DETAILED ACTION
The Office acknowledges receipt of the Applicant’s response and amendments filed 22 April 2026.
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 § 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.
Claim 11 is 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.
Regarding claim 11, the claim recites, “wherein the device removal facilitation mechanism includes a groove extending along a length of the body of the tray”. However, the “groove” is deemed to have been already introduced in claim 10.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-5, 7, 10-12 and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hurst (US 2016/0015457 A1).
Regarding claim 1, Hurst discloses an intermediate bulk shipping container including:
a box (13; fig. 10) having an interior cavity;
at least one tray (10) including a body (24) defining a plurality of recesses (36), each of the plurality of recesses dimensioned to accommodate a drug delivery device (12), the body (24) further defining at least one sidewall (38) at least partially surrounding each of the plurality of recesses (36; paragraph 0056 – “channels (36) extend from the border region (40) on one side of body (24) to the border region (40) on an opposing side of body (24)... For the preferred embodiment, the hollow ridges (38) define at least one ridge gap (42, FIG. 5). For the exemplary embodiment depicted in FIG. 1 and as best seen in FIG. 5, for example, each hollow ridge (38) defines four ridge gaps (42).”), and a device removal facilitation mechanism (42; paragraph 0057 – “Another purpose is to provide an access point to barrel portion (14), for example, for easy removal of a syringe system being stored in storage apparatus (10)”) including a groove (any of 42; figs. 5-6) extending through each sidewall between the plurality of recesses (fig. 5; sidewalls 38 extend from border region 40 on one side of body 24 to border region 40 on the opposing side as seen in fig. 5. Grooves 42 extend between a center portion of each of these defined sidewalls 38);
wherein the body of the at least one tray defines more than four recesses (36; figs. 1-2).
Regarding claim 2, Hurst discloses wherein the at least one tray (10) includes a positioning notch (34r; paragraph 0049) formed on the body (24).
Regarding claim 3, Hurst discloses wherein the at least one tray comprises a plurality of trays, wherein each of the plurality trays is stackable such that the plurality of trays are disposable within the interior cavity of the box (paragraphs 0049, 0052, 0064-0065; figs. 10 and 16).
Regarding claim 4, Hurst discloses a lid (9; fig. 18) adapted to cover the at least one tray (paragraphs 0085-0088).
Regarding claim 5, Hurst discloses wherein the lid includes a lid positioning notch (34a; fig. 18; paragraph 0085).
Regarding claim 7, Hurst a method of processing a plurality of drug delivery devices (12) comprising:
completing a first process step in which the plurality of drug delivery devices (12) are at least partially assembled (paragraph 0047 – “prefilled syringes”);
completing an intermediate process step (paragraph 0003 – “such syringe storage trays should be stackable so that they can sit on top of one another where the syringes of a lower tray remain untouched by an upper tray.” Stacking the trays is deemed to be an intermediate process step) using an intermediate bulk shipping container including: a box (13; fig. 10) having an interior cavity and at least one tray (10) including a body (24) defining a plurality of recesses (36), each of the plurality of recesses dimensioned to accommodate a drug delivery device (paragraphs 0066, 0083; figs. 1-3), the body (24) further defining at least one sidewall (38) at least partially surrounding each of the plurality of recesses (36; paragraph 0056 – “channels (36) extend from the border region (40) on one side of body (24) to the border region (40) on an opposing side of body (24)... For the preferred embodiment, the hollow ridges (38) define at least one ridge gap (42, FIG. 5). For the exemplary embodiment depicted in FIG. 1 and as best seen in FIG. 5, for example, each hollow ridge (38) defines four ridge gaps (42).”), and a device removal facilitation mechanism (42; paragraph 0057 – “Another purpose is to provide an access point to barrel portion (14), for example, for easy removal of a syringe system being stored in storage apparatus (10)”) including a groove (any of 42; figs. 5-6) extending through each sidewall between the plurality of recesses (fig. 5; sidewalls 38 extend from border region 40 on one side of body 24 to border region 40 on the opposing side as seen in fig. 5. Grooves 42 extend between a center portion of each of these defined sidewalls 38), wherein the body of the at least one tray defines more than four recesses (figs. 1-3); and
completing a subsequent process step in which the plurality of drug delivery devices are prepared for administration (paragraph 0057 – “easy removal of a syringe system”).
