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 § 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, 3-4, 7, 10, 23-24, 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (KR 102307817 B1) in view of Caizza (US 5964737 A).
Regarding claim 1, Park discloses an adaptor (Syringe tip 10, Fig 1) for a syringe ([0020]) having a syringe tip (joint tube 33, Fig 3) defining a lumen (1000, Annotated Fig 1) with an opening (1001, Annotated Fig 1) and a needle assembly (Fig 5) having a needle hub (needle member 35, Fig 5) attached to the syringe tip (33), the adaptor (10) comprising: a shaft (leg portion 110, Fig 5) having a proximal end (1003, Annotated Fig 1), a distal end (1004, Annotated Fig 1), and a sidewall (1005, Annotated Fig 1) extending between the proximal end (1003, Annotated Fig 1) and the distal end (1004, Annotated Fig 1) and defining a lumen (liquid passage 300, Fig 5) extending through the shaft (110);
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and a seal (upper part 130 and head 150, Fig 5) that extends from the distal end (1004, Annotated Fig 1) of the shaft (110), wherein the seal (130+150) comprises a sealing surface (surface area of head 150 in contact with inner surface of needle hub, Fig 6) and wherein at least a portion of the shaft (110) is sized and shaped to be inserted in the lumen (1000, Annotated Fig 1) of the syringe tip (33) and create a seal (1001, Annotated Fig 1) with the opening (1001, Annotated Fig 1) of the syringe tip (33), and at least a portion of the seal (130+150) is sized and shaped to be inserted into the needle hub (35) of the needle assembly (Fig 5) to create a seal (1007, Annotated Fig 2) with an inner surface (1008, Annotated Fig 2) of the needle hub (35b), thereby reducing an interior volume of the lumen (1000, Annotated Fig 1) of the syringe tip (33)(open volume of syringe is reduced by insertion of shaft 110) and an interior volume of the needle hub (35) that is filled with medicament contained in the syringe ([0065]; Fig 6 shows the adaptor 10 reducing the interior volume of both the needle hub with seal 130+150 and tip 33 with shaft 110; M is the residual drug left after the reduction).
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Park is silent wherein a plurality of circumferential ridges provided on the sealing surface.
Caizza teaches an adaptor (elastomeric plug 134, Fig 7-8) for a syringe (transfer device 1, Fig 2a-b) comprising a sealing surface (5000, Annotated Fig 9) wherein a plurality of circumferential ridges (5001, Annotated Fig 9) provided on the sealing surface (5000, Annotated Fig 9).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the seal of device of Park with similar material and ridges as taught by Caizza for the purpose of enhancing the sealing capabilities with the benefit of allowed lose tolerances of the seal while further reducing potential dead space of gaps (Col 5 lines 58-65).
Regarding claim 3, Park/Caizza discloses the adaptor of claim 1. Park discloses wherein the seal (130+150) is a circumferential flange extending from the distal end (1004, Annotated Fig 1) of the shaft (110) (See Fig 4).
Regarding claim 4, Park/Caizza discloses the adaptor of claim 3. Park discloses wherein the seal (130+150) has a concave curvature or the outer diameter of the seal tapers in a distal direction (Annotated Fig 3), such that a largest diameter of the seal (130+150) is at a proximal end of the seal (130+150), a smallest diameter of the seal (130+150) is at a distal end (1009, Annotated Fig 3) of the seal (130+150), and the seal (130+150) extends in a proximal direction along the shaft (110) (seal is integral with the shaft and extends in the proximal direction of the shaft; See Fig 4).
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Regarding claim 7, Park/Caizza discloses the adaptor of claim 1. Park discloses wherein a sealing surface of the seal (130+150) has the shape of a cone, a truncated cone, a hemisphere, or a cylinder with a front portion having a flat seal surface (1011, Annotated Fig 4)(Seal 130+150, has the shape of a truncated cone body and a cylinder head ; See Fig 4).
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Regarding claim 10, Park/Caizza discloses the adaptor of claim 1. Park discloses wherein a distal portion of the shaft (110) that is surrounded by the seal (130+150) and positioned in the needle hub (35) has an outer diameter that is greater than an outer diameter of a proximal portion of the shaft (110) that is inserted in the lumen (1000, Annotated Fig 1) of the syringe tip (33) (Shaft 110 is tapered, and its outer diameter increases in the distal direction; the distal end face portion of the shaft 110 that meets the seal proximal face is surrounded by the seal).
Regarding claim 23, Park discloses a syringe body (cylinder 31, Fig 3) comprising: a chamber (1012, Annotated Fig 1) having a syringe tip (joint tube 33, Fig 3) defining a lumen (1000, Annotated Fig 1) having an opening (1001, Annotated Fig 1) through which medicament (drug; [0065]) may be expelled from the chamber (1012, Annotated Fig 1); and an adaptor (syringe tip 10, Fig 1), wherein at least a portion of the shaft (110) of the adaptor is positioned in the lumen (1000, Annotated Fig 1) of the syringe tip (33) and forms a seal (1006, Annotated Fig 1) with the opening of the lumen (1000, Annotated Fig 1).
Park discloses the adaptor (10) according to claim 1 except wherein a plurality of circumferential ridges provided on the sealing surface.
Caizza teaches an adaptor (elastomeric plug 134, Fig 7-8) for a syringe (transfer device 1, Fig 2a-b) comprising a sealing surface (5000, Annotated Fig 9) wherein a plurality of circumferential ridges (5001, Annotated Fig 9) provided on the sealing surface (5000, Annotated Fig 9).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the seal of device of Park with similar material and ridges as taught by Caizza for the purpose of enhancing the sealing capabilities with the benefit of allowed lose tolerances of the seal while further reducing potential dead space of gaps (Col 5 lines 58-65).
Regarding claim 24, Park/Caizza discloses the syringe body of claim 23. Park discloses wherein a length of the shaft (110) that is inserted into the lumen (1000, Annotated Fig 1) of the syringe tip (33) is substantially equal to a length of the lumen of the syringe tip (33) (Fig 5).
Regarding claim 26, Park discloses a syringe comprising: a syringe body (cylinder 31, Fig 3) comprising a chamber (1012, Annotated Fig 1) having a syringe tip (joint tube 33, Fig 3) defining a lumen (1000, Annotated Fig 1) having an opening (1001, Annotated Fig 1) through which medicament (drug; [0065]) may be expelled from the chamber (1012, Annotated Fig 1); a needle hub (needle member 35, Fig 5) having a sidewall (1013, Annotated Fig 4) defining an interior volume (cavity inside needle cap 35b, Fig 5) connected to the syringe tip (33); a needle (injection needle 35a, Fig 5) having a lumen (lumen of needle 35a, Fig 6) in fluid communication with the interior volume (cavity inside needle cap 35b, Fig 5) of the needle hub (35b) and extending from the needle hub (35b); and an adaptor (syringe tip 10, Fig 1), wherein at least a portion of the shaft (110) of the adaptor (10) is positioned in the lumen (1000, Annotated Fig 1) of the syringe tip (33) and forms a seal (1006, Annotated Fig 1) with the opening (1001, Annotated Fig 1) of the lumen (1000, Annotated Fig 1), the seal (130+150) of the adaptor (10) is positioned in the interior volume of the needle hub (cavity inside needle cap 35b, Fig 5) and forms a seal (Seal 1014, Annotated Fig 4) with an inner surface (1015, Annotated Fig 4) of the sidewall (1013, Annotated Fig 4)of the needle hub (35b), and the lumen (liquid passage 300, Fig 5) of the shaft (110) of the adaptor (10) is in fluid communication with the chamber and the lumen of the needle (35a) (See Fig 6).
Park discloses the adaptor (10) according to claim 1 except wherein a plurality of circumferential ridges provided on the sealing surface.
Caizza teaches an adaptor (elastomeric plug 134, Fig 7-8) for a syringe (transfer device 1, Fig 2a-b) comprising a sealing surface (5000, Annotated Fig 9) wherein a plurality of circumferential ridges (5001, Annotated Fig 9) provided on the sealing surface (5000, Annotated Fig 9).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the seal of device of Park with similar material and ridges as taught by Caizza for the purpose of enhancing the sealing capabilities with the benefit of allowed lose tolerances of the seal while further reducing potential dead space of gaps (Col 5 lines 58-65).
Regarding claim 27, Park/Caizza discloses the syringe of claim 26. Park discloses wherein at least a portion of the shaft (110) of the adaptor (10) fills part of a volume of the lumen (1000, Annotated Fig 1) of the syringe tip (33) and the seal (130+150) of the adaptor (10) fills and isolates a portion of the interior volume of the needle hub (35b) that would otherwise be in filled with the medicament (drug) (Please see Fig 6).
Regarding claim 28, Park/Caizza discloses the syringe of claim 26. Park discloses wherein a length of the shaft (110) that is inserted into the lumen (1000, Annotated Fig 1) of the syringe tip (33) is substantially equal to a length of the lumen of the syringe tip (33) (Fig 5-6 shows substantially equal length of shaft 110 and lumen 1000, annotated Fig 1).
Regarding claim 29, Park discloses a method of reducing the dead volume of a syringe having a syringe tip (joint tube 33, Fig 3) defining a lumen (1000, Annotated Fig 1) with an opening (1001, Annotated Fig 1) and a needle assembly having a needle hub (needle cap 35b, Fig 5) attached to the syringe tip (33), the method comprising: providing an adaptor (syringe tip 10, Fig 1); inserting at least a portion of the shaft (110) of the adaptor (10) in the lumen (1000, Annotated Fig 1) of the syringe tip (33); and inserting the seal (130+150) of the adaptor (10) in an interior volume of the needle hub (cavity inside needle cap 35b, Fig 5), wherein a seal (1006, Annotated Fig 1) is provided between the shaft (110) of the adaptor (10) and the opening (1001, Annotated Fig 1) of the syringe tip (33), and a seal (1014, Annotated Fig 4) is provided between the seal (130+150) of the adaptor (10) and an inner surface (1015, Annotated Fig 4) of the needle hub (35b), and the adaptor (10) reduces an interior volume of the lumen (1000, Annotated Fig 1) of the syringe tip (33) and the interior volume of the needle hub (35b) that is filled with medicament (drug) contained in the syringe([0065]; Fig 6 shows the adaptor 10 reducing the interior volume of both the needle hub with seal 130+150 and tip 33 with shaft 110; M is the residual drug left after the reduction).
Park discloses the adaptor (10) according to claim 1 except wherein a plurality of circumferential ridges provided on the sealing surface.
Caizza teaches a method comprising an adaptor (elastomeric plug 134, Fig 7-8) for a syringe (transfer device 1, Fig 2a-b) comprising a sealing surface (5000, Annotated Fig 9) wherein a plurality of circumferential ridges (5001, Annotated Fig 9) provided on the sealing surface (5000, Annotated Fig 9).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the seal of method of Park with similar material and ridges as taught by Caizza for the purpose of enhancing the sealing capabilities with the benefit of allowed lose tolerances of the seal while further reducing potential dead space of gaps (Col 5 lines 58-65).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (KR 102307817 B1) in view of Caizza (US 5964737 A) in further view of Sarnoff (US 3380449 A).
Regarding claim 6, Park/Caizza discloses the adaptor of claim 1. Park is silent regarding wherein the shaft and/or the seal is made of a material that compresses or flexes when the shaft is inserted into the opening of the syringe tip or the seal is inserted in the needle hub, respectively.
Sarnoff teaches an adaptor (stopper 18, Fig 1) wherein the shaft (plug section 28, Fig 2) and/or the seal (flange portion 26, Fig 2) is made of a material that compresses or flexes when the shaft is inserted into the opening (opening 3000, Annotated Fig 6) of the syringe tip (neck 20, Fig 2) or the seal (26) is inserted in the needle hub (conical shield 32 + clamping ring 42), respectively (Col 2, lines 50-65).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the material and fitment of adaptor of device of Park/Caizza with similar material and snug fitment as taught by Sarnoff to prevent medicine leakage (Col 2, lines 50-65).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (KR 102307817 B1) in view of Caizza (US 5964737 A) in further view of Mcconnaughey et al. (US 3091240 A).
Regarding claim 8, Park/Caizza discloses the adaptor of claim 1. Park discloses a diameter (ID-1, Annotated Fig 3) of the lumen (leg portion of channel 300, Annotated Fig 3) of the shaft (110). Park is silent wherein the diameter changes along the length of the adaptor.
Mcconnaughey teaches an adaptor (Fig 9-9a) wherein a diameter (3000, Annotated Fig 7) of the lumen changes along the length of the adaptor (3000, Annotated Fig 7).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the shape of the lumen of shaft the device of Park/Caizza with similar tapered shape decreasing size from the distal end to the proximal end as taught by Mcconnaughey for the purpose of further reduce dead space and improve fluid flow and facilitate needle attachment (Col 2, lines 63-68; Fig 9-9a).
Regarding claim 9, Park/Caizza discloses the adaptor of claim 7. Park discloses wherein a distal portion of the lumen of the shaft (110) that is surrounded by the seal (130+150) and positioned in the needle hub (35). Park is silent wherein the distal portion of the lumen of the shaft has a diameter that is greater than a diameter of a proximal portion of the shaft that is inserted in the lumen of the syringe tip.
Mcconnaughey teaches a distal portion (4000, Annotated Fig 8) of the lumen (4002, Annotated 8) of the shaft (4001, Annotated Fig 8) has a diameter (4003, Annotated Fig 8) that is greater than a diameter of a proximal portion (4004, Annotated Fig 8) of the shaft (4001, Annotated Fig 8)that is inserted in the lumen of the syringe tip (4005, Annotated Fig 8).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the shape of the lumen of shaft the device of Park/Caizza with similar tapered shape decreasing size from the distal end to the proximal end as taught by Mcconnaughey for the purpose of further reduce dead space and improve fluid flow and facilitate needle attachment (Col 2, lines 63-68)
Claim 11, 14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (KR 102307817 B1) in view of Caizza (US 5964737 A) in further view of Heinz et al. (US 20040116869 A1).
Regarding claim 11, Park discloses an adaptor assembly comprising: an adaptor (syringe tip 10, Fig 2).
Park discloses the adaptor (10) according to claim 1 except wherein a plurality of circumferential ridges provided on the sealing surface; a delivery housing to which the adaptor is attached, wherein the delivery housing comprises an open proximal end, a closed distal end, and a sidewall extending between the proximal end and the distal end.
Caizza teaches an adaptor (elastomeric plug 134, Fig 7-8) for a syringe (transfer device 1, Fig 2a-b) comprising a sealing surface (5000, Annotated Fig 9) wherein a plurality of circumferential ridges (5001, Annotated Fig 9) provided on the sealing surface (5000, Annotated Fig 9).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the seal of device of Park with similar material and ridges as taught by Caizza for the purpose of enhancing the sealing capabilities with the benefit of allowed lose tolerances of the seal while further reducing potential dead space of gaps (Col 5 lines 58-65).
Park/Caizza are silent regarding a delivery housing to which the adaptor is attached, wherein the delivery housing comprises an open proximal end, a closed distal end, and a sidewall extending between the proximal end and the distal end.
Heinz teaches a delivery housing (protective cap 26, Fig 4) to which the adaptor (intermediate component 23, Fig 4) is attached ([0052]), wherein the delivery housing (26) comprises an open proximal end (2000, Annotated Fig 5), a closed distal end (2001, Annotated Fig 5), and a sidewall (2002, Annotated Fig 5) extending between the proximal end (2000, Annotated Fig 5) and the distal end (2001, Annotated Fig 5).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Park/Caizza with a similar housing in attachment with the adaptor as taught by Heinz for the purpose of protect the contents of the syringe until a needle is inserted to perform the injection ([0053]).
Regarding claim 14, Park/Caizza/Heinz discloses the adaptor assembly of claim 11. Park is silent wherein an inner sidewall of the delivery housing has a recess having a shape corresponding to a shape of the outer surface of the seal.
Heinz teaches wherein an inner sidewall (2003, Annotated Fig 5) of the delivery housing has a recess (recess 2004, annotated Fig 5 formed at the distal end) having a shape corresponding to a shape of the outer surface of the seal (2005, Annotated Fig 5) (shape of the outer surface of seal 2005 corresponds to the shape of the inner side wall that forms recess 2004).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Park/Caizza/Heinz with similar cap structure having inner surface shape that corresponds to the shape of the seal as taught by Heinz for the purpose of having a tight fitment that prevents medication from leak out of the cap ([0053]).
Regarding claim 20, Park/Caizza/Heinz discloses the adaptor assembly of claim 11. Park is silent wherein a flange adapted to engage threads of a luer lock on the syringe extend radially outward from the open distal end of the delivery housing.
Heinz teaches wherein a delivery housing (cap 6) comprising a flange (helical flange forming the external thread of cap, Fig 2) adapted to engage threads of a luer lock on the syringe (Luer connection 3, [0048]) extend radially outward from the open distal end of the delivery housing ( Fig 2: thread of cap 6 extends outwards from open end of 6).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Park/Caizza/Heinz with of a similar flange and luer lock in threaded connection as taught by Heinz embodiment of Fig 2 for the purpose of provide a reliable attachment of the housing to the syringe ([0047]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (KR 102307817 B1) in view of Caizza (US 5964737 A) in view of Heinz et al. (US 20040116869 A1) in further view of Reid (US 20180126094 A1).
Regarding claim 22, Park/Caizza/Heinz the adaptor assembly of claim 11. Park is silent wherein the delivery housing includes ridges extending radially outward from an outer surface of the sidewall.
Reid teaches a delivery housing (Cap 200, Fig 3) wherein the delivery housing (200) includes ridges (Wings 205, Fig 3) extending radially outward from an outer surface of the sidewall (sidewall 207, Fig 3A).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Park/Caizza/Heinz with similar ridges as taught by Reid to facilitate rotation of the cap ([0041]).
Response to Arguments
Applicant’s arguments with respect to claims 1-29 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant submits that FIGS. 12 and 13 are exemplary of a state in which an adaptor, which may be exemplary adaptor 10 (identified Species 1, FIGS. 2 and 3), adaptor 10a (identified Species 2, FIGS. 4, 5, and 11), and adaptor 10b (identified Species 3, FIGS. 6, 7, and 10), is positioned within an exemplary delivery housing for insertion of the adaptor into a needle hub, while FIGS. 9 to 11 are exemplary of a state in which an adaptor is positioned within an exemplary delivery housing for insertion of the adaptor into a syringe tip, as shown in FIGS. 14A to 14C. For example, "As shown in FIGS. 8-14C, a delivery housing 78, 78 a, 78 b, 78 c may be provided with the adaptor 10, 10 a, 10 b to assist in insertion of the adaptor 10, 10 a, 10 b into either the syringe tip 18 or the needle hub 26 and to prevent the adaptor 10, 10 a, 10 b from being touched during insertion into the syringe tip 20 or the needle hub 26, thereby maintaining the sterility of the fluid path of the syringe 12."1; [0055].
Examiner respectfully disagrees.
Claim 15 is dependent on claim 14. Claim 14 disclose “wherein an inner sidewall of the delivery housing has a recess having a shape corresponding to a shape of the outer surface of the seal.”; therefore, the seal 38 is placed inside delivery housing 78 towards the close distal end 94 when being assembled as shown in Fig 11; 14a-c; [0060].
Claim 15 discloses “(…) wherein frictional and/or compressive forces between the adaptor and the delivery housing are less than the frictional and/or compressive forces between the seal of the adaptor and the inner surface of the sidewall of the needle hub.”; therefore the seal 38 must be inside the end of the side wall 68 of the needle hub 28 and the shaft 36 towards the distal end of the delivery housing 78 as shown in Figs 12 or 13; [0065].
Claims 14 and 15 require different species of the delivery housing and orientation of the adaptor which results in an impermissible combination of embodiments of Fig 11, [0060] and Fig 12-13, [0065]. The withdrawal of claim 15 is maintained.
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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