Drawings
The drawings were received on 04/23/2026. These drawings are approved by the Examiner.
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.
(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, 2, 4, 11 and 21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Debbs et al. (6,622,864; hereinafter Debbs). Debbs discloses an inner tray/cover (12, 70) for a sterile field fluid system, the cover comprising a bottom layer (12) and a top layer (70) adjacent to the bottom layer, and the top layer having a surface area smaller than a surface area of the bottom layer. Debbs discloses the top layer is substantially planar in shape and at least a portion of the top layer is connected to the bottom layer (column 10, lines 12-67), and at least a portion of the bottom layer is concave in shape (48) and pliable (Debbs discloses the bottom layer 12 is made from a sheet or film of flexible thermoformable plastic resin (column 9, lines 7-10); According to Webster’s II New Riverside University Dictionary: pliable is defined as a/. adaptable to change; b/. flexible;). The bottom layer of Debbs is inherently capable to conform to a shape of a substrate and the top layer is sized to cover the concave portion of the bottom layer (Fig. 4).
As to claim 2, Debbs further discloses the top layer is connected to the bottom layer by an adhesive, bond, thermal weld, or ultrasonic weld, interlocking mechanism, or combinations thereof (column 9, lines 20-31 & column 10, lines 12-67).
As to claim 4, see Fig. 4.
As to claim 11, Debbs discloses the top layer comprises a material which is inherently capable of reuse or re-sterilization (column 9, lines 20-31 & column 10, lines 12-67 & column 14, lines 11-24).
As to claim 21, the concave portion of the bottom layer of the cover of Debbs is inherently capable to be collapsible into a planar configuration since the bottom layer is made from the flexible material.
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.
Claim(s) 5-10, 12-13 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Debbs in view of The Official Notice and/or Sullivan et al. (11,077,996; hereinafter Sullivan).
As to claim 5, Debbs discloses the cover as above having most of the limitations of the claim except for a surface of the top layer comprises at least one opening that allows access to the concave portion of the bottom layer. The Official Notice is taken of an old and conventional practice of providing a cover comprising a bottom layer and a top layer, and a surface of the top layer defines at least one opening that allows access to a cavity in the bottom layer. Sullivan, is cited by way of example only, teaches a cover (100) comprising a bottom layer (300; Figs. 1 & 4), a top layer (200) adjacent to the bottom layer, and a surface of the top layer defines at least one opening (314; Fig. 2) that allows access to a cavity in the bottom layer. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention in view of The Official Notice and/or Sullivan to modify the cover of Debbs so the cover is constructed with a surface of the top layer comprises at least one opening that allows access to the concave portion of the bottom layer to provide more convenience for a user to access to the contents disposed within the concave portion of the bottom layer.
As to claim 6, Sullivan further teaches that the at least one opening comprises a slit (column 7, lines 48-58).
As to claim 7, Sullivan teaches the top layer comprises a flap (218; Fig. 2) as claimed.
As to claim 8, Sullivan teaches the flap comprises a repositionable adhesive or mechanical closure (240; column 8, lines 1-5).
As to claim 9, Sullivan teaches the at least one opening is positioned substantially over the center of the concave portion of the bottom layer.
As to claim 10, Sullivan teaches the top layer is pivotable away from the bottom layer over the center of the concave portion of the bottom layer (Figs. 2-3).
As to claim 12, Sullivan teaches the top layer, the bottom layer, or both comprise a plurality of ply (Fig. 5B).
As to claim 13, Debbs further discloses the top layer, the bottom layer, or both comprise a pre-sterilized material (column 13, lines 1-14 & column 14, lines 11-24).
As to claim 21, to the extent that Debbs fails to disclose the concave portion of the bottom layer is collapsible into a planar configuration, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cover of Debbs so the cover is constructed with the concave portion of the bottom layer is collapsible into a planar configuration to facilitate disposing the bottom layer.
Response to Arguments
Applicant's arguments with respect to all rejected claims have been considered but are deemed to be moot in view of the new grounds of rejection.
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 extension fee 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 date of this final action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUAN K BUI whose telephone number is (571)272-4552. The examiner can normally be reached Generally M-F, 7-4.
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/LUAN K BUI/
Primary Examiner, Art Unit 3736
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