DETAILED ACTION
The Examiner acknowledges the amendments received 23 July 2026. New claims 11-12 are added; claims 1-12 are pending.
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 .
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Rejections - 35 USC § 101
In view of the amendments received 23 July 2026, the Examiner withdraws the rejection of claims 1-10 under 35 USC 101.
Response to Arguments
Applicant's arguments filed 23 July 2026 have been fully considered but they are not persuasive. Applicant argues (page 9, “Remarks”) “It is evident that the reference electrodes (ground electrodes) 122 are not disposed between the electrodes 106, but are disposed respectively at the opposite ends of a plurality of electrodes 106.”
The Examiner respectfully disagrees with this assessment of Clements, and refers to Fig. 2, previously cited and provided below in the prior art rejection. The reference numeral 122 labeled “ground electrode” (in Examiner’s annotated Figure) is clearly depicted between 106 and the reference numeral 122 labeled “1st, 2nd electrode”.
Applicant further argues (page 10, “Remarks”) “the position has been taken that the "separate isolated circuit is used to provide a very-high impedance ground connection to the patient" taught in Clements ¶0166 allegedly reads on the claimed --impedance element--. However, the "separate isolated circuit" in Clements is not configured to consume a noise signal that flows backward toward the reference terminal, but instead is configured to place the patient in a floating state. Consequently, Clements fails to teach the limitation of --an impedance element including a first end connected to each of the ground terminal and the common terminal, and a second end connected to the reference terminal-- recited in independent claim 1.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “impedance element configured to consume a noise signal that flows backward toward the reference terminal”) are not recited in the rejected claim (1). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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.
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Claims 1-2 and 4-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clements et al (U.S. 2020/0138313). Clements discloses (Figure 2, annotated below) a first electrode disposed in a measurement area of a body according to the biosignal to be measured; a second electrode disposed in the measurement area; a ground electrode (par. 0060, “the electrode array 104 includes one or more reference electrodes 122 (or ground electrode, driving electrode, etc.).”) disposed between the first electrode and the second electrode in the measurement area; a differential circuit configured to generate a differential voltage (par. 0086) between a first voltage input from the first electrode and a second voltage input from the second electrode (“The stimulation artifact, a result of the high voltages required to elicit a response through the skin, is in turn a direct consequence of the induced electric field from the stimulation leads and circuitry, the potentials (differential and common mode) induced in the body, the accumulated charge in the electrode interface, and of the effect that these induced voltages have on the signal-chain filters and other elements after stimulation.”); an output circuit including an input terminal to which the differential voltage is input, a reference terminal to which a reference voltage is input, and a common terminal, the output circuit being configured to generate a measurement signal based on the differential voltage and the reference voltage, and to output the generated measurement signal; a ground terminal connected to each of the ground electrode, the differential circuit, and the output circuit; and an impedance element (par. 0166, “a separate isolated circuit is used to provide a very-high impedance ground connection to the patient (see e.g., circuitry of FIG. 1), essentially leaving the patient floating instead of connected to the instrumentation ground. In this modified version, the data acquisition equipment ground is driven to match the potential of the patient.”) including a first end connected to each of the ground terminal and the common terminal, and a second end connected to the reference terminal.
Regarding claim 2, Clements discloses (par. 0166) the impedance element has an impedance equal to or greater than a bioimpedance of a living body (“a separate isolated circuit is used to provide a very-high impedance ground connection to the patient (see e.g., circuitry of FIG. 1), essentially leaving the patient floating instead of connected to the instrumentation ground. In this modified version, the data acquisition equipment ground is driven to match the potential of the patient.”).
Regarding claim 4, Clements discloses (par. 0190) the biosignal to be measured is at least an electromyographic signal.
Regarding claim 5, Clements discloses (par. 0108) the impedance element is at least a diode.
Regarding claim 6, Clements discloses (par. 0066 and 0096-0097) the output circuit includes an analog-to-digital converter configured to convert the differential voltage into a digital signal based on the differential voltage and the reference voltage, and to output the converted digital signal as the measurement signal.
Regarding claim 7, Clements discloses (par. 0066) the output circuit includes a wireless communication circuit configured to convert the measurement signal into a wireless signal and to output the wireless signal to an external device (“a communication link may be implemented by any medium that facilitates data exchange between the electronics module 150 and the electrode patch including, but not limited to, wired, wireless and optical links. In some implementations, the electronics module can be a computing device (e.g., computing device 200 of FIG. 15).”).
Regarding claim 8, Clements discloses (par. 0091) an amplifier circuit configured to amplify the differential voltage and input the amplified differential voltage into the output circuit.
As to claim 9, the functional language and statement of intended use have been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Clements utilizes an electrode configured for attachment to a patient to obtain physiological signals as claimed by the applicant, Clements is therefore capable of being used on a back. Furthermore, it is unclear as written whether the system is intended for use on the back of a patient (i.e., the dorsal side of the body), or on back of some other structure. In addition nothing prevents Clements’ system from being used on a back. Therefore, they are capable of measuring a patient’s back.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Clements et al (U.S. 2020/0138313). Clements discloses the claimed invention except for the impedance of the impedance element is 3 to 10 times the bioimpedance. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide an impedance element of 3 to 10 times the bioimpedance, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. In the Applicant’s published Application, a range of impedances are given, such as “1 to 10 times, preferably 3 to 5 times” (par. 0041) or “3 to 10 times, preferably 3 to 5 times” (par. 0055) the bioimpedance, with no explanation as to why these impedances are preferred or critical to the functioning of the device. Therefore, the relationship between the impedance of the impedance element and the bioimpedance is not a critical and result effective variable. See MPEP 2144.05(II).
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Clements et al (U.S. 2020/0138313) in view of (Lim et al, “The ECG Measurement in the Bathtub Using the Insulated Electrodes”). Clements discloses the claimed invention except for the first electrode, the second electrode, and the ground electrode are attached to an inner surface of a bathtub. Lim, however, discloses (Figures 2-3, par. 1-2 on p. 2384) use of two electrodes including differential circuitry embedded within a bathtub for measuring ECG.
Clements and Lim both disclose electrodes for measuring ECG (see par. 0055 of Clements). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Clements’ ground electrode and impedance element system with Lim’s bathtub ECG electrodes in order to provide daily health monitoring during a routine bath (“Introduction” of Lim) for increased patient compliance.
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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