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 .
Election/Restrictions
Based on the response to the restriction requirement several claims have been cancelled.
The pending claims include 1-4, 7, 9-10, 13, 15, 18-19, 31-34 and 36-45.
IDS
Applicant should note that the large number of references in the attached IDS have been considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the filter circuitry (claim 10), a time window (claim 32), a stimulation signal (claim 32), the cloud (claim 43), a rechargeable battery (claim 44) and a capacitor (claim 45) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 33 recites “the transfer” this language lacks proper antecedent basis and should read “a transfer”. Claim 33 also recites “the location” in lines 4 and 5, each recitation of “the location” lacks proper antecedent basis and should recite “a location”.
Claim 43 is objected to because of the following informalities: the language “the cloud” lacks proper antecedent basis and should read “a cloud”.
Appropriate correction is required.
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 32-34 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 32 recites “estimating a time window where a stimulation signal is delivered by the stimulation set of electrodes arrives at the sense/recording set of electrodes.” This language is indefinite because, as is known, the stimulation signal itself does not “arrive” at the sense/recording electrodes. The sense/recording electrodes sense/record a neural response (ECAP) which is a response to the stimulation signal.
Claim 33 recites “estimating a speed of the transfer of an activated neural signal from the location of stimulation set of electrodes in the location of the sensing/recording set of electrodes”. This language is indefinite and confusing. It is unclear what applicant intends “the transfer of an activated neural signal” to be. As discussed with claim 32 the stimulation creates an action potential that travels from the stimulation electrode to the sensing electrode, there is no transfer.
Claim Rejections - 35 USC § 102
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 1-2, 4, 7, 19, 31, 36-38, 42 and 44-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jenison et al. US 2018/0209848.
Regarding claim 1: Jenison discloses an implantable treatment device 12A/12B/12 (figures 1A/1B/2), comprising:
an energy harvesting circuit 14A/14B/56B/64 (figure 2 the energy harvesting circuit it considered to include the coils 14A/14B connected to switching circuitry 56B which powers the power source 64) the harvesting circuitry harvests electromagnetic energy (abstract, paragraphs 0021, 0033 and 0039);
a sensing circuit (paragraphs 0019, 0024 “sensing circuitry”) that senses bioelectrical signals and generates bioelectrical signal data (“action potentials”, paragraph 0025);
a stimulator circuit 50 (figure 2) coupled to electrodes 22 (figure 2); the stimulator circuitry delivers therapy/stimulation (paragraphs 0029-30), the electrodes include 22A-22D which can be considered a set, control signals from an external controller are also disclosed (paragraphs 0004, 0024-25 and 0030-31);
a communication circuit 54 (figure 2) to transmit to the external controller the sensed bioelectrical signals and control the stimulator circuit to delivery energy to the electrodes in response to the control signal received from the external controller (paragraphs 0030-31).
Regarding claim 2: Jenison discloses that the bioelectrical signals are neural signals (paragraph 0025 “neurological signals” “action potentials”).
Regarding claim 4: Jenison discloses that the bioelectrical signal data is used to optimize parameters for stimulation (paragraphs 0030- 0031).
Regarding claim 7: Jenison discloses that the device uses sensed signals to control stimulation (paragraphs 0025, 0031; “Processing circuit 52 may transmit operational information to and receive stimulation programs or therapy parameter adjustments from programmer 30 via coils 14A and telemetry circuit 54”.) This is considered to be feedback and/or closed-loop stimulation.
Regarding claim 19: Jensen discloses feedback stimulation which is considered to be using data derived from a specific patient (paragraphs 0025, 0031).
Regarding claim 31: Jenison discloses;
sensing, through an implantable treatment device 12A/12B/12 (figures 1A/1B/2), bioelectrical activity (paragraphs 0019, 0024-25);
transmitting, through the implantable treatment device, the bioelectrical data corresponding to sensed bioelectrical activity to an external controller (paragraphs 0018, 0021,0031-32);
receiving, through the implantable device, stimulation control data derived from the bioelectrical data by the external controller (paragraphs 0004, 0024-25 and 0030-31); and
delivering, through the implant, stimulation based on the stimulation control data (paragraphs 0004, 0024-25 and 0030-31).
Regarding claim 36: Jenison discloses that the plurality of parameters include voltage amplitude, a current amplitude, a pulse rate, a pulse width, a duty cycle, or the combination of electrodes (paragraph 0030).
Regarding claim 37: Jenison discloses that the external controller processes the bioelectrical signal data to generate control signals (paragraphs 0026, 0030-31).
Regarding claim 38: Jenison discloses inductive coupling for receiving power (paragraph 0018), inductive charging is shown in figure 1B and is considered to be wireless powering the device.
Regarding claim 42: Jenison discloses that the stimulator circuitry stimulates spinal cord (paragraphs 0002, 0011) and brain tissue (figure 1A) which is central nervous system tissue.
Regarding claim 44: Jenison discloses that the energy harvesting circuit includes a rechargeable battery 64 (figure 2, paragraphs 0003, 0005 and 0018).
Regarding claim 45: Jenison discloses that the energy harvesting circuit can include a capacitor or a battery (paragraph 0036). Jenison further discloses that the coils, which are part of the energy harvesting circuit can also include capacitors (paragraph 0046).
Claim Rejections - 35 USC § 103
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.
Claims 3, 10 and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Jenison et al. US 2018/0209848 in view of Marceglia et al. US 2020/0188675.
Regarding claim 3: Jenison discloses the claimed invention including a digital signal processor (paragraph 0029). However, Jenison is silent as to the sensing circuit digitizing the sensed (bioelectrical) signals. Marceglia however teaches of sensing circuitry to measure local field potentials (LFPs). The sensing circuitry analyzes the LFPs, the analysis includes analog-to-digital conversion which would result in digitizing the LFPs (paragraph 0034). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include a sensing circuit with an ADC to convert the analog signal to a digital format, as taught by Marceglia, in order to allow for computational analysis of the signals (Marceglia paragraph 0034).
Regarding claim 10: Jenison discloses the claimed invention however, Jenison does not disclose the use of filter circuitry prior to analog-to-digital conversion of the sensed signals. Marceglia however, teaches of a sensing module with one or more filters to remove unwanted artifacts, once the artifacts are removed the filtered LFP is then digitized (paragraph 0034). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include filter circuitry prior to analog-to-digital conversion, as taught by Marceglia, in order to “calculate or otherwise determine electrical stimulation parameters based on the acquired neural activity signals”(Marceglia, paragraph 0034).
Regarding claim 39: Jenison discloses the claimed invention however, Jenison does not disclose the use of a filter designated to pass 0.1Hz-10 kHz. Marceglia however teaches of a band pass filter which passes 2-7 or 8-12 Hz signals (paragraph 00622). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include a band pass filter which allows 2-7 or 8-17 Hz to pass, as taught by Marceglia, in order to monitor neural LFP’s.
Regarding claim 40: Jenison discloses the claimed invention, Marceglia disclose the use of a band pass filter which would necessarily filter out noise signals. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include the band pass filter to filter out noise, as taught by Marceglia, in order to focus on the sensed signal.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jenison et al. US 2018/0209848 in view of Dinsmoor et al. US 2019/0388692.
Regarding claim 9: Jenison discloses measuring action potentials in the brain. However, Jenison does not discuss or disclose that the action potentials range from 1µV- 100mV. Dinsmoor however teaches of measuring evoked compound action potentials (ECAPs) which range from 0.15-.25 mV. The ECAPs are used for feedback stimulation (paragraph 0147). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include measuring ECAPs which range from 0.15-.25 mV, as taught by Dinsmoor, in order to use the ECAP as feedback for neural stimulation (Dinsmoor, paragraph 0147).
Claims 13, 15 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Jenison et al. US 2018/0209848 in view of Esteller et al. US 2019/0366094.
Regarding claim 13: Jenison discloses the claimed invention however Jenison does not disclose that the bioelectrical signals are sensed within a predetermined time window ranging from 1µs – 100 ms after stimulation. Esteller however teaches of a neurostimulation device and method which use a delay 130 (figures 7A-7B) after stimulation to begin sensing the ECAP signal. The delay is 0.4 ms (paragraph 0048). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include a delay of 0.4 ms after stimulation prior to sensing an ECAP, as taught by Esteller, in order to avoid stimulation artifact in the sensed ECAP.
Regarding claim 15: Jenison discloses the claimed invention however Jenison does not disclose sensing in an intermittent fashion creating a duty cycle of less than 20%. Esteller however teaches of measuring/sensing ECAP signals. In the Esteller disclosure it is taught that sensing of the ECAP is enabled on electrode E8 (figure 7) after a delay 130 (figure 7). The sensor would only be on during sensing. Sensing lasts up to 3 ms. As can be seen in figures 11A and 11B the ECAP lasts from 1.0 ms to just under 2.0 ms. The sensor is only on for this 1 ms time frame and then the sensor is disabled. This creates a duty cycle of 20%. However, the duty cycle would likely be lower than 20% because the stimulation artifact also lasts for 1 ms, thus creating a duty cycle of approximately 17%. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include a sensing duty cycle of less than 20%, as taught by Esteller, in order to reduce power consumption.
Regarding claim 41: Jenison discloses the claimed invention however Jenison does not disclose that the bioelectrical signals are sensed within a predetermined time window ranging from 1µs – 100 ms after stimulation. Esteller however teaches of a neurostimulation device and method which use a delay 130 (figures 7A-7B) after stimulation to begin sensing the ECAP signal. The delay is 0.4 ms (paragraph 0048). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include a delay of 0.4 ms after stimulation prior to sensing an ECAP, as taught by Esteller, in order to avoid stimulation artifact in the sensed ECAP.
Claims 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Jenison et al. US 2018/0209848 in view of Zhu et al. US 2019/0275331.
Regarding claim 32 as understood: Jenison discloses the claimed invention however Jenison does not disclose stimulation electrodes spaced apart from recording electrodes, estimating a time window for the arrival of a neural response, determining an arrival time based on the estimated window and sensing neural signals according to the determined time. Zhu however teaches of feedback neural stimulation based on sensed ECAP signals. In the Zhu disclosure the stimulation electrode Estim (figure 9) is used to stimulate the spinal cord tissue, this signal is then recorded at E3, E6 and E8. With reference to Zhu figures 7A and 7B stimulation is applied between electrodes E3, E4 and E5 creating the field 92 (figure 7A), the ECAP travels down the electrode lead and is then sensed at E8. The ECAP begins at time=0 and arrives at E8 after delay 130 (figure 7B), the arrival is based on the speed of travel, the ECAP passes E8 at approximately 0.4 ms, the ECAP algorithm starts sensing before 0.4 ms. In this case the time to initiate sensing begins based on the delay window 130. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include estimating a time window, considered to be the delay, using the time window to determine when the ECAP will arrive at the sense electrode and initiate sensing accordingly. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include estimating a time window as well as a time of arrival for the ECAP and initiating sensing based on the time or arrival, as taught by Zhu, in order to sense the ECAP without interference from the artifact.
Regarding claim 33 as understood: Jenison discloses the claimed invention however Jenison does not disclose stimulation electrodes spaced apart from recording electrodes, estimating a time window for the arrival of a neural response, determining an arrival time based on the estimated window and sensing neural signals according to the determined time. Zhu however teaches of feedback neural stimulation based on sensed ECAP signals. In the Zhu disclosure the stimulation electrode Estim (figure 9) is used to stimulate the spinal cord tissue, this signal is then recorded at E3, E6 and E8. With reference to Zhu figures 7A and 7B stimulation is applied between electrodes E3, E4 and E5 creating the field 92 (figure 7A), the ECAP travels down the electrode lead and is then sensed at E8. The ECAP begins at time=0 and arrives at E8 after delay 130 (figure 7B), the arrival is based on the speed of travel, the ECAP passes E8 at approximately 0.4 ms, the ECAP algorithm starts sensing before 0.4 ms. In this case the time to initiate sensing begins based on the delay window 130. Zhu further teaches that the speed of the ECAP is 5 cm/ 1 ms (paragraph 0048). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include using the speed of propagation of the ECAP signal in order to determine timing of the sensing, as taught by Zhu, in order to appropriately sense the ECAP signal.
Regarding claim 34 as understood: Jenison discloses the claimed invention however Jenison does not disclose stimulation electrodes spaced apart from recording electrodes, estimating a time window for the arrival of a neural response, determining an arrival time based on the estimated window and sensing neural signals according to the determined time. Zhu however teaches of feedback neural stimulation based on sensed ECAP signals. In the Zhu disclosure the stimulation electrode Estim (figure 9) is used to stimulate the spinal cord tissue, this signal is then recorded at E3, E6 and E8. With reference to Zhu figures 7A and 7B stimulation is applied between electrodes E3, E4 and E5 creating the field 92 (figure 7A), the ECAP travels down the electrode lead and is then sensed at E8. The ECAP begins at time=0 and arrives at E8 after delay 130 (figure 7B), the arrival is based on the speed of travel, the ECAP passes E8 at approximately 0.4 ms, the ECAP algorithm starts sensing before 0.4 ms. In this case the time to initiate sensing begins based on the delay window 130. Zhu further teaches that the processing of the ECAP signals can occur within an external controller, this would require the ECAP to be transmitted to the external controller and making the appropriate adjustments to stimulation based on the ECAP (paragraphs 0076-77). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include measuring ECAPs and transmitting the ECAP to an external programmer for analysis and stimulation adjustment in a feedback manner, as taught by Zhu, in order to apply feedback stimulation to the patient based on the measured ECAP signal.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Jenison et al. US 2018/0209848 in view of Moffitt et al. US 2020/0046980.
Regarding claim 18: Jenison discloses the claimed invention however Jenison does not specifically disclose the use of population data for optimizing stimulation. Moffitt however teaches of using data from different patients (paragraph 0155). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include using parameters extracted from population data, as taught by Moffitt, in order to determine appropriate pulse widths for stimulation (Moffitt, paragraph 0155).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Jenison et al. US 2018/0209848 in view of Block et al. US 2020/0376272.
Regarding claim 43: Jenison discloses the claimed invention however Jenison does not disclose processing in a cloud. Block however teaches of cloud computing which would be data processing in the cloud (paragraph 0155). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Jenison to include cloud computing, as taught by Block, in order to process the data.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Single et al. US 2021/0008373 discloses a neural stimulation circuit for sensing neural responses and using the neural response as feedback (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796