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 .
DETAILED ACTION
Acknowledgement is made of applicant’s amendment which was received by the office on May 26, 2026. Claims 25-26, 28-45 are currently pending.
Specification
In view of the amendment filed on 5/26/2026 clarifying the language within para. [0001] of the specification the objections made against the specification in the office action of 2/25/206 have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 28-29, 41 and 43-44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 28-29 directly or indirectly depend from claim 27 which has been canceled, therefore the metes and bounds of claims 28-29 is indefinite, clarification is required. For the purposes of examination, as best understood, claims 28-29 have been interpreted to depend from claim 25. Claims 41 and 43-44 recite a pupil diameter (claim 41,44), a skin temperature (claim 43-44), and perspiration rate/perspiration density (claims 43-44) being measured by the sensor, however claim 39 from which claims 41 and 43-44 depend has been amended to recite that the sensor measures a blood circulation velocity, therefore claims 41 and 43-44 appear to be broadening the scope rather than further limiting the scope of claim 39, clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 25-26 and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0310070 to Sabesan (Sabesan) (previously cited0.
In reference to at least claim 25
Sabesan discloses a system comprising: an esophageal catheter including at least one electrode (e.g. cuff electrode 40); a sensor (e.g. “at least one EEG sensor”, para. [0005]; “one or more sensors 230”, para. [0065]); and a controller in communication with the at least one electrode and the sensor (e.g. processing circuit 252); wherein, upon receiving a signal from the sensor (e.g. “The sensors 230 may be configured to acquire response data of a patient having a seizure to facilitate monitoring a physiological response of the patient to VNS therapy during a seizure.”, para. [0068]), the controller induces the electrode to transmit a recruiting signal that recruits a cervical ganglion (e.g. “The stimulation analyzer 262 may be configured to receive response data acquired by the sensors 230 indicative of a physiological response of the patient to the stimulation of the vagus nerve….In another embodiment, the efficacy/severity analyzer 264 may provide information to the stimulation manager 260 or the stimulation analyzer 262 in order to modify parameters of the stimulation based on the efficacy of VNS therapy in reducing seizure severity.”, para. [0076]), wherein the signal received by the controller, from the sensor, includes a first EEG measurement comprising a first spectral edge frequency, a first beta to theta ratio, a first median frequency, a first beta to delta ratio, or a combination thereof (e.g. “first EEG synchronization of the seizure condition of the patient by extracting first maximum wavelet coefficients in a first plurality of epochs and a plurality of frequency bands for a plurality of EEG sensors”, para. [0006]).
In reference to at least claim 26
Sabesan discloses wherein the sensor includes one or more electroencephalogram electrodes (e.g. “at least one EEG sensor”, para. [0005]).
In reference to at least claim 28
Sabesan discloses wherein the controller is configured to compare the first EEG measurement to a second EEG measurement, a reference value, or a reference range (e.g. “The method further includes generating an indication of an efficacy of the stimulation to the vagus nerve using at least one of the second synchronizability index or a comparison of the second synchronizability index to the first synchronizability index.”, para. [0006], “These measurements may be used separately or in conjunction with one another to determine efficacy or severity of a seizure. This information can be compared for an individual before and after receiving automatic VNS”, para. [0043], [0050], “The one or more response features may be predefined within the efficacy/severity analyzer 264 and/or manually input by an operator of the VNS analysis system 200. The response features may be compared to thresholds, or other response features associated with the patient”, para. [0072]).
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.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0310070 to Sabesan (Sabesan) in view of US 2008/0269840 to Scott (Scott) (previously cited).
In reference to at least claim 29
Sabesan teaches a system according to claim 28 and further the controller induces the electrode to transmit a recruiting signal that recruits a cervical ganglion (e.g. “The stimulation analyzer 262 may be configured to receive response data acquired by the sensors 230 indicative of a physiological response of the patient to the stimulation of the vagus nerve….In another embodiment, the efficacy/severity analyzer 264 may provide information to the stimulation manager 260 or the stimulation analyzer 262 in order to modify parameters of the stimulation based on the efficacy of VNS therapy in reducing seizure severity.”, para. [0076]) and adjusting the delivery of the therapy based on the sensed data (e.g. “These features may be used to manage and/or adjust the automated delivery of VNS Therapy to a patient based on seizure detection, and may further be used to configure therapy to evaluate and reduce seizure severity.”, para. [0131]).
