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 .
Response to Amendment
Applicant’s amendment, filed 12 February 2026, is acknowledged. Claims 1, 7, 8, and 10 are amended. Claims 4 and 9 are cancelled. Claim 11 is new.
Claims 1-3, 5-8 and 10-11 are pending in the application.
Response to Arguments
Applicant’s arguments, filed 12 February 2026, with respect to the 35 USC 112(f) interpretation of claim 1 have been fully considered and are persuasive in light of the amendment. The 35 USC 112(f) interpretation of claim 1 has been withdrawn.
Applicant’s arguments, filed 12 February 2026, with respect to the 35 USC 112(b) rejections of claims 1-10 have been fully considered and are persuasive in light of the amendment. The 35 USC 112(b) rejections of claims 1-10 have been withdrawn.
Applicant's arguments regarding the 35 USC 101 rejection of claim 10 has been fully considered but they are not persuasive. Applicant argues that a person cannot detect, by signals received from detection electrodes, as a first peak value, an amplitude peak value of an electric signal that is based on a stimulation response of the muscle or detect, by the signals received from detection electrodes, as a second peak value, an amplitude peak value of an electric signal that is based on a stimulation response of the muscle due to an electrical stimulation of a second stimulation current value that is varied, which examiner disagrees with. If signals presented on a display or a printout device, the signals can be very easily detected by a person. The term “detect” is extremely broad and does not limit a person from visually detecting signals presented visually. The limitation only require that a person sees the signals. Further the steps only require a person to detect and compare values. The steps do not require the application of current nor do they require any steps that cannot be accomplished by a person. A person can watch a display as the first stimulation is applied, write down the peak value, and repeat for the second stimulation. A person can further mentally compare the two values and determine if the supramaximal is reached mentally. The same can be applied to initial screening because the process does not require the application of the current, only the comparison of the values.
Examiner notes the amended limitation “comprising a processor” does not integrate a judicial exception into a practical application per MPEP 2106.05(f).
Applicant’s arguments, with regard to the 35 USC 103 rejections of claims 1-3, 5-8 and 10, have been fully considered and are persuasive in light of the amendment. The 35 USC 103 rejections of claims 1-3, 5-8 and 10 have been withdrawn.
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 1-3, 5-8 and 10-11 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 recites a processor that is configured to perform a series of steps wherein the steps comprise "the initial screening comprises comparing a first testing amplitude peak value of the electric signal that is based on the stimulation response of the muscle due to the electrical stimulation of the initial stimulation current value, and a second testing amplitude peak value of the electric signal that is based on the stimulation response of the muscle due to the electrical stimulation of the stimulation current value that is obtained by decreasing the initial stimulation current value by the value corresponding to the step current value" in lines 29-34. The limitations recited are nearly identical to those in lines 15-28. Both series of steps start with the initial stimulation current value, apply the stimulation, record the response, change the stimulation current value by the predetermined step current, apply the new stimulation and record the response. The initial screening is then used to determine the current value variable process, while the steps in lines 15-28 result in the detection of a stimulation current value of a maximal stimulation of the subject. The claim is indefinite because it does not appear that the first testing amplitude peak value is different from the first peak value, nor the second testing amplitude peak value from the second peak value. Further, while the specification, including Figure 2, recites a plurality of applications of current to the patient until the supramaximal value is found, lines 15-28 do not. Therefore, it appears the processor executes the initial screening process twice and arrives at the supramaximal current value without making the additional changes to the current value beyond the initial screening process, rendering the claim unclear.
Claims 2-3 and 5-8 inherit the same deficiency.
Claim 10 recites the limitation "the initial screening comprises comparing a first testing amplitude peak value of the electric signal that is based on the stimulation response of the muscle due to the electrical stimulation of the initial stimulation current value, and a second testing amplitude peak value of the electric signal that is based on the stimulation response of the muscle due to the electrical stimulation of the stimulation current value that is obtained by decreasing the initial stimulation current value by the value corresponding to the step current value" in lines 28-33. The limitations recited are nearly identical to those in lines 14-27. Both processes start with the initial stimulation current value, apply the stimulation, record the response, change the stimulation current value by the predetermined step current, apply the new stimulation and record the response. The initial screening is then used to determine the current value variable process, while the steps in lines 14-27 result in the detection of a stimulation current value of a maximal stimulation of the subject. The claim is indefinite because it does not appear that the first testing amplitude peak value is different from the first peak value, nor the second testing amplitude peak value from the second peak value. Further, while the specification, including Figure 2, recites a plurality of applications of current to the patient until the supramaximal value is found, lines 14-27 do not. Therefore, it appears the method executes the initial screening process twice and arrives at the supramaximal current value without making the additional changes to the current value beyond the initial screening process, rendering the claim unclear.
Claim 11 inherits the same deficiency.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 7 and 8 are dependent on claim 14, which is not included in the instant application. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more. The claim(s) recite(s) “performing an initial screening”, “setting an initial stimulation current value”, “detecting, as a first peak value”, “detecting, as a second peak value,” and “detecting a stimulation current value”. This judicial exception is not integrated into a practical application because the steps can be accomplished by person through a mental process. The steps do not positively recite applying the current, but merely detecting signals and making a determination. As the step of detecting can be accomplished by visually seeing signals on a display, this does not require anything that would integrate the judicial exception into a practical application. The step of “setting an initial stimulation current value” may integrate the judicial exception into a practical application if additional structure to the device/system was provided. As currently recited, it can be broadly interpreted as a mental step. Figure 1 of the instant application provides for a muscle relaxation monitoring apparatus, including a stimulation generator and a signal receiver.
Allowable Subject Matter
Claims 1-3 and 5-6 would be allowable if rewritten or amended 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.
Claims 7 and 8 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, and 35 U.S.C. 112(d) as set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 10 and 11 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 1 recites a muscle relaxation monitoring apparatus that comprises a processor configured to perform a series of steps comprising an initial screening wherein a first testing amplitude peak value is acquired based on the initial stimulation current value and a second testing amplitude peak value is acquired based on a current value that is obtained by decreasing the initial stimulation current value by the predetermined step current value and based on a comparison of the first testing amplitude peak value and the second testing amplitude peak value a current value variable process is determined. The current value variable process is then used to find a stimulation current value of a maximal stimulation of the subject.
Claim 10 recites calibration processing method for acquiring a stimulation current value of a supramaximal stimulation exceeding a maximal stimulation of a muscle of a subject, wherein the method comprises an initial screening wherein a first testing amplitude peak value is acquired based on the initial stimulation current value and a second testing amplitude peak value is acquired based on a current value that is obtained by decreasing the initial stimulation current value by the predetermined step current value and based on a comparison of the first testing amplitude peak value and the second testing amplitude peak value a current value variable process is determined. The current value variable process is then used to find a stimulation current value of a maximal stimulation of the subject.
The prior art cited, Brull (US20130204155A1) and Hulvershorn (US20190223764A1), cite methods and steps of finding a maximal stimulation of the subject, but do so by starting at a predetermined initial current and increasing the current until the maximal stimulation is found. The prior art does not teach decreasing the current value to find a stimulation current value of a maximal stimulation.
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 Marc D Honrath whose telephone number is (571)272-6219. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791
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