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
Claims 1-24 are pending and examined on the merits.
Claims 1, 11, 14, 19, 20, and 22-24 are currently amended.
Response to Amendment
Applicant amendments filed 03/23/2026 have been fully considered.
Claim Objections:
Applicant amended claim 22 to overcome a minor informality. Accordingly, the objection to claim 22 is withdrawn.
Response to Arguments
Applicant provided amendments to the independent claims which necessitates a new ground of rejection. Accordingly, Applicant’s arguments filed 03/23/2026 have been fully considered. Michaud (U.S. Patent No. 4,270,539 A), Tsai (U.S. Pre Grant Pub. No. 2010/0234820 A1), and Triunfol (U.S. Patent No. 4,610,675 A) have been introduced/reintroduced as primary and secondary references in the present rejection for disclosing and rendering obvious the limitations presented via the amendments.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9, 11-17, and 19-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Michaud (U.S. Patent No. 4,270,539 A).
PNG
media_image1.png
740
617
media_image1.png
Greyscale
Regarding claim 1, Michaud, with reference to Image 1 above, teaches: A fluid collection assembly (see at least Abstract and Fig. 2), comprising;
a fluid impermeable barrier defining a chamber (see Image 1), at least one opening configured to be positioned a least proximate to a urethral opening of an individual (see at least Fig. 1 and Image 1), and an outlet (see Image 1); the fluid impermeable barrier including one or more sidewalls (see Image 1) having at least one exterior surface and at least one interior surface opposite the at least one exterior surface (at least inherent; see also Image 1), the at least one exterior surface including a skin facing side that at least partially defines the opening (as broadly recited, the exterior surface includes a skin facing side that partially defines the opening when the flange 22 is mounted onto the drain conduit; see for example Figs. 1-2 and col. 5, line 67 thru col. 6, line 1), the at least one interior surface defining the chamber (see Image 1), wherein the fluid impermeable barrier does not extend across the at least one opening (see Image 1); and
one or more fluid flow features (see Image 1) at least one of defined by, formed by, or disposed on at least a portion of the fluid impermeable barrier or on at least a portion of the at least one exterior surface of the fluid impermeable barrier (see Image 1), the one or more fluid flow features configured to remove trapped fluids between the at least one exterior surface and skin of an individual (col. 6, lines 64-67 teach that the drainage conduit may be corrugated to permit sharp bending; as broadly recited, the fluid impermeable barrier can be bent away from a user in order to encourage more evaporation of fluid on a skin of an individual), the one or more fluid flow features including at least one of:
a plurality of recesses extending partially into the one or more sidewalls of the fluid impermeable barrier from the skin facing side of the at least one exterior surface (as shown in Image 1, the corrugations partially extend into the one or more sidewalls and are considered recesses; additionally, as broadly recited, the entirety of the exterior surface is considered to be the skin facing side at least because it faces the skin of the inner thighs of a wearer);
a plurality of protrusions extending outwardly from a base surface of the skin facing side of the at least one exterior surface of the fluid impermeable barrier (as shown in Image 1, the corrugations extend outwardly from a base surface of the fluid impermeable barrier and are thus considered protrusions; additionally, as broadly recited, the entirety of the exterior surface is considered to be the skin facing side at least because it faces the skin of the inner thighs of a wearer);
a hydrophobic layer disposed on at least a portion of a skin facing side of the at least one exterior surface.
Regarding claim 2, Michaud teaches the invention as discussed above in claim 1. Additionally, Michaud teaches wherein the at least one opening is an elongated opening (see Image 1).
Regarding claim 3, Michaud teaches the invention as discussed above in claim 1. Additionally, Michaud teaches wherein the one or more fluid flow features include the plurality of recesses (see corrugations 32c in Fig. 2).
Regarding claim 4, Michaud teaches the invention as discussed above in claim 3. Additionally, Michaud teaches wherein:
the fluid impermeable barrier includes a first end and a second end opposite the first end (at least inherent); and
at least one of the plurality of recesses extends between the first end of the fluid impermeable barrier and the second end of the fluid impermeable barrier (as shown in Fig. 2, the corrugations 32c extend from a first end at rim 46 and a second end at portion 32b).
Regarding claim 5, Michaud teaches the invention as discussed above in claim 3. Additionally, Michaud teaches wherein at least one of the plurality of recesses extends circumferentially about the fluid impermeable barrier (see Fig. 2).
Regarding claim 6, Michaud teaches the invention as discussed above in claim 3. Additionally, Michaud teaches wherein at least one of the plurality of recesses is curved (see Fig. 2).
Regarding claim 7, Michaud teaches the invention as discussed above in claim 6. Additionally, Michaud teaches wherein the at least one of the plurality of recesses is concavely curved relative to the at least one opening (as shown in Fig. 2, the corrugations 32c are concavely curved).
Regarding claim 8, Michaud teaches the invention as discussed above in claim 3. Additionally, Michaud teaches wherein at least some of the plurality of recesses intersect with each other (as shown in Fig. 2, the corrugations 32c are directly adjacent one another and therefore intersect with each other).
Regarding claim 9, Michaud teaches the invention as discussed above in claim 1. Additionally, Michaud teaches wherein the one or more fluid flow features includes the plurality of protrusions (see corrugations 32c in Fig. 2).
Regarding claim 11, Michaud teaches the invention as discussed above in claim 1. Additionally, Michaud teaches wherein the one or more fluid flow features further includes a wicking layer disposed on at least a portion of the skin facing side of the at least one exterior surface (see pad 30 in Fig. 2 and col. 6, lines 27-29).
Regarding claim 12, Michaud teaches the invention as discussed above in claim 1. Additionally, Michaud teaches further comprising at least one porous material disposed in the chamber (see pad 30 in Fig. 2 and col. 6, lines 27-29).
Regarding claim 13, Michaud teaches the invention as discussed above in claim 1. Additionally, Michaud teaches further comprising an substantially unoccupied reservoir located at an end of the fluid impermeable barrier (see for example conduit 50 in Figs. 1 and 2).
Regarding claim 14, Michaud, with reference to Image 1 above, teaches: A method of using a fluid collection assembly (see at least Abstract and Fig. 2), the method comprising:
Positioning at least one opening (see Image 1) defined by a fluid impermeable barrier of the fluid collection assembly (Id.) to be at least proximate to a urethral opening of an individual (see Fig. 1), the fluid impermeable barrier defining an outlet (see Image 1), the fluid impermeable barrier including one or more sidewalls (Id.) having at least one exterior surface and at least one interior surface opposite the at least one exterior surface (at least inherent; see also Image 1), the at least one exterior surface including a skin facing side that at least partially defines the opening (as broadly recited, the exterior surface includes a skin facing side that partially defines the opening when the flange 22 is mounted onto the drain conduit; see for example Figs. 1-2 and col. 5, line 67 thru col. 6, line 1), the at least one interior surface defining a chamber (see Image 1), wherein the at least one opening and the outlet provide access to the chamber (Id.), wherein the fluid impermeable barrier does not extend across the at least one opening (Id.); and
with one or more fluid flow features (see Image 1), removing trapped fluids from between the at least one exterior surface of the fluid impermeable barrier and skin of the individual to a location that is different from between the at least one exterior surface of the fluid impermeable barrier and the skin of the individual (col. 6, lines 64-67 teach that the drainage conduit may be corrugated to permit sharp bending; as broadly recited, the fluid impermeable barrier can be bent away from a user in order to encourage more evaporation of fluid on a skin of an individual), wherein the one or more fluid flow features are at least one of defined by, formed by, or disposed on at least a portion of the fluid impermeable barrier or on at least a portion of the at least one exterior surface (see Image 1), the one or more fluid flow features including at least one of:
a plurality of recesses extending partially into the one or more sidewalls of the fluid impermeable barrier from at least the skin facing side of the at least one exterior surface (as shown in Image 1, the corrugations partially extend into the one or more sidewalls and are considered recesses; additionally, as broadly recited, the entirety of the exterior surface is considered to be the skin facing side at least because it faces the skin of the inner thighs of a wearer);
a plurality of protrusions extending outwardly from a base surface of at least the skin facing side of the at least one exterior surface of the fluid impermeable barrier (as shown in Image 1, the corrugations extend outwardly from a base surface of the fluid impermeable barrier and are thus considered protrusions; additionally, as broadly recited, the entirety of the exterior surface is considered to be the skin facing side at least because it faces the skin of the inner thighs of a wearer);
a hydrophobic layer disposed on at least a portion of a skin facing side of the at least one exterior surface.
Regarding claim 15, Michaud teaches the method as described above in claim 14. Additionally, in Michaud’s method, the one or more fluid flow features includes the one or more recesses (see corrugations 32c in Fig. 2); and removing trapped fluids from between the at least one exterior surface of the fluid impermeable barrier and skin of the individual to a location that is different from between the at least one exterior surface of the fluid impermeable barrier and the skin of the individual includes flowing air through the one or more recesses to remove vapor of the trapped fluids (as broadly recited, this limitation is met by the method of Michaud; for example, when the drainage conduit is bent away from the fluid impermeable barrier, air will necessarily flow through the one or more recesses to remove vapor of the trapped fluids).
