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 .
Claims 2-5, 8-10, 12, 14, 16-18 and 39 are presented for examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/12/2026 has been entered.
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.
Claim(s) 2-10, 12, 14, 16-18 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman (US 20150246059) in view of Szente et al. (Fatty Acid-Cyclodextrin Complexes: Properties and Applications) and further in view Saenger (Cyclodextrin Inclusion Compounds in Research and Industry).
Freeman teaches the nitrated lipids and methods of making and using the nitrated lipids. See the abstract. The claimed compounds are taught in Para [0071]-[0087]. Freeman teaches that Parenteral administration of the composition, if used, is generally characterized by injection. Injectables can be prepared in conventional forms, either as liquid solutions or suspensions, solid forms suitable for solution of suspension in liquid prior to injection, or as emulsions. See Para [0107]. Freeman teaches that formulations for topical administration may include ointments, lotions, creams, gels, drops, suppositories, sprays, liquids and powders. Conventional pharmaceutical carriers, aqueous, powder or oily bases, thickeners and the like may be necessary or desirable. See Para [0114]. Freeman teaches that compositions for oral administration include powders or granules, suspensions or solutions in water or non-aqueous media, capsules, sachets, or tablets. Thickeners, flavorings, diluents, emulsifiers, dispersing aids or binders may be desirable See Para [0115]. Freeman teaches that in one aspect, the unsaturated lipid comprises oleic acid, linoleic acid, linolenic acid, arachidonic acid, eicosapentaenoic acid, or docosahexaenoic acid. See Para [0098]. The use of 10-nitro-9-octadecenic acid (oleic acid) is taught in claim 83.
Freeman differs from the claimed invention in the presence of cyclodextrin. Szente et al. teach that complexation of fatty acids (both saturated and unsaturated with various cyclodextrins and cyclodextrin derivatives greatly modifies their properties. Inclusion complex formation depending upon the type of host cyclodextrin may result in protection against the environment, in improved water solubility and bioavailability. Thus, lipid complexation enables the preparation of more reliable diagnostic reagents, better chromatographic separations and higher yields in biotechnological processes. See the abstract. The use of beta-cyclodextrin is taught in the experiments, on page 4. Saenger teaches the use of cyclodextrin for stability of compounds having a nitro. See Table 3,
It would have been obvious to a person skilled in the art to add cyclodextrin to the composition of Freeman, motivated by the teachings of Szente, which teaches the inclusion of beta-cyclodextrin may result in protection against the environment, in improved water solubility and bioavailability of fatty acids. Saenger makes clear that cyclodextrin have been used for the stability of compounds having a nitro group.
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 2-10, 12, 14, 16-18 and 39 rejected on the ground of nonstatutory double patenting as being unpatentable over claim1-4 of U.S. Patent No. 10,869,850, claims 4-32 of U.S. Patent No. 10,751,310, claims 1-5 of the U.S. Patent No. 10,765,652, claims 17-20 of the U.S. Patent 8,309,526, claims 1-2 of the U.S. Patent 10,258,589 and claims 1-9 of U.S. Patent 8,735,449 in view of Szente et al. and Saenger (Cyclodextrin Inclusion Compounds in Research and Industry).
Szente et al. teach that complexation of fatty acids (both saturated and unsaturated with various cyclodextrins and cyclodextrin derivatives greatly modifies their properties. Inclusion complex formation depending upon the type of host cyclodextrin may result in protection against the environment, in improved water solubility and bioavailability. Thus, lipid complexation enables the preparation of more reliable diagnostic reagents, better chromatographic separations and higher yields in biotechnological processes. See the abstract. The use of beta-cyclodextrin is taught in the experiments, on page 4. Saenger teaches the use of cyclodextrin for stability of compounds having a nitro. See Table 3.
It would have been obvious to a person skilled in the art to add cyclodextrin to the composition of Freeman, motivated by the teachings of Szente, which teaches the inclusion of beta-cyclodextrin may result in protection against the environment, in improved water solubility and bioavailability of fatty acids. Saenger makes clear that cyclodextrin have been used for the stability of compounds having a nitro group
Response to Arguments
Applicant’s arguments regarding the obviousness and double patenting have been noted. Applicant in his remarks argues that “Kadri describes the inclusion of complexes of 2-chloroethylnitrosulfamides (CENS) with ß- cyclodextrin. All the presently claimed compositions and methods recite an active compound that includes a nitro (-NO₂) group. CENS does not contain a nitro (-NO₂) group.”. The examiner has relied on Saenger to show that cyclodextrins have been previously used for stabilizing compounds having a nitro group. Furthermore, Szente, teaches the inclusion of beta-cyclodextrin may result in protection against the environment, in improved water solubility and bioavailability of fatty acids. Saenger makes clear that cyclodextrin have been used for the stability of compounds having a nitro group
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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