DETAILED ACTION
Claims 1-20 are hereby under examination.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/30/2024 is being considered by the examiner.
Claim Objections
Claims 7-8, 11-12, 14, 17, and 19 are objected to because of the following informalities:
Regarding claim 7, line 2 recites “an output”, however it appears it should read --the signal output-- (emphasis added) to maintain consistent claim language.
Regarding claim 7, lines 2-3 recite “a stimulating electrode”, however it appears it should read --the stimulating electrode-- (emphasis added).
Regarding claim 8, line 2 recites “a recording electrode”, however it appears it should read --the recording electrode-- (emphasis added).
Regarding claim 8, line 3 recites “an input”, however it appears it should read --the signal input-- (emphasis added) to maintain consistent claim language.
Regarding claim 11, line 2 recites “a stimulating electrode”, however it appears it should read --the stimulating electrode-- (emphasis added).
Regarding claim 12, line 2 recites “a recording electrode”, however it appears it should read --the recording electrode-- (emphasis added).
Regarding claim 14, line 1 recites “a positioning effect”, however it appears it should read --the positioning effect-- (emphasis added).
Regarding claim 17, line 1 recites “a user interface”, however it appears it should read --the user interface-- (emphasis added).
Regarding claim 19, line 2 recites “a stimulating electrode”, however it appears it should read --the stimulating electrode-- (emphasis added).
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 9, 10, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 9, the claim recites “delivering the electrical stimulus comprises delivering, via a wet gel electrode, the electrical stimulus”. However, claim 1 recites “delivering, via the stimulating electrode, the electrical stimulus”. In light of the specification, it is currently unclear if claim 9 is further defining “the stimulating electrode” to be “a wet gel electrode”, or if a second electrical stimulus is delivered via a wet gel electrode. For the purposes of examination, claim 9 is further defining “the stimulating electrode” as “a wet gel electrode”. It is recommended to the Applicant to amend the claims to clearly link the two claimed elements.
Regarding claim 10, the claim recites “receiving, via a wet gel electrode, the resultant electrical waveform”. However, claim 1 recites “recording, via the recording electrode, a resultant electrical waveform”. In light of the specification, it is currently unclear if claim 10 is further defining “the recording electrode” to be “a wet gel electrode”, or if a second resultant electrical waveform is recorded by a wet gel electrode. For the purposes of examination, claim 10 is further defining “the recording electrode” as “a wet gel electrode”. It is recommended to the Applicant to amend the claims to clearly link the two claimed elements.
Regarding claim 17, line 1 recites “sending a data output to a user interface”. However, claim 1 recites “a data output configured to send processed data to a user interface”. In light of the specification, it is currently unclear if “a data output” recited in claim 17 is the same as, related to, or different from “a data output recited in claim 1”. It appears the two elements are related, however, claim 1 implies “a data output” as structure and claim 17 implies “a data output” as a signal. For the purposes of examination, “a data output’ recited in claim 17 is being interpreted as being related to “a data output” recited in claim 1. It is recommended to the Applicant to amend the claims to clearly link or clearly differentiate between the two elements.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claim 1:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites an abstract idea. In particular, the claim recites the following:
Detecting a positioning effect at least in part by comparing the processed resultant electrical waveform to a baseline and, if the processed resultant electrical waveform is determined to be good, a number of good responses is increased by one; and if the processed resultant electrical waveform is determined to be either bad or undetermined, a number of bad responses is increased by one.
These elements recited in claim 1 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations; and/or (2) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Comparing a waveform to a baseline to determine if the waveform is good, and tallying the number of good responses and bad responses is drawn to a mathematical concept, for example, by calculating if the waveform is above or below a baseline threshold and/or if a deviation of the waveform is within certain thresholds. Alternatively and/or additionally, comparing a waveform to a baseline, and tallying the number of good responses and bad responses is drawn to a mental process that can be practically performed in the human mind, with the aid of pen and paper. For example, a person of ordinary skill in the art can reasonably view waveforms on a piece of paper, compare the waveforms to a baseline, mentally determine if the waveforms are good or bad, and tally the number of good and bad waveforms. There is nothing to suggest an undue level of complexity in the detecting and comparing steps.
