DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The examiner notes that the amendment filed 06/04/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5,8,14-16,18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 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.
Claim(s) 1-5,8, 14-16,18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ecklund et al. US 2019/0247222 in view of Cheng et al. US 2004/0176731, previously provided, and further in view of Krishnaswamy-Mirle et al. US 7179951, hereafter Krishnaswamy-Mirle.
Regarding claim 1, Ecklund discloses a urine collection device(abstract, figure 16a), comprising: a tube (1679) having an inlet (portion attached to 1694); a fluid permeable body (permeable layer 1690D and wicking layer 1690E, where, in construction the male member is placed adjacent said layers [para. 0188)) having a first side, a second side, a proximal edge, and two side edges extending from the proximal edge towards the inlet (the examiner notes that per para. 0188 as 1690D and 1690E form the fluid permeable barrier. It is interpreted that 1690E is the first side, 1690D is the second side, the proximal edge is the portion adjacent to the proximal edge of the device as a whole, and the two side edges are the perimeters of both 1690D and 1690E));
The examiner notes that while Ecklund discloses a fluid impermeable barrier (1690C) covering and interfacing substantially all of the first side, the proximal edge, and the two side edges of the fluid permeable body effective to prevent fluid communication into the fluid permeable body through the first side, the proximal edge, and the two side edges of the fluid permeable body (seen covering the defined first side and therefore at least a portion of the proximal and side edges), the examiner instead interprets the walls 1690A and 1690B as the fluid impermeable barrier. As seen in construction, figure 16B and 16C, show that said walls form the exterior barrier of the device, and thus cover the entire permeable barrier. While the examiner notes that one of ordinary skill in the art would determine that said walls are fluid impermeable, as they function as the exterior structure of the device and thus allowing fluid through said walls would cause the function of the device to fail, however, the examiner brings in Cheng to specifically teach this limitation.
Cheng teaches a urine collection device and is thus considered analogous to the claimed invention. Cheng teaches that such devices known in the art comprise a wicking material for collecting fluid (wicking material 237, figure 3b), where the device further comprises an outermost layer that is impervious to fluid to prevent leaking (outer impervious layer (236), see para. 0114, see also para. 0028 where impervious layer surrounds the intake layer). As such, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the outer walls of Ecklund to be fluid impervious to prevent leakage of fluid out of the device. Doing so would yield the predictable result of providing a urine collection device that would prevent leakage out of the outmost layer of the device.
The examiner further notes the Ecklund (in view of Cheng) teaches wherein the fluid impermeable barrier (outer wall formed by 1690A and 1690B) defines an aperture providing fluid communication between the fluid permeable body and at least a portion of the tube (seam 1699, see para. 0193, where said seam in the collection device allows the tube to extend through into the device); and a chamber sized to receive at least a portion of a penis therein to position a portion of the penis adjacent to a portion of the fluid permeable body (internal cavity 1638, see figure 16C).
The examiner notes that per the amendments filed 06/04/2026, claim 1 further requires that the fluid impermeable barrier is “secured to substantially all of the proximal edge and the two side edgers of the fluid permeable body…with one or more of an adhesive, a press fit, a molding, or a combination thereof, the fluid impermeable barrier covering and abutting substantially all of the first side”. The examiner notes that as detailed above under the same rejection, the fluid impermeable barrier is understood to cover and abut substantially all of the first side. While there is no specific disclosure that the impermeable barrier of Ecklund is secured to the fluid permeable body by an adhesive (or other means), Ecklund does disclose that, in a separate embodiment, sheets forming the external fluid collection device may be coupled to each other by heat sealing means.
Cheng, previously combined, teaches that the outer pervious walls are sealed together by thermal or adhesive bonds (para. 0214). Therefore, as Cheng teaches that thermal bonds or adhesive bonds are suitable to connect layers of a fluid collection device together, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use an adhesive bond in place of the thermal bond taught by Ecklund, to secure the layers together. Doing so would merely require the simple substitution of one known element for another to obtain predictable results, that being the sealing of layer together, and thus a prima facie case of obviousness exists.
Should applicant argue that even upon combination, the outer layers are not specifically secured to the fluid permeable body, the examiner further relies on Krishnaswamy-Mirle.
Krishnaswamy-Mirle teaches an absorbent article and is thus considered analogous to the claimed invention. Krishnaswamy-Mirle teaches that suitably, “the outer cover may be secured to the absorbent barrier structure by a uniform continuous layer of adhesive (column 21, lines 10-26), where said “combined structure” provides the desired balance of properties including absorbency, barrier property, and convective air permeability (column 21, lines 27-33), the latter of which leads to lower humidity and reduction of irritation (column 21, lines 35-44). Therefore, as Krishnaswamy-Mirle teaches that an outer cover and absorbent core may suitably be attached to one another through an adhesive and provide desirable effects including lowering of humidity and irritation, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to further secure the outer cover to the article of Ecklund to the absorbent to attain a further reduction in humidity and irritation. Doing so would merely require the use of known technique to improve similar devices (methods, or products) in the same way, and thus a prima facie case of obviousness exists.
Regarding claim 2, Ecklund, Cheng, and Krishnaswamy-Mirle teach the urine collection device of claim 1, wherein: the fluid impermeable barrier includes a bottom portion (1690A) defining an opening sized to receive at least a portion of a penis therethrough (aperture 1624), a top portion (1690B) opposite to the bottom portion (see figure 16a), a proximal end region (end with aperture 1624 and connecting to adhering members 1626A and B), a distal end region (end opposite proximal, seen with tubing 1630), and a proximal edge portion (fig. 16A, 1618B, where the edge portion is interpreted as the edge of the wall 1690A that forms a portion of the aperture) defining a proximal slot (narrow portion leading into the aperture), the fluid impermeable barrier defining the chamber between the top portion and the bottom portion of the fluid impermeable barrier (chamber 1638 formed between both walls); the fluid permeable body is positioned within the chamber (where figure 16A shows walls encompassing the defined permeable body, where para. 0188 places the defined permeable body within the chamber) and includes a distal portion positioned in or proximate to the distal end region of the fluid impermeable barrier (where the interpretation of the distal portion of the permeable body is consistent with the distal end of the walls), the proximal edge being positioned within the proximal slot such that the proximal edge interfaces the proximal edge portion of the fluid impermeable barrier (where the permeable barrier 1690E comprises a top edge (interpreted as a proximal edge portion of the impermeable barrier, is within the chamber formed by the wall and thus the proximal slot, and further where the penis received in the chamber is placed between the permeable layers); and the tube extends into the chamber and the inlet is positioned within the chamber proximate to the distal end region of the fluid impermeable barrier (figure 16a where the tube is seen extending into the defined chamber and where para. 0193, discloses that the seam in the collection device allows the tube to extend through into the device). An annotated figure highlighting the limitations mapped for claim 2 is provided below.
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Regarding claim 3, Ecklund, Cheng, and Krishnaswamy-Mirle teach the urine collection device of claim 2, wherein: the fluid impermeable barrier includes an additional edge portion (1618B) defining an additional slot (defining the right portion of the slot as seen in figure 16a) surrounding the opening such that the fluid impermeable barrier extends continuously from the bottom portion of the fluid impermeable barrier, through the opening, and at least partially into the chamber (figure 16a, where the barrier is seen to extend the length of the device); and the fluid permeable body includes an additional edge (proximal edge of the portion of the fluid permeable barrier 1690D) positioned within the additional slot such that the additional edge interfaces the additional edge portion of the fluid impermeable barrier and surrounds at least a portion of the opening (where said permeable barriers are within the chamber and interface with the opening as the permeable barrier edges are configured to receive the penis per para. 0188).
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Regarding claim 4, Ecklund, Cheng, and Krishnaswamy-Mirle teach the urine collection device of claim 2 wherein: the fluid impermeable barrier includes a first side edge portion defining a first side slot and a second side edge portion defining a second slot, each of the first side slot and the second side slot extending at least partially between the proximal edge portion and the distal end region of the chamber; and the two side edges of the fluid permeable body include a first side edge positioned within the first side slot such that the first side edge interfaces the first side edge portion and a second side edge positioned within the second side slot such that the second side edge interfaces the second side edge portion. See annotated figure below. The examiner notes that the bottom wall of the impermeable barrier (1690B) has corresponding side edge portions to the ones identified in the annotated figure, such that, when the top and bottom impermeable barrier portions are combined, the side edges and corresponding side edges form a completed barrier with a chamber inside. The areas at which the top and bottom are joined are interpreted as the side slots of the claimed limitation. Further, the permeable barrier has corresponding side edges which are interpreted to be interfaced within the impermeable barrier side edges and slots as the permeable layers form a space within the chamber formed by the impermeable barrier side edges. See also figure 16B.
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Regarding claim 5, Ecklund, Cheng, and Krishnaswamy-Mirle teach the urine collection device of claim 2, wherein the distal portion of fluid permeable body forms a distal slot that covers the inlet and at least some of the tube. The examiner notes that as seen in figure 16a, the distal portion of the permeable body (1690E and 1690D) overlays the inlet of tubing (1679). The examiner notes that per the rejection of claim 1, the tubing is attached to the layer (1694) and thus it is interpreted that the permeable membranes (Which cover layer 1694) further covers the inlet and at least some of the tube. This overlay, formed by the tube being in between multiple layers, is interpreted to be a slot.
Regarding claim 8, Ecklund, Cheng, and Krishnaswamy-Mirle teach the urine collection device of claim 1,wherein the fluid permeable body includes a fluid permeable porous fiber structure (para. 0190, where the permeable layer 1690D can be a natural or synthetic fiber layer with a moisture transfer channel through the layer [thus interpreted to be porous]) and an outer fluid permeable wicking material (Ecklund wicking layer 1690E, interpreted to be an outer layer since said layer forms at least an outer layer of the fluid permeable barrier [see second side per the annotated figure under the rejection of claim 14).
Regarding claim 14, Ecklund teaches a method of collecting urine, the method comprising: positioning a penis on a first side of a fluid permeable body in a chamber of a urine collection device (figure 16A-D,20, para. 0065). The examiner notes that per paragraph 0065, the embodiments described have an aperture through which a penis is inserted into. The aperture of figure 16A is [1624, per paragraph 0184] is part of the attachment member. The device itself further comprises an opening (1636) for providing access to the internal cavity (para. 0187). Therefore, the penis is inserted through both aperture 1624 and opening 1636 in use. Per paragraph 0188, the device comprises permeable layer (1690D) and wicking layer (1690E), where, in construction the male member is placed on layer 1690D [para. 0188). Thus, the penis is positioned on a first side of a fluid permeable body in a chamber formed by the barrier (joining of layers 1690A and 1690B). The first side is interpreted as the top side of 1690D.
Ecklund further teaches the fluid permeable body having a second side opposite to the first side (bottom side of 1690E), a proximal edge, and two side edges extending from the proximal edge towards a distal end region of the urine collection device (see annotated figure below, where the distal end of the permeable layers corresponds to the distal end of the device); drawing urine through the fluid permeable body to an inlet of a tube at the distal end region of the urine collection device (para. 0192 where urine is egressed through the device to outlet 1630, where outlet includes a tube (1679)), wherein substantially all of the second side, the proximal edge, and the two side edges of the fluid permeable body are covered and interfaced by a fluid impermeable barrier such that the urine is drawn only through the first side of the fluid permeable body positioned against the penis (para. 0188, figure 16A,16C, where the permeable area is surrounded by impermeable barriers 1690A,B); and drawing at least some of the urine through the inlet of the tube and out of the urine collection device (para. 0192).
As seen in construction, figure 16B and 16C, show that said walls form the exterior barrier of the device, and thus cover the entire permeable barrier. While the examiner notes that one of ordinary skill in the art would determine that said walls are fluid impermeable, as they function as the exterior structure of the device and thus allowing fluid through said walls would cause the function of the device to fail, however, the examiner brings in Cheng to specifically teach this limitation.
Cheng teaches a urine collection device and is thus considered analogous to the claimed invention. Cheng teaches that such devices known in the art comprise a wicking material for collecting fluid (wicking material 237, figure 3b), where the device further comprises an outermost layer that is impervious to fluid to prevent leaking (outer impervious layer (236), see para. 0114, see also para. 0028 where impervious layer surrounds the intake layer). As such, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the outer walls of Ecklund to be fluid impervious to prevent leakage of fluid out of the device. Doing so would yield the predictable result of providing a urine collection device that would prevent leakage out of the outmost layer of the device.
The examiner notes that per the amendments filed 06/04/2026, claim 1 further requires that the fluid impermeable barrier is “secured to substantially all of the proximal edge and the two side edgers of the fluid permeable body…with one or more of an adhesive, a press fit, a molding, or a combination thereof, the fluid impermeable barrier covering and abutting substantially all of the first side”. The examiner notes that as detailed above under the same rejection, the fluid impermeable barrier is understood to cover and abut substantially all of the first side. While there is no specific disclosure that the impermeable barrier of Ecklund is secured to the fluid permeable body by an adhesive (or other means), Ecklund does disclose that, in a separate embodiment, sheets forming the external fluid collection device may be coupled to each other by heat sealing means.
Cheng, previously combined, teaches that the outer pervious walls are sealed together by thermal or adhesive bonds (para. 0214). Therefore, as Cheng teaches that thermal bonds or adhesive bonds are suitable to connect layers of a fluid collection device together, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use an adhesive bond in place of the thermal bond taught by Ecklund, to secure the layers together. Doing so would merely require the simple substitution of one known element for another to obtain predictable results, that being the sealing of layer together, and thus a prima facie case of obviousness exists.
Should applicant argue that even upon combination, the outer layers are not specifically secured to the fluid permeable body, the examiner further relies on Krishnaswamy-Mirle.
Krishnaswamy-Mirle teaches an absorbent article and is thus considered analogous to the claimed invention. Krishnaswamy-Mirle teaches that suitably, “the outer cover may be secured to the absorbent barrier structure by a uniform continuous layer of adhesive (column 21, lines 10-26), where said “combined structure” provides the desired balance of properties including absorbency, barrier property, and convective air permeability (column 21, lines 27-33), the latter of which leads to lower humidity and reduction of irritation (column 21, lines 35-44). Therefore, as Krishnaswamy-Mirle teaches that an outer cover and absorbent core may suitably be attached to one another through an adhesive and provide desirable effects including lowering of humidity and irritation, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to further secure the outer cover to the article of Ecklund to the absorbent to attain a further reduction in humidity and irritation. Doing so would merely require the use of known technique to improve similar devices (methods, or products) in the same way, and thus a prima facie case of obviousness exists.
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Regarding claim 15, Ecklund, Cheng, and Krishnaswamy-Mirle teach the method of claim 14, further comprising inserting a penis through an opening in a bottom portion of the fluid impermeable barrier. As detailed under the rejection of claim 14, the penis is inserted through aperture 1624. As seen in figure 16A said aperture is at the bottom of the device. Further, opening 1638 in figure 16C is also interpreted to be on the bottom of the device as this is the patient facing side.
Regarding claim 16, Ecklund, Cheng, and Krishnaswamy-Mirle teach the method of claim 15, wherein inserting a penis through an opening in a bottom portion of the fluid impermeable barrier includes inserting the penis through the opening in the bottom portion of the fluid impermeable barrier, a portion of the fluid impermeable barrier covering an edge of the fluid permeable body at least partially surrounding the opening such that the penis is positioned between a top portion of the fluid impermeable barrier and the portion of the fluid impermeable barrier covering the edge of the fluid permeable body at least partially surrounding the opening. . As detailed under the rejection of claim 15, the penis is inserted through aperture 1624 of Ecklund . As seen in Ecklund figure 16A said aperture is at the bottom of the device. Further per the rejection of claim 14, the impermeable barrier is defined as Ecklund 1690A and 1690B which join to make the entire chamber. As such it is interpreted that at least a portion of the barrier covering the edge of the permeable body at least partially surrounds the opening such that the penis is positioned between a top portion of the fluid impermeable barrier (1690A) at least surround the opening, since the opening is located within the outer perimeter of the impermeable portion (1690B), and the top portion (1690A) combines with the bottom portion (1690B) to form the chamber for the penis and collection of urine. Thus, the entire impermeable barrier perimeter surrounds the opening. As such the prior art reads to the claimed limitation.
Regarding claim 18, Ecklund, Cheng, and Krishnaswamy-Mirle teach the method of claim 14,wherein the fluid permeable body includes a fluid permeable porous fiber structure (para. 0190, where the permeable layer 1690D can be a natural or synthetic fiber layer with a moisture transfer channel through the layer [thus interpreted to be porous]) and an outer fluid permeable wicking material (Ecklund wicking layer 1690E, interpreted to be an outer layer since said layer forms at least an outer layer of the fluid permeable barrier [see second side per the annotated figure under the rejection of claim 14).
Regarding claim 19, Ecklund, Cheng, and Krishnaswamy-Mirle teach the urine collection device of claim 1, wherein the fluid impermeable barrier is secured to substantially all of the proximal edge and the two side edges with an adhesive. The examiner notes that as detailed under the rejection of claim 1, an adhesive is used to attached the barrier to the fluid permeable layer.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ecklund in view of Cheng and Krishnaswamy-Mirle, and further in view of Harvie US 2003/0163120, hereafter Harvie.
Regarding claim 20, Ecklund, Cheng, and Krishnaswamy-Mirle teach the urine collection device of claim 1, wherein the aperture is positioned at a distal end region of the fluid impermeable barrier and the tube extends outside the chamber from the aperture at least partially towards a proximal end region of the fluid impermeable barrier. The examiner notes that as detailed under the rejection of claim 1, the seam (1699), allowing the external tubing into the collection device is interpreted as the aperture. Said aperture, seen in figure 16b, is at the distal end. While the tubing extends outside the barrier through the aperture, the tubing is not specifically disclosed to extend toward a proximal region of the barrier.
Harvie teaches am external urine collection device and is thus considered analogous to the claimed invention. Harvie teaches that the device comprises a suction hose (13) seen in figure 4, to extend out from an aperture located at a distal end of a male urine collection device. Per para. 0077, the suction hose may be made of a convoluted, easily bendable material allowing for a bending radius such that the hose can be stored in clothing, while allowing urine to be drained. Said device is also useable for bedridden users (para. 0082). As seen in the figures, namely 4 and 5, but also figure 2, the flexible tubing allows the external tube to extend upwards and thus toward a proximal end of the device. Therefore, as Harvie teaches that a flexible tubing is suitably used in urine collection devices to aid in adjustment or hiding of the tubing in use, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a flexible tubing as the tubing of the device of Ecklund. Doing so would merely require the simple substitution of one known element for another to obtain predictable results, that being the drainage of fluid through the tubing, and thus a prima face case of obviousness exists. The examiner notes that in use, as seen in Harvie, the tubing extends out of the distal end of the device and upward, toward a proximal end of the device and thus the tubing of the combination of arts reads to the claimed invention.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ecklund in view of Cheng, and Harvie.
Regarding claim 21, Ecklund discloses a urine collection device (abstract, figure 16a), comprising: tube (1679) having an inlet (portion attached to 1694); a fluid permeable body (permeable layer 1690D and wicking layer 1690E, where, in construction the male member is placed adjacent said layers [para. 0188)) having a first side, a second side, a proximal edge, and two side edges extending from the proximal edge towards the inlet (the examiner notes that per para. 0188 as 1690D and 1690E form the fluid permeable barrier. It is interpreted that 1690E is the first side, 1690D is the second side, the proximal edge is the portion adjacent to the proximal edge of the device as a whole, and the two side edges are the perimeters of both 1690D and 1690E));
The examiner notes that while Ecklund discloses a fluid impermeable barrier (1690C) having a proximal end region and a distal end region (see annotated figure below), where said barrier is covering and interfacing substantially all of the first side, the proximal edge, and the two side edges of the fluid permeable body effective to prevent fluid communication into the fluid permeable body through the first side, the proximal edge, and the two side edges of the fluid permeable body (seen covering the defined first side and therefore at least a portion of the proximal and side edges), the examiner instead interprets the walls 1690A and 1690B as the fluid impermeable barrier. As seen in construction, figure 16B and 16C, show that said walls form the exterior barrier of the device, and thus cover the entire permeable barrier. While the examiner notes that one of ordinary skill in the art would determine that said walls are fluid impermeable, as they function as the exterior structure of the device and thus allowing fluid through said walls would cause the function of the device to fail, however, the examiner brings in Cheng to specifically teach this limitation.
Cheng teaches a urine collection device and is thus considered analogous to the claimed invention. Cheng teaches that such devices known in the art comprise a wicking material for collecting fluid (wicking material 237, figure 3b), where the device further comprises an outermost layer that is impervious to fluid to prevent leaking (outer impervious layer (236), see para. 0114, see also para. 0028 where impervious layer surrounds the intake layer). As such, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the outer walls of Ecklund to be fluid impervious to prevent leakage of fluid out of the device. Doing so would yield the predictable result of providing a urine collection device that would prevent leakage out of the outmost layer of the device.
The examiner further notes the Ecklund (in view of Cheng) teaches wherein the fluid impermeable barrier (outer wall formed by 1690A and 1690B) defines an aperture proximate to the distal region providing fluid communication between the fluid permeable body and at least a portion of the tube (seam 1699, see para. 0193, where said seam in the collection device allows the tube to extend through into the device); and a chamber sized to receive at least a portion of a penis therein to position a portion of the penis adjacent to a portion of the fluid permeable body (internal cavity 1638, see figure 16C). While the tubing extends outside the barrier through the aperture, the tubing is not specifically disclosed to extend toward a proximal region of the barrier.
Harvie teaches am external urine collection device and is thus considered analogous to the claimed invention. Harvie teaches that the device comprises a suction hose (13) seen in figure 4, to extend out from an aperture located at a distal end of a male urine collection device. Per para. 0077, the suction hose may be made of a convoluted, easily bendable material allowing for a bending radius such that the hose can be stored in clothing, while allowing urine to be drained. Said device is also useable for bedridden users (para. 0082). As seen in the figures, namely 4 and 5, but also figure 2, the flexible tubing allows the external tube to extend upwards and thus toward a proximal end of the device. Therefore, as Harvie teaches that a flexible tubing is suitably used in urine collection devices to aid in adjustment or hiding of the tubing in use, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a flexible tubing as the tubing of the device of Ecklund. Doing so would merely require the simple substitution of one known element for another to obtain predictable results, that being the drainage of fluid through the tubing, and thus a prima face case of obviousness exists. The examiner notes that in use, as seen in Harvie, the tubing extends out of the distal end of the device and upward, toward a proximal end of the device and thus the tubing of the combination of arts reads to the claimed invention.
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Claim(s) 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ecklund in view of Cheng, Harvie, and Krishnaswamy-Mirle.
Regarding claim 22, Ecklund, Cheng, and Harvie teach the urine collection device of claim 21, but fails to specifically teach wherein the fluid impermeable barrier is secured to substantially all of the proximal edge and the two side edges of the fluid permeable body with the fluid impermeable barrier covering and abutting substantially all of the first side, the proximal edge, and the two side edges of the fluid permeable body effective to prevent fluid communication into the fluid permeable body through the first side, the proximal edge, and the two side edges of the fluid permeable body.
The examiner notes that as detailed above under the rejection of claim 21, the fluid impermeable barrier is understood to cover and abut substantially all of the first side. While there is no specific disclosure that the impermeable barrier of Ecklund is secured to the fluid permeable body by an adhesive (or other means), Ecklund does disclose that, in a separate embodiment, sheets forming the external fluid collection device may be coupled to each other by heat sealing means.
Cheng, previously combined, teaches that the outer pervious walls are sealed together by thermal or adhesive bonds (para. 0214). Therefore, as Cheng teaches that thermal bonds or adhesive bonds are suitable to connect layers of a fluid collection device together, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use an adhesive bond in place of the thermal bond taught by Ecklund, to secure the layers together. Doing so would merely require the simple substitution of one known element for another to obtain predictable results, that being the sealing of layer together, and thus a prima facie case of obviousness exists.
Should applicant argue that even upon combination, the outer layers are not specifically secured to the fluid permeable body, the examiner further relies on Krishnaswamy-Mirle.
Krishnaswamy-Mirle teaches an absorbent article and is thus considered analogous to the claimed invention. Krishnaswamy-Mirle teaches that suitably, “the outer cover may be secured to the absorbent barrier structure by a uniform continuous layer of adhesive (column 21, lines 10-26), where said “combined structure” provides the desired balance of properties including absorbency, barrier property, and convective air permeability (column 21, lines 27-33), the latter of which leads to lower humidity and reduction of irritation (column 21, lines 35-44). Therefore, as Krishnaswamy-Mirle teaches that an outer cover and absorbent core may suitably be attached to one another through an adhesive and provide desirable effects including lowering of humidity and irritation, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to further secure the outer cover to the article of Ecklund to the absorbent to attain a further reduction in humidity and irritation. Doing so would merely require the use of known technique to improve similar devices (methods, or products) in the same way, and thus a prima facie case of obviousness exists.
Regarding claim 23, Ecklund, Cheng, Harvie, and Krishnaswamy-Mirle teach the urine collection device of claim 22, wherein the fluid impermeable barrier is secured to substantially all of the proximal edge and the two side edges with one or more of an adhesive, a press fit, a molding, or a combination thereof. The examiner notes that as detailed under the rejection of claim 22, the prior art device comprises the barrier secured to the absorbent within by means of an adhesive and thus reads to the claimed limitation.
Regarding claim 24, Ecklund, Cheng, Harvie, and Krishnaswamy-Mirle teach the urine collection device of claim 22, wherein the fluid impermeable barrier is secured to substantially all of the proximal edge and the two side edges with an adhesive. The examiner notes that as detailed under the rejection of claim 22, the prior art device comprises the barrier secured to the absorbent within by means of an adhesive and thus reads to the claimed limitation.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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