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
Applicant’s election without traverse of Invention I and Species with the following subspecies: 1D, 2D, 3A in the reply filed on April 20, 2026 is acknowledged. Claims 1-11 are pending under examination. Claims 12-32 are withdrawn from consideration.
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.
Claims 1-8 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Connor et al. (US 2022/0409897).
In re claim 1, O’Connor discloses a stimulation system [0047], comprising:
a mouthpiece ([0039]: “a non-implanted power source, e.g., including one or more mouthpiece portions”; NOTE: Although the embodiments disclose a collar, O’Connor discloses it could have been a mouthpiece) comprising
one or more sensors [0104] to intraorally sense physiological data of a subject ([0140]: “associated wearable device can have an intraoral mouthpiece”; [0060]: “in response to data (e.g., received via one or more sensors”); and
a subcutaneously implantable device (fig 7A: 120, 130; [0086])
to be in communication with the mouthpiece ([0049]: “the wearable device… can be configured to transmit power (e.g., wirelessly) to one or more of the implantable devices”) and
comprising one or more stimulators to stimulate a hypoglossal nerve of the subject [0091] to treat sleep apnea [0039].
In re claim 2, O’Connor discloses
wherein the one or more sensors comprise at least one of an ultrasound sensor, a moisture sensor, a temperature sensor, an inertial sensor ([0101]: “can include one or more motion/orientation sensors (e.g., … inertial measurement units”)), an electrocardiogram sensor, a pulse oximeter, an airflow sensor, a microphone, a pressure sensor, an actigraphy sensor, or an electroencephalogram sensor.
In re claim 3, see above (In re claim 2)
In re claim 4, see above (In re claim 2) and regarding the following limitation:
the one or more sensors comprise at least two ([0098]: “receiving data from multiple sensors”)
In re claim 5, O’Connor discloses
wherein the mouthpiece comprises
a transmitter to wirelessly transmit a communication signal ([0049]: “power transmission device… can be configured to transmit power (e.g., wirelessly)”) based on the physiological data sensed by the one or more sensors ([0060]: “power transmission from the wearable device to individual ones of the implantable devices can be cycled on and off based at least partially in response to data), and
the subcutaneously implantable device comprises
a receiver to wirelessly receive the communication signal ([0054]: “housing may be flexible, and can carry a receiver antenna (or other suitable power reception device), which receives power from the wearable device via the wireless transmission link”).
In re claim 6, O’Connor discloses
wherein the mouthpiece comprises:
a battery (fig 9: 184; [0097]: “the power source can include one or more batteries”); and
a controller [0050]
to determine, based on the physiological data, that an apneic event of the subject has occurred ([0104]: last sentence; [0050]: “the wearable device and/or the programmer can receive and/or analyze these data”), and
to cause the transmitter to transmit the communication signal as a stimulation-start signal in response to determining that the apneic event has occurred ([0060]: “the power transmission can be activated in response to data indicating that the patient is experiencing an apneic event”).
In re claim 7, O’Connor discloses
wherein the mouthpiece is to transmit the communication signal as a data signal comprising at least some of the physiological data ([0093]: “configured to communicate power and/or data”), and
the subcutaneously implantable device comprises a controller [0050]
to determine, based on the physiological data ([0063]: “implantable devices receiving power can be configured to receive data associated with the patient”), that an apneic event of the subject has occurred [0060] and
to stimulate the hypoglossal nerve in response to determining that the apneic event has occurred [0091].
In re claim 8, O’Connor discloses wherein the one or more stimulators are to stimulate at least a hypoglossal nerve [0091].
In re claim 10, O’Connor discloses wherein the subcutaneously implantable device comprises a battery to provide power to the one or more stimulators ([0064]: “the implantable device can include one or more small charge storage devices (e.g., … batteries)”).
In re claim 11, O’Connor discloses wherein the subcutaneously implantable device comprises:
a receiver to wirelessly receive a communication signal from the mouthpiece [0054]; and
a controller communicatively coupled to the receiver [0104] and
to cause power to be provided from the battery to the one or more stimulators in response to the receiver receiving the communication signal ([0064]: “signal generator in that it receives power that is wirelessly transmitted to the implantable device, and generates the signal that is ultimately delivered to the patient… the implantable device can include one or more small charge storage devices (e.g., … batteries)).
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over O’Connor et al. (US 2022/0409897) in view of Bolea (US 2014/0228905).
In re claim 9, O’Connor discloses
wherein the subcutaneously implantable device comprises a housing ([0054]; fig 5A: 135) comprising one or more electronic components [0054], and
wherein the one or more stimulators comprises:
a stimulator lead extending, at a proximal end of the stimulator lead, from the housing (134: the lead extends proximally from the housing; [0054]); and
a ring-shaped electrode positioned along the stimulator lead (131; [0053]) and to stimulate the hypoglossal nerve [0077].
O’Connor lacks
a cuff electrode positioned along the stimulator lead and to stimulate the hypoglossal nerve.
Bolea teaches a system for treating obstructive sleep apnea [0002] by using a neurostimulator with a lead that has a nerve cuff electrode that is implanted subcutaneously that stimulates the hypoglossal nerve [0128].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of O’Connor with using a cuff electrode as taught by Bolea, as cuff electrodes are designed specifically to wrap around a nerve so more targeted electrical stimulation can be delivered to the desired location.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Greenberg et al. (US 2021/0290961) teaches a system for treating sleep apnea comprising an implanted stimulator and external sensors to sense physiological data (abstract). The stimulator is configured to deliver electrical stimulation to a nerve (abstract).
Radmand (US 11,191,663) teaches an oral appliance used to treat sleep apnea that can use different type of sensors to detect sleep apnea (abstract). The oral appliance is a mouthpiece that is customizable (col 5, ln 1-5).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
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, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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