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 08/27/2024 and 02/27/2025 has been considered by the examiner.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
Claim 1, lines 2-3: please amend “the working electrode, the counter electrode, and the reference electrode” to – [[the]]a working electrode, [[the]]a counter electrode, and [[the]]a reference electrode--.
Claim 3, lines 3-4: please amend “the reference electrode, the counter electrode, and the working electrode” to – [[the]]a reference electrode, [[the]]a counter electrode, and [[the]]a working electrode--.
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 2 and 4 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.
Regarding claim 2, claim 2 recites “the step of establishing the current potential profile….based on a current density”. Thus, claim 2 requires the voltammogram to be plotted as a current density vs potential profile. However, claim 1, on which claim 2 depends requires a current vs potential profile to be plotted because it recites “establishing a current-potential or I-V profile” in line d. The scope of the claim is unclear because it is unclear if the claim requires 1) a current-potential profile or 2) a current density-potential profile, or 3) both. Therefore, the scope of claim 2 is indefinite.
Regarding claim 4, claim 4 recites “the step of establishing the current potential profile….based on a current density”. Thus, claim 4 requires the voltammogram to be plotted as a current density vs potential profile. However, claim 3, on which claim 4 depends requires a current vs potential profile to be plotted because it recites “establishing a current-potential or I-V profile” in line d. The scope of the claim is unclear because it is unclear if the claim requires 1) a current-potential profile or 2) a current density-potential profile, or 3) both. Therefore, the scope of claim 4 is indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 are rejected under 35 USC § 101.
Regarding independent claims 1 and 3, Claims 1 and 3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more. Claim 1 and 3 recite “establishing a current-potential or I-V profile of the biological material based on the measured current response”. This is an evaluation and therefore a mental step and abstract idea. Claim 3 further recites “comparing the I-V profile with a database having a list of known biological materials and its respective I-V profiles to identify the unknown biological material”. This is an evaluation and correlation and therefore a mental step and abstract idea. This judicial exception is not integrated into a practical application because once the abstract idea is completed nothing is done, much less a particular practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional structural elements of a working electrode, counter electrode and reference electrode as well as the additional method steps for characterizing and detecting the biological material are routine and conventional structures previously known to the pertinent industry such as the prior arts of Alzahra'a Alatraktchi et al., Mirica et al., and Wang et al.
Claims 1 and 3 are Ineligible due to the following analysis:
Step 1 (Statutory Category): Claims 1 and 3 are directed to a method, therefore, it is directed to a statutory category, i.e., a method/process (Step 1: YES).
Step 2A, Prong-1 (the claim(s) is evaluated to determine whether it is directed to a judicial-exception/abstract-idea): Claim 1 and 3 recite “establishing a current-potential or I-V profile of the biological material based on the measured current response”. This is an evaluation and therefore a mental step and abstract idea. Furthermore, a person can draw the profile/graph based on the measured current response and as it can be done with pen and paper is thus considered a mental process. The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’ (see MPEP 2106.04(a)(2)(III)). Claim 3 further recites “comparing the I-V profile with a database having a list of known biological materials and its respective I-V profiles to identify the unknown biological material” which is an evaluation and correlation and therefore a mental step and abstract idea. Comparing a profile with a database to identify the biological material is a mental step as it can be performed in the mind and thus an abstract idea. Furthermore, identifying is a mental process or math, and therefore an abstract idea. Therefore, claims 1 and 3 are directed to a judicial exception/abstract-idea (Step 2A, Prong-1: YES).
Step 2A, Prong-2 (the claim(s) is evaluated to determine whether the judicial-exception/abstract-idea is integrated into a Practical Application): the abstract idea in claims 1 and 3 related to establishing a current-potential profile based on the measured current response and comparing the I-V profile with a database to identify the unknown biological material, is not integrated into a practical application, and does not belong to a particular technological environment, industry or field since nothing is done after the mental step. For both claims, once the abstract idea is completed nothing is done, much less a particular practical application. Measuring a current response is data gathering which is an insignificant extra solution activity and not a particular practical application. Note that mere data gathering in a general way is not significantly more than the abstract idea. See MPEP 2106.05(g). The other elements of the claim are stated with a high degree of generality and would be considered generally linking the abstract idea to the field of endeavor (Step 2A, Prong-2: NO, because there is no integration of the abstract idea into a practical application).
