DETAILED ACTION
Applicant’s arguments, filed on 06/22/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 06/22/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-17 and 19-21 are the current claims hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 12 is objected to because of the following informalities:
In claim 12, line 1 “field effect” should read “field-effect” to keep consistent terminology throughout the claims
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 2-10, 13-17, and 19-21 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 2, the claim recites the limitation “a microcantilever” in line 2. It is unclear if this limitation is meant to refer to the microcantilever from claim 1, line 3, or a different microcantilever. If it is meant to refer to the cantilever from claim 1, it needs to refer back to it. If it is meant to refer to a different microcantilever, it needs to be distinguished from the microcantilever from claim 1. For purposes of examination, it is being interpreted as referring to the microcantilever from claim 1. Claims 3-10 are also rejected due to their dependence on claim 2.
Regarding claim 13, the claim recites the limitation “one or more target antigen” in line 1. It is unclear if this limitation is meant to refer to the target antigen from claim 1, line 2, or different target antigen. If it is meant to refer to the target antigen from claim 1, it needs to refer back to it. If it is meant to refer to different target antigens, it needs to be distinguished from the target antigen from claim 1. For purposes of examination, it is being interpreted as referring to the target antigen from claim 1. Claims 14-17 are also rejected due to their dependence on claim 13.
Further regarding claim 13, the claim recites the limitation “one or more target antibody” in lines 1-2. It is unclear if this limitation is meant to refer to the target antibody from claim 1, line 2, or different target antibodies. If it is meant to refer to the target antibody from claim 1, it needs to refer back to it. If it is meant to refer to different target antibodies, it needs to be distinguished from the target antibody from claim 1. For purposes of examination, it is being interpreted as referring to the target antibody from claim 1. Claims 14-17 are also rejected due to their dependence on claim 13.
Further regarding claim 13, the claim recites the limitation “one or more nanomechanical sensors” in lines 2-3. It is unclear if this limitation is meant to include the nanomechanical sensor from claim 1, line 1, or different nanomechanical sensors. If it is meant to refer to the nanomechanical sensor from claim 1, it needs to refer back to it. If it is meant to refer to different nanomechanical sensors, it needs to be distinguished from the nanomechanical sensor from claim 1. For purposes of examination, it is being interpreted as referring to the nanomechanical sensor from claim 1. Claims 14-17 are also rejected due to their dependence on claim 13.
Regarding claim 14, the claim recites the limitation “a bending moment” in line 1. It is unclear if this limitation is meant to refer to the bending moment from claim 1, line 3, or a different bending moment. If it is meant to refer to the bending moment from claim 1, it needs to refer back to it. If it is meant to refer to a different bending moment, it needs to be distinguished from the bending moment from claim 1. For purposes of examination, it is being interpreted as referring to the bending moment from claim 1.
Regarding claim 15, the claim recites the limitation “a first nanomechanical sensor and a second nanomechanical sensor” in line 2. It is unclear if this limitation is meant to refer to the one or more nanomechanical sensors from claim 13, lines 2-3. If it is meant to refer to the one or more nanomechanical sensors from claim 13, it needs to refer to it. If it is meant to refer to different nanomechanical sensors, it needs to be distinguished from the one or more nanomechanical sensors from claim 13. For purposes of examination, it is being interpreted as referring to the one or more nanomechanical sensors from claim 13.
Further regarding claim 15, the claim recites the limitation “one or more target antibody” in lines 4-5. It is unclear if this limitation is meant to refer to target antibody from claim 1, line 2, or a different target antibody. If it is meant to refer to the target antibody from claim 1, it needs to refer back to it. If it is meant to refer to different target antibodies, it needs to be distinguished from the target antibody from claim 1. For purposes of examination, it is being interpreted as referring to the target antibody from claim 1.
Further regarding claim 15, the claim recites the limitation “the one or more target antigen” in line 5. It is unclear what this limitation is meant to refer to, as no one or more target antigen has been introduced. Additionally, it is unclear if this limitation is meant to refer to the target antigen from claim 1, line 2, or a different target antigen. If it is meant to refer to the target antigen from claim 1, it needs to refer back to it. If it is meant to refer to a different target antigen, it needs to be distinguished from the target antigen from claim 1. For purposes of examination, it is being interpreted as referring to the target antigen from claim 1.
