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 .
Election/Restrictions
Applicant’s election without traverse of Species 1 (Figures 1-4) in the reply filed on 11/19/2025 is acknowledged. In the reply, Applicant indicated that claims 1-6 and 15 read on the elected species. Claims 7-14 are withdrawn as being directed toward non-elected species.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Levenberg et al. (US 4,449,631) in view of Kuster (US 3,498,448).
Regarding claims 1 and 16, Levenberg discloses a medical supply package (at 10 - See Figs. 1-2) storing a medical supply (element 11), the medical supply package comprising: a first sheet member (at 16 in Fig. 2); and a second sheet member (at 17 in Fig. 2) facing the first sheet member (as shown in Fig. 2); wherein: the medical supply is stored between the first sheet member and the second sheet member (as shown in Fig. 2); the first sheet member and/or the second sheet member comprises a storage recess (recess at 27 in Fig. 2) having a shape corresponding to an outer shape of the medical supply in a central portion (as shown in Figs. 1-2); the first sheet member and the second sheet member comprise: abutting portions surrounding an outer periphery of the storage recess and facing each other (as shown in Fig. 2), an annular seal portion (at 24 – See Fig. 1 labeled below) formed on the abutting portions and surrounding and hermetically sealing the storage recess (See column 2, lines 15-16 and column 3, lines 10-11), and a non-seal portion (surrounding element 24 at the left side – See Fig. 1 labeled below) provided on an outer side of the annular seal portion.
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Levenberg discloses the claimed invention except for the breakable portion. However, Kuster teaches a medical package (package 20 - See Figs. 1-5) comprising a first sheet member (at 2) and a second sheet member (at 3) facing the first sheet member, wherein a medical supply (at 1) is stored between the first and second sheet members in a storage recess (See recess below 2 in Fig. 2), wherein the second sheet member comprises a linear or band-shaped breakable portion (portion between 6 and 7 in Fig. 3, extending the width of the package), the breakable portion comprising: an opening start portion (edge portion between 6 and 7 in Fig. 3) including a start end at the edge of the package, a peelable portion (portion between 4 and 5 in Fig. 3) continuous from the opening start portion and crossing a part of the seal portion between the sheet members, and a breakable portion main part (at 8 in Fig. 3) continuous from the peelable portion and crossing the storage recess, wherein the breakable portion does not inhibit airtightness of the seal portion (column 2, lines 12-27), for the purpose of providing access to the medical supply held within the storage recess while maintaining sterility (column 1, lines 14-19 and lines 25-38). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the package of Levenberg with a breakable portion as taught by Kuster in order to allow for convenient opening while maintaining sterility of the contents.
Regarding claim 2, Levenberg discloses the first sheet member comprises a first sheet-side recess; the second sheet member comprises a second sheet-side recess; and the storage recess is formed by the first sheet-side recess and the second sheet-side recess (See Fig. 2 labeled above).
Regarding claim 3, Levenberg-Kuster discloses the first sheet member and the second sheet member comprise an opposing non-seal portion (surrounding element 24 at the right side – See Fig. 1 of Levenberg labeled above) provided in a position opposite the non-seal portion on an outer side of the annular seal portion; wherein: the breakable portion (as taught by Kuster) comprises: a second peelable portion (portion between 4 and 5 at the opposite side of the package of Kuster) continuous from the breakable portion main part and crossing a part of the annular seal portion, and a second opening start portion (edge portion at 24 in Fig. 3) continuous from the second peelable portion and including a start end in the opposing non-seal portion.
Regarding claim 4, Levenberg-Kuster discloses the breakable portion is able to be cut off from the medical supply package (as shown in Fig. 5 of Kuster).
Regarding claim 5, Kuster teaches the breakable portion comprises a first breakable linear portion (at 6) and a second breakable linear portion (at 7) facing the first breakable linear portion, where the first and second breakable linear portions extends over substantially an entire length of the breakable portion (as shown in Fig. 3).
Regarding claim 6, Levenberg-Kuster discloses the first breakable linear portion and the second breakable linear portion are formed of cuts; the cuts of the first breakable linear portion and the second breakable linear portion do not completely penetrate the first sheet member and do not penetrate the second sheet member in the annular seal portion; and the cuts of the first breakable linear portion and the second breakable linear portion do not completely penetrate the first sheet member and do not penetrate the second sheet member on an inner side of the annular seal portion. Levenberg-Kuster discloses the claimed invention except for the breakable linear portions being formed by intermittently formed cuts. However, official notice is taken that it is old and conventional to form tear lines from intermittent cuts/scores. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the official notice to have formed the breakable linear portions of Levenberg-Kuster from intermittent cuts/scores in order to allow for easy removal of the breakable portion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN A REYNOLDS whose telephone number is (571)272-9959. The examiner can normally be reached M-F 9am-5pm.
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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735