DETAILED ACTION
Claims 32-41, 43, 53, 55 and 63-66, submitted 06 June 2024, are pending in the application and subject to examination in the instant Office 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 .
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 32-33 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30, 33 and 36 of U.S. Patent No. 12,570,752 B2, henceforth known as USPN ‘752.
Although the claims at issue are not identical, they are not patentably distinct from each other because independent claim 1 of USPN ‘752 is drawn to the use of nirogacestat in the treatment of a cancer which is patentable indistinct from the method taught by the instant application.
Claim 1 of USPN ‘752 teaches a method of treating a BCMA-expressing cancer in a subject by administering a composition comprising belantamab mafodotin and nirogacestat. Claim 3 of USPN ‘752 teaches wherein the nirogacestat is administered at a dose of at least about 50 mg, 100 mg, 150 mg or 200 mg. Finally, claim 6 teaches wherein the cancer is multiple myeloma.
When taken together, the claims of USPN ‘752 anticipate the method of the instant application which claims the treatment of multiple myeloma comprising administration of 200 mg per day of nirogacestat, 100 mg per day of nirogacestat, and 150 mg per day of nirogacestate as claimed in instant claims 32-33 and 43.
While USPN ‘752 teaches the combination of nirogacestat dihydrobromide and belantamab mafodotin, and the instant application is drawn to monotherapy with nirogacestat dihydrobromide, the open-ended transitional phrase “comprising” does not exclude additional composition components. Consequently, USPN ‘752 reads on the limitations of the instantly claimed invention.
Claims 32-41, 43, 53, 55 and 63-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 16, 22-24, 33 and 41-42 of copending Application No. 17/906,089 (PG PUB US 2023/0121547 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because copending application ‘089 is drawn to the use of nirogacestat in the treatment of a cancer which is patentable indistinct from the method taught by the instant application.
Specifically, claim 1 of copending application ‘089 is drawn to the treatment of cancer in a subject by administering nirogacestat dihydrobromide and a BCMA-directed therapy. Claims 4 and 5 teach wherein the hematologic cancer is multiple myeloma. Claim 16 teaches a dose of nirogacestat dihydrobromide in a range of 20 mg to 220 mg once or twice daily and claims 22-24 teach wherein the nirogacestat dihydrobromide is administered at a total daily dose of 200 mg, 150 mg and 100 mg, respectively. Claim 33 teaches wherein the nirogacestat dihydrobromide is administered orally and claim 41 recites that the nirogacestat dihydrobromide is administered in a tablet form. Finally, claim 42 teaches wherein the subject is human.
When taken together, these claims anticipate the method of the instant application which claim a method of treating multiple myeloma comprising administration of nirogacestat dihydrobromide in a dose of 100 mg per day, 200 mg per day, or 150 mg per day (instant claims 32, 33, and 43). Additionally, these claims anticipate the method wherein nirogacestat is in its dihydrobromide salt form (instant claims 34-35) and wherein the patient is human (instant claim 36). Copending application ‘089 also anticipates wherein the nirogacestat is administered orally in a tablet form (instant claims 37-39). Finally, copending application ‘089 anticipates wherein the nirogacestat is administered once or twice daily (instant claims 40-41).
Copending application ‘089 does not explicitly state the mean maximum drug plasma concentration of more than 225 ng/ml, as found in instant claims 53 and 64, and the mean maximum drug plasma concentration of more than 100 ng/ml, as found in instant claim 63. However, since the administered dose of nirogacestat dihydrobromide is identical to that of copending application ‘089, then it would follow that the mean maximum drug plasma concentration is within a similar range. Further, the same would apply to the measured area under the plasma curve of less than 3000 ng h/ml, as found in instant claims 55 and 66, and for when the measured area under the plasma curve is less than 700 ng h/ml, as found in instant claim 65.
While copending application ‘089 teaches the combination of nirogacestat dihydrobromide and a BCMA-directed therapy, and the instant application is drawn to monotherapy with nirogacestat dihydrobromide, the open-ended transitional phrase “comprising” does not exclude additional composition components. Consequently, copending application ‘089 reads on the limitations of the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 34-35, 36 and 63-64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 27-28 and 40 of copending Application No. 18/993,488 (PG PUB US 2026/0027084 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because copending application ‘488 is drawn to the use of nirogacestat in the treatment of multiple myeloma which is patentable indistinct from the method taught by the instant application.
Independent claim 21 of copending application ‘488 is identical to that of instant claim 63 with the exception that claim 21 of ‘488 recites “wherein the oral dosage provides a mean maximum drug plasma concentration (Cmax) of more than 225 ng/ml”. Instant claim 63 recites “wherein the oral dosage provides a mean maximum drug plasma concentration (Cmax-) of more than 100 ng/ml”. Claim 63 is further limited to a Cmax of more than 225 ng/ml in instant claim 64. Thus, ‘488 teaches an identical method for the treatment of multiple myeloma.
Claims 27 and 28 of ‘488 anticipate the use of nirogacestat in its hydrobromide form and its dihydrobromide form similar to that of instant claims 34-35.
Claim 40 of ‘488 anticipates instant claim 36 as both claims are drawn to wherein the patient is human.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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