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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/03/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 13, 15 and all claims depending therefrom are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1, 13 and 15, the new matter is "when the one or more fluid sources contain the fluid, the fluid always flows between the one or more fluid sources and a respective one of the one or more affectors".
Claims 1, 13 and 15, and all claims depending therefrom, are also rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Specifically, it is not clear how the claimed invention could function if fluid were "always flowing between the one or more fluid sources and a respective one of the one or more affectors" as claimed. If fluid were always flowing from the fluid sources then the fluid sources would not be able to perform their intended function of "storing a fluid". Further, constant inflow of fluid from the fluid sopurces into the common reservoir would presumably cause the common reservoir to overflow or back up. Further still, if the affectors are configured to open and close, then closing the affectors would no longer permit fluid to flow from the fluid source to the affectors. The fluid would simply rest between the fluid sources and the affectors and/or rest within the fluid sources themselves, thereby prohibiting the fluid from "always" flowing.
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.
Claims 1, 13, 15 and all claims depending therefrom, 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.
Regarding claim 1, the limitation "the tubing" (line 18) is indefinite because it is not known what specific tubing is being referred to in the claim; the claims require "one or more tubing."
Regarding claim 1, the limitation "the fluid" (line 20) is indefinite because it is not known what specific "fluid" is being referred to in the claim; the claims refer to fluid in numerous instances ("one or more fluid sources for storing a fluid"; "delivery of the fluid to a surgical site"; "fluid exiting from the at least one common reservoir").
Also, it is also unclear what is meant by "when the one or more fluid sources contain the fluid, the fluid always flows between the one or more fluid sources and a respective one of the one or more affectors" (lines 20-22) since it appears to require that the fluid be simultaneously contained by the one or more fluid sources and between the one or more fluid sources and the respective one or more affectors (i.e., not contained by the one or more fluid sources).
Also, it is unclear whether the claimed invention requires that fluid "always" flow between the one or more fluid sources and a respective one or more of the affectors, i.e., fluid must be actively flowing in order for anticipation/infringement to occur, in contrast to an invention where fluid must be merely capable of flowing between the one or more fluid sources and a respective one or more of the affectors.
Also, it is unclear what is meant by "the fluid always flows between the one or more fluid sources and a respective one of the one or more affectors" since it is unclear whether the fluid flows between one of the one or more fluid sources and a respective one of the one or more affectors, or whether the claim permits an invention where fluid can flow between multiple (the "or more" of "one or more") fluid sources and a single effector (the "one" of one or more affectors).
Claims 13 and 15 recite similar limitations and are indefinite for the same reasons set forth above with respect to claim 1.
The claims will be interpreted as described in the rejections, below.
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 4, 6-9, 13-15, 22-24 and 43-48 are rejected under 35 U.S.C. 103 as being unpatentable over Chandler et al (U.S. Pat. 6,024,720, hereinafter “Chandler”) in view of Libermann et al (U.S. Pub. 2003/0176833 A1, hereinafter “Libermann”).
Regarding claims 1, 43 and 46, Chandler discloses a fluid source management system comprising:
a structure (such as tray 90; see Fig. 2) that supports one or more fluid sources 20 (see Figs. 1-2) for storing a fluid (i.e., saline; see col. 5, line 35);
at least one common reservoir 35 (see Fig. 1) for storing the fluid before the fluid is delivered to a surgical site (i.e., the common reservoir is a manifold that is able to store fluid temporarily before it is pumped to the surgical site via a pump 40);
one or more tubing 22 (see Fig. 1) associated with a respective one of the one or more fluid sources for connecting the respective one or more fluid sources 20 to the at least one common reservoir;
an outlet tubing 42 (see Fig. 1) for receiving fluid exiting from the at least one common reservoir and delivering the fluid to the surgical site;
a pump 40 (see Fig. 1) connected to the outlet tubing 42 for delivering the fluid from the outlet tubing to the surgical site;
and a reservoir housing 15 (see Fig. 2) that houses the reservoir (see also Fig. 1 and col. 5, lines 36-40, disclosing that the reservoir 35 is part of the pressurized fluid supply circuit 17 housed in housing 15).
