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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/25/2022 has been considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities:
Claim 1, line 6: please amend “determining the concentration” to –determining the glucose concentration—for purposes of consistency.
Claim 1, line 8: please amend “the serum sample contains the glucose at a” to --the serum sample contains the glucose concentration of the analyte at a -- for purposes of consistency with the preamble.
Claim 13, line 1: please amend “the glucose is present” to -- the glucose concentration of the analyte is present -- for purposes of consistency with the preamble.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 7, claim 7 recites “removing a precipitated protein from the serum sample prior to the immersing”. The amended claim 1 recites the serum sample comprises an inorganic base and a copper or zinc salt. However, the instant specification clearly collects the serum sample from a patient, defrosts the sample, and then treats with methanol to separate the protein prior to the addition of the inorganic base for dilution and the copper salt [see e.g., Page 40, lines 20-25 continued to next page]. The instant specification further discloses that “protein free serum sample diluted 200 times in 0.10 M NaOH…” [see e.g., Page 50, lines 1-10, note the NaOH corresponds to an inorganic base]. The serum sample clearly does not contain nor comprise the inorganic base and copper salt at the same time that the step of removing the precipitated protein is performed. Rather, the raw serum is treated to remove the protein and then add the inorganic base and copper salt in the protein free serum sample. Claim 7 depends on claim 1, and therefore requires that the serum sample comprise an inorganic base and a copper or zinc salt, and to remove the precipitated protein from the serum sample prior to the immersing, which is not supported by the specification and figures. Therefore, claim 7 is new matter. Claims 8-9 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 7.
Regarding claim 8, claim 8 recites “wherein the removing comprises mixing an alcohol with the serum sample to produce the precipitated protein and centrifuging the precipitated protein”. The amended claim 1 recites the serum sample comprises an inorganic base and a copper or zinc salt. However, the instant specification clearly collects the serum sample from a patient, defrosts the sample, and then treats with methanol [i.e., the alcohol] to separate the protein prior to the addition of the inorganic base for dilution and the copper salt [see e.g., Page 40, lines 20-25 continued to next page]. The instant specification further discloses that “protein free serum sample diluted 200 times in 0.10 M NaOH…” [see e.g., Page 50, lines 1-10, note the NaOH corresponds to an inorganic base]. The serum sample clearly does not contain nor comprise the inorganic base and copper salt at the same time that the step of removing the precipitated protein by alcohol and centrifugation is performed. Rather, the raw serum is treated to remove the protein by alcohol and centrifugation and then add the inorganic base and copper salt in the protein free serum sample. Claim 8 depends on claim 1, and therefore requires that the serum sample comprise an inorganic base and a copper or zinc salt, and to remove the precipitated protein from the serum sample by mixing an alcohol with the serum sample to produce the precipitated protein and centrifuging the precipitated protein, which is not supported by the specification and figures. Therefore, claim 8 is new matter.
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, 4 and 12-15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 limitation “the aqueous sample” in line 2. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear if the aqueous sample refers to the serum sample, or is a new and different element. Therefore, the scope of claim 2 is indefinite.
Regarding claim 4, claim 4 recites the limitation “the aqueous sample” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear if the aqueous sample refers to the serum sample, or is a new and different element. Therefore, the scope of claim 4 is indefinite.
Regarding claim 12, claim 12 recites “the serum sample comprises Cu2+”. However, claim 1 previously recited the serum sample comprises a copper salt. It is unclear if the Cu2+ of claim 12 is the same element as the copper salt of claim 1, or a new, additional and different element. If they are the same, the examiner suggests amending the claim to recite, for example, “wherein the copper salt comprises Cu2+ at a concentration of…”. Therefore, claim 12 is indefinite. Claims 13-15 is further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 12.
Regarding claim 15, claim 15 recites “the serum sample comprises Cu(NO3)2”. However, claim 1 previously recited the serum sample comprises a copper salt and claim 12 previously recited “the serum sample comprises Cu2+”. It is unclear if the Cu(NO3)2 of claim 15 is the same element as the Cu2+ of claim 12 and/or the copper salt of claim 1, or a new, additional and different element. If all the elements are the same element, the examiner suggests amending the claim to recite, for example, “wherein the copper salt comprising Cu2+ further comprises Cu(NO3)2”. Therefore, claim 15 is indefinite.
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) 1-6, 11-13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pourbeyram et al. (Nonenzymatic glucose sensor based on disposable pencil graphite electrode modified by copper nanoparticles, 2016, Journal of Food and Drug Analysis, 24, 4, Pages 894-902), which is cited in the information disclosure statement (IDS) submitted on 08/25/2022.
Regarding claim 1, a method for determining a glucose concentration of an analyte in a serum sample (Pourbeyram teaches a method for determining glucose concentrations in human blood serum samples [Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Table 2 and Fig. 10]) the method comprising:
immersing a graphite electrode, a reference electrode, and a counter electrode in the serum sample (Pourbeyram teaches electrochemical measurements were performed using a pencil graphite electrode as the working electrode, a platinum auxiliary/counter electrode, and a Ag/AgCl reference electrode, and immersing the electrodes for determination in human blood serum samples [Page 895, Col. 2, Para. 3; Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Table 2 and Fig. 10]);
measuring a current response at a voltage of 0.4 - 0.8 V (Pourbeyram teaches measuring a current response [Ip/μA] under optimal experimental conditions by amperometry, at a voltage/applied potential of 0.55V, falling within the claimed range [Page 898, Col. 2, last paragraph; Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Table 2 and Figs. 9-10]); and
determining the concentration of the analyte in the serum sample by comparing the current response to a correlation chart (Pourbeyram teaches determining the concentration [mM] of the glucose analyte in the human blood serum samples by comparing the current response [Ip/μA] to a correlation chart and calibration curves [Page 899, Col. 1, Paras. 1-4; Page 898, Col. 2, last paragraph; Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Table 2 and Figs. 9-10]),
wherein the serum sample contains the glucose at a concentration of 1.0 μM - 10.0 mM (Pourbeyram teaches the serum sample contains glucose at a concentration of 1 mM during the interference test and at a concentration of 5.43 ± 0.13 mM – 7.52 ± 0.14 mM during the determination of glucose tests in human blood serum samples, falling within the claimed range [Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Table 2 and Fig. 10]),
wherein the serum sample comprises an inorganic base at a concentration of 0.02 - 1.0 M (Pourbeyram teaches the human blood serum samples were diluted with 0.1 M NaOH solution [an inorganic base], the inorganic NaOH base at a concentration of 0.1M, falling within the claimed range [Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1]) and
a copper salt (Pourbeyram teaches immersing a graphite electrode in a serum sample solution [i.e., electrolyte] where the graphite electrode is prepared by a copper nitrate solution by immersing the electrode and then drying overnight, and thus the electrode contains both copper and nitrates. This is further evidenced by Pourbeyram disclosing that the Cu(II)/Cu(III) redox couples from the electrode in solution [including the serum solution] enhance the nonenzymatic electro-oxidation of glucose as a result of Cu(II)/Cu(III)’s electrocatalytic effect and mediation on electron transfer for the nonenzymatic oxidation of glucose. The serum sample solution [i.e., electrolyte] in contact with the Cu(NP) graphite electrode contains copper species participating in mediation of glucose oxidation including Cu(II)/Cu(III) species [i.e., Cu2+/Cu3+]. Furthermore, Pourbeyram discloses the serum sample [which contains chlorides as serum contains chloride ions] further contains a NaOH solution, thus the serum sample solution comprises the counterions OH- and Cl- as well as nitrate ions from the electrode, because the electrode is in contact with the serum sample solution [electrolyte]. Copper salts in an electrolyte solution are interpreted as copper ions [Cu2+/Cu3+] and counterions [OH-, Cl- and nitrate] dissolved in solution. Thus, Pourbeyram teaches copper ionic species during electrochemical operation and the electrolyte solution [serum sample] in contact with the electrode comprises copper from the Cu(II)/Cu(III) [i.e., Cu2+/Cu3+] species and the counterions hydroxides [from NaOH], chlorides [from the serum sample], and nitrates [from the copper nitrate solution dried onto the electrode]. Therefore, the serum sample solution [electrolyte] which is in contact with the graphite electrode comprises a copper salt [see e.g., Page 895, Col. 1, last paragraph; Page 895, Col. 2, Paras. 1-3; Page 896, Col. 1, last paragraph continued to next page; Page 897, Col. 2, Paras. 2-6; Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Page 901, Col. 1, last paragraph])
at a concentration of 0.1 - 10 ppm (Regarding the concentration of the copper salt, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP § 2144.05(II)(A). Therefore, it would have been obvious to one skilled in the art to use a concentration of 0.1 - 10 ppm for the copper salt as this would function is a predictable manner given these conditions.
