DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 31, 2026 has been entered.
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 4 and 16 and claims dependent thereon 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 pre-AIA the applicant regards as the invention.
Regarding Claim 4, the term “the sample port… with a second wall that extends laterally relative to a longitudinal axis of the fluid impermeable barrier and defines the port inlet." renders the claim indefinite because it is unclear if Applicant intended to have the laterally extending second wall defines the attachment port as shown in the Figures or if the claim should be read as the sample port additionally defines the port inlet, along with the previously described walls. Examiner will be interpreting the claim as the former. Appropriate changes would include --the sample port… with a second wall that extends laterally relative to a longitudinal axis of the fluid impermeable barrier and defines the attachment port .--.
Regarding Claim 16, the term “an assembly outlet at a proximal end region of the fluid collection assembly with the sample port and chamber spaced distally from the assembly outlet, the assembly outlet being in fluid communication with the chamber and secured to a tube in fluid communication with a storage container effective to provide fluid communication between the chamber and the storage container when the tube is secured to the assembly outlet and the sample container secured to the sample port;" renders the claim indefinite because it is unclear if the storage container is intended to be the same component as “the sample container” or is a newly claimed container. Furthermore, it is unclear what component the term “effective to provide fluid communication between the chamber and the storage container when the tube is secured to the assembly outlet and the sample container secured to the sample port;” is modifying. Appropriate changes would include -- an assembly outlet at a proximal end region of the fluid collection assembly with the sample port and chamber spaced distally from the assembly outlet, the assembly outlet being in fluid communication with the chamber and secured to a tube in fluid communication with the sample container, the assembly outlet is effective to provide fluid communication between the chamber and the sample container when the tube is secured to the assembly outlet and the sample container is secured to the sample port;-- and Examiner will be interpreting the claim as such.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 5-8, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz (US 4,747,166) as noted in Applicant IDS dated 1/31/2022 in view of Weig et al (US 2011/0060300) (“Weig”) as noted in Applicant IDS dated 1/31/2022 and further in view of Chang (US 2003/0222101).
Regarding Claim 1, while Kuntz teaches a fluid collection assembly (Abstract), comprising:
a fluid impermeable barrier including at least one interior surface defining a chamber, the fluid impermeable barrier defining at least one opening (Fig. 4, L. 33-62, covering layers 28c and 36c are made up of polyethylene hydrophobic layers, the layers are sealed together at pad edges 42 and together are the fluid impermeable barrier. These layers together create at least one interior surface defining a chamber / core 40, with the fluid impermeable barrier defining at least one opening / perforations 54 as specifically shown at the top of Fig. 5);
at least one permeable material disposed in the chamber (Fig. 4, L. 33-62, permeable material / highly absorbent cellulosic tissue 44);
a sample port having a port inlet in fluid communication with the chamber and an attachment port (Fig. 7, Col. 6, L. 18-43, cover or cap 14a / sample port has a port inlet / coupling adaptor 70 in fluid communication with the chamber 40 by way of tubing 18 as shown in Fig. 1);
a sample container defining a sample compartment and a sample inlet configured to couple with the attachment port (Fig. 7, Col. 6, L. 18-43, sample container 14’s interior defining a sample compartment and a sample inlet / top of vessel 14 with threads 14c configured to couple with the attachment port / bottom of cover or cap 14a with threaded coupling portion 14b), the sample container having one or more panels that are formed from an at least partially rigid material (Col. 6, L. 18-43, sample container 14 is a glass container);
an assembly outlet at a proximal end region of the fluid collection assembly with the sample port and chamber spaced distally from the assembly outlet, the assembly outlet being in fluid communication with the chamber (Fig. 7, Col. 6, L. 18-43, coupling adaptor 72 at a proximal end region of the fluid collection assembly with the sample port / coupling adaptor 70 and chamber / core 40 spaced distally from the assembly outlet, the assembly outlet being in fluid communication with the chamber);
wherein the sample container is configured to receive a sample of the bodily fluids in the sample compartment when a suction force is applied to the assembly outlet (Fig. 4, Col. 6, L. 18-43, “Urine vapor is drawn into the collection vessel 14 through tube 18, coupling adaptor 70 and elbow pipe 74, by the vacuum source (pump) 16 acting through tube 20 and adaptor 72. Such vapor forms into droplets and collects in the lower part of the vessel.”), and
Kuntz further teaches a fluid collection maintenance component through a urine mist deflector 76, maintaining fluid sample in sample container (Col. 6, L. 18-43), where the sample container’s structure should ensure only air escapes into outlet tubing 20 (Col. 5, L. 59 – Col. 6, L. 17),
Kuntz fails to teach the attachment port being configured to switch between a closed state when a flow of bodily fluids through the attachment port is restricted and an open state when the flow of bodily fluids through the attachment port is permitted; and
However Weig teaches a fluid aspiration system for urine collection (Abstract) comprising
a fluid collection chamber (Fig. 1, [0024] body interface device 12b)
a sample port having a port inlet in fluid communication with the chamber and an attachment port (Fig. 1, [0024]-[0026] sample port / vacuum chamber 3 in fluid communication with the chamber / body interface device 12b with a port inlet / attachment port on right side of Fig. 1, connecting to body interface device 12b by way of control valve 9);
the attachment port being configured to switch between a closed state when a flow of bodily fluids through the attachment port is restricted and an open state when the flow of bodily fluids through the attachment port is permitted (Fig. 1, [0026] attachment port may switch between a closed state when a flow of bodily fluids through the attachment port is restricted and an open state when the flow of bodily fluids through the attachment port is permitted by the operation of control valve 9 and needle valve 8 to ensure proper operation);
and Weig teaches the sample container including nearby valves ([0030] connector valve 6a and drain valve 7b), valves between the port inlet and the sample compartment ([0030] connector valve 6a), and that the valves are configured to control a suction force in relation to bodily fluid levels within the sample compartment ([0030] liquid presence sensor [0045] liquid flow rate sensing for controlled suction)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include a control valve 9 for the sample port of Kuntz as taught by Weig as this provides the ability to control when suction is applied, such as after the system is properly applied to the pelvic area of the patient.
Yet their combined efforts fail to teach the sample container including a check valve between the sample inlet and the sample compartment, the check valve configured to prevent or inhibit a suction force from removing the bodily fluids from the sample compartment.
However Chang teaches a fluid collection device based on suction (Abstract) wherein a sample container of the device may utilize a check valve between a sample inlet and the sample compartment, the check valve configured to prevent or inhibit a suction force from removing the bodily fluids from the sample compartment (Figs. 1-3, [0021]-[0025] a sample container 10 utilizes a check valve 61 with a fluid level indicator 31 to prevent suction force from removing the bodily fluids from the sample compartment).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to add a check valve to ensure the suction of Luntz and Weig is not removing the bodily fluids from the sample compartment as taught by Chang, as this would be counterintuitive to the sampling goals. Furthermore, it would be obvious to set the new check valve between a sample inlet and the sample compartment as Kuntz has already taught that fluid collection maintenance components can be placed in this vicinity with urine deflector 76, has already stated the structure should blocks the release of fluid into tubing 20, and Weig’s system already functions with multiple valves for fluid capture control (control valve 9, needle valve 8, connector valve 6a).
Regarding Claim 5, Kuntz, Weig, and Chang teach the fluid collection assembly of claim 1, further comprising:
a barrier outlet defined by the fluid impermeable barrier, the barrier outlet being disposed between the sample port and the chamber (Fig. 1, Col. 3, L. 35-57, central bore 22, tubing connector 24 / barrier outlet defined by the fluid impermeable barrier, disposed between the sample port / cover or cap 14a and chamber / core 40);
wherein the sample port is distinct from the fluid impermeable barrier (See Claim 1 Rejection, components require tubing couplers 70, reflecting a distinct nature); and
at least one tube extending from the barrier outlet to the port inlet (See Claim 1 Rejection, tubing 18).
Regarding Claim 6, Kuntz, Weig, and Chang teach fluid collection assembly of claim 1, and Weig teaches a second embodiment wherein the sample port defines at least one channel including the assembly outlet positioned downstream from the port inlet, and wherein the at least one channel includes a first channel extending from the port inlet and a second channel extending from the first channel to the attachment port (Fig. 4, [0040]-[0045] where the sample port is the housing containing a control circuit 10, a control valve 20, a single conduit path 5c, with an assembly outlet / top of housing connected to vacuum chamber 3 is downstream from port inlet / inlet connecting to valve 20, and wherein the at least one channel includes a first channel extending from the port inlet which is the path from single conduit path 5c and upwards to vacuum chamber 3 and a second channel extending from the first channel to the attachment port / single conduit path 5c and path downwards to collection chamber 7).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the cover or cap 14a of Kuntz with the housing of Weig’s second embodiment as a simple substitution of one form of connecting a collector, sample container, and vacuum source by a cover (Kuntz) for another with a housing (Weig) to obtain predictable results of reliably collected fluid sample.
Regarding Claim 7, Kuntz, Weig, and Chang teach the fluid collection assembly of claim 1, wherein the sample port includes a valve that is configured to switch the attachment port between the closed state and the open state thereof (See Claim 1 Rejection, Weig’s control valve 9 and connector valve 6a).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to add the connector valve of Weig to the fluid collection system Kuntz, Weig, and Chang to prevent escape of vacuum in the system as necessary when the sample container is disconnected ([0030]).
Regarding Claim 8, Kuntz, Weig, and Chang teach the fluid collection assembly of claim 7, wherein the valve is configured to cause the attachment port to be in the closed state when the sample inlet is not coupled to the attachment port and in the open state when the sample inlet is coupled to the attachment port (See Claim 7 Rejection).
Regarding Claim 16, while Kuntz teaches a method of collecting a sample of bodily fluids (Abstract, Col. 5, L.59 – Col. 6, L. 16), the method comprising:
positioning at least one opening defined by a fluid impermeable barrier of a fluid collection assembly such that the at least one opening is positioned adjacent to or receives a urethra of an individual (Col. 5, L.59 – Col. 6, L. 16, “The pad 12 is positioned in place on a patient to surround the urethral opening.” Fig. 4, Col. 4, L. 33-62, pad 12c includes covering layers 28c and 36c made up of polyethylene hydrophobic layers, the layers are sealed together at pad edges 42 and together are the fluid impermeable barrier), the fluid collection assembly including:
the fluid impermeable barrier including at least one interior surface defining a chamber, the fluid impermeable barrier defining the at least one opening (Fig. 4, Col. 4, L. 33-62, pad 12c has layers together create at least one interior surface defining a chamber / core 40, with the fluid impermeable barrier defining at least one opening / perforations 54 as specifically shown at the top of Fig. 5);
at least one permeable material disposed in the chamber (Fig. 4, L. 33-62, permeable material / highly absorbent cellulosic tissue 44);
a sample port having a port inlet and an attachment port, the port inlet being in fluid communication with the chamber (Fig. 7, Col. 6, L. 18-43, cover or cap 14a / sample port has a port inlet / coupling adaptor 70 in fluid communication with the chamber 40 by way of tubing 18 as shown in Fig. 1), and
a sample container defining a sample compartment and a sample inlet secured the attachment port (Fig. 7, Col. 6, L. 18-43, sample container 14’s interior defining a sample compartment and a sample inlet / top of vessel 14 with threads 14c configured to couple with the attachment port / bottom of cover or cap 14a with threaded coupling portion 14b), the sample container having one or more panels that are formed from an at least partially rigid material (Col. 6, L. 18-43, sample container 14 is a glass container);
an assembly outlet at a proximal end region of the fluid collection assembly with the sample port and chamber spaced distally from the assembly outlet (Fig. 7, Col. 6, L. 18-43, assembly outlet / coupling adaptor 72 at a proximal end region of the fluid collection assembly with the sample port / coupling adaptor 70 and chamber / core 40 spaced distally from the assembly outlet, the assembly outlet being in fluid communication with the chamber);
the assembly outlet being in fluid communication with the chamber and secured to a tube in fluid communication with the sample container (Fig. 7, Col. 6, L. 18-43, assembly outlet / coupling adaptor 72 in fluid communication with chamber / core 40 and secures to a tube 20 in fluid communication with a storage container such as vessel 14) effective to provide fluid communication between the chamber and the sample container when the tube is secured to the assembly outlet (fluid communication actuated by the application of suction, where the suction force is applied through tube 20);
receiving the bodily fluids from the urethra through the at least one opening and into the at least one permeable material disposed in the chamber (Col. 5, - Col. 6, L. 17, “The pad 12 is positioned in place on a patient to surround the urethral opening. It may be held in place by conventional means, such as adhesive, a sanitary belt, a panty garment or the like. The vacuum 65 source or pump 16 is energized by coupling it to an electrical power source with its motor switch closed. The pump then applies a slight vacuum via the tubing 18 and 20 to the bore 22 of the pad 12.”);
removing at least some of the bodily fluids from the chamber via the assembly outlet (Col. 5, - Col. 6, L. 17, “The vacuum source or pump 16 is energized by coupling it to an electrical power source with its motor switch closed. The pump then applies a slight vacuum via the tubing 18 and 20 to the bore 22 of the pad 12.”); and
receiving at least a portion of the bodily fluids into the port inlet and into the sample compartment (Col. 5, L.59 – Col. 6, L. 16, “Once it reaches the bore 22, it is rapidly drawn into the tube 18 and transported to the collection vessel 14.”),
Kuntz fails to teach the attachment port being configured to switch between a closed state when a flow of bodily fluids through the attachment port is restricted and an open state when the flow of bodily fluids through the attachment port is permitted; and
the assembly outlet being effective to provide fluid communication between the chamber and the storage container when the tube is secured to the assembly outlet and the sample container secured to the sample port;
However Weig teaches a fluid aspiration system for urine collection (Abstract) comprising
a fluid collection chamber (Fig. 1, [0024] body interface device 12b)
a sample port having a port inlet in fluid communication with the chamber and an attachment port (Fig. 1, [0024]-[0026] sample port / vacuum chamber 3 in fluid communication with the chamber / body interface device 12b with a port inlet / attachment port on right side of Fig. 1, connecting to body interface device 12b by way of control valve 9);
the attachment port being configured to switch between a closed state when a flow of bodily fluids through the attachment port is restricted and an open state when the flow of bodily fluids through the attachment port is permitted (Fig. 1, [0026] attachment port may switch between a closed state when a flow of bodily fluids through the attachment port is restricted and an open state when the flow of bodily fluids through the attachment port is permitted by the operation of control valve 9 and needle valve 8 to ensure proper operation);
an assembly outlet being effective to provide fluid communication between the chamber and the storage container when the sample container is secured to the sample port ([0030] operation of connector valve 6a);
and Weig teaches the sample container including nearby valves ([0030] connector valve 6a and drain valve 7b), valves between the port inlet and the sample compartment ([0030] connector valve 6a), and that the valves are configured to control a suction force in relation to bodily fluid levels within the sample compartment ([0030] liquid presence sensor [0045] liquid flow rate sensing for controlled suction)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include a control valve 9 for the sample port of Kuntz as taught by Weig as this provides the ability to control when suction is applied, such as after the system is properly applied to the pelvic area of the patient. Further, it would be obvious to use the connector valve of Weig with the connection of a pump via the assembly outlet as these components together indicate the appropriate system components have been added for sampling.
Yet their combined efforts fail to teach a sample container including a check valve between the sample inlet and the sample compartment.
However Chang teaches a fluid collection device based on suction (Abstract) wherein a sample container of the device may utilize a check valve between a sample inlet and the sample compartment, the check valve configured to prevent or inhibit a suction force from removing the bodily fluids from the sample compartment (Figs. 1-3, [0021]-[0025] a sample container 10 utilizes a check valve 61 with a fluid level indicator 31 to prevent suction force from removing the bodily fluids from the sample compartment).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to add a check valve to ensure the suction of Luntz and Weig is not removing the bodily fluids from the sample compartment as taught by Chang, as this would be counterintuitive to the sampling goals. Furthermore, it would be obvious to set the new check valve between a sample inlet and the sample compartment as Kuntz has already taught that fluid collection maintenance components can be placed in this vicinity with urine deflector 76, has already stated the structure should blocks the release of fluid into tubing 20, and Weig’s system already functions with multiple valves for fluid capture control (control valve 9, needle valve 8, connector valve 6a).
Regarding Claim 17, Kuntz, Weig, and Chang teach the method of claim 16, further comprising, before receiving at least a portion of the bodily fluids into the port inlet, coupling the sample inlet to the attachment port (See Claim 16 Rejection).
Regarding Claim 18, Kuntz, Weig, and Chang teach the method of claim 17, wherein coupling the sample inlet to the attachment port switches the attachment port from the closed state to the open state thereof (See Claim 17 Rejection).
Regarding Claim 19, Kuntz, Weig, and Chang teach the method of claim 16, further comprising, after receiving at least a portion of the bodily fluids into a port inlet, decoupling the sample inlet from the attachment port (See Claim 16 Rejection, Weig [0030] a sample container may be decoupled and replaced with a second sample container).
Regarding Claim 20, Kuntz, Weig, and Chang teach the method of claim 16, wherein decoupling the sample inlet from the attachment port switches the attachment port from the open state to the closed state thereof (See Claim 16 Rejection, Weig [0030] a sample container may be decoupled and replaced with a second sample container, with the connector valve switches the attachment port from the open state to the closed state to maintain vacuum).
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Weig and further in view of Chang and further in view of Tsai et al (US 2010/0211032) (“Tsai”) as noted in Applicant IDS dated 1/31/2022.
Regarding Claim 2, Kuntz, Weig, and Chang teach the fluid collection assembly of claim 1, wherein the sample port is spaced distally from the assembly outlet (See Claim 1 Rejection), their combined efforts fail to teach wherein the sample port is integrally formed with the fluid impermeable barrier with the fluid impermeable barrier defining the assembly outlet and the sample port spaced distally from the assembly outlet.
However Tsai teaches an aspiration system for collecting urine (Abstract) comprising an aspiration unit, body interface device and a fluid collection device ([0013], [0034]) where the different components of the aspiration system may be formed integrally or connected together ([0034] “The liquid collection chamber 46 may either be separate from the aspiration unit 12 and coupled thereto with a suitable connector, or the liquid collection chamber 46 may be integral with and/or housed in the aspiration unit 12.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the sample port of Kuntz, Weig, and Chang integrally with the fluid impermeable barrier as taught by Tsai as a simple substitution of one form of structuring connection between the system components (Kuntz: detachable connection) for another (Tsai: non-detachable connection) to obtain predictable results of ensured device connection between system sub-units.
Regarding Claim 3, while Kuntz, Weig, and Chang teach the fluid collection assembly of claim 1, wherein:
the fluid impermeable barrier defines a fluid reservoir distal to the opening (See Claim 1 Rejection, core 40);
the sample port includes a distal wall that is substantially cylindrical and extends distally, with the distal wall defining the port inlet (See Claim 1 Rejection, coupling adaptor 70); their combined efforts fail to teach the sample port is integrally formed with the fluid impermeable barrier; and
the assembly outlet is defined by the fluid impermeable barrier and disposed at a proximal end region of the fluid impermeable barrier.
However Tsai teaches an aspiration system for collecting urine (Abstract) comprising an aspiration unit, body interface device and a fluid collection device ([0013], [0034]) where the different components of the aspiration system may be formed integrally or connected together ([0034] “The liquid collection chamber 46 may either be separate from the aspiration unit 12 and coupled thereto with a suitable connector, or the liquid collection chamber 46 may be integral with and/or housed in the aspiration unit 12.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the sample port of Kuntz, Weig, and Chang integrally with the fluid impermeable barrier as taught by Tsai as a simple substitution of one form of structuring connection between the system components (Kuntz: detachable connection) for another (Tsai: non-detachable connection) to obtain predictable results of ensured device connection between system sub-units.
Regarding Claim 4, while Kuntz, Weig, and Chang teach the fluid collection assembly of claim 1, wherein the sample port includes a proximal wall that is substantially cylindrical and extends proximally from a proximal region of the fluid impermeable barrier, with a second wall that extends laterally relative to a longitudinal axis of the fluid impermeable barrier and defines the attachment port (See Claim 1 Rejection, Kuntz’s coupling adaptor 72 is the proximal wall, Kuntz’s side wall 14d of the cap is the lateral second wall), their combined efforts fail to teach wherein the sample port is formed integrally with the fluid impermeable barrier.
However Tsai teaches an aspiration system for collecting urine (Abstract) comprising an aspiration unit, body interface device and a fluid collection device ([0013], [0034]) where the different components of the aspiration system may be formed integrally or connected together ([0034] “The liquid collection chamber 46 may either be separate from the aspiration unit 12 and coupled thereto with a suitable connector, or the liquid collection chamber 46 may be integral with and/or housed in the aspiration unit 12.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the sample port of Kuntz, Weig, and Chang integrally with the fluid impermeable barrier as taught by Tsai as a simple substitution of one form of structuring connection between the system components (Kuntz: detachable connection) for another (Tsai: non-detachable connection) to obtain predictable results of ensured device connection between system sub-units.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Weig and further in view of Chang and further in view of Bullington et al (US 2019/0365303) (“Bullington”).
Regarding Claim 9, Kuntz, Weig, and Chang teach the fluid collection assembly of claim 8, their combined efforts fail to teach wherein the valve and the sample inlet form a luer lock or a luer slip connection therebetween.
However Bullington teaches a fluid control system (Abstract) wherein valves and sample inlets can be provided by luer lock or a luer slip connections ([0044]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the connector valve and the sample inlet of Weig form a luer lock connection as taught by Bullington as both are recognized as broad structures that may be specifically realized by a luer locks.
Regarding Claim 10, Kuntz, Weig, and Chang teach the fluid collection assembly of claim 1, their combined efforts fail to teach wherein the sample port includes at least one seal across the attachment port and wherein coupling the sample inlet to the attachment port breaks or otherwise damages the at least one seal.
However Bullington teaches a fluid control system (Abstract) wherein a connection is made utilizing at least one seal across a port and wherein coupling breaks or otherwise damages the at least one seal. ([0182], [0058] where such a coupling can also be realized at a port by connection).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the sample port of Kuntz, Weig, and Chang includes at least one seal across the attachment port and wherein coupling the sample inlet to the attachment port breaks or otherwise damages the at least one seal as Bullington teaches this as an appropriate way to maintain a passage closed and this will support the maintaining of a vacuum in the vacuum chamber as desired by Weig.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Weig and further in view of Chang and further in view of Jensen (US 4,533,354).
Regarding Claim 11, Kuntz, Weig, and Chang teach the fluid collection assembly of claim 1, their combined efforts fail to teach wherein the check valve includes a curved barrier extending at least partially between a portion of at least one interior surface of the sample container to an opposing portion of the at least one interior surface.
However Jensen teaches a fluid drainage device (Abstract) comprising a no-turn valve assembly structured as a curved barrier extending at least partially between a portion of at least one interior surface of the sample container to an opposing portion of the at least one interior surface (Fig. 1, Col. 3, L. 22-49, non-return valve 26 structured as a curved barrier at the bottom welds 36, 38).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the check valve of Kuntz, Weig, and Chang be structured as a curved barrier extending at least partially between a portion of at least one interior surface of the sample container to an opposing portion of the at least one interior surface as taught by Jensen as a specific way to structure Kuntz, Weig, and Chang’s valve that inhibits the overfilling of a fluid container.
Claim(s) 12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weig in view of Kuntz and further in view of Chang and further in view of Tsai.
Regarding Claim 12, while Weig teaches a fluid collection system (Abstract), comprising:
A fluid collection assembly (Fig. 1), including:
a barrier including a proximal end region, a distal end region, and at least one interior surface defining a chamber, the barrier defining at least one opening (Figs 1-2, [0034]-[0036] cover component 15 / barrier with internal space divided into two chambers 15a, 15b / chamber, the cover component 15 / barrier defining an opening, proximal end region at left hand-side of Fig. 2, distal end region at right-hand side of Fig. 2), an assembly outlet at the proximal end region (Fig. 2, opening to connecting conduit 31), and a fluid reservoir at the distal end region (Fig. 2, [0034]-[0036] the fluid reservoir being the chamber divider 30 and outer cell open foam 23 which are more resistant to fluid travel, necessitating the action of a vacuum to pull fluid into system);
at least one permeable material disposed in the chamber (Fig. 1-2, [0034]-[0038] inner open cell foam 24 is a permeable material);
a sample port having a port inlet in fluid communication with the chamber and an attachment port (Fig. 1, [0025]-[0030] control valve 9 / sample port has a port inlet at the right-hand side of Fig. 1 connecting to flexible conduit 12c, and two attachment ports at the top and bottom of control valve 9 as shown in Fig. 1, connecting to vacuum paths 5a and 5b), the attachment port being configured to switch between a closed state when a flow of bodily fluids through the attachment port is restricted and an open state when the flow of bodily fluids through the attachment port is permitted (Fig. 1, [0026] attachment port may switch between a closed state when a flow of bodily fluids through the attachment port is restricted and an open state when the flow of bodily fluids through the attachment port is permitted by the operation of control valve 9 and needle valve 8 to ensure proper operation);
a sample container defining a sample compartment and a sample inlet configured to couple with the attachment port (Fig. 1, collection chamber 7 / sample container defined by an internal sample compartment and a sample inlet / connector 6, the sample container is configured to couple with the attachment ports of the sample port / control valve 9 by way of the vacuum paths 5a, 5b, vacuum chamber 3, and connector valve 6a);
a fluid storage container positioned downstream from the fluid collection assembly (Fig. 1, [0030] vacuum chamber 30 is positioned downstream from the fluid collection assembly of the body interface device 12b and the control valve 9, Examiner notes that if fluid is traveling to sample container and a disconnection action occurs, fluid may remain in the vacuum chamber which makes it act as a fluid storage container. Further, the disconnected system status would indicate that the fluid would remain in the fluid storage container / vacuum chamber 3 as the vacuum would be weakened if there is no sample container to divert fluid into)
a vacuum source positioned downstream from the fluid storage container (Fig. 1, pump 2 is downstream from the fluid storage container / vacuum chamber 3); and
wherein when the sample container is secured to the sample port (1) the sample container is in fluid communication with the chamber to receive a portion of the bodily fluids from the chamber and (2) the fluid storage container is in fluid communication with the chamber to receive a portion of the bodily fluids from the chamber (Fig. 1, [0025]-[0030] connection of sample container / collection chamber 7 will have the sample container and the fluid storage container / vacuum chamber 3 in fluid communication with the chamber of body interface device 12b),
Weig fails to teach
The barrier is fluid impermeable;
However Kuntz teaches a fluid collection system (Abstract), comprising:
A fluid collection assembly, including:
a fluid impermeable barrier including a proximal end region, a distal end region, and at least one interior surface defining a chamber, the fluid impermeable barrier defining at least one opening (Fig. 4, L. 33-62, covering layers 28c and 36c are made up of polyethylene hydrophobic layers, the layers are sealed together at pad edges 42 and together are the fluid impermeable barrier. These layers together create at least one interior surface defining a chamber / core 40, with the fluid impermeable barrier defining at least one opening / perforations 54 as specifically shown at the top of Fig. 5. The proximal end region and distal end region are recognized as characteristic of a structure.);
at least one permeable material disposed in the chamber (Fig. 4, L. 33-62, permeable material / highly absorbent cellulosic tissue 44);
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the outer shell of the body interface device of Weig to be fluid-impermeable as taught by Kuntz as a way to control the collection of desired urine and prevent unwanted escape.
Yet their combined efforts fail to teach the sample container including a check valve between the sample inlet and the sample compartment.
However Chang teaches a fluid collection device based on suction (Abstract) wherein a sample container of the device may utilize a check valve between a sample inlet and the sample compartment, the check valve configured to prevent or inhibit a suction force from removing the bodily fluids from the sample compartment (Figs. 1-3, [0021]-[0025] a sample container 10 utilizes a check valve 61 with a fluid level indicator 31 to prevent suction force from removing the bodily fluids from the sample compartment).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to add a check valve to ensure the suction of Kuntz and Weig is not removing the bodily fluids from the sample compartment as taught by Chang, as this would be counterintuitive to the sampling goals. Furthermore, it would be obvious to set the new check valve between a sample inlet and the sample compartment as Kuntz has already taught that fluid collection maintenance components can be placed in this vicinity with urine deflector 76, has already stated the structure should blocks the release of fluid into tubing 20, and Weig’s system already functions with multiple valves for fluid capture control (control valve 9, needle valve 8, connector valve 6a).
Yet their combined efforts fail to teach the sample port being integrally formed with the fluid impermeable barrier at the distal end region of the fluid impermeable barrier.
However Tsai teaches an aspiration system for collecting urine (Abstract) comprising an aspiration unit, body interface device and a fluid collection device ([0013], [0034]) where the different components of the aspiration system may be formed integrally or connected together ([0034] “The liquid collection chamber 46 may either be separate from the aspiration unit 12 and coupled thereto with a suitable connector, or the liquid collection chamber 46 may be integral with and/or housed in the aspiration unit 12.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the sample port of Weig, Kuntz, and Chang integrally with the fluid impermeable barrier as taught by Tsai as a simple substitution of one form of structuring connection between the system components (Weig: spaced apart and detachable connection) for another (Tsai: adjacent integral connection) to obtain predictable results of ensured device connection between system sub-units. Consequently, control valve would be placed past liquid level sensor 13 and around the coupling of connecting conduit 31 to facilitate the integration of the two components.
Regarding Claim 15, Weig, Kuntz, Chang, and Tsai teach the fluid collection system of claim 12, wherein: the vacuum source includes a vacuum pump, a hand operated suction device, or a vacuum line ([0025] vacuum pump 2);
the fluid collection system further includes a tube secured to the assembly outlet and in fluid communication with the chamber through the assembly outlet, the fluid storage container being in fluid communication with the fluid collection assembly via the tube (See Claim 12 Rejection, vacuum paths 5a, 5b are tubes secured to the assembly outlet of control valve 9, which has now been integrated with the fluid impermeable barrier. Vacuum chamber 3 / fluid storage container is in fluid communication with the fluid collection assembly / body interface device 12b + control valve 9 via the tubes / vacuum paths 5a, 5b).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Weig and further in view of Chang and further in view of Tsai and further in view of Bullington.
Regarding Claim 13, while Weig, Kuntz, Chang, and Tsai teach the fluid collection system of claim 12, their combined efforts fail to teach wherein the fluid storage container includes a pouch, a jar, or a canister.
However Bullington teaches a fluid control system (Abstract) where a container under vacuum for receiving a fluid is structured as a canister ([0051]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the vacuum chamber of Weig be structured as a canister as taught by Bullington as a narrowing in structure utilized in Weig, ensuring standardization of invention components and increasing consistency of results across applications of the invention.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Weig and further in view of Chang and further in view of Tsai and further in view of Forral (US 2004/0176746) as noted in Applicant IDS dated 2/13/2024.
Regarding Claim 14, while Weig, Kuntz, Chang, and Tsai teach the fluid collection system of claim 12, their combined efforts fail to teach wherein the fluid storage container includes one or more of a polymer or a glass.
However Forral teaches a urine collection system (Abstract) where a fluid storage container under vacuum for receiving a fluid is made up of a polymer ([0037]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the vacuum chamber of Weig be composed of a polymer as taught by Forral as Forral teaches that a polyethylene collection bottle provides the advantage of “shatter-resistance, low weight, and adequate rigidity.”
Response to Arguments
Applicant’s amendments and arguments filed 1/27/2026 with respect to the claim objections have been fully considered and are persuasive. The objection(s) is/are withdrawn.
Applicant’s amendments and arguments filed 1/27/2026 with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The rejection(s) is/are withdrawn.
Applicant’s amendments and arguments filed 1/27/2026 with respect to the 35 USC 103 rejections have been fully considered and are persuasive. The rejection(s) is/are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kuntz, Weig, and Chang for independent Claims 1 and 16 and Weig, Kuntz, Chang, and Tsai for Claim 12.
Consequently, claims 2-11, 13-15, and 17-20 remain rejected due to their dependency on independent claims.
Conclusion
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights