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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/27/2026 has been entered.
Status of Claims
Claims 1-20 are pending and examined on the merits.
Claims 1-4, 6, 11, 13, 15-17, and 19 are currently amended.
Claim 20 is new.
Information Disclosure Statement
The six information disclosure statements (IDS’s) submitted on 01/27/2026, 03/18/2026, 05/07/2026, 06/24/2026, 07/01/2026, and 07/15/2026 were filed before the mailing date of the First Office Action on the merits. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Amendment
Applicant’s arguments filed 01/27/2026 have been fully considered.
Response to Arguments
Applicant’s arguments filed 01/27/2026 have been fully considered but they are unpersuasive.
Regarding the argument that the area labeled as a fluid compartment is not fluid tight in use (see page 8 of Remarks filed 01/27/2026), Examiner respectfully disagrees. Specifically, as stated on pages 2-3 of the Final Rejection mailed 10/27/2025, when a glans of a penis is inserted partially through the device, the “1st fluid compartment” of Schneider acts as a fluid compartment at least because an accidental discharge of urine would at least partially be contained within the “1st fluid compartment” of Schneider (see Figs. 2-3). Additionally, as broadly recited, when the glans of the penis is inserted partially through the device, this is considered to be in use. In addition, since the “1st fluid compartment” is described as being formed of latex (see col. 3, lines 34-35) i.e., of rubbery material that has flexibility and elasticity that conforms to anatomy, it is considered to be fluid tight. In addition, when the glans of the penis is inserted partially through the device, the aperture of the “1st fluid compartment” of Schneider is closed by the penis making the “1st fluid compartment” fluid tight in use (see at least Fig. 2).
Regarding the argument that the shape and construction of the urine receiving section would force the thin-film unidirectional fluid flow valve of Moss into an always-open position, or that a skill person would not be motivated to add a thin-film unidirectional valve (see pages 8-9 of Remarks filed 01/27/2026), Examiner respectfully disagrees. Specifically, a unidirectional fluid flow valve that permits fluid flow from the 1st to the 2nd compartment and that interferes with fluid reflux is beneficial at least because when a penis is inserted in the device, the valve would be open to allow urine to flow through the device, and when a penis is removed from the device, the valve would be closed to prevent urine from flowing back through the device. For example, a unidirectional valve placed on the inner sleeve 14 (see Fig. 1 of Schneider) would achieve that function (see also col. 1, lines 21-26 of Moss). In addition, the combination of the two materials of Schneider and Moss would not make the device not functional as the valve would still function even with a rigid outer shell.
Regarding the argument against the rejection of claim 4 (see page 9 of Remarks filed 01/27/2026) that Schneider does not teach the changing flow rate, Examiner respectfully disagrees. Specifically, as broadly recited, when a glans of the penis is partially inserted through the sheath section 11, fluid will flow through the sheath section 11 to the urine-receiving section 12 at a first flow rate, however, due to the shape of the inner sleeve 14, fluid will flow at a lower flow rate through the outlet conduit. For example, due to the diameter change of the urine-receiving section 12, fluid flow rate would be necessarily reduced as fluid flows through the urine-receiving section 12. Additionally/alternatively, due to the angled surface of the urine-receiving section 12 (see at least Fig. 1 of Schneider), flow changes due to turbulent flow from fluid hitting the angled surface of the urine-receiving section 12.
Regarding the argument that clamping section 25 cannot be characterized as a third fluid-tight compartment (see page 10 of Remarks filed 01/27/2026), Examiner respectfully disagrees. Specifically, Schneider teaches that the clamping member 25 forces the rim 34 of the cup-shaped portion 26 into tight sealing contact with bead 16 (see col. 5, lines 3-8 and Fig. 6). Therefore, a third fluid compartment that is fluid tight in use is formed between an inner surface of clamping member 25 and an outer surface of urine-receiving section 12.
In addition, the claims, as presently presented, do not require that the fluid compartment is configured to hold fluid during use. Therefore, the limitations are taught by the prior art references cited below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-7, 9-10, 12, 16-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (U.S. Patent No. 4,759,753 A) in view of Moss (U.S. Patent No. 3,405,714 A).
