DETAILED ACTION
Response to Amendment
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/9/2026 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 7, 9-10, and 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evans (US 5,466,228).
In regard to claim 1, Evans discloses an apparatus, comprising: a central interface member (50) comprising a cavity (space inside 50) surrounded by an outer wall (52), a plurality of access points (62, 62, 66, 68) formed through respective surfaces of the outer wall (see at least Figs. 2A-2F); an infusion port (61) comprising a first end and a second end (61 is a tubular extension with two ends), the first end of the infusion port coupled to a first access point (62) of the plurality of access points; a saline port (63) comprising a first end and a second end (63 is a tubular extension with two ends), the second end of the saline port coupled to a second access point (64) of the plurality of access points, such that a first passageway is formed between the saline port and the infusion port through the cavity of the central interface member (see Fig. 2E; a path is defined between 61 and 63); and a drug product port (67) comprising a first end and a second end (67 is a tubular extension with two ends), the second end of the drug product port coupled to a third access point (68) of the plurality of access points, such that a second passageway is formed between the drug product port and the infusion port through the cavity of the central interface member (see Fig. 2C; a path is defined between 67 and 61), wherein the central interface member (50) comprises an expandable chamber (30; collection bag) (the claim is broad enough so that interface member can include chamber 30)..
***Examiner NOTE: the claims are broad enough that any of the ports (61, 63, 65, 67) can be interpreted interchangeably as the “infusion port”, “saline port”, and “drug product port”. Terms such as “infusion”, “saline”, and “drug product” are interpreted as intended use limitations and do not impart any particular structure to the claims.
In regard to claim 2, Evans discloses wherein the central interface member (50), the infusion port (61), the saline port (63), and the drug product port (67) comprise a single molded component (see Figs. 2A-F; element 50 defines all of the ports).
In regard to claim 3, Evans discloses wherein the second end of the infusion port (61) is configured to connect to an intravenous administration set (61 connects to tubing 40 and therefore has the capability to connect to an IV administration set).
In regard to claim 4, Evans discloses wherein the infusion port (61) is configured to deliver saline and drug product to a patient via the intravenous administration set (61 connects to tubing 40 and therefore has the capability to connect to an IV administration set).
In regard to claim 5, Evans discloses wherein the first end of the saline port (63) is configured to be coupled to a saline source (functional limitation), wherein the saline port is configured to deliver saline from the saline source through the cavity of the central interface member to the infusion port (see Fig. 2E).
In regard to claim 7, Evans discloses wherein the first end of the drug product port (67) is configured to be coupled to a drug product source (functional limitation), wherein the drug product port is configured to deliver drug product from the drug product source through the cavity of the central interface member to the infusion port (see Fig. 2C).
In regard to claim 9, Evans discloses wherein the drug product source comprises a syringe (the drug product source is functionally recited).
In regard to claim 10, Evans discloses wherein the drug product source comprises at least one vial (the product source is functionally recited), wherein the first end of the drug product port comprises at least one vial adaptor configured to engage with a respective one of the at least one vial, wherein the drug product flows from the at least one vial and the at least one vial adaptor into the cavity of the central interface member.
In regard to claim 12, Evans discloses further comprising: movable conduits (84, 85, 86, 87) contained within the cavity of the central interface member (see Figs. 2A-2F), the movable conduits configured to interface with the plurality of access points to form a plurality of passageways between the plurality of access points (see Figs. 2A-2F); wherein the movable conduits are configured to move between at least a first position and a second position (see Figs. 2A-2F), wherein in the first position the movable conduits interface with the plurality of access points such that the first passageway is defined between the second access point and the first access point to provide fluid connection between the saline port and the infusion port (see Figs. 2A-2F), and wherein in the second position the movable conduits interface with the plurality of access points such that the second passageway is defined between the third access point and the first access point to provide fluid connection between the drug product port and the infusion port (see Figs. 2A-2F).
In regard to claim 13, Evans dislcoses further comprising a control member (91) coupled to the movable conduits and configured to rotate the movable conduits between the first position and the second position (see Figs. 2A-2F).
In regard to claim 14, Evans discloses wherein the saline port (63) is configured to deliver saline from a saline source through the first passageway to the infusion port (functional limitation; see Fig. 2E).
In regard to claim 15, Evans discloses, wherein the drug product source comprises a vial (the product source is functionally recited), wherein the first end of the drug product port comprises a vial adaptor (67 is capable of attaching to a vial), the vial adaptor configured to engage with the vial such that the drug product flows through the second passageway to the infusion port.
In regard to claim 16, Evans discloses further comprising: a flush port (65) comprising a first end and a second end, the second end of the flush port coupled to a fourth access point (68) of the plurality of access points of the central interface member; wherein in the second position, the movable conduits interface with the plurality of access points such that a third passageway is defined between the second access point and the fourth access point to provide fluid connection between the saline port and the flush port (see Figs. 2A-2F).
In regard to claim 17, Evans discloses wherein the first end of the flush port (65) is configured to be coupled to a drug product source such that saline flows through the third passageway to the drug product source (the drug product source is functionally recited; the flush port is capable of connecting to a drug product source).
In regard to claim 18, Evans discloses wherein the drug product source (drug product source is functionally recited) comprises a chamber in which an infusion volume of a drug product is contained.
In regard to claim 19, Evans discloses wherein the first end of the flush port (65) is coupled to an upper portion of the chamber (the drug product source is functionally recited), wherein the first end of the drug product port is coupled to a lower portion of the chamber.
In regard to claim 20, Evans discloses wherein the chamber is configured to be coupled to a vial from which the chamber receives the infusion volume of the drug product (the drug product source and vial are functionally recited).
Claim Rejections - 35 USC § 103
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.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Becton Dickinson Co (EP 2566570; hereafter Becton).
In regard to claim 6, Evans fails to disclose wherein the saline port is terminated with a spike.
However, the provision of a port with a spike is a well-known measure for the skilled artisan wishing to improve the coupling capabilities of the apparatus. In a similar art, Becton discloses a chamber (40) with a port that is terminated with a spike (30) for coupling with a bag (12).
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 Evans with a spike as disclosed by Becton in order to provide a predictable configuration for coupling to a bag or other fluid source.
Response to Arguments
Applicant's arguments filed 7/9/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Evans fails to disclose or suggest a central interface member comprising an expandable chamber, the examiner respectfully disagrees. The applicant argues the central interface member comprises a cavity and a plurality of access points. The applicant concedes that Evans includes a cavity (inside of 50) and access points but argues that the identified expandable chamber (30) is separate and distal from the identified central interface member (50) so Evans does not disclose a central interface member with an expandable chamber. This argument is not persuasive. There is no limitation in the claim which requires the central interface member to be monolithically formed to prevent multiple components from being interpreted as the central interface member. There is also no physical structure recited in the claim which prevents element (30) from being included in the interpretation of the central interface member. There is no requirement that the central interface member has to include a central interface member within the recited cavity. For these reasons, the examiner maintains that the interpretation of central interface member as including element (30) and any intervening structure is within the broadest reasonable interpretation.
In response to the applicant’s argument that Evans fails to disclose the limitations of claims 10 and 12, the examiner respectfully disagrees. The claims require a port which is the structure at the end of the tubes of Evans. These ports are capable of engaging with the functionally recited limitations in claims 10 and 12.
Conclusion
THIS ACTION IS MADE FINAL. 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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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