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.
Claim 2 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 2 recites a broad range followed by a narrow range. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “a range of 3mm and 50mm”, and the claim also recites 3mm and 40mm, 3mm and 20mm and 3mm and 5mm which is the narrower statement of the range/limitation. Claim 2 also recites 15mm and 40mm, 15mm and 30mm and 15mm and 25mm. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claim(s) 1-3, 5-7, 13, 19, 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mansfield et al. (US 2020/0138326 A1 – cited by Applicant), hereinafter Mansfield.
Regarding Claim 1, Mansfield teaches: A surface electromyography system for medical use, the system comprising:
a plurality of sensors for detecting muscular electrical activity (figures 2A-2C), each sensor of the plurality of sensors comprising a pair of electrodes and operable to provide an output representing the potential difference between the pair of electrodes (paragraph 0031); and
an output unit coupleable to the plurality of sensors, the output unit operable to provide outputs representing the outputs of each of the plurality of sensors (paragraph 0067).
Regarding Claim 2, Mansfield teaches: The surface electromyography system of claim 1, wherein the electrodes of each pair of electrodes of each of the plurality of sensors are separated by a distance within a range of 3 mm and 50 mm, and optionally wherein the distance is within a range of (i) 3 mm and 40 mm, 3 mm and 20 mm, or 3 mm and 5 mm or (ii) 15 mm and 40 mm, 15 mm and 30 mm, or 15 mm and 25 mm; (paragraph 0084) and/or
wherein at least one of the pairs of electrodes comprises circular electrodes with a diameter between 1 mm and 5 mm (paragraph 0039).
Regarding Claim 3, Mansfield teaches: The surface electromyography system of claim 1, wherein the plurality of sensors are positionable such that at least one sensor of the plurality of sensors is positioned for measuring electrical activity of an external oblique muscle of a subject, and at least one other sensor of the plurality of sensors is simultaneously positioned for measuring electrical activity of an internal oblique muscle of the subject, and wherein the plurality of sensors comprises at least four sensors (figure 2A-2C shows sensor configuration what would be capable of measuring activity from external and internal oblique).
Regarding Claim 5, Mansfield teaches: The surface electromyography system of claim 1, wherein the pairs of electrodes of the sensors are removable; and/or
wherein each sensor of the plurality of sensors comprises one or more recesses adapted to receive at least part of its pair of electrodes (paragraph 0012; figures 2A-2C).
Regarding Claim 6, Mansfield teaches: The surface electromyography system of claim 1, wherein the pairs of electrodes of the sensors comprise electrode pads, the electrode pads being removably mounted in the plurality of sensors; and or/
wherein each sensor comprises a conductive substance for reducing impedance of an electrode to skin contact (figure 2E element 219).
Regarding Claim 7, Mansfield teaches: The surface electromyography system of claim 1, wherein the system is configured to detect a stimulation applied to a subject during use of the surface electromyography system; and
wherein the system is configured to indicate at least one of an amplitude and a timing of the stimulation (paragraph 0137-0138).
Regarding Claim 13, Mansfield teaches: The surface electromyography system of claim 1, wherein each sensor of the plurality of sensors is configured to perform analogue-to-digital conversion of signals detected by its respective electrode pair, and to transmit the digital signals to the output unit; and
wherein each sensor is configured to perform analogue processing of signals detected by its respective electrode pair prior to performing the analogue-to-digital conversion, the analogue processing comprising at least one of: a first amplification, a low pass filtering, a high pass filtering, a second amplification, and an inversion of a common mode voltage (paragraph 0075; 0013; 0105).
Regarding Claim 19, Mansfield teaches: The surface electromyography system of claim 1, wherein the output unit comprises a display for displaying the outputs representing the outputs of each of the plurality of sensors, preferably wherein the output unit provides an output for each of the sensors that is displayed separately and simultaneously on the display (paragraph 0064).
Regarding Claim 22, Mansfield teaches: The surface electromyography system of claim 1, wherein the plurality of sensors are positionable for measuring muscular electrical activity over a region of the surface of a subject's skin (paragraph 0004; 0014; abstract).
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.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansfield in view of Jain et al. (US 2012/0289788 A1), hereinafter Jain.
Regarding Claim 15, Mansfield teaches: The surface electromyography system of claim 1, but does not mention wherein each sensor maintains a respective local clock, wherein the local clocks of the sensors are synchronized.
Jain teaches that a system with multiple sensors can have synchronized local clocks to help with data correlation (paragraph 0095). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system to include wherein each sensor maintains a respective local clock, wherein the local clocks of the sensors are synchronized so that data from each sensor can be aggregated/correlated.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansfield.
Regarding Claim 16, Mansfield teaches: The surface electromyography system of claim 1, wherein the system comprises one or more amplifiers for amplifying the output of the one or more of the plurality of sensors; and
wherein the one or more amplifiers comprises a first amplifier operable to amplify the output of the one or more of the plurality of sensors and a second amplifier operable to amplify the output of the first amplifier (paragraph 0013).
