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 .
Priority
This application is a 371 of PCT/EP2023/053502 (02/13/2023)
and claims foreign priority to UNITED KINGDOM 2201935.0 (02/14/2022).
Drawings
The drawings filed 8/13/24 are objected to for not conforming to the requirements of 37 CFR 1.84(u)(1) (“View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.”). MPEP 608.02.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ikezoe et al. (Cancer Research, 64, p. 7426-7431 (2004)).
Ikezoe teaches the anticancer combination of ritonavir with docetaxel in vivo in drug resistant cancers (title, abstract, p. 7431). Thus, claims 1-5, 10-11 are anticipated.
Regarding claim 7, Ikezoe determined responsiveness to DU-145 cell lines (Abstract, p. 7429).
Regarding claim 8-9, Ikezoe teaches oral and IV administration (p. 7428: “Ritonavir (10 mg/kg/mouse) was administered five times a week orally. Docetaxel (25 mg/kg/mouse) was admin istered intravenously once a week.”).
Claims 1-5, 7-17, 54-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beijnen et al. (WO2020127607, publ 2020-06-25).
Beijnen teaches the anticancer combination of ritonavir with docetaxel in vivo in drug resistant cancers (Abstract, claim 11, 13-15). Thus, claims 1-5, 10-11 are anticipated.
Regarding claims 12-17, Beijnen teaches “ritonavir is administered in a weekly dosage in the range of 200-300 mg” (claim 14), “docetaxel is administered orally in a weekly dosage of 50 mg” (claim 13), with clinical study of daily dose (page 20).
Regarding claims 54-56, Deijnen teaches a combination kit (claims 29-31).
Thus, the claims are anticipated.
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 1-5, 7-17, 54-56, and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Beijnen et al. (WO2020127607, publ 2020-06-25) in view of Sissung et al. (Clin Cancer Res (2008) 14 (14): 4543–4549.).
Regarding claims 1-5, 7-17, 54-56, the prior art anticipates and renders obvious the claims as detailed above in the 35 USC 102 rejection.
Regarding claim 58, Beijnen teaches the anticancer combination of ritonavir with docetaxel in vivo in drug resistant cancers (Abstract, claim 11, 13-15). Although Beijnen teaches ABCB1 is involved in docetaxel transport (p. 6: “the P-glycoprotein (P-gp, MDR1, ABCB1) plays a role in the metabolic route and transport of docetaxel”), Bijnen does not teach determining expression of ABCB1 in the patient.
Sissung teaches assessment of ABCB1 expression in cancer patients treated with docetaxel to improve treatment efficacy (title, abstract).
One of ordinary skill in the art of cancer therapeutics would have considered assessing expression levels of biomarkers known to be related to the efficacy of a chemotherapy. Thus, one of ordinary skill in the art following the teaching of Beijnen would have readily considered assessing ABCB1 as taught by Sissung and arrive at the claimed invention with a reasonable expectation of success.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
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 1-5, 7-17, 54-56, and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11571408. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a combination of docetaxel with ritonavir (i.e., claim 11) that anticipates and renders obvious the instant claims.
Claims 1-5, 7-17, 54-56, and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2,5,12,15,18,20-25,28 and 32-36 of copending Application No. 17416946 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a combination of docetaxel with ritonavir that anticipates and renders obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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