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 without traverse of Group II, claims 19-21 and 52-54, drawn to a biosensor system for characterizing an immune response to pathogen exposure and characterizing a pathogen's antigen profile in the reply filed on October 29, 2025 is acknowledged.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 19, 21, 52, and 54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shachar (US 2016/0238553).
Regarding claim 19, Shachar teaches a biosensor system (¶2: solid-state biosensors) for characterizing a subject's immune response to pathogen exposure (this preamble limitation is deemed to be a statement with regard to the intended use and are not further limiting in so far as the structure of the product is concerned. In article claims, a claimed intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP § 2111.02(II)), the system comprising:
an electronic reader (Fig. 9; ¶131: circuit architecture, called the pathfinder reader) comprising:
a circuit for delivering a signal (Fig. 9; ¶131: analog interface 802); and
a processing device for reading the signal (Fig. 9; ¶131: digital processing unit 804);
a biosensor of claim 1 (Fig. 8; ¶131: cell 1 (cells 206 or 207); Fig. 4; ¶117: bioFET cell 1) comprising:
a substrate (Fig. 4; ¶117: nonconductive substrate (SiO2) 24) comprising a planar surface (Fig. 4: the top surface of substrate 24);
a spatially defined array (Fig. 7; ¶124: array 261) of active areas on the planar surface of the substrate (Fig. 4: the top surface of the substrate 24), each active area comprising:
a carbon material (Fig. 1B, 4; ¶114: the carbon nanotubes 14); and
at least two spaced electrodes (Fig. 4; ¶117: the source 22 and the drain 23), wherein the carbon material is deposited on the planar surface of the substrate between the at least two electrodes (Fig. 4);
a plurality of pathogen proteins or peptides thereof (Fig. 3, 4; ¶116: antibody 20), wherein different pathogen proteins or peptides thereof are positioned at different active areas and immobilized on the deposited carbon material of said active areas (Fig. 3; ¶119: the CNT based semiconducting channel 14 is modified and functionalized with antibodies 20; ¶55: an array of different, selected biological reagents attached to different, selected regions on an assay); and
an electrical connection comprising a plurality of electrical contacts (Fig. 6; ¶123: electrode pad 251), each electrical contact configured to transmit an electrical signal between the at least two electrodes of a single active area and the electrical connection (¶123: acts as the electrical connection to the array of single bioFET sensor cells 252; further, this limitation is functional limitation in apparatus claims and does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. MPEP 2114 (II)) operatively connected to the electronic reader via the electrical connection of the biosensor (¶131: the array and the circuit architecture in Fig. 9 are combined) and configured to receive the signal delivered by the circuit (Fig. 9; ¶131: analog interface 802);
wherein the electronic reader is configured to deliver the signal to the biosensor and obtain an output impedance value (Fig. 5; ¶130: the measure of impedance per unit of surface area) before and after a sample has been applied to the array of active areas on the biosensor (Fig. 5; ¶121: the binding event will cause a change in the impedance; further, this limitation is functional limitation in apparatus claims and does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. MPEP 2114 (II)), and
said processing device is configured to compare the output impedance values to determine whether a binding event has occurred at one or more of the active areas to characterize the subject's immune response to pathogen exposure (this limitation is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
Regarding claim 21, Shachar teaches the biosensor system of claim 19 further comprising:
a communication interface (Fig. 9: SPI; ¶131: computer 806 including conventional input/output peripherals for data processing and display) coupled to the electronic reader for transmitting data from the electronic reader (Fig. 9: connected to the analog interface 802 and digital processing unit 804);
a data management computing device (Fig. 9; ¶131: computer 806) configured to receive data from the electronic reader via the communication interface (this limitation is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), said data management computing device comprising a memory (¶187: associated memory bank) coupled to a processor (Fig. 9: microcontroller) which is configured to execute programmed instructions comprising and stored in the memory (¶157: microcontroller 901 interfaced with a digital signal processing board and software; ¶165: the embedded software is designed to function as a state machine to control the impedance measurement sequence) to:
geographically map immune response data to pathogen exposure, based on data received from electronic reader (¶165: to control the impedance measurement sequence of impedance converter 902 over output 714, and to further provide control of DDS 903 over output 912; further, this limitation is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
Regarding claim 52, Shachar teaches a biosensor system (¶2: solid-state biosensors) for characterizing a pathogen's antigen profile (this preamble limitation is deemed to be a statement with regard to the intended use and are not further limiting in so far as the structure of the product is concerned. In article claims, a claimed intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP § 2111.02(II)), the system comprising:
an electronic reader (Fig. 9; ¶131: circuit architecture, called the pathfinder reader) comprising:
a circuit for delivering a signal (Fig. 9; ¶131: analog interface 802) and
a processing device for reading the signal (Fig. 9; ¶131: digital processing unit 804);
a biosensor of claim 31 (Fig. 8; ¶131: cell 1 (cells 206 or 207); Fig. 4; ¶117: bioFET cell 1) comprising:
a substrate (Fig. 4; ¶117: nonconductive substrate (SiO2) 24) comprising a planar surface (Fig. 4: the top surface of substrate 24);
a spatially defined array (Fig. 7; ¶124: array 261) of active areas on the planar surface of the substrate (Fig. 4: the top surface of the substrate 24); each active area comprising:
a carbon material (Fig. 1B, 4; ¶114: the carbon nanotubes 14); and
at least two spaced electrodes (Fig. 4; ¶117: the source 22 and the drain 23), wherein the carbon material is deposited on the planar surface of the substrate between the at least two electrodes (Fig. 4);
a collection of binding molecules (Fig. 3, 4; ¶116: antibody 20), wherein different binding molecules of the collection bind different pathogen proteins and wherein different binding molecules are positioned at different active areas and immobilized on the deposited carbon material of said active areas (Fig. 3; ¶119: the CNT based semiconducting channel 14 is modified and functionalized with antibodies 20; ¶55: an array of different, selected biological reagents attached to different, selected regions on an assay); and
an electrical connection comprising a plurality of electrical contacts (Fig. 6; ¶123: electrode pad 251), each electrical contact configured to transmit an electrical signal between the two or more electrodes of a single active area and the electrical connection (¶123: acts as the electrical connection to the array of single bioFET sensor cells 252; further, this limitation is functional limitation in apparatus claims and does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. MPEP 2114 (II)) operatively connected to the electronic reader via the electrical connection of the biosensor (¶131: the array and the circuit architecture in Fig. 9 are combined) and configured to receive the signal delivered by the circuit (Fig. 9; ¶131: analog interface 802);
wherein the electronic reader is configured to deliver the signal to the biosensor and obtain an output impedance value (Fig. 5; ¶130: the measure of impedance per unit of surface area) before and after a sample has been applied to the array of active areas of the biosensor (Fig. 5; ¶121: the binding event will cause a change in the impedance; further, this limitation is functional limitation in apparatus claims and does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. MPEP 2114 (II)), and
said processing device is configured to compare the output impedance values to determine whether a binding event has occurred at one or more of the active areas to characterize the pathogen's antigen profile (this limitation is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
Regarding claim 54, Shachar teaches the biosensor system of claim 52 further comprising:
a communication interface (Fig. 9: SPI; ¶131: computer 806 including conventional input/output peripherals for data processing and display) coupled to the electronic reader for transmitting data from the electronic reader (Fig. 9: connected to the analog interface 802 and digital processing unit 804);
a data management computing device (Fig. 9; ¶131: computer 806) configured to receive data from the electronic reader via the communication interface (this limitation is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), said data management computing device comprising a memory (¶187: associated memory bank) coupled to a processor (Fig. 9: microcontroller) which is configured to execute programmed instructions comprising and stored in the memory (¶157: microcontroller 901 interfaced with a digital signal processing board and software; ¶165: the embedded software is designed to function as a state machine to control the impedance measurement sequence) to:
geographically map pathogen antigen, based on data received from electronic reader (¶165: to control the impedance measurement sequence of impedance converter 902 over output 714, and to further provide control of DDS 903 over output 912; further, this limitation is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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) 20 and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shachar in view of Sun (J. Sun, Magnetic Graphene Field-Effect Transistor Biosensor for Single-Strand DNA Detection, Nanoscale Research Letters 2019 (14), 248, pp. 1-8).
Regarding claims 20 and 53, Shachar discloses all limitations of claims 20 and 52 respectively, but fails to teach wherein the biosensor comprises an electromagnet positioned beneath the substrate of the biosensor.
However, Sun teaches a magnetic graphene field-effect transistor (GFET) biosensor ([Abstract]), in which a magnetic field rather than an electrical field is utilized to modulate the GFET conductivity (p. 2, col. 1, para. 2). The MGFETs include a substrate with two electrodes (Fig. 1: source S and drain D), having a graphene film grown between S and D and functionalized with probe aptamer, which would hybridization with cDNA, and a magnet positioned beneath the substrate (Fig. 1; p. 2, col. 2, para. 3).
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 Shachar by incorporating a electromagnet beneath the biosensor substrate as taught by Sun because the magnetic field is an alternative approach to be utilized to modulate the FET conductivity for impedance measurement as a biosensor (p. 2, col. 1, para. 2). 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). The substitution of one known element, i.e., the magnetic field, for another, i.e., electrical field, would yield nothing more than predictable results. MPEP 2141(III)(B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached M-F: 8:30am - 5:30pm.
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/C. SUN/Primary Examiner, Art Unit 1795