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 Objections
Claims 1 and 14 are objected to because of the following informalities:
Claim 1 recites “the coupler through-hole” in lines 6-7 and should be “a coupler through-hole”. Appropriate correction is required.
Claim 2 recites “a coupler through-hole” in lines 2-3 and should be “the coupler through-hole”. Appropriate correction is required.
Claim 14 recites “the ostomy bag” in line 9 and should be “an ostomy bag”. Appropriate correction is required.
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.
Claims 1-5, 8-9, 14-18, 20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 20220202606 A1), hereinafter referred to as “”Jones” in view of Kilgour (WO 9323229 A1).
Regarding Claim 1, Jones teaches a coupler assembly for an ostomy appliance (see Abstract), comprising:
a side coupler (flange 126) defining a female receiver having a locking rim (portion configured to hold male portion of coupler 116, see Figure 1c),
a side coupler (116) defining a male portion having a locking shelf (124) and sized to be selectively coupled to the female receiver (coupled to female portion of flange 126, see Figure 1c),
a deflectable seal (122) defined about the male portion at a radially inward location from the coupler through-hole relative to the locking shelf (deflectable seal 122 defined from the coupler 116 and is radially inward relative to shelf 124, see Figure 1c); and
a seal wall defined in the female receiver wherein the deflectable seal contacts the seal wall to substantially seal an interior of the ostomy bag from the surrounding environment when the male portion is coupled to the female receiver (deflectable seal 122 of the side flange 116 may correspond with an adjacent surface in the recess of the side flange 126 to substantially seal the side flange 126 and the corresponding to the side flange 116, see Paragraph [0046]);
wherein, when the male portion is coupled to the female receiver (see Figure 1c), providing a pulling force on the ostomy bag increases a decoupling force required to uncouple the male portion from the female receiver by biasing the locking rim and locking shelf towards one another (flanges 116, 126 are coupled to one another to resist uncoupling under expected forces such as the user moving around when the corresponding bag has fluid therein, see Paragraph [0045]).
However, Jones does not explicitly disclose a body side coupler, the body side coupler configured to be selectively coupled to a user and a bag side coupler, the bag side coupler configured to be coupled to an ostomy bag.
Kilgour teaches a coupler assembly for an ostomy appliance (see Abstract; Figure 6-10) comprising: a body side coupler (body side coupling element 160); a bag side coupler (bag side coupling element 110); and a deflectable seal defined about the male portion (flexible deflectable seal strip 168), wherein the body side coupler configured to be selectively coupled to a user (body side coupler 160) and the bag side coupler configured to be coupled to an ostomy bag (bag side coupling element 110) (the coupling element shown in Figure 6 will be the bag-side element and that shown in Figure 10 will be the body side element, but these elements may be reversed, see pg. 13 last paragraph - pg. 14 first paragraph).
Jones and Kilgour are analogous art because both disclose a coupler assembly for an ostomy appliance.
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 side couplers of Jones and further include one for them to be reversible for a body side and bag side, as taught by Kilgour. Kilgour teaches this reversible configuration is beneficial to provide the possibility for the use of more flexible side walls for the coupling element, enabling a lower application force to be used whilst providing a high degree of security by the use of an undercut formation with a steep angle of slope relative to the axis of the ostomy coupling element (see pg. 9 last paragraph).
Regarding Claim 2, Jones and Kilgour teach all of the limitations of claim 1 and Jones further teaches wherein the ostomy bag is coupled to the bag side coupler at a location radially outward of the locking shelf relative to a coupler through-hole (bag side flange 126 may typically have a corresponding bag coupled around the opening 120, see Paragraph [0043]; Figure 1c).
Regarding Claim 3, Jones and Kilgour teach all of the limitations of claim 2 and Jones further teaches wherein the body side coupler is coupled to a bridging ring at a location radially inward from the locking rim relative to the coupler through- hole (bridging ring 316 may be coupled to an adhesive 320 that is configured to be coupled to a patient's abdominal wall 322, see Paragraph [0051]; the coupling assembly 300 otherwise substantially functions the same as the coupling assembly 100, see Paragraph [0051]; Figure 3c).
Regarding Claim 4, Jones and Kilgour teach all of the limitations of claim 1 and Jones further teaches an accordion membrane defined in the body side coupler (element 306 having an accordion membrane 302, see Figure 3c; Paragraph [0049]) between the female receiver and a bridging ring weld (between female receiver and bridging ring weld 318, see Paragraph [0051]).
Regarding Claim 5, Jones and Kilgour teach all of the limitations of claim 4 and Jones further teaches wherein the female receiver and the accordion membrane are formed of the same material in the same manufacturing process (body side flange 304 and accordion membrane 302 of the integrated element 306 are formed from substantially from the same material in a single manufacturing process, see Paragraph [0050]).
Regarding Claim 8, Jones and Kilgour teach all of the limitations of claim 1 and Jones further teaches a bridging ring coupled to the body side coupler on a first side (bridging ring 316 coupled to component 306, see Figure 4c; Paragraph [0051]) and having an adhesive on a second side (bridging ring 316 coupled to an adhesive 320, see Paragraph [0051]), the adhesive configured to be selectively coupled to a user's abdominal wall about a stoma (adhesive 320 that is configured to be coupled to a patient's abdominal wall 322, see Paragraph [0051]; coupled to a stoma, see Paragraph [0046] and [0051]).
Regarding Claim 9, Jones and Kilgour teach all of the limitations of claim 1 and Jones further teaches wherein the body side coupler is formed of polyethylene (the material injected into the mold to form the integrated element 306 may be a low-density polyethylene, see Paragraph [0058]).
Regarding Claim 14, Jones teaches A method of manufacturing a coupler assembly for an ostomy appliance (manufacturing process for a coupling assembly, see Abstract), comprising:
forming a side coupler (flange 126) that defines a female receiver having a locking rim (portion configured to hold male portion of coupler 116, see Figure 1c);
forming a side coupler (116) that defines a male portion having a locking shelf (124), the male portion sized to be selectively coupled to the female receiver (coupled to female portion of flange 126, see Figure 1c);
forming a deflectable seal (122) in the male portion at a radially inward location from a coupler through-hole relative to the locking shelf (deflectable seal 122 defined from the coupler 116 and is radially inward relative to shelf 124, see Figure 1c);
forming a seal wall in the female receiver wherein the deflectable seal contacts the seal wall to substantially seal an interior of an ostomy bag from the surrounding environment when the male portion is coupled to the female receiver (deflectable seal 122 of the side flange 116 may correspond with an adjacent surface in the recess of the side flange 126 to substantially seal the side flange 126 and the corresponding to the side flange 116, see Paragraph [0046]);
coupling the body side coupler to a bridging ring (bridging ring 316 may be coupled to an adhesive 320 that is configured to be coupled to a patient's abdominal wall 322, see Paragraph [0051]; the coupling assembly 300 otherwise substantially functions the same as the coupling assembly 100, see Paragraph [0051]; Figure 3c);
wherein, the male portion is coupleable to the female receiver in a coupled configuration (see Figure 1c) wherein providing a pulling force on the ostomy bag increases a decoupling force required to uncouple the male portion from the female receiver by biasing the locking rim towards the locking shelf (flanges 116, 126 are coupled to one another to resist uncoupling under expected forces such as the user moving around when the corresponding bag has fluid therein, see Paragraph [0045]).
However, Jones does not explicitly disclose a body side coupler, the body side coupler configured to be selectively coupled to a user and a bag side coupler, the bag side coupler configured to be coupled to an ostomy bag.
Kilgour teaches a coupler assembly for an ostomy appliance (see Abstract; Figure 6-10) comprising: a body side coupler (body side coupling element 160); a bag side coupler (bag side coupling element 110); and a deflectable seal defined about the male portion (flexible deflectable seal strip 168), wherein the body side coupler configured to be selectively coupled to a user (body side coupler 160) and the bag side coupler configured to be coupled to an ostomy bag (bag side coupling element 110) (the coupling element shown in Figure 6 will be the bag-side element and that shown in Figure 10 will be the body side element, but these elements may be reversed, see pg. 13 last paragraph - pg. 14 first paragraph).
Jones and Kilgour are analogous art because both disclose a coupler assembly for an ostomy appliance.
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 side couplers of Jones and further include one for them to be reversible for a body side and bag side, as taught by Kilgour. Kilgour teaches this reversible configuration is beneficial to provide the possibility for the use of more flexible side walls for the coupling element, enabling a lower application force to be used whilst providing a high degree of security by the use of an undercut formation with a steep angle of slope relative to the axis of the ostomy coupling element (see pg. 9 last paragraph).
Regarding Claim 15, Jones and Kilgour teach all of the limitations of claim 14 and Jones further teaches forming an accordion membrane (element 306 having an accordion membrane 302, see Figure 3c; Paragraph [0049]) in the body side coupler between the female receiver and the bridging ring between the female receiver and a bridging ring weld (between female receiver and bridging ring 316 via weld 318, see Paragraph [0051]).
Regarding Claim 16, Jones and Kilgour teach all of the limitations of claim 15 and Jones further teaches forming the female receiver and the accordion membrane in the same manufacturing step (body side flange 304 and accordion membrane 302 of the integrated element 306 are formed from substantially from the same material in a single manufacturing process, see Paragraph [0050]).
Regarding Claim 17, Jones and Kilgour teach all of the limitations of claim 15 and Jones further teaches wherein the coupling the body side coupler to the bridging ring step comprises welding a portion of the accordion membrane to the bridging ring along a bridging ring weld (the integrated component 306 may be coupled to a bridging ring 316 via a weld 318, see Paragraph [0051]).
Regarding Claim 18, Jones and Kilgour teach all of the limitations of claim 14 and Jones further teaches coupling an adhesive to the bridging ring to selectively couple the body side coupler to a user's abdominal wall (adhesive 320 that is configured to be coupled to a patient's abdominal wall 322; coupled to a stoma, see Paragraph [0046] and [0051]; wherein the bridging ring 316 is coupled to an adhesive 320, see Paragraph [0051]).
Regarding Claim 20, Jones and Kilgour teach all of the limitations of claim 14 and Jones further teaches wherein the locking rim and locking shelf correspond with one another to substantially maintain the body side coupler and the bag side coupler in the coupled configuration (flanges 116, 126 are coupled to one another to resist uncoupling under expected forces such as the user moving around when the corresponding bag has fluid therein, see Paragraph [0045]).
Regarding Claim 22, Jones and Kilgour teach all of the limitations of claim 14 and Jones further teaches wherein the deflectable seal (122) is positioned to provide a biasing force of the locking shelf towards the locking rim to maintain the coupled configuration (when the flanges 116, 126 are in the substantially locked configuration, the deflectable seal 122 is positioned against the corresponding surface of the bag side flange 126 and thereby seals the flanges 116, 126 to one another about the opening 120).
Regarding Claim 23, Jones and Kilgour teach all of the limitations of claim 14 and Jones further teaches wherein the body side coupler and bag side coupler are formed from an injection molding process (In one example of this embodiment the single manufacturing process is an injection molding process, see Paragraph [0016]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jones and Kilgour as applied to claim 9 above, and further in view of Steer et al. (US 5830200 A), hereinafter referred to as “Steer”.
Regarding Claim 10, Jones and Kilgour teach all of the limitations of claim 9. However, Jones and Kilgour do not explicitly disclose wherein the bag side coupler is formed of EVA.
Steer teaches a coupler assembly for an ostomy appliance (see Abstract) comprising: a body side coupler (first coupling 50); and a bag side coupler (second coupling 60), wherein the bag side coupler is formed of EVA (The second coupling member may also be a plastics molding, e.g. of EVA, see Col. 2 lines 56-57).
Jones, Kilgour, and Steer are analogous art because all teach a coupler assembly for an ostomy appliance.
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 bag side coupler of Modified Jones and further include wherein the bag side coupler is formed of EVA, as taught by Steer. Steer teaches it desirable to have improved designs of ostomy couplings which embody a springy or resilient split ring as a locking ring (see Abstract).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Jones and Kilgour as applied to claim 1 above, and further in view of Van Der et al. (EP 1894547 A1), hereinafter referred to as “Van Der”.
Regarding Claim 11, Jones and Kilgour teach all of the limitations of claim 1. However, Jones and Kilgour do not explicitly disclose wherein the female receiver of the body side coupler is welded directly to a wafer.
Van Der teaches a coupler assembly for an ostomy appliance comprising: a body side coupler having a female receiver (flange surface 4), wherein the female receiver of the body side coupler is welded directly to a wafer (flange surface 4 welded on top of a hydrocolloid wafer, see Paragraph [0009]; Figure 9).
Jones, Kilgour, and Van Der are analogous art because all teach a coupler assembly for an ostomy appliance.
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 bag side coupler of Modified Jones and further include wherein the female receiver of the body side coupler is welded directly to a wafer, as taught by Van Der. Van Der teaches the body side coupler is welded directly to a wafer is beneficial to allow both the attachment and removal of pouches without burdening the sensitive or weak peristomal skin. In order to reduce the problems with the pressure forces when attaching a pouch of a 2-piece system on a sensitive or weak abdomen (see Paragraph [0004]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Jones and Kilgour as applied to claim 1 above, and further in view of Brandt et al. (US 20150173938 A1), hereinafter referred to as “Brandt”.
Regarding Claim 12, Jones and Kilgour teach all of the limitations of claim 1 and Jones further teaches a flange defined by the bag side coupler extending radially outward relative to a coupler through-hole (flange extending radially outward relative to a coupler through hole, see Figure 4b-c) the ostomy bag being attached to the bag side coupler along a surface of the flange (bag side flange 314, and the corresponding bag, see Paragraph [0051]).
However, Jones and Kilgour do not explicitly disclose the ostomy bag being welded to the bag side coupler along a surface of the flange.
Brandt teaches a coupler assembly for an ostomy appliance (see Abstract) comprising: a bag side coupler (a flange 4), an ostomy bag being welded to the bag side coupler along a surface of the flange (the bag and sheath are welded to the flange, see Paragraph [0015]).
Jones, Kilgour, and Brandt are analogous art because all teach a coupler assembly for an ostomy appliance.
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 connection between the ostomy bag and bag side coupler flange of Modified Jones and further include the ostomy bag being welded to the bag side coupler along a surface of the flange, as taught by Brandt. Brandt teaches it is beneficial for an ostomy bag equipped with means for simple closing and sealing of the contents of the bag and which means can maintain the seal after the bag has been detached from the body of the patient thereby reducing the risk of escaping odor or soiling of the clothing by dripping output from the stoma (see Paragraph [0007]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Jones and Kilgour as applied to claim 1 above, and further in view of Blum (EP 0479573 A1).
Regarding Claim 13, Jones and Kilgour teach all of the limitations of claim 1. However, Jones and Kilgour do not explicitly disclose wherein the female receiver of the body side coupler has a convex flange that is offset from a planar surface of the female receiver.
Blum teaches a coupler assembly for an ostomy appliance (see Abstract) comprising: a body side coupler (insert D, see Figures 2-5), wherein the female receiver of the body side coupler has a convex flange that is offset from a planar surface of the female receiver (a convex annular body 46 offset of the planar center female portion, see Figure 5).
Jones, Kilgour, and Blum are analogous art because all teach a coupler assembly for an ostomy appliance.
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 female receiver of the body side coupler of Modified Jones and further include wherein the female receiver of the body side coupler has a convex flange that is offset from a planar surface of the female receiver, as taught by Blum. Blum teaches is beneficial for a better seal between the peristomal stoma skin and the faceplate results. Further, a normally non-protruding stoma will be caused to protrude further into the stoma receiving opening. Hence, in some patients, it is desirable to utilize a faceplate with a convex curvature (see Col. 2 paragraph 2).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Jones and Kilgour as applied to claim 1 above, and further in view of Edwards et al. (EP 0463359 A2), hereinafter referred to as “Edwards”.
Regarding Claim 19, Jones and Kilgour teach all of the limitations of claim 14. However, Jones and Kilgour do not explicitly disclose welding the ostomy bag to a flange formed in the bag side coupler along a bag weld.
Edwards teaches a coupler assembly for an ostomy appliance (see Abstract), comprising: a bag side coupler (coupling ring D') and a welding the ostomy bag to a flange formed in the bag side coupler along a bag weld (coupling rings C and D may be affixed to the pouch B and faceplate A respectively by welding, adhesives or other conventional affixation means appropriate for plastic elements, see Col. 6 lines 49-52).
Jones, Kilgour, and Edwards are analogous art because all teach a coupler assembly for an ostomy appliance.
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 ostomy bag flange formed in the bag side coupler of Modified Jones and further include welding the ostomy bag to a flange formed in the bag side coupler along a bag weld, as taught by Edwards. Edwards teaches it is beneficial for a pouch coupling ring structure which substantially reduces the required coupling force to facilitate mounting of the pouch and a faceplate coupling ring structure which substantially increases the required uncoupling force to enhance security (see Col. 1 paragraph 1).
Conclusion
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/ERIC RASSAVONG/ (8/8/2026)Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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