DETAILED ACTION
Response to Amendment
This is a final office action in response to a communication filed on April 14,, 2026. Claims 1-4, 6-20, 22-23, and 26-27 are pending in the application.
Status of Objections and Rejections
The rejection of claim 5 is obviated by Applicant’s cancellation.
All rejections from the previous office action are withdrawn in view of Applicant’s amendment. New grounds of rejection are necessitated by the amendments.
Claim Objections
Claim(s) 27 is/are objected to because of the following informalities:
Claim 27, lines 1-2: “nanotubes of have an average length greater between 3 µm to 4 µm” should be “nanotubes have an average length between 3 µm to 4 µm”
Appropriate correction is required.
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.
Claim(s) 1-3 and 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharyya (D. Bhattacharyya, Titania Nanotube Array Sensor for Electrochemical Detection of Four Predominate Tuberculosis Volatile Biomarker, Journal of The Electrochemical Society, 2016, 163(6), pp. B206-B214) in view of Bhattacharyya Patent’925 (U.S. 2014/0193925), and further in view of Lee (US 2020/0150074), alternatively further in view of Jayamohan (H. Jayamohan, Platinum functionalized titania nanotube array sensor for detection of Trichloroethylene in water, IEEE Xplore, 2013 (November), pp. 1-4) or Jankulovska (M. Jankulovska, Hierarchically organized titanium dioxide nanostructured electrodes: Quantum-sized nanowires grown on nanotubes, Electrochemistry Communications, 2010 (12), pp. 1356-1359).
Regarding claims 1-3, Bhattacharyya teaches a sensor device (p. B207, col. 2, para. 2: a custom built sensing chamber using a two-electrode potentiostat system, including a working electrode with the Co-TNA surface and a counter electrode) comprising:
a working electrode (p. B207, col. 2, para. 2) comprising a plurality of functionalized nanotubes (p. B207, col. 1, para. 2: cobalt functionalization of titanium dioxide nanotubes array (TNA)), wherein the functionalized nanotubes comprise anodized metal oxide-based nanotubes (p. B206, col. 2, last para.: titania nanotubes were synthesized by electrochemical anodization of titanium foils) functionalized with a metal ion species (p. B207, col. 1, para. 2: cobalt functionalized titanium dioxide nanotubes (Co-TNA); p. B208, col. 1, last para.: Co2+ oxidation state), wherein the anodized metal oxide-based nanotubes comprises titanium oxide (p. B206, col. 2, last para.: titania nanotubes were synthesized by electrochemical anodization of titanium foils; here, the titania is titanium oxide obtained by anodizing titanium foils);
a counter electrode (p. B207, col. 2, para. 2); and
a potentiostat (p. B207, col. 2, para. 2).
Bhattacharyya does not teach a substrate-based comprising a fiber-based material (claim 1) or wherein the fiber-based material is a cellulosic fiber-based material (claim 2) or wherein the fiber-based material is paper obtained from wood, hemp, cotton, etc. (claim 3).
However, Bhattacharyya Patent’925 teaches a biosensor based on conductive polymers, which are arranged on high surface area substrate, such as a high surface area electro-spun polymer fiber mat (¶6). The fiber-based material provides a substantially higher specific surface area than a flat (i.e., smooth, non-textured) substrate (¶47), and thus increases the sensitivity of the sensors (¶76). The fiber-based material , e.g., various types of papers, textile fibers (¶47), from cotton, hemp, wood (¶51). Further, the substrate can be provided in the form of a test strip configured to be used with a testing device (¶36). Because the test strips can be modular, test strips configured for different purposes can be used with the same testing device (¶37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bhattacharyya by incorporating a fiber mat, e.g., in a test strip form, as taught by Bhattacharyya Patent’925 because the fiber-based material, e.g., paper, textile fibers, etc., would provide a high specific surface area for increased sensor sensitivity (¶76) and the form of test strip would have diverse usages as a module (¶37).
The designation “wherein the metal ion species and/or an electroactive polymer component has been electrodeposited on to the anodized metal oxide-based nanotubes” is product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113(I).
Bhattacharyya does not teach a reference electrode.
However, Lee teaches a test strip including a working electrode 110, a counter electrode 120, and a reference electrode 130 (Fig. 1; ¶21). The reference electrode 130 is used to control the potential of the working electrode 110, which is kept at a certain potential difference from the working electrode 110 to maintain a stable voltage, e.g., Ag/AgCl electrode (¶24).
It would have been obvious to one of ordinary skill in the art to modify Bhattacharyya by incorporating a reference electrode as taught by Lee because a reference electrode is known in the art to maintain a stable voltage for electrochemical measurement. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Bhattacharyya does not disclose the anodized metal oxide-based nanotubes have an average length greater than 3 µm.
However, Bhattacharyya teaches each nanotube has a length ~1.5 µm (p. B208, col. 1, last para.), which is close to the recited range. The pertinent art, Jayamohan, teaches a titanium nanotube array sensor (title), with tunable size (nanotube diameter and length) (p. 1, col. 2, para. 2), e.g., approximately 1-1.4 µm in length (p. 2, col. 1, last para.), which renders the nanotube length a result-effective variable. Further, the pertinent art, Jankulovska, teaches titanium dioxide nanostructured electrode (title) with applications, e.g., gas sensing, electrochemical devices (p. 1356, col. 1, para. 1), including a nanotube layer grown by anodization of a piece of Ti foil (p. 1356, col. 2, para. 2). The length of the nanotubes was varied between 4 and 10 µm by changing the anodization time ([Abstract[), e.g., tubes having around 120 nm in external diameter, 90 nm internal diameter and 4 µm in length (Fig. 1a and b; p. 1357, col. 1, para. 1), which lies in the recited range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bhattacharyya, Bhattacharyya Patent’925, and Lee by adjusting the length of the metal-based nanotubes within the claimed range as taught or suggested by Bhattacharyya (alternatively by Jayamohan or Jankulovska) because in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I). Further, the average length of the metal oxide-based nanotubes can be optimized through routine experimentation without surprising or unexpected results.. MPEP 2144.05 (II)(B).
Regarding claim 6, Bhattacharyya teaches wherein the anodized metal oxide-based nanotubes comprises TiO2 (p. B207, col. 1, para. 2: titanium dioxide nanotubes array (TNA)).
Regarding claim 7, Bhattacharyya teaches wherein the metal ion species is a cobalt ion (p. B207, col. 1, para. 2: cobalt functionalization of titanium dioxide nanotubes array (TNA); p. B208, col. 1, last para.: Co2+ oxidation state).
Regarding claim 8, Bhattacharyya teaches wherein the metal ion species is Co2+ (p. B208, col. 1, last para.: Co2+ oxidation state).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharyya in view of Bhattacharyya Patent’925 and Lee (or alternatively further in view of Jayamohan or Jankulovska), and further in view of Liu (CN 105486873), supported by Lange (U. Lange, Integrated electrochemical transistor as a fast recoverable gas sensor, Analytica Chimica Acta, 2011(687), pp. 7-11; cited by Bhattacharyya Patent’925) as an evidence.
Regarding claim 9, Bhattacharyya, Bhattacharyya Patent’925, and Lee (or alternatively further in view of Jayamohan or Jankulovska) disclose all limitations of claim 1, but fail to teach an electroactive polymer component (from claim 1) that is a polyaniline (claim 9). Bhattacharyya Patent’925 cites Lange for using chemosensitive polymer for electrochemical sensors, e.g., polythiophene or polyaniline (Bhattacharyya Patent’925, ¶33; Lange, [Abstract]).
However, Liu teaches an electrochemical sensor using a TiO2 nanotube (TNT) composite material, i.e., the GNPs-PANI-TNT composite material ([Abstract]). The method is to prepare TiO2 nanotubes, followed by synthesis of polyaniline-TiO2 nanotube composite, followed by incorporating gold nanoparticles (p. 4). The sensor has high sensitivity, large linear range and low detection limit ([Abstract]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bhattacharyya, Bhattacharyya Patent’925 and Lee (or alternatively further in view of Jayamohan or Jankulovska) by incorporating polyaniline, a conducting polymer, into the working electrode as taught by Liu because the sensor based on GNPs-PANI-TNT composite material would have high sensitivity, large linear range and low detection limit ([Abstract]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharyya in view of Bhattacharyya Patent’925, Lee, and Liu (or alternatively further in view of Jayamohan or Jankulovska), and further in view of Belbruno (US 2014/0227795).
Regarding claim 10, Bhattacharyya, Bhattacharyya Patent’925, Lee, and Liu (or alternatively further in view of Jayamohan or Jankulovska) disclose all limitations of claim 9, but fails to teach wherein the polyaniline polymer has an average Mw ranging from 1,000 to 100,000.
However, Belbruno teaches conductive elements for molecularly imprinted polymer (MIP) sensors, using a polyaniline/polyethyleneimine (PANi/PEI) composite films (¶7). The molecular weight of polyaniline is 15,000 (¶99).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bhattacharyya, Bhattacharyya Patent’925, Lee, and Liu (or alternatively further in view of Jayamohan or Jankulovska) by adjusting the molecular weight of the conducting polymer, polyaniline within the claimed range because it represents a suitable molecular weight of conductive polymer for electrode of a biosensor. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharyya in view of Bhattacharyya Patent’925 and Lee (or alternatively further in view of Jayamohan or Jankulovska), and further in view of Chiba (US 2012/0118761).
Regarding claim 11, Bhattacharyya, Bhattacharyya Patent’925, and Lee (or alternatively further in view of Jayamohan or Jankulovska) discloses all limitations of claim 1, including an Ag/AgCl reference electrode (Lee, ¶24) but fail to disclose the counter electrode is a titanium electrode.
However, Chiba teaches a CNT sensor including a working electrode, a counter electrode, and a reference electrode ([Abstract]). The material of the counter electrode is titanium (¶42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bhattacharyya, Bhattacharyya Patent’925, and Lee (or alternatively further in view of Jayamohan or Jankulovska) by substituting the counter electrode with the titanium one as taught by Chiba. The suggestion for doing so would have been that titanium is a suitable material for the counter electrode and 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.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharyya in view of Bhattacharyya Patent’925 and Lee (or alternatively further in view of Jayamohan or Jankulovska), and further in view of Liu, and further in view of Chiba.
Regarding claim 12, Bhattacharyya, Bhattacharyya Patent’925, and Lee (or alternatively further in view of Jayamohan or Jankulovska) discloses all limitations of claim 1, including wherein the substrate comprises a cellulosic fiber material (Bhattacharyya Patent’925, ¶51); wherein the functionalized nanotubes comprises TiO2-based nanotubes (Bhattacharyya, p. B207, col. 1, para. 2: cobalt functionalization of titanium dioxide nanotubes array (TNA)); wherein the reference electrode is Ag/AgCl (Lee, ¶24).
Bhattacharyya, Bhattacharyya Patent’925 and Lee (or alternatively further in view of Jayamohan or Jankulovska) do not disclose TiO2-based nanotubes functionalized an electroactive polyaniline polymer.
However, Liu teaches an electrochemical sensor using a TiO2 nanotube (TNT) composite material, i.e., the GNPs-PANI-TNT composite material ([Abstract]). The method is to prepare TiO2 nanotubes, followed by synthesis of polyaniline-TiO2 nanotube composite, followed by incorporating gold nanoparticles (p. 4). The sensor has high sensitivity, large linear range and low detection limit ([Abstract]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bhattacharyya, Bhattacharyya Patent’925 and Lee (or alternatively further in view of Jayamohan or Jankulovska) by substituting the functionalized nanotubes with TiO2-based nanotubes functionalized polyaniline as taught by Liu because the sensor based on GNPs-PANI-TNT composite material would have high sensitivity, large linear range and low detection limit ([Abstract]).
Bhattacharyya, Bhattacharyya Patent’925, and Lee (or alternatively further in view of Jayamohan or Jankulovska) do not disclose wherein the counter electrode is a titanium electrode.
However, Chiba teaches a CNT sensor including a working electrode, a counter electrode, and a reference electrode ([Abstract]). The material of the counter electrode is titanium (¶42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bhattacharyya, Bhattacharyya Patent’925, and Lee (or alternatively further in view of Jayamohan or Jankulovska) by substituting the counter electrode with the titanium one as taught by Chiba. The suggestion for doing so would have been that titanium is a suitable material for the counter electrode and 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.
Regarding claim 13, Bhattacharyya teaches wherein the functionalized nanotubes are further functionalized with cobalt ions (p. B207, col. 1, para. 2: cobalt functionalization of titanium dioxide nanotubes array (TNA); p. B208, col. 1, last para.: Co2+ oxidation state).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharyya in view of Bhattacharyya Patent’925 and Lee, and further in view of Jankulovska.
Regarding claim 27, Bhattacharyya, Bhattacharyya Patent’925, and Lee disclose all limitations of claim 1 except for the limitation regarding the average length of the nanotubes, more specifically, wherein the anodized metal oxide-based nanotubes of have an average length greater between 3 µm to 4 µm.
However, Jankulovska, teaches titanium dioxide nanostructured electrode (title) with applications, e.g., gas sensing, electrochemical devices (p. 1356, col. 1, para. 1), including a nanotube layer grown by anodization of a piece of Ti foil (p. 1356, col. 2, para. 2). The length of the nanotubes was varied between 4 and 10 µm by changing the anodization time ([Abstract]), e.g., tubes having around 120 nm in external diameter, 90 internal diameter and 4 µm in length (Fig. 1a and b; p. 1357, col. 1, para. 1), which lies in the recited range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bhattacharyya, Bhattacharyya Patent’925, and Lee by adjusting the length of the metal-based nanotubes within the claimed range as suggested by Jankulovska because in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I).
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive in light of new grounds for rejection.
Applicant argues Bhattacharyya teaches the nanotube length is ~ 1.5 µm that is not the same or equivalent to the nanotubes of the present patent application with an average length greater than 3 µm (Response, bridging para. of pp. 2-3). Applicant further argues that use of nanotubes having an average length greater than 3 m would render the titania nanotublar arrays of Bhattacharyya unsatisfactory for their intended use (p. 3, para. 3) and Bhattacharyya teaches away the nanotube length greater than 3 µm (p. 4, para. 2) based on the Debye length. These arguments are unpersuasive because Bhattacharyya teaches a similar nanotube length to the recited one. Here, Examiner notes that the Debye length is comparable to the nanotube thickness or distance between nanotubes, not the nanotube length.
Further, even if the nanotube length of ~1.5 µm is not close enough to the recited range, Examiner cited new prior art, Jayamohan, that teaches the nanotube length is tunable (p. 1, col. 2, para. 2) and renders it a result-effective variable for optimization and Jankulovska that teaches a TiO2 nanostructure electrodes having a 4 µm tube length (p. 1357, col. 1, para. 1), which anticipate or render the claimed ranges of claims 1 and 27 obvious.
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 extension fee 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.
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/C. SUN/Primary Examiner, Art Unit 1795
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