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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02 MARCH 2026 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a measurement module” in Claim 1
The claim limitation is interpreted according to paragraphs [0042] and [0043] of the instant specification: “…the measurement module measures biometric information such as blood glucose and so on based on the response signal. The measurement module transmits the measured biometric information to the communication terminal in real time or periodically or when the communication terminal requests it.” and whether it is “integral”, “separable from”, or “couplable to” the sensor with “connection terminals.” It is identified as a generic box component “measurement module” 300 in Figure 4. Further see paragraphs [0018] and [0020] and [0081] for the module comprising the circuitry and power supply and sensor to perform the apply power and measure functions. Also interpreted to be equivalents thereof of those elements.
“a load unit” in Claims 1 – 8. (“to add an additional impedance“ in Claim 1, to be “connected in series” in Claims 2 and 3, to be “formed at a body of the sensor” Claim 4, to be “formed as a connection terminal” Claim 5, to “reduce a level of noise” in Claim 6, and have “additional impedance” in Claim 8.)
The claim limitation is interpreted according to paragraph [0060] of the instant specification: “includes a load unit (200) configured to relatively suppress a noise level applied to the response signal generated by the sensor (100) when the sensor (100) is physically deformed by providing an additional impedance to a sensor impedance of the sensor (100). Here, the magnitude of the additional impedance of the load unit (200) is larger than the magnitude of the sensor impedance of the sensor (100). Preferably, it is characterized in that the load unit (200) is a resistor of 1OKΩ to 10GΩ.” It is identified as a generic box component “Load Unit 200” in Figure 4.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Oh et al. (KR20160132750A), in view of Harley-Trochimeczyk, et. al., (US 2019/0227022 A1).
Regarding Claim 1, Oh discloses An apparatus ([Page 1, Line 14] “an electrochemical biosensor”) for measuring biometric information ([Page 1, Lines 17 - 21] including “Biosensors are analytical sensors that calculate the concentration or presence of a biological analyte”), the apparatus ([Page 1, Line 14] “an electrochemical biosensor”) comprising:
a sensor ([Page 1, Line 14] “an electrochemical biosensor”) including a bioelectrode configured to be insertable into skin ([Page 5, Lines 51 – 54] including “…the invasive electrode may include a needle shape to invade the inside of the object 10.”);
a measurement module (Figure 1, including Block Diagram boxes 132 and 142: “first magnetic pole” 132 and “1st detection unit” 142; [Page 6, Lines 9 and 22 - 23] “the first magnetic pole unit 132 may be implemented as a voltage source”, “When the first electrical stimulus is a voltage, the first detector 142 may be an ammeter that detects a current”); configured to apply a measurement power to the bioelectrode ([Page 5, Lines 45 - 46] “if the input impedance of a voltage source 45 applying a voltage to an impedance electrode…”) and measure the biometric information based on a response signal received from the bioelectrode ([Page 5, Lines 19 - 24] including “a composite electrode 20 capable of applying a first electrical stimulus to the subject 10 through one impedance electrode and receiving an electrical response from the subject 10,”; [Page 9, Lines 28 – 30] “…the more target material, the greater the change in electrical response. Thus, the biosensor 100 may obtain information about the target material as the amount of change in bioimpedance.”); and
a load unit ([Page 5, Lines 45 - 48] “…an ammeter…”) configured to add an additional impedance ([Page 5, Lines 45 - 48] “…and the output impedance of an ammeter…”) to a sensor impedance of the sensor to reduce a level of noise applied to the response signal by physical deformation of the sensor ([Page 5, Lines 45 - 48] “if the input impedance of a voltage source 45 applying a voltage to an impedance electrode and the output impedance of an ammeter detecting a current of the impedance electrode are considerably larger than the contact impedance, the influence of the impedance and the contact impedance of the impedance electrode itself is minimized”)(Examiner notes that “contact impedance” is impedance and noise that is associated with the interface of the connection between an electrode and a person’s skin/body. The person’s movement and resultant sensor movement is part of this “contact impedance”.)
wherein a level of the additional impedance ([Page 5, Lines 46 - 47] “…and the output impedance of an ammeter…”) is greater than a level of the sensor impedance ([Page 5, Lines 46 – 47] “…and the output impedance of an ammeter detecting a current of the impedance electrode are considerable larger than the contact impedance…”)(Examiner notes that the “contact impedance” associated with an electrode and is the sensor impedance.).
and response signal considering the additional impedance of the load unit ([Page 5, Lines 45 - 48] “if the input impedance of a voltage source 45 applying a voltage to an impedance electrode and the output impedance of an ammeter detecting a current of the impedance electrode”)
Oh does not disclose comprises a temperature sensor configured to measure a temperature of the load unit, and the biometric information is measured from the response signal that is changed according to the temperature measured by the temperature sensor.
Harley-Trochimeczyk teaches systems and methods to compensate for the effects of temperature on sensors, such as an analyte sensor [Abstract]. Specifically for Claim 1, Harley-Trochimeczyk teaches the measurement module comprises a temperature sensor configured to measure a temperature of the load unit ([0411] “measuring a temperature parameter of a component of a wearable glucose sensor…”; Fig 10, [0523] “a potentially overheating or excessively cold sensor or sensor electronics may be detected. In some examples, a potentially faulty temperature sensor may be identified based upon a temperature sensor signal satisfying a condition (e.g., when the temperature sensor indicates a temperature in an unlikely range.)”; [0512] “the sensor may be built in to sensor electronics for other reasons (e.g., to detect overheating)“; [00542])(Examiner notes that measuring a component of the wearable glucose sensor could broadly include a load unit.)
the biometric information is measured from the response that is changed according to the temperature measured by the temperature sensor ([0386] “ A signal generated by the thermocouple may be communicated to sensor electronics for processing (i.e., for use in compensating glucose sensor values for temperature.”; [0356] “the processor module 214 may transform sensor data into one or more of the following: temperature-compensated data,“; [0288] “compensate for the effects of temperature on glucose sensors…”; [0338] “accuracy and precision of estimated glucose concentration levels can be improved by compensating for temperature fluctuations…in the sensor…”; [0391])
The temperature sensing of a component of the analyte sensor taught by Harley-Trochimeczyk would perform the same function to modify the measurement signal to compensate for temperature effects on the sensing components if combined with the “electrochemical biosensor” system with the electronic support components in Figure 1 of Oh. Therefore, it would have been predictable to use the temperature sensing of a component of the analyte sensor to compensate the analyte measurement taught by Harley-Trochimeczyk in any similar invasive bioelectrode system as it would continue to operate with the function of measuring biosignals in the body. Further, Harley-Trochimeczyk teaches a motivation to combine with Oh at [0338] with “…temperature variations can cause inaccuracies in estimation of glucose concentration levels. The accuracy and precision of estimated glucose concentration levels can be improved by compensating for temperature fluctuations at the sensing site or in the sensor when the sensor is worn by a host. “ A person of ordinary skill in the art before the effective filing date of the claimed invention would recognize that accounting for temperature change in the sensor readings would yield more accurate analyte results from the measurement device, particularly since unaccounted temperature variations can cause inaccuracies in glucose concentration level estimation by a sensor.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “electrochemical biosensor” system with the electronic support components in Figure 1 disclosed in Oh and the analyte sensor component temperature measurement and resultant analyte measurement compensation taught by Harley-Trochimeczyk, creating a single apparatus to measure biosignals in the body while accounting for temperature effects on the sensing components.
Claims 2 - 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Oh et al. (KR20160132750A) in view of Harley-Trochimeczyk, further in view of Alcidi, (US Patent 4,009,721).
Regarding Claim 2, Oh in view of Harley-Trochimeczyk discloses as described above, The apparatus for measuring biometric information according to claim 1. For the remainder of Claim 2, Oh discloses the bioelectrode comprises a working electrode ([Page 5, Line 46] “impedance electrode”) and a reference electrode ([Page 5, Line 11] “reference electrode”), and
Oh does not specifically disclose the load unit is connected in series with the working electrode, or is connected in series with the reference electrode, or is connected in series with the working electrode and the reference electrode, respectively. Oh does broadly disclose that “the output impedance of an ammeter detecting a current of the impedance electrode” is “considerably larger than the contact impedance”, indicating that these components are connected in a circuit, without specifying that they are or are not in series.
Alcidi teaches an implantable electrode system for a pacemaker that incorporates an impedance adapter that provides a large impedance in series with the measuring electrode. Specifically regarding Claim 2, Alcidi teaches the load unit ([Col 3, Lines 61 – 64] “the active impedance adapter 12”) is connected in series with the working electrode ([Col 3, Lines 61 – 64] “The electric circuit of the indicating-reading electrode includes, in series, a high impedance, of the order of about 1012 Ohms, of the active impedance adapter 12.”) or is connected in series with the reference electrode, or is connected in series with the working electrode and the reference electrode, respectively.
Oh provides a motivation to combine with Alcidi’s teaching, disclosing that the presence of the ammeter with “considerably larger than the contact impedance” makes it so that the “influence of the impedance and the contact impedance of the impedance electrode itself is minimized.” A person having ordinary skill in the art before the effective filing date of the invention would recognize that connecting the large impedance component (“active impedance adapter 12”) in series with the measurement electrode, as taught by Alcidi, would directly beneficially influence and “minimize” the impedance of the measurement electrode in the circuit.
The technique of connecting the high impedance “active impedance adapter 12” in series with the “indicating-reading electrode” taught by Alcidi can be combined with the “considerably larger output impedance ammeter” and “impedance electrode” disclosed by Oh. An ammeter in circuit with an impedance electrode as disclosed in Oh could be specifically connected in series with each other in the same way that “active impedance adapter 12” is in series with the “indicating-reading electrode” in Alcidi. The improvement to directly tie the high impedance component into the circuit to advantageously affect a specific electrode – specifically connecting the high impedance “active impedance adapter 12” in series with the “indicating-reading electrode” -- thus directly affecting the overall impedance effects from the critical “Indicating-reading electrode”-- would be recognized by one of ordinary skill in the art to perform the same improvement for Oh’s “ammeter” and “contact impedance of the impedance electrode”. It would be recognized to yield predictable results and result in an improved system, namely, a system that would allow control of the impedance effects associated with the contact impedance on a particular electrode.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the known technique of connecting a high impedance component in series with a particular electrode of Alcidi with the “considerably larger output impedance ammeter” and “impedance electrode” of Oh in order to create a biosensing system with lessened impedance effects on the measurement from an electrode. The applicant would be motivated to combine the teachings of Oh and Alcidi in order to create a single apparatus to more accurately measure bio-signals with reduced contact impedance noise. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious.
Regarding Claim 3, Oh in view of Harley-Trochimeczyk, further in view of Alcidi discloses as described above, The apparatus for measuring biometric information according to claim 2, wherein the load unit is arranged in series with the bioelectrode.
For the remainder of Claim 3, Oh does not disclose inside a housing of the measurement module. Oh does not specifically disclose the presence or absence of a housing structure for its biosensing device.
Harley-Trochimeczyk teaches an invasive biosensor for detecting an analyte concentration in the blood. Specifically for Claim 3, Harley-Trochimeczyk teaches inside a housing of the measurement module ([0381] “housing 266…housing may contain some of all of the components shown in Fig. 2A or the sensor electronics 12 shown in Fig. 2B”; Fig 2A, Fig 2b)
Harley-Trochimeczyk provides a motivation to combine at [0382] with “the housing may include a heat shield 272 on a top surface…to reflect heat from the housing, which may, for example, reduce the impact of sunlight on the sensor 10.“ A person of ordinary skill in the art before the effective filing date of the claimed invention would recognize that by enclosing the electronic circuitry in a chassis, or housing, the electronics may be protected from heat from sunlight or short circuiting from the fluids in its operating environment, yielding a more reliable bio-measurement device.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the invasive bioelectrode system device high impedance component, associated measurement electronics, and electrode disclosed in Oh and the enclosing electronics in a housing taught by Harley-Trochimeczyk, creating a single, protected apparatus capable of more-reliably operating in the liquids and heat hazards of the biological environment via protective housing. The combination of Oh in view of Alcidi for the components to be in series does not alter Phan’s teaching of a housing to enclose the electrical components. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious.
Regarding Claim 7, Oh in view of Harley-Trochimeczyk and Alcidi discloses, as described above, The apparatus for measuring biometric information according to claim 3.
For the remainder of Claim 7, Oh does not disclose wherein the load unit is a resistor of 1OKΩ to 1OGΩ. Oh broadly discloses that the output impedance of the ammeter is “considerably larger than the contact impedance” without specifying a particular number of Ohms (or GOhms) for that larger impedance.
Alcidi teaches wherein the load unit ([Col 3, Lines 13 - 16] “active impedance adapter 2.”) is a resistor of 1OKΩ to 1OGΩ ([Col 3, Lines 13 – 16] “The electrical circuit of the indicating-reading electrode and the reference electrode is completed by a high impedance, of the order of several GOhms, of the active impedance adapter 2.”).
Oh provides a motivation to combine with Alcidi’s teaching, disclosing that the presence of the ammeter with “considerably larger than the contact impedance” makes it so that the “influence of the impedance and the contact impedance of the impedance electrode itself is minimized.” A person having ordinary skill in the art before the effective filing date of the invention would recognize that connecting the “high impedance” component with specifically “on the order of several GOhms” with the measurement electrode, as taught by Alcidi, would directly beneficially influence and “minimize” the impedance of the measurement electrode in the circuit.
The technique of connecting the high impedance “active impedance adapter 12” with the “indicating-reading electrode” taught by Alcidi can be combined with the “considerably larger output impedance ammeter” and “impedance electrode” disclosed by Oh. An ammeter in circuit with an impedance electrode as disclosed in Oh could be specified for impedance “on the order of several GOhms” in the same way that “active impedance adapter 12” is with the “indicating-reading electrode” in Alcidi. The improvement to connect a high impedance component into the circuit to advantageously affect a specific electrode – specifically an impedance on the order of several GOhms -- thus directly affecting the overall impedance effects from the critical “Indicating-reading electrode”, would be recognized by one of ordinary skill in the art to perform the same improvement for Oh’s “ammeter” and “contact impedance of the impedance electrode”. It would be recognized to yield predictable results and result in an improved system, namely, a system that would allow control of the impedance effects associated with the contact impedance on a particular electrode.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the known technique of connecting a high impedance component of several GOhms with a particular electrode of Alcidi with the “considerably larger output impedance ammeter” and “impedance electrode” of Oh in order to create a biosensing system with lessened impedance effects on the measurement from an electrode. The applicant would be motivated to combine the teachings of Oh and Alcidi in order to create a single apparatus to more accurately measure bio-signals with reduced contact impedance noise. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. And it would have been obvious since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art, In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). MPEP 2144.05 (II-B), a person having ordinary skill in the art before the effective filing date of the invention would recognize that Alcidi teaching “several GOhms” could be within the 10KOhms – 10GOhms range.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Oh et al. (KR20160132750A), hereinafter Oh, in view of Harley-Trochimeczyk (US 2019/0227022 A1), and Alcidi, (US Patent 4,009,721), further in view of Phan (US 2008/0249385 A1).
Regarding Claim 6, Oh in view of Harley-Trochimeczyk, further in view of Alcidi discloses, as described above, The apparatus for measuring biometric information according to claim 3, wherein the measurement module. For the remainder of Claim 6, Oh discloses and of which the level of the noise is reduced by the load unit ([Page 5, Lines 45 - 48] “if the input impedance of a voltage source 45 applying a voltage to an impedance electrode and the output impedance of an ammeter detecting a current of the impedance electrode are considerably larger than the contact impedance, the influence of the impedance and the contact impedance of the impedance electrode itself is minimized”)(Examiner notes that “contact impedance” is impedance and noise that is associated with the interface of the connection between an electrode and a person’s skin/body. The person’s movement and resultant sensor movement is part of this “contact impedance”.).
For the remainder of Claim 6, Oh does not disclose wherein the measurement module further comprise a low frequency band pass filter configured to filter a high frequency component of the noise from the response signal.
Harley-Trochimeczyk teaches an invasive biosensor for detecting an analyte concentration in the blood. Specifically for claim 6, Harley-Trochimeczyk teaches further comprise a low frequency band pass filter ([0037], “low-pass filter 39”) configured to filter a high frequency component of the noise from the response signal ([All of 0037] including“…After the low-pass filter 39 filters out high-frequency noise, it may pass signals CE_REF, WE1 and WE2”)
The low-pass filter 39 of Phan would perform the same function of filtering high frequency components from noise from bioelectrode signals if combined with the measured “electrical response” signals and circuitry of Oh. Therefore, it would have been predictable to use the low-pass filter 39 of Phan in any similar implantable bioelectrode circuit, as it would continue to operate with the function of smoothing the measured signal, removing high frequency noise. Further, Phan discloses a motivation to combine Oh with a low-pass filter, since it can be used to “filter out high-frequency noise”. A person of ordinary skill in the art before the effective filing date of the claimed invention would recognize that using a incorporating a low-pass filter would reduce the high-frequency noise in the measured signal, yielding more reliable, easier-to-analyze data from the bio-measurement device.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the measured “electrical response” signals and circuitry disclosed in Oh and the low-pass filter 39 taught by Phan, creating a single apparatus to more accurately measure bio-signals with reduced high-frequency noise. All claimed elements are known in prior art and could have been combined with no change to their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time the invention was properly filed.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Oh et al. (KR20160132750A), hereinafter Oh, in view of Harley-Trochimeczyk (US 2019/0227022 A1), and Alcidi, (US Patent 4,009,721), further in view of Riddle et. al., (US Patent US 6,842,640 B2).
Regarding Claim 4, Oh in view of Harley-Trochimeczyk, further in view of Alcidi discloses, as described above, The apparatus for measuring biometric information according to claim 2. For the remainder of Claim 4, Oh discloses wherein the load unit ([Page 5, Lines 45 - 48] “…an ammeter…”)
Oh does not disclose is formed at a body of the sensor and is formed as a electrically connecting the bioelectrode and the measurement module.
Riddle teaches a patch device for delivering therapeutic agents in an bioelectrode-based system. Specifically regarding Claim 4, Riddle teaches wherein the load unit is formed at a body of the sensor (Fig 2, “integrated circuit 19” within the sensor body housing) and is formed as a tracer (“conductive traces”) electrically connecting the bioelectrode and the measurement module (“The controller 216 is an integrated circuit having internal components connected by conductive traces formed during the integrated circuit manufacturing process.”)
The “integrated circuit 19” within the sensor body housing of Riddle can be combined with the “ammeter” connection electronics and “electrochemical biosensor” system of Oh. Oh is open to combine with Riddle’s integrated “controller” circuit, since the load unit “ammeter” in Oh is a “detection unit” of Oh’s Figure 1. A person having ordinary skill in the art before the effective filing date of the invention would recognize that the electrical connections that are the link between the electrodes and the control unit would benefit from being connected on an integrated circuit, simplifying the connection points for use with a patient. Integrated circuits are a common design choice in the art for a finished, user-friendly medical device. The improvement to integrate Riddle’s electronics into an all-in-one circuit within the sensor body housing, thus making it more compact with consistent wiring hookups for use with a patient, would be recognized by one of ordinary skill in the art to perform the same improvement for Oh’s “ammeter” connection electronics and “electrochemical biosensor” system . It would be recognized to yield predictable results and result in an improved system, namely, a system that would allow for a consistently-wired wearable bioelectrode device.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the known technique of incorporating electronics into an integrated circuit of Riddle with the “electrochemical biosensor” system of Oh in order to create a system with consistent wiring connections for use in measuring patients’ biosignals. The applicant would be motivated to combine the teachings of Oh and Riddle in order to create a biosensor system that can be worn by a user for consistent measurement results due to consistent component connection. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Oh et al. (KR20160132750A), hereinafter Oh, in view of Harley-Trochimeczyk (US 2019/0227022 A1), and Alcidi, (US Patent 4,009,721), further in view of Lee (KR20150044181A).
Regarding Claim 5, Oh in view of Harley-Trochimeczyk, further in view of Alcidi discloses, as described above, The apparatus for measuring biometric information according to claim 2.
For the remainder of Claim 5, Oh does not disclose the sensor and the measurement module are coupled separably to each other, and the load unit is formed as a connection terminal electrically connecting the sensor and the measurement module to each other when the sensor and the measurement module are coupled. However, Oh is open to combine with Lee’s connection terminal because it broadly discloses that the ammeter is connected to the electron to “detect a current”, but Oh does not specify how it is connected, whether separably or not.
Lee teaches wherein: the sensor ([0030] “measuring electrode” 100) and the measurement module are coupled separably to each other ([All of 0046 and 0047] including “the ECG controller 300 may be detachably mounted to the electrode mounting hole 200, and the electrode mounting hole 200 may be detachably mounted on the electrode mounting hole 200.” And “the electrode mounting hole 200 is provided with a signal line 400 for electrically connecting the electrode terminal 110 and the ECG controller 300”), and
the load unit is formed as a connection terminal ([0030] “electrode terminal 110”) electrically connecting the sensor and the measurement module to each other when the sensor and the measurement module are coupled ([0030] “the electrode terminal 110 includes an electrocardiogram signal, for example, an active current”; [0046] “In addition, the electrode mounting hole 200 is provided with a signal line 400 for electrically connecting the electrode terminal 110 and the ECG controller 300, so that the ECG signal input through the electrode 100 is controlled by the controller (300).”)
The “electrode terminal” for “detachably mounting” electronic circuitry with a bioelectrode of Lee can be combined with the “ammeter” connection electronics and “electrochemical biosensor” system of Oh. Oh is open to combine with Lee’s “electrode terminal” and “detachably mounting” electronic circuitry with a bioelectrode as it does not specify how its electrodes are connected ammeter, or “detection unit” and “controller”, merely that they are connected (as shown in the block diagram, Drawing 1). A person having ordinary skill in the art before the effective filing date of the invention would recognize that the electrical connections that link between the electrodes and the high impedance load unit (Oh’s “ammeter”) would benefit from being connected with a separably coupled connection terminal, allowing for quick connect and disconnect for patients during use (much in the way that the well-known ECG electrodes connect and disconnect in hospitals and clinics). Separably-connecting electrode interfaces are a common design choice in the art for a flexible, user-friendly medical device. The improvement to integrate Lee’s connection terminal on the electrode for connecting to the electronic components that support the electrode, thus making the components separably connectable for use with a patient, would be recognized by one of ordinary skill in the art to perform the same improvement for Oh’s “ammeter” connection electronics and “electrochemical biosensor” system. It would be recognized to yield predictable results and result in an improved system, namely, a system that would allow for a wearable bioelectrode device that can be disconnected and reconnected from controller equipment.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the known technique of an “electrode terminal 110” for “detachably mounting” electronic circuitry with a bioelectrode with the “ammeter” connection electronics and “electrochemical biosensor” system of Oh in order to create a system with removable wiring connections for maneuverability with human patient use. The applicant would be motivated to combine the teachings of Oh and Lee in order to create a biosensor system that can be worn by a user and disconnected for comfort between measurements or maneuverability. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious.
Response to Arguments
Applicant's arguments filed 02 March 2026 have been fully considered but they are not persuasive to overcome the 35 U.S.C. 103 rejections for Claims 1 – 7.
Regarding 35 U.S.C. 103 Rejections:
Applicant argues at [Page 4, “Claim Rejections – 35 U.S.C. 103” Section] – [Page 6, 2nd Full Paragraph] that Phan does not make up for Oh’s failure of teaching a temperature sensor configured to measure a temperature of the load unit”, such that Oh and Phan do not disclose or teach all of the limitations of Claim 1. Based on the amendment to the claim and arguments, a new rejection is made using the combination of Oh and Harley-Trochimeczyk. The argument is not persuasive.
Applicant summarily argues at [Page 6, 3rd Full Paragraph] that Claims 2 – 7 are patentable under 35 U.S.C. 103 due to their dependence on Claim 1. Based on the 35 U.S.C 103 rejections and the discussion above, Claim 1 is not patent eligible. The argument is not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jenkins et. al., teaches a flexible skin-mounted electrode system with 30d printed integrated elements to allow for control of the working electrode temperature, with a thermocouple to measure the temperature of the electrode to allow for feedback control to compensate for temperature effects on the measurement.
Veen, et. al. (US 2012/0116198 A1), teaches inclusion circuit electronics in an electrode system to minimize motion-induced signals, including a bias resistor.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791