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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/26/2026 has been entered.
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: The term "triangular" is not disclosed in the specification, rather it is defined as a notch, where the notch can be different (interpreted as different shapes). As such, the term “triangular” as newly amended into claims 1, 17 lacks antecedent basis in the specification.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-13,15-18,20,22-27 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. Claim 28 is added. The examiner notes that upon the amendments to the claims, the prior art rejection is updated.
Per applicant’s arguments (directed to claim 25) that Otto fails to teach that the pump is activated and deactivated by the user where the user input comprises one or more of a button and switch, configured for glove-operable actuation, the examiner notes that Otto teaches this limitation. The rejection of claim 25 has been updated.
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.
Claim(s) 1-2,8-10, 15-16, 22,27 is/are rejected under 35 U.S.C. 103 as being unpatentable over previously applied references Davis, Johannes Street, Austermann, and Lawrence and further in view of Steer US 4568339, hereafter Steer.
Regarding Claim 1, Davis discloses
A bladder relief system (Abstract) comprising: a collection interface sized and configured for seated or standing application (Figs. 1-7, 10; collection interface (10)), the collection interface further comprising: a sleeve (external covering (20)), defining a collection opening (fenestration (30)), and sidewalls defining a collection cavity (Para. 0052), an interface tubing, extending from one end of the sleeve to another, between a collection end of the interface tubing (Figs. 2-7;Tube (32), Para. 0060), and an exit port (Open first end of sleeve (22)). The examiner notes that per paragraph 0060, a first end (33) of the tube (32) is configured to extend out from the first open end of the sleeve (22), and direct fluid from a second end of the sleeve (24) through second end of tube (34) and toward first end of tube (33). It is therefore interpreted that the open first end of the sleeve is an exit port.
Davis further discloses an adsorbing material contained within the collection cavity (Fig. 7, collection layers (40,42), paragraph 0057). The examiner notes that per paragraph 0057, the collection layers are made of a highly absorptive material to absorb and wick fluid into the cavity, and therefore read to the claimed limitation.
However, in this embodiment, Davis does not specifically disclose an exit hose. In a separate embodiment of Davis, Davis teaches the use of an external tubing extending out of collection device (Fig. 27A-B, tube (32), collection device (10)), where said tubing comprises an adapter (70, with embodiments detailed in para. 0102) for connecting to a second length of tubing, where second length of tubing may be a suction tubing (Para. 0102). As per the first embodiment the tubing (34) seen in figures 2-7 extends outside of the collection device per paragraph 0060, and the function of said device with tubing is divert fluid to a reservoir away from the body (Para. 0061). Further, as seen in figure 32, the collection device (10) is seen connected to a reservoir (204) and a vacuum source (210). 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 provide the tubing seen in figures 2-7, with the adapter seen in figures 27A-B in
order to connect the tubing to a second tubing that provides suction and diversion into a reservoir away from the body. The examiner notes that seen in these figures that exit tubing, as well as the internal tubing may be surrounded by a corrugated layer as a means to limit discomfort to the user (Fig. 11B,27A)(Para. 0057).
However Davis fails to specifically disclose wherein the collection interface is about 0.5 inch to about 1 inch in diameter and about 2 inches to about 7 inches in length
Johannes teaches a urine collection device and is thus considered analogous to the claimed invention. As seen in the figures of Johannes, a device comprising an external covering, absorbent material, and tubing system is taught, similar to that of Davis. Johannes teaches that the size of the device may vary based on the needs of the user (para. 0062), where various embodiments of the size of the device are then taught, including a length of 7.5 inches and a diameter of .5 inch (para. 0062-0063). The examiner notes that the diameter taught by Johannes is within the claimed range, and the length is overlapping with the range, as detailed hereafter. The examiner notes that per MPEP 2144.05 (I), In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped. Therefore as the claimed limitation is about 2 inches to about 7 inches in length, a taught length of 7.5 inches would overlap with the about 7 inches limitation per In re Woodruff. The examiner further notes that per MPEP 2144.05 (I), a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. 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 modify the device of Davis to be within the taught dimension of Johannes such that the device accommodates for various different types or sizes of users.
Davis further discloses a pump (Fig. 32, vacuum source or pump (210), para. 0107), for facilitating flow of fluid from the collection cavity through the interface tubing (Para. 0060), exit hose, and into the collection receptacle (reservoir (204))(Fig. 32). However, the pump of Davis is disclosed to be a vacuum pump. Further although per paragraph 0108 Davis discloses that the pump of the device is a pump that is commercially available, and not limited to a wall based pump, it is not specifically stated that the pump and therefore the device is portable.
Street teaches a waste disposal garment and is thus considered analogous to the claimed invention. Although Street is directed to a vacuum based system (abstract) to direct the flow of discharge to a waste container, Street teaches that alternatively a positive displacement such as a peristaltic pump may be used instead of said vacuum system (Column 4 lines 10-16). Per this teaching it is interpreted that vacuum pumps and peristaltic pumps are interchangeable in the art for directing urine from a user to a collection area, and as such, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use a peristaltic pump as the pump of Davis.
Further, Street discloses that the system may be portable so long as the individual components of the system can be mobile, and therefore usable while sitting or standing, making the system more convenient for the removal of urine (Column 2 lines 35-40). 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 have the individual components of the combination of Davis and Street be portable such that the device can be used while standing or sitting making the device more convenient. The examiner further notes that Davis discloses the use of an anchor (50) to aid in the securing of the device despite a wearer’s motion (para. 0086). Therefore it is interpreted that the device may be used in a situation where a user has some mobility, not only for a bedbound user only laying down. Therefore it is interpreted that Davis in view of Street and Johannes teaches that the device is configured to accommodate a seated or standing application.
