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
In response to the Examiner’s Non-Final Rejection (filed 1/3/2025), the Applicant filed amendments and arguments on 4/2/2025. These have been carefully considered by the Examiner.
Amendments to the Drawings
The Applicant has provided replacement drawings to correct various informalities. These Replacement Drawings are accepted by the Examiner. Previous objections to drawings are withdrawn at this time.
Status of Claims
The Applicant notes the following changes to the status of the claims (Remarks, pg. 12):
Claim 6 is canceled without prejudice or disclaimer.
Claims 1, 7, and 19 are amended.
Claim 21 is added.
The examiner accepts these changes and has considered them in further examination of the application.
Objections to Drawings
The Applicant has provided an amended Specification to correct various informalities regarding drawing objections. These Replacement Drawings are accepted by the Examiner. Previous objections to drawings are withdrawn at this time.
Objections to the Specification
The Applicant has provided an amended Specification to correct various informalities. The disclosure was objected to because of the following informalities:
“IMD” is shown in Fig. 10 but never defined in the specification.
In [0023], "flor" presumably should be "flow".
“Eigensystem realization algorithm” or “ERA” is not being specifically defined. Please define in “background of invention” if it is a well-known algorithm.
Changes regarding “IMD” and the typographical error (“flor” instead of “flow”), the changes to the Specification are accepted and those objections are withdrawn.
The Applicant traverses the objection of further defining the “ERA”. (Remarks, pg. 13) However, the Examiner maintains the objection to “Eigensystem realization algorithm” or “ERA” not being specifically defined. The Specification is unclear without this being defined more in-depth. Appropriate correction is required.
Claim Rejections – 35 U.S.C. 102
Claims 1-7, 9, and 19 were rejected by the Examiner under 35 U.S.C. 102(a)(1) as being anticipated by John (US 2006/0217781). The Applicant has chosen to cancel claim 6 and traverse the rejections to the remaining claims.
Applicant’s arguments, see Applicant Arguments/Remarks (pg. 14), filed 4/2/2025, with respect to the rejections of claims 1-7, 9, and 19 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. Please see further examination of the amended claims below.
Claim Rejections – 35 U.S.C. 103
Claims 8, 10-18, and 20 were rejected by the Examiner under 35 U.S.C. 103 as being unpatentable over John in view of Moffitt. The Applicant states John and Moffitt, individually or in combination, fail to disclose at least one element of claim 1, and therefore those claims depending from claim 1, and has traversed the rejection.
Applicant’s arguments, see Applicant Arguments/Remarks (pg. 15), filed 4/2/2025, with respect to the rejection of claims 8, 10-18, and 20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. Please see further examination of the amended claims below.
The Office's Reliance on Official Notice or Personal Knowledge is Improper
The Applicant argues that the Office makes several assertions that are unsupported by any evidence provided by the Office (Remarks, pg. 15-16). The Applicant specifically points to claims 8, 13-18, and 20. In order to alleviate this, the claims have been reexamined with the new amendments taken into consideration.
Claims 8 and 13-18 have been explained in further detail with differing prior art citations from the original document. The rationale of claim 20 has been maintained, as the Examiner states the limitations of “pulse amplitude and electrode polarity parameters” are further supported by “…any other stimulation characteristic that determines the treatment stimulation.” ([0134] of John). Please see further examination of the amended claims below.
Double Patenting Rejections
Claims 1-20 were provisionally rejected on the ground of non-statutory double patenting over claims 1-20 of copending U.S. Pat. App. No. 17/968,739. The Applicant has requested that the Office hold the remaining non-statutory double patenting rejections in abeyance until all claims are indicated as being allowable. (Remarks, pg. 16) The Examiner notes that this double patenting rejection is held in abeyance until prosecution of both cases is completed.
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.
Claims 1-5, 7, 9, and 13-21 are rejected under 35 U.S.C. 103 as being unpatentable over John (US 2006/0217781) (cited previously) in view of De Ridder (US 8682441).
