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 § 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.
Claims 1, 12, 16, 31,40, 43 and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buytaert (International Publication Number: WO 2021038355 A1, hereinafter “Buytaert”- APPLICANT CITED).
Regarding claims 1, 12, 31 and 46, Buytaert teaches a method, one or more non-transitory computer readable storage media comprising instructions that, when executed by a processor, cause the processor to perform steps, an implantable motor disorder stimulator system (e.g. Figs. 2A, B, [0033], [0035], [0037], Figs. 4A, 5), comprising:
one or more electrodes (e.g. 154 Fig.2A, [0043], [0044]) configured to be implanted at an inner ear of a recipient with a motor disorder;
an implantable stimulator unit (e.g. 134 Fig.2A) configured to deliver, via at least one of the one or more electrodes, electrical stimulation signals to a vestibular system of the inner ear of the recipient (e.g. [0030], [0044],[0049]); and
at least one processor configured to:
following delivery of the electrical stimulation signals to a vestibular system, analyze one or more motor disorder symptoms experienced by the recipient (e.g. [0041]: sensing using motion sensors 149 gravitoinertial/ linear/ rotational accelerations, [0069]-[0074],[0082]: extraocular vestibular evoked myogenic potential (oVEMP) are sensed and consider as sensing of fine motor skills) and
adjust, based on the analyzing of the one or more motor disorder symptoms experienced based on the recipient, one or more parameters of the electrical stimulation signals to reduce the one or more motor disorder symptoms experienced by the recipient (e.g. [0069]-[0074],[0082]: extraocular vestibular evoked myogenic potential (oVEMP) are sensed and consider as sensing of fine motor skills and used to control/ adjust the stimulation, [0052]: attributes of a recorded vestibular evoked myogenic potential (or the lack thereof) can then be used to, for example, control, adjust, or otherwise set parameters of the electrical stimulation signals delivered to the otolith organs 111).
Regarding claim 40, Buytaert teaches wherein the instructions operable to adjust one or more parameters of the electrical stimulation signals based on the monitoring of the one or more target motor disorder symptoms of the recipient comprise instructions operable to: adjust a level of the electrical stimulation signals (e.g. [0079], [0080]: processor 142 may determine that the level of the stimulation signals is too low or too high and a current level adjustment may be initiated.).
Regarding claims 16 and 43, Buytaert teaches delivering the electrical stimulation signals to a vestibular system of the recipient comprises: delivering the electrical stimulation signals to at least the inferior branch of the vestibular nerve through one or more of the otolith organs (e.g. [0030]).
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.
Claims 2, 3, 5 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Buytaert (International Publication Number: WO 2021038355 A1, hereinafter “Buytaert”- APPLICANT CITED) in view of Machado et al (U.S. Patent Application Publication Number: US 2016/0128621 A1, hereinafter “Machado”).
Regarding claim 2, Buytaert teaches the claimed invention as discussed above except for assessing the fine motor skills of the recipient includes assessing handwriting of the recipient.
Macahdo teaches that it is well known to evaluate movement disorders by assessing fine motor skills of a patient using a stylus with sensors (e.g. Abstract, [0003], [0015], [0016]) that can be used for adjusting stimulation. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings Buyteart to also include assessing of handwriting of the recipient for adjustment of stimulation as taught by Machado in order to provide the predictable results of being able to provide a more effective stimulation therapy.
Regarding claims 3 and 5, Buytaert teaches the claimed invention as discussed above and while they teach that they analyze the extraocular vestibular evoked myogenic potential (oVEMP) are sensed and analyzed to control/adjust the stimulation, they do not specifically teach assessing fine motor skills comprises assess hand tremors of the recipient and capturing one or more sensor inputs relating to linear acceleration, angular motion, or angular acceleration of a hand of the recipient.
Macahdo teaches that it is well known to evaluate movement disorders by assessing fine motor skills of a patient using a stylus with sensors (e.g. Abstract, [0003], [0015], [0016]) and capturing one or more sensor inputs relating to linear acceleration, angular motion, or angular acceleration of a hand of the recipient (e.g. [0031], [0034],[0035]) that can be used for adjusting stimulation. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings Buyteart to also include assessing of handwriting of the recipient for adjustment of stimulation as taught by Machado in order to provide the predictable results of being able to provide a more effective stimulation therapy.
