DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see Remarks dated 06/29/2026, with respect to the rejection of claims 19-38 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Simon et al (US 20140214120 A1) in view of Dayan et al (US 20160331472 A1).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 19-38 are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al (US 20140214120 A1) in view of Dayan et al (US 20160331472 A1).
Regarding claim 19, Simon teaches a method of treating vascular spasm of a subject comprising:
delivering a neurostimulator (300) comprising an implant body and a lead having at least one electrode (see Figs. 1A-1C, [0058-0059]; nerve modulating device 300 also known as an implantable lead having one or more electrodes 340)
to a selected site in the subject in a minimally invasive manner with a delivery device (see [0046]; advancing an electrode lead or leads transnasally to a target site at or adjacent to a nerve within the patient),
implanting the neurostimulator in the subject, such that the at least one electrode on the lead of the neurostimulator is positioned proximate a sphenopalatine ganglion (SPG) of the subject (see [0046-0047]; the electrode lead(s) are delivered through one or both nostrils of the patient to the nasopharyngeal mucosa posterior to the middle turbinate adjacent to the SPG);
powering the neurostimulator wirelessly with a remote transducer (370) that is in electrical communication with the neurostimulator (see [0058-0059]; the external controller 370 supplies power and control of implanted device 300 and is preferably both portable and rechargeable),
applying electrical stimulation with the neurostimulator via the at least one electrode (340) to at least one of excite or inhibit the SPG of the subject (see [0076]; the electrode and signal generator are primarily intended for stimulation of the SPG, [0046]; electrical waveforms for use with the stimulator may be used to preferentially block or otherwise modulate the activity of particular nerves in and around the SPG); and
modulating activity of the SPG of the subject with the electrical stimulation applied by changing frequency of a waveform delivered by the neurostimulator to the SPG of the subject to control vascular spasm in the subject (see [0061-0063]; modulating the stimulation power to the nerve by altering the number and timing of the pulses).
Simon is silent regarding wherein the neurostimulator is delivered to a selected site via a delivery device having a steerable tip.
Dayan teaches an implant and delivery system for a neural stimulator, wherein the neural stimulator (32) is delivered to a selected site in the subject in a minimally invasive manner with a delivery device (34) having a steerable tip (see Dayan [0241]; neural stimulator implant 32 is coupled to steerable delivery guide 34 such that both the implant and the guide 34 are advanced through the greater palatine foramen into the greater palatine canal and implant 32 is brought into a vicinity of a sphenopalatine ganglion, steerable guide 34 is retracted after the placement of implant 32, [0247]; slide bar 57 provides steering functionality for facilitating advancement of guide 34).
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 Simon’s method for delivering a neurostimulator to a selected site using a delivery device with Dayan’s steerable delivery device. One of ordinary skill in the art would have been motivated to make this modification because typically, the greater palatine canal is curved and has multiple naturally formed openings, so proper steering of the delivery device allows for the neurostimulator to be implanted at the desired site proximate a sphenopalatine ganglion (Dayan [0249]).
Regarding claim 20, Simon in view of Dayan teaches the method of claim 19, further comprising transmitting data wirelessly from the neurostimulator (380) to a personal electronic device (380), wherein the transmitted data relates at least to the electrical stimulation applied to the SPG of the subject (see Simon [0108]; circuitry of a processor in the implanted signal generator that couple communicate a signal back to the power/control unit, this signal could contain status information such as voltage, current, number of pulses applied, or other applicable data, [0027]; the system may also comprise a docking station wherein the docking station and stimulation device may also transmit data to one another wirelessly).
Regarding claim 21, Simon in view of Dayan teaches the method of claim 20, wherein the personal electronic device comprises one or more of a smart phone, tablet, or personal computer (see Simon Fig. 1A; programmer device 380 pictured as a smart phone/tablet, [0058]; the programmer 380 is operated manually by the patient of a caregiver).
Regarding claim 22, Simon in view of Dayan teaches the method of claim 19. Simon is silent regarding wherein the neurostimulator is delivered to a selected site with a delivery device having a steerable tip wherein said delivery device is at least one of a needle or a guidewire.
Dayan teaches wherein said delivery device is at least one of a needle or a guidewire (see Dayan Dayan [0239-0243]; distal end 33 of steerable delivery guide 34 is configured to puncture oral mucosa of the subject)
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 Simon’s delivery device for delivery of a neurostimulator with Dayan’s needly delivery device comprising a steerable tip and. One of ordinary skill in the art would have been motivated to make this modification in order to position the neural stimulator at the selected site in a minimally invasive manner by passing through the palate without requiring a prior surgical incision (Dayan [0239-0243]).
