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 .
Information Disclosure Statement
The information disclosure statement(s) have been considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 2/25/2026. As directed by the amendment: claims 1, 5, and 8 have been amended. Thus, claims 1 and 5-8 are presently pending in this application.
Response to Arguments
Applicant’s arguments pertaining to the orientation of the claimed groove during the widened and narrowed positions of the claimed engaging claws with respect to claims 1, 5, and 8 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.
Regarding applicant’s argument regarding the corresponding dependent claims, applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable. As examiner notes above, and presents below, the new grounds of rejection render the independent claims unpatentable under 35 U.S.C. 103, and for at least this reason the proceeding dependent claims are likewise rejected.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5, and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP 2332602 A1, henceforth written as McLaren.
Regarding claim 1, McLaren discloses:
An injection system comprising:
(invention of fig 1-2)
a gasket having
(piston 2; fig 1-2)
a plurality of engaging claws;
(lugs 8; fig 1-2)
a ram to be engaged with the gasket from a rear-end surface of the gasket;
(coupling trunion 6; fig 1)
a cylinder into which the gasket is to be inserted;
(container body 1; fig 1); fig 1)
and an injection device configured to move the ram forward and injecting a chemical solution in the cylinder,
(piston rod 5; fig 1)
wherein each of the engaging claws is configured to be displaced between a widened position and a narrowed position,
(fig 1a-c illustrate the lugs 8 being displaced between a widened position in fig 1a and a narrowed position in fig 1b)
and has an inner surface that defines a space, into which the ram is inserted,
(see examiner's annotation of McLaren's fig 1, below, denoting the claimed inner surface and claimed space of lug 8)
an outer surface of each of the engaging claws is recessed so that a groove which serves as a starting point of deformation of the engaging claws is formed on a radially outermost surface of the gasket,
(see examiner's annotation of McLaren's fig 1, below, denoting the claimed groove as the portion of piston 2 between lugs 8 and the flanges of piston 2)
the each of the engaging claws has a portion located between the space and a bottom of the groove in a radial direction of the gasket,
(see examiner's annotation of McLaren's fig 1, below, denoting the claimed portion as a portion of lug 2 which joins to piston 2)
the each of the engaging claws includes a ridge protruding in a direction away from a perpendicular line passing through a center of the space, an enlarged diameter portion for receiving the ridge is formed in a rear end portion of the cylinder,
(see examiner's annotation of McLaren's fig 1, below, denoting the claimed ridge as a portion of lug 8 which is received in the recesses 9 which form an enlarged diameter portion of cylinder 1)
the engaging claws are in the widened position while each ridge is received in the enlarged diameter portion prior to the ram engaging the rear-end surface of the gasket and the groove is in an initial narrow configuration where the groove is not deformed, and
(fig 1a illustrates lugs 8 in a widened position wherein the grooves in an initial, undeformed, and relatively narrow configuration)
the engaging claws are in the narrowed position when a front end face of the ram abuts the gasket in an insertion direction of the ram and the groove has been deformed so as to widen in the insertion direction relative to the groove's initial narrow configuration.
(fig 1b-1c illustrates lugs 8 in a narrowed position when a front end of trunnion 6 abuts piston 6 to displace lugs 8 in recesses 9 such that the claimed grooves are deformed so as to widen in an insertion direction relative to the widened position illustrated fig 1a)
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Regarding claim 5, McLaren discloses:
A gasket comprising:
(piston 2; fig 1-2)
a rear-end surface from which a ram is to be engaged with the gasket: and
(coupling trunnion 6 engages a rear surface of piston 2; fig 1)
a plurality of engaging claws,
(lugs 8; fig 1-2)
wherein each of the engaging claws is configured to be displaced between a widened position and a narrowed position,
(fig 1a-c illustrate the lugs 8 being displaced between a widened position in fig 1a and a narrowed position in fig 1b)
and has an inner surface that defines a space, into which the ram is inserted,
(see examiner's annotation of McLaren's fig 1, above, denoting the claimed inner surface and claimed space of lug 8)
an outer surface of each of the engaging claws is recessed so that a groove which serves as a starting point of deformation of the engaging claws is formed on a radially outermost surface of the gasket,
(see examiner's annotation of McLaren's fig 1, above, denoting the claimed groove as the portion of piston 2 between lugs 8 and the flanges of piston 2)
the each of the engaging claws has a portion located between the space and a bottom of the groove in a radial direction of the gasket,
(see examiner's annotation of McLaren's fig 1, below, denoting the claimed portion as a portion of lug 2 which joins to piston 2)
the each of the engaging claws includes a ridge protruding in a direction away from a perpendicular line passing through a center of the space, an enlarged diameter portion for receiving the ridge is formed in a rear end portion of the cylinder,
(see examiner's annotation of McLaren's fig 1, above, denoting the claimed ridge as a portion of lug 2 which is received in the recesses 9 which form an enlarged diameter portion of cylinder 1)
the engaging claws are in the widened position while each ridge is received in the enlarged diameter portion prior to the ram engaging the rear-end surface of the gasket and the groove is in an initial narrow configuration where the groove is not deformed, and
(fig 1a illustrates lugs 8 in a widened position wherein the grooves in an initial, undeformed, and relatively narrow configuration)
the engaging claws are in the narrowed position when a front end face of the ram abuts the gasket in an insertion direction of the ram and the groove has been deformed so as to widen in the insertion direction relative to the groove's initial narrow configuration.
