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 .
Remarks
Claims 1-11, filed 11/04/2024, are currently pending and are under consideration.
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 3, 5, 7, and 9 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.
Claim 3 recites the limitation "the biological impedance" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitations " the voltage of the stimulation signal" in line 2, “the constant current square wave electrical stimulation signal” in lines 2-3, “the simplified impedance” in line 3, and “the simplified model” in lines 3-4. There is insufficient antecedent basis for these limitations in the claim.
Claim 7 recites the limitation " calculating the impedance as a function of frequency" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9, the phrase “one or more lookup tables comprises that correlate” is unclear.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method for determining the condition of hydrogel pads. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed towards a method and meets the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claim 1 is directed towards a method for determining the condition of hydrogel pads, comprising providing stimulation electrodes through which a neurostimulation signal is applied, providing a controller that supplies a modulated electrical stimulation signal, and measuring impedance values to assess changes in the impedance. The limitation of method for determining the condition of hydrogel pads, as drafted in claims 1-9, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind or using pen and paper or generic computer components.
For example, a user could provide stimulation electrodes through which a neurostimulation signal is applied, provide a controller that supplies a modulated electrical stimulation signal, and measure impedance values to assess changes in impedance values to determine hydrogel condition.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
As claimed and understood, the crux of the invention is the data processing performed to determine the condition of the hydrogel pads. The steps of providing stimulation electrodes through which a neurostimulation signal is applied, providing a controller that supplies a modulated electrical stimulation signal, and measuring impedance values are considered to be a mere data gathering step, and the step of assessing changes in the impedance is considered to be a data analysis step.
The additional elements of stimulation electrodes and a controller are recited at a high level of generality (i.e., as generic computing elements performing the steps of gathering and analyzing data) such that they amount to no more than mere instructions to apply the exception using a generic computer component. The stimulation electrodes provide generic structure for the insignificant, extra-solution activity of data gathering and output.
Accordingly, these additional elements do no integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination is not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of stimulation electrodes and a controller amounts to no more than mere instructions to apply the exception using generic data analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Furthermore, the additional elements do not amount to more than generically linking the use of a judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). Therefore, the claims are not patent eligible.
Claims 2-9 depend on claim 1 and recite the same abstract idea as claim 1 from which they depend. Further, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claims 2-9 (i.e. providing details about the data analysis performed) are further data analysis steps. The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provides a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
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.
Claims 1-3, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jeffrey et al. (International Publication WO 2023/069593), hereinafter Jeffrey.
Regarding claim 1, Jeffrey discloses a method for determining the condition of hydrogel pads of a transcutaneous neurostimulation system (e.g. Abstract; Par. [0020]), comprising: providing one or more stimulation electrodes comprising a hydrogel pad through which a transcutaneous neurostimulation signal is applied to skin of the subject (e.g. Par. [0019]; Pars. [0021]-[0022]: transcutaneous neurostimulation therapy system); providing a controller operatively connected to the stimulation electrodes and being configured to supply a modulated electrical stimulation signal to the stimulation electrodes (e.g. Pars. [0032]-[0033]: providing electrical stimulation); and configuring the controller to measure impedance values of the system and assess changes in system impedance as an indication of the condition of the hydrogel pads (e.g. Fig. 5: impedance detection circuitry 530; Par. [0036]; Par. [0020]: the stimulation unit detects the condition of the hydrogel).
Regarding claim 2, Jeffrey further discloses wherein the impedance of the system comprises the impedance of the stimulated portions of the human body, the impedance of the hydrogel pads, and the impedance of the skin-hydrogel pad interface (e.g. Par. [0037]: measuring impedance).
Regarding claim 3, Jeffrey further discloses wherein configuring the controller to measure impedance values of the system comprises configuring the controller to implement a simplified electrical model for the biological impedance of the neurostimulation system (e.g. Par. [0037]: measuring impedance).
Regarding claim 10, Jeffrey further discloses an apparatus for applying electrical stimulation to a target peripheral nerve in a subject according to claim 1, comprising: one or more stimulation electrodes comprising a hydrogel pad (e.g. Par. [0019]; Pars. [0021]-[0022]: transcutaneous neurostimulation therapy system); a wearable structure for supporting the stimulation electrodes (Figs. 2A, B: wearable device); and a controller for controlling the operation of the stimulation electrodes and for implementing the method of claim 1, wherein the control unit is further configured to: energize the stimulation electrodes to apply stimulation to a target nerve (e.g. Pars. [0032]-[0033]: providing electrical stimulation; Pars. [0021]-[0022]: transcutaneous neurostimulation therapy system).
Regarding claim 11, Jeffrey further discloses a neurostimulation system comprising the apparatus of claim 10 (e.g. Abstract; Claim 1).
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.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey et al. (International Publication WO 2023/069593), hereinafter Jeffrey, as applied to claim 2 above, and further in view of Chetelat (US Patent Application Publication 2021/0401317).
Regarding claim 4, Jeffrey fails to disclose wherein the modulated electrical stimulation signal is a modulated constant current square wave electrical stimulation signal. Chetelat, in a similar field of endeavor, is directed towards a sensor device for impedance measurement. Chetelat discloses using a modulated constant current square wave electrical stimulation signal (e.g. Par. [0052]: current is applied as a square wave).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Jeffrey to include the square wave as taught by Chetelat because doing so would allow better assessment of the quality of electrode contact (e.g. Chetelat, par. [0052]).
Regarding claim 5, Jeffrey fails to disclose wherein the method further comprises measuring the voltage of the stimulation signal applied via the constant current square wave electrical stimulation signal to estimate the simplified impedance via the simplified model at any given point in the wave. Chetelat, in a similar field of endeavor, is directed towards a sensor device for impedance measurement. Chetelat discloses measuring the voltage of the stimulation signal applied via the constant current square wave electrical stimulation signal to estimate the simplified impedance via the simplified model at any given point in the wave (e.g. Par. [0052]: current is applied as a square wave and impedance is measured).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Jeffrey to include measuring the impedance as taught by Chetelat because doing so would allow better assessment of the quality of electrode contact (e.g. Chetelat, par. [0052]).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey et al. (International Publication WO 2023/069593), hereinafter Jeffrey, further in view of Chetelat (US Patent Application Publication 2021/0401317), as applied to claim 5 above, and further in view of Grant et al. (US Patent Application Publication 2019/0343462), hereinafter Grant.
Regarding claim 6, Jeffrey fails to disclose wherein measuring the voltage of the stimulation signal applied via the constant current square wave comprises calculating the impedance as a function of frequency. Grant, in a similar field of endeavor, is directed towards determining connection quality of electrodes. Grant discloses calculating the impedance as a function of frequency (e.g. Pars. [0124]-[0129]: using FFT to determine impedance).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Jeffrey in view of Chetelat to include calculating impedance as a function of frequency as taught by Grant because doing so would allow determination of the most accurate impedance (e.g. Grant, par. [0129]).
Regarding claim 7, Jeffrey fails to disclose wherein calculating the impedance as a function of frequency comprises implementing a Fourier transform. Grant, in a similar field of endeavor, is directed towards determining connection quality of electrodes. Grant discloses implementing a Fourier transform (e.g. Pars. [0124]-[0129]: using FFT to determine impedance).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Jeffrey in view of Chetelat to include calculating impedance as a function of frequency as taught by Grant because doing so would allow determination of the most accurate impedance (e.g. Grant, par. [0129]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey et al. (International Publication WO 2023/069593), hereinafter Jeffrey, as applied to claim 1 above, and further in view of Van Ingelgem et al. (US Patent Application Publication 2022/0003704), hereinafter Van Ingelgem.
Regarding claim 8, Jeffrey fails to disclose wherein configuring the controller to assess changes in impedance of the system comprises implementing one or more lookup tables that correlate hydrogel pad condition with system impedance. Van Ingelgem, in a similar field of endeavor, is directed towards a smart sensing system. Van Ingelgem discloses implementing one or more lookup tables that correlate hydrogel pad condition with system impedance (e.g. Par. [0087]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Jeffrey to include the lookup tables as taught by Van Ingelgem, because doing so would allow a determination of the condition of the electrode.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey et al. (International Publication WO 2023/069593), hereinafter Jeffrey, further in view of Van Ingelgem et al. (US Patent Application Publication 2022/0003704), hereinafter Van Ingelgem, as applied to claim 8 above, and further in view of Grant et al. (US Patent Application Publication 2019/0343462), hereinafter Grant.
Regarding claim 9 Jeffrey fails to disclose wherein implementing one or more lookup tables that correlate hydrogel pad condition with static system impedance is determined as a function of frequency. Grant, in a similar field of endeavor, is directed towards determining connection quality of electrodes. Grant discloses calculating the impedance as a function of frequency (e.g. Pars. [0124]-[0129]: using FFT to determine impedance).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Jeffrey in view of Van Ingelgem to include calculating impedance as a function of frequency as taught by Grant because doing so would allow determination of the most accurate impedance (e.g. Grant, par. [0129])
Conclusion
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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