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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first and second four-piece buckles (claim 10) must be shown or the feature(s) canceled from the claim(s). It is noted that elements 233a and 233b do not appear to show a four-piece buckle in any traditional sense, but rather a snap-like element. Clarification is requested. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kolb et al. (Kolb: Pub. No. 2015/0290450).
Regarding claim 1, Kolb discloses pants for repairing pelvic floor muscles (par. 0005), comprising: a wearing pants body (non-conductive substrate 5 of Fig. 1 or any similar structure shown in Figs. 1, 3, 5, 9, etc.), and an electrical stimulation member 4 (or related electrode structure of any of the disclosed embodiments) disposed on the wearing pants body (see at least Fig. 1), wherein: the electrical stimulation member is disposed on a crotch position of the wearing pants body (see at least Fig. 2), the electrical stimulation member comprises a first flexible electrode 401 (or like conductive regions of the various embodiments shown) and a second flexible electrode 402 (where the electrodes of various embodiments may comprise a deformable conductive polymer permitting local deformation and conformity with the user’s anatomy; par. 0036), and the first flexible electrode and the second flexible electrode respectively correspond to front and rear sides of the pelvic floor muscles (Figs. 2 and 4; pars. 0032 and 0033) of a user to apply electrical stimulation to the pelvic floor muscles (TENs stimulation par. 0002).
Regarding claims 2 and 3, see at least Fig. 1.
Regarding claim 4, note Fig. 17 which shows conductive electrodes 4 including portions that extend partially into a rear section and partially into a front section depending on how one defines the front and rear section.
Regarding claim 5, Kolb discloses a “stay away” section corresponding to the clitoris and anus of a user (par. 0032; egress 6, Fig. 1 and like portions in various embodiments)
Regarding claim 6, see par. 0039.
Claim Rejections - 35 USC § 102/103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kolb ‘450.
Regarding claim 7, Kolb’s use of adhesives for connecting the electrodes to the wearable pants body in par. 0039 is considered to require a glue, as the terms are typically interchangeable. In any event, the courts have long recognized that the selection of a known material (e.g., glue) based on its intended purpose (e.g., to adhere elements together) supports a prima facie obviousness determination (MPEP 2144.07). The applicant gives no criticality to the use of a glue other than to provide a means of attachment. To use a glue as an adhesive would have therefore been considered a matter of obvious design by those of ordinary skill in the art.
Claim Rejections - 35 USC § 103
Claim(s) 8-12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kolb ‘450.
Regarding claim 8, while Kolb does not explicitly refer to the recited first and second annular connecting members, Kolb does teach that the electrodes may be temporarily affixed to an underlying absorbent pad or undergarment, including the use of adhesives, tabs and hook and loop fasteners (par. 0039). The applicant discloses that said annular members may include adhesives (par. 0036). The exact shape of the adhesive or other connecting member would have been considered an obvious matter of mechanical expediency. Any shape allowing secure attachment of the electrodes to the undergarment/pants would have been suitable to the invention. The courts have long recognized that changes in shape, absent any evidence that the particular shape was of significance, to be obvious (see MPEP 2144.04, IV, B).
Regarding claim 9, Kolb discloses a controller disposed on the wearer’s body (wearable control unit concealed against or under the user’s clothing, par.0008; with disposal on the pants itself –an article of the user’s clothing—a matter of obvious design where rearrangement of parts, absent evidence of criticality, has been deemed obvious by the courts, MPEP 2144.04, VI, C), the controller is configured to produce stimulation on the pelvic floor muscles by the first flexible electrode and the second flexible electrode (par. 0004), the electrical stimulation member further comprises a first electrical connecting member and a second electrical connecting member (wires/connectors; par. 0041), the first electrical connecting member and the second electrical connecting member are connected to the controller (par. 0041), the first flexible electrode is detachably connected to the first electrical connecting member, and the second flexible electrode is detachably connected to the second electrical connecting member (electrodes may be temporarily affixed and connected to the connectors through one or more connectors such as pins and/or snaps (pars. 0039 and 0041)), where those of ordinary skill in the art would understand connections including snaps and/or pins to be detachable, and in the least, obvious in order to allow the electrodes to be replaced as needed, while permitting the control unit to be reused (see Figs. 9 and 14).
Regarding the use of microcurrents, both Kolb and the applicant’s invention are designed to apply electrical stimulation therapy to the pelvic floor in the treatment of incontinence. One would therefore expect similar currents to be applied with routine experimentation dictating the most optimal level for the situation at hand. It is further noted that TENs devices typically operate at such levels, and that the term “microcurrents” is not defined or restricted by the applicant. Those of ordinary skill in the art would have considered the application of microcurrents to be obvious.
Regarding claim 10, while Kolb does not discuss the use of first and second four-piece buckles, those of ordinary skill would have considered the use of any known suitable connecting structure to be a matter of obvious design provided the arrangement permitted adequate connection and release of system components when needed, and user comfort for extended wear.
Regarding claims 11 and 12, see par. 0041 and Fig. 14.
Regarding claim 14, Kolb teaches that the electrodes may include a conductive film (par. 0042). It should be noted that the manner of manufacturing the coating layer (in this case, printing), is considered to represent a product-by-process limitation where the patentability does not rely upon the process of making, but relies on the product itself (see MPEP 2113). Additionally, Kolb further discloses that the conductive elements of the connecting members may be wires or other conductive media including carbon or silver films (par. 0041). The use of conductive silicone would have been considered a matter of obvious design based on its suitability to provide the necessary conduction. Conductive silicones are old and well-known as they are biocompatible, flexible and of course, conductive –all features that would be required in the Kolb device—and thus the use of such materials would have been considered a matter of obvious design by those of ordinary skill in the art.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kolb ‘450 in view of Panting (Pub. No. 20120016446).
Regarding claim 13, while the use of silver-fiber conductive cloth is not explicitly referred to by Kolb, Kolb does teach that conductive elements may include silver films (par. 0041). Clearly silver is widely recognized for its suitability as a conductor of electricity, as well as for its anti-bacterial and biocompatible properties. Panting, for example, discloses underwear comprising electrodes constructed using silver-impregnated nylon suitable for transcutaneous stimulation (pars. 0049, 0062 and 0063). To therefore employ the same materials in the design of the Kolb pants to reap the same benefits would have been considered a matter of obvious design by those of ordinary skill in the art.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kolb in view of Panting ‘446 and Miller et al. (Miller: Pub. No. 2023/0050850).
Regarding claim 15, Kolb does not discuss the use of first and second electrodes forming a plurality of transverse grooves separately disposed along a front and rear direction. As discussed above, Panting suggests that the electrodes may be made using conductive fabrics. Miller discloses a women’s undergarment employing moisture absorbent materials with raised parallel cords of fabric (e.g., pique, where grooves extend between raised cords) extending in a transverse direction (see 204, Fig. 2). It is taught that such an arrangement improves the channeling or wicking of moisture away from the body, thus improving user comfort and improving sanitary conditions (pars. 0003 and 0031; see also Kolb par. 0064 which teaches that excessive moisture may adversely affect the skin/electrode interface). Artisans of ordinary skill in the art desiring to improve user comfort and sanitation, as well as the electrical performance of the stimulator, would have therefore considered the use of electrodes made with conductive fabrics including a plurality of transverse grooves to be obvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Riha-Scott ‘437 discloses the use of pique mesh underwear for its absorbent and anti-bacterial properties. Kirsch ‘883 discloses a wearable TENS device for treating pelvic floor disorders.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached at 571 270 5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
February 11, 2026