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 .
Applicant's response to the previous Office action, dated November 10, 2025, has been received. By way of this submission, Applicant has amended claim 1, and cancelled claim 31.
Claims 1, 10, 13, 15, 32-36, 46-47, and 53 are pending in the application. Claims 13, 46-47, and 53 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed November 9, 2023.
Claims 1, 10, 15, and 32-36 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated May 8, 2025.
Claim Rejections - 35 USC § 112
Claims 31-32 were previously 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.
Applicant's amendments to the claims have addressed this issue, and this rejection is hereby withdrawn.
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.
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, 10, 15, 19 and 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Dong (WO2016014148A1) in view of Damstrup (Int J Rad Onco Bio Phys, 94.4: 940(2). Elsevier B.V. (Mar 15, 2016)) and Yoo (WO2016160792A1).
Applicant argues that the claimed invention exhibits unexpected results over the cited art, and therefore, the claimed combination of treatments is not obvious. Applicant further argues that there is no suggestion or motivation to combine the teachings of Dong, Damstrup, and Yoo and arrive at the present invention.
Applicant's arguments have been considered fully but are not found to be persuasive.
The simple substitution of one known element for another to obtain predictable results is one such rationale that may support a rationale of obviousness. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). To reject a claim based on this rationale, Office personnel must resolve the Graham factual inquiries. Then, Office personnel must articulate the following:
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
(2) a finding that the substituted components and their functions were known in the art;
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
MPEP 2143(1)(B).
In the instant case, Dong is explicit in teaching a method for treating a cancer patient, the method comprising administering to the patient a DNA-PKcs inhibitor and an anti-B7-H1 (i.e., anti-PD-L1) antibody (page 2, lines 22-25). Dong differs from the claimed invention by the use of the specifically recited DNA-PKcs inhibitor and anti-B7-H1 antibody.
As (S)-[2-chloro-4- fluoro-5-(7-morpholin-4-yl-quinazolin-4-yl)-phenyl]-(6-methoxypyridazin-3-yl)- methanol and avelumab were known in the art to be useful as a DNA-PK inhibitor (Damstrup) and an anti-PD-L1 antibody (Yoo), one of skill in the art could arrive at the claimed invention through simple substitution of the specific compounds taught by Damstrup and Yoo to perform the method of Dong, which relies on a generic DNA-PK inhibitor an anti-B7-H1 antibody. This is especially true since Damstrup and Yoo both teach that their respective compounds are useful in the treatment of colon cancer, and Dong also teaches the treatment of colon cancer.
With regards to Applicant's assertion of unexpected results, since Dong teaches a method for treating a cancer patient, comprising administering to the patient a DNA-PKcs inhibitor and an anti-B7-H1 antibody, this is at least a general expectation of some combination of benefits over monotherapy.
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). MPEP 2144.06(I).
With regards to the claimed dosage of radiotherapy, determination of dosage is routinely determined by the ordinary artisan as of the effective filing date of the claimed invention was known as result effective variables that depend on the conditions of the patients. It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). Furthermore, Yoo teaches that dosages may depend upon several factors, including previous or concurrent therapeutic interventions (para. 0182: "The practitioner responsible for administration will, in any event, determine the concentration of active ingredient(s) in a composition and appropriate dose(s) for the individual subject."). One of ordinary skill in the art would appreciate the amount or dosage of radiotherapy could be adjusted to achieve optimum therapeutic efficacy, especially given the guidance found in Yoo. Applicant has not demonstrated an unexpected criticality of the claimed radiotherapy dosage to rebut this argument. MPEP 2144.05.
As stated previously, Applicant's disclosure does not describe any experiments performed with compounds other than avelumab and M3814. The arguments presented by Applicant do not prove that there was no reasonable expectation of synergy between a generic DNA-PK inhibitor and a generic anti-PD-L1 antibody, nor that such a synergy is unexpected and unique to the two claimed compounds. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). MPEP 716.01(c). Absent such evidence, the method recited by Dong remains prejudicial to the instant claims.
This rejection is therefore maintained.
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, 10, 15 and 32-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 38, and 40 of copending Application No. 18/684,604 in view of Damstrup and Yoo.
Applicant wishes to defer addressing this rejection until patentable subject matter is found. As there is no patentable subject matter currently in the application, this rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Abutarif (US20100210700A1) teaches fractionated radiotherapy at a dosage of 60 Gy administered in 30 fractions for the treatment of cancer (para. 0026).
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 8:00 to 4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER JOHANSEN/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644