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 .
Election/Restrictions
Applicant’s election without traverse of Group I: Claims 1-15 in the reply filed on 9/24/2025 is acknowledged. Claims 16-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 9 is objected to because of the following informalities: the phrase “the generally rectangular profile of has a height […]” is grammatically incorrect. For examination purposes, the claim has interpreted to recite “the generally rectangular profile of has a height […] .” Appropriate correction is required.
Claim 10 is objected to because of the following informalities: there is no antecedent basis for “the neck of the urine collection container.” For examination purposes, Claim 10 has been interpreted as being dependent from claim 7, introduces a neck portion of the urine collection container.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “micro” in claim 3 is a relative term which renders the claim indefinite. The term “micro pump” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what structural and size limitations are required for a pump to be considered a “micro pump.”
For examination purposes, any pump that is small enough to be portable for use with the claimed portable urine collection system will be interpreted as a “micro pump.”
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 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Otto (US 2007/0225668) in view of Norton (US 4,512,771)
With respect to Claim 1, Otto teaches a portable urine collection system 10 (Figures 1-32, especially 1-13), comprising:
a urine collection device 18 configured to be positioned at least proximate to a urethra of a user (Figures 9, 13, and 16-25);
a conduit 28 in fluid communication with the urine collection device 18 (paragraph [0055]; Figures 10 and 13),
a urine collection container 26 having an interior region (paragraphs [0053-0054]; Figures 10, 13, and 26-29)
a pump 44 secured or securable to the urine collection container 26 and configured to promote urine from the urine collection device 18 through the conduit into the urine collection container (paragraph [0019]; Figures 13-15);
an exhaust vent 142 on the urine collection container 26 configured to allow trapped air to escape (paragraph [0054], [0069]; Figure 26); and
a sensor secured or securable to the container and configured to detect a property relating at least to a volume of the urine in the urine collection container 26 (paragraphs [0021], [0052], [0054], and [0076]; see “bag level sensor” in Figure 32).
Otto teaches the portable urine collection system as claimed, and further teaches that the vent 142 may include a filter 144 for preventing particles of a certain size or the like from escaping the reservoir [0069]. Otto, however, does not specifically teach that the exhaust vent comprises a hydrophobic filter configured to allow air to escape through the exhaust vent while inhibiting urine from exiting through the exhaust vent.
Norton teaches a venting assembly for use with a urine collection container (Column 1, Lines 14-24), the venting assembly 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, Line 53 through Column 2, Line 5). 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 the Otto’s exhaust vent 142 to include a hydrophobic filter thereon, as suggested by Norton, in order to provide an art-established means for allowing air to be vented from the container while preventing the escape of urine.
With respect to Claim 2, Otto further teaches a battery 42 operable coupled to the pump (see Abstract and paragraphs [0057]. [0075] and [0077]; Figures 13 and 32)
With respect to Claim 3, Otto teaches that the pump may include a peristaltic pump [0022]. Furthermore, the pump is sufficiently small to fit within the housing (Figures 1-13), and therefore has been interpreted as a micro pump.
With respect to Claims 4 and 6 Otto teaches that the pump 44 is connected to the conduit and the urine collection container to pump urine through the conduit into the container (Figure 13; paragraphs [0019-0020], [0052-0058], and [0063-0067). The pump 44 is securable to the urine collection container 26 between the conduit 28 and the urine collection container 26 via an inner enclosure 24 that connects to both the pump and the urine collection container (Figures 10-13; paragraphs [0019] and [0055-0057]). The pump 44 is configured to pull at least a partial vacuum on the urine collection container to pull at least a partial vacuum on the conduit and pull urine from the urine collection device 18 through the conduit and into the interior region of the urine collection container. See Figures 1-13 and 23-25; paragraphs [0019-0020], [0052-0058], and [0063-0067].
With respect to Claim 7, Otto teaches that the urine collection container 26 is generally rectangular and includes an upper surface and a neck protruding from the upper surface (see annotated Figure 26 below).
While Otto 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 26 as opposed to adjacent the upper surface of the collection container 26 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 Otto’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.
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Annotated Figure 26 of Otto
With respect to Claim 8, Otto teaches that the urine collection container 26, the battery 42, and the pump 44 together form a generally rectangular profile. Specifically, as seen in Figures 1-13, the collection container, battery, and pump are disposed in a generally rectangular profile to be enclosed within a generally rectangular housing 12.
With respect to Claim 9, Otto 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, Otto discloses that the system is designed to be portable and mountable on a mechanical wheelchair [0021], just like the instant invention. 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 Otto’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.
Wirth respect to Claim 10, Otto teaches that the exhaust vent 142 is disposed on the neck portion near the top of the urine collection container 26 (see Figure 26).
With respect to Claim 11, Otto teaches that the sensor may be a level sensor that determines when the collection container 26 is full (paragraphs [0021], [0052], [0054], and [0076]; see “bag level sensor” in Figure 32), but is silent regarding the exact location of the sensor on the collection container. Otto, therefore, does not explicitly teach that the sensor is positioned or positionable between or proximate to an intersection of the upper surface and neck of the collection container.
However, 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, Otto teaches that the level sensor is configured to sense when the urine collection container is full (paragraphs [0021], [0052], [0054], and [0076]; see “bag level sensor” in Figure 32), 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 Otto’s portable urine collection system such that the sensor is 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 Claims 13 and 14, Otto teaches 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].
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.
With respect to Claim 15, Otto teaches that the container and pump are sized and dimensioned such that they are capable of being mounted on a mechanical wheelchair. While Otto 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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Otto and Norton as applied to claim 1 above, and further in view of Ludin (US 2018/0280236).
With respect to Claim 12, Otto further teaches that the sensor communicates with a controller 30 that is configured to communicate with the sensor and pump [0056-0057], but 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 modify Otto’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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hughett et al. (US 2018/0214297) teaches a urine output collection and monitoring system comprising a vent with a hydrophobic filter [0164].
Bibara et al. (US 2012/0066825) teaches a portable urine collection device in a rectangular housing.
Hofstetter (US 4,356,012) teaches a urine collection bag comprising a vent with a hydrophobic filter.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas Weiss can be reached at (571) 270-1775. 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