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 Amendment
The amendment filed 15 August 2025 has been entered. Claims 1 and 5-6 are currently amended. Claim 3 is canceled. Claims 1, 4-6, and 8-10 are pending in the application. Applicant’s amendments to claim 1 have overcome the objection previously set forth in the Non-Final Office Action mailed 18 April 2025.
Response to Arguments
Applicant's arguments filed 15 August 2025 have been fully considered but they are not persuasive.
As best understood, Applicant argues that Crowe does not teach sequential switching of a common electrode (that is, an electrode set to a first polarity while the remaining plurality of electrodes are each set as a second polarity), and because Samejima’s method of detecting poor electrical connection also does not teach sequential switching of a common electrode, the combination would not have been obvious without improper hindsight. However, this argument is not found to be persuasive, because neither Crowe or Samejima is relied upon to teach sequential switching of a common electrode. One of ordinary skill in the art would have been motivated to incorporate Crowe’s arrangement into Minogue’s device of a single electrode set to a first polarity with the remaining plurality of electrodes set as a second polarity because Crowe teaches that such an arrangement concentrates stimulation intensity at the first polarity, and the skilled artisan would have also been motivated to incorporate Samejima’s current-detection circuit because Samejima teaches that the circuit makes it possible to detect whether the electrodes are properly worn by the user, thereby arriving at the claimed invention, as broadly as it is currently recited.
Additionally, in response to Applicant's argument that the references (namely Crowe) fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., in the case that one of the electrodes set as the second polarity is not attached to a user, switching the polarity of the electrodes in order to identify which of the electrodes is not attached; or implicitly, sequentially setting every one of the electrodes to the first polarity during a testing sequence in order to confirm that all the electrodes are in proper contact with the user) are not recited in the rejected claim(s). 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).
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 1, 4-6, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Minogue et al. (US PGPub No. 2002/0058972), hereinafter Minogue, in view of Samejima et al. (WO 2018/092451), hereinafter Samejima, and Torimitsu (US PGPub No. 2017/0296079), and further in view of Crowe et al. (US PGPub No. 2003/0093133), hereinafter Crowe.
Regarding claim 1, Minogue teaches an electrical stimulator that applies electrical stimulation to a user (par. 0004: “an electrotherapeutic device and method for stimulating abdominal muscles of a subject”), the electrical stimulator comprising:
an electrode group that has three or more electrodes that are disposed so as to come into contact with the user (Figs. 10-12 and par. 0132: “a central electrode 26 and a pair of side electrodes 27 adjacent the abdomen 5”);
signal generating circuitry that gives energy to the electrode group (par. 0132: “a central electrode 26 and a pair of side electrodes 27 adjacent the abdomen 5 for applying one or more pulsed signals generated by a signal generating means, namely, a signal generator 28”),
under a condition that one or more electrodes of the electrode group are each set as a first polarity and that one or more other electrodes are each set as a second polarity (Fig. 13 and par. 0145: “the respective left and right side electrodes 27a and 27b which are also designated with the reference letters L and R, respectively, are independently connected to the pulse generator 28, and independently apply respective pulsed signals l1 and l2 to the subject which are generated by the pulse generator 28. The central electrodes 26 which is designated in the reference letter U, acts as a common return electrode”),
while performing switching among at least either the electrodes each of which is set as the first polarity or the electrodes each of which is set as the second polarity (par. 0081: “the at last one pulsed signal is applied sequentially to each of the selected pairs of electrodes;” examiner interprets applying a pulsed signal sequentially to different pairs of electrodes as switching among the electrodes set as the first polarity or the second polarity).
