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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-19 in the reply filed on 4/23/26 is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/23/26.
Specification
The disclosure is objected to because of the following informalities: The first paragraph of the specification should be corrected for any issued patent numbers.
Appropriate correction is required.
Claim Objections
Claims 1-19 are objected to because of the following informalities: 1) In Claims 1 and 11, the “a/the plurality sets of ” should be “a/the plurality of sets of”, 2) In Claims 1 and 11, “is in communication” should be “are in communication”, 3) In Claims 1 and 11, “sets of EMS devices is configured” should be “sets of EMS devices are configured” 4) In Claims 1 and 11, “the one…stimulation programs include a plurality of …stimulation programs” should be corrected for consistency regarding the number of programs, 5) In Claims 1 and 11, line 7, “the at least one EMS device” should be “the at least one EMS device of the plurality of sets of EMS devices”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
1) In Claim 1 and 11, last clause, the “based on respective user information” is unclear. What does the “respective” refer to? Respective to what? If the respective was meant to refer back to the “a respective end user” of line 4, it should be “information from/of the respective end user”.
2) In Claim 11, “the communication channel” lacks clear antecedence.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, and 8-10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2016/0096027 by Asseo.
Regarding Claim 1, Asseo teaches a system for muscle stimulation (e.g. abstract: TENS system), the system comprising:
a computing device associated with a controlling user (e.g. ¶¶ 17, 21-22, Fig. 5: server 504, which can also be a desktop, laptop, tablet etc.); and
a plurality sets of electrical muscle stimulation (EMS) devices, wherein each set of the plurality sets of EMS devices is associated with a respective end user and a respective location, and wherein the plurality sets of EMS devices is in communication with the computing device and each of which includes an EMS device (e.g. ¶ 37, Fig. 5: TENS modules 516A-516C with electrodes 518A-518C),
wherein each EMS device of the EMS device includes:
a central body (e.g. abstract, ¶¶ 2, 5, 17-18: each TENS module/unit is a self-sufficient device that is capable of storing stimulation programs in a memory, processing the programs with a microcontroller, generating current stimulation according to the programs and providing the stimulation via the electrodes; Claim 1: a wireless TENS unit comprising an enclosure, and a microcontroller to execute one or more treatment plans) comprising:
a processing unit configured to execute a stimulation program (e.g. ¶¶ 25, 31, 39, Fig. 3: processing unit 314 stores and executes one or more treatment plans that “can be infinitely variable”; It is noted here that the claim does not require that any stimulation program is actually stored in the EMS device or anywhere else, it merely requires that processing unit of the EMS device would be able to execute the program); and
a pulse generator operatively coupled to the processing unit, wherein the pulse generator is configured to generate electrical pulses in response to the stimulation program (e.g. ¶31, Fig. 3: pulse generator 302/306/308/310); and
a pad in communication with the central body, wherein the pad is configured to be attached to the respective end user and transmit the electrical pulses to stimulate the respective end user in accordance with the stimulation program (e.g. ¶¶ 2, 19: the electrodes include pads),
wherein the plurality sets of EMS devices is configured to receive and implement the stimulation program, wherein the stimulation program includes a plurality of predetermined stimulation programs and a tailored stimulation program which is based on respective user information and different from the plurality of predetermined stimulation programs (Again, it is noted here that the claim does not require that any stimulation program is actually stored in the EMS device or anywhere else, it merely requires that processing unit of the EMS device would be capable to execute the program(s). As such, so long as the processing unit would be capable of executing the claimed program(s), it meets the respective limitations; Asseo discloses that their TENS units are an improvement over the prior art which stored and applied “only” a limited or fixed number of pre-defined setting, see ¶¶ 6, 18, by also downloading, storing, displaying, making selectable and executing infinitely variable treatment plans from the server, including plans “customized to a particular user to obtain the maximum pain relief” and can be customized based on “history of a patient’s utilization of a TENS module and associated mode of operation”, and/or based on bio-information sensors, wherein the stored, fixed and tailored programs, being further customizable by the user, see e.g. ¶¶ 18-19, 23, 27-28, 33, and as such meet the claim).
