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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 28-32 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 28-30 are device claims that positively recite the human body. Particularly, Claim 28 states “one or more leads implanted proximate to the afferent nerves”. Applicant is therefore claiming the human body and portions of the human body with respect to the lead. To overcome the current rejection, the Examiner suggests amending the claim to read “comprises one or more leads adapted to be implanted proximate to the afferent fibres”.
Claims 29-32 further define the connection to the human body and thus stand rejected also.
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, 10-14, 17-23 and 25-33 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Weber et al. (2013/0253299).
Regarding Claims 1 and 27, Weber discloses a method and system for restoring movement to a spastic muscle group (par. [0050]) comprising measuring one or more spinal activity values associated with a movement (e.g. dorsal root ganglion activity, see par. [0058, 0099, 0114]); decoding the DRG signals to determine a time-varying neural activity pattern (par. [0099, 0104, 0113]); and performing spinal cord stimulation of one or more afferent fibers associated with the muscle group to enable muscular activity assisting the movement, wherein the SCS is modulated according to the neural activity pattern (par. [0085]).
In regards to Claims 10-12, Weber discloses extracting activity values, i.e. spikes and particularly the burst duration of the spikes, associated with the movement and determining a pattern of the spikes using a regression model (par. [0110-0114]).
Regarding Claims 13, 14, 25 and 26, Weber discloses fine-tuning regression coefficients of the model using four identified gate states in a training phase (i.e. a calibration phase), see par. [0098-0099])..
In regards to Claims 17-20, Weber discloses generating a spinal activity graph and determining representative inhibitory and excitatory response levels from the graph (Fig. 3B, 10, 12A). Local maxima and minima are evident in the graphs and periods of excitation (hip-to-toe movement for instance in Fig. 10 and knee and ankle joint angular positions in Fig. 12A) and inhibition (no hip-to-toe movement in Fig. 10; flat line portions of Fig. 12A) are also evident, which also correspond to gait phases.
Regarding Claims 21-23, Weber discloses a configuration process that repeatedly applied stimuli; detected responses; and adjusted stimuli until the target recruitment level was obtained within a certain level of acceptability (stabilization) (par. [0097-0098]).
In regard to Claims 28-32, Weber discloses providing stimulation via electrode arrays that are capable of being implantable proximate the afferent nerves (par. [0024-0025, 0034]). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the leads of Weber are capable of the claimed placements due to their size (small enough to target an individual DRG, see Fig. 1) and thus anticipate the claim.
With regard to Claim 33, Weber discloses the processor is part of the stimulator (par. [0037]).
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 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Weber et al. (2013/0253299) in view of Parker (PGPUB 2017/0216587).
Regarding Claims 2-4, Weber discloses all of the claimed invention except for measuring non-evoked potentials and adjusting stimulation based on the non-evoked potentials. However, in the same field of endeavor of spinal cord simulation, Parker discloses measuring non-evoked potentials indicative of body movement for the purpose of adjusting stimulation to maintain effective nerve recruitment throughout movement of the patient (par. [0010-0011, 0079-0080]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Weber reference to include monitoring non-evoked potential s and adjusting stimulation according to the non-evoked potentials, as taught and suggested by Parker, for the purpose of adjusting stimulation to maintain effective nerve recruitment throughout movement of the patient.
In regard to Claim 5, Weber and Parker disclose the movement can be detected by an accelerometer (Parker: par. [0019]).
Claims 6-9, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Weber et al. (2013/0253299) in view of Grospretre et al. “ H reflex and spinal excitability: methodological considerations”.
Regarding Claims 6-9 and 24, Weber discloses providing stimulation to the spinal cord to aid in muscle contraction during movement but fails to disclose monitoring a degree of excitability of a stretch reflex of the muscle group at discrete sample times of the movement. However, concerned with the same problem of optimizing muscle recruitment during stimulation, Grospretre discloses recording reflex responses (H responses which are responses to excitation and thus excitation responses) and mapping stimulation pulses to the H responses for the purpose of optimizing H reflex responses and ensuring maximal muscle recruitment(see Abstract and p. 1654). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Weber reference to include monitoring stretch reflex of the muscle and optimizing therapy to the measured reflex, as taught and suggested by Grospretre, for the purpose of optimizing H reflex responses and ensuring maximal muscle recruitment.
Regarding Claim 25, Weber discloses fine-tuning regression coefficients of the model using four identified gate states in a training phase (i.e. a calibration phase), see par. [0098-0099]).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Weber et al. (2013/0253299) in view of Haggers (2009/0306491).
Regarding Claims 15 and 16, Weber discloses utilizing regression models to train the device on different gait states to optimize stimulation but fails to disclose using neural networks, particularly a hidden Markov model. However, in the same field of endeavor of spinal cord stimulation, Haggers discloses utilizing hidden Markov models to decode received information into usable information for the purpose of providing a computationally more efficient device (see par. [0054]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Weber reference to include a hidden Markov model, as taught and suggested by Haggers, for the purpose of providing a computationally more efficient device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Parker et al., U.S. Patent 9872990;
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
