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 .
Remarks
This action is in response to the remarks filed 04/14/2026.
Claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, see page 8, filed 04/14/2026, with respect to the objection of claim 20 have been fully considered and are persuasive. The objection of claim 20 has been withdrawn.
Applicant’s arguments, see pages 7-8, filed 04/14/2026, with respect to the rejection of claims 4, 7, 10, 11, and 16 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The claims 4, 7, 10, 11, and 16 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see pages 5-7, filed 04/14/2026, with respect to the rejection of claims 1-20 under 35 U.S.C. 103 have been fully considered. Independent claim 1 has been amended to recite “wherein the electrode layer defines a central aperture” and “wherein the control module includes a mode button for concurrently controlling the electrode layer and heating layer”. Applicant argues that Mandel does not disclose the claimed single, continuous layer with a hole or opening formed within it and that Mandel does not disclose a mode button for concurrent control. Examiner respectfully disagrees. The claims do not recite a single, continuous layer with a hole or opening formed within it. The claims simply recite an electrode layer with a central aperture. Mandel discloses an electrode layer with a central aperture as claimed (e.g. Fig. 3: electrodes 233 and 236 shown with an area between them; Par. [0032]; Fig. 3 of Mandel is similar to instant Fig. 5, which shows electrodes 122 with a space between them). Therefore, Mandel is still eligible as prior art.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The new limitation of a mode button for concurrent control is addressed in the office action below. The claims are now rejected as explained in the office action below.
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.
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.
Claims 1-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mandel et al. (US Patent Application Publication 2022/0193409 – of record), hereinafter Mandel, in view of Perez (US Patent Application Publication 2017/0128722 – of record), and further in view of Lee et al. (US Patent Application Publication 2012/0109233 – of record), hereinafter Lee.
Regarding claim 1, Mandel discloses a menstrual pain management device (e.g. Abstract) comprising: a base layer adapted for removable attachment to skin (e.g. Par. [0024]); an electrode layer, the electrode layer covering at least two areas longitudinally located along the base layer, wherein the electrode layer defines a central aperture (e.g. Fig. 3: electrodes 233 and 236 shown with an area between them; Pars. [0031]-[0032]); a heating layer (e.g. Par. [0034]: heating layer 306); an electronic layer, the electronic layer comprising a control module in electric connection with the electrode layer and the heating layer, the control module controlling operation of the electrode layer and the heating layer (e.g. Par. [0025]). However, Mandel fails to specifically disclose the base layer adapted for removable adhesion to skin and the electronic layer covering the other layers, and wherein the control module includes a mode button for concurrently controlling the electrode layer and heating layer.
Perez, in a similar field of endeavor, is directed towards menstrual pain treatment. Perez discloses removable adhesion to skin and the electronic layer covering the other layers (e.g. Par. [0144]: adhesive patch; Par. [0198]: patch is adhesively attached to the skin; Par. [0201]: controller layer 213; Figs. 2A-C: controller layer 213 on top of other layers).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mandel to include the removable adhesion and electronic layer covering the other layers as taught by Perez, because doing so would allow the user to attach the device to their skin to provide the necessary treatment.
However, Mandel in view of Perez fails to specifically disclose wherein the control module includes a mode button for concurrently controlling the electrode layer and heating layer.
Lee, in a similar field of endeavor, is directed towards a portable combined stimulation device for relieving menstrual pain. Lee discloses wherein the control module includes a mode button for concurrently controlling the electrode layer and heating layer (e.g. Par. [0022]: the input comprises a switch for controlling the device which includes both heat and electrical stimulation).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mandel in view of Perez to include the mode button for concurrent control as taught by Lee because doing so would allow easy control of the device.
Regarding claim 2, Mandel further discloses wherein the electrode layer and the heating layer are superposed (e.g. Fig. 3: electrodes 233, 236 on top of heating layer 306). However, Mandel fails to disclose the layers printed on one another. Perez, in a similar field of endeavor, is directed towards menstrual pain treatment. Perez discloses printing the layers (e.g. Par. [0201]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mandel in view of Perez to include printing the layers as taught by Perez because it is a known method of fabricating the layer.
Regarding claim 3, Mandel further discloses the control module further comprises manual controls for controlling operation of the electrode layer and the heating layer, and the electronic layer further provides access to the manual controls of the control module (e.g. Par. [0026]: user input to control the device).
Regarding claim 4, Mandel further discloses wherein the user controls include at least one of the following: an intensity level for the electrode layer (e.g. Par. [0055]), a mode selection for selecting an electric wave pattern for the electrode layer and a frequency of the electric wave pattern (e.g. Par. [0054]; Fig. 8).
Regarding claim 5, Mandel fails to disclose wherein the control module further comprises a rechargeable battery for powering the electronic module, the electrode layer and the heating layer, and an input connector for receiving a connector of an electric cable for recharging the rechargeable battery. Lee, in a similar field of endeavor, is directed towards a portable combined stimulation device for relieving menstrual pain. Lee discloses a rechargeable battery for powering the electronic module, the electrode layer and the heating layer, and an input connector for receiving a connector of an electric cable for recharging the rechargeable battery (e.g. Par. [0014]; Par. [0017]; Par. [0019]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mandel in view of Perez and Lee to include the rechargeable battery as taught by Lee to save natural resources by using a rechargeable battery (e.g. Lee, par. [0014]).
Regarding claim 6, Mandel fails to disclose wherein a periphery of the electronic layer is fused to the base layer to define a water-resistant shell around the electrode layer, the heating layer and the control module. Perez, in a similar field of endeavor, is directed towards menstrual pain treatment. Perez discloses wherein a periphery of the electronic layer is fused to the base layer to define a water-resistant shell (e.g. Par. [0180]: housing is sealed so it is waterproof or water-resistant).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mandel in view of Perez and Lee to include the device being water resistant as taught by Perez to ensure the components are not damaged by water during use.
Regarding claim 7, Mandel fails to disclose wherein the electronic layer covers the controls of the control module. Perez, in a similar field of endeavor, is directed towards menstrual pain treatment. Perez discloses the electronic layer covering the control module (e.g. Par. [0201]: controller layer 213; Figs. 2A-C: controller layer 213 on top of other layers).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mandel in view of Perez and Lee to include the electronic layer covering the control module as taught by Perez, because doing so would allow the user to control the device to provide the necessary treatment.
Regarding claim 8, Mandel further discloses wherein the electrode layer defines a central aperture (e.g. Fig. 3: space shown in between the electrodes 233, 236).
Regarding claim 9, Mandel further discloses wherein the control module further comprises a wireless communication module for communicating with a wireless electronic device (e.g. Pars. [0026]-[0027]).
Regarding claim 10, Mandel fails to disclose wherein the control module wirelessly communicates a recharge level of the rechargeable battery to the wireless electronic device. Perez, in a similar field of endeavor, is directed towards menstrual pain treatment. Perez discloses the control module wirelessly communicates a charge level of the device to the wireless electronic device (e.g. Par. [0040]: wireless communication; Par. [0179]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mandel in view of Perez and Lee to include communicating the charge level as taught by Perez to inform the user when the device needs charging.
Regarding claim 11, Mandel fails to disclose wherein the control module is adapted for controlling the electrode layer to generate a haptic signal indicative of a low recharge level of the rechargeable battery. Perez, in a similar field of endeavor, is directed towards menstrual pain treatment. Perez discloses generating a haptic signal indicating a low charge level of the device (e.g. Par. [0179]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mandel in view of Perez and Lee to include communicating the charge level as taught by Perez to inform the user when the device needs charging.
Regarding claim 12, Mandel further discloses wherein the control module includes a mode button for concurrently controlling the electrode layer and heating layer (e.g. Par. [0054]).
Regarding claim 13, Mandel further discloses wherein the mode button provides a low control for concurrently controlling the electrode layer on low intensity and the heating layer on low intensity (e.g. Par. [0054]).
Regarding claim 14, Mandel further discloses wherein the mode button provides a high control for concurrently controlling the electrode layer on high intensity and the heating layer on high intensity (e.g. Par. [0054]).
Regarding claim 15, Mandel fails to disclose wherein the base layer and the electronic layer are made of a medical grade silicon. Lee, in a similar field of endeavor, is directed towards a portable combined stimulation device for relieving menstrual pain. Lee discloses using silicon to make the base layer and electronic layer (e.g. Par. [0033]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mandel in view of Perez and Lee to include the device being made of silicon as taught by Lee because doing so would result in a device that is safe to use on a user’s skin.
Regarding claim 16, Mandel further discloses wherein the electrode layer comprises a similar design of electric wire in each one of the at least two areas longitudinally located along the base layer (e.g. Par. [0043]).
Regarding claim 17, Mandel further discloses wherein the heating layer defines a belt along the base layer (e.g. Fig. 3: layer 306).
Regarding claim 20, Mandel further discloses wherein the control module further comprises a feedback button for receiving feedback from a user of the menstrual pain management device, the control module adapting the control of the electrode layer and heating layer in response to the feedback received from the user (e.g. Par. [0023]; Par. [0058]).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mandel et al. (US Patent Application Publication 2022/0193409 – of record), hereinafter Mandel, in view of Perez (US Patent Application Publication 2017/0128722 – of record), and further in view of Lee et al. (US Patent Application Publication 2012/0109233 – of record), hereinafter Lee, as applied to claim 1 above, and further in view of Davoudi et al. (US Patent Application Publication 2024/0423539 – of record), hereinafter Davoudi.
Regarding claims 18 and 19, Mandel fails to disclose wherein the electronic layer further comprises a rechargeable battery for powering the electronic module and a wireless charging module for wirelessly recharging the rechargeable battery, wherein the wireless charging module is one of an inductive wireless charging module and a capacitive wireless charging module. Davoudi, in the field of patient monitoring, discloses a rechargeable battery for powering the electronic module and a wireless charging module for wirelessly recharging the rechargeable battery, wherein the wireless charging module is one of an inductive wireless charging module and a capacitive wireless charging module (e.g. Par. [0154]: inductive wireless charging for power source such as a battery).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mandel in view of Perez and Lee to include the wirelessly rechargeable battery as taught by Davoudi to result in a device that is easily chargeable before use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lee et al. (US 2011/0015708, of record) is directed toward an apparatus to relieve menstrual pain.
Poepperling et al. (US 2013/0204169) is directed towards an apparatus with both electrodes and a thermal element to provide pain relief (e.g. par. [0020]).
Fruitman et al. (US 2006/0142816) is directed towards a device that provides both electrical stimulation and thermal therapy for pain relief.
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 SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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