DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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)(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, 3-5, 9, 10, 12-14, 17, 20, 22, 27-30 and 41 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sun et al (US PGPub 2023/0296597), cited on the IDS.
The applied reference has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding Claim 1, Sun et al teaches a sensor 100 (see abstract , Figure 1 and [0028]), comprising: a doped silicon layer (referred to as a silicon substrate) (See [0061] and [0087]);
a graphene layer (referred to as electrocatalytic layer 106) on the doped silicon layer (see [0028], [0034] and [0050]) ;
a molecularly imprinted polymer (MIP) layer (referred to as polymer layer 104 derived from a MIP monomer and functional monomer on the graphene layer (see [0028]-[0031], [0048]-[0050], [0063] and Figure 1); and electrodes (102) in operative arrangement with the MIP layer and configured to provide a signal indicative of a resistance (see [0028], [0062] and Figure 1).
Regarding Claim 3, Sun et al teaches that the graphene layer comprises graphene and potassium ferrocyanide (see [0034], [0050] and [0055]).
Regarding Claim 4, Sun et al teaches that the MIP monomer is pyrrole (see [0048]-[0049]).
Regarding Claim 5, Sun et al teaches that the functional monomer is methacrylic acid (see [0049]).
Regarding Claim 9, Sun et al teaches that the MIP layer is selective for one or more analytes (see [0048]).
Regarding Claim 10, Sun et al teaches that the one or more analytes is in gas or aerosol form (see [0066] and [0100]).
Regarding Claim 12, Sun et al teaches that the one or more analytes is a receptor-binding domain of a virus (see [0009] and [0047]).
Regarding Claims 13-14, Sun et al teaches that the one or more analytes is a glycoprotein, specifically a glycosylated spike protein (see [0009], [0035] and [0047]).
Regarding Claim 17, Sun et al teaches that the virus is SARS-CoV-2 (see [0009], [0035] and [0047]).
Regarding Claim 20, Sun et al teaches that the one or more analytes is SARS-CoV-2 (see [0009] and [0047]).
Regarding Claim 22, Sun et al teaches that the one or more analytes is associated with COVID-19 (see [0103]-[0104]).
Regarding Claim 27, Sun et al teaches a detector (200) (see Figure 7, [0011] and [0029]) comprising: a sensor of claim 1 (see abstract and [0028]); and a voltage source (referred to as a voltage source 210) (see [0011], [0029] and [0065] and Figure 7).
Regarding Claim 28, Sun et al teaches that the detector (200) further comprises an ohmmeter (212) in operative arrangement with the electrodes and configured to output a measurement of the resistance (see [0029] and [0065]).
Regarding Claim 29, Sun et al teaches a method of detecting an analyte in a sample, comprising: measuring the resistance of a sensor of claim 1 (as described above) that is in contact with the sample to obtain a measured resistance, wherein: the sensor is selective for the analyte; and the measured resistance is indicative of presence or absence of the analyte in the sample (see [0012], [0014], [0045] and [0080]).
Regarding Claim 30, Sun et al teaches a method of detecting a viral infection in a subject, comprising: measuring the resistance of a sensor of claim 1 that is in contact with a sample from a subject to obtain a measured resistance, wherein: the sensor is selective for an analyte associated with the viral infection; and the measured resistance is indicative of presence or absence of the viral infection in the subject (see [0013] and claim 25).
Regarding Claim 41, Sun et al teaches a method of fabricating a sensor, comprising: forming a graphene layer on a doped silicon layer; and forming a MIP layer derived from a MIP monomer and functional monomer on the graphene layer (see [0087] and claim 26).
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(s) 1, 3-6, 8-10, 12, 13, 17, 20, 22, 27-30 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Sun (US PGPub 2019/0313944, cited on the IDS), hereinafter referred to as Sun ‘944, in view of Kendall et al (US PGPub 2022/0346679).
Regarding Claim 1, Sun ‘944 teaches a sensor (see abstract , Figures 1 and 13a, [0141] and and [0166]), comprising: a silicon layer (illustrated in Figures 1 and 13a ) (see abstract, [0007], [0071] and [0115]);
a graphene layer on the silicon layer (see [0007], [0071] and Figure 1);
a molecularly imprinted polymer (MIP) layer derived from a MIP monomer and functional monomer on the graphene layer (see abstract, [0078] and [0141]); and electrodes in operative arrangement with the MIP layer and configured to provide a signal indicative of a resistance (see Figures 1, 13, [0147] and [0166]).
Sun ‘944 does not explicitly disclose that the silicon layer is a doped silicon layer.
However, in the analogous art of analyte measurement systems, Kendall teaches a sensor comprising a molecularly imprinted polymer (see [0605] and abstract), a silicon layer (substrate) (see [0293]), and electrodes (see [0067], [0112] and [0114]). In addition, Kendall et al teaches the use of graphene as an insulating material (see [0292]). In addition, Kendall et al teaches that the substrate may be doped (see [0291]-[0292], so as to provide required conductivity (see [0292] and [0344]). It would have been obvious to one of ordinary skill in the art to have the silicon layer be a doped silicon layer for the benefit of providing the required and increased conductivity.
Regarding Claim 3, Sun ‘944 teaches teaches that the graphene layer comprises graphene and potassium ferrocyanide (see [0075] and [0117]).
Regarding Claim 4, Sun ‘944 teaches that the MIP monomer is pyrrole (see [0007] and [0077]).
Regarding Claim 5, Sun ‘944 teaches that the functional monomer is methacrylic acid (see [0077]).
Regarding Claim 6, Sun ‘944 teaches that the MIP layer is further derived from a cross-linking monomer (see [0145]).
Regarding Claim 8, Sun ‘944 teaches a sensor (see abstract , Figures 1 and 13a, [0141] and [0166]), comprising: a silicon layer (illustrated in Figures 1 and 13a ) (see abstract, [0007], [0071] and [0115]);
a graphene layer on the silicon layer (see [0007], [0071] and Figure 1);
a molecularly imprinted polymer (MIP) layer derived from a MIP monomer and functional monomer on the graphene layer (see abstract, [0078] and [0141]); and electrodes in operative arrangement with the MIP layer and configured to provide a signal indicative of a resistance (see Figures 1, 13, [0147] and [0166]).
Furthermore, Sun ‘944 teaches that the MIP layer is selective for a set or subset of analytes associated with a particular disease or disorder (see [0080] and that the MIP layer comprises polypyrrole (see [0117]) and that a thin layer of molecularly imprinted polymer is formed through the cyclic voltammetry. The electrochemical polymerization procedure starts with mixing pyrrole with the template molecules (e.g., biomarker VOCs) in aqueous solution of phosphate buffer solution (see [0173]).
Sun ‘944 does not explicitly disclose that the silicon layer is a doped silicon layer with an etched surface or that the MIP layer is of poly(pyrrole-co-EGDMA-co-methacrylic acid) or poly(pyrrole-co- dopamine).
However, in the analogous art of analyte measurement systems, Kendall teaches a sensor comprising a molecularly imprinted polymer (see [0605] and abstract), a silicon layer (substrate) (see [0293]), and electrodes (see [0067], [0112] and [0114]). In addition, Kendall et al teaches the use of graphene as an insulating material (see [0292]). In addition, Kendall et al teaches that the substrate may be doped (see [0291]-[0292], so as to provide required conductivity (see [0292] and [0344]). Furthermore, Kendall et al teaches that the silicon layer is etched (see [0293]), wherein through selective etching electrical connections are produced (see [0593]).In addition, Kendall et al teaches that the MIP layer is formed from one or more monomers selected from the group consisting of aminothiophenol, methacrylic acid, vinyl pyridine, acrylamide, aminophenol, 1,2-dimethylimidazole, dimetridazole, o-phenylenediamine, 4-amino-5-hydroxy-2,7-naphthalenedisulfonic acid, pyrrole, aminobenzenethiol-co-p-aminobenzoic acid, vinylpyrrolidone, vinylferrocene, bis(2,2′-bithien-5-yl)methane, pyridine, chitosan, 3,4-ethylenedioxythiophene, 1-mercapto-1-undecanol, dopamine, methylmethacrylate, dimethylmethacrylate, carboxylated pyrrole, aniline, thiophene acetic acid and thiophene (see [0019]) and that the molecularly imprinted polymer is non-conductive polypyrrole or non-conductive polypyrrole-3-carboxylic acid (see [0024]-[0025] and [0334]-[0335]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have the silicon layer be a doped silicon layer that is etched for the benefit of providing the required and increased conductivity, while also enabling electrical connections to be produced (through the etching). Furthermore, it would have been obvious to one of ordinary skill in the art to have the MIP layer be poly(pyrrole-co- dopamine) (as taught by Kendall et al) for the benefit of ensuring that the MIP is non-conductive and insulating.
Regarding Claim 9, Sun ‘944 teaches that the MIP layer is selective for one or more analytes (see [0036], [0076] and [0330]).
Regarding Claim 10, Sun ‘944 teaches that the one or more analytes is in gas form (see [0081] and [0138]).
Regarding Claim 12, Sun ‘944 does not teach that the one or more analytes is a receptor-binding domain of a virus.
However, in the analogous art of analyte measurement systems, Kendall teaches a sensor comprising a molecularly imprinted polymer (see [0605] and abstract), a silicon layer (substrate) (see [0293]), and electrodes (see [0067], [0112] and [0114]), wherein the analytes used in this sensor are the receptor-binding domains of a virus (see [0040], [0076] and [0350]). It would have been obvious to utilize receptor-binding domains of a virus as the analyte (as taught by Kendall et al) for the benefit of enabling the analyte to function as a marker of a condition, disease, disorder or a normal or pathologic process that occurs in a subject, or a compound which can be used to monitor levels of an administered substance in the subject, such as a medicament (e.g., drug, vaccine), an illicit substance (e.g. illicit drug), a non-illicit substance of abuse (e.g. alcohol or prescription drug taken for non-medical reasons), a poison or toxin, a chemical warfare agent (e.g. nerve agent, and the like) or a metabolite thereof.
Regarding Claim 13, the combination of Sun ‘944 and Kendall et al teaches that the one or more analytes is a glycoprotein (see Table 1 of Kendall et al).
Regarding Claims 17 and 20, the combination of Sun ‘944 and Kendall et al teaches that the virus is SARS-CoV-2, and that the MIP layer is selective towards SARS-CoV-2 (see [0678] of Kendall et al).
Regarding Claim 27, Sun ‘944 teaches a detector (i.e. a detection device, as illustrated in Figures 1 and 13)(see abstract and [0118]), comprising:
a sensor of claim 1 (see above claim 1 rejection using Sun ‘944 and Kendall et al); and a voltage source (such as Potentiostat model Solartron SI 1287) configured to apply voltage to the MIP layer (see [0078], [0150] and Figure 1).
Regarding Claim 28, Sun ‘944 teaches an ohmmeter in operative arrangement with the electrodes and configured to output a measurement of the resistance (see [0008] and [0018]).
Regarding Claim 29, Sun ‘944 teaches a method of detecting an analyte in a sample, comprising: measuring the resistance of a sensor of claim 1 (as described above using Sun ‘944 and Kendall et al) that is in contact with the sample to obtain a measured resistance (see [0009]-[0010] and [0138]), wherein: the sensor is selective for the analyte; and the measured resistance is indicative of presence or absence of the analyte in the sample (see [0009]-[0010] and [0138]).
Regarding Claim 30, Sun ‘944 teaches a method of diagnosing a disease or condition in a subject, comprising: measuring the resistance of a sensor of claim 1 (see above claim 1 rejection using Sun ‘944 and Kendall et al) that is in contact with a sample from a subject to obtain a measured resistance (see [0011]), wherein: the sensor is selective for an analyte associated with the disease or condition; and the measured resistance is indicative of whether the subject has the disease or condition (see [0011]).
Sun ‘944 does not explicitly disclose that the disease or condition detected/diagnosed is a viral infection.
However, in the analogous art of analyte measurement systems, Kendall teaches a sensor comprising a molecularly imprinted polymer (see [0605] and abstract), a silicon layer (substrate) (see [0293]), and electrodes (see [0067], [0112] and [0114]), wherein the analytes used in this sensor are the receptor-binding domains of a virus (see [0040], [0076] and [0350]) and are used to diagnose/detect viral infections. It would have been obvious to one of ordinary skill in the art to modify the method of Sun ‘944 by utilizing a virus receptor as the analyte (as taught by Kendall et al) for the benefit of enabling various viral infections to also be diagnosed/detected via the sensor.
Regarding Claim 41, Sun ‘944 teaches a method of fabricating a sensor (see [0138], [0141] and [0173]), comprising: forming a graphene layer on a silicon layer (see [0173]; and forming a MIP layer derived from a MIP monomer and functional monomer on the graphene layer ( see [0173]).
Sun ‘944 does not explicitly disclose that the silicon layer is a doped silicon layer.
However, in the analogous art of analyte measurement systems, Kendall teaches a sensor comprising a molecularly imprinted polymer (see [0605] and abstract), a silicon layer (substrate) (see [0293]), and electrodes (see [0067], [0112] and [0114]). In addition, Kendall et al teaches the use of graphene as an insulating material (see [0292]). In addition, Kendall et al teaches that the substrate may be doped (see [0291]-[0292], so as to provide required conductivity (see [0292] and [0344]). It would have been obvious to one of ordinary skill in the art to have the silicon layer be a doped silicon layer for the benefit of providing the required and increased conductivity.
Claim(s) 7, 14 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Sun ‘944 and Kendall et al as applied to claims 1, 9 and 13 above, and further in view of Gluckman et al (WO 2021/195626).
Regarding Claims 7, Sun ‘944 teaches that the MIP layer is further derived from a cross-linking monomer (see [0145]).
However, the combination of Sun ‘944 and Kendall et al does not teach that the cross-linking monomer is ethylene glycol dimethacrylate (EGDMA).
However, in the analogous art of use of molecularly imprinted polymers, Gluckman et al teaches that prior to polymerization with one or more uncharged monomers and one or more cross-linking monomers to form the MIP (e.g., MIP bead, or MIP thin film), the binding monomer is mixed with the surrogate virus (or in some embodiments, target virus), which allows the ligand monomer to “self-assemble” or coordinate to the surrogate virus (or target virus) such that during polymerization the surrogate virus (or target virus) is incorporated into the polymerized MIP (e.g. MIP bead, or MIP thin film) (see [0074]). In addition, Gluckman et al teaches that the cross-linking agent used may be EGDMA (see [0121]-[0123]). It would have been obvious to one of ordinary skill in the art to utilize EGDMA as the cross-linking agent (as taught by Gluckman et al) for the benefit of enabling ligand monomers to self-assemble or coordinate to the target virus, while imparting rigidity and structural integrity to the MIP layer.
Regarding Claim 14, the combination of Sun ‘944 and Kendall et al does not explicitly disclose that the glycoprotein is a glycosylated spike protein. However, in the analogous art of use of molecularly imprinted polymers, Gluckman et al teaches sensors coated with a MIP or MIP array of the present disclosure for detecting a target virus (such as COVID-19), wherein COVID-19 is caused by infection with the novel coronavirus, SARS-CoV-2. The SARS-CoV-2 is a spherical enveloped virus with densely glycosylated spike (S) protein used to gain entry into host cells. The spike protein is integral to the infection pathway. The spike protein binds to the cell receptor, angiotensin-converting enzyme 2 (ACE2), by means of the receptor-binding domain (RBD) and undergoes a conformational change to enter the cell (see [0008] and [0066]).
It would have been obvious to one of ordinary skill in the art to utilize a glycosylated spike protein (such as found in SARS-CoV-2, as taught by Gluckman et al) as the analyte for the benefit of enabling COVID-19 disease to be detected using the sensor.
Regarding Claim 22, the combination of Sun ‘944 and Kendall et al does not explicitly disclose that the one or more analytes are associated with COVID-19. However, in the analogous art of use of molecularly imprinted polymers, Gluckman et al teaches sensors coated with a MIP or MIP array of the present disclosure for detecting a target virus (such as COVID-19), wherein COVID-19 is caused by infection with the novel coronavirus, SARS-CoV-2. The SARS-CoV-2 is a spherical enveloped virus with densely glycosylated spike (S) protein used to gain entry into host cells. The spike protein is integral to the infection pathway. The spike protein binds to the cell receptor, angiotensin-converting enzyme 2 (ACE2), by means of the receptor-binding domain (RBD) and undergoes a conformational change to enter the cell (see [0008] and [0066]).
It would have been obvious to one of ordinary skill in the art to utilize a glycosylated spike protein (such as found in SARS-CoV-2, as taught by Gluckman et al) as the analyte for the benefit of enabling the risk of a patient or subject having or developing COVID-19 disease (a widely known viral outbreak) to be detected using the sensor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
AGNIHOTRA et al (US PGPub 2020/0200694) discloses a device for the detection of a food allergen includes a sensor having a printed circuit board and a chip comprising a molecularly imprinted polymer (MIP) and a non-imprinted polymer (NIP); a reservoir comprising a liquid; and a chamber for mixing the liquid with a food (see abstract). Furthermore, Agnihotra et al teaches that its sensor further includes a graphene layer (see [0052]) and electrodes (see [0088]).
Piletsky et al (US PGPub 2021/0010968) discloses a method of detecting an analyte in a sample. The method comprises disposing a binding agent in in an electrochemical compartment. The binding agent is configured to bind to an interfering species. The method further comprises disposing a solution comprising a sample in the electrochemical compartment. The sample comprises an analyte and the interfering species. The method then comprises applying a voltage across first and second spaced apart electrodes disposed in the solution, and thereby causing a current to flow through the solution between the electrodes. Finally, the method comprises measuring the current and/or voltage and thereby detecting the analyte (see abstract). Furthermore, it is noted that the binding agent may comprise a molecularly imprinted polymer (MIP), an antibody or a fragment thereof, an aptamer, an affimer, a lectin, a peptide, a protein, a macrocyclic ligand or an organic molecule (see [0015]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER WECKER/ Primary Examiner, Art Unit 1797