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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/02/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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 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, 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Foley et al. US 2014/0291248 A1 (hereinafter Foley) in view of Furuhashi US 2022/0176029 A1 (hereinafter Furuhashi) and Brady et al. US 2002/0159995 A1 (hereinafter Brady).
Regarding claim 1, Foley discloses a blood treatment system 10 (Fig. 1 and Par. 39 – centrifuge system 10 to separate blood components) comprising:
a reusable separation device (Par. 33 – “a reusable separation device”) comprising a plurality of cassette holders 94 (Fig. 1 – cassette holders 94) and a centrifuge 52 (Fig. 4 – centrifuge 52); and
a flow circuit 12 (Fig. 2 – flow circuit 12) comprising a plurality of cassettes 16, 16a, 16b (Fig. 2 – left cassette 16, middle cassette 16a, right cassette 16b), each cassette 16, 16a, 16b (Fig. 2) configured to be arranged on a corresponding cassette holder 94 (Fig. 1, and Par. 50 – “The sloped front panel 96 of the centrifuge system 10 includes at least one cassette holder 94 (three in the illustrated embodiment), each of which is configured to receive and grip an associated cassette 16-16b of the flow circuit 12”), a separation chamber 34 (Fig. 2 – blood separation chamber 34) fluidically connected to the plurality of cassettes 16, 16a, 16b (Fig. 2) and configured to be arranged on the centrifuge 52 (Fig. 1, Fig. 4, and Par. 40 – “…allow access to the centrifuge 52 for loading and unloading the blood separation chamber 34”), and a plurality of tubings 32, 36, 38 (Fig. 2 – tubing 32, 36, 38) fluidically connecting the plurality of cassettes 16, 16a, 16b (Fig. 2) and the separation chamber 34 (Fig. 2), the plurality of tubings 32, 36, 38 (Fig. 2) including a plasma tubing 42 (Fig. 2 – tubing 42, and Par. 37 – “The plasma may be pumped back to the left cassette 16 via tubing 42”) including a first column connector 180 (Fig. 2 – connector 180), a Luer activated port (Par. 90 – “the connector 180 comprises a luer connector”),
wherein the flow circuit 12 (Fig. 2) has a first configuration (Fig. 2 shows a configuration) for a replacement fluid therapeutic plasma exchange procedure (Par. 91) in which the first column connector 180 (Fig. 1) has first and second mating parts connected to one another (Fig. 2 – the two ends of connector 180 are connected to each other), and a second configuration (Fig. 16 shows another configuration) for an adsorption therapeutic plasma exchange procedure (Par. 90-91) in which the flow circuit 12 (Fig. 2) further comprises an adsorption device 170 (Fig. 16 – adsorption device 170) and the adsorption device 170 (Fig. 16) is connected in line with plasma tubing 42 (Fig. 16, and Par. 91 – “…the adsorption device 170 to fluidly connect the adsorption device or column 170 inline with the downstream and upstream portions of the tubing 42”) and the first and second mating parts of the first column connector 180 (Fig. 16) are connected to the mating parts of the adsorption device 170 (Fig. 16, and Par. 91).
However, Foley does not disclose a check valve, an adsorption device having a second column connector, and the first and second mating parts of the first column connector are connected to the corresponding first and second parts of the second column connector.
Furuhashi, in the same field of endeavor of blood purification device (Title), teaches a check valve 37 (Fig. 2, and Par. 67).
Brady, in the same field of endeavor of extracorporeal blood processing (Title), teaches an adsorption device 30 (Fig. 7 – adsorption device 30) having a second column connector 56 (Fig. 7 – fittings 56 on both ends).
Brady, in the same field of endeavor of extracorporeal blood processing (Title) and in another embodiment, teaches the device 32 (Fig. 4A-4B) having a second column connector 42 (Fig. 4A-4B – convention mating luer fittings 42), and the first and second mating parts of the first column connector 26/27 (Fig. 4A-4B – blood lines 26/27) are connected to the corresponding first and second parts of the second column connector 42 (Fig. 4A-4B – line 26 is connected to the left luer fitting 42 of the device 32, and line 27 is connected to the right luer fitting 42 of the device 32).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Foley to further include a check valve on a plasma line as taught by Furuhashi, in order to suppress backflow of the liquid from one section to another within the flow circuit (Par. 37 of Furuhashi).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the adsorption device of Foley to further include a second column connector as taught by Brady, in order to couple the adsorption device to the components of the blood circuit (Par. 121 of Brady). Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the column connectors of the combined device to connect to each other as taught by another embodiment of Brady, in order to enable quick attachment and removal in-line (Par. 111 of Brady).
Regarding claim 2, Foley in view of Furuhashi in view of Brady discloses the invention of claim 1. The combination further discloses wherein each of the cassette holders 94 (Fig. 9 of Foley) includes a valve and sensor array 132 (Fig. 9 of Foley – valve assembly 132) having a plurality of valve actuators 134 (Fig. 9 of Foley – valve actuators 134) and further includes two associated pump stations 92 (Fig. 9 of Foley – pair of peristaltic pump stations 92, and Par. 61),
wherein each of the cassettes 16, 16a, 16b (Fig. 2 of Foley) includes a plurality of valve stations 110 (Fig. 8 of Foley – valve stations 110) and sensor stations 112 (Fig. 8 of Foley – sensing stations 112) on one side (Fig. 8 of Foley), and a plurality of fluid paths 114 (Fig. 7 of Foley – liquid paths 114) on another side (Fig. 7 of Foley),
wherein the valve actuators 134 (Fig. 9 of Foley) are selectively operable to actuate corresponding valve stations 110 (Fig. 8 of Foley) to provide different flow paths on the cassettes 16, 16a, 16b (Fig. 2 of Foley) formed by one or more of the fluid paths (Par. 54 of Foley – “an array of channels or paths 114 for conveying liquids. The valve stations 110 communicate with the liquid paths 114 through the interior wall 100 to interconnect them in a predetermined manner”), and
wherein the pump stations 92 (Fig. 9 of Foley) are selectively operable to cause fluid flow through the flow paths (Fig. 2 of Foley, Fig. 7-9 of Foley, and Par. 61 of Foley – “The pump stations 92 are operated to cause fluid flow through the cassette 16”).
Regarding claim 3, Foley in view of Furuhashi in view of Brady discloses the invention of claim 2. The combination further discloses wherein the plurality of cassettes 16, 16a, 16b (Fig. 2 of Foley) includes a left cassette 16 (Fig. 2 of Foley), a middle cassette 16a (Fig. 2 of Foley) and a right cassette 16b (Fig. 2 of Foley), wherein:
the left cassette 16 (Fig. 2 of Foley) is configured to receive whole blood from a blood supply (Fig. 2 of Foley, and Par. 35 of Foley – “The blood source access devices 14 and 14a are connected by tubing to a left cassette 16”),
the separation chamber 34 (Fig. 2 of Foley) is configured to receive the whole blood from the left cassette 16 (Fig. 2 of Foley, and Par. 37 of Foley – “The left cassette 16 also includes tubing 32 which is connected to a blood separation chamber 34 of the flow circuit 12 for flowing anticoagulated blood thereto”),
the centrifuge 52 (Fig. 3 of Foley) is configured to be operated to separate the whole blood in the separation chamber 34 (Fig. 2-3 of Foley) into a cellular component and a substantially cell-free plasma component (Par. 65 of Foley – “the centrifuge 52 rotates the blood separation chamber 34, thereby centrifugally separating whole blood received from a blood source into component parts, e.g., red blood cells, plasma, and buffy coat comprising platelets and leukocytes”),
the middle cassette 16a (Fig. 2 of Foley) is configured to receive the cellular component from the separation chamber 34 (Fig. 2 of Foley, and Par. 37 of Foley – “cellular blood components are returned to the middle cassette 16a of the flow circuit 12 from the blood separation chamber 34 via tubing 36”),
the right cassette 16b (Fig. 2 of Foley) is configured to receive the plasma from the separation chamber 34 (Fig. 2, and Par. 37 – “…while substantially cell-free plasma is returned to a right cassette 16b of the flow circuit 12 from the blood separation chamber 34 via tubing 38”), and
the plasma tubing 42 (Fig. 2 of Foley) is fluidically connected to and extends downstream from the right cassette 16b (Fig. 2 of Foley).
Regarding claim 4, Foley in view of Furuhashi in view of Brady discloses the invention of claim 3. The combination further discloses wherein in the first configuration (Fig. 2 of Foley):
a replacement fluid container having a replacement fluid (Par. 35 of Foley – “anticoagulant container (not illustrated)”) is fluidically connected to the middle cassette 16a (Fig. 2 of Foley, and Par. 35 of Foley – “The tubing 20 is connected, through the middle cassette 16a, to additional tubing 22, which includes a container access device 24 (e.g., a sharpened cannula or spike connector) for accessing the interior of an anticoagulant container (not illustrated)”) and the valve stations and pump stations are operated to direct the replacement fluid through the middle cassette 16a (Fig. 2 of Foley) to the blood supply (Par. 35 of Foley – “During a blood treatment operation, anticoagulant from the anticoagulant container is added to the blood from the blood source at the y-connector 18 prior to entering the left cassette 16”, thus indicating the fluid from container has to travel through tubing 22, through the channels formed by valves and pump of the middle cassette to reach y-connector 18),
a collection container 44 (Fig. 2 of Foley – container 44) is fluidically connected to the right cassette 16b (Fig. 2 of Foley) and the valve stations and pump stations are operated to direct the plasma through the right cassette 16b (Fig. 2 of Foley) to the collection container 44 (Fig. 2 of Foley, and Par. 37 of Foley – “The plasma may be pumped… into a container 44 via different tubing 46”).
Regarding claim 12, Foley discloses a flow circuit 12 (Fig. 2 – flow circuit 12) for a blood treatment system 10 (Fig. 1 and Par. 39 – centrifuge system 10 to separate blood components), the flow circuit 12 (Fig. 2) comprising:
a plurality of cassettes 16, 16a, 16b (Fig. 2 – left cassette 16, middle cassette 16a, right cassette 16b);
a separation chamber 34 (Fig. 2 – blood separation chamber 34) fluidically connected to the plurality of cassettes 16, 16a, 16b (Fig. 2); and
a plurality of tubings 32, 36, 38 (Fig. 2 – tubing 32, 36, 38) fluidically connecting the plurality of cassettes 16, 16a, 16b (Fig. 2) and the separation chamber 34 (Fig. 2), the plurality of tubings 32, 36, 38 (Fig. 2) including a plasma tubing 42 (Fig. 2 – tubing 42, and Par. 37 – “The plasma may be pumped back to the left cassette 16 via tubing 42”) including a first column connector 180 (Fig. 2 – connector 180), a Luer activated port (Par. 90 – “the connector 180 comprises a luer connector”),
wherein the flow circuit 12 (Fig. 2) has a first configuration (Fig. 2 shows a configuration) for a replacement fluid therapeutic plasma exchange procedure in which the first column connector 180 (Fig. 1) has first and second mating parts connected to one another (Fig. 2 – the two ends of connector 180 are connected to each other), and a second configuration (Fig. 16 shows another configuration) for an adsorption therapeutic plasma exchange procedure (Par. 90-91) in which the flow circuit 12 (Fig. 2) further comprises an adsorption device 170 (Fig. 16 – adsorption device 170) and the adsorption device 170 (Fig. 16) is connected in line with plasma tubing 42 (Fig. 16, and Par. 91 – “…the adsorption device 170 to fluidly connect the adsorption device or column 170 inline with the downstream and upstream portions of the tubing 42”) and between the first and second mating parts of the first column connector 180 (Fig. 16) such that the first and second mating parts of the first column connector 180 (Fig. 16) are connected to the mating parts of the adsorption device 170 (Fig. 16, and Par. 91).
However, Foley does not disclose a check valve, an adsorption device having a second column connector, the first and second mating parts of the first column connector are connected to the corresponding first and second parts of the second column connector.
Furuhashi, in the same field of endeavor of blood purification device (Title), teaches a check valve 37 (Fig. 2, and Par. 67).
Brady, in the same field of endeavor of extracorporeal blood processing (Title), teaches an adsorption device 30 (Fig. 7 – adsorption device 30) having a second column connector 56 (Fig. 7 – fittings 56 on both ends).
Brady, in the same field of endeavor of extracorporeal blood processing (Title) and in another embodiment, teaches the device 32 (Fig. 4A-4B) having a second column connector 42 (Fig. 4A-4B – convention mating luer fittings 42), and the first and second mating parts of the first column connector 26/27 (Fig. 4A-4B – blood lines 26/27) are connected to the corresponding first and second parts of the second column connector 42 (Fig. 4A-4B – line 26 is connected to the left luer fitting 42 of the device 32, and line 27 is connected to the right luer fitting 42 of the device 32).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Foley to further include a check valve on a plasma line as taught by Furuhashi, in order to suppress backflow of the liquid from one section to another within the flow circuit (Par. 37 of Furuhashi).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the adsorption device of Foley to further include a second column connector as taught by Brady, in order to couple the adsorption device to the components of the blood circuit (Par. 121 of Brady). Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the column connectors of the combined device to connect to each other as taught by another embodiment of Brady, in order to enable quick attachment and removal in-line (Par. 111 of Brady).
Regarding claim 13, Foley in view of Foley in view of Furuhashi in view of Brady discloses the invention of claim 12. The combination further discloses wherein the plurality of cassettes 16, 16a, 16b (Fig. 2 of Foley) includes a left cassette 16 (Fig. 2 of Foley), a middle cassette 16a (Fig. 2 of Foley) and a right cassette 16b (Fig. 2 of Foley), wherein:
the left cassette 16 (Fig. 2 of Foley) is configured to receive whole blood from a blood supply (Fig. 2 of Foley, and Par. 35 of Foley – “The blood source access devices 14 and 14a are connected by tubing to a left cassette 16”),
the separation chamber 34 (Fig. 2 of Foley) is configured to receive the whole blood from the left cassette 16 (Fig. 2 of Foley, and Par. 37 of Foley – “The left cassette 16 also includes tubing 32 which is connected to a blood separation chamber 34 of the flow circuit 12 for flowing anticoagulated blood thereto”), wherein the whole blood is separated into a cellular component and a substantially cell-free plasma component (Par. 65 of Foley – “…centrifugally separating whole blood received from a blood source into component parts, e.g., red blood cells, plasma, and buffy coat comprising platelets and leukocytes”),
the middle cassette 16a (Fig. 2 of Foley) is configured to receive the cellular component from the separation chamber 34 (Fig. 2 of Foley, and Par. 37 of Foley – “cellular blood components are returned to the middle cassette 16a of the flow circuit 12 from the blood separation chamber 34 via tubing 36”),
the right cassette 16b (Fig. 2 of Foley) is configured to receive the plasma from the separation chamber 34 (Fig. 2, and Par. 37 – “…while substantially cell-free plasma is returned to a right cassette 16b of the flow circuit 12 from the blood separation chamber 34 via tubing 38”), and
the plasma tubing 42 (Fig. 2 of Foley) is fluidically connected to and extends downstream from the right cassette 16b (Fig. 2 of Foley).
Regarding claim 14, Foley in view of Furuhashi in view of Brady discloses the invention of claim 13. The combination further discloses wherein in the first configuration (Fig. 2 of Foley):
a replacement fluid container having a replacement fluid (Par. 35 of Foley – “anticoagulant container (not illustrated)”) is fluidically connected to the middle cassette 16a (Fig. 2 of Foley, and Par. 35 of Foley – “The tubing 20 is connected, through the middle cassette 16a, to additional tubing 22, which includes a container access device 24 (e.g., a sharpened cannula or spike connector) for accessing the interior of an anticoagulant container (not illustrated)”), and a flow path 18+22 (Fig. 2 – y-connector 18 and tubing 22) for the replacement fluid is provided through the middle cassette 16a (Fig. 2 of Foley) and the left cassette 16 (Fig. 2) to the blood supply (Par. 35 – “During a blood treatment operation, anticoagulant from the anticoagulant container is added to the blood from the blood source at the y-connector 18 prior to entering the left cassette 16”), and
a collection container 44 (Fig. 2 of Foley – container 44) is fluidically connected to the right cassette 16b (Fig. 2 of Foley) such that the plasma is directed through the right cassette 16b (Fig. 2 of Foley) to the collection container 44 (Fig. 2 of Foley, and Par. 37 of Foley – “The plasma may be pumped… into a container 44 via different tubing 46”),
wherein flow of the replacement fluid and cellular component to the blood supply via the left cassette 16 (Fig. 2) and flow of the substantially cell free plasma into the collection container 44 (Fig. 2) via the right cassette 16b (Fig. 2) are maintained (Par. 37 – “The cellular blood components may be pumped to the left cassette 16 via tubing 40, where they are returned to the blood source. The plasma may be pumped back to the left cassette 16 via tubing 42 for return to the blood source and/or it may be pumped into a container 44 via different tubing 46”) while the whole blood is drawn from the blood supply and received by the left cassette 16 (Fig. 2, and Par. 37 – “The left cassette 16 also includes tubing 32 which is connected to a blood separation chamber 34 of the flow circuit 12 for flowing anticoagulated blood thereto”).
Claims 5-9 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Foley in view of Furuhashi in view of Brady as applied to claim 4 above, and further in view of Min et al. US 6,027,657 A (hereinafter Min).
Regarding claim 5, Foley in view of Furuhashi in view of Brady discloses the invention of claim 4. The combination further discloses wherein in the second configuration (Fig. 16 of Foley):
a flush fluid is fluidically connected to the left cassette 16 (Fig. 2 of Foley, and Par. 36 of Foley – “Although not illustrated, the container access device 30 may be associated with a container having an amount of fluid (e.g., saline) to be used to prime the flow circuit 12”) and,
the valve stations and pump stations are operated to direct the flush fluid through the left cassette, the separation chamber, the right cassette, the adsorption device, the Luer activated port, the check valve and the middle cassette (Par. 36 of Foley – “Although not illustrated, the container access device 30 may be associated with a container having an amount of fluid (e.g., saline) to be used to prime the flow circuit 12”).
However, the combination does not disclose a flush fluid collection container is fluidically connected to the middle cassette, and direct the flush fluid to the flush fluid collection container.
Min, in the same field of endeavor of centrifugal processing systems (Col. 1, line 6-7), teaches a flush fluid collection container (Fig. 6 – WASTE) is fluidically connected to the left cassette 23L (Fig. 6 – left cassette 23L), and direct the flush fluid to the flush fluid collection container (Fig. 6, and Col. 8, line 5-7 – “Tubing T20 extends from channel C2 of the left cassette 23L to a container intended to receive waste priming fluid, designated WASTE”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a flush fluid collection container as taught by Min, in order to receive waste priming fluid (Col. 8, line 5-7 of Min). Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of the collection container to so it was connected to the middle cassette, since this claimed position of the flush fluid collection container does not change the container ability to receive the priming fluid after priming the device. Since applicant has not given any criticality to why the position of the container disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 6, Foley in view of Furuhashi in view of Brady in view of Min discloses the invention of claim 5. The combination further discloses wherein the flow circuit has a third configuration in which:
the valve stations 110 (Fig. 8 of Foley) and pump stations 92 (Fig. 9 of Foley) are operated to direct the whole blood into the left cassette 16 (Fig. 2 of Foley) and to the separation chamber 34 (Fig. 2, and Par. 37 of Foley – “The left cassette 16 also includes tubing 32 which is connected to a blood separation chamber 34 of the flow circuit 12 for flowing anticoagulated blood thereto… The destination of the plasma (and the other fluids passing through the cassettes) depends upon the actuation of the various valves of the cassette”),
the whole blood is separated into the cellular component and substantially cell-free plasma in the separation chamber 34 (Fig. 2 of Foley, and Par. 65 of Foley – “the centrifuge 52 rotates the blood separation chamber 34, thereby centrifugally separating whole blood received from a blood source into component parts, e.g., red blood cells, plasma, and buffy coat comprising platelets and leukocytes”), and
the valve stations 110 (Fig. 8 of Foley) and pump stations 92 (Fig. 9 of Foley) are further operated to remove the plasma from the separation chamber 34 (Fig. 16 of Foley), through the right cassette 16b (Fig. 16 of Foley) and into the adsorption device 170 (Fig. 16 of Foley, and Par. 38 of Foley – “The destination of the plasma (and the other fluids passing through the cassettes) depends upon the actuation of the various valves of the cassette”, and Par. 92 of Foley – “the plasma is routed through the right cassette 16b and exits via tubing 42, to flow through the adsorption device 170”), such that the plasma displaces the flush fluid from the adsorption device 170 (Fig. 16 of Foley) into the middle cassette 16a (Fig. 16 of Foley; Examiner notes that since Par. 91 of Foley discussed and as established in claim 5 that the adsorption device 170 is primed, priming fluid has to still be within the adsorption device 170 once blood is drawn into the flow circuit 12, thus inflowing of plasma will displace the pre-existent priming fluid within adsorption device 170).
However, the combination does not disclose a divert prime collection container is fluidically connected to the middle cassette, displace the flush fluid from the middle cassette into the divert prime collection container.
Foley, in another embodiment, teaches a divert prime collection container 184 (Fig. 17 – additional reservoir 184) is fluidically connected to the middle cassette 16a (Fig. 17), displace the flush fluid from the middle cassette 16a (Fig. 17) into the divert prime collection container 184 (Fig. 17, and Par. 107 – “The processed plasma flows out of the adsorption column 174 and back into the flow circuit 12 of the blood separation system, where it enters the post-adsorption reservoir 184”, thus pushing fluid into the middle cassette 16a via tubing 40 and to the reservoir 184 via tubing 185).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a collection container connected to the middle cassette, also as taught by Foley, in order to receive targeted or desired fluid from the second cassette. It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a collection container, as Foley teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 7, Foley in view of Furuhashi in view of Brady in view of Min discloses the invention of claim 6. However, the combination does not disclose wherein a volume of the adsorption device is 60 mL or less.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the volume of the adsorption device to be 60 mL or less, in order to fit the particular procedure being done since this claimed dimension of the adsorption device does not change the its ability to receive an amount of processed blood for treatment. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 65 of Applicant’s PG-PUB), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 8, Foley in view of Furuhashi in view of Brady in view of Min discloses the invention of claim 5. The combination further discloses wherein the flow circuit has a fourth configuration in which:
the valve stations 110 (Fig. 8 of Foley) and pump stations 92 (Fig. 9 of Foley) are operated to direct the whole blood into the left cassette 16 (Fig. 2 of Foley) and to the separation chamber 34 (Fig. 2, and Par. 37 of Foley – “The left cassette 16 also includes tubing 32 which is connected to a blood separation chamber 34 of the flow circuit 12 for flowing anticoagulated blood thereto… The destination of the plasma (and the other fluids passing through the cassettes) depends upon the actuation of the various valves of the cassette”),
the whole blood is separated into the cellular component and substantially cell-free plasma in the separation chamber 34 (Fig. 2 of Foley, and Par. 65 of Foley – “the centrifuge 52 rotates the blood separation chamber 34, thereby centrifugally separating whole blood received from a blood source into component parts, e.g., red blood cells, plasma, and buffy coat comprising platelets and leukocytes”), and
the valve stations 110 (Fig. 8 of Foley) and pump stations 92 (Fig. 9 of Foley) are further operated to remove the plasma from the separation chamber 34 (Fig. 16 of Foley), through the right cassette 16b (Fig. 16 of Foley) and into the adsorption device 170 (Fig. 16 of Foley, and Par. 38 of Foley – “The destination of the plasma (and the other fluids passing through the cassettes) depends upon the actuation of the various valves of the cassette”, and Par. 92 of Foley – “the plasma is routed through the right cassette 16b and exits via tubing 42, to flow through the adsorption device 170”), such that the plasma displaces the flush fluid from the adsorption device 170 (Fig. 16 of Foley) through the Luer activated port (Fig. 16 of Foley – luer port of connector 180; Examiner notes that since Par. 91 of Foley discussed and as established in claim 5 that the adsorption device 170 is primed, priming fluid has to still be within the adsorption device 170 once blood is drawn into the flow circuit 12, thus inflowing of plasma will displace the pre-existent priming fluid within adsorption device 170 through the port of luer connector 180).
However, the combination does not disclose a divert prime collection container is fluidically connected to the Luer activated port, displace the flush fluid from the adsorption device and into the divert prime collection container.
Foley, in another embodiment, teaches a divert prime collection container 184 (Fig. 17 – additional reservoir 184) is fluidically connected to the Luer activated port (Fig. 17 – Luer port 180 and reservoir 184 are fluidly communicative), displace the flush fluid through the Luer activated port (Fig. 17) and into the divert prime collection container 184 (Fig. 17, and Par. 107 – “The processed plasma flows out of the adsorption column 174 and back into the flow circuit 12 of the blood separation system, where it enters the post-adsorption reservoir 184”, thus pushing fluid past the Luer port 180 to reach the middle cassette 16a via tubing 40 and into the reservoir 184 via tubing 185).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a collection container connected to the Luer activated port, also as taught by Foley, in order to receive targeted or desired fluid from the second cassette. It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a collection container, as Foley teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 9, Foley in view of Furuhashi in view of Brady in view of Min discloses the invention of claim 8. The combination further discloses wherein the flow circuit has a fifth configuration in which:
the valve stations 110 (Fig. 8 of Foley) and the pump stations 92 (Fig. 9 of Foley) are operated to provide the cellular component from the separation chamber 34 (Fig. 16 of Foley) into the middle cassette 16a (Fig. 16 of Foley, and Par. 37 of Foley – “cellular blood components are returned to the middle cassette 16a of the flow circuit 12 from the blood separation chamber 34 via tubing 36”, and Par. 38 of Foley – “The destination of the plasma (and the other fluids passing through the cassettes) depends upon the actuation of the various valves of the cassette”), from the middle cassette 16a (Fig. 16 of Foley) to the left cassette 16 (Fig. 16 of Foley) via corresponding tubing (Par. 37 of Foley – “The cellular blood components may be pumped to the left cassette 16 via tubing 40…”), and from the left cassette 16 (Fig. 16 of Foley) to the blood supply (Par. 37 of Foley – “The cellular blood components may be pumped to the left cassette 16 via tubing 40, where they are returned to the blood source”), wherein the check valve 37 (Fig. 2 of Furuhashi) prevents back flow of the cellular material toward the adsorption device 170 (Fig. 16 of Foley) while the valve stations 110 (Fig. 7-8 of Foley) and the pump stations 92 (Fig. 9 of Foley) continue to provide the plasma to the adsorption device 170 (Fig. 16 of Foley).
Examiner notes that once the modification is made as discussed in claim 1, the check valve 37 of Furuhashi will be incorporated into the plasma line 42 of Foley, thus preventing backflow of fluid.
Regarding claim 15, Foley in view of Furuhashi in view of Brady discloses the invention of claim 14. The combination further discloses wherein in the second configuration (Fig. 16 of Foley):
a flush fluid is fluidically connected to the left cassette 16 (Fig. 2 of Foley, and Par. 36 of Foley – “Although not illustrated, the container access device 30 may be associated with a container having an amount of fluid (e.g., saline) to be used to prime the flow circuit 12”); and
a flow path for the flush fluid is provided through the left cassette, the separation chamber, the right cassette, the adsorption device, the Luer activated port, the check valve and the middle cassette (Par. 36 of Foley – “Although not illustrated, the container access device 30 may be associated with a container having an amount of fluid (e.g., saline) to be used to prime the flow circuit 12”).
However, the combination does not disclose a flush fluid collection container is fluidically connected to the middle cassette, direct the flush fluid to the flush fluid collection container.
Min, in the same field of endeavor of centrifugal processing systems (Col. 1, line 6-7), teaches a flush fluid collection container (Fig. 6 – WASTE) is fluidically connected to the left cassette 23L (Fig. 6 – left cassette 23L), and direct the flush fluid to the flush fluid collection container (Fig. 6, and Col. 8, line 5-7 – “Tubing T20 extends from channel C2 of the left cassette 23L to a container intended to receive waste priming fluid, designated WASTE”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a flush fluid collection container as taught by Min, in order to receive waste priming fluid (Col. 8, line 5-7 of Min). Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of the collection container to so it was connected to the middle cassette, since this claimed position of the flush fluid collection container does not change the container ability to receive the priming fluid after priming the device. Since applicant has not given any criticality to why the position of the container disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 16, Foley in view of Furuhashi in view of Brady in view of Min discloses the invention of claim 15. The combination further discloses wherein the flow circuit has a third configuration in which:
a flow path for the whole blood is provided into the left cassette 16 (Fig. 2 of Foley) and to the separation chamber 34 (Fig. 2 of Foley, and Par. 37 of Foley – “The left cassette 16 also includes tubing 32 which is connected to a blood separation chamber 34 of the flow circuit 12 for flowing anticoagulated blood thereto…”), the whole blood is separated into the cellular component and substantially cell-free plasma in the separation chamber 34 (Fig. 2 of Foley, and Par. 65 of Foley – “…centrifugally separating whole blood received from a blood source into component parts, e.g., red blood cells, plasma, and buffy coat comprising platelets and leukocytes”), and
a flow path is provided to remove the plasma from the separation chamber 34 (Fig. 16 of Foley), through the right cassette 16b (Fig. 16 of Foley) and into the adsorption device 170 (Fig. 16 of Foley, and Par. 92 of Foley – “the plasma is routed through the right cassette 16b and exits via tubing 42, to flow through the adsorption device 170”), such that the plasma displaces flush fluid from the adsorption device 170 (Fig. 16 of Foley) into the middle cassette 16a (Fig. 16 of Foley; Examiner notes that since Par. 91 of Foley discussed and as established in claim 5 that the adsorption device 170 is primed, priming fluid has to still be within the adsorption device 170 once blood is drawn into the flow circuit 12, thus inflowing of plasma will displace the pre-existent priming fluid within adsorption device 170).
However, the combination does not disclose a divert prime collection container is fluidically connected to the middle cassette, displace the flush fluid from the middle cassette into the divert prime collection container.
Foley, in another embodiment, teaches a divert prime collection container 184 (Fig. 17 – additional reservoir 184) is fluidically connected to the middle cassette 16a (Fig. 17), displace the flush fluid from the middle cassette 16a (Fig. 17) into the divert prime collection container 184 (Fig. 17, and Par. 107 – “The processed plasma flows out of the adsorption column 174 and back into the flow circuit 12 of the blood separation system, where it enters the post-adsorption reservoir 184”, thus pushing fluid into the middle cassette 16a via tubing 40 and to the reservoir 184 via tubing 185).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a collection container connected to the middle cassette, also as taught by Foley, in order to receive targeted or desired fluid from the second cassette. It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a collection container, as Foley teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 17, Foley in view of Furuhashi in view of Brady in view of Min discloses the invention of claim 16. However, the combination does not disclose wherein a volume of the adsorption device is 60 mL or less.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the volume of the adsorption device to be 60 mL or less, in order to fit the particular procedure being done since this claimed dimension of the adsorption device does not change the its ability to receive an amount of processed blood for treatment. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 65 of Applicant’s PG-PUB), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 18, Foley in view of Furuhashi in view of Brady in view of Min discloses the invention of claim 15. The combination further discloses wherein the flow circuit has a fourth configuration in which:
a flow path is provided for the whole blood into the left cassette 16 (Fig. 2 of Foley) and to the separation chamber 34 (Fig. 2 of Foley, and Par. 37 of Foley – “The left cassette 16 also includes tubing 32 which is connected to a blood separation chamber 34 of the flow circuit 12 for flowing anticoagulated blood thereto…”),
the whole blood is separated into the cellular component and substantially cell-free plasma in the separation chamber 34 (Fig. 2 of Foley, and Par. 65 of Foley – “the centrifuge 52 rotates the blood separation chamber 34, thereby centrifugally separating whole blood received from a blood source into component parts, e.g., red blood cells, plasma, and buffy coat comprising platelets and leukocytes”), and
a flow path is provided to remove the plasma from the separation chamber 34 (Fig. 16 of Foley), through the right cassette 16b (Fig. 16 of Foley) and into the adsorption device 170 (Fig. 16 of Foley, and Par. 92 of Foley – “the plasma is routed through the right cassette 16b and exits via tubing 42, to flow through the adsorption device 170”), such that the plasma displaces the flush fluid from the adsorption device 170 (Fig. 16 of Foley) through the Luer activated port (Fig. 16 of Foley – luer port of connector 180; Examiner notes that since Par. 91 of Foley discussed and as established in claim 15 that the adsorption device 170 is primed, priming fluid has to still be within the adsorption device 170 once blood is drawn into the flow circuit 12, thus inflowing of plasma will displace the pre-existent priming fluid within adsorption device 170 through the port of luer connector 180).
However, the combination does not disclose a divert prime collection container is fluidically connected to the Luer activated port, and displace the flush fluid from the adsorption device into the divert prime collection container.
Foley, in another embodiment, teaches a divert prime collection container 184 (Fig. 17 – additional reservoir 184) is fluidically connected to the Luer activated port (Fig. 17 – luer port 180 and reservoir 184 are fluidly communicative), displace the flush fluid through the Luer activated port (Fig. 17) and into the divert prime collection container 184 (Fig. 17, and Par. 107 – “The processed plasma flows out of the adsorption column 174 and back into the flow circuit 12 of the blood separation system, where it enters the post-adsorption reservoir 184”, thus pushing fluid past the Luer port 180 to reach the middle cassette 16a via tubing 40 and into the reservoir 184 via tubing 185).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a collection container connected to the Luer activated port, also as taught by Foley, in order to receive targeted or desired fluid from the second cassette. It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a collection container, as Foley teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 19, Foley in view of Furuhashi in view of Brady in view of Min discloses the invention of claim 18. The combination further discloses wherein the flow circuit has a fifth configuration in which:
a flow path is provided for the cellular component from the separation chamber 34 (Fig. 16) into the middle cassette 16a (Fig. 16, and Par. 37 – “cellular blood components are returned to the middle cassette 16a of the flow circuit 12 from the blood separation chamber 34 via tubing 36”), from the middle cassette 16a (Fig. 16 of Foley) to the left cassette 16 (Fig. 16 of Foley) via corresponding tubing (Par. 37 of Foley – “The cellular blood components may be pumped to the left cassette 16 via tubing 40…”), and from the left cassette 16 (Fig. 16 of Foley) to the blood supply (Par. 37 of Foley – “The cellular blood components may be pumped to the left cassette 16 via tubing 40, where they are returned to the blood source”), wherein the check valve 37 (Fig. 2 of Furuhashi) prevents back flow of the cellular material toward the adsorption device 170 (Fig. 16 of Foley), and
a flow path further provides the plasma to the adsorption device 170 (Fig. 16 of Foley, and Par. 92 – “The plasma is routed through the right cassette 16b and exits via tubing 42, to flow through the adsorption device 170”).
Examiner notes that once the modification is made as discussed in claim 12, the check valve 37 of Furuhashi will be incorporated into the plasma line 42 of Foley, thus preventing backflow of fluid.
Regarding claim 20, Foley in view of Furuhashi in view of Brady in view of Min discloses the invention of claim 18. However, the combination does not disclose wherein a volume of the adsorption device is 150 mL or more.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the volume of the adsorption device to be 150 mL or more, in order to fit the particular procedure being done since this claimed dimension of the adsorption device does not change the its ability to receive an amount of processed blood for treatment. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 71 of Applicant’s PG-PUB), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Foley in view of Furuhashi in view of Brady in view of Min as applied to claim 9 above, and further in view of Hochrein et al. US 2012/0267290 A1 (hereinafter Hochrein).
Regarding claim 10, Foley in view of Furuhashi in view of Brady in view of Min discloses the invention of claim 9. The combination further discloses wherein the divert prime collection container 184 (Fig. 17 of Foley) is connected to a scale (Par. 105 of Foley – “each reservoir 44 and 184 is associated with a weight scale or sensor, which measures the weight of fluid in the reservoir”), and the valve stations 110 (Fig. 7-8 of Foley) and pump stations 92 (Fig. 8 of Foley) are operated to change the flow circuit 12 from the fourth configuration to the fifth configuration (Fig. 2, and Par. 53 – “The valve stations 110 communicate with the liquid paths 114 through the interior wall 100 to interconnect them in a predetermined manner”).
However, the combination does not disclose change the flow circuit from one configuration to another configuration in response to the divert prime collection container reaching a predetermined weight.
Hochrein, in the same field of endeavor of blood treatment apparatus (Title), teaches change the flow circuit from one configuration to another configuration (Par. 12 – “The monitoring of the fluid flow according to the invention can replace the known monitoring of the function of the change-over clamp”, and Par. 7 discusses that “In the known blood treatment apparatuses for therapeutic apheresis, the line leading away from the purification unit branches into a first line segment leading to the blood return line and a second line segment leading to the collection container. During the treatment mode, the purified plasma flows through the first line segment to the blood return line, while the second line segment is closed. In the filling and rinsing mode, on the other hand, the rinsing solution is conveyed through the second line segment into the collection bag. The fluid flow is changed over by means of a change-over clamp, into which both line segments of the line leading away from the purification unit are placed”) in response to the divert prime collection container reaching a predetermined weight (Par. 12 – “the change in weight of the collection container is monitored. It is possible to conclude that there is a defective state solely on the basis of the change in weight of the collection container. The monitoring of the fluid flow according to the invention can replace the known monitoring of the function of the change-over clamp”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination such that the function of the device is switched from priming to treatment upon detection of a predetermined weight as taught by Hochrein, in order to monitor the fluid flow (Par. 13 of Hochrein) and ensure that purified plasma does not get into the collection bag (Par. 8 of Hochrein).
Regarding claim 11, Foley in view of Furuhashi in view of Brady in view of Min in view of Hochrein discloses the invention of claim 10. However, the combination does not disclose wherein a volume of the adsorption device is 150 mL or more.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the volume of the adsorption device to be 150 mL or more, in order to fit the particular procedure being done since this claimed dimension of the adsorption device does not change the its ability to receive an amount of processed blood for treatment. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 71 of Applicant’s PG-PUB), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Greenberg et al. US 2017/0080143 A1 teaches an apheresis module.
Gura US 2022/0016328 A1 teaches a Luer activated valve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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