DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 1-10 and 31-33 are pending and examined on the merits.
Claim 33 is new.
Claims 11-30 are cancelled.
Response to Amendment
Applicant’s amendments filed 12/18/2025 have been fully considered.
Response to Arguments
Applicant’s arguments filed 12/18/2025 have been fully considered. Regarding Applicant’s arguments that substituting Pall’s smaller-porosity filter into Cotter’s device would prevent whole blood from flowing through the filter, causing clogging and rendering the device inoperable for its intended purpose (see page 7 of Remarks filed 12/18/2025). Examiner respectfully disagrees. Specifically, as described by Pall, the filter mechanism may reflect aggregation of red cells as they reach the filter surface, forming a barrier which prevents or blocks flow of platelet rich plasma (PRP) through the filter element (see col. 14, lines 19-24). Furthermore, Pall teaches that a red blood cell barrier medium blocks passage of red cells while allowing passage of platelets (see col. 8, lines 26-34). Therefore, the device of Cotter in view of Pall would also block passage of red cells while allowing passage of platelets.
Additionally, one of ordinary skill in the art would have been motivated to combine the teachings of Cotter and Pall at least because they are analogously in the field of blood collection and filtration (see Abstracts).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cotter (U.S. Patent No. 4,850,964 A) in view of Pall (U.S. Patent No. 5,100,564 A).
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Regarding claim 1, Cotter, with reference to Image 1 above, teaches: A container system for the treatment of a biological fluid (see at least Abstract) comprising:
a) an outer container (see Image 1) including an interior chamber (Id.);
b) an inner container (see Image 1; considered to be the combination of tube 11 and filter material 16) suspended within said interior chamber of said outer container (see Image 1), said inner container comprising at least one wall defining an interior chamber of said inner container (see for example the wall of tