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 .
Election/Restrictions
Applicant's election with traverse of Group I (1-3, 6, 8-10, 12, 15, 17-18, 20-22, 25, 31-32, 36-37, 39, 41, 43-44, 70) in the reply filed on 7/2/2026 is acknowledged. The traversal is on the ground(s) that search would not be unduly burdensome. This is not found persuasive because MPEP 803 also recites a serious examination burden as proper for restrictions. Applicant has included four independent claims with various levels of overlap. Claim 46, and by extension claims 66-69, includes a pain classification model that is not present in the other independent claims which also requires a separate classification and field of search.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6, 8-10, 12, 15, 17-18, 20-22, 25, 31-32, 36-37, 39, 41, 43-44, 70 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.
Claims 1 & 31 recite the limitations "the epidural space" in line 2; “the spinal cord” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 43 recites the limitation "the algorithm’s control law.” There is insufficient antecedent basis for this limitation in the claim.
Claim 70 recites the limitations "the epidural space" in line 3; “the spinal cord” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-3, 6, 8-10, 12, 15, 17-18, 20-22, 25, 32, 36-37, 39, 41, 44 inherit the same deficiencies.
With respect to claims 1, 31, and 43, they recite “in a manner effective to treat the chronic pain” but it is unclear what is required for a treatment to be effective.
The term “effective/effectiveness” in claims 1, 25, 31, and 43 is a relative term which renders the claims indefinite. The term “effective/effectiveness” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what comprises effective/effectiveness, therefore it is unclear if electrical stimulation is effective to treat chronic pain.
Claims 2-3, 6, 8-10, 12, 15, 17-18, 20-22, 32, 36-37, 39, 41, 44 inherit the same deficiencies.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6, 8, 10, 12, 15, 17-18, 20-22, 25, 31-32, 36-37, 39, 41, 43-44, 70 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Annoni et al (US Pre Grant Publication 2020/0238087 A1).
Regarding claim 1, Annoni teaches a method for treating chronic pain in a subject, the method comprising:
positioning a first electrode at a location in the epidural space to deliver electrical stimulation to the spinal cord of the subject ([0068]; electrostimulator stimulates electrodes implanted at spinal nerve roots which are located in epidural space);
positioning a second electrode (503, Fig. 5) at a location in a frontal lobe region of the brain of the subject to detect a brain electrical signal associated with the chronic pain ([0098], Fig. 5 & 6; implantable lead-based electrodes 503 collect brain signals from frontal region to assess pain);
detecting the brain electrical signal at the frontal lobe region of the brain of the subject using the second electrode ([0098]; electrodes 503 collect brain signals from frontal region); and
applying electrical stimulation to the spinal cord using the first electrode in a manner effective to treat the chronic pain in the subject when the brain electrical signal detected using the second electrode exceeds a threshold level ([0103-0104]; when pain score exceeds threshold, SCS pain therapy delivers electrostimulation to spinal electrode).
Regarding claim 2, Annoni teaches the method of claim 1, further comprising using a control algorithm to automate said applying electrical stimulation when the brain electrical signal exceeds a threshold level ([0078]; programmer circuit 324 generates stimulation/electrode parameters for SCS based on pain score, [0104]; pain score exceeds threshold then first electrostimulation delivered).
Regarding claim 3, Annoni teaches the method of claim 2, wherein the control algorithm uses a machine learning algorithm for pain classification ([0063]; pain score generator 225 computes composite pain score using weighted averages, voting, decision trees, or neural networks).
Regarding claim 6, Annoni teaches the method of claim 2, wherein the control algorithm further modulates one or more programmed stimulation parameters based on a level of power of the brain electrical signal ([0061]; signal metrics generator 221 senses brain signals indicative of strength), wherein the control algorithm further determines the minimum stimulation amplitude needed to relieve the chronic pain based on a level of power of the brain electrical signal ([0076]; adaptive adjustment provides desired paresthesia coverage while minimizing patient discomfort and/or energy usage).
Regarding claim 8, Annoni teaches the method of claim 1, wherein said applying the electrical stimulation comprises applying the electrical stimulation to the spinal cord at the minimum stimulation amplitude needed to relieve the chronic pain ([0076]; adaptive adjustment provides desired paresthesia coverage while minimizing patient discomfort and/or energy usage; controller circuit 312 adjusts stimulation/electrode parameters for therapy).
Regarding claim 10, Annoni teaches the method of claim 1, wherein the frontal lobe region is a right frontal lobe region of the brain ([0098]; frontal lobe includes both regions in the left and right hemispheres).
