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 .
Response to Amendment
In the reply filed 5/13/2026, applicant amended claims 1, 3, 9, 10, 16, 19, 20, and 24. Claims 1-5, 6-20, and 22-29 are currently pending, and claims 16-20 and 22-29 are withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4 and 6-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejection below has been updated in view of newly considered prior art. See the updated rejection below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6-11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Birbara et al. (US 2012/0066825) in view of Norton (US 4,512,771).
With respect to Claim 1, Birbara teaches a portable urine collection system 10 (Figures 1-9), comprising:
a urine collection device 124 configured to be positioned at least proximate to a urethra of a user (Figures 1-2; paragraph [0024]);
a conduit (146, 144, and 147) in fluid communication with the urine collection device 124 (Figures 2, 3, and 5; paragraph [0027]),
a urine collection container 130 that is generally rigid (paragraph [0026]) and has an interior region and a port (covered by reservoir cap 152) in fluid communication with the interior region (Figures 3 and 5; paragraphs [0025-0029] and [0040]), the conduit 146 being secured to the port 152 and in fluid communication with the interior region through the port 152 (paragraphs [0025-0029]; Figures 1-9);
a pump 142 secured or securable to the urine collection container 130 and configured to promote urine from the urine collection device 124 through the conduit 144 into the urine collection container (paragraphs [0023], [0027-0028], and [0040]; Figures 1-9);
an exhaust vent 155 (Figures 3 and 5; paragraphs [0025-0028]) on the urine collection container configured to allow air from the urine collection container to exit through the exhaust vent 155 (air passes through the exhaust vent and through conduit sections 144 and 147 to be discharged (Figures 3 and 5; paragraphs [0025-0028]); and
a sensor 153 secured or securable to the container 130 and configured to detect a property relating at least to a volume of the urine in the urine collection container 130 (Figure 6; paragraphs [0057-0058]).
Birbara does not specifically teach that the exhaust vent 155 includes a hydrophobic filter configured to allow air to escape through the exhaust vent while inhibiting urine from exiting through the exhaust vent. However, Norton teaches a venting assembly for use with a urine collection container (Column 1, Lines 14-24), the venting assembly being disposed on the upper portion of the container (Column 2, Lines 3-8) comprising a hydrophobic membrane that is configured to prevent the passage of liquid from the interior of the container while allowing air to escape (Column 1, Lines 50-65; Column 3, Lines 28-40). Additionally, the hydrophobic filter prevents the ingress of bacteria into the container (Abstract; Column 1, Line 50 through Column 2, Line 8). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Birbara’s urine collection container to include an exhaust vent having a hydrophobic filter, as suggested by Norton, in order to provide an art-established means for allowing air to be vented to/from the container while preventing the escape of urine and the passage of bacteria
With respect to Claim 2, Birbara further teaches a battery 180 operable coupled to the pump (Figures 2-3; paragraph [0037]).
With respect to Claim 3, Birbara teaches that the pump 142 is disposed without the portable housing 1410 of the portable urine collection system (Figures 2-3; paragraphs [0023] and [0027-0028]), The pump is therefore a portable pump.
With respect to Claim 4, Birbara teaches that the pump 142 is secured indirectly to the urine collection container 130 between a portion of the conduit (147) and the urine collection container 130. See Figure 3.
With respect to Claim 6, Birbara teaches that the pump 142 is indirectly securable to the urine collection container 130 and the conduit (146, 144, 147) is securable to the urine collection container 130 and configured to pull at least a partial vacuum on the urine collection container 130 effective to pull at least a partial vacuum on the conduit and pull urine from the urine collection device through the conduit 146 and into the interior region of the urine collection container (paragraphs [0023], [0027-0028], and [0040]; Figures 1-9).
In the event that Applicant does not clearly envisage Birbara’s pump and conduit as being secured or securable to the urine collection container, it has been held that the mere rearrangement of parts does not constitute a patentable improvement in the art when said rearrangement does not result in a nonobvious change in functionality (MPEP 2144.04 VI. C.). In this case, it is unclear why positioning the pump and conduit such that they are secured or securable to the collection container 130 as opposed to adjacent collection container 130 would result in a non-obvious change in functionality of the device. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Birbara’s urine collection system to have the pump and conduit secured to or securable to the collection container, or in any other configuration that was considered desirable or expedient, because it has been held that rearranging parts of an invention involves only routine skill.
With respect to Claim 7, Birbara teaches that the urine collection container 130 is generally rectangular and includes an upper surface (shown in Figure 5-6) and a neck protruding from the upper surface (the neck includes porty 152; Figures 3-5).
While Birbara teaches that the battery and pump are positionable adjacent the upper surface of the urine collection container, it does not explicitly teach that the battery and pump are positionable on the upper surface of the urine collection container.
However, it has been held that the mere rearrangement of parts does not constitute a patentable improvement in the art when said rearrangement does not result in a nonobvious change in functionality (MPEP 2144.04 VI. C.). In this case, it is unclear why positioning the pump and battery on the upper surface of the collection container 130 as opposed to adjacent the upper surface of the collection container 130 would result in a non-obvious change in functionality of the device. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Birbara’s urine collection system to have the pump and battery on the upper surface of the collection container, or in any other location that was considered desirable or expedient, because it has been held that rearranging parts of an invention involves only routine skill.
With respect to Claim 8, Birbara teaches that the urine collection container 130, the battery 180, and the pump 142 together form a generally rectangular profile. Specifically, as seen in Figures 1-4, the collection container, battery, and pump are disposed in a generally rectangular profile to be enclosed within a generally rectangular housing 112.
With respect to Claim 9, Birbara is silent as to the specific dimensions of the rectangular housing of the device. However, has been held that mere changes in size or proportion do not constitute patentable improvements in the art when said changes do not result in a non-obvious change in functionality (MPEP § 2144.04.IV.A.). In this case, Birbara discloses that the system is designed to be portable (see Abstract and paragraph [0009]. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Birbara’s urine collection system such that the rectangular housing has a height of 15.2-45.7 cm, a width of 15.2-45.7 cm, and a depth of 2.5-15.2 cm, or any other size that was considered desirable or expedient for a given application, since a change in proportion is generally recognized as being within the level of ordinary skill in the art.
With respect to Claim 10, Birbara teaches that the exhaust vent 155 is disposed on the neck portion 152 near the top of the urine collection container 130 (Figures 2-6; paragraphs [0025-0028]).
With respect to Claim 11, Birbara teaches that the sensor 153 may be a level sensor that determines when the collection container 130 is full (paragraphs [0057-0058]; see), but is silent regarding the exact location of the sensor on the collection container. The sensor is positioned or positionable proximate to (i.e. near) an intersection between the upper surface and neck of the urine collection container 130 (Figure 6).
However, in the event that this interpretation is not clearly envisaged by applicant, it has been held that the mere rearrangement of parts does not constitute a patentable improvement in the art when said rearrangement does not result in a nonobvious change in functionality (MPEP 2144.04 VI. C.). In this case, Birbara teaches that the level sensor is configured to sense when the urine collection container is full (paragraphs [0057-0058]), and accordingly it would have been clear to a skilled artisan that the sensor would need to sense whether urine is present near the top of the collection container. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify Birbara’s portable urine collection system such that the sensor is positioned or positionable between or proximate to an intersection of the upper surface and neck of the bag, or in any other position where it is capable of sensing the degree of fullness of the urine collection container, since it has been held that rearranging parts of an invention involves only routine skill in the art.
With respect to Claim 15, Birbara teaches that the container and pump are sized and dimensioned such that the system is portable. While Birbara does not explicitly teach that the device is mountable within a pouch secured to the wheelchair, the examiner notes that the claim merely requires that the container and pump are sized and dimensioned such that they are capable of being mounted within a generic pouch that is attached to the wheelchair. Birbara’s system is fully capable of being mounted on a pouch on a wheelchair.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Birbara and Norton as applied to claim 1 above, and further in view of Ludin (US 2018/0280236).
With respect to Claim 12, Birbara teaches that the system further comprises a controller (printed control board 188 of the control panel 186; Figure 2; paragraph [0058]) configured to communicate with the sensor 153 and generate an alert when the property relating to at least the volume of urine detected by the sensor indicates that the volume of urine in the urine collection container has reached or exceeded a predetermined level (paragraphs [0057-0058]). .
Birbara, however, does not teach that the controller wirelessly transmits an alert to an electronic device when the sensor detects that the container has reached a predetermined volume.
Ludin teaches a urine collection system [0016] comprising a collection container 90 with a plurality of sensors 10 configured to determine a level of liquid present within the container (Figures 1-2; paragraphs [0021-0030], [0036], [0046-0048]). The sensors 10 are connected to a controller 400 that receives the sensor data [0048-0051], and the controller is connected to a transmitter [0048] that is configured to wirelessly transmit an alert to an external electronic device (specifically a nurse’s station) when the fill level exceeds a threshold (paragraphs [0059], [0069], and [0085]) to alert personnel to change the collection container [0069]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Birbara’s urine collection system such that the controller 30 wirelessly transmits an alert to an electronic device when to sensor detects that the collection container is full, as suggested by Ludin, in order ensure that the container is emptied or changed before it overflows.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Birbara and Norton as applied to claim 1 above, and further in view of Otto (US 2007/0225668).
With respect to Claims 13 and 14, Birbara does not specifically teach that the sensor includes a wet sensor or water sensor configured to detect the urine contacting the sensor (Claim 13), or an ultrasound sensor (Claim 14).
Otto teaches a similar portable urine collection system in the same field of endeavor, the urine collection system comprising a urine collection device 18, a conduit 28, and a urine collection container 26 disposed within a portable housing (Figures 13 and 26). The urine collection container 26 comprises a sensor (paragraphs [0021], [0052], [0054], and [0076]; see “bag level sensor” in Figure 32) that the sensor may be any of a variety of well-known sensor types, including inductive or capacitive sensors (which are types of wetness sensors, as per Claim 13). Alternatively, the sensor may be a reflective sensor (of which ultrasound sensors are a type, as per claim 14). See paragraphs [0021-0023], [0052], [0054], and [0076]; an exemplary list of sensors that may be used is listed in paragraph [0052].
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Birbara’s portable urine collection system such that the sensor secured to the urine collection container is a wet or water sensor (an inductive or capacitive sensor, as per Claim 13) or an ultrasound sensor (a reflective sensor, as per Claim 14), as suggested by Otto, in order to provide a well-known, alternate sensor configuration for determining the fluid level within the urine collection container for alerting the user that the container is full.
In the event that Applicant does not clearly envisage this interpretation, the examiner takes official notice that wetness sensors and ultrasonic sensors are both extraordinarily well-known types of sensors used sense the fill level of a reservoir in a medical fluid collection device. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Otto’s portable urine collection system to use a wetness sensor or ultrasonic sensor to measure the fill level of the collection container, in order to provide an alternate, art-established means for determining when the collection chamber is full.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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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/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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