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 Amendment
This office action is responsive to the amendment filed on December 19, 2025. As directed by the amendment: claims 1 and 3 have been amended and claims 18-20 have been added. Thus, claims 1-20 are presently pending in this application with claims 9-17 presently withdrawn.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed October 2, 2025.
Response to Arguments
Applicant's arguments filed December 19, 2025 have been fully considered but they are not persuasive.
Applicant argues on pg. 7 of the Remarks that the connector of Moser delimited in the previous rejection is not received within the receiving end portion of the outer housing, as required by the amended claim language. The examiner agrees that the original interpretation set forth in the previous rejection does not reasonably teach the limitation; however, using the a new interpretation of Moser, the examiner maintains that Moser discloses the amended claim, discussed in more detail below.
Applicant argues on pg. 8 that Mosler does not teach the limitations of claim 5. The examiner notes that these arguments are moot as the limitations are disclosed by the new interpretation set forth to Cofoid, as necessitated by the amendments of claim 1.
Applicant argues on pg. 9 of the Remarks that “As both the valve cap 22 and float valve element 20 of Cofoid are elements of Cofoid's check valve 12, applicant respectfully submits that the cited elements of Cofoid are not elements of the pending "purge valve assembly" beyond that of "a check valve" included within the pending "purge valve assembly"”. The examiner notes that the term “valve” is a broad term and the claim does not impart any structure to the claimed valve. Merriam-Webster defines the term “valve” as “any of numerous mechanical devices by which the flow of liquid, gas, or loose material in bulk may be started, stopped, or regulated by a movable part that opens, shuts, or partially obstructs one or more ports or passageways; also : the movable part of such a device”. As such, as the claim does not further define the valve and the specification does not provide a special definition, the examiner maintains that it is reasonable to interpret the valve element (120) of Cofoid as being a “valve”. Using the definition of Merriam-Webster, the valve element is the movable part of a device which regulates the flow of fluid.
Applicant argues on pg. 9 of the Remarks that “the float valve element 20/"check valve" is not housed within the valve cap 22/"outer housing" but instead moves freely between a resting position on the valve cap 22/"outer housing" and out of the resting position in response to fluid being present”. The examiner respectfully asserts that the term “housed” does not necessitate a fixed position and, therefore, does not preclude a valve which is movable within an outer housing. The examiner agrees that valve cap 22 does not reasonably teach a check valve housed therein; however, the examiner maintains that using a different interpretation of the “outer housing”, Cofoid discloses the newly amended claim limitation, discussed in more detail below.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 4, 7, 18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moser (US 20110087164).
Regarding claim 1, Moser discloses a system (fig. 2B) comprising:
an intravenous fluid bag (paragraphs 5 and 92 discloses an IV bag can be attached to the piercing ends);
a tubing line assembly (syringe 115 in fig. 4B) including tubing (luer tip of the syringe 115 in fig. 4B) connected to a connector (see below);
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a purge valve assembly including a spike (see below) and an outer housing (cylindrical housing 99 in fig. 1) wherein the outer housing is connected to the connector (fig. 2B), wherein the outer housing includes a receiving end portion configured to receive the connector within the receiving end portion (see below; the portion below receives a portion of connector below); wherein the purge valve assembly further includes a check valve housed within the outer housing (check valve 120 in fig. 2B is shown to be fully housed within outer housing below).
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Regarding claim 4, Mosler discloses the check valve is a duckbill style check valve (valve 120 in fig. 2B is a duckbill valve).
Regarding claim 7, Mosler discloses the check valve is a one-way valve restricting fluid from passing from the tubing line assembly to the fluid bag (paragraph 92 discloses a one-way fluid direction from first piercing member 102 to second piercing member 104).
Regarding claim 18, Moser discloses the connector is a second spike (second piercing member 104 in fig. 2B).
Regarding claim 20, Moser discloses the spike includes a tip extending in a first direction and the connector includes a tip extendable within the receiving end portion in the first direction (see below, the tips both extend in the longitudinal direction; the term “tip” is interpreted to mean “a small piece or part serving as an end, cap, or point” as defined by Merriam-Webster).
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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) 1, 2, 5, 6, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cofoid (US 3465784) in view of Giuliano (US 20050059952).
Regarding claim 1, Cofoid discloses a system (fig. 1) comprising:
an intravenous fluid container (solution bottle 11 in fig. 1);
a tubing line assembly including tubing (feed tube 13 in fig. 1) connected to a connector (plunger 30 in fig. 1 is fluidically connected to the tubing 13);
a purge valve assembly including a spike (cap 15 and projection 17 form the “spike” in fig. 1) and an outer housing (cylinder 14 in fig. 1); wherein the outer housing is connected to the connector (cylinder 14 in fig. 1 is fluidically coupled to plunger 30), wherein the outer housing includes a receiving end portion configured to receive the connector within the receiving end portion (portion delimited by dotted line below, the bottom most part of cylinder 14; the portion below receives at least a top portion of the plunger 30 therethrough); wherein the purge valve assembly further includes a check valve housed within the outer housing (valve element 20 in fig. 1 is shown to be fully housed within cylinder 14 and is held within the cylinder due to caps 15 and 22; see response to arguments above).
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However, Cofoid does not teach or disclose the intravenous fluid container is a bag.
Giuliano teaches an intravenous fluid container in the form of a bag (bag 10 in fig. 1). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the container of Cofoid to be a bag, as taught by Giuliano, since Giuliano teaches that this type of container is a universal container for intravenous fluids (paragraph 41). Additionally, since Giuliano teaches that the bag is flexible (paragraph 41), this modification would enable easier storage in comparison to a rigid container.
Regarding claim 2, in the modified system of Cofoid, Cofoid discloses the check valve is positioned within an interior housing (cap 22 in fig. 1; valve element 20 in fig. 1 is shown to be partially positioned within cap 22 when the valve is in the descended/closed position).
Regarding claim 5, in the modified system of Cofoid, Cofoid discloses the spike includes a tip (projection 17 in fig. 1) extending from a base (cap 15 in fig. 1), wherein the base can be inserted within the outer housing (a portion of the base is shown to be inserted into cylinder 14 in fig. 1).
Regarding claim 6, in the modified system of Cofoid, Cofoid discloses a fluid path can be formed from the fluid bag, through the purge valve assembly and to the tubing line assembly (2:31-57 discloses that fluid flows from the container, through cylinder 14, past valve 20 , through passageway 22 and into the feed line 13).
Regarding claim 8, in the modified system of Cofoid, Giuliano discloses the fluid bag is made of a flexible material (paragraph 41).
Regarding claim 19, in the modified system of Cofoid, Cofoid discloses a second protrusion of the interior housing is at least partially positionable within the receiving end portion of the outer housing (see below; the rim designated below protrudes upwards so as to be a “protrusion”).
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Regarding claim 20, in the modified system of Cofoid, Cofoid discloses the spike includes a tip extending in a first direction and the connector includes a tip extendable within the receiving end portion in the first direction (see below, both tips below extend longitudinally; the term “tip” is interpreted to mean “a small piece or part serving as an end, cap, or point” as defined by Merriam-Webster).
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Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mosler, as applied to claim 1 above, and further in view of Miyoshi (US 6551299).
Regarding claim 2, Mosler discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the check valve is positioned within an interior housing.
Miyoshi is directed towards a similar device (fig. 6) comprising a check valve (check valve 28 in fig. 6) which is positioned within an outer housing (see below) and an interior housing (vent hole 26 in fig. 6). Miyoshi teaches that this arrangement further comprises a filter (filter 27 in fig. 6) and serves as a venting means (3:62-4:9)
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Since Mosler teaches a similar arrangement having a filter arranged in the outer housing (filter 108 in fig. 3B), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the system of Mosler to include an additional check valve positioned within an interior housing, as taught by Miyoshi. Miyoshi teaches that this arrangement prevents medical solution from flowing into the vent and through a gas passage (3:67-4:5).
Regarding claim 3, in the modified system of Mosler, Miyoshi discloses a first protrusion of the interior housing is at least partially positioned within a fluid conduit of the spike (see below; the protruding portion of the vent hole 26 is positioned within the passage below, which is a fluid passage of the spike; the examiner notes that the present claim language does not require that the protrusion be positioned within the spike). The examiner notes that modified with Miyoshi, the first protrusion would be positioned within vent conduit (105 in 2B) which is similarly a fluid conduit of the spike.
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Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mosler, as applied to claim 1 above, and further in view of Giuliano.
Regarding claim 8, Mosler discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the fluid bag is made of a flexible material.
As discussed above, Giuliano is directed towards an intravenous fluid bag (bag 10 in fig. 1) which is made of a flexible material (paragraph 41). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the fluid bag of Mosler to be made from a flexible material, as taught by Giuliano, since Giuliano teaches that this type of bag is universal (paragraph 41).
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 COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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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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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783