Regarding claim 10, Hurst discloses a drug processing system comprising:
at least one tray (10) including:
a body (24) defining a plurality of recesses (36; paragraph 0056 – “channels (36) extend from the border region (40) on one side of body (24) to the border region (40) on an opposing side of body (24)... For the preferred embodiment, the hollow ridges (38) define at least one ridge gap (42, FIG. 5). For the exemplary embodiment depicted in FIG. 1 and as best seen in FIG. 5, for example, each hollow ridge (38) defines four ridge gaps (42).”), each of the plurality of recesses dimensioned to accommodate a drug delivery device (12), the body further defining at least one sidewall (center section #38 as seen in fig. 5) at least partially surrounding each of the plurality of recesses, and
a device removal facilitation mechanism (42; paragraph 0057 – “Another purpose is to provide an access point to barrel portion (14), for example, for easy removal of a syringe system being stored in storage apparatus (10)”) including a groove (any of 42; figs. 5-6) extending through each sidewall between the plurality of recesses (fig. 5; sidewalls 38 extend from border region 40 on one side of body 24 to border region 40 on the opposing side as seen in fig. 5. Grooves 42 extend between a center portion of each of these defined sidewalls 38),
wherein the body (24) of the at least one tray defines more than four recesses (36; figs. 1-2).
Regarding claim 11, Hurst discloses wherein the device removal facilitation mechanism (42; paragraphs 0056-0057; figs. 5-6) includes a groove (42) extending along a length of the body of the tray (figs. 5-6).
Regarding claim 12, Hurst discloses comprising an orientation mechanism (end portions of #38 near #40 in fig. 5) disposed in or near each of the plurality of recesses (36), the orientation mechanism adapted to orient each of the drug delivery devices in a first position (fig. 3).
Regarding claim 18, Hurst discloses a positioning notch (34r; paragraph 0049) formed on the body (24).
Regarding claim 19, Hurst discloses wherein the at least one tray (10) is reusable (paragraph 0046 – “any suitable material may be used wherein such material preferably allows for the use of common sterilization processes and provides for a crushproof structural integrity”; The invention of Hurst is deemed to be “reusable” since it is made of a material that is able to be sterilized, thus making it suitable for use again, and “crushproof” thus making it durable enough for reuse).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hurst (US 2016/0015457 A1) in view of Lacy, III (US Patent 5,779,055) hereinafter referred to as Lacy.
Regarding claim 6, Hurst discloses wherein the at least one tray is constructed from an anti-static material (paragraphs 0046, 0053).
Wherein the Applicant may argue that Hurst does not disclose being constructed from an anti-static material, Lacy further teaches at least one tray (510) is constructed from an anti-static material (col. 5 line 56 – col. 6 line 3).
Given the teachings of Lacy, it would have been obvious to one of ordinary skill in the art before the time of effective filing to construct the tray of Hurst with the anti-static material of Lacy. Both are concerned with packaging sensitive products to be protected from outside environments. Having anti-static features would help to further protect products from outside factors like dust and debris.
Claim(s) 8 and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hurst (US 2016/0015457 A1) in view of Goetzelmann (US Patent 5,934,859).
Regarding claim 8, Hurst does not disclose wherein the intermediate process step includes transporting the plurality of drug delivery devices to a secondary location.
However, Goetzelmann teaches wherein the intermediate process step includes transporting the plurality of drug delivery devices (2) to a secondary location (col. 4 lines 42-45).
Given the teachings of Goetzelmann, it would have been obvious to one of ordinary skill in the art before the time of effective filing to have the intermediate process step of Hurst include transporting the plurality of drug delivery devices to a secondary location. Doing so was well-known in the art as drugs are often needed to be transported to locations where they can be stored for future need or otherwise place them in a location that will be more accessible to end users.
