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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/10/26 has been entered.
Notice of Amendment
In response to the amendment(s) filed on 2/10/26, amended claim(s) 1 and 12 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
Claim(s) 1-10 and 12-20 is/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.
For claim 1, the claim language “a first stimulation electrode” (line 5) and “a first stimulation electrode” (line 15) is ambiguous. It is unclear whether the same stimulation electrode is being referred to or whether these are different stimulation electrodes. The claim is examined under the former interpretation.
For claim 1, the claim language “a second stimulation electrode” (line 7) and “a second stimulation electrode” (line 20) is ambiguous. It is unclear whether the same stimulation electrode is being referred to or whether these are different stimulation electrodes. The claim is examined under the former interpretation.
Dependent claim(s) 2-10 and 12-20 fail to cure the ambiguity of independent claim 1, thus claims 1-10 and 12-20 is/are rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-10 and 12-20 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “instructions which … result in the operations comprising: facilitating a motor evoked potential (MEP) stimulation sequence to obtain an MEP, the facilitating comprising delivering, via a first stimulation electrode, a first stimulation pulse to one or more peripheral or cranial nerves of a patient, the one or more peripheral or cranial nerves located within a region of interest; delivering, after the facilitating and via a second stimulation electrode, the MEP stimulation sequence to one or more areas of the patient’s scalp or cranium to obtain an MEP response, the MEP stimulation sequence comprising a train of stimulation pulses; determining, based on the MEP response, whether a physiological response has occurred; and indicating, via the display operatively coupled to the first stimulation electrode and the second stimulation electrode, that the physiological response has occurred; wherein the facilitating is configured to one or more of: optimizing an intensity or pulse duration or number of pulses of the train stimulation pulses of the MEP stimulation sequence, limiting movement of the patient to the region of interest during the delivery of the MEP stimulation sequence, and improving accuracy of determining whether the physiological response has occurred; and wherein the facilitating is automatically initiated by the response identification device in response to one or more inputs from an SSEP monitoring system, an EMG monitoring system indicating a detected change exceeding a threshold, a heart rate monitoring system, a blood pressure monitoring system, or other patient monitoring system, and wherein the SSEP monitoring system uses the same first stimulation electrode for SSEP stimulation used for the facilitating.” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). This is mainly because this claim language is all “instructions” that cause results to occur and the claim is not claiming the actual structures or the actual manipulations. The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “a response identification device comprising at least one processor and at least one memory,” “a first stimulation electrode for coupling to a region of interest of a patient and to stimulate one or more peripheral or cranial nerves with in the region of interest,” “a second stimulation electrode for coupling to a scalp or cranium of the patient,” and “a display operatively coupled to the response identification device, the first stimulation electrode, and the second stimulation electrode.” However, these elements are not “significantly more” because they are well-known, routine, and/or conventional. Alice and Bilski are evidence that the response identification syste, processor, memory, and display are not significantly more because those cases held that generic computer structures, like processors, memories, and displays do not otherwise transform a patent ineligible claim into an eligible one. Para [0051] of U.S. Patent Application Publication No. 2012/0109257 to Yoo et al. (hereinafter “Yoo”) is evidence that a first stimulation electrode for coupling to a region of interest of a patient and to stimulate one or mor peripheral or cranial nerves with in the region of interest and a second stimulation electrode for coupling to a scalp or cranium of the patient is not significantly more because this manner is conventional. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fail to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 2-10, 12-18 and 20 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Dependent claim 19 does not recite significantly more because a “stimulation electrode” and a “recording electrode” are well-known, routine, and conventional as evidenced by para [0188]-[0189] of U.S. Patent Application Publication No. 2020/0023189 to Gribetz et al. (hereinafter “Gribetz”). Thus, claim(s) 1-10 and 12-20 is/are rejected under 35 U.S.C. 101.
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.
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.
Claim(s) 1-10 and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Intraoperative motor evoked potential monitoring – A position statement by the American Society of Neurophysiological Monitoring,” by MacDonald et al. (hereinafter “MacDonald”) in view of U.S. Patent Application Publication No. 2017/0303811 to Gharib et al. (hereinafter “Gharib”) and U.S. Patent Application Publication No. 2019/0321640 to Carmena et al. (hereinafter “Carmena”).
