DETAILED 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 .
Election/Restrictions
Applicant's election without traverse of Group I (claims 37 (in part) and 38-40) in the reply filed on 03/30/2026 is acknowledged. Applicant further argued that Group VI (claims 59-66) should be examined together with claims of Group I since the claims are narrowing the scope of the independent claim 37. The arguments were found persuasive and consequently, claims 37 (as drawn to treatment of colon cancer), 38-40 and 59-66 are examined. Claims 37-67 are pending; claims 41-58 and 67 are withdrawn from prosecution for being drawn to non-elected subject matter.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 37, 38 and 59-65 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshida et al. (WO2018008711 -cited by Applicant).
The reference discloses an EP4 antagonist compound represented by general formula (I) ( corresponding to the "compound represented by general formula (I)" of the present application) or a salt thereof that is used for treating cancer(colon cancer, inter alia) in combination with checkpoint inhibitors (claim 11-20, [234], examples, etc.). The compounds are typically formulated with various additives or pharmaceutically acceptable carriers such as solvents, and then administered systemically or topically, orally or parenterally ([0221]). The dosage of the compound used varies depending on age, weight, symptoms, therapeutic effect, administration method, processing time, etc., but is usually administered orally once to several times a day in a range of 1 ng to 1000 mg per adult, or parenterally once to several times a day in a range of 0.1 ng to 100 mg per adult, or continuously administered intravenously for a range of 1 to 24 hours per day ([0223]). The combination of the EP4 antagonist and checkpoint inhibitors may be used in combination with other drugs (e.g., known anticancer therapies) for (1) complementing and /or enhancing the therapeutic effect, (2) improving kinetics and absorption, reducing the dosage, and/or (3) reducing side effects ([0243])
The dosage of the compound used in this invention varies depending on age, weight, symptoms, therapeutic effect, administration method, processing time, etc., but is usually administered orally once to several times a day in a range of 1 ng to 1000 mg per adult, or parenterally once to several times a day in a range of 0.1 ng to 100 mg per adult, or continuously administered intravenously for a range of 1 to 24 hours per day.
The immune checkpoint inhibitors disclosed include anti-PD-1 antibodies such as nivolumab, anti-PD-L1 antibodies, anti-CTLA-4 antibodies ([0227]).
Thus, in the broadest reasonable interpretation, claims 37, 38, 59 and 60 are anticipated by the reference cited.
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.
Claims 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over
Yoshida et al. (WO2018008711 -cited by Applicant) in view of Chen et al. (Neoadjuvant therapy of bevacizumab in combination with oxaliplatin and capecitabine (XELOX) for patients with metastatic colorectal cancer with unresectable liver metastases: a phase II, open-label, single-arm, noncomparative trial. Asia-Pacific J. Clin. Oncol. 14, 61-68, 2018).
The teaching of Yoshida et al. were presented supra and they were silent about using bevacizumab+XELOX for treating colon cancer.
Chen et al. disclosed neoadjuvant therapy with bevacizumab plus XELOX (capecitabine and oxaliplatin) for untreated metastatic colorectal cancer. Patients received bevacizumab 5 mg/kg and oxaliplatin 85 mg/m2 on day 1, and capecitabine 1000 mg/m2 twice daily on days 1–5 followed by 2 days of rest in a 14-day cycle
for 12 cycles. The neoadjuvant therapy with bevacizumab plus XELOX was well tolerated and effective in previously untreated metastatic colorectal cancer patients with initially unresectable liver metastases phase II, open-label study evaluated the efficacy and safety of neoadjuvant therapy with bevacizumab plus XELOX (capecitabine and oxaliplatin) for untreated metastatic colorectal cancer with unresectable liver metastases and assessed conversion of unresectable to resectable metastases after neoadjuvant treatment (Abstract).
It would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have used the well-known and efficient colon cancer treatment of Bevacizumab and XELOX of Chen et al. in the treatment of colon cancer of Yoshida ant treat colon cancer with a reasonable expectation of success. This is because the skilled artisan would have used tested methods existent in the art. Regarding the actual dosages claimed instantly, Yoshida et al. clearly indicated that the dosage and administration regimens could easily altered depending on the patient or disease 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 37-40, 59, 62 and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,065,226 in view of Chen et al. (cited supra).
The U.S. Patent teaches a method of treating cancer with an EP4 antagonist with the same structure as claimed instantly and an immune checkpoint inhibitor. The Patent does not teach adding a standard treatment to the treatment claimed. Chen et al. disclosed a known and efficient method of treating colon cancer with Bevacizumab and XELOX therapy.
It would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have used the well-known and efficient colon cancer treatment of Bevacizumab and XELOX of Chen et al. in the treatment of colon cancer of U.S. Patent No. 11,065,226 and treat colon cancer with a reasonable expectation of success. This is because the skilled artisan would have used tested methods existent in the art.
Conclusion
No claims are allowed.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
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