In the alternative, Pourbeyram teaches the presence of Cu(II)/Cu(III) [i.e., Cu2+/Cu3+] species, which necessarily has a concentration, affects the nonenzymatic oxidation of glucose, electron transfer and peak current, as well as the electrochemical determination of glucose, especially in comparison to an electrode without any copper and thus the change in concentration of Cu(II)/Cu(III) [compared to zero concentration] affects the aforementioned variables [Page 895, Col. 1, Para. 1; Page 897, Col. 2, Paras 2-5; Figure 2]. Changes in the concentration of Cu(II)/Cu(III) species [i.e., Cu2+/Cu3+] changes the concentration of the copper salt. Thus, changing the concentration of the copper salt will change the concentration of Cu2+/Cu3+, which affects the nonenzymatic oxidation of glucose, electron transfer and peak current, and the electrochemical determination of glucose. Therefore, the concentration of copper salt is a results effective variable.
As the nonenzymatic oxidation of glucose, electron transfer and peak current, as well as the electrochemical determination of glucose are variables that can be modified (Page 895, Col. 1, Para. 1; Page 897, Col. 2, Paras 2-5; Figure 2 of Pourbeyram), among others, by adjusting the concentration of copper salt, the precise concentration of copper salt would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed concentration of 0.1 - 10 ppm of the copper salt cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the concentration of copper salt in Pourbeyram to obtain the desired balance between the nonenzymatic oxidation of glucose, electron transfer and peak current, as well as the electrochemical determination of glucose, as taught by Pourbeyram. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 2, the method of claim 1, wherein the inorganic base is NaOH, and the aqueous sample has a pH of 12.0 - 14.0 (Pourbeyram teaches the inorganic base is NaOH, and the sample has a pH of 13, falling within the claimed range, as pH 13 was selected as the optimized value for glucose determination and the serum samples were measured under optimal experimental conditions [Page 898, Col. 1, Para. 1; Figure 6; Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; see rejection of claim 1 above].
Regarding claim 3, the method of claim 1, wherein the graphite electrode has no surface modification prior to the immersing (Pourbeyram teaches the graphite electrode is not surface modified to immobilize an enzyme such as glucose oxidase and does not adsorb molecules, such as enzymes, onto the surface of the graphite electrode prior to the immersing, and thus it has no surface modification of functionalizing the electrodes with enzymes prior to the immersing as it is a nonenzymatic graphite electrode and glucose sensor [Title, Abstract, Page 897, Col. 2, Para. 3; Page 901, Col. 1, Para. 1, Fig. 10 and Table 2]).
Regarding claim 4, the method of claim 1, wherein the graphite electrode has a diameter or width of 0.1 - 2.0 mm and a length of 3.0 - 20.0 mm in contact with the aqueous sample after the immersing (Pourbeyram teaches the graphite electrode has a diameter of 0.5 mm, which falls within the claimed range. Pourbeyram further teaches the electrode was inserted into a tube exposing 0.5 cm of its tip [corresponding to a length of 0.5 cm in contact with the aqueous sample after immersing], 0.5 cm being equivalent to 5 mm, falling within the claimed range. Thus, Pourbeyram teaches the electrode which exposed 5 mm of its length/tip has a length of 5mm and a diameter of 0.5 mm, which would be in contact with the aqueous sample after the immersing [Page 895, Col. 2, Paras. 2-3]).
Regarding claim 5, the method of claim 1, wherein the serum sample further comprises at least one selected from the group consisting of ascorbic acid, alanine, fructose, uric acid, and cysteine, each independently at a concentration of 0.01 - 1.00 mM (Pourbeyram teaches the human blood serum samples further comprises ascorbic acid and uric acid, each at a concentration of 0.1 mM, falling within the claimed range [Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Fig. 10]).
Regarding claim 6, the method of claim 1, wherein the reference electrode is an Ag/AgCl electrode, and the counter electrode comprises platinum (Pourbeyram teaches a platinum auxiliary/counter electrode and a Ag/AgCl reference electrode [Page 895, Col. 2, Para. 3; Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Table 2 and Fig. 10]).
Regarding claim 11, the method of claim 1, further comprising constructing a calibration curve from a current response of two or more standard solutions (Pourbeyram teaches constructing calibration curves [Ip/μA vs. Glucose (mM)] from a current response [Ip/μA] of more than two standard solutions of glucose, in the concentration range from 0.5 mM to 100.0 mM and 1.0 mM to 100 μM [Fig. 9 and caption; Page 899, Col. 1, Paras. 1-4; Page 898, Col. 2, last paragraph]).
Regarding claim 12, the method of claim 1, wherein the serum sample comprises Cu2+ (As outlined in the rejection of claim 1 above, Pourbeyram teaches immersing a graphite electrode in a serum sample solution [i.e., electrolyte] where the graphite electrode is prepared by a copper nitrate [comprising Cu2+] solution by immersing the electrode and then drying overnight, and thus the electrode contains both copper [such as Cu2+] and nitrates. This is further evidenced by Pourbeyram disclosing that the Cu(II)/Cu(III) redox couples from the electrode in solution [including the serum solution] enhance the nonenzymatic electro-oxidation of glucose as a result of Cu(II)/Cu(III)’s electrocatalytic effect and mediation on electron transfer for the nonenzymatic oxidation of glucose. The serum sample solution [i.e., electrolyte] in contact with the Cu(NP) graphite electrode contains copper species participating in mediation of glucose oxidation including Cu(II)/Cu(III) species [i.e., Cu2+/Cu3+]. Thus, Pourbeyram teaches copper ionic species during electrochemical operation and the electrolyte solution [serum sample] in contact with the electrode comprises copper species from the Cu(II)/Cu(III) species and the counterions hydroxides [from NaOH], chlorides [from the serum sample], and nitrates [from the copper nitrate solution dried onto the electrode]. Therefore, the serum sample solution [electrolyte] which is in contact with the graphite electrode comprises Cu2+ from the Cu(II)/Cu(III) species [i.e., Cu2+/Cu3+] which mediates the oxidation of glucose as outlined above, and from the copper nitrate solution used to fabricate the electrode [see e.g., Page 895, Col. 1, last paragraph; Page 895, Col. 2, Paras. 1-3; Page 896, Col. 1, last paragraph continued to next page; Page 897, Col. 2, Paras. 2-6; Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Page 901, Col. 1, last paragraph; see rejection of claim 1 above])
at a concentration of 1 - 5 ppm (Regarding the concentration of Cu2+, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP § 2144.05(II)(A). Therefore, it would have been obvious to one skilled in the art to use a concentration of 1-5 ppm for Cu2+ as this would function is a predictable manner given these conditions.
In the alternative, as outlined in the rejection of claim 1 above, the concentration of Cu(II)/Cu(III) [i.e., Cu2+/Cu3+] species is a results effective variable. Pourbeyram teaches the presence of Cu(II)/Cu(III) [i.e., Cu2+/Cu3+] species, which necessarily has a concentration, affects the nonenzymatic oxidation of glucose, electron transfer and peak current, as well as the electrochemical determination of glucose, especially in comparison to an electrode without any copper and thus the change in concentration of Cu(II)/Cu(III) [compared to zero concentration] affects the aforementioned variables [Page 895, Col. 1, Para. 1; Page 897, Col. 2, Paras 2-5; Figure 2; see rejection of claim 1 above]. Changes in the concentration of Cu(III) in the Cu(II)/Cu(III) redox pair, will change the concentration of Cu2+. Thus, changing the concentration of Cu2+ will change the concentration of Cu2+/Cu3+, which affects the nonenzymatic oxidation of glucose, electron transfer and peak current, and the electrochemical determination of glucose. Therefore, the concentration of Cu2+ is a results effective variable.
As the nonenzymatic oxidation of glucose, electron transfer and peak current, as well as the electrochemical determination of glucose are variables that can be modified (Page 895, Col. 1, Para. 1; Page 897, Col. 2, Paras 2-5; Figure 2 of Pourbeyram), among others, by adjusting the concentration of Cu2+, the precise concentration of Cu2+ would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed concentration of 1-5 ppm of Cu2+ cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the concentration of Cu2+ in Pourbeyram to obtain the desired balance between the nonenzymatic oxidation of glucose, electron transfer and peak current, as well as the electrochemical determination of glucose, as taught by Pourbeyram. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 13, the method of claim 12, wherein the glucose is present in the serum sample at a concentration of 0.06 - 4.0 mM (As outlined in the rejections of claims 1 and 12 above, Pourbeyram teaches the serum sample contains glucose at a concentration of 1 mM during the interference test and at a concentration of 5.43 ± 0.13 mM – 7.52 ± 0.14 mM during the determination of glucose tests in human blood serum samples, the concentration of 1mM glucose and 5.43 ± 0.13 mM – 7.52 ± 0.14 mM glucose overlapping the claimed range [Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Table 2 and Fig. 10]. Furthermore, Pourbeyram teaches the amperometric signals in the sensor showed a linear correlation to glucose concentrations in the range from 0.1mM to 100.0mM [falling within the claimed range] and from 1.0μM to 100.0μM [overlapping the claimed range] glucose [see e.g., Page 899, Col. 1, Paras. 1-4; Page 898, Col. 2, last paragraph and Fig. 9]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected and utilized a glucose concentration present in the serum sample within the disclosed range, as taught by Pourbeyram, including those amounts that overlap within the claimed range, since one of ordinary skill in the art would reasonably expect any value within the taught range to be suitable given that Pourbeyram specifically teaches the range to be suitable for the glucose concentration present in the human serum samples [Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Table 2 and Fig. 10]. It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 [I].
