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 .
DETAILED ACTION
Status of 17/906,089
Claims 1, 4-7, 16, 22-29, 31, 33-42, and 82 are currently pending.
Priority
Instant application 17/906,089, filed 9/12/2022, claims priority as follows:
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Support for the instant claims is provided in the provisional application, and thus, the instant claims are granted the effective filing date of 3/13/2020.
Information Disclosure Statement
All references from the IDS’s submitted on 3/28/2023, 5/18/2025, 7/22/2025, 9/16/2025, and 2/17/2026 have been considered unless marked with a strikethrough. The references struck through in the IDS of 2/17/2026 were not considered because there are no English translations.
Response to Applicants Arguments/Amendments
The amendment filed 12/11/2025 has been entered. Claims 1, 7, 16, 22-27, 29, 33, and 41 have been amended. Claim 82 has been added, but is not considered new matter.
Claims 16 and 22-26 were rejected in the Non-Final dated 9/26/2025 under 35 U.S.C. 112(b). In response, Applicant has amended the claims to omit the term “about” in order to overcome the rejection. The rejection is withdrawn.
In the Non-Final dated 9/26/2025, claims 1, 4-5, 27, 33-34, 37, and 40 were rejected under 35 U.S.C. 102(a)(1) and 102(a)(2). In response, Applicant amended the instant claims to recite the dihydrobromide salt of nirogacestat and specified the XRPD pattern of the crystal. Though the reference Novartis discloses hydrobromide/bromide as suitable acid addition salts (col 4), the XRPD pattern recited in the instant claims is not taught by Novartis. Thus, the rejection of claims 1, 4-5, 27, 33-34, 37, and 40 under 35 U.S.C. 102(a)(1) and 102(a)(2) was overcome and withdrawn.
Claims 16, 22-26, and 42 were rejected under 35 U.S.C. 103 in the Non-Final dated 9/26/2025. Upon amendment to the instant claims to recite the dihydrobromide salt of nirogacestat and specified the XRPD pattern of the crystal, the rejection has been overcome and withdrawn. and the arguments are deemed persuasive
In the Non-Final Rejection dated 9/26/2025, claims 1, 4-5, 16, 22-26, 33-34, 37, 40, 42 were rejected on the ground(s) of nonstatutory double patenting. In response, Applicant has amended the instant claims to recite the XRPD pattern of nirogacestat dihydrobromide and has argued that the references U.S. Patent No. 12,186,305, U.S. Patent App. No. 18/694,483, and U.S. Patent App. No. 18/736,140 are not available as reference patents or applications against the pending application in view of Baurin. However, that case is not yet precedential as of 3/20/2026, but may change in the future. Though the arguments are not considered persuasive, the claims are amended to recite the XRPD pattern of the polymorph of nirogacestat dihydrobromide, which overcomes the rejections of U.S. Patent No. 12,186,305, U.S. Patent App. No. 18/694,483, U.S. Patent App. No. 18/736,140, and U..S. Patent App. No. 17/602,434. Thus, the rejections are withdrawn. Additionally, the Examiner notes MPEP § 804(I)(B)(1)(b)(i), which states that the Examiner will only withdraw the provisional nonstatutory double patenting rejections in an application having the earlier patent term filing date until it is the only rejection remaining.
However, Applicants amendments to the instant claims have presented new ground(s) of rejection in this Office Action.
Election/Restriction
Applicant’s election of a hematologic cancer as the single disclosed species of disease to treat, an immunotherapy as the single disclosed species of B-cell maturation antigen directed therapy, and a dose of 20-220 mg once or twice daily as the single disclosed species of dosage amount and schedule in the reply filed 7/22/2025 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched in the Non-Final of 9/26/2025 and prior art was identified. In response, Applicant amended the instant claims to recite nirogacestat dihydrobromide and include the XRPD pattern with peaks at 8.8 ± 0.2, 9.8 ± 0.2, and 23.3 ± 0.2 degrees two theta to overcome the rejections of the Non-Final dated 9/26/2025. Subsequent search in this Office Action is based on the elected species including these features. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1, 4-5, 16, 22-27, 33-34, 37, 40, 42, and 82 read on the elected species. Claims 6-7, 28-29, 31, 35-36, 38-39, and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
Claim Interpretation
Claims 1 and 29 recite the phrase, “effective amount” in reference to the amount of nirogacestat administered to the subject. The instant specification defines the term as an amount of compound as described herein effective to achieve a particular biological result (page 8, para [0045]) and does not provide any examples of dosages provided to treat a disease in a subject. The definition does not make clear what the “particular biological result” is. In the broadest reasonable interpretation, the “particular biological result” is “treating cancer in a subject”. Therefore, any result that meets the definition of “treating”, in the context of any cancer, could be considered a “particular biological result”. The term “treating” is then defined in the specification as a therapeutic measure to cure, slow down, lessen symptoms of, and/or halt profession of a diagnosed pathologic condition or disorder. Further examples, such as reducing the number of cancer cells and increased progression-free, disease-free, metastasis-free, and overall survival are provided in the paragraph. Therefore, the term “effective amount” is currently being interpreted as any amount provided to a subject to induce one of the examples provided above, in lieu of exemplary dosages or working examples.