Regarding claim 9-11, Buytaert teaches the claimed invention as discussed above except for assessing the fine motor skills of the recipient includes: confirming that the recipient suffers from a motor disorder, wherein confirming that the recipient suffers from a motor disorder includes: confirming that the recipient suffers from Parkinson's disease, confirming that the recipient suffers from ataxia.
Macahdo teaches that it is well known to evaluate and confirm movement disorders such as Parkinson’s disease and ataxia (e.g. [0081]) to confirm by assessing fine motor skills of a patient using a stylus with sensors (e.g. Abstract, [0003], [0015], [0016]) that can be used for adjusting stimulation. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings Buyteart to also include assessing of handwriting of the recipient to determine movement disorders like Parkinson’s disease and detect ataxia for adjustment of stimulation as taught by Machado in order to provide the predictable results of being able to provide a more effective stimulation therapy.
Claims 3, 4, 6, 37-39, 47 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Buytaert (International Publication Number: WO 2021038355 A1, hereinafter “Buytaert”- APPLICANT CITED) in view of Van de Heuvel et al (U.S. Patent Application Publication Number: US 2021/0402185 A1, hereinafter “Van den Heuvel”- APPLICANT CITED).
Regarding claims 3, 4, 37, 38, 47 and 48, Buytaert teaches the claimed invention as discussed above and while they teach that they analyze the extraocular vestibular evoked myogenic potential (oVEMP) are sensed and analyzed to control/adjust the stimulation, they do not specifically teach that to analyze the one or more motor disorder symptoms experienced by the recipient the at least one processor is configured to: receive an output from one or sensors relating to head tremors of the recipient; and analyze the head tremors of the recipient and wherein to adjust the one or more parameters of the electrical stimulation signals to reduce the one or more motor disorder symptoms experienced by the recipient, the at least one processor is configured to: adjust the electrical stimulation signals to reduce the head tremors of the recipient.
In a similar field of endeavor, Van den Heuvel teaches a vestibular system and method for treating motor disorders (e.g. [0029]: balance disorder with complete or partial loss of vestibular function/sensation that leads to imbalance/instability problems, dizziness, difficulty walking in darkness without falling, blurred or unsteady vision during head movement which is considered as head tremors) comprising sensing and analyzing head movement to stimulate the vestibular nerve to reduce head movement (i.e. head tremors). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Buytaert to also sense and analyze head movement data for adjustment of the vestibular stimulation as taught by Van Den Heuvel in order to provide the predictable results of replicating the balance provided to the brain similar to a fully functional vestibular system.
Regarding claims 6 and 39, Buytaert teaches the claimed invention as discussed above and while they teach that they analyze the extraocular vestibular evoked myogenic potential (oVEMP) are sensed and analyzed to control/adjust the stimulation, they do not specifically teach that assessing the fine motor skills of the recipient includes assessing a gait of the recipient.
In a similar field of endeavor, Van den Heuvel teaches a vestibular system and method for treating motor disorders comprising assessing gait of the recipient (e.g. [ 0087]: one or more motion sensors 630 may be similar to sensors 130 of FIGS. 2A, 2B, and 3, and are configured to sense/ measure translation and/or rotation of the recipient's body and/or one or more of recipient's body parts which is considered as assessing gait of the user). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Buytaert to include sensors to sense measure and analyze the body parts and thus gait in order to provide the predictable results of assessing the movement of the recipient to provide a more effective therapy.
Claims 7, 8, 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Buytaert (International Publication Number: WO 2021038355 A1, hereinafter “Buytaert”- APPLICANT CITED) in view of Risi et al (U.S. Patent Application Publication Number: US 2021/0146123 A1, hereinafter “Risi”).
Regarding claims 7 and 8, Buytaert teaches the claimed invention as discussed above except for assessing the fine motor skills of the recipient includes: performing one or more intraoperative tests; and assessing the fine motor skills of the recipient based on the one or more intraoperative tests and wherein performing one or more intraoperative tests comprises: obtaining one or more Electrically Evoked Compound Action Potential (ECAP) measurements from the vestibular system of the recipient.
