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 Objections
Claim 9 is objected to because of the following informalities: Claim 9 recites “The method of claim 9”. The limitations of the claim suggest it is further limiting claim 8 on the biomarkers of liver disease. Appropriate correction is required.
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.
Claims 1-2, 5-11, 14-22 and 25-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patel et al. (US 20200022991 A1).
Regarding claims 1-2, 5-11, 14-22 and 25-28, Patel teaches a method for treating a liver disease or condition, or a symptom thereof, in a male and/or female subject in need of treatment, comprising a pharmaceutical composition at least one steroidal compound of testosterone, or an ester thereof and a pharmaceutically acceptable excipient (relevant to claims 1, 10, 19-20) (abstract, Para. 0011, 0119). Of the liver diseases Patel teaches NAFLD (relevant to claims 2, 5-6, 11, 14-15, 22, 25) (para. 0007) being treated by steroidal testosterone of dihydrotestosterone (relevant to claims 7, 16, 26) (Para. 0167).
Patel additionally teaches a method of diagnosing and treatment of a liver disease of NAFLD comprising analyzing the subjects for at least one or more biomarkers of cholesterol levels, triglycerides and wherein the biomarkers are restored to normal levels after treatment (relevant to claims 8-9, 17-18, 21, 27-28) (Para. 0149, Table 2).
Claims 1-2, 5-6, 10-11, 14-15, 19-22 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ayako et al. (WO 2015053379 A1).
Regarding claims 1-2, 5-6, 10-11, 14-15, 19-22 and 25, Ayako teaches a method for the treatment of a fatty liver disease or disorder of NAFLD and NASH in a pre and post-menopausal woman comprising a pharmaceutical composition of at least one compound selected from the group consisting of ethyl eicosapentanoate (EPA-E), eicosapentaenoic acid (EPA) and its pharmaceutically acceptable amides, salts, esters and phospholipids, in combination with an estrogen, progesterone, progestin or any combination thereof and a pharmaceutical acceptable excipient (relevant to claims 1-2, 5-6, 10-11, 14-15, 19-20) (Para. 0006, 0093, 00222).
Ayako additionally teaches the prevention of developing NAFLD and NASH comprising measuring the level of biomarkers, comparing the level of biomarkers to a normal level and administration of the above composition (relevant to claims 21-22, 25) (Para. 0095, 00135).
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.
Claims 3-4, 12-13 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ayako et al. (WO 2015053379 A1).
The teachings of Ayako for the above 102 rejection of claims 1-2, 5-6, 10-11, 14-15, 19-22 and 25 is incorporated herein by reference.
Ayako additionally teaches the treatment of liver disease to menopausal woman in which menopause (no menstrual periods) happens due to some functional disorder affecting the reproductive system such as endometriosis and polycystic ovary syndrome (PCOS).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have administered the composition taught by Ayako to a woman who displays a clinical feature associated with PCOS of menopause. One would be motivated to do so as Ayako teaches the steroid hormone composition administered to menopausal women caused by PCOS. There is a reasonable expectation of treating a liver disease to a woman who displays a clinical feature associated with PCOS of menopause from the teachings of Ayako.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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