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 1-4, 7, 11, 14-18, 20, 22-24 are rejected under 35 U.S.C. 103 as being unpatentable by Ichikawa et al. (US 4774963 A) over Denning et al. (US 20130018311 A1).
Regarding Claim 1, Ichikawa discloses a plunger kit (Operating unit 2: gasket 4 + Plunger 3, Fig 1) comprising: a piston (gasket 4, Fig 6) configured to be slidably inserted into a liquid medicine storage chamber (100, See annotated image 1) of a syringe main body part (collection container 1, Fig 1) (Col. 4, lines 20-30: “a columnar gasket 4 of resilient material abutting and slidable against the inner peripheral wall of the container 1, or the structure shown in FIG. 4 (…) plunger adapted for sliding in the tubular body”), and a plunger rod (Plunger 3; Fig 1, 5a) mountable to the piston (4) (Col. 4, lines 19-20: “a plunger 3 is operatively connected as by fitting same to the rear side of a columnar gasket 4”); wherein the plunger rod (3) has a rod main body (104, Annotated image 1) that extends in an axial direction (Col. 6, Lines 51-57; plunger (3) extends in the axial direction along the axial communication passage as shown in Fig 1) and transmits drive force to the piston (4) (Col. 14, lines 52-54; as the plunger 3 and the gasket 4 are connected, a force exerted by the pushing or pulling of the plunger 3 will be transmitted to the gasket 4, causing the gasket 4 to slide), and a mounting part (forward end or head 35, Fig 5a) that projects from a tip end of the rod main body (104, Annotated Fig 1) and is for mounting the plunger rod (3) to the piston (4) (Col. 5, lines 53-54: “the forward end or head of the plunger 3 may be mounted as by fitting in an axial communication passage in the gasket 4”);
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the mounting part includes a shaft part (neck 33, Fig 5a) that projects from a tip end part (108, Annotated Fig 2) of the rod main body (104, Annotated image 1) to a tip end side (109, Annotated Fig 2) with a substantially constant diameter (Annotated Fig 2), the shaft part (33) being a solid body (shaft part 33 is a solid body since it has a length, width and depth or thickness), an engagement part (111, annotated Fig 2) that projects from a tip end part (109) of the shaft part (33) in a radial direction and forms an engagement surface (110, Annotated Fig 2) formed substantially perpendicular to the axial direction annotated Fig 2), and a conical part (conical part 106 of head 35, annotated Fig 2; Col 6, lines 4-6) disposed on a tip end side (107, Annotated Fig 2) of the engagement part (111, Annotated Fig 2) and reduced in diameter in a tapered manner toward a tip end (See Fig 6 and annotated Fig 2 below) of the mounting part (35);
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the outer diameter of the engagement part (D1, annotated Fig 2) substantially coincides with an outer diameter of a base end of the conical part (Same: D1, annotated Fig 2); a recess (a communication opening 43, Fig 6) is formed on the piston (4), the recess having an opening part (opening part 114 of communication opening 43, Annotated Fig 3) opened in a base end direction (Annotated Fig 3), a narrow part (Narrow lower section 113 of Gasket 4, Annotated Fig 3) communicating with a tip end side of the opening part (116, Annotated Fig 3) and extending in the axial direction (Annotated Fig 3), and a storage part (storage part 112, Annotated Fig 3) communicating with a tip end side of the narrow part (117, Annotated Fig 3) and capable of storing the engagement part and the conical part (106, Fig 6: engagement part and the conical part are stored in the storage part), the storage part being formed in a hollow shape (Fig 6: storage part is a hollow shape in the form of a cavity);
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the piston (4) has a first side wall (119, Annotated Fig 4) part forming the storage part (112), and a second side wall part (120, Annotated Fig 4) forming the narrow part (113) and thicker than the first side wall part (Annotated Fig 4); a length of the second side wall part (121, Annotated Fig 4) in the axial direction is 10% to 40% of an entire length of the piston (118, Annotated Fig 4) in the axial direction (Note: The axial length of the piston 4 is smaller than 8x the axial length of the second side wall. The second side wall represents (1/8) *100 =12.5% of the piston length. Therefore, the second side wall falls between range of 10-40%; See annotated image below);
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Ichikawa further discloses the conical part (106) includes an area increased in diameter conically (Area increased in diameter seen from D2 to D1, Annotated Fig 2), the area increasing in diameter conically has one side portion with a first cut-out part (recess 355a, Annotated Fig 2) and another side portion with a second cut-out part (recess 355b, Annotated Fig 2, 10); and are formed in an arc shape along an outer periphery of the conical part in a front view (Annotated Fig 10: Frontal view); an outer diameter of the engagement part (111) coincides with an outer diameter of a base end of the conical part (OD of tip 107 is shared by both ethe conical part 106 and the engagement part 111; Annotated Fig 2).
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However, Ichikawa is silent regarding the first cut-out part and the second cut-out part are formed by cutting out areas projecting beyond a diameter of the shaft part; the engagement part being formed in a shape that gradually decreases in size toward the tip end of the mounting part until an outer diameter of the engagement part coincides with an outer diameter of a base end of the conical part and wherein the shape of the engagement part is reduced in thickness in a tapered manner in the radial direction.
Denning teaches a plunger kit (Fig 59) comprising a plunger rod (inner core 842+ barb 866, Fig 59) having a mounting part (barb 866, Fig 57); a piston (stopper 830, Fig 59); a conical part (895, Annotated Fig 12) a first cut-out part (893, Annotated Fig 9) and a second cut-out part (cut out opposite to 893, Annotated Fig 9) are formed by cutting out areas projecting beyond a diameter of a shaft part (stem 890, Fig 57); an engagement part (part 894 of finger 892, Annotated Fig 9) being formed in a shape that gradually decreases in size toward the tip end of the mounting part (866, Annotated Fig 9)) until an outer diameter of the engagement part coincides with an outer diameter of a base end of the conical part (Annotated fig 12: OD where the engagement part and conical part coincides) and wherein the shape of the engagement part (894) is reduced in thickness in a tapered manner in the radial direction (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 device of Ichikawa with similar cutouts, gradually decreasing shape of engagement parts and tapered decrease in thickness as taught by Denning to optimize the engagement between components, reducing the insertion force required to connect to the piston into the gasket communication opening when being pushed through the narrow section of gasket ([0275]).
Regarding Claim 2, Ichikawa/Denning discloses the plunger kit according to claim 1. Ichikawa discloses wherein the narrow part (113, Annotated Fig 5) extends in the axial direction with a substantially uniform diameter (D4, Annotated Fig 5).
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Regarding Claim 3, Ichikawa/Denning discloses the plunger kit according to claim 1. Ichikawa discloses wherein an outer diameter (D5) of the shaft part (33) is equal to or smaller than an inner diameter of the narrow part (D4, Annotated Fig 6).
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Regarding Claim 4, Ichikawa/Denning discloses the plunger kit according to claim 1. Ichikawa discloses wherein the piston (4) has a ring- shaped protrusion (rib 413, Fig 6) on an outer peripheral surface of the second side wall part, the ring-shaped protrusion abutting against an inner wall (105, annotated image 1) of the liquid medicine storage chamber (100, annotated image 1; Col 6, lines 33-38: “The gasket 4 has the shape of a column having locally enlarged portions to facilitate sliding and prevent the gasket 4 from contacting with the container 1 in its entirety. The rearward end of the gasket has a rib 413 adapted for intimately contacting with and sliding on the collection container.”; (Col. 14, lines 52-54: “a plunger and a gasket, said gasket being operatively connected to said plunger for sliding in intimate contact on an inner wall”); of the syringe main body part (1).
Regarding Claim 7, Ichikawa/Denning discloses the plunger kit according to claim 1. Ichikawa discloses wherein the engagement parts comprises a pair of the engagement parts that are provided spaced apart from each other by 180 ° in the circumferential direction (See annotated Fig below).
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Regarding Claim 11, Ichikawa/Denning discloses the plunger kit according to claim 1. Ichikawa discloses the engagement part (111), but is silent regarding the engagement part is a pair of the engagement parts formed to project in an arrowhead shape.
Denning teaches a plunger kit (Fig 59) comprising a plunger rod (inner core 842+ barb 866, Fig 59); an engagement part (894 of each finger 892, Annotated Fig 9) a piston (stopper 830, Fig 59) a first cut-out part (893, Annotated Fig 9) and a second cut-out part (cut out opposite to 893, Annotated Fig 9) are formed by cutting out areas projecting beyond a diameter of a shaft part (890) the engagement part is a pair of the engagement parts (pair of engagement parts 894, Annotated Fig 9) formed to project in an arrowhead shape (engagement part project in an arrowhead shape, Annotated Fig 9).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Ichikawa/Denning with similar engagement parts projecting arrowhead shape as taught by Denning for the purpose of improve the engagement between components, reducing the insertion force required to connect to the piston into the gasket communication opening when being pushed through the narrow section of gasket ([0275]).
