DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
Claims 1-6, 9, 13, 15-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lysgaard (US 20170209297 A1).
Regarding Claim 1, Lysgaard teaches a drainable pouch (see Abstract), comprising:
a body side wall (rear wall 14) and a distal wall (front wall 12) joined along a portion of their peripheral edges to define a cavity therebetween for collecting body waste (the sidewalls 12 and 14 are joined along their edges as at 16 to define a cavity 18 there between, see Paragraph [0046]);
a downwardly extending outlet portion (neck portion 20) terminating in a discharge opening for draining body waste collected in the cavity (terminates in a discharge opening 22, see Figure 1A);
a closure member disposed at an end of the outlet portion (the bag can be closed by folding the neck portion 20), the closure member having a plurality of foldable members foldable upwardly toward the cavity to close the outlet portion (first and second plate 24 and 26), one or more of the foldable members having outwardly extending tabs (tabs 40, see Figures 1-2), ends of the plurality of foldable members being flexible inwardly to open the outlet portion (plates 24, 26 are attached to the opening 22 of the bag along the first edge portion 28, 30 enabling the plates to be pivoted, see Paragraph [0047]); and
at least one cover attached to one of the body side wall and distal side wall to overlie the plurality of foldable members when the foldable members are folded upwardly toward the cavity in a closed position (the front and/or rear walls of the bag may be provided with a cover layer, see Paragraph [0023]; after the folded neck portion is fixed by the strips it may be folded one more time and hidden behind the cover layer of the bag, see Figure 3 Paragraph [0051]).
Regarding Claim 2, Lysgaard further teaches wherein the extending tabs (40) comprise two tabs that extend past opposite outer edges of the outlet portion (extending past outer edges of neck portion 20, see Figures 1-2).
Regarding Claim 3, Lysgaard teaches all of the limitations as discussed above in claim 2 and Lysgaard further teaches wherein the two tabs extend from opposite sides of the outlet portion transverse to the outlet portion (tabs 40 extend from both sides transversely of neck 20, see Figures 1-2).
Regarding Claim 4, Lysgaard teaches all of the limitations as discussed above in claim 2 and Lysgaard further teaches wherein the two tabs are configured to aid in opening the outlet portion (the plates being able to pivot with respect to the neck portion enables them to be configured in a discharge configuration where the plates are lying towards the sidewalls such that a first surface of the plates are facing the surface of the neck portion (front and rear wall). see Paragraph [0021]).
Regarding Claim 5, Lysgaard teaches all of the limitations as discussed above in claim 2 and Lysgaard further teaches wherein the two tabs are located near the discharge opening (tabs 40 are located near discharge opening 22, see Figures 1-2).
Regarding Claim 6, Lysgaard teaches all of the limitations as discussed above in claim 2 and Lysgaard further teaches wherein the at least one cover comprises a first cover and a second cover, wherein the first cover is attached to the distal wall and the second cover is attached to the body side wall (the front and/or rear walls of the bag may be provided with a cover layer, see Paragraph [0023]).
Regarding Claim 9, Lysgaard teaches a drainable pouch (see Abstract), comprising: a body side wall (rear wall 14) and a distal wall (front wall 12) joined along a portion of their peripheral edges to define a cavity therebetween for collecting body waste (the sidewalls 12 and 14 are joined along their edges as at 16 to define a cavity 18 there between, see Paragraph [0046]); a downwardly extending outlet portion (neck portion 20) terminating in a discharge opening for draining body waste collected in the cavity (terminates in a discharge opening 22, see Figure 1A); and a closure member attached to the outlet portion (the bag can be closed by folding the neck portion 20), the closure member including a plurality of foldable members foldable upwardly toward the cavity to close the outlet portion (first and second plate 24 and 26), wherein one of the foldable members includes two tabs (tabs 40 for the first and second plates, see Figures 1-2) extending transversely past opposite outer edges of the outlet portion (see Figure 2) and configured to aid in opening the outlet portion (see Paragraph [0052]).
Regarding Claim 13, Lysgaard teaches a drainable pouch (see Abstract), comprising:
a body side wall (rear wall 14) and a distal wall (front wall 12) joined along a portion of their peripheral edges to define a cavity therebetween for collecting body waste (the sidewalls 12 and 14 are joined along their edges as at 16 to define a cavity 18 there between, see Paragraph [0046]);
a downwardly extending outlet portion (neck portion 20) terminating in a discharge opening for draining body waste collected in the cavity (terminates in a discharge opening 22, see Figure 1A); and
a closure member attached to the outlet portion (the bag can be closed by folding the neck portion 20), the closure member including a plurality of foldable members foldable upwardly toward the cavity to close the outlet portion (first and second plate 24 and 26), wherein one of the foldable members includes two tabs (tabs 40 for the first and second plates, see Figures 1-2) extending transversely past opposite outer edges of the outlet portion (see Figure 2) and configured to aid in opening the outlet portion (see Paragraph [0052]).
Regarding Claim 15, Lysgaard teaches all of the limitations as discussed above in claim 13 and Lysgaard further teaches wherein the two tabs are located near the discharge opening (tabs 40 are located near discharge opening 22, see Figures 1-2).
Regarding Claim 16, Lysgaard teaches all of the limitations as discussed above in claim 13 and Lysgaard further teaches at least one cover attached to one of the body side wall and distal side wall to overlie the outlet portion when the outlet portion is folded up in a closed position (the front and/or rear walls of the bag may be provided with a cover layer, see Paragraph [0023]; after the folded neck portion is fixed by the strips it may be folded one more time and hidden behind the cover layer of the bag, see Figure 3 Paragraph [0051]).
Regarding Claim 18, Lysgaard teaches all of the limitations as discussed above in claim 16 and Lysgaard further teaches wherein the at least one cover covers the two tabs when the outlet portion is folded up in the closed position (tabs 40 are folded up along with the neck portion 20; after the folded neck portion is fixed by the strips it may be folded one more time and hidden behind the cover layer of the bag, see Figure 3 Paragraph [0051]).
Claim Rejections - 35 USC § 103
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.
Claims 7-8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lysgaard (US 20170209297 A1) in view of Hoggarth et al. (AU 2020357918 A1), hereinafter referred to as “Hoggarth”.
Regarding Claim 7, Lysgaard teaches all of the limitations as discussed above in claim 2. However, Lysgaard does not explicitly disclose wherein the first and second covers include a first fastener and a second fastener to secure the first and second covers to one another.
Hoggarth teaches a drainable pouch (ostomy appliance 1, see Figures 9a-c) comprising: a body side wall (2) and a distal wall (3) joined along a portion of their peripheral edges to define a cavity therebetween for collecting body waste (see Figure 9a); and at least one cover attached to one of the body side wall (inner comfort layer 5) and distal side wall (outer comfort layer 6) to overlie the plurality of foldable members (retractable drain 40 may comprise a closure portion 202, see Figure 9c) when the foldable members are folded upwardly toward the cavity in a closed position (see Figure 9c), wherein the first and second covers include a first fastener (215a) and a second fastener (215b) to secure the first and second covers to one another (once the retractable drain 40 is in its retracted configuration the fastening element 215a, 215b may be secured together, as shown in Figure 9c).
Lysgaard and Hoggarth are analogous art because both disclose a drainable ostomy pouch.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first and second covers of Lysgaard and further include wherein the first and second covers include a first fastener and a second fastener to secure the first and second covers to one another, as taught by Hoggarth. Hoggarth teaches the cover with fasteners provide an increased cavity volume for the ostomy appliance while maintaining ostomate discretion and comfort (see Col. 2 lines 29-30).
Regarding Claim 8, Lysgaard and Hoggarth teach all of the limitations as discussed above in claim 7 and Lysgaard further teaches wherein the first and second covers secure the closure member when the closure member is in a closed position (the front and/or rear walls of the bag may be provided with a cover layer, see Paragraph [0023]; after the folded neck portion is fixed by the strips it may be folded one more time and hidden behind the cover layer of the bag, see Figure 3 Paragraph [0051]). Hoggarth further teaches the first and second cover members are fastened to one another (once the retractable drain 40 is in its retracted configuration the fastening element 215a, 215b may be secured together, as shown in Figure 9c).
Regarding Claim 17, Lysgaard teaches all of the limitations as discussed above in claim 16 and Lysgaard further teaches wherein the at least one cover comprises a first cover and a second cover, wherein the first cover is attached to the distal wall and the second cover is attached to the body side wall (the front and/or rear walls of the bag may be provided with a cover layer, see Paragraph [0023]).
However, Lysgaard does not explicitly disclose wherein the first and second covers include a first fastener and a second fastener to secure the first and second covers to one another.
Hoggarth teaches a drainable pouch (ostomy appliance 1, see Figures 9a-c) comprising: a body side wall (2) and a distal wall (3) joined along a portion of their peripheral edges to define a cavity therebetween for collecting body waste (see Figure 9a); and at least one cover attached to one of the body side wall (inner comfort layer 5) and distal side wall (outer comfort layer 6) to overlie the plurality of foldable members (retractable drain 40 may comprise a closure portion 202, see Figure 9c) when the foldable members are folded upwardly toward the cavity in a closed position (see Figure 9c), wherein the first and second covers include a first fastener (215a) and a second fastener (215b) to secure the first and second covers to one another (once the retractable drain 40 is in its retracted configuration the fastening element 215a, 215b may be secured together, as shown in Figure 9c).
Lysgaard and Hoggarth are analogous art because both disclose a drainable ostomy pouch.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first and second covers of Lysgaard and further include wherein the first and second covers include a first fastener and a second fastener to secure the first and second covers to one another, as taught by Hoggarth. Hoggarth teaches the cover with fasteners provide an increased cavity volume for the ostomy appliance while maintaining ostomate discretion and comfort (see Col. 2 lines 29-30).
Claims 10-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lysgaard (US 20170209297 A1) in view of Weinberg et al. (WO 2018136793 A1), hereinafter referred to as “Weinberg”.
Regarding Claim 10, Lysgaard teaches all of the limitations as discussed above in claim 1. However, Lysgaard does not explicitly disclose wherein the closure member includes at least one transversely-extending fold-line configured to facilitate folding up the closure member.
Weinberg teaches a drainable pouch (10, see Abstract; Figure 1), comprising: a body side wall (bodyside wall 14) and a distal wall (distal wall 12 joined along a portion of their peripheral edges to define a cavity therebetween for collecting body waste (see Paragraph [0035]); a closure member disposed at an end of an outlet portion (a single-piece closure member 22 on a distal surface of the outlet portion 18, see Paragraph 0037]), the closure member having a plurality of foldable members foldable upwardly toward the cavity to close the outlet portion (closure member 22 can be folded upward to the cavity, see Paragraph [0037]; Figure 4), wherein the closure member includes at least one transversely-extending fold-line configured to facilitate folding up the closure member (transversely-extending fold-lines 24, 26 for closure, see Figure 1).
Lysgaard and Weinberg are analogous art because both disclose a drainable ostomy pouch.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the closure member of Lysgaard and further include wherein the closure member includes at least one transversely-extending fold-line configured to facilitate folding up the closure member, as taught by Weinberg. Weinberg teaches by configuring the closure system into a sing-piece closure member, required folding tolerances for a liquid-tight seal of an outlet may be built into the transversely- extending fold-lines in the single-piece closure member. Thus, a relatively complex assembly process requiring a high tolerance placement of multiple closure members may be eliminated, rendering a simplified assembly (see Paragraph [0058]).
Regarding Claim 11, Lysgaard teaches all of the limitations as discussed above in claim 1. However, Lysgaard does not explicitly disclose wherein the closure member further includes one or more vertically-extending fold lines and/or angled fold lines to facilitate opening the closure member and outlet portion to empty the drainable pouch.
Weinberg teaches a drainable pouch (10, see Abstract; Figure 1), comprising: a body side wall (bodyside wall 14) and a distal wall (distal wall 12 joined along a portion of their peripheral edges to define a cavity therebetween for collecting body waste (see Paragraph [0035]); a closure member disposed at an end of an outlet portion (a single-piece closure member 22 on a distal surface of the outlet portion 18, see Paragraph 0037]), the closure member having a plurality of foldable members foldable upwardly toward the cavity to close the outlet portion (closure member 22 can be folded upward to the cavity, see Paragraph [0037]; Figure 4), wherein the closure member further includes one or more vertically-extending fold lines and/or angled fold lines to facilitate opening the closure member and outlet portion to empty the drainable pouch (the one-piece closure member 22 may include two parallel axially-extending fold-lines 28, 30; to open the discharge opening 20, a user may apply pressure along axially-extending peripheral edges of the outlet portion 18 to fold the one-piece closure member 22 along the axially-extending fold-lines 28, 30, see Paragraph [0043]; Figure 2).
Lysgaard and Weinberg are analogous art because both disclose a drainable ostomy pouch.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the closure member of Lysgaard and further include wherein the closure member further includes one or more vertically-extending fold lines and/or angled fold lines to facilitate opening the closure member and outlet portion to empty the drainable pouch, as taught by Weinberg. Weinberg teaches by configuring the closure system into a sing-piece closure member, required folding tolerances for a liquid-tight seal of an outlet may be built into the transversely- extending fold-lines in the single-piece closure member. Thus, a relatively complex assembly process requiring a high tolerance placement of multiple closure members may be eliminated, rendering a simplified assembly (see Paragraph [0058]).
Regarding Claim 12, Lysgaard teaches all of the limitations as discussed above in claim 1. However, Lysgaard does not explicitly disclose wherein the closure member includes at least one transversely-extending fold-line configured to facilitate folding up the closure member and at least one vertically-extending and/or angled fold line configured to facilitate opening of the outlet portion, wherein the at least one transversely-extending fold-line and the at least one vertically-extending and/or angled fold line are configured to facilitate bi-directional manipulation of the closure member.
Weinberg teaches wherein the closure member includes at least one transversely-extending fold-line configured to facilitate folding up the closure member (transversely-extending fold-lines 24, 26 for closure, see Figure 1) and at least one vertically-extending and/or angled fold line configured to facilitate opening of the outlet portion (to open the discharge opening 20, a user may apply pressure along axially-extending peripheral edges of the outlet portion 18 to fold the one-piece closure member 22 along the axially-extending fold-lines 28, 30, see Paragraph [0043]), wherein the at least one transversely-extending fold-line and the at least one vertically-extending and/or angled fold line are configured to facilitate bi-directional manipulation of the closure member (the transversely- extending fold-lines 24, 26 and the axially-extending fold-lines 28, 30 may provide two axis of manipulation including a transverse axis for folding and sealing, see Paragraph [0044]).
Lysgaard and Weinberg are analogous art because both disclose a drainable ostomy pouch.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the closure member of Lysgaard and further include wherein the closure member includes at least one transversely-extending fold-line configured to facilitate folding up the closure member and at least one vertically-extending and/or angled fold line configured to facilitate opening of the outlet portion, wherein the at least one transversely-extending fold-line and the at least one vertically-extending and/or angled fold line are configured to facilitate bi-directional manipulation of the closure member, as taught by Weinberg. Weinberg teaches by configuring the closure system into a sing-piece closure member, required folding tolerances for a liquid-tight seal of an outlet may be built into the transversely- extending fold-lines in the single-piece closure member. Thus, a relatively complex assembly process requiring a high tolerance placement of multiple closure members may be eliminated, rendering a simplified assembly (see Paragraph [0058]).
Regarding Claim 14, Lysgaard teaches all of the limitations as discussed above in claim 13. However, Lysgaard does not explicitly disclose wherein the closure member includes at least one transversely-extending fold-line configured to facilitate folding up the closure member and at least one vertically-extending and/or angled fold line configured to facilitate opening of the outlet portion, wherein the at least one transversely-extending fold-line and the at least one vertically-extending and/or angled fold line are configured to facilitate bi-directional manipulation of the closure member.
Weinberg teaches wherein the closure member includes at least one transversely-extending fold-line configured to facilitate folding up the closure member (transversely-extending fold-lines 24, 26 for closure, see Figure 1) and at least one vertically-extending and/or angled fold line configured to facilitate opening of the outlet portion (to open the discharge opening 20, a user may apply pressure along axially-extending peripheral edges of the outlet portion 18 to fold the one-piece closure member 22 along the axially-extending fold-lines 28, 30, see Paragraph [0043]), wherein the at least one transversely-extending fold-line and the at least one vertically-extending and/or angled fold line are configured to facilitate bi-directional manipulation of the closure member (the transversely- extending fold-lines 24, 26 and the axially-extending fold-lines 28, 30 may provide two axis of manipulation including a transverse axis for folding and sealing, see Paragraph [0044]).
Lysgaard and Weinberg are analogous art because both disclose a drainable ostomy pouch.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the closure member of Lysgaard and further include wherein the closure member includes at least one transversely-extending fold-line configured to facilitate folding up the closure member and at least one vertically-extending and/or angled fold line configured to facilitate opening of the outlet portion, wherein the at least one transversely-extending fold-line and the at least one vertically-extending and/or angled fold line are configured to facilitate bi-directional manipulation of the closure member, as taught by Weinberg. Weinberg teaches by configuring the closure system into a sing-piece closure member, required folding tolerances for a liquid-tight seal of an outlet may be built into the transversely- extending fold-lines in the single-piece closure member. Thus, a relatively complex assembly process requiring a high tolerance placement of multiple closure members may be eliminated, rendering a simplified assembly (see Paragraph [0058]).
Conclusion
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/ERIC RASSAVONG/ (8/8/2026)Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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