Regarding Claim 8, Asseo teaches the system of claim 1, wherein the computing device is configured to plan, manage, and track the stimulation program for each set of the plurality sets of EMS devices via a central server (e.g. ¶¶ 19,21-22,24-25,33,36-37: the plans can be customized via a server).
Regarding Claim 9, Asseo teaches the system of claim 1, wherein the one or more stimulation programs in each EMS device differ in a pulse width (e.g. ¶ 19: pulse width is varied in the treatment plans).
Regarding Claim 10, Asseo teaches the system of claim 1, wherein the one or more stimulation programs in each EMS device comprises a recovery program (e.g. ¶¶ 2-3, 19: plans are for back pain management).
Claim Rejections - 35 USC § 103
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.
Claims 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Asseo, as applied to Claim 1, in view of US 20140148871 by Southwell.
Regarding Claim 2, Asseo teaches the system of claim 1, yet does not explicitly disclose wherein the computing device is configured to authenticate whether the controlling user satisfies an authentication requirement, wherein the authentication requirement identifies an authorized healthcare professional or an authorized service provider.
However, Asseo teaches user authentication (e.g. ¶ 37), and Southwell teaches an analogous TENS system, which requires accreditation for the clinician to access software to reconfigure the TENS treatment (e.g. abstract, ¶ 111).
Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate the requirement for authentication on the clinician side (ie. the computer device) of a system according to the teachings of Asseo, as taught by Southwell, in order to predictably prevent unauthorized access to the computer device, and thus prevent unauthorized access to personal medical information and user settings.
Regarding Claim 3, Asseo as modified in Claim 2 teaches the system of claim 2, wherein the computing device comprises a mobile device configured to communicate with each set of the plurality sets of EMS devices in implementing the stimulation programs (e.g. ¶22: tablet, phablet, smart phone).
Regarding Claim 4, Asseo as modified in Claim 2 teaches the system of claim 3, wherein the computing device is configured to communicate with each set of the plurality sets of EMS devices independent from each other (e.g. ¶¶ 36-37, Fig. 5: the plans are communicated through the internet, wherein each user is authorized for their personal access).
Regarding Claim 5, Asseo as modified in Claim 2 teaches the system of claim 4, wherein the computing device is configured to provide a first stimulation program to and collect data from a first set of EMS devices among the plurality sets of EMS devices located at a first location (e.g. ¶ 28: real-time feedback from bio-sensors).
Regarding Claims 6, Asseo as modified in Claim 2 teaches the system of claim 5, wherein the computing device is, after communication with the first set of EMS devices, configured to provide a second stimulation program to and collect data from a second set of EMS devices among the plurality sets of EMS devices located at a second location which is different from the first location (e.g. ¶ 28: real-time feedback from bio-sensors; ¶64, Fig. 5: multiple TENS units/sets 516A-516C at multiple locations).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Asseo/Southwell, as applied to Claim 6, and further in view of US 20120059436 by Fontaine.
Regarding Claim 7, Asseo as modified in Claim 2 teaches the system of claim 6, yet does not explicitly disclose wherein the first set of EMS devices and the second set of EMS devices are configured to communicate with each other.
Asseo does not explicitly disclose that each set comprises a second central body substantially similar to the first central body, wherein the second central body is configured to receive a broadcast command over the communication channel and generate second electrical pulses in response thereto.
However, Fontaine teaches an analogous EMS stimulation system which comprises multiple pod units to apply stimulation to different body parts at the same time (e.g. ¶¶ 1,64-65,87,107, Fig. 3A-3D, Fig. 5: dual pods 304 on each EMS set). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate multiple stimulation pods per TENS set in a device according to the teachings of Asseo, as taught by Fontaine, as this: a) would predictably stimulate tissue, and b) would enable treatment of more than one tissue regions at a time.
