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 .
Claim Objections
The claims contain minor informalities.
In claim 7, the language “… the inlet port of the secondary container is configured to be fluidly coupled to the exudate outlet port of the primary container, and the outlet port of the secondary container is in fluid communication with a third one-way valve configured to permit fluid flow out of the second internal volume and to prevent fluid flow into the second internal volume.” should be changed for clarity.
In claim 10, the language “… wherein the fourth one-way valve is configured to permit fluid flow into the second internal volume and…” should be changed for clarity.
In claim 21, the language “… wherein the pump is configured to generate …” should be changed for clarity.
In claim 22, the language “… wherein the first port is configured to be in fluid communication with the primary container through the pressure inlet port, and the second port is configured to be in fluid communication with …” should be changed for clarity.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 26 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 pre-AIA the applicant regards as the invention.
Claim 26 calls for “A method of purging exudate from a canister, comprising … discharging exudate from the first internal volume to the second internal volume.” This language is ambiguous because the canister appears in the preamble but is never again mentioned. The claim does not explain how the process of moving exudate between the two volumes affects the canister.
The specification describes an embodiment comprising primary and secondary containers, where the primary container is analogous to a canister (¶ [0027] The container 115 is representative of a container, canister, pouch, or other storage component; ¶ [0047] The primary container 310 can be analogous to the container 115 introduced in FIG. 1 and can include a first internal volume 332 configured to collect fluid or exudate from a tissue site). This disclosure implies that the canister equates to the first internal volume. However, limitations cannot be read from the specification into the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 25 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jaeb; Jonathan et al. (US 20070260226 A1).
Regarding claim 25, Jaeb discloses a system configured to purge exudate (¶ [0003], [0008], [0017], FIG. 1, system 100 provides for the collection and disposal of wound exudate through a dressing; ¶ [0019] FIG. 2 is a schematic diagram of the wound exudate removal and isolation system 100);
comprising: a primary container including a first internal volume (¶ [0023] Again referring to FIG. 2 … a non-removable, drainable canister 8 in fluid communication with valve 3. In one embodiment, canister 8 is drainable and constructed from a rigid material);
a secondary container including a second internal volume configured to be releaseably and fluidly coupled to the first internal volume (¶ [0024], The disposable container 7 may be a flexible, vented disposal bag. When the disposable container 7 is full, it may be removed and replaced with an empty container);
a pump including a pump inlet and a pump outlet, the pump configured to generate negative pressure at the pump inlet and positive pressure at the pump outlet (¶ [0025] Reduced pressure is provided to the dressing 1.0 through the canister by a pump 11 that is fluidly connected to the canister. In one embodiment pump 11 is a battery-operated vacuum/pressure pump; ¶ [0026], In the vent position, the inlet of the pump 11 is vented. Another three-way valve 10 is fluidly connected between the canister 8 and an outlet of the pump 11. The valve 10 is selectively positionable between an active position and a vent position. In the active position, the valve 10 allows fluid communication between the canister and the outlet of the pump 11. In the vent position, the outlet of the pump 11 is vented);
a control valve fluidly coupled to both the pump inlet and the pump outlet and being selectively positionable in a therapy state or a purge state (¶ [0026], To facilitate forced drainage of the canister 8, a three-way valve 9 is fluidly connected between the canister 8 and an inlet of the pump 11 … Another three-way valve 10 is fluidly connected between the canister 8 and an outlet of the pump 11);
wherein the negative pressure at the pump inlet is in fluid communication with the first internal volume in the therapy state (¶ [0026], In the active position, the valve 9 allows fluid communication between the canister and the inlet of the pump 11 … In the vent position, the outlet of the pump 11 is vented); and
wherein the positive pressure at the pump outlet is in fluid communication with the first internal volume in the purge state (¶ [0026], In the active position, the valve 9 allows fluid communication between the canister and the inlet of the pump 11. In the vent position, the inlet of the pump 11 is vented … In the active position, the valve 10 allows fluid communication between the canister and the outlet of the pump 11 … The positioning of the valves 9, 10 is linked such that a positioning of the valve 9 in the active position results in a positioning of the valve 10 in the vent position. Similarly, a positioning of the valve 9 in the vent position results in a positioning of the valve 10 in the active position).
Regarding the control valve fluidly coupled to both the pump inlet and the pump outlet, Jaeb discloses two valves that operate in concert (¶ [0026], The positioning of the valves 9, 10 is linked such that a positioning of the valve 9 in the active position results in a positioning of the valve 10 in the vent position. Similarly, a positioning of the valve 9 in the vent position results in a positioning of the valve 10 in the active position). Jaeb’s pair of valves are analogous to the claimed control valve since they are linked and configured to act simultaneously.
Claim 26 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hopman; Lance D. et al. (US 20140171889 A1).
Regarding claim 26, Hopman discloses a method of purging exudate from a canister (¶ [0002] The present disclosure relates to devices capable of carrying out multiple functions in connection with emergency medical care; ¶ [0011], such a multi-purpose hand pump may be connected so as to pump liquids and entrained semi-solids and solid materials through the pump and into a collection bag; ¶ [0036] Yet another related system 128 is shown in FIG. 6);
comprising: providing a primary container including a first internal volume (¶ [0036], the multi-purpose hand pump 10);
providing a secondary container including a second internal volume (¶ [0036], the collection bag 132); and
discharging exudate from the first internal volume to the second internal volume (¶ [0037], Within the collection bag 132 … a one-way valve such as a flutter valve 146 in order to admit material brought into the squeeze bulb 12 and then forced on out of the squeeze bulb 12 and through the overpressure conduit 130 into the interior of the collection bag 132 during operation of the hand pump 10).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 5-8, 10-13, 15, 16 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Jaeb; Jonathan et al. (US 20070260226 A1) in view of Stanton; Kelly et al. (US 20210093243 A1).
Regarding claim 1, Jaeb discloses a canister assembly configured to purge exudate (¶ [0003], [0008], [0017], FIG. 1, system 100 provides for the collection and disposal of wound exudate through a dressing; ¶ [0019] FIG. 2 is a schematic diagram of the wound exudate removal and isolation system 100);
comprising: a primary container including an internal volume, a pressure inlet port, an exudate inlet port, and an exudate outlet port each in fluid communication with the internal volume (¶ [0023] Again referring to FIG. 2 … a non-removable, drainable canister 8 in fluid communication with valve 3. In one embodiment, canister 8 is drainable and constructed from a rigid material);
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a first one-way valve in fluid communication with the exudate inlet port and the internal volume, the first one-way valve configured to permit fluid flow into the internal volume and to restrict fluid flow out of the internal volume (¶ [0023] Again referring to FIG. 2 for illustration, a check valve 2 prevents the backflow of exudate into the wound); and
a second valve in fluid communication with the exudate outlet port and the internal volume, the second valve configured to permit fluid flow out of the internal volume and to restrict fluid flow into the internal volume (¶ [0023], A valve 4 is positioned on the disposal line 14 in fluid communication with the canister 8; ¶ [0024], In this configuration, valve 4 is closed to prevent drainage of the canister 8. To drain the canister 8, valve 3 is closed and valve 4 is opened. The closing of valve 3 prevents reduced pressure from being applied to the wound, while the opening of valve 4 allows wound exudate in the canister 8 to drain through the disposal line 14).
Jaeb does not explicitly disclose that the second valve is a one-way valve. Stanton discloses a Foley type catheter for sensing physiologic data from the bladder and/or urinary tract of a patient (¶ [0003], [0011], [0014], [0163] FIG. 10A shows an embodiment of the sensing Foley catheter; ¶ [0164] Sensing Foley catheter 1000);
comprising: a primary container including an internal volume, a pressure inlet port, a fluid inlet port, and a fluid outlet port each in fluid communication with the internal volume (¶ [0164], reservoir or cassette 1022);
a first one-way valve in fluid communication with the fluid inlet port and the internal volume, the first one-way valve configured to permit fluid flow into the internal volume and to restrict fluid flow out of the internal volume (¶ [0489] FIG. 101A shows an embodiment of the sensing Foley catheter system which includes valves at both the drainage ports 10102, and at the entry point 10104, where the drainage tubing connects to the collection vessel. This allows the controller to periodically pressurize the collection vessel which may reduce bubbles and/or aid draining of the collection vessel. This entry port valve may also result in more accurate measurements of urine output since urine flow into the collection vessel can be stopped by the controller during urine emptying); and
a second one-way valve in fluid communication with the fluid outlet port and the internal volume, the second one-way valve configured to permit fluid flow out of the internal volume and to restrict fluid flow into the internal volume (¶ [0178] Urine/fluid drainage bag 1020 includes one way valves 1136 connected to overflow tubing 1138 and outflow tubing 1140 to prevent urine/fluid from exiting the drainage bag once collected; ¶ [0489] FIG. 101A shows an embodiment of the sensing Foley catheter system which includes valves at both the drainage ports 10102, and at the entry point 10104).
Stanton simplifies the requirements for constructing a primary container that drains fluid from a patient’s wound. A skilled artisan would have been able to modify Jaeb with Stanton’s first and/or second one-way valves by replacing or supplementing Jaeb’s actively operated valve 4 with Stanton’s passive one-way valve.
Jaeb discloses that fluid passes only in one direction from the dressing to the primary container (¶ [0023], a check valve 2 prevents the backflow of exudate into the wound); and also in only one direction from the primary container to the secondary container (¶ [0024], In this configuration, valve 4 is closed to prevent drainage of the canister 8. To drain the canister 8, valve 3 is closed and valve 4 is opened; ¶ [0026] As previously described, the canister 8 may be drained by positioning valve 3 in a closed position and valve 4 in an open position). Therefore, Jaeb’s actively operated valve 4 can be replaced with a passive check valve without changing the system’s operation. Stanton’s passive check valves also always prevent backflow, instead of only when they have been manually closed.
One would be motivated to modify Jaeb with Stanton’s second one-way valve to simplify Jaeb’s system, and so that it can be constructed with less costly components. Therefore, it would have been obvious to modify Jaeb with Stanton’s second one-way valve to construct the system at lower cost and to make it more reliable.
Regarding claims 5, 6, 11-13, 15, 16 and 21-23, Jaeb discloses a canister assembly wherein the exudate inlet port is configured to be fluidly coupled to a dressing positioned at a tissue site and to receive exudate from the tissue site (¶ [0022] The reduced pressure applied to the dressing 1.0 is strong enough to continuously draw exudate from the wound through the tubing 1.2; ¶ [0023], Downstream from the push-to-open in-line valve 3 is a non-removable, drainable canister 8 in fluid communication with valve 3);
wherein the internal volume of the primary container is a first internal volume (¶ [0023], canister 8); and
wherein the canister assembly further comprises a secondary container including a second internal volume that is configured to be fluidly coupled to the first internal volume through the exudate outlet port of the primary container (¶ [0024], Optionally, a disposable container 7 may be connected to the disposal line 14 to collect the wound exudate drained from the canister 8);
wherein the secondary container is removeable from the exudate outlet port of the primary container (¶ [0024], The disposable container 7 may be a flexible, vented disposal bag);
wherein the second internal volume is greater than the first internal volume (Fig. 2, disposable container 7 is depicted as larger than canister 8);
wherein the primary container is formed of a rigid material and the secondary container is formed of a flexible material; wherein the primary container comprises walls formed of a rigid plastic and the secondary container comprises walls formed of a soft film; wherein the secondary container comprises a disposable bag (¶ [0023], In one embodiment, canister 8 is drainable and constructed from a rigid material; ¶ [0024], The disposable container 7 may be a flexible, vented disposal bag);
further comprising a pump including a pump inlet and a pump outlet, the pump configured to generate negative pressure at the pump inlet and positive pressure at the pump outlet (¶ [0025] Reduced pressure is provided to the dressing 1.0 through the canister by a pump 11 that is fluidly connected to the canister. In one embodiment pump 11 is a battery-operated vacuum/pressure pump; ¶ [0027] When valve 9 is positioned in the active position and valve 10 is positioned in the vent position, the pump 11 is configured to draw wound exudate from the dressing 1.0 into the canister 8. In this reduced pressure configuration, valve 3 is positioned in the open position and valve 4 is positioned in the closed position. When valve 9 is positioned in the vent position and valve 10 is positioned in the active position, the pump 11 is configured to provide a positive pressure to the canister);
further comprising a control valve fluidly coupled to both the pump inlet and the pump outlet and including a first port and a second port, first port configured to be in fluid communication with the primary container through the pressure inlet port, the second port configured to be in fluid communication with ambient environment (¶ [0026], To facilitate forced drainage of the canister 8, a three-way valve 9 is fluidly connected between the canister 8 and an inlet of the pump 11. The valve 9 is selectively positionable between an active position and a vent position. In the active position, the valve 9 allows fluid communication between the canister and the inlet of the pump 11. In the vent position, the inlet of the pump 11 is vented. Another three-way valve 10 is fluidly connected between the canister 8 and an outlet of the pump 11. The valve 10 is selectively positionable between an active position and a vent position);
wherein the control valve is selectively positionable in a therapy state or a purge state (¶ [0026], To facilitate forced drainage of the canister 8, a three-way valve 9 is fluidly connected between the canister 8 and an inlet of the pump 11 … Another three-way valve 10 is fluidly connected between the canister 8 and an outlet of the pump 11);
wherein the negative pressure at the pump inlet is in fluid communication with the first port and the pump outlet is in fluid communication with the second port in the therapy state (¶ [0026], In the active position, the valve 9 allows fluid communication between the canister and the inlet of the pump 11 … In the vent position, the outlet of the pump 11 is vented); and
wherein the pump inlet is in fluid communication with the second port and the positive pressure at the pump outlet is in fluid communication with the first port in the purge state (¶ [0026], In the active position, the valve 9 allows fluid communication between the canister and the inlet of the pump 11. In the vent position, the inlet of the pump 11 is vented … In the active position, the valve 10 allows fluid communication between the canister and the outlet of the pump 11 … The positioning of the valves 9, 10 is linked such that a positioning of the valve 9 in the active position results in a positioning of the valve 10 in the vent position. Similarly, a positioning of the valve 9 in the vent position results in a positioning of the valve 10 in the active position).
Regarding claim 3, Jaeb lacks a second one-way valve Stanton discloses a first one-way valve and a second one-way valve that each include a flow direction positioned opposite each other relative to the primary container (¶ [0489] FIG. 101A shows an embodiment of the sensing Foley catheter system which includes valves at both the drainage ports 10102, and at the entry point 10104).
Stanton reduces the complexity of valves in a fluid collection system. Regarding the rationale and motivation to modify Jaeb with Stanton’s check valves, see the discussion of claim 1 above.
Regarding claim 7, Jaeb discloses that the secondary container includes an inlet port and an outlet port each in fluid communication with the second internal volume, the inlet port of the secondary container configured to be fluidly coupled to the exudate outlet port of the primary container (¶ [0024], The disposable container 7 may be a flexible, vented disposal bag. When the disposable container 7 is full, it may be removed and replaced with an empty container).
Jaeb does not explicitly disclose a third one-way valve. Stanton discloses a secondary container wherein an outlet port of the secondary container in fluid communication with a third one-way valve configured to permit fluid flow out of the second internal volume and to prevent fluid flow into the second internal volume (¶ [0178], Vent 1142, which may be a hydrophobic or other vent, allows air or gas to exit the drainage bag, but does not allow fluid to exit the bag; ¶ [0412], A second vent/valve assembly 6708 is shown on the barb in FIG. 67; ¶ [0427] FIG. 78 … Vent 7804 may be anywhere along the length of positive pressure vent tube 7802. The embodiment shown in FIG. 78 may or may not include a one-way valve between the filter and the opening; ¶ [0446] FIGS. 90 and 91A and B … The vent tube may or may not include a filter or a valve; ¶ [0533] Any of the vent tube embodiments disclosed herein may additionally or alternatively be used to vent the drainage bag or the cassette. For example, bag vent 1142 shown in FIG. 10A may incorporate any of the vent tube designs).
Stanton incorporates both a filter and valve at the outlet for a collection container, which prevents liquids from leaving the container and prevents any fluids from entering the container. One would be motivated to modify Jaeb with Stanton’s third one-way valve to prevent backflow into Jaeb’s second container. Therefore, it would have been obvious to modify Jaeb with Stanton’s third one-way valve to prevent backflow into the second container.
Regarding claim 8, Jaeb further discloses a moisture barrier positioned in fluid communication with the outlet port of the secondary container (¶ [0028] A hydrophobic filter 8.1 also may be included in fluid communication with the canister 8 to prevent fluid from entering the tubing attached to pump 11 and valves 9 and 10).
Regarding claim 10, Jaeb and Stanton do not explicitly disclose a fourth one-way valve. Stanton is cited as teaching a one-way valve in fluid communication with the inlet port of the second container and the second internal volume (¶ [0178] Urine/fluid drainage bag 1020 includes one way valves 1136 connected to overflow tubing 1138 and outflow tubing 1140 to prevent urine/fluid from exiting the drainage bag once collected).
The fourth one-way valve is interpreted as a duplication of parts, which does not provide patentability unless a new and unexpected result is produced. Both the second and fourth one-way valves open in the same direction and prevent fluid from leaving the second container.
A skilled artisan would have been able to duplicate the second one-way valve by arranging two check valves in series, to prevent backflow if one of the valves fails. Therefore, a new and unexpected result would not be produced by duplicating the one-way valve. See MPEP 2144.04 (VI)(B).
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Jaeb and Stanton in view of Leclerc; Roland-Yves J. (US 4525166 A).
Regarding claims 17-19, Jaeb and Stanton lack a fluid solidifier, capillary foam or captive negative pressure. Leclerc discloses a suction drainage device comprising a fluid solidifier positioned in a second internal volume (col. 5, lines 40-45, As material 2 there may be used, instead of a suitable foam, laminaria (kelp) in granular form or incorporated in foam molded parts. Laminaria swells by absorption of liquid and does not later release the liquid);
comprising a secondary container including one or more of a wicking material, a superabsorbent material, and high suction capillary foam positioned in the second internal volume (col. 3, lines 15-20, Open-pore filling material of a spongy structure include, for example, polyurethane foams of suitable resilience; col. 5, lines 10-15, Referring first to FIGS. 1-3, a drainage device comprises a receptacle 1 in the form of a flat, flexible foil or sheet bag, or tube, or a bellows, the cavity of which is completely filled with a sorbent material 2 in the form of a thick strip of material);
wherein the secondary container includes a captive negative pressure within the second internal volume (col. 4, lines 10-25, The vacuum or suction effect … The volume of air contained within the receptacle is removed for example by folding the receptacle or rolling it up … The vacuum as well as the capillary action or the sorption properties of the filling material contained in the receptacle then respectively bring about, as the receptacle expands, a gentle removal of body fluids and their collection in the receptacle itself. If desired, the vacuum can be created by evacuating with an external vacuum source).
To clarify, Leclerc’s foam is interpreted as analogous to both the capillary foam and captive negative pressure, since these claims depend in parallel on parent claim 6. Leclerc simultaneously generates suction and sequesters fluids inside a container with a passive device that does not require electricity, and which can be activated manually. One would be motivated to modify Jaeb and Stanton with Leclerc’s capillary foam or captive negative pressure to reliably generate vacuum and to store fluids in a secondary container since Jaeb calls for a disposable plastic collection container (¶ [0024], When the disposable container 7 is full, it may be removed and replaced with an empty container). Therefore, it would have been obvious to modify Jaeb and Stanton with Leclerc’s capillary foam or captive negative pressure to meet Jaeb’s need for a flexible container.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Jaeb and Stanton in view of Maitz; Carlos A. et al. (US 5062835 A).
Regarding claim 20, Jaeb and Stanton lack a purge pump. Maitz discloses an aspirator device (col. 2, lines 35-45; col. 3, lines 55-60, aspirator device 10);
comprising a purge pump configured to be fluidly coupled to an outlet port of a secondary container, wherein the purge pump is configured to provide negative pressure to the outlet port of the secondary container (col. 4, lines 35-45, the aspirator device includes a manually operable vacuum means or squeeze bulb 30 which is connected to the fluid collector 12 through the elbow or reversely bent tube section 32 which extends between the squeeze bulb 30 and the fluid collector 12; col. 5, lines 10-15, Releasing the previously squeezed bulb imposes a reverse differential pressure which causes the resilient valve walls 54, 56 to part and thereby permit air or body fluids to be drawn through flexible tubes 18 into collector 12, and then through valve 52 and finally into bulb 30).
Maitz demonstrates how to generate vacuum with a squeeze bulb which draws fluid into a container. One would be motivated to modify Jaeb and Stanton with Maitz’s purge pump to apply further suction to the secondary container. Therefore, it would have been obvious to modify Jaeb and Stanton with Maitz’s purge pump to generate additional vacuum pressure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights