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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/25/2026 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) 1-4, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook (US 2022/0233766) in view of Chi et al (US 2014/0276427).
Regarding claim 1, Cook discloses an intravenous (IV) pressure assembly (page 1, para. 0003; fig. 1A) comprising: a pressure source 106; and a connector 116 to the pressure source (fig. 1A), the connector configured to couple directly with a fluid pathway 126 into a fluid reservoir 104 (fig. 1A; page 2, para. 0025), wherein the fluid reservoir is an IV bag 104 containing a medical fluid (page 1, para. 0018), wherein the IV pressure assembly is configured as a pressurized container (abstract).
Cook discloses a pressure source, but fails to disclose that the pressure source includes a body; an outlet port disposed on the body; and a connector coupled to the outlet port. Chi teaches an IV pressure assembly wherein the pressure source 120 includes a body, and outlet port disposed on the body, and a connector 170 coupled to the outlet port (fig. 15). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure source of Cook to include a body having an outlet port and a connector coupled to the outlet port as taught by Chi to provide an air-tight means for conveying gas from the pressure source to the IV bag so that the pressure can be reliable applied.
Regarding claim 2, Cook discloses that the pressurized container contains a pressurized gas suitable for intermingling with the medical fluid within the fluid reservoir (page 2, para. 0025).
Regarding claim 3, Cook discloses that the pressurized container is configured to introduce a pressure differential into the fluid reservoir without introducing a gas into the medical fluid contained within the fluid reservoir (fig. 1A: gas is floating on the medical fluid 112).
Regarding claim 4, Cook is silent as to the particular pressurized fluid delivered from the fluid source. Chi teaches that the pressurized container contains a pressurized fluid suitable for intermingling with a medical fluid int eh reservoir (page 4, para. 0061: pressurized CO2). (Currently Amended) The IV pressure assembly of claim 1, wherein the pressurized container contains a pressurized fluid that is suitable for intermingling with [[a]] the medical fluid within the fluid reservoir. The limitation "suitable for intermingling with a medical fluid in the reservoir" is a functional limitation. The claim does not require that the gas actually intermingles with the medical fluid or that the device is arranged such that it is capable of doing so, rather the scope of the claim only requires that the gas is of the type that is suitable for such purposes. CO₂ is suitable for intermingling with a medical fluid. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressurized fluid of Cook to include CO-2 as taught by Chi because CO-2 is suitable for providing pressure to the medical fluid and is non-reactive.
Regarding claim 9, Chi teaches that the outlet port is configured as the connector (fig. 15).
Claim(s) 5, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook in view of Chi as applied to claim 1 above, and further in view of Lampropoulos et al (US 6,800,069).
Regarding claim 5, Cook in view of Chi shows the connector as discussed above with regard to claim 1, but fails to disclose that the connector is either a male or female luer connector. Lampropoulos teaches an IV pressure infusion system that includes connectors, wherein the connectors are corresponding male and female connectors (col. 7, lines 7-14; fig. 2). Luer connectors are known in the art to provide easy, secure, and leak-proof connections between components. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection of Cook in view of Chi to be a male or female luer connection as taught by Lampropoulos because luer connectors are secure and easy to assemble and provide leak free flow between the fluid components.
Claim 7 calls for the connector to be one of: a needleless connector configured to couple with a needleless port of the fluid reservoir; and a needleless port configured to couple with a needleless connector of the fluid reservoir. Lampropoulos teaches a luer connector as discussed above with regard to claim 5. A luer connector is a needless port. Therefore, claim 7 is rejected for the same reasons described above with regard to claim 5.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook in view of Chi as applied to claim 1 above, and further in view of Stinson (US 2019/0060114).
Claim 6 calls for the connector to be one of: a female snap connector configured to couple with a male snap connector of the fluid reservoir; and a male snap connector configured to couple with a female snap connector of the fluid reservoir. Chi shows the connector but does not disclose the type. Stinson teaches that a connection between a tube and an IV reservoir may be of any known type including male and female snap and lock design to provide a fluid tight connection between the two elements (pages 2-3, para. 0033). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection of Cook in view of Chi to be a male or female snap connector as taught by Stinson because Stinson teaches that any known type of connection is suitable for providing a fluid connection between an IV reservoir and a tube including a male and female snap connector.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook in view of Chi as applied to claim 1 above, and further in view of Vest et al (US 6,899,702).
Claim 8 differs from Cook in view of Chi in calling for the connector to a spike configured to penetrate the fluid reservoir instead of coupling to an opposing connector. Vest teaches a connection between a fluid tubing and an IV fluid container wherein the connector is a spike which provides fluid tight connection and maintains sterility of the reservoir prior to connection (col. 3, lines 2-6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector of Cook in view of Chi to be a spike as taught by Vest to provide a fluid tight seal with the reservoir and to ensure that the contents of the reservoir remain sterile prior to use.
Claim(s) 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook in view of Chi as applied to claim 1 above, and further in view of Lo (US 4,048,994).
Claim 10 differs from Cook in view of Chi in calling for the pressurized container to be configured to open a fluid flow pathway between the IV pressure assembly and the fluid reservoir upon coupling of the connector to the fluid reservoir. Lo teaches a pressurized IV system including a pressurized container that is configured to open a fluid flow pathway between the IV pressure assembly and the fluid reservoir upon coupling of the connector to the reservoir via a one way valve (col. 3, lines 6-11). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Cook in view of Chi such that the pressurized container opens a fluid pathway between the pressure assembly and the fluid reservoir upon coupling the connector to the reservoir via a one way valve as taught by Lo to allow the pressurized gas to enter the reservoir, but not exit the reservoir so that the pressure can be applied to the fluid to cause delivery of the fluid out of the reservoir.
Regarding claim 11, Cook discloses that the pressurized container is configured to provide consistent pressure into the container (page 2, para. 0026). Cook in view of Chi does not specifically disclose that the pressure is provided until one of: a pressurized fluid in the pressurized container is depleted; and the connector is uncoupled from the fluid reservoir, however, it would have been apparent to a person of ordinary skill in the art that this is how the device operates as the container is not refillable meaning that the pressure is provided until the container is depleted, and also upon disconnection of the container from the reservoir the container can no longer provide pressure to the reservoir.
Regarding claim 12, Lo teaches that the fluid path includes a valve configured to block a fluid flow pathway between the IV pressure assembly and the fluid reservoir when the connector is coupled to the fluid reservoir and the valve is in a closed position to prevent reverse flow of the gas out of the reservoir. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include this feature in the combination described above with regard to claim 10 as taught by Lo to prevent the gas from leaking out of the container.
Claim 13 differs from Cook in view of Chi in calling for a seal configured to block a fluid flow pathway between the IV pressure assembly and the fluid reservoir when the connector is coupled to the fluid reservoir. Lo teaches a pressurized IV system including a pressurized container and further comprising a seal (valve) that blocks a fluid pathway between the IV pressure assembly and the fluid reservoir when the connector is coupled to the reservoir (col. 3, lines 6-11). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Cook in view of Chi to include a seal as claimed as taught by Lo to allow the pressurized gas to enter the reservoir, but not exit the reservoir so that the pressure can be applied to the fluid to cause delivery of the fluid out of the reservoir.
Regarding claim 14, Cook in view of Chi discloses that the pressurized container is configured to provide consistent pressure into the container (Cook: page 2, para. 0026; Chi: pages 4-5, para. 0067). Cook and Chi do not specifically disclose that the pressure is provided until one of: a pressurized fluid in the pressurized container is depleted; and the connector is uncoupled from the fluid reservoir, however, it would have been apparent to a person of ordinary skill in the art that this is how the device operates as the container is not refillable meaning that the pressure is provided until the container is depleted, and also upon disconnection of the container from the reservoir the container can no longer provide pressure to the reservoir.
Claim 15 differs from Cook in view of Chi in calling for a valve configured to block a fluid flow pathway between the IV pressure assembly and the fluid reservoir when the connector is coupled to the fluid reservoir and the valve is in a closed position. Lo teaches a pressurized IV system including a pressurized container and a valve in a fluid flow pathway between the IV pressure assembly and the fluid reservoir to block the fluid flow pathway when the connector is coupled to the reservoir and the valve is in the closed position (col. 3, lines 6-11). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Cook in view of Chi to include a valve as taught by Lo to allow the pressurized gas to enter the reservoir, but not exit the reservoir so that the pressure can be applied to the fluid to cause delivery of the fluid out of the reservoir.
Regarding claim 16, in the combination described above with regard to claim 15, the pressurized container is configured to provide pressure into the fluid reservoir through the fluid flow pathway when the valve is adjusted to one of a partially open position and a fully open position (Lo col. 3, lines 6-11). Cook in view of Chi does not specifically disclose that the pressure is provided until one of: the valve is adjusted back to a closed position; a pressurized fluid in the pressurized container is depleted; and the connector is uncoupled from the fluid reservoir. However, it would have been apparent to a person of ordinary skill in the art that this is how the device operates as the container is not refillable meaning that the pressure is provided until the container is depleted, and also upon disconnection of the container from the reservoir the container can no longer provide pressure to the reservoir.
Allowable Subject Matter
Claims 18, 20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: see prior Office actions for reasons for allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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