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 .
Election/Restrictions
Newly submitted claim 82 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 8 recites feedback information comprising “unilateral throbbing cranial pain, sensory sensitivity to light, sound, and smell, nausea, and dysfunction of autonomic, cognitive, emotional, and motor systems in some cases,” which is different than the feedback information recited in claims 33-35, 74-76 and 80.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 82 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant's arguments, see pages 7-9, filed 12/10/2025, regarding claims 17-18, 20, 32-35, 67, and 71-81 under 35 U.S.C. 102 and 103 have been fully considered. Applicant argues on pages 8-9 that “Ganguly that the cited art fails to teach each and every element of the claims as presented herein,” and cites [0097],[0118] that indicate the stimulation of the trigeminal nerve to treat migraines which teaches away from the claimed invention. Applicant asserts on page 8 that “there is no hint or suggestion in Ganguly of a first peripheral nerve effector configured to be placed on a first skin surface proximate a median nerve of an arm or a wrist of a patient and a second peripheral nerve effector configured to be placed on a second skin surface proximate a radial nerve or an ulnar nerve of the arm or the wrist of the patient for treating a headache condition.” Applicant further asserts on page 9 that “paragraph [0105] of Ganguly is the only other mention of “migraine” in the entire document. In the first sentence of [0105] it is mentioned that “Various diseases and conditions may be treated by PNS combined with training and feedback using the devices, systems and algorithms described above”. Migraines are provided as one of the conditions that may be treated. There is no further description in [0105] of any device configuration used to treat migraine.” Examiner agrees that [0097] and [0118] are directed to the stimulation of the trigeminal nerve to treat migraines, however, [0105] of Ganguly is directed to the PNS stimulation of diseases and conditions such as migraines, and the following paragraph, [0106], specifies the stimulation of either the median or radial nerve for treating disease conditions, that being migraines. Therefore, the rejection is maintained.
Regarding the Provisional Nonstatutory Obviousness Double Patenting rejection arguments on page 9, filed 12/10/2024, since the applicant has amended the claims, the rejection is withdrawn.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 17-18, 20, 32-33, 35, 67, and 71-78 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Ganguly et al. (US 20200061378) (WO/2018/093765 IDS) (Hereinafter Ganguly) (citations are from US 20200061378).
Regarding claim 67, Ganguly teaches A wearable device for treating migraines using transcutaneous peripheral nerve stimulation ([0013] “A stimulator may be configured as a wearable stimulator that is configured to be worn on a subject's arm and/or wrist, (e.g., and configured to apply stimulation to one or more of the subject's radial, ulnar and median nerves).”), comprising:
a first peripheral nerve effector configured to be placed on a first skin surface proximate a median nerve of an arm or a wrist of a patient ([0089] “In FIG. 6A-6D the wrist band 250 incorporates one or more electrodes 255 to individually or collectively stimulate the three peripheral nerves of the arm, namely the radial, median and ulnar nerves.” [0134] “For multiple nerve stimulations (e.g., median, ulnar, radial), all nerves may be stimulated simultaneously or may be stimulated using a patterned train (e.g. sequential or any combination with variable temporal lags).”);
a second peripheral nerve effector configured to be placed on a second skin surface proximate a radial nerve of the arm or the wrist of the patient ([0089] “In FIG. 6A-6D the wrist band 250 incorporates one or more electrodes 255 to individually or collectively stimulate the three peripheral nerves of the arm, namely the radial, median and ulnar nerves.” [0134] “For multiple nerve stimulations (e.g., median, ulnar, radial), all nerves may be stimulated simultaneously or may be stimulated using a patterned train (e.g. sequential or any combination with variable temporal lags).”);
at least one biomedical sensor configured to provide feedback information, the at least one biomedical sensor located on a headband worn on a head of the patient ([0158] “The patient applies the stimulation device to wrist and puts on the headband EEG…Stimulation signals are sent to the control module while EEG data is received from the EEG monitor. The EEG data is used to modulate the stimulation in real time according to algorithm.”), and
a controller ([0161] “controller”) configured to:
transcutaneously deliver a first electrical stimulation signal to the first peripheral nerve effector to stimulate the median nerve ([0023] “electrical stimulation may be applied transdermally (e.g., through the skin)” [0134] “For multiple nerve stimulations (e.g., median, ulnar, radial), all nerves may be stimulated simultaneously or may be stimulated using a patterned train (e.g. sequential or any combination with variable temporal lags).”); and
transcutaneously deliver a second electrical stimulation signal to the second peripheral nerve effector to stimulate the radial nerve ([0023] “electrical stimulation may be applied transdermally (e.g., through the skin)” [0134] “For multiple nerve stimulations (e.g., median, ulnar, radial), all nerves may be stimulated simultaneously or may be stimulated using a patterned train (e.g. sequential or any combination with variable temporal lags).”);
wherein at least one of the first electrical stimulation signal or the second electrical stimulation signal are therapeutically effective to treat an episode of a migraine ([0105] “Various diseases and conditions may be treated by PNS combined with training and feedback using the devices, systems and algorithms described above. These include … migraines” [0106] “Various nerves may be targeted for treat disease conditions or to enhance performance. These include nerves of the upper limb such as radial nerve (all branches), median nerve”);
wherein if more episodes occur in one day, at least one of the first electrical stimulation signal or the second electrical stimulation signal can be increased by increasing an amplitude of the stimulation, duration of the stimulation, or number of treatment sessions (This limitation is conditional and does not occur when only one episode occurs in one day.).
