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 Group 1 (claims 1-14 and 24-32) in the reply filed on 2/2/2026 is acknowledged.
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 1-10, 24 and 26-32 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 rendered indefinite by the terms “a first cavity portion”, “a second cavity portion” and “a third cavity portion”, in lines 6-7, since it is unclear if the first, second and third cavity portions are referring to the at least three cavity portions previously defined in line 2 or different cavity portions. For examination purposes, Examiner interprets the first, second and third cavity portions as referring to the at least three cavity portions defined in line 2 of claim 1.
Claim 3 is rendered indefinite by the limitation “less than about 2.0 mm than the” since it is unclear what is being claimed. For examination purposes, Examiner interprets the claim limitation as “a distance between the first geometric feature and the second geometric feature is about 2.0 mm less than the width of the portion of the syringe contained within the narrowed portions”.
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 1-5, 7-14, 24-25 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mismar et al. (US 2021/0077645).
Regarding claim 1, Mismar discloses a packaging (packaging 200 – shown in Figs. 3A-3C) comprising: a tray having an opening (see Fig. 3A labeled below), a cavity (cavity within the opening) including at least three cavity portions (see three cavity portions labeled in Fig. 3A below), a plurality of sidewalls (see Fig. 3A labeled below), and a base (bottom surface at 214 in Fig. 3A); and a syringe (at 10 in Fig. 3C) contained within the cavity, wherein the sterile syringe is pre-filled with a medicament or other fluid (see [0037]); wherein a first cavity portion (see Fig. 3A labeled below) comprises a plunger rod of the syringe (left-most portion of syringe 10 in as shown in Fig. 3C), a second cavity portion (see Fig. 3A labeled below) comprises a barrel of the syringe (middle portion of syringe 10 as shown in Fig. 3C), and a third cavity portion (see Fig. 3A labeled below) comprises a needle attachment portion of the syringe (right-most portion of syringe 10 as shown in Fig. 3C), wherein the three cavity portions are connected to one another by intermediate narrowed portions (see Fig. 3A labeled below), and wherein each of the narrowed portions includes a first sidewall (see Fig. 3A labeled below), a second sidewall (see Fig. 3A labeled below), a base (portion of the narrowed portion in which element 220 is disposed), and a plurality of geometric features (at 210/220 in Fig. 3A) projecting into the narrowed portions to position the syringe away from the plurality of sidewalls.
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Regarding claim 2, Mismar discloses the first sidewall of the narrowed portion includes a first geometric feature (top-most element 210 in Fig. 3A) and the second sidewall of the narrowed portion includes a second geometric feature (bottom-most element 210 in Fig. 3A).
Regarding claim 3, Mismar discloses a distance between the first geometric feature and the second geometric feature is about 2.0 mm less than the width of the portion of the syringe contained within the narrowed portions (based on the barrel diameters described in [0098]).
Regarding claim 4, Mismar discloses a distance between the first geometric feature and the second geometric feature ranges from about 5.5 mm to about 6.5 mm (based on the barrel diameters described in [0098]).
Regarding claim 5, Mismar discloses the base of the narrowed portion includes a third geometric feature (at 220 in Fig. 3A).
Regarding claim 7, Mismar discloses the first cavity includes a flange portion (portion to the left of left-most 210 in Fig. 3C that accommodates the wide flange portion of the syringe 10) configured for holding a flange of the syringe.
Regarding claim 8, Mismar discloses a recessed portion is located between the flange portion and the first cavity (as shown in Fig. 3C).
Regarding claim 9, Mismar discloses each of the at least three cavity portions has a rectangular shape (as shown in Fig. 3B).
Regarding claim 10, Mismar discloses each of the at least three cavity portions has a rectangular shape with a radius around each corner (as shown in Fig. 3B).
Regarding claims 11 and 14, Mismar discloses a packaging (packaging 200 – shown in Figs. 3A-3C) capable of holding a syringe, the packaging comprising: a tray having an opening, a cavity including a plurality of cavity portions, a plurality of sidewalls, and a base (See Fig. 3A labeled above); wherein the plurality of cavity portions are connected to one another by intermediate narrowed portions (See Fig. 3A labeled above), each narrowed portion including a first sidewall (see Fig. 3A labeled above), a second sidewall (see Fig. 3A labeled above), a base (portion of the narrowed portion in which element 220 is disposed), wherein each of the first sidewall, the second sidewall, and the base, includes a geometric feature (at 210/220) extending away from the corresponding sidewall or base and projecting into the narrowed portion to position the syringe away from the plurality of sidewall; a lip (see Fig. 3A labeled above) surrounding the opening, wherein the lip extends radially outward from the cavity and defines a periphery of the tray; and a removable cover having a periphery that is adhered to the lip (described in [0041]), wherein the removable cover is permeable to a gaseous sterilant ([0041] describes the cover as being formed from Tyvek, which is well known in the art as being permeable to a gaseous sterilant, specifically ethylene oxide).
Regarding claim 12, Mismar discloses the geometric feature on the first sidewall is a first geometric feature (top-most element 210 in Fig. 3A) and the geometric feature on the second sidewall is a second geometric feature (bottom-most element 210 in Fig. 3A), and a distance between the first geometric feature and the second geometric feature ranges from about 5.5 mm to about 6.5 mm (based on the barrel diameters described in [0098]).
Regarding claim 13, Mismar discloses the plurality of cavity portions includes at least three cavity portions, and wherein a first cavity portion (see Fig. 3A labeled above) comprises a plunger rod of the syringe (left-most portion of syringe 10 in as shown in Fig. 3C), a second cavity portion (see Fig. 3A labeled above) comprises a barrel of the syringe (middle portion of syringe 10 as shown in Fig. 3C), and a third cavity portion (see Fig. 3A labeled above) comprises a needle attachment portion of the syringe (right-most portion of syringe 10 as shown in Fig. 3C)
Regarding claim 24, Mismar discloses the syringe is pre-filled with aflibercept (See [0102]).
Regarding claim 25, the packaging of Mismar is capable of holding a syringe pre-filled with aflibercept.
Regarding claim 32, Mismar discloses the syringe is a sterile syringe.
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 6 and 26-31 are rejected under 35 U.S.C. 103 as being unpatentable over Mismar et al. (US 2021/0077645) as applied to claim 1 above, in view of Lau (US 9,617,055).
Regarding claim 6, as described above, Mismar discloses the claimed invention except for the projection. However, Lau teaches a packaging (at 2 in Figs. 14A-14B) comprising a tray having a cavity (cavity between 126 and 68 in Fig. 14A) for holding an item (at 25) therein, wherein the bottom wall of the cavity includes a projection (at 130) in line with a portion of the item, for the purpose of assisting in ejecting the item from the tray (column 22, line 36 – column 23, line 13). 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 provided one of the cavity portions of the tray of Mismar with a projection as taught by Lau in order to assist in removing the syringe from the tray.
Regarding claim 26, Lau teaches the projection includes a dome shape (See Figs. 14A-14B and column 22, line 36 – column 23, line 13).
Regarding claim 27, Lau teaches a diameter of the projection defines a widest portion of the dome shape where the projection meets the base of the tray.
Regarding claim 28, Mismar-Lau discloses the projection is configurable to move relative to the syringe in response to receiving a pressure at a portion of the projection when pushing the projection.
Regarding claim 29, Lau teaches the projection includes a dome having a widest diameter at the base of the tray, wherein the projection extends directly outwards from the base such that the widest diameter of the dome is connected at the base.
Regarding claim 30, Mismar-Lau discloses the projection includes a dome and when the syringe is disposed within the cavity a height of the projection from an apex of the dome to a base of the dome is greater than a distance between the base of the dome and the portion of the syringe contained within the cavity and in line with the projection.
Regarding claim 31, Lau teaches the projection includes a dome shape that is hollow and open towards the cavity of the tray.
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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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