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 .
Claim Rejections - 35 USC § 102
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 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)(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) 1-2, 5-6, 8-10, 14-15, 20, and 22-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20120239111 A1 to McCreery (hereinafter “McCreery”).
Regarding Claim 1, McCreery teaches a method comprising (see Abstract: “an apparatus, a system and a method for the treatment of obstructive sleep apnea”):
monitoring a recipient's tongue position while the recipient is asleep (see Para 13: “a sensor to monitor the position of a tongue and/or the force exerted by the tongue against the sensor”, and 14, 16, 43, 69);
comparing the recipient's tongue position to at least one predetermined threshold position( see Para 14: “causing electrical pulses to be delivered the ventral surface of the tongue via the one or more electrodes when the tongue is not in an anterior position, not in close proximity to the sensor, not touching the sensor and/or not exerting a prescribed force upon the sensor” also Para 53 and Fig. 8A-8B) at which the recipient's tongue does not substantially impair breathing of the recipient during sleep (see Para 42-43); and
in response to said comparing, selectively generating and applying stimulation signals to the recipient's tongue and/or hypoglossal nerve (see Abstract: “electrical stimulation of the hypoglossal nerve to move the tongue into an anterior position or to maintain the tongue in an anterior position”, and Para 58, 60, 65, 68) such that the recipient's tongue moves to a modified position (see Para 15: “a defensive reflex is trained wherein the tongue moves anteriorly or dorsally in response to an onset of low-amplitude electrical stimulation”, and Para 53, 65, 69) further from substantially impairing breathing of the recipient during sleep than is the recipient's tongue at the at least one predetermined threshold position (see Para: “the tongue (e.g., branches of the hypoglossal nerve) to move the tongue to an anterior position, maintain the tongue in an anterior position, and/or maintain or increased tone in the tongue extensor muscles during sleep, thereby avoiding obstruction of the upper airway”). (McCreery clearly teaches that the predetermined threshold position for the tongue is to be at an anterior position while monitoring the tongue position and stimulating the hypoglossal nerve.)
Regarding Claim 2, McCreery teaches the modified method of claim 1, wherein the method is performed to treat obstructive sleep apnea (see Para 14: “the present invention provides for a method to treat obstructive sleep apnea or to avoid an apneic or hypoxic episode in a subject”, and 16, 41, 70, 62, 72).
Regarding Claim 5, McCreery further teaches the modified method above, wherein said selectively generating and applying stimulation signals is performed only when the recipient's tongue is in a range of positions closer to substantially impairing breathing of the recipient than is the at least one predetermined threshold position (see Para 62: “moving the tongue anteriorly before it has moved sufficiently posteriorly so as to begin to obstruct the upper airway. In other embodiments, the method involves moving the tongue anteriorly even after it has moved sufficiently posteriorly to obstruct the upper airway”, also Para 43, 64, 67, 76-77).
Regarding Claim 6, McCreery further teaches the modified method above, wherein said selectively generating and applying stimulation signals is performed using a stimulation device on or implanted within the recipient's body (see Fig. 3,6 and Para 47-49: “The sensor is adapted for mounting in the subject's mouth. In one embodiment, the sensor is adapted for mounting behind the subject's teeth. Particularly useful is having the sensor adapted for mounting behind the subject's lower incisor teeth. In a specific embodiment, the sensor is mounted on a dental fixture adapted for attaching to the lingual surface of the lower teeth … a sensor 301 to detect the position of the tongue is provided. The sensor also may be mounted on a dental fixture 302 that attaches to the lingual surface of the lower teeth … the electrodes 403 that deliver electrical stimulation to the tongue extensor muscles may be mounted on the posterior part of the dental fixture 402. In another embodiment, the electrodes may be attached to flexible cylindrical carriers 404. The carriers may be composed of silicone rubber. The carriers' flexibility enables the electrodes to maintain contact with the ventrolateral surface of the tongue”).
Regarding Claim 8, McCreery teaches an apparatus comprising (see Abstract: “an apparatus, a system and a method for the treatment of obstructive sleep apnea”):
at least one stimulation device configured to generate and apply stimulation signals to a recipient's tongue and/or hypoglossal nerve (see Para 49: “the electrodes 403 that deliver electrical stimulation to the tongue extensor muscles may be mounted on the posterior part of the dental fixture 402” and Para 12-15, 50, 58, 64), the recipient's tongue responsive to the stimulation signals by moving to be further from substantially impairing respirations by the recipient (see Para 43: “conditioning and/or direct electrical stimulation of branches of the motor nerves innervating muscles that protrude the tongue (e.g., branches of the hypoglossal nerve) to move the tongue to an anterior position, maintain the tongue in an anterior position, and/or maintain or increased tone in the tongue extensor muscles during sleep”, and Para 13-15, 29, Fig, 8B);
at least one sensor configured to monitor positions of the recipient's tongue while the recipient is asleep (see Para 13: “a sensor to monitor the position of a tongue and/or the force exerted by the tongue against the sensor” and Para 14-16);
and control circuitry (see Para 13-16: “an electronic controller”, Fig. 5) configured to:
receive sensor signals from the at least one sensor, the sensor signals indicative of positions of the recipient's tongue (see Para 13-16: “a sensor to monitor the position of a tongue … an electronic controller to translate a signal received from the sensor and to deliver an electrical stimulus”, and Para 44, 57, 60); and
in response at least in part to the sensor signals, generate and transmit control signals to the at least one stimulation device (see Para 13-18: “an electronic controller to translate a signal received from the sensor and to deliver a train of electrical pulses to the one or more electrodes”, and Para 64).
Regarding Claim 9, McCreery further teaches the modified apparatus above, wherein the control circuitry is in wireless communication with the at least one sensor and/or the at least one stimulation device (see Para 44: “an electronic controller to translate the signals from the sensor into a pattern of electrical pulses that are delivered to the one or more electrodes. The sensor is in electronic communication with the controller, which is in electronic communication with the one or more electrodes. The electronic communication may be made via conventional wiring or via wireless signals known in the art”, and Para 56).
Regarding Claim 10, McCreery further teaches the modified apparatus above, wherein the at least one sensor is configured to be responsive to a position of a device on or within the recipient's tongue (see Para 14-16: “a signal received from the sensor and to deliver a train of electrical pulses to the one or more electrodes, … sensing the position of the tongue and/or the force exerted by the tongue against the sensor”, and Para 44-47, 64-67, 71).
Regarding Claim 14, McCreery further teaches the modified apparatus above, wherein the at least one sensor is configured to be disposed in the recipient's body and configured to detect physical contact with the recipient's tongue (see Fig. 4, 6-8B, Para 53: “an apparatus 801 as described herein in a subject's mouth wherein the tongue has moved 804 to an anterior position and is touching the sensor (not depicted) on the apparatus 804 and thus will not obstruct the airway 803”), electrical impedance changes due to movement of the recipient's tongue, and/or acoustic resonance changes within the recipient's mouth due to movement of the recipient's tongue (see Para 65, 68, and Fig. 5A-6).
Regarding Claim 15, McCreery further teaches the modified apparatus above, wherein the at least one sensor comprises at least one electrode in or on the recipient's tongue, and/or a front of the recipient's mouth, and/or the roof of the recipient's mouth, and/or back of the recipient's throat (see Para 47-48: “sensor is adapted for mounting in the subject's mouth …”, also Para 51-53).
Regarding Claim 20, McCreery teaches an apparatus comprising (see Abstract: “an apparatus, a system and a method for the treatment of obstructive sleep apnea”):
at least one electrode configured to stimulate a portion of a recipient's body (see Para 13-14: “one or more electrodes to deliver electrical stimuli to the ventral surface of the tongue” , also Para 16, 44, 49-52, 58, 64) such that the portion, in response to being stimulated, moves from a first position to a second position (see Para 28-29: “FIG. 8A shows an apparatus of the present invention inside the mouth with the tongue in a posterior position … FIG. 8B shows … the tongue moved to an anterior position after the delivery of electrical stimulation in accordance with an embodiment of the present invention”, and Para 14-15, 42-43, and 53);
at least one sensor configured to generate sensor signals indicative of positions of the portion (see Para 13-16: “a sensor to monitor the position of a tongue … and one or more electrodes to deliver electrical stimuli … an electronic controller to translate a signal received from the sensor and to deliver an electrical stimulus comprising of a train of charge-balanced electrical pulses to the one or more electrodes”, also Para 57); and
at least one controller configured to respond to the sensor signals by generating and transmitting control signals to the at least one electrode (see Para 13-16: “an electronic controller to translate a signal received from the sensor and to deliver an electrical stimulus comprising of a train of charge-balanced electrical pulses to the one or more electrodes”, also Para 60).
Regarding Claim 22, McCreery further teaches the modified apparatus above, wherein the at least one sensor is responsive to a position of at least one device worn on the portion (see Fig 3- 5B, Para 13-16, 44-47, 53).
Regarding Claim 23, McCreery further teaches the modified apparatus above, wherein the at least one sensor is configured to be disposed in the recipient's body (see Para 47: “The sensor is adapted for mounting in the subject's mouth. In one embodiment, the sensor is adapted for mounting behind the subject's teeth. Particularly useful is having the sensor adapted for mounting behind the subject's lower incisor teeth. In a specific embodiment, the sensor is mounted on a dental fixture adapted for attaching to the lingual surface of the lower teeth”, and Para 52-53, Fig 7).
Regarding Claim 24, McCreery further teaches the modified apparatus above, wherein the at least one sensor is part of an appliance configured to be worn inside the recipient's mouth and the portion of the recipient's body comprises a portion of the recipient's tongue (see Para 47-49: “The sensor also may be mounted on a dental fixture 302 that attaches to the lingual surface of the lower teeth (see FIG. 3)”, and Para 13-14, 16, 52, Fig. 4).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over McCreery as applied to claims above, further in view of US 20170215791 A1 to Meadows et al. (hereinafter “Meadows”).
Regarding Claim 3, McCreery teaches the method as claimed above, but fails to teach in response to said monitoring, determining at least one detected position of the recipient's tongue at which the recipient is not experiencing substantially impaired breathing; and storing the at least one detected position in tangible, computer-readable memory to be retrieved and used as the at least one predetermined threshold position.
Another reference, Meadows, teaches a methods for adjusting or titrating one or more parameters for a system for stimulating the Hypoglossal nerve of a patient to prevent obstructive sleep apnea (see Para 02), further comprising setting the at least one predetermined threshold position (see Para 12: “comparing the first physiological measurement to a first predetermined target value”) by:
in response to said monitoring, determining at least one detected position of the recipient's tongue (see Para 12: “obtaining a first physiological measurement from the patient; comparing the first physiological measurement to a first predetermined target value”) at which the recipient is not experiencing substantially impaired breathing (see Para 15: “In one embodiment, the first predetermined target value is a value of a person who does not have obstructive sleep apnea …”, also Para 13-20); and
storing the at least one detected position in tangible, computer-readable memory to be retrieved and used as the at least one predetermined threshold position (see Para 45: “the titration methods described herein may allow a clinical engineer or clinician to fit the OSA system onto a patient and determine the optimal stimulation parameters … the parameter values obtained through the titration methods may be inputted, for example, into a Titration Screen of the software used by the clinical engineer or clinician to program the OSA system, … where threshold, target and maximum stimulation parameters are determined for each of the six contacts of the system (electrodes configured for controlling position of the patient's tongue). In some embodiments, the titration methods described herein may allow the clinical software to automatically adjust levels of stimulation based upon measured and analyzed physiological signals under the guidance of the clinical engineer or clinician”, and 46, 18-19, 32-35, 37-38, 42-44).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the method of McCreery in view of Meadows teaching to include adjusting or titrating one or more parameters for a system for stimulating the Hypoglossal nerve of a patient to prevent obstructive sleep apnea (see Para 02). The modification would be obvious because the hypoglossal nerve stimulation system benefit from adaptive adjustment of stimulation parameters based on measured physiological responses, establishing a patient specific target or threshold values corresponding to breathing conditions and would improve more accurate and individualized stimulation.
Regarding Claim 4, McCreery further teaches the modified method above, wherein said setting the at least one predetermined threshold position is performed automatically by a device configured to perform said monitoring, said comparing, and said generating and applying stimulation signals (see Para 16-18: “a system for treating obstructive sleep apnea, comprising: a sensor to monitor the position of a tongue and/or the force exerted by the tongue against the sensor; one or more electrodes to deliver electrical stimulus to the ventral surface of the tongue; an electronic controller to translate a signal received from the sensor and to deliver a train of electrical pulses to the one or more electrodes; and a power source to deliver electricity to the sensor, the one or more electrodes, and/or the electronic controller … an apparatus for the treatment of obstructive sleep apnea or for avoiding an apneic or hypoxic episode in a subject, comprising: means for sensing the position of a tongue and/or the force exerted by the tongue against the means for sensing; means for delivering electrical stimulus to the ventral surface of the tongue; means for translating a signal received from the sensing means and for delivering a train of electrical pulses to the means for delivering the electrical stimulus to the ventral surface of the tongue … the present invention provides a computer readable medium having computer executable components for: monitoring the position of a tongue and/or the force exerted by the tongue against a sensor; translating a signal received from the sensor; and delivering a train of electrical pulses to the ventral surface of the tongue via one or more electrodes” and Para 42-44, 57, 64, 73”).
It is clear from McCreery teaching that the at least one predetermined threshold position is performed automatically by a device (a computer readable medium having computer executable components) configured to perform said monitoring, said comparing, and said generating and applying stimulation signals.
However, Meadows also teach a methods for adjusting or titrating one or more parameters for a system for stimulating the Hypoglossal nerve of a patient to prevent obstructive sleep apnea (see Para 02), to compare a monitored parameter to a predetermined target value (see Abstract: “comparing the first and/or second physiological measurement to a first and/or second predetermined target value, adjusting a stimulation parameter for the one of the one or more electrode contacts if the first and/or second physiological measurement differs from the first and/or second predetermined target value”, also 45-46, 18-19, 32-35, 37-38, 42-44) and adjusting stimulation based on the comparison (see Para 12-15) and automatically adjust levels of stimulation based upon measured and analyzed physiological signals (see Para 45, also Para 36-38).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Meadows teaching to further modify the invention of McCreery in order to further clarify to have a device configured to perform said monitoring, said comparing, and said generating and applying stimulation signals automatically (see Para 45, Para 36-38). Incorporating such automatic operations would predictably improve treatment by reducing the need for outside intervention (like clinician or caregivers) and enables more consistent, timely, and accurate stimulation adjustment in response to the patient condition during sleep.
Claim(s) 7, 11, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over McCreery in view of US 20220118251 A1 to Buddha et al. (hereinafter “Buddha”).
Regarding Claim 7, McCreery further teaches the modified method above, wherein said selectively generating and applying stimulation signals is performed using a stimulation device outside the recipient's body (see Para 56: “The electronic controller 200 may also include an external device interface 260 permitting the user or a medical professional to enter control commands … commands changing parameters related to electrical pulses delivered by the electronic controller 200, and the like, into the electronic controller 200”).
McCreery teach that the electronic controller includes an external device interface permitting the user or a medical professional to enter control commands to change parameters related to electrical pulses, but fail to teach that generating and applying stimulation signals is performed using a stimulation device outside the recipient's body.
However, Buddha teaches a medical apparatus for a patient comprises an external system and an implantable system (see Abstract), wherein said selectively generating and applying stimulation signals is performed using a stimulation device outside the recipient's body (see Para 121: “Each external device 500 can comprise housing 510, power supply 570, a transmitter 530, a controller 550, and/or one or more antennas 540, … Each external device 500 can further comprise one or more functional elements 599a, such as a functional element comprising a sensor, electrode, energy delivery element, a magnetic-field-generating transducer, and/or any transducer, also described in detail herebelow”, also Para 186).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Buddha’s teaching to further modify the invention of McCreery in order to generate and apply stimulation signals using an external stimulation device, so that the stimulation delivery and adjustment can be done without requiring all the stimulation device to be implanted, thereby reducing invasiveness but provide stimulation effectively.
