DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-22 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.
Regarding claims 1, 21, and 22, the phrase "and the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "and the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Dependent claims inherit the same deficiencies.
Regarding claim 16, the newly amended limitation “said controller means is configured to electronically recognize and communicate with said emitters of electrical energy and said emitters of haptic energy” renders the claim unclear. Claim 16 depends from claim 8 which ultimately depends from claim 1, where emitters of haptic energy are alternatively recited in the claim. With respect to claim 16, it is unclear if the system positively requires both haptic emitters and electrical energy emitters. In order to further advance prosecution, Examiner is interpreting the claim to recite, “said controller means is configured to electronically recognize and communicate with said emitters of electrical energy [[and]] or said emitters of haptic energy”. Examiner suggests amending the claim as discussed above to help overcome the pending 112 rejection.
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) 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Gerig (US Publication 2006/0169222) in view of Osorio (US Patent No. 6341236) and further in view of Ritzdorf (US 2014/0366814).
Regarding claim 1, Gerig discloses an improved energy neurostimulation system for stimulating at least one cranial nerve in the neck of a mammal includes an energy-generation package, energy stimulation means, controller means for controlling said energy stimulation means, and a neck worn coupling means for coupling at least one energy emitter circuit to at least one anatomical landmark corresponding with said at least one cranial nerve target (Figure 1: collar system 10), wherein:
said energy-generation package includes a power source, recharging electronics ([0018] a battery charger 22 that is intermittently connected to battery 24 in order to charge battery 24, which is schematically indicated by the dashed line of FIG. 2), and
electronic controller for controlling and conditioning electrical energy ([0018] microprocessor 30);
said energy stimulation means includes a stimulator producing stimulation energy, stimulation control and conditioning electronics, having at least one channel of stimulation energy output ([0017] electrical circuit assembly 16, which is electrically connected to electrode probes 20 for the delivery of a stimulus to the neck of the animal that is in contact with electrode probes 20);
said controller means communicates electronically with said energy-generation package and said energy stimulation means ([0017] electrical circuit assembly 16, which is electrically connected to electrode probes 20) and includes at least one controller algorithm ([0019] algorithm used by microprocessor 30 and/or circuitry);
said neck worn coupling means is configured for coupling a said at least one energy emitter circuit to the neck of a said mammal ([0019] uncoupling or coupling of the buckle of collar 12; Examiner notes the buckling of the collar would necessarily fasten the electrode probes 20 to the neck of the animal);
said at least one energy emitter circuit communicates electronically with said energy stimulator means and said controlling means ([0017] electrical circuit assembly 16 (which contains microprocessor 30), is electrically connected to electrode probes 20);
said at least one energy emitter circuit comprises at least one member selected from a group consisting of emitters of electrical energy and emitters of haptic energy ([0017] electrode probes 20 for the delivery of a stimulus to the neck of the animal that is in contact with electrode probes 20)
said neck worn coupling means includes position stabilization means to retain the position of said at least one energy emitter circuit relative to the position of a said at least one cranial nerve target ([0017] Housing 14 has an LED 18, which can be in the form of an indicator 18, attached to a portion of housing 14. Indicator 18 may be an audio and/or visual indicator).
Gerig fails to disclose said at least one algorithm included in said controller means is configured to control at least one energy stimulation parameter selected from a group that includes power amplitude, fluence, waveforms, pulse widths, phase characteristics, stimulation frequencies, stimulation session periods, stimulation duty cycle, periodicity of stimulation, total energy delivered and the like; said neck worn coupling means includes position stabilization means to retain the position of said at least one energy emitter circuit relative to the position of a said at least one cranial nerve target.
Osorio discloses a controller means including at least one controller algorithm (Col 9, lines 9-11: The following control algorithm, with reference to FIG. 6, may be utilized to minimize the effect of vagus nerve stimulation on the heart);
said at least one algorithm included in said controller means is configured to control at least one energy stimulation parameter selected from a group that includes power amplitude, fluence, waveforms, pulse widths, phase characteristics, stimulation frequencies, stimulation session periods, stimulation duty cycle, periodicity of stimulation, total energy delivered and the like (Col. 9, lines 9-11: The following control algorithm, with reference to FIG. 6, may be utilized to minimize the effect of vagus nerve stimulation on the heart; Col. 10, lines 18-20: A third option is to adjust the stimulation by adjusting the pulse frequency, amplitude, and/or width).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gerig with said at least one algorithm included in said controller means is configured to control at least one energy stimulation parameter selected from a group that includes power amplitude, fluence, waveforms, pulse widths, phase characteristics, stimulation frequencies, stimulation session periods, stimulation duty cycle, periodicity of stimulation, total energy delivered and the like as taught by Osorio since such a modification would provide the predictable results of minimizing the effect of vagal stimulation on the heart (Col. 9, lines 9-11).
Ritzdorf discloses a neck worn coupling means including anti-rotation elastomeric bristles to retain the position of said at least one energy emitter circuit relative to the position of a said at least one cranial nerve target ([0018] pinch points are soft rubber-like material rather than pointed metal prongs). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gerig with a neck worn coupling means including anti-rotation elastomeric bristles to retain the position of said at least one energy emitter circuit relative to the position of a said at least one cranial nerve target as taught by Ritzdorf. Such a modification would provide the predictable results of providing a training cue when tightening the collar without pinching the animal (Ritzdorf, Abstract).
Moreover, Examiner notes that the emitters of haptic energy have not been positively recited. As recited in claim 1, the limitation of “said at least one energy emitter circuit is selected from a group that includes emitters of electrical energy and emitters of haptic energy” claims emitters of haptic energy in the alternative. Therefore, the prior art discussed above satisfies the current claim language of claim 1.
Regarding claim 2, Gerig discloses wherein: said neck worn coupling means includes a flexible, elongated, collar apparatus configured to be worn by a said mammal ([0017] Collar 12 is connected to housing 14 and is adjustable to fit the animal's neck; Figure 1 shows collar 12 being a flexible elongated structure that is buckled together);
said at least one energy emitter circuit is attached, in part or in whole, to said flexible, elongated, collar apparatus ([0017] Housing 14 contains electrical circuit assembly 16, which is electrically connected to electrode probes 20 for the delivery of a stimulus to the neck of the animal that is in contact with electrode probes 20).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gerig (US Publication 2006/0169222) in view of Osorio (US Patent No. 6341236) and Ritzdorf (US 2014/0366814) and further in view of Anderson et al (US 4941313) hereinafter Anderson.
