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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 7, 2026, has been entered.
Response to Amendment
The amendments May 7, 2026, have been entered. Claims 2, 5, 7- 10, 12-13 and 15-23 are currently pending. Claims 2, 5, 9, 15-16, 20-21 have been amended. Claims 1, 3-4, 11, and 14 were previously canceled.
Response to Arguments
Applicant's arguments filed May 7, 2026, have been fully considered. The arguments are not persuasive.
Regarding claim 2, applicant argues that the newly added limitation is not new matter. The examiner appreciates the applicant’s annotated figures. The terms applicant has added are not found in the originally filed specification. Additionally, while the subparts can be inferred from the figures how the parts are attached cannot be and as such is new matter.
Additionally with regards to claim 2, the layer of permeable material of Washington does in fact have terminating edges which are positioned at least proximate to the impermeable material’s lateral edges (see annotated figure below).
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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:
top portion, bottom portion, and opposing lateral edges of the impermeable material, supported by figures however not found in specification
lateral side edges, supported by figures however not found in specification
first terminating edges of the first permeable layer, supported by figures however not found in specification
second terminating edges of the second permeable layer, supported by figures however not found in specification
first layer of permeable material is referred to as the wicking material (14) in the specification the terms not being the same causes confusion when referencing the specification
second layer of permeable material is referred to as the porous material (12) in the specification the terms not being the same causes confusion when referencing the specification
first and second region and opposing lateral edges of the impermeable material, supported by figures however not found in specification
Applicant has a four-page specification and two figures. The examiner is trying to give the applicant the broadest reasonable interpretation with renaming parts; however, the support needs to be clear, and the specification amended to have the claimed terminology without introducing new matter, so the record is clear.
“While an applicant is not limited to the nomenclature used in the application as filed, he or she should make appropriate amendment of the specification whenever this nomenclature is departed from by amendment of the claims so as to have clear support or antecedent basis in the specification for the new terms appearing in the claims. This is necessary in order to insure certainty in construing the claims in the light of the specification. See 37 CFR 1.75, MPEP § 608.01(i) and § 1302.01 and § 2103.” MPEP 608.01(o)
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 2 and 20 and depending claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The newly added limitation “the bottom and top portion being secured together at opposing lateral edges” is new matter. While the figures support the impermeable material has having a top and bottom portion, the figures and specification fail to provide support for the portions being secured together. The figures support a shaped impermeable material but not joining or securing two parts together as the current claim language implies two separate parts which is outside of the scope of the disclosure.
Claim 9 and 16 and depending claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The newly added limitation “the first and second region being secured together at opposing lateral edges” is new matter. While the figures support the impermeable material has having a first and second region, the figures and specification fail to provide support for the regions being secured together. The figures support a shaped impermeable material but not joining or securing two parts together as the current claim language implies two separate parts which is outside of the scope of the disclosure.
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.
Claims 2, 7-8, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Washington US 4886508 and evidenced by Peterson US 5246454 and Di Mauro M, Tonioni C, Cocci A, Kluth LA, Russo GI, Gomez Rivas J, Cacciamani G, Cito G, Morelli G, Polloni G, di Maida F, Giunti D; Trauma, Reconstructive Urology, Men’s Health Working Parties of the European Association of Urology (EAU) Young Academic Urologists (YAU). Penile length and circumference dimensions: A large study in young Italian men. Andrologia. 2021 Jul;53(6):e14053. doi: 10.1111/and.14053. Epub 2021 Mar 21. PMID: 33748967; PMCID: PMC8243978 (here after referred to as Di Mauro) in view of Kuntz US 4747166.
With regards to claim 2, Washington discloses a urine collecting device (abstract) comprising:
an impermeable material (the body 12, figure 1 is formed from silicone rubber Col 8 lines 46-48, Peterson is used as evidence that silicone rubber is impermeable Peterson Col 1 lines 16-18) having a top and bottom portion (see figure below), the top portion and the bottom portion being secured together at opposing lateral edges (see figure below, and Col 2 lines 40-51 which body (or impermeable material) has a top, bottom and side walls that are able to be deformed and return to their original shape resulting in container that functions as unit);
a first layer of permeable material having a first side oriented towards the top portion (insert 46, figure 1 is noted as a fluid permeable insert that is multi-layered Col 6 lines 21-38 and since the impermeable material has a top and bottom portion and the insert resides within it will be oriented towards the top and bottom), the first layer of permeable material having opposing first terminating edges positioned at least proximate to the opposing lateral edges of the impermeable material (Col 2 lines 24-39 which note the insert (or permeable material) contacts the side walls or lateral edges of the impermeable material);
a second layer of permeable material positioned at least partially between the first layer of permeable material and at least a portion of the bottom portion of the impermeable material (insert 46, figure 1 is noted as a fluid permeable insert that is multi-layered Col 6 lines 21-38 and since the impermeable material has a top and bottom portion and the insert resides within it will be oriented towards the top and bottom), having opposing second terminating edges positioned at least proximate to the opposing lateral edges of the impermeable material and the first terminating edges of the first layer of permeable material (Col 2 lines 24-39 which note the multi-layered insert (or permeable material) contacts the side walls or lateral edges of the impermeable material);
a chamber of void space (or cup receptacle, 39 Col. 5 lines 65-68) positioned at least partially between the top portion and the bottom portion of the impermeable material (see figure 4), the chamber being positioned between and defined by a portion of the second layer of permeable material and at least some of the impermeable material (see figure 4 and Col 5 lines 65-68, which shows a chamber of void space between and defined by the permeable material and concave section of the impermeable material);
a port extending through the impermeable material and in fluid communication with the chamber, the port being configured to transport urine from the chamber through the port (Figure 4 and Col 5 line 62 – Col 6 line 21 discloses a port or drainage outlet 38 extending from the impermeable material to the chamber that allow for the removal of urine from the chamber); and
a receptacle opening (24- figure 1) defined at least partially by the impermeable material (the opening 24 is formed in the body 12 which is formed from silicone rubber Col 8 lines 46-48, Peterson is used as evidence that silicone rubber is impermeable Peterson Col 1 lines 16-18) that is positioned generally opposite to the chamber (figure 4 shows the opening 24 generally opposite the chamber 39); and
wherein the top portion of the impermeable material is configured to be spaced from the first side of the first layer of permeable material (Fig 2 shows a gap between the impermeable material and the first side layer of the permeable material).
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Washington also fails to disclose the receptacle opening including a length and a width size and dimensions to receive at least a head of a penis of a male and retain the head of the penis disposed in the receptacle when the male is lying on his back such that the urine discharged from the head of the penis flows through the first layer of permeable material and the second layer of permeable material into the chamber when a partial vacuum is applied to the port or that the wherein the top portion of the impermeable material is configured to be spaced from the first side of the first layer of permeable material when the head of the penis is within the receptacle opening.
However, Washington teaches a device shaped to surround and cover the female labia, the opening is similar shaped to the penis. Therefore, the device of Washington is interpreted to be fully capable of functioning as claimed and receiving at least the head of the penis of a user, where, for patentability, the functions of apparatus claims do not need to be taught by the prior art, but only have to have structures that are capable of performing the claimed function. Additionally, the opening of Washington is sized accordingly “The top opening 24 is about 1 inch (2.5 cm) wide and 3 1/4 inch (8.3 cm) long with about a 1 inch (2.5 cm) narrow slot 26 at one end for ease in inserting or removing an insert.” Col 11 line 68- Col. 12 line 4. According to the study by Di Mauro The average penis is 7-15cm* depending on erection status this translates to 2.76 – 5.91 inches in length as such the device of Washington should fit easily fit the tip of the penis from a length perspective. The width of Washington is about 1 inch or 2.5cm. The above study only provides the circumference of the penis. If the diameter is considered a suitable estimation for the width, the width can be calculated by the following modifying formula to find the circumference or girth: circumference = diameter* pi or simply put D=C/π.
The girth ranges from 7-15cm* which equates to a diameter (or width) of 2.23- 4.77cm (0.88- 1.88 inches) which falls into the approximate opening dimension of Washington. As such while not designed for males the opening is still sized for some males.
*The date is pulled from tables 2-4 which breaks down the measures based on geographical location.
MPEP 2114 discuses functional language and notes “[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)”. In short applicant’s functional limitation for the device to be sized for a male is still met even though Washington is designed to be used for a female as the opening does not prevent some men from using the device based on the evidence above and all the structural limitations are met as modified in the rejection below.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the shape of the device according to Washington such that it narrows beyond the opening as taught by Keane, and one skill would have been motivated to do so, in order to provide improved fit. Furthermore, changing the shape to a known configuration as taught by Keane can be obtained by one of ordinary skill with a reasonable expectation of success as an obvious design choice. The courts have held that the configuration or shape was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant; In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) MPEP 2144.04 IV.
Washington fails to disclose wherein the second layer of permeable material different than the first layer of permeable material.
Kuntz teaches a urine collect device being in the same field of endeavor as Washington. Kuntz teaches wherein the first layer of permeable material includes a wicking material to help the user feel dry Col 4 lines 48-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added a layer of wicking material to the device of Washington to help improve the user’s sensation of dryness as taught by Kuntz. Thus modified Washington would have two distinct permeable material layers.
With regards to claim 7, Washington discloses a portion of the first layer of permeable material is positioned opposite to the receptacle opening and adjacent to the portion of the second layer of permeable material defining the chamber (see figure 4 which shows the permeable material opposite the chamber).
With regards to claim 8, Washington discloses the impermeable material includes a lip (29 and 31, figure 1) at least partially surrounding the receptacle opening (Col. 5 lines 36-40).
With regards to claim 22, Washington clearly discloses the receptacle opening includes a first end region having a first maximum width and a second end region having a second maximum width less than the first maximum width of the first end region (see figure 3 and where the opening narrows at one end).
Claims 9-10, 12-13, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Washington US 4886508 and evidenced by Peterson US 5246454 and Di Mauro M, Tonioni C, Cocci A, Kluth LA, Russo GI, Gomez Rivas J, Cacciamani G, Cito G, Morelli G, Polloni G, di Maida F, Giunti D; Trauma, Reconstructive Urology, Men’s Health Working Parties of the European Association of Urology (EAU) Young Academic Urologists (YAU). Penile length and circumference dimensions: A large study in young Italian men. Andrologia. 2021 Jul;53(6):e14053. doi: 10.1111/and.14053. Epub 2021 Mar 21. PMID: 33748967; PMCID: PMC8243978 (here after referred to as Di Mauro) in view of Kuntz US 4747166 and Keane US 3349768.
With regards to claim 9, Washington discloses a urine collecting device (abstract) comprising: an impermeable material (discloses the body 12, figure 1 is formed from silicone rubber Col 8 lines 46-48, Peterson is used as evidence that silicone rubber is impermeable Peterson Col 1 lines 16-18) including a first region and a second region generally opposite to the first region (see annotated figure below (the term surface is used instead of region), the first and second region being secured together at opposing lateral edges (see figure below, and Col 2 lines 40-51 which body (or impermeable material) has a top, bottom (or first and second region) and side walls that are able to be deformed and return to their original shape resulting in container that functions as unit);
a first layer of permeable material (insert 46, figure 1 is noted as a fluid permeable insert that is multi-layered Col 6 lines 21-38) positioned at least partially between the first surface and the second surface (see figure below) and having a first side oriented towards the top portion (since the impermeable material has a first and second region and the insert resides within it will be oriented accordingly), the first layer of permeable material having opposing first terminating edges positioned at least proximate to the opposing lateral edges of the impermeable material (Col 2 lines 24-39 which note the insert (or permeable material) contacts the side walls or lateral edges of the impermeable material);
a second layer of permeable material positioned at least partially between the first layer of permeable material and at least a portion of the second region of the impermeable material (insert 46, figure 1 is noted as a fluid permeable insert that is multi-layered Col 6 lines 21-38 and since the impermeable material has a top and bottom portion and the insert resides within it will be oriented towards the top and bottom), having opposing second terminating edges positioned at least proximate to the opposing lateral edges of the impermeable material and the first terminating edges of the first layer of permeable material (Col 2 lines 24-39 which note the multi-layered insert (or permeable material) contacts the side walls or lateral edges of the impermeable material); and
a chamber (or cup receptacle, 39 Col. 5 lines 65-68) positioned at least partially between the first region and the second region of the impermeable material (see figure 4 and annotated figure below), the chamber being positioned between and defined by a portion of the second layer of permeable material and at least some of the impermeable material (see figure 4 and Col 5 lines 65-68, which shows a chamber of void space between and defined by the permeable material and the impermeable material); a receptacle opening in the impermeable material (opening 24 in figure 2 and 4); and
a port extending through the impermeable material to the chamber, the port being configured to transport urine from the chamber through the port (Figure 4 and Col 5 line 62 – Col 6 line 21 discloses a port or drainage outlet 38 extending from the impermeable material to the chamber that allow for the removal of urine from the chamber).
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Washington fails to disclose wherein the top portion of impermeable material positioned about the receptacle opening is shaped such that, a profile of the top portion of the impermeable material from a top view that narrows beyond the opening and the receptacle opening including a length and a width size and dimensions to receive at least a head of a penis of a male and retain the head of the penis disposed in the receptacle when the male is lying on his back such that the urine discharged from the head of the penis flows through the first layer of permeable material and the second layer of permeable material into the chamber when a partial vacuum is applied to the port and that the second layer of the permeable material is different from the first.
While Washington teaches a device shaped to surround and cover the female labia, the opening is similar shaped to the penis. Therefore, the device of Washington is interpreted to be fully capable of functioning as claimed and receiving at least the head of the penis of a user, where, for patentability, the functions of apparatus claims do not need to be taught by the prior art, but only have to have structures that are capable of performing the claimed function. Additionally, the opening of Washington is sized accordingly “The top opening 24 is about 1 inch (2.5 cm) wide and 3 1/4 inch (8.3 cm) long with about a 1 inch (2.5 cm) narrow slot 26 at one end for ease in inserting or removing an insert.” Col 11 line 68- Col. 12 line 4. According to the study by Di Mauro The average penis is 7-15cm* depending on erection status this translates to 2.76 – 5.91 inches in length as such the device of Washington should fit easily fit the tip of the penis from a length perspective. The width of Washington is about 1 inch or 2.5cm. The above study only provides the circumference of the penis. If the diameter is considered a suitable estimation for the width, the width can be calculated by the following modifying formula to find the circumference or girth: circumference = diameter* pi or simply put D=C/π.
The girth ranges from 7-15cm* which equates to a diameter (or width) of 2.23- 4.77cm (0.88- 1.88 inches) which falls into the approximate opening dimension of Washington. As such while not designed for males the opening is still sized for some males.
*The date is pulled from tables 2-4 which breaks down the measures based on geographical location.
MPEP 2114 discuses functional language and notes “[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)”. In short applicant’s functional limitation for the device to be sized for a male is still met even though Washington is designed to be used for a female as the opening does not prevent some men from using the device based on the evidence above and all the structural limitations are met as modified in the rejection below.
While Washington teaches a device shaped to surround and cover the female labia, the opening is similarly shaped to the penis. Therefore, the device of Washington is interpreted to be fully capable of functioning as claimed and receiving at least the head of the penis of a user, where, for patentability, the functions of apparatus claims do not need to be taught by the prior art, but only have to have structures that are capable of performing the claimed function.
Additionally, Keane teaches a urinary device there by being in the same field of endeavor as Washington. Keane teaches that the device, as a whole, narrows along the top view at least partially along the opening and continues to narrow beyond the opening as illustrated in the figure 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the shape of the device according to Washington such that it narrows beyond the opening as taught by Keane, and one skill would have been motivated to do so, in order to provide improved fit. Furthermore, changing the shape to a known configuration as taught by Keane can be obtained by one of ordinay skill with a reasonable expectation of success as an obvious design choice. The courts have held that the configuration or shape was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant; In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) MPEP 2144.04 IV.
Washington fails to disclose wherein the second layer of permeable material different than the first layer of permeable material.
Kuntz teaches a urine collect device being in the same field of endeavor as Washington. Kuntz teaches wherein the first layer of permeable material includes a wicking material to help the user feel dry Col 4 lines 48-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added a layer of wicking material to the device of Washington to help improve the user’s sensation of dryness as taught by Kuntz. Thus modified Washington would have two distinct permeable material layers.
With regards to claim 10, Washington discloses a receptacle defined at least partially by the first layer of permeable material (or inside cavity 56, figure 2 and 4 that is defined by a first layer of the permeable material). Washington discloses the urine flowing through the first and second layer prior to entering the chamber (insert 46, figure 1 is noted as a fluid permeable insert that is multi-layered Col 6 lines 21-38 and figure 4). Therefore, while not intended, the device of Washington is interpreted to be fully capable of functioning as claimed and receiving at least the head of the penis of a user.
With regards to claim 12, Washington discloses a portion of the first layer of permeable material is positioned opposite to the receptacle opening and adjacent to the portion of the second layer of permeable material defining the chamber (see figure 4 which shows the permeable material opposite the chamber).
With regards to claim 13, Washington discloses the impermeable material includes a lip (29 and 31, figure 1) at least partially surrounding the receptacle opening (Col. 5 lines 36-40).
With regards to claim 23, Washington clearly discloses the receptacle opening includes a first end region having a first maximum width and a second end region having a second maximum width less than the first maximum width of the first end region (see figure 3 and where the opening narrows at one end).
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Washington US 4886508 and evidenced by Peterson US 5246454 and Di Mauro M, Tonioni C, Cocci A, Kluth LA, Russo GI, Gomez Rivas J, Cacciamani G, Cito G, Morelli G, Polloni G, di Maida F, Giunti D; Trauma, Reconstructive Urology, Men’s Health Working Parties of the European Association of Urology (EAU) Young Academic Urologists (YAU). Penile length and circumference dimensions: A large study in young Italian men. Andrologia. 2021 Jul;53(6):e14053. doi: 10.1111/and.14053. Epub 2021 Mar 21. PMID: 33748967; PMCID: PMC8243978 (here after referred to as Di Mauro) in view of Keane US 3349768.
With regards to claim 16, Washington discloses a urine collecting device (abstract) comprising: an impermeable material (discloses the body 12, figure 1 is formed from silicone rubber Col 8 lines 46-48, Peterson is used as evidence that silicone rubber is impermeable Peterson Col 1 lines 16-18) including a first region and a second region generally opposite to the first region (see annotated figure above in claim 9), the first and second region being secured together at opposing lateral edges (see figure below, and Col 2 lines 40-51 which body (or impermeable material) has a top, bottom (or first and second region) and side walls that are able to be deformed and return to their original shape resulting in container that functions as unit);
one or more layers of permeable material (insert 46, figure 1 is noted as a fluid permeable insert that is multi-layered Col 6 lines 21-38) positioned at least partially between the first surface and the second surface (see figure 4) at least one or more layer of permeable material having terminating edges positioned at least proximate to the opposing lateral edges of the impermeable material (Col 2 lines 24-39 which note the insert (or permeable material) contacts the side walls or lateral edges of the impermeable material);
a port extending through the impermeable material to the chamber, the port being configured to transport urine from the chamber through the port (Figure 4 and Col 5 line 62 – Col 6 line 21 discloses a port or drainage outlet 38 extending from the impermeable material to the chamber that allow for the removal of urine from the chamber);
an receptacle opening (24, figure 1) in the first surface of the impermeable material of the urine collection device distal to the port (see opening 24 in figure 4 as annotated above in claim 9); a receptacle of void space (or inside cavity 56, figures 2 and 4) extending into the urine collection device from the receptacle opening and defined at least partially by the impermeable material and at least one layer of permeable material of the one or more layers of permeable material (figure 2 and 4 that is defined by a first layer of the permeable material and impermeable material).
Washington fails to disclose wherein the top portion of impermeable material positioned about the receptacle opening is shaped such that, a profile of the top portion of the impermeable material from a top view that narrows beyond the opening and the receptacle opening including a length and a width size and dimensions to receive at least a head of a penis of a male and retain the head of the penis disposed in the receptacle when the male is lying on his back such that the urine discharged from the head of the penis flows through the first layer of permeable material and the second layer of permeable material into the chamber when a partial vacuum is applied to the port, and that the at least one layer of the one or more layers of permeable material includes a polyester material.
While Washington teaches a device shaped to surround and cover the female labia, the opening is similar shaped to the penis. Therefore, the device of Washington is interpreted to be fully capable of functioning as claimed and receiving at least the head of the penis of a user, where, for patentability, the functions of apparatus claims do not need to be taught by the prior art, but only have to have structures that are capable of performing the claimed function. Additionally, the opening of Washington is sized accordingly “The top opening 24 is about 1 inch (2.5 cm) wide and 3 1/4 inch (8.3 cm) long with about a 1 inch (2.5 cm) narrow slot 26 at one end for ease in inserting or removing an insert.” Col 11 line 68- Col. 12 line 4. According to the study by Di Mauro the average penis is 7-15cm* depending on erection status this translates to 2.76 – 5.91 inches in length as such the device of Washington should fit easily fit the tip of the penis from a length perspective. The width of Washington is about 1 inch or 2.5cm. The above study only provides the circumference of the penis. If the diameter is considered a suitable estimation for the width, the width can be calculated by the following modifying formula to find the circumference or girth: circumference = diameter* pi or simply put D=C/π.
The girth ranges from 7-15cm* which equates to a diameter (or width) of 2.23- 4.77cm (0.88- 1.88 inches) which falls into the approximate opening dimension of Washington. As such while not designed for males the opening is still sized for some males.
*The date is pulled from tables 2-4 which breaks down the measures based on geographical location.
MPEP 2114 discuses functional language and notes “[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)”. In short applicant’s functional limitation for the device to be sized for a male is still met even though Washington is designed to be used for a female as the opening does not prevent some men from using the device based on the evidence above and all the structural limitations are met as modified in the rejection below.
Washington also fails to disclose the opening being sized and dimensioned to receive at least a head of a penis of a man and the receptacle being shaped to receive at least the head of the penis inserted through the opening, wherein the receptacle is configured to draw urine flowing from the head of the penis through the one or more layers of permeable material to the port when the head of the penis is disposed within the receptacle when the man is lying on his back.
While Washington teaches a device shaped to surround and cover the female labia, the opening is similar shaped to the penis. Therefore, while not intended, the device of Washington is interpreted to be fully capable of functioning as claimed and receiving at least the head of the penis of a user.
Keane teaches a urinary device there by being in the same field of endeavor as Washington. Keane teaches the device as a whole narrow along the top view at least partially along the opening and continues to narrow beyond the opening as illustrated in the figure 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the shape of the device according to Washington such that it narrows beyond the opening as taught by Keane, and one skill would have been motivated to do so, in order to provide improved fit. Furthermore, changing the shape to a known configuration as taught by Keane can be obtained by one of ordinay skill with a reasonable expectation of success as an obvious design choice. The courts have held that the configuration or shape was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant; In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) MPEP 2144.04 IV.
With regards to claim 17, Washington discloses a chamber of void space (or cup receptacle, 39 Col. 5 lines 65-68, figure 4) extending into the urine collection device from the opening and defined at least partially by the impermeable material and at least one layer of permeable material of the one or more layers of permeable material (see figure 4 and Col 5 lines 65-68, which shows a chamber of void space between and defined by the permeable material and impermeable material) and wherein the chamber is positioned at least partially within a concave portion of the impermeable material (see cross section of the body in figure 2 showing a curved body).
With regards to claim 18, Washington discloses a chamber of void space (or cup receptacle, 39 Col. 5 lines 65-68, figure 4) extending into the urine collection device from the opening and defined at least partially by the impermeable material and at least one layer of permeable material of the one or more layers of permeable material (see figure 4 and Col 5 lines 65-68, which shows a chamber of void space between and defined by the permeable material and impermeable material) the chamber is void space positioned between the portion of the at least one layer of permeable material and the portion of the impermeable material defining the chamber (see figure 4 showing the void space therebetween).
With regards to claim 19, Washington discloses the receptacle opening extends through the impermeable material that is positioned generally opposite to the port (see figure 1 and 4) and the receptacle is defined at least partially by two opposing portions of the one or more layers of permeable material (see cross section in figure 2 which shows the receptacle is defined by the permeable material and Col. 6 lines 21-38 which notes a multilayer permeable material).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Washington US 4886508 and evidenced by Peterson US 5246454 and Di Mauro M, Tonioni C, Cocci A, Kluth LA, Russo GI, Gomez Rivas J, Cacciamani G, Cito G, Morelli G, Polloni G, di Maida F, Giunti D; Trauma, Reconstructive Urology, Men’s Health Working Parties of the European Association of Urology (EAU) Young Academic Urologists (YAU). Penile length and circumference dimensions: A large study in young Italian men. Andrologia. 2021 Jul;53(6):e14053. doi: 10.1111/and.14053. Epub 2021 Mar 21. PMID: 33748967; PMCID: PMC8243978 (here after referred to as Di Mauro) in view of Keane US 3349768 and in further view of Kuntz US 4747166.
With regards to claim 20, Washington discloses a chamber of void space (or cup receptacle, 39 Col. 5 lines 65-68, figure 4) extending into the urine collection device from the opening and defined at least partially by the impermeable material and at least one layer of permeable material of the one or more layers of permeable material (see figure 4 and Col 5 lines 65-68, which shows a chamber of void space between and defined by the permeable material and impermeable material);
wherein the one or more layers of permeable material include a first layer of permeable material having opposing first terminating edges positioned at least proximate to the opposing lateral edges of the impermeable material (Col 2 lines 24-39 which note the insert (or permeable material) contacts the side walls or lateral edges of the impermeable material);
a second layer of permeable material positioned between the first layer of permeable and the chamber (insert 46, figure 1 is noted as a fluid permeable insert that is multi-layered Col 6 lines 21-38) having opposing second terminating edges positioned at least proximate to the opposing lateral edges of the impermeable material and the first terminating edges of the first layer of permeable material (Col 2 lines 24-39 which note the multi-layered insert (or permeable material) contacts the side walls or lateral edges of the impermeable material);
Washington fails to disclose wherein the second layer of permeable material different than the first layer of permeable material.
Kuntz teaches a urine collect device being in the same field of endeavor as Washington. Kuntz teaches wherein the first layer of permeable material includes a wicking material to help the user feel dry Col 4 lines 48-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added a layer of wicking material to the device of Washington to help improve the user’s sensation of dryness as taught by Kuntz. Thus modified Washington would have two distinct permeable material layers.
Claims 5 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Washington US 4886508 and evidenced by Peterson US 5246454 and Di Mauro M, Tonioni C, Cocci A, Kluth LA, Russo GI, Gomez Rivas J, Cacciamani G, Cito G, Morelli G, Polloni G, di Maida F, Giunti D; Trauma, Reconstructive Urology, Men’s Health Working Parties of the European Association of Urology (EAU) Young Academic Urologists (YAU). Penile length and circumference dimensions: A large study in young Italian men. Andrologia. 2021 Jul;53(6):e14053. doi: 10.1111/and.14053. Epub 2021 Mar 21. PMID: 33748967; PMCID: PMC8243978 (here after referred to as Di Mauro) in view of Kuntz US 4747166 and in further view of Wolff US 6740066 B2.
With regards to claim 5, 15, and 21, Washington fails to disclose wherein the first layer of permeable material includes a wicking material and the second layer of permeable material includes a polyester material positioned between the wicking material of the first permeable layer and the second region of the fluid impermeable material
However, Kuntz teaches a urine collect device being in the same field of endeavor as Washington. Kuntz teaches wherein the first layer of permeable material includes a wicking material to help the user feel dry Col 4 lines 48-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added a layer of wicking material to the device of Washington to help improve the user’s sensation of dryness as taught by Kuntz.
Washington and Kuntz fail to teach as modified the second layer of permeable material includes a polyester material positioned between the wicking material of the first permeable layer and the second region of the fluid impermeable material.
However, Wolff teaches a urine collection device thereby being in the same field of endeavor with three layers, one of which is a spacing layer (or porous material layer) made from polyester that is in between the wicking and impermeable layers (Col. 6: lines 14-18, Wolff teaches polyester or open cell foam/ like materials maybe used to allow fluid flow thereby implying they are porous).
It would have been obvious to one of ordinary skill in the art to have made the insert of Washington using the specific polyester material of Wolff since polyester provides comfort to the user while not obstructing the fluid flow. Additionally, the selection of a known material based on its suitability for its intended use supported a prima facie obviousness, as per In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), and also in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Washington US 4886508 and evidenced by Peterson US 5246454 and Di Mauro M, Tonioni C, Cocci A, Kluth LA, Russo GI, Gomez Rivas J, Cacciamani G, Cito G, Morelli G, Polloni G, di Maida F, Giunti D; Trauma, Reconstructive Urology, Men’s Health Working Parties of the European Association of Urology (EAU) Young Academic Urologists (YAU). Penile length and circumference dimensions: A large study in young Italian men. Andrologia. 2021 Jul;53(6):e14053. doi: 10.1111/and.14053. Epub 2021 Mar 21. PMID: 33748967; PMCID: PMC8243978 (here after referred to as Di Mauro) in view of Kuntz US 4747166 and Keane US 3349768 and in further view of Wolff US 6740066 B2.
With regards to claim 5, 15, and 21, Washington fails to disclose wherein the first layer of permeable material includes a wicking material and the second layer of permeable material includes a polyester material positioned between the wicking material of the first permeable layer and the second region of the fluid impermeable material
However, Kuntz teaches a urine collect device being in the same field of endeavor as Washington. Kuntz teaches wherein the first layer of permeable material includes a wicking material to help the user feel dry Col 4 lines 48-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added a layer of wicking material to the device of Washington to help improve the user’s sensation of dryness as taught by Kuntz.
Washington and Kuntz fail to teach as modified the second layer of permeable material includes a polyester material positioned between the wicking material of the first permeable layer and the second region of the fluid impermeable material.
However, Wolff teaches a urine collection device thereby being in the same field of endeavor with three layers, one of which is a spacing layer (or porous material layer) made from polyester that is in between the wicking and impermeable layers (Col. 6: lines 14-18, Wolff teaches polyester or open cell foam/ like materials maybe used to allow fluid flow thereby implying they are porous).
It would have been obvious to one of ordinary skill in the art to have made the insert of Washington using the specific polyester material of Wolff since polyester provides comfort to the user while not obstructing the fluid flow. Additionally, the selection of a known material based on its suitability for its intended use supported a prima facie obviousness, as per In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), and also in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Suzuki US 7220250 B2 discloses a multi-layer urine vacuum device that has a chamber filled with a spacer to prevent collapse of the chamber, while not directly related because of the spacer within the chamber, the layers and function is pertinent.
Lawrence US 5678564 discloses a multi-layer urine vacuum device with a chamber having a void but is specified for females instead of males.
SU 2018/0200101 A1 discloses urine collection device without a second porous material layer.
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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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