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 .
This office action is in response to the reply filed on 5/14/2026, wherein claims 1-3, 5, 7-8, 11-13 and 27 were amended. Claims 1-14 and 24-32 are pending.
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 2 and 12 (and claims 3-5 which depend therefrom) 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 2 is rendered indefinite since it is unclear how each intermediate narrowed portion can include a first geometric feature and a second geometric feature, when claim 1 (lines 15-17) only defined each narrowed intermediate portion having a single geometric feature. Examiner suggests amending claim 1 to read “wherein each of the intermediate narrowed portions and the recessed portion includes a first sidewall, a second sidewall, a base, and at least one geometric feature projecting into each of the intermediate narrowed portions and the recessed portion”. Then claim 2 should clarify that the at least one geometric feature includes the first and second geometric features.
Claim 12 is rendered indefinite since it is unclear how the claim can be referring to the geometric feature on the first sidewall and the geometric feature on the second sidewall, when claim 11 only defined at least one of the first sidewall, the second sidewall and base having a geometric feature. Claim 12 should positively recite a geometric feature on the first sidewall and a geometric feature on the second sidewall before referring to such elements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 11, 12, 14 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mismar et al. (US 2021/0060258).
Regarding claim 11, Mismar discloses a packaging (at 800 in Figs. 10A-10C) capable of holding a syringe, the packaging comprising: a tray (at 800) having an opening (top opening of 800), a cavity (inner volume of tray 800) including a plurality of cavity portions (See first and second cavities in Fig. 10C labeled below), a flange portion (See Fig. 10C labeled below), and a recessed portion (See Fig. 10C labeled below); wherein at least one (first cavity) of the plurality of cavity portions is connected to the flange portion by the recessed portion (as shown in Fig. 10C labeled below), and capable of receiving a plunger rod of the syringe, wherein at least two of the plurality of cavity portions are connected to one another by an intermediate narrowed portion (See Fig. 10C labeled below), each of the intermediate narrowed portion and the recessed portion including a first sidewall, a second sidewall, and a base, wherein at least one of the first sidewall, the second sidewall, and the base of each of the intermediate narrowed portion and the recessed portion includes a geometric feature (at 810/810/820 in Fig. 10A) extending away from the corresponding sidewall or base and projecting into the intermediate narrowed portion and the recessed portion to position the syringe away from the corresponding sidewall or base; a lip (See Fig. 10C labeled below) surrounding the opening, wherein the lip extends radially outward from the cavity and defines a periphery of the tray; and a removable cover ([0064]) having a periphery that is adhered to the lip, wherein the removable cover is permeable to a gaseous sterilant ([0056]).
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Regarding claim 12, Mismar discloses the geometric feature on the first sidewall of the intermediate narrowed portion is a first geometric feature (upper 810 in Fig. 10A) and the geometric feature on the second sidewall of the intermediate narrowed portion is a second geometric feature (lower 810 in Fig. 10A), and a distance between the first geometric feature and the second geometric feature ranges from about 5.5 mm to about 6.5 mm ([0019]).
Regarding claim 14, Mismar discloses the gaseous sterilant is ethylene oxide ([0071]).
Regarding claim 25, the packaging of Mismar is capable of holding a syringe pre-filled with aflibercept.
Allowable Subject Matter
Claims 1, 6-10, 24 and 26-32 are allowed.
Claims 2-5 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.
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
In view of Applicant's amendment, the search has been updated, and new prior art has been identified and applied. Applicant's arguments have been considered but are moot in view of the new ground(s) of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 STEVEN A REYNOLDS whose telephone number is (571)272-9959. The examiner can normally be reached M-F 9am-5pm.
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, Anthony Stashick can be reached at (571) 272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735
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