My 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/08/2025 has been entered.
Remarks
This office action fully acknowledges Applicant’s arguments and amendments filed 08 August 2025.
Claims 18-28, 30, and 32-40 are pending.
Claims 1-17, 29, and 31 are cancelled.
No claims are withdrawn.
Claims 39 and 40 are newly added.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claims 18, 33, and 37 recite that the “container assembly is substantially entirely contained within the internal housing of the second container”, however, this language, specifically the utilization of the phrase “substantially entirely” is not present within Applicant’s instant specification.
The amendment filed 08/08/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Claims 18, 33, and 37 recite that the “container assembly is substantially entirely contained within the internal housing of the second container”, however, this language this language, specifically the utilization of the phrase “substantially entirely” is not present within Applicant’s instant specification, instead merely discussing the first container being “placed inside” the second container. Further, it appears this “substantially entirely contained” languages arises from the disclosure of Fig. 3 showing the container assembly 20 as within the second container 150; however, the figure 3 shows full containment of the container assembly even in the portion in Fig. 4 showing the protruding septum member 50 and maintaining piece 78 as contained within the bounds of the second container 150 via the protruding male screw elements.
Further, the second container is discussed in Applicant’s disclosure as including the port member 170 (serving as a cap sealing the first container fully within the second container) given the Claim 30 discussion of the second container including the needle and output port: “the second container comprises a fluid output port member and a needle”. As such, these elements serve to fully enclose the fluid container assembly already residing completely within the bounds of the second container. Thus, no such provision requiring that the “container assembly is substantially entirely contained within the internal housing of the second container” is supported by the disclosure, absent evidence to the contrary.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 18-28, 30, and 32-40 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.
The amended recitation of “...wherein said device comprises a second container having an internal housing arranged in order that when said container assembly is placed inside said internal housing of the second container, said container assembly is substantially entirely contained within the internal housing of the second container”, specifically wherein the container assembly “substantially entirely contained within the second container”, is drawn to subject matter which was not described in the disclosure at the time of filing and is thereby asserted as being a new matter situation herein.
Initially, Applicant’s instant specification does not utilize the language “substantially entirely contained within…” Further, and from the disclosure, the container assembly is entirely contained within the second container given the para. [0065] discussion to the fluid output port member as part of the second container, the para. [0104] discussion of sealing of the second container (plastic bottle in this case) with the fluid output port member, and Fig. 4 showing the fluid output port member 170 and second container 150 thereof as completely enclosing the container assembly 20.
Thus, no such provision requiring that the “container assembly is substantially entirely contained within the internal housing of the second container” is supported by the disclosure, which includes the drawings.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 18-28, 30, and 32-40 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 Claims 18 and 37, the claims recite “said container assembly comprising:...” followed by recitations to the second container, wherein the second container is drawn to a separate element from the container assembly.
Herein, it does not appear that the second container is intended as part of the container assembly given the container assembly recited as being placed within the second container. Applicant may wish to recite the second container in isolation prior to the container assembly.
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, and 36, 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”, and Wrench et al. (US 2014/0261868 A1), referred to hereinafter as “Wrench”.
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.), as in Claim 18.
Further regarding Claim 18, Walters does not specifically teach the container assembly discussed above wherein said device comprises a second container having an internal housing arranged in order that when said container assembly is placed inside said internal housing of the second container, said container assembly is substantially entirely contained within the internal housing of the second container, 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 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.
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, 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.
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.
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:
the second container comprises 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 29 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…”), 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 substantially entirely contained within the internal housing of the second container, 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.
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.
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 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 teaches the method discussed above wherein:
the receiving structure is the second container 62M (Fig. 6 shows second container 62M as the receiving structure.), 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.
Claims 26 and 35, 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, and 36-37 above, and in further view of Trump et al. (US2016/0296936A1), referred to hereinafter as “Trump.”
Regarding Claim 26, the prior art meets the limitations of Claim 18 as discussed above. Further, Walters teaches the container assembly discussed above wherein:
the first container 43 comprises at least one 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 26.
Further regarding Claim 26, Walters does not teach the container assembly discussed above wherein the wall comprises at least one hole, as in Claim 26.
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.
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, 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, as best understood, is rejected under 35 U.S.C. 103 as being unpatentable over Walters in view of Pomeroy, Wrench, and Trump, as applied to Claims 26 and 35 above.
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),
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 having an internal housing, said container assembly being placed inside said internal housing of the second container, wherein when said container assembly is placed inside said internal housing of the second container, said container assembly is substantially entirely contained within the housing 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.
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.
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 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, 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.
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 36-37 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, and 36-37 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
Claim Rejections – 35 USC 103
Applicant’s arguments are on the grounds that Walters allegedly does not disclose the container assembly placed inside the internal housing of a second container, and that this deficiency in Walters is allegedly not cured by obvious modification inspired by Pomeroy as Pomeroy teaches a single layer outer storage chamber and not a dual layer system such as in the instant Claim 18.
Applicant’s arguments are not persuasive because the “a first container” of Applicant’s instant claims is provided for by the prior art of Walters for protecting the inner pouch from damage ([0061]), wherein the secondary container of Pomeroy is utilized in modifying Walters as an obvious method of pressure-fluid control, not merely protection. As such, the “first containers” of Walters would remain present so as to serve the function of protecting the flexible vessel stored inside. Thus, Pomeroy is not relied upon for providing a dual layer system, but rather a dual layer system is the result of the modification of Walters with Pomeroy as discussed.
Applicant further argues that the first containers of Walters would not be usable with the second container pressure-flow system of Pomeroy as the containers of Walters are sealed, thereby not satisfying the hole permitting fluid communication between the volume of the second container and the space between the flexible vessel and the first container.
Applicant’s arguments are not persuasive because, upon further consideration, the first containers of Walters, while discussed in Walters as being “sealed”, are not themselves airtight after such sealing, instead comprising necessary holes allowing airflow when reagent is removed from the pouch. Walters para. [0063] teaches that said sealing of the first container is achieved by spot welding, thereby not fully joining the circumferential edges of the first container clamshell; and para. [0064] discusses the clam-shell-like first containers as formed from polystyrene, which itself is an air-permeable material and not capable of forming an airtight seal. Thus, as the sealing process involves mere spot welding, the gaps between the spot welds satisfy the “at least one hole” of Claims 26, 35, and 37 (The term “hole” herein is given the broadest reasonable interpretation as being “an opening or empty space in a material”.). Further, as polystyrene is a porous material, it is reasonable to assert that the “wall surrounding the vessel” comprises “at least one hole” by mere composition of the material alone having numerous small holes. Further, Walters makes no mention of forming an airtight seal through the first container, and Examiner asserts that such an airtight seal would render the device of Walters inoperable as fluid volume removed from the pouches would not be able to be replaced by air volume, thereby preventing flow. Thus, the “at least one hole” must necessarily be present in Walters for the device to function.
Regarding the specific provision of a hole in the dependent claims and independent Claim 37, in order to best address what appears to be applicant’s intent of a symmetrical through-hole as opposed to a slit or porosity, Claims 26, 35, and 37 are rejected herein under 35 USC 103 over Walters in view of Pomeroy, Wrench, and Trump, wherein obvious modification suggested by Trump provides a pressure-equalizing hole to the first containers of Walters.
Applicant’s arguments are further on the grounds that Wrench allegedly does not teach or suggest the pouch and first container assembly substantially entirely contained within an internal housing of the second container, as in the amendments to Claim 1.
Applicant’s arguments are not persuasive because the prior art of Wrench is not relied upon for providing the container assembly and pouch as substantially entirely within the second container, wherein this limitation is instead provided for by the prior art of Pomeroy discussed above where implementation of the second container of Pomeroy would substantially entirely contain the pouch and first container of Walters. Further regarding Applicant’s statement on the fluid communication in Wrench, this limitation is provided for by the prior art of Walters/Pomeroy wherein the gas permeability provided to the first containers of Walters permits fluid communication and gas-based fluid actuation. Wrench is merely relied upon for providing a gas pressurized inlet port; the “second container” of wrench is the box cap 114 similarly placed therein/on for gas-based fluid actuation. Further, the containment is predicated upon a conditional process (“when said container is placed”) not positively necessitated by the claim.
Thus, in view of the above, Examiner respectfully maintains the rejection of Claims 18-25, 27-28, 30, 32-34, and 36-37 as unpatentable under 35 USC 103 over Walters in view of Pomeroy and Wrench.
Claim 38
Applicant’s arguments are on the grounds that Malin does not teach the Claim 37 requirements of a second container and a first container having a hole in one of its walls. Applicant further contends it would not have been obvious to use a cardboard box in Walters/Pomeroy/Wrench as it would not be resistant to pressure.
Applicant’s arguments are not persuasive because Malin is not relied on for providing the features of a second container and a first container having a hole in one of its walls, wherein these elements are provided for in Claim 37 by obvious combination of Walters providing the a first container having at least one hole in its walls, and Pomeroy providing the second container, as discussed above in the body of the action. Further, Applicant’s assertion regarding the pressure sensitivity of cardboard is not persuasive given that cardboard is not an airtight material and would be similarly assembled as discussed by Walters as maintaining gaps for airflow between spot welds.
Thus, in view of the above, Examiner respectfully maintains the rejection of Claim 38 as unpatentable under 35 USC 103 over Walters in view of Pomeroy, Wrench, and Malin.
New Claims 39 and 40
Claims 39 and 40 are rejected herein under 35 U.S.C. 103 as being unpatentable over Walters in view of Pomeroy and Wrench, and in further view of Hovinen, and as seen through Entegris. Hovinen and Entegris are newly cited herein as necessitated by Applicant’s addition of new claims.
35 USC 112b
A new indefiniteness rejection is set forth herein over the instant claim amendments requiring the “container assembly is substantially entirely contained within the housing of the second container”, wherein this rejection newly set forth herein is necessitated by Applicant’s amendments.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798