DETAILED ACTION
Notice to Applicant
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. In the Response dated 06/23/2026, Group II (Claims 11-12, 15-20, 22, 24-26, and 28) has been elected.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 12, 16-17, 19, 22, 25-26, and 28 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Per claim 12, it is unclear if the “preferably” and the “more preferably” clauses are intended to be requirements of this claim or if they should be interpreted as optional alternatives. Appropriate correction is required.
Per claim 16, the limitation “the (CR)n-(RC)m circuit” lacks sufficient antecedent basis. Appropriate correction is required. To note, the limitation “a (CR)n-(RC)m circuit” is recited in claim 15, but claim 16 depends on claim 11.
Per claim 17, the limitation “the (CR)n-(RC)m circuit” lacks sufficient antecedent basis. Appropriate correction is required. To note, the limitation “a (CR)n-(RC)m circuit” is recited in claim 15, but claim 17 depends on claim 11.
Per claim 19, the limitation “the output signal” lacks sufficient antecedent basis. Appropriate correction is required. For the purpose of examination, said limitation is interpreted as implying “an output signal.”
Per claim 22, the limitation “the environmental noise” lacks sufficient antecedent basis. Appropriate correction is required. For the purpose of examination, said limitation is interpreted as implying “an environmental noise.”
Per claim 25, it is unclear if the “preferably” clause is intended to be a requirement of this claim or if it should be interpreted as an optional alternative. Appropriate correction is required.
Per claim 25, the limitation “the front-end biosensing stage” lacks sufficient antecedent basis. Appropriate correction is required. For the purpose of examination, said limitation is interpreted as implying “the front-end sensing stage” because the limitation “a front-end sensing stage” is recited in claim 18, from which claim 25 depends.
Per claim 25, it is unclear if the limitation “the biosensor of the front-end amplifier” refers to a biosensor of the differential amplifier pair of biosensors, which is described in claim 18, because the limitation “the front-end amplifier” lacks sufficient antecedent basis. Appropriate correction is required.
Per claim 26, the limitations “the output,” “the front-end biosensing stage,” and “the pulse shaping circuitry” lack sufficient antecedent bases. Appropriate correction is required. For the purpose of examination, said limitations are interpreted as implying “an output,” “the front-end sensing stage,” and “the pulse shaping detection circuit,” respectively.
Per claim 28, the limitations “the predictor,” “the output,” and “the electrical output signal of the front-end biosensing stage” lack sufficient antecedent bases. Appropriate correction is required. For the purpose of examination, said limitations are interpreted as implying “a predictor,” “the electrical signal output,” and “an electrical output signal of a front-end biosensing stage,” respectively.
Per claim 28, it is unclear if the “preferably” clause is intended to be a requirement of this claim or if it should be interpreted as an optional alternative. Appropriate correction is required.
Claim Rejections - 35 USC § 102
5. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
6. Claims 11 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shachar (US 2016/0238553).
Per claim 11, Shachar teaches a system for measuring a concentration of a target analyte in a volume, comprising:
a biosensor (Fig. 1A; bioFET cell 1; ¶118) having a sensing surface and an output terminal, the output terminal configured to change electrical signal based on the response from the sensing surface (The bioFET cell 1 includes a sensing surface comprising nanotubes 14 to which antibodies 20 are bound. An output of the bioFET cell 1 is connected to a log amplifier 802 (Figs. 1A, 4-5, and 9; ¶121 and 131)); and
a pulse shaping detection circuit configured to increase temporal resolution of sensing and to reduce noise in the sensor response during a binding phase (When target biomarkers 21 are captured by the antibodies 20, the binding event causes an impedance change. The log amplifier 802 is configured to widen a dynamic range and a filter 803 coupled to an output of the log amplifier 802 is used for noise filtration (Fig. 5; ¶121 and 131)).
Per claim 28, Shachar teaches the system of claim 11, wherein an electrical signal output of the pulse shaping detection circuit is the predictor of the analyte concentration,
preferably amplitude of the output of the pulse shaping detection circuit is proportional
to the slope of the electrical output signal of the front-end biosensing stage (The impedance change is a predictor of analyte concentration (¶121)).
Claim Rejections - 35 USC § 103
7. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
8. Claims 12, 15, 17 and 24 are rejected under 35 U.S.C. 103 as being obvious over Shachar in view of Flewelling et al. (US 5,046,018 – hereinafter “Flewelling”).
Per claim 12, Shachar does not explicitly teach the system of claim 11, wherein the pulse shaping detection circuit comprises two first order high-pass filters connected in a series having an input and an output, having the input of the series electrically connected to the output terminal, preferably the pulse shaping detection circuit comprising a second order lowpass filter having an input and an output, the input of the second order low-pass filter connected to the output of the series, more preferablv the pulse shaping detection circuit comprising a gain stage having an input and an output, the input of the gain stage connected to the output of the second order low-pass filter.
In contrast, Flewelling teaches an agent gas analyzer configured to measure the concentration of an agent gas comprising a detector 234 that supplies an AGENT signal 412 to processing circuitry comprising two stage high pass filters 526 connected in series to two stage low pass filters 530. The filtering provides a clean sine wave AGENT signal (Figs. 6 and 7A; col. 7, line 62 – col. 8, line 2 and col. 9, lines 36-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shachar such that the pulse shaping detection circuit comprises two first order high-pass filters connected in a series having an input and an output, having the input of the series electrically connected to the output terminal. One of ordinary skill would make such a modification for the purpose of providing a clean signal (Flewelling; col. 9, lines 36-40).
Per claim 15, Shachar does not explicitly teach the system of claim 11, wherein the pulse shaping detection circuit comprises a (CR)n-(RC)m circuit.
In contrast, Flewelling teaches an agent gas analyzer configured to measure the concentration of an agent gas comprising a detector 234 that supplies an AGENT signal 412 to processing circuitry comprising two stage high pass filters 526 connected in series to two stage low pass filters 530. The filtering provides a clean sine wave AGENT signal (Figs. 6 and 7A; col. 7, line 62 – col. 8, line 2 and col. 9, lines 36-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shachar such that the pulse shaping detection circuit comprises a (CR)n-(RC)m circuit. One of ordinary skill would make such a modification for the purpose of providing a clean signal (Flewelling; col. 9, lines 36-40).
Per claim 17, Shachar does not explicitly teach the system of claim 11, wherein the (CR)n-(RC)m circuit comprises a (CR)2-(RC)2.
In contrast, Flewelling teaches an agent gas analyzer configured to measure the concentration of an agent gas comprising a detector 234 that supplies an AGENT signal 412 to processing circuitry comprising two stage high pass filters 526 connected in series to two stage low pass filters 530. The filtering provides a clean sine wave AGENT signal (Figs. 6 and 7A; col. 7, line 62 – col. 8, line 2 and col. 9, lines 36-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shachar such that a (CR)n-(RC)m circuit is provided comprising a (CR)2-(RC)2 circuit. One of ordinary skill would make such a modification for the purpose of providing a clean signal (Flewelling; col. 9, lines 36-40).
Per claim 24, Shachar does not explicitly teach the system of claim 11, wherein the pulse shaping detection circuit comprises a plurality of amplification stages along a signal chain.
In contrast, Flewelling teaches an agent gas analyzer configured to measure the concentration of an agent gas comprising a detector 234 that outputs a signal to processing circuitry comprising a preamplifier 409 and a variable gain amplifier 512 (Figs. 6 and 7A; col. 7, line 62 – col. 8, line 2 and col. 9, lines 22-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shachar such that the pulse shaping detection circuit comprises a plurality of amplification stages along a signal chain. One of ordinary skill would make such a modification for the purpose supplying suitable signals to filter stages (Flewelling; col. 7, line 62 – col. 8, line 2 and col. 9, lines 22-40).
9. Claim 16 is rejected under 35 U.S.C. 103 as being obvious over Shachar in view of Flewelling, in further view of Outsuka et al. (US 4,072,594 – hereinafter “Outsuka”).
Per claim 16, Shachar does not explicitly teach the system of claim 11, wherein the (CR)n-(RC)m circuit is configured for use in pulse-shaping of signals with time constants of 1 to 1000 sec-1.
In contrast, Flewelling teaches an agent gas analyzer configured to measure the concentration of an agent gas comprising a detector 234 that supplies an AGENT signal 412 to processing circuitry comprising two stage high pass filters 526 connected in series to two stage low pass filters 530. The filtering provides a clean sine wave AGENT signal (Figs. 6 and 7A; col. 7, line 62 – col. 8, line 2 and col. 9, lines 36-40).
Furthermore, Outsuka teaches a device for analyzing small quantities of metal ions at high accuracies comprising a filter circuit having a time constant from 0.01 to 0.1 second (Abstract; col. 7, lines 24-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shachar such that a (CR)n-(RC)m circuit is provided and configured for use in pulse-shaping of signals with time constants of 1 to 1000 sec-1. One of ordinary skill would make such a modification for the purpose of providing a clean signal (Flewelling; col. 9, lines 36-40) to enable the detection of small quantities of a component to be analyzed at high accuracy (Outsuka; Abstract).
10. Claims 18-20 and 25-26 are rejected under 35 U.S.C. 103 as being obvious over Shachar in view of Levon et al. (US 2005/0230271 – hereinafter “Levon”).
Per claim 18, Shachar does not explicitly teach the system of claim 11, wherein a front-end sensing stage of the pulse shaping detection circuit comprises a differential amplifier pair of biosensors.
In contrast, Levon teaches a floating gate field effect transistor (FGFET) system for chemical and/or biological sensing comprising a differential amplifier-based read-out circuit 900. The circuit 900 comprises a differential amplifier 950 configured to output a signal representing a threshold voltage difference between an FGFET 910 with sensing material and an FGFET 920 without sensing material (Fig. 9; ¶55-56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shachar such that a front-end sensing stage of the pulse shaping detection circuit comprises a differential amplifier pair of biosensors. One of ordinary skill would make such a modification for the purpose of determining the concentration of a target material based on the difference between a signal from a device with sensing material and a signal from a device without sensing material (Levon; ¶55-56).
Per claim 19, Shachar in view of Levon teaches the system of claim 18, wherein the output signal of the front-end sensing stage feeds a signal chain of the pulse shaping detection circuit (In the system of Shachar in view of Levon, the differential amplifier pair of biosensors would feed a signal chain of the pulse shaping detection circuit (Levon; Fig. 9)).
Per claim 20, Shachar in view of Levon teaches the system of claim 18, wherein one biosensor of the differential amplifier pair has capturing probes on its surface or wherein one biosensor of the differential amplifier pair does not have capturing probes on its surface (In the system of Shachar in view of Levon, one biosensor would have capturing probes on its surface and the other biosensor would not have capturing probes on its surface (Levon; ¶55-56)).
Per claim 25, Shachar in view of Levon teaches the system of claim 18, wherein the front-end biosensing stage is a single-stage amplifier, preferablv the biosensor of the front-end amplifier has capturing probes on its surface (In the system of Shachar in view of Levon, a single-stage amplifier is provided (Levon; ¶55-56)).
Per claim 26, Shachar in view of Levon teaches the system of claim 18, wherein the output of the front-end biosensing stage feeds a signal chain of the pulse shaping circuitry (In the system of Shachar in view of Levon, the output of the differential amplifier pair of biosensors would feed a signal chain of the pulse shaping detection circuit (Levon; Fig. 9)).
11. Claim 22 is rejected under 35 U.S.C. 103 as being obvious over Shachar in view of Levon, in further view of Tsukada (US 2011/0169057).
Per claim 22, Shachar in view of Levon does not explicitly teach the system of claim 18, wherein the differential amplifier pair of biosensors cancels the electrical signals due to non-specific binding or wherein the differential amplifier pair of biosensors cancels the environmental noise.
In contrast, Tsukada teaches a gas sensor 30 comprising a catalytic metal gate transistor 25 and a non-catalytic metal gate transistor 26. A differential amplifier 21 obtains a difference between the outputs of the transistors 25 and 26 to compensate for electromagnetic noise (¶61).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Shachar in view of Levon such that the differential amplifier pair of biosensors cancels the electrical signals due to non-specific binding or wherein the differential amplifier pair of biosensors cancels the environmental noise. One of ordinary skill would make such a modification for the purpose of obtaining a response without the influence of an environmental disturbance (Tsukada; ¶61).
Pertinent Prior Art
12. Bock et al. – US 2007/0264634
This document discloses a nano-chem-FET wherein fluctuation analysis of nanosensor data is used to provide the concentration of an analyte. The concentration of the analyte may be obtained from the rate of new bindings (¶85).
Conclusion
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAS A. SANGHERA whose telephone number is (571)272-4787. The examiner can normally be reached M-Th, alt. Fri, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, WALTER LINDSAY can be reached at (571) 272-1674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAS A SANGHERA/Primary Examiner, Art Unit 2852
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