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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 18, 2026 has been entered.
Response to Amendment
The amendment filed August 18, 2026 has been entered. Claims 1-2, 6-7, 13, 15-17 and 20 have been amended. Currently, claims 1-20 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed August 18, 2026, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gesotti (US 6,704,603) and Prochazka (US 2010/0016929; previously cited).
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8, 13-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 10-11, 20 of copending Application No. 19/270,963 in view of John (US 2008/0061961).
Claims 1, 3, 5-7, 13-15, 17 recite all of the limitations of copending claims 1 and 11 except for a system that uses both an open loop system and a closed loop system to tailor nerve stimulation, wherein the closed loop system provides automatic self-calibration of the one or more stimulation parameters, wherein the closed loop system comprises application of one or more machine learning algorithms, and wherein the open loop system allows the user to manually modify the one or more stimulation parameters. John teaches a system that uses both an open loop system and a closed loop system to tailor nerve stimulation to a user’s tremor ([0107]), 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). 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 copending claims 1 and 11 to incorporate the open loop system and closed loop system as taught by John in order to better indicate whether the nerve stimulation is benefiting the treatment through feedback detected by the sensors or to adjust the therapy if a detected tremor size has increased above a certain level for a specified duration ([0107])
Claims 2, 16 correspond to copending claims 10, 20.
Claim 4 corresponds to copending claim 6.
Claim 8 corresponds to copending claims 10, 20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: : “data portal device” in claim 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 7-8, 13-17, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over of Gesotti (US 6,704,603) in view of Prochazka (US 2010/0016929) and Burdick et al. (US 2014/0180361).
Regarding claims 1 and 13, Gesotti discloses a system that uses both an open loop and a closed loop system to tailor nerve stimulation to a user’s tremor (“a control unit adapted to aid in the relief of symptoms of Parkinson's disease” col. 2, lines 39-40), the system comprising: one or more sensors 1042-1 and 1042-2 configured to obtain data comprising one or more tremor characteristics of the user (“first and a second acceleration sensor (accelerometers) 1042-1 and 1042-2” col. 9, lines 29-54); a plurality of effectors 1044-1 and 1044-2 that are configured to be positioned on a skin surface of a wrist of the user (“wristband 1000” col. 9, lines 29-54; fig. 10) to non-invasively apply nerve stimulation transcutaneously so as to reduce the user’s tremor; and one or more controllers or processors 120 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 (“Control unit 120 selectively adjusts stimulation voltage, frequency, pulse width, waveform shape, amplitude, modulation type and the like of each electrical stimulation signal based on sensor information.” col. 4, lines 10-14) and (ii) receive one or more user inputs 123 (fig. 1) to modify the one or more stimulation parameters of the nerve stimulation according to the open loop system (“Control panel 133 and integrated control panel 123 provide an operator interface for modification of operation of adaptive stimulator 100.” col. 4, lines 26-29), wherein the closed loop system provides automatic self-calibration of the one or more stimulation parameters (“Modulation type allows selection of one of a collection of dynamic waveform changes that vary amplitude, frequency or pulse width in some predetermined manner.” col. 4, lines 10-17), wherein the open loop system allows the user to manually modify the one or more stimulation parameters (col. 4, lines 21-42); wherein the plurality of effectors comprises at least one effector for contact with the user at a first skin surface of the wrist and at least one effector for contact with the user at a second skin surface of the wrist (“Wristband 1000 includes first and second stimulation electrodes 1044-1 and 1044-2 located on the left and right sides of the wrist.” col. 9, lines 32-34).
Gesotti does not expressly disclose the nerve stimulation is applied to the median nerve of the user and a second nerve of the user; wherein the nerve stimulation has a frequency between 10 Hz and 5000 Hz, and wherein the frequency of the nerve stimulation does not exceed 5000 Hz; wherein the at least one effector for contact with the user at the first skin surface of the wrist is to stimulate the median nerve and the at least one effector for contact with the user at the second skin surface of the wrist is to stimulate the second nerve. Prochazka teaches a device for treating movement disorders such as tremors where activation of neural impulses is required to restore normal functioning ([0094]). Activation stimulation of 1 to 100 Hz ([0097]) is provided to electrodes 20, 30 that electrical stimulate the median nerve 46 and the radial nerve 50 (fig. 4) to innervate these nerves to restore normal functioning ([0100-0101]). These electrodes 20, 30 are in contact with the user at first and second skin surfaces to stimulate the median and radial nerves. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti and try using a nerve stimulation frequency between 10 Hz and 5000 Hz, wherein the frequency of the nerve stimulation does not exceed 5000 Hz, to stimulate the median nerve and the radial nerve, wherein at least one effector for contacting with the user at the first skin surface of the wrist is to stimulate the median nerve and the at least one effector for contact with the user at the second skin surface of the wrist is to stimulate the radial nerve as taught by Prochazka as the prior art teaches it is a known frequency sufficient to reduce the tremor of a user via activation of neural impulses in the median and radial nerves, the results of such a modification being reasonably predictable. Additionally, it is noted that the limitation of specifically delivering stimulation to the median nerve and the second nerve is an intended use and does not further limit the structure of the device. “[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).
Gesotti 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 Gesotti 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 2, Gesotti discloses wherein the plurality of effectors 1044-1 and 1044-2 are on a wearable device 1000 comprising a band that is configured to wrap partially or completely around the wrist of the user (“wristband 1000” col. 9, lines 29-54; fig. 10), and Gesotti in view of Prochazka disclose wherein the second nerve comprises at least one of a radial nerve or an ulnar nerve ([0100-0101]; fig. 4).
Regarding claims 3, 14, Gesotti 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 a 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 7, Gesotti discloses wherein the system comprises a wearable device 1000 that comprises a band that is configured to wrap partially or completely around the rest of the user (“wristband 1000” col. 9, lines 29-54; fig. 10), and wherein the wearable device comprises the one or more sensors 1042-1 and 1042-2 and the plurality of effectors 1044-1 and 1044-2 (fig. 10).
Regarding claims 8, 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).
Regarding claim 15, Gesotti 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 a 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]; “remote computing device 157” [0101]) and further discloses at least a second one of the one or more processors is on a data portal device (“computing device 152 may be implemented as a cellular telephone, tablet computing device” [0101]).
Regarding claim 16, Gesotti discloses wherein the plurality of effectors 1044-1 and 1044-2 comprise a plurality of electrodes on a wearable device 1000 (“wristband 1000” col. 9, lines 29-54; fig. 10), and wherein the plurality of electrodes comprises at least one electrode for contact with the user at a first skin surface of the wrist and at least one electrode for contact with the user at a second skin surface of the wrist (“Wristband 1000 includes first and second stimulation electrodes 1044-1 and 1044-2 located on the left and right sides of the wrist.” col. 9, lines 32-34), and Gesotti in view of Prochazka disclose wherein the at least one electrode for contact with the user at the first skin surface of the wrist is to stimulate the median nerve and the at least one electrode for contact with the user at a second skin surface of the wrist is to stimulate at least one of a radial nerve or an ulnar nerve ([0100-0101]; fig. 4).
Regarding claim 17, Gesotti discloses wherein the system comprises a wearable device 1000 that comprises a band that is configured to wrap partially or completely around the rest of the user (“wristband 1000” col. 9, lines 29-54; fig. 10).
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over of Gesotti (US 6,704,603) 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 4, Gesotti discloses a wearable device 1000 (fig. 10) comprising the plurality of effectors 1044-1 and 1044-2 with first and second electrical leads 1046-1 and 1046-2 for coupling the plurality of effectors to the one or more controllers or processors 120 (col. 9, lines 29-54). Therefore Gesotti does not expressly disclose at least a first one of the one or more controllers or processors is on a wearable device that comprises the plurality of effectors. Wu et al. teaches wherein at least one of one or more controllers or processors 114 (fig. 1) is on a wearable device (fig. 2) that comprises the one or more effectors comprising a plurality of electrodes E1-E4 (fig. 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti to position the first one of the one or more controllers or processors on the wearable device that comprises the plurality of effectors/electrodes as taught by Wu et al. as such a configuration is known in the art to obtain predictable results, and would not alter the overall operation of the device.
Regarding claim 5, Gesotti discloses wherein the plurality of effectors 1044-1 and 1044-2 comprise a plurality of electrodes (col. 9, lines 29-54).
Regarding claim 6, Gesotti discloses wherein the plurality of electrodes are spaced apart on a band 1000 that is configured to wrap partially or completely around the wrist of the user (“wristband 1000” col. 9, lines 29-54; fig. 10).
Claim(s) 9-11, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over of Gesotti (US 6,704,603) in view of Prochazka (US 2010/0016929) and Burdick et al. (US 2014/0180361) and further in view of John (US 2008/0061961).
Regarding claims 9 and 18, Gesotti does not expressly disclose wherein the one or more tremor characteristics comprise at least one of an amplitude or a frequency of the user’s tremor. John teaches a system to tailor nerve stimulation to a user’s tremor ([0107]) the system comprising one or more sensors configured to obtain data comprising one or more tremor characteristics of the user such as the amplitude or frequency of the user’s tremor (“tremor magnitude” [0116]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the sensors of Gesotti to determine amplitude or frequency tremor characteristics as taught by John as it is a known measurement of a tremor, the results of such a modification being reasonably predictable.
Regarding claim 10, Gesotti does not expressly disclose wherein adjustment 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. John teaches 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]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti to provide a comparison between the received tremor characteristics from the one or more sensors and desired tremor characteristics as taught by John in order to determine if the stimulation is improving the user’s tremor.
Regarding claim 11, Gesotti in view of John disclose 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).
Claim(s) 12, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gesotti (US 6,704,603) 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, Gesotti 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 Gesotti 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
