DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed September 17, 2025.
Status of Claims
1. Claims 1-3, 6-7, 9-10 and 12 are pending and currently under consideration for patentability.
Claims 4, 5, 8 and 11 are cancelled as of the September 17, 2025 claim amendment.
Response to Arguments
2. Applicant's arguments filed September 17, 2025 have been fully considered but they are not persuasive.
With regard to applicant’s argument that the only reference having an aperture is oriented horizontally, examiner respectfully disagrees. Applicant is reminded that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The primary reference of rejection, Mendonca (US 6,110,156), already discloses a pouch (30) having an open top (open upper edge, 40) and a bottom edge which is vertically aligned below the open top and the pouch extending upwardly from the bottom edge toward the open top (40; Figs. 1-4, 9 and 11; col. 2, line 64 – col. 3, line 32). The rejection does not intend to bodily incorporate and replace the vertically oriented pouch of Mendonca with the horizontally oriented pouch of Walters, but rather, intends to modify the bottom edge of the pouch disclosed by Mendonca to include an aperture for accommodating a vent portion of the ostomy bag therethrough, similar to that disclosed by Walters. It should also be noted that the pouch of Walters is fully capable of being vertically oriented.
With regard to applicant’s argument that neither cited reference provides for flaring of the pouch, i.e. they are both rectangular, the arguments have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Green (US PGPUB 2008/0282441) is newly presented as a secondary reference of the instant rejection for rendering obvious these newly presented claim limitations.
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.
3. Claim(s) 1-3, 6-7, 9-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Mendonca (US 6,110,156) in view of Walters (US 5,651,777) in view of Green (US PGPUB 2008/0282441).
4. With regard to claims 1-3, 6-7 and 9-10, Mendonca discloses a clothing article (garment, 10) for holding an ostomy bag (ostomy bag, 110) while the ostomy bag (110) is fluidly coupled to a stoma in a torso of a user (abstract; Figs. 1-4, 9-11; col. 3, lines 33-41; col. 4, lines 34-47), the clothing article (10) comprising: an undergarment (Fig. 1) being configured to be worn over a lower torso and genitals of the user (col. 1, lines 4-5; col. 3, lines 42-46), the undergarment (10) having a waistband (waistband portion, 12’; best seen in Figs. 9-11) which extends around the torso of the user when the undergarment (10) is worn by the user (col. 3, lines 16-23); and a pouch (pocket, 30) being mounted to an outer surface (portion, 90) of the waistband (12’; best seen in Figs. 9 and 11) and being configured for holding the ostomy bag (110), the pouch (30) comprising a wall (layer of pocket material, 20) bounding a cavity (inner pocket, 80) for at least partially containing the ostomy bag (110; Figs. 1, 2, 9, 11), the pouch (30) being unbuttonable from the waistband (12’; col. 2, line 64 – col. 3, line 32). Mendonca discloses that the pouch (30) has an open top (open upper edge, 40) and a bottom edge (70) which is vertically aligned below the open top (40) and the pouch (30) extending upwardly from the bottom edge toward the open top (40; Figs. 1-4, 9 and 11; col. 2, line 64 – col. 3, line 32). Mendonca discloses that the wall (80) comprises a resiliently stretchable material such that the wall stretches to accommodate an expansion of the ostomy bag (110) caused by the ostomy bag filling with waste (Figs. 3-4; col. 4, lines 19-33).
Mendonca fails to explicitly disclose that the pouch is removably attached to the waistband; wherein the pouch is selectively positionable in one of a plurality of locations along the front side of the waistband between a pair of lateral sides of the waistband; and further comprising a plurality of first mating members and a plurality of second mating members the plurality of first mating members being coupled to the front side of the waistband of the undergarment, the plurality of second mating members being coupled to the wall of the pouch, at least a portion of the plurality of first mating members being coupled to at least a portion of the plurality of second mating members when the pouch is positioned in each location of the plurality of locations.
However, Walters discloses an ostomy pouch support (10; abstract; Figs. 1-4) for holding an ostomy bag (ostomy pouch, 28) during use, wherein the ostomy pouch support includes a waistband (belt, 11) with male snaps (20); and a pouch (sling, 22), for holding the ostomy bag (28), which is removably attached to the waistband (11); and wherein the pouch (22) is selectively positionable in one of a plurality of locations (22 can be positioned laterally in either direction via offset snaps in either direction) along the front side of the waistband (11) between a pair of lateral sides of the waistband (11; via female snaps, 26; best seen in Figs. 2-3); and further comprising a plurality of first mating members (20) and a plurality of second mating members (26) the plurality of first mating members being coupled to the front side of the waistband (11) of the undergarment, the plurality of second mating members (26) being coupled to the wall of the pouch (22), at least a portion of the plurality of first mating members (20) being coupled to at least a portion of the plurality of second mating members (26) when the pouch (22) is positioned in each location of the plurality of locations (col. 3, lines 6-55).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the pouch and undergarment disclosed by Mendonca so that that the pouch is removably attached to the waistband, similar to that disclosed by Walters, in order to allow for the attachment of various sized pouches, depending on the size of the ostomy bad to be used, as suggested by Walters in column 3, lines 21-44. Additionally, one having ordinary skill in the art would recognize the benefits of being able to fully remove the pouch from the waistband in order to visibly shield the ostomy bag during transport, removal, emptying or replacement of bags.
Additionally, Mendonca fails to explicitly disclose that the pouch has an aperture extending through the wall to the cavity, the aperture having a size such that the aperture is configured for receiving a vent portion of the ostomy bag therethrough; wherein the aperture is positioned such that the vent portion of the ostomy bag is positioned below the stoma when the undergarment is worn by the user.
However, Walters disclose that the pouch (22) has an aperture (C-shaped cutout, 24 and opening on opposite end for pouch clamp, 23) extending through the wall to the cavity (Figs. 1-3), the aperture (24) having a size such that the aperture (24) is configured for receiving a vent portion (stoma 25 attachment and 23) of the ostomy bag (28) therethrough (col. 3, lines 21-55); wherein the aperture (24 and opposite open end) is positioned such that the vent portion (23) of the ostomy bag (28) fully capable of being positioned below the stoma (25) when the undergarment (11) is worn by the user (col. 3, lines 21-55).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the bottom edge of the pouch disclosed by Mendonca in view of Walters to include an aperture aligned with the open top of the pouch, similar to that disclosed by Walters, in order to provide the pouch with a clearance opening for simple placement of the ostomy pouch against the user’s stoma and an opening for simple emptying of the pouch, as suggested by Walters in column 3, lines 26-55.
Further, while Mendonca discloses that the wall (80) has a front panel (20, 80) angled downwardly toward the aperture (as modified above) from one of the associated lateral edges (30) of the front panel (Figs. 1-4, 7), Mendonca is silent in regard to the wall comprising a front panel and a rear panel, the front and rear panels being attached to each other along associated lateral edges and bottom edges thereof; and wherein the open top extends between associated upper edges of the front and rear panels; wherein the aperture extends between the associated bottom edges of the front and rear panels.
However, Walters discloses that the wall (22) comprising a front panel and a rear panel (Figs. 2, 3), the front and rear panels being attached to each other along associated lateral edges and bottom edges thereof (Figs. 2-3); wherein the open top (24) extends between associated upper edges of the front and rear panels (Figs. 2-3); and wherein the aperture (24 and opposite open end) extends between the associated bottom edges of the front and rear panels (Figs. 2-3).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the pouch disclosed by Mendonca in view of Walters so that that the pouch includes a front and rear panel attached along associated lateral edges, similar to that disclosed by Walters, in order to allow for the attachment of various sized independent removable and replaceable pouches, depending on the size of the ostomy bad to be used, as suggested by Walters in column 3, lines 21-44. Additionally, one having ordinary skill in the art would recognize the benefits of being able to fully remove the pouch from the waistband in order to visibly shield the ostomy bag during transport, removal, emptying or replacement of bags.
Finally, Mendonca and Walters are silent in regard to the pouch flaring extending upwardly from the aperture towards the open top.
However, Green discloses garments for holding post-surgical drain systems (abstract; Figs. 1, 3, 6), wherein the garment includes a pouch (pocket, 18) with a rounded bottom (24), an open top (20), and outwardly flared sides (22; [0021]) for receiving a post-surgical drain bulb (30; [0025]).
Accordingly, would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the shape of the pouch disclosed by Mendonca in view of Walters so that the pouch flares extending upwardly toward the open top, similar to that disclosed by Green, in order to snuggly receive and hold the ostomy bag firmly, while limiting lateral movement of the ostomy bag during use, as suggested by Green in paragraph [0021].
5. With regard to claim 12, Mendonca discloses a clothing article (garment, 10) for holding an ostomy bag (ostomy bag, 110) while the ostomy bag (110) is fluidly coupled to a stoma in a torso of a user (abstract; Figs. 1-4, 9-11; col. 3, lines 33-41; col. 4, lines 34-47), the clothing article (10) comprising: an undergarment (Fig. 1) being configured to be worn over a lower torso and genitals of the user (col. 1, lines 4-5; col. 3, lines 42-46), the undergarment (10) having a waistband (waistband portion, 12’; best seen in Figs. 9-11) which extends around the torso of the user when the undergarment (10) is worn by the user (col. 3, lines 16-23); and a pouch (pocket, 30) being mounted to an outer surface (portion, 90) of the waistband (12’; best seen in Figs. 9 and 11) and being configured for holding the ostomy bag (110), the pouch (30) comprising a wall (layer of pocket material, 20) bounding a cavity (inner pocket, 80) for at least partially containing the ostomy bag (110; Figs. 1, 2, 9, 11), the pouch (30) being unbuttonable from the waistband (12’; col. 2, line 64 – col. 3, line 32). Mendonca discloses that the pouch (30) has an open top (open upper edge, 40) and a bottom edge (70) which is vertically aligned below the open top (40) and the pouch (30) extending upwardly from the bottom edge toward the open top (40; Figs. 1-4, 9 and 11; col. 2, line 64 – col. 3, line 32). Mendonca discloses that the wall (80) comprises a resiliently stretchable material such that the wall stretches to accommodate an expansion of the ostomy bag (110) caused by the ostomy bag filling with waste (Figs. 3-4; col. 4, lines 19-33).
Mendonca fails to explicitly disclose that the pouch is removably attached to the waistband; wherein the pouch is selectively positionable in one of a plurality of locations along the front side of the waistband between a pair of lateral sides of the waistband; and further comprising a plurality of first mating members and a plurality of second mating members the plurality of first mating members being coupled to the front side of the waistband of the undergarment, the plurality of second mating members being coupled to the wall of the pouch, at least a portion of the plurality of first mating members being coupled to at least a portion of the plurality of second mating members when the pouch is positioned in each location of the plurality of locations.
However, Walters discloses an ostomy pouch support (10; abstract; Figs. 1-4) for holding an ostomy bag (ostomy pouch, 28) during use, wherein the ostomy pouch support includes a waistband (belt, 11) with male snaps (20); and a pouch (sling, 22), for holding the ostomy bag (28), which is removably attached to the waistband (11); and wherein the pouch (22) is selectively positionable in one of a plurality of locations (22 can be positioned laterally in either direction via offset snaps in either direction) along the front side of the waistband (11) between a pair of lateral sides of the waistband (11; via female snaps, 26; best seen in Figs. 2-3); and further comprising a plurality of first mating members (20) and a plurality of second mating members (26) the plurality of first mating members being coupled to the front side of the waistband (11) of the undergarment, the plurality of second mating members (26) being coupled to the wall of the pouch (22), at least a portion of the plurality of first mating members (20) being coupled to at least a portion of the plurality of second mating members (26) when the pouch (22) is positioned in each location of the plurality of locations (col. 3, lines 6-55).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the pouch and undergarment disclosed by Mendonca so that that the pouch is removably attached to the waistband, similar to that disclosed by Walters, in order to allow for the attachment of various sized pouches, depending on the size of the ostomy bad to be used, as suggested by Walters in column 3, lines 21-44. Additionally, one having ordinary skill in the art would recognize the benefits of being able to fully remove the pouch from the waistband in order to visibly shield the ostomy bag during transport, removal, emptying or replacement of bags.
Additionally, Mendonca fails to explicitly disclose that the pouch has an aperture extending through the wall to the cavity, the aperture having a size such that the aperture is configured for receiving a vent portion of the ostomy bag therethrough; wherein the aperture is positioned such that the vent portion of the ostomy bag is positioned below the stoma when the undergarment is worn by the user.
However, Walters disclose that the pouch (22) has an aperture (C-shaped cutout, 24 and opening on opposite end for pouch clamp, 23) extending through the wall to the cavity (Figs. 1-3), the aperture (24) having a size such that the aperture (24) is configured for receiving a vent portion (stoma 25 attachment and 23) of the ostomy bag (28) therethrough (col. 3, lines 21-55); wherein the aperture (24 and opposite open end) is positioned such that the vent portion (23) of the ostomy bag (28) fully capable of being positioned below the stoma (25) when the undergarment (11) is worn by the user (col. 3, lines 21-55).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the bottom edge of the pouch disclosed by Mendonca in view of Walters to include an aperture aligned with the open top of the pouch, similar to that disclosed by Walters, in order to provide the pouch with a clearance opening for simple placement of the ostomy pouch against the user’s stoma and an opening for simple emptying of the pouch, as suggested by Walters in column 3, lines 26-55.
Further, while Mendonca discloses that the wall (80) has a front panel (20, 80) angled downwardly toward the aperture (as modified above) from one of the associated lateral edges (30) of the front panel (Figs. 1-4, 7), Mendonca is silent in regard to the wall comprising a front panel and a rear panel, the front and rear panels being attached to each other along associated lateral edges and bottom edges thereof; and wherein the open top extends between associated upper edges of the front and rear panels; wherein the aperture extends between the associated bottom edges of the front and rear panels.
However, Walters discloses that the wall (22) comprising a front panel and a rear panel (Figs. 2, 3), the front and rear panels being attached to each other along associated lateral edges and bottom edges thereof (Figs. 2-3); wherein the open top (24) extends between associated upper edges of the front and rear panels (Figs. 2-3); and wherein the aperture (24 and opposite open end) extends between the associated bottom edges of the front and rear panels (Figs. 2-3).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the pouch disclosed by Mendonca in view of Walters so that that the pouch includes a front and rear panel attached along associated lateral edges, similar to that disclosed by Walters, in order to allow for the attachment of various sized independent removable and replaceable pouches, depending on the size of the ostomy bad to be used, as suggested by Walters in column 3, lines 21-44. Additionally, one having ordinary skill in the art would recognize the benefits of being able to fully remove the pouch from the waistband in order to visibly shield the ostomy bag during transport, removal, emptying or replacement of bags.
Finally, Mendonca and Walters are silent in regard to the pouch flaring extending upwardly from the aperture towards the open top.
However, Green discloses garments for holding post-surgical drain systems (abstract; Figs. 1, 3, 6), wherein the garment includes a pouch (pocket, 18) with a rounded bottom (24), an open top (20), and outwardly flared sides (22; [0021]) for receiving a post-surgical drain bulb (30; [0025]).
Accordingly, would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the shape of the pouch disclosed by Mendonca in view of Walters so that the pouch flares extending upwardly toward the open top, similar to that disclosed by Green, in order to snuggly receive and hold the ostomy bag firmly, while limiting lateral movement of the ostomy bag during use, as suggested by Green in paragraph [0021].
Conclusion
6. 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.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781