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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/06/26 has been entered.
Response to Amendment
Applicant amended claims 1, 3, 6, 22-23, 33, and 35-36, added claim 43, and canceled claim 16. Claims 1, 3, 6, 9, 11, 18, 22-24, 29, 31-33, 35-37, 39, and 43.
Response to Arguments
Applicant’s arguments, see page 7 of Applicant’s Remarks, filed 03/10/26, with respect to the rejection of claims 22-24 under 35 U.S.C. 112(d) have been fully considered and are persuasive in light of the amendments. Therefore, the rejections have been withdrawn.
Applicant’s arguments, see pages 8-12, with respect to the rejections of claims 1, 3, 16, 18, 22, 29, 33, 35, 37, and 39 under 35 U.S.C. 102(a)(1) as anticipated by Eskaros, of claims 6 and 36 under 35 U.S.C. 103 as unpatentable over Eskaros in view of Burton and in further view of Millis, of claim 9 in further view of Andersen, of claim 11 over Eskaros in view of Tsai, in further view of Burton, and in further view of Schertiger, of claim 23 over Eskaros in view of Hanuka, of claim 24 in further view of Millis, of claim 31 over Eskaros in view of Schena and in further view of Masters, and of claim 32 over Eskaros in view of Edvardsen have been fully considered and are persuasive in light of the amendments. Therefore, the rejections have been withdrawn. However, upon further search and consideration, new grounds of rejection have been made as indicated below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 36 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 36 recites the limitation "said connecting sleeve" in line 2. There is insufficient antecedent basis for this limitation in the claim because neither claims 33 nor 35, which claim 36 is directly or indirectly dependent on, recite a connecting sleeve. Claim 35 was amended to remove language describing “a hollow connecting sleeve” connecting the proximal and distal edges, and claim 33 recites “a hollow sleeve connecting said proximal … edge and said … distal edge”. Therefore, the “connecting sleeve” of claim 36 was interpreted to be the same as the hollow sleeve recited in claim 33 for the purpose of examination.
Claim 36 also recites the limitation “the ostomy draining device” in line 6. There is insufficient antecedent basis for this limitation in the claim because neither claims 33 nor 35 recite an ostomy draining device. Claims 33 and 35 recites an “ostomy draining conduit”, and claim 36 was interpreted as though it recites “the ostomy draining conduit” in line 6 for the purpose of examination.
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 33 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cline et al. (US 2010/0174253 A1).
Regarding claim 33, Cline discloses an ostomy draining/disposing conduit (Figs. 1-4C and 10A-10C, feat. 20; ¶0008-0012, 0079-0090, and 0101-0104) comprising: a proximal self-expanding internal sealing edge (Figs. 10A-10B, feat. 64; Fig. 10C, feats. 56, 68; ¶0101-0104: internal sealing edge may comprise a foam ring 64 or a bolster 56 enclosing a foam ring 68) configured to be inserted into a stoma (Fig. 10A, feat. 10; ¶0079 and 0101) and sealing passage between the conduit’s exterior wall and the stoma’s interior wall (¶0101-0102); a distal external draining edge (Figs. 2A-4C and 10A, feat. 24; ¶0079-0090), wherein when inserted into the stoma, the distal external draining edge allows passage of liquid and stool while preventing passage between the conduit’s exterior wall and the stoma’s interior wall (i.e. prevents leakage) (Figs. 2A-3B, feat. 38; Figs. 4A-4C, feat. 46; ¶0084-0088: distal end 24 comprises a flange 38 or mating ring 46 to engage body fitment 32 which directly transports effluent from the body into a receiving pouch without exposing the peristomal skin tissue), a hollow sleeve connecting said proximal self-expanding internal sealing edge and said distal external draining edge (Figs. 2A-4C and 10A-10C, feat. 20); wherein: (i) the proximal self-expanding internal sealing edge’ diameter is smaller than an user intestine’s diameter (Figs. 10A-10C; ¶0101-0104: the internal sealing edge bears and seals against the bowel wall 52, and therefore has a smaller diameter than it); and (ii) the proximal self-expanding internal sealing edge is self-collapsible, such that it can be modified/re-shaped during insertion thereof into the stoma and return to its original shape once inserted into the stoma (¶0102-0103: the foam at the proximal end is elastic, and is therefore collapsible and expandable).
Regarding claim 39, Cline discloses the conduit of claim 33 and further discloses that said proximal self-expanding internal sealing edge is self-collapsible, such that it can be modified/re-shaped during insertion thereof into the stoma and return to its original shape once inserted into the stoma (¶0102-0103: the foam at the proximal end is elastic, and is therefore collapsible and expandable).
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.
Claims 1, 3, 22-23, 29, 35-37, 39, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Cline in view of McMichael (US 2006/0052752 A1).
Regarding claim 1, Cline discloses an ostomy draining device (Figs. 1-4C and 10A-10C, feat. 20; ¶0008-0012, 0079-0090, and 0101-0104) comprising: an ostomy draining/disposing conduit (20), said conduit comprising: a proximal internal sealing edge (Figs. 10A-10B, feat. 64; Fig. 10C, feats. 56, 68; ¶0101-0104: internal sealing edge may comprise a foam ring 64 or a bolster 56 enclosing a foam ring 68) designed to be inserted into a stoma (Fig. 10A, feat. 10; ¶0079 and 0101) and sealing passage between the conduit’s exterior wall and the stoma’s interior wall (¶0101-0102), the proximal internal sealing edge configured to self-expand (¶0103); and a distal external draining edge (Figs. 2A-4C and 10A, feat. 24; ¶0079-0090), wherein when inserted into the stoma allows passage of liquid and stool while preventing passage between the conduit’s exterior wall and the stoma’s interior wall (Figs. 2A-3B, feat. 38; Figs. 4A-4C, feat. 46; ¶0084-0088: distal end 24 comprises a flange 38 or mating ring 46 to engage body fitment 32 which directly transports effluent from the body into a receiving pouch without exposing the peristomal skin tissue), a hollow sleeve connecting said proximal self-expanding internal sealing edge and said distal external draining edge (Figs. 2A-4C and 10A-10C, feat. 20); a body attachment baseplate configured to attach said ostomy device to an ostomate, said baseplate comprising a stoma-bag adapter flange (Fig. 1, feats. 28, 30, 32; Figs. 2A-3B, feats. 24 and 32; Figs. 4A-4C, feats. 24 and 32; ¶0079-0090: body fitment 32 is attached to an ostomy appliance 28 comprising a collection pouch/bag 30 and also engages the distal edge 24 of the device 20), wherein: (i) the proximal self-expanding internal sealing edge’ diameter is smaller than an intestine’s diameter (Figs. 10A-10C; ¶0101-0104: the internal sealing edge bears and seals against the bowel wall 52, and therefore has a smaller diameter than it); and (ii) the proximal self-expanding internal sealing edge is self-collapsible, such that it can be modified/re-shaped during insertion thereof into the stoma and return to its original shape once inserted into the stoma (¶0102-0103: the foam at the proximal end is elastic, and is therefore collapsible and expandable).
Cline does not disclose an external membrane mounted onto said hollow sleeve, wherein movement of said external membrane towards the expanding internal sealing edge creates a sealing axial force to affix said conduit in place.
McMichael teaches a stoma device (Figs. 1-5, feat. 10; ¶0028) comprising a first internal bolster (14; ¶0028 and 0030), a second external bolster (30; ¶0031), and a tube (12; ¶0028), which respectively correspond to the proximal internal sealing edge, the flange or mating ring connecting the distal external draining edge to the body fitment, and conduit/hollow sleeve of the device disclosed by Cline. The second external bolster (Figs. 1 and 4-5, feat. 30) engages protruding grooves or threads on the outer surface (22) of the tube (12) with a membrane or spring clip (41), which permits easy one-way advancement of the second external bolster towards the first internal bolster to sandwich the abdominal wall between the two bolsters (¶0031). McMichael teaches that this advantageously allows the tube to be secured in place with a snug but not too tight fit, while also allowing the external bolster to be further advanced if necessary, such as if swelling around the stoma site decreases (¶0031 and 0039). Modifying the device of Cline so that the conduit/hollow sleeve of Cline has grooves or threads on the outer surface like the tube of McMichael and so that the flange or mating ring of Cline has a membrane or spring clip for attaching to the tube like the one taught by McMichael would advantageously allow the fit of the device to be easily tightened if necessary as taught by McMichael. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device disclosed by Cline to include an external membrane mounted onto said hollow sleeve, wherein movement of said external membrane along the sleeve towards the expanding internal sealing edge creates a sealing axial force to affix said conduit in place in order to allow the fit of the device to be easily tightened if necessary as taught by McMichael.
Regarding claim 3, Cline in view of McMichael suggests the device of claim 1. Cline further discloses that the hollow sleeve (20) may be made of elastic, flexible materials which can deform or collapse and regain their original shape (Cline: ¶0092-0094). As discussed above, McMichael teaches that the tube corresponding to the hollow sleeve and conduit (McMichael: Figs. 1-5, feat. 12) should be long enough to sandwich the abdominal wall (McMichael: 40) between the first internal bolster (McMichael: 14) and the second external bolster (McMichael: 30; ¶0031). McMichael further teaches that the length of the tube may be shortened, and therefore adjusted, as necessary by the clinician (McMichael: ¶0032). Therefore, Cline in view of McMichael further suggests that the hollow sleeve’s length is longer than an abdomen wall’s thickness, wherein said hollow sleeve comprises a region that is self-collapsible, thereby preventing unintentional damage to the stoma’s walls during insertion of the conduit into the stoma, and wherein the length of the ostomy draining conduit is optionally adjustable.
Regarding claim 22, Cline in view of McMichael suggests the device of claim 1, and Cline further discloses said conduit comprises a flexible polymeric sleeve made of degradable polymer (Figs. 17-18, feat. 102; ¶0027-0028 and 0118-0122: constricting or retaining member 102 may be cylindrical).
Regarding claim 23, Cline in view of McMichael suggests the device of claim 1, and Cline further discloses a detachable applicator for inserting the conduit into the stoma (Fig. 17, feat. 100; ¶0118).
Regarding claim 29, Cline in view of McMichael suggests the device of claim 1, and Cline further discloses that the conduit’s outer surface comprises sections designed to apply lower radial force on the intestine internal wall constantly or alternately (Figs. 10A-C, feats. 56, 64, 68; ¶0101-0104).
Regarding claim 35, Cline discloses the conduit of claim 33, but does not disclose that the sleeve’s length is longer than a user’s abdominal wall’s thickness, wherein the length of said ostomy draining conduit is optionally adjustable.
As discussed above, McMichael teaches a stoma device (Figs. 1-5, feat. 10; ¶0028) comprising a first internal bolster (14; ¶0028 and 0030), a second external bolster (30; ¶0031), and a tube (12; ¶0028), which respectively correspond to the proximal internal sealing edge, the flange or mating ring connecting the distal external draining edge to the body fitment, and conduit/hollow sleeve of the device disclosed by Cline. The second external bolster (Figs. 1 and 4-5, feat. 30) engages protruding grooves or threads on the outer surface (22) of the tube (12) with a membrane or spring clip (41), which permits easy one-way advancement of the second external bolster towards the first internal bolster to sandwich the abdominal wall between the two bolsters (¶0031). Because the bolsters sandwich the abdominal wall to secure the tube in place in the wall, McMichael teaches that the tube is longer than the thickness of the abdominal wall. McMichael further teaches that the length of the tube may be shortened, and therefore adjusted, as necessary by the clinician (¶0032). McMichael teaches that this advantageously allows the tube to be secured in place with a snug but not too tight fit, while also allowing the external bolster to be further advanced if necessary, such as if swelling around the stoma site decreases (¶0031 and 0039). Modifying the device of Cline so that the conduit/hollow sleeve of Cline has grooves or threads on the outer surface like the tube of McMichael and so that the flange or mating ring of Cline has a membrane or spring clip for attaching to the tube like the one taught by McMichael would advantageously allow the fit of the device to be easily tightened if necessary as taught by McMichael. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the conduit disclosed by Cline so that the sleeve’s length is longer than a user’s abdominal wall’s thickness and so that the length of said ostomy draining conduit is optionally adjustable in order to allow the flange or mating ring for attaching to the body fitment to be adjustably secured to the tube and allow the fit of the device to be easily tightened if necessary as taught by McMichael.
Regarding claim 36, Cline in view of McMichael suggests the conduit of claim 35. As discussed above, Michael teaches a membrane or spring clip (Figs. 1 and 4-5, feat. 41) which mounts the second external bolster (30) onto protruding grooves or threads on the outer surface (22) of the tube (12) in order to permit easy one-way advancement of the second external bolster towards the first internal bolster to sandwich the abdominal wall between the two bolsters, thereby securing the tube in place (¶0031 and 0039). Because the tube is secured to the abdominal wall between the first internal bolster and the second external bolster, and the membrane or spring clip secures the second external bolster to the protruding grooves on the tube (¶0031 and 0039), the protruding grooves in part anchor the conduit to the internal and external portions of the abdominal wall. Therefore, Cline in view of McMichael further suggests an external membrane mounted onto said connecting sleeve, wherein movement of said external membrane along the sleeve towards the internal sealing edge creates a sealing axial force to affix said conduit in place, and wherein said external membrane is anchored along the sleeve by dedicated protrusions and rims, wherein the protrusions anchor the ostomy draining conduit to the abdomen’s inner walls.
Regarding claim 37, Cline in view of McMichael suggests the conduit of claim 35, and Cline further discloses that said sleeve comprises a region that is self-collapsible, thereby preventing unintentional damage to the stoma’s walls during insertion of the conduit into the stoma (¶0092-0094).
Regarding claim 43, Cline in view of McMichael suggests the device of claim 1, and Cline further discloses a self-expandable support stent located within the hollow sleeve, the support stent configured to apply radial force/pressure between the external walls of the hollow sleeve against the inner walls of the stoma (Figs. 15A-C, feat. 80; ¶0112-0113).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Cline in view of McMichael and in further view of Kay (US 4,596,566 A).
Regarding claim 6, Cline in view of McMichael suggest the device of claim 1. Cline further discloses that there is a margin of peristomal skin (Figs. 1-3B, feat. 12) between the edge of the stoma (10) and the inner edge of the adhesive wafer of the stoma-bag adapter flange (32; ¶0079 and 0087). Therefore, Cline further discloses that the stoma-bag adapter flange is configured to surround the stoma’s external wall without direct contact therewith.
As discussed above, Michael teaches a membrane or spring clip (Figs. 1 and 4-5, feat. 41) which mounts the second external bolster (30) onto protruding grooves or threads on the outer surface (22) of the tube (12) in order to permit easy one-way advancement of the second external bolster towards the first internal bolster to sandwich the abdominal wall between the two bolsters, thereby securing the tube in place (¶0031 and 0039). Because the tube is secured to the abdominal wall between the first internal bolster and the second external bolster, and the membrane or spring clip secures the second external bolster to the protruding grooves on the tube (¶0031 and 0039), the protruding grooves in part anchor the conduit to the internal and external portions of the abdominal wall. Therefore, Cline in view of McMichael further suggests that said external membrane is anchored along the sleeve by dedicated protrusions rim, wherein the protrusions anchor the ostomy draining device to the abdomen’s inner walls.
Cline in view of McMichael do not suggest that said baseplate is adhesive-free or non-adhesive.
Kay teaches a baseplate (Figs. 1 and 13-15, feat. 22; Col. 7, lines 5-64) for securing a collection bag (24) to a stoma. The baseplate comprises vacuum chambers (Figs. 13-15, feats. 80 and 82) which may be evacuated in order to secure the baseplate to the wearer’s skin using vacuum pressure (Col. 7, lines 5-44), which advantageously avoids the use of adhesives which may irritate or damage the wearer’s skin (Col. 6, lines 4-16). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Cline in view of McMichael so that the baseplate is secured to the wearer’s skin using vacuum pressure and is therefore adhesive free or non-adhesive in order to avoid the use of adhesives which may irritate or damage the wearer’s skin as taught by Kay.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Cline in view of McMichael, in further view of Kay, and in further view of Andersen (US 2004/0039357 A1).
Regarding claim 9, Cline in view of McMichael and in further view of Kay suggests the device of claim 6, but does not disclose a flexible sealing sleeve adaptor integrated with said baseplate, such that said external draining edge of said conduit enables sealed (leakage-free) fluid connection between said conduit and a stoma bag that is connected to said stoma-bag adapter flange.
Andersen teaches a soft and flexible stoma cuff (Figs. 1 and 6, feat. 1; ¶0018-0020) which forms a leakproof seal between the colon (10) and a baseplate (15). The stoma cuff may be integrated into the baseplate (Fig. 6; ¶0024). Andersen teaches that such a flexible sealing cuff advantageously protect the skin from the material coming out of the stoma (¶0007). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Cline in view of McMichael and in further view of Kay so that it comprises a flexible sealing sleeve adaptor integrated with said baseplate, such that said external draining edge of said conduit enables sealed (leakage-free) fluid connection between said conduit and a stoma bag that is connected to said stoma-bag adapter flange in order to protect the skin from the material coming out of the stoma as taught by Andersen.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Cline in view of McMichael, in further view of Burton (US 4,721,508 A), and in further view of Schertiger et al. (US 2013/0072886 A).
Regarding claim 11, Cline in view of McMichael suggests the device of claim 1, and Cline further discloses that the external draining edge (Figs. 4A-C, feat. 24) of said conduit (20) comprises a detachable connection flange (46; ¶0088-0090). Cline in view of McMichael does not suggest a capping plug, wherein a flexible sealing sleeve is: attached to said detachable connection flange by a clamp or an elastic ring and made of a hydrophobic membrane filter permeable to intestine gas and impermeable to intestine liquid.
Burton teaches an ostomy device (Fig. 1, feat. 10; Col. 2, line 24 – Col. 3, line 26) comprising a baseplate (Fig. 1, feat. 14; Col. 3, lines 4-26) with a stoma-bag adapter flange (14.3) for sealingly mounting a flexible stoma-bag or sleeve (16) via an elastic ring (16.1; Col. 3, lines 20-26). Burton further teaches a capping plug (Fig. 1, feat. 18) for closing the ostomy device (Col. 3, lines 27-44). Burton teaches that such features advantageously allow for the flow of bowel contents into the bag to be regulated by the patient (Col. 1, lines 38-68). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Cline in view of McMichael so that the device is equipped with a capping plug, wherein a flexible sealing sleeve is: attached to said detachable connection flange by a clamp or an elastic ring in order to allow for the flow of bowel contents to be regulated by the patient as taught by Burton.
Cline in view of McMichael and in further view of Burton does not suggest that the sleeve is made of a hydrophobic membrane filter permeable to intestine gas and impermeable to intestine liquid.
Schertiger teaches an ostomy appliance (Fig. 1, feat. 1; ¶0156) comprising a gas permeable, moisture impermeable hydrophobic membrane (20; ¶0063 and 0156) at the gas-outlet (22) of the appliance. Schertiger teaches that such a membrane aids with preventing ballooning by allowing gas to vent out of the appliance (¶0002-0005, 0063, and 0156). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Cline in view of McMichael and in further view of Burton so that the sleeve is made of a hydrophobic membrane filter permeable to intestine gas and impermeable to intestine liquid in order to prevent ballooning by allowing gas to vent as taught by Schertiger.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Cline in view of McMichael and in further view of Eskaros et al. (US 2018/0221194 A1).
Regarding claim 18, Cline in view of McMichael suggests the device of claim 1, but does not suggest that said conduit further comprises one or more reinforcement rigid rings designed to prevent axial collapsing and flipping of the expanding internal sealing edge during insertion thereof into the stoma.
Eskaros teaches a stoma device (Fig. 4; ¶0007-0010 and 0028-0035) comprising a conduit (Fig. 4, feats. 20 and 23) with a support structure (19) comprising a series of rings which prevents the collapse, twisting, and kinking of the conduit (¶0032). Eskaros teaches that this advantageously prevents narrowing and the resulting slowdown of flow (¶0032). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Cline in view of McMichael so that said conduit further comprises one or more reinforcement rigid rings designed to prevent axial collapsing and flipping of the expanding internal sealing edge during insertion thereof into the stoma in order to prevent narrowing and the resulting slowdown of flow through the conduit as taught by Eskaros.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Cline in view of McMichael and in further view of Millis et al. (US 2019/0021762 A1).
Regarding claim 24, Cline in view of McMichael suggests the device of claim 23, but does not disclose that said detachable applicator is self-collapsible when an axial force higher than 5-10N is applied, thereby preventing unintentional erosion or perforation of the intestine during insertion of the conduit into the stoma.
Millis teaches an ostomy device (Figs. 2A-2B, feat. 200; ¶0341-0347) comprising a conduit (214), an internal bolster (208), and an external bolster (210). Millis teaches that making portions of the ostomy device elastically deflectable under forces less than 1-10 N can advantageously prevent pain, damage, and discomfort to the patient’s tissues (¶0280-0287). The claimed range of forces of 5-10N lies within the prior art range of less than 1-10N, and therefore the claimed range is prima facie obvious. Please see MPEP §2144.05(I). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Cline in view of McMichael so that said detachable applicator is self-collapsible when an axial force higher than 5-10N is applied, thereby preventing unintentional erosion or perforation of the intestine during insertion of the conduit into the stoma in order to prevent pain, damage, and discomfort to the patient’s tissues when the applicator is in the patient’s body as taught by Millis.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Cline in view of McMichael, in further view of Schena et al. (US 2006/0111682 A1), and in further view of Masters (WO 2004/0004613 A1).
Regarding claim 31, Cline in view of McMichael suggests the device of claim 1, but does not disclose a stoma-bag flange connector equipped with a stoma-bag washer comprising: a circular pierced sprinkler tube attached to the stoma-bag flange connector’s inner circumference; b. a flexible washing tube connected to said sprinkler tube; and c. a flexible rubber nozzle welded to the other edge of the flexible washing tube and designed to associate with a faucet mouthpiece.
Schena teaches an ostomy bag cleaning system (Figs. 1-3; ¶0021-0026) comprising a circular pierced sprinkler tube (Fig. 3, feat. 20a) which may be on the inner circumference of a stoma-bag flange connector (Figs. 1 and 3, feat. 14a; ¶0021-0026) for attaching a stoma-bag (10). The sprinkler tube is attached to an access fitting (Fig. 3, feat. 24a; ¶0026) which allows fluid communication with a flexible hose (Figs. 2-3, feat. 42; ¶0024-0026) with a water source. Schena teaches that this advantageously allows the stoma-bag to be quickly and effectively cleaned while still attached to the patient (¶0006-0008). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Cline in view of McMichael so that it includes a stoma-bag flange connector equipped with a stoma-bag washer comprising: a. a circular pierced sprinkler tube attached to the stoma-bag flange connector’s inner circumference; b. a flexible washing tube connected to said sprinkler tube in order to allow the stoma-bag to be quickly and effectively cleaned while still attached to the patient as taught by Schena.
Schena teaches that the flexible hose (Fig. 2, feat. 42) attaches to the water supply tubing of a toilet, and not a faucet as claimed.
Masters teaches a kit for cleaning a stoma-bag (Fig. 1, feat. 4; page 3, lines 18-20) comprising a manifold (20) attached to a flexible tube (2) with a rubber sleeve (22) for sealingly engaging about the outlet of any standard bathroom faucet (Page 4, lines 4-10). Masters teaches that this allows for simple and effective cleaning of the stoma-bag (Col. 5, lines 1-3). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Cline in view of McMichael and in further view of Schena so that the stoma-bag washer comprises c. a flexible rubber nozzle welded to the other edge of the flexible washing tube and designed to associate with a faucet mouthpiece in order to allow for simple and effective cleaning of the stoma bag as taught by Masters.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Cline in view of McMichael and in further view of Edvardsen et al. (US 2012/0143155 A1).
Regarding claim 32, Cline in view of McMichael suggests the device of claim 1, but does not disclose that the outer surface of the conduit’s external draining edge is coated with a pH or other conductivity color-changing element for indicating any intestinal liquid leak.
Edvardsen teaches an ostomy device (Figs. 1-2; ¶0044) comprising a color-changing leakage indicator which may be a pH indicator (7; ¶0022, 0029-0033, and 0044). The detection portion of the leakage indicator may be located close to the stoma (3; ¶0044). Edvardsen teaches that such a leakage indicator advantageously allows for early and selective indication of a leak, which enables changing components before the leak progresses too far (¶0018-0021 and 0029-0031). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Cline in view of McMichael so that the outer surface of the conduit’s external draining edge is coated with a pH or other conductivity color-changing element for indicating any intestinal liquid leak in order to allow for early and selective indication of a leak, enabling a user to change the components of the device before the leak progresses too far as taught by Edvardsen.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 5712727159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
