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 .
Applicant’s election without traverse of the invention of Group I, claims 1-13 in the reply filed on 9/17/25 is acknowledged. Applicant’s election of the species of Group 1, represented by Figs. 1-11 is also acknowledged, as is applicant’s indication that claims 7, 8 and 13 are withdrawn as being directed to non-elected species. Finally, the examiner also acknowledges the amendments to the Group II claims, claims 14-18, to recite a medical device packaging and to make them dependent on claim 1.
Claims 7, 8 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/17/25. The examiner notes that the restriction as to claims 14-18 is withdrawn in view of the amendments to claim 14. An action on the merits of claims 1-6, 9-12 and 14-18 follows.
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 1-6, 9-12 and 14-18 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. Claim 1 is indefinite because given the wording of the last line thereof, it is not clear whether what is functionally claimed is an injection device or an on-body injector.
Claim 3 is indefinite because the claimed “said sequence”, the sequence of claim 2, is the sequence of moving the at least two panels in the claim from the folded position to the unfolded position, and therefore, the further limitation in claim 3 is inconsistent with the noted sequence. Said a little differently, claim 3 is indefinite because the sequence of claim 3 cannot include opening the first compartment after moving one of the two panels as claimed, since the sequence in claim 2 is limited to unfolding the panels.
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 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero et al. (11,738,171). Glithero discloses a medical device packaging in Figs 37A and 37B that meets most of the features of the claims. Thus, the claimed box can be catheterization tray 200b, the claimed cover can be sterile wrap 130b and the claimed instructions provided on a foldable portion (side panel 202b and top panel 201b) of the box can be procedural indicators 260b that as shown in Fig 37B can be located on the inner surface of side panel 202b and top panel 201b. See also column 40 last paragraph.
Accordingly, the claimed structure that is missing from Glithero is that the box comprises independently openable first and second compartments. On the other hand Glithero discloses these features in other embodiments, and also suggests the use of features of these embodiments in other embodiments disclosed in the reference. For example, see column 18. For example, note the described embodiments of catheterization trays having compartments (such as compartments 1-3 in Fig 2) the compartments being sealed in some further embodiments such that the compartments are independently openable. In another example, see lines 39-41 of the same column. It would have been obvious in view of Glithero to provide the Fig 37 embodiment box with independently openable first and second compartments (sealed compartments), for the purpose of more securely and/or safely containing some catheterization components therein. The examiner notes that such compartments can hold some medicament vial or cartridge and an injection device as functionally recited in the last paragraph of claim 1.
The two panels of claim 2 can be the noted side panel 202b and top panel 201b.
Regarding claims 3 and 4, Glithero contemplates in the parts of the reference pointed to above sequentially opening compartments, and doing so after the catherization trays are accessed.
Claims 9-11 and 14-18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB K ACKUN whose telephone number is (571)272-4418. The examiner can normally be reached Monday-Thursday 11am-7pm.
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 at (571) 270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACOB K ACKUN/Primary Examiner, Art Unit 3736