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 Arguments
Applicant’s arguments, filed 20 January 2026, with respect to the rejection(s) of claim(s) 1-7 under 35 USC 102 and 103 have been fully considered and are persuasive. Specifically, Applicant has amended the claims to overcome the previous rejection and further limits the claw and adapter. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tremblay (US 2018/0207062).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tremblay (US 2018/0207062).
Regarding claim 1, Tremblay discloses a plastic adapter (24, figures1 and 19A-D) attached the a pharmaceutical container (12) to which a plastic cap (18) is attached, the adapter covering the plastic cap from an outside thereof and locking the plastic cap (figures 19A-19B), the plastic adapter (see annotated figure below) comprising:
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a top surface portion (see annotated figure above) having a fitting portion (see annotated figure above) at the center thereof, and
a cylindrical skirt portion (see annotated figure above) extending downward from an outer periphery of the top surface portion (see annotated figure above) and opening at a lower end (see annotated figure above),
wherein at least one or more locking claws (50) engaging with a lower portion of the lip of the pharmaceutical container (figure 19A-19D) are formed on an inner surface at a lower end of the skirt portion (figure 1),
wherein the fitting portion (see annotated figure above) includes a lip (see annotated figure above) and an intermediate tube (see annotated figure above) extending downward from the lip (see annotated figure above), and
the fitting portion fits to a medical instrument ([0041]) used for a closed system drug transfer device (figure 8).
Regarding claim 2, Tremblay discloses a puncturing portion (34) extending downward from the center of a lower surface of the top surface portion (figure 1) and communicating with the interior of the pharmaceutical container inside the skirt portion (figure 19A-19D).
Regarding claim 5, Tremblay discloses wherein at least one or more cutout portions (figure 18, portions of 26 has cut outs and are not sidewalls) are provided in a height direction on an outer peripheral surface of the skirt portion (figure 18).
Regarding claim 6, Tremblay discloses wherein a cover (56) which is removable by fingers is provided on an upper surface of the fitting portion (figure 1, can have the intended use of being removed by fingers).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 3 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tremblay (US 2018/0207062) in view of Kawamura (US 2009/0145876).
Regarding claim 3, Tremblay discloses wherein the lip includes an upper surface (upper surface of lip), a stopper (16), and a lower surface (lower surface of lip), and
at least one place in the upper surface or the lower surface contacts the medical instrument (figures 19A-19D).
Tremblay does not specifically disclose the stopper is rubber.
Kawamura discloses a vial with seal relatively pertinent to problem posed by Applicant of sealing fluid movement. Kawamura teaches using a rubber seal (20) as a possible material for preventing fluid movement before puncture with needle ([0042]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Tremblay by using rubber as a material for the seal in order to prevent material movement.
Regarding claim 7, Tremblay discloses a plastic adapter (24, figures1 and 19A-D) attached the a pharmaceutical container (12) to which a plastic cap (18) is attached, the plastic adapter (see annotated figure below) comprising:
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a top surface portion (see annotated figure above) having a fitting portion (see annotated figure above) at the center thereof, and
a cylindrical skirt portion (see annotated figure above) extending downward from an outer periphery of the top surface portion (see annotated figure above) and opening at a lower end (see annotated figure above),
wherein at least one or more locking claws (50) engaging with a lower portion of the lip of the pharmaceutical container (figure 19A-19D) are formed on an inner surface at a lower end of the skirt portion (figure 1),
wherein the fitting portion (see annotated figure above) includes a lip (see annotated figure above) and an intermediate tube (see annotated figure above) extending downward from the lip (see annotated figure above), and
the fitting portion fits to a medical instrument ([0041]) used for a closed system drug transfer device (figure 8).
Tremblay does not disclose the adapter attaches to a plastic cap attached to a pharmaceutical container (A}, which includes a top surface portion (C1) having an opening (C10) at the center thereof, a cylindrical skirt portion (C2) extending downward from an outer periphery of the top surface portion (C1) and opening at a lower end, and an inner cover (C3) provided inside the skirt portion (C2), in which a coefficient of friction between the inner cover (C3) and a rubber stopper (B) is higher than a coefficient of friction between the inner cover (C3) and the cap (C); and
Kawamura discloses a plastic cap (30) attached to a pharmaceutical container (10) which includes a top surface portion (32) having an opening (31) at the center thereof (figure 1), a cylindrical skirt portion (33) extending downward from an outer periphery of the top surface portion (outer periphery of the top) and opening at a lower end (figure 1), and an inner cover (40) provided inside the skirt portion, in which a coefficient of friction between the inner cover and a rubber stopper is higher than a coefficient of friction between the inner cover (C3) and the cap (the coefficient of friction between the rubber materials would be higher than the rubber with a plastic cover).
Kawamura provides a rubber seal and cap in order to allow the device to move fluid material and prevent movement until necessary. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Tremblay by the Kawamura cap in order to prevent fluid movement until necessary.
Regarding claim 8, Tremblay discloses a puncturing portion (34) extending downward from the center of a lower surface of the top surface portion (figure 1) and communicating with the interior of the pharmaceutical container inside the skirt portion (figure 19A-19D).
Regarding claim 9, Tremblay discloses wherein the lip includes an upper surface (upper surface of lip), a stopper (16), and a lower surface (lower surface of lip), and
at least one place in the upper surface or the lower surface contacts the medical instrument (figures 19A-19D).
Tremblay does not specifically disclose the stopper is rubber.
Kawamura discloses a vial with seal relatively pertinent to problem posed by Applicant of sealing fluid movement. Kawamura teaches using a rubber seal (20) as a possible material for preventing fluid movement before puncture with needle ([0042]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Tremblay by using rubber as a material for the seal in order to prevent material movement.
Regarding claim 10, Tremblay discloses wherein at least one or more cutout portions (figure 18, portions of 26 has cut outs and are not sidewalls) are provided in a height direction on an outer peripheral surface of the skirt portion (figure 18).
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 KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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