DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of claims 1-10 in the reply filed on 02/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
This application is claiming the benefit of provisional application No. 63/323,320 under 35 U.S.C. 119(e). However, this application was not filed within twelve months from the filing date of the provisional application, and there is no indication of an intermediate nonprovisional application or international application designating the United States that is directly claiming the benefit of the provisional application and filed within 12 months of the filing date of the provisional application. In addition, no petition under 37 CFR 1.78(b) or request under PCT Rule 26bis.3 to restore the benefit of the provisional application has been granted.
Applicant is required to delete the claim to the benefit of the prior-filed provisional application, unless applicant can establish that this application, or an intermediate nonprovisional application or international application designating the United States, was filed within 12 months of the filing date of the provisional application. See 35 U.S.C. 119(e)(3). Alternatively, applicant may wish to file a petition to restore the benefit of the provisional application under 37 CFR 1.78 in the subsequent nonprovisional application or international application designating the United States if the subsequent application was filed within two months from the expiration of the twelve-month period and the delay was unintentional. A petition under 37 CFR 1.78(b) to restore the benefit of the provisional application must include: (1) the reference required by 35 U.S.C. 119(e) and 37 CFR 1.78 to the prior-filed provisional application (unless previously submitted); (2) the petition fee set forth in 37 CFR 1.17(m)(3); and (3) a statement that the delay in filing the subsequent nonprovisional application or international application designating the United States within the twelve-month period was unintentional. A petition to restore the benefit of a provisional application must be filed in the subsequent application. The Director may require additional information where there is a question whether the delay was unintentional. The petition should be addressed to: Mail Stop Petition, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450.
The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and § 1.78(d) in the application is more than six years before the actual filing date of the application.
Claim Objections
Claims 1 and 5 are objected to because of the following informalities:
claim 1, line 5, “a layer powders” should read “a layer of powders”;
claim 5, line 3, “5mintues” should read “5 minutes”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation " a layer powders of selected from the group of graphene and active carbon coated with potassium ferrocyanide" in lines 5-6. It is unclear whether the options of the group are (1) “graphene” and “active carbon coated with potassium ferrocyanide” or (2) “graphene” and “active carbon” each coated with potassium ferrocyanide. Clarification is requested. For the purpose of examination, it is being interpreted the options of the groups are “graphene” and “active carbon” each coated with potassium ferrocyanide based on para. 00066 of the specification.
Claims 2-10 are indefinite because of their dependency on claim 1.
Claim Rejections - 35 USC § 103
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.
Claim 1 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (US 20190313944 A1) in view of Sõritski et al. (WO 2022101797 A1).
Regarding claim 1, Sun teaches a biomaterial sensitized sensor (Fig. 13A) for testing a virus, comprising:
a layer of substrate (Silicon/SiO2);
a layer of conducting metal electrode (chromium) being disposed on the surface of the layer of substrate (Fig. 13A);
a layer of powders of selected from the group of graphene and active carbon coated with potassium ferrocyanide (para. 0007, 0142 and 0154, graphene with Prussian Blue which is potassium ferrocyanide), being disposed on the surface of the layer of conducting metal electrode;
a layer of molecularly imprinted polymer (MIP) being disposed on the surface of the layer of powders (Fig. 13A);
wherein the layer of MIP is made by imprinting with a template biomarker molecule material in mixture with a functional monomer chemical material through a step of washing (Fig. 13A and para. 0078, 0173 and 0185).
Sun teaches a MIP-based sensor for detecting biomarkers. Sun teaches the MIP layer is a made with Alzheimer biomarkers as the template molecules (paras. 0078, 0173). Sun further teaches MIPs selective for compounds up to about 3,000 daltons are routinely prepared, MIPs selective for larger analytes, such as peptides, carbohydrates and proteins, can also be prepared (para. 0083). Sun teaches that the MIP is prepared by cyclic voltammetry (para. 0155)
Sun does not teach the biomarker molecules material is a virus material, and thus fails to teach wherein the MIP is made by imprinting with a template virus material in mixture with a functional monomer (pyrrole) chemical material through a step of washing.
