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 .
Drawings
The drawings are objected to because: Fig. 8 is unclear, blurry, and not complete, therefore is difficult to interpret. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: In the specification, paragraph [0186], it is suggested to recite “ESD” in an unabbreviated format to establish the acronym.
Appropriate correction is required.
Claim Objections
Claim 10 is objected to because of the following informalities: It is suggested to recite “ESD” in an unabbreviated format to establish the acronym. 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 7, 10, 13, and 17-18 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.
Regarding claim 7, claim 7 recites “a reference layer or receptor layer” in line 5. It is unclear if the reference or receptor layers of claim 7 is the same or different from the receptor layer and reference layer established in claim 1. For examination purposes, the reference or receptor layers of claim 7 are interpreted as the same as the reference and receptor layers of claim 1.
Regarding claim 10, claim 10 recites “the measurement mode” in line 5. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if the “measurement mode” is referring to the “differential measuring mode” or “absolute measuring mode” established in claim 6.
Regarding claim 13, claim 13 recites “the openings” in line 1. It is unclear if “the openings” is the same or different from “the opening for connecting the connection elements” and/or “a measurement opening” established in claim 12. It is suggested to utilize consistent terminology if referring to the same elements.
Regarding claim 17, claim 17 recites the limitation "the sensor housing" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 18, claim 18 recites the limitation "the measured signals" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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)(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.
(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.
Claims 1-3, 8, and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Baller et al. (US 7560070 B1).
Regarding claim 1, Baller teaches a sensor device (abstract; Figs. 4a-4d) for detecting at least one of an incidence, a concentration and an amount of an analyte in a sample (column 7, lines 55-58 teaches sensor system detecting ssDNA; column 8, lines 59-64 teaches monitoring molecular recognition by static cantilever bending, which is dependent on concentration; column 6, lines 20-35), the sensor device comprising:
a sensor (Figs. 4a-4d, sensor system 40) configured to convert at least one of chemical and biochemical information of an analyte in a sample into an electrical signal (column 8, lines 23-34 teaches the sensor system including cantilevers, and detecting a signal from bending of the cantilever; column 4, line 64 - column 5, line 22 teaches change in deflection from the cantilever is detected by optical or piezoresistive deflection sensors, therefore chemical and biochemical information of the analyte are converted to electrical signals for analysis);
connection electronics (column 5, lines 24-38 teaches detection circuitry and appropriate wiring for the cantilever); and
a housing (Fig. 8, housing 101),
wherein the sensor comprises a test cantilever (Figs. 4a-4c, measurement cantilever 41) that has a base (see below annotated Fig. 4a, interpreted as the base at location 1) and a deformable part (see below annotated Fig. 4a; interpreted as the part of the measurement cantilever 41, which is deformable as shown in Fig. 4b), wherein a receptor layer for selective reception of the analyte is applied at least to the deformable part of the test cantilever (see below annotated Fig. 4a; column 7, lines 59-64 teaches a first coating that is sensitive to a particular complementary DNA strand), and
wherein the sensor further comprises a reference cantilever (Figs. 4a-4c, reference cantilever 42) that has a base (see below annotated Fig. 4a, interpreted as the base at location 2) and a deformable part (see below annotated Fig. 4a; interpreted as the part of the reference cantilever 42, which is deformable as shown in Fig. 4c), wherein a reference layer for selective non-reception of the analyte is applied to the deformable part of the reference cantilever (see below annotated Fig. 4a; column 7, lines 64-67 teaches a reference coating to the top surface of the reference cantilever 42, which is less sensitive to the target DNA than the first coating, i.e. selective non-reception of the analyte).
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Annotated Fig. 4a of Baller
Regarding claim 2, Baller further teaches the sensor device according to claim 1, further comprising:
a passive test transducer arranged on the base of the test cantilever (see annotated Fig. 4a below; interpreted as the portion of the sensor 40 coupled to element 41 that is on the base) and an active test transducer arranged on the deformable part of the test cantilever (see annotated Fig. 4a below); and
a passive reference transducer arranged on the base of the reference cantilever (see annotated Fig. 4a below; interpreted as the portion of the sensor 40 coupled to element 42 that is on the base) and an active reference transducer arranged on the deformable part of the reference cantilever (see annotated Fig. 4a below),
wherein the respective active and passive reference transducers are configured to output an electrical signal corresponding to the at least one of the incidence, concentration and the amount of the analyte in the sample (column 5, lines 1-12 teaches a piezoresistive resistor is embedded at the end of the cantilever arm, where stress generates a signal that is measured; column 8, lines 61-64 teaches the sensor system monitors molecular recognition by static cantilever bending, where bending is dependent on concentration of oligonucleotides; column 10, lines 1-6 teaches changes in deflection of the cantilevers is detected which produces an output signal, i.e. photocurrents, which are analyzed to obtain information as to the amount of relative displacement of the cantilevers).
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Annotated Fig. 4a of Baller
Regarding claim 3, Baller further teaches the sensor device according to claim 2, wherein the selective reception of the analyte by the receptor layer and the selective non-reception of the analyte by the reference layer causes at least one of a deformation and a change in a surface stress of the test cantilever with respect to the reference cantilever (interpreted as functional limitation, see MPEP 2114; Figs. 4a-4b; column 5, lines 1-12 teaches a piezoresistive resistor is embedded at the end of the cantilever arm, where stress generates a signal that is measured; column 8, lines 61-64 teaches the sensor system monitors molecular recognition by static cantilever bending, where bending is dependent on concentration of oligonucleotides), and the at least one of the incidence, the concentration and the amount of the analyte is inferred by comparing forces detected by the respective transducers or by comparing surface stresses detected by the respective transducers (interpreted as an intended use of the sensor device see MPEP 2114; column 8, lines 4-12, lines 30-34, and lines 40-45 teaches determining the difference in deflection of the measurement and reference cantilever in order to allow for recognition of molecules).
Regarding claim 8, Baller further teaches the sensor device according to claim 1, wherein:
the receptor layer comprises single-strand DNA (ssDNA) and/or other DNA fragments that bind specifically to DNA fragments in the sample (column 7, lines 56-64) and the reference layer comprises single-strand DNA and/or other DNA fragments that do not bind to any chemical and/or biochemical and/or physical species in the sample (column 7, lines 64-67; Fig. 4b teaches the reference layer of reference cantilever 42 does not bind to any species in the sample while the receptor layer of test cantilever binds to species), but correspond to the receptor layer in terms of characteristic parameters (column 7, line 65 - column 8, line 21; Figs. 4a-4b).
Regarding claim 20, Baller further teaches the sensor device according to claim 3, wherein at least one of the deformation and the change in the surface stress is achieved in a longitudinal direction of at least one of the test cantilever and the reference cantilever (Figs. 4a-4c), wherein the longitudinal direction runs perpendicular to the base of the test cantilever and/or the reference cantilever (Figs. 4a-4c).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Baller as applied to claim 1 above, and further in view of Thaysen (US 20050034542 A1).
Regarding claim 4, Baller teaches the sensor device according to claim 1, wherein the deformable parts of the reference and test cantilevers (see above annotated Fig. 4) have identical geometric dimensions (column 8, lines 4-5), and wherein the bases of the reference and test cantilevers are arranged on a same overall base and the bases are formed in one piece with one another (see above annotated Fig. 4a, the bases of each cantilever are arranged on a same overall base and formed in one piece with one another).
Baller fails to teach: wherein a width of the deformable parts of the reference and test cantilevers corresponds to a length of the deformable parts of the reference and test cantilevers.
Thaysen teaches a sensor comprising sensor units in the form of a poly-cantilever structure (abstract). Thaysen teaches the cantilever structures can be square formed or rectangular formed (paragraphs [0023],[0034]). Thaysen teaches the cantilever-like structures may in principle have any shape as long as they are linked to each other and that they are relatively flexible (paragraph [0020]). 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 the reference and test cantilevers of Baller to incorporate the teachings of known shapes of cantilevers, such as a square, of Thaysen (paragraphs [0023],[0034]) to provide: wherein a width of the deformable parts of the reference and test cantilevers corresponds to a length of the deformable parts of the reference and test cantilevers. Doing so would have a reasonable expectation of successfully providing a cantilever structure that are flexible (Thaysen, paragraphs [0020],[0023],[0034]). Additionally, doing so would have been an obvious change of shape in view of Thaysen (MPEP 2144.04 (IV)(B); In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Baller as applied to claim 2 above, and further in view of Roukes et al. (US 7959873 B1).
Regarding claim 5, Baller fails to teach: the sensor device according to claim 2, wherein the respective transducers are electrically interconnected in a full bridge that is configured to build up a transverse bridge voltage (VB) based on electrical properties of the respective transducers.
Baller teaches: teaches detection circuitry and appropriate wiring for the cantilever (column 5, lines 24-38).
Roukes teaches a biosensor comprised of free and biofunctionalized recognition self-sensing nanocantilever (abstract). Roukes teaches differential signal detection is employed to reduce common-mode signal due to the environment in which the sensor resides (column 2, lines 15-18). Roukes teaches in order to compensate the large environmental background noise and provide a differential signal between the reference cantilever and recognition cantilever, the two cantilevers are incorporated into two arms of a Wheatstone bridge, i.e. full bridge (note that the instant application, paragraph [0110] discusses a full bridge is also known by the names of Wheatstone measuring bridge, therefore Rouke’s Wheatstone bridge is interpreted as a full bridge); and their difference is measured through another differential amplifier to remove background noise and obtain high gain (column 6, lines 52-62).
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 the sensor device of Baller to incorporate the teachings of a biosensor comprising reference and recognition cantilevers connected in a Wheatstone bridge of Roukes (column 2, lines 15-18; column 6, lines 52-62) to provide: the sensor device according to claim 2, wherein the respective transducers are electrically interconnected in a full bridge that is configured to build up a transverse bridge voltage (VB) based on electrical properties of the respective transducers. Doing so would have a reasonable expectation of successfully improve electronic signal measurement by reducing noise and obtain high gain as discussed by Roukes.
Regarding claim 6, Baller fails to teach: the sensor device according to claim 5, further comprising an A/D converter configured to convert the transverse bridge voltage (VB) into a digital signal and that is configured to be operated in at least one of a differential measuring mode and in an absolute measuring mode using an A/D converter logic unit.
Baller teaches an acquisition and control unit that processes an amplifier’s output signal, and the acquisition and control unit comprises an analog-to-digital converter for generating an output signal that is forwarded to a computer to be processed and recorded (column 10, lines 38-45).
Roukes teaches differential signal detection is employed to reduce common-mode signal due to the environment in which the sensor resides (column 2, lines 15-18). Roukes teaches in order to compensate the large environmental background noise and provide a differential signal between the reference cantilever and recognition cantilever, the two cantilevers are incorporated into two arms of a Wheatstone bridge, i.e. full bridge (note that the instant application, paragraph [0110] discusses a full bridge is also known by the names of Wheatstone measuring bridge, therefore Rouke’s Wheatstone bridge is interpreted as a full bridge); and their difference is measured through another differential amplifier to remove background noise and obtain high gain (column 6, lines 52-62).
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 the sensor device of modified Baller to incorporate the teachings of an A/D converter of Baller (column 10, lines 38-45) and the teachings of measuring differential signal from cantilevers of Roukes (column 2, lines 15-18; column 6, lines 52-62) to provide: the sensor device according to claim 5, further comprising an A/D converter configured to convert the transverse bridge voltage (VB) into a digital signal and that is configured to be operated in at least one of a differential measuring mode and in an absolute measuring mode using an A/D converter logic unit. Doing so would have a reasonable expectation of successfully improving analysis of output signals from the cantilevers while removing noise and obtaining a high gain.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Baller as applied to claim 1 above, and further in view of Ndieyira (US 20200215537 A1; cited in the IDS filed 03/08/2024) and Nawana et al. (US 20210293816 A1).
Regarding claim 7, Baller further teaches the sensor device according to claim 1, further comprising: a self-assembling monolayer applied to the activation layer (column 5, lines 55-65 and column 7, lines 32-47 teach the surface of the cantilever is functionalized by self assembled monolayers, i.e. thiols);
an activation layer applied to upper surfaces of the reference and test cantilevers (Fig. 5 and column 8, lines 53-55 teaches a gold layer 44 applied to the upper surface of the cantilever; column 9, lines 8-13 teaches one side of the Si cantilever is covered by a gold layer; since Fig. 4 shows both cantilevers 41,42 with recognition molecules, it is implied that each cantilever comprises a gold layer the upper surfaces); and
at least one of a reference layer or receptor layer applied to the self-assembling monolayer of the reference and test cantilever, respectively (column 8, lines 13-22 and lines 50-58 teach cantilevers are functionalized by oligonucleotides modified by a thiol group at their 5’ end; therefore, the reference or receptor layer is applied to the self assembling monolayer, i.e. thiols to the respective reference and test cantilevers).
Baller fails to teach:
a passivation layer applied to lower surfaces of the reference and test cantilevers;
wherein the receptor layer comprises antibodies for an antigen and the reference layer comprises an antigen-specific isotype control antibody according to the antibody of the receptor layer.
Baller teaches one surface of the cantilever or membrane has to be functionalized individually according to the analyte of choice, e.g., by proteins (antigen--antibodies, receptor--ligands, enzymes), oligonucleotides, self assembled monolayers (thiols), polymeric layers, cells or microorganisms (column 5, lines 60-64; column 7, lines 32-38).
Ndieyira teaches a cantilever sensor (abstract). Ndieyira teaches the cantilever can be passivated on the side that is not coated with the SAM (paragraph [0013]). Ndieyira teaches the cantilever is passivated on the side opposite to the gold layer (i.e. bottom side), wherein the purpose of passivation of the bottom surface is to help in avoiding unwanted functionalization of the bottom surface with receptors or probe molecules, consequently preventing probe molecule (ligand) adsorption that would alter sensing results (paragraph [0050]). Ndieyira teaches a probe molecule to interact with specificity and sensitivity with another molecule, wherein the probe molecule is a receptor such as an antibody to provide antibody-antigen interaction (paragraphs [0046]-[0047]).
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 the reference and test cantilevers to incorporate Baller’s teachings of the cantilever functionalized for antigen-antibodies (column 5, lines 60-64; column 7, lines 32-38) and Ndieyira’s teachings of the bottom side of cantilevers coated with a passivation layer (paragraphs [0013],[0050]) and a probe molecule as an antibody (paragraphs [0046]-[0047]) to provide: a passivation layer applied to lower surfaces of the reference and test cantilevers; and wherein the receptor layer comprises antibodies for an antigen. Doing so would have a reasonable expectation of successfully improving specificity and sensitivity to desired analytes and avoiding unwanted functionalization at the bottom surface of the cantilevers.
Modified Baller fails to teach: the reference layer comprises an antigen-specific isotype control antibody according to the antibody of the receptor layer.
Nawana teaches a sensor for detecting SARS-Cov-2 virus in a sample, which includes binding agents coupled to a graphene layer (abstract). Nawana teaches the graphene layer was functionalized with anti-spike protein antibodies and unfunctionalized portions were passivated (paragraph [0133]). Nawana teaches a control sensor was also fabricated, where the graphene layer was functionalized with isotype control antibodies; and the signals from the sensor and control sensor were compared (paragraph [0133]). Nawana teaches irrelevant protein bound to plates used as a negative control (paragraphs [0131],[0132]).
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 the reference layer of modified Baller to incorporate the teachings of a control sensor comprising isotype control antibodies and the use of negative controls of Nawana (paragraphs [0131]-[0133]) to provide: the reference layer comprises an antigen-specific isotype control antibody according to the antibody of the receptor layer. Doing so would have a reasonable expectation of successfully improving comparison of the reference and test cantilevers for a desired analyte via use of a control such as a negative control.
Claim 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Baller in view of Roukes as applied to claim 6 above, and further in view of Brancazio et al. (US 20080118402 A1).
Regarding claim 9, modified Baller fails to teach the sensor device according to claim 6, wherein the connection electronics comprise a printable circuit board that is configured to ensure the electrical communication between a connection socket and the sensor.
Baller teaches: teaches detection circuitry and appropriate wiring for the cantilever (column 5, lines 24-38).
Brancazio teaches a compact system that repeatably makes fluid, mechanical, and electrical contact enabling reliable sample analysis (paragraph [0059]). Brancazio teaches various electronic configurations employed in the system for connecting elements with a circuit, such as spring-loaded pins mounted in a socket that is screwed to a printed circuit board, wherein the printed circuit board has gold coated pads that contact the pins (paragraph [0120]). Brancazio teaches a socket containing complementary electrical contact points on the same printed circuit board as an analyzer circuitry (paragraph [0123]). Brancazio teaches a cover that includes a frame and a socket within the frame, wherein electrical connections are disposed on the socket and a plurality of magnets are disposed in an inner frame (paragraph [0139]; and electrical contact points on the socket can contact the electrical contact pads on the processing device and the plurality of magnets disposed in the socket can align with the processing device (paragraph [0140]). Brancazio teaches alignment of magnets with the processing device is ensured when registration features on the socket engage with registration features on the supporting surface, where the magnets are disposed on the socket (paragraph [0016]).
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 the sensor device and the connection electronics of modified Baller to incorporate the teachings of a system for sample analysis that includes electronic configurations for connecting elements with a printed circuit board, such an electrical connection via a socket, of Brancazio (paragraphs [0016], [0059], [0120], [0123], [0139], [0140]) to provide: the sensor device according to claim 6, wherein the connection electronics comprise a printable circuit board that is configured to ensure the electrical communication between a connection socket and the sensor. Doing so would have a reasonable expectation of successfully improving transmission and analysis of data from the sensor device and ensuring proper electrical communication between electrical elements.
Regarding claim 10, modified Baller fails to teach the sensor device according to claim 9, wherein the connection socket and the printable circuit board are configured to perform at least one of:
implementing a voltage supply for the full bridge, reading the transverse bridge voltage (VB), reading the output signal from the A/D converter, setting the measuring mode of the A/D converter logic unit, and implementing ESD protection.
Baller teaches: teaches detection circuitry and appropriate wiring for the cantilever (column 5, lines 24-38). Baller teaches an acquisition and control unit that processes an amplifier’s output signal, and the acquisition and control unit comprises an analog-to-digital converter for generating an output signal that is forwarded to a computer to be processed and recorded (column 10, lines 38-45).
Brancazio teaches a compact system that repeatably makes fluid, mechanical, and electrical contact enabling reliable sample analysis (paragraph [0059]). Brancazio teaches various electronic configurations employed in the system for connecting elements with a circuit, such as spring-loaded pins mounted in a socket that is screwed to a printed circuit board, wherein the printed circuit board has gold coated pads that contact the pins (paragraph [0120]). Brancazio teaches a socket containing complementary electrical contact points on the same printed circuit board as an analyzer circuitry (paragraph [0123]). Brancazio teaches a cover that includes a frame and a socket within the frame, wherein electrical connections are disposed on the socket and a plurality of magnets are disposed in an inner frame (paragraph [0139]; and electrical contact points on the socket can contact the electrical contact pads on the processing device and the plurality of magnets disposed in the socket can align with the processing device (paragraph [0140]). Brancazio teaches alignment of magnets with the processing device is ensured when registration features on the socket engage with registration features on the supporting surface, where the magnets are disposed on the socket (paragraph [0016]).
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 the sensor device and the connection electronics of modified Baller to incorporate the teachings of reading the output signal from the A/D converter of Baller (column 10, lines 38-45), the teachings of a system for sample analysis that includes electronic configurations for connecting elements with a printed circuit board, such an electrical connection via a socket, of Brancazio (paragraphs [0016], [0059], [0120], [0123], [0139], [0140]) to provide: wherein the connection socket and the printable circuit board are configured to perform at least one of: implementing a voltage supply for the full bridge, reading the transverse bridge voltage (VB), reading the output signal from the A/D converter, setting the measuring mode of the A/D converter logic unit, and implementing ESD protection. Doing so would have a reasonable expectation of successfully improving transmission, control, and analysis of data from the sensor device and ensuring proper electrical communication between electrical elements.
Regarding claim 11, modified Baller fails to teach the sensor device according to claim 9, wherein the connection socket is a magnetic connection socket.
Brancazio teaches a compact system that repeatably makes fluid, mechanical, and electrical contact enabling reliable sample analysis (paragraph [0059]). Brancazio teaches various electronic configurations employed in the system for connecting elements with a circuit, such as spring-loaded pins mounted in a socket that is screwed to a printed circuit board, wherein the printed circuit board has gold coated pads that contact the pins (paragraph [0120]). Brancazio teaches a socket containing complementary electrical contact points on the same printed circuit board as an analyzer circuitry (paragraph [0123]). Brancazio teaches a cover that includes a frame and a socket within the frame, wherein electrical connections are disposed on the socket and a plurality of magnets are disposed in an inner frame (paragraph [0139]; and electrical contact points on the socket can contact the electrical contact pads on the processing device and the plurality of magnets disposed in the socket can align with the processing device (paragraph [0140]). Brancazio teaches alignment of magnets with the processing device is ensured when registration features on the socket engage with registration features on the supporting surface, where the magnets are disposed on the socket (paragraph [0016]).
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 the sensor device and the connection electronics of modified Baller to incorporate the teachings of a system for sample analysis that includes a socket with magnets for electrical connection, of Brancazio (paragraphs [0016], [0059], [0120], [0123], [0139], [0140]) to provide: the sensor device according to claim 9, wherein the connection socket is a magnetic connection socket. Doing so would have a reasonable expectation of successfully improving alignment of electrical components for proper electrical connections as taught by Brancazio.
Claims 12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Baller as applied to claim 1 above, and further in view of Mutharasan et al. (US 20080034840 A1; cited in the IDS filed 04/30/2025).
Regarding claim 12, Baller fails to teach: the sensor device according to claim 1, wherein: the housing encloses the sensor and the connection electronics, the housing has an opening for connecting the connection electronics, and the housing has a measurement opening through which at least the deformable parts of the cantilevers of the sensor protrude from the housing.
Mutharasan teaches flow cells configured for piezoelectric cantilever sensors for direct, sensitive detection of analytes in fluid media (abstract). Mutharasan teaches a piezoelectric-excited millimeter-sized cantilever (PEMC) sensor (paragraph [0056] and Fig. 8, element 12) in a housing (sensor case 52). Mutharasan teaches the housing encloses the PEMC sensor and connection electronics (Fig. 8 and paragraph [0056]), wherein the housing as an opening for the connection electronics (Fig. 8 shows leads 60 exiting the casing 52, therefore the casing has openings), and the housing has a measurement opening through which at least a deformable parts of the cantilever of the sensor protrude from the housing (Fig. 8 and paragraph [0056] teaches the piezoelectric layer 14 protrudes from the casing 52; paragraph [0048] teaches bending stress in the sensing piezoelectric layer, therefore is deformable).
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 the housing of Baller to incorporate teachings of a housing for a cantilever sensor and connection electronics of Mutharasan (Fig. 8; paragraphs [0048],[0056]) to provide: the sensor device according to claim 1, wherein: the housing encloses the sensor and the connection electronics, the housing has an opening for connecting the connection electronics, and the housing has a measurement opening through which at least the deformable parts of the cantilevers of the sensor protrude from the housing. Doing so would have a reasonable expectation of successfully improving supporting and protection of the sensor and connection electronics while allowing for the sensor to interact and analyze with a sample.
Regarding claim 14, modified Baller fails to teach the sensor device according to claim 12, wherein the housing comprises two parts that are connected to one another by a snap-in connection.
Baller teaches the invention also concerns a container comprising a lid that is connected to the container, such that the container is open if the lid is bent (column 2, lines 56-62).
Mutharasan teaches a flow cell and sensor are separate and detachable, wherein the flow can and sensor can be attached via any appropriate means, such as a threaded insertion, snap and lock insertion, or a combination thereof (paragraph [0064]), wherein the unit can be reusable and/or disposable (paragraph [0064])
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 the housing of modified Baller to incorporate the teachings of a device comprising multiple parts (Baller, column 2, lines 56-62; Mutharasan, paragraph [0064]) and the teachings of attachment of components via snap and lock insertion of Mutharasan (paragraph [0064]) to provide: the sensor device according to claim 12, wherein the housing comprises two parts that are connected to one another by a snap-in connection. Doing so would have a reasonable expectation of successfully providing detachable components as taught by Mutharasan, therefore improving connection and separation of components of the housing for reuse or disposal (Mutharasan, paragraph [0064]).