Regarding claim 17, the claim recites the limitation “the sensor” in line 2. It is unclear what sensor this limitation is referring to, as multiple sensors have been introduced in claim 13, which claim 17 is dependent on. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to any of the previously introduced sensors.
Regarding claim 19, the claim recites the limitation “a target antigen” in line 1. It is unclear if this limitation is meant to refer to the target antigen from claim 1, line 2, or a different target antigen. If it is meant to refer to the target antigen from claim 1, it needs to refer back to it. If it is meant to refer to a different target antigen, it needs to be distinguished from the target antigen from claim 1. For purposes of examination, it is being interpreted as referring to the target antigen from claim 1. Claims 20-21 are also rejected due to their dependence on claim 19.
Further regarding claim 19, the claim recites the limitation “a target antibody” in line 1. It is unclear if this limitation is meant to refer to target antibody from claim 1, line 2, or a different target antibody. If it is meant to refer to the target antibody from claim 1, it needs to refer back to it. If it is meant to refer to different target antibodies, it needs to be distinguished from the target antibody from claim 1. For purposes of examination, it is being interpreted as referring to the target antibody from claim 1. Claims 20-21 are also rejected due to their dependence on claim 19.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1, 13-15, 19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Majumdar (US 20040152211).
Regarding independent claim 1, Majumdar teaches a nanomechanical sensor comprising an antibody-functionalized microcantilever ([0006]: “The present invention provides systems and techniques for detecting different molecules (including biomolecules) using an array of sensors. In preferred embodiments, the sensors may be micromechanical surface stress sensors (MSSS), such as microcantilevers and membranes. Preferably, such sensors change in response to one or more molecular or biomolecular interactions”), wherein a target antigen or a target antibody bound to the antibody-functionalized microcantilever induces a detectable bending moment in the microcantilever ([0064]: “The sensors exhibit a physical change in response to a biological interaction between probe molecules and target molecules. For example, when a target molecule 230 binds to a probe molecule 225, the surface stress of cantilever 210 changes, and cantilever 210 deflects in the -z direction. The amount of deflection provides a measure of the concentration of target molecules in a fluid”; [0004]: “in order to detect a particular antigen, an appropriate antibody may used as a probe molecule”; [0151]: “When target molecules bind specifically to probe molecules attached to a surface of a microcantilever, there is a change in surface stress. The change in surface stress causes the cantilever to bend (FIG. 2)”).
Regarding claim 13, Majumdar teaches a system for detection of one or more target antigen or one or more target antibody in a sample (Abstract: “Systems and techniques for biomechanical analysis are described. Multiple sensors are used to detect different molecules and/or to analyze multiple samples. A property of the sensors changes in response to a target molecule. The change in the property is detected, which may provide a measure of the concentration of the target molecule.”), the system comprising one or more nanomechanical sensors according to claim 1 ([0006]: “The present invention provides systems and techniques for detecting different molecules (including biomolecules) using an array of sensors. In preferred embodiments, the sensors may be micromechanical surface stress sensors (MSSS), such as microcantilevers and membranes. Preferably, such sensors change in response to one or more molecular or biomolecular interactions”; Abstract: “Systems and techniques for biomechanical analysis are described. Multiple sensors are used to detect different molecules and/or to analyze multiple samples. A property of the sensors changes in response to a target molecule. The change in the property is detected, which may provide a measure of the concentration of the target molecule.”) and a detector for detecting a response of the one or more nanomechanical sensors to the sample and generating one or more signals indicative of the response of the one or more nanomechanical sensors to the sample ([0005]: “The presence of the particular biological molecule may be detected by functionalizing a surface using an appropriate probe molecule, and then detecting a physical change in the functionalized area”. The surface using the probe molecule is the detector; [0064]: “The sensors exhibit a physical change in response to a biological interaction between probe molecules and target molecules. For example, when a target molecule 230 binds to a probe molecule 225, the surface stress of cantilever 210 changes, and cantilever 210 deflects in the -z direction. The amount of deflection provides a measure of the concentration of target molecules in a fluid”; [0004]: “in order to detect a particular antigen, an appropriate antibody may used as a probe molecule”; [0151]: “When target molecules bind specifically to probe molecules attached to a surface of a microcantilever, there is a change in surface stress. The change in surface stress causes the cantilever to bend (FIG. 2)”).
