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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 13 July 2026 has been entered.
Response to Arguments
Applicant’s arguments, see Pages 7-9, filed 13 July 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. § 102 have been fully considered. Therefore, a rejection has been given in the alternative. Upon further consideration, a new ground(s) of rejection is made in view of US 2018/0153671 hereinafter Herrera in view of .
Applicant’s arguments, see Pages 9-11, filed 13 July 2026, with respect to the rejection(s) of claim(s) 34 under 35 U.S.C. § 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 Therefore, the rejection has been withdrawn.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 US 2018/0153671 hereinafter Herrera in view of US 5,782,916 hereinafter
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.
(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) 1, 2, 4, 11, 19, 20, & 30 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by US 2017/0314374 hereinafter Lundberg.
In regards to Claim 1: Herrera teaches of a device for controlling urinary flow, comprising:
a fluid inlet (Lundberg, Paragraph 21; Figure 2 Item 2500);
a fluid outlet (Lundberg, Paragraph 21; Figure 2 Item 2215);
a valve (Lundberg, Paragraph 21; Figure 2 Item 2000) movable between an open position in which fluid can flow from the fluid inlet to the fluid outlet(Lundberg, Figure 2; “Valve Sleeve Blocking Flow [Fully Closed]”) and a closed position in which fluid flow is blocked between the fluid inlet and the fluid outlet (Lundberg, Figure 2; “Injection Pressure Operated Configuration [Fully Open]”);
a valve seat located between the fluid inlet and the fluid outlet and arranged such that the valve engages with the valve seat in the closed position (Lundberg, Figure 2 Item 2220)
wherein when the valve is in the open position, a flow path is formed between the fluid inlet and the fluid outlet (Lundberg, Figure 2 arrows; “Injection Pressure Operated Configuration [Fully Open]”); and
an actuator operable to move the valve between the open position and the closed position (Lundberg, Paragraph 24; Figure 2 Item 2400; “bellows actuated valve)
wherein the actuator is positioned on a first side of the fluid inlet (Lundberg, Paragraph 21; Figure 2 Item 2400); and
wherein the fluid outlet is positioned on a second, opposite side of the fluid inlet (Lundberg, Paragraph 21; Figure 2 Item 2215); and
wherein the valve seat is located close to the fluid inlet such that the valve is operable to move substantially out of a flow path when the valve is in the open position (Lundberg, Figure 2).
In regards to Claim 2: Lundberg teaches of the device as claimed in claim 1, comprising an outlet tube extending between the fluid inlet and the fluid outlet (Lundberg, Paragraph 21; Figure 2 Item 2200).
In regards to Claim 4: Lundberg teaches of the device as claimed in claim 1, wherein the device is elongate and comprises a first section comprising the actuator (Lundberg, Paragraph 21; Figure 2 Item 2300) and a second section comprising the fluid outlet and wherein the fluid inlet is formed in a side wall of the device at a position between the first section and the second section (Lundberg, Paragraph 21; Figure 2 Item 2200).
In regards to Claim 35: A modified Herrera teaches of the device as claimed in claim 1, wherein the valve is operable to move completely out of the flow path when the valve is in the open position (Lundberg, Figure 2; “injection operated configuration”).
In regards to Claim 36: A modified Herrera teaches of the device as claimed in claim 1, wherein the valve is operable to move from the second side of the fluid inlet in the closed position (Lundberg, Figure 2; “valve sleeve blocking flow”) to the first side of the fluid inlet in the open position (Lundberg, Figure 2; “injection operated configuration”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5, 11, 19, & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0153671 hereinafter Herrera in view of US 2017/0314374 hereinafter Lundberg.
In regards to Claim 1: Herrera teaches of a device for controlling urinary flow, comprising:
a fluid inlet (Herrera, Paragraph 40; Figure 5 Item 505);
a fluid outlet (Herrera, Paragraph 40);
a valve movable between an open position in which fluid can flow from the fluid inlet to the fluid outlet and a closed position in which fluid flow is blocked between the fluid inlet and the fluid outlet (Herrera, Paragraph 40; Figure 5 Item 530);
a valve seat located between the fluid inlet and the fluid outlet and arranged such that the valve engages with the valve seat in the closed position (Herrera, Paragraph 40; “In some embodiments, a valve 530 can be placed in the proximal portion 505 of the catheter”);
wherein when the valve is in the open position, a flow path is formed between the fluid inlet and the fluid outlet (Herrera, Paragraph 38; “the urine in the bladder 550 can be voided when the user utilizes an external actuator 545 to open the valve 530 and allows the urine to travel through the urethra 560. This signal can be controlled by the user through the use of an external computing device 535.”); and
an actuator operable to move the valve between the open position and the closed position (Herrera, Paragraph 40; “valve 530 can comprise an internal actuator”);
wherein the actuator is positioned on a first side of the fluid inlet (Herrera Paragraph 40; valve 530 which contains an actuator is arranged upstream of the inlet); and
wherein the fluid outlet is positioned on a second, opposite side of the fluid inlet (Herrera, Paragraph 40; Outlet is downstream from the inlet).
However, Herrera does not teach wherein the valve seat is located close to the fluid inlet such that the valve is operable to move substantially out of a flow path when the valve is in the open position.
Lundberg teaches wherein the valve seat is located close to the fluid inlet such that the valve is operable to move substantially out of a flow path when the valve is in the open position (Lundberg, Figure 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the valve moving substantially out of the flow path taught in Lundberg to the urinary control device of Herrera, the motivation being to provide an unobstructed flow path for urinary evacuation.
In regards to Claim 2: A modified Herrera teaches of the device as claimed in claim 1, comprising an outlet tube extending between the fluid inlet and the fluid outlet (Herrera, Figure 6B Item 645; Paragraph 004).
In regards to Claim 4: A modified Herrera teaches of the device as claimed in claim 1, wherein the device is elongate and comprises a first section comprising the actuator (Herrera, Figure 5 Item500; Paragraph 0036 & 0040) and a second section comprising the fluid outlet and wherein the fluid inlet is formed in a side wall of the device at a position between the first section and the second section (Herrera, Paragraph 0037 & 0040).
In regards to Claim 5: One embodiment of Herrera teaches all of claims 4 and 1, but does not teach wherein the device is insertable into a urethra and is arranged such that, in use, the first section is located in a bladder and the second section is located in the urethra.
Another embodiment of Herrera teaches wherein the device is insertable into a urethra and is arranged such that, in use, the first section is located in a bladder and the second section is located in the urethra (Herrera, Figure 5 Item 500; Paragraph 0040).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the location of the first and second section components in one embodiment of Herrera with the previously utilized embodiment of Herrera, the motivation being to allow for a more comfortable and natural experience during use by keeping the urine in the bladder until it needs to be evacuated.
In regards to Claim 11: A modified Herrera teaches of the device as claimed in claim 1,wherein the device further comprises a first positioning structure movable between a stored configuration and a deployed configuration and wherein, in use, the first positioning structure prevents the device from exiting the bladder through the urethra. (Herrera, Figure 3 Item 315; Figure 5 Item 515, Paragraph 0034)
In regards to Claim 19: A modified Herrera teaches of the device as claimed in claim 1,wherein the device further comprises a second positioning structure movable between a stored configuration and a deployed configuration and wherein, in use, the second positioning structure is arranged to prevent movement of the device towards the bladder. (Herrera, Figure 7A Item 710; Paragraph 0045)
In regards to Claim 20: A modified Herrera teaches of the device as claimed in claim 19, wherein the second positioning structure is designed to contact a urethra wall when in the deployed configuration (Herrera, Figure 7A Item 750; Paragraph 0047).
In regards to Claim 30: A modified Herrera teaches of the device as claimed in claim 1,wherein the actuator comprises a capacitor (Herrera, Paragraph 0021; Figure 1 Item 130 &120).
In regards to Claim 35: A modified Herrera teaches of the device as claimed in claim 1, wherein the valve is operable to move completely out of the flow path when the valve is in the open position (Lundberg, Figure 2; “injection operated configuration”).
In regards to Claim 36: A modified Herrera teaches of the device as claimed in claim 1, wherein the valve is operable to move from the second side of the fluid inlet in the closed position (Lundberg, Figure 2; “valve sleeve blocking flow”) to the first side of the fluid inlet in the open position (Lundberg, Figure 2; “injection operated configuration”).
Claim(s) 6 & 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0153671 hereinafter Herrera in view of US 2017/0314374 hereinafter Lundberg in view of US 2003/0225311 hereinafter Sayet.
In regards to Claim 6: One embodiment of Herrera teaches all of claim 1, but does not teach a seal arranged between the fluid inlet and the actuator to prevent fluid flowing from the fluid inlet to the actuator.
Sayet teaches a seal arranged between the fluid inlet and the actuator to prevent fluid flowing from the fluid inlet to the actuator (Sayet, Paragraph 0082; Figure 12 Item 1200)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the sealed actuator compartment taught by Sayet to the urinary control device of Herrera , the motivation being to provide a water tight space to protect the electronic components in the actuator to prevent any electronic malfunction.
In regards to Claim 7: A modified Herrera teaches wherein the actuator is located in a sealed compartment, wherein the sealed compartment is at least partially formed by the seal (Sayet, Paragraph 0082; Figure 12 Item 1204)
Claim(s) 15, 17, 18, 22 & 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0153671 hereinafter Herrera in view of US 2017/0314374 hereinafter Lundberg in view of US 2016/0135942 hereinafter Drager.
In regards to Claim 15: A modified Herrera teaches all of claims 1 and 11, but does not teach wherein the first positioning structure comprises a skirt.
Drager teaches wherein the first positioning structure comprises a skirt (Drager, Figure 1A Item 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the bladder skirt taught in Drager to the bladder control device of Herrera, the motivation being to ensure that there is no leakage from the bladder due to the device.
In regards to Claim 17: A modified Herrera teaches all of claims 1 and 11, but does not teach wherein the first positioning structure is attached to the device at a position between the fluid inlet and the fluid outlet and adjacent to the fluid inlet.
Drager teaches wherein the first positioning structure is attached to the device at a position between the fluid inlet and the fluid outlet and adjacent to the fluid inlet (Drager, Figure 1A Item 20 & 84).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the bladder skirt placed adjacent to the inlet taught by Drager to the bladder control device of Herrera, the motivation being to ensure that there is no leakage from the bladder due to the device.
In regards to Claim 18: A modified Herrera teaches of claims 1 and 11, but does not teach wherein the first positioning structure is arranged when in the deployed configuration to position the fluid inlet adjacent to a urethral opening in the bladder.
Drager teaches wherein the first positioning structure is arranged when in the deployed configuration to position the fluid inlet adjacent to a urethral opening in the bladder (Drager, Figure 1A Item 20 & 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the retention structure in the position described to the bladder control device of Herrera, the motivation being to provide a structure to funnel urine out of the bladder effectively without any leakage of the bladder.
In regards to Claim 22: A modified Herrera teaches all of claim 1, but does not teach wherein the actuator comprises a solenoid arranged to impart a linear force on the valve to move it between the open position and the closed position.
Drager teaches wherein the actuator comprises a solenoid arranged to impart a linear force on the valve to move it between the open position and the closed position (Drager, Paragraph 0150) (Drager, Figure 6C. Item 68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the Solenoid structure taught by Drager to the valve actuator of Herrera, the motivation being to provide a method to remotely actuate the valve to allow the flow of urine.
Claim(s) 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0153671 hereinafter Herrera in view of US 2017/0314374 hereinafter Lundberg in view of US 6,638,208 hereinafter Natarajan.
In Regards to Claim 26: A modified Herrera all of claim 1, but does not teach wherein the actuator comprises a battery and an electronic control circuit.
Natarajan teaches wherein the actuator comprises a battery and an electronic control circuit (Natarajan, Column 4 Line 65 – 67) (Natarajan, Figure 3 Items 18 & 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the electronic control system of Natarajan to the bladder control device of Herrera, the motivation being to provide an external method of control for the device to increase the ease of use.
In regards to Claim 27: A modified Herrera teaches all of claim 26, and wherein the electronic control circuit is arranged to receive a wireless signal from an external source and operate the valve in response to said signal (Natarajan, Figure 4 Item 18; Column 6 Line 12 – 15).
In regards to Claim 28: A modified Herrera teaches all of claim 27, and wherein the electronic control circuit is arranged to receive a radio frequency (RF) signal from a remote control that is manually operable by a user of the device (Natarajan, Figure 4 Item 18; Column 6 Line 12 – 15).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0153671 hereinafter Herrera in view of US 2017/0314374 hereinafter Lundberg in view of US 2016/0135942 hereinafter Drager as applied to claim 22 above and further in view of US 2011/0015738 hereinafter Vaingast.
In regards to Claim 23: A modified Herrera teaches all of claim 22, but does not teach wherein the solenoid is a latching solenoid, which is able to maintain two or more set positions without a constant application of electrical power.
Vaingast teaches wherein the solenoid is a latching solenoid, which is able to maintain two or more set positions without a constant application of electrical power (Vaingast, Paragraph 0027) (Vaingast, Figure 2 Items 222)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the latching solenoid taught by Vaingast to the bladder control device of Herrera, the motivation being to provide a method to limit the amount of energy needed to hold multiple positions of the actuator.
Claim(s) 34 & 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0153671 hereinafter Herrera in view of US 5,782,916 hereinafter Pintauro.
In regards to Claim 34: Herrera teaches of a device for controlling urinary flow, comprising:
a fluid inlet (Herrera, Paragraph 0040; Figure 5 Item 505);
a fluid outlet (Herrera, Paragraph 0040);
a valve movable between an open position in which fluid can flow from the fluid inlet to the fluid outlet and a closed position in which fluid flow is blocked between the fluid inlet and the fluid outlet (Herrera, Paragraph 0040; Figure 5 Item 530); and
an actuator operable to move the valve between the open position and the closed position (Herrera, Figure 6B Items 625 & 635; Paragraph 0042);
wherein the device further comprises a first positioning structure movable between a stored configuration and a deployed configuration and wherein, in use, the first positioning structure is designed to contact an inner wall of the bladder when in the deployed configuration (Herrera, Figure 5 Item 515; Paragraph 036; Retention element 515 is inside of the bladder);
Herrera does not teach of the first positioning structure comprising a skirt and wherein, in use, the skirt is adapted to receive a pressure exerted by urine retained in the bladder to press the skirt against the inner wall of the bladder, thereby improving a seal between the device and a urethral opening.
Pintauro teaches wherein the first positioning structure comprises a skirt (Pintauro, Figure 5 Item 14) and wherein, in use, the skirt is adapted to receive a pressure exerted by urine retained in the bladder to press the skirt against the inner wall of the bladder, thereby improving a seal between the device and a urethral opening (Pintauro, Column 5 Lines 47-64 & Column 4 Lines 3-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the bladder skirt taught by Pintauro to the bladder management device of Herrera, the motivation being to provide a better retention method that also protect the bladder from leakage and retain the device inside the body.
In Regards to Claim 37: A modified Herrera teaches all of claim 34 and wherein the skirt comprises a continuous impermeable layer (Pintauro, Column 4 Lines 12-14; Column 8 Lines 38-44).
Conclusion
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/N.R.D./Patent Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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