Regarding claim 15, modified Baller fails to teach the sensor device according to claim 12, wherein the measurement opening is surrounded by a thread that corresponds to a thread of a sample vial.
Mutharasan teaches flow cells configured for piezoelectric cantilever sensors for direct, sensitive detection of analytes in fluid media (abstract). Mutharasan teaches a flow cell and sensor are separate and detachable, wherein the flow can and sensor can be attached via any appropriate means, such as a threaded insertion, snap and lock insertion, or a combination thereof (paragraph [0064]), wherein the unit can be reusable and/or disposable (paragraph [0064]). Mutharasan teaches the sensor connected to a sample vial (Fig. 8 shows sensor casing 52 connected to a flow cell, i.e. sample vial; Figs. 10-11 teaches the sensor casing 52 connected to a vial of a flow cell 48, i.e. sample vial).
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 the measurement opening of modified Baller the teachings of attaching a sensor to a sample vial and attachment via a threaded insertion of Mutharasan (paragraph [0064]; Figs. 8,10-11) to provide: the sensor device according to claim 12, wherein the measurement opening is surrounded by a thread that corresponds to a thread of a sample vial. Doing so would have a reasonable expectation of successfully providing detachable components as taught by Mutharasan, therefore improving connection and separation of the sensor device with a sample vial for analysis (Mutharasan, paragraph [0064]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Baller in view of Mutharasan as applied to claim 12 above, and further in view of Benam et al. (US 20190376950 A1).
Regarding claim 13, modified Baller fails to teach the sensor device according to claim 12, wherein the openings are sealed by rubber seals.
Mutharasan teaches seals, such as o-rings, or any suitable fittings can provide a seal to the flow cell and sensing casing (paragraph [0056]).
Benam teaches a system comprising a biochip (abstract). Benam teaches a chamber, where an opening is sealed using a rubber stopper that allows sealing of the opening while still permitting tubing to get into the chamber (paragraph [0021]).
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 the openings of modified Baller to incorporate the teachings of providing seals of Mutharasan (paragraph [0056]) and a rubber stopper of Benam (paragraph [0021]) to provide: the sensor device according to claim 12, wherein the openings are sealed by rubber seals. Doing so would have a reasonable expectation of successfully improving sealing of the openings while allowing for desired elements to enter or exit the sensor device.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Baller in view of Mutharasan as applied to claim 12 above, and further in view of Fruhberger (US 7340941 B1).
Regarding claim 16, modified Baller fails to teach the sensor device according to claim 12, wherein the housing has a protective cap for the deformable parts of the reference and test cantilevers, with the protective cap configured to protect the deformable parts against any direct mechanical action of the sample and allows a controlled supply of the sample to the deformable parts of the reference and test cantilevers.
Fruhberger teaches sensors for determining the amount of a chemical (abstract), the sensor comprising a microcantilever beam (abstract). Fruhberger teaches a screen or microporous filter, i.e. protective cap, can be placed over the sensor chip cavity to protect the microcantilever beams from debris (column 10, lines 58-60).
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 the housing of modified Baller to incorporate the teachings of a screen or microporous filter to protect the microcantilevers of Fruhberger (column 10, lines 58-60) to provide: the sensor device according to claim 12, wherein the housing has a protective cap for the deformable parts of the reference and test cantilevers, with the protective cap configured to protect the deformable parts against any direct mechanical action of the sample and allows a controlled supply of the sample to the deformable parts of the reference and test cantilevers. Doing so would have a reasonable expectation of successfully improving protection of the cantilevers while allowing for sample to be supplied to the cantilevers for analysis.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Baller in view of Roukes and Brancazio as applied to claim 9 above, and further in view of Dussault (US 5421189 A).
Regarding claim 17, modified Baller fails to teach the sensor device according to claim 9, wherein the printable circuit board has an ESD protection contact or grounding contact, at least part of the sensor housing has a conductivity of less than 1GΩ and the at least one conductive housing part is electrically conductively connected to the printable circuit board.
Brancazio teaches various electronic configurations employed in the system, wherein the printed circuit board is connected to a spring side of a pogo, wherein other pogo pins connect chip, ground, RTD traces, and other electrical features (paragraph [0120]).
Dussault teaches an electrochemical/gas analyzer providing protection for high impedance input electronics against ESD damage (abstract). Dussault teaches a printed circuit board and housing (column 2, line 25), and diagnostic circuitry includes a path to electrical ground (column 2, lines 29-39), and static potential built up on the sensor body is drained to ground and the high impedance front-end electronics are protected from ESD damage (column 2, lines 39-42).
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 the sensor device of modified Baller to incorporate the teachings of the printed circuit board connected to ground of Brancazio (paragraph [0120]) and the teachings of a printed board and housing, which includes a path to ground, and a sensor body is protected from ESD damage of Dussault (abstract; column 2, lines 25-42) to provide: the sensor device according to claim 9, wherein the printable circuit board has an ESD protection contact or grounding contact, at least part of the sensor housing has a conductivity of less than 1GΩ and the at least one conductive housing part is electrically conductively connected to the printable circuit board. Doing so would have a reasonable expectation of successfully improving protection of the sensor device from ESD damage as discussed by Dussault.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Baller in view of Roukes as applied to claim 6 above, and further in view of Su et al. (WO 2004029625 A2; cited in the IDS filed 05/03/2023).
Regarding claim 18, modified Baller fails to teach the sensor device according to claim 6, wherein: the sensor device is connected to an evaluation station that is configured to evaluate the measured signals from at least one of the transverse bridge voltage detector and the A/D converter, and the evaluation station is configured to communicate with a computer system in a wired or wireless manner, wherein a display of the evaluation is displayed on the computer system.
Baller teaches an acquisition and control unit that processes an amplifier’s output signal, and the acquisition and control unit comprises an analog-to-digital converter for generating an output signal that is forwarded to a computer to be processed and recorded (column 10, lines 38-45).
Su teaches an apparatus for detection and/or identification of target analytes using probe molecules attached to cantilevers (abstract). Su teaches the cantilevers, detection unit, and other elements of the apparatus are interfaced with a data processing and control system for data analysis (paragraphs [0087]-[0088]). Su teaches the system incorporates a system comprising a bus or other communication means for communicating information, and a processor coupled with the bus for processing information (paragraph [0087]), wherein the computer includes a display (paragraph [0088]). Su teaches software, i.e. evaluation station, are used to analyze data obtained from the detection unit (paragraph [0092]).
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 the sensor device of modified Baller to incorporate the teachings of evaluating measured signals with a computer of Baller (column 10, lines 38-45) and the teachings of a computer comprising a processor and software for analyzing data and a display of Su (paragraphs [0087]-[0088],[0092]) to provide: the sensor device according to claim 6, wherein: the sensor device is connected to an evaluation station that is configured to evaluate the measured signals from at least one of the transverse bridge voltage detector and the A/D converter, and the evaluation station is configured to communicate with a computer system in a wired or wireless manner, wherein a display of the evaluation is displayed on the computer system. Doing so would have a reasonable expectation of successfully improving computational analysis of data obtained from the cantilevers and display of data to a user.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Baller as applied to claim 3 above, and further in view of Thaysen (US 20060060003 A1; herein “US ‘003”).
Regarding claim 19, modified Baller fails to teach the sensor device according to claim 3, wherein at least one of the deformation and the change in the surface stress is achieved in a transverse direction of at least one of the test cantilever and the reference cantilever, with the transverse direction running parallel to the base of the test cantilever and/or of the reference cantilever.
US ‘003 teaches a sensor comprising a sensor unit, such as a cantilever, wherein the sensor unit comprises a capture surface area and a piezoresistive detection system for direct detection of stress change of the sensor (abstract); wherein the objective of the invention is to improve signal or signal/noise ratio of the sensor (paragraph [0007]). US ‘003 teaches the piezoresistive element has a longitudinal direction and a transverse direction along the length of the piezoresistive element when an electrical field is applied over the piezoresistive element and the piezoresistive element is subjected to a stress (paragraph [0026]). US ‘003 teaches since the surface stress changed is observed as a relative change in the resistance it has been found that both the transverse and longitudinal stress has to be considered, and furthermore, it has been found that they can be considered equally, irrespectively of the width and length of the piezoresistive material, when the cantilever is not subjected to other forces, such as a resistive force generated due to clamping (paragraph [0070]).