(fig 1b-1c illustrates lugs 8 in a narrowed position when a front end of trunnion 6 abuts piston 6 to displace lugs 8 in recesses 9 such that the claimed grooves are deformed so as to widen in an insertion direction relative to the widened position illustrated fig 1a)
Regarding claim 7, McLaren discloses:
A syringe having the gasket according to claim 5, the syringe comprising: a cylinder into which the gasket is to be inserted.
(abstract+paragraph 2+4; cylinder 1 of a syringe type container ; fig 1-2)
Regarding claim 8, McLaren discloses:
The injection system according to claim 1, wherein a distance between an inlet of the space and the bottom of the groove is longer than a distance between a bottom of the space and the bottom of the groove.
(see examiner's annotation of McLaren's fig 1, below, denoting the claimed inlet of the space as being parallel with the rear surface of lugs 8 and the claimed bottom of the space as being parallel with the rear surface of the rear flange; the defined groove spans from the rear surface of the rear flange toward a front surface of lugs 8, such that the inlet is at least further away from the bottom of the defined groove as compared to the bottom of the space by a distance correlating to the thickness of lug 8 from its front surface to its rear surface)
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Claim Rejections - 35 USC § 103
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over McLaren as presented in claims above and further in view of US 20050080380 A1, henceforth written as Hsieh.
Regarding Claim 6,
McLaren discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The injection system according to claim 1, wherein the gasket has [a shape]-
(paragraph 6; the container body may be right circular, right rectangular, or a right elliptical, therein ovular, interior space defining a longitudinal axis)
- and two engaging claws aligned in a direction
(lugs 8; fig 1-2)
However, McLaren is silent regarding:
wherein the gasket has four engaging claws, two aligned in a width direction and two aligned in a height direction
However, MPEP 2144.04(VI)(B) provides that an modification of the prior amounting to a mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Accordingly, duplicating the engaging claws aligned in a first direction of McLaren such that there are a secondary set of engaging claws aligned in another direction would similarly lack patentable significance as a new and unexpected result is not produced by such a modification.
Therefore it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to duplicate the engaging claws of McLaren such that there are two engaging claws aligned in a height and a weight directions respectively, as such a modification would not arrive at a new and unexpected result, see MPEP 2144.04(VI)(B), and would advantageously provide redundant means for mating the piston and ram which reduces risks associated with certain elements failing such as poor injection quality and under delivery of medicament, .
However, McLaren is silent regarding:
The injection system according to claim 1, wherein the gasket has a distal end portion having an oval cross-sectional shape, in which a length in a height direction of the cross-sectional shape is longer than a length in a width direction perpendicular to the height direction, and in the plurality of engaging claws, two engaging claws aligned in the height direction have the same shape and size, and two engaging claws aligned in the width direction have the same shape and size.
However, Hsieh teaches a syringe with gasket wherein:
wherein the gasket has a distal end portion (paragraph 19-20; fig 2-3; seal 30) having an oval cross-sectional shape in which a length in a height direction of the cross-sectional shape is longer than a length in a width direction perpendicular to the height direction (Hsieh: paragraph 19-20; fig 2; seal 30)
Hsieh in paragraph 20 additionally provides that its ovoid container shape, and consequential ovoid seal, disallows the medication container from rotating in response to the driving ram rotating to move forward/backward in the container.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply the oval cross-sectional shape teachings of Hsieh’s to the modified gasket of McLaren in order to arrive at the predictable result of a sealing plunger which is operable with an oval-shaped medication cylinder and consequently disallows rotation of the container relative to the rotation of a driving member. Preventing rotation of the gasket within the cylinder inhibits medication from slipping past the gasket and reducing the efficacy of whatever treatment is provided.
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 FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783