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 1-15 and 18 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.
Claim 1 and 8-10 recite the term “low current”. It is unclear what qualifies as a “low” current and what does not. The term “low current” 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. For the purposes of substantive examination, any reference that recites a generating a low current or low voltage stimulus will be construed to read on all instances of “low current” in the claims.
Claims 2-15 are rejected by virtue of dependence on Claim 1.
The examiner notes Claim 16 is not rejected under 35 U.S.C. § 112(b) although it recites the same term, as “low current electrical impulses” are clearly defined as between 0.2 and 4 mA.
Claim 4 recites “wherein the nerve stimulation device is configured to transmit electrical impulses in the range of about 0.5 millivolts to 1.5 millivolts to patients having a body mass index in a first range; and wherein the nerve stimulation device is configured to transmit electrical impulses in the range of about 1.5 millivolts to 4 millivolts to patients having a body mass index in a second range that is higher than the first range”. The term “about” is a relative term which renders the claim indefinite. The term “about” 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. For the purposes of substantive examination, the examiner is construing this claim limitation as “wherein the nerve stimulation device is configured to transmit electrical impulses in the range of ”.
Claim 18 recites “wherein a determination is made that a second dose of the paralysis agent should be administered if the response signal is substantially similar to the baseline muscle response”. The term “substantially” is a relative term which renders the claim indefinite. The term “substantially” 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. For the purposes of substantive examination, the examiner is construing the term “the response signal is substantially similar to the baseline muscle response” as the response signal being ± 50% of the baseline muscle response.
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.
Claims 1-2, 6, 8-9, and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Brull et al (US 20130204155 A1) in view of Gharib et al (US 20090177112 A1).
Regarding Claim 1, Brull discloses a paralysis monitoring system (See Fig. 1) comprising:
a nerve stimulation device (Element 108) configured to deliver a series of electrical impulses to a nerve (“The nerve stimulator 108 is capable of delivering electrical pulses to a motor nerve such as the median or ulnar nerve at the wrist, the tibial nerve at the ankle or the facial nerve beneath the ear, for example”, [0076]; See Fig. 1); and
a recording device (Elements 104 and 106 paired with elements 110 and 112, respectively; see Fig. 1) configured to record electrical activity associated with an evoked muscle response caused by the series of electrical impulses (“The electrical pulse delivered by the nerve stimulator 108 should be sufficient in strength to elicit nerve responses when the patient is in an unblocked state”, [0076]; “”, [0081]; See Fig. 1).
Brull discloses the claimed invention except for expressly disclosing the series of electrical impulses to a nerve being a series of low current electrical impulses to a nerve to produce only sub-visible muscle responses;
wherein the low current electrical impulses that the nerve stimulation device is configured to deliver are between 0.2 mA – 4 mA.
However, Gharib, which also discloses a nerve stimulation device (Element 21, Fig. 1) configured to deliver a series of electrical impulses to a nerve (“Stimulation signals generated may include a train of pulses (N) ranging in number from 1 to 8”, [0074]), teaches the series of electrical impulses to a nerve being a series of low current electrical impulses to a nerve to produce only sub-visible muscle responses (“the hardware employed by the control unit to provide a stimulation signal may comprise a patient module capable of delivering a range of low voltage pulses at a constant current (or constant voltage, if desired) for stimulating a nerve”, [0019]; see the rejection of this claim under 35 U.S.C. § 112(b) above; the examiner notes the applicant’s specification defines electrical impulses that produce sub-visible responses to be between 0.1 and 4 millivolts, which is taught by Gharib in [0074]);
wherein the low current electrical impulses that the nerve stimulation device is configured to deliver are between 0.2 mA – 4 mA (“MEP stimulator 21 is current controlled and may deliver stimulation pulses with a current level (I) ranging from 0 mA to 1000 mA”, [0074]; see Claim 5; this range overlaps and therefore anticipates the claimed range of 0.2-4 mA).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the low current electrical impulses of Gharib that only produce a sub-visible muscle response, wherein the low current electrical impulses that the nerve stimulation device is configured to deliver are between 0.2 mA – 4 mA, because Gharib discloses a reasonable expectation of success when determining nerve pathology from low voltage stimulation (see [0019] and [0074] of Gharib).
Regarding Claim 2, modified Brull discloses the paralysis monitoring system according to claim 1, wherein the paralysis monitoring system is configured to administer a calibration signal with the nerve stimulation device and record a baseline muscle response with the recording device (“Another example method for assessing neuromuscular blockade in a subject having been administered a muscle relaxant agent includes stimulating a motor nerve to cause a first and a subsequent evoked muscle responses and recording the first and subsequent evoked muscle responses. A peak of the first and subsequent recorded evoked muscle responses are identified and a subsequent peak of the first and subsequent recorded evoked muscle responses are identified.”, [0036]; also see [0021], [0026]); and
wherein the paralysis monitoring system is configured to compare subsequent recorded muscle responses to the baseline muscle response (“The peak-to-peak amplitude of the first recorded evoked muscle response and the peak-to-peak amplitude of the subsequent recorded evoked muscle response are determined. The peak-to-peak amplitudes are compared…”, [0036]).
Regarding Claim 6, modified Brull discloses the paralysis monitoring system according to claim 1, wherein the recording device comprises an electrode (“ sensing electrodes 104 and 106 ”, [0078]) or a needle.
Regarding Claim 8, modified Brull discloses the paralysis monitoring system according to claim 1, wherein the nerve stimulation device is configured to provide the low current electrical impulses on an automatic cycling schedule (“The neuromuscular function is directly assessed by comparing the evoked muscle response (the evoked electrical activity behind the muscle "twitch") in response to electrical stimulation of the corresponding motor nerve. Adequate muscle relaxation has been achieved when the muscle response to repetitive stimulation is extinguished while nerve conduction remains intact. The device repeats the assessment when manually or automatically triggered (at user-selected intervals), providing ongoing monitoring of neuromuscular function status throughout any procedure, using any peripheral motor nerve.”, [0072]).
Regarding Claim 9, modified Brull discloses the paralysis monitoring system according to claim 8, wherein the automatic cycling schedule transmits the low current electrical impulses on an incremental basis (“An example system for determining a train-of-four ratio includes a stimulator configured to produce stimuli for provision to a motor nerve a first, second, third and fourth time and a recording apparatus configured to record muscle electrical activity in a muscle innervated by the stimulated motor nerve subsequent to each stimulation of the motor nerve…Optionally, each stimulus is temporally distinct”, [0050]).
Regarding Claim 11, modified Brull discloses the paralysis monitoring system according to claim 1, wherein the paralysis monitoring system is configured to apply an intermittent pulse that is repeated periodically (“The neuromuscular function is directly assessed by comparing the evoked muscle response (the evoked electrical activity behind the muscle "twitch") in response to electrical stimulation of the corresponding motor nerve. Adequate muscle relaxation has been achieved when the muscle response to repetitive stimulation is extinguished while nerve conduction remains intact. The device repeats the assessment when manually or automatically triggered (at user-selected intervals), providing ongoing monitoring of neuromuscular function status throughout any procedure, using any peripheral motor nerve.”, [0072]); and wherein the paralysis monitoring system is further configured to measure and record a response to the intermittent pulse to determine an effect of a paralytic agent (“Provided are systems, devices and methods for monitoring anesthesia. For example, the methods, devices and systems are optionally used to assess neuromuscular blockade in a subject who has received a muscle relaxant (NMBA) agent”, Abstract).
Regarding Claim 12, modified Brull discloses the paralysis monitoring system according to claim 1, wherein the recording device is configured to record a spike focus of the evoked muscle response (“Another example method for assessing neuromuscular blockade in a subject having been administered a muscle relaxant agent includes stimulating a motor nerve to cause an evoked muscle response. The evoked muscle response is recorded. A peak of the recorded evoked muscle response is identified.”, [0021]).
Regarding Claim 13, modified Brull discloses the paralysis monitoring system according to claim 1, further comprising an alarm (“a visual display”, [0080]; “audible tones may optionally be used for alarms”, [0080]) configured to provide an alert upon detecting a return of response signals or muscle activity of a patient (“The display may utilize different colors to indicate different levels of neuromuscular block. For example, the color green may be used to represent a TOF ratio between 1.0 and 0.90, the color yellow may be used to represent a TOF ratio between 0.89 and 0.40 and the color red may be used to represent a TOF ratio between 0.39 and 0.01”, [0107]).
