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 .
Election/Restrictions
Applicant’s election without traverse of Species II in the reply filed on 3/18/2026 is acknowledged.
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Den Heuvel (US 20080287894 A1) in view of Tsai et al. (US 20100211032 A1).
Regarding claim 1, Van Den Heuvel discloses a urine collection device, comprising: a fluid impermeable layer (2) including a first end region (C, annotated fig. 2) having a first width and a second end region (D, annotated fig. 2) having a second width that is at least about 2 times greater than the first width of the first end region such that the fluid impermeable layer narrows between the second end region and the first end region (see fig. 2); one or more fluid permeable layers (3, para. [0038]) secured to the fluid impermeable layer, at least one fluid permeable layer of the one or more fluid permeable layers positioned to be at least proximate to a urethra of a subject when the urine collection device is secured to the subject (para. [0040]); and a conduit (1) positioned between at least a portion of the one or more fluid permeable layers and the fluid impermeable layer (fig. 3, para. [0044]), the conduit extending from an inlet at least proximate to the first end region of the fluid impermeable layer to the second end region of the fluid impermeable layer (fig. 3).
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However, Van Den Heuvel fails to disclose wherein the conduit is configured to couple to a vacuum source effective to pull urine discharged into the urine collection device into the inlet and through the conduit for removal from the urine collection device
Tsai teaches a similar device in the same field of endeavor wherein the conduit (16) is configured to couple to a vacuum source effective to pull urine discharged into the urine collection device into the inlet and through the conduit for removal from the urine collection device (para. [0034, 0036, 0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Van Den Heuvel and incorporate the vacuum suctioning of Tsai to remove the collected urine from the device, yielding predictable results—siphoning of fluid through a conduit.
Regarding claim 2, the combination of Van Den Heuvel and Tsai discloses the device of claim 1. Van Den Heuvel further discloses wherein at least a portion of the at least one fluid permeable layer of the one or more fluid permeable layers positioned to be at least proximate to the urethra of the subject forms a substantially concave surface on the urine collection device (fig. 3, para. [0040]).
Regarding claim 3, the combination of Van Den Heuvel and Tsai discloses the device of claim 2. Van Den Heuvel further discloses wherein the at least a portion of the at least one fluid permeable layer (3) of the one or more fluid permeable layers includes a wicking material (“low-density material that does not appreciably resist the flow of urine nor retain urine, and thereby allows urine to pass rapidly through,” para. [0038]) forming the substantially concave surface positioned to be at least proximate to the urethra of the subject (fig. 3).
Regarding claim 4, the combination of Van Den Heuvel and Tsai discloses the device of claim 1. Van Den Heuvel further discloses further comprising a reservoir (4) of void space at the first end region of the fluid impermeable layer and configured to hold at least some of the urine discharged into the urine collection device, the inlet of the conduit being positioned at least proximate to the reservoir (fig. 3, para. [0044, 0048]).
Regarding claim 5, the combination of Van Den Heuvel and Tsai discloses the device of claim 4. Van Den Heuvel further discloses wherein the one or more fluid permeable layers (3) include at least a wicking material configured to direct the urine towards the reservoir and the inlet of the conduit (“low-density material that does not appreciably resist the flow of urine nor retain urine, and thereby allows urine to pass rapidly through,” para. [0038]).
Regarding claim 6, the combination of Van Den Heuvel and Tsai discloses the device of claim 1. Van Den Heuvel further discloses wherein the fluid impermeable layer (2) defines an aperture (E, annotated fig. 3) at the second end region (D) and the conduit extends through the aperture (fig. 3).
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Regarding claim 7, the combination of Van Den Heuvel and Tsai discloses the device of claim 1. Van Den Heuvel further discloses wherein the fluid impermeable layer includes a fluid impermeable film (“impermeable conformable material such as flexible plastic,” para. [0040]) and at least one permeable layer (3) of the one or more permeable layers includes a wicking material (“low-density material that does not appreciably resist the flow of urine nor retain urine, and thereby allows urine to pass rapidly through,” para. [0038]).
Regarding claim 8, the combination of Van Den Heuvel and Tsai discloses the device of claim 7. Van Den Heuvel further discloses wherein the wicking material (3) forms at least a portion of a front side (“front” as in the top side closer to the user’s urethra) of the urine collection device and the fluid impermeable film forms a rear side (“rear” as in the bottom side farther from the urethra) of the urine collection device (fig. 3).
Regarding claim 9, Van Den Heuvel discloses a urine collection device, comprising: a first region (G) of fluid impermeable material (2) at a first end region (C) of the urine collection device, the first end region (C) having a first width (annotated fig. 2) and the first region of fluid impermeable material defining a reservoir of void space (4) in the first end region of the urine collection device; a second region (H) of fluid impermeable material at a second end (D) region of the urine collection device and narrowing in width as the second region of fluid impermeable material extends to the first end region (fig. 2), the second end region having a second width that is at least about 2 times greater than the first end region (fig. 2); a fluid permeable material (3) extending at least partially between the first end region and the second end region (fig. 3), at least some of the fluid permeable material positioned to be at least proximate to a urethra of a subject when the urine collection device is secured to the subject (para. [0040]); and a conduit (1) having an inlet positioned at least proximate to reservoir (4) of void space in the first region of fluid impermeable material (fig. 3), the conduit (1) extending from the inlet between at least some of the fluid permeable material and the second region of fluid impermeable material and to the second end region of the urine collection device (fig. 3).
However, Van Den Heuvel fails to disclose wherein the conduit is configured to couple to a vacuum source effective to pull urine discharged into the urine collection device into the inlet and through the conduit for removal from the urine collection device
Tsai teaches a similar device in the same field of endeavor wherein the conduit (16) is configured to couple to a vacuum source effective to pull urine discharged into the urine collection device into the inlet and through the conduit for removal from the urine collection device (para. [0034, 0036, 0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Van Den Heuvel and incorporate the vacuum suctioning of Tsai to remove the collected urine from the device, yielding predictable results—siphoning of fluid through a conduit.
Regarding claim 10, the combination of Van Den Heuvel and Tsai discloses the device of claim 9. Van Den Heuvel further discloses wherein the at least some of the fluid permeable material (3) positioned to be at least proximate to the urethra of the subject forms a substantially concave surface on the urine collection device (fig. 3, para. [0040]).
Regarding claim 11, the combination of Van Den Heuvel and Tsai discloses the device of claim 10. Van Den Heuvel further discloses wherein the at least some of the at the fluid permeable material includes a wicking material (“low-density material that does not appreciably resist the flow of urine nor retain urine, and thereby allows urine to pass rapidly through,” para. [0038]) forming the substantially concave surface positioned to be at least proximate to the urethra of the subject (para. [0040], fig. 3).
Regarding claim 12, the combination of Van Den Heuvel and Tsai discloses the device of claim 9. Van Den Heuvel further discloses wherein the fluid permeable material includes at least a wicking material (“low-density material that does not appreciably resist the flow of urine nor retain urine, and thereby allows urine to pass rapidly through,” para. [0038]) configured to direct the urine towards the reservoir and the inlet of the conduit.
Regarding claim 13, the combination of Van Den Heuvel and Tsai discloses the device of claim 12. Van Den Heuvel further discloses wherein the second region of fluid impermeable material includes a fluid impermeable film (“impermeable conformable material such as flexible plastic,” para. [0040).
Regarding claim 14, the combination of Van Den Heuvel and Tsai discloses the device of claim 13. Van Den Heuvel further discloses wherein the wicking material (3) forms at least a portion of a front side (“front” as in the top side closer to the user’s urethra) of the urine collection device and the fluid impermeable film forms a rear side (“rear” as in the bottom side farther from the urethra) of the urine collection device (fig. 3).
Regarding claim 15, the combination of Van Den Heuvel and Tsai discloses the device of claim 9. Van Den Heuvel further discloses wherein the fluid impermeable layer defines an aperture (E) at the second end region (D) and the conduit extends through the aperture (fig. 3).
Allowable Subject Matter
Claims 16-20 are allowed.
The following is an examiner’s statement of reasons for allowance: there is no art alone or in combination that discloses a urine collection device with a first member extending longitudinally between a fluid permeable material and a fluid impermeable layer; a second member extending longitudinally between the fluid permeable material and the impermeable layer; and a connector secured to the first member and the second member, the first member and the second member forming a V-shaped configuration in the urine collection device when secured to the connector. The closest prior art is discussed below.
Joh (US 20190374373 A1) discloses a wearable urinary collection apparatus (fig. 2A) that shows a V-shaped configuration of two diverging members at the inner thighs. However, the claim requires a connector that is secured to the first and second members for form that V-shaped configuration and the structure of Joh is a continuous conduit, not segments joined by a connector. It would not have been obvious to change the structure of Joh to be separate parts joined by a connector without a reference to rely on. Furthermore, altering Joh could introduce potential leaks between the connection points and without art to contribute such a teaching it would not have been obvious. Additionally, Joh is not configured to be connected to a suction system, rather the diverging segments are connected to collecting bags that stay on the body.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 1 April 2026
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