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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/28/2025 has been entered.
Status of the Claims
Claims 5 and 13-14 and have been amended and claim 24 is new. Claims 20-23 have been withdrawn previously, and claims 5-11, 13-14, 18-19, and 24 are examined herein.
Status of the Rejection
New grounds of claim objection are necessitated by the amendment.
All 35 U.S.C. § 103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment.
New grounds of rejection under 35 U.S.C. § 103 are necessitated by the amendment as outlined below.
Claim Objections
Claim 5 is objected to because of the following informalities:
In claim 5 line 12, “a) a single first electrode and wherein” should be amended to -- a) a single first electrode, [[and]] wherein-- (comma inserted after “electrode”).
In claim 5 lines 15, “b) two reference electrodes wherein” should be amended to --b) two reference electrodes, wherein -- (comma inserted after “electrodes”).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wei et al. (“Fuel Cell Virus Sensor Using Virus Capture within Antibody-Coated Nanochannels,” 2013, Analytical Chemistry, vol. 85(3), pgs. 1350-1357).
Regarding claim 24, Wei teaches a device for detecting the presence or absence of a chemical or biological target within a sample (a fuel cell sensor system for direct detection of unlabeled virus particles [pg. 1350, ABSTRACT]), the device comprising:
an electrochemical cell comprising a first electrode module (auxiliary and reference electrodes in Scheme 1B [pg. 1351, col. 1, para. 1]), a second electrode (platinum PB-nt membrane as the sensing electrode in Scheme 1A-1B [pg. 1351, col. 1, para. 1]) and an electrolyte container configured to immerse both the first electrode module and the second electrode in an electrolyte solution (two-compartment cell in Scheme 1B [pg. 1351, col. 1, para. 1]), wherein the second electrode is functionalized with an antibody (all PB-nt membranes were immobilized with antibody [pg. 1351, col. 2, para. 3]);
an electronic component provided between the first electrode module and the second electrode (current meter “A” in Scheme 1B); and
an electrometer configured to measure a potential difference between the first electrode module and the second electrode (potentiostat “V” in Scheme 1B measures the voltage difference between the PB-nt membrane working electrode and the first electrode module which includes the platinum mesh counter electrode and reference electrode [pg. 1352, col. 1, para. 2]),
wherein the first electrode module comprises a reference electrode (the green reference electrode in Scheme 1B [pg. 1351, col. 1, para. 1]) and an additional electrode (the gray auxiliary electrode in Scheme 1B [pg. 1351, col. 1, para. 1]).
The limitation “that undergoes a change in potential due to the formation of an electroactive species” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Wei teaches an electrode that is configured to perform the functional limitations above (water oxidation occurs at the auxiliary electrode in Scheme 1B, such that an electroactive species donates an electron at the electrode and a change in potential occurs [pg. 1351, col. 1, para. 1]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 5, 8-9, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gu (US 20140048424 A1) in view of Gao et al. (US 20060160100 A1).
Regarding claim 5, Gu teaches a device for detecting the presence or absence of a chemical or biological target within a sample (a sensor for detecting a biofilm in Fig. 9A [0099]), the device comprising:
an electrochemical cell comprising a first electrode module (anode in Fig. 9A), a second electrode (cathode in Fig. 9A) and an electrolyte container configured to immerse both the first electrode module and the second electrode in an electrolyte solution (the anode and cathode are attached to a housing that connects to a storage tank to immerse the electrodes in a medium, which may be an electrolytic buffer [0054, 0099]), wherein the second electrode is functionalized (the cathode is partially coated by a biofilm in Fig. 9A [0100]);
an electronic component provided between the first electrode module and the second electrode (the resistor “R” in Fig. 9A is connected to the anode and cathode [0061]); and
an electrometer configured to measure the potential difference between the first electrode module and the second electrode (the voltmeter/ammeter parallel to the resistor in Fig. 9A measures the voltage between the electrodes [0061, 0100]),
wherein the first electrode module comprises:
a) a single first electrode and wherein the electronic component and electrometer are provided between the single first electrode and the second electrode (the anode comprises a single electrode, wherein the resistor and voltmeter/ammeter are connected between the anode and cathode in Fig. 9A).