In a similar field of endeavor, Risi teaches performing one or more intraoperative tests by obtaining one or more Electrically Evoked Compound Action Potential (ECAP) measurements from the vestibular system of the recipient and assessing the fine motor skills of the recipient based on the ECAPs (e.g. [0014], [0059]: facial nerve, [0061]: ocular reflex). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Buytaert to include intraoperative assessment based on ECAPs as taught by Risi in order to provide the predictable results of ensuring proper placement of the stimulation electrodes.
Regarding claims 35 and 36, Buytaert teaches the claimed invention as discussed above except for instructions operable to: monitor the recipient to determine whether the electrical stimulation signals have cross-stimulated one or more non-target nerve areas and determine that the electrical stimulation signals have affected one or more non-target areas; and adjust the electrical stimulation signals to reduce cross-stimulation of the one or more non-target nerve areas.
In a similar field of endeavor, Risi teaches instructions to: monitor the recipient to determine whether the electrical stimulation signals have cross-stimulated one or more non-target nerve areas by obtaining one or more Electrically Evoked Compound Action Potential (ECAP) measurements from the vestibular system of the recipient and determine that the electrical stimulation signals have affected one or more non-target areas; and adjust the electrical stimulation signals to reduce cross-stimulation of the one or more non-target nerve areas. (e.g. [0061]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Buytaert to include intraoperative assessment based on ECAPs as taught by Risi in order to provide the predictable results of ensuring proper placement of the stimulation electrodes.
Claims 13-16, 42 and 49-51 are rejected under 35 U.S.C. 103 as being unpatentable over Buytaert (International Publication Number: WO 2021038355 A1, hereinafter “Buytaert”- APPLICANT CITED) in view of Jager et al (U.S. Patent Application Publication Number: US 2013/0184788 A1 hereinafter “Jager”).
Regarding claims 13-16, Buytaert teaches the claimed invention as discussed above except for delivering the electrical stimulation signals independent of any sensor inputs relating to linear acceleration, angular motion, or angular acceleration of the head or hands of the recipient and wherein delivering the electrical stimulation signals further comprises: delivering at least a first continuous pulse train via at least a first one of a plurality of stimulating elements configured to be implanted at an inner ear of the recipient and wherein delivering the electrical stimulation signals further comprises: delivering at least a first continuous pulse train via at least a first one of a plurality of stimulating elements configured to be implanted in the inner ear of the recipient.
In a similar field of endeavor, Jager teaches a vestibular stimulation system and method comprising delivering the electrical stimulation signals independent of any sensor inputs (e.g. Abstract: a sensor independent mode wherein the motion sensor is unpowered and the vestibular stimulation signals are developed independently of the motion signal) and delivering at least a first continuous pulse train (e.g. [0021], [0024]: power saving mode with constant pacing) via at least a first one of a plurality of stimulating elements configured to be implanted at an inner ear of the recipient (e.g. Fig.1, [0018]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Buytaert to provide a continuous stimulation irrespective of the sensor signals as taught by Jager in order to provide the predictable results of providing a more independent and effective patient- based therapy.
Regarding claim 42, Buytaert teaches the claimed invention as discussed above except for instructions operable to deliver at least a first continuous pulse train via the at least one electrode.
In a similar field of endeavor, Jager teaches a vestibular stimulation system and method that comprises instructions for delivering at least a continuous pulse train via an electrode (e.g. [0021],[0024]: power saving mode with constant pacing). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Buytaert to provide a continuous stimulation as taught by Jager in order to provide the predictable results of providing a more independent and effective therapy.
Regarding claims 49-51, Buytaert teaches the claimed invention as discussed above except for the at least one processor being configured to: activate a predetermined stimulation sequence comprising one or more continuous electrical pulse trains and deliver the one or more continuous electrical pulse trains for period of time in response to sensing at least one or hand or head tremors of the recipient.
In a similar field of endeavor, Jager teaches a vestibular stimulation system and method that comprises a sensor mode that senses head motion of a patient (e.g. [0009]) and activate a predetermined stimulation sequence comprising one or more continuous electrical pulse trains and deliver the one or more continuous electrical pulse trains for period of time (e.g. [0021], [0022]: a constant pacing mode with a soft power up and soft power down where the stimulation signals are gradually increased or decreased to reduce unpleasant sensation). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Buytaert to further include the constant pacing mode for a predetermined time with soft power up or soft power down in response to the sensor sensing head movement as taught by Jager in order to provide the predictable results of a more effective therapy and reducing unpleasant sensation during the changes in mode.
Claims 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Buytaert (International Publication Number: WO 2021038355 A1, hereinafter “Buytaert”- APPLICANT CITED) in view of DiLorenzo (U.S. Patent Application Publication Number: US 2007/0142862 hereinafter “DiLorenzo”).
Regarding claims 32-34, Buytaert teaches the claimed invention as discussed above except for prior to delivering the electrical stimulation signals, registering the one or more target motor disorder symptoms of the recipient, determining a baseline level for the one or more target motor disorder symptoms of the recipient, determining a present level for the one or more target motor disorder symptoms of the recipient; and comparing the present level for the one or more target motor disorder symptoms to the baseline level for the one or more target motor disorder symptoms.
DiLorenzo teaches that it is well known to monitor symptoms of a motor disorder such a Parkinson’s disease and determine baseline level motor disorder symptoms and comparing the present level to the baseline level to monitor for the progression of the patient’s neurological disease state (e.g. [0155]: EMG signals are sensed and processed and patients with Parkinson’s disease exhibit a reduction in eyeblinking frequency and this parameter is sensed as a measure of disease severity and response to treatment. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings Buytaert to determine baseline level motor disorder symptoms and compare present levels with baseline symptom levels as taught by DiLorenzo in order to provide the predictable results of having a more controlled and quantified assessment of the therapy outcomes.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Buytaert (International Publication Number: WO 2021038355 A1, hereinafter “Buytaert”- APPLICANT CITED) in view of Della Santina et al (U.S. Patent Application Publication Number: US 2015/0039057 A1 hereinafter “Della Santina”).
Regarding claim 41 Buytaert teaches the at least one electrode comprises a plurality of stimulating elements as discussed above but does not specifically teach the instructions operable to: change which of the plurality of stimulating elements are used to deliver the electrical stimulation signals.
In a similar field of endeavor, Della Santina teaches an implantable vestibular stimulation prosthesis and further teaches current steering to selectively change which of a plurality of electrodes are used to deliver stimulation improve the neural selectivity (e.g. [0038],[0118], [0126]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Buytaert to include instructions for current steering to selectively activate stimulating electrodes to deliver stimulation as taught by Della Santina in order to provide the predictable results of providing a more effective therapy by providing more control over neural selectivity.
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Buytaert (International Publication Number: WO 2021038355 A1, hereinafter “Buytaert”- APPLICANT CITED) in view of Whitehurst et al (U.S. Patent Number: US 7151961 hereinafter “Whitehurst”).
Regarding claim 52, Buytaert teaches the claimed invention as discussed above except for the at least one processor being configured to: monitor at least one of hand or head tremors of the recipient; determine that the at least one of the hand or head tremors of the recipient are below a threshold level; and adjust the one or more stimulation parameters of the electrical stimulation signals following determining that the at least one of the hand or head tremors of the recipient are below the threshold level.
In a similar field of endeavor, Whitehurst an implantable stimulation system for treating Parkinson’s disease and that comprises an accelerometer that senses head tremors of a patient and adjusting the stimulation based on the threshold of the head tremors (e.g. Col. 14 lines 10-24) and thus they teach that the processor is configured to adjust one or more stimulation parameters when the head motion is below a threshold level.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Buytaert with adjusting the stimulation when the head motion is below a certain threshold level as taught by Whitehurst in order to provide the predictable results of providing a more effective therapy for patients with significant head tremor as a component of their movement disorder
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lattner et al (U.S. Patent Application Publication Number: US 2002/0072781 A1 hereinafter “Lattner”) teaches a vestibular stimulation system and method comprising a sensor and also teaches eliminating the sensor in favor of applying a predetermined pattern of stimulation to the patient (e.g. Abstract).
Xu et al (U.S. Patent Application Publication Number: US 2022/0233855 A1 hereinafter “Xu”) teaches treatment of equilibrium disorders and improving gait and balance and teaches a sensor, identifying a movement pattern consistent with an equilibrium disorder, estimating characteristics of the equilibrium disorder, and applying stimulation to at least one of the right ear, left ear, or brainstem of the device wearer of an ear-worn device wherein the stimulation comprises an excitatory/ inhibitory stimulation and wherein the stimulation transducer 1202 can include one or more electrodes for electrical nerve stimulation (e.g. abstract, [0149]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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