DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 26th, 2026 has been entered.
Claim Status
Claims 1, 3-5, 7-14,16-23, and 26-30 are currently pending and under consideration. Claims 2, 6, 15, and 24-25 remain cancelled. Claims 1,12,17,18,22, and 27 have been amended. Claims 28-30 have been newly added. All previously presented 112 rejections have been overcome.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18 and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites the limitation "the first end" in line 19. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitations of “an internal volume” in line 3 and “the internal volume” in line 4. It is unclear as to whether this is referring to the internal volume introduced in claim 1 or an additional internal volume introduced as introduced in claim 27. For the purposes of examination both instances of “internal volume” present in claim 27 are being taken to refer to an internal volume formed by an exterior-facing surface of the interior layer rather than the internal volume formed by an interior-facing surface of the interior layer as introduced in claim 1.
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.
Claim(s) 1, 3-5, 7-13, 16-20, 22-23, 27, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kharkar et al. (U.S. Publication 2022/0265461) in view of Sharma et al. (U.S. Publication 2021/0353449).
Regarding claim 1, Kharkar discloses A urine collection device (1800 utilizing fluid collection device 800 as detailed in ¶0192), comprising: a receptacle 812 including:
an interior layer 890E including an interior-facing surface (surface facing away from layer 890A) and an exterior-facing surface (surface facing toward layer 890A) opposite the interior-facing surface, the interior-facing surface of the interior layer at least partially defining an interior volume (interior volume consists of space between layers 890A and 890B comprising chambers 838A and 838B); interior layer 890E defines the portion of the interior volume that it occupies), the interior volume configured to receive a penis of a user (¶0131 penis is inserted by a user through opening 836, the penis contacts the permeable layer 890D in the first chamber); and
an exterior layer 890A fixed to the interior layer (Fig. 8S shows the fixation of each of the layers in place between exterior layers 890A and B), the exterior layer at least partially defining one or more channels (channel 838A);
an air inlet 1844 in fluid communication with the interior volume (Fig. 18D shows vent hole in fluid communication with fluid collection 1812 which is in fluid communication with interior volume of 800)
an outlet 830 in fluid communication with the interior volume (¶0135 outlet for egressing urine from the internal cavity), the outlet being formed within the receptacle and configured to enable extraction of fluid from the receptacle (¶0136 tube 879 extends through a seam 899 at the distal end of the collection member 812 and therefore formed within the receptacle; ¶0135 outlet for egressing urine from the internal cavity);
an exterior fluid permeable layer 890D positioned between at least a portion of the exterior-facing surface of the interior layer and at least a portion of the exterior layer (Fig. 8A exterior fluid permeable layer can be seen to be positioned between 890A and 890E); the exterior fluid permeable layer spaced from the interior volume by the interior layer (spaced from chamber 838B by interior layer); and
an interior fluid permeable layer (890C; ¶0130 includes a plurality of perforations 892 through which the first chamber communicates with the second chamber) positioned within the interior volume (positioned in the interior volume to separate internal volume into first and second chambers ¶0130 inner wall 890C separates the first chamber from the second chamber), the interior fluid permeable layer covering only a portion of the interior-facing surface (does not cover portion of interior-facing surface at locations of perforations 892); wherein the channel is configured to direct fluids received into the interior volume towards the outlet (channel 838A receives urine that is then directed by impermeable wall 890A to further layers 890D,E,C to 894 and out through outlet 830).
Kharkar does not expressly disclose the air inlet being at least partially defined by the receptacle.