Regarding Claim 14, Ichikawa/Denning discloses a syringe kit comprising: a plunger kit (Operating unit 2: gasket 4 + Plunger 3, Fig 1) according to claim 1; Ichikawa further discloses a syringe main body part (collection container 1, Fig 1) having a liquid medicine storage chamber (100 , annotated image 1) configured to store liquid medicine (Col 12 , lines 43-49; “The collector was charged with a heparin solution of 1,000 units/ml; Therefore, the device can be configured to store liquid medicine), a nozzle (101, annotated image 1) provided on a tip end of the liquid medicine storage chamber (102, annotated image 1) , and a cap (plug 19, Fig 1) that seals a tip end opening part of the nozzle (103, See annotated 1 image; Col 4, lines 54-56: “the forward end 15 or 16 may preferably be kept in a sterilized state by a plug 19 of resilient material shown in FIG. 1”) , wherein the piston (4) is slidable in the liquid medicine storage chamber (Col. 4, lines 20-30: “a columnar gasket 4 of resilient material abutting and slidable against the inner peripheral wall of the container 1, or the structure shown in FIG. 4 (…) plunger adapted for sliding in the tubular body”)
Regarding Claim 15, Ichikawa/Denning discloses the syringe kit according to claim 14; Ichikawa further discloses and liquid medicine filled (Col 12 , lines 43-49: “The collector was charged with a heparin solution of 1,000 units/ml; Therefore, the device can be configured to store liquid medicine) in the liquid medicine storage chamber (100 , See annotated image 1) , wherein the piston (4) is disposed so as to be slidable in the liquid medicine storage chamber (Col. 4, lines 20-30: “a columnar gasket 4 of resilient material abutting and slidable against the inner peripheral wall of the container 1, or the structure shown in FIG. 4 (…) plunger adapted for sliding in the tubular body”).
Ichikawa is silent regarding the syringe being prefilled.
Denning teaches a prefilled syringe ([0272];[0278]) comprising a plunger kit (Fig 59) comprising a prefilled syringe ([0278]); a plunger rod (inner core 842+ barb 866, Fig 59) ; a piston (stopper 830, Fig 59)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Ichikawa/Denning to be prefilled as taught by Denning for the purpose of reducing implementation time and avoid human error ([0272];[0278])
Regarding Claim 16, Ichikawa discloses a plunger kit (Operating unit 2: gasket 4 + Plunger 3, Fig 1) comprising: a piston (gasket 4, Fig 6) configured to be slidably inserted into a liquid medicine storage chamber (100, See annotated image 1) of a syringe main body part (collection container 1, Fig 1) (Col. 4, lines 20-30: “a columnar gasket 4 of resilient material abutting and slidable against the inner peripheral wall of the container 1, or the structure shown in FIG. 4 (…) plunger adapted for sliding in the tubular body”), and a plunger rod (Plunger 3; Fig 1, 5a) mountable to the piston (4) (Col. 4, lines 19-20: “a plunger 3 is operatively connected as by fitting same to the rear side of a columnar gasket 4”); wherein the plunger rod (3) has a rod main body (104, Annotated image 1) that extends in an axial direction (Col. 6, Lines 51-57; plunger (3) extends in the axial direction along the axial communication passage as shown in Fig 1) and transmits drive force to the piston (4) (Col. 14, lines 52-54; as the plunger 3 and the gasket 4 are connected, a force exerted by the pushing or pulling of the plunger 3 will be transmitted to the gasket 4, causing the gasket 4 to slide), and a mounting part (forward end or head 35, Fig 5a) that projects from a tip end of the rod main body (104, Annotated Fig 1) and is for mounting the plunger rod (3) to the piston (4) (Col. 5, lines 53-54: “the forward end or head of the plunger 3 may be mounted as by fitting in an axial communication passage in the gasket 4”); the mounting part includes a shaft part (neck 33, Fig 5a) that projects from a tip end part (108, Annotated Fig 2) of the rod main body (104, Annotated image 1) to a tip end side (109, Annotated Fig 2) with a substantially constant diameter (Annotated Fig 2), the shaft part (33) being a solid body (shaft part 33 is a solid body since it has a length, width and depth or thickness), an engagement part (111, annotated Fig 2) that projects from a tip end part (109) of the shaft part (33) in a radial direction and forms an engagement surface (110, Annotated Fig 2) formed substantially perpendicular to the axial direction annotated Fig 2), and a conical part (conical part 106 of head 35, annotated Fig 2; Col 6, lines 4-6) disposed on a tip end side (107, Annotated Fig 2) of the engagement part (111, Annotated Fig 2) and reduced in diameter in a tapered manner toward a tip end (See Fig 6 and annotated Fig 2 below) of the mounting part (35); the outer diameter of the engagement part (D1, annotated Fig 2) substantially coincides with an outer diameter of a base end of the conical part (Same: D1, annotated Fig 2); a recess (a communication opening 43, Fig 6) is formed on the piston (4), the recess having an opening part (opening part 114 of communication opening 43, Annotated Fig 3) opened in a base end direction (Annotated Fig 3), a narrow part (Narrow lower section 113 of Gasket 4, Annotated Fig 3) communicating with a tip end side of the opening part (116, Annotated Fig 3) and extending in the axial direction (Annotated Fig 3), and a storage part (storage part 112, Annotated Fig 3) communicating with a tip end side of the narrow part (117, Annotated Fig 3) and capable of storing the engagement part and the conical part ( 106, Fig 6: engagement part and the conical part are stored in the storage part), the storage part being formed in a hollow shape (Fig 6: storage part is a hollow shape in the form of a cavity); the piston (4) has a first side wall (119, Annotated Fig 4) part forming the storage part (112), and a second side wall part (120, Annotated Fig 4) forming the narrow part(113) and thicker than the first side wall part (Annotated Fig 4).
