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 .
Amendment
This action is in response to the Amendment filed on 10/3/2025.
Claims 1-18 are pending.
Response to Arguments
Applicant's arguments with respect to claims 1-18 have been considered but are moot in view of the new grounds of rejection as necessitated by the amendment.
Claim Rejections under 35 U.S.C. 102 - U.S. Patent Publication No. 2006/0247729 ("Tehrani").
Claim 1 has been amended to replace the term "oral appliance" with the language "a mouth guard configured for being worn by the patient."
Applicant argues that the flow sensor 56 disclosed in Tehrani is not a mouth guard that can be worn by a patient. Thus, Applicant submits that independent claim 1, as well as the claims depending therefrom (claims 2-4, 6, 8, and 17) are not anticipated by Tehrani, and as such, respectfully requests the withdrawal of the §102 rejection of these claims. they further argue that dependent claim 17 also recites a mouthguard.
Upon review of the claim amendments and the prior art as applied, the rejection under 35 U.S.C. 102 has now been withdrawn. However, upon further search and consideration, the claims are now rejected as discussed below in the current office action.
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 1-4, 6, 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Tehrani et al (U.S. Patent Application Publication Number: US 2006/0247729 A1, hereinafter “Tehrani”) in view of Bolea et al (U.S. Patent Application Publication Number: US 2015/0224307 A1, hereinafter “Bolea’307”) OR Lattner et al (U.S. Patent Number: US 6212435 B1, hereinafter “Lattner”) OR Bolea et al (U.S. Patent Number: US 7809442 B2, hereinafter “Bolea” – PREVIOUSLY CITED).
Regarding claims 1, 2 and 17, Tehrani teaches a neurostimulation system for treating obstructive sleep apnea (OSA) (e.g. [0014], [0015],[0064]) in a patient, comprising:
a nerve cuff electrode (e.g. 21’,22’ Fig1B, [0076]) carrying at least one electrode contact; Fig. 20E)
an implantable neurostimulator (e.g. 100’ Fig1B, [0076]) electrically coupled to the at least one electrode contact of the nerve cuff electrode and configured for delivering an electrical pulse train to the at least one electrode contact;
Tehrani teaches a flow sensor that is configured for being inserted in an oral cavity of the patient for measuring a physiological parameter (i.e. flow sensor e.g. 56 Fig1A, [0069], [0073]: A flow sensor 56 positioned in the mouth for sensing physiological artifacts that are caused by respiration) of the patient indicative of an efficacy of the delivered electrical pulse train in synchronization with a respiratory cycle based on the sensed physiological artifacts in treating the OSA (e.g. Figs 17B, 18A, B, [0140], [0142]).
They do not specifically teach that the flow sensor is a mouthguard.
Bolea’307 teaches a system and method of treating obstructive sleep apnea and detecting mouth airflow using a strip or mask interacting with the mouth (both of which are considered as a mouthguard since applicant has not provided any structure to the claimed mouthguard and the specifications also do not provide any description of any specific mouthguard structure) to measure airflow (e.g. [0143], Abstract). Lattner teaches another system and method for treating obstructive sleep apnea and teaches that it is well known for a respiration sensor to be located in a mouthguard (e.g. Fig. 6 Col. 18, lines 13-25). Bolea is another teaching that teaches an non-invasive oral appliance 530 comprising a sensor placed in a mouth and communicating with an implantable system to treat obstructive sleep apnea (e.g. Figs. 53-56, Col. 38 lines 52-col. 39 line 45). 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 flow sensor placed in in the oral cavity as taught by the teachings of Tehrani to be placed on a strip interacting with the mouth as taught by Bolea’307 OR the flow sensor of Tehrani be placed in mouthguard as taught by Lattner OR the flow sensor of Tehrani be placed on a mouthpiece as taught by Bolea in order to provide the predictable results of making the device more noninvasive and user-friendly.
