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 .
Applicant' s arguments, filed 10/31/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 10/31/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 4-5, 7-14, 21-25, and 27-31 are the currently pending claims hereby under examination. Claims 1-3, 6, 15- 20, and 26 have been canceled. Claim 21 has been amended and claims 28-31are new.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/31/2025 has been entered.
Claim Objections
Claim 31 is objected to because of the following informalities:
In claim 31, lines 48–51: the multi-sensor array clause recites "color detection sensors positioned along the input tube configured to detect color changes and blood detection through reduced light transmission using photovoltaic cells and light sources electronic scale systems integrated within a base unit" without clear punctuation, such as a semicolon, between "light sources" and "electronic scale systems".
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 29 and 31 are 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.
Claim 29 recites "the system further comprising automatic safety mechanisms wherein removal of the collection container immediately cuts off fluid flow by the connected valve entering into a fluid-closed state" (lines 6-8). It is unclear what specific structural components constitute the "automatic safety mechanisms", whether they are distinct from the "connected valve", and how they are implemented within the claimed system. As drafted, the term "automatic safety mechanisms" operates as a broad functional description without definite structural boundaries or clearly identified corresponding structure, rendering the scope of claim 29 uncertain. The term “automatic safety mechanisms” does not appear in the specification and is not used therein as a term of art or as a label for any particular hardware or subassembly. The specification only describes automatic shutoff behavior in terms of the valve or valve assembly entering a closed state upon removal of the collection container, but does not identify any separate “automatic safety mechanism” apart from the valve itself. Thus, it is unclear whether “automatic safety mechanisms” is intended to be limited to the connected valve, or to some broader or different structure not expressly disclosed. For purposes of examination, the Examiner is interpreting “automatic safety mechanisms” as being implemented by the connected valve that automatically enters a fluid-closed state upon removal of the collection container. However, Applicant is advised that if “automatic safety mechanisms” is intended to encompass structure beyond the connected valve, the term would be subject to interpretation under 35 U.S.C. § 112(f) as a purely functional, non-structural “mechanism” limitation without clearly identified corresponding structure in the specification, which would render the claim indefinite. Applicant is therefore encouraged to amend the claim to either delete “automatic safety mechanisms” or to expressly recite that the automatic safety mechanism is the connected valve (or otherwise identify the specific structural components that constitute the mechanism).
Claim 31, line 1 recites "A comprehensive healthcare fluid monitoring and collection system" which employs the relative term "comprehensive" that renders the claim indefinite. The term “comprehensive” 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 not clear how one judges a system to be comprehensive. What metrics are used? How are those metrics judged? The applicant is advised to delete "comprehensive" or replace it with more objective structural language.
Claim 31, line 45 recites "a comprehensive multi-sensor array“ which employs the subjective term "comprehensive" which does not add definite structural meaning. Also, the term is a relative term which renders the claim indefinite. The term “comprehensive” 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 not clear how one judges a system to be comprehensive. What metrics are used? How are those metrics judged? The applicant is advised to delete "comprehensive" or replace it with more objective structural language;
Claim 31 recites "to facilitate uninterrupted fluid collection by automatically directing flow to a second collection container when a first collection container becomes full" (lines 62-63). The claim previously introduces "at least one collection container" (line 35) but does not provide antecedent basis for "a first collection container" and "a second collection container," nor does it clearly define the relationship between these containers and the previously recited "at least one collection container." As drafted, it is unclear whether multiple distinct containers are required, how they relate to the earlier "at least one collection container," and how flow is automatically directed between them, thereby rendering the scope of claim 31 indefinite. The Examiner is interpreting claim 31 as requiring at least two distinct collection containers (i.e., a first collection container and a second collection container of the type recited in lines 35–44) where the system is capable of automatically redirecting fluid flow from the first to the second collection container when the first becomes full; however, because this relationship is not clearly and consistently set forth in the claim language, the metes and bounds of claim 31 remain indefinite.
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.
Claim 21 is rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Song et al. (CN208726362U), hereto referred as Song.
Regarding claim 21, Goldberg teaches that a bodily fluid collection system (Goldberg, FIG. 1, 4; col. 3, Il. 3-16: "drainage device is coupled to a subject so that fluid flows from the patient into the manifold... to direct the fluid into one of the containers, and fluid is allowed to collect in this container", demonstrating a bodily fluid collection system) comprises: a hollow input tube (Goldberg, FIG. 1; col. 2-3, Il. 59-2: "the manifold may be connected to a drainage catheter which is conventionally located to drain urine from the bladder of a human subject", where the catheter 62 is a hollow tube used as an input tube from the bladder to the manifold) having: an inlet configured to receive fluid from a fluid source (Goldberg, FIG. 1; col. 2-3, ll. 59-2: "a drainage catheter which is conventionally located to drain urine from the bladder of a human subject", demonstrating the tube receiving fluid from a fluid source, where a catheter implicitly has an inlet); and a tube output configured to output the received fluid (Goldberg, FIG. 1: depicts the catheter with an output connected to port 50 of the manifold, to output the fluid into the manifold); a valve assembly (Goldberg, FIG. 1, where the combination of the manifold 10 and the valved output ports 30 with valves 40 makes up the valve assemble) comprising: an input tube configured to receive fluid from the tube output of the hollow input tube (Goldberg, FIG. 1; col. 2-3, IL. 59-2: "The drainage device of this invention includes a central manifold adapted for connection to a source of body fluid..."; col. 5, Il. 25-43: "This drainage manifold 10 is a generally tubular structure which is provided with a valved input port 50 and four valved output ports 30"; col. 5, II. 44-51: "input port 50 is adapted for connection to a catheter 62 which is in turn coupled to a source of body fluid"; where the tubular manifold acts as the input tube receiving fluid from the drainage catheter via port 50); the input tube defining a primary flow channel extending from a first terminal end to a second terminal end (See annotated figure below; Goldberg, FIG. 1; col. 2-3, Il. 59-2; col. 5, Il. 25-43: Goldberg describes the drainage manifold 10 as a generally tubular structure which is adapted for connection to a catheter 62 and which distributes body fluid to a plurality of valved output ports 30. The interior of manifold 10 defines a continuous flow passage extending between opposite terminal ends of the tube, so that urine entering through input port 50 flows along this primary flow channel and past the output ports 30 to whichever ports are opened. Under a broadest reasonable interpretation, the tubular interior of manifold 10 constitutes the claimed primary flow channel extending from a first terminal end of the tube to an opposite second terminal end. Thus, this element is anticipated by Goldberg. Alternatively, to the extent a more restrictive interpretation is applied requiring a manifold having only two valved output locations at or near the respective terminal ends, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to omit unused intermediate ports and employ only those ports necessary for connection to two collection containers, consistent with routine design considerations for simplifying fluid routing and reducing component use. Furthermore, Goldberg's manifold does not require that every intermediate port or associated valve be used in any given clinical configuration. As shown in figure 1, Goldberg explicitly depicts only a single drainage bag deployed to the manifold while the remaining output ports, valve structures, and bags remain unused, yet the system continues to function as intended (Goldberg, FIG. 1). The figure therefore demonstrates that the unused intermediate ports perform no required function when fluid is being directed to only one (or only two) collection containers and that the manifold is fully operative even when most ports are not fluidly connected to bags. Under MPEP § 2144.04, omission of an element is an obvious modification where the omitted element does not perform a function necessary to the combination. Here, because Goldberg's unused intermediate ports are optional and contribute no necessary function in a two-container configuration, it would have been an obvious design choice to omit the unused ports and retain only those ports needed to connect two containers while preserving the same continuous tubular flow path extending between the manifold’s terminal ends. The benefit would be simplifying the device and reducing manufacturing cost by reducing the number of valves and port structures while preserving the same flow control functionality. (See MPEP: 2144.04: Omission of an Element and Its Function Is Obvious if the Function of the Element Is Not Desired and/or Omission of an Element with Retention of the Element's Function Is an Indicium of Nonobviousness)); a first valve in fluid communication with the input tube at a first position along the primary flow channel proximate to a first terminal end of the input tube (Goldberg, FIG. 1; col. 5, Il. 25-43, 60-66: manifold 10 is a tubular member with multiple valved output ports 30 spaced along its length, each port including a valve 40 that opens into the interior of the manifold; at least one of these valved ports 30 is positioned nearest one terminal end of manifold 10 and thus lies at a first position along the primary flow channel proximate to that terminal end) and having: a valve output (Goldberg, FIG. 1; col. 3, Il. 3-16: "The valves are positioned to direct the fluid into one of the containers..."; showing that the valves implicitly have an output as they are connected to containers 20 which collect the fluid that comes out of the valves); and a flow control mechanism configured to regulate fluid flow between the valve input and valve output (Goldberg, FIG. 1, col. 5, Il. 60-66: "Each of the valved output ports 30 includes a valve 40 which operates to selectively seal the port 30", showing that valve 40 (i.e. fluid control mechanism) regulates the fluid flow between the input and output of the valved output port 30); a second valve in fluid communication with the input tube positioned at a second position along the primary flow channel, the second position being further down the input tube from the first position and proximate to a second terminal end (See annotated figure below; Goldberg, FIG. 1; col. 5, Il. 25-43, 60-66: Goldberg's manifold 10 includes additional valved output ports 30 spaced farther along the tubular interior away from the first terminal end and nearer the opposite terminal end; the furthest-used port 30 and its valve 40 are therefore located at a second position farther along the same primary flow channel from the first valve and proximate to the opposite terminal end of the manifold) and having: a valve output (Goldberg, FIG. 1; col. 3, Il. 3-16: "The valves are positioned to direct the fluid into one of the containers..."; showing that the valves implicitly have an output as they are connected to containers 20 which collect the fluid that comes out of the valves); and a flow control mechanism configured to regulate fluid flow between the valve input and valve output (Goldberg, FIG. 1, col. 5, ll. 60-66: "Each of the valved output ports 30 includes a valve 40 which operates to selectively seal the port 30", showing that valve 40 (i.e. fluid control mechanism) regulates the fluid flow between the input and output of the valved output port 30); wherein the first and second valves are configured to independently control fluid flow through the respective valve outputs (Goldberg, FIG. 1; col. 3, ll. 3-16: "...the associated valve is then closed in order to isolate this fluid filled container from the manifold, and the associated conduit is severed... another valve is opened to allow fluid to collect in another container"; Although Goldberg describes a preferred use in which one valve is opened at a time, each valve 40 is structurally configured for independent actuation, with no mechanical dependence between them. Thus, they are configured to independently control fluid flow through their respective valve outputs); at least one collection container comprising: a fluid bag defining a water-tight interior (Goldberg, col. 5, Il. 25-43: "containers 20 are shown collapsed and folded for storage into small packets and one of the containers 20a is shown unfolded, ready to receive fluid from the manifold 10. Preferably, each container is formed of a flexible, plastic material such as vinyl, polyethelene, or some other suitable material", where the containers are described as col. 6-7, Il. 54-7 "two-liter bags"; demonstrating multiple collection containers, made from such materials to create a water-tight fluid bag) and a connector having: an input configured to removably connect to one of the valve outputs (Goldberg, col. 5-6, Il. 61-18: "Each container 20 includes a narrow neck region 24 which is sealed to one of the input ports 30", col. 3, ll. 3-30: "The fluid filled container is then removed for testing or disposal", where the neck region 24 functions as the claimed connector, having an input end that attaches to the valve output (i.e., port 30) and an output end fixed to the fluid bag; Although the term "sealed" implies a semi-permanent connection, Goldberg explicitly states that the container is removed from the manifold for testing or disposal, indicating that the connection is removably connected to the valve); and an output fixed to the fluid bag and defining a lumen fluidically connected to the interior of the fluid bag (Goldberg, col. 5-6, Il. 61-18: "Each container 20 includes a narrow neck region 24 which is sealed to one of the input ports 30"; the output of neck region 24 is fixed to the fluid bag and defines an internal passageway (i.e. lumen) fluidically connected to the bag's interior).
Also regarding claim 21, Goldberg does not fully teach that a pressure control valve is fluidically connected to the inlet, having a user-adjustable pressure flow setting, and being configured to permit flow of the fluid into the inlet only when the fluid is at a pressure above the user-adjustable pressure flow setting. Goldberg teaches that the input port 50 "includes a valve 60 which operates to selectively seal the port 50" (Goldberg, col. 5, ll. 52-56, see also FIG. 4), so that valve 60 is fluidically connected between catheter 62 (the inlet from the bladder) and the manifold 10. However, Goldberg does not describe valve 60 as providing an adjustable pressure-opening setting.
Flinchbaugh, in contrast, teaches a low-pressure fluid flow control magnetic valve for emptying the bladder through a catheter, in which the externally adjustable screw controls the separation between magnets to provide "a significant degree of valve pressure opening adjustment, or variable pressure setting, which can be desirable in certain situations" (Flinchbaugh, col. 6-7, ll. 59-24; see also Abstract).
It would have been prima facie obvious before the effective filing date of the claimed invention to implement the valved input port 50 of Goldberg as a Flinchbaugh-type user-adjustable pressure-control valve so that urine begins flowing from catheter 62 into manifold 10 only when the fluid pressure exceeds a user-selected threshold. Both references address controlling urine drainage from the bladder through a catheter, and substituting a known user-adjustable pressure-operated valve at Goldberg's known valved input location represents a simple substitution of one known valve type for another to achieve the predictable result of permitting flow only when the pressure exceeds the selected setting. This has the benefit of allowing clinicians to tailor the opening pressure to patient-specific bladder and catheter conditions, avoiding continuous low-pressure drainage and instead promoting more physiologic cyclic filling and emptying while still providing automatic pressure-activated drainage when the selected threshold is reached.
Also regarding claim 21, Goldberg does not fully teach that the connector has a one-way container valve integrated into a removable connector. Rather, Goldberg describes a connector for attaching a collection container, as shown above, but does not disclose a one-way valve configured to prevent backflow out of the removable connector.
Song, however, teaches a urine collection system in which a first one-way valve 501 is disposed in a fixed sleeve 5 between the drainage tube 503 and the urine bag 1, such that "under the action of the first one-way valve 501, the urine in the fixed sleeve 5 cannot flow back into the drainage tube 503" when the connector assembly is used and disconnected (Song, FIG. 2, [0023]), thereby providing a one-way valve integrated into the connector assembly between the drainage tube and the urine bag to prevent backflow toward the patient.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify Goldberg in view of Song to provide a removable connector of the collection container having an integrated one-way container valve configured to prevent backflow out of the connector. This modification is possible because Goldberg's connector (neck region 24) is a tubular structure that serves as the interface between the container and the manifold, and is configured for removable connection. One-way valves, such as check valves, are commercially available in compact forms specifically designed to fit inside or as part of standard medical connectors and tubing. A person of ordinary skill in the art would recognize that incorporating such a one-way valve into the neck region of Goldberg's connector would require only selecting an appropriately sized commercial component or integrating a molded valve element into the connector during manufacturing, both of which are straightforward and established engineering practices in the medical device field. Goldberg's express motivation to maintain sterility and maintain a closed, contamination-free system (see, e.g., col. 6, ll. 19-32) would encourage a person of ordinary skill in the art to adopt such a feature, as a one-way valve would further minimize fluid exposure and backflow, directly advancing Goldberg's goal of maintaining sterility. The benefit of this combination is to prevent contamination through backflow and fluid leakage when the container is detached, improving safety and sterility, a predictable use of known technology in fluid collection systems.
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Annotated Figure 1
Claims 4 and 27 are rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Song et al. (CN208726362U), hereto referred as Song, and further in view of Russo et al. (US 20030195478 A1), hereto referred as Russo.
The modified Goldberg teaches claim 21 as described above.
Regarding claim 4, the modified Goldberg does not disclose that the at least one collection container is a modular set with each connected to one of the first and second outputs, permitting either container to be in either of the flow-on and flow-off states while the other container is independently in either state. Rather, the modified Goldberg describes a system with multiple collection containers and valves, as shown above in claim 21, but does not disclose that each collection container is independently connected to one of the outputs with a valve that automatically transitions between flow-on and flow-off based on container attachment, or that both containers can be in the flow-on state when attached. Russo, however, teaches a valve system in which each valve is independently actuated to the flow-on state upon connection of a container and returns to flow-off when disconnected (Russo, ¶[0061]–[0062]).It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg, Flinchbaugh, and Song in view of Russo to implement a system in which each modular collection container is independently connected to one of the outputs and each output has a valve that automatically allows fluid flow upon connection and closes upon disconnection. The combination is possible because Goldberg’s system already provides for multiple valves and removable connections, and adapting Russo’s connection-responsive valve for each output would only require routine engineering modification. The benefit of this combination is enhanced fluid collection efficiency, the ability to collect fluid in multiple containers simultaneously or independently, and improved ease of use by reducing manual switching and risk of error.
Regarding claim 27, the modified Goldberg does not fully teach that the first and second valves each have a steady state in a flow-off state and are configured such that connection of the collection container to one of the valve outputs automatically places the connected valve in a flow-on state, and disconnection of the collection container from the valve output automatically returns the valve to the flow-off state. Goldberg describes manually actuated valves, as shown in claim 21, but does not disclose automatic valve actuation in response to connection or disconnection of a container. Russo, however, teaches a valve that has a steady state in the flow-off position and is automatically moved to a flow-on state by insertion of a connector, and returns to flow-off when the connector is removed (Russo, ¶[0061]–[0063]). It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg, Flinchbaugh, and Song in view of Russo to provide a valve that automatically switches to a flow-on state upon connection of a collection container and returns to flow-off upon disconnection. This modification is possible because Goldberg’s connector (neck region 24) is a tubular, removable interface between the container and the manifold (Goldberg, col. 5, ll. 61–18). Russo describes a valve that is opened by insertion of a mating connector (male luer 36 into female luer 32) and automatically closes when the connector is removed (Russo, ¶[0062]). Both Goldberg and Russo disclose connectors designed for removable attachment of fluid containers in medical systems. A person of ordinary skill in the art would have recognized that the automatic valve mechanism of Russo could be implemented in the removable connector interface of Goldberg by incorporating a valve biased to the closed position and actuated by the presence of a mating connector, as expressly taught by Russo. This approach would further Goldberg’s goal of maintaining a sterile, closed system during fluid collection and disposal (Goldberg, col. 6, ll. 19–32).The benefit of this combination is to enhance sterility and safety by eliminating the need for manual valve operation during bag changes, reducing the risk of leakage and contamination.
Claim 5 is rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Song et al. (CN208726362U), hereto referred as Song, and further in view of Russo et al. (US 20030195478 A1), hereto referred as Russo, and further in view of Wolff et al. (US 20020087131 A1), hereto referred as Wolff.
The modified Goldberg teaches claim 21 as described above.
Regarding claim 5, the modified Goldberg does not teach that the at least first and second collection containers are configured such that, responsive to the interior of one of the at least first and second collection containers being full, flow of the input fluid is directed to the other of the at least first and second collection containers. Rather, the modified Goldberg teaches a bodily fluid collection system with multiple containers and valves, as shown above in claim 4, but does not teach that, responsive to the interior of one of the collection containers being full, fluid flow is automatically redirected to the other container. Instead, the modified Goldberg requires manual closure of one valve and opening of another (Goldberg, col. 6, ll. 44–56). Wolff, however, teaches a fluid collection system in which a valve is automatically opened or closed based on sensor detection of fluid, thus enabling the system to redirect flow automatically without manual intervention (Wolff, ¶[0025], ¶[0026]). It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg and Russo in view of Wolff to provide for the automatic redirection of fluid flow to a second collection container responsive to the first collection container being full. Goldberg’s independently operable valves could be replaced or supplemented with sensor-controlled solenoid valves as taught by Wolff, allowing the system to detect when a container is full (as the sensor detects fluid or not at the top of the bag) and automatically open the next valve to redirect flow. The combination is possible because both systems utilize fluid-tight valves to control fluid routing and are physically compatible. The benefit of this combination is to enable automatic, uninterrupted fluid collection, minimize the risk of overflow or user error, and enhance patient safety and ease of use. This represents a predictable improvement using known technology, requiring only routine adaptation by one skilled in the art.
Claims 23 and 25 are rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Song et al. (CN208726362U), hereto referred as Song, and further in view of Wolff et al. (US 20020087131 A1), hereto referred as Wolff.
The modified Goldberg teaches claim 21 as described above.
Regarding claim 23, the modified Goldberg does not teach that the at least one collection container includes a first container and a second container and the first and second collection containers are configured such that, responsive to the interior of the first collection container being full, flow of the fluid is automatically directed to the second collection container. Rather, the modified Goldberg teaches a bodily fluid collection system with multiple containers and valves, but does not teach that, responsive to the interior of the first container being full, fluid flow is automatically redirected to the second container. Instead, the modified Goldberg requires manual closure of one valve and opening of another (Goldberg, col. 6, ll. 44–56). Wolff, however, teaches a fluid collection system in which a valve is automatically opened or closed based on sensor detection of fluid, thus enabling the system to redirect flow automatically without manual intervention (Wolff, ¶[0025], ¶[0026]). It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg, Flinchbaugh, and Song in view of Wolff to provide for the automatic redirection of fluid flow to a second container responsive to the first container being full. Goldberg’s independently operable valves could be replaced or supplemented with sensor-controlled solenoid valves as taught by Wolff, allowing the system to detect when a container is full (as the sensor detects fluid or not at the top of the bag) and automatically open the next valve to redirect flow. The combination is possible because both systems utilize fluid-tight valves to control fluid routing and are physically compatible. The benefit of this combination is to enable automatic, uninterrupted fluid collection, minimize the risk of overflow or user error, and enhance patient safety and ease of use. This represents a predictable improvement using known technology, requiring only routine adaptation by one skilled in the art.
Regarding claim 25, the modified Goldberg does not teach that at least one of the first and second valves comprises a sensor receiver configured to receive sensor data and direct fluid flow based upon the received sensor data. Goldberg teaches a bodily fluid collection system with multiple containers and valves, but does not teach that any valve includes a sensor receiver, receives sensor data, or is configured to direct fluid flow based upon received sensor data. Instead, the modified Goldberg requires manual operation of the valves (Goldberg, col. 6, ll. 44–56). Wolff, however, teaches a fluid collection system in which a valve is automatically opened or closed based on sensor detection of fluid, thus enabling the system to redirect flow automatically without manual intervention (Wolff, ¶[0025], ¶[0026]). It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg, Flinchbaugh, and Song in view of Wolff to provide at least one valve comprising a sensor receiver configured to receive sensor data and direct fluid flow based upon received sensor data. Goldberg’s independently operable valves could be replaced or supplemented with sensor-controlled solenoid valves as taught by Wolff, allowing the system to detect the presence or absence of fluid (at the top of the bag as it is full or not) and control the valve accordingly. The combination is possible because both systems utilize fluid-tight valves to control fluid routing and are physically compatible. The benefit of this combination is to enable automatic, uninterrupted fluid collection, minimize the risk of overflow or user error, and enhance patient safety and ease of use. This represents a predictable improvement using known technology, requiring only routine adaptation by one skilled in the art.
Claims 7-9 are rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Song et al. (CN208726362U), hereto referred as Song, and further in view of Elia et al. (US 20200253530 A1), hereto referred as Elia.
The modified Goldberg teaches claim 21 as described above.
Regarding claim 7, the modified Goldberg does not teach that the system further comprises a fluid monitoring system connected to the hollow tube and configured: to measure fluid output; and to transmit data associated with the fluid output to a receiver to permit direct reading of the fluid output. Rather, the modified Goldberg describes a fluid collection system as described in claim 21 above, but does not disclose a fluid monitoring system connected to the hollow tube that can measure fluid output and transmit associated data to a receiver for direct reading. Elia discloses a urine analysis device that detects urine flow using a drip chamber and sensor, providing real-time volume measurement and transmission of the data for bedside monitoring (Elia, FIG. 4 and ¶[0016]) and will even transmit alerts about flow data to a smartphone (Elia, ¶[0148]). This system enables precise urine monitoring by analyzing individual drops and estimating their respective volumes before outputting the data to an interface, ensuring automated and accurate fluid tracking. Elia’s inline functionality, which enables real-time urine flow analysis and automated data transmission, would seamlessly integrate into Goldberg’s system by enhancing its monitoring capabilities with precise, continuous fluid output tracking and instant alert generation, thereby reducing manual intervention and improving patient management (Elia, ¶[0016]). It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg, Flinchbaugh, and Song in view of Elia to incorporate a fluid monitoring system capable of real-time fluid output measurement and data transmission. A skilled person would recognize the benefit of ensuring automated and precise fluid tracking to reduce manual monitoring errors. The combination enhances fluid management, allowing immediate access to patient urine output trends. By integrating these features, the resulting system would improve efficiency in fluid monitoring while ensuring accurate measurement and transmission of urine output data. Given these advantages, a skilled person would have been motivated to implement this feature in a conventional system without requiring inventive skill.
Regarding claim 8, the modified Goldberg does not teach that the fluid monitoring system has a defined measurement range for the fluid output and is configured to indicate if the measured fluid output falls at least one of: within the defined measurement range; and outside the defined measurement range. Rather, the modified Goldberg describes a fluid collection system, as shown in claim 7 above, but does not disclose a fluid monitoring system that defines a measurement range for fluid output or provides alerts when output is outside the range. Elia discloses a urine monitoring system that defines a tolerance range for urine output and generates an alert when the measured output falls outside this range (Elia, ¶[0148]). The system further enables remote transmission of alerts to a mobile device or other computing interfaces for real-time monitoring (Elia, ¶[0148]). This functionality provides clear benefits for proactive fluid management and early intervention. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg, Flinchbaugh, and Song in view of Elia to incorporate a fluid monitoring system capable of defining a measurement range and alerting when fluid output is outside the defined range. A skilled person would recognize that such an implementation improves clinical monitoring efficiency and patient safety. The combination enables immediate awareness of abnormal fluid output trends, allowing timely medical response. By integrating these features, the resulting system would facilitate enhanced fluid monitoring with automated alerts and precise measurement capabilities. Given these advantages, a skilled person would have been motivated to implement this feature in a conventional system without requiring inventive skill.
Regarding claim 9, the modified Goldberg does not teach that the fluid monitoring system is configured to transmit and remotely create an alarm if the measured fluid output is outside the defined measurement range. Rather, the modified Goldberg describes a fluid collection system, as shown in claims 7 and 8 above, but does not disclose a fluid monitoring system that is configured to transmit and remotely create an alarm if the measured fluid output is outside a defined measurement range. Elia discloses a urine monitoring system capable of generating and transmitting an alarm when the urine output falls outside a predefined tolerance range (Elia, ¶[0148]). The system supports remote notifications by transmitting alerts to a mobile device or computing interface, ensuring timely intervention when urine output deviates from expected values. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg, Flinchbaugh, and Song in view of Elia to incorporate a fluid monitoring system capable of transmitting alarms when fluid output is outside the defined measurement range. A skilled person would recognize that automating such alerts enhances clinical response times, reducing the risk of undetected fluid imbalances. By integrating these features, the resulting system would provide enhanced fluid monitoring with automated alarms and real-time notifications, improving patient safety and clinical efficiency. Given these advantages, a skilled person would have been motivated to implement this feature in a conventional system without requiring inventive skill.
Claim 10 is rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Song et al. (CN208726362U), hereto referred as Song, and further in view of Mantinband et al. (US 20170367636 A1), hereto referred as Mantinband.
The modified Goldberg teaches claim 21 as described above.
Regarding claim 10, the modified Goldberg does not teach that the system further comprises a fluid monitoring system connected to the hollow tube and configured: to measure at least one of fluid color and fluid transparency; and to transmit data associated with the measurement of the at least one of fluid color and fluid transparency to a receiver to permit direct reading of the at least one of fluid color and fluid transparency. Rather, the modified Goldberg describes a manual fluid collection system but does not disclose a fluid monitoring system that provides automated measurement of fluid color or transparency or transmits these data for direct or remote reading. It does not include inline sensors for detecting fluid color or fluid transparency or transmitting alerts. Mantinband discloses an inline urine analysis system equipped with an image capture unit and optical assembly for real-time measurement of urine properties, including color and clarity/turbidity (Mantinband, ¶[0021], ¶[0081]). This ensures real-time color and transparency assessment, enhancing diagnostic accuracy. Mantinband further discloses a system that transmits urine analysis data, including color and transparency measurements, to a remote receiver such as a phone or computer, allowing real-time tracking of urine characteristics (Mantinband, ¶[0076]). This feature enables immediate intervention when abnormal conditions are detected. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg, Flinchbaugh, and Song in view of Mantinband to incorporate a fluid monitoring system capable of measuring urine color and transparency while also transmitting this data to a receiver. A skilled person would recognize the benefit of automated color detection alongside existing urine flow monitoring, reducing manual observation errors and improving real-time diagnostics. This modification is possible because Mantinband’s system is designed to interface with urine catheter pathways and can be readily integrated into Goldberg’s fluid collection system. By integrating these features, the resulting system would enhance fluid monitoring by providing automated color and transparency analysis with real-time notifications, improving diagnostic accuracy and patient management. Given these advantages, a skilled person would have been motivated to implement this feature in a conventional system without requiring inventive skill.
Claims 11-12 are rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Song et al. (CN208726362U), hereto referred as Song, and further in view of Mantinband et al. (US 20170367636 A1), hereto referred as Mantinband, and further in view of Gunawan et al. (Gunawan, Alexander A S et al. “Development of Urine Hydration System Based on Urine Color and Support Vector Machine.” Procedia computer science 135 (2018): 481–489. Web.), hereto referred as Gunawan.
The modified Goldberg teaches claim 21 as described above.
Regarding claim 11, the modified Goldberg does not teach that the fluid monitoring system has a defined measurement range for the at least one of fluid color and fluid transparency and is configured to indicate if the at least one of the measured fluid color and the measured fluid transparency falls at least one of: within the defined measurement range; and outside the defined measurement range. Rather, the modified Goldberg describes a manual fluid collection system but does not disclose a fluid monitoring system that automatically measures fluid color or transparency, defines measurement thresholds, or provides alerts/indications when a value is outside a set range. Mantinband discloses an inline urine analysis system that evaluates urine properties, including color and transparency, and identifies properties of interest, implying a defined range of normality (Mantinband, ¶[0081]). This ensures real-time assessment of urine characteristics within clinically relevant thresholds. Gunawan explicitly discloses a predefined measurement range for urine color, presenting a standardized color scale for hydration assessment (Gunawan, Fig. 2). Since Gunawan’s predefined color scale is derived from urine test strips rather than direct urine samples, its integration with Mantinband’s inline optical analysis system would require calibration adjustments. A skilled person would recognize that the color responses on test strips differ from free-flowing urine; however, the structured color scale in Gunawan could still serve as a reference framework within Mantinband’s system, enabling real-time optical comparisons by adjusting for baseline differences. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg, Flinchbaugh, and Song in view of Mantinband and Gunawan to incorporate a fluid monitoring system capable of determining when urine color or transparency falls outside an expected range and generating an indication of such deviations. A skilled person would recognize the benefit of automated threshold-based monitoring to ensure timely clinical intervention. By integrating these features, the resulting system would enhance fluid monitoring with precise range-based assessment and real-time alerts, improving diagnostic accuracy and patient safety. Given these advantages, a skilled person would have been motivated to implement this feature in a conventional system without requiring inventive skill.
Regarding claim 12, the modified Goldberg does not teach that wherein the fluid monitoring system is configured to transmit and remotely create an alarm if at least one of the measured fluid color and measured fluid transparency is outside the defined measurement range. Rather, the modified Goldberg describes a manual fluid collection system, as discussed above, but does not disclose a fluid monitoring system that provides automated transmission or remote alarms for fluid color or transparency deviations. Mantinband discloses an inline urine analysis system that evaluates urine properties, including color and transparency, and identifies abnormalities based on deviations from expected values, implying a defined range of normality (Mantinband, ¶[0081]). This ensures real-time assessment of urine characteristics and enables transmission of relevant data for clinical review as well as alarms for changes of clinical interest (Mantinband, ¶[0117]). Gunawan explicitly discloses a predefined measurement range for urine color, presenting a standardized color scale for hydration assessment (Gunawan, Fig. 2). Since Gunawan’s predefined color scale is derived from urine test strips rather than direct urine samples, its integration with Mantinband’s inline optical analysis system would require calibration adjustments. A skilled person would recognize that the color responses on test strips differ from free-flowing urine; however, the structured color scale in Gunawan could still serve as a reference framework within Mantinband’s system, enabling real-time optical comparisons by adjusting for baseline differences. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg, Flinchbaugh, and Song in view of Mantinband and Gunawan to incorporate a fluid monitoring system capable of determining when urine color or transparency falls outside an expected range and generating an indication of such deviations. The alarm system in Mantinband, which is designed to notify healthcare providers when deviations in urine properties are detected, could be adapted to incorporate Gunawan’s predefined color scale by triggering alerts when urine color falls outside the expected range. Since Mantinband already transmits abnormal findings remotely, a skilled person would recognize that applying Gunawan’s structured color thresholds to Mantinband’s optical sensor system would allow automated alerts for out-of-range urine colors without requiring additional hardware changes. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Jin and Russo in view of Mantinband and Gunawan to incorporate a fluid monitoring system capable of determining when urine color or transparency falls outside an expected range and generating an indication of such deviations. Furthermore, Mantinband provides the means for transmitting these deviations to a remote receiver, and Gunawan’s predefined range further enables automated alerts when color or transparency deviates from expected values. A skilled person would recognize the benefit of automated threshold-based monitoring to ensure timely clinical intervention. By integrating these features, the resulting system would enhance fluid monitoring with precise range-based assessment and real-time alerts, improving diagnostic accuracy and patient safety. Given these advantages, a skilled person would have been motivated to implement this feature in a conventional system without requiring inventive skill.
Claim 13 is rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Song et al. (CN208726362U), hereto referred as Song, and further in view of Hanif et al. (US 3961529 A), hereto referred as Hanif.
The modified Goldberg teaches claim 21 as described above.
Regarding claim 13, the modified Goldberg does not teach that the system further comprises a hospital bed connector configured to secure at least one of the hollow tube, the first and second valves, and the at least one collection container to a hospital bed. Rather, the modified Goldberg describes a urine collection system that hangs from a connector as shown in Figure 1, but does not disclose a connector specifically designed to secure components to a hospital bed. Hanifl explicitly discloses a urine metering and collection system that is mounted onto a hospital bed for patient monitoring with hanger 49 (Hanifl, FIG. 1 and col. 5 , lines 25-45). This mounting mechanism is a straightforward and adaptable design that could be easily applied to any urine collection vessel to facilitate secure attachment in clinical settings. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg, Flinchbaugh, and Song in view of Hanifl to incorporate a hospital bed connector for securing the urine collection system. A skilled person would recognize that securing urine collection components to a hospital bed provides stability, reduces accidental disconnections, and facilitates patient monitoring in medical settings. By integrating these features, the resulting system would enhance urine monitoring stability and usability in hospital environments. Given these advantages, a skilled person would have been motivated to implement this feature in a conventional system without requiring inventive skill.
Claim 14 is rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Song et al. (CN208726362U), hereto referred as Song, and further in view of Købke et al. (US 20190231582 A1), hereto referred as Købke.
The modified Goldberg teaches claim 21 as described above.
Regarding claim 14, the modified Goldberg does not teach that the at least one collection container comprises a quantity of fluid-absorbing media within the interior. Rather, the modified Goldberg describes a urine collection system but does not disclose a collection container that includes a fluid-absorbing media. Købke, however, discloses a receptacle compartment that comprises a fluid-absorbent powder for stabilizing urine (Købke, ¶[0078]). This indicates an established method of incorporating absorbent materials into collection containers to manage and stabilize the collected fluid. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg, Flinchbaugh, and Song in view of Købke to incorporate a fluid-absorbing media within the collection container. A skilled person would recognize the benefit of stabilizing urine to prevent spillage, facilitate disposal, and control odor. The combination enhances fluid collection efficiency and hygiene in medical settings. By integrating these features, the resulting system would improve the management and stability of collected fluids while ensuring practical usability. Given these advantages, a skilled person would have been motivated to implement this feature in a conventional system without requiring inventive skill.
Claims 22 are rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Song et al. (CN208726362U), hereto referred as Song, and further in view of Manojlovic et al. (GB 2407989 A), hereto referred as Manojlovic.
Goldberg teaches claim 21 as described above.
Regarding claim 22, the modified Goldberg does not teach that the fluid bag interior is subdivided into at least two fluid-receiving compartments. Rather, the modified Goldberg discloses a fluid collection system using bags as described in claim 21 above, but it does not describe the interior of the collection container being subdivided into multiple fluid-receiving compartments. Manojlovic discloses a urine collection bag divided into multiple compartments to control expansion and improve distribution of fluid within the bag (Manojlovic, FIG. 3; p.5, lines 22–24). These compartments help prevent overdistension, reduce internal strain, and improve stability of the bag during filling. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Jin and Russo in view of Manojlovic to incorporate a collection container that is subdivided into multiple fluid-receiving compartments. A person of ordinary skill in the art would have found the modification feasible, as both references relate to urine collection bags used in medical settings, and the compartmentalization disclosed in Manojlovic is structurally compatible with the bags described in Goldberg. A skilled artisan would have been motivated to combine these teachings in order to improve fluid distribution, avoid localized bulging, minimize rupture risk, and enhance the structural integrity of the bag. The resulting system would provide more reliable and durable fluid handling, an important improvement for maintaining sanitary conditions and preventing leakage in clinical environments.
Claim 24 is rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Song et al. (CN208726362U), hereto referred as Song, and further in view of Augustine et al. (US 20200281790 A1), hereto referred as Augustine.
The modified Goldberg teaches claim 21 as described above.
Regarding claim 24, the modified Goldberg does not teaches that the system may further comprise a base unit including a scale configured to read a weight of the collection container and transmit weight data to a remote receiver. Goldberg teaches a bodily fluid collection system with collection containers, as shown above in claim 21, but does not disclose a base unit including a scale configured to read a weight of the collection container or the transmission of weight data to a remote receiver. Augustine, however, teaches a urine collection system wherein the urine bag is hung from an electronic scale that measures the weight of the bag and the urine within it, and further discloses that the scale may have a digital output reported to a patient monitor, processor, or electronic record, and may transmit this data to remote devices (Augustine, ¶[0171]-[0173]). It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Goldberg, Flinchbaugh, and Song in view of Augustine to provide a base unit including an electronic scale configured to read the weight of the collection container and transmit weight data to a remote receiver. In Goldberg, the support net (Goldberg, col. 5, ll. 25–43; Fig. 2) is attached to a hook, which is in turn attached to the input support of the manifold. A person of ordinary skill in the art would have recognized that the hook could be replaced or supplemented by a hanging electronic scale as taught by Augustine, enabling both weight measurement and remote data transmission. This modification is possible because both systems use suspended collection bags, and mounting the support net or bag on a digital scale with data output involves only routine substitution of one well-known support structure (hook) with another (scale with electronics). The benefit of this combination is improved accuracy in monitoring fluid output, as well as enabling remote or automated data collection, which enhances patient monitoring and reduces manual error.
Claims 28 and 30 are rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Song et al. (CN208726362U), hereto referred as Song, and further in view of Mantinband et al. (US 20170367636 A1), hereto referred as Mantinband, and further in view of Elia et al. (US 20200253530 A1), hereto referred as Elia, and further in view of Augustine et al. (US 20200281790 A1), hereto referred as Augustine.
The modified Goldberg teaches claim 21 as described above.
Regarding claim 28, the modified Goldberg does not teach a healthcare monitoring system that includes: a multi-sensor array comprising inline flow sensors configured to measure fluid output from the hollow input tube and digitally record the flow. Rather, the modified Goldberg describes a fluid collection system in which urine drains via a catheter and manifold into one of multiple collection bags (as shown in claim 21), but does not disclose any inline sensing hardware that measures fluid output or digitally records flow data; instead, the modified Goldberg relies on manual observation of collected volume in the containers and manual switching of valves between bags (Goldberg, col. 3; col. 5–6; col. 6, ll. 44–56).
Elia, however, discloses a urine analysis device that detects urine flow using a drip chamber and sensor, providing real-time volume measurement and transmission of the data for bedside monitoring (Elia, FIG. 4 and [0097]) and will even transmit alerts about flow data to a smartphone (Elia, [0148]). Elia’s inline functionality, which enables real-time urine flow analysis and automated data transmission, is explicitly designed to sit in the urine drainage line and continuously measure and output urine flow, thereby teaching inline flow sensors that measure fluid output and provide digital data.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, and Song in view of Elia to provide a multi-sensor array including inline flow sensors configured to measure fluid output from the hollow input tube and digitally record the flow. Both the modified Goldberg and Elia address urine drainage and monitoring in a clinical setting, with the modified Goldberg focused on sterile multi-bag collection and Elia focused on accurate, automated flow measurement and data transmission. Incorporating Elia’s known inline flow sensing module into the drainage path of the modified Goldberg’s system would represent a simple and predictable substitution of a conventional drainage line segment with a sensor-equipped segment, using standard medical tubing and connectors. The combination is technically feasible because Elia’s drip chamber and sensor are specifically designed to be placed in series with a urine drainage line, and the modified Goldberg’s catheter–manifold connection is a conventional tubing path. The benefit of this modification is to provide automated, real-time fluid output tracking within the modified Goldberg’s existing drainage architecture, reducing manual measurement errors and giving clinicians continuous visibility into urine output trends to support better patient management.
Also regarding claim 28, the modified Goldberg does not teach that the system includes: color detection sensors positioned along the input tube configured to detect color changes and blood detection through reduced light transmission using photovoltaic cells and light sources. Rather, the modified Goldberg does not teach sensors along the input tube configured to detect urine color changes, blood presence, or transparency using optical components. The modified Goldberg’s system collects fluid in translucent bags that may be visually inspected, but there is no disclosure of automated color or turbidity sensing or any optical sensor arrangement (Goldberg, FIG. 1–4; col. 3; col. 5–6).
Mantinband, however, discloses an inline urine analysis system equipped with an image capture unit and optical assembly for real-time measurement of urine properties, including color and clarity/turbidity (Mantinband, [0021], [0081]). Mantinband further discloses that the system transmits urine analysis data, including color and transparency measurements, to a remote receiver such as a phone or computer, allowing real-time tracking of urine characteristics (Mantinband, [0076]). Mantinband’s optical system detects changes in transmitted light intensity through the urine stream, which corresponds to using a light source and light-sensitive detector to monitor reduced light transmission caused by blood or other opacity-increasing components, As such, the Mantinband optical arrangement implicitly uses light sources and detection elements to sense transmitted or reflected light, which corresponds to detecting color changes and opacity consistent with the claimed blood detection via reduced light transmission through urine.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, Song, and Elia in view of Mantinband to add color detection sensors along the input tube configured to detect color changes and blood detection through reduced light transmission using photovoltaic cells and light sources. Both the modified Goldberg and Mantinband relate to urine handling and analysis; Mantinband’s optical sensor module is designed to mount inline with a urine conduit and to measure urine optical properties continuously. A skilled person would recognize that Mantinband’s inline optical sensor could be inserted along the same drainage path in the modified Goldberg’s system as Elia’s flow sensor, by adding a short housing with the optical window and light source or detector pair around a segment of tubing. The combination is feasible using standard optical sensor packaging and medical-grade tubing. The benefit of this combination is to provide automated detection of clinically significant urine color changes within the modified Goldberg’s closed drainage system, enabling early identification of bleeding or infection while maintaining sterility and reducing dependence on manual visual inspection.
Also regarding claim 28, the modified Goldberg does not teach that the system includes: electronic scale systems integrated within a base unit configured to measure weight of the at least one collection container and convert weight measurements to volume calculations using specific gravity algorithms. The modified Goldberg does not teach an electronic scale or base unit that measures the weight of the collection container, nor any conversion from weight to volume using specific gravity. Instead, the modified Goldberg suggests that the volume of fluid in the containers can be estimated from volume markings on the bags (Goldberg, col. 5–6; col. 6, ll. 19–32).
Augustine, however, teaches a urine collection system wherein the urine bag is hung from an electronic scale that measures the weight of the bag and the urine within it, and further discloses that the scale may have a digital output reported to a patient monitor, processor, or electronic record, and may transmit this data to remote devices (Augustine, [0171]–[0173]). Augustine’s system is expressly intended to monitor urine output by measuring the weight of the collection bag and using that data in digital form for clinical monitoring.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, Song, Elia, and Mantinband in view of Augustine to provide electronic scale systems integrated within a base unit configured to measure the weight of the collection containers. In the modified Goldberg, the collection bag is supported via a hook or support net; Augustine shows that a hanging collection bag can be supported on an electronic scale in the same location and that the scale output can be digitally processed and transmitted. Substituting Augustine’s electronic scale and base unit for the purely mechanical support of the modified Goldberg would be a straightforward replacement of one well-known support structure with another, while maintaining the same hanging geometry. Once the weight is measured and digitally available, converting that weight to a volume using specific gravity is a routine calculation based on the known physical relationship between mass, volume, and specific gravity for urine. Given that urine specific gravity is a well-known clinical parameter and that weight, volume, and specific gravity are related by a simple mathematical relationship, using stored specific gravity values or simple specific gravity algorithms to convert Augustine’s digitally measured weight to volume would have been a routine software implementation. A skilled person, already using Augustine’s scale output to monitor urine output, would readily appreciate that applying a specific gravity factor to convert weight to volume is a predictable algorithmic enhancement implemented in processing circuitry without requiring any structural change to the collection system. The benefit of this combination is to provide more accurate quantitative tracking of urine volume even when bags deform or are partially filled, improving measurement accuracy over simple visual estimation and enabling automated trending and alarm functions.
Also regarding claim 28, the modified Goldberg does not teach that the system includes: wireless data transmission components configured to transmit the measured flow data, color data, and weight data via wireless connections, local area network connections, wireless network connections, and internet connectivity to remote healthcare monitoring devices including smartphones, tablets, desktop computers, and medical facility monitoring stations. The modified Goldberg’s monitoring is purely manual, by reading bag volume marks and visually inspecting bags (Goldberg, col. 3; col. 5–6).
Elia discloses a urine monitoring system that defines a tolerance range for urine output and generates an alert when the measured output falls outside this range, and further discloses that the system transmits alerts and flow data to a smartphone or other computing interface for bedside or remote monitoring and has wireless capabilities (Elia, [0097], [0148]). Mantinband discloses that its inline urine analysis system transmits urine analysis data, including color and transparency measurements, to remote devices for clinical use (Mantinband, [0076]). Both Elia and Mantinband thus teach wireless or networked transmission of urine-related sensor data to smartphones, computers, or clinical monitoring systems.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, Song, Elia, Mantinband, and Augustine in view of Elia and Mantinband to include wireless data transmission components configured to transmit measured flow data, color data, and weight data to remote healthcare monitoring devices. Elia expressly transmits urine flow data and alerts to smartphones and clinical interfaces, while Mantinband teaches transmission of urine color and clarity data to remote computing devices. Once the modified Goldberg is modified to include inline flow sensors, color sensors, and electronic scale systems as described above, it would be a predictable and technically straightforward enhancement to incorporate the wireless transmission modules taught by Elia and Mantinband so that all measured parameters (flow data, color data, and weight-derived volume data) could be transmitted to the same class of remote monitoring devices. The combination is feasible because the sensors of Elia and Mantinband already output electronic data suitable for wireless modules, and Augustine’s scale system also provides digital outputs compatible with the same communication pathways. The benefit of this combination is to integrate the modified Goldberg’s multi-container drainage system into a modern, automated clinical monitoring network that reduces manual charting, enables real-time alerts for abnormal measurements, and facilitates centralized patient monitoring across smartphones, tablets, desktop computers, and medical facility monitoring stations.
Also regarding claim 28, the modified Goldberg does not teach that the system includes: processing circuitry configured to analyze the transmitted data to generate automatic alerts when measured parameters fall outside predefined tolerance ranges and to create comprehensive patient monitoring records that reduce manual charting errors and enable real-time trend analysis for early detection of medical conditions. Rather, the modified Goldberg relies on manual reading of bag volumes and manual valve operation without any electronic analysis, trend tracking, or automated alarm generation (Goldberg, col. 3; col. 5–6).
Elia discloses a urine monitoring system that defines a tolerance range for urine output and generates an alert when the measured output falls outside this range, and further enables remote transmission of alerts to a mobile device or other computing interface for real-time monitoring (Elia, [0148]).
Mantinband discloses an inline urine analysis system that evaluates urine properties, including color and transparency, and identifies abnormalities based on deviations from expected values, and discusses alarms and transmission of abnormal findings for clinical review (Mantinband, [0081], [0117]).
Augustine discloses using the output of an electronic scale to provide digital data to a patient monitor or electronic record, enabling automatic logging of urine output as part of a patient-monitoring system (Augustine, [0171]–[0173]).
Taken together, these references teach processor-based systems that receive urine-related measurements, compare them to predefined thresholds, generate alerts when values are out of range, and record data electronically for ongoing patient monitoring.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, Song, Elia, Mantinband, and Augustine in view of Elia, Mantinband, and Augustine to include processing circuitry configured to analyze the transmitted flow, color, and weight-derived volume data, generate automatic alerts when measured parameters fall outside predefined tolerance ranges, and create comprehensive patient monitoring records that reduce manual charting errors and enable real-time trend analysis for early detection of medical conditions. Once the modified Goldberg is modified to incorporate the sensor and wireless transmission features taught by Elia, Mantinband, and Augustine, adding processor logic to evaluate received data against stored thresholds, issue alarms, and maintain time-stamped electronic records would be a routine software and systems integration task based on well-established clinical monitoring platforms. The benefit of this combination is to transform the modified Goldberg’s basic drainage system into an integrated clinical decision-support tool that automatically flags abnormal trends, reduces reliance on manual charting, and supports earlier detection of conditions such as acute kidney injury, dehydration, bleeding, or infection.
Regarding claim 30, the modified Goldberg does not teach that the system further comprises a base unit including an electronic scale system configured to automatically tare when collection containers are placed thereon and continuously measure weight changes with real-time conversion to fluid volume using specific gravity calculations. Rather, the modified Goldberg does not teach an electronic scale or base unit that measures the weight of the collection container, nor any conversion from weight to volume using specific gravity. Instead, the modified Goldberg suggests that the volume of fluid in the containers can be estimated from volume markings on the bags (Goldberg, col. 5–6; col. 6, ll. 19–32).
Augustine, however, teaches a urine collection system wherein the urine bag is hung from an electronic scale that measures the weight of the bag and the urine within it (including timed data and rate), and further discloses that the scale may have a digital output reported to a patient monitor, processor, or electronic record, and may transmit this data to remote devices (Augustine, [0171]–[0173], [0457]). Augustine’s system is expressly intended to monitor urine output by measuring the weight of the collection bag and using that data in digital form for clinical monitoring (Augustine, [0171]–[0173]). Additionally, the system is "programmed to record the beginning weight (e.g., establish a zero point) of the fluid suction bag" (Augustine, [0284]) and "sensing, with the sensor, when the urine bag is initially placed on the urine bag hanger; and zeroing the first weight, using the circuitry, when the sensor senses that the urine bag is initially placed on the urine bag hanger to establish a start point for measuring the collection of urine" (Augustine, [0498]), demonstrating the ability to automatically tare when a new bag is used.
Once the weight is measured and digitally available, converting that weight to a volume using specific gravity is a routine calculation based on the known physical relationship between mass, volume, and specific gravity for urine. Given that urine specific gravity is a well-known clinical parameter and that weight, volume, and specific gravity are related by a simple mathematical relationship, using stored specific gravity values or simple specific gravity algorithms to convert Augustine’s digitally measured weight to volume would have been a routine software implementation, requiring only the addition of straightforward calculation logic to the processing circuitry already contemplated by Augustine for reporting weight-based urine output data to a patient monitor or electronic record (Augustine, [0171]–[0173]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, and Song in view of Augustine to provide a base unit including an electronic scale system, capable of automatically taring a new bag, that continuously measures the weight of the collection container and converts those weight measurements to fluid volume using specific gravity calculations. The combination is possible because Goldberg’s collection bags are already suspended from a support structure, and Augustine shows that the same type of hanging collection bag can be supported on an electronic scale with digital output instead of a simple hook. Substituting Augustine’s electronic scale and base unit for the purely mechanical support of the modified Goldberg would be a straightforward replacement of one well-known support structure with another, while maintaining the same hanging geometry. Once Augustine’s scale system is integrated, adding specific-gravity-based conversion logic to derive real-time volume from measured weight requires only routine software implementation based on well-known physical relationships, with no change to the fluid-handling hardware. The benefit of this combination is to provide more accurate quantitative tracking of urine volume even when bags deform or are partially filled, improving measurement accuracy over simple visual estimation and enabling automated trending and alarm functions and also to eliminate manual taring steps, reduce user error, and ensure that measured weight changes accurately reflect only the collected fluid, thereby supporting precise real-time volume calculations.
Also regarding claim 30, the modified Goldberg do not teach that the base unit further includes wireless data transmission capabilities configured to transmit weight data, volume calculations, and fluid collection trends to remote receivers. The modified Goldberg’s monitoring discloses digital output and reporting time/weight/volume/rate data to patient monitors or remote electronic records but does not explicitly describe wireless transmission to a range of remote devices (Augustine, [0171]–[0173]; [0457]).
Elia discloses a urine monitoring system that defines a tolerance range for urine output and generates an alert when the measured output falls outside this range, and further discloses that the system transmits alerts and flow data to a smartphone or other computing interface for bedside or remote monitoring and has wireless capabilities (Elia, [0097], [0148]).
Mantinband discloses that its inline urine analysis system transmits urine analysis data, including color and transparency measurements, to remote devices for clinical use (Mantinband, [0076]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, Song, and Augustine in view of Elia and Mantinband to include wireless data transmission capabilities in the base unit configured to transmit weight data, volume calculations, and fluid collection trends to remote receivers. Once Augustine’s electronic scale and base unit are used to generate digital weight-based urine output data and specific-gravity-derived volume calculations, adding Elia- or Mantinband-type wireless or networked transmission modules represents a straightforward integration of known communication hardware and protocols into an already electronic monitoring system. The combination is feasible because Augustine’s scale system outputs digital data suitable for input to wireless transmitters or network interfaces of the kind expressly used in Elia and Mantinband, and routing the same processed weight and volume data to smartphones, tablets, desktop computers, or medical facility monitoring stations involves only standard interfacing and software configuration. The benefit of this combination is to integrate the modified Goldberg’s multi-container drainage system into a modern, automated clinical monitoring network that reduces manual charting, enables real-time visualization of fluid collection trends, and allows remote caregivers to monitor urine output without being physically present at the bedside.
Also regarding claim 30, the modified Goldberg does not fully teach that . Rather, the modified Goldberg discloses using the output of an electronic scale to provide digital data to a patient monitor or electronic record, but does not expressly describe preset weight thresholds for full containers, automatic alert generation, or time-stamped trend logging (Augustine, [0171]–[0173]).
Elia discloses a urine monitoring system that defines a tolerance range for urine output and generates an alert when the measured output falls outside this range, and further enables remote transmission of alerts to a mobile device or other computing interface for real-time monitoring (Elia, [0148]).
Mantinband discloses an inline urine analysis system that evaluates urine properties, including color and transparency, and identifies abnormalities based on deviations from expected values, and discusses alarms and transmission of abnormal findings for clinical review (Mantinband, [0081], [0117]).
Augustine discloses using the output of an electronic scale to provide timed digital data to a patient monitor or electronic record, enabling automatic logging of urine output as part of a patient-monitoring system (Augustine, [0171]–[0173], [0498]). Additionally, Augustine expressly contemplates sensing and notifications when fluid-receiving vessels become full. Augustine discloses that "one or more fluid level sensors 153 may automatically activate or deactivate the vacuum valves to a given canister, thereby automatically shifting the blood and fluid flow to a new canister as the previous one is filled" and further that "the surgical nurse can be wirelessly notified on their portable monitor, that one or more canisters are full of blood and fluid" (Augustine, ¶[0280]). This demonstrates Augustine’s recognition of the usefulness of automated full-container detection and wireless notifications, even though provided in a suction-canister context, and therefore reinforces the motivation for incorporating similar full-container alerting into a urine-collection scale system.
Taken together, these references teach processor-based systems that receive timed urine-related measurements, compare them to predefined thresholds, generate alerts when values are out of range, and record data electronically for ongoing patient monitoring.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, Song, Augustine, Elia, and Mantinband in view of Augustine, Elia, and Mantinband to include processing circuitry in the base unit configured to analyze the transmitted weight and volume data, generate automatic alerts when measured values exceed preset weight thresholds corresponding to full collection containers, and maintain timestamped electronic records of these measurements for comprehensive patient monitoring. Once Augustine’s scale and digital reporting features are combined with the threshold-based alerting and remote notification capabilities of Elia and Mantinband, implementing software logic that compares accumulated weight or volume values against stored threshold values for “full” bag conditions, issues alerts when those thresholds are reached, and logs each measurement and alert with a timestamp in an electronic record would have been a routine application of known patient-monitoring techniques. The benefit of this combination is to transform the modified Goldberg’s basic drainage system into an integrated clinical decision-support tool that automatically flags when bags are full, reduces reliance on manual checking and charting, and enables remote staff to monitor urine collection status and trends without constant bedside presence, thereby improving workflow efficiency and patient safety.
Claims 29 is rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Song et al. (CN208726362U), hereto referred as Song, and further in view of Tomisaka et al. (US 5540661 A), hereto referred as Tomisaka, and further in view of Købke (US 20190231582 A1), hereto referred as Købke, and further in view of Russo et al. (US 20030195478 A1), hereto referred as Russo.
The modified Goldberg teaches claim 21 as described above.
Regarding claim 29, the modified Goldberg does not teach that the first and second valves are constructed with external hard polymer portions and internal soft elastomer inserts made of silicone, and are configured to be swab-able and easily wiped down with alcohol between bag changes to reduce contamination risk in healthcare environments. The modified Goldberg demonstrates controllable drainage valves and closed fluid pathways, as shown above in claim 21, but does not disclose (1) constructing the valves using external hard polymer portions and internal silicone elastomer inserts or (2) configuring the valve surfaces to be swab-able and easily wiped down with alcohol between bag changes.
Tomisaka discloses a medical valve assembly comprising a rigid plastic housing and an internal elastomeric silicone valve component. Tomisaka states that “Device 10… includes a plastic housing 12… [of] polycarbonate, Dow Isoplast, rigid PVC, or Ektar”, demonstrating a hard-polymer external structure. Tomisaka further teaches that “An elastomeric (e.g., silicone or polyisoprene rubber) valve 16… is associated with housing 12,” showing an internal silicone-based elastomer insert (Tomisaka, col. 2, ll. 40-57). Tomisaka also explicitly describes alcohol-wipe resistance and intended cleaning, explaining that “both web 18 and coating 22 should be resistant to breakdown or chemical attack by cleaning solutions, including disinfectants such as alcohol” (Tomisaka, col. 2-3, ll. 58-3) and that “the coated web surface was wiped with isopropyl alcohol between each reuse to simulate a typical cleaning operation in practice" (Tomisaka, col. 4, ll. 44-50). These disclosures collectively fill the missing claim requirements of (1) hard-polymer valve housing, (2) silicone elastomer insert, and (3) surfaces designed for repeated alcohol wiping to reduce contamination risk.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, and Song in view of Tomisaka to construct the first and second valves with hard-polymer outer housings, silicone-based internal elastomer components, and surfaces that can be repeatedly cleaned with alcohol between bag uses. Because both systems concern medical fluid-handling valves that must maintain sterility and withstand repeated cleaning, one of ordinary skill in the art would have recognized that applying Tomisaka’s known material pairings and alcohol-compatible surface treatments to the valves of the modified Goldberg system is a predictable, routine design choice. Such modification would yield well-recognized benefits including improved sealing, enhanced chemical resistance, increased hygiene due to alcohol-wipe compatibility, and reduced contamination risk during bag changes, motivating one of ordinary skill in the art to adopt this configuration in the combined system.
Also regarding claim 29, the modified Goldberg does not teach that the at least one collection container contains hydrogel configured to absorb fluid and convert it to gel form. The modified Goldberg system includes a collection container but does not disclose incorporating a hydrogel (defined as a “super absorbent polymer” among other things, Instant Application, [0024]) capable of absorbing fluid and converting it to a gel.
Købke teaches the use of absorbent materials within urine-collection receptacles. Købke states that “The receptacle compartment 28 comprises a fluid absorbent powder 30 for stabilizing urine” (Købke ¶[0078]), showing inclusion of an absorbent medium. Købke further discloses absorbent and super-absorbent polymers that, upon absorbing urine, form a gel-like mass within the receptacle (Købke ¶[0026]–[0029]). These passages demonstrate that Købke explicitly contemplates placing absorbent materials inside a receptacle so that incoming urine is absorbed and transformed into a stabilized hydrogel. This directly corresponds to a hydrogel configured to absorb fluid and convert it to gel form, filling the missing limitation in the modified Goldberg system.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, Song, and Tomisaka in view of Købke to include an absorbent medium such as a hydrogel within the collection container to absorb fluid and convert it to gel form. Given that both systems relate to urine or bodily-fluid collection, one of ordinary skill in the art would have recognized that incorporating known absorbent media improves containment, reduces spillage, and enhances hygiene. The modification would provide recognized benefits including stabilized fluid, reduced leakage, and improved safety during handling and disposal, motivating one of ordinary skill in the art to incorporate such absorbent materials in the combined system.
Also regarding claim 29, the modified Goldberg does not teach that the system further comprising automatic safety mechanisms wherein removal of the collection container immediately cuts off fluid flow by the connected valve entering into a fluid-closed state. The modified Goldberg provides detachable collection containers but does not disclose any automatic closure mechanism that activates when the container is removed.
Song teaches an automatic safety closure that activates when a urine bag is removed. Song explains that when the connecting sleeve and urine bag are separated from the fixed sleeve, the valve structure in the fixed sleeve automatically closes the end of the drainage tube that is away from the user, placing it in a sealed state (Song, FIG. 2, ¶[0014]). Song explains that this automatic closure prevents outside air from entering the patient’s urethra and thereby prevents bacterial cross-infection. Song further discloses that a second one-way valve on the bag side automatically closes upon separation to prevent odor and thus urine from escaping into the environment (Song, FIG. 2, ¶[0014]). Together, these features provide an automatic safety mechanism that closes both sides of the flow path immediately upon bag removal. Similarly a person of ordinary skill in the art would understand that the reverse would be true, where connecting the fixed sleeve to the connecting sleeve would open the slots/valves.
Russo similarly teaches an automatic connector-actuated valve that has a steady state in the flow-off position and is automatically moved to a flow-on state by insertion of a mating connector, and returns to the flow-off state when the connector is removed (Russo, [0061]–[0063]). Russo’s valve assembly is biased closed and opens only when a connector (e.g., a male luer) is inserted into the valve body, then automatically closes again when that connector is removed (Russo, [0061]–[0063]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, Song, Tomisaka, and Købke in view of Song and/or Russo to implement an automatic safety mechanism in which removal of the collection container causes the connected valve to immediately enter a fluid-closed state. The modified Goldberg already provides removable connectors and valves in a closed fluid path for bodily-fluid collection, while Song and Russo teach that connector-based medical drainage and transfer systems can employ valves that are biased to a flow-off state and automatically open when a connector is attached and close when the connector is removed. It would be technically straightforward for one of ordinary skill in the art to incorporate a Song- or Russo-type biased valve into the removable connector interface of the modified Goldberg system so that disconnecting the collection container mechanically releases the bias and returns the valve to its normally closed, no-flow state. The benefit of this combination is to enhance sterility and safety during bag changes by eliminating the need for manual valve operation, preventing leakage and spillage, blocking backflow and air ingress to the patient, and reducing contamination of the surrounding environment, thereby advancing the goals already recognized in Goldberg’s closed, sterile collection system.
Claim 31 is rejected under 35 U.S.C. 103 as obvious over Goldberg et al. (US 4435171 A), hereto referred as Goldberg, and further in view of Flinchbaugh et al. (US 20020143318 A1), hereto referred as Flinchbaugh, and further in view of Tomisaka et al. (US 5540661 A), hereto referred as Tomisaka, and further in view of Song et al. (CN208726362U), hereto referred as Song, and further in view of Russo et al. (US 20030195478 A1), hereto referred as Russo, and further in view of Købke (US 20190231582 A1), hereto referred as Købke, and further in view of Elia et al. (US 20200253530 A1), hereto referred as Elia, and further in view of Mantinband et al. (US 20170367636 A1), hereto referred as Mantinband, and further in view of Augustine et al. (US 20200281790 A1), hereto referred as Augustine, and further in view of Wolff et al. (US 20020087131 A1), hereto referred as Wolff.
Regarding claim 31, Goldberg teaches that a fluid monitoring and collection system (Goldberg, FIG. 1, 4; col. 3, Il. 3-16: "drainage device is coupled to a subject so that fluid flows from the patient into the manifold... to direct the fluid into one of the containers, and fluid is allowed to collect in this container", demonstrating a bodily fluid collection system; col. 9, ll. 49-60: "provided with a volumetric scale 222 by means of which the volume of fluid contained in the container may be estimated", disclosing that the fluid volume is monitored as part of the system) comprises: a hollow input tube (Goldberg, FIG. 1; col. 2-3, Il. 59-2: "the manifold may be connected to a drainage catheter which is conventionally located to drain urine from the bladder of a human subject", where the catheter 62 is a hollow tube used as an input tube from the bladder to the manifold) having: an inlet configured to receive fluid from a fluid source (Goldberg, FIG. 1; col. 2-3, ll. 59-2: "a drainage catheter which is conventionally located to drain urine from the bladder of a human subject", demonstrating the tube receiving fluid from a fluid source, where a catheter implicitly has an inlet); and a tube output configured to output the received fluid (Goldberg, FIG. 1: depicts the catheter with an output connected to port 50 of the manifold, to output the fluid into the manifold); a sequential valve assembly (Goldberg, FIG. 1, where the combination of the manifold 10 and the valved output ports 30 with valves 40 makes up the valve assemble and the figure depicts the ports/valves sequentially aligned along the length of the assembly) comprising: an input tube configured to receive fluid from the tube output of the hollow input tube (Goldberg, FIG. 1; col. 2-3, IL. 59-2: "The drainage device of this invention includes a central manifold adapted for connection to a source of body fluid..."; col. 5, Il. 25-43: "This drainage manifold 10 is a generally tubular structure which is provided with a valved input port 50 and four valved output ports 30"; col. 5, II. 44-51: "input port 50 is adapted for connection to a catheter 62 which is in turn coupled to a source of body fluid"; where the tubular manifold acts as the input tube receiving fluid from the drainage catheter via port 50); the input tube defining a primary flow channel extending linearly from a first terminal end to a second terminal end (See annotated figure below; Goldberg, FIG. 1; col. 2-3, Il. 59-2; col. 5, Il. 25-43: Goldberg describes the drainage manifold 10 as a generally tubular structure which is adapted for connection to a catheter 62 and which distributes body fluid to a plurality of valved output ports 30. The interior of manifold 10 defines a linear continuous flow passage extending between opposite terminal ends of the tube, so that urine entering through input port 50 flows along this primary flow channel and past the output ports 30 to whichever ports are opened. Under a broadest reasonable interpretation, the tubular interior of manifold 10 constitutes the claimed primary flow channel extending from a first terminal end of the tube to an opposite second terminal end. Thus, this element is anticipated by Goldberg. Although, to the extent a more restrictive interpretation is applied requiring a manifold having only two valved output locations at or near the respective terminal ends, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to omit unused intermediate ports and employ only those ports necessary for connection to two collection containers, consistent with routine design considerations for simplifying fluid routing and reducing component use. Furthermore, Goldberg's manifold does not require that every intermediate port or associated valve be used in any given clinical configuration. As shown in figure 1, Goldberg explicitly depicts only a single drainage bag deployed to the manifold while the remaining output ports, valve structures, and bags remain unused, yet the system continues to function as intended (Goldberg, FIG. 1). The figure therefore demonstrates that the unused intermediate ports perform no required function when fluid is being directed to only one (or only two) collection containers and that the manifold is fully operative even when most ports are not fluidly connected to bags. Under MPEP § 2144.04, omission of an element is an obvious modification where the omitted element does not perform a function necessary to the combination. Here, because Goldberg's unused intermediate ports are optional and contribute no necessary function in a two-container configuration, it would have been an obvious design choice to omit the unused ports and retain only those ports needed to connect two containers while preserving the same continuous tubular flow path extending between the manifold’s terminal ends. The benefit would be simplifying the device and reducing manufacturing cost by reducing the number of valves and port structures while preserving the same flow control functionality. (See MPEP: 2144.04: Omission of an Element and Its Function Is Obvious if the Function of the Element Is Not Desired and/or Omission of an Element with Retention of the Element's Function Is an Indicium of Nonobviousness)); a first valve in fluid communication with the input tube at a first position along the primary flow channel proximate to a first terminal end (Goldberg, FIG. 1; col. 5, Il. 25-43, 60-66: manifold 10 is a tubular member with multiple valved output ports 30 spaced along its length, each port including a valve 40 that opens into the interior of the manifold; at least one of these valved ports 30 is positioned nearest one terminal end of manifold 10 and thus lies at a first position along the primary flow channel proximate to that terminal end) and having: a valve output (Goldberg, FIG. 1; col. 3, Il. 3-16: "The valves are positioned to direct the fluid into one of the containers..."; showing that the valves implicitly have an output as they are connected to containers 20 which collect the fluid that comes out of the valves); and a flow control mechanism configured to regulate fluid flow between the valve input and valve output (Goldberg, FIG. 1, col. 5, Il. 60-66: "Each of the valved output ports 30 includes a valve 40 which operates to selectively seal the port 30", showing that valve 40 (i.e. fluid control mechanism) regulates the fluid flow between the input and output of the valved output port 30); a second valve in fluid communication with the input tube positioned at a second position along the primary flow channel, the second position being further downstream from said first position and proximate to a second terminal end (See annotated figure below; Goldberg, FIG. 1; col. 5, Il. 25-43, 60-66: Goldberg's manifold 10 includes additional valved output ports 30 spaced farther along the tubular interior away from the first terminal end and nearer the opposite terminal end; the furthest-used port 30 and its valve 40 are therefore located at a second position farther along the same primary flow channel from the first valve and proximate to the opposite terminal end of the manifold) and having: a valve output (Goldberg, FIG. 1; col. 3, Il. 3-16: "The valves are positioned to direct the fluid into one of the containers..."; showing that the valves implicitly have an output as they are connected to containers 20 which collect the fluid that comes out of the valves); and a flow control mechanism configured to regulate fluid flow between the valve input and valve output (Goldberg, FIG. 1, col. 5, ll. 60-66: "Each of the valved output ports 30 includes a valve 40 which operates to selectively seal the port 30", showing that valve 40 (i.e. fluid control mechanism) regulates the fluid flow between the input and output of the valved output port 30); wherein the first and second valves are configured to independently control fluid flow through the respective valve outputs (Goldberg, FIG. 1; col. 3, ll. 3-16: "...the associated valve is then closed in order to isolate this fluid filled container from the manifold, and the associated conduit is severed... another valve is opened to allow fluid to collect in another container"; Although Goldberg describes a preferred use in which one valve is opened at a time, each valve 40 is structurally configured for independent actuation, with no mechanical dependence between them. Thus, they are configured to independently control fluid flow through their respective valve outputs); at least one collection container comprising: a fluid bag defining a water-tight interior (Goldberg, col. 5, Il. 25-43: "containers 20 are shown collapsed and folded for storage into small packets and one of the containers 20a is shown unfolded, ready to receive fluid from the manifold 10. Preferably, each container is formed of a flexible, plastic material such as vinyl, polyethelene, or some other suitable material", where the containers are described as col. 6-7, Il. 54-7 "two-liter bags"; demonstrating multiple collection containers, made from such materials to create a water-tight fluid bag) and a removable connector having: an input configured to removably connect to one of the valve outputs (Goldberg, col. 5-6, Il. 61-18: "Each container 20 includes a narrow neck region 24 which is sealed to one of the input ports 30", col. 3, ll. 3-30: "The fluid filled container is then removed for testing or disposal", where the neck region 24 functions as the claimed connector, having an input end that attaches to the valve output (i.e., port 30) and an output end fixed to the fluid bag; Although the term "sealed" implies a semi-permanent connection, Goldberg explicitly states that the container is removed from the manifold for testing or disposal, indicating that the connection is removably connected to the valve); and an output fixed to the fluid bag and defining a lumen fluidically connected to the interior of the fluid bag (Goldberg, col. 5-6, Il. 61-18: "Each container 20 includes a narrow neck region 24 which is sealed to one of the input ports 30"; the output of neck region 24 is fixed to the fluid bag and defines an internal passageway (i.e. lumen) fluidically connected to the bag's interior).
Also regarding claim 31, Goldberg does not teach that a user-adjustable therapeutic pressure control valve is fluidically connected to the inlet, having a user-selectable pressure flow setting configured to be adjusted by healthcare providers, and being configured to permit flow of the fluid into the inlet only when the fluid is at a pressure above the user-selectable pressure flow setting. Goldberg teaches that the input port 50 "includes a valve 60 which operates to selectively seal the port 50" (Goldberg, col. 5, ll. 52-56, see also FIG. 4), so that valve 60 is fluidically connected between catheter 62 (the inlet from the bladder) and the manifold 10. However, Goldberg does not teach that the valve is therapeutic, user-adjustable, or configured such that a healthcare provider selects the precise pressure threshold above which flow is permitted. Goldberg does not disclose clinical adjustment or a user-selectable flow threshold.
Flinchbaugh teaches a clinician-adjustable therapeutic pressure regulator in a medical fluid drainage system. Flinchbaugh explicitly discloses that “manual external rotational adjustment of externally adjustable screw 30 controls the… valve pressure opening adjustment, or variable pressure setting” (Flinchbaugh, col. 6-7, ll. 59-24; see also Abstract). Flinchbaugh further teaches that the clinician may “press[] the button inwardly and slid[e] the magnetic base member… [to] decrease… the head pressure to open the valve” (Flinchbaugh, col. 7, ll. 24–33), and that the system permits “significant degree of valve pressure opening adjustment” for therapeutic bladder-management situations (Flinchbaugh, col. 6–7, ll. 59–24). These disclosures show (1) a therapeutic purpose, (2) a user-adjustable pressure setting selected by a clinician, and (3) a gating function in which fluid communication occurs only when the opening pressure exceeds the selected threshold.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Goldberg in view of Flinchbaugh to provide a user-adjustable therapeutic pressure control valve with a clinician-selected pressure threshold permitting flow only when the line pressure exceeds the preset value. Both Goldberg and Flinchbaugh concern medical fluid-handling systems requiring controlled flow and pressure regulation, and Flinchbaugh provides a known, clinically adjustable regulator designed for therapeutic pressure control. Incorporating Flinchbaugh’s clinician-adjustable pressure settings into Goldberg’s drainage valve would have been a predictable substitution of one known pressure-control approach for another, yielding recognized benefits including improved clinical control, safer drainage, and the ability to tailor flow thresholds to patient-specific therapeutic requirements, thereby motivating one of ordinary skill in the art to adopt such a modification in the combined system.
Also regarding claim 31, the modified Goldberg does not teach that the first valve is constructed with an external hard polymer portion and internal soft elastomer insert made of silicone and is configured to be swab-able and easily wiped down with alcohol between bag changes to reduce contamination risk in healthcare environments, and that the second valve is constructed with an external hard polymer portion and internal soft elastomer insert made of silicone and is configured to be swab-able and easily wiped down with alcohol between bag changes. The modified Goldberg teaches first and second valves placed along the flow path to selectively direct urine from the bladder to either collection container (Goldberg, FIG. 2; col. 4, ll. 19–27; col. 5, ll. 35–43). However, it does not teach that these valves include (1) an external hard polymer housing, (2) an internal silicone-based elastomeric insert, or (3) surfaces designed to withstand repeated alcohol wiping for contamination control.
Tomisaka discloses a medical valve assembly comprising a rigid plastic housing and an internal elastomeric silicone valve component. Tomisaka states that “Device 10… includes a plastic housing 12… [of] polycarbonate, Dow Isoplast, rigid PVC, or Ektar”, demonstrating a hard-polymer external structure. Tomisaka further teaches that “An elastomeric (e.g., silicone or polyisoprene rubber) valve 16… is associated with housing 12,” showing an internal silicone-based elastomer insert (Tomisaka, col. 2, ll. 40-57). Tomisaka also explicitly describes alcohol-wipe resistance and intended cleaning, explaining that “both web 18 and coating 22 should be resistant to breakdown or chemical attack by cleaning solutions, including disinfectants such as alcohol” (Tomisaka, col. 2-3, ll. 58-3) and that “the coated web surface was wiped with isopropyl alcohol between each reuse to simulate a typical cleaning operation in practice" (Tomisaka, col. 4, ll. 44-50). These disclosures collectively fill the missing claim requirements of (1) hard-polymer valve housing, (2) silicone elastomer insert, and (3) surfaces designed for repeated alcohol wiping to reduce contamination risk.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg and Flinchbaugh in view of Tomisaka to construct the first and second valves with hard-polymer outer housings, silicone-based internal elastomer components, and surfaces that can be repeatedly cleaned with alcohol between bag uses. Because both systems concern medical fluid-handling valves that must maintain sterility and withstand repeated cleaning, one of ordinary skill in the art would have recognized that applying Tomisaka’s known material pairings and alcohol-compatible surface treatments to the valves of the modified Goldberg system is a predictable, routine design choice. Such modification would yield well-recognized benefits including improved sealing, enhanced chemical resistance, increased hygiene due to alcohol-wipe compatibility, and reduced contamination risk during bag changes, motivating one of ordinary skill in the art to adopt this configuration in the combined system.
Also regarding claim 31, the modified Goldberg does not teach that the removal of a connected collection container immediately cuts off fluid flow by the connected valve entering into a fluid-closed state; a one-way container valve integrated into the removable connector and configured to prevent backflow out of the removable connector while automatically sealing the collection container upon removal. The modified Goldberg system teaches removable collection containers and valves positioned to direct urine, but it does not teach a connector-integrated one-way valve that automatically seals the collection container upon removal to prevent backflow, leakage, or odor release. In the modified Goldberg system, removal of the bag does not inherently trigger closure of either the bag side or the system side of the flow path.
Song teaches that when the connecting sleeve and urine bag are separated from the fixed sleeve, the drainage-tube end “is in a closed state” (Song, FIG. 2, ¶[0014]), preventing outside air from entering the pathway which also indicates fluid cannot come out. Song further teaches that the bag itself is automatically sealed by a “second one-way valve… preventing the odor of urine in the urine bag from being discharged… when the connecting sleeve together with the urine bag is separated” (Song, ¶[0014]). Where the one-way indicates backflow prevention and the closed state is created by the bag removal. Together, Song’s one-way valves seal both sides of the interface immediately upon removal of the bag, preventing leakage, backflow, and environmental contamination.
Russo likewise teaches a connector-actuated medical valve that is “biased to the closed position,” opens only when a mating connector is inserted, and “automatically returns to its normally closed position” when the connector is removed (Russo, ¶[0061]–[0063]). Russo therefore confirms that medical connectors commonly incorporate automatic sealing structures that transition to the closed state in response to disconnection.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, Tomisaka, Song, and Russo in view of Song and/or Russo to provide a valve that cuts off fluid flow upon bag removal and a one-way valve that automatically seals the collection container upon removal. The modified Goldberg already includes removable connectors for fluid transfer, and Song and Russo teach that such connectors may include biased, normally-closed valve structures that automatically seal both the patient-side tube and the bag-side container upon disconnection. Incorporating these known one-way, biased-closure valves into the removable connector of the modified Goldberg system would require only substituting the connector geometry and valve biasing mechanisms already shown in Song and Russo. The benefit of this modification is improved safety, prevention of spills or backflow, elimination of air ingress, and reduced contamination risk during bag replacement, furthering the clinical goals of the combined system.
Also regarding claim 31, the modified Goldberg does not teach that the collection container contains hydrogel configured to absorb fluid and convert it to gel form. The modified Goldberg system teaches urine collection using flexible bags but does not teach including an absorbent medium, such as a hydrogel (defined as a "super absorbent polymer" among other things, Instant Application, [0024]), inside the collection container to absorb fluid and convert it to gel form. The modified Goldberg system relies on gravity drainage and storage of liquid urine, not gel-conversion technology.
Købke teaches the use of absorbent materials within urine-collection receptacles. Købke states that “The receptacle compartment 28 comprises a fluid absorbent powder 30 for stabilizing urine” (Købke ¶[0078]), showing inclusion of an absorbent medium. Købke further discloses absorbent and "super absorbent polymers" that, upon absorbing urine, form a gel-like mass within the receptacle (Købke ¶[0026]–[0029]). These passages demonstrate that Købke explicitly contemplates placing absorbent materials inside a receptacle so that incoming urine is absorbed and transformed into a stabilized hydrogel. This directly corresponds to a hydrogel configured to absorb fluid and convert it to gel form, filling the missing limitation in the modified Goldberg system.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, Tomisaka, Song, and Russo in view of Købke to include hydrogel, such as super absorbent polymer, within the collection container to absorb urine and convert it to gel form. The modified Goldberg system already uses removable collection bags for urine management, and Købke demonstrates that adding a superabsorbent polymer to such a container is a known and straightforward way to immobilize the collected fluid. Integrating a Købke-type hydrogel into the existing removable bags of the combined Goldberg system would require only the addition of an absorbent material and would not alter the basic collection or valve operation. The benefit of this modification is improved containment, reduced risk of spillage during transport or disposal, enhanced hygiene, and greater safety for healthcare personnel handling the bags, thereby advancing the clinical goals already recognized in the combined system.
Also regarding claim 31, the modified Goldberg does not teach that the system comprises a comprehensive multi-sensor healthcare monitoring array including inline flow sensors configured to measure fluid output from the hollow input tube and digitally record the flow, color detection sensors positioned along the input tube configured to detect color changes and blood detection through reduced light transmission using photovoltaic cells and light sources, electronic scale systems integrated within a base unit configured to measure weight of the at least one collection container and convert weight measurements to volume calculations using specific gravity algorithms, and wireless data transmission components configured to transmit the measured flow data, color data, and weight data to remote healthcare monitoring devices including smartphones, tablets, desktop computers, and medical facility monitoring stations. The modified Goldberg system is limited to manual observation of bag volume using scale markings and does not provide any digital sensing of flow rate, urine color or blood content, container weight, or remote communication of these measurements. In contrast, Elia provides sensor-based digital flow measurement in a urine monitoring system, Mantinband provides inline optical urine-color and blood-detection sensing, and Augustine provides electronic scale-based measurement of urine bag weight with digital output and transmission of urine-output data, including the ability to send such data to remote devices. Taken together, these references teach sensor arrays applied to urine drainage lines and collection containers to measure flow, optical properties, weight, and to communicate those measurements electronically for clinical monitoring.
Elia discloses a urine analysis device that detects urine flow using a drip chamber and sensor, providing real-time volume measurement and transmission of the data for bedside monitoring (Elia, FIG. 4 and [0097]) and will even transmit alerts about flow data to a smartphone via wireless transmission (Elia, [0148], [0097]). Elia’s inline functionality, which enables real-time urine flow analysis and automated data transmission, is explicitly designed to sit in the urine drainage line and continuously measure and output urine flow, thereby teaching inline flow sensors that measure fluid output and provide digital data.
Mantinband discloses an inline urine analysis system equipped with an image capture unit and optical assembly for real-time measurement of urine properties, including color and clarity/turbidity (Mantinband, [0021], [0081]). Mantinband further discloses that the system transmits urine analysis data with wireless communications to remote devices (Mantinband, [0073]-[0076]: “such as a tablet computer or cell phone or any external system”, “update a health service provider"), including color and transparency measurements, to a remote receiver such as a phone or computer, allowing real-time tracking of urine characteristics (Mantinband, [0076], [0066]). Mantinband’s optical system detects changes in transmitted light intensity through the urine stream, which corresponds to using a light source and light-sensitive detector to monitor reduced light transmission caused by blood or other opacity-increasing components, As such, the Mantinband optical arrangement implicitly uses light sources and detection elements to sense transmitted or reflected light, which corresponds to detecting color changes and opacity consistent with the claimed blood detection via reduced light transmission through urine.
Augustine, however, teaches a urine collection system wherein the urine bag is hung from an electronic scale that measures the weight of the bag and the urine within it, and further discloses that the scale may have a digital output reported to a patient monitor, processor, or electronic record, and may transmit this data to remote devices (Augustine, [0171]–[0173]). Augustine’s system is expressly intended to monitor urine output by measuring the weight of the collection bag and using that data in digital form for clinical monitoring.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, Tomisaka, Song, Russo, and Købke in view of Elia, Mantinband, and Augustine to provide a comprehensive multi-sensor healthcare monitoring array including inline flow sensors, color-detection sensors, electronic scale systems for weight-to-volume conversion using specific gravity, and wireless data transmission components as claimed. The combined Goldberg system already drains urine into removable bags in a hospital environment and provides a context in which more detailed monitoring of urine production and properties is clinically useful, while Elia, Mantinband, and Augustine show that flow, color/blood, and weight data can be sensed electronically in urine systems and transmitted to local or remote monitors. Incorporating flow sensors as in Elia, optical color/blood sensors as in Mantinband, and Augustine’s electronic scale and communication features into the existing Goldberg collection bags and tubing would have been a straightforward integration of known sensor modules into known fluid-collection hardware, using conventional electronic interfaces and network connections. Once the weight is measured and digitally available, converting that weight to a volume using specific gravity is a routine calculation based on the known physical relationship between mass, volume, and specific gravity for urine. Given that urine specific gravity is a well-known clinical parameter and that weight, volume, and specific gravity are related by a simple mathematical relationship, using stored specific gravity values or simple specific gravity algorithms to convert Augustine’s digitally measured weight to volume would have been a routine software implementation. The benefit of this combination is to automate fluid-output monitoring, reduce manual charting and visual inspection, enable real-time trend analysis of urine output and composition, and allow remote caregivers to track patient status from smartphones, tablets, desktop computers, or central monitoring stations, thereby enhancing clinical decision-making and early detection of adverse conditions.
Also regarding claim 31, the modified Goldberg does not explicitly teach that the system comprises processing circuitry configured to analyze the transmitted flow, color, and weight data to generate automatic alerts when measured parameters fall outside predefined tolerance ranges, to create comprehensive patient monitoring records that reduce manual charting errors and enable real-time trend analysis for early detection of medical conditions. Rather, he modified Goldberg system does not explicitly provide processing circuitry configured to analyze transmitted flow, color, and weight data, compare those measurements to predefined tolerance ranges, generate automatic alerts when measured values are out of range, maintain comprehensive, timestamped patient-monitoring records, enable real-time trend analysis for early detection of medical conditions, or automatically redirect flow from a full first collection container to a second container.
Augustine teaches processor-based handling of weight and level data in a urine or fluid collection context. Augustine discloses digital acquisition of bag-weight data and transmission of that data to patient monitors and electronic records (Augustine, [0171]–[0173], [0457]), together with circuitry that records a baseline weight, zeroes the scale when a new bag is attached, and uses that baseline as a starting point for accumulating urine collection measurements (Augustine, [0284], [0498]).
Elia discloses defining tolerance ranges for urine-output parameters and using processing circuitry to generate alerts when the measured flow values fall outside those ranges, with alerts transmitted to mobile devices or other computing interfaces for real-time monitoring (Elia, [0097], [0148]).
Mantinband discloses evaluating urine color and transparency, detecting abnormal values or trends, and producing alarms and transmitted reports when abnormalities are detected (Mantinband, [0076], [0081], [0117]). Mantinband further explains that such analysis may “determine sudden changes in flow rate or… identify developing trends that may be indicative of medical conditions of clinical interest” (Mantinband, [0116]), thereby expressly supporting trend-based evaluation of urine data for early detection of medical conditions.
Together, Elia and Mantinband teach that urine-flow and urine-property data can be continuously acquired, compared to expected ranges, and used to trigger alarms and electronic notifications when parameters fall outside those ranges, as well as used to populate records suitable for clinical review and trend analysis.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, Tomisaka, Song, Russo, Købke, Elia, Mantinband, and Augustine in view of Augustine, Elia, and Mantinband to provide processing circuitry configured to analyze transmitted flow, color, and weight data, generate automatic alerts when measured parameters fall outside predefined tolerance ranges, maintain comprehensive patient-monitoring records, and enable real-time trend analysis for detection of medical conditions. The combined Goldberg system with added sensors already provides a context in which flow, color, and weight data are available; incorporating the processor-based evaluation, threshold comparison, alerting, and logging logic of Augustine, Elia, and Mantinband would have been a straightforward software and control integration into existing electronic monitoring hardware. The benefit of this combination is to integrate existing urine-flow, color, and weight sensing into automated monitoring that can detect abnormal values and developing trends of clinical interest, reduce reliance on manual charting, and provide earlier, processor-based indication of worsening renal or urinary conditions, as contemplated by Elia and Mantinband.
Also regarding claim 31, the modified Goldberg does not explicitly teach that the system is configured to facilitate uninterrupted fluid collection by automatically directing flow to a second collection container when a first collection container becomes full. The modified Goldberg system relies on the user to observe when a first collection container becomes full and to manually operate the valves to redirect urine flow to the second container. It does not disclose any automatic detection of a full first container or any circuitry or valve mechanism that shifts flow automatically in response to that condition.
Wolff teaches a fluid-collection system that includes sensor-controlled valves that automatically open or close based on whether fluid is detected at a sensing location. Wolff explains that the presence or absence of fluid at the sensor automatically actuates the valve, allowing redirection of flow without requiring user input (Wolff, [0025], [0026]). Wolff therefore teaches the use of fluid-detection sensors and automatic valve actuation to reroute flow in response to fluid-level conditions, directly addressing the missing feature of automatic flow redirection when a container reaches a full state.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Goldberg, Flinchbaugh, Tomisaka, Song, Russo, Købke, Elia, Mantinband, and Augustine in view of Wolff to provide automatic redirection of fluid flow to a second collection container when the first container becomes full. Goldberg already supplies multiple independently operable valves and multiple removable collection containers in a closed drainage system, and Wolff demonstrates that such valves can be equipped with fluid-level sensors that automatically actuate the valve position based on detected fluid conditions. Implementing Wolff’s sensor-controlled solenoid valve arrangement in place of Goldberg’s manually operated valves would have been a predictable substitution of a known automatic valve-control technology into an otherwise conventional multi-container drainage system. The benefit of this combination is to enable automatic, uninterrupted fluid collection, minimize user error, avoid overflow of the first container, and enhance patient safety by allowing the system to autonomously redirect flow when needed, representing a straightforward improvement using known sensor-triggered valve technology.
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Annotated Figure 1
Response to Arguments
Objections
Applicant's arguments filed 10/31/2025, page 11, regarding the previous Objections of claim 21 have been fully considered and are persuasive. The previous Objections have been withdrawn. However, there are new grounds of claim objection (see above).
35 U.S.C. §102&103
Applicant's arguments filed 10/31/2025, pages 11-16, regarding the previous 102 and/or 103 Rejections of claim 21 and 103 Rejections of claims 2-15 and 22-27 have been fully 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. That is, there are new grounds of rejection. The following response addresses only those arguments that relate to limitations previously examined in the Final Office Action. Arguments directed to newly added limitations (e.g., the user-adjustable aspect of the pressure-control valve) are not responsive to the Final Office Action and are addressed solely in the new rejections section of this Office Action.
1. Claim 21 – Goldberg’s Manifold and the “Primary Flow Channel”
Applicant contends that Goldberg teaches a “central manifold hub” and not a “primary flow channel extending from a first terminal end to a second terminal end,” and further argues that the Office’s analysis improperly relied on functional exclusion of unused portions of the manifold. These arguments are not persuasive.
Under BRI, Goldberg’s manifold (10) is a continuous tubular flow passage with identifiable ends, receiving urine at valve 50 and distributing flow via valve ports 30. The claim does not require a straight tube or prohibit intermediate inlets. It simply requires that the input tube define a flow channel from one end to the other with valves located along its length. As explained in the Final Office Action, unused portions of the manifold need not be included in the claimed flow path.
Applicant’s arguments that the Office has “reconstructed” Goldberg are not supported. The rejection properly applied BRI to ignore unclaimed and unused structure, consistent with MPEP § 2144.04, which explains that omission of elements whose functions are not required by the claim is ordinarily an obvious modification. The structural configuration relied upon in the rejection already existed in the pending claims when the Final Office Action issued, and applicant’s remarks do not demonstrate error in that analysis.
Applicant argues that the Office “reconstructed” Goldberg by omitting intermediate ports, but this misstates the rejection. Goldberg operates regardless of how many ports are opened or connected, and the intermediate ports do not perform a required function when not in use. MPEP § 2144.04 makes clear that it is an obvious design choice to omit structures that serve no required role in the modified system. In the configuration relevant to the claim (two valves located at different positions along a continuous tube) Goldberg already provides a continuous, end-to-end primary flow passage. The unused intermediate ports are not required to maintain the prior art’s operability and therefore represent an obvious omission when implementing a two-container configuration. Applicant has not shown that Goldberg requires the unused ports to perform a necessary function in such an implementation.
2. Applicant’s Reliance on MPEP § 2144.04
Applicant argues that MPEP § 2144.04 favors non-obviousness because retaining functionality while altering structure allegedly indicates that the references do not teach the claimed arrangement. This misapplies the section.
The Office did not rely on retaining an omitted function as the basis for obviousness. Instead, the Final Office Action properly cited § 2144.04 for the principle that omitting unnecessary structure, such as unused ports or an unused side of a manifold, would have been an obvious modification when the omitted function is not required by the claim. Applicant’s arguments do not undermine the applicability of this principle. Applicant’s reliance on MPEP § 2144.04 is misplaced. The Office did not rely on retention of an omitted function. Rather, the rejection explains that the omitted structures (unused intermediate ports) do not perform a function required by the combination, and MPEP § 2144.04 expressly states that omission of elements whose function is not required is ordinarily an obvious modification. Goldberg’s drainage manifold continues to operate exactly as intended when unused intermediate ports are not employed (as depicted in FIG. 1), and no essential function is lost. Thus, omitting unused intermediate ports in order to arrive at a primary flow channel extending between two terminal ends is consistent with accepted obviousness principles.
3. Motivation to Modify Goldberg / Alleged Lack of Coherent Explanation
Applicant asserts that the Office failed to articulate a coherent explanation for treating Goldberg’s manifold as meeting the claim or for simplifying Goldberg into a two-port arrangement. These arguments are not persuasive.
The Final Office Action identified Goldberg’s multi-port valved manifold and explained that: (1) the claim reads on the manifold under BRI; and (2) in the alternative, simplifying Goldberg’s multi-port manifold to employ only the ports needed for a two-container system would have been a routine design choice to reduce unused ports and associated components. This rationale is consistent with KSR, which permits reliance on predictable design incentives. Applicant’s statements do not demonstrate reversible error.
4. Pressure-Control Valve and One-Way Valve (Limitations Previously Addressed in Final OA)
Applicant argues that Song allegedly teaches only a fixed, downstream mechanism and that Song’s second one-way valve is only for odor prevention, and therefore cannot be relied on for the pressure-control and one-way valve limitations previously recited in the dependent claims.
These arguments are not persuasive. As explained in the Final Office Action, Song discloses a pressure-responsive mechanism associated with fixed sleeve 5 that remains closed until the urine in the fixed sleeve exerts sufficient pressure to overcome a spring bias and move a slide plate to an open position. This disclosure was properly relied on for the limitations that required a valve which controls flow based on a pressure threshold. The claims previously examined did not require that the sensing and actuating elements be located at a particular point in the line; they required a valve fluidically connected to the inlet that controls flow in response to fluid pressure. Song’s structure satisfies that requirement. In the present amendment, the Examiner relies on Flinchbaugh for the expressly recited user-adjustable pressure setting, but Applicant’s characterization of Song does not show error in the original reliance on Song’s pressure-responsive operation.
With respect to the one-way valve, Applicant focuses on Song’s second valve used for odor control. However, Song also discloses a first one-way valve 501 disposed in fixed sleeve 5 between drainage tube 503 and urine bag 1, such that “under the action of the first one-way valve 501, the urine in the fixed sleeve 5 cannot flow back into the drainage tube 503” when the connector assembly is used and disconnected (Song, FIG. 2, ¶[0023]). Under a broadest reasonable interpretation, this structure is a one-way valve integrated into the connector assembly between the drainage tube and the urine bag that prevents backflow toward the patient. The claims previously examined did not require the one-way valve to be located at a particular axial position within the connector, only that it be associated with the removable connector in a way that prevents backflow from the container side toward the inlet.
Accordingly, the fact that Song’s one-way valve 501 is disposed within the fixed-sleeve portion of the connector assembly, does not distinguish the limitation. Relocating or packaging the known one-way valve structure within the removable connector of Goldberg’s collection container would have been a predictable and routine configuration choice along the same flow path that preserves the same unidirectional-flow function. Applicant’s placement-based arguments therefore do not demonstrate error in the prior reliance on Song for the one-way valve limitation as it existed at the time of the Final Office Action.
5. Motivation to Combine Goldberg and Song
Applicant asserts a lack of teaching or motivation to relocate Song’s pressure mechanism or one-way valve along the fluid path. These arguments mischaracterize the scope of the claims and the basis of the rejection.
The claims do not require any therapeutic function (e.g., bladder exercise) or any particular valve location relative to the patient. Relocating a known pressure-threshold valve or check valve along the same flow path to achieve predictable control and backflow-prevention functions represents a routine design modification under KSR. Applicant has not identified any teaching away or unexpected result that would undermine the stated rationale.
6. Secondary References
Applicant contends that the secondary references cannot cure alleged deficiencies in the combination. However, the Final Office Action provided specific citations mapping each dependent limitation to the teachings of Russo, Wolff, Elia, and other references. Applicant’s generalized assertions do not rebut this detailed mapping.
The references collectively disclose the structures and functionalities relied upon in the rejections, and the combinations were supported by articulated motivations consistent with KSR. No error in the prior analysis has been shown.
7. Effect of Amendments and New Limitations
Applicant has amended independent claim 21 to include additional features not present in the version examined in the Final Office Action (such as the user-adjustable aspect of the pressure-control valve) and has added new claims 28–31. Arguments directed to these newly added limitations are not responsive to the Final Office Action. The patentability of these new limitations is addressed in the new rejections of the present Office Action.
Arguments Conclusion
For the reasons stated above, applicant’s remarks do not demonstrate error in the Final Office Action with respect to the limitations previously examined. The existing rejections are maintained as to those limitations. The newly added limitations are evaluated in the new rejections above.
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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