“The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.” “The broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur.” Note the phrase, “if more episodes occur in one day” in claims 67 are conditional language, that is, if a condition precedent in a method claim is not met, the conditional steps recited in the claim are not required to be performed. The conditions of more episodes in one day may or may not reach not occur. As such, the broadest reasonable interpretation of such a method claim does not include the conditional step along with the steps proceeding the conditional step. See MPEP 2111.04(II).
Examiner notes that if only one migraine episode occurs, the condition is met, and therefore, the increased amplitude stimulation, duration, or treatments do not occur.
Regarding claim 17, Ganguly teaches wherein the first electrical stimulation signal and the second electrical stimulation signal comprise burst stimulation signals ([0016] “a controller may be configured to adjust the electrical stimulation by adjusting one or more of: intensity, current amplitude, frequency, duration, duty cycle, times/day, pulse duration, burst frequency, burst duration, or total treatment period.” See Fig. 15D).
Regarding claim 18, Ganguly teaches wherein the device is not configured to stimulate the upper arm of the patient ([0013] “A stimulator may be configured as a wearable stimulator that is configured to be worn on a subject's arm and/or wrist, (e.g., and configured to apply stimulation to one or more of the subject's radial, ulnar and median nerves).” Since the device can be wrist worn, it is not stimulating the upper arm.).
Regarding claim 20, Ganguly teaches wherein the first peripheral nerve effector and the second peripheral nerve effector are coupled together on a wearable band ([0013] “A stimulator may be configured as a wearable stimulator that is configured to be worn on a subject's arm and/or wrist, (e.g., and configured to apply stimulation to one or more of the subject's radial, ulnar and median nerves).” [0089] “the wrist band 250 incorporates one or more electrodes 255 to individually or collectively stimulate the three peripheral nerves”).
Regarding claim 32, Ganguly teaches wherein the feedback information comprises real-time feedback information ([0087] “The device comprises bipolar electrodes 202 as well as vibrotactile feedback sensors 203 to provide real-time feedback regarding (EEG or motor or movement) response to SES stimulation and task-errors during dexterity training.”).
Regarding claim 33, Ganguly teaches wherein the feedback information comprises autonomic nervous system activity of the patient (Abstract “Methods and apparatuses for sensory electrical stimulation of the peripheral nervous system [part of the ANS] to improve human motor function” [0087] “The device comprises bipolar electrodes 202 as well as vibrotactile feedback sensors 203 to provide real-time feedback regarding (EEG or motor or movement) response to SES stimulation [part of PNS] and task-errors during dexterity training.”).
Regarding claim 35, Ganguly teaches wherein the feedback information comprises EEG data of the patient ([0087] “The device comprises bipolar electrodes 202 as well as vibrotactile feedback sensors 203 to provide real-time feedback regarding (EEG or motor or movement) response to SES stimulation and task-errors during dexterity training.”).
Regarding claim 71, Ganguly teaches further comprising at least one biomedical sensor or data input source configured to provide feedback information, and wherein the controller is further configured to adjust at least one of the first electrical stimulation signal and the second electrical signal stimulation signal based on the feedback information ([0087] “The device comprises bipolar electrodes 202 as well as vibrotactile feedback sensors 203 to provide real-time feedback regarding (EEG or motor or movement) response to SES stimulation and task-errors during dexterity training.” [0044] “wherein the program causes a processor to measure a delta wave or theta wave component of an EEG from the biomarker monitor; and adjust the stimulation parameters based on the measured biomarker; and transmit the adjusted stimulation parameters to the stimulator”).
Regarding claim 72, Ganguly teaches wherein the at least one biomedical sensor or data input source comprises motion data relating to the patient ([0085] “software enables real-time feedback on motion during dexterity training.” [0108] “using analysis of phones integrated with motion sensors to analyze gait and provide feedback, placing motion sensors in critical locations along the lower extremities using adhesives or integrated into girdle/sleeves or using motion capture (using e.g., Microsoft Kinect).”).
Regarding claim 73, Ganguly teaches wherein the second peripheral nerve effector is configured to stimulate a radial nerve ([0106] “one embodiment may simultaneously stimulate the median, ulnar and/or radial nerves.”).
Regarding claim 74, Ganguly teaches wherein the EEG data comprises a first set of EEG data prior to a therapy session wherein the controller is configured to adjust at least one of the first electrical stimulation signal and the second electrical stimulation signal based on the first set of EEG data ([0138] “EEG recordings before/during/after stimulation [therapy session] are used to assess response to PNS” [0130] “This may be further modulated and optimized based on how people with similar EEG profiles and responses performed in the past.”).
Regarding claim 75, Ganguly teaches wherein the EEG data comprises a second set of EEG data during or after the therapy session, wherein the controller is configured to adjust at least one of the first electrical stimulation signal and the second electrical stimulation signal based on the second set of EEG data ([0158] “The phone communicates using Bluetooth low energy with the EEG monitor and the electrode control module. Stimulation signals are sent to the control module while EEG data is received from the EEG monitor. The EEG data is used to modulate the stimulation in real time according to algorithm.”).
Regarding claim 76, Ganguly teaches wherein an EEG sensor is located on an EEG headband, the EEG headband configured to transmit the EEG data to the controller ([0158] “The patient applies the stimulation device to wrist and puts on the headband EEG. She then opens an app on the phone which has previously uploaded data from last stimulation session and last training session. The server has revised the stimulation algorithm and pushed it back down to the app. She then starts a monitored stimulation session. The phone communicates using Bluetooth low energy with the EEG monitor and the electrode control module. Stimulation signals are sent to the control module while EEG data is received from the EEG monitor.”).
Regarding claim 77, Ganguly teaches wherein the first electrical stimulation signal and the second electrical stimulation signal are configured to disrupt a thalamocortical dysrhythmia associated with migraine ([0105] “Various diseases and conditions may be treated by PNS combined with training and feedback using the devices, systems and algorithms described above. These include stroke, pain, neuralgia, migraines” [0106] “Various nerves may be targeted for treat disease conditions or to enhance performance. These include nerves of the upper limb such as radial nerve (all branches), median nerve…one embodiment may simultaneously stimulate the median, ulnar and/or radial nerves.”). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious. Even though applicant has proposed or claimed the mechanism by which the disruption of thalamocortical dysrhythmia associated with migraines does not appear to distinguish the prior art teaching the same or nearly the same methods to achieve the same end result of stimulating an individual with migraines. Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145(II) and MPEP 2112.01.
Regarding claim 78, Ganguly teaches wherein the controller is configured to stimulate an orexinergic network by transcutaneously delivering the first electrical stimulation signal and the second electrical stimulation signal ([0107] “In the case of stroke, traumatic brain injury or other acquired brain injury with speech, language, dysphagia, upper-limb and lower-limb deficits, or cerebral palsy, the device may stimulate nerves of the upper limb (sensory and motor nerves C3-T2, including ulnar, median, radial,” Orexigenic network is associated with the health condition of eating habits and appetite. In this regard, dysphagia is a health condition associated with poor eating habits and the difficulty of swallowing, and therefore associated with the orexigenic network.). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious. Even though applicant has proposed or claimed the mechanism by which the stimulation of orexigenic network does not appear to distinguish the prior art teaching the same or nearly the same methods to achieve the same end result of stimulating dysphagia. Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145(II) and MPEP 2112.01.
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) 80-81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganguly et al. (US 20200061378) (WO/2018/093765 IDS) (Hereinafter Ganguly) in view of Matthews (US 10118049)(Hereinafter Matthews).
Claims 80, Ganguly teaches A wearable device for treating migraines using transcutaneous peripheral nerve stimulation ([0013] “A stimulator may be configured as a wearable stimulator that is configured to be worn on a subject's arm and/or wrist, (e.g., and configured to apply stimulation to one or more of the subject's radial, ulnar and median nerves).”), comprising:
a first peripheral nerve effector configured to be placed on a first skin surface proximate a median nerve of an arm or a wrist of a patient ([0089] “In FIG. 6A-6D the wrist band 250 incorporates one or more electrodes 255 to individually or collectively stimulate the three peripheral nerves of the arm, namely the radial, median and ulnar nerves.” [0134] “For multiple nerve stimulations (e.g., median, ulnar, radial), all nerves may be stimulated simultaneously or may be stimulated using a patterned train (e.g. sequential or any combination with variable temporal lags).”);
a second peripheral nerve effector configured to be placed on a second skin surface proximate a radial nerve of the arm or the wrist of the patient ([0089] “In FIG. 6A-6D the wrist band 250 incorporates one or more electrodes 255 to individually or collectively stimulate the three peripheral nerves of the arm, namely the radial, median and ulnar nerves.” [0134] “For multiple nerve stimulations (e.g., median, ulnar, radial), all nerves may be stimulated simultaneously or may be stimulated using a patterned train (e.g. sequential or any combination with variable temporal lags).”);
at least one biomedical sensor configured to provide feedback information, the at least one biomedical sensor located on a headband worn on a head of the patient ([0158] “The patient applies the stimulation device to wrist and puts on the headband EEG…Stimulation signals are sent to the control module while EEG data is received from the EEG monitor. The EEG data is used to modulate the stimulation in real time according to algorithm.”), and
a controller ([0161] “controller”) configured to:
transcutaneously deliver a first electrical stimulation signal to the first peripheral nerve effector to stimulate the median nerve ([0023] “electrical stimulation may be applied transdermally (e.g., through the skin)” [0134] “For multiple nerve stimulations (e.g., median, ulnar, radial), all nerves may be stimulated simultaneously or may be stimulated using a patterned train (e.g. sequential or any combination with variable temporal lags).”); and
transcutaneously deliver a second electrical stimulation signal to the second peripheral nerve effector to stimulate the radial nerve ([0023] “electrical stimulation may be applied transdermally (e.g., through the skin)” [0134] “For multiple nerve stimulations (e.g., median, ulnar, radial), all nerves may be stimulated simultaneously or may be stimulated using a patterned train (e.g. sequential or any combination with variable temporal lags).”);
wherein the controller is configured to adjust at least one of the first electrical stimulation signal and the second electrical stimulation signal based on the feedback information ([0044] “wherein the program causes a processor to measure a delta wave or theta wave component of an EEG from the biomarker monitor; and adjust the stimulation parameters based on the measured biomarker; and transmit the adjusted stimulation parameters to the stimulator”);
wherein at least one of the first electrical stimulation signal or the second electrical stimulation signal are therapeutically effective to treat an episode of a migraine ([0105] “Various diseases and conditions may be treated by PNS combined with training and feedback using the devices, systems and algorithms described above. These include … migraines” [0106] “Various nerves may be targeted for treat disease conditions or to enhance performance. These include nerves of the upper limb such as radial nerve (all branches), median nerve”);
wherein the controller is configured to adjust at least one of the first electrical stimulation signal and the second electrical stimulation signal based on the feedback information ([0107] “a diagnostic and/or combination diagnostic/stimulation device can be configured to measure a person's heart rate and galvanic skin response for improved estimation of the person's autonomic activity; this estimation of autonomic activity can in turn be used to adjust the stimulation applied as treatment, including but not limited to frequency of stimulation, coordination of bursting of stimulation, selected nerve target, duration of stimulation session, or the time of day stimulation is applied… can be analyzed by a hardware or software processor and combined to provide a more accurate estimation of sympathetic and/or parasympathetic activity” Examiner notes that the EEG signal can determine sympathetic and parasympathetic activity, which can also then be analyzed by the processor to determine the alteration in stimulation, similar to the use of heart rate and galvanic skin.);
wherein the feedback information comprises EEG data of the patient ([0107] “by an EEG headband”) at a resting state and EEG data of the patient at an aberrant state ([0068] “FIGS. 20A-20C shows changes in resting state EEG power across the subjects in a clinical study.” Examiner interprets an aberrant state is a state that is not normal.).
However, Ganguly does not explicitly teach the EEG data of the patient at an aberrant state indicating migraines. Matthews, in the same field of endeavor, teaches the treatment of migraines via stimulation of neurons (Abstract and Col. 2 lines 24-31), similar to the device of Ganguly, and further teaches wherein EEG data of the patient at an aberrant state indicates the symptoms that accompany migraines (Col. 11 lines 19-25 “The controller can average the data received from the EEG to produce a somatosensory evoked potential and to determine when a sphenopalatine ganglion block has been completed. The controller can automatically stop the stimulation of the neural cell when the sphenopalatine ganglion block is completed” Examiner notes that determining when sphenopalatine ganglion block is completed occurs when the migraine has been fully treated. In other words, the EEG monitors when user has a migraine until the migraine ends.) to treat headache symptoms (Col. 11 lines 46-48). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Gunguly, with the EEG data of the patient at an aberrant state indicating migraines of Matthews, because such a modification would allow to treat headache symptoms.
Regarding claim 81, Ganguly teaches wherein the controller is configured to stimulate an orexinergic network by transcutaneously delivering the first electrical stimulation signal and the second electrical stimulation signal ([0107] “In the case of stroke, traumatic brain injury or other acquired brain injury with speech, language, dysphagia, upper-limb and lower-limb deficits, or cerebral palsy, the device may stimulate nerves of the upper limb (sensory and motor nerves C3-T2, including ulnar, median, radial,” Orexigenic network is associated with the health condition of eating habits and appetite. In this regard, dysphagia is a health condition associated with poor eating habits and the difficulty of swallowing, and therefore associated with the orexigenic network.). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious. Even though applicant has proposed or claimed the mechanism by which the stimulation of orexigenic network does not appear to distinguish the prior art teaching the same or nearly the same methods to achieve the same end result of stimulating dysphagia. Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145(II) and MPEP 2112.01.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganguly et al. (US 20200061378) (WO/2018/093765 IDS) (Hereinafter Ganguly) in view of Ziv (US 20180028809)(Hereinafter Ziv).
Regarding claim 34, Ganguly teaches the invention of claim 1. However, Ganguly does not teach a feedback information comprising HRV. Ziv, in the same field of endeavor, teaches the neurostimulation of the skin via electrodes ([0008]), similar to the device of Gungly, and further teaches wherein the feedback information comprises heart rate variability ([0098] “According to some embodiments, processing circuitry 126 may comprise loop feedback circuitry (not shown), configured to adjust inputs (e.g. stimulation signals) as a function of outputs (e.g. real-time HRV values).”) to adjust the stimulation in real-time ([0098]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Gunguly, with the feedback information comprising HRV of Ziv, because such a modification would allow to adjust the stimulation in real-time.
Claim(s) 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganguly et al. (US 20200061378) (WO/2018/093765 IDS) (Hereinafter Ganguly) in view of Simon et al. (US 20110230701)(IDS)(Hereinafter Simon).
Regarding claim 79, Ganguly teaches the invention of claim 1. However, Ganguly does not teach a respiratory cycle to activate stimulation. Simon, in the same field of endeavor, teaches the nerve stimulation for treating migraines and headaches (Abstract), similar to the device of Ganguly, and further teaches wherein the controller is arranged to receive measurements from a sensor that detects events or phases of a respiratory cycle; wherein the controller is configured to activate at least the first electrical stimulation signal or the second electrical stimulation signal in phase with a portion of the respiratory cycle by measurements from the sensor ([0049] “electrical stimulation on the surface of the neck may co-stimulate the phrenic nerve that is involved with the control of respiration, the patient hiccups and does not breathe normally, resulting in "a patient sense of incongruity and displeasure." … to modulate the timing and intensity of the electrical stimulation at the neck as a function of the respiratory phase, in such a way that the undesirable respiratory effects are minimized.”) to minimize undesirable respiratory effects ([0049]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Gunguly, with the respiratory cycle to activate stimulation of Simon, because such a modification would allow to minimize undesirable respiratory effects.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796