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Regarding claim 1, Schneider, with reference to Image 1 above, teaches: A urine removal device (see at least Abstract and col. 1, lines 53-59) comprising:
a flexible pouch (see Image 1; as broadly claimed, the pouch is considered to be the entire device shown in Image 1; col. 2, lines 7-10 teach that the sheath is stretchable and elastic) having a proximal end and a distal end (see Image 1);
an aperture (see Image 1) disposed on an external surface of the pouch (Id.), wherein the aperture is capable of receiving at least a part of a penis (see col. 3, lines 37-40); and
an outlet conduit affixed to the flexible pouch (see Image 1), the outlet conduit comprising a fluid inlet, a fluid outlet, and a lumen connecting the fluid inlet to the fluid outlet (col. 4, lines 22-25 teaches that the drainage tube is conventional and leads to a urine receiving receptacle; therefore, the drainage tube has an inlet, an outlet, and a lumen connecting the inlet to the outlet);
wherein:
the flexible pouch comprises a first fluid compartment (see Image 1; see also Fig. 5) that is fluid tight in use (see col. 2, lines 31-40; when a glans of a penis is inserted partially through the device, the 1st fluid compartment acts as a fluid compartment at least because an accidental discharge of urine would at least partially be contained within the 1st fluid compartment - see Figs. 2-3; additionally, as broadly recited, when the glans of the penis is inserted partially through the device, this is considered to be in use; in addition, col. 3, lines 34-35 describe the 1st fluid compartment as being formed of latex, therefore, it is considered to be fluid tight.), a second fluid compartment (see Image 1; see also Fig. 5) that is fluid tight in use (see col. 2, lines 31-40 teaching that the receiving section is formed of a plastic material, which is considered to be fluid tight) and a first fluid transmission passageway (see Image 1) interconnecting the first fluid compartment and the second fluid compartment (see Fig. 1; as shown in Fig. 5, and as broadly claimed, inner sleeve 14 interconnects the first fluid compartment and second fluid compartment when a penis is inserted into sheath section 11);
the aperture disposed on the external surface of the pouch is an aperture into the first fluid compartment (see Image 1);
the first fluid compartment is positioned closer to the proximal end of the pouch and further from the distal end of the pouch (see Image 1); and
the second fluid compartment is positioned closer to the distal end of the pouch and further from the proximal end of the pouch (see Image 1).
However, Schneider fails to explicitly teach that the first fluid transmission passageway comprises a unidirectional fluid flow valve that permits fluid flow to one fluid compartment in one direction and interferes with fluid reflux in the other direction, as required by the claim.
Moss teaches an analogous male external catheter (see col. 1, lines 8-9) comprising a pouch (see for example Figs. 1-4) having a first compartment (see “I” Fig. 3) and a second compartment (see “B” in Fig. 3) and a fluid transmission passageway (30 in Fig. 3) that comprises a unidirectional fluid flow valve (see col. 2, lines 57-65; additionally, col. 1, lines 21-26 teaches that the valve can be a simple flutter valve) that permits fluid flow from the first fluid compartment to the second fluid compartment and that interferes with fluid reflux from the second fluid compartment to the first fluid compartment (see col. 2, lines 57-65).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schneider to incorporate the teachings of Moss by including a first and transmission passageway at least in order to allow fluid flow into one compartment but prevent fluid flow into another compartment, as taught by Moss (see col. 2, lines 57-65; see also col. 1, lines 21-26). Additionally, one of ordinary skill in the art would have reasonably found the unidirectional fluid flow valve that permits fluid flow from the 1st to the 2nd compartment and that interferes with fluid reflux beneficial at least because when a penis is inserted in the device, the valve would be open to allow urine to flow through the device, and when a penis is removed from the device, the valve would be closed to prevent urine from flowing back through the device. For example, a unidirectional valve placed on the inner sleeve 14 (see Fig. 1 of Schneider) would achieve that function (see also col. 1, lines 21-26 of Moss).
Regarding claim 2, Schneider in view of Moss teaches the invention as discussed above in claim 1. Additionally, Schneider in view of Moss teaches wherein the unidirectional fluid flow valve is a flutter valve (see col. 1, lines 21-26 of Moss).
Regarding claim 3, Schneider in view of Moss teaches the invention as discussed above in claim 1. Additionally, Schneider in view of Moss teaches wherein the fluid inlet of the outlet conduit is located within the second fluid compartment (see Image 1) and the fluid outlet of the outlet conduit member is configured for coupling with a fluid collection receptacle (col. 4, lines 22-25 of Schneider teaches that the drainage tube is conventional and leads to a urine receiving receptacle; therefore, the drainage tube at least inherently configured to be coupled to a receptacle).
Regarding claim 4, Schneider in view of Moss teaches the invention as discussed above in claim 1. Additionally, Schneider in view of Moss teaches wherein:
the first fluid transmission passageway is sized to enable fluid flow from the first fluid compartment to the second fluid compartment at a first flow rate (at least inherent; see also Fig. 5 of Schneider showing the opening created by inserting a tip of a penis into sleeve 11 as larger in diameter than the conduit 23);
the outlet conduit member is sized to enable fluid flow out from the second fluid compartment at a second flow rate (at least inherent); and
the first flow rate is greater than the second flow rate (as described above, since the opening of the first fluid transmission passageway is larger in diameter than the outlet conduit member, the first fluid transmission passageway will have a greater first flow rate compared to the second flow rate of the outlet conduit member; additionally/conversely, when a glans of the penis is partially inserted through the sheath section 11, fluid will flow through the sheath section 11 to the urine-receiving section 12 at a first flow rate, however, due to the shape of the inner sleeve 14, fluid will flow at a lower flow rate through the outlet conduit; for example, due to the diameter change of the urine-receiving section 12, fluid flow rate would be necessarily reduced as fluid flows through the urine-receiving section 12; additionally/alternatively, due to the angled surface of the urine-receiving section 12 (see at least Fig. 1 of Schneider), flow changes due to turbulent flow from fluid hitting the angled surface of the urine-receiving section 12).
Regarding claim 6, Schneider in view of Moss teaches the invention as discussed above in claim 1. Additionally, Schneider in view of Moss teaches wherein the first fluid transmission passageway comprises a fluid passageway inlet and a fluid passageway outlet (see Image 1 of Schneider), each positioned between the aperture and the fluid inlet of the outlet conduit (Id.).
Regarding claim 7, Schneider in view of Moss teaches the invention as discussed above in claim 1. However, while the embodiment of Fig. 1 of Schneider fails to teach wherein external peripheral boundaries of the first fluid compartment are located partially or wholly within external peripheral boundaries of the second fluid compartment, as required by the claim, other embodiments in Schneider teach such a limitation (see for example Figs. 8 and 13). Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the design of the embodiment of Schneider in view of Moss to make the external peripheral boundaries of the first fluid compartment located partially or wholly within external peripheral boundaries of the second fluid compartment at least because such a configuration is taught in Schneider (see Figs. 8 and 13) and Schneider teaches that those skilled in the art would understand that the structural details of the invention can be varied (see col. 7, lines 39-44).
Regarding claims 9-10, Schneider in view of Moss teaches the invention as discussed above in claim 1. Additionally, Schneider in view of Moss teaches comprising a fold-resistant feature on the outlet conduit member (as applied to claim 9; see for example distal neck portion 27 in Fig. 5 of Schneider), wherein the fold-resistant feature is configured to resist the collapse of a lumen defined by the outlet conduit member (as broadly claimed, in Schneider the distal neck portion 27 prevents a proximal end of tube 23 from collapsing; additionally, distal neck portion 27 is configured to resist collapse); wherein the fold-resistant feature comprises one or more accordion pleats or bellows folds (as applied to claim 10; as seen in Figs. 5-6 of Schneider, distal neck portion 27 has features that provide for a rougher gripping surface; as broadly claimed, these features can be considered accordion pleats or bellows folds; additionally, col. 4, lines 29-30 teaches that the neck portion has an internally threaded bore 28, which, as broadly claimed, can be considered accordion pleats or bellows folds).
Regarding claim 12, Schneider in view of Moss teaches the invention as discussed above in claim 1. Additionally, Schneider in view of Moss teaches wherein the fluid inlet of the outlet conduit member is positioned between a fluid outlet of the first fluid transmission passageway and the distal end of the pouch (as seen in Image 1, the outlet conduit member has a fluid inlet at 29, which is between the distal end and the fluid outlet of the first fluid transmission passageway).
Regarding claim 16, Schneider in view of Moss teaches the invention as discussed above in claim 1. Additionally, Schneider teaches comprising a third fluid compartment (see Image 1 and col. 2, lines 31-40) that is fluid tight in use (col. 5, lines 3-8 and Fig. 6 teach that the clamping member 25 forces the rim 34 of the cup-shaped portion 26 into tight sealing contact with bead 16; therefore, a third fluid compartment that is fluid tight in use is formed between an inner surface of clamping member 25 and an outer surface of urine-receiving section 12) wherein:
the third fluid compartment is positioned as an intermediate fluid compartment between the second fluid compartment and the outlet conduit member (see Image 1);
a second fluid transmission passageway (see Image 1) interconnects the second fluid compartment and the third fluid compartment (Id.); and
the fluid inlet of the outlet conduit member is located within the third fluid compartment (at least inherent; see also Image 1) and the fluid outlet of the outlet conduit member is configured for coupling with a fluid collection receptacle (see col. 4, lines 22-25).
However, Schneider fails to explicitly teach that the second fluid transmission passageway comprises a unidirectional fluid flow valve that permits fluid flow to one fluid compartment in one direction and interferes with fluid reflux in the other direction, as required by the claim.
Moss teaches an analogous male external catheter (see col. 1, lines 8-9) comprising a pouch (see for example Figs. 1-4) having a first compartment (see “I” Fig. 3) and a second compartment (see “B” in Fig. 3) and a fluid transmission passageway (30 in Fig. 3) that comprises a unidirectional fluid flow valve (see col. 2, lines 57-65) that permits fluid flow from the first fluid compartment to the second fluid compartment and that interferes with fluid reflux from the second fluid compartment to the first fluid compartment (see col. 2, lines 57-65).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schneider to incorporate the teachings of Moss by including a second fluid transmission passageways at least in order to allow fluid flow into one compartment but prevent fluid flow into another compartment, as taught by Moss (see col. 2, lines 57-65). Additionally, even though Moss only discloses one fluid transmission passageway, one of ordinary skill in the art would have been reasonably motivated to include a second fluid transmission passageway at least because Moss teaches unidirectional fluid flow from one compartment to another, and one of ordinary skill in the art would have found it reasonably obvious to include more than one fluid transmission passageways between the various fluid compartments.
Regarding claim 17, Schneider in view of Moss teaches the invention as discussed above in claim 16. Additionally, Schneider in view of Moss teaches wherein the second unidirectional fluid flow valve is a flutter valve (see col. 1, lines 21-26 of Moss).
Regarding claim 19, Schneider, with reference to Image 1 above, teaches: A urine removal device (see at least Abstract and col. 1, lines 53-59) comprising:
a flexible pouch (see Image 1; as broadly claimed, the pouch is considered to be the entire device shown in Image 1; col. 2, lines 7-10 teach that the sheath is stretchable and elastic) having a proximal end and a distal end (see Image 1);
an aperture (see Image 1) disposed on an external surface of the pouch (Id.), wherein the aperture is capable of receiving at least a part of a penis (see col. 3, lines 37-40); and
an outlet conduit affixed to the flexible pouch (see Image 1), the outlet conduit comprising a fluid inlet, a fluid outlet, and a lumen connecting the fluid inlet to the fluid outlet (col. 4, lines 22-25 teaches that the drainage tube is conventional and leads to a urine receiving receptacle; therefore, the drainage tube at least inherently has an inlet, an outlet, and a lumen connecting the inlet to the outlet);
wherein:
the flexible pouch comprises:
a first fluid compartment (see Image 1; see also Fig. 5) that is fluid tight in use (see col. 2, lines 31-40; when a glans of a penis is inserted partially through the device, the 1st fluid compartment acts as a fluid compartment at least because an accidental discharge of urine would at least partially be contained within the 1st fluid compartment - see Figs. 2-3; additionally, as broadly recited, when the glans of the penis is inserted partially through the device, this is considered to be in use; in addition, col. 3, lines 34-35 describe the 1st fluid compartment as being formed of latex, therefore, it is considered to be fluid tight.);
a second fluid compartment (see Image 1; see also Fig. 5) that is fluid tight in use (see col. 2, lines 31-40 teaching that the receiving section is formed of a plastic material, which is considered to be fluid tight);
a first fluid transmission passageway (see Image 1) interconnecting the first fluid compartment and the second fluid compartment (see Fig. 1; as shown in Fig. 5, and as broadly claimed, inner sleeve 14 interconnects the first fluid compartment and second fluid compartment when a penis is inserted into sheath section 11);
a third fluid compartment (see Image 1 and col. 2, lines 31-40) that is fluid tight in use (col. 5, lines 3-8 and Fig. 6 teach that the clamping member 25 forces the rim 34 of the cup-shaped portion 26 into tight sealing contact with bead 16; therefore, a third fluid compartment that is fluid tight in use is formed between an inner surface of clamping member 25 and an outer surface of urine-receiving section 12) positioned as an intermediate fluid compartment between the second fluid compartment and the outlet conduit member (see Image 1);
a second fluid transmission passageway (see Image 1) interconnecting the second fluid compartment and the third fluid compartment (Id.);
wherein:
the aperture disposed on the external surface of the pouch is an aperture into the first fluid compartment (see Image 1);
the first fluid compartment is positioned closer to the proximal end of the pouch and further from the distal end of the pouch (see Image 1);
the second fluid compartment is positioned closer to the distal end of the pouch and further from the proximal end of the pouch (see Image 1); and
the fluid inlet of the outlet conduit member is located within the third fluid compartment (at least inherent; see also Image 1) and the fluid outlet of the outlet conduit member is configured for coupling with a fluid collection receptacle (see col. 4, lines 22-25).
However, Schneider fails to explicitly teach that each of the first and second fluid transmission passageways comprises a unidirectional fluid flow valve that permits fluid flow to one fluid compartment in one direction and interferes with fluid reflux in the other direction, as required by the claim.
Moss teaches an analogous male external catheter (see col. 1, lines 8-9) comprising a pouch (see for example Figs. 1-4) having a first compartment (see “I” Fig. 3) and a second compartment (see “B” in Fig. 3) and a fluid transmission passageway (30 in Fig. 3) that comprises a unidirectional fluid flow valve (see col. 2, lines 57-65) that permits fluid flow from the first fluid compartment to the second fluid compartment and that interferes with fluid reflux from the second fluid compartment to the first fluid compartment (see col. 2, lines 57-65).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schneider to incorporate the teachings of Moss by including a first and second fluid transmission passageways at least in order to allow fluid flow into one compartment but prevent fluid flow into another compartment, as taught by Moss (see col. 2, lines 57-65). Additionally, even though Moss only discloses one fluid transmission passageway, one of ordinary skill in the art would have been reasonably motivated to include a first and second fluid transmission passageways at least because Moss teaches unidirectional fluid flow from one compartment to another, and one of ordinary skill in the art would have found it reasonably obvious to include more than one fluid transmission passageways between the various fluid compartments. Additionally, one of ordinary skill in the art would have reasonably found the unidirectional fluid flow valve that permits fluid flow from the 1st to the 2nd compartment and that interferes with fluid reflux beneficial at least because when a penis is inserted in the device, the valve would be open to allow urine to flow through the device, and when a penis is removed from the device, the valve would be closed to prevent urine from flowing back through the device. For example, a unidirectional valve placed on the inner sleeve 14 (see Fig. 1 of Schneider) would achieve that function (see also col. 1, lines 21-26 of Moss).
Regarding claim 20, Schneider in view of Moss teaches the invention as discussed above in claim 19. Additionally, Schneider in view of Moss teaches wherein each of the unidirectional fluid flow valves is a thin-film unidirectional fluid flow valve (see col. 2, lines 57-65 of Moss; additionally, col. 1, lines 21-26 teaches that the valve can be a simple flutter valve).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider (U.S. Patent No. 4,759,753 A), in view of Moss (U.S. Patent No. 3,405,714 A), as applied above to claim 1, and further in view of Newton Jr. (U.S. Pre Grant Pub. No. 2013/0338617 A1).
Regarding claim 8, Schneider in view of Moss teaches the invention as discussed above in claim 1. However, neither Schneider nor Moss explicitly teach an air exchanger that is gas permeable and liquid impermeable, as required by the claim.
Newton Jr. teaches an analogous male external urinary catheter system (see Abstract) comprising an air vent that is air permeable and liquid impermeable (see at least para. [0014]). Additionally, the air vent will necessarily permit air exchange between the outside of the catheter and the inside of the catheter, as required by the claim.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schneider in view of Moss to incorporate the teachings of Newton Jr. by including an air exchanger at a proximal end of the urine removal device at least in order to prevent the outlet conduit member from being filled inflated with air, which can be uncomfortable for the user or lead to leakage of urine, as taught by Newton Jr. (see at least para. [0031]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider (U.S. Patent No. 4,759,753 A), in view of Moss (U.S. Patent No. 3,405,714 A), as applied above to claim 1, and further in view of Medeiros (U.S. Pre Grant Pub. No. 2009/0270822 A1).
Regarding claim 11, Schneider in view of Moss teaches the invention as discussed above in claim 1. However, neither Schneider nor Moss explicitly teach a plurality of flow directors, as required by the claim.
Medeiros teaches an analogous male incontinence device (see Abstract) comprising a wicking pad that has micro channels with wicking power (see para. [0012]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schneider in view of Moss to incorporate the teachings of Medeiros by including a wicking pad between at least two internal surfaces of the pouch or the first fluid compartment or the second fluid compartment, such that when the two internal surfaces are adjacent each other, channels exist therebetween at least in order to direct fluid flow towards collection, as taught by Medeiros (see para. [0012]).
Claims 5 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (U.S. Patent No. 4,759,753 A), in view of Moss (U.S. Patent No. 3,405,714 A), as applied above to claim 1, and further in view of Cheng (U.S. Pre Grant Pub. No. 2004/0006321 A1).
Regarding claim 5, Schneider in view of Moss teaches the invention as discussed above in claim 1. However, neither Schneider nor Moss explicitly teach wherein the first fluid transmission passageway is sized to enable fluid flow from the first fluid compartment to the second fluid compartment at a flow rate of 10 ml per min or more, as required by the claim.
Cheng teaches an analogous personal urine management system (see Abstract). Cheng further teaches urine collection rates of about 1-3 mL/min, 3-5 mL/min, and 25 mL/min (see para. [0184]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schneider in view of Moss to incorporate the teachings of Cheng by sizing the first fluid transmission passageway to enable fluid flow from the first fluid compartment to the second fluid compartment at a flow rate of 10 ml per min or more at least since it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also MPEP 2144.05(II). Since Applicant has not shown criticality of the flow rate being 10 ml per min or more (see para. [0068, 0080, 0131, and 0134] Applicant’s specification), one of ordinary skill in the art would have been reasonably motivated to discover an optimum value of a known result effective variable, such as the flow rate, without producing any new or unexpected results. See In re Boesch, 205 USPQ 215 (CCPA 1980); see also MPEP § 2144.05(II).
Regarding claim 13, Schneider in view of Moss teaches the invention as discussed above in claim 1. Additionally, Schneider in view of Moss teaches wherein the outlet conduit is coupled to the fluid collection receptacle by a drain tube (see drainage tube 23 in Fig. 1 and col. 4, lines 19-25). However, neither Schneider nor Moss explicitly teach wherein the drain tube has one or more capillary structures, as required by the claim.
Cheng teaches an analogous personal urine management system (see Abstract) comprising a tube with capillary spacers provided in and on the walls of the tube (see para. [0168]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schneider in view of Moss to incorporate the teachings of Cheng by including one or more capillary structures on the drain tube at least because such structures are well known in the art, as evidenced by their disclosure in Cheng (see para. [0168]) and one skilled in the art would have been reasonably motivated to apply the known technique of Cheng to the device of Schneider in view of Moss with the predictable result of having a tube that performs capillary action to draw urine away from the urine removal device and towards the collection receptacle.
Regarding claim 14, Schneider, in view of Moss, further in of Cheng teaches the invention as discussed above in claim 13. Additionally, Schneider, in view of Moss, and further in view of Cheng teaches wherein an open-cell foam assembly is positioned as a fluid transmission intermediate between the outlet conduit member and the drain tube, wherein the open-cell foam assembly defines a plurality of fluid channels, each of said fluid channels interconnecting the outlet conduit member and the drain tube (para. [0147] of Cheng teaches open cell foams are included on the walls of the tubing; therefore, the open cell foam is a fluid transmission intermediate that is positioned between the outlet conduit member and the drain tube).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider (U.S. Patent No. 4,759,753 A), in view of Moss (U.S. Patent No. 3,405,714 A), further in view of Cheng (U.S. Pre Grant Pub. No. 2004/0006321 A1), as applied above to claim 14, and further in view of Cermak (U.S. Patent No. 5,318,550 A).
Regarding claim 15, Schneider, in view of Moss, further in of Cheng teaches the invention as discussed above in claim 14. However, neither Schneider, Moss, nor Cheng explicitly teach a suction bulb, as required by the claim.
Cermak teaches an analogous urine collecting apparatus (see Abstract) that comprises a resilient squeeze bulb positioned between a one-way valve 28 and collection container 14 (see at least Fig. 1 and col. 2, lines 25-31).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schneider, in view of Moss, further in of Cheng to incorporate the teachings of Cermak by including a suction bulb as a fluid transmission intermediate between the outlet conduit member and the drain tube such that the suction bulb as a fluid inlet coupled with the outlet conduit and a fluid outlet coupled with an inlet of the fluid collection receptacle at least in order to allow for pumping urine towards the collection container when the bulb is squeezed and for providing a suction in the urine removal device when the bulb is released after squeezing, as taught by Cermak (see col. 1, lines 40-45).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider (U.S. Patent No. 4,759,753 A), in view of Moss (U.S. Patent No. 3,405,714 A), as applied above to claim 1, and further in view of Elson (U.S. Pre Grant Pub. No. 2005/0101924 A1).
Regarding claim 18, Schneider in view of Moss teaches the invention as discussed above in claim 1. However, neither Schneider nor Moss explicitly teach an adhesive patch attached to the flexible pouch for fastening the flexible pouch to a patient's suprapubic region, as required by the claim.
Elson teaches an analogous male urinary incontinence device (see Abstract) comprising an adhesive-backed tape strip 31 (see Fig. 1 and para. [0081]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schneider in view of Moss to incorporate the teachings of Elson by providing an adhesive patch attached to the flexible pouch at least because such structure is well known in the art, as evidenced by its disclosure in Elson (see Fig. 1 and para. [0081]) and one of ordinary skill in the art would have reasonably been motivated to combine the adhesive patch of Elson with the device of Schneider in view of Moss yielding a predictable result of having a urine removal device that has an adhesive patch. Additionally, the adhesive patch is configured for fastening the flexible pouch to a patient's suprapubic region, as required by the claim.
Conclusion
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/KAI H WENG/ Primary Examiner, Art Unit 3781
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