However, Sharma in the same field of endeavor of urine collection devices, teaches providing an air inlet 30 in fluid communication with an internal volume (¶0127 internal compartment, the second wall or first wall may have air ports to allow ambient air to be drawn into the pouch) that is defined by (¶0127) a receptacle 2 for the purpose of allowing ambient air to be drawn into the pouch to facilitated air flow through the pouch for the purpose of drawing urine away from the tip of the penis and in the direction of a fluid inlet 15 of an outlet tubing 14 (¶0122 the air flow thus generated additional serves to draw urine away from the tip of the penis and in the direction of the fluid inlets. Maintaining the suction and consequent air flow results in urine within the pouch being quickly drawn out and resultant dehumidification/drying of the pouch).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the receptacle of Kharkar to have included an air inlet in fluid communication with the internal volume that is defined by the receptacle as taught by Sharma for the purpose of allowing ambient air to be drawn into the pouch to facilitated air flow through the pouch for the purpose of drawing urine away from the tip of the penis and in the direction of a fluid inlet 15 of an outlet tubing 14 (¶0122 the air flow thus generated additional serves to draw urine away from the tip of the penis and in the direction of the fluid inlets. Maintaining the suction and consequent air flow results in urine within the pouch being quickly drawn out and resultant dehumidification/drying of the pouch).
Regarding claim 3, Kharkar in view of Sharma suggest the urine collection device of claim 1. Kharkar further discloses wherein: the interior layer defines one or more apertures through which urine can exit the interior volume (¶0134 made from a mechanically absorbent polyester mesh material, mesh discloses multiple apertures that allow for fluid flow through the material); and the collection member being suitable to direct urine from the first chamber to the second chamber and direct the urine in the second chamber distally toward the outlet,
Kharkar does not expressly disclose whether the outer layers 890A and 890B are fluid impermeable.
However, Sharma, in the same field of endeavor of urine collection devices, discloses making the front and back layers of the device out of liquid impermeable material (¶0152 liquid impermeable) and sealing them together for the purpose of configuring the device to be liquid impermeable and essentially enclosed to provide a receiving area to receive urine and at least temporarily hold urine within the enclosed space (¶0152).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of 890A and 890B that performs the function of directing urine through the chambers of the devices to an outlet for the fluid impermeable material of Sharma since these elements perform the same function of providing a suitable material to direct fluid such that fluid does not leak from the material. Simply substituting one fluid directing material means for another would yield the predictable result of allowing a(n) urine collection assembly to collect urine through a directed fluid pathway without leaking out of the collection assembly. See MPEP 2143.
Regarding claim 4, Kharkar in view of Sharma suggest the urine collection device of claim 1. Kharkar further discloses the interior fluid permeable layer overlaying the one or more apertures (interior fluid permeable layer overlays the interior layer and would thus overlay the fluid pathway apertures).
Regarding claim 5,Kharkar in view of Sharma suggest the urine collection device of claim 4. Kharkar further discloses the interior fluid permeable layer being retained within the interior volume by coupling sheets together for instance through radio frequency heat sealing (¶0092), but does not expressly disclose the retainment being by an adhesive.
However, Sharma, in the same field of endeavor of urine collection devices, teaches bonding sheets together with an adhesive or thermal bonding ¶0133.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the welded bond of Kharkar that performs the function of joining sheets together for the adhesive bond of Sharma since these elements perform the same function of bonding two urine collection device layers together. Simply substituting one bonding means for another would yield the predictable result of allowing a(n) urine collection device layer to bonded in place with the other accompanying layers. See MPEP 2143.
Regarding claim 7, Kharkar in view of Sharma suggest the urine collection device of claim 1. Kharkar further discloses the outlet being in fluid communication with a suction device (¶0139 vacuum pressure applied by a vacuum device at the outlet 830)
Regarding claim 8, Kharkar in view of Sharma suggest the urine collection device of claim 7. Kharkar further discloses the outlet being configured to receive and retain a tube of the suction device (¶0137 couple the port with the drain tube, thus configured to receive and retain drain tube; ¶0114 links drain tube to vacuum device)
Regarding claim 9, Kharkar in view of Sharma suggest the urine collection device of claim 1. Kharkar further discloses the receptacle forming a rim (896A, 818A and 818B) surrounding a periphery of the receptacle (surround periphery 824) , the rim having a planar surface that interfaces with a region surrounding the penis of a user (Fig. 8A shows flat configuration, penis when inserted in 824 surrounded by flat surfaces of 818A and B).
Regarding claims 10 and 11, Kharkar in view of Sharma suggest the urine collection device of claim 1. Kharkar in view of Sharma further suggest the air inlet including an umbrella check valve 45b.
Regarding claim 12, Kharkar discloses a system for transporting urine away from a penis of a user (1800 utilizing fluid collection device 800 as detailed in ¶0192), the system comprising:
a receptacle 812 including:
an interior layer 890E including an interior-facing surface (surface facing away from layer 890A) and an exterior-facing surface (surface facing toward layer 890A) opposite the interior-facing surface, the interior-facing surface of the interior layer at least partially defining an interior volume (interior volume consists of space between layers 890A and 890B comprising chambers 838A and 838B); interior layer 890E defines the portion of the interior volume that it occupies), the interior volume configured to receive a penis of a user (¶0131 penis is inserted by a user through opening 836, the penis contacts the permeable layer 890D in the first chamber); and
an exterior layer 890A fixed to the interior layer (Fig. 8S shows the fixation of each of the layers in place between exterior layers 890A and B), the exterior layer at least partially defining one or more channels (channel 838A);
an air inlet 1844 in fluid communication with the interior volume (Fig. 18D shows vent hole in fluid communication with fluid collection 1812 which is in fluid communication with interior volume of 800)
an outlet (portion of seam surrounding 830 to form outlet) in fluid communication with the interior volume (¶0135 outlet for egressing urine from the internal cavity), the outlet being formed within the receptacle and configured to enable extraction of fluid from the receptacle (¶0136 tube 879 extends through a seam 899 at the distal end of the collection member 812 and therefore formed within the receptacle; ¶0135 outlet for egressing urine from the internal cavity);
an exterior fluid permeable layer 890D positioned between at least a portion of the exterior-facing surface of the interior layer and at least a portion of the exterior layer (Fig. 8A exterior fluid permeable layer can be seen to be positioned between 890A and 890E); the exterior fluid permeable layer spaced from the interior volume by the interior layer (spaced from chamber 838B by interior layer); and
an interior fluid permeable layer (890C; ¶0130 includes a plurality of perforations 892 through which the first chamber communicates with the second chamber) positioned within the interior volume (positioned in the interior volume to separate internal volume into first and second chambers ¶0130 inner wall 890C separates the first chamber from the second chamber), the interior fluid permeable layer covering only a portion of the interior-facing surface (does not cover portion of interior-facing surface at locations of perforations 892); wherein the channel is configured to direct fluids received into the interior volume towards the outlet (channel 838A receives urine that is then directed by impermeable wall 890A to further layers 890D,E,C to 894 and out through outlet 830); and
a suction device coupled to the outlet (¶0139 vacuum pressure applied by a vacuum device at the outlet); and
wherein the channel is configured to direct fluids received into the interior volume towards the outlet (channel 838A receives urine that is then directed by impermeable wall 890A to further layers 890D,E,C to 894 and out through outlet 830).
Kharkar does not expressly disclose the air inlet being at least partially defined by the receptacle.
However, Sharma in the same field of endeavor of urine collection devices, teaches providing an air inlet 30 in fluid communication with an internal volume (¶0127 internal compartment, the second wall or first wall may have air ports to allow ambient air to be drawn into the pouch) that is defined by (¶0127) a receptacle 2 for the purpose of allowing ambient air to be drawn into the pouch to facilitated air flow through the pouch for the purpose of drawing urine away from the tip of the penis and in the direction of a fluid inlet 15 of an outlet tubing 14 (¶0122 the air flow thus generated additional serves to draw urine away from the tip of the penis and in the direction of the fluid inlets. Maintaining the suction and consequent air flow results in urine within the pouch being quickly drawn out and resultant dehumidification/drying of the pouch).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the receptacle of Kharkar to have included an air inlet in fluid communication with the internal volume that is defined by the receptacle as taught by Sharma for the purpose of allowing ambient air to be drawn into the pouch to facilitated air flow through the pouch for the purpose of drawing urine away from the tip of the penis and in the direction of a fluid inlet 15 of an outlet tubing 14 (¶0122 the air flow thus generated additional serves to draw urine away from the tip of the penis and in the direction of the fluid inlets. Maintaining the suction and consequent air flow results in urine within the pouch being quickly drawn out and resultant dehumidification/drying of the pouch).
Regarding claim 13, Kharkar in view of Sharma suggest the urine collection device of claim 12. Kharkar further discloses a tube 879 having a first end disposed within an aperture (aperture in seem 899) formed by the outlet (formed by outlet and seam) and a second end (878A) coupled to the suction device (¶0137 couple the port with the drain tube, thus configured to receive and retain drain tube; ¶0114 links drain tube to vacuum device).
Regarding claim 16, Kharkar in view of Sharma suggest the urine collection device of claim 12. Kharkar further discloses Kharkar further discloses wherein: the interior layer defines one or more apertures through which urine can exit the interior volume (¶0134 made from a mechanically absorbent polyester mesh material, mesh discloses multiple apertures that allow for fluid flow through the material); and the collection member being suitable to direct urine from the first chamber to the second chamber and direct the urine in the second chamber distally toward the outlet, but does not expressly disclose whether the outer layers 890A and 890B are fluid impermeable.
However, Sharma, in the same field of endeavor of urine collection devices, discloses making the front and back layers of the device out of liquid impermeable material (¶0152 liquid impermeable) and sealing them together for the purpose of configuring the device to be liquid impermeable and essentially enclosed to provide a receiving area to receive urine and at least temporarily hold urine within the enclosed space (¶0152).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of 890A and 890B that performs the function of directing urine through the chambers of the devices to an outlet for the fluid impermeable material of Sharma since these elements perform the same function of providing a suitable material to direct fluid such that fluid does not leak from the material. Simply substituting one fluid directing material means for another would yield the predictable result of allowing a(n) urine collection assembly to collect urine through a directed fluid pathway without leaking out of the collection assembly. See MPEP 2143.
Regarding claim 17, Kharkar in view of Sharma suggest the urine collection device of claim 16. Kharkar further discloses wherein the interior fluid permeable layer overlaying the one or more apertures (interior fluid permeable layer overlays the interior layer and would thus overlay the fluid pathway apertures).
Regarding claim 18, Kharkar discloses a method for transporting urine away from a body (¶0139 urine initially received in first chamber…urine can flow distally and egress from the collection chamber at the outlet) from a body, the method comprising:
positioning a receptacle 812 of a urine collection device 800 to abut a region surrounding a penis of a user and to position the penis in an interior volume (¶0131 penis is inserted by a user through the opening, the penis contacts the permeable layer), the receptacle including an interior layer 890E and an exterior layer 890A fixed to the interior layer (Fig. 8S shows the fixation of each of the layers in place between exterior layers 890A and B), and wherein:
an interior layer 890E including an interior-facing surface (surface facing away from layer 890A) and an exterior-facing surface (surface facing toward layer 890A) opposite the interior-facing surface, the interior-facing surface of the interior layer at least partially defining an interior volume (interior volume consists of space between layers 890A and 890B comprising chambers 838A and 838B; interior layer 890E defines the portion of the interior volume that it occupies), the exterior layer at least partially defining one or more channels (chamber 838A);
an exterior fluid permeable layer 890D positioned between at least a portion of the exterior-facing surface of the interior layer and at least a portion of the exterior layer (Fig. 8A exterior fluid permeable layer can be seen to be positioned between 890A and 890E); the exterior fluid permeable layer spaced from the interior volume by the interior layer (spaced from chamber 838B by interior layer); and
an interior fluid permeable layer (890C; ¶0130 includes a plurality of perforations 892 through which the first chamber communicates with the second chamber) positioned within the interior volume (positioned in the interior volume to separate internal volume into first and second chambers ¶0130 inner wall 890C separates the first chamber from the second chamber), the interior fluid permeable layer covering only a portion of the interior-facing surface (does not cover portion of interior-facing surface at locations of perforations 892);
receiving urine within the receptacle of the urine collection device (¶0139 urine initially received in the first chamber of the internal cavity);
directing the urine into the interior fluid permeable layer, through one or more apertures formed within an interior layer of the receptacle (¶0139 urine pass through the permeable layer 890D to the wicking layer 890E, which can provide capillary action to move the urine from the permeable layer to the inner wall), into the exterior fluid permeable layer (¶0139 urine pass through the permeable layer 890D into the wicking layer), into the one or more channels (¶0139 urine initially received in the first chamber), and to an outlet within the receptacle of the urine collection device (¶0139 the urine pass through the perforations in the inner wall to the second chamber. In the second chamber the urine can flow distally and egress from the collection member), the outlet at or near a first end (end opposite element 824 on same side as element 830) of the interior layer; and
removing the urine from the receptacle through the outlet (¶0139 the urine can flow distally and egress from the collection member at the outlet).
Kharkar does not expressly disclose receiving air within the receptacle through a valve of the receptacle; or the directing of the urine being responsive to receiving the air within the receptacle.
However, Sharma, in the same field of endeavor of urine collection devices, teaches receiving air 160 within a receptacle 2 of a urine collection device 1 through a valve 45b of the receptacle, and responsive to receiving the air within the receptacle directing the urine through the receptacle to an outlet of the device (¶0190 this flow conduit arrangement tends to pull the urine away from the penis which resides in the pouch toward the proximal end of the device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the receptacle of Kharkar to have included an air inlet in fluid communication with the internal volume such that air is received within the receptacle through a valve in the air inlet thus directing the urine in response to receiving the air within the receptacle as taught by Sharma for the purpose of allowing ambient air to be drawn into the pouch to facilitated air flow through the pouch for the purpose of drawing urine away from the tip of the penis and in the direction of a fluid inlet 15 of an outlet tubing 14 (¶0122 the air flow thus generated additional serves to draw urine away from the tip of the penis and in the direction of the fluid inlets. Maintaining the suction and consequent air flow results in urine within the pouch being quickly drawn out and resultant dehumidification/drying of the pouch).
Regarding claim 19, Kharkar in view of Sharma suggest the urine collection device of claim 18.
Kharkar further discloses a suction device generating a negative pressure within an interior volume of the receptacle using a suction device (¶0139 this flow of the urine through the collection member can be assisted by… a vacuum pressure applied by a vacuum at the outlet). Sharma further suggests the receiving air within the receptacle through the valve being responsive to generating a negative pressure within an interior volume of the receptacle using a suction device (¶0191 result of applied pressure differential by suction source).
The modification of the device of Kharkar to have included the air inlet and valve as taught by Sharma in the above rejection of claim 18 would have resulted in the receiving air within the receptacle through the valve being responsive to generating a negative pressure within an interior volume of the receptacle using a suction device (¶0191 of Sharma result of applied pressure differential by suction source).
Regarding claim 20, Kharkar in view of Sharma suggest the urine collection device of claim 18. Kharkar in view of Sharma does not expressly disclose or suggest the positioning the receptacle to abut the region surrounding the penis of the user including disposing a hydrogel on a rim of the receptacle, the hydrogel interfacing with the region.
However, Sharma, in the same field of endeavor of urine collection devices, further teaches positioning the receptacle to abut the region surrounding the penis of the user includes disposing a hydrogel on a rim of the receptacle, the hydrogel interfacing with the region (¶0223 adhesive layer for attachment to body in the areas surrounding the penis, hydrogels) for the purpose of providing a suitable attachment to the body in the areas surrounding the penis through an adhesive layer that is amenable to adhesion and removal from the skin even with hairs emanating from the skin, while being flexible enough to move with the skin without peeling off (¶0223).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the positioning of the receptacle to abut the region surrounding the penis of the user disclosed by Kharkar, to have included disposing a hydrogel on a rim of the receptacle, the hydrogel interfacing with the region, as taught by Sharma, for the purpose of providing a suitable attachment to the body in the areas surrounding the penis through an adhesive layer that is amenable to adhesion and removal from the skin even with hairs emanating from the skin, while being flexible enough to move with the skin without peeling off (¶0223 of Sharma).
Regarding claim 22, Kharkar in view of Sharma suggest the urine collection device of claim 1. Kharkar further discloses a recess defined by the one or more channels (channels form hollow space that recesses from the opening 824 toward the outlet). Kharkar does not expressly disclose the exterior fluid permeable layer including one or more protruding portions configured to at least partially occupy the recess.
However, Sharma, in the same field of endeavor of urine collection devices, teaches corrugating a layer 108 within a fluid collection device such that the layer has protruding portions (peaks and valleys protrude in opposite direction) configured to partially occupy a recess defined by one or more channels (interior volume formed by 94 and 96 constitutes channel that recesses from the inlet 3 to the outlet 12 and 15, protruding portion is contained within this space and thus partially occupies some of this space) for the purpose of maintaining space between the pouch walls to prevent vacuum locking (¶0169).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the exterior fluid permeable layer to have been corrugated and thus had protruding portion that partially occupied the recess, as taught by Sharma, for the purpose of maintaining space between the pouch walls to prevent vacuum locking (¶0169 of Sharma).
Regarding claim 23, Kharkar in view of Sharma suggest the urine collection device of claim 3. Kharkar further discloses the one or more apertures being formed proximal to the outlet and the one or more channels (¶0134 made from a mechanically absorbent polyester mesh material, mesh discloses multiple apertures that allow for fluid flow through the material, layer has end located proximal to the outlet and a surface proximal to the channel, being that the mesh forms the entire layer the entire layer has apertures and thus some apertures of the mesh would be proximal to the channel and the outlet)
Regarding claim 26, Kharkar in view of Sharma suggest the urine collection device of claim 4. Kharkar further discloses the one or more channels protruding outwardly from an exterior layer (Fig. 18A shows the end of the interior volume extending outwardly from the device to outlet 1808).
Regarding claim 27, Kharkar in view of Sharma suggest the urine collection device of claim 4. Kharkar further discloses a majority of the exterior facing surface of the interior layer and a majority of an interior facing surface of the exterior layer define an internal volume therebetween (portion of chamber 838A between exterior-facing surface of the interior layer and the interior-facing surface of the exterior layer), and a recess defined by the channel extending outwardly from the internal volume (chamber 838B recessed below interior layer and extends outwardly toward layer 890B from internal volume defined by the exterior facing surface of the interior layer and the interior facing surface of the exterior layer).
Regarding claim 30, Kharkar in view of Sharma suggest the urine collection device of claim 1. Kharkar further discloses wherein: the interior layer includes a first end and a second end opposite the first end (see illustrative diagram of Fig. 8A below), the first end and the second end adjacent to the exterior layer (ends adjacent 890A), the first end at or near the outlet (see illustrative diagram of Fig. 8A below), and the interior fluid permeable layer extending from the first end to an intermediate region (see illustrative diagram of Fig. 8A below) of the interior layer (interior fluid permeable layer extends the full longitudinal length of the interior layer and therefore extends from the first end to an intermediate region and past to the second end), the intermediate region spaced from the first end and the second end (intermediate region is inherently intermediate to first and second end).
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Illustrative diagram of Fig. 8A of Kharkar.
While Kharkar in view of Sharma as modified in claim 1 do not expressly suggest the second end at or near the air inlet, the second end of the interior layer is located at the end to which a user inserts their penis as depicted in the illustrative diagram above and Sharma further suggests the placement of the air inlet being at a proximal end at which the penis is inserted for the purpose of allowing the air flow to pass by the penis (¶0189).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have positioned the air inlets suggested by Kharkar in view of Sharma to have been at the end at which the penis is inserted, as taught by Sharma, for the purpose of allowing the air flow to pass by the penis (¶0189 of Sharma).
Placement of the air inlets in this positioning would have resulting in the second end of the interior layer being located near the air inlets.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kharkar et al. (U.S. Publication 2022/0265461) in view of Sharma et al. (U.S. Publication 2021/0353449) and Terauchi (U.S. Patent No. 4,281,655) and further in view of Keane (U.S. Patent No. 3,349,768).
Regarding claim 14, Kharkar in view of Sharma suggest the system of claim 12. Kharkar in view of Sharma do not expressly disclose or suggest an air supply coupled to the air inlet, the air supply being coupled to the air inlet by a tube having a first end disposed within an aperture formed by the air inlet and a second end coupled to the air supply.
However, Terauchi, in the same field of endeavor of urine collection devices discloses an air supply (Col. 2 lines 10-17 exhaust of suction pump) coupled to an air inlet 5, the air supply being coupled to the air inlet by a tube 4 having a first end (end seen in Fig. 1 connected to 5) connected to an aperture formed by the air inlet (tube connected to aperture that creates flow path through element 5) and a second end coupled to the air supply (Col. 2 lines 10-17 exhausted air from the suction pump is to be supplied through vinyl tube 4) for the purpose of providing air circulation even when the outer surface of the urine receiving unit is covered with diapers and vinyl cover which would normally close the air flow holes (Col. 2 lines 10-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the air inlet of Kharkar in view of Sharma to have been coupled to a tube coupled to an air supply as taught by Terauchi for the purpose of providing air circulation even when the outer surface of the urine receiving unit is covered with diapers and vinyl cover which would normally close the air flow holes (Col. 2 lines 10-17).
Kharkar in view of Sharma and Terauchi fail to suggest the tube first end being disposed within an aperture formed by the air inlet, however, Keane, in the same field of endeavor of urine collection devices, discloses a tube 33 having a first end disposed within an aperture formed by an air inlet 32 for the purpose of connecting the tubing to the aperture (Col. 3 lines 67-74 socket being connected to breather pipe).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the tube connector suggested by Terauchi that performs the function of connecting a tube to an air inlet for the tube connector of Keane since these elements perform the same function of connecting an air supply tube to an air inlet. Simply substituting one tube connecting means for another would yield the predictable result of allowing a(n) an air supply tube to be connected to an air inlet. See MPEP 2143.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kharkar et al. (U.S. Publication 2022/0265461) in view of Sharma et al. (U.S. Publication 2021/0353449) and Ecklund et al. (U.S. Publication 2019/0247222).
Regarding claim 21, Kharkar in view of Sharma suggest the urine collection device of claim 3. Kharkar further discloses a plurality of apertures (mesh inherently has pores). Kharkar does not expressly disclose one or more of the plurality of apertures positioned nearest at least one of the outlet or the one or more channels exhibiting a diameter that is greater than one or more of the plurality of apertures furthest from the at least one of the outlet or the one or more channels.
However, Ecklund, in the same field of endeavor of urine collection devices, teaches an aperture 995 located proximal to the outlet 930 that is larger than other apertures 992 for the purpose of helping to receive and/or maintain the urine in the second chamber in areas proximal to outlet (¶0138).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apertures of Keane to have provided an aperture with greater diameter that was located proximal to the outlet, as taught by Ecklund for the purpose of helping to receive and/or maintain the urine in the channel 31 in areas proximal to the outlet (¶0138 of Ecklund).
Allowable Subject Matter
Claims 28-29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 28, Kharkar in view of Sharma suggest the urine collection device of claim 3. Neither Kharkar nor Sharma expressly disclose or suggest the one or more apertures being only formed in the first end and, optionally, the intermediate region of the interior layer. The apertures discloses by Kharkar are a result of the interior layer being formed of a mesh and the interior layer of Kharkar functions to wick fluid that enters the first chamber toward the second chamber of the device. It would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified this layer for the apertures to only be formed in the first end and optionally the intermediate region of this layer as there is no suggestion or motivation found in the art to perform such a modification. As such this subject matter would be considered allowable if rewritten in independent form including all the limitations of the base claim.
Regarding claim 29, Kharkar in view of Sharma suggest the urine collection device of claim 1. Kharkar further disclose the interior layer including a first end and a second end opposite the first end, the first end and the second end adjacent to the exterior layer, the first end near the outlet.
While the limitation of the second end being near the air inlet is seen to have been obvious as detailed in the above rejection of claim 30, neither Kharkar nor Sharma suggest the exterior fluid permeable layer covering only a portion of the exterior-facing surface, wherein the portion of the exterior-facing surface covered by the exterior fluid permeable layer extends from the first end to an intermediate region of the interior layer, the intermediate region spaced from the first end and the second end, and modifying the device of Kharkar in view of Sharma as suggested above in relation to the rejection of claim 1, to have included this structure of the exterior fluid permeable layer would not have been obvious to one of ordinary skill in the art before the effective filing date as there is no suggestion or motivation found in the art to perform such a modification. As such this subject matter would be considered allowable if rewritten in independent form including all the limitations of the base claim.
Conclusion
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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