Step 2B (the claim(s) is evaluated to determine whether recites additional elements that amount to an inventive concept, or also, the additional elements are significantly more than the recited the judicial-exception/abstract-idea): Claims 1 and 3 recite the additional element(s): depositing the sample onto the reference electrode, the counter electrode, and the working electrode; supplying a potential through the working electrode at a consecutive range under a specific scan rate; and measuring a current response as the supplied potential is swept linearly in time; which are just routine and conventional structures previously known to the pertinent industry (as evidenced by the prior arts of Alzahra'a Alatraktchi et al., Mirica et al., and Wang et al. in the current non-final office action), and thus, the structure is a well-known device and would not amount to significantly more. Note that measuring a current response as the supplied potential is swept linearly in time for data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). Therefore, the independent claims 1 and 3 do not include additional element(s) significantly more, and/or, does not amount to more than the judicial-exception/abstract-idea itself and the claim is not patent eligible (Step 2B: NO).
Regarding dependent claims 2 and 4, claims 2 and 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more. Claim 2 depends on the independent claim 1, and claim 4 depends on the independent claim 3, therefore, they have the abstract idea of independent claims 1 and 3, respectively, and they also fail to cure the deficiencies of claims 1 and 3 above. Furthermore, claims 2 and 4 further define and elaborate on the abstract idea by reciting the limitation(s) “wherein the step of establishing the current-potential profile includes obtaining a linear sweep voltammogram based on a current density, wherein the current density is obtained by normalizing the current response with a surface area of the working electrode” and is not eligible based on an analysis under step 2A prong one. Therefore, claims 2 and 4 do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
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 (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 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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Alzahra'a Alatraktchi et al. (US-20190137478-A1), hereinafter referred to as A-A.
Regarding claim 1, a method for characterizing a biological material (A-A teaches a method for detecting the presence of a sensing molecule in a biological sample [see e.g., Para. 0023, claim 10, Abstract]) is characterised by the steps of:
depositing a sample of the biological material onto the working electrode, the counter electrode, and the reference electrode (A-A teaches providing the biological sample to the electrodes, the electrodes comprising at least one reference electrode, at least one counter electrode, and two or more working electrodes [see e.g., Para. 0023, claim 10, Abstract, Figs. 2-4]);
supplying a potential through the working electrode at a consecutive range under a specific scan rate (A-A teaches supplying a potential [V] through the working electrode at a consecutive potential range of -1.0 V to 1.0 V at a scan rate of 0.05 V/s, and the working electrode potential is ramped linearly versus time [Para. 0116-0118, 0057-0058 and Figs. 6-7]);
measuring a current response as the supplied potential is swept linearly in time (A-A teaches measuring the current response [A] of the working electrode as the supplied potential is ramped linearly versus time in cyclic voltammetry [Para. 0116-0118, 0057-0058 and Figs. 6-7]); and
establishing a current-potential or I-V profile of the biological material based on the measured current response (A-A teaches establishing a current [A]-Potential [V] or I-V profile/cyclic voltammogram of the biological material [e.g., sputum sample] based on the measured current response [A] of the working electrode [Para. 0037-0038, 0116-0118, 0057-0058, 0134-0138, 0070-0073 and Figs. 6-7])
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alzahra'a Alatraktchi et al. (US-20190137478-A1), hereinafter referred to as A-A, in view of Wang et al. (Facile electrospinning preparation of phosphorus and nitrogen dual-doped cobalt-based carbon nanofibers as bifunctional electrocatalyst, 2016, Journal of Power Sources, Volume 311, Pages 68-80).
Regarding claim 2, the method as claimed in Claim 1, wherein the step of establishing the current-potential profile includes obtaining a linear sweep voltammogram (A-A teaches the voltammetry is selected from the group consisting of linear sweep voltammetry and cyclic voltammetry. A-A discloses other systematic variations of working electrode potential include linear sweep voltammetry [Para. 0090 and 0058; claim 14], corresponding to obtaining a linear sweep voltammogram. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the step of establishing the current-potential profile obtained with cyclic voltammetry of A-A with establishing the current-potential profile by linear sweep voltammetry by obtaining a linear sweep voltammogram, as taught by A-A, since A-A specifically discloses the voltammetry is selected from the group consisting of linear sweep voltammetry and cyclic voltammetry and other systematic variations of working electrode potential include linear sweep voltammetry [Para. 0090 and 0058; claim 14 of A-A]. Furthermore, the simple substitution of one known element for another (i.e., cyclic voltammetry with linear sweep voltammetry) is likely to be obvious when predictable results are achieved (i.e., recording the voltammetric response of the unknown biological material) [MPEP 2143[I][B]].)
Modified A-A does not explicitly disclose based on a current density, wherein the current density is obtained by normalizing the current response with a surface area of the working electrode.
