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 .
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 20 August 2026 has been entered.
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 48 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.
Claim 48 recites the limitation “exposing the analyte sensor of claim 51 to interstitial fluid” in line 3 of the claim. It is unclear if “interstitial fluid” is meant to refer to the user’s interstitial fluid, as introduced in claim 51, or if it may refer to a different interstitial fluid. The limitation is interpreted as referring to the user’s interstitial fluid and it is recommended that the claim be amended to “exposing the analyte sensor of claim 51 to the user’s interstitial fluid” or “exposing the analyte sensor of claim 51 to the interstitial fluid”.
Allowable Subject Matter
Claims 5, 46-4 allowed.
Claim 48 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance:
The prior art of the record fails to teach and/or fairly suggest, in combination with all other recited limitations, “a ketones-responsive active area for detecting ketones, the ketones-responsive active area disposed directly upon a surface of the first working electrode, the ketones-responsive active area comprising a first polymer and a cofactor” of claim 51.
The most pertinent prior art of the record, McColl (WO 2011030093—previously cited) fails to teach the above limitation, wherein the ketones-responsive active area has been clarified to be disposed directly upon the surface of the first working electrode, as argued by the applicant in page 12 of the remarks dated 06 August 2025 as an interpretation of McColl which includes the cofactor in the ketones-responsive active area would not be disposed directly upon the surface of the first working electrode, nor does McColl adequately suggest making this modification.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/Examiner, Art Unit 3791
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