Regarding claim 23, Simon in view of Dayan teaches the method of claim 19 further comprising stabilizing the remote transducer near the neurostimulator and outside the body of the subject using a band configured to extend around the head of the subject (see Simon [0058]; the controller 370 is preferably both portable and rechargeable, in one embodiment, it may be worn around the neck as a pendant, placed in a pocket, or clipped to clothing).
It can be appreciated that under its broadest reasonable interpretation, the claim limitation of ‘a band configured to extend around the head of the subject’ is met by the band of a pendant because the band must necessarily extend around the head of the subject in order for a pendant to be worn in a resting position around the neck.
Regarding claim 24, Simon in view of Dayan teaches the method of claim 19, further comprising operating the remote transducer to power the neurostimulator by using one or more of the remote transducer itself, a remote control device, or a smartphone (see Simon [0093]; the external transmitting antenna, which serves as the source of the stimulator's power and stimulation waveform, is preferably suited within a handheld device that may be played near, and pointed towards the patient's nose, whenever it is desired to stimulate the SPG, the handheld device served to control operation of the stimulator and might resemble a typical remote control device or a smartphone).
Regarding claim 25, Simon in view of Dayan teaches the method of claim 19, further comprising stabilizing the remote transducer near the neurostimulator and outside the body of the subject using a hand of the subject (see Simon [0093]; the external transmitting antenna, which serves as the source of the stimulator's power and stimulation waveform, is preferably suited within a handheld device that may be played near, and pointed towards the patient's nose, whenever it is desired to stimulate the SPG, the handheld device served to control operation of the stimulator and might resemble a typical remote control device or a smartphone).
Regarding claim 26, Simon in view of Dayan teaches the method of claim 19, wherein said applying the electrical stimulation at least one of excites or inhibits parasympathetic activity of the SPG through the greater petrosal nerve (see Simon [0016-0017]; the device uses electrical stimulation to reversibly inhibit or block activity of the SPG or other branches of cranial nerves), and/or at least one of excites or inhibits sympathetic activity of the SPG through the deep petrosal nerve (see Simon [0005]; the SPG conveys sensory and sympathetic fibers and is innervated by the greater petrosal nerve).
Regarding claim 27, Simon in view of Dayan teaches the method of claim 19, wherein said applying the electrical stimulation reversibly stimulates the SPG of the subject and overrides the SPG of the subject to restore normal neuronal activity (see Simon [0016-0017]; the device uses electrical stimulation to reversibly inhibit or block activity of the SPG or other branches of cranial nerves, the stimulation may be used to treat any condition that has been treated by anesthetic blockage of the SPG, particularly cluster headache).
Regarding claim 28, Simon teaches a system for treating vascular spasm of a subject comprising:
a neurostimulator (300) comprising an implant body and a lead having at least one electrode (see Figs. 1A-1C, [0058-0059]; nerve modulating device 300 also known as an implantable lead having one or more electrodes 340)
the neurostimulator configured to be implanted in the subject with the delivery device such that the at least one electrode is positioned proximate a sphenopalatine ganglion (SPG) of the subject (see [0046-0047]; the electrode lead(s) are delivered through one or both nostrils of the patient to the nasopharyngeal mucosa posterior to the middle turbinate adjacent to the SPG); and
a remote transducer (370) in electrical communication with the neurostimulator and configured to wirelessly power the neurostimulator (see [0058-0059]; the external controller 370 supplies power and control of implanted device 300 and is preferably both portable and rechargeable),
wherein the neurostimulator is configured to apply electrical stimulation to at least one of excite or inhibit the SPG of the subject (see [0076]; the electrode and signal generator are primarily intended for stimulation of the SPG, [0046]; electrical waveforms for use with the stimulator may be used to preferentially block or otherwise modulate the activity of particular nerves in and around the SPG); and
wherein the electrical stimulation applied by the neurostimulator to the SPG of the subject is configured to selectively change frequency of a waveform to modulate the activity of the SPG of the subject to control vascular spasm in the subject (see [0061-0063]; modulating the stimulation power to the nerve by altering the number and timing of the pulses).
Simon is silent regarding wherein the neurostimulator is delivered to a selected site via a delivery device having a steerable tip.
Dayan teaches an implant and delivery system for a neural stimulator, wherein the neural stimulator (32) is delivered to a selected site in the subject in a minimally invasive manner with a delivery device (34) having a steerable tip (see Dayan [0241]; neural stimulator implant 32 is coupled to steerable delivery guide 34 such that both the implant and the guide 34 are advanced through the greater palatine foramen into the greater palatine canal and implant 32 is brought into a vicinity of a sphenopalatine ganglion, steerable guide 34 is retracted after the placement of implant 32, [0247]; slide bar 57 provides steering functionality for facilitating advancement of guide 34).
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 Simon’s method for delivering a neurostimulator to a selected site using a delivery device with Dayan’s steerable delivery device. One of ordinary skill in the art would have been motivated to make this modification because typically, the greater palatine canal is curved and has multiple naturally formed openings, so proper steering of the delivery device allows for the neurostimulator to be implanted at the desired site proximate a sphenopalatine ganglion (Dayan [0249]).
Regarding claim 29, Simon in view of Dayan teaches the system of claim 28, further comprising a personal electronic device (380) in electrical communication with the remote transducer (370) and configured to wirelessly receive data related at least to the electrical stimulation applied to the SPG of the subject (see Simon [0108]; circuitry of a processor in the implanted signal generator that couple communicate a signal back to the power/control unit, this signal could contain status information such as voltage, current, number of pulses applied, or other applicable data, [0027]; the system may also comprise a docking station wherein the docking station and stimulation device may also transmit data to one another wirelessly).
Regarding claim 30, Simon in view of Dayan teaches the system of claim 29, wherein the personal electronic device comprises one or more of a smart phone, tablet, or personal computer (see Simon Fig. 1A; programmer device 380 pictured as a smart phone/tablet, [0058]; the programmer 380 is operated manually by the patient of a caregiver).
Regarding claim 31, Simon in view of Dayan teaches the system of claim 28. Simon is silent regarding wherein the neurostimulator is delivered to a selected site with a delivery device having a steerable tip wherein said delivery device is at least one of a needle or a guidewire.
Dayan teaches wherein said delivery device is at least one of a needle or a guidewire having a steerable tip configured to deliver the neurostimulator in a minimally invasive manner to a selected location in the body of the subject (see Dayan [0239-0243]; distal end 33 of steerable delivery guide 34 is configured to puncture oral mucosa of the subject to be positioned at the desired location).
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 Simon’s delivery device for delivery of a neurostimulator with Dayan’s needly delivery device comprising a steerable tip and. One of ordinary skill in the art would have been motivated to make this modification in order to position the neural stimulator at the selected site in a minimally invasive manner by passing through the palate without requiring a prior surgical incision (Dayan [0239-0243]).
Regarding claim 32, Simon in view of Dayan teaches the system of claim 28 wherein the remote transducer is configured to be stabilized near the neurostimulator and outside the body of the subject using a band configured to extend around the head of the subject (see Simon [0058]; the controller 370 is preferably both portable and rechargeable, in one embodiment, it may be worn around the neck as a pendant, placed in a pocket, or clipped to clothing).
It can be appreciated that under its broadest reasonable interpretation, the claim limitation of ‘a band configured to extend around the head of the subject’ is met by the band of a pendant because the band must necessarily extend around the head of the subject in order for a pendant to be worn in a resting position around the neck.
Regarding claim 33, Simon in view of Dayan teaches the system of claim 28, wherein the remote transducer is configured to be operated by at least one of the remote transducer itself, a remote control device, or a smartphone (see Simon [0093]; the external transmitting antenna, which serves as the source of the stimulator's power and stimulation waveform, is preferably suited within a handheld device that may be played near, and pointed towards the patient's nose, whenever it is desired to stimulate the SPG, the handheld device served to control operation of the stimulator and might resemble a typical remote control device or a smartphone).
Regarding claim 34, Simon in view of Dayan teaches the system of claim 28, wherein the remote transducer is configured to be stabilized near the neurostimulator and outside the body of the subject with the hand of the subject (see Simon [0093]; the external transmitting antenna, which serves as the source of the stimulator's power and stimulation waveform, is preferably suited within a handheld device that may be played near, and pointed towards the patient's nose, whenever it is desired to stimulate the SPG, the handheld device served to control operation of the stimulator and might resemble a typical remote control device or a smartphone).
Regarding claim 35, Simon in view of Dayan teaches the system of claim 28, wherein the neurostimulator at least one of excites or inhibits parasympathetic activity of the SPG through the greater petrosal nerve (see Simon [0016-0017]; the device uses electrical stimulation to reversibly inhibit or block activity of the SPG or other branches of cranial nerves), and/or at least one of excites or inhibits sympathetic activity of the SPG through the deep petrosal nerve (see Simon [0005]; the SPG conveys sensory and sympathetic fibers and is innervated by the greater petrosal nerve).
Regarding claim 36, Simon in view of Dayan teaches the system of claim 28, wherein the system is configured to selectively apply electrical stimulation via the neurostimulator to reversibly stimulate the SPG of the subject and override the SPG of the subject to restore normal neuronal activity (see Simon [0016-0017]; the device uses electrical stimulation to reversibly inhibit or block activity of the SPG or other branches of cranial nerves, the stimulation may be used to treat any condition that has been treated by anesthetic blockage of the SPG, particularly cluster headache).
Regarding claim 37, Simon teaches a method of treating vascular spasm of a subject comprising:
inserting a neurostimulator (300) comprising an implant body and a lead having at least one electrode (see Figs. 1A-1C, [0058-0059]; nerve modulating device 300 also known as an implantable lead having one or more electrodes 340)
to a selected site proximate a sphenopalatine ganglion (SPG) of the subject (see [0046-0047]; the electrode lead(s) are delivered through one or both nostrils of the patient to the nasopharyngeal mucosa posterior to the middle turbinate adjacent to the SPG);
powering the neurostimulator wirelessly with a remote transducer (370) that is in electrical communication with the neurostimulator (see [0058-0059]; the external controller 370 supplies power and control of implanted device 300 and is preferably both portable and rechargeable),
applying electrical stimulation with the neurostimulator (300) to at least one of excite or inhibit the SPG of the subject (see [0076]; the electrode and signal generator are primarily intended for stimulation of the SPG, [0046]; electrical waveforms for use with the stimulator may be used to preferentially block or otherwise modulate the activity of particular nerves in and around the SPG); and
modulating the activity of the SPG of the subject by the electrical stimulation applied by the neurostimulator to control vascular spasm in the subject (see [0061-0063]; modulating the stimulation power to the nerve by altering the number and timing of the pulses).
Simon is silent regarding inserting a neurostimulator comprising an implant body and a lead having at least one electrode into a needle having a steerable tip;
navigating the steerable tip of the needle in a minimally invasive manner through the subject's anatomy to a selected site proximate a sphenopalatine ganglion (SPG) of the subject; and
injecting the neurostimulator through the steerable tip of the needle and into the subject at a selected site.
Dayan teaches an implant and delivery system for a neural stimulator, comprising
inserting a neurostimulator (32) into a needle having a steerable tip (34);
navigating the steerable tip of the needle in a minimally invasive manner through the subject's anatomy to a selected site proximate a sphenopalatine ganglion (SPG) of the subject (see Dayan [0239-0243]; neural stimulator implant 32 is coupled to steerable delivery guide 34 and both implant and guide are advanced through the greater palatine foramen into the greater palatine canal to bring the neuro stimulator implant into a vicinity of a sphenopalatine ganglion; the delivery guide is steered in the canal in order to deliver the neural stimulator implant to the SPG.); and
injecting the neurostimulator through the steerable tip of the needle and into the subject at a selected site (see Dayan [0239-0243]; neuro stimulator implant 32 is passed through guide 34 to advance through the greater palatine foramen into the greater palatine canal to bring the neuro stimulator implant into a vicinity of a sphenopalatine ganglion, steerable delivery guide 34 is retracted after placement of implant 32).
wherein the neural stimulator (32) is delivered to a selected site in the subject in a minimally invasive manner with a delivery device (34) having a steerable tip (see Dayan [0241]; neural stimulator implant 32 is coupled to steerable delivery guide 34 such that both the implant and the guide 34 are advanced through the greater palatine foramen into the greater palatine canal and implant 32 is brought into a vicinity of a sphenopalatine ganglion, steerable guide 34 is retracted after the placement of implant 32, [0247]; slide bar 57 provides steering functionality for facilitating advancement of guide 34).
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 Simon’s method for delivering a neurostimulator to a selected site using a delivery device with Dayan’s steerable delivery device. One of ordinary skill in the art would have been motivated to make this modification because typically, the greater palatine canal is curved and has multiple naturally formed openings, so proper steering of the delivery device allows for the neurostimulator to be implanted at the desired site proximate a sphenopalatine ganglion (Dayan [0249]).
Regarding claim 38, Simon in view of Dayan teaches the method of claim 37, wherein the electrical stimulation applied by the neurostimulator is configured to reversibly stimulate the SPG of the subject and override the SPG of the subject to restore normal neuronal activity (see Simon [0016-0017]; the device uses electrical stimulation to reversibly inhibit or block activity of the SPG or other branches of cranial nerves, the stimulation may be used to treat any condition that has been treated by anesthetic blockage of the SPG, particularly cluster headache).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lamensdorf et al (US 20150174406 A1) which teaches a method for SPG stimulation.
Yakovlev et al (US 20170095667 A1) which teaches a method and apparatus for neuromodulation treatments of pain and other conditions.
Perryman et al (US 20160038741 A1) which teaches devices and methods for treating craniofacial pain.
Boling et al (US 9456836 B2) which teaches an apparatus and method for delivering a neurostimulator into the pterygopalatine fossa.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
