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 § 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 and 9-11 and 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2012/0143150 to Page et al. (Page hereinafter).
Regarding claim 1, Page teaches an intravenous fluid delivery system comprising a multiple line portion (see e.g. 310, Fig. 3E), including a plurality of fluid lines (312, 314) connected to each other, and a mixing element (320, 333) at a downstream end with a single outlet (connected to 331) and having slots (316) in fluid communication with each line (312, 314). The examiner notes that the claimed mixing element is formed integrally with the ends of each line (312, 314), and further notes that a broadest reasonable interpretation of claim 1 includes this scope.
Regarding claim 2, Page teaches a central line (312) and peripheral lines (314).
Regarding claim 3, Page teaches that the peripheral lines are connected to an external wall of the central line (as in Fig. 3B).
Regarding claims 4 and 5, Page teaches detachable connections and separability of the peripheral lines (paragraph 87).
Regarding claim 9, Page teaches connectors (331) configured for respective connection to fluid lines.
Regarding claims 10 and 11, Page teaches that the respective fluid source may be a pump or a bag (paragraph 4).
Regarding claim 13, Page teaches a central slot (24).
Regarding claim 14, Page teaches that the peripheral slots (16) provide fluid to the central slot (24, see e.g. paragraph 89).
Regarding claim 15, Page teaches that the single outlet is formed by a distal end of the central slot.
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Page.
Regarding claim 6, Page teaches the limitations of claim 3 as discussed above, but does not teach the particular connection dimensions. However, Page does teach that the dimensions of the tubing are subject to normal design parameters and vary according to the application (paragraph 85). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to optimize the connection thickness of the tubing of Page for a given application resulting the in the claimed dimension as a mere design choice relating to the chosen application.
Claim(s) 7-8 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Page in view of US Pre-Grant Publication 2004/0158211 to Rogers et al. (Rogers).
Regarding claim 7, Page teaches the limitations of claim 1 as discussed above, but is silent as to the materials used for the tubing. Rogers teaches that at least thermoplastic polyurethanes (paragraph 43) are known for the production of medical tubing as being flexible and biocompatible. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use thermoplastic polyurethanes as taught by Rogers in the tubing of Page in order to achieve a flexible, biocompatible tubing.
Regarding claim 8, Page does not teach methods of forming the tubes. Rogers teaches co-extrusion of tubing (43) as a viable method of forming multiple lumen tubing. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use co-extrusion as taught by Rogers to form the multiple lumen tubing as the mere selection of a manufacturing method known in the field for producing the type of article at hand.
Regarding claim 16, Page does not teach an outlet tubing with a valve. Rogers teaches another intravenous fluid delivery system generally, and particularly teaches that a fluid source (90) may be coupled to a needle or catheter via an outlet tube (40, 80) with a valve (30) to prevent bloodborne pathogen exposure (paragraph 21). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a valved outlet tube as taught by Rogers in order to prevent bloodborne pathogen exposure. The examiner notes that the combination requires only the serial connection of the port (333) of Page to the valve (30) or outlet tube (80) of Rogers, and further notes that both references are cognizant of Luer type connections for such interfaces.
Regarding claims 17 and 18, Rogers teaches coupling to needles (via 50) or catheters (20).
Regarding claim 19, Rogers teaches a one-way valve (30) downstream of the outlet tube (80) configured to prevent fluid from flowing upstream, including to the mixing element in the combination.
Regarding claim 20, Rogers teaches a one-way valve (30) between the outlet tubing (at 40) and the mixing element of Page.
Response to Arguments
Applicant's arguments filed 9 September 2025 have been fully considered but they are not persuasive.
With respect to the argument that Page does not teach a mixing element with a plurality of slots, the examiner is not persuaded. In particular, the invention as claimed includes the scope of a mixing element which is integrally formed with the fluid lines. As such, the end (320) of the catheter as a whole is considered to constitute a mixing element as claimed and claim 1 is therefore still anticipated. The examiner further notes that the claimed slots read on any aperture between the carrier line (312) and the associated administration line (314).
In view of the above, the rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pre-Grant Publication 2010/0065660 teaches a mixing element (70, 80) with slots (between ridges 84) and a single outlet (76).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3746 12 December 2025
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