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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 103
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 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Terumo, WO 2009/084646 A1 (cited on IDS of July 12, 2024) in view of Kirisawa et al, JP 2021-46523 (cited on IDS of July 12, 2024).
Regarding claim 1, Terumo discloses a gasket (1) for use in a syringe (10), the gasket formed to be in liquid-tight and slidable contact with an inside of a plastic outer cylinder of a syringe (11), the gasket comprising: a gasket body (2) including an elastic body (paras [0009]-[0013], Figs. 1-2, 5); and a coating layer (3) provided at least at a part in contact with the syringe (10), the coating layer being an elastic cured coating layer containing a silicone-based resin as a main component (paras [0009]-[0013], [0017], [0020]-[0021], Figs. 1-2, 5) and containing a silane coupling agent (silicone compound, paras [0009]-[0013], [0017], [0020]-[0021], Figs. 1-2, 5), the silicone-based resin that includes a condensate of a reactive silicone having a silanol group at both terminals and has a siloxane bond derived from the silanol group (paras [0009]-[0013], [0017], [0020]-[0021], Figs. 1-2, 5).
Terumo is silent as to the coating layer containing a carbodiimide compound together with the silane coupling agent.
However, Kirisawa, in the same field of art, namely coating films, teaches a coating layer that can be used on an elastic body such as a gasket, where the coating layer being an elastic cured coating layer (layer E) containing a silicone-based resin (ABC) as a main component and containing a carbodiimide compound (D, paras [0005]; [0010]; [0023]-[0026], [0087]-[0088]) together with a silane coupling agent, the silicone-based resin that includes a condensate of a reactive silicone having a silanol group at both terminals and has a siloxane bond derived from the silanol group (B; see paras [0005]; [0010]; [0023]-[0026], [0087]-[0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the coating layer of Terumo with the carbodiimide compound as taught by Kirisawa in order to provide the stated advantages of hardening and strengthening the coating layer since the carbodiimide compounds were known in the art and would lead to predictable results and have a reasonable expectation of success.
Regarding claims 2-3, Terumo as modified by Kirisawa discloses the gasket for use in a syringe according to claim 1, and Kirisawa further teaches wherein the carbodiimide compound is a carbodiimide having two or more carbodiimide groups or is a polycarbodiimide (paras [0005]; [0010]; [0023]-[0026], [0087]-[0088]).
Regarding claims 4-5, Terumo as modified by Kirisawa discloses the gasket for use in a syringe according to claim 1, and Kirisawa further teaches wherein the silicone-based resin or the silane coupling agent has a functional group that reacts with a carbodiimide group of the carbodiimide compound (paras [0005]; [0010]; [0023]-[0026], [0087]-[0088]; see also para [0097]); wherein the functional group that reacts with a carbodiimide group is at least one selected from a carboxyl group, a hydroxyl group, an amino group, an amide group, a sulfonate group, and a phosphate group (paras [0005]; [0010]; [0023]-[0026], [0087]-[0088]; see also para [0097]).
Regarding claim 6, Terumo as modified by Kirisawa discloses the gasket for use in a syringe according to claim 1, and Terumo teaches wherein the silane coupling agent is at least one selected from an alkylalkoxysilane, a phenylalkoxysilane, an aminoalkylalkoxysilane, and a glycidoxyalkylalkoxysilane (paras [0009]-[0013], [0017], [0020]-[0021]; in particular para [0013]).
Regarding claim 7, Terumo as modified by Kirisawa discloses the gasket for use in a syringe according to claim 1, and Terumo teaches wherein the silane coupling agent contains an alkylalkoxysilane or a phenylalkoxysilane as a first silane coupling agent, and further contains an aminoalkylalkoxysilane or a glycidoxyalkylalkoxysilane as a second silane coupling agent (paras [0009]-[0013], [0017], [0020]-[0021]; in particular para [0013]).
Regarding claim 8, Terumo as modified by Kirisawa discloses the gasket for use in a syringe according to claim 1, and Terumo teaches wherein the silane coupling agent contains an alkylalkoxysilane or a phenylalkoxysilane as a first silane coupling agent (paras [0009]-[0013], [0017], [0020]-[0021]), and further contains an aminoalkylalkoxysilane as a second silane coupling agent (paras [0009]-[0013], [0017], [0020]-[0021]) and a glycidoxyalkylalkoxysilane as a third silane coupling agent (paras [0009]-[0013], [0017], [0020]-[0021]; in particular para [0013]).
Regarding claim 9, Terumo as modified by Kirisawa discloses the gasket for use in a syringe according to claim 1, and Terumo teaches wherein the elastic cured coating layer (3) is a thermosetting elastic cured coating layer (para [0017]).
Regarding claim 10, Terumo as modified by Kirisawa discloses the gasket for use in a syringe according to claim 1, wherein the coating layer (3) has a thickness of 1 to 30 μm (para [0017]).
Regarding claim 11, Terumo discloses a syringe (10, Figs. 1-2, 5) comprising: a plastic outer cylinder (11); the gasket for use in a syringe according to claim 1 (see rejection for claim 1 above), the gasket (1) slidably accommodated in the plastic outer cylinder (11, see paras [0020]-[0021]); and a plunger (17) attached to or attachable to the gasket (paras [0009]-[0013], [0017], [0020]-[0021]).
Regarding claim 12, Terumo as modified by Kirisawa discloses the syringe according to claim 11, and Terumo teaches the syringe (10 filled with a drug solution (26, para [0020], Fig. 5).
