DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant's election with traverse of Group II, Claims 12-18 in the reply filed on 17 February 2026 is acknowledged. The traversal is on the ground(s) that both groups recite receipt of sensor signals. This is not found persuasive because although they receive sensing signals, group II does not require the power supply disposed within the housing as in group III, and group III does not require the specific subset of electrodes to include at least two electrodes of a first, second, and third electrode as in group II, continuing to differentiate the two groups from one another by combination / subcombination. Accordingly, the requirement is still deemed proper and is therefore made FINAL. Claims 1-11 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/group, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
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.
Claims 12-18 are rejected under 35 U.S.C. 102(b) as being anticipated by Kirby et al. (US 2010/0100150; hereinafter “Kirby”).
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), wherein the subset of electrodes includes at least two electrodes of a first electrode, a second electrode, and a third electrode of the array of electrodes (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 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).
Conclusion
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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