Regarding claim 14, Hurst does not disclose an arm positioned above the at least one tray, the arm including a grasping mechanism adapted to remove each of the drug delivery devices disposed within the plurality of recesses in a continuous motion.
However, Goetzelmann teaches an arm (21, 20) positioned above (figs. 4-5 and 9) the at least one tray (1; 53), the arm including a grasping mechanism (24, 28) adapted to remove each of the drug delivery devices (2) disposed within the plurality of recesses in a continuous motion (col. 4 line 16 – col. 5 line 20).
Given the teachings of Goetzelmann, it would have been obvious to one of ordinary skill in the art before the time of effective filing to modify the invention of Hurst to include the arm and grasping mechanism of Goetzelmann. Hurst is already concerned about the removal of the drug delivery devices from the tray and Goetzelmann teaches an automated way of doing so that would reduce the need for human labor.
Regarding claim 15, Hurst as modified by Goetzelmann above discloses a platform (Goetzelmann - 40; fig. 6 – see at least support plate for 40) adapted to support the at least one tray.
Given the teachings of Goetzelmann, it would have been obvious to one of ordinary skill in the art before the time of effective filing to modify the invention of Hurst to include the arm and grasping mechanism and platform of Goetzelmann. Hurst is already concerned about the removal and placement of the drug delivery devices and trays and Goetzelmann teaches an automated way of doing so that would reduce the need for human labor.
Regarding claim 16, Hurst as modified by Goetzelmann above discloses wherein the platform (Goetzelmann - 40) is further adapted to transport the at least one tray to a subsequent processing station (Goetzelmann - col. 4 lines 42-45).
Given the teachings of Goetzelmann, it would have been obvious to one of ordinary skill in the art before the time of effective filing to have the Hurst include a means for transporting the plurality of drug delivery devices to a secondary location. Doing so was well-known in the art as drugs are often needed to be transported to locations where they can be stored for future need or otherwise place them in a location that will be more accessible to end users.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hurst (US 2016/0015457 A1) in view of Stefan et al. (US 12,440,616 B2) hereinafter referred to as Stefan.
Regarding claim 9, Hurst fails to disclose the subsequent process step includes at least one of applying at least one label to each of the plurality of drug delivery devices or repackaging at least one of the drug delivery devices into an end-user container.
However, Stefan teaches the subsequent process step includes at least one of applying at least one label (col. 2 lines 42-49) to each of the plurality of drug delivery devices or repackaging at least one of the drug delivery devices into an end-user container.
Given the teachings of Stefan, it would have been obvious to one of ordinary skill in the art before the time of effective filing to modify the step of Hurst to include applying labels as in Stefan. Applying labels is notoriously well-known in the art and serves to individually identify drug delivery devices for particular patients so as to keep an accurate record of administered medications.
Additionally, the Office further took official notice in the Office Action of 29 January 2026 that it would have been obvious to one of ordinary skill in the art before the time of effective filing to have the subsequent process step of Hurst include repackaging at least one of the drug delivery devices into an end-user container. Doing so was notoriously well-known in the art. Hurst already discloses removing the drug delivery device from the tray. Subsequently placing the delivery device into a container while it is waiting to be administered to an individual end user is considered generally good practice as it protects the delivery device from damage until it is ready to be used and can allow for safer transport to the end-user during administration. The common knowledge or well-known in the art statement is taken to be admitted prior art because applicant failed to traverse the examiner’s assertion of official notice (MPEP 2144.03 C).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hurst (US 2016/0015457 A1) in view of Higgins et al. (US Patent 3,305,084) hereinafter referred to as Higgins.
Regarding claim 13, Hurst discloses wherein the orientation mechanism includes an undercut portion (end portions of #38 near #40 in fig. 5 is down into the tray and deemed to be an undercut portion).
Wherein the Applicant may argue that Hurst does not disclose an undercut portion, the Office alternatively points to Higgins which teaches wherein the orientation mechanism (fig. 4; #11, 11a,b, 17b and 19) includes an undercut portion (19).