However, Sõritski teaches a MIP-sensor for the detection of SARS-CoV-2 (abstract) through detecting SARS-CoV-2 nucleoprotein (ncovNP) and/or SARS-CoV-2 spike 1 (S1). Sõritski teaches the MIP-sensor comprises a MIP synthesized electrochemically by cyclic voltammetry (abstract). Sõritski the MIP is made by imprinting with a template ncovNP and/or ncovS1 (virus material) in mixture with a functional monomer chemical material comprising dopamine (abstract, p.10, last para and p. 11, 1st para.) through a step of washing (abstract and pp. 17-18).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the MIP taught by Sun with the MIP made by imprinting with a template ncovNP and/or ncovS1 (virus material) with a functional monomer chemical material comprising dopamine taught by Sõritski in order to create a sensor for the detection of SARS-CoV-2 with a reasonable expectation of success (Sõritski, abstract) (MPEP 2143)(I)(G).
Regarding claim 7, modified Sun teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Sun further teaches wherein the functional monomer chemical material is dopamine or dopamine hydrochloride (Sõritski, p. 11, first para., dopamine).
Regarding claim 8, modified Sun teaches all of the elements of the current invention as stated above with respect to claim 7. Modified Sun further teaches wherein the polymer layer is formed on the surface of the layer of graphene through cyclic voltammetry induced electropolymerization (Sun, para. 0023, 0185 and Sõritski, abstract).
Regarding claim 9, modified Sun teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Sun further teaches wherein the virus template material comprises a protein or pathogen particles selected from the group of .
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (US 20190313944 A1) in view of Sõritski et al. (WO 2022101797 A1) as applied to claim 1, and further in view of Kingsborough et al. (US 7102156 B1).
Regarding claim 2, modified Sun teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Sun further wherein the layer of substrate is either glass or silicon (para. 0062 and Fig. 13 A, substrate is silicon with a SiO2 layer on top),
Modified Sun teaches the layer of conducting metal electrode is made of chromium and thus fails to teach the layer of conducting metal electrode is made of a metal selected from the group of Ni-Cu alloy and Cu-Mn-Ni alloy.
However, Kingsborough teaches a device with electrode 132 on a substrate 134 (Fig. 7). Kingsborough further teaches electrode 132 can be formed of any of a number of materials including chromium and nickel-copper alloy (col. 4, lns. 41-56).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted chromium as the layer of conducting metal electrode on a substrate as taught by Sun with nickel-copper alloy as taught by Kingsborough because one of ordinary skill in the art would accordingly have recognized the whether chromium or nickel-copper alloy would result in the predictable result of providing an electrode on a substrate.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (US 20190313944 A1) in view of Sõritski et al. (WO 2022101797 A1) as applied to claim 1, and further in view of Yang (US 20170346098 A1).
Regarding claim 3, modified Sun teaches all of the elements of the current invention as stated above with respect to claim 1.
Sun teaches the layer of powder comprising graphene and Prussian Blue is obtained by vacuum-drying (para. 0152), and thus fails to teach the layer of powders is made from powders obtained by a freeze-drying process.
However, Yang teaches graphene obtained by reduction is appropriately washed, and then dried to give a graphene powder. Yang further teaches to alleviate the issue of graphene being aggregated during the drying, and thus lowering the specific surface area, vacuum drying is preferred, and freeze drying is more preferred, as compared to normal pressure heat drying (para. 0058).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drying method of vacuum drying taught by Sun with freeze drying taught by Yang in order to have a more preferred drying method to further alleviate issues of graphene aggregating during drying with a reasonable expectation of success (Yang, para. 0058) (MPEP 2143)(I)(G).
The teachings of modified Sun would yield wherein the layer of powders is made from powders obtained by a freeze-drying process (modified by Yang’s teaching) for achieving a sufficient large specific surface area and sufficient high sensitivity (interpreted as an intended use. The layer of powder made meets the structural limitation of the intended use. Furthermore, Yang, para. 0058 teaches freezing drying helps with aggregation of graphene during drying, which prevent lowering of surface area, and thus higher with sensitivity).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (US 20190313944 A1) in view of Sõritski et al. (WO 2022101797 A1) as applied to claim 1, and further in view of Lee et al. (US 20120205606 A1).
Regarding claim 4, modified Sun teaches all of the elements of the current invention as stated above with respect to claim 1. With respects to the limitation “wherein the layer of powders is disposed using spray coating technique,” this limitation is a product by process claim. See MPEP 2113(I). The method of the layer of powder is disposed still provides the end product of a layer of powder.