NEW REJECTIONS NECESSITATED BY AMENDMENT
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-5, 16, 22-27, 33-34, 37, 40, 42 and 82 are rejected under 35 U.S.C. 103 as being unpatentable over Novartis AG (WO 2018/201051 A1, cited in the IDS of 3/28/2023, herein after “Novartis”) in view of Pfizer Inc. (WO 2021/029854 A1, cited in the IDS of 3/28/2023, herein after “Pfizer”) and in further view of Kummar (Kummar, S. et. al. J. Clin. Oncol. 2017 May 10;35(14):1561-1569). The Examiner notes though the international publication date of Pfizer is after the effective filing date of the instant claims, Pfizer does qualify as 102(a)(2) art as the international filing date is August 9th, 2019, which is before the effective filing date of the instant claims. Additionally, this rejection applies to the elected species.
Determining the scope and contents of the prior art
Regarding claims 1, 4-5, 34, 37, and 40 the reference Novartis discloses compositions and methods for treating diseases associated with expression of B-cell maturation antigen (BCMA) (abstract). Specifically, Novartis discloses the combination of nirogacestat and BCMA-directed immunotherapy/CD3 bispecific antibody FP31 to kill the human multiple myeloma cell line KMS11 (page 25, lines 12-17 and Figure 9A). The antibody disclosed by Novartis falls under the broadest reasonable interpretation of “immunotherapy” and a “bispecific antibody therapy” recited in the instant claims.
With respect to claims 27 and 82, Novartis teaches that the BCMA-targeting agent and nirogacestat can be administered simultaneously or sequentially, regardless of the order (page 19, lines 31-35).
With respect to claim 33, Novartis discloses that the BCMA-targeting agent and the GSI are present in a single dose form, or as two or more dose forms (page 22, lines 20-21). The definition of dose forms disclosed by Novartis includes oral, intravenous, and subcutaneous administration to the subject (page 150, lines 7-14).
The reference Pfizer teaches the crystalline Form A of nirogacestat, which is characterized by an XRPD patten having peaks at 8.8 ± 0.2, 9.8 ± 0.2, and 23.3 ± 0.2 degrees two theta (page 2, para [0007]). Further, Pfizer teaches crystalline Form A may be administered to treat a subject with tumors or cancer, including hematological cancers such as multiple myeloma and T-cell acute lymphoblastic leukemia (page 68, para [0326]).
The reference Kummar teaches nirogacestat to treat tumors in a 150 mg oral dosage twice a day (abstract) in humans.
Ascertaining the differences between the prior art and the claims at issue
Novartis fails to teach the XRPD pattern of nirogacestat dihydrobromide and the dosage limitations, whereas Pfizer fails to teach the combination of nirogacestat dihydrobromide and a (BCMA)-directed therapy. Kummar fails to teach the XRPD pattern of nirogacestat dihydrobromide and the combination of nirogacestat dihydrobromide with a B-cell maturation antigen (BCMA)-directed therapy.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of methods of treatment comprising combination therapies with nirogacestat and a BCMA-directed therapy. An artisan possess the technical knowledge necessary to make adjustments to the combination therapies to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said methods of treatment comprising combination therapies with nirogacestat and a BCMA-directed therapy and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious to combine the treatment methods of Novartis with the crystalline form of nirogacestat dihydrobromide of Pfizer and the dosage limitations of Kummar to arrive at the limitations of the instant claims because the references teach the treatment of human cancer with nirogacestat. Further, a skilled artisan would have been motivated before the effective filing date to combine the methods of treatment with the crystalline form of nirogacestat dihydrobromide and the dosage limitations taught by Novartis, Pfizer, and Kummar to identify additional methods of treating cancers, and would have readily predicted that the combination of the references would improve known treatment methods. Since this modification of the prior art represents nothing more than the “predictable use of prior art elements according to their established functions”, a prima facie case of obviousness exists.
Additionally, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the daily dosages of nirogacestat dihydrobromide recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the dosages of nirogacestat dihydrobromide of the formulation to provide optimal treatment conditions. The dosage of nirogacestat dihydrobromide in the combination therapy is a result effective parameter that will affect the physical properties of the final treatment formulation. The amount of nirogacestat dihydrobromide in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize, as is the amount of BCMA-directed therapy. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the nirogacestat dosage disclosed by Kummar provides a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal dosage of nirogacestat dihydrobromide to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the dosage of nirogacestat in the formulation and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
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 1, 4-5, 16, and 22-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-5, 7, 11 of U.S. Patent No. 12,186,305 (herein after the ‘305 patent) and in further view of Pfizer Inc. (WO 2021/029854 A1, cited in the IDS of 3/28/2023, herein after “Pfizer”). As stated above, the reference Pfizer qualifies as 102(a)(2) art.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘305 patent recite a method of treating multiple myeloma with nirogacestat and one or more additional active ingredients, of which a BCMA-directed therapy is, for treating multiple myeloma, wherein the method comprises orally administering 150 or 100 mgs of nirogacestat twice a day. Additionally, though the ‘305 patent does not recite nirogacestat dihydrobromide with the XRPD pattern of the instant claims, the reference Pfizer does, and applying KSR prong (B), it would have been prima facie obvious for a skilled artisan to substitute nirogacestat of the ‘305 patent with nirogacestat dihydrobromide with the XRPD pattern of 8.8 ± 0.2, 9.8 ± 0.2, and 23.3 ± 0.2 degrees two theta because the compounds are known for the same purpose and are thus, expected to have similar properties and results.
Additionally, though the ‘305 patent does not teach the full scope of nirogacestat dihydrobromide dosages of the instant claims, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the daily dosages of nirogacestat dihydrobromide recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the dosages of nirogacestat dihydrobromide of the formulation to provide optimal treatment conditions. The dosage of nirogacestat dihydrobromide in the combination therapy is a result effective parameter that will affect the physical properties of the final treatment formulation. The amount of nirogacestat dihydrobromide in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize, as is the amount of BCMA-directed therapy. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the nirogacestat dosages disclosed by the ‘305 patent provides a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal dosage of nirogacestat dihydrobromide to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the dosage of nirogacestat in the formulation and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Claims 1, 4-5, 16, 22-26, 34 and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30, 33, 34, 36, 43, and 46 of copending Application No. 17/602,434 (herein after the ‘434 application) as evidenced by Watson (Watson, E. C. R. EJHaem, 2025, 6(3) e70039) and in further view of Pfizer Inc. (WO 2021/029854 A1, cited in the IDS of 3/28/2023, herein after “Pfizer”). As stated above, the reference Pfizer qualifies as 102(a)(2) art.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘434 application recite a method of treating a BCMA-expressing cancer, of which multiple myeloma is, with belantamab mafodotin and nirogacestat. The reference Watson discloses belantamab mafodotin as an immunotherapy for treatment in multiple myeloma (abstract), thus qualifying belantamab mafodotin as an immunotherapy under the broadest reasonable interpretation of the instant claims. Additionally, though the ‘434 application does not recite nirogacestat dihydrobromide with the XRPD pattern of the instant claims, the reference Pfizer does, and applying KSR prong (B), it would have been prima facie obvious for a skilled artisan to substitute nirogacestat of the ‘434 application with nirogacestat dihydrobromide with the XRPD pattern of 8.8 ± 0.2, 9.8 ± 0.2, and 23.3 ± 0.2 degrees two theta because the compounds are known for the same purpose and are thus, expected to have similar properties and results.
Additionally, though the ‘434 application does not teach the full scope of nirogacestat dihydrobromide dosages of the instant claims, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the daily dosages of nirogacestat dihydrobromide recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the dosages of nirogacestat dihydrobromide of the formulation to provide optimal treatment conditions. The dosage of nirogacestat dihydrobromide in the combination therapy is a result effective parameter that will affect the physical properties of the final treatment formulation. The amount of nirogacestat dihydrobromide in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize, as is the amount of BCMA-directed therapy. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the nirogacestat dosages disclosed by the ‘434 application provides a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal dosage of nirogacestat dihydrobromide to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the dosage of nirogacestat in the formulation and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4-5, 16, 22-26, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 61, and 68 of copending Application No. 18/694,483 (herein after the ‘483 application) in further view of Pfizer Inc. (WO 2021/029854 A1, cited in the IDS of 3/28/2023, herein after “Pfizer”). As stated above, the reference Pfizer qualifies as 102(a)(2) art.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘483 application recite a method of treating multiple myeloma with a BCMA antibody, or antigen-binding fragment thereof, and nirogacestat. Though the ‘483 application does not teach nirogacestat dihydrobromide with the XRPD pattern of 8.8 ± 0.2, 9.8 ± 0.2, and 23.3 ± 0.2 degrees two theta, the reference Pfizer does, and applying KSR prong (B), it would have been prima facie obvious for a skilled artisan to substitute the nirogacestat of the ‘483 application with the nirogacestat dihydrobromide of Pfizer to arrive at the instant claims because both compounds are known for the same purpose and are thus, expected to have similar properties and results.
Furthermore, though the ‘483 application does not teach the same scope of nirogacestat dihydrobromide dosages as the instant claims, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the daily dosages of nirogacestat dihydrobromide recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the dosages of nirogacestat dihydrobromide of the formulation to provide optimal treatment conditions. The dosage of nirogacestat dihydrobromide in the combination therapy is a result effective parameter that will affect the physical properties of the final treatment formulation. The amount of nirogacestat dihydrobromide in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize, as is the amount of BCMA-directed therapy. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the nirogacestat dosage disclosed by the ‘483 application provides a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal dosage of nirogacestat dihydrobromide to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the dosage of nirogacestat in the formulation and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4-5, 16, 22-26, 33, 34, 37, 40, and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-37, 40-41, and 43 of copending Application No. 18/736,140 (herein after the ‘140 application) in further view of Novartis AG (WO 2018/201051 A1, cited in the IDS of 3/28/2023, herein after “Novartis”) and Pfizer Inc. (WO 2021/029854 A1, cited in the IDS of 3/28/2023, herein after “Pfizer”). As stated above, the reference Pfizer qualifies as 102(a)(2) art.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘140 application recite a method for treating multiple myeloma comprising administering nirogacestat or a pharmaceutically acceptable salt thereof. Though the ‘140 application fails to teach the addition of a BCMA-directed immunotherapy and nirogacestat dihydrobromide with an XRPD pattern of 8.8 ± 0.2, 9.8 ± 0.2, and 23.3 ± 0.2 degrees two theta, the references Novartis and Pfizer teach those limitations.
Applying KSR prong (A), it would have been prima facie obvious to combine the treatment methods the ‘140 application with the BCMA-directed immunotherapy of Novartis and the nirogacestat dihydrobromide with the XRPD pattern of 8.8 ± 0.2, 9.8 ± 0.2, and 23.3 ± 0.2 degrees two theta to arrive at the limitations of the instant claims because the references teach the treatment of human cancer with nirogacestat. Further, a skilled artisan would have been motivated before the effective filing date to combine the methods of treatment of the ‘140 application with the BCMA-directed therapy of Novartis and the nirogacestat dihydrobromide of Pfizer to identify additional methods of treating cancers, and would have readily predicted that the combination of the references would improve known treatment methods. Since this modification of the prior art represents nothing more than the “predictable use of prior art elements according to their established functions”, a prima facie case of obviousness exists.
Additionally, though the ‘140 application does not teach the full scope of nirogacestat dihydrobromide dosages of the instant claims, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the daily dosages of nirogacestat dihydrobromide recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the dosages of nirogacestat dihydrobromide of the formulation to provide optimal treatment conditions. The dosage of nirogacestat dihydrobromide in the combination therapy is a result effective parameter that will affect the physical properties of the final treatment formulation. The amount of nirogacestat dihydrobromide in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize, as is the amount of BCMA-directed therapy. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the nirogacestat dosages disclosed by the ‘140 application provides a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal dosage of nirogacestat dihydrobromide to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the dosage of nirogacestat in the formulation and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1, 4-5, 16, 22-27, 33-34, 37, 40, 42, and 82 are rejected. Claims 6-7, 28-29, 31, 35-36, 38-39, and 41 are withdrawn.
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 Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621