CTFR 18/002,995 CTFR 84652 DETAILED ACTION Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1-13, 21, 22, 25, 26, 29, and 30 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Chan et al. (“Fast in vivo detection of myocardial norepinephrine levels in the beating porcine heart”) . As to claim 1, Chan teaches a method for detecting a biochemical compound (Title) comprising the steps of: inserting one or more electrodes in one or more locations selected from the group consisting of: a tissue, an organ, a neural structure, a lymphatic vessel, a lymphatic node, an extravascular fluid compartment, and a peripheral blood vessel (Fig. 4 - electrode sites); applying a voltage scan to the electrode (H1091 - FSCV applied); and detecting a current indicative of the concentration of the compound (Fig. 4 - C). As to claim 2, Chan teaches placement into the myocardium of a heart (Fig. 4 - A; H1092 - placement of electrodes in the myocardium). As to claim 3, Chan teaches the insertion via epicardial or vascular access (H1098 - vascular insertion route). As to claim 4, Chan teaches the compound is at least one catecholamine selected from the group consisting of norepinephrine and epinephrine (Title). As to claim 5, Chan teaches the electrode is an electrode selected from the group consisting of wire electrodes, microwire electrodes, needle electrodes, plunge electrodes, penetrating electrodes, patch electrodes, single shank electrodes, 2D shank electrodes, 3D shank electrodes, and multi-electrode arrays (H1092 - wire electrodes). As to claim 6, Chan teaches the voltage scan is a fast scanning cyclic voltammetry (FSCV) voltage scan (H1091 - FSCV applied). As to claim 7, Chan teaches the FSCV voltage scan comprises a waveform selected from the group consisting of: a sawtooth pattern and sinusoidal pattern (H1093 - command potential for FSCV was a sawtooth waveform). As to claim 8, Chan teaches detecting the oxidation current of the compound (H1093 - oxidation currents were determined) As to claim 9, Chan teaches constructing a voltammogram from the detected current, thereby identifying the compound (H1093 - Norepinephrine specificity … determined by the shape of the recorded voltammogram). As to claim 10, Chan teaches quantifying the concentration of the compound by plotting the peak current on a calibration curve (Fig. 3 - calibrated on a calibration curve to provide interstitial norepinephrine changes). As to claim 11, Chan teaches the organ is a heart, and the one or more electrodes are placed in one or more locations selected from the group consisting of: a coronary sinus of the heart, a great vein of the heart, vena cava, left ventricle, aorta, right ventricle, right atria, left atria, pulmonary veins, pulmonary artery, stellate ganglia, dorsal root ganglia, epicardial fat pad, and pericardial fat pad (Fig. 4 - left ventricle). As to claim 12, Chan teaches the concentration of the biochemical compound is assessed in response to one or more cardiac stressors selected from the group consisting of: a change in cardiac preload, a change in cardiac afterload, a change in sympathetic efferent inputs to the heart, a change in parasympathetic efferent inputs to the heart, a change in autonomic control of the heart, a change in cardiac afferent input, and cardiac pacing (H1094 - cardiac stressors; H1092 - provide specific readouts of individual responses to cardiac stressors). As to claim 13, Chan teaches plurality of electrodes are placed at a plurality of locations within and around a heart to assess regional differences in the abundance of the biochemical compound (Fig. 4 - electrode sites red, blue, green, and black). As to claim 21, Chan teaches a biochemical compound detection device (H1092 - instrumentation), comprising: a controller, comprising a voltage clamp circuit (H1096 - voltage clamp circuit) and signal acquisition (H1092 - signal acquired) and amplification device (H1097 - amplifier); a reference electrode communicatively connected to the controller (H1093 - reference electrodes); and a one or more measurement electrodes communicatively connected to the controller (H1093 - wire electrodes); wherein the controller is configured to measure a reference potential across the reference and ground electrodes and voltage clamp of the one or more measurement electrodes relative to the reference potential (H1096 - stable and accurate reference potential for the voltage clamp circuitry) with a defined sawtooth, sinusoidal or step command potential (H1093 - sawtooth waveform), and to measure the current passing through the one or more measurement electrodes over time (H1093 - current amplitude); and wherein the measurement electrodes are configured to measure the presence and concentration of one or more biochemical compounds (Title - norepinephrine). As to claim 22, Chan teaches a ground electrode (H1093 - ground electrodes), wherein the controller is configured to measure an electric potential between the reference electrode and the ground electrode (H1092 - common ground/reference circuit). As to claim 25, Chan teaches at least one of the electrodes selected from the group consisting of the measurement electrode and the reference electrode are made of platinum (H1092 - Platinum wire electrodes). As to claim 26, Chan teaches the reference electrode and one or more measurement electrodes are selected from the group consisting of wire electrodes, microwire electrodes, needle electrodes, plunge electrodes, penetrating electrodes, patch electrodes, single shank electrodes, 2D shank electrodes, 3D shank electrodes, and multi-electrode arrays (H1092 - wire electrodes). As to claim 29, Chan teaches a voltage clamp, configured to maintain a substantially constant voltage across two or more electrodes (H1097 - reliable voltage clamp) As to claim 30, Chan teaches a biochemical compound detection device (H1092 - instrumentation), comprising. a controller, comprising a voltage clamp amplifier H1096 - voltage clamp circuit); a reference electrode communicatively connected to the controller (H1093 - reference electrodes); a ground electrode communicatively connected to the controller (H1093 - ground electrodes); and one or more sensing electrodes communicatively connected to the controller (H1093 - wire electrodes), each of the one or more sensing electrodes being voltage clamped to a template of positive and negative voltage steps (Fig. 1 - B); wherein the controller is configured to measure an electric potential across the reference electrode, the ground electrode, and to apply a command potential relative to the reference potential through a voltage clamp to one or more sensing electrodes (H1096 - stable and accurate reference potential for the voltage clamp circuitry), and to measure the current passing through one or more sensing electrodes over time (H1093 - current amplitude); and wherein one or more sensing electrodes are configured to measure the presence and concentration of one or more biochemical compounds (Title - norepinephrine) Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 14-16, 18, 20, 23, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al. (“Fast in vivo detection of myocardial norepinephrine levels in the beating porcine heart”) in view of Richardson-Burns et al. (US 2015/0369771) . As to claim 14, Chan teaches a method for detecting a biochemical compound (Title) comprising the steps of: inserting one or more electrodes in one or more locations selected from the group consisting of: a tissue, an organ, a neural structure, a lymphatic vessel, a lymphatic node, an extravascular fluid compartment, and a peripheral blood vessel (Fig. 4 - electrode sites). Chan fails to teach that the at least one electrode comprises a receptor molecule that specifically binds the biochemical compound; and detecting a change in the capacitance of the electrode thereby indicating the presence of the biochemical compound. Richard-Burns teaches bioelectrodes for measuring analyte levels ([0186]) via measurement of various electrode parameters including capacitance ([0068]) and teaches the functionalization of such biological components such as receptors ([0042]) which allows for the binding of the biological compound to the receptor for measurement ([0066]). Accordingly, it would have been obvious to modify Chan with Richard-Burns to utilize receptor molecules for the detection of specific, targeted analytes, and also utilize the measurement of capacitance for the measurement of specific analytes to further allow for measurement of targeted biochemical compounds. As to claim 15, Richard-Burns teaches the is a protein or peptide that specifically binds to the receptor molecule ([0042]). As to claim 16, Chan teaches the level of the compound is detected in at least one ganglia selected from the group consisting of intrathoracic ganglia, stellate ganglia, autonomic ganglia, nodose ganglia, dorsal root ganglia and petrosal ganglia (H1093 - biopolar electrodes were placed into each stellate ganglion). As to claim 18, Chan teaches the one or more electrodes are placed into a tissue or organ via direct access (H1093 - median sternotomy was performed to expose the heart). As to claim 20, Chan teaches the one or more electrodes are placed into a tissue or organ via vascular access (H1098 - vascular insertion route). As to claim 23, Chan fails to teach the at least one measurement electrode comprises a receptor molecule that specifically binds to a biochemical compound. Richard-Burns teaches bioelectrodes for measuring analyte levels ([0186]) and teaches the functionalization of such biological components such as receptors ([0042]) which allows for the binding of the biological compound to the receptor for measurement ([0066]). Accordingly, it would have been obvious to modify Chan with Richard-Burns to utilize receptor molecules for the detection of specific, targeted analytes. As to claim 27, Chan fails to teach the reference electrode and one or more measurement electrodes each has a conductive substrate layer deposited on the electrode surface suitable for attachment/binding of IgG antibodies, IgG binding fragments (Fab), single-domain antibody fragments, and peptide binding domain fragments. Richardson-Burns teaches bioelectrodes comprising electrically conductive substrates (Abstract) suitable for attachment of biological components such as antibodies ([0042]) or peptides ([0056], [0081]). It would have been obvious to modify Chan with Richardson-Burns to incorporate the electrically conductive substrate to allow for the incorporation of biological components usable to detect specific biochemical compounds of interest . 07-21-aia AIA Claim (s) 17, 19, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al. (“Fast in vivo detection of myocardial norepinephrine levels in the beating porcine heart”) and Richardson-Burns et al. (US 2015/0369771), and further in view of Simpson et al. (US 2008/0197024) . As to claim 17, the above combination does not teach the one or more electrodes are placed in a peripheral artery or peripheral vein. Simpson teaches an electrochemical analyte sensor ([0404]) that is embodied on a catheter configured for insertion into a peripheral or central artery ([0351]). It would have been obvious to modify the above combination with Simpson to utilize placement via a peripheral artery to reach certain locations for the measurement of biochemical compounds of interest at specific sites while minimizing the invasiveness of the device compared to direct access. As to claim 19, the above combination does not teach the one or more electrodes are placed into a tissue or organ via transcutaneous access. Simpson teaches an electrochemical analyte sensor ([0404]) that can be employed on a transcutaneous device ([0410]).It would have been obvious to modify the above combination with Simpson to utilize placement via a transcutaneous placement to reach certain locations for the measurement of biochemical compounds of interest at specific sites while minimizing the invasiveness of the device. As to claim 24, the above combination does not teach a semi-permeable membrane applied to a portion of an electrode selected from the group consisting of the reference electrode, the measurement electrode, and the ground electrode. Simpson teaches a semi-permeable ([0613]) membrane system deposited over the electrodes ([0441]), to impart additional functionality such as incorporating enzymes necessary for the detection of certain analytes ([0477]), to block interferants ([0456]), or to control the flux of the analyte ([0482]). Accordingly, it would have been obvious to modify the above combination with Simpson to allow for measurement of specific biochemical compounds such as glucose . 07-21-aia AIA Claim (s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al. (“Fast in vivo detection of myocardial norepinephrine levels in the beating porcine heart”) and Richardson-Burns et al. (US 2015/0369771), and further in view of Kim et al. (“Electrochemical Co-deposition of Polydopamine/Hyaluronic Acid for Anti-biofouling Bioelectrodes”) . As to claim 28, the above combination fails to teach the conductive substrate layer is polydopamine. Kim teaches that the use of depositing a layer of polydopamine on bioelectrodes to improve anti-biofouling performances and improve performance (P1). Accordingly, it would have been obvious to modify the above combination further with Kim to impart anti-biofouling properties to in vivo sensors to improve device performance . 07-21-aia AIA Claim (s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al. (“Fast in vivo detection of myocardial norepinephrine levels in the beating porcine heart”) in view of Khan (USP #5,387,327) and Wang (USP #6,514,762) . As to claim 31, Chan does not teach sensitivity of the device is reset by applying a negative potential pulse configured to expel target molecules from capture agents on each of the one or more sensing electrodes, readying the capture agents for a subsequent binding of target molecules for further detection events. However, Khan teaches an implantable analyte detecting device with a variable voltage supplying scanner to remove any deposits on the electrode and to be self-cleaning (col. 5 lines 28-31). Moreover, Wang teaches a device in target molecules such as nucleotides can be released by pulsing a negative potential to cause desorption and release the target molecules (col. 9 lines 16-47). Accordingly, it would have been obvious to modify Chan with Khan and Wang to utilize a negative potential to remove target molecules from the electrodes, thereby inherently resulting in a reset of its sensitivity, to allow the device to self-clean to increase the longevity of the device. Response to Arguments Applicant submitted a declaration under 37 C.F.R 1.130 on 11/20/25 declaring the listed inventors as the sole co-inventors of the application. In doing so, applicant sought to invoke a 102(b)(1) exception, which states that a disclosure in question was made by the inventor or by another who obtained the subject matter directly or indirectly from the inventor, and that the cited Chan reference does not qualify as prior art under 35 USC 102(a)(1). MPEP 2155 states that “Where the authorship of the prior art disclosure includes the inventor or a joint inventor named in the application, an unequivocal statement from the inventor or a joint inventor that the inventor or joint inventor (or some combination of named inventors) invented the subject matter of the disclosure, accompanied by a reasonable explanation of the presence of additional authors , may be acceptable in the absence of evidence to the contrary (emphasis added). See In re DeBaun, 687 F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982).” However, the 130 declaration repeatedly misspells one of the authors of the paper, the first listed author “Shyue-An Chan” as “Shyue-An Chen ” (in fact, in every instance the full name is spelled out, it is misspelled), and is thus unclear whether the inventors are properly providing an explanation of the presence of this additional author. Second, while the declaration states that “Shyue-An Chen ” was named a co-author on the publication because the individual was a staff member of Corey Smith and “simply acting on our behest and direction to provide technical support and acquire data”, the publication itself states under “Author Contributions” that “M.V., K.S, J.L.A, and C.S.” (referring to Shyue-An Chan), “conceived and designed research” and notes that C.S. also took part in every aspect, including performing the experiments, analyzing data, interpreting results, preparing figures, and drafting, editing, and approving the final version of the manuscript. In addition, considering that the first listed author of a research paper is typically the one who has made the greatest intellectual and practical contribution to the work, the current declaration fails to provide a reasonable explanation of the presence of this additional author, particularly as the declaration misspells the actual name of the author. 07-39 AIA THIS ACTION IS MADE FINAL. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. CHRISTIAN JANG Primary Examiner Art Unit 3791 /CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 6/2/26 Application/Control Number: 18/002,995 Page 2 Art Unit: 3791 Application/Control Number: 18/002,995 Page 3 Art Unit: 3791 Application/Control Number: 18/002,995 Page 4 Art Unit: 3791 Application/Control Number: 18/002,995 Page 5 Art Unit: 3791 Application/Control Number: 18/002,995 Page 6 Art Unit: 3791 Application/Control Number: 18/002,995 Page 7 Art Unit: 3791 Application/Control Number: 18/002,995 Page 8 Art Unit: 3791 Application/Control Number: 18/002,995 Page 9 Art Unit: 3791 Application/Control Number: 18/002,995 Page 10 Art Unit: 3791 Application/Control Number: 18/002,995 Page 11 Art Unit: 3791 Application/Control Number: 18/002,995 Page 12 Art Unit: 3791
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