DETAILED ACTION
The amendment submitted on June 3, 2026 has been entered. Claims 155-172 are pend-ing in the application. Claims 165-172 are withdrawn. Claims 155-164 are rejected for the reasons set forth below. No claim is allowed.
This communication includes at least one new ground of rejection that was not necessi-tated by applicant’s amendment of the claims, so this Office action is non-final. See MPEP 706.07(a) (Final Rejection, When Proper on Second 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 . 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, is acknowledged. Claims 165-172 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Withdrawn Rejections
The rejection of claims 155-164 under 35 U.S.C. 103 as being unpatentable over US 2014/0163000 A1 by Ahmad et al. is withdrawn because the examiner finds applicant’s arguments concerning para. 0308, 0267, 0273, and 0314-20 of this reference to be persuasive. See appli-cant’s Remarks, submitted June 3, 2026, at pp. 6-7.
The rejections of claims 155-164 for double patenting over U.S. Patent Nos. 9,670,215 B2; 9,650,381 B2; 10,787,452 B2; and 12,187,731 B2 are likewise withdrawn.
New Grounds for Rejection 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 explained in MPEP 2141 et seq. They 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. in view of El-Kareh et al., Neoplasia 2003;5(2):161-69.
Ahmad (cited in the prior action) 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 p531 (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, especially in view of El-Kareh et al.
Ahmad discloses that Optimization of “the time of administration” and “the duration of the treatment” are both factors that factors that would have been “well known in the medical arts” (para. 0255):
the total daily usage of the compounds and compositions of the present invention will be decided by the attending physician within the scope of sound medical judgment. The specific effective dose level for any particular patient or organism will depend upon a variety of factors including the disorder being treated and the severity of the disorder; the activity of the specific compound employed; the specific composition employed; the age, body weight, general health, sex and diet of the patient; the time of administration, route of administration, and rate of excretion of the specific compound employed; the duration of the treatment; drugs used in combination or coincidental with the specific com-pound employed, and like factors well known in the medical arts.
See Ahmad at para. 0255. Ahmad further explains that “the dosing schedule of the compounds of the present invention may vary” (para. 0257), it being implicit that figuring out these parame-ters would have been a matter of routine experimentation for one of skill in the art.
El-Kareh et al. is cited as additional evidence that modelling the pharmacodynamics of cisplatin was known in the prior art. According to this reference, “[t]he optimization of the dosing and delivery schedule can potentially minimize adverse effects while maintaining efficacy” (p. 161). “Theoretical pharmacodynamic models that predict tumor cell survival for a given time course of drug exposure provide a rational basis for the optimization of administration schedules, which involves maximizing tumor cell kill” (p. 161). Exposure times of between 1 hour and 121 hours are described as examples (see Table 1 at p. 162). Note that the time limitations of the instant claims are within this general range suggested in Table 1 of El-Kareh. While this reference acknowledges that “further information about the relationship between plasma exposure and host toxicity” (p. 168), among other things, are needed, the reference nevertheless concludes that the pharmacodynamic principles described in the reference may form a “component of a rational strategy for determining the optimal dose and schedule of cisplatin administration” (p. 168). It is implicit in the teachings of the reference that determining such an optimal schedule of administration would have been a matter of routine experimentation.
It would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date to optimize the schedule of drug administration as taught by Ahmad and El-Kareh as described above and thereby arrive at the subject matter of the instant claims. One would have viewed the time limitations of the instant claims as being a matter of optimization within the general teachings of the cited references and, accordingly, prima facie obvious. See MPEP 2144.05(II)(A) (Optimization Within Prior Art Conditions or Through Routine Experimentation). One would have been motivated to do so in order to improve treatment efficacy. One would have had a reasonable expectation of success because Ahmad explains that figuring out this type of information would have been “well known in the medical arts” (see Ahmad at para. 0255). It is the examiner’s impression that Ahmad does not specifically disclose a time period of “about 12 and about 24 hours” (see instant claim 1) because it would not have been necessary for the reference to provide this much detail. Instead, it would have been apparent to one of skill in the art that this parameter could be determined 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 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 in view of El-Kareh et al. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘215 Patent (cited in the prior action) 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 limita-tions of the instant claims are prima facie obvious over El-Kareh et al. for substantially the same reasons discussed above, mutatis mutandis.
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 in view of El-Kareh et al. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 82 of the ‘381 Patent (cited in the prior action) 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 in view of El-Kareh et al. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. The ‘452 Patent was cited in the prior action.
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 in view of El-Kareh et al. for substantially the same reasons discussed above. The ‘731 Patent was cited in the prior action.
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 exam-iner 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/interviewpractice. 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 organization 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
August 25, 2026
1 It is well known that the p53 referred to in Ahmad is the tumor protein, and TP53 is the gene that codes for it.
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