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 .
Response to Amendment
The preliminary amendment filed June 5, 2025 has been entered. Claim 1 has been canceled. Claims 2-21 are new and pending for examination.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 2-7, 11-12 and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 10-11, 13, 15-16, 18 of U.S. Patent No. 10,625,074. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader in scope than the patented claims.
Claims 2-8, 11-13 and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 7, 8, 12-14 of U.S. Patent No. 9,452,287. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader in scope than the patented claims.
Claim 2 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 and 18 of copending Application No. 19/271,267 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader in scope than the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 2, 14-15 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 11 of copending Application No. 19/402,604 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader in scope than the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 2, 14-15 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 11-14 and 16 of copending Application No. 19/402,128 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader in scope than the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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) 2-4, 6-13, 15-17, 19, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prochazka (US 2010/0016929) in view of John (US 2008/0061961).
Regarding claim 2, Prochazka discloses a system for treating tremor, the system comprising: a decision unit (“stimulator” [0090]); and a first peripheral nerve effector 20 configured to be positioned to modulate a peripheral nerve of a user (“median nerve 46” [0098]; fig. 2); wherein the decision unit causes the system to deliver a first stimulus to the peripheral nerve through the first peripheral nerve effector to reduce tremor in an extremity of the user ([0098]). Prochazka et al. does not expressly disclose wherein the decision unit comprises a processor and a memory for storing instructions that, when executed by the processor, cause the system to: characterize one or more features of the tremor, the one or more features of the tremor selected from the group consisting of tremor frequency, tremor period, and tremor magnitude; and set one or more parameters of the first stimulus based on the characterization of the one or more features of the tremor.
John teaches a system for treating tremor, where a stimulator decision unit (“control subsystem” [0084]) comprises a processor (“microprocessor” [0084]) and a memory (“programmable memory” [0084]) for storing instructions that, when executed by the processor, cause the system to: characterize one or more features of the tremor ([0116]), the one or more features of the tremor selected from the group consisting of tremor frequency, tremor period, and tremor magnitude (“Tremor magnitude, such as power within a frequency range that corresponds to the primary oscillations of the tremor, and the treatment criterion used by the evaluation protocol of the treatment program can dictate that if the tremor magnitude is greater than a first specified threshold that stimulation should occur” [0116]); and set one or more parameters of a first stimulus based on the characterization of the one or more features of the tremor (“a sensing subsystem 54 that communicates with at least one sensor 60 adapted to collect information from the patient, thereby allowing the timer-programmer 50 to adjust treatment, for example, based upon patient state values derived from sensed data” [0063]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Prochazka to include a processor and a memory for storing instructions that, when executed by the processor, cause the system to: set one or more parameters of the first stimulus based on the characterization of one or more features of the tremor that have been characterized based on one or more features selected from the group consisting of tremor frequency, tremor period, and tremor magnitude as taught by John in order to provide closed-loop adjustment of stimulation treatment that can more effectively determine when to treat specific tremors ([0086]; [0116]).
Regarding claim 3, Prochazka discloses a second peripheral nerve effector 20 in communication with the decision unit, the second peripheral nerve effector comprising at least one electrode, wherein the memory for storing instructions that, when executed by the processor, further cause the decision unit to deliver a second stimulus to a second peripheral nerve (“radial nerve 50” [0100]) in the extremity through the second peripheral nerve effector ([0100]; fig. 4).
Regarding claim 4, Prochazka in view of John disclose a measurement unit 54, wherein the instructions, when executed by the processor, further cause the decision unit to: measure a movement of the extremity of the user using the measurement unit to generate motion data (“A separate contact 15c is located peripherally, and is used to sense electromyographic (EMG) activity in a limb.” [0054]); and determine one or more of a tremor frequency, period and magnitude based on an analysis of the motion data ([0116]).
Regarding claim 6, Prochazka discloses causing the decision unit to deliver the first stimulus as a plurality of bursts of electrical stimulation ([0102], [0106]).
Regarding claim 7, Prochazka in view of John disclose causing the decision unit to set parameters of the first stimulus based on the determined tremor frequency ([0057]).
Regarding claim 8, Prochazka in view of John disclose wherein the analysis of the motion data is performed on a predetermined length of time of the motion data ([0146]).
Regarding claim 9, Prochazka discloses the peripheral nerve is selected from a median nerve, a radial nerve, and an ulnar nerve (“median nerve 46” [0098]; fig. 2).
Regarding claim 10, Prochazka discloses wherein the peripheral nerve modulated by the first peripheral nerve effector is a median nerve ([0098]; fig. 4) and wherein the second peripheral nerve is a radial or ulnar nerve (“radial nerve 50” [0100]; fig. 4).
Regarding claim 11, Prochazka discloses wherein the peripheral nerve effector 20 is adapted to deliver the first stimulus through a skin of the user (fig. 2).
Regarding claim 12, Prochazka in view of John disclose at least one sensor 15c configured to sense a movement of the user (“A separate contact 15c is located peripherally, and is used to sense electromyographic (EMG) activity in a limb.” [0054]).
Regarding claim 13, Prochazka discloses wherein the decision unit is configured to wirelessly communicate with the first peripheral nerve effector ([0137]).
Regarding claim 15, Prochazka discloses a system for treating tremor, the system comprising: a decision unit (“stimulator” [0090]); and a first peripheral nerve effector 20 configured to be positioned to modulate a peripheral nerve of a user (“median nerve 46” [0098]; fig. 2); wherein the decision unit causes the system to deliver a first stimulus to the peripheral nerve through the first peripheral nerve effector to reduce tremor in an extremity of the user ([0098]). Prochazka et al. does not expressly disclose at least one sensor configured to measure movement of an extremity of the user to characterize one or more features of the tremor, the one or more features of the tremor selected from the group consisting of tremor frequency, tremor period, and tremor magnitude; wherein the decision unit comprises a processor and a memory for storing instructions that, when executed by the processor, cause the system to: set one or more parameters of the first stimulus based on the characterization of the one or more features of the tremor.
John teaches a system for treating tremor, where at least one sensor 15c is configured to measure movement of an extremity of the user to characterize one or more features of the tremor (“A separate contact 15c is located peripherally, and is used to sense electromyographic (EMG) activity in a limb.” [0054]), the one or more features of the tremor selected from the group consisting of tremor frequency, tremor period, and tremor magnitude (“Tremor magnitude, such as power within a frequency range that corresponds to the primary oscillations of the tremor, and the treatment criterion used by the evaluation protocol of the treatment program can dictate that if the tremor magnitude is greater than a first specified threshold that stimulation should occur” [0116]); and a stimulator decision unit (“control subsystem” [0084]) comprises a processor (“microprocessor” [0084]) and a memory (“programmable memory” [0084]) for storing instructions that, when executed by the processor, cause the system to: set one or more parameters of a first stimulus based on the characterization of the one or more features of the tremor (“a sensing subsystem 54 that communicates with at least one sensor 60 adapted to collect information from the patient, thereby allowing the timer-programmer 50 to adjust treatment, for example, based upon patient state values derived from sensed data” [0063]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Prochazka to include a sensor configured to measure movement of an extremity of the user to characterize one or more features of the tremor, the one or more features of the tremor selected from the group consisting of tremor frequency, tremor period, and tremor magnitude; and to include a processor and a memory for storing instructions that, when executed by the processor, cause the system to: set one or more parameters of the first stimulus based on the characterization of the one or more features of the tremor as taught by John in order to provide closed-loop adjustment of stimulation treatment that can more effectively determine when to treat specific tremors ([0086]; [0116]).
Regarding claim 16, Prochazka discloses a second peripheral nerve effector 20 in communication with the decision unit, the second peripheral nerve effector comprising at least one electrode, wherein the memory for storing instructions that, when executed by the processor, further cause the decision unit to deliver a second stimulus to a second peripheral nerve (“radial nerve 50” [0100]) in the extremity through the second peripheral nerve effector ([0100]; fig. 4).
Regarding claim 17, Prochazka in view of John disclose a measurement unit 54, wherein the instructions, when executed by the processor, further cause the decision unit to: measure a movement of the extremity of the user using the measurement unit to generate motion data (“A separate contact 15c is located peripherally, and is used to sense electromyographic (EMG) activity in a limb.” [0054]); and determine one or more of a tremor frequency, period and magnitude based on an analysis of the motion data ([0116]).
Regarding claim 19, Prochazka in view of John disclose causing the decision unit to set parameters of the first stimulus based on the determined tremor frequency ([0057]).
Regarding claim 21, Prochazka discloses the peripheral nerve is selected from a median nerve, a radial nerve, and an ulnar nerve (“median nerve 46” [0098]; fig. 2).
Claim(s) 5 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prochazka (US 2010/0016929) in view of John (US 2008/0061961) and further in view of Tass et al. (US 2006/0276853).
Regarding claims 5 and 18, Prochazka does not expressly disclose the decision unit delivers a second stimulus offset in time from the first stimulus by a predetermined fraction or multiple of a period of the tremor. Tass et al. teaches desynchronizing tremor ([0011]) by forming individual stimuli with suitable time delays in order to produce desynchronization between the stimulated neuron populations to be desynchronized. These time delays determined as fractions of the period of the oscillatory neural activity to be desynchronized or a multiple of one N-th of the period ([0075]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a delay between a first stimulus and a second stimulus by a predetermined fraction or multiple of a period of a tremor as taught by Tass et al. in order to more effectively produce desynchronization of the neuron population responsible for the tremors.
Claim(s) 14 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prochazka (US 2010/0016929) in view of John (US 2008/0061961) and further in view of Werder et al. (US 2007/0255323).
Regarding claims 14 and 20, Prochazka does not expressly disclose wherein the first peripheral nerve effector is configured to provide a vibratory stimulus. Werder et al. teaches application of vibrational stimulation is known in the art to be 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 Prochazka to substitute and try a vibratory stimulus for electrical stimulation to the user as taught by Werder et al. as it is a known equivalent in the art of treating tremors, 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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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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/ERICA S LEE/Primary Examiner, Art Unit 3796
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