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
Claims 1-3, 11-18 are canceled. Claims 4-10 are amended and pending in this action.
Drawings
Applicant’s arguments, filed 11/19/2025, with respect to the Drawing objections have been fully considered and are persuasive. The Drawing objection of 05/19/2025 has been withdrawn.
Claim Objections
Applicant’s arguments, filed 11/19/2025, with respect to the claim 9 objection have been fully considered and are persuasive. The claim 9 objection of 05/19/2025 has been withdrawn.
35 USC § 101
Applicant’s arguments, filed 11/19/2025, with respect to the 35 USC § 101 rejections of 3 and 6-7 have been fully considered and are persuasive. The 35 USC § 101 rejections of 3 and 6-7 of 05/19/2025 has been withdrawn.
35 USC § 112
Applicant’s arguments, filed 11/19/2025, with respect to the 35 USC § 112(a) rejections of 12-13 have been fully considered and are persuasive. The 35 USC § 112(a) rejections of claims 12-13 of 05/19/2025 has been withdrawn. However, new rejections for claims 6-7 and 9 under 35 USC § 112(a) are detailed in the rejection below. Specifically, claim 9 requires pulse widths of approximately 270 s, however no support in the specification was found.
The 35 USC § 112(b) rejections of claim 8 of 05/19/2025 has also been withdrawn.
35 USC § 102/103
Applicant's arguments filed 11/19/2025 have been fully considered but they are not persuasive.
Applicant’s arguments rely on language solely recited in preamble recitations in claim(s) 4-10. When reading the preamble in the context of the entire claim, the recitation “An apparatus for treatment of nocturnal enuresis…” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
In response to applicant's argument that the combination of White (US 9486627 B1 – hereinafter White) are Kaplan (US 20170021157 A1 – hereinafter Kaplan) are not obvious to treat nocturnal enuresis, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Specifically, claims 4-10 are apparatus claims; it is then reminded that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim, see MPEP 2114. Any technical difference in both White and Kaplan to treating nocturnal enuresis does not differentiate from the structural elements required by the claims; instead, if the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, it is maintained that the references as taught by White and Kaplan sufficiently teaches the structural elements of claims 6-7, and would therefore be capable of treating nocturnal enuresis in its use. In the instant case, both White and Kaplan pertain to the neural stimulation systems comprising electrodes placed on the leg/foot, where Kaplan is further relied on to teach the known technique of placing electrodes on a foot pad location as shown by figures 3A and 9.
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And therefore, 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 electrode placements of White, with the electrode placements as taught by Kaplan to stimulate the foot muscles and nerves.
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Specification
The disclosure is objected to because of the following informalities:
Paragraph 0026 recites, “approximately270 us”, which should be spaced to read, “approximately 270 us”. Appropriate correction is required.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors in which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-7 and 9 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
There is no specific support found for the claim 6 limitation, “…and wherein the foot pad location is not located on or approximately on an arch of a foot of a patient”. Paragraph 0050 describes the foot pad location 149 for the electrode’s placement, and figure 2 of the Applicant’s drawings shows the foot pad location 149 to be located on the arch of a foot, and would substantially correspond to the electrode foot pad location of Kaplan figure 9, as stated in the previous rejection. Without specific support or mention in the specification to the electrode pad locations not located on or approximately on an arch of a foot of a patient, claim 6 is therefore rejected under 35 U.S.C. 112(a) as being directed to new matter. Claim 7 is further rejected for its dependency to claim 6.
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Claim 9 recites, “…with a width of approximately 270 s…”, however no specific support could be found in the specification for pulse widths of approximately 270 s. Paragrphs 0026, 0035 and 0054 recite pulse widths of approximately 270 us, but does not contain support for 270 s, or 270 seconds (as interpreted by the Examiner). Without specific support or mention in the specification to pulse widths of approximately 270 s (seconds), claim 9 is therefore rejected under 35 U.S.C. 112(a) as being directed to new matter.
Claim Interpretation
It was unclear if claim 9 was intended to require pulse widths of approximately 270 s (seconds), since this would equate to 4:30 minutes of continuous stimulation delivered to nerves, which would be considered exceptionally long and could cause tissue damage, or the “u” in 270 us was mistakenly omitted. Therefore, it was interpreted that claim 9 required pulse widths of approximately 270 us.
The term(s) “can” and “configured to” in the claim(s) may be interpreted as intended use. Intended use/functional language does not require that references teach or disclose the intended use of an element. 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.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 4-5, 8 and 10 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by White (US 9486627 B1 – hereinafter White) (cited previously).
Re. claim 4, White teaches an apparatus for treatment of nocturnal enuresis, the apparatus (figure 1),
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comprising:
a control unit (figure 1, control unit 10),
a controller, wherein the controller is in electrical or mechanical communication with the control unit, a band, a plurality of electrical leads (figure 3, setup remote 30; column 4, lines 23-26: “FIG. 3 shows a preferred embodiment of the setup remote 30. It is an electronic device that functions as a remote control to test or change operating values for the control unit 10”),
and a plurality of electrode pads (figure 1, electrode pads 11-14):
wherein the control unit generates a plurality of electrical impulses for transcutaneous electrical nerve stimulation (TENS) (column 1, lines 18-20: “The present invention electrically stimulates the nerve…”; column 6, lines 12-16: “The setup remote 30 functions as a remote control that enables a clinician, or other person, to adjust the values that set the pulse width, frequency, and ramp-up and ramp-down variables of the stimulus given to the user, to meet the individual requirements of the patient.”)
and wherein the plurality of electrical leads comprises two electrical leads, and wherein the two electrical leads are in electrical communication with the control unit and with the plurality of electrode pads (figure 1 shows leads connected to electrode pads 11-14 and control unit 10),
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such that the plurality of electrical impulses may be transmitted from the control unit through the electrical leads to the plurality of electrode pads, where the plurality of electrical impulses can penetrate a plurality of skin of a patient (column 2, lines 61-62: “Connected to the control unit are electrodes that provide electrical stimulation to the user. The electrodes are adhered to the skin over the nerve and muscle causing the disability”).
Re. claim 5, White further teaches wherein the plurality of electrode pads comprises two electrode pads, and wherein the two electrode pads are configured to be used in two pad placement locations (figure 1 shows at least two electrode pads 11-14 placed in different locations of the leg).
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Re. claim 8, White further teaches wherein the control unit omits a control for waveform of the plurality of electrical impulses (figure 3 setup remote 30 controls stimulation parameters as opposed to the control unit 10 itself, disclosed in column 6, lines 12-16: “The setup remote 30 functions as a remote control that enables a clinician, or other person, to adjust the values that set the pulse width, frequency, and ramp-up and ramp-down variables of the stimulus given to the user, to meet the individual requirements of the patient.”),
and wherein the control unit is preprogrammed with a set of waveform settings comprising pulse rate (column 18, lines 43-45: “Stimulation is ramped up at a rate predetermined by the clinician and entered into the microcontroller from the setup remote”), frequency, pulse width, normal mode, and a therapy-duration time (figure 3 setup remote 30 controls stimulation parameters as opposed to the control unit 10 itself, disclosed in column 6, lines 12-16: “The setup remote 30 functions as a remote control that enables a clinician, or other person, to adjust the values that set the pulse width, frequency, and ramp-up and ramp-down variables of the stimulus given to the user, to meet the individual requirements of the patient”; normal mode in column 11, lines 28-29: “The operating values are default values unless changed by the clinician…”):
and wherein at least some of the set of waveform settings can not be adjusted (control unit 10, which controls stimulation parameters, allows a clinician, or otherwise user, to adjust settings or refrain from adjusting at least some of the waveform settings if chosen to do so).
Re. claim 10, White further teaches wherein the control unit further comprises an activation control (column 2, lines 65-67: “A small wireless remote control unit, called the pocket remote, can be used by the patient to turn the control unit on and off, or to switch the control unit to standby when the user stops walking for a time”) and an intensity control (column 6, lines 12-16: “The setup remote 30 functions as a remote control that enables a clinician, or other person, to adjust the values that set the pulse width, frequency, and ramp-up and ramp-down variables of the stimulus given to the user, to meet the individual requirements of the patient”; column 12, lines 26-27: As the pulse width increases, the stimulus intensity increases…).
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.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over White (US 9486627 B1 – hereinafter White) in view of Kaplan (US 20170021157 A1 – hereinafter Kaplan).
Re. claims 6-7, White teaches the claimed invention as stated above except wherein the plurality of electrode pads are configured to be used in an ankle (posterior tibial) pad location, and wherein the ankle (posterior tibial) pad location comprises a location for one or more of the plurality of electrode pads on an ankle and a location for one or more of the plurality of electrode pads on a foot, referred to as a foot pad location and wherein the foot pad location is not located on or approximatelv on an arch of a foot of a patient, and wherein the ankle (posterior tibial) pad location, to create an indirect distal neural loop, means the plurality of electrode pads have a plurality of pad placement locations on a bottom of a foot of a patient, and over a posterior portion of a medial malleolus on the ankle that is ipsilateral thereto.
Kaplan teaches a neuromuscular electrical stimulation (NMES) to muscles of foot (abstract) which teaches the stimulation device in figure 4 using in figure 6A the known technique of placing stimulation electrode pads placed on the ankle,
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and electrode pads on the bottom foot in figure 3A, wherein the foot pad location is not located on or approximately on an arch of a foot of a patient (figure 3A shows electrodes 36 placed on a ball of foot 33 and heel pad 35).
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Kaplan further teaches electrode pads on the bottom foot in other locations as per figure 9.
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Kaplan further teaches in paragraph 0060 – “…the electrodes are placed at the level of the main ankle bones called the medial malleolus and the lateral malleolus. For both electrodes, the connection site would be just below the malleolus. For other indications, the electrodes are located on the sole of the foot.”
Since Kaplan and White both teach neural stimulation systems using electrode pads, 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 stimulation system, specifically the electrode pad placements of White to incorporate the electrode pad placements of the foot pad and ankle as taught by Kaplan as shown above, since such modification would predictably result to stimulate the foot muscles and nerves “to expedite wound healing; to reduce neuropathic pain of the foot and ankle, chronic musculoskeletal pain of the ankle and foot, and acute post-operative foot and ankle pain; and to prevent muscular atrophy of the foot muscles” (Kaplan abstract).
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Furthermore, it is reminded that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), and a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim (see MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over White (US 9486627 B1 – hereinafter White) in view of John (US 20190143097 A1 – hereinafter John) (cited previously).
Re. claim 9, White teaches the claimed invention as stated above except a set of waveform settings comprise a pulse rate of approximately 10 Hz, normal mode, with a waveform pulse that is rectangular with a width of approximately 270 us, a therapy-duration time set to 15 min, and a pulse intensity that is determined either programmatically, or by a medical provider based on a tolerance threshold of a patient, or by the patient and/or a caregiver.
John teaches similar transcutaneous stimulation electrodes to treat nerves in a leg in paragraph 0084 – “FIGS. 5A, 5B, and 5C show embodiments of TENS electrodes used to provide stimulation of nerve targets such as those in a limb (e.g. a leg for SAFN stimulation)”, and teaches square wave stimulation with pulse widths of approximately 270 usec in paragraph 0102 - “stimulation provided transcutaneously (or otherwise) may occur under control of the stimulation/sensing module 76 using a waveform of 200 uSec (0.2 msec) pulse width. This may range for example, from approximately 20 uSec to 100 msec [200,000 usec]. The pulses may be square waves or bipolar and may modulate frequencies of 1 kHz to 50 kHz or 100 kHz” (John paragraph 0102). John further teaches pulse rates approximately 10 Hz (John paragraph 0052 – “…parameters in the ranges of approximately 1-30 Hz (e.g. for SAFN or TN stimulation)…”) and stimulation durations of approximately 30, 60, 90, and 120 minutes (John paragraph 0105). Finally, John discloses in paragraphs 0042-0044 a screening process step 12 in figure 1A is used for determining transcutaneous stimulation treatment parameters (including stimulation amplitude) by step 13 of figure 1B based on patient response to determine what treatment protocols may be suitable for a patient.
Since White and John both teach transcutaneous stimulation systems for limbs, 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 stimulation system of White to incorporate the control unit stimulation parameters as taught by John since such modification would predictably result in improving nerve recruitment (John abstract, paragraph 0004).
Furthermore, it is reminded that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), and a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim (see MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796