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 .
Response to Amendment
The amendment filed 09/01/2026 (hereafter “the amendment”) has been accepted and entered.
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) 12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merboth (US20030168370A1) and further in view of Carlozzi (US7780004B2)
Regarding claim 12, Merboth teaches a sterile packaging for a sterile object, comprising (see fig.1 that shows the packaging capable of holding a sterile object):
an outer container and forming a first sterile barrier, the outer container having a first receiving compartment in the outer container (see annotated fig.1 below for the outer container firming a first sterile barrier and container having a first receiving compartment); and
an inner container arranged in the first receiving compartment and forming a second sterile barrier, the inner container having a second receiving compartment in the inner container (see annotated fig.1 below for the inner container arranged in the first compartment and forming a second sterile barrier and inner container having a second compartment),
wherein the outer container comprises a first tray closed by a peel-off first lid and comprises a first recess, the first receiving compartment formed in the first recess of the first tray (see annotated fig.1 below for the outer container comprising first tray closed by peel-off lid and with a first recess with the receiving compartment in the first recess; “It is an object of the invention to provide a packaging system which holds specially constructed tissue forms in a double sterile condition which allows a user to peel away a cover to reach the inner tissue container and then peel away a cover to provide access to the tissue form.”-0017 so the covers/lids can be peeled off),
wherein the inner container comprises a second tray closed by a peel- off second lid and comprises a second recess, the second receiving compartment formed in the second recess of the second tray (see annotated fig.1 above for the second tray with a peel off lid and the second recess with the compartment in the recess; “It is an object of the invention to provide a packaging system which holds specially constructed tissue forms in a double sterile condition which allows a user to peel away a cover to reach the inner tissue container and then peel away a cover to provide access to the tissue form.”-0017 so the covers/lids can be peeled off), and
wherein the second recess comprises a projection that rests on a surface of the first recess in the first receiving compartment and forms a pivotal point for tilting movement of the inner container relative to the outer container (see annotated fig.1 below for the second recess comprising a projection that rests on the surface of the first recess when assembled and forms a pivotal point for tilting movement of the inner container relative to the outer). Merboth does not teach a outer packaging and the outer container arranged in the outer packaging.
Carlozzie does teach a outer packaging and the outer container arranged in the outer packaging (fig.2 shows the outer packaging B and outer container arranged in the packaging). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sterile packaging disclosed by Merboth by adding the outer packaging as disclosed by Carlozzie in order to provide extra layer of security for sterling purposes due to the breakable sealing tape and a window that will show if the packaging has been tampered with.
Annotated fig.1 of Merboth
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Regarding claim 13, the references as applied to claim 12 above discloses all the limitations substantially claimed. Merboth as modified in claim 12 further teaches wherein: the first tray comprises a peripheral edge section that surrounds the first recess and to which the peel-off first cover is attached; and the second tray comprises a peripheral edge section that surrounds the second recess and to which the peel-off second cover is attached (see annotated fig.1 above where the both peel off lids are attached to the peripheral edges of the containers and seal the recess).
Regarding claim 14, the references as applied to claim 12 above discloses all the limitations substantially claimed. Merboth as modified in claim 12 further teaches wherein: the sterile packaging extends along a longitudinal direction (see annotated fig.1 for the packaging extending along a longitudinal direction); the first tray comprises a first end section for holding the outer container and a second end section opposite the first end section in the longitudinal direction (see annotated fig.1 for the first tray with first end second for holding the outer container and second end section opposite of the first end section in the longitudinal direction); the first recess is formed in the longitudinal direction between the first end section and the second end section (see annotated fig.1 above for the first recess being formed between two end sections); and a thinned section is formed between the second end section and the first recess to allow for creasing of the second end section (see annotated fig.1 below for the thin section capable of allowing for creasing of the second section).
Regarding claim 15, the references as applied to claim 12 above discloses all the limitations substantially claimed. Merboth as modified in claim 12 further teaches wherein one or both of: the outer packaging comprises a predetermined breaking line for opening the outer packaging; and the outer packaging comprises a transparent window (fig.2 shows the breakable sealing tape 72 that breaks at in the middle and the window 90; it is noted applicant has to defined the structure of the predetermined breaking line).
Regarding claim 16, the references as applied to claim 12 above discloses all the limitations substantially claimed. Merboth as modified in claim 12 further teaches wherein a carrier is arranged in the second receiving compartment and comprises a shaped part with a third receiving compartment for the sterile object (see annotated fig.1 above for the carrier arranged in the second receiving compartment and comprises a shaped part with a 3rd receiving compartment for a sterile object).
Regarding claim 17, the references as applied to claim 16 above discloses all the limitations substantially claimed. Merboth as modified in claim 16 further teaches wherein the carrier has an angled surface at one end section, and an end region of the angled surface rests on a surface of the second recess in the second receiving compartment to form a pivotal point for a tilting movement of the carrier relative to the inner container (see annotated fig.1 above for the carrier having two angled surface on end section and end region of the angled surface rests on the surface of the second recess when assembled and can form a pivotal point for tilting).
Regarding claim 18, the references as applied to claim 16 above discloses all the limitations substantially claimed. Merboth as modified in claim 16 further teaches wherein one or both of: the shaped part exerts a clamping action on the sterile object; and the sterile object is a bone screw (see annotated fig.1 above for shaped part exerts clamping action on the sterile object and the sterile object cane be a bone screw; it is noted that sterile object is not positively claimed).
Allowable Subject Matter
Claim 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 09/01/2026 have been fully considered but they are not persuasive. Applicant argues the limitation “wherein the second recess comprises a projection that rests on a surface of the first recess in the first receiving compartment and forms a pivotal point for tilting movement of the inner container relative to the outer container” that it is not taught by the prior art as the “flange 47” as applicant annotates it on page 7 of arguments will not let projection to create a “pivotable point” and will prevent the tilting of the inner container this is not persuasive as the applicant has not claimed the limitation as applicant has argued and shown its in own drawings. Claim recites a projection that rests on “a surface of the first recess in the first receiving compartment” it can be any surface of the first compartment i.e. the inner container can be lifted up and projection be placed on the side wall of the first compartment and create a “pivotable point” for tilting movement relative to the outer container. Nowhere in the claim does it recite where the “pivotable point” is or which “a surface” of the first compartment does the projection rests on. Claim as written the surface can be any surface the projection is capable of be in contact with, which the prior art can, and title which the prior art can. No other argument was made. Applicant should at least define which surface or where the pivotable point occurs to get over the prior art.
Conclusion
THIS ACTION IS MADE FINAL. 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 PRINCE PAL whose telephone number is (571)272-7525. The examiner can normally be reached M-Th, 9:30 AM - 7:30 PM (EST).
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/PRINCE PAL/Primary Examiner, Art Unit 3735
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