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 .
Claim Rejections - 35 USC § 102/103
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.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 14-17, 19-22 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Pontisso et al., (WO 2018/163119 cited in IDS).
Pontisso et al. teaches “1-piperidinepropionic acid or pharmaceutically acceptable salts thereof, or pharmaceutical compositions comprising it, for use in the treatment of chronic fibrosing diseases” (Abstract).
In regard to claims 15-17, Pontisso et al. teaches, “By way of example, the composition according to the present description could comprise from 0.01 mg to 10 mg, preferably from 0.05 mg to 5 mg, even more preferably from 0.1 mg to 1mg of PPA as unit dose, and one or more doses (or fractions of doses) of said composition could be administered to the patient. Alternately, the composition could be suitably metered according to the opinion of the doctor in charge” (p. 6, lines 9-13).
Regarding claims 18-21, Pontisso et al. further teaches, “The composition according to the invention could be a composition for parenteral, oral, nasal, aerosol, systemic administration, and could be formulated in the form of suspension, emulsion, cream, spray, granules, powder, solution, capsule, tablet, pill, lyophilized product, lozenge, intramuscular or intravenous injection according to conventional pharmaceutical formulations techniques, with suitable excipients, carriers, preservatives, diluents and the like” (p. 6, lines 14-18).
The prior art teaches administering 1-piperidine propionic acid (PPA) to a patient in an animal model, where PPA was shown to reduce inflammatory damage. Animals were administered PPA daily by intraperitoneal route (p. 8, lines 22-29).
Regarding claim 22, PAR2 is inherent to the patient population. Therefore, contact of PAR2 with PPA, post administration, would have been inevitable.
The prior art is anticipatory insofar as it teaches administering 1-piperidine propionic acid or a salt thereof to a patient. The patient population of the prior art would have been in need thereof of preventing PAR2 related pathological conditions, such as, hantavirus pulmonary syndrome.
Assuming, purely arguendo, that the prior art does not provide sufficient specificity to give rise to anticipation, it would have been obvious to administer 1-piperidine propionic acid (PPA) to patients in need thereof of preventing PAR2 related pathological conditions.
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.
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) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pontisso et al., (WO 2018/163119, cited in IDS) as applied to claim 1 above, and further in view of Socie (blood, 29 March 2018).
Pontisso et al., which is taught above, insofar as it does not teach a delivery system, e.g., liposome.
Socie teaches a method of treating “chronic graft-versus-host disease (GVHD)” in a fibrosis patient, where the method shows “vitamin A-coupled liposomes carrying heat shock protein 47 (HSP47) small interfering RNA (siRNA) ameliorate chronic GVHD-induced fibrosis” (Abstract).
Further, “Using vitamin A-coupled liposomes (that bind RBP1) carrying HSP47 siRNA (to inhibit HSP47), they demonstrated that they can inhibit HSP47 expression in TGF-β-stimulated fibroblasts in vitro and that VA-lip HSP47 specifically target skin fibrotic lesions in a multiple minor mismatched chronic GVHD model” (p. 1476, right column, 2nd paragraph).
MPEP 2144.07 states: The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
In this case, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use liposomes as delivery system for treating fibrosis in the method of Pontisso et al. based on the art recognized suitability in using liposomes to treat fibrosis in a patient, as taught by Socie.
Nonstatutory Obvious-type 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 14-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,628,163. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a method of administering 1-piperidine propionic acid or salt thereof to a patient. The patient population of the ‘163 patent and the instant claims overlap insofar as steatohepatitis of the ‘163 patent causes “visceral pain”, which is a disease state claimed in the instant method.
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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