DETAILED ACTION
Response to Amendment
This is a final office action in response to a communication filed on September 3, 2025. Claims 1-2, 5-8, 10, 12-13, and 21-25 are pending in the application.
Status of Objections and Rejections
The rejection of claims 4 and 9 is obviated by Applicant' s cancellation.
All objections and other rejections from the previous office action are maintained.
Claim Objections
Claim(s) 22 is/are objected to because of the following informalities:
Claim 22, lines 1-2: the limitation “further comprising a plurality of SiC traces” is suggested to be deleted because it has been recited in claim 1
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 5-8, 10, 12-13, and 21-25 is/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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 7 recites the limitation “an all silicon carbide (SiC) electrode” in claim 1, line 4 and in claim 7, line 3, which is not disclosed in the specification and is deemed to be new matter. Applicant argues that the electrode made from only silicon carbide, supported by the specification that paragraphs [0015] and [0024] teach electrodes made from silicon carbide (SiC) and refer to the electrode as a “silicon carbide (SiC)” electrode. Examiner disagrees. A so-called silicon carbide (SiC) electrode does not necessarily mean the electrode is made only from silicon carbide or excludes all other materials. Applicant further argues no other material is described as being used for the electrode based on the teaching in paragraph [0039] that “in this device fabricated from SiC, SiC is used as the body of the implant, SiC is used for the electrode, and SiC is used for the electrical traces and electrical isolation.” Examiner disagrees. The teaching of SiC to be used for several components of the device, including the electrode, does not necessarily mean that the electrode is made only from silicon carbide or excludes all other materials. The absence of teachings for other materials of the electrode is distinguished from the alleged teaching that “the working electrode is an all silicon carbide (SiC) electrode” that is made of and only of SiC. Examiner notes that the specification discloses fast scan cyclic voltammetry (FSCV) electrochemical sensor comprising silicon carbide (SiC) (Specification, PG publication, [0050]), and the SiC is comprised within a SiC electrode ([0051]). This teaching suggests that the SiC electrode comprises SiC and does not exclude other materials.
Applicant argues that the alleged all SiC electrode does not include carbon fibers or metal (e.g., claims 24-25) based on teachings of paragraphs ([0005] and [0006] in the specification. Examiner disagrees. Paragraphs ([0005] and [0006] are directed to background information in the art, and the advantages and challenges of the carbon fibers and metals to be used as FSCV electrodes. Thus, there is no teachings for the alleged disclosure in the specification.
Subsequent dependent claims 2, 5-6, 21-22, and 24-25 are rejected due to their dependencies on rejected claim 1.
Subsequent dependent claims 8, 10 , 12-13, and 23 are rejected due to their dependencies on rejected claim 7.
Claims 24-25 recites the limitations “wherein the electrode does not include carbon fibers” and “wherein the electrode does not include metal” respectively, which are not disclosed in the specification and deemed to be new matter. The specification merely discloses the advantages and challenges of the carbon fibers and metals to be used as FSCV electrodes as background information in the art ([0005]-[0006]), but nowhere in the specification teaches the claimed electrode does not include carbon fibers or metal.
Claim(s) 1-2, 5-6, 21-22, and 24-25 is/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 pre-AIA the applicant regards as the invention.
Claim 1 recites “the electrolytic environment” in line 13. There is insufficient antecedent basis for this limitation in the claim. It is suggested to be “the electrochemical media.”
Subsequent dependent claims 2, 5-6, 21-22, and 24-25 are rejected due to their dependencies on rejected claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 5-7, 10, 12-13, and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ludwig (U.S. Patent Pub. 2018/0369587) in view of Bernardin (E. Bernardin, Development of an all-SiC neuronal interface device; MRS Advances, 2016(1), page 3679-84), supported by Thapar (US 5,753,938) and Muthukumar (U.S. Patent Pub. 2019/0250153) as evidence.
Regarding claim 1, Ludwig teaches a fast scan cyclic voltammetry (FSCV) electrochemical sensor (Fig. 1; [0021] lines 4-6: the sensing apparatus 104 is configured to perform fast-scan cyclic voltammetry) comprising:
an electrochemical media with free ions therein ([0023] lines 4-6: a solution, e.g., a concentration of norepinephrine or other electroactive neurochemical in whole blood of a mammal);
an all silicon carbide (SiC) electrode ([0022] lines 5-6: the sensing apparatus 104 includes a working electrode; lines 33, 37: the tip of the working electrode is made of silicon carbide; here the tip of the working electrode is deemed to be the claimed all SiC electrode) that receives an applied voltage (¶22: a signal generator that applies and varies an electrical voltage between the working electrode and reference electrode);
a SiC body containing the SiC electrode (¶22: the tip of the working electrode is made of silicon carbide; here, the tip of the working electrode is deemed to be the claimed SiC body and the SiC electrode);
a plurality of SiC traces ([0025] lines 20-23: leads from the sensing apparatus 104 may be physically connected to the signal acquisition apparatus 108 to permit the apparatus 108 to capture voltammetry signals from the sensing apparatus 104);
an interfacing surface of the SiC electrode in contact with the electrolytic environment (here, the outside surface of the SiC electrode is deemed to be the interfacing surface that must be in contact with the electrolytic environment containing analytes for measurement), and further wherein the SiC electrode acts as a biosensor in a FSCV process ([0021] lines 4-6: the sensing apparatus 104 is configured to perform fast-scan cyclic voltammetry; lines 8-11: using fast-scan cyclic voltammetry, measurements can frequently and periodically be taken of the level of a neurochemical in a volume of blood; thus the SiC electrode in the sensing apparatus 104 is deemed to act as a biosensor using FSCV process).
Alternatively, Ludwig does not explicitly disclose the SiC electrode is an all silicon carbide (SiC) electrode.
However, Bernardin teaches fabrication for producing a microelectrode array made entirely of Silicon Carbide (SiC) (page 3680, para. 2, lines 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ludwig by substituting its SiC electrode with the one entirely of SiC (i.e., an all SiC electrode) as taught by Bernardin. The suggestion for doing so would have been that SiC is a suitable material to make microelectrode array that is made entirely of SiC and the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Ludwig does not explicitly disclose the SiC electrode comprising 4H-SiC having a bandgap of 3.2eV or bond pads connected to the SiC electrode.
However, Bernardin teaches fabrication for producing a microelectrode array made entirely of Silicon Carbide (SiC) (page 3680, para. 2, lines 1-2). Bernardin teaches the fabrication flow indicating a 4H-SiC microelectrode (Fig. 2: creating a 3C-SiC all-SiC planar neural microelectrode; the process is identical for the 4H-SiC devices whereby the 3C-SiC is replaced by 4H-SiC) including a contact pad (Fig. 2(m): bottom) and recording tip (Fig. 2(m): top). From the legend of Fig. 2, the top is made of 4H-SiC (i.e., the SiC body of the SiC electrode), and the bottom is the contact pad made of Ti/Pt) connected to the SiC electrode via a SiC trace (Fig. 2(m): indicating the trace between the tip and the bottom is made of α-SiC). Thus, Bernardin teaches the bond pads connected to the SiC electrode.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ludwig by substituting its SiC electrode with the one entirely of 4H-SiC as taught by Bernardin. The suggestion for doing so would have been that 4H-SiC is a suitable material to make microelectrode array that consists of 4H-SiC only and the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07. Further, the combined Ludwig and Bernardin would be necessarily result in the bond pads being connected to the SiC electrode.
The limitation “a bandgap of 3.2eV” for 4H-SiC is inherent, as evidenced by Thapar that teaches the bandgap energy of 4H-SiC is 3.2eV (Col. 7, lines 7-8).
Ludwig and Bernardin do not disclose bond pads soldered to a connector to transmit current received by the SiC electrode from an electron exchange with a target molecule in the electrochemical media.
However, Ludwig teaches an communication interface 120 configured to receive, and optionally transmit, data to the voltammetry computing system 102 over a physical or wireless link (Fig. 1; ¶30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ludwig and Bernardin by incorporating a physical link, e.g., a connector, for transmitting current received by the SiC electrode from an electron exchange with a target molecule in the electrochemical media because the connector would enable the connection between the sensor and the computing system for data processing and analysis. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Further, the designation “to transmit current received by the SiC electrode from an electron exchange with a target molecule in the electrochemical media” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Ludwig in view of Bernardin teaches a FSCV electrochemical sensor (Ludwig, [0021] lines 4-6) including a SiC electrode (Ludwig, [0022] lines 5-6) made entirely of SiC that is 4H-SiC having a bandgap of 3.2eV (Bernardin, Fig. 2; Thapar, page 7, lines 7-8) and bond pads connected the SiC electrode (Bernardin, Fig. 2), and therefore the bond pads would be capable of being soldered to a connector to transmit current received by the SiC electrode from an electron exchange with a target molecule in an electrolytic environment. Further, the designation “soldered” is product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113(I). Here, there is no apparent difference between the claimed system and the one of the prior art as taught by Ludwig in view of Bernardin. Still further, the designation “a target molecule in the electrochemical media” is directed to a material or article worked upon. "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Young, 75 F.2d. 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)). MPEP 2115.
The designation “wherein the interacting surface exhibits a capacitive electrochemical profile of the 4H-SiC electrode in the electrolytic environment” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Ludwig in view of Bernardin teaches a FSCV electrochemical sensor (Ludwig, [0021] lines 4-6) including a SiC electrode (Ludwig, [0022] lines 5-6) made entirely of SiC that is 4H-SiC having a bandgap of 3.2eV (Bernardin, Fig. 2; Thapar, page 7, lines 7-8), bond pads connected the SiC electrode (Bernardin, Fig. 2), an interacting surface of the SiC electrode (i.e., the outside surface of the electrode in contact with the electrolytic environment), and therefore the interacting surface of the SiC electrode must be in contact with the electrolytic environment for electrochemical measurements and would naturally exhibit a capacitive electrochemical profile of the 4H-SiC electrode in the electrolytic environment during the FSCV measurement due to the interaction between the electrode and the electrochemical media containing the target molecule; in another word, the same material of the electrode undergoes the same process, must exhibit the same phenomenon, i.e., exhibiting the capacitive electrochemical profile of the 4H-SiC electrode in the electrolytic environment.
The designation “wherein an applied voltage is repeatedly swept from -2V to +2.8V, and further wherein the SiC electrode acts as a biosensor in a FSCV Process via capacitance with the electrochemical media” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Ludwig in view of Bernardin teaches a FSCV electrochemical sensor (Ludwig, [0021] lines 4-6) including a SiC electrode (Ludwig, [0022] lines 5-6) made entirely of SiC that is 4H-SiC having a bandgap of 3.2eV (Bernardin, Fig. 2; Thapar, page 7, lines 7-8), and therefore the 4H-SiC electrode would be capable of receiving an applied voltage swept in the claimed range -2V to +2.8V and acts as a biosensor in a FSCB process via capacitance with the electrochemical media.
Regarding claim 5, Ludwig teaches wherein the SiC electrode is comprised within a electrochemical-type voltammetry sensing system (Fig. 1; [0020] lines 1, 6-7: an example environment 100; lines 6-7: including a voltammetry computing system 102, sensing apparatus 104, and a bioelectric stimulus system 106; [0022] lines 5-6: the sensing apparatus 104 includes a working electrode; lines 33, 37: the tip of the working electrode is made of silicon carbide) to provide real-time detection in humans ([0003] lines 2-3, 5-7: estimating the level of a neurotransmitter in blood, e.g., norepinephrine, in whole blood of a mammal using a fast-scan cyclic voltammetry process performed in vivo, e.g., in a blood vessel; [0029] line 6, a mammal, e.g., a human; [0057] lines 16-19: FSCV is an electrochemical technique that can be used in the central nervous system to measure norepinephrine with subsecond and submillimeter precision).
Further, the designation “wherein the SiC electrode is comprised within a electrochemical-type voltammetry sensing system to provide real-time detection in humans” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Ludwig in view of Bernardin teaches a FSCV electrochemical sensor (Ludwig, [0021] lines 4-6) including a SiC electrode (Ludwig, [0022] lines 5-6) made entirely of SiC that is 4H-SiC having a bandgap of 3.2eV (Bernardin, Fig. 2; Thapar, page 7, lines 7-8), bond pads connected the SiC electrode (Bernardin, Fig. 2), an interacting surface of the SiC electrode (i.e., the outside surface of the SiC electrode), and therefore the SiC electrode would be capable of sensing and providing real-time detection in humans.
Regarding claim 6, Ludwig teaches wherein the SiC electrode is comprised within a sensing system (Fig. 1; [0020] line 1: an example environment 100) to detect molecules which experience redox reactions ([0027] lines 5-8: determines a peak electrical current in the voltammogram for an oxidation or reduction phase, or determines an area of a peak oxidation or reduction wave in the voltammogram, or both) in-vitro or in-vivo ([0003] lines 2-3, 5-7: estimating the level of a neurotransmitter in blood, e.g., norepinephrine, in whole blood of a mammal using a fast-scan cyclic voltammetry process performed in vivo, e.g., in a blood vessel).
The designation “to detect molecules which experience redox reactions in-vitro or in-vivo to diagnose or detect disease” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Ludwig in view of Bernardin teaches a FSCV electrochemical sensor (Ludwig, [0021] lines 4-6) including a SiC electrode (Ludwig, [0022] lines 5-6) made entirely of SiC that is 4H-SiC having a bandgap of 3.2eV (Bernardin, Fig. 2; Thapar, page 7, lines 7-8), bond pads connected the SiC electrode (Bernardin, Fig. 2), an interacting surface of the SiC electrode (i.e., the outside surface of the SiC electrode), and therefore the SiC electrode would be capable of detecting molecules which experience redox reactions in-vitro or in-vivo to diagnose or detect disease.
Regarding claim 7, Ludwig teaches a system (Fig. 1; [0020] lines 5-7: an environment 100 includes a voltammetry computing system 102, a sensing apparatus 104, and a bioelectric stimulus system 106) comprising:
an electrochemical media with free ions therein ([0023] lines 4-6: a solution, e.g., a concentration of norepinephrine or other electroactive neurochemical in whole blood of a mammal);
an all silicon carbide (SiC) electrode ([0022] lines 5-6: the sensing apparatus 104 includes a working electrode; lines 33, 37: the tip of the working electrode is made of silicon carbide SiC; here the tip of the working electrode is deemed to be the claimed all SiC electrode) that receives an applied voltage (¶22: a signal generator that applies and varies an electrical voltage between the working electrode and reference electrode), and an interacting surface in contact with the electrochemical media with free ions of the electrochemical media (here, the outside surface of the SiC electrode is deemed to the interacting surface of the SiC electrode and it must be in contact with the electrochemical media for FSCV measurement);
a SiC body containing the SiC electrode (¶22: the tip of the working electrode is made of silicon carbide; here, the tip of the working electrode is deemed to be the claimed SiC body and the SiC electrode);
wherein the voltage applied to the electrode ([0022] lines 18-20: the sensing apparatus 104 may include a signal generator that applies and varies an electrical voltage) and repeatedly swept within a range ([0022] lines 41-46: during fast-scan cyclic voltammetry, the signal generator repeatedly ramps up and down the applied voltage between a lower voltage level limit and an upper voltage level limit; an example waveform of voltages applied during a fast-scan cyclic voltammetry process in depicted in Fig. 2; Fig. 2: indicating the voltage is swept within a range from -0.4 V to 1.45V); and
a computing device (Fig. 1; [0020] line 6: a voltammetry computing system 102) receiving the current received by the SiC electrode ([0024] lines 2, 10: to receive signals to generate voltammetry data), wherein the computing device is configured to perform an electrochemical evaluation with the current ([0023] lines 1-4: the voltammetry computing system 102 is configured to receive signals from the sensing apparatus 104 and to process the signals to determine levels of one or more analytes in a solution; [0024] lines 10-12: voltammetry data that can be processed by the voltammogram generation and analysis engine 110), wherein the SiC electrode is configured to act as a biosensor in a fast scan cyclic voltammetry (FSCV) process ([0021] lines 4-6: the sensing apparatus 104 is configured to perform fast-scan cyclic voltammetry; lines 8-11: using fast-scan cyclic voltammetry, measurements can frequently and periodically be taken of the level of a neurochemical in a volume of blood; thus the SiC electrode in the sensing apparatus 104 is deemed to act as a biosensor using FSCV process).
As evidenced by Muthukumar, in voltammetry, current is measured by varying the potential applied to the sensing electrode (Muthukumar, [0159] lines 11-12).
Alternatively, Ludwig does not explicitly disclose the SiC electrode is an all silicon carbide (SiC) electrode.
However, Bernardin teaches fabrication for producing a microelectrode array made entirely of Silicon Carbide (SiC) (page 3680, para. 2, lines 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ludwig by substituting its SiC electrode with the one made entirely of SiC (i.e., an all SiC electrode) as taught by Bernardin. The suggestion for doing so would have been that SiC is a suitable material to make microelectrode array that consists of SiC only and the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Ludwig does not explicitly disclose the SiC electrode comprising 4H-SiC bandgap having a bandgap of 3.2eV or bond pads connected to the SiC electrode.
However, Bernardin teaches fabrication for producing a microelectrode array made entirely of Silicon Carbide (SiC) (page 3680, para. 2, lines 1-2). Bernardin teaches the fabrication flow indicating a 4H-SiC microelectrode (Fig. 2: creating a 3C-SiC all-SiC planar neural microelectrode; the process is identical for the 4H-SiC devices whereby the 3C-SiC is replaced by 4H-SiC) including a contact pad (Fig. 2(m): bottom) and recording tip (Fig. 2(m): top). From the legend of Fig. 2, the top is made of 4H-SiC (i.e., the SiC body of the SiC electrode), and the bottom is the contact pad made of Ti/Pt) connected to the SiC electrode via a SiC trace (Fig. 2(m): indicating the trace between the tip and the bottom is made of α-SiC). Thus, Bernardin teaches the bond pads connected to the SiC electrode.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ludwig by substituting its SiC electrode with the one entirely of 4H-SiC as taught by Bernardin. The suggestion for doing so would have been that 4H-SiC is a suitable material to make microelectrode array that consists of 4H-SiC only and the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07. Further, the combined Ludwig and Bernardin would be necessarily result in the bond pads being connected to the SiC electrode.
The limitation “bandgap of 3.2eV” for 4H-SiC is inherent, as evidenced by Thapar that teaches the bandgap energy of 4H-SiC is 3.2eV (page 7, lines 7-8).
The designations “that receives an applied voltage,” “wherein the applied voltage is repeatedly swept within the range from -2V to +2.8V to induce reactions in the electrochemical media and cause the SiC electrode to receive an electron exchange with the target molecule in the electrochemical media,” and “wherein the SiC electrode is configured to act as a biosensor in a fast scan cyclic voltammetry (FSCV) process” are deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Ludwig in view of Bernardin teaches a FSCV electrochemical sensor (Ludwig, [0021] lines 4-6) including a SiC electrode (Ludwig, [0022] lines 5-6) made entirely of SiC that is 4H-SiC having a bandgap of 3.2eV (Bernardin, Fig. 2; Thapar, page 7, lines 7-8), bond pads connected the SiC electrode (Bernardin, Fig. 2), and therefore the SiC electrode is capable of being applied with a voltage repeatedly swept within a range from -2V to +2.8V and naturally inducing reactions in the electrochemical media and causing the SiC electrode to receive an electron exchange with the target molecule in the electrochemical media so that the SiC electrode would be able to act as a biosensor in a fast scan cyclic voltammetry (FSCV) process.
The designation “exhibiting a capacitive electrochemical profile in contact with free ions of the electrochemical media” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Ludwig in view of Bernardin teaches a system (Ludwig, Fig. 1; [0020] lines 5-7) including an electrochemical media ([0023] lines 4-6), a SiC electrode (Ludwig, [0022] lines 5-6) made entirely of SiC that is 4H-SiC having a bandgap of 3.2eV (Bernardin, Fig. 2; Thapar, page 7, lines 7-8) comprising an interacting surface (i.e., the outside surface of the SiC electrode) in contact with the electrochemical media (Ludwig, [0023] lines 4-6), bond pads connected the SiC electrode (Bernardin, Fig. 2), and therefore the interacting surface would naturally exhibit a capacitive electrochemical profile in contact with free ions of the electrochemical media during the FSCV measurement due to the interaction between the electrode and the electrochemical media containing the target molecule; in another word, the same material of the electrode undergoes the same process, must exhibit the same phenomenon, i.e., exhibiting the capacitive electrochemical profile on the interacting surface.
The designation “configured to be soldered to a connector to transmit current received by the SiC electrode from an electron exchange with a target molecule in the electrochemical media” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Ludwig in view of Bernardin teaches a FSCV electrochemical sensor (Ludwig, [0021] lines 4-6) including a SiC electrode (Ludwig, [0022] lines 5-6) made entirely of SiC that is 4H-SiC having a bandgap of 3.2eV (Bernardin, Fig. 2; Thapar, page 7, lines 7-8) and bond pads connected the SiC electrode (Bernardin, Fig. 2), and therefore the bond pads would be capable of being soldered to a connector to transmit current received by the SiC electrode from an electron exchange with a target molecule in an electrolytic environment. Further, the designation “to be soldered” is product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113(I). Here, there is no apparent difference between the claimed system and the one of the prior art as taught by Ludwig in view of Bernardin. Still further, the designation “a target molecule in the electrochemical media” is directed to a material or article worked upon. "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Young, 75 F.2d. 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)). MPEP 2115.
Regarding claim 10, Ludwig teaches wherein the voltage is applied to the SiC electrode as the SiC electrode passes within a distance of a physiological species ([0005] lines 2-5: inserting a sensing apparatus in a blood vessel of a mammal; performing a fast-scan cyclic voltammetry process using the sensing apparatus in the blood vessel of the mammal; lines 7-9: processing the cyclic voltammogram to determine a concentration of a neurochemical in blood transported within the blood vessel; thus the applied voltage between the working electrode and the reference electrode of the sensing apparatus must pass within a distance of the analyte to be detected in the blood, e.g., a neurochemical in blood, transported within the blood vessel).
Further, the designation “wherein the voltage is applied to the SiC electrode as the SiC electrode passes within a distance of a physiological species” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Ludwig in view of Bernardin teaches a FSCV electrochemical sensor (Ludwig, [0021] lines 4-6) including a SiC electrode (Ludwig, [0022] lines 5-6) made entirely of SiC that is 4H-SiC having a bandgap of 3.2eV (Bernardin, Fig. 2; Thapar, page 7, lines 7-8), bond pads connected the SiC electrode (Bernardin, Fig. 2), a voltage applied to the electrode being repeatedly swept (Ludwig, Fig. 2; [0022] lines 18-20), a computing device (Fig. 1; [0020] line 6), and therefore the SiC electrode would be capable of passing within a distance of a physiological species while being applied with the voltage.
Regarding claim 12, Ludwig teaches wherein the computing device is configured to use an output in a biomedical application ([0028] lines 1-7: the voltammetry computing system 102 can also include a neurochemical concentration model 112 that models relationships between the voltammogram features and levels of analytes in solution, e.g., concentration of norepinephrine or other neurochemicals in whole blood of a mammal; thus the voltammetry computing system 102 is configured to use the output in a biomedical application).
Further, the designation “configured to use an output in a biomedical application” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Ludwig in view of Bernardin teaches a FSCV electrochemical sensor (Ludwig, [0021] lines 4-6) including a SiC electrode (Ludwig, [0022] lines 5-6) made entirely of SiC that is 4H-SiC having a bandgap of 3.2eV (Bernardin, Fig. 2; Thapar, page 7, lines 7-8), bond pads connected the SiC electrode (Bernardin, Fig. 2), a voltage applied to the electrode being repeatedly swept (Ludwig, Fig. 2; [0022] lines 18-20), a computing device (Fig. 1; [0020] line 6), and therefore the computing device would be capable of using an output in a biomedical application.
Regarding claim 13, Ludwig teaches wherein the biomedical application is detecting species ([0028] lines 5-6: norepinephrine or other neurochemicals) which can be oxidized or reduced in the electrochemical media with free ions therein ([0027] lines 1-4: the VGA engine 110 is configured to determine features of a voltammogram to estimate a level of neurochemical in whole blood or other solutions; lines 5-6: determines a peak electrical current in the voltammogram for an oxidation of reduction phase; thus, the analyte to be detected, e.g., the neurochemical, can be oxidized or reduced in an electrochemical media).
Regarding claims 22-23, Ludwig and Bernardin disclose all limitations of claims 1 and 7 as applied to claims 1 and 7, respectively, and the FSCV electrochemical sensor further comprising a plurality of SiC traces (Ludwig, [0025] lines 20-23). Ludwig does not explicitly disclose wherein the bond pads are connected to the SiC electrode via the plurality of SiC traces.
However, Bernardin teaches a fabrication flow, indicating a 4H-SiC microelectrode (Fig. 2: creating a 3C-SiC all-SiC planar neural microelectrode) including a contact pad (Fig. 2(m): bottom) and recording tip (Fig. 2(m): top). From the legend of Fig. 2, the top is made of 4H-SiC (i.e., the SiC body of the SiC electrode), and the bottom is the contact pad made of Ti/Pt) connected to the SiC electrode via a SiC trace (Fig. 2(m): indicating the trace between the tip and the bottom is made of α-SiC). Since each single electrode has its own trace connected to a contact pad, the microelectrode array would have a plurality of SiC traces connected to bond pads.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ludwig by connecting the bond pads to the SiC electrode via the plurality of SiC traces because it provides a suitable configuration of electrode, traces, and bond pads. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Regarding claims 24-25, Ludwig teaches the tip of the working electrode of Ludwig is made of silicon carbide (Ludwig, ¶22), and Bernardin teaches the microelectrode array made entirely of SiC (Bernardin, page 3680, para. 2, lines 1-2).
Claim(s) 2 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ludwig in view of Bernardin, and further in view of Riehl (U.S. Patent Pub. 2010/0252450).
Regarding claims 2 and 8, Ludwig and Bernardin disclose all limitations of claims 1 and 7 as applied to claims 1 and 7, respectively. Ludwig and Bernardin do not explicitly disclose the SiC is single crystal SiC.
However, Riehl teaches an active electrode structure provided that includes fullerenes produced by conversion form a carbide or including a fullerene covalently bonded to a carbide ([0011] lines 2-5). The substrate for the electrode may be any carbide ceramic, such as silicon carbide in single crystal, polycrystalline or amorphous states ([0053] lines 1-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ludwig and Bernardin by substituting the 4H-SiC electrode with the one with the single crystal SiC as taught by Riehl. The suggestion for doing so would have been that the single crystal SiC is a suitable material for being comprised in an electrode for cyclic voltammetry measurements and the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ludwig and Bernardin, and further in view of Bennet (U.S. Patent Pub. 2018/0092575).
Regarding claim 21, Ludwig and Bernardin disclose all limitations of claim 1 as applied to claim 1. Ludwig and Bernardin do not explicitly disclose wherein the silicon carbide (SiC) electrode has an area between 0.46K square microns and 500K square microns, inclusive.
However, Bennet teaches assessing concentrations of analyte in an environment using a diamond-containing carbon electrode using FSCV ([Abstract] lines 1-4). The diameter of the conical electrode tips was approximately 50 µm, and the exposed length around 100 µm for a total (geometric) surface area of approximately 10,000 µm2, which lies within the claimed electrode area range between 0.46K square microns and 500K square microns, inclusive.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ludwig and Bernardin by adjusting the electrode area within the claimed range as suggested by Bennet because such an electrode area is a suitable carbon electrode area for FSCV measurement. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues that the recited “an all silicon carbide (SiC) electrode” (i.e., an electrode made of SiC only) has support in the specification (pp. 5-6). Examiner reconsiders but maintains the 112(a) rejection because the specification does not explicitly disclose or suggest that the SiC electrode only contains SiC, as described supra.
Applicant argues the electrode of Ludwig is not “all silicon carbide” because it discloses the electrode is made from “carbon fiber” with a silicon carbide tip (p. 7; citing Ludwig, ¶22). Examiner disagrees. Ludwig teaches in some implementation a tip of the working electrode is made of carbon fiber (¶22, ll. 25-26), and in some implementation the tip of the working electrode is made of silicon carbide (¶22, ll. 32-37). Thus, the tip of Ludwig’s electrode is deemed to be the recited electrode, and it can be made of either carbon fiber or silicon carbide, but not necessarily both.
Applicant argues there is no motivation to combine Bernardin with Ludwig because Bernadin teaches an intracortical neural interface that provides “a direct communication between the brain and external computerized devices (p. 7, para. 3, citing Bernadin Abstract and Introduction), while Ludwig teaches a FSCV sensing apparatus that determines a concentration of a neurochemical in the volume of blood of a mammal (p. 7, para. 4, citing Ludwig ¶¶4-5). Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, both Ludwig and Bernadin are related to using an electrode with electrochemical interaction, and it would be obvious to one of ordinary skill in the art to refer to Bernadin and use the material of its electrode for the same pertinent issue.
Applicant argues Ludwig’s teaching of using silicon carbide in just the tip of the electrode (rather than the entire electrode) teaches away from the use of an all-silicon carbide electrode (p. 7, last para.). Examiner disagrees because Ludwig does not criticize, discredit, or otherwise discourage the solution claimed (instead, the tip of the electrode is deemed to be the claimed electrode which is the part functioning as a working electrode), the reference does not teach away from the combination.
Interview with the Examiner
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Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/C. SUN/Primary Examiner, Art Unit 1795