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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/13/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/13/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Preliminary Remarks
The amendment filed on 07/13/2026 has been entered. Claims 7-10, 12-13, and 23-26 have been amended, claims 1-6, 11, and 21-22 are canceled, claims 12-20b are withdrawn from consideration, and no claims have been added. Therefore, claims 7-10, 12-20, and 23-26 are pending in the application.
Claim Rejections - 35 USC § 112
Applicant has amended claims 7-10 and 21-26 to overcome the 112(a) rejections cited in the Office Action mailed on 02/13/2026. Therefore, the previously cited rejection is withdrawn.
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 needle 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 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 plunger (plunger 32, para. [0070], line 15, Fig. 6), where plunger 32 may fit into tube 29 (para. [0071], lines 15-16), which reads on the instant claim limitation of a polymeric plunger to seat within the lumen and create a sealing contact within the lumen.
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 polymeric plunger to seat within the lumen and create a sealing contact within the lumen 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).
Additionally, regarding claim 7, a different embodiment of Chen, referring to Figs. 5A-5C, teaches a second polymeric cap (cap 31, Figs. 5A-5C & Fig. 6), which reads on the instant claim limitation of a polymeric barrel cap designed to seal the first open end and extending over the first open end.
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 polymeric barrel cap designed to seal the first open end and extending over the first open end as taught by a different embodiment of Chen, because the other embodiment of Chen teaches cap 31 may be removed in order to allow for the insertion of a plunger to dispense contents (para. [0069]).
Also, regarding claim 7, another embodiment of Chen teaches a polymeric needle end cap (cap 11, Figs. 5A-5C and Fig. 6), where cap 11 I shown in said figures of Chen sealing a second open end (opening of tube 20, para. [0064], lines 3-4), which reads on the instant claim limitation of a polymeric needle end cap designed to seal the second open end.
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 further include a polymeric needle end cap designed to seal the second open end as taught by a different embodiment of Chen, because Chen teaches cap 11 help prevent or avoid any potential contamination (para. [0048], lines 8-10).
Additionally, regarding claim 7, referring to a different embodiment of Chen, (Figs. 5A-5C), teaches a polymeric plunger (plunger 32 para. [0070], line 15, Fig. 6) and the polymeric barrel cap (cap 31, Fig. 6), where the plunger 32 and cap 31 form a barrier that prevents gas exchange, and which reads on the instant claim limitation of wherein the polymeric plunger and the polymeric barrel cap together form 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 further include wherein the polymeric plunger and the polymeric barrel cap together form a barrier that prevents gas exchange between the lumen and the device's exterior as taught by a different embodiment of Chen, because the other embodiment of Chen teaches the plunger is configured to provide a seal and function with smooth movement within the rigid tubing (para. [0091], lines 1-2).
Regarding claim 8, Chen discloses wherein the container defines a syringe barrel (cylindrical tube 29, para. [0066], lines 3-4, Fig. 6).
Regarding claim 23, Chen teaches the invention discussed above in claim 7. However, Chen does not explicitly disclose a plunger.
For claim 23, a different embodiment of Chen, referring to embodiment 6, teaches a plunger, where plunger 23 has a rod portion (the length of the plunger) and a plunger acceptor (an end of plunger 23, Fig. 6), which reads on the instant claim limitation of a 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 a polymeric 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).
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, Chen discloses wherein the container is made of a polymeric cyclic olefin (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 polymeric barrel cap and a first open end. However, Chen does not explicitly teach wherein an adhesive is positioned between the polymeric cap 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).
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); a polymeric needle end cap designed to seal the second open end (cap 11, Figs. 5A-5C & Fig. 6, also, discussed above in claim 7). 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 polymeric seal is a piston or plunger (plunger 32, para. [0070], line 15), which reads on the instant claim limitation of a polymeric plunger defining a plunger configured to seat within the lumen and create a sealing contact with the lumen wall, wherein the polymeric 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 polymeric 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 polymeric barrel cap (cap 31, Figs. 5A-5C & Fig. 6, also, discussed above claim 7) designed to seal a first open end, which extends over the first open end (the polymeric barrel 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 polymeric seal and a polymeric barrier. However, Chen does not explicitly teach wherein the polymeric plunger and the polymeric barrel 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 polymeric plunger (a plunger, para. [0066, Fig. 6, that is, the polymeric plunger of Chen is capable of seating entirely within the lumen and creating a seal) and a polymeric cap (cap 11, para. [0066], Fig. 6), where a barrier is created, which reads on the instant claim limitation of wherein the polymeric plunger and the polymeric barrel 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 polymeric plunger and the polymeric barrel cap create a barrier that prevents gas exchange between the lumen and the device's exterior as taught by Chen, because Chen teaches The sealed package containing tissue and/or cellular material may be placed in a secondary container and sealed again to prevent contamination (para. [0073]).
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, polymeric barrel cap, and polymeric needle cap comprises 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 wherein at least one of the plunger, polymeric barrel cap, and polymeric needle cap comprises 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, polymeric barrel cap, and polymeric needle cap comprises 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 07/13/2026 have been fully considered but they are not persuasive. On the top and middle of page 6 of applicant’s remarks, applicant discusses the status of the claims. On the bottom of page 6 and pages 7 through toward the bottom of page 8 of applicant’s remarks, applicant discusses the 112(a) rejection cited in the Office Action mailed on 02/13/2026. In this section, applicant discusses portions of the MPEP, some paragraphs from the specification of the instant application, and Figs. 1A, 1B, and 2 of the instant application. Applicant has amended the claims to overcome the previously cited rejection.
On the bottom of page 8 and the top of page 9, applicant discusses the relied upon prior art cited in the previously mailed Office Action. Also, applicant recites a limitation of the a claim from the instant application (note, the cited limitation is found in claim 7 and 25 of the instant application). Also, on the middle of page 9 of applicant’s remarks, applicant asserts “Chen does not teach a needle end cap, a plunger and a barrel cap are used together; to the contrary, Chen describes the barrel cap as being removed before a plunger is inserted. Second, the stated motivations to combine Chen's embodiments and the teachings of Erbe are conclusory and erroneously combine incompatible embodiments. Third, only Applicant's disclosure and experimental results provide a reason to create a syringe-like device comprising a plunger, a barrel cap, and a needle end cap for preventing gas exchange. Finally, even if Chen could reasonably be cited for combining a plunger, a barrel cap, and a needle end cap, which Applicant disputes, the presently claimed combination provides an unexpectedly enhanced barrier to gas exchange. Neither Erbe nor Imbert nor Inoue cures Chen's deficiencies.”
In response, addressing applicant’s “first” argument, Chen does teach a needle cap (cap 11), a plunger (plunger 32), and a barrel cap (cap 31). The plunger of Chen forms a seal which forms a barrier and the end cap for the tip of the syringe would also form a gas permeable barrier. Additionally, Fig. 5C, show a handle 27 which may be threaded onto the plunger's (24) male threaded end (26) through its female threaded end (28), para. [0065]); further, Fig. 5C, show a needle cap (cap 11) attached to the tip of the syringe, that is, a plunger and a needle cap used together to form a barrier. Regarding applicant’s “second” argument, the motivation, teaching, or suggestions to combine, noted above in the rejection are not conclusory or erroneous as asserted by applicant, because as stated above in the rejection, Erbe clearly teaches a apparatuses for the delivery of biological composites and Erbe teaches a needle on the end of a luer lock allow for the aspiration of fluids (col. 4, lines 50-51). The claim(s) of the instant application also do not positively recite a needle within the claim, albeit, a needle is mentioned in the claim. Regarding applicant’s “third” argument, applicant discusses experimental results provide a reason to create a syringe-like device…”. This assertion is also not found persuasive. Firstly, the plunger of Chen forms a seal which forms a barrier and the end cap for the tip of the syringe would also form a gas permeable barrier. Additionally, Fig. 5C, show a handle 27 which may be threaded onto the plunger's (24) male threaded end (26) through its female threaded end (28), para. [0065]); further, Fig. 5C, show a needle cap (cap 11) attached to the tip of the syringe, that is, a plunger and a needle cap used together to form a barrier. Also, essentially the claimed invention is a syringe, with a plunger and a cap over a luer lock, which is not novel and known in the art. As discussed above in this section and the rejection, Chen teaches the claimed device.
