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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Application claims 1 and 4-5 are rejected under the judicially created doctrine of obviousness-type double patenting as unpatentable over claims 4 and 6 of U.S. Patent No. 11,523,933.
Regarding application claim 1, in the patent, claim 4 is dependent on claim 1. For double patenting to exist between application claim 1 and patent claim 4, it must be determined that the application claim is not patentably distinct from patent claim 4. In order to make this determination, it first must be determined whether there are any differences between the application claim and claim 4 and, if so, whether those differences render the claims patentably distinct.
Patent claim 1 recites all of the elements of application claim 1, except for the first attachment member comprising a first adhesive that is configured to couple the first attachment member to a user. Patent claim 4 recites that the first attachment member comprises a first adhesive that is configured to couple the first attachment member to a user. Patent claims 1 and 4 further recite additional elements not present in application claim 1.
It is clear that all the elements of application claim 1 are to be found in patent claim 4. The difference between application claim 1 and patent claim 4 lies in the fact that the patent claim includes many more elements and is thus more specific. Thus, the invention of patent claim 4 is in effect a “species” of the “generic” invention of application claim 1. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claim 1 is anticipated by patent claim 4, it is not patentably distinct from patent claim 4.
Regarding application claim 4, patent claim 4 further recites the subject matter of application claim 4, which is dependent on application claim 1. Therefore, application claim 4 is not patentably distinct from patent claim 4.
Regarding application claim 5, patent claim 6, which is dependent on patent claim 4, further recites the subject matter of application claim 5, which is dependent on application claim 1. Therefore, application claim 5 is not patentably distinct from patent claim 6.
Application claim 1 and 4-5 are rejected under the judicially created doctrine of obviousness-type double patenting as unpatentable over claims 4 and 6 of U.S. Patent No. 12,090,083.
Regarding application claim 1, in the patent, claim 4 is dependent on claim 1. For double patenting to exist between application claim 1 and patent claim 4, it must be determined that the application claim is not patentably distinct from patent claim 4. In order to make this determination, it first must be determined whether there are any differences between the application claim and claim 4 and, if so, whether those differences render the claims patentably distinct.
Patent claim 1 recites all of the elements of application claim 1, except for the first attachment member comprising a first adhesive that is configured to couple the first attachment member to a user. Patent claim 4 recites that the first attachment member comprises a first adhesive that is configured to couple the first attachment member to a user. Patent claims 1 and 4 further recite additional elements not present in application claim 1.
It is clear that all the elements of application claim 1 are to be found in patent claim 4. The difference between application claim 1 and patent claim 4 lies in the fact that the patent claim includes many more elements and is thus more specific. Thus, the invention of patent claim 4 is in effect a “species” of the “generic” invention of application claim 1. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claim 1 is anticipated by patent claim 4, it is not patentably distinct from patent claim 4.
Regarding application claim 4, patent claim 4 further recites the subject matter of application claim 4, which is dependent on application claim 1. Therefore, application claim 4 is not patentably distinct from patent claim 4.
Regarding application claim 5, patent claim 6, which is dependent on patent claim 4, further recites the subject matter of application claim 5, which is dependent on application claim 1. Therefore, application claim 5 is not patentably distinct from patent claim 6.
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.
Claims 1-3, 5, 12, 14-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa (US 5,735,837 A) in view of Bostick (US 4,197,849 A) and in further view of Fenton (US 3,881,486 A).
Regarding claim 1, Ishikawa discloses a urine collection device (Figs. 1-3, feat. 1; Col. 1, line 57 – Col. 2, line 6), comprising: a collection member extending from a proximal end to a distal end, wherein the collection member has a longitudinal axis that extends between the proximal end and the distal end (Fig. 1, feat. 1), wherein the proximal end comprises an opening that provides access to an internal cavity of the collection member (12; Col. 2, lines 7-20); a first attachment member (Figs. 1 and 3, feats. 15, 16, 20, 21; Col. 2, lines 7-20 and 35-59) on a bottom side of the collection member (Figs. 1-3, feat. 10; Col. 2, lines 7-20), wherein the first attachment member defines an aperture (Figs. 1 and 3, feat. 16), wherein the opening at the proximal end of the collection member has a center axis (Fig. 1, feat. 12) that is transverse to a center axis of the aperture defined by the first attachment member (Figs. 1 and 6, feat. 16).
Ishikawa does not disclose that the first attachment member comprises a first adhesive that is configured to couple the first attachment member to a user, a second attachment member on a top side of the collection member, an outlet for egressing urine from the internal cavity of the collection member, or that the collection member is suitable to direct urine distally toward the outlet.
Bostick teaches a urine collection device (Figs. 1-6C, feat. 10; Col. 2, line 27 – Col. 3, line 46) comprising a collection member (12; Col. 2, lines 27-55) comprising a bottom side (22) with an aperture (32) for receiving a patient’s penis (Col. 3, lines 8-46) and top side opposite the bottom side (38; Col. 2, lines 56-65). The bottom side (22) is provided with a first attachment member comprising an adhesive ring (24) surrounding the aperture (32; Col. 2, lines 46-55) for securing the device to the body of the patient (Col. 3, lines 8-26). Modifying the device of Ishikawa to include the adhesive ring of Bostick around the aperture of Ishikawa would allow the device to be secured to the body around the penis of a patient. The top side (38) comprises a second attachment member (42) which seals an opening (40) that provides access to the interior of the bag (Col. 2, lines 56-65; Col. 3, lines 26-46). Modifying the device of Ishikawa to include the second attachment member of Bostick would allow the opening in the proximal end of the collection member to be sealed like the opening of Bostick. Bostick teaches that such features allow the device to be secured to the patient for long periods of time without leakage (Col. 3, lines 30-41). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device disclosed by Ishikawa so that the first attachment member comprises a first adhesive that is configured to couple the first attachment member to a user, and the device comprises a second attachment member on a top side of the collection member in order to allow the device to be secured to the patient for long periods of time without leakage as taught by Bostick.
Ishikawa in view of Bostick does not suggest that the device comprises an outlet for egressing urine from the internal cavity of the collection member or that the collection member is suitable to direct urine distally toward the outlet.
Fenton teaches a drainage collection pouch (Fig. 1, feat. 10; Col. 2, lines 3-14) comprising a drainage outlet (21; Col. 2, lines 28-52) for removing excess fluid drainage from a collection pouch or member (Col. 1, lines 5-56). The collection pouch or member directs fluid towards the outlet (Col. 1, lines 50-56). Fenton teaches that such a drainage outlet advantageously eliminates the need for patients to get up during the night to empty the drainage collection pouch (Col. 1, lines 5-56). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Ishikawa in view of Bostick so that the device comprises an outlet for egressing urine from the internal cavity of the collection member and so that the collection member is suitable to direct urine distally toward the outlet in order to remove excess fluid drainage and eliminate the need for patients to get up during the night to empty the collection member as taught by Fenton.
Regarding claim 2, Ishikawa in view of Bostick and in further view of Fenton suggests the device of claim 1, and Ishikawa further discloses that the first attachment member (Figs. 1 and 3, feats. 15, 16, 20, 21) comprises a first flexible member (20) and a second flexible member (21) are movable relative to each other to facilitate access to the aperture (16) in the first attachment member (Fig. 1, feats. X, Y; Col. 2, lines 35-59). Regarding claim 3, Ishikawa further suggest that the first flexible member (20) is separated from the second flexible member (21) by a slit (15) extending proximally from the aperture (16) in the first attachment member.
Regarding claim 5, Ishikawa in view of Bostick and in further view of Fenton suggests the device of claim 1. As discussed above, Bostick teaches an adhesive ring (Figs. 1 and 5, feat. 24) extending around the aperture (32). Therefore, Ishikawa in view of Bostick and in further view of Fenton further suggests that the first adhesive extends around the aperture in the first attachment member.
Regarding claim 12, Ishikawa in view of Bostick and in further view of Fenton suggests the device of claim 1. Bostick teaches, and therefore Ishikawa in view of Bostick and in further view of Fenton suggests, an aperture (Figs. 1 and 5, feat. 32) for receiving the user’s penis at a position which is coincident with the opening of the collection member (40; Col. 2, lines 27-65). Bostick teaches that the opening (40) provides access to the interior of the collection member (Col. 3, lines 18-46). The courts have held that claims which read on the prior art except for the position of a particular element are not patentable if shifting the position of the element would not modify the operation of the device. Please see MPEP §2144.04(VI)(C) with respect to In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In this case, shifting the opening of the collection member to be distal of the aperture as claimed would still provide access to the interior of the collection member, and would therefore not modify the operation of the device.
Regarding claim 14, Ishikawa discloses a urine collection device (Figs. 1-3, feat. 1; Col. 1, line 57 – Col. 2, line 6), comprising: a first sheet of material providing a top wall of a collection member (Figs. 1-3, feat. 11; Col. 2, lines 7-20); a second sheet of material providing a bottom wall of the collection member (Figs. 1-3, feat. 10; Col. 2, lines 7-20), wherein the first sheet of material and the second sheet of material are coupled to each at a first lateral side of the collection member and a second lateral side of the collection member (7; Col. 1, line 57 – Col. 2, line 20), wherein the collection member has a longitudinal axis that extends between a proximal end and a distal end of the collection member (Fig. 1), an opening between the first sheet of material and the second sheet of material at the proximal end of the collection member, wherein the opening provides access to an internal cavity of the collection member (12; Col. 2, lines 7-20); a first attachment member provided by the first sheet of material and integral with the bottom wall of the collection member (Figs. 1 and 3, feats. 10, 11, 15, 16, 20, and 21; Col. 1, line 57 – Col. 2, line 20: first sheet providing top wall 11 and second sheet providing bottom wall 10 are the same laminate folded over at 6, and therefore first attachment member 15/16/20/21 integral with bottom wall 10 is also provide by top wall 11), wherein the first attachment member defines an aperture (Figs. 1 and 3, feat. 16), and wherein the opening at the proximal end of the collection member has a center axis (Fig. 1, feat. 12) that is transverse to a center axis of the aperture defined by the first attachment member (Figs. 1 and 6, feat. 16)
Ishikawa does not disclose a second attachment member provided by the second sheet of material and integral with the top wall of the collection member, an outlet for egressing urine from the internal cavity of the collection member, or that the collection member is suitable to direct urine distally toward the outlet.
Bostick teaches a urine collection device (Figs. 1-6C, feat. 10; Col. 2, line 27 – Col. 3, line 46) comprising a collection member (12; Col. 2, lines 27-55) comprising a bottom wall (22) with an aperture (32) for receiving a patient’s penis (Col. 3, lines 8-46) and top wall opposite the bottom wall (38; Col. 2, lines 56-65). The bottom wall (22) is provided with a first attachment member comprising an adhesive ring (24) surrounding the aperture (32; Col. 2, lines 46-55) for securing the device to the body of the patient (Col. 3, lines 8-26). The top wall (38) comprises a second attachment member (42) which seals an opening (40) that provides access to the interior of the bag (Col. 2, lines 56-65; Col. 3, lines 26-46). Modifying the device of Ishikawa to include the second attachment member of Bostick would allow the opening in the proximal end of the collection member to be sealed like the opening of Bostick, and because the first sheet providing the top wall of Ishikawa and the second sheet providing the bottom wall of Ishikawa are the same laminate folded over, the second attachment member of the modified device would be provided by the second sheet and integral with the top wall. Bostick teaches that such features allow the device to be secured to the patient for long periods of time without leakage (Col. 3, lines 30-41). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device disclosed by Ishikawa so that the device comprises a second attachment member provided by the second sheet of material and integral with the top wall of the collection member in order to allow the device to be secured to the patient for long periods of time without leakage as taught by Bostick.
Ishikawa in view of Bostick does not suggest that the device comprises an outlet for egressing urine from the internal cavity of the collection member or that the collection member is suitable to direct urine distally toward the outlet.
Fenton teaches a drainage collection pouch (Fig. 1, feat. 10; Col. 2, lines 3-14) comprising a drainage outlet (21; Col. 2, lines 28-52) for removing excess fluid drainage from a collection pouch or member (Col. 1, lines 5-56). The collection pouch or member directs fluid towards the outlet (Col. 1, lines 50-56). Fenton teaches that such a drainage outlet advantageously eliminates the need for patients to get up during the night to empty the drainage collection pouch (Col. 1, lines 5-56). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Ishikawa in view of Bostick so that the device comprises an outlet for egressing urine from the internal cavity of the collection member and so that the collection member is suitable to direct urine distally toward the outlet in order to remove excess fluid drainage and eliminate the need for patients to get up during the night to empty the collection member as taught by Fenton.
Regarding claim 15, Ishikawa in view of Bostick and in further view of Fenton suggests the device of claim 14, and Ishikawa further discloses that the first attachment member (Figs. 1 and 3, feats. 15, 16, 20, 21) comprises a first flexible member (20) and a second flexible member (21) are movable relative to each other to facilitate access to the aperture (16) in the first attachment member (Fig. 1, feats. X, Y; Col. 2, lines 35-59) and wherein the first flexible member (20) is separated from the second flexible member (21) by a slit (15) extending proximally from the aperture (16) in the first attachment member.
Regarding claim 18, Ishikawa in view of Bostick and in further view of Fenton suggests the device of claim 14. Bostick teaches, and therefore Ishikawa in view of Bostick and in further view of Fenton suggests, an aperture (Figs. 1 and 5, feat. 32) for receiving the user’s penis at a position which is coincident with the opening of the collection member (40; Col. 2, lines 27-65). Bostick teaches that the opening (40) provides access to the interior of the collection member (Col. 3, lines 18-46). The courts have held that claims which read on the prior art except for the position of a particular element are not patentable if shifting the position of the element would not modify the operation of the device. Please see MPEP §2144.04(VI)(C) with respect to In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In this case, shifting the opening of the collection member to be distal of the aperture as claimed would still provide access to the interior of the collection member, and would therefore not modify the operation of the device.
Claims 4 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa in view of Bostick, in further view of Fenton, and in further view of Gell et al. (US 2002/0193766 A1).
Regarding claim 4, Ishikawa in view of Bostick and in further view of Fenton suggests the device of claim 1, but does not disclose that the second attachment member comprises a second adhesive that is configured to couple the second attachment to the user.
Gell teaches a sanitary napkin (Abstract). Gell teaches an embodiment in which the sanitary napkin comprises one or more body adhesive attachment members (Figs. 6-8, feats. 10 and 20; ¶0064) on the anterior side of the napkin. The second attachment member taught by Bostick (Bostick: Figs. 1-6C, feat. 42), and therefore the second attachment member of the device suggested by Ishikawa in view of Bostick and in further view of Fenton, is similarly on the anterior side of the device. Gell teaches that securing the napkin to the body using such an attachment member allows the napkin to be anchored to the body in such a way that it can move with the body and have a dynamic fit (¶0063-0064). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Ishikawa in view of Bostick and in further view of Fenton so that the second attachment member comprises a second adhesive that is configured to couple the second attachment to the user in order to assist in securing the device to the use and provide a dynamic fit as taught by Gell.
Regarding claim 20, Ishikawa in view of Bostick and in further view of Fenton suggests the device of claim 14, but does not disclose that the second attachment member further comprises a center portion that is coupled to the first sheet of material, a first arm that extends in a first lateral direction from the center portion, and a second arm that extends in a second lateral direction from the center portion, and wherein the second attachment member comprises an adhesive on the first arm and the second arm.
Gell teaches a sanitary napkin (Abstract). Gell teaches an embodiment in which the sanitary napkin comprises one or more body adhesive attachment members (Figs. 6-8, feats. 10 and 20; ¶0064) on the anterior side of the napkin. The second attachment member taught by Bostick (Bostick: Figs. 1-6C, feat. 42), and therefore the second attachment member of the device suggested by Ishikawa in view of Bostick and in further view of Fenton, is similarly on the anterior side of the device. In one embodiment, the body adhesive attachment members comprises two arms which extend partially laterally away from a central point (Fig. 8, feat. 10). Gell teaches that securing the napkin to the body using such an attachment member allows the napkin to be anchored to the body in such a way that it can move with the body and have a dynamic fit (¶0063-0064). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Ishikawa in view of Bostick and in further view of Fenton so that the second attachment member further comprises a center portion that is coupled to the first sheet of material, a first arm that extends in a first lateral direction from the center portion, and a second arm that extends in a second lateral direction from the center portion, and wherein the second attachment member comprises an adhesive on the first arm and the second arm in order to assist in securing the device to the use and provide a dynamic fit as taught by Gell.
Claims 6-11 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa in view of Bostick, in further view of Fenton, and in further view of Harvie (US 2003/0163120 A1).
Regarding claim 6, Ishikawa in view of Bostick and in further view of Fenton suggests the device of claim 1. Ishikawa further discloses that the inner cavity is separated into an empty first chamber between permeable sheets (Fig. 2, feat. 2) and a second chamber with a liquid absorbent core (Fig. 2, feat. 4; Col. 1, line 57 – Col. 2, line 6). However, Ishikawa in view of Bostick and in further view of Fenton does not disclose a wicking layer separating the internal cavity into a first chamber and a second chamber, wherein the wicking layer is configured to move the urine from the first chamber toward the second chamber.
Harvie teaches a urine collection device (Figs. 4-5, feat. 57; ¶0075) comprising a fluid permeable facing layer (39M), a wicking layer (41M), an absorbent urine collection layer (43M), and a moisture proof outer layer (45M). The facing (39M) and wicking layers (41M) separate the internal cavity of the device into a first chamber for receiving the penis of a user and a urine chamber (56) defined by the urine collection layer (43M; ¶0075). The wicking layer (41M) pulls fluid away from the facing layer (39M), directs it toward the urine collection layer (43M), and advantageously prevents it from returning to the facing layer (¶0075). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Ishikawa in view of Bostick and in further view of Fenton so that it includes a wicking layer separating the internal cavity into a first chamber and a second chamber, wherein the wicking layer is configured to move the urine from the first chamber toward the second chamber in order to prevent urine from returning to the first chamber as taught by Harvie.
Regarding claim 7, Ishikawa in view of Bostick, in further view of Fenton, and in further view of Harvie suggests the device of claim 6. As discussed above, Harvie teaches a fluid permeable facing layer (39M) above the wicking layer (41M). Therefore, Ishikawa in view of Bostick, in further view of Fenton, and in further view of Harvie further suggests a permeable layer above the wicking layer in the internal cavity of the collection member.
Regarding claim 8, Ishikawa in view of Bostick, in further view of Fenton, and in further view of Harvie suggests the device of claim 7. Harvie further teaches that the fluid permeable facing layer (39M) and wicking layer (41M) prevent the user’s penis from entering the second chamber defined by the absorbent urine collection layer (43M). Therefore, Ishikawa in view of Bostick, in further view of Fenton, and in further view of Harvie further suggests that the permeable layer and the wicking layer inhibit access to the second chamber from outside of the first chamber.
Regarding claim 9, Ishikawa in view of Bostick, in further view of Fenton, and in further view of Harvie suggests the device of claim 8. Ishikawa further teaches that the permeable layer (Figs. 1-2, feat. 2; Col. 1, line 57 – Col 2, line 6) extends proximally beyond the aperture (16). Because the first adhesive of the device suggested by Ishikawa in view of Bostick, in further view of Fenton, and in further view of Harvie is the adhesive ring around an aperture taught by Bostick, the permeable layer extends proximally beyond the first adhesive. Therefore, Ishikawa in view of Bostick, in further view of Fenton, and in further view of Harvie further suggests that a proximal-most portion of the permeable layer extends proximally of a portion of a first adhesive on the first attachment member.
Regarding claim 10, Ishikawa in view of Bostick, in further view of Fenton, and in further view of Harvie suggests the device of claim 8. As discussed above, Harvie further teaches an absorbent urine collection layer (43M) below the wicking layer (41M). Therefore, Ishikawa in view of Bostick, in further view of Fenton, and in further view of Harvie further suggests a spacer below the wicking layer in the internal cavity of the collection member.
Regarding claim 11, Ishikawa in view of Bostick and in further view of Fenton suggests the device of claim 1. Fenton further teaches that the outlet comprises a rigid tube (Figs. 1-3, feat. 27; Col. 2, lines 28-61) and a port (24) for receiving additional tubing (25) at a distalmost point of the collection pouch (20). Therefore, Ishikawa in view of Bostick and in further view of Fenton further suggests that the outlet comprises a tube and a port coupled to the tube, wherein the port is configured to couple to a drain tube, and wherein the outlet is at a distalmost point of the collection member. Ishikawa in view of Bostick and in further view of Fenton does not disclose that the drain tube is connected to a vacuum device.
As discussed above, Harvie teaches a urine collection device (Figs. 4-5, feat. 57; ¶0075) comprising a fluid permeable facing layer (39M), a wicking layer (41M), an absorbent urine collection layer (43M), and a moisture proof outer layer (45M). Harvie further teaches that the absorbent urine collection layer may be in fluid communication with suction tubing (13) of a vacuum device (1) in order to suck collected urine away from the body (¶0075). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Ishikawa in view of Bostick and in further view of Fenton so that the drain tube is connected to a vacuum device in order to suck collected urine away from the body as taught by Harvie.
Regarding claim 16, Ishikawa in view of Bostick and in further view of Fenton suggests the device of claim 14, but does not disclose a wicking layer separating the internal cavity and a permeable layer above the wicking layer in the internal cavity.
Harvie teaches a urine collection device (Figs. 4-5, feat. 57; ¶0075) comprising a fluid permeable facing layer (39M), a wicking layer (41M), an absorbent urine collection layer (43M), and a moisture proof outer layer (45M). The facing (39M) and wicking layers (41M) separate the internal cavity of the device into a first chamber for receiving the penis of a user and a urine chamber (56) defined by the urine collection layer (43M; ¶0075). The wicking layer (41M) pulls fluid away from the facing layer (39M), directs it toward the urine collection layer (43M), and advantageously prevents it from returning to the facing layer (¶0075). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Ishikawa in view of Bostick and in further view of Fenton so that it includes a wicking layer separating the internal cavity and a permeable layer above the wicking layer in the internal cavity in order to prevent urine from returning to the first chamber as taught by Harvie.
Regarding claim 17, Ishikawa in view of Bostick, in further view of Fenton, and in further view of Harvie suggests the device of claim 16. As discussed above, Harvie further teaches an absorbent urine collection layer (43M) below the wicking layer (41M). Therefore, Ishikawa in view of Bostick, in further view of Fenton, and in further view of Harvie further suggests a spacer below the wicking layer in the internal cavity of the collection member.
Claims 13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa in view of Bostick, in further view of Fenton, and in further view of Palumbo et al. (US 6,464,674 B1).
Regarding claim 13, Ishikawa in view of Bostick and in further view of Fenton suggests the device of claim 1, but does not disclose that the aperture is elongated along the longitudinal axis.
Palumbo teaches a urine management device (Fig. 1, feat. 10) comprising an aperture (21) such that the aperture is an ellipse which is longer along the longitudinal axis of the device (Col. 2, lines 13-30) in order to improve the ease of application to the user (Col. 8, lines 5-43). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Ishikawa in view of Bostick and in further view of Fenton so that the aperture is elongated along the longitudinal axis in order to improve the ease of application to the user as taught by Palumbo.
Regarding claim 19, Ishikawa in view of Bostick and in further view of Fenton suggests the device of claim 14, but does not disclose that the aperture is elongated along the longitudinal axis.
Palumbo teaches a urine management device (Fig. 1, feat. 10) comprising an aperture (21) such that the aperture is an ellipse which is longer along the longitudinal axis of the device (Col. 2, lines 13-30) in order to improve the ease of application to the user (Col. 8, lines 5-43). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Ishikawa in view of Bostick and in further view of Fenton so that the aperture is elongated along the longitudinal axis in order to improve the ease of application to the user as taught by Palumbo.
Conclusion
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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