Gu is silent to the limitation wherein the second electrode is functionalized with an antibody.
Gao teaches a device for detecting the presence or absence of a chemical or biological target within a sample (a device for an electrochemical protein assay [0015]), the device comprising: an electrochemical cell (electrochemical cell 2 in Fig. 1 [0029]) comprising a first electrode module (working electrode 10, which is a cathode [0029]), a second electrode (reference electrode 6, which is an anode [0029]) and an electrolyte container configured to immerse both the first electrode module and the second electrode in an electrolyte solution (solution 7 contains an electrolyte to cover the surfaces of electrodes 6 and 10 [0029]), wherein the second electrode is functionalized with an antibody (working electrode 10 is functionalized with capture antibody 24 in Fig. 2 [0038]). Gao further teaches that the working electrode functionalized with an antibody enables specific detection of a target protein [0014-0015].
Gu and Gao are both considered analogous to the claimed invention because they are in the same field of electrochemical devices for detecting a biological target. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the cathode in Gu with an antibody-functionalized cathode, as taught in Gao, because the substitution would enable specific detection of a target protein [0014-0015 in Gao]. Furthermore, the claimed device differs from Gu by the substitution of some components (the cathode in Gu) with other components (the antibody-functionalized cathode in Gao) whose functions were known in the prior art. One of ordinary skill in the art could substitute one known element for another to yield predictable results (MPEP 2143(I)(B)).
Regarding claim 8, modified Gu teaches the device according to claim 5, and further teaches wherein the antibody is functionalized with a biological recognition element (as stated in the rejection of claim 5 above, the cathode from Gao is substituted for the cathode in Gu. The antibody functionalized to the cathode in Gao is further functionalized with a biological recognition element [detection antibody 48 in Fig. 3, para. 0041]).
Regarding claim 9, modified Gu teaches the device according to claim 5, wherein the second electrode is made from gold (as stated in the rejection of claim 5 above, the cathode from Gao is substituted for the cathode in Gu. The cathode in Gu comprises gold [0035]).
Regarding claim 13, modified Gu teaches the device according to claim 5, and Gu further teaches wherein the first electrode is made from silver (the anode is silver/silver sulfide [0100]).
Regarding claim 14, modified Gu teaches the device according to claim 5, but is silent to the limitation wherein the first electrode is coated in silver chloride.
Gao teaches that silver/silver chloride is an appropriate reference anode material for the sensing of proteins via an antibody-based assay [0060].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the silver sulfide anode coating in modified Gu with silver chloride, as taught in Gao, because the substitution would generate an appropriate reference anode for the sensing of proteins via an antibody-based assay [0060 in Gao]. Furthermore, the claimed device differs from modified Gu by the substitution of some components (the silver sulfide anode coating in modified Gu) with other components (the silver chloride anode coating in Gao) whose functions were known in the prior art. One of ordinary skill in the art could substitute one known element for another to yield predictable results (MPEP 2143(I)(B)).
Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (MPEP 2144.07).
Claims 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gu in view of Gao, as applied to claim 5 above, and further in view of Kuphaldt (“Lessons in Electric Circuits: Volume I – DC,” 2006, vol. 1, 5th ed., pgs. 251-258).
Regarding claim 6, modified Gu teaches the device according to claim 5, but is silent to the limitation wherein the electronic component is a variable resistor.
Kuphaldt teaches a variable resistance (the range selector switch switches between different resistors R1-R4 [pg. 254, para. 3]) connected in parallel with an ammeter (multirange ammeter [pg. 254, second figure]). Kuphaldt further teaches that a current meter connected in parallel with a variable resistance widens the applicable range of the meter [pg. 254, para. 3].
Modified Gu and Kuphaldt are both considered analogous to the claimed invention because they are in the same field of sensor circuits. 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 resistor in modified Gu by implementing a range selector that switches between variable resistances, as taught in Kuphaldt, such that the electronic component is a variable resistor, since this would widen the applicable range of the connected ammeter [pg. 254, para. 3 in Kuphaldt]. Furthermore, Kuphaldt teaches the claimed improvement as a known technique that is applicable to the base device in modified Gu. One skilled in the art could have applied the variable resistor in Kuphaldt in the same way to the base device in modified Gu, yielding predictable results (MPEP 2143(I)(D)).
Regarding claim 18, modified Gu teaches the device according to claim 6, and further teaches wherein the electronic component is a switched group of resistors (as stated in the rejection of claim 6 above, the electronic component includes a range selector that switches between a group of resistors [pg. 254, para. 3 in Kuphaldt]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gu in view of Gao and Kuphaldt, as applied to claim 6 above, and further in view of Lee (US 20060263254 A1).
Regarding claim 7, modified Gu teaches the device according to claim 6, but is silent to the device further comprising a memory configured to store predetermined threshold data, wherein the memory further comprises data for different values of the resistance of the electronic component.
Lee teaches a gas sensor with an electronic component with a variable resistance (the sensing material has a resistance that changes based on the manufacturing and sensing conditions [0010-0011]). The sensor also includes a memory (control, memory, and calculation units are linked to sensing unit 38 in Fig. 3) configured to store predetermined threshold data (a lookup table stored in a third memory for determining concentration based on stored voltages [0030]), wherein the memory further comprises data for different values of the resistance of the electronic component (reference voltage values corresponding to resistance values of the sensing material with respect to a reference gas are stored in a first memory, and second voltage values corresponding to changed resistance values of the sensing material reacting with the target gas are stored in a second memory [0014]). Lee further teaches that this memory enables the sensor to automatically calculate and output an estimate of the analyte concentration [0027].
Modified Gu and Lee are both considered analogous to the claimed invention because they are in the same field of sensors. 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 device in modified Gu by providing a memory configured to store predetermined threshold data, wherein the memory further comprises data for different values of the resistance of the electronic component, as taught by Lee, because it would enable the sensor to automatically calculate and output an estimate of the analyte concentration [0027 in Lee]. Furthermore, the claimed device only differs from the prior art by the actual lack of combination of the device in modified Gu with the memory in Lee. One of ordinary skill in the art could combine the elements by known methods, with each element merely performing the same function as it does separately, to yield predictable results (MPEP 2143(I)(A)).
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gu in view of Gao, as applied to claim 5 above, and further in view of Astley et al. (US 20160223490 A1).
Regarding claim 19, modified Gu teaches the device according to claim 5, but is silent to the device further comprising: a memory configured to store predetermined threshold data; and a processor configured to compare the measured potential difference and the stored threshold data to confirm the presence or absence of the chemical or biological target within the sample.
Astley teaches an apparatus for determining the presence and/or amount of a target analyte, including a measurement circuit that comprises a potentiostat [0017]; a memory configured to store predetermined threshold data (storage medium 1020 in Fig. 10 stores predetermined measurements [0074]); and a processor configured to compare the measured potential difference and the stored threshold data to confirm the presence or absence of the chemical or biological target within the sample (processor 1019 in Fig. 10 receives electrical property measurements and compares them with predetermined data to automatically determine whether the analyte is present [0074]).
Modified Gu and Astley are both considered analogous to the claimed invention because they are in the same field of instruments that detect a target substance using a potentiostat. 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 device in modified Gu by providing a memory configured to store predetermined threshold data and adding a processor configured to compare the measured potential difference and the stored threshold data to confirm the presence or absence of the chemical or biological target within the sample, as taught by Astley, because it would enable automatic detection of the analyte ([0074] in Astley). Furthermore, the claimed device only differs from the prior art by the actual lack of combination of the device in modified Gu with the memory and processor in Astley. One of ordinary skill in the art could combine the elements by known methods, with each element merely performing the same function as it does separately, to yield predictable results (MPEP 2143(I)(A)).
Allowable Subject Matter
Claims 10-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art to the present invention of claim 10 is Gu in view of Gao (see rejection of claim 5 above), and further in view of Easley et al. (US 20180259483 A1). Modified Gu, as applied to claim 5, does not teach the limitation of claim 10: “wherein the first electrode module is provided with a component configured to generate or change the concentration of the chemical or biological target.” While the limitation “configured to generate or change the concentration of the chemical or biological target” is a functional recitation (see MPEP 2114(II)), modified Gu does not teach a component included in the first electrode module that is configured to perform the functional limitation.
Easley teaches a device for detecting the presence or absence of a chemical or biological target within a sample (system 80 in Fig. 8 including the differential potentiostat 20 in Fig. 1B detects a target molecule [0042, 0058, 0060]), the device comprising:
an electrochemical cell comprising a first electrode module (second working
electrode W2 in Fig. 8 [0058]), a second electrode (first working electrode W1 in Fig. 8 [0058]) and an electrolyte container (sample cell 82 in Fig. 8 [0058]) configured to immerse both the first electrode module and the second electrode in an electrolyte solution (working electrodes W1 and W2 are immersed in sample 84 in Fig. 8 [0058]), wherein the second electrode is functionalized with an antibody (first working electrode W1 is coated with first recognition element 86 in Fig. 8, which is an antibody [0058]);
wherein the first electrode module is provided with a component (second working electrode W2 is coated with second recognition element 88 in Fig. 8 [0058]) configured to generate or change the concentration of the chemical or biological target (the recognition element 88 of the second working electrode W2 in Fig. 8 is configured to interact with the target molecule [claim 3]. Thus, the recognition element changes the concentration of the target by interacting with the target and pulling the target out of the bulk solution).
However, the component configured to generate or change the concentration of the chemical or biological target in Easley is attached to a secondary working electrode that is not included in modified Gu, and adding a secondary working electrode to the first electrode module in modified Gu would teach away from both limitations a) and b) in claim 5 of the instant application, as limitation a) requires that the first electrode module comprise a single first electrode, and limitation b) requires that two electrodes in the first electrode module comprise reference electrodes. Additionally, there does not appear to be any teaching, suggestion, or motivation for why one skilled in the art would add a component configured to generate or change the concentration of the chemical or biological target to the first electrode module in modified Gu, which is a reference electrode [0091-0092 in Gu]. Changing the local concentration of the chemical or biological target near the reference electrode would not improve its purpose of providing a known, stable reference potential to measure the working electrode against.
Claim 10 is therefore considered to be patentably distinguished from the prior art of record. The prior art of record, whether taken alone or in combination, does not disclose nor render obvious the cumulative limitations of claim 10. Claim 11 is dependent from or otherwise includes the limitations of claim 10 and is allowable for the same reasons above.
Response to Arguments
Applicant's arguments, see Remarks Pgs. 5-9, filed 5/28/2025, with respect to the 35 U.S.C. § 103 rejections have been fully considered, and all rejections from the previous office action are withdrawn in response to the amendments to the claims.
Applicant’s Argument #1:
Applicant argues on pgs. 6-7 that one of ordinary skill in the art would not modify Wei with the teachings of Bentley to arrive at the invention of amended claim 5 because Wei operates at a microampere level and the quasi-reference counter electrode of Bentley operates at femto- to nanoampere levels.
Examiner’s Response #1:
Applicant's arguments have been fully considered, but are not persuasive. Bentley teaches that the smaller ampere magnitude is a result of the nanoscale of the system [pg. 7700, col. 2, para. 1]. Thus, substituting the auxiliary and reference electrodes in Wei with the QRCE in Bentley would not render the system of Wei unsatisfactory. Rather, the substitution would be necessary to minimize the size of the electrochemical system to the nanoscale, which is the original motivation for the modification of Wei. Nevertheless, the arguments are moot in view of the new grounds of rejection necessitated by the applicant’s amendment of claim 5 that adds limitations a) and b).
Applicant’s Argument #2:
Applicant argues on pgs. 7-8 that Easley in view of Kuphaldt does not teach the limitations of amended claim 5.
Examiner’s Response #2:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection.
Applicant’s Argument #3:
Applicant argues on pg. 8 that because claims 6-11, 13-15, and 18-19 depend on or otherwise recite the limitations of independent claim 5, if independent claim 5 is allowable, dependent claims 6-11, 13-15, and 18-19 are likewise allowable.
Examiner’s Response #3:
Based on the above responses #1-#2, applicant’s arguments regarding the amended claim 5 are not persuasive or moot in view of the new grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLEE Y TSENG whose telephone number is (703)756-5542. The examiner can normally be reached Mon - Fri 9-6 PT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached at (571)272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.T./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795
Prosecution Insights