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 .
Claim Objections
Claim 5 is objected to because of the following informalities: The claim is missing a period at the end. Appropriate correction is required.
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.
Claims 1-20 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 13 recite, “wherein the closed loop system comprises application of one or more machine learning algorithms”. While the originally filed specification states, “a controller 2222 which can optimize the stimulation parameters using various algorithms, including machine learning algorithms” ([0204] of the published application) and details how the stimulation algorithm can optimize the stimulation, such disclosure is not an algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP 2061.01, 2163.02 and 2181, subsection IV.
Claims 2-12 and 14-20 are rejected to for being dependent on claims 1 and 13, respectively.
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.
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.
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.
Claim(s) 1, 3-5, 8-11, 13-15, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over John (US 2008/0061961) in view of Prochazka (US 2010/0016929) and Burdick et al. (US 2014/0180361).
Regarding claim 1, John discloses a system that uses both an open loop system and a closed loop system to tailor nerve stimulation to a user’s tremor ([0107]) by making real time adjustments to the nerve stimulation, the system comprising: one or more sensors configured to obtain data comprising one or more tremor characteristics of the user (“tremor magnitude” [0116]); one or more effectors 10a that are configured to apply nerve stimulation to the user ([0054]); one or more controllers or processors configured to (i) receive the data from the one or more sensors and to adjust one or more stimulation parameters of the nerve stimulation according to the closed loop system ([0063]; “responsive stimulation is stimulation which is triggered in response to sensed data when analysis of the data results in detection of one or more abnormal medical events” [0095]; [0107]) and (ii) receive one or more user inputs to modify the one or more stimulation parameters of the nerve stimulation according to the open loop system ([0102]), wherein the closed loop system provides automatic self-calibration of the one or more stimulation parameters ([0100]; 92 fig. 6a; 90 fig. 6b), wherein the open loop system allows the user to manually modify the one or more stimulation parameters (90c fig. 6a; 90 fig. 6b).
John does not expressly disclose the one or more effectors are configured to apply the nerve stimulation to at least a median nerve of the user; wherein the one or more effectors are configured to apply the nerve stimulation transcutaneously. Prochazka discloses it is known in the art to treat a user’s tremor (“The invention can be applied to treat various conditions in which stimulation to either activate or block neural impulses is required. Such conditions can include movement disorders (e.g., spasticity, hypertonus, rigidity, tremor and/or muscle weakness, Parkinson's disease, dystonia, cerebral palsy)” [0076]) with one or more transcutaneous effectors 20 (fig. 3-4) configured to apply nerve stimulation to at least a median nerve 46 of the user ([0098-0101]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify John and try applying open loop and closed loop system to a median nerve of the user via one or more transcutaneous effectors as taught by Prochazka in order to provide peripheral nerve stimulation ([0043]) that is more targeted to specific extremities (“The median nerve 46 innervates most of the flexor muscles in front of the forearm, most of the short muscles of the thumb, and the short muscles of the hand” [0098]) and can assist in restoring normal functioning ([0101]), the transcutaneous application of use of one or more effectors known in the art to obtain predictable results.
John does not expressly disclose wherein the closed loop system comprises application of one or more machine learning algorithms. Burdick et al. teaches applying a machine learning algorithm to a closed loop system where adjustments to neurostimulation are performed based on information received from sensors is known in the art ([0191-0194]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify John to apply one or more machine learning algorithms to the closed loop system as taught by Burdick et al. in order to more efficiently search for effective parameter combinations ([0196]).
Regarding claim 3, John in view of Burdick et al. disclose wherein at least a first one of the one or more controllers or processors is on a cloud computing network or server (“remote computer 49… remote computer 49 may be another computer, a server, a router, a network PC, a client, a memory storage device, a peer device or other common network node, and typically includes many or all of the elements described above relative to the computing device 12” [0215-0217]).
Regarding claims 4-5, John in view of Prochazka disclose wherein at least a second one of the one or more controllers or processors (“stimulator (not illustrated)” [0090]) is on a wearable device (fig. 4) that comprises the one or more effectors comprising a plurality of electrodes 20 (fig. 4).
Regarding claim 8, the limitation, “wherein the system is configured to provide the nerve stimulation for up to 24 hours in a day” is a matter of intended use, and does not result in a structural difference between the claimed invention and the prior art. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 9, John discloses wherein the one or more tremor characteristics comprise at least one of an amplitude or a frequency of the user’s tremor (“tremor magnitude” [0116]).
Regarding claim 10, John discloses wherein the modification of the one or more stimulation parameters in the closed loop system is based on a comparison between the one or more tremor characteristics received from the one or more sensors and desired tremor characteristics ([0107]).
Regarding claim 11, John discloses wherein, if a predetermined tremor condition is not exceeded, then the one or more stimulation parameters are not adjusted ([0107]; no alert is generated, no stimulation parameter is triggered for adjustment).
