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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 16, 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on December 16, 2025. As directed by the amendment: claim(s) 1, 9, and 16 have been amended, claim(s) 10 have been cancelled, and claim(s) 17-18 have been added. Thus, claims 1-9 and 11-18 are currently pending in the application.
Response to Arguments
Applicant's arguments filed December 16, 2025 have been fully considered but they are not persuasive. In regards to the 35 U.S.C. 101 rejection of the claims the applicant first argues, that the steps are not mental processes or mathematical concepts performed in the abstract, but rather require specific physical actions and configurations. The examiner respectfully disagrees. The claims simplified are essentially stimulating, recording, utilizing an algorithm and other mathematical operations to generate a result, then displaying this result. Per the MPEP 2106.04(a) “a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)”. The claims fits the same “formula” as an abstract idea as detailed in the MPEP 2106.04(a) as cited above. This is merely utilizing additional elements that are generic and commercially available, as the claims and instant specification fail to require any specialty equipment to perform the abstract idea.
The applicant next argues that the method is implemented in the context of a particular machine and field of use. The examiner respectfully disagrees. The applicant has not detailed how this is a particular machine, rather these are generic computer parts (i.e. processors) and data collecting sensors (i.e. electrodes) that are implementing the abstract idea. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
Lastly, the applicant argues that the claim limitations improve the functioning of the monitoring technology itself. The applicant argues that the claimed method applies a sequential, conditional analysis keyed to artifact morphology. The examiner respectfully disagrees. The applicant details that the resulting values are cleaner averages without distorting the underlying response morphology; however, they have not shown the improvement as compared to other methods. “A claim that recites an abstract idea must include ‘additional features’ to ensure ‘that the [claim] is more than a drafting effort designed to monopolize the [abstract idea]” (quoting Mayo, 566 U.S. at 77). Therefore, the examiner is not convinced and the 35 U.S.C. 101 rejection is maintained.
Applicant’s arguments, see pgs. 14-19, filed December 16, 2025, with respect to 35 U.S.C. 103 rejection of the claims have been fully considered and are persuasive. The 35 U.S.C. 103 rejection of the claims has been withdrawn.
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 1-9 and 11-18 are rejected under 35 U.S.C. 101 because the claimed invention details a system and process (Step 1) directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106.04, each of Claims 1-9 and 11-18 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of Claims 1-9 and 11-18 recites at least one step or instruction for determining ventilatory threshold for a subject, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106.04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I). Accordingly, each of Claims 1-9 and 11-18 recites an abstract idea.
Specifically, Claim 1 recites
A method for identifying and eliminating signals having non- physiological artifact noise from an averaged evoked potential signal in a patient during an intraoperative procedure, the method comprising:
stimulating, via a stimulating electrode coupled to an arm and/or a leg of the patient, one or more nerves of the nervous system in the patient (additional element)
recording, by a recording electrode couple to a head, neck, spine, arms, legs, trunk, Erb’s point and/or torso of the patient, (additional element) an electrophysiological response comprising a plurality of resultant waveforms generated by a nervous system of the patient, resulting from stimulation of one or more nerves of the nervous system; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
receiving, by a processor of a medical monitoring system coupled to the stimulating electrode and the recording electrode, the electrophysiological response (additional element);
executing, by the processor and in real time, an automated evoked potential analysis algorithm for monitoring, detecting, identifying and eliminating non-physiological artifact noise in a physiological system from which evoked potentials or ensemble averages of the evoked potentials are obtained, the automated evoked potential analysis algorithm operating on a post-stimulus analysis window of each resultant waveform; (mathematical relationships, mathematical formulas or equations, mathematical calculations as detailed in MPEP 2106.04(a)(2)(I)) and/or observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
detecting whether a non-physiological artifact noise is present in at least one resultant waveform by identifying in the resultant waveform at least one characteristic representative of a signal having the non-physiological artifact noise; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
classifying the at least one resultant waveform as an artifact signal if the non-physiological artifact noise is present; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
removing the artifact signal from the plurality of resultant waveforms; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
generating an averaged evoked potential signal from the plurality of resultant waveforms; and (mathematical relationships, mathematical formulas or equations, mathematical calculations as detailed in MPEP 2106.04(a)(2)(I)) and/or observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
generating positioning effect information about the patient using the averaged evoked potential signal (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
transmitting the positioning-effect information to at least one display(additional element) and/or alert system (additional element) and/or feeding the information to other devices in a surgical environment to identify pacemaker activity (additional element).
Similarly, Claim 11 recites
An apparatus for monitoring, detecting, identifying, and eliminating non-physiological artifact noise in the physiological system from which the evoked potentials or ensemble averages are obtained, wherein the apparatus is configured to implement the method of claim 1 so as to identify artifacts in the plurality of resultant waveforms and reject those resultant waveforms that contain such artifacts from the averaged evoked potential signal (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)).
