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 .
Status of Claims/Election/Restrictions
As directed by the amendment filed on 5 August 2024: claim(s) 1 have been amended, claim(s) 2-20 have been added. Thus, claims 1-20 are presently pending.
Applicant’s election without traverse of Species I (FIGs. 3A-3B) in the reply filed on 23 January 2026 is acknowledged.
Claims 17-24 & 26-27 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim.
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.
Claim(s) 1, 4-5, and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Den Heuvel (US 20080287894 A1).
Regarding Claim 1, Van Den Heuvel discloses a fluid collection device ("urine collection device"; see Abstract), comprising:
a fluid impermeable barrier ("external layer 2 is an impermeable conformable material" [0040]; FIG. 1) having a distal end region, a proximal end region, a front side, and a back side (see FIGs. 1-4), the fluid impermeable barrier defining an opening on the front side ("hole in the external layer 2" [0044]; FIGs. 3-4), one or more apertures on the back side spaced from the opening and positioned between the distal end region and the proximal end region (see Annotated FIG. 3), and a chamber within the fluid collection device (the volume of space defined by "external layer 2 that partially surrounds filling material 3" [0038]; FIG. 3),
wherein the fluid impermeable barrier tapers between the front side and the back side forming a proximal edge at the proximal end region and a distal edge at the distal end region where the front side and the back side meet (see Annotated FIG. 3); and
a fluid permeable body ("filling material 3" [0038]) positioned within the chamber and extending across at least a portion of the opening and the one or more apertures (see FIGs. 3-4).
Annotated FIG. 3
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Regarding Claim 4, Van Den Heuvel discloses the fluid impermeable barrier is contoured to protrude or arc relative to the proximal edge and the distal edge (see FIG. 3).
Regarding Claim 5, Van Den Heuvel discloses the one or more apertures include one aperture positioned on the back side of the fluid impermeable barrier between the first end region and the second end region (see Annotated FIG. 3); and a conduit extending through the one aperture into the chamber ("urine outlet tube 1 enters the pad at its upper (front) end and extends longitudinally along the full length of the pad" [0042]; FIG. 3).
Regarding Claim 7, Van Den Heuvel discloses the conduit extends through the one aperture into the chamber and to the second end region ("open end of the urine outlet tube 1 fits within the tapered end 4 of the pad" [0042]; FIG. 3).
Claim Rejections - 35 USC § 103
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) 2-3, 6, 9-10, 25, and 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Den Heuvel in view of Sanchez et al. (US 20170266031 A1).
Regarding Claims 2 & 28, Van Den Heuvel fails to specify the fluid permeable body is contoured to protrude or arc through the opening relative to the proximal edge and the distal edge. However, Sanchez teaches “a system suitable for collecting and transporting urine away from the body” (see Abstract) wherein, the fluid permeable body is contoured to protrude or arc through the opening relative to the proximal edge and the distal edge ("slight protrusion of the permeable support 2640 outside the casing 2604 via the elongated opening 2604A" [0169]; FIG. 46). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Van Den Heuvel to incorporate the teachings of Sanchez to suitably allow the collection device to “maintain contact with the user during a urination event" ([0169]).
Regarding Claims 3 & 29, Van Den Heuvel discloses the front side of the fluid impermeable barrier includes a substantially oval periphery ("oval" [0052]; FIG. 2) with the front side being substantially planar (see FIG. 3) and extending inward from the substantially oval periphery to the opening defined by the front side (see FIG. 2).
Regarding Claim 6, Van Den Heuvel fails to specify the one aperture is positioned approximately halfway between the first end region and the second end region. However, Sanchez teaches the one aperture is positioned approximately halfway between the first end region and the second end region ("opening 2580 can be disposed at other position(s) along the impermeable backing" [0163]). Therefore, it would have been obvious to modify Van Den Heuvel’s device “to ensure effective transfer of voided urine” ([0174]).
Regarding Claim 9, Van Den Heuvel fails to specify a support member including a shape memory material extending longitudinally at least partially through the fluid collection device. However, Sanchez teaches a support member including a shape memory material ("shape-defining or shape-retaining element 151" [0084]) extending longitudinally at least partially through the fluid collection device ([0084] & [0158]; FIGs. 1 & 42). Therefore, it would have been obvious to modify Van Den Heuvel’s device to suitably provide support and prevent the collapsing of the device while conforming “to differently shaped and/or sized users to ensure effective and secure placement of the assembly” ([0138]).
Regarding Claim 10, Van Den Heuvel fails to specify the support member extends from the proximal end region at least about two-thirds of a distance to the distal end region such that the one aperture is positioned between a proximal end of the support member and a distal end of the support member. However, Sanchez teaches the support member extends from the proximal end region at least about two-thirds of a distance to the distal end region such that the one aperture is positioned between a proximal end of the support member and a distal end of the support member ("extends from the reservoir and through at least a portion of a permeable support, similar to, for example, the tube 1621 shown with respect to FIGS. 32 and 33" [0155]; FIGs. 32-33). Therefore, it would have been obvious to modify Van Den Heuvel’s device to suitably provide support and prevent the collapsing of the device while conforming “to differently shaped and/or sized users to ensure effective and secure placement of the assembly” ([0138]).
Regarding Claim 25, Van Den Heuvel discloses a fluid collection system, comprising: a fluid collection device ("urine collection device"; see Abstract) including:
a fluid impermeable barrier ("external layer 2 is an impermeable conformable material" [0040]; FIG. 1) having a first end region, a second end region, a front side, and a back side (see FIGs. 1-4), the fluid impermeable barrier defining an opening on the front side ("hole in the external layer 2" [0044]; FIGs. 3-4), an aperture on the back side distal to the opening and positioned between the first end region and the second end region (see Annotated FIG. 3), and a chamber within the fluid collection device (the volume of space defined by "external layer 2 that partially surrounds filling material 3" [0038]; FIG. 3),
wherein the fluid impermeable barrier tapers between the front side and the back side forming a proximal edge at the proximal end region and a distal edge at the distal end region where the front side and the back side meet (see Annotated FIG. 3); and
a fluid permeable body ("filling material 3" [0038]) positioned within the chamber and extending across at least a portion of the opening (see FIGs. 3-4);
a conduit extending through the aperture into the chamber ("urine outlet tube 1 enters the pad at its upper (front) end and extends longitudinally along the full length of the pad" [0042]; FIG. 3) but fails to specify a vacuum source in fluid communication with the conduit and configured to draw urine from the chamber and through the conduit.
However, Sanchez teaches a vacuum source ("vacuum source 170" [0072]; FIG. 1) in fluid communication with the conduit and configured to draw urine from the chamber and through the conduit ("urine is simultaneously removed via, for example, gravity and/or a pump, such as the vacuum source 170" [0076]). Therefore, it would have been obvious to modify Van Den Heuvel’s device to suitably increase urine removal rate to “ensure effective transfer of voided urine” ([0174]).
Regarding Claim 30, Van Den Heuvel discloses the fluid impermeable barrier is contoured to protrude or arc relative to the proximal edge and the distal edge (see FIG. 3).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Den Heuvel in view of Kuntz (US 4747166 A).
Regarding Claim 8, Van Den Heuvel fails to specify the conduit includes a plurality of openings positioned in the chamber and in fluid communication with the chamber. However, Kuntz teaches “a urine aspiration system for the management of urinary incontinence comprising” (Abstract) wherein the conduit includes a plurality of openings positioned in the chamber and in fluid communication with the chamber ("extended perforated end portion 30 which may be inserted within pad 12a to occupy substantially the entire extent of the hollow bore 22a of such pad" col. 3 ln. 62-64; FIG. 2). Therefore, it would have been obvious to modify Van Den Heuvel’s device so that urine may be quickly removed and thus minimizing patient discomfort (col. 2 ln. 3-17).
Allowable Subject Matter
Claims 11-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the cited references fails to specify a fluid impermeable collection bag secured to the fluid impermeable barrier and covering at least a portion of the back side of the fluid impermeable barrier, the fluid impermeable collection bag defining an interior region in fluid communication with the chamber of the fluid impermeable barrier through the one or more apertures in the back side of the fluid impermeable barrier. While Wilcox et al. (US 20120245547 A1) teaches an impermeable bag (“shell” [0008]; FIGs. 1-2) worn to “help prevent soiling of clothing with discharged urine, provide comfort to the male genitalia, allow sufficient freedom of movement to permit normal daily activities, and help separate the genitalia from discharged urine” ([0007]), the “shell” is not “defining an interior region in fluid communication with the chamber of the fluid impermeable barrier through the one or more apertures in the back side of the fluid impermeable barrier”. The remaining claims are at least allowable due to their dependency upon an allowable claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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, Rebecca E. 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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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781