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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/23/2026 has been entered.
Amendment
This action is in response to the Amendment filed on 1/23/2026.
Claims 1, 5, 7, 22, 25, 48, 54, 71, 74, 77, 96, 100,114,118,149, 185 and 188 are pending.
Applicant elected Species B (Administering epidural stimulation) in the response to the Restriction requirement (Please see response filed on 7/19/2023) and therefore the examiner agrees that claims 22, 25, 74 and 77 are withdrawn pursuant to that election of species.
Claims 1, 5, 7, 48, 54, 71, 96, 100, 114, 118,149, 185 and 188 are examined as discussed below.
Response to Arguments
Applicant's arguments filed 1/23/2026 have been fully considered but they are not persuasive.
Claim Rejections - 35 U.S.C. § 112
In view of the amendments, the rejections under 35 U.S.C. 112 provided in the office action mailed on 2/3/2025 have been withdrawn. However, in view of the amendments, new rejections under 35 U.S.C. 112 have been provided as discussed below in the current office action.
Claim Rejections - 35 U.S.C. §§ 102 and 103
Independent Claim 1
As amended, claim 1 recites:
A method of restoring respiration, said method comprising:
administering a stimulation pattern comprising a frequency of up to 200 Hz and an intensity by neuromodulating the thoracic spinal cord, and/or the lumbar spinal cord, of said subject by administering epidural stimulation to the thoracic spinal cord or a region thereof, and/or the lumbar spinal cord or a region thereof at the frequency and the intensity to induce coordinated respiration, wherein the frequency and the intensity are sufficient to restore respiration;
and
removing the stimulation pattern, wherein coordinated respiration persists after removal,
where said neuromodulating is applied based on the pattern, wherein the frequency and the intensity activates a respiratory drive that provides coordinated activation and release of diaphragm, laryngeal, hypoglossal, and intercostal muscles to provide inspiratory and expiratory flow, and wherein the stimulation pattern is responsive to afferent sensory feedback.
Applicant argues that the cited art fails to teach or suggest administrating a stimulation at a frequency and intensity sufficient to restore respiration and removing the stimulation, wherein coordinated respiration persists after removal. they state that paragraph [0468] of the present application describes the impacts of "stimulation on respiratory frequency that persists after removal of the stimulation," such as "a sustained increase in respiratory frequency." Applicant respectfully asserts that DiMarco in view of Pitts fails to disclose such coordinated respiration after removal of stimulation.
They argue that DiMarco does not teach or suggest the removal of the stimulation pattern, wherein coordination respiration persists after removal. In fact, DiMarco makes no mention of achieving coordination respiration after removal of a stimulation. Rather, DiMarco is directed only to the production of a cough. DiMarco fails to acknowledge any such coordinated respiration that persists after removal of the described stimulation. That is, DiMarco only describes the production of a cough during the application of the stimulation. See, e.g., DiMarco, par. [0013], [0020], [0024], [0048], and [0072]. DiMarco is silent to any affects the stimulation has on the coordination of respiration once the stimulation is removed.
The examiner respectfully disagrees with applicant’s arguments for the following reasons. DiMarco teaches that in spinal cord injury (SCI) patients, development of respiratory complications is directly related to their inability to cough and clear secretions (e.g. [0004]). They also teach providing stimulation intermittently (for 30 minutes) and that cough is often used repetitively over short time periods to expel secretions. Spinal cord stimulation (SCS) was performed at home by either the subjects themselves or caregivers 2-3 times/day on a chronic basis, and also as needed for secretion management (e.g. [0101]). They further teach that the degree of difficulty in removing secretions improved markedly and the need for alternative methods of secretion removal were virtually eliminated. Subject life quality related to respiratory care also improved with subjects reporting greater control of their breathing problems (e.g. [0102]) and therefore they teach stimulation reduced the need for alternative methods of secretion removal thus clearing the airways and restoring coordinated respiration after removing the stimulation.
Therefore the rejections are maintained.
