DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 3-8 are 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 3, the limitation “the determined abnormal installation cause” lacks proper antecedent basis, as Claim 1 instead recites “determine which of a plurality of abnormal installation causes…”.
Regarding Claims 3-7, the limitation “the abnormal installation cause” lacks proper antecedent basis, as Claim 1 instead recites “a plurality of abnormal installation causes”. For purposes of examination the indefinite limitation has been deemed to claim where an abnormal installation cause is determined from the plurality of abnormal installation cases.
Regarding Claims 4 and 6, the limitation “the stimulation electrode” lacks proper antecedent basis, as Claim 1 instead recites “at least one stimulation electrode”.
Regarding Claims 5 and 7, the limitation “the stimulation output unit” lacks proper antecedent basis, as the limitation is previously claimed.
Regarding Claims 5 and 6, the limitation “or” in the context of the claimed invention renders the claim indefinite. It is unclear if the claim language after “or” is intended to be part of the claimed invention. As currently written, those statements are in the alternative (e.g., one or the other). But at set forth in Claim 1, it appears Claims 5 and 6 may be the plurality of abnormal causes, and Applicant is actually attempting to claim that the process is capable of determining between those two conditions.
Regarding Claims 6 and 7, the limitation “the lead-out electrode” lacks proper antecedent basis, as Claim 1 instead recites “a plurality of lead-out electrodes”.
The term “too-close” in claim 6 is a relative term which renders the claim indefinite. The term “too-close” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding Claim 8, the limitations “a stimulation procedure of stimulating a nerve via a stimulation electrode attached to a living body” and “causing stimulation of the nerve” render the claim indefinite as it duplicates the stimulation step. Therefore it is unclear if there is more than one stimulation. For purposes of examination the indefinite limitation has been deemed to claim one stimulation.
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190008453 A1 to Spoof.
Regarding Claim 8, Spoof discloses a non-transitory computer readable storage medium storing a muscle relaxation monitoring program comprising instructions which, when executed by a computer, cause the computer to perform (microcontroller 123) inter alia:
a stimulation procedure of stimulating a nerve via a stimulation electrode attached to a living body ([0011] “a neuromuscular transmission (NMT) monitoring system configured to monitor an amount of neuromuscular blockage after the administration of muscle relaxants in patients during surgery”) ([0016] “neurostimulators 115a and 115b are connected to stimulating electrodes 120a and 120b, respectively, which may apply an electrical stimulus to the patient's ulnar nerve at a pre-determined time interval”),
a detection procedure of detecting an electromyogram signal received via a plurality of lead-out electrodes attached to the living body, the electromyogram signal being a physiological signal generated from a muscle in response to the stimulation, and a determination procedure of causing the stimulation of the nerve and determining an abnormal installation cause, based on the detected electromyogram a waveform of the detected electromyogram signal ([0030] “Further still, the microcontroller may be configured to detect errors in the signal received from any of the sensing electrodes (e.g., sensing electrodes 120c-120e for EMG sensor … microcontroller may detect errors such as out-of-range values (e.g., negative values) and alert the user that the electrodes may not be placed properly (e.g., if the electrodes become loose or detached from the skin).”) (Spoof continuously analyzes the detected EMG and threshold-on-amplitude which is waveform based, see [0026], [0030], and [0053], because under broadest reasonable interpretation the amplitude/magnitude of a signal is a property of a waveform, the waveform being indicative if the electrodes are improperly attached/detached).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190008453 A1 to Spoof in view of US 20150038873 A1 to Boettcher et al. (hereinafter, Boettcher), and further in view of US 20090012381 A1 to Kuramori et al. (hereinafter, Kuramori).
