject matter of the claim sets are related, essentially, in a genus/species fashion. That is, the instant claim set is a broader teaching (cancer; Markush group of Formula (I)) than the narrower teaching of the patented claim (melanoma; a diagramed member of the Markush group of instant formula (I)). Note, however, that if a generic claim is presented in a separate application after the issuance of a patent claiming one or more species within the scope of the generic claim, the generic claim may be rejected on the grounds of nonstatutory double patenting. (MPEP 806.04(i).)
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 11,752,118 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Inventor teaches a method of treating cancer comprising administering a pharmaceutical composition of a benzensulfonamide derivative selected from the Markush group of compounds of Formula (I) of compound claim 15.
US 11,752,118 B2 teaches a method of treating melanoma comprising administering a pharmaceutical composition of a benzensulfonamide derivative chosen from a list of diagramed compounds which explicitly includes compounds encompassed by the Markush group of Formula (I) of instant claim 15 (column 23, line 65 (i.e. the last diagramed compound); column 25, lines 20 and 40 (i.e. 4th and 7th diagramed compounds).
As can be seen from the outlines above, the subject matter of the claim sets are related, essentially, in a genus/species fashion. That is, the instant claim set is a broader teaching (cancer; Markush group of Formula (I)) than the narrower teaching of the patented claim (melanoma; diagramed members of the Markush group of instant formula (I)). Note, however, that if a generic claim is presented in a separate application after the issuance of a patent claiming one or more species within the scope of the generic claim, the generic claim may be rejected on the grounds of nonstatutory double patenting. (MPEP 806.04(i).)
Claims 4 and 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 5 and 19 of U.S. Patent No. 12,409,158 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Inventor teaches a method of treating cancer comprising administering a pharmaceutical composition of a benzensulfonamide derivative selected from the 4 diagramed benzenesulfonamide derivatives of pharmaceutical composition claim 3 (claim 4). Claim 12 (from claim 4) teaches that the composition is administered intratumorally, intravenously, subcutaneously, etc. Claim 13 (from claim 4) teaches that the cancer is inter alia lung cancer and skin cancer. Claim 14 (from claim 13) teaches the cancer is liver cancer or lung cancer.
US 12,409,158 B2 teaches a method of treating cancer comprising administering a chemotherapy agent and a pharmaceutical composition of a benzensulfonamide derivative chosen from a list of diagramed compounds which explicitly includes the 4 diagramed compounds of instant claim 3 (column 31, line 50 (i.e. the 9th diagramed compound); column 33, lines 10, 25 and 30 (i.e. the 2nd, 5th and last diagramed compounds)) (claim 4). The explicitly diagramed list of compounds is a subset of a larger Markush set of compounds which are administered intratumorally, intravenously, subcutaneously, etc. (claim 19), and where the cancer is melanoma or lung cancer (claim 5).
As can be seen from the outlines above, the subject matter of the claim sets are related, essentially, in a genus/species fashion. That is, the instant claim set is a broader teaching (comprising the diagramed benzenesulfonamide derivatives) than the narrower teaching of the patented claims (comprising the diagramed benzensulfonamide derivatives and a chemotherapy agent). Note, however, that if a generic claim is presented in a separate application after the issuance of a patent claiming one or more species within the scope of the generic claim, the generic claim may be rejected on the grounds of nonstatutory double patenting. (MPEP 806.04(i).)
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,409,158 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Inventor teaches a method of treating cancer comprising administering a pharmaceutical composition of a benzensulfonamide derivative selected from the Markush group of compounds of Formula (I) of compound claim 16.
US 12,409,158 B2 teaches a method of treating cancer comprising administering a chemotherapy agent and a pharmaceutical composition of a benzensulfonamide derivative chosen from a list of diagramed compounds which explicitly includes a compound encompassed by the Markush group of Formula (I) of instant claim 16 (column 33, line 10 (i.e. the 2nd diagramed compound)).
As can be seen from the outlines above, the subject matter of the claim sets are related, essentially, in a genus/species fashion. That is, the instant claim set is a broader teaching (comprising Markush group of Formula (I)) than the narrower teaching of the patented claim (comprising a diagramed member of the Markush group of instant formula (I) and a chemotherapy agent). Note, however, that if a generic claim is presented in a separate application after the issuance of a patent claiming one or more species within the scope of the generic claim, the generic claim may be rejected on the grounds of nonstatutory double patenting. (MPEP 806.04(i).)
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,409,158 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Inventor teaches a method of treating cancer comprising administering a pharmaceutical composition of a benzensulfonamide derivative selected from the Markush group of compounds of Formula (I) of compound claim 15.
US 12,409,158 B2 teaches a method of treating cancer comprising administering a chemotherapy agent and a pharmaceutical composition of a benzensulfonamide derivative chosen from a list of diagramed compounds which explicitly includes compounds encompassed by the Markush group of Formula (I) of instant claim 15 (column 31, line 50 (i.e. the 9th diagramed compound); column 33, lines 10 and 25 (i.e. the 2nd and 5th diagramed compounds).
As can be seen from the outlines above, the subject matter of the claim sets are related, essentially, in a genus/species fashion. That is, the instant claim set is a broader teaching (comprising a Markush group of Formula (I)) than the narrower teaching of the patented claim (comprising diagramed members of the Markush group of instant formula (I) and a chemotherapy agent). Note, however, that if a generic claim is presented in a separate application after the issuance of a patent claiming one or more species within the scope of the generic claim, the generic claim may be rejected on the grounds of nonstatutory double patenting. (MPEP 806.04(i).)
Allowable Subject Matter
Claims 3, 9-11, 15, 16 and 19-21 are allowed. The following is a statement of reasons for the indication of allowable subject matter:
The key to the instant invention are the diagramed compounds of independent composition claim 3, and the Markush groups of independent composition claim 15 and independent compound claim 16. The closest prior art is the prior art of record. During the course of prosecution, inventor has narrowed the scope of the claimed subject matter such that it no longer reads on the cited art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EST.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 2/11/2026