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 .
Response to Amendment
Applicant amended claims 1, 3, 6, 9, 11, 16, 18, 22-24, 31-33, 35-37, and 39. Claims 1, 3, 6, 9, 11, 16, 18, 22-24, 29, 31-33, 35-37, and 39 are currently pending.
Response to Arguments
Applicant’s arguments, see page 7 of Applicant’s Remarks, filed 08/11/25, with respect to the rejections of the claims under 35 U.S.C. 112(b) have been fully considered and are persuasive in light of the amendments. Therefore, the rejections have been withdrawn.
Applicant’s arguments, see pages 8-10 of Applicant’s Remarks, 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 being unpatentable over Eskaros have been fully considered and are not persuasive.
Applicant argues, see page 8, that the claimed device expands to a diameter that is smaller than the diameter of the intestine. As discussed below, Eskaros discloses that the proximal portion expands to contact the intestine’s inner wall, and therefore has a smaller diameter than the intestine as claimed.
Applicant further argues, see page 8, that the proximal self-expanding internal sealing edge of the conduit disclosed by Eskaros is not self-collapsible. However, because the support (Fig. 4, feat. 19; ¶0029-0031) is self-expanding, it returns to its original shape after deformations like being collapsed or expanded, which means that it is also self-collapsing.
Applicant further argues, see pages 8-10, that the device disclosed by Eskaros fully diverts the intestinal contents and does not allow the passage of liquid and stool within the intestine as claimed. However, the claims only require that the device allow the passage of liquid and stool, and do not require that the passage of liquid and stool be within the intestine.
Applicant further argues, see page 10, that Eskaros aims to address the problem of creating a stoma while the claimed device is designed to work together with a stoma. However, as discussed below, the device disclosed by Eskaros has the claimed structure, and therefore anticipates the claimed device.
Applicant’s arguments, see pages 11-12, with respect to the rejections of claims 6 and 36 under 35 U.S.C. 103 as being unpatentable over Eskaros in view of Burton and in further view of Millis have been fully considered and are not persuasive.
Applicant argues, see pages 11-12, that the teachings of Burton are irrelevant to the claimed invention. However, because Burton teaches an ostomy prosthesis, it is from the same field of endeavor as the claimed invention, and therefore Burton is analogous prior art. Please see MPEP §2141.01(a)(I).
Applicant further argues, see page 12, that the protrusions taught by Burton are irrelevant to the claimed device because the protrusions of Burton are used to affix a tube to a baseplate while the claimed protrusions are used to achieve fixation of the device to the abdomen inner wall. However, claim 6 only requires that the protrusions anchor the external membrane along the sleeve of the conduit, and makes no mention of the protrusions being used to adhere the device to the abdomen inner walls. As discussed below, Burton renders it obvious for protrusions to anchor the external membrane along the sleeve of the conduit as claimed.
Applicant further argues that Eskaros and Burton are silent about the possibility that the sleeve’s length is longer than the abdominal wall’s thickness as claimed. With respect to claim 6, the sleeve being longer than the abdominal wall’s thickness is part of the subject matter of claim 3, and is therefore not part of the scope of claim 3. With respect to claim 36, the sleeve being longer than the abdominal wall’s thickness is part of the subject matter of claim 35, with is anticipated by Eskaros as indicated below.
Applicant’s arguments, see page 12, with respect to the rejection of claim 9 under 35 U.S.C. 103 as being unpatentable over Eskaros in view of Burton, in further view of Millis, and in further view of Andersen have been fully considered and are not persuasive because the combination of Eskaros, Burton, and Millis suggests the invention of claim 6 as indicated below.
Applicant’s arguments, see page 13, with respect to the rejection of claim 11 under 35 U.S.C. 103 as being unpatentable over Eskaros in view of Tsai have been fully considered and are persuasive in light of the amendment to claim 11 rendering the capping plug and flexible sealing sleeve non-optional. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection have been made as indicated below.
Applicant’s arguments, see page 13, with respect to the rejection of claim 23 under 35 U.S.C. 103 as being unpatentable over Eskaros in view of Hanuka and the rejection of claim 24 in further view of Miller have been fully considered and are not persuasive. Applicant argues that one of ordinary skill in the art would have had no incentive to reach the claimed conduit. However, as discussed below, Eskaros discloses the structure of the claimed conduit, and Hanuka teaches that employing an applicator for inserting such a conduit improves the ease of insertion.
Applicant’s arguments, see page 13, with respect to the rejection of claim 31 under 35 U.S.C. 103 as being unpatentable over Eskaros in view of Schena and in further view of Masters have been fully considered and are not persuasive because Eskaros discloses the device of claim 1, and therefore combination with Schena and Masters renders obvious the device of claim 31.
Applicant’s arguments, see page 14, with respect to the rejection of claim 32 under 35 U.S.C. 103 as being unpatentable over Eskaros in view of Edvardsen have been fully considered and are not persuasive because Eskaros discloses the device of claim 1, and therefore combination with Edvardsen renders obvious the device of claim 32.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 22-24 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 22 is dependent on canceled claim 21, claim 23 is dependent on canceled claim 20, and claim 24 is dependent on claim 23. Therefore, claims 22-24 are in improper dependent form. For the purpose of examination, claims 22 and 23 were considered to be dependent upon claim 1, as they were indicated to be in the previous claim set. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 3, 16, 18, 22, 29, 33, 35, 37, and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eskaros et al. (US 2018/0221194 A1).
Regarding claim 1, Eskaros discloses an ostomy draining device (Fig. 4; ¶0007-0010 and 0028-0035) comprising an ostomy draining/disposing conduit (Fig. 4, feats. 20 and 23), said conduit comprising a proximal self-expanding internal sealing edge designed to be inserted into a stoma and sealing passage between the conduit’s exterior wall and the stoma’s inner wall (Fig. 4, feats. 19 and 20; ¶0028-0031: proximal portion 20 includes self-expanding support 19 which expands to engage the intestine 11 and is made from a barrier material that prevents leaks, and therefore seals against the stoma); and a distal external draining edge (Fig. 4, feat. 23; ¶0033 and 0036), characterized in that when inserted into the stoma it allows passage of liquid and stool while preventing passage between the conduit’s exterior wall and the stoma’s interior wall (¶0028-0035: distal portion 23 includes self-expanding support 19 and may be made from the same barrier material as the proximal portion, and would therefore also seal against the stoma and prevent leaks), wherein (i) the proximal self-expanding internal sealing edge’s diameter is smaller than an intestine’s diameter (Fig. 4, feat. 20; ¶0031: proximal portion 20 expands to engage the inner wall of the intestine 11, and therefore has a smaller diameter); 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 (Fig. 4, feat. 19; ¶0029-0031:Because support 19 is self-expanding, it returns to its original shape after deformations like being collapsed or expanded, which means that it is also self-collapsing.).
Regarding claim 3, Eskaros discloses the device of claim 1, and further discloses that said conduit further comprises a hollow sleeve connecting said proximal self-expanding internal sealing edge and said distal external draining edge (Fig. 4, feats. 20, 23, and 25; ¶0038: proximal portion 20 and distal portion 23 are connected by transitional portion 25 (mislabeled as 15 in the figure) to form a continuous sleeve) characterized in that a length of the hollow sleeve is longer than an abdominal wall’s thickness (Fig. 4; ¶0035-0036), wherein 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 (¶0029-0035, especially 0031: proximal 20 and distal portions 23 both include self-expanding support 19 which can also be compressible from an expanded state), and wherein the length of the ostomy draining conduit is optionally adjustable (¶0036).
Regarding claim 16, Eskaros discloses the device of claim 1, and further discloses that said conduit further comprises a self-expandable support stent located therein (Fig. 4, feat. 19; ¶0029-0030).
Regarding claim 18, Eskaros discloses the device of claim 1, and further discloses that said conduit further comprises one or more reinforcement rigid rings designed to prevent axial collapsing and flipping of the expanding sealing edge during insertion thereof into the stoma (Fig. 4, feat. 19; ¶0029-0035: support structure 19 may be a series of rings and prevents the collapse, twisting, and kinking of the proximal 20 and distal 23 portions).
Regarding claim 22, Eskaros discloses the device of claim 1, and further discloses that said conduit comprises a flexible polymeric sleeve made of a degradable polymer (¶0028: the proximal portion 20 may include a bioabsorbable, and therefore degradable, polymer).
Regarding claim 29, Eskaros discloses the device of claim 1, and further discloses that the conduit’s outer surface comprises sections designed to apply a lower radial force on the intestine internal wall constantly or alternately (Fig. 4, feat. 19; ¶0029-0035: support structure 19 comprises spaced apart rings attached to the proximal 20 and distal portions 23, and therefore the proximal portion of the conduit would provide higher radial forces against the intestine 11 where the rings are present and lower radial forces where they are absent).
Regarding claim 33, Eskaros discloses an ostomy draining/disposing conduit (Fig. 4, feats. 20 and 23; ¶0007-0010 and 0028-0035) comprising a proximal self-expanding internal sealing edge designed to be inserted into a stoma and sealing passage between the conduit’s exterior wall and the stoma’s inner wall (Fig. 4, feats. 19 and 20; ¶0028-0031: proximal portion 20 includes self-expanding support 19 which expands to engage the intestine 11 and is made from a barrier material that prevents leaks, and therefore seals against the stoma); and a distal external draining edge (Fig. 4, feat. 23; ¶0033 and 0036), characterized in that when inserted into the stoma it 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) (¶0028-0035: distal portion 23 includes self-expanding support 19 and may be made from the same barrier material as the proximal portion, and would therefore also seal against the stoma and prevent leaks), wherein: (i) the proximal self-expanding internal sealing edge’s diameter is smaller than an intestine’s diameter (Fig. 4, feat. 20; ¶0031: proximal portion 20 expands to engage the inner wall of the intestine 11, and therefore has a smaller diameter) ); 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 (Fig. 10, feats. 101 and 102; ¶0029, 0031, and 0045: Self-expanding support 19 of the proximal portion 20 may be collapsed or compressed by a tensioning member 102 integral with a radial component 101 of the proximal portion, and is therefore self-collapsible. Because the support 19 is self-expanding, it expands to its original shape once inserted).
Regarding claim 35, Eskaros discloses the conduit of claim 33, and further discloses a hollow sleeve connecting said proximal self-expanding internal sealing edge and said distal external draining edge (Fig. 4, feats. 20, 23, and 25; ¶0038: proximal portion 20 and distal portion 23 are connected by transitional portion 25 (mislabeled as 15 in the figure) to form a continuous sleeve) characterized in that a length of the hollow sleeve is longer than an abdominal wall’s thickness (Fig. 4; ¶0035-0036), and wherein the length of the ostomy draining conduit is optionally adjustable (¶0036).
Regarding claim 37, Eskaros discloses the conduit of claim 35, and 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 (¶0029-0035, especially 0031: proximal 20 and distal portions 23 both include self-expanding support 19 which can also be compressed from an expanded state).
Regarding claim 39, Eskaros discloses the conduit of claim 33, and further discloses that said proximal self-expanding internal sealing edge is self-collapsible, characterized in that it can be modified/re-shaped for insertion thereof into the stoma, and return to its original shape once inserted into the stoma Fig. 10, feats. 101 and 102; ¶0029-0035 and 0045: Self-expanding support 19 of the proximal portion 20 may be collapsed or compressed by a tensioning member 102 integral with a radial component 101 of the proximal portion, and is therefore self-collapsible. Because the support 19 is self-expanding, it expands to its original shape once inserted).
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 6 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Eskaros et al. (US 2018/0221194 A1) in view of Burton (US 4,721,508 A) and in further view of Millis et al. (US 2019/0021762 A1).
Regarding claim 6, Eskaros discloses the ostomy draining device of claim 1, and further discloses a body attachment baseplate for attaching said ostomy device to an ostomate, said baseplate comprising a stoma-bag adapter flange (Fig. 4, feat. 18; ¶0038) but does not disclose that the flange does not have an external stoma wall sealant and is designed to surround the stoma’s external wall without direct contact therewith, that the baseplate is adhesive-free or non-adhesive, or that said baseplate optionally: (i) comprises a gas filter with an odor absorbance layer or (ii) is flippable to enable monitoring and management of peristomal skin under the baseplate. Eskaros is further silent with respect to an elastic sealing external membrane mounted onto said connecting 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, wherein said external membrane is anchored along the sleeve by dedicated protrusion rims.
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 for sealingly mounting a stoma-bag (14.3) and which is mounted on an ostomy drainage tube (12) via circumferential sawtooth protrusions (12.5). As the baseplate (14) is moved axially along the tube (12), an orifice in the baseplate (14.1) is captured by the dedicated sawtooth protrusions (12.5), which affixes the tube in place without adhesive (Col. 3, lines 4-26). The baseplate may have gauze between it and the skin (E; Col. 2, lines 31-39) and outer wall of the stoma (B), thereby not making direct contact and only indirectly bearing on it (Col. 3, lines 4-19). Burton teaches that such an adhesive-free attachment system between the tube, baseplate, and ostomy bag advantageously secures the tube while avoiding the need for adhesive, which may cause the skin surrounding the stoma to become irritated (Col. 1, lines 11-68). 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 disclosed by Eskaros so that it comprises a sealing external membrane mounted onto said connecting 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, wherein said external membrane is anchored along the sleeve by dedicated protrusions rims in order to secured the conduit while avoiding the need for adhesives which could irritate the skin and stoma as taught by Burton.
Eskaros in view of Burton do not disclose or teach that the external membrane is elastic.
Millis teaches an ostomy device (Figs. 2A-2B, feat. 200; ¶0341-0347) a conduit (214), an internal bolster (208), and an external bolster (210). Millis teaches that making the internal and/or external bolster elastically deflectable can advantageously prevent pain, damage, and discomfort to the patient’s tissues (¶0280-0281). 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 Eskaros in view of Burton so that the external membrane is elastic in order to prevent pain, damage, and discomfort to the patient’s tissues as taught by Millis.
Regarding claim 35, Eskaros discloses the conduit of claim 33. Eskaros is silent with respect to an elastic sealing external membrane mounted onto said connecting 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, wherein said external membrane is anchored along the sleeve by dedicated protrusion and rims.
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 for sealingly mounting a stoma-bag (14.3) and which is mounted on an ostomy drainage tube (12) via circumferential sawtooth protrusions (12.5). As the baseplate (14) is moved axially along the tube (12), an orifice in the baseplate (14.1) is captured by the dedicated sawtooth protrusions (12.5), which affixes the tube in place without adhesive (Col. 3, lines 4-26). The baseplate may have gauze between it and the skin (E; Col. 2, lines 31-39) and outer wall of the stoma (B), thereby not making direct contact and only indirectly bearing on it (Col. 3, lines 4-19). Burton teaches that such an adhesive-free attachment system between the tube, baseplate, and ostomy bag advantageously secures the tube while avoiding the need for adhesive, which may cause the skin surrounding the stoma to become irritated (Col. 1, lines 11-68). Because the baseplate of Burton includes both a stoma-bag adapter flange and affixes the tube in place when it is captured by the dedicated sawtooth protrusions, it acts as both the claimed body attachment baseplate and sealing external membrane. 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 Eskaros so that said baseplate comprises a stoma-bag adapter flange without an external stoma wall sealant, designed to surround the stoma’s external wall without direct contact therewith, characterized in that said baseplate is adhesive-free or non-adhesive, wherein said baseplate optionally: (i) comprises a gas filter with an odor absorbance layer, or (ii) is flippable to enable monitoring and management of peristomal skin under the baseplate; and a sealing external membrane mounted onto said connecting 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, wherein said external membrane is anchored along the sleeve by dedicated protrusions rims in order to secured the conduit while avoiding the need for adhesives which could irritate the skin and stoma as taught by Burton.
Eskaros in view of Burton do not disclose or teach that the external membrane is elastic.
Millis teaches an ostomy device (Figs. 2A-2B, feat. 200; ¶0341-0347) a conduit (214), an internal bolster (208), and an external bolster (210). Millis teaches that making the internal and/or external bolster elastically deflectable can advantageously prevent pain, damage, and discomfort to the patient’s tissues (¶0280-0281). 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 Eskaros in view of Burton so that the external membrane is elastic in order to prevent pain, damage, and discomfort to the patient’s tissues as taught by Millis.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Eskaros et al. (US 2018/0221194 A1) in view of Burton (US 4,721,508 A), in further view of Millis et al. (US 2019/0021762 A1), and in further view of Andersen (US 2004/0039357 A1).
Regarding claim 9, Eskaros in view of Burton and in further view of Millis discloses the device of claim 6, but does not disclose a flexible sealing sleeve adaptor integrated with the said baseplate as claimed.
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 stoma cuff advantageously protects 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 disclosed by Eskaros in view of Burton and in further view of Millis so that it further comprises a flexible sealing sleeve adapter 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 Eskaros et al. (US 2018/0221194 A1) in view of Tsai et al. (US 2008/0103463 A1) in view of Burton (US 4,721,508 A) and in further view of Schertiger et al. (US 2013/0072886 A).
Regarding claim 11, Eskaros discloses the device of claim 1, but does not disclose that the external draining edge of said conduit comprises a detachable connection flange, and 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; and made of a hydrophobic membrane filter permeable to intestine gas and impermeable to intestine liquid.
Tsai teaches an ostomy device (Figs. 1-2, feat. 10; ¶0036 and 0051) comprising a tube (12) with a support connector (16) at its external edge. The support connector may comprise a landing zone or flange (20a) for coupling to a fecal collection container (¶0036) and is coupled to the tube via locating flanges (30) which interlock against the support connector (¶0051). Because the support connector is attached to the tube via the locating flanges, it may be removed from the tube via the locating flanges. 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 Eskaros so that the external draining edge of said conduit comprises a detachable connection flange in order to couple the device to a fecal collection container as taught by Tsai.
Eskaros in view of Tsai does not disclose 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; 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 disclosed by Eskaros in view of Tsai 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.
Eskaros in view of Tsai and in further view of Burton does not disclose 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 disclosed by Eskaros in view of Tsai 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 23 is rejected under 35 U.S.C. 103 as being unpatentable over Eskaros et al. (US 2018/0221194 A1) in view of Hanuka et al. (US 8,998,862 B2).
Regarding claim 23, Eskaros discloses the device of claim 1, but does not disclose a detachable applicator for inserting the conduit into the stoma.
Hanuka teaches an ostomy device (Fig. 1, feat. 100; Col. 18, line 30 – Col. 19, line 23) comprising a conduit for conducting waste out of the body (Fig. 1, feat. 2; Col. 18, line 43 – Col. 19, line 23) and an applicator or introducer (Figs. 29D-29G, feat. 2900; Col. 36, line 48 – Col. 37, line 46) for inserting the conduit (Figs. 29D-29G, feat. 2902C) into a stomal opening. The applicator comprises a flexible envelope (Fig. 29D, feat. 2920) which attaches to and covers the distal end of the conduit (Figs. 29E-29F, feat. 2912C; Steps 1-5; Col. 37, lines 5-25), at which point the applicator and conduit are inserted into the stomal opening and the flexible envelope is detached from the conduit, leaving the conduit in place (Figs. 29F-29G; Steps 6-8; Col. 37, lines 26-42). Hanuka teaches that such an applicator allows for easy insertion of the conduit (Col. 37, lines 21-25). 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 Eskaros so that it further comprises a detachable applicator for inserting the conduit into the stoma in order to allow for easy insertion of the conduit as taught by Hanuka.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Eskaros et al. (US 2018/0221194 A1) in view of Hanuka et al. (US 8,998,862 B2) and in further view of Millis et al. (US 2019/0021762 A1).
Regarding claim 24, Eskaros in view of Hanuka discloses the device of claim 23. As discussed above, Hanuka teaches that the applicator comprises a flexible envelope (Fig. 29D, feat. 2920; Col. 36, line 56 – Col. 37, line 4), and therefore that the applicator is self-collapsible. Hanuka does not teach the force at which the applicator collapses.
As discussed above, Millis teaches an ostomy device (Figs. 2A-2B, feat. 200; ¶0341-0347) 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 1-10N can advantageously prevent pain, damage, and discomfort to the patient’s tissues (¶0280-0287). Because the portions of the ostomy device of Millis deflect under forces less than 1-10N, they would also deflect under forces greater than that range. 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 disclosed by Eskaros in view of Hanuka 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 as taught by Millis.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Eskaros et al. (US 2018/0221194 A1) in view of Schena et al. (US 2006/0111682 A1) and in further view of Masters (WO 2004/004613 A1).
Regarding claim 31, Eskaros discloses the device of claim 1, but does not disclose 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; 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 disclosed by Eskaros 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 disclosed by Eskaros in 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 Eskaros et al. (US 2018/0221194 A1) in view of Edvardsen et al. (US 2012/0143155 A1).
Regarding claim 32, Eskaros discloses 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 disclosed by Eskaros 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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