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, 12, and 22. Claims 1, 4-13, 16-18, 21-22, and 24-31 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 7-9 of Applicant’s Remarks, filed 10/13/25, with respect to the rejections of claims 1, 4-13, 16-18, and 21 under 35 U.S.C. 103 as being unpatentable over Sanchez in view of Welch and in further view of Kay have been fully considered and are persuasive in light of the amendments to the claims. Therefore, the rejections have been withdrawn. However, upon further search and consideration, new grounds of rejection have been made as indicated below.
Applicant’s arguments, see pages 9-10 of Applicant’s Remarks, filed 10/13/25, with respect to the rejections of claims 22 and 24-28 under 35 U.S.C. 103 as being unpatentable over Sanchez in view of Kay have been fully considered and are not persuasive. Applicant argues that the PTO has not demonstrated that the combination of Sanchez and Kay teaches or suggests that the portion of the fluid impermeable barrier having the modulus of elasticity of about 4 N/in2 to about 20 N/in2 extends at least partially about the fluid permeable body and is at least partially positioned substantially opposite the portion of the fluid permeable body that extends across at least the portion of the opening. However, as discussed below, Kay teaches that the fluid collection channel (Figs. 1-2 and 11, feat. 28) of the housing (22) comprises walls which are opposite to the elongate opening (26) which is adjacent to the urethra during use. In the collection device of Sanchez (and the claimed device), the opening is adjacent the urethra during use, and the fluid permeable body has a portion adjacent to the opening (and the urethra). Therefore, because Kay teaches a portion of the housing that is opposite an opening adjacent to the urethra, modifying the device of Sanchez to include the material properties taught by Kay would also cause the portion of the barrier which is opposite the opening to have those material properties, and by extension, the portion of the barrier which is opposite of the portion of the fluid permeable body that extends across a portion of the opening.
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, 4-13, 16-18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez et al. (US 2017/0266031 A1) in view of Davis et al. (US 2015/0374535 A1) and in further view of Kay et al. (US 2011/0028922 A1).
Regarding claim 1, Sanchez discloses a fluid collection device (Figs. 27-31; ¶0132-0133; Figs. 32-33, feat. 1602; ¶0138-0139), comprising a fluid impermeable barrier (1504; 1604) configured to temporarily store fluids therein (¶0138-0139: fluid impermeable casing 1604 defines a reservoir 1610 to which fluid flows to and is stored before being suctioned out by tube 1621), the fluid impermeable barrier having an inner surface (Annotated Fig. 28/32, feat. A) at least partially defining a chamber (1510; 1610), an outer surface (Annotated Fig. 28/32, feat. B), an opening extending longitudinally along the fluid impermeable barrier (1504A; 1604A) and configured to be positioned adjacent to a female urethra of a female user while the fluid impermeable barrier is external to a vagina of the female user (Fig. 33; ¶0139, lines 1-5), and an aperture (1520; 1620) configured to receive a conduit therethrough (1621); wherein at least a portion of the fluid impermeable barrier extends from the inner surface of the fluid impermeable barrier (Annotated Fig. 28/32, feat. A) that defines the chamber (1510; 1610) to the outer surface of the fluid impermeable barrier (Annotated Fig. 28/32, feat. B); and a fluid permeable body positioned at least partially within the chamber and having a portion extending across at least a portion of the opening (1530; ¶0134; 1630; ¶0138) and configured to wick fluid away from the opening when the portion of the fluid permeable body is positioned adjacent to the female urethra while the fluid impermeable barrier is external to the vagina (¶0073 and 0138, lines 8-16), wherein the fluid impermeable barrier extends at least partially around the fluid permeable body (1530; ¶0134; 1630; ¶0138) and is at least partially positioned substantially opposite to the portion of the fluid permeable body that extends across at least the portion of the opening (Fig. 28, feats. 1504 and 1504A; Fig. 32, feats. 1604, 1604A, and 1630: fluid impermeable barrier 1504, 1604 has a portion positioned opposite the opening 1504A, 1604A and therefore opposite the portion of the permeable body 1530, 1630 which
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[AltContent: textbox (Annotated Fig. 28/32: A is adapted from fig. 28 of Sanchez and B is adapted from fig. 32 of Sanchez. A is the inner surface of the fluid impermeable membrane, B is the outer surface of the fluid impermeable membrane, and C is the outer surface of the permeable body.)]extends across the opening).
Sanchez discloses that the impermeable barrier is flexible and compliant so that the device can conform to differently shaped and/or sized users (¶0132 and 0138), but does not disclose the claimed shore A durometer hardness range of the impermeable barrier, the claimed thickness range of the fluid impermeable barrier, or that the portion of the fluid impermeable barrier which extends at least partially about the fluid permeable body and is positioned substantially opposite to the portion of the fluid permeable body that extends across at least the portion of the opening has the claimed shore A durometer hardness range.
Davis teaches a supplemental spout (Figs. 6-8, feat. 140; ¶0040-0041) for a urine collection device (Fig. 2, feat. 110; ¶0030) which is made of a soft, pliable, and waterproof material which is advantageously durable enough to maintain its shape, but soft enough to prevent any injury to the user (¶0041). Davis teaches that such a material has a shore A durometer hardness from 1 to 20 (¶0041). This overlaps the claimed range of shore A durometer hardnesses of about 2 to about 14, and therefore, a prima facie case of obviousness exists for the claimed range. Please see MPEP §2144.05(I). Additionally, because the supplemental spout of Davis is designed for fluid collection from a patient while any preventing injury to the patient, it is at least from the same field of endeavor as the claimed invention, as described in at least paragraph 0005 of the present specification. Please see MPEP §2141.01(a). Furthermore, as discussed above, Sanchez discloses that the fluid impermeable barrier has a portion which extends about the fluid permeable body and is positioned opposite to the portion of the fluid permeable body that extends across the opening, and modifying the fluid impermeable barrier of Sanchez to have a shore A durometer hardness in the range discussed by Davis would enable the fluid impermeable barrier to be durable enough to maintain its shape, but soft enough to prevent any injury to the user. 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 Sanchez so that at least the portion of the fluid impermeable barrier having a shore A durometer hardness of about 2 to about 14 and so that the portion of the fluid impermeable barrier which extends at least partially about the fluid permeable body and is positioned substantially opposite to the portion of the fluid permeable body that extends across at least the portion of the opening has the shore A durometer hardness of about 2 to about 14 so that the fluid impermeable barrier is durable enough to maintain its shape, but soft enough to prevent any injury to the user as taught by Davis.
Sanchez in view of Davis is silent with respect to the thickness of the fluid impermeable barrier.
Kay teaches a female external incontinence device for collecting urine (Figs. 1-2, feat. 20; ¶0028) comprising an intravaginal component (38), an adhesive flange (24) for interfacing with the body, a housing (22) with a urine collection channel (28), and an outlet tube (46). The housing (22), urine collection channel (28), and outlet tube (46) remain outside the body during use (Fig. 11). Kay teaches that that housing (22) should be a thin, soft, pliable, membranous elastomeric material, such as polyurethane or polyisoprene, with a thickness between 0.002 in to 0.017 in (about 0.05 mm to about 0.43 mm) and a flexural modulus of elasticity of below 30,000 psi (about 207 MPa or about 134 kN/in2) (¶0036) in order to ensure that the housing is soft and pliable enough to conform to the body and be comfortable during use (¶0010 and 0028, lines 39-43). The prior art thickness range of between about 0.05 mm to about 0.43 mm overlaps the claimed thickness range of about 0.2 mm to about 3.2 mm, and therefore a prima facie case exists for the claimed range. Please see MPEP §2144.05. 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 Sanchez in view of Davis so that the fluid impermeable barrier has a thickness of about 0.2 mm to about 3.2 mm defined between the inner surface and the outer surface in order to ensure that the fluid impermeable barrier is soft and pliable enough to conform to the body and be comfortable during use as taught by Kay.
