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 in response to communications filed September 23, 2025.
Status of Claims
1. Claims 1-17, 19-24 and 29 are pending and currently under consideration for patentability.
Response to Arguments
2. Applicant’s arguments with respect to claim(s) 1 and 13 have been considered but are moot because the new ground of rejection does not rely on the same combinations of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
3. Claim 29 is objected to because of the following informalities:
Claim 29 is mistakenly given the “(Withdrawn)” claim status identifier; however, claim 29 will be interpreted as having the ---(Previously Presented)--- claim status identifier.
Appropriate correction is required.
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) 1-7 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 6,398,742) in view of Wolff et al. (US PGPUB 2002/0087131) in view of Holt (US PGPUB 2017/0354532).
5. With regard to claim 1, Kim discloses a portable urine collection system (urine discharge apparatus body, 1; abstract; Figs. 1, 5, 6, 7; col. 1, lines 12-18), comprising: a urine collection device (collection member, 6) configured to be positioned at least proximate to a urethra of a user (col. 4, lines 9-23); a first conduit (discharge pipe, 15) in fluid communication with the urine collection device (6); a separate drain or urinal (not shown) having an interior region (Fig. 7; col. 4, lines 60-65); a second conduit (auxiliary hose, 13, 13’) in fluid communication with the interior region of the separate drain or urinal (col. 5, lines 36-43); a modular pump (small pump, 5) configured to pull a vacuum and draw urine from the urine collection device (6) through the first conduit (15) and force the urine through the second conduit (13’) into the interior region of the separate drain or urinal, wherein the modular pump (5) is configured for use with a first setting when the user is in bed (Fig. 7; col. 4, lines 60-65; col. 5, lines 36-43; col. 6, lines 60-65), and wherein the modular pump (5) is removable by the user and replaceable in the portable urine collection system (1) by the user with an additional modular pump (col. 7, lines 54-67).
While Kim discloses the use of a second conduit (13, 13’) for connection to a desired separate drain or urinal (col. 5, lines 36-43), Kim fails to explicitly disclose that the second conduit is in fluid communication with an interior region of a modular urine collection bag; wherein the modular urine collection bag and the modular pump are configured for use with a first setting when the user is at least one of walking, in bed, or in a wheelchair; and a different pump and/or different urine collection bag for use with a second setting different than the first setting and when the user is at least one of walking, in the bed, or in the wheelchair.
However, Wolff discloses a urine collection device (abstract; Figs. 1, 3, 4), comprising: a urine collection device (layered female interface, 27) configured to be positioned proximate to a urethra of a user (Figs. 5a, 5b; [0045]); a modular urine collection bag (bag, 2 within container, 1) having an interior region; and a pump (4) configured to pull a vacuum and draw urine from the urine collection device through a first conduit (6) and force the urine into the interior region of the urine collection bag (2; [0027]); wherein the urine collection bag (2) and the pump (4) are configured for use with a first setting when the user is in a wheelchair ([0021]; [0034]; Figs. 1, 2); and a different pump (lighter pump, 26) and/or different modular urine collection bag (ovoid container, 25) for use with a second setting different than the first setting (Fig. 4) and when the user is walking ([0037-0039]).
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 portable urine collection system disclosed by Kim to include a urine collection bag and pump connectable to the system depending on whether the patient is walking or in a wheelchair, similar to that disclosed by Wolff, in order to accommodate individuals that may be confined to a wheelchair, who can have storage and pumping systems behind or under the wheelchair, as well as individuals that are ambulant/mobile, more self-sufficient or have good upper body mobility, who can carry the storage and pumping systems in a bag around the waist, as suggested by Wolff in paragraphs [0021], [0034] and [0037]. Further, such urine collection bags are well-known and widely-utilized in the art, and would be obvious to utilize with a reasonable expectation of success.
Further, while Kim discloses that the conduits (13, 15) are removable and the modular pump (5) is removable by the user and replaceable in the portable urine collection system (1) by the user with an additional modular pump (col. 7, lines 54-67); and Wolff discloses an inlet (9) and outlet (20) having press-fit connections to tubing (6; Figs. 1, 2, 4; [0028]; [0031]); Kim and Wolff fail to explicitly disclose that each of the different modular pumps and modular urine collection bags include universal connectors configured to enable the pumps and bags to be removable and replaceable by the user.
Holt discloses a male catheter (100; abstract; Fig. 1) comprising a urine collection device (sheath portion, 102) and a conduit (tube, 114) having a distal universal connection portion (118; [0023]) for connection to a leg bag application or for connection to a collection bag attached to the patient’s bed or wheelchair ([0007]; [0019]; [0022]).
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 modular pumps and urine collection bags disclosed by Kim in view of Wolff to include universal connectors, similar to that disclosed by Holt, in order to accommodate well-known and universally used hose couplings, for ease of connection of the system to drainage bags in wheelchair or bedridden settings and to leg bags in ambulatory settings, as suggested by Holt in paragraphs [0019] and [0022-0023].
6. With regard to claim 2, Kim discloses that the modular pump (5) includes a disposable modular pump (5) removably connected to the first conduit (15) and the second conduit (13’; Figs. 1, 5, 6, 7; col. 7, lines 54-67).
7. With regard to claim 3, while Kim discloses a small modular pump (5; col. 1, lines 12-18), Kim, Wolff and Holt fail to explicitly disclose that the disposable modular pump has a height of less than about 1.25 cm, a width of less than about 1.25 cm, and a depth of less than about 0.75 cm.
However, 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 dimensions of the small modular pump disclosed by Kim in view of Wolff and Holt to have a height of less than about 1.25 cm, a width of less than about 1.25 cm, and a depth of less than about 0.75 cm, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A). In the instant case, one having ordinary skill in the art would select a small modular pump with a height, width and depth to perform the desired function of portably collecting urine.
8. With regard to claim 4, while Kim discloses that the urine collection device (6) includes one or more urinalysis test strips (test paper, 16; abstract; Fig. 1) in order to test for the presence of a proteinuira, haematouria, glycosuria or pregnancy (col. 4, lines 51-54), Kim, Wolff and Holt fail to explicitly disclose that the urine collection bag includes one or more test strips.
However, 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 urine collection bag disclosed by Kim in view of Wolff and Holt to include a urinalysis test strip, similar to that disclosed by Kim, in order to simultaneously test for the presence of a proteinuira, haematouria, glycosuria or pregnancy during use of the device, as suggested by Kim in column 4, lines 51-54.
9. With regard to claim 5, Kim discloses a battery (battery case, 4) removably connected to the modular pump (5; Fig. 1; col. 3, lines 50 – col. 4, line 4).
10. With regard to claim 6, Kim, as modified by Bennett above, discloses that the pump (5), the battery (4), and the fluid collection bag (as modified by Bennett) are sized and dimensioned to be simultaneously carried by the user when the urine collection device is positioned at least proximate to the urethra of the user (col. 1, lines 12-18).
11. With regard to claim 7, Kim discloses that the pump (5) and the power supply (4) are sized and dimensioned to be detachably secured proximate to a waist of the user and the urine collection bag is sized and dimensioned to be positioned within a pocket of a leg sleeve worn on the leg of the user (col. 1, lines 12-18 and 39-55).
12. With regard to claim 24, Kim in view of Wolff discloses the method disclosed in claim 13, as seen below; however, while Wolff discloses inserting/securing the pump (26) into a pack/proximate to the waist of the user while using the device in an walking setting (waist worn bag; [0037-0039]), and while leg sleeves are well-known in the art for accommodating urine collection bags, Kim and Wolff are silent in regard to inserting the urine collection bag and/or the different urine election bag into a pocket of a leg sleeve worn by the user.
Holt discloses Holt discloses a male catheter (100; abstract; Fig. 1) comprising a urine collection device (sheath portion, 102) and a conduit (tube, 114) having a distal universal connection portion (118; [0023]) for connection to a leg bag application ([0007]; [0019]; [0022]).
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 method disclosed by Kim in view of Wolff to include a step of inserting the collection bag into a pocket of a leg sleeve, similar to that disclosed by Holt, in order to utilize well-known urinary collection bag leg sleeves which act to stabilize, support and conceal the urinary collection bag during use, as suggested by Holt in paragraphs [0019] and [0022-0023].
13. Claim(s) 13-17 and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Wolff.
14. With regard to claims 13-15, 19 and 22-23, Kim discloses method of assembling a portable urine collection system (urine discharge apparatus body, 1; abstract; Figs. 1, 5, 6, 7; col. 1, lines 12-18; col. 5, lines 1-42), the method comprising: connecting a first conduit (15) to a urine collection device (6) to provide fluid communication between the urine collection device (6) and the first conduit (15; col. 4, lines 24-31); connecting a second conduit (13, 13’) to a desired separate drain or urinal to provide fluid communication between the second conduit and the separate drain or urinal (col. 5, lines 36-43); connecting a modular pump (5) to the first conduit (15) and the second conduit (13), the modular pump (5) configured to pull a vacuum and draw urine from the urine collection device (6) through the first conduit and force the urine through the second conduit into the separate drain or urinal when a user is in a first setting, in a bed (Fig. 7; col. 4, lines 60-65; col. 5, lines 36-43; col. 6, lines 60-65); and after collecting at least some urine from the urine collection device positioned at least proximate to a urethra of a user (col. 3, lines 21 – col. 4, line 32), removing, by the user, the modular pump (5) and replacing, by the user, at least the modular pump with a different pump (col. 6, lines 47 – col. 7, line 14; col. 7, lines 54-67).
While Kim discloses the use of a second conduit (13, 13’) for connection to a desired separate drain or urinal (col. 5, lines 36-43), Kim fails to explicitly disclose connecting the second conduit in fluid communication with an interior region of a urine collection bag; removing/disconnecting and replacing, by the user, the modular pump and urine collection bag with a different pump and different urine collection bag for use with a second setting different than the first setting and when the user is at least one of walking, in the bed, or in the wheelchair; and inserting/securing the modular pump into a backpack/proximate to the waist of the user.
However, Wolff discloses a urine collection device/method (abstract; Figs. 1, 3, 4), comprising: a urine collection device (layered female interface, 27) configured to be positioned proximate to a urethra of a user (Figs. 5a, 5b; [0045]); a modular urine collection bag (bag, 2 within container, 1) having an interior region; and a pump (4) configured to pull a vacuum and draw urine from the urine collection device through a first conduit (6) and force the urine into the interior region of the urine collection bag (2; [0027]); wherein the urine collection bag (2) and the pump (4) are configured to be connected/disconnected for use with a first setting when the user is in a wheelchair ([0021]; [0034]; Figs. 1, 2); and a different pump (lighter pump, 26) and/or different modular urine collection bag (ovoid container, 25) connected/disconnected for use with a second setting different than the first setting (Fig. 4) and when the user is walking, inserting/securing the pump (26) into a pack/proximate to the waist of the user (waist worn bag; [0037-0039]).
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 method of assembling the portable urine collection system disclosed by Kim to include the step of connecting/disconnecting a urine collection bag and pump to the system depending on whether the patient is walking or in a wheelchair, similar to that disclosed by Wolff, in order to accommodate individuals that may be confined to a wheelchair, who can have storage and pumping systems behind or under the wheelchair, as well as individuals that are ambulant/mobile, more self-sufficient or have good upper body mobility, who can carry the storage and pumping systems in a bag around the waist, as suggested by Wolff in paragraphs [0021], [0034] and [0037]. Further, such urine collection bags are well-known and widely-utilized in the art, and would be obvious to utilize with a reasonable expectation of success.
15. With regard to claims 16-17, while Kim discloses removing, by the user, the modular pump (5) and replacing, by the user, at least the modular pump with a different pump (col. 6, lines 47 – col. 7, line 14; col. 7, lines 54-67), Kim shows an exploded view of individual components of the system including modular first/second conduits (15, 13; Fig. 1), and Kim in view of Wolff disclose the claimed disconnection/connection of different urine collection bags depending on the setting (see rejection above), Kim and Wolff fail to explicitly disclose disconnecting, by the user, the first/second conduit, from the modular pump and connecting, by the user, a different first/second conduit to the modular pump or different modular pump.
However, 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 method of assembling the portable urine collection system disclosed by Kim in view of Wolff to include the method steps of removing/replacing the first and second conduits of the system, similar to the modular pump replacement disclosed by Kim, in order to allow for possible disinfecting and replacement for subsequent use, as suggested by Kim in column 7, lines 54-67.
16. With regard to claim 20, Kim discloses disconnecting a battery (battery case, 4) from the modular pump (5) and connecting a different battery to the modular pump (5; Fig. 1; col. 3, lines 21-42; col. 5, lines 1-18; col. 8, lines 5-10).
17. With regard to claim 21, while Kim discloses that the urine collection device (6) includes one or more urinalysis test strips (test paper, 16; abstract; Fig. 1) in order to test for the presence of a proteinuira, haematouria, glycosuria or pregnancy (col. 4, lines 51-54), Kim and Wolff fail to explicitly disclose testing urine collected in the urine collection bag with one or more urinalysis test strips attached to the urine collection bag.
However, 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 method disclosed by Kim in view of Wolff to include test the urine within the collection bag with a urinalysis test strip, similar to that disclosed by Kim, in order to simultaneously test for the presence of a proteinuira, haematouria, glycosuria or pregnancy during use of the device, as suggested by Kim in column 4, lines 51-54.
Allowable Subject Matter
18. Claims 8-12 and 29 remain objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, as stated in the April 24, 2025 Non-Final Office action.
Conclusion
19. 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.
20. 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..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (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