Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/11/20206 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-9, and 11-17 are is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0234621 (hereinafter referred as “Bellotti”), in view of US 6517508 (hereinafter referred as “Utterberg”), US 2009/0127193 (hereinafter referred as “Updyke”), and US 2018/0133385 (hereinafter referred as “Masuda”).
Regarding claims 1, 6, 7, 8, 9, 12, 13, 14, 15, 16, and 17,
Annotated fig. 19 of Bellotti is presented below to indicate claimed features.
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Bellotti teaches (Fig. 19) discloses a plasma processing system comprising:
a source of saline (1955);
a first fluid flow line (refer fig. 19 above);
a first fluid flow line valve (refer fig. 19 above) positioned between the source of saline and the first fluid flow line;
a second fluid flow line (refer fig. 19 above);
a second fluid flow line valve (refer fig. 19 above) positioned between the first fluid flow line and a second fluid flow line;
a third fluid flow line (refer fig. 19 above);
a pump (1950) positioned between the second fluid flow line and the third fluid flow line;
a prime waste container (1935) in fluid communication with the third fluid flow line;
a fourth fluid flow line (refer fig. 19 above);
a fourth fluid flow line valve (refer fig. 19 above) positioned between the first fluid flow line and the fourth fluid flow line; and
a third fluid flow path valve (refer fig. 19 above) positioned along the third fluid flow path.
Bellotti discloses that the solvent extraction device is a disposable element and is in easily accessible position and can be readily removed and replaced by a technician (refer paragraph [0149]). Bellotti teaches in embodiment of fig. 20 that the system comprises a control display (2020). Bettolli also discloses process steps including priming, plasma processing, solvent extraction.
Bellotti does not disclose a connector tube, wherein the connector tube and the solvent extraction device are configured to be alternatively inserted in a same position along the second fluid flow line.
Utterberg teaches combined arterial and venous blood tubing set is provided for transport of blood between a patient and a blood processing unit (refer abstract, fig. 1); the set comprises a hemodialyzer 16 (refer fig. 1), and a connector (refer fig. 9 indicating connection between 54 and 60 by means of 61), wherein the connector is configured to be alternatively inserted in a same position along the fluid line where the hemodialyzer is connected (refer fig. 1, fig. 9, col. 6-Line 61 to col. 7-Line 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the device of Bellotti to provide a connector tube, wherein the connector tube and the solvent extraction device are configured to be alternatively inserted in a same position along the second fluid flow line to prime the fluid circuit when the solvent extraction device is already wet and does not required to be primed as taught by Utterberg (refer col. 6-Line 61 to col. 7-Line 31).
Bellotti does not disclose that the system comprises a controller configured to execute a plurality of programmatic instructions including a first mode of operation and a second mode of operation, wherein, when in first mode of operation, the plasma processing system is in a priming mode and does not comprise solvent extraction device and when in the second mode of operation, the plasma processing system is in a delipidation mode and does comprise a solvent extraction device.
Updyke teaches a blood processing system comprising a dialysis machine (30) comprising a sorbent cartridge (24). In [0070], Updyke discloses that “the dialysis system includes a sorbent cartridge mount that permits fluid to either pass through a sorbent cartridge disposed therein or to pass directly through the sorbent cartridge holder without passing through a sorbent cartridge. As a result, the dialysis system can run in a standard mode in which dialysate flows through the sorbent cartridge or in a different mode (e.g., a cleaning mode or a rinsing mode) in which the fluid (e.g., a cleaning solution or a rinsing solution) does not pass through the sorbent cartridge. This arrangement can permit fluid to be cycled through the dialysis system even when a sorbent cartridge is not present. Thus, this arrangement permits the user to clean and/or rinse the system by removing the sorbent cartridge and circulating a cleaning solution or rinsing solution through the dialysis system”. Disclosure in [0071] indicate that the system runs in two modes, one is rinsing/priming where sorbent cartridge is removed, and dialysis mode where sorbent cartridge is present.
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the system of Bellotti to provide the system having a controller that can run in two modes, one is rinsing/priming where sorbent cartridge is removed, and dialysis mode where sorbent cartridge is present as taught by Updyke to enable rinsing/cleaning the system without passing rinsing/cleaning fluid through the sorbent cartridge.
Bellotti does not disclose details of the control display or the controller.
However, use of a programmable controller in blood processing system is well known in the art. Masuda discloses automated systems and method for processing blood and priming of fluid circuit, wherein the system comprises programmable controller for controlling fluid flow ([0041], [0062]-[0068]). Masuda also teaches that during washing of fluid circuit, dialyzer 14 is isolated by connecting connectors 36 and 38 (refer fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include a connector to isolate the solvent extraction device of Bellotti during priming and provide a controller that is configured to execute a plurality of programmable instruction to control various parts of the system as disclosed by Masuda.
Selecting how to control the components of the system would have been an obvious matter of design choice to one of ordinary skill in the art to provide desired flow configurations suitable for particular processes such as priming, plasma processing, solvent extraction etc. Also refer In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958), The court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.
Regarding claim 3, Bettolli discloses that valves are provided between the plasma or source of solvent and the first fluid path (refer fig. 19), therefore, teaches that first fluid flow path is not in fluid communication with a source of plasma or solvent.
Regarding claims 4 and 11, Bettolli further teaches a separator (1925), wherein the fourth fluid flow line is in fluid communication with the separator (Refer fig. 19).
Regarding claim 5, Bettolli further teaches an output plasma container (1945), wherein the output plasma container is in fluid communication with the pump (refer fig. 19).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding claims 1 and 9, applicant argued that US 2008/0234621 (hereinafter referred as “Bellotti”), in view of US 2009/0127193 (hereinafter referred as “Updyke”), and US 2018/0133385 (hereinafter referred as “Masuda”) fail to teach the newly added limitation of “wherein the connector tube and the solvent extraction device are configured to be alternatively inserted in a same position along the second fluid flow line”, however, the limitation is taught by Utterberg (US 6517508). Refer claim rejections above.
Conclusion
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/PRANAV N PATEL/Primary Examiner, Art Unit 1779
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