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) 1-3, 7, 8, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iino et al. (US 2023/0346643).
Regarding claim 1, Iino et al. (henceforth Iino) discloses an infusion system comprising: an infusion adapter (30, Figure 1; ¶ [0034]) comprising a spike (spike adapter 25; ¶ [0033]) configured to pierce a seal of an infusion container (¶ [0033], the spike pierces infusion bag 20), a grip portion extending radially outward relative to the spike (comprising manipulation portions 72; Figure 3; ¶¶ [0066]-[0068] disclose the manipulation portions for gripping by a user), and a connection interface (opening of housing 30 such as 30a; Figure 3; ¶ [0037]) comprising a membrane (needle seal 110; ¶ [0072]), the infusion adapter defining a passageway extending from a first end of the infusion adapter to the second end of the infusion adapter (flow path member 80 provides for flow path L2; ¶ [0069]), the membrane sealing the passageway at the second end of the infusion adapter (seal 110 can be seen in Figure 4 to be at an end of the connector which can be considered the second end); and a connection adapter (connection member 40 and structure for connecting to spike 80; Figure 2) comprising a spike port (area labeled “L1” in Figure 2 may be considered a spike port as it allows for fluid to flow from piercing flow path L2 within spike 80, through to any connected device attached to port 40); and a connector body comprising a luer connector (inner surface of portion 40a for receiving male luer 2b; ¶ [0048]; Figure 2).
Regarding claim 2, Iino further discloses wherein the spike port (e.g., cylinder tip 2 of syringe 1) is connected to the connector body via an interference fit (luer taper fit between 2b and 41; Figure 2).
Regarding claim 3, Iino further discloses wherein the luer connector (male luer 2b) comprises a male luer lock connector (¶ [0032]; Figure 2; male luer 2b of connector 2 receives female screw 2a forming a male luer lock connection).
Regarding claim 7, Iino further discloses wherein the grip portion has first and second planar surface (engagement members 70 have at least two planar surfaces each, formed as portions of 70 which are grippable by a user; Figure 3; ¶¶ [0065]-[0066]).
Regarding claim 8, Iino further discloses wherein the grip portion comprises first and second openings (the manipulation portions extend from holes 35; ¶ [0040]; Figure 3).
Regarding claim 10, Iino further discloses wherein the connection interface comprises a plurality of cantilever arms each having a protrusion (the connection interface includes two holes 35, each of which have an engagement member 70, having a cantilever arm shape, and a manipulation member 72 protruding from each engagement member; ¶ [0066]; see also the structure of the arms in Figure 5).
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) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iino in view of Berg et al. (US 2024/0033182).
Regarding claim 4, Iino discloses the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose wherein the grip portion is annular.
Berg et al. (henceforth Berg) teaches an annular coupling device comprising a plurality of snap hooks 111 that act to grip a vial (¶ [0073]; the actual grip portion is the surface of the hooks engaged with the vial head and neck as depicted in Figure 5) and which are annular as claimed (e.g., Figures 5-6).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the grip means of Iino to comprise the annular coupling means of Berg to prevent relative movement of the connector from the fluid source after coupling as taught by Berg. Berg therefore presents a known alternative to the cantilevered grip portion of Iino which functions in a similar manner to achieve the same goal of retaining the connector on another element.
Regarding claim 5, Berg further teaches wherein the grip portion is bowl shaped (e.g., Figures 7-8, the grip portion of the connector is bowl-shaped as claimed as the fingers curve in a gradual annular manner).
Regarding claim 6, Berg further teaches wherein the maximum diameter of the grip portion is 17 mm (e.g., Berg teaches in ¶ [0016] that the vial neck size to be engaged is 13 mm; see Figure 5, wherein the grip portion 111 closely engages vial neck portion 232; the grip portion is considered to be the surfaces of 111 which engage the vial head 231 on neck 232 and which would be only slightly greater than the 13 mm of the neck depending on tolerances).
Claim(s) 9, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iino in view of Sanders (US 10,744,315).
