DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Rejections under 35 USC 112
In regards to Applicant’s response filed 11/21/2025, the arguments regarding the rejections of claims 1-6 and 11 for indefiniteness are persuasive and the rejection previously set forth in the Non-Final Office Action filed 05/22/025 are withdrawn.
As further detailed in the Claim Interpretation section below, Examiner notes that the limitation in claim 1, “the plurality of electrodes will simultaneously contact transversus abdominus (TrA) muscles and lumbar multifidus (LM) muscles,” is regarded as functional language as the contraction of the transversus abdominus and lumbar multifidus muscles do not impart any further structural limitation over the device.
Regarding claim 11, any device which can be placed in any three or more positions, and maintain any portion of its shape within 5% of the unit scale used while under the influence of gravity, as it is experienced on Earth, will be interpreted to meet the claim limitation.
Rejections under 35 USC 103
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Due to the amendments to the independent claims, new grounds of rejection in view of Coleman, Fassih (US 20100082088 A1), and Shahriari (US 20190167988 A1) or alternatively Daniels et al (US 20210244941 A1) are detailed below.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 07/19/2023 and 10/08/2025 have been considered by the examiner.
Claim Objections
Claim 4 objected to because of the following informalities: “two equal sided electrodes” should read “two equal sized electrodes,” support found for this limitation in paragraph 0051 of the Specification. Appropriate correction is required.
Claim 12 objected to because of the following informalities: “wherein the garment the garment is configured to …” should read “wherein the garment is configured to.” Appropriate correction is required.
Claim Interpretation
Regarding claim 1, Examiner is interpretating the limitation “the plurality of electrodes will simultaneously contact transversus abdominus (TrA) muscles and lumbar multifidus (LM) muscles,” as functional language as the contraction of the transversus abdominus and lumbar multifidus muscles do not impart any further structural limitation over the device.
Regarding claim 11, any device which can be placed in any three or more positions, and maintain any portion of its shape within 5% of the unit scale used while under the influence of gravity, as it is experienced on Earth, will be interpreted to meet the claim limitation.
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4-6, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al (US 20190298998 A1) in view of Fassih et al (US 20100082088 A1) and Shahriari et al (US 20190167988 A1).
Regarding claim 1, Coleman teaches a system for alleviating chronic lower back pain comprising:
a wearable garment (605),
a controller (675),
a panel (610 and/or 620), and
a plurality of electrodes (615 and/or 625);
wherein the panel comprises at least one of the plurality of electrodes wherein the panel is configured to electrically couple to at least one of the plurality of electrodes (see [0164]; panel 620 can include one or more coupled or integrated back electrodes 625);
wherein the plurality of electrodes are positioned on the wearable garment such that a neuromuscular electrical stimulation (NMES) pulse to each of the plurality of electrodes will simultaneously contract transversus abdominis (TrA) muscles and lumbar multifidus (LM) muscles (see annotated Figs. 2Y-2Z below, where the positioning of front panel 610 is configured to deliver a pulse to the transverse abdominus muscles and back panel 620 is configured to deliver a pulse to the lumbar multifidus muscles); and
wherein the controller is configured to the system is configured to execute a NMES activation protocol and/or a transcutaneous electrical stimulation (TENS) activation protocol (see [0255]; in some embodiments, the system can perform NMES/TENS stimulation).
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Coleman is silent regarding wherein the panel comprises a foam substrate that includes printed flexible wires configured to electrically couple to at least one of the plurality of electrodes
wherein a front side of the panel comprises a dock configured to removably couple to the controller and securely couple the controller in a fixed position; and
wherein the controller is configured to the system is configured to execute a NMES activation protocol with a transcutaneous electrical stimulation (TENS) activation protocol in a single therapeutic session.
