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 1-5 are presented for examination.
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)(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.
Claim(s) 1, 2 and 4 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Emanuele et al. (US 20160000823).
The claims are drawn to A pharmaceutical composition for improving the filtering function of the kidneys of a subject, comprising poloxamer-188 as a pharmacologically active substance and at least one excipient.
Regarding claim 1, Emanuele et al. teach methods and uses of polyoxyethylene/polyoxypropylene copolymers (poloxamers) for treating bleeding and hemorrhage in animals, including human or veterinary subjects, and thus, treating hemostatic dysfunction, resulting from, for example, drug, disease-, trauma- or surgical-induced bleeding. See the abstract. The use of poloxamer 188 is taught in Paras [0015], [0113], [0118], examples and claim 5. The use of excipients is taught in Para [0358]. Emanuele et al. does not teach the use of the claimed composition for improving function of the kidneys of a subject. However, the claim is a composition claim, which reads of the claimed compound in a composition regardless of what it is used for. Furthermore, the improvement of filtering function of the kidney is the inherent property of Emanuele, which teaches the same composition as the claimed composition. Applicant’s attention is drawn to In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990), wherein the court stated "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 2, Emanuele teaches the mode of administration (i.e., systemic, oral, nasal, pulmonary, local, topical, or any other mode). See Para [0356]. Emanuele et al. also teach a “composition” can be a solution, a suspension, liquid, powder, a paste, aqueous or non-aqueous formulations or any combination thereof. See Para [0156].
Regarding claim 4, Emanuele teaches as used herein, “subject” refers to an animal, particularly human or a veterinary animal, including dogs, cats, pigs, cows, horses and other farm animals, zoo animals and pets. See Para [0156].
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) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emanuele et al. (US 2016/0000823).
The claims are drawn to A pharmaceutical composition for improving the filtering function of the kidneys of a subject, comprising poloxamer-188 as a pharmacologically active substance and at least one excipient.
Regarding claim 1, Emanuele et al. teach methods and uses of polyoxyethylene/polyoxypropylene copolymers (poloxamers) for treating bleeding and hemorrhage in animals, including human or veterinary subjects, and thus, treating hemostatic dysfunction, resulting from, for example, drug, disease-, trauma- or surgical-induced bleeding. See the abstract. The use of poloxamer 188 is taught in Paras [0015], [0113], [0118], examples and claim 5. The use of excipients is taught in Para [0358]. Emanuele et al. does not teach the use of the claimed composition for improving function of the kidneys of a subject. However, the claim is a composition claim, which reads of the claimed compound in a composition regardless of what it is used for. Furthermore, the improvement of filtering function of the kidney is the inherent property of Emanuele, which teaches the same composition as the claimed composition. Applicant’s attention is drawn to In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990), wherein the court stated "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 2, Emanuele teaches the mode of administration (i.e., systemic, oral, nasal, pulmonary, local, topical, or any other mode). See Para [0356]. Emanuele et al. also teach a “composition” can be a solution, a suspension, liquid, powder, a paste, aqueous or non-aqueous formulations or any combination thereof. See Para [0156].
Regarding Claim 3, Emanuele et al. teach that he dosage of the polyoxyethylene/polyoxypropylene copolymer (poloxamer) is at least about 20 mg/kg, or at least about 50 mg/kg or is at least 100 mg/kg or at least about 100 mg/kg or is at least 150 mg/kg or at least about 150 mg/kg or between about 50-1200 mg/kg. See Claim 59 and 60. The dosage of the claimed composition is within the scope of 50-1200 mg/kg concentration of Emanuele et al. The determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. Applicant’s attention is drawn to In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), where the court stated “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."
Regarding claim 4, Emanuele teaches as used herein, “subject” refers to an animal, particularly human or a veterinary animal, including dogs, cats, pigs, cows, horses and other farm animals, zoo animals and pets. See Para [0156].
Regarding claim 5, Emanuele et al. teach that multiple administrations can be effected via any route or combination of routes, and can be administered hourly (e.g. every hour or 2 hours, every three hours, every four hours or more), daily, weekly or monthly. See Para [0377]. Emanuele et al. dose not teach the specific daily administration for 6 months. However, It would have been obvious to a person skilled in the art to select a mode and interval of administration within the scope of Emanuele et al. in the absence of evidence to the contrary.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616