Regarding claim 12, Annoni teaches the method of claim 1, wherein the brain electrical signal comprises alpha frequency, beta frequency, gamma frequency, delta frequency, or theta frequency neural oscillations ([0096]; delta wave extracted from sensed EEG).
Regarding claim 15, Annoni teaches the method of claim 1, wherein the second electrode is placed on a surface of a right frontal lobe region or within a right frontal lobe region ([0098]; frontal lobe includes both regions in the left and right hemispheres), wherein the second electrode is a non-brain penetratinq surface electrode array ([0071]; ECoG signals collected using electrode array positioned on cortical surface) or a brain-penetratinq electrode array.
Regarding claim 17, Annoni teaches the method of claim 1, further comprising positioning a third electrode (504, Fig. 5) at a location in a left frontal cortex region of the brain of the subject to detect a brain electrical signal ([0098]; one or more EEG electrodes collect signals from various brain regions including frontal lobe which includes left frontal cortex) associated with relief of the chronic pain.
Regarding claim 18, Annoni teaches the method of claim 17, wherein the third electrode is placed on a surface of the left frontal cortex region or within the left frontal cortex region ([0098]; one or more EEG electrodes collect signals from various brain regions including frontal lobe which includes left frontal cortex), wherein the third electrode is a non-brain penetratinq surface electrode array ([0071]; ECoG signals collected using electrode array positioned on cortical surface) or a brain- penetratinq electrode array.
Regarding claim 20, Annoni teaches the method of claim 1, further comprising using a control algorithm to automate adjustment of one or more programmed stimulation parameters to maintain the level of the brain electrical signal associated with relief of the chronic pain in a target range ([0104 0105], Fig. 6; step 610 senses functional signals in response to therapy at step 644; if functional signal improves pain score but falls within a specific range indicating no pain or mild pain, then therapy is not adjusted thereby maintaining functional signal indicating pain relief).
Regarding claim 21, Annoni teaches the method of claim 1, further comprising determining a paresthesia threshold for the electrical stimulation; and using a control algorithm to automate adjustment of one or more programmed stimulation parameters to apply the electrical stimulation at a level below the paresthesia threshold ([0076]; controller 312 adjusts stimulation/electrode parameters for sub-perception).
Regarding claims 22 & 41, Annoni teaches the method of claim 1 and the system of claim 31, wherein the chronic pain is caused by a pain-associated disorder, wherein applying the electrical stimulation relieves the pain ([0104]; pain-relief effect of delivered pain therapy assessed and adjusted to achieve desirable pain relief).
Regarding claim 25, Annoni teaches the method of claim 1, wherein the method further comprises:
assessing effectiveness of the treatment in the subject ([0071]; stimulation parameters automatically adjusted based on subjective description by patient);
mapping the brain of the subject to identify an optimal location in the right frontal lobe region to detect the brain electrical signal associated with the chronic pain ([0061]; magnetoencephalography (MEG) images entire brain and maps brain signals; signal metrics indicative of strength or pattern of brain activity associated with pain, identify the optimal locations in each region);
mapping the brain of the subject to identify an optimal location in the left frontal cortex region to detect the brain electrical signal associated with relief of the chronic pain ([0061]; signal metrics indicative of strength or pattern of brain activity associated with pain, identify the optimal locations in each region);
assessing relief of pain during or after treatment of the subject by using a visual analog scale or a verbal rating scale ([0071]; the patient-described pain quantification provided after stimulation suggests correlation to a verbal rating scale where specific ranges indicate no pain or mild pain; additional descriptors such as moderate and severe are necessary to assess pain) and/or
repositioning the first electrode in the epidural space to improve relief of pain.
Regarding claim 31, Annoni teaches a system for treating chronic pain in a subject, the system comprising:
a first electrode adapted for positioning at a location in the epidural space to deliver electrical stimulation to the spinal cord of a subject ([0068]; electrostimulator stimulates electrodes implanted at spinal nerve roots which are located in epidural space);
a second electrode (503, Fig. 5) adapted for positioning at a frontal lobe region of the brain of the subject and for detecting a brain electrical signal from the frontal lobe region of the brain of the subject ([0098], Fig. 5 & 6; implantable lead-based electrodes 503 collect brain signals from frontal region to assess pain); and
a processor (324, Fig. 3) programmed to instruct the first electrode to apply an electrical stimulation to the spinal cord ([0078]; programmer circuit 324 produces parameter values for IPG 310) in a manner effective to treat the chronic pain in the subject when a brain electrical signal that exceeds a threshold level is detected using the second electrode ([0104]; pain score exceeds threshold then first electrostimulation delivered).
