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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/26/2026 has been entered.
This Office Action acknowledges the applicant’s amendment filed on 2/26/2026. Claims 1-8 are pending in the application. Claims 8 is new. Claims 3 and 7 are withdrawn from consideration.
The text of those sections of Title 35, U.S. code not included in this action can be found in a prior Office Action.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5-6 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6 of co-pending Application No. 18/552528 in view of Fine et al. US 6,070,427.
Although the claims at issue are not identical, they are not patentably distinct from each other because each set of claims recite a syringe transport tool set comprising a packing container having side walls, a packing member (retaining tool ‘528) including an insertion portion to store syringes in a standing (upright) position and a solid portion surrounding the insertion portion, a cold storage agent to refrigerate the syringe and a content storage container that houses the content and a surrounding member (buffer member).
The difference of the co-pending applications is the present application recites additional features and limitations, such as, the packaging member that is installed in a housing space of a packing container, surrounds a syringe (being positively claimed) including a material storage container that houses a viscous material.
However, Fine (Fig. 2) teaches that it was known in the art to have a syringe transport tool having a packaging member 1 that is installed in a housing space of a packing container, surrounds a syringe (being positively claimed) including a material storage container that houses a viscous material. (Col 5:28-49)
It would be obvious to one having ordinary skill in the art to have the packaging member surround a syringe as taught by Fine since doing so would provide more cooling and protection to the articles in the package.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 103
Claim(s) 1-2, 4-6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douglas-Hamilton US 2003/0084680 A1 in view of Sixt et al. US 2007/0210090 A1, in view of Xiaohai et al. US 2005/0189404 A1, all previously presented.
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With regards to claim 1, Douglas-Hamilton discloses a syringe transport tool set 10 comprising: a packaging member 18 that is installed in a housing space of a packing container, surrounds a syringe 22 including a material storage container that houses a viscous material; a buffer member (Styrofoam walls of box 12; Para. 0023) that mitigates an external force applied to the syringe transport tool set when the syringe is transported; and a cold storage agent 16 that is installable between the packaging member and the buffer member in the housing space and includes a content that refrigerates the syringe and a content storage container that houses the content, the packaging member includes an insertion portion that allows insertion of the syringe in a state where the syringe is in a vertically standing position (when the container is positioned on its side, considered the bottom; shown above) when the syringe transport tool set is positioned on its bottom, and a solid portion that is provided around the insertion portion and forms the insertion portion, and the solid portion is formed from a first end portion on a side where the insertion portion is located to a second end portion on a side opposite to the first end portion in an insertion direction in which the viscous material is inserted into the insertion portion (see annotated drawing above).
Douglas-Hamilton discloses a content (16: cooling pack) that refrigerates the syringe and a melting point for the content but it does not specifically disclose a content storage container that houses the content and the content is configured to have melting point in a range of -50 degrees or more to -30 degrees or less; and the content storage container that has a surface on which a recessed portion is formed.
Sixt teaches that it was known in the art to have a container that holds and transports temperature sensitive medical articles that includes content 24’ that refrigerates the articles, a content storage container 24 that houses the content and the content is configured to have a melting point of melting point in a range of -50 degrees or more to -30 degrees or less; and the content storage container has a surface on which a recessed portion (at 25) is formed. (Abstract, Para. 0006-0007, 0054 and claim 30 and Fig. 4; annotated below)
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Douglas-Hamilton discloses a buffer (foam insulation) to provide protection and insulation to the syringes but it does not specifically disclose the buffer member has a thermal conductivity of 0.022 W/m-K or less.
Sixt (Fig. 1) teaches that it was known in the art to have a buffer member 6 have a thermal conductivity of 0.022 W/m-K or less. (Para. 0006, 0031 and claims 30-31)
The inventions of Douglas-Hamilton and Sixt are both drawn to the field of containers that are capable of holding temperature sensitive articles. Each container includes a buffer and a content to refrigerate the sensitive articles. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the content and buffer in Douglas-Hamilton by providing a content storage container that houses the content and the content is configured to have a melting point in a range of -50 degrees or more to -30 degrees or less and the buffer member have a thermal conductivity of 0.022 W/m-K or less as taught by Sixt for the purposes of providing a cooler temperature to the articles for longer storage or transporting time, depending on the articles to be transported.
Douglas-Hamilton discloses the solid portion is made of foam (Para. 0025) but it does not specifically disclose it is solid portion contains non-crosslinked foamed polyethylene.
However, Xiaohai teaches that it was known in the art to have a container that holds and transports temperature sensitive medical articles that includes a packaging member that forms a solid portion that contains non-crosslinked foamed polyethylene. (Para. 0020 and 0063-0065)
The inventions of Douglas-Hamilton and Xiaohai are both drawn to the field of containers that are capable of holding temperature sensitive articles. Each container includes a packaging member to assist in the thermal insulation of the articles. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the packaging member in Douglas-Hamilton by having the member contain non-crosslinked foamed polyethylene as taught by Xiaohai for the purposes of providing more formable material.
Douglas-Hamilton discloses a content (16: cooling pack) that refrigerates the syringe its content but it does not specifically disclose the content storage container that has a surface on which a recessed portion is formed.
With regards to claim 2, Sixt discloses the content storage container 24 has a flat surface. (shown in the annotated figure above)
With regards to claim 4, Douglas-Hamilton does not specifically disclose the non-crosslinked foamed polyethylene contained in the solid portion has a linear expansion coefficient of 0.1 to 10 x 10-4 cm/cm· °C.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the solid portion have a linear expansion coefficient of 0.1 to 10 x 10-4 cm/cm· °C, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With regards to claim 5, Douglas-Hamilton the solid portion (shown above) is formed in a layer shape (single layer) in the insertion direction.
With regards to claim 6, Douglas-Hamilton the solid portion (shown above) is provided with a flat surface at the second end portion.
With regards to claim 8, Sixt further teaches one or more other recessed portions (recessed portion below and next to recess 25; shown in the annotated figure above) are formed on the surface of the content storage container.
Response to Arguments
Applicant's arguments filed 2/26/2026 have been fully considered but they are not persuasive. The Applicant argues Douglas-Hamilton does not disclose the limitation “the packaging member includes an insertion portion that allows insertion of the syringe in a state where the syringe is in a vertically standing position when the syringe transport tool set is positioned on its bottom”, the Examiner respectfully disagrees. As shown above, in the annotated drawing, the Examiner considers that particular side of the syringe transport tool set to be the bottom, therefore, in that position, the packaging member 18 allows insertion of the syringe in a state where the syringe is in a vertically standing position.
The Applicant also argues that Douglas-Hamilton or the secondary references disclose a recessed portion on its surface of the content container, the Examiner respectfully disagrees. As stated above, Sixt teaches that it is was known in the art to have a content container 24 that includes a recessed portion 25 and also another recessed area below 25 (shown in the annotated drawing above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENINE SPICER whose telephone number is (313)446-4924. The examiner can normally be reached 9:00am-5:00pm, Monday-Thursday.
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/JENINE SPICER/Examiner, Art Unit 3736
/ORLANDO E AVILES/Supervisory Patent Examiner, Art Unit 3736