Regarding claim 9, Iino discloses the claimed invention substantially as set forth above for claim 1, and further discloses a syringe coupling to the adapter of the connector (Figure 2). Iino fails to explicitly disclose wherein the syringe adapter is configured to receive the connection interface of the infusion adapter and configured to be connected to the connection adapter via the luer connection.
Sanders teaches a connector for a system for a closed transfer of fluids (Sanders is explicitly set forth in ¶ [0033] of the instant application disclosure as being analogous to the claimed syringe connector) comprising a syringe adapter (12) configured to receive a connection interface of an infusion adapter (102 would be analogous to the infusion adapter of Iino) and configured to be connected to a connection adapter via a connection means such as a luer adapter(e.g., Figure 6, the syringe adapter 12 receives the first end 104 of body 102 which comprises membrane 94 in a pierceable fashion to fluidly connect the syringe adapter to the infusion adapter; see also Col. 8, lines 8-25; Col. 5, lines 21-30 disclose syringe connection 24 as a luer connector as claimed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the connector means of Iino to comprise an additional syringe adapter, such as that taught by Sanders, for the purpose of providing a secure means of fluidly connecting a syringe to the flow path to allow for the transfer of fluids between components of the flow path as taught by Sanders (Col. 5, lines 4-20).
Regarding claim 11, Iino discloses a method of using an infusion system, the method comprising: providing a plurality of infusion containers (see ¶ [0124] which disclose additional containers connected at branch 146; Iino discloses IV bags and vials but all bags would have the same piercing location which acts as a seal until punctured), each of the plurality of infusion containers including a seal (the disclosed IV bag is pierced by spike portion 125 and the part of the bag which is pierced is considered a seal as claimed); providing an infusion adapter (e.g., spike 125 portion of connector 10), comprising a spike (125) configured to pierce a seal of the plurality of infusion containers (¶ [0107]), the infusion adapter also including a grip portion (e.g., 70) extending radially outward relative to the spike (Figure 3), and a connection interface comprising a membrane (110; Figure 4), the infusion adapter defining a passageway extending from a first end of the infusion adapter to the second end of the infusion adapter (through 80), the membrane scaling the passageway at the second end of the infusion adapter (Figure 4); and a connection adapter comprising a spike port (40; the volume within 40 receives fluid from element 80 which is a spike and it might therefore be considered a “spike port” as claimed) and a connector body comprising a luer connector (40a; ¶ [0048]); inserting the spike of the infusion adapter within the seal of a first infusion container of the plurality of infusion containers (¶ [0107]). Iino fails to explicitly disclose the use of the syringe adapter which is connected to the infusion adapter via the connection interface and that the connection adapter to the syringe adapter is via the luer connector.
Sanders teaches a connector for a system for a closed transfer of fluids (Sanders is explicitly set forth in ¶ [0033] of the instant application disclosure as being analogous to the claimed syringe connector) comprising a syringe adapter (12) configured to receive a connection interface of an infusion adapter (102 would be analogous to the infusion adapter of Iino) and configured to be connected to a connection adapter via a connection means such as a luer adapter(e.g., Figure 6, the syringe adapter 12 receives the first end 104 of body 102 which comprises membrane 94 in a pierceable fashion to fluidly connect the syringe adapter to the infusion adapter; see also Col. 8, lines 8-25; Col. 5, lines 21-30 disclose syringe connection 24 as a luer connector as claimed). In the cited combination, the patient connector (96) of Sanders comprises a spike port for receiving the spike of syringe adapter (12) into a fluid channel through seal (94). The connection adapter of Sanders is disclosed to have a connection member (154) for engagement with the syringe adapter (see e.g., Figure 27 which shows an engaged embodiment), and Sanders further clarifies that this engagement can be any known engagement means (Col. 9, line 62-Col. 10, line 31).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the connector means of Iino to comprise an additional syringe adapter, such as that taught by Sanders, for the purpose of providing a secure means of fluidly connecting a syringe to the flow path to allow for the transfer of fluids between components of the flow path as taught by Sanders (Col. 5, lines 4-20). In this manner, Sanders provides a means of securely attaching a syringe adapter to an IV bag fluid connector via a connection interface for transferring fluid through the system as claimed. Furthermore, in the cited combination, the infusion adapter of Iino would be attached to the bag and would allow for selective coupling of the syringe adapter to the infusion adapter via engagement of the syringe adapter with the connection interface at the distal end of the infusion adapter of Iino. Furthermore, it would have been obvious to one of ordinary skill to utilize a luer lock connection between the syringe adapter and the patient connector of Sanders rather than a generic connection member since both Iino and Sanders utilize luer lock fittings for fluid connections in their devices. Because Sanders explicitly states that the connection of the patient connector to the syringe adapter can be of any known connection type, it would have been obvious to use a luer connection to maintain the fluid-tightness of the system during the transfer of fluids as claimed.
Regarding claim 12, Iino/Sanders further teach placing the spike port of the connection adapter in fluid communication with a patient infusion line (in the cited combination, once the infusion adapter is located in the bag via the spike, the spike 80 of Iino will be in fluid communication with a patient infusion line via forming a downstream connected portion thereof).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iino in view of Sanders (US 10,744,315), and further in view of Yu (US 2007/0156089).
Regarding claim 13, Iino/Sanders teach the claimed invention substantially as set forth above for claim 12, but fail to explicitly disclose the use of an infusion pump.
Yu teaches an infusion system which utilizes a plurality of IV bags (5; Figure 1) and comprises the step of activating an infusion pump (18; Figure 1; ¶¶ [0031] and [0036]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system and method of Iino/Sanders to comprise the use of an infusion pump, such as that disclosed by Yu, to allow for electronic control of the fluid delivered during an infusion procedure under a desired pressure as taught by Yu.
Regarding claim 14, Iino discloses the use of a flexible IV bag (20), and discloses other attachable fluid sources such as vials (see ¶ [0112]), but does not explicitly disclose the use of multiple IV bags.
Yu teaches (Figure 1) that multiple IV bags can be used simultaneously or independently during a procedure (¶ [0039].
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Iino/Sanders to comprise multiple fluid sources, such as those taught by Yu, for the purpose of providing multiple IV therapies to the patient during an infusion procedure as taught by Yu (¶ [0021]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iino in view of Sanders in view of Yu, and further in view of Alexander et al. (US 4,209,013).
Regarding claim 15, Iino/Sanders/Yu further teach the use of a plurality of infusion containers; and connecting the syringe adapter to the second infusion adapter via the connection interface. This claim is essentially performing the method of claim 11 a second time on a second bag. In the cited combination, the device of Iino/Sanders/Yu provides for multiple IV bags to be connected to syringe adapters via a spike interface (e.g., that of Iino/Sanders and the spiked connections 6 of Yu). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of use of the device of Iino/Sanders/Yu to connect a syringe adapter to any IV bag that one wished to fluidly connect a syringe to. The combined device provides for using a plurality of syringe adapters if each line of the independent IV bags are required to connect the adapter to any of the bags during a procedure for fluid transfer. Since the IV bags and pumps are independent from each other, the adapter can readily be swapped between bags in a sequential infusion or a plurality of syringe adapters could be connected during a simultaneous infusion of multiple medicaments. Iino/Sanders/Yu fail to explicitly disclose the step of disconnecting the first container before attaching a second adapter to a different IV bag.
Alexander et al. (henceforth Alexander) teaches a medical infusion system wherein, after a first solution bag is drained, the step of disconnecting a fluid connector from the first bag, and inserting it into a second bag of fresh solution.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Iino/Sanders/Yu to comprise the step of disconnecting a first bag of one of the plurality of bags and inserting a second connector into a second bag before connecting to the syringe adapter. Alexander teaches that it is known to disconnect fluid connectors after a bag is drained before attaching to a second bag. Therefore, it is known from the cited combination, to perform the steps of disconnecting the first container (known from Alexander), attaching a spike of a second infusion adapter to a second bag (Yu teaches multiple bags, each with their own spike connector 6 which would be replaced by the infusion adapter of Iino/Sanders), and connecting the syringe adapter to the second bag via the connection interface (in the cited combination, each bag of Yu, would comprise an infusion adapter to be selectively coupled to the syringe adapter for performing the fluid connection and transfer taught by Iino/Sanders).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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