Regarding amended, independent claim 1, John discloses methods and systems for treatment of brain disorders using neuromodulation that is provided to modulate structures of brain networks. John goes on to disclose a method of providing a neurostimulation therapy to a patient ([0049]: “Neurostimulation may be either excitatory or inhibitory stimulation, and may be at least electrical, magnetic, optical or chemical, or a combination of two or more of these.”), comprising:
applying electrical pulses to a neural target of a patient ([0050]: “As used herein, the term “stimulation subsystem” refers to all components that permit the [brain modulation system] to actively alter (‘modulate’) neural tissue during neuromodulation treatment, and may include at least one pulse generator…”);
obtaining electroencephalogram (EEG) data corresponding to a neurological response of the patient to the electrical pulses ([0081]: “…functional imaging data may used to identify and evaluate the brain networks of a patient before and during treatment.”; [0041]: “…functional neuroimaging can include techniques such as electroencephalography (EEG)…”);
processing the EEG data to form EEG localization data reflecting neural activity at cortical locations of the patient ([0082]: “Rather than occurring within the [brain neuromodulation device (BND)] itself, under the direction of a physician, abnormal activity in dispersed portions of a network may be measured in a number of manners, for example, by superposition of three dimensional source localization of the generators of quantitative EEG (QEEG) measurements.”);
forming, using the EEG localization data, a multi-dimensional representation of a state of the patient ([0082]: “…abnormal activity in dispersed portions of a network may be measured …by superposition of three dimensional source localization of the generators of quantitative EEG (QEEG) measurements.”);
comparing the multi-dimensional representation of a state of the patient to one or more multi-dimensional representations of a state of healthy controls ([0089]: “With respect to evaluating treatment of the brain networks 108, evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”);
adjusting one or more stimulation parameters based on the comparing (“Evaluate treatment” 108 in Fig. 2A; [0078]: “…the effects of the treatment provided by the modulation of the brain network are evaluated 108…”); and
programming an implantable pulse generator of the patient to operate according to the one or more adjusted parameters ([0050]: “…may include at least one pulse generator…”) of the patient to operate according to the one or more adjusted parameters (“Modify treatment” 110 in Fig. 2A; [0078]: “…modulation parameters are adjusted 110…”).
John does not disclose selecting a predetermined number of features corresponding to activity within multiple respective frequency bands at a subset of the cortical locations of the patient.
However, De Ridder teaches a method of stimulating nerve tissue of a patient using a pulse generator. De Ridder further teaches selecting a predetermined number of features corresponding to activity within multiple respective frequency bands at a subset of the cortical locations of the patient ([col. 4, li. 29-36]: “…add an alpha frequency peak to stimulate primary and secondary cortical areas; add a beta frequency peak to stimulate association cortical areas, such as frontal cortex; add a theta frequency peak to stimulate the cingulate, hippocampus, amygdala; add a delta frequency peak to stimulate the brainstem, ventral tegmental area (VTA), nucleus accumbens/ventral medial prefrontal cortex (VMPFC).”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the multi-dimensional representation of a state of the patient of John with the features corresponding to activity within multiple respective frequency bands at a subset of the cortical locations of the patient shown by De Ridder in order to aid in source localization computations.
Regarding claim 2, in view of the John/De Ridder combination, John discloses that the comparing comprises: calculating a distance metric that measures a multi-dimensional distance between the multi-dimensional representation of the state of the patient to a multi- dimensional representation that is reflective of an average state from a population of health controls ([0089]: “With respect to evaluating treatment of the brain networks 108, evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”).
Regarding claim 3, in view of the John/De Ridder combination, John discloses providing output to a clinician reflecting a value of the calculated distance metric ([0089]: “Such change can be quantified by representing the patient's brain state as a multivariate vector (Brain State Vector, or BSV), in a multi-dimensional signal space and using the length of the BSV to quantify the distance from the normative region centered around the origin of the signal space.”).
Regarding claim 4, in view of the John/De Ridder combination, John discloses that the distance metric is a norm vector calculation ([0089]: “The [Brain State Vector] can be a vector computed as the difference between normative vector and an abnormal vector, or alternatively the BSV can be computed from z-scores and thus can be both statistically-based and normalized.”).