Claims 11, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0096027 by Asseo in view of US 20120059436 by Fontaine.
Regarding Claim 11, Asseo discloses a system for providing electrical stimulation (e.g. abstract: TENS system), the system comprising:
a computing device associated with a controlling user (e.g. ¶¶ 17, 21-22, Fig. 5: server 504, which can also be a desktop, laptop, tablet etc.); and
a plurality sets of electrical muscle stimulation (EMS) devices, wherein each set of the plurality sets of EMS devices is associated with a respective end user and a respective location, and wherein the plurality sets of EMS devices is in communication with the computing device and includes one EMS device (e.g. ¶ 37, Fig. 5: TENS modules 516A-516C with electrodes 518A-518C),
wherein each set of the plurality sets of EMS devices includes:
a first central body (e.g. abstract, ¶¶ 2, 5, 17-18: each TENS module/unit is a self-sufficient device that is capable of storing stimulation programs in a memory, processing the programs with a microcontroller, generating current stimulation according to the programs and providing the stimulation via the electrodes; Claim 1: a wireless TENS unit comprising an enclosure, and a microcontroller to execute one or more treatment plans) comprising:
a processing unit configured to execute a stimulation program (e.g. ¶¶ 25, 31, 39, Fig. 3: processing unit 314 stores and executes one or more treatment plans that “can be infinitely variable”; It is noted here that the claim does not require that any stimulation program is actually stored in the EMS device or anywhere else, it merely requires that processing unit of the EMS device would be able to execute the program); and
a pulse generator operatively coupled to the processing unit, wherein the pulse generator is configured to generate first electrical pulses in response to the stimulation program (e.g. ¶31, Fig. 3: pulse generator 302/306/308/310); and
and
a pad in communication with the first central body or the second central body, wherein the one or more pads are configured to be attached to the respective end user and transmit corresponding electrical pulses to stimulate the respective end user in accordance with the stimulation program,
wherein the plurality sets of EMS devices is configured to receive and implement the stimulation program, and wherein the stimulation program includes a plurality of predetermined stimulation programs and a tailored stimulation program which is based on respective user information and different from the plurality of predetermined stimulation programs (Again, it is noted here that the claim does not require that any stimulation program is actually stored in the EMS device or anywhere else, it merely requires that processing unit of the EMS device would be capable to execute the program(s). As such, so long as the processing unit would be capable of executing the claimed program(s), it meets the respective limitations; Asseo discloses that their TENS units are an improvement over the prior art which stored and applied “only” a limited or fixed number of pre-defined setting, see ¶¶ 6, 18, by also downloading, storing, displaying, making selectable and executing infinitely variable treatment plans from the server, including plans “customized to a particular user to obtain the maximum pain relief” and can be customized based on “history of a patient’s utilization of a TENS module and associated mode of operation”, and/or based on bio-information sensors, wherein the stored, fixed and tailored programs, being further customizable by the user, see e.g. ¶¶ 18-19, 23, 27-28, 33, and as such meet the claim).
Asseo does not explicitly disclose that each set comprises a second central body substantially similar to the first central body, wherein the second central body is configured to receive a broadcast command over the communication channel and generate second electrical pulses in response thereto.
However, Fontaine teaches an analogous EMS stimulation system which comprises multiple pod units to apply stimulation to different body parts at the same time (e.g. ¶¶ 1,64-65,87,107, Fig. 3A-3D, Fig. 5: dual pods 304 on each EMS set). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate multiple stimulation pods per TENS set in a device according to the teachings of Asseo, as taught by Fontaine, as this: a) would predictably stimulate tissue, and b) would enable treatment of more than one tissue regions at a time.
Regarding Claim 17, Asseo teaches the system of claim 11, wherein the computing device is configured to plan, manage, and track the stimulation program for each set of the plurality sets of EMS devices via a central server (e.g. ¶¶ 19,21-22,24-25,33,36-37: the plans can be customized via a server).
