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 Claims
Applicant amended claims 13 and 16, and added claim 22. Claims 13-22 are currently pending.
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 13-22 are rejected under 35 U.S.C. 103 as being unpatentable over Guala (US 2007/0043334 A1) in view of Miller (US 6,651,956 B2), in further view of Zinger et al. (US 2009/0177177 A1), and in further view of Py (US 2011/0240158 A1).
Regarding claim 13, Guala discloses a safety assembly for reconstituting, taking or infusing a pharmacological fluid (Figs. 1-3), the safety assembly comprising: a safety device (Figs. 1-3, feat. 1; ¶0034) having a first coupler (Figs. 2-3, feat. 4; ¶0035) adapted to be coupled to a coupler of a needleless syringe so as to fix said safety device to a needless syringe (7 and 8; ¶0035: Outlet fitting 4 is a female luer lock fitting, which is a standard medical fitting for coupling to complementary male fittings which may be found on the tips of syringes; Outlet fitting 4 includes a thread 8, which would fix the safety device to an attached syringe which a matching thread), said safety device having an axial duct (2) in which a second membrane is disposed (15; ¶0037-0040), the second membrane having a through hole (23) and being in a non-compressed closed position (Fig. 2; ¶0040), the through hole of the second membrane being closed in the non-compressed closed position so as to obstruct a passage of liquid in the axial duct of said safety device (¶0040 and 0043), the through hole of the second membrane being openable to a compressed open position which does not obstruct the passage of liquid in the axial duct of said safety device (Fig. 3; ¶0044), the second membrane having a channel in communication with the through hole of the second membrane (Annotated figure 1, feat. A: the diaphragm 22 of the elastic body 15 is concave and has a channel A in communication with the through hole 23 when it is open); a second compression element having a cannula (6; ¶0035-0041) slidingly mounted into the axial duct of said safety device (¶0037: tubular element 6 is axially mobile with respect to the body 2) so as to compress the second membrane into the compressed open position (Fig. 3; ¶0044), the cannula having an ending portion (9) and a tip (6a); and wherein said safety device has a second coupler (3 and 5) adapted to be coupled to a coupler of a user device so as to fix said safety device to a user device (¶0035: inlet fitting 3 is a male luer lock fitting, which is a standard medical fitting for coupling to complementary female fittings which are found on a variety of medical devices; Inlet fitting 3 includes an internally threaded portion 5, which would fix the safety device to an attached medical device), the ending portion of the cannula being in interference relationship within an axial duct of a user device and the tip of the cannula is in position to push the second membrane of said safety device to the compressed open position when a coupler of a user device is coupled with the second coupler of said safety device (Figs. 2-3; ¶0044: When a complementary female luer-lock fitting is screwed to the inlet fitting 3, the interaction between the conical surface of ending portion 9 and the corresponding conical surface of the female luer-lock fitting causes axial translation of the inner tubular element 6 from the retracted position of fig. 2 to the advanced position of fig. 3, such that the open end 6a of the cannula deformed the elastic body 15 and opens its through hole 23).
Guala does not disclose that the safety device has a first membrane disposed in the axial duct and comprising a through hole and being in a non-compressed closed position so as to obstruct a passage of liquid in the axial duct and being openable to a compressed open position which does not obstruct the passage of liquid in the axial duct and further comprising a channel in communication with the through hole of the first membrane, and is further silent with respect to the assembly comprising a needless syringe having an axial duct in communication with an opening, said needleless syringe having a coupler corresponding to the opening, a first compression element cooperative with the coupler of said needleless syringe so as to compress the first membrane to the compressed open position when the coupler of said needleless syringe is coupled to the first coupler of said safety device, a user device having an axial duct in communication with an opening thereof, said user device having a coupler corresponding with the opening of said user device, said user device having a needle adapted to inject pharmacological fluid to a user or adapter to connect to a receptacle for administration of pharmacological fluid. Guala is further silent with respect to the first membrane and the second membrane being identical and opposite and in mutual contact and to the channels of the first membrane and the second membrane being coaxial and defining at
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[AltContent: textbox (Annotated fig. 1: Adapted from figure 2 of Guala. A is the channel of the second membrane 15 (see the rejection of claim 14 above). B is the first portion of the lid comprising first coupler 4 and C is a second portion of the lid comprising first coupler 4 (see the rejection of claim 18 below). D is a shoulder of body 2 (see the rejection of claim 19 below).)]least a portion of a flow path through the safety device.
Miller teaches a medical fluid transfer valve (Figs. 1-4, feat. 10; Col. 4, lines 20-55) with a valve body (12) comprising a first coupler (20) comprising a threaded female luer lock fitting (Figs. 3-4, feat. 76) for engaging the threads of a corresponding threaded male luer lock fitting (78) on a needleless syringe or other instrument (22; Col. 4, lines 20-29; Col. 7, line 27 – Col. 8, line 20). The valve further includes a second coupler (24) comprising a threaded male luer lock fitting (28) for providing fluid communication with a fluid line or other device (Col. 4, lines 20-55). The valve body (12) further comprises an axial bore (14) housing a valve stem or membrane (32; Col. 4, line 56 – Col. 5, line 23) further comprising a through hole (52) and a channel (50). When a needleless syringe (22) is coupled to the first coupler (12), the tip of the syringe (56) acts as a compression element to compress and deform the membrane (32) to put the channel (50) in fluid communication with the through hole (52) and allow fluid flow through the valve (Col. 7, line 27 – Col. 8, line 20). As the syringe tip (56) is withdrawn, the natural resilience of the membrane (32) advantageously wipes the tip free of fluid, which advantageously reduces the waste of expensive solutions and minimizes unintended human exposure to the fluid (Col. 8, lines 28-40). As discussed above, the safety device of Guala only has a membrane (Guala, figs. 2-3, feat. 15) on the second coupler side of the device (Guala, figs. 2-3, feat. 3) which is opened by attaching a device to the second coupler, and modifying the device of Guala to include the syringe actuated membrane of Miller on the first coupler side of the device (Guala, figs. 2-3, feat. 4) would advantageously minimize human exposure to fluid transferred through the device by wiping attached syringes free of excess fluid as taught by Miller (Miller: Col. 8, lines 28-40). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the assembly disclosed by Guala so that the safety device has a first membrane disposed in the axial duct and comprising a through hole and being in a non-compressed closed position so as to obstruct a passage of liquid in the axial duct and being openable to a compressed open position which does not obstruct the passage of liquid in the axial duct and further comprising a channel in communication with the through hole of the first membrane and so that the assembly comprises a needless syringe having an axial duct in communication with an opening, said needleless syringe having a coupler corresponding to the opening, a first compression element cooperative with the coupler of said needleless syringe so as to compress the first membrane to the compressed open position when the coupler of said needleless syringe is coupled to the first coupler of said safety device in order to minimize unintended human exposure to fluid transferred through the safety device as taught by Miller.
As discussed above, Guala discloses that the cannula of the safety device comprises an ending portion (Figs. 2-3, feat. 9; ¶0044) which interacts with a complementary female luer-lock fitting of a user device to cause axial movement of the cannula. However, Guala in view of Miller are silent with respect to the particulars of the claimed user device.
Zinger teaches a liquid drug transfer device, or in other words a user device, (Figs. 1-2, feat. 10) comprising a female luer connector (32) and a needle (38) which allows a receptacle for administration of a pharmacological fluid (14) such as a vial (11) to be put in fluid communication with the female luer connector (¶0016-0019). Zinger teaches that the liquid drug transfer device, or user device, includes flex members which allow for correct alignment with the vial, which enables successful fluid transfer of a liquid drug (¶0004-0005). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the assembly disclosed by Guala in view of Miller so that it comprises a user device having an axial duct in communication with an opening thereof, said user device having a coupler corresponding with the opening of said user device, said user device having a needle adapter to inject the pharmacological fluid to a user or adapted to connect to a receptacle for administration of the pharmacological fluid in order to enable successful fluid transfer of a liquid drug through the safety device as taught by Zinger.
Py teaches an aseptic connector for fluid transfer (Figs. 1-3, feat. 10; ¶0040) comprising identical first and second deflecting membranes (18, 30; ¶0040-0041). When connecting and transferring fluid, the first and second membranes are opposite to each other and in mutual contact (Figs. 2A-3) such that their open spaces, or channels, are coaxial to each other and allow for fluid flow through the connector (¶0047). The deflecting membranes may be dome-shaped (¶0012). Py teaches that such identical deflecting membranes in opposite mutual contact with each other advantageously form an annular, fluid-tight seal when engaged to each other, which maintains a hermetic seal during fluid transfer (¶0028-0029). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the assembly disclosed by Guala in view of Miller and in further view of Zinger so that the first membrane and the second membrane being identical and opposite and in mutual contact and so that the channels of the first membrane and the second membrane being coaxial and defining at least a portion of a flow path through the safety device as taught by Py in order to form an annular, fluid-tight seal and ensure a hermetic seal during fluid transfer.
Regarding claim 14, Guala in view of Miller, in further view of Zinger, and in further view of Py discloses the assembly of claim 13. As discussed above, Guala discloses that the first coupler of the safety device has a female luer-lock attachment (Figs. 2-3, feats. 4, 7, and 8; ¶0035) and that the second coupler of the safety device has a male luer-lock attachment (Figs. 2-3, feats. 3, 5, 6, and 9; ¶0035). As discussed above, Miller teaches that the coupler of the syringe comprises a male luer-lock connector (Fig. 4, feat. 78; Col. 7, line 27 – Col. 8, line 20) for coupling to a female luer-lock fitting. As discussed above, Zinger teaches that the coupler of the user device comprises a female luer-lock connector (Figs. 1-2, feat. 32; ¶0017). Therefore, Guala in view of Miller, in further view of Zinger, and in further view of Py further discloses that the coupler of said needleless syringe has a male luer-lock connector, wherein the coupler of said user device has a female luer-lock connector, wherein the first coupler of said safety device has a female luer-lock attachment, wherein the second coupler of said safety device has a male luer-lock attachment.
Regarding claim 15, Guala in view of Miller, in further view of Zinger, and in further view of Py discloses the assembly of claim 13. As discussed above, Miller teaches that the tip of the syringe (Fig. 4, feat. 56) acts as a compression element to push the membrane (32) from the sealed configuration (Fig. 3) to the compressed open configuration (Fig. 4; Col. 7, line 27 – Col. 8, line 20). Therefore, Guala in view of Miller, in further view of Zinger, and in further view of Py further discloses that said first compression element comprises a tip of the coupler of said needleless syringe that is adapted to push the first membrane to the compressed open position when the coupler of the needleless syringe is coupled to the second coupler of said safety device.
Regarding claim 16, Guala in view of Miller, in further view of Zinger, and in further view of Py discloses the assembly of claim 13. As discussed above, Py teaches that the deflecting membranes (Fig. 1, feats. 18 and 30) may be dome-shaped (¶0012), in a similar manner to the semi-body shaped membranes of the claimed invention. Therefore, Guala in view of Miller, in further view of Zinger, and in further view of Py further discloses that each of the first membrane and the second membrane has a semi-body shape.
Regarding claim 17, Guala in view of Miller, in further view of Zinger, and in further view of Py discloses the assembly of claim 13. Guala further discloses that the second membrane (Figs. 2-3, feat. 15) is seated in the axial duct of the body (2; ¶0039). Miller further teaches that the first membrane (Figs. 3-4, feat. 32) is seated within the axial bore (14) of the body of the device (12; Col. 4, line 56 – Col. 5, line 23; Col. 5, lines 62-67). Therefore, Guala in view of Miller, in further view of Zinger, and in further view of Py further discloses that the axial duct of said safety device has a seat for the first membrane and the second membrane.
Regarding claim 18, Guala in view of Miller, in further view of Zinger, and in further view of Py discloses the assembly of claim 17. Guala further discloses a lid with a first portion (Annotated fig. 1, feat. B) inserted in the axial duct of said safety device (2) and a second portion (Annotated fig. 1, feat. C) comprising the first coupler (4) of said safety device.
Regarding claim 19, Guala in view of Miller, in further view of Zinger, and in further view of Py discloses the assembly of claim 18. Guala discloses that the second membrane (Figs. 2-3, feat. 15) is retained and seated between the first portion of the lid (Annotated fig. 1, feat. B) and a shoulder in the axial duct of the safety device (Annotated fig. 1, feat. D). Miller further teaches that the first membrane is retained and seated (Figs. 3-4, feat. 48; Col. 5, lines 8-24) between a rear portion of the valve body (28; Col. 4, lines 30-55) inserted into the axial bore (14) and a shoulder (Figs. 3-4, feat. 64) in the axial bore (Col. 5, lines 62-67). Therefore, Guala in view of Miller, in further view of Zinger, and in further view of Py further discloses that the seat is defined by the first portion of said lid and by a portion of the axial duct of said safety device.
Regarding claim 20, Guala in view of Miller, in further view of Zinger, and in further view of Py discloses the assembly of claim 13, and Guala further discloses that the second membrane pushes the cannula (Figs. 2-3, feat. 6) to a non-operating position (¶0045).
Regarding claim 21, Guala in view of Miller, in further view of Zinger, and in further view of Py discloses the assembly of claim 20, and Guala further discloses that said safety device comprises a stop adapted to stop the cannula in the non-operating position (Figs. 2-3, feat. 14; ¶0037 and 0044), the stop having at least one stop tooth positioned in the axial duct of said safety device (14) and a radial tab positioned on the cannula (13; ¶0037), the radial tab adapted to stop against the at least one stop tooth when the cannula is in the non-operating position (¶0037).
Regarding claim 22, Guala in view of Miller, in further view of Zinger, and in further view of Py discloses the assembly of claim 16. As discussed above, Py teaches that the deflecting membranes (Fig. 1, feats. 18 and 30) may be dome shaped (¶0012). Bells may also be generally dome shaped, so Py teaches that the deflecting membranes may be bell shaped. Py further teaches that each deflecting membrane has a face (Figs. 1-3, feats. 20 and 32; ¶0045) opposite from an aperture (40, 46; ¶0046) with an empty space or channel extending therebetween, such that the channels form a continuously flow path when the faces of the deflecting membranes are in contact with each other (Figs. 2A-3, feats. 20 and 32). Therefore, Guala in view of Miller, in further view of Zinger, and in further view of Py further discloses that each of the first membrane and the second membrane have a bell shape, the channel of the first membrane extends centrally therethrough from the through hole of the first respective membrane to a face of the first membrane opposite the through hole of the first membrane, the face of the first membrane contacting a corresponding face of the second membrane,
Response to Arguments
Applicant’s arguments, see pages 6-9 of Applicant’s Remarks, field 07/17/25, with respect to the rejections of claims 13-15 and 17-21 under 35 U.S.C. 103 as being unpatentable over Guala in view of Miller, and in further view of Zinger and of claim 16 in further view of Pan have been fully considered and are persuasive in light of the amendments. Accordingly, the rejections have been withdrawn. However, upon further search and consideration, new grounds of rejection have been made as indicated above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781