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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 25, 2026, has been entered.
Response to Amendment
The amendments filed March 25, 2026, have been entered. Claims 1, 28, and 38 are amended. Claims 1, 2, 4, 5, 7, 8, 10, 13, 14, 17, 18, 21, 23, 27, 28, 31-33, 38, and 42-45 are currently pending.
Response to Arguments
Applicant's arguments filed March 25, 2026, have been fully considered and are persuasive. A new rejection has been applied using Pinlac US 111877948 B2 to address the first and second portions of the base instead of previously used Sharma.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “first portion” and a “second portion”, and “a proximal portion” of the base must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The terms a “first portion” and a “second portion”, and “a proximal portion” are not found in the originally filed specification or claims.
It was understood during the interview from July 28, 2025, that the first portion of the base was attached to the sheath while the second portion of the base was not attached to the sheath and extended beyond the sheath.
Claim Rejections - 35 USC § 112
Claims 1 and 28 and 38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Applicant’s specification paragraph [0032] teaches away from a detachable base since it could create leaks between the sheath and base. In paragraph [0071] while the base and sheath are separate parts initially, they are later permanently attached. Paragraphs [0072-0074] teach the base is permanently attached to the sheath either before, during or after attaching the base to the skin. It is unclear how the base can be not permanently secured to the base when the specification teaches it is permanently attached at some point to the sheath.
As noted above it is understood based on the interview that the applicant is claiming the section of the base that extends beyond the sheath and therefor is not attached to the sheath; however, the current phrasing is unclear.
The Examiner suggests that applicant describe the base portions as extending away from the connection area of the sheath vs the base portion attached to the sheath in order to delineate the different portions of the base and /or perhaps annotated figure 1c which clearly shows a section of the base free from the sheath which extends beyond it. Paragraph [0059] clearly supports the unclaimed shape of the base and teaches the sheath is attached to the apex section of the base thereby leaving a larger area that is free from the sheath to connect to the mons pubis.
The specification describes an embodiment where the base and sheath are not initially attached, and are later attached permanently to each other (¶ [0071], [0072], [0074]). Examiner alternatively suggests to rephrase these claims in terms of “… the second portion not [[permanently]] initially secured to the proximal region of the sheath or the second portion configured to not be [[permanently]] initially secured to the proximal end of the sheath.”
Depending claims 2, 4-5, 7-8, 10, 13-14, 17-18, 21, 23, 27, 31-33, 42-45 are also rejected as they depend from a rejected claim.
Claim Rejections - 35 USC § 103
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) 1-2, 4-5, 7-8, 10, 13-14, 17-18, 21, 23, 28, 31-33, 38, and 42-45 are rejected under 35 U.S.C. 103 as being unpatentable over Kubo US 5300052 in view of Pinlac US 11877948 B2, Lee US 3511241, and Palumbo US 2003/0073964 A1.
Regarding claim 1 and 38, Kubo discloses a fluid collection assembly (figure 4 and abstract), comprising: a sheath (generally shown by 1, fig 2a) including: at least one fluid impermeable barrier including a first panel (5, fig 2a) and a second panel (2, figs 1a, and 2b), the at least one fluid impermeable barrier defining a chamber at least partially defined by the first panel and the second panel (Col 4 lines 6-16 discloses a first and second / front and rear face which form the chamber, and claim 1 discloses the formed bag is impermeable or waterproof), the at least one fluid impermeable barrier defining an outlet (11, fig 3) at a distal end of the sheath (Col 4 lines 17-29) and an opening (3 fig 3) at a proximal end of the sheath (fig 3, Col 3 lines 53-65), the proximal end of the sheath including proximal edges (edges of (2) and (5) which connect together above the opening (3) as shown in at least fig. 4) opposite the distal end that are attached together (Col 3 line 53 – Col 4 line 10 which discloses the bag is formed from front and rear faces which are attached along their periphery); and at least one porous material (7+9 which form the porous material, Col 4 lines 15-20) and disposed in the chamber (figure 3), the at least one porous material including a sheet (7 is a membrane/ sheet, Col 4 lines 15-20), at least a portion of the at least one porous material is hydrophobic (Col 4 lines 15-20 notes a hydrophobic material);
a base (13 +12 fig 2a) including a first portion secured to or configured to be secured to the proximal end of the sheath, the base configured to be attached to skin surrounding a penis, the base defining an aperture that corresponds to the opening of the sheath (Col 5 line 63- Col 6 lines 3).
Per claim 38 Kubo discloses a method of attaching the base to the user (Col 6 lines 39-49).
Kubo fails to disclose the base is permanently secured to the sheet; however, it would have been obvious to one of ordinary skill in the art before the effective filing date to have made the bottom base plate 12 permanently secured to the sheath as the sheath is coupled to the base (12) which as a unit is then attached to the other base plate (13) which is pre-attached to the user (Col. 4 lines 40-59). Making parts integrally or permanently formed together is merely a matter of obvious engineering choice, In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) and MPEP 2144.04. II. V. B.
Kudo additionally fails to disclose wherein the fluid impermeable barrier and the at least one porous material directly define a penis receiving area extending from at least the opening to the outlet, the at least one porous material only positioned on one side of the penis receiving area and wherein at least a portion of the fluid impermeable barrier directly defining the penis receiving area is at least partially transparent and a second portion of the base that is not permanently secured to the proximal end or proximal region of the sheath.
Pinlac taches a urinary collection assembly thereby being in the same field of endeavor as the instant claims. Pinlac teaches a base plate/ attachment means (110, fig 3 that allows the device to be attached to the user. The base of Pinlac clearly has a section that extends beyond the sheath area and as such has a first and second portion (ie a first portion that is secured to the sheath and a second portion that is not).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to have changed the shape of the attachment base to allow for an extend attachment area that goes beyond the sheath as a larger attachment area will provide better / more area for product adhesion. Pinlac provides a known shape that extends beyond the sheath and therefore it would have been obvious to try.
Kubo and Pinlac still fail in combination to disclose the partial transparency of the impermeable barrier. According to applicant’s specification (paragraph [0032]) materials that can be partially transparent are polyethylene, polypropylene, polycarbonate, or polyvinyl chloride for example. The primary reference Kubo makes no mention of transparency. However, Kubo does disclose the same material for the sheath (polyethylene- Col 5 lines 7-24) as applicant mentions in their specification as such the same material should have the same properties. Additionally, Lee US 3511241 teaches a urine collection system made from “polyethylene or the like which is transparent” so the user can observe the contents of the bag (Col 4 lines 35-45). Lee provides clear support for polyethylene being known to be transparent and motivation for using a transparent material.
Therefore, it would have obvious to one of ordinary skill in the art before the effective filing date to have made the sheath to be at least partially transparent in order to obverse the urine as taught by Lee. Additionally, Lee supports the material itself is known to be transparent.
Kubo, Pinlac, and Lee still fail in combination to disclose wherein the fluid impermeable barrier and the at least one porous material directly define a penis receiving area extending from at least the opening to the outlet, the at least one porous material only positioned on one side of the penis receiving area.
While Kubo discloses a porous material inside the urinary receiving area the material appears to be located in the lower half of the penis receiving area instead of only one side (as seen in Kubo fig. 3).
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as Kubo. Palumbo teaches a urine porous material (or absorbent, 15, figure 3) disposed within a sleeve (formed by 11); the porous material extending from a proximal end to a distal end of the sleeve and therefore configured to extend across the opening when the sheath is resting on a flat surface and a penis is not disposed in the chamber (fig 3, additionally no structures are present that prevent the flattening of Palumbo when not in use).
It would have been obvious to one of ordinary skill before the effective filling date to have modify the absorbent material of Kubo such that it extends from the proximal end to the distal end of the sleeve as suggested by Palumbo. One of ordinary skill would have found it obvious to try extending/positioning the absorbent as suggested by Palumbo with a reasonable expectation of success of collecting and retaining urine from the male member. Additionally, the penis can move through a range of angles throughout the day; thereby, making it obvious to position the material in a way that would cover the range of possible movement rather than solely at the lower half of the collection bag as shown Kubo.
Regarding claim 2, Kubo fails to disclose wherein at least a portion of the at least one fluid impermeable barrier is permeable to air.
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as Kubo. Palumbo teaches the material for the urine collection bag (11) should be impermeable while breathable [0020].
It would have been obvious to one of ordinary skill in the art before the effective filing date to have changed the waterproof material of Kubo to a breathable and waterproof material as taught by Palumbo for improved patient comfort [0038].
Regarding claim 4, Kubo as modified by Lee above teaches the sheath’s impermeable material is at least partially transparent.
Regarding claim 5, Kubo, wherein the second panel is configured to be positioned adjacent to an individual using the fluid collection assembly during use (fig 4).
Regarding claim 7, Kudo discloses wherein the first panel and the second panel are formed from distinct sheets (see figure 4).
Regarding claim 8, Kubo fails to disclose wherein the first panel and the second panel are integrally formed.
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as Kubo. Palumbo teaches the material for the urine collection bag may be formed from two separate sheets or integrally [0021].
It would have been obvious to one of ordinary skill in the art before the effective filing date to have form the impermeable barrier of Kubo from one as Palumbo teaches a comparable urine impermeable barrier / bag 11 can be formed from a single or multiple sheets [0021]. Therefore, it would have been obvious to try as there are multiple known formation means. Additionally, In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) supports making known parts integral.
Regarding claim 10, Kubo wherein the fluid collection assembly is configured to, when a penis is inserted into the chamber through the opening, the penis is positioned between at least a portion of the second panel and the at least one porous material (Col 6 lines 15-38) (fig 4).
Regarding claim 13-14, Kubo fails to disclose wherein the at least one porous material includes a first layer, a second layer, and a plurality of fibers forming a layer between the first layer and the second layer per claim 13 and wherein the at least one porous material includes at least one of a hydrophobic foam or cotton per claim 14.
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as Kubo. Palumbo teaches the porous material can be loose fiber or between fibrous sheets [0044-45].
It would have been obvious to one of ordinary skill in the art before the effective filing date to have changed the porous material of Kubo to a porous material as taught by Palumbo based on the principle of simple substitution as both references teach a known porous material used to collect urine; therefore, the results would be predictable i.e. both can collect urine.
Regarding claim 17 and 18, Kubo teaches wherein the base includes: a substrate defining a top surface (12, fig 2a) and a bottom surface (13, fig 2a), wherein, during use, the top surface is configured to be closer to the sheath than the bottom surface and the bottom surface is configured to be closer to skin surrounding a penis than the top surface (Col. 4 lines 30-59).
Kubo fails to disclose a first adhesive layer attached at least a portion of the bottom surface, the first adhesive layer configured to attach the base to the skin surrounding the penis per claim 17 and wherein the first adhesive layer includes at least one of a silicone-based adhesives, an acrylic gel adhesive, or a hydrogel per claim 18.
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as Kubo. Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as Kubo. Palumbo teaches a base or (flange 12) with two sides one attached to the collection bag and one attached to the user via an adhesive ([0043 and fig 3) such as a hydrogel [0046].
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added an adhesive to the base plate of Kubo as taught by Palumbo in order to provide improved attachment means.
Regarding claim 21, Kubo as modified by Pinlac fail to disclose wherein the base exhibits a generally triangular shape.
It would have been obvious to one of ordinary skill in the art before the effective filling date to have changed the shape of the base plate to provide the most comfortable and user-friendly device. Changing the shape is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 23, Kubo discloses wherein the sheath is free from at least one of one or more rings exhibiting a rigidity that is greater than the at least one fluid impermeable barrier and the at least one porous material or a cap exhibiting a rigidity that is greater than the at least one fluid impermeable barrier and the at least one porous material (see fig 3 which shows no rings on the sheath or cap).
Regarding claim 28, Kubo discloses a fluid collection assembly (figure 4 and abstract), comprising: a sheath (generally shown by 1, fig 2a) including: at least one fluid impermeable barrier including a first pane (5, fig 2a) and a second panel (2, fig 2b), the at least one fluid impermeable barrier defining a chamber at least partially defined by the first panel and the second panel (Col 4 lines 6-16 discloses a first and second / front and rear face which for the chamber and claim 1 discloses the formed bag is impermeable or waterproof), the at least one fluid impermeable barrier defining an outlet (11, fig 3) at a distal end of the sheath (Col 4 lines 17-29) and an opening (3 fig 3) at a proximal end of the sheath (fig 3, Col 3 lines 53-65), the proximal end of the sheath including proximal edges opposite the distal end that are attached together (Col 3 lines 53-65 which discloses the bag is from of front and rear face); and at least one porous material (7+9 which from the porous material, Col 4 lines 15-20) an disposed in the chamber (figure 3), the at least one porous material including a sheet (7 is a membrane/ sheet, Col 4 lines 15-20), at least a portion of the at least one porous material is hydrophobic (Col 4 lines 15-20 notes a hydrophobic material); and a base (13 +12 fig 2a) including a first portion secured to or configured to be secured to the proximal end of the sheath, the base configured to be attached to skin surrounding a penis, the base defining an aperture that corresponds to the opening of the sheath (Col 5 line 63- Col 6 lines 3).
Kubo does not explicitly teach attaching the panels together or disposing a porous sheet into the sheath.
However, these steps must occur for the device to be made. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have attached the two panels and disposed the porous material in order to form the device of Kudo.
Kudo additionally fails to disclose a second portion of the base that is not permanently secured to the proximal end of the sheath and wherein the first and second portions are immediately adjacent to and abut the sheath.
Pinlac taches a urinary collection assembly thereby being in the same field of endeavor as the instant claims. Pinlac teaches a base plate/ attachment means (110, fig 3 that allows the device to be attached to the user. The base of Pinlac clearly has a section that extends beyond the sheath area and as such has a first and second portion (ie a first portion that is secured to the sheath and a second portion that is not).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to have changed the shape of the attachment base to allow for an extend attachment area that goes beyond the sheath as a larger attachment area will provide better / more area for product adhesion. Pinlac provides a known shape that extends beyond the sheath and therefore it would have been obvious to try.
Kubo fails to disclose the base is permanently secured to the sheet; however, it would have been obvious to one of ordinary skill in the art before the effective filing date top have made the bottom base plate 12 permanently secured to the sheath as the sheath is coupled to the base (12) which as a unit is then attached to the other base plate (13) which is pre attached to the user (Col. 4 lines 40-59). Making parts integrally or permanently formed together is merely a matter of obvious engineering choice, In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) and MPEP 2144.04. II. V. B.
Kubo and Pinlac additionally fail to disclose wherein the fluid impermeable barrier and the at least one porous material directly define a penis receiving area extending from at least the opening to the outlet, the at least one porous material only positioned on one side of the penis receiving area and wherein at least a portion of the fluid impermeable barrier directly defining the penis receiving area is at least partially transparent.
According to applicant’s specification (paragraph [0032]) materials that can be partially transparent are polyethylene, polypropylene, polycarbonate, or polyvinyl chloride for example. The primary reference Kubo makes no mention of transparency. However, Kubo does disclose the same material for the sheath (polyethylene- Col 5 lines 7-24) as applicant mentions in their specification as such the same material should have the same properties. Additionally, Lee US 3511241 teaches a urine collection system made from “polyethylene or the like which is transparent” so the user can observe the contents of the bag (Col 4 lines 35-45). Lee provides clear support for polyethylene being known to be transparent and motivation for using a transparent material.
Therefore, it would have obvious to one of ordinary skill in the art before the effective filing date to have made the sheath to be at least partially transparent in order to obverse the urine as taught by Lee. Additionally, Lee supports the material itself is known to be transparent.
Kubo, Pinlac, and Lee still fail in combination to disclose wherein the fluid impermeable barrier and the at least one porous material directly define a penis receiving area extending from at least the opening to the outlet, the at least one porous material only positioned on one side of the penis receiving area.
While Kubo discloses a porous material inside the urinary receiving area the material appears to be located in the lower half of the penis receiving area instead of only one side (as seen in Kubo fig. 3).
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as Kubo. Palumbo teaches a urine porous material (or absorbent, 15, figure 3) disposed within a sleeve (formed by 11); the porous material extending from a proximal end to a distal end of the sleeve and therefore configured to extend across the opening when the sheath is resting on a flat surface and a penis is not disposed in the chamber (fig 3, additionally no structures are present that prevent the flattening of Palumbo when not in use).
It would have been obvious to one of ordinary skill before the effective filling date to have modify the absorbent material of Kubo such that it extends from the proximal end to the distal end of the sleeve as suggested by Palumbo. One of ordinary skill would have found it obvious to try extending/positioning the absorbent as suggested by Palumbo with a reasonable expectation of success of collecting and retaining urine from the male member. Additionally, the penis can move through a range of angles throughout the day; thereby, making it obvious to position the material in a way that would cover the range of possible movement rather than solely at the lower half of the collection bag as shown Kubo.
Regarding claim 31, Kubo disclose wherein the first panel and the second panel are formed from a thin-walled tube (fig 1 c shows a tube and the bag is disclosed as being able to be worn under clothing so is interpreted to be thin, furthermore thin is relative- see 112b).
Regarding claim 32, Kubo fails to explicitly disclose wherein attaching the first panel and the second panel together includes at least one of heat sealing, RF welding, or ultrasonic welding the first panel to the second panel.
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as Kubo. Palumbo teaches the material for the urine collection bag may be formed from two separate sheets and sealed together [0021].
It would have been obvious to one of ordinary skill in the art before the effective filing date to have attached the first and second panels of Kubo using a heat sealing process as suggested by Palumbo in order to form a water tight seal and a fluid impermeable sheath as desired by both Kubo and Palumbo.
Regarding claim 33, Kubo fails to explicitly disclose disposing the at least one porous material in the chamber includes, before attaching the first panel and the second panel together, positioning the at least one porous material between the first panel and the second panel; and wherein attaching the first panel and the second panel together includes attaching the at least one porous material to at least one of the first panel or the second panel.
However, the porous material of Kubo is retained by two sheets within the bag; therefore, the material must be disposed within prior to sealing the ends. Furthermore, the chamber into which the porous material is placed into is not fully formed until the first and second panels are attached. Therefore, Kubo appears to implicitly teach the claim limitation wherein the porous material is disposed prior to attaching the first and second panel. Furthermore; and in the event that the implicit teaching is not immediately clear, it would have been obvious to one of ordinary skill in the art before the effective filing date to have disposed the porous material within the “chamber” prior sealing the panels in order to successfully form the device of Kubo.
Regarding claim 42, Kubo further discloses the porous material exhibits substantially no absorption (Col 4 lines 15-20 notes a hydrophobic material which will not absorb).
Regarding claim 43, Kubo fails to disclose the sheet configured to occupy substantially all of the chamber, lie flat, and extend across the opening when the sheath is resting on a flat surface and a penis is not disposed in the chamber.
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as Kubo. Palumbo teaches a urine porous material (or absorbent, 15, figure 3) disposed within a sleeve (formed by 11); the porous material extending from a proximal end to a distal end of the sleeve and therefore configured to extend across the opening when the sheath is resting on a flat surface and a penis is not disposed in the chamber (fig 3, additionally no structures are present that prevent the flattening of Palumbo when not in use).
It would have been obvious to one of ordinary skill before the effective filling date to have modify the absorbent material of Kubo such that it extends from the proximal end to the distal end of the sleeve as suggested by Palumbo. One of ordinary skill would have found it obvious to try extending/positioning the absorbent as suggested by Palumbo with a reasonable expectation of success of collecting and retaining urine from the male member. Additionally, the penis can move through a range of angles throughout the day; thereby, making it obvious to position the material in a way that would cover the range of possible movement rather than solely at the lower half of the collection bag as shown Kubo.
Regarding claim 44, Kubo discloses the fluid impermeable barrier includes distal edges opposite the proximal edges, the fluid impermeable barrier includes one or more first lateral edges extending from the proximal edges to the distal edges and one or more second lateral edges extending from the proximal edges to the distal edge, the one or more first lateral edges opposite the one or more second lateral edges See figure annotated below.
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Kubo fails to disclose the at least one porous material extending from the proximal edges to the distal edges and extending from substantially all of the one or more first lateral edges to substantially all of the one or more second lateral edges.
Palumbo teaches a urinary collection device (abstract) thereby being in the same filed of endeavor as Kubo. Palumbo teaches a urine porous material (or absorbent, 15, figure 3) disposed within a sleeve (formed by 11); the porous material extending from a proximal end to a distal end of the sleeve and therefore configured to extend across the opening when the sheath is resting on a flat surface and a penis is not disposed in the chamber (fig 3, additionally no structures are present that prevent the flattening of Palumbo when not in use).
It would have been obvious to one of ordinary skill before the effective filling date to have modify the absorbent material of Kubo such that it extends from the proximal end to the distal end of the sleeve as suggested by Palumbo. One of ordinary skill would have found it obvious to try extending/positioning the absorbent as suggested by Palumbo with a reasonable expectation of success of collecting and retaining urine from the male member. Additionally, the penis can move through a range of angles throughout the day; thereby, making it obvious to position the material in a way that would cover the range of possible movement rather than solely at the lower half of the collection bag as shown Kubo.
Regarding claim 45, Kubo as modified by Palumbo discloses the at least one porous material includes a signle sheet extending an entire length of the sheath (see Palumbo fig 3, where (15) is a single sheet extending the entire length of the sheath).
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Kubo US 5300052 in view of Pinlac US 11877948 B2, Lee US 3511241, and Palumbo US 2003/0073964 A1 and in further view of Forral US 2004/0176746 A1.
Regarding claim 27, Kubo discloses the fluid collection assembly of claim 1: a fluid storage container (23, fig 4).
Kubo as modified by Pinlac, Lee, and Palumbo fails to disclose a vacuum source configured to apply a suction force; and at least one conduit connected to the outlet and in fluid communication with the vacuum source and the fluid storage container.
Forral teaches a urine collection apparatus (abstract) thereby being in the same field of endeavor. Forral teaches a vacuum source (60) with a conduit connecting the outlet (30) and the fluid container (40) and the vacuum source (60) (abstract and fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have added a vacuum to the storage container of Kubo to better assist with drainage from the collection bag thereby helping the user to feel drier (Forral [0085]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20170100276 A1, US 20130138064, and US 3613123 are related and might be pertinent to alterative embodiments disclosed in the specification but not claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA E BURNETTE whose telephone number is (571)272-9574. The examiner can normally be reached M-S: 0830-1900 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (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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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/Adam Marcetich/Primary Examiner, Art Unit 3781
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