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 48, 54 and 71 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.
Claim 48 as recited depends on claim 18 which has been cancelled. Therefore the dependency of claim 48 is unclear. Claims 54 and 71 which depend on claim 48 inherit the deficiency. For the purpose of examination, claim 48 is considered as being dependent on claim 1.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 5, 7, 18, 48, 54, 100 and 118 and are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DiMarco (U.S. Patent Application Publication Number: US 2014/0058490 A1, hereinafter “DiMarco”- PREVIOUSLY CITED) or, in the alternative, under 35 U.S.C. 103 as obvious over DiMarco (U.S. Patent Application Publication Number: US 2014/0058490 A1, hereinafter “DiMarco”- PREVIOUSLY CITED) in view of Pitts et al (U.S. Patent Application Publication Number: US 2015/0209583 A1, hereinafter “Pitts”- PREVIOUSLY CITED).
Regarding claims 1, 48, and 118, Di Marco teaches a method and a stimulator to induce epidural electrical stimulation to perform the method of restoring respiration said method comprising:
administering a stimulation pattern comprising a frequency of up to 200 Hz and an intensity by neuromodulating the thoracic spinal cord, and/or the lumbar spinal cord (( Di Marco teaches a frequency of 10 Hz to 1000Hz (e.g. [0017], [0023],[0025]) and therefore they teach said epidural stimulation at a frequency that overlaps upto 200 Hz) and Di Marco further teaches that the stimulation voltage is 10V to 50V and the pulse amplitude is 1mA to 40mA and the pulse width of 10 microseconds to 10 second OR 200 sec to 400 sec (e.g. [0017],[0023],[0025], Note: these are the ranges as claimed in claim 48) of said subject by administering epidural stimulation to the thoracic spinal cord or a region thereof (i.e. electrodes are positional on the dorsal epidural surface of the spinal cord at the thoracic and lumber level e.g. Abstract, [0018]-[0020], Fig. 7), and/or the lumbar spinal cord or a region thereof at the frequency and the intensity (e.g. [0017]-[0020],[0023]-[0025]), and
removing the stimulation pattern, wherein coordinated respiration persists after removal (e.g. [0101], [0102]: the degree of difficulty in removing secretions improved markedly and the need for alternative methods of secretion removal were virtually eliminated. Subject life quality related to respiratory care also improved with subjects reporting greater control of their breathing problems)
where said neuromodulating is applied based on the pattern, wherein the frequency and the intensity activates a respiratory drive that provides coordinated activation and release of diaphragm, laryngeal, hypoglossal, and intercostal muscles to provide inspiratory and expiratory flow, and wherein the stimulation pattern is responsive to afferent sensory feedback.
(As discussed in the previous office action, DiMarco teaches epidural stimulation parameters as claimed in claim 48. Since Di Marco teaches dorsal epidural stimulation of the spinal cord at the claimed stimulation parameters of frequency and intensity as claimed in the dependent claims of the current application, they teach the frequency and the intensity activates a respiratory drive that provides coordinated activation and release of diaphragm, laryngeal, hypoglossal, and intercostal muscles to provide inspiratory and expiratory flow, and wherein the stimulation pattern is responsive to afferent sensory feedback as claimed.)
In the alternative, Di Marco teaches the invention as claimed except for the step of the stimulation pattern is responsive to afferent sensory feedback.
Pitts teaches a system and method of controlling coughing and swallowing using a cough pattern generator and a swallow pattern generator (e.g. Fig. 7, [0044]) and also teaches that the patient may initiate a programmed change in the electrical stimulation (for example by pressing a button). Alternatively, EMG (electromyographic) activity is tracked by a muscle monitoring device of the disclosure, and a programmed change in the electrical stimulation is initiated independent of the patient (e.g. [0045]) to generate a stimulation pattern configured to regulate and/or to restore respiration in response to one or more sensory inputs comprising a frequency and intensity which is used to provide neuromodulation (e.g. [0047],[0048],[0057], [0058]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the system and method in teachings of DiMarco and generate a pattern of stimulation as taught by Pitts in order to provide the predictable results of a more customized or patient specific algorithm for better therapeutic outcome.
Regarding claim 5, DiMarco OR DiMarco in view of Pitts teaches the invention as claimed and Di Marco further teaches said neuromodulating comprises neuromodulating a dorsal surface of the spinal cord (e.g. [0018] Fig. 7); and/or
said neuromodulating comprises neuromodulating a ventral surface of the spinal cord.
Regarding claim 7, DiMarco OR DiMarco in view of Pitts teaches the invention as claimed and Di Marco further teaches that the leads are positioned over the dorsal epidural surface of the spinal cord at the T9 to L1 level (e.g. [0018]-[0019], [0023]-[0025]) and therefore they teach said method comprises administering epidural stimulation to: a region selected from the group consisting of T1-T1, T1-T2, T1-T3, T1-T4, T1- TS, T1-T6, T1-T7, T1-T8, T1-T9, T1-T10, T1-T11, T1-T12, T2-T2, T2-T3, T2-T4, T2-T5, T2-T6, T2- T7, T2-T8, T2-T9, T2-T10, T2-T11, T2-T12, T3-T3, T3-T4, T3-T5, T3-T6, T3-T7, T3-T8, T3-T9, T3- T10, T3-T11, T3-T12, T4-T4, T4-T5, T4-T6, T4-T7, T4-T8, T4-T9, T4-T10, T4-T11, T4-T12, T5-T5, T5S-T6, T5-T7, T5-T8, T5-T9, T5-T10, T5-T11, T5-T12, T6-T6, T6-T7, T6-T8, T6-T9, T6-T10, To- T11, T6-T12, T7-T7, T7-T8, T7-T9, T7-T10, T7-T11, T7-T12, T8-T8, T8-T9, T8-T10, T8-T11, T8- T12, T9-T9, T9-T10, T9-T11, T9-T12, T10-T10, T10-T11, T10-T12, T11-T11, T11-T12, and T12- T12; and/or
a region selected from the group consisting of L1-L1, L1-L2 , L1-L3, L1-L4, LI-L5, L1-S1, L1-S2, L1-S3, L1-S4, L1-S5, L2-L2 , L2-L3, L2-L4, L2-L5, L2-S1, L2-S2, L2-S3, L2- S4, L2-S5, L3-L3, L3-L4, L3-L5, L3-S1, L3-S2, L3-S3, L3-S4, L3-S5, L4-L4, L4-L5, L4-S1, L4-S2, L4-S3, L4-S4, L4-S5, L5-L5 , L5-S1, L5-S2, L5-S3, L5-S4, L5-S5, S1-S1, S1-S2, S1-S3, S1-S4, S1- 85, S2-S2, S2-S3, S2-S4, S2-S5, S3-S3, S3-S4, S3-S5, S4-S4, S4-S5, and S5-S6.
Regarding claim 48, DiMarco OR DiMarco in view of Pitts teaches the invention as claimed and Di Marco further teaches that the stimulation voltage is 10V to 50V and the pulse amplitude is 1mA to 40mA and the pulse width of 10 microseconds to 10 second OR 200 sec to 400 sec (e.g. [0017],[0023],[0025]) and therefore they teach said epidural stimulation is at an amplitude ranging from 0.5 mA, or from 1 mA, or from 2 mA, or from 3 mA, or from 4 mA, or from 5 mA up to 50 mA, or up to 30 mA, or up to 20 mA, or up to 15 mA, or from 5 mA to 20 mA, or from 5 mA up to 15 mA;
and/or said stimulation comprises pulsing having a pulse width that ranges from 100 s up to about 1 s or up to 800 s, or up to 600 s, or up to 500 s, or up to 400 s, or up to 300 s, or up to 200 s, or up to 100 s, or from 150 s up to 600 s, or from 200 s up to 500 s, or from 200 s up to 400 s;
and/or said epidermal stimulation is at a frequency, pulse width, and amplitude sufficient to restore a resting respiration rate and at least 60%, or at least 70%, or at least 80%, or at least 90% of the subject’s normal tidal volume.
