DETAILED 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 .
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.
Claims 32 and 38 are 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. Claim 32 depends from claim 1, which is canceled. Claim 38 recites “at least two of the five or more calibrators are configured to ionize both positively and negatively.” It is unclear if this means that the two calibrators produce both positive and negative ions when ionized, or are used in a positive ionization mode as well as a negative ionization mode, separately.
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.
Claim(s) 31, 32, 34-36 and 39-50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jia (U.S. Patent Application Publication 2021/0116467A1).
Regarding claim 31, Jia discloses a kit for metabolic analysis of a sample, comprising:
Five or more calibrators configured to be used as universal standards with a mass spectrometry machine equipped with a molecular ion source to quantify a plurality of metabolites associated with one or more metabolic pathways (paragraphs 0076-0084; Fig. 11).
Regarding claim 32, Jia discloses wherein the five or more calibrators comprise 5 to 20 calibrators (Fig. 11).
Regarding claim 34, Jia discloses wherein the one or more metabolic pathways are associated with fatty acid metabolism (paragraph 0084).
Regarding claim 35, Jia discloses wherein the five or more calibrators comprise at least two calibrators from different chemical classes (paragraph 0084).
Regarding claim 36, Jia discloses wherein the different chemical classes are selected from the group consisting of nucleic acids, small molecules, proteins, amino acids, ethers, and sugars (paragraph 0084).
Regarding claim 39, Jia discloses wherein the five or more calibrators are stable at room temperature in acidic and basic conditions or matrices (paragraph 0088).
Regarding claim 40, Jia discloses wherein the five or more calibrators comprise a plurality of calibrators that are non-reactive with each other and/or with the one or more metabolites (paragraphs 0076-0099).
Regarding claim 41, Jia discloses wherein the five or more calibrators have a pH ranging from 2 to 10 (paragraphs 0089-0099).
Regarding claim 42, Jia discloses wherein the plurality of metabolites comprises at least two analytes having a same or similar property (paragraph 0088).
Regarding claim 43, Jia discloses wherein the same or similar property comprises a molecular mass or weight, a molecular structure, a chemical property, a physical property, or an ionization efficiency (paragraph 0088).
Regarding claim 44, Jia discloses wherein the number of the plurality of metabolites is greater than a number of the five or more calibrators (paragraph 0084).
Regarding claim 45, Jia discloses a set of instructions for using the five or more calibrators to determine an absolute concentration of the one or more of the plurality of metabolites in the sample (paragraph 0232).
Regarding claim 46, Jia discloses one or more quality control samples for verifying or validating an absolute concentration of one or more of the plurality of metabolites (paragraph 0231).
Regarding claim 47, Jia discloses a column configured to interface with a liquid chromatography system that is coupled to the MS machine and tubing for preparing, collecting, or delivering the sample to a liquid chromatography system or the MS machine (paragraph 0223).
Regarding claim 48, Jia discloses a standard mixture for generating a sample mixture comprising the five or more calibrators and the plurality of metabolites (paragraph 0023).
Claims 49 and 50 are drawn to the method of providing the kit of claims 31 and 47, and the same rejections apply mutatis mutandis.
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) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jia.
Regarding claim 33, Jia teaches providing a plurality of metabolites, but does not specify an upper limit of the number of metabolites that may be used. There is no apparent reason why one of ordinary skill in the art would not be able to apply Jia’s teachings to any number of metabolites, including at least 40 metabolites, in order to be able to analyze whatever number of metabolites are required. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the plurality of metabolites comprise at least 40 metabolites, in the normal course of performing analysis of different samples with different numbers of metabolites, including those with at least 40 metabolites.
Allowable Subject Matter
Claim 37 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach wherein the five or more calibrators are non-endogenous, are non-isotopologues, and comprise a nonbiologic.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P MASKELL whose telephone number is (571)270-3210. The examiner can normally be reached M-F 10A-6P.
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/MICHAEL MASKELL/ Primary Examiner, Art Unit 2878 26 June 2026
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