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)(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.
Claim(s) 1-9, 11-14 and 18-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Greenberg et al (2021/0290961).
Regarding claim 1, Greenberg et al disclose a stimulation system, comprising:
an implantable stimulator configured to (a) delivery electrical stimulation to a nerve of a subject (stimulator is implantable – claims 1 and 9), and
an implantable controller, configured to control the implantable stimulator (a controller coupled to the internal sensor and the stimulation system – claim 1);
an external electronic device, configured to wirelessly communicate with the implantable controller to set or control one or more parameters of the delivery of the electrical stimulation (the remote control 130 may communicate with the stimulator 110 to control aspects of the operation of the stimulator 110 based on user input received at the remote control 130 – [0049]; fig.4; the clinician programmer 140 may be configured to receive user input and to transmit the user input to the stimulator 110 via the communications system 108 – [0049]; fig.4);
one or more implantable sensors, each configured to detect a signal indicative of a level of at least one biometric parameter of the subject, and to transmit the signal to the external electronic device (an internal sensor configured to generate a first signal corresponding to movement of the thoracic or abdominal cavity of the patient during respiration – claim 1);
one or more external sensors, each configured to detect a signal indicative of a level of at least one other biometric parameter of the subject, and to transmit the signal to the external electronic device (at least one external sensor – claim 2).
Regarding claim 2, Greenberg et al disclose wherein the external electronic device comprises: a) a wearable device, optionally a watch, a ring, a bracelet, a band, a necklace or an earring or c) a portable device, optionally comprising an external housing configured to be held or carried by the subject ([0028]. Examiner notes the limitations including “optionally…” do not provide any further patentable weight.).
Regarding claim 3, Greenberg et al disclose wherein the implantable stimulator comprises: a) an implantable pulse generator (IPG) configured to stimulate a hypoglossal nerve (stimulation system configured to deliver electrical stimulation to a nerve which innervates an upper airway muscle, such as the hypoglossal nerve – abstract; IPG - [0038]).
Regarding claim 4, Greenberg et al disclose wherein the external electronic device comprises a smart watch ([0027]).
Regarding claim 5, Greenberg et al disclose wherein the one or more implantable sensors comprise: an inertial measurement unit (“IMU”) ([0028]).
Regarding claim 6, Greenberg et al disclose wherein the one or more external sensors comprise: an IMU ([0014]), an ECG sensor ([0028]), an SpO2 sensor ([0014]) or a blood pressure sensor ([0014]).
Regarding claim 7, Greenberg et al disclose wherein one or more of the one or more external sensors are integrated into, affixed to, or placed on, a watch, a ring or an article of clothing (the external sensor 120 (e.g., as a ring, watch…in a harness - [0028]).
Regarding claim 8, Greenberg et al disclose wherein the external electronic device is further configured to receive: b) input received from a remote server, comprising one or more parameters for the delivery of the electrical stimulation ([0049]).
Regarding claim 9, Greenberg et al disclose wherein the external electronic device is configured to set or control one or more parameters of the delivery of the electrical stimulation to the nerve of the subject by setting or adjusting one or more parameters of the electrical stimulation ([0049]), wherein the parameters comprise a pulse frequency, width and/or amplitude of the electrical stimulation ([0041]).
Regarding claim 11, Greenberg et al disclose wherein the external electronic device is further configured to: determine or more biometric parameters of the subject, based on the signal received from at least one implantable sensor and/or the signal received from at least one external sensor; and activate, terminate, titrate, or adjust the delivery of the electrical stimulated by the implantable stimulator, based on the determined one or more biometric parameters ([0043]).
Regarding claim 12, Greenberg et al disclose wherein the external electronic device is further configured to: determine one or more biometric parameters of the subject, based on the signal received from at least one implantable sensor and/or the signal received from at least one external sensor; determine that the subject is experiencing, or is likely to experience, a medical condition or even, based on the determined one or more biometric parameters of the subject; and to activate, terminate, titrate, or adjust, the delivery of the electrical stimulation by the implantable stimulator in response to determining that the subject is experiencing, or likely to experience, a medical condition or event ([0052]).
Regarding claim 13, Greenberg et al disclose wherein the medical condition or even is an apnea event (abstract).
Regarding claim 14, Greenberg et al disclose wherein the implantable stimulator comprises a housing and wherein the one or more implantable sensors include one or more sensors integrated into, affixed to, or placed on the housing (a stimulator 110 comprising a sensor 102 – fig.4); and wherein the implantable stimulator is configured to turn off one or more of the one or more sensors integrated into, affixed to, or placed on the housing in response to (a) a command transmitted by the external electronic device or (b) determining that a wireless communication link has been established with the external electronic device (remote control 130 may be configured to receive a user input selecting an on/off state for the system 100 – [0049]).
Regarding claim 18, Greenberg et al disclose wherein the external electronic device comprises: a) a wearable device, optionally a watch, a ring, a bracelet, a band, a necklace or an earring or c) a portable device, optionally comprising an external housing configured to be held or carried by the subject ([0028]. Examiner notes the limitations including “optionally…” do not provide any further patentable weight.).
Regarding claim 19, Greenberg et al disclose wherein the implantable stimulator comprises: a) an implantable pulse generator (IPG) configured to stimulate a hypoglossal nerve (stimulation system configured to deliver electrical stimulation to a nerve which innervates an upper airway muscle, such as the hypoglossal nerve – abstract; IPG - [0038]).
Regarding claim 20, Greenberg et al disclose wherein the one or more implantable sensors comprise: an inertial measurement unit (“IMU”) ([0028]); and/or
the one or more external sensors comprise: an IMU ([0014]), an ECG sensor ([0028]), an SpO2 sensor ([0014]) or a blood pressure sensor ([0014]).
Regarding claim 21, Greenberg et al disclose wherein the one or more stimulation parameters received from the external electronic device cause the implantable controller to: a) begin, terminate, or titrate the delivery of the electrical stimulation ([0043]) or b) set or adjust a pulse frequency, width and/or amplitude of the electrical stimulation ([0041]).
Regarding claim 22, Greenberg et al disclose wherein the external electronic device comprises a smart watch ([0027]).
Regarding claims 23 and 24, Greenberg et al disclose wherein at least one external sensor of the one or more external sensors is integrated into, affixed to, or placed on the external electronic device (the system 100 may include one or more external device, which may each comprise at least one external sensor 120 – [0027]; fig.4).
Regarding claim 25, Greenberg et al disclose a method of treating a subject using a stimulation system, comprising a stimulator, a controller, and one or more sensors, each implantable in the subject, an external device and one or more external sensors (fig.4), comprising:
delivering, via the stimulator, (a) electrical stimulation to a nerve of a subject (stimulator is implantable – claims 1 and 9), and
controlling the stimulator via the controller (a controller coupled to the internal sensor and the stimulation system – claim 1);
wirelessly communicating with the controller, via the external electronic device, to set or control one or more parameters of delivery of the electrical stimulation (wireless links – [0039]; apply stimulation therapy based on the wireless link – [0047]; the remote control 130 may communicate with the stimulator 110 to control aspects of the operation of the stimulator 110 based on user input received at the remote control 130 – [0049]; fig.4; the clinician programmer 140 may be configured to receive user input and to transmit the user input to the stimulator 110 via the communications system 108 – [0049]; fig.4);
detecting, via the one or more implantable sensors, a signal indicative of a level of at least one biometric parameter of the subject, and to transmit the signal to the external electronic device (an internal sensor configured to generate a first signal corresponding to movement of the thoracic or abdominal cavity of the patient during respiration – claim 1); and
detecting, via the one or more external sensors, a signal indicative of a level of at least one other biometric parameter of the subject, and to transmit the signal to the external electronic device (at least one external sensor – claim 2).
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.
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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg et al (2021/0290961) in view of Kramer et al (2007/0150014).
Regarding claim 10, Greenberg et al disclose wherein the external electronic device is configured to set or control one or more parameters (the remote control 130 may communicate with the stimulator 110 to control aspects of the operation of the stimulator 110 based on user input received at the remote control 130 – [0049]; fig.4; the clinician programmer 140 may be configured to receive user input and to transmit the user input to the stimulator 110 via the communications system 108 – [0049]; fig.4), but fail to explicitly disclose wherein the one or more parameters of the delivery of an active agent to one or more cells, tissues, or organs of the subject by setting or adjusting one or more parameters, wherein the one or more parameters comprises activation of a pump, deactivation of the pump, a pumping duration, a pumping rate, a volume of active agent to deliver by the pump, and/or a timing schedule for pumping.
However, Kramer et al teach in the same medica field of endeavor, one or more parameters of delivery of an active agent to one or more cells, tissues, or organs of a subject by setting or adjusting one or more parameters, wherein the one or more parameters comprise a timing schedule for pumping (drug delivery device or a drug delivery controller – [0036]; steps 1000-1030 are performed according to a predetermined schedule, such as on a periodic basis – [0063]; fig.10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the setting or control of one or more parameters of Greenberg et al with delivering an active agent and providing a timing schedule for pumping of Kramer et al as it would provide a dual stimulation system as is well-known and conventional in the art.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg et al (2021/0290961) in view of Esteller et al (2023/0248977).
Regarding claim 15, Greenberg et al disclose the invention substantially as claimed, but fail to explicitly disclose wherein the system is configured to allow recalibration of the one or more implantable sensors using sensor data obtained from the one or more external sensors.
However, Esteller et al teach in the same medical field of endeavor, a system is configured to allow recalibration of one or more implantable sensors using sensor data obtained from one or more external sensors (calibration of an implantable neurostimulation device comprising sensing one or more sensors external to the neurostimulation device – [0006]; claim 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the stimulation system comprising one or more implantable sensors of Greenberg et al with allowing for recalibration using sensor data obtained from one or more external sensors of Esteller et al as it would provide optimizing stimulation parameters for the patient.
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 2 September 2026 have been fully considered but they are not persuasive.
Applicant states the Office Action has not identified the claimed arrangement of a separate external electronic device configured to communicate with the implantable controller to set or control one or more parameters of the delivery of the electrical stimulation or active agent by the implantable stimulator.
Examiner’s position is Greenberg et al disclose the remote control 130 may communicate with the stimulator 110 to control aspects of the operation of the stimulator 110 based on user input received at the remote control 130 – [0049]; fig.4; the clinician programmer 140 may be configured to receive user input and to transmit the user input to the stimulator 110 via the communications system 108 – [0049]; fig.4. As seen in figure 4, both the remote control 130 and clinician programmer 140 are external to the skin 117 of the patient and communicate with the controller 104 via the communications system 108 which are both implanted in the patient to provide stimulation parameters using a wireless link 116.
Greenberg et al additionally discloses an external device that is wirelessly coupled to the controller 104 and optionally to one or more of the sensors 120 ([0048]). The wireless link 116 is configured to send information both to and from the remote control 130 as seen in figure 4.
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 ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. The examiner can normally be reached Mon - Fri 6:30-2:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571)272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797