Ichikawa further discloses the conical part (106) includes an area increased in diameter conically (Area increased in diameter seen from D2 to D1, Annotated Fig 2), the area increasing in diameter conically has one side portion with a first cut-out part (recess 355a, Annotated Fig 2) and another side portion with a second cut-out part (recess 355b, Annotated Fig 2, 10); and are formed in an arc shape along an outer periphery of the conical part in a front view (Annotated Fig 10: Frontal view); an outer diameter of the engagement part (111) coincides with an outer diameter of a base end of the conical part (OD of tip 107 is shared by both ethe conical part 106 and the engagement part 111; Annotated Fig 2).
However, Ichikawa is silent regarding the first cut-out part and the second cut-out part are formed by cutting out areas projecting beyond a diameter of the shaft part; the engagement part being formed in a shape that gradually decreases in size toward the tip end of the mounting part until an outer diameter of the engagement part coincides with an outer diameter of a base end of the conical part and wherein the shape of the engagement part is reduced in thickness in a tapered manner in the radial direction.
Denning teaches a plunger kit (Fig 59) comprising a plunger rod (inner core 842+ barb 866, Fig 59) having a mounting part (barb 866, Fig 57); a piston (stopper 830, Fig 59); a conical part (895, Annotated Fig 12) a first cut-out part (893, Annotated Fig 9) and a second cut-out part (cut out opposite to 893, Annotated Fig 9) are formed by cutting out areas projecting beyond a diameter of a shaft part (stem 890, Fig 57); an engagement part (part 894 of finger 892, Annotated Fig 9) being formed in a shape that gradually decreases in size toward the tip end of the mounting part (866, Annotated Fig 9)) until an outer diameter of the engagement part coincides with an outer diameter of a base end of the conical part (Annotated fig 12: OD where the engagement part and conical part coincides) and wherein the shape of the engagement part (894) is reduced in thickness in a tapered manner in the radial direction (Annotated Fig 9).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Ichikawa with similar cutouts, gradually decreasing shape of engagement parts and tapered decrease in thickness as taught by Denning for the purpose of improve the engagement between components, reducing the insertion force required to connect to the piston into the gasket communication opening when being pushed through the narrow section of gasket ([0275]).
Regarding Claim 17, Ichikawa/Denning discloses the plunger kit according to claim 16. Ichikawa discloses wherein the narrow part (113, Annotated Fig 5) extends in the axial direction with a substantially uniform diameter (D4, Annotated Fig 5), and wherein an outer diameter (D5) of the shaft part (33) is equal to or smaller than an inner diameter of the narrow part (D4, Annotated Fig 6).
Regarding Claim 18, Ichikawa/Denning discloses the plunger kit according to claim 17. Ichikawa discloses wherein the piston (4) has a ring- shaped protrusion (rib 413, Fig 6) on an outer peripheral surface of the second side wall part, the ring-shaped protrusion abutting against an inner wall (105, annotated image 1) of a liquid medicine storage chamber (100, annotated image 1) of the syringe main body part (1) (Col 6, lines 33-38: “The gasket 4 has the shape of a column having locally enlarged portions to facilitate sliding and prevent the gasket 4 from contacting with the container 1 in its entirety. The rearward end of the gasket has a rib 413 adapted for intimately contacting with and sliding on the collection container.”; (Col. 14, lines 52-54: “a plunger and a gasket, said gasket being operatively connected to said plunger for sliding in intimate contact on an inner wall”).
Regarding Claim 20, Ichikawa discloses a syringe (Fig 1) comprising a plunger kit (Operating unit 2: gasket 4 + Plunger 3, Fig 1) comprising: a piston (gasket 4, Fig 6) configured to be slidably inserted into a liquid medicine storage chamber (100, See annotated image 1) of a syringe main body part (collection container 1, Fig 1) (Col. 4, lines 20-30: “a columnar gasket 4 of resilient material abutting and slidable against the inner peripheral wall of the container 1, or the structure shown in FIG. 4 (…) plunger adapted for sliding in the tubular body”), and a plunger rod (Plunger 3; Fig 1, 5a) mountable to the piston (4) (Col. 4, lines 19-20: “a plunger 3 is operatively connected as by fitting same to the rear side of a columnar gasket 4”); wherein the plunger rod (3) has a rod main body (104, Annotated image 1) that extends in an axial direction (Col. 6, Lines 51-57; plunger (3) extends in the axial direction along the axial communication passage as shown in Fig 1) and transmits drive force to the piston (4) (Col. 14, lines 52-54; as the plunger 3 and the gasket 4 are connected, a force exerted by the pushing or pulling of the plunger 3 will be transmitted to the gasket 4, causing the gasket 4 to slide), and a mounting part (forward end or head 35, Fig 5a) that projects from a tip end of the rod main body (104, Annotated Fig 1) and is for mounting the plunger rod (3) to the piston (4) (Col. 5, lines 53-54: “the forward end or head of the plunger 3 may be mounted as by fitting in an axial communication passage in the gasket 4”); the mounting part includes a shaft part (neck 33, Fig 5a) that projects from a tip end part (108, Annotated Fig 2) of the rod main body (104, Annotated image 1) to a tip end side (109, Annotated Fig 2) with a substantially constant diameter (Annotated Fig 2), the shaft part (33) being a solid body (shaft part 33 is a solid body since it has a length, width and depth or thickness), an engagement part (111, annotated Fig 2) that projects from a tip end part (109) of the shaft part (33) in a radial direction and forms an engagement surface (110, Annotated Fig 2) formed substantially perpendicular to the axial direction annotated Fig 2), and a conical part (conical part 106 of head 35, annotated Fig 2; Col 6, lines 4-6) disposed on a tip end side (107, Annotated Fig 2) of the engagement part (111, Annotated Fig 2) and reduced in diameter in a tapered manner toward a tip end (See Fig 6 and annotated Fig 2 below) of the mounting part (35); the outer diameter of the engagement part (D1, annotated Fig 2) substantially coincides with an outer diameter of a base end of the conical part (Same: D1, annotated Fig 2); a recess (a communication opening 43, Fig 6) is formed on the piston (4), the recess having an opening part (opening part 114 of communication opening 43, Annotated Fig 3) opened in a base end direction (Annotated Fig 3), a narrow part (Narrow lower section 113 of Gasket 4, Annotated Fig 3) communicating with a tip end side of the opening part (116, Annotated Fig 3) and extending in the axial direction (Annotated Fig 3), and a storage part (storage part 112, Annotated Fig 3) communicating with a tip end side of the narrow part (117, Annotated Fig 3) and capable of storing the engagement part and the conical part ( 106, Fig 6: engagement part and the conical part are stored in the storage part), the storage part being formed in a hollow shape (Fig 6: storage part is a hollow shape in the form of a cavity); the piston (4) has a first side wall (119, Annotated Fig 4) part forming the storage part (112), and a second side wall part (120, Annotated Fig 4) forming the narrow part(113) and thicker than the first side wall part (Annotated Fig 4), a syringe main body part (collection container 1) having a liquid medicine storage chamber (100 , annotated image 1) with a liquid medicine ( heparin solution ;Col 12 , lines 43-49; “The collector was charged with a heparin solution of 1,000 units/ml; Therefore, the device can be configured to store liquid medicine), a nozzle (101, annotated image 1) provided on a tip end of the liquid medicine storage chamber(102, annotated image 1), and a cap (plug 19, Fig 1) that seals a tip end opening part of the nozzle (103, See annotated 1 image below; Col 4, lines 54-56: “the forward end 15 or 16 may preferably be kept in a sterilized state by a plug 19 of resilient material shown in FIG. 1”)
Ichikawa further discloses the conical part (106) includes an area increased in diameter conically (Area increased in diameter seen from D2 to D1, Annotated Fig 2), the area increasing in diameter conically has one side portion with a first cut-out part (recess 355a, Annotated Fig 2) and another side portion with a second cut-out part (recess 355b, Annotated Fig 2, 10); and are formed in an arc shape along an outer periphery of the conical part in a front view (Annotated Fig 10: Frontal view); an outer diameter of the engagement part (111) coincides with an outer diameter of a base end of the conical part (OD of tip 107 is shared by both ethe conical part 106 and the engagement part 111; Annotated Fig 2);
However, Ichikawa is silent regarding the first cut-out part and the second cut-out part are formed by cutting out areas projecting beyond a diameter of the shaft part; the engagement part being formed in a shape that gradually decreases in size toward the tip end of the mounting part until an outer diameter of the engagement part coincides with an outer diameter of a base end of the conical part and wherein the shape of the engagement part is reduced in thickness in a tapered manner in the radial direction; the syringe being prefilled.
Denning teaches a prefilled syringe ([0272];[0278]) comprising a plunger kit (Fig 59) comprising a plunger rod (inner core 842+ barb 866, Fig 59) having a mounting part (barb 866, Fig 57); a piston (stopper 830, Fig 59); a conical part (895, Annotated Fig 12) a first cut-out part (893, Annotated Fig 9) and a second cut-out part (cut out opposite to 893, Annotated Fig 9) are formed by cutting out areas projecting beyond a diameter of a shaft part (stem 890, Fig 57); an engagement part (part 894 of finger 892, Annotated Fig 9) being formed in a shape that gradually decreases in size toward the tip end of the mounting part (866, Annotated Fig 9)) until an outer diameter of the engagement part coincides with an outer diameter of a base end of the conical part (Annotated fig 12: OD where the engagement part and conical part coincides) and wherein the shape of the engagement part (894) is reduced in thickness in a tapered manner in the radial direction (Annotated Fig 9).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Ichikawa to be prefilled and with cutouts and similar shape of the engagements part gradually decreasing in size and tapered decrease in thickness as taught by Denning for the purpose of reducing implementation time and avoid human error ([0272];[0278]); and improve the engagement between components, reducing the insertion force required to connect to the piston into the gasket communication opening when being pushed through the narrow section of gasket ([0275]).
Regarding Claim 22, Ichikawa/Denning discloses the plunger kit according to claim 1, wherein a number of cut-out parts is two, the two cut-out parts being the first cut-out part and the second cut-out part (two cut outs, first and second cutout, as modified with the teaching of Denning, see claim 1).
Regarding Claim 23, Ichikawa/Denning the plunger kit according to claim 1. Ichikawa is silent wherein the engagement parts are formed so as not to project beyond the shaft part in a width direction.
Denning teaches a plunger kit (Fig 59) comprising a plunger rod (inner core 842+ barb 866, Fig 59) ; a piston (stopper 830, Fig 59); a shaft (890) and engagement parts (894) wherein the engagement parts (894) are formed so as not to project beyond the shaft part (890) in a width direction (width of engagement part (WE) is smaller than width of shaft (WS), Annotated Fig 11).
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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 Ichikawa/Denning with similar engagement parts as taught by Denning for the purpose of improve the engagement between components, reducing the insertion force required to connect to the piston into the gasket communication opening when being pushed through the narrow section of gasket ([0275]).
Regarding Claim 1, Ichikawa discloses a plunger kit (Operating unit 2: gasket 4 + Plunger 3, Fig 1) comprising: a piston (gasket 4, Fig 6) configured to be slidably inserted into a liquid medicine storage chamber (100, See annotated image 1) of a syringe main body part (collection container 1, Fig 1) (Col. 4, lines 20-30: “a columnar gasket 4 of resilient material abutting and slidable against the inner peripheral wall of the container 1, or the structure shown in FIG. 4 (…) plunger adapted for sliding in the tubular body”), and a plunger rod (Plunger 3; Fig 1, 5a) mountable to the piston (4) (Col. 4, lines 19-20: “a plunger 3 is operatively connected as by fitting same to the rear side of a columnar gasket 4”); wherein the plunger rod (3) has a rod main body (104, Annotated image 1) that extends in an axial direction (Col. 6, Lines 51-57; plunger (3) extends in the axial direction along the axial communication passage as shown in Fig 1) and transmits drive force to the piston (4) (Col. 14, lines 52-54; as the plunger 3 and the gasket 4 are connected, a force exerted by the pushing or pulling of the plunger 3 will be transmitted to the gasket 4, causing the gasket 4 to slide), and a mounting part (forward end or head 35, Fig 5a) that projects from a tip end of the rod main body (104, Annotated Fig 1) and is for mounting the plunger rod (3) to the piston (4) (Col. 5, lines 53-54: “the forward end or head of the plunger 3 may be mounted as by fitting in an axial communication passage in the gasket 4”); the mounting part includes a shaft part (neck 33, Fig 5a) that projects from a tip end part (108, Annotated Fig 2) of the rod main body (104, Annotated image 1) to a tip end side (109, Annotated Fig 2) with a substantially constant diameter (Annotated Fig 2), the shaft part (33) being a solid body (shaft part 33 is a solid body since it has a length, width and depth or thickness), an engagement part (111, annotated Fig 2) that projects from a tip end part (109) of the shaft part (33) in a radial direction and forms an engagement surface (110, Annotated Fig 2) formed substantially perpendicular to the axial direction annotated Fig 2), and a conical part (conical part 106 of head 35, annotated Fig 2; Col 6, lines 4-6) disposed on a tip end side (107, Annotated Fig 2) of the engagement part (111, Annotated Fig 2) and reduced in diameter in a tapered manner toward a tip end (See Fig 6 and annotated Fig 2 below) of the mounting part (35); the outer diameter of the engagement part (D1, annotated Fig 2) substantially coincides with an outer diameter of a base end of the conical part (Same: D1, annotated Fig 2); a recess (a communication opening 43, Fig 6) is formed on the piston (4), the recess having an opening part (opening part 114 of communication opening 43, Annotated Fig 3) opened in a base end direction (Annotated Fig 3), a narrow part (Narrow lower section 113 of Gasket 4, Annotated Fig 3) communicating with a tip end side of the opening part (116, Annotated Fig 3) and extending in the axial direction (Annotated Fig 3), and a storage part (storage part 112, Annotated Fig 3) communicating with a tip end side of the narrow part (117, Annotated Fig 3) and capable of storing the engagement part and the conical part (106, Fig 6: engagement part and the conical part are stored in the storage part), the storage part being formed in a hollow shape (Fig 6: storage part is a hollow shape in the form of a cavity); the piston (4) has a first side wall (119, Annotated Fig 4) part forming the storage part (112), and a second side wall part (120, Annotated Fig 4) forming the narrow part (113) and thicker than the first side wall part (Annotated Fig 4); a length of the second side wall part (121, Annotated Fig 4) in the axial direction is 10% to 40% of an entire length of the piston (118, Annotated Fig 4) in the axial direction (Note: The axial length of the piston 4 is smaller than 8x the axial length of the second side wall. The second side wall represents (1/8) *100 =12.5% of the piston length. Therefore, the second side wall falls between range of 10-40%;Annotated Fig 4).
Ichikawa further discloses the conical part (106) includes an area increased in diameter conically (Area increased in diameter seen from D2 to D1, Annotated Fig 2), the area increasing in diameter conically has one side portion with a first cut-out part (recess 355a, Annotated Fig 2) and another side portion with a second cut-out part (recess 355b, Annotated Fig 2, 10); and are formed in an arc shape along an outer periphery of the conical part in a front view (Annotated Fig 10: Frontal view); an outer diameter of the engagement part (111) coincides with an outer diameter of a base end of the conical part (OD of tip 107 is shared by both ethe conical part 106 and the engagement part 111; Annotated Fig 2)
However, Ichikawa is silent regarding the first cut-out part and the second cut-out part are formed by cutting out areas projecting beyond a diameter of the shaft part; the engagement part being formed in a shape that gradually decreases in size toward the tip end of the mounting part until an outer diameter of the engagement part coincides with an outer diameter of a base end of the conical part and wherein the shape of the engagement part is reduced in thickness in a tapered manner in the radial direction.
Denning embodiment of Fig 63, hereinafter Denning-63 teaches an engagement part (1064, Annotated Fig 13) being formed in a shape that gradually decreases in size toward the tip end of the mounting part until an outer diameter of the engagement part coincides with an outer diameter of a base end of the conical part (1065, Annotated Fig 13) (See annotated Fig 13) and wherein the shape of the engagement part (1064) is reduced in thickness in a tapered manner in the radial direction (Annotated Fig 13).
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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 Ichikawa with similar gradually decreasing shape of engagement parts and tapered decrease in thickness as taught by Denning for the purpose of optimize the engagement between components, reducing the insertion force required to connect to the piston into the gasket communication opening when being pushed through the narrow section of gasket ([0275]).
However, Ichikawa/Denning-63 are silent regarding the first cut-out part and the second cut-out part are formed by cutting out areas projecting beyond a diameter of the shaft part.
Denning embodiment of Fig 59, hereinafter Denning-59 teaches a plunger kit (Fig 59) comprising a plunger rod (inner core 842+ barb 866, Fig 59) having a mounting part (barb 866, Fig 57); a piston (stopper 830, Fig 59); a conical part (895, Annotated Fig 12) a first cut-out part (893, Annotated Fig 9) and a second cut-out part (cut out opposite to 893, Annotated Fig 9) are formed by cutting out areas projecting beyond a diameter of a shaft part (stem 890, Fig 57)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Ichikawa with similar cutouts as taught by Denning for the purpose of optimize the engagement between components by further reducing contact area and the insertion force required to connect to the piston into the gasket communication opening when being pushed through the narrow section of gasket ([0275]).
Regarding claim 24, Ichikawa/Denning-63/Denning-59 discloses the plunger kit according to claim 1. Ichikawa discloses wherein the engagement part (111) is a solid body (engagement part 111 has a length width and depth) in which a radial end (radial end which contacts tip end part if the shaft 109, Annotated Fig 2) of the engagement part (111) connects to the shaft part (109) continuously in the radial direction (Annotated Fig 2).
Claims 5 and 19 are rejected under 35 U.S.C. 103 as being unpatentable by Ichikawa et al. (US 4774963 A) over Denning et al. (US 20130018311 A1) in view of Okihara (US 20130012888 A1).
Regarding Claims 5 and 19, Ichikawa/Denning discloses the plunger kit according to claim 1 and 16 respectively. Ichikawa discloses wherein the opening part (opening part 114, Annotated Fig 3) of the recess (43) has a base end part (115, Annotated Fig 3). However, Ichikawa/Denning are silent regarding the base end part extending by a predetermined length with an inner diameter substantially the same as an outer diameter of the engagement part along the axial direction, and a tapered part reduced in diameter from the base end part toward the narrow part.
Okihara discloses the plunger kit according (Plunger 4 + Gasket body 6; Fig 2) wherein the opening part ([0074]: “opening formed at the proximal end of the gasket body 6”) of the recess (inner cavity 60, Fig 7) has a base end part (200, Annotated Fig 7) extending by a predetermined length ( annotated Fig 8) with an inner diameter substantially the same as an outer diameter of the engagement part (73, Fig 16; Annotated Fig 7) along the axial direction, and a tapered part (annular inclined surface 62b, Fig 7) reduced in diameter from the base end part toward the narrow part ([0075]: “as an annular inclined surface 62b the diameter of which increases toward the proximal end thereof”)
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the gasket of device of Ichikawa/Denning with a similar internal shape as the gasket taught by Okihara for the purpose of to improve engagement retention of the plunger in the gasket ([0075]: “to help prevent the plunger-mounting member from separating from the gasket body when the plunger is pulled rearward.”).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable by Ichikawa et al. (US 4774963 A) over Denning et al. (US 20130018311 A1) in view of Quinn (US 20110034882 A1).
Regarding Claim 21, Ichikawa/Denning discloses the plunger kit according to claim 1. Ichikawa/Denning are silent wherein the shape of the engagement part is reduced in thickness in a tapered manner toward the tip end of the mounting part.
Quinn teaches a plunger kit (a plunger rod 14, Fig 7 + stopper 12, Fig 1) wherein the shape of the engagement part (attachment portion 31, Fig 7) is reduced in thickness in a tapered manner toward the tip end of the mounting part (D7> D6, annotated Fig 10; the thickness from the shaft to D7 is reduced towards the tip end, Annotated 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 engagement part of device of Ichikawa/Denning with similar tapered shape as the engagement part taught by Quinn for the purpose of further improve the engagement between components, reducing the insertion force required to connect to the piston into the gasket communication opening when being pushed through the narrow section of gasket ([0096]).
Response to Arguments
Applicant's arguments filed 08/08/2025 have been fully considered but they are not persuasive. Applicant submits that it would not have been obvious to one of ordinary skill in the art to have modified Ichikawa and Denning as recited in claims 1 and 16. Applicant submits that it is impermissible within the framework of section 103 to pick and choose from any one reference only so much of it as will support a given position, to the exclusion of other parts necessary to the full appreciation of what such reference fairly suggests to one of ordinary skill in the art and cannot pick and choose only one aspect of a prior art reference and exclude other aspects of the reference or ignore the central teaching of the reference.
Examiner respectfully disagrees. The combination of the device of Ichikawa with similar cutouts and gradually decreasing shape of engagement parts as taught by Denning can reduce the insertion force required to connect to the piston into the gasket communication opening when being pushed through the narrow section of gasket. Although the function of the syringes differs the combination focuses on the engagement between the piston and the gasket. Modification of engagement parts will not hinder the function of syringe of Ichikawa. Air will still be able to pass through.
Applicant’s arguments with respect to claim 24 has 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. Claim 1 is rejected over Ichikawa et al. (US 4774963 A) in view of embodiments of Fig 63 and embodiment of Fig 59 of Denning et al. (US 20130018311 A1).
Applicant submits that new claim 24 depends from claim 1, and for at least the reasons set forth above as to claim 1, new claim 24 should be allowable. Applicant argument regarding claim 1 have been fully considered but they are not persuasive. Please see examiner response to Claim 1 arguments above. Ichikawa et al. (US 4774963 A) discloses the limitations of claim 24. Please see below:
Ichikawa/Denning-63/Denning-59 discloses the plunger kit according to claim 1. In regard to claim 24, Ichikawa discloses wherein the engagement part (111) is a solid body (engagement part 111 has a length width and depth forming a volume) in which a radial end (radial end which contacts tip end part of the shaft 109, Annotated Fig 2) of the engagement part (111) connects to the shaft part (109) continuously in the radial direction (Annotated Fig 2 above).
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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