Regarding claim 14, Majumdar teaches the system of claim 13, wherein the response is a bending moment ([0064]: “The sensors exhibit a physical change in response to a biological interaction between probe molecules and target molecules. For example, when a target molecule 230 binds to a probe molecule 225, the surface stress of cantilever 210 changes, and cantilever 210 deflects in the -z direction. The amount of deflection provides a measure of the concentration of target molecules in a fluid”; [0004]: “in order to detect a particular antigen, an appropriate antibody may used as a probe molecule”; [0151]: “When target molecules bind specifically to probe molecules attached to a surface of a microcantilever, there is a change in surface stress. The change in surface stress causes the cantilever to bend (FIG. 2)”).
Regarding claim 15, Majumdar teaches the system of claim 13, wherein the system comprises a first nanomechanical sensor and a second nanomechanical sensor ([0006]: “The present invention provides systems and techniques for detecting different molecules (including biomolecules) using an array of sensors. In preferred embodiments, the sensors may be micromechanical surface stress sensors (MSSS), such as microcantilevers and membranes. Preferably, such sensors change in response to one or more molecular or biomolecular interactions.”. The first and second sensors are included in the array of sensors.), wherein the first nanomechanical sensor and the second nanomechanical sensor are functionalized to detect different target antigens, different target antibodies, or any combination of one or more target antibody and the one or more target antigen in the sample (Abstract: “Systems and techniques for biomechanical analysis are described. Multiple sensors are used to detect different molecules and/or to analyze multiple samples. A property of the sensors changes in response to a target molecule. The change in the property is detected, which may provide a measure of the concentration of the target molecule.”), and wherein the detector detects the response of the first nanomechanical sensor and the response of the second nanomechanical sensor and generates a first signal indicative of the response of the first nanomechanical sensor and a second signal indicative of the response of the second nanomechanical sensor ([0005]: “The presence of the particular biological molecule may be detected by functionalizing a surface using an appropriate probe molecule, and then detecting a physical change in the functionalized area”. The surface using the probe molecule is the detector; [0064]: “The sensors exhibit a physical change in response to a biological interaction between probe molecules and target molecules. For example, when a target molecule 230 binds to a probe molecule 225, the surface stress of cantilever 210 changes, and cantilever 210 deflects in the -z direction. The amount of deflection provides a measure of the concentration of target molecules in a fluid”; [0004]: “in order to detect a particular antigen, an appropriate antibody may used as a probe molecule”; [0151]: “When target molecules bind specifically to probe molecules attached to a surface of a microcantilever, there is a change in surface stress. The change in surface stress causes the cantilever to bend (FIG. 2)”; [0144]: “if an adjacent cantilever is functionalized, then the biological signal can be taken as the difference between the displacement of the functionalized cantilever and the adjacent drifting control cantilever.”. The biological signal is related to each sensor, therefore including a first signal for a first sensor and a second signal for the second sensor.).
Regarding claim 19, Majumdar teaches a method for the detection of a target antigen or a target antibody in a sample ([0080]: “detection methods that reflect the physical differences exhibited by the cantilever due to the change in surface stress (e.g., detection methods that detect the change in angle and/or deflection of the cantilever) may be used.”), the method comprising contacting the nanomechanical sensor according to claim 1 with the sample (Claim 29: “introducing sample fluids or gasses into regions proximate to each of the plurality of sensors comprises introducing sample fluids or gasses into a plurality of individual reservoirs dedicated to individual sensors “) and detecting for a response of the antibody-functionalized microcantilever to the sample ([0005]: “The presence of the particular biological molecule may be detected by functionalizing a surface using an appropriate probe molecule, and then detecting a physical change in the functionalized area”. The surface using the probe molecule is the detector; [0064]: “The sensors exhibit a physical change in response to a biological interaction between probe molecules and target molecules. For example, when a target molecule 230 binds to a probe molecule 225, the surface stress of cantilever 210 changes, and cantilever 210 deflects in the -z direction. The amount of deflection provides a measure of the concentration of target molecules in a fluid”; [0004]: “in order to detect a particular antigen, an appropriate antibody may used as a probe molecule”; [0151]: “When target molecules bind specifically to probe molecules attached to a surface of a microcantilever, there is a change in surface stress. The change in surface stress causes the cantilever to bend (FIG. 2)”; [0144]: “if an adjacent cantilever is functionalized, then the biological signal can be taken as the difference between the displacement of the functionalized cantilever and the adjacent drifting control cantilever.”. The biological signal is related to each sensor, therefore including a first signal for a first sensor and a second signal for the second sensor.).
Regarding claim 21, Majumdar teaches the method of claim 19, wherein the sample comprises less than 10 ng/ml of the target antigen or the target antibody ([0175]: “Because the reactions are limited to the surface, the changes in surface stress are generally independent of the geometry of the cantilever itself. FIG. 23 demonstrates this invariance for fPSA for three different cantilevers of various thickness and length. Note that in order to detect fPSA in the critical regime of 1-10 ng/mL, .gamma. must be measured with an accuracy of .about.1 mJ/m.sup.2.”).
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.
Claims 2 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Majumdar as applied to claim 1 above, and further in view of JP ‘462 (JP 2007504462). Citations to JP 2007504462 will refer to the English Machine Translation that accompanies this Office Action.
Regarding claim 2, Majumdar teaches the sensor of claim 1, wherein the antibody-functionalized microcantilever comprises a microcantilever ([0006]: “The present invention provides systems and techniques for detecting different molecules (including biomolecules) using an array of sensors. In preferred embodiments, the sensors may be micromechanical surface stress sensors (MSSS), such as microcantilevers and membranes. Preferably, such sensors change in response to one or more molecular or biomolecular interactions”), an antibody configured to the target antigen or an antigen configured to bind the target antibody ([0064]: “The sensors exhibit a physical change in response to a biological interaction between probe molecules and target molecules. For example, when a target molecule 230 binds to a probe molecule 225, the surface stress of cantilever 210 changes, and cantilever 210 deflects in the -z direction. The amount of deflection provides a measure of the concentration of target molecules in a fluid”; [0004]: “in order to detect a particular antigen, an appropriate antibody may used as a probe molecule”; [0151]: “When target molecules bind specifically to probe molecules attached to a surface of a microcantilever, there is a change in surface stress. The change in surface stress causes the cantilever to bend (FIG. 2)”).
However, Majumdar does not teach a tether covalently tethering the antibody or the antigen to the microcantilever.
JP ‘462 discloses sensors that use tethers to bind antibodies to a receptor service. Specifically, JP ‘462 teaches a tether covalently tethering the antibody or the antigen to the microcantilever (Page 15: “the candidate artificial receptors of the present invention can be used to find receptor surfaces that bind proteins in a preferred conformation or orientation. Many proteins (eg, antibodies, enzymes, receptors) are stable and / or active in specific environments. A defined receptor surface can be used to create a binding environment that selectively retains or orients proteins for maximum stability and / or activity. In one embodiment, the artificial receptors of the present invention can be used to form a bioactive surface. For example, the receptor surface can be used to specifically bind the active conformation of an antibody or enzyme.”; Page 21: “the support, matrix, or lawn includes a charged site (eg, a first charged site). Suitable charged sites include positively charged sites and negatively charged sites. Suitable positively charged sites (eg, at neutral pH in aqueous compositions) include amines, quaternary ammonium sites, ferrocene and the like. Suitable negatively charged sites (eg, in aqueous compositions, at neutral pH) carboxylates, phenols, phosphates, phosphonates, phosphines substituted by strong electron withdrawing groups (eg, tetrachlorophenol) Acid salts, sulfates, sulfonates, thiocarboxylic acids, hydroxamic acids and the like.”). Majumdar and JP ‘462 are analogous arts as they are both related to sensors that use antibodies for detection of target analytes.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the tether from JP ‘462 into the sensor from Majumdar as it allows the sensor to only bind the specific antibodies required for detection and allows for proper covalent bonding of the antibody or antigen.
Regarding claim 9, the Majumdar/JP ‘462 combination teaches the sensor of claim 2, wherein the microcantilever comprises gold (Majumdar, [0063]: “Cantilever 210 includes a silicon nitride portion 215, and a gold portion 220”).
