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 .
Election/Restrictions
Applicant's election with traverse of Group I, in the reply filed on September 19 is acknowledged. Claims withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II-IV, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on September 19, 2025.
The traversal is on the ground(s) that the. This is not found persuasive because this restriction requirement is for unity of invention that e.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
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.
Claim(s) 12-13 is/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 pre-AIA the applicant regards as the invention.
Claim 12 recites “a plurality of functionalized nanotubes” in line 3. It is unclear whether they are the same nanotubes as recited in claim 1. It is suggested to delete “the working electrode comprises a plurality of functionalized nanotubes, wherein”.
Dependent claim 13 is rejected due to its dependency on rejected base claim 12.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3 and 5-8 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), 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 claims 1-3, Bhattacharyya teaches a platform (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 metal oxide-based nanotubes (titanium dioxide nanotubes) functionalized with a metal ion species (cobalt functionalization; p. B208, col. 1, last para.: Co2+ oxidation state); and
a counter electrode (p. B207, col. 2, para. 2).
Bhattacharyya does not teach the platform is a substrate-based or the substrate 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 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).
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 well-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).
Regarding claim 5, Bhattacharyya, Bhattacharyya Patent’925, and Lee disclose all limitations of claim 1. Bhattacharyya further discloses wherein the metal oxide-based nanotubes of the plurality of functionalized nanotubes comprises a titanium oxide (p. B207, col. 1, para. 2: cobalt functionalization of titanium dioxide nanotubes array (TNA)).
Bhattacharyya, Bhattacharyya Patent’925, and Lee do not disclose the metal oxide-based nanotubes of the plurality of functionalized 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.).
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 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 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, and further in view of Liu (CN 105486873).
Regarding claim 9, Bhattacharyya, Bhattacharyya Patent’925, and Lee disclose all limitations of claim 1, but fail to teach an electroactive polymer component (from claim 1) that is a polyaniline (claim 9).
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 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, and further in view of Belbruno (US 2014/0227795).
Regarding claim 10, Bhattacharyya, Bhattacharyya Patent’925, Lee, and Liu 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 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, and further in view of Chiba (US 2012/0118761).
Regarding claim 11, Bhattacharyya, Bhattacharyya Patent’925, and Lee discloses all limitations of claim 1, including an Ag/AgCl reference electrode (Lee, ¶24) and amperometric detection of biomarkers using a two-electrode potentiostat system (Bhattacharyya, p. B207, col. 2, para. 2),
Bhattacharyya, Bhattacharyya Patent’925, and Lee do not 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 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, and further in view of Liu, and further in view of Chiba.
Regarding claim 12, Bhattacharyya, Bhattacharyya Patent’925, and Lee discloses all limitations of claim 1, including wherein the substrate comprises a cellulosic fiber material (Bhattacharyya Patent’925, ¶51); the functionalized nanotubes comprises TiO2-based nanotubes (Bhattacharyya, p. B207, col. 1, para. 2: cobalt functionalization of titanium dioxide nanotubes array (TNA)); the reference electrode is Ag/AgCl (Lee, ¶24).
Bhattacharyya, Bhattacharyya Patent’925 and Lee 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 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 do not 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 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).
Conclusion
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/C. SUN/Primary Examiner, Art Unit 1795