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 .
Terminal Disclaimer
The terminal disclaimer filed on 3/4/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 12, 387, 077 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendment
Receipt is acknowledged of applicant’s amendment filed on 3/4/26. Claim 1 amended. Claims 1-20 are pending and an action on the merits is as follows.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Leibbrand et al. US Publication No. 2023/0169295 et al. US Publication No. 2023/0169295 which claims priority to us-provisional-application US 63124126 filed on 12/11/20 and us-provisional-application US 63108497 filed on 11/2/20.
Re Claim 1, : Leibbrand discloses a labelling assembly for a multi-part container, comprising:
- a sleeve-shaped supplementary element (label 80 + tip cap) which includes a coupling structure and which is configured to be coupled, with respect to a longitudinal axis of the supplementary element 104 by means of the coupling structure to an outer surface of a primary closure for the container and to surround the primary closure, and - a label (label material ), wherein the label 80 and the supplementary element 104 are formed in coordination with each other and coupled to each other so that the label can be attached to the primary closure of the container by means of the supplementary element 104, and wherein the supplementary element 104 covers the outer surface of the primary closure only partly along the longitudinal axis and surrounds only an upper section of the primary closure (Fig. 7c) (P81, P82) .
Re Claim 2: Leibbrand discloses the labelling assembly according to claim 1, wherein, with respect to the longitudinal axis, the supplementary element 104 has on an inner surface a circumferential contour which forms a negative shape with respect to a circumferential contour on a respective outer surface of the primary closure (Fig. 7c) .
Claim 3 (Original): Leibbrand discloses the labelling assembly according to claim 1, wherein the supplementary element 104 is configured to be pressed or pushed onto the primary closure so that a direct contact is made between the supplementary element (104) and the outer surface of the primary closure, at least in sections, which establishes a coupling comprising an interference fit (Fig. 7c ; P81, P82).
Re Claim 4: Leibbrand discloses the labelling assembly according to claim 1, wherein the supplementary element (104) is formed opened at a top with respect to the longitudinal axis (Fig. 7c) .
Re Claim 5: Leibbrand discloses the labelling assembly according to claim 1, wherein the supplementary element (104) is formed closed at a top with respect to the longitudinal axis and comprises a cover element or end wall (Fig. 7c).
Re Claim 6: Leibbrand discloses the labelling assembly according to claim 1, wherein the supplementary element (104) is formed slotted on a side wall (Fig. 7c).
Re Claim 7: Leibbrand discloses the labelling assembly according to claim 1, wherein the supplementary element 104 is made of a transparent material (P57, P18).
Re Claim 8: Leibbrand discloses the labelling assembly according to claim 1, wherein the supplementary element 104 comprises an outer surface with a roughened structure and/or a microstructure (Fig. 7c).
Re Claim 9: Leibbrand discloses the labelling assembly according to claim 1, wherein the supplementary element 104 comprises an outer surface with a corrugation which establishes a handle structure for executing an opening movement, when the supplementary element (104) is applied to the primary closure (Fig. 7c, P83-84).
Re Claim 10: Leibbrand discloses The labelling assembly according to claim 1, wherein the supplementary element (104) comprises an outer surface with a smooth structure (P81-P83).
Re Claim 11, : Leibbrand discloses the labelling assembly according to claim 1, wherein the supplementary element (7B) is formed with full-surface around a longitudinal axis of the primary closure (Figs. 7b) .
Re Claim 12 : Leibbrand discloses the labelling assembly according to claim 1, wherein the supplementary element (104) is formed partially around a longitudinal axis of the primary closure (Fig. 7c, P81-83). ‘
Re Claim 13: Leibbrand discloses The labelling assembly according to claim 1, wherein the supplementary element (104) is formed such that after application, when the supplementary element (104) is coupled to an area of the primary closure, the area of the primary closure has a same circumference as a container body of the container (P81-83; Fig. 7c).
Claim 14: Leibbrand discloses the labelling assembly according to claim 1, wherein the supplementary element (104) comprises a recess which extends into or through a wall of the supplementary element and provides a channel for fluid exchange between an inner space and an outer space of the supplementary element (P7).
Re Claim 15: Leibbrand discloses the labelling assembly according to claim 1, wherein the label comprises a severing element 88 in form of a perforation, a tear strip and/or a film element with a predetermined tear resistance (P83).
Claim 16: Leibbrand discloses the labelling assembly according to claim 15, wherein the label comprises an adhesive-free surface in an area of the severing element (P83).
Claim 17: Leibbrand discloses a system, comprising: - a primary closure which can be coupled to a container body of a container, and - a labelling assembly according to claim 1, which is coupled to the primary closure such that the supplementary element (104) is attached to the primary closure and the label (80) is attached to the supplementary element (P81-82, Fig. 7c).
Re Claim 18: Leibbrand discloses the system according to claim 17, wherein the container is a Luer-Lock syringe and the primary closure is a Luer-Lock closure and the container body is a syringe body (P29-30, P34-37).
Re Claim 19: Leibbrand discloses the system according to claim 17, wherein the container is a needle-locked syringe and the primary closure is a needle-lock closure and the container body is a syringe body (P17, P81).
Re Claim 20: Leibbrand discloses the system according to claim 17, wherein the label is attached to the supplementary element (104) and to the container body (Fig. 7c).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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.
Applicant amended the claims with new limitations which necessitated new search and consideration. Therefore this action is made final.
Conclusion
The following reference is cited but not relied upon:
Blair et al. discloses a container that includes a vial, cap, and one or more wireless transponders secured to the cap, the vial or a jacket to store and identify samples of biological material at cryogenic temperatures (e.g., vitrified biological samples), for instance held by cryopreservation storage devices.
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 SONJI N JOHNSON whose telephone number is (571)270-5266. The examiner can normally be reached 9am-9pm.
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SONJI N. JOHNSON
Examiner
Art Unit 2876
/SONJI N JOHNSON/Primary Examiner, Art Unit 2876
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