Given the teachings of Higgins, it would have been obvious to one of ordinary skill in the art before the time of effective filing to modify the orientation mechanism of Hurst to include an undercut portion as in Higgins. Doing so would allow the device to be more easily removed from the recess by allowing room to tilt and/or easier grasping.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hurst (US 2016/0015457 A1) in view of Farrar et al. (US 2010/0012537 A1) hereinafter referred to as Farrar in further view of Glithero et al. (US 2016/0228676 A1) hereinafter referred to as Glithero.
Regarding claim 17, Hurst fails to disclose a visual identifier disposed within each of the plurality of recesses.
However, Farrar teaches a visual identifier (fig. 4a; paragraphs 0005 and 0041) disposed with each of the plurality of recesses (13).
Given the teachings of Farrar, it would have been obvious to one of ordinary skill in the art before the time of effective filing to modify the invention of Hurst to include the visual identifiers for each of the recesses as in Farrar. Doing so would help a user to see how many doses remained of a medication or could make sure that particular doses were given to particular clients.
Wherein, Hurst as modified by Farrar does not disclose the visual identifier located within the recess, the Office further points to Glithero.
Glithero teaches wherein the visual identifiers (47, 48, 49, 50) are located within the recesses (figs. 1 and 27).
Given the teachings of Glithero, it would have been obvious to one of ordinary skill in the art before the time of effective filing to modify the invention of Hurst as modified by Farrar to have the visual indicators located within the recesses. Doing so would more directly label the specific drug delivery devices by having the recess they were located in directly labeled itself.
Response to Arguments
Applicant's arguments filed 22 April 2026 have been fully considered but they are not persuasive.
Applicant’s arguments rely on amendments to the claim limitations which are still deemed to be read on by Hurst as detailed in the Office Action above. The Applicant argues that the gaps (42) of Hurst cannot be consider the currently claimed “groove extending through each sidewall between the recess”. To this the Applicant tries to argue that the gaps are “interruptions in the ridges, not continuous grooves that pass through the sidewalls”.
The Office contends that this argument is wordplay which puts forward a distinction in synonyms without a difference in realized structure. The Applicant’s disclosed groove is element 118 best seen in figs. 2 and 3. This element could also be described in the same terms as an “interruption in the ridges” of sidewalls 116.
Regarding Hurst, the Office contends that the disclosed sidewalls 38, which are noted as extending from side to side of the body (see paragraph 0056), have a gap 42 (understood to also constitute a groove) which extends through each of those sidewalls as claimed (best seen in figs. 5-6) in the same manner as the Applicant’s invention. The Applicant argues that the cited groove 42 is “not continuous”, but this language is not in the claim and even if it was, the groove 42 is clearly shown as continuously extending along the length of the body between the sidewalls. The Applicant’s argues the groove 42 is not to facilitate removal of the devices, but this is also not true as clearly disclosed in paragraph 0057 of Hurst. The Applicant ties to argue that Hurst does not allow for the type of removal their invention allows for, but this is not claimed, and even if it was, the Office deems Hurst to be capable of the “cascading and/or swiping” removal alluded to in the arguments because the grooves 42 run the length of the body as seen in figs. 5-6. The grooves 42 of Hurst are immediately recognizable as equivalent structures, in both form and function, to the claimed groove of the instant invention.
Furthermore, the “hollow ridge” (38) of Hurst is also immediately recognizable as a sidewall structure of the Applicant’s disclosed invention. The hollow ridges (38) of Hurst extend upward and form a clear wall as best seen in fig. 3. This is an equivalent structure to the Applicant’s sidewall 116 seen in Applicant’s fig. 3.
Applicant’s remaining arguments rely on arguments directed toward the independent claims which are not persuasive for the reasons provided above and as detailed in the rejection of record.
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 ANDREW M TECCO whose telephone number is (571)270-3694. The examiner can normally be reached M-F 11a-7p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached at (571) 270-1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW M TECCO/ Primary Examiner, Art Unit 3731
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