DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claims 1 & 7 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 fails to reasonably convey to one skill in the art that the inventor had possession of a pulse stimulator that receives a “processed signal,” as the nature and processing of the signal are not sufficiently described;
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 1 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 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. In respect to the claim limitation “…a processed signal…” it is unclear as to what element is provided to provide said signal, i.e. there is no claimed element that sets forth how the processed signal is produced and is not properly set forth in the claim.
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 and 7 are rejected under 35 U.S.C. 101 because 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.
Claim 1 is 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).
Claim 1 recites the claim limitation(s), “…array of electrodes further sense EMG signals of the muscle target…” positively recites the human body. It is required to use language such as ‘configured to,’ ‘adapted for,’ etc.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hurtado (US 6,341,237) in view of Graupe et al. (US 5,070,873).
Hurtado discloses
1.
A neuromuscular stimulation system comprising: a neuromuscular cuff including an array of electrodes;
E.G. via the disclosed extremity cuff device for administrating electro-muscular stimulation (EMS 20 having a plurality of EMS electrodes 22 {[col 9, lines 1-6) & (Fig 1)}.
and a pulse stimulator which receives a processed signal and generates a pulse signal that is applied to the array of electrodes of the neuromuscular cuff to produce neuromuscular stimulation of a muscle target:
E.G. via the disclosed voltage/current source 500 that provides an electrical stimulation based an individual adjustment control 32 and then to each electrode 22 [(col 9, lines 59-67) & (Fig4)].
Hurtado discloses the claimed invention having a extremity cuff device for administrating electro-muscular stimulation EMS 20 having a plurality of EMS electrodes except wherein said plurality of EMS electrodes further sense EMG signals in order to provide closed loop neuromuscular stimulation of the muscle. Graupe et al. teaches that it is known to electrically stimulate a muscle by monitoring the EMG signal produced by the stimulated muscle and controlling one or more electrical stimulation parameters (col 4, lines 24-38).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device as taught by Hurtado with the monitoring of an EMG signal to control the stimulation parameters as taught by Graupe et al., since such a modification would provide the predictable results pertaining to effectively providing treatment specific to a particular muscular activity and in response to any changes being able to control the stimulation parameters (Graupe, col 4, lines 24-38).
2.
The neuromuscular stimulation system of claim 1, wherein the analysis of the sensed EMG signals of the muscle target to provide the closed loop neuromuscular stimulation of the muscle target includes turning individual electrodes of the array of electrodes on or off.
E.G. via the disclosed circuit 22 and blocking circuit 26 that separates EMG signals connected to the electrode 16, 17 and serv to block portions of the ES signal for producing a ‘blocked’ signal (Graupe, col 4, line 60-68) & (Fig 1)}.
3.
The neuromuscular stimulation system of claim 1, wherein the analysis of the sensed EMG signals of the muscle target further includes deciding whether to reposition the neuromuscular stimulation cuff.
E.G. via the disclosed means of electrically stimulating a muscle by monitoring the EMG signal produced by the stimulated muscle and controlling one or more electrical stimulation parameters (Graupe, col 4, lines 24-38).
AND
E.G. via the disclosed c extremity cuff 20 being selectively positioned (Hurtado, col 12, lines 14-33).
4.
The neuromuscular stimulation system of claim 1, wherein the muscle target comprises an arm, a forearm, or a wrist region and the neuromuscular cuff is configured to wrap around the arm, forearm, or wrist.
E.G. via the disclosed extremity cuff which stimulates the muscles in the arms (Hurtado, col 3, lines 53-56).
5.
The neuromuscular stimulation system of claim 1, wherein the processed signal comprises a non-stationary Poisson train with a modulated average pulse rate.
E.G. via the disclosed parameters of the ES signal (Graupe, col 3, lines 30-46).
6.
The neuromuscular stimulation system of claim 1, wherein the pulse signal comprises the processed signal converted into a waveform comprising monophasic and biphasic pulses.
E.G. (Graupe, col 3, lines 30-46).
7.
A neuromuscular stimulation method comprising: sensing electromyography (EMG) signals of a muscle target using an array of electrodes of a neuromuscular cuff; analyzing the sensed EMG signals to produce a processed signal
E.G. via the disclosed means of electrically stimulating a muscle by monitoring the EMG signal produced by the stimulated muscle and controlling one or more electrical stimulation parameters (Graupe, col 4, lines 24-38).
AND
E.G. via the disclosed extremity cuff device for administrating electro-muscular stimulation (EMS 20 having a plurality of EMS electrodes 22 [Hurtado, (col 9, lines 1-6) & (Fig 1)].
and generating a pulse signal that is applied to the array of electrodes of the neuromuscular cuff to produce neuromuscular stimulation of a muscle target using a pulse stimulator which receives the processed signal;
E.G. via the disclosed voltage/current source 500 that provides an electrical stimulation based an individual adjustment control 32 and then to each electrode 22 [Hurtado, (col 9, lines 59-67) & (Fig4)].
wherein the sensing, the analyzing, and the generating provides closed loop neuromuscular stimulation of the muscle target.
E.G. (Graupe, col 4, lines 24-38).
8.
The neuromuscular stimulation method of claim 7, wherein the closed loop neuromuscular stimulation of the muscle target includes turning individual electrodes of the array of electrodes on or off.
E.G. via the disclosed circuit 22 and blocking circuit 26 that separates EMG signals connected to the electrode 16, 17 and serv to block portions of the ES signal for producing a ‘blocked’ signal (Graupe, col 4, line 60-68) & (Fig 1)}.
9.
The neuromuscular stimulation method of claim 7, further comprising: analyzing the sensed EMG signals of the muscle target to decide whether to reposition the neuromuscular stimulation cuff.
E.G. via the disclosed means of electrically stimulating a muscle by monitoring the EMG signal produced by the stimulated muscle and controlling one or more electrical stimulation parameters (Graupe, col 4, lines 24-38).
AND
E.G. via the disclosed c extremity cuff 20 being selectively positioned (Hurtado, col 12, lines 14-33).
10.
The neuromuscular stimulation method of claim 7, wherein the muscle target comprises an arm, a forearm, or a wrist region.
E.G. via the disclosed extremity cuff which stimulates the muscles in the arms (Hurtado, col 3, lines 53-56).
11.
The neuromuscular stimulation method of claim 7, wherein the processed signal comprises a non-stationary Poisson train with a modulated average pulse rate.
E.G. via the disclosed parameters of the ES signal (Graupe, col 3, lines 30-46).
12.
The neuromuscular stimulation method of claim 1, wherein the generating of the pulse signal comprises converting the processed signal into a waveform comprising monophasic and biphasic pulses.
E.G. (Graupe, col 3, lines 30-46).
13.
A neuromuscular stimulation system comprising: a neural signal processor configured to process brain neural signals to generate a processed signal;
E.G. via the disclosed means of electrically stimulating a muscle by monitoring the EMG signal produced by the stimulated muscle and controlling one or more electrical stimulation parameters (Graupe, col 4, lines 24-38).
a neuromuscular cuff including an array of electrodes;
E.G. via the disclosed extremity cuff device for administrating electro-muscular stimulation (EMS 20 having a plurality of EMS electrodes 22 [Hurtado, (col 9, lines 1-6) & (Fig 1)}.
and a pulse stimulator which receives the processed signal and generates a pulse signal that is applied to the array of electrodes of the neuromuscular cuff to produce neuromuscular stimulation of a muscle target.
E.G. via the disclosed voltage/current source 500 that provides an electrical stimulation based an individual adjustment control 32 and then to each electrode 22 [Hurtado, (col 9, lines 59-67) & (Fig4)].
14.
The neuromuscular stimulation system of claim 13, wherein the neural signal processor is configured to: decode the brain neural signals to determine an intended movement; and re-encode the decoded brain neural signals to produce the processed signal comprising pulse trains for corresponding electrodes of the array of electrodes.
E.G. (Graupe, col 4, lines 24-38).
15.
The neuromuscular stimulation system of claim 13, further comprising: a cortical implant that includes a microelectrode sensing array that acquires the brain neural signals.
E.G. (Graupe, col 4, lines 24-38).
16.
The neuromuscular stimulation system of claim 13, wherein the muscle target comprises an arm, a forearm, or a wrist region and the neuromuscular cuff is configured to wrap around the arm, forearm, or wrist.
E.G. via the disclosed extremity cuff which stimulates the muscles in the arms (Hurtado, col 3, lines 53-56).
17.
The neuromuscular stimulation method of claim 13, wherein the processed signal comprises a non-stationary Poisson train with a modulated average pulse rate.
E.G. via the disclosed parameters of the ES signal (Graupe, col 3, lines 30-46).
18.
The neuromuscular stimulation system of claim 13, wherein the pulse signal comprises the processed signal converted into a waveform comprising monophasic and biphasic pulses.
E.G. (Graupe, col 3, lines 30-46).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David 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.
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/NICOLE F JOHNSON/ Primary Examiner, Art Unit 3796