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 .
Claim Status
The amendment submitted on September 18th, 2025 has been entered. Claims 1, 3-5, 7-14, and 16-27 are currently pending. Claims 23-27 have been newly added. Claim 6 has been newly cancelled. Claims 1, 4-5, 9, 12, 17-18, and 21-22 have been amended. Claims 2 and 15 remain cancelled.
Response to Arguments
Applicant's arguments filed September 18th, 2025 have been fully considered but they are not persuasive.
Regarding applicant’s arguments pertaining to claim 1, applicant’s arguments are drawn to the amended claim language further limiting the claim to state that the fluid permeable layer is disposed adjacent an exterior facing surface of the interior layer and the exterior layer. While examiner agrees that the additional claim limitations have overcome the prior rejection, in light of the teachings of Lawrence et al. (U.S. Patent No. 5,911,222) these limitations are seen to be taught by the new reference when combined with the disclosure of Keane.
Regarding applicant’s arguments pertaining to claim 12, applicant’s arguments are drawn to the amended claim language further limiting the claim to state that the fluid permeable layer is disposed adjacent an exterior facing surface of the interior layer and the exterior layer. While examiner agrees that the additional claim limitations have overcome the prior rejection, in light of the teachings of Lawrence et al. (U.S. Patent No. 5,911,222) these limitations are seen to be taught by the new reference when combined with the disclosure of Keane (see rejection below).
Regarding applicant’s arguments pertaining to claim 18 apertures, applicant argues that Sharma does not teach the one or more apertures as defined by the claim. Examiner disagrees in that the channels formed by layer 109 would necessarily form apertures at each end of the channel in order to allow for the passage of urine when vacuum is applied and as such Sharma teaches this limitation.
Regarding applicant’s arguments pertaining to rejection of claim 18 with Sharma in regard to the fluid permeable layer, the amended claim limitations have overcome the prior rejection, however, in light of the teachings of Lawrence et al. (U.S. Patent No. 5,911,222) these limitations are seen to be taught by the new reference when combined with the disclosure of Sharma (see rejection below).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 27 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 recites the limitation "the one or more recesses extending outwardly from the internal volume" in lines 3 and 4 and “the exterior-facing surface of the interior region”. There is insufficient antecedent basis for these limitation in the claim. “The one or more recesses extending outwardly from the internal volume” has not been described previously and as such is indefinite as it is unclear what recess described extends outwardly from the internal volume. For the purpose of examination this limitation is being interpreted to mean that a recess is defined by the one or more channels introduced in claim 26 that protrude outwardly from an exterior surface of the exterior layer and also form a recess within the interior cavity that extends outwardly through the outward extension of the exterior surface. “The exterior facing-surface of the interior region” is being interpreted to mean the exterior-facing surface of the interior layer described 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, 4, 6-9, 12-14, 16, 17, 22, 23, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Keane (U.S. Patent No. 3,349,768) in view of Lawrence et al. (U.S. Patent No. 5,911,222).
Regarding claim 1, Keane discloses a urine collection device (Fig. 10), comprising:
a receptacle 1” including:
an interior layer 35 including an interior-facing surface facing toward element 11’ and an exterior-facing surface (surface facing 31) opposite the interior-facing surface, the interior-facing surface of the interior layer at least partially defining an interior volume (forms interior volume in which 11’ sits); and
an exterior layer 36 fixed to the interior layer (interior layer inserted into 36), the exterior layer at least partially defining one or more channels 3’;
an air inlet 32 in fluid communication with the interior volume (open to 31), the air inlet being at least partially defined by the receptacle (defined by wall 36); and
an outlet 3a’ in fluid communication with the interior volume (Col. 3 lines 61-66, 30 has inlet 2’ leads to cavity 3’ in communication with outlet 3a’), the outlet being formed within the receptacle (formed in 1”) and configured to enable extraction of fluid from the receptacle (subject to vacuum); and
a fluid permeable layer 11’ positioned between a portion of the interior layer and a portion of the exterior layer (disposed between the upper rim of exterior layer 36 and element 35);
wherein the one or more channels are configured to direct fluids received into the interior volume towards the outlet (Channel 3’ directs fluids from inlet 2’ to outlet 3a’).
Keane does not expressly disclose the interior volume being configured to receive a penis of a user; or a fluid permeable layer positioned between at least a portion of the exterior-facing surface of the interior layer and at least a portion of the exterior layer.
Regarding the interior volume being configured to receive a penis, while Keane does not expressly disclose this embodiment being capable of receiving a penis, the limitation of “configured to receive a penis of a user” is considered functional language (describes the positioning of the device such that a user’s penis is presented to, i.e. received by, the interior volume). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Keane discloses the structure of the interior volume and is placed such that a user’s genitalia is placed in contact with the interior volume as to receive excreted urine. As such, it is capable of performing the functions as claimed (i.e. it is capable of being placed in contact with a penis). While the examiner notes that the interior volume of Fig. 10 has foam layer 11 occupying the interior volume, this foam layer is not seen to prevent one from placing the device such that the foam layer comes in contact with the tip of the penis and thus receiving it into the interior volume. Furthermore, the ability of the device to receive a penis is only limited by the size of the penis that is intended to be received and as such this function of “configured to receive a penis of a user” is dependent upon the size of the user’s penis which is not defined by the claim. A “micropenis” for example would be capable of being retained in a smaller comparative space to a larger penis.
Furthermore, Keane further teaches in the embodiments of Figs. 6-8 and the description of claim 3, shaping the sheath 12 of a device to accommodate a penis. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to have modified the embodiment of Fig. 10 to have been configured to receive a penis of a user in instances where the penis would not fit in the interior volume of the embodiment of Fig. 10 when the embodiment Fig. 10 is viewed in light of the teachings of the embodiment taught in Figs. 6-8 of Keane which shapes the walls of the device to accommodate a penis since Keane teaches the technique of shaping a device such that a penis can be accommodated and it has been held that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. This known technique of shaping the outer wall and thus the interior volume and components including in the interior volume to accommodate a penis would have yielded predictable results of allowing a penis to be inserted into the interior volume and thus received.
Regarding a fluid permeable layer positioned between at least a portion of the exterior-facing surface of the interior layer and at least a portion of the exterior layer, Lawrence, in the same field of endeavor of urine collection devices (Col 1 lines 12 improved urine removal), teaches a receptacle (Fig. 2b) including an interior layer 25 including an interior facing surface (surface facing layer 24) and an exterior-facing surface (surface facing 27) opposite the interior-facing surface, the interior-facing surface of the interior layer at least partially defining an interior volume (defines internal volume in which 24 sits); an exterior layer 28, and a fluid permeable (open celled foam) layer 27 positioned between at least a portion of the exterior-facing surface of the interior layer and at least a portion of the exterior layer for the purpose of providing (positioned adjacent to exterior facing surface of 25 such that it is between 25 and the bottom of 28, see Fig. 2b) for the purpose of providing structure to the device and preventing collapse due to vacuum.
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 device of Keane to have provided a fluid permeable layer on the exterior facing side of the interior layer, as taught by Lawrence, for the purpose of preventing collapse of channel 31 during application of vacuum to the device.
Regarding claim 3, Keane in view of Lawrence suggests the urine collection device of claim 1. Keane further discloses the interior layer defining one or more apertures (mesh inherently has pores, fluid intended to flow into device and through 35 into channel 31 indicating apertures for fluid flow) through which urine can exit the interior volume; and the exterior layer is fluid impermeable (Col. 1 lines 66-72, made of semi-rigid rubber, thermoplastic material, and not disclosed to be open-cell or porous and therefore would be fluid impermeable, functional claim language discussed below).
While Keane does not expressly disclose the exterior layer being “fluid impermeable”, the limitation of “fluid impermeable” is considered functional language (describes the function of the material to resist permeation by fluids and retain the fluids within the device). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Keane discloses all the structure as claimed, and is further used to direct bodily fluids excreted by a patient through the interior of the device to an outlet. Keane further describes other materials as being permeable to fluids through porosity, but does not describe the exterior layer as being porous and therefore would be a non-porous thermoplastic or rubber which would inherently be fluid impermeable based on the inherent fluid impermeability of rubber and thermoplastic materials without included pores. As such, it is capable of performing the functions as claimed (i.e. it is capable of not being permeable to fluids).
Regarding claim 4, Keane in view of Lawrence suggests the urine collection device of claim 3. Keane further discloses a fluid permeable layer 11’ positioned within the interior volume (positioned above 35 within 30), the fluid permeable layer overlaying the one or more apertures (overlays element 35 and thus overlays apertures in mesh).
Regarding claim 6, Keane in view of Lawrence suggests the urine collection device of claim 1. Keane further discloses a fluid permeable layer disposed between at least a portion of the interior and exterior layers (disposed between the upper rim of exterior layer 36 and element 35).
Regarding claim 7, Keane in view of Lawrence suggests the urine collection device of claim 1. Keane further discloses the outlet being in fluid communication with a suction device (Col. 4 lines 68-72 piped vacuum supply).
Regarding claim 8, Keane in view of Lawrence suggests the urine collection device of claim 7. Keane further discloses the outlet is configured to receive and retain a tube of the suction device (Fig. 4 shows tubing 4 being received onto element 3a and retained thereon).
Regarding claim 9, Keane in view of Lawrence suggests the urine collection device of claim 1. Keane further discloses the receptacle forms a rim surrounding a periphery of the receptacle, the rim having a shape that interfaces with a region surrounding the penis of a user (rim upper portion of element 36 that interacts with patient).
Regarding claim 12, Keane discloses a system for transporting urine away from a penis of a user (Fig. 10, Col. 4 lines 2-3, makes direct contact with the external genitalia) , the system comprising:
a urine collection device (Fig. 10) comprising: a receptacle 1” defining an interior volume 30 and configured to receive a penis of a user (Col. 4 lines 2-3, makes direct contact with the external genitalia),
the receptacle including an interior layer 35 and an exterior layer 36 fixed to the interior layer (interior layer inserted into 36), the exterior layer at least partially defining one or more channels 3’;
an air inlet 32 in fluid communication with the interior volume (open to 31), the air inlet being at least partially defined by the receptacle (defined by wall 36); and an outlet 3a’ in fluid communication with the interior volume (Col. 3 lines 61-66, 30 has inlet 2’ leads to cavity 3’ in communication with outlet 3a’), the outlet being formed within the receptacle (formed in 1”) and configured to enable extraction of fluid from the receptacle (subject to vacuum); and a suction device (Col. 4 lines 68-72 piped vacuum supply) coupled to the outlet (coupled to tubing 4) wherein the one or more channels are configured to direct fluids received into the interior volume towards the outlet (directs fluids from inlet 2’ to outlet 3a’).
Keane does not expressly disclose the interior volume being configured to receive a penis of a user; or a fluid permeable layer positioned between at least a portion of the exterior-facing surface of the interior layer and at least a portion of the exterior layer.
Regarding the interior volume being configured to receive a penis, while Keane does not expressly disclose this embodiment being capable of receiving a penis, the limitation of “configured to receive a penis of a user” is considered functional language (describes the positioning of the device such that a user’s penis is presented to, i.e. received by, the interior volume). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Keane discloses the structure of the interior volume and is placed such that a user’s genitalia is placed in contact with the interior volume as to receive excreted urine. As such, it is capable of performing the functions as claimed (i.e. it is capable of being placed in contact with a penis). While the examiner notes that the interior volume of Fig. 10 has foam layer 11 occupying the interior volume, this foam layer is not seen to prevent one from placing the device such that the foam layer comes in contact with the tip of the penis and thus receiving it into the interior volume. Furthermore, the ability of the device to receive a penis is only limited by the size of the penis that is intended to be received and as such this function of “configured to receive a penis of a user” is dependent upon the size of the user’s penis which is not defined by the claim. A “micropenis” for example would be capable of being retained in a smaller comparative space to a larger penis.
Furthermore, Keane further teaches in the embodiments of Figs. 6-8 and the description of claim 3, shaping the sheath 12 of a device to accommodate a penis. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to have modified the embodiment of Fig. 10 to have been configured to receive a penis of a user in instances where the penis would not fit in the interior volume of the embodiment of Fig. 10 when the embodiment Fig. 10 is viewed in light of the teachings of the embodiment taught in Figs. 6-8 of Keane which shapes the walls of the device to accommodate a penis since Keane teaches the technique of shaping a device such that a penis can be accommodated and it has been held that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. This known technique of shaping the outer wall and thus the interior volume and components including in the interior volume to accommodate a penis would have yielded predictable results of allowing a penis to be inserted into the interior volume and thus received.
Regarding a fluid permeable layer positioned between at least a portion of the exterior-facing surface of the interior layer and at least a portion of the exterior layer, Lawrence, in the same field of endeavor of urine collection devices (Col 1 lines 12 improved urine removal), teaches a receptacle (Fig. 2b) including an interior layer 25 including an interior facing surface (surface facing layer 24) and an exterior-facing surface (surface facing 27) opposite the interior-facing surface, the interior-facing surface of the interior layer at least partially defining an interior volume (defines internal volume in which 24 sits); an exterior layer 28, and a fluid permeable (open celled foam) layer 27 positioned between at least a portion of the exterior-facing surface of the interior layer and at least a portion of the exterior layer for the purpose of providing (positioned adjacent to exterior facing surface of 25 such that it is between 25 and the bottom of 28, see Fig. 2b) for the purpose of providing structure to the device and preventing collapse due to vacuum.
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 device of Keane to have provided a fluid permeable layer on the exterior facing side of the interior layer, as taught by Lawrence, for the purpose of preventing collapse of channel 31 during application of vacuum to the device.
Regarding claim 13, Keane in view of Lawrence suggests the system of claim 12. Keane discloses a tube 4’ having a first end coupled to aperture 3a’ (see Fig. 9) and a second end coupled to the suction device (Col. 3 lines 60-65 connection to a urine container subjected to a gentle partial vacuum), in the embodiment disclosed above in the rejection of claim 12, however, Keane does not expressly disclose the tube having the first end disposed within an aperture formed by the outlet.
However, Keane, in the same field of endeavor of urinary suction devices, in the embodiment shown in Figs. 1 and 2, teaches a tube 5 with a first end (end reaching toward chamber 3) disposed within an aperture formed by an outlet 3a (disposed within the cavity formed by element 3a) and a second end (end of element 5 protruding from 3a as seen in Fig. 1) coupled to the suction device (coupled through attachment of tubing 4 which is coupled to suction device) for the purpose of providing direct application of vacuum to the cavity where urine accumulates in order to discharge any urine accumulating there quickly (Col. 2 lines 18-33) and furthermore teaches tubing 4’ being connected to the suction head at the front or rear thereof to communicated directly with the inlet to channel 31 (Col. 4 lines 52-60).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a tube within the aperture of the embodiment of Keane seen in Fig. 10, as taught by the embodiment of Keane presented in Fig. 1 and 2 for the purpose of providing direct application of vacuum to the cavity where urine accumulates in order to discharge any urine accumulating there quickly (Col. 2 lines 18-33), and furthermore as Keane discloses connecting tubing 4’ to the front or rear thereof, it would have been obvious to have the tubing within the aperture formed by 3a’ in order to place tubing at the front to communicate directly with the inlet to channel 31 as suggested in Col. 4 lines 52-60.
Regarding claim 14, Keane in view of Lawrence suggests the system of claim 12. Keane further discloses an air supply (atmosphere) coupled to the air inlet (Col. 67-74 breather pipe open to atmosphere at its free end), the air supply being coupled to the air inlet by a tube (33) having a first end disposed within an aperture formed by the air inlet (Fig 10 shows one end of 33 disposed within the aperture formed by 32) and a second end coupled to the air supply (Col. 67-74 breather pipe open to atmosphere at its free end).
Regarding claim 16, Keane in view of Lawrence suggests the system of claim 12. Keane further discloses the interior layer defines one or more apertures (mesh inherently has pores, fluid intended to flow into device and through 35 into channel 31 indicating apertures for fluid flow) through which urine can exit the interior volume; and the exterior layer is fluid impermeable (Col. 1 lines 66-72, made of semi-rigid rubber, thermoplastic material, and not disclosed to be open-cell or porous and therefore would be fluid impermeable, functional claim language discussed below).
While Keane does not expressly disclose the exterior layer being “fluid impermeable”, the limitation of “fluid impermeable” is considered functional language (describes the function of the material to resist permeation by fluids and retain the fluids within the device). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Keane discloses all the structure as claimed, and is further used to direct bodily fluids excreted by a patient through the interior of the device to an outlet. Keane further describes other materials as being permeable to fluids through porosity, but does not describe the exterior layer as being porous and therefore would be a non-porous thermoplastic or rubber which would inherently be fluid impermeable based on the inherent fluid impermeability of rubber and thermoplastic materials without included pores. As such, it is capable of performing the functions as claimed (i.e. it is capable of not being permeable to fluids).
Regarding claim 17, Keane in view of Lawrence suggests the system of claim 16. Keane further discloses a fluid permeable layer 11’ positioned within the interior volume (positioned above 35 within 30), the fluid permeable layer overlaying the one or more apertures (overlays element 35 and thus overlays apertures in mesh).
Regarding claim 22, Keane in view of Lawrence suggests the urine collection device of claim 1. Keane in view of Lawrence further suggest the fluid permeable layer includes one or more protruding portions configured to at least partially occupy a recess 2’ defined by the one or more channels as Keane in view of Lawrence suggests the fluid permeable layer being placed beneath layer 35 such that it is between a suction inlet into an internal volume and the layer 35, as such a portion of the layer would protrude over the inlet recess 2’ and thus occupy the portion of the channel space at 2’.
Regarding claim 23, Keane in view of Lawrence suggests the urine collection device of claim 3. Keane further discloses the one or more apertures being formed proximal to the outlet and the one or more channels (apertures formed through the layer such that they would have an end proximal to the channel and outlet).
Regarding claim 26, Keane in view of Lawrence suggests the urine collection device of claim 4. Keane further discloses the one or more channels protruding outwardly from an exterior surface of the exterior layer (see illustrative diagram of Fig. 10 below).
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Illustrative diagram of Fig. 10 of Keane.
Regarding claim 27, Keane in view of Lawrence suggests the urine collection device of claim 4. Keane further discloses the majority of the exterior-facing surface of the interior layer and a majority of an interior facing surface (surface facing internal volume) of the exterior layer defining an internal volume therebetween (define internal volume 31 between, majority of interior facing surface of exterior layer is located adjacent to 31 as the longitudinal portion of the interior facing surface of the exterior layer is positioned underneath 31 and the longitudinal portion is the majority of the interior facing surface), a recess 2’ defined by the channel 3’ extending outwardly from the internal volume (see above illustrative diagram of fig. 10 regarding extension outwardly).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keane (U.S. Patent No. 3,349,768) in view of Lawrence et al. (U.S. Patent No. 5,911,222) and Sanchez et al. (U.S. Publication 2016/0374848).
Regarding claim 5, Keane in view of Lawrence suggests the urine collection device of claim 4. Keane does not expressly disclose the fluid permeable layer being retained within the interior volume by an adhesive. However, Sanchez, in the same field of endeavor of urine collection devices discloses a fluid permeable layer 230 secured in place within an interior volume with securing elements 252 that include water-resistant adhesive tape for the purpose of securing the permeable layer in place within the device (¶0082).
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 fluid permeable layer disclosed by Keane to have been secured in place within the device by adhesive, as taught by Sanchez, for the purpose of preventing movement of the layer when being used by the patient and thus allowing the devices permeable layer to continually perform its function properly within the device with less risk of the permeable layer being displaced within the device during use (Sanchez ¶0082).
Claim(s) 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Keane (U.S. Patent No. 3,349,768) in view of Lawrence et al. (U.S. Patent No. 5,911,222) and Tokarz et al. (U.S. Patent No. 4,681,572).
Regarding claims 10 and 11, Keane in view of Lawrence suggests the urine collection device of claim 1. Keane does not expressly disclose the air inlet including a valve wherein the valve is an umbrella check valve.
However, Tokarz, in the same field of endeavor of urinary collection devices, discloses an air inlet 250 including an umbrella check valve 251 for the purpose of allowing entry of ambient air while at the same time blocking the escape of fluids (gases and liquids) from the receptacle of the device (Col. 8 lines 11-26).
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 Keane to have included an umbrella check valve as taught by Tokarz for the purpose of allowing entry of ambient air while at the same time blocking the escape of fluids (gases and liquids) from the receptacle of the device (Col. 8 lines 11-26).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (U.S. Publication 2021/0353449) in view of Lawrence et al. (U.S. Patent No. 5,911,222).
Regarding claim 18, Sharma discloses a method for transporting urine away from a body (¶0112 urine removal devices that are suction-assisted, and enable urine to be conveniently and hygienically removed from the region surrounding a male patient’s external genitalia area), the method comprising:
positioning a receptacle 102 of a urine collection device to abut a region surrounding a penis of a user (Fig. 2A shows the penis positioned through hole 3 thus having device abutting region surrounding penis),
the receptacle including an interior layer 108 and an exterior layer (104 and 106) fixed (¶0170 attached to first wall or second wall) to the interior layer,
the interior layer including an interior-facing surface and an exterior facing surface opposite the interior-facing surface, the interior-facing surface of the interior layer at least partially defining the interior volume,
the exterior layer at least partially defining one or more channels (corrugations 109 form channels between sheet 104 and 108 when bonded;
receiving urine within the receptacle of the urine collection device (Fig. 2A fluid in arrow);
receiving air within the receptacle (Fig. 14 air in arrow 160) through a valve 45b of the receptacle;
responsive to receiving the air within the receptacle, directing the urine through one or more apertures formed within an interior layer of the receptacle, into the one or more channels (channels 109 form apertures when vacuum is applied such that high points contact walls 106 and 104 with channels 109 providing apertures at distal and proximal ends for fluid to flow into and out of the channel), and to an outlet (17 or 13; ¶0127 fluid drawn from fluid inlet openings through the internal lumen and out of fluid outlet openings 17 and 13) within the receptacle of the urine collection device; and
removing the urine from the receptacle through the outlet (air enters pouch as a result of pressure differential applied by suction source and air draws urine vapor flow to inlets 15 and 12 to outlets 17 and 13 and out of bag at 173, ¶0127 and ¶0191 details air and urine vapor flow).
Sharma does not expressly disclose a fluid permeable layer positioned between at least a portion of the exterior-facing surface of the interior layer and at least a portion of the exterior layer.
Regarding a fluid permeable layer positioned between at least a portion of the exterior-facing surface of the interior layer and at least a portion of the exterior layer, Lawrence, in the same field of endeavor of urine collection devices (Col 1 lines 12 improved urine removal), teaches a receptacle (Fig. 2b) including an interior layer 25 including an interior facing surface (surface facing layer 24) and an exterior-facing surface (surface facing 27) opposite the interior-facing surface, the interior-facing surface of the interior layer at least partially defining an interior volume (defines internal volume in which 24 sits); an exterior layer 28, and a fluid permeable (open celled foam) layer 27 positioned between at least a portion of the exterior-facing surface of the interior layer and at least a portion of the exterior layer for the purpose of providing (positioned adjacent to exterior facing surface of 25 such that it is between 25 and the bottom of 28, see Fig. 2b) for the purpose of providing structure to the device and preventing collapse due to vacuum.
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 device of Sharma to have provided a fluid permeable layer on the exterior and interior facing sides of the interior layer, as taught by Lawrence, for the purpose of further preventing collapse of channel outer layers of Sharma into the corrugated channels during application of vacuum to the device.
Regarding claim 19, Sharma in view of Lawrence suggest the method of claim 18. Sharma further discloses receiving air within the receptacle through the valve is 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).
Regarding claim 20, Sharma in view of Lawrence suggest the method of claim 18. Sharma further discloses 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).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Keane (U.S. Patent No. 3,349,768) in view of Lawrence et al. (U.S. Patent No. 5,911,222) and Ecklund et al. (U.S. Publication 2019/0247222).
Regarding claim 21, Keane in view of Lawrence suggests the urine collection device of claim 3. Keane further discloses the one or more apertures including a plurality of apertures (mesh inherently has pores, fluid intended to flow into device and through 35 into channel 31 indicating apertures for fluid flow). Keane 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).
Claim(s) 24 and 25 is rejected under 35 U.S.C. 103 as being unpatentable over Keane (U.S. Patent No. 3,349,768) in view of Lawrence et al. (U.S. Patent No. 5,911,222) and further in view of Sharma (U.S. Publication 2021/0353449).
Regarding claims 24 and 25, Keane in view of Lawrence suggest the urine collection device of claims 1 and 4. Neither Keane nor Lawrence expressly disclose or suggest the exterior or interior facing surfaces of the interior layer including first and second regions respectively, with the fluid permeable layer and interior fluid permeable layers being disposed on the first regions and not disposed on the second regions, or the second region of the exterior facing surface of the interior layer being spaced from the exterior layer.
However, Sharma, in the same field of endeavor of urine collection devices, teaches an interior layer including exterior (surface facing 104) and interior (surface facing 106) facing surfaces with layers disposed on either side (104 and 106) including first (high point of corrugation) and second regions (low point of corrugation) wherein the layers adjacent to the exterior and interior facing sides interact only with the first region (high points of corrugation) with the second regions not being disposed on the layers and spaced from the adjacent layers (spaced apart in order to form channels (¶0172 channels 109) for the purpose of forming channels between the layers in order to prevent vacuum locking of the layers together (¶0169 maintaining space between walls and prevent vacuum locking).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the interior layer of Keane corrugated and thus spaced the layers apart from one another at the low points of the corrugation for the purpose of creating better flow of fluid through the layers during suction and preventing vacuum locking (¶0169 of Sharma).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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