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 .
Claim Interpretation
Claim 1 calls for “… a sump … the fluid permeable support configured to completely occupy the chamber and the sump…”
The specification describes a sump and also two variants where the support either occupies the sump (¶ [0050], In an embodiment, the sump 114 may be occupied by the fluid permeable support 102 and/or the fluid permeable membrane 104); or
where the support does not occupy the sump (¶ [0052] In an embodiment, not shown, the fluid permeable support 102 and the fluid permeable membrane 104 do not completely occupy the sump 114. In other words, the sump 114 may include a substantially unoccupied reservoir).
The specification further describes that the sump extends near the chamber’s expected gravimetric low point (¶ [0051], The hydrogen bonding … decreases the need to position the inlet 136 of the conduit 116 at or near the expected gravimetric low point of the chamber 108).
Occupying the sump with the permeable support raises the question of how to define the sump. Claim 1 specifies that the support completely occupies the sump, which implies that the sump is defined as a region or extension of the chamber near its expected gravimetric low point, rather than a void, cavity or empty space.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 13, 14, 16, 17, 19, 20 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Van Den Heuvel; Eleanor et al. (US 20080287894 A1) in view of Lawrence; W. Thompson et al. (US 5678564 A) in view of Mahlmann; Lee A. (US 6068477 A).
Regarding claim 1, Van Den Heuvel discloses a fluid collection assembly (¶ [0001], a pad for use with a urine collection device; ¶ [0034] FIG. 1 shows an isometric view of a pad according to an embodiment of the invention);
comprising: a fluid impermeable barrier defining at least a chamber, at least one opening (¶ [0038] Referring to FIGS. 1 and 2, a preferred pad comprises an external layer 2; ¶ [0040] The external layer 2 is an impermeable conformable material such as flexible plastic or expanded polystyrene);
a fluid outlet (annotated Fig. 3 shows a fluid outlet where the outlet tube 1 exits the external impervious layer 2); and
PNG
media_image1.png
406
713
media_image1.png
Greyscale
a sump (annotated Fig. 3 shows a sump near the inlet of outlet tube 1);
the fluid impermeable barrier including a distal end region and a proximal end region (Figs. 1-4, impervious layer 2 extends in a longitudinal direction between distal and proximal ends);
a fluid permeable support (¶ [0038], The filling material 3 comprises a single layer of open low-density material that does not appreciably resist the flow of urine nor retain urine, and thereby allows urine to pass rapidly though);
having an absorbency of 15 wt% or less of the dry weight of the fluid permeable support (¶ [0039] The filling material 3 resists crushing but is still comfortable to wear. The density of the filling material 3 in this embodiment is 0.03-0.1 g/cm.sup.3. The porosity of the filling material 3 is in this embodiment between 50% and 99% of the volume of the pad; ¶ [0050] The filling material 3 can be any suitable material that gives no effective resistance to a flow of urine. In other words, the urine should pass through the filling material as though it were not present);
the fluid permeable support configured to completely occupy the chamber and the sump (Figs. 3, 4, filling material 3 substantially fills the entire space inside external layer 2);
a conduit connected to the fluid outlet, the conduit including an inlet disposed in or adjacent to the sump (¶ [0042], The open end of the urine outlet tube 1 fits within the tapered end 4 of the pad).
Van Den Heuvel does not extend a fluid permeable membrane across the opening. Lawrence discloses a fluid collection assembly (col. 1, lines 5-10, a female external catheter providing improved urine removal; col. 5, lines 5-10, interface device 10);
comprising: a fluid impermeable barrier defining at least a chamber (col. 5, lines 45-50, plastic shell 28 which is preferably made of a flexible material that permits the device to conform to minor differences in each patient's physique);
at least one opening (col. 5, lines 25-30, The body contact surface 17 is provided with a urine opening which may be generally rectangular, oval, or obround, and of a size and location so as to be aligned with the urethra; cols. 6-7, lines 65-5, As seen in FIG. 2b there is an impervious cover 23 with an opening 20 for liquid entry); and
a fluid permeable membrane disposed on at least a portion of the fluid permeable support, the fluid permeable membrane extending across the at least one opening (col. 5, lines 30-45, The body contact surface 17 is provided with a urine opening … The interface device is provided with a coverstock material 21 over body contact surface 17).
Lawrence repels moisture from the wearer’s skin in order to reduce irritation (col. 5, lines 40-45, The coverstock is capable of repelling moisture but retaining the capacity to "breathe" so that there is a reduced risk of irritation to the skin). One would be motivated to modify Van Den Heuvel with Lawrence’s fluid permeable membrane to minimize the user’s irritation. Therefore, it would have been obvious to modify Van Den Heuvel with Lawrence’s membrane in order to avoid irritating the user by repelling moisture from their skin.
Van Den Heuvel and Lawrence are silent regarding the collection assembly’s thickness. Mahlmann discloses a dental aspirator comprising a fluid collection assembly (col. 1, lines 10-15; col. 2, lines 55-65, aspirator 10);
comprising: a fluid permeable support (col. 2, lines 60-65, an elongated hollow plastic tube 12 having substantially its entire external surface 13 covered by a layer of soft polymer foam 14); and
a conduit (col. 2, lines 60-65, The only portion of the elongate tubular element 12 which is exposed is a connector end section 16; col. 3, lines 15-20, The hollow plastic tubing 12 can have an inside diameter ranging from about 3 mm to whatever size meets the need);
wherein the fluid permeable support exhibits a thickness less than 3 mm (col. 2, lines 15-20, The foam 14 covering the hollow plastic tubing can range in thickness from about 1 mm to whatever thickness is needed to meet the cushioned effect that is desired. The normal foam thickness range would be from about 1 mm to about 3 mm).
Mahlmann demonstrates a workable thickness range for a porous foam support, and shows that a thickness between about 1-3 mm is adequate for cushioning a drain device and transmitting fluids. One would be motivated to modify Van Den Heuvel and Lawrence with Mahlmann’s permeable support thickness to construct Van Den Heuvel’s device with suitable dimensions, since Van Den Heuvel also relies on a foam layer to cushion the device and to transmit fluids. Therefore, it would have been obvious to modify Van Den Heuvel and Lawrence with Mahlmann’s permeable support thickness in order to construct the permeable support with suitable dimensions that can cushion the device and transmit fluid.
Regarding claim 13, Van Den Heuvel does not explicitly disclose that the support has a rectangular cross-sectional shape. Lawrence discloses a fluid permeable support having a generally rectangular cross-sectional shape (Fig. 2a, fibrous foam or other filler material 24 has a generally rectangular cross-sectional shape).
Lawrence configures a permeable support with another suitable shape that can be manufactured easily. One would be motivated to modify Van Den Heuvel with Lawrence’s generally rectangular cross-section to experiment with other known shapes, and since Van Den Heuvel suggests to alter the assembly’s features (¶ [0052]-[0055]). Therefore, it would have been obvious to modify Van Den Heuvel with Lawrence’s generally rectangular cross-section in order to experiment with other known shapes.
Regarding claims 14, 16, 17, 19 and 20, Van Den Heuvel discloses an assembly wherein the fluid permeable support exhibits a generally trapezoidal cross-sectional shape (Figs. 3, 4, filling material 3 has upper corners with acute angles and lower corners with obtuse angles, therefore the filling material 3 has a generally trapezoidal cross-sectional shape);
wherein the fluid outlet is spaced from the distal end region and the proximal end region of the fluid impermeable barrier (Figs. 3, 4, urine outlet tube 1 is spaced from the external layer 2’s upper corners and therefore spaced from its distal and proximal ends);
wherein the sump is spaced from the distal end region and the proximal end region of the fluid impermeable barrier (Figs. 3, 4, urine outlet tube 1’s inlet is spaced from the external layer 2’s upper corners and therefore spaced from its distal and proximal ends);
wherein at least one of the fluid permeable support or the fluid permeable membrane define a bore that is not generally parallel to a longitudinal axis of the fluid collection assembly, the conduit extending in the bore from the sump to the fluid outlet (Figs. 3, 4, urine outlet tube 1 extends through filling material 3 along a curved path);
wherein the conduit extends from the fluid outlet along a portion of a back surface of the fluid impermeable barrier or the conduit extends within a portion of the fluid impermeable barrier that forms the back surface, the back surface of the fluid impermeable barrier is opposite the opening (Figs. 3, 4, urine outlet tube 1 extends generally in contact with external layer 2’s bottom layer).
Claims 3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Van Den Heuvel, Lawrence and Mahlmann in view of Tazoe, Wataru et al. (US 20040236292 A1).
Regarding claims 3 and 5-7, Van Den Heuvel, Lawrence and Mahlmann lack a plurality of branches. Tazoe discloses an automatic urine disposal device (¶ [0001], [0008]], [0020] FIGS. 1 through 4 show an embodiment of the present invention);
comprising a fluid collection assembly that includes a plurality of branches extending from at least one common area, and wherein the plurality of branches form a gap therebetween; wherein the plurality of branches and the at least one common area form a generally V- like shape or a generally Y- like shape; wherein the at least one common area includes a plurality of common areas and at least one of the plurality of branches extends between at least two of the plurality of common areas (¶ [0063], FIGS. 11 and 12 … In the perforated urine drainage tube unit 115, one end of three perforated urine drainage tubes 125 are connected with a common tube 126 … The joint 113, which is installed at the end of the urine drainage tube 11 la, is connected to one end of the urine drainage tube lib).
Tazoe distributes negative pressure more evenly through a collection assembly. One would be motivated to modify Van Den Heuvel, Lawrence and Mahlmann with Tazoe’s plural branches to more rapidly remove fluid from the permeable support as called for by Van Den Heuvel (¶ [0050], In other words, the urine should pass through the filling material as though it were not present). Therefore, it would have been obvious to modify Van Den Heuvel, Lawrence and Mahlmann with Tazoe’s plural branches in order to accelerate the fluid movement towards the conduit.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Van Den Heuvel, Lawrence and Mahlmann in view of Caldwell; J. Michael et al. (US 6083602 A).
Regarding claim 25, Van Den Heuvel, Lawrence and Mahlmann lack an anti-clotting protein. Caldwell discloses a fluid impermeable barrier (col. 1, lines 30-35, barrier fabrics that are substantially impermeable to water; col. 7, lines 15-30; col. 52, lines 25-35, FIG. 9, the disposable or non-disposable, breathable brief 50 consists of four parts. an outer shell or pant 55 … the outer shell or pant 55 is a barrier web made according to the present invention and is breathable but void resistant);
wherein the fluid impermeable barrier includes an anti-clotting protein disposed thereon (cols. 52-53, lines 65-5, Other agents that can incorporated into the barrier webs of the present invention are acid mucopolysaccharides including, but are not limited to heparin, heparan sulfate, heparinoids, dermatan sulfate, pentosan polysulfate, chondroitin sulfate, hyaluronic acid, cellulose, agarose, chitin, dextran, and carrageenin).
Caldwell applies heparin or related compounds as agents that reduce the spread of pathogens (col. 53, lines 10-15, The fabric is especially suited as a barrier to prevent or control the spread of infectious microorganisms, especially in career apparel for health care workers). One would be motivated to modify Van Den Heuvel, Lawrence and Mahlmann with Caldwell’s anti-clotting protein to prevent pathogens from adhering to the impermeable barrier, and thereby reduce the chance of infections. Therefore, it would have been obvious to modify Van Den Heuvel, Lawrence and Mahlmann with Caldwell’s anti-clotting protein in order to reduce the risk of spreading an infection.
Claim 27 rejected under 35 U.S.C. 103 as being unpatentable over Van Den Heuvel, Lawrence and Mahlmann with incorporation of Wolff, Heinz Siegfried et al. (US 20020087131 A1).
Regarding claim 27, Van Den Heuvel incorporates by Wolff reference (¶ [0005] WO 00/57784, the entire contents of which are incorporated herein by reference, discloses a urine collection device … a storage container).
Wolff further discloses a fluid storage container; and a vacuum source (¶ [0022] (1) A rigid container which is connected by a tube to a small pump and pressure switch or vacuum transducer and switch; ¶ [0027] The large capacity devices of FIGS. 1a, 1b, 1c, and 2a, 2b preferably have a 1.5-2.5 liter capacity rigid storage container 1; ¶ [0028] The volume within the container is connected to the small diaphragm pump 4, via an outlet 20);
wherein the chamber of the fluid collection assembly is in fluid communication with the fluid storage container and the vacuum source via one or more conduits (¶ [0029] Urine is drawn into the container through a tube 6 which goes into the top of the lid 11).
Allowable Subject Matter
Claims 4, 8-12 and 26 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.
Response to Arguments
The objections to the drawings and ¶ [0031], [0049] in the specification for a missing element 112 are withdrawn in view of the amended ¶ [0031], [0049] filed 27 July 2026.
The rejection of claim 1 under 35 USC § 112(a) is withdrawn in view of the amendments filed 27 July 2026.
Applicant’s arguments filed 27 July 2026 regarding the rejection of claims 1, 3, 5-7, 13-14, 16-17, 19-20, 25 and 27 as amended, under 35 USC § 103 over Van Den Heuvel, Lawrence, Tazoe, Caldwell and Wolff, have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 103 over Van Den Heuvel, Lawrence, Mahlmann, Tazoe, Caldwell and Wolff (see above).
Applicant submits that the PTO has not addressed, let alone established, that the thickness of the fluid permeable support is a result-effective variable subject to routine optimization (remarks p. 8). Applicant asserts that accordingly, the PTO has not demonstrated that the cited references teach or suggest "the fluid permeable support exhibits a thickness less than 3 mm," as recited in currently amended independent claim 1 (remarks p. 9). Examiner responds that Van Den Heuvel, Lawrence and Mahlmann are cited in the new grounds of rejection as teaching all features of amended claim 1. Mahlmann explicitly discloses a fluid permeable support having a thickness between about 1-3 mm (col. 3, lines 20-25).
Applicant contends that Tazoe does not disclose a fluid collection assembly that includes a plurality of branches forming a gap therebetween (remarks p. 9). Applicant reasons that Tazoe therefore discloses neither a branched fluid collection assembly nor a gap formed between branches of such an assembly (remarks p. 9). Examiner replies that claim 3 describes the branches in broad terms, and does not require each branch to include its own permeable support, permeable membrane and conduit. Tazoe’s branches each includes at least a perforated conduit that is configured to collect fluid (¶ [0063], In the perforated urine drainage tube unit 115, one end of three perforated urine drainage tubes 125 are connected with a common tube 126). Tazoe shows at least two gaps that extend between the three drainage tubes 125 (Fig. 11).
PNG
media_image2.png
429
778
media_image2.png
Greyscale
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 27 July 2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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:
Tel 571-272-2590
Fax 571-273-2590
Email Adam.Marcetich@uspto.gov
The Examiner can be reached 8am-4pm Mon-Fri.
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 is assigned is 571-273-8300.
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.
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.
/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights