DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
The Claims are objected to because of the following informalities:
In Claim 1, the term “stimulating with one or more pulses a thoracic spinal region of a back of the patient” should be replaced with -- stimulating, with one or more pulses, a thoracic spinal region of a back of the patient -- for grammatical clarity.
Appropriate correction is required and applicant should carefully review the Claims for any other informalities.
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 12 and claims dependent thereon 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 pre-AIA the applicant regards as the invention.
Claim 12 recites the limitation "the pair of anodal electrodes." There is insufficient antecedent basis for this limitation in the claim. Examiner suggest amending the claim to read “12. The method of claim 1, wherein the pair of anodal electrodes are positioned over both temporal bones of a cranium of the patient.”
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 18 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.
Regarding Claim 18, the claim(s) recites “determining, by a computing device in communication with the at least one recording electrode, an inadequacy of one or more resulting muscle response electrical waveforms from the one or more muscles of the one or more lower extremities of the patient;” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“stimulating with one or more pulses a thoracic spinal region of a back of the patient using at least one cathodal electrode positioned thereon and at least one anodal electrode positioned over at least one anterior superior iliac crest area of the patient, where the one or more pulses has a duration of at least 500 µs;”
“detecting, with at least one recording electrode on at least one leg of the patient, one or more resulting muscle response electrical waveforms from one or more muscles of one or more lower extremities of the patient.”
“stimulating the one or more lower extremities of the patient using one or more peripheral electrodes in response to the determination.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity. As written, there same stimulation can be given in response to the determination of inadequacy of the one or more resulting muscle responses, regardless of what the determination is.
Furthermore, stimulating electrodes and recording electrodes are general field of use and computing devices are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of determining an inadequacy in a muscle response electrical waveform detected at the at least recording electrode due to the applied stimulation on the patient and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
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.
Claim(s) 1, 3-4, 13-15, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hacker et al (US 2005/0085743) (“Hacker”) in view of Edgerton et al (US 2016/0121109) (“Edgerton”).
Regarding Claim 1, while Hacker teaches a method of monitoring reflexive motor responses in a patient during a surgery on the patient (Abstract, [0017], [0026], [0071], [0075]-[0077], [0079], [0081]-[0086], [0093], [0097], [0114]-[0116]), the method comprising:
stimulating with one or more pulses a thoracic spinal region of a back of the patient using at least one electrode positioned thereon and at least one anodal electrode positioned over the patient, where the one or more pulses has a duration of at least 500 µs ([0114]-[0116] stimulating with one or more pulses a spinal region of a back of the patient using at least one cathode electrode positioned thereon and at least one anodal electrode positioned over at least a second region of the patient, [0075]-[0077], [0081]-[0085] using a bipolar stimulation with one electrode as a cathode and one electrode as an anode, where the pulses may have a duration A of 500 µs, Fig. 23, [0075], [0081] with the cathode electrode placed on the spine and the anode electrode potentially placed at the spine or the a hip region, [0093] the spinal region being stimulated including a thoracic spinal region); and
detecting, with at least one recording electrode on at least one leg of the patient, one or more resulting muscle response electrical waveforms from one or more muscles of one or more lower extremities of the patient ([0114]-[0116] detecting with at least one recording electrode, one or more resulting muscle response electrical waveforms from one or more muscles of the patient through EMG, [0008] where the stimulation monitoring can involve either upper or lower extremities necessitating the presence of the EMG electrodes on these extremities),
Hacker fails to teach
stimulating with at least one anodal electrode positioned over at least one anterior superior iliac crest area of the patient.