However, Sabesan does not explicitly teach the recruiting signal includes a frequency and an amplitude, and the controller is configured to adjust the frequency and/or the amplitude of the recruiting signal, based on the comparison. It was well known in the art for a signal to include a frequency and an amplitude and adjust a frequency and/or an amplitude of the signal based on sensed data as evidence by Scott (e.g. “programming parameters to define the therapeutic electrical signal (e.g., on-time, off-time, pulse width, current amplitude, frequency) into the IMD 100 to alter its operation as desired.”, para. [0072], “ the electrical signal may be varied in a number of ways known in the art using a number of different parameters of the signal such as without limitation, pulse width, current amplitude, frequency, on-off time, duty cycle, number of pulses per burst, interburst period, interpulse interval, burst duration, or combinations thereof. In general, these parameters may be adjusted through the programming system 120.”, para. [0085]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sabesan to include the recruiting signal including a frequency and an amplitude, and the controller being configured to adjust the frequency and/or the amplitude of the recruiting signal, based on the comparison as such technique was well known in the art and would have provided the predictable result of altering the operation of the signal to provide the desired response for the patient while avoiding or minimizing undesired side effects associated with nerve stimulation (‘840, para. [0009], [0086]).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0310070 to Sabesan (Sabesan) in view of US 2010/0240971 to Zanatta (Zanatta) (previously cited).
In reference to at least claim 30
Sabesan teaches a system according to claim 25 and further discloses a sensor (e.g. “at least one EEG sensor”, para. [0005]; “one or more sensors 230”, para. [0065]);
Sabesan does not explicitly teach the sensor measuring being configured to measure a blood circulation velocity in a blood vessel in a brain.
Zanatta, in the same field, discloses using at least one blood flow velocity sensor for sensing blood flow velocity of a patient (e.g. abstract, “At least one brain blood flow velocity sensor is configured to sense a brain blood flow velocity of the patient”, para. [0013]-[0014], [0021]) for early detection of brain ischemia (e.g. para. [0006]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sabesan to include a sensor for measuring a blood circulation velocity, as taught by Zanatta, to provide early detection of brain ischemia (‘971, para. [0006], [0009]).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0310070 to Sabesan (Sabesan) in view of US 2010/0042193 to Slavin (Slavin) (previously cited).
In reference to at least claim 31
Sabesan teaches a system according to claim 25 but does not explicitly teach recruiting the cervical ganglion includes blocking transmission of nerve signals along the cervical ganglion.
Slavin discloses a system comprising: an esophageal catheter including an electrode (e.g. para. [0042]); a sensor (e.g. “ assessing whether the subject has a presence of a cerebral vasospasm or an absence of a cerebral vasospasm”, para. [0018], therefore some form of sensor is present); and a controller in communication with the at least one electrode and the sensor (e.g. para. [0035]); wherein, upon receiving a first signal from the sensor (e.g. “electrical impulse generator 32 is activated to deliver the desired electrical signal to only the first group of contacts based on the presence of cerebral vasospasm and activating the electrical impulse generator 32 to deliver the electrical signal to only the second group of contacts based on the absence of cerebral vasospasm.”, para. [0039]), the controller induces the electrode to transmit a recruiting signal that recruits a cervical ganglion (e.g. para. [0051], [0054]-[0055]), where the recruiting signal is pulsed, and has a frequency of 100 Hz to 100 kHz and an amplitude of 10 µA to 20 mA (e.g. “As used herein "effective amount" is variable among subjects but generally corresponds within a rate range of approximately 2 to 1000 pulses per second, a pulse width range of approximately 10 to 500 milliseconds, an amplitude range of approximately up to 10 volts, and electrode polarity set in monopolar, bipolar, tripolar or more complex pattern.”, para. [0019]), wherein recruiting the cervical ganglion includes blocking transmission of nerve signals along the cervical ganglion (e.g. “performed cervical sympathetic blockade to treat nine patients with clinical cerebral vasospasm confirmed by angiography. They observed improvement in cerebral perfusion in all angiograms after the blockade,”, para. [0055]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sabesan to include the recruiting the cervical ganglion including blocking transmission of nerve signals along the cervical ganglion, as taught by Slavin, in order to treat vasospasm improving cerebral perfusion (‘193, para. [0055]).
Claim(s) 32-36 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0042193 to Slavin (Slavin) in view of US 2008/0269840 to Scott (Scott) (previously cited).
