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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 .
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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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu WO2017088213, Wang, Nat. Prod. Bioprospect. (2015) 5:237–246, Geethangili, Evidence-Based Complementary and Alternative Medicine Volume 2011, Article ID 212641, 1-17.
Wang teaches compounds antcin compound from Antrodia cinnamomea. See page compounds of instant claim 3 in Fig 1 (first structures) at page 239. According to Wang, page 238 column A, Antrodia cinnamomea (or A. camphorata, Polyporaceae family, known as ‘‘Niu-Chang-Chih’’ in Chinese) is a precious medicinal mushroom. It has been reported to exhibit anticancer, antioxidant, anti-inflammatory, anti-angiogenesis, liver protection and radioprotection activities.
Hu discloses a method of treating a liver disease or disorder in a subject in need thereof (machine translation - pg. 2, In 60-62: treatment of drug-induced liver injury), the method comprising: administering (pg. 4, In 158-159: oral administration) to the subject a therapeutically effective amount of antcin H in preparing drugs for treating and preventing drug-induced liver injury (see Abstract). For structure of antcin compounds see pages, 2, 4, 8, 9.
Geethangili reference is Review of Pharmacological Effects of Antrodia camphorata and
Its Bioactive Compounds. The bioactive compounds pictured at page 4 Table include the instantly pictured compounds. Starting at page 3, column A, Geethangili teaches the plethora of possible diseases (see claim 5) that could be treated with the said compounds. Claims 6-10 could also be interpreted as being drawn to dose(s) of vaguely defined compounds. For example, claim 6 is drawn to the known biological property of the endogenous bile acid (CDCA is selectively activates the orphan nuclear receptor, see Wong, Volume 3, Issue 5, May 1999, Pages 543-553; also see Stephen B. Hulley, Designing Clinical Research, 4th Edition, pages 1-367, 2013. These references are not in the rejection statement because these are well-known and therefore regarded as being within the purview of one of skill in the art).
As such the difference between the prior art teaching and instantly claimed method is in the language relating to FXR and other biological property (see claim 1, 6-8).
The position taken is that the above difference relates to the inherent property of the compounds from Antrodia cinnamomea.
As per disclosure the compounds such as the ones of claim 3 are useful for treating any and all diseases selected from selected from a liver disease, obesity, diabetes, diarrhea, abdominal pain, hypertension, itchy skin, liver cancer, hepatitis, biliary cholangitis, nonalcoholic steatohepatitis, primary sclerosing cholangitis, inflammation, and fibrosis.
The cited reference independently teach that these compounds are known to be useful for treating these diseases
As per MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-10.2019], "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer."
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625