Minogue does not teach circuitry that detects an electrical connection defect by detecting whether electrical stimulation has been applied to the user when energy is given to the electrode group. However, in an analogous art, Samejima teaches an electrotherapy stimulating device with circuitry that detects whether a plurality of electrodes are in contact with the user by detecting whether electrical stimulation has been applied to the user when energy is given to the electrode group (see machine translation page 7, par. 0032: “The current detection circuit detects the value of the current flowing between the pair of pads 270 and inputs a signal indicating the detected value to the processor 210” and page 8, par. 0032: “Further, the processor 210 uses the current value input from the current detection circuit to determine whether the pad 270 is attached to the user (attached) or whether the pad 270 is not attached to the user (peeled off). Specifically, processor 210 determines that pad 270 is worn by the user when the current value is greater than or equal to a predetermined value, and determines that pad 270 is worn by the user when the current value is less than the predetermined value. It is determined that the device is not attached to the device. This is because if at least one of the pair of pads 270 is not properly worn by the user, the current loop that is output from one pad 270, passes through the human body, and returns to the other pad 270 will not be established. It uses the principle that a current that exceeds a certain value will not flow;” examiner interprets current passing through the human body as application of electrical stimulation to the user).
It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Minogue by incorporating the current detection circuit and processor of Samejima as a means for detecting connection defects, since the current flow necessary for electrotherapy will not be established unless the electrodes are properly worn by the user, as taught by Samejima.
Minogue also does not teach wherein each electrode comprises a fiber-based substrate coated with a layer of poly-3,4- ethylenedioxythiophene (PEDOT) polymer doped with iron salt derived from p-toluenesulfonic acid. However, in an analogous art, Torimitsu teaches a bioelectrode comprising a fiber-based substrate coated with a layer of poly-3,4- ethylenedioxythiophene (PEDOT) polymer doped with iron salt derived from p-toluenesulfonic acid (par. 0012: “a base selected from the group consisting of a silk fiber, a fiber containing sericin or fibroin, and a fiber coated or soaked with sericin or fibroin; and poly(3,4-ethylene-dioxythiophene)-p-toluenesulfonate (PEDOT-pTS) applied to the base;” see also description in par. 0078 of EDOT polymerization using p-toluene sulfonic acid iron (III) in a butanol solution).
Torimitsu further teaches that the disclosed bioelectrode has the advantages of low electrical resistance, comfort, durability, water resistance, and flexibility (par. 0039: “The electrically conductive material of the present invention, which has a low electrical resistance value, is pleasant to the touch, highly durable and highly water-resistant, and also has flexibility, may be suitably used as a bioelectrode”) and that PEDOT-pTS has higher conductivity than PEDOT-PSS (par. 0028). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the stimulator of Minogue by using the bioelectrodes taught by Torimitsu, including a base made of fiber and PEDOT-pTS for the electroconductive polymer, in order to benefit from the advantages of low electrical resistance, comfort, durability, water resistance, flexibility, and higher conductivity, as taught by Torimitsu.
Minogue further teaches switching among electrodes each of which is set as the first polarity in predetermined order (par. 0157: “The signals generated by the signal generator 28 may be applied to the first and second central electrodes 78 and 79 and the side electrodes 27 in any or all of the six electrode pairs, and may be applied sequentially, simultaneously, or partly simultaneously and sequentially to the electrode pairs in any order”) but does not explicitly teach wherein the signal generator is configured to give energy to the electrode group under a condition that one electrode of the electrode group is set as the first polarity and that the remaining plurality of electrodes are each set as the second polarity.
However, in the same field of endeavor, Crowe teaches setting one electrode of an electrode group as a first polarity and the remaining plurality of electrodes as a second polarity in order to stimulate the region of the electrode set to the first polarity while not stimulating the region of the plurality of electrodes set to the second polarity (par. 0021: “The control circuit may be operable such that during at least one time period the pulse is applied simultaneously across a plurality of outputs at one polarity and one other output at the opposite polarity such that a number of electrodes act as anodes and one electrode as a common cathode, or vice versa, whereby the intensity of the current in the region of the electrodes connected to said plurality of outputs is insufficient to stimulate that region whereas the intensity of the current in the region of the electrode connected to said one output is sufficient to stimulate the latter region”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by incorporating the control circuit configuration of Crowe in order to stimulate the region of the electrode set to the first polarity while not stimulating the region of the plurality of electrodes set to the second polarity, as taught by Crowe.
The combined reference does not explicitly teach wherein, if electrical stimulation is not applied to the user when energy is given to the electrode group, the connection-defect detection means is configured to detect that there is an electrical connection defect in the electrode set as the first polarity. However, in the control circuit configuration taught by Crowe with only one electrode of the group set as the first polarity, a detectable current-based connection defect signal (as taught by Samejima) will only occur if the electrode set as the first polarity has an electrical connection defect; in any other case, electrical stimulation will still be applied to the user because the current loop through the user’s body is established as long as the electrode set as the first polarity and at least one other electrode set as the second polarity are connected to the user. The combined reference is therefore considered to also read on this limitation.
Regarding claim 4, the combination teaches the device of claim 1 as described previously. Minogue further teaches wherein the electrode group has at least a first electrode disposed correspondingly to rectus abdominus muscles (Figs. 10-12: central electrode 26), a second electrode disposed correspondingly to right-hand oblique abdominal muscles, and a third electrode disposed correspondingly to left-hand oblique abdominal muscles (Figs. 10-12: side electrodes 27).
Regarding claim 5, the combination teaches the device of claim 1 as described previously. Minogue teaches wherein the electrode group has four electrodes, with the first and second electrodes disposed correspondingly to rectus abdominus muscles (Fig. 21: central electrodes 78, 79), and the third electrode disposed correspondingly to right-hand oblique abdominal muscles and the fourth electrode disposed correspondingly to left-hand oblique abdominal muscles (Figs. 21, 25: side electrodes 27a, 27b), but does not explicitly teach wherein the first electrode is disposed correspondingly to right rectus abdominis muscles and the second electrode is disposed correspondingly to left rectus abdominis muscles.
However, Minogue teaches that it is known in the prior art to stimulate the right and left rectus abdominis muscles separately (Fig. 1 and par. 0131: “The electrode pairs 20a and 20b and 21a and 21b stimulate the rectus abdominis muscles 15”). In light of this teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by disposing the central electrodes to be attached to a user’s right and left rectus abdominis muscles, respectively, since it was known in the prior art to target the right and left abdominis muscles separately, and it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Minogue also does not explicitly teach wherein the signal generator is configured to perform switching among the electrodes set as the first polarity so that the first electrode and the second electrode do not consecutively become the first polarity, wherein the switching enables individual defect detection of each electrode set as the first polarity. However, Minogue teaches that the signal generator may be configured to perform switching among the electrodes in any order during treatment (par. 0167: “It will of course be appreciated that any or all of the subcutaneous current paths which may be selected by appropriately selecting the electrodes in appropriate selected pairs may be selected in any order, and the order and selection may vary during a treatment regime by suitably programming the microprocessor in the signal generator”). In light of this teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select an order for switching electrodes so that the first electrode and the second electrode do not consecutively become the first polarity, because Minogue teaches that the signal generator as disclosed is capable of performing switching among the electrodes in any order. Additionally, as described previously in the rejection of claim 1, a detectable current-based connection defect signal (as taught by Samejima) will only occur if the electrode set as the first polarity has an electrical connection defect. The combination is therefore considered to read on the limitation of wherein the switching enables individual defect detection of each electrode set as the first polarity.
Regarding claim 6, the combination teaches the device of claim 5 as described previously. Minogue does not explicitly teach wherein the signal generator is configured to perform switching among the electrodes each of which is set as the first polarity in order of the first electrode, the fourth electrode, the second electrode, and the third electrode. However, Minogue teaches that pairs of electrodes may be selected in any order (par. 0167: “It will of course be appreciated that any or all of the subcutaneous current paths which may be selected by appropriately selecting the electrodes in appropriate selected pairs may be selected in any order, and the order and selection may vary during a treatment regime by suitably programming the microprocessor in the signal generator”). In light of this teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the signal generator of the combined reference to perform switching among the electrodes in any order as desired for the specific treatment regime, as taught by Minogue. The combination also reads on the limitation of wherein the switching enables individual defect detection of each electrode set as the first polarity, for the same reasons set forth in the rejections of claims 1 and 5.
Regarding claim 8, the combination teaches the device of claim 1 as described previously. Minogue further teaches wherein the signal generator is configured to give energy to the electrode group under a condition that one or more electrodes of the electrode group are each set as the first polarity and that one or more other electrodes are each set as the second polarity (Fig. 13 and par. 0145: “the respective left and right side electrodes 27a and 27b which are also designated with the reference letters L and R, respectively, are independently connected to the pulse generator 28, and independently apply respective pulsed signals l1 and l2 to the subject which are generated by the pulse generator 28. The central electrodes 26 which is designated in the reference letter U, acts as a common return electrode”), while selectively performing switching among the electrodes each of which is set as the first polarity and the second polarity in accordance with a muscle action pattern (par. 0093: “a selecting means for selectively selecting the electrodes in electrode pairs and for selectively applying the at least one pulsed signal to the selected electrode pairs for selective stimulation of the muscles of the muscle group;” examiner interprets selective stimulation of the muscles of a muscle group as stimulation in accordance with a muscle action pattern).
Regarding claims 9-10, the combination teaches the device of claim 8 as described previously. Minogue further teaches that the disclosed device can be adapted to stimulate other muscle groups, including arm and leg muscles (par. 0166: “While the device has been described for stimulating abdominal muscles, it will be apparent to those skilled in the art that the device by suitably adapting the attachment means may be used for stimulating other muscle groups of a subject, for example, back muscles, leg muscles, arm muscles, or indeed any other muscle group”) and that, under a condition that one or more electrodes among the electrode group are each set as the first polarity and that one or more remaining electrodes are each set as the second polarity (Fig. 13 and par. 0145: “the respective left and right side electrodes 27a and 27b which are also designated with the reference letters L and R, respectively, are independently connected to the pulse generator 28, and independently apply respective pulsed signals l1 and l2 to the subject which are generated by the pulse generator 28. The central electrodes 26 which is designated in the reference letter U, acts as a common return electrode”), the signal generator is configured to selectively perform switching among the electrodes each of which is set as the first polarity and as the second polarity in accordance with a muscle action pattern (par. 0093: “a selecting means for selectively selecting the electrodes in electrode pairs and for selectively applying the at least one pulsed signal to the selected electrode pairs for selective stimulation of the muscles of the muscle group”).
The combination does not explicitly teach wherein the electrode group has at least a first electrode disposed correspondingly to an antebrachial musculus extensor carpi radialis brevis, a second electrode disposed correspondingly to an antebrachial musculus flexor carpi radialis, a third electrode correspondingly to a biceps brachii muscle, and a fourth electrode disposed correspondingly to a triceps brachii muscle; nor does the combination explicitly teach having a first electrode disposed correspondingly to a biceps femoris muscle, a second electrode disposed correspondingly to a quadriceps femoris muscle, a third electrode disposed correspondingly to a triceps surae muscle, and a fourth electrode disposed correspondingly to a tibialis anterior muscle. However, in light of Minogue’s teaching that the disclosed device may be suitably adapted for stimulation of arm muscle groups or leg muscle groups, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the device so that the electrodes are disposed correspondingly to the major muscles of the arms and legs as claimed, because there were a finite number of muscles in the arms and legs, and one of ordinary skill in the art could have configured the device to stimulate any combination of muscles in the arms or legs with predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ferree et al. (US PGPub No. 2014/0296935) teaches an electrode-skin contact detector that is capable of detecting electrode peeling by monitoring whether electrode-skin impedance increases due to a decrease in stimulation current.
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 DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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, LINDA C DVORAK can be reached at 571-272-4764. 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.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794