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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/15/2026 has been entered.
Response to Amendment
Claims 1 and 2 have been amended. Claims 1-8 remain pending with claims 7-8 withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 is objected to where it has a typographical error where it recites “and the exposed surface and the slide contact surface form a same plane”. This appears to create an issue with antecedent basis as the claim does not previously have a plane established, and thus there cannot be “a same plane” to a non-established plane. The objection could be overcome by stating that the surfaces form a shared plane, or that the exposed surface forms a first plane and the slide contact surface forms a second plane which is the same plane as the first plane, or an alternative equivalent wording which further demonstrates the coplanar nature of the surfaces.
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3 and 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voytilla (US 20180344940, henceforth Voytilla, previously made of record in the IDS filed 11/30/2021) in view of Nakano et al. (US 20140339777, henceforth Nakano).
Regarding claim 1, Voytilla discloses a gasket (plunger 10, fig. 2B) comprising: a gasket body (body 12, fig. 2B) consisting of a monolithic structure (see fig. 2A, the body is monolithic) including a solution contact portion (the portion of rib 19 distal point of contact T, fig. 2C, where the distal direction is the direction pointing from rib 17 to rib 19 in fig. 2A), a slide contact portion (the portion of rib 19 proximal to point of contact T, figs. 2A and 2C, where the proximal direction is opposite the distal direction), and a small diameter portion (radial concave portion 18’, fig. 2A), wherein the solution contact portion, the slide contact portion, and the small diameter portion are formed continuously (see fig. 2A), and the small diameter portion has a smaller diameter than the slide contact portion (see fig. 2A); and a film (film 20, fig. 2A) attached to a solution contact surface of the solution contact portion of the gasket body (see fig. 2A, the solution contact surface is the surface spanned by diameter D2), wherein a circumferential end portion of the film (the portion of film 20 located on overhanging portion 21, fig. 2C) is curved on the slide contact portion of the gasket body (see annotated fig. 2C), and a circumferential end surface of the film (see annotated fig. 2C) is buried in the slide contact portion of the gasket body so as not to be exposed outside (see fig. 2C) except for an outer edge of the circumferential end surface (see annotated fig. 2C) and so that an exposed surface of the film (the surface of film 20 provided at point of contact T, fig. 2C) is colinear with a slide contact surface of the slide contact portion (see fig. 2C, film 20 and body 12 both contact interior wall 30 as they are colinear), and the exposed surface and the slide contact surface form a same plane (see fig. 2C, film 20 and body 12 both contact interior wall 30 where they fall along the same plane), each of the exposed surface of the film and the slide contact surface of the slide contact portion is configured to be in direct contact with a syringe barrel ([0034]), and the slide contact surface of the slide contact portion leads to the small diameter portion (see fig. 2A). Voytilla additionally discloses that its film is to provide chemical inertness and is a fluoropolymer material ([0004]).
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Annotated fig. 2C from Voytilla
Voytilla does not disclose that the film is a PTFE film. Nakano teaches using PTFE for films or gaskets ([0005]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the film of Voytilla out of PTFE as in Nakano for providing high sliding properties in the syringe and providing high chemical stability with inertness ([0005]), especially since the film of Voytilla is already meant to provide chemical inertness.
Regarding claim 3, Voytilla as modified discloses the gasket of claim 1 wherein the circumferential end surface of the PTFE film is made sealed by the gasket body (see fig. 2C, the circumferential end surface is made sealed by the shaping of the gasket body where it presses against inner wall 30 and is thus made sealed as claimed).
Regarding claim 5, Voytilla as modified discloses the gasket of claim 1 wherein the gasket body is elastomeric ([0008]) and made of a molded polymer material ([0030]) and is provided with slidability (in the modified device, slidability is provided from the PTFE film of Nakano, see Nakano [0005]). Voytilla additionally discloses that polymer materials conventionally used to make gaskets include rubbers ([0004]).
Voytilla as modified does not explicitly disclose that the gasket body is made of silicone rubber. Nakano teaches that gaskets can be made of any elastomeric material ([0024]) such as silicone rubber ([0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the gasket body of Voytilla from silicone rubber material as Nakano teaches silicone rubber to be an acceptable material yielding the desired elastomeric characteristics for syringe gaskets ([0024]), especially since Voytilla discloses that its gasket body is similarly elastomeric ([0008]) and polymeric ([0030]).
