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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are 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.
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.
Claim 10 is 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 10 recites the limitation “mapping stage” and “an integration stage” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Additionally, regarding claim 10, the phrase "may be" renders the claim(s) indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 1-16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bloch et al. (US 20170173326 A1).
As to claim 1, Bloch et al. discloses a method for providing neuromodulation for spinal cord injury (SCI) treatment of a patient ([0005, 0074, 0106]) comprising: providing neuromodulation to a cervical spinal cord of a patient ([0064, 0103-0104, 0154]) via at least one neuromodulator (IPG, [0121-0122]) and at least one dorsal neuromdulation array (Abstract, [0039, 0064, 0080, 0103]), wherein the patient has SCI ([0036, 0106]); measuring movements and/or muscle activations of the patient via at least one sensor ([0049, 0085, 0089, 0124-0125, 0129]); implementing a mapping between desired muscle activation patterns and neuromodulation parameters via at least one mapping module ([0124, 0128-0129]; “By recording neural activity following a prompt for the motor task, modulation of the neural responses of the subject to attempting the motor task may be used by algorithms 153 of signal processing device 150 to establish a model that maps neural activity to motor task attempts, which may be used to detect motor task attempts from neural activity. In this way, the motor task is employed to detect neural activity congruent with volitional movement execution”. [0124] and “Signal processing device 150 may include one or more algorithms 153 for analyzing various signals received by signal processing device 150”[0129]; the examiner considers, under the broadest reasonable interpretation, the algorithms (depicted as 153 in Figure 11) to be the “mapping module” since the algorithms “map desired muscle activation patterns and neuromodulation parameters”. Furthermore, Applicant recites “the mapping module and the processing module may be embodied in the same microcontroller or computer”[0045]); and via at least one processing module (signal processing device, depicted as 150; [0129]): processing signals provided by the at least one sensor ([0086, 0129]), forwarding the processed signals to the at least one mapping module ([0095, 0124, 0128-0129]), and directing a mapping module output to the neuromodulator ([0040-0043, 0087, 0129]).
As to claims 2 and 20, Bloch et al. discloses the at least one neuromodulator is a neurostimulator (Abstract, [0066]).
As to claim 3, Bloch et al. discloses providing neurostimulation in at least three channels independently via the neurostimulator ([0031, 0173]; “the IPG of the present disclosure is able to deliver independent amounts of current to multiple electrodes simultaneously, thus controlling independent current sources”[0173]; thus the IPG is a multi-channel neurostimulator with at least three channels).
As to claim 4, Bloch et al. discloses providing neurostimulation in a frequency range from 0-1000 Hz via the neurostimulator ([0130, 0163]).
As to claim 5, Bloch et al. discloses the at least one neuromodulator is at least partially implanted ([0130]; since the neuromodulator, IPG, is implanted it is “at least partially” implanted).
As to claim 6, Bloch et al. discloses the at least one neuromodulator is fully implanted ([0121, 0130]).
As to claim 7, Bloch et al. discloses the at least one dorsal neuromodulation array is a dorsal neurostimulation array (Abstract, [0039, 0056, 0061, 0064, 0080, 0103]).
As to claim 8, Bloch et al. discloses the at least one dorsal neuromodulation array has a plurality of active sites E, wherein the active sites E are placed in a region of approx. 2-25 mm from a midline of the patient's spinal cord ([0101]; Since Bloch et al. discloses “a plurality of active sites E”, the examiner considers those “active sites E” of Bloch et al. to necessarily include being “placed in a region of approx. 2-25 mm from a midline of the patient's spinal cord”).
As to claim 9, Bloch et al. discloses the neuromodulation is a neuromodulation for selective muscle activation ([0017, 0056, 0072, 0089, 0197, 0277, 0280]).
As to claim 10, as best understood in light of the rejection under 35 U.S.C. 112 above, Bloch et al. discloses a mapping stage and an integration stage may be encompassed by a same computer/microcontroller and that one or both are external to the patient, partially implanted or fully implanted ([0065, 0087-0088]).
As to claim 11, Bloch et al. discloses the neuromodulation is configured and arranged to target posterior roots ([0022-0027]).
As to claim 12, Bloch et al. discloses the at least one dorsal neuromodulation array has a plurality of active sites E, wherein the active sites E are placed in a region of approx. 4-10 mm from a midline of the patient's spinal cord ([0101]; Since Bloch et al. discloses “a plurality of active sites E”, the examiner considers those “active sites E” of Bloch et al. to necessarily include being “placed in a region of approx. 4-10 mm from a midline of the patient's spinal cord”).
As to claim 13, Bloch et al. discloses the SCI treatment of the patient is neurostimulation ([0074, 0106, 0122]).
As to claim 14, Bloch et al. discloses the neuromodulation is provided to the cervical spinal cord for the SCI treatment of the patient, and wherein the patient has an SCI condition ([0154, 0228]).
As to claim 15, Bloch et al. discloses the SCI condition interrupts communication between a spinal cord and supraspinal centres of the patient ([0005, 0036, 0074, 0228-0229]).
As to claim 16, Bloch et al. discloses comprising measuring the muscle activations via the at least one sensor ([0049]), and using the measured muscle activations to implement the mapping between the desired muscle activation patterns and the neuromodulation parameters ([0198-0199]).
As to claim 18, Bloch et al. discloses carrying out a calibration step ([0198-0199]). As to the “online stimulation selection step”, in absence of any definition or parameters for what constitutes as an “online stimulation selection step”, under the broadest reasonable interpretation, the examiner considers the application of stimulation ([0065, 0080, 0089])
of Bloch et al. to be the “online stimulation selection step”.
As to claim 19, Bloch et al. discloses the calibration step includes implanting an electrode of the at least one neuromodulator and delivering single pulse epidural electrical stimulation (EES) at different amplitudes during the implantation to map motoneuronal activations ([0055, 0089, 0223, 0265, 0295])
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.
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 17 is rejected under 35 U.S.C. 103 as being unpatentable over Bloch et al. (US 20170173326 A1). Bloch et al. discloses the invention substantially as claimed with mapping muscle activations to guide stimulation parameter selection for the neuromodulation ([0056, 0088-0089]) but does not explicitly disclose the generation or construction of a template. It would have been obvious to one having ordinary skill in the art at the time the invention was made to create a stimulation template, since template generation and implementation is extremely well known in the electrical stimulation therapy art. Furthermore, implementing a template would provide the predictable results of ensuring specific modifications to explicitly meet patient’s therapeutic needs and requirements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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, David E Hamaoui can be reached at (571) 270-5625. 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.
/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
Prosecution Insights