If it is determined that the layer of powders disposed using spray coating technique, the follow obvious rejection put forth.
Sun teaches a layer powders of graphene coated with potassium ferrocyanide (para. 0007, 0142 and 0154), being screen-printed on the surface of the layer of conducting metal electrode (para. 0036), but thus fails to teach the layer of powders is disposed using spray coating technique.
However, Lee teaches depositing a thin layer of graphene on the surface of a metal electrode. Lee further teaches that can be accomplished screen printing or spraying (para. 0044, 0060).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the method of screen printing taught by Sun with spray coating taught by Lee to deposit the layer of powders because one of ordinary skill in the art would accordingly have recognized the spraying would result in the predictable result of providing a means of depositing a layer of powders on the surface of the layer of metal electrode.
Claim 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (US 20190313944 A1) in view of Sõritski et al. (WO 2022101797 A1) as applied to claim 1, and further in view of Seguro et al. (“Low Cost, Easy to Prepare and Disposable Electrochemical Molecularly Imprinted Sensor for Diclofenac Detection.” Sensors (Basel). 2021 Mar 11;21(6):1975.)
Regarding claim 5, modified Sun teaches all of the elements of the current invention as stated above with respect to claim 1. With respects to the limitation “wherein the layer of MIP is imprinted by dipping the pre-washing sensor in 70% ethanol in water from 3 seconds to 5 minutes to wash away the template virus material,” the limitation is a product by process claim. See MPEP 2113(I). Paras. 0154-0155, teaches the sensor after forming of MIP with polymerization is washed with ethanol. The examiner interprets the % of ethanol used and wash duration still provides the end product of the layer of MIP).
In addition, Seguro teaches the preparation of a MIP sensor. Segura further teaches MIP preparation conditions including extraction conditions require optimization (p. 5, section 3.3), and thus Segura teaches wherein the extraction conditions including solvent and wash/extraction time are result-effective variable. Specifically, Seguro teaches that the extraction conditions affect the performance of the sensor (p. 7, section 3.3.3). Since these particular parameters are recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modified the (extraction conditions) solvent and wash time taught by Sun to 70% ethanol in water and 3 minutes, respectively, because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Regarding claim 6, modified Sun teaches all of the elements of the current invention as stated above with respect to claim 5. Modified Sun further teaches wherein the dipping time is 3 minutes (see above).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (US 20190313944 A1) in view of Sõritski et al. (WO 2022101797 A1) as applied to claim 1, and further in view of Arumugam et al. (US 20130213823 A1).
Regarding claim 10, modified Sun teaches all of the elements of the current invention as stated above with respect to claim 1. With respects to the limitation “the biomaterial sensitized sensor of claim 1 is manufactured by using a 1 to 12-inch diameter silicon or glass wafer as the substrate layer,” this limitation is a product by process claim. See MPEP 2113(I). Para. 0062 and Fig. 13 teaches the substrate layer is made of a silicon wafer, the size of wafer does not impact the structure of the product made.
Alternately, the following obviousness rejection is put forth:
Sun teaches fabricating a electrochemical sensor (abstract) of claim 1 (see claim 1). Sun further teaches the sensor is fabricated by using a silicon wafer as the substrate layer (para. 0062), and the sensor has the size of 5 x 5 x 1 mm3 (paras. 0034 and 0168).
Sun does not explicitly teach the size of the wafer, and thus fails to teach the biomaterial sensitized sensor of claim 1 is manufactured by using a 1 to 12-inch diameter silicon or glass wafer as the substrate layer.
However, Arumugam teaches fabricating electrochemical sensors (abstract). Arumugam further teaches the sensor are manufactured by using a 4-inch diameter silicon as the substrate layer (para. 0030). Arumugam further teaches a plurality of sensors are made on a single 4 inch wafer (Figs. 1A and 1B and paras. 0030 and 0046).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the silicon wafer taught by Sun with a 4-in silicon wafer taught by Arumugam in order to manufacture multiple sensors of Sun on the wafer with a reasonable expectation of success (Arumugam, Figs. 1A and 1B and paras. 0030 and 0046)(MPEP 2143)(I)(G).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 9 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758