Should the applicant not accept this interpretation, the examiner notes that per the MPEP
section 2114 section II “"[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)
(emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed
apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art
apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as
Davis in combination with Johannes and Street teaches a urine collection device with a structure that is found to be equivalent to the claimed invention, and that use of the device for seated or standing user is functional language, the prior art combination would read to said functional language.
Davis however, fails to disclose a cross sectional tear drop shape perpendicular to the longitudinal axis.
Austermann teaches a urine collection device and is thus considered analogous to the claimed invention. Austermann teaches that the device is generally cylindrical (para. 0093), as seen in the embodiment of figure 4B. The examiner notes that as seen in 4B the cross section of the cylindrical body is seen to be tear shaped. The examiner notes that this shape seen in figure 4b is interpreted as tear shaped as the body is seen to be wide and rounded at one end and tapers to a narrower point at the opposite end. Per the abstract, Austermann teaches that the device is shaped such as to conform to the anatomy of the user. 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 provide the cylindrical body of Davis with a tear shaped cross section, as Austermann teaches that cylindrical urine collection devices may have tear drop cross sections due the said shape allowing for the device to compliment the user’s anatomy.
Should applicant disagree with this rejection of Davis in view of Austermann, the examiner notes that per MPEP Section 2144.04 IV B, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container 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 of the claimed container was significant.). Therefore as Davis discloses a cylindrical shaped device, Austermann teaches that cylindrically shaped devices may have teardrop shaped cross-sections, and there is a lack of criticality to the collection interface shape as per paragraph 0036 of the instant specification “The collection interface100 may be other shapes including but not limited to hourglass, teardrop, tubular, frusto-conical, etc.”, there is no persuasive evidence that the particular configuration of the claimed container was significant. As such it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cylinder shape of Davis to have a teardrop shaped cross section.
Per the amendments filed 06/26/2025, the examiner notes that the rejection has been updated. Claim 1 requires that the collection receptacle is a bag. Per Johannes (para. 0092), the fluid storage container may be any suitable container for storing fluids, where suitable containers includes a bag. Therefore as Johannes teaches that bags are suitable collection receptacles for urine, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a bag as the collection receptacle of the prior art invention.
Claim 1 further requires that the pump is disclosed between the collection interface and collection receptacle. The examiner notes that per the rejection, it was found obvious to use a peristaltic pump as the pump of the system. The examiner notes that while it is known that a peristaltic pump operates by pushing fluid through using a rotor or other means, and therefore would reasonably be placed between the interface and container in order to function properly, there is no clear indication in the combination of arts that the pump is located in said location. Therefore for clarity, the examiner relies on Lawrence. Lawrence teaches a liquid collection system and is thus considered analogous to the claimed invention. Lawrence teaches that a pump for the system (figure 10, (112)) where said pump is a peristaltic pump (column 10, lines 58-67) located between the interface (piece connected to 110) and the container (113). Therefore as peristaltic pumps are configured to push fluid through the system, and Lawrence teaches that in using a peristaltic pump in a fluid collection system, the pump would be between the collection interface and the container, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to place the peristaltic pump of the prior arts between the interface and container as a means to ensure proper functionality of a peristaltic pump.
The examiner notes that the amended limitation (01/26/2026) of the tubing configured in a triangular shape is hereafter addressed. Per paragraph 0078 of Davis the end of the tubing may have a slit, aperture, or cut out portion, as seen in figure 19. The examiner notes that although said shape is not seen to be a triangle, MPEP Section 2144.04 IV B states n re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container 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 of the claimed container was significant. Therefore, as Davis teaches a cutout in a tube, where the only difference between the prior art and instant application is the shape of the cutout, and the examiner notes that the instant application states (para. 0049) that “different notch patterns may be used”, thus showing a lack of criticality for the shape, it is interpreted that the shape of the cutout, absent persuasive evidence, is not significant. 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 make the cutout of Davis a triangle shape as an obvious matter of change of shape.
Further, the claim was amended to include the limitation of the interface tubing “in a triangular shape to prevent leaks and occlusion”. The examiner notes that as detailed above, it was found obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to configure the tubing to have a triangular shape. Davis teaches that the device, which includes the slit, aperture, or cutout, is configured to prevent fluid leakage from the device as a whole (para. 0051), where the configuration of the tubing further aids in prevent leakage (para. 0056,0079). As such it is interpreted that the tubing, with the triangle shape would therefore also prevent leakage. Should applicant disagree, the examiner notes the examiner notes that per the MPEP section 2114 section II “"[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) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as prior teaches a urine collection device with a tubing comprising a triangle shape at one end, where said structure is found to be equivalent to the claimed invention, and that the prevention of leakage and occlusion is functional language, the prior art combination would read to said functional language.
Further, the claim was amended to include the limitation of a tactile indicator configured and oriented to be felt by a user and thereby indicate the location of the collection interface without visual inspection. The examiner notes that due to the breadth of the limitation, various components, such as the hard cap (28), the external texturing (para. 0053), or end of the collection device where the tubing exits (see figure 6) may be interpreted as a tactile indicator as the provide a clear difference in structure that would be felt by a user, where said components are indicative of a specific position of the device.
The examiner notes that in an attempt to establish compact prosecution, reference Steer is brought in to teach a tactile indicator, including bumps on an exit hose, per the instant specification and amended dependent claim 22.
Steer teaches a fluid collection device and is thus considered analogous to the claimed invention. Steer teaches that the device comprises an outlet pipe (figure 5,7,8 (pipe 12)) where said pipe comprises a series of ridges (44) which allows for fit with a drainage tube. The examiner notes that as a means to aid in attaching a drainage tube to the collection interface, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a series of ridges on the outlet of the device. The examiner notes that said ridges are interpreted as a tactile indicator including a bump on the exit hose (where the ridges are a bump themselves and would further form a bump in the tube when connected) and as such read to the claimed limitation.
Regarding Claim 2, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, wherein the collection interface, and its subcomponents, the exit hose, and collection receptacle are disposable. Per paragraph 0107 of Davis, the external collection reservoir is disposable. Further, per paragraph 0112 of Davis, the device is removed from the patient and may need to be replaced periodically, where said device should be disposed of according to hospital protocol. It is therefore interpreted that the device (collection interface) along with its subcomponents, as well as the tubing and receptacle are all disposable.
Regarding Claim 8, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, wherein the collection interface is incorporated into an undergarment. Per paragraph 0093 of Davis, the device is configured to be used in association with a wearable garment such as a brief as a means to hold the collection device.
Regarding Claim 9, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, wherein the collection interface is flexible. Per paragraph 0062 of Davis, the urine collection device (10) which comprises the collection interface as defined under the rejection of claim 1 is disclosed to comprise a shape retaining element configured to bend and conform the fluid collection assembly to a curved configuration. Therefore as the collection device is bendable into a curved configuration it is interpreted a flexible. The examiner notes further that per paragraph 0063, the tubing (part of the collection interface per claim 1) is disclosed to be flexible.
Regarding Claim 10, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, wherein the entire bladder relief system is disposable. Per paragraph 0107 of Davis, the external collection reservoir is disposable. Further, per paragraph 0112 of Davis, the device is removed from the patient and may need to be replaced periodically, where said device should be disposed of according to hospital protocol. It is therefore interpreted that the device (collection interface) along with its subcomponents, as well as the tubing and receptacle are all disposable.
Regarding claim 15, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, wherein the exit hose comprises a composite structure to limit minimum bend radius. The examiner notes that as detailed under the rejection of claim 1, the tubings of Davis may comprise a corrugated layer to provide a cushion around the tubings (para. 0057), where the tubings (32, 36) are seen corrugated per figures (11B for tubing (32)) and 27A for tubing (36)). As said corrugated layer is formed around the tubing, it is interpreted that the tubing structure is corrugated as the tube and the corrugated layer form the new tubing. Said corrugation is interpreted as a composite structure.
Regarding claim 16, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 15, wherein the exit hose is selected from a soft tube material, inflatable tubing, flat tubing, corrugated tubing, spiral wire tubing, variable diameter tubing, or coiled tubing. As detailed under the rejection of claim 15, Davis teaches a corrugated tubing.
Regarding claim 22, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, wherein the tactile indicator comprises at least a raised bump on the exit hose. The examiner notes that per the rejection of claim 1 in view of Street, the tactile indicator comprises at least a raised bump on the exit hose.
Regarding claim 27, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 17, wherein the collection interface is adapted with a texture on an external surface of the collection interface configured to further maintain the position of the collection interface. Davis para. 0053 teaches that the external covering of the urine collection interface may have a texture that grips the skin, allowing for greater stability.
Claim(s) 3,11,13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Johannes, Street, Austermann, Lawrence, and Steer, and further in view of Hirsch et al. US 5496300 , hereafter Hirsch.
Regarding Claim 3, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, wherein the collection device readily disconnectable from the remainder of the system without leakage. The examiner notes that as detailed under the rejection of claim 1, the tubing (32) is connected to the exit hose via an adapter, where the exemplary embodiments are detailed under paragraph 0102 of Davis. Further the examiner notes that as the adapter is used to connect the two tubes and thus connect the collection device to a reservoir and suction source, the device would also be readily disconnectable from the same system. As per paragraph 0102 the adapter may include step tapering to allow for the adapter to fit snugly, which is interpreted to help prevent leakage, as a snug fit would not allow fluid to leak out. However, Davis does not specifically disclose that said connection is a quick disconnect system.
Hirsch teaches a coupling device for connection to a urine collection device and is thus considered analogous to the claimed invention. Hirsch teaches the use of a quick disconnect means (Fig. 1, coupling device (22) with first and second coupling member (24 and 25)) to provide a continuous
fluid pathway between a catheter and a collection bag when connected, as well as the ability for quick and easy disconnection when draining, cleaning or replacement of the bag is needed (Column 3, lines 42-59). Per column 2, lines 59-65 while connected the device is fluidly sealed to prevent spillage. Further Hirsch teaches that upon disconnection closure members (42 and 43), seen in figure 5 to be a component of coupling members (24 and 25), are biased by springs (44 and 46) as to seal off the tube and (17) and line (11), preventing urine from dripping out of the tube upon disconnection (Column 5 lines 3-8). 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 use a quick disconnect system as taught by Hirsch as the adapter of Davis, as said quick disconnects are known in the art to connect components of urine collection systems, and doing so would allow for an easy attachment and replacement of parts of the system of Davis, as well as providing a fluid sealed connection upon both connection and disconnection.
Regarding Claim 11, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, wherein the exit port is connected to the exit tubing via a self-sealing quick disconnect system, to allow a user to quickly disconnect from the system for enhanced mobility. The examiner notes that as detailed under the rejection of claim 1, the tubing (32) is connected to the exit hose via an adapter, where the exemplary embodiments are detailed under paragraph 0102 of Davis. Further the examiner notes that as the adapter is used to connect the two tubes and thus connect the collection device to a reservoir and suction source, the device would also be readily disconnectable from the same system. As per paragraph 0102 the adapter may include step tapering to allow for the adapter to fit snugly, which is interpreted to help prevent leakage, as a snug fit would not allow fluid to leak out. However, Davis does not specifically disclose that said connection is a quick disconnect system.
Hirsch teaches a coupling device for connection to a urine collection device and is thus considered analogous to the claimed invention. Hirsch teaches the use of a quick disconnect means (Fig. 1, coupling device (22) with first and second coupling member (24 and 25)) to provide a continuous fluid pathway between a catheter and a collection bag when connected, as well as the ability for quick and easy disconnection when draining, cleaning or replacement of the bag is needed (Column 3, lines 42-59). Per column 2, lines 59-65 while connected the device is fluidly sealed to prevent spillage. Further Hirsch teaches that upon disconnection closure members (42 and 43), seen in figure 5 to be a component of coupling members (24 and 25), are biased by springs (44 and 46) as to seal off the tube and (17) and line (11), preventing urine from dripping out of the tube upon disconnection (Column 5 lines 3-8). 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 use a quick disconnect system as taught by Hirsch as the adapter of Davis, as said quick disconnects are known in the art to connect components of urine collection systems, and doing so would allow for an easy attachment and replacement of parts of the system of Davis, as well as providing a fluid sealed connection upon both connection and disconnection. The examiner notes that upon combination the quick disconnect system would connect the exit port to the exit tubing as the connector is used to connect a urine receptacle toa collection bag. Further as the connector seals via springs upon disconnection, it is interpreted as self-sealing.
Regarding Claim 13, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 11, wherein the exit tubing is connected to the collection receptacle via the self-sealing quick system disconnect to facilitate removal and or replacement of the collection receptacle. The examiner notes that as detailed under the rejection of claim 11, Hirsch teaches the use of a quick disconnect means (Fig. 1, coupling device (22) with first and second coupling member (24 and 25)) to provide a continuous fluid pathway between a catheter and a collection bag when connected, as well as the ability for quick and easy disconnection when draining, cleaning or replacement of the bag is needed (Column 3, lines 42-59). Per column 2, lines 59-65 while connected the device is fluidly sealed to prevent spillage. Further Hirsch teaches that upon disconnection closure members (42 and 43), seen in figure 5 to be a component of coupling members (24 and 25), are biased by springs (44 and 46) as to seal off the tube and (17) and line (11), preventing urine from dripping out of the tube upon disconnection (Column 5 lines 3-8). The examiner notes that as the connector is used to connect a urine receptacle toa collection bag the quick disconnect system upon combination with Davis and street would connect the exit tubing to the collection receptacle. Further as the connector seals via springs upon disconnection, it is interpreted as self-sealing.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Johannes, Street, Austermann, Lawrence, and Steer, and further in view of Newton US 2013/0338617, hereafter Newton.
Regarding claim 4, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1. While the combination, as detailed under the rejection of claim 1 teach a collection bag, said receptacle is not taught to be provided with one or more one way air vents to vent to the outside of the collection receptacle, having a valve configured to allow air to escape from the receptacle while preventing liquid leakage and inflation during pumping operation.
Newton teaches an external urine collection system and is thus considered analogous to the claimed invention. Newton teaches that an external collector for urine may include an air vent (fig. 1, (112)), where said air vent may be a gas permeable, liquid impermeable valve (para. 0031). Further, per para. 0031, the vent prevents the container from becoming inflated from air and only allows air to escape. This allowing of air to escape also helps to prevent leaks (para. 0031). Therefore as a means to prevent leaks and prevent collection bag inflation, it would have been obvious to one having ordinary skill in the art to provide the bag of the prior art with a vent with a valve to only let air out and prevent liquid from leaving the bag.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Johannes, Street, Austermann, Lawrence, and Steer and further in view of Glithero et al. US 2020/0390591, hereafter Glithero.
Regarding claim 5, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, wherein the pump is activated continuously but fails to teach that the pump has increased pressure upon sensing moisture
Glithero teaches a fluid collection garment and is thus considered analogous to the claimed invention. Glithero teaches the use of a pump where said pump can be a peristaltic pump (para. 0088) to aid in the removal of fluid from a device into a container (para. 0087). Glithero further teaches that the device may comprise a moisture sensor for detecting moisture in a chamber such that the pump is controlled to operate based on the sensed moisture automatically (para. 0097). It is interpreted that the pump is moisture activated as the pump is configured to modify its operation in response to sensed data. Therefore, as Glithero teaches that peristaltic pumps for removing moisture from a collection device may be used with sensors to facilitate automatic activation of said pumps to remove moisture, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the sensor configuration of Glithero with the peristaltic pump of Davis and Street, in order to make fluid removal through activation of the pump automatic when needed.
Regarding claim 6, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, but fails to disclose that the pump is moisture activated.
Glithero teaches a fluid collection garment and is thus considered analogous to the claimed invention. Glithero teaches the use of a pump where said pump can be a peristaltic pump (para. 0088) to aid in the removal of fluid from a device into a container (para. 0087). Glithero further teaches that the device may comprise a moisture sensor for detecting moisture in a chamber such that the pump is controlled to operate based on the sensed moisture automatically (para. 0097). It is interpreted that the pump is moisture activated as the pump is configured to modify its operation in response to sensed data. Therefore, as Glithero teaches that peristaltic pumps for removing moisture from a collection device may be used with sensors to facilitate automatic activation of said pumps to remove moisture, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the sensor configuration of Glithero with the peristaltic pump of Davis and Street, in order to make fluid removal through activation of the pump automatic when needed.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Johannes, Street, Austermann, Lawrence, Steer, and Hirsch and further in view of Martin US 2022/0249273, hereafter Martin.
Regarding Claim 7, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, wherein the pump is a gear pump. As detailed under the rejection of claim 1, Street discloses the use of a peristaltic pump (Column 4 lines 10-16). However, no gear pump is disclosed.
Martin teaches a urine collection device and is thus considered analogous to the claimed invention. Martin teaches that the pump of the system may be a rotary lobe, gear pump, diaphragm pump, or any other pump capable of providing the same function (para. 0039). The examiner notes that Martin is directed to using positive displacement pumps (rotary lobe, gear, diaphragm), of which, a peristaltic pump is. Therefore as Martin teaches that suitable pumps for urine collection include rotary lobe, gear, diaphragm, or any other suitable, where a peristaltic pump is interpreted to be suitable due to it also being a positive displacement pump, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a gear pump instead of a peristaltic pump as a matter of simple substitution, since both are suitable positive displacement pumps.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Johannes, Street, Austermann, Lawrence, Steer, and Hirsch and further in view of Glithero.
Regarding claim 12, Davis, Johannes, Street, Austermann, Lawrence, Steer, and Hirsch teach
The bladder relief system of claim 11, but fail to teach wherein the pump is a moisture activated non-vacuum peristaltic pump.
Glithero teaches a fluid collection garment and is thus considered analogous to the claimed invention. Glithero teaches the use of a pump where said pump can be a peristaltic pump (para. 0088) to aid in the removal of fluid from a device into a container (para. 0087). Glithero further teaches that the device may comprise a moisture sensor for detecting moisture in a chamber such that the pump is controlled to operate based on the sensed moisture automatically (para. 0097). It is interpreted that the
pump is moisture activated as the pump is configured to modify its operation in response to sensed data. Therefore, as Glithero teaches that peristaltic pumps for removing moisture from a collection device may be used with sensors to facilitate automatic activation of said pumps to remove moisture, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the sensor configuration of Glithero with the non-vacuum peristaltic pump taught by the combination of Davis and Street, in order to make fluid removal through activation of the pump automatic when needed.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Johannes, Street, Austermann, Lawrence, and Steer, and further in view of Gable et al. US 2006/0189925, hereafter Gable.
Regarding claim 28, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach the bladder relief system of claim 1. The examiner notes that per the rejection of claim 1, the prior art teach a peristaltic pump for use within the system. However it is not specifically taught wherein the pump is configured to operate in reverse to allow for an influx of air to facilitate drying.
Gable teaches a fluid collection device, where said fluid may be urine (para. 0434) and is thus considered analogous to the claimed invention. Gable teaches that suitable pumps for collection may include a reversible peristaltic pump, unidirectional pump, displacement pump, and more (para. 0085). Therefore as Gable teaches that a reversible peristaltic pump is suitable for use in a fluid collection system, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a reversible peristaltic pump as the peristaltic pump included in the rejection of claim 1. Doing so would merely involve the simple substitution of one known element for another to obtain predictable results, that being operation of a fluid collection system, and thus a prima facie case of obviousness exists. The examiner notes that as peristaltic pumps are configured to flow through, where air is a fluid, it is interpreted that the peristaltic pump of the prior art device as detailed above, when operate in reverse would be capable of creating an influx (flowing) of air through thus facilitating drying.
Claim(s) 17,23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Johannes and Newton and Hirsch and Street and Austermann, Lawrence, and further in view of Glithero and Steer.
Regarding claim 17, Davis, discloses
A portable bladder relief system (Abstract, the examiner notes that as the device is capable of being moved, it is interpreted as portable, see also below for further rejection) comprising: a flexible collection interface ((Figs. 1-7, 10; collection interface (10)), para. 0059 where the collection components are disclosed to be flexible) wherein the collection interface is configured to accommodate seated or standing application, and is adapted with reinforcement to conform to the anatomy without shifting or twisting during movement and/or use (para. 0086 where anchor (50) holds the device in place during movement), and is shaped to be worn and maintain position during activity (para. 0086, anchor (50), figure 10), the collection interface further comprising: a sleeve (external covering (20)), defining a collection opening (fenestration (30)), and sidewalls defining a collection cavity (para. 0052), an interface tubing, extending from one end of the sleeve to another, between a collection end of the interface tubing (Figs. 2-7; tube (32), para. 0060)), and an exit port (open end of sleeve (22)). The examiner notes that per paragraph 0060, a first end (33) of the tube (32) is configured to extend out from the first open end of the sleeve (22), and direct fluid from a second end of the sleeve (24) through second end of tube (34) and toward first end of tube (33). It is therefore interpreted that the open first end of the sleeve is an exit port.
However, Davis fails to specifically disclose wherein the collection interface is about 0.5 inch to about 1 inch in diameter and about 2 inches to about 7 inches in length
Johannes teaches a urine collection device and is thus considered analogous to the claimed invention. As seen in the figures of Johannes, a device comprising an external covering, absorbent material, and tubing system is taught, similar to that of Davis. Johannes teaches that the size of the device may vary based on the needs of the user (para. 0062), where various embodiments of the size of the device are then taught, including a length of 7.5 inches and a diameter of .5 inch (para. 0062-0063). The examiner notes that the diameter taught by Johannes is within the claimed range, and the length is overlapping with the range, as detailed hereafter. The examiner notes that per MPEP 2144.05 (I), In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped. Therefore as the claimed limitation is about 2 inches to about 7 inches in length, a taught length of 7.5 inches would overlap with the about 7 inches limitation per In re Woodruff. The examiner further notes that per MPEP 2144.05 (I), a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. 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 modify the device of Davis to be within the taught dimension of Johannes such that the device accommodates for various different types or sizes of users.
Davis further discloses an adsorbing material contained within the collection cavity (Fig. 7, collection layers (40,42), para. 0057) The examiner notes that per paragraph 0057, the collection layers are made of a highly absorptive material to absorb and wick fluid into the cavity, and therefore read to the claimed limitation.
Davis further discloses a texturized surface on the interface to increase friction with undergarment and reduce motion and or provide tactile indication of placement. The examiner notes that as detailed under the same rejection of claim 17, Davis teaches the use of an anchor (50), where per paragraph 0086, said anchor is configured to secure the device 10 in position to collect and transport urine voided by a user, and may be attached using adhesive (para 0088) or an elastic band or strap (para. 0093). Said anchor configurations are configured to hold the device in a useable position, and are textured through adhesive or additional components such as an elastic band, it is interpreted that said anchor reads to the claimed limitation.
However, in this embodiment, Davis does not specifically disclose an exit hose. In a separate embodiment of Davis, Davis teaches the use of an external tubing extending out of collection device (Fig. 27A-B, tube (32), collection device (10)), where said tubing comprises an adapter (70, with embodiments detailed in para. 0102) for connecting to a second length of tubing, where second length of tubing may be a suction tubing (Para. 0102). As per the first embodiment the tubing (34) seen in figures 2-7 extends outside of the collection device per paragraph 0060, and the function of said device with tubing is divert fluid to a reservoir away from the body (Para. 0061). Further, as seen in figure 32, the collection device (10) is seen connected to a reservoir (204) and a vacuum source (210). Said reservoir is interpreted as a collection receptacle. However, said receptacle is not taught to be provided with one or more one way air vents to vent to the outside of the collection receptacle.
Newton teaches an external urine collection system and is thus considered analogous to the claimed invention. Newton teaches that an external collector for urine may include an air vent (fig. 1, (112)), where said air vent may be a gas permeable, liquid impermeable valve (para. 0031). Further, per para. 0031, the vent prevents the container from becoming inflated from air and only allows air to escape. This allowing of air to escape also helps to prevent leaks (para. 0031). Therefore as a means to prevent leaks and prevent collection bag inflation, it would have been obvious to one having ordinary skill in the art to provide the bag of the prior art with a vent with a valve to only let air out and prevent liquid from leaving the bag.
Further, Davis does not specifically disclose that said exit tubing connection is a quick disconnect system.
Hirsch teaches a coupling device for connection to a urine collection device and is thus considered analogous to the claimed invention. Hirsch teaches the use of a quick disconnect means (Fig. 1, coupling device (22) with first and second coupling member (24 and 25)) to provide a continuous fluid pathway between a catheter and a collection bag when connected, as well as the ability for quick and easy disconnection when draining, cleaning or replacement of the bag is needed (Column 3, lines 42-59). Per column 2, lines 59-65 while connected the device is fluidly sealed to prevent spillage. Further Hirsch teaches that upon disconnection closure members (42 and 43), seen in figure 5 to be a component of coupling members (24 and 25), are biased by springs (44 and 46) as to seal off the tube and (17) and line (11), preventing urine from dripping out of the tube upon disconnection (Column 5 lines 3-8). 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 use a quick disconnect system as taught by Hirsch as the adapter of Davis, as said quick disconnects are known in the art to connect components of urine collection systems, and doing so would allow for an easy attachment and replacement of parts of the system of Davis, as well as providing a fluid sealed connection upon both connection and disconnection. The examiner notes that upon combination the quick disconnect system would connect the exit port to the exit tubing as the connector is used to connect a urine receptacle toa collection bag. Further as the connector seals via springs upon disconnection, it is interpreted as self-sealing.
Davis further discloses a pump (Fig. 32, vacuum source or pump (210), para. 0107), for facilitating flow of fluid from the collection cavity through the interface tubing (Para. 0060), exit hose, and into the collection receptacle (reservoir (204))(Fig. 32). However, the pump of Davis is disclosed to be a vacuum pump. Further although per paragraph 0108 Davis discloses that the pump of the device is a pump that is commercially available, and not limited to a wall based pump, it is not specifically stated that the pump and therefore the device is portable.
Street teaches a waste disposal garment and is thus considered analogous to the claimed invention. Although Street is directed to a vacuum based system (abstract) to direct the flow of discharge to a waste container, Street teaches that alternatively a positive displacement such as a peristaltic pump may be used instead of said vacuum system (Column 4 lines 10-16). Per this teaching it is interpreted that vacuum pumps and peristaltic pumps are interchangeable in the art for directing urine from a user to a collection area, and as such, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use a peristaltic pump as the pump of Davis.
Further, Street discloses that the system may be portable so long as the individual components of the system can be mobile, and therefore usable while sitting or standing, making the system more convenient for the removal of urine (Column 2 lines 35-40). 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 have the individual components of the combination of Davis and Street be portable such that the device can be used while standing or sitting making the device more convenient. The examiner further notes that as detailed above, Davis discloses the use of an anchor (50) to aid in the securing of the device despite a wearer’s motion (para. 0086). Therefore it is interpreted that the device may be used in a situation where a user has some mobility, not only for a bedbound user only laying down. Therefore it is interpreted that Davis in view of Street and Johannes teaches that the device is configured to accommodate a seated or standing application.
Should the applicant not accept this interpretation, the examiner notes that per the MPEP
section 2114 section II “"[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)
(emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed
apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art
apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as
Davis in combination with Johannes and Street teaches a urine collection device with a structure that is found to be equivalent to the claimed invention, and that use of the device for seated or standing user is functional language, the prior art combination would read to said functional language.
However, the combination of arts fail to teach that said pump is moisture activated.
Glithero teaches a fluid collection garment and is thus considered analogous to the claimed invention. Glithero teaches the use of a pump where said pump can be a peristaltic pump (para. 0088) to aid in the removal of fluid from a device into a container (para. 0087). Glithero further teaches that the device may comprise a moisture sensor for detecting moisture in a chamber such that the pump is controlled to operate based on the sensed moisture automatically (para. 0097). It is interpreted that the pump is moisture activated as the pump is configured to modify its operation in response to sensed data. Therefore, as Glithero teaches that peristaltic pumps for removing moisture from a collection device may be used with sensors to facilitate automatic activation of said pumps to remove moisture, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the sensor configuration of Glithero with the peristaltic pump of Davis and Street, in order to make fluid removal through activation of the pump automatic when needed.
Davis however, fails to disclose a cross sectional tear drop shape perpendicular to the longitudinal axis.
Austermann teaches a urine collection device and is thus considered analogous to the claimed invention. Austermann teaches that the device is generally cylindrical (para. 0093), as seen in the embodiment of figure 4B. The examiner notes that as seen in 4B the cross section of the cylindrical body is seen to be tear shaped. The examiner notes that this shape seen in figure 4b is interpreted as tear shaped as the body is seen to be wide and rounded at one end and tapers to a narrower point at the opposite end. Per the abstract, Austermann teaches that the device is shaped such as to conform to the anatomy of the user. 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 provide the cylindrical body of Davis with a tear shaped cross section, as Austermann teaches that cylindrical urine collection devices may have tear drop cross sections due the said shape allowing for the device to compliment the user’s anatomy.
Should applicant disagree with this rejection of Davis in view of Austermann, the examiner notes that per MPEP Section 2144.04 IV B, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container 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 of the claimed container was significant.). Therefore as Davis discloses a cylindrical shaped device, Austermann teaches that cylindrically shaped devices may have teardrop shaped cross-sections, and there is a lack of criticality to the collection interface shape as per paragraph 0036 of the instant specification “The collection interface100 may be other shapes including but not limited to hourglass, teardrop, tubular, frusto-conical, etc.”, there is no persuasive evidence that the particular configuration of the claimed container was significant. As such it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cylinder shape of Davis to have a teardrop shaped cross section.
Per the amendments filed 06/26/2025, the examiner notes that the rejection has been updated. Claim 1 requires that the collection receptacle is a bag. Per Johannes (para. 0092), the fluid storage container may be any suitable container for storing fluids, where suitable containers includes a bag. Therefore as Johannes teaches that bags are suitable collection receptacles for urine, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a bag as the collection receptacle of the prior art invention.
Claim 1 further requires that the pump is disclosed between the collection interface and collection receptacle. The examiner notes that per the rejection, it was found obvious to use a peristaltic pump as the pump of the system. The examiner notes that while it is known that a peristaltic pump operates by pushing fluid through using a rotor or other means, and therefore would reasonably be placed between the interface and container in order to function properly, there is no clear indication in the combination of arts that the pump is located in said location. Therefore for clarity, the examiner relies on Lawrence. Lawrence teaches a liquid collection system and is thus considered analogous to the claimed invention. Lawrence teaches that a pump for the system (figure 10, (112)) where said pump is a peristaltic pump (column 10, lines 58-67) located between the interface (piece connected to 110) and the container (113). Therefore as peristaltic pumps are configured to push fluid through the system, and Lawrence teaches that in using a peristaltic pump in a fluid collection system, the pump would be between the collection interface and the container, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to place the peristaltic pump of the prior arts between the interface and container as a means to ensure proper functionality of a peristaltic pump.
The examiner notes that the amended limitation (01/26/2026) of the tubing configured in a triangular shape is hereafter addressed. Per paragraph 0078 of Davis the end of the tubing may have a slit, aperture, or cut out portion, as seen in figure 19. The examiner notes that although said shape is not seen to be a triangle, MPEP Section 2144.04 IV B states n re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container 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 of the claimed container was significant. Therefore, as Davis teaches a cutout in a tube, where the only difference between the prior art and instant application is the shape of the cutout, and the examiner notes that the instant application states (para. 0049) that “different notch patterns may be used”, thus showing a lack of criticality for the shape, it is interpreted that the shape of the cutout, absent persuasive evidence, is not significant. 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 make the cutout of Davis a triangle shape as an obvious matter of change of shape.
Further, the claim was amended to include the limitation of the interface tubing “in a triangular shape to prevent leaks and occlusion”. The examiner notes that as detailed above, it was found obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to configure the tubing to have a triangular shape. Davis teaches that the device, which includes the slit, aperture, or cutout, is configured to prevent fluid leakage from the device as a whole (para. 0051), where the configuration of the tubing further aids in prevent leakage (para. 0056,0079). As such it is interpreted that the tubing, with the triangle shape would therefore also prevent leakage. Should applicant disagree, the examiner notes the examiner notes that per the MPEP section 2114 section II “"[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) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as prior teaches a urine collection device with a tubing comprising a triangle shape at one end, where said structure is found to be equivalent to the claimed invention, and that the prevention of leakage and occlusion is functional language, the prior art combination would read to said functional language.
Further, the claim was amended to include the limitation of a tactile indicator configured and oriented to be felt by a user and thereby indicate the location of the collection interface without visual inspection. The examiner notes that due to the breadth of the limitation, various components, such as the hard cap (28), the external texturing (para. 0053), or end of the collection device where the tubing exits (see figure 6) may be interpreted as a tactile indicator as the provide a clear difference in structure that would be felt by a user, where said components are indicative of a specific position of the device.
The examiner notes that in an attempt to establish compact prosecution, reference Miller is brought in to teach a tactile indicator, including bumps on an exit hose, per the instant specification and amended dependent claim 22.
Steer teaches a fluid collection device and is thus considered analogous to the claimed invention. Steer teaches that the device comprises an outlet pipe (figure 5,7,8 (pipe 12)) where said pipe comprises a series of ridges (44) which allows for fit with a drainage tube. The examiner notes that as a means to aid in attaching a drainage tube to the collection interface, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a series of ridges on the outlet of the device. The examiner notes that said ridges are interpreted as a tactile indicator including a bump on the exit hose (where the ridges are a bump themselves and would further form a bump in the tube when connected) and as such read to the claimed limitation.
Regarding claim 23, Davis, Johannes, Levinson, Hirsch, Street, Lawrence, Steer, and Austermann teach
The bladder relief system of claim 17, wherein the tactile indicator comprises at least a raised bump on the exit hose. The examiner notes that per the rejection of claim 17 in view of Street, the tactile indicator comprises at least a raised bump on the exit hose.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Johannes, Street, Austermann, Lawrence, and Steer and further in view of Cheng et al. US 2001/0037097, hereafter, Cheng.
Regarding claim 18, Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, wherein Davis teaches that the tube has an adjustable shape (para. 0063), however, fails to disclose wherein the exit hose comprises flat tubing.
Cheng teaches a urine management system and is thus considered analogous to the claimed invention. Cheng teaches that the device comprises a tubing for conveying fluid, where the tubing is a flat tube such that the tube can conform to the body of the wearer, expands as flow rate increases, shrinks and flattens as flow drops off, and is useful in preventing kinks (abstract, para. 0047). Therefore, as Cheng teaches that flat tubing is known in the art for adjusting size based on flow rate and conforming to the body, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make the adjustable tubing of Davis a flat tubing as a matter of simple substitution, as Davis teaches an adjustable tubing.
The examiner notes that for the intent of compact prosecution, the specification provides no criticality to the flat tubing of the claim. Per the specification of the instant application, paragraph 0044, the tubing may come in various forms, including inflatable tubing, flat tubing, corrugated tubing, spiral wire tubing, coiled tubing etc. Therefore the substitution of one type of tubing for the flat tubing would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention. (per figure 11d, the tubing of Davis is corrugated).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Johannes, Levinson, Hirsch, Street, Lawrence, and Austermann, and further in view of Cheng.
Regarding claim 20, Davis, Johannes, Newton, Hirsch, Street, Austermann Lawrence, and Steer teach
The bladder relief system of claim 17, wherein Davis teaches that the tube has an adjustable shape (para. 0063), however, fails to disclose wherein the exit hose comprises flat tubing.
Cheng teaches a urine management system and is thus considered analogous to the claimed invention. Cheng teaches that the device comprises a tubing for conveying fluid, where the tubing is a flat tube such that the tube can conform to the body of the wearer, expands as flow rate increases, shrinks and flattens as flow drops off, and is useful in preventing kinks (abstract, para. 0047). Therefore, as Cheng teaches that flat tubing is known in the art for adjusting size based on flow rate and conforming to the body, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make the adjustable tubing of Davis a flat tubing as a matter of simple substitution, as Davis teaches an adjustable tubing.
The examiner notes that for the intent of compact prosecution, there is no criticality to the flat tubing of the claim. Per the specification of the instant application, paragraph 0044, the tubing may come in various forms, including inflatable tubing, flat tubing, corrugated tubing, spiral wire tubing, coiled tubing etc. Therefore the substitution of one type of tubing for the flat tubing would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention. (per figure 11d, the tubing of Davis is corrugated).
Claim(s) 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Johannes, Street, Lawrence ,Steer, and Austermann and further in view of Otto US 2007/0225668, hereafter Otto.
Regarding claim 24 Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, but fail to teach wherein the pump includes a motor speed control feature configured to limit rev during intermittent flow conditions to maintain smooth and quiet operation.
Otto teaches a urine collection device and is thus considered analogous to the claimed invention. Otto teaches that the urine collection system includes a panel that allows the user to operate the system and receive statuses about the system (para. 0020). Per para. 0059, the motor of the pump is calibrated to control a flow rate at a set level, where the flow rate is adjustable by the user. Further per para. 0056, Otto teaches that the panel comprises visual indicators for various conditions, including “RESERVOIR” indicating that the reservoir is full and the device stops operation. Therefore as a means to ensure proper operation of the device and monitor the system, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement to monitoring system of Otto with the prior art device. The examiner notes that user control of the flow rate where the flow rate (per Otto para. 0059) is directly indicative of the motor speed is interpreted as user control of the motor. The examiner further notes that the device of Otto is configured to operate quietly (para 0075), however should applicant disagree that the device of the prior art in view of Otto fails to teach that the device limits rev during intermittent flow conditions to maintain smooth and quiet operation, the examiner notes that “"[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) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as
the prior art device in view of Otto teaches urine collection device with a structure that is found to be equivalent to the claimed invention, and comprises a control system for controlling the motor speed, where the device is configured to be quiet, and the use during intermittent flow conditions to maintain smooth and quiet operation is functional language, the prior art combination would read to said functional language.
Regarding claim 25 Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, however fails to specifically disclose wherein the pump is user activated.
Otto teaches a pump based urine collection system urine collection system and is thus considered analogous to the claimed invention.
Per applicant’s amendments and arguments that Otto fails to teach that the pump is activated and deactivated by the user where the user input comprises one or more of a button and switch, configured for glove-operable actuation, the examiner notes that Otto teaches this limitation. The rejection has been updated. Per paragraph 0056, Otto discloses a manual operating mode in which a power button is required to be pressed to turn on the pump. If the button is pressed again, the pump is turned off. Thus Otto teaches a user activated pump where the input is a button press. The examiner notes that as Otto teaches pump based urine collection devices may be manually operated by a button, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a power button for the pump of the previously combined prior art device. Doing so would merely involve combining prior art elements (pump system with a button [taught to activate pump systems)) according to known methods to yield predictable results, that being manual operation of the pump, and thus a prima facie case of obviousness exists.
Should applicant argue that Otto does not teach that the device is “configured for glove operated actuation”, the examiner notes that the examiner notes that per the MPEP
section 2114 section II “"[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)
(emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed
apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art
apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as
the prior art combination a urine collection device with a structure that is found to be equivalent to the claimed invention, where the device is manually operated by pressing a button, and that manual operation by a glove is interpreted as functional language, the prior art combination would read to said functional language, as the button would reasonably be able to be pressed by a gloved hand.
Regarding claim 26 Davis, Johannes, Street, Austermann, Lawrence, and Steer teach
The bladder relief system of claim 1, further comprising a visual indicator configured to signal active operation of the pump and provide a blockage alert.
Otto teaches that the urine collection system includes a panel that allows the user to operate the system and receive statuses about the system (para. 0020). Per para. 0059, the motor of the pump is calibrated to control a flow rate at a set level, where the flow rate is adjustable by the user. Per para. 0056, Otto teaches that the panel comprises visual indicators for various conditions, including “RESERVOIR” indicating that the reservoir is full at which the device stops operation, and pump on/off. The examiner notes that pump on/off lights are visual indicators of active operation, and the reservoir full indicating light is indicative of a blockage due to the operation of the device shutting down, thus blocking normal operation. Therefore as a means to ensure proper operation of the device and monitor the system, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement to monitoring system including the visual indicators of Otto with the prior art device.
Conclusion
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781