Regarding Claim 14, modified Brull discloses the paralysis monitoring system according to claim 1, further comprising a signal processor (Element 120, Fig. 1) in communication with the recording device (“The control/visualization unit 132 may contain user-input controls and a visual display, store operating protocols, collect patient data and generate a system clock”, [0080]).
Regarding Claim 15, modified Brull discloses the paralysis monitoring system according to claim 14, wherein the signal processor is connected to a display (“The control/visualization unit 132 may contain user-input controls and a visual display, store operating protocols, collect patient data and generate a system clock”, [0080]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Brull in view of Gharib, and further in view of Bikson et al (US 20130184779 A1).
Regarding Claim 3, modified Brull discloses the paralysis monitoring system according to claim 1. Modified Brull discloses the claimed invention except for expressly disclosing wherein the nerve stimulation device is configured to transmit electrical impulses to a patient based on a body mass index of the patient. However, Bikson, which is also directed towards a nerve stimulation device (Element 100, Fig. 1), teaches wherein the nerve stimulation device is configured to transmit electrical impulses to a patient based on a body mass index of the patient (“The appropriate voltage limit can be adjusted based on one or a combination of factors including … subject body mass index”, [0090]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brull in view of Gharib such that the nerve stimulation device is configured to transmit electrical impulses to a patient based on a body mass index of the patient as taught by Bikson because this allows the electrical impulses to be adjusted to suit each patient during a procedure (See [0095] of Bikson).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Brull in view of Gharib and Bikson, and further in view of Gollan (US 20180345003 A1).
Regarding Claim 4, modified Brull discloses the paralysis monitoring system according to claim 3. Modified Brull discloses transmitting electrical impluses based on a body mass index of a patient, but fails to expressly disclosing wherein the nerve stimulation device is configured to transmit electrical impulses in the range of about 0.5 millivolts to 1.5 millivolts to patients having a body mass index in a first range; and
wherein the nerve stimulation device is configured to transmit electrical impulses in the range of about 1.5 millivolts to 4 millivolts to patients having a body mass index in a second range that is higher than the first range.
However, Gollan teaches wherein a nerve stimulation device (Element 30, Figs. 1-2) is configured to transmit electrical impulses to patients having a body mass index in a first range (“In one embodiment, having BMI of 15-20 would require stimulation intensity of 1 mA-20 mA, pulse width of 50 μs-200 μs, frequency of 1 Hz-100 Hz”, [0113]); and
wherein the nerve stimulation device is configured to transmit electrical impulses to patients having a body mass index in a second range that is higher than the first range (“In other embodiment, BMI of 18-25 would require stimulation intensity of 15 mA-30 mA, pulse width of 150 μs-500 μs, frequency of 80 Hz-250 Hz. Yet in another embodiment, BMI of 22-30 would require stimulation intensity of 12 mA-50 mA, pulse width of 400 μs-1000 μs, frequency of 200 Hz-1 kHz”, [0113]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brull with Gollan because the thicker the fat layer between the skin and muscles/nerves (which correlates to higher BMI, see [0113] of Gollan), the more stimulation intensity is required for effective stimulation (See [0113] of Gollan). Furthermore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to transmit electrical impulses in the range of about 0.5 millivolts to 1.5 millivolts for patients having a body mass index in a first range and transmit electrical impulses in the range of about 1.5 millivolts to 4 millivolts to patients having a body mass index in a second range that is higher than the first range, since it has been held that where the general conditions of a claim are disclosed in the prior art (see Gharib which discloses the claimed ranges), it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05.II. In addition, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2144.05.II.B.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Brull in view of Gharib, and further in view of Hoskonen et al (US 20050085741).
Regarding Claim 5, modified Brull discloses the paralysis monitoring system according to claim 1. Modified Brull discloses the claimed invention except for expressly disclosing wherein the nerve stimulation device and the recording device are disposed on a strip. However, Hoskonen, which is also directed towards a paralysis monitoring system (See Abstract) teaches wherein the nerve stimulation device (Elements 1-2, Fig. 1) and the recording device (Element 6, Fig. 1) are disposed on a strip (Element 9, Fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brull with the teachings of Hoskonen, because this allows the paralysis monitoring system to be designed freely according to the existing need of the patient, as taught by Hoskonen ([0029]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Brull in view of Gharib, and further in view of Barsa (US 4570640 A).