Regarding claims 13-14 and 20, Terumo as modified by Kirisawa discloses the gasket/syringe according to claims 1 and 11, and Terumo teaches wherein the gasket body (2) is a butyl rubber gasket body (para [0011]) and the plastic outer cylinder is polyolefin outer cylinder or a cyclic polyolefin outer cylinder (para [0021]).
Regarding claim 15, Terumo as modified by Kirisawa discloses the gasket for use in a syringe according to claim 1, and Kirisawa teaches wherein the carbodiimide compound is a polycarbodiimide terminated with a water soluble polymer or a hydrophilic group-modified polycarbodiimide compound (paras [0005]; [0010]; [0023]-[0026], [0087]-[0088]; see also para [0097]).
Regarding claim 16, Terumo as modified by Kirisawa discloses the gasket for use in a syringe according to claim 1, and Terumo teaches wherein the reactive silicone having a silanol group at both terminals is both terminals silanol polydimethylsiloxane, both terminals silanol polyalkylphenylsiloxane, both terminals silanol polydiphenylsiloxane, or both terminals silanol diphenylsiloxane-dimethylsiloxane copolymer (paras [0013]-[0015]).
Regarding claim 17, Terumo as modified by Kirisawa discloses the gasket for use in a syringe according to claim 1, and Kirisawa teaches wherein the carbodiimide compound is a polycarbodiimide terminated with a water soluble polymer or a hydrophilic group-modified polycarbodiimide compound, the reactive silicone having a silanol group at both terminals is both terminals silanol polydimethylsiloxane, both terminals silanol polyalkylphenylsiloxane, both terminals silanol polydiphenylsiloxane, or both terminals silanol diphenylsiloxane-dimethylsiloxane copolymer, the silane coupling agent contains an alkylalkoxysilane or a phenylalkoxysilane as a first silane coupling agent, and further contains an aminoalkylalkoxysilane as a second silane coupling agent and a glycidoxyalkylalkoxysilane as a third silane coupling agent and the coating layer contains a catalyst capable of promoting thermal curing may be used as an additive (paras [0005]; [0010]; [0023]-[0026], [0087]-[0088]; see also para [0097]).
Regarding claim 18, Terumo as modified by Kirisawa discloses the gasket for use in a syringe according to claim 1, and Kirisawa teaches wherein the carbodiimide compound is a hydrophilic group-modified polycarbodiimide compound, the reactive silicone having a silanol group at both terminals is both terminals silanol polydimethylsiloxane or both terminals silanol polyalkylphenylsiloxane, the silane coupling agent contains methyltrimethoxysilane, 3-aminopropyltriethoxysilane and 3-glycidoxypropyltrimethoxysilane and the coating layer contains dioctyldilaurate (paras [0005]; [0010]; [0023]-[0026], [0087]-[0088]; see also para [0097]).
Regarding claim 19, Terumo as modified by Kirisawa discloses the gasket for use in a syringe according to claim 1, and Kirisawa teaches wherein the carbodiimide compound is a hydrophilic group-modified polycarbodiimide compound, the reactive silicone having a silanol group at both terminals is both terminals silanol polydimethylsiloxane or both terminals silanol polyalkylphenylsiloxane, the silane coupling agent contains phenyltriethoxysilane, 3-aminopropyltriethoxysilane and 3-glycidoxypropyltrimethoxysilane and the coating layer contains dioctyldilaurate (paras [0005]; [0010]; [0023]-[0026], [0087]-[0088]; see also para [0097]).
Regarding claim 21, Terumo discloses a method for manufacturing a gasket (1) for use in a syringe (10, 11, Figs. 1-2, 5) comprising, a process for preparing a gasket body made of an elastic body (2) and a process for forming a coating layer on an outer surface of the gasket body (paras [0009]-[0013], [0017], [0020]-[0021]), wherein the process for forming a coating layer (3) includes a coating liquid preparation process in which a coating liquid contains a reactive silicone having silanol groups at both ends, a silane coupling agent, and a catalyst capable of promoting thermal curing, a coating liquid application process in which the coating liquid is applied to the outer surface of the gasket body and a drying process for drying the gasket body to which the coating liquid has been applied (paras [0009]-[0013], [0017], [0020]-[0021]).
Terumo is silent as to the coating layer containing a carbodiimide compound.
However, Kirisawa, in the same field of art, namely coating films, teaches a coating layer that can be used on an elastic body such as a gasket, where the coating layer being an elastic cured coating layer (layer E) containing a silicone-based resin (ABC) as a main component and containing a carbodiimide compound (D, paras [0005]; [0010]; [0023]-[0026], [0087]-[0088]) together with a silane coupling agent, the silicone-based resin that includes a condensate of a reactive silicone having a silanol group at both terminals and has a siloxane bond derived from the silanol group (B; see paras [0005]; [0010]; [0023]-[0026], [0087]-[0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the coating layer of Terumo with the carbodiimide compound as taught by Kirisawa in order to provide the stated advantages of hardening and strengthening the coating layer since the carbodiimide compounds were known in the art and would lead to predictable results and have a reasonable expectation of success.
Regarding claim 22, Terumo as modified by Kirisawa discloses the method for manufacturing a gasket for use in a syringe according to claim 21, and Terumo teaches wherein the process of applying the coating liquid is performed after the gasket body (2) is heat-treated (paras [0017]; [0025]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATRINA M STRANSKY whose telephone number is (571)270-3843. The examiner can normally be reached Monday-Friday 8:30 am-5:00 pm EST.
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/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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