DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02 December 2025 has been entered.
This Office Action is responsive to the Amendment filed 02 December 2025.
Claims 1 – 7 and 9 - 23 are now pending. The Examiner acknowledges the amendments to claims 1, 15 and 19.
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 .
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.
Claims 1 - 22 are rejected under 35 U.S.C. 103 as being unpatentable over Yachia et al (US 6398718 B1, hereinafter Yachia) in view of Connors et al (US 10531894 B2, filed 2017-09-20, hereinafter Connors) in view of Gardner et al (US 20160114140 A1, hereinafter Gardner).
Regarding claim 1, Yachia teaches a device for treating urinary incontinence ([0001]) comprising:
(a) a fillable (column 7, lines 54 - 57) expandable balloon (“body 200”, column 7, line 50; Figure 13) having a wall made of a flexible material enclosing a lumen (column 7, lines 49 – 51), the wall of the balloon (200), there being a valve (“self-sealing valve 205”, column 7, lines 58 – 59; Figure 13) in of the wall of the balloon (200) (Figure 13) and one or more magnetable elements (“metal rod 115”, column 7, line 16; Figure 13).
Yachia does not teach the wall of the balloon having at least one permanently formed recess, there being a valve positioned in the at least one permanently formed recess of the wall of the balloon and being spaced apart from an exterior surface of the balloon, (b) a central core located in the lumen of the balloon having an end adjacent to the valve, the central core comprising a wall enclosing a central channel and there being one or more openings in the wall of the central channel.
However, Connors discloses “Method and system for treating a patient using a compressible, pressure-attenuating device” (abstract) and teaches a wall (see annotated Connors’ Figure 99(a) below) of a balloon (“Cell 1711” column 61 lines 14 – 15; see annotated Connors’ Figure 99(a) below) having at least one permanently formed recess (see annotated Connors’ Figure 99(a) below), there being a valve (“valve 1713” column 61 line 13; Figures 99(a) - 100) positioned in the at least one permanently formed recess (see annotated Connors’ Figure 99(a) below) of the wall of the balloon (1711) and being spaced apart from an exterior surface (see annotated Connors’ Figure 99(a) below) of the balloon (1711) (see annotated Connors’ Figure 99(a) below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yachia such that the wall of the balloon having at least one permanently formed recess, there being a valve positioned in the at least one permanently formed recess of the wall of the balloon and being spaced apart from an exterior surface of the balloon, as taught by Connors, for the benefit of preventing scraping or injuries from the device/valve to the patient.
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The modified invention of Yachia and Connors does not teach (b) a central core located in the lumen of the balloon having an end adjacent to the valve, the central core comprising a wall enclosing a central channel and there being one or more openings in the wall of the central channel.
However, Gardner discloses a “balloon catheter having an elongated catheter shaft defining a fluid drainage lumen and a balloon inflation lumen” (abstract) and teaches (b) a central core (“catheter shaft 20”, [0029]) located in a lumen of a balloon having an end adjacent to the valve ([0029]), the central core (20) comprising a wall enclosing a central channel and one or more magnetable elements, there being one or more openings (“balloon inflation port 42”, Figures 1 – 4, [0027], [0031]) in the wall of the central channel ([0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yachia and Connors such that a central core located in the lumen of the balloon having an end adjacent to the valve, the central core comprising a wall enclosing a central channel and there being one or more openings in the wall of the central channel, as taught by Gardner, for the benefit of preventing the release of fluid back through the inflation connector and using the valves to control the fluid (Gardner: [0031]).
Regarding claim 2, Yachia, Connors and Gardner teach all limitations of claim 1. Yachia teaches the device ([0001]) comprising two or more magnetable elements (“The body has a magnetizable portion allowing it to be positioned in an outlet of the cavity by means of a hand-held magnet placed in the vicinity of the cavity.”, column 4, lines 54 - 59).
Regarding claim 3, Yachia, Connors and Gardner teach all limitations of claim 1. The current embodiment of Yachia does not teach the magnetable elements are toroidal rings.
However, another embodiment of Yachia teaches the magnetable elements are toroidal rings (“cylindrical-shaped magnet 925”, column 9, lines 32 - 33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yachia, Connors and Gardner such that the magnetable elements are toroidal rings, as taught by another embodiment of Yachia, for the benefit of being in contact with a hand-held magnet to rotate the body in the outlet of the cavity (Yachia: column 4, lines 58 - 59).
Regarding claim 4, Yachia, Connors and Gardner teach all limitations of claim 1. The modified Yachia teaches the central core (Gardner: “catheter shaft 20”, [0029]) surrounding the valve (Gardner: [0029]). The modified Yachia does not teach the magnetic elements is made from a flexible material.