Prong Two: Claim 1 does not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “at least one data processor”, “at least one memory”, “automatically”), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “a signal output configured to couple to a stimulating electrode”, “a signal input configured to couple to a recording electrode”, “generating, via the signal output, an electrical stimulus”, “delivering, via the stimulating electrode, the electrical stimulus to a peripheral nerve in the body”, “recording, via the recording electrode, a resultant electrical waveform generated by the body’s nervous system in response to the electrical stimulus”, “processing, via the at least one data processor, the resultant electrical waveform”); the post-solution activity of: (e.g. “an alert is generated if the number of bad responses reaches a bad counter threshold”); using generic data-outputting components (e.g. “a data output configured to send processed data to a user interface”)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, a signal output configured to couple to a stimulating electrode … generating, via the signal output, an electrical stimulus … delivering, via the stimulating electrode, the electrical stimulus to a peripheral nerve in the body …, as disclosed by Buckley et al. (US 9332918 B1) - col. 5, lines 35-57.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, a signal input configured to couple to a recording electrode … recording, via the recording electrode, a resultant electrical waveform generated by the body’s nervous system in response to the electrical stimulus, as disclosed by Buckley et al. (US 9332918 B1) - col. 5, lines 22-45.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, processing, via the at least one data processor, the resultant electrical waveform, as disclosed by Buckley et al. (US 9332918 B1) - col. 8, lines 51-64.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, generating an alert is well-understood, routine, and conventional, as disclosed by Buckley et al. (US 9332918 B1) - col. 9, lines 49-58.
Further, a “data processor” and “instructions stored on at least one memory” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution steps of necessary data gather and/or generic post-solution steps of generating alerts, without reciting structure, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2-20 depend from the independent claim. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“the number of bad responses is set to zero when the number of good responses reaches a good counter threshold” (claim 3), “the baseline comprises a moving baseline comprising a plurality of resultant electrical waveforms” (claim 5), “determining if the additional resultant electrical waveform should be indicated as a good response” (claim 14), “determining if the additional resultant electrical waveform should be indicated as a good response comprises comparing the additional resultant electrical waveform to the baseline” (claim 15)),
Further describe the pre-solution activity (or the structure used for such activity) (“the resultant electrical waveform is recorded at a plurality of peripheral recording sites using a plurality of single electrode units, each single electrode unit comprising a ground electrode, a reference electrode, and a recording electrode” (claim 6), “delivering the electrical stimulus comprises delivering, through a triaxially shielded cable, the electrical stimulus from an output to a stimulating electrode” (claim 7), “recording the resultant electrical waveform comprises receiving the resultant electrical waveform at a recording electrode and sending the resultant electrical waveform through a triaxially shielded cable to an input” (claim 8), “delivering the electrical stimulus comprises delivering, via a wet gel electrode, the electrical stimulus” (claim 9), “recording the resultant electrical waveform comprises receiving, via a wet gel electrode, the resultant electrical waveform” (claim 10), “delivering the electrical stimulus comprises transmitting a plurality of time-locked electrical stimuli via a stimulating electrode positioned on skin of the body, the stimulating electrode in communication with an evoked potential detection device configured to monitor one or more peripheral nerves of the body” (claim 11), “recording the resultant electrical waveform comprises recording, via a recording electrode positioned on skin of the body, a plurality of resultant electrical waveforms, the resultant electrical waveforms generated by the body's nervous system in response to the electrical stimulus” (claim 12), “processing the resultant electrical waveform comprises developing an initial baseline waveform from an average of a plurality of resultant electrical waveforms” (claim 13), “detecting a positioning effect comprises: stimulating an additional electrical stimulus; recording an additional resultant electrical waveform” (claim 14), “updating the baseline to include the additional resultant electrical waveform if the additional resultant electrical waveform is determined to be a good response” (claim 16), “processing the resultant electrical waveform comprises filtering and amplifying the resultant electrical waveform” (claim 18), “the electrical stimulus is delivered with a stimulating electrode; and the resultant electrical waveform is recorded with a plurality of recording electrodes, reference electrodes, and ground electrodes positioned at a plurality of peripheral recording sites; wherein each peripheral recording site of the plurality of peripheral recording sites comprises one ground electrode, one reference electrode, and one recording electrode; and wherein the recording and reference electrodes are positioned between the ground electrode and the stimulating electrode” (claim 19), “at least two of the reference electrode, the recording electrode, and the ground electrode are disposed on a single electrode unit” (claim 20)),
Further describe the post-solution activity (“an alert is generated if the number of good responses reaches a good counter threshold” (claim 2), “a display visually displays a graphic indicating a relative number of good responses and a relative number of bad responses” (claim 4), “sending a data output to a user interface, the data output comprising an indication of whether the positioning effect has been detected” (claim 17)) (recited at a high level of generality).
Per the Berkheimer requirement, the additional elements as recited above are well-understood, routine, and conventional.
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 1-20 are rejected.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 9-10, 12, 14-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Buckley et al. (US 9332918 B1), hereinafter referred to as Buckley, in view of Cho et al. (US 20050119711 A1), hereinafter referred to as Cho.
The claims are generally directed towards an automated method for detecting positioning effect in a body using: at least one data processor configured to execute instructions stored on at least one memory, a signal output configured to couple to a stimulating electrode, a signal input configured to couple to a recording electrode, and a data output configured to send processed data to a user interface, the method comprising: generating, via the signal output, an electrical stimulus; delivering, via the stimulating electrode, the electrical stimulus to a peripheral nerve in the body; recording, via the recording electrode, a resultant electrical waveform generated by the body's nervous system in response to the electrical stimulus; processing, via the at least one data processor, the resultant electrical waveform; and automatically detecting, via the at least one data processor, a positioning effect at least in part by comparing the processed resultant electrical waveform to a baseline and, if the processed resultant electrical waveform is determined to be good, a number of good responses is increased by one; and if the processed resultant electrical waveform is determined to be either bad or undetermined, a number of bad responses is increased by one; wherein, an alert is generated if the number of bad responses reaches a bad counter threshold.
Regarding claim 1, Buckley discloses an automated method for detecting positioning effect in a body using: at least one data processor configured to execute instructions stored on at least one memory, a signal output configured to couple to a stimulating electrode, a signal input configured to couple to a recording electrode, and a data output configured to send processed data to a user interface (Abstract, Fig. 7, col. 1, lines 20-30, “automated test uses electrodes to generate input signals and receive response output signals … detect and prevent intraoperative positioning related neuropathies …”, col. 5, lines 22-57, col. 8, line 51 - col. 9, line 29), the method comprising:
generating, via the signal output, an electrical stimulus (col. 5, lines 35-57, “stimulation electrodes … to stimulate a plurality of peripheral nerves … input subsystem can include … pulse generator … energy source … input system is in electrical communication with the stimulation elements …”, col. 6, lines 40-42, col. 8, line 51 - col. 9, line 3, “pulse generator defines properties of the pulses and generates the actual pulse …”);
delivering, via the stimulating electrode, the electrical stimulus to a peripheral nerve in the body (col. 5, lines 35-57, “stimulation electrodes … to stimulate a plurality of peripheral nerves … input subsystem can include … pulse generator … energy source … input system is in electrical communication with the stimulation elements …”, col. 6, lines 40-42);
recording, via the recording electrode, a resultant electrical waveform generated by the body's nervous system in response to the electrical stimulus (Fig. 8-10F, col. 5, lines 22-45, “recording electrodes … recording electrodes can be configured to record …”, col. 6, lines 44-47);
processing, via the at least one data processor, the resultant electrical waveform (Fig. 7, element 56, element 65, col. 9, lines 49-58, “various filters and other components can be used to reduce signal noise …”); and
automatically detecting, via the at least one data processor, a positioning effect at least in part by comparing the processed resultant electrical waveform to a baseline (col. 1, lines 20-30, col. 5, lines 59-62, “automated by software … detect preset thresholds to signal a change from the baseline reading …”, col. 10, lines 13-19, “baseline signal is used as one input to the comparator … output is compared relative to the baseline …”) and,
wherein, an alert is generated (col. 9, lines 49-58, “alarm decision is made … alarm signal is sent to an output … display, an indicator … a speaker …”).
Buckley teaches indicating an alarm for normal signals and abnormal signals (Fig. 7, col. 11, line 62 - col. 12, line 22). However, Buckley does not explicitly disclose if the processed resultant electrical waveform is determined to be good, a number of good responses is increased by one; and if the processed resultant electrical waveform is determined to be either bad or undetermined, a number of bad responses is increased by one; and wherein, the alarm is generated if the number of bad responses reaches a bad counter threshold.
Cho teaches an analogous method for comparing a signal to a baseline to determine the validity of the signal (Abstract, para. [0014], para. [0052]). Cho further teaches if the processed resultant electrical waveform is determined to be good, a number of good responses is increased by one; and if the processed resultant electrical waveform is determined to be either bad or undetermined, a number of bad responses is increased by one; and wherein, the alarm is generated if the number of bad responses reaches a bad counter threshold (para. [0052-0053], para. [0074-0078]). 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 disclosed by Buckley to additionally count the number of good and bad responses, and generate the alarm if the number of bad responses reaches a bad counter threshold, as taught by Cho. This is because Cho teaches counting a number of good and bad responses allows for a minimum threshold to be crossed before making a determination, ensuring enough data is collected to minimize false responses (para. [0050], para. [0053]).
Regarding claim 2, modified Buckley discloses the method of claim 1, wherein an alert is generated for good responses (Fig. 7, col. 11, line 62 - col. 12, line 22).
However, modified Buckley does not explicitly disclose generating the alert if the number of good responses reaches a good counter threshold.
Cho further teaches generating the alert if the number of responses reaches a counter threshold (para. [0052-0053], para. [0074-0078]). 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 taught by modified Buckley to additionally generate the alert if the number of good responses reaches a good counter threshold, as taught by Cho. This is because Cho teaches counting a number of responses allows for a minimum threshold to be crossed before making a determination or alert, ensuring enough data is collected to minimize false responses (para. [0050], para. [0053]).
Regarding claim 3, modified Buckley discloses the method of claim 1.
However, modified Buckley does not explicitly disclose wherein the number of bad responses is set to zero when the number of good responses reaches a good counter threshold.
Cho further teaches if a number of responses reaches a threshold, the counters are reset (para. [0090], para. [0095]). 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 taught by modified Buckley to additionally set the number of bad responses to zero when the number of food responses reaches a good counter threshold, as taught by Cho. This is because Cho teaches when a threshold is determined, a cycle counter can be reset to continue monitoring, in order to determine if enough data is collected to make a valid determination (para. [0050], para. [0053], para. [0090], para. [0095]).
Regarding claim 4, modified Buckley discloses the method of claim 1, wherein a display visually displays a graphic indicating a relative number of good responses and a relative number of bad responses (col. 11, line 62 - col. 12, line 22, “each SSEP can be displayed for user evaluation … color coded or symbol coded … indicate a normal system and signal, an abnormal signal, or a system error …”).
Regarding claim 9, modified Buckley discloses the method of claim 1, wherein delivering the electrical stimulus comprises delivering, via a wet gel electrode, the electrical stimulus (col. 5, lines 35-45, “stimulation electrodes … gel type electrodes …”).
Regarding claim 10, modified Buckley discloses the method of claim 1, wherein recording the resultant electrical waveform comprises receiving, via a wet gel electrode, the resultant electrical waveform (col. 7, lines 23-28, “recording electrodes are also gel electrodes …”).
Regarding claim 12, modified Buckley discloses the method of claim 1, wherein recording the resultant electrical waveform comprises recording, via a recording electrode positioned on skin of the body, a plurality of resultant electrical waveforms, the resultant electrical waveforms generated by the body's nervous system in response to the electrical stimulus (Fig. 8-10F, col. 6, lines 43-54, “data from the recording electrodes can be processed … continuous monitoring can be performed for an active period …”).
Regarding claim 14, modified Buckley discloses the method of claim 1, wherein detecting a positioning effect comprises: stimulating an additional electrical stimulus; recording an additional resultant electrical waveform; and determining if the additional resultant electrical waveform should be indicated as a good response (Fig. 8-10F, col. 6, lines 43-54, “data from the recording electrodes can be processed … continuous monitoring can be performed for an active period …”).
Regarding claim 15, modified Buckley discloses the method of claim 14, wherein determining if the additional resultant electrical waveform should be indicated as a good response comprises comparing the additional resultant electrical waveform to the baseline (Fig. 8-10F, col. 6, lines 43-54, “data from the recording electrodes can be processed … continuous monitoring can be performed for an active period …”).
Regarding claim 17, modified Buckley discloses the method of claim 1, further comprising sending a data output to a user interface, the data output comprising an indication of whether the positioning effect has been detected (Fig. 8-10F, col. 6, lines 49-53, “changes to the baseline signals deviated from one or more thresholds … an alarm is generated …”).
Regarding claim 18, modified Buckley discloses the method of claim 1, wherein processing the resultant electrical waveform comprises filtering and amplifying the resultant electrical waveform (Fig. 7, col. 8, lines 51-64, “pre-amplifiers …”, col. 9, lines 53-54, “various filters and other components can be used to reduce signal noise”).
Claims 5, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Buckley et al. (US 9332918 B1), hereinafter referred to as Buckley, in view of Cho et al. (US 20050119711 A1), hereinafter referred to as Cho as applied to claim 1 and claim 15 above, and further in view of Higgins et al. (US 20110230785 A1), hereinafter referred to as Higgins.
Regarding claim 5, modified Buckley discloses the method of claim 1.
However, modified Buckley wherein the baseline comprises a moving baseline comprising a plurality of resultant electrical waveforms.
Higgins teaches an analogous method for detecting a positioning effect (Abstract, para. [0029]). Higgins teaches detecting the positioning effect by comparing a processed resultant electrical waveform to a baseline (para. [0038]). Higgins further teaches the baseline comprises a moving baseline comprising a plurality of resultant electrical waveforms (para. [0038], para. [0040]). 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 baseline taught by modified Buckley to explicitly be a moving baseline comprising a plurality of resultant electrical waveforms, as taught by Higgins. This is because Higgins teaches the baseline can be an average of multiple slopes, allowing for more consistent positioning effect determination specific to the patient (para. [0038], para. [0040]).
Regarding claim 13, modified Buckley discloses the method of claim 1.
However, modified Buckley does not explicitly disclose wherein processing the resultant electrical waveform comprises developing an initial baseline waveform from an average of a plurality of resultant electrical waveforms.
Higgins teaches an analogous method for detecting a positioning effect (Abstract, para. [0029]). Higgins teaches detecting the positioning effect by comparing a processed resultant electrical waveform to a baseline (para. [0038]). Higgins further teaches processing the resultant electrical waveform comprises developing an initial baseline waveform from an average of a plurality of resultant electrical waveforms (para. [0038], para. [0040]). 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 taught by modified Buckley to additionally develop an initial baseline waveform from an average of a plurality of resultant electrical waveforms, as taught by Higgins. This is because Higgins teaches developing an initial baseline by averaging allows for more consistent positioning effect determination specific to the patient (para. [0038], para. [0040]).
Regarding claim 16, modified Buckley discloses the method of claim 15.
However, modified Buckley does not explicitly disclose the method further comprises updating the baseline to include the additional resultant electrical waveform if the additional resultant electrical waveform is determined to be a good response.
Higgins teaches an analogous method for detecting a positioning effect (Abstract, para. [0029]). Higgins teaches detecting the positioning effect by comparing a processed resultant electrical waveform to a baseline (para. [0038]). Higgins further teaches updating the baseline to include the additional resultant electrical waveform if the additional resultant electrical waveform is determined to be a good response (para. [0038], para. [0040]). 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 taught by modified Buckley, to additionally update the baseline to include the additional resultant electrical waveform if the additional resultant electrical waveform is determined to be a good response, as taught by Higgins. This is because Higgins teaches average multiple baselines allows for a more consistent positioning effect determination specific to the patient (para. [0038], para. [0040]).
Claims 6, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Buckley et al. (US 9332918 B1), hereinafter referred to as Buckley, in view of Cho et al. (US 20050119711 A1), hereinafter referred to as Cho as applied to claim 1 and claim 19 above, and further in view of Devlin et al. (US 20020183605 A1), hereinafter referred to as Devlin.
Regarding claim 6, modified Buckley discloses the method of claim 1, wherein the resultant electrical waveform is recorded at a plurality of peripheral recording sites using a plurality of single electrode units (col. 5, lines 32-45).
However, modified Buckley does not explicitly disclose each single electrode unit comprising a ground electrode, a reference electrode, and a recording electrode.
Devlin teaches an analogous method for monitoring body phenomena using electrodes (Abstract, para. [0015]). Devlin further teaches an electrode unit comprises a ground electrode, a reference electrode, and a recording electrode (Fig. 11, para. [0046], para. [0063]). 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 electrode units taught by modified Buckley to additionally comprise a ground electrode, a reference electrode, and a recording electrode, as taught by Devlin. This is because Devlin teaches utilizing a ground electrode, a reference electrode, and a recording electrode is a known and predictable method for acquiring a signal (para. [0040]).
Regarding claim 19, modified Buckley discloses the method of claim 1, wherein: the electrical stimulus is delivered with a stimulating electrode (col. 5, lines 35-38); and the resultant electrical waveform is recorded with a plurality of recording electrodes positioned at a plurality of peripheral recording sites (col. 5, lines 33-45); wherein each peripheral recording site of the plurality of peripheral recording sites comprises one recording electrode (col. 5, lines 33-45), wherein electrodes are positioned between the stimulating electrode (col. 3, lines 46-63).
However, modified Buckley does not explicitly disclose the resultant electrical waveform is recorded with a plurality of reference electrodes and ground electrodes, and wherein each peripheral recording site comprises one ground electrode and one reference electrode, and wherein the recording and reference electrodes are positioned between the ground electrode.
Devlin teaches an analogous method for monitoring body phenomena using electrodes (Abstract, para. [0015]). Devlin further teaches a resultant electrical waveform is recorded with a plurality of reference electrodes and ground electrodes, and wherein each peripheral recording site comprises one ground electrode and one reference electrode, and wherein the recording and reference electrodes are positioned between the ground electrode (Fig. 15, para. [0041], para. [0046], para. [0063]). 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 taught by modified Buckley to additionally record the resultant electrical waveform with a plurality of reference electrodes and ground electrodes, and wherein each peripheral recording site comprises one ground electrode and one reference electrode, and wherein the recording and reference electrodes are positioned between the ground electrode, as taught by Devlin. This is because Devlin teaches utilizing a ground electrode, a reference electrode, and a recording electrode is a known and predictable method for acquiring a signal (para. [0040]).
Regarding claim 20, modified Buckley discloses the method of claim 19.
However, modified Buckley does not explicitly disclose wherein at least two of the reference electrode, the recording electrode, and the ground electrode are disposed on a single electrode unit.
Devlin further teaches at least two of the reference electrode, the recording electrode, and the ground electrode are disposed on a single electrode unit (Fig. 1, Fig. 15). 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 taught by modified Buckley to additionally dispose at least two of the reference electrode, thee recording electrode, and the round electrode on a single electrode unit, as taught by Devlin. This is because Devlin teaches a single electrode unit allows an easy to use and disposable unit to ensure proper placement (para. [0015-0016]).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Buckley et al. (US 9332918 B1), hereinafter referred to as Buckley, in view of Cho et al. (US 20050119711 A1), hereinafter referred to as Cho as applied to claim 1 above, and further in view of Wyeth et al. (US 20130190599 A1), hereinafter referred to as Wyeth.
Regarding claim 7, modified Buckley discloses the method of claim 1.
However, modified Buckley does not explicitly disclose wherein delivering the electrical stimulus comprises delivering, through a cable, the electrical stimulus from an output to a stimulating electrode (Fig. 7, col. 5, lines 22-57).
Wyeth teaches an analogous method for non-invasively monitoring changes of the body (Abstract, para. [0002]). Wyeth further teaches using a triaxially shielded cable (para. [0015], para. [0050]). 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 cable taught by modified Buckley to explicitly be a triaxially shielded cable, as taught by Wyeth. This is because Wyeth teaches a triaxially shielded cable increases isolation within the circuit, allowing for more accurate readings (para. [0050]).
Regarding claim 8, modified Buckley discloses the method of claim 1, wherein recording the resultant electrical waveform comprises receiving the resultant electrical waveform at a recording electrode and sending the resultant electrical waveform through a cable to an input (Fig. 7, col. 5, lines 22-57).
However, modified Buckley does not explicitly disclose a triaxially shielded cable.
Wyeth teaches an analogous method for non-invasively monitoring changes of the body (Abstract, para. [0002]). Wyeth further teaches using a triaxially shielded cable (para. [0015], para. [0050]). 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 cable taught by modified Buckley to explicitly be a triaxially shielded cable, as taught by Wyeth. This is because Wyeth teaches a triaxially shielded cable increases isolation within the circuit, allowing for more accurate readings (para. [0050]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Buckley et al. (US 9332918 B1), hereinafter referred to as Buckley, in view of Cho et al. (US 20050119711 A1), hereinafter referred to as Cho as applied to claim 1 above, and further in view of McGinnis et al. (US 20060276704 A1), hereinafter referred to as McGinnis.
Regarding claim 11, modified Buckley discloses the method of claim 1, wherein delivering the electrical stimulus comprises transmitting a plurality via a stimulating electrode positioned on skin of the body, the stimulating electrode in communication with an evoked potential detection device configured to monitor one or more peripheral nerves of the body (Fig. 7, col. 5, lines 22-57).
However, modified Buckley does not explicitly disclose time-locked electrical stimuli.
McGinnis teaches an analogous method for monitoring an evoked potential from a patient (Abstract, para. [0002-0003]). McGinnis further teaches utilizing time-locked electrical stimuli (para. [0038]). 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 taught by modified Buckley to explicitly utilize time-locked electrical stimuli, as taught by McGinnis. This is because McGinnis teaches time-locked stimuli allows for accurate determinations to be made regarding evoked potentials when stimulating and recording response across the entire body (para. [0038]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791