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 I in the reply filed on 10/20/2025 is acknowledged.
Response to Arguments
Applicant’s arguments with respect to claim(s) 02/17/26 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.
The examiner notes that per the previous office action claims 9-22 and 29-33 where withdrawn for consideration for being directed to nonelected species. While some of said claims were withdrawn, claims 14-15, 21-22,30-32 were not and as such said claims should be withdrawn.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7,23-28,34-36 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Austermann WO 2019212951, provided in the previous office action.
Regarding claim 1, Austermann discloses a fluid collection device (abstract) comprising fluid impermeable barrier (Fig. 2A (102)) having and outer surface and inner surface (figure 3, where the outer surface is the most external surface and the inner surface can be seen touching (104)), the inner surface at least partially defining a chamber (para. 0019, (104)), the fluid impermeable barrier also defining an opening extending therethrough (para. 0019, Figures 2A,3 (106)), where the opening is configured to be positioned adjacent to a urethra (para. 0019 fig. 2b), a porous member within the chamber (wicking material (115), see figure 2A, 3, para. 0036), and one or more flanges configured to retain collection device between a patient's legs (para. 0042, flange (140)), the one or more flanges configured to retaining configured to press into the legs of the wearer during use and retain the fluid collection device in the position responsive to the means for retaining pressing into the legs of the wearer (figure 2b, where flanges (140) can be seen pressing on the user’s legs to retain the device, see para. 0042, where the flange contacts the inner thigh and maintains position).
Per the amendments filed 02/17/2026, the examiner notes that Austermann still reads to the claimed limitation. Austermann teaches a first end region (portion with external tubing in figure 2a) and a second end region longitudinally spaced from the first end region (second region is interpreted as the closed end opposite the defined first end region. As they are on opposite ends of the device they are longitudinally separated), one or more flanges configured to retain the device between the users legs (updated above under the same rejection, para. 0042, flanges 140). The examiner notes that per paragraph 0063 of Austermann the flange may be an integral portion of the fluid impermeable barrier. As the fluid impermeable barrier forms the chamber it is interpreted that the flanges at least partially directly define a portion of the chamber.
Regarding claim 2, Austermann discloses the fluid collection device of claim 1 wherein the fluid impermeable barrier is substantially cylindrical (see figures 2a and 3, see also para. 0029).
Regarding claim 3, Austermann discloses the fluid collection device of any of claims 1-2 wherein the porous material (figure 3, (115)) includes: a fluid permeable membrane disposed within the chamber and extending across the opening (figure 3, (118) see para. 0034); and a fluid permeable support (120, para. 0035) disposed within the chamber beneath the fluid permeable membrane (fig. 3).
Regarding claim 4, Austermann discloses the fluid collection device of claim 1 further comprising a conduit(108 in figure 2b, 3) including an inlet (110) and an outlet (112), the inlet being positioned within the fluid collection device and the outlet is configured to be fluidly connected to a fluid storage container (figure 3, para. 0047, where inlet 110 is seen in the chamber and outlet 112 is seen extending out of the device and para. 0036 discloses that the conduit allows for connection of the device to a storage container as seen in figure 1, see also para. 0070 where figure 5 shows the outlet connected to a vacuum source [330] which further connects to a container).
Regarding claim 5, Austermann discloses the fluid collection device of claim 4 wherein: the fluid impermeable barrier and one or more of the fluid permeable membrane or fluid permeable support define a reservoir therebetween (reservoir 122); and the inlet is disposed in the reservoir (where the inlet is in the reservoir per para. 0069).
Regarding claim 6, Austermann discloses the fluid collection device of claim 1, wherein the one or more flanges extend longitudinally along at least a portion of the fluid impermeable barrier proximate to the opening (fig. 2) and extend outwardly (fig. 2) from the fluid impermeable barrier a distance of less than 2 cm (para. 0040, where the flange may extend 1cm away from the device and thus extends less than 2cm)
Regarding claim 7, Austermann discloses the fluid collection device of claim 1 wherein the one or more flanges includes a plurality of flanges in the fluid impermeable barrier (see two flanges provided in figure 2a, para. 0040 discloses where the at least one flange may include 2 or more flanges), wherein the plurality of flanges are at least partially malleable (para. 0041, where the flange is capable of deforming in response to pressure, may be flexible, and may conform to manipulation).
Regarding claim 23, Austermann discloses a fluid collection system, comprising: a fluid storage container configured to hold a fluid (para. 0006, 0019, 0022, figure 1 showing a container (14) in a block diagram); a fluid collection device according to any of claims 1-22 (see rejection of claim 1); a conduit (108 in figure 2b, 3) including an inlet (110) and an outlet (112), the outlet being fluidly coupled to the fluid storage container and the inlet being positioned in the chamber (figure 3, para. 0047, where inlet 110 is seen in the chamber and outlet 112 is seen extending out of the device and para. 0036 discloses that the conduit allows for connection of the device to a storage container as seen in figure 1, see also para. 0070 where figure 5 shows the outlet connected to a vacuum source [330] which further connects to a container).
and a vacuum source fluidly coupled to one or more of the fluid storage container or the fluid collection device via the conduit (para. 0070, figure 1,5, where in figure 5 the outlet (330) is seen connecting to the outlet of the conduit), the vacuum source configured to draw fluid from the fluid collection device via the conduit (para 0028).
Regarding claim 24, Austermann discloses the fluid collection system of claim 23 wherein the vacuum source includes one or more of a vacuum pump, a vacuum line, or a hand pump (various types of vacuum pumps per para. 0028).
Regarding claim 25, Austermann discloses the fluid collection system of claim 23 wherein the fluid storage container includes one or more of a canister or a bag (para. 0026 where the container may include a bag, bottler, cup, or other container.
Regarding claim 26, Austermann discloses a method to collect fluid, the method comprising: positioning a fluid collection device adjacent to a urethra of a wearer (fig. 3a, 10 (1010) para. 0020, 0022) effective to press one or more flanges (140) into legs a wearer and retain the fluid collection device in the position responsive to the one or more flanges pressing into the legs of the wearer (1020, para. 0042-0043, where the flange (means for retaining) is secured to the inner thigh of the user, see also para. 0078); receiving fluid from the urethra into the fluid collection device (1030); and removing the fluid from the fluid collection device via a conduit fluidly connected thereto (para. 0006, where the vacuum removes fluid from the collection device, where conduit (108) is connected to a container and the vacuum (para. 0043).
Per the amendments filed 02/17/2026, the examiner notes that Austermann still reads to the claimed limitation. Austermann teaches a first end region (potion with external tubing in figure 2a) and a second end region longitudinally spaced from the first end region (second region is interpreted as the closed end opposite the defined first end region. As they are on opposite ends of the device they are longitudinally separated), one or more flanges configured to retain the device between the users legs (updated above under the same rejection, para. 0042, flanges 140). The examiner notes that per paragraph 0063 of Austermann the flange may be an integral portion of the fluid impermeable barrier. As the fluid impermeable barrier forms the chamber it is interpreted that the flanges at least partially directly define a portion of the chamber. Austermann further discloses the device including a fluid impermeable barrier defining a chamber (102) para. 0019, (104)), and an opening extending therethrough (para. 0019, Figures 2A,3 (106).
Regarding claim 27, Austermann discloses the method of claim 26 wherein the fluid collection device includes: a fluid impermeable barrier (Fig. 2A (102)) having an outer surface and an inner surface (figure 3, where the outer surface is the most external surface and the inner surface can be seen touching (104)), the inner surface at least partially defining the chamber(para. 0019, (104)), the opening configured to be positioned adjacent to a urethra(para. 0019 fig. 2b); and a porous material at least partially disposed in the chamber (wicking material (115), see figure 2A, 3, para. 0036).
Regarding claim 28, Austermann discloses the method of claim 27 wherein: the one or more flanges includes a plurality of flanges (see two flanges provided in figure 2a, para. 0040 discloses where the at least one flange may include 2 or more flanges), in the fluid impermeable barrier, wherein the plurality of flanges are at least partially malleable (para. 0041, where the flange is capable of deforming in response to pressure, may be flexible, and may conform to manipulation); and positioning a fluid collection device adjacent to the urethra of a wearer includes placing at least some of the plurality of flanges in contact with the wearer (para. 0042-0043, where the flange (means for retaining) is secured to the inner thigh of the user, see also para. 0078).
Regarding claim 34, Austermann discloses the method of any of claims 27 wherein removing the fluid from the fluid collection device includes applying suction in fluid collection device with a vacuum source (para. 0028) fluidly connected to the conduit effective to suction the fluid from the fluid collection device via the conduit (para. 0036).
Regarding claim 35, Austermann discloses the method of claim 34 wherein the vacuum source is spaced from the fluid collection device (figure 1, para. 0022, where the vacuum source is seen to be separated from the device by the container and conduits), and applying suction with the vacuum source includes activating the vacuum source (para. 0028 and 00102).
Regarding claim 36, Austermann discloses the method of claim 26, wherein the fluid collection device include the fluid collection device of any of claims 1-22. The examiner notes that the rejection of claim 26 is within the same disclosure of the prior art device of Austermann, and it is therefore understood that the method of claim 26 is being used with the device of Austermann, which was used to reject claim 1 as detailed above under the corresponding rejection of claim 1.
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austermann.
Regarding claim 8, Austermann discloses the fluid collection device of claim 7 wherein the plurality of flanges include two sets of longitudinally extending flanges separated by a web therebetween. The examiner notes that per paragraph 0040 the at least one flange may include two or more flanges and may be from any suitable material such as cloth, paper, plastic, thermoplastic elastomer, and more (para. 0041). As best understood by the examiner, the web of the disclosure is the material in between the two flange sets (see instant specification para. 0036, 0066, where web 238 is seen in figure 2c). The examiner notes that as Austermann discloses support for the flange consisting of up to four flanges and may be made from various materials including elastomers, and fabrics, and per MPEP Section 2144 VI B “the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced”, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to duplication the flanges seen in the figure of Austermann, up to a total of four flanges to achieve the predictable result of securing the collection device. As such the portion of the flange between the four flanges, made from such aforementioned materials, is interpreted to be the web that separates the flanges.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781