Regarding claim 5, in view of the John/De Ridder combination, John discloses automatically calculating one or more values for one or more stimulation parameters ([0091]: “The detection of network events can occur due to the evaluation of sensed data using treatment criteria and can occur automatically in the processor of the control subsystem of the [brain neuromodulation device].”) based on the distance metric ([0089]: “Such change can be quantified by representing the patient's brain state as a multivariate vector (Brain State Vector, or BSV), in a multi-dimensional signal space and using the length of the BSV to quantify the distance from the normative region centered around the origin of the signal space.”).
Regarding amended claim 7, in view of the John/De Ridder combination, John discloses conducting an analysis to determine a patient systemic response to neurostimulation that depends upon the distance metric ([0089]: “Effective treatments should shorten the [Brain State Vector, or BSV], incorrect treatment may lengthen the BSV, and “side effects” may cause a change or rotation in the direction of the BSV in the signal space. The BSV can be computed upon the components of network model… In other words, abnormal activity of the network is normalized or changed to bring an undesirable characteristic of the network closer to a desired level.”).
Regarding claim 9, in view of the John/De Ridder combination, John discloses defining a boundary between multi-dimensional representations of patients with a same or similar neurological condition as the patient and multi-dimensional representations of health controls ([0089]: “With respect to evaluating treatment of the brain networks 108, evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”).
Regarding claim 13, in view of the John/De Ridder combination, John discloses that the patient is a chronic pain patient ([0060]: “In the treatment of some types of pain, treatment can be provided to block ascending signals so that these do not reach the areas of the brain which are responsible for the subjective sensation of pain...”) and the multi- dimensional representation of a state of the patient comprises at least one patient feature corresponding to an insular cortex location ([0124]: “The stimulation can be applied, for example, to a network including one or more of the hippocampus, insula, right middle temporal gyrus, occipital cortex, temporal cortex, hypothalamus, anterior pituitary, posterior pituitary, and right posterior temporal lobe.”; Note that insula is a synonym for the insular cortex.).
Regarding claim 14, in view of the John/De Ridder combination, John discloses that the patient is a chronic pain patient ([0060]: “In the treatment of some types of pain, treatment can be provided to block ascending signals so that these do not reach the areas of the brain which are responsible for the subjective sensation of pain...”) and the multi- dimensional representation of a state of the patient comprises at least one patient feature.
John does not disclose a correspondence to a dorsolateral prefrontal cortex (DLPFC) location.
However, De Ridder teaches a correspondence to a dorsolateral prefrontal cortex (DLPFC) location ([col. 6, li. 10-15]: “…brain tissue also includes cortical targets, for example, auditory cortex, prefrontal cortex, the dorsolateral prefrontal cortex, the ventromedial prefrontal cortex, the cingulate cortex, subcallosal area, anterior cingulate cortex, the subgenual anterior cingulate cortex, the motor cortex and the somatosensory cortex.”). De Ridder further discusses a pain treatment context ([col. 16, li. 42-44]: “…the neuromodulation method described herein is utilized to treat a subject suffering from or suspected of suffering from pain.”)
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify John to include De Ridder’s utilizing of patient features corresponding to a DLPFC location in order to properly support patient pain management.
Regarding claim 15, in view of the John/De Ridder combination, John discloses that the patient is a chronic pain patient ([0060]: “In the treatment of some types of pain, treatment can be provided to block ascending signals so that these do not reach the areas of the brain which are responsible for the subjective sensation of pain...”) and the multi- dimensional representation of a state of the patient comprises at least one patient feature.
John does not disclose a correspondence to a medial prefrontal cortex location.
However, De Ridder teaches a correspondence to a medial prefrontal cortex location ([col. 6, li. 10-15]: “…brain tissue also includes cortical targets, for example, auditory cortex, prefrontal cortex, the dorsolateral prefrontal cortex, the ventromedial prefrontal cortex, the cingulate cortex, subcallosal area, anterior cingulate cortex, the subgenual anterior cingulate cortex, the motor cortex and the somatosensory cortex.”). De Ridder further discusses a pain treatment context ([col. 16, li. 42-44]: “…the neuromodulation method described herein is utilized to treat a subject suffering from or suspected of suffering from pain.”)
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify John to include De Ridder’s utilizing of patient features corresponding to a medial prefrontal cortex location in order to properly support patient pain management.
Regarding claim 16, in view of the John/De Ridder combination, John discloses that the multi-dimensional representation of a state of the patient ([0082]: “…abnormal activity in dispersed portions of a network may be measured in a number of manners, for example, by superposition of three-dimensional source localization of the generators of quantitative EEG (QEEG) measurements.”).
John does not disclose respective features corresponding to cortical activity at respective locations with low theta, high theta, alpha, beta, and gamma frequency bands.
However, De Ridder teaches respective features corresponding to cortical activity at respective locations with low theta, high theta, alpha, beta, and gamma frequency bands ([col. 4, li. 29-36]: “…add an alpha frequency peak to stimulate primary and secondary cortical areas; add a beta frequency peak to stimulate association cortical areas, such as frontal cortex; add a theta frequency peak to stimulate the cingulate, hippocampus, amygdala; add a delta frequency peak to stimulate the brainstem, ventral tegmental area (VTA), nucleus accumbens/ventral medial prefrontal cortex (VMPFC).”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the multi-dimensional representation of a state of the patient of John with the features corresponding to cortical activity at respective locations with low theta, high theta, alpha, beta, and gamma frequency bands shown by De Ridder in order to aid in source localization computations.
Regarding claim 17, in view of the John/De Ridder combination, John discloses establishing a communication connection between a patient device and a clinician device for a remote programming session ([0074]: “It should be noted that in conceivable circumstances, such as a multi-bed intensive care unit or coma ward, there might be a central station that remotely communicates with the processors of multiple BNDs which are treating multiple patients.”) to provide the neurostimulation therapy to the patient ([0142]: “The linked rules and the protocols can be contained within a database of the BND, can be adjusted by the medical personnel or patient using the external patient programmer.”).
Regarding claim 18, in view of the John/De Ridder combination, John discloses establishing a communication connection between a patient device and a clinician device for an in-person programming session to provide the neurostimulation therapy to the patient (([0074]: “It should be noted that in conceivable circumstances, such as a multi-bed intensive care unit or coma ward, there might be a central station that remotely communicates with the processors of multiple BNDs which are treating multiple patients.”; [0142]: “The linked rules and the protocols can be contained within a database of the BND, can be adjusted by the medical personnel or patient using the external patient programmer.”).
Regarding amended claim 19, in view of the John/De Ridder combination, John discloses conducting an automatic adjustment of stimulation parameters across respective parameter ranges for neurostimulation of the patient while repetitively performing the forming the multi- dimensional representation of a state of the patient and comparing the multi-dimensional representation of a state of the patient to one or more multi-dimensional representations of a state of healthy controls ([0089]: “With respect to evaluating treatment of the brain networks 108, evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”).
Regarding claim 20, in view of the John/De Ridder combination, John discloses that the automatic adjustment of stimulation parameters comprising adjusting pulse amplitude, pulse width, pulse frequency parameters, and electrode polarity parameters ([0134]: “It is obvious that the linked rules can be applied to any characteristic of the stimulation protocol, including pulse width, pulse frequency, pulse shape, stimulation time, frequency, voltage, current, and any other stimulation characteristic that determines the treatment stimulation.”). While pulse amplitude and electrode polarity parameters are not directly described by John, it would be obvious to one having ordinary skill in the art at the effective filing date of the invention that these parameters would be included in the phrase “…any other stimulation characteristic that determines the treatment stimulation.” ([0134]).
Regarding new claim 21, in view of the John/De Ridder combination, John does not disclose that the EEG localization data indicates a plurality of data vertices, and wherein the subset of the cortical locations of the patient correspond to, and are selected from among the cortical locations in accordance with, the plurality of data vertices.
However, De Ridder teaches that the EEG localization data indicates a plurality of data vertices, and wherein the subset of the cortical locations of the patient correspond to, and are selected from among the cortical locations in accordance with, the plurality of data vertices ([col. 4, li. 29-36]: “…add an alpha frequency peak to stimulate primary and secondary cortical areas; add a beta frequency peak to stimulate association cortical areas, such as frontal cortex; add a theta frequency peak to stimulate the cingulate, hippocampus, amygdala; add a delta frequency peak to stimulate the brainstem, ventral tegmental area (VTA), nucleus accumbens/ventral medial prefrontal cortex (VMPFC).”; [col. 4, li. 38-44]: “…EEG or MEG measurements or any other measurement to obtain the individual peak frequency or the frequencies can be obtained from a database, for example a database containing a list of given frequencies and spectral structures for a brain structure or brain area.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the multi-dimensional representation John with the EEG localization data and corresponding cortical locations of De Ridder in order to aid in source localization computations.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the John/De Ridder combination further in view of Pappa (NASA Technical Memorandum 109066).
Regarding claim 8, in view of the John/De Ridder combination, John discloses that the analysis to determine a patient systemic response and characterizing an expected patient response to stimulation ([0091]: “The treatment criteria used to evaluate sensed data with respect to network events can utilize simple thresholds, statistical criteria, population or self-norm data, and may rely upon the output of modeling algorithms which compare the results of the modeling of current data to target values for the model, to see if the treatment criteria have been met.”).
The John/De Ridder combination does not disclose an eigenvalue realization algorithm (ERA).
However, Pappa teaches a methodology of using ERA for structural modal identification and minimum-order system realization. Pappa teaches an eigenvalue realization algorithm (pg. 1, Section 1.1: “The Eigensystem Realization Algorithm (ERA) is a multiple-input, multiple-output, time domain technique for structural modal identification and minimum-order system realization. The name Eigensystem Realization Algorithm reflects the combination of modal testing technology involving the identification of structural eigenvalues and eigenvectors (natural frequencies, damping, mode shapes, and modal masses) and system realization theory involving the construction of state-space models [A,B,C,D] for modern control design. ERA was introduced in 1984 by the author and Dr. Jer-Nan Juang as a tool for system identification of future large space structures.”)
The instant application’s Specification states that “the eigenvalue system characterization approach …be employed to select stimulation parameters and/or stimulation pattern”, as well calculating “the A, B, C, D matrix of the state space equation through system identification operations”, so it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the John/De Ridder combination’s analysis to determine a patient systemic response with the eigenvalue realization algorithm of Pappa to characterize an expected patient response to stimulation.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over the John/De Ridder/Pappa combination further in view of Moffit (US 2011/0093045) (cited previously).
Regarding claim 10, in view of the John/De Ridder/Pappa combination, John discloses representing the multi-dimensional representation of a state of the patient ([0082]: “Rather than occurring within the BND itself, under the direction of a physician, abnormal activity in dispersed portions of a network may be measured in a number of manners, for example, by superposition of three dimensional source localization of the generators of quantitative EEG (QEEG) measurements.”) relative to one or more multi-dimensional representations of states of health controls ([0089]: “… evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”).
The John/De Ridder/Pappa combination does not disclose providing a user interface display to a clinician.
Moffitt teaches a system for a neurostimulation device and method for estimating volume of activation in tissue. This prior art reference is the reference is from the same field of endeavor as the claimed invention and therefore analogous, even if it addresses a different problem. While Moffitt teaches providing a user interface display to a clinician ([0054]: “In the illustrated embodiment, the display screen 52 is a lighted flat panel display screen…”). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the controls of the John/De Ridder/Pappa combination to include a graphical user interface or display screen in order to aid the clinician in neurostimulation parameter adjustment.
Regarding claim 11, in view of the combination set forth in claim 10, John discloses representing changes to the multi-dimensional representation of a state of the patient ([0082]: “Rather than occurring within the BND itself, under the direction of a physician, abnormal activity in dispersed portions of a network may be measured in a number of manners, for example, by superposition of three dimensional source localization of the generators of quantitative EEG (QEEG) measurements.”) relative that were measured in response to multiple changes in stimulation parameters relative to one or more multi-dimensional representations of states of health controls ([0089]: “… evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”).
The John/De Ridder/Pappa combination does not teach providing a user interface display to a clinician of a path graphical element.
However, Moffitt teaches providing a user interface display to a clinician ([0054]: “In the illustrated embodiment, the display screen 52 is a lighted flat panel display screen…”) of a path graphical element ([0088]: “By reviewing the graphical representation of the [volume of activation], a user may determine whether the VOA representation properly coincides with the target anatomical region to be stimulated.”). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the controls of the John/De Ridder/Pappa combination to include a graphical user interface or display screen of a path graphical element in order to aid the clinician in neurostimulation parameter adjustment.
Regarding claim 12, in view of the combination set forth in claim 10, the John/De Ridder/Pappa combination does not disclose that the neurostimulation therapy is selected from the listing consisting of: spinal cord stimulation, dorsal root ganglion stimulation, peripheral nerve stimulation, cortical stimulation, and deep brain stimulation.
However, Moffitt teaches that the neurostimulation therapy could be selected from the listing consisting of: spinal cord stimulation, peripheral nerve stimulation, and cortical stimulation ([0040]: “…the present invention may be used as part of a spinal cord stimulator, …a stimulator configured to produce coordinated limb movement, a cortical stimulator, peripheral nerve stimulator, …or in any other neural stimulator configured to treat urinary incontinence, sleep apnea, shoulder subluxation, headache, etc.”). Moffitt additionally teaches deep brain stimulation ([0019]: “FIG. 1 is a plan view of an embodiment of a deep brain stimulation (DBS) system.”).
While Moffitt does not explicitly teach dorsal root ganglion stimulation, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention that this is implied along with Moffit teaching spinal cord stimulation. Additionally, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the John/De Ridder/Pappa combination’s modulation of brain networks to further include the neurostimulation therapies taught by Moffitt.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 and 7-20 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-5 and 7-20, respectively, of co-pending Application No. 17/968,739. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application would be anticipated by the claims of the co-pending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, the instant application discloses obtaining electroencephalogram (EEG) data corresponding to a neurological response of the patient to the electrical pulses. Claim 1 of the copending application 17/968,739 (hereinafter App. ‘739) teaches “obtaining patient data corresponding to a physiological response of the patient to the electrical pulses”. While not identical, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention that the patient data and physiological response of App. ‘739 are anticipated by the instant application, as they are analogous to EEG data and neurological response respectively.
Additionally, the instant application teaches “forming, using the EEG localization data, a multi-dimensional representation of a state of the patient by selecting a predetermined number of features corresponding to activity within respective frequency bands at a subset of cortical locations of the patient”. App. ‘739 teaches “forming, from the patient data, a multi-dimensional representation of a state of the patient by selecting a predetermined number of features corresponding to patient data corresponding to a physiological response of the patient to the electrical pulses, the features including a plurality of different physiological features of the patient” (claim 1). While not identical, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention that the patient data and the physiological response of App. ‘739 are anticipated by the instant application, as they are analogous to EEG localization data and the activity within respective frequency bands at a subset of cortical locations respectively.
Regarding claims 2-5, those of the instant application are identical to claims 2-6 of copending App. ‘739.
Regarding claim 7, the claim of the instant application is nearly identical to claim 7 of copending App. ‘739.
Regarding claims 8-16, those of the instant application are identical to claims 8-16 of copending App. ‘739.
Regarding claim 17, the claim of the instant application is nearly identical to claim 17 of copending App. ‘739.
Regarding claim 18, the claim of the instant application is identical to claim 18 of copending App. ‘739.
Regarding claim 19, the claim of the instant application is nearly identical to claim 19 of copending App. ‘739.
Regarding claim 20, the claim of the instant application is identical to claim 20 of copending App. ‘739.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-Th 7:30am-5:00pm.
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 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796