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 .
Status of the Claims
Claims filed 12/05/2024 has been entered. Claims 1-12 are pending and under consideration.
Claim Objections
Claims 8 and 9 are objected to because of the following informalities:
Claim 8 line 2 recites “the one-way check valve” which should read “ the one-way valve”
Claim 9 line 1 recites “the one-way check valve” which should read “ the one-way valve”
Appropriate correction is required.
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.
Claims 1-3, 6-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Pennington (US 3822700 A) in view of Browka et al (US 20150250680 A1).
Regarding claim 1, Pennington substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
A transfer device, the transfer device comprising a three-way connector body (figures 1-2, body 10 provides three-way connector through spike 16, injection nipple 34 and flange 14) having:
i) a vial adapter (figures 1-2, injection nipple 34 + air inlet nipple 28 coupled to body 10) coupled to the three-way connector body for receiving a media container with a stopper, the vial adapter including a vial spike for fluidic communication therewith, the vial spike comprising at least one vial spike lumen (figure 2, passageway 36), a distal annular edge connected to the vial adapter by four segments defining four openings, and four fingers positioned within the four segments;
ii) an IV spike (figure 2, spike 16) integral with the three-way connector body, the IV spike having a first end (figure 2 col 3 lines 42-55, pint end 18 for insertion into container) for insertion into an infusion liquid container, and a second end (figure 2, flange are 14 for receiving drip chamber 22 + tubing 24) for receiving an infusion port (figure 2, drip chamber 22 + tubing 24), a first IV lumen (figure 2, passageway 26), and a second IV lumen (figure 2, passageway 20) adjacent the first IV lumen, the first IV lumen being in direct fluid communication with the at least one vial spike lumen (figure 2, passageway 26 is extended to passageway 36 and they are being in direct fluid communication ), and the second IV lumen being in direct fluidic communication to the infusion port (figure 2 and col 3 lines 20-29, the conduit 20 is extend and opens into drip chamber 22 and tubing 24), through the three-way connector body, the first IV lumen and the second IV lumen being isolated from each other (figure 2, the passageways 26 and 20 are physically isolated by central wall).
Pennington does not teach the adapter is being a vial adapter for receiving a media container with a stopper, the adapter including a vial spike for fluidic communication therewith, and a distal annular edge connected to the vial adapter by four segments defining four openings, and four fingers positioned within the four segments.
In the same field of endeavor, namely a transfer device with fluid filter, Browka teaches the adapter is being a vial adapter (figures 1-17 and [0006], device 100 is configured to be coupled to a vial with a septum) for receiving a media container with a stopper, the adapter including a vial spike (figure 2b, spike 106) for fluidic communication therewith, and a distal annular edge (figure 3b or 9c, shroud 126 or ring 324 connected to device 100) connected to the vial adapter by four segments defining four openings (figure 9c, shroud 126 or ring 324 connected to body 311 by four segments including fingers 327 and projecting finger element 325a, space between the fingers 327 define four openings), and four fingers positioned within the four segments.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pennington to incorporate the teachings of Browka and provides the vial adapter as claimed for the purpose of providing a direct fluid path between delivery device, i.e., IV bag, to the vial for reconstitution of the medicament as taught by Browka ([0001-0006]). Doing so would eliminate the need to use a separate delivery device, such as a syringe, to withdraw and deliver the diluent to the vial, which reduces the number of handling and transfer steps, and prevent accidental exposure of the medicament during preparation.
Regarding claim 2, Pennington, as modified by Browka, teaches the transfer device of claim 1.
The combination further teaches wherein the second IV lumen is isolated from the first IV lumen throughout the three-way connector body (Pennington; figure 2, the passageway 20 and 26 are isolated throughout the body 10).
Regarding claim 3, Pennington, as modified by Browka, teaches the transfer device of claim 1.
The combination further teaches wherein the vial adapter is integral with the three-way connector body (Pennington; the nipple 34 is integral with the body 10).
Regarding claim 6, Pennington, as modified by Browka, teaches the transfer device of claim 1.
The combination further teaches wherein the at least one vial spike lumen has at least two physically separated vial lumens (Pennington; figure 2, physically separated passageway 36 and passageway through air inlet nipple 28, Browka; figure 2b, 128 and 112).
Regarding claim 7, Pennington, as modified by Browka, teaches the transfer device of claim 6.
The combination further teaches wherein at least one of the at least two physically separated vial lumens is in direct fluid communication with at least one of a vent, a vent filter, a one-way valve, and a fluid filter (Pennigton; figure 2 col 3 line 30-38, the passageway through air inlet nipple in fluid communication with vent 28, Browka; vent conduit 128 in fluid communication with vent opening 105).
Regarding claim 8, Pennington, as modified by Browka, teaches the transfer device of claim 7.
The combination further teaches wherein the at least one of the at least two physically separated vial lumens are in direct fluid communication with the one-way check valve (Pennington; figure 2a, the passageway through the air inlet nipple in direct fluid communication with ball check valve 30).
Regarding claim 9, Pennington, as modified by Browka, teaches the transfer device of claim 8.
The combination further teaches wherein the one-way check valve is integral with the vial adapter (Pennington, the structure of the vial adapter the ball, i.e., passageway, integrally forms check valve 30 with the ball).
Regarding claim 11, Pennington, as modified by Browka, teaches the transfer device of claim 1.
The combination further teaches wherein the three-way connector body is coupled with an infusion set (Pennington; figure 2, the body 10 is coupled with drip chamber 22 and tubing 24).
Claims 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Pennington (US 3822700 A) in view of Browka et al (US 20150250680 A1), and in further view of Lev et al (US 20160166824 A1).
Regarding claim 4, Pennington, as modified by Browka, teaches the transfer device of claim 1.
The combination does not teach wherein the vial adapter is releasably coupled with the three-way connector body.
In the same field of endeavor, namely a liquid transfer device, Lev teaches wherein the vial adapter (figure 7 and [0028] vial adapter 18 is releasably coupled with liquid transfer device 121) is releasably coupled with the three-way connector body.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pennington, as modified by Browka, to incorporate the teachings of Lev and provides the vial adapter as claimed for the purpose of permitting the three-way connector body to be selectively accessed by different types of transfer device. For example, a syringe or another vial adapter can be coupled to the three-way connector body to facilitate transfer of infusion liquid from the IV bag or transfer of medicament to or from a vial as taught by Lev ([0002]). Furthermore, the releasable coupling provides the convenience of removing the vial adapter from the three-way connector body when the vial adapter is no longer needed.
Regarding claim 12, Pennington, as modified by Browka, teaches the transfer device of claim 1.
The combination does not teach further comprising an IV spike adapter coupled to the three-way connector body configured for receiving an IV set.
In the same field of endeavor, namely a liquid transfer device, Lev teaches comprising an IV spike adapter (figure 4 and [0043], infusion set 50 comprising IV spike 51 configured to be coupled to administration port 43 of liquid transfer device 101) coupled to the three-way connector body configured for receiving an IV set.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pennington, as modified by Browka, to incorporate the teachings of Lev and provides the IV spike adapter as claimed for the purpose of allowing a conventional IV set to be selectively connected to the three-way connector body, as taught by Lev ([0030-0033]). The separable configuration allows the IV set to be connected after completion of reconstitution of the medicament, rather than requiring the IV set to remain connected during the reconstitution procedure. This prevents unintended IV administration with delivery of prematurely reconstituted medicament.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Pennington (US 3822700 A) in view of Browka et al (US 20150250680 A1), and in further view of Proksch et al (US 20110004184 A1).
Regarding claim 5, Pennington, as modified by Browka, teaches the transfer device of claim 1.
The combination does not teach wherein the at least one vial spike lumen is configurable between:
a first configuration where the at least one vial spike lumen is in continuous fluid communication with the first IV lumen or second IV lumen; and
a second configuration, where, upon rotation of the vial adapter relative to the three-way connector body, the at least one vial spike lumen is in discontinuous fluid communication with the first IV lumen or the second IV lumen.
In the same field of endeavor, namely a device for introducing medicine into an infusion container, Proksche teaches a transfer device (figure 1, transfer cap 2) comprising a vial spike lumen (figure 3, lumen within spike 2.5) is configurable between:
a first configuration (figure 3a and [0043] open configuration) where the at least one vial spike lumen is in continuous fluid communication with the first IV lumen or second IV lumen (figure 3a and [0042]-[0043], rotating tubular cap 2.3 relative transfer cap 2 aligns through-channel 6.1 of valve 6 with the spike lumen 2.5 which sets the spike lumen in fluid communication with hollow spike 2.4) ; and
a second configuration (figure 3 and [0042] closed configuration), where, upon rotation of the vial adapter relative to the three-way connector body ([0042-0043] upon rotation of tubular hub 2.3 relative to transfer cap 2), the at least one vial spike lumen is in discontinuous fluid communication with the first IV lumen or the second IV lumen (figure 3 and [0042]-[0043], rotation of transfer cap set the valve in closed position which blocks fluid communication between spike lumen 2.5 and 2.4).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pennington, as modified by Browka, to incorporate the teachings of Proksch and provides the at least one vial spike lumen as claimed the purpose of providing selective fluid flow control between the IV spike and the Vial spike, which prevents contamination of IV fluid container when the vial is detached from the transfer device, as taught by Proksche ([0006-0007]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Pennington (US 3822700 A) in view of Browka et al (US 20150250680 A1), and in further view of Zinger et al (US 20070088313 A1).
Regarding claim 10, Pennington, as modified by Browka, teaches the transfer device of claim 1.
The combination does not expressly teach wherein the vent filter is hydrophobic.
In the same field of endeavor, namely a fluid transfer device, Zinger, teaches wherein the vent filter is hydrophobic (figure 29 and [0091] hydrophobic filter 92)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pennington, as modified by Browka, to incorporate the teachings of Zinger and provide the hydrophobic filter for the purpose of preventing spillage of medication through the vent, as taught by Zinger ([0091]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hanner et al (US 20170087297 A1) and Wallen et al (US 20030191445 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SETH HAN/Examiner, Art Unit 3781
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