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 .
Status of the Rejections pending since the
Final Office Action mailed on August 27, 2025
The rejection of claims 1, 3-8, and 10-13 under 35 U.S.C. 112(a), lack of enablement, is maintained.
Response to Arguments
Applicant's arguments filed November 26, 20251 have been fully considered but they are not persuasive. Applicant has not directly addressed the rejection under
35 U.S.C. 112(a) and only indirectly addressed one of the issues, unpersuasively, raised therein. In particular, note that the following issues have not been addressed (excerpted from pages 10-14 of the Final Office Action)
(F) The amount of direction provided by the inventor
Applicant does provide direction, even detailed direction, such as on as-filed specification pages 18-19, for some aspects of the charging current correction procedure; however, other aspects are passed over or vaguely or ambiguously described or even inconsistent with the claims. In particular, stepping now through the detailed description on pages 18-19,
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“[A]mbient voltage” appears to be term unique to Applicant, yet it is not defined.
“By setting V to peakV” – there is no indication as under what circumstances this “setting” is reasonable.
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So, in the direction of the specification the background is subtracted from the voltammogram before the second derivative is calculated. However, claim 1 recites
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Similarly in clam 8,
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That is, in the claims the background is subtracted from the voltammogram after the second derivative is calculated, from the Second- Derivative-based Background Removal, in fact, but in the in the direction of the specification the background is subtracted from the voltammogram before the second derivative is calculated.
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There is no explanation of how this applying of SDBR is applied to a voltammogram. Also, why does the sentence use the phrase “may represent [italicizing by the Examiner]”?
It is not clear whether this “applying” is what is meant by “process the FSCV data as the faradaic current-type Second- Derivative-based Background Removal (SDBR) data” in claim 1 and similarly in claim 8 “processing, by a data processor, the FSCV data as the faradaic current-type Second- Derivative-based Background Removal (SDBR) data”. In any event “applied” in regard to Equation 3, “process” in claim 1, and “processing” in claim 8 are vague as to what they each entail.
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It is not clear what the second derivative of the modeled voltammogram is set to.
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This “confirmation” does not seem readily apparent to the Examiner.
Last, there is an indefiniteness issue, which is discussed in the rejections under 35 U.S.C. 112(b) below, namely, what is meant by “a negative value” and how to it is to be used as claimed, that make implementing the claimed data processor of claim 1 and performing the processing step of claim 9 challenging.
Last, Applicant’s After-Final Amendment, page 7, states,
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However, in the equation relied upon by Applicant VoltgramBS (V, t) is not negative, but its second derivative is. Also, it is not clear what this processing of the second derivative entails. There is no processing of the second derivative indicated in the equation.
Claim Rejections - 35 USC § 112
Note that dependent claims will have the deficiencies of base and intervening claims.
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, 3-8, and 10-132 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 inventors, at the time the application was filed, had possession of the claimed invention.
Applicant's proposed amendments raise the issue of new matter. Namely, in
claim 1, line 11, "applying a second derivative for a peak voltage is to be replaced with – processing a second derivative for a peak voltage--; in claim 1, last two lines, "applying the second derivative for the voltage of the extracted individual voltammogram... " is to be replaced with – processing the second derivative with a negative value for the voltage of the extracted voltammogram --; in claim 8, line 12, "applying a second derivative for a peak voltage " is to be replaced with -- processing a --; and in claim 8, last two lines, "applying the second derivative for a peak voltage derivative for the voltage of the extracted individual voltammogram is to be replaced with – processing the second derivative with a negative value for the voltage of the extracted voltammogram –.
The Examiner has found no support for either replacing "applying" with "processing" as sought or for the new phrase "the second derivative with a negative value for the voltage" nor as Applicant indicated how “processing” is meant to be different form “applying”. Also, Applicant argues that the term "negative value" in the claims "refers to the negative value applied to the differential function in Equation 3. See page 7 of Applicant's After-Final Amendment. However, Applicant's specification only states, "multiplying the extracted individual voltammogram by a negative value after the second derivative for the voltage of the extracted individual voltammogram. [underlining by the Examiner]" See Applicant's pre-grant publication (US 20230375502 A1) paragraphs [0031], [0038], [0068], [0083], [0086]. [0095], [0119], and [0156].
Claims 1, 3-8, and 10-13 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Independent claim 1 requires “a data processor configured to extract the individual voltammogram in which the faradaic current and the capacitive charge current are reflected together for each scan by the background subtraction in relation to a peak voltage generated based on neurotransmitter injection in the FSCV data and convert the FSCV data to a faradaic current-type Second-Derivative-based Background Removal (SDBR) data, in which the capacitive charge current is subtracted from the FSCV data, by applying processing a second derivative for a peak voltage of an individual voltammogram generated for each scan by background subtraction in the FSCV data; . . . .” Independent claim 8 requires, analogously, “extracting, by a data processor, the individual voltammogram in which the faradaic current and the capacitive charge current are reflected together for each scan by the background subtraction in relation to the peak voltage generated based on neurotransmitter injection in the FSCV data; converting, by the data processor, the FSCV data to a faradaic current-type Second- Derivative-based Background Removal (SDBR) data, in which the capacitive charge current is subtracted from the FSCV data, by applying processing a second derivative for a peak voltage of an individual voltammogram generated for each scan by background subtraction in the FSCV data; . . . .”
One of ordinary skill in the art would not know how to appropriately configure a data processor as required by claim 1 or how to implement the extracting and converting of claim 8.
Addressing now the Wands undue experimentation factors (MPEP 2164.01(a))3
(A) The breadth of the claims
The claims are narrow in scope as the analyte is limited to a neurotransmitter and the measurement technique is Fast-Scan Cyclic Voltammetry (FSCV).
(B) The nature of the invention
Independent claim 1 is for a neurotransmitter concentration measuring apparatus, comprising: a data collector configured to collect FSCV data. Independent claim 8 is for a neurotransmitter concentration measurement method, comprising: collecting, by a data collector, FSCV data.
(C) The state of the prior art
The use of FSCV to measure the concentration of neurotransmitters, such as dopamine, was known in the art at the time of the effective filing date of the application. See, for example, John et al., “Chapter 4 Fast Scan Cyclic Voltammetry of Dopamine and Serotonin in Mouse Brain Slices,” Michael AC, Borland LM, editors. Electrochemical Methods for Neuroscience. Boca Raton (FL): CRC Press/Taylor & Francis; 2007. Also see Puthongkham et al., “ Recent Advances in Fast-Scan Cyclic Voltammetry,” Analyst. 2020 February 17; 145(4): 1087–1102 (hereafter “Puthongkham”).
Additionally, the problem of charging current in FSCV in particular and cyclic voltammetry in general was known in the art. One type of solution to this problem commonly does involve background subtraction, but it does not involve processing the FSCV data as the faradaic current-type Second Derivative-based Background Removal (SDBR) data as claimed. See, for example, in Puthongkham the last paragraph on page 1088, bridging to page 1089; Jang et al. US 2021/0341412 A1 the title, Abstract, and paragraphs [0079] and [0080]; US 20120247978 A1 paragraphs [0033] and [0075]; and US 20030015422 A1 paragraphs [0066].
(D) The level of one of ordinary skill
One of ordinary skill in this art would be hold an advanced degree in engineering or a science such as biology, chemistry, or clinical chemistry, and would have an understanding of electrochemical measuring techniques.
(E) The level of predictability in the art
There is a high level of predictability in the art about using FSCV to measure the concentration of neurotransmitters (such as dopamine), particularly in regard to the undesirable effect of charging current. For example, Puthongkham discloses, on
page 1088, bridging to page 1089,
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Also, on page 1089,
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(F) The amount of direction provided by the inventor
Applicant does provide direction, even detailed direction, such as on as-filed specification pages 18-19, for some aspects of the charging current correction procedure; however, other aspects are passed over or vaguely or ambiguously described or even inconsistent with the claims. In particular, stepping now through the detailed description on pages 18-19,
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“[A]mbient voltage” appears to be term unique to Applicant, yet it is not defined.
“By setting V to peakV” – there is no indication as under what circumstances this “setting” is reasonable.
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So, in the direction of the specification the background is subtracted from the voltammogram before the second derivative is calculated. However, claim 1 recites
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Similarly in clam 8,
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That is, in the claims the background is subtracted from the voltammogram after the second derivative is calculated, from the Second- Derivative-based Background Removal, in fact, but in the in the direction of the specification the background is subtracted from the voltammogram before the second derivative is calculated.
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There is no explanation of how this applying of SDBR is applied to a voltammogram. Also, why does the sentence use the phrase “may represent [italicizing by the Examiner]”?
It is not clear whether this “applying” is what is meant by “process the FSCV data as the faradaic current-type Second- Derivative-based Background Removal (SDBR) data” in claim 1 and similarly in claim 8 “processing, by a data processor, the FSCV data as the faradaic current-type Second- Derivative-based Background Removal (SDBR) data”. In any event “applied” in regard to Equation 3, “process” in claim 1, and “processing” in claim 8 are vague as to what they each entail.
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It is not clear what the second derivative of the modeled voltammogram is set to.
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This “confirmation” does not seem readily apparent to the Examiner.
Last, there are several indefiniteness issues, which are discussed in the rejections under 35 U.S.C. 112(b) below. Most importantly, what is meant by “a negative value” as used in the phrase “processing a second derivative with a negative value”. These 35 U.S.C. 112(b) indefiniteness issues further make implementing the claimed data processor of claim 1 and performing the processing steps of claims 1 and 8 challenging.
(G) The existence of working examples
There are working examples, which are discussed on pages 22-29 of the as-filed specification; however, only the results of the data processing are discussed not how FSCV data was processed.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure
In light of the above discussion of the Wands factors the quantity of experimentation needed to make or use the invention based on the content of the disclosure is undue.
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, 3-8, and 10-13 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:
a) claim 1, lines 6-7, requires “a data processor configured to extract the individual voltammogram in which the faradaic current and the capacitive charge current are reflected together for each scan by the background subtraction in relation to a peak voltage generated based on neurotransmitter injection in the FSCV data . . . . [italicizing by the Examiner]” It is not clear how the phrase “reflected together” is being used here. What is meant by reflecting currents?
b) claim 1 recites the limitation "the background subtraction" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim.
c) claim 1, limes 6-9, recites the limitation " a data processor configured to extract the individual voltammogram in which the faradaic current and the capacitive charge current are reflected together for each scan by the background subtraction in relation to a peak voltage generated based on neurotransmitter injection in the FSCV data . . . . [italicizing by the Examiner]". The phrase “based on neurotransmitter injection in the FSCV data” is not clear. What does it mean to inject neurotransmitter (a biochemical) into FSCV data (numeric information)?
d) in claim 1, last four lines of the claim, what is meant by “and converts the FSCV data to the SDBR data by quantifying a curvature of a neurotransmitter peak by multiplying the extracted individual voltammogram by processing the second derivative with a negative value for the voltage of the extracted individual voltammogram. [italicizing by the Examiner]” Also, what is the scope of a generic “negative value for the voltage of the extracted individual voltammogram”? What is a negative value” intended to be in practice? An example would be helpful. The Examiner acknowledges here the following form Applicant’s After-Final Amendment, page 7,
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However, in the equation relied upon by Applicant VoltgramBS (V, t) is not negative, but its second derivative is. Also, it is not clear what this processing of the second derivative entails. There is no processing of the second derivative indicated in the equation.
e) claim 1, lines 11-12, requires “by processing a second derivative for a peak voltage of an individual voltammogram generated for each scan by background subtraction in the FSCV data; . . . . [italicizing by the Examiner]” It is not clear what this processing entails, particularly how background subtraction may be used with or upon the second derivative.
f) claim 3 requires “wherein the extracted individual voltammogram comprises a phasic measurement result in relation to measuring a concentration of the neurotransmitter, and the SDBR data comprises the phasic measurement result and tonic measurement result in relation to measuring a concentration of the neurotransmitter. [italicizing by the Examiner]” What is meant by “a phasic measurement”? Does it mean a measurement of a phase change in an electrical signal? If Applicant is being his own lexicographer, please heed MPEP 2173.05(a).
