DETAILED ACTION
The amendment submitted on November 20, 2025 has been entered. Claims 155-172 are pending in the application. Claims 165-172 are withdrawn. Claims 155-164 are rejected for the reasons set forth below. No claim is allowed.
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 . 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.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a method of treating lung cancer with cisplatin and compound A-3, in the reply filed on November 20, 2025 is acknowl-edged. Claims 165-172 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 20, 2025.
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.
Claims 155-164 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0163000 A1 by Ahmad et al.
Ahmad (cited in applicant’s IDS1) discloses compound A-3. See compound I-C-79 in the reference at p. 62. The compounds disclosed in the reference “are very potent ATR inhibitors” and “show surprising synergy with other cancer agents, such as cisplatin” (para. 0009), which suggests a combination therapy of compound A-3 with cisplatin. Ahmad further discloses using this compound in a method of treating non-small cell lung cancer (para. 0239), which meets the limitations of claims 156 and 161. The reference also discloses treating cancer “having defects in the ATM signaling cascade,” including p532 (para. 0327), which meets the limitations of claims 157-158 and 162-163.
The difference between the prior art and the claims at issue is that Ahmad does not specifically disclose the time limitations of the instant claims. To wit, the reference does not specifically disclose administering compound A-3 at a time period 12-24 hours after the cisplatin (claims 155 and 160), such as 16 hours afterwards (claims 159 and 164), or administering a second dosage one week later (claim 160). This subject matter, however, would have been prima facie obvious when the teachings of the reference are considered as a whole.
With respect to the timing and frequency of administration, the reference generally discloses (para. 0308):
The desired dosage can be delivered three times a day, two times a day, once a day, every other day, every third day, every week, every two weeks, every three weeks, or every four weeks. In certain embodiments, the desired dosage can be delivered using multiple administrations (e.g., two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, or more administrations).
Ahmad discloses example time periods of “20 hours and about 28 hours (e.g., about 24 hours or 24 hours±2 hours” between administering cisplatin and the ATR inhibitor (para. 0267), as well as “a second dose of the ATR inhibitor between about 6 days and about 8 days (e.g., on day 9) after the first dose” (para. 0273). The reference further discloses that figuring out an effective treat-ment protocol would have been a matter of routine experimentation for “those of ordinary skill in the art” (para. 0305). Ahmad even provides Examples showing how to optimize the dose schedule (see Example 1 and Example 2 at para. 0314-20). The examiner therefore concludes that one would have viewed the subject matter of the instant claims as being a matter of optimi-zation within the general teachings of the cited reference and, accordingly, prima facie obvious. See MPEP 2144.05(II)(A) (Optimization Within Prior Art Conditions or Through Routine Experi-mentation).
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 possi-ble 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 provi-sions 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 accompa-nied 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 155-164 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,670,215 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘215 Patent claims compound A-3. The specification of the ‘215 Patent explains that this compound is useful in treating non-small cell lung cancer (col. 27, ll. 20-25). It also explains that it is “effective for sensitizing cancer cells to Cisplatin” (col. 32, ll. 45-50), which would have suggested a combination therapy of compound A-3 with cisplatin. The time limitations of the instant claims are prima facie obvious for substantially the same reasons discussed in detail above.
Claims 155-164 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 82 of U.S. Patent No. 9,650,381 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 82 of the ‘381 Patent is directed to compound A-3. The specification of the ‘381 Patent explains that this compound is useful for treating non-small cell lung cancer (col. 180, ll. 50-57) and that it is synergistic with cisplatin (col. 2, ll. 25-30). As explained above, the time limitations of the instant claims are prima facie obvious.
Claims 155-164 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,787,452 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above.
Claims 155-164 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,187,731 B2 for substantially the same reasons discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The examiner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interview practice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organ-ization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
January 8, 2026
1 See the information disclosure statement (IDS) submitted on August 18, 2022.
2 It is well known that the p53 referred to in Ahmad is the tumor protein, and TP53 is the gene that codes for it.