For claim 1, MacDonald discloses a stimulation system for detecting and identifying a patient physiological response (Abstract) (also see “2. Rationale and clinical basis for MEP monitoring”), the stimulation system comprising:
structure that results in operations (all structures under section “4. Methodology”) comprising:
facilitating a motor evoked potential (MEP) stimulation sequence to obtain an MEP, the facilitating comprising delivering, a first stimulation pulse to one or more peripheral or cranial nerves of a patient (section “3.2.1 Spinal cord stimulation” and “4.7 Facilitation”), the one or more peripheral or cranial nerves located within a region of interest (section “3.2.1 Spinal cord stimulation” and “4.7 Facilitation”), the first stimulation electrode configured to be coupled to the patient in the region of interest (section “3.2.1 Spinal cord stimulation” and “4.7 Facilitation”);
delivering, after the facilitating (see section “4.7 Facilitation,” which teaches double train facilitation with segmented and lateralized peripheral nerve stimulation to the MEP stimulation to “focally enhance MEPs,”), the MEP stimulation sequence to one or more areas of the patient to obtain an MEP response, the MEP stimulation sequence comprising a train of stimulation pulses (section “4.6 Pulse train parameters”), the second stimulation electrode configured to be coupled to a scalp of the patient (section “3.2.2 Brain Stimulation” and “4.2.1 TES electrode arrays”);
determining, based on the MEP response, whether a physiological response has occurred (sections “8.1 Classifying results” and “8.3 Outcome correlations”); and
wherein the facilitating is configured to one or more of: optimize an intensity or pulse duration or number of pulses of the train of stimulation pulses of the MEP stimulation sequence, limit movement of the patient to the region of interest during the delivery of the MEP stimulation, and improve an accuracy of determining whether the physiological response has occurred (sections “9.1 Cofounding factors,” “9.2 D-wave interpretation,” “9.3 Muscle MEP interpretation,” and/or “9.4 Monitoring situations”).
MacDonald does not expressly disclose that the structure is a response identification device comprising at least one processor and at least one memory; wherein the at least one memory storing instructions which, when executed by the at least one processor of the response identification device, cause the response identification device to perform operations.
However, Gharib teaches a response identification device comprising at least one processor (“control unit,” para [0011]) and at least one memory; wherein the at least one memory storing instructions which, when executed by the at least one processor of the response identification device, cause the response identification device to perform operations (“The control unit has at least one of computer programmed software, firmware and hardware capable of delivering a stimulation signal, receiving and processing neuromuscular or other bioelectric responses due to the stimulation signal, and identifying a relationship between the neuromuscular response and the stimulation signal,” para [0011]).
It would have been obvious to a skilled artisan to modify MacDonald such that the structure is a response identification device comprising at least one processor and at least one memory; wherein the at least one memory storing instructions which, when executed by the at least one processor of the response identification device, cause the response identification device to perform operations, in view of the teachings of Gharib, because a processor and memory are suitable structure for executing the results disclosed in MacDonald.
MacDonald does not expressly disclose a first stimulation electrode for coupling to a region of interest of a patient and to stimulate one or more peripheral or cranial nerves within the region of interest, that stimulation to the peripheral or cranial nerves is done with a first electrode; and a second stimulation electrode for coupling to a scalp or cranium of the patient, that the stimulation to the scalp is done with a second electrode.
However, Gharib teaches a first stimulation electrode for coupling to a region of interest of a patient and to stimulate one or more peripheral or cranial nerves within the region of interest, that stimulation to the peripheral or cranial nerves is done with a first electrode (see “PNS Electrodes” in Fig. 2) (also see para [0061] and [0071]) and a second stimulation electrode for coupling to a scalp or cranium of the patient, that the stimulation to the scalp is done with a second electrode (see “MEP Stimulator” in Fig. 2) (also see para [0061] and [0071]).