g) Claim 3 recites the limitation " and the SDBR data comprises the phasic measurement result and tonic measurement result " in line 4. There is insufficient antecedent basis for this limitation (“the . . . . tonic measurement result”) in the claim.
h) claim 3 requires “wherein the extracted individual voltammogram comprises a phasic measurement result in relation to measuring a concentration of the neurotransmitter, and the SDBR data comprises the phasic measurement result and tonic measurement result in relation to measuring a concentration of the neurotransmitter. [italicizing by the Examiner]” What is meant by “a tonic measurement”? If Applicant is being his own lexicographer, please heed MPEP 2173.05(a).
i) claim 8, lines 6-9, requires “extracting, by a data processor, the individual voltammogram in which the faradaic current and the capacitive charge current are reflected together for each scan by the background subtraction in relation to a peak voltage generated based on neurotransmitter injection in the FSCV data . . . . [italicizing by the Examiner]” It is not clear how the phrase “reflected together” is being used here. What is meant by reflecting currents?
j) claim 8 recites the limitation "the background subtraction" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim.
k) claim 8 recites, in lines 6-9, the limitation "extracting, by a data processor, the individual voltammogram in which the faradaic current and the capacitive charge current are reflected together for each scan by the background subtraction in relation to a peak voltage generated based on neurotransmitter injection in the FSCV data . . . . [italicizing by the Examiner]". The phrase “based on neurotransmitter injection in the FSCV data” is not clear. What does it mean to inject neurotransmitter (a biochemical) into FSCV data (numeric information)?
l) in independent claim 8, last four lines of the claim, what is meant by “and converts the FSCV data to the SDBR data by quantifying a curvature of a neurotransmitter peak by multiplying the extracted individual voltammogram by processing the second derivative with a negative value for the voltage of the extracted individual voltammogram. [italicizing by the Examiner]” Also, what is the scope of a generic “negative value for the voltage of the extracted individual voltammogram”? What is a negative value” intended to be in practice? An example would be helpful. The Examiner acknowledges here the following form Applicant’s After-Final Amendment, page 7,
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However, in the equation relied upon by Applicant VoltgramBS (V, t) is not negative, but its second derivative is. Also, it is not clear what this processing of the second derivative entails. There is no processing of the second derivative indicated in the equation.
m) claim 8, lines 12-14, requires “by processing a second derivative for a peak voltage of an individual voltammogram generated for each scan by background subtraction in the FSCV data; . . . . [italicizing by the Examiner]” It is not clear what this processing entails, particularly how background subtraction may be used with or upon the second derivative.
n) claim 10 requires “wherein the extracted individual voltammogram comprises a phasic measurement result in relation to measuring a concentration of the neurotransmitter, and the SDBR data comprises the phasic measurement result and tonic measurement result in relation to measuring a concentration of the neurotransmitter. [italicizing by the Examiner]” What is meant by “a phasic measurement”? Does it mean a measurement of a phase change in an electrical signal? If Applicant is being his own lexicographer, please heed MPEP 2173.05(a).
o) Claim 10 recites the limitation " and the SDBR data comprises the phasic measurement result and tonic measurement result " in line 4. There is insufficient antecedent basis for this limitation (“the . . . . tonic measurement result”) in the claim.
p) claim 8 requires “wherein the extracted individual voltammogram comprises a phasic measurement result in relation to measuring a concentration of the neurotransmitter, and the SDBR data comprises the phasic measurement result and tonic measurement result in relation to measuring a concentration of the neurotransmitter. [italicizing by the Examiner]” What is meant by “a tonic measurement”? If Applicant is being his own lexicographer, please heed MPEP 2173.05(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER STEPHAN NOGUEROLA whose telephone number is (571)272-1343. The examiner can normally be reached on Monday - Friday 9:00AM-5:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached on 571 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795
1 Applicant’s Request for Continued Examination filed December 23, 2025 does not include new arguments or claim amendments relative to the After-Final Amendment of November 26, 2025.
2 As presented in the After-Final Amendment of November 26, 2025.
3 As independent claim 1 and independent claim 8 are analogous, the former being for an apparatus that can perform the method of claim 8 and the latter being for a method that performed the stated functions for the apparatus of claim 1, the rejections of both claims 1 and 8 done together.