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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-32 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Veraitch (WO 2021/123760) .
The applied reference has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Veraitch discloses a connector (Fig. 1, 100), for introducing or extracting a material to or from at least one receptacle (Abstract), comprising:
- a housing (Fig. 1, 102) extending between a distal end and a proximal end (Pg. 43, lines 10-15), the housing comprising, at least at one end, a pierceable seal (Fig. 2, 110);
- a hollow needle (Fig. 2, 112) mounted, at least partially, within the housing between the distal end and the proximal end of the housing (Pg. 44, lines 1-2), a first end of the hollow needle being connected or connectable to a first receptacle (Pg. 44, lines 1-8), and a second end of the hollow needle facing the pierceable seal at an end of the housing (Pg. 43, lines 27-29); and
- an actuating mechanism (Fig. 3, 132) acting on the housing (102) or the hollow needle (112) to enable the hollow needle to pierce the pierceable seal, thereby forming a communication through the pierceable seal, such that material is able to transfer through the connector (Pg. 45, lines 6-24),
wherein the pierceable seal comprises a distal end (Fig. 2, 108) and a proximal end (Fig. 2, 110), the second end of the hollow needle facing the distal end (Fig. 2, where one end of the needle faces 108) of the pierceable seal, and the proximal end comprising an engagement element engaging a portion of the hollow needle (where 110 has a slot that engages a part of the hollow needle as shown in figure 2, Pg. 43, lines 19-33).
Regarding claim 2, Veraitch discloses a connector according to claim 1, wherein the engagement element frictionally engages the hollow needle (112)(Fig. 2, 108 112, where the seal has a slot which is frictionally engaged with at least part of the needle).
Regarding claim 3, Veraitch discloses a connector according to claim 2, wherein the engagement element circumferentially frictionally engages the hollow needle (112) to form an aseptic seal (Fig. 2, where the seal is circumferentially surrounding 112 and forms an aseptic seal).
Regarding claim 4, Veraitch discloses a connector according to claim 3, wherein the pierceable seal comprises a tubular body extending between the distal end and the proximal end, the tubular body aseptically enclosing the second end of the hollow needle (Fig. 2, where the seal 110 extends in a tubular fashion and encloses the second end of the needle of the needle in an aseptic manner, Pg. 43, lines 19-33).
Regarding claim 5, Veraitch discloses a connector according to claim 1, wherein the engagement element comprises one or more ribs extending inwardly from the proximal end of the pierceable seal towards, and into engagement with, the hollow needle (Fig. 2, where the element 110 or 108 has walls around the slot which are interior to the rest of the seal and engage the needle).
Regarding claim 6, Veraitch discloses a connector according to claim 1, wherein the first end of the hollow needle is fluidly connected or fluidly connectable to a first receptacle (Pg. 47, lines 13-23), and wherein the actuating mechanism enables the hollow needle to pierce the pierceable seal to fluidly connect the second end of the hollow needle to a second receptacle (Pg. 47, lines 13-23).
Regarding claim 7, Veraitch discloses a connector according to claim 1, wherein the actuating mechanism comprises a collapsible housing (Pg. 6, lines 32-33) (Fig. 2, where the housing can be collapsed on a longitudinal axis) wherein at least part of the housing is collapsible between the proximal end and the distal end to enable the hollow needle to pierce the pierceable seal, thereby forming a communication through the pierceable seal, such that material is able to transfer through the connector (Pg. 8, lines 5-16).
Regarding claim 8, Veraitch discloses a connector according to claim 7, wherein the collapsible housing comprises an upper housing portion (Fig. 2, 102a) and a lower housing portion (Fig. 2, 102b), the upper housing portion being axially moveable along a central longitudinal axis with respect to the lower housing portion so as to collapse with respect thereto (Pg. 43, lines 4-9).
Regarding claim 9, Veraitch discloses a connector according to claim 8, wherein the upper housing portion comprises at least one actuatable lug (Fig. 36, 902) configured to move the upper housing portion along the central longitudinal axis (Pg. 13, line 31-pg. 14, line 9).
Regarding claim 10, Veraitch discloses a connector according to claim 8, further comprising a collar (Fig. 37, 118) operably coupled to the hollow needle, the collar comprising at least one actuatable lug configured to move the collar along the central longitudinal axis (Pg. 13, line 31-pg. 14, line 9).
Regarding claim 11, Veraitch discloses a connector according to claim 9, further comprising: further comprising a collar (118) operably coupled to the hollow needle (112), the collar comprising at least one actuatable lug (902) configured to move the collar along the central longitudinal axis (Pg. 13, line 31-pg. 14, line 9); and an outer sleeve (Fig. 36, 134) including a side wall having a first slot (Fig. 36, 1002), receiving a first actuatable lug of the upper housing portion and a first actuatable lug of the collar, and a second slot, diametrically opposed to the first slot, receiving a second actuatable lug of the upper housing portion and a second actuatable lug of the collar (Pg. 58, lines 16-26).
Regarding claim 12, Veraitch discloses a connector according to claim 1, wherein the actuating mechanism comprises an outer sleeve (134) configured such that at least a partial rotation of the outer sleeve causes axial translation of the hollow needle to pierce the pierceable seal thereby forming a communication through the pierceable seal, such that material is able to transfer through the connector (Pg. 45, lines 6-24).
Regarding claim 13, Veraitch discloses a connector according to claim 12, wherein the outer sleeve (134) is configured such that the outer sleeve causes a releasable locking engagement between a proximal end of the outer sleeve of the connector and a portion of a second receptacle (Pg. 45, lines 17-24).
Regarding claim 14, Veraitch discloses a connector according to claim 1, wherein the hollow needle is a double ended needle (Pg. 15, line 8).
Regarding claim 15, Veraitch discloses a connector according to claim 14, wherein both the proximal end and the distal end of the housing comprise a pierceable seal (Fig. 2, where there are two different seals to be pierced, Pg. 15, lines 11-12).
Regarding claim 16, Veraitch discloses a connector according to claim 15, wherein the double ended hollow needle (112) is mounted within the housing (102), and wherein each end of the double ended hollow needle, face a pierceable seal at both the proximal end and the distal end of the housing (Fig. 2, where each end of the needle 112 faces either 108 or 110).
Regarding claim 17, Veraitch discloses a connector according to claim 16, wherein the first end of the double ended hollow needle comprises a pencil-point closed end and at least one port adjacent the pencil-point closed end, and wherein the second end of the double ended hollow needle comprises a bevelled open end (Pg. 15, lines 19-27).
Regarding claim 18, Veraitch discloses a connector according to claim 15, wherein the actuating mechanism is configured to enable the double ended hollow needle to pierce the pierceable seal at both the proximal end and the distal end of the housing (Pg. 16, lines 1-3).
Regarding claim 19, Veraitch discloses a connector according to claim 18, wherein the double ended hollow needle is biasedly mounted within the housing; and further wherein the actuating mechanism comprises an outer sleeve configured such that at least a partial rotation of the outer sleeve causes axial translation of the double ended hollow needle to pierce at least one pierceable seal, thereby forming a communication through the at least one pierceable seal (Pg. 16, lines 16-20).
Regarding claim 20, Veraitch discloses a connector according to any one of claim 14, wherein the double ended hollow needle is biasedly mounted in a direction towards the proximal end of the housing by a first biasing mechanism (Pg. 20, lines 23-25).
Regarding claim 21, Veraitch discloses a connector according to claim 14, wherein the double ended hollow needle is biasedly mounted in a direction towards the distal end of the housing by a second biasing mechanism (Pg. 20, lines 23-25).
Regarding claim 22, Veraitch discloses a connector according to claim 20, wherein the double ended hollow needle is biasedly mounted in a direction towards the distal end of the housing by a second biasing mechanism, and wherein the first biasing mechanism provides a first biasing force, and the second biasing mechanism provides a second biasing force, the first biasing force and the second biasing force being approximately equal (Pg. 20, lines 26-28).
Regarding claim 23, Veraitch discloses a connector according to claim 20, wherein the double ended hollow needle is biasedly mounted in a direction towards the distal end of the housing by a second biasing mechanism, and wherein the first biasing mechanism provides a first biasing force, and the second biasing mechanism provides a second biasing force, the first biasing force being greater than the second biasing force (Pg. 21, lines 1-3).
Regarding claim 24, Veraitch discloses a connector according to claim 1, wherein the connector further comprises an aseptic seal system (730) including an aseptic membrane (734) and a clip portion (732), the aseptic membrane being disposed over the pierceable seal at the or each end of the housing of the connector and being operably coupled to the clip portion (Pg. 23, lines 10-13).
Regarding claim 25, Veraitch discloses a connector according to claim 24, wherein the clip portion is slidably operably connected to the connector such that the clip portion is slidable between a first configuration, in which the aseptic membrane is disposed over the or each pierceable seal, and a second configuration, in which the aseptic membrane is removed from the or each pierceable seal (Pg. 23, lines 17-21).
Regarding claim 26, Veraitch discloses a connector according to claim 1, wherein a second receptacle (300) is connected, or connectable, to the housing of the connector (Pg. 28, lines 1-14).
Regarding claim 27, Veraitch discloses a connector according to claim 1, wherein the communication through the pierceable seal comprises a communication between a connected, or connectable, first receptacle and a connected, or connectable, second receptacle, such that material is able to transfer through the connector between the first receptacle and the second receptacle (Pg. 28, lines 15-25).
Regarding claim 28, Veraitch discloses a system (Fig. 1) comprising:
a connector (Fig. 1, Fig. 7, 100), for introducing or extracting a material to or from at least one receptacle, comprising:
- a housing (Fig. 1, 102) extending between a distal end and a proximal end (Pg. 43, lines 10-15), the housing comprising, at least at one end, a pierceable seal (Fig. 2, 110);
- a hollow needle (Fig. 2, 112) mounted, at least partially, within the housing between the distal end and the proximal end of the housing (Pg. 44, lines 1-2), a first end of the hollow needle being connected or connectable to a first receptacle (Pg. 44, lines 1-8), and a second end of the hollow needle facing the pierceable seal at an end of the housing (Pg. 43, lines 27-29); and
-an actuating mechanism acting (Fig. 3, 132) on the housing or the hollow needle to enable the hollow needle to pierce the pierceable seal, thereby forming a communication through the pierceable seal, such that material is able to transfer through the connector (Pg. 45, lines 6-24), wherein the pierceable seal comprises a distal end (108) and a proximal end (110), the second end of the hollow needle facing the distal end of the pierceable seal (Fig. 2, where one end of the needle faces 108), and the proximal end comprising an engagement element engaging a portion of the hollow needle (where 110 has a slot that engages a part of the hollow needle as shown in figure 2, Pg. 43, lines 19-33);
- a first receptacle (Fig. 7, 200) detachably coupled to one end of the connector and wherein the first receptacle is connected to the first end of the hollow needle (Fig. 7, where the needle 112 runs through the housing and connects to 200) ; and
- a second receptacle (Fig. 7, 300) detachably coupled to one end of the connector and wherein the second receptacle is connected to the second end of the hollow needle (Fig. 7, where the needle 112 runs through the housing and connects to 300).
Regarding claim 29, Veraitch discloses a method of connecting two receptacles, comprising the steps of:
- providing a connector (Fig. 1, Fig. 7, 100), the connector comprising:
- a housing (Fig. 1, 102) extending between a distal end and a proximal end (Pg. 43, lines 10-15), the housing comprising, at least at one end, a pierceable seal (Fig. 2, 110);
- a hollow needle (Fig. 2, 112) mounted, at least partially, within the housing between the distal end and the proximal end of the housing (Pg. 44, lines 1-2), a first end of the hollow needle being connected or connectable to a first receptacle (Pg. 44, lines 1-8), and a second end of the hollow needle facing the pierceable seal at an end of the housing (Pg. 43, lines 27-29); and
- an actuating mechanism (Fig. 3, 132) acting on the housing (102 or the hollow needle (112) to enable the hollow needle to pierce the pierceable seal, thereby forming a communication through the pierceable seal, such that material is able to transfer through the connector (Pg. 45, lines 6-24),
wherein the pierceable seal comprises a distal end (Fig. 2, 108) and a proximal end (Fig. 2, 110), the second end of the hollow needle facing the distal end (Fig. 2, where one end of the needle faces 108) of the pierceable seal, and the proximal end comprising an engagement element engaging a portion of the hollow needle (where 110 has a slot that engages a part of the hollow needle as shown in figure 2, Pg. 43, lines 19-33).
- connecting the distal end of the housing of the connector to a first receptacle, such that the first receptacle is connected to the first end of the hollow needle (Pg. 45, lines 25-27));
- detachably connecting the proximal end of the housing of the connector to a second receptacle comprising a pierceable seal, such that the pierceable seal of the connector is coaxially aligned with the pierceable seal of the second receptacle (Pg. 46, lines 12-20);
- actuating the hollow needle to pierce the pierceable seal of the housing of the connector and through the pierceable seal of the second receptacle, thereby connecting the first receptacle and the second receptacle (Pg. 47, lines 13-23).
Regarding claim 30, Veraitch discloses a sterile connector (Fig. 1, 100), for introducing or extracting a material to or from at least one receptacle, comprising:
- a housing (Fig. 1, 102) extending between a distal end a proximal end (Pg. 43, lines 10-15), the housing comprising a first pierceable seal at the distal end (Fig. 2, 108) and a second pierceable seal at the proximal end (Fig. 2, 110);
- a hollow needle (Fig. 2, 112) mounted within the housing between the distal end and the proximal end (Pg. 44, lines1-2), a first end of the hollow needle facing the first pierceable seal (108) and being connectable to a first receptacle (Pg. 45, lines 25-27), and a second end of the hollow needle facing the second pierceable seal (110) and being connectable to a second receptacle (Pg. 46, lines 12-20); and
- an actuating mechanism (Fig. 3, 132) acting on the housing (102) or the hollow needle (112) to enable the hollow needle to pierce the first pierceable seal and the second pierceable seal, thereby forming a sterile communication through the first and second pierceable seals, such that material is able to transfer through the sterile connector (Pg. 45, lines 6-24),
wherein each of the first and second pierceable seals comprise a distal end and a proximal end, the second end of the hollow needle facing the distal end of each of the first and second pierceable seals (Fig. 2, where the distal ends of the seals 108 and 110 are facing the needle 112 within the housing 102), and the proximal end comprising an engagement element engaging a portion of the hollow needle (Fig. 2, where each of 108 and 110 have a slot that engages with the needle 112).
Regarding claim 31, Veraitch discloses a sterile package or a sterile container comprising the connector according to according to claim 30 (Pg. 63, lines 1-8).
Regarding claim 32, Veraitch discloses a pierceable seal for a connector, comprising a tubular body extending between a distal end, having a closed end, and a proximal end (Fig. 2, where the seal 110 extends in a tubular fashion and encloses the second end of the needle of the needle in an aseptic manner, Pg. 43, lines 19-33), comprising an engagement element extending inwardly towards a central longitudinal axis of the pierceable seal (Fig. 2, where the element 110 or 108 has walls around the slot which are interior to the rest of the seal and engage the needle).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783