DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments combined with the claim amendments have been fully considered and are found persuasive with respect to the previous rejection(s); 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 § 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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over by Kirby et al. (US 2010/0100150; hereinafter “Kirby”) in view of Rondoni et al. (US 2020/0230412; hereinafter “Rondoni”).
Regarding claim 12, Kirby discloses a system, comprising: a sensor configured to sense at least one physiological parameter associated with a respiratory system of a patient (e.g. ¶¶ 42 – pressure sensor in the neck); an array of electrodes supported by a flexible carrier configured to be wrapped around a hypoglossal nerve of the patient (e.g. ¶¶ 26-27 – cuff electrode array – “the cuff may have one or more monitoring contacts 7 and stimulating contacts 9”); and a controller disposed within a housing (e.g. ¶¶ 38 – where the examiner notes that at least the controller is implanted and in a hermetically enclosed sterile housing) and in communication with the sensor and the array of electrodes (e.g. ¶¶ 28), the controller configured to: receive at least one signal from the sensor and cause at least a subset of electrodes of the array of electrodes to stimulate the hypoglossal nerve of the patient at least partially in response to the at least one signal (e.g. ¶¶ 28-29).
Kirby discloses at least 2 stimulating electrodes (e.g. ¶¶ 29 – “Stimulating contact 9 of cuff 5 includes a first contact and a second contact”) and the potential of a plurality of stimulating electrodes (e.g. ¶¶ 26 – “the cuff may have one or more monitoring contacts 7 and stimulating contacts 9”); however, it is unclear whether the subset of stimulating electrodes includes at least two of a first, second, and third electrode of the array of stimulating electrodes as claimed. In the same field of endeavor, Rondoni teaches the selective stimulation of at least two stimulating electrodes of a plurality of electrodes in a cuff, in order to effectively stimulate the appropriate portion of the nerve (e.g. ¶¶ 207). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to apply the known technique of selective stimulation of a subset of at least 3 stimulating electrodes in a cuff electrodes, as taught by Rondoni, to the known device of Kirby, in order to improve the invention in a similar manner and provide more effective targeted stimulation.
Regarding claim 13, Kirby discloses the controller is configured to cause the subset of electrodes to stimulate the hypoglossal nerve of the patient according to a stimulation protocol (e.g. ¶¶ 26 – “the cuff may have one or more monitoring contacts 7 and stimulating contacts 9” – where in this embodiment the subset would be the 2 stimulating electrodes out of the 4 total electrodes – 2 monitoring and 2 stimulating).
Regarding claim 14, Kirby discloses the stimulation protocol includes at least two of a pulse width, a pule amplitude, and a pulse shape (e.g. ¶¶ 9 – “Amplitude and pulse width”).
Regarding claim 15, Kirby discloses the controller is configured to receive a selection of the subset of electrodes from an external device (e.g. ¶¶ 18 – “The controller, the monitoring contact of the cuff, the at least one stimulating contact of the cuff, or any combination thereof may be turned off when the position sensing device determines that the patient is in a position other than the lying down position”).
Regarding claim 16, Kirby discloses the flexible carrier has a length between 0.01 mm and 10 mm (e.g. Fig. 4 – where the examiner notes that the entire length of the hypoglossal nerve in the neck is 20mm and the carrier would clearly be less than 10mm or half the length).
Regarding claim 17, Kirby discloses a battery disposed within the housing, the battery configured to supply power to the controller (e.g. Fig. 1, #19, ¶¶ 38).
Regarding claim 18, Kirby discloses the array of electrodes are electrically coupled to the controller by at least one flexible wire (e.g. ¶¶ 40).
Allowable Subject Matter
Claims 20-22 are 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.
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
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