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 § 103
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 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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/106642 and further in view of Zinger et al. (US 2008/0262465).
With reference to claims 1 and 3, WO 2019/106642 (hereinafter “Fabrikant”) discloses a liquid transfer device (abstract), comprising:
an IV spike (102) configured to connect to an infusion liquid container (page 1, lines 5-6);
a compactable vial adaptor configured to mount onto a vial (page 10, lines 28-32);
an IV port (106) configured to connect to an infusion set (figure 4); and
a valve (118) movable between a first state and a second state upon compaction of the vial adaptor as discussed on page 10, lines 25-35.
Fabrikant describes a three rotation position stopcock arrangement that prevents all fluid communication in a first state and provides selective fluid communication in second and third states (page 11, lines 4-17) and anticipates 3 way flow communication as set forth on page 18, lines 33-35.
Zinger et al. (hereinafter “Zinger”) teaches an analogous valve that is configured to prevent fluid communication between the IV spike, the vial adaptor and the IV port in a first state, and is configured to provide fluid communication between the IV spike and the vial adaptor, and fluid communication between the IV spike and the IV port in the second state as set forth in the abstract.
It would have been obvious to one of ordinary skill in the art at the time of the invention to substitute the connector of Fabrikant with the connector as taught by Zinger in order to enable the transfer device to include a 3 way direct and continuous fluid communication for the benefits provided thereof as discussed by Zinger in the abstract.
As to claim 2, Fabrikant discloses a liquid transfer device wherein the IV spike comprises a first IV spike lumen and a second IV spike lumen configured to provide fluid communication with the infusion liquid container as set forth on page 1, lines 8-18 through the incorporation of WO 2015/019343 where Fabrikant discloses in [0003] that WO 2015/019343 includes three lumens.
Regarding claim 4, Fabrikant discloses a liquid transfer device wherein the valve comprises a first lumen configured to provide fluid communication between the first IV spike lumen and the vial adaptor, and a second lumen configured to provide fluid communication between the second IV spike lumen and the IV port as set forth on page 1, line 8 to page 2, line 4 through the incorporation of WO 2015/019343 and the recited steps.
With reference to claims 5 and 7, Fabrikant discloses a liquid transfer device wherein the vial adaptor comprises a vial spike to puncture a vial stopper of the vial to provide fluid communication with the vial as set forth on page 9, lines 29-30.
Regarding claim 6, Fabrikant discloses a liquid transfer device wherein the vial adaptor comprises an outer vial adaptor body (111) and an inner vial adaptor body (109) configured to mount onto a vial, wherein the inner vial adaptor body is configured to slide within the outer vial adaptor body when the vial adaptor undergoes compaction from a non-compacted state to a compacted state as set forth on page 10, lines 27-35.
As to claim 8, Fabrikant, through the incorporation of WO 2015/019343 in [0002], discloses a liquid transfer device further comprising a valve actuator movable between a first position and a second position, wherein the valve actuator is configured to move from the first position to the second position upon compaction of the vial adaptor as disclosed by WO 2015/019343.
With respect to claim 9, see the rejection of claim 1. Additionally, Fabrikant discloses a liquid transfer device wherein the valve actuator is configured to drive the valve from the first state when the valve actuator is in the first position to the second state when the valve actuator is in a second position upon compaction of the vial adaptor as set forth on page 11, lines 1-17.
As to claim 10, Fabrikant discloses a liquid transfer device wherein the valve comprises an angled face configured to engage with the valve actuator as shown in figures 6A-8A.
As to claim 11, Fabrikant discloses a liquid transfer device further comprising a safety catch which is configured to prevent compaction of the vial adaptor in the non-compacted state as set forth on page 11, lines 18-20.
Regarding claims 12-13, Fabrikant discloses a liquid transfer device further comprising a connector body having the IV spike, the vial adaptor and the IV port coupled thereto, wherein the valve is movable within the connector body between the first state and the second state and including a bore, a locking protrusion configured to function as claimed as set forth on pages 12-16.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELE KIDWELL/Primary Examiner, Art Unit 3781
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