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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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, 7, 11, 16 have been amended. Currently, claims 1-20 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 6-9, 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 Therefore, the rejection has been withdrawn.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).
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-6 and 13-16 of copending Application No. 19/271,273 in view of Gesotti (US 6,704,603) and Prochazka (US 2010/0016929).
Claims 1-2, 8-10 and 11-12, 19-20 of the instant application recite all of the same limitations as claims 3 and 13 of the copending application except for the waveform generator to generate a waveform and the one or more stimulation parameters comprise a frequency between 10 Hz and up to 5000 Hz. Gesotti describes it is known in the art for a generator 126 to generate waveforms for providing to a plurality of spaced-apart stimulation electrodes (col. 4, lines 44-64). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a waveform generator to provide stimulation waveforms to stimulation electrodes as it is known in the art and yield predictable results. Prochazka teaches delivering electrical stimulation to nerves of a user at a frequency between 10 Hz up to 5000 Hz is known in the art (“1 and 100 Hz” [0077]) to reduce Parkinson’s disease tremor ([0115]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try using an electrical stimulation frequency greater between 10 Hz up to 5000 Hz as taught by Prochazka as the prior art teaches it is a known frequency sufficient to reduce the tremor of a user, the results of such a modification being reasonably predictable.
Claim 3 recites the one or more sensors comprise one or more motion sensors. This is recited in copending application claims 4 and 14.
Claim 4 recites the one or more sensors comprise a multi-axis accelerometer or gyroscope. A multi-axis accelerometer or gyroscope are known sensors in the art for detecting motion and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a multi-axis accelerometer or gyroscope as the one or more sensors.
Claims 5 and 18 require the stimulation parameters further comprise an amplitude. Gesotti teaches amplitude is a common parameter for stimulation (col. 4, lines 11-19). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the stimulation parameters to further comprise an amplitude as it is known in the art and would yield predictable results.
Claims 6 and 13-15 recite the wearable device comprises the processor and the one or more sensors. This configuration is known in the art as shown in copending application claims 5 and 15.
Claims 7 and 16 recite the wearable device is configured to wirelessly communicate with the data portal device configured to receive the data, the data portal device further configured to transmit the data to the cloud-based computing network or the server for processing of the data. This transferring of data between communicating data porta devices and cloud-based servers is known in the art as shown in copending application claims 6 and 16.
Claim 17 recites the one or more movements of the wrist of the user comprise at last one tremor characteristic of the user. Motion sensing is recited in copending application claims 4 and 14.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 5, 10-11, 18 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-19 of copending Application No. 19/271,267 in view of Gesotti (US 6,704,603).
Claims 1 and 11 of the instant application recite all of the same limitations as claim 17 of the copending application except for the waveform generator to generate a waveform. Gesotti describes it is known in the art for a generator 126 to generate waveforms for providing to a plurality of spaced-apart stimulation electrodes (col. 4, lines 44-64). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a waveform generator to provide stimulation waveforms to stimulation electrodes as it is known in the art and yield predictable results.
Claims 5 and 18 recite the one or more stimulation parameters further comprises an amplitude. This is recited in copending application claim 18.
Claims 10 and 20 recite limitations found in copending application claim 19.
This is a provisional nonstatutory double patenting rejection.
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: “computing device” in claims 11 and 14 which according to the specification is selected from the group consisting of a smartphone, tablet and laptop ([0073] of the published application); and “data portal device” in claims 1, 11 and 16. Claims 7-8 and 19 are not interpreted under 35 U.S.C. 112(f) because these claims define the data portal device “is a smartphone or tablet computer”, therefore providing structure. The term “wearable device” as recited in independent claims 1, 11 and subsequent dependent claims is not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because even though the claim limitation(s) uses a generic placeholder that is coupled with functional language, claims 1 and 11 define the wearable device “comprises a band”, therefore providing structure..
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) 1-5, 9-13, 15, 17-20 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).
