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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/12/2026 has been entered.
Response to Amendment
Applicant’s amendments filed on 01/12/2026 have been fully considered. Claims 1-3, 5, 7, 11, 13-14, 17, 19, 22-24, and 26-31 are pending in this application. Claims 1, 5, 7, 11, and 24 are amended. Claims 4, 6, 8-10, 12, 15-16, 18, 20-21, and 25 are cancelled.
Response to Arguments
Applicant's arguments filed 01/12/2026 have been fully considered but they are not persuasive. Regarding the argument that the prior art combination of Olsen in view of Murray teach the amended claim limitations of independent claims 1, 11 and 24, the argument is unpersuasive. The rejection of the amended claim limitations of claims 1, 11, and 24 will be addressed below.
Regarding the argument that the combination of Olsen in view of Murray does not teach at least a portion of the first sheet of comfort material forming a flap, wherein the flap covers the tab when the deployable drain is in the retracted portion and when the deployable drain is in an extended position, the argument is unpersuasive. The prior art of Murray teaches wherein at least a portion of the first sheet of comfort material forming a flap, wherein the flap covers the tab when the deployable drain is in the retracted portion and when the deployable drain is in an extended position (flap 60/tab is covered by a comfort layer 30 on the outer surface of the tab whether drain is in retracted portion or in deployed position; Paragraph 0056-0058; Figure 7-9). More specifically, paragraph 0056 of Murray reads “the comfort layer 30 may extend to cover a face of the profiled flap 60” meaning that the comfort layer 30 covers the flap 60/tab of the device whether in the extended or retracted position.
Though the same prior art reference is re-used herein, amended claims 1, 11, and 24 required a change in the grounds of rejection relying on additional prior art as detailed below in the prior art rejection.
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) 1-3, 5, 7, 13-14, 17, 19, 22, 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen et al. (Patent No. 6,336,918 B1) in view of Murray (Publication No. US 2016/0135983 A1).
Regarding claim 1, Olsen teaches an ostomy pouch (bag member 1; Abstract; Figures 6 and 7; Column 5, lines 26-34), comprising: inner and outer walls of flexible sheet material defining a cavity for containing stomal output (film blanks 2 and 3 are joined at edges to create cavity of bag member 1; Column 5, lines 26-34; Figures 6 and 7), the cavity comprising an upper section and a lower section (upper and lower sections of cavity of bag member 1; Figure 6-7); a deployable drain extending from the lower section of the cavity for draining stomal output from the cavity (discharge portion 8 with opening 9 to empty contents of bag is located in the lower section of cavity; Figure 6 and 7; Column 5, lines 44-54); and a fastener arrangement configured to retain the deployable drain in a retracted position (adhesive 16 on drain portion 8 and adhesive 22 on flap of cavity of bag; Figure 6 and 7; Column 6, lines 1-51), the fastener arrangement including a first fastener located on an exterior surface of the deployable drain (adhesive 16 is on exterior surface of portion 8; Figure 6 and 7; Column 6, lines 1-51). Olsen does not teach at least a first sheet of comfort material comprising a coating of ethylene-vinyl acetate; and a second fastener located on an exterior surface of the cavity wherein the second fastener comprises a tab, where the tab is secured to the outer wall of the lower section of the cavity; wherein the first sheet of comfort material is welded to the outer wall along a part of a periphery thereof terminating at left periphery and right periphery lower weld ends, a portion of the first sheet of comfort material not joined to the outer wall forming a flap that folds along a fold line extending between the lower weld ends; wherein the flap is configured to cover the deployable drain when the deployable drain is in the retracted position; wherein the flap covers the tab when the deployable drain is in the retracted position and when the deployable drain is in an extended position; wherein the coating coats at least an inner surface of the flap, the inner surface facing the deployable drain when the flap covers the deployable drain.
However, Murray teaches at least a first sheet of comfort material comprising a coating of ethylene-vinyl acetate (woven comfort layer 30 is formed with the walls 12, 14 of the pouch 10 – walls 12, 14 can be a laminate with one or more layers of ethylene vinyl acetate, meaning that comfort layer comprises the coating of EVA since it forming a part of the front 12 and rear walls 14; Paragraph 0026, 0046-47, 0056; Figure 8 and 9); and a second fastener located on an exterior surface of the cavity (flap fastener 68 is on the exterior surface of pouch 10; Figure 7; Paragraph 0051), wherein the second fastener comprises a tab (fastener 68 is a flap 60/tab; Figure 7; Paragraph 0051), where the tab is secured to the outer wall of the lower section of the cavity (flap 60/tab is secured to the outer wall of the pouch 10 located in the lower section of the cavity and above the drain; Figure 7; Paragraph 0051-0052); wherein the first sheet of comfort material is welded to the outer wall along a part of a periphery thereof terminating at left periphery and right periphery lower weld ends (comfort layer 30 is attached to rear wall 14 using the peripheral welded seam 16 and ends at the fold line/hinge of flap 60 which are the lower weld ends; Paragraph 0046-0047 and 0056-0057; Figures 8 and 9), a portion of the first sheet of comfort material not joined to the outer wall forming a flap that folds along a fold line extending between the lower weld ends (comfort layer 30 portion that extends over the flap 60/tab is not joined to the outer wall 14 to form the cavity is the flap that is the outer surface of flap 60/tab and folds at the hinge of the flap 60/tab between the lower weld end of 16 that concludes the weld between the outer wall and comfort layer 30 to form the flap 60; Paragraph 0046 and 0056-0058; Figure 7-9); wherein the flap is configured to cover the deployable drain when the deployable drain is in the retracted position (comfort layer 30 portion that covers flap 60/tab is designed to cover the drain 24 when the drain is in the retracted position; Figure 7-9; Paragraphs 0056-0058); wherein the flap covers the tab when the deployable drain is in the retracted position and when the deployable drain is in an extended position (comfort layer 30 portion that covers the flap 60/tab whether drain is in retracted portion or in deployed position; Paragraph 0056-0058; Figure 7-9); wherein the coating coats at least an inner surface of the flap (inner surface of comfort layer portion 30 has the coating of EVA so it can adhere to the flap 60/tab; Paragraph 0026, 0046-47, 0056; Figure 7-9), the inner surface facing the deployable drain when the flap covers the deployable drain (inner surface of comfort material faces the drain when the flap overlapping the tab covers drain; Figure 7-9; Paragraph 0056-0058).
Murray and Olsen are both considered to be analogous to the claimed invention because they are in the same field of ostomy bags. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Olsen to have the to incorporate the teachings of Murray and have the comfort layers with the tab and flap of Murray be external to the ostomy pouch of Olsen and comprising a laminate of EVA and the welded seam of Murray for the formation of the comfort layers with respect to the walls of the pouch. This allows for the pouch to provide softness and cushioning to the user when worn (Murray; Paragraph 0046) and provides discreteness to the drain (Murray; Paragraph 0056).
Regarding claim 2, Olsen in view of Murray teaches the pouch of claim 1. The combination of Olsen in view of Murray further teaches wherein the pouch comprises a second sheet of comfort material attached to the outer wall about at least part of the periphery thereof (Murray; comfort layer 30 can be attached to both of the front and rear walls 12, 14 of pouch 10 and attached to the outer walls by seams 16 that cover the periphery; Paragraph 0026, 0046, and 0056; Figure 7-9), wherein the first sheet of comfort material is attached to the outer wall via the second sheet of comfort material (Murray; comfort sheets 30 on both sides of outer walls can be connected to each other and to outer wall by the seam 16; Paragraph 0046 and 0056; Figure 7-9).
Regarding claim 3, Olsen in view of Murray teaches the pouch of claim 1. The combination of Olsen in view of Murray further teaches wherein the first sheet of comfort material is attached directly to the outer wall at the periphery thereof (Murray; comfort layer 30 can be attached to both of the front and rear walls 12, 14 of pouch 10 and attached to the outer walls by seams 16 that cover the periphery; Paragraph 0026, 0046, and 0056; Figure 7-9).
Regarding claim 5, Olsen in view of Murray teaches the pouch of claim 1. The combination of Olsen in view of Murray further teaches wherein the fold line is located between the deployable drain in the retracted position and an uppermost edge of the ostomy pouch (Murray; fold line is at hinge of fold 60 and is between the drain portion 24 and uppermost edge of pouch 10, best seen in Figure 7; Figure 6-9).
Regarding claim 7, Olsen in view of Murray teaches the pouch of claim 3. The combination of Olsen in view of Murray further teaches wherein the deployable drain is configured to move between an extended configuration for draining the stomal output from the cavity and a retracted configuration for storage of the deployable drain (Olsen; drain portion 8 is configured to move between an extended configuration, Figure 6, for draining, and retracted configuration; Figure 9, for storage; Column 6, lines 60 to Column 7, line 53), the flap configured to fold along the fold line, between a covering position in which the flap covers the deployable drain when the deployable drain is in the retracted configuration, and an access position, in which the deployable drain, in the retracted configuration is uncovered by the flap and is able to be accessed for deployment (Murray; fold line is at the hinge of flap 60 and is a line between two points about the periphery of pouch 10 and is configured to cover the drain, Figure 9, and can open to access the drain for deployment, Figure 6 and 8; Figures 6-9; Paragraph 0049-0058).
Regarding claim 13, Olsen in view of Murray teaches the pouch of claim 1. The combination of Olsen in view of Murray further teaches wherein the comfort material is a woven comfort material (Murray; woven comfort layer 30; Paragraph 0046).
Regarding claim 14, Olsen in view of Murray teaches the pouch of claim 5. The combination of Olsen in view of Murray further teaches wherein the flap is shaped such that an edge distal from the fold line conforms to the shape of the periphery of the ostomy pouch (Murray; edge of comfort material 30 that overlaps flap 60 conforms to shape of the periphery of pouch 10; Figure 9).
Regarding claim 17, Olsen in view of Murray teaches the pouch of claim 1. The combination of Olsen in view of Murray further teaches wherein the tab comprises a tab fold line about which the tab is configured to fold between a fastened configuration and an unfastened configuration wherein a foldable portion of the tab is exposed when the flap is in an access position (Murray; flap 60/tab has a fold line where the tab is to fold in a fastened configuration, Figure 9, and an unfastened configuration, Figure 8, and the foldable portion of the flap 60 is exposed when the comfort material 30 portion on the flap 60 are not in a closed position; see Figure 8 and 9).
Regarding claim 19, Olsen in view of Murray teaches the pouch of claim 1. The combination of Olsen in view of Murray further teaches further comprising a further sheet of comfort material, attached to the inner wall to form an inner comfort layer (Murray; comfort layer 30 to rear wall 14; Paragraph 0046; Figure 7); wherein an opening is provided proximate to the deployable drain between the inner comfort layer and the inner wall (Murray; entrance aperture 18 is proximate to drain 24 between wall 14 and comfort layer 30; Figure 7; Paragraph 0027); wherein the inner comfort layer is attached to the inner wall about a periphery thereof and the opening is provided by a gap in a region of the periphery (Murray; comfort layer 30 and rear wall 14 is attached with periphery seams and opening is located at the gap between the peripheries of left and right side of pouch 14; Figure 5; Paragraph 0046).
Regarding claim 22, Olsen in view of Murray teaches the pouch of claim 5. The combination of Olsen in view of Murray further teaches wherein the flap is configured to fold around the fold line such that to move to an access position the end of the flap distal from the fold line is lifted away from the pouch and towards the uppermost edge of the pouch (Murray; comfort material 30 portion that extends over the flap 60/tab is fully capable to fold at hinge of comfort material 30 portion of flap 60 so that to open the pouch, the flap edge 64 is lifted away from pouch 10 and towards uppermost edge of pouch – comfort material 30 attached onto the flap 60 is flexible and can move towards front and rear walls of pouch; Figure 8 and 9).
Regarding claim 24, Olsen teaches a method of forming an ostomy pouch (bag member 1; Abstract; Figures 6 and 7; Column 5, lines 26-34), the method comprising:
providing an inner wall and an outer wall which define a cavity for containing stomal output (film blanks 2 and 3 are joined at edges to create cavity of bag member 1; Column 5, lines 26-34; Figures 6 and 7), the cavity comprising an upper section and a lower section (upper and lower sections of cavity of bag member 1; Figure 6-7), and a deployable drain extending from the lower section for draining stomal output from the cavity (discharge portion 8 with opening 9 to empty contents of bag is located in the lower section of cavity; Figure 6 and 7; Column 5, lines 44-54). Olsen does not teach attaching a portion of a first sheet of comfort material to the outer wall along a part of a periphery thereof terminating at left periphery and right periphery lower weld ends, leaving a flap of a portion of the first sheet of comfort material not joined to the outer wall arranged to cover the deployable drain when in a retracted position, the first sheet of comfort material and an inner surface of the flap comprising a coating of ethylene-vinyl acetate, wherein the inner surface faces the deployable drain and contacts a fastener comprising a tab when the flap covers the deployable drain in the retracted position, wherein the flap also covers the tab when the deployable drain is in an extended position, wherein the tab is secured to an outer wall of the lower section of the cavity and wherein the flap folds along a fold line extending between the lower weld ends.
However, Murray teaches attaching a portion of a first sheet of comfort material to the outer wall (comfort layer 30 is attached to front wall 12 or rear wall 14; Paragraph 0046-0047 and 0056-0057; Figures 8 and 9) along a part of a periphery thereof terminating at left periphery and right periphery lower weld ends (comfort layer 30 is attached to rear wall 14 using the peripheral welded seam 16 and ends at the fold line/hinge of flap 60 which are the lower weld ends; Paragraph 0046-0047 and 0056-0057; Figures 8 and 9), leaving a flap (comfort layer 30 portion that extends over the flap 60/tab; Paragraph 0046 and 0056-0058; Figure 7-9) of a portion of the first sheet of comfort material not joined to the outer wall arranged to cover the deployable drain when in a retracted position (comfort layer 30 portion that covers the flap 60/tab whether drain is in retracted portion or in deployed position; Paragraph 0056-0058; Figure 7-9), the first sheet of comfort material and an inner surface of the flap comprising a coating of ethylene-vinyl acetate (woven comfort layer 30 is formed with the walls 12, 14 of the pouch 10 – walls 12, 14 can be a laminate with one or more layers of ethylene vinyl acetate, meaning that comfort layer comprises the coating of EVA since it forming a part of the front 12 and rear walls 14; Paragraph 0026, 0046-47, 0056; Figure 8 and 9), wherein the inner surface faces the deployable drain and contacts a fastener comprising a tab when the flap covers the deployable drain in the retracted position (comfort layer 30 portion that covers the flap 60/tab whether drain is in retracted portion or in deployed position and has an inner surface that faces the drain; Paragraph 0056-0058; Figure 7-9), wherein the flap also covers the tab when the deployable drain is in an extended position (comfort layer 30 portion that covers the flap 60/tab whether drain is in retracted portion or in deployed position; Paragraph 0056-0058; Figure 7-9), wherein the tab is secured to an outer wall of the lower section of the cavity and wherein the flap folds along a fold line extending between the lower weld ends.
Murray and Olsen are both considered to be analogous to the claimed invention because they are in the same field of ostomy bags. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Olsen to have the to incorporate the teachings of Murray and have the method of constructing the comfort layers with the tab and flap of Murray be external to the ostomy pouch of Olsen and comprising a laminate of EVA and the peripheral welds of Murray for the formation of the comfort layers with respect to the walls of the pouch. This allows for the pouch to provide softness and cushioning to the user when worn (Murray; Paragraph 0046) and provides discreteness to the drain (Murray; Paragraph 0056).
Regarding claim 26, Olsen in view of Murray teaches the pouch of claim 1. The combination of Olsen in view of Murray further teaches wherein the flap in a covering position, the flap is in contact with the tab (Murray; comfort material 30 is on the flap 60 has edge that covers drain 24 when in covered position, see Figure 8 and 9 of Murray, and is in direct contact with the flap 60/tab; see rejection of claim 1 above).
Claim(s) 11 and 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen et al. (Patent No. 6,336,918 B1) in view of Murray (Publication No. US 2016/0135983 A1), as applied to claim 1 above, and further in view of Fenton (Patent No. US 5,429,626 A).
Regarding claim 11, Olsen teaches an ostomy pouch (bag member 1; Abstract; Figures 6 and 7; Column 5, lines 26-34) comprising: inner and outer walls of flexible sheet material defining a cavity for containing stomal output (film blanks 2 and 3 are joined at edges to create cavity of bag member 1; Column 5, lines 26-34; Figures 6 and 7), the cavity comprising an upper section and a lower section (upper and lower sections of cavity of bag member 1; Figure 6-7); a deployable drain extending from the lower section for draining stomal output from the cavity (discharge portion 8 with opening 9 to empty contents of bag; Figure 6 and 7; Column 5, lines 44-54), a fastener arrangement configured to retain the deployable drain in a retracted position (adhesive 16 on drain portion 8 and adhesive 22 on flap of cavity of bag; Figure 6 and 7; Column 6, lines 1-51).
Olsen does not teach at least a first sheet of comfort material comprising a coating of ethylene-vinyl acetate; the fastener arrangement including a tab, where the tab is secured to the lower section of the outer wall of the cavity; wherein the first sheet of comfort material is welded to the outer wall along a part of a periphery thereof terminating at left periphery and right periphery lower weld ends, a portion of the first sheet of comfort material not joined to the outer wall forming a flap that folds along a fold line extending between the lower weld ends; wherein the flap is configured to cover the deployable drain when the deployable drain is in a retracted position; wherein the flap covers the tab when the deployable drain is in the retracted position and when the deployable drain is in an extended position; wherein the coating coats at least an inner surface of the flap, the inner surface facing the deployable drain when the flap covers the deployable drain.
However, Murray teaches at least a first sheet of comfort material comprising a coating of ethylene-vinyl acetate (woven comfort layer 30 is formed with the walls 12, 14 of the pouch 10 – walls 12, 14 can be a laminate with one or more layers of ethylene vinyl acetate, meaning that comfort layer comprises the coating of EVA since it forming a part of the front 12 and rear walls 14; Paragraph 0026, 0046-47, 0056; Figure 8 and 9); the fastener arrangement including a tab (fastener 68 is a flap 60; Figure 7; Paragraph 0051), where the tab is secured to the lower section of the outer wall of the cavity (flap 60 is secured to the lower section of the cavity on the outer wall of the pouch 10 and above the drain; Figure 7; Paragraph 0051-0052); wherein the first sheet of comfort material is welded to the outer wall along a part of a periphery thereof terminating at left periphery and right periphery lower weld ends (comfort layer 30 is attached to rear wall 14 using the peripheral welded seam 16 and ends at the fold line/hinge of flap 60 which are the lower weld ends; Paragraph 0046-0047 and 0056-0057; Figures 8 and 9), a portion of the first sheet of comfort material not joined to the outer wall forming a flap that folds along a fold line extending between the lower weld ends (comfort layer 30 portion that extends over the flap 60/tab is not joined to the outer wall 14 to form the cavity is the flap that is the outer surface of flap 60/tab and folds at the hinge of the flap 60/tab between the lower weld end of 16 that concludes the weld between the outer wall and comfort layer 30 to form the flap 60; Paragraph 0046 and 0056-0058; Figure 7-9); wherein the flap is configured to cover the deployable drain when the deployable drain is in a retracted position (comfort layer 30 portion that covers flap 60/tab is designed to cover the drain 24 when the drain is in the retracted position; Figure 7-9; Paragraphs 0056-0058); wherein the flap covers the tab when the deployable drain is in the retracted position and when the deployable drain is in an extended position (comfort layer 30 portion that covers the flap 60/tab whether drain is in retracted portion or in deployed position; Paragraph 0056-0058; Figure 7-9); wherein the coating coats at least an inner surface of the flap (inner surface of comfort layer portion 30 has the coating of EVA so it can adhere to the flap 60/tab; Paragraph 0026, 0046-47, 0056; Figure 7-9), the inner surface facing the deployable drain when the flap covers the deployable drain (inner surface of comfort material faces the drain when the flap overlapping the tab covers drain; Figure 7-9; Paragraph 0056-0058).
Murray and Olsen are both considered to be analogous to the claimed invention because they are in the same field of ostomy bags. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Olsen to have the to incorporate the teachings of Murray and have the comfort layers with the tab and flap of Murray be external to the ostomy pouch of Olsen and comprising a laminate of EVA and the welded seam of Murray for the formation of the comfort layers with respect to the walls of the pouch. This allows for the pouch to provide softness and cushioning to the user when worn (Murray; Paragraph 0046) and provides discreteness to the drain (Murray; Paragraph 0056).
The combination of Olsen in view of Murray does not teach wherein the coating is applied as a web and the web comprises a mass and a plurality of voids; and wherein the plurality of voids make up at least 50% of the web.
However, Fenton teaches wherein the coating is applied as a web (coating of EVA adhesive is a web; Column 1, line 51 to Column 2, line 5 and Column 3, line 8-41) and the web comprises a mass and a plurality of voids (obvious that an EVA web contains a mass and a plurality of voids; Column 1, line 51 to Column 2, line 5).
Fenton and Olsen in view of Murray are both considered to be analogous to the claimed invention because they are in the same field of ostomy bags. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Olsen in view of Murray to have the to incorporate the teachings of Fenton and have the EVA coating of Olsen in view of Murray to be a web of EVA, as taught by Fenton. This allows for the adhesive web to be breathable and microporous material which allow passage of water vapor from skin and avoid irritation of skin (Fenton; Column 1, line 51 to Column 2, line 5).
The combination of Olsen in view of Murray and Fenton does not expressly teach wherein the plurality of voids make up at least 50% of the web.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the plurality of voids make up at least 50% of the web since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the webbing of the adhesive would not operate differently with the claimed void percentage since the ostomy pouch is constructed with similar components and structure, more particularly the similar EVA material (see disclosed above) and is intended to secure two materials together with the same functionality of having a porous web of EVA on the layer of the pouch, which is understood to be less material than a full film of material. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the voids “may” be the given ranges (specification; page 5, lines 10-19).
Regarding claim 27, Olsen in view of Murray teaches the ostomy pouch of claim 1. The combination of Olsen in view of Murray does not teach wherein the coating is applied as a web comprising a mass and a plurality of voids.
However, Fenton teaches wherein the coating is applied as a web (coating of EVA adhesive is a web; Column 1, line 51 to Column 2, line 5 and Column 3, line 8-41) comprising a mass and a plurality of voids (obvious that an EVA web contains a mass and a plurality of voids; Column 1, line 51 to Column 2, line 5).
Fenton and Olsen in view of Murray are both considered to be analogous to the claimed invention because they are in the same field of ostomy bags. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Olsen in view of Murray to have the to incorporate the teachings of Fenton and have the EVA coating of Olsen in view of Murray to be a web of EVA, as taught by Fenton. This allows for the adhesive web to be breathable and microporous material which allow passage of water vapor from skin and avoid irritation of skin (Fenton; Column 1, line 51 to Column 2, line 5).
The combination of Olsen in view of Murray and Fenton does not expressly teach wherein the plurality of voids make up at least 50% of the web.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the plurality of voids make up at least 50% of the web since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the webbing of the adhesive would not operate differently with the claimed void percentage since the ostomy pouch is constructed with similar components and structure, more particularly the similar EVA material (see disclosed above) and is intended to secure two materials together with the same functionality of having a porous web of EVA on the layer of the pouch, which is understood to be less material than a full film of material. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the voids “may” be the given ranges (specification; page 5, lines 10-19).
Regarding claim 28, Olsen in view of Murray and Fenton teaches the pouch of claim 11. The combination of Olsen in view of Murray and Fenton does not expressly teach wherein the coating has a maximum thickness less than 0.05 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the coating with a maximum thickness of less than 0.05 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the webbing of the adhesive would not operate differently with the claimed thickness since the ostomy pouch is constructed with similar components and structure, more particularly the similar EVA material (see disclosed above) and is intended to secure two materials together with the same functionality of having a porous web of EVA on the layer of the pouch. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the voids “may” be the given ranges (specification; page 6, lines 6-10).
Regarding claim 29, Olsen in view of Murray and Fenton teaches the pouch of claim 11. The combination of Olsen in view of Murray and Fenton does not expressly teach wherein the coating has an average thickness less than 0.05 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the coating with an average thickness of less than 0.05 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the webbing of the adhesive would not operate differently with the claimed coating thickness since the ostomy pouch is constructed with similar components and structure, more particularly the similar EVA material (see disclosed above) and is intended to secure two materials together with the same functionality of having a porous web of EVA on the layer of the pouch. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the voids “may” be the given ranges (specification; page 6, lines 6-10).
Regarding claim 30, Olsen in view of Murray and Fenton teaches the pouch of claim 11. The combination of Olsen in view of Murray and Fenton does not expressly teach wherein the coating has an area density less than 35 g/m2.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the coating have an area density of less than 35 g/m2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the webbing of the adhesive would not operate differently with the claimed area density since the ostomy pouch is constructed with similar components and structure, more particularly the similar EVA material (see disclosed above) and is intended to secure two materials together with the same functionality of having a porous web of EVA on the layer of the pouch, which is understood to be less material than a full film of material. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the voids “may” be the given ranges (specification; page 6, lines 1-5).
Regarding claim 31, Olsen in view of Murray and Fenton teaches the pouch of claim 11. The combination of Olsen in view of Murray and Fenton does not expressly teach wherein the coating has an area density greater than 15 g/m2.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the coating have an area density of greater than 15 g/m2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the webbing of the adhesive would not operate differently with the claimed area density since the ostomy pouch is constructed with similar components and structure, more particularly the similar EVA material (see disclosed above) and is intended to secure two materials together with the same functionality of having a porous web of EVA on the layer of the pouch, which is understood to be less material than a full film of material. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the voids “may” be the given ranges (specification; page 6, lines 1-5).
Claim(s) 23 is rejected under 35 U.S.C. 103 as being unpatentable over Olsen et al. (Patent No. 6,336,918 B1) in view of Murray (Publication No. US 2016/0135983 A1), as applied to claim 1 above, and further in view of Smith et al. (Publication No. US 2011/0238024 A1), hereby referred to as “Smith ‘024”.
Regarding claim 23, Olsen in view of Murray teaches the pouch of claim 1. The combination of Olsen in view of Murray does not teach wherein the pouch further comprises a window opening for viewing the cavity wherein the window opening is arranged on the outer wall, the first sheet of comfort material comprising a first and second part, wherein the first part partially overlaps the second part, or the second part overlaps the first part in an overlap region to form the window opening.
However, Smith ‘024 teaches wherein the pouch further comprises a window opening for viewing the cavity wherein the window opening is arranged on the outer wall (opening on outer bag; Figures 7a and 7b; Paragraph 0059), the first sheet of comfort material comprising a first and second part (outer bag comprises first and second part at left and right side; Figure 7a and 7b), wherein the first part partially overlaps the second part, or the second part overlaps the first part in an overlap region to form the window opening (first part overlaps second part to form the window at 82; Figure 7a and 7b).
Olsen in view of Murray and Smith ‘024 are both considered to be analogous to the claimed invention because they are in the same field of ostomy bags. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Olsen in view of Murray to incorporate the teachings of Smith ‘024 and have the comfort layer of Olsen in view of Murray be in the first and second parts to form the window opening as taught by Smith ‘024. This allows for the opening to provide a water-tight closure while allowing for the user to view or access the pouch (Smith ‘024; Paragraph 0058-0059).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 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, Rebecca 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.
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.
/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781