On the bottom of page 9 and the top and middle of page 10, applicant argues Chen does not teach or suggest combining a needle end cap, a plunger, and a barrel cap to prevent gas exchange between the lumen and the device’s exterior. Applicant alleges “the Office must clearly articulate why the claimed invention would have been obvious and must provide ‘some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness,” applicant also cited section of the MPEP. In response, a noted above in this section, the plunger of Chen forms a seal which forms a barrier and the end cap for the tip of the syringe would also form a gas permeable barrier. Additionally, Fig. 5C, show a handle 27 which may be threaded onto the plunger's (24) male threaded end (26) through its female threaded end (28), para. [0065]); further, Fig. 5C, show a needle cap (cap 11) attached to the tip of the syringe, that is, a plunger and a needle cap used together to form a barrier. Also, essentially the claimed invention is a syringe, with a plunger and a cap over a luer lock, which is not novel and known in the art. Moreover, Chen teaches cap 11 help prevent or avoid any potential contamination (para. [0048], lines 8-10); that is, cap 11 allows for the prevention of contamination of the device of Chen.
On the bottom of page 10, applicant asserts the following: “applicant disagrees that Chen, alone or in combination with Erbe, teaches or suggests installing a needle end cap, a barrel cap and a plunger, such that the barrel cap and the plunger ‘together form a barrier that prevents gas exchange between the lumen and the device's exterior,’ as recited in the independent claims. First, cap 31 in Chen cannot satisfy two separate and structurally distinct claim limitations-i.e. the barrel cap and the plunger. Second, cap 31 in Chen cannot satisfy the plunger limitation at least because the claims require the plunger to ‘seat entirely within the lumen and create a sealing contact with the lumen wall," whereas Chen describes cap 31 as a ‘threaded cap [...] secured in place to seal the threaded end (30)" of the rigid cylindrical tube 29. Depicted at FIG. 6 and described in para. [0069]. Third, the plungers disclosed in Chen (e.g., structure 32 in FIGS. 6 and 11, or plunger 24 and plunger head 25 in FIGS. 5A-5C) fail to satisfy the limitation of ‘seating entirely within the lumen" as they comprise a plunger head 25 or plunger 32 that extend beyond the tube's end (see, e.g., FIGs. 5A-5C showing the plunger head protruding beyond the tube, and see plunger 32 in FIG. 6 extending beyond tube 29). Fourth, the plungers disclosed in Chen are not disclosed to be used together with a needle end cap and a barrel cap to form a barrier that prevents gas exchange as required by the claims.
In response, applicant has mischaracterized the previously mailed Office Action. The Office Action clearly denotes a plunger, which is also identified above in this section and the rejection as plunger 32. Also, cap 11 corresponds to a needle end cap. The latter is also shown in Fig. 5C, where a handle 27 is attached to a plunger head 25 and cap 11 is shown at the other end or tip of the syringe-like device in 5C. Further, Chen teaches a handle (27), optionally provided in a kit, may be threaded onto the plunger's (24) male threaded end (26) through its female threaded end (28). The threaded adaptor (22) may be removed and the entire contents within the rigid tube (20) may be pushed out by the plunger (24) and handle (27) assembly (para. [0065], where the handle assembly 27 forms a barrier to prevent gas exchange, as shown in Fig. 5C. Further, Fig. 5C, has been relied upon throughout the current and rejection, and previous rejections as well. That is, there are two distinct structures, regarding a plunger (plunger 23 and handle assembly 27, discussed above). Cap 31 is not being interpreted as one structure to serve as both a barrel cap and a plunger. Additionally, the previously mailed Office Action, reads as follows: “Chen teaches a polymeric plunger (a plunger, para. [0066, Fig. 6, that is, the polymeric plunger of Chen is capable of seating entirely within the lumen and creating a seal) and a polymeric cap (cap 11, para. [0066], Fig. 6), where a barrier is created, which reads on the instant claim limitation of wherein the polymeric plunger and the polymeric barrel cap create a barrier that prevents gas exchange between the lumen and the device's exterior.” The latter has been mischaracterized by applicant. The latter clearly states a plunger and a cap (cap 11).
Regarding applicant’s argument pertaining to “structures 32 in Figs. 6 and 11 or plunger 24 and head 25 in Figs. 5A-5C fail to satisfy the limitation of ‘seating entirely within the lumen’ as they comprise a plunger head 25 or plunger 32 that extend beyond the tube’s end…”. In response to the latter argument, this argument is not found persuasive because as applicant has mentioned in Figs. 5A-5C, these clearly show the plungers are extended, as indicated by the tissue and/or cellular material 6, still disposed in the tube, in particular Fig. 5C.; and thus, the plunger, plunger head, and handle assembly provide a barrier that prevents gas exchange because both ends of the syringe or tube shown in Figs. 5A-5C are sealed. Moreover, once, the plunger and plunger head and handle assembly are pushed through the tube/syringe, the plunger and plunger head and handle assembly would not be extended. Figures 5A and 5B merely show uncoupled components of the device of Chen and 5C, clearly shows the components of 5A and 5C attached and in a state before the plunger and plunger head and handle assembly is pushed to eject the tissue and/or cellular material 6, as indicated in Fig. 5C. That is, plunger, plunger head, and handle assembly of Chen are extended because the tissue and/or cellular material 6, has not been ejected from the tube, therefore, the plunger, plunger head, and handle assembly is extended, as shown in Fig. 5C.
On the bottom of page 10 and the very top of page 11, applicant asserts “the plungers disclosed in Chen are not disclosed to be used together with a needle end cap and a barrel cap to form a barrier that prevents gas exchange as required by the claims. In response to the latter argument, this argument is also not found persuasive for the reasons discussed directly above in this section. That is, the plunger, plunger head, and handle assembly provide a barrier that prevents gas exchange because both ends of the syringe or tube shown in Figs. 5A-5C are sealed.
Regarding the top of page 11 of applicant’s remarks, applicant appears to suggest plunger of Chen is not used to seal the tube but is only “a tool for pushing out contents”. Moreover, applicant asserts “Chen simply does not teach or suggest the use of a plunger for sealing an open end together with a needle end cap and a barrel cap, forming a gas-tight seal, as required by applicant's claims, and thus, one of ordinary skill in the art would not have had a reason or motivation to modify the structures of Chen (e.g., cap 11, plunger 32 and cap 31) to serve this purpose.” This latter argument is also not found persuasive for the reasons discussed above in the beginning of the section, but also on the bottom of page 21, of this Office Action. Firstly, claim 1 of the instant application essential is a syringe with a plunger and a cap over a luer lock (addressed by the disclosure of Chen). Secondly, the plunger of Chen forms a seal which would form a gas barrier and the end cap for the tip would also form a gas impermeable barrier. The latter is shown in Fig. 5C of Chen. Fig. 5C of Chen is sealed at both ends via the insertion of the handle assembly 27 and plunger head and/ or plunger, as well as by cap 11. A seal is created by the closed ends of both openings of the tube of Chen. Also, applicant’s argument regarding the previous Office Action discussion of “an alternative process”, on the bottom of page 11 and the top of page 12, was relied on and discussed for the purpose of applicant’s mischaracterization that the cap could not be removed, and due to applicant’s assertion that “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”. However, as discussed above in this section, a different embodiment of Chen, that is, Fig. 5C clearly shows a handle assembly option, in Fig. 5C, with a cap coupled to an opposing end of the tube.
On the bottom of page 12 and the top of page 13 of applicant’s remarks, asserts the motivation to combine, for claim 7, is “inconsistent”. Moreover, applicant’s mischaracterization of the previously mailed Office Action is also not found persuasive. That is, applicant asserts “the Office’s own rejection implicitly acknowledges that the claimed device requires two fundamentally different types of structures…”. In response, the claims presented by the instant application recite a plunger configured to seat entirely within the lumen (as discussed above in this section, Fig. 5C of Chen shows a handle assembly disposed in the lumen of the tube and configured to seat entirely within the lumen and create a sealing contact with the lumen wall) and a barrel cap (cap 11, also discussed above, which is also shown in Fig. 5C, extending over an open end of the tube of Chen. The formation of a gas-tight barrier in a syringe is not novel in the art, as indicated by Chen, in the discussion above. The tube of Chen, as shown in Fig. 5C contains tissue and/or cellular material 6. The tissue and/or cellular material has to be contained within the device, for obvious reasons, such as the prevention of contamination (para. [0010], which is discussed throughout the document of Chen.
Moreover, on the middle of page 13, applicant asserts “the Office identifies components of very different Chen embodiments and appears to combine them through conclusory (at best) reasoning. First, the Office cites Chen paragraphs [0032] and [0040], which relate to a flexible pouch and a valve in the connector, respectively, for motivating the sealing of both ends. They do not. On the contrary, the flexible pouch embodiment lacks a plunger and achieves a seal in a different manner. Chen does not teach the use of a plunger in a flexible pouch, and one of skill in the art would understand those structures to be incompatible. Second, the cited embodiment lacks a barrel cap to seal ‘opening (5).’ Instead of a cap, Chen describes sealing the flexible pouch embodiment using ‘a heat sealer.’ See, e.g., Chen Example 3, describing that "[t]he bone matrices were loaded into the pouch from the opening at end (5) of the pouch (see, e.g., FIGS. 1A and 1B) and sealed using a heat sealer at the opening at end (5)’ (emphasis added); see also Chen paras. [0110], [0112], [0119], and [0125]. Finally, for claim 8, Chen's description of the FIG. 6 embodiment refers only to sealing with a "threaded cap (31)" or the "valve (4) within the connector (10)." As noted above, nowhere does Chen teach or suggest sealing the container by combining a plunger, a barrel cap, and a needle end cap. Also, applicant cites KSR on the bottom of page 13 of their remarks.
In response, the latter citations of paragraphs [0040] and [0032], cited in the previous Office Action are have not been relied upon for the current rejection. As discussed above in this section, the entire document discusses the importance of cellular material being sealed in the device of Chen in order to prevent contamination. Moreover, as discussed above, Fig. 5C of Chen shows a handle assembly, which corresponds to a plunger at one end of the tube and a cap 31, extending over the end of the opposing end of the tube of Chen, thus, sealing and forming a barrier that prevents gas exchange between the lumen and the exterior of the tube of Chen.
On the top and middle of page 14, of applicant’s remarks, applicant the cited art does not recognize gas exchange as a problem to be addressed. Then, applicant recite some portions of the disclosure of Chen relied upon from the previously mailed Office Action. In response, as discussed above in this section, Fig. 5C of Chen shows a handle assembly disposed in the lumen of the tube and configured to seat entirely within the lumen and create a sealing contact with the lumen wall) and a barrel cap (cap 11, also discussed above, which is also shown in Fig. 5C, extending over an open end of the tube of Chen. The formation of a gas-tight barrier in a syringe is not novel in the art, as indicated by Chen, in the discussion above. The tube of Chen, as shown in Fig. 5C contains tissue and/or cellular material 6. The tissue and/or cellular material has to be contained within the device, for obvious reasons, such as the prevention of contamination (para. [0010], which is discussed throughout the document of Chen.
On the bottom of page 14 and the top and middle of page 15 of applicant’s remarks, applicant asserts “only impermissible hindsight can motivate the combination of a plunger and a barrel cap in the same device.” In response, the latter argument is not found persuasive because applicant’s claimed invention, essentially is a syringe, with a plunger and a cap over a luer lock, which is not novel and well known in the art. As discussed above in this section and the rejection, Chen teaches the claimed device. Moreover, the formation of a gas-tight barrier in a syringe is not novel in the art, as indicated by Chen, in the discussion above. The tube of Chen, as shown in Fig. 5C contains tissue and/or cellular material 6. The tissue and/or cellular material has to be contained within the device, for obvious reasons, such as the prevention of contamination (para. [0010], which is discussed throughout the document of Chen. Therefore, impermissible hindsight is also mischaracterized by applicant. As stated above in this section, a syringe with two open ends, one end including a plunger and the other including a cap, which inherently forms a barrier to prevent gas exchange is not novel. Also, the material 6 of Chen is enclosed within the tube in such a condition to prevent contamination.
Regarding the bottom of page 15 through the top of page 17 of applicant’s remarks, pertaining to applicant’s unexpected results argument. The discussion of applicant’s unexpected results was not found persuasive to provide enough evidence to overcome the current rejection. Moreover, the structure of the claimed invention is taught by the relied upon art and therefore, one would expect to achieve the same result as that of the claimed invention without a discussion of “unexpected results”. Also, applicant claims unexpected results, but does not articulate a nexus between the prior art of record, the claimed invention and any results and any results that may or may not be in the specification. For the reasons discussed above, claims 7-10, and 23-26 stand rejected and claims 12-20 are withdrawn from consideration.
Conclusion
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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