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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/4/2026 has been entered.
This Office Action acknowledges the applicant’s amendment filed on 3/4/2026. Claims 1-4 and 6-7 are pending in the application. Claim 5 is 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 Claims 4 and 7 are withdrawn from consideration.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, 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 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.
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 “non-hollow” solid portion of the retaining tool must be shown or the feature(s) canceled from the claim(s). 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 § 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 1-3 and 6 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.
The specification does not describe the limitation “non-hollow” solid portion, therefore, it is unclear what is considered “non-hollow”, whether it is a specific type of material, a portion that has no opening or spacing or something else. The specification has not shown or described what the inside of the retaining tool or solid portion looks like to determine what “non-hollow” means or consist of. Additionally, with respect to the latter limitation it is noted that this is a negative limitation introduced for the first time in an amendment. The specification does not teach the feature in such a way that applicant can now affirmatively claim it as applicants invention. Thus, in addition to the lack of specification description, as noted above, the negative limitation is also considered to constitute New Matter.
The specification does not specifically describe the limitation “the recessed portion is a blind hole”. The specification recites on pg. 11 of the instant application that 317/318 are recesses, however, it does not recite the recesses are “blind holes”. It is understood in the art that “blind holes” are considered a specific type of recess that is drilled or machined to a predetermined specification and does not pass completely through the material and usually require precise depth control, whereas other recesses may not have such strict requirements. In the instant specification, it recites the recesses are not required as longs as the viscous material is maintained at a predetermined temperature, leading to assume the recesses are not as critical as a blind hole would be.
Claims 2-3 and 6 are rejected due to their dependency on claim 1.
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 1-3 and 6 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.
Claims 1-3 recite the limitation “non-hollow” solid portion. It is unclear how to interpret this limitation because the instant specification does not describe what is meant by “non-hollow”. It is not known whether it is a specific type of material, a portion that has no opening or spacing or something else. For examination purposes, it will be assumed, “non-hollow” refers to the material and the surface of the solid portion surrounding the insertion portions.
Claim 1 recites the limitation “the recessed portion is a blind hole”. It is unclear how to interpret this limitation because the instant specification does not describe what is meant by “blind hole”. For examination purposes, it will be assumed “blind hole” is just further defining the recess.
Claims 2-3 and 6 are rejected due to their dependency on claim 1.
Claim Rejections - 35 USC § 103
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 Xiaohai et al. US 2005/0189404 A1 and further in view of Sixt US 2007/0210090 A1, all previously cited.
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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 non-hollow 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 non-hollow 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 the non-hollow solid portion of the retaining tool includes a 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 a non-crosslinked foamed polyethylene. (Para. 0004, 0020, 0065 and 0071)
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, and the content storage container has a surface having a recessed portion, and the recessed portion is a blind hole.
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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), and the content storage container has a surface having a recessed portion, and the recessed portion is a blind hole (recessed portion extending from the bottom and stopping before the opening; shown above).
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 2, Denton discloses the non-hollow solid portion (12/foam) is formed in a layer shape in the insertion direction.
With regards to claim 3, Denton discloses the non-hollow 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
Applicant's arguments filed 3/4/2026 have been fully considered but they are not persuasive. The Applicant argues Denton does not disclose a retaining tool with a “non-hollow” solid portion. The Applicant also recites “The term "solid" means "being without an internal cavity" (https://www.merriam- webster.com/dictionary/solid)”, the Examiner respectfully disagrees. As stated above, the term “non-hollow” solid portion was not previously recited in the original specification. Although, the Applicant cites in the instant application PG Pub. para. 0067, the inside of the retaining tool is solid, the specification does not provide any further details features or drawings to provide any more information regarding what is meant by “solid”. It is not known if the retaining tool is formed as one piece of solid material, if solid means the container is filled to form a solid portion or something else. Denton forms non-hollow solid material around the insertion portion and is filled with foam, therefore, it is considered a non-hollow solid portion.
The Applicant also argues Denton and the secondary reference Sixt does not disclose “the content storage container has a surface having a recessed portion, and the recessed portion is a blind hole”. As stated above, the specification does not specifically disclose the recessed portions are a blind hole. However, the Examiner respectfully disagrees. Sixt teaches that it is known in the art to have a content container have a recess that is a blind hold (the recess extends from the bottom and extend to and stops short of the opening, it does not extend into the container; shown 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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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.
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/JENINE SPICER/Examiner, Art Unit 3736
/ORLANDO E AVILES/Supervisory Patent Examiner, Art Unit 3736