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 .
Claims 1-20 are pending. Claim 20 remains withdrawn. Claims 1-10 are rejected, as discussed in detail below. Claims 11-19 are allowed.
Response to Arguments
Applicant's arguments filed 8/7/26 have been fully considered. The arguments regarding Claims 1-10 are not persuasive. The amendments to Claim 11, make Claims 11-20 allowable.
Regarding Claims 1-10:
In short, Applicant alleges that the 102 rejection of claim 1 is essentially a product of an accounting error. It is not. The rejection of claim 1 merely reflects the breadth of the claim under the broadest reasonable interpretation. Claim 1 does not require four EMS devices, as Applicant essentially argues, just two. In fact, Claim 1 defines each set to include “at least one” EMS device, which includes just one EMS device. In other words, the broadest reasonable interpretation of claim 1 includes two sets, each set having one EMS device.
Applicant alleges that “Asseo discloses only one EMS device (TENS module) per user, not a plurality of devices per user” (Remarks, page 2). Applicant further explains “in Asseo … each of the three illustrated users …is associated with only a single TENS module …, together with the electrode(s) attached to that single module ... More specifically, Asseo discloses using one module, and its associated electrodes, per user. Each TENS module is thus itself a complete stimulation unit (with its own microcontroller, memory, and pulse- generating components) that the Examiner separately and erroneously maps to the claimed "central body." …The "electrode(s)" attached to that single module are nothing more than conductive pads through which that one module's pulses are delivered…Asseo does not disclose any user being associated with more than one TENS module.” (Remarks, page 2). These are not persuasive.
Claim 1 requires “a plurality of sets of …EMS devices”. A “plurality” is met by two, under the broadest reasonable interpretation (BRI). Each EMS device is defined by Claim 1, in “each EMS device…includes: a central body comprising…a processing unit…and a pulse generator…” and the second part of each EMS device is “one…pad”. Thus, an EMS device requires one central body (generator, processor) and one pad, as is correctly matched in the rejection. Most importantly, Claim 1 further defines each set. Claim 1 recites “each of which includes at least one EMS device”. What does “each of which” refer to? The complete limitation is “wherein each set…and wherein the plurality of sets of EMS devices are in communication with the computing device and each of which includes at least one EMS device”. There are three potential options here in terms of what “each of which” refers to: a) “the plurality”, b) “of sets”, and c) “the computing device”. Option c) does not make sense, because the claim does not require multiple computing devices. It only requires “a computing device” and makes no reference to another. For the same reason, option a) does not make sense, because the claim only requires “a plurality”, not multiple pluralities. Thus, “each of which” clearly refers to option b) “of sets”, reading as “each of the sets” or “each set” under BRI. This is further supported by line 3 of Claim 1, which refers to “each set”. Incidentally, this is the only reason that “each of which” is not rejected as indefinite; it can only refer to “each set”. Hence, under BRI, this “wherein each set …and wherein” clause includes the scope of “wherein each set…and wherein the plurality of sets of EMS devices are in communication with the computing device and each of the sets/each set includes at least one EMS device”. Clearly, “at least one EMS device” under BRI includes just one device. It follows that the scope of claim 1 under BRI includes that each set/ a set includes one EMS device. It is the drafting of the claim that explicitly defines each set to include just one EMS device. Therefore, Claim 1, which recites “a plurality of sets of EMS devices…, wherein each set…, and wherein the plurality of sets of EMS devices are…and each of which includes at least one EMS device” and “wherein each EMS device … includes …a central body…and one pad” would, in fact, be met by two sets of EMS devices, each set including one EMS device, each EMS device includes a central body and a pad. All that is required by Claim 1 is EMS SET A and EMS SET B, where SET A has a central body and one pad, and SET B has a central body and one pad. The claim defines the breadth of the scope of the “set” to include just one EMS device. It is not believed that Applicant argues that Asseo does not meet the foregoing actual scope of the claims under BRI. One last point that is further explained in the next paragraph, is that there is nothing in the claims or Asseo’s disclosure preventing one user from using multiple EMS devices, even overlapping devices. The system of Asseo is perfectly capable of allowing that use, even if the claims do not require it. Asseo teaches three or more devices (e.g. ¶¶24,37), yet that is not necessary to meet the claims. In response to applicant's arguments that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (e.g., “a plurality of devices per user”) are not recited in the rejected claim(s). Applicant is reminded that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
As noted above, Applicant’s position also relies heavily on intended use and the so-called “association with” the user. However, claim 1 is a product claim. There is nothing preventing any part of the system of Asseo to be used or otherwise associated with (which includes a mental association) one or multiple users. Nothing in the claims, and nothing in Asseo. As noted above, Claim 1 only requires one EMS device (one central body and one pad) and as part of its intended use to be capable of somehow being associated to a user. There is nothing in Asseo that would preclude one or multiple to be used or reused by one or more users, at will. In response to applicant's argument that each user is associated with only a single EMS device, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The same applies regarding dependent claims 2-10, which are grouped together, and for which Applicant does not present additional arguments.
