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
The amendments filled August 19, 2925, have been entered. Claims 1-10 and 13-35 are currently pending. Claims 1, 23, and 27 have been amended. Claim 35 has been newly added.
Response to Arguments
Applicant's arguments filed August 18, 2025, have been fully considered.
Regarding the 35 U.S.C. 112(b) rejection it has been withdrawn due to the remarks and as discussed in the interview held on July 28, 2025.
Regarding the remaining remarks which are drawn to the applicability of the current art to the amended subject the amendments require a new grounds of rejection.
Newly amended claims 1, 23 and 27 now require the impermeable barrier to be at least partially transparent. According to applicant’s specification (paragraph [0032]) materials that can be partially transparent are “polyethylene, polypropylene, polycarbonate, or polyvinyl chloride for example”. The primary reference Sharma makes no mention of transparency. However, Sharma in paragraphs [0127] does disclose the same material (“hermoplastics include but are not limited to: polyethylene, polypropylene, polyethylene terephthalate, polyamide, polyvinyl chloride, polyester, polyether, polyurethane, polytetrafluoroethylene, block-copolymer elastomers, polyamid”) for the sheath as applicant mentions in their specification as such the same material should have the same properties. Additionally, Lee US 3511241 teaches a urine collection system made from “polyethylene or the like which is transparent” so the user can observe the contents of the bag (Col 4 lines 35-45). Lee provides clear support for polyethylene being known to be transparent and motivation for using a transparent material.
Newly amended claims 1, 23, and 27, also now require the porous material to be only on one side of the penis receiving area extending at least from the opening to the fluid outlet. However, Palumbo has already been brought into address claim 30 which is narrower than the newly amended section regarding the porous material’s placement of “substantially occupying all of the chamber” and ability to lay flat and extend across the opening. Figure 3 of Palumbo clearly shows a porous material (15) on a single side of the collection system (10) which extends across the opening or aperture (13). No arguments were made regarding claim 30 or Palumbo’s applicability.
Claim 1 has additionally been amended to further distinguish the base has two portions. The first portion is attached to the sheath and the second portion extends beyond the sheath. Applicant’s specification notes the base may have a triangular shape such that a section of the base extends beyond the sheath area as seen in applicant figure 1c and paragraph [0059]. While the current claim language does not necessarily reflect the second portion of the base extend beyond the “footprint” of the sheath through the applicant-initiated interviews and the remarks it is clear this is what applicant is trying to claim. However, the Examiner is still unclear how this distinction is not also found in Sharma Figure 1c and 1d which shows the base extending beyond the footprint of the sheath thereby having a second portion that is not permanently secured to the proximal region of the sheath nor is the second portion secured to the proximal end of the sheath.
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5, 16-22, 27, 29-30, 32 and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma US 20230020563 A1 in view of Lee US 3511241 and Palumbo US 2003/0073964 A1.
Regarding claim 1, Sharma discloses a fluid collection assembly (abstract), comprising:
a sheath (or pouch, 2 figure 1A) including:
a fluid impermeable barrier ([0069] which discloses the pouch material is impermeable) including a proximal region (16, figure 1A) and a distal region (5, figure 1A) extending from the proximal region ([0079]), the proximal region including proximal edges opposite the distal region that are attached together, the proximal region exhibiting a first width and the distal region exhibiting a second width that is less than the first width, the proximal region defining an opening ([0079] which note the sheets are attached and figure 1A which shows different width in the distal and proximal regions), the fluid impermeable barrier at least defining a chamber ([0079] the pouch has two chambers/ fluid compartments 102 and 104) and a fluid outlet (both compartments have a fluid outlet at 44/24 respectively [0080] /[0084]);
a port attached to the fluid outlet (24, figure 1f and [0084]), the port including a first part defining an inlet and a second part defining an outlet (section not enclosed by the pouch- fig 1a), the first part attached to the fluid impermeable barrier and the second part extending from the first part (see fig 1a where the first part is attached to the pouch and second part resides outside of the pouch), the second part configured to be attached to a conduit (or drainage tube [0026]), the second part configured to be more rigid than the conduit ([0008] indicates the drainage tube/conduit is flexible for patient comfort and [0086] indicates the outlet conduit member 24/port can be rigid; as such, if the port is rigid and the drainage tube is flexible, the port will be more rigid than the conduit); and a base (8 figure 1A) secured to or configured to be secured to the proximal region of the sheath, the base configured to be attached to skin surrounding a penis, the base defining an aperture that corresponds to the opening of the sheath ([0082 and 0083]), the base including a first portion and a second portion (see figure below), the first portion permanently secured to or configured to the be secured to the proximal region of the sheath ([0083] details the adhesive base (8) allows for the device to be attached to the user, therefore the adhesive base must be attached to the sheath), the second portion of the base not permanently secured to the proximal region of the sheath or the second portion of the base is configured to not be permanently secured to the proximal region of the sheath, wherein the first portion and the second portion are immediately adjacent and abut the sheath (see figure below).
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Sharma fails to disclose at least one porous material in the chamber, the at least one porous material being a sheet; wherein the fluid impermeable barrier and the at least one porous material directly define a penis receiving area extending from at least the opening to the fluid outlet, the at least one porous material only positioned on one side of the penis receiving area, and wherein at least a portion of the fluid impermeable barrier directly defining the penis receiving area is at least partially transparent.
Sharma fails to disclose the partial transparency of the impermeable barrier. According to applicant’s specification (paragraph [0032]) materials that can be partially transparent are “polyethylene, polypropylene, polycarbonate, or polyvinyl chloride for example”. The primary reference Sharma makes no mention of transparency. However, Sharma in paragraphs [0127] does disclose the same material (“hermoplastics include but are not limited to: polyethylene, polypropylene, polyethylene terephthalate, polyamide, polyvinyl chloride, polyester, polyether, polyurethane, polytetrafluoroethylene, block-copolymer elastomers, polyamid”) for the sheath as applicant mentions in their specification as such the same material should have the same properties. Additionally, Lee US 3511241 teaches a urine collection system made from “polyethylene or the like which is transparent” so the user can observe the contents of the bag (Col 4 lines 35-45). Lee provides clear support for polyethylene being known to be transparent and motivation for using a transparent material.
Therefore, it would have obvious to one of ordinary skill in the art before the effective filing date to have made the sheath to be at least partially transparent in order to obverse the urine as taught by Lee. Additionally, Lee supports the material itself is known to be transparent.
Sharma and Lee still fail to disclose in combination at least one porous material in the chamber, the at least one porous material being a sheet; wherein the fluid impermeable barrier and the at least one porous material directly define a penis receiving area extending from at least the opening to the fluid outlet, the at least one porous material only positioned on one side of the penis receiving area.
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as Sharma. Palumbo teaches a urine porous material (or absorbent, 15, figure 3) disposed within a sleeve (formed by 11); the porous material extending from a proximal end to a distal end of the sleeve and therefore configured to extend across the opening when the sheath is resting on a flat surface and a penis is not disposed in the chamber (fig 3, additionally no structures are present that prevent the flattening of Palumbo when not in use).
It would have been obvious to one of ordinary skill before the effective filling date to have added the absorbent material of Palumbo to the device of Sharma to help keep the user dry prior the bag being emptied. One of ordinary skill would have found it obvious to try extending/positioning the absorbent as suggested by Palumbo with a reasonable expectation of success of collecting and retaining urine from the male member. Additionally, the penis can move through a range of angles throughout the day; thereby, making it obvious to position the material in a way that would cover the range of possible movement rather than solely at the lower half of the collection bag, as such the gaps will overlap or align with the gaps in the base of Sharma.
Regarding claim 2, Sharma discloses wherein the fluid impermeable barrier includes a first panel and a second panel attached to the first panel ([0079] discloses multiple sheets maybe used to form the pouch).
Regarding claim 3, Sharma discloses wherein the fluid impermeable barrier includes a first panel and a second panel integrally formed together ([0079] discloses multiple sheets maybe used to form the pouch to function as an integral unit).
Regarding claim 4, Sharma discloses wherein the fluid impermeable barrier includes polyurethane ([0081] discloses polyurethane maybe used).
Regarding claim 5, Sharma discloses wherein the first width is substantially constant and the second width decreases from the proximal region towards the fluid outlet (see figure 1A).
Regarding claim 16, Sharma discloses wherein the base includes a nonwoven substrate ([0144] which notes a non-woven base).
Regarding claim 17, Sharma discloses wherein the base defines one or more base gaps therein (see figures 19f-l which show various gaps on the base).
Regarding claim 18, Sharma fails to disclose wherein the at least one porous material defines one or more porous material gaps extending therethrough, wherein the one or more porous material gaps are generally aligned with the one or more base gaps.
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as the instant claims. Palumbo teaches a urine porous material (or absorbent, 15, figure 3, a porous material will inherently have gaps. as such the gaps will overlap or align with the gaps in the base of Sharma).
It would have been obvious to one of ordinary skill before the effective filling date to have added the absorbent material of Palumbo to the device of Sharma to help keep the user dry prior the bag being emptied. One of ordinary skill would have found it obvious to try extending/positioning the absorbent as suggested by Palumbo with a reasonable expectation of success of collecting and retaining urine from the male member. Additionally, the penis can move through a range of angles throughout the day; thereby, making it obvious to position the material in a way that would cover the range of possible movement rather than solely at the lower half of the collection bag, as such the gaps will overlap or align with the gaps in the base of Sharma.
Regarding claim 19, Sharma discloses wherein opposing portions of the fluid impermeable barrier that are generally aligned with the one or more base gaps and the one or more porous material gaps are attached together ([0079] notes all the layer are attached together).
Regarding claim 20, Sharma discloses wherein the base include an inner region adjacent to the aperture and an outer region spaced from the aperture by the inner region, and wherein the inner region is attached to the fluid impermeable barrier and the outer region is not attached to the fluid impermeable barrier ( see figure 1 which shows are area of the base (8) is outside of the impermeable barrier/ pouch 2) therefore it is not attached in that area).
Regarding claim 21, Sharma discloses wherein the base includes one or more concave edges (see the concave edges in figure 1A).
Regarding claim 22, Sharma discloses a vacuum source configured to apply a vacuum force (189 bulb syringe which draws a manual vacuum, [0130]; a fluid storage container (252, [0130]); and at least one conduit (189’’ figure 13A) connected to the outlet and in fluid communication with the vacuum source and the fluid storage container ([0130]).
Regarding claim 27, Sharma discloses a method of using the device ([0154]) attaching the base to skin surrounding a penis, the base secures to or configured to be secured to a sheath, the sheath comprising: ([0082 and 0083])
the sheath(or pouch, 2 figure 1A) including: a fluid impermeable barrier ([0069] which discloses the pouch material is impermeable) including a proximal region (16, figure 1A) and a distal region (5, figure 1A) extending from the proximal region ([0079]), the proximal region including proximal edges opposite the distal region that are attached together, the proximal region exhibiting a first width and the distal region exhibiting a second width that is less than the first width, the proximal region defining an opening ([0079] which note the sheets are attached and figure 1A which shows different width in the distal and proximal regions), the fluid impermeable barrier at least defining a chamber ([0079] the pouch has two chambers/ fluid compartments 102 and 104) and a fluid outlet (both compartments have a fluid outlet at 44/24 respectively [0080] /[0084]);
a port attached to the fluid outlet (24, figure 1f and [0084]), the port including a first part defining an inlet and a second part defining an outlet(section not enclosed by the pouch- fig 1a), the first part attached to the fluid impermeable barrier and the second part extending from the first part (see fig 1a where the first part is attached to the pouch and second part resides outside of the pouch), the second part configured to be attached to a conduit (or drainage tube [0026]), the second part configured to be more rigid than the conduit ([0008] indicates the drainage tube/conduit is flexible for patient comfort and [0086] indicates the outlet conduit member 24/port can be rigid; as such, if the port is rigid and the drainage tube is flexible, the port will be more rigid than the conduit), the first part exhibiting a first maximum thickness and the second part exhibiting a second maximum thickness, wherein the first maximum thickness is substantially equal to or less than the second maximum thickness (24, figure 1f and [0084] which shoes the port being the same thickness); a base (8 figure 1A)secured to or configured to be secured to the proximal region of the sheath.
Sharma fails to disclose at least one porous material in the chamber, the at least one porous material being a sheet; wherein the fluid impermeable barrier and the at least one porous material directly define a penis receiving area extending from at least the opening to the fluid outlet, the at least one porous material only positioned on one side of the penis receiving area, and wherein at least a portion of the fluid impermeable barrier directly defining the penis receiving area is at least partially transparent.
Sharma fails to disclose the partial transparency of the impermeable barrier. According to applicant’s specification (paragraph [0032]) materials that can be partially transparent are “polyethylene, polypropylene, polycarbonate, or polyvinyl chloride for example”. The primary reference Sharma makes no mention of transparency. However, Sharma in paragraphs [0127] does disclose the same material (“hermoplastics include but are not limited to: polyethylene, polypropylene, polyethylene terephthalate, polyamide, polyvinyl chloride, polyester, polyether, polyurethane, polytetrafluoroethylene, block-copolymer elastomers, polyamid”) for the sheath as applicant mentions in their specification as such the same material should have the same properties. Additionally, Lee US 3511241 teaches a urine collection system made from “polyethylene or the like which is transparent” so the user can observe the contents of the bag (Col 4 lines 35-45). Lee provides clear support for polyethylene being known to be transparent and motivation for using a transparent material.
Therefore, it would have obvious to one of ordinary skill in the art before the effective filing date to have made the sheath to be at least partially transparent in order to obverse the urine as taught by Lee. Additionally, Lee supports the material itself is known to be transparent.
Sharma and Lee still fail to disclose in combination at least one porous material in the chamber, the at least one porous material being a sheet; wherein the fluid impermeable barrier and the at least one porous material directly define a penis receiving area extending from at least the opening to the fluid outlet, the at least one porous material only positioned on one side of the penis receiving area.
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as Sharma. Palumbo teaches a urine porous material (or absorbent, 15, figure 3) disposed within a sleeve (formed by 11); the porous material extending from a proximal end to a distal end of the sleeve and therefore configured to extend across the opening when the sheath is resting on a flat surface and a penis is not disposed in the chamber (fig 3, additionally no structures are present that prevent the flattening of Palumbo when not in use).
It would have been obvious to one of ordinary skill before the effective filling date to have added the absorbent material of Palumbo to the device of Sharma to help keep the user dry prior the bag being emptied. One of ordinary skill would have found it obvious to try extending/positioning the absorbent as suggested by Palumbo with a reasonable expectation of success of collecting and retaining urine from the male member. Additionally, the penis can move through a range of angles throughout the day; thereby, making it obvious to position the material in a way that would cover the range of possible movement rather than solely at the lower half of the collection bag, as such the gaps will overlap or align with the gaps in the base of Sharma.
Regarding claim 29 and 34, Sharma discloses wherein the fluid impermeable barrier defines a single chamber per claim 29 and wherein the fluid impermeable barrier defines an interior region extending between the proximal region to the distal region, the interior region consisting of a single chamber per claim 34 (figure 1c, while Sharma has a chamber enclosed within a chamber, both are single chambers as neither has a partition which divides into two or more sections).
Regarding claim 30, Sharma as modified by Palumbo in claim 1 discloses wherein the at least one porous material occupies substantially all of the chamber when the fluid collection assembly lies on the flat surface (Palumbo fig 3).
Regarding claim 32, Sharma as modified by Palumbo in claim 1 discloses wherein the sheet of the at least one porous material extends across the opening when the fluid collection assembly lies on a flat surface (Palumbo fig 3).
Regarding claim 35, Sharma as modified by Palumbo in claim 1 discloses wherein the at least one porous material includes a single sheet extending an entire length of the sheath (Palumbo fig 3).
Claim(s) 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma US 20230020563 A1 in view of Lee US 3511241 and Palumbo US 2003/0073964 A1 and in further view of Fuijioka EP 0787472.
Regarding claim 6, Sharma, Lee, and Palumbo fail to disclose wherein the second width decreases at a constant rate.
Fuijioka teaches a urine bag (abstract) thereby being in a relate field of endeavor as Sharma and Becker. Fuijioka teaches a urine bag wherein the second width decreases at a constant rate (figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have changed the shape of the bag of Sharma to be tapered like Fuijioka. This provides a narrower profile to reduce bulk thereby lessening perceived user embracement with a bulky urine collector that could be visible under the user’s clothes. Furthermore, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) that states that change of shape was matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.
Regarding claim 10, Sharma and Langstrom fail to disclose wherein the at least one porous material exhibits a shape that generally corresponds to a shape of the first portion and the second portion of the fluid impermeable barrier.
Fuijioka teaches a urine bag with an absorbent pad (or porous material) (abstract) thereby being in a relate field of endeavor as Sharma and Becker. Fuijioka teaches porous material exhibits a shape that generally corresponds to a shape of the first portion and the second portion of the fluid impermeable barrier (figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have changed the shape of the bag and thereby porous material of Sharma to be tapered like Fuijioka. This provides a narrower profile to reduce bulk thereby lessening perceived user embracement with a bulky urine collector that could be visible under the user’s clothes. Furthermore, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) that states that change of shape was matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.
Claim(s) 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma US 20230020563 A1 in view of Lee US 3511241 and Palumbo US 2003/0073964 A1 as applied to claim 1 above, and further in view of Pinlac US20210121318 A1.
Regarding claim 7, Sharma, Lee, and Palumbo fail to disclose the fluid impermeable barrier defines one or more orifices extending therethrough; and the sheath further includes one or more vents attached to the fluid impermeable barrier and covering the one or more orifices, the one or more vents configured to allow air to flow therethrough and prevent water flowing therethrough.
Pinlac teaches a urine collection device thereby being in the same field of endeavor as Sharma and Becker. Pinlac teaches the use of a vent to enable airflow and reduce moister (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added a vent to the device of Sharma in order to provide better airflow and moister build-up prevention.
Regarding claim 9, Sharma, Lee, Palumbo, and Pinlac fail to disclose wherein the one or more orifices and the one or more vents exhibits an elongated shape.
However, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) that states that change of shape was matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.
It would have been obvious to change the shape of the vent from a circle to an elongated shape given applicant notes the as “an example the shape may exhibit an elongated shape” emphases on may as applicant then proceeds to note an effect of the elongated shape on page 11.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma US 20230020563 A1 in view of Lee US 3511241 and Palumbo US 2003/0073964 A1.and Pinlac US 20210121318 A1 as applied to claim 7 above, and further in view of Levin US 20220229053 A1.
Regarding claim 8, Sharma, Lee, Palumbo, and Pinlac fail to disclose wherein the one or more vents includes a porous polytetrafluoroethylene layer attached to a substrate, the substrate attached to the fluid impermeable barrier.
Levin teaches a device that handles and tests fluid with a cartridge ([0131]) with a vent ([0144]) thereby being drawn to a similar problem. Levin teaches the cartridge maybe formed from a polymer [0131] and the vent can be form by polytetrafluoroethylene. While Levin fails to teach an intermediate substrate, the two materials must be attached by some means.
It would have been obvious to one of ordinary skill in the art to have formed vent out of polytetrafluoroethylene as it repels liquid while allowing vapor to pass.
Claim(s) 13-15, 23-26, 28 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma US 20230020563 A1 in view of Lee US 3511241 and Palumbo US 2003/0073964 A1 and in further view of Brosch US 20180021218 A1.
Regarding claim 13, Sharma, Lee, and Palumbo fail to disclose wherein the first part exhibits a first width and the second part exhibits a second width, the first width at least two times greater than the second width.
Regarding claim 14, Sharma, Lee, and Palumbo fail to disclose wherein the first part defines sink upstream from the inlet, the sink exhibiting at least one of a width or thickness that is greater than a corresponding width or thickness of the inlet.
Regarding claim 15, Sharma, Lee, and Palumbo to disclose wherein the port includes at least one tab extending from the first part, the at least one tab extending further into the chamber than a remainder of the port.
Regarding claim 28, Sharma, Lee, and Palumbo to disclose wherein the sink includes at least one tapered surface extending from a maximum width of the sink to the inlet.
Regarding claims 13-15 and 28: Brosch teaches a bag (100) assembly with a fitment (or port) (200) (abstract) thereby being drawn to solve a similar problem as Sharma as all inventions are related by being a bag with a discharge outlet. Brosch teaches the fitment (or port 200) has a first part (210, figure 2A) that has an elongated section and resides within the bag (100) and has a second section (220, figure 2A) which is narrower and can be attached to tubing ([0055] for placement and alternate shapes of the fitment within the bag and [0059] which notes the first and second part of fitment). Brosch teaches the first width is at least two times greater than the second width (figure 3B) and that the first part has a sink or opening that is greater than the second part (figure 3A and [0065]). Brosch teaches the sink includes at least one tapered surface extending from a maximum width of the sink to the inlet (see fig. 2e which shows a possible configuration for the interior lumen/ flow path inside the port having a tapered surface).
Annotated figure for claim 15 below:
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It would have been obvious to one of ordinary skill in the art before the effective filling date to have made a port of Sharma with a wider opening at the first end to better direct the fluid to the outlet point as taught by Brosch to allow for better flow (Brosch-cross section Figure 3b and [0059] as this paragraph support the opening be sized accommodate the outlets and the figure is reminiscent of funnel shape which directs fluid to a point). Please keep in mind claims 14 and 15 both depend from claim 1 therefor the same structure can be used in two different interpretations.
Regarding claim 23 and 24, Sharma discloses attaching together a fluid impermeable barrier ([0069] which discloses the pouch material is impermeable) including a proximal region (16, figure 1A) and a distal region (5, figure 1A) extending from the proximal region ([0079]), the proximal region including proximal edges/outer periphery opposite the distal region that are attached together, the proximal region exhibiting a first width and the distal region exhibiting a second width that is less than the first width, the proximal region defining an opening ([0079] which note the sheets are attached and figure 1A which shows different width in the distal and proximal regions), the fluid impermeable barrier at least defining a chamber ([0079] the pouch has two chambers/ fluid compartments 102 and 104) and a fluid outlet (both compartments have a fluid outlet at 44/24 respectively [0080] /[0084]); wherein the fluid impermeable barrier includes a first panel and a second panel attached to the first panel ([0079] discloses multiple sheets maybe used to form the pouch); and wherein the base is attached to the second panel (fig 1-d shows the attachment of the base (8) to the second panel (104’))
a port attached to the fluid outlet (24, figure 1f and [0084]), the port including a first part defining an inlet and a second part defining an outlet (section not enclosed by the pouch- fig 1a), the first part attached to the fluid impermeable barrier and the second part extending from the first part (see fig 1a where the first part is attached to the pouch and second part resides outside of the pouch), the second part configured to be attached to a conduit (or drainage tube [0026]), the second part configured to be more rigid than the conduit ([0008] indicates the drainage tube/conduit is flexible for patient comfort and [0086] indicates the outlet conduit member 24/port can be rigid; as such, if the port is rigid and the drainage tube is flexible, the port will be more rigid than the conduit), the first part exhibiting a first maximum thickness and the second part exhibiting a second maximum thickness, wherein the first maximum thickness is substantially equal to or less than the second maximum thickness (24, figure 1f and [0084] which shows the port being the same thickness); a base (8 figure 1A) secured to or configured to be secured to the proximal region of the sheath and attaching the base to the fluid impermeable sheath ([0082 and 0083]).
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Sharma fails to disclose at least one porous material in the chamber, the at least one porous material being a sheet; wherein the fluid impermeable barrier and the at least one porous material directly define a penis receiving area extending from at least the opening to the fluid outlet, the at least one porous material only positioned on one side of the penis receiving area, and wherein at least a portion of the fluid impermeable barrier directly defining the penis receiving area is at least partially transparent.
Sharma fails to disclose the partial transparency of the impermeable barrier. According to applicant’s specification (paragraph [0032]) materials that can be partially transparent are “polyethylene, polypropylene, polycarbonate, or polyvinyl chloride for example”. The primary reference Sharma makes no mention of transparency. However, Sharma in paragraphs [0127] does disclose the same material (“hermoplastics include but are not limited to: polyethylene, polypropylene, polyethylene terephthalate, polyamide, polyvinyl chloride, polyester, polyether, polyurethane, polytetrafluoroethylene, block-copolymer elastomers, polyamid”) for the sheath as applicant mentions in their specification as such the same material should have the same properties. Additionally, Lee US 3511241 teaches a urine collection system made from “polyethylene or the like which is transparent” so the user can observe the contents of the bag (Col 4 lines 35-45). Lee provides clear support for polyethylene being known to be transparent and motivation for using a transparent material.
Therefore, it would have obvious to one of ordinary skill in the art before the effective filing date to have made the sheath to be at least partially transparent in order to obverse the urine as taught by Lee. Additionally, Lee supports the material itself is known to be transparent.
Sharma and Lee still fail to disclose in combination at least one porous material in the chamber, the at least one porous material being a sheet; wherein the fluid impermeable barrier and the at least one porous material directly define a penis receiving area extending from at least the opening to the fluid outlet, the at least one porous material only positioned on one side of the penis receiving area.
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as Sharma. Palumbo teaches a urine porous material (or absorbent, 15, figure 3) disposed within a sleeve (formed by 11); the porous material extending from a proximal end to a distal end of the sleeve and therefore configured to extend across the opening when the sheath is resting on a flat surface and a penis is not disposed in the chamber (fig 3, additionally no structures are present that prevent the flattening of Palumbo when not in use).
It would have been obvious to one of ordinary skill before the effective filling date to have added the absorbent material of Palumbo to the device of Sharma to help keep the user dry prior the bag being emptied. One of ordinary skill would have found it obvious to try extending/positioning the absorbent as suggested by Palumbo with a reasonable expectation of success of collecting and retaining urine from the male member. Additionally, the penis can move through a range of angles throughout the day; thereby, making it obvious to position the material in a way that would cover the range of possible movement rather than solely at the lower half of the collection bag, as such the gaps will overlap or align with the gaps in the base of Sharma.
Sharma, Lee, and Palumbo fail to disclose the port’s first part exhibiting an elongated shape that extends in a direction that is generally perpendicular to a longitudinal axis of the fluid collection assembly.
Brosch teaches a bag (100) assembly with a fitment (or port) (200) (abstract) thereby being drawn to solve a similar problem as Sharma and Becker as all inventions are related by being a bag with a discharge outlet. Brosch teaches the fitment (or port 200) has a first part (210, figure 2A) that has an elongated section and resides within the bag (100) and has a second section (220, figure 2A) which is narrower and can be attached to tubing ([0055] for placement and alternate shapes of the fitment within the bag and [0059] which notes the first and second part of fitment).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have made a port of Sharma with a wider opening at the first end to better direct the fluid to the outlet point as taught by Brosch to allow for better flow (Brosch-cross section Figure 3b and [0059] as this paragraph support the opening be sized accommodate the outlets and the figure is reminiscent of funnel shape which directs fluid to a point).
Regarding claim 25, Sharma discloses wherein attaching the base to the second panel is performed before attaching at least a portion of the outer periphery of the first panel to the outer periphery of the second panel ([0144], fig 1d).
Regarding claim 26, Sharma discloses attaching opposing portions of the fluid impermeable barrier that are generally aligned with the one or more base gaps and the one or more porous material gaps are attached together ([0079] notes all the layer are attached together).
Sharma, Lee, and Brosch fail to disclose wherein the at least one porous material defines one or more porous material gaps extending therethrough, wherein the one or more porous material gaps are generally aligned with the one or more base gaps.
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as the instant claims. Palumbo teaches a urine porous material (or absorbent, 15, figure 3, a porous material will inherently have gaps. as such the gaps will overlap or align with the gaps in the base of Sharma).
It would have been obvious to one of ordinary skill before the effective filling date to have added the absorbent material of Palumbo to the device of Sharma to help keep the user dry prior the bag being emptied. One of ordinary skill would have found it obvious to try extending/positioning the absorbent as suggested by Palumbo with a reasonable expectation of success of collecting and retaining urine from the male member. Additionally, the penis can move through a range of angles throughout the day; thereby, making it obvious to position the material in a way that would cover the range of possible movement rather than solely at the lower half of the collection bag, as such the gaps will overlap or align with the gaps in the base of Sharma.
Regarding claim 33 Sharma, Lee, and Palumbo fail to teach wherein the first part of the port exhibits an elongated shape that extends in a direction that is generally perpendicular to a longitudinal axis of the fluid collection assembly, the first part exhibiting a first maximum thickness and the second part exhibiting a second maximum thickness, wherein the first maximum thickness is substantially equal to or less than the second maximum thickness.
Brosch teaches a bag (100) assembly with a fitment (or port) (200) (abstract) thereby being drawn to solve a similar problem as Sharma and Becker as all inventions are related by being a bag with a discharge outlet. Brosch teaches the fitment (or port 200) has a first part (210, figure 2A) that has an elongated section and resides within the bag (100) and has a second section (220, figure 2A) which is narrower and can be attached to tubing ([0055] for placement and alternate shapes of the fitment within the bag and [0059] which notes the first and second part of fitment).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have made a port of Sharma with a wider opening at the first end to better direct the fluid to the outlet point as taught by Brosch to allow for better flow (Brosch-cross section Figure 3b and [0059] as this paragraph support the opening be sized accommodate the outlets and the figure is reminiscent of funnel shape which directs fluid to a point).
Claim(s) 31 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma US 20230020563 A1 in view of Lee US 3511241 and Palumbo US 2003/0073964 A1 per claim 1 and in further view of Kubo US 5300052.
Regarding claim 31, Sharma, Lee, and Palumbo fail to disclose wherein the at least one porous material exhibits substantially no absorption.
Kubo teaches a urine collection system (abstract) thereby being in the same field as the instant claims. Kubo teaches the porous material exhibits substantially no absorption (Col 4 lines 15-20 notes a hydrophobic material which will not absorb and per Col 6 lines 50-67 which allows the urine to pass through the bag better).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added the hydrophobic material of Kubo to Sharma to help urine flow out of the collection container.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
CN116096332 has an effective filling date that predates the current application. It has some identical figures to the present application; however, the inventors are different. It appears to be related to application 18003029 which is held by the same assignee; therefore, CN116096332 appears to not be eligible prior art under exception 102(b)(1)(A).
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.
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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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