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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/28/2023 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 recites "the structure of which are as follows" which is grammatically incorrect and should recite "the structures of which are as follows".
Appropriate correction is required.
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kasai et al. “Creation of Pure Nanodrugs and Their Anticancer Properties” Angew. Chem. Int. Ed. 2012, 51, 10315 –10318 in view of CN107669626 (Jiang et al., 08/28/2023 IDS Foreign Patent Number 3).
Kasai et al. teaches anticancer SN-38 dimers with various linkers (carbamate, ester and ether) at the phenolic hydroxy group of the parent molecule. See Scheme 1. SN-38 is a prodrug of Irinotecan which is a derivative of camptothecin. Roughly spherical 30-50 nm nanoparticles of the carbamate dimer are taught (p. 10317).
The claimed compounds such as SN0DC differ from the prior art compounds in that they utilize carbonate-alkylene-disulfide linkers which are attached to the lactone hydroxy group of SN-38.
Jiang et al. teaches camptothecin dimers with carbonate-alkylene-disfulfide linkers which are attached to the lactone hydroxy group of camptothecin. See claim 1. Para. [0003] states “the drug delivery system has a drug loading of 1% to 12.6% %, and the drug delivery system has reduction sensitivity, good biocompatibility and the ability to inhibit tumor cell proliferation, and can be used to prepare slow-controlled release and targeted anticancer drugs.” A PHOSITA would have been motivated to form an SN-38 dimer with carbonate-alkylene-disulfide linker attached to the lactone hydroxy group of SN-38 based upon the teachings of Kasai et al. in view of Jiang et al. in order to prepare slow-controlled release and targeted anticancer drugs. This would result in the claimed compound SNC0DC wherein R1 is hydroxy and R2 is ethylene with respect to claims 1-12. There would have been a reasonable expectation of success in producing effective anticancer drugs because the parent molecules of each compound, SN-38 and camptothecin, are recognized in the art as analogous. With respect to claims 2 and 4, ClogP is an inherent property that would have necessarily flowed from the combined teachings of the prior art. With respect to claim 4, Kasai et al. teaches roughly spherical 30-50 nm nanoparticles of the carbamate dimer are taught (Figure 1b, p. 10316). With respect to claims 5-6 and 8-9, anticancer activity is taught by both prior art and claim 6 is drawn to an intended use which does not structurally limit the product and therefore is not given patentable weight. With respect to claim 7, Kasai et al. teaches that said synthetic methods are routine in the art (p. 10315, last paragraph) and are applied to the prior art nanoparticles (p. 10316, first paragraph). Accordingly, claims 1-12 are obvious.
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 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 19135429 in view of CN107669626 (Jiang et al.).
Claims 1-12 of copending Application No. 19135429 are drawn to compounds of General Formula (1) and nanoparticles, medicines and methods of use thereof.
The compounds differ from those instantly claimed in that they have an ester-alkylene-disulfide linker attached to the phenolic hydroxy group of each SN-38 moiety.
Jiang et al. teaches camptothecin dimers with carbonate-alkylene-disfulfide linkers which are attached to the lactone hydroxy group of camptothecin. See claim 1. Para. [0003] states “the drug delivery system has a drug loading of 1% to 12.6% %, and the drug delivery system has reduction sensitivity, good biocompatibility and the ability to inhibit tumor cell proliferation, and can be used to prepare slow-controlled release and targeted anticancer drugs.” A PHOSITA would have been motivated to form an SN-38 dimer with carbonate-alkylene-disulfide linker attached to the lactone hydroxy group of SN-38 based upon the copending claims in view of Jiang et al. in order to prepare slow-controlled release and targeted anticancer drugs. This would result in the claimed compound SNC0DC wherein R1 is hydroxy and R2 is ethylene with respect to claims 1-12. There would have been a reasonable expectation of success in producing effective anticancer drugs because the parent molecules of each compound, SN-38 and camptothecin, are recognized in the art as analogous.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-12 are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623