DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 26, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on October 26, 2023 are accepted.
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.
Claim 19 is 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.
Claim 19 recites the limitation “the antibodies”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 11-14 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freire (WO 2019/173220 A1) (“Freire”).
Regarding claim 11, Freire discloses A device comprising (Abstract and entire document):
an electrically conductive layer having attached thereto one or more binding moieties configured to bind one or more biomarkers of a biological oral fluid, wherein binding of the one or more biomarkers to the binding moieties causes a change in one or more electrical characteristics of the conductive layer (attaching a binding moiety to an electrically conductive surface, wherein said binding moiety interacts specifically with one or more biomarkers in the biological fluid; paragraph [0014] and (system or device for detecting the presence of one or more biomarkers using binding moieties in a biological fluid comprising an electrically conductive layer; paragraph [0015]);
one or more base layers positioned in contact with the electrically conductive layer, wherein the one or more base layers comprise at least one of ceramic, silica, polymer, or plastic (which may be provided on a non-biodegradable support such as a non-biodegradable polymer, plastic, titanium, composite resin or ceramic; paragraph [0015]);
and a logic circuit coupled to an antenna, the logic circuit coupled to the electrically conductive layer, wherein the logic circuit is configured to, in response to the change in one or more electrical characteristics of the electrically conductive layer caused by the binding of the one or more biomarkers, transmit a signal, via the antenna, to an external device, and wherein the signal is indicative of the change (wherein binding of one or more biomarkers to said binding moieties generates a change in one or more electronic characteristics of said conductive layer; and further comprising one or more base layers in contact with said conductive surface, and an antenna, whereby said change in one or more electronic characteristics related to the binding of said one or more biomarkers may be communicated, preferably wirelessly, to an external device; paragraph [0015]).
Regarding claim 12, Freire discloses The device of claim 11, wherein the biological oral fluid is at least one of saliva, crevicular fluid, lymphatic fluid, blood, interstitial fluid, spinal fluid, dental plaque, and oral sweat (within the systems as contemplated herein, said biological fluid may be saliva, crevicular fluid, lymphatic fluid, spinal fluid or oral sweat; paragraph [0015]).
Regarding claim 13, Freire discloses The device of claim 11, wherein the one or more biomarkers comprise one or more inflammatory molecules, a viral metabolite, a bacterial membrane component, a bacterial cell wall component, a virus, a nonviral pathogen, a polysaccharide, a nucleic acid, or any combination thereof (biomarkers contemplated herein may comprise one or more of an inflammatory molecule, a cytokine, a bacterial metabolite, a bacterial membrane component, a bacterial cell wall component, a virus, a nonviral pathogen, a polysaccharide, a lipid or a nucleic acid, or any combination thereof; paragraph [0016]).
Regarding claim 14, Freire discloses The device of claim 11, wherein the signal indicates a presence and/or concentration of the one or more biomarkers (wherein binding of one or more biomarkers to said binding moieties generates a change in one or more electronic characteristics of said conductive layer; paragraph [0015]).
Regarding claim 16, Freire discloses The device of claim 11, wherein the external device is configured to receive and analyze the signal indicative of the change in the one or more electrical characteristics of the conductive layer (said external device may comprise a processor and a memory configured to retain and/or analyze said signal from said change in one or more electronic characteristic of said conductive layer; paragraph [0016]).
Regarding claim 17, Freire discloses The device of claim 16, wherein analyzing the signal includes identifying a normal or an abnormal medical condition (identifying the presence of a disease or condition associated with a disease or for monitoring the progression of a disease or a therapy for a disease in a subject; paragraph [0085]).
Regarding claim 18, Freire discloses A method for detecting a condition or disorders associated with oral and systemic health in a subject, the method comprising (identifying the presence of a disease or condition associated with a disease or for monitoring the progression of a disease or a therapy for a disease in a subject; paragraph [0085]):
detecting altered level of at least one biomarker related to monitoring of homeostasis of diagnostic infectious diseases and immunological changes by detecting binding of the one or more biomarkers to one or more binding moieties that causes a change in at least one electrical characteristic of an electrically conductive layer (biomarkers may include but are not limited to immune or inflammatory biomarkers such as inflammatory c-reactive protein (CRP), microbiome-derived biomarkers such as lipopolysaccharides (LPS), and metabolically derived biomarkers or hormones, such as cortisol hormone; paragraph [0160] and (biomarkers may include but are not limited to immune or inflammatory biomarkers such as inflammatory c-reactive protein (CRP), microbiome-derived biomarkers such as lipopolysaccharides (LPS), and metabolically derived biomarkers or hormones, such as cortisol hormone; paragraph [0160]), and
in response the change in the at least one electrical characteristic caused by the binding of the one or more biomarkers to the one or more binding moieties, transmitting a signal indicating the change (said change in one or more electronic characteristics related to the binding of said one or more biomarkers may be communicated, preferably wirelessly, to an external device; paragraph [0015]).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 15 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Freire (WO 2019/173220 A1) (“Freire”) in view of Kuo (US 6623698 B2) (“Kuo”).
Regarding claim 15, Freire discloses The device of claim 11, Freire fails to disclose further comprising a bristle attachment detachably coupled to one of the electrically conductive layers and the one or more base layers.
However, in the same field of endeavor, Kuo teaches further comprising a bristle attachment detachably coupled to one of the electrically conductive layers and the one or more base layers (a brush head with a channel cover and a snap-on bracket for holding bristle elements; column 7, lines 62-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Freire to include further comprising a bristle attachment detachably coupled to one of the electrically conductive layers and the one or more base layers as taught by Kuo to retain saliva for testing (Col. 9 lines 10-31).
Regarding claim 19, Freire discloses The method of claim 18 Freire further discloses processing a cellular and molecular content of the oral fluids or the orally derived molecules to detect fixation, hybridization, and stabilization; conjugating one or more binding moieties by detecting one of the antibodies, a binding fragment of the antibody, and a nucleic acid (system or device for detecting the presence of one or more biomarkers in a biological fluid comprising an electrically conductive layer; paragraph [0015] and binding of a protein, antibody, peptide, aptamer, or binding fragment thereof to graphene or graphene oxide can be covalent or non-covalent. These can be coupled to the graphene or graphene oxide through disulfide, maleimide chemistry, NHS chemistry using N-hydroxysuccinimide esters (binding using tags or labels); paragraph [0146]),
Freire fails to disclose further comprising applying oral fluids or orally derived molecules to a device;
capturing the oral fluids or the orally derived molecules;
wherein detecting the binding includes detecting tags or labels, and wherein detecting labels is using an optical sensor.
However, in the same field of endeavor, Kuo teaches further comprising applying oral fluids or orally derived molecules to a device (saliva is drawn into the open channel by its capillary action, facilitated by a partial vacuum caused by the vibration of the channel walls; column 6, lines 65-67);
capturing the oral fluids or the orally derived molecules (the brush head stimulates saliva production and collection in the test channel; column 6, lines 34-36);
wherein detecting the binding includes detecting tags or labels, and wherein detecting labels is using an optical sensor (after a predetermined mixing time period, the sensors take readings on the optical density and/or the electrical current level which reflect the concentrations of targeted analytes of the saliva sample; column 7, lines 14-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Freire to include further comprising applying oral fluids or orally derived molecules to a device; capturing the oral fluids or the orally derived molecules; wherein detecting the binding includes detecting tags or labels, and wherein detecting labels is using an optical sensor as taught by Kuo to retain saliva for testing (Col. 9 lines 10-31).
Regarding claim 20, Freire discloses The method of claim 18, Freire further discloses wherein the housing includes attachment to a diagnostic that is coupled with wither an analog layer or electrically conductive layer to isolate and detect nucleic acid, proteins, and metabolites from oral fluids, further comprising at least one of detecting the level of one or more biomarkers from oral fluids to infer immune health or dysbiosis (wherein binding of one or more biomarkers to said binding moieties generates a change in one or more electronic characteristics of said conductive layer, said change in one or more electronic characteristics related to the binding of said one or more biomarkers may be communicated, preferably wirelessly, to an external device; paragraph [0015] and (high-throughput screening techniques applied to saliva may provide identification and quantification of a host and microbial DNA, RNA, proteins, and metabolites.; paragraph [0101] and (increased bacterial lipopolysaccharide (LPS) may be found in chronic inflammatory diseases that are modified by microbiome dysbiosis. Furthermore, monitoring of saliva may provide detection of important health information related to inflammation, a microbiome of the host body, and metabolism of the host body; paragraph [0101]),
Freire fails to disclose calculating the levels of subject to provide individualized data in a cross-sectional basis, comparing to previous testing bassline to provide a data curve a longitudinal basis, providing a score system of health, risk for disease, and disease to facilitate better compression of complex molecular data, and providing information on biomarkers to detect the condition or disorder in the subject.
However, in the same field of endeavor, Kuo teaches calculating the levels of subject to provide individualized data in a cross-sectional basis, comparing to previous testing bassline to provide a data curve a longitudinal basis, providing a score system of health, risk for disease, and disease to facilitate better compression of complex molecular data, and providing information on biomarkers to detect the condition or disorder in the subject (an algorithm in the microprocessor recognizes the peak and compares the maximum value with an established threshold value. The measured data also is displayed on an LED board to indicate normal data trend and peaks of optical density. If the peak of the displayed data is out of normal range, an acoustic or visual indicator signal is activated to alert the user; column 10, lines 7-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Freire to include calculating the levels of subject to provide individualized data in a cross-sectional basis, comparing to previous testing bassline to provide a data curve a longitudinal basis, providing a score system of health, risk for disease, and disease to facilitate better compression of complex molecular data, and providing information on biomarkers to detect the condition or disorder in the subject as taught by Kuo to retain saliva for testing (Col. 9 lines 10-31).
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kuo (US 6623698 B2) (“Kuo”) in view of Freire (WO 2019/173220 A1) (“Freire”) in further view of Schwarz, U. et al. (US 2003/0129673 A1) (“Schwarz”).
Regarding claim 1, Kuo discloses A biometric oral monitoring system comprising (Abstract and entire document):
an oral hygiene device including a display (a display unit for the microprocessor is attached to the handle; column 6, lines 58-59);
a multimodal sensing diagnostic system integrally incorporated into the oral hygiene device and configured to capture and evaluate at least one biomarker relative to normal and abnormal levels in a human, the multimodal sensing diagnostic system including (the oral device is configured as a saliva-monitoring, biosensor electrical toothbrush which has a handle and a brush head, where the device measures for disease status, pregnancy, or other conditions using reagents (evaluate at least one biomarker); column 6, lines 45-46):
a logic circuit communicatively coupled to the electrically conductive surface and the display, wherein the logic circuit is configured to receive the signal from the electrically conductive surface and display an indication on the display based on the signal (the microprocessor inside the toothbrush handle compares newly measured data against established trend and threshold values to signal abnormality. The display unit is capable of providing trend data and sending acoustical or visual warning signals; column 6, lines 17-21).
Kuo fails to disclose an absorbing layer configured to capture analytes of a biological oral fluid,
a multimodal sensing layer configured to detect molecular cues,
a recognition moiety configured to bind to one or more analytes, wherein the binding moiety interacts with at least one biomarker present in the biological fluid to detect the at least one biomarker,
an electrically conductive surface electrically coupled to the recognition moiety and configured to generate a signal in response to binding of the binding moiety and the at least one biomarker, wherein the signal is indicative of a parameter value of the at least one biomarker, and
However, in the same field of endeavor, Freire teaches a multimodal sensing layer configured to detect molecular cues (a system or device for detecting the presence of one or more biomarkers in a biological fluid comprising an electrically conductive layer; paragraph [0015]),
a recognition moiety configured to bind to one or more analytes, wherein the binding moiety interacts with at least one biomarker present in the biological fluid to detect the at least one biomarker (attaching a binding moiety to an electrically conductive surface, wherein said binding moiety interacts specifically with one or more biomarkers in the biological fluid; paragraph [0014]),
an electrically conductive surface electrically coupled to the recognition moiety and configured to generate a signal in response to binding of the binding moiety and the at least one biomarker, wherein the signal is indicative of a parameter value of the at least one biomarker (attaching a binding moiety to an electrically conductive surface, wherein said binding moiety interacts specifically with one or more biomarkers in the biological fluid, and wherein upon binding a detectable signal is generated, which corresponds to an amount and/or presence of the biomarker in a biological fluid such as saliva; paragraph [0014] and multiple devices 300 can be inserted into the host's mouth for detection of multiple of the same parameters; paragraph [0152]), and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system method as taught by Freire to include a multimodal sensing layer configured to detect molecular cues, a recognition moiety configured to bind to one or more analytes, wherein the binding moiety interacts with at least one biomarker present in the biological fluid to detect the at least one biomarker, an electrically conductive surface electrically coupled to the recognition moiety and configured to generate a signal in response to binding of the binding moiety and the at least one biomarker, wherein the signal is indicative of a parameter value of the at least one biomarker as taught by Freire to improve patient care with useful real-time data collection (Page 4, Summary).
Kuo as modified fails to disclose an absorbing layer configured to capture analytes of a biological oral fluid,
However, in the same field of endeavor, Schwarz teaches an absorbing layer configured to capture analytes of a biological oral fluid (the liquid to be tested flows on the basis of capillary action from the collecting membrane into a porous reaction cushion where the reaction between the analyte and the marked antigen or antibody takes place, the test strip itself is designed so that several analytes can be determined at the same time; paragraph [0013]),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Kuo as modified to include an absorbing layer configured to capture analytes of a biological oral fluid as taught by Schwarz to absorb analyte for testing ([0013], “The excess liquid is absorbed into an adsorption membrane. The test strip itself is preferably designed so that not only one, but several analytes, can be determined at the same time, since simultaneous dependency on various addictive substances occurs relatively frequently.”).
Regarding claim 2, Kuo as modified discloses The biometric oral monitoring system of claim 1, Kuo further disclose wherein the multimodal sensing layer is one of antigenic, immunological, infectious agent-, and molecular-based (an optical sensor, a pH sensor, a colormetric sensor or an elaborated integrated sensor system can be used in the test channel for fertility, pregnancy, labor onset, alcohol content, glucose concentration, or HIV indicators measurements; column 6, lines 40-42; column 16, lines 48-50).
Regarding claim 3, Kuo as modified discloses The biometric oral monitoring system of claim 1, Kuo further disclose wherein the biological oral fluid is one of saliva, crevicular fluid, lymphatic fluid, blood, interstitial fluid, spinal fluid, dental plaque, and oral sweat (a saliva-monitoring oral device which is inserted into the mouth to collect and test saliva; column 6, lines 32-34).
Regarding claim 4, Kuo as modified discloses The biometric oral monitoring system of claim 1, Kuo fails to disclose wherein the at least one biomarker comprises at least one of a host immune molecule, an immunoglobulin, a virus a nonviral pathogen, a bacterial metabolite, a bacterial membrane component, a bacterial cell wall component, a polysaccharide, and a nucleic acid.
However, in the same field of endeavor, Freire teaches wherein the at least one biomarker comprises at least one of a host immune molecule, an immunoglobulin, a virus a nonviral pathogen, a bacterial metabolite, a bacterial membrane component, a bacterial cell wall component, a polysaccharide, and a nucleic acid (the biomarker comprises one or more of an inflammatory molecule, a cytokine, a bacterial metabolite, a bacterial membrane component, a bacterial cell wall component, a host cell, DNA strands from host cells, immune cell wall, a virus, a nonviral pathogen, a polysaccharide, a lipid, or a nucleic acid, or any combination thereof; paragraph [0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system method as taught by Kuo to include wherein the at least one biomarker comprises at least one of a host immune molecule, an immunoglobulin, a virus a nonviral pathogen, a bacterial metabolite, a bacterial membrane component, a bacterial cell wall component, a polysaccharide, and a nucleic acid as taught by Freire to improve patient care with useful real-time data collection (Page 4, Summary).
Regarding claim 5, Kuo as modified discloses The biometric oral monitoring system of claim 1, Kuo fails to disclose wherein the electrically conductive surface detects binding of the binding moiety and the at least one biomarker by detecting a change in at least one of an electrical current, an electrical voltage, and an electrical impedance.
However, in the same field of endeavor, Freire teaches wherein the electrically conductive surface detects binding of the binding moiety and the at least one biomarker by detecting a change in at least one of an electrical current, an electrical voltage, and an electrical impedance (for example, the spatially resolvable electronic signal may manifest as a change in impedance or capacitance at the location of the bound biomarker; paragraph [0119]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system method as taught by Kuo to include wherein the electrically conductive surface detects binding of the binding moiety and the at least one biomarker by detecting a change in at least one of an electrical current, an electrical voltage, and an electrical impedance as taught by Freire to improve patient care with useful real-time data collection (Page 4, Summary).
Regarding claim 6, Kuo as modified discloses The biometric oral monitoring system of claim 1, Kuo fails to disclose wherein the oral hygiene device comprises one of plastic, polymer, titanium, and ceramic material.
However, in the same field of endeavor, Freire teaches wherein the oral hygiene device comprises one of plastic, polymer, titanium, and ceramic material (a system or device for detecting the presence of one or more biomarkers may be provided on a non-biodegradable support such as a non-biodegradable polymer, titanium, metal, composite resin, plastic or ceramic; paragraph [0015]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system method as taught by Kuo to include wherein the oral hygiene device comprises one of plastic, polymer, titanium, and ceramic material as taught by Freire to improve patient care with useful real-time data collection (Page 4, Summary).
Regarding claim 7, Kuo as modified discloses The biometric oral monitoring system of claim 6, Kuo further disclose wherein the oral hygiene device is shaped for use in an oral cavity (oral device which is inserted into the mouth to collect and test saliva; column 6, lines 33-34).
Regarding claim 8, Kuo as modified discloses The biometric oral monitoring system of claim 7, Kuo further disclose wherein the oral hygiene device is shaped for use in one of buccal regions, a sublingual region, a palatal region, and a vestibular region of the oral cavity (when placed in contact with the tongue or cheek, the vibrating channel walls stimulate the secretion and accumulation of saliva under the tongue; column 6, lines 62-65).
Regarding claim 9, Kuo as modified discloses The biometric oral monitoring system of claim 1, Kuo fails to disclose wherein the logic circuit is configured to transmit a signal indicating a presence and/or concentration of the at least one biomarker to an external device.
However, in the same field of endeavor, Freire teaches wherein the logic circuit is configured to transmit a signal indicating a presence and/or concentration of the at least one biomarker to an external device (change in one or more electronic characteristics related to the binding of said one or more biomarkers may be communicated, preferably wirelessly, to an external device; paragraph [0015]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system method as taught by Kuo to include wherein the logic circuit is configured to transmit a signal indicating a presence and/or concentration of the at least one biomarker to an external device as taught by Freire to improve patient care with useful real-time data collection (Page 4, Summary).
Regarding claim 10, Kuo as modified discloses The biometric oral monitoring system of claim 6, Kuo further discloses wherein the biological oral fluid originates in tissue of the oral cavity (a saliva-monitoring oral device which is inserted into the mouth to collect and test saliva; column 6, lines 32-34).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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/JOSEPH A TOMBERS/Examiner, Art Unit 3791