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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 6, “the biosensor electrodes” should read “the electrodes”.
In lines 12-13, Examiner suggests amending “a plurality of first voltage cycles and a plurality of second voltage cycles” to read “the first voltage cycle and the second voltage cycle”.
Appropriate correction is required.
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.
Claims 1-6 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.
Claim 1 recites the limitation “each of the first voltage cycle and the second voltage cycle comprise a minimum voltage that is less than 0 V and a maximum voltage that is greater than 0 V” in lines 9-10 of the claim. It is unclear whether the first voltage cycle and the second voltage cycle have the same minimum voltage and the same maximum voltage, or if they have different minimum voltages and different maximum voltages. For the purpose of examination, Examiner interprets them to each have a different minimum voltage and a different maximum voltage. Claims 2-6 are rejected as dependent thereon.
Claim 2 recites the limitation “the maximum voltage is between 0.8 V and 1.0 V, and the minimum voltage is between -0.4 V and -0.2 V” in lines 1-3 of the claim. It is unclear whether this is for just the first voltage cycle or for both the first voltage cycle and the second voltage cycle. For the purpose of examination, Examiner interprets this limitation to be for the first voltage cycle. If that is the correct interpretation, then Examiner suggests amending the limitation to recite “the maximum voltage of the first voltage cycle is between 0.8 V and 1.0 V, and the minimum voltage of the first voltage cycle is between -0.4 V and -0.2 V”.
Claim 3 recites the limitation “the minimum voltage is between -2.1 V and -1.9 V, and the maximum voltage is between 1.4 V and 1.6 V” in lines 2-3 of the claim. It is unclear whether this is for just the second voltage cycle or for both the first voltage cycle and the second voltage cycle. For the purpose of examination, Examiner interprets this limitation to be for the second voltage cycle. If that is the correct interpretation, then Examiner suggests amending the limitation to recite “the minimum voltage of the second voltage cycle is between -2.1 V and -1.9 V, and the maximum voltage of the second voltage cycle is between 1.4 V and 1.6 V”.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over McCormack et al. (US 2008/0035481 A1).
Regarding claim 1, McCormack teaches a method of manufacturing a biosensor (a method for preparing an electrode for use in an electrochemical sensor, para. [0014], [0016]), comprising:
printing electrodes on a substrate using metallic ink (screen-printing electrodes 2 and 3 on a substrate 1 using silver, Figs. 11-12, para. [0109]-[0110]);
printing a carbon surface using carbon-containing ink, the carbon surface being in electrical communication with the electrodes (screen-printing a working electrode 4 comprising carbon materials on the substrate 1 such that all three electrodes 2, 3, and 4 are in electrical communication via the three terminals 5, Figs. 11-12, para. [0072], [0097]-[0098], [0107], [0109]-[0110], [0128]);
immersing the substrate in an acid bath having a pH of 3.0 or less and applying a first voltage cycle to the biosensor electrodes (the cyclic voltammetric response of the carbon-containing electrode was measured over the pH range 1-12 which includes pH of 1.0 with a voltage cycle of from -0.8 V to 0.4 V or from -1.0 V to 0.8 V, Figs. 2 & 16a, para. [0132]-[0133], [0243]); and
immersing the substrate in a basic bath and applying a second voltage cycle (the cyclic voltammetric response of the carbon-containing electrode was measured over the pH range 1-12 which includes pH of 12 with a voltage cycle of from -0.8 V to 0.4 V or from -1.0 V to 0.8 V, Figs. 2 & 16a, para. [0132]-[0133], [0243]).
McCormack teaches pH of 12, and fails to explicitly teach having a pH of 13.0 or more.
However, McCormack teaches wherein the pH is a result-effective variable. Specifically, McCormack teaches that the pH has an effect on the peak potential (Fig. 3, para. [0134], [0242]-[0243]). Since these particular parameters are recognized as result-effective variables, i.e. a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See In re Boesch, 617 F. 2d 272, 205 U.S.P.Q. 215 (C.C.P.A. 1980).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the basic pH of McCormack to be 13.0 or more through routine experimentation because doing so would yield the predictable desired peak potential.
Modified McCormack teaches wherein each of the first voltage cycle and the second voltage cycle comprise a minimum voltage that is less than 0 V and a maximum voltage that is greater than 0 V (voltage cycles of from -0.8 V to 0.4 V or from -1.0 V to 0.8 V, Figs. 2 & 16a, para. [0132]-[0133], [0243]).
In method claims, it is the overall method steps that are given patentable weight and not the intended result thereof because the intended result does not materially alter the overall method. In method claims, the intended result is not given patentable weight when it simply expresses the intended result of a process step positively recited (MPEP § 2111.04). The limitation “the minimum voltage and the maximum voltage being selected to avoid damaging the electrodes and the carbon surface across a plurality of first voltage cycles and a plurality of second voltage cycles” is an intended result of a positively recited step, and does not further limit the method or steps. The court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). MPEP 2111.04(I). In this case, Modified McCormack teaches the claimed structure, materials, and steps of claim 1 including a minimum voltage that is less than 0 V and a maximum voltage that is greater than 0 V (see rejection supra), so Modified McCormack is expected to predictably avoid damaging the electrodes and the carbon surface across a plurality of first voltage cycles and a plurality of second voltage cycles as claimed.
Regarding claims 4-5, McCormack teaches embodiments wherein the cyclic voltammetric response can be observed over many repeat cycles to ensure stability of the electrodes (para. [0238], [0261]), but fails to explicitly teach wherein the first voltage cycle is applied 50 times or more, of instant claim 4, or wherein the second voltage cycle is applied 50 times or more, of instant claim 5.
However, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to duplicate and repeat each voltammetric cycle to be applied 50 times or more in order to yield the predictable result of ensuring stability of the electrodes. Additionally, generally, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over McCormack as applied to claim 1 above, and further in view of Zakashansky et al. (US 2023/0050906 A1).
Regarding claim 6, Modified McCormack teaches the electrodes 2, 3, and 4 on the substrate 1 (McCormack, Figs. 11-12, para. [0109]-[0110]). Modified McCormack fails to teach wherein the electrodes and the substrate are cured by heating to a temperature of between 100-150°C for 10 minutes or more.
Zakashansky teaches the fabrication and use of stretchable wrinkled electrodes for electrochemical detection (Zakashansky, para. [0002]). Zakashansky teaches that the electrode 200 comprises a shrunken metallic film 140 and an elastomer 150 (Zakashansky, Fig. 10, para. [0078]). Zakashansky teaches that the electrode 200 is placed in an oven ranging in temperature from about 125°C to 145°C for about 10 to 15 minutes to shrink the electrode 200 (Zakashansky, Fig. 10, para. [0073]). Zakashansky teaches that the shrunken electrodes achieve enhanced signals and current densities (Zakashansky, para. [0111]-[0112]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Modified McCormack to include heating the electrodes and the substrate in an oven ranging in temperature from about 125°C to 145°C for about 10 to 15 minutes as taught by Zakashansky in order to yield the predictable result of forming an electrode with enhanced signals and current densities. MPEP § 2143(I)(C), 2143(I)(D).
Allowable Subject Matter
Claims 2-3 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 prior art does not disclose nor render obvious all of the cumulative limitations of dependent claims 2-3, with particular attention to the limitations:
“the maximum voltage is between 0.8 V and 1.0 V, and the minimum voltage is between -0.4 V and -0.2 V” of dependent claim 2 in combination with the limitations of independent claim 1, and
“the minimum voltage is between -2.1 V and -1.9 V, and the maximum voltage is between 1.4 V and 1.6 V” of dependent claim 3 in combination with the limitations of independent claim 1.
The closest prior art of record is considered to be McCormack et al. (US 2008/0035481 A1). McCormack teaches that the cyclic voltammetric response of the carbon-containing electrode was measured over the pH range 1-12 with a voltage cycle of from -0.8 V to 0.4 V or from -1.0 V to 0.8 V (Figs. 2 & 16a, para. [0132]-[0133], [0243]). McCormack fails to teach “the maximum voltage is between 0.8 V and 1.0 V, and the minimum voltage is between -0.4 V and -0.2 V” of dependent claim 2 in combination with the limitations of independent claim 1, and “the minimum voltage is between -2.1 V and -1.9 V, and the maximum voltage is between 1.4 V and 1.6 V” of dependent claim 3 in combination with the limitations of independent claim 1.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VIVIAN A TRAN whose telephone number is (571)272-3232. The examiner can normally be reached Mon - Fri 9am-5pm.
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, James Lin can be reached at (571) 272-8902. 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.
/V.T./ Examiner, Art Unit 1794
/SHIZHI QIAN/ Primary Examiner, Art Unit 1795
Prosecution Insights