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 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Petralia et al. (US 2023/0055777 A1) in view of Stringer et al. (US 2002/0114731 A1).
Regarding claim 1, Petralia discloses a system for priming a medical fluid system (Figs. 1-2, feat. 1; ¶0017-0018), comprising: a fluid connector configured to interface with a sterile fluid source (4, 4a; ¶0018-0022: duct 4 communicates with a source of operating fluid via port 4a); and a fluid reservoir downstream of an in fluid communication with the fluid connector (3; ¶0019), the fluid reservoir comprising: a first connector (5a) configured to fluidly couple with an inflow line of the medial fluid system (5; ¶0018-0019 and 0023); a second connector (6a) configured to fluidly couple with an outflow line of the medical fluid system (6; ¶0018-0019 and 0023).
Petralia does not disclose a gas release valve configured to permit gas to pass therethrough and prevent fluid from passing therethrough.
Stringer teaches a blood filter for gas removal in an extracorporeal blood circuit (Figs. 1-2B, feat. 40) comprising a fluid inlet (42), a fluid outlet (43), a sensor (45), and a gas removal port (44) coupled to a valve (36; ¶0033-0036 and 0043-0045). The valve is operated in response to the detection of a the presence of a predetermined volume of gas by the sensor, and allows the collected gas to be vented, either be a suction source or to the atmosphere (¶0044-0045). Stringer teaches that such an active gas removal system employing a gas release valve advantageously facilitates the priming of the extracorporeal blood circuit with significantly less saline or donor blood, thereby reducing the time required for priming (¶0046). Modifying the system of Petralia so that it includes a gas release valve like the one taught by Stringer would therefore facilitate the priming of the medical fluid system with significantly less operating fluid and reduce the time required for priming as taught by Stringer. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Petralia so that it includes a gas release valve configured to permit gas to pass therethrough and prevent fluid from passing therethrough in order to enable priming the system with less operating fluid and reduce the time required for priming as taught by Stringer.
Regarding claims 2-3, Petralia in view of Stringer suggests the system of claim 1, and Petralia further discloses that the fluid reservoir (Figs. 1-2, feat. 3) further comprises a one-way baffle (Fig. 2, feat. 10; ¶0031-0034: de-bubbler 10 allows operating fluid to pass from the second connector 6a to the first connector 5a without allowing gasses to pass, and is therefore a one-way baffle as discussed on Page 10, line 25 – Page 11, line 31 of the present specification) disposed between the second connector (6a) and the first connector (5a), with respect to claim 2, that the one-way baffle (10) permits fluid to flow therethrough from a second connector side (6a) toward a first connector side of the one-way baffle (5a; ¶0031-0034), with respect to claim 3.
Regarding claim 4, Petralia in view of Stringer suggests the system of claim 3. Petralia discloses that the gas release duct (Fig. 2, feat. 7, 7a) is on the upstream side of the one-way baffle (10; ¶0031-0034). Therefore, because the system suggested by Petralia in view of Stringer has the gas-release valve on the gas release duct, Petralia in view of Stringer further suggests that the gas release valve is upstream of the one-way baffle.
Regarding claim 5, Petralia in view of Stringer suggests the system of claim 3. Petralia further discloses that the one-way baffle (Fig. 2, feat. 10; ¶0031-0034) has a one-way valve (8; ¶0024-0029) within it and around the port of the second connector (6a) that causes the operating liquid to only flow from the second connector to the reservoir downstream of it (3), and therefore to the first connector (5a), but not vice-versa (¶0024). Therefore, Petralia further discloses that the one-way baffle permits fluid to flow therethrough only from the second connector side of the one-way baffle toward the first connector side of the one-way baffle.
Regarding claim 6, Petralia in view of Stringer discloses the system of claim 1, and Petralia further discloses that the fluid reservoir (Fig. 2, feat. 3) is configured to recirculate fluid from the sterile fluid source through the medical fluid system fluidly coupled thereto (¶0043-0051).
Regarding claim 7, Petralia in view of Stringer discloses the system of claim 1. As discussed above, the blood filter for gas removal of Stringer (Figs. 1-2B, feat. 40) comprises a fluid inlet (42), a fluid outlet (43), a sensor (45), and a gas removal port (44) coupled to a valve (36; ¶0033-0036 and 0043-0045). Stringer teaches that the filter vents gasses to the atmosphere if placed downstream of a blood processing unit (31; ¶0045), which includes an oxygenator, pump, and pump motor (¶0029). In the system of Petralia, an oxygenator and pump are upstream of the second connector and outflow line (Petralia: Fig. 2, feat. 6, 6a; ¶0023), which is upstream and outputs fluid to the reservoir (Petralia: 3), and placing the filter for gas removal of Stringer downstream of the oxygenator and pump would cause it to be upstream from the reservoir. Therefore, Petralia in view of Stringer further suggests that the gas release valve is configured to vent gas to atmosphere and direct fluid into the fluid reservoir.
Regarding claims 8-9, Petralia in view of Stringer discloses the system of claim 1, and Petralia further discloses that the system further comprises a fluid supply line (Fig. 2, feat. 4a; ¶0018-0022) extending from the first fluid connector (4) to the fluid reservoir (Fig. 2, feat. 3), with respect to claim 8, and that the medical fluid system comprises a fluid pump and an oxygenator (¶0023), with respect to claim 9.
Regarding claim 10, Petralia in view of Stringer discloses the system of claim 1. Stringer further teaches that saline may be used to prime the system and remove gas from it (¶0046). Therefore, Petralia in view of Stringer further discloses that the sterile fluid source is a saline bag.
Regarding claim 11, Petralia discloses a method of priming a medical fluid system (¶0043-0051), comprising: coupling a first connector (Fig. 2, feat. 5a; ¶0018-0022) of a fluid reservoir (3; ¶0019) with an inflow line (5) of the medical fluid system (¶0044); coupling a second connector (6a) of the fluid reservoir with an outflow line (6) of the medical fluid system (¶0044); coupling a first fluid connector with a sterile fluid source, wherein the first fluid connector is in fluid communication with the fluid reservoir (4, 4a; ¶0018-0022 and 0044); and elevating the sterile fluid source above the medical fluid system (¶0038: in use, the first zone 14 of the reservoir, which is connected with the sterile fluid source via the first fluid connector 4, is placed at the top of the system), thereby causing fluid from the sterile fluid source to flow through the fluid reservoir into the inflow line of the medical fluid system, and through the medical fluid system thereby pushing gas disposed therein downstream through the outflow line (¶0044-0051).
Petralia does not disclose that gas is pushed to a gas release valve configured to vent gas to atmosphere and direct fluid into the fluid reservoir.
As discussed above, Stringer teaches a blood filter for gas removal in an extracorporeal blood circuit (Figs. 1-2B, feat. 40) comprising a fluid inlet (42), a fluid outlet (43), a sensor (45), and a gas removal port (44) coupled to a valve (36; ¶0033-0036 and 0043-0045). The valve is operated in response to the detection of a the presence of a predetermined volume of gas by the sensor, and allows the collected gas to be vented, either be a suction source or to the atmosphere (¶0044-0045). Stringer teaches that such an active gas removal system employing a gas release valve advantageously facilitates the priming of the extracorporeal blood circuit with significantly less saline or donor blood, thereby reducing the time required for priming (¶0046). Modifying the method of using the system of Petralia so that it includes a gas release valve like the one taught by Stringer would therefore facilitate the priming of the medical fluid system with significantly less operating fluid and reduce the time required for priming as taught by Stringer. Stringer teaches that the filter vents gasses to the atmosphere if placed downstream of a blood processing unit (31; ¶0045), which includes an oxygenator, pump, and pump motor (¶0029). In the system of Petralia, an oxygenator and pump are upstream of the second connector and outflow line (Petralia: Fig. 2, feat. 6, 6a; ¶0023), which is upstream and outputs fluid to the reservoir (Petralia: 3), and placing the filter for gas removal of Stringer downstream of the oxygenator and pump would cause it to be upstream from the reservoir. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Petralia so that the gas is pushed to a gas release valve configured to vent gas to atmosphere and direct fluid into the fluid reservoir in order to enable priming the medical fluid system with less operating fluid and reduce the time required for priming as taught by Stringer.
Regarding claim 12, Petralia in view of Stringer discloses the method of claim 11, and Petralia further discloses recirculating the fluid in the fluid reservoir through the medical fluid system (¶0043-0051).
Regarding claim 13, Petralia discloses a system for priming a medical fluid system (Figs. 1-2, feat. 1; ¶0017-0022) comprising: a first adapter assembly comprising a first fluid connector (5a) configured to interface with a sterile fluid source (3; reservoir 3 may hold operating fluid, and is therefore a sterile fluid source) and a first connector configured to fluidly coupled with an inflow line of the medical fluid system (5; ¶0018-0023 and 0043-0051); and a second adapter assembly comprising a second fluid connector (6a) configured to interface with the sterile fluid source (3), a second connector configured to fluidly couple with an outflow line of the medical fluid system (6; ¶0018-0023 and 0043-0051).
Petralia does not disclose that the second adapter assembly comprises a gas release valve configured to permit gas to pass therethrough and prevent fluid from passing therethrough.
As discussed above, Stringer teaches a blood filter for gas removal in an extracorporeal blood circuit (Figs. 1-2B, feat. 40) comprising a fluid inlet (42), a fluid outlet (43), a sensor (45), and a gas removal port (44) coupled to a valve (36; ¶0033-0036 and 0043-0045). The valve is operated in response to the detection of a the presence of a predetermined volume of gas by the sensor, and allows the collected gas to be vented, either be a suction source or to the atmosphere (¶0044-0045). Stringer teaches that such an active gas removal system employing a gas release valve advantageously facilitates the priming of the extracorporeal blood circuit with significantly less saline or donor blood, thereby reducing the time required for priming (¶0046). Modifying the method of using the system of Petralia so that it includes a gas release valve like the one taught by Stringer would therefore facilitate the priming of the medical fluid system with significantly less operating fluid and reduce the time required for priming as taught by Stringer. Stringer teaches that the filter vents gasses to the atmosphere if placed downstream of a blood processing unit (31; ¶0045), which includes an oxygenator, pump, and pump motor (¶0029). In the system of Petralia, an oxygenator and pump are upstream of the second connector and outflow line (Petralia: Fig. 2, feat. 6, 6a; ¶0023), which is upstream and outputs fluid to the reservoir (Petralia: 3), and modifying the second adapter assembly to include the filter for venting gasses of Stringer would place it downstream of the oxygenator and pump as taught by Stringer. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Petralia so that the second adapter assembly includes a gas release valve configured to permit gas to pass therethrough and prevent fluid from passing therethrough in order to enable priming the system with less operating fluid and reduce the time required for priming as taught by Stringer.
Regarding claims 14-15, Petralia in view of Stringer suggests the system of claim 13. As discussed above, in the system suggested by Petralia in view of Stringer, the gas removal filter is downstream of the oxygenator and the pump and upstream of the reservoir. Because the second fluid connector interfaces with the sterile fluid source comprising the reservoir and the second connector interfaces with the outflow line of the medical fluid system comprising the oxygenator and pump, the gas removal filter of the modified system would be upstream of the second fluid connector and downstream of the second connector. Therefore, Petralia in view of Stringer further suggests that the gas release valve is disposed upstream of the second fluid connector, with respect to claim 14, and that the gas release valve is disposed between the second fluid connector and the second connector.
Regarding claim 16, Petralia in view of Stringer discloses the system of claim 1. As discussed above, the blood filter for gas removal of Stringer (Figs. 1-2B, feat. 40) comprises a fluid inlet (42), a fluid outlet (43), a sensor (45), and a gas removal port (44) coupled to a valve (36; ¶0033-0036 and 0043-0045). Stringer teaches that the filter vents gasses to the atmosphere if placed downstream of a blood processing unit (31; ¶0045), which includes an oxygenator, pump, and pump motor (¶0029). In the system of Petralia, an oxygenator and pump are upstream of the second connector and outflow line (Petralia: Fig. 2, feat. 6, 6a; ¶0023), which is upstream and outputs fluid to the reservoir (Petralia: 3), and placing the filter for gas removal of Stringer downstream of the oxygenator and pump would cause it to be upstream from the reservoir. Therefore, Petralia in view of Stringer further suggests that the gas release valve is configured to vent gas to atmosphere and direct fluid into the fluid reservoir.
Regarding claim 17, Petralia in view of Stringer discloses the system of claim 1,3 and Petralia further disclose that the medical fluid system comprises a fluid pump and an oxygenator (¶0023).
Regarding claim 18, Petralia in view of Stringer discloses the system of claim 13. Stringer further teaches that saline may be used to prime the system and remove gas from it (¶0046). Therefore, Petralia in view of Stringer further discloses that the sterile fluid source is a saline bag.
Regarding claim 19, Petralia discloses a method of priming a medical fluid system (¶0043-0051), comprising: coupling a first connector (Fig. 2, feat. 5; ¶0018-0022) of a first adapter assembly (Fig. 2, feat. 5, 5a) with an inflow line of the medical fluid system (¶0044); coupling a second connector (6) of a second adapter assembly (6,6a) with an outflow line of the medical fluid system (¶0044); coupling a first fluid connector (5a) of the first adapter assembly with a sterile fluid source (3; ¶0019); coupling a second fluid connector (6a) of the second adapter assembly with the sterile fluid source (3); and elevating the sterile fluid source above the medical fluid system (¶0038: in use, the first zone 14 of the reservoir, which is connected with the sterile fluid source via the first fluid connector 4, is placed at the top of the system), thereby causing fluid from the sterile fluid source to flow through the fluid reservoir into the inflow line of the medical fluid system, and through the medical fluid system thereby pushing gas disposed therein downstream through the outflow line (¶0044-0051).
Petralia does not disclose that gas is pushed to a gas release valve configured to vent gas to atmosphere and direct fluid into the sterile fluid source.
As discussed above, Stringer teaches a blood filter for gas removal in an extracorporeal blood circuit (Figs. 1-2B, feat. 40) comprising a fluid inlet (42), a fluid outlet (43), a sensor (45), and a gas removal port (44) coupled to a valve (36; ¶0033-0036 and 0043-0045). The valve is operated in response to the detection of a the presence of a predetermined volume of gas by the sensor, and allows the collected gas to be vented, either be a suction source or to the atmosphere (¶0044-0045). Stringer teaches that such an active gas removal system employing a gas release valve advantageously facilitates the priming of the extracorporeal blood circuit with significantly less saline or donor blood, thereby reducing the time required for priming (¶0046). Modifying the method of using the system of Petralia so that it includes a gas release valve like the one taught by Stringer would therefore facilitate the priming of the medical fluid system with significantly less operating fluid and reduce the time required for priming as taught by Stringer. Stringer teaches that the filter vents gasses to the atmosphere if placed downstream of a blood processing unit (31; ¶0045), which includes an oxygenator, pump, and pump motor (¶0029). In the system of Petralia, an oxygenator and pump are upstream of the second connector and outflow line (Petralia: Fig. 2, feat. 6, 6a; ¶0023), which is upstream and outputs fluid to the reservoir (Petralia: 3), and placing the filter for gas removal of Stringer downstream of the oxygenator and pump would cause it to be upstream from the reservoir. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Petralia so that the gas is pushed to a gas release valve configured to vent gas to atmosphere and direct fluid into the fluid reservoir in order to enable priming the medical fluid system with less operating fluid and reduce the time required for priming as taught by Stringer.
Regarding claim 20, Petralia in view of Stringer discloses the method of claim 19, and Petralia further discloses recirculating the fluid in the fluid reservoir through the medical fluid system (¶0043-0051).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781