Regarding Claim 18, Asseo teaches the system of claim 11, wherein the stimulation program in each EMS device differs in a pulse width (e.g. ¶ 19: pulse width is varied in the treatment plans).
Regarding Claim 19, Asseo teaches the system of claim 11, wherein the stimulation program in each EMS device comprises a recovery program (e.g. ¶¶ 2-3, 19: plans are for back pain management).
Claims 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Asseo/Fontaine, as applied to Claim 11, and further in view of US 20140148871 by Southwell.
Regarding Claim 12, Asseo as modified in Claim 11 teaches the system of claim 11, yet does not explicitly disclose wherein the computing device is configured to authenticate whether the controlling user satisfies an authentication requirement, wherein the authentication requirement includes an authorized healthcare professional or an authorized service provider, and wherein the computing device comprises a mobile device configured to communicate with each set of the plurality sets of EMS devices in implementing the stimulation program.
However, Asseo teaches user authentication (e.g. ¶ 37), and Southwell teaches an analogous TENS system, which requires accreditation for the clinician to access software to reconfigure the TENS treatment (e.g. abstract, ¶ 111).
Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate the requirement for authentication on the clinician side (ie. the computer device) of a system according to the teachings of Asseo, as taught by Southwell, in order to predictably prevent unauthorized access to the computer device, and thus prevent unauthorized access to personal medical information and user settings.
Regarding Claim 13, Asseo as modified in Claim 12 teaches the system of claim 12, wherein the computing device is configured to communicate with each set of the plurality sets of EMS devices independent from each other (e.g. ¶¶ 36-37, Fig. 5: the plans are communicated through the internet, wherein each user is authorized for their personal access).
Regarding Claim 14, Asseo as modified in Claim 12 teaches the system of claim 13, wherein the computing device is configured to provide a first stimulation program to and collect data from a first set of EMS devices among the plurality sets of EMS devices located at a first location (e.g. ¶ 28: real-time feedback from bio-sensors).
Regarding Claim 15, Asseo as modified in Claim 12 teaches the system of claim 14, wherein the computing device is, after communication with the first set of EMS devices, configured to provide a second stimulation program to and collect data from a second set of EMS devices among the plurality sets of EMS devices located at a second location which is different from the first location (e.g. ¶ 28: real-time feedback from bio-sensors; As modified in Claim 11, each TENS set has two pods).
Regarding Claim 16, Asseo as modified in Claim 12 teaches the system of claim 15, wherein the first set of EMS devices and the second set of EMS devices are configured to communicate with each other (¶ 120: pods detect each other).
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, 8-11, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 7 of U.S. Patent No. 10,881,849 in view of Asseo.
Regarding Claim 1, Claim 1 of the issued patent discloses a system for providing electrical stimulation (Claim 1: A system for providing electrical stimulation to a user), the system comprising:
a set of EMS devices includes: a first central body comprising: a processing unit configured to execute a stimulation program; and a pulse generator operatively coupled to the processing unit, wherein the pulse generator is configured to generate first electrical pulses in response to the stimulation program; and one or more pads in communication with the first central body or the second central body, wherein the one or more pads are configured to be attached to the respective end user and transmit corresponding electrical pulses to stimulate the respective end user in accordance with the stimulation program (Claim 1: a pulse generator structurally configured to generate electrical pulses in response to execution of a stimulation program; one or more pads in communication with the pulse generator, the one or more pads structurally configured to attach to the user and to transmit the electrical pulses to stimulate the user according to the stimulation program; and a processor), wherein the plurality sets of EMS devices is configured to receive and implement the stimulation program, and wherein the stimulation program includes a plurality of predetermined stimulation programs and a tailored stimulation program which is based on respective user information and different from the plurality of predetermined stimulation programs (Claim 1: producing a tailored stimulation program for the user based on analysis of the information, the tailored stimulation program having a beginning and an end with a plurality of electrical pulses therebetween for transmitting to the user via the pulse generator, one or more of the plurality of electrical pulses including at least one of a customized pulse width and a customized duty cycle; presenting the tailored stimulation program alongside a plurality of predetermined stimulation programs for selection by the user, the tailored stimulation program different from the plurality of predetermined stimulation programs; and upon selection of the tailored stimulation program by the user, executing the tailored stimulation program with the pulse generator and the one or more pads).
