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 § 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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1
The claims are drawn to a devices (Claims 1 and 7) and methods (Claim8
Step 2A, Prong 1
Claim 1 recites the steps of “determine a threshold value…” and “determine a stimulation intensity…”. Claims 7 and 8 likewise include these steps. The steps are broadly claimed and amount to mental/ pen-and-paper determinations that a clinician could make from reviewing sensed data. A clinician could review data; make mental calculations of a threshold; and make mental notes of new parameters that could be sued based on those thresholds. Therefore, the claims recite mental process abstract ideas.
Step 2A, Prong 2
The claims do not include any additional elements that amount to integration of the abstract idea into a practical application. Claim 1 includes the additional elements of an implantable device for providing an initial stimulus; a controller to receive a sensed signal; and a determiner to determine a stimulation intensity. The generic claim of an implantable device amounts to generically linking the abstract idea to another technological environment or field of use; the initial application of stimulation is performed in order to gather data for the mental analysis step and thus amounts to insignificant extra-solution activity (see MPEP §2106.04(d)(2), c); receiving the data is insignificant extra-solution activity (mere data gathering) and the “determiner” is generic computer structure (a processor) on which the abstract idea is implemented. Claim 7 incorporates the same additional elements via its dependency on claims 6 and 1. Claim 8 includes the additional elements of electrically stimulating the nerve to set up the environment in which the data is gathered (insignificant extra-solution activity) and measuring ECAPs (data gathering). Insignificant extra-solution activity; generic computer implementation and generically linking the abstract idea to another technological environment of field of use do not integrate the abstract idea into a practical application.
Step 2B
The claims do not include any additional elements that amount, alone or in combination, to significantly more than the abstract idea itself. Claim 1 includes the additional elements of an implantable device for providing an initial stimulus; a controller to receive a sensed signal; and a determiner to determine a stimulation intensity. The generic claim of an implantable device amounts to generically linking the abstract idea to another technological environment or field of use; the initial application of stimulation is performed in order to gather data for the mental analysis step and thus amounts to insignificant extra-solution activity (see MPEP §2106.04(d)(2), c); receiving the data is insignificant extra-solution activity (mere data gathering) and the “determiner” is generic computer structure (a processor) on which the abstract idea is implemented. Claim 7 incorporates the same additional elements via its dependency on claims 6 and 1. Claim 8 includes the additional elements of electrically stimulating the nerve to set up the environment in which the data is gathered (insignificant extra-solution activity) and measuring ECAPs (data gathering). Insignificant extra-solution activity; generic computer implementation and generically linking the abstract idea to another technological environment of field of use do not, alone or in combination, amount to significantly more than the abstract idea itself.
Claims 2, 3, 6 and 10 only further generically link the abstract idea to another technological environment or field of use.
Claims 4, 5, 9 and 11 only further introduce abstract idea limitations (mental processes and mathematical concepts).
The Examiner notes Claims 1, 7 and 8 do not ever require the determined stimulation intensities to be applied after they are determined. By amending the claims to actually require the application of the new parameters, the current rejection would likely be overcome.
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 4, 5 and 9-11 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.
Regarding claim 4, Applicant uses the term “integrates”. It is unclear if this is simply saying the controller broadly uses the ECAP value (e.g. integrates it into the analysis of the stimulation response) or if Applicant means actually performing an integral of the ECAP waveform (an area under the curve measure of the response). The metes and bounds of the claim are unclear.
Claims 4 and 5 include limitations that are not clearly tied to the functional steps f Claim 1. Claim 4 requires either broadly integrating the ECAP into the function of claim 1 or performing an actual integral and Claim 5 requires determining a point according to a second derivative. However, Claims 4 and 5 do not have any limitations indicating how these values are used with eh system and Claim 1 does not have any clear language how these values are used by the controller or stimulation determiner. Are these values used to determine a threshold value? Are these values the values that are compared to the threshold value?
The term “significant increase” in claims 5 and 9 is a relative term which renders the claim indefinite. The term “significant increase” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what level of increase is considered by Applicant to be significant versus insignificant.
Claim 5 recites the limitation "the second derivative" and “the previous result”. There is insufficient antecedent basis for these limitations in the claim.
Claim 9 also has the same issue as claim 4.
Claims 10 and 11 are rejected due to their dependence on indefinite claim 9.
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, 4, 7 and 8 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Slopsema et al. (PGPUB 2023/0141622).
Regarding Claims 1, 4, 7 and 8, Slopsema discloses a device for targeting peripheral nerves (such as a tibial nerve to treat overactive bladder (par. [0025, 0081]), wherein the device has a housing with control and processing circuitry therein (par. [0029]) that receives sensed data forms sensors 50 (such as ECAP data); compares it to a threshold (such as a minimum threshold, see par. [0065]); and adjusts stimulation intensity based on the comparison value (par. [0030, 0081]).
Claims 1, 2, 4 and 6-8 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Esteller et al. (2019/0209844).
Regarding Claims 1, 2, 4 and 6-8, Esteller discloses treating overactive bladder by stimulating a peripheral nerve (par. [0095]). Esteller discloses an implantable device 100 with electrodes 16 attached thereto and processing circuitry 102 therein that receives ECAP signals from a nerve; determines an area-under-the-curve of the response (par. [0070, 0071, 0076]) and adjusts stimulation based on the value and its comparison to a threshold (par. [0090]).
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Corey et al. (2022/0008726).
Regarding Claims 1 and 2 , Corey discloses an implantable stimulation device 200 having a controller 210 for receiving ECAP data from sensors 222 and a determiner (stimulation circuitry 202) for adjusting stimulation intensity based on the detected ECAP (Fig. 2; par. [0027-0029]).
In regard to Claim 3, Corey discloses a wireless charging device 150 for providing power to the implantable device (par. [0046]).
Conclusion
The Examiner notes Claims 5 and 9-11 do not have any prior art rejections applied but are not in condition for allowance due to the 35 USC 101 and 112(b) rejections.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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