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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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