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 Objections
Claim 11 is objected to because of the following informalities: In line 2, “reach” should be “each”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: In lines 6 and 7, “the respective first manifold outlet” should be “the respective each first manifold outlet”. 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.
Claim(s) 1-7, 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Phallen (2015/0114515; cited prior art) in view of Kjar (9481477).
Regarding claim 1, the Phallen reference discloses a fluid distribution system (Figure 6) comprising:
a manifold (40) having a manifold inlet (46) and a plurality of manifold outlets (42; see Figure 1), the manifold inlet having a connector that is configured to be in fluid communication with a feedline to receive a fluid therefrom, each manifold outlet of the plurality of manifold outlets in fluid communication with the manifold inlet; and
a set of hubs (56; Fig. 6) corresponding to the number of manifold outlets of the manifold, each hub of the set of hubs including a hub inlet (54) and a plurality of hub outlets (60), to a respective manifold outlet, each hub outlet configured to be in fluid communication with a respective container (66) to fill the respective container with fluid from the respective hub. The Phallen reference doesn’t disclose aseptic connectors at the inlets and outlets of the manifold and hubs. The Kjar reference discloses another manifold fluid distribution system (Figure 1) having a manifold system (14) comprising aseptic connectors (130) to enable sterile fluid connections between fluid lines when needed (see col. 6, lines 24 – 53). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify the Phallen device to have aseptic connectors as, for example, taught by the Kjar reference in order to enable sterile fluid connections between fluid lines when needed.
Regarding claim 2, the Phallen reference further discloses a supply line (unlabeled; located between the manifold 40 and supply container 20) aseptically connected to the manifold inlet to provide fluid to the manifold.
Regarding claim 3, the Phallen reference further discloses a pump (24), the supply line received in the pump such that the pump controls a flow of fluid through the supply line. See para. [0065].
Regarding claim 4, the Phallen reference further discloses a supply container (20) in fluid communication with the supply line, the supply container (24) configured to provide fluid to the manifold for distribution to each hub of the set of hubs.
Regarding claim 5, the Phallen reference further discloses wherein each hub (56) of the set of hubs including a plurality of containers (66), each container of the plurality of containers in fluid communication with a respective hub outlet of the respective hub, each hub including a number of containers equal to a number of hub outlets of the respective hub. See Figure [0085]; Figure 6.
Regarding claim 6, wherein the manifold includes a trunk and a plurality of branches in fluid communication with the trunk, each branch extending from the
trunk to a respective one of the manifold outlets. See Annotated Figure 6.
Regarding claim 7, wherein each branch terminates at a respective one of the manifold outlets (inherent).
Regarding claim 10, the Phallen reference further discloses in Figure 5 that the hubs (56) can be configured to sequentially (see para. [0131]) receive fluid from the manifold such that each hub sequentially distributes fluid therethrough, and further discloses manifold outlets includes five manifold outlets and the set of hubs includes five hubs. See Figure 5.
Regarding claim 11, the Phallen reference further discloses wherein each hub (56) of the set of hubs includes a plurality of containers (66) with each container in fluid communication with a respective hub outlet, each hub configured to simultaneously distribute a substantially equal amount of fluid to each container in fluid communication therewith. See para. [0042].
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Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Phallen (2015/0114515) in view Bullen (8016003).
Regarding claim 8, the Phallen reference discloses the invention (discussed supra), but doesn’t disclose wherein each branch is configured to be sealed when the branch is crimped to disconnect the respective hub. The Bullen reference discloses another manifold dispenser (Fig. 2) which further includes mechanical crimp separation when connective structures are separated (see col. 7, lines 35 – 44). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify the Phallen device to include crimping as, for example, taught by the Bullen reference, since crimping is well known in the art, conventional and would be obvious to try when necessary without unexpected results.
Claim(s) 12 - 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Phallen (2015/0114515) in view Mendels (7563243; cited prior art).
Regarding claim 12, the Phallen reference discloses the invention (discussed supra; see claim 1 rejection), but doesn’t disclose a plurality of closure systems, each closure system of the plurality of closure systems associated with each first manifold outlet and configured to independently close the respective first manifold outlet. The Mendels reference discloses another manifold hub dispensing system (Fig. 9) having valves (1015, 1025, 1035, 1045, 1055) to control fluid flow. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify the Phallen device to have a plurality of closure systems (i.e., valves) at each manifold outlet as, for example, taught by the Mendels reference in order to further control fluid flow within the system.
Regarding claim 13, see rejection of claim 2.
Regarding claim 14, see rejection of claim 3.
Regarding claim 15, further comprising a supply vessel (20) in fluid communication with the supply line, the supply line configured to provide fluid to the first
manifold (40) for distribution to each second manifold (58) of the set of second manifolds. See Annotated Figure 6.
Regarding claim 16, wherein each second manifold of the set of second manifolds (58) including a plurality of containers (66), each container of the plurality of containers in fluid communication with a respective second manifold outlet of the respective second manifold, each second manifold including a number of containers equal to a number of second manifold outlets of the respective second manifold. See Figure 6.
Allowable Subject Matter
Claims 17 – 20 are allowed.
Regarding claim 17, the following is a statement of reasons for the indication of allowable subject matter: None of the prior art, alone or in combination, teach a method of aseptically distributing fluid to a plurality of vessels, the method comprising:
disconnecting a first hub from the first manifold after filling the plurality of first containers, the first manifold outlet being sealed when the first hub is disconnected;
connecting a second hub to a second manifold outlet of the first manifold with a second
tube; discharging a second quantity of the fluid from the second manifold outlet to the second hub via the second tube, the first manifold inlet, the second manifold outlet, and the second tube forming a second aseptic fluid pathway; and
filling a plurality of second containers, each second container in fluid communication with a respective hub outlet of the second hub, each hub outlet of the second hub in fluid communication with an inlet of the second hub, as defined in claim 17 along with all other claim limitations.
Claims 18-20 are dependent upon claim 17.
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/TIMOTHY L MAUST/Primary Examiner, Art Unit 3753