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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 21-24, 26-27, 29-37 and 41-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byrne (US 2006/0196193) (cited by applicant).
Byrne discloses a container (see Fig. 2) for use during an external sterilization process of a plurality of drug delivery devices (Byrne discloses vials), the container comprising: an outer housing (containment apparatus 10) including a plurality of openings (apertures 20) to permit and/or facilitate entry of sterilization gas into an inner volume thereof; and at least one partition (each wall strip 23 of the divider 21 is a partition) at least partially enclosed by the outer housing, wherein the at least one partition defines a plurality of chambers (compartments 25). Byrne fails to disclose the exact size of the chambers. Although, the Background of the Invention discloses use for storing vials and use suitable for a cryogenic freezer. Byrne fails to disclose that each chamber is configured to receive at least two of the plurality of drug delivery devices in a front to back configuration. A person having ordinary skill in the art understands that a storage container having chambers would necessitate the chambers being large enough to hold an item or items to be held therein and understands increasing or decreasing a chamber’s dimensions to accommodate an item or items to be placed within a chamber. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the chamber size to accommodate at least two drug delivery devices in a front to back configuration to provide sufficient space for the two drug delivery devices within any chamber to provide proper protection for the devices without damaging the devices in a chamber that is too small or confined.
Note that the drug delivery devices are not a positive claim limitation and that the claim limitation of chamber size is accommodate the devices is sought by applicant. Frezza (US 2009/0024095) discloses pre-filled syringes packaged within blister packs, see paragraphs [2], [3] and [7]. Hughes (US 5152394) discloses syringes 29 packaged in a coiled strip pack 31, see Fig. 3 and 4.
Re claim 22, the at least one partition includes a plurality of openings (apertures 22) to permit and/or facilitate distribution of the sterilization gas within the inner volume of the outer housing.
Re claim 23, the plurality of drug delivery devices each include a pre-filled syringe positioned within a blister pack. The size of the chamber is sized such that it accommodates devices, each include a pre-filled syringe positioned within a blister pack.
Re claim 24, the limitations or elements of the syringe would be accommodated by the chamber size.
Re claims 25-28, the limitations or elements of the blister pack would be accommodated by the chamber size.
Re claims 29-31, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the chamber size to accommodate at least three, four or five drug delivery devices in a front to back configuration to provide sufficient space for the drug delivery devices within any chamber to provide proper protection for the devices without damaging the devices in a chamber that is too small or confined.
Re claim 32, Byrne discusses and discloses adjustment of the size of the container in order to accommodate different quantity of devices, see paragraph [4] where 8x8, 9x9 and 10x10 packages are discussed and paragraph [9] where 12x16 and 6x10 packages are discussed. Byrne fails to specifically disclose that each of the at least one partitions is configured to receive at least 180 drug delivery devices. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify or adjust the container size and partition size to accommodate at least 180 drug delivery devices to accommodate a retail or customer need.
Re claim 33, the container includes at least two partitions (wall strips 23).
Re claim 34, the container of Byrne is not configured to receive at least 360 drug delivery devices. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify or adjust the container size and partition size to accommodate at least 360 drug delivery devices to accommodate a retail or customer need.
Re claim 35, the container includes at least four partitions (wall strips 23).
Re claim 36, the container of Byrne is not configured to receive at least 540 drug delivery devices. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify or adjust the container size and partition size to accommodate at least 540 drug delivery devices to accommodate a retail or customer need.
Re claim 37, the container of Byrne is not configured to receive at least 720 drug delivery devices. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify or adjust the container size and partition size to accommodate at least 720 drug delivery devices to accommodate a retail or customer need.
Claim(s) 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byrne in view of Williams (US 2003/0222129) (cited by applicant).
Re claims 38-40, Byrne discloses at least one partition positionable in an open configuration as shown in Fig. 2 wherein the chambers are configured to receive devices, the chamber defines a chamber volume of non-zero value. Byrne fails to disclose positioning the partition in a closed configuration. Williams teaches a partition (partitions 14, 15) with open configuration as shown in Fig. 1 and a closed configuration as shown in Fig. 4, the open configuration wherein the chambers are configured to receive devices, the chamber defines a chamber volume of non-zero value, the closed configuration wherein the chambers are substantially completely collapsed, the chamber volume is zero. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the partition to be a collapsible partition so that the partition conserves space in a collapsed position to make storage of the partition easier and less bulky.
Double Patenting
The obviousness double patenting rejections have been overcome by the addition of the last six lines to claim 21. Although the claims of Bitong et al. (US 12240652) discuss that the drug delivery device may be a syringe positioned within a blister pack and that two drug delivery devices may be received in a front to back configuration with each chamber. There is no discussion of the blister pack including a tray and a cover configured to seal the tray or that the cover of one of the plurality of drug delivery devices abutting the tray of an adjacent one of the plurality of drug delivery devices.
Response to Arguments
Applicant's arguments filed 6 April 2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the drug delivery devices have been positively claimed, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant states that the Office has not supported the rational for obviousness with facts. In the present case, the stated modification of increasing a size of the chambers to a size sufficient to receive and hold two drug delivery devices in front to back configuration should the size of the chamber be insufficient is based more on a common sense approach to a problem of insufficient space rather than, for example, supplying a missing element wherein there should at least be some evidence that the missing element is known.
Applicant notes the deficiency of Byrne because Byrne fails to state the specific use of accommodating two drug delivery devices in front to back configuration. There is no requirement that a primary reference must indicate the intended motivation for an obviousness rejection
Conclusion
THIS ACTION IS MADE FINAL. 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.
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sjc/STEPHEN J CASTELLANO/ Primary Examiner, Art Unit 3733
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