Additionally, Claim 17 details
A method for improving a medical monitoring system by identifying and eliminating signals having non-physiological artifact noise from an averaged evoked potential signal in a patient, the method comprising:
stimulating, by a stimulating electrode, one or more nerves of the nervous system in the patient (additional element)
recording, by a recording electrode (additional element), an electrophysiological response comprising a plurality of resultant waveforms generated by a nervous system of the patient, the electrophysiological response generated by the stimulation-of one or more nerves of the nervous system; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
receiving, by a processor coupled to the stimulating electrode and the recording electrode, the electrophysiological response (additional element);
executing, by the processor, an automated evoked potential analysis algorithm for monitoring, detecting, identifying and eliminating non-physiological artifact noise in a physiological system from which evoked potentials or ensemble averages of the evoked potentials are obtained, the automated evoked potential analysis algorithm operating on a post-stimulus analysis window of each resultant waveform; (mathematical relationships, mathematical formulas or equations, mathematical calculations as detailed in MPEP 2106.04(a)(2)(I)) and/or observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
detecting whether a non-physiological artifact noise is present in at least one resultant waveform by identifying in the resultant waveform at least one characteristic representative of a signal having the non-physiological artifact noise; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
classifying the at least one resultant waveform as an artifact signal if the non-physiological artifact noise is present; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
removing the artifact signal from the plurality of resultant waveforms; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
generating an averaged evoked potential signal from the plurality of resultant waveforms; and (mathematical relationships, mathematical formulas or equations, mathematical calculations as detailed in MPEP 2106.04(a)(2)(I)) and/or observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
generating positioning effect information about the patient using the averaged evoked potential signal (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
Additionally, Claim 18 details
A non-transitory computer-readable medium storing instructions that, when executed by one or more processors of a medical monitoring system operatively coupled to at least one stimulating electrode and at least one recording electrode during an intraoperative procedure, cause the system to perform a method comprising:
delivering, via the at least one stimulating electrode coupled to an arm and/or a leg of a patient, electrical stimulation to one or more nerves of the patient (additional element)
acquiring, via the at least one recording electrode (additional element) coupled to a head, neck, spine, arms, legs, trunk, Erb’s point and/or torso of the patient, an electrophysiological response comprising a plurality of stimulus-locked resultant waveforms generated by a nervous system of the patient, in response to the electrical stimulation (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
receiving, by the medical monitoring system, the electrophysiological response (additional element);
executing, in real time, an automated evoked potential analysis algorithm operating on a post-stimulus analysis window of each resultant waveform to monitor, detect, identify and eliminate non-physiological artifact noise in a physiological system from which evoked potentials or ensemble averages of the evoked potentials are obtained, the automated evoked potential analysis algorithm being configured to: (mathematical relationships, mathematical formulas or equations, mathematical calculations as detailed in MPEP 2106.04(a)(2)(I)) and/or observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
detect whether non-physiological artifact noise is present in a given resultant waveform by identifying in the resultant waveform at least a first characteristic; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
classify the given resultant waveform as an artifact signal when the non-physiological artifact noise is detected; and (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
remove the artifact signal from the plurality of stimulus-locked resultant waveforms by excluding the classified resultant waveform from those used to compute an average; (mathematical relationships, mathematical formulas or equations, mathematical calculations as detailed in MPEP 2106.04(a)(2)(I)) and/or observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
generating, from remaining ones of the plurality of stimulus-locked resultant waveforms in which the artifact signal is not present, an averaged evoked potential signal that represents a neurophysiologic response of the patient; and (mathematical relationships, mathematical formulas or equations, mathematical calculations as detailed in MPEP 2106.04(a)(2)(I)) and/or observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
generating positioning-effect information about the patient using the averaged evoked potential signal (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)); and
transmitting the positioning-effect information to at least one display (additional element) and/or alert system (additional element) and/or feeding the positioning-effect information to other devices in a surgical environment to identify a presence of pacemaker activity (additional element).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in each of independent Claims 1, 11, 17 and 18 (and their respective dependent Claims 2-9 and 12-16) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1, 11, 17 and 18), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of: stimulating electrode, recording electrode, processor, display, alert system and other devices in a surgical environment are generic and used for data gathering adding insignificant extra-solution activity to the judicial exception in independent Claims 1, 11, 17 and 18 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1, 11, 17 and 18 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., external programming device or computer as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 11, 17 and 18 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1, 11, 17 and 18 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claims 1-9 and 11-18 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims require the additional elements of: stimulating electrode, recording electrode, processor, display, alert system and other devices in a surgical environment. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s instant specification, [0037] details that the invention utilizes suitable electrodes which is a generic statement that details that these electrodes are generically available electrodes for either stimulation and/or recording. Per Applicant’s instant specification, [0056]-[0059] and [0076] details the use of a processor or computer system comprising one or a plurality of processors specifically in [0056] that it could be a computing device, communications device, a personal digital assistant, personal computer, and etc. with such generality that they are generic and commercially available. Further, in applicant’s specification [0058] and [0062] the display (and also the alert system as combined with the display as detailed in Fig 7 and [0050]-[0051]) may be part of the computer system or be a separate display unit as generic computer parts that can be combined to create a computer display or separate unit. Lastly, the claims detail other devices in the surgical environment and the instant specification details in [0056] and [0060] may be other computers or similar devices for allowing computer programs to be loaded with such generality that they are generic and commercially available.
Accordingly, in light of Applicant’s specification, the claimed term processor is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for computers. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1, 11, 17 and 18 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method and system of Claims 1-9 and 11-18 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 11, 17 and 18 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 1-9 and 11-18 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-9 and 11-18 are not patent eligible and rejected under 35 U.S.C. 101.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jessandra Hough February 13, 2026
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796