In reference to at least claim 32
Slavin discloses a system comprising: an esophageal catheter including an electrode (e.g. para. [0042]); a sensor (e.g. “ assessing whether the subject has a presence of a cerebral vasospasm or an absence of a cerebral vasospasm”, para. [0018], therefore some form of sensor is present); and a controller in communication with the at least one electrode and the sensor (e.g. para. [0035]); wherein, upon receiving a first signal from the sensor (e.g. “electrical impulse generator 32 is activated to deliver the desired electrical signal to only the first group of contacts based on the presence of cerebral vasospasm and activating the electrical impulse generator 32 to deliver the electrical signal to only the second group of contacts based on the absence of cerebral vasospasm.”, para. [0039]), the controller induces the electrode to transmit a recruiting signal that recruits a cervical ganglion (e.g. para. [0051], [0054]-[0055]), where the recruiting signal is pulsed, and has a frequency of 100 Hz to 100 kHz and an amplitude of 10 µA to 20 mA (e.g. “As used herein "effective amount" is variable among subjects but generally corresponds within a rate range of approximately 2 to 1000 pulses per second, a pulse width range of approximately 10 to 500 milliseconds, an amplitude range of approximately up to 10 volts, and electrode polarity set in monopolar, bipolar, tripolar or more complex pattern.”, para. [0019]), wherein recruiting the cervical ganglion includes blocking transmission of nerve signals along the cervical ganglion (e.g. “performed cervical sympathetic blockade to treat nine patients with clinical cerebral vasospasm confirmed by angiography. They observed improvement in cerebral perfusion in all angiograms after the blockade,”, para. [0055]).
Slavin discloses upon receiving a second signal from the sensor, or the user, the controller induces the electrode to adjust the recruiting signal (e.g. “electrical impulse generator 32 is activated to deliver the desired electrical signal to only the first group of contacts based on the presence of cerebral vasospasm and activating the electrical impulse generator 32 to deliver the electrical signal to only the second group of contacts based on the absence of cerebral vasospasm.”, para. [0039], “The controller 38 may also be used to control or monitor the level or duration of spinal stimulation that occurs.”, para. [0045]).
However, Slavin does not explicitly teach the adjusting of the recruiting signal being adjusting the frequency of the recruiting signal, the amplitude of the recruiting signal, or both. It was well known in the art for a signal to include a frequency and an amplitude and adjusting a frequency and/or an amplitude of the signal based on sensed data as evidence by Scott (e.g. “programming parameters to define the therapeutic electrical signal (e.g., on-time, off-time, pulse width, current amplitude, frequency) into the IMD 100 to alter its operation as desired.”, para. [0072], “ the electrical signal may be varied in a number of ways known in the art using a number of different parameters of the signal such as without limitation, pulse width, current amplitude, frequency, on-off time, duty cycle, number of pulses per burst, interburst period, interpulse interval, burst duration, or combinations thereof. In general, these parameters may be adjusted through the programming system 120.”, para. [0085]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Slavin to include adjusting the frequency of the recruiting signal, the amplitude of the recruiting signal, or both as such technique was well known in the art and would have provided the predictable result of altering the operation of the signal to provide the desired response for the patient while avoiding or minimizing undesired side effects associated with nerve stimulation (‘840, para. [0009], [0086]).
In reference to at least claim 33
Slavin discloses wherein the electrode is a first electrode positioned on a surface of the catheter, and the catheter further comprises a second electrode opposite the first electrode, where the first electrode and second electrode are positioned at a same axial level of the catheter (e.g. “ In another embodiment, the implantable electrode portion 36 is implanted in the cervical spinal region at the C3-C5 level. In some embodiments, the implantable electrode portion 36 comprises a single contact so that electrical stimulation can be carried out on one specific area (or contact point) of the spinal cord. In some embodiments, the implantable electrode portion comprises multiple contacts (36a-36j) so that electrical stimulation can be carried out on more than one area (or contact points) of the spinal cord simultaneously or sequentially.”, para. [0039]).
In reference to at least claim 34
Slavin discloses wherein the first electrode is on a first side of a lateral axis bisecting the catheter, and the second electrode is on a second side of the lateral axis bisecting the catheter (e.g. “In some embodiments, the implantable electrode portion comprises multiple contacts (36a-36j) so that electrical stimulation can be carried out on more than one area (or contact points) of the spinal cord simultaneously or sequentially.”, para. [0039], multiple contacts are present including a first electrode on a first side of a lateral axis bisecting the catheter, and a second electrode on a second side of the lateral axis bisecting the catheter).
In reference to at least claim 35
Slavin discloses wherein the catheter includes an intermediate section operable to radially expand from a contracted state to an expanded state, and wherein the first electrode and the second electrode are disposed within the intermediate section of the catheter (e.g. “The implantable electrode portion 36 may be any suitable electrode including: intravascular, transcutaneous, intracutaneous, patch-type, cuff-type, tape-type, screw-type, barb-type, metal, wire, balloon-type, basket-type, umbrella-type or suction-type electrodes.”, para. [0036], “Nerve stimulation implantable electrodes 46 may be endotracheal, endoesophageal, intravascular, transcutaneous, intracutaneous, patch-type, balloon-type, cuff-type, basket-type, umbrella-type, tape-type, screw-type, barb-type, metal, wire or suction-type electrodes. “, para. [0042], the electrode portion and nerve stimulation implantable electrodes can include a ballon-type, basket-type, umbrella-type which would inherently include a section that is operable to radially expand from a contracted state to an expanded state.).
In reference to at least claim 36
Slavin discloses wherein, when the intermediate section of the catheter is in the expanded state, the first electrode is farther displaced from the second electrode, as compared to when the intermediate section of the catheter is in the contracted state (e.g. “The implantable electrode portion 36 may be any suitable electrode including: intravascular, transcutaneous, intracutaneous, patch-type, cuff-type, tape-type, screw-type, barb-type, metal, wire, balloon-type, basket-type, umbrella-type or suction-type electrodes.”, para. [0036], “Nerve stimulation implantable electrodes 46 may be endotracheal, endoesophageal, intravascular, transcutaneous, intracutaneous, patch-type, balloon-type, cuff-type, basket-type, umbrella-type, tape-type, screw-type, barb-type, metal, wire or suction-type electrodes….The catheter may comprise, for example, a balloon which may be inflated with air or liquid to press the electrodes firmly against the vessel wall.”, para. [0042], the electrode portion and nerve stimulation implantable electrodes can include a ballon-type, basket-type, umbrella-type which includes a ballon that is inflated to press the electrode against the vessel wall.).
In reference to at least claim 45
Slavin discloses upon receiving a second signal from the sensor, or the user, the controller induces the electrode to adjust the recruiting signal (e.g. “electrical impulse generator 32 is activated to deliver the desired electrical signal to only the first group of contacts based on the presence of cerebral vasospasm and activating the electrical impulse generator 32 to deliver the electrical signal to only the second group of contacts based on the absence of cerebral vasospasm.”, para. [0039], “The controller 38 may also be used to control or monitor the level or duration of spinal stimulation that occurs.”, para. [0045]). It was well known in the art for a signal to include a frequency and an amplitude and adjusting a frequency and/or an amplitude of the signal based on sensed data as evidence by Scott (e.g. “programming parameters to define the therapeutic electrical signal (e.g., on-time, off-time, pulse width, current amplitude, frequency) into the IMD 100 to alter its operation as desired.”, para. [0072], “ the electrical signal may be varied in a number of ways known in the art using a number of different parameters of the signal such as without limitation, pulse width, current amplitude, frequency, on-off time, duty cycle, number of pulses per burst, interburst period, interpulse interval, burst duration, or combinations thereof. In general, these parameters may be adjusted through the programming system 120.”, para. [0085]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Slavin to include comparing the sensed data and adjusting the frequency of the recruiting signal, the amplitude of the recruiting signal, or both as such technique was well known in the art and would have provided the predictable result of altering the operation of the signal to provide the desired response for the patient while avoiding or minimizing undesired side effects associated with nerve stimulation (‘840, para. [0009], [0086]).
Claim(s) 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0042193 to Slavin (Slavin) in view of US 2008/0269840 to Scott (Scott) as applied to claim 32 further in view of US Patent No. 9,999,767 to Tal et al. (Tal) (previously cited).
In reference to at least claim 37
Slavin as evidence by Scott renders obvious a system according to claim 32. Slavin does not explicitly teach wherein the catheter further includes a feeding tube.
Tal, in the same field of stimulation, discloses an esophageal catheter (e.g. 11) with a sensor (e.g. 650) in which the catheter includes a feeding tube (Col 4, lines 32-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Slavin to include the catheter including a feeding tube, as taught by Tal, in order to stimulate a series of portions of the esophagus along an esophageal length to treat peristaltic motility (Col 5, lines 58-60).
In reference to at least claim 38
Slavin as evidence by Scott and modified by Tal renders obvious a system according to claim 37. The modified device of Slavin with Scott and Tal discloses a feeding tube being within an esophagus of a subject, therefore Slavin as evidence by Scott and modified by Tal discloses wherein the system is configured such that while at least a portion of the feeding tube is in an esophagus of a subject the electrode is within an oroesophageal cavity of the subject (e.g. “Nerve stimulation implantable electrodes 46 may be endotracheal, endoesophageal… Similar techniques may be performed by insertion of a catheter-type device into the trachea or esophagus. Additionally, tracheal tubes and esophageal tubes comprising electrodes may be used.”, para. [0042]).
Claim(s) 39 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0042193 to Slavin (Slavin) in view of US 2010/0240971 to Zanatta (Zanatta).
In reference to at least claim 39
Slavin discloses a system comprising: an esophageal catheter including an electrode (e.g. para. [0042]); a sensor (e.g. “assessing whether the subject has a presence of a cerebral vasospasm or an absence of a cerebral vasospasm”, para. [0018], therefore some form of sensor is present); and a controller in communication with the electrode and the sensor (e.g. para. [0035]); wherein, upon receiving a signal from the sensor (e.g. “electrical impulse generator 32 is activated to deliver the desired electrical signal to only the first group of contacts based on the presence of cerebral vasospasm and activating the electrical impulse generator 32 to deliver the electrical signal to only the second group of contacts based on the absence of cerebral vasospasm.”, para. [0039]), the controller induces the electrode to transmit a recruiting signal that recruits a cervical ganglion (e.g. para. [0051], [0054]-[0055]).
Slavin discloses a sensor (e.g. " assessing whether the subject has a presence of a cerebral vasospasm or an absence of a cerebral vasospasm", para. [0018], therefore some form of sensor is present). However, Slavin does not explicitly teach the sensor measuring a blood circulation velocity in a blood vessel in a brain.
Zanatta, in the same field, discloses using at least one blood flow velocity sensor for sensing blood flow velocity of a patient (e.g. abstract, “At least one brain blood flow velocity sensor is configured to sense a brain blood flow velocity of the patient”, para. [0013]-[0014], [0021]) for early detection of brain ischemia (e.g. para. [0006]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Slavin to include a sensor for measuring a blood circulation velocity, as taught by Zanatta, to provide early detection of brain ischemia (‘971, para. [0006], [0009]).
In reference to at least claim 42
Slavin modified by Zanatta renders obvious a system according to claim 39. Zanatta further discloses using at least one blood flow velocity sensor for sensing blood flow velocity of a patient (e.g. abstract, “At least one brain blood flow velocity sensor is configured to sense a brain blood flow velocity of the patient”, para. [0013]-[0014], [0021]) for early detection of brain ischemia (e.g. para. [0006]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Slavin to include a sensor for measuring a blood circulation velocity including first and second blood circulation velocities, as taught by Zanatta, to provide early detection of brain ischemia (‘164, para. [0006], [0009]).
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0042193 to Slavin (Slavin) in view of US 2010/0240971 to Zanatta (Zanatta) as applied to claim 39 further in view of US 2008/0051838 to Shuros et al. (Shuros).
In reference to at least claim 40
Slavin modified by Zanatta renders obvious a system according to claim 39.
However, Slavin modified by Zanatta does not disclose the sensor including an infrared monitoring device. It was well known in the art to use an infrared sensor for measuring the velocity of the blood flow as evidence by Shuros (e.g. para. [0042]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Slavin to include utilizing an infrared monitoring device for measuring the velocity of the blood flow as such technique was well known in the art and would have provided the predictable result of providing a non-contact method for measuring blood flow velocity.
Claim(s) 41 and 43-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0042193 to Slavin (Slavin) in view of US 2010/0240971 to Zanatta (Zanatta ) as applied to claim 39 further in view of US 2006/0111754 to Rezai et al. (Rezai) (previously cited).
In reference to at least claim 41
Slavin modified by Zanatta renders obvious a system according to claim 39. Slavin discloses a sensor (e.g. " assessing whether the subject has a presence of a cerebral vasospasm or an absence of a cerebral vasospasm", para. [0018], therefore some form of sensor is present).
Slavin does not explicitly teach the sensor measuring a pupil diameter, wherein the controller is configured to compare a first pupil diameter measured by the sensor to a second pupil diameter measured by the sensor, and based on the comparison, adjust an amplitude or a frequency of the recruiting signal.
Rezai, in the same field of neuromodulation, discloses a system that includes providing stimulation to a target site that include the cervical spinal ganglia (e.g. claim 10) which discloses using a closed-loop feedback mechanism that includes a sensor. The system includes a controller that adjust a therapy signal to a target site in response to a sensor signal (e.g. “ The system also includes a controller in communication with the therapy delivery device for activating the therapy delivery device to initiate application of the therapy signal to the target site or to adjust application of the therapy signal to the target site in response to the sensor signal.”, para. [0047]). The sensor signal can include a pupil diameter (e.g. sensing performed includes a “flicker pupillary response”, para. [0067], table 1) a skin temperature, a perspiration rate or a perspiration density (e.g. “The bodily activity to be detected by the sensor is any characteristic or function of the body, such as electrical or chemical activity and includes, for example, temperature, respiratory function, heart rate, capillary pressure, venous pressure, perfusion, oxygenation including blood oxygenation levels, oxygen saturation levels, oxygen consumption, oxygen pressure, water pressure, nitrogen pressure, carbon dioxide pressure in the tissue, circulation (including blood and lymphatic), electrolyte levels in the circulation/tissue, diffusion or metabolism of various agents and molecules (such as glucose), neurotransmitter levels, body temperature regulation, blood pressure, blood viscosity, metabolic activity, cerebral blood flow, pH levels, vital signs, galvanic skin responses, perspiration, electrocardiogram, electroencephalogram, action”, para. [0047]). Rezai discloses that the method minimizes or resolves side effects and morbidity associated with therapies (e.g. para. [0021], [0059]). Rezai further discloses wherein the controller is configured to compare a first pupil diameter measured by the sensor to a second pupil diameter measured by the sensor, and based on the comparison (e.g. “Microprocessor 76 processes the sensor data in different ways depending on the type of transducer in use. When the signal on the sensor indicates biological activity outside of threshold values,”, para. [0053]-[0054], the first measurement being a predetermined measurement using the sensor and the sensor data includes flicker pupillary response), adjust an amplitude or a frequency of the recruiting signal (e.g. “The output voltage or current from the controller are then generated in an appropriately configured form (voltage, current, frequency), and applied to the one or more therapeutic delivery devices placed at the target site for a prescribed time period”, para. [0053]-[0054]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Slavin modified by Zanatta to include a sensor for measuring a pupil diameter and the controller being configured to compare a first pupil diameter measured by the sensor to a second pupil diameter measured by the sensor, and based on the comparison and adjust an amplitude or a frequency of the recruiting signal, as taught by Rezai, to provide a closed loop feedback that minimizes or resolves side effects and morbidity associated with therapies (‘754, para. [0059]).
In reference to at least claim 43
Slavin modified by Zanatta renders obvious a system according to claim 39. Slavin discloses a sensor (e.g. " assessing whether the subject has a presence of a cerebral vasospasm or an absence of a cerebral vasospasm", para. [0018], therefore some form of sensor is present).
Slavin does not explicitly teach wherein the controller is configured to: compare a first skin temperature measured by the sensor to a second skin temperature measured by the sensor; compare a first perspiration rate measured by the sensor to a second perspiration rate measured by the sensor; or compare a first perspiration density measured by the sensor to a second perspiration density measured by the sensor; and based on the comparison, adjust an amplitude or a frequency of the recruiting signal.
Rezai, in the same field of neuromodulation, discloses a system that includes providing stimulation to a target site that include the cervical spinal ganglia (e.g. claim 10) which discloses using a closed-loop feedback mechanism that includes a sensor. The system includes a controller that adjust a therapy signal to a target site in response to a sensor signal (e.g. “ The system also includes a controller in communication with the therapy delivery device for activating the therapy delivery device to initiate application of the therapy signal to the target site or to adjust application of the therapy signal to the target site in response to the sensor signal.”, para. [0047]). The sensor signal can include a pupil diameter (e.g. sensing performed includes a “flicker pupillary response”, para. [0067], table 1) a skin temperature, a perspiration rate or a perspiration density (e.g. “The bodily activity to be detected by the sensor is any characteristic or function of the body, such as electrical or chemical activity and includes, for example, temperature, respiratory function, heart rate, capillary pressure, venous pressure, perfusion, oxygenation including blood oxygenation levels, oxygen saturation levels, oxygen consumption, oxygen pressure, water pressure, nitrogen pressure, carbon dioxide pressure in the tissue, circulation (including blood and lymphatic), electrolyte levels in the circulation/tissue, diffusion or metabolism of various agents and molecules (such as glucose), neurotransmitter levels, body temperature regulation, blood pressure, blood viscosity, metabolic activity, cerebral blood flow, pH levels, vital signs, galvanic skin responses, perspiration, electrocardiogram, electroencephalogram, action”, para. [0047]). Rezai discloses that the method minimizes or resolves side effects and morbidity associated with therapies (e.g. para. [0021], [0059]). Rezai further discloses wherein the controller is configured to: compare a first skin temperature measured by the sensor to a second skin temperature measured by the sensor (e.g. “Microprocessor 76 processes the sensor data in different ways depending on the type of transducer in use. When the signal on the sensor indicates biological activity outside of threshold values,”, para. [0053]-[0054], the first measurement being a predetermined measurement using the sensor and the sensor data includes skin temperature data); compare a first perspiration rate measured by the sensor to a second perspiration rate measured by the sensor (e.g. “Microprocessor 76 processes the sensor data in different ways depending on the type of transducer in use. When the signal on the sensor indicates biological activity outside of threshold values,”, para. [0053]-[0054], the first measurement being a predetermined measurement using the sensor and the sensor data includes perspiration data); or compare a first perspiration density measured by the sensor to a second perspiration density measured by the sensor (e.g. “Microprocessor 76 processes the sensor data in different ways depending on the type of transducer in use. When the signal on the sensor indicates biological activity outside of threshold values,”, para. [0053]-[0054], the first measurement being a predetermined measurement using the sensor and the sensor data includes perspiration data); and based on the comparison, adjust an amplitude or a frequency of the recruiting signal (e.g. “The output voltage or current from the controller are then generated in an appropriately configured form (voltage, current, frequency), and applied to the one or more therapeutic delivery devices placed at the target site for a prescribed time period”, para. [0053]-[0054]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Slavin modified by Zanatta to include a sensor measuring a skin temperature, wherein the controller is configured to compare a first skin temperature measured by the sensor to a second skin temperature measured by the sensor, compare a first perspiration rate measured by the sensor to a second perspiration rate measured by the sensor; or compare a first perspiration density measured by the sensor to a second perspiration density measured by the sensor; and based on the comparison, adjust an amplitude or a frequency of the recruiting signal, as taught by Rezai, to provide a closed loop feedback that minimizes or resolves side effects and morbidity associated with therapies (‘754, para. [0059]).
