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 .
Remarks
This office action fully acknowledges Applicant’s arguments and amendments filed 08 August 2025.
Claims 18-25, 27-28, 30, and 32-41 are pending.
Claims 1-17, 26, 29, and 31 are cancelled.
No claims are withdrawn.
Claim 41 is newly added.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 41 is 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 41 recites “the second container remaining housed in the receiving structure”; however, Claim 33, on which Claim 41 depends, recites “placing the container assembly housed in the second container in the receiving structure”, not placing the second container in the receiving structure. It is thereby unclear what element is intended to be received by the receiving structure, thus rendering the intended arrangement of structures indefinite.
Claim 41 further recites “when replacement is needed”. The term “is needed” in Claim 41 is a relative term which renders the claim indefinite. The “is needed” provision 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 as to what constitutes the container “needing replacement”.
Claim Rejections - 35 USC § 103
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 18-25, 27-28, 30, 32-34, 36, and 41, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Walters et al. (US 2007/0116599 A1), referred to hereinafter as “Walters”, in view of Pomeroy et al. (US PAT 5,559,032), referred to hereinafter as “Pomeroy”, Wrench et al. (US 2014/0261868 A1), referred to hereinafter as “Wrench”, and Trump et al. (US2016/0296936A1), referred to hereinafter as “Trump.”.
Regarding Claim 18, Walters teaches a fluid container device for delivering fluid from a vessel, comprising a container assembly comprising:
a first container 44 (“shelf-like thermoformed containers 44”) having a first opening 73 (Fig. 14);
a vessel 63 (“pouch 63”) having a second opening 63M (Fig. 4),
the vessel 63 being mounted within the first container 44 such that the first opening 73 and the second opening 63M are in alignment (Fig. 13 and [0064]: “…first tray section 70 and second tray section 71 are folded together to form a sealed and closed inner shell suitable for holding and protecting a single pouch 63…” – Fig. 13 further demonstrates that when the pouch 63 and vessel 44 are assembled, the first opening 73 and the second opening 63M are in alignment.);
a septum member 64/54/55 mounted to the first and second openings 73/63M (Fig. 13 shows that septum 54 is mounted to the first and second openings 73 and 63M respectively.)
wherein the first container comprises at least one wall surrounding the vessel (See Fig. 11C showing a wall (continuous sidewall of the hard-shelled container device) for clamping around and thereby surrounding the vessel.),
as in Claim 18.
Further regarding Claim 18, Walters does not specifically teach the container assembly discussed above wherein the container device comprises a second container, and said second container has an internal housing and is arranged to receive said container assembly inside its internal housing, said container assembly being entirely contained within the second container, and wherein the second container includes an introduction opening for the introduction of the container assembly inside its housing and a rear end part arranged to close hermetically, in a reversible manner, the introduction opening, as in Claim 18.
However, Pomeroy teaches an outer storage chamber 30 (the second container) having a gas inlet valve, and containing reagent pouches 48, wherein pumping pressurized gas into said storage chamber 30 causes liquid to flow out of said pouches 48 (Col. 7, line 15: “A reagent storage chamber 30…contains numerous pouches 48 prefilled with reagents 52. An air pump 18 is positioned beside or under the storage chamber 30 and is connected with the inside of the chamber 30 by connecting metal tubing 17 of which outlet 19 is positioned inside of the chamber 30. The air pump 18 pressurizes the chamber 30 with adequate positive pressure in pounds of air per square inch of sufficient force (psi) to squeeze the reagent pouch 48 to force the reagent 52 through the tubing 42 to enter the reaction chamber 28.”). Further, Pomeroy teaches the container assemblies/reagent pouches 48 as being entirely contained within the storage chamber 30 (See Fig. 2 showing the pouches 48 with reagents 52 inside the sealed pressure-controlled box, and Fig. 6 showing the storage chamber 30 sealed by the lid 46. Therein, this arrangement provides a sealed environment for pressure to be altered by gas added or removed via the gas pressure lines as seen in Fig. 2. Further, Pomeroy teaches wherein the second container 30 includes an introduction opening for the introduction of a reagent pouch inside its housing (See Fig. 6 showing the reagent container having an upper introduction opening for receiving the reagent pouches 48. – See also col. 6, lines 62-65: “A reagent storage chamber 30 has a lid 46 (FIG. 3) which allows opening the chamber 30 to refill the reagent holding pouches 48 with reagent 52.”) and a rear end part 46/31 arranged to close hermetically, in a reversible manner, the introduction opening (See Fig. 6 showing the reagent container having an upper introduction opening which is covered by the lid 46 and hermetically sealed by the seal 31. – See also col. 7, lines 17-21: “The preferred embodiment of the reagent storage chamber 30 has a lid 46 which allows the chamber 30 to be completely sealed to allow the containment and pressurization of air within the reagent storage chamber 30.”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the assembly taught by Walters to include providing a second container having an internal housing, said container assembly being placed inside said internal housing, such as suggested by Pomeroy, so as to induce a tunable, active flow out of the pouches and into a device at-hand, and wherein said container assembly is substantially entirely contained within the internal housing of the second container, as seen in Pomeroy, so as to enable the sought pressure-based fluid actuation in Pomeroy only possible in a sealed container, and further wherein the second container includes an introduction opening for the introduction of the container assembly inside its housing and a rear end part arranged to close hermetically, in a reversible manner, the introduction opening, such as suggested by Pomeroy, so as to provide the architecture of Pomeroy needed for achieving the desired pressure-based actuation of replaceable reagent fluid pouches, providing an opening for replacement of the reagent units, and a sealable lid to preserve the pressurization function of liquid actuation in Pomeroy when implemented in Walters.
Further regarding Claim 18, Walters does not specifically teach the container assembly discussed above wherein the second container comprises a gas pressurized input port in fluid communication with, a first space between an exterior of the vessel and an interior of the first container, and a second space between the exterior of the first container and an interior of the second container, as in Claim 18.
However, Wrench teaches a respective container device wherein an internal fluid bag 102 is contained within a rigid outer shell 110, and wherein said rigid outer shell 110 comprises a gas pressurized input port 108 (“gas interface port 108”) in fluid communication with, a first space 104 (“interstitial volume 104”) between an exterior of the vessel 102 and an interior of the first container 110. Wrench further teaches a second container 114 into which the rigid outer shell 110 is inserted, wherein a pressurized gas input port 118 connects a second space between the exterior of the first container and an interior of the second container 114 (Figs. 1 and 2 and [0053]: “The interstitial volume can be fluidity connected to a fluid interface port, which can provide a flow path for the fluid medium in the interstitial volume to enter into an instrument. As pressurized gas fills the gas bag, the volume of the interstitial volume is reduced, thereby pushing fluid medium in the interstitial volume out through the egress of the fluid interface port.”).
Walters teaches passive gravity-driven flow of reagents while Wrench conversely teaches active pressure-driven flow, wherein pressure-driven flow is more controllable and reproducible than gravity-driven flow, which may be more easily affected by viscosity or interrupted by blockages in the fluidic elements of a system.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container device of Walters with a pressurized gas inlet port, such as taught by Wrench, so as to provide a sufficient structure to induce an active and controllable liquid reagent flow from a flexible internal bag contained within a rigid housing to provide liquid reagents to a fluid handling and/or analysis apparatus.
Further regarding Claim 18, Walters does not specifically teach the container device discussed above wherein the wall comprises one or several holes(s) whose number, size and distribution are configured to put the first space in fluid communication with the second space, as in Claim 18
However, Trump teaches a respective fluid container device wherein a rigid outer bottle contains a thin and flexible inner bag that is filled with a liquid reagent. Walters further teaches that the inner bag collapses when emptied and thus provides a through hole to the rigid outer bottle for pressure equalization to allow the inner bag to easily collapse ([0067]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container assembly taught by Walters with at least one through hole provided to the first/outer container, such as taught by Trump, so as to allow pressure equalization when the bag collapses as reagent contained therein is used up, thus allowing said bag to easily collapse without negative pressure interference.
Further regarding Claim 18, the recitation “wherein the container assembly is a single-use container assembly, removable from the second container, and the second container is reusable” is drawn to an intended use limitation not holding particular patentable weight. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). When an apparatus is claimed, its patentability is based on the structure of the apparatus and not on the function it performs or the field in which it is applied. In this case, whether the container assembly is intended to be used only once while the second container is reusable is immaterial, as the structure of the respective containers and their respective functions of protecting a reagent pouch and pressurizing the pouch to dispense its contents remain the same. No structural or functional limitations are imparted by the recitation; thus, it is not given weight herein and is thereby not required of the prior art.
Regarding Claim 19, the prior art meets the limitations of Claim 18 as discussed above. Further, Walters teaches the container assembly discussed above wherein:
the septum member is in alignment with the first and second openings 73/63M (Fig. 13), as in Claim 2.
Regarding Claim 20, the prior art meets the limitations of Claim 18 as discussed above. Further, Walters teaches the container assembly discussed above wherein:
the septum member 64/54/55 comprises a septum support 64/55 having a first portion 64F secured to the vessel 63 (Figs. 9, 10, and 11),
and a second portion 64B secured to a septum maintaining portion 64R-lower (Fig. 10 and [0062]: “…the lower set of ridges 64R is provided for sealing septum 54 onto fitment 64 using cap 55.”), as in Claim 20.
Regarding Claim 21, the prior art meets the limitations of Claim 20 as discussed above. Further, Walters teaches the container assembly discussed above wherein:
the septum support 64/55 comprises a third portion 64B-upper secured to the first container 44 ([0062]: “The upper set of ridges 64R is provided for sealing fitment 64 into clam-shell-like thermoformed container 44…”), as in Claim 21.
Regarding Claim 22, the prior art meets the limitations of Claim 18 as discussed above. Further, Walters teaches the container assembly discussed above wherein:
the vessel comprises a connecting portion (the inner surface of opening 63M as seen in Fig. 9) secured to the septum member 64/54/55 ([0062]: “Weld sealing foils 64S flare outwardly and are tapered to a fin 64F on opposed ends of sealing foils 64S in order to facilitate the integrity of the heat-induced seal within the mouth-like opening 63M of body 63B”), as in Claim 22.
Regarding Claim 23, the prior art meets the limitations of Claim 20 as discussed above. Further, Walters teaches the container assembly discussed above wherein:
the vessel comprises a connecting portion secured to the septum member, and connecting portion secured to the septum member is sandwiched between the first portion 64F of the support member and the first container 44 (Fig. 13 shows that when assembled, the connecting portion (the inner surface of opening 63M as seen in Fig. 9) is sandwiched between the first portion 64F (Fig. 10) and the first container 44. Fig. 13B shows the connecting portion secured to the septum member 64.), as in Claim 23.
Regarding Claim 24, the prior art meets the limitations of Claim 18 as discussed above. Further, Walters teaches the container assembly discussed above wherein:
the septum member 64/54/55 comprises a septum 54 hermetically closing the vessel (Fig. 9 and [0062]: “Septum 54…is formed of an elastomer rubber material sized to fit within the interior of fitment 58F thereby sealing liquid contained within pouch body…”), as in Claim 24.
Regarding Claim 25, the prior art meets the limitations of Claim 20 as discussed above. Further, Walters teaches the container assembly discussed above wherein:
the septum maintaining portion 64R-lower comprises an upper portion (said upper portion being the lower lip portion of 64R-lower, as seen through Fig. 10) arranged in the septum support 64R-lower,
and an upper maintaining piece 55 (“cap 55”), the septum being maintained between the upper portion and the upper maintaining piece 55 (Fig. 10 and [0062]: “…the lower set of ridges 64R is provided for sealing septum 54 onto fitment 64 using cap 55.”), as in Claim 25.
Regarding Claim 27, the prior art meets the limitations of Claim 18 as discussed above. Further, Walters teaches the container assembly discussed above wherein:
the vessel comprises a fluid ([0061]: “…containers 44 and 45 are designed to store solution contained within special collapsible plastic-metal-plastic pouches 63…” and “…solution contained within special collapsible plastic-metal-plastic pouches 63…”), as in Claim 27.
Regarding Claim 28, the prior art meets the limitations of Claim 27 as discussed above. Further, Walters teaches the container assembly discussed above wherein:
the fluid comprises a chemistry assay fluid (Fig. 2 and [0043]: “…bottle-like containers 43 provide bulk storage and supply of cuvette wash solution and sample and reagent probe cleaning solutions.”), as in Claim 28.
Regarding Claim 30, the prior art meets the limitations of Claim 29 as discussed above. Further, Walters teaches the container device discussed above wherein:
a fluid output port member and a needle 62N arranged to perforate the septum 54 to put in fluid communication an interior of the vessel with the fluid output port member 47 (Fig. 3 and [0045]: “…gravity feed of solutions through manifold 47…” -- Fig. 6 and [0058]: “…septum 54 is pierced by needle 62N.”), as in Claim 30.
Regarding Claim 32, the prior art meets the limitations of Claim 18 as discussed above. Further, Walters teaches the container device discussed above wherein:
the second container 62M comprises an abutment 62K arranged to abut a first portion 60 of the container assembly ([0058]: “…a mating key 62K having a pattern of closed and open sections that match only one of a number of corresponding keyed patterns notched in fin 60 in a number of corresponding keyed patterns, each pattern keyed for a selected solution…”), as in Claim 32.
Regarding Claim 33, Walters teaches a method of delivering fluid from a fluid container device, the method comprising: providing a container assembly comprising:
a first container 44 (“shelf-like thermoformed containers 44”) having a first opening 73 (Fig. 14);
a vessel 63 (“pouch 63”) having a second opening 63M (Fig. 4),
the vessel 63 being mounted within the first container 44 such that the first opening 73 and the second opening 63M are in alignment (Fig. 13 and [0064]: “…first tray section 70 and second tray section 71 are folded together to form a sealed and closed inner shell suitable for holding and protecting a single pouch 63…” – Fig. 13 further demonstrates that when the pouch 63 and vessel 44 are assembled, the first opening 73 and the second opening 63M are in alignment.);
the vessel 63 comprising a fluid ([0061]: “…containers 44 and 45 are designed to store solution contained within special collapsible plastic-metal-plastic pouches 63…” and “…solution contained within special collapsible plastic-metal-plastic pouches 63…”);
a septum member 64/54/55 mounted to the first and second openings 73/63M (Fig. 13 shows that septum 54 is mounted to the first and second openings 73 and 63M respectively.),
providing a receiving structure 62M having a fluid output port member and a needle 62N (Fig. 6 and [0058]: “…placing bottle containers 44 into appropriate mounting brackets 62M.” -- Fig. 3 and [0045]: “…gravity feed of solutions through manifold 47…” -- Fig. 6 and [0058]: “…septum 54 is pierced by needle 62N.”);
placing the container assembly in the receiving structure and perforating the septum member by the needle in order to put in fluid communication an interior of the vessel with the fluid output port member 47 ([0043]: “Bottle-like containers 43, 44 comprise a series of features that ensure that the appropriate solution bottle is correctly placed into the corresponding location.” – [0058]: “…septum 54 is pierced by needle 62N…” -- [0045]: “…gravity feed of solutions through manifold 47…”),
wherein the first container comprises at least one wall surrounding the vessel (See Fig. 11C showing a wall (continuous sidewall of the hard-shelled container device) for clamping around and thereby surrounding the vessel.),
as in Claim 33.
Further regarding Claim 33, Walters does not specifically teach the method discussed above including providing a second container having an internal housing, said container assembly being placed inside said internal housing of the second container such that said container assembly is entirely contained within the second container, and wherein the second container includes an introduction opening for the introduction of the container assembly inside its housing and a rear end part arranged to close hermetically, in a reversible manner, the introduction opening, as in Claim 33.
However, Pomeroy teaches an outer storage chamber 30 (the second container) having a gas inlet valve, and containing reagent pouches 48, wherein pumping pressurized gas into said storage chamber 30 causes liquid to flow out of said pouches 48 (Col. 7, line 15: “A reagent storage chamber 30…contains numerous pouches 48 prefilled with reagents 52. An air pump 18 is positioned beside or under the storage chamber 30 and is connected with the inside of the chamber 30 by connecting metal tubing 17 of which outlet 19 is positioned inside of the chamber 30. The air pump 18 pressurizes the chamber 30 with adequate positive pressure in pounds of air per square inch of sufficient force (psi) to squeeze the reagent pouch 48 to force the reagent 52 through the tubing 42 to enter the reaction chamber 28. Further, Pomeroy teaches the container assemblies/reagent pouches 48 as being substantially entirely contained within the storage chamber 30 (See Fig. 2 showing the pouches 48 with reagents 52 inside the sealed pressure-controlled box, and Fig. 6 showing the storage chamber 30 sealed by the lid 46. Therein, this arrangement provides a sealed environment for pressure to be altered by gas added or removed via the gas pressure lines as seen in Fig. 2. Further, Pomeroy teaches wherein the second container 30 includes an introduction opening for the introduction of a reagent pouch inside its housing (See Fig. 6 showing the reagent container having an upper introduction opening for receiving the reagent pouches 48. – See also col. 6, lines 62-65: “A reagent storage chamber 30 has a lid 46 (FIG. 3) which allows opening the chamber 30 to refill the reagent holding pouches 48 with reagent 52.”) and a rear end part 46/31 arranged to close hermetically, in a reversible manner, the introduction opening (See Fig. 6 showing the reagent container having an upper introduction opening which is covered by the lid 46 and hermetically sealed by the seal 31. – See also col. 7, lines 17-21: “The preferred embodiment of the reagent storage chamber 30 has a lid 46 which allows the chamber 30 to be completely sealed to allow the containment and pressurization of air within the reagent storage chamber 30.”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method taught by Walters to include providing a second container having an internal housing, said container assembly being placed inside said internal housing, wherein the second container comprises a gas pressurized input port in fluid communication with, a first space between an exterior of the vessel and an interior of the first container, and a second space between the exterior of the first container and an interior of the second container, such as suggested by Pomeroy, so as to induce a tunable, active flow out of the pouches and into a device at-hand., such as suggested by Pomeroy, so as to induce a tunable, active flow out of the pouches and into a device at-hand, and wherein said container assembly is substantially entirely contained within the internal housing of the second container, as seen in Pomeroy, so as to enable the sought pressure-based fluid actuation in Pomeroy only possible in a sealed container, and further wherein the second container includes an introduction opening for the introduction of the container assembly inside its housing and a rear end part arranged to close hermetically, in a reversible manner, the introduction opening, such as suggested by Pomeroy, so as to provide the architecture of Pomeroy needed for achieving the desired pressure-based actuation of replaceable reagent fluid pouches, providing an opening for replacement of the reagent units, and a sealable lid to preserve the pressurization function of liquid actuation in Pomeroy when implemented in Walters.
Further, it is noted that as the container assemblies are placed in a receiving structure in Walters, and that the containers of Pomeroy are commonly housed in a second container, the obvious combination of Walters and Pomeroy provides for the receiving structures as being in the second container for accepting the containers placed therein and pierced by the needle.
Further regarding Claim 33, Walters does not specifically teach the container device discussed above wherein the wall comprises one or several holes(s) whose number, size and distribution are configured to put the first space in fluid communication with the second space, as in Claim 33.
However, Trump teaches a respective fluid container device wherein a rigid outer bottle contains a thin and flexible inner bag that is filled with a liquid reagent. Walters further teaches that the inner bag collapses when emptied and thus provides a through hole to the rigid outer bottle for pressure equalization to allow the inner bag to easily collapse ([0067]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container assembly taught by Walters with at least one through hole provided to the first/outer container, such as taught by Trump, so as to allow pressure equalization when the bag collapses as reagent contained therein is used up, thus allowing said bag to easily collapse without negative pressure interference.
Further regarding Claim 33, the recitation “wherein the container assembly is a single-use container assembly, removable from the second container, and the second container is reusable” is drawn to an intended use limitation not holding particular patentable weight. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). When an apparatus is claimed, its patentability is based on the structure of the apparatus and not on the function it performs or the field in which it is applied. In this case, whether the container assembly is intended to be used only once while the second container is reusable is immaterial, as the structure of the respective containers and their respective functions of protecting a reagent pouch and pressurizing the pouch to dispense its contents remain the same. No structural or functional limitations are imparted by the recitation, thus it is not given weight herein and is thereby not required of the prior art.
Further regarding Claim 33, Walters does not specifically teach the container assembly discussed above wherein the second container comprises a gas pressurized input port in fluid communication with, a first space between an exterior of the vessel and an interior of the first container, and a second space between the exterior of the first container and an interior of the second container, as in Claim 33.
However, Wrench teaches a respective container device wherein an internal fluid bag 102 is contained within a rigid outer shell 110, and wherein said rigid outer shell 110 comprises a gas pressurized input port 108 (“gas interface port 108”) in fluid communication with, a first space 104 (“interstitial volume 104”) between an exterior of the vessel 102 and an interior of the first container 110. Wrench further teaches a second container 114 into which the rigid outer shell 110 is inserted, wherein a pressurized gas input port 118 connects a second space between the exterior of the first container and an interior of the second container 114 (Figs. 1 and 2 and [0053]: “The interstitial volume can be fluidity connected to a fluid interface port, which can provide a flow path for the fluid medium in the interstitial volume to enter into an instrument. As pressurized gas fills the gas bag, the volume of the interstitial volume is reduced, thereby pushing fluid medium in the interstitial volume out through the egress of the fluid interface port.”).
Walters teaches passive gravity-driven flow of reagents while Wrench conversely teaches active pressure-driven flow, wherein pressure-driven flow is more controllable and reproducible than gravity-driven flow, which may be more easily affected by viscosity or interrupted by blockages in the fluidic elements of a system.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container device of Walters with a pressurized gas inlet port, such as taught by Wrench, so as to provide a sufficient structure to induce an active and controllable liquid reagent flow from a flexible internal bag contained within a rigid housing to provide liquid reagents to a fluid handling and/or analysis apparatus.
Regarding Claim 34, the prior art meets the limitations of Claim 33 as discussed above. Further, Walters/Pomeroy teaches the method discussed above wherein:
the receiving structure is the second container 62N, and the needle projects into the interior of the second container (Fig. 6 shows second container 62N as the receiving structure. – Further, as the inclusion of the second container of Pomeroy in Walters maintains the needle 62N of Walters inside the second chamber so as to remain capable of accepting reagent pouches, as is achieved by a similar needle system on Pomeroy, the needle of Walters would thereby also be in the second container of Pomeroy so as to maintain its function of accepting a reagent pouch, and thereby would project into the interior of the second container.), as in Claim 34.
Regarding Claim 36, the prior art meets the limitations of Claim 33 as discussed above. Further, Walters teaches the method discussed above wherein:
the fluid comprises chemistry assay fluid (Fig. 2 and [0043]: “…bottle-like containers 43 provide bulk storage and supply of cuvette wash solution and sample and reagent probe cleaning solutions.”), as in Claim 36.
Regarding Claim 41, the prior art meets the limitations of Claim 33 as discussed above. Further, Walters teaches the container device discussed above wherein when the vessel is substantially empty or when replacement is needed, the container assembly is removed and replaced by another equivalent container assembly ([See [0006] discussing the “consumable” and [0045] discussing removal and replacement of the consumable when empty.), as in Claim 41.
Further as in Claim 41, when combined with Pomeroy as in Claim 33, the receiving structure remains stationary in the second container, as it commensurately remains mounted and stationary in Walters, and the container assembly would be removed and replaced from said second container.
Further as in Claim 41, the recitation “when the vessel is substantially empty or when replacement is needed, the container assembly is removed from the second container and replace” is drawn to a conditional process recitation (depending on the “when” condition to be true) that is both not necessitated by the claim and, as the claims are drawn to a device, such process recitation is not afforded patentable weight. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Walters in view of Pomeroy and Wrench, as applied to Claims 18-25, 27-28, 30, 32-34, 36, and 41 above, and in further view of Trump et al. (US2016/0296936A1), referred to hereinafter as “Trump.”
Regarding Claim 35, the prior art meets the limitations of Claim 33 as discussed above. Further, Walters teaches the method discussed above wherein:
the receiving structure is a second container 62M comprising an internal housing receiving the first container 44 (Fig. 6 and [0058]: “…placing bottle containers 44 into appropriate mounting brackets 62M.”), and
the first container comprises 44 a wall surrounding the vessel 63 (Fig. 13 and [0061]: “…containers 44 and 45 can be opened in order to place pouch 63 therein and subsequently closed and sealed in order to protect pouch 63 and allow said pouch 63 to be installed within into the appropriate mounting bracket…”), as in Claim 35.
Walters does not teach the method discussed above comprising providing at least one hole in said wall in fluid communication with the first space, between the exterior of the vessel and the interior of the first container; nor providing the second space, between the exterior of the first container and the interior of the second container, wherein said method comprises the injection of a gas through the gas pressurized input port causing the egress of the fluid from the vessel, as in Claim 35.
However, regarding the at least one hole in a wall of the first container in fluid communication with a first space, between the exterior of the vessel and the interior of the first container, and a second space, between the exterior of the first container and the interior of the second container, Trump teaches a respective fluid container device wherein a rigid outer bottle contains a thin and flexible inner bag that is filled with a reagent. Walters further teaches that the inner bag collapses when emptied and thus provides a through hole to the rigid outer bottle for pressure equalization to allow the inner bag to easily collapse ([0067]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container assembly taught by Walters with at least one hole provided to the first/outer container, such as taught by Trump, so as to allow pressure equalization when the bag collapses as reagent contained therein is used up, thus allowing said bag to easily collapse without negative pressure interference.
Further, the hole taught by Trump allows this method to be used with the rigid containers of Walters as said hole allows air to pass through the first container and into the interstitial space between said first container and the vessel so as to apply pressure to squeeze fluid out of the vessel.
Further as in Claim 35, regarding the second container comprising a gas pressurized input port in fluid communication with the first space and the second space, and wherein said method comprises the injection of a gas through the gas pressurized input port causing the egress of the fluid from the vessel, Pomeroy teaches an outer storage chamber 30 having a gas inlet valve, and containing reagent pouches 48, wherein pumping pressurized gas into said storage chamber 30 causes liquid to flow out of said pouches 48 (Col. 7, line 15: “A reagent storage chamber 30…contains numerous pouches 48 prefilled with reagents 52. An air pump 18 is positioned beside or under the storage chamber 30 and is connected with the inside of the chamber 30 by connecting metal tubing 17 of which outlet 19 is positioned inside of the chamber 30. The air pump 18 pressurizes the chamber 30 with adequate positive pressure in pounds of air per square inch of sufficient force (psi) to squeeze the reagent pouch 48 to force the reagent 52 through the tubing 42 to enter the reaction chamber 28.”)
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method taught by Walters to include providing a second container to enclose the inner pouches, and to apply pressurized gas to said second container such as taught by Pomeroy so as to induce a tunable, active flow out of the pouches and into a device at-hand.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Walters in view of Pomeroy, Wrench, and Trump.
Regarding Claim 37, Walters teaches a fluid container device for delivering fluid from a vessel, said fluid container device comprising a container assembly, said container assembly comprising:
a first container 44 (“shelf-like thermoformed containers 44”) having a first opening 73 (Fig. 14);
a vessel 63 (“pouch 63”) having a second opening 63M (Fig. 4),
the vessel 63 being mounted within the first container 44 such that the first opening 73 and the second opening 63M are in alignment (Fig. 13 and [0064]: “…first tray section 70 and second tray section 71 are folded together to form a sealed and closed inner shell suitable for holding and protecting a single pouch 63…” – Fig. 13 further demonstrates that when the pouch 63 and vessel 44 are assembled, the first opening 73 and the second opening 63M are in alignment.);
a septum member 64/54/55 mounted to the first and second openings 73/63M (Fig. 13 shows that septum 54 is mounted to the first and second openings 73 and 63M respectively.)
and wherein the first container 44 comprises a wall surrounding the vessel (the side walls of the container 44),
the container assembly includes a rear part and a front part, the first portion of the container assembly is supported by its front part (See Fig. 11C showing the front and rear parts/hemispheres each of which supporting the first portion.),
a needle 62N arranged to perforate the septum to put in fluid communication an interior of the vessel with the fluid output port member (Fig. 3 and [0045]: “…gravity feed of solutions through manifold 47…” -- Fig. 6 and [0058]: “…septum 54 is pierced by needle 62N.”)
as in Claim 37.
Further regarding Claim 37, Walters does not specifically teach the container assembly discussed above wherein said device comprises a second container, said second container having an internal housing and is arranged in order to receive said container assembly inside its internal housing, said container assembly being entirely contained within the second container and wherein the second container includes an introduction opening for the introduction of the container assembly inside its housing and a rear end part arranged to close hermetically, in a reversible manner, the introduction opening; and wherein the second container includes an abutment arranged to abut a first portion of the container assembly, and wherein the second container includes a fluid output port member and a needle arranged to perforate the septum to put in fluid communication an interior of the vessel with the fluid output port member, the needle projecting into the interior of the second container, as in Claim 37.
However, Pomeroy teaches an outer storage chamber 30 (the second container) having a gas inlet valve, and containing reagent pouches 48, wherein pumping pressurized gas into said storage chamber 30 causes liquid to flow out of said pouches 48 (Col. 7, line 15: “A reagent storage chamber 30…contains numerous pouches 48 prefilled with reagents 52. An air pump 18 is positioned beside or under the storage chamber 30 and is connected with the inside of the chamber 30 by connecting metal tubing 17 of which outlet 19 is positioned inside of the chamber 30. The air pump 18 pressurizes the chamber 30 with adequate positive pressure in pounds of air per square inch of sufficient force (psi) to squeeze the reagent pouch 48 to force the reagent 52 through the tubing 42 to enter the reaction chamber 28.”). Further, Pomeroy teaches the container assemblies/reagent pouches 48 as being substantially entirely contained within the storage chamber 30 (See Fig. 2 showing the pouches 48 with reagents 52 inside the sealed pressure-controlled box, and Fig. 6 showing the storage chamber 30 sealed by the lid 46. Therein, this arrangement provides a sealed environment for pressure to be altered by gas added or removed via the gas pressure lines as seen in Fig. 2. Further, Pomeroy teaches wherein the second container 30 includes an introduction opening for the introduction of a reagent pouch inside its housing (See Fig. 6 showing the reagent container having an upper introduction opening for receiving the reagent pouches 48. – See also col. 6, lines 62-65: “A reagent storage chamber 30 has a lid 46 (FIG. 3) which allows opening the chamber 30 to refill the reagent holding pouches 48 with reagent 52.”) and a rear end part 46/31 arranged to close hermetically, in a reversible manner, the introduction opening (See Fig. 6 showing the reagent container having an upper introduction opening which is covered by the lid 46 and hermetically sealed by the seal 31. – See also col. 7, lines 17-21: “The preferred embodiment of the reagent storage chamber 30 has a lid 46 which allows the chamber 30 to be completely sealed to allow the containment and pressurization of air within the reagent storage chamber 30.”), and wherein the second container includes an abutment arranged to abut a first portion of the container assembly (See Fig. 6 showing the frame 50 which abuts the reagent pouch 48. Further, Walters teaches an abutting element for accepting a reagent pouch in a hard shell (See Walters Fig. 6.) wherein such abutting elements are necessary and obvious as the container assembly must necessarily rest/abut against some kind of surface within the second chamber as said container assembly would not merely float in the air.).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the assembly taught by Walters wherein said device comprises a second container having an internal housing, said container assembly being placed inside said internal housing of the second container, and wherein the second container comprises a gas pressurized input port in fluid communication with, a first space between an exterior of the vessel and an interior of the first container, and a second space between the exterior of the first container and an interior of the second container, such as suggested by Pomeroy, so as to induce a tunable, active flow out of the pouches and into a device at-hand, and wherein said container assembly is substantially entirely contained within the internal housing of the second container, as seen in Pomeroy, so as to enable the sought pressure-based fluid actuation in Pomeroy only possible in a sealed container and further wherein the second container includes an introduction opening for the introduction of the container assembly inside its housing and a rear end part arranged to close hermetically, in a reversible manner, the introduction opening, such as suggested by Pomeroy, so as to provide the architecture of Pomeroy needed for achieving the desired pressure-based actuation of replaceable reagent fluid pouches, providing an opening for replacement of the reagent units, and a sealable lid to preserve the pressurization function of liquid actuation in Pomeroy when implemented in Walters, and wherein the second container includes an abutment arranged to abut a first portion of the container assembly as such abutting elements are necessary and obvious as the container assembly must necessarily rest/abut against some kind of surface within the second chamber as said container assembly would not merely float in the air.
Further, regarding the front part of the container assembly facing a front part of the second container, when the second container of Pomeroy is implemented with the container assembly of Walters, walls of the containers face one another, including the front part of the container assembly facing a front part of the second container, as the container assembly is placed within the second container. Further, when the second container of Pomeroy is implemented with Walters, the second container would contain the receiving needle 62N seen in Walters Fig. 6, which would project into the interior of the second container.
Further regarding Claim 37, Walters does not specifically teach the container assembly discussed above wherein the second container comprises a gas pressurized input port in fluid communication with, a first space between an exterior of the vessel and an interior of the first container, and a second space between the exterior of the first container and an interior of the second container, as in Claim 37.
However, Wrench teaches a respective container device wherein an internal fluid bag 102 is contained within a rigid outer shell 110, and wherein said rigid outer shell 110 comprises a gas pressurized input port 108 (“gas interface port 108”) in fluid communication with, a first space 104 (“interstitial volume 104”) between an exterior of the vessel 102 and an interior of the first container 110. Wrench further teaches a second container 114 into which the rigid outer shell 110 is inserted, wherein a pressurized gas input port 118 connects a second space between the exterior of the first container and an interior of the second container 114 (Figs. 1 and 2 and [0053]: “The interstitial volume can be fluidity connected to a fluid interface port, which can provide a flow path for the fluid medium in the interstitial volume to enter into an instrument. As pressurized gas fills the gas bag, the volume of the interstitial volume is reduced, thereby pushing fluid medium in the interstitial volume out through the egress of the fluid interface port.”). Walters teaches passive gravity-driven flow of reagents while Wrench conversely teaches active pressure-driven flow, wherein pressure-driven flow is more controllable and reproducible than gravity-driven flow, which may be more easily affected by viscosity or interrupted by blockages in the fluidic elements of a system.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container device of Walters with a pressurized gas inlet port, such as taught by Wrench, so as to provide a sufficient structure to induce an active and controllable liquid reagent flow from a flexible internal bag contained within a rigid housing to provide liquid reagents to a fluid handling and/or analysis apparatus.
Further regarding Claim 37, Walters does not teach the container assembly discussed above further comprising through hole(s) whose number, size and distribution are configured to put the first space in fluid communication with the second space, as in Claim 37.
However, Trump teaches a respective fluid container device wherein a rigid outer bottle contains a thin and flexible inner bag that is filled with a liquid reagent. Walters further teaches that the inner bag collapses when emptied and thus provides a through hole to the rigid outer bottle for pressure equalization to allow the inner bag to easily collapse ([0067]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container assembly taught by Walters with comprising at least one hole in fluid communication with the first space, between the exterior of the vessel and the interior of the first container, and the second space, between the exterior of the first container and the interior of the second container, such as taught by Trump, so as to allow pressure equalization when the bag collapses as reagent contained therein is used up, thus allowing said bag to easily collapse without negative pressure interference.
Further regarding Claim 37, the recitation “wherein the container assembly is a single-use container assembly, removable from the second container, and the second container is reusable” is drawn to an intended use limitation not holding particular patentable weight. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). When an apparatus is claimed, its patentability is based on the structure of the apparatus and not on the function it performs or the field in which it is applied. In this case, whether the container assembly is intended to be used only once while the second container is reusable is immaterial, as the structure of the respective containers and their respective functions of protecting a reagent pouch and pressurizing the pouch to dispense its contents remain the same. No structural or functional limitations are imparted by the recitation; thus, it is not given weight herein and is thereby not required of the prior art.
Claim 38, as best understood, is rejected under 35 U.S.C. 103 as being unpatentable over Walters in view of Pomeroy and Wrench, as applied to Claims 18-25, 27-28, 30, 32-34, and 36, and 41 above, and in further view of Malin et al. (US PAT 6,468,732 B1), referred to hereinafter as “Malin”.
Regarding Claim 38, the prior art meets the limitations of Claim 37 as discussed above. Further, Walters/Pomeroy does not specifically teach the container assembly discussed above wherein the first container is a cardboard box, as in Claim 38.
However, Malin teaches a respective fluid handling system wherein reagents are provided to the system by way of interface with a flexible bag/pouch, wherein said bag/pouch is contained within a cardboard box to contain and support the bag/pouch ()
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the assembly of Walters/Pomeroy such that the first container is a cardboard box, such as suggested by Malin, so as to provide a sufficient structure for containing and supported the bag therein, wherein cardboard additionally offers the benefit of recyclability and breaks down faster than plastic, as would be appreciated by one having ordinary skill in the art; and would have a reasonable expectation of success therein.
Claims 39-40, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Walters in view of Pomeroy and Wrench, as applied to Claims 18-25, 27-28, 30, 32-34, 36, and 41 above, and in further view of Hovinen et al. (US 2013/0056112 A1), hereinafter “Hovinen”, and as seen through Entegris (NOWPak® Liner Based Systems), hereinafter “Entegris”.
Regarding Claims 39-40, the prior art meets the limitations of Claims 18 and 33 as discussed above. Further, Walters/Pomeroy/Wrench does not specifically teach the device/method discussed above wherein the second container is a plastic bottle, as in Claims 39-40.
However, Hovinen teaches a respective liner-based liquid storage and dispensing assembly (Abstract) wherein a second container/airtight container 202 is provided as a sealed plastic bottle (See Fig. 8 and [0118]: “A vessel of the type commercially available from ATMI, Inc. (Danbury, Conn., USA) under the trademark NOWPAK, having a 4-liter liquid medium capacity, and a 3-port probe design, is illustratively shown.” – Note that NOWPak bottle secondary containers are made from HDPE, a thermoplastic material.). Therein, this material and bottle shape represent a mere obvious alternative to that of Walters/Pomeroy/Wrench wherein Pomeroy provides for a rectangular-shaped second container, achieving the identical function of maintaining a seal for pressure control as in Pomeroy.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Walters/Pomeroy/Wrench wherein the second container is a plastic bottle, such as suggested by Hovinen, as a mere obvious alternative to that of Walters/Pomeroy/Wrench wherein Pomeroy provides for a rectangular-shaped container, achieving the identical function of maintaining a seal for pressure control as in Pomeroy.
Response to Arguments
35 USC 112
Applicant’s amendments sufficiently overcome those rejections set forth by the prior office action under 35 USC 112. As such, those rejections under 35 USC 112 are withdrawn herein. Note that a new grounds of indefiniteness under 35 USC 112 is set forth over Claim 41, as necessitated by Applicant’s addition of the new claim.
35 USC 103
Applicant’s arguments are on the alleged grounds that none of the previously applied prior art references teaches Applicant’s amendments further specifying the disposable nature of the container assembly and the reusable nature of the second container, while also structurally defining the dual-layer system on the basis of the first and second spaces to be pressurized.
Applicant’s arguments are not persuasive because each and every element of the claims including Applicant’s amended claim language remains taught by the combination of prior art references previously set forth. The second container having a sealable opening for pressurizing and actuating fluids in a pouch is covered by Pomeroy, the hole providing fluidic communication between the first and second spaces is covered by Trump, and the ancillary details of the walls/portions of the container assembly are covered by Walters. – See above in the body of the action regarding the specific explanations of the prior art elements coinciding with those claimed.
Further, Applicant’s assertion that the claimed device is for “single use” is drawn to an intended use recitation. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). When an apparatus is claimed, its patentability is based on the structure of the apparatus and not on the function it performs or the field in which it is applied. Herein, the prior art device is fully capable of being used once and discarded or left to not be used after a first use. Whether the prior art is to be used once or not is immaterial as the structure of container within container and its function of delivering reagent liquid remain the same.
Thus, Examiner sets forth the rejection of independent Claims 18 and 33 as unpatentable under 35 USC 103 over Walters in view of Pomeroy, Wrench, and Trump; and Examiner maintains the rejection of independent Claim 37 under 35 USC 103 over Walters in view of Pomeroy, Wrench, and Trump, the modifications to each rejection being necessitated by Applicant’s amendments.
New Claim 41
Claim 41 is rejected under 35 USC 103 as being unpatentable over Walters in view of Pomeroy, Wrench, and Trump, Walters providing the removal and replacement aspect, and Pomeroy providing the second container. Further, Claim 41 is predicated on the conditional “when the vessel is substantially empty or when replacement is needed” which is not particularly necessitated by the claim. Claim 41 and Claim 33 on which it depends lack any discussion to filling or emptying the vessel, nor detection of when a particular fluid level has been reached. As such, the conditional depending on emptying the vessel does not hold particular patentable weight.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi, can be reached at telephone number (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center; and visit https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you need assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
Prosecution Insights