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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. {See MPEP 609.05(b)} Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6-13, 16-17, 19, 25-31, 39-47 and 65-69 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 20090281594 A1) in view of Chavan et al. (US 20070093875 A1).
As to claim 1, King et al. discloses an implantable closed-loop neuromodulation device (Abstract; [0048]) comprising: one or more electrodes ([0034-0038]) extending from a body; a non-transitory memory ([0067]) that stores one or more template detection signals and one or more template pulses ([0120, 0127]); and a computational circuit (processor, depicted as 44 in Figure 2A; [0062]) electrically connected to the one or more electrodes (Figure 2A; [0062]), configured to: receive a detection signal based on a detected electrophysiological signal ([0096, 0098]), compare the detection signal to the one or more template detection signals ([0100, 0120]), retrieve a template pulse from the one or more template pulses stored in the non-transitory memory based on a comparison of the detection signal to the one or more template detection signals ([0101, 0120]), generate a stimulation signal based on the retrieved template pulse ([0103]), and operate the one or more electrodes to emit an electrical pulse to the nerve based on the stimulation signal ([0064, 0106, 0125]).
King et al. additionally discloses an implantable device (Figure 2A) where a “power source 48 may take the form of a small, rechargeable or non-rechargeable battery, or an inductive power interface that transcutaneously receives inductively coupled energy. In the case of a rechargeable battery, power source 48 similarly may include an inductive power interface for transcutaneous transfer of recharge power” ([0070]). King et al. discloses the invention substantially as claimed with a rechargeable battery that is recharged through power transmission, but does not explicitly disclose that the power transmission is through conversion of ultrasound energy. Chavan et al. discloses “An embodiment of the device comprises a rechargeable power supply adapted to be recharged through an ultrasound signal”(Abstract; [0007-0008, 0055]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the recharging process of King et al. to incorporate an ultrasonic transducer configured to receive ultrasonic waves and convert energy from the ultrasonic waves into an electrical energy as disclosed by Chavan et al. in order to provide the predictable results of enabling the remote charging of the implantable device (Chavan et al., [0055]).
As to claim 6, the modified King et al. discloses the one or more electrodes comprises three or more electrodes (King et al., Figure 2A).
As to claim 7, the modified King et al. discloses the device is configured to detect the electrophysiological signal from a targeted subset of nerve fibers within the nerve (King et al, [0047]).
As to claim 8, the modified King et al. discloses the device is configured to detect the electrophysiological signal from one or more targeted fascicles within the nerve, one or more targeted afferent nerve fibers within the nerve, or one or more targeted efferent nerve fibers within the nerve (King et al., [0047]).
As to claim 9, the modified King et al. discloses the device is configured to detect the electrophysiological signal from two or more different targeted fascicles within the nerve (King et al., [0044-0047]).
As to claim 10, the modified King et al. discloses the device is configured to emit the electrical pulse to a targeted subset of nerve fibers within the nerve (King et al., [0039, 0041, 0056]).
As to claim 11, the modified King et al. discloses the device is configured to emit the electrical pulse to one or more targeted fascicles within the nerve, one or more targeted afferent nerve fibers within the nerve, or one or more targeted efferent nerve fibers within the nerve (King et al., [0041, 0056]).
As to claim 12, the modified King et al. discloses the device is configured to emit the electrical pulse to two or more different targeted fascicles within the nerve (King et al., [0056, 0063]).
As to claim 13, the modified King et al. discloses the device is configured to detect the electrophysiological signal from a first targeted subset of nerve fibers within the nerve (King et al, [0044, 0047]), and to emit the electrical pulse to a second targeted subset of nerve fibers within the nerve (King et al., [0041]), wherein the first targeted subset of nerve fibers and the second targeted subset of nerve fibers are the same or different (King et al., [0041, 0044, 0047]).
As to claim 16, the modified King et al. discloses the non-transitory memory is configured to store data comprising data based on the detected electrophysiological signal, data based on the emitted electrical pulse, or data based on a detected or measured physiological condition (King et al., [0120, 0127]).
As to claim 17, the modified King et al. discloses the non-transitory memory is configured to store data received from an interrogator (sensing module, depicted as 20 in Figure 1 of King et al.; King et al., [0068-0069, 0092]).
As to claim 19, the modified King et al. discloses the data comprises a time stamp, a velocity, a direction, an amplitude, a frequency, or a waveform of the detected electrophysiological signal or the emitted electrical pulse (King et al., [0085, 0094, 0120]).
As to claim 25, the modified King et al. discloses the device further comprises a sensor configured to detect or measure a physiological condition (King et al., [0053-0054, 0068, 0072]).
As to claim 26, the modified King et al. discloses the physiological condition is temperature, pressure, heart rate or strain (King et al., [0010, 0045, 0053-0054]).
As to claim 27, the modified King et al. discloses the detection signal comprises a detected electrophysiological pulse component and an additional detected physiological condition component (King et al., [0053-0054, 0068, 0113]).