In reference to at least claim 44
Slavin modified by Zanatta renders obvious a system according to claim 39. Slavin discloses a sensor (e.g. " assessing whether the subject has a presence of a cerebral vasospasm or an absence of a cerebral vasospasm", para. [0018], therefore some form of sensor is present).
Slavin does not explicitly teach the sensor measuring a pupil diameter, wherein the controller is configured to compare a pupil diameter, a blood circulation velocity, a skin temperature, a perspiration rate, or a perspiration density measured by the sensor to a threshold value or a range, and based on the comparison, adjust an amplitude or a frequency of the recruiting signal.
Rezai, in the same field of neuromodulation, discloses a system that includes providing stimulation to a target site that include the cervical spinal ganglia (e.g. claim 10) which discloses using a closed-loop feedback mechanism that includes a sensor. The system includes a controller that adjust a therapy signal to a target site in response to a sensor signal (e.g. “ The system also includes a controller in communication with the therapy delivery device for activating the therapy delivery device to initiate application of the therapy signal to the target site or to adjust application of the therapy signal to the target site in response to the sensor signal.”, para. [0047]). The sensor signal can include a pupil diameter (e.g. sensing performed includes a “flicker pupillary response”, para. [0067], table 1) a skin temperature, a perspiration rate or a perspiration density (e.g. “The bodily activity to be detected by the sensor is any characteristic or function of the body, such as electrical or chemical activity and includes, for example, temperature, respiratory function, heart rate, capillary pressure, venous pressure, perfusion, oxygenation including blood oxygenation levels, oxygen saturation levels, oxygen consumption, oxygen pressure, water pressure, nitrogen pressure, carbon dioxide pressure in the tissue, circulation (including blood and lymphatic), electrolyte levels in the circulation/tissue, diffusion or metabolism of various agents and molecules (such as glucose), neurotransmitter levels, body temperature regulation, blood pressure, blood viscosity, metabolic activity, cerebral blood flow, pH levels, vital signs, galvanic skin responses, perspiration, electrocardiogram, electroencephalogram, action”, para. [0047]). Rezai discloses that the method minimizes or resolves side effects and morbidity associated with therapies (e.g. para. [0021], [0059]). Rezai further discloses wherein the controller is configured to compare a pupil diameter, a blood circulation velocity, a skin temperature, a perspiration rate, or a perspiration density measured by the sensor to a threshold value or a range (e.g. “Microprocessor 76 processes the sensor data in different ways depending on the type of transducer in use. When the signal on the sensor indicates biological activity outside of threshold values,”, para. [0053]-[0054], sensor data includes at least skin temperature and perspiration data), and based on the comparison, adjust an amplitude or a frequency of the recruiting signal (e.g. “The output voltage or current from the controller are then generated in an appropriately configured form (voltage, current, frequency), and applied to the one or more therapeutic delivery devices placed at the target site for a prescribed time period”, para. [0053]-[0054]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Slavin modified by Zanatta to include a sensor for measuring a pupil diameter, skin temperature and/or perspiration and the controller being configured to compare a pupil diameter, skin temperature and/or perspiration to a threshold value or a range, and based on the comparison, adjust an amplitude or a frequency of the recruiting signal., as taught by Rezai, to provide a closed loop feedback that minimizes or resolves side effects and morbidity associated with therapies (‘754, para. [0059]).
Double Patenting
In view of the amendments made to claim 25 to include the subject matter of claim 27 the double patenting rejections made against claims 25 and 31 within the office action of 2/25/2026 have been withdrawn.
Response to Arguments
III. Rejections under 35 USC 102 and 103
Claims 25-26 and 28-31
Applicant argues “None of the cited references, alone or in combination, discloses a system where a controller receives the claimed EEG measurement from a sensor, let alone where upon receiving the EEG measurement from the sensor, the controller induces the electrode to transmit a recruiting signal that recruits the cervical ganglion”, see pg. 14 of the response filed 5/26/206. This is not persuasive. It is noted that the 102 rejections using Slavin have been withdrawn in view of the amendments made to claim 25. Regarding Sabesan, Sabesan discloses the sensor signal including an EEG measurement that includes at least a first spectral edge frequency and/or first median frequency, see “first EEG synchronization of the seizure condition of the patient by extracting first maximum wavelet coefficients in a first plurality of epochs and a plurality of frequency bands for a plurality of EEG sensors”, para. [0006].
Applicant argues “Further, even if the cited references disclosed the EEG measurement of amended claim 25, which Applicant does not concede, the references would still fail to disclose where upon receiving the EEG measurement from the sensor, the controller induces the electrode to transmit a recruiting signal that recruits the cervical ganglion.”, see pg. 14-15 of the response filed 5/26/206. This is not persuasive. Sabesan discloses a sensor that is used to measure response data, see, “The sensors 230 may be configured to acquire response data of a patient having a seizure to facilitate monitoring a physiological response of the patient to VNS therapy during a seizure.”, para. [0068] and using the sensed information to modify stimulation which is provided within a cervical level of the nerve , see “In another embodiment, the efficacy/severity analyzer 264 may provide information to the stimulation manager 260 or the stimulation analyzer 262 in order to modify parameters of the stimulation based on the efficacy of VNS therapy in reducing seizure severity.”, para. [0076].
Claims 32-38
Applicant argues “As discussed above, neither Sabesan nor Slavin discloses a system where a controller induces an electrode to transmit a recruiting signal that recruits a cervical ganglion. Further, none of the cited references discloses where the recruiting signal that recruits the cervical ganglion has an amplitude of 10 µA to 20 mA..”, see pg. 15-16 of the response filed 5/26/206. This is not persuasive. Slavin discloses providing stimulation to a cervical region, see para. [0039], the importance of the cervical ganglion, see para. [0051],[0054]-[0055] and selecting cervical region(s) for stimulation based on the importance of the cervical ganglion, see para. [0058], therefore Slavin does disclose stimulation that is provided to recruit cervical ganglion. Further, Slavin discloses that the stimulation parameters include a frequency of 100 Hz to 100 kHz and an amplitude of 10 µA to 20 mA, see “As used herein "effective amount" is variable among subjects but generally corresponds within a rate range of approximately 2 to 1000 pulses per second, a pulse width range of approximately 10 to 500 milliseconds, an amplitude range of approximately up to 10 volts, and electrode polarity set in monopolar, bipolar, tripolar or more complex pattern.”, para. [0019].
Applicant argues “In addition, none of the cited references discloses a controller that induces the electrode to transmit a recruiting signal that recruits a cervical ganglion, where recruiting the cervical ganglion includes blocking transmission of nerve signals along the cervical ganglion.”, see pg. 16 of the response filed 5/26/206. This is not persuasive. Slavin discloses providing stimulation to a cervical region, see para. [0039], the importance of the cervical ganglion, see para. [0051],[0054]-[0055] and selecting cervical region(s) for stimulation based on the importance of the cervical ganglion, see para. [0058], therefore Slavin does disclose stimulation that is provided to recruit cervical ganglion. Slavin further discloses performing cervical sympathetic blockade, see “performed cervical sympathetic blockade to treat nine patients with clinical cerebral vasospasm confirmed by angiography. They observed improvement in cerebral perfusion in all angiograms after the blockade,”, para. [0055], [0057].
Claims 39-44
Applicant argues “None of the cited references discloses a system where a controller induces an electrode to transmit a recruiting signal that recruits a cervical ganglion, upon receipt of a blood circulation velocity measured by a sensor.”, see pg. 17 of the response filed 5/26/206. This is not persuasive. It is the combination of Slavin and Zanatta which render obvious the claimed invention. Slavin discloses providing stimulation to a cervical region, see para. [0039], the importance of the cervical ganglion, see para. [0051],[0054]-[0055] and selecting cervical region(s) for stimulation based on the importance of the cervical ganglion, see para. [0058], therefore Slavin does disclose stimulation that is provided to recruit cervical ganglion. Slavin further discloses a sensor, see “assessing whether the subject has a presence of a cerebral vasospasm or an absence of a cerebral vasospasm”, para. [0018], and using that information to deliver stimulation, see “electrical impulse generator 32 is activated to deliver the desired electrical signal to only the first group of contacts based on the presence of cerebral vasospasm and activating the electrical impulse generator 32 to deliver the electrical signal to only the second group of contacts based on the absence of cerebral vasospasm.”, para. [0039]. Zanatta discloses monitoring blood flow velocity to determine brain ischemia, see abstract, “At least one brain blood flow velocity sensor is configured to sense a brain blood flow velocity of the patient”, para. [0013]-[0014], [0021]. Utilizing the combination, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Slavin to include a sensor for measuring a blood circulation velocity and using the sensed information to determine the electrical signal that will be delivered using the electrodes.
IV. Double Patenting
As noted above, in view of the amendments made to claim 25 to include the subject matter of claim 27 the double patenting rejections made against claims 25 and 31 within the office action of 2/25/2026 have been withdrawn.
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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/JG/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796
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