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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS, see IDS filed 3/14/2024, have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper filed of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this Office Action.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] recites related application 17/165231 which has now matured into a patent, the paragraph should be updated to include the issued patent number.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2010/0042193 to Slavin (Slavin) (cited by applicant).
In reference to at least claim 25
Slavin discloses a system comprising: an esophageal catheter including at least one 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 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]).
In reference to at least claim 31
Slavin discloses 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]).
Claim(s) 25-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0310070 to Sabesan (Sabesan).
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]).
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 27
Sabesan discloses 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 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) (cited by applicant).
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 fore 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 2010/0042193 to Slavin (Slavin) in view of US 2010/0240971 to Zanatta (Zanatta ).
In reference to at least claim 30
Slavin teaches a system according to claim 25 and further discloses a system 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 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 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]).
Claim(s) 32-36 and 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).
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]).
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 38
Slavin discloses positioning the catheter such that the electrode is within an oroesophageal cavity (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) 37 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) (cited by applicant).
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).
Claim(s) 39, 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 2006/0111754 to Rezai et al. (Rezai).
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 does not explicitly teach the sensor measuring a pupil diameter, a blood circulation velocity in a blood vessel in a brain, a skin temperature, a perspiration rate, or a perspiration density.
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]).
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 skin temperature, a perspiration rate, or a perspiration density, 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 41
Slavin modified by Rezai renders obvious a system according to claim 39. 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 pupilary response, see rejection of claim 39 above), 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]).
In reference to at least claim 43
Slavin modified by Rezai renders obvious a system according to claim 39. 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, see rejection of claim 39 above); 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, see rejection of claim 39 above); 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, see rejection of claim 39 above); 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]).
In reference to at least claim 44
Slavin modified by Rezai renders obvious a system according to claim 39. 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, see rejection of claim 39 above), 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]).
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 2006/0111754 to Rezai et al. (Rezai) as applied to claim 39 further in view of US 2011/0172500 to Van Dooren et al. (Van).
In reference to at least claim 40
Slavin modified by Rezai renders obvious a system according to claim 39. Rezai further discloses the sensor data including 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]).
However, Slavin modified by Rezai does not disclose the sensor including an infrared monitoring device. It was well known in the art to use a non-contact infrared sensing thermometer for measuring skin temperature as evidence by Van (e.g. para. [0034]). 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 a skin temperature as such technique was well known in the art and would have provided the predictable result of providing a non-contact method of sensing skin temperature (‘500, para. [0034]).
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0042193 to Slavin (Slavin) in view of US 2006/0111754 to Rezai et al. (Rezai) as applied to claim 39 further in view of US 2010/0240971 to Zanatta (Zanatta).
In reference to at least claim 42
Slavin modified by Rezai renders obvious a system according to claim 39. Rezai further discloses comparing sensor data (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 based on the comparison adjusting 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]).
Slavin modified by Rezai does not explicitly teach the sensor measuring being configured to measure a blood circulation velocity in a blood vessel in a brain including a first and second blood circulation velocity.
Zanatta, in the same field of brain monitoring, 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 further modify the system of Slavin modified by Rezai 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]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 25 and 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 and 10-11 of U.S. Patent No.11,944,810. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims in the instant application and U.S. Patent No.11,944,810 recite a system that includes an esophageal catheter including at least one electrode, a sensor and a controller in communication with the electrode and sensor and upon receiving a first signal from the sensor, the controller induces the at least one electrode to transmit a recruiting signal that recruits a cervical ganglion which includes the stellate ganglion, see claim chart below. The claims in the instant application recite a cervical ganglion instead of stellate ganglion, however stellate ganglion is part of the cervical ganglion. Claims 25 and 31 in the instant application are more generic than the claims within U.S. Patent No.11,944,810 since claims 25 and 31 within the instant application do not recite measuring a peripheral blood flow, i.e. the claims within the instant application are generic to the claims recited within U.S. Patent No.11,944,810. The entire scope of claims 25 and 31 in the instant application fall within the scope of claims 4 and 10-11 of U.S. Patent No.11,944,810, therefore the claims within U.S. Patent No.11,944,810 fully anticipate the claimed genus in the instant application, therefore a patent to the genus would improperly extend the right to exclude granted to the species or sub-genus claimed within U.S. Patent No.11,944,810, see MPEP 804.
Instant Application
U.S. Patent No.11,944,810
Claim 25: (New) A system comprising: an esophageal catheter including at least one electrode; a sensor; and a controller in communication with the at least one electrode and the sensor; wherein, upon receiving a signal from the sensor, the controller induces the electrode to transmit a recruiting signal that recruits a cervical ganglion.
Claim 4: A system comprising: an esophageal catheter including at least one electrode; one or more sensors for measuring a peripheral blood flow; and a controller in communication with the at least one electrode and the one or more sensors; wherein, upon receiving a first signal from the one or more sensors based on the peripheral blood flow, the controller induces the at least one electrode to transmit a recruiting signal that recruits the sympathetic ganglion, wherein the at least one electrode is at least one first electrode, the sympathetic ganglion is a left stellate ganglion, the recruiting signal is a first recruiting signal, and upon receiving the first signal from the one or more sensors, the controller also induces at least one second electrode to transmit a second recruiting signal that recruits a right stellate ganglion.
Claim 25 (New) A system comprising: an esophageal catheter including at least one electrode; a sensor; and a controller in communication with the at least one electrode and the sensor; wherein, upon receiving a signal from the sensor, the controller induces the electrode to transmit a recruiting signal that recruits a cervical ganglion.
Claim 10: A system comprising: an esophageal catheter including a plurality of electrodes, where a first electrode of the plurality of electrodes is positioned on a surface of the catheter and opposite a second electrode of the plurality of electrodes, where the first electrode and second electrode are positioned at a same axial level; a first sensor for measuring a left pupil diameter; a second sensor for measuring a right pupil diameter; and a controller in communication with the at least one electrode and the first and second sensors; wherein, upon receiving a first signal from the first sensor based on the left pupil diameter, the controller induces the first electrode to transmit a first recruiting signal that recruits a left stellate ganglion; and upon receiving a second signal from the second sensor based on the right pupil diameter, the controller induces the second electrode to transmit a second recruiting signal that recruits a right stellate ganglion.
Claim 31 (New) A system comprising: an esophageal catheter including at least one electrode; a sensor; and a controller in communication with the at least one electrode and the sensor; wherein, upon receiving a signal from the sensor, the controller induces the electrode to transmit a recruiting signal that recruits a cervical ganglion, wherein recruiting the cervical ganglion includes blocking transmission of nerve signals along the cervical ganglion.
Claim 11: A system comprising: an esophageal catheter including a plurality of electrodes, where a first electrode of the plurality of electrodes is positioned on a surface of the catheter and opposite a second electrode of the plurality of electrodes, where the first electrode and second electrode are positioned at a same axial level; a first sensor for measuring a left pupil diameter; a second sensor for measuring a right pupil diameter; and a controller in communication with the at least one electrode and the first and second sensors; wherein, upon receiving a first signal from the first sensor based on the left pupil diameter, the controller induces the first electrode to transmit a first recruiting signal that recruits a left stellate ganglion; and upon receiving a second signal from the second sensor based on the right pupil diameter, the controller induces the second electrode to transmit a second recruiting signal that recruits a right stellate ganglion, wherein recruiting the left stellate ganglion includes blocking transmission of nerve signals along the left stellate ganglion, and/or recruiting the right stellate ganglion includes blocking transmission of nerve signals along the right stellate ganglion.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Patent No. 7,340,298 to Barbut discloses enhancement of cerebral blood flow by electrical nerve stimulation.
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/JENNIFER L GHAND/Examiner, Art Unit 3796