Fassih teaches a garment (20) for providing an electrical stimulation to a target site (Fassih [0014]), comprising a panel (see Fig. 4a where the panel is considered to be the portion of garment 20 in between the attachment portions 202),
wherein the panel comprises a foam substrate (see Fassih [0045]; the garment may be made of a variety of materials that stabilize the electrode, including fabrics, felts, open-cell foam, and others) that includes printed flexible wires configured to electrically couple to at least one of the plurality of electrodes (see Fassih Figs. 4a-b; electrode 201 between foam layers 200 of garment 20, [0089-0093]; for construction of electrodes, including using printed conductive inks)
wherein a front side of the panel comprises a dock (203) configured to removably couple to the controller and securely couple the controller in a fixed position (see Fassih [0101]; electrical snap 203 provides electrical connectivity between electrode 201 and the outside surface of the garment, [0104]; negative snap 310 of the power delivery unit 20 is connected to the armband via snap 203).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the electrode housing panel of Coleman’s garment with the layered panel including a foam substrate and a controller dock as taught by Fassih. One of ordinary skill in the art would have been motivated to make this modification in order to house the electrodes in a manner which makes the treatment tolerable for an extended time and allows for easy adjustment of the therapy parameters using the docked controller (Fassih [0012]).
Shahriari teaches a therapeutic garment (180) for providing electrical stimulation to a user where a controller (675) is configured to execute a NMES activation protocol with a transcutaneous electrical stimulation (TENS) activation protocol in a single therapeutic session (see Shahriari [0032]; the apparatus can substantially simultaneously provide neuromuscular electrical therapy, “LAMES,” and/or transcutaneous electrical nerve stimulation, “TENS,” therapy).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Coleman’s therapeutic garment for delivering electrical stimulation to provide NMES and TENS therapy in a single session as taught by Shahriari. One of ordinary skill in the art would have been motivated to make this modification in order to reap the benefits of both kinds of therapy for the rehabilitation and pain relief of the user.
Regarding claim 2, Coleman, Fassih, and Shahriari teach the system of claim 1. Coleman is silent regarding wherein the controller is configured to execute TENS and NMES programs to a same electrode simultaneously.
Shahriari teaches wherein the controller (675) is configured to execute TENS and NMES programs to a same electrode simultaneously (see Shahriari [0032]; any of the apparatus, assemblies, components can substantially simultaneously provide neuromuscular electrical therapy, “LAMES,” and/or transcutaneous electrical nerve stimulation, “TENS,” therapy, where it is assumed that the stimulation electrodes are considered to be a component of the system).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Coleman’s therapeutic garment for delivering electrical stimulation to provide NMES and TENS therapy in a single session as taught by Shahriari. One of ordinary skill in the art would have been motivated to make this modification in order to reap the benefits of both kinds of therapy for the rehabilitation and pain relief of the user in the same targeted area.
Regarding claim 4, Coleman, Fassih, and Shahriari teach the system of claim 1. Coleman further teaches wherein the plurality of electrodes includes two equal sized electrodes (see Coleman Figs. 2Y-2Z where two of electrodes 615/625 are of equal size). Coleman also teaches in the embodiments of Fig. 2T, a first pair of electrodes 560 that have an elongated shape (and are of equal size) and a second pair of electrodes 565 which are of a second equal size. It can be appreciated that it would have been an obvious matter of design choice to include electrodes of the plurality of electrodes wherein two electrodes are elongated and two equal sized electrodes, since such a modification would have involved a mere change in the size/shape of a component, and the shape and size of the desired electrode may change based on the desired stimulation area. A change in size/shape has been recognized to be within the level of ordinary skill in the art. See MPEP 2144.04(IV).
Regarding claim 5, Coleman, Fassih, and Shahriari teach the system of claim 1. Coleman further teaches wherein the wearable garment (605) is configured to secure the panel (610 and/or 620) in position such that at least one of the plurality of electrodes (615 and/or 625) contracts at least one of the TrA muscles and the LM muscles when an NMES pulse is applied to at least one of the plurality of electrodes. See annotated Figs. 2Y-2Z below.
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Regarding claim 6, Coleman, Fassih, and Shahriari teach the system of claim 1. Coleman further teaches the system comprising:
a plurality of panels (610 and 620);
wherein each of the plurality of panels comprise electrical contacts configured to physically couple to at least one of the plurality of electrodes (see [0164]; electrodes can be coupled or integrated into brace panel 610);
wherein each of the plurality of panels are configured to electrically couple to at least one of the plurality of electrodes (see [0165]; electronic components can be integrated into one or more modules of a brace system); and
wherein the wearable garment is configured to secure each of the plurality of panels in a position such that an NMES pulse contracts the TrA muscles and/or the LM muscles. See annotated Figs. 2Y-2Z below.