However Edgerton teaches monitoring reflexive motor responses in a patient (Abstract, [0168]-[0175] transcutaneous stimulation in the spinal region was evaluated and reflexive motor responses are known to be identified), the monitoring comprising:
stimulating with one or more pulses a thoracic spinal region of a back of the patient ([0168]-[0172] involuntary step-like movement can be generated by pulses at a thoracic spinal region of a patient, Fig. 5B, [0085] where the stimulation is applied at thoracic spinal region of a back of the patient) using at least one cathodal electrode positioned thereon and at least one anodal electrode positioned over at least one anterior superior iliac crest area of the patient (Fig. 5A-6, [0085]-[0086], [0153] single active electrode / cathode electrode placed at back, two ground electrode / anode electrodes placed at anterior superior iliac crest as shown by the Figures), where the one or more pulses has a duration of at least 500 µs ([0182]); and
detecting, with at least one recording electrode on at least one leg of the patient, one or more resulting muscle response electrical waveforms from one or more muscles of one or more lower extremities of the patient ([0168]-[0175], [0182], Figs. 5A-6, where resulting EMG response electrical waveforms from muscles of one or more lower extremities of the patient are monitored during stimulation to identify activation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the intraoperative monitoring of Hacker with the specific teachings of Edgerton as a way to achieve a specific intraoperative monitoring outcome outlined broadly by Hacker. Specifically, the intraoperative procedure of Hacker can apply the relationship between a stimulated nerve root location of the T11-T12 vertebrae corresponds to lumbar vertebrae L2-L3 (Edgerton: [0170]) and muscle responses at a patient’s leg when performing a lumbar spine operation (Hacker: [0114]). When fully considered, Edgerton’s teachings can be applied in a similar manner as the intraoperative monitoring of Stone in view of Edgerton’s stimulation teachings enabling lumbar surgeries in the L2-L3 region. Thus, Edgerton’s stimulation of lower extremities through the thoracic spine location can reflect continued healthy nerve status by the resulting muscle response electrical waveforms – the desired monitoring in Hacker. Finally, it would be obvious to set the anode electrode location to be the anterior superior iliac crest as shown in Edgerton’s Fig. 6 as applying an anode electrode placement that has shown success at facilitating thoracic stimulation and lower limb monitoring.
Regarding Claim 3, Hacker and Edgerton teach the method of claim 1, wherein stimulating the at least one cathodal electrode comprises stimulating the at least one cathodal electrode subcutaneously (See Claim 1 Rejection, Hacker [0114] stimulation 2 has electrodes located within the anatomical tissue).
Regarding Claim 4, Hacker and Edgerton teach the method of claim 1, wherein the at least one cathodal electrode is located at or between the tenth, eleventh, or twelfth thoracic vertebrae of the patient (See Claim 1 Rejection, nerve root response stimulated at eleventh and twelfth vertebrae).
Regarding Claim 13, Hacker and Edgerton teach the method of claim 1, wherein the at least one anodal electrode comprises a pair of anodal electrodes positioned over both anterior superior iliac crest areas of the patient (See Claim 1 Rejection).
Regarding Claim 14, Hacker and Edgerton teach the method of claim 1, and Hacker teaches eliciting motor evoked potentials in a biphasic sequenced output allows “a more complete interpretation of neurological motor responses, and the inability to efficiently integrate multiple neural monitoring modalities.” (Hacker: [0016]), where biphasic stimulation is alternating stimulating between a cathodal electrode and an anodal electrode (Hacker: [0081]-[0082]) where the system includes one cathodal electrode, a pair of anodal electrodes, and biphasic stimulation (See Claim 1 Rejection), indicates the biphasic stimulation necessitates alternating stimulating with a first anodal electrode of a pair of anodal electrodes and a second anodal electrode of the pair of anodal electrodes as part of the alternating occurring between the electrodes.
Regarding Claim 15, Hacker and Edgerton teach the method of claim 1, wherein the at least one recording electrode is coupled to at least one muscle of the one or more lower extremities of the patient ([0073]-[0076] muscles monitored, [0094]-[0095] with example muscles given at lower extremities).
Regarding Claim 19, while Hacker teaches an apparatus for monitoring reflexive motor responses in a patient during a surgery on the patient (Abstract, [0017], [0026], [0071], [0075]-[0077], [0079], [0081]-[0086], [0093], [0097], [0114]-[0116]), the apparatus comprising:
at least one processor configured to execute the computer-executable instructions ([0087] central processing unit (CPU) 90) and cause the apparatus to:
stimulate a thoracic spinal region of a back of the patient with one or more pulses provided by at least one cathodal electrode positioned near the thoracic spinal region and at least one anodal electrode positioned over the patient, the one or more pulses having a duration of at least 500 µs ([0114]-[0116] stimulating with one or more pulses a spinal region of a back of the patient using at least one cathode electrode positioned thereon and at least one anodal electrode positioned over at least a second region of the patient, [0075]-[0077], [0081]-[0085] using a bipolar stimulation with one electrode as a cathode and one electrode as an anode, where the pulses may have a duration A of 500 µs, Fig. 23, [0075], [0081] with the cathode electrode placed on the spine and the anode electrode potentially placed at the spine or the hip region, [0093] the spinal region being stimulated including a thoracic spinal region); and
obtain, from at least one recording electrode on at least one leg of the patient, one or more resulting muscle response electrical waveforms from one or more muscles of one or more lower extremities of the patient ([0114]-[0116] detecting with at least one recording electrode, one or more resulting muscle response electrical waveforms from one or more muscles of the patient through EMG, [0008] where the stimulation monitoring can involve either upper or lower extremities necessitating the presence of the EMG electrodes on these extremities),
Hacker fails to teach stimulating a thoracic spinal region of a back of the patient with one or more pulses provided by at least one anodal electrode positioned over at least one anterior superior iliac crest area of the patient.