While Mansfield does not explicitly mention the system configured to amplify the output of each of the sensors to a total gain of at least 1000, Examiner notes that it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system to be configured to amplify the output of each of the sensors to a total gain of at least 1000 as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansfield in view of Clements et al. (US 2020/0138313 A1), hereinafter Clements.
Regarding Claim 18, Mansfield teaches: The surface electromyography system of claim 16, but does not mention the system further comprising:
an electrical circuit operable output a signal comprising an inverted common mode voltage of the system; and
a reference electrode operable to feedback the output of the electrical circuit to the plurality of sensors.
Clements teaches an electrical circuit operable output a signal comprising an inverted common mode voltage of the system; and
a reference electrode operable to feedback the output of the electrical circuit to the plurality of sensors (paragraph 0089-0095; figure 10A).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system to include an electrical circuit operable output a signal comprising an inverted common mode voltage of the system; and a reference electrode operable to feedback the output of the electrical circuit to the plurality of sensors in order to have a more accurate true signal.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansfield in view of Manto et al. (US 2008/0033259 A1), hereinafter Manto.
Regarding Claim 20, Mansfield teaches: The surface electromyography system of claim 1, but does not mention wherein the system comprises one or more high pass filters, the one or more high pass filters operable to attenuate the output of at least one of the plurality of sensors below a cut-off frequency between 10 Hz and 20 Hz; and/or
wherein the system comprises one or more low pass filters, the one or more low pass filters operable to attenuate the output of at least one of the plurality of sensors above a cut-off frequency between 400 Hz and 500 Hz; and/or
wherein the system comprises one or more notch filters for removing power line interference; and/or
wherein the system is operable to apply a wavelet filter to the output of the plurality of sensors; and/or
wherein the system is operable to detect a potential difference between each of the pairs of electrodes of less than 1010 μV, less than 5 μV, less than 3 μV or less than 1 μV.
Manto teaches the use if high-pass and/or low-pass filters with EMG sensors (paragraph 0034). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system to include wherein the system comprises one or more high pass filters, the one or more high pass filters operable to attenuate the output of at least one of the plurality of sensors below a cut-off frequency between 10 Hz and 20 Hz; and/or
wherein the system comprises one or more low pass filters, the one or more low pass filters operable to attenuate the output of at least one of the plurality of sensors above a cut-off frequency between 400 Hz and 500 Hz; and/or
wherein the system comprises one or more notch filters for removing power line interference; and/or
wherein the system is operable to apply a wavelet filter to the output of the plurality of sensors; and/or
wherein the system is operable to detect a potential difference between each of the pairs of electrodes of less than 1010 μV, less than 5 μV, less than 3 μV or less than 1 μV for more accurate signal processing.
Regarding the specific cut off frequencies, Examiner notes that it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system to attenuate the output of at least one of the plurality of sensors below a cut-off frequency between 10 Hz and 20 Hz; and/or to attenuate the output of at least one of the plurality of sensors above a cut-off frequency between 400 Hz and 500 Hz; and/or wherein the system operable to detect a potential difference between each of the pairs of electrodes of less than 1010 μV, less than 5 μV, less than 3 μV or less than 1 μV as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Claim(s) 24, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansfield in view of Ko et al. (US 2014/0228650 A1), hereinafter Ko.
Regarding Claim 24, Mansfield teaches: A method of measuring muscular electrical activity over a region of the surface of a subject's skin using the system of claim 1, the method comprising:
detecting a potential difference between the pairs of electrodes (abstract); and
providing an output representative of the potential difference detected by each of the pairs of electrodes (paragraph 0060-0070).
While Mansfield teaches applying the sensor to tissue surface, Mansfield does not explicitly state attaching the plurality of sensors to the subject's skin such that the pairs of electrodes are in contact with the subject's skin.
Ko teaches attaching EMG sensors to the skin of a subject (paragraph 0046). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the method to include attaching the plurality of sensors to the subject's skin such that the pairs of electrodes are in contact with the subject's skin to keep sensors in place while making measurements.
Regarding Claim 25, Mansfield in view of Ko teaches: The method of claim 24, further comprising comparing an amplitude of the potential difference detected by the pairs of electrodes to a threshold amplitude (paragraph 0106).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansfield in view of Ko further in view of Rozin et al. (Electromyography of Anterior Abdominal Muscles During Diffuse and Localized Peritonitis; Arch Surg Vol 106 Feb 1973), hereinafter Rozin.
Regarding Claim 27, Mansfield in view of Ko teach: The method of claim 24, but do not mention further comprising: determining, based on the output representative of the potential difference detected by one or more of the pairs of electrodes, one or more conditions indicative of peritonitis.
Rozin teaches that subjects with peritonitis have an abnormal EMG amplitude (figures 1-6; abstract). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the method to include determining, based on the output representative of the potential difference detected by one or more of the pairs of electrodes, one or more conditions indicative of peritonitis to help diagnose and treat patients with such disorders.
Allowable Subject Matter
Claims 9, 11, 23 and 26 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: No prior art of record teaches the use of EMG along with detection of force applied. None of the prior art considered, alone or in combination, teaches that particular feature combined with the other limitations of the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791