Regarding claim 13, John discloses a system that uses both an open loop system and a closed loop system to tailor nerve stimulation to a user’s tremor ([0107]) by making real time adjustments to the nerve stimulation, the system comprising: one or more sensors configured to obtain data comprising one or more tremor characteristics of the user (“tremor magnitude” [0116]); one or more effectors 10a that are configured to apply nerve stimulation to the user ([0054]); one or more controllers or processors configured to (i) receive the data from the one or more sensors and to adjust one or more stimulation parameters of the nerve stimulation according to the closed loop system ([0063]; “responsive stimulation is stimulation which is triggered in response to sensed data when analysis of the data results in detection of one or more abnormal medical events” [0095]; [0107]) and (ii) modify the one or more stimulation parameters of the nerve stimulation according to the open loop system ([0102]), wherein the closed loop system provides automatic self-calibration of the one or more stimulation parameters ([0100]; 92 fig. 6a; 90 fig. 6b), wherein the open loop system allows the user to manually modify the one or more stimulation parameters (90c fig. 6a; 90 fig. 6b).
John does not expressly disclose the one or more effectors are configured to apply the nerve stimulation to at least a median nerve of the user. Prochazka discloses it is known in the art to treat a user’s tremor (“The invention can be applied to treat various conditions in which stimulation to either activate or block neural impulses is required. Such conditions can include movement disorders (e.g., spasticity, hypertonus, rigidity, tremor and/or muscle weakness, Parkinson's disease, dystonia, cerebral palsy)” [0076]) with one or more effectors 20 (fig. 3-4) configured to apply nerve stimulation to at least a median nerve 46 of the user ([0098-0101]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify John and try applying open loop and closed loop system to a median nerve of the user via one or more effectors as taught by Prochazka in order to provide peripheral nerve stimulation ([0043]) that is more targeted to specific extremities (“The median nerve 46 innervates most of the flexor muscles in front of the forearm, most of the short muscles of the thumb, and the short muscles of the hand” [0098]) and can assist in restoring normal functioning ([0101]).
John does not expressly disclose wherein the closed loop system comprises application of one or more machine learning algorithms. Burdick et al. teaches applying a machine learning algorithm to a closed loop system where adjustments to neurostimulation are performed based on information received from sensors is known in the art ([0191-0194]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify John to apply one or more machine learning algorithms to the closed loop system as taught by Burdick et al. in order to more efficiently search for effective parameter combinations ([0196]).
Regarding claim 14, John in view of Burdick et al. disclose wherein at least a first one of the one or more controllers or processors is on a cloud computing network or server (“remote computer 49… remote computer 49 may be another computer, a server, a router, a network PC, a client, a memory storage device, a peer device or other common network node, and typically includes many or all of the elements described above relative to the computing device 12” [0215-0217]).
Regarding claim 15, John in view of Prochazka disclose wherein at least a second one of the one or more controllers or processors (“stimulator (not illustrated)” [0090]) is on a wearable device (fig. 4) that comprises the one or more effectors (fig. 4).
Regarding claim 18, John discloses wherein the one or more tremor characteristics comprise at least one of an amplitude or a frequency of the user’s tremor (“tremor magnitude” [0116]).
Regarding claim 19, the limitation, “wherein the system is configured to provide the nerve stimulation for up to 24 hours in a day” is a matter of intended use, and does not result in a structural difference between the claimed invention and the prior art. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim(s) 2, 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over John (US 2008/0061961) in view of Prochazka (US 2010/0016929) and Burdick et al. (US 2014/0180361) and further in view of Gross et al. (US 2013/0066393) and Wu et al. (US 2007/0185409).
Regarding claim 2, John in view of Burdick et al. disclose wherein at least a first one of the one or more controllers or processors is on a cloud computing network or server (“remote computer 49… remote computer 49 may be another computer, a server, a router, a network PC, a client, a memory storage device, a peer device or other common network node, and typically includes many or all of the elements described above relative to the computing device 12” [0215-0217]). John in view of Prochazka disclose wherein at least a second one of the one or more controllers or processors (“stimulator (not illustrated)” [0090]) is on a wearable device (fig. 4) that comprises the one or more effectors, wherein the one or more effectors comprise a plurality of electrodes 20, wherein the plurality of electrodes comprise at least one electrode 20 for contact with the user at a skin surface above the median nerve 46, at least one electrode 20 for contact with the user at a skin surface above a radial nerve 50 (fig. 4; [0100]).
John does not expressly disclose at least one electrode for contact with the user at a skin surface above an ulnar nerve, and wherein the wearable device comprises a band that is configured to wrap partially or completely around a wrist of the user. Gross et al. teaches it is known in the art to deliver stimulation to the ulnar nerves to treat tremor ([0124]) and Wu et al. also teaches it is known in the art to focus stimulation to the ulnar nerve ([0057]) for delivering stimulation to the hand with the use of a band (fig. 4) configured to wrap partially or completely around a wrist of the user for positioning electrodes S1-S4 at a skin surface above targeted nerves ([0028], [0057]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify John to provide at least one electrode for contact with the user at a skin surface above an ulnar nerve, and wherein the wearable device comprises a band configured to warp partially or completely around a wrist of the user as taught by Gross et al. and Wu et al. as contacting the user at a skin surface above an ulnar nerve and using a band to position the electrodes over the nerves is known in the art to obtain predictable results, and would not alter the overall operation of the device.
Regarding claim 6, John in view of Prochazka disclose wherein the plurality of electrodes comprise at least one electrode 20 for contact with the user at a skin surface above the median nerve 46, at least one electrode 20 for contact with the user at a skin surface above a radial nerve 50 (fig. 4; [0100]). John does not expressly disclose at least one electrode for contact with the user at a skin surface above an ulnar nerve. Gross et al. teaches it is known in the art to deliver stimulation to the ulnar nerves to treat tremor ([0124]) and Wu et al. also teaches it is known in the art to focus stimulation to the ulnar nerve ([0057]) for delivering stimulation to the hand with the use of a band (fig. 4) configured to wrap partially or completely around a wrist of the user for positioning electrodes S1-S4 at a skin surface above targeted nerves ([0028], [0057]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify John to provide at least one electrode for contact with the user at a skin surface above an ulnar nerve as taught by Gross et al. and Wu et al. as contacting the user at a skin surface above an ulnar nerve is known in the art to obtain predictable results, and would not alter the overall operation of the device.
Regarding claim 16, John in view of Prochazka disclose wherein the one or more effectors comprise a plurality of electrodes 20, wherein the plurality of electrodes comprise at least one electrode 20 for contact with the user at a skin surface above the median nerve 46, at least one electrode 20 for contact with the user at a skin surface above a radial nerve 50 (fig. 4; [0100]). John does not expressly disclose at least one electrode for contact with the user at a skin surface above an ulnar nerve. Gross et al. teaches it is known in the art to deliver stimulation to the ulnar nerves to treat tremor ([0124]) and Wu et al. also teaches it is known in the art to focus stimulation to the ulnar nerve ([0057]) for delivering stimulation to the hand with the use of a band (fig. 4) configured to wrap partially or completely around a wrist of the user for positioning electrodes S1-S4 at a skin surface above targeted nerves ([0028], [0057]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify John to provide at least one electrode for contact with the user at a skin surface above an ulnar nerve as taught by Gross et al. and Wu et al. as contacting the user at a skin surface above an ulnar nerve is known in the art to obtain predictable results, and would not alter the overall operation of the device.
Claim(s) 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over John (US 2008/0061961) in view of Prochazka (US 2010/0016929) and Burdick et al. (US 2014/0180361) and further in view of Wu et al. (US 2007/0185409).
Regarding claim 7, John does not expressly disclose the wearable device comprises a band that is configured to wrap partially or completely around a wrist of the user. Wu et al. teaches it is known in the art to focus stimulation to the median nerve ([0057]) with the use of a band (fig. 4) configured to wrap partially or completely around a wrist of the user for positioning electrodes S1-S4 at a skin surface above targeted nerves ([0028], [0057]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device of John to comprise a band configured to warp partially or completely around a wrist of the user as taught by Wu et al. as using a band to position the electrodes over the nerves is known in the art to obtain predictable results, and would not alter the overall operation of the device.
Regarding claim 17, John does not expressly disclose the wearable device comprises a band that is configured to wrap partially or completely around a wrist of the user. Wu et al. teaches it is known in the art to focus stimulation to the median nerve ([0057]) with the use of a band (fig. 4) configured to wrap partially or completely around a wrist of the user for positioning electrodes S1-S4 at a skin surface above targeted nerves ([0028], [0057]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device of John to comprise a band configured to warp partially or completely around a wrist of the user as taught by Wu et al. as using a band to position the electrodes over the nerves is known in the art to obtain predictable results, and would not alter the overall operation of the device.
Claim(s) 12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over John (US 2008/0061961) in view of Prochazka (US 2010/0016929) and Burdick et al. (US 2014/0180361) and further in view of Werder et al. (US 2007/0255323).
Regarding claims 12 and 20, John discloses effectors can include magnetic, optical and other types of stimulation intended to modulate biological activity ([0055]) but does not expressly disclose wherein the one or more effectors comprises at least one effector configured to provide at least one of a vibrotactile stimulation or an ultrasonic excitation. Werder et al. teaches application of vibrational stimulation is known into the art to be an equivalent to electrical stimulation of the skin for treatment of tremors (“Parkinson’s disease”) ([0009]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify John to substitute and try vibrational stimulation for electrical stimulation to the user as taught by Werder et al. as it is a known equivalent in the art and would yield predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796