However Edgerton teaches monitoring reflexive motor responses in a patient (Abstract, [0168]-[0175] transcutaneous stimulation in the spinal region was evaluated and reflexive motor responses are known to be identified), the monitoring comprising:
a memory comprising computer-executable instructions and at least one processor to execute the computer-executable instructions ([0068]) and cause the apparatus to; and
stimulating with one or more pulses a thoracic spinal region of a back of the patient ([0168]-[0172] involuntary step-like movement can be generated by pulses at a thoracic spinal region of a patient, Fig. 5B, [0085] where the stimulation is applied at thoracic spinal region of a back of the patient) using at least one cathodal electrode positioned thereon and at least one anodal electrode positioned over at least one anterior superior iliac crest area of the patient (Fig. 5A-6, [0085]-[0086], [0153] single active electrode / cathode electrode placed at back, two ground electrode / anode electrodes placed at anterior superior iliac crest as shown by the Figures), where the one or more pulses has a duration of at least 500 µs ([0182]); and
detecting, with at least one recording electrode on at least one leg of the patient, one or more resulting muscle response electrical waveforms from one or more muscles of one or more lower extremities of the patient ([0168]-[0175], [0182], Figs. 5A-6, where resulting EMG response electrical waveforms from muscles of one or more lower extremities of the patient are monitored during stimulation to identify activation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the intraoperative monitoring of Hacker with the specific teachings of Edgerton as a way to achieve a specific intraoperative monitoring outcome outlined broadly by Hacker. Specifically, the intraoperative procedure of Hacker can apply the relationship between a stimulated nerve root location of the T11-T12 vertebrae corresponds to lumbar vertebrae L2-L3 (Edgerton: [0170]) and muscle responses at a patient’s leg when performing a lumbar spine operation (Hacker: [0114]). When fully considered, Edgerton’s teachings can be applied in a similar manner as the intraoperative monitoring of Stone in view of Edgerton’s stimulation teachings enabling lumbar surgeries in the L2-L3 region. Thus, Edgerton’s stimulation of lower extremities through the thoracic spine location can reflect continued healthy nerve status by the resulting muscle response electrical waveforms – the desired monitoring in Hacker. Further, it would be obvious to set the anode electrode location to be the anterior superior iliac crest as shown in Edgerton’s Fig. 6 as applying an anode electrode placement that has shown success at facilitating thoracic stimulation and lower limb monitoring. Finally, it would be obvious to include a memory device comprising computer-executable instructions as taught by Edgerton the application of a known technique for providing of processor instructions by a memory (Edgerton) to a known device applying instructions to a processor (Hacker) ready for improvement to yield predictable results of consistently automated intraoperative neuromodulation steps.
Regarding Claim 20, while Hacker teaches a system for monitoring reflexive motor responses in a patient during a surgery on the patient (Abstract, [0017], [0026], [0071], [0075]-[0077], [0079], [0081]-[0086], [0093], [0097], [0114]-[0116]), the system comprising:
one or more cathodal electrodes positioned over a thoracic spinal region of a back of the patient ([0114]-[0116] stimulating with one or more pulses a spinal region of a back of the patient using at least one cathode electrode positioned thereon and at least one anodal electrode positioned over at least a second region of the patient, [0075]-[0077], [0081]-[0085] using a bipolar stimulation with one electrode as a cathode and one electrode as an anode, where the pulses may have a duration A of 500 µs, Fig. 23, [0075], [0081] with the cathode electrode placed on the spine and the anode electrode potentially placed at the spine or the hip region, [0093] the spinal region being stimulated including a thoracic spinal region);
one or more anodal electrodes positioned over an area of the patient ([0075]-[0077], [0081]-[0085]);
one or more recording electrodes positioned on at least one leg of the patient ([0114]-[0116] detecting with at least one recording electrode, one or more resulting muscle response electrical waveforms from one or more muscles of the patient through EMG, [0008] where the stimulation monitoring can involve either upper or lower extremities necessitating the presence of the EMG electrodes on these extremities); and
a computing device ([0087] central processing unit (CPU) 90) configured to:
stimulate the thoracic spinal region with one or more pulses using at least one of the one or more cathodal electrodes with at least one of the one or more anodal electrodes, wherein the one or more pulses have a duration of at least 500 µs ([0075]-[0077], [0081]-[0085], [0114]-[0116]); and
obtain, from at least one of the one or more recording electrodes, one or more resulting muscle response electrical waveforms from one or more muscles of one or more lower extremities of the patient ([0114]-[0116]).
