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 Arguments
Applicant’s amendments submitted 09/17/2025 have been accepted and entered.
Applicant’s arguments with respect to claims 1 and 11 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.
Applicant argues that the cited references do not teach the amended limitations of claim 21. However, Okabe teaches that at least a majority of the fluid permeable membrane partially defines a substantially unoccupied space between the fluid permeable membrane and the porous body as set forth in the rejection below for claim 21.
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 1-22 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.
Claims 1, 11, and 21 use the term “substantially unoccupied space”. It is unclear what constitutes a substantially unoccupied space. Thus the examiner is interpreting this limitation as any empty space between the claimed elements defining the unoccupied space.
Claim 2-10, 12-20, and 22 rejected based on their dependency from claims 1 and 11.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-5, 7-12, 17, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Davis (US 20180228642 A1) in view of Machida (US 20050033248 A1), further in view of Suydam (US 20020193762 A1), further in view of Okabe (US 20040254547 A1), further in view of Newton (US 20180049910 A1).
Regarding Claim 1 and 22, Davis discloses a fluid collection device (urine collection device 10, Fig 7) configured to be positioned at least proximate a urethra of a female user (a device for collecting and removing urine that has been discharged from the body of a user, in particular a female user ¶[0051]), the fluid collection device (urine collection device 10, Fig 7) comprising:
a fluid impermeable enclosure (external covering 20 is fluid impermeable ¶[0052]),
a fluid permeable membrane (outer collection layer 40, Fig 7 is fluid permeable ¶[0057]);
a reservoir (cavity defined by external covering 20, Fig 1¶[0052]) at least partially defined by the fluid impermeable enclosure (20, Fig 7) and the fluid permeable membrane (40 defines part of the cavity at the fenestration 30, Fig 7), the reservoir (cavity defined by external covering 20, Fig 1¶[0052]) configured to receive fluid discharged from the user through the fluid permeable membrane (fluid flows from a urethral opening of a user’s body through fenestration 30, in which outer collection layer 40 is disposed, into a cavity defined by external covering 20, Fig 1 ¶[0052]);
a porous body (inner collection core 42 may be a polyester filter foam material that wicks fluid from the outer collection layer 40 into the cavity without retaining the fluid, and thus may be porous, Fig 7 ¶[0059]) disposed in the reservoir (cavity defined by external covering 20, Fig 1¶[0052]);
and a drain tube (32, Fig 7) in fluid communication with the reservoir (cavity ¶[0052]) and the porous body (42, Fig 7), the drain tube (32, Fig 7) positioned and configured to drain the fluid (fluid collection in device 10 is evacuated from device 10 through tube 32, Fig 7 ¶[0060]) that flows through the porous body (fluid must pass through 40 and 42 to be evacuated from 10 through 32, Fig 7).
The first embodiment of Davis is silent whether the fluid impermeable enclosure exhibits a planar hourglass-shaped outer contour, the fluid impermeable enclosure including an inner surface, the inner surface including a first portion and a second portion at least partially enclosed by the first portion, the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure; a raised boundary having a single continuous wall portion extending around a periphery of the fluid collection device that includes a single continuous convex contact surface positioned to contact the female user, and whether the drain tube is positioned at a gravimetrically low point in the fluid collection device, and whether a porous body includes an upper surface including discrete holes and a lower surface contacting the first portion of the inner surface of the fluid impermeable enclosure; wherein the second portion of the inner surface partially defines a substantially unoccupied space between the second portion and the porous body, the aperture adjacent to the substantially unoccupied space.
However, an separate embodiment of Davis teaches that the fluid impermeable enclosure exhibits a planar hourglass-shaped outer contour (an alternative shape of the external covering 20 wherein 20 has a planar hourglass-shaped outer contour, Fig 8 ¶[0055]) in order to provide a better contoured fit for the user’s pubic region, perineum, and coccyx (¶[0055]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid permeable enclosure of the first embodiment of Davis so that the fluid impermeable enclosure exhibits a planar hourglass-shaped outer contour, as taught by the embodiment of Davis in Figure 8, in order to provide a better contoured fit for the user’s pubic region, perineum, and coccyx (as motivated by Davis ¶[0055]).
Davis is silent regarding a cross-section having a raised boundary having a single continuous wall portion extending around a periphery of the fluid collection device that includes a single continuous convex contact surface positioned to contact the female user; whether the fluid impermeable enclosure includes an inner surface, the inner surface including a first portion and a second portion at least partially enclosed by the first portion, the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure; and whether the drain tube is positioned at a gravimetrically low point in the fluid collection device, and whether a porous body includes an upper surface including discrete holes and a lower surface contacting the first portion of the inner surface of the fluid impermeable enclosure, wherein the second portion of the inner surface completely defines an inlet of the aperture.
However, Machida teaches an automatic urine disposal device, thus from the same field of endeavor, with a raised boundary having a single continuous wall portion (outer sheet 5 and gathers 6, Fig 5) extending around a periphery of the fluid collection device (gathers 6 extends along the periphery of outer sheet 5, Fig 5) that is positioned to contact the female user (gathers 6 are disposed on the top side of the urine collecting pad 1 which contacts the user, Fig 5), and a drain tube (urine drainage tube 8, Fig 1) positioned at the gravimetrically low point in the fluid collection device (8 is positioned at the center-most low point of device 1 as shown in Fig 1), and a porous body with a lower surface contacting an inner surface of the fluid impermeable enclosure (Fig 5 ¶[0010][0021][0043] urine absorbent sheet 4 may be porous and has a lower surface contacting an inner surface of impermeable outer sheet 5) in order to keep the urine absorbent sheet sealed air tight by the outer sheet (¶[0010]), in order to prevent leakage caused by the wearer’s physical activity or change of posture (¶[0020]), and to allow urine to be quickly drawn into the urine collection tube to be stored in the urine tank (¶[0034]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davis to include a raised boundary having a single continuous wall portion extending around a periphery of the fluid collection device that is positioned to contact the female user, and so that a drain tube is connected to a connector located at an intermediate region of the fluid impermeable enclosure, the drain tube positioned at the gravimetrically low point in the fluid collection device, and a porous body with a lower surface contacting an inner surface of the fluid impermeable enclosure, as taught by Machida, in order to keep the porous body sealed air tight by the fluid impermeable enclosure (as motivated by Machida ¶[0010]), in order to prevent leakage caused by the wearer’s physical activity or change of posture (as motivated by Machida ¶[0020]) and to allow urine to be quickly drawn into the urine collection tube to be stored in the urine tank (as motivated by Machida ¶[0034]).
Davis/Machida is silent whether the raised boundary has a cross section that includes a single continuous convex contact surface, whether the fluid impermeable enclosure includes an inner surface, the inner surface including a first portion and a second portion at least partially enclosed by the first portion, the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure; and a porous body including an upper surface including discrete holes, and a lower surface contacting the first portion of the inner surface of the fluid impermeable enclosure; wherein the second portion of the inner surface partially defines a substantially unoccupied space between the second portion and the porous body, the aperture adjacent to the substantially unoccupied space, wherein the second portion of the inner surface completely defines an inlet of the aperture.
However, Suydam teaches a portable urinal device, thus from the same field of endeavor, which includes a raised boundary that includes a single continuous convex contact surface (rim 34 comprises a single continuous convex contact surface as shown in Fig 4-5 ¶[0028]) to provide cushioned leak-sealing adjacent to the user’s genitals and to add comfort (¶[0028]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davis/Machida so that the raised boundary has a cross section that includes a single continuous convex contact surface, as taught by Suydam to provide cushioned leak-sealing adjacent to the user’s genitals and to add comfort (as motivated by Suydam ¶[0028]).
Davis/Machida/Suydam is silent regarding whether the fluid impermeable enclosure includes an inner surface, the inner surface including a first portion and a second portion at least partially enclosed by the first portion, the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure; and a porous body including an upper surface including discrete holes, and a lower surface contacting the first portion of the inner surface of the fluid impermeable enclosure; wherein the second portion of the inner surface partially defines a substantially unoccupied space between the second portion and the porous body, the aperture adjacent to the substantially unoccupied space, wherein the second portion of the inner surface completely defines an inlet of the aperture.
However, Okabe teaches a urine disposal device, thus from the same field of endeavor, with a porous body including an upper surface including discrete holes (Fig 4 ¶[0026][0038-0039] combination of perforated urine absorbent sheet 3 and urine absorbing space forming sheet 4 includes a plurality of urine drainage pores 3a in the upper surface thereof) in order to properly maintain negative pressure in the urine absorbing space by providing uniform negative pressure and to increase the percentage of urine collection (¶[0010][0039]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davis/Machida/Suydam so that a porous body includes an upper surface including discrete holes, as taught by Okabe, in order to properly maintain negative pressure in the urine collection device by providing uniform negative pressure and to increase the percentage of urine collection (as motivated by Okabe ¶[0010][0039]).
Davis/Machida/Suydam/Okabe is silent whether the fluid impermeable enclosure includes an inner surface, the inner surface including a first portion and a second portion at least partially enclosed by the first portion, the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure; wherein the second portion of the inner surface partially defines a substantially unoccupied space between the second portion and the porous body, the aperture adjacent to the substantially unoccupied space, wherein the second portion of the inner surface completely defines an inlet of the aperture.
However, Newton teaches a urine collection device, thus from the same field of endeavor, wherein the fluid impermeable enclosure includes an inner surface (Fig 2 ¶[0009] urine collection device includes an impermeable outer layer 16 that defines an inner surface), the inner surface including a first portion (Fig 2, portion of the inner surface adjacent to porous material 12) and a second portion at least partially enclosed by the first portion (Fig 2, ¶[0009] portion of inner surface of 16 defining chamber 18 is enclosed by porous material layer 12), the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure (Fig 2 ¶[0009] port 20); wherein the second portion of the inner surface partially defines a substantially unoccupied space between the second portion and the porous body, the aperture adjacent to the substantially unoccupied space (Fig 2, chamber 18 is an empty space defined by the second portion of the inner surface of 16 and porous layer 12, with port 20 disposed therein), wherein the second portion of the inner surface completely defines an inlet of the aperture (Fig 2, portion of inner surface of 16 defining chamber 18 completely defines the inlet of port 20) in order to collect urine within the chamber for transport (¶[0009]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davis/Machida/Suydam/Okabe so that the fluid impermeable enclosure includes an inner surface, the inner surface including a first portion and a second portion at least partially enclosed by the first portion, the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure; wherein the second portion of the inner surface partially defines a substantially unoccupied space between the second portion and the porous body, the aperture adjacent to the substantially unoccupied space, wherein the second portion of the inner surface completely defines an inlet of the aperture as taught by Newton in order to collect urine within the unoccupied space for transport (as motivated by Newton ¶[0009]). In combination, the porous body taught by Davis would contact the first portion of the inner surface taught by Newton.
Regarding Claim 2, the first embodiment of Davis is silent whether a permeable material is disposed in the reservoir and configured to draw fluid away from the user.
However, in a separate embodiment, Davis teaches that a permeable material (inner collection core 42 is provided as a first layer 42a that surrounds a second layer 42b. In this configuration first layer 42a is considered the permeable material and the second layer 42b is the porous body, Fig 26A ¶[0098] is disposed in the reservoir (cavity ¶[0052] would still be present in this alternate embodiment) and configured to draw fluid away from the user (42 may be moisture wicking ¶[0056) so that layers in direct contact with the anatomy do not feel wet to the user or cause dampness on the user’s skin, improving comfort (¶[0056])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Davis/Machida/Suydam/Okabe with the two layer inner collection core to include a permeable material disposed in the reservoir and configured to draw fluid away from the user, as taught by Davis to further enhance wicking capabilities so that layers in direct contact with the anatomy do not feel wet to the user or cause dampness on the users skin, improving comfort (as motivated by Davis ¶[0056]).
Regarding Claim 3, the first embodiment of Davis/Machida/Suydam/Okabe is silent whether the porous body is embedded in the permeable material and extends longitudinally in the reservoir.
However, the separate embodiment of Davis further teaches that the porous body (second layer 42b is disposed within first layer 42a, Fig 26A-B) is embedded in the permeable material (42a, Fig 26A-B) and extends longitudinally in the reservoir (inner collection core 42 comprising first layer 42a and second layer 42b extends longitudinally in the reservoir created by 40 and 20, Figs 26A-B) to further enhance wicking capabilities so that layers in direct contact with the anatomy do not feel wet to the user or cause dampness on the users skin, improving comfort (¶[0056])
Therefore, it would have been obvious to modify the first embodiment of Davis/Machida/Suydam/Okabe so that the porous body is embedded in the permeable material and extends longitudinally in the reservoir, to further enhance wicking capabilities so that layers in direct contact with the anatomy do not feel wet to the user or cause dampness on the user’s skin, improving comfort (as motivated by Davis ¶[0056])
Regarding Claim 4, the first embodiment of Davis/Machida/Suydam/Okabe is silent whether the permeable material includes at least one of a foam, polyester, or spun nylon material.
However, the separate embodiment of Davis teaches that the permeable material (42a, Fig 26A-B) includes a polyester (inner collection core 42 is manufactured of a polyester ¶[0059] to draw fluid from the outer collection layer 40 and wick it into the cavity without retaining the fluid (¶[0059]).
Therefore, it would have been obvious to modify the first embodiment of Davis/Machida/Suydam/Okabe so that the permeable material includes polyester to draw fluid from the outer collection layer 40 and wick it into the cavity without retaining the fluid (as motivated by Davis ¶[0059]).
Regarding Claim 5, Davis/Machida/Suydam/Okabe discloses that the fluid permeable membrane (40, Fig 7) is positioned to interface with the female anatomy of the user (portion of 40 exposed by fenestration 30 interfaces with the female user’s urethra ¶[0056]).
Regarding Claim 7, Davis/Machida/Suydam/Okabe discloses that the fluid impermeable enclosure (20, Fig 7) includes an exterior surface having an adhesive thereon (external covering 20 may include a medical grade tape ¶[0053]).
Regarding Claim 8, Davis/Machida/Suydam/Okabe discloses two or more side flaps (anchor 50, Fig 1) extending laterally outward from the fluid impermeable enclosure (20, Fig 7).
Regarding Claim 9, Davis/Machida/Suydam/Okabe discloses that each of the two or more side flaps (anchor 50, Fig 1) are positioned to contact the female user and include adhesive thereon (anchor 50 may include adhesive ¶[0088]).
Regarding Claim 10, Davis/Suydam/Okabe is silent whether the raised boundary extends substantially perpendicular to the exterior surface, the one or more boundaries at least partially defining the reservoir of the fluid collection device, the raised boundary comprising an hourglass-shaped outer contour of the fluid collection device.
However, Machida teaches that the raised boundary extends substantially perpendicular to the exterior surface (6 extends substantially perpendicular to outer sheet 5, Fig 5), the one or more boundaries at least partially defining the reservoir of the fluid collection device (6 defines the reservoir created by top sheet 2, hydrophilic sheet 3, and urine absorbent sheet 4, Fig 5), the raised boundary comprising an hourglass-shaped outer contour of the fluid collection device (6 extends around the periphery of outer sheet 5, having an hourglass shaped outer contour as shown in Fig 4) in order to conform to the wearer’s crotch, and to prevent leakage (¶[0017][0020]).
Therefore, it would have been obvious to modify the device of Davis/Suydam/Okabe so that the raised boundary extends substantially perpendicular to the exterior surface, the one or more boundaries at least partially defining the reservoir of the fluid collection device, the raised boundary comprising an hourglass-shaped outer contour of the fluid collection device, as taught by Machida in order to conform to the wearer’s crotch, and to prevent leakage (as motivated by Machida ¶[0017][0020]).
Regarding Claim 11, Davis discloses a fluid collection system (200, Fig 32), comprising:
a fluid collection device (10, Fig 7) configured to be positioned at least proximate a urethra of a female user (a device for collecting and removing urine that has been discharged from the body of a user, in particular a female user ¶[0051])the fluid collection device (10, Fig 7) comprising: a fluid impermeable enclosure (external covering 20 is fluid impermeable ¶[0052]);
a fluid permeable membrane (outer collection layer 40, Fig 7 is fluid permeable ¶[0057]);
a reservoir (cavity defined by external covering 20, Fig 1¶[0052]) at least partially defined by the fluid impermeable enclosure (20, Fig 7) and the fluid permeable membrane (40 defines part of the cavity at the fenestration 30, Fig 7 ), the reservoir (cavity defined by external covering 20, Fig 1¶[0052]) configured to receive fluid discharged from the user through the fluid permeable membrane (fluid flows from a urethral opening of a user’s body through fenestration 30, in which outer collection layer 40 is disposed, into a cavity defined by external covering 20, Fig 1 ¶[0052]);
a porous body (inner collection core 42 may be a polyester filter foam material that wicks fluid from the outer collection layer 40 into the cavity without retaining the fluid, and thus may be porous, Fig 7 ¶[0059]) disposed in the reservoir (cavity defined by external covering 20, Fig 1¶[0052]);
and a drain tube (32, Fig 7) coupled to an intermediate region of the fluid impermeable enclosure (20, Fig 7 Drain tube 32 is coupled to the intermediate region of 20 as it is disposed within inner collection core 42 and fluid permeable membrane 40, thus 32 is coupled to the entire fluid impermeable enclosure 20, Fig 7 ¶[0060]), the drain tube (32, Fig 7) in fluid communication with the reservoir (cavity ¶[0052]) and the porous body (42, Fig 7), the drain tube (32, Fig 7) positioned and configured to drain the fluid (fluid collection in device 10 is evacuated from device 10 through tube 32, Fig 7 ¶[0060]) that flows through the porous body via the aperture (fluid must pass through 40 and 42 to be evacuated from 10 through 32, Fig 7);
a vacuum source (210, Fig 32) configured to draw fluid from the fluid collection device (10, Fig 32) by applying at least a partial suction force (vacuum source 210 provides suction through the tube 32 ¶[0107]) to the reservoir (cavity ¶[0052]) of the fluid collection device (10, Fig 32); and
a fluid collection container (external reservoir 204, Fig 32) in fluid communication with the drain tube (tube 32 is in fluid communication with 204 via discharge tube line 202, Fig 32 ¶[0107]).
The first embodiment of Davis is silent whether the fluid impermeable enclosure exhibits a planar hourglass-shaped outer contour, the fluid impermeable enclosure including an inner surface, the inner surface including a first portion and a second portion at least partially enclosed by the first portion, the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure; a raised boundary having a single continuous wall portion extending around a periphery of the fluid collection device that includes a single continuous convex contact surface positioned to contact the female user, and whether the drain tube is positioned at a gravimetrically low point in the fluid collection device, and whether a porous body includes an upper surface including discrete holes and a lower surface contacting the first portion of the inner surface of the fluid impermeable enclosure; wherein the second portion of the inner surface partially defines a substantially unoccupied space between the second portion and the porous body, the aperture adjacent to the substantially unoccupied space.
However, an separate embodiment of Davis teaches that the fluid impermeable enclosure exhibits a single continuous hourglass-shaped outer contour (an alternative shape of the external covering 20 wherein 20 has a planar hourglass-shaped outer contour, Fig 8 ¶[0055]) in order to provide a better contoured fit for the user’s pubic region, perineum, and coccyx (¶[0055]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid permeable enclosure of the first embodiment of Davis so that the fluid impermeable enclosure exhibits a single continuous hourglass-shaped outer contour, as taught by the embodiment of Davis in Figure 8, in order to provide a better contoured fit for the user’s pubic region, perineum, and coccyx (as motivated by Davis ¶[0055]).
Davis is silent regarding a cross-section having a raised boundary having a single continuous wall portion extending around a periphery of the fluid collection device that includes a single continuous convex contact surface positioned to contact the female user; whether the fluid impermeable enclosure includes an inner surface, the inner surface including a first portion and a second portion at least partially enclosed by the first portion, the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure; and whether the drain tube is positioned at a gravimetrically low point in the fluid collection device, and whether a porous body includes an upper surface including discrete holes and a lower surface contacting the first portion of the inner surface of the fluid impermeable enclosure.
However, Machida teaches an automatic urine disposal device, thus from the same field of endeavor, with a raised boundary having a single continuous wall portion (outer sheet 5 and gathers 6, Fig 5) extending around a periphery of the fluid collection device (gathers 6 extends along the periphery of outer sheet 5, Fig 5) that is positioned to contact the female user (gathers 6 are disposed on the top side of the urine collecting pad 1 which contacts the user, Fig 5), and a drain tube (urine drainage tube 8, Fig 1) positioned at the gravimetrically low point in the fluid collection device (8 is positioned at the center-most low point of device 1 as shown in Fig 1), and a porous body with a lower surface contacting an inner surface of the fluid impermeable enclosure (Fig 5 ¶[0010][0021][0043] urine absorbent sheet 4 may be porous and has a lower surface contacting an inner surface of impermeable outer sheet 5) in order to keep the urine absorbent sheet sealed air tight by the outer sheet (¶[0010]), in order to prevent leakage caused by the wearer’s physical activity or change of posture (¶[0020]), and to allow urine to be quickly drawn into the urine collection tube to be stored in the urine tank (¶[0034]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davis to include a raised boundary having a single continuous wall portion extending around a periphery of the fluid collection device that is positioned to contact the female user, and so that a drain tube is connected to a connector located at an intermediate region of the fluid impermeable enclosure, the drain tube positioned at the gravimetrically low point in the fluid collection device, and a porous body with a lower surface contacting an inner surface of the fluid impermeable enclosure, as taught by Machida, in order to keep the porous body sealed air tight by the fluid impermeable enclosure (as motivated by Machida ¶[0010]), in order to prevent leakage caused by the wearer’s physical activity or change of posture (as motivated by Machida ¶[0020]) and to allow urine to be quickly drawn into the urine collection tube to be stored in the urine tank (as motivated by Machida ¶[0034]).
Davis/Machida is silent whether the raised boundary has a cross section that includes a single continuous convex contact surface, whether the fluid impermeable enclosure includes an inner surface, the inner surface including a first portion and a second portion at least partially enclosed by the first portion, the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure; and a porous body including an upper surface including discrete holes, and a lower surface contacting the first portion of the inner surface of the fluid impermeable enclosure; wherein the second portion of the inner surface partially defines a substantially unoccupied space between the second portion and the porous body, the aperture adjacent to the substantially unoccupied space.
However, Suydam teaches a portable urinal device, thus from the same field of endeavor, which includes a raised boundary that includes a single continuous convex contact surface (rim 34 comprises a single continuous convex contact surface as shown in Fig 4-5 ¶[0028]) to provide cushioned leak-sealing adjacent to the user’s genitals and to add comfort (¶[0028]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davis/Machida so that the raised boundary has a cross section that includes a single continuous convex contact surface, as taught by Suydam to provide cushioned leak-sealing adjacent to the user’s genitals and to add comfort (as motivated by Suydam ¶[0028]).
Davis/Machida/Suydam is silent regarding whether the fluid impermeable enclosure includes an inner surface, the inner surface including a first portion and a second portion at least partially enclosed by the first portion, the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure; and a porous body including an upper surface including discrete holes, and a lower surface contacting the first portion of the inner surface of the fluid impermeable enclosure; wherein the second portion of the inner surface partially defines a substantially unoccupied space between the second portion and the porous body, the aperture adjacent to the substantially unoccupied space.
However, Okabe teaches a urine disposal device, thus from the same field of endeavor, with a porous body including an upper surface including discrete holes (Fig 4 ¶[0026][0038-0039] combination of perforated urine absorbent sheet 3 and urine absorbing space forming sheet 4 includes a plurality of urine drainage pores 3a in the upper surface thereof) in order to properly maintain negative pressure in the urine absorbing space by providing uniform negative pressure and to increase the percentage of urine collection (¶[0010][0039]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davis/Machida/Suydam so that a porous body includes an upper surface including discrete holes, as taught by Okabe, in order to properly maintain negative pressure in the urine collection device by providing uniform negative pressure and to increase the percentage of urine collection (as motivated by Okabe ¶[0010][0039]).
Davis/Machida/Suydam/Okabe is silent whether the fluid impermeable enclosure includes an inner surface, the inner surface including a first portion and a second portion at least partially enclosed by the first portion, the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure; wherein the second portion of the inner surface partially defines a substantially unoccupied space between the second portion and the porous body, the aperture adjacent to the substantially unoccupied space.
However, Newton teaches a urine collection device, thus from the same field of endeavor, wherein the fluid impermeable enclosure includes an inner surface (Fig 2 ¶[0009] urine collection device includes an impermeable outer layer 16 that defines an inner surface), the inner surface including a first portion (Fig 2, portion of the inner surface adjacent to porous material 12) and a second portion at least partially enclosed by the first portion (Fig 2, ¶[0009] portion of inner surface of 16 defining chamber 18 is enclosed by porous material layer 12), the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure (Fig 2 ¶[0009] port 20); wherein the second portion of the inner surface partially defines a substantially unoccupied space between the second portion and the porous body, the aperture adjacent to the substantially unoccupied space (Fig 2, chamber 18 is an empty space defined by the second portion of the inner surface of 16 and porous layer 12, with port 20 disposed therein) in order to collect urine within the chamber for transport (¶[0009]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davis/Machida/Suydam/Okabe so that the fluid impermeable enclosure includes an inner surface, the inner surface including a first portion and a second portion at least partially enclosed by the first portion, the fluid impermeable enclosure defining an aperture in an intermediate region of the fluid impermeable enclosure; wherein the second portion of the inner surface partially defines a substantially unoccupied space between the second portion and the porous body, the aperture adjacent to the substantially unoccupied space, as taught by Newton in order to collect urine within the unoccupied space for transport (as motivated by Newton ¶[0009]). In combination, the porous body taught by Davis would contact the first portion of the inner surface taught by Newton.
Regarding Claim 12, the first embodiment of Davis/Machida/Suydam/Okabe is silent whether a permeable material is disposed in the reservoir, wherein the porous body is embedded in the permeable material and extends longitudinally in the reservoir.
However, the separate embodiment of Davis further teaches that a permeable material (42a, Fig 26A-B) is disposed in the reservoir (inner collection core 42 comprising first layer 42a and second layer 42b extends longitudinally in the reservoir created by 40 and 20, Figs 26A-B, wherein the porous body (second layer 42b is disposed within first layer 42a, Fig 26A-B) is embedded in the permeable material (42a, Fig 26A-B) and extends longitudinally in the reservoir (inner collection core 42 comprising first layer 42a and second layer 42b extends longitudinally in the reservoir created by 40 and 20, Figs 26A-B) to further enhance wicking capabilities so that layers in direct contact with the anatomy do not feel wet to the user or cause dampness on the users skin, improving comfort (¶[0056]).
Therefore, it would have been obvious to modify the first embodiment of Davis/Machida/Suydam/Okabe so that a permeable material is disposed in the reservoir, wherein the porous body is embedded in the permeable material and extends longitudinally in the reservoir, to further enhance wicking capabilities so that layers in direct contact with the anatomy do not feel wet to the user or cause dampness on the user’s skin, improving comfort (as motivated by Davis ¶[0056]).
Regarding Claim 17, Davis/Machida/Suydam/Okabe discloses that the fluid collection container (204, Fig 32) is configured to be removable and replaceable (210 may be sterilized after a use and reused ¶[0107]).
Regarding Claim 21, Davis discloses a fluid collection device (urine collection device 10, Fig 7) configured to be positioned at least proximate a urethra of a female user (a device for collecting and removing urine that has been discharged from the body of a user, in particular a female user ¶[0051]), the fluid collection device (10, Fig 7) comprising:
a fluid impermeable enclosure (external covering 20 is fluid impermeable ¶[0052]);
a fluid permeable membrane (outer collection layer 40, Fig 7 is fluid permeable ¶[0057]);
a reservoir (cavity defined by external covering 20, Fig 1¶[0052]) at least partially defined by the fluid impermeable enclosure (20, Fig 7) and the fluid permeable membrane (40 defines part of the cavity at the fenestration 30, Fig 7), the reservoir (cavity defined by external covering 20, Fig 1¶[0052]) configured to receive fluid discharged from the user through the fluid permeable membrane (fluid flows from a urethral opening of a user’s body through fenestration 30, in which outer collection layer 40 is disposed, into a cavity defined by external covering 20, Fig 1 ¶[0052]);
a porous body (inner collection core 42 may be a polyester filter foam material that wicks fluid from the outer collection layer 40 into the cavity without retaining the fluid, and thus may be porous, Fig 7 ¶[0059]) disposed in the reservoir (cavity defined by external covering 20, Fig 1¶[0052]); and
a drain tube (32, Fig 7) connected to an intermediate region of the fluid impermeable enclosure (20, Fig 7 Drain tube 32 is coupled to the intermediate region of 20 as it is disposed within inner collection core 42 and fluid permeable membrane 40, thus 32 is coupled to the entire fluid impermeable enclosure 20, Fig 7 ¶[0060]), the drain tube (32, Fig 7) in fluid communication with the reservoir (cavity ¶[0052]) and the porous body (42, Fig 7), the drain tube (32, Fig 7) positioned and configured to drain the fluid (fluid collection in device 10 is evacuated from device 10 through tube 32, Fig 7 ¶[0060]) that flows through the porous body (fluid must pass through 40 and 42 to be evacuated from 10 through 32, Fig 7).
The first embodiment of Davis is silent whether the fluid impermeable enclosure exhibits a planar hourglass-shaped outer contour including a cross-section having a single continuous convex contact surface positioned around a single continuous wall portion located at the periphery configured to contact a female user, and whether the drain tube is positioned at a gravimetrically low point in the fluid collection device, and whether a porous body includes an upper surface including discrete holes and a lower surface contacting an inner surface of the fluid impermeable enclosure; wherein at least a majority of the fluid permeable membrane partially defines a substantially unoccupied space between the fluid permeable membrane and the porous body.
However, an separate embodiment of Davis teaches that the fluid impermeable enclosure exhibits a planar hourglass-shaped outer contour (an alternative shape of the external covering 20 wherein 20 has a planar hourglass-shaped outer contour, Fig 8 ¶[0055]) in order to provide a better contoured fit for the user’s pubic region, perineum, and coccyx (¶[0055]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid permeable enclosure of the first embodiment of Davis so that the fluid impermeable enclosure exhibits a planar hourglass-shaped outer contour, as taught by the embodiment of Davis in Figure 8, in order to provide a better contoured fit for the user’s pubic region, perineum, and coccyx (as motivated by Davis ¶[0055]).
Davis is silent regarding a cross-section having a single continuous convex contact surface positioned around a single continuous wall portion located at the periphery configured to contact a female user, a drain tube is connected to a connector located at an intermediate region of the fluid impermeable enclosure, the drain tube positioned at the gravimetrically low point in the fluid collection device, and whether a porous body includes an upper surface including discrete holes and a lower surface contacting an inner surface of the fluid impermeable enclosure; wherein at least a majority of the fluid permeable membrane partially defines a substantially unoccupied space between the fluid permeable membrane and the porous body.
However, Machida teaches an automatic urine disposal device, thus from the same field of endeavor, with a single continuous wall portion (outer sheet 5 and gathers 6, Fig 5) extending around a periphery of the fluid collection device (gathers 6 extends along the periphery of outer sheet 5, Fig 5) that is positioned to contact the female user (gathers 6 are disposed on the top side of the urine collecting pad 1 which contacts the user, Fig 5), a drain tube (urine drainage tube 8, Fig 1) connected to a connector (8 is connected to through urine drainage port 7, Fig 1) located at an intermediate region of the fluid impermeable enclosure (port 7 is located at an intermediate region of the fluid impermeable enclosure created by fluid impermeable outer sheet 5 and gathers 6, Fig 5 ¶[0018]), the drain tube (8, Fig 1) positioned at the gravimetrically low point in the fluid collection device (8 is positioned at the center-most low point of device 1 as shown in Fig 1), and a porous body with a lower surface contacting an inner surface of the fluid impermeable enclosure (Fig 5 ¶[0010][0021][0043] urine absorbent sheet 4 may be porous and has a lower surface contacting an inner surface of impermeable outer sheet 5) in order to keep the urine absorbent sheet sealed air tight by the outer sheet (¶[0010]), in order to prevent leakage caused by the wearer’s physical activity or change of posture (¶[0020]), and to allow urine to be quickly drawn into the urine collection tube to be stored in the urine tank (¶[0034]).
Therefore, it would have been obvious to modify the device of Davis to include a single continuous wall portion extending around a periphery of the fluid collection device that is positioned to contact the female user and a drain tube that is connected to a connector located at an intermediate region of the fluid impermeable enclosure, the drain tube positioned at the gravimetrically low point in the fluid collection device, and a porous body with a lower surface contacting an inner surface of the fluid impermeable enclosure, as taught by Machida, in order to keep the porous body sealed air tight by the fluid impermeable enclosure (as motivated by Machida ¶[0010]), in order to prevent leakage caused by the wearer’s physical activity or change of posture (as motivated by Machida ¶[0020]) and to allow urine to be quickly drawn into the urine collection tube to be stored in the urine tank (as motivated by Machida ¶[0034]).
Davis/Machida is silent regarding a cross-section having a single continuous convex contact surface, and whether a porous body includes an upper surface including discrete holes; wherein at least a majority of the fluid permeable membrane partially defines a substantially unoccupied space between the fluid permeable membrane and the porous body.
.
However, Suydam teaches a portable urinal device, thus from the same field of endeavor, which includes an outer contour that includes a single continuous convex contact surface (rim 34 comprises a single continuous convex contact surface as shown in Fig 4-5 ¶[0028]) to provide cushioned leak-sealing adjacent to the user’s genitals and to add comfort (¶[0028]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davis/Machida so that the outer contour has a cross section that includes a single continuous convex contact surface, as taught by Suydam to provide cushioned leak-sealing adjacent to the user’s genitals and to add comfort (as motivated by Suydam ¶[0028]).
Davis/Machida/Suydam is silent regarding a porous body including an upper surface including discrete holes; wherein at least a majority of the fluid permeable membrane partially defines a substantially unoccupied space between the fluid permeable membrane and the porous body.
However, Okabe teaches a urine disposal device, thus from the same field of endeavor, with a porous body including an upper surface including discrete holes (Fig 4 ¶[0026][0038-0039] combination of perforated urine absorbent sheet 3 and urine absorbing space forming sheet 4 includes a plurality of urine drainage pores 3a in the upper surface thereof); wherein at least a majority of the fluid permeable membrane partially defines a substantially unoccupied space between the fluid permeable membrane and the porous body (Fig 5 ¶[0018] liquid permeable top sheet 2 and urine absorbing space forming sheet defines an unoccupied space extending through each aperture 3a) in order to properly maintain negative pressure in the urine absorbing space by providing uniform negative pressure and to increase the percentage of urine collection (¶[0010][0039]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davis/Machida/Suydam so that a porous body includes an upper surface including discrete holes, wherein at least a majority of the fluid permeable membrane partially defines a substantially unoccupied space between the fluid permeable membrane and the porous body as taught by Okabe, in order to properly maintain negative pressure in the urine collection device by providing uniform negative pressure and to increase the percentage of urine collection (as motivated by Okabe ¶[0010][0039]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (US 20180228642 A1) in view of Machida (US 20050033248 A1), in view of Suydam (US 20020193762 A1), further in view of Okabe (US 20040254547 A1), and further in view of Wilcox (US 8277426 B2).
Regarding Claim 6, Davis/Machida/Suydam/Okabe is silent whether the fluid permeable membrane includes a woven cotton material.
However, Wilcox teaches a urinary incontinence device, thus from the same field of endeavor, wherein the fluid permeable membrane (liquid permeable liner 24, Fig 1) includes a woven cotton material (24 may be woven cotton, Fig 1 col 5 ln 6-8) to allow discharged urine to pass through freely and to keep the genitalia separated from the discharged urine (Col 4 ln 47-Col 5 ln 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davis/Machida/Suydam/Okabe so that the fluid permeable membrane includes a woven cotton material, as taught by Wilcox, to allow discharged urine to pass through freely and to keep the genitalia separated from the discharged urine (Col 4 ln 47-Col 5 ln 2). This is a simple substitution of one urine permeable material for another known urine permeable material which would result in a predictable change because both the outer collection layer 40 of Davis (Davis ¶[0057]) and the woven cotton liner 24 of Wilcox (col 5 ln 6-8) are known to be fluid permeable and allow urine to pass through freely and would be obvious to once of ordinary skill in the art.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (US 20180228642 A1) in view of Machida (US 20050033248 A1), in view of Suydam (US 20020193762 A1), further in view of Okabe (US 20040254547 A1), further in view of Newton (US 20180049910 A1), further in view of Van Middendorp (US 20170281399 A1).
Regarding Claim 13, Davis/Machida/Suydam/Okabe/Newton is silent whether the vacuum source includes a peristaltic pump or a micropump.
However, Van Middendorp teaches a urine collection system, thus from the same field of endeavor, wherein the vacuum source (suction device 152) includes a peristaltic pump (152 is a peristaltic pump ¶[0069]).
Therefore, it would have been obvious to simply substitute the generic vacuum pump of Davis/Machida/Suydam/Okabe/Newton with the specific peristaltic pump taught by Van Middendorp, as Van Middendorp shows that peristaltic pumps are well known in the art for use with urine collection systems.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Davis (US 20180228642 A1) in view of Machida (US 20050033248 A1), in view of Suydam (US 20020193762 A1), further in view of Okabe (US 20040254547 A1), further in view of Newton (US 20180049910 A1), and further in view of Harvie (US 7141043 B2).
Regarding Claims 14 and 15, Davis/Machida/Suydam/Okabe/Newton is silent whether the fluid collection container and the vacuum source include one or more straps configured to secure to the user, and wherein the fluid collection container and the vacuum source are sized and dimensioned to couple to a leg of a user.
However, Harvie teaches an automatic bladder relief system, thus from the same field of endeavor, wherein the fluid collection container (urine collection bag 3, Fig 1) and the vacuum source (suction vacuum pump 2, Fig 6) include one or more straps configured to secure to the user (Fig 2 shows suction control unit 1 secured to a person’s leg by a strap (not labeled) Suction control unit contains vacuum pump 2 as shown in Fig 6, and provides attachment to collection bag 3 via hose coupling 17, as shown in Fig 1), and wherein the fluid collection container (collection bag 3, Fig 1) and the vacuum source (vacuum pump 2, Fig 6) are sized and dimensioned to couple to a leg of a user (Fig 2 shows suction control unit 1, which is molded and adjustable to fit the curve of the thigh, secured to a person’s leg by a strap (not labeled) Suction control unit contains vacuum pump 2 as shown in Fig 6, and provides attachment to collection bag 3 via hose coupling 17, as shown in Fig 1) to strap the device to the user’s thigh without giving the appearance of wearing bladder relief equipment (col 8 ln 56-61) This allows the system to be portable and in constant use.
Therefore, it would have been obvious to modify the system of Davis/Machida/Suydam/Okabe/Newton so that the fluid collection container and the vacuum source include one or more straps configured to secure to the user, and wherein the fluid collection container and the vacuum source are sized and dimensioned to couple to a leg of a user, as taught by Harvie to strap the device to the user’s thigh without giving the appearance of wearing bladder relief equipment (as motivated by Harvie col 8 ln 56-61). This allows the system to be portable and in constant use.
Regarding Claim 16, Davis/Machida/Suydam/Okabe/Newton is silent whether the fluid collection container includes an absorbent material.
However, Harvie teaches that the fluid collection container (urine collection bag 3, Fig 8) includes an absorbent material (collection bag 3 contains super absorbent polymer crystals 62, Fig 8) to absorb the urine as it is being deposited in the bag ([abstract]) thereby reducing the risk of spillage or leakage.
Therefore, it would have been obvious to modify the system of Davis/Machida/Suydam/Okabe so that the fluid collection container includes an absorbent material, as taught by Harvie, to absorb the urine as it is being deposited in the bag (as motivated by Harvie [abstract]) thereby reducing the risk of spillage or leakage.
Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Davis (US 20180228642 A1) in view of Machida (US 20050033248 A1), in view of Suydam (US 20020193762 A1), further in view of Okabe (US 20040254547 A1), further in view of Newton (US 20180049910 A1), and further in view of Wada (US 20110040267 A1).
Regarding Claim 18, Davis/Machida/Suydam/Okabe/Newton is silent whether a controller is operatively coupled to the vacuum source.
However, Wada teaches a urine suction device, thus from the same field of endeavor, wherein a controller (urine detector unit 102b, Fig 1) is operatively coupled to the vacuum source (102b is coupled to pump 108 via wiring 116, Fig 1 ¶[0045]) to actuate the pump unit 108 to facilitate automated suction into the reservoir 106a ¶[0045]).
Therefore, it would have been obvious to modify the system of Davis/Machida/Suydam/Okabe so that a controller is operatively coupled to the vacuum source, as taught by Wada to actuate the pump unit to facilitate automated suction into the reservoir (as motivated by Wada ¶[0045]) Automatic suction of urine would improve the comfort of the user by reducing the duration that urine is in contact with the user and amount of urine that is in contact with the user.
Regarding Claim 20, Davis/Machida/Suydam/Okabe is silent whether a power source is operatively coupled to the vacuum source and the controller.
However, Wada teaches a power source (116a, Fig 6) operatively coupled to the vacuum source (108, Fig 1) and the controller (urine detector unit 102b, Fig 1) because the power source powers the vacuum pump and allows the controller to generate signals.
Therefore, it would have been obvious to modify the system of Davis/Machida/Suydam/Okabe to include a power source operatively coupled to the vacuum source and the controller, as taught by Wada, because the power source powers the vacuum pump and allows the controller to generate signals.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Davis (US 20180228642 A1) in view of Machida (US 20050033248 A1), in view of Suydam (US 20020193762 A1), further in view of Okabe (US 20040254547 A1), further in view of Newton (US 20180049910 A1), further in view of Wada (US 20110040267 A1), and further in view of Martin (US 4631061 A).
Regarding Claim 19, Davis/Machida/Suydam/Okabe/Newton/Wada is silent whether the controller may be configured to determine the volume of fluid in the fluid collection system.
However, Martin teaches an automatic urine detecting, collecting, and storing device, thus from the same field of endeavor, wherein the controller (control, such as a solenoid, for activating vacuum pump 43 col 3 ln 46-47) may be configured to determine the volume of fluid in the fluid collection system (tank 32 may include level sensors 40, which would be wired into the control for the vacuum pump so that when the tank reached the 90% full mark, the level sensor 40 would automatically shut off the vacuum pump 43. Col 4 ln 54-58) to prevent the tank from overflowing (col 4 ln 54-58).
Therefore, it would have been obvious to modify the system of Davis/Machida/Suydam/Okabe/Newton/Wada so that the controller may be configured to determine the volume of fluid in the fluid collection system, as taught by Martin, to prevent the tank from overflowing (as motivated by Martin col 4 ln 54-58).
Conclusion
THIS ACTION IS MADE FINAL. 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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/TIMOTHY L FLYNN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781