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 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, 11, 13, 23, is 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. The amendments to claim 1 state “wherein the neurological state comprises unperceived pain…” There is no description in the specification showing or stating “unperceived pain” and that the “unperceived pain comprises a sub-threshold or unconscious pain”. The applicant shows no support in the arguments or anywhere in citations in the specification for this new claim language.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donoghue et al. (US 20210267523) in view of Young et al (US 20160144165), both cited previously.
Regarding claim 1, Donoghue discloses performing deep brain stimulation on a brain of a patient (sections 0189, 0197, System 10 can also provide stimulation to the brain (e.g. electrical stimulation such as transcranial electrical stimulation delivered by one or more sensors and/or direct cerebral stimulation e.g. deep brain stimulation, DBS. Sensors can be configured and arranged to be positioned below the skin and under the skull, and to stimulate brain tissue areas that in current clinical practice are stimulated using a commercially available deep brain stimulation (DBS) device), the system comprising: one or more recording arrays 160 (section 0095, Implantable device can include lead assembly which can include one or more electrodes and/or other sensing elements, sensors, that provide signals related to one or more physiologic parameters of the patient e.g. electrical activity of the brain and/or other tissue of the patient.) configured to be minimally invasively inserted to a target recording site of the brain (Section 0214, implantable device is configured to be implanted in a minimally invasive procedure), and configured to record electrical signals from the target recording site (section 0194, one or more sensors of system record EEG or other brain activity); at least one stimulation array configured to be inserted to a target stimulation site within a deep brain region of the brain (sections 0189, 0197, System 10 can also provide stimulation to the brain (e.g. electrical stimulation such as transcranial electrical stimulation delivered by one or more sensors and/or direct cerebral stimulation e.g. deep brain stimulation, DBS. Sensors can be configured and arranged to be positioned below the skin and under the skull, and to stimulate brain tissue areas that in current clinical practice are stimulated using a commercially available deep brain stimulation (DBS) device), each stimulation array comprising at least one stimulation electrode configured to deliver electrical stimulation to the target stimulation site (section 0187, system can provide always available neurofeedback, and/or stimulation e.g. transcranial stimulation provided by sensors and/or transcranial, epidural, subdural and/or other stimulation provided by any stimulation element of system); a processor 120; and a non-transitory, computer-readable medium storing instructions that, when executed, cause the processor to: receive, via the one or more recording arrays, one or more recorded signals from the target recording site (Section 0095, Implantable device can include lead assembly which can include one or more electrodes and/or other sensing elements, sensors, that provide signals related to one or more physiologic parameters of the patient e.g. electrical activity of the brain and/or other tissue of the patient), determine a neurological state of the brain based on the one or more recorded signals (section 0176, One layer of analysis provided by system 10 (e.g. via algorithm 50 and/or server 500) can be a statistical report of EEG features (e.g. continuously gathered EEG features such as power in a frequency band, epileptiform, and/or other pathological activity). Another layer of analysis can include taking all recorded variables as input features to define brain states at the multi-dimensional level. Recorded EEG can be enhanced with recordings from other physiological monitoring (e.g. as recorded by one or more sensors of system 10 as described herein). Brain states can be reflected in nearly all physiological variables, which allows not only the identification of temporal patterns in brain activity but also the correlation of these patterns with other physiological variables and rhythms), and deliver, via the at least one stimulation array, electrical stimulation to the target stimulation site based on the determined neurological state, wherein the electrical stimulation is configured to electrically stimulate the brain (Section 0193, 0195, system is configured to diagnose, prognose, and/or treat dyslexia used herein to include dyslexia and other dyscognitive disorders such as dyscalculia, dysphasia, and the like. System can be configured to provide brain stimulation e.g. transcranial stimulation provided by sensors positioned on the top of the skull or other stimulation as described herein to treat dyslexia. System 10 can be configured to stimulate tissue of the patient, such as stimulation that is delivered based on the analysis of brain activity and/or other physiologic parameter information recorded by system 10 e.g. recorded by sensors 160 and/or other sensors of system 10).
However Donoghue does not disclose each recording array comprising a plurality of recording electrodes having a spacing of less than about 1 mm therebetween, each recording electrode having a diameter of less than about 1 mm. Young discloses each recording array comprising a plurality of recording electrodes 132 having a spacing of less than about 1 mm therebetween, each recording electrode having a diameter of less than about 1 mm (section 0092, electrodes may have a diameter of a several hundreds of microns, e.g., when electrode surface take the shape of a circular dot, and may be spaced apart from one another at a distance of about one to two hundred microns). This allows proper placement and proper effectiveness of electrodes in sensing electrical signals. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing this application, to modify the device of Donoghue by adding a plurality of recording electrodes having a spacing of less than about 1 mm therebetween, each recording electrode having a diameter of less than about 1 mm as taught by Young in order to facilitate proper placement and proper effectiveness of electrodes in sensing electrical signals.
Regarding claim 2, Donoghue discloses the one or more recording arrays comprise a thin-film electrode array (Fig. 3A-C, section 0103, Leads can each comprise a substrate on which sensors are mounted. The substrate of lead can have a relatively flat cross section).
Regarding claim 3, Donoghue discloses the one or more recording arrays comprise a two-dimensional electrode array (Figs. 3A-C).
Regarding claim 7, Donoghue discloses neurological state is selected from epilepsy, Parkinson's disease, depression, and pain (Section 0169, 0189, system is configured to diagnose, prognose, and/or treat, one, two, or more medical conditions selected from the group consisting of: epilepsy, Parkinson's disease, pain. System is configured to diagnose, prognose, and/or treat neuropsychiatric disorders. Among psychiatric disorders, depression).
Regarding claim 8, Donoghue discloses the electrical stimulation is configured to electrically stimulate the brain to prevent or reduce one or more of dyskinesia, tremor, and freezing of gait (Section 0169, 0174, System is configured to treat, one, two, or more medical conditions selected from the group consisting of a movement disorder or essential tremor. System can be further configured to stimulate tissue of the patient, such as electrical stimulation delivered by implantable device e.g. transcranial stimulation delivered by sensors or direct cerebral stimulation).
Regarding claim 9, Donoghue discloses the neurological state is a pre-seizure state associated with onset of an epileptic seizure, and wherein the electrical stimulation is configured to electrically stimulate the brain to prevent the epileptic seizure (section 0176, The characterization can be used to predict or (early) detect onsets of events (such as seizures).
Regarding claim 10, Donoghue discloses the neurological state is pain, and wherein the electrical stimulation is configured to electrically stimulate the brain to prevent the perception of the pain (Section 0168, System can be configured to perform neurorehabilitation, manage and/or treat pain, and/or function as an assistive technology to the patient).
Regarding claim 12, Donoghue discloses the target stimulation site of the brain is selected from the group consisting of a ventrolateral thalamus, a globus pallidus, and a subthalamic nucleus (Section 0197, stimulated tissue includes, but is not limited to, tissue of the: motor cortex; nucleus accumbens; subthalamic nucleus (STN); and/or globus pallidus internal).
Regarding claim 13, Donoghue discloses performing deep brain stimulation on a brain of a patient (sections 0189, 0197, System 10 can also provide stimulation to the brain (e.g. electrical stimulation such as transcranial electrical stimulation delivered by one or more sensors and/or direct cerebral stimulation e.g. deep brain stimulation, DBS. Sensors can be configured and arranged to be positioned below the skin and under the skull, and to stimulate brain tissue areas that in current clinical practice are stimulated using a commercially available deep brain stimulation (DBS) device), the method comprising: receiving one or more recorded signals from a target recording site via one or more recording arrays positioned at the target recording site (section 0095, Implantable device can include lead assembly which can include one or more electrodes and/or other sensing elements, sensors, that provide signals related to one or more physiologic parameters of the patient e.g. electrical activity of the brain and/or other tissue of the patient), determining a neurological state of the brain based on the one or more recorded signals (section 0176, One layer of analysis provided by system 10 (e.g. via algorithm 50 and/or server 500) can be a statistical report of EEG features (e.g. continuously gathered EEG features such as power in a frequency band, epileptiform, and/or other pathological activity). Another layer of analysis can include taking all recorded variables as input features to define brain states at the multi-dimensional level. Recorded EEG can be enhanced with recordings from other physiological monitoring (e.g. as recorded by one or more sensors of system 10 as described herein). Brain states can be reflected in nearly all physiological variables, which allows not only the identification of temporal patterns in brain activity but also the correlation of these patterns with other physiological variables and rhythms); and delivering, based on the determined neurological state, electrical stimulation to a target stimulation site via at least one stimulation array positioned at the target stimulation site to electrically stimulate the brain, wherein the target stimulation site is within a deep brain region of the brain (Section 0193, 0195, system is configured to diagnose, prognose, and/or treat dyslexia used herein to include dyslexia and other dyscognitive disorders such as dyscalculia, dysphasia, and the like. System can be configured to provide brain stimulation e.g. transcranial stimulation provided by sensors positioned on the top of the skull or other stimulation as described herein to treat dyslexia. System can be configured to stimulate tissue of the patient, such as stimulation that is delivered based on the analysis of brain activity and/or other physiologic parameter information recorded by system e.g. recorded by sensors and/or other sensors of system).
However Donoghue does not disclose each recording array comprising a plurality of recording electrodes having a spacing of less than about 1 mm therebetween, each recording electrode having a diameter of less than about 1 mm; Young discloses each recording array comprising a plurality of recording electrodes having a spacing of less than about 1 mm therebetween, each recording electrode having a diameter of less than about 1 mm (section 0092, electrodes may have a diameter of a several hundreds of microns, e.g., when electrode surface take the shape of a circular dot, and may be spaced apart from one another at a distance of about one to two hundred microns). This allows proper placement and proper effectiveness of electrodes in sensing electrical signals. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing this application, to modify the device of Donoghue by adding a plurality of recording electrodes having a spacing of less than about 1 mm therebetween, each recording electrode having a diameter of less than about 1 mm as taught by Young in order to facilitate proper placement and proper effectiveness of electrodes in sensing electrical signals.
Regarding claim 14, Donoghue discloses the one or more recording arrays comprise a thin-film electrode array (Fig. 3A-C, section 0103, Leads can each comprise a substrate on which sensors are mounted. The substrate of lead can have a relatively flat cross section).
Regarding claim 15, Donoghue discloses the one or more recording arrays comprise a two-dimensional electrode array (Figs. 3A-C).
Regarding claim 19, Donoghue discloses neurological state is selected from epilepsy, Parkinson's disease, depression, and pain (Section 0169, 0189, system is configured to diagnose, prognose, and/or treat, one, two, or more medical conditions selected from the group consisting of: epilepsy, Parkinson's disease, pain. System is configured to diagnose, prognose, and/or treat neuropsychiatric disorders. Among psychiatric disorders, depression).
Regarding claim 20, Donoghue discloses the electrical stimulation is configured to electrically stimulate the brain to prevent or reduce one or more of dyskinesia, tremor, and freezing of gait (Section 0169, 0174, System is configured to treat, one, two, or more medical conditions selected from the group consisting of a movement disorder or essential tremor. System can be further configured to stimulate tissue of the patient, such as electrical stimulation delivered by implantable device e.g. transcranial stimulation delivered by sensors or direct cerebral stimulation).
Regarding claim 21, Donoghue discloses the neurological state is a pre-seizure state associated with onset of an epileptic seizure, and wherein the electrical stimulation is configured to electrically stimulate the brain to prevent the epileptic seizure (section 0176, The characterization can be used to predict or (early) detect onsets of events (such as seizures).
Regarding claim 22, Donoghue discloses the neurological state is pain, and wherein the electrical stimulation is configured to electrically stimulate the brain to prevent the perception of the pain (Section 0168, System can be configured to perform neurorehabilitation, manage and/or treat pain, and/or function as an assistive technology to the patient).
Regarding claim 24, Donoghue discloses the target stimulation site of the brain is selected from the group consisting of a ventrolateral thalamus, a globus pallidus, and a subthalamic nucleus (Section 0197, stimulated tissue includes, but is not limited to, tissue of the: motor cortex; nucleus accumbens; subthalamic nucleus (STN); and/or globus pallidus internal).
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.
Claim 1-6, 13-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6, 12-17 of copending Application No. 18491333 (reference application), cited previously. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and the copending application claims one or more recording arrays configured to be minimally invasively inserted to a target recording site of the brain, each recording array comprising a plurality of recording electrodes having a spacing of less than about 1 mm therebetween, each recording electrode having a diameter of less than about 1 mm and configured to record electrical signals from the target recording site; at least one stimulation array configured to be inserted to a target stimulation site within a deep brain region of the brain, each stimulation array comprising at least one stimulation electrode configured to deliver electrical stimulation to the target stimulation site; a processor; and a non-transitory, computer-readable medium storing instructions that, when executed, cause the processor to: receive, via the one or more recording arrays, one or more recorded signals from the target recording site, determine a neurological state of the brain based on the one or more recorded signals, and deliver, via the at least one stimulation array, electrical stimulation to the target stimulation site based on the determined neurological state, wherein the electrical stimulation is configured to electrically stimulate the brain.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6, 13-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/
Primary Examiner, Art Unit 3796