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 .
Response to Arguments
The specification objection to paragraph 0041 has been withdrawn and the 35 USC §112(b) indefiniteness rejection have been withdrawn. The claim objections have been withdrawn.
The specification objection regarding browser executable code is not withdrawn in that the code itself remains.
Applicant's arguments filed 1/21/2026, with respect to the 35 USC § 112 rejections, have been fully considered but they are not persuasive. The specific rejections are not addressed, applicant states (in the response filed on 1/21/2026) that the rejections are overcome based on the claim amendments. The amendments recite the following limitations;
analyzing one or more recorded signals;
identifying one or more features in the one or more recorded signals; and
identifying the electrophysiological state by comparing the identified features to a database comprising information related to signal features for each of a plurality of electrophysiological states,
These limitations do not rectify the issues regarding written description and enablement. In this invention according to the claim limitations the electrophysiological state is used as feedback. As discussed previously these limitations are interpreted to include computer hardware and software. With respect to the written description, as directed by the MPEP, the invention must be described in sufficient detail so that one of ordinary skill in the art can reasonably conclude that the inventors had possession of the
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invention at the time of filing. The closest thing to an algorithm is found in figure 7 which is included for illustration purposes. Paragraphs 0065-0077 used to describe the steps found in figure 7. In these paragraphs there is no disclosure as to how applicant intends to use the signals recorded/sensed/received in order to use these signals as feedback. The specification, specifically paragraphs 0065-0077 appear to rely on knowledge of “a person having ordinary skill in the art (see paragraph 0068). With respect to the written description requirement, it is not enough that one of ordinary skill in the art could write a computer program to do this analysis, this must be disclosed within the specification. It is required, by the written description requirement, that the inventors disclose how they intend to perform this function. There is no disclosure.
Regarding the enablement rejections, these are also not addressed in the response, and will be maintained with the addition of the newly added claim language.
Applicant’s arguments, see applicant’s response, filed 1/21/2026, with respect to the rejections of under Panken et al. US 2009/0082829 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Vallejo et al. US 2018/0185645.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See paragraph 0050; although the http:// was removed, the executable code has not been removed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 12 each recite the newly added claim limitations:
analyzing one or more recorded signals;
identifying one or more features in the one or more recorded signals; and
identifying the electrophysiological state by comparing the identified features to a database comprising information related to signal features for each of a plurality of electrophysiological states,
This language is directed towards computer implemented steps, often seen as an algorithm however can also be expressed in mathematical terms. These are generally steps and procedures. These steps are not described in the specification in any manner. There is no discussion as to how recorded signals are analyzed, there is no discussion as to how features of the signals are identified and there is no discussion as to how an electrophysiological state or states are identified to then compare features to a database. Claims 1 and 18 provide no indication as to what signals are being sensed and then analyzed other than that they originate from the brain. Therefore these could be frequency signals such as recorded in EcOG or they could be compound action potentials or they could be some signal not contemplated. It is not discussed in the specification as to which signals specifically are used to then analyze. There is no discussion as to how the unknown signals are analyzed, it is not discussed which features from the signals are used to identify an electrophysiological state. The electrophysiological states are claimed to be chronic pain, autonomic dysfunction, autonomic dysfunction with dominant components of cardiac arrhythmia or intermittent hypotension, postural instability, gait dysfunction, multiple system atrophy, shaking, tremors and paralysis. Therefore, a signal is received and analyzed, there is no disclosure as to what the signal specifically is. This unknown signal is then used to identify features, there is no disclosure as to which features are identified. Once features are identified these features then seem to determine an electrophysiological state which can include chronic pain, autonomic dysfunction, autonomic dysfunction with dominant components of cardiac arrhythmia or intermittent hypotension, postural instability, gait dysfunction, multiple system atrophy, shaking, tremors and paralysis. By means of example, if tremors are identified, there is no disclosure as to how applicant intends to analyze a signal in order to specifically identify tremors. The specification states that one of ordinary skill in the are would know how to do this, however these are complex signals, from biological origins and it is not common knowledge to know exactly which signal is analyzed in an exact manner to determine a complex physiological state. There is simply no disclosure.
Claims 7-11 and 18-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 7-11 and 18-22 recite;
Claim 7: The system of claim 1, wherein the electrophysiological state is selected from chronic pain, autonomic dysfunction, autonomic dysfunction with dominant components of cardiac arrhythmia or intermittent hypotension, postural instability, gait dysfunction, multiple system atrophy, shaking, tremors, and paralysis.
Claim 8: The system of claim 1, wherein the electrophysiological state is tremors, shaking, or paralysis, and the target stimulation site is the spinal cord.
Claim 9: The system of claim 1, wherein the electrophysiological state is pain, and the target stimulation site is a nervous tissue detecting pain.
Claim 10: The system of claim 9, wherein the electrophysiological state is pain at a level below a threshold of conscious awareness for the patient.
Claim 11: The system of claim 1, wherein the electrophysiological state is intention to move, unconscious postural control, or autonomic dysfunction and the target stimulation site is the spinal cord to trigger skeletal motor activity, postural control, or heart rate stability.
Claim 18: The method of claim 12, wherein the electrophysiological state is selected from chronic pain, autonomic dysfunction, autonomic dysfunction with dominant components of cardiac arrhythmia or intermittent hypotension, postural instability, gait dysfunction, multiple system atrophy, shaking, tremors, and paralysis.
Claim 19: The method of claim 12, wherein the electrophysiological state is tremors, shaking, or paralysis and the target stimulation site is the spinal cord.
Claim 20: The method of claim 12, wherein the electrophysiological state is pain, and the target stimulation site is a nervous tissue detecting pain.
Claim 21: The method of claim 20, wherein the electrophysiological state is pain at a level below a threshold of conscious awareness for the patient.
Claim 22: The method of claim 12, wherein the electrophysiological state is intention to move, unconscious postural control, or autonomic dysfunction and the target stimulation site is the spinal cord to trigger skeletal motor activity, postural control, or heart rate stability.
Each of the claims are directed towards the electrophysiological state which is specific to the brain as directed by the independent claims. The electrophysiological state is used as feedback in the independent claims (claim 1, lines 23-27 and claim 12 lines 13-17). The use of sensed signals to be utilized as feedback for neural stimulation inherently and necessarily requires the use of software and/or an algorithm. Therefore these claims are considered fall within the classification of computer programming and or computer implemented inventions (MPEP 2161.01). With computer implemented inventions the written description must describe the claimed invention in sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventors has possession of the claimed invention at the time of filing. In this case the software and/or algorithm and/or steps and procedures for performing this computer function are not explained in sufficient detail to understand how the inventors intend the function to be performed. By way of explanation, if the physiological state is chosen to be chronic pain, then based on the independent claims from which these claims depend, the processor must be running software to deliver stimulation based on feedback. Stated another way, the processor must first identify pain from the ECG signal then use this identified pain to alter stimulation. This is in no way disclosed other than a discussion at a high level. The signal analysis to identify pain, autonomic dysfunction, autonomic dysfunction with dominant components of cardiac arrythmia or intermittent hypotension etc. is not disclosed. Nor is it disclosed how this signal analysis would then map to signal parameters delivered for spinal cord stimulation . It is not enough that one of skill in the art could write this software, the MPEP requires that the software and hardware combination is disclosed in order to comply with the written description requirement. If not hardware in combination with the software (including algorithms) are disclosed then the disclosure fails to provide adequate written description and undue experimentation is required.
Claims 1 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. When evaluating claim language for enablement the Wands Factors are analyzed, this analysis is found below.
Breadth
The language in question is directed towards the signal analysis “analyzing one or more recorded signals. The claim does not disclose what signals are analyzed other than the origin of the signals is the brain. Further, there it is unclear how these signals are analyzed. Is this a frequency analysis, an amplitude analysis or some other type of analysis. Further, it is unclear which features are extracted and how those features would lead to the identification on an electrorheological state. This would necessarily include any and all signals originating from the brain, analyzed in any manner. This leads to an extensive breadth.
Nature of the invention
The nature of the intention is complex; signal analysis of brain signals is by nature complex.
State of the prior art
The state of the prior art is developing.
Level of skill of one or ordinary skill in the art
The level of one of ordinary skill is high, PhD level.
Level of predictability in the art
The level of predictability is low.
Amount of direction provided by the inventors and Existence of working examples
There is no direction provided by the inventors as to how any of the states are determined from the signals recorded. Further there are no working examples provided.
Therefore it is determined that undue experimentation is necessary to implement the invention as claimed in claims 1 and 12.
Claims 7-11 and 18-22 are also rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. When evaluating claim language for enablement the Wands Factors are analyzed, this analysis is found below.
Breadth
The language in question is directed towards the electrophysiological state. In this language the electrophysiological state is used to selectively deliver stimulation signals to the spinal cord based on the electrophysiological state recorded by electrodes in the brain. These electrophysiological states include; chronic pain, autonomic dysfunction, autonomic dysfunction with dominant components of cardiac arrhythmia, intermittent hypotension, postural instability, gait dysfunction, multiple system atrophy, shaking, tremors, and paralysis, tremors, shaking, paralysis, intention to move, unconscious postural control, autonomic dysfunction, postural control, or heart rate stability. In this case the signals recorded from the brain tissue, likely EEG or EcOG, are sensed and analyzed in order to determine the different states. Therefore any signal analysis technique is claimed in this language and the breadth is expansive.
Nature of the invention
The nature of the intention is complex.
State of the prior art
The state of the prior art is developing.
Level of skill of one or ordinary skill in the art
The level of one of ordinary skill is high, PhD level.
Level of predictability in the art
The level of predictability is low.
Amount of direction provided by the inventors and Existence of working examples
There is no direction provided by the inventors as to how any of the states are determined from the signals recorded. Further there are no working examples provided.
Therefore it is determined that undue experimentation is necessary to implement the invention as claimed in claims 7-11 and 18-22.
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.
Claims 1, 4, 5, 7-12, 15, 16 and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Panken et al. US 2009/0082829 herein Panken and previously recited in view of the journal article to Escabí et al. titled A high-density, high-channel count, multiplexed ΜECOG array for auditory-cortex recordings iherein Escabì and previously recited and further in view of Vallejo et al. US 2018/0185645.
Regarding claims 1, 4-5, 7, 9, 12, 15-16, 18 and 20: Panken discloses a spinal cord stimulation system (figures 2A and 2B) comprising:
a recording array 44 (“surface electrode array”, paragraph 0088) with a plurality of electrodes (paragraph 0079) inserted to a target site of a brain 16 (figures 2A and 2B) to record ECG (“detect an ECG”, paragraph 0079)
a stimulation array with electrodes (figures 2A/2B and paragraphs 0080-81) inserted to a target stimulation site adjacent to the nervous tissue of the spinal cord (paragraphs 0079-81) to stimulate the spinal cord (“spinal cord stimulation” (SCS)”) paragraph 0079);
an inertia sensor (“accelerometer”, paragraphs 0046 and 0158 it is established in the art that an accelerometer is a type of inertia sensorii), the accelerometer detects finger taps which is broadly considered to be detecting a movement state of the patient;
a processor 60 (figure 4); and
non-transitory computer-readable medium storing instructions (considered to be the memory of the IMD which stores instructions, paragraphs 0059) which cause the processor 60 (figure 4) to:
receive recorded brain signals from the recording array (paragraph 0079);
determine an electrophysiological state of pain/chronic pain (“pain”, paragraph 0081, “chronic pain”, paragraph 0109) of the brain based on the signals received from the recording array (“pain” paragraph 00841-82);
receive inertia signals from the inertia sensor and determine a movement state of the patient (paragraph 0046); and
selectively deliver electrical stimulation via the stimulation array to the spinal cord based on the electrophysiological state of pain, the stimulation delivered from the spinal cord array stimulates the spinal cord (paragraphs 0082-85). The language “selectively deliver, via the at least one stimulation array, electrical stimulation to the target stimulation site based on one or more of the determined physiological state and the determined at least one of an orientation and a movement state of the patient” is considered to be a Markush grouping.
Panken further discloses analyzing the signals (abstract, paragraphs 0007, 0113,0116 and 0118); identifying features in the recorded signals and identifying the electrophysiological state by comparing the features to a threshold (paragraphs 0116, 0123, 0162, 0196, 0197, 0221, 0227 and 0256).
However, Panken does not disclose that the electrode arrays including about 100 electrodes with an electrode density of about 100 electrodes/cm2, electrode spacing of less than about 1mm and each electrode is less than about 1mm in diameter. Escabì however teaches of a high-density, high-channel count µECoG which includes 196 electrodes with a surface density of 1600 electrodes/cm2 (page 1566, column 1). The spacing between sites is 50µm and the electrodes are 200x200µm (page 1568, column 1 final paragraph). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Panken to include a high-density, high-channel count µECoG which includes 196 electrodes with a surface density of 1600 electrodes/cm2 , electrode spacing between sites of 50µm and the electrodes are 200x200µm, as taught by Escabì, in order to monitor and map the cortex without the use of penetrating electrodes (Escabì, page 1566 column 2).
Panken/ Escabì does not disclose the use of a database. Vallejo however teaches of comparing signals to a control signal obtained from a database (paragraph 0012). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Panken/ Escabì to include the use of a database, as taught by Vallejo, in order to utilize multiple patients in the signal analysis (paragraph 0049).
Regarding claims 8 and 19: Panken discloses that the biosignal detected is that of tremor (paragraphs 0003, 0044 and 0050).
Regarding claims 10 and 21: Panken discloses that the patient can alter the stimulation parameters at any time to treat pain, therefore the patient could change or alter stimulation when pain is below a threshold of awareness (paragraphs 0045, 0051 and 0109). Further Panken discloses that biosignal thresholds are stored in memory (paragraphs 0115-0116, 0129, 0159-160).
Regarding claims 11 and 22: Panken discloses that the intention to move (“thought”, paragraph 0083) is used.
Claims 2-3 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Panken et al. US 2009/0082829 herein Panken in view of the journal article to Escabí et al. titled A high-density, high-channel count, multiplexed ΜECOG array for auditory-cortex recordings iiiherein Escabì and further in view of Vallejo et al. US 2018/0185645 and further in view of Rapoport et al. US 2021/0213279 herein Rapoport and previously recited.
Regarding claims 2-3 and 13-14: Panken/Escabì/Vallejo discloses the claimed invention however Panken/Escabì/Vallejo does not mention the arrays being thin-film as well as 2-dimensional. Rapoport however teaches of a one, two or three dimensional electrode array (paragraph 0054, figures 4A-4D) which are thin-film electrode arrays (paragraphs 0147 and 0150). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Panken/Escabì/Vallejo to include two-dimensional thin-film arrays, as taught by Rapoport, in order to record or stimulate from the brain (Rapoport, paragraph 0055).
Claims 6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Panken et al. US 2009/0082829 herein Panken in view of the journal article to Escabí et al. titled A high-density, high-channel count, multiplexed ΜECOG array for auditory-cortex recordings ivherein Escabì and further in view of Vallejo et al. US 2018/0185645 and further in view of Chang et al. US 2022/0301563 herein Chang and previously recited.
Regarding claims 6 and 17: Panken/Escabì/Vallejo discloses the claimed invention. Escabì further teaches of a high-density, high channel count electrode array which could include designs which can be scaled to cover larger areas (page 1567, column 2). This indicates more electrodes however, Panken/Escabì/Vallejo does not specifically disclose at least 1024 electrodes in the array. Chang however teaches of an electrode array which includes 3-1024 electrodes (paragraph 0078). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Panken/Escabì/Vallejo to include at least 1024 electrodes, as taught by Chang, in order to record from larger tissue sites as discussed by Escabì.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
i Escabí, M. A., Read, H. L., Viventi, J., Kim, D.-H., Higgins, N. C., Storace, D. A., Liu, A. S., Gifford, A. M., Burke, J. F., Campisi, M., Kim, Y.-S., Avrin, A. E., Spiegel Jan, V. der, Huang, Y., Li, M., Wu, J., Rogers, J. A., Litt, B., & Cohen, Y. E. (2014). A high-density, high-channel count, multiplexed ΜECOG array for auditory-cortex recordings. Journal of Neurophysiology, 112(6), 1566–1583
ii https://www.vectornav.com/resources/inertial-navigation-primer/theory-of-operation/theory-inertial
iii Escabí, M. A., Read, H. L., Viventi, J., Kim, D.-H., Higgins, N. C., Storace, D. A., Liu, A. S., Gifford, A. M., Burke, J. F., Campisi, M., Kim, Y.-S., Avrin, A. E., Spiegel Jan, V. der, Huang, Y., Li, M., Wu, J., Rogers, J. A., Litt, B., & Cohen, Y. E. (2014). A high-density, high-channel count, multiplexed ΜECOG array for auditory-cortex recordings. Journal of Neurophysiology, 112(6), 1566–1583
iv Escabí, M. A., Read, H. L., Viventi, J., Kim, D.-H., Higgins, N. C., Storace, D. A., Liu, A. S., Gifford, A. M., Burke, J. F., Campisi, M., Kim, Y.-S., Avrin, A. E., Spiegel Jan, V. der, Huang, Y., Li, M., Wu, J., Rogers, J. A., Litt, B., & Cohen, Y. E. (2014). A high-density, high-channel count, multiplexed ΜECOG array for auditory-cortex recordings. Journal of Neurophysiology, 112(6), 1566–1583