Regarding claim 54, DiMarco OR DiMarco in view of Pitts teaches the invention as claimed and Di Marco further teaches that the electrodes are placed on a dorsal epidural surface of the spinal cord (e.g. [0015]-[0020], Fig. 7) and stimulation is applied and therefore they teach said epidural stimulation is applied to the dorsal (posterior) column; and/or said epidural stimulation is applied to the lateral portion of said dorsal (posterior) column; and/or said epidural stimulation is applied to a dorsal root; and/or said epidural stimulation is applied to a ventral (anterior) column; and/or said epidural stimulation is applied to a lateral portion of a ventral column; and/or said epidural stimulation is applied to a ventral root.
Regarding claim 100, DiMarco OR DiMarco in view of Pitts teaches the invention as claimed and Di Marco further teaches that said subject has a respiratory deficiency and wherein said respiratory deficiency is due to a spinal cord injury (e.g. Abstract, [0001]); or said respiratory deficiency is due to an ischemic brain injury; or said respiratory deficiency is due to a neurodegenerative disorder; or said respiratory deficiency is due to sudden infant death syndrome (SIDS); or said subject is in intensive care unit patient with decreased respiratory drive; or said respiratory deficiency is acute respiratory distress syndrome (ARDS), or acute respiratory failure; or said respiratory deficiency is due to alcohol intoxication and/or a drug overdose.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over DiMarco (U.S. Patent Application Publication Number: US 2014/0058490 A1, hereinafter “DiMarco”- PREVIOUSLY CITED) OR DiMarco (U.S. Patent Application Publication Number: US 2014/0058490 A1, hereinafter “DiMarco”- PREVIOUSLY CITED) in view of Pitts et al (U.S. Patent Application Publication Number: US 2015/0209583 A1, hereinafter “Pitts”- PREVIOUSLY CITED) and further in view of Ayanoor-Vitikkate et al (U.S. Patent Application Publication Number: US 2012/0053645 A1, hereinafter “Ayanoor-Vitikkate”- PREVIOUSLY CITED).
Regarding claim 71, DiMarco OR DiMarco in view of Pitts teaches the claimed invention as discussed above, and DiMarco further teaches a wire leads with an electrode array of four electrodes (e.g. Fig. 2) but do not specifically teach using an electrode array that has a configuration that is a 32 channel dorsal respiration electrode type A; or said electrode array has a configuration that is a 48 channel dorsal respiration electrode type B; or said electrode array has a configuration that is an 8 channel ventral respiration dual electrode type C having an inferolateral exiting electrode tail.
In a similar field of endeavor, Ayanoor-Vitikkate teaches a spinal cord stimulation system and method (e.g. Abstract, [0003],[0043], Fig. 1) comprising a paddle lead with 32 or 48 or 8 channels dual electrode type electrode array (e.g. Fig. 4, [0045], [0063],[0064]). Therefore they teach an electrode array that has a configuration that is a 32 channel dorsal respiration electrode type A; or said electrode array has a configuration that is a 48 channel dorsal respiration electrode type B; or said electrode array has a configuration that is an 8 channel ventral respiration dual electrode type C having an inferolateral exiting electrode tail. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the leads in the method of DiMarco OR DiMarco in view of Pitts to include at least 32 or 48 or 8 channels dual electrode type arrays with an inferolateral exiting tail as taught by Ayanoor-Vitikkate in order to provide the predictable results of improving the stimulation by providing a more targeted stimulation along the spinal column.
Claims 96 and 149 is rejected under 35 U.S.C. 103 as being unpatentable over DiMarco (U.S. Patent Application Publication Number: US 2014/0058490 A1, hereinafter “DiMarco” - PREVIOUSLY CITED) OR DiMarco (U.S. Patent Application Publication Number: US 2014/0058490 A1, hereinafter “DiMarco”- PREVIOUSLY CITED) in view of Pitts et al (U.S. Patent Application Publication Number: US 2015/0209583 A1, hereinafter “Pitts”- PREVIOUSLY CITED) and further in view of Rezai (U.S. Patent Application Publication Number: US 2006/0111754 A1, hereinafter “Rezai” - PREVIOUSLY CITED).
Regarding claim 96, DiMarco OR DiMarco in view of Pitts teaches the claimed invention as discussed above, but does not specifically teach App. No: 16/479,201Page 9said stimulation is applied by a stimulator configured to alter a stimulation pattern in response to respiration rate and/or tidal volume; and/or said stimulation is applied by a stimulator configured to alter a stimulation pattern in response to heart rate.
In a similar field of endeavor, Rezai teaches a stimulation system and method for treating respiratory or pulmonary medical conditions by stimulating the T-1 through T-4 ganglia, cervical ganglia, and combinations thereof (e.g. Abstract, [0019]) comprising a sensor (e.g. [0007],[0045],[0047]) for sensing respiration function or oxygenation saturation or electrocardiograms and adjusting stimulation therapy based on the sensor signal (e.g. Claim 13). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the method of DiMarco OR DiMarco in view of Pitts to alter a stimulation pattern in response to respiration rate sensed by a sensor and/or said stimulation is applied by a stimulator configured to alter a stimulation pattern in response to heart rate sensed by a sensors as taught by Rezai in order to provide the predictable results of improving the outcome of the therapy by providing a more targeted and optimized therapy based on patient response.
Regarding claim 149, DiMarco OR DiMarco in view of Pitts teaches a system (e.g. Abstract) comprising:
a stimulator configured to induce epidural and/or transcutaneous electrical stimulation and/or magnetic stimulation according to claim 1 (i.e. bipolar electrical stimulation, is then applied to activate the expiratory muscles and produce cough, electrodes are positional on the dorsal epidural surface of the spinal cord at the thoracic and lumber level e.g. Abstract, [0018],[0019], Fig. 7).
DiMarco OR DiMarco in view of Pitts does not specifically teach one or more sensors selected from the group consisting of a sensor that detects chest wall movement and/or expansion, a sensor that detects blood 02 saturation, and a sensor that determines end tidal CO2; where the output of said sensor is coupled to said stimulator and said stimulator adjust the stimulation pattern in response to the sensor output to provide a desired tidal volume and/or 02 saturation and/or end tidal CO2.
In a similar field of endeavor, Rezai teaches a stimulation system and method for treating respiratory or pulmonary medical conditions by stimulating the T-1 through T-4 ganglia and combinations thereof (e.g. Abstract, [0019]) comprising a sensor (e.g. [0007],[0045],[0047]) for sensing respiration function or oxygenation saturation or electrocardiograms and adjusting stimulation therapy based on the sensor signal (e.g. Claim 13). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the method of DiMarco OR DiMarco in view of Pitts to alter a stimulation pattern in response to respiration rate sensed by a sensor and/or said stimulation is applied by a stimulator configured to alter a stimulation pattern in response to heart rate sensed by a sensors as taught by Rezai in order to provide the predictable results of improving the outcome of the therapy by providing a more targeted and optimized therapy based on patient response.
Claim 114 is rejected under 35 U.S.C. 103 as being unpatentable over DiMarco (U.S. Patent Application Publication Number: US 2014/0058490 A1, hereinafter “DiMarco”- PREVIOUSLY CITED) OR DiMarco (U.S. Patent Application Publication Number: US 2014/0058490 A1, hereinafter “DiMarco”- PREVIOUSLY CITED) in view of Pitts et al (U.S. Patent Application Publication Number: US 2015/0209583 A1, hereinafter “Pitts”- PREVIOUSLY CITED) and further in view of Lu et al (International Publication Number: WO 2015/048563 A1, hereinafter “Lu”- PREVIOUSLY CITED).
Regarding claim 114, DiMarco OR DiMarco in view of Pitts teaches the claimed invention as discussed above but none of the references teach administering at least one monoaminergic agonist to said subject.
In a similar field of endeavor, Lu teaches an epidural spinal cord stimulation method and system (e.g. [0005] Fig. 1) providing stimulation at the cervical spinal level and also proving a monoaminergic agonist in conjunction with the stimulation (e.g. [0009], [0114]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the method of DiMarco OR DiMarco in view of Pitts and administer at least one monoaminergic agonist to said subject in order to provide the predictable results of improving the outcome of the therapy by modulating the excitability of the spinal neuromotor networks.
Claim 185 is rejected under 35 U.S.C. 103 as being unpatentable over DiMarco (U.S. Patent Application Publication Number: US 2014/0058490 A1, hereinafter “DiMarco”- PREVIOUSLY CITED) OR DiMarco (U.S. Patent Application Publication Number: US 2014/0058490 A1, hereinafter “DiMarco”- PREVIOUSLY CITED) in view of Pitts et al (U.S. Patent Application Publication Number: US 2015/0209583 A1, hereinafter “Pitts”- PREVIOUSLY CITED) and further in view of Francois et al (U.S. Patent Application Publication Number: US 2014/0142652 A1, hereinafter “Francois”- PREVIOUSLY CITED) OR Ignagni et al (U.S. Patent Number: US 7840270 B2, hereinafter “Ignagni”- PREVIOUSLY CITED).
Regarding claim 185, DiMarco OR DiMarco in view of Pitts teaches a method of claim 1 as discussed above, but do not specifically teach that the method is performed while said subject is removed from the respirator (ventilator) and/or after said subject is removed from said respirator.
Francois teaches a system for providing stimulation (e.g. Fig.3) to help the subject in re-learning effective breathing while on a ventilator (e.g. [0114]). Ignani is another teaching that discloses that it is beneficial to provide electrical stimulation while the patient is breathing using a mechanical ventilator to help wean the patient off the mechanical ventilator (e.g. Col. 7 lines 523). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the method of DiMarco OR DiMarco in view of Pitts while the patient is on a ventilator or in the process of being weaned of the ventilator as taught by Francois OR Ignagni in order to provide the predictable results of improving the quality of life of the patient and reducing costs.
Claim 188 is rejected under 35 U.S.C. 103 as being unpatentable over DiMarco (U.S. Patent Application Publication Number: US 2014/0058490 A1, hereinafter “DiMarco”- PREVIOUSLY CITED) in view of Pitts et al (U.S. Patent Application Publication Number: US 2015/0209583 A1, hereinafter “Pitts”- PREVIOUSLY CITED).
Regarding claim 188, DiMarco OR DiMarco in view of Pitts teaches the claim invention as discussed in the method of claim 1 above, but does not specifically teach receiving a command from voice and/or an application on a computer, a smartphone, or a tablet to provide user control over one or more parameters from the group consisting of stimulation frequency, stimulation amplitude, stimulation pulse width, carrier frequency, and amplitude; and wherein neuromodulation is performed based on the command.
Pitts further teaches receiving (i.e. an audio information e.g. [0005], [0006], [0045]: the patient can indicate to the system that a swallow and or cough is expected, Such indication may take place in the form of a switch setting on the system, a gesture carried out upon the system, or by the individual, or a spoken command understood by the system) command from voice and/or an application on a computer to provide user control over one or more parameters from the group consisting of stimulation frequency, stimulation amplitude, stimulation pulse width, carrier frequency, and amplitude and wherein stimulation is performed based on the command. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the system and method of DiMarco OR DiMarco in view of Pitts to include user input such as the audio command as taught by Pitts in order to provide the predictable results of providing a more patient specific algorithm that provides a more effective and customized therapy.
Conclusion
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792