It is noted that Chandler does not appear to disclose:
one or more sensors that determine a fluid state of a respective one of the one or more fluid sources; and
a controller configured to control opening and closing of the tubing based upon the fluid state of the one or more fluid sources in order to maintain continuous delivery of the fluid to a surgical site.
Libermann discloses a fluid source management system comprising:
one or more fluid sources 12, 14 (see Fig. 1 for storing a fluid (see para [0034], disclosing that “At the beginning of the operation, fluid containers 12 and 14 are full”);
one or more sensors 26, 28 (see Fig. 1) that determine a fluid state of a respective one or more of the fluid sources (i.e., sensor 26 determines the fluid state of the fluid source 12, while sensor 28 determines the fluid state of fluid source 14; see para [0034] disclosing that the sensors 26 and 28 “are arranged to determine by weight, volume, optical measurement, or in any other fashion, the quantity of fluid remaining in the associated container, or at least whether the respective container coupled to it is full or almost empty”);
one or more tubing (such as outlet conduits 16 and 18; see Fig. 1) associated with a respective one of the one or more fluid sources for connecting the respective one or more fluid sources to the at least one common reservoir; and
a controller 30 (see Fig. 1) configured to control opening and closing of the tubing based upon the fluid state of the one or more fluid sources (see para [0035] disclosing that the sensor output from sensors 26 and 28, “corresponding to the state of the container is received by controller 30, which, in turn, is coupled to automatic clamping devices 22 and 24”; and see para [0038] disclosing that “When the controller 30 receives a signal from sensor 26 that container 12 is empty or almost empty, controller 30 sends a signal to automatic clamping device 24 mounted on outlet conduit 18 coupled to container 14, causing that automatic clamping device to open”) in order to maintain continuous delivery of the fluid to a surgical site (see para [0019], disclosing that the invention ensures “continuous fluid flow through a conduit to a patient” by automatically switching fluid containers, in order to prevent a break in the fluid flow).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chandler to incorporate one or more sensors that determine a fluid state of a respective one of the one or more fluid sources, and a controller configured to control opening and closing of the tubing based upon the fluid state of the one or more fluid sources in order to maintain continuous delivery of the fluid to a surgical site, as taught in Libermann, in order to provide an early warning to a medical team that a last container is about to become empty (see Libermann at para [0019]).
Further, Chandler does not appear to disclose one or more affectors, each of the one or more affectors corresponding to a respective one of the one or more fluid sources, each of the one or more affectors being located between the respective one of the one or more fluid sources and the common reservoir, wherein each of the one or more affectors is configured to open and close a respective one or more of the tubing, thereby allowing and preventing fluid flow through one of the one or more tubing to the common reservoir, such that when the one or more fluid sources contain the fluid, the fluid is configured to flow between the one or more fluid sources and a respective one of the one or more affectors (interpreted based on the instant claim language "the fluid always flows between the one or more fluid sources and a respective one of the one or more affectors.").
Libermann discloses that its system further comprises one or more affectors 22 and 24 (see Fig. 1), each of the one or more affectors corresponding to a respective one or more of the fluid sources, each of the one or more affectors being located between the respective one or more fluid sources and the common reservoir (i.e., affector 22 corresponds to fluid source 12, while affector 24 corresponds to fluid source 14) and being configured to open and close a respective tubing, thereby allowing and preventing fluid flow through the tubing to the common reservoir (see para [0033] disclosing that the affectors 22 and 24 “can be any type of pinch valve which is capable of sufficient providing pressure on the tubing of the fluid outlet conduits to prevent fluid flow therethrough, including, but not limited to electromagnetic, pneumatic, and hydraulic pinch valves”). Since the fluid sources and the affectors are in fluid communication, fluid is implicitly permitted to flow from the fluid sources to the affectors.
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chandler to incorporate the one or more affectors, as taught in Libermann, for allowing and preventing fluid flow through the tubing to the common reservoir, in order to provide an early warning to a medical team that a last container is about to become empty (see Libermann at para [0019]).
