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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 14 July 2026 has been entered.
Response to Arguments
Applicant’s arguments, filed 14 July 2026, with respect to the rejection(s) of claim(s) 1-3, 5-10 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 Therefore, the rejection has been withdrawn.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) in view of Lev (US 2015/0231034) and Kawamura (US 2009/0145876).
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 1-3, 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tremblay (US 2018/0207062) in view of Lev (US 2015/0231034) further in view of Kawamura (US 2009/0145876).
Regarding claim 1, Tremblay discloses an adapter (24, figures1 and 19A-D) attached the a pharmaceutical container (12) to which a cap (40) is attached, the adapter covering the cap from an outside thereof and locking the cap (figures 19A-19B), the cap including a top surface portion (42) having an opening (44) at a center thereof, a cylindrical skirt portion (46 and 48) extending downward from an outer periphery of the top surface portion (figure 18) and opening at a lower end, and an inner cover (18, figure 1) provided inside the skirt portion, the adapter (see annotated figure below) comprising:
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449
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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 and cap are plastic, wherein each locking claw has a convex shape extending horizontally in an inner diameter direction of the plastic adapter, which is configured to elastically deform and extend to ride over an outer peripheral surface of the cylindrical skirt portion as the plastic adapter is moved downward relative to the cap, and then after a tip of the convex shape of the locking claw passes over the outer peripheral surface of cylindrical skirt portion, the locking claw returns to an original state so as to lock the plastic adapter on the plastic cap.
Lev discloses a drug vial adapter and teaches wherein each locking claw has a convex shape (48 has a convex shape) extending horizontally in an inner diameter direction of the plastic adapter (figure 2), which is configured to elastically deform and extend to ride over an outer peripheral surface of the cylindrical skirt portion (figure 6) as the plastic adapter is moved downward relative to the cap, and then after a tip of the convex shape of the locking claw (figure 4) passes over the outer peripheral surface of cylindrical skirt portion ([0032])the locking claw returns to an original state so as to lock the plastic adapter on the plastic cap ([0032]).
Lev provides a locking configuration similar to the one provided in Tremblay to join the adapter and cap together ([0032]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Tremblay with the configuration of Lev in order to join the adapter and cap together. The two ways to attach the cap and adapter appear to be functionally equivalent and would perform properly.
Tremblay and Lev does not disclose the adapter and cap are plastic.
Kawamura discloses plastic vials and containers for fluid transfer that teaches the state of the art for these fields utilize plastics ([0004-0006]).
It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Tremblay with the material disclosed by Kawamura since plastic is a standard material used for transferring and holding material.
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 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 on 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 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).
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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449
432
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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 teach wherein 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), a rubber stopper such that the cap is applied and fitted to the rubber stopper, 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 each locking claw has a convex shape extending horizontally in an inner diameter direction of the plastic adapter, which is configured to elastically deform and extend to ride over an outer peripheral surface of the cylindrical skirt portion as the plastic adapter is moved downward relative to the cap, and then after a tip of the convex shape of the locking claw passes over the outer peripheral surface of cylindrical skirt portion, the locking claw returns to an original state so as to lock the plastic adapter on the plastic cap.
Lev discloses a drug vial adapter and teaches wherein each locking claw has a convex shape (48 has a convex shape) extending horizontally in an inner diameter direction of the plastic adapter (figure 2), which is configured to elastically deform and extend to ride over an outer peripheral surface of the cylindrical skirt portion (figure 6) as the plastic adapter is moved downward relative to the cap, and then after a tip of the convex shape of the locking claw (figure 4) passes over the outer peripheral surface of cylindrical skirt portion ([0032])the locking claw returns to an original state so as to lock the plastic adapter on the plastic cap ([0032]).
Lev provides a locking configuration similar to the one provided in Tremblay to join the adapter and cap together ([0032]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Tremblay with the configuration of Lev in order to join the adapter and cap together. The two ways to attach the cap and adapter appear to be functionally equivalent and would perform properly.
Tremblay and Lev do 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), a rubber stopper such that the cap is applied and fitted to the rubber stopper, 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, a rubber stopper (20) such that the cap is applied and fitted to the rubber stopper (FIGURE 1) 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), and a lower surface (lower surface of lip), and
at least one place on the upper surface or the lower surface contacts the medical instrument (figures 19A-19D).
Tremblay does not specifically disclose a second rubber stopper.
It has been held that mere duplication of parts is a design choice and that the duplication has no patentable significance unless a new and unexpected result is produced. Here in this case, 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 the rubber stopper to prevent fluid communication until necessary.
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
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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