DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 15 July 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 7, the claim recites, “the body further defining at least one sidewall at least partially surrounding each of the plurality of recesses and extending a length below each of the plurality of recesses”.
The claim is written such that it reads that the sidewall extends a length below each of the recesses. However, this feature was not disclosed in the original specification and is therefore deemed to constitute new matter. The Office deems this limitation to be a result of a typographical error and for the purposes of examination, this limitation is being treated that the device removal facilitation mechanism in the form of a groove extends a length below the recess as recited in paragraph 0028 of the Applicant’s original Specification.
Regarding claims 8-9, each of these claims are dependent on claim 7 and therefor require the same new matter as the parent claim.
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 7-9 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.
Regarding claim 7, the claim recites, “the body further defining at least one sidewall at least partially surrounding each of the plurality of recesses and extending a length below each of the plurality of recesses”.
The claim is written such that it reads that the sidewall extends a length below each of the recesses. However, given that the sidewall defines the recess, it is not clear how it would extend below it. The Office deems this limitation to be a result of a typographical error and for the purposes of examination, this limitation is being treated that the device removal facilitation mechanism in the form of a groove extends a length below the recess as recited in paragraph 0028 of the Applicant’s original Specification.
Regarding claims 8-9, each of these claims are dependent on claim 7 and therefor require the indefinite subject matter as the parent claim.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “groove (118) extending a length below each of the plurality of recesses (114)” (claims 1, 7 (as interpreted) and 10) must be shown or the feature(s) canceled from the claim(s). While this feature is discussed in paragraph 0028 of the original Specification as an option, it is not deemed to be shown in the drawings.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) and extending a length below each of the plurality of recesses (fig. 6 - The center portion of grooves 42 are shown to be below the bottom level of recesses 36. Paragraph 0027 denotes that the view seen in fig. 6 and shows that this low position of the groove extends along the length of the groove depicted in fig. 5);
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 extending a length below each of the plurality of recesses (See 35 USC 112a/b rejections above. The claim is written such that it reads that the sidewall extends a length below each of the recesses. However, this feature was not disclosed in the original specification and given that the sidewall defines the recess, it is not clear how it would extend below it. For the purposes of examination, this limitation is being treated that the device removal facilitation mechanism in the form of a groove extends a length below the recess as recited in paragraph 0028 of the Applicant’s original Specification. This limitation is deemed to be disclosed by Hurst in fig. 6 which shows the center portion of grooves 42 to be below the bottom level of recesses 36. Paragraph 0027 denotes that the view seen in fig. 6 and shows that this low position of the groove extends along the length of the groove depicted in fig. 5), 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) and extending a length below each of the plurality of recesses (fig. 6 - The center portion of grooves 42 are shown to be below the bottom level of recesses 36. Paragraph 0027 denotes that the view seen in fig. 6 and shows that this low position of the groove extends along the length of the groove depicted in fig. 5),
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 15 July 2026 have been fully considered but they are not persuasive.
Applicant’s arguments appear to rely on an interpretation of the Hurst reference that the Office is not utilizing or is otherwise reading Hurst in a fashion that eludes the Examiner. The Applicant argues that “The Hurst reference therefore has no groove extending a length below the recess.” The Office deems this limitation to be clearly shown in figs. 5-6 and will annotate such below for further clarification. The grooves 42 are deemed to be clearly shown as being below the bottom surface of recesses 36.
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The remainder of the Applicant’s arguments rely on arguments directed toward the independent claim and therefore those respective rejections are maintained.
Conclusion
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.
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, 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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