Furthermore, regarding the glucose present at a concentration of 0.06 – 4.0 mM, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP § 2144.05(II)(A). Therefore, it would have been obvious to one skilled in the art to use a concentration of glucose present at a concentration of 0.1 – 4.0 mM, falling within the claimed range, as this would function is a predictable manner given these conditions, as Pourbeyram specifically teaches the amperometric signals in the sensor showed a linear correlation to glucose concentrations in the range from 0.1mM to 100.0mM and from 1.0μM to 100.0μM glucose [see e.g., Page 899, Col. 1, Paras. 1-4; Page 898, Col. 2, last paragraph and Fig. 9].
Regarding claim 15, the method of claim 12, wherein the serum sample comprises Cu(NO3)2 (As outlined in the rejections of claims 1 and 12 above, Pourbeyram teaches immersing a graphite electrode in a serum sample solution [i.e., electrolyte] where the graphite electrode is prepared by a copper nitrate solution by immersing the electrode and then drying overnight, and thus the electrode contains both copper and nitrates. This is further evidenced by Pourbeyram disclosing that the Cu(II)/Cu(III) redox couples from the electrode in solution [including the serum solution] enhance the nonenzymatic electro-oxidation of glucose as a result of Cu(II)/Cu(III)’s electrocatalytic effect and mediation on electron transfer for the nonenzymatic oxidation of glucose. The serum sample solution [i.e., electrolyte] in contact with the Cu(NP) graphite electrode contains copper species participating in mediation of glucose oxidation including Cu(II)/Cu(III) species [i.e., Cu2+/Cu3+] and the serum sample solution comprises copper ions and nitrate ions from the electrode, because the electrode is in contact with the serum sample solution [electrolyte] and the salt [copper nitrate, Cu(NO3)2] on the electrode dissolves in solution to provide Cu2+ and NO3- ions [corresponding to Cu(NO3)2/copper nitrate]. Cu(NO3)2 in an electrolyte solution [i.e., serum sample in NaOH] are interpreted as copper ions [Cu2+] and counterion [nitrate, NO3-] dissolved in solution. Therefore, the serum sample solution [electrolyte] which is in contact with the graphite electrode comprises Cu(NO3)2 [see e.g., Page 895, Col. 1, last paragraph; Page 895, Col. 2, Paras. 1-3; Page 896, Col. 1, last paragraph continued to next page; Page 897, Col. 2, Paras. 2-6; Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Page 901, Col. 1, last paragraph]
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pourbeyram et al. as applied to claim 1 above, and further in view of Kawde et al. (Cathodized Gold Nanoparticle-Modified Graphite Pencil Electrode for Non-Enzymatic Sensitive Voltammetric Detection of Glucose, 2017, Electroanalysis, 29, 5, Pages 1214-1221).
Regarding claim 7, the method of claim 1, Pourbeyram does not explicitly disclose further comprising removing a precipitated protein from the serum sample prior to the immersing.
Kawde discloses an enzymeless electrochemical glucose sensor with a graphite pencil electrode [Abstract and Title]. Kawde teaches the fabricated sensor was tested in a human serum sample and the real sample was collected from the healthy person, wherein the concentration of glucose in the serum was determined in the diluted real samples [Page 1220, Col. 1, Para. 1]. Kawde further teaches in order to prepare the samples, the proteins were removed and the collected human serum samples were treated with methanol [an alcohol] to produce precipitated proteins and remove the proteins, centrifuging the precipitated proteins, and removing the precipitated proteins by decantation before immersing/analyzing the sample [Page 1216, Col. 1, Para. 3; Page 1220, Col. 1, Para. 1].
Pourbeyram and Kawde are considered analogous art to the claimed invention because they are in the same field of nonenzymatic glucose sensors [Titles and Abstracts of Pourbeyram and Kawde]. 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 Pourbeyram to include removing a precipitated protein from the serum sample prior to the immersing and analysis, wherein the removing comprises mixing methanol [an alcohol] with the serum sample to produce the precipitated protein, and centrifuging the precipitated protein, as taught by Kawde, since Kawde teaches this suitable configuration and method for preparing a collected human sample serum before determining the glucose present in the diluted serum with a graphite electrode in an enzymeless glucose sensor [Page 1216, Col. 1, Para. 3; Page 1220, Col. 1, Para. 1; Abstract of Kawde]. Furthermore, the use of a known technique (i.e., the collected human serum samples were treated with methanol [an alcohol] to produce precipitated proteins and remove the proteins, centrifuging the precipitated proteins, and removing the precipitated proteins by decantation before immersing/analyzing the sample, taught by Kawde) 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]).
Regarding claim 8, the method of claim 7, wherein the removing comprises mixing an alcohol with the serum sample to produce the precipitated protein, and centrifuging the precipitated protein (As outlined in the rejection of claim 7 above, modified Pourbeyram teaches the removing the precipitated protein includes mixing methanol “alcohol” with the human serum sample to produce the precipitated protein and centrifuging the precipitated protein [see rejection of claim 7 above and Kawde: Page 1216, Col. 1, Para. 3; Page 1220, Col. 1, Para. 1]).
Regarding claim 9, the method of claim 7, wherein the serum sample is derived from a human donor (As outlined in the rejection of claims 1 and 7 above, Pourbeyram teaches the serum sample is a human blood serum sample, and thus derived from a human donor [see rejections of claims 1 and 7 above; Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Table 2 of Pourbeyram]).
Claim(s) 10 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pourbeyram et al. as applied to claims 1 and 12 above, respectively, and further in view of Babu et al. (Development of highly sensitive non-enzymatic sensor for the selective determination of glucose and fabrication of a working model, 2010, Electrochimica Acta, 55, Pages 1612–1618).
Regarding claim 10, the method of claim 1, Pourbeyram does not explicitly disclose wherein the measuring involves applying linear scan voltammetry to the serum sample.
However, Pourbeyram discloses measuring a current response [I/μA and Ip/μA] under optimal experimental conditions by amperometry to the human serum samples [Page 898, Col. 2, last paragraph; Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Table 2 and Figs. 9-10]).
Babu discloses a non-enzymatic electrochemical sensor for the detection of glucose in alkaline medium [Abstract]. Babu teaches that linear sweep voltammetry (LSV) [which corresponds to linear scan voltammetry] and amperometry were adopted to investigate glucose, and the measuring step includes measuring a current response at a voltage of 0 V – 0.7 V, which overlaps the claimed range, and the measuring involves applying linear scan voltammetry in the presence of glucose [Figs. 5 and 6, Abstract; Page 1615, Col. 2, Para. 1; Page 1616, Col. 1, Para. 1].
Pourbeyram and Babu are considered analogous art to the claimed invention because they are in the same field of nonenzymatic glucose sensors [Titles and Abstracts of Pourbeyram and Babu]. 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 applied amperometry electroanalytical technique in Pourbeyram, which measures a current response in the presence of a glucose analyte at a specific voltage to the human serum samples, with an applied LSV electroanalytical measurement technique that measures a current response in the presence of a glucose analyte at a voltage of 0V – 0.7 V, as taught by Babu, since Babu teaches LSV is a suitable measurement technique for a non-enzymatic electrochemical sensor that detects glucose in alkaline medium and either linear sweep voltammetry (LSV) [which corresponds to linear scan voltammetry] or amperometry can be adopted to measure glucose [Figs. 5 and 6, Abstract; Page 1615, Col. 2, Para. 1; Page 1616, Col. 1, Para. 1 of Babu]. Furthermore, the simple substitution of one known element for another (i.e., an amperometric electroanalytical technique with a LSV electroanalytical technique) is likely to be obvious when predictable results are achieved (i.e., determining glucose/analyte concentrations from the measured current in response to the applied potential) [MPEP 2143[I][B]].
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected and utilized a voltage within the disclosed range, as taught by Babu, including those amounts that overlap within the claimed range, since one of ordinary skill in the art would reasonably expect any value within the taught range to be suitable given that Babu specifically teaches the range to be suitable for the applied voltage [see e.g., Figs. 5 and 6; Page 1615, Col. 2, Para. 1; Page 1616, Col. 1, Para. 1 of Babu]. It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 [I].
Regarding claim 14, the method of claim 12, Pourbeyram does not explicitly disclose wherein the voltage is 0.60 - 0.65 V.
However, Pourbeyram discloses measuring a current response [I/μA and Ip/μA] under optimal experimental conditions by amperometry to the human serum samples [Page 898, Col. 2, last paragraph; Page 899, Col. 2, Paras. 2-3; Page 901, Col. 1, Para, 1; Table 2 and Figs. 9-10]).
Babu discloses a non-enzymatic electrochemical sensor for the detection of glucose in alkaline medium [Abstract]. Babu teaches that linear sweep voltammetry (LSV) [which corresponds to linear scan voltammetry] and amperometry were adopted to investigate glucose, and the measuring step includes measuring a current response at a voltage of 0 V – 0.7 V, which overlaps the claimed range, and the measuring involves applying linear scan voltammetry in the presence of glucose [Figs. 5 and 6, Abstract; Page 1615, Col. 2, Para. 1; Page 1616, Col. 1, Para. 1].
Pourbeyram and Babu are considered analogous art to the claimed invention because they are in the same field of nonenzymatic glucose sensors [Titles and Abstracts of Pourbeyram and Babu]. 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 applied amperometry electroanalytical technique in Pourbeyram, which measures a current response in the presence of a glucose analyte at a specific voltage to the human serum samples, with an applied LSV electroanalytical measurement technique that measures a current response in the presence of a glucose analyte at a voltage of 0V – 0.7 V, as taught by Babu, since Babu teaches LSV is a suitable measurement technique for a non-enzymatic electrochemical sensor that detects glucose in alkaline medium and either linear sweep voltammetry (LSV) [which corresponds to linear scan voltammetry] or amperometry can be adopted to measure glucose [Figs. 5 and 6, Abstract; Page 1615, Col. 2, Para. 1; Page 1616, Col. 1, Para. 1 of Babu]. Furthermore, the simple substitution of one known element for another (i.e., an amperometric electroanalytical technique with a LSV electroanalytical technique at an applied voltage of 0 V – 0.7 V) is likely to be obvious when predictable results are achieved (i.e., determining glucose/analyte concentrations from the measured current in response to the applied potential) [MPEP 2143[I][B]].
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected and utilized a voltage within the disclosed range, as taught by Babu, including those amounts that overlap within the claimed range, since one of ordinary skill in the art would reasonably expect any value within the taught range to be suitable given that Babu specifically teaches the range to be suitable for the applied voltage [see e.g., Figs. 5 and 6; Page 1615, Col. 2, Para. 1; Page 1616, Col. 1, Para. 1 of Babu]. It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 [I].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over respective claims 1-20 of U.S. Patent No. U.S. 11,474,067 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the U.S. Patent No. U.S. 11,474,067 B2, especially claim 12, effectively anticipate the invention as claimed in instant claims 1 and 12-15.
Instant claim 1 is anticipated by claim 12 of the ‘067 patent since patent ‘067 describes “a method of measuring a concentration of an analyte in an aqueous sample, the method comprising: immersing a graphite electrode, a reference electrode, and a counter electrode in the aqueous sample; measuring a current response at a voltage of 0.4-0.8 V; and determining the concentration of the analyte in the aqueous sample by comparing the current response to a correlation chart, wherein the analyte is glucose at a concentration of 1.0 μM-10.0 mM” in claim 1, “wherein the aqueous sample comprises an inorganic base at a concentration of 0.02-1.0 M and a metal salt at a concentration of 0.1-10 ppm, wherein the metal salt comprises at least one metal ion selected from the group consisting of Cu2+ and Zn2+” [corresponding to a copper or zinc salt] in claim 1 and “wherein the metal salt comprises Cu2+” [corresponding to a copper salt] in claim 12, “the Cu2+ having a concentration of 1-5 ppm in the aqueous sample” in claim 12. The aqueous sample corresponds to the serum sample of instant claim 1. The measuring a concentration of an analyte corresponds to a method for determining a glucose concentration of an analyte of instant claim 1.
Instant claim 2 is obvious over claims 2 and 12 of the ‘067 patent since patent ‘067 describes “wherein the inorganic base is NaOH, and the aqueous sample has a pH of 12.0-14.0” in claim 2. It would have been obvious to combine different dependent claims to achieve the different benefits of the different dependent claims in a single embodiment.
Instant claim 3 is obvious over claims 3 and 12 of the ‘067 patent since patent ‘067 describes “wherein the graphite electrode has no surface modification prior to the immersing” in claim 3. It would have been obvious to combine different dependent claims to achieve the different benefits of the different dependent claims in a single embodiment.
Instant claim 4 is obvious over claims 4 and 12 of the ‘067 patent since patent ‘067 describes “wherein the graphite electrode has a diameter or width of 0.1-2.0 mm and a length of 3.0-20.0 mm in contact with the aqueous sample after the immersing” in claim 4. It would have been obvious to combine different dependent claims to achieve the different benefits of the different dependent claims in a single embodiment.
Instant claim 5 is obvious over claims 5 and 12 of the ‘067 patent since patent ‘067 describes “wherein the aqueous sample further comprises at least one selected from the group consisting of ascorbic acid, alanine, fructose, uric acid, and cysteine, each independently at a concentration of 0.01-1.00 mM” in claim 5. The aqueous sample corresponds to the serum sample of instant claim 5. It would have been obvious to combine different dependent claims to achieve the different benefits of the different dependent claims in a single embodiment.
Instant claim 6 is obvious over claims 6 and 12 of the ‘067 patent since patent ‘067 describes “wherein the reference electrode is an Ag/AgCl electrode, and the counter electrode comprises platinum” in claim 6. It would have been obvious to combine different dependent claims to achieve the different benefits of the different dependent claims in a single embodiment.
Instant claim 7 is obvious over claims 7 and 12 of the ‘067 patent since patent ‘067 describes “removing a precipitated protein from the aqueous sample prior to the immersing, wherein the aqueous sample further comprises serum” in claim 7. The aqueous sample corresponds to the serum sample of instant claim 7. It would have been obvious to combine different dependent claims to achieve the different benefits of the different dependent claims in a single embodiment.
Instant claim 8 is obvious over claims 8 and 12 of the ‘067 patent since patent ‘067 describes “wherein the removing comprises mixing an alcohol with the serum to produce the precipitated protein, and centrifuging the precipitated protein” in claim 8. It would have been obvious to combine different dependent claims to achieve the different benefits of the different dependent claims in a single embodiment.
Instant claim 9 is obvious over claims 9 and 12 of the ‘067 patent since patent ‘067 describes “wherein the serum is derived from a human donor” in claim 9. It would have been obvious to combine different dependent claims to achieve the different benefits of the different dependent claims in a single embodiment.
Instant claim 10 is obvious over claims 10 and 12 of the ‘067 patent since patent ‘067 describes “wherein the measuring involves applying linear scan voltammetry to the aqueous sample” in claim 10. The aqueous sample corresponds to the serum sample of instant claim 10. It would have been obvious to combine different dependent claims to achieve the different benefits of the different dependent claims in a single embodiment.
Instant claim 11 is obvious over claims 11 and 12 of the ‘067 patent since patent ‘067 describes “constructing a calibration curve from a current response of two or more standard solutions” in claim 11. It would have been obvious to combine different dependent claims to achieve the different benefits of the different dependent claims in a single embodiment.
Instant claim 12 is anticipated by claim 12 of the ‘067 patent since patent ‘067 describes “wherein the metal salt comprises Cu2+” [corresponding to a copper salt] in claim 12, “the Cu2+ having a concentration of 1-5 ppm in the aqueous sample” in claim 12. The aqueous sample corresponds to the serum sample of instant claim 12.
Instant claim 13 is anticipated by claim 13 [which depends on claim 12] of the ‘067 patent since patent ‘067 describes “wherein the glucose is present in the aqueous sample at a concentration of 0.06-4.0 mM” in claim 13. The aqueous sample corresponds to the serum sample of instant claim 13.
Instant claim 14 is anticipated by claim 14 [which depends on claim 12] of the ‘067 patent since patent ‘067 describes “wherein the voltage is 0.60-0.65 V” in claim 14.
Instant claim 15 is anticipated by claim 15 [which depends on claim 12] of the ‘067 patent since patent ‘067 describes “wherein the aqueous sample comprises a metal salt at a concentration of 0.1-10 ppm, wherein the metal salt comprises at least one metal ion selected from the group consisting of Cu2+ and Zn2+” [corresponding to a copper or zinc salt] in claim 1, “wherein the metal salt comprises Cu2+” [corresponding to a copper salt] in claim 12, “wherein the metal salt is Cu(NO3)2 in claim 15. The aqueous sample corresponds to the serum sample of instant claim 15.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kawde et al. (US20150285756A1) teaches the PGE is modified with copper from solution of 0.1 M CuSO4 in 0.1 M acetate buffer (0.1 M, pH 4.8) by electrodeposition at −1.0 V for 60 seconds and the CVs were recorded in acetate buffer (0.1 M, pH 4.8) in the absence (curve “a” in FIG. 1C) and presence (curve “b” in FIG. 1C) of 1 mM 4-NP [Para. 0023].
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/S.Y.O./Examiner, Art Unit 1794
/JAMES LIN/Supervisory Patent Examiner, Art Unit 1794
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