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 .
This Office Action acknowledges the applicant’s amendment filed on 6/3/2026. Claims 1, 3-4 and 6-7 are pending in the application. Claims 2 and 5 are cancelled. Claims 4 and 7 are withdrawn from consideration.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, 3 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 4, 6 and 8 of copending Application No. 18/552520 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 retaining tool (packing member ‘520) including an insertion portion to store syringes in a standing (upright) position and a solid portion surrounding the insertion portion, the solid portion is formed in a layer shape by sequentially providing a plurality of layers of the non-crosslinked foamed polyethylene in the insertion direction, 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 between the co-pending applications is the present application recites additional features and limitations, such as, the surrounding member is disposed between the tool and each of the side walls of the packing container and the surrounding member includes the buffer member.
However, Fine (Fig. 2) teaches that it was known in the art to have a syringe transport tool have a packing container 1 with side walls with the surrounding member 3 disposed between the tool 2 and each of the side walls of the packing container and the surrounding member 3 includes the buffer member. (Col 5:28-34)
It would be obvious to one having ordinary skill in the art to have the surrounding member arranged around the packing container and include the buffer member as taught by Fine since doing so would provide more insulation and protection to the articles in the package.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1, 3 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Denton et al. US 5,850,917, in view of Martin US 2002/01955575 A1 in view of Xiaohai et al. US 2005/0189404 A1 and further in view of Sixt US 2007/0210090 A1, all previously cited.
PNG
media_image1.png
363
536
media_image1.png
Greyscale
With regards to claim 1, Denton discloses syringe transport tool set comprising:
a retaining tool 10 comprising: an insertion portion (at 16) allows insertion of a syringe including a material storage container that houses a viscous material in a state where the syringe is in a vertically standing position erected (depending on the syringe to be inserted); and a solid portion (12 and foam described in Col 3:40-65) that is provided around the insertion portion and forms the insertion portion; wherein 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 an opposite side of the first end portion in an insertion direction in which the viscous material is inserted into the insertion portion, and contains a foam.
Denton discloses Col 3:40-65, recites the solid portion 12, includes a plurality of materials including foam but it does not specifically disclose the solid portion is formed in a layer shape by sequentially providing a plurality of layers of the non-crosslinked foamed polyethylene in the insertion direction.
PNG
media_image2.png
474
455
media_image2.png
Greyscale
However, Martin (Fig. 5) teaches that it was known in the art to have a solid portion formed in a layer shape by sequentially providing a plurality of layers 50 of foamed polyethylene in the insertion direction (for a syringe).
Denton discloses the solid portion of the retaining tool includes foam, but it does not specifically disclose it contains non-crosslinked foamed polyethylene.
Xiaohai teaches that it was known in the art to have a retaining tool that holds temperature sensitive articles such as medical or pharmaceutical products and includes layers of a non-crosslinked foamed polyethylene. (7/9/11/13/15 Para. 0004, 0020, 0063, 0065, 0071 and claim 4)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select a known material based on its suitability for its intended purpose, per MPEP 2144.07, since Xiaohai teaches the use of that type of material (non-crosslinked foamed polyethylene) to hold articles with temperature sensitivity.
Denton discloses the device can be used to transport temperature sensitive article such as syringes but it does not specifically disclose a packing container having a housing space, wherein the packing container has side walls; the retaining tool installed in the housing space of the packing container; a surrounding member that is disposed between the retaining tool and each of the side walls of the packing container; and a cold storage agent that is installed between the retaining tool and the surrounding member in the housing space of the packing container and includes a content that refrigerates the syringe and a content storage container that houses the content the surrounding member includes a buffer member that mitigates an external force applied to the syringe when the syringe is transported, the buffer member has a thermal conductivity of 0.022 W/m.K or less, and the content is configured to have a melting point of -30 degrees or less.
PNG
media_image3.png
369
332
media_image3.png
Greyscale
PNG
media_image4.png
233
354
media_image4.png
Greyscale
However, Sixt (Fig. 1and 4) teaches it was known in the art to have a packing container 1 having a housing space, wherein the packing container has side walls 9/12; a surrounding member 6 that is disposed between the retaining tool 2 and each of the side walls of the packing container; and a cold storage agent 3/4 (shown in Fig. 4) that is installed between the retaining tool and the surrounding member in the housing space of the packing container and includes a content 24’ that refrigerates the syringe and a content storage container 24 that houses the content; the surrounding member includes a buffer member (Para. 0030-0031) that mitigates an external force applied to the syringe when the syringe is transported, the buffer member has a thermal conductivity of 0.022 W/m.K or less (Para. 0031), and the content is configured to have a melting point of -30 degrees or less (Abstract, Para. 0007).
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 transport container in Denton by having the content have a melting point of -30 degrees or less and installed the insert portion in the housing space of the packing container as taught by Sixt for the purposes of keeping the sensitive articles cooler longer and prevent damage to the articles.
With regards to claim 3, Denton discloses the solid portion (12/foam) is provided with a flat surface at the second end portion.
With regards to claim 6, Sixt (Fig. 4) further teaches the content storage container 24 has a flat surface.
Response to Arguments
Applicants’ arguments with respect to claim(s) 1, 3 and 6 have been considered but are moot because of a new ground of rejection. However, with regards to the Applicants’ remarks that Denton does not disclose the amended limitation “the solid portion is formed in a layer shape by sequentially providing a plurality of layers of the non-crosslinked foamed polyethylene in the insertion direction”. Martin has been cited to teach that it was known in the art to have a solid portion including a plurality of layers of the foamed polyethylene (50, para. 0028)in the insertion direction (for a syringe). Additionally, Xiaohai teaches it was known in the art to have a plurality of layers of non-crosslinked foamed polyethylene (7/9/11/13/15, para. 0063).
Conclusion
Applicants’ 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 JENINE SPICER whose telephone number is (313)446-4924. The examiner can normally be reached 9:00am-5:00pm, Monday-Thursday.
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, Orlando E. Avilés can be reached at (571) 270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JENINE SPICER/ Examiner, Art Unit 3736
/RAFAEL A ORTIZ/ Primary Examiner, Art Unit 3736
Prosecution Insights