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
Claims 1, 11, 14, 21, 25-26, 28, 35 and 41-45 are canceled. Claims 2, 5, 7, 9, 17-19, 30, 32, 47-48, 50-52, 55 and 57 are amended. Claims 60-63 are added, no new matter was added. Claims 2, 5, 7, 9, 17-19, 30, 32, 47-48, 50-52, 55-57 and 60-63 are pending and are now evaluated on its merits.
Priority
This application claims domestic benefit to U.S. provisional application 63/196,744, dated 06/04/2021.
Information Disclosure Statement
The information disclosure statement (IDS) dated 08/05/2026 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Response to Arguments
Applicant’s arguments, see Page 1, filed 04/21/2026, with respect to the 103 rejections of claims 1-2, 5, 7, 9, 11, 21, 25-26, 28, 41-45, 47-48, 50-52 and 55-57 under Woods et al. (US Patent No. 9718821) have been fully considered and are persuasive by the cancelation and amendment to the above claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of O’Dowd et al. (US Patent No. 9714244).
Applicant have additionally overcome the 112b rejection of claims 17, 25, 35 and 57 by the amendment to claims 17 and 57 and the cancelation of claims 25 and 35.
The teachings of O’Dowd of a method for the treatment of breast cancer, lung cancer, prostate cancer, brain cancer and leukemia comprising administration of pharmaceutical composition of a Wee1 kinase inhibitor of Formula (I)
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in combination with a chemotherapeutic read to the claimed invention to treat cancer comprising compound Formula II with its limitations.
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.
Claims 30 and 32 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.
Regarding claim 30, the phrase " R6 ", renders the claim indefinite because it is unclear what is/are the limitation(s) for R6. The claim fails to recite the limitation(s) of R6. Ultimately, the metes and bounds of the claim are unclear.
Regarding claim 32, the phrase " R2 " renders the claim indefinite because it is unclear what is/are the limitation(s) for R2. The claim fails to recite the limitation(s) of R2. Ultimately, the metes and bounds of the claim are unclear.
Regarding claims 30 and 32, the phrase "Formula VIa" renders the claim indefinite because it is unclear which claim is of Formula VIa. Both claims convey the same formula but are of different chemical structures.
Claim Rejections - 35 USC § 103
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.
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.
Claims 2, 5, 7, 9, 17-19, 47-48, 50-52, 55-57 and 60-63 are rejected under 35 U.S.C. 103 as being unpatentable over O’Dowd et al. (U.S. Patent No. 9714244).
Regarding claims 2, 5, 7, 9, 17-19, 47-48, 50-52, 55-57 and 61-62, O’Dowd teaches a method for the treatment of breast cancer, lung cancer, prostate cancer, brain cancer, ovarian cancer, melanoma, non-Hodgkin's lymphoma and leukemia comprising administration of pharmaceutical composition of a Wee1 kinase inhibitor of Formula (I)
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in combination with a chemotherapeutic selected from erlotinib, gefitinib, dasatinib, sunitinib, cisplatin and a pharmaceutical acceptable excipient (relevant to claims 47-48, 50-52, 55 and 61-62) (Pg. 11, para. 8-10; Pg. 12, para. 4-5). The compounds taught by O’Dowd were carried out as in vitro testing on human genes (relevant to claim 56) (Pg. 22, 1st para.) and in vivo pro-drug (relevant to claim 57) (Pg 10, 5th para.).
Of the above Formula (I) R1 is a substituted aryl or heteroaryl group, R2 is a hydrogen atom, a methyl group, a bromo group, or a substituted amido or C3-alkynyl group and R3 is an optionally substituted aryl, alkyl, alkenyl, alkynyl, cycloalkyl, cycloalkenyl or heterocyclyl group, wherein the heterocyclyl group contains 1 or more heteroatoms selected from the group consisting of nitrogen and oxygen atoms (Pg. 12-13). Heterocyclyl as defined by O’Dowd may be a single ring compound selected from pyrrolyl, pyrrolinyl, pyrrolidinyl, imidazolyl, imidazolinyl, imidazolidinyl, pyrazolyl, pyrazolinyl, pyrazolidinyl, triazolyl, tetrazolyl, oxazolyl, oxazolidinyl, isoxazolidinyl, isoxazolyl, thiazolyl, isothiazolyl, thiazolinyl, isothiazolinyl, thiazolidinyl, isothiazolidinyl, thiodiazolyl and oxadiazolyl (Pg. 7, para. 4).
O’Dowd in particular embodiments teach R3 as
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wherein R4e is selected from H, alkanoyl group, C1-C6 alkyl and C2-C6 alkenyl, R1 as
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wherein R1a and R1b is each H, halogen, hydroxyl, cyano or amino and compounds
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(example 2),
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(example 9) and
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(example 10).
In terms of claims 60 and 63, the limitations of glioblastoma and cutaneous T-Cell lymphoma merely further limit the type of brain cancer and T-Cell lymphoma but fails to claim the cancer being treated is the specific category being recited; thus, the teachings of O’Dowd read to the limitations of the claims.
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have developed compounds
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and
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to treat Wee1 associated cancers. One would have been motivated to do so from the teachings of O’Dowd of the treatment of Wee1 associated cancers comprising compounds
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,
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and
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wherein the embodiment R3 of a substituted phenyl is replaced with a heterocyclic of pyrazole. There is a reasonable expectation of developing compounds
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and
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to treat Wee1 associated cancers from the teaching of O’Dowd.
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 2, 17-19, 47-48, 50-52, 55-56 and 60-63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 6-18 of copending Application No. 19/441,544 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2 and 6-18 of copending ‘544 anticipates claims 2, 17-19, 47-48, 50-52, 55-56 and 60-63 of claimed invention of the treatment of a Wee1 associated cancer comprising the administration of compound
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and a chemotherapeutic agent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
