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 with respect to the previous rejection(s) of the claims have been fully considered but are not found persuasive.
Applicant contends that the combination of Bolea and Toth is improper because one concerned with treating OSA would not look to Toth which is directed to stopping sympathetic nerve activity. The examiner respectfully disagrees and notes that the test for combining references is what the combination of disclosures taken as a whole would suggest to one of ordinary skill in the art. In re McLaughlin, 170 USPQ 209 (CCPA 1971). References are evaluated by what they suggest to one versed in the art, rather than by their specific disclosures. In re Bozek, 163 USPQ 545 (CCPA) 1969. In this case, both references are directed towards implantable neurostimulators which directly stimulate neural pathways. This relation, in combination with the cited sections, would be sufficient for a system based modification to be dynamically configurable to act as either a sensing or stimulating electrode. Similarly, although Gliner when compared to Bolea has different electrode configurations, dynamically configuring and selecting the sensing and stimulating electrodes does not impact or change the individual references and their electrode configurations. Accordingly, the rejections are maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 36 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 56 recites the phrase “such that…the third electrode extend along an axis of the hypoglossal nerve when the flexible carrier is wrapped around the hypoglossal nerve”. This limitation, in combination with the other limitations of the claim, fail to be supported by the disclosure as originally filed. The disclosure briefly mentions the ability of the array to wrap around a nerve; however, the examiner was unable to find any discussion of an orientation with wrapping where the electrodes extend along an axis of the hypoglossal nerve as claimed. It is required that applicant indicate where support lies for this claim language or amend the claims to fall within the scope of the disclosure as originally filed.
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 35-56 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea et al. (US 2008/0103545) in view of Toth et al. (WO 2013/181137 A1; hereinafter “Toth”), further in view of Gliner (USP# 7,305,268).
Regarding claims 35 and 45, Bolea discloses an implantable stimulator / teaches a method for stimulating muscles or nerves, the implantable stimulator comprising: an array of electrodes (e.g. ¶¶ 111); and at least one processing device configured to: select, from within the array of electrodes a plurality of sensing electrodes (e.g. ¶¶ 72) and a plurality of stimulating electrodes for electrically stimulating at least one of a nerve or muscle of a subject (e.g. ¶¶ 103); detect, based on signals received from the plurality of sensing electrodes, a measurement of an electromyography signal (e.g. ¶¶ 329, 343) and dynamically select one or more stimulating electrodes from within the plurality of stimulating electrodes to activate for stimulating the nerve or muscle, the one or more selected stimulating electrodes being selected based on the measurement in order to stimulate a desired area of the nerve or muscle (e.g. ¶¶ 329, 343); and receive, from an external device, power used both to activate the one or more selected stimulating electrodes and to stimulate the nerve or muscle (e.g. ¶¶ 55 – “powered by a long-life primary battery or rechargeable battery, or an external neurostimulator (ENS) wirelessly linked (e.g., inductive) to an implanted receiver unit connected to the leads”).
Bolea fails to expressly disclose each electrode of the array of electrodes is dynamically configurable to act as either a sensing or stimulating electrode. In the same field of endeavor, Toth discloses an array of electrodes where individual electrodes may be configured to provide sensing or stimulation as necessitated by the procedural context (e.g. ¶¶ 195). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to use the known technique of employing programmable electrodes capable of providing sensing or stimulation as taught by Toth, to improve the similar device of Bolea, in the same manner.
Bolea fails to expressly disclose dynamically configuring and selecting the sensing and stimulating electrodes after implantation of the stimulator; however, in the same field of endeavor, Gliner discloses the ability to dynamically configure and select the sensing and stimulating electrodes after implantation, in order to avoid invasive procedures to adjust the target stimulation sights for the patient (e.g. Col 9, ll 26-65). It would have been obvious to one of ordinary skill, prior to the effective filing date of the present invention, to incorporate a similar programming configuration as taught by Gliner, to dynamically adjust and configure the electrodes after implantation, to improve the device of Bolea in a similar fashion.
Regarding claims 36 and 46, Bolea discloses the power for activating the one or more selected stimulating electrodes is used for causing a muscle contraction (e.g. ¶¶ 153).
Regarding claims 39 and 49, Bolea discloses receiving stimulation signals from the external device (e.g. ¶¶ 55).
Regarding claims 41 and 51, Bolea discloses receiving a command from the external device and transmitting responses to the external device (e.g. ¶¶ 312).
Regarding claims 44 and 54, Bolea discloses the selected electrodes are activated whenever power is provided (e.g. ¶¶ 73 – “controlling the delivery of only the minimally required energy necessary for stimulation of the nerve”).
Regarding claim 55, Bolea discloses the power received from the external device is not used to activate one or more unselected electrodes within the array of electrodes (e.g. ¶¶ 73 – “controlling the delivery of only the minimally required energy necessary for stimulation of the nerve”).
Regarding claims 37 and 47, Bolea discloses the implantable stimulator is located in a vicinity of the subject's tongue and the method further comprises causing a contraction of a genioglossus muscle of the subject using the received power (e.g. ¶¶ 39-40 – “genioglossus muscle).
Regarding claims 38 and 48, Bolea discloses causing a dilation of a pharynx using the received power (e.g. ¶¶ 63).
Regarding claims 40 and 50, Bolea discloses the external device is a transmitter configured to wirelessly transmit power to the implantable stimulator (e.g. ¶¶ 47 – where the external device provides the charge, or recharge, required to power the neurostimulator
Regarding claims 42 and 52, Bolea discloses the measurement is indicative of a sleep- apnea related event (e.g. ¶¶ 41).
Regarding claims 43 and 53, Bolea discloses the measurement is indicative of a precursor to a sleep-apnea related event (e.g. ¶¶ 41).
Regarding claim 56, Bolea discloses a system, comprising: an array of electrodes disposed on a flexible carrier configured to wrap around a hypoglossal nerve of a patient, the array of electrodes including a first electrode, a second electrode, and a third electrode arranged on the flexible carrier such that the first electrode, the second electrode, and the third electrode extend along an axis of the hypoglossal nerve when the flexible carrier is wrapped around the hypoglossal nerve (e.g. ¶¶ 48, 111); an implantable stimulator electrically connected to the array of electrodes by at least one flexible wire, the implantable stimulation including: a housing, at least one sensor configured to sense a physiological parameter of a respiratory system of the patient, and a controller disposed within the housing and in signal communication with the at least one sensor (e.g. ¶¶ 45), the controller configured to: receive a communication from an external device for selecting at least one of the first electrode, the second electrode, and the third electrode that will participate in stimulating the hypoglossal nerve of the patient, receive at least one signal from the at least one sensor, the at least one signal indicative of the physiological parameter of the respiratory system of the patient that is sensed, and generate a stimulation signal for use by the array of electrodes for stimulating the hypoglossal nerve to treat obstructive sleep apnea (e.g. ¶¶ 55 – “powered by a long-life primary battery or rechargeable battery, or an external neurostimulator (ENS) wirelessly linked (e.g., inductive) to an implanted receiver unit connected to the leads”).
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