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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 18, 2026 has been 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.
Claims 1-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Okihara (U.S. 2015/0182686) in view of Deutschle et al. (U.S. 2015/0306259) and Robinson (U.S. 3,354,515). Okihara teaches a packaging 1, shown in figure 1, wherein the first tub 1 has a sterilization-gas-permeable cover film 31 (paragraph [0044]).
Okihara discloses the claimed invention except for the second tub and the spacer structure. Deutschle et al. teaches that it is known to provide a packaging with two stacked tubs (see figure 4b). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the assembly of Okihara with a second tub stacked on the first tub, as taught by Deutschle et al., in order to compactly store multiple containers.
Robinson teaches that it is known to provide a packaging with a spacer structure (see clamp; figures 1 and 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the modified assembly of Okihara with a spacer structure, as taught by Robinson, in order to securely stack multiple containers.
Okihara, as modified above teaches a spacer structure (“clamp” of Robinson; figures 1 and 2 of Robinson) arranged between the second tub (as modified by Deutschle et al.) and the first tub 1, said second tub (as modified by Deutschle et al.) and said first tub 1 being configured for the transport or storage of a plurality of medical containers (capable of transporting medical containers), wherein the spacer structure comprises a central portion (shown at lead line 68 of Robinson), supporting arms (at 61 of Robinson) outwardly extending from said central portion (figure 1 of Robinson), said supporting arms (at 61 of Robinson) and said central portion (at lead line 68 of Robinson) being configured to be located between a sterilization-gas-permeable cover film (element 31; paragraph [0044]) of the first tub 1 and a bottom of the second tub (as modified by Deutschle et al.), wherein an outward portion of the supporting arms (61 of Robinson) rest on top of the first tub (as shown at 71 of Robinson), wherein the supporting arms (at 61 of Robinson) comprise first maintaining means (62, 63 of Robinson) configured to prevent radial displacements of the first tub relative to the spacer structure, and second maintaining means (61, 63 of Robinson) configured to prevent radial displacements of the second tub relative to the spacer structure, wherein an inner end (located radially inwardly from 61, 63 of Robinson) of the supporting arms rests on the sterilization-gas-permeable cover film 31 of the first tub 1 (see figure 2b where film 31 is sealed against upper surface of rim at 5 of Okihara).
Regarding claim 2, the supporting arms of Robinson are plate-shaped (figures 1 and 2).
Regarding claim 3, the supporting arms at 61 of Robinson are distributed at regular angles around the vertical axis A (figure 1).
Regarding claim 4, the supporting arms at 61 of Robinson form a X-shaped spacer structure (figure 1).
Regarding claim 5, at least two of the supporting arms at 61 of Robinson are configured to engage a same side of the first tub (figure 3 of Robinson).
Regarding claim 6, the first and the second maintaining means include protrusions protruding from, respectively, a first side and an opposite second side of the supporting arms (figure 2 of Robinson).
Regarding claim 7, the protrusions of Robinson are shaped to engage lateral sides or corners of, respectively, the first tub or the second tub (figure 3 of Robinson).
Regarding claim 10, the spacer structure is arranged between a cover film 31 of the first tub 1 of Okihara and a bottom of the second tub 1 (as modified by Deutschle et al.).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Okihara (U.S. 2015/0182686) in view of Deutschle et al. (U.S. 2015/0306259) and Robinson (U.S. 3,354,515), as applied to claim 1 above, and further in view of Levine (U.S. 6,612,439). The modified packaging of Okihara discloses the claimed invention except for the polymer material of the spacer. Levine teaches that it is known to provide a spacer made of a polymer material (see col. 2 lines 64-67). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the modified assembly of Okihara with the spacer being made from a polymer material, as taught by Levine, in order to use a lightweight material and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Okihara (U.S. 2015/0182686) in view of Deutschle et al. (U.S. 2015/0306259) and Robinson (U.S. 3,354,515), as applied to claim 1 above, and further in view of Meurer et al. (DE 4101837A1). The modified packaging of Okihara discloses the claimed invention except for the notch or window. Meurer et al. teaches that it is known to provide a spacer with a notch or a window (see element 6). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the modified assembly of Okihara with the notch or window, as taught by Meurer et al., in order to save on material costs by using less material to form the spacer.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Okihara (U.S. 2015/0182686) in view of Deutschle et al. (U.S. 2015/0306259) and Robinson (U.S. 3,354,515), as applied to claim 1 above, and further in view of Togashi (EP 2,119,463A1). The modified packaging of Okihara discloses the claimed invention except for the single sealing bag. Togashi teaches that it is known to provide an assembly with a single sealing bag (see element 50). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the modified assembly of Okihara with the single sealing bag, as taught by Togashi, in order to seal the containers and retain the assembly together.
Response to Arguments
Applicant's arguments filed March 18, 2026 have been fully considered but they are not persuasive. Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection. The new primary reference of Okihara (U.S. 2015/0182686) has been added to the rejection for the teaching of providing a container with a cover that is a sterilization-gas-permeable cover film which rests on the flange of the container (element 31; paragraph [0044]).
Conclusion
THIS ACTION IS MADE NON-FINAL.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIKI MARINA ELOSHWAY whose telephone number is (571)272-4538. The examiner can normally be reached Monday through Friday 7: 00 a.m. to 3:00 p.m..
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/NIKI M ELOSHWAY/Examiner, Art Unit 3736