Claim 1 of the issued patent does not disclose a computing device associated with a controlling user; and a plurality sets of EMS devices.
However, Asseo teaches an analogous TEN system which includes a central computing device for the clinician and multiple TENS unit sets in communication therewith to receive stimulation programs (e.g. ¶64, Fig. 5). Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate central control and multiple sets of TENS units in a system according to Claim 1 of the issued patent, as taught by Asseo, in order to predictably permit a clinician to treat multiple patients.
Regarding Claim 8, Claim 1 of the issued patent teaches the system of claim 1, wherein the computing device is configured to plan, manage, and track the one or more stimulation programs for each set of the plurality sets of EMS devices via a central server (Asseo, see ¶64, Fig. 5).
Regarding Claim 9, Claim 7 of the issued patent as modified in Claim 1 (Claim 7 depends on Claim 1) teaches the system of claim 1, wherein the one or more stimulation programs in each EMS device differ in at least one of a stimulation frequency, pulse width, duty cycle parameters, ramp up and down values, burst pulse parameters, waveform shape, or interphase interval (Claim 7: wherein each of the plurality of predetermined stimulation programs differ in at least one of a stimulation frequency, a pulse width, a duty cycle parameter, a ramp up and a ramp down value, and a burst pulse parameter).
Regarding Claim 10, Claim 1 of the system of claim 1, wherein the one or more stimulation programs in each EMS device comprises at least one of a drop foot assistance program, rehabilitation program, recovery program, relaxation program, or improved performance program (Asseo, ¶2: pain management).
Claim 11 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,881,849 in view of Asseo and US 20120059436 by Fontaine.
Regarding Claim 11, Claim 1 of the issued patent discloses a system for providing electrical stimulation (Claim 1: A system for providing electrical stimulation to a user), the system comprising:
a set of EMS devices includes: a first central body comprising: a processing unit configured to execute a stimulation program; and a pulse generator operatively coupled to the processing unit, wherein the pulse generator is configured to generate first electrical pulses in response to the stimulation program; and one or more pads in communication with the first central body or the second central body, wherein the one or more pads are configured to be attached to the respective end user and transmit corresponding electrical pulses to stimulate the respective end user in accordance with the stimulation program (Claim 1: a pulse generator structurally configured to generate electrical pulses in response to execution of a stimulation program; one or more pads in communication with the pulse generator, the one or more pads structurally configured to attach to the user and to transmit the electrical pulses to stimulate the user according to the stimulation program; and a processor), wherein the plurality sets of EMS devices is configured to receive and implement the stimulation program, and wherein the stimulation program includes a plurality of predetermined stimulation programs and a tailored stimulation program which is based on respective user information and different from the plurality of predetermined stimulation programs (Claim 1: producing a tailored stimulation program for the user based on analysis of the information, the tailored stimulation program having a beginning and an end with a plurality of electrical pulses therebetween for transmitting to the user via the pulse generator, one or more of the plurality of electrical pulses including at least one of a customized pulse width and a customized duty cycle; presenting the tailored stimulation program alongside a plurality of predetermined stimulation programs for selection by the user, the tailored stimulation program different from the plurality of predetermined stimulation programs; and upon selection of the tailored stimulation program by the user, executing the tailored stimulation program with the pulse generator and the one or more pads).
Claim 1 of the issued patent does not disclose a computing device associated with a controlling user; and a plurality sets of EMS devices.
However, Asseo teaches an analogous TEN system which includes a central computing device for the clinician and multiple TENS unit sets in communication therewith to receive stimulation programs (e.g. ¶64, Fig. 5). Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate central control and multiple sets of TENS units in a system according to Claim 1 of the issued patent, as taught by Asseo, in order to predictably permit a clinician to treat multiple patients.
Claim 1 of the issued patent does not explicitly disclose that each set comprises a second central body substantially similar to the first central body, wherein the second central body is configured to receive a broadcast command over the communication channel and generate second electrical pulses in response thereto.
However, Fontaine teaches an analogous EMS stimulation system which comprises multiple pod units to apply stimulation to different body parts at the same time (e.g. ¶¶ 1,64-65,87,107, Fig. 3A-3D, Fig. 5: dual pods 304 on each EMS set). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate multiple stimulation pods per TENS set in a device according to the teachings of Claim 1 of the issued patent, as taught by Fontaine, as this: a) would predictably stimulate tissue, and b) would enable treatment of more than one tissue regions at a time.
Regarding Claims 17, Claim 1 of the issued patent teaches the system of claim 11, wherein the computing device is configured to plan, manage, and track the one or more stimulation programs for each set of the plurality sets of EMS devices via a central server (Asseo, see ¶64, Fig. 5).
Regarding Claim 18, Claim 7 of the issued patent as modified in Claim 1 (Claim 7 depends on Claim 1) teaches the system of claim 11, wherein the one or more stimulation programs in each EMS device differ in at least one of a stimulation frequency, pulse width, duty cycle parameters, ramp up and down values, burst pulse parameters, waveform shape, or interphase interval (Claim 7: wherein each of the plurality of predetermined stimulation programs differ in at least one of a stimulation frequency, a pulse width, a duty cycle parameter, a ramp up and a ramp down value, and a burst pulse parameter).
Regarding Claim 19, Claim 1 of the system of claim 11, wherein the one or more stimulation programs in each EMS device comprises at least one of a drop foot assistance program, rehabilitation program, recovery program, relaxation program, or improved performance program (Asseo, ¶2: pain management).
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11,590,340 in view of Asseo.
Regarding Claim 1, Claim 18 of the issued patent discloses a system for providing electrical stimulation (Claim 18: A system for providing electrical stimulation to a user), the system comprising:
a set of EMS devices includes: a first central body comprising: a processing unit configured to execute a stimulation program; and a pulse generator operatively coupled to the processing unit, wherein the pulse generator is configured to generate first electrical pulses in response to the stimulation program; and one or more pads in communication with the first central body or the second central body, wherein the one or more pads are configured to be attached to the respective end user and transmit corresponding electrical pulses to stimulate the respective end user in accordance with the stimulation program (Claim 18: one or more electrical muscle stimulation devices, comprising: a pulse generator structurally configured to generate electrical pulses in response to execution of a stimulation program; and one or more pads in communication with the pulse generator, the one or more pads structurally configured to attach to a wearer and to transmit the electrical pulses to stimulate the wearer according to the stimulation program; an electronic platform hosted by a server and including a web-based user interface for managing stimulation programs; and a processor and a memory in communication with the electronic platform, the memory storing non-transitory computer executable code embodied in a non-transitory computer readable medium, that, when executed by the processor), wherein the plurality sets of EMS devices is configured to receive and implement the stimulation program, and wherein the stimulation program includes a plurality of predetermined stimulation programs and a tailored stimulation program which is based on respective user information and different from the plurality of predetermined stimulation programs (Claim 18: wherein the plurality of electrical stimulation sessions include a tailored stimulation program and a plurality of predetermined stimulation programs different from the tailored stimulation program; presenting two or more electrical stimulation sessions of the plurality of electrical stimulation sessions for selection by the user; upon selection of the two or more electrical stimulation sessions by the user, creating a schedule for implementation of the two or more electrical stimulation sessions at scheduled different times over a predetermined timeframe, the schedule customized for the wearer; providing the schedule to one or more of the user and the wearer from the electronic platform; and executing the stimulation program with the pulse generator and the one or more pads at the scheduled different times).
