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
Applicant’s amendment, filed 15 October 2025, is acknowledged. Claims 1 , 5, 15 and 21 are amended. Claim 22 is marked as amended, but does not appear to have changed since the last claim set. Claim 13 is cancelled. Claims 9, 10, 14, 16, 18-20, 24-27, 29-36 and 38-42 were previously cancelled. Claim 37 remains withdrawn from consideration.
Claims 1-8, 11, 12, 15, 17, 21-23, 28 and 37 are pending in the instant application.
Response to Arguments
Applicant’s arguments, filed 15 October 2025, with respect to the objections to claims 1 and 21, have been fully considered and are persuasive in light of the amendment. The objections to claims 1 and 21 have been withdrawn.
Applicant's arguments, filed 15 October 2025, regarding the 35 USC 103 rejections of claims 1 and 21, have been fully considered but they are not persuasive. Claims 1 and 21 are amended to include the limitation “an external seal member configured to surround at least a part of the valve main body to aid in providing a seal between the valve and a urethral wall,”. Claim 13 previously recited the limitation that was amended into claim 1 and 21. Claim 13 was previously rejected as being obvious over Wilkie (US20080269546A1) in view of Davis (US9011314B2), and further in view of Von Iderstein (US6105580A).
As applicant does not present arguments as to why modified Wilkie is not obvious over claim 13, therefore applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Amended claim 1 remains rejected as being obvious over Wilkie in view of Davis, and further in view of Von Iderstein and amended claim 21 remains rejected as being obvious over Wilkie in view of Davis, and further in view of Von Iderstein and Davis (US6066088A).
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.
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, 2, 7, 8, 11-12, 15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkie (US20080269546A1), in view of Davis (US9011314B2), further referred to as Davis ‘314, and further in view of Von Iderstein (US6105580A).
Regarding claim 1, Wilkie discloses an intraurethral magnetic valve having an inlet port and an outlet port (Abstract "The invention emulates the operation of a healthy urethra by providing a valve with a large differential between the opening pressure and the closing pressure" Figure 3.), the valve including a valve main body (Figure 3. valve "4"); a ferromagnetic ring located at least partially within the valve main body (Figure 3. magnetic ring "7" is embedded inside valve "4"); a valve seat (Figure 3 "10" which is not declared in the specification. Paragraph [0015] "The ball 8 is held securely in place in housing 4 and forms a good seal, particularly with an elastomeric housing, until urine pressure separates it slightly from its seat.") wherein the valve seat is formed from an elastomer material (Paragraph [0013] "The body of valve 4 is made of metal, ceramic or a polymeric material such as silicone rubber or polyurethane." The valve seat is integral with the body.); and a magnetic valve element (Figure 3. Ball "8' Paragraph [0013] "a corrosion resistant ball made of ferromagnetic material such as type 400 stainless steel") located within an internal volume defined by the valve main body and configured for movement with respect to the ferromagnetic ring, said movement being within the valve main body between a closed configuration in which fluid is inhibited from flowing from the inlet port through the outlet port and an open configuration in which fluid is permitted to flow from the inlet port through the outlet port (Paragraph [0015] "The ball 8 is held securely in place in housing 4 and forms a good seal, particularly with an elastomeric housing, until urine pressure separates it slightly from its seat."), movement of the magnetic valve element being on exposure to a magnetic field from an external magnet member ("Since ball 8 is ferromagnetic, valve can always be activated by placing a strong magnet outside the body in the vicinity of the urethra. This will allow emptying the bladder even before full pressure was reached.") and an external seal member configured to surround at least a part of the valve main body to aid in providing a seal between the valve and a urethral wall (Paragraph [0022] "By the way of example, grooves 11 can have a thin silver rings at the bottom of each groove." The silver rings can be considered the external seal member because they aid the grooves and ridges.).
Wilkie does not disclose the valve seat is an offset valve seat such that the outlet is offset from a central longitudinal axis of the internal volume defined by the valve main body. Davis ‘314 discloses a catheter having a valve disposed at a distal portion of the catheter (abstract), wherein the centerline of a valve seat aperture parallel to but displaced from the centerline of a cylindrical housing (Figure 5, aperture “31” of the valve seat “22” is offset from the central longitudinal axis of valve “5”, Col 7, lines 7-12). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the valve as taught by Wilkie, with the valve seat is an offset valve seat such that the outlet is offset from a central longitudinal axis of the internal volume defined by the valve main body as taught by Davis ‘314, since by displacing the centerline, the spherical valve element may be restrained from closing the valve by passing an extendible element the valve seat in the valve (Col 7, lines 7-12).
Wilkie does not disclose the valve seat comprises a circumferential inclined surface configured to contact the magnetic valve element. Davis ‘314 discloses the offset valve seat comprises an inclined surface configured to contact the magnetic valve element (Figure 5, valve seat “22”). Davis ‘314 does not explicitly disclose that the inclined surface (Figure 5, valve seat “22”) is circumferential. Von Iderstein discloses an involuntary urine control device (Abstract) with an analogous valve system wherein the valve seat comprises a circumferential inclined surface configured to contact the valve element (Figures 2 and 4-5, valve seat “33”). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Wilkie and Davis ‘314 with a valve seat comprising a circumferential inclined surface configured to contact the magnetic valve element as taught by Von Iderstein, since such a modification would provide the predictable results of increasing the surface area contact between the valve seat and the magnetic valve element, thereby improving the seal of the valve.
Regarding claim 2, Wilkie, as modified in claim 1, further discloses a portion of the valve main body forms the valve seat with which the magnetic valve element is configured to engage when in the closed configuration (Figure 3 "10" which is not declared in the specification is the valve seat. Paragraph [0013] "The body of valve 4 is made of metal, ceramic or a polymeric material such as silicone rubber or polyurethane." The valve seat is integral with the body.).
Regarding claim 7, Wilkie, as modified in claim 1, further discloses the ferromagnetic ring is embedded in the elastomer material which forms the valve seat (Figure 3 (Figure 3 "10" which is not declared in the specification is the valve seat. Paragraph [0013] "The body of valve 4 is made of metal, ceramic or a polymeric material such as silicone rubber or polyurethane." The valve seat is integral with the body. Figure 3. magnetic ring "7" is embedded inside valve "4").
Regarding claim 8, Wilkie, as modified in claim 1, further discloses that a tool can be passed through the valve, but requires the removal of the ball (Paragraph 0027). Davis ‘314 discloses the magnetic valve element is configured to adopt an open pass-through configuration in which a path is provided through the valve for an extendible member (Figure 5, where in magnetic valve element “25” is displaced to an open pass configuration (Col 9, lines 38-41 “By transit through valve 5, extendible element 9 displaces spherical magnetic valve element 25 from seat 22 causing the valve to be held open and able to pass 40 liquid during implantation.”) and there is a path for the extendible element “9” to pass through the valve “5”). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the valve as taught by Wilkie, as modified in claim 1, with the valve design of Davis ‘314 wherein a magnetic valve element that is configured to adopt an open pass-through configuration in which a path is provided through the valve for an extendible member as taught by Davis ‘314, since such a modification would provide the predictable results of allowing the magnetic ball in modified Wilkie to push to the side in a manner similar to Davis ‘314 to allow the extendable member to pass.
Regarding claim 11, Wilkie, as modified in claim 1, further discloses the valve main body is elastically deformable to reduce a width of the internal volume (Paragraph [0013] "The body of valve 4 is made of metal, ceramic or a polymeric material such as silicone rubber or polyurethane." If the main body is made of rubber, it would meet the limitations of the claim.).
Regarding claim 12, Wilkie, as modified in claim 1, further discloses further including one or more external ribs for engagement with a urethral wall (Paragraph [0013] "Referring now to FIG. 3, valve 4 is inserted into urethra 3 and in held in place by one or more grooves and ridges 11." Paragraph [0022] "By the way of example, grooves 11 can have a thin silver rings at the bottom of each groove." The silver rings or the grooves and ridges can be considered the external ribs.).
Regarding claim 15, Wilkie, as modified in claim 1, further discloses the external seal member includes an antimicrobial and/or antifungal agent ("Paragraph [0022] "By the way of example, grooves 11 can have a thin silver rings at the bottom of each groove." Silver has antimicrobial properties).
Regarding claim 17, Wilkie, as modified in claim 1, further discloses wherein the valve seat at least partially receives the magnetic valve element (Figure 3. The valve element is seated in the valve seat.).
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkie (US20080269546A1), Davis (US9011314B2) and Von Iderstein (US6105580A) as applied to claim 1 above, and further in view of Davis (US6066088A), further referred to as Davis ‘088.
Regarding claim 3, Wilkie, as modified in claim 1, further discloses a valve seat integrated into the main valve body. Wilkie and Davis ‘314 do not disclose the valve seat is fitted to the valve main body since it is integrated. Davis ‘088 discloses a valve seat assembly that is attached to the inner bore of a valve housing (Figure 1 valve seat assembly "36" valve seat "4" Col 4, lines 39-41 "A valve seat assembly 36 is sealingly attached to an inner bore 3(a) of the housing at one end 2(a) of the housing."). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the valve as taught by modified Wilkie, with a valve seat assembly as a separate component as taught by Davis ‘088, since such a modification would provide the predictable results of a mere substitution of the separate component for the integrated valve seat since both serve the same function and placement.
Regarding claim 4, Davis ‘088 further discloses the valve seat member is at least partially received by the valve main body (Figure 1 valve seat assembly "36" Col 4, lines 39-41 "A valve seat assembly 36 is sealingly attached to an inner bore 3(a) of the housing at one end 2(a) of the housing.").
Regarding claim 5, Davis ‘088 further discloses the ferromagnetic ring at least partially surrounds a portion of the valve seat member (Figure 1 The valve seat assembly "36" comprises a nonferromagnetic valve seat "4" and a ferromagnetic attractive ring "5" of high magnetic permeability. If substituting the Davis ‘088’s valve seat assembly for the integrated valve seat in modified Wilkie, the valve seat assembly would still be within the ferromagnetic ring as shown in Wilkie, figure 3.).
Regarding claim 6, Davis ‘088 discloses the valve seat member is formed of only an elastomer material (Col 5, lines 13-14 "Valve housing 2, valve seat 4, and retaining ring 10 are made of nonmagnetic biocompatible material," In light of Wilkie’s choice of polymeric material such as silicone rubber or polyurethane, it would have been obvious that the valve seat member material would be selected from the two since both are nonmagnetic biocompatible materials.).
Claims 21, 22, 23 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkie (US20080269546A1) in view of and Davis (US9011314B2), and further in view Von Iderstein (US6105580A) and Davis (US6066088A).
Regarding claim 21, Wilkie discloses an intraurethral magnetic valve having an inlet port and an outlet port (Abstract "The invention emulates the operation of a healthy urethra by providing a valve with a large differential between the opening pressure and the closing pressure" Figure 3.), the valve including a valve main body (Figure 3. valve "4"); a ferromagnetic ring located at least partially within the valve main body (Figure 3. magnetic ring "7" is embedded inside valve "4"); a valve seat (Figure 3 "10" which is not declared in the specification. Paragraph [0015] "The ball 8 is held securely in place in housing 4 and forms a good seal, particularly with an elastomeric housing, until urine pressure separates it slightly from its seat.") wherein the valve seat is formed from an elastomer material (Paragraph [0013] "The body of valve 4 is made of metal, ceramic or a polymeric material such as silicone rubber or polyurethane." The valve seat is integral with the body.); and a magnetic valve element (Figure 3. Ball "8' Paragraph [0013] "a corrosion resistant ball made of ferromagnetic material such as type 400 stainless steel") located within an internal volume defined by the valve main body and configured for movement with respect to the ferromagnetic ring, said movement being within the valve main body between a closed configuration in which fluid is inhibited from flowing from the inlet port through the outlet port and an open configuration in which fluid is permitted to flow from the inlet port through the outlet port (Paragraph [0015] "The ball 8 is held securely in place in housing 4 and forms a good seal, particularly with an elastomeric housing, until urine pressure separates it slightly from its seat."), movement of the magnetic valve element being on exposure to a magnetic field from an external magnet member ("Since ball 8 is ferromagnetic, valve can always be activated by placing a strong magnet outside the body in the vicinity of the urethra. This will allow emptying the bladder even before full pressure was reached.") and an external seal member configured to surround at least a part of the valve main body to aid in providing a seal between the valve and a urethral wall (Paragraph [0022] "By the way of example, grooves 11 can have a thin silver rings at the bottom of each groove." The silver rings can be considered the external seal member because they aid the grooves and ridges.).
Wilkie does not disclose the valve seat is an offset valve seat such that the outlet is offset from a central longitudinal axis of the internal volume defined by the valve main body. Davis ‘314 discloses a catheter having a valve disposed at a distal portion of the catheter (abstract), wherein the centerline of a valve seat aperture parallel to but displaced from the centerline of a cylindrical housing (Figure 5, aperture “31” of the valve seat “22” is offset from the central longitudinal axis of valve “5”, Col 7, lines 7-12). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the valve as taught by Wilkie, with the valve seat is an offset valve seat such that the outlet is offset from a central longitudinal axis of the internal volume defined by the valve main body as taught by Davis ‘314, since by displacing the centerline, the spherical valve element may be restrained from closing the valve by passing an extendible element the valve seat in the valve (Col 7, lines 7-12).
Wilkie does not disclose the valve seat comprises a circumferential inclined surface configured to contact the magnetic valve element. Davis ‘314 discloses the offset valve seat comprises an inclined surface configured to contact the magnetic valve element (Figure 5, valve seat “22”). Davis ‘314 does not explicitly disclose that the inclined surface (Figure 5, valve seat “22”) is circumferential. Von Iderstein discloses an involuntary urine control device (Abstract) with an analogous valve system wherein the valve seat comprises a circumferential inclined surface configured to contact the valve element (Figures 2 and 4-5, valve seat “33”). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Wilkie and Davis ‘314 with a valve seat comprising a circumferential inclined surface configured to contact the magnetic valve element as taught by Von Iderstein, since such a modification would provide the predictable results of increasing the surface area contact between the valve seat and the magnetic valve element, thereby improving the seal of the valve.
Wilkie, Davis ‘314 and Von Iderstein do not disclose the valve system further includes a catheter coupled to the inlet port of the valve, and a retention mechanism coupled to the catheter, wherein the retention mechanism is configured for deployment in a bladder. Davis ‘088 discloses in Figure 2, a catheter (flexible tube “20”) coupled to the inlet port of the valve (valve assembly “1”) and a retention mechanism (retaining loops (or rings) “28”) wherein the retention mechanism is configured for deployment in a bladder (See figure 3). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Wilkie, Davis ‘314 and Von Iderstein, with the catheter and retention mechanism as taught by Davis ‘088, since such a modification would provide the predictable results of installing Wilkie, Davis ‘314 and Von Iderstein’s valve in Davis ‘088 catheter assembly.
Regarding claim 22, Wilkie, as modified in claim 21, further discloses that a tool can be passed through the valve, but modified Wilkie does disclose an extendible element extending through the valve and catheter, and secured to at least part of the retention mechanism and a retaining clip configured to engage the extendible element and inhibit the movement thereof through the catheter. Davis ‘314 discloses an extendible element extending through the valve and catheter (Figure 2, extendible element “9”, valve “5”, catheter “1”) secured to at least part of the retention mechanism (Figures 8 and 9, catheter proximal tip “27”, socket “7” has a rectangular slot “45” to receive the proximal end of extendible element “9” approximately rectangular tip “26”) retaining clip configured to engage the extendible element and inhibit the movement thereof through the catheter (Col 10, lines 6-14 “In one embodiment, a biasing device 62, (shown in FIG. 15) such as an extension spring, is provided to bias the extendible element proximally to ensure the proximal tip 26 of extendible element 9 remains engaged in the socket 7. The biasing device 62 is configured to extend under a force. Thus, if the catheter becomes frictionally bound and tension is applied to the tool, the spring will extend to maintain engagement of the proximal element tip in the socket 7.”). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by modified Wilkie, with an extendible element extending through the valve and catheter, and secured to at least part of the retention mechanism and a retaining clip configured to engage the extendible element and inhibit the movement thereof through the catheter as taught by Davis ‘314, since such a modification would provide the predictable results of allowing the use of the extendible element to function within the device.
Regarding claim 23, Wilkie, as modified in claim 21, fails to disclose an external retention mechanism configured to inhibit migration of the valve system into the bladder. Von Iderstein discloses an outer flange 38 provides for the retaining of the apparatus against the outside of the subject's urethral opening, preventing the apparatus 10 from sliding within the urethra (Col 7, lines 39-41) which could further move into the bladder. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by modified Wilkie, with an outer flange that ensures the valve system does not move into the bladder as taught by Von Iderstein, since such a modification would provide the predictable results of simple modification to the tip of the valve to prevent the apparatus from sliding within a user’s urethra (Col 7, lines 39-41).
Regarding claim 28, Wilkie, as modified in claim 21, fails to disclose including an insertion tool for use in implantation of the valve system, wherein the insertion tool includes a sleeve member configured to receive at least part of the valve system. Davis ‘314 discloses the insertion tool (Figure 2, “8”) includes a sleeve (Figure 2, catheter segment “11”) that is configure to receive at least part of the valve system (tip member “10” which couples or locks tool “8” to the catheter “1”, Figure 5, tip member “10” is inside catheter “1”in a locking formation). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by modified Wilkie, with an insertion tool that includes a sleeve member configured to receive at least part of the valve system as taught by Davis ‘314, since such a modification would provide the predictable results of allowing the use of the extendible element to function within the device.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marc D Honrath whose telephone number is (571)272-6219. The examiner can normally be reached M-F 7:30-5:00.
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, Charles A Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./ Examiner, Art Unit 3791