However, another embodiment of Yachia teaches magnetic elements (“cylindrical-shaped magnet 925”, column 9, lines 32 - 33) is made from a flexible material (“flexibly resilient body”, column 4, lines 43 – 44). Examiner interprets the body to include the magnetic elements (925) and for both elements to be flexible.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yachia such that the magnetic elements is made from a flexible material, as taught by Yachia, for the benefit of compressing prior to insertion and then allowed to expanding after insertion in the cavity (Yachia: column 4, lines 50 - 51).
Regarding claim 5, Yachia, Connors and Gardner teach all limitations of claim 1. The modified teaches the central core (Gardner: “catheter shaft 20”, [0029]) is longitudinally incompressible (Figure 1). Examiner interprets the catheter shaft in Figure 1 depicts as longitudinally incompressible.
Regarding claim 6, Yachia, Connors and Gardner teach all limitations of claim 1. Yachia teaches the balloon (“body 200”, column 7, line 50; Figure 13) is filled with a fluid (column 7, lines 54 - 55).
Regarding claim 7, Yachia, Connors and Gardner teach all limitations of claim 6. Yachia teaches the wall of the filled balloon (“body 200”, column 7, line 50; Figure 13) is filled to less than a maximum volume of the balloon (column 8, lines 1 – 15; Figures 16A and 16B). Examiner interprets the balloon (200) can deform in Figure 16A.
Regarding claim 9, Yachia, Connors and Gardner teach all limitations of claim 1. Yachia teaches the balloon (“body 200”, column 7, line 50; Figure 13) is adapted to store one or more substances and releasing the substances into the urinary bladder (“delivery of drugs, imaging the cavity, and measuring intravehicular parameters such as pressure in the cavity or the composition of a body fluid in the cavity such as urine”, column 5, lines 5 - 6).
Regarding claim 10, Yachia, Connors and Gardner teach all limitations of claim 1. The current embodiment of Yachia does not teach the balloon further comprises imaging means for imaging the urinary bladder.
However, another embodiment of Yachia teaches a balloon (“body 200”, column 7, line 50; Figure 13) further comprises imaging means (column 10, lines 18 – 23; Figure 10) for imaging the urinary bladder. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yachia, Connors and Gardner such that the balloon further comprises imaging means for imaging the urinary bladder, as taught by Yachia, for the benefit of seeing in the wall of the bladder which is noted to be well known in the art (Yachia: column 10, lines 22 - 26).
Regarding claim 11, Yachia, Connors and Gardner teach all limitations of claim 1. Yachia teaches the balloon (“body 200”, column 7, line 50; Figure 13) further includes one or more monitoring means for monitoring urinary bladder parameters or measuring contents of the bladder (column 5, lines 58 - 67).
Regarding claim 12, Yachia, Connors and Gardner teach all limitations of claim 11. Yachia teaches the balloon (“body 200”, column 7, line 50; Figure 13) further comprises a transmitter (“transmitter 110”, column 10, lines 20 -23; Figure 10) for transmitting signals from the monitoring means to a receiver (“receiver 111”, column 10, line 23; Figure 10).
Regarding claim 13, Yachia, Connors and Gardner teach all limitations of claim 10. Yachia teaches the balloon further (“body 200”, column 7, line 50; Figure 13) comprises a data collector (“processing unit 112”, column 10, lines 25 - 27) for collecting data generated by imaging means (column 10, lines 18 – 23; Figure 10) or monitoring means (“display 113”, column 10, lines 25 - 27) associated with the balloon (200).
Regarding claim 14, Yachia, Connors and Gardner teach all limitations of claim 1. The current embodiment of Yachia does not teach the balloon further comprises one or more surface or antenna shaped electrodes.
However, another embodiment of Yachia teaches a balloon (“body 200”, column 7, line 50; Figure 13) further comprises one or more surface or antenna shaped electrodes (“electrodes”, column 10, lines 57 – 60; Figure 19). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yachia such that the balloon further comprises one or more surface or antenna shaped electrodes, as taught by Yachia, for the benefit of stimulating a hypotonic urinary bladder (Yachia: column 10, lines 51 - 53).
Regarding claim 15, Yachia teaches a system for treating urinary incontinence comprising:
(a) a device for treating urinary incontinence ([0001]) comprising:
a fillable (column 7, lines 54 - 57) balloon (“body 200”, column 7, line 50; Figure 13) having a wall made of a flexible material enclosing a lumen, the wall of the balloon (200) having at least one recess (recess of valve 205, column 7, lines 58 – 60, see annotated Yachia’s Figure 14 or recess of valve 208 in 205 where the valve 208 is clearly sitting in a recess in the wall of the balloon), there being a valve in the at least one recess (recess of valve 205, column 7, lines 58 – 60, see annotated Yachia’s Figure 14) of the wall of the balloon (200); and one or more magnetable elements (“metal rod 115”, column 7, lines 16; Figure 3).
Yachia does not teach the wall of the balloon having at least one permanently formed recess, there being a valve positioned in the at least one permanently formed recess of the wall of the balloon and being spaced apart from an exterior surface of the balloon, (b) a central core located in the lumen of the balloon having an end adjacent to the valve, the central core comprising a wall enclosing a central channel and there being one or more openings in the wall of the central channel.
However, Connors discloses “Method and system for treating a patient using a compressible, pressure-attenuating device” (abstract) and teaches a wall (see annotated Connors’ Figure 99(a) below) of a balloon (“Cell 1711” column 61 lines 14 – 15; see annotated Connors’ Figure 99(a) below) having at least one permanently formed recess (see annotated Connors’ Figure 99(a) below), there being a valve (“valve 1713” column 61 line 13; Figures 99(a) - 100) positioned in the at least one permanently formed recess (see annotated Connors’ Figure 99(a) below) of the wall of the balloon (1711) and being spaced apart from an exterior surface (see annotated Connors’ Figure 99(a) below) of the balloon (1711) (see annotated Connors’ Figure 99(a) below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yachia such that the wall of the balloon having at least one permanently formed recess, there being a valve positioned in the at least one permanently formed recess of the wall of the balloon and being spaced apart from an exterior surface of the balloon, as taught by Connors, for the benefit of preventing scraping or injuries from the device/valve to the patient.
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The modified invention of Yachia and Connors does not teach (b) a central core located in the lumen of the balloon having an end adjacent to the valve, the central core comprising a wall enclosing a central channel and there being one or more openings in the wall of the central channel.
However, Gardner discloses a “balloon catheter having an elongated catheter shaft defining a fluid drainage lumen and a balloon inflation lumen” (abstract) and teaches a central core (“catheter shaft 20”, [0029]) located in the lumen of the balloon having an end adjacent to the valve ([0029]), the central core (20) comprising a wall enclosing a central channel and there being one or more openings (“balloon inflation port 42”, Figures 1 – 4, [0027], [0031]) in the wall of the central channel ([0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yachia and Connors such that a central core located in the lumen of the balloon having an end adjacent to the valve, the central core comprising a wall enclosing a central channel and there being one or more openings in the wall of the central channel, as taught by Gardner, for the benefit of preventing the release of fluid back through the inflation connector and using the valves to control the fluid (Gardner: [0031]).
Regarding claim 16, Yachia, Connors and Gardner teach all limitations of claim 15. Yachia teaches the system comprises a delivery catheter (“applicator 31”, column 7, line 25; Figure 2) configured to deliver the device to a urinary bladder of an individual (column 7, lines 25 - 26).
Regarding claim 17, Yachia, Connors and Gardner teach all limitations of claim 15. Yachia teaches the system comprises a retrieval device (“retrieval device 51”, column 7, line 38; Figure 4) configured to remove the device from a urinary bladder of an individual (column 7, lines 38 – 39).
Regarding claim 18, Yachia, Connors and Gardner teach all limitations of claim 15. Yachia teaches the system comprising a syringe (“syringe 207”, column 8, lines 5; Figures 15 and 16b) configured to introduce a fluid into the balloon (column 7, lines 64 - 65) through one of the valves (“self-sealing valve 205”, column 7, lines 58 – 59; Figure 13) and to remove fluid from the balloon (“piecer 233”, column 8, lines 28 – 29; Figure 18) through one of the valves.
Regarding claim 19, Yachia teaches a method for treating urinary incontinence ([0001]) comprising:
(a) inserting into a urinary bladder of an individual a device ([0001]) for treating urinary incontinence comprising (column 7, lines 25 -27; Figure 2):
an expandable balloon (“body 200”, column 7, line 50; Figure 13) having a wall made of a flexible material enclosing a lumen (column 7, lines 49 – 51), the wall of the balloon having at least one recess (recess of valve 205, column 7, lines 58 – 60, see annotated Yachia’s Figure 14 or recess of valve 208 in 205 where the valve 208 is clearly sitting in a recess in the wall of the balloon), there being a valve (“self-sealing valve 205”, column 7, lines 58 – 59; Figure 13) in the at least one recess (recess of valve 205, column 7, lines 58 – 60, see annotated Yachia’s Figure 14) of the wall of the balloon (200) (Figure 13); one or more magnetable elements (“metal rod 115”, column 7, lines 16; Figure 3), and
(b) filling the lumen of the balloon (200) with a fluid (column 7, lines 64 - 65); and
(c) positioning the device ([0001]) in an opening of the urinary bladder using a magnet located outside of the bladder (column 9, lines 7 – 10; Figure 8); and
(d) removing the device from the opening of the urinary bladder when the bladder is to be voided (column 8, lines 61 – 66; Figure 7).
Yachia does not teach the wall of the balloon having at least one permanently formed recess, there being a valve positioned in the at least one permanently formed recess of the wall of the balloon and being spaced apart from an exterior surface of the balloon, (b) a central core located in the lumen of the balloon having an end adjacent to the valve, the central core comprising a wall enclosing a central channel and there being one or more openings in the wall of the central channel.
However, Connors discloses “Method and system for treating a patient using a compressible, pressure-attenuating device” (abstract) and teaches a wall (see annotated Connors’ Figure 99(a) below) of a balloon (“Cell 1711” column 61 lines 14 – 15; see annotated Connors’ Figure 99(a) below) having at least one permanently formed recess (see annotated Connors’ Figure 99(a) below), there being a valve (“valve 1713” column 61 line 13; Figures 99(a) - 100) positioned in the at least one permanently formed recess (see annotated Connors’ Figure 99(a) below) of the wall of the balloon (1711) and being spaced apart from an exterior surface (see annotated Connors’ Figure 99(a) below) of the balloon (1711) (see annotated Connors’ Figure 99(a) below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yachia such that the wall of the balloon having at least one permanently formed recess, there being a valve positioned in the at least one permanently formed recess of the wall of the balloon and being spaced apart from an exterior surface of the balloon, as taught by Connors, for the benefit of preventing scraping or injuries from the device/valve to the patient.
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The modified invention of Yachia and Connors does not teach (b) a central core located in the lumen of the balloon having an end adjacent to the valve, the central core comprising a wall enclosing a central channel and there being one or more openings in the wall of the central channel.
However, Gardner discloses a “balloon catheter having an elongated catheter shaft defining a fluid drainage lumen and a balloon inflation lumen” (abstract) and teaches a central core (“catheter shaft 20”, [0029]) located in the lumen of the balloon having an end adjacent to the valve ([0029]), the central core (20) comprising a wall enclosing a central channel and there being one or more openings (“balloon inflation port 42”, Figures 1 – 4, [0027], [0031]) in the wall of the central channel ([0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yachia and Connors such that a central core located in the lumen of the balloon having an end adjacent to the valve, the central core comprising a wall enclosing a central channel and there being one or more openings in the wall of the central channel, as taught by Gardner, for the benefit of preventing the release of fluid back through the inflation connector and using the valves to control the fluid (Gardner: [0031]).
Regarding claim 20, Yachia, Connors and Gardner teaches all limitations of claim 19. Yachia teaches the fluid is selected from a biocompatible fluid, air, water, saline or an oil (column 7, lines 54 – 57).
Regarding claim 21, Yachia, Connors and Gardner teaches all limitations of claim 19. Yachia teaches the inflated balloon has a specific gravity that is less than the specific gravity of urine (“the balloon upon expansion has a specific gravity less than or equal to that of urine”, claim 1).
Regarding claim 22, Yachia, Connors and Gardner teach all limitations of claim 19. Yachia teaches the inflated balloon has a specific gravity that is greater than or equal (“the balloon upon expansion has a specific gravity less than or equal to that of urine”, claim 1) to the specific gravity of urine.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yachia in view of Gardner, as applied in claim 19, in view of Pretorius (US 6786861 B1).
Regarding claim 23, Yachia, Connors and Gardner teach all limitations of claim 19. Yachia does not teach the wall of the balloon is not taut when the balloon is filled.
However, Pretorius discloses “a sling for urinary incontinence and to a method of treating urinary incontinence” (column 1, lines 4 - 5) and teaches the wall of the balloon (“balloon 14”, column 5, lines 4) is not taut when the balloon is filled to less than a maximum if the balloon (column 5, lines 1 - 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Yachia, Connors and Gardner such that the wall of the balloon is not taut when the balloon is filled, as taught by Pretorius, for the benefit of having the adjustability for various sizes due to different patients’ size bladder.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 – 7 and 9 – 23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See rejection above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Richardson et al (US 20040044307 A1) discloses a “urinary catheter of the type which is retained in the urethra by means of a locating balloon also includes an inflatable valve” (abstract).
Connors et al (US 20170079761 A1) discloses an “inflated implant, such as an attenuation device” (abstract).
Yachia et al (US 10631966 B2; filed 2016-08-09) discloses a “a system treating a weak or leaking urinary or other sphincter” (abstract).
Holzer (US 20020151923 A1; filed 2001-04-13) discloses a “device and a method for modulating urination in patients having an obstructed urinary bladder outlet”.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE T TRAN whose telephone number is (703)756-4677. The examiner can normally be reached Monday - Friday from 8:30 am - 5:00 pm.
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/JULIE THI TRAN/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791