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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 5/26/2026 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4-12, 14, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Wernicke et al. (US 5,571,150, hereinafter “Wernicke”) in view of Mulrooney (US 2019/0134380, hereinafter “Mulrooney”).
In regards to claim 4, Wernicke discloses a method for increasing a consciousness level of a patient (abstract), the method comprising:
via a nasal or oral cavity, positioning a conductive element of a stimulation device at a treatment site in a lumen of an upper gastrointestinal tract of the patient (Fig. 2; col. 3, lines 53-58);
while the conductive element is positioned at the treatment site, stimulating a sensory nerve proximate the lumen (col. 3, lines 53-58, “electrically stimulate the vagus nerve”); and
in response to stimulating the sensory nerve, improving a consciousness level of the patient (col. 3, lines 53-58; abstract).
While Wernicke specifically notes stimulating the vagus nerve, Wernicke does not expressly disclose that the treatment site is in a lumen of a pharynx of the patient. However, Mulrooney in the same field of endeavor of neural stimulation teaches providing vagal nerve stimulation to the patient from a lumen of a pharynx of the patient (par. 0019) to provide the predictable results of overcoming the effects of tissue trauma and/or atrophy and/or re-establish dormant neurological pathways via vagal stimulation, and the presence of a ventilation tube provides a means to safely mechanically ventilate the patient, should this be needed (par. 0029).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wernicke by providing vagal nerve stimulation to the patient from a lumen of a pharynx of the patient to provide the predictable results of overcoming the effects of tissue trauma and/or atrophy and/or re-establish dormant neurological pathways via vagal stimulation, and the presence of a ventilation tube provides a means to safely mechanically ventilate the patient, should this be needed.
In regards to claim 5, stimulating the sensory nerve excites central nervous system regions associated with consciousness (col. 1, line 47 to col. 2, line 13).
In regards to claim 6, the sensory nerve includes the vagus nerve (col. 1, lines 47-50).
In regards to claim 7, Wernicke’s modified invention discloses wherein the sensory nerve includes the glossopharyngeal nerve (Mulrooney at par. 0019) to provide the same predictable results as set forth above.
In regards to claim 8, the sensory nerve comprises a sensorimotor nerve (col. 1, lines 47-50; see attached Wikipedia “Vagus nerve” reference for evidence that the vagus nerve is a sensorimotor nerve).
In regards to claim 9, stimulating the sensory nerve drives organizational changes and/or excitability level changes in the brain (col. 1, line 47 to col. 2, line 13; the stimulation drives excitability level changes as measured by EEG).
In regards to claim 10, improving the consciousness level of the patient comprises improving at least one of eye opening, verbal response, motor response, or autonomic response of the patient (col. 6, lines 59-67).
In regards to claim 11, improving the consciousness level of the patient comprises improving at least one of a cortical connectivity parameter, a cerebral metabolism parameter, a cortical excitability parameter, a clinical scoring system score (col. 6, lines 59-67; Glasgow coma scale), a brainstem reflex parameter, a biomarker, or a task-based fMRI parameter of the patient.
In regards to claim 12, improving the consciousness level of the patient comprises improving a score of the patient on a clinical scoring system comprising at least one of a Coma Recovery Scale - Revised score, a Glasgow Coma Scale score (col. 6, lines 59-67; Glasgow coma scale), a Full Outline of UnResponsiveness score, a Motor Behavior Tool - Revised score, or a World Federation of Neurological Societies score.
In regards to claim 14, Wernicke’s modified invention includes positioning the conductive element of the stimulation device in the lumen of the pharynx of the patient comprises positioning the conductive element within the oropharynx and/or the laryngopharynx (Mulrooney at abstract) to provide the same predictable results as set forth above.
In regards to claim 22, Wernicke’s modified invention discloses wherein stimulating the sensory nerve drives organizational changes in the brain (Mulrooney at pars. 0019 and 0025) to provide the same predictable results as set forth above.
In regards to claim 24, improving the consciousness level of the patient comprises improving at least one of a brainstem reflex parameter, a biomarker (col. 6, lines 46-67, EEG parameters serve as biomarkers and the Glasgow scale includes several biomarkers), or a task- based fMRI parameter of the patient.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as obvious over Wernicke and Mulrooney. Wernicke discloses the essential features of the claimed invention, including providing preferred stimulation parameters of a frequency between about 1 Hz and about 200 Hz (Table I), an amplitude between about 1 mA and about 50 mA (Table I), and a pulse width between about 200 µS and about 1 mS (Table I). Further, the disclosure of providing the stimulation at 0.1V (col. 6, line 3), 0.5ms pulse width (Table I), current of 1.5mA (Table I), frequency of 20 Hz (Table I), and treatment period of 300 sec. appears to provide a total energy delivered to the sensory nerve during a treatment session being less than 3 J or 8 J (450 µJ), thus necessarily reading on these claim limitations. Alternatively and additionally, Wernicke recognizes that the parameters providing this total energy are results-effective variables, and it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wernicke by providing this total energy to yield no more than predictable results.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wernicke and Mulrooney, further in view of Bassi et al. (US 2019/0038894, hereinafter “Bassi”). Wernicke discloses the essential features of the claimed invention except for wherein the stimulation device includes a feeding tube having an extracorporeally positioned proximal end and a distal end positioned within a gastrointestinal tract of the patient, and wherein the distal end of the feeding tube remains positioned in the patient's gastrointestinal tract while stimulating; wherein positioning the conductive element of the stimulation device in the lumen of the pharynx of the patient comprises positioning the conductive element in apposition with a posterior wall of the pharynx; or wherein positioning the conductive element of the stimulation device in the lumen of the pharynx of the patient comprises positioning the conductive element in apposition with at least one of an anterior wall of the pharynx, a lateral wall of the pharynx, or a medial wall of the pharynx. However, Bassi in the same field of endeavor of esophageal electrical stimulation (par. 0010) teaches a stimulation system wherein the stimulation device includes a feeding tube having an extracorporeally positioned proximal end and a distal end positioned within a gastrointestinal tract of the patient, and wherein the distal end of the feeding tube remains positioned in the patient's gastrointestinal tract while stimulating (Fig. 1B; par. 0055) to provide the predictable results of allowing for administration of food or medicine without having to disturb the placement the electrical treatment device (par. 0055); wherein positioning the conductive element of the stimulation device in the lumen of the pharynx of the patient comprises positioning the conductive element in apposition with a posterior wall of the pharynx (Fig. 1B, par. 0060); and wherein positioning the conductive element of the stimulation device in the lumen of the pharynx of the patient comprises positioning the conductive element in apposition with at least one of an anterior wall of the pharynx, a lateral wall of the pharynx, or a medial wall of the pharynx (Fig. 1B, par. 0060) to provide the predictable results of accurately targeting the intended neural stimulation site (par. 0060). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wernicke by providing a stimulation system wherein the stimulation device includes a feeding tube having an extracorporeally positioned proximal end and a distal end positioned within a gastrointestinal tract of the patient, and wherein the distal end of the feeding tube remains positioned in the patient's gastrointestinal tract while stimulating to provide the predictable results of allowing for administration of food or medicine without having to remove or insert the electrical treatment device; wherein positioning the conductive element of the stimulation device in the lumen of the pharynx of the patient comprises positioning the conductive element in apposition with a posterior wall of the pharynx; and wherein positioning the conductive element of the stimulation device in the lumen of the pharynx of the patient comprises positioning the conductive element in apposition with at least one of an anterior wall of the pharynx, a lateral wall of the pharynx, or a medial wall of the pharynx to provide the predictable results of accurately targeting the intended neural stimulation site.
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wernicke and Mulrooney, further in view of Simon et al. (US 2022/0040473, hereinafter “Simon”). Wernicke discloses the essential features of the claimed invention including wherein stimulation energy delivered to the sensory nerve has a frequency between about 1 Hz and about 200 Hz (Table I), an amplitude between about 1 mA and about 50 mA (Table I), and a pulse width between about 200 µS and about 1 mS (Table I). Wernicke does not expressly disclose a current density less than 5 mA/cm2 or 2 mA/cm2.However, Simon in the same field of endeavor of electrical therapy teaches providing a current density at less than 5 mA/cm2 or 2 mA/cm2 (par. 0104) to provide the predictable results of a current density that less than the limit for tolerable sensation (par. 0104). Further, it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wernicke by providing this current density to provide the predictable results of a current density that less than the limit for tolerable sensation and yield no more than predictable results.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Wernicke and Mulrooney, further in view of Osorio (US 2012/0298105, hereinafter “Osorio”). Wernicke’s modified invention discloses the essential features of the claimed invention, but does not expressly disclose wherein improving the consciousness level of the patient comprising improving an autonomic response of the patient. However, Osorio in the same field of endeavor of electrical neural stimulation teaches determining autonomic response as an indicator of consciousness level of a patient to provide the predictable results of accurately monitoring and logging factors that influence changes in body organ state or activity (par. 0035). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Wernicke by determining autonomic response as an indicator of consciousness level of a patient to provide the predictable results of accurately monitoring and logging factors that influence changes in body organ state or activity.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Wernicke and Mulrooney, and further in view of Rigaux (US 2018/0056059, hereinafter “Rigaux”). Wernicke’s modified invention discloses the essential features of the claimed invention, but does not expressly disclose that improving the consciousness level of the patient comprises improving a score of the patient on a clinical scoring system comprising at least one of a Coma Recovery Scale - Revised score, a Full Outline of UnResponsiveness Score, a Motor Behavior Tool - Revised score, or a World Federation of Neurological Societies score. However, Rigaux in the same field of endeavor of treating consciousness disorders teaches determining consciousness via that Coma Recovery Scale Revised (CRS-R) to provide the predictable results of another accurate indicator of consciousness level (par. 0040). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Wernicke by determining consciousness via that Coma Recovery Scale Revised (CRS-R) to provide the predictable results of another accurate indicator of consciousness level.
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Wernicke and Mulrooney, and further in view of Libbus et al. (US 8,301,239, hereinafter “Libbus”). Wernicke’s modified invention discloses the essential features of the claimed invention including monitoring data characterizing a consciousness parameter, but does not expressly disclose the steps of applying electrical stimulation energy to the treatment site; obtaining first data characterizing a consciousness parameter of the patient in response to applying electrical stimulation energy to the treatment site; obtaining second data characterizing the consciousness parameter of the patient; comparing the consciousness parameter of the first data to the consciousness parameter of the second data; and based on a value of the consciousness parameter of the first data exceeding a value of the consciousness parameter of the second data, stimulating the sensory nerve proximate the lumen; wherein the second data comprises a predetermined threshold value; or wherein the second data comprises baseline data collected from the patient.
However, Libbus in the same field of endeavor of GI tract neural stimulation teaches applying electrical stimulation energy to the treatment site; obtaining first data characterizing a response to applying electrical stimulation energy to the treatment site; obtaining second data characterizing the parameter of the patient; comparing the parameter of the first data to the parameter of the second data; and based on a value of the parameter of the first data exceeding a value of the parameter of the second data, stimulating the nerve (col. 7, lines 58-66); and wherein the second data comprises a predetermined threshold value (“upper or lower boundary”) to provide the predictable results of accurately reducing or increasing stimulation intensity as appropriate to maintain the measured parameter within an upper and lower boundary (col. 7, lines 58-66). Further, it is well-known in the art to provide closed-loop control limits based on baseline data collected from the patient to provide the predictable results of personalized control of therapy.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Wernicke by applying electrical stimulation energy to the treatment site; obtaining first data characterizing a response to applying electrical stimulation energy to the treatment site; obtaining second data characterizing the parameter of the patient; comparing the parameter of the first data to the parameter of the second data; and based on a value of the parameter of the first data exceeding a value of the parameter of the second data, stimulating the nerve; and wherein the second data comprises a predetermined threshold value to provide the predictable results of accurately reducing or increasing stimulation intensity as appropriate to maintain the measured parameter within an upper and lower boundary; and to provide closed-loop control limits based on baseline data collected from the patient to provide the predictable results of personalized control of therapy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhao et al. (US 2010/0010556 at par. 0054) is one of many teachings of setting a closed-loop control limit via a baseline collected from a patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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