DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This office action is responsive to the amendment filed 22 April 2025.
Claim 3 is canceled.
Claims 1, 12, and 19 are amended.
Claims 1, 2, and 4-20 are presently pending in this application.
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 2-6, 11, 13-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Prasad et al. (US Patent Publication No. 20220401654 A1), hereinafter Prasad, in view of Laurence et al. (US Patent Publication No. 20230064423 A1), hereinafter Laurence.
Regarding claim 1, Prasad discloses a prefilled syringe (Prasad: Fig. 1, syringe assembly 10 is pre-filled; para. 0075) comprising: a syringe barrel (Fig. 1, syringe barrel 12) comprising a proximal end (Fig. 2A, proximal end 34) and a distal end (Fig. 2A, distal end 32) and defining a chamber (Fig. 2A, chamber 36), the syringe barrel (12) having an opening (Fig. 2A, end 34 is shown having an opening) at the proximal end (34); and a plunger assembly (Fig. 2A, comprising plunger rod 14 and stopper 16) inserted through the opening (opening at 34) and axially movable within the chamber (stopper 16 is moveably disposed within chamber 36; para. 0076) of the syringe barrel (12), the plunger assembly (14 and 16) including: a plunger rod (Fig. 2A, plunger rod 14) comprising an elongated body (Fig. 2A, plunger rod body 64) and extending between a proximal end (34) and a distal end (32); and a stopper (Fig. 2A, stopper 16) attached to the distal end (Fig. 2A, first end 60) of plunger rod (14) and positioned within the barrel chamber (36); wherein the stopper (16) comprises a blended material (stopper 16 comprises thermoplastic elastomer with added filler; para. 0100) including an elastomeric material (thermoplastic elastomer; para. 0100) and an intermixed material (filler; para. 0100) having a coefficient of thermal expansion lower (filler has low thermal expansion coefficient compared to the high thermal expansion coefficient of the thermoplastic elastomer; para. 0100) than the elastomeric material (para. 0100).
Prasad does not expressly disclose the blended material of the stopper has a coefficient of thermal expansion matching a coefficient of thermal expansion of the syringe barrel or lower than the coefficient of thermal expansion of the syringe barrel.
Laurance teaches a blended material (Laurance: Fig. 3A, container closure 11 comprises a blended material; para. 0030) of a stopper (Fig. 3A, container closure 30) has a coefficient of thermal expansion (para. 0030) matching a coefficient of thermal expansion of a syringe barrel (Fig. 3A, container 10) or lower than the coefficient of thermal expansion of the syringe barrel (10). The barrel (10) of Laurance is comprised of glass or a polymeric material (polypropylene and glass; para. 0038) and the stopper (30) is comprised of a blend of an elastomeric material (bromobutyl rubber; para. 0037) and an intermixed material (Beta-eucryptite or graphene; para. 0039). Since the barrel and stopper of Laurance comprise materials and blends of materials that are the same as the materials of the barrel and stopper of the claimed invention, a skilled artisan would have concluded that the coefficient of thermal expansion of each of the barrel and stopper of Laurance has the same characteristics as the claimed invention, namely, the stopper has a coefficient of thermal expansion matching a coefficient of thermal expansion of the syringe barrel or lower than the coefficient of thermal expansion of the syringe barrel.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Prasad such that the blended material of the stopper has a coefficient of thermal expansion matching a coefficient of thermal expansion of the syringe barrel or lower than the coefficient of thermal expansion of the syringe barrel as taught by Laurance in order to prevent possible failure of container closure integrity and preserving the contents of the syringe when stored at lower temperatures (Laurance: para. 0030).
Regarding claim 2, Prasad in view of Laurance discloses syringe above.
Prasad does not expressly disclose the intermixed material has a negative coefficient of thermal expansion.
Laurance teaches an intermixed material (material is blended with elastomeric material; para. 0030) that has a negative coefficient of thermal expansion (the material has a negative thermal expansion coefficient; para. 0030).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the intermixed material of Prasad such that the intermixed material has a negative coefficient of thermal expansion as taught by Laurance in order to prevent possible failure of container closure integrity and preserving the contents of the syringe when stored at lower temperatures (Laurance: para. 0030).
Regarding claim 4, Prasad in view of Laurance discloses the syringe above.
Prasad does not expressly disclose the stopper is configured to expand at room temperature or at cold storage temperatures of 0°C and lower, so as to maintain a closure integrity between the stopper and the syringe barrel.