Regarding claim 2, Voytilla discloses a gasket (plunger 10, fig. 2B) comprising: a gasket body (body 12, fig. 2B) consisting of a monolithic structure (see fig. 2A, the body is monolithic) including a solution contact portion (the portion of rib 19 distal point of contact T, fig. 2C, where the distal direction is the direction pointing from rib 17 to rib 19 in fig. 2A), a first slide contact portion (the portion of rib 19 proximal to point of contact T, figs. 2A and 2C, where the proximal direction is opposite the distal direction) continuing to the solution contact portion (see figs. 2A and 2C), a small diameter portion (radial concave portion 18’, fig. 2A) continuing to the first slide contact portion (see figs. 2A and 2C), and a second slide contact portion (rib 18, fig. 2A) continuing to the small diameter portion (see fig. 2A), the first and second slide contact portions each having a protrusive cross section (see fig. 2A) and a larger diameter than the small diameter portion (see fig. 2A); and a film (film 20, fig. 2A) attached to a solution contact surface of the solution contact portion of the gasket body (see fig. 2A, the solution contact surface is the surface spanned by diameter D2), wherein the small diameter portion is located between the first slide contact portion and the second slide contact portion (see fig. 2A), a circumferential end portion of the film (the portion of film 20 located on overhanging portion 21, fig. 2C) is curved from the solution contact portion of the gasket body (see fig. 2C) so as to extend across an apex of the first slide contact portion (see annotated fig. 2C, the apex of the first slide contact portion is the dashed line which differentiates the slide contact portion with the solution contact portion, and it is an apex as it is the end point of a curve on the slide contact portion which film 20 covers), while a circumferential end surface of the film is in surface contact with a lateral surface of the small diameter portion (see annotated fig. 2C, the called out circumferential end surface is in surface contact with a lateral exterior most surface of radial concave portion 18’ via rib 19), and the circumferential end surface is a proximal most end of the film (see annotated fig. 2C). Voytilla additionally discloses that its film is to provide chemical inertness and is a fluoropolymer material ([0004]).
Voytilla does not disclose that the film is a PTFE film. Nakano teaches using PTFE for films or gaskets ([0005]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the film of Voytilla out of PTFE as in Nakano for providing high sliding properties in the syringe and providing high chemical stability with inertness ([0005]), especially since the film of Voytilla is already meant to provide chemical inertness.
Regarding claim 6, Voytilla as modified discloses a syringe (syringe assembly 100, fig. 5A) comprising: the gasket recited in claim 1 (see rejection of claim 1 above); a medical solution (liquid pharmaceutical solution of [0037]); a syringe barrel (barrel 120, fig. 5A); and a plunger rod (plunger rod 110, fig. 5A).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voytilla (US 20180344940, henceforth Voytilla) in view of Nakano et al. (US 20140339777, henceforth Nakano) as applied to claim 1 above, and further in view of Yotsutsuji (US 20140207075, henceforth Yotsutsuji, previously made of record).
Regarding claim 4, Voytilla as modified discloses the gasket of claim 1 wherein the circumferential end portion of the PTFE film is attached to the solution contact surface of the gasket body (see annotated fig. 2C). Voytilla also discusses that formation of the film can have problems during manufacturing with tearing ([0005]).
Voytilla as modified does not disclose the gasket wherein the circumferential end portion of the PTFE film is attached to the solution contact surface of the gasket body has an extension ratio of less than or equal to 10%. Yotsutsuji teaches that during manufacturing, PTFE film is stretched (see [0019] and [0059]) and that poor elongation and stretching can cause tearing ([0059]-[0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the amount of stretching required on the PTFE film of Voytilla as modified during manufacturing such as to yield the best results and minimize the chances of tearing as Yotsutsuji teaches that proper manufacturing including limiting of stretching of the PTFE film can prevent manufacturing failures and can better create the desired properties of the gasket (see Yotsutsuji [0059]-[0061]). While this is not an explicit teaching of the claimed extension ratio, since the claimed extension ratio is a ratio of the increase in area between the pre-stretched and post-stretched film at the slide contact portion, this is considered to be a teaching that the extension ratio as claimed is a result effective variable which changes depending on the amount of stretch present in manufacturing for a small area, and since one of ordinary skill in the art would reasonably minimize and optimize this variable such as to create the desired film characteristics and such as to prevent manufacturing failures from torn laminated film sections, it is further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the extension ratio be less than or equal to 10% as claimed if this is a level at which manufacturing failures become more prevalent or if the film characteristics become undesirable.
Further, the applicant is advised that 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. See MPEP §2113.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 2 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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