Regarding claims 4-5, Sanchez in view of Davis and in further view of Kay suggests the device of claim 1. As discussed above, Kay teaches a housing thickness between 0.002 in to 0.017 in (about 0.05 mm to about 0.43 mm) in order to ensure that the housing is soft and pliable enough to conform to the body and be comfortable during use (¶0010 and 0028, lines 39-43). The prior art thickness range of between about 0.05 mm to about 0.43 mm overlaps the claimed thickness ranges of less than about 1.6 mm, with respect to claim 4, and less than about 0.8 mm, with respect to claim 5, and therefore a prima facie case exists for the claimed ranges. Please see MPEP §2144.05. 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 Sanchez in view of Welch and in further view of Kay so that the fluid impermeable barrier has a thickness of less than about 1.6 mm, with respect to claim 4, or a thickness of less than about 0.8 mm, with respect to claim 5 in order to ensure that the housing is soft and pliable enough to conform to the body and be comfortable during use as taught by Kay.
Regarding claim 6, Sanchez in view of Davis and in further view of Kay suggests the device of claim 1. Kay further teaches that that housing (22) should be a thin, soft, pliable, membranous elastomeric material, such as polyurethane or polyisoprene, with a thickness between 0.002 in to 0.017 in (about 0.05 mm to about 0.43 mm) and a flexural modulus of elasticity of below 30,000 psi (about 207 MPa or about 134 kN/in2) (¶0036) in order to ensure that the housing is soft and pliable enough to conform to the body and be comfortable during use (¶0010 and 0028, lines 39-43). Therefore, Sanchez in view of Davis and in further view of Kay further suggests that the fluid impermeable membrane includes a polyurethane film.
Regarding claim 7, Sanchez in view of Davis and in further view of Kay suggests the device of claim 1, and Sanchez further discloses a conduit including an inlet and an outlet (Fig. 16, feat. 1621; ¶0138-0139: tube 1621 has its inlet near reservoir 1610 and outlet near aperture 1620), wherein at least a portion of the conduit (1621) extends through the aperture (1620) and into the chamber (1610), the fluid permeable body being configured to wick fluid away from the opening to the inlet (¶0073 and 0139: permeable membrane 1630 wicks fluid away from the user’s urethra and skin at opening 1604A such that it flows to the reservoir 1610 at the inlet of the conduit 1621).
Regarding claim 8, Sanchez in view of Davis and in further view of Kay suggests the device of claim 7, and Sanchez further discloses that the fluid permeable body (Fig. 32, feat. 1630) includes an outer surface and no more than two layers of material between the opening (1604A) and the conduit (1621; layers between opening 1604A and conduit 1621 are fluid permeable body 1630 and fluid permeable support 1640); and the fluid impermeable barrier includes an inner surface at least partially defining the chamber (Fig. 32; ¶0138: chamber 1610 is defined inside the fluid impermeable casing 1604), the inner surface interfacing with the outer surface of the fluid permeable body (Fig. 32: fluid permeable body 1630 is adjacent the inside of fluid impermeable casing 1604).
Regarding claim 9, Sanchez in view of Davis and in further view of Kay suggests the device of claim 1. As discussed above, Kay teaches that that housing (22) should be a thin, soft, pliable, membranous elastomeric material, such as polyurethane or polyisoprene, with a flexural modulus of elasticity of below 30,000 psi (about 207 MPa or about 134 kN/in2) (¶0036) in order to ensure that the housing is soft and pliable enough to conform to the body and be comfortable during use (¶0010 and 0028, lines 39-43). The claimed modulus of elasticity range of about 4 N/in2 to 20 N/in2 lies within the prior art range of 0 – 134 kN/in2 taught by Kay, and therefore a prima facie case exists for the claimed range. Please see MPEP §2144.05. 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 Sanchez in view of Davis in further view of Kay so that the fluid impermeable barrier includes a modulus of elasticity of about 4 N/in2 to about 20 N/in2 in order to ensure that the housing is soft and pliable enough to conform to the body and be comfortable during use as taught by Kay.
Regarding claim 10, Sanchez in view of Davis and in further view of Kay suggests the device of claim 1. Kay further teaches that the housing may be made of polyisoprene (¶0036), which is a thermoplastic elastomer. Therefore, Sanchez in view of Davis and in further view of Kay further suggests that the fluid impermeable barrier includes a thermoplastic elastomer.
Regarding claim 11, Sanchez in view of Davis and in further view of Kay suggests the device of claim 1. Sanchez further discloses that the fluid impermeable barrier includes a silicone material (¶0132). As discussed above, Davis teaches a supplemental spout (Figs. 6-8, feat. 140; ¶0040-0041) for a urine collection device (Fig. 2, feat. 110; ¶0030) which is made from a material having a shore A durometer hardness from 1 to 20 and is advantageously durable enough to maintain its shape, but soft enough to prevent any injury to the user (¶0041). The prior art range of 1 to 20 overlaps the claimed range of less than 5, and therefore, a prima facie case of obviousness exists for the claimed range. 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 Sanchez in view of Davis and in further view of Kay so that the fluid impermeable barrier has a shore A durometer of hardness of less than 5 so that the fluid impermeable barrier is durable enough to maintain its shape, but soft enough to prevent any injury to the user as taught by Davis.
Regarding claim 12, Sanchez discloses a fluid collection device (Figs. 27-31; ¶0132-0133; Figs. 32-33, feat. 1602; ¶0138-0139), comprising a fluid impermeable barrier (1504; 1604) configured to temporarily store fluids therein (¶0138-0139: fluid impermeable casing 1604 defines a reservoir 1610 to which fluid flows to and is stored before being suctioned out by tube 1621), the fluid impermeable barrier having an inner surface (Annotated Fig. 28/32, feat. A) at least partially defining a chamber (1510; 1610), an outer surface (Annotated Fig. 28/32, feat. B), an opening extending longitudinally along the fluid impermeable barrier (1504A; 1604A) and configured to be positioned adjacent to a female urethra of a female user while the fluid impermeable barrier is external to a vagina of the female user (Fig. 33; ¶0139, lines 1-5), and an aperture (1520; 1620) configured to receive a conduit therethrough (1621); wherein at least a portion of the fluid impermeable barrier extends from the inner surface of the fluid impermeable barrier (Annotated Fig. 28/32, feat. A) that defines the chamber (1510; 1610) to the outer surface of the fluid impermeable barrier (Annotated Fig. 28/32, feat. B); and a fluid permeable body positioned at least partially within the chamber and having a portion extending across at least a portion of the opening (1530; ¶0134; 1630; ¶0138) and configured to wick fluid away from the opening when the portion of the fluid permeable body is positioned adjacent to the female urethra while the fluid impermeable barrier is external to the vagina (¶0073 and 0138, lines 8-16), wherein the fluid impermeable barrier extends at least partially around the fluid permeable body (1530; ¶0134; 1630; ¶0138) and is at least partially positioned substantially opposite to the portion of the fluid permeable body that extends across at least the portion of the opening (Fig. 28, feats. 1504 and 1504A; Fig. 32, feats. 1604, 1604A, and 1630: fluid impermeable barrier 1504, 1604 has a portion positioned opposite the opening 1504A, 1604A and therefore opposite the portion of the permeable body 1530, 1630 which extends across the opening).
Sanchez discloses that the impermeable barrier is flexible and compliant so that the device can conform to differently shaped and/or sized users (¶0132 and 0138), but does not disclose the claimed shore A durometer hardness range of the impermeable barrier, the claimed thickness range of the fluid impermeable barrier, or that the portion of the fluid impermeable barrier having the claimed shore A durometer hardness range extends at least partially about the fluid permeable body and is at least partially positioned substantially opposite to the portion of the fluid permeable body that extends across at least the portion of the opening.
Davis teaches a supplemental spout (Figs. 6-8, feat. 140; ¶0040-0041) for a urine collection device (Fig. 2, feat. 110; ¶0030) which is made of a soft, pliable, and waterproof material which is advantageously durable enough to maintain its shape, but soft enough to prevent any injury to the user (¶0041). Davis teaches that such a material has a shore A durometer hardness from 1 to 20 (¶0041). This overlaps the claimed range of shore A durometer hardnesses of less than about 10, and therefore, a prima facie case of obviousness exists for the claimed range. Please see MPEP §2144.05(I). Additionally, because the supplemental spout of Davis is designed for fluid collection from a patient while any preventing injury to the patient, it is at least from the same field of endeavor as the claimed invention, as described in at least paragraph 0005 of the present specification. Please see MPEP §2141.01(a). Furthermore, as discussed above, Sanchez discloses that the fluid impermeable barrier has a portion which extends about the fluid permeable body and is positioned opposite to the portion of the fluid permeable body that extends across the opening, and modifying the fluid impermeable barrier of Sanchez to have a shore A durometer hardness in the range discussed by Davis would enable the fluid impermeable barrier to be durable enough to maintain its shape, but soft enough to prevent any injury to the user. 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 Sanchez so that at least the portion of the fluid impermeable barrier having a shore A durometer hardness of less than about 10 and so that the portion of the fluid impermeable barrier which extends at least partially about the fluid permeable body and is positioned substantially opposite to the portion of the fluid permeable body that extends across at least the portion of the opening has the shore A durometer hardness of about 2 to about 14 so that the fluid impermeable barrier is durable enough to maintain its shape, but soft enough to prevent any injury to the user as taught by Davis.
Sanchez in view of Davis is silent with respect to the thickness of the fluid impermeable barrier.
Kay teaches a female external incontinence device for collecting urine (Figs. 1-2, feat. 20; ¶0028) comprising an intravaginal component (38), an adhesive flange (24) for interfacing with the body, a housing (22) with a urine collection channel (28), and an outlet tube (46). The housing (22), urine collection channel (28), and outlet tube (46) remain outside the body during use (Fig. 11). Kay teaches that that housing (22) should be a thin, soft, pliable, membranous elastomeric material, such as polyurethane or polyisoprene, with a thickness between 0.002 in to 0.017 in (about 0.05 mm to about 0.43 mm) and a flexural modulus of elasticity of below 30,000 psi (about 207 MPa or about 134 kN/in2) (¶0036) in order to ensure that the housing is soft and pliable enough to conform to the body and be comfortable during use (¶0010 and 0028, lines 39-43). The prior art thickness range of between about 0.05 mm to about 0.43 mm overlaps the claimed thickness range of less than about 1.6 mm, and therefore a prima facie case exists for the claimed range. 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 Sanchez in view of Davis so that the fluid impermeable barrier has a thickness of less than about 1.6 mm defined between the inner surface and the outer surface in order to ensure that the fluid impermeable barrier is soft and pliable enough to conform to the body and be comfortable during use as taught by Kay.
Regarding claim 13, Sanchez in view of Davis and in further view of Kay suggests the device of claim 12. As discussed above, Kay teaches that the housing should have a flexural modulus of elasticity of below 30,000 psi (about 207 MPa or about 134 kN/in2), or 0 – 30,000 psi in other words, in order to ensure that the housing is soft and pliable enough to conform to the body and be comfortable during use (¶0010, 0028, lines 39-43, and 0036). The claimed modulus of elasticity range of about 4 N/in2 to 20 N/in2 lies within the prior art range of 0 – 134 kN/in2 taught by Kay, and therefore a prima facie case exists for the claimed range. 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 Sanchez in view of Davis and in further view of Kay so that the fluid impermeable barrier includes a modulus of elasticity of about 4 N/in2 to about 20 N/in2 in order to ensure that the housing is soft and pliable enough to conform to the body and be comfortable during use as taught by Kay (¶0010, 0028, lines 39-43, and 0036).
Regarding claim 16, Sanchez in view of Davis and in further view of Kay suggests the device of claim 12. As discussed above, Kay teaches that the thin elastomeric housing may be made of polyurethane (¶0036, lines 3-16). Therefore, Sanchez in view of Davis and in further view of Kay further suggests that the fluid impermeable barrier includes a polyurethane film.
Regarding claim 17, Sanchez in view of Davis and in further view of Kay suggests the device of claim 12, and Sanchez further discloses a conduit including an inlet and an outlet (Fig. 16, feat. 1621; ¶0138-0139: tube 1621 has its inlet near reservoir 1610 and outlet near aperture 1620), wherein at least a portion of the conduit (1621) extends through the aperture (1620) and into the chamber (1610), the fluid permeable body being configured to wick fluid away from the opening to the inlet (¶0073 and 0139: permeable membrane 1630 wicks fluid away from the user’s urethra and skin at opening 1604A such that it flows to the reservoir 1610 at the inlet of the conduit 1621).
Regarding claim 18, Sanchez in view of Davis and in further view of Kay suggests the device of claim 17, and Sanchez further discloses that the fluid permeable body (Fig. 32, feat. 1630) includes an outer surface (Annotated Fig. 28/32, feat. C) and no more than two layers of material between the opening (1604A) and the conduit (1621; layers between opening 1604A and conduit 1621 are fluid permeable body 1630 and fluid permeable support 1640); and the inner surface of the fluid impermeable barrier (Annotated Fig. 28/32, feat. A) interfaces the outer surface of the fluid permeable body (Annotated Fig. 28/32, feats. A and C: Impermeable barrier inner surface A is directly adjacent permeable body outer surface C).
Regarding claim 21, Sanchez in view of Davis in view of Kay discloses the device of claim 12. As discussed above, Davis teaches a supplemental spout (Figs. 6-8, feat. 140; ¶0040-0041) for a urine collection device (Fig. 2, feat. 110; ¶0030) which is made from a material having a shore A durometer hardness from 1 to 20 and is advantageously durable enough to maintain its shape, but soft enough to prevent any injury to the user (¶0041). The prior art range of 1 to 20 overlaps the claimed range of less than 5, and therefore, a prima facie case of obviousness exists for the claimed range. 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 Sanchez in view of Davis and in further view of Kay so that the fluid impermeable barrier has a shore A durometer of hardness of less than 5 so that the fluid impermeable barrier is durable enough to maintain its shape, but soft enough to prevent any injury to the user as taught by Davis.
Claims 22 and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez et al. (US 2017/0266031 A1) in view of Kay et al. (US 2011/0028922 A1).
Regarding claim 22, Sanchez discloses a fluid collection device (Figs. 27-31; ¶0132-0133; Figs. 32-33, feat. 1602; ¶0138-0139), comprising a fluid impermeable barrier (1504; 1604) configured to temporarily store fluids therein (¶0138-0139: fluid impermeable casing 1604 defines a reservoir 1610 to which fluid flows to and is stored before being suctioned out by tube 1621), the fluid impermeable barrier having an inner surface (Annotated Fig. 28/32, feat. A) at least partially defining a chamber (1510; 1610), an outer surface (Annotated Fig. 28/32, feat. B), an opening extending longitudinally along the fluid impermeable barrier (1504A; 1604A) and configured to be positioned adjacent to a female urethra of a female user while the fluid impermeable barrier is external to a vagina of the female user (Fig. 33; ¶0139, lines 1-5), and an aperture (1520; 1620) configured to receive a conduit therethrough (1621); wherein at least a portion of the fluid impermeable barrier extends from the inner surface of the fluid impermeable barrier (Annotated Fig. 28/32, feat. A) that defines the chamber (1510; 1610) to the outer surface of the fluid impermeable barrier (Annotated Fig. 28/32, feat. B); and a fluid permeable body positioned at least partially within the chamber and having a portion extending across at least a portion of the opening (1530; ¶0134; 1630; ¶0138) and configured to wick fluid away from the opening when the portion of the fluid permeable body is positioned adjacent to the female urethra while the fluid impermeable barrier is external to the vagina (¶0073 and 0138, lines 8-16), wherein the fluid impermeable barrier extends at least partially around the fluid permeable body (1530; ¶0134; 1630; ¶0138) and is at least partially positioned substantially opposite to the portion of the fluid permeable body that extends across at least the portion of the opening (Fig. 28, feats. 1504 and 1504A; Fig. 32, feats. 1604, 1604A, and 1630: fluid impermeable barrier 1504, 1604 has a portion positioned opposite the opening 1504A, 1604A and therefore opposite the portion of the permeable body 1530, 1630 which extends across the opening).
Sanchez discloses that the impermeable barrier is flexible and compliant so that the device can conform to differently shaped and/or sized users (¶0132 and 0138), but does not disclose the claimed range of modulus of elasticities, the claimed thicknesses of the fluid impermeable barrier, or that at least the portion of the fluid impermeable barrier having the claimed modulus of elasticity extends at least partially about the fluid permeable body and is at least partially positioned substantially opposite to the portion of the fluid permeable body that extends across at least the portion of the opening.
Kay teaches a female external incontinence device for collecting urine (Figs. 1-2, feat. 20; ¶0028) comprising an intravaginal component (38), an adhesive flange (24) for interfacing with the body, a housing (22) with an elongate opening (26) in fluid communication with a urine collection channel (28), and an outlet tube (46). During use, (Figs. 9-11; ¶0032-0035), the elongate opening (26) of the housing (22) is placed adjacent to the urethra (¶0034), with the walls of the urine collection channel (28) being opposite from the urethra (Fig. 11, feat. 28). Furthermore, the housing (22), urine collection channel (28), and outlet tube (46) remain outside the body during use (Fig. 11). Kay teaches that that housing (22) should be a thin, soft, pliable, membranous elastomeric material, such as polyurethane or polyisoprene, with a thickness between 0.002 in to 0.017 in (about 0.05 mm to about 0.43 mm), a flexural modulus of elasticity of below 30,000 psi (about 207 MPa or about 134 kN/in2), or 0 – 30,000 psi, and a shore A durometer hardness of less than 30 (¶0036) in order to ensure that the housing is soft and pliable enough to conform to the body and be comfortable during use (¶0010 and 0028, lines 39-43). The claimed modulus of elasticity range of about 4 N/in2 to 20 N/in2 lies within the prior art range of 0 – 134 kN/in2 taught by Kay, and therefore a prima facie case exists for the claimed range. Please see MPEP §2144.05(I). Similarly, the prior art thickness range of between about 0.05 mm to about 0.43 mm overlaps the claimed thickness range of about 0.2 mm to about 3.2 mm, and therefore a prima facie case exists for the claimed range. Modifying the fluid impermeable barrier of Sanchez to have the material properties taught by Kay would also grant those properties to the portion of the fluid impermeable body that is positioned opposite to the portion of the fluid permeable body that extends across the opening, which is adjacent to the urethra during use, because the housing of Kay comprises a portion (28) which is opposite from the opening (26) adjacent to the urethra which has those properties. 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 Sanchez in view of Kay so that the fluid impermeable barrier includes a modulus of elasticity of about 4 N/in2 to about 20 N/in2 and a thickness of about 0.2 mm to about 3.2 mm defined between the inner surface and the outer surface and so that at least the portion of the fluid impermeable barrier having the modulus of elasticity of about 4 N/in2 to about 20 N/in2 extends at least partially about the fluid permeable body and is at least partially positioned substantially opposite to the portion of the fluid permeable body that extends across at least the portion of the opening in order to ensure that the housing is soft and pliable enough to conform to the body and be comfortable during use as taught by Kay.
Regarding claims 24-25, Sanchez in view of Kay suggests the device of claim 22. As discussed above, Kay teaches a housing thickness between 0.002 in to 0.017 in (about 0.05 mm to about 0.43 mm) in order to ensure that the housing is soft and pliable enough to conform to the body and be comfortable during use (¶0010 and 0028, lines 39-43). The claimed thickness ranges of about 0.2 mm to about 3.2 mm, with respect to claim 23, and about 0.2 mm to about 1.6 mm, with respect to claim 24, and about 0.2 mm to about 0.8 mm, with respect to claim 25 overlaps the prior art range of about 0.05 mm to about 0.43 mm, and therefore a prima facie case exists for the claimed range. 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 Sanchez in view of Kay so that the fluid impermeable barrier has a thickness of about 0.2 mm to about 3.2 mm, with respect to claim 23, of about 0.2 mm to about 1.6 mm, with respect to claim 24, or of about 0.2 mm to about 0.8 mm, with respect to claim 25, in order to ensure that the housing is soft and pliable enough to conform to the body and be comfortable during use as taught by Kay (¶0010 and 0028, lines 39-43).
Regarding claim 26, Sanchez in view of Kay suggests the device of claim 22. As discussed above, Kay teaches that the thin elastomeric housing may be made of polyurethane (¶0036, lines 3-16). Therefore, Sanchez in view of Kay further discloses that the fluid impermeable barrier includes a polyurethane film.
Regarding claim 27, Sanchez in view of Kay suggests the device of claim 22, and Sanchez further discloses a conduit including an inlet and an outlet (Fig. 16, feat. 1621; ¶0138-0139: tube 1621 has its inlet near reservoir 1610 and outlet near aperture 1620), wherein at least a portion of the conduit (1621) extends through the aperture (1620) and into the chamber (1610), the fluid permeable body being configured to wick fluid away from the opening to the inlet (¶0073 and 0139: permeable membrane 1630 wicks fluid away from the user’s urethra and skin at opening 1604A such that it flows to the reservoir 1610 at the inlet of the conduit 1621).
Regarding claim 28, Sanchez in view of Kay suggests the device of claim 27, and Sanchez further discloses that the fluid permeable body (Fig. 32, feat. 1630) includes an outer surface (Annotated Fig. 28/32, feat. C) and no more than two layers of material between the opening (1604A) and the conduit (1621; layers between opening 1604A and conduit 1621 are fluid permeable body 1630 and fluid permeable support 1640); and the inner surface of the fluid impermeable barrier (Annotated Fig. 28/32, feat. A) interfaces with the outer surface of the fluid permeable body (Annotated Fig. 28/32, feats. A and C: Impermeable barrier inner surface A is directly adjacent permeable body outer surface C).
Claims 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez et al. (US 2017/0266031 A1) in view of Kay et al. (US 2011/0028922 A1) and in further view of Davis et al. (US 2015/0374535 A1).
Regarding claims 29-31, Sanchez in view of Kay suggests the device of claim 22 but does not disclose that the fluid impermeable barrier includes a shore A durometer hardness of less than about 15, with respect to claim 29, that the fluid impermeable barrier includes a shore A durometer hardness of less than about 10, with respect to claim 30, or that the fluid impermeable barrier includes a shore A durometer hardness of less than about 5, with respect to claim 31.
As discussed above, Davis teaches a supplemental spout (Figs. 6-8, feat. 140; ¶0040-0041) for a urine collection device (Fig. 2, feat. 110; ¶0030) which is made of a soft, pliable, and waterproof material which is advantageously durable enough to maintain its shape, but soft enough to prevent any injury to the user (¶0041). Davis teaches that such a material has a shore A durometer hardness from 1 to 20 (¶0041). This overlaps the claimed ranges of shore A durometer hardnesses of less than about 15, with respect to claim 29, of less than about 10, with respect to claim 30, and less than about 5, with respect to claim 31, and therefore, a prima facie case of obviousness exists for the claimed ranges. Please see MPEP §2144.05(I). Additionally, because the supplemental spout of Davis is designed for fluid collection from a patient while any preventing injury to the patient, it is at least from the same field of endeavor as the claimed invention, as described in at least paragraph 0005 of the present specification. Please see MPEP §2141.01(a). Furthermore, as discussed above, Sanchez discloses that the fluid impermeable barrier has a portion which extends about the fluid permeable body and is positioned opposite to the portion of the fluid permeable body that extends across the opening, and modifying the fluid impermeable barrier of Sanchez to have a shore A durometer hardness in the range discussed by Davis would enable the fluid impermeable barrier to be durable enough to maintain its shape, but soft enough to prevent any injury to the user. 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 Sanchez in view of Kay so that the fluid impermeable barrier includes a shore A durometer hardness of less than about 15, with respect to claim 29, that the fluid impermeable barrier includes a shore A durometer hardness of less than about 10, with respect to claim 30, or so that the fluid impermeable barrier includes a shore A durometer hardness of less than about 5, with respect to claim 31, so that the fluid impermeable barrier is durable enough to maintain its shape, but soft enough to prevent any injury to the user as taught by Davis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Moulton et al. (WO 2018/200721 A1) teaches a body conforming, soft, and durable lid for a fluid absorption and enteral access device.
Parks et al. (US 2003/0233079 A1) teaches a fluid collection device employing Dynaflex G6713 thermoplastic elastomer.
Kubo (US 5,295,983 A) teaches a urinary collector for women with a wall thickness of 0.5 mm to 5 mm.
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
/JESSICA ARBLE/Primary Examiner, Art Unit 3781