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 .
Response to Amendment
Applicant’s amendment dated May 6, 2026 is acknowledged. Currently claims 1-26 are pending in this application, with claims 15-26 withdrawn from consideration.
Response to Arguments
Applicant’s arguments regarding the term “gross movement” have been considered and are persuasive. Examiner notes that the broadest reasonable interpretation of the term that is used for examination is any movement that is capable of being detected by an inertial measurement unit.
Applicant's arguments regarding the rejections under Dieken have been fully considered but they are not persuasive inasmuch as they apply to the amended rejections required by the amendments to the claims.
Examiner notes that the amendments to the claims have required new rejections under 35 U.S.C. 112.
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.
Claim 1 recites the phrase “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, independent of a respiratory signal.” The phrase “independent of a respiratory signal” is unclear, as it is not clear how the respiratory signal is obtained or how it is “independent” of the gross movement. It is suggested to first positively recite obtaining the respiratory signal and determination between the gross movement and the respiratory sensor.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Dieken (WO 2020/102193, as cited by Applicant) in view of Chan (US 2022/0386944).
Regarding claim 1, as best the claim can be understeood, 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]).
As best the claim can be understood, Diekens does not expressly disclose detecting gross movement independent of a respiratory signal. Chan discloses that it is known in the art of sleep stage determination to separate out gross movement from respiratory signals (e.g. [0031], wherein gross movement is filtered from other signals). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the filtering of respiratory signals from gross movement signals in order to provide the system with the predictable results of a reliable means of stimulating based on actual patient movement and not constant respiratory signal.
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
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792
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