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
Change of Examiner
The examiner assigned to the instant application has changed. The new examiner is Bong-Sook Baek. Contact information is provided at the end of this Office Action.
Status of Claims
A request for continued examination under 37 C.F.R. 1.114, including the fee set forth in 37 C.F.R. 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 C.F.R. 1.114, and the fee set forth in 37 C.F.R. 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 C.F.R. 1.114. Applicant’s submission filed May 15, 2025 has been received and entered into the present application.
The amendment filed on May 15, 2025 is acknowledged. A new claim 22 has been added. Claims 1-6, 8-10, and 22 are under examination in the instant office action.
Applicants' arguments, filed on May 15, 2025, have been fully considered but they are moot in view of a new ground of rejection. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Responses are limited to Applicants' arguments relevant to either reiterated or newly applied rejections.
Claim Objections
Claims 8-9 are objected to because of the following informalities: typographical errors.
In claim 8, the recitation “used to improve” in lines 2-3 should be amended to –improves-- to be grammatically correct.
In claim 9, the recitation “used to suppress” in lines 2-3 should be corrected to --suppresses-- to be grammatically correct.
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.
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 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.
Claims 1-4, 8-10 and 22 are rejected under 35 USC 103 as being unpatentable over
Oishi et al. (The Journal by of Nutrition, vol. 145 (2): 199-2061, published online Nov. 26, 2014; cited in the IDS filed on 7/26/2023) as evidenced by Hwang et al. (Journal of Gastroenterology and Hepatology, 16:190–195, 2001).
The instant claims are drawn to a method for improving symptoms of hepatitis in liver function (wherein the need for improving liver function is due to non-alcoholic hepatitis) comprising administrating to a subject having symptoms of hepatitis and elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase AST (level) in need thereof a composition for improving liver function comparing a plant-derived resorcinolic lipid such as alkylresorcinol as an active ingredient.
Oishi discloses a study about the effects of a composition comprising alkylresorcinol derived from wheat bran (Gramineae plant) as an active ingredient on diet-induced metabolic disorders in mice, wherein wheat alkylresorcinols increase glucose tolerance and insulin sensitivity by suppressing hepatic lipid accumulation and intestinal cholesterol absorption, which subsequently suppresses diet-induced obesity in mice (abstract). Oishi discloses that wheat contains alkylresorcinol homologs (carbon chain length C15:0–C25:0), the most abundant of which is C21:0 (p205, col 1, para 3).
Oishi teaches that oral administration of the composition comprising alkylresorcinol (provided as a food or animal feed) significantly suppressed FS-induced hepatic triglyceride (TG) accumulation and reduced glucose intolerance and insulin resistance induced by the FS diet (abstract-results). Oishi further discloses that alkylresorcinols significantly increased fecal cholesterol excretion by 39.6% and reduced blood cholesterol concentrations by 30.4% (abstract-results).
Oishi concludes that the chronic intake of wheat alkylresorcinols suppresses diet-induced obesity, hyperinsulinemia, hyperleptinemia, hepatic steatosis, glucose intolerance, and insulin resistance accompanied by an increase in fecal cholesterol excretion (p205, col 1, para 3). Oishi further teaches that fatty liver (hepatic steatosis) is closely associated with insulin resistance and the promotion of impaired glucose tolerance, and individuals who consume diets rich in whole grains might have a lower risk of fatty liver (p204, col 2, para 2).
Thus, the reference teaches that the composition comprising alkylresorcinol derived from wheat reduces hepatic lipid accumulation via suppressing TG accumulation and increasing fecal cholesterol excretion, thereby improving liver function and treating fatty liver (hepatic steatosis), in a subject in need thereof.
The reference does not specifically disclose that the subject has a symptom of hepatitis and elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST).
However, it was known in the art that hepatic steatosis (hepatic lipid accumulation) is a histological characteristic in patients with chronic hepatitis C virus (HCV) infection (non-alcoholic hepatitis) as evidenced by Hwang et al. Patients with hepatic steatosis had significantly higher mean serum levels of triglyceride, increased cholesterol, ALT, and AST levels, and g-glutamyl transpeptidase, higher body mass index, and a higher incidence of obesity compared with patients without hepatic steatosis (abstract and Table 1).
It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to use a composition comprising alkylresorcinol for improving symptoms of hepatitis such as hepatic steatosis (hepatic lipid accumulation) because alkylresorcinol is taught to be effective for suppressing hepatic TG accumulation, glucose intolerance and insulin resistance and increasing fecal cholesterol excretion, thereby being useful for treating hepatic steatosis as evidenced by Oishi. The skilled artisan would have been motivated to do so on the reasonable expectation that the alkylresorcinol would be effective for improving liver function in patients with hepatitis who have hepatic steatosis as its symptom and increased ALT and AST levels via suppressing hepatic lipid accumulation as taught by Oishi.
As to new claim 22, it would have been facie obvious to one of ordinary skilled in the art to measure AST and ALT for determining improvement of the symptom of hepatitis such as hepatic steatosis and liver function because AST and ALT are well known indicator of liver function and patients with hepatic steatosis have increased ALT and AST levels as evidenced by Hwang et al.
Claims 1-6, 8-10 and 22 are rejected under 35 USC 103 as being unpatentable over
Oishi et al. (The Journal by of Nutrition, vol. 145, no.2, 1 February 2015 (2015-02-01), page 199-206; cited in the IDS filed on 7/26/2023) as evidenced by Hwang et al. (Journal of Gastroenterology and Hepatology, 16:190–195, 2001) in view of US 2017/0095428.
The teachings of Oishi et al. and Hwang et al. as applied supra are herein applied for the same teachings in their entirety.
Oishi et al. do no specifically teach the use of the resorcinolic lipid such as alkylresorcinol in an ethanol extract of a plant than contains the resorcinolic lipid recited in claims 5-6.
However, it was known in the art that ethanol extracts of gramineous plants such as wheat and rye contain alkylresorcinols as evidenced by US 2017/0095428 (abstract, [0024], [0025], and claims 1 and 8). US 2017/0095428 discloses that alkylresorcinol mixture obtained from the ethanol extract of wheat bran lowered blood glucose level and decreased hepatic triglyceride content, revealing the effect for preventing and treating fatty liver ([0075], [0082], and [0097]-[0102]).
Thus, it would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to use an ethanol extract of gramineous plants such as wheat and rye as a source of alkylresorcinols because the ethanol extracts of gramineous plants contain alkylresorcinols and has been used as a source of alkylresorcinols as evidenced by US 2017/0095428. The skilled artisan would have been motived to do with a reasonable expectation of success.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONG-SOOK BAEK whose telephone number is 571-270-5863. The examiner can normally be reached 9:00AM-6:00PM Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611