DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
This Office Action is responsive to the amendment filed 02/17/2026 (“Amendment”). Claims 1, 4-15, 18-21, and 23 are currently under consideration. The Office acknowledges the amendments to claims 1, 4, 18, and 20, as well as the cancellation of claim 16.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “detection module” in claims 1, 7, and 13-15, “processing module” in claims 1, 10, 19, and 23, “communication module” in claim 1, and “control module” in claims 10-12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 4-15, 18-21, and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1, 4-15, 18-21, and 23 are directed to a “system,” which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites (“sets forth” or “describes”) the abstract idea of a mental process, substantially as follows:
determine a stimulation threshold for a nerve of the patient from the first stimulus signal, the second stimulus signal, the first neuromuscular response, and the second neuromuscular response, wherein the stimulation threshold comprises at least a minimum pulse width required to elicit a neuromuscular response greater than or equal to a predetermined threshold, wherein the stimulation threshold is different from the first pulse width and the second pulse width, and wherein the processing module is configured to determine the stimulation threshold by applying an upper bound response threshold and a lower bound response threshold to determine whether the first neuromuscular response and/or the second neuromuscular response are artifacts or actual neuromuscular responses, and if the first neuromuscular response and/or the second neuromuscular response are actual neuromuscular responses, determine the stimulation threshold by comparing the first neuromuscular response and/or the second neuromuscular response to a dataset of neuromuscular responses versus stimuli.
The determining can be practically performed in the human mind, with the aid of a pen and paper, but for performance on a generic computer, in a computer environment, or merely using the computer as a tool to perform the steps. If a person were to see a printout of e.g. the neuromuscular responses and the dataset, they would be able to determine a stimulation threshold therefrom (by applying thresholds, comparing, etc.). There is nothing to suggest an undue level of complexity in the determinations. Therefore, a person would be able to perform the determinations mentally or with pen and paper.
Prong Two: Claim 1 does not include additional elements that integrate the mental process into a practical application. Therefore, the claims are “directed to” the mental process. 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. a processing module), and
add insignificant extra-solution activity (the pre-solution activity of: detecting neuromuscular responses, using generic data-gathering components (e.g. a detection module); and the post-solution activity of: communicating a color-coded indicator of the stimulation threshold, using generic data-outputting components (e.g. a communication module and a display)).
As a whole, the additional elements merely serve to gather and feed information to 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. No improvement to the technology is evident, and the indicator of the stimulation threshold is not outputted in any way such that a diagnostic benefit is realized, since e.g. no one needs to see, hear, or act on the indicator. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
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.
Dependent Claims
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 (e.g. thresholding and cross-correlating (claims 13-15), details of the dataset, comparison, and estimation (claims 21 and 23), etc.),
further describe the pre-solution activity (or the structure used for such activity) (e.g. the detection module comprising particular electrodes (claims 4-6), detection during pre-determined windows (7-9), controlling stimulus delivery (claims 10-12), etc.), and
further describe the post-solution activity (e.g. displaying various things using a display (claims 18-20), etc.).
Taken alone and 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 (e.g. as above, no one needs to see, hear, or act on the displayed indicators or information). They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology or technical field, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 10, 11, 18, 19, 21, and 23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over various teachings of US Patent Application Publication 2008/0058874 (“Westlund”) in view of US Patent Application Publication 2004/0158170 (“Overstreet”) and US Patent Application Publication 2005/0182454 (“Gharib”).
Regarding claim 1, Westlund teaches [a] neuromonitoring system (Abstract, detecting nerve injury), comprising: a detection module configured to detect, in muscle tissue of a patient, a first neuromuscular response in response to a first stimulus signal having a first pulse width and to detect a second neuromuscular response in response to a second stimulus signal having a second pulse width (Fig. 3, ¶ 0039, laryngeal activity input 325. Also see Fig. 9, ¶ 0051, describing the processing circuit 927 (equivalent to processing circuit 327 in Fig. 3) as including a stimulation threshold analyzer 962 that measures a stimulation threshold based on received signals indicative of laryngeal activity. A plurality of stimulation intensities (which result in a plurality of neuromuscular responses) are tested. Stimulation intensities are adjusted using different pulse widths), wherein the first stimulus signal and the second stimulus signal are delivered to the patient by an instrument (Fig. 1, lead 112, ¶¶ 0031 and 0032); a processing module in communication with the detection module and configured to determine a stimulation threshold for a nerve of the patient from the first stimulus signal, the second stimulus signal, the first neuromuscular response, and the second neuromuscular response, wherein the stimulation threshold comprises at least a minimum pulse width required to elicit a neuromuscular response greater than or equal to a predetermined threshold, wherein the stimulation threshold is different from the first pulse width and the second pulse width (Fig. 9, ¶ 0051, stimulation threshold analyzer 962, described above, determines the minimum stimulation intensity at which neural stimulation activates the vagus nerve or results in nerve capture (“exceeds the nerve capture threshold”)), and wherein the processing module is configured to determine the stimulation threshold by applying an upper bound response threshold and a lower bound response threshold to determine whether the first neuromuscular response and/or the second neuromuscular response are artifacts or actual neuromuscular responses (¶ 0050, filter 961 being a pass-band filter that filters out noise above and below the pass-band), …; and a display configured to receive and display [an] indicator (Fig. 10, screen 1077, ¶ 0057).
Westlund does not appear to explicitly teach a communication module in communication with the processing module and configured to communicate an indicator of the stimulation threshold to indicate nerve proximity (although in Fig. 10, user interface 1030 receives a signal from the processing circuit 927 and displays signals indicative of laryngeal activity and neural stimulation, as well as other various signals, messages, and/or indicators related to laryngeal activity, lead status, nerve injury, and/or other related information, including LED indicators based on thresholds - see ¶ 0057 and also see Fig. 11. Further, ¶ 0051 describes the stimulation threshold analyzer 962 as presenting a particular value as the stimulation threshold).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to present/output an indicator of the determined stimulation threshold in addition to the other indicators of Westlund, for the purpose of allowing a user to monitor the automatic process (¶¶s 0025, 0051, 0062, etc.), as well as for the purpose of making all information easily accessible (¶¶s 0057 and 0051).
Various teachings of Westlund do not appear to explicitly teach if the first neuromuscular response and/or the second neuromuscular response are actual neuromuscular responses, determine the stimulation threshold by comparing the first neuromuscular response and/or the second neuromuscular response to a dataset of neuromuscular responses versus stimuli.
Overstreet teaches comparing neuromuscular responses to a dataset of neuromuscular responses versus stimuli to determine a stimulation threshold (Fig. 2, ¶¶s 0032, 0034, 0035, etc., comparing to a growth curve).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a growth curve for determining stimulation threshold, as in Overstreet, for the purpose of overcoming effects of system noise (Overstreet: ¶ 0032).
Westlund-Overstreet does not appear to explicitly teach wherein the indicator comprises a visual gauge element having a color-coded visual region that varies in color as the stimulation threshold changes, such that a lower stimulation threshold is visually distinguished from a higher stimulation threshold to indicate said nerve proximity (although see gauge 1079 described with respect to Fig. 10 of Westlund).
Gharib teaches using a color-coded gauge display to indicate stimulation threshold and nerve proximity with different colors (Fig. 7, ¶ 0054).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a color-coded nerve proximity gauge in the combination as in Gharib, for the purpose of helping the user to more easily avoid contact with neural tissues (Gharib: ¶ 0054).
Regarding claim 4, Westlund-Overstreet-Gharib teaches all the features with respect to claim 1, as outlined above. Westlund-Overstreet-Gharib further teaches wherein the detection module comprises a sensing electrode configured to detect electromyography (EMG) signals (Gharib: claim 17. It would have been obvious to replace the sensor of the combination with EMG electrodes, as in Gharib, as the simple substitution of one muscle/nerve activation detector for another with predictable results (Gharib: Figs. 3 and 5, detecting nerve recruitment)).
Regarding claims 10 and 11, Westlund-Overstreet-Gharib teaches all the features with respect to claim 1, as outlined above. Westlund-Overstreet-Gharib further teaches wherein the processing module further comprises a control module configured to deliver a plurality of stimulus signals (based on the method of Westlund: Fig. 13 - also see ¶ 0062), wherein the plurality of stimulus signals comprises the first stimulus signal and the second stimulus signal and wherein each stimulus signal has a larger pulse width (Westlund: changing stimulation intensity by changing pulse width - ¶ 0051) than a preceding stimulus signal (Westlund: Fig. 13, step 1322), wherein the control module is further configured to increase a pulse width of each of the stimulus signals in the plurality of stimulus signals at a constant increment (Westlund: ¶¶s 0065 and 0066, with .DELTA.SI being about 0.2 V, it being obvious to use same increments for pulse widths like for amplitude to maintain the process of Fig. 13).
Regarding claims 18 and 19, Westlund-Overstreet-Gharib teaches all the features with respect to claim 1, as outlined above. Westlund-Overstreet-Gharib further teaches wherein the display is further configured to display a distance between the nerve and the surgical instrument, wherein the processing module is configured to determine the displayed distance from the stimulation threshold (Gharib teaches using stimulation threshold to determine nerve proximity, and also teaches displaying the distance to a user (¶ 0039, displaying nerve proximity, ¶ 0040 and Table 1, the minimum stimulation current threshold indicating distance). It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to calculate nerve proximity based on stimulation threshold, and to display distance, in the combination as in Gharib, for the purpose of ensuring the user does not get too close to the nerve (Gharib: ¶¶s 0039, 0040, Table 1, etc.).
Regarding claim 21, Westlund-Overstreet-Gharib teaches all the features with respect to claim 1, as outlined above. Westlund-Overstreet-Gharib further teaches wherein the dataset comprises a first range of stimulus levels that do not elicit any neuromuscular responses as stimulus levels increase, a second range of stimulus levels over which neuromuscular responses increase as stimulus levels increase, and a third range of stimulus levels over which EMG response levels plateau as stimulus levels increase (Gharib teaches a growth curve showing a non-stimulating range, a stimulating range, and a plateau range (Fig. 5, ¶ 0049, etc.). It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a dataset comprising the regions of Gharib in the combination, for the purpose of being able to visualize a full response profile (Gharib: Fig. 5), and for the purpose of better identifying nerve recruitment (Gharib: ¶ 0049, etc.)).
Regarding claim 23, Westlund-Overstreet-Gharib teaches all the features with respect to claim 1, as outlined above. Westlund-Overstreet-Gharib further teaches wherein the processing module is configured to compare the first neuromuscular response and/or the second neuromuscular response to the dataset of neuromuscular responses versus stimuli by determining where, within a graph indicative of the dataset, the first neuromuscular response, the second neuromuscular response, the first stimulus signal and the second stimulus signal lie and, based on positions of the first neuromuscular response, the second neuromuscular response, the first stimulus signal and the second stimulus signal in said graph, estimating the stimulation threshold required to produce a neuromuscular response at a specific point in the graph (Overstreet: Figs. 2, 3, ¶¶s 0032, 0034, 0035, etc.).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Westlund-Overstreet-Gharib in view of US Patent Application Publication 2005/0182456 (“Ziobro”).
Regarding claims 5 and 6, Westlund-Overstreet-Gharib teaches all the features with respect to claim 4, as outlined above. Westlund-Overstreet-Gharib further teaches wherein the sensing electrode comprises a surface EMG electrode, or wherein the sensing electrode comprises a needle EMG electrode.
Ziobro teaches an EMG system that uses needle-type or surface-type electrodes for detection (¶¶s 0044, 0069, etc.). The system is used for determining stimulation thresholds (claim 14).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use for the EMG electrodes of the combination needle- or surface-type electrodes as in Ziobro, since they are known alternatives for the purpose, and as the simple substitution of one known sensing component (the electrodes of Gharib) for another (those of Ziobro) with predictable results (gathering muscle activity data to determine stimulation thresholds - see Ziobro: claim 14).
Claims 7-9 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Westlund-Overstreet-Gharib in view of US Patent Application Publication 2011/0313483 (“Hincapie”).
Regarding claims 7-9, Westlund-Overstreet-Gharib teaches all the features with respect to claim 1, as outlined above. Westlund-Overstreet-Gharib does not appear to explicitly teach wherein the detection module is configured to detect the first and second neuromuscular responses in the muscle tissue during predetermined time windows, wherein the predetermined time windows are offset from delivery times of the first and second stimulus signals, wherein the predetermined time windows are offset based on a signal transit time associated with the nerve and the muscle tissue.
Hincapie teaches using a detection timer to time a detection window in response to delivery of a neurostimulation pulse (claim 1 - also see Figs. 6, 9, and 10 and ¶ 0060), the detection window offset from the delivery time by a particular amount which corresponds to transit time (Fig. 10 and related description - also see ¶ 0064, describing how the windows depend on the distance between the stimulation site and the sensing site).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use the detection window timing of Hincapie in the combination, for the purpose of improving detection of activation of different types of fibers (or for differentiating them) (Hincapie: ¶¶s 0059, 0060, etc.).
Regarding claims 13-15, Westlund-Overstreet-Gharib teaches all the features with respect to claim 1, as outlined above. Westlund-Overstreet-Gharib does not appear to explicitly teach wherein the detection module is further configured to apply a voltage level threshold to detected electromyography (EMG) signals, wherein the detection module is further configured to cross-correlate detected EMG signals with an EMG response template, wherein the detection module is further configured to apply a correlation level threshold to the cross-correlation.
Hincapie teaches applying a voltage threshold to detected EMG signals (¶ 0086, threshold amplitude, and Fig. 6, voltage on the y-axis). Hincapie also teaches cross-correlating an evoked muscular response with a stored baseline waveform/template and applying a correlation level threshold thereto (¶ 0086, threshold correlation).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use the thresholding and cross-correlation of Hincapie in the combination for the purpose of determining the stimulation threshold for one or more specific effects to thereby modulate a specific function (Hincapie: ¶ 0086).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Westlund-Overstreet-Gharib in view of US Patent Application Publication 2006/0025702 (“Sterrantino”).
Regarding claim 12, Westlund-Overstreet-Gharib teaches all the features with respect to claim 10, as outlined above. Westlund-Overstreet-Gharib does not appear to explicitly teach wherein the control module is further configured to increase a pulse width of each of the stimulus signals in the plurality of stimulus signals at varying increments.
Sterrantino teaches adjusting stimulation intensity in varying increments (¶ 0023, non-linear increments).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to increase the pulse width of the stimulus signal non-linearly, as in Sterrantino, for the purpose of more particularly tuning adjustments (Sterrantino: ¶ 0023), and as the simple substitution of one stimulation arrangement (that of Westlund) for another (that of Sterrantino) with predictable results (achieving a stimulation that results in nerve capture).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Westlund-Overstreet-Gharib in view of US Patent Application Publication 2012/0065538 (“Friedman”).
Regarding claim 20, Westlund-Overstreet-Gharib teaches all the features with respect to claim 1, as outlined above. Westlund-Overstreet-Gharib does not appear to explicitly teach wherein the display is configured to display the minimum pulse width corresponding to the stimulation threshold, but does teach wherein the gauge element is in the form of a dial (Gharib: Fig. 7).
Friedman teaches using an LCD screen to display stimulation parameters such as pulse width during stimulation (¶¶s 0041, 0067, etc.).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to display the minimum pulse width in the combination, which is the pulse width associated with the stimulation threshold, since this is the effective pulse width, and for the purpose of providing feedback to the user (Friedman: ¶¶s 0041, 0067, etc. – also see Overstreet: ¶¶s 0013, 0058, etc.).
Response to Arguments
Applicant’s arguments filed 02/17/2026 have been fully considered.
In response to the arguments regarding the rejections under 35 USC 101, they are not persuasive. The user interface does not provide intraoperative, clinically actionable guidance at least because the display need not display the indicator (even if it is configured to). Further, even if the display does display the indicator, there is nothing requiring a user to see or act on the indicator.
The claims are unlike those in the cited Core Wireless Licensing or Data Engine Technologies cases because they do not e.g. improve speed of a user’s navigation through various views and windows (constituting an improvement in the functioning of computers), and do not allow a user to avoid the burdensome task of navigating through spreadsheets in separate windows. I.e., the present display does not improve the computer or computer technology itself. It merely outputs the result of the abstract idea.
As for the “detection module,” the Office has not claimed that it is part of the abstract idea/mental process. Instead, it is part of extra-solution data-gathering activity. The claims do not necessarily describe artifact discrimination, but even if they did, there is no reason to believe that artifact discrimination could not be performed mentally or as part of extra-solution activity.
Claims are not eligible every time they are tied to physiological sensing. In Thales, for example, the arrangement of sensors itself was unique. Here, the data-gathering arrangement is not unique. In fact, claim 1 does not even specify the type of sensor. As for communication and output of an indicator, this is part of extra-solution activity. The extra-solution activity does not confer eligibility because as noted above, nobody needs to see or act on the information provided. I.e., it is not a “dynamic, real-time visual tool that surgeons rely upon.” This is especially true since the display is not required to display the indicator.
The system is also not a particular machine, since as noted above, there is no detail as to e.g. the sensor. Further, both the sensor and display are only involved in extra-solution activity. The claims are not constrained to intraoperative nerve monitoring, as argued by Applicant, at least because the elements cited for this proposition are found in different claims, and because the claims simply do not require this context. Further, the gauge is still considered part of extra-solution activity, at least because there is nothing requiring a user to make a change based on what they observe on the gauge as feedback.
Regarding step 2B, the Office has not relied on characterizing the gauge as well-understood, routine, or conventional, and therefore does not need to provide evidence of this.
In essence, Applicant argues based on many non-claimed features. This argumentation is not persuasive.
Applicant’s amendments and arguments regarding the rejections under 35 USC 103 are persuasive to the extent that the previous combination did not explicitly teach a color-coded indicator. Therefore, a new grounds of rejection has been made in view of Gharib, and all claims remain rejected in light of the prior art.
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.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791