DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-5, 7-12, 14-17, and 38-44 are pending.
Claims 6, 13, and 18-37 are cancelled.
Drawings
The drawings are objected to because the gray-scale figures may not reproduce well. 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 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 1-4, 7, 10, 12, 14-17, and 38-42, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boston et al. (US 20100174342 A1, 2010-07-08) (hereinafter “Boston”)
Regarding claims 1-4, 7, 10, 12, 14-17, and 38-42, Boston teaches a therapeutic electrical muscle stimulation (EMS) apparatus for treatment of a user having a neurological disorder (e.g., [0018]-[0019]), the apparatus comprising: a wearable garment comprising a detection system having one or more sensors configured to detect user-specific biometric movement data and a treatment system comprising a plurality of electrode assemblies (e.g., [0017], [0024]); a processor operably coupled to the one or more sensors, the processor configured to interpret the user-specific biometric movement data to identify a neurological and/or neuromuscular indicator from the user-specific biometric movement data (e.g., Figs. 3-4 and associated text); and wherein the plurality of electrode assemblies are on an inner surface of the wearable garment, further wherein each of the electrode assemblies of the plurality of electrode assemblies are operably connected to the processor, and are configured to supply electrical stimulation to the user, wherein the processor is further configured to apply, from one or more electrodes of the plurality of electrode assemblies, a therapeutic treatment to the user based on the identified neurological and/or neuromuscular indicator (e.g., Fig. 3 and associated text) (as recited in claim 1); wherein the processor comprises a controller configured to initiate EMS via the plurality of electrode assemblies according to an automatically adjustable stimulation regime based on the data (e.g., Fig. 4 and associated text) (as recited in claim 2); wherein the one or more sensors comprise at least one accelerometer configured to detect a change in acceleration associated with the neurological disorder (e.g., [0089]-[0104]) (as recited in claim 3); further comprising an interface configured to communicate with one or more remote databases to acquire predetermined user-specific biometric data, wherein the therapeutically effective amount of electrical stimulation is adjusted by the predetermined user-specific biometric data (e.g., [0090]-[0092], [0122]-[0126]) (as recited in claim 4); wherein a stimulation regime defines a duration, intensity, location, pulse pattern, or stimulation sequence, and wherein the stimulation regime is configured to be automatically adjusted based on subsequent user-specific biometric data (e.g., [0090]-[0092], [0122]-[0126]) (as recited in claim 7); wherein the user-specific biometric data is associated with an incidence of a tremor (e.g., [0081) (as recited in claim 10); wherein the therapeutically effective amount of electrical stimulation is automatically adjusted based on subsequent user-specific biometric data (e.g., [0090]-[0092], [0122]-[0126]) (as recited in claim 12); wherein at least one of the one or more sensors comprises an electromyography sensor and the processor is configured to predict a tremor based on data from the one or more sensors comprising the electromyography sensor (e.g., [0087]) (as recited in claim 14); wherein the processor is configured to apply EMS prior to an involuntary muscle contraction associated with a tremor (e.g., [0112]-[0125]) (as recited in claim 15); wherein the neurological disorder is selected from a group consisting of: Alzheimer's disease, Parkinson's Disease, Huntington's Disease, brain injury, spinal cord injury, autoimmune disease, restless leg syndrome, essential tremor, and a genetic neurological disease (e.g., [0086]) (as recited in claim 16); wherein the therapeutically effective amount of electrical stimulation is sufficient to prevent or reduce involuntary muscle activity associated with the neurological disorder (e.g., [0090]-[0092], [0122]-[0126]) (as recited in claim 17); a method of treating a user for a neuromuscular disorder, the method comprising: receiving user movement data from one or sensors of an electrical muscle stimulation (EMS) suit worn by the user; detecting a neurological and/or neuromuscular indicator from the user movement data (e.g., Figs. 3-5 and associated text); applying, from one or more electrodes of the EMS suit a therapeutic treatment to the user within 1 minute of detecting the neurological and/or neuromuscular indicator (e.g., [0090]-[0092], [0122]-[0126]) (as recited in claim 38); wherein receiving comprises receiving accelerometer data (e.g., [0089]-[0104]) (as recited in claim 39); wherein receiving comprises receiving movement data having a frequency consistent with tremor in one or more body parts (e.g., [0017]-[0018]) (as recited in claim 40); wherein the frequency is greater than 2 Hz (e.g., [0105]) (as recited in claim 41); wherein the neurological and/or neuromuscular indicator is consistent with stroke (e.g., [0086]) (as recited in claim 42).
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.
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 5, 8, 9, 11, 43, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Boston.
Regarding claims 5, 8, 9, 11, 43, and 44, as discussed above, Boston teaches a therapeutic electrical muscle stimulation (EMS) apparatus for treatment of a user having a neurological disorder, except comprising the limitations recited in the claims at issue.
However, Boston teaches that the “[t]he methods and systems of the invention can be adapted to a variety of body sites, and can be adapted to use a variety of sensing parameters both individually and in combination. The methods and systems can be adapted to work with more than one pair of antagonistic muscles.” See [0126]. Boston also teaches use of peak FFT detection. See, e.g., [0091].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention taught by Boston such that the invention further comprises wherein the processor is configured to establish one or more thresholds based on initial user-specific biometric data, wherein the initial user-specific biometric data is acquired by the one or more sensors for a predetermined duration beginning with a first use of the EMS (e.g., [0091]) (as recited in claim 5); wherein the wearable garment comprises an upper torso region (e.g., [0126) (as recited in claim 8); wherein the wearable garment comprises a lower region that is configured to confirm the user's legs and buttocks (e.g., [0126]) (as recited in claim 9); wherein the therapeutically effective amount of electrical stimulation is associated with an adjustable threshold (e.g., [0091]) (as recited in claim 11); wherein the neurological and/or neuromuscular indicator is consistent with Alzheimer's disease (e.g., [0086], [0126]) (as recited in claim 43); further comprising identifying and outputting a potential pathology associated with the neurological and/or neuromuscular indicator (e.g., [0126]) (as recited in claim 44) in order to enhance the applicability of the invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Jackson, can be reached on 571-272-4697. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Scott Luan
/SCOTT LUAN/Primary Examiner, Art Unit 3792
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