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 .
Non-Final Rejection
The Status of Claims:
Claims 1-20 are pending.
Claims 1-20 are rejected.
DETAILED ACTION
1. Claims 1-20 are under consideration in this Office Action.
Priority
2. It is noted that this application is a continuation of 18051937 11/02/2022ABN , which is a continuation of 16348189 05/08/2019ABN, which is a 371 of PCT/MX2017/000129 11/09/2017 , which has a foreign priority document, MEXICO MX/A/2016/014775 11/11/2016.
Drawings
3. The drawings filed on 12/02/2024 are accepted by the examiner None.
IDS
4. The IDS filed on 7/10/2025 are reviewed by the examiner.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
5. Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ozes et al(WO 2005/000227) in view of Armendariz Borunda et al. (US 20140296300).
Determination of the scope and content of the prior art
Ozes et al teaches a method of treating non-alcoholic steatohepatitis (NASH)
comprising administering to an individual in need thereof an effective amount of
pirfenidone as in claims 1(partially),19 , (see abstract; claim 12). It is taught that NASH is described as the presence of large droplet steatosis (fatty change, macrovesicular or microvesicular steatosis) accompanied by evidence of hepatocellular necrosis and fibrosis (see pages 45-46, Example 1, paragraphs#00171 -00173). It is also taught that pirrenidone has been shown to down regulate the production TNF-α as well as to regulate the production of TGF-β (see page 45, a paragraph#00172).
Furthermore, it teaches that symptoms of NASH include increase in fat content of liver cells as in claims 3-5, 20 (partially) . (see page 20, paragraphs# 0084-0085: pages 20-21). It is taught that the agents such as pirfenidone can be formulated into pharmaceutical compositions to obtain compositions in the form of tablets, capsules (see page 26, paragraphs# 00104-00105).
The current invention, however, differs from the prior art in that the claimed administration of a composition comprising pirfenidone in the form of extended release tablets having between 100 mg and 600 mg to treat NASH and the claimed decreasing serum levels of IL-17A, IL-6, IL-1p, IL-10. IFN-y, TNF-a. decreasing expression of TGF-31, decreasing NFkB, increasing expression of SREBPl, expression of CPT1A, expression of PPAR gamma are unspecified in the prior art.
Armendariz Borunda et al teaches a method of treating hepatic fibrosis comprising administering a sustained release tablet comprising 600.0 mg of pirfenidone. as in claims 2 and 18 (see abstract, page 9, claims 2, 9; page 6, a paragraph#0121). It is taught that the sustained release tablet offers advantage and better therapeutic efficacy in the regression of human hepatic fibrosis(see page 1, a paragraph#0001). It is taught that the animals with chronic hepatic damage have a lower TGF-131 serum level, a lower TNF-a serum level when treated with pirfenidone(see page 8, paragraphs#0151-0152). It is taught that pirfenidone is under clinical evaluation as a wide spectrum antifibrotic drug, pirfenidone has anti-fibrotic and anti-inflammatory properties as in claim 7 that are reflected in its activity of lowering the expression of TGF-beta.1, TNF-alpha, PDGF and most importantly, the expression of different types of collagens(see page 1 , paragraphs#[0002-004).
Ascertainment of the difference between the prior art and the claims
The difference between the instant application and the applied Ozes et al art is that the Ozes et al does not expressly teach the the claimed administration of a composition comprising pirfenidone in the form of extended release tablets having between 100 mg and 600 mg to treat NASH and the claimed decreasing serum levels of IL-17A, IL-6, IL-1p, IL-10. IFN-y, TNF-a. decreasing expression of TGF-31, decreasing NFkB, increasing expression of SREBPl, expression of CPT1A, expression of PPAR gamma
The deficiencies of the Ozes et al are partially cured by the Armendariz Borunda et al.
The difference between the instant application and the applied Armendariz Borunda et al art is that the Armendariz Borunda et al does not expressly teach the claimed method of treating or reversing non-alcoholic steatohepatitis (NASH) directly and the claimed decreasing serum levels of IL-17A, IL-6, IL-1p, IL-10. IFN-y, TNF-a. decreasing expression of TGF-31, decreasing NFkB, increasing expression of SREBPl, expression of CPT1A, expression of PPAR gamma. The deficiencies of the Armendariz Borunda et al are partially cured by the Ozes et al.
Resolving the level of ordinary skill in the pertinent art.
Regarding the Claims 6, 8-17, with respect to the lack of disclosing the claimed decreasing serum levels of IL-17A, IL-6, IL-1p, IL-10. IFN-y, TNF-a. decreasing expression of TGF-31, decreasing NFkB, increasing expression of SREBPl, expression of CPT1A, expression of PPAR gamma, the prior art are silent about them . However, they are directly related to the properties of the composition comprising pirfenidone on administration to a patient suffering from NASH and advanced fibrosis; furthermore, the properties are inseparable from its composition on administration to a patient with NASH, and advanced fibrosis. Therefore, the prior art are still relevant to the claimed invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Ozes et al expressly discloses the method of treating non-alcoholic steatohepatitis (NASH) comprising administering to an individual in need thereof an effective amount of pirfenidone which can reduce symptoms of NASH including increase in fat content of liver cells. Similarly, Armendariz Borunda et al does teach the method of treating hepatic fibrosis comprising administering a sustained release tablet comprising 600.0 mg of pirfenidone.
Both are closely related to each other in a relationship between the method of treating NASH and the method of treating hepatic fibrosis using the same pirfenidone compound; also, NASH results in fibrosis.
So, if the skilled artisan in the art had desired to treat a subject suffering from NASH, fatty liver diseases and advanced hepatic fibrosis, it would have been obvious to the skilled artisan in the art before the effective filing date of the claimed invention to be motivated to incorporate the teachings of Armendariz Borunda et al about administering a sustained release tablet comprising 600.0 mg of pirfenidone into the Ozes et al method of treating non-alcoholic steatohepatitis (NASH) and fatty liver for longer and better therapeutic effect. This is because the skilled artisan in the art would expect such combined methods to be successful and feasible as guidance shown in the prior art.
Conclusion
Claims 1-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached on 8:00-5:00.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 9/10/2026
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