Regarding claim 2, Chandler discloses that the structure comprises at least one arm that supports the one or more fluid sources (i.e., the tray 90 is interpreted to be an “arm” that extends from one side of housing 15 to the other).
Regarding claim 4, Chandler does not appear to disclose that the controller is configured to control opening and closing of affectors that opens and closes the tubing so as to maintain an amount of fluid in the at least one common reservoir.
Libermann discloses that its controller is configured to control opening and closing of affectors that opens and closes the tubing so as to maintain an amount of fluid in the at least one common reservoir (see para [0038] disclosing that “When the controller 30 receives a signal from sensor 26 that container 12 is empty or almost empty, controller 30 sends a signal to automatic clamping device 24 mounted on outlet conduit 18 coupled to container 14, causing that automatic clamping device to open”; in this way, the controller can maintain continuous fluid delivery of the fluid, via the main conduit 20, to the patient).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chandler so that the controller is configured to control opening and closing of affectors that opens and closes the tubing so as to maintain an amount of fluid in the at least one common reservoir, in order to ensure continuous fluid flow through a conduit to a patient (see Libermann at para [0019]), with a reasonable expectation of success.
Regarding claim 6, Chandler does not appear to disclose indicators configured to indicate the fluid state of the one or more fluid sources.
Libermann discloses that its system includes indicators configured to indicate the fluid state of the one or more fluid sources (see para [0048], disclosing an alarm system that can be activated to provide a signal when the fluid in the active container is reduced to about half its volume or when only a single container is left as the active container).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chandler to incorporate indicators configured to indicate the fluid state of the one or more fluid sources, in order to alert a user when it may be time to replace an empty container with a full container, with a reasonable expectation of success.
Regarding claims 7-9, Chandler does not appear to disclose that the controller is configured to maintain at least one affector in an open state and maintain remaining affectors in a closed state or open state.
Libermann discloses that its controller is configured to maintain at least one affector in an open state and maintain remaining affectors in a closed state (see para [0037] disclosing that affector device 24 mounted on outlet conduit 18 coupled to container 14 is closed, while affector 22 is open; in this way, fluid from container 12, alone, flows into main conduit 20 and to the patient). Libermann further discloses that the controller is configured to maintain at least one affector in an open state and maintain remaining affectors in an open or closed state (see para [0037] disclosing that affector device 24 mounted on outlet conduit 18 coupled to container 14 is closed, while affector 22 is open; in this way, fluid from container 12, alone, flows into main conduit 20 and to the patient).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chandler so that controller is configured to maintain at least one affector in an open state and maintain remaining affectors in a closed state, in order to ensure continuous fluid flow through a conduit to a patient (see Libermann at para [0019]), with a reasonable expectation of success.
Regarding claim 13, 44 and 47, Chandler discloses a fluid source management system comprising:
a structure (such as tray 90; see Fig. 2) that supports one or more fluid sources 20 (see Figs. 1-2) for storing a fluid (i.e., saline; see col. 5, line 35);
at least one common reservoir 35 (see Fig. 1) for storing the fluid before the fluid is delivered to a surgical site (i.e., the common reservoir is a manifold that is able to store fluid temporarily before it is pumped to the surgical site via a pump 40);
one or more tubing 22 (see Fig. 1) associated with a respective one of the one or more fluid sources for connecting the respective one or more fluid sources 20 to the at least one common reservoir;
an outlet tubing 42 (see Fig. 1) for receiving fluid exiting from the at least one common reservoir and delivering the fluid to the surgical site;
a pump 40 (see Fig. 1) connected to the outlet tubing 42 for delivering the fluid from the outlet tubing to the surgical site;
and a reservoir housing 15 (see Fig. 2) that houses the reservoir (see also Fig. 1 and col. 5, lines 36-40, disclosing that the reservoir 35 is part of the pressurized fluid supply circuit 17 housed in housing 15).
It is noted that Chandler does not appear to disclose:
one or more sensors that determine a fluid state of a respective one of the one or more fluid sources; and
a controller configured to control opening and closing of the tubing based upon the fluid state of the one or more fluid sources in order to maintain continuous delivery of the fluid to a surgical site.
Libermann discloses a fluid source management system comprising:
one or more fluid sources 12, 14 (see Fig. 1 for storing a fluid (see para [0034], disclosing that “At the beginning of the operation, fluid containers 12 and 14 are full”);
one or more sensors 26, 28 (see Fig. 1) that determine a fluid state of a respective one or more of the fluid sources (i.e., sensor 26 determines the fluid state of the fluid source 12, while sensor 28 determines the fluid state of fluid source 14; see para [0034] disclosing that the sensors 26 and 28 “are arranged to determine by weight, volume, optical measurement, or in any other fashion, the quantity of fluid remaining in the associated container, or at least whether the respective container coupled to it is full or almost empty”);
a controller 30 (see Fig. 1) configured to control opening and closing of the tubing based upon the fluid state of the one or more fluid sources (see para [0035] disclosing that the sensor output from sensors 26 and 28, “corresponding to the state of the container is received by controller 30, which, in turn, is coupled to automatic clamping devices 22 and 24”; and see para [0038] disclosing that “When the controller 30 receives a signal from sensor 26 that container 12 is empty or almost empty, controller 30 sends a signal to automatic clamping device 24 mounted on outlet conduit 18 coupled to container 14, causing that automatic clamping device to open”) in order to maintain continuous delivery of the fluid to a surgical site (see para [0019], disclosing that the invention ensures “continuous fluid flow through a conduit to a patient” by automatically switching fluid containers, in order to prevent a break in the fluid flow).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chandler to incorporate one or more sensors that determine a fluid state of a respective one of the one or more fluid sources, and a controller configured to control opening and closing of the tubing based upon the fluid state of the one or more fluid sources in order to maintain continuous delivery of the fluid to a surgical site, as taught in Libermann, for ensuring continuous fluid flow through a conduit to a patient by automatically switching of fluid containers—or providing an early warning to a medical team that a last container is about to become empty—in order to prevent a break in the fluid flow (see Libermann at para [0019]).
Further, Chandler does not appear to disclose one or more affectors, each of the one or more affectors corresponding to a respective one of the one or more fluid sources, each of the one or more affectors being located between the respective one of the one or more fluid sources and the common reservoir and being configured to open and close a respective tubing, thereby allowing and preventing fluid flow through the tubing to the common reservoir.
Libermann discloses that its system further comprises one or more affectors 22 and 24 (see Fig. 1), each of the one or more affectors corresponding to a respective one or more of the fluid sources, each of the one or more affectors being located between the respective one or more fluid sources and the common reservoir (i.e., affector 22 corresponds to fluid source 12, while affector 24 corresponds to fluid source 14) and being configured to open and close a respective tubing, thereby allowing and preventing fluid flow through the tubing to the common reservoir (see para [0033] disclosing that the affectors 22 and 24 “can be any type of pinch valve which is capable of sufficient providing pressure on the tubing of the fluid outlet conduits to prevent fluid flow therethrough, including, but not limited to electromagnetic, pneumatic, and hydraulic pinch valves”). Since the fluid sources and the affectors are in fluid communication, fluid is implicitly permitted to flow from the fluid sources to the affectors.
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chandler to incorporate the one or more affectors, as taught in Libermann, for allowing and preventing fluid flow through the tubing to the common reservoir, in order to provide an early warning to a medical team that a last container is about to become empty (see Libermann at para [0019]).
Regarding claim 14, Chandler does not appear to disclose that its controller is configured to control the flow of fluid from the one or more fluid sources based on a fluid level of the one or more fluid sources.
Libermann discloses that its controller is configured to control the flow of fluid from the one or more fluid sources based on a fluid level of the one or more fluid sources (i.e., sensor 26 determines the fluid state of the fluid source 12, while sensor 28 determines the fluid state of fluid source 14; see para [0034] disclosing that the sensors 26 and 28 “are arranged to determine by weight, volume, optical measurement, or in any other fashion, the quantity of fluid remaining in the associated container, or at least whether the respective container coupled to it is full or almost empty”; then, the controller 30 receives a signal from sensor 26 that container 12 is empty or almost empty, controller 30 sends a signal to automatic clamping device 24 mounted on outlet conduit 18 coupled to container 14, causing that automatic clamping device to open”).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chandler so that its controller is configured to control the flow of fluid from the one or more fluid sources based on a fluid level of the one or more fluid sources, as taught in Libermann, for ensuring continuous fluid flow through a conduit to a patient by automatically switching of fluid containers—or providing an early warning to a medical team that a last container is about to become empty—in order to prevent a break in the fluid flow (see Libermann at para [0019]).
Regarding claim 15, 45 and 48, Chandler discloses a fluid source management system comprising:
a structure (such as tray 90; see Fig. 2) that supports one or more fluid sources 20 (see Figs. 1-2) for storing a fluid (i.e., saline; see col. 5, line 35);
at least one common reservoir (portion of element 35 where sensor 51 is located; see Fig. 4) for storing the fluid before the fluid is delivered to a surgical site (i.e., the common reservoir stores a small amount of fluid before it is pumped to the surgical site via a pump 40);
one or more tubing 22 (see Fig. 1) associated with a respective one of the one or more fluid sources for connecting the respective one or more fluid sources 20 to the at least one common reservoir;
a connector manifold (assembly of multiple ports 23 shown in Fig. 4) configured to be attached to the at least one common reservoir (see Fig. 4), the connector manifold forming a fluid connection between the one or more tubing and the at least one common reservoir (see Fig. 4);
an outlet tubing 42 (see Fig. 1) for receiving fluid exiting from the at least one common reservoir and delivering the fluid to the surgical site;
a pump 40 (see Fig. 1) connected to the outlet tubing 42 for delivering the fluid from the outlet tubing to the surgical site;
and a reservoir housing 15 (see Fig. 2) that houses the reservoir (see also Fig. 1 and col. 5, lines 36-40, disclosing that the reservoir 35 is part of the pressurized fluid supply circuit 17 housed in housing 15).
It is noted that Chandler does not appear to disclose:
one or more sensors that determine a fluid state of a respective one of the one or more fluid sources;
one or more affectors, each of the one or more affectors corresponding to a respective one of the one or more fluid sources, each of the one or more affectors being located between a respective one of the one or more fluid sources and the at least one common reservoir and being configured to open and close a respective tubing, thereby allowing and preventing fluid flow through the tubing to the at least one common reservoir;
a controller configured to control opening and closing of the tubing based upon the fluid state of the one or more fluid sources in order to maintain continuous delivery of the fluid to a surgical site.
Libermann discloses a fluid source management system comprising:
one or more sensors 26, 28 (see Fig. 1) that determine a fluid state of a respective one or more fluid sources (i.e., sensor 26 determines the fluid state of the fluid source 12, while sensor 28 determines the fluid state of fluid source 14; see para [0034] disclosing that the sensors 26 and 28 “are arranged to determine by weight, volume, optical measurement, or in any other fashion, the quantity of fluid remaining in the associated container, or at least whether the respective container coupled to it is full or almost empty”);
one or more affectors 22 and 24 (see Fig. 1), each of the one or more affectors corresponding to a respective one of the one or more fluid sources, each of the one or more affectors being located between a respective one of the one or more fluid sources and the at least one common reservoir (i.e., affector 22 corresponds to fluid source 12, while affector 24 corresponds to fluid source 14) and being configured to open and close a respective tubing, thereby allowing and preventing fluid flow through the tubing to the one or more common reservoir (see para [0033] disclosing that the affectors 22 and 24 “can be any type of pinch valve which is capable of sufficient providing pressure on the tubing of the fluid outlet conduits to prevent fluid flow therethrough, including, but not limited to electromagnetic, pneumatic, and hydraulic pinch valves”; since the fluid sources and the affectors are in fluid communication, fluid is implicitly permitted to flow from the fluid sources to the affectors);
a controller 30 (see Fig. 1) configured to control opening and closing of the one or more affectors based on the fluid state of the one or more fluid sources (see para [0035] disclosing that the sensor output from sensors 26 and 28, “corresponding to the state of the container is received by controller 30, which, in turn, is coupled to automatic clamping devices 22 and 24”; and see para [0038] disclosing that “When the controller 30 receives a signal from sensor 26 that container 12 is empty or almost empty, controller 30 sends a signal to automatic clamping device 24 mounted on outlet conduit 18 coupled to container 14, causing that automatic clamping device to open”) in order to maintain continuous delivery of the fluid to a surgical site (see para [0019], disclosing that the invention ensures “continuous fluid flow through a conduit to a patient” by automatically switching fluid containers, in order to prevent a break in the fluid flow).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chandler to incorporate one or more sensors that determine a fluid state of a respective one of the one or more fluid sources, one or more affectors, each of the one or more affectors corresponding to a respective one of the one or more fluid sources, each of the one or more affectors being located between a respective one of the one or more fluid sources and the at least one common reservoir and being configured to open and close a respective tubing, thereby allowing and preventing fluid flow through the tubing to the at least one common reservoir, and a controller configured to control opening and closing of the tubing based upon the fluid state of the one or more fluid sources in order to maintain continuous delivery of the fluid to a surgical site, as taught in Libermann, for ensuring continuous fluid flow through a conduit to a patient by automatically switching of fluid containers—or providing an early warning to a medical team that a last container is about to become empty—in order to prevent a break in the fluid flow (see Libermann at para [0019]).
Regarding claims 22-24, Chandler does not appear to disclose that the controller is configured to maintain at least one affector in an open state and maintain remaining affectors in a closed state or open state.
Libermann discloses that its controller is configured to maintain at least one affector in an open state and maintain remaining affectors in a closed state (see para [0037] disclosing that affector device 24 mounted on outlet conduit 18 coupled to container 14 is closed, while affector 22 is open; in this way, fluid from container 12, alone, flows into main conduit 20 and to the patient). Libermann further discloses that the controller is configured to maintain at least one affector in an open state and maintain remaining affectors in an open or closed state (see para [0037] disclosing that affector device 24 mounted on outlet conduit 18 coupled to container 14 is closed, while affector 22 is open; in this way, fluid from container 12, alone, flows into main conduit 20 and to the patient).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chandler so that controller is configured to maintain at least one affector in an open state and maintain remaining affectors in a closed state, in order to ensure continuous fluid flow through a conduit to a patient (see Libermann at para [0019]), with a reasonable expectation of success.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Chandler, in view of Libermann, further in view of Deckert et al (U.S. Pat. 4,681,563, hereinafter “Deckert”).
Regarding claim 5, it is noted that Chandler, in view of Libermann, does not appear to disclose adapter blocks that encapsulate the tubing; a tubing support structure having tubing acceptance bays formed therein that are configured to removably receive the adapter blocks, wherein the affectors are positioned in the tubing support structure such that the affectors can extend into a corresponding tubing acceptance bay and adapter block thereby interacting with the tubing to open and close the tubing.
Deckert discloses a fluid source management system comprising:
a structure (such as an IV stand 16; see Fig. 1) that supports one or more fluid sources 18A, 18B (see Fig. 1) for storing a fluid;
adapter blocks 28 (Fig. 8) that encapsulate tubing 26 associated with each of the fluid sources; and
a tubing support structure 12 (Fig. 8) having tubing acceptance bays formed therein (i.e., the bay where regulator shaft is located) that are configured to removably receive the adapter blocks (i.e., by opening or closing a door 25);
wherein affectors, such as regulator shafts 33 that applies clamp pressure to the tubing to control the rate of fluid flow through the tubing 26 (see col. 3, lines 30-40) are positioned in the tubing support structure 12, such that the affectors can extend into a corresponding tubing acceptance bay (see Fig. 8 showing the affector located in the tubing acceptance bay) and adapter block (through window 31 formed in door 25) thereby interacting with the tubing to open and close the tubing 26 (see col. 3, lines 30-40).
A skilled artisan would have found it obvious at the time of the invention to modify the system of Chandler, in view of Libermann, to incorporate adapter blocks that encapsulate the tubing; a tubing support structure having tubing acceptance bays formed therein that are configured to removably receive the adapter blocks, wherein the affectors are positioned in the tubing support structure such that the affectors can extend into a corresponding tubing acceptance bay and adapter block thereby interacting with the tubing to open and close the tubing, as taught in Deckert, as a well-known structure for facilitating the reception of the tubing associated with the affector (see Deckert at col. 3, lines 24-26), ensuring proper alignment of the tubing with the affector (see Deckert at col. 3, lines 28-34), with a reasonable expectation of success.
Claims 10, 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Chandler, in view of Libermann, further in view of Wurm (U.S. Pub. 2022/0185538 A1, hereinafter “Wurm”).
Regarding claims 10, 11 and 19, it is noted that Chandler, in view of Libermann, does not appear to disclose that the common reservoir comprises a structure that prevents the common reservoir from collapsing, the structure comprising a three-dimensional polygon.
Wurm discloses a device for protecting tubing protruding from a container, containing a therapeutic fluid. The device comprises a structure preventing the tubing from collapsing, the structure comprising a three-dimensional polygon (such as a rectangle or other polygon (see para [0043]).
A skilled artisan would have found it obvious at the time of the invention to modify the system of Chandler, in view of Libermann, so as to incorporate a structure in the shape of a three-dimensional polygon, in order to prevent he common reservoir (i.e., the medical line 104) from collapsing.
Claim 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chandler, in view of Libermann, further in view of Wright et al (U.S. Pat. 10,064,987, hereinafter “Wright”).
Regarding claim 16, it is noted that Chandler, in view of Libermann, does not appear to disclose a tubing support structure having at least two tubing acceptance bays formed therein, wherein the connector manifold comprises at least two protuberances that are configured to be removably fit into a corresponding one of the at least two tubing acceptance bay. Further, regarding claim 18, Libermann does not appear to disclose that the tubing support structure comprises a shelf formed in the bottom thereof that is configured to hold the common reservoir.
Wright discloses a fluid administration system for medical fluid, comprising a tubing support structure (combination of 123, 124, 127; see Fig. 2) having at least two tubing acceptance bays formed therein, wherein a connector manifold comprises at least two protuberances (shown as connections between the manifold and the tubing 122) that are configured to be removably fit into a corresponding one of the at least two tubing acceptance bays (although not labeled, Fig. 3 shows a slot formed into the door 109 where the manifold would be seated into).
Further, regarding claim 18, Wright discloses that the tubing support structure comprises a shelf formed in the bottom thereof that is configured to hold the common reservoir (a variety of flat surfaces can “hold” the common reservoir in the manner of a shelf, if the line 104 were placed thereon, such as the slots 124).
A skilled artisan would have found it obvious at the time of the invention to modify the system of Chandler, in view of Libermann, to incorporate a tubing support structure having at least two tubing acceptance bays formed therein, wherein the connector manifold comprises at least two protuberances that are configured to be removably fit into a corresponding one of the at least two tubing acceptance bay, such that the tubing support structure comprises a shelf formed in the bottom thereof that is configured to hold the common reservoir, in order to provide a well-known structure for facilitating the reception of the tubing, ensuring proper alignment of the tubing in the manifold, with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed in the Remarks on 04/03/2026 have been fully considered.
The previous rejection of claims under 35 U.S.C. 112(b), as being indefinite, has been maintained in light of Applicant’s arguments.
Applicant argued that “claim 13 has been amended here to recite 'each of the one or more tubing is associated with a respective one of the one or more fluid sources’ which means that each tubing is associated with one fluid source.” (See Remarks, pg. 11).
But it is unclear whether claim 13 (along with claims 1 and 15) cover an invention where fluid can flow between multiple (the "or more" of "one or more") fluid sources and a single effector (the "one" of one or more affectors). 35 U.S.C. 112(b) requires that a patent application 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. In this case, it is not clear whether the inventor regards the invention as being one where fluid can flow between multiple (the "or more" of "one or more") fluid sources or a single effector (the "one" of one or more affectors).
Regarding the rejections of claims under 35 U.S.C. 103, Applicant argued that Chandler would have “no need to have affectors that opens and closes the tubing” because Chandler’s spiker structure “ensure[s] uninterrupted flow of sterile solution to a body cavity” and that modifying Chandler to “to include affectors and being configured to open and close a tubing would completely change the principle of operation” of Chandler (see Remarks, pg. 12, citing Chandler at Fig. 1 and col. 5, lines 50-54).
First, it is noted that the portion of Chandler cited by Applicant states that the spiker structure allows “fluid to flow along the cabinet supply conduits 22 to a manifold 35 in an uninterrupted manner” (emphasis added), not uninterrupted flow to a body cavity. A skilled artisan would interpret “fluid flow…in an uninterrupted manner” to mean fluid flow that does not require interrupting an operation to change bags (see Chandler col. 4, lines 3-8); indeed, Chandler teaches that its controller could halt the flow to the body cavity when necessary (see col. 15, lines 33-47), and so changing or halting the flow of fluid is fully consistent with the principle of operation of Chandler.
Libermann is not concerned with affectors that disrupt the flow of fluid to the cavity, as alleged by Applicant; rather, the individual affector associated with each bag does the opposite: it opens to start the flushing procedure of the respective bag, remains open during the entire flushing process, and then closes when the fluid bag is empty or close to empty (see Libermann at paras [0037]-[0038]).
Therefore, modifying the device of Chandler to include these affectors would not change the principle of operation of Chandler, because the affectors in Libermann are designed to open to allow fluid to flow into the manifold, and then close when (or nearly when) no more that the fluid should stop flowing. The affectors of Libermann advantageously provide not only uninterrupted flow of fluid from multiple bags without requiring the bags to replaced, but also the early warning to a medical team that a last container is about to become empty (see Libermann at para [0019]).
Applicant also argued that "wherein when the one or more fluid sources contain the fluid, the fluid always flows between the one or more fluid sources and a respective one of the one or more affectors". Applicant argued that there is no flow of fluid from bags 20 to conduits 22 until a spiker assembly is actuated (see Remarks, pg. 13).
But in order for the Chandler device to perform its intended function of delivering fluid to a surgical site, the saline bags must be spiked. When the bags are spiked, therefore, fluid would flow between the bags and the affectors. Examiner also notes that Applicant's disclosure does not have support for the claimed invention being configured so that "[a]s long as there is fluid in the [fluid] sources, the fluid always will flow to the affectors" as alleged in Applicant's arguments (see Remarks, pg. 13).
Regarding the rejection of claim 5, Applicant appeared to argue that the features of Deckert cannot be bodily incorporated into the structure of Chandler, because the Office has not articulated “how” combining the features of Deckert with those of Chandler and Libermann would have had a reasonable expectation of success (see Remarks, pg. 14).
But the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference (i.e., how the relied upon components of Deckert would function with the components of Chandler); nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). See also In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012) (“It is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements.”); and In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc) (explaining that whether one reference can be incorporated in another is “basically irrelevant” since the test for obviousness is “not whether the references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole”).’
In this case, a person of skill in the art would not have required extraordinary creativity to fit tubing into an adapter block or the adapter blocks into a tubing support structure, nor to fit affectors into place where they could extend into an acceptance bay to perform their intended function of blocks that encapsulate the tubing; a tubing support structure having tubing acceptance bays formed therein that are configured to removably receive the adapter blocks, wherein the affectors are positioned in the tubing support structure such that the affectors can extend into a corresponding tubing acceptance bay and adapter block thereby interacting with the tubing to open and close the tubing within the bays.
Moreover, Applicant has not provided any evidence for why the relied-upon features of Chandler and Deckert are “structurally incompatible” with each other.
Conclusion
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 07/23/2026
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