Regarding claim 10, the Majumdar/JP ‘462 combination teaches the sensor of claim 2, wherein the tether is prepared from a thiocarboxylic acid precursor (JP ‘462, Page 15: “the candidate artificial receptors of the present invention can be used to find receptor surfaces that bind proteins in a preferred conformation or orientation. Many proteins (eg, antibodies, enzymes, receptors) are stable and / or active in specific environments. A defined receptor surface can be used to create a binding environment that selectively retains or orients proteins for maximum stability and / or activity. In one embodiment, the artificial receptors of the present invention can be used to form a bioactive surface. For example, the receptor surface can be used to specifically bind the active conformation of an antibody or enzyme.”; Page 21: “the support, matrix, or lawn includes a charged site (eg, a first charged site). Suitable charged sites include positively charged sites and negatively charged sites. Suitable positively charged sites (eg, at neutral pH in aqueous compositions) include amines, quaternary ammonium sites, ferrocene and the like. Suitable negatively charged sites (eg, in aqueous compositions, at neutral pH) carboxylates, phenols, phosphates, phosphonates, phosphines substituted by strong electron withdrawing groups (eg, tetrachlorophenol) Acid salts, sulfates, sulfonates, thiocarboxylic acids, hydroxamic acids and the like.”).
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over the Majumdar/JP ‘462 combination as applied to claim 2 above, and further in view of Tamayo (US 20200072829).
Regarding claim 3, the Majumdar/JP ‘462 combination teaches the sensor of claim 2.
However, the Majumdar/JP ‘462 combination is silent on the effective surface density.
Tamayo teaches a system for biodetection applications. Specifically, Tamayo teaches wherein the microcantilever has an effective surface density of tethered antibodies or antigens thereon ([0017]: “The study showed that the performance of the assay depends critically on both the antibody surface density and the blocking strategies. It was found that optimal conditions involve antibody surface densities near but below saturation”). Majumdar and Tamayo are analogous art as they are both microcantilevers used for detection of antigens and antibodies.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the surface density from Tamayo into the device from the Majumdar/JP ‘462 combination as the combination is silent on the effective surface density, and Tamayo discloses suitable surface density in an analogous device.
Regarding claim 8, the Majumdar/JP ‘462 combination teaches the sensor of claim 2.
However, the Majumdar/JP ‘462 combination does not teach wherein the antibody or the antigen is conjugated to the tether by EDC-NHS chemistry.
Tamayo teaches wherein the antibody or the antigen is conjugated to the tether by EDC-NHS chemistry ([0131]: “Before surface functionalization, the cantilever arrays were cleaned with piranha solution (3H.sub.2SO.sub.4:1H.sub.2O.sub.2) (it should be noted that piranha solution is extremely corrosive and reactive as well as potentially explosive) for 15 minutes at room temperature (RT). The cantilevers were rinsed three times with Milli-Q water and dried under a nitrogen stream. The cantilevers were immersed in a 0.2% solution of (3-glycidyloxypropyl)trimethoxysilane in dry toluene overnight at room temperature. After that, the samples were washed with toluene, Milli-Q water and dried under N.sub.2. A solution of 100 mM NTA in 50 mM carbonate buffer at pH 9.5 was prepared and the cantilevers were incubated overnight at 25° C. under gentle stirring. The cantilevers were then rinsed with 50 mM carbonate buffer at pH 9.5, Milli-Q water and dried under N.sub.2. The carboxyl groups on the cantilever surface were activated by immersion in a mixed solution of 100 mM EDC and 150 mM sulfo-NHS, both dissolved in 10 mM MES at pH 5.5. The cantilevers were incubated for 45 minutes at 37° C. under gentle stirring. The samples were rinsed well with 10 mM MES”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the connection of the antibody or antigen to the tether from Tamayo into the Majumdar/JP ‘462 combination as the combination is silent on the method of connection, and Tamayo teaches a suitable connection in an analogous device.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over the Majumdar/JP ‘462 combination as applied to claim 2 above, and further in view of Hwang (US 20110212511).
Regarding claim 4, the Majumdar/JP ‘462combination teaches the sensor of claim 2, wherein the microcantilever is functionalized (Majumdar, [0061]: “Each cantilever 110 is associated with a reservoir 113 that may hold fluids, where the fluids may include fluids for functionalizing the cantilever, sample fluids for molecular or biological analysis, and fluids used for rinsing”).