Regarding claim 3, “modified” Tehrani teaches the claimed invention as discussed above and Tehrani further teaches the implantable neurostimulator is configured for determining the next projected onset of an inspiratory phase of the respiratory cycle based on the sensed physiological artifacts, and delivering the electrical pulse train to the at least one electrode contact immediately before, at, or right after the next projected onset of the inspiratory phase of the respiratory cycle (e.g. [0082], Figs.17A-E. 18A-F).
Regarding claim 4, “modified” Tehrani teaches the claimed invention as discussed above and Tehrani further teaches the implantable neurostimulator is configured for storing data representative of the physiological artifacts sensed by the sensing circuitry (e.g. [0082]).
Regarding claim 6, “modified” Tehrani teaches the claimed invention as discussed above and Tehrani further teaches a clinician programmer that is configured for: selecting the at least one electrode contact from a plurality of electrode contacts, and transcutaneously communicating with the implantable neurostimulator, and programming the implantable neurostimulator to deliver the electrical pulse train to the selected at least one electrode contact (e.g. [0074], [0082], [0093]: an external programmer that telemetrically communicates with the processor and instructs the processor to cause stimulation pulses to be delivered and the responses to be measured).
Regarding claim 8, “modified” Tehrani teaches the claimed invention as discussed above and Tehrani further teaches an external charger configured for inductively and transcutaneously charging the implantable neurostimulator (e.g. [0077],[0079], [0095]).
Claims 5, 7, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Tehrani et al (U.S. Patent Application Publication Number: US 2006/0247729 A1, hereinafter “Tehrani”) in view of Bolea et al (U.S. Patent Application Publication Number: US 2015/0224307 A1, hereinafter “Bolea’307”) OR Lattner et al (U.S. Patent Number: US 6212435 B1, hereinafter “Lattner”) OR Bolea et al (U.S. Patent Number: US 7809442 B2, hereinafter “Bolea” – PREVIOUSLY CITED) and further in view of Bolea et al (U.S. Patent Number: US 7809442 B2, hereinafter “Bolea” – PREVIOUSLY CITED).
Regarding claim 5, “modified” Tehrani teaches the claimed invention as discussed above except for the electrical pulse train having an initial, preconditioning current or voltage amplitude and a subsequent higher stimulating current or voltage amplitude.
In a similar field of endeavor, Bolea teaches that it is well known to provide an electrical pulse train that has an initial, preconditioning current or voltage amplitude (e.g. col. 28, line 40-col. 29, line 6; col. 39, lines 35-58) and a subsequent higher stimulating current or voltage amplitude (e.g. col. 28, lines 40-59, for controlling the stimulus based on obtained feedback). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Tehrani in view of Bolea’307 OR Lattner OR Bolea to have an initial preconditioning amplitude and a high stimulation current or voltage amplitude as taught by Bolea in order to provide the predictable results of providing a more effective therapy.
Regarding claim 7, “modified” Tehrani teaches the claimed invention as discussed above and Tehrani further teaches that the external device 140 may take or operate for patient use (i.e. as a patient programmer e.g. [0094]) and is configured for: transcutaneously communicating with the implantable neurostimulator (e.g. [0093]). They do not specifically teach that the patient programmer is configured for toggling the implantable neurostimulator between an OFF position and an ON position, such that in the OFF position, no stimulation is delivered to the at least one electrode contact.
In a similar field of endeavor, Bolea teaches that it is well known to provide a patient programmer that is configured for toggling the implantable neurostimulator between an OFF position and an ON position, such that in the OFF position, no stimulation is delivered to the at least one electrode contact (e.g. Col. 4 lines 18-37). 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 teachings of Tehrani in view of Bolea’307 OR Lattner OR Bolea to have an ON/OFF switch for toggling the implantable neurostimulator between an OFF position and an ON position, such that in the OFF position, no stimulation is delivered to the at least one electrode contact as taught by Bolea in order to provide the predictable results of having a more user-friendly device that can be easily controlled by the patient and used as and when necessary.
Regarding claim 15, “modified” Tehrani teaches the claimed invention as discussed above and “modified Tehrani” further teaches that the mouthguard comprises a flow sensor 56 to measure airway pressure (e.g. [0069], [0073]) as the physiological parameter, they do not specifically teach that the mouthguard comprises an EMG sensor that measures an electrical potential generated by the muscle cells of the tongue in response to the electrical stimulation of a hypoglossal nerve.
Bolea shows measuring a physiological parameter that comprises an electrical potential generated by the muscle cells of a tongue of the patient in response to electrical stimulation of a hypoglossal nerve, wherein electrical stimulation of the hypoglossal nerve triggers the movement of the tongue that is being measured (e.g. col. 39, lines 36-44, col. 37, lines 52-54; col. 3, lines 35-37). 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 mouthguard in the teachings of Tehrani in view of Bolea’307 OR Lattner OR Bolea to also include an EMG sensor to measure signals from the tongue as taught by Bolea in order to provide the predictable results of improving efficacy of the therapy.
Regarding claim 18, “modified” Tehrani teaches the claimed invention as discussed above except for the mouthguard being wirelessly coupled to the implantable neurostimulator.
In a similar field of endeavor, Bolea teaches wireless coupling between implanted as well as external respiratory sensors and an implanted neurostimulator (e.g. Col. 7 lines 42-45). 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 teachings of Tehrani in view of Bolea’307 OR Lattner OR Bolea to have a wireless coupling between the mouthguard sensor and the implanted neurostimulator in order to provide the predictable results of ease of implantation.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tehrani et al (U.S. Patent Application Publication Number: US 2006/0247729 A1, hereinafter “Tehrani”) in view of Bolea et al (U.S. Patent Application Publication Number: US 2015/0224307 A1, hereinafter “Bolea’307”) OR Lattner et al (U.S. Patent Number: US 6212435 B1, hereinafter “Lattner”) OR Bolea et al (U.S. Patent Number: US 7809442 A1, hereinafter “Bolea”) and further in view of Ni (U.S. Patent Number: US 8,983,572 B2, hereinafter “Ni”- PREVIOUSLY CITED).
Regarding claim 9, “modified” Tehrani teaches the claimed invention as discussed above and Tehrani further teaches a clinician programmer (e.g. 140 [0093],[0094]) configured for computing (e.g. [0093] : the programmer 140 comprises a computer 32), and configured for controlling and programming the neurostimulator to determine therapeutic efficacy (e.g. [0093] - As discussed above, the measured physiological parameter is indicative of efficacy of the stimulation treatment). Tehrani does not specifically teach computing a therapy score indicative of an efficacy of the at least one electrode contact based on the measured physiological parameter.
In a similar field of endeavor, Ni teaches that it is known in the art to compute a score based on sensed physiological data (e.g. Figs. 2-3; col. 5, lines 8-26; col. 9, lines 8-26) as a useful tool in order to determine the state of the patient and if stimulation is appropriate for the computed score (e.g. col. 9, lines 25-34). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the processor in the teachings of Tehrani in view of Bolea’307 OR Lattner OR Bolea with the teaching of Ni, and computing for a therapy score of the at least one electrode contact based on the measured physiological parameter as taught by Ni for the purpose of quantifying the effect of the measured physiological data on OSA of the patient, to determine if stimulation is appropriate based on the computed therapy score.
Regarding claim 10, “modified” Tehrani teaches the claimed invention as discussed above and Tehrani further teaches the claimed invention as discussed above and teaches wherein the system determines efficiency of the patient’s breathing based on measuring the physiological parameter and quality of the inspiratory phase in order to observe efficiency of the breathing as discussed. Tehrani also shows measuring air flow using an oral sensor during at least several respiratory cycles, to extract the respiration data while sleeping for the treatment of OSA (Figs. 17, 18), which provides the closed-loop feedback to predict the inspiratory phase and delivery appropriate stimulation.
In a similar field of endeavor, Ni teaches that it is known in the art to compute a score based on sensed physiological data (e.g. Figs. 2-3; col. 5, lines 8-26; col. 9, lines 8-26) as a useful tool in order to determine the state of the patient and if stimulation is appropriate for the computed score (e.g. col. 9, lines 25-34). 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 the teachings of Tehrani in view of Bolea’307 OR Lattner OR Bolea to compute a therapy score based on the determined efficiency of each inspiration phase in at least several respiratory cycles, and it would have been obvious to compute the therapy score throughout each inspiration phase in the respiratory cycle for the purpose of determining appropriate stimulation and if adjustments to the therapy are needed as taught by Ni to improve the quality of breathing.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Tehrani et al (U.S. Patent Application Publication Number: US 2006/0247729 A1, hereinafter “Tehrani”) in view of Bolea et al (U.S. Patent Application Publication Number: US 2015/0224307 A1, hereinafter “Bolea’307”) OR Lattner et al (U.S. Patent Number: US 6212435 B1, hereinafter “Lattner”) OR Bolea et al (U.S. Patent Number: US 7809442 b2, hereinafter “Bolea”) and Ni (U.S. Patent Number: US 8,983,572 B2, hereinafter “Ni”- PREVIOUSLY CITED) and further in view of Meadows et al (U.S. Patent Application Publication Number: US 2010/0198103 A1, hereinafter “Meadows”- PREVIOUSLY CITED).
Regarding claim 11, “modified” Tehrani in view of Ni teaches the claimed invention as discussed above and teaches that the mouthguard comprises a flow sensor 56 to measure airway pressure (e.g. [0069], [0073]) as the physiological parameter and also shows the physiological parameter measured is used to coordinate effective stimulation delivery according to respiration as discussed above. Tehrani does not specifically teach that the mouthguard comprises one or more inertial sensors that measure movement of the tongue in response to electrical stimulation of the hypoglossal nerve, and that the clinician programmer is configured for determining the extent to which the tongue protrudes based on the measured physiological parameter from the one or more inertial sensors and computing a therapy score based on the determined extent to which the tongue protrudes.
In a similar field of endeavor, Meadows teaches neural stimulation to treat sleep apnea (e.g. [0004]) to target the hypoglossal nerve as an effective treatment for OSA (e.g. [0005]). Meadows teaches measuring the effect of delivered electrical stimulation (e.g. [0042]) comprising using one or more inertial sensors to measure tongue movement, including tongue protrusion wherein the inertial sensors comprises an accelerometer (e.g. [0044]). The measured stimulus effects are collected and used to program electrical stimulation delivery to the hypoglossal nerve to treat the OSA (e.g. [0051], [0054]), wherein said electrical stimulation delivery controls the tongue (e.g. [0055]). Meadows is relied upon for teaching a specific type of sensor that measures tongue movement in response to stimulation delivered to the hypoglossal nerve. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the mouth guard of Tehrani in view of Bolea’307 OR Lattner OR Bolea and Ni to also comprise a known sensor that measures tongue movement in response to stimulation delivered to the hypoglossal nerve, such as the accelerometer taught by Meadows, which measures tongue protrusion in response to the stimulation and said measurement is used to determine therapy effect on tongue protrusion. The modification would provide Meadows’ benefit of treating OSA according to how the tongue is responding (including tongue protrusion) to applied stimulus patterns and modify the stimulus patterns in order to achieve a desired tongue movement when treating the OSA.
Further that Ni teaches that it is known in the art to compute a score based on sensed physiological data (e.g. Figs. 2-3; col. 5, lines 8-26; col. 9, lines 8-26) as a useful tool in order to determine the state of the patient and if stimulation is appropriate for the computed score (e.g. col. 9, lines 25-34). 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 the teachings of Tehrani in view of Bolea’307 OR Lattner OR Bolea and Ni in view of Meadows and compute the therapy score based on the measured signal for the purpose of determining appropriate stimulation and if adjustments to the therapy are needed to improve the quality of breathing.
Regarding claims 12-14, “modified” Tehrani teaches the claimed invention as discussed above and teaches that the mouthguard comprises a flow sensor 56 to measure airway pressure (e.g. [0069], [0073]) as the physiological parameter and also shows the physiological parameter measured is used to coordinate effective stimulation delivery by delivering an electrical pulse train to the at least one electrode contact according to respiration as discussed above. Tehrani also teaches a clinician programmer wirelessly coupled to the implantable neurostimulator (e.g. [0074], [0082], [0093]). Tehrani does not specifically teach that that the mouthguard comprises one or more inertial sensors that measure movement of the tongue in response to electrical stimulation of the hypoglossal nerve, and that the clinician programmer is configured for computing a therapy score based on the signals from the inertial sensor.
In a similar field of endeavor, Meadows teaches neural stimulation to treat sleep apnea (e.g. [0004]) to target the hypoglossal nerve as an effective treatment for OSA (e.g. [0005]). Meadows teaches measuring the effect of delivered electrical stimulation (e.g. [0042]) comprising using one or more inertial sensors to measure tongue movement, including tongue protrusion wherein the inertial sensors comprise an accelerometer (e.g. [0044]). The measured stimulus effects are collected and used to program electrical stimulation delivery to the hypoglossal nerve to treat the OSA (e.g. [0051], [0054]), wherein said electrical stimulation delivery controls the tongue (e.g. [0055]). Meadows is relied upon for teaching a specific type of sensor that measures tongue movement in response to stimulation delivered to the hypoglossal nerve. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the mouthguard of Tehrani in view of Bolea’307 OR Lattner OR Bolea to also comprise a known sensor that measures tongue movement in response to stimulation delivered to the hypoglossal nerve, such as the accelerometer taught by Meadows, which measures tongue protrusion in response to the stimulation and said measurement is used to determine therapy effect on tongue protrusion. The modification would provide Meadows’ benefit of treating OSA according to how the tongue is responding (including tongue protrusion) to applied stimulus patterns and modify the stimulus patterns in order to achieve a desired tongue movement when treating the OSA.
Further Ni teaches that it is known in the art to compute a score based on sensed physiological data (e.g. Figs. 2-3; col. 5, lines 8-26; col. 9, lines 8-26) as a useful tool in order to determine the state of the patient and if stimulation is appropriate for the computed score (e.g. col. 9, lines 25-34). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tehrani in view of Bolea’307 OR Lattner OR Bolea and Meadows and compute the therapy score based on the measured signal for the purpose of determining appropriate stimulation and if adjustments to the therapy are needed to improve the quality of breathing.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Tehrani et al (U.S. Patent Application Publication Number: US 2006/0247729 A1, hereinafter “Tehrani”) in view of Bolea et al (U.S. Patent Application Publication Number: US 2015/0224307 A1, hereinafter “Bolea’307”) OR Lattner et al (U.S. Patent Number: US 6212435 B1, hereinafter “Lattner”) OR Bolea et al (U.S. Patent Number: US 7809442 B2, hereinafter “Bolea”) and Bolea et al (U.S. Patent Number: US 7809442 B2, hereinafter “Bolea” – PREVIOUSLY CITED) and further in view of Ni (U.S. Patent Number: US 8,983,572 B2, hereinafter “Ni”- PREVIOUSLY CITED).
Regarding claim 16, “modified” Tehrani in view of Bolea teaches the claimed invention as discussed above, but they do not specifically teach that the clinician programmer is configured to compute a therapy score based on signals output by the electromyographic sensor.
Ni teaches that it is known in the art to compute a score based on sensed physiological data (Figs. 2-3; col. 5, lines 8-26; col. 9, lines 8-26) as a useful tool in order to determine the state of the patient and if stimulation is appropriate for the computed score (col. 9, lines 25-34). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the clinician programmer Tehrani in view of Bolea’307 OR Lattner OR Bolea and Bolea with the teaching of Ni, and computing a therapy score based on the measured physiological parameter as taught by Ni for the purpose of quantifying the effect of the measured physiological data on OSA of the patient, to determine if stimulation is appropriate based on the computed therapy score, based on signals output by the physiological parameter measured by the EMG sensor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lee et al (U.S. Patent Application Publication Number: US 2005/0061320 A1, hereinafter “Lee”) teaches sensors being placed in a mouthguard (i.e. mouth pieces) and communicating with an implantable system for treating a patient (e.g. [0063]).
Applicant's amendment necessitated the new grounds 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.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792