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 Arguments
Applicant's arguments filed 4 March 2026 have been fully considered but they are not persuasive. The rejection(s) of independent Claim 1 under 35 U.S.C. § 102 with respect to the arrangement of parts, paragraph 40 states "In some embodiments, a valve 530 can be placed in the proximal portion 505 of the catheter". This embodiment addresses applicants' assertion that Herrera does not disclose the claimed arrangement of components.
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The rejection(s) of independent Claim 1 under 35 U.S.C. § 102 with respect to the .
Applicant's arguments filed 4 March 2026 have been fully considered but they are not persuasive. Regarding the 35 U.S.C. § 103 rejection of claim 34, examiner respectfully disagrees that combining the retaining portion of Herrera, which is in contact with the inner wall of the bladder, with the bladder skirt of Drager does not teach the limitations of the claim. Examiner utilizes the internal position of the retaining portion of Herrera, and only utilizes Drager to teach the portion of the device in contact with the bladder being a skirt.
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 2018/0153671 hereinafter Herrera.
In regards to Claim 1: 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”); 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); 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 (Herrera, Paragraph 40; “the valve 530 can be placed on the neck of the bladder 550”).
In regards to Claim 2: 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: 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 11: 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: 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: 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: The device as claimed in claim 1,wherein the actuator comprises a capacitor (Herrera, Paragraph 0021; Figure 1 Item 130 &120).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0153671 hereinafter Herrera.
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.
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 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 2016/0135942 hereinafter Drager.
In regards to Claim 15: 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: 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: 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: 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.
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.
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 by Drager to the bladder management device of Herrera, the motivation being to provide a better retention method that also protect the bladder from leakage.
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 6,638,208 hereinafter Natarajan.
In Regards to Claim 26: 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 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) 8 - 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0153671 hereinafter Herrera in view of US 5,954,766 hereinafter Zadno-Azizi.
In regards to Claim 8: A modified Herrera teaches all of claims 6 & 1, but does not teach wherein the seal comprises a membrane extending between the valve and an inner wall of the device, wherein the membrane is arranged to deform as the valve moves between the open position and the closed position.
Zadno-Azizi teaches wherein the seal comprises a membrane extending between the valve and an inner wall of the device, wherein the membrane is arranged to deform as the valve moves between the open position and the closed position (Zadno-Azizi, Figure 10 Item 66) (Zadno-Azizi, Column 4 Line 45 – 57).
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 seal of Zadno-Azizi to the valve of Herrera, the motivation being to provide a create an interactive seal that uses the force of the actuator ensure the lack of leakage through the valve when sealed.
In regards to Claim 9: A modified Herrera teaches all of claim 8, and wherein the membrane is arranged in a folded configuration such that the membrane is partly folded back on itself so as to create an overlap and such that a movement of the valve between the open position and the closed position changes the amount of overlap (Zadno-Azizi, Figure 10 Item 66) (Zadno-Azizi, Column 4 Line 45 – 57).
In regards to Claim 10: A modified Herrera teaches all of Claim 9, and wherein the membrane is at least partly in the form of a tube with one end folded back inside itself. (Zadno-Azizi, Figure 10 Item 66) (Zadno-Azizi, Column 4 Line 45 – 57).
Conclusion
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 NOE R DIETZ whose telephone number is (571)272-1135. The examiner can normally be reached Mon-Fri 8am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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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