Regarding claim 16, Michaud teaches the method as described above in claim 14. Additionally, in Michaud’s method, the one or more fluid flow features include the one or more recesses (see corrugations 32c in Fig. 2); and removing trapped fluids from between the at least one exterior surface of the fluid impermeable barrier and skin of the individual to a location that is different from between the at least one exterior surface of the fluid impermeable barrier and the skin of the individual includes at least one of flowing air through the one or more recesses or flowing the trapped fluids through the one or more recesses (as broadly recited, this limitation is met by the method of Michaud; for example, when the drainage conduit is bent away from the fluid impermeable barrier, air will necessarily flow through the one or more recesses to remove vapor of the trapped fluids).
Regarding claim 17, Michaud teaches the method as described above in claim 14. Additionally, in Michaud’s method, the one or more fluid flow features include the plurality of protrusions (see corrugations 32c in Fig. 2); and removing trapped fluids from between the at least one exterior surface of the fluid impermeable barrier and skin of the individual to a location that is different from between the at least one exterior surface of the fluid impermeable barrier and the skin of the individual includes at least one of flowing air through one or more interconnected channels formed between the plurality of protrusions or flowing the trapped fluids through the one or more interconnected channels (as broadly recited, this limitation is met by the method of Michaud; for example, when the drainage conduit is bent away from the fluid impermeable barrier, air will necessarily flow through the one or more protrusions to remove vapor of the trapped fluids).
Regarding claim 19, Michaud teaches the method as described above in claim 14. Additionally, in Michaud’s method, wherein the one or more fluid flow features further includes a wicking layer disposed on at least a portion of the skin facing side of the at least one exterior surface (see pad 30 in Fig. 2 and col. 6, lines 27-29); and removing trapped fluids from between the at least one exterior surface of the fluid impermeable barrier and skin of the individual to a location that is different from between the at least one exterior surface of the fluid impermeable barrier and the skin of the individual includes at least one of flowing air through one or more interconnected channels formed in the wicking layer or flowing the trapped fluids through the one or more interconnected channels (col. 7, lines 3-5 teach that a pump can be provided to direct urine into a container; therefore, when a pump is used, trapped fluids will flow through the pad 30 in order to be removed from the device).
Regarding claim 20, Michaud, with reference to Image 1 above, teaches: A fluid collection system (see Abstract), comprising:
a fluid collection assembly (see at least Abstract and Fig. 2) including:
a fluid impermeable barrier defining a chamber (see Image 1), at least one opening configured to be positioned a least proximate to a urethral opening of an individual (see at least Fig. 1 and Image 1), and an outlet (see Image 1); the fluid impermeable barrier including one or more sidewalls (see Image 1) having at least one exterior surface and at least one interior surface opposite the at least one exterior surface (at least inherent; see also Image 1), the at least one exterior surface including a skin facing side that at least partially defines the opening (as broadly recited, the exterior surface includes a skin facing side that partially defines the opening when the flange 22 is mounted onto the drain conduit; see for example Figs. 1-2 and col. 5, line 67 thru col. 6, line 1), the at least one interior surface defining the chamber (see Image 1), wherein the fluid impermeable barrier does not extend across the at least one opening (see Image 1); and
one or more fluid flow features (see Image 1) at least one of defined by, formed by, or disposed on at least a portion of the fluid impermeable barrier or on at least a portion of the at least one exterior surface of the fluid impermeable barrier (see Image 1), the one or more fluid flow features configured to remove trapped fluids between the at least one exterior surface and skin of an individual (col. 6, lines 64-67 teach that the drainage conduit may be corrugated to permit sharp bending; as broadly recited, the fluid impermeable barrier can be bent away from a user in order to encourage more evaporation of fluid on a skin of an individual), the one or more fluid flow features including at least one of:
a plurality of recesses extending partially into the one or more sidewalls of the fluid impermeable barrier from at least the skin facing side of the at least one exterior surface (as shown in Image 1, the corrugations partially extend into the one or more sidewalls and are considered recesses; additionally, as broadly recited, the entirety of the exterior surface is considered to be the skin facing side at least because it faces the skin of the inner thighs of a wearer);
a plurality of protrusions extending outwardly from a base surface of at least the skin facing side of the at least one exterior surface of the fluid impermeable barrier (as shown in Image 1, the corrugations extend outwardly from a base surface of the fluid impermeable barrier and are thus considered protrusions; additionally, as broadly recited, the entirety of the exterior surface is considered to be the skin facing side at least because it faces the skin of the inner thighs of a wearer);
a hydrophobic layer disposed on at least a portion of a skin facing side of the at least one exterior surface; or
a fluid storage container (col. 7, lines 1-3 teach a storage container);
a vacuum source configured to apply a suction force (col. 7, lines 3-5 teach that a pump can be provided to direct urine into a container); and
at least one tube that places the chamber, the fluid storage container, and the vacuum source in fluid communication with each other (see for example conduit extension 50 in Figs. 1-2).
Regarding claim 21, Michaud teaches the invention as discussed above in claim 3. Additionally, Michaud teaches wherein at least some of the plurality of recesses are spaced from the opening (see Fig. 2).
Regarding claim 22, Michaud teaches the invention as discussed above in claim 3. Additionally, Michaud teaches wherein at least one of the plurality of recesses extend from the opening (as shown in Fig. 2, rim 46 defines the opening 48; see col. 6, lines 45-47; immediately adjacent the rim 46, conduit 32 beings to taper towards corrugations 32c; therefore, the tapering is considered to extend from the opening 48 which in turn leads the corrugations 32c to extend from the opening 48).
Claims 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Michaud (U.S. Patent No. 4,270,539 A) in view of Tsai (U.S. Pre Grant Pub. No. 2010/0234820 A1).
Regarding claims 10 and 18, Michaud teaches the invention/method as discussed above in claims 1 and 14. However, Michaud fails to explicitly teach wherein the one or more fluid flow features includes the hydrophobic layer, as required by the claims.
Tsai teaches an analogous fluid collection system comprising a hydrophobic layer disposed on at least a portion of the at least one exterior surface (see liquid acquisition material 22 in Fig. 2 and para. [0039]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device/method of Michaud to incorporate the teachings of Tsai by including a hydrophobic layer at least in order to promote the interior environment of the device to remain relatively dry, thereby minimizing leakage concern and bacterial growth, as taught by Tsai (see para. [0039]).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Michaud (U.S. Patent No. 4,270,539 A) in view of Triunfol (U.S. Patent No. 4,610,675 A).
Regarding claim 23, Michaud teaches the invention as discussed above in claim 12. Additionally, Michaud teaches a wicking layer disposed on at least a portion of the skin facing side of the at least one exterior surface (see pad 30 in Fig. 2 and col. 6, lines 27-29).
However, Michaud fails to explicitly teach wherein the one or more fluid flow features includes at least one of the hydrophobic layer or the wicking layer and the at least one of the hydrophobic layer or the wicking layer is distinct and separate from the at least one porous material, as required by the claim.
Triunfol teaches an analogous female external urine collection device (see Abstract) comprising pad 1 composed of a core 5 formed of a flexible material, such as polyurethane, and an outer impervious cover 6 which can be formed of a material such as polyethylene (see Fig. 3 and col. 2, lines 58-62).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Michaud to incorporate the teachings of Triunfol by including an outer impervious cover over the fluid impermeable barrier, at positions away from the plurality of recesses, such that the impervious cover is distinct and separate from the porous material at least because such structural configuration is well known in the art, as evidenced by its disclosure in Triunfol (see at least Fig. 3 and col. 2, lines 58-62). Therefore, one of ordinary skill in the art would have been motivated to include an impervious cover with the device of Michaud at least in order to better protect the exterior surface from unwanted fluid absorption.
Regarding claim 24, Michaud teaches the invention as discussed above in claim 1. Additionally, Michaud teaches a wicking layer disposed on at least a portion of the skin facing side of the at least one exterior surface (see pad 30 in Fig. 2 and col. 6, lines 27-29).
However, Michaud fails to explicitly teach wherein the one or more fluid flow features includes at least one of the hydrophobic layer or the wicking layer and the at least one of the hydrophobic layer or the wicking layer is not positioned within the chamber, as required by the claim.
Triunfol teaches a pad 1 composed of a core 5 formed of a flexible material, such as polyurethane, and an outer impervious cover 6 which can be formed of a material such as polyethylene (see Fig. 3 and col. 2, lines 58-62).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Michaud to incorporate the teachings of Triunfol by including an outer impervious cover over the fluid impermeable barrier, at positions away from the plurality of recesses, such that the at least one of the hydrophobic layer or the wicking layer is not positioned within the chamber at least because such structural configuration is well known in the art, as evidenced by its disclosure in Triunfol (see at least Fig. 3 and col. 2, lines 58-62). Therefore, one of ordinary skill in the art would have been motivated to include an impervious cover with the device of Michaud at least in order to better protect the exterior surface from unwanted fluid absorption.
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 JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/JIHAD DAKKAK/ Examiner, Art Unit 3781
/PHILIP R WIEST/ Primary Examiner, Art Unit 3781