DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim6, 16 objected to because of the following informalities: The examiner notes that the term "filled" is unclear. While the examiner understands the term and can apply BRI to understand the term filled, clarification would help to clarify the metes and bounds of the claim.
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 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the mesh layer" in claim 10. There is insufficient antecedent basis for this limitation in the claim. The examiner notes that claim 10 depends from claim 1. However, claim 1 does not disclose “a mesh layer”, rather claim 3 first introduces “a mesh layer”. Therefore “the mesh layer” of claim 10 lacks antecedent basis. The examiner notes that the claim is therefore interpreted to depend from claim 3, such that the mesh layer has sufficient antecedent basis. Claims 11-14 are rejection based on dependency from claim 10.
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) 1-3,5-8,10,15 is/are rejected under 35 U.S.C. 103 as being unpatentable over [Acosta US 2019/0314189, hereafter Acosta.
Regarding Claim 1, Acosta discloses
An external incontinence catheter device (fig. 1), comprising: a catheter sleeve (sheath 130, disclosed as the second sheath), the catheter sleeve including an insertion end (end closest to body) and a tapered end (end furthest from body, connecting to drain tube (150) seen to taper), the catheter sleeve having an internal cavity extending into the catheter sleeve and outwardly through the insertion end, the internal cavity being configured to receive a penile shaft of a user (Fig. 1, where the interior space of the disclosed second sheath is the internal cavity, where said cavity can be seen extending to the insertion end and receiving the penis). Acosta further discloses and a drainage tube (150) being attached to the tapered end (figure 1, para. 0051).
This embodiment of Acosta does not specifically disclose a flexible material enclosed within the catheter sleeve and defining a filling configured to absorb a fluid evacuated through the penile shaft, the flexible material being enclosed within the catheter sleeve between the internal cavity and a peripheral wall of the catheter sleeve, however Acosta does teach this limitation (para. 0084, and 0073); The examiner notes that per para. 0073 and 0084, the second sheath (0073), or device (0084) may comprise an absorbent material to minimize contact between the users skin (0083). Paragraph 0073 relates to the embodiment in figure 18, where para. 0074 and 0075 discloses that this embodiment (therefore including the absorbent) may be used with a drain tube. Therefore, as a means for preventing contact between the user and discharged urine, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the embodiment of figure 1 of Acosta with an absorbent. The examiner notes that the absorbent is interpreted as the flexible material configured to absorb fluid. Further said absorbent would be located within the sleeve, between the cavity and peripheral wall. As a result of said modification, Acosta further teaches the drainage tube being in fluid communication with the flexible material and being configured to drain the fluid out of the catheter sleeve (see obviousness rejection, para. 0073-0075).
Regarding Claim 2, Acosta discloses
The external incontinence catheter device of claim 1, wherein the catheter sleeve is tubular (Fig. 1, where device is seen to be tubular, see also abstract).
Regarding Claim 3, Acosta discloses
The external incontinence catheter device of claim 1, however in this embodiment it is not specifically disclosed that the catheter sleeve further comprising: a mesh layer surrounded by the peripheral wall, the internal cavity extending within the mesh layer.
However, Acosta teaches an embodiment which reads to the claimed limitation (para. 0078). Per para. 0078, figure 20 depicts an embodiment where the first sheath (interpreted to be functionally equivalent to the first sheath of the previous embodiment) may be extended and may be perforated or a net-like material to allow air flow to the user’s skin (para. 0078). Therefore as Acosta teaches that an extended configuration made from a net-like material is a suitable configuration for the device of figure 1, and that said configuration allows for air flow to the user, 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 embodiment of figure 1 of Acosta to have the first sheet be extended and made from a net-like material. As seen in figure 20, the first sheath is shown to have an inner open space the extends from and directly open to the defined internal cavity. Further, net-like is interpreted to be a mesh.
Regarding Claim 5, Acosta discloses
The external incontinence catheter device of claim 3, the tapered end further comprising: a collection area extending between the mesh layer and the peripheral wall (see figure 1, figure 20), the collection area being configured to draw a fluid away from the penile shaft and toward the tapered end (figure 1, para. 0083). The examiner notes that the area between the first sheath and the tubing is interpreted as the collection area as urine would flow through the first sheath directly into said collection area. Further, the examiner notes that as seen in figure 1, the collection area directly leads into the tubing for removal of urine from the device, therefore it is interpreted that the collection area moves fluid away from the user. Should applicant disagree with this interpretation, paragraph 0083 discloses that a hydrophobic coating may be applied to the tubular material (second sheath thus the edge of the collection area) in order to facilitate flow away from the user. Therefore it is interpreted that the collection area is configured to draw fluid away from the user.
Regarding Claim 7, Acosta discloses
The external incontinence catheter device of claim 5, wherein the drainage tube is in fluid communication with the collection area (Fig. 1). The examiner notes that as previously defined, the collection area is the portion of the second sheath between the outlet of the first sheath and the outlet of the device (where the outlet of the device is the portion connecting to the tube (50)). Therefore the drainage tube is in fluid connection with the collection area.
Regarding Claim 8, Acosta discloses
The external incontinence catheter device of claim 1, the drainage tube being configured to attach to and be in fluid communication with a collection canister (figure 1, bag 145).
Regarding Claim 10, Acosta discloses
The external incontinence catheter device of claim 1, however the embodiment used in claim 1 does not disclose the insertion end further comprising: a soft roll opening extending inwardly into the internal cavity, the soft roll opening extending through the peripheral wall and through the mesh layer, the soft roll opening being configured to receive the penile shaft, thereby housing the penile shaft within the internal cavity.
However, Acosta (fig. 3) teaches this limitation. As seen in figure 3, a different method of installing the device is used. Per figure 3, the device comprises a retaining ring (320), where said ring is slid over the penis (para. 0040). The examiner notes that as seen in figure 3, there are two sets of arrows. The first top most arrows are interpreted to show the overall motion of the device when it is being put on. The second set of arrows (closest to (320)) show a clockwise and counterclockwise motion, interpreted to indicated how the device is slid onto the user. This rotation movement is interpreted to be a roll. Further, as seen in figure 3, said ring and thus the roll is attached to both the outer second sheath and inner first sheath (thus extends through the peripheral wall and mesh layer. Acosta further disclose that sliding and rolling are both accepted methods of putting on the device (para. 0032). Therefore as Acosta teaches that a roll on retaining ring is an obvious variant for retaining the device on the user, 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 said roll ring as the retaining means of figure 1, as a matter of simple substitution.
Regarding Claim 15, Acosta discloses
An external incontinence catheter system (fig. 1), comprising: a collection canister (145); a removable external catheter device (fig. 1, para. 0035, where device is able to be removed/replaced), the removable external catheter device comprising: a catheter sleeve (sheath 130, disclosed as the second sheath), the catheter sleeve including an insertion end (end closest to body) and a tapered end (end furthest from body, connecting to drain tube (150) seen to taper), the catheter sleeve having an internal cavity extending into the catheter sleeve and outwardly through the insertion end, the internal cavity being configured to receive a penile shaft of a user (Fig. 1, where the interior space of the disclosed second sheath is the internal cavity, where said cavity can be seen extending to the insertion end and receiving the penis). Acosta further discloses and a drainage tube (150) being attached to the tapered end (figure 1, para. 0051).
This embodiment of Acosta does not specifically disclose a flexible material enclosed within the catheter sleeve and defining a filling configured to absorb a fluid evacuated through the penile shaft, the flexible material being enclosed within the catheter sleeve between the internal cavity and a peripheral wall of the catheter sleeve, however Acosta does teach this limitation (para. 0084, and 0073); The examiner notes that per para. 0073 and 0084, the second sheath (0073), or device (0084) may comprise an absorbent material to minimize contact between the users skin (0083). Paragraph 0073 relates to the embodiment in figure 18, where para. 0074 and 0075 discloses that this embodiment (therefore including the absorbent) may be used with a drain tube. Therefore, as a means for preventing contact between the user and discharged urine, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the embodiment of figure 1 of Acosta with an absorbent. The examiner notes that the absorbent is interpreted as the flexible material configured to absorb fluid. Further said absorbent would be located within the sleeve, between the cavity and peripheral wall. As a result of said modification, Acosta further teaches the drainage tube being in fluid communication with the flexible material and being configured to drain the fluid out of the catheter sleeve (see obviousness rejection, para. 0073-0075).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Acosta in view of Machida et al. US 2005/0033248, hereafter Machida.
Regarding Claim 4, Acosta discloses
The external incontinence catheter device of claim 3, however fails to disclose that the mesh layer being formed of a soft cloth material.
Machida teaches an external urine collection device and is thus considered analogous to the claimed invention. Machida teaches that the device as a means to minimize the users skin from rubbing on the fabric, a nonwoven cloth is chosen for the skin contacting component of the device (para. 0022). Further, said cloth comprises a mesh sheet that makes up a part of the surface (para. 0022). Therefore as Machida teaches that non-woven cloths comprising at least a portion of mesh are known in the art to be used as materials for skin contacting components of urine collection devices, 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 cloth material, while still incorporating the net like structure for breathability, for the material of the first sheath of Acosta.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Acosta in view of Dwork US 6113582, hereafter Dwork.
Regarding Claim 6, Acosta discloses
The external incontinence catheter device of claim 5, wherein the collection area is filled by the flexible material. The examiner notes that as detailed under the rejection of claim 1, Acosta teaches that the second sheath comprises an absorbent material, interpreted to be the flexible material, where the absorbent material is configured to absorb fluid and prevent contact of fluid with the user. The examiner notes that as the first sheath and thus the user empties into the collection area per the rejection of claims 3 and 5, and the absorbent is within the second sheath, the absorbent is understood to be in the defined collection area. Therefore it is interpreted that the absorbent fills at least a portion of the collection area. However, there is no indication that the absorbent completely fills the collection area.
Dwork teaches an external male catheter and is this considered analogous to the claimed invention. Dwork teaches a sheath wrap (figure 10), where figure 11 show the sheath portion being worn around the shaft of the user, and where said sheath portion opens into a chamber. Per column 8 lines 32-41 and as seen in figure 10, the chamber comprises an absorbent material, where the absorbent is seen to fill the chamber. Therefore, as Acosta teaches a collection chamber at least partially filled with an absorbent, and Dwork teaches that collection chambers for male external catheters may be fully filled with an absorbent, it would have been obvious to modify the absorbent of Acosta to fill the entire collection area, as such absorbents are known in the art.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Acosta in view of Lim US 3788324, hereafter Lim.
Regarding Claim 9, Acosta discloses
The external incontinence catheter device of claim 1, but fails to teach wherein the peripheral wall is formed of a durable, latex-free plastic material. The examiner notes that Acosta teaches that the peripheral wall (wall of the second sheath) is a tubular material, and is interpreted to be durable due to the device being worn by a user for extended periods of time (fig. 1, para. 0005), but does not disclose a specific material.
Lim teaches an external catheter and is thus considered analogous to the claimed invention. Lim teaches that said catheter comprises a tubular sheath constructed of a resilient rubber or plastic material (column 3, lines 21-30). Therefore, as it is known in the art to make external catheters out a tubular resilient (thus durable) material of rubber or plastic, 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 plastic tubular material for the tubular material of Acosta.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Acosta in view of Zimmerman EP 3949917, hereafter Zimmerman.
Regarding Claim 11, Acosta discloses
The external incontinence catheter device of claim 10, however fails to teach that the soft roll opening further comprises: a supplementary length of the peripheral wall, the supplementary length being rolled up around a circumference of the soft roll opening, the supplementary length being configured to expand a diameter of the soft roll opening to receive a testicle of the user.
Zimmerman teaches a urine collection device and is thus considered analogous to the claimed invention. Zimmerman teaches that the device includes a urinal condom for placement on a user, where said condom further comprises a looping strap. Said looping strap is configured to extend behind and fastened to the testicles such that the device is prevented from slipping and therefore leaking (page 2, lines 34-41, paragraph starting with “a urinal condom” lines page 5, lines 6-11, paragraph starting with “a urinal condom”). Further, per page 5, lines 12-13, the device is rolled on to attach. As such, it is interpreted that the roll (condom) has a supplemental length for securing the testicles in addition to the shaft. Therefore, as a means to further secure and attach a condom catheter to a user, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the roll catheter of Acosta with a supplemental length for extending around the testicles, as a means to further secure the roll catheter and prevent leakage.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Acosta in view of Pinlac US 2021/0121318, hereafter Pinlac.
Regarding Claim 12, Acosta discloses
The external incontinence catheter device of claim 10, but fails to disclose the device further comprising: an adhesive member being attached to the peripheral wall proximate the soft roll opening, the adhesive member being configured to secure the catheter sleeve in place when the soft roll opening has received the penile shaft.
The examiner notes that as seen in figure 6, an embodiment shows the retaining ring (620, interpreted to be substantially the same as retaining ring 320, as both are described as a “first retaining ring”) can be seen to be used in combination with a further retaining device, that being straps (660), see para. 0048. However, no adhesive is disclosed.
Pinlac discloses an external catheter and is thus considered analogous to the claimed invention. Pinlac discloses that as a means to secure the base of an external catheter to the skin of a user, an adhesive material is used (para. 0019, see figure 2). Pinlac further discloses that said adhesive (210) is covered with a backing material (220), where said backing material preserves the adhesive until ready for use, where said backing is then removed (para. 0020). Therefore, as Acosta teaches a roll on external urine collection device where said roll on further comprises a structure for securing, and Pinlac discloses that it is known in the art to use an adhesive to secure external catheters to the body of the user, 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 as the securement means of Acosta, as a matter of simple substitution of one known securing means for another. The examiner notes that the adhesive of the combination would be attached to the peripheral wall of Acosta, as that the is the outermost structure of Acosta. Further, the adhesive would be proximate the roll opening as the roll opening is where the penis is received and would thus be closest the body (See Pinlac figure 1, where penis receiving opening is adjacent to the adhesive.
Regarding Claim 13, Acosta and Pinlac teach
The external incontinence catheter device of claim 12, the adhesive member further comprising: a peel-off layer removably covering the adhesive member (Pinlac backing 220), the peel-off layer being configured to protect the adhesive member from degradation until the catheter sleeve is in place and the peel-off layer is removed to expose the adhesive member (para. 0020). The examiner notes that per the rejection of claim 12, Pinlac, found obvious to combine with Acosta, comprises a backing layer configured to preserve the adhesive until removed.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Acosta in view of Pinlac and further in view of Wendler US 5197957, hereafter Wendler.
Regarding Claim 14, Acosta and Pinlac teach
The external incontinence catheter device of claim 13, however fail to specifically teach wherein the peel- off layer is formed of paper, cloth, or other fibrous materials.
Wendler teaches a fluid collection device and is thus considered analogous to the claimed invention. Wendler teaches that it is known in the art to use a backing material to cover an adhesive for storage (column 4, lines 33-38). Wendler further teaches that said backing material may be in the form of a paper or film (column 4, lines 38-44). Therefore, as Wendler teaches that backings for adhesive are known in the art to be in the form of paper, 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 paper for the backing layer material of Acosta and Pinlac.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Acosta in view of Dwork, Machida, Lim, Zimmerman, and Pinlac.
Regarding Claim 16, Acosta discloses
An external male incontinence catheter device (fig. 1), comprising: a catheter sleeve (sheath 130, disclosed as the second sheath), the catheter sleeve having a tapered end (end furthest from body, connecting to drain tube (150) seen to taper) opposite an insertion end (end closest to body); the catheter sleeve being tubular (abstract).
In the embodiment of figure 1 it is not specifically disclosed that the catheter sleeve further comprising: a mesh layer surrounded by the peripheral wall, the internal cavity extending within the mesh layer.
However, Acosta teaches an embodiment which reads to the claimed limitation (para. 0078). Per para. 0078, figure 20 depicts an embodiment where the first sheath (interpreted to be functionally equivalent to the first sheath of the previous embodiment) may be extended and may be perforated or a net-like material to allow air flow to the user’s skin (para. 0078). Therefore as Acosta teaches that an extended configuration made from a net-like material is a suitable configuration for the device of figure 1, and that said configuration allows for air flow to the user, 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 embodiment of figure 1 of Acosta to have the first sheet be extended and made from a net-like material. As seen in figure 20, the first sheath is shown to have an inner open space the extends from and directly open to the defined internal cavity. Further, net-like is interpreted to be a mesh. It can be seen in figure 1, the outer sheath completely surrounds the inner mesh sheath and thus reads to the claimed limitation.
Acosta teaches an absorbent material enclosed within the catheter sleeve between the outer layer and the mesh layer; The examiner notes that per para. 0073 and 0084, the second sheath (0073), or device (0084) may comprise an absorbent material to minimize contact between the users skin (0083). Paragraph 0073 relates to the embodiment in figure 18, where para. 0074 and 0075 discloses that this embodiment (therefore including the absorbent) may be used with a drain tube. Therefore, as a means for preventing contact between the user and discharged urine, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the embodiment of figure 1 of Acosta with an absorbent. Further said absorbent would be located within the sleeve, between the cavity and peripheral wall. As a result of said modification, Acosta further teaches the drainage tube being in fluid communication with absorbent and being configured to drain the fluid out of the catheter sleeve (see obviousness rejection, para. 0073-0075).
The examiner notes that per the combination of embodiments, Acosta teaches that the tapered end having a collection area extending between the mesh layer and the outer layer (where the collection area is the previously defined under the same rejection as the interior space of the disclosed second sheath and where the first sheath is shown to have an inner open space the extends from and directly open to the defined internal cavity, per figure 20). Further, net-like is interpreted to be a mesh. It can be seen in figure 1, the outer sheath completely surrounds the inner mesh sheath and thus reads to the claimed limitation.
The examiner notes that as detailed under the same rejection of claim 16, Acosta teaches that the second sheath comprises an absorbent material, where the absorbent material is configured to absorb fluid and prevent contact of fluid with the user. The examiner notes that as the first sheath and thus the user empties into the collection area, and the absorbent is within the second sheath, the absorbent is understood to be in the defined collection area. Therefore it is interpreted that the absorbent fills at least a portion of the collection area. However, there is no indication that the absorbent completely fills the collection area.
Dwork teaches an external male catheter and is this considered analogous to the claimed invention. Dwork teaches a sheath wrap (figure 10), where figure 11 show the sheath portion being worn around the shaft of the user, and where said sheath portion opens into a chamber. Per column 8 lines 32-41 and as seen in figure 10, the chamber comprises an absorbent material, where the absorbent is seen to fill the chamber. Therefore, as Acosta teaches a collection chamber at least partially filled with an absorbent, and Dwork teaches that collection chambers for male external catheters may be fully filled with an absorbent, it would have been obvious to modify the absorbent of Acosta to fill the entire collection area, as such absorbents are known in the art.
Acosta further discloses the collection area being configured to draw a fluid away from the penile shaft and toward the tapered end. The examiner notes that the absorbent is configured to absorb fluid and prevent direct contact between the fluid and the user, as the absorbent is located toward to tapered end from the user, it is interpreted that the collection area is configured to draw fluid away from the user and toward the tapered end, thus preventing contact. Should applicant disagree with this interpretation, paragraph 0083 discloses that a hydrophobic coating may be applied to the tubular material (second sheath thus the edge of the collection area) in order to facilitate flow away from the user. Therefore it is interpreted that the collection area is configured to draw fluid away from the user.
Acosta further discloses a drainage tube being attached to the outer layer at the tapered end (drainage tube (150)), the drainage tube being in fluid communication with the collection area (where the tube can be seen connected to the tapered end, which is in fluid communication with the collection area), the drainage tube being configured to attach to and be in fluid communication with a collection canister (fig. 1, tube (150) attaching to container (145)), the drainage tube being configured to drain the fluid out of the collection area and to allow for suction of the fluid through the drainage tube into the collection canister (para. 0038, where the tube and device drain into bag (145)).
While the previously used embodiment of Acosta fails to teach the insertion end having a soft roll opening extending inwardly into the internal cavity, the soft roll opening extending through the outer layer and through the mesh layer, the soft roll opening being configured to receive a penile shaft of a user, thereby housing the penile shaft within the internal cavity, Acosta (fig. 3) teaches this limitation. As seen in figure 3, a different method of installing the device is used. Per figure 3, the device comprises a retaining ring (320), where said ring is slid over the penis (para. 0040). The examiner notes that as seen in figure 3, there are two sets of arrows. The first top most arrows are interpreted to show the overall motion of the device when it is being put on. The second set of arrows (closest to (320)) show a clockwise and counterclockwise motion, interpreted to indicated how the device is slid onto the user. This rotation movement is interpreted to be a roll. Further, as seen in figure 3, said ring and thus the roll is attached to both the outer second sheath and inner first sheath (thus extends through the peripheral wall and mesh layer. Acosta further disclose that sliding and rolling are both accepted methods of putting on the device (para. 0032). Therefore as Acosta teaches that a roll on retaining ring is an obvious variant for retaining the device on the user, 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 said roll ring as the retaining means of figure 1, as a matter of simple substitution.
Acosta fails to disclose that the mesh layer being formed of a soft cloth material.
Machida teaches an external urine collection device and is thus considered analogous to the claimed invention. Machida teaches that the device as a means to minimize the users skin from rubbing on the fabric, a nonwoven cloth is chosen for the skin contacting component of the device (para. 0022). Further, said cloth comprises a mesh sheet that makes up a part of the surface (para. 0022). Therefore as Machida teaches that non-woven cloths comprising at least a portion of mesh are known in the art to be used as materials for skin contacting components of urine collection devices, 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 cloth material, while still incorporating the net like structure for breathability, for the material of the first sheath of Acosta.
Acosta discloses that the peripheral wall (wall of the second sheath) is a tubular material, and is interpreted to be durable due to the device being worn by a user for extended periods of time (fig. 1, para. 0005), but does not disclose a specific material, thus failing to disclose the outer layer being formed of a durable, latex-free plastic material.
Lim teaches an external catheter and is thus considered analogous to the claimed invention. Lim teaches that said catheter comprises a tubular sheath constructed of a resilient rubber or plastic material (column 3, lines 21-30). Therefore, as it is known in the art to make external catheters out a tubular resilient (thus durable) material of rubber or plastic, 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 plastic tubular material for the tubular material of Acosta.
Acosta, alone or in combination with the previously applied prior arts fails to teach the soft roll opening having a supplementary length of the outer layer, the supplementary length being rolled up around a circumference of the soft roll opening, the supplementary length being configured to expand the soft roll opening to receive a testicle of the user;
Zimmerman teaches a urine collection device and is thus considered analogous to the claimed invention. Zimmerman teaches that the device includes a urinal condom for placement on a user, where said condom further comprises a looping strap. Said looping strap is configured to extend behind and fastened to the testicles such that the device is prevented from slipping and therefore leaking (page 2, lines 34-41, paragraph starting with “a urinal condom” lines page 5, lines 6-11, paragraph starting with “a urinal condom”). Further, per page 5, lines 12-13, the device is rolled on to attach. As such, it is interpreted that the roll (condom) has a supplemental length for securing the testicles in addition to the shaft. Therefore, as a means to further secure and attach a condom catheter to a user, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the roll catheter of Acosta with a supplemental length for extending around the testicles, as a means to further secure the roll catheter and prevent leakage.
Acosta, alone or in combination with the previous prior arts fails to teach an adhesive member being attached to the outer layer proximate the soft roll opening, the adhesive member being configured to secure the catheter sleeve in place when the soft roll opening has received the penile shaft.
The examiner notes that as seen in figure 6 of Acosta, an embodiment shows the retaining ring (620, interpreted to be substantially the same as retaining ring 320, as both are described as a “first retaining ring”) can be seen to be used in combination with a further retaining device, that being straps (660), see para. 0048. However, no adhesive is disclosed.
Pinlac discloses an external catheter and is thus considered analogous to the claimed invention. Pinlac discloses that as a means to secure the base of an external catheter to the skin of a user, an adhesive material is used (para. 0019, see figure 2). Pinlac further discloses that said adhesive (210) is covered with a backing material (220), where said backing material preserves the adhesive until ready for use, where said backing is then removed (para. 0020). Therefore, as Acosta teaches a roll on external urine collection device where said roll on further comprises a structure for securing, and Pinlac discloses that it is known in the art to use an adhesive to secure external catheters to the body of the user, 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 as the securement means of Acosta, as a matter of simple substitution of one known securing means for another. The examiner notes that the adhesive of the combination would be attached to the peripheral wall of Acosta, as that the is the outermost structure of Acosta. Further, the adhesive would be proximate the roll opening as the roll opening is where the penis is received and would thus be closest the body (See Pinlac figure 1, where penis receiving opening is adjacent to the adhesive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cheng 2004/0176731, Kharkar US 2022/0265461, Davis US 2018/0228642, all disclosing external catheter devices.
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 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781