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 12/10/2025. Claims 110, 112-115, 118-121 and 126-136 are pending in the application. Claims 1-109, 111, 116-117 and 122-125 are cancelled. Claims 135-136 are new. Claims 126-129 are withdrawn from consideration.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.
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.
Claim 135 is 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 specifically recite the limitation “the plurality of vials comprises exactly 169 or 188 vials”. The specification gives round about figures for the amount of vials to be held in the tray but it does not provide an exact amount of 169 or 188.
Claim Rejections - 35 USC § 103
Claim(s) 110, 112, 118 and 133 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lantz US 2006/0174648 A1 in view of Tomes et al. US 2016/0166800 A1.
With regards to claim 110, Lantz (Fig. 2) discloses a container system comprising: a) a primary container 10; b) a payload container 30/32; c) at least one tray 40; and d) a dry ice container 42; wherein the payload container is placed at the bottom of the primary container, wherein the dry ice container is disposed on top of the payload container. (Para. 0042-0043 and 0045)
Lantz discloses at least one tray but it does not specifically disclose the at least one tray comprises dimensions A x B x H, where A is in a range from 228 to 233 mm, B is in a range from 228 to 233 mm, and H is in a range from about 38 to 46 mm and the payload container is sized and shaped to be able to receive the at least one tray.
However, Tomes teaches that it was known in the art to have a tray 100 that comprises dimensions A x B x H, where A is in a range from 228 to 233 mm (9-12in. equiv. to 228.6-304.8mm), B is in a range from 228 to 233 mm (8-11in. equiv. to 203.2-279.4mm), and H is in a range from about 38 to 46 mm (1-3in. equiv. to 25.4-76.2mm) and the payload container 1000 is sized and shaped to be able to receive the at least one tray.
Lantz discloses the payload container maybe sized to hold a range and value of articles, to be shipped, 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 tray in Lantz by having it comprise the above dimensions as taught by Tomes for the purposes of allowing the essential articles needed to be organized and arranged inside of the payload container tray.
With regards to claim 112, Lantz (Fig. 2) discloses the system comprises one or more glass vials housed on or within the at least one tray, the one or more glass vials (Para. 0043; line 6) containing a temperature-sensitive material, wherein the temperature-sensitive material comprises a biological and/or pharmaceutical composition (human growth hormone or a vaccine), and wherein at least one of a chemical, physical, and medicinal property of the biological and/or pharmaceutical composition is impacted by elevated temperatures. (Para. 0043)
With regards to claim 118, Lantz discloses a tray and a glass vial that can hold a dose (human growth hormone, or a vaccine; para. 0043) and wherein the one or more glass vials comprises is capable of being one or more multi-dose vials, depending on the dose to be held but it does not specifically disclose each tray is configured to contain at least 25 of the one or more glass vials, or wherein at least one tray contains at least 25 of the one or more glass vials.
Lantz recites in para. 0066, the structures may be resized and shaped to accommodate different volumes of contents. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the tray hold 25 vials, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04.
With regards to claim 133, the combination of Lantz in view of Tomes discloses the at least one tray comprises multiple trays stacked vertically, and wherein the dry ice container (42; Lantz Fig. 2) is disposed directly on top of the top tray of the multiple trays stacked vertically.
Lantz discloses multiple payload container 32 stacked vertically and Tomes teaches it was known in the art to have a tray to a tray packaged in the payload container, therefore, Lantz in view of Tomes discloses the at least one tray comprises multiple trays stacked vertically.
Claim(s) 113 and 115 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lantz US 2006/0174648 A1 in view of Tomes et al. US 2016/0166800 A1 and further in view of Aragon US 2005/0188715 A1, previously presented.
With regards to claim 113, Lantz discloses a container system that holds a temperature sensitive material but it does not specifically disclose a temperature monitoring system and a light sensor.
However, Aragon teaches that it was known in the art to have a container system that holds a temperature sensitive material that includes a temperature monitoring system and a light sensor. (Para. 0021 and 0027)
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 container system in Lantz by providing a temperature monitoring system and a light sensor as taught by Aragon for the purposes of alerting the user when the temperature has changed in the container and when the container has been opened.
With regards to claim 115, Lantz in view of Tomes discloses the payload container is capable of containing 2, 3, 4, or 5 trays simultaneously (Lantz; multiple payload container 32 stacked vertically and Tomes; teaches trays packaged), however, Lantz does not specifically disclose the container system is capable of maintaining the temperature of the temperature-sensitive material within the tray at -50°C or lower for at least 10 days.
However, Aragon teaches that it was known in the art to have a container system capable of maintaining the temperature of the temperature-sensitive material within the tray at -50°C or lower for at least 10 days. (end of Para. 0015)
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 container system in Lantz by maintaining the temperature of the temperature-sensitive material within the tray at -50°C or lower for at least 10 days as taught by Aragon for the purposes of preventing contamination and ensuring product safety and effectiveness over a period of time.