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 the sensor device of modified Baller to incorporate the teachings of considering both transverse and longitudinal stress of piezoresistive elements of a detection system of US ‘003 (abstract; paragraphs [0007],[0026],[0070]) to provide: the sensor device according to claim 3, wherein at least one of the deformation and the change in the surface stress is achieved in a transverse direction of at least one of the test cantilever and the reference cantilever, with the transverse direction running parallel to the base of the test cantilever and/or of the reference cantilever. Doing so would have a reasonable expectation of successfully improving characterization and analysis of surface stress of the cantilevers, therefore improving signal or signal to noise ratio as taught by US ‘003 (abstract; paragraphs [0007],[0026],[0070]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kale et al. (US 20190187138 A1; cited in the IDS filed 05/03/2023) teaches a sensor device (Figs. 1-7; abstract) for detecting at least one of an incidence, a concentration and an amount of an analyte in a sample, the sensor device (abstract) comprising:
a sensor (Figs. 1A-1D, detection unit 118 comprising detection micro-cantilevers 122, adjunct micro-cantilevers 124, and reference micro-cantilevers 126) configured to convert at least one of chemical and biochemical information of an analyte in a sample into an electrical signal (paragraph [0006] teaches the sensor comprises detection micro-cantilevers and reference micro-cantilevers, wherein the detecting binding of an analyte biomolecule to the detection micro-cantilevers by measuring a change in surface stress via changes in resistances measured by a digital signal);
connection electronics (Fig. 1B, electrical contact pads 132); and
a housing (Fig. 1A, interpreted as the elements that support and house the micro-cantilevers of the detection unit or cartridge 118; additionally, Fig. 1A inherently teaches a housing for the micro-cantilevers 122, 124, 126, since Fig. 1A teaches “Cartridge” 118, which is depicted as encompassing the micro-cantilevers, and one of ordinary skill in the art would recognize the cartridge would at least support or house the micro-cantilevers in connection with the microfluidic chamber 102),
wherein the sensor (Figs. 1A-1D, detection unit 118 comprising detection micro-cantilevers 122, adjunct micro-cantilevers 124, and reference micro-cantilevers 126) comprises a test cantilever (detection micro-cantilevers 122) that has a base (Fig. 1D and paragraphs [0027],[0048], second layer, i.e. structural layer) and a deformable part (Fig. 1D and paragraphs [0027],[0048], piezoresistive layer), wherein a receptor layer (Fig. 1D and paragraphs [0027],[0048], teaches a first layer of the detection micro-cantilevers are immobilized with receptor biomolecules, e.g. antibody) for selective reception of the analyte is applied at least to the deformable part of the test cantilever (paragraphs [0027],[0048]), and
wherein the sensor (Figs. 1A-1D, detection unit 118 comprising detection micro-cantilevers 122, adjunct micro-cantilevers 124, and reference micro-cantilevers 126) further comprises a reference cantilever (reference micro-cantilevers 126) that has a base (paragraphs [0028]-[0029],[0039], second layer, i.e. structural layer) and a deformable part (paragraph [0030], piezoresistive layer), wherein a reference layer (paragraphs [0028]-[0029], teaches a first layer, i.e. immobilization layer, comprising an amine blocker) for selective non-reception of the analyte is applied to the deformable part of the reference cantilever (paragraph [0028],[0039]-[0040] teaches the micro-cantilever having an immobilization layer, which is on the piezoresistive layer, coated with an amine blocker; therefore, the amine blocker allows for non-reception of the analyte since analytes do not bind to the amine blocker).
De Charmoy Grey et al. (US 657020 B1; cited in the IDS filed 05/03/2023; herein “Grey”) teaches a sensor device (Figs. 1-14; abstract) for detecting at least one of an incidence, a concentration and an amount of an analyte in a sample, the sensor device (column 4, lines 11-25 teaches detecting the presence, i.e. incidence, of a substance in a fluid; column 18, lines 6-7 teaches measuring concentration in liquid) comprising:
a sensor (Figs. 12-13) configured to convert at least one of chemical and biochemical information of an analyte in a sample into an electrical signal (column 9, lines 42-53 teaches a biochemical reaction at a micro-cantilever results in a change in surface stress, therefore allowing for detection of biochemical reactions; column 4, lines 51-58 teaches the detecting means comprises a piezoresistive element as part of a flexible member, and forms a balance bridge; therefore, the micro-cantilever’s change of stress allows detection of biochemical reactions via measurement of electrical signals);
connection electronics (Figs. 4, 14, and column 10, lines 59-60 teaches electronic feed-throughs 4, i.e. connection electronics, which ensure electrical contact to the piezoresistive elements); and
a housing (Figs. 3, 12-13, and 14 teaches a body, i.e. housing, surrounding and supporting the sensor components),
wherein the sensor (Figs. 12-13) comprises a test cantilever (coated cantilever) that has a base and a deformable part (column 4, lines 51-56 teaches a first flexible member, i.e. base, comprising a piezoresistive element, i.e. deformable part; column 10, lines 41-58 teaches microcantilevers comprise a silicon, silicon oxide and silicon nitride, i.e. base, and piezoresistors, i.e. deformable part, are placed on top of the micro-cantilevers), wherein a receptor layer for selective reception of the analyte is applied at least to the deformable part of the test cantilever (column 16, lines 17-39 teaches functionalization of the micro-cantilevers with thin film layer which is used to bind molecules), and
wherein the sensor (Figs. 12-13) further comprises a reference cantilever (reference cantilever) that has a base and a deformable part (column 5, lines 9-19 teaches a second flexible member, i.e. base, comprising a piezoresistive element, i.e. deformable part; column 10, lines 41-58 teaches microcantilevers comprise a silicon, silicon oxide and silicon nitride, i.e. base, and piezoresistors, i.e. deformable part, are placed on top of the micro-cantilevers), wherein a reference layer (column 17, lines 18-27 teaches the reference micro-cantilever is not coated with a detector film, but is coated with another film, i.e. reference layer, that does not act as a detector or which detects a second substance) for selective non-reception of the analyte is applied to the deformable part of the reference cantilever (column 17, lines 18-27 teaches the reference micro-cantilever is not coated with a detector film, but is coated with another film, i.e. reference layer, that does not act as a detector or which detects a second substance; therefore, the reference layer is for selective non-reception of the analyte, or does not act to detect with the analyte).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758