However, the Majumdar/JP ‘462 combination is silent on what solution the microcantilever is functionalized with.
Hwang discloses a system for detecting biomolecules with high sensitivity using a microcantilever. Specifically, Hwang discloses functionalizing the microcantilever with an antibody precursor solution having an antibody concentration of 10 µg/ml - 100 µg/ml or an antigen precursor solution having an antigen concentration of 10 µg/ml - 100 µg/ml ([0041]: “To immobilize a monoclonal antibody against prostate specific antigen, the micro-cantilever having the SAM of calixcrown formed thereon is left in 10 .mu.g/mL of aqueous monoclonal antibody against prostate specific antigen/phosphate buffered saline (PBS) solution at room temperature for 1 hour.”). Majumdar and Hwang are analogous arts as they are both related to sensors used to detect biomolecules using a microcantilever.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the precursor from Hwang into the Majumdar/JP ‘462 combination as the combination is silent on the solution used to functionalize the microcantilever, and Hwang discloses a suitable precursor in an analogous device.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over the Majumdar/JP ‘462 combination as applied to claim 2 above, and further in view of Tabib-Azar (WO 2021081476).
Regarding claim 5, the Majumdar/JP ‘462 combination teaches the sensor of claim 2.
However, the Majumdar/JP ‘462 combination is silent on the specific antibodies or antigens being detected.
Tabib-Azar discloses pathogen sensors. Specifically, Tabib-Azar teaches wherein target antigen is a pathogenic antigen or the target antibody is indicative of an infection (Page 10, lines 19-22: “a colorimetric pathogen sensor 100 as disclosed herein can comprise a substrate 110 and an molecular recognition group (e.g. aptamer) 120 coupled to the substrate 110. The molecular recognition group 120 can be operable to selectively bind to a target pathogen 130”; Page 1, lines 22-23: “After 7-14 days of infection, the body also produces antibodies that can be detected to infer the infection”; Page 11, lines 3-4: “Viral biomolecules can be any chemical entity which is directly or indirectly related to the presence of viruses by indicating a current or previous infection with the virus”; Page 12, line 15: “the aptamers can be selective for SARS-CoV-2”). Majumdar and Tabib-Azar are analogous arts as they are both related to sensors for detecting antibodies and antigens.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the specific antibody being detected from Tabib-Azar into the Majumdar/JP ‘462 combination as the combination is silent on the specific antibodies it detects, and Tabib-Azar discloses suitable antibodies in an analogous device.
Regarding claim 6, the Majumdar/JP ‘462/Tabib-Azar combination teaches the sensor of claim 5, wherein the pathogenic antigen is a SARS-CoV-2 protein (Tabib-Azar, Page 12, line 15: “the aptamers can be selective for SARS-CoV-2”).
Regarding claim 7, , the Majumdar /JP ‘462/Tabib-Azar combination teaches the sensor of claim 5, wherein the infection is SARS-CoV-2 infection (Tabib-Azar, Page 12, line 15: “the aptamers can be selective for SARS-CoV-2”).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Majumdar as applied to claim 1 above, and further in view of Shekhawat (US 7759924).
Regarding claim 11, Majumdar teaches the sensor of claim 1.
However, Majumdar does not teach wherein the sensor comprises a field-effect transistor.
Shekhawat discloses a microcantilever for detecting antibodies. Specifically, Shekhawat teaches wherein the sensor comprises a field-effect transistor (Column 15, lines 33-38: “an electronic transduction paradigm includes two-dimensional microcantilever arrays with geometrically configured Bi-MOSFETs (metal-oxide semiconductor field-effect transistors) embedded in a high stress region of one or more microcantilevers, optimized or improved after finite-element analysis simulations”). Majumdar and Shekhawat are analogous arts as they are both related to microcantilevers for detecting antibodies.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the field-effect transistor from Shekhawat into the device from Majumdar as it allows the sensor to be optimized for detection, providing an improved analysis.
Regarding claim 12, the Majumdar /Shekhawat combination teaches the sensor of claim 11, wherein the field effect transistor is a metal-oxide-semiconductor field-effect transistor (MOSFET) (Shekhawat, Column 15, lines 33-38: “an electronic transduction paradigm includes two-dimensional microcantilever arrays with geometrically configured Bi-MOSFETs (metal-oxide semiconductor field-effect transistors) embedded in a high stress region of one or more microcantilevers, optimized or improved after finite-element analysis simulations”).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Majumdar as applied to claim 13 above, and further in view of Daniels (US 12031982).
Regarding claim 16, Majumdar teaches the system of claim 13.
However, Majumdar does not teach the system further comprising a computing platform having a communication interface that receives one or more signals from the detector, and a computer in communication with the communication interface, wherein the computer comprises a computer processor and a computer readable medium comprising machine-executable code that, upon execution by the computer processor, implements a method for determining the response of the one or more nanomechanical sensors to the sample.
Daniels discloses a system using exhaled breath condensate for testing for a biomarker of COVID-19. Specifically, Daniels teaches the system further comprising a computing platform (Column 28, line 51-Column 29, line 12: “In accordance with another aspect of the invention, an apparatus, comprises: at least one processor; and at least one memory including computer program code, the at least one memory and the computer program code configured to, with the at least one processor, cause the apparatus to perform at least the following: detecting one or more biometric parameters using a droplet harvesting structure for converting breath vapor to a fluid droplet for forming a fluid sample and a testing system having a biomarker testing zone for receiving the fluid sample and detecting the biometric parameter, where the biometric parameters are biomarkers dependent on at least one physiological change to a patient in response to a concerning condition such as a virus infection; receiving the one or more biometric parameters and applying probabilistic analysis to determine if at least one physiological change threshold has been exceeded dependent on the probabilistic analysis of the one or more biometric parameters; and activating an action depending on the determined exceeded said at least one physiological change.”) having a communication interface that receives the one or more signals from the detector, and a computer in communication with the communication interface (Column 24, lines 33-38: “a testing system for receiving the fluid biological sample from the breath droplet harvester and testing for a target analyte, and a wireless communication electronic circuit for detecting a result of the testing for the target analyte and communicating the result to a wireless receiver”), wherein the computer comprises a computer processor and a computer readable medium comprising machine-executable code that, upon execution by the computer processor (Column 4, lines 51-52: “an apparatus, comprises: at least one processor”), implements a method for determining the response of the one or more nanomechanical sensors to the sample (Column 4, lines 38-41: “a computer program product comprising a computer-readable medium bearing computer program code embodied therein for use with a computer, the computer program code comprising: code for: detecting one or more biometric parameters”). Majumdar and Daniels are analogous arts as they are both related to sensors that test samples for antibodies.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the computer platform from Daniels into the system from Majumdar as it allows the system to analyze and compute the results on a separate computer device, which has more computing capabilities and analysis processes, which can lead to a more accurate and comprehensive analysis.
Regarding claim 17, Majumdar teaches the system of claim 13.
However, Majumdar is silent on where the sample for the sensor is gathered.
Daniels teaches the system further comprising a breath collector that is operably connected to the sensor (Abstract: “The droplet harvesting structure may include at least one of a hydrophobic field for receiving the breath vapor and forming the fluid droplet from the received breath vapor and hydrophilic channels for receiving the fluid droplet and channeling the fluid droplet towards the testing system.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the breath collector from Daniels into the system from Majumdar as Majumdar is silent on where the sample is received from, and Daniels provides a suitable sample collector in an analogous device.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Majumdar as applied to claim 19 above, and further in view of Melker (US 20090005270).
Regarding claim 20, Majumdar teaches the method of claim 19.
However, Majumdar is silent on how long the response is detected within.
Melker discloses a sensor for detecting antibodies using a microcantilever. Specifically, Melker teaches wherein the response to the target antigen or the target antibody is detected within 5 minutes of contacting the nanomechanical sensor with the sample ([0110]: “The technology is very portable (small and low power consumption), relatively fast in response time (less than 1 minute)”). Majumdar and Melker are analogous arts as they are both related to microcantilevers used to detect antibodies.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the detection time from Melker into the system from Majumdar as Majumdar is silent on the detection time, and Melker discloses a suitable detection time in an analogous device.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant has amended the claims to overcome the 112(b) rejections, however the amendments have introduced new claim objections and 112(b) rejections.
Applicant’s arguments with respect to claims 1-17 and 19-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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