Hacker fails to teach
one or more anodal electrodes positioned over at least one anterior superior iliac crest area of the patient.
However Edgerton teaches monitoring reflexive motor responses in a patient (Abstract, [0168]-[0175] transcutaneous stimulation in the spinal region was evaluated and reflexive motor responses are known to be identified), the monitoring comprising:
stimulating with one or more pulses a thoracic spinal region of a back of the patient ([0168]-[0172] involuntary step-like movement can be generated by pulses at a thoracic spinal region of a patient, Fig. 5B, [0085] where the stimulation is applied at thoracic spinal region of a back of the patient) using at least one cathodal electrode positioned thereon and at least one anodal electrode positioned over at least one anterior superior iliac crest area of the patient (Fig. 5A-6, [0085]-[0086], [0153] single active electrode / cathode electrode placed at back, two ground electrode / anode electrodes placed at anterior superior iliac crest as shown by the Figures), where the one or more pulses has a duration of at least 500 µs ([0182]); and
detecting, with at least one recording electrode on at least one leg of the patient, one or more resulting muscle response electrical waveforms from one or more muscles of one or more lower extremities of the patient ([0168]-[0175], [0182], Figs. 5A-6, where resulting EMG response electrical waveforms from muscles of one or more lower extremities of the patient are monitored during stimulation to identify activation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the intraoperative monitoring of Hacker with the specific teachings of Edgerton as a way to achieve a specific intraoperative monitoring outcome outlined broadly by Hacker. Specifically, the intraoperative procedure of Hacker can apply the relationship between a stimulated nerve root location of the T11-T12 vertebrae corresponds to lumbar vertebrae L2-L3 (Edgerton: [0170]) and muscle responses at a patient’s leg when performing a lumbar spine operation (Hacker: [0114]). When fully considered, Edgerton’s teachings can be applied in a similar manner as the intraoperative monitoring of Stone in view of Edgerton’s stimulation teachings enabling lumbar surgeries in the L2-L3 region. Thus, Edgerton’s stimulation of lower extremities through the thoracic spine location can reflect continued healthy nerve status by the resulting muscle response electrical waveforms – the desired monitoring in Hacker. Finally, it would be obvious to set the anode electrode location to be the anterior superior iliac crest as shown in Edgerton’s Fig. 6 as applying an anode electrode placement that has shown success at facilitating thoracic stimulation and lower limb monitoring.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hacker in view of Edgerton and further in view of Block et al (US 2019/0239763) (“Block”).
Regarding Claim 2, while Hacker and Edgerton teach the method of claim 1, their combined efforts fail to teach wherein stimulating the at least one cathodal electrode comprises stimulating the at least one cathodal electrode cutaneously.
However Block teaches an evoked potential monitoring system (Abstract, [0043]) where the electrodes for stimulating may be placed on, over, or through the skin (Abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the subdermal electrodes of Hacker with cutaneous as taught by Block as Block teaches that electrodes may operate with the skin in multiple placement relationships (Abstract). Thus the placement is a simple substitution of one skin placement for a stimulating electrode (Hacker: within the skin) for another (Block: atop the skin) to obtain the predictable result of a reliably stimulated subject.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hacker in view of Edgerton and further in view of Lu et al (US 2021/0378991) (“Lu”) and further in view of Block.
Regarding Claim 5, while Hacker and Edgerton teach the method of claim 1, their combined efforts fail to teach the method further comprising a pair of cathodal electrodes located at the high thoracic or low cervical spinal region of the patient.
However Lu teaches a spinal cord stimulation system (Abstract) where upper extremity movement capability can be tested by pairs of cathodal electrodes at a low cervical spinal region ([0080-[0081] testing of motor control / hand function by stimulation at the cervical spine, [0072] with a 16 electrode array shown, [0090] where stimulation may be applied along the entirety of the cervical spine and a pair of these electrodes would be found at the low cervical spine region) where measurable force and electrical response was identifiable by electromyography (Fig. 2G and 2H, [0071], [0073]) and Block teaches a spinal stimulation system with components for measuring both upper extremities and lower extremities ([0029], [0036]-[0037]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to add cathode electrodes at the low cervical spine region with EMG monitoring on the upper extremities as taught by Lu for the system of Hacker as Block teaches that a single system can be configured for monitoring both locations ([0029], [0036]-[0037]). In setting up Hacker with this functionality, we increase its utility by enabling evaluation of lower AND upper limbs. Furthermore, it would be obvious to set a new pair of cathode electrodes specifically at the low cervical region as taught by Lu as the stimulation location causes responses in upper extremities in similar way to that of Edgerton. Thus, one would recognize that applying Lu’s stimulation of upper extremities through the cervical spine location can similarly reflect continued healthy nerve status by the resulting muscle response electrical waveforms – the desired monitoring in Hacker.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hacker in view of Edgerton and further in view of Lo et al (US 2022/0386935) (“Lo”).
Regarding Claim 6, while Hacker and Edgerton teach the method of claim 1, their combined efforts fail to teach wherein the at least one cathodal electrode comprises a first pair of cathodal electrodes located on opposite sides of the thoracic spinal region of the back of the patient.
However Lo teaches a spinal cord stimulation system (Abstract) which utilizes an electrode array with electrodes symmetrically placed on opposite sides of the spinal region of the back of the patient (Fig. 3, [0155]) where electrodes may be selectively used as cathodes/anodes ([0187]), and such an array can be used to find an optimal stimulating electrode in the chosen monitoring region ([0105]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to add potential cathode electrodes located on opposite side of the patient’s spine as taught in Lo to enable a large surface area of optimization for electrodes in Hacker.
Regarding Claim 7, while Hacker and Edgerton teach the method of claim 6, wherein the at least one cathodal electrode further comprises a second pair of cathodal electrodes located on opposite sides of the thoracic spinal region of the back of the patient above or below the first pair of cathodal electrodes (See Claim 6 Rejection, inherent to arrays shown in Figs. 8-11C).
Regarding Claim 8, while Hacker and Edgerton teach the method of claim 7, wherein the stimulating the at least one cathodal electrode comprises alternating between stimulating the first pair of cathodal electrodes and the second pair of cathodal electrodes (See Claim 7 Rejection, biphasic stimulation will have the alternating scheme and an optimization process will include multiple pairs of electrodes which all are potential cathode electrodes ).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hacker in view of Edgerton and further in view of Lu.
Regarding Claim 9, while Hacker and Edgerton teach the method of claim 1, and Hacker teaches determining, by a computing device in communication with the at least one recording electrode, the at least one desired spinal monitoring region of the back of the patient (Fig. 24, [0094]-[0095] gives recommendation on cathode electrode nerve root location based on pair muscles for monitoring), their combined efforts fail to teach the method further comprising: determining the at least one cathodal electrode to stimulate, from a plurality of cathodal electrodes over the thoracic spinal region of the back of the patient.
However Lu teaches an array of stimulating electrodes as part of a spinal cord stimulation system (Abstract, Fig. 2, [0079], [0090]) that enables optimal stimulation control ([0094]-[0096], [0109]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the optimization teachings specific to a desired muscle taught in Lu could be applied to Hacker in finding which electrodes of the array best correspond to the different montages.
Regarding Claim 10 Hacker, Edgerton, and Lu teach the method of claim 9, wherein determining the at least one cathodal electrode to stimulate comprises determining the at least one cathodal electrode to stimulate based on the one or more muscles to be monitored (See Claim 9 Rejection, Hacker: Fig. 24, [0094]-[0095] gives recommendation on cathode electrode nerve root location based on pair muscles for monitoring).
Claim(s) 11-12 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hacker in view of Edgerton and further in view of Ahmed (US 2014/0257016) (“Ahmed 016”).
Regarding Claim 11 while Hacker and Edgerton teach the method of claim 1, and Hacker teaches stimulating at a scalp ([0081]), their combined efforts fail to teach the method further comprising a pair of anodal electrodes positioned over a cranium of the patient.
However Ahmed 016 teaches a treatment of neuromotor dysfunction (Abstract) comprises a triple stimulation of the distal nerve, the spinal junction on the neural pathway of interest, and a location above the spinal junction on the neural pathway ([0013] triple stimulation is highly effective in mitigating dysfunction)t where a cervical spinal stimulation location can be paired with stimulation at a location above the spinal junction on the neural pathway positioned over a cranium of the patient ([0014])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to add a pair of anode electrodes at cranium of the patient as taught by Ahmed 016 for the intraoperative monitoring system of Hacker as Hacker teaches that the system is capable for monitoring at the cervical region as well ([0114]). Thus electrodes may be placed at the cranium to enable a triple stimulation scheme as taught by Ahmed 016 with the understanding that the biphasic stimulation of these electrodes may have the electrodes at the cranium acting as anodes. Adding this capability and electrodes to the system of Hacker and Edgerton expands the monitoring capabilities and thus the system’s diagnostic capability.
Regarding Claim 12 while Hacker and Edgerton teach the method of claim 1, and Hacker teaches stimulating at a scalp ([0081]), their combined efforts fail to teach the method further comprising wherein the pair of anodal electrodes are positioned over both temporal bones of a cranium of the patient.
However Ahmed 016 teaches a treatment of neuromotor dysfunction (Abstract) comprises a triple stimulation of the distal nerve, the spinal junction on the neural pathway of interest, and a location above the spinal junction on the neural pathway ([0013] triple stimulation is highly effective in mitigating dysfunction)t where a cervical spinal stimulation location can be paired with stimulation at a location above the spinal junction on the neural pathway positioned over a cranium of the patient ([0014] stimulation applied bilaterally and is thus positioned over both temporal bones).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to add a pair of anode electrodes at cranium of the patient as taught by Ahmed 016 for the intraoperative monitoring system of Hacker as Hacker teaches that the system is capable for monitoring at the cervical region as well ([0114]). Thus electrodes may be placed at the cranium to enable a triple stimulation scheme as taught by Ahmed 016 with the understanding that the biphasic stimulation of these electrodes may have the electrodes at the cranium acting as anodes. Adding this capability and electrodes to the system of Hacker and Edgerton expands the monitoring capabilities and thus the system’s diagnostic capability and may be seen as another option in the muscle montage of Hacker’s Fig. 24.
Regarding Claim 16 while Hacker and Edgerton teach the method of claim 1, their combined efforts fail to teach the method further comprising: prior to the stimulating the at least one cathodal electrode with the at least one anodal electrode, stimulating one or more lower extremities of the patient using one or more peripheral electrodes located on the one or more lower extremities.
However Ahmed 016 teaches a neuromotor evaluation system (Abstract) where an initial evoked response at a peripheral site will activate a somatosensory cortex and enhance the effect of subsequent stimulations ([0076]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide an initial stimulation with a system of Hacker and Edgerton at the peripheral site as Ahmed 016 teaches that an evoked response at the peripheral site can enhance the effect of subsequent stimulations ([0076]). Correspondingly, Hacker’s extremity monitoring from evoked responses in response to stimulations can be enhanced.
Regarding Claim 17, Hacker, Edgerton, and Ahmed 016 teach the method of claim 16, further comprising selecting the one or more peripheral electrodes to stimulate to enhance the one or more resulting muscle response electrical waveforms from the one or more muscles of the one or more lower extremities of the patient (See Claim 16 Rejection, Hacker with monitoring of lower extremities, Ahmed teaching the value of stimulation enhancing muscle response electrical waveforms).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hacker in view of Edgerton and further in view of Ahmed (US 2015/0196767) (“Ahmed 767”).
Regarding Claim 18 while Hacker and Edgerton teach the method of claim 1, and Hacker teaches the method further comprising:
determining, by a computing device in communication with the at least one recording electrode, an inadequacy of one or more resulting muscle response electrical waveforms from the one or more muscles of the one or more lower extremities of the patient (See Claim 1 Rejection, [0077], [0109] EMG activity recorded and a determination of nerve integrity is ascertained); their combined efforts fail to teach
stimulating the one or more lower extremities of the patient using one or more peripheral electrodes in response to the determination.
However Ahmed 767 teaches a neuromodulation control system where peripheral stimulation can be applied to treat limb conditions, supporting trans-spinal direct current stimulation for improving muscle tone ([0058], [0104]-[0105] peripheral nerve direct stimulation is applied).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the peripheral nerve stimulation of Ahmed 767 in response to nerve dysfunction identified by Hacker as this should be configurable in a way to improve nerve function (Ahmed 767: [0058]). Thus one of ordinary skill in the art would recognize that this would be an appropriate intervention in response to a nerve damaged during surgery.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights