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 Objections
Claim 8 is objected to because of the following informalities: “…includes a patient responses…” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 11 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification does not state how the machine learning model is trained to learn for the determining the signal processing or to any known trained machine learning model. The specification only states using a trained machine learning model.
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.
Claim(s) 14-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The judicial exception being an abstract idea. The claim(s) recite(s) sensing a physiological signal, collecting patient condition or contextual information, determining a signal processing parameter, processing the sensing physiological signal, and providing a control signal based at least in part on a signal feature of the processed physiological signal similar to Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) which was directed to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea. This judicial exception is not integrated into a practical application because when the claims are considered as a whole, there is no element or combination of elements in the claims that are sufficient to ensure that the claims amount to significantly more that the abstract idea itself. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims fail to recite any improvements to another technology or technical field, improvements to the functioning of the processor itself, and/or meaningful limitation beyond generally link the use of an abstract idea to a particular environment. The use of a sensing circuit is merely generic. Therefore, because there is no meaningful limitations in the claim to transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself, the claim is rejected under 35 USC 101 as being directed to non-statutory subject matter.
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.
Claim(s) 1, 4-8, 11-14, 17, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamann et al. (US 20110282416).
Regarding claim 1, Hamann discloses a system 600, 606 for providing electrostimulation to a patient (Fig. 6), the system comprising:
an electrostimulation circuit 610 configured to provide a neuromodulation therapy to the patient (Fig. 6, section 0039);
a sensor circuit 607, 611, 614 configured to sense a physiological signal from the patient (Fig. 6 section 0039), and to collect patient condition 607 or contextual information 614 associated with the sensing of the physiological signal (section 0039);
and a controller circuit 612, configured to:
determine a signal processing parameter 611 based at least on the collected patient condition or contextual information (Fig. 6, section 0039);
process the sensed physiological signal using the determined signal processing parameter (section 0039, A feedback detection circuit 611 receives the signal indicative of the response and processes the signal to provide a neural stimulation feedback signal);
and generate a control signal 613 to the electrostimulation circuit 610 to adjust the neuromodulation therapy based at least in part on a signal feature of the processed physiological signal (Fig. 6, section 0039, the therapy titration/adjustment module 613 uses the feedback signal to modulate or titrate the therapy generated by the stimulation output circuit 610 to provide the desired physiologic response).
Regarding claim 4, Hamann discloses
the patient condition or contextual information includes a time of day or night when the physiological signal is sensed (Sections 0026, 0037).
Regarding claim 5, Hamann discloses
the patient condition or contextual information includes medication or a change of medication of the patient (Section 0026, 0036, 0057).
Regarding claim 6, Hamann discloses
the controller circuit is coupled to a sleep detector configured to sense the patient condition or contextual information including a sleep state or an awakening state of the patient when the physiological signal is sensed (Sections 0047, 0055, 0063).
Regarding claim 7, Hamann discloses
the controller circuit is coupled to an activity sensor configured to sense the patient condition or contextual information including a physical activity level when the physiological signal is sensed (section 0039, Examples of contextual inputs include an activity sensor).
Regarding claim 8, Hamann discloses
the patient condition or contextual information includes a patient responses to neuromodulation therapy (Section 0039, The system 606 includes a data sensor 607 adapted to sense a physiologic response to the neural stimulation).
Regarding claim 11, Hamann discloses
the controller circuit is configured to determine the signal processing parameter using a trained machine learning model (Section 0064).
Regarding claim 12, Hamann discloses
the sensed physiological signal includes electrical signals sensed respectively from at least two brain regions in response to neuromodulation therapy delivered to a brain stimulation site, wherein the controller is configured to determine the signal feature including a phase-amplitude coupling or a coherence between the electrical signals sensed respectively from the at least two brain regions, and to adjust the neuromodulation therapy based at least in part on the determined phase-amplitude coupling or the coherence between the electrical signals.
Regarding claim 13, Hamann discloses
an ambulatory medical device, 600 comprising the electrostimulation circuit 610 and a programmable signal processing module 611 for processing the physiological signal (Fig. 6, section 0039); and
a programmer device 937 in operative communication with the ambulatory medical device 934 (Fig. 9), the programmer device 937 comprising a user interface to receive a user input to modify the programmable signal processing module of the ambulatory medical device with the signal processing parameter (Fig. 9, Section 0059).
Regarding claim 14, Hamann discloses providing neuromodulation therapy 600, 606 to a patient via an electrostimulator 610 (Fig. 6), the method comprising:
sensing a physiological signal from the patient using a sensor circuit 607, 611, 614 (Fig. 6 section 0039);
collecting patient condition 607 or contextual information 614 associated with the sensing of the physiological signal (Fig. 6 section 0039);
determining a signal processing parameter 611 based at least on the collected patient condition or contextual information (Fig. 6, section 0039);
processing the sensed physiological signal using the determined signal processing parameter (section 0039, A feedback detection circuit 611 receives the signal indicative of the response and processes the signal to provide a neural stimulation feedback signal); and
providing a control signal 613 to the electrostimulator 610 to adjust the neuromodulation therapy based at least in part on a signal feature of the processed physiological signal (Fig. 6, section 0039, the therapy titration/adjustment module 613 uses the feedback signal to modulate or titrate the therapy generated by the stimulation output circuit 610 to provide the desired physiologic response).
Regarding claim 17, Hamann discloses
the patient condition or contextual information includes at least one of: a time of day or night when the physiological signal is sensed (Sections 0026, 0037);
medication or a change of medication of the patient (Section 0026, 0036, 0057);
a sleep state or an awakening state of the patient when the physiological signal is sensed (Sections 0047, 0055, 0063);
a physical activity level when the physiological signal is sensed (section 0039, Examples of contextual inputs include an activity sensor); or
a patient responses to neuromodulation therapy (Section 0039, The system 606 includes a data sensor 607 adapted to sense a physiologic response to the neural stimulation).
Regarding claim 19, Hamann discloses
determining the signal processing parameter includes using a trained machine learning model (Section 0064).
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.
Claim(s) 20 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Hamann et al. (US 20110282416) as applied to claim 14 above, and further in view of Giftakis (US 20110137371). Hamann discloses the invention substantially as claimed however does not show the sensed physiological signal includes electrical signals sensed respectively from at least two brain regions in response to neuromodulation therapy delivered to a brain stimulation site, wherein the signal feature used for adjusting the neuromodulation therapy includes a phase-amplitude coupling or a coherence between the electrical signals sensed respectively from the at least two brain regions.
Giftakis discloses the sensed physiological signal includes
electrical signals sensed respectively from at least two brain regions in response to neuromodulation therapy delivered to a brain stimulation site (Fig. 1, section 0042, anterior thalamic nucleus, hippocampus, frontal cortex), wherein the signal feature used for adjusting the neuromodulation therapy includes a phase-amplitude coupling (Section 0089) or a coherence between the electrical signals sensed respectively from the at least two brain regions (Section 0125-0126). This allows for a functional relationship between the two different brain regions by evoking a response in one area by stimulating the other.
Therefore it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Hamann by adding the sensed physiological signal includes electrical signals sensed respectively from at least two brain regions in response to neuromodulation therapy delivered to a brain stimulation site, wherein the signal feature used for adjusting the neuromodulation therapy includes a phase-amplitude coupling or a coherence between the electrical signals sensed respectively from the at least two brain regions as taught by Giftakis in order to facilitate a functional relationship between the two different brain regions by evoking a response in one area by stimulating the other.
Allowable Subject Matter
Claims 9-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
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