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.
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 (bend portion of 62 of Robinson) of the supporting arms and the central portion (horizontally extending portion of 62)rest 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 July 27, 2026 have been fully considered but they are not persuasive. Applicant argues that Robinson teaches away from placing a clamp between a top of the bottom container and a bottom of the top container. The reference of Robinson is used in the rejections above as a secondary reference wherein the spacer of Robinson is applied to the modified container assembly of Okihara. The orientation of the containers of Robinson is not used to modify the primary reference. The orientation of the stacked containers is taught by Deutschle et al. Robinson is applied in the rejection above for the teaching of using a spacer between two stacked containers. It has been held that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that Robinson does not teach that the inner end of the supporting arms of the clamp rest on the bottom container. Amended claim 1 recites that “an inner end of the supporting arms and the central portion rest on the sterilization-gas-permeable cover film of the first tub.” The primary reference of Okihara teaches a tub with a gas-permeable cover. The cover is secured to the top rim of the tub and extends across the top opening of the tub. When the spacer of Robinson is applied to the top of the tub of Okihara, an inner end of the supporting arms (considered axially inner, which is the bend portion of 62), and the central portion (which comprises the horizontally extending portion of 62) rest on the perimeter of the gas permeable cover film of the first tub of Okihara. The claims do not define the central portion sufficiently to overcome the central portion of Robinson which comprises both the horizontally extending portions of 61 and the horizontally extending portions of 62.
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 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E. Aviles can be reached on 571-270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIKI M ELOSHWAY/Examiner, Art Unit 3736
/ORLANDO E AVILES/Supervisory Patent Examiner, Art Unit 3736
