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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-6 and 8-10 in the reply filed on 11/24/2025 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 8, “the first lower wall” in line 13 lacks antecedent basis. It is treated as “the lower wall”.
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.
Claim(s) 1-6 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hasumi et al (US 2017/0143893) in view of Yin et al (US 10,857,324).
Regarding claim 1, Hasumi discloses a medical device package comprising: a medical device 5; and a packaging container 3 that holds the medical device (fig 2), wherein: the packaging container comprises: a bottomed container main body including a holding recess portion holding the medical device (figs 2 and 3) and an opening end portion 33 surrounding the holding recess portion (fig 3), and a sealing film 4 formed in a sheet shape and bonded to the opening end portion of the container main body to seal the holding recess portion (fig 1; ¶62), the container main body comprises a take-out recess portion 35 provided to be adjacent to the medical device and the holding recess portion (fig 2) and capable of receiving a finger of an user (¶62 – opening for taking the liquid injection device out of housing).
While Hasumi substantially discloses the invention as claimed, it does not disclose the sealing film comprises an unsealing assistance portion for facilitating breakage of a part of the sealing film, at least at a position facing the take-out recess portion.
Yin discloses a medical package with a sealing film (fig 4b) and an unsealing assistance portion (224/222) for facilitating breakage of a part of the sealing film, at least at a position facing the take-out recess portion (fig 7). The advantage of this unsealing assistance portion is it both facilitates opening the package (Col.10 ll 28-29) and allows the unsealing assistance portion to be pressed against a hard surface in order to prevent movement of the container (Col.10 ll 31-34). Even further, the unsealing assistance portion may be later resealed to allow for easier disposal of the system (Col.10 ll 35-38).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hasumi such that the sealing film comprises an unsealing assistance portion for facilitating breakage of a part of the sealing film, at least at a position facing the take-out recess portion as taught by Yin to facilitate opening the package, allows the unsealing assistance portion to be pressed against a hard surface in order to prevent movement of the container and allow for easier disposal of the system after resealing.
Regarding claim 2, wherein: the unsealing assistance portion comprises a breaking line cut out in a thickness direction of the sealing film and extending along the sealing film (see combination in claim 1, 224 in fig 4b with corresponding section Col.10 ll 11-12 of Yin).
Regarding claim 3, wherein: a part of the breaking line faces the medical device (see combination in claim 1 and fig 7 of Yin).
Regarding claim 4, wherein: the unsealing assistance portion comprises a plurality of breaking lines cut out in a thickness direction of the sealing film and extending along the sealing film (see combination in claim 1, 224 in fig 4b with corresponding section Col.10 ll 11-12 of Yin).
Regarding claim 5, wherein: the breaking line comprises perforations (see combination in claim 1, 224 in fig 4b with corresponding section Col.10 ll 11-12 of Yin).
Regarding claim 6, wherein: the breaking line is formed along a part of an outer shape of the medical device when viewed from an opening direction of the opening end portion (see combination in claim 1, and fig 7 of Yin).
Regarding claim 8, Hasumi discloses a medical device package comprising: a medical device 5; and a packaging container 3 that holds the medical device (fig 2); wherein: the packaging container comprises: a container main body comprising: a plurality of lateral walls (see annotated figures below), a flange 33 extending outward from upper ends of the plurality of lateral walls, a lower wall (see annotated figures below), a plurality of additional walls extending downward from the lower wall (see annotated figures below), an upper recess defined by the plurality of lateral walls, and the
While Hasumi substantially discloses the invention as claimed, it does not disclose the sealing film comprising a breaking line, a portion of which faces the recess portion of the lower recess.
Yin discloses a medical package with a sealing film (fig 4b) and a breaking line 222/224 for facilitating breakage of a part of the sealing film, a portion of which facing the recess portion (fig 7). The advantage of this unsealing assistance portion is it both facilitates opening the package (Col.10 ll 28-29) and allows the unsealing assistance portion to be pressed against a hard surface in order to prevent movement of the container (Col.10 ll 31-34). Even further, the unsealing assistance portion may be later resealed to allow for easier disposal of the system (Col.10 ll 35-38).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hasumi such that the sealing film comprises a breaking line, a portion of which faces the recess portion of the lower recess as taught by Yin to facilitate opening the package, allows the unsealing assistance portion to be pressed against a hard surface in order to prevent movement of the container and allow for easier disposal of the system after resealing.
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Regarding claim 9, wherein: the breaking line comprises perforations (see combination in claim 8, 224 in fig 4b with corresponding section Col.10 ll 11-12 of Yin).
Regarding claim 10, wherein: the breaking line is formed along a part of an outer shape of the medical device in a top view (see combination in claim 8, and fig 7 of Yin).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783