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 .
An amendment and RCE filed 5/22/2026 are acknowledged. Claims 1, 2, 4, 5, and 9 are pending. Claims 3 and 6-8 are cancelled. Claim 9 is new. Claims 1, 2, 4, 5, and 9 are considered on the merits below.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/22/2026 has been entered.
Response to Amendment
Applicant's amendments, filed 5/22/2026, with respect to the objection to the drawings and 101 rejection, have been fully satisfied and withdrawn.
In response to the applicant's amendments, the grounds of rejection for claims 1, 2, 4, 5, and 9 are new compared to the previous action.
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.
Claims 1, 2, 4, 5, and 9 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.
Regarding claim 1, the limitation “simultaneously quantifying” is new matter. Looking to the instant specification and drawings, there is evidence that both PhIP and MeIQx are quantified, but nothing to indicate “simultaneously”. Thus the amendment fails to comply with the written description requirement.
Dependent claims follow the same reasoning.
Response to Arguments
Applicant’s arguments with respect to claims 1, 2, 4, 5, and 9 have been considered but are moot because the arguments do not apply to the current rejection.
Regarding the 101 rejection, the amendment to the claims to include specific parameters of hydrolyzing the biological sample, as well as requiring an LC/MS/MS for quantification, are sufficient to overcome the rejection as it now requires the quantification to be more than an mental step.
Regarding the 102 rejection, the amendments to the claims to include “simultaneously quantifying” are sufficient to overcome the prior art rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R BERKELEY whose telephone number is (571)272-9831. The examiner can normally be reached M-Th 9-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
/EMILY R. BERKELEY/
Examiner
Art Unit 1796
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