Wang discloses electrochemical measurements, where the electrochemical properties of catalysts were tested by cyclic voltammetry, RDE and RRDE techniques [Abstract and Page 71, Col. 1, Para. 2]. Wang teaches the current density (j) was calculated by the ratio of current (i) and geometric area of working electrode (A) [corresponding to the surface area of the working electrode] [Page 71, Col. 2, Para. 3]. Wang further teaches the step of establishing the current-potential profile includes obtaining a LSV [linear sweep voltammogram] based on a current density, as seen in Fig. 3A and Fig. 4A [see Figs. 3-4]. The current density is obtained by normalizing the current response (i) with a geometric surface area of the working electrode (A) [Page 71, Col. 2, Para. 3 and Page 76, Col. 1, Para. 3].
Modified A-A and Wang are considered analogous art to the claimed invention because they are in the same field of electrochemical measurements [Abstract of A-A and Page 71, Col. 1, Para. 2 of Wang]. 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 A-A, which includes establishing a I-V profile by obtaining a linear sweep voltammogram, to be based on a current density, wherein the current density is obtained by normalizing the current response with a geometric surface area of the working electrode, as taught by Wang, since Wang teaches this suitable alternative method of plotting the electrochemical results in linear sweep voltammetry [Figs. 3-4 and Page 71, Col. 2, Para. 3 of Wang]. Furthermore, the use of a known technique (i.e., LSV plotted as current density vs potential, taught by Wang) to improve similar methods in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alzahra'a Alatraktchi et al. (US-20190137478-A1), hereinafter referred to as A-A, in view of Mirica et al. (US20210262970A1).
Regarding claim 3, a method for detecting an unknown biological material in a sample (A-A teaches a method for detecting the presence of an unknown biological material [e.g., AHL] in an unknown biological sample, where a positive response for AHL is denoted with the value 1 (as shown in FIG. 2), and a negative response for AHL is denoted with the value 0 [see e.g., Para. 0023 and 0078, claim 10, Abstract, Fig. 2]) is characterised by the steps of:
depositing the sample onto the reference electrode, the counter electrode, and the working electrode (A-A teaches providing the biological sample to the electrodes, the electrodes comprising at least one reference electrode, at least one counter electrode, and two or more working electrodes [see e.g., Para. 0023, claim 10, Abstract, Figs. 2-4]);
supplying a potential through the working electrode at a consecutive range under a specific scan rate (A-A teaches supplying a potential [V] through the working electrode at a consecutive potential range of -1.0 V to 1.0 V at a scan rate of 0.05 V/s, and the working electrode potential is ramped linearly versus time [Para. 0116-0118, 0057-0058 and Figs. 6-7]);
measuring a current response as the supplied potential is swept linearly in time (A-A teaches measuring the current response [A] of the working electrode as the supplied potential is ramped linearly versus time in cyclic voltammetry [Para. 0116-0118, 0057-0058 and Figs. 6-7]);
establishing a current-potential or I-V profile of the unknown biological material based on the measured current response (A-A teaches establishing a current [A]-Potential [V] or I-V profile/cyclic voltammogram of the biological material [e.g., AHL in a sputum sample] based on the measured current response [A] of the working electrode [Para. 0037-0038, 0116-0118, 0057-0058, 0134-0138, 0070-0073 and Figs. 6-7]); and
A-A does not explicitly disclose e) comparing the I-V profile with a database having a list of known biological materials and its respective I-V profiles to identify the unknown biological material.
Mirica discloses methods of detecting an analyte in a sample by associating the sample with an electrode and the presence or absence of the analyte in the sample is detected by correlating the redox properties of the electrode to the presence or absence of the analyte (Abstract and Fig. 1B). Mirica teaches obtaining a voltammetric response of the electrode obtained through cyclic voltammetry (CV) and the correlation occurs by comparing the redox properties [voltammetric response] of the electrode to a database that include redox properties [voltammetric response] of electrodes associated with known analytes, and this configuration is beneficial for detecting the presence or absence of analytes in a sample [Paras. 0109-0115; claims 1, 5, and 10]. The voltammetric response obtained through cyclic voltammetry corresponds to the I-V profile. The analytes include but are not limited to, neurochemicals, metabolites, drugs, vitamins, and combinations thereof [Para. 0121, claim 19].
A-A and Mirica are considered analogous art to the claimed invention because they are in the same field of electrochemical detection of analytes [Abstract of Mirica and Fig. 1 of A-A]. 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 A-A to provide comparing the I-V profile or voltammetric response with a database having a list of known biological materials/ analytes and the respective I-V profiles thereof to identify the unknown biological material as being present or absent in the sample, as taught by Mirica, since Mirica teaches this configuration would be beneficial for detecting the presence or absence of analytes in a sample [Paras. 0109-0115; claims 1, 5, and 10 of Mirica]. Furthermore, the use of a known technique (i.e., comparing the redox properties [voltammetric response] of the electrode to a database that include redox properties [voltammetric response] of electrodes associated with known analytes to identify the unknown biological material as being present or absent in the sample, taught by Mirica) to improve similar methods in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over A-A in view of Mirica as applied to claim 3 above, and further in view of Wang et al. (Facile electrospinning preparation of phosphorus and nitrogen dual-doped cobalt-based carbon nanofibers as bifunctional electrocatalyst, 2016, Journal of Power Sources, Volume 311, Pages 68-80).
Regarding claim 4, the method as claimed in Claim 3, wherein the step of establishing the current-potential profile includes obtaining a linear sweep voltammogram (A-A teaches the voltammetry is selected from the group consisting of linear sweep voltammetry and cyclic voltammetry. A-A discloses other systematic variations of working electrode potential include linear sweep voltammetry [Para. 0090 and 0058; claim 14], corresponding to obtaining a linear sweep voltammogram. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the step of establishing the current-potential profile obtained with cyclic voltammetry of Modified A-A with establishing the current-potential profile by linear sweep voltammetry by obtaining a linear sweep voltammogram, as taught by A-A, since A-A specifically discloses the voltammetry is selected from the group consisting of linear sweep voltammetry and cyclic voltammetry and other systematic variations of working electrode potential include linear sweep voltammetry [Para. 0090 and 0058; claim 14 of A-A]. Furthermore, the simple substitution of one known element for another (i.e., cyclic voltammetry with linear sweep voltammetry) is likely to be obvious when predictable results are achieved (i.e., recording the voltammetric response of the unknown biological material) [MPEP 2143[I][B]].)
Modified A-A does not explicitly disclose based on a current density, wherein the current density is obtained by normalizing the current response with a surface area of the working electrode.
Wang discloses electrochemical measurements, where the electrochemical properties of catalysts were tested by cyclic voltammetry, RDE and RRDE techniques [Abstract and Page 71, Col. 1, Para. 2]. Wang teaches the current density (j) was calculated by the ratio of current (i) and geometric area of working electrode (A) [corresponding to the surface area of the working electrode] [Page 71, Col. 2, Para. 3]. Wang further teaches the step of establishing the current-potential profile includes obtaining a LSV [linear sweep voltammogram] based on a current density, as seen in Fig. 3A and Fig. 4A [see Figs. 3-4]. The current density is obtained by normalizing the current response (i) with a geometric surface area of the working electrode (A) [Page 71, Col. 2, Para. 3 and Page 76, Col. 1, Para. 3].
Modified A-A and Wang are considered analogous art to the claimed invention because they are in the same field of electrochemical measurements [Abstract of A-A and Page 71, Col. 1, Para. 2 of Wang]. 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 A-A, which includes establishing a I-V profile by obtaining a linear sweep voltammogram, to be based on a current density, wherein the current density is obtained by normalizing the current response with a geometric surface area of the working electrode, as taught by Wang, since Wang teaches this suitable alternative method of plotting the electrochemical results in linear sweep voltammetry [Figs. 3-4 and Page 71, Col. 2, Para. 3 of Wang]. Furthermore, the use of a known technique (i.e., LSV plotted as current density vs potential, taught by Wang) to improve similar methods in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wang et al. (US20150293048A1) discloses a device 100 to record a voltammogram of chemical agents (analytes) present in the sample; the chemical residues can include, but is not limited to, explosive agents, nerve agents, toxins, pathogens, contaminants, and biological materials and Wang further teaches a system 110 can further include a remote computer in communication with the portable device via a communication network or link to receive the processed data including the classified chemical information from the portable device and to process the classified chemical information in a data library of previously collected samples [Para. 0051, 0047, 0017 and Fig. 1A-1D of Wang]. Gao et al. (Nickel Catalysts Supported on Acetylene Black for High-Efficient Electrochemical Oxidation and Sensitive Detection of Glucose, 28 January 2020, Nano Express, 15, Pages 1-9) discloses electrochemical detection of glucose where all current densities were normalized to the geometrical area of the electrode, the working electrode being a glassy carbon electrode for glucose sensing [Abstract, Title; Page 3, Col 2. Para. 1, see also Fig. 3 and 4 showing linear sweep voltammetric curves].
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/S.Y.O./Examiner, Art Unit 1794
/JAMES LIN/Supervisory Patent Examiner, Art Unit 1794
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