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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/27/2026 has been entered.
Response to Amendment
The amendment filed 05/27/2026 has been entered. Amendments to claims 1 and 30 and new claims 31 and 32 are acknowledged. Claims 1-3, 5, 9-12, 21-22, and 25-27, and 30-32 remain pending in the application. The claim amendments have sufficiently overcome every 112(b) rejection presented in the office action filed 01/27/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 25 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 25 depends on cancelled claim 8. For the purposes of examination, claim 25 will be assumed to be dependent on claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 9-11, 21, 25-26, 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 Howsam et al. (US 20140148740 A1).
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 the shaft is configures to be inserted into a vagina (Page 2 para 6: “placed in the body”), and 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 wherein the shaft includes an inner tube, 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”), the shaft includes an inner tube (Fig 3A to 3B element 14), 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.
Liu as modified by Jayol fails to disclose a lubrication system operable to introduce at least one of a lubricant and a pharmaceutical into the vagina, comprising: a lubrication cartridge insertable into a cartridge compartment of the handle, wherein the lubricant cartridge holds at least one of a lubricant and a pharmaceutical: a lubrication delivery tube, disposed within the inner tube of the shaft, wherein the lubrication delivery tube connects the lubrication cartridge to at least one opening at a distal end of the shaft, and a lubricant pump, configured to release the at least one of a lubricant and a pharmaceutical into the vagina through the at least one opening.
Howsam discloses a lubrication system (title) operable to introduce at least one of a lubricant and a pharmaceutical into the vagina ([0022]: “device for targeted delivery of a lubricant to an orifice”), comprising: a lubrication cartridge ([0041]: “one-time use lubricant cartridge 300”) insertable into a cartridge compartment of the handle ([0038]: “a lubricant reservoir compartment 220 located between the tip 170 and the handle 106, which compartment 220 (defined within a body section of the core) is accessible through a door 222;”), wherein the lubricant cartridge holds at least one of a lubricant and a pharmaceutical ([0041]: “containing a water- or oil-based lubricant”): a lubrication delivery tube, disposed within the inner tube of the shaft (Fig 6 element 408), wherein the lubrication delivery tube connects the lubrication cartridge to at least one opening at a distal end of the shaft ([0043]: “cartridge fluid therefore able to flow (or be encouraged to seep or otherwise exit) from the lubricant cartridge into the lubricant delivery pipe 408”), and a lubricant pump, configured to release the at least one of a lubricant and a pharmaceutical into the vagina through the at least one opening ([0053]: “a peristaltic pump to control release of cartridge fluid 301 from the one-use lubricant cartridge 300”).
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 lubrication system disclosed by Howsam in order to improve user comfort during device operation ( Howsam [0011]).
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 25, Howsam discloses wherein lubricant is released from the lubrication system using one of the plurality of input controls ([0014]: “Under selective microprocessor control, the peristaltic pump spins its rotor assembly to engage and squeeze part of the pipe network, with this squeezing effect encouraging lubricant, liquid hormonal stimulant or other chemical solution to exit the cartridge and controllable”, [0029]: “The handle usually incorporates a control interface 108, such as buttons 110, for selecting and controlling operating programs/parameters of the vibrator 100”).
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 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) 12 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Jayol in view of Howsam in further view of Beer et al. (WO 2018023037 A1).
Regarding claim 12, Liu as modified by Jayol and Howsam discloses the device of claim 1, but fails to disclose wherein the at least one sensor comprises a moisture sensor to measure a level of moisture inside a vagina.
Beer discloses a pelvic floor rehabilitation device (abstract) wherein the at least one sensor comprises a moisture sensor to measure a level of moisture inside a vagina (page 15 lines 3-5 “by the inclusion of sensors that enable monitoring, such as real-time monitoring, of, e.g., hormone levels, toxin levels, pH levels, moisture levels,”).
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, Jayol, and Howsam to include the moisture sensor disclosed by Beer in order to obtain a more robust data set.
Regarding claim 22, Liu as modified by Jayol and Howsam discloses the device of claim 2, but fails to disclose 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).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Jayol in view of Howsam 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”).
Claim(s) 31 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Jayol in view of Howsam in further view of Barasch (US 20180193620 A1).
Regarding claim 31, Liu as modified by Jayol and Howsam discloses the device of claim 1, but fails to disclose wherein the temperature adjusting system adjusts a temperature of the lubricant released by the lubrication system.
Barasch disclose wherein a temperature adjusting system adjusts a temperature of the lubricant released by a lubrication system ([0004]: “The device may include a heating element to heat the lubricant prior to dispensing”).
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, Jayol, and Howsam to include adjustment of the lubricant released by the lubrication system in order to improve patient comfort.
Regarding claim 32, Liu as modified by Jayol and Howsam discloses the device of claim 1, but fails to disclose wherein the temperature adjusting system adjusts a temperature of the lubrication cartridge.
Barasch disclose wherein the temperature adjusting system adjusts a temperature of the lubrication cartridge ([0004]: “The device may include a heating element to heat the lubricant prior to dispensing”).
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, Jayol, and Howsam to include adjustment of the lubricant released by the lubrication system in order to improve patient comfort.
Response to Arguments
Applicant’s arguments, see applicant’s arguments, filed 05/27/2026, 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Alarcon (US 20110133910 A1) – discloses a heating system for a lubricant
Mizrahi (US 20130324792) – discloses a lubrication cartridge within a hollow tube of a device
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAVYA SHOBANA BALAJI whose telephone number is (703)756-5368. The examiner can normally be reached Monday - Friday 8:30 - 5:30 ET.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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