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 and 2 have been amended and claim 9 has been added. Claims 1-9 remain pending with claims 7-8 withdrawn.
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.
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, 3-4, 6, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maeda et al. (US 20140062036, henceforth Maeda).
Regarding claim 1, Maeda discloses a gasket (assembly of fig. 3C) comprising: a gasket body (see gasket body 1 in annotated fig. 3C) consisting of a monolithic structure (see fig. 3C, the body is monolithic) including a solution contact portion (see section 2 in annotated fig. 3C), a slide contact portion (see section 3 in annotated fig. 3C), and a small diameter portion (see portion 4 in annotated fig. 3C), wherein the solution contact portion, the slide contact portion, and the small diameter portion are formed continuously (see fig. 3C), and the small diameter portion has a smaller diameter than the slide contact portion (see fig. 3C); and a polytetrafluoroethylene (PTFE) film (see the film 5 of fig. 3C, which is PTFE as in [0016]) attached to a solution contact surface of the solution contact portion of the gasket body (see surface 6 in annotated fig. 3C), wherein a circumferential end portion of the film (see second annotated fig. 3C providing a more exploded view of the circumferential end portion of the film as claimed; the circumferential end portion is portion 7) is curved on the slide contact portion of the gasket body (see fig. 3C), and a circumferential end surface of the film (see surface 8 in annotated fig. 3C) is buried in the slide contact portion of the gasket body so as not to be exposed outside except for an outer edge of the circumferential end surface (see annotated fig. 3C, the shown arrangement is the same as the claimed arrangement, especially where edge 9 remains exposed as claimed) and so that an exposed surface of the film (see surface 10 in annotated fig. 3C) is colinear with a slide contact surface of the slide contact portion (see fig. 3C, the called out surface 10 of the film and the exterior most surface of the gasket body, surface 11, are colinear), and the exposed surface and the slide contact surface form a shared plane (see fig. 3C, the called out surface of the film 10 and the slide contact surface 11 fall circumferentially 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 ([0020]), and the slide contact surface of the slide contact portion leads to the small diameter portion (see fig. 3C).
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First annotated fig. 3C of Maeda calling out claimed structures
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Second annotated fig. 3C of Maeda calling out the claimed structures of the circumferential end portion of the film
Regarding claim 3, Maeda discloses the gasket of claim 1 wherein the circumferential end surface of the PTFE film is made sealed by the gasket body (see fig. 3C, the circumferential end surface is made sealed by the shaping of the gasket body where the circumferential end surface is covered and buried into the wall of the gasket body).
Regarding claim 4, Maeda discloses the gasket of claim 1 wherein the circumferential end portion of the PTFE film attached to the solution contact surface of the gasket body has an extension ratio of less than or equal to 10% (see [0012] and [0025], the expansion ratio which is an extension ratio is preferably 0.1-8.0% which is less than 10% as claimed).
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.
Regarding claim 9, Maeda discloses the gasket of claim 1 wherein, prior to application of force, the circumferential end surface of the PTFE film is buried in the slide contact portion of the gasket body so as not to be exposed outside (see Maeda figs. 7 and 8, the film is buried in the side as claimed without further application of force needed).
Regarding claim 6, Maeda discloses a syringe (syringe of [0012]) comprising: the gasket recited in claim 1 (see rejection of claim 1 above); a medical solution (chemical liquid as in [0001] and [0002]); a syringe barrel (syringe barrel of [0012]); and a plunger rod (plunger rod of [0023], [0045], and [0062]).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thijs et al. (US 20190307964, henceforth Thijs) in view of Matsutani et al. (US 20150367076, henceforth Matsutani, previously made of record).
Regarding claim 2, Thijs discloses a gasket (assembly of fig. 7) comprising: a gasket body (plunger 3, fig. 7) consisting of a monolithic structure (see fig. 7) including a solution contact portion (tip section 14 which is distal to the apex of sealing bead 15, fig. 7, where the distal direction extends from sealing bead 17 towards sealing bead 15), a first slide contact portion (sealing bead 15, fig. 7) continuing to the solution contact portion (see fig. 7), a small diameter portion (the portion of lateral surface 19 which is not curved and extends between sealing bead 15 and sealing bead 16, figs. 6 and 7) continuing to the first slide contact portion (see figs. 6 and 7), and a second slide contact portion (sealing bead 16, fig. 7) continuing to the small diameter portion (see figs. 6 and 7), the first and second slide contact portions each having a protrusive cross section (see fig. 7, sealing beads 15 and 17 protrude from lateral surface 19) and a larger diameter than the small diameter portion (see fig. 7, sealing beads 15 and 17 protrude from lateral surface 19); and a polytetrafluoroethylene (PTFE) film (cover layer 18, fig. 7, which is PTFE as in [0027]) attached to a solution contact surface of the solution contact portion of the gasket body (see fig. 7, where the solution contact surface is the distal most end surface of tip section 14), wherein the small diameter portion is located between the first slide contact portion and the second slide contact portion (see figs. 6 and 7), a circumferential end portion of the film (see the proximal most end of cover layer 18, fig. 8, where the proximal direction is antiparallel to the distal direction) is curved from the solution contact portion of the gasket body (see fig. 7) so as to extend across an apex of the first slide contact portion (see fig. 8). Thijs additionally discloses that the cover layer can be arranged in a variety of ways, including having a circumferential end surface ending more distally than the chosen embodiment (see figs. 2-5), or being sprayed on and not having a circumferential end surface (see fig. 9).
Thijs does not disclose the gasket where a circumferential end surface of the film is in direct surface contact with a lateral surface of the small diameter portion, and the circumferential end surface is a proximal most end of the film. Matsutani teaches a gasket (assembly of fig. 2) having a film (lamination film 15, fig. 2) arranged to extend over an entire protrusion (see fig. 2, film 15 extends over circumferential projection 17B) such that a circumferential end surface of the film (see the proximal most end surface of film 15 in fig. 2) extends to a small-diameter portion of the gasket to be in direct surface contact with a lateral surface of the small diameter portion (see fig. 2, the circumferential end surface is buried in a small diameter portion proximal to projection 17B) where the circumferential end surface is a proximal most end of the film (see fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have lengthened the cover layer of Thijs to extend such that the circumferential end surface of the cover layer was in direct surface contact with a lateral surface of the small diameter portion as in Matsutani as Matsutani teaches such a film arrangement to provide superior sealing and slidability characteristics (see [0006] and [0007]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maeda et al. (US 20140062036, henceforth Maeda) in view of Nakano et al. (US 20140339777, henceforth Nakano, previously made of record).
Regarding claim 5, Maeda discloses the gasket of claim 1 wherein the gasket body is made of rubber (see [0043] and [0044]) and is provided with slidability (see Abstract). Maeda additionally discloses that the gasket body material can be any suitable elastic material including various rubber blends ([0044]).
Maeda 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 Maeda 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 Maeda discloses that its gasket body is similarly elastomeric ([0019]) and rubber ([0044]).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