Regarding Claim 11, McCreery teach the modified apparatus as discussed above, but fails to teach specifically that the device comprises a ferromagnetic material and the sensor comprises a magnetic field sensor.
However, Buddha teaches a medical apparatus for a patient comprises an external system and an implantable system (see Abstract) where apparatus 10 is configured to treat a patient disease or disorder selected from the group consisting of … sleep apnea; obstructive sleep apnea (see Para 112), wherein the device comprises a ferromagnetic material (see Para 108: “the magnetic energy can be applied externally and focused to specific target tissue via an implant comprising a coil and/or ferromagnetic materials”) and the sensor comprises a magnetic field sensor (see Para 211: “stimulation element 260 and/or functional element 299 comprises one or more sensors” and Para 214: “one or more stimulation elements 260 comprise a transducer configured to deliver energy to tissue, such as to treat pain and/or to otherwise stimulate or affect tissue. In some embodiments, stimulation element 260 comprises a stimulation element, such as one or more transducers selected from the group consisting of: an electrode; an energy delivery element such as an electrical energy delivery element, a light energy delivery element, a laser light energy delivery element, a sound energy delivery element, a subsonic sound energy delivery element and/or an ultrasonic sound delivery element; an electromagnetic field generating element; a magnetic field generating element”, and Para 97-98, 116-121, 154, 188, 213-214, 244).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Buddha’s teaching to further modify the invention of McCreery in order to apply controlled current or voltage to a coil or other magnetic field generating element positioned proximate tissue (see Para 108), thereby enhancing the precision and effectiveness of stimulation delivery.
Regarding Claim 21, McCreery teach the modified apparatus as discussed above, but fails to teach specifically that the at least one electrode is configured to be worn externally on the recipient's body.
However, Buddha teaches a medical apparatus for a patient comprises an external system and an implantable system (see Abstract) wherein the at least one electrode is configured to be worn externally on the recipient's body (see Para 121: “Each external device 500 can further comprise one or more functional elements 599a, such as a functional element comprising a sensor, electrode, energy delivery element, a magnetic-field-generating transducer, and/or any transducer, also described in detail herebelow”, and Fig. 2 (a method for positioning an external device on the skin of a patient)).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Buddha’s teaching to further modify the invention of McCreery to have the electrode for sensing electrical activity and/or delivering electrical energy (see Para 151) with implanted device, configuring the electrode to be worn externally would also reducing invasiveness and risk associate with the implanted stimulation device and thereby improve patient comfort.
Claim(s) 12 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over McCreery further in view of US 20110152965 A1 to Mashiach et al. (hereinafter “Mashiach”).
Regarding Claim 12, McCreery teaches the modified apparatus as discussed above, but fails to teach specifically that the device comprises at least one radio-frequency identification (RFID) tag and the sensor comprises at least one RFID reader.
However, Mashiach teaches a system and method for diagnosing and predicting an OSA event by monitoring the location of the tongue muscle (see Para 08), wherein the device comprises at least one radio-frequency identification (RFID) tag and the sensor comprises at least one RFID reader (see Para 35-36: “system 100 includes an implant 110 implanted in the muscle of a patient's tongue 140, … the implant 110 includes one or more position circuits 120 that enable reader 150 to locate the distance and/or angle and/or position to the position circuits 120 and monitor their relative position. In some embodiments of the invention, position circuits 120 may be radio frequency identification tags (RFID tags) placed in implant 110”, and Para 09, 39).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Mashiach teaching to further modify the invention of McCreery in order to locate the distance and/or angle and/or position to the position circuits and monitor their relative position, also to transmit a signal capable of being received by a receiver (see Para 35), therefore would provide a reliable source to track the position and movement of the implanted device and would help improve monitoring accuracy to provide precise control of stimulation delivery.
Regarding Claim 17, McCreery teach the modified apparatus as discussed above, but fails to teach that the at least one sensor is configured to be worn outside the recipient's mouth.
However, Mashiach further teaches a system and method for diagnosing and predicting an OSA event by monitoring the location of the tongue muscle (see Para 08), wherein the at least one sensor is configured to be worn outside the recipient's mouth (see Para 35: “an external reader 150 (for a non-limiting example, an adhesive patch that is attached to the patient's check or neck). Optionally, the implant 110 includes one or more position circuits 120 that enable reader 150 to locate the distance and/or angle and/or position to the position circuits 120 and monitor their relative position”, and Para 37, 41).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Mashiach teaching to further modify the invention of McCreery in order to monitor the motion of the tongue muscle (see Para 08) with a less invasive and more comfortable setup for patient use.
Regarding Claim 18 and 19, McCreery teach the modified apparatus as discussed above, but fails to teach the at least one sensor comprises at least one ultrasound detector configured to detect sound changes and/or acoustic resonance changes within the recipient's mouth and/or nose due to movement of the recipient's tongue and an ultrasonic source configured to generate ultrasonic signals to be detected by the at least one ultrasound detector.
However, Mashiach further teaches a system and method for diagnosing and predicting an OSA event by monitoring the location of the tongue muscle (see Para 08), wherein the at least one sensor comprises at least one ultrasound detector configured to detect sound changes and/or acoustic resonance changes within the recipient's mouth and/or nose due to movement of the recipient's tongue and an ultrasonic source configured to generate ultrasonic signals to be detected by the at least one ultrasound detector (see 59-74: “multiple readers 150 are used to monitor the location of position circuits 120 … reader 150 may include additional sensors, for example … Sensors that provide ultrasound imaging of the tongue and its location”). It is known in the art that using a sensor that can provide ultrasound imaging would be able to generate and detect the sound to create the image.
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Mashiach teaching to further modify the invention of McCreery in order to have a sensor that can generate and detect the ultrasonic signal to monitor the tongue and its location (see Para 62). Using the ultrasonic signal and detector would provide more accurate real-time monitoring and movement of the tongue position, thereby improve detection of airway condition and enable more therapeutic effectiveness.
Claim(s) 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over McCreery further in view of US 20210275346 A1 to Ow (hereinafter “Ow”).
Regarding Claim 13, McCreery teach the modified apparatus as discussed above, but fails to teach the device is configured to be repeatedly attached to the recipient's tongue and detached from the recipient's tongue.
However, Ow teaches a devices and methods of treating obstructive breathing disorders in a patient (see Abstract, and 87) wherein the device is configured to be repeatedly attached to the recipient's tongue and detached from the recipient's tongue (see Para 89, 93-94, 123, 125, 138, 141-142).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Ow’s teaching to further modify the invention of McCreery to allow selective use of therapy while minimizing interference so that it does not interfere with the normal tongue functions like tasting, talking, eating, etc. In this way, an “on-demand” tongue stabilization action may be used to improve the airflow through the airway (see Para 142) and would improve patient comfort while maintaining effective treatment when needed.
Regarding Claim 16, McCreery teach the modified apparatus as discussed above, but fails to teach the at least one sensor is configured to be repeatedly inserted within the recipient's mouth and removed from the recipient's mouth.
However, McCreery teach that the sensor can be mounted on an apparatus like dental fixture (see McCreery Para 48) and Ow teaches that the device can be repeatedly inserted within the recipient's mouth and removed from the recipient's mouth (see Para 89, 93-94, 123, 125, 138, 141-142). As a result, when the device is removed from the recipient's mouth, the sensor mounted on it is also removed and vice versa.
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Ow’s teaching to further modify the invention of McCreery to be removable so that it does not interfere with the normal tongue functions also would incorporate a removable oral device for improving patient comfort and multiple use of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20200281763 A1 - A medical device system and method are disclosed for treating obstructive sleep apnea.
US 20210290961 A1 - Systems for treating obstructive sleep apnea having an implanted stimulator with an internal sensor.
US 20160114159 A1 - An oral appliance is disclosed that provides electrical stimulation to a patient's tongue.
US 20110264164 A1 - A system and method for automatically implementing a therapy for treating sleep disordered breathing.
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/I.J./Examiner, Art Unit 3792
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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