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Regarding claim 14, Coleman teaches a system for alleviating chronic lower back pain comprising:
a panel (610 and/or 620),
a plurality of electrodes (615 and/or 625), and
a controller (675);
wherein the back side panel comprises the plurality of electrodes (see [0164]; panel 620 can include one or more coupled or integrated back electrodes 625); and
wherein the controller is configured to execute a neuromuscular electrical stimulation (NMES) program configured to generate one or more NMES pulses to each of the plurality of electrodes (see [0166]; the controller 675 is configured to apply at least one stimulation sense pulse to the patient’s tissue using at least one electrode);
wherein the one or more NMES pulses comprise a transversus abdominis (TrA) pulse configured to contract TrA muscles; and
wherein the one or more NMES pulses comprise a lumbar multifidus (LM) pulse configured to contract LM muscles. See annotated Figs. 2Y-2Z below.
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Coleman is silent regarding wherein the panel comprises a front side foam panel and a back side foam panel;
wherein the panel includes printed flexible wires positioned between the front side foam panel and the back side foam panel;
wherein the front side foam panel comprises a dock configured to removably couple to the controller; and
wherein the controller is configured to the system is configured to execute a NVIES activation protocol with a transcutaneous electrical stimulation (TENS) activation protocol in a single therapeutic session.
Fassih teaches a garment (20) for providing an electrical stimulation to a target site (Fassih [0014]), comprising a panel (see Fig. 4a where the panel is considered to be the portion of garment 20 in between the attachment portions 202),
wherein the panel comprises a foam substrate (see Fassih [0045]; the garment may be made of a variety of materials that stabilize the electrode, including fabrics, felts, open-cell foam, and others) that includes printed flexible wires configured to electrically couple to at least one of the plurality of electrodes (see Fassih Figs. 4a-b; electrode 201 between foam layers 200 of garment 20, [0089-0093]; for construction of electrodes, including using printed conductive inks)
wherein a front side of the panel comprises a dock (203) configured to removably couple to the controller and securely couple the controller in a fixed position (see Fassih [0101]; electrical snap 203 provides electrical connectivity between electrode 201 and the outside surface of the garment, [0104]; negative snap 310 of the power delivery unit 20 is connected to the armband via snap 203).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the electrode housing panel of Coleman’s garment with the layered panel including a foam substrate and a controller dock as taught by Fassih. One of ordinary skill in the art would have been motivated to make this modification in order to house the electrodes in a manner which makes the treatment tolerable for an extended time and allows for easy adjustment of the therapy parameters using the docked controller (Fassih [0012]).
Shahriari teaches a therapeutic garment (180) for providing electrical stimulation to a user where a controller (675) is configured to execute a NMES activation protocol with a transcutaneous electrical stimulation (TENS) activation protocol in a single therapeutic session (see Shahriari [0032]; the apparatus can substantially simultaneously provide neuromuscular electrical therapy, “LAMES,” and/or transcutaneous electrical nerve stimulation, “TENS,” therapy).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Coleman’s therapeutic garment for delivering electrical stimulation to provide NMES and TENS therapy in a single session as taught by Shahriari. One of ordinary skill in the art would have been motivated to make this modification in order to reap the benefits of both kinds of therapy for the rehabilitation and pain relief of the user.
Regarding claims 15 and 16, Coleman, Fassih, and Shahriari teach the system of claim 14. Coleman further teaches wherein the controller (675) is configured to:
execute, by one or more processors (702), the TrA pulse;
stop, by the one or more processors, the TrA pulse;
execute, by the one or more processors, the LM pulse;
stop, by the one or more processors, the LM pulse; and
execute, by the one or more processors, the TrA pulse and the LM pulse simultaneously.
See [0166] wherein Coleman describes a method by which the controller applies at least one stimulation pulse to the patient using at least one electrode and adjustably applies the at least one stimulation pulse based at least in part on the measured power dissipation measured. Since the controller is configured to execute the pulses as taught above, it can be understood that the controller is able to execute the commands of executing and stopping a pulse as taught in the claim. See also [0169] wherein Coleman teaches at least one processor 702 that executes instructions as communicated by the system 700, including control 675.
Regarding claims 17 and 18, Coleman, Fassih, and Shahriari teaches the system of claim 14. Coleman is silent regarding wherein the controller is configured to execute TENS and NMES programs to a same electrode simultaneously.
Shahriari teaches wherein the controller (675) is configured to execute TENS and NMES programs to a same electrode simultaneously (see Shahriari [0032]; any of the apparatus, assemblies, components can substantially simultaneously provide neuromuscular electrical therapy, “LAMES,” and/or transcutaneous electrical nerve stimulation, “TENS,” therapy, where it is assumed that the stimulation electrodes are considered to be a component of the system).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Coleman’s therapeutic garment for delivering electrical stimulation to provide NMES and TENS therapy in a single session as taught by Shahriari. One of ordinary skill in the art would have been motivated to make this modification in order to reap the benefits of both kinds of therapy for the rehabilitation and pain relief of the user in the same targeted area.
Regarding claim 19, Coleman, Fassih, and Shahriari teach the system of claim 14. Coleman further teaches the system comprising a garment (600), and
one or more panels (610 and 620);
wherein the controller is configured to couple the garment (see Coleman [0146]; the controllers can be integrated or coupled with stays, joints, pivots, or wraps of the brace system);
wherein the one or more panels are secured in one or more positions by the garment (see Coleman Figs. 2Y-2Z, [0164]; main body 605 of garment 600 securing panels 610 and 620 in the desired position on the user);
wherein the one or more positions are configured to deliver the TrA pulse and/or the LM pulse (see Coleman Figs. 2Y-2Z).
Coleman is silent regarding wherein the controller is configured to electrically couple to at least one of the one or more panels;
wherein the garment comprises one or more mechanical couplings configured to removably secure the one or more panels in one or more positions.
Fassih teaches wherein the controller is configured to electrically couple to at least one of the one or more panels (see Fassih [0101]; electrical snap 203 provides electrical connectivity between electrode 201 and the outside surface of the garment, [0104]; negative snap 310 of the power delivery unit 20 is connected to the armband via snap 203); and
wherein the garment comprises one or more mechanical couplings configured to removably secure the one or more panels in one or more positions (see Fassih Fig. 4a, [0101]; Velcro portions 202 of garment 20 are fitted for the user to secure the electrode panel in a desired position).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the electrode housing panel of Coleman’s garment with one or more mechanical couplings to secure the electrode panel(s) and a controller dock as taught by Fassih. One of ordinary skill in the art would have been motivated to make this modification in order to house the electrodes in a manner which makes the treatment tolerable for an extended time and allows for easy adjustment of the therapy parameters using the docked controller (Fassih [0012]).
Regarding claim 20, Coleman, Fassih, and Shahriari teach the system of claim 19. Coleman is silent regarding wherein the one or more panels comprise an electrical circuit between the front side foam panel and the back side foam panel configured to deliver electrical pulses to each of the plurality of electrodes.
Fassih teaches wherein the one or more panels (200) comprise an electrical circuit (201) between the front side foam panel and the back side foam panel (see Fassih Fig. 4b where electrode 201 having an electrical circuit is in between two panels 200) configured to deliver electrical pulses (see Fassih [0061]; power delivery unit delivers and controls electricity flow to the electrodes) to each of the plurality of electrodes (see Fassih [0044]; a first and second electrode may be combined into a single garment).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the panel of Coleman’s garment with the electrical circuit positioned between a front and back foam layer as taught by Fassih. One of ordinary skill in the art would have been motivated to make this modification in order to house the electrodes in a manner which makes the treatment tolerable for an extended time and allows for easy adjustment of the therapy parameters using the docked controller (Fassih [0012]).
12. Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al (US 20190298998 A1) in view of Fassih et al (US 20100082088 A1).
Regarding claim 7, Coleman teaches a system for alleviating chronic lower back pain comprising:
an electrode panel (610 and/or 620);
wherein the electrode panel comprises a plurality of electrodes (electrodes 615 and 625), wherein one or more electrodes of the plurality of electrodes are integrated into the panel (see Coleman [0164]; panel 620 can include one or more coupled or integrated back electrodes 625).
Coleman is silent regarding wherein the electrode panel comprises a front side foam panel and a back side foam panel;
wherein the electrode panel includes printed flexible wires positioned between the front side foam panel and the back side foam panel;
wherein the front side foam panel comprises a dock configured to removably couple to a controller; and
wherein the back side foam panel comprises the plurality of electrodes.
Fassih teaches a garment (20) for providing an electrical stimulation to a target site (Fassih [0014]), comprising a panel (see Fig. 4a where the panel is considered to be the portion of garment 20 in between the attachment portions 202),
wherein the panel comprises a front side foam panel and a back side foam panel (see Fassih [0045]; the garment may be made of a variety of materials that stabilize the electrode, including fabrics, felts, open-cell foam, and others, Fig. 4b showing a front side foam panel 200 located on the top side as pictured and a back side foam panel 200 located on the bottom side as pictured);
wherein the panel includes printed flexible wires positioned between the front side foam panel and the back side foam panel (see Fassih Figs. 4a-b; electrode 201 between foam layers 200 of garment 20, [0089-0093]; for construction of electrodes, including using printed conductive inks)
wherein a front side foam panel comprises a dock (203) configured to removably couple to a controller (see Fassih [0101]; electrical snap 203 provides electrical connectivity between electrode 201 and the outside surface of the garment, [0104]; negative snap 310 of the power delivery unit 20 is connected to the armband via snap 203).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the electrode housing panel of Coleman’s garment with the layered panel including a foam substrate and a controller dock as taught by Fassih. One of ordinary skill in the art would have been motivated to make this modification in order to house the electrodes in a manner which makes the treatment tolerable for an extended time and allows for easy adjustment of the therapy parameters using the docked controller (Fassih [0012]).
Regarding claim 8, Coleman and Fassih teach the system of claim 7. Coleman further teaches wherein the mechanical connections are configured to position the plurality of electrodes (615) such that a neuromuscular electrical stimulation (NMES) pulse to each of the plurality of electrodes will contract transversus abdominis (TrA) muscles. See annotated Fig. 2Y below.
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Regarding claim 9, Coleman and Fassih teach the system of claim 8. Coleman further teaches wherein the mechanical connections are configured to position the plurality of electrodes (625) such that a neuromuscular electrical stimulation (NMES) pulse to each of the plurality of electrodes will contract lumbar multifidus (LM) muscles. See annotated Figs. 2Y-2Z below.
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Regarding claim 10, Coleman and Fassih teach the system of claim 9. Coleman further teaches a controller (675) is configured to:
execute, by one or more processors (702), a TrA pulse;
stop, by the one or more processors, the TrA pulse;
execute, by the one or more processors, an LM pulse;
stop, by the one or more processors, the LM pulse; and
execute, by the one or more processors, the TrA pulse and the LM pulse, simultaneously.
See [0166] wherein Coleman describes a method by which the controller applies at least one stimulation pulse to the patient using at least one electrode and adjustably applies the at least one stimulation pulse based at least in part on the measured power dissipation measured. Since the controller is configured to execute the pulses as taught above, it can be understood that the controller is configured to execute the commands of executing and stopping a pulse as taught in the claim. See also [0169] wherein Coleman teaches at least one processor 702 that executes instructions as communicated by the system 700, including control 675.
Claims 7 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniels et al (US 20210244941 A1), optionally in view of Fassih et al (US 20100082088 A1).
Regarding claim 7, Daniels teaches a system for alleviating chronic lower back pain comprising:
an electrode panel (see Figs. 34-36);
wherein the electrode panel comprises a plurality of electrodes (see Fig. 35; plurality of electrodes);
wherein the electrode panel comprises a front side panel and a back side panel (see Figs. 34-35 showing opposing sides of a back side panel and Fig. 36 showing a front side panel)
wherein the electrode panel includes printed flexible wires positioned between the front side panel and the back side panel (see Figs. 34-36 where Fig. 36 shows assembled panel with flexible wires pictured in Fig. 34 in between the two panels, [0278-0280]; the dry electrodes are disposed on the user facing side, Fig. 35, to contact the skin of the user, so it can be appreciated that the side of the back panel opposite the user side, Fig. 34, where the flexible wires are, is positioned between the front and back panels);
wherein the front side panel comprises a dock configured to removably couple to a controller (see Figs. 9-11, [0274-0275]; front side panel having male snaps which connect with female snaps on the TENS unit so they can be removably connected); and
wherein the back side foam panel comprises the plurality of electrodes (Fig. 35, [0287]). See annotated Figs. 34-36 below.
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It can be appreciated that Daniels discloses the claimed invention except for wherein the front side panel and back side panel of the electrode panel are made out of foam. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system taught by Daniels to fabricate the electrode panels out of foam. Applicant has not disclosed that the claimed foam material provides an advantage, is used for a particular purpose, or solves a stated problem. A persom having ordinary skill in the art would have expected Applicant’s invention to perform equally well with an electrode panel made out of a stretchable fabric material as taught by Daniels because it provides similar support for the electrodes as the claimed foam panel. Therefore, it would have been an obvious matter of design choice to modify Daniels to obtain the invention as specified in the claims.
Additionally, Examiner points to the prior art of Fassih which was referenced above in the rejection of claim 7 in view of Coleman and Fassih. Fassih teaches an electrode panel having a front and back panel made of foam (see Fassih [0045]; the garment may be made of a variety of materials that stabilize the electrode, including fabrics, felts, open-cell foam, and others, Fig. 4b showing a front side foam panel 200 located on the top side as pictured and a back side foam panel 200 located on the bottom side as pictured). The prior art of Fassih provides further justification that the material of the electrode panel is simply a matter of design choice and there is no difference in the reasonable expectation of success based on the difference in material.
Regarding claim 11, Daniels (optionally in view of Fassih), teaches the system of claim 7, wherein the electrode panel comprises rigidity properties and flexibility properties;
wherein the rigidity properties enable the electrode panel to maintain a same shape under an influence of gravity when rotated to various positions (see [0266-0269]; where the foam block urging member keeps in integrity of the electrode panel to ensure desired positioning and proximity to user); and
wherein the flexibility properties enable the electrode panel to bend an amount sufficient to ensure each of the plurality of electrodes contact skin to contract transversus abdominis (TrA) muscles and/or lumbar multifidus (LM) muscles when the plurality of electrodes are connected to the electrode panel (see [0266-0269]; where an elastic fabric urging member may provide a custom fit for a particular user’s body, preference, or specific application of the system, which may be around the abdomen of a user as pictured in Fig. 7).
Regarding claim 12, Daniels (optionally in view of Fassih) teaches the system of claim 7, wherein the electrode panel comprises fingers in an area of each of the plurality of electrodes (Fig. 34); and
wherein a shape of the fingers are configured to allow for flexing without bunching (see Fig. 34, [0287]; where the stretchable wiring leads are disposed on a surface of the back electrode panel allowing them to flex and conform to the movement of the garment around a user’s body part).
Regarding claim 13, Daniels (optionally in view of Fassih) teaches the system of claim 12, further comprising:
a garment (Figs. 5-8);
wherein the garment comprises a strap (see Figs. 5-8 showing the garment using a strap to secure itself to the user);
wherein the garment is configured to secure a back electrode panel in position while allowing an abdominal electrode panel to be adjusted (see Figs. 34-36, [0287]; it can be appreciated that due to the nature of the electrode configuration and the flexibility provided by the stretchable fabric of the garment, that the garment would be able to be held securely with pressure by the user to hold the electrode portion in the back in place while positioning a front electrode portion);
wherein the controller is configured to electrically couple to the electrode panel via the dock (see Figs. 9-11, [0274-0275]; front side panel having male snaps which connect with female snaps on the TENS unit so they can be removably connected); and
wherein the garment comprises one or more mechanical couplings configured to removably secure the controller and/or the electrode panel in a secure position (see [0274-0275]; snap connectors to secure the TENS unit, [0280]; connection snaps on removably fixable electrodes).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792