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 .
Response to Amendment
Claims 1-8 remain pending with claims 7-8 withdrawn.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 and 5-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matsutani et al. (US 20150367076, henceforth Matsutani, previously made of record).
Regarding claim 1, Matsutani discloses a gasket (gasket 13, fig. 2) comprising: a gasket body (main body 14, fig. 2) consisting of a monolithic structure (see fig. 2, main body is a monolithic structure which is a unitarily formed piece) including a solution contact portion (see the front portion called out as 19 shown in fig. 2), a slide contact portion (see the side portion called out as 17 having two projections 17A and 17B in fig. 2), and a small diameter portion (this is the indented portion in the middle of projections 17A and 17B as shown in fig. 2), wherein the solution contact portion, the slide contact portion, and the small diameter portion are formed continuously (see fig. 2, all of the portions are contiguously formed and integral with one another and are thus formed continuously) and the small diameter portion has a smaller diameter than the slide contact portion (see fig. 2, the outer diameter of the called out small diameter portion is less than the outer diameter of the slide contact portion at projections 17 as shown); and a polytetrafluoroethylene (PTFE) film (lamination film 15 which can be PTFE as in [0050], fig. 2) attached to a solution contact surface of the solution contact portion of the gasket body (see fig. 2, film 15 is attached to the front surface which includes the pointed tip of front portion 19 as shown where the front surface is the solution contact surface), wherein a circumferential end portion of the PTFE film (the portion of film 15 between projection 17a and rear portion 20 as shown in fig. 2) is curved on the slide contact portion of the gasket body (see fig. 2, the portion of film 15 between projection 17a and rear portion 20 as shown curves onto second projection 17B which is a portion of the slide contact portion of the gasket body as claimed), and a circumferential end surface of the PTFE film (the end surface of film 15 which is closest to rear portion 20 as shown in annotated fig. 2) is buried in the slide contact portion of the gasket body (see annotated fig. 2, the inner edge of the circumferential end surface is buried inside of the sidewall of side portion 17) so as not to be exposed outside (see fig. 2) except for an outer edge of the circumferential end surface (see annotated fig. 2, the called out outer edge of the circumferential end surface is not buried as claimed) and so that an exposed surface of the PTFE film (this is the outer edge as called out in the provided annotated fig. 2) is colinear with a slide contact surface of the slide contact portion (see fig. 2, since the exposed edge flows directly back into the side wall of side portion 17 as shown in fig. 2 without a gap, it is colinear), each of the exposed surface of the PTFE film and the slide contact surface of the slide contact portion is configured to be in contact with a syringe barrel (the slide contract portion is in contact with a syringe barrel when it is assembled in a syringe as shown in fig. 4 as is the exposed outer surface of film 15, with the slide contact portion being in contact with barrel 11 via film 15 as an intervening structure), and the slide contact surface of the slide contact portion leads to the small diameter portion (see fig. 2; since the two surfaces are continuous with one another, they are considered to lead to one another as claimed).
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Annotated fig. 2 from Matsutani
Regarding claim 3, Matsutani discloses the gasket of claim 1 wherein the circumferential end surface of the PTFE film is made sealed by the gasket body (see annotated fig. 2, the inner edge surface as called out is sealed by the gasket body 14).
Regarding claim 5, Matsutani discloses the gasket of claim 1 wherein the gasket body is made of silicone rubber (see [0042], silicone rubber can be used) provided with slidability ([0004]).
Regarding claim 2, Matsutani discloses a gasket (gasket 13, fig. 2) comprising: a gasket body (main body 14, fig. 2) consisting of a monolithic structure (see fig. 2, main body is a monolithic structure which is a unitarily formed piece) including a solution contact portion (see the front portion called out as 19 shown in fig. 2), a first slide contact portion (first annular projection 17A, fig. 2) continuing to the solution contact portion (see fig. 2, the two portions are contiguous to one another and thus continue to one another), a small diameter portion (the portion between first annular projection 17A and second annular projection 17B as shown in fig. 2) continuing to the first slide contact portion (see fig. 2, the two portions are contiguous to one another and thus continue to one another), and a second slide contact portion (second annular projection 17B, fig. 2) continuing to the small diameter portion (see fig. 2, the two portions are contiguous to one another and thus continue to one another), the first and second slide contact portions each having a protrusive cross section (projections 17A and 17B each have a protrusive cross section relative to the small diameter portion between them as shown in fig. 2) and a larger diameter than the small diameter portion (see fig. 2; where the diameter is measured horizontally in the provided orientation, protrusions 17A and 17B have a larger diameter than the small diameter portion between them); and a polytetrafluoroethylene (PTFE) film (lamination film 15 which can be PTFE as in [0050], fig. 2) attached to a solution contact surface of the solution contact portion of the gasket body (see fig. 2, film 15 is attached to the front surface which includes the pointed tip of front portion 19 as shown where the front surface is the solution contact surface), wherein a circumferential end portion of the PTFE film (the portion of film 15 between the front portion and the rear portion as called out in annotated fig. 2) is curved from the solution contact portion of the gasket body so as to extend across an apex of the first slide contact portion (see fig. 2, the called out circumferential end portion curves onto curves across first projection 17A entirely, thus including its apex), while a circumferential end surface of the PTFE film (this surface is the radial interior surface of the circumferential end portion as called out above) is in surface contact with a lateral surface of the small diameter portion (see fig. 2, the called out circumferential end surface is in direct surface contact with radial exterior of the small diameter portion where it covers it).
Regarding claim 6, Matsutani discloses a syringe (prefilled syringe 10, fig. 1) comprising: the gasket recited in claim 1 (see the rejection of claim 1); a medical solution (liquid drug as in [0004], also shown as W in fig. 4A); a syringe barrel (syringe barrel 11, fig. 1); and a plunger rod (plunger rod 12, fig. 1).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsutani et al. (US 20150367076, henceforth Matsutani) as applied to claim 1 above, and further in view of Yotsutsuji (US 20140207075, henceforth Yotsutsuji, previously made of record).
Regarding claim 4, Matsutani 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. 2 above). Matsutani also discusses that the PTFE film can have problems during manufacturing with tearing ([0009]).
Matsutani 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 Matsutani 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 a skilled artisan would reasonable 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 filed 12/23/2025 have been fully considered but they are not persuasive.
Applicant has argued that the PTFE film 15 of Matsutani is not colinear with the slide contact surface as claimed since they do not lie in the same straight line. Merriam Webster’s full definition of colinear (alternatively spelled/defined as collinear) is “lying on or passing through the same straight line”. The end of the PTFE film 15 of Matsutani lies on the straight line formed by the end of the slide contact surface closest to the rear portion of the gasket body as shown in fig. 2 of Matsutani where the PTFE film is shown having no gaps at its junction with the straight line formed by the surface of gasket body (see also below calling out the straight line with a dashed line showing how the PTFE film is laying on this line).
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An additional definition of colinear from Merriam-Webster includes “having corresponding parts arranged in the same linear order”, which also appears to be met by Matsutani as the corresponding parts of the straight line of the gasket body (provided with a dashed line above) is in linear order with the PTFE film where they intersect at a smooth junction without gaps.
Applicant has also argued that Matsutani does not disclose that the slide contact portion is configured to be in contact with a barrel of a syringe as claimed. Examiner respectfully disagrees, since the slide contact portion of Matsutani is in contact with the barrel 11 as shown in fig. 4 via the PTFE film 15 and the claim does not require direct surface contact of the slide contact portion with the barrel, and thus intervening structures are not prohibited.
Applicant has additionally argued regarding claim 2 that Matsutani’s film covering all of the slide contact portions is different and distinguishable from Applicant’s subject matter; the claim does not require that the film cannot cover both of the first and second slide contact portions, and thus this does not prevent Matsutani from reading on claim 2 and its dependents.
Thus, Examiner respectfully finds Applicant’s arguments unpersuasive and rejects the claims as indicated above.
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 mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL J MARRISON/ Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783