Regarding Claims 11-20:
The amendments to Claim 11 have added that “the second central body is configured to receive a broadcast command from the first central body and generate second electrical pulses in response thereto”. This wireless communication between the two central bodies where one issues a broadcast command to the other for generating stimulation, is not taught by Asseo or Fontaine. Fontaine does teach a synchronization link between two EMS devices, yet teaches away from making the link wireless (e.g. ¶12).
Double Patenting:
The same apply to the arguments regarding the Double Patenting rejections, where Applicant presents the same arguments.
The amendments to the claims have resolved all other issues.
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 of sets of electrical muscle stimulation (EMS) devices, wherein each set of the plurality of sets of EMS devices is associated with a respective end user and a respective location, and wherein the plurality of sets of EMS devices are in communication with the computing device and each of which includes one 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 of 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 information of the respective end user 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 of 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 of 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 of 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 of 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 of 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.
However, Fontaine teaches an analogous EMS stimulation system which comprises multiple pod units to apply stimulation to different body parts at the same time, and also teaches that it was known for such pods to communicate with each other (e.g. ¶¶ 1,64-65,87,107, Fig. 1C,3A-3D, Fig. 5: dual pods 304 on each EMS set; ¶¶11-12, Fig. 1C: pods communicate with each other to synchronize stimulation). 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 EMS device 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. Furthermore, 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 communication between the pods, as taught by Fontaine, in order to prevent interference during operation of the EMS devices, as taught by Fontaine (¶11).
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, 8-10 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 of sets of EMS devices, each of which includes one EMS device.
However, Asseo teaches an analogous TEN system which includes a central computing device for the clinician and multiple TENS unit sets, each of which includes one EMS device, 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 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 computing device capable of being associated with a controlling user (Claim 18: 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); and a plurality of sets of electrical muscle stimulation (EMS) devices, wherein each set of the plurality of sets of EMS devices is capable of being associated with a respective end user and a respective location, and wherein the plurality of sets of EMS devices are capable of being in communication with the computing device and each of which includes one EMS device, wherein each EMS device 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 performs the steps of: …providing a plurality of electrical stimulation sessions for selection by a user on the web-based user interface, each of the plurality of electrical stimulation sessions configured for implementation on the one or more electrical muscle stimulation devices…and executing the stimulation program with the pulse generator and the one or more pads at the scheduled different times), 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).
Allowable Subject Matter
Claims 11-19 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not reasonably teach, suggest or render obvious, either alone or in combination, claim 11 taken as a whole. The amendments to Claim 11 have added that “the second central body is configured to receive a broadcast command from the first central body and generate second electrical pulses in response thereto”. This wireless communication between the two central bodies where one issues a broadcast command to the other for generating stimulation, is not taught by Asseo or Fontaine. Fontaine does teach a synchronization link between two EMS devices, yet teaches away from making the link wireless (e.g. ¶12).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796
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