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 1-8, 10-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph et al. (US 10391253 B1) in view of Grabenkort (US 5785682 A).
Regarding claim 1, Joseph discloses a syringe (syringe 200, Fig 2A), comprising a barrel (syringe barrel 210, Fig 2A) defining a hollow chamber (lumen inside barrel 210, Fig 2A) for holding a fluid volume (volume of medication; Col 7, lines 26-38), and an outlet end (end of wall extension 242; Col 6, line 67- Col 7, line 5) provided at a distal end (Fig 2A) of the barrel (210); a syringe chamber (chamber inside needle hub 260, Fig 8B) for receiving at least part of the outlet end (end of wall extension 242; Col 6, line 67- Col 7, line 5) of the syringe (200); wherein: the syringe (200) comprises a plunger (plunger 240 + plunger piston 250.2, Fig 4), comprising at a distal end a plunger end face (flat end surface 252.2, Fig 4): the plunger (240+250.2) is arranged to be inserted into the barrel (210) at a proximal end (plunger receiving end 230, Fig 1 is a proximal end) of the barrel (210); the plunger (240+250.2) is arranged to be axially moved in the barrel (210) between a retracted position (Fig 1) and an inserted position (Fig 9B); in the retracted position (Fig 1), the plunger end face (252.2) and at least part of the barrel (210) distal to the plunger end face (252.2) define a volume available for fluid in the barrel (210) (Retracted position of Fig 1 comprises a volume of medication to be injected): in the inserted position (Fig 9B) the plunger end face (252.2) is substantially aligned with an external axially outward facing end face of the outlet end (external axially outward facing end of wall extension 242;Fig 2A)of the syringe (200) such that the volume available for fluid in the barrel (210) and in the outlet end (end of wall extension 242) is substantially zero (Col 7, lines 8-13).
Joseph is silent regarding a syringe/cap combination comprising a syringe cap for sealing off the outlet end of the syringe, the syringe cap comprising: a cap body, comprising a cap base; and a skirt part comprising a substantially cylindrical wall extending from the cap base and defining, with the cap base; wherein the cap body further comprises a protrusion extending from the cap base into the syringe chamber, which protrusion is arranged to be at least partially inserted into the outlet end of the syringe, wherein: the protrusion of the cap body is arranged to be at least partially inserted into the outlet end of the syringe,
Grabenkort teaches a syringe/cap combination (Fig 10)comprising: a syringe (first syringe assembly; abstract, Fig 10), comprising a barrel (barrel 110, Fig 10) defining a hollow chamber (chamber 130, Fig 10)for holding a fluid volume (drug M, Fig 10), and an outlet end (end of nozzle 102, Fig 10) provided at a distal end (Fig 10)of the barrel (110); and a syringe cap (removable closure 128, Fig 10) for sealing off the outlet end (nozzle 102, Fig 10) of the syringe (syringe assembly, Fig 10), the syringe cap comprising: a cap body (removable closure 128, Fig 10), comprising a cap base (cap base 1000, Annotated Fig 1); and a skirt part (skirt part 1001, Annotated Fig 1) comprising a substantially cylindrical wall (wall 1002, Annotated Fig 1) extending from the cap base (1000, Annotated Fig 1) and defining, with the cap base (1000, Annotated Fig 1), a syringe chamber (syringe chamber 1003, Annotated Fig 1) for receiving at least part of the outlet end (102) of the syringe (syringe assembly, Fig 10); wherein the cap body (128) further comprises a protrusion (internal stem 129, Fig 10) extending from the cap base (1000, Annotated Fig 1) into the syringe chamber (1003, Annotated Fig 1), which protrusion (129) is arranged to be at least partially inserted into the outlet end (102) of the syringe (syringe assembly, Fig 10)
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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 Joseph to incorporate a similar cap as taught by Grabenkort for the purpose of sealing the syringe before use (Col 7, lines 46-51).
Regarding claim 2, Joseph/Grabenkort discloses the syringe/cap combination according to claim 1. Joseph is silent wherein an outer wall of the cylindrical wall is provided with at least one outwardly radially extending connection element for engaging the syringe.
Grabenkort teaches wherein an outer wall (outer wall 1004, Annotated Fig 1) of the cylindrical wall (1002) is provided with at least one outwardly radially extending connection element (exterior lug or flange 108, Fig 10) for engaging the syringe (syringe assembly, Fig 10).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Joseph/Grabenkort with similar cap structure as taught by Grabenkort for the purpose of for the purpose of threadingly engaging the female thread on the annular collar at the delivery end of the syringe and sealing the syringe before use (Col 7, lines 46-51).
Regarding claim 3, Joseph/Grabenkort discloses the syringe/cap combination according to claim 2. Joseph is silent wherein the radially extending connection element is shaped as a thread.
Grabenkort teaches wherein the radially extending connection element (108) is shaped as a thread (col 7, lines 46-51).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Joseph/Grabenkort with similar cap structure as taught by Grabenkort for the purpose of for the purpose of threadingly engaging the female thread on the annular collar at the delivery end of the syringe and sealing the syringe before use (Col 7, lines 46-51).
Regarding claim 4, Joseph/Grabenkort discloses the syringe/cap combination according to claim1. Joseph is silent wherein an inner wall of the cylindrical wall of the skirt part is tapered towards the cap body.
Grabenkort teaches wherein an inner wall (Inner wall 1005, Annotated Fig 1) of the cylindrical wall (1002, Annotated Fig 1) of the skirt part (1001, Annotated Fig 1) is tapered towards the cap body (Annotated Fig 2).
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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 Joseph/Grabenkort with similar cap structure as taught by Grabenkort for the purpose of for the purpose of threadingly engaging the female thread on the annular collar at the delivery end of the syringe and sealing the syringe before use (Col 7, lines 46-51).
Regarding claim 5, Joseph/Grabenkort discloses the syringe/cap combination according claim 1. Joseph is silent wherein the inner wall of the cylindrical wall has a substantially smooth surface.
Grabenkort teaches wherein the inner wall of the cylindrical wall has a substantially smooth surface (Inner wall 1005 is free from projections or unevenness, Fig 10).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Joseph/Grabenkort with similar cap structure as taught by Grabenkort for the purpose of for the purpose of reducing friction between inner and outer walls of mating components, threadingly engaging the cap and sealing the syringe before use (Col 7, lines 46-51).
Regarding claim 6, Joseph/Grabenkort discloses the syringe/cap combination according claim 1. Joseph is silent wherein the protrusion has at a distal end thereof a substantially continuous convex surface.
Grabenkort wherein the protrusion (129) has at a distal end thereof (distal end 1006, Annotated Fig 3) a substantially continuous convex surface (Annotated Fig 3).
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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 Joseph/Grabenkort with similar cap structure as taught by Grabenkort for the purpose of facilitation insertion of the cap and sealing the syringe before use (Col 7, lines 46-51).
Regarding claim 7, Joseph/Grabenkort discloses the syringe/cap combination according to claim 6. Joseph is silent wherein the protrusion has at the distal end thereof a substantially continuously convexly curved surface.
Grabenkort teaches wherein the protrusion (129) has at the distal end thereof (distal end 1006, Annotated Fig 3) a substantially continuously convexly curved surface (Annotated Fig 3).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Joseph/Grabenkort with similar cap structure as taught by Grabenkort for the purpose of facilitation insertion of the cap and sealing the syringe before use (Col 7, lines 46-51).
Regarding claim 8, Joseph/Grabenkort discloses the syringe/cap combination according to claim 7. Joseph is silent wherein the protrusion has at the distal end thereof a substantially hemispherical surface.
Grabenkort teaches wherein the protrusion (129) has at the distal end thereof (distal end 1006, Annotated Fig 3) a substantially hemispherical surface (Annotated Fig 3).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Joseph/Grabenkort with similar cap structure as taught by Grabenkort for the purpose of facilitation insertion of the cap and sealing the syringe before use (Col 7, lines 46-51).
Regarding claim 10, Joseph/Grabenkort discloses the syringe/cap combination according to claim 1. Joseph discloses wherein: the syringe (200) further comprises a shoulder (3002, Annotated Fig 5) at an axial distance (3003, Annotated Fig 5), from the outlet end (end of wall extension 242), and a barrel skirt (3004, Annotated Fig 5) comprising a substantially cylindrical barrel skirt wall (wall of skirt 3004 is substantially cylindrical, Annotated Fig 5) extending from the shoulder (3002, Annotated Fig 5) away from the proximal end of the barrel (210); and the barrel skirt (3004, Annotated Fig 5) defines together with the shoulder (3002, Annotated Fig 5) a cap chamber (3005, Annotated Fig 5) for receiving at least part of the cap (Chamber 3005 is structurally capable of receiving a part of a cap).
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Regarding claim 11, Joseph/Grabenkort discloses the syringe/cap combination according to claim 10. Joseph is silent wherein, when at least part of the cap is inserted into the cap chamber of the barrel, an annular seal is provided between part of an outer wall of the outlet end and part of the inner wall of the cylindrical wall of the skirt part of the cap, the annular seal sealing off a sealed volume between an outer surface of the outlet end and the cap.
Grabenkort teaches wherein, when at least part of the cap (128) is inserted into the cap chamber (1012, Annotated Fig 4) of the barrel (110), an annular seal (1013, Annotated Fig 4) is provided between part of an outer wall (1007, Annotated Fig 5) of the outlet end (102) and part of the inner wall (1005, Annotated Fig 1) of the cylindrical wall (1002, Annotated Fig 1) of the skirt part (1002, Annotated Fig 1) of the cap (128), the annular seal (1013, Annotated Fig 4) sealing off a sealed volume (1014, Annotated Fig 4) between an outer surface (1015, Annotated Fig 4) of the outlet end (102) and the cap (128).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Joseph/Grabenkort with similar cap structure as taught by Grabenkort for the purpose of for the purpose of threadingly engaging the cap and sealing the syringe before use (Col 7, lines 46-51).
Regarding claim 12, Joseph/Grabenkort discloses the syringe/cap combination according to claim 11. Joseph is silent wherein when the annular seal is achieved, a volume of the inserted in the outlet end is greater than or equal to the sealed volume.
Grabenkort teaches wherein when the annular seal (1013, Annotated Fig 4) is achieved, a volume of the protrusion (volume of protrusion 129, Fig 10) inserted in the outlet end (102) is greater than or equal to the sealed volume (volume of protrusion 129 is greater than sealed volume 1014, Annotated Fig 4).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Joseph/Grabenkort with similar cap structure as taught by Grabenkort for the purpose of for the purpose of sealing the syringe before use (Col 7, lines 46-51).
Regarding claim 13, Joseph/Grabenkort discloses the syringe/cap combination according to claim 1. Joseph is silent wherein an inner wall of the cylindrical barrel skirt wall comprises one or more substantially radially extending protrusions protruding into the cap chamber.
Grabenkort teaches wherein an inner wall of the cylindrical barrel skirt wall (inner wall of collar 104, Fig 10) comprises one or more substantially radially extending protrusions (protrusion resulted from interior female thread 106, Fig 10) protruding into the cap chamber (1012, Annotated Fig 4).
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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 Joseph/Grabenkort with similar cap structure as taught by Grabenkort for the purpose of for the purpose of threadingly engaging the cap and sealing the syringe before use (Col 7, lines 46-51).
Regarding claim 14, Joseph/Grabenkort discloses the syringe/cap combination according to claim 13. Joseph is silent wherein one or more of the one or more radially extending protrusions protruding into the cap chamber are shaped as one or more threads.
Grabenkort teaches wherein one or more of the one or more radially extending protrusions (protrusion resulted from interior female thread 106, Fig 10) protruding into the cap chamber (1012, Annotated Fig 4) are shaped as one or more threads (Col 7, lines 39-45).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Joseph/Grabenkort with similar cap structure as taught by Grabenkort for the purpose of for the purpose of threadingly engaging the cap and sealing the syringe before use (Col 7, lines 46-51).
Regarding claim 15, Joseph/Grabenkort discloses the syringe/cap combination according to claim 1. Joseph discloses wherein an outer wall (3000, Annotated Fig 5) of the outlet end (end of wall extension 242) is tapered towards the distal end (3001, Annotated Fig 5) of the barrel (210).
Regarding claim 17, Joseph/Grabenkort discloses a kit of parts, comprising: the syringe/cap combination according to claim 1. Joseph discloses regarding the kit comprising a needle part (needle hub 260 + needle 262, Fig 8A-B), comprising a needle hub (needle hub 260, Fig 8A-B) comprising a hub base (3006, Annotated Fig 6) and a needle (needle 262, Fig 8B) extending through the needle hub (260); wherein the needle part (260+262) comprises a hub skirt (3007, Annotated Fig 7) extending from the needle hub (260) away from the needle (262), and wherein the hub skirt (3007, Annotated Fig 1) and the hub base (3006, Annotated Fig 1) define a hub chamber (inner chamber of needle hub, Fig 8B) arranged to receive at least part of the outlet end (end of wall extension 242) of the syringe (200).
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Regarding claim 18, Joseph/Grabenkort discloses the kit of parts according to claim 17. Joseph discloses wherein, when the needle part (260+262) has received at least part of the outlet end (end of wall extension 242) of the syringe (200) and the plunger (250.2+ 240) is in the inserted position (Fig 8B), the plunger end face (252.2), the end face of the outlet end (end of wall extension 242) and the hub base (3006, Annotated Fig 6) are substantially aligned (3008, Annotated Fig 6).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Joseph et al. (US 10391253 B1) in view of Grabenkort (US 5785682 A) in further view of Beccaro et al. (US 20100181218 A1).
Regarding claim 19, Joseph/Grabenkort discloses a method for filling and capping a syringe (syringe 200, Fig 1; From Joseph ) with a fluid medicament (medication, Col 7, lines 18-22; From Joseph), comprising: providing the syringe/cap combination of claim 1. Joseph discloses filling the syringe (200) with a volume of fluid medicament (medication, Col 7, lines 18-22);
Joseph is silent regarding capping the syringe with the syringe cap wherein, while capping the syringe part of the cap is inserted into the volume of fluid medicament such that at least substantially no air is left in the syringe in contact with the fluid medicament.
Grabenkort teaches a method for filling and capping a syringe (syringe assembly, Fig 10) with a fluid medicament (reconstituted drug solution MX, Fig 14), comprising: providing the syringe/cap combination of claim 1; (syringe assembly, Fig 10); filling the syringe (syringe assembly, Fig 10) with a volume of fluid medicament (volume of reconstituted drug solution MX, Fig 14); capping the syringe (syringe assembly, Fig 14) with a the syringe cap (closure 128, Fig 14) wherein, while capping the syringe (syringe assembly, Fig 14), part of the cap (128) is inserted into the volume of fluid medicament (volume of MX, Fig 14).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Joseph/Grabenkort to incorporate a similar cap as taught by Grabenkort for the purpose of sealing the syringe before use (Col 7, lines 46-51).
Joseph/Grabenkort are silent regarding such that at least substantially no air is left in the syringe in contact with the fluid medicament.
Beccaro teaches a method of filling a syringe (syringe 2, Fig 2) such that at least substantially no air is left in the syringe in contact with the fluid medicament ([0062]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Joseph/Grabenkort with a similar vacuum step as taught by Beccaro for the purpose of eliminating the presence of air in the syringe ([0062]).
Response to Arguments
Applicant’s arguments with respect to claims 1-8, 10-15, and 17-19 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.
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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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783