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 .
Election/Restrictions
Applicant’s election without traverse of Species 300 (*should have corresponded to Species C; the restriction requirement inadvertently labeled all of the species as “A”) in the reply filed on 2/9/2026 is acknowledged.
Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/9/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/17/2023 and 10/1/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are 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, and 9-20 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).
***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 11, Evans discloses 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).
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.
Conclusion
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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