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 .
Preliminary Remarks
Claims 7 and 25 are amended, claims 1-6, and 11 were canceled, and claims 12-20 were not elected and therefore withdrawn from consideration. Therefore, claims 7-10, and 12-26 remain pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/16/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 7-10, 21-26 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 of the instant application does not provide support for a “first polymeric seal”, a “first polymeric cap”, and a “second polymeric cap”.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7-8 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0000062 A1-Chen et al. (hereafter Chen) and further in view of US 2016/0000062 A1-Chen et al. (hereafter Chen, referring to embodiments 5A-5C, and Fig. 6) and US 6,736,799 B1-Erbe et al. (hereinafter Erbe).
Regarding claim 7, Chen teaches a device for freezing, thawing, and administering a therapeutic cell mixture, (cellular material and/or implantable material, para. [0001]; Chen teaches thawing of the device—para. [0001]). Additionally, Chen teaches a container (pouch 1, para. [0032], line 2, Figs. 2A-2B) comprising a first open end (open end 5, Figs. 2A-2B, para. [0125], 13, Figs. 2A-2B) having a first diameter (shown in Figs. 2A-2B); a second open end having a second diameter that is smaller than the first diameter (port 9, para. [0048], line 3, Figs. 2A-2B). Further, Chen teaches Figs 2A-2B show the second open end (port 9) has a second diameter is smaller than the first diameter (first diameter of first open end, open end 5); a lumen, comprising a lumen wall, in fluid communication with the first and second open end, and having a lumen diameter that is similar to the first diameter, (pouch 1, comprises a lumen, that is the inside of pouch/container 1, and a lumen wall, that is, wall of pouch/container 1, as shown in Figs. 2A-2B in communication with the first and second open end (open end 5 and port 9, respectively, where the inside or lumen of container/pouch 1 is similar to the first diameter (diameter of first open end 5,shown in Fig. 2A), wherein the container is constructed of one or more biocompatible materials that maintain structural integrity when frozen at less than -130 °C and thawed (Chen teaches pouch 1 may be made from biocompatible materials (para. [0048], lines 2-3); and Chen teaches freezing the pouch until the temperature of the pouch reaches about -70° C or lower (para. [0128], lines 17-18). However, Chen does not explicitly teach a second open end defines a luer lock shaped to accept a syringe need with a compatible structure.
For claim 7, Erbe teaches an invention relating to apparatuses for the delivery of biological composites that facilitate imbibation and infiltration of porous substrate (col. 1, lines 11-14) and Erbe teaches the point for attachment 63 is a male Luer lock connector 90 that threadingly engages the distal end 62 of the dismountable end cap 60 and allows for attachment (col. 4, lines 47-50), which reads on the instant claim limitation of a second open end defines a luer lock shaped to accept a syringe need with a compatible structure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Chen to include a second open end defines a luer lock shaped to accept a syringe need with a compatible structure as taught by Erbe, because Erbe teaches a needle on the end of a luer lock allow for the aspiration of fluids (col. 4, lines 50-51).
Additionally, regarding claim 7, a different embodiment of Chen, referring to Figs. 5A-5C, teaches a packaging assembly may include pouches, tubes, and a bag made of a sealable, flexible polymeric material (abstract) and a first polymeric seal (lumen of syringe/tube 20 sealed on one end by a cap 31 attached to a luer lock, 5A-5C & Fig. 6, that is, the first polymeric seal of Chen is capable of seating entirely within the lumen and creating a seal), where the seal is in contact with the lumen wall 9 (inside of syringe/tube 20), where the first polymeric cap (cap, 31, Figs. 5A-5C & Fig. 6, seals first open end (open end 30) and extends over the first open end (open end 30, Figs. 5A-5C) and a second polymeric cap (cap 11, Figs. 5A-5C & Fig. 6), where the first polymeric seal and the first polymeric cap together form a barrier, which reads on the instant claim limitation of a first polymeric cap designed to seal the first open end and extending over the first open end; and a second polymeric cap designed to seal the second open end; wherein the first polymeric seal and the first polymeric cap create a barrier that prevents gas exchange between the lumen and the device's exterior.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Chen to include a first polymeric cap designed to seal the first open end and extending over the first open end; and a second polymeric cap designed to seal the second open end; wherein the first polymeric seal and the first polymeric cap create a barrier that prevents gas exchange between the lumen and the device's exterior, in order to allow for the storage of the cellular contents of the tube/syringe. Also, Chen teaches the seal to prevent fluid leaking from the packaging (para. [0040, lines 3-4). Additionally, Chen teaches the sealing of the container/tube allows for the end of the connector to avoid the dead space that could trap cells or tissues and to allow for maximum product retrieval after storage (para. [0032], lines 8-10).
Regarding claim 8, Chen teaches the invention discussed above. Chen teaches a container. However, Chen does not teach wherein the container defines a syringe barrel, and the first polymeric seal is a piston or plunger.
For claim 8, a different embodiment of Chen teaches a packaging assembly may include pouches, tubes, and a bag made of a sealable, flexible polymeric material (abstract) and a different embodiment of Chen teaches a container defining a syringe barrel (cylindrical tube 29, Fig. 6) having a first polymeric seal is a piston or plunger (plunger 32, para. [0070], line 15), which reads on the instant claim limitation of wherein the container defines a syringe barrel, and the first polymeric seal is a piston or plunger.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Chen to include wherein the container defines a syringe barrel, and the first polymeric seal is a piston or plunger because a different embodiment of Chen teaches the entire contents within the rigid tube (29) may be pushed out by the plunger (32, para. [0070], lines 17-19).
Regarding claim 21, Chen teaches the invention discussed above in claim 7. However, Chen does not explicitly teach wherein the second polymeric cap is a needle end cap.
For claim 21, a different embodiment of Chen teaches a packaging assembly may include pouches, tubes, and a bag made of a sealable, flexible polymeric material (abstract) and a different embodiment of Chen teaches a second polymeric cap (cap 11 and connector 10, Fig. 11, para. [0025]), which reads on the instant claim limitation of wherein the second polymeric cap is a needle end cap.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Chen to include wherein the second polymeric cap is a needle end cap because a different embodiment of Chen teaches the presence of a needle with side channels, and is also adapted for use of a plunger to discharge tissue and/or cellular material (para. [0025], Fig. 11).
Regarding claim 22, Chen teaches the invention discussed above in claim 7. However, Chen does not explicitly teach wherein the first polymeric cap is a barrel cap.
For claim 21, a different embodiment of Chen teaches a packaging assembly may include pouches, tubes, and a bag made of a sealable, flexible polymeric material (abstract) and a different embodiment of Chen teaches a first polymeric cap is a barrel cap (connector 37, para. [0075], line 7, Fig. 11), which reads on the instant claim limitation of wherein the first polymeric cap is a barrel cap.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Chen to include wherein the first polymeric cap is a barrel cap a different embodiment of Chen teaches the presence of a needle with side channels, and is also adapted for use of a plunger to discharge tissue and/or cellular material (para. [0025], Fig. 11).
Regarding claim 23, Chen teaches the invention discussed above. Chen teaches a container. However, Chen does not teach wherein the first polymeric seal is a plunger, defining a plunger acceptor structure for accepting a plunger rod.
For claim 23, a different embodiment of Chen teaches a different embodiment of Chen teaches a packaging assembly may include pouches, tubes, and a bag made of a sealable, flexible polymeric material (abstract) and a different embodiment of Chen teaches a container defining a syringe barrel (cylindrical tube 29, Fig. 6) having a first polymeric seal is a piston or plunger (plunger 32, para. [0070], line 15), which reads on the instant claim limitation wherein the first polymeric seal is a plunger, defining a plunger acceptor structure for accepting a plunger rod.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Chen to include wherein the first polymeric seal is a plunger, defining a plunger acceptor structure for accepting a plunger rod because a different embodiment of Chen teaches the entire contents within the rigid tube (29) may be pushed out by the plunger (32, para. [0070], lines 17-19).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0000062 A1-Chen et al. (hereafter Chen) and in view of US 2016/0000062 A1-Chen et al. (hereafter Chen, referring to embodiments 5A-5C, and Fig. 6) and US 6,736,799 B1-Erbe et al. (hereinafter Erbe) as applied to claim 9 above, and further in view of US 2015/0044765 A1-Inoue.
Regarding claim 9, modified Chen teaches the invention discussed above in claim 8. Further, modified Chen teaches a container made of a polymer. However, modified Chen does not explicitly teach wherein the container is made of a translucent polymer.
For claim 9, Inoue teaches an invention relating to a cell cryopreservation tool used in cryopreservation cells such as mammalian ova, eggs such as embryos, sperms, and stem cells such as hematopoietic stem cells, pluripotent stem cells, and the like (Para. [0001], lines 1-4). Further, Inoue teaches a cryopreservation tool 1 having a tubular body 30 (Para. [0058], line 5, Fig. 1, where tubular body 30 is semitransparent (Para. [0061], lines 6-7), and the material is a polymer (Para. [0061], lines 8-13 which reads on the instant claim limitation of wherein the container is made of a translucent polymer.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to take the modified invention of Chen to include a container is made of a translucent polymer as taught by Inoue, because Inoue teaches when the tubular body is transparent or semitransparent (translucent), it allows for visual recognition of the inside of the body (Para. [0061], lines 4-6).
Regarding claim 10: “wherein the container is made of a polymeric cyclic olefin.”: Chen teaches the biocompatible material may include, but is not limited to cyclic olefin copolymer (para. [0033], line 8).
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0000062 A1-Chen et al. (hereafter Chen) and in view of US 2016/0000062 A1-Chen et al. (hereafter Chen, referring to embodiments 5A-5C, and Fig. 6) and US 6,736,799 B1-Erbe et al. (hereinafter Erbe) as applied to claim 7 above, and further in view of US 6,190,364 B1-Imbert.
Regarding claim 24, modified Chen teaches the invention discussed above in claim 7. Further, modified Chen teaches a first polymeric seal and a first open end. However, Chen does not explicitly teach wherein an adhesive is positioned between the first polymeric seal and at or near the first open end.
For claim 24, Imbert teaches an invention relating to an effective tip cap assembly for a hypodermic syringe (the container), and to a hypodermic syringe assembly having a more effectively sealed tip (col. 2, lines 25-27). Further, Imbert teaches the chamber wall defines a fluid-receiving chamber which may be pre-loaded with a selected dose of medication (col. 2, lines 30-32). Additionally, Imbert teaches a first open end (proximal end 14, which has an opening, where the opening of the proximal end 14 allows for plunger rod 26 to be inserted into the syringe barrel 12, col. 3, line 51, Fig. 1) and Imbert teaches adhesives (col. 6, line 23), which reads on the instant claim limitation of an adhesive.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to take the modified invention of Chen to include an adhesive as taught by Imbert. Imbert teaches adhesives of the device allow for securing or sealing of the device. Also, Imbert teaches adhesives allow for attaching of a luer collar to a syringe barrel tip (col. 6, lines 22-23).
Regarding claim 25, Chen teaches a device for freezing, thawing, and administering a therapeutic cell mixture, (cellular material and/or implantable material, para. [0001]; Chen teaching thawing of the device—para. [0001]). Additionally, Chen teaches a container (pouch 1, para. [0032], line 2, Figs. 2A-2B) comprising a first open end (open end 5, Figs. 2A-2B, para. [0125], 13, Figs. 2A-2B) having a first diameter (shown in Figs. 2A-2B); a second open end having a second diameter that is smaller than the first diameter (port 9, para. [0048], line 3, Figs. 2A-2B). Further, Chen Figs 2A-2B show the second open end (port 9) has a second diameter is smaller than the first diameter (first diameter of first open end, open end 5); a lumen, comprising a lumen wall, in fluid communication with the first and second open end, and having a lumen diameter that is similar to the first diameter, (pouch 1, comprises a lumen, that is the inside of pouch/container 1, and a lumen wall, that is, wall of pouch/container 1, as shown in Figs. 2A-2B in communication with the first and second open end (open end 5 and port 9, respectively, where the inside or lumen of container/pouch 1 is similar to the first diameter (diameter of first open end 5,shown in Fig. 2A), wherein the container is constructed of one or more biocompatible materials that maintain structural integrity when frozen at less than -130 °C and thawed (Chen teaches pouch 1 may be made from biocompatible materials (para. [0048], lines 2-3); and Chen teaches freezing the pouch until the temperature of the pouch reaches about -70° C or lower (para. [0128], lines 17-18). However, Chen does not explicitly teach a second open end defines a luer lock shaped to accept a syringe need with a compatible structure.
For claim 25, Erbe teaches an invention relating to apparatuses for the delivery of biological composites that facilitate imbibation and infiltration of porous substrate (col. 1, lines 11-14) and Erbe teaches the point for attachment 63 is a male Luer lock connector 90 that threadingly engages the distal end 62 of the dismountable end cap 60 and allows for attachment (col. 4, lines 47-50), which reads on the instant claim limitation of a second open end defines a luer lock shaped to accept a syringe need with a compatible structure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Chen to include a second open end defines a luer lock shaped to accept a syringe need with a compatible structure as taught by Erbe, because Erbe teaches a needle on the end of a luer lock allow for the aspiration of fluids (col. 4, lines 50-51).
Additionally, regarding claim 25, referring to a different embodiment of Chen teaches a packaging assembly may include pouches, tubes, and a bag made of a sealable, flexible polymeric material (abstract) and a different embodiment of Chen teaches a container defining a syringe barrel (cylindrical tube 29, Fig. 6) having a first polymeric seal is a piston or plunger (plunger 32, para. [0070], line 15), which reads on the instant claim limitation of a first polymeric seal defining a plunger configured to seat within the lumen and create a sealing contact with the lumen wall, wherein the plunger comprises a structure for accepting a plunger rod.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Chen to include a first polymeric seal defining a plunger configured to seat within the lumen and create a sealing contact with the lumen wall, wherein the plunger comprises a structure for accepting a plunger rod because a different embodiment of Chen teaches the entire contents within the rigid tube (29) may be pushed out by the plunger (32, para. [0070], lines 17-19).
Moreover, regarding claim 25, Chen teaches the invention discussed above. Further, Chen teaches a first polymeric cap designed to seal a first open end, which extends over the first open end (the first polymeric cap (cap, 31, Figs. 5A-5C & Fig. 6, seals first open end (open end 30) and extends over the first open end (open end 30, Figs. 5A-5C). However, Chen does not explicitly teach an adhesive.
Additionally, for claim 25, Imbert teaches an invention relating to an effective tip cap assembly for a hypodermic syringe (the container), and to a hypodermic syringe assembly having a more effectively sealed tip (col. 2, lines 25-27). Further, Imbert discloses the chamber wall defines a fluid-receiving chamber which may be pre-loaded with a selected dose of medication (col. 2, lines 30-32). Additionally, Imbert discloses a first open end (proximal end 14, which has an opening, where the opening of the proximal end 14 allows for plunger rod 26 to be inserted into the syringe barrel 12, col. 3, line 51, Fig. 1) and Imbert teaches adhesives (col. 6, line 23), which reads on the instant claim limitation of an adhesive.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Chen to include an adhesive to allow for securing or sealing of the device. Also, Imbert teaches adhesives allow for attaching of a luer collar to a syringe barrel tip (col. 6, lines 22-23).
Also, regarding claim 25, Chen teaches the invention discussed above. Further, Chen teaches a first polymeric seal and a first polymeric barrier. However, Chen does not explicitly teach wherein the first polymeric seal and the first polymeric cap create a barrier that prevents gas exchange between the lumen and the device's exterior.
Also, for claim 25, Chen teaches an invention relating to improved pouches, tubes and packaging assemblies for storing, distributing, treating, mixing, and dispensing tissue and/or cellular material and/or implantable material. The invention is particularly useful for storage and cryopreservation of mammalian tissue and/or cellular material (para. [0001]) and a different embodiment of Chen teaches assembly may include tubes made of polymeric material (abstract); and Chen teaches a first polymeric seal (a plunger, para. [0066, Fig. 6, that is, the first polymeric seal of Chen is capable of seating entirely within the lumen and creating a seal) and a first polymeric cap (cap 11, para. [0066], Fig. 6), which create a barrier, which reads on the instant claim limitation of wherein the first polymeric seal and the first polymeric cap create a barrier that prevents gas exchange between the lumen and the device’s exterior.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Chen to include wherein the first polymeric seal and the first polymeric cap create a barrier that prevents gas exchange between the lumen and the device’s exterior as taught by Chen, in order to prevent damage to the stored contents and to prevent contamination (para. [0040]).
Regarding claim 26, Chen teaches the invention discussed above in claim 25. However, Chen does not explicitly teach wherein at least one of the plunger, first polymeric cap, and second polymeric cap comprise a material selected from silicone, polypropylene, butyl rubber, and natural rubber.
For claim 26, a different embodiment of Chen teaches a cylindrical tube made from biocompatible materials (para. [0063], lines 2-4) and the different embodiment teaches a plunger (23) with a conical shape plunger head (25) may be pushed into the rigid tube (20). The plunger head (25), which may be made of silicon or thermoplastic elastomer (para. [0064], lines 4-7), which reads on the instant claim limitation of wherein at least one of the plunger, first polymeric cap, and second polymeric cap comprise a material selected from silicone, polypropylene, butyl rubber, and natural rubber.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Chen to include wherein at least one of the plunger, first polymeric cap, and second polymeric cap comprise a material selected from silicone, polypropylene, butyl rubber, and natural rubber as taught by the different embodiment of Chen, because the different embodiment of Chen teaches the silicon or thermoplastic elastomer, provides a seal of the tube (para. [0064], lines 6-8).
Response to Arguments
Applicant's arguments filed 01/16/1984 have been fully considered but they are not persuasive. Applicant’s remarks begin on the middle of page 7, here, applicant cites the relied upon prior art noted in the Office Action mailed on 07/16/2025. Further, on the middle of page 7 of applicant’s remarks, applicant discussed Fig. 2 of Chen. Further, applicant asserts Fig.2 of Chen lacks a first polymeric seal. This argument continues on the top of page 8 of applicant’s remarks. In response, it is unclear which Fig. 2 applicant is referring to, since Chen provides Figures 2A and 2B. However, when referring to the relied upon Figs. 5A-5C of Chen, Chen teaches a packaging assembly may include pouches, tubes, and a bag made of a sealable, flexible polymeric material (abstract) and a first polymeric seal (lumen of syringe/tube 20 sealed on one end by a cap 31 attached to a luer lock, 5A-5C & Fig. 6, that is, the first polymeric seal of Chen is capable of seating entirely within the lumen and creating a seal).
Additionally, applicant cites the motivation to combine discussed in the Action mailed on 07/16/2025, on page 7 of the Action. Applicant merely asserts “Chen’s embodiments of Figs. 2A, 2B, 5A, and 5B are incompatible with modification with each other or the devices of Erbe, Inoue, and Imbert, to arrive at applicant’s device.” Rather, applicant cites case law However, applicant has not provided any clear reasonings to arrive at this conclusion. Further, as noted in the previously mailed Action, Chen teaches the seal to prevent fluid leaking from the packaging (para. [0040, lines 3-4). Additionally, Chen teaches the sealing of the container/tube allows for the end of the connector to avoid the dead space that could trap cells or tissues and to allow for maximum product retrieval after storage (para. [0032], lines 8-10). The latter teaching of Chen provides a motivation to modify the device of Chen.
On the bottom of page 8 and the top of page 9, applicant asserts “the embodiment of FIGs. 5A, 5B, 5C, and 6 is similarly flawed. Here, Chen explicitly states that after assembling/threading the barrel with the second open end, there first polymeric cap must be removed to insert the first polymeric seal. It is neither suggested nor is it reasonable to expect that the skilled artisan would modify such a device in contradiction of the instructions. Indeed, the only reason to create Applicant's device is provided by Applicant's disclosure.” In response, as discussed above in this section, a first polymeric seal (lumen of syringe/tube 20 sealed on one end by a cap 31 attached to a luer lock, 5A-5C & Fig. 6, that is, the first polymeric seal of Chen is capable of seating entirely within the lumen and creating a seal), where the seal is in contact with the lumen wall 9 (inside of syringe/tube 20), where the first polymeric cap (cap, 31, Figs. 5A-5C & Fig. 6, seals first open end (open end 30) and extends over the first open end (open end 30, Figs. 5A-5C) and a second polymeric cap (cap 11, Figs. 5A-5C & Fig. 6), where the first polymeric seal and the first polymeric cap together form a barrier.
On the top and middle of page 9 of applicant’s remarks, applicant discusses Chen’s Figs. 1A, 1B, 2A, and 2B, and assert the latter figures depict a heat-sealed flexible pouch, not a syringe barrel designed for a use with a polymeric seal plunger. Further, applicant further asserts Chen requires cap removal prior to plunger insertion and the embodiments of Chen are not intended for administering a cell therapeutic and not able to accept a syringe needle. In response, paragraph 0013, states “a rigid tube may be adapted for engagement within the assembly with a needle which includes one or more side channels. According to this aspect of the invention, the needle may be useful for adding cells or biological solutions to the packaging assembly. Also, Chen teaches the invention relates to distributing, treating, mixing, and dispensing tissue and/or cellular material and/or implantable material (para. [0001]).
Additionally, on the middle of page 9 of applicant’s remarks, applicant asserts Chen’s cap 31 and plunger 32 are never present together, nor are they intended to be, rather, Chen requires cap removal prior to plunger assertion. In response, applicant’s citation of paragraph 0070 of Chen, appears to be somewhat mischaracterized. Chen explicitly discloses “the threaded cap (31) may be removed and a plunger (32) may be fit into the rigid tube (29).” That is, the term may presents an alternative. Chen does not teach that the plunger 32 has to be or needs to be removed.
At the bottom of page 9 and the top of page 10, applicant asserts “the Office’s resort to Chen’s general field statement ‘the invention is particularly useful for storage and cryopreservation of mammalian tissues and/or cellular material’ is not a teaching or suggestion of applicant’s specific device…” In response, contrary to applicant’s assertion, the citation by applicant viewed as vague, is in fact from paragraph 0001 of Chen, and more specifically, it describes the field of invention of the device. It appears applicant has misconstrued latter citation noted in the previously mailed Action, as a teaching or suggestion. The citation of paragraph 0001 of Chen was relied upon to give a brief understanding and summary of the device of Chen. Additionally, Chen was relied upon for its similar field of invention and teachings of similar features to that of the claimed invention discussed above.
Lastly, toward the bottom of page 10 of applicant’s remarks, applicant discusses unexpected results of the disclosed invention. Applicant asserts the claimed invention showed enhanced integrity at cryogenic temperatures, and applicant asserts the cited art failed to even consider such issues. In response, it is disclosed throughout the document the use of lower temperature, in particular, than -70°C. In response to the assertion of unexpected results, since the combination of the references present a structural modification similar to that of the claimed invention, one would likely achieve the same result as the claimed invention.
Conclusion
THIS ACTION IS MADE FINAL. 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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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799