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.
Claims 1 and associated dependent claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as the specification does not adequately enable and does not clearly provide written description support for the limitation of “applying a plurality of voltage pulses to a reference electrode.” The specification recites this concept in several places, including statements that a differential pulse sequence is applied to a reference electrode and that current pulses are applied to the reference electrode directly [e.g., 0028, 29]. However, the disclosure does not adequately explain how this arrangement is technically operative in an electrochemical system -- the reference electrode is intended to provide a stable reference potential and is ordinarily not driven with pulsed current or voltage excitation [see at least previously cited “Schmidt”, US Patent 4500391, col.1, ll.56-67]. The specification does not sufficiently describe at least:
how the reference electrode can be pulsed without becoming polarized;
how reference-potential drift is avoided;
how accurate voltammetric measurement is maintained under such operation; and
what operational steps permit the reference electrode to continue functioning as a stable reference under pulse excitation.
Because the disclosure provides only conclusory statements, without sufficient technical teaching or operational detail, the full scope of the limitation is not enabled without undue experimentation. See In re Wands, 858 F.2d 731 (Fed. Cir. 1988); MPEP 2164.
To the extent the claims are interpreted as requiring a pulsed reference electrode, the specification also fails to reasonably convey possession of that subject matter in a technically operative form. The disclosure uses the term “reference electrode,” but does not reconcile that term with standard voltammetric architecture or explain whether the term is being used in a nonstandard sense.
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 1 and associated dependent claims 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. It is not clear what is being selected regarding “a second volage window associated with the second voltage window” as it seems circular.
Furthermore, the limitation “applying a plurality of voltage pulses to a reference electrode” fails to particularly point out and distinctly claim the subject matter regarded as the invention. The phrase is ambiguous in view of discussion above regarding voltammetry -- the reference electrode is used as a potential reference, while current-carrying excitation is typically applied through a working electrode and counter electrode arrangement. Thus, the claim language is unclear as to whether/how the reference electrode is being used in a nonstandard role as a drive electrode. This ambiguity renders the metes and bounds of the claim uncertain, because a person of ordinary skill in the art would not be able to determine with reasonable certainty what structure or operation falls within the claim scope.
Response to Arguments
Applicant’s arguments submitted 4/2/26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Regarding the “different voltage windows associated [with] different biochemicals”, Examiner submits that different electroactive species naturally have different oxidation potentials – a natural phenomenon. Therefore, differential pulse voltammetry prior arts such as “Gao” [previously cited US Publication 20200359942] naturally have different defined range [voltage window] associated with different target molecules that oxidize at different potentials – it would be obvious if not implicit to select a broadly claimed voltage window in order to properly analyze particular molecules or biochemical targets.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tse Chen whose telephone number is (571)272-3672. The examiner can normally be reached M-F 7-3 EST.
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/TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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