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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 1, it is unclear whether the “two or more electrodes” of the electrocardiogram measurement module and the “two or more electrode pads” of the electrical stimulation module can be the same electrodes or are required to be separate, distinct electrodes. In other words, it is unclear whether the electrocardiogram measurement module includes circuitry and two electrodes and the electrical stimulation module includes circuitry and two electrodes that may be the same electrodes as used in the electrocardiogram measurement module, or are required to be separate electrodes.
In regards to claim 9, it is unclear if or how the claim further limits the structure set forth in the apparatus claims. For instance, it is unclear whether this is a method step recited in an apparatus claim, an intended use drawn to electrodes and pads being capable of being placed in such a configuration if the user so chooses, whether the claim implies some sort of (unrecited) substrate to place the electrodes and pads in the recited configuration, or whether the claim somehow limits the control module’s functionality when the electrodes are placed in such a configuration.
The remaining claims are rejected by virtue of their dependency.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Lapanashvili et al. (US 2007/0198064, hereinafter “Lapanashvili”).
In regards to claim 1, Lapanashvili discloses an electrocardiogram monitoring device (Figs. 2A and 4), comprising:
an electrocardiogram measurement module (Fig. 4, elements 28 and 30; par. 0070) including two or more electrodes (elements 30; par. 0070) for electrocardiogram measurement to measure electrocardiogram of a user at a predetermined electrocardiogram signal acquisition cycle (pars. 0070 and 0001; the cycle being R-R intervals);
an electrical stimulation module (Fig. 4, elements 70 and 40; par. 0071) including two or more electrode pads (Fig. 1; elements 40), configured to contact with a skin of the user and provide electrical stimulation (Fig. 1; par. 0071); and
a control module configured to control operations of the electrocardiogram measurement module and the electrical stimulation module (Fig. 4; element 36),
wherein the control module is configured to control the electrical stimulation module to output the electrical stimulation between signal acquisition timings of the acquisition cycle (Fig. 2C; electrical stimulation 44 provided between R-waves) based on an electrocardiogram measurement result for the user from the electrocardiogram measurement module (Fig. 2C, par. 0077; “timed to start at the end of the T-phase of the ECG”).
In regards to claim 2, the electrical stimulation includes transcutaneous electrical nerve stimulation (TENS) (Fig. 2A, par. 0100).
In regards to claim 9 (as best understood) in the electrocardiogram monitoring device, a straight line connecting the two or more electrodes for measuring the electrocardiogram and a straight line connecting the two or more electrode pads providing the electrical stimulation appear to expressly be arranged perpendicular to each other (see annotated Fig. 2A below), and the electrodes and pads are capable of being placed as the clinician desires, including in such a configuration.
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In regards to claim 10, the device further comprises a communication module configured to transmit and receive data with a user terminal or external system through a network (Fig. 2A, element 104, par. 0118, “reference numeral 104 signifies an internet connection”).
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.
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lapanashvili in view of Hisamoto et al. (US 2022/0339449, hereinafter “Hisamoto”). Lapanashvili discloses the essential features of the claimed invention, but does not expressly disclose that the electrical stimulation module is configured to provide the electrical stimulation with a pulse width of 150 to 400 µs and a frequency of 15 to 25 Hz to the user.
However, Hisamoto in the same field of endeavor of neural stimulation teaches providing an electrical stimulation module that is configured to provide the electrical stimulation with a pulse width of 150 to 400 µs and a frequency of 15 to 25 Hz to the user (par. 0117; the operator can set the parameters via menu including the claimed ranges) to provide the predictable results of an effective stimulation signal suitable for the particular patient being treated (par. 0117). Further, Hisamoto recognizes that these are “results effective variables” and it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lapanashvili by providing an electrical stimulation module that is configured to provide the electrical stimulation with a pulse width of 150 to 400 µs and a frequency of 15 to 25 Hz to the user to provide the predictable results of an effective stimulation signal suitable for the particular patient being treated.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lapanashvili in view of Brockway et al. (US 2022/0054090, hereinafter “Brockway”). Lapanashvili discloses the essential features of the claimed invention except for wherein the electrocardiogram measurement module is configured to filter noise of an electrocardiogram signal by an adaptive noise canceller that uses an output signal of the electrical stimulation as a reference signal.
However, Brockway in the same field of endeavor of ECG signal denoising teaches providing an electrocardiogram measurement module that is configured to filter noise of an electrocardiogram signal by an adaptive noise canceller that uses an output signal of the electrical stimulation as a reference signal (Figs. 6 and 7A; see the bypass path triggered by a blanking pulse from the modulation system 410) to provide the predictable results of more accurately removing stimulation noise from an ECG signal in real time (par. 0017).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lapanashvili by providing an electrocardiogram measurement module that is configured to filter noise of an electrocardiogram signal by an adaptive noise canceller that uses an output signal of the electrical stimulation as a reference signal to provide the predictable results of more accurately removing stimulation noise from an ECG signal in real time.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Lapanashvili in view of Ziv (US 2019/0001131, hereinafter “Ziv”).
In regards to claim 5, Lapanashvili discloses the essential features of the claimed invention, including wherein the control module is configured to control the electrical stimulation module to output the electrical stimulation between the signal acquisition timings of the acquisition cycle based on the electrocardiogram measurement result for the user during the monitoring of the electrocardiogram measurement module (Fig. 2C and see above in regards to claim 1), but does not expressly disclose wherein the electrocardiogram measurement module includes a monitoring mode and a rest mode, wherein in the monitoring mode, the electrocardiogram measurement module acquires an electrocardiogram signal of the user at a measurement cycle timing of a predetermined pattern and measures electrocardiogram, and in the rest mode, the electrocardiogram measurement module stops measuring the electrocardiogram.
However, Ziv in the same field of endeavor of monitoring in combination with neurostimulation teaches providing an electrocardiogram measurement module (Fig. 3, elements 310 and 334) that includes a monitoring mode and a rest mode, wherein in the monitoring mode, the electrocardiogram measurement module acquires an electrocardiogram signal of the user at a measurement cycle timing of a predetermined pattern and measures electrocardiogram, and in the rest mode, the electrocardiogram measurement module stops measuring the electrocardiogram (par. 0104; “method 200 may involve switching/alternating between the stimulation mode and the monitoring mode. Following a (preset) period of stimulation, the module may automatically switch back to the monitoring mode to obtain updated values of the monitored heart parameters. The stimulation parameters are accordingly adjusted (i.e. taking into account the updated values). The module may then switch back to the stimulation mode and resume applying stimulation, and so on.”) to provide the predictable results of minimizing the required contacts to be placed on the patient (par. 0114).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lapanashvili by providing an electrocardiogram measurement module that includes a monitoring mode and a rest mode, wherein in the monitoring mode, the electrocardiogram measurement module acquires an electrocardiogram signal of the user at a measurement cycle timing of a predetermined pattern and measures electrocardiogram, and in the rest mode, the electrocardiogram measurement module stops measuring the electrocardiogram to provide the predictable results of minimizing the required contacts to be placed on the patient.
In regards to claim 7, Lapanashvili discloses the essential features of the claimed invention except wherein during the monitoring mode, when the electrocardiogram measurement result for the user from the electrocardiogram measurement module returns to a predetermined normal range, the control module controls the electrical stimulation module to stop providing the electrical stimulation to the user.
However, Ziv in the same field of endeavor of monitoring in combination with neurostimulation teaches wherein during the monitoring mode, when the electrocardiogram measurement result for the user from the electrocardiogram measurement module returns to a normal range, controlling the electrical stimulation module to stop providing the electrical stimulation to the user (par. 0101), and it is further well known in the art to provide automatic control based on measurement thresholds to provide the predictable results of providing stimulation only when needed (par. 0101).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lapanashvili by, during the monitoring mode, when the electrocardiogram measurement result for the user from the electrocardiogram measurement module returns to a predetermined normal range, the control module controls the electrical stimulation module to stop providing the electrical stimulation to the user to provide the predictable results of providing stimulation only when needed.
Allowable Subject Matter
Claims 3 and 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Whiting et al. (US 2013/0325078) is another example of denoising of monitoring a patient during stimulation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792