N action
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 .
Status of Claims
Claims 1-13 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 10/26/23 and 5/31/23. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 7, 10 and 13 are rejected under 35 U.S.C. 101 because the claimed invention lacks patentable utility. Claims 13 and 25 are directed to a method of treating but shows a method of assaying an invention that is different from what is defined in the claim(s) because the steps shown in the claims are directed to an assay and not a method of treatment. The claim is also rejected as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: step(s) for treating or administration in s subject.
Claims 7, 10 and 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. This claim is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). The term “use of” is not among the statutory class of inventions.
Thus, the use of the combination according to claim 1 for the comprehensive maintenance of the detoxification function and restoration of the liver is not supported by a well established utility and for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
However in order to advance prosecution, this claim will be treated as a composition of use claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The term for example is unclear as to the meets and bounds of the phrase. Does it mean to include or exclude other thiamines. Clarification is required.
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.
The factual inquiries 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.
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.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (ACS Sustainable Chemistry and Engineering (2017), 5:8424-8428) in view of Suman (WO 2020/118188) and Pflucker et al. (US 2003/0060426).
Liu teaches with regards to instant claim 1, synergistic antioxidant performance of lignin and quercetin (see Tittle) wherein the amount of mixed lignin and quercetin 5-500 mg (see pg 8425, lft col. Experimental section). Thus reasonable to have the amounts from at least 5 mg of the quercetin and at least 50 mg of the lignin as required by the claims 1-2.
However Liu fails to teach the individual specific amounts of quercetin and lignin and fails to teach instant claims 3.
Suman teaches a composition for the release of migraine (see abstract and pg. 4) wherein the composition comprises dihydromyricetinin an amount ranging from 5-1000 (see pg. 10, 2nd para as required by instant claims 1-2), wherein the composition is in the form of a powder (as required by instant claim 6, see pg 5, last para) for aiding liver function (as required by instant claim 8) wherein the composition is a beverage (i.e., food, see pg 5, as required by instant claim 8 in the form of a powder (as required by instant claim 9, see pg. 5) and comprises vitamins, gluthathione etc as auxiliary substances (see pg. 6 as required by instant claims 8 and 11-12, biological active).
Pflucker teaches formulation for oxidative stress (see abstract) comprising quercetin (see 0049), glycine (see 0097), thiamine (see 0099) (as required by instant claim 3) as food supplement (see 0001).
It would have been obvious to one of ordinary skill in the art to expand the teachings of Liu, to include Suman and Pflucker in producing a formulation for reducing oxidative stress to have the amounts of quercetin or dihydrmyricetin, hydrolytic lignin in the required amounts as stated because the determination of a dosage having the optimum therapeutic index is well within the level of the ordinary skill in the art, and the artisan would be motivated to determine the optimum amounts to get the maximum effect of the drug, hence the reference makes obvious the instant invention. Therefore since the combined references teaches the agents can be used for treating oxidative stress, it is well within the purview of the skilled artisan to determine the amounts based on how it is administered i.e., in food, tablets, drinks/beverages etc.
Therefore, One would have been motivated to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concerns about. MPEP 2141.01(a).
The motivation to combine can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. Section MPEP 2144.07.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 8/28/25