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 5, the language “… flowing the blood through the filter to [[cause filtering of]] capture solid material.” should be changed for brevity.
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.
Claims 1-3, 5 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Se, Erik et al. (US 20030144646 A1).
Regarding claim 1, Se discloses a method of capturing blood for reintroduction into a vasculature of a patient during an aspiration procedure (¶ [0001] The present invention relates to a method and an apparatus for collecting and transporting liquids … or for transferring the liquid to another liquid system; ¶ [0029] It should also be pointed out that the invention can be used post operatively, ie for collecting blood from a patient after a surgical operation);
the method comprising: providing a canister to be placed in fluid communication with the vasculature of a patient (¶ [0016], a recipient 8 in the form of a canister bag 9 disposed in a stiff casing 10);
the canister having an inlet (annotated Fig. 1 shows an inlet at “IN”; ¶ [0021] The lid 21 of the canister bag has an inlet conduit 22 from the mixer 7,);
a first outlet (annotated Fig. 1 shows a first outlet at “1st”; ¶ [0021], a suction conduit 24; ¶ [0022], The container 10 is also connected to the suction side of the vacuum pump 1, via a side hose 26 with filter 27); and
a second outlet (annotated Fig. 1 shows a second outlet at “2nd”; ¶ [0021] an outlet conduit 23 for tapping liquid … the outlet conduit 23 is extending down into the bottom part of the bag);
applying aspiration to the canister via the first outlet (¶ [0022] The suction hose 24 is connected to the suction side of the vacuum pump via a shut-off valve 25, a manometer 3 and control means 2. The container 10 is also connected to the suction side of the vacuum pump 1, via a side hose 26 with filter 27. By this means the recipient is affected by two pressure levels, a first low pressure level P1 (large suction effect) … and a second relatively higher pressure level P2 (lower suction effect));
aspirating blood from the patient and into the canister via a first tubing connected to the inlet (¶ [0026], The bag has a lid 21 welded onto the bag and provided with said inlet conduit 22 for connection to the mixer hose and a connection tube 39 for the suction hose 24; ¶ [0029], the invention can be used post operatively, ie for collecting blood from a patient after a surgical operation);
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filtering the blood collected inside the canister using a filter positioned in fluid communication between an opening of the second outlet and at least a portion of an internal space of the canister (¶ [0020] The centrifugated blood is then sucked via a filter arrangement 16, which in this case comprises a large filter 17 with a mask size of approximately 150-250 .mu.m, for separating bone residuals and other particles from the blood, and a fine filter 18 with a mask size of approximately 30-40 .mu.m, for separating coagulents, fat particles or the like, and collected in the canister bag 9 which may have a volume of about 2000 ml); and
withdrawing filtered blood from the canister via the second outlet (¶ [0016], two transfer bags 11, 12 for an automatic collection of the blood; ¶ [0027], the blood has to pass this hose before it is tapped out through the outlet hose 23).
Regarding claims 2, 3 and 5, Se discloses a method further comprising introducing the filtered blood withdrawn from the canister into the vasculature of a patient (¶ [0004] In order to solve the problem with blood supply it has been previously proposed to collect and intra operatively provide the patient with as much of his own blood as possible from the operation; ¶ [0029] It should also be pointed out that the invention can be used post operatively, ie for collecting blood from a patient after a surgical operation);
wherein applying aspiration to the canister via the first outlet comprises connecting the first outlet with an aspiration pump via a second tubing (¶ [0022], The container 10 is also connected to the suction side of the vacuum pump 1, via a side hose 26 with filter 27. By this means the recipient is affected by two pressure levels);
wherein filtering the blood collected inside the canister using the filter positioned between the opening of the second outlet and at least the portion of the internal space of the canister comprises flowing the blood through the filter to cause filtering of solid material (¶ [0020] The centrifugated blood is then sucked via a filter arrangement 16, which in this case comprises a large filter 17 with a mask size of approximately 150-250 .mu.m, for separating bone residuals and other particles from the blood, and a fine filter 18 with a mask size of approximately 30-40 .mu.m, for separating coagulents, fat particles or the like, and collected in the canister bag 9 which may have a volume of about 2000 ml).
Regarding claim 8, Se discloses that filtering the blood collected inside the canister using the filter positioned between the opening of the second outlet and at least the portion of the internal space of the canister comprises collecting solid matter inside the filter (¶ [0027] In connection to the inlet conduit 22 the lid has an internal sleeve 42 on which a filter arrangement 16 in the form of a hose made of a fine meshed fabric has been fastened so that the blood has to pass this hose before it is tapped out through the outlet hose 23. The filter arrangement with large and fine filters 17, 18 are welded together into one piece and glued onto the sleeve 42).
Se depicts the inlet conduit 22 as extending inside the filter arrangement 16 (Fig. 1). Therefore, the contents of any collected fluid, including solids, will first enter the internal space of filter arrangement 16, where solids will be captured and retained.
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 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Se, Erik et al. (US 20030144646 A1).
Regarding claim 7, Se does not explicitly connect a first end of a venous line into the vasculature of the patient. However, Se calls for supplying blood to another liquid system (¶ [0028] The invention is not limited to the example illustrated here but can be varied within the scope of the accompanying claims. Then, instead of filling transfer bags the apparatus can be used for blood supply to another liquid system, such as a heart/lung machine. Then the canister bag 9 is connected to the blood inlet of the heart/lung machine). As known in the art, a heart/lung machine comprises cannulas or catheters that convey fluids from the machine to the patient’s veins, in order to return blood to the patient.
Se further calls for collecting and purifying blood from a patient after surgery (¶ [0029] It should also be pointed out that the invention can be used post operatively, ie for collecting blood from a patient after a surgical operation).
One would be motivated to modify Se with an appropriate cannula or catheter since Se calls for a heart/lung machine and post operative collection. Therefore, it would have been obvious to modify Se with a catheter or cannula in order to return blood as required by a heart/lung machine.
Regarding claim 9, Se does not explicitly disclose that withdrawing filtered blood from the canister via the second outlet is done without interrupting application of aspiration to the canister via the first outlet.
However, Se calls for following the example of prior art systems (¶ [0004], Autologous blood collecting devices are previously described in SE 467 725 and EP 0 742 737. According to these devices blood from the surgical operation is continuously sucked up by means of a suction hose and an anticoagulent agent is automatically added in proportion to the amount of sucked up blood).
Se further discloses that the system includes a vacuum pump (¶ [0004], A suitable sub-pressure in the system can be achieved by connection to a negative pressure source, such as a vacuum pump; ¶ [0022], The container 10 is also connected to the suction side of the vacuum pump 1, via a side hose 26 with filter 27). Se shows that the vacuum pump 1 remains in communication with container 10 (Fig. 1).
Continuously operating the pump to aspirate blood into container 10 and later into transfer bags 11, 12 will expedite the surgical procedure and also provide consistent suction when collecting blood from a patient after a surgical operation. In contrast, intermittently transferring blood would require halting Se’s system. Therefore, it would have been obvious to continuously withdraw filtered blood from the canister via the second outlet in order to consistently collect blood from the patient.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Se, Erik et al. (US 20030144646 A1) in view of Aklog; Lishan et al. (US 20130304082 A1).
Regarding claim 4, Se does not advance an aspiration catheter inside a thrombectomy catheter. Aklog discloses systems and methods for removing substantially en bloc clots, thrombi, and emboli (¶ [0002], [0003], [0022], [0038] Referring now to FIG. 1, there is illustrated a system 1);
comprising a canister and a pump (¶ [0052] Looking again at FIG. 1, system 1 can also include filter device 14; ¶ [0055] Still looking at FIG. 1, system 1 may also be provided with a pump 15); and
a first tubing connected to the canister’s inlet (¶ [0052], Filter device 14, in one embodiment, may include an inlet 141 through which fluid removed from the site of interest along with the captured undesirable material can be directed from cannula 10);
wherein aspirating blood from the patient and into the canister via the first tubing connected to the inlet comprises inserting a thrombectomy catheter into the vasculature of the patient and advancing an aspiration catheter inside the thrombectomy catheter (¶ [0061], In one embodiment, as illustrated in FIG. 4C, reinfusion cannula 16 may be incorporated as part of a double or multi-lumen introducer sheath 43 for insertion into the same vessel within which the suction cannula 10 may be situated. In particular, suction cannula 10 may be inserted and maneuvered through one lumen 44 of sheath 43).
Aklog simultaneously removes and returns blood to a patient through a double lumen catheter (¶ [0061], In such an embodiment, lumen 45 may include a distal end 451 in spaced relations to the distal end 11 of cannula 10, so that cleansed or filtered fluid may be introduced to the reinfusion site away from the site of interest where the distal end 11 of cannula 10 may be positioned). One would be motivated to modify Se with Aklog’s aspiration and thrombectomy catheters so that the system can quickly return blood to the patient. Therefore, it would have been obvious to modify Se with Aklog’s aspiration and thrombectomy catheters in order to quickly reinfuse filtered blood to the patient.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Se, Erik et al. (US 20030144646 A1) in view of Sunenshine; Peter J. et al. (US 20220226555 A1).
Regarding claim 6, Se lacks a syringe. Sunenshine discloses a manual clot aspiration and filtration system (¶ [0002], [0004], [0036] Referring to FIGS. 1 and 2, an exemplary aspiration and filtration system 10);
comprising a canister (¶ [0036], filter unit 40);
a second outlet (¶ [0036], a return one-way valve 23 is configured between the flow-valve 60 and the patient);
wherein withdrawing filtered blood from the canister via the second outlet comprises coupling a syringe to the second outlet and withdrawing blood into the syringe (¶ [0036], syringe 30; ¶ [0037] As shown in FIG. 3, an exemplary aspiration and filtration system 10 has a filtration unit 40 and a syringe 30 coupled with a flow-valve 60 to control the direction of flow of bodily fluid through the system. The plunger 32 of the syringe can be drawn from the syringe barrel 31 to pull blood into the syringe. Blood flows through the inlet one-way valve 21, through the filter 45 in the filter unit 40, through the filter sheath 25 and into the syringe).
Sunenshine manually propels small volumes of blood through a filter system with a manually operated syringe (¶ [0036], The flow-valve 60 can then be turned to a return direction to direct the filtered blood back into the patient through the return-sheath). One would be motivated to modify Se with Sunenshine’s syringe to simplify Se’s system in cases of smaller blood volumes. For example, Sunenshine describes the manual syringe among other automated options for the pump (¶ [0013], A pump, which may be a syringe or other manual pumping implement, or a powered pump, such as an electrically powered including, but not limited to, peristaltic pump, displacement pump, diaphragm pump, piston pump, centrifugal pump, a vacuum pump and the like). Therefore, it would have been obvious to modify Se with Sunenshine’s syringe in order to withdraw, filter and return smaller volumes of blood.
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Se, Erik et al. (US 20030144646 A1) in view of Swift; Kevin et al. (US 20240148956 A1).
Regarding claims 10-13, Se does not prefilter the blood using a second filter. Swift discloses systems and methods for filtering and reinfusing blood during a thrombectomy procedure (¶ [0003], [0034], [0035] FIG. 1 illustrates a passive reinfusion system 100; ¶ [0051] FIG. 5 shows another embodiment … passive reinfusion system 500);
comprising a container (¶ [0052], reservoir 508);
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further comprising prefiltering the blood prior to aspirating the blood into the canister using a second filter positioned along a first tubing (¶ [0052], The filter system 530 may comprise a first tube 502 operably connected to and in fluid communication with the pump 509 and a visualization device 504);
wherein filtering the blood collected inside the canister using a first filter comprises filtering solid materials of a first size (¶ [0054], In some embodiments, the second filter member 514 has a pore size of about 40 μm);
wherein prefiltering the blood prior to aspirating the blood into the canister using the second filter comprises filtering solid materials of a second size; wherein the second size is greater than the first size (¶ [0053], In some embodiments, the first filter member 512 has a pore size of about 750 μm to about 1000 μm);
wherein the solid materials comprise a thrombus (¶ [0101], In some embodiments, the undesired material comprises one or more thrombi, clot, lesion, pulmonary embolism, tumors, infective vegetations, foreign bodies, or other natural objects).
Swift demonstrates how to remove and examine relatively larger debris from a blood source (¶ [0034], Further, the visualization device is configured to be opened to enable removal of the captured undesirable material from the visualization device for assessing, testing, and imaging of the undesirable material). A skilled artisan would have been able to modify Se with Swift’s second filter by arranging Swift’s second filter in line with, and upstream of Se’s container. For example, Se describes a suction hose 5 that extends upstream of container 10 (¶ [0018]), where Swift’s second filter can be arranged. One would be motivated to modify Se with Swift’s second filter since Se calls for a pair of filters (¶ [0020], a large filter 17 … and a fine filter 18). Therefore, it would have been obvious to modify Se with Swift’s second filter in order for a caregiver to remove and access larger particles.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Se, Erik et al. (US 20030144646 A1) in view of Dennehey; T. Michael et al. (US 5724988 A).
Regarding claims 14-16, Se does not direct a flow of blood to an interior wall of the canister, and also lacks a canister base and second portion defining a dip. Dennehey discloses a bone marrow collection kit (col. 1, lines 5-10; col. 1, lines 55-60; col. 3, lines 50-55, FIG. 1, the bone marrow kit 10 of the present invention);
comprising a container (col. 3, lines 55-60, The collection container 12 is also illustrated in FIG. 2 and includes a body 14 constructed from a flexible material such as a plastic);
wherein aspirating blood from the patient and into the container comprises positioning an inlet to direct a flow of blood to an interior wall of the container (col. 3, lines 60-65, The container 12 includes an inlet opening 18 that provides access to the interior 16 of the container. The inlet opening 18 is defined by a frame 20 that is closed by a cap 22);
wherein aspirating blood from the patient and into the container comprises collecting the blood within a base of the container (col. 4, lines 50-60, In use, during the filtering process, bone chips, large fatty deposits, and clot-like fibrin material sinks to the bottom of the container 12, as illustrated, and surrounds the prefilter 30. Blood containing the marrow stays on top of the debris. The vertical extension of the prefilter 30 allows the blood to flow through the top of the filter while the debris is retained around the bottom);
the base comprising a first portion and a second portion, the first portion comprising an inclined surface and the second portion defining a dip (Fig. 2, container 12 has inclined walls and a rectangular portion surrounding the filter’s bottom end);
wherein filtering the blood collected inside the container using a filter comprises positioning at least a portion of a distal end of the filter within the dip so that the distal end of the filter is in contact with the blood collected in the dip (Fig. 2, prefilter 30 extends inside the rectangular portion at the bottom of container 12).
Dennehey does not explicitly disclose that the container’s inlet directs a flow of blood to the container’s interior wall. However, Dennehey discloses that the container comprises a pair of closely spaced walls (col. 4, lines 60-65, Due to the flexible walls that define the body 14 of the collection container 12, the container 12 can be manipulated, if necessary, during use). In a second embodiment, Dennehey shows a cross-section of a similar container where the walls are closely spaced and in contact with the container’s inlet (col. 5, lines 15-20, The inline filter 50 is illustrated in detail in FIG. 3. The inline filter 50 comprises a body 60 constructed preferably from two flexible plastic sheets 62 and 64). When fluid enters the inlet opening 18, it will contact one of the container’s two walls before flowing down towards the bottom. When the container is empty, its walls will collapse and cause the fluid to contact the walls’ inner surfaces. In contrast, fluid is less likely to pass directly from the inlet opening 18 towards prefilter 30, since this would require the fluid to fall directly from inlet opening 18 towards prefilter 30 without contacting the walls.
Dennehey funnels fluid towards the container’s filter and outlet, and prevents fluid from stagnating or accumulating in the container. Se calls for a container comprising a rigid outer wall and a flexible inner (¶ [0016], a canister bag 9 disposed in a stiff casing 10). A skilled artisan would have been able to modify Se with Dennehey’s interior wall flow, canister base and dip by constructing Se’s inner reservoir according to Dennehey’s example. One would be motivated to modify Se with Dennehey’s interior wall flow, canister base and dip to minimize the system’s residual volume, and to prevent blood from stagnating inside the canister. Therefore, it would have been obvious to modify Se with Dennehey’s interior wall flow, canister base and dip in order to more fully drain fluids from the container.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bringham; Richard L. et al. US 5049146 A
Herrig; Russell L. et al. US 5458566 A
Wirth Lee et al. EP 1070509 A2
Lamphere; David G. et al. US 6251291 B1
Zadno-Azizi, Gholam-Reza et al. US 20020016565 A1
Eagle; Jonathan et al. US 20110068061 A1
Park; Jason et al. US 20130324966 A1
Rossi; Ivan US 20170089746 A1
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Fax 571-273-2590
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application is assigned is 571-273-8300.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781