Regarding Claims 1 and 8, Spoof discloses a muscle relaxation monitoring device ([0011] “a neuromuscular transmission (NMT) monitoring system configured to monitor an amount of neuromuscular blockage after the administration of muscle relaxants in patients during surgery”) comprising inter alia:
a controller (microcontroller 123) configured to:
cause a stimulation of a nerve via at least one stimulation electrode attached to a living body of a subject ([0016] “neurostimulators 115a and 115b are connected to stimulating electrodes 120a and 120b, respectively, which may apply an electrical stimulus to the patient's ulnar nerve at a pre-determined time interval”);
detect an EMG signal via a plurality of lead-out electrodes attached to the living body, the EMG signal being a physiological signal generated from a muscle in response to the stimulation and determine a first abnormal installation cause present based on a waveform of the detected EMG signal ([0030] “Further still, the microcontroller may be configured to detect errors in the signal received from any of the sensing electrodes (e.g., sensing electrodes 120c-120e for EMG sensor … microcontroller may detect errors such as out-of-range values (e.g., negative values) and alert the user that the electrodes may not be placed properly (e.g., if the electrodes become loose or detached from the skin).”) (Spoof continuously analyzes the detected EMG and threshold-on-amplitude which is waveform based, see [0026], [0030], and [0053], because under broadest reasonable interpretation the amplitude/magnitude of a signal is a property of a waveform, the waveform being indicative if the electrodes are improperly attached/detached). Spoof discloses the claimed invention except for expressly disclosing where a plurality (e.g., a second) of abnormal installation causes are determined based on a waveform.
Boettcher teaches a device for “stimulating living tissue of human subjects, and more particularly to stimulating peripheral nerves in order to determine nerve conduction properties” [0010]. Boettcher also teaches detecting an EMG signal via a plurality of lead-out electrodes attached to the living body, the EMG signal being a physiological signal generated from a muscle in response to the stimulation and determine a second abnormal installation cause present based on a waveform of the detected EMG signal (detection of short or shunt between two stimulator probes by monitoring magnitude of stimulus artifact waveform and voltage difference between anode and cathode probe [0020]-[0022], stimulus artifact size which is thousands of microvolts when no alternative conduction path exists and smaller when it exists [0075] and finally using decaying rates to detect the existence of an alternative conductive path [0077] and stop never conduction testing to check for source of shorting [0078]).
Spoof in view of Boettcher teach the claimed invention except for expressly disclose determining which of the first and second (e.g., the plurality) abnormal installation causes is present – even in combination, the controller still wouldn’t be configured to make the determination between which erroneous condition has occurred.
However, Kuramori teaches acquiring EMG information from the human body and determining which electrodes are inappropriately attached [0002]. Kuramori is able to not only determine which electrodes an inappropriate, but also distinguish between at least two inappropriate conditions, including between a peel-off and a short-circuit between electrodes [0055]. Kuramori teaches when an inappropriate condition is determined, the measurement operation is a failure and a warning is generated [0006].
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to combine Spoof in view of Boettcher, because Spoof teaches that their EMG waveform detection would have ensured that an appropriate block is provided for a medical procedure [0002], and similarly, Boettcher teaches that their EMG waveform detection makes sure there is proper nerve stimulation (e.g., both ensure a medical procedure is accurate).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the combination of Spoof in view of Boettche with Kuramori, as Kuramori teaches it is important to also known which of a plurality of electrodes are inappropriately attached [0002] and furthermore, is able to determine which of two inappropriate conditions are occurring, and where they are occurring [0055] (e.g., judging whether or not peeling of an electrode or a short-circuit is occurring). Kuramori expressly recites that this combination would have allowed a skilled artisan to reduce time to recover from inappropriate attachment of the electrodes to resume measurement [0023].
Regarding Claim 2, Spoof in view of Boettche and further in view of Kuramori teach a notification output unit configured to notify of the abnormal installation cause (Spoof: [0018], Boettche: [0063], [0078], Kuramori: [0066]).
Regarding Claim 3, Spoof in view of Boettche and further in view of Kuramori teach a notification output unit configured to notify a response content corresponding to the determined abnormal installation (Spoof: notifying the user to check on the EMG [0053], Boettche: message for checking potential source of shorting [0078], Kuramori: readily bring the electrode to a normal attachment site [0023]).
Regarding Claim 4, Spoof in view of Boettche and further in view of Kuramori teach where the controller is further configured to set a current value of stimulation current for the stimulation of the nerve via the stimulation electrode, and the controller determines the abnormal installation cause at a time when the controller sets the current value of the stimulation current (Boettche: stimulation current of 20mA is used to detect the presence of an alternative conductive path [0075] and sequentially increasing the stimulus intensity from 20mA to 60mA in 10 mA steps [0079] e.g., at the moment the device is dialing in the stimulation current, it uses the current setting of 20mA to check for electrode fault, setting the current and finding the fault happen in the same step).\
Allowable Subject Matter
Claims 5-7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791
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