DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I comprising Claims 1-8 in the reply filed on 10/31/2025 is acknowledged. Claims 1-15 are pending in the application. Claims 9-15 are withdrawn from consideration. Claims 1-8 are considered on merits.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 and 6-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a measurement step of performing multiple reaction monitoring (MRM) measurement on a specimen according to at least one of MRM transitions of m/z 246 >187, m/z 246 > 57, m/z 246 > 41, and m/z 246 > 29; and
a processing step of distinguishing between isovalerylcarnitine and pivaloylcarnitine which is an isomer of isovalerylcarnitine in the specimen or determining whether or not C5 acylcarnitine in the specimen includes pivaloylcarnitine, using a measurement result obtained in the measurement step.”.
However, Fig. 2 of the instant specification shows that MRM transitions of m/z 246 > 187 alone cannot distinguish between isovalerylcarnitine and pivaloylcarnitine.
The instant specification also admits that “In the peak intensity pattern illustrated in Fig. 2, there is no clear difference between i-CS and p-CS in an MRM transition of m/z 246.15 >> 187.05.” (par [0066]).
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Therefore, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Allowable Subject Matter
Claim 2-5 are 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 of record does not teach or fairly suggest using the combination of at least two MRM transitions of m/z 246 > 187, m/z 246 > 57, m/z 246 > 41, and m/z 246 > 29, and m/z 246 > 85 to distinguish between isovalerylcarnitine and pivaloylcarnitine in the specimen.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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/XIAOYUN R XU, Ph.D./Primary Examiner, Art Unit 1797