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 § 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.
Claims 1,3-8, 11, 13-18, and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 13 follows.
Regarding claim 13, the claim recites a series of steps or acts, determining the received signal as either a true evoked EMG signal or not true evoked EMG. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of executing, via the processor, the analysis program to analyze the EMG signal according to the EMG classification criteria to determine whether the received EMG signal is either a true evoked EMG signal resulting from the electrical stimulation or a not true evoked EMG. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 13 recites outputting to a user the determination during the surgical procedure, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The output of the determination value does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the outputted determination, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of delivering electrical stimulation, receiving a signal from a sensor on a subject; recalling an analysis program and classification criteria; and executing the program to analyze the received signal. Receiving a sensor signal and executing a program to analyze the signal is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the receiving, recalling and executing steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. The stimulator, sensor, and processor are all generic devices used to perform these insignificant resolution activities. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited processor is a generic processor configured to perform pre-solutional data gathering activity, extra-solution activity, and the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite abstract ideas in the form of mental processes, and insignificant extra-solution activity. The identifying and determining steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
Claim(s) 1, 5-7, 11, 13, 16-17, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelleher (US 20040199084 A1 – previously cited) in view of Navalgund (US 20200107781 A1) in view of Roodaki (US 20250160996 A1 – previously cited) in view of Brunnett (US 20100145221 A1).
In regards to claim 1 Kelleher teaches a system operable during a surgical procedure ([0009] “The present invention provides methods and apparatus for informing an operator that a surgical tool or probe is approaching a nerve”) to determine a signal as a true or non-true evoked electromyography (EMG), the system comprising:
a stimulation instrument configured to deliver electrical stimulation to a nerve of a subject ([0086] stimulus electrodes 11 and 13);
at least one electromyography (EMG) sensor configured to sense an EMG signal from musculature innervated by the nerve ([0054] In a preferred aspect, neuro-muscular (i.e., EMG), responses to the stimulus pulse by muscles coupled to nerves near the stimulating electrode are detected by electrodes positioned at each of a plurality of myotome locations);
a memory system having stored thereon the analysis program ([0098] processor inherently has a memory system).
a processor ([0098]) operable to execute instructions to: eceive the EMG signal from the at least one EMG sensor on a subject, the EMG signal representing a muscle response of the subject to the electrical stimulation delivered by the stimulation instrument ([0092] processor inherently receives data to analyze it);
execute the analysis program to analyze the received signal ([0092] threshold detector is an analysis program);
determine the received signal as either a true evoked EMG signal or not true evoked EMG signal based on executing the analysis program ([0092] determines true EMG or noise signal)
and output to a user the determination during the surgical procedure ([0093] alarm would be triggered indicating that excess noise is present on that particular channel; [0009] method is used during surgery ).
Kelleher fails to explicitly teach what kind of algorithm is used to carry out the true/false EMG determination. Navalgund teaches training and using a machine learning model to classify EMG signals as being true or false. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the system of Kelleher to use a machine learning model trained with training data to carry out the true/false EMG determination like the system of Navalgund. Doing so would merely be choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Kelleher/Navalgund fails to explicitly teach EMG classification criteria defined at least in part based on a type of the surgical procedure and at least one of a nerve or muscle target associated with stimulation by the stimulation instrument; and executing the analysis program to analyze the EMG signal according to the EMG classification criteria. Roodaki teaches choosing a machine learning model based on the type of surgery being performed ([0022]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the system of Kelleher/Navalgund to include different machine learning methods for different types/phases of surgery and choose the method depending on the surgery type/phase like the system of Roodaki in order to improve accuracy and take surgery type into consideration (Roodaki [0021]) when classifying the EMG as true or false.
Kelleher/Navalgund/Roodaki fails to explicitly teach EMG classification criteria defined at least in part based on at least one of a nerve or muscle target associated with stimulation by the stimulation instrument. Brunnett teaches classification criteria defined at least in part based on at least one of a nerve or muscle target ([0085] “In some embodiments, the neurogenic response waveform is also correlated relative to a baseline response pattern of the target nerve to evaluate changes in the response of the nerve compared to the responses occurring prior to surgery”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the training data of Kelleher/Navalgund/Roodaki to include baseline true EMG data from a target nerve like the system of Brunnett in order to evaluate changes in the response of the nerve compared to the responses occurring prior to surgery.
In regards to claim 5 Kelleher teaches the system of Claim 1, further comprising: at least one of an audible output system, a visual output system, a haptic output system, or combinations thereof as the output to the user; wherein the output is made by at least one of the audible output system, the visual output system, the haptic output system, or combinations thereof (Kelleher [0028] [0093] alarm is an audible output system).
In regards to claim 6 modified Kelleher teaches the system of Claim 1, wherein the analysis program includes instructions to determine the presence of at least one attribute of the signal that is indicative of the true evoked EMG (Kelleher [0092] attribute is biphasic wave form).
In regards to claim 7 modified Kelleher teaches the system of Claim 6, wherein the analysis program includes instructions to identify the presence of at least a waveform of the received signal as the at least one attribute of the signal that is indicative of the true evoked EMG (Kelleher [0092] attribute is biphasic waveform).
In regards to claim 11 modified Kelleher teaches the system of Claim 5, wherein the at least one attribute includes a Waveform ([0092] attribute is biphasic waveform).
In regards to claim 13 Kelleher teaches a method of operating an intraoperative nerve monitoring system during a surgical procedure to determine a signal that is a true or not true evoked electromyography (EMG), the method comprising ([0009] “The present invention provides methods and apparatus for informing an operator that a surgical tool or probe is approaching a nerve”):
delivering, via a stimulation instrument, electrical stimulation to a nerve of a subject during the surgical procedure ([0086] stimulus electrodes 11 and 13);
sensing, via at least one electromyography (EMG) sensor disposed on the subject, an EMG signal from musculature innervated by the nerve, the EMG signal representing a muscle response of the subject to the electrical stimulation ([0054] In a preferred aspect, neuro-muscular (i.e., EMG), responses to the stimulus pulse by muscles coupled to nerves near the stimulating electrode are detected by electrodes positioned at each of a plurality of myotome locations);
a memory system having stored thereon the analysis program ([0098] processor inherently has a memory system).
executing the analysis program to analyze the received signal ([0092] threshold detector is an analysis program);
determining the received signal as either a true evoked EMG signal or not true evoked EMG signal based on executing the analysis program (Kelleher [0092] determines true EMG or noise signal)
and outputing to a user the determination during the surgical procedure ([0093] alarm would be triggered indicating that excess noise is present on that particular channel; [0009] method is used during surgery ).
Kelleher fails to explicitly teach recalling an analysis program. However, it would be obvious to a person of ordinary skill in the art to come to the conclusion that in order to execute the program the method would need to recall it.
Kelleher fails to explicitly teach what kind of algorithm is used to carry out the true/false EMG determination. Navalgund teaches training and using a machine learning model to classify EMG signals as being true or false ([0102] “FIG. 47 shows a flow diagram of a method of extracting valid gastrointestinal tract EMG data from a raw time series data set using a machine learning model trained to, at least in part, identify true rhythmic gastrointestinal activity”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of Kelleher to use a machine learning model trained with training data to carry out the true/false EMG determination like the system of Navalgund. Doing so would merely be choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Kelleher/Navalgund fails to explicitly teach EMG classification criteria defined at least in part based on a type of the surgical procedure and at least one of a nerve or muscle target associated with stimulation by the stimulation instrument; and executing the analysis program to analyze the EMG signal according to the EMG classification criteria. Roodaki teaches choosing a machine learning model based on the type of surgery being performed ([0022]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of Kelleher/Navalgund to include different machine learning methods for different types/phases of surgery and choose the method depending on the surgery type/phase like the system of Roodaki in order to improve accuracy and take surgery type into consideration (Roodaki [0021]) when classifying the EMG as true or false.
Kelleher/Navalgund/Roodaki fails to explicitly teach EMG classification criteria defined at least in part based on at least one of a nerve or muscle target associated with stimulation by the stimulation instrument. Brunnett teaches classification criteria defined at least in part based on at least one of a nerve or muscle target ([0085] “In some embodiments, the neurogenic response waveform is also correlated relative to a baseline response pattern of the target nerve to evaluate changes in the response of the nerve compared to the responses occurring prior to surgery”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the training data of Kelleher/Navalgund/Roodaki to include baseline true EMG data from a target nerve like the system of Brunnett in order to evaluate changes in the response of the nerve compared to the responses occurring prior to surgery.
In regards to claim 16 modified Kelleher teaches the method of Claim 13, wherein the analysis program includes instructions to determine the presence of at least one attribute of the signal that is indicative of the true evoked EMG (Kelleher [0092] attribute is biphasic wave form).
In regards to claim 17 modified Kelleher teaches the method of Claim 16, wherein the analysis program includes instructions to identify the presence of at least one attribute of the signal that is indicative of the true evoked EMG (Kelleher [0092] attribute is biphasic wave form).
In regards to claim 21 modified Kelleher teaches the method of Claim 16, wherein the at least one attribute includes at least a Waveform (Kelleher [0092] attribute is biphasic wave form).
In regards to claim 22 modified Kelleher teaches the method of Claim 13, wherein the analysis program is a trained machine learning program (Navalgund [0102]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelleher (US 20040199084 A1 – previously cited) in view of Navalgund (US 20200107781 A1) in view of Roodaki (US 20250160996 A1 – previously cited) in view of Brunnett (US 20100145221 A1) as applied to claim 1, in view of Cha (US 20220071546 A1 - previously cited).
In regards to claim 3 modified Kelleher teaches system of claim 1, including an LCD display (Kelleher [0098]). Modified Kelleher fails to teach a system wherein the processor outputs to the user only the determination of the true evoked EMG signal. Cha teaches teach a system wherein the processor outputs “true” when a signal meets predetermined criteria ([0082] only displays artifact free epochs). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of modified Kelleher to output a value of “true” when the EMG signal is determined to be a true evoked EMG signal. It would have also been obvious to display this value on the display of Kelleher. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of indicating to the user that the EMG is a true evoked EMG.
Claim(s) 4, 8, 14-15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelleher (US 20040199084 A1 – previously cited) in view of Navalgund (US 20200107781 A1) in view of Roodaki (US 20250160996 A1 – previously cited) in view of Brunnett (US 20100145221 A1) as applied to claims 1, 6, and 16, in view of Prass (US 20030088185 A1 – previously cited).
In regards to claim 4 modified Kelleher teaches the system of claim 1, including an LCD display ([0098]). Modified Kelleher fails to teach a system wherein the processor outputs to the user both the determination of the true evoked EMG signal and the not true evoked EMG signal. Prass teaches determining if an EMG is a "true EMG" or "artifact" and producing an output signal that indicates the determination ([0048-0050]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the program of modified Kelleher to send a signal indicative of if the EMG determination like the method of Prass. It would also be obvious to display this output on the display of Kelleher. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of indicating to the user if the EMG is a true evoked EMG or merely a noise signal.
In regards to claim 8 modified Kelleher teaches the system of Claim 6. Modified Keller fails to teach a system wherein the analysis program determines the presence of a plurality of attributes of the signal that is indicative of the true evoked EMG. Prass teaches determining an EMG signal is a true EMG signal by determining if supra threshold activity was determined in the EMG channel ([0048]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the program of modified Kelleher to use supra threshold activity in addition to the waveform to determine if the evoked EMG is a true EMG. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of determining an EMG is a true EMG using multiple attributes.
In regards to claim 14 modified Kelleher teaches the method of claim 13, including using an LCD display to display information ([0098]). Modified Kelleher fails to teach a system wherein the processor outputs to the user both the determination of the true evoked EMG signal and the not true evoked EMG signal. Prass teaches determining if an EMG is a "true EMG" or "artifact" and producing an output signal that indicates the determination ([0048-0050]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Kelleher to send a signal indicative of if the EMG determination like the method of Prass. It would also be obvious to display this output using the display of modified Kelleher. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of indicating to the user if the EMG is a true evoked EMG or merely a noise signal.
In regards to claim 15 modified Kelleher teaches the method of Claim 14, wherein the output includes at least one of an audible output, a visual output, a haptic output, or combinations thereof (Kelleher [0028] [0093] alarm is an audible output system).
In regards to claim 18 modified Kelleher teaches the method of Claim 16. Modified Keller fails to teach a method wherein the analysis program determines the presence of a plurality of attributes of the signal that is indicative of the true evoked EMG. Prass teaches determining an EMG signal is a true EMG signal by determining if supra threshold activity was determined in the EMG channel ([0048]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Kelleher to use supra threshold activity in addition to the waveform to determine if the evoked EMG is a true EMG. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of determining an EMG is a true EMG using multiple attributes.
Response to Arguments
Applicant’s arguments, see remarks, filed 12/17/2025, with respect to the 35 U.S.C. 112(a)/(b) rejections of claims 9, 12, and 19 have been fully considered and are persuasive. The 35 U.S.C. 112(a)/(b) rejections of claims 9, 12, and 19 have been withdrawn.
Applicant's arguments filed 12/17/2025 in regards to the 35 U.S.C. 101 rejections of claims 1-22 have been fully considered but they are not persuasive. In regards to the applicant’s arguments regarding Prong One, the features recited in the amendment are still a general stimulator, sensor, and processor configured to perform pre-solutional data gathering activity, extra-solution activity, and the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. In regards to Prong Two the provided specification fails to provide evidence of said improvement.
Applicant’s arguments, see remarks, filed 12/17/2025, with respect to the 35 U.S.C. 102 rejection(s) of claim(s) 1 and 13 under Kheller have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kelleher (US 20040199084 A1 – previously cited) in view of Navalgund (US 20200107781 A1) in view of Roodaki (US 20250160996 A1 – previously cited) in view of Brunnett (US 20100145221 A1).
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 LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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/LUCY EPPERT/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791