Laurance teaches a stopper (Laurance: 30) is configured to expand at room temperature (upon warming to ambient temperature, closure 30 expands; para. 0030) so as to maintain a closure integrity between the stopper (30) and the syringe barrel (closure 30 expands at ambient temperature to maintain the seal; para. 0030).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the stopper of Prasad such that the stopper is configured to expand at room temperature or at cold storage temperatures of 0°C and lower, so as to maintain a closure integrity between the stopper and the syringe barrel as taught by Laurance in order to maintain the seal at ambient temperatures (Laurance: para. 0030).
Regarding claim 5, Prasad in view of Laurance discloses the syringe above.
Prasad does not expressly disclose the intermixed material comprises graphene, a hexagonal boron nitride (coronene) compound, ScF3 compound, ZrW208, or beta- eucryptite and Ca2RuO4.
Laurance teaches the intermixed material (para. 0030) comprises graphene, a hexagonal boron nitride (coronene) compound, ScF3 compound, ZrW208, or beta- eucryptite and Ca2RuO4 (Beta-eucryptite or graphene; para. 0039).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the intermixed material of Prasad such that the intermixed material comprises graphene, a hexagonal boron nitride (coronene) compound, ScF3 compound, ZrW208, or beta- eucryptite and Ca2RuO4 as taught by Laurance in order to allow the intermixed material to have a negative coefficient of thermal expansion (Laurance: para. 0039).
Regarding claim 6, Prasad teaches the syringe above.
Prasad does not expressly disclose the stopper comprises an inert coating applied to at least a portion of an outer surface thereof.
Laurance teaches a stopper (Laurance: 30) comprising an inert coating (closure 30 is coated with an inert film; para. 0045) applied to at least a portion of an outer surface thereof (30 surface is coated with film; para. 0045).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the stopper such that it comprises an inert coating applied to at least a portion of an outer surface thereof as taught by Laurance in order to prevent contact of the blended material with the medicament; para. 0045).
Regarding claim 8, Prasad in view of Laurance discloses the syringe above, wherein the syringe barrel (12) is composed of a glass substrate (barrel 12 is formed from glass; para. 0072).
Regarding claim 9, Prasad in view of Laurance discloses the syringe above, wherein the syringe barrel is composed of a polymeric substrate (barrel 12 is formed from polypropylene; para. 0072).
Regarding claim 10, Prasad in view of Laurance discloses the syringe above, wherein the stopper (16) comprises a molded stopper (stopper 16 is injection molded; para. 0122). “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Regarding claim 11, Prasad in view of Laurance discloses the syringe above, further comprising a distal end cap (Prasad: syringe assembly 10 may include a cap; para. 0075) positioned over a nozzle (Fig. 2A, luer tip 42) at the distal end (32) of the barrel chamber (36).
Prasad does not expressly disclose the distal end cap comprises a blended material including a polymeric material and an intermixed material having a coefficient of thermal expansion lower than the polymeric material.
Laurance teaches a distal end cap (Laurance: Fig. 8B, vial stopper 81) comprises a blended material (Fig. 8B, comprising elastomeric body 82 and material 84) including a polymeric material (elastomeric body 82 can comprise polyisoprene; para. 0037) and an intermixed material (material 84; para. 0030) having a coefficient of thermal expansion lower than the polymeric material (para. 0030).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the distal end cap of Prasad such that the distal end cap comprises a blended material including a polymeric material and an intermixed material having a coefficient of thermal expansion lower than the polymeric material as taught by Laurance in order to seal the syringe (para. 0033 and 0048) and prevent possible failure of container closure integrity and preserving the contents of the syringe when stored at lower temperatures (Laurance: para. 0030).
Regarding claim 12, Prasad discloses an apparatus (Fig. 1, syringe assembly 10) for storing and/or delivering a fluid (para. 0016), the apparatus (10) comprising: a container (Fig. 2A, syringe barrel 12) having a proximal end (Fig. 2A, proximal end 34) and a distal end (Fig. 2A, distal end 32) and defining a chamber (Fig. 2A, chamber 36), the container (12) having an opening (Fig. 2A, end 34 is shown having an opening) at the proximal end (36); and a sealing component (Fig. 2A, stopper 16) positioned at least partially within the chamber (36) such that at least a portion of the sealing component (16) forms an interference fit with the container (stopper 16 forms an interference fit with barrel 12; para. 0103); wherein the sealing component (16) comprises a blended material (stopper 16 comprises thermoplastic elastomer with added filler; para. 0100) including an elastomeric material (thermoplastic elastomer; para. 0100) and an intermixed material (filler; para. 0100) having a coefficient of thermal expansion lower than the elastomeric material (filler has low thermal expansion coefficient compared to the high thermal expansion coefficient of the thermoplastic elastomer; para. 0100).
Prasad does not expressly disclose the blended material of the stopper has a coefficient of thermal expansion matching a coefficient of thermal expansion of the syringe barrel or lower than the coefficient of thermal expansion of the syringe barrel.
Laurance teaches a blended material (Laurance: Fig. 3A, container closure 11 comprises a blended material; para. 0030) of a stopper (Fig. 3A, container closure 30) has a coefficient of thermal expansion (para. 0030) matching a coefficient of thermal expansion of a syringe barrel (Fig. 3A, container 10) or lower than the coefficient of thermal expansion of the syringe barrel (10). The barrel (10) of Laurance is comprised of glass or a polymeric material (polypropylene and glass; para. 0038) and the stopper (30) is comprised of a blend of an elastomeric material (bromobutyl rubber; para. 0037) and an intermixed material (Beta-eucryptite or graphene; para. 0039). Since the barrel and stopper of Laurance comprise materials and blends of materials that are the same as the materials of the barrel and stopper of the claimed invention, a skilled artisan would have concluded that the coefficient of thermal expansion of each of the barrel and stopper of Laurance has the same characteristics as the claimed invention, namely, the stopper has a coefficient of thermal expansion matching a coefficient of thermal expansion of the syringe barrel or lower than the coefficient of thermal expansion of the syringe barrel.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Prasad such that the blended material of the stopper has a coefficient of thermal expansion matching a coefficient of thermal expansion of the syringe barrel or lower than the coefficient of thermal expansion of the syringe barrel as taught by Laurance in order to prevent possible failure of container closure integrity and preserving the contents of the syringe when stored at lower temperatures (Laurance: para. 0030).
Regarding claim 13, Prasad in view of Laurance discloses apparatus above.
Prasad does not expressly disclose the intermixed material has a negative coefficient of thermal expansion.
Laurance teaches an intermixed material (material is blended with elastomeric material; para. 0030) that has a negative coefficient of thermal expansion (the material has a negative thermal expansion coefficient; para. 0030).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the intermixed material of Prasad such that the intermixed material has a negative coefficient of thermal expansion as taught by Laurance in order to prevent possible failure of container closure integrity and preserving the contents of the syringe when stored at lower temperatures (Laurance: para. 0030).
Regarding claim 14, Prasad in view of Laurance discloses the apparatus above.
Prasad does not expressly disclose the intermixed material comprises graphene, a hexagonal boron nitride (coronene) compound, ScF3 compound, ZrW208, or beta- eucryptite and Ca2RuO4.
Laurance teaches the intermixed material (para. 0030) comprises graphene, a hexagonal boron nitride (coronene) compound, ScF3 compound, ZrW208, or beta- eucryptite and Ca2RuO4 (Beta-eucryptite or graphene; para. 0039).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the intermixed material of Prasad such that the intermixed material comprises graphene, a hexagonal boron nitride (coronene) compound, ScF3 compound, ZrW208, or beta- eucryptite and Ca2RuO4 as taught by Laurance in order to allow the intermixed material to have a negative coefficient of thermal expansion (Laurance: para. 0039).
Regarding claim 15, Prasad in view of Laurance discloses the apparatus above.
Prasad does not expressly disclose the stopper comprises an inert coating applied to at least a portion of an outer surface thereof.
Laurance teaches a stopper (Laurance: 30) comprising an inert coating (closure 30 is coated with an inert film; para. 0045) applied to at least a portion of an outer surface thereof (30 surface is coated with film; para. 0045).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the stopper such that it comprises an inert coating applied to at least a portion of an outer surface thereof as taught by Laurance in order to prevent contact of the blended material with the medicament; para. 0045).
Regarding claim 16, Prasad in view of Laurance discloses the apparatus above, wherein the syringe barrel (12) is composed of a glass substrate (barrel 12 is formed from glass; para. 0072) or a polymeric substrate (barrel 12 is formed from polypropylene; para. 0072).
Regarding claim 17, Prasad in view of Laurance discloses the apparatus above, wherein the apparatus (10) is a prefilled syringe (para. 0075), with the container (12) comprising a syringe barrel (Fig. 2A, barrel 12 is a syringe barrel) and the sealing component (16) comprising a stopper (Fig. 2A, stopper 16 is a stopper) affixed to a distal end (Fig. 2A, distal end 60) of a plunger rod (Fig. 2A, plunger rod 14).
Regarding claim 18, Prasad in view of Laurance discloses the apparatus above, further comprising a distal end cap (Prasad: syringe assembly 10 may include a cap; para. 0075) positioned over a nozzle (Fig. 2A, luer tip 42) at the distal end (32) of the barrel chamber (36).
Prasad does not expressly disclose the distal end cap comprises a blended material including a polymeric material and an intermixed material having a coefficient of thermal expansion lower than the polymeric material.
Laurance teaches a distal end cap (Laurance: Fig. 8B, vial stopper 81) comprises a blended material (Fig. 8B, comprising elastomeric body 82 and material 84) including a polymeric material (elastomeric body 82 can comprise polyisoprene; para. 0037) and an intermixed material (material 84; para. 0030) having a coefficient of thermal expansion lower than the polymeric material (para. 0030).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the distal end cap of Prasad such that the distal end cap comprises a blended material including a polymeric material and an intermixed material having a coefficient of thermal expansion lower than the polymeric material as taught by Laurance in order to seal the syringe (para. 0033 and 0048) and prevent possible failure of container closure integrity and preserving the contents of the syringe when stored at lower temperatures (Laurance: para. 0030).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Prasad in view of Laurence, in further view of Mandal et al. (US Patent Publication No. 20220105000 A1), hereinafter Mandal.
Regarding claim 7, Prasad in view of Laurance discloses the syringe above.
Prasad in view of Laurance does not expressly disclose the inert coating comprises a parylene coating.
Mandal teaches an inert coating (Mandal: parylene resin; para. 0033) comprising a parylene coating (para. 0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the inert coating of Prasad in view of Laurance such that the inert coating comprises a parylene coating as taught by Mandal in order for the stopper to have anti-adhesive properties (Mandal: para. 0033).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Prasad in view of Laurance, in further view of Dix et al. (US Patent Publication No. 20200155760 A1), hereinafter Dix, and Bauss (US Patent Publication No. 20150090625 A1).
Regarding claim 19, Prasad discloses a method of assembling a prefilled syringe (Prasad: Fig. 1, syringe assembly 10 is pre-filled; para. 0075), the method comprising: providing a syringe barrel (Fig. 1, syringe barrel 12) comprising a proximal end (Fig. 2A, proximal end 34) and a distal end (Fig. 2A, distal end 32) and defining a chamber (Fig. 2A, chamber 36), the syringe barrel (12) having an opening (Fig. 2A, end 34 is shown having an opening) at the proximal end (34); providing a plunger assembly (Fig. 2A, comprising plunger rod 14 and stopper 16) insertable into the opening (opening at 34), the plunger assembly (14 and 16) including: a plunger rod (Fig. 2A, plunger rod 14) comprising an elongated body (Fig. 2A, plunger rod body 64) and extending between a proximal end (34) and a distal end (32); and a stopper (Fig. 2A, stopper 16) attached to the distal end (Fig. 2A, first end 60) of plunger rod (14) and positioned within the barrel chamber (36); wherein the stopper (16) comprises a blended material (stopper 16 comprises thermoplastic elastomer with added filler; para. 0100) including an elastomeric material (thermoplastic elastomer; para. 0100) and an intermixed material (filler; para. 0100) having a coefficient of thermal expansion that is lower than a coefficient of thermal expansion the elastomeric material (filler has low thermal expansion coefficient compared to the high thermal expansion coefficient of the thermoplastic elastomer; para. 0100).
Prasad does not expressly disclose the intermixed material has a negative coefficient of thermal expansion, wherein the intermixed material of the stopper has a coefficient of thermal expansion matching a coefficient of thermal expansion of the syringe barrel or lower than the coefficient of thermal expansion of the syringe barrel.
Laurance teaches an intermixed material (material is blended with elastomeric material; para. 0030) that has a negative coefficient of thermal expansion (the material has a negative thermal expansion coefficient; para. 0030); wherein the intermixed material (Laurance: Fig. 3A, container closure 11 comprises a blended material; para. 0030) of a stopper (Fig. 3A, container closure 30) has a coefficient of thermal expansion (para. 0030) matching a coefficient of thermal expansion of a syringe barrel (Fig. 3A, container 10) or lower than the coefficient of thermal expansion of the syringe barrel (10). The barrel (10) of Laurance is comprised of glass or a polymeric material (polypropylene and glass; para. 0038) and the stopper (30) is comprised of a blend of an elastomeric material (bromobutyl rubber; para. 0037) and an intermixed material (Beta-eucryptite or graphene; para. 0039). Since the barrel and stopper of Laurance comprise materials and blends of materials that are the same as the materials of the barrel and stopper of the claimed invention, a skilled artisan would have concluded that the coefficient of thermal expansion of each the barrel and stopper of Laurance would have the same characteristics, namely, the stopper has a coefficient of thermal expansion matching a coefficient of thermal expansion of the syringe barrel or lower than the coefficient of thermal expansion of the syringe barrel.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Prasad such that the intermixed material has a negative coefficient of thermal expansion; wherein the intermixed material of the stopper has a coefficient of thermal expansion matching a coefficient of thermal expansion of the syringe barrel or lower than the coefficient of thermal expansion of the syringe barrel as taught by Laurance in order to prevent possible failure of container closure integrity and preserving the contents of the syringe when stored at lower temperatures (Laurance: para. 0030).
Prasad in view of Laurance does not expressly disclose a vent tube stoppering tool that holds the plunger assembly therein; and inserting the plunger assembly into the syringe barrel using the vent tube stoppering tool.
Dix teaches a vent tube stoppering tool (Dix: vent tube stoppered; para. 0023) that holds the plunger assembly (Fig. 5A, stopper 156) therein (para. 0023); and inserting the plunger assembly (156) into the syringe barrel (Fig. 5A, body 102) using the vent tube stoppering tool (para. 0023).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Prasad in view of Laurance such that a vent tube stoppering tool that holds the plunger assembly therein; and inserting the plunger assembly into the syringe barrel using the vent tube stoppering tool as taught by Dix in order to place the stopper as close to the medicament as possible (Dix: para. 0066) without the tools touching and contaminating the contents of the syringe (para. 0023).
Prasad in view of Laurance and Dix does not expressly disclose the vent tube stoppering tool heated to a temperature that causes the stopper to contract.
Bauss teaches heating a stopper (Bauss: Fig. 8B, capsule 10) to a temperature that causes the stopper to contract (closure capsule is heated, thus contracting; para. 0015).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Prasad in view of Laurance and Dix such that the vent tube stoppering tool is heated to a temperature that causes the stopper to contract as taught by Bauss in order to create a closure that has a very snug fit (Bauss: para. 0015).
Regarding claim 20, Prasad in view of Laurance, Dix, and Bauss discloses the method above.
Prasad in view of Laurance and Bauss does not expressly disclose filling the barrel with a liquid solution prior to inserting of the plunger assembly.
Dix teaches filling a barrel (Dix: 102) with a liquid solution (Fig. 5A, drug substance 202) prior to inserting of a plunger assembly (Fig. 4, step 306, drug substance is pre-filled in syringe prior to stoppering, step 308).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Prasad in view of Laurance and Bauss to include filling the barrel with a liquid solution prior to inserting of the plunger assembly as taught by Dix in order to allow the stopper to be placed as close to the medicament as possible (Dix: para. 0066).
Response to Arguments
Applicant's arguments filed 22 April 2026 have been fully considered but they are not persuasive.
Applicant argues that Laurance fails to disclose the coefficient of thermal expansion would be with regards to the container and the container closure, and, therefore, it would not have been obvious to select specific materials to arrive to the amended claim language of the independent claims.
Laurance specifically states materials for the blended material as well as the container. Materials such as glass (Laurance: polypropylene and glass; para. 0038), Beta-eucryptite or graphene (para. 0039), and bromobutyl rubber (para. 0037) all have specific coefficients of thermal expansion. The coefficient of thermal expansion of both the bromobutyl rubber and beta-eucrptite/graphene are known to have lower coefficient of thermal expansion than that of glass. Furthermore, the advantages taught in Laurance, i.e., preventing closure integrity failure and preserving contents at lower temperatures, are made possible by using the materials disclosed in Laurance, such as glass, having a higher coefficient of thermal expansion compared to the blended material of the stopper.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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