Claim(s) 114 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lantz US 2006/0174648 A1 in view of Tomes et al. US 2016/0166800 A1, in view of Aragon US 2005/0188715 A1 and further in view of Azenta Life Sciences (see NPL-U previously attached to the PTO-892), both previously presented.
With regards to claim 114, the combination of Lantz in view of Aragon (Para. 0021) discloses the temperature monitoring system comprises a temperature sensor and a display, wherein the temperature monitoring system is capable of displaying or warning when the temperature inside the payload container have critical changes but it does not specifically disclose the temperature monitoring system is capable of displaying or warning when the temperature inside the payload container is greater than about -80° C.
However, it is old and well known in the art that biological material degrade over time when not stored at appropriate temperatures. In addition, it is old and well known that there are different temperature ranges at which biological materials, vaccines etc. need to be stored at, and will need to be placed at for the thawing process. Ultra-low freezer storage and cryogenic freezer storage include temperatures around -80 degrees Celsius and lower. For example Azenta Life Sciences discloses these type of storage and temperatures.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to have the temperature monitoring system capable of displaying or warning when the temperature inside the payload container is greater than about -80° C. since it was held that where the general conditions of a claim are disclosed in the prior art (e.g. Aragon discloses monitoring and warning when critical changes occur in temperature, and Azenta Life Sciences discloses different ranges for storing biological material), it is not inventive to discover the optimum ranges by routine experimentation. In addition, as set forth by Azenta Life Sciences, storing at appropriate temperatures will prevent degradation of biological materials.
Claim(s) 119-120 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tattam US 6,089,038 in view of Tomes et al. US 2016/0166800 A1.
With regards to claim 119, Tattam discloses a container system 1 comprising: a) a primary container 7; b) a payload container 6; c) a dry ice container 3; d) dry ice pellets 5 (Col 4:46-50) disposed within the dry ice container; wherein the payload container is submerged in the dry ice pellets.
Tattam discloses the payload container transports temperature sensitive products and keeps them either cool or protects them during transit but it does not specifically disclose at least one tray and the payload container is sized and shaped to be able to receive the at least one tray, and wherein the at least one tray comprises dimensions A x B x H, where A is in a range from 228 to 233 mm, B is in a range from 228 to 233 mm, and H is in a range from 38 to mm.
However, Tomes teaches that it was known in the art to have at least one tray 100 that comprises the dimensions A x B x H, where A is in a range from 228 to 233 mm (9-12in. equiv. to 228.6-304.8mm), B is in a range from 228 to 233 mm (8-11in. equiv. to 203.2-279.4mm), and H is in a range from about 38 to 46 mm (1-3in. equiv. to 25.4-76.2mm) and the payload container 1000 is sized and shaped to be able to receive the at least one tray 100.
Tattam discloses the payload container maybe sized and shaped to hold a range and value of articles, to be shipped, 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 payload container in Tattam by having it comprise a tray with the above dimensions as taught by Tomes for the purposes of allowing the essential articles needed to be organized and arranged inside of the payload container.
With regards to claim 120, the combination of Tattam in view of Tomes discloses the payload container (6; Tattam) is sized and shaped to be able to receive at least one tray (100; Tomes) containing a temperature sensitive material (product in 6; Tattam).
Claim(s) 121 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tattam US 6,089,038 in view of Tomes et al. US 2016/0166800 A1 and further in view of ZHANG et al. US 2018/0362243 A1.
With regards to claim 121, Tattam discloses the claim invention (container system that holds a temperature sensitive material) as stated above but it does not specifically disclose a temperature monitoring system, a light sensor, and a global positioning system (GPS) enabled thermal sensor.
However, ZHANG teaches that it was known in the art to have a container system that holds a temperature sensitive material have a temperature monitoring system (304; Para. 0062 and 0067), a light sensor (Para. 0067), and a global positioning system (GPS) enabled thermal sensor (303; Para. 0021-0022),
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 container system in Tattam by providing a temperature monitoring system, a light sensor, and a global positioning system (GPS) enabled thermal sensor as taught by ZHANG for the purposes of ensure safe transportation of the cargoes.
Claim(s) 130 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tattam US 6,089,038, previously presented, in view of Tomes et al. US 2016/0166800 A1 and further in view of McCormick US 2010/0162734 A1, previously presented.
With regards to claim 130, Tattam discloses the claimed invention (dry-ice pellets) as stated above but it does not specifically disclose the dry-ice pellets comprise 10 mm to 16 mm dry-ice pellets.
However, McCormick teaches that it was known in the art to have a container have dry-ice pellets 34 comprise 10 mm to 16 mm dry-ice pellets. (Para. 0018)
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 dry-ice pellets in Tattam by providing them with 10 mm to 16 mm dry-ice pellets as taught by McCormick for the purposes of cooling down the articles in the container.
Claim(s) 131-132 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lantz US 2006/0174648 A1 in view of Tomes et al. US 2016/0166800 A1 and further in view of DEUTSCHLE et al. US 2017/0073091 A1.
With regards to claim 131, Lantz discloses at least one tray but it does not specifically disclose the at least one tray is composed of a polypropylene material.
However, DEUTSCHLE teaches it was known in the art to have a tray composed of a polypropylene material. (Para. 0121)
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 tray in Tattam by having it composed of polypropylene material as taught by DEUTSCHLE for the purposes of having the tray be durable, reusable, mold resistant and moisture resistant.
With regards to claim 132, Lantz discloses at least one tray but it does not specifically disclose the at least one tray is composed of Biplex®.
It is known in the art that Biplex® is a commercially available twin-wall, extruded corrugated sheet made from a polypropylene copolymer material. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the tray composed of Biplex®, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07
Claim(s) 134 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lantz US 2006/0174648 A1 in view of Tomes et al. US 2016/0166800 A1 and further in view of Barnett et al. US 2015/0140068 A1, previously presented.
With regards to claim 134, Lantz discloses the biological and/or pharmaceutical composition but it does not specifically disclose it comprises an RNA lipid nanoparticle (LNP) vaccine concentrate.
However, Barnett teaches a biological and/or pharmaceutical composition comprises an RNA lipid nanoparticle (LNP) vaccine concentrate. (Para. 0355-0356)
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 biological and/or pharmaceutical composition in Lantz by having the composition be RNA lipid nanoparticle (LNP) vaccine concentrate as taught by Barnett for the purposes of transporting alternative types of articles.
Claim(s) 135 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lantz US 2006/0174648 A1 in view of Tomes et al. US 2016/0166800 A1 and further in view of Abbasova et al. US 2015/0344580 A1.
With regards to claim 135, Lantz discloses a glass vial (a multi-dose vial depending on the dose to be held in the vial) and at least one tray but it does not specifically disclose a plurality of vials, wherein the at least one tray is configured to contain the plurality of vials, wherein the plurality of vials comprises exactly 169, 188 or 195 vials, and wherein each vial of the plurality of vials comprises a 2 ml type 1 glass, preservative- free.
However, Abbasova teaches that it was known in the art to have a vial be a 2 ml type 1 glass and preservative-free. (Para. 0259 and 0260)
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 vial in Lantz by having it be a 2 ml type 1 glass and preservative-free as taught by Abbasova for the purposes of providing an alternative type of vial material.
Lantz discloses a vial but it does not disclose the at least one tray is configured to contain a plurality of vials, wherein the plurality of vials comprises exactly 169, 188 or 195 vials.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the tray of Lantz hold to contain the plurality of vials, wherein the plurality of vials comprises exactly 169, 188 or 195 vials, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04
Claim(s) 136 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lantz US 2006/0174648 A1 in view of Tomes et al. US 2016/0166800 A1 and further in view of Abbasova et al. US 2015/0344580 A1.
With regards to claim 136, Lantz discloses a container system for transporting and storage of temperature-sensitive material comprising: a) a primary container 10; b) a payload container 30/32 that is configured to receive at least one tray; c) a dry ice container 42; and d) a vial (para. 0043), and wherein the primary container comprises a top portion and a bottom portion, and the primary container is configured to receive the payload container in the bottom portion and to receive the dry ice container in the top portion.
Lantz discloses at least one tray but it does not specifically disclose the at least one tray comprises dimensions A x B x H, where A is in a range from 228 to 233 mm, B is in a range from 228 to 233 mm, and H is in a range from about 38 to 46 mm and the payload container is sized and shaped to be able to receive the at least one tray.
See claim 110, for Tomes teaching of a tray comprising the above dimensions and having the payload container and sized and shaped to be able to receive the at least one tray.
Lantz discloses a vial but it does not disclose the at least one tray is configured to contain a plurality of vials, wherein the plurality of vials comprises exactly 169, 188 or 195 vials.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the tray of Lantz hold to contain the plurality of vials, wherein the plurality of vials comprises exactly 169, 188 or 195 vials, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04
The glass vial in Lantz is capable of being a multi-dose vial depending on the dose to be held in the vial but it does not specifically disclose each vial of the plurality of vials comprises a 2 ml type 1 glass and preservative-free.
See claim 135, for Abbasova teaching of a 2 ml type 1 glass and preservative-free vial.
Response to Arguments
Applicant’s arguments with respect to claim(s) 110, 112-115, 118-121 and 130-136 have been considered but are moot because of a new ground of rejection. Konarski and Bylo, that are referenced in the remarks are no longer recited in the art rejection above. However, with regards to the Applicants argument concerning claim 121 and the reference Zhang not teaching the “light sensor” as claimed. The present specification does not provide any specific details regarding the features or structure relating to the “light sensor” in claim 121. As far as can be determined Zhang provides a device mechanism that functions with the lighting system of the container and therefore meets the claim limitation.
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.
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/JENINE SPICER/Examiner, Art Unit 3736
/ORLANDO E AVILES/Supervisory Patent Examiner, Art Unit 3736
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