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
Claims 15-26 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group 2, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 17, 2025. Currently claims 1-26 are pending in this application with claims 15-26 withdrawn from consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “gross movement” in claim 1 is a relative term which renders the claim indefinite. The term “gross” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Since the specification does not clearly define what movements constitute “gross” movements, it is unclear what movements are covered by the claims.
The term “heaving” in claims 12-14 is a relative term which renders the claim indefinite. The term “heaving” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Since the specification does not clearly define what movements constitute a “heaving” movement, it is unclear what movements are covered by the claims.
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.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dieken (WO 2020/102193, as cited by Applicant).
Regarding claim 1, Dieken discloses a system for treating a respiratory disorder, comprising (e.g. figures 30A-J, 32-38C):
an inertial measurement unit (IMU) comprising an accelerometer, wherein the IMU is configured to detect movement by a human subject, and to generate data based on the detected movement (e.g. accelerometer based sensor 1790; figures 32-33, paragraphs [0194] -[0199]); and
a stimulator comprising (e.g. pulse generator 1510):
a stimulation system configured to deliver stimulation to a nerve which innervates an upper airway muscle (e.g. Abstract); and
a controller coupled to the stimulation system and to the IMU (e.g. controller as discussed in [0176]);
wherein the controller is configured to detect gross movement by the human subject based on the data generated by the IMU, and to cause the stimulation system to stimulate the nerve in response to the detection of the gross movement (e.g. posture detector 1840 and activity function 1842 that detects physical activity which is a “gross movement”; [0209] – [0220]).
Regarding claim 2, Dieken additionally discloses wherein the controller is further configured to detect the gross movement based on at least one predetermined threshold (e.g. threshold comparison for the activity sensor as disclosed in [0215]).
Regarding claim 3, Dieken additionally discloses wherein the at least one predetermined threshold comprises a magnitude of one or more accelerations (e.g. accelerometer-based sensor threshold of 1.15G as disclosed in [0215]).
Regarding claim 4, Dieken additionally discloses wherein the controller is further configured to detect the gross movement based on at least one predetermined threshold, and the at least one predetermined threshold comprises a magnitude of one or more translational accelerations by the human subject exceeding 0.1, 0.2, 0.3, 0.4, or 0.5 m/s2 (e.g. detection of gravitational forces of 1.15G which exceeds the above threshold; as disclosed in [0215]).
Regarding claim 5, Dieken additionally discloses wherein the controller is further configured to cause the stimulation system to stimulate the nerve after a predetermined amount of time following the detection of the gross movement (e.g. stimulation of the nerve after the expiration of a time as disclosed in [0085]).
Regarding claim 6, Dieken additionally discloses wherein the controller is further configured to cause the stimulation system to stimulate the nerve for a predetermined amount of time (e.g. stimulation for a period of time as disclosed in [0079]).
Regarding claim 7, Dieken additionally discloses wherein the stimulation system is configured to deliver stimulation to a hypoglossal nerve (e.g. stimulation of the hypoglossal nerve as shown in Figures 30A-30J).
Regarding claim 8, Dieken additionally discloses wherein the IMU is further configured to detect chest and/or abdominal movement by the subject (e.g. sensor located on thorax/abdomen region 1786 as disclosed in [0194]); and the controller is further configured to detect a respiratory signal of the human subject based on the detected chest and/or abdominal movement; and to cause the stimulation system to cease stimulating the nerve or to refrain from stimulating the nerve, when the respiratory signal indicates that human subject is not experiencing an apnea or hypopnea event (e.g. only applying stimulation when the subject is not experiencing a respiratory event as disclosed in [0201]-[0208]).
Regarding claim 9, Dieken additionally discloses a heart rate sensor (e.g. accelerometer that can acoustically detect heart rate as disclosed in [0230]); and the controller is further configured to detect a heart rate of the human subject (e.g. as taught in [0230]), and to take the human subject's heart rate into account when selecting a start or endpoint time, an intensity level, and/or a duration parameter for stimulation of the nerve (e.g. using heart rate to determine therapy as disclosed in [0230]-[0240]).
Regarding claim 10, Dieken additionally discloses wherein the system is further configured to receive input from the human subject allowing a clinician or the human subject to control one or more parameters of the stimulation system (e.g. user of computer interface 3040 to allow for the patient and doctor to at least partially control the device as disclosed in [0289]).
Regarding claim 11, Dieken additionally discloses wherein the controller is further configured to allow the clinician or the human subject to place the controller in a standby mode in which the controller ceases to detect gross movement by the human subject and/or cause stimulation of the nerve (e.g. user of computer interface 3040 to allow for the patient and doctor to at least partially control the device as disclosed in [0289] which will necessarily allow the clinician to place the device into standby mode).
Regarding claim 12, as best the claim can be understood, Dieken additionally discloses wherein the gross movement comprises a heaving motion of a chest and/or abdomen of the human subject (e.g. motions as sensed by the sensor located on thorax / abdomen region 1786 as disclosed in [0194]) and the controller is further configured to detect the heaving motion based on a velocity, and/or an acceleration, and/or a direction, and/or a frequency of the heaving motion calculated based on the data generated by the IMU (e.g. sensing as taught in [0194]).
Regarding claim 13, as best the claim can be understood, Dieken additionally discloses wherein the gross movement comprises a heaving motion, and the controller is further configured to detect the heaving motion based on a magnitude, direction, and/or frequency of the heaving motion calculated using the data generated by the IMU (e.g. motions as sensed by the sensor located on thorax / abdomen region 1786 as disclosed in [0194]).
Regarding claim 14, as best the claim can be understood, Dieken additionally discloses wherein the controller is further configured to cause stimulation of the nerve based on a frequency of the heaving motions (e.g. motions as sensed by the sensor located on thorax / abdomen region 1786 as disclosed in [0194]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bolea (2014/0228905) and Bolea et al. (2008/0103545) both disclose treating obstructive sleep apnea and sensing body movement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792