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 .
DETAILED ACTION
Claims 26-42 are pending and are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/12/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application is a continuation of U.S application 16617471 filed on 11/26/2019 (granted as US Patent ) which is U.S. National phase application under 35 U.S.C 371 of PCT application PCT/US2018/035909, filed 06/04/2018 , which claims priority under 35 U.S.C 119 (e) from provisional application serial No. 62/515421 , filed 6/5/2017
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.
(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.
Claims 26-42 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Lian (US 11,202,789, priority 2/8/2017 and 11/21/2016, referenced in the instant IDS) as evidenced by Rojkind et al. (Abstract , Gastroenterology, Volume 76, (4), 1979, pages 710-719).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C.102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Instant claims are drawn to a method of treating fibrosis, a fibrotic condition or a fibrotic symptom in a subject in need thereof comprising administering to said subject in need thereof a compound having the structure
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or a pharmaceutically acceptable salt thereof.
Lian discloses method and compositions for the treatment of hepatic symptoms of glycogen storage diseases through the administration of thyroid hormone receptor agonists and the compositions are useful in the treatment of symptoms of glycogen storage disease such as hyperlipidemia, hypercholesterolemia, hepatic steatosis, cardiomegaly, hepatomegaly, hepatic fibrosis, and cirrhosis associated with glycogen storage diseases (GSD) and defects of glycogen metabolism (abstract, col. 6, lines 37-52). They disclose that the glycogen storage disease comprises one or more of glycogen storage disease types 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 among others (col.6, lines 12-36). The disclose the thyroid hormone receptor agonist to include compound 17 (col.17-18)
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Compositions taught by Lian are formulated with suitable excipients such as carriers, diluents, emulsifiers, binders, buffers etc. ( col.59, lines 35-col.60 line 38). The compositions are further formulated for oral, parenteral, topical etc. (Col.64, lines 16-34).
With regards to instant claims 35-38, and 40-42 Lian al. does not specifically teach that the patients with idiopathic pulmonary fibrosis had abnormal or excessive deposition of collagen nor do they disclose that the compound results in the reduction of the amount of extracellular matrix in the tissues, or in the reduction in the amount of collagen, (Type I, Type Ia or Type III) in one or more tissues of the subject.
However, Increase in the collagen in the fibrotic tissue is the typical pathology of liver fibrosis or Cirrhotic liver as evidenced by Rojkind et al. who discloses that cirrhotic livers regardless of etiology, all collagen Types were increased and , in cirrhotic livers Type I collagen was the predominant type, and the ratio of Type I/Type III collagen was increased. As such evidentiary documentation explicitly discloses that the increase in collagen in fibrotic liver such as those associated with a glycogen storage disease. As such patients of Lian would inherently have abnormal deposition of Collagen type I and III, absence of evidence to the contrary. Further the property of the instantly claimed compound to reduce the extracellular matrix proteins or reduce amount of collagen (type I, Ia or III) are functional limitation of the compound and would inherently occur when it is administered to the same subject for treatment of the same conditions which in this case is pulmonary fibrotic patients to decrease fibrosis. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[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." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition, it is also noted that “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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As such the instantly claimed functional limitations recited in claims 40-42 7 would be present in these agent taught by Lian and would therefore elicit these effects whenever it is administered to the fibrotic subject population (instantly claimed) for treatment of the instantly claimed condition which is fibrosis.
In accordance with MPEP §2131.01, it is proper to rely upon a secondary reference for a rejection under 35 U.S.C. 102, provided that the additional reference is relied upon to demonstrate that a characteristic or property not disclosed by the primary reference is, in fact, inherent.
Therefore the composition disclosed by Lian fully anticipates instant claims 26-42.
Conclusion
Claims 26-42 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dierdre (Renee) Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/ Primary Examiner, Art Unit 1691