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 Arguments
Applicant’s arguments are directed towards the newly presented claim amendments which have changed the scope of the invention; however, upon further search and consideration due to the change in scope, an updated grounds of rejection is presented below, necessitated by amendment.
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 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.
(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, 3-5, and 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bolea et al. (US 2008/0103545; hereinafter “Bolea”).
Regarding claim 1, Bolea teaches a method for sensing a subject's breathing, the method comprising: generating, by a control unit, a modulation signal, the modulation signal comprising an electrical stimulation pattern (e.g. ¶¶ 48-54; e.g. ¶¶ 342 – “proportion of stimulation intensity of two electrode cuffs used to stimulate a nerve can be modulated”); applying, by the control unit, the modulation signal to at least one pair of electrodes associated with an implant unit implanted inside the subject's body (e.g. ¶¶ 59-60, 75-78, etc.); measuring, by at least one acoustic sensing unit, an acoustic signal caused by the subject's breathing during an electrical nerve stimulation session (e.g. ¶¶ 70 – “The respiratory sensor(s) may measure…acoustic airflow...indicative of respiration”), and measuring, by at least one motion sensing unit, a motion signal caused by the subject's breathing during the electrical nerve stimulation session, wherein the at least one motion sensing unit comprises at least one inertial measurement unit (e.g. ¶¶ 56 – “a patient's motion may be detected by, for example, using an internal accelerometer”); processing, by the control unit, the measured acoustic signal and the measured motion signal to detect inhalation and exhalation phases of the subject over time (e.g. ¶¶ 306 – “a microphone that is worn or is in proximity to the patients' face”; where the examiner notes that the disclosure is clear that the purpose of this measurement is for modulation of an electrical nerve stimulation session to prevent OSA); assigning, by the control unit and based on the detected inhalation and exhalation phases, a value that is indicative of a hit rate and/or of an inspiratory airflow, wherein the hit rate is a quantification of level of stimulation synchronization with the subject's inhalation phases (e.g. ¶¶ 227-251 – where the examiner considers the algorithm analysis to perform this assigning of a value indicative of an inspiratory airflow and quantifies a level of stimulation synchronization with the subject's inhalation phases); and adjusting, by the control unit, at least one parameter of the electrical stimulation pattern in response to the value indicative of the hit rate and inspiratory airflow (e.g. ¶¶ 226 – “neurostimulation system described herein may operate in a closed-loop process wherein the step of delivering stimulation 390 to the targeted nerve may be a function of a sensed feedback parameter (e.g., respiration). For example, stimulation of the hypoglossal nerve may be triggered to occur during the inspiratory phase of respiration. In a health human subject, the hypoglossal nerve is triggered about 300 mS before inspiration. Accordingly, a predictive algorithm may be used to predict the inspiratory phase and deliver stimulation accordingly. FIG. 48 schematically illustrates a system 480 including devices, data and processes for implementing a self-adjusting predictive trigger algorithm.”).
Regarding claim 3, Bolea discloses the acoustic signal comprises breathing sounds of the subject (e.g. ¶¶ 306 – “a microphone that is worn or is in proximity to the patients' face”; ¶¶ 70 – “The respiratory sensor(s) may measure…acoustic airflow...indicative of respiration”) and that the motion signal comprises a movement or contraction of one or more muscles related to the subject’s airway (e.g. ¶¶ 298 – “As the patient breathes, the patient's chest and/or abdomen expands and contracts, thus changing the cross-sectional area of the shape (i.e., hoop) formed by the wire resulting in changes in inductance”).
Regarding claim 4, Bolea discloses the acoustic sensing unit comprises at least one microphone (e.g. ¶¶ 306 – “a microphone that is worn or is in proximity to the patients' face”).
Regarding claim 5, Bolea discloses the movement or contraction of the muscles related to the subject’s airway comprises an airway muscle contraction, a change of position of the subject’s tongue and/or a change of the tongue’s spatial orientation within the subject (e.g. ¶¶ 342 – “The proximal cuff will be more likely to stimulate branches of the hypoglossal nerve going to muscles in the upper airway involved with tongue or hyoid retrusion while the more distal electrode cuff will more likely stimulate only the muscles involved with tongue/hyoid protrusion.”).
Regarding claim 8, Bolea discloses the at least one inertial measurement unit comprises at least one accelerometer (e.g. ¶¶ 56 – “internal accelerometer”).
Regarding claim 9, Bolea discloses the at least one parameter comprises a single pulse frequency (e.g. ¶¶ 340).
Regarding claim 10, Bolea discloses the implant unit configured for implantation in the vicinity of the any muscle associated with the subject's airway opening (Figs. 51 – 910/64, etc.); an external device configured for communication with the implant unit (Figs. 51 – 920/916/912, etc.); and the least one motion sensing unit (e.g. ¶¶ 289-299 – “external respiratory sensors 916/918”; e.g. ¶¶ 56, etc.).
Regarding claim 11, Bolea discloses the at least one acoustic sensing unit is part of the external device and wherein the at least one motion sensing unit is part of the external device (e.g. ¶¶ 289-299 – “external respiratory sensors 916/918” – where the examiner considers the motion sensors to be the chest motion sensor from ¶¶ 298 and the acoustic sensing unit as the microphone from ¶¶ 306 in relation to ¶¶ 70 – “The respiratory sensor(s) may measure…acoustic airflow...indicative of respiration”).
Regarding claim 12, Bolea discloses treating obstructive sleep apnea (e.g. Abstract - OSA).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
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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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