As to claim 28, the modified King et al. discloses the device comprises a first curved member comprising a first set of one or more electrodes (King et al., [0042], cuff electrodes) and a second curved member comprising a second set of one or more electrodes (King et al., [0042], cuff electrodes), wherein the first curved member and the second curved member are each configured to at least partially circumscribe the nerve at different positions along the length of the nerve (King et al., [0042]).
As to claim 29, the modified King et al. discloses the first set of one or more electrodes comprises a plurality of electrodes positioned along the first curved member (King et al., [0042, 0064]), the second set of one or more electrodes comprises a plurality of electrodes positioned along the second curved member, or both (King et al., [0042, 0064]).
As to claim 30, the modified King et al. discloses the first set of one or more electrodes comprises a curved electrode that at least partially circumscribes the nerve (King et al., [0042], cuff electrodes), the second set of one or more electrodes comprises a curved electrode that at least partially circumscribes the nerve (King et al., [0042], cuff electrodes), or both (King et al., [0042, 0064]).
As to claim 31, the modified King et al. discloses the first set of one or more electrodes and the second set of one or more electrodes are configured to detect the electrophysiological signal transmitted by the nerve (King et al., [0052-0053], sense electrodes).
As to claim 39, the modified King et al. discloses the computational circuit (processor, depicted as 44 in Figure 2A; [0062]) is configured to determine a direction or a velocity of the electrophysiological signal (King et al., [0048, 0068-0069, 0092]).
As to claim 40, the modified King et al. discloses one or more electrodes are configured to be positioned outside of the nerve and in electrical communication with the nerve (King et al., [0007, 0043]).
As to claim 41, King et al. discloses stimulation of a peripheral nerve (Abstract) by electrodes ([0034]). Therefore, the modified King et al. thus has “one or more electrodes are configured to be in contact with the epineurium of the nerve”.
As to claim 42, King et al. discloses stimulation of a peripheral nerve (Abstract) by electrodes ([0034]). Therefore, the modified King et al. thus has one or more electrodes are configured to anchor to, or “penetrate the epineurium of the nerve”.
As to claim 43, the modified King et al. discloses the computational circuit (processor) receives a detection signal (Figures 5-11, 15A-15B and 17), but does not explicitly disclose the processor is “configured to downsample the detection signal or a component of the detection signal”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the data collection by the computation circuit (processor) to include the ability to downsample data is a common data processing technique. Furthermore such a modification would provide the predictable results of optimizing data processing.
As to claim 44, the modified King et al. discloses the computational circuit (processor, depicted as 44 in Figure 2A; [0062]) is configured to generate the stimulation signal based on a direction, a velocity, a frequency, an amplitude, or a waveform of a compound action potential or a subset of the compound action potential transmitted by the nerve or a subset of nerve fibers within the nerve (King et al., [0048, 0068-0069, 0092]).
As to claim 45, the modified King et al. discloses the stimulation signal comprises a timing, amplitude, frequency, or waveform of the electrical pulse emitted by the device (King et al., [0056, 0074, 0079-0080]).
As to claims 46-47, King et al. discloses an external charger for recharging the recharable battery ([0087]). Thus the modified King et al. discloses an external charger (interrogator), which is an external device, for emitting ultrasonic waves that power the device (Chavan et al., [0007-0008, 0055]).
As to claim 65, the modified King et al. discloses one or more curved members extending from the body, the curved members configured to at least partially circumscribe a nerve (King et al., [0042], cuff electrodes), wherein the curved members comprise one or more electrodes (King et al., [0042], cuff electrodes).
As to claim 66, the modified King et al. discloses the one or more curved members comprises a plurality of electrodes positioned along the curved member (King et al., [0042, 0064]).
As to claim 67, the modified King et al. discloses the one or more curved members comprises a curved electrode that at least partially circumscribes the nerve (King et al., [0042]).
As to claim 68, the modified King et al. discloses at least one of the one or more curved members comprises two or more curved electrodes that each at least partially circumscribes the nerve on the same curved member (King et al., [0042, 0064]).
As to claim 69, the modified King et al. discloses one or more curved members extending from a body, each curved member comprising a plurality of electrodes configured to be radially positioned around an axis parallel to the length of a nerve (King et al., [0042]; since the cuff electrodes encircle the nerve, they are “radially positioned around an axis parallel to the length of a nerve”).
Claims 18 and 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over the modified King et al. as applied to claims 1, 6-13, 16-17, 19, 25-31, 39-47 and 65-69 above, in further view of Muller et al. (US 20170031441 A1).
As to claims 18 and 48, the modified King et al. discloses the device substantially as claimed with an ultrasonic transducer is configured to emit ultrasonic waves and an interrogator configured to receive the waves, but does not explicitly disclose the ultrasonic waves are “ultrasonic backscatter waves”. Muller et al. discloses the transmission of “backscattered signals” and “backscattering to transmit data”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the ultrasonic waves of the modified King et al. to include backscattered wave signals as disclosed by Muller et al. in order to provide the predictable results of employing ultrasonic backscatter waves in order to provide the predictable results of optimizing signal and data transmission.
As to claim 49, the modified King et al. discloses the interrogator is further configured to decode the data. (Muller et al., [0038]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E 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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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796