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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/20/2024 and 2/20/2025 has been considered by the examiner.
Election/Restrictions
Applicant's election of Group I, Claims 1-9, with traverse in the reply filed on 05/20/2026 is acknowledged.
The traversal is on the ground(s) that “all pending claims are directed to a single inventive concept. The three groups of claims are merely different embodiments of this single invention, not separate and distinct inventions. Furthermore, Qin does not disclose detection of pathogenic metabolites recited in the present claims, thus Qian does not provide the disclosure that supports the restriction requirement”. This is not found persuasive because there are three groups of claims of different embodiments as outlined in the previous restriction. Furthermore, “for detecting pathogenic metabolites” in claim 1 is an intended use limitation [see MPEP 2111.02]. 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, Qin teaches the electrochemical sensor which is substantially identical to the claimed electrochemical sensor, as outlined in the rejection of claim 1. Thus, the disclosed electrochemical sensor is capable of performing the intended use.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objection
Claims 2, 4, and 7-8 are objected to because of the following informalities:
Claim 2: please amend “wherein the first electrode is modified with cyclic oligosaccharide molecules” to --wherein the oligosaccharide molecules are cyclic oligosaccharide molecules--.
Claim 4: please amend “wherein the first electrode is modified with at least one of alpha-cyclodextrins, beta-cyclodextrins and gamma-cyclodextrins” to -- wherein the cyclodextrins or the modified cyclodextrins are at least one of alpha-cyclodextrins, beta-cyclodextrins and gamma-cyclodextrins--.
Claim 7: please amend “are a screen printed electrodes” to -- are [[a]] screen printed electrodes--.
Claim 8: please amend “an electrochemical sensor as claimed in claim 1” to – [[an]] the electrochemical sensor as claimed in claim 1--.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qin et al. (Electropolymerization of a conductive β-cyclodextrin polymer on reduced graphene oxide modified screen-printed electrode for simultaneous determination of ascorbic acid, dopamine and uric acid, Journal of electroanalytical chemistry, 2016, 782, 50-58).
Regarding claim 1, Qin teaches an electrochemical sensor (an electrochemical sensor as shown in Scheme 1), wherein the electrochemical sensor comprises a first electrode modified with oligosaccharide molecules (working electrode modified by [Symbol font/0x62]-CD as shown in Scheme 1 [section 3.1]).
The limitation “for detecting pathogenic metabolites” is an intended use limitation [see MPEP 2111.02]. 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, Qin teaches the electrochemical sensor comprising screen printed working, counter and reference electrodes wherein the working electrode is functionalized with [Symbol font/0x62]-CD, as shown in Scheme 1. The disclosed electrochemical sensor is substantially identical to the claimed electrochemical sensor, as outlined in the rejection of instant claim 1. Thus, the disclosed electrochemical sensor is capable of performing the intended use.
Regarding claim 2, Qin teaches the electrochemical sensor as claimed in claim 1, wherein the first electrode is modified with cyclic oligosaccharide molecules (the working electrode is modified with [Symbol font/0x62]-CD, as shown in Scheme 1).
Regarding claim 3, Qin teaches the electrochemical sensor as claimed in claim 2, wherein the cyclic oligosaccharide molecules comprise cyclodextrins or modified cyclodextrins or a combination of both (the working electrode is modified with [Symbol font/0x62]-CD, as shown in Scheme 1).
Regarding claim 4, Qin teaches the electrochemical sensor as claimed in claim 3, wherein the first electrode is modified with beta-cyclodextrins (the working electrode is modified with [Symbol font/0x62]-CD, as shown in Scheme 1).
Regarding claim 5, Qin teaches the electrochemical sensor as claimed in claim 1, and the limitation “wherein the first electrode is modified by electro-polymerization” is a product by process limitation. The determination of patentability is based upon the product or apparatus structure itself. Patentability does not depend on its method of production or formation. 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. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113).
Furthermore, Qin does teach wherein the first electrode is modified by electro-polymerization (see “electropolymerization” in Scheme 1).
Regarding claim 6, Qin teaches the electrochemical sensor as claimed in claim 1, comprising a second electrode (reference electrode in Scheme 1) and a third electrode (counter electrode in scheme 1), wherein the first electrode is a working electrode (the first electrode is working electrode as shown in scheme 1), the second electrode is a reference electrode (see scheme 1), and the third electrode is a counter electrode (see scheme 1).
Regarding claim 7, Qin teaches the electrochemical sensor as claimed in claim 6, and the limitation “wherein the first electrode, the second electrode and the third electrode are screen printed electrodes” is a product by process limitation. The determination of patentability is based upon the product or apparatus structure itself. Patentability does not depend on its method of production or formation. 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. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113).
Furthermore, Qin does teach wherein the first, second, and third electrodes are screen printed electrodes (see SPE in scheme 1, wherein the three electrodes are printed on a substrate).
Regarding claim 8, Qin teaches an electrochemical system comprising the electrochemical sensor as claimed in claim 1 (all electrochemical measurements were conducted using a CHI 660E electrochemical workstation [section 2.2], thus the system comprises the electrochemical sensor and the CHI 660E electrochemical workstation [sections 2.2 and 3.1]), and a potentiostat (CHI 660E electrochemical workstation [section 2.2]) coupled to the electrochemical sensor, wherein the potentiostat is configured to perform an electrochemical technique (see CV and DPV results in Figs. 5-6 and 8, respectively; thus the CHI 660E electrochemical workstation is configured to perform CV and DPV).
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 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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Qin, as applied to claim 8 above, and in view of Bellin et al. (Integrated circuit-based electrochemical sensor for spatially resolved detection of redox-active metabolites in biofilms, Nature Communications, 2014, 3256).
Regarding claim 9, Qin teaches the electrochemical system as claimed in claim 8, and is silent to wherein the electrochemical sensor and the potentiostat are integrated in a portable device or a wearable device.
Bellin teaches integrated circuit (IC)-based electrochemical sensor for detection of redox-active metabolites (title), wherein the IC sensing platform features an integrated control amplifier at the core of a potentiostat capable of establishing on-chip electrochemical cells (see Integrated circuit sensing platform and Figs. 2a and 2b). Thus, Bellin teaches wherein the electrochemical sensor and the potentiostat are integrated in a portable device (integrated circuit sensing platform).
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 in Qin by integrating the potentiostat and the three SPEs into an integrated circuit sensing platform, as taught by Bellin, since it would enable many measurement channels and electrodes to be fabricated within a very small area, and enable localized multiplexed and high-speed recordings no possible with macroscale electrochemical instruments (the 3rd paragraph in Col. 2 on page 7 in Bellin). Furthermore, the use of a one-piece, integrated construction instead of the structure disclosed or taught in the prior art would have been within the ambit of a person of ordinary skill in the art. See In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (see MPEP § 2144.04).
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Alarcon-Angeles et al. (Enzyme entrapment by [Symbol font/0x62]-cyclodextrin electropolymization onto a carbon nanotubes-modified screen printed electrode, biosensors and bioelectronics, 2010, 26, 1768, 1773) teaches SPE Working, counter and reference electrodes wherein the working electrode is functionalized by [Symbol font/0x62]-cyclodextrin. Taleat et al. (Screen-printed electrodes for biosensing: a review (2008-2013), Microchim Acta, 2014, 181: 865-891) teaches SPEs for biosensing. Ayyub et al. (US20160168613A1) teaches a biosensor comprising WE, CE and RE which can be formed by screen-printed, and the biosensor is coupled to a potentiostat.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V. Van can be reached on (571) 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIZHI QIAN/Examiner, Art Unit 1795
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