Claim 18 of the issued patent does not disclose a computing device associated with a controlling user; and a plurality sets of EMS devices.
However, Asseo teaches an analogous TEN system which includes a central computing device for the clinician and multiple TENS unit sets in communication therewith to receive stimulation programs (e.g. ¶64, Fig. 5). Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate central control and multiple sets of TENS units in a system according to Claim 18 of the issued patent, as taught by Asseo, in order to predictably permit a clinician to treat multiple patients.
Claim 11 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11,590,340 in view of Asseo and US 20120059436 by Fontaine.
Regarding Claim 11, Claim 18 of the issued patent discloses a system for providing electrical stimulation (Claim 18: A system for providing electrical stimulation to a user), the system comprising:
a set of EMS devices includes: a first central body comprising: a processing unit configured to execute a stimulation program; and a pulse generator operatively coupled to the processing unit, wherein the pulse generator is configured to generate first electrical pulses in response to the stimulation program; and one or more pads in communication with the first central body or the second central body, wherein the one or more pads are configured to be attached to the respective end user and transmit corresponding electrical pulses to stimulate the respective end user in accordance with the stimulation program (Claim 18: one or more electrical muscle stimulation devices, comprising: a pulse generator structurally configured to generate electrical pulses in response to execution of a stimulation program; and one or more pads in communication with the pulse generator, the one or more pads structurally configured to attach to a wearer and to transmit the electrical pulses to stimulate the wearer according to the stimulation program; an electronic platform hosted by a server and including a web-based user interface for managing stimulation programs; and a processor and a memory in communication with the electronic platform, the memory storing non-transitory computer executable code embodied in a non-transitory computer readable medium, that, when executed by the processor), wherein the plurality sets of EMS devices is configured to receive and implement the stimulation program, and wherein the stimulation program includes a plurality of predetermined stimulation programs and a tailored stimulation program which is based on respective user information and different from the plurality of predetermined stimulation programs (Claim 18: wherein the plurality of electrical stimulation sessions include a tailored stimulation program and a plurality of predetermined stimulation programs different from the tailored stimulation program; presenting two or more electrical stimulation sessions of the plurality of electrical stimulation sessions for selection by the user; upon selection of the two or more electrical stimulation sessions by the user, creating a schedule for implementation of the two or more electrical stimulation sessions at scheduled different times over a predetermined timeframe, the schedule customized for the wearer; providing the schedule to one or more of the user and the wearer from the electronic platform; and executing the stimulation program with the pulse generator and the one or more pads at the scheduled different times).
Claim 18 of the issued patent does not disclose a computing device associated with a controlling user; and a plurality sets of EMS devices.
However, Asseo teaches an analogous TEN system which includes a central computing device for the clinician and multiple TENS unit sets in communication therewith to receive stimulation programs (e.g. ¶64, Fig. 5). Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate central control and multiple sets of TENS units in a system according to Claim 18 of the issued patent, as taught by Asseo, in order to predictably permit a clinician to treat multiple patients.
Claim 18 of the issued patent does not explicitly disclose that each set comprises a second central body substantially similar to the first central body, wherein the second central body is configured to receive a broadcast command over the communication channel and generate second electrical pulses in response thereto.
However, Fontaine teaches an analogous EMS stimulation system which comprises multiple pod units to apply stimulation to different body parts at the same time (e.g. ¶¶ 1,64-65,87,107, Fig. 3A-3D, Fig. 5: dual pods 304 on each EMS set). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate multiple stimulation pods per TENS set in a device according to the teachings of Claim 18 of the issued patent, as taught by Fontaine, as this: a) would predictably stimulate tissue, and b) would enable treatment of more than one tissue regions at a time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at (571)272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MANOLIS PAHAKIS/Examiner, Art Unit 3796
Prosecution Insights