DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is made in response to communications filed January 21, 2026.
Status of Claims
1. Claims 2-21 are pending and currently under consideration for patentability.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on January 21, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 2-21 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
As agreed upon in the applicant initiated interview dated January 21, 2026, Harvie fails to explicitly disclose the fluid permeable membrane is positioned to contact at least a portion of the head of the penis, as presently required in amended claims 2 and 13, and therefore Harvie no longer anticipates the instant claims. In view of further search and consideration, necessitated by amendment, Kubo (US 5,300,052) is introduced as a secondary reference in curing the deficiencies Harvie. Harvie is maintained as the primary reference of rejection for disclosing a majority of the claimed structure.
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.
4. Claim(s) 2-8, 10-16, 18 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Harvie (US PGPUB 2005/0119630) in view of Kubo (US 5,300,052).
5. With regard to claims 2 and 13, Harvie discloses a fluid collection system (abstract; Figs. 4, 5, 6), comprising: a fluid collection device (male cup, 57; Figs. 4, 5) including: a fluid impermeable layer (moisture-proof outer layer, 45M) having a first portion (portion including facing layer, 39M) and a second portion (portion including suction hose, 13) generally opposite to the first portion (Fig. 5), the first portion of the fluid impermeable layer at least partially defining an opening (opening covered by isolation membrane, 50) sized and dimensioned to receive at least a head of a penis of a person ([0117]), the fluid impermeable layer forming an interior region (inside cup area, 53M) of the fluid collection device ([0116]); a fluid permeable membrane (wicking layer, 41M) disposed in the interior region (53M) of the fluid collection device between the first portion and the second portion of the fluid impermeable layer (Fig. 5; [0116]); an outlet (at connection to suction hose, 13) in the fluid impermeable layer, the outlet being configured to enable fluid in the interior region of the fluid collection device to be transported away from the fluid collection device ([0118]; Fig. 5); and a receptacle (urine cavity, 56) extending into the interior region of the fluid collection device from the opening and defined at least partially by the first portion (at 50) of the fluid impermeable layer and the fluid permeable membrane (41M), the receptacle (56) being shaped to receive at least the head of the penis inserted through the opening ([0117]; [0025]); and a vacuum source (air pump, 1A; Figs. 4, 6) fluidically coupled to the outlet (via 13; [0136]; [0149]).
While Harvie shows the fluid permeable membrane (41M; Fig. 5) in a position fully capable of contacting at least a portion of the head of the penis, since the isolation membrane (50) keeps the man’s penis inside the inner cup area (53M; [0117]), Harvie fails to explicitly disclose that the fluid permeable membrane is positioned to contact at least a portion of the head of the penis.
However, within the same field of endeavor, Kubo discloses a urinary collector for men (abstract; Figs. 1a, 2a, 4), comprising: a fluid impermeable layer (urinary collector body, 1); a fluid permeable membrane (water permeable membrane, 7) disposed in an interior region of the fluid collection device (1) and positioned to contact at least a portion of the head of the penis (see Fig. 4; Fig. 4); an outlet (urinary drainage outlet, 11) in the fluid impermeable layer (5); and a receptacle (penis receiving chamber, 6) extending into the interior region of the fluid collection device from an opening (3) defined partially by the fluid impermeable layer and the fluid permeable membrane (7; col. 3, line 53 - col. 4, line 59; col. 6, line 15-68).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the positioning of the fluid permeable membrane disclosed by Harvie to be positioned to contact at least a portion of the head of the penis, similar to that disclosed by Kubo, in order to provide a separation between the penis receiving chamber and the urine receiving chamber and facilitate the prompt wicking and downward flow of the urine through the urinary flow chamber without backward flowing of the urine to the penis receiving chamber, as suggested by Kubo in column 4, lines 10-16 column 6, lines 60-50.
6. With regard to claims 3 and 15, Harvie discloses that the receptacle (56) is configured to and fully capable of drawing fluid flowing from the head of the penis through the permeable membrane (41M) to the outlet when the penis disposed within the receptacle when the man is lying on his back (‘bedridden’; [0123]; [0143]; [0152]), and wherein the fluid permeable membrane (41M) at least partially defines the opening (Fig. 5; opening formed by 46M, 50, and 41M; [0025]; [0117]).
7. With regard to claim 4, Harvie discloses that the receptacle (56) is a void space between the first portion of the fluid impermeable layer (at 50) and the fluid permeable membrane (41M; Fig. 5; [0116]).
8. With regard to claim 5, Harvie discloses a chamber (beneath 56, defined by urine collection layer, 43M) positioned in the interior region (53M) of the fluid collection device opposite to the receptacle such that the chamber is disposed between the fluid permeable membrane and the second portion of the fluid impermeable layer (Fig. 5; [0116]).
9. With regard to claim 6, While Harvie discloses that the receptacle (56) is a void space (Fig. 5; [0116]), and that the chamber (43M) is a urine collection layer made of an open cell foam material or other material capable of collecting fluid ([0116]) positioned between the fluid permeable membrane and the second portion of the fluid impermeable layer (Fig. 5), Harvie and Kubo are silent in regard to the chamber being a void space.
Nonetheless, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the chamber disclosed by Harvie in view of Kubo to be a void space, similar to the receptacle disclosed by Harvie, in order to provide a low-cost alternative device that merely utilizes the permeable membrane between an empty receptacle and chamber to collect fluid at the lower section of the device, as suggested by Harvie in paragraph [0116], while reducing material and manufacturing costs.
10. With regard to claim 7, Harvie discloses a permeable support (urine collection layer, 43M) disposed in the interior region of the fluid collection device between the first portion and the second portion of the fluid impermeable layer (45M) opposite to the opening (Fig. 5; [0116]).
11. With regard to claim 8, Harvie is silent in regard to the permeable support including a polyester material.
However, Kubo suggests that polyester is a suitable, well-known, and widely utilized water permeable material within the art of urine collection containers (col. 5, lines 25-34).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the additional fluid permeable layer disclosed by Harvie to include polyester, similar to that suggested by Kubo, in order to utilize well known water permeable materials for assisting in the wicking away of urine from the user to the discharge area, as suggested by Kubo in column 5, lines 25-34.
12. With regard to claim 10, Harvie discloses that the opening (side including 50) includes a first semicircular region (upper region) and a second region (lower region) more narrow than the first semicircular region (Figs. 4, 5; [0116]).
13. With regard to claim 11, Harvie discloses that the second portion (side connected to 13) of the fluid impermeable layer (45M) includes a concave portion (Figs. 4, 5; [0116]).
14. With regard to claims 12, Harvie discloses that the outlet includes a tube (13) in fluid communication with the vacuum source (1A) and the receptacle (56) in the interior region (53M) of the fluid collection device and extending outward from the fluid impermeable layer (45M; Figs. 4, 5; [0118]).
15. With regard to claim 14, Harvie further discloses a fluid receptacle (urine collection bag, 3) fluidically coupled to the fluid outlet (Fig. 4; [0118]).
16. With regard to claim 18, Harvie discloses a fluid collection device (57; abstract; Figs. 4, 5, 6), comprising: a fluid impermeable barrier (45M) having an opening extending (covered by 50) therethrough, the opening being sized to receive at least a head of a penis of a person therethrough and into an interior region (53M) of the fluid collection device ([0117]); a fluid permeable material (41M) disposed in the interior region (53M) of the fluid collection device between the opening and a portion of the fluid impermeable barrier (Fig. 5; [0116]); an outlet (at connection to 13) in the fluid impermeable layer (45M), the outlet being configured to enable fluid in the interior region (53M) of the fluid collection device to be transported away from the fluid collection device ([0118]; Fig. 5); and wherein the interior region (53M) of the fluid collection device is configured to draw fluid flowing from the head of the penis through the fluid permeable material (41M) to the outlet (via 13) when the man is lying on his back (‘bedridden’; [0123]; [0143]; [0152]) and at least the head of the penis of the men is disposed at least partially in the interior region (53M) of the fluid collection device ([0117]; [0025]).
While Harvie shows the fluid permeable membrane (41M; Fig. 5) in a position fully capable of contacting at least a portion of the head of the penis, since the isolation membrane (50) keeps the man’s penis inside the inner cup area (53M; [0117]), Harvie fails to explicitly disclose that the fluid permeable membrane is positioned to contact at least a portion of the head of the penis.
However, within the same field of endeavor, Kubo discloses a urinary collector for men (abstract; Figs. 1a, 2a, 4), comprising: a fluid impermeable layer (urinary collector body, 1); a fluid permeable membrane (water permeable membrane, 7) disposed in an interior region of the fluid collection device (1) and positioned to contact at least a portion of the head of the penis (see Fig. 4; Fig. 4); an outlet (urinary drainage outlet, 11) in the fluid impermeable layer (5); and a receptacle (penis receiving chamber, 6) extending into the interior region of the fluid collection device from an opening (3) defined partially by the fluid impermeable layer and the fluid permeable membrane (7; col. 3, line 53 - col. 4, line 59; col. 6, line 15-68).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the positioning of the fluid permeable membrane disclosed by Harvie to be positioned to contact at least a portion of the head of the penis, similar to that disclosed by Kubo, in order to provide a separation between the penis receiving chamber and the urine receiving chamber and facilitate the prompt wicking and downward flow of the urine through the urinary flow chamber without backward flowing of the urine to the penis receiving chamber, as suggested by Kubo in column 4, lines 10-16 column 6, lines 60-50.
17. With regard to claim 20, Harvie discloses that the opening (side including 50) includes a first semicircular region (upper region) and a second region (lower region) more narrow than the first semicircular region (Figs. 4, 5; [0116]).
18. With regard to claims 21, Harvie discloses that the outlet includes a tube (13) in fluid communication with the interior region (53M) of the fluid collection device and extending outward from the fluid impermeable layer (45M; Figs. 4, 5; [0118]).
19. Claim(s) 9, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Harvie in view of Kubo, as applied to claims 2, 13 and 18 above, and further in view of Shelton (US PGPUB 2010/0263113 A1).
20. With regard to claim 9, Harvie is silent in regard to the permeable membrane including a fibrous polyester.
However, Kubo suggests that fibrous polyester is a suitable, well-known, and widely utilized water permeable material within the art of urine collection containers (col. 5, lines 25-34).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the permeable membrane disclosed by Harvie to include a polyester material and fibrous polyester material, respectively, similar to that suggested by Kubo, in order to utilize well known water permeable materials for assisting in the wicking away of urine from the user to the discharge area, as suggested by Kubo in column 5, lines 25-34.
Further, Harvie and Kubo fail to explicitly disclose that the permeable membrane includes a fibrous polyester material with coated fibers.
In the similar field of endeavor, Shelton discloses a urinary device (abstract; Fig. 1; [0036-0039]; [0117-0120]), which suggests the use of fibrous polyester material with coated fibers as a wicking permeable insert ([0085]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the permeable membrane disclosed by Harvie in view of Kubo to include a fibrous polyester material with coated fibers, similar to that disclosed by Shelton, in order to utilize well known water permeable materials for assisting in the wicking away and absorbance of urine from the user to the discharge area, as suggested by Shelton in paragraph [0085].
21. With regard to claim 17, Harvie discloses that the outlet includes a tube (13) in fluid communication with the vacuum source (1A) and the receptacle (56) in the interior region (53M) of the fluid collection device and extending outward from the fluid impermeable layer (45M; Figs. 4, 5; [0118]); and a permeable support (urine collection layer, 43M) disposed in the interior region of the fluid collection device between he first portion and the second portion of the fluid impermeable layer (45M; [0116]).
However, Harvie is silent in regard to the permeable support including a polyester material and the permeable membrane including a fibrous polyester material.
Kubo suggests that fibrous polyester is a suitable, well-known, and widely utilized water permeable material within the art of urine collection containers (col. 5, lines 25-34).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the permeable support and permeable membrane disclosed by Harvie to include a polyester material and fibrous polyester material, respectively, similar to that suggested by Kubo, in order to utilize well known water permeable materials for assisting in the wicking away of urine from the user to the discharge area, as suggested by Kubo in column 5, lines 25-34.
Additionally, Harvie and Kubo fail to explicitly disclose that the permeable membrane includes a fibrous polyester material with coated fibers.
In the similar field of endeavor, Shelton discloses a urinary device (abstract; Fig. 1; [0036-0039]; [0117-0120]), which suggests the use of fibrous polyester material with coated fibers as a permeable insert ([0085]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the permeable membrane disclosed by Harvie in view of Kubo to include a fibrous polyester material with coated fibers, similar to that disclosed by Shelton, in order to utilize well known water permeable materials for assisting in the wicking away and absorbance of urine from the user to the discharge area, as suggested by Shelton in paragraph [0085].
22. With regard to claim 19, Harvie discloses an additional fluid permeable material (urine collection layer, 43M) different than the fluid permeable material (41M; Fig. 5; [0116]).
However, Harvie is silent in regard to the additional fluid permeable material including a polyester material and the permeable membrane including a fibrous polyester material.
Kubo suggests that fibrous polyester is a suitable, well-known, and widely utilized water permeable material within the art of urine collection containers (col. 5, lines 25-34).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the additional fluid permeable material and permeable membrane disclosed by Harvie to include a polyester material and fibrous polyester material, respectively, similar to that suggested by Kubo, in order to utilize well known water permeable materials for assisting in the wicking away of urine from the user to the discharge area, as suggested by Kubo in column 5, lines 25-34.
Additionally, Harvie and Kubo fail to explicitly disclose that the permeable membrane includes a fibrous polyester material with coated fibers.
In the similar field of endeavor, Shelton discloses a urinary device (abstract; Fig. 1; [0036-0039]; [0117-0120]), which suggests the use of fibrous polyester material with coated fibers as a permeable insert ([0085]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the permeable membrane disclosed by Harvie in view of Kubo to include a fibrous polyester material with coated fibers, similar to that disclosed by Shelton, in order to utilize well known water permeable materials for assisting in the wicking away and absorbance of urine from the user to the discharge area, as suggested by Shelton in paragraph [0085].
Conclusion
23. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
24. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781
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