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 11/11/2025 has been entered. Amendments to claim 1 and cancellation of claims 28 and 29 is acknowledged. Claims 1-3, 5, 8-12, 21-22, and 24-27, and 30 remain pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5, 8-12, 21-22, 24-27, and 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The term “ergonomic” in claim 1 is a relative term which renders the claim indefinite. The term “ergonomic” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While applicant’s specification para [0220] recites “embodiment of Figure 15a-d is an ergonomic design”, it is not clear from Figure 15a-d what feature renders the disclosed handle ergonomic.
Claims 2-3, 5, 8-12, 21-22, 24-27, and 30 are rejected due to dependency.
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.
Claim(s) 1-3, 5, 1-11, 21, 26, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (CN 212880075 U) in view of Jayol (US 20190262591 A1) in further view of Hong et al. (US 20150094704 A1), hereinafter Hong.
Regarding claim 1, Liu discloses pelvic floor rehabilitation device (abstract: “non-intrusive pelvic floor rehabilitation therapy head”) comprising: a handle for holding and manipulating the pelvic floor rehabilitation device during operation (page 3 para 4: “the head is connected with the base is provided with an elastic piece, so that when using the head in the body can automatically adjust the fitness in a certain angle range.”); and a shaft extending from the handle (Page 2 para 6: “comprising a head capable of being placed in the body when using”) , wherein at least part of the shaft dilates based on input from the controller (Page 2 para 6: “the head is provided with an air bag capable of inflating and deflating; the rehabilitation training of pelvic floor muscle is realized by repeatedly inflating and deflating the air bag.”, page 4 para 1: “can automatically inflating and deflating the air bag 6, realizing non-linear following training.”); and at least one sensor for collecting data during operation of the pelvic floor rehabilitation device (Page 2 para 8 : “a pressure sensor”); and a temperature adjusting system comprising at least one temperature adjusting element disposed on the shaft and operable to alter a temperature in a vagina (Page 3 para 2: “temperature control treatment module capable of detecting and adjusting the temperature; the temperature control treatment module comprises a temperature detecting device and a temperature adjusting device”), wherein the at least one temperature adjusting element provides heating for muscle relaxation and increasing blood flow and cooling for reducing inflammation and pain (Page 4 para 6: “repeatedly shrinking the pelvic floor muscle; in the relaxed recovery training, it will synchronously change with the temperature… temperature adjusting device can be set as circulating cooling water for cooling, heating structure for heating” wherein the temperature adjustment is used for therapy).
Liu fails to disclose herein the handle has an ergonomic design to allow a user to hold the handle and manipulate the device during use, wherein the handle includes at least one input control button engageable by the user during operation of the device, a controller to receive instructions and to control operation of the pelvic floor rehabilitation device, wherein the controller is communicatively coupled to a computing device which transmits preprogrammed instructions for operation of the pelvic floor rehabilitation device, and wherein the controller includes: a plurality of input controls engageable by a user and communicatively coupled to the controller to control the pelvic floor rehabilitation device during operation.
Jayol discloses a pelvic floor rehabilitation device including a handle ([0136]: “The sheath multi-purpose protrusion 16D is also a handle”) wherein the handle has an ergonomic design to allow a user to hold the handle and manipulate the device during use (Fig 40A element 16D), and wherein the handle includes at least one input control button engageable by the user during operation of the device ([0136]: “The sheath multi-purpose protrusion 16D may comprise an electronic part 18”, [0141]: “one electronic part 18 having… a push button”), a controller to receive instructions and to control operation of the pelvic floor rehabilitation device ([0013]: “The user via the controller can increase or decrease the girth of the shaft of the device.”), wherein controller is communicatively coupled to a computing device which transmits preprogrammed instructions for operation of the pelvic floor rehabilitation device ([0141]: “predetermined operative functions….The electronic part 18 is operated by the user via the electronic controller of the electronic part 18 and/or via a computer program designed to run on a desktop computer and/or mobile device”); and a plurality of input controls engageable by a user and communicatively coupled to the controller to control the pelvic floor rehabilitation device during operation ([0141]: “an electronic controller such as, but not limited to: a knob, a push-button, a switch and/or a tactile switch”).
As Liu discloses that the pelvic floor rehabilitation device may be controlled to perform automatic actions (page 4 para 1: “can automatically inflating and deflating the air bag 6, realizing non-linear following training.”) but does not specify a controller or instructions from a computing device, it would have been obvious to a person of ordinary skill in the art to modify the device disclosed by Liu to be communicatively coupled to a computing device in order to transmit the preprogrammed instruction as disclosed by Jayol in order to allow for the user to control the device remotely. It would additionally have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the handle disclosed by Liu with the handle disclosed by Jayol in order to provide the user greater control over the device.
While Liu discloses a temperature adjusting element, they fail to disclose the at least one temperature adjusting element includes resistive heating bands.
Hong discloses an insertable device ([0005]) wherein an at least one temperature adjusting element includes resistive heating bands ([0127]: “the heating element 22 is an electrically resistive coil that heats up when electric current is delivered to it from the power source 18”, Fig 11 element 92, wherein the heating element is a band around shaft element 90).
As Liu discloses a heating element, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known heating element disclosed by Liu to known the resistive heating element disclosed by Hong for the predictable result of providing heat.
Regarding claim 2, Jayol further discloses a transmitter for transmitting data collected by the at least one sensor to at least a first receiving computing device ([0151]: “a transmitter, and/or a receiver, such that when a heartbeat and/or changes in blood flow is detected by the transmitter, a signal is transmitted (by electrical wire, by wireless technology, and/or by low-power radio link) to the receiver”).
Regarding claim 3, Jayol further discloses the instructions are customizable for the user ([0014]).
Regarding claim 5, Liu discloses wherein the shaft comprises at least one dilation element (Page 2 para 6: “the head is provided with an air bag capable of inflating and deflating; the rehabilitation training of pelvic floor muscle is realized by repeatedly inflating and deflating the air bag.”), and wherein the at least one dilation element radially expands (page 4 para 2: “the airbag 6 may preferably be an annular, the airbag 6 around the head 1 is set.”)
Regarding claim 9, Liu further discloses at least one sensor comprises a pressure sensor to detect a resistance from a vagina (Page 4 para 3: “is provided with a pressure sensor for detecting the pressure between the air bag 6 and the muscle in use. The pressure sensor can monitor the pressure between the air bag 6 and the muscle in real time”).
Regarding claim 10, Liu further discloses wherein the at least one sensor comprises a pressure sensor to detect an air pressure within a dilation element of the shaft (Page 4 para 3: “is provided with a pressure sensor for detecting the pressure between the air bag 6 and the muscle in use. The pressure sensor can monitor the pressure between the air bag 6 and the muscle in real time”).
Regarding claim 11, Liu further discloses wherein the at least one sensor comprises a temperature sensor to measure the temperature inside a vagina (Page 4 para 6: “The temperature monitoring device, such as temperature sensor”).
Regarding claim 21, Jayol further discloses that the controller further includes a plurality of LEDs to provide information to the user during operation of the pelvic floor rehabilitation device ([0141]: “at least one electronic part 18 having … a light-emitting diode (LED)”).
Regarding claim 26, Jayol further discloses that the plurality of input controls perform at least two of: turning the device on and off, starting a session of instructions, providing lubricant, decreasing dilation ([0013: “The user via the controller can increase or decrease the girth of the shaft of the device”), and adjusting temperature ([0149]: “The heating element is preferably operated via the electronic part 18.”, [0141]: “The electronic part 18 is operated by the user via the electronic controller of the electronic part 18”).
Regarding claim 30, Liu further discloses wherein the at least one pressure sensor includes a pressure sensor to measure both an air pressure within a dilation element of the shaft and a force applied to the pressure sensor by the vagina (Page 4 para 3: “is provided with a pressure sensor for detecting the pressure between the air bag 6 and the muscle in use. The pressure sensor can monitor the pressure between the air bag 6 and the muscle in real time”).
Claim(s) 8, 22, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Jayol in view of Hong in further view of Beer et al. (WO 2018023037 A1).
Regarding claim 8, Liu as modified by Jayol discloses the pelvic floor rehabilitation device of claim 1 but fails to disclose a lubrication system.
However, Beer discloses a pelvic floor rehabilitation device (abstract) including a lubrication system operable to lubricate a vagina (page 29 lines 10-11 "The solid may include one or more diluents, densification agents, bulking agents, lubricating agents, glidants, or osmotic agents" Figure 7c element 103).
It would have been obvious to a person of ordinary skill before the effective filing date to modify the device taught by Juravic with the lubrication system taught by Beer in order to improve comfort and ease insertion or removal of the device from the vagina (page 38 lines 14-15).
Regarding claim 22, Liu as modified by Jayol discloses the device of claim 2, but fails to disclose Beer further discloses the first computing device includes a graphical user interface (GUI) and is configured to run a pelvic floor rehabilitation device application to display data to the user on the GUI during operation of the pelvic floor rehabilitation device.
Beer discloses a pelvic floor rehabilitation device (abstract) wherein the first computing device includes a graphical user interface (GUI) and is configured to run a pelvic floor rehabilitation device application to display data to the user on the GUI during operation of the pelvic floor rehabilitation device (Fig 22A-22D).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Liu as modified by Jayol to include the GUI as disclosed by Beer in order to allow for real-time feedback to the user (Page 43 lines 15-22).
Regarding claim 24, Liu, Jayol, and Beer disclose the device of claim 8. Beer further discloses the pelvic floor rehabilitation device is configured to accept a lubrication cartridge into the lubrication system (Page 29 lines 9-11: “reservoir is filled with a solid drug-containing polymer, e.g., as pellets or as a single core. The solid may include one or more diluents, densification agents, bulking agents, lubricating agents,”).
Regarding claim 25, Liu, Beer, and Jayol disclose the device of claim 8. Beer further discloses wherein lubricant is released from the lubrication system using one of the plurality of input controls (Page 8 lines 33-36: “The intravaginal device can be configured to control the rate of pharmaceutical agent release (e.g., continuous release, periodic release, or release in response to, e.g., user input, a stimuli, and/or sensor data obtained by the intravaginal device)”).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Jayol in view of Hong in further view of Noar (US 20180104457 A1).
Regarding claim 27, Liu discloses that the dilation element expands radially with air (page 4 para 2: “the airbag 6 may preferably be an annular, the airbag 6around the head 1 is set.”), but fails to disclose wherein the shaft comprises at least two dilation elements comprising silicone overmolded onto the shaft, and wherein each dilation element is separately controlled.
Jayol further discloses silicone overmolded onto the shaft ([0135]: “sheath 16 is made with a soft and resilient material such as, but not limited to: silicone, silicone-based and/or rubber material”).
It would have been obvious to a person of ordinary skill in the art to modify the device disclosed by Liu to include the silicone overmolding as disclosed by Jayol in order to improve patient comfort during use of the device by using a soft but durable material.
Noar discloses a dilating internal anchoring device (abstract) wherein the shaft comprises at least two dilation elements (Fig 1 elements 12 and 14) and wherein each dilation element is separately controlled ([0012]: “Instead of using a single second lumen 24 to inflate the balloon portions 12 and 14 generally simultaneously, a separate lumen (not shown) could be used to inflate each balloon portion 12 and 14 individually.”)
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Liu as modified by Jayol to include two dilation elements and the individual controlling as disclosed by Noar in order to prevent unwanted movement of the device by ensuring that the device conforms to the shape of the user (Noar [0016]: “The internal volumes of at least each of the proximal balloon portion and the distal balloon portion are inflated to thereby limit movement of the balloon structure in the bodily passage”).
Response to Arguments
Applicant’s arguments, see applicant’s arguments, filed 11/11/2025, with respect to the rejection(s) of claim(s) 1-3, 5, 8-12, and 21-30 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 USC 103 (see above).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791