Regarding claim 1, Gesotti discloses a non-invasive system for reducing tremor (col. 2, lines 13-16), comprising: a plurality of spaced-apart stimulation electrodes 1044-1 and 1044-2, wherein the plurality of spaced-apart stimulation electrodes are positioned on a wearable device 1000 so as to provide non-invasive transcutaneous electrical stimulation so as to reduce a user’s tremor (fig. 10; col. 9, lines 29-54), wherein the plurality of spaced-apart stimulation electrodes comprises at least one electrode for contact with the user at a first skin surface of a wrist of the user and at least one electrode for contact with the user at a second skin surface of the wrist of the user (“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), wherein the wearable device comprises a band 1000, and wherein the band is configured to wrap partially or completely around the wrist of the user (fig. 10); a waveform generator 126; a processor 122 configured to cause the waveform generator to generate a waveform that is provided to one or more of the plurality of spaced-apart stimulation electrodes, wherein the waveform comprises one or more stimulation parameters (col. 4, lines 53-64); and one or more sensors 1042-1 and 1042-2 configured to obtain data corresponding to one or more movements of the wrist of the user (“a first and a second acceleration sensor (accelerometers) 1042-1 and 1042-2” col. 9, lines 35-36), wherein the one or more movements of the wrist of the user comprise tremor characteristics (col. 2, lines 13-16), wherein the processor 122 is configured to adjust the one or more stimulation parameters to reduce the user’s tremor based on processing of the data using an algorithm (col. 4, lines 35-43).
Gesotti does not expressly disclose the electrical stimulation is to at least a median nerve of a user and a second nerve of the user to reduce a user’s tremor; the at least one electrode for contact with the user at a first skin surface of a wrist of the user to stimulate the median nerve and the at least one electrode for contact with the user at a second skin surface of the wrist of the user to stimulate the second nerve; wherein the one or more stimulation parameters comprise a frequency between 10 Hz and up to 5000 Hz. Prochazka teaches a device for treating movement disorders such as tremors where activation of neural impulses is required to restore normal function ([0094]). Activation stimulation of 1 to 100 Hz ([0097]) is provided to electrodes 20, 30 that electrically stimulate the median nerve 46 and the radial nerve 50 (fig. 4) to innervate these nerves to restore normal functioning ([0100-0101]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti and try using an electrical stimulation frequency between 10 Hz and up to 5000 Hz to stimulate the median nerve and 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 discloses wherein the processor 122 includes software that includes algorithms for processing information from input signals (E.N. regarded as obtained data corresponding to movements of the wrist of the user from sensors 1042-1 and 1042-2) and determines the response(s) required to produce stimulation (col. 4, lines 35-43) but does not expressly disclose the algorithms are one or more machine learning algorithms. Nor does Gesotti disclose wherein the processing of the data using the one or more machine learning algorithms is configured to be performed, at least in part, on a cloud-based network, the wearable device, a data portal device, or a server. Burdick et al. teaches it is known in the art in the deliver of neural stimulation to use one or more sensors configured to obtain data and applying a machine learning algorithm where adjustments to neurostimulation are performed based on information received from the sensors ([0191-0194]). Burdick et al. also teaches it is known in the art to provide a data portal device 152 and a server 157 within a system that gathers and analyzes data ([0100-0102]) for determining stimulation parameters of a neurostimulation system ([0025]) using the machine learning algorithms ([0027]). 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 process the data on a data portal device, or a server as taught by Burdick et al. in order to more efficiently search for effective parameter combinations ([0196]) and since performing such processing on a data portal or server is known in the art, the results of such a modification being reasonably predictable.
Regarding claims 2 and 12, Gesotti in view of Burdick et al. discloses the one or more machine learning algorithms comprise a learning algorithm configured to tailor the one or more stimulation parameters over time to adjust the user’s tremor ([0191-0194]).
Regarding claim 3, Gesotti discloses wherein the one or more sensors comprise one or more motion sensors (“a first and a second acceleration sensor (accelerometers) 1042-1 and 1042-2” col. 9, lines 35-36).
Regarding claim 4, Gesotti discloses wherein the one or more sensors comprise an accelerometer (col. 9, lines 35-36) but does not expressly disclose wherein the one or more sensors comprise a multi-axis accelerometer or gyroscope. Burdick et al. however teaches motion sensors are known in the art to comprise accelerometers or gyroscopes ([0028]). 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 use a gyroscope as the one or more motion sensors as taught by Burdick et al. as it is a known type of sensor device for detecting physiological data such as motion detection on a patient, the results of such a modification being reasonably predictable in the art.
Regarding claims 5 and 18, Gesotti discloses wherein the one or more stimulation parameters further comprises an amplitude (col. 4, lines 11-14).
Regarding claim 9, Gesotti discloses the processing of the data is configured to be performed, at least in part, by the processor (col. 4, lines 35-43).
Regarding claims 10 and 20, Gesotti discloses wherein the adjustment of the one or more stimulation parameters to reduce the user’s tremor comprises real-time or periodic adjustment based on the data (col. 4, lines 21-34). Gesotti in view of Prochazka disclose wherein the second nerve comprises at least one of a radial nerve 50 or an ulnar nerve (fig. 4). The limitation, “wherein the system is configured to provide transcutaneous electrical 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 claims 11 and 17, Gesotti discloses a non-invasive system for reducing tremor (col. 2, lines 13-16), comprising: a plurality of non-invasive electrodes 1044-1 and 1044-2, wherein the plurality of non-invasive electrodes are positioned on a wearable device 1000 so as to provide non-invasive transcutaneous electrical stimulation so as to reduce a user’s tremor (fig. 10; col. 9, lines 29-54), wherein the plurality of non-invasive electrodes comprises at least one electrode for contact with the user at a first skin surface of a wrist of the user and at least one electrode for contact with the user at a second skin surface of the wrist of the user (“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), wherein the wearable device comprises a band 1000, and wherein the band is configured to wrap partially or completely around the wrist of the user (fig. 10); one or more sensors 1042-1 and 1042-2 configured to obtain data corresponding to one or more movements of the wrist of the user (“a first and a second acceleration sensor (accelerometers) 1042-1 and 1042-2” col. 9, lines 35-36); a generator 126 configured to provide electrical stimulation to at least one of the plurality of non-invasive electrodes (col. 4, lines 53-55), wherein the electrical stimulation comprises one or more stimulation parameters (col. 4, lines 53-64); a computing device 122, wherein the computing device is configured to set or adjust the one or more stimulation parameters to reduce the user’s tremor based on processing of the data corresponding to the one or more movements of the wrist of the user that is received from the one or more sensors (col. 4, lines 35-43; E.N. input signals is regarded as corresponding to movements of the wrist of the user from sensors 1042-1 and 1042-2), wherein the processor 122 is configured to adjust the one or more stimulation parameters to reduce the user’s tremor based on processing of the data using an algorithm (col. 4, lines 35-43).
Gesotti does not expressly disclose the electrical stimulation is to at least a median nerve of a user and a second nerve of the user to reduce a user’s tremor; the at least one electrode for contact with the user at a first skin surface of a wrist of the user to stimulate the median nerve and the at least one electrode for contact with the user at a second skin surface of the wrist of the user to stimulate the second nerve; wherein the one or more stimulation parameters comprises a frequency between 10 Hz and up to 5000 Hz. Prochazka teaches a device for treating movement disorders such as tremors where activation of neural impulses is required to restore normal function ([0094]). Activation stimulation of 1 to 100 Hz ([0097]) is provided to electrodes 20, 30 that electrically stimulate the median nerve 46 and the radial nerve 50 (fig. 4) to innervate these nerves to restore normal functioning ([0100-0101]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti and try using an electrical stimulation frequency between 10 Hz and up to 5000 Hz to stimulate the median nerve and 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 discloses wherein the processor 122 includes software that includes algorithms for processing information from input signals (E.N. regarded as obtained data corresponding to movements of the wrist of the user from sensors 1042-1 and 1042-2) and determines the response(s) required to produce stimulation (col. 4, lines 35-43) but does not expressly disclose the algorithms are one or more machine learning algorithms. Nor does Gesotti disclose wherein the processing of the data using the one or more machine learning algorithms is configured to be performed, at least in part, on a cloud-based network, the wearable device, a data portal device, or a server. Burdick et al. teaches it is known in the art in the deliver of neural stimulation to use one or more sensors configured to obtain data and applying a machine learning algorithm where adjustments to neurostimulation are performed based on information received from the sensors ([0191-0194]). Burdick et al. also teaches it is known in the art to provide a data portal device 152 and a server 157 within a system that gathers and analyzes data ([0100-0102]) for determining stimulation parameters of a neurostimulation system ([0025]) using the machine learning algorithms ([0027]). 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 process the data on a data portal device, or a server as taught by Burdick et al. in order to more efficiently search for effective parameter combinations ([0196]) and since performing such processing on a data portal or server is known in the art, the results of such a modification being reasonably predictable.
Regarding claim 13, Gesotti discloses wherein the wearable device 1000 comprises the one or more sensors 1042-1 and 1042-2 (fig. 10).
Regarding claim 15, Gesotti discloses wherein the plurality of non-invasive electrode 1044-1 and 1044-2 and the one or more sensors 1042-1 and 1042-2 are positioned on the band (fig. 10).
Regarding claim 19, Gesotti in view of Burdick et al. discloses wherein the data portal device 152 is configured to perform analysis of the data ([0101-0102]), and wherein the data portal device is a smartphone or tablet computer (“tablet computing device” [0101], [0215], “other means of and communications devices for establishing a communications link between the computers may be used” [0217]).
Claim(s) 6-8, 14, 16 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 Wu et al. (US 2007/0185409).
Regarding claim 6, Gesotti discloses wherein the wearable device comprises the one or more sensors 1042-1 and 1042-2 (fig. 10). Gesotti discloses electrical leads 1046-1 and 1046-2 for coupling the wearable device 1000 to a processor 122 and therefore does not expressly disclose the wearable device comprises the processor. 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 and since rearrangement of parts is a matter of obvious design choice. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
Regarding claims 7, 16, Gesotti does not expressly disclose the wearable device is configured to wirelessly communicate with a data portal device configured to receive the data, the data portal device further configured to transmit the data to a cloud-based network or a server for processing of the data, and wherein the data portal device is a smartphone or tablet computer. Burdick et al. teaches it is known in the art for a wearable device 150 to wirelessly communicate with a data portal device 152 (“The external control unit 150 may connected via a connection 154 (e.g., a USB connection, wireless connection, and the like) to an external computing device 152” [0099]), the data portal device further configured to transmit the data to a cloud-based network or server 157 ([0100]) for processing the data, and wherein the data portal device is a smartphone or tablet computer (“tablet computing device” [0101], [0215], “other means of and communications devices for establishing a communications link between the computers may be used” [0217]). 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 include a data portal device for communicating data between the wearable device and the cloud-based network or server as taught by Burdick et al. in order to provide a communications device capable of acting as an intermediary linking the wearable device to the could-based server for more effective transferring of data, the data portal device in the form of a smartphone or tablet as it is a known type of device useful for transmitting data between two devices, the results of such a modification being predictable in the art.
Regarding claim 8, Gesotti in view of Burdick et al. discloses wherein the data portal device 152 is configured to perform analysis of the data ([0101-0102]).
Regarding claim 14, Gesotti discloses wherein the wearable device 1000 comprises the one or more sensors 1042-1 and 1042-2 (fig. 10) and wherein the processing of the data is performed, at least in part, by the computing device 122 (col. 4, lines 35-43) but does not expressly disclose wherein the wearable device comprises the generator and the computing device, as electrical leads 1046-1 and 1046-2 couple the wearable device 1000 to a device 120 containg the generator 126 and the computing device 122. Wu et al. teaches it is known in the art for a device 220 comprising a processor and stimulus module can be coupled directly to wearable device (fig. 2-3). 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 computing device and generator on the wearable device 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 and since rearrangement of parts is a matter of obvious design choice. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
Conclusion
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/ERICA S LEE/Primary Examiner, Art Unit 3796