Regarding claim 32, Annoni teaches the system of claim 31, wherein the frontal lobe region is a right frontal lobe region of the brain ([0098]; frontal lobe includes both regions in the left and right hemispheres).
Regarding claim 36, Annoni teaches the system of claim 31, wherein the second electrode is a non-brain penetrating surface electrode array ([0071]; ECoG signals collected using electrode array positioned on cortical surface) or a brain-penetrating electrode array.
Regarding claim 37, Annoni teaches the system of claim 31, further comprising a third electrode (504, Fig. 5) adapted for positioning at a location in a left frontal cortex region of the brain of the subject ([0098]; one or more EEG electrodes collect signals from various brain regions including frontal lobe which includes left frontal cortex), wherein the third electrode is a non-brain penetrating surface electrode array ([0071] ; ECoG signals collected using electrode array positioned on cortical surface) or a brain-penetrating electrode array.
Regarding claim 39, Annoni teaches the system of claim 31, wherein the system further comprises a user interface (240, Fig. 3) comprising an input electronically coupled to the processor for instructing the first electrode to apply an electrical stimulation ([0078]; programmer circuit 324 coupled to user interface 230 which allows operation of IPG 310) to the spinal cord to treat the chronic pain in the subject.
Regarding claim 43, Annoni teaches the system of claim 31, wherein the processor is further programmed to modulate one or more programmed stimulation parameters according to the algorithm's control law ([0078]; programmer circuit 324 generates stimulation/electrode parameters for SCS based on pain score); and apply the modulated electrical stimulation to the spinal cord using the first electrode (programmer circuit 324 provides adjusted stimulation/electrode parameters to IPG310) in a manner effective to treat the chronic pain.
Regarding claim 44, Annoni teaches the system of claim 31, wherein the processor is further programmed to set a maximum number of electrical stimulations per day and/or a total amount of time of electrical stimulation per day ([0076]; sub-perception stimulation may take over a day before patient can assess therapeutic effect; adaptive adjustment of therapy parameters based on sub-perception paresthesia necessitates setting a total amount of time of electrical stimulation per day).
Regarding claim 70, Annoni teaches a method of detecting whether a subject who has chronic pain is responding to spinal cord stimulation therapy, the method comprising:
positioning a first electrode at a location in the epidural space to deliver electrical stimulation to the spinal cord of the subject ([0068]; electrostimulator stimulates electrodes implanted at spinal nerve roots which are located in epidural space);
positioning a second electrode (503, Fig. 5) at a location in a frontal lobe region of the brain of the subject to detect a brain electrical signal associated with the chronic pain ([0098], Fig. 5 & 6; implantable lead-based electrodes 503 collect brain signals from frontal region to assess pain); and
detecting the brain electrical signal in the frontal lobe region of the brain of the subject using the second electrode before and after applying electrical stimulation to the spinal cord using the first electrode ([0103-0104]; SCS pain therapy delivered through spinal electrodes; closed-loop feedback with continuous adjustment monitors brain signals after SCS pain therapy), wherein a decrease in level of power of the brain electrical signal indicates the subject is responding to the spinal cord stimulation therapy and an increase or no change in the level of power of the brain electrical signal indicates the subject is not responding to the spinal cord stimulation therapy (examiner interprets this clause as an intended result of the claimed method and is necessarily met by performing the method).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Annoni et al (US Pre Grant Publication 2020/0238087 A1), in view of Yvert et al (International Publication EP 2394696 A1).
Regarding claim 9, Annoni teaches the method of claim 1, and further teaches comprising positioning a plurality of electrodes at the location in the frontal lobe region of the brain of the subject ([0098], Fig. 5 & 6; implantable lead-based electrodes 503 collect brain signals from frontal region) but does not disclose for detection of the brain electrical signal by stereoelectroencephalography (sEEG).
However, Yvert teaches a system and a method for applying and recording electrostimulation to living tissue and further teaches for detection of the brain electrical signal by stereoelectroencephalography (sEEG) ([0063]; SEEG using implanted electrodes).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method, as taught by Annoni, with detection of the brain electrical signal by stereoelectroencephalography (sEEG), as taught by Yvert. One of ordinary skill in the art would have been motivated to make these modifications to improve brain signal recordings by implanting brain electrodes to reduce signal noise (Yvert, [0063]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWANE COLLARD/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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