Regarding Claim 7, modified Brull discloses the paralysis monitoring system according to claim 1. Modified Brull discloses the claimed invention except for expressly disclosing wherein the nerve stimulation device comprises a transcutaneous electrode probe configured to transmit milliamp current. However, Barsa, which is also directed towards a paralysis monitoring system (See Abstract), teaches wherein the nerve stimulation device comprises a transcutaneous electrode probe (See Figs. 1-2; “A unit of transcutaneous nerve stimulation was used as a source of variable electric stimuli”, 20:16-17) configured to transmit milliamp current (See Figs. 17-18; see page 18, lines 21-34). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brull with the transcutaneous electrode probe configured to transmit milliamp current of Barsa, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Brull in view of Gharib, and further in view of Hulvershorn et al (US 20190223764 A1).
Regarding Claim 10, modified Brull discloses the paralysis monitoring system according to claim 9. Modified Brull discloses the claimed invention except for expressly disclosing wherein the low current electrical impulses are increased until a predetermined muscle response is received by the recording device. However, Hulvershorn, which is also directed towards a paralysis monitoring system ([0058]), teaches wherein the electrical impulses are increased until a predetermined muscle response is received by the recording device (“The monitor 101 can include a calibration routine that gradually raises the stimulation current applied to the patient through the lead assembly 105 until further increases in current do not result in a larger muscle twitch”, [0070]). It would have been obvious to modify the already low current electrical impulses of Brull with the increasing step of Hulvershorn, because this is an additional method of calibration (See Hulvershorn, [0022]) with a reasonable expectation of success (see [0070] of Hulvershorn).
Claims 16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brull in view of Gharib, and further in view of Jansen et al (US 20040068229 A1).
Regarding Claim 16, Brull discloses a method of monitoring patient paralysis, the method comprising:
attaching a nerve stimulation device to a patient’s anatomy (Step 202, Fig. 2);
attaching a first recording device to the patient’s anatomy (“Place electrodes on muscle”, Step 204, Fig. 2);
transmitting electrical impulses from the nerve stimulation device to the patient (Step 206, “Start Stimulation”, Fig. 2), and wherein the patient has received a first dose of paralysis agent (Step 204 “Apply neuromuscular block”, Fig. 2);
receiving a response signal corresponding to muscle activity of the patient in the first recording device (Step 206 recursive “interpret results of current stimulus”, Fig. 2); and
using information related to the response signal to determine needed changes to the applied paralysis agent (Step 206, Fig. 2; “change medication if necessary”).
Brull discloses the claimed invention except for expressly disclosing the method comprising:
transmitting low current electrical impulses from the nerve stimulation device to the patient, wherein the low current electrical impulses are between 0.2 mA – 4 mA; and
using information related to the response signal to determine an amount of the paralysis agent to administer as a second dose.
However, Gharib, which also discloses a method of monitoring patient paralysis (See Abstract), teaches transmitting low current electrical impulses from the nerve stimulation device to the patient (“the hardware employed by the control unit to provide a stimulation signal may comprise a patient module capable of delivering a range of low voltage pulses at a constant current (or constant voltage, if desired) for stimulating a nerve”, [0019]), wherein the low current electrical impulses are between 0.2 mA – 4 mA (“MEP stimulator 21 is current controlled and may deliver stimulation pulses with a current level (I) ranging from 0 mA to 1000 mA”, [0074]; see Claim 5; this range overlaps and therefore anticipates the claimed range of 0.2-4 mA). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the low current electrical impulses of Gharib, wherein the low current electrical impulses are between 0.2 mA – 4 mA, because Gharib discloses a reasonable expectation of success when determining nerve pathology from low voltage stimulation (see [0019] and [0074] of Gharib).
Jansen, which is also directed towards a method of monitoring patient paralysis (See Abstract) teaches using information related to the response signal (“The effect of the muscle relaxant on the patient, i.e. the so-called relaxation, is assessed either by clinical observations alone; subjectively quantified by use of a peripheral nerve stimulator (PNS); or it can be measured objectively by means of a neuromuscular transmission monitor”, [0007]) to determine an amount of the paralysis agent (“ The controller 101 uses the received measurements to control the amount of muscle relaxant to be delivered to the patient”, [0054]; “Based upon the actual level of relaxation and the specific selected control values, the controller 101 determines the amount of relaxant to be used in the further dosing in order to reach the target state”, [0055]) to administer as a second dose (“When the effect of the muscle relaxant begins to disappear or decrease, meaning that the patient is becoming less relaxed, additional doses of muscle relaxant may be administered to the patient to ensure sufficient surgical relaxation and hereby enable the procedure to continue”, [0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Brull with the method step of Jansen because this allows the minimum amount of drug needed to obtain the desired effect to be used, which allows for the fastest possible patient recovery (See Jansen, [0017]).
Regarding Claim 18, modified Brull discloses the method according to claim 17. Modified Brull discloses the claimed invention except for expressly disclosing wherein a determination is made that a second dose of the paralysis agent should be administered if the response signal is substantially similar to the baseline muscle response. However, at the time of the invention, there was a recognized need for optimizing the relationship between the response signal and the determination for the second dose (and amount thereof) (See Jansen, [0055], [0068], [0075]-[0079]; see Figs. 3A-4). One of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. 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 method of Brull, with the obvious to try of determining is made that a second dose of the paralysis agent should be administered if the response signal is substantially similar to the baseline muscle response.
Regarding Claim 19, modified Brull discloses the method according to claim 16. Modified Brull discloses the claimed invention except for expressly disclosing wherein the low current electrical impulses have magnitudes to produce only sub-visible muscle responses. However, Gharib teaches wherein the low current electrical impulses have magnitudes to produce only sub-visible muscle responses (“the hardware employed by the control unit to provide a stimulation signal may comprise a patient module capable of delivering a range of low voltage pulses at a constant current (or constant voltage, if desired) for stimulating a nerve”, [0019]; see the rejection of this claim under 35 U.S.C. § 112(b) above; the examiner notes the applicant’s specification defines electrical impulses that produce sub-visible responses to be between 0.1 and 4 millivolts, which is taught by Gharib in [0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Brull to produce a sub-visible muscle response, because Gharib discloses a reasonable expectation of success when determining nerve pathology from low voltage stimulation (see [0019] and [0074] of Gharib).
Regarding Claim 20, modified Brull discloses the method according to claim 16, the method further comprising attaching a second recording device to the patient’s anatomy (“Place electrodes on muscle”, Step 204, Fig. 2; see Fig. 1, where multiple recording electrodes are used), wherein the second recording device is located away from the first recording device (“In one implementation, differential recording leads may be placed over active sites, i.e., one lead over the muscle and the other lead over the nerve to collect both responses in a single recording channel”, [0088]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Brull in view of Gharib and Jansen, and further in view of Hulvershorn.
Regarding Claim 17, modified Brull discloses the method according to claim 16, further including administering a calibration signal with the nerve stimulation device and recording a baseline muscle response with the recording (“Another example method for assessing neuromuscular blockade in a subject having been administered a muscle relaxant agent includes stimulating a motor nerve to cause a first and a subsequent evoked muscle responses and recording the first and subsequent evoked muscle responses. A peak of the first and subsequent recorded evoked muscle responses are identified and a subsequent peak of the first and subsequent recorded evoked muscle responses are identified.”, [0036]; also see [0021], [0026]); and comparing subsequent recorded muscle responses to the baseline muscle response (“The peak-to-peak amplitude of the first recorded evoked muscle response and the peak-to-peak amplitude of the subsequent recorded evoked muscle response are determined. The peak-to-peak amplitudes are compared…”, [0036]).
Modified Brull discloses the claimed invention except for expressly disclosing administering a calibration signal with the nerve stimulation device prior to the patient receiving a first dose of paralysis agent. However, Hulvershorn teaches administering a calibration signal with the nerve stimulation device (“The monitor 101 can include a calibration routine that gradually raises the stimulation current applied to the patient through the lead assembly 105 until further increases in current do not result in a larger muscle twitch”, [0070]) prior to the patient receiving a first dose of paralysis agent (“In operation, the calibration should be performed on the patient before administering paralyzing drugs”, [0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the calibration signal of Brull prior to the patient receiving a first dose of paralysis agent as taught by Hulvershorn, because Hulvershorn teaches this procedure has a reasonable expectation of success (“In operation, the calibration should be performed on the patient before administering paralyzing drugs”, [0070]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Jiang (US 20160045746 Al), relevant to Claim 7 ([0075]-[0076]).
See Fischell et al (US 6016449), relevant to Claims 1 and 16 (22:37-52).
See Kiani et al (US 20110137297 Al).
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791