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 .
Response to Arguments
Applicant's arguments filed 7/23/2026 have been fully considered.
Regarding claim 1, Applicant argues that Cook fails to teach a standalone IV bag without a required housing. This argument is convincing as Cook discloses a housing element surrounding the bag. Applicant further argues that Chi also discloses a housing surrounding the bag. Therefore, the rejection is withdrawn. However, upon further consideration in light of the amendments to the claims, a new rejection is made in view of Wang (CN 107374961 A).
Information Disclosure Statement
IDS filed 6/11/2026 has been considered. The IDS cites an EPO office action which has been considered. However, the documents cited on that EPO document have not been themselves cited in this application and therefore will not be part of the record. These documents should be explicitly cited on an IDS to be made part of the record.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 has been amended to recite “a fluid reservoir comprising a standalone IV bag separate from a housing”. This limitation appears to positively recite a housing, the housing being separate from the IV bag. However, based on the disclosure and Applicant’s arguments submitted with this response, it appears as though the instant invention does not include a housing at all. For the purposes of this examination, this is interpreted to be a negative limitation wherein a housing is not associated with the claimed invention, however appropriate correction is required.
Claim 17 includes a limitation similar to that describe above and therefore is rejected for similar reasons.
Dependent claims inherit the deficiencies of the claims from which they depend.
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, 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (CN 107374961 A) in view of Chi et al (US 2014/0276427). For ease of discussion, please refer to machine translation of Wang obtained from WIPO provided herewith.
Regarding claim 1, Wang discloses an intravenous (IV) pressure assembly (fig. 1) comprising: a fluid reservoir comprising a standalone IV bag 1 separate from a housing and containing a medical fluid (page 2) and a pressure assembly including a connector 6 coupled directly with a fluid passageway into the fluid reservoir (fig. 1; page 2).
Wang discloses a pressure assembly, but fails to disclose the specific arrangement of the pressure source. Chi teaches an IV pressure assembly wherein the pressure assembly comprises a body 120, an 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 device of Wang to include a pressure assembly as described by Chi including 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, Wang discloses that a pressurized gas suitable for intermingling with the medical fluid within the fluid reservoir is provided to the fluid reservoir (page 2: helium). 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 device of Wang to include helium in the pressurized gas container in the combination described above for the purpose of providing a gas to pressurize the bag.
Regarding claim 3, Wang in view of Chi as discussed above with regard to claim 1 includes a pressurized container that is configured to introduce a pressure differential into the fluid reservoir. Wang further teaches that the gas delivered to the reservoir is helium which does not interact with blood and will not dissolve into blood under atmospheric pressures.
Regarding claim 4, Wang in view of Chi as discussed above with regard to claim 1 includes a pressurized container. Wang further teaches that the gas is helium (page 2) which is suitable for intermingling with the medical fluid in the reservoir (blood).
Regarding claim 9, Chi teaches that the outlet port is configured as the connector (fig. 15).
Regarding claim 13, Wang discloses a seal 10 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 (page 2).
Regarding claim 14, Wang discloses that the valve allows for gas to be provided into the reservoir until the valve is closed, i.e., resealed (page 2).
Regarding claim 15, Wang discloses a valve 10 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 (page 2).
Regarding claim 16, Wang discloses that pressure is provided into the fluid reservoir though the fluid pathway when the valve is un the open position until the valve is returned to the closed position (page 2).
Regarding claim 17, Wang discloses an intravenous (IV) system (fig. 1) comprising an IV set comprising a fluid reservoir comprising a standalone IV bag 1 separate from a housing and containing a medical fluid (page 2), one or more IV components (IV bag 1 and valve 2), one or more IV tubes 3 (page 2) and a pressure assembly including a connector 6 coupled directly with a fluid passageway into the fluid reservoir (fig. 1; page 2), the pressure assembly configured to force fluid within the IV bag into the IV set at a fluid flow rate exceeding a maximum gravity based fluid flow rate (page 2).
Wang discloses a pressure assembly, but fails to disclose the specific arrangement of the pressure source. Chi teaches an IV pressure assembly wherein the pressure assembly comprises a body 120, an 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 device of Wang to include a pressure assembly as described by Chi including 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.
Claim(s) 5, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang 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, Wang 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 Wang 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 Wang 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 Wang 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 Wang 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 Wang 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 Wang 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) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Chi as applied to claim 1 above, and further in view of Lo (US 4,048,994).
Claim 10 differs from Wang 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 Wang 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, Wang discloses that the pressurized container is configured to provide consistent pressure into the container (page 2). Wang 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, Wang discloses a valve 10 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 (page 2).
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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