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 § 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.
Claims ???? 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.
Regarding Claim 1, Applicant claims “an electrode…having a plurality of electrode pads”. It is unclear how a singular structure (an electrode) can be comprised of multiple structures/electrodes (a plurality of electrode pads). The Examiner suggests amending the claim to read “a plurality of electrodes” rather than “an electrode”.
In regard to Claim 11, Applicant uses the term “aimed at turning the device to an active mode”. As written, this is a passive limitation that does not actually require the activation of an active mode but merely an intent or desire to do that at some point. It is unclear if Applicant is intending to actively claim the selection of an active mode or not. The metes and bunds are unclear. If Applicant intends the selection of an active mode, the Examiner suggests amending the claim to eliminate the term “aim” and instead claim “turning the device to an active mode” or some variant thereof.
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 1-12 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Giuffrida (US Patent 10,022,545).
Regarding Claims 1, 7 and 8, Giuffrida discloses a functional electrical stimulation (FES) system comprising an electrode 68 configured to be disposed on an upper limb (arm) of a user, the electrode having a plurality of electrode pads (see Fig. 4; col. 8, line 66); and a stimulator 64 having an embedded sensor 50 configured to continuously measure movement of the stimulator and to emit sensor measurements indicative thereof (Fig. 4; col. 8, lines 15-20). Giuffrida further discloses a control means (microprocessor in stimulator 64, not shown, see col. 8, lines 34-35) communicatively coupled to the stimulator 64 and embedded sensor 50 and configured to process the sensor measurements and determine an intention of the user to perform an action with the upper limb. Lastly, Giuffrida discloses controlling stimulation applied via the electrode pads based on the sensor measurements (col. 14, line 51-col. 15, line 13; col. 16, lines 40-61) .
In regard to claim 2, the Examiner notes the limitation “wherein the movement…is a sharp movement of the stimulator preceded by a first rets period and followed by a second rets period” is an intended use limitation. 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, Giuffrida is capable of detecting a sharp movement after a period of no movement/ rest (the initial attempting of a task from rest) that occurs before another period of rest (the task is complete and the subject is at rest again)
In regard to claim 2, the Examiner notes the limitations regarding the types of movement that are detected are intended use limitations. 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. Giuffrida discloses the sensors can detect impaired movement, such as that cause by a stroke (col. 17, lines 23-37).
Regarding Claims 4 and 5, Giuffrida discloses a combination of accelerometers, gyroscopes and magnetometers (known components of inertial measurement units) to measure three-dimensional; movement (movement along three axes), see col. 6, line 62-col. 7, line 2; col. 8, lines 15-20.
In regard to Claim 6, Giuffrida discloses using EMG sensors as well (col. 4, lines 52-63; col. 8, lines 27-30).
In regard to Claim 9, Giuffrida discloses the system is designed to sense impaired arm movement and aid in the arm movement with stimulation (col. 4, lines 39-51).
Regarding Claim 10, the Examiner notes the claimed movement pattern would occur during the normal operation of the device of Giuffrida. A person would be at rest awaiting instructions on a video; the patient would move from rest (a sharp motion) to perform the task from the video; and then the person would resume a rest state after the task is completed.
In regard to Claim 11, to the Examiner’s best understanding of the claimed invention in light of the indefiniteness of the claim, Applicant appears to be claiming a period of time in which electrodes are not activated. This would occur during normal use of the device. When the therapy session is over, there would be a period of time in which the device does not apply therapy. It could occur when the device is removed and would last until the next therapy session.
Regarding Claim 12, Giuffrida discloses the algorithm learns from measured data over time (col. 17, line 56-col. 18, line 3). So each iteration of a therapy session uses data from before a therapy task is detected (a patient is at rest, see steps 200 202 before step 204 in Fig. 6). The next iteration in which the initial data is collected occurs after an end rest period of the previous session.
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 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Giuffrida (US Patent 10,022,545) in view of Meyers et al. (2023/0065510).
In regard to Claim 13, Giuffrida discloses identifying an intent to move but does not provide details indicating detecting movement when measurements from the sensor are above twice a baseline value. In the same field of endeavor of FES control for movement assistance, Meyer discloses identifying specific movement intentions by comparing EMG action potentials to various baselines (par. [0071-0073]) such that therapy can be more accurately provided to the specific muscle groups involved in the intended action. 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 Giuffrida reference to include comparing EMG data to baseline values, as taught and suggested by Meyers, for the purpose of accurately identifying movement intentions that can more accurately control stimulation to the muscles involved in the intended movement. Giuffrida and Meyer do not specifically disclose any particular amplitude values as those would be patient and movement specific. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a value twice a baseline value (such as a spike in activity as disclosed in Fig. 5 of Meyers), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In regard to Claim 14, Giuffrida disclose utilizing gyroscopes to identify movement intent but fails to disclose any particular measures of degrees per second that would identify a movement. Giuffrida does disclose that the level of movement of a user will change over time as therapy improves the patient’s motor function. The Examiner notes the particular measure of degrees per second is highly dependent on a user’s movement ability. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a baseline value of between 0-12 dps (indicative of a baseline rets state) and a value over 15 dps (that would be twice the amount of the first value) to indicate a particular movement over a baseline state, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding Claim 15 and the rest period length and movement period length, the Examiner notes these time frames with respect to Giuffrida are a result of time between tasks as prompted by a video screen and are result effective variables set by a user or clinician. While Giuffrida does not disclose any particular lengths of time of therapy session or times between tasks or between periods of movement/non-movement, the Examiner notes it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a first rest period between 100-250ms; a movement period between 250-1000, and a second rets period between 150 and 750 ms, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLEN PORTER whose telephone number is (571)270-5419. The examiner can normally be reached Mon - Fri 9:00-6:00 EST.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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