It would have been obvious to a skilled artisan to modify MacDonald to include a first stimulation electrode for coupling to a region of interest of a patient and to stimulate one or more peripheral or cranial nerves within the region of interest, that stimulation to the peripheral or cranial nerves is done with a first electrode; and a second stimulation electrode for coupling to a scalp or cranium of the patient, that the stimulation to the scalp is done with a second electrode, in view of the teachings of Gharib, because using two different electrodes is a suitable way to administer to two stimulations.
MacDonald does not expressly disclose a display operatively coupled to the response identification device, the first stimulation electrode, and the second stimulation electrode; and indicating, via the display operatively coupled to the first stimulation electrode and the second stimulation electrode, that the physiological response has occurred.
However, Gharib teaches a display operatively coupled to the response identification device, the first stimulation electrode, and the second stimulation electrode; and indicating, via the display operatively coupled to the first stimulation electrode and the second stimulation electrode, that the physiological response has occurred (para [0101] and [0105]).
It would have been obvious to a skilled artisan to modify MacDonald to include a display operatively coupled to the response identification device, the first stimulation electrode, and the second stimulation electrode; and indicating, via the display operatively coupled to the first stimulation electrode and the second stimulation electrode, that the physiological response has occurred, in view of the teachings of Gharib, for the obvious advantage of indicating to a surgeon whether a danger has occurred or is occurring (see para [0101] and [0105] of Gharib).
MacDonald and Gharib do not expressly disclose wherein the facilitating is automatically initiated by the response identification device in response to one or more inputs from an SSEP monitoring system, an EMG monitoring system indicating a detected change exceeding a threshold, a heart rate monitoring system, a blood pressure monitoring system, or other patient monitoring system, wherein the SSEP monitoring system uses the same first stimulation electrode for SSEP stimulation used for facilitating.
However, Carmena teaches wherein the facilitating is automatically initiated by the response identification device in response to one or more inputs from an SSEP monitoring system, an EMG monitoring system indicating a detected change exceeding a threshold, a heart rate monitoring system, a blood pressure monitoring system, or other patient monitoring system, wherein the SSEP monitoring system uses the same first stimulation electrode for SSEP stimulation used for facilitating (para [0023]).
It would have been obvious to a skilled artisan to modify MacDonald wherein the facilitating is automatically initiated by the response identification device in response to one or more inputs from an SSEP monitoring system, an EMG monitoring system indicating a detected change exceeding a threshold, a heart rate monitoring system, a blood pressure monitoring system, or other patient monitoring system, wherein the SSEP monitoring system uses the same first stimulation electrode for SSEP stimulation used for facilitating, in view of the teachings of Carmena, for the obvious advantage of beginning monitoring when a physiological parameter indicates that the patient is at risk of a condition, thereby making the stimulation personalized to the patient (see, for reference, para [0104] of Carmena).
For claim 2, MacDonald further discloses wherein the first stimulation pulse comprises a single stimulation pulse (Examiner’s Note: the term “comprises” being open claim language) (section “4.6 Pulse train parameters”).
For claim 3, MacDonald does not expressly disclose wherein delivering the first stimulation pulse to the one or more peripheral nerves of the patient is configured be delivered by an independent stimulator or one used for SSEP stimulation.
However, Gharib teaches wherein delivering the first stimulation pulse to the one or more peripheral nerves of the patient is configured be delivered by an independent stimulator or one used for SSEP stimulation (para [0107]).
It would have been obvious to a skilled artisan to modify MacDonald wherein delivering the first stimulation pulse to the one or more peripheral nerves of the patient is configured be delivered by an independent stimulator or one used for SSEP stimulation, in view of the teachings of Gharib, for the obvious advantage of determining if sensory nerves are transmitting information to the brain of the patient.
For claim 4, MacDonald further discloses wherein the operations further comprise delivering, prior to, during or after the facilitating and via the second stimulation electrode, a second MEP stimulation sequence to the one or more areas of the scalp or cranium of the patient, the second MEP stimulation sequence comprising a second train of stimulation pulses (section “4.6 Pulse train parameters”) (also see section “4.7 Facilitation”).
For claim 5, MacDonald further discloses wherein the second MEP stimulation sequence is delivered prior to the MEP stimulation sequence by an inter-train time interval (section “4.6 Pulse train parameters”) (also see section “4.7 Facilitation”); and wherein the facilitating occurs prior, during, or after the inter-train time interval (section “4.6 Pulse train parameters”) (also see section “4.7 Facilitation”).
For claim 6, MacDonald further discloses wherein the operations further comprise delivering the MEP stimulation sequence within a period of time after the facilitation of the MEP stimulation sequence (section “4.6 Pulse train parameters”) (also see section “4.7 Facilitation”).
For claim 7, MacDonald further discloses wherein the period of time is a predetermined period of time (section “4.6 Pulse train parameters”) (also see section “4.7 Facilitation”).
For claim 8, MacDonald does not expressly disclose wherein the period of time is dynamically adjusted based on one or more parameters of the patient and/or a type of surgery being performed on the patient.
However, Gharib teaches wherein the period of time is dynamically adjusted based on one or more parameters of the patient and/or a type of surgery being performed on the patient (para [0098]) (also see para [0072], which demonstrates that time is one of the signal parameters).
It would have been obvious to a skilled artisan to modify MacDonald wherein the period of time is dynamically adjusted based on one or more parameters of the patient and/or a type of surgery being performed on the patient, in view of the teachings of Gharib, for the obvious advantage of optimizing the stimulation signal parameters (see para [0098] of Gharib).
For claim 9, MacDonald further discloses wherein the facilitating occurs automatically within the period of time prior to delivering the MEP stimulation sequence (section “4.6 Pulse train parameters”) (also see section “4.7 Facilitation”).
For claim 10, MacDonald does not expressly disclose wherein the facilitating is manually initiated prior to delivering the MEP stimulation sequence.
However, Gharib teaches wherein the facilitating is manually initiated prior to delivering the MEP stimulation sequence (para [0098]) (also see para [0100]).
It would have been obvious to a skilled artisan to modify MacDonald wherein the facilitating is manually initiated prior to delivering the MEP stimulation sequence, in view of the teachings of Gharib, for the obvious advantage of giving control to the operator so that the stimulation may be optimized by a human being.
For claim 12, MacDonald and Gharib do not expressly disclose wherein one or more of the SSEP monitoring system, the EMG monitoring system, the heart rate monitoring system, the blood pressure monitoring system, and the other patient monitoring system is contained within or is a part of the stimulation system herein claimed.
However, Carmena teaches wherein one or more of the SSEP monitoring system, the EMG monitoring system, the heart rate monitoring system, the blood pressure monitoring system, and the other patient monitoring system is contained within or is a part of the stimulation system herein claimed (para [0157] and [0174]).
It would have been obvious to a skilled artisan to modify MacDonald wherein one or more of the SSEP monitoring system, the EMG monitoring system, the heart rate monitoring system, the blood pressure monitoring system, and the other patient monitoring system is contained within or is a part of the stimulation system herein claimed, in view of the teachings of Carmena, for the obvious advantage of beginning monitoring when a physiological parameter indicates that the patient is at risk of a condition, thereby making the stimulation personalized to the patient (see, for reference, para [0104] of Carmena).
For claim 13, MacDonald further discloses wherein the MEP comprises one or more waveforms (Fig. 1).
For claim 14, MacDonald does not expressly disclose wherein the processor stores the MEP as a baseline waveform.
However, Gharib teaches wherein the processor stores the MEP as a baseline waveform (Fig. 24 and/or 28-30) (para [0101]-[0102], [0106], and/or [0108]).
It would have been obvious to a skilled artisan to modify MacDonald wherein the processor stores the MEP as a baseline waveform, in view of the teachings of Gharib, to establish a user’s physiological response that can then be compared to later.
For claim 15, MacDonald does not expressly disclose wherein the determining comprises comparing the one or more waveforms of the MEP to the baseline waveform.
However, Gharib teaches wherein the determining comprises comparing the one or more waveforms of the MEP to the baseline waveform (Fig. 24 and/or 28-30) (para [0101]-[0102], [0106], and/or [0108]).
It would have been obvious to a skilled artisan to modify MacDonald wherein the determining comprises comparing the one or more waveforms of the MEP to the baseline waveform, in view of the teachings of Gharib, for the obvious advantage of avoiding neurological impairment (see para [0101] of Gharib).
For claim 16, MacDonald does not expressly disclose wherein the determining whether the physiological response has occurred comprises: comparing one or more features of the MEP to a threshold; and/or detecting a presence of the physiological response when the one or more features is greater than or equal to the threshold.
However, Gharib teaches wherein the determining whether the physiological response has occurred comprises: comparing one or more features of the MEP to a threshold (para [0101]); and/or detecting a presence of the physiological response when the one or more features is greater than or equal to the threshold (para [0101], “red”).
It would have been obvious to a skilled artisan to modify MacDonald wherein the determining whether the physiological response has occurred comprises: comparing one or more features of the MEP to a threshold; and/or detecting a presence of the physiological response when the one or more features is greater than or equal to the threshold, in view of the teachings of Gharib, for the obvious advantage of avoiding neurological impairment (see para [0101] of Gharib).
For claim 17, MacDonald does not expressly disclose wherein the determining whether the physiological response has occurred comprises: comparing one or more features of the MEP to a threshold; and/or detecting a presence of the physiological response when the one or more features is less than or equal to the threshold.
However, Gharib teaches wherein the determining whether the physiological response has occurred comprises: comparing one or more features of the MEP to a threshold (para [0101]); and/or detecting a presence of the physiological response when the one or more features is less than or equal to the threshold (para [0101], “green”).
It would have been obvious to a skilled artisan to modify MacDonald wherein the determining whether the physiological response has occurred comprises: comparing one or more features of the MEP to a threshold; and/or detecting a presence of the physiological response when the one or more features is less than or equal to the threshold, in view of the teachings of Gharib, for the obvious advantage of avoiding neurological impairment (see para [0101] of Gharib).
For claim 18, MacDonald does not expressly disclose a somatosensory evoked potential (SSEP) stimulation/acquisition system configured to use the same facilitation electrode or electrodes as the MEP stimulation sequence, the SSEP stimulation/acquisition system configured to acquire one or more SSEPs during or prior to delivery of the first stimulation pulse; and an MEP acquisition system configured to deliver the MEP stimulation sequence.
However, Gharib teaches a somatosensory evoked potential (SSEP) stimulation/acquisition system (Fig. 31) (para [0109]) configured to use the same facilitation electrode or electrodes as the MEP stimulation sequence (Figs. 23-24 and 26-27), the SSEP stimulation/acquisition system configured to (Examiner’s Note: functional language, i.e., capable of) acquire one or more SSEPs during or prior to delivery of the first stimulation pulse (para [0109]) (also see para [0062] and [0064]); and an MEP acquisition system configured to deliver the MEP stimulation sequence (Figs. 23-24 and 26-27).
It would have been obvious to a skilled artisan to modify MacDonald to include a somatosensory evoked potential (SSEP) stimulation/acquisition system configured to use the same facilitation electrode or electrodes as the MEP stimulation sequence, the SSEP stimulation/acquisition system configured to acquire one or more SSEPs during or prior to delivery of the first stimulation pulse; and an MEP acquisition system configured to deliver the MEP stimulation sequence, in view of the teachings of Gharib, for the obvious advantage of determining if sensory nerves are transmitting information to the brain of the patient.
For claim 19, MacDonald further discloses the stimulation electrode (section “4.1 Stimulating electrodes”); and a recording electrode (section “4.8 D-wave recording”).
For claim 20, MacDonald further discloses wherein the second stimulation electrode comprises four or more electrodes (section “4.2.1 TES electrode arrays”).
Response to Arguments
Applicant’s arguments filed 2/10/26 have been fully considered.
With respect to the 112 rejection(s), Applicant’s amendments and arguments are persuasive and thus the rejections are withdrawn. However, new 112 rejections have been necessitated in view of the amendments to the claims.
With respect to the 101 rejections, Applicant’s arguments will be treated in the order they were presented. With respect to the first argument, the claim still recites all of these steps as instructions, not actual steps of a method. And that makes sense because claim 1 is an apparatus-type claim, not a method claim. If claim 1 was a method claim and it was actually claiming stimulating a patient cranial nerve, then the actual step of performing that stimulation, via an electrode, would not be an abstract idea. But putting instructions on a memory that, when executed by a processor, cause the processor to facilitate the delivery of stimulation via an electrode is still just instructions. The claim doesn’t actually actively recite stimulating a person’s brain, but instead just the instructions to do so. This is evidenced by “at least one memory storing instructions which, when executed by the at least one processor, result in operations…,” as recited in claim 1. That is, all of the claimed subject matter is instructions, not the actual result itself. The instructions will just lead to results. For example, an instruction to “facilitate[e] a motor evoked potential (MEP) stimulation sequence” is not the same as reciting an active method step of “delivering a first stimulation pulse to one or more peripheral or cranial nerves of a patient with a first stimulation electrode.” The additional arguments of improvements in the technology are unsubstantiated as Applicant has provided no evidence to support this contention. We are instructed that "attorney's arguments .. cannot take the place of evidence." In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (citation omitted); see also In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (holding that lawyer arguments and conclusory statements that are unsupported by factual evidence are entitled to little probative value). The alleged improvement of “MEP reliability” is an improvement of the instructions on the computer, and improving instructions is just improving information.
With respect to the 103 rejections, Applicant’s arguments will be treated in the order they presented in the response. With respect to the first argument, it’s unclear whether this argument is actually commensurate in scope with the claim language and/or addressing the rejection of record. For example, MacDonald is not relied upon for teaching the claimed “first electrode” or “second electrode,” so arguing that MacDonald doesn’t teach “shared electrodes” (1) doesn’t seem to be in the claim language (since there is no term “shared electrode”); and (2) doesn’t seem to acknowledge that the rejection states that MacDoanld doesn’t teach the claimed “first electrode” or “second electrode.” With respect to the second argument, this argument also seems to suffer from the same condition that it doesn’t address the rejection of record. Gharib is not relied upon for teaching “wherein the facilitating is automatically initiated by the response identification device in response to one or more inputs from an SSEP monitoring system, an EMG monitoring system indicating a detected change exceeding a threshold, a heart rate monitoring system, a blood pressure monitoring system, or other patient monitoring system, wherein the SSEP monitoring system uses the same first stimulation electrode for SSEP stimulation used for facilitating,” Carmena is. With respect to the third argument, Carmena is relied upon for teaching automatic initiation and coordination with other patient monitoring systems in the rejection. Additionally, Carmena is not relied upon for teaching transcranial MEP stimulation in the rejection, so this argument is moot too. Moreover, claim 1 recites “an SSEP monitoring system, an EMG monitoring system indicating a detected change exceeding a threshold, a heart rate monitoring system, a blood pressure monitoring system, or other patient monitoring system, wherein the SSEP monitoring system uses the same first stimulation electrode for SSEP stimulation used for facilitating” (emphasis added). That is, these systems are recited in the alternative, such that the claim does not require every single system recited to be anticipated. With respect to the non-analogous art argument, all the references are in the field of nerve stimulation devices and the claimed subject matter is also nerve stimulation devices. Alternatively, Carmena is reasonably pertinent to problem of having to automate stimulation because for personnel to do the stimulation is costly and requires availability/pre-booking (see para [0003] of Applicant’s specification as originally filed). Carmena is reasonably pertinent to that cost/scheduling problem because it automates stimulation, which would then eliminate and/or obviate the need for specialized personnel. With respect to the fourth argument, the examiner respectfully submits that a skilled artisan would be motivated “for the obvious advantage of beginning monitoring when a physiological parameter indicates that the patient is at risk of a condition, thereby making the stimulation personalized to the patient,” as established in the above rejection. Applicant is reminded that, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). So it’s not that the skilled artisan would be forced into taking every single part of every single reference to arrive at some hybrid system, but instead the inquiry is what a skilled artisan would reasonable modify when considering each document. For example, the argument concerning the different powering methods is a red herring because the rejection doesn’t rely on any of the powering methods of Gharib of Carmena to arrive at the obviousness conclusion. So taking those powering system would be a bodily incorporation since the rejection doesn’t rely on them when making a modification.
Conclusion
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
Prosecution Insights