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 .
The amendment filed on July 30, 2026 has been received and considered. By this amendment, claims 200, 202, 210, 215, 217, and 219 are amended and claims 200-219 are now pending in the application.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 200-213 and 215-219 are rejected under 35 U.S.C. 103 as being unpatentable over Shloznikov (U.S. 2003/0191506, previously cited) in view of Rosenbluth et al. (U.S. 2017/0014625). Regarding claim 200, Shloznikov discloses a device comprising: a band 50; a first stimulating electrode configured to stimulate a first nerve of the user (see annotated Figure 3 below, where it is respectfully submitted that the electrodes on one end of the device would be configured to stimulate a first nerve); a first set of common electrodes comprising a first common electrode and a second common electrode (see annotated Figure 3 below); wherein the first common electrode and the second common electrode of the first set of common electrodes are positioned on opposite sides of the first stimulating electrode on the band (see annotated Figure 3 below); wherein the first stimulating electrode and the first set of common electrodes are configured to create a first stimulation current path configured to activate the first nerve during a first time frame (the path formed for each of electrode sets 60a to 60t shown in annotated Figure 3); a second stimulating electrode configured to stimulate a second nerve of the user (see annotated Figure 3 below, where it is respectfully submitted that the electrodes on an end opposite that of the first stimulating electrode would be configured to stimulate a second nerve); a second set of common electrodes comprising a first common electrode and a second common electrode (see annotated Figure 3 below); wherein the first common electrode and the second common electrode of the second set of common electrodes are positioned on opposite sides of the second stimulating electrode on the band (see annotated Figure 3 below); wherein the second stimulating electrode and the second set of common electrodes are configured to create a second stimulation current path configured to activate the second nerve during a second time frame (the path formed for each of electrode sets 60a to 60t shown in annotated Figure 3); wherein the first stimulating electrode and the second stimulating electrode are spaced from one another along a length of the band (the electrodes spaced along the band, as shown in the annotated Figure 3 below, would include first and second electrodes spaced from one another along a length of the band such that they would stimulate first and second nerves); wherein during the second time frame, the device can maintain or change an activation state of one or more of any of the stimulating electrodes and/or one or more of any of the common electrodes (this capability is possible using the signal generator 24 and switches 26 shown in Figure 2 and described in paragraph [0050]); and wherein one or more of the stimulation current paths and/or a number of stimulation current paths created by the device during the first time frame is configured to change during the second time frame (the “sweeping” of stimulation current described in paragraph [0057] is considered to satisfy the limitation, as the sweeping of the current occurs over a period of time, which could be broken into first and second time frames). However, while Shloznikov discloses that the band is flexible and made of rubber (“the platform 50 is made from a flexible, non-conductive material, such as rubber or mylar, which permits the plurality of electrodes 60 to substantially conform to a surface of the user”, paragraph [0032]), Shloznikov fails to explicitly disclose that the band is configured to, when worn, at least partially encircle a limb of a user or when the band is worn, the first and second stimulating electrode are circumferentially spaced from one another to stimulate the first and second nerves of the user. Rosenbluth teaches a peripheral nerve stimulator that includes an array of electrodes 1500 that “can be integrated into a sleeve” (paragraph [0187]) such that the electrodes are easy to quickly apply and enable patients to use it discretely and comfortably (see paragraph [0185]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Shloznikov such that the electrodes are integrated into a sleeve, as taught by Rosenbluth, in order to make such electrodes easy to quickly apply and enable patients to use it discretely and comfortably.
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Regarding claim 201, Shloznikov discloses that the device is configured to change a parameter of a stimulation signal sent to one or more of any of the stimulating electrodes between the first and second time frames to create one or more stimulation channels (see paragraphs [0057]-[0058] and Table A, which shows sweeps 1-3 with changing parameters).
Regarding claim 202, Shloznikov discloses that the parameter of the stimulation signal comprises at least one of a stimulation amplitude, a frequency, a patterned burst stimulation, an interval, a time of day, an individual session or a cumulative on time (“One advantage of the above is that the application of the base wave b, at the different frequencies, namely 4 Hz, 2 Hz and 77 Hz, will have different beneficial effects to the patient.”, paragraph [0058]).
Regarding claim 203, Shloznikov discloses that the device is configured to activate different stimulation current paths during the first time frame as compared to the second time frame (sweep 1 is in first direction 41 and sweep 2 is in second direction 42, as described in paragraph [0057], and therefore, the stimulation current path during the first time frame of sweep 1 is different from the stimulation current path during the second time frame of sweep 2).
Regarding claim 204, Shloznikov discloses that the device is configured to change one or more parameters of a stimulation signal sent by the first stimulating electrode and/or the second stimulating electrode during the first time frame as compared to the second time frame (see paragraphs [0057]-[0058] and Table A, which shows sweeps 1-3 with changing parameters).
Regarding claim 205, Shloznikov discloses that the parameter comprises a pattern, wherein the pattern comprises a burst stimulation pattern (see Table A, which provides “Bursts per set of electrodes” and “Bursts per sweep (20 sets of electrodes 60)”, which are considered to claimed “burst stimulation pattern”).
Regarding claim 206, Shloznikov discloses that the parameter comprises a stimulation amplitude (“the base wave bw will decrease from its maximum value bmax of about positive 50V to its minimum value bmin of about negative 17V”, paragraph [0042]).
Regarding claim 207, Shloznikov discloses that the parameter comprises a stimulation frequency (“the application of the base wave b, at the different frequencies, namely 4 Hz, 2 Hz and 77 Hz”, paragraph [0058], and Table A).
Regarding claim 208, Shloznikov discloses that the device is configured to activate the first set of common electrodes to create multiple stimulation current paths between the first stimulating electrode and the first set of common electrodes (as can be seen from annotated Figure 3 above, the current travels from 1 to 2 to 3 and from 4 to 5 to 6 and, therefore, there are at least 2 paths in each set of common and stimulation electrode groups).
Regarding claim 209, Shloznikov discloses that the device is configured to activate the second set of common electrodes to create multiple stimulation current paths between the second stimulating electrode and the second set of common electrodes (as can be seen from annotated Figure 3 above, the current travels from 1 to 2 to 3 and from 4 to 5 to 6 and, therefore, there are at least 2 paths in each set of common and stimulation electrode groups).
Regarding claim 210, Shloznikov discloses that the device is configured to activate the first set of common electrodes while the second set of common electrodes is deactivated, and wherein the device is configured to activate the second set of common electrodes while the first set of common electrodes is deactivated (the sweep described in paragraphs [0057]-[0058] results in the electrodes on one end of the device being active while the electrodes on the opposite end of the device are inactive).
Regarding claim 211, it is respectfully submitted that the claim recitation “a level of activation of the first nerve or the second nerve caused by the stimulation current paths varies depending on a proximity of the first nerve or the second nerve to the stimulation current paths” fails to further define the claimed invention over that of the prior art because it is recited in such a way that it is an inherently natural result. It is suggested to require a positive recitation of a configuration of the device that would result in such a level of activation, similar to “wherein the device is configured to vary a parameter of a stimulation signal sent to one or more of any of the stimulation electrodes based on a proximity of the first or the second nerve to a resultant stimulation current path”.
Regarding claims 22 and 213, Shloznikov discloses the invention substantially as claimed, including that the first stimulating electrode and the first set of common electrodes include at least three electrodes positioned transcutaneously and the second stimulating electrode and the second set of common electrodes include at least three electrodes positioned transcutaneously (see annotated Figure 3 above showing 3 electrodes in each grouping and “the present invention may be used for different types of therapies, including relief of pain, relief of stress, electronic acupuncture and transcutaneous electrical nerve stimulation (TENS)”, paragraph [0079]). Further, Shloznikov discloses that the device be attached to a region of the user, such as an arm or leg (“The strap 410 can be used to strap the flexible platform 350 to a region of the user, such as an arm or leg.”, paragraph [0075]), but fails to disclose the specific targeting of a median nerve and a radial nerve, as claimed. It is well known that there are five main nerves in the arm, the axillary, musculocutaneous, radial, ulnar, and median nerves. It would have been obvious to one having ordinary skill in the art before the effective filing date to choose between these nerves in the arm to provide the transcutaneous electrical nerve stimulation of Shloznikov to target a median and a radial nerve, as it has been held that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 215, Shloznikov discloses a device comprising: a band 50; a first stimulating electrode configured to stimulate a first nerve of the user (see annotated Figure 3 above, where it is respectfully submitted that the electrodes on one end of the device would be configured to stimulate a first nerve); a first common electrode (see annotated Figure 3 above); wherein the first common electrode is positioned adjacent the first stimulating electrode on the band (see annotated Figure 3 above); wherein the first stimulating electrode and the first common electrode are configured to create a first stimulation current path configured to activate the first nerve during a first time frame (the path formed for each of electrode sets 60a to 60t shown in annotated Figure 3); a second stimulating electrode configured to stimulate a second nerve of the user (see annotated Figure 3 above, where it is respectfully submitted that the electrodes on an end opposite that of the first stimulating electrode would be configured to stimulate a second nerve); a second common electrode (see annotated Figure 3 above); wherein the second common electrode is positioned adjacent the second stimulating electrode on the band (see annotated Figure 3 above); wherein the second stimulating electrode and the second common electrode are configured to create a second stimulation current path configured to activate the second nerve during a second time frame (the path formed for each of electrode sets 60a to 60t shown in annotated Figure 3); wherein the first stimulating electrode and the second stimulating electrode are spaced from one another along a length of the band (the electrodes spaced along the band, as shown in the annotated Figure 3 below, would include first and second electrodes spaced from one another along a length of the band such that they would stimulate first and second nerves); wherein during the second time frame, the device can maintain or change an activation state of one or more of any of the stimulating electrodes and/or one or more of any of the common electrodes (this capability is possible using the signal generator 24 and switches 26 shown in Figure 2 and described in paragraph [0050]); and wherein one or more of the stimulation current paths and/or a number of stimulation current paths created by the device during the first time frame is configured to change during the second time frame (the “sweeping” of stimulation current described in paragraph [0057] is considered to satisfy the limitation, as the sweeping of the current occurs over a period of time, which could be broken into first and second time frames). However, while Shloznikov discloses that the band is flexible and made of rubber (“the platform 50 is made from a flexible, non-conductive material, such as rubber or mylar, which permits the plurality of electrodes 60 to substantially conform to a surface of the user”, paragraph [0032]), Shloznikov fails to explicitly disclose that the band is configured to, when worn, at least partially encircle a limb of a user or when the band is worn, the first and second stimulating electrode are circumferentially spaced from one another to stimulate the first and second nerves of the user. Rosenbluth teaches a peripheral nerve stimulator that includes an array of electrodes 1500 that “can be integrated into a sleeve” (paragraph [0187]) such that the electrodes are easy to quickly apply and enable patients to use it discretely and comfortably (see paragraph [0185]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Shloznikov such that the electrodes are integrated into a sleeve, as taught by Rosenbluth, in order to make such electrodes easy to quickly apply and enable patients to use it discretely and comfortably.
Regarding claim 216, Shloznikov discloses that the device is configured to change a parameter of a stimulation signal sent to one or more of any of the stimulating electrodes between the first and second time frames to create one or more stimulation channels (see paragraphs [0057]-[0058] and Table A, which shows sweeps 1-3 with changing parameters).
Regarding claim 217, Shloznikov discloses that the parameter of the stimulation signal comprises at least one of a stimulation amplitude, a frequency, a patterned burst stimulation, an interval, a time of day, an individual session or a cumulative on time (“One advantage of the above is that the application of the base wave b, at the different frequencies, namely 4 Hz, 2 Hz and 77 Hz, will have different beneficial effects to the patient.”, paragraph [0058]).
Regarding claim 218, Shloznikov discloses that the device is configured to change one or more parameters of a stimulation signal sent by the first stimulating electrode and/or the second stimulating electrode during the first time frame as compared to the second time frame (see paragraphs [0057]-[0058] and Table A, which shows sweeps 1-3 with changing parameters).
Regarding claim 219, Shloznikov discloses that the device is configured to activate the first common electrode while the second common electrode is deactivated, and wherein the device is configured to activate the second common electrode while the first common electrode is deactivated (the sweep described in paragraphs [0057]-[0058] results in the electrodes on one end of the device being active while the electrodes on the opposite end of the device are inactive).
Claim 214 is rejected under 35 U.S.C. 103 as being unpatentable over Shloznikov (U.S. 2003/0191506, previously cited) in view of Rosenbluth et al. (U.S. 2017/0014625), as applied to claims 200-213 and 215-219 above, and further in view of Wong et al. (U.S. 2019/0134393). Shloznikov in view of Rosenbluth discloses the invention substantially as claimed, but fails to disclose that the first stimulating electrode, the first set of common electrodes, the second stimulating electrode, and the second set of common electrodes comprise dry electrodes. Wong teaches a device 900 for providing transcutaneous electrical nerve stimulation that includes dry electrodes 902/904 (see Figure 8 and “the integrated electrodes 902, 904 can be dry electrodes”, paragraph [0089]), where the use of dry electrodes provides an advantage because they “do not require any adhesive or layer of conductive moisture (such as a gel or spray) to achieve the skin contact sufficient for comfortable delivery of electrical stimulation” and “allow the electrode to be effectively used for relatively long periods of times” (paragraph [0090]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Shloznikov in view of Rosenbluth to utilize dry electrodes, as taught by Wong, in order to allow the electrodes to be effectively used for relatively long periods of time and because they do not require any adhesive or layer of conductive moisture (such as a gel or spray) to achieve the skin contact sufficient for comfortable delivery of electrical stimulation.
Response to Arguments
Applicant’s arguments with respect to claims 200 and 215 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. McBride (U.S. Patent No. 11,724,106) discloses a brace of a limb 10 of a user that includes stimulating electrodes 122/123 and return electrodes 124/125 (see Abstract and Figures 2-4).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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