Regarding claim 3, Gerig discloses said at least one energy emitter circuit is installed, in part or in whole, on at least one positionally adjustable car assembly attached to said flexible, elongated, collar apparatus ([0017] Collar 12 is connected to housing 14 and is adjustable to fit the animal's neck);
said at least one adjustable car assembly includes position-locking means to secure its position on said flexible, elongated, collar apparatus (Examiner notes there would necessarily have to be a position locking means to secure position of housing 14 to collar 12 since they are connected to each other [0017]);
said flexible, elongated, collar apparatus includes said at least one position verification means configured as at least one visually observable marker ([0017] Housing 14 has an LED 18, which can be in the form of an indicator 18, attached to a portion of housing 14. Indicator 18 may be an audio and/or visual indicator).
Gerig fails to disclose wherein the car assembly is slidable along the flexible, elongated, collar apparatus while the flexible, elongated, collar apparatus does not rotate around said mammal’s neck. However, Anderson discloses a car assembly (Col. 3, line 65: outer tubular housing 41) that is slidable along a flexible, elongated, collar apparatus while the flexible, elongated, collar apparatus does not rotate around said mammal’s neck (Col. 3, lines 40-43: the muzzle loop has a slide locking adjustment device shown generally at 40 mounted thereon; Fig. 1); and
said at least one adjustable car assembly includes position-locking means to secure its position on said flexible, elongated, collar apparatus (Col. 4, lines 13-15: a friction lock for the slide-locking device).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gerig with a car assembly that is slidable along a flexible, elongated, collar apparatus while the flexible, elongated, collar apparatus does not rotate around said mammal’s neck; and said at least one adjustable car assembly includes position-locking means to secure its position on said flexible, elongated, collar apparatus as taught by Anderson. Such a modification would provide the predictable results of easily positioning the housing on the animal’s neck without the need for snaps, buckles, or other fasteners that might be released by a dog pawing.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gerig (US Publication 2006/0169222) in view of Osorio (US Patent No. 6341236) and Ritzdorf (US 2014/0366814) and Anderson (US 4941313) and Ecker (US Publication 2016/0242387) and further in view of Hardi (US Publication 2011/0061605).
Regarding claim 4, Gerig discloses said controller means includes energy monitoring means configured to monitor the connection between said at least one energy emitter means and said mammal's skin for at least one factor belonging to a group that includes electrical conductivity or electrical resistance ([0018] Microprocessor 30 is additionally connected to signal detection circuitry 36); said energy monitoring means are configured for monitoring energy emitted by said energy emitter means ([0021] During the generation of this high voltage output pulse, microprocessor 30 monitors the output of containment signal detection circuits 36 for the presence of a signal pulse).
Gerig fails to disclose at least one electronic controller device selected from a group consisting of a conventional desktop computer, a portable notebook-type computer, a smartphone, a tablet, a dedicated electronic fob, and a wearable electronic control device; said at least one electronic controller device includes hardware and software configured for wireless electronic communication with said controller means and said energy stimulation means; said controller means is configured to detect moisture proximal to electrical stimulation contacts on said mammal's body; said controller means is configured to disable energy stimulation upon the detection of said moisture.
Ecker discloses at least one electronic controller device selected from a group that includes a conventional desktop computer, a portable notebook-type computer, a smartphone, a tablet, a dedicated electronic fob, and a wearable electronic control device, and the like ([0058] the delivery unit 11 can further be configured to be in communication with a remote computing device 26; the remote computing device 26 may comprise a laptop, a tablet PC, or a smartphone);
said at least one electronic controller device includes hardware and software configured for wireless electronic communication with said controller means and said energy stimulation means ([0058] The communication between the remote computing device 26 and the system 10 can be facilitated by a suitable wireless communications network 28).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Grieg with at least one electronic controller device selected from a group that includes a conventional desktop computer, a portable notebook-type computer, a smartphone, a tablet, a dedicated electronic fob, and a wearable electronic control device, and the like; said at least one electronic controller device includes hardware and software configured for wireless electronic communication with said controller means and said energy stimulation means as taught by Ecker since such a modification would provide the predictable results of allowing remote monitoring and control of the delivered stimulation.
Hardi discloses said controller means is configured to detect moisture proximal to electrical stimulation contacts on said mammal's body ([0074] the sensors 65A, 65B may be arranged to sense moisture);
said controller means is configured to disable energy stimulation upon the detection of said moisture ([0074] Signals from the sensors 65A, 65B may be used to trigger alarms and/or implement other actions; Figure 7 shows sensors 65A-B being coupled to the micro-processor which is coupled to the shock element 68).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with said controller means is configured to detect moisture proximal to electrical stimulation contacts on said mammal's body; and said controller means is configured to disable energy stimulation upon the detection of said moisture as taught by Hardi since such a modification would provide the predictable results of reducing the risk of burns on the neck of the animal.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gerig (US Publication 2006/0169222) in view of Osorio (US Patent No. 6341236) and Ritzdorf (US 2014/0366814) and Anderson (US 4941313) and Ecker (US Publication 2016/0242387) and Hardi (US Publication 2011/0061605) and further in view of Simon et al (US Publication 2013/0245486) hereinafter Simon.
Regarding claim 5, the modified Gerig discloses the system of claim 4 as discussed above, but fails to disclose wherein: said at least one cranial nerve target is the cervical branch of the vagus nerve. However Simon discloses wherein: said at least one cranial nerve target is the cervical branch of the vagus nerve ([0066] FIG. 7 illustrates the approximate position of the housing of the stimulator in a neck collar according one embodiment of the present invention, when used to stimulate the right vagus nerve in the neck of a child; [0122] FIG. 7 shows the stimulator 30 applied to the neck of a child, which is partially immobilized with a foam cervical collar 78). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with said at least one cranial nerve target is the cervical branch of the vagus nerve as taught by Simon since such a modification would provide the predictable results of treating a medical condition, such as migraine headache, by electrically stimulating a nerve noninvasively, which may be a vagus nerve situated within a patient's neck (Simon, Abstract).
Claim(s) 6-7 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Gerig (US Publication 2006/0169222) in view of Osorio (US Patent No. 6341236) and Ritzdorf (US 2014/0366814) and Anderson (US 4941313) and Ecker (US Publication 2016/0242387) and Hardi (US Publication 2011/0061605) and Simon (US Publication 2013/0245486) and further in view of Hollis (US Patent No. 6263836).
Regarding claim 6, the modified Gerig discloses the system of claim 5 as discussed above, but fails to disclose a graphical user interface configured to provide selective control of at least two stimulation parameters belonging to a group that includes power amplitude, fluence, waveforms, wavelengths, pulse widths, phase characteristics, stimulation channels, stimulation frequencies, stimulation session periods, signal duty cycle, and time intervals of stimulation delivery, stimulation periodicity, total energy delivered, and the like.
Hollis discloses a graphical user interface configured to provide selective control of at least two stimulation parameters belonging to a group that includes power amplitude, fluence, waveforms, wavelengths, pulse widths, phase characteristics, stimulation channels, stimulation frequencies, stimulation session periods, signal duty cycle, and time intervals of stimulation delivery, stimulation periodicity, total energy delivered, and the like (Figure 1: host unit 17; Col. 3, lines 16-23: Another object of the present invention is to provide a host unit with a microprocessor allowing inputting monitoring and training instructions into a remote unit having a microprocessor, adjusting operating parameters in the remote unit microprocessor, and navigating through a decision process to select active functions, voice messages, sound levels, electric stimulation voltage level, and electric stimulation duration).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with a graphical user interface configured to provide selective control of at least two stimulation parameters belonging to a group that includes power amplitude, fluence, waveforms, wavelengths, pulse widths, phase characteristics, stimulation channels, stimulation frequencies, stimulation session periods, signal duty cycle, and time intervals of stimulation delivery, stimulation periodicity, total energy delivered, and the like as taught by Hollis since such a modification would provide the predictable results of allowing remote monitoring and control of the delivered stimulation.
Regarding claim 7, the modified Gerig discloses the system of claim 6 as discussed above, but fails to disclose said at least one electronic controller device includes hardware configured to enable internet connectivity and the communicative exchange of data with at least one remote server; said at least one electronic controller includes software configured for remote control of said energy stimulation by a remote operator via said internet connectivity.
Ecker discloses said at least one electronic controller device includes hardware configured to enable internet connectivity and the communicative exchange of data with at least one remote server ([0058] The communication between the remote computing device 26 and the system 10 can be facilitated by a suitable wireless communications network 28 such as, the Internet (WiFi));
said at least one electronic includes software configured for remote control of said energy stimulation by a remote operator via said internet connectivity ([0058] the delivery unit 11 can further be configured to be in communication with a remote computing device 26 via a dedicated software program (i.e., a computer application) for the remote operation thereof).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with said at least one electronic controller device includes hardware configured to enable internet connectivity and the communicative exchange of data with at least one remote server; said at least one electronic controller includes software configured for remote control of said energy stimulation by a remote operator via said internet connectivity as taught by Ecker since such a modification would provide the predictable results of allowing remote monitoring and control of the delivered stimulation.
Regarding claims 9-12, Examiner notes that these claims positively recite “emitters of haptic energy” which depend on the alternative limitation of “said at least one energy emitter circuit is selected from a group that includes emitters of electrical energy and emitters of haptic energy” recited in claim 1. As discussed above, “emitters of haptic energy” was not positively recited in claim 1 and not required to satisfy the current claim language. Therefore, the prior art discussed above with respect to the rejection of claim 1 satisfies the claim language as currently written. Claims 9-12 are rejected by virtue of dependency. The limitations of claims 9-12 directed to details of the emitters of haptic energy merely further define optional elements and do not make the optional elements of the preceding claims required.
Claim(s) 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Gerig (US Publication 2006/0169222) in view of Osorio (US Patent No. 6341236) and Ritzdorf (US 2014/0366814) and Anderson (US 4941313) and Ecker (US Publication 2016/0242387) and Hardi (US Publication 2011/0061605) and Simon (US Publication 2013/0245486) and Hollis (US Patent No. 6263836) and further in view of Pardo et al (US Publication 2006/0259077) hereinafter Pardo.
Regarding claim 8, Gerig discloses said at least one energy emitter circuit includes electrodes configured to emit electrical energy ([0017] and electrode probes 20), but fails to disclose said electrodes emit electrical stimulation current having at least one frequency selected from a range of electrical frequencies between 0.5 hertz to 20,000 hertz; said electrodes emit electrical stimulation in pulses having a pulse width between 100 and 1000 milliseconds; said electrodes emit electrical stimulation in duty cycles having a stimulation-on periodicity between 10 seconds and 5 minutes; said electrodes emit electrical stimulation in duty cycles having a stimulation-off periodicity between 10 seconds and 5 minutes.
Pardo discloses said electrodes emit electrical stimulation current having at least one frequency selected from a range of electrical frequencies between 0.5 hertz to 20,000 hertz ([0007] pulse repetition frequency at about 20-30 Hz);
said electrodes emit electrical stimulation in pulses having a pulse width between 100 and 1000 milliseconds ([0007] a pulse width of 500 milliseconds (ms));
said electrodes emit electrical stimulation in duty cycles having a stimulation-on periodicity between 10 seconds and 5 minutes ([0007] on/off cycle of one minute on and 1.8 minutes off);
said electrodes emit electrical stimulation in duty cycles having a stimulation-off periodicity between 10 seconds and 5 minutes ([0007] on/off cycle of one minute on and 1.8 minutes off).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with said electrodes emit electrical stimulation current having at least one frequency selected from a range of electrical frequencies between 0.5 hertz to 20,000 hertz; said electrodes emit electrical stimulation in pulses having a pulse width between 100 and 1000 milliseconds; said electrodes emit electrical stimulation in duty cycles having a stimulation-on periodicity between 10 seconds and 5 minutes; said electrodes emit electrical stimulation in duty cycles having a stimulation-off periodicity between 10 seconds and 5 minutes as taught by Pardo since such a modification would provide the predictable results of treating obesity using chronic cervical vagal nerve stimulation (Pardo, Abstract).
Regarding claim 16, the modified Gerig discloses the system of claim 8 as discussed above, but fails to disclose said neck worn coupling means and controller means are configured for modular interchangeability of said emitters of electrical energy and said emitters of haptic energy; said controller means is configured to electronically recognize and communicate with said emitters of electrical energy and said emitters of haptic energy; said controller is configured to control selected said energy emitter circuit according to established parameters associated with the said energy emitter circuit module selected for use.
However, Hardi discloses said neck worn coupling means and controller means are configured for modular interchangeability of said emitters of electrical energy and said emitters of haptic energy ([0053] at least one operating mode includes administration of a warning signal (e.g., vibration, audible signal, and/or electric shock of low intensity);
said controller means is configured to electronically recognize and communicate with said emitters of electrical energy and said emitters of haptic energy; said controller is configured to control selected said energy emitter circuit according to established parameters associated with the said energy emitter circuit module selected for use ([0053] administer a correction/discipline signal (e.g., high amplitude vibration and/or electric shock of higher intensity) if the pet wearing the pet tag or collar does not cease an offending behavior; Examiner notes the controller would have to recognize and communicate with the modular emitter in order to deliver a shock or vibration).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with said neck worn coupling means and controller means are configured for modular interchangeability of said emitters of electrical energy and said emitters of haptic energy; said controller means is configured to electronically recognize and communicate with said emitters of electrical energy and said emitters of haptic energy; said controller is configured to control selected said energy emitter circuit according to established parameters associated with the said energy emitter circuit module selected for use as taught by Hardi. Such a modification would provide the predictable results of administering a warning signal and a correction/discipline signal (Hardi, [0053]).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Gerig (US Publication 2006/0169222) in view of Osorio (US Patent No. 6341236) and Ritzdorf (US 2014/0366814) and Anderson (US 4941313) and Ecker (US Publication 2016/0242387) and Hardi (US Publication 2011/0061605) and Simon (US Publication 2013/0245486) and Hollis (US Patent No. 6263836) and Pardo (US Publication 2006/0259077) and further in view of Yaron (US Publication 2004/0049121).
Regarding claim 13, Gerig discloses at least one electrical output inductive transducer-transmitter, at least one receiver-emitter means, and a neck worn coupling means for coupling said at least one electrical output inductive transducer-transmitter to at least one anatomical landmark corresponding with said at least one cranial nerve target ([0018] antenna & RF receiver 40 and Antenna coils & amplifiers 42; [0019] uncoupling or coupling of the buckle of collar 12);
said at least one electrical output inductive transducer-transmitter is installed on said adjustable car removably attached to said neck worn coupling means ([0017] Collar 12 is connected to housing 14 and is adjustable to fit the animal's neck; Housing 14 contains transducer; Housing 14 contains electrical circuit assembly 16), but fails to disclose said at least one electrical output inductive transducer-transmitter is in electronic communication with said energy-generation package; said at least one electrical output inductive transducer-transmitter is configured to convert electricity into an electromagnetic field; said at least one receiver-emitter means is comprised to receive electromagnetic energy generated by said at least one electrical output inductive transducer-transmitter; said at least one receiver-emitter means includes an electromagnetic induction receiver to convert electromagnetic energy into electric current for electrical stimulation of said at least one cranial nerve target.
Yaron discloses at least one electrical output inductive transducer-transmitter ([0066] electromagnetic fields generated by transducers such as electromagnetic field generators 26);
said at least one electrical output inductive transducer-transmitter is in electronic communication with said energy-generation package ([0070] element 24 comprises a stimulator; Figure 1 shows transducers 26 being coupled to the control unit 90 and stimulator 24);
said at least one electrical output inductive transducer-transmitter is configured to convert electricity into an electromagnetic field ([0066] electromagnetic fields generated by transducers such as electromagnetic field generators 26);
said at least one receiver-emitter means is comprised to receive electromagnetic energy generated by said at least one electrical output inductive transducer-transmitter ([0066] the term "transducers 26" means either electromagnetic field generators and/or electromagnetic field receivers);
said at least one receiver-emitter means includes an electromagnetic induction receiver to convert electromagnetic energy into electric current for electrical stimulation of said at least one cranial nerve target ([0066] the term "transducers 26" means either electromagnetic field generators and/or electromagnetic field receivers).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with at least one electrical output inductive transducer-transmitter; said at least electrical output inductive transducer-transmitter is in electronic communication with said energy-generation package; said at least one electrical output inductive transducer-transmitter is configured to convert electricity into an electromagnetic field; said at least one receiver-emitter means is comprised to receive electromagnetic energy generated by said at least one electrical output inductive transducer-transmitter; said at least one receiver-emitter means includes an electromagnetic induction receiver to convert electromagnetic energy into electric current for electrical stimulation of said at least one cranial nerve target as taught by Yaron since such a modification would provide the predictable results of sensing an electrical activity and transmitting an electrical activity signal responsive thereto (Yaron, Abstract).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Gerig (US Publication 2006/0169222) in view of Osorio (US Patent No. 6341236) and Ritzdorf (US 2014/0366814) and Anderson (US 4941313) and Ecker (US Publication 2016/0242387) and Hardi (US Publication 2011/0061605) and Simon (US Publication 2013/0245486) and Hollis (US Patent No. 6263836) and Pardo (US Publication 2006/0259077) and Yaron (US Publication 2004/0049121) and Baumann et al (US Publication 2002/0138115) hereinafter Baumann and further in view of Govari et al (US Publication 2005/0027192) hereinafter Govari.
Regarding claim 14, Gerig discloses signaling means to provide installation guidance and positioning monitoring to facilitate positioning and alignment of said at least one electromagnetic transducer proximal to said at least one receiver-emitter means ([0017] Housing 14 has an LED 18, which can be in the form of an indicator 18, attached to a portion of housing 14. Indicator 18 may be an audio and/or visual indicator), but fails to disclose said at least one receiver-emitter means includes at least one elongated magnetic component having a north pole and a south pole; said at least one receiver-emitter means is comprised within a biocompatible package configured for percutaneous implantation subcutaneously under the skin of said mammal; said at least one position verification means includes a Hall sensor configured to detect and monitor the proximity and position of a said at least one elongated magnetic composition included in said at least one receiver-emitter means; said at least one elongated magnetic component has a north pole and a south pole.
Baumann discloses said at least one receiver-emitter means includes at least one magnetic component having a north pole and a south pole ([0068] permanent magnet cooperates with an electromagnetic coil in the manner of an electromagnetic transducer; Examiner notes that all magnets have a north and south pole);
said at least one receiver-emitter means is comprised within a biocompatible package configured for percutaneous implantation subcutaneously under the skin of said mammal (Figure 5 shows transducer 60 being implanted).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with at least one receiver-emitter means includes at least one magnetic component having a north pole and a south pole; said at least one receiver-emitter means is comprised within a biocompatible package configured for percutaneous implantation subcutaneously under the skin of said mammal as taught by Baumann. Such a modification would provide the predictable results of providing a permanent magnet which cooperates with an electromagnetic coil to deliver stimulation.
The modified Gerig discloses the claimed invention but does not disclose expressly the elongated magnetic component. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by the modified Gerig with the elongated magnetic component, because the only difference between the prior art disclosed above and the claimed elongated magnetic component is a recitation of relative dimensions (degree of elongation) and the claimed elongated magnetic component would not perform differently than the magnetic component taught by Baumann (MPEP 2144.04 (IV)(A)). One of ordinary skill in the art, furthermore, would have expected Applicant' s invention to perform equally well with the magnetic component as taught by Baumann, because it provides cooperation with an electromagnetic coil and since it appears to be an arbitrary design consideration which fails to patentably distinguish over the modified Gerig. Therefore, it would have been an obvious matter of design choice to further modify Gerig to obtain the invention as specified in the claim(s).
Govari discloses said at least one position verification means includes a Hall sensor configured to detect and monitor the proximity and position of a said at least one elongated magnetic composition included in said at least one receiver-emitter means ([0004] Field sensors, such as Hall effect devices, coils or antennae, have been included in medical devices to allow for noninvasive monitoring of the position of the devices). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with said at least one position verification means includes a Hall sensor configured to detect and monitor the proximity and position of a said at least one elongated magnetic composition included in said at least one receiver-emitter means as taught by Govari since such a modification would provide the predictable results of noninvasive monitoring of the position of a device (Govari, [0004]).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gerig (US Publication 2006/0169222) in view of Osorio (US Patent No. 6341236) and Ritzdorf (US 2014/0366814) and Anderson (US 4941313) and Ecker (US Publication 2016/0242387) and Hardi (US Publication 2011/0061605) and Simon (US Publication 2013/0245486) and Hollis (US Patent No. 6263836) and Pardo (US Publication 2006/0259077) and Yaron (US Publication 2004/0049121) and Baumann (US Publication 2002/0138115) and Govari (US Publication 2005/0027192) and further in view of Yakovlev et al (US Publication 2016/0331956) hereinafter Yakovlev.
Regarding claim 15, Gerig discloses a signaling means selected from a group that includes a light source and a sound generator, each producing stimulus easily detectable by ordinary human sensory faculties ([0017] Housing 14 has an LED 18, which can be in the form of an indicator 18, attached to a portion of housing 14. Indicator 18 may be an audio and/or visual indicator), but fails to disclose said biocompatible package containing said at least one receiver-emitter means is composed of glass, plastic or a combination thereof; said biocompatible package containing said at least one receiver-emitter means additionally includes a radio frequency identification (RFID) circuit.
Yakovlev discloses said biocompatible package containing said at least one receiver-emitter means is composed of glass, plastic or a combination thereof ([0111] When implanted in the body, these mechanisms can be packaged with epoxies or plastics that encapsulate it for bio-compatibility). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with said biocompatible package containing said at least one receiver-emitter means is composed of glass, plastic or a combination thereof as taught by Yakovlev since such a modification would provide the predictable results of ensuring the device is safe for implantation.
Govari discloses said biocompatible package containing said at least one receiver-emitter means additionally includes a radio frequency identification (RFID) circuit ([0034] a wireless medical device, which is adapted to be inserted into a body of a subject, the device including a power circuit, which is adapted to be driven inductively by a radio-frequency (RF) electromagnetic field so as to provide operating energy to the device). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with biocompatible package containing said at least one receiver-emitter means additionally includes a radio frequency identification (RFID) circuit as taught by Govari since such a modification would provide the predictable results of providing external communication to allow for remote control and monitoring.
Claim(s) 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gerig (US Publication 2006/0169222) in view of Osorio (US Patent No. 6341236) and Ritzdorf (US 2014/0366814) and Anderson (US 4941313) and Ecker (US Publication 2016/0242387) and Hardi (US Publication 2011/0061605) and Simon (US Publication 2013/0245486) and Hollis (US Patent No. 6263836) and Pardo (US Publication 2006/0259077) and further in view of La Rovere et al (US Publication 2020/0345970) hereinafter La Rovere.
Regarding claim 17, the modified Gerig discloses the system of claim 8 as discussed above, but fails to disclose at least one photoplethysmography sensor configured for monitoring the cardiopulmonary activity of a said mammal; said at least one photoplethysmography sensor is configured to monitor at least one cardio- respiratory parameter selected from a group consisting of heart rate, respiratory rate, heart rate variability, arrhythmia, normal sinus rhythm, oxygen saturation and blood pressure; said at least one controller algorithm is configured to control the delivery of energy stimulation in accordance with algorithm determinants and data obtained from said photoplethysmography sensor.
However, La Rovere discloses at least one photoplethysmography sensor configured for monitoring the cardiopulmonary activity of a said mammal (Claim 8: said at least one biofeedback sensor means selected from a group that includes sensors configured for photoplethysmography);
said at least one photoplethysmography sensor is configured to monitor at least one cardio- respiratory parameter selected from a group consisting of heart rate, respiratory rate, heart rate variability, arrhythmia, normal sinus rhythm, oxygen saturation and blood pressure (Claim 8: said photoplethysmography configured to monitor at least one cardio-respiratory parameter belonging to a group that includes heart rate, respiratory rate, heart rate variability, arrhythmia, normal sinus rhythm, oxygen saturation and blood pressure);
said at least one controller algorithm is configured to control the delivery of energy stimulation in accordance with algorithm determinants and data obtained from said photoplethysmography sensor (Claim 8: algorithmic control means configured for controlling the delivery of energy stimulation in accordance with algorithm determinants and data obtained from said biofeedback sensor means).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with at least one photoplethysmography sensor configured for monitoring the cardiopulmonary activity of a said mammal; said at least one photoplethysmography sensor is configured to monitor at least one cardio- respiratory parameter selected from a group consisting of heart rate, respiratory rate, heart rate variability, arrhythmia, normal sinus rhythm, oxygen saturation and blood pressure; said at least one controller algorithm is configured to control the delivery of energy stimulation in accordance with algorithm determinants and data obtained from said photoplethysmography sensor as taught by La Rovere. Such a modification would provide the predictable results of increased efficacy of the system by modulating the stimulation based on sensed data in order to avoid delivering unnecessary stimulation to the patient.
Regarding claim 18, the modified Gerig discloses the system of claim 17 as discussed above, but fails to disclose said at least one photoplethysmography sensor configured to detect and monitor cardiologic activity of said mammal, particularly respiratory sinus arrhythmia, normal sinus rhythm and pathological heart rhythms also known as arrhythmias; said detection of said respiratory sinus arrhythmia (RSA) is accomplished by monitoring to detect the periods of heart rate acceleration and deceleration associated with periods of said respiratory sinus arrhythmia (RSA); said energy stimulation is gated according to said at least one algorithm configured to commence or end periods of energy stimulation in relation to the detection of said respiratory sinus arrhythmia; said energy stimulation is gated according to said at least one control algorithm configured to commence or end periods of energy stimulation in relation to the detection of said normal sinus rhythm; said monitoring of said cardiologic activity of said mammal may be used to adjust said at least one stimulation parameter selected from a group consisting of stimulation frequency, waveform, pulse rate, pulse width, stimulation amplitude, stimulation duration, stimulation periodicity, and the like; said monitoring of said cardiologic activity of a said mammal may be used to commence, delay or terminate stimulation according to detected pathological heart rhythms known as arrhythmias.
However, La Rovere discloses said at least one photoplethysmography sensor configured to detect and monitor cardiologic activity of said mammal, particularly respiratory sinus arrhythmia, normal sinus rhythm and pathological heart rhythms also known as arrhythmias (Claim 9: sensors means that includes said photoplethysmography sensor means; said photoplethysmograph monitoring is configured to detect cardiologic activity of a user, particularly normal sinus rhythm, pathological arrhythmias, and respiratory sinus arrhythmia also known as RSA);
said detection of said respiratory sinus arrhythmia (RSA) is accomplished by monitoring to detect the periods of heart rate acceleration and deceleration associated with periods of said respiratory sinus arrhythmia (RSA)(Claim 9: said detection of said respiratory sinus arrhythmia is accomplished by monitoring to detect the start and end of periods of said respiratory sinus arrhythmia);
said energy stimulation is gated according to said at least one algorithm configured to commence or end periods of energy stimulation in relation to the detection of said respiratory sinus arrhythmia (Claim 9: said photoplethysmographic monitoring of said respiratory sinus arrhythmia is used to gate stimulation according to detected said respiratory sinus arrhythmia);
said energy stimulation is gated according to said at least one control algorithm configured to commence or end periods of energy stimulation in relation to the detection of said normal sinus rhythm (Claim 9: aid photoplethysmographic monitoring of said normal sinus rhythm is used to gate stimulation according to detected said normal sinus rhythm);
said monitoring of said cardiologic activity of said mammal may be used to adjust said at least one stimulation parameter selected from a group consisting of stimulation frequency, waveform, pulse rate, pulse width, stimulation amplitude, stimulation duration, stimulation periodicity, and the like (Claim 9: at least one algorithm is composed for selectively controlling stimulation parameters according to algorithm determinants and monitored bodily-generated, sensor-received data selected from a group of sensors means that includes said photoplethysmography sensor means; Claim 1: said controller means is configured to control energy stimulation parameters selected from a group that includes stimulation frequency, waveform, pulse rate, pulse width, amplitude, stimulation duration, stimulation periodicity, and the like);
said monitoring of said cardiologic activity of said mammal may be used to commence, delay or terminate stimulation according to detected pathological heart rhythms known as arrhythmias (Claim 9: said cardiologic activity of a user is used to gate stimulation according to detected pathological heart rhythms known as arrhythmias).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with said at least one photoplethysmography sensor configured to detect and monitor cardiologic activity of said mammal, particularly respiratory sinus arrhythmia, normal sinus rhythm and pathological heart rhythms also known as arrhythmias; said detection of said respiratory sinus arrhythmia (RSA) is accomplished by monitoring to detect the periods of heart rate acceleration and deceleration associated with periods of said respiratory sinus arrhythmia (RSA); said energy stimulation is gated according to said at least one algorithm configured to commence or end periods of energy stimulation in relation to the detection of said respiratory sinus arrhythmia; said energy stimulation is gated according to said at least one control algorithm configured to commence or end periods of energy stimulation in relation to the detection of said normal sinus rhythm; said monitoring of said cardiologic activity of a said mammal may be used to adjust said at least one stimulation parameter selected from a group consisting of stimulation frequency, waveform, pulse rate, pulse width, stimulation amplitude, stimulation duration, stimulation periodicity, and the like; said monitoring of said cardiologic activity of a said mammal may be used to commence, delay or terminate stimulation according to detected pathological heart rhythms known as arrhythmias as taught by La Rovere. Such a modification would provide the predictable results of increased efficacy of the system by modulating the stimulation based on sensed data in order to avoid delivering unnecessary stimulation to the patient.
Regarding claim 19, the modified Gerig discloses the system of claim 18 as discussed above, but fails to disclose at least one bodily activity sensor means is an actimetry sensor configured for sensing and monitoring the bodily movement of said mammal; said at least one controller algorithm is configured to control the delivery of energy stimulation in accordance with algorithm determinants and data obtained from said bodily activity sensing means. However, La Rovere discloses at least one bodily activity sensor means is an actimetry sensor configured for sensing and monitoring the bodily movement of said mammal (Claim 8: at least one bodily activity sensor means configured for sensing the movement and bodily position of a said human being);
said at least one controller algorithm is configured to control the delivery of energy stimulation in accordance with algorithm determinants and data obtained from said bodily activity sensing means (Claim 8: algorithmic control means configured for controlling the delivery of energy stimulation in accordance with algorithm determinants and data obtained from said biofeedback sensor means and said bodily activity sensing means).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with at least one bodily activity sensor means is an actimetry sensor configured for sensing and monitoring the bodily movement of said mammal; said at least one controller algorithm is configured to control the delivery of energy stimulation in accordance with algorithm determinants and data obtained from said bodily activity sensing means as taught by La Rovere. Such a modification would provide the predictable results of increased efficacy of the system by modulating the stimulation based on sensed data in order to avoid delivering unnecessary stimulation to the patient.
Regarding claim 20, the modified Gerig discloses the system of claim 19 as discussed above, but fails to disclose an algorithm-operated and algorithm-controlled closed-loop system, wherein: said photoplethysmography is further configured to continuously monitor at least one index of autonomic nervous system activity; said at least one index of photoplethysmographically monitored autonomic nervous system activity includes one or more frequency domains of Heart Rate Variability selected from a group consisting of high frequency, low frequency, very low frequency and ratios thereof, and the like; said bodily activity sensors further comprise sensors configured for monitoring the acceleration, motion, and position of the body in whole or in part; said at least one algorithm is composed for selectively controlling one or more stimulation parameters according to algorithm determinants and said at least one index of photoplethysmographically monitored autonomic nervous system activity, and data from said biofeedback sensors and bodily movement sensors; said closed loop system may be comprised as a self-contained wearable system having a power source, and energy conditioning control electronics; said one or more stimulation parameters controlled by said algorithm are selected from a group that includes energy frequency, energy intensity, stimulation time duration, energy pulse width, energy waveform, stimulation duty cycle, power amplitude, fluence, waveforms, wavelengths, pulse widths, phase characteristics, stimulation channels, stimulation session periods, signal duty cycle, periodicity of stimulation, total energy delivered and the like.
However, La Rovere discloses an algorithm-operated and algorithm-controlled closed-loop system (Claim 10: an algorithm-operated and algorithm-controlled closed-loop system),
wherein: said photoplethysmography is further configured to continuously monitor at least one index of autonomic nervous system activity (Claim 10: said photoplethysmography sensor means is further configured to monitor at least one index of autonomic nervous system activity);
said at least one index of photoplethysmographically monitored autonomic nervous system activity includes one or more frequency domains of Heart Rate Variability selected from a group consisting of high frequency, low frequency, very low frequency and ratios thereof, and the like (Claim 10: said photoplethysmographically monitored at least one index of autonomic nervous system activity includes one or more heart rate variability (HRV) frequency domains selected from a group that includes high frequency, low frequency, very low frequency and ratios thereof, and the like);
said bodily activity sensors further comprise sensors configured for monitoring the acceleration, motion, and position of the body in whole or in part (Claim 10: said movement and bodily position sensors are configured for monitoring the acceleration, motion, and position of the body in whole or in part);
said at least one algorithm is composed for selectively controlling one or more stimulation parameters according to algorithm determinants and said at least one index of photoplethysmographically monitored autonomic nervous system activity, and data from said biofeedback sensors and bodily movement sensors (Claim 10: said at least one algorithm is composed for selectively controlling one or more stimulation parameters according to algorithm determinants and said at least one monitored index of autonomic nervous system activity, and data from said biofeedback sensor means and movement and bodily position sensors);
said closed loop system may be comprised as a self-contained wearable system having a power source, and energy conditioning control electronics (Claim 10: said closed loop system is further comprised as a self-contained wearable system having a power source and control electronics);
said one or more stimulation parameters controlled by said algorithm are selected from a group that includes energy frequency, energy intensity, stimulation time duration, energy pulse width, energy waveform, stimulation duty cycle, power amplitude, fluence, waveforms, wavelengths, pulse widths, phase characteristics, stimulation channels, stimulation session periods, signal duty cycle, periodicity of stimulation, total energy delivered and the like (Claim 10: said one or more stimulation parameters controlled by said at least one algorithm are selected from a group that includes energy frequency, energy intensity, stimulation time duration, energy pulse width, energy waveform, stimulation duty cycle, power amplitude, fluence, waveforms, wavelengths, pulse widths, phase characteristics, stimulation channels, stimulation session periods, signal duty cycle, periodicity of stimulation, total energy delivered and the like).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Gerig with an algorithm-operated and algorithm-controlled closed-loop system, wherein: said photoplethysmography is further configured to continuously monitor at least one index of autonomic nervous system activity; said at least one index of photoplethysmographically monitored autonomic nervous system activity includes one or more frequency domains of Heart Rate Variability selected from a group consisting of high frequency, low frequency, very low frequency and ratios thereof, and the like; said bodily activity sensors further comprise sensors configured for monitoring the acceleration, motion, and position of the body in whole or in part; said at least one algorithm is composed for selectively controlling one or more stimulation parameters according to algorithm determinants and said at least one index of photoplethysmographically monitored autonomic nervous system activity, and data from said biofeedback sensors and bodily movement sensors; said closed loop system may be comprised as a self-contained wearable system having a power source, and energy conditioning control electronics; said one or more stimulation parameters controlled by said algorithm are selected from a group that includes energy frequency, energy intensity, stimulation time duration, energy pulse width, energy waveform, stimulation duty cycle, power amplitude, fluence, waveforms, wavelengths, pulse widths, phase characteristics, stimulation channels, stimulation session periods, signal duty cycle, periodicity of stimulation, total energy delivered and the like as taught by La Rovere. Such a modification would provide the predictable results of increased efficacy of the system by modulating the stimulation based on sensed data in order to avoid delivering unnecessary stimulation to the patient.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Gerig (US Publication 2006/0169222) in view of Osorio (US Patent No. 6341236) and further in view of Anderson et al (US 4941313) hereinafter Anderson.
Regarding claim 21, Gerig discloses an improved energy neurostimulation system for stimulating at least one cranial nerve in the neck of a mammal includes an energy-generation package ([0017] housing 14), energy stimulation means ([0018] high voltage circuit 34), controller means for controlling said energy stimulation means ([0018] microprocessor 30), and a neck worn coupling means ([0019] buckle of collar 12) for coupling at least one energy emitter circuit to at least one anatomical landmark corresponding with said at least one cranial nerve target, wherein:
said neck worn coupling means ([0019] buckle of collar 12) includes a flexible, elongated, collar apparatus configured to be worn by said mammal ([0017] Collar 12 is connected to housing 14 and is adjustable to fit the animal's neck);
said energy-generation package ([0017] housing 14) includes a power source ([0018] Battery 24), recharging electronics ([0018] battery charger 22), and an electronic controller for controlling and conditioning electrical energy ([0018] Microprocessor 30);
said energy stimulation means includes a stimulator producing stimulation energy ([0018] high voltage (HV) circuit 34), stimulation control and conditioning electronics ([0018] Microprocessor 30 and demodulator 38), having at least one channel of stimulation energy output ([0017] electrical circuit assembly 16, which is electrically connected to electrode probes 20);
said controller means communicates electronically with said energy-generation package and said energy stimulation means (Fig. 2) and includes at least one controller algorithm ([0019] Method 100 is carried out by an algorithm used by microprocessor 30);
said at least one energy emitter circuit installed, in part or in whole, on at least one positionally adjustable car assembly attached to said flexible, elongated, collar apparatus ([0017] Housing 14 contains electrical circuit assembly 16 and is connected to collar 12);
said at least one energy emitter circuit communicates electronically with said energy stimulator means and said controlling means ([0017] electrical circuit assembly 16, which is electrically connected to electrode probes 20 for the delivery of a stimulus);
said at least one energy emitter circuit comprises at least one member selected from a group consisting of emitters of electrical energy and emitters of haptic energy ([0018] high voltage circuit 34);
said neck worn coupling means includes at least one position verification means (LED) for verifying the alignment of said at least one energy emitter circuit with a said at least one cranial nerve target ([0017] Housing 14 has an LED 18, which can be in the form of an indicator 18, attached to a portion of housing 14. Indicator 18 may be an audio and/or visual indicator);
said neck worn coupling means includes position stabilization means to retain the position of said at least one energy emitter circuit relative to the position of a said at least one cranial nerve target ([0017] Collar is adjustable; Fig. 1 shows holes on collar 12 and a buckle where the collar can be tightened to stabilize the housing against the animal’s neck).
Gerig fails to disclose wherein the car assembly is slidable along the flexible, elongated, collar apparatus while the flexible, elongated, collar apparatus does not rotate around said mammal’s neck; and said at least one algorithm included in said controller means is configured to control at least one energy stimulation parameter selected from a group that includes power amplitude, fluence, waveforms, pulse widths, phase characteristics, stimulation frequencies, stimulation session periods, stimulation duty cycle, periodicity of stimulation, total energy delivered and the like.
However, Anderson discloses a car assembly (Col. 3, line 65: outer tubular housing 41) that is slidable along a flexible, elongated, collar apparatus while the flexible, elongated, collar apparatus does not rotate around said mammal’s neck (Col. 3, lines 40-43: the muzzle loop has a slide locking adjustment device shown generally at 40 mounted thereon; Fig. 1). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gerig with a car assembly that is slidable along a flexible, elongated, collar apparatus while the flexible, elongated, collar apparatus does not rotate around said mammal’s neck as taught by Anderson. Such a modification would provide the predictable results of easily positioning the housing on the animal’s neck without the need for snaps, buckles, or other fasteners that might be released by a dog pawing.
Osorio discloses a controller means including at least one controller algorithm (Col 9, lines 9-11: The following control algorithm, with reference to FIG. 6, may be utilized to minimize the effect of vagus nerve stimulation on the heart); said at least one algorithm included in said controller means is configured to control at least one energy stimulation parameter selected from a group that includes power amplitude, fluence, waveforms, pulse widths, phase characteristics, stimulation frequencies, stimulation session periods, stimulation duty cycle, periodicity of stimulation, total energy delivered and the like (Col. 9, lines 9-11: The following control algorithm, with reference to FIG. 6, may be utilized to minimize the effect of vagus nerve stimulation on the heart; Col. 10, lines 18-20: A third option is to adjust the stimulation by adjusting the pulse frequency, amplitude, and/or width). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gerig with said controller means includes at least one controller algorithm; said at least one algorithm included in said controller means is configured to control at least one energy stimulation parameter selected from a group that includes power amplitude, fluence, waveforms, pulse widths, phase characteristics, stimulation frequencies, stimulation session periods, stimulation duty cycle, periodicity of stimulation, total energy delivered and the like as taught by Osorio since such a modification would provide the predictable results of minimizing the effect of vagal stimulation on the heart (Osorio, Col. 9, lines 9-11).
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Gerig (US Publication 2006/0169222) in view of Osorio (US Patent No. 6341236) and further in view of Faltys et al (US 2011/0190849) hereinafter Faltys.
Regarding claim 22, Gerig discloses an improved energy neurostimulation system for stimulating at least one cranial nerve in the neck of a mammal includes an energy-generation package ([0017] housing 14), energy stimulation means ([0018] high voltage circuit 34), controller means for controlling said energy stimulation means ([0018] microprocessor 30), and a neck worn coupling means ([0019] buckle of collar 12) for coupling at least one energy emitter circuit ([0017] electrical circuit assembly 16) to at least one anatomical landmark corresponding with said at least one cranial nerve target, wherein:
said energy-generation package includes a power source ([0018] battery 24), recharging electronics ([0018] battery charger 22), and an electronic controller for controlling and conditioning electrical energy ([0018] microprocessor 30);
said energy stimulation means includes a stimulator producing stimulation energy ([0034] high voltage circuit 34), stimulation control and conditioning electronics ([0018] microprocessor 30), having at least one channel of stimulation energy output ([0017] electrical circuit assembly 16, which is electrically connected to electrode probes 20);
said controller means communicates electronically with said energy-generation package and said energy stimulation means ([0018] Microprocessor 30 is additionally connected a monitoring circuits 32, high voltage circuit 34, signal detection circuitry 36, demodulator 38, receiver 40 and antenna coils & amplifiers 42; Fig. 2) and includes at least one controller algorithm ([0019] Method 100 is carried out by an algorithm used by microprocessor 30);
said neck worn coupling means is configured for coupling a said at least one energy emitter circuit to the neck of a said mammal ([0017] Collar 12 is connected to housing 14 and is adjustable to fit the animal's neck; [0019] buckle of collar 12);
said at least one energy emitter circuit communicates electronically with said energy stimulator means and said controlling means ([0018] Microprocessor 30 is additionally connected a monitoring circuits 32, high voltage circuit 34, signal detection circuitry 36, demodulator 38, receiver 40 and antenna coils & amplifiers 42; Fig. 2);
said at least one energy emitter circuit comprises at least one member selected from a group consisting of emitters of electrical energy and emitters of haptic energy ([0018] high voltage circuit 34);
said neck worn coupling means includes at least one position verification means for verifying the alignment of said at least one energy emitter circuit with a said at least one cranial nerve target ([0017] Housing 14 has an LED 18, which can be in the form of an indicator 18, attached to a portion of housing 14. Indicator 18 may be an audio and/or visual indicator);
said neck worn coupling means includes position stabilization means to retain the position of said at least one energy emitter circuit relative to the position of a said at least one cranial nerve target ([0017] Collar is adjustable; Fig. 1 shows holes on collar 12 and a buckle where the collar can be tightened to stabilize the housing against the animal’s neck).
Gerig fails to disclose wherein said energy stimulation means comprises a subcutaneous energy receiver-emitter configured for percutaneous implantation subcutaneously under the skin of said mammal proximate to the at least one cranial nerve, and wherein the subcutaneous energy receiver-emitter emits the stimulation energy, wherein the stimulation energy comprises haptic energy, electric energy, or a combination thereof; said at least one algorithm included in said controller means is configured to control at least one energy stimulation parameter selected from a group that includes power amplitude, fluence, waveforms, pulse widths, phase characteristics, stimulation frequencies, stimulation session periods, stimulation duty cycle, periodicity of stimulation, total energy delivered and the like.
However, Faltys discloses a subcutaneous energy receiver-emitter configured for percutaneous implantation subcutaneously under the skin of said mammal proximate to the at least one cranial nerve ([0065] implanted microstimulator), and
wherein the subcutaneous energy receiver-emitter emits the stimulation energy ([0065] stimulating the subject's vagus nerve),
wherein the stimulation energy comprises haptic energy, electric energy, or a combination thereof ([0065] implanting a microstimulator in the patient's neck in electrical communication with a cervical region of the subject's vagus nerve).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gerig with a subcutaneous energy receiver-emitter configured for percutaneous implantation subcutaneously under the skin of said mammal proximate to the at least one cranial nerve, and wherein the subcutaneous energy receiver-emitter emits the stimulation energy, wherein the stimulation energy comprises haptic energy, electric energy, or a combination thereof as taught by Faltys. Such a modification would provide the predictable results of modulating inflammation (Faltys, [0065]).
Osorio discloses a controller means including at least one controller algorithm (Col 9, lines 9-11: The following control algorithm, with reference to FIG. 6, may be utilized to minimize the effect of vagus nerve stimulation on the heart); said at least one algorithm included in said controller means is configured to control at least one energy stimulation parameter selected from a group that includes power amplitude, fluence, waveforms, pulse widths, phase characteristics, stimulation frequencies, stimulation session periods, stimulation duty cycle, periodicity of stimulation, total energy delivered and the like (Col. 9, lines 9-11: The following control algorithm, with reference to FIG. 6, may be utilized to minimize the effect of vagus nerve stimulation on the heart; Col. 10, lines 18-20: A third option is to adjust the stimulation by adjusting the pulse frequency, amplitude, and/or width). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gerig with said controller means includes at least one controller algorithm; said at least one algorithm included in said controller means is configured to control at least one energy stimulation parameter selected from a group that includes power amplitude, fluence, waveforms, pulse widths, phase characteristics, stimulation frequencies, stimulation session periods, stimulation duty cycle, periodicity of stimulation, total energy delivered and the like as taught by Osorio since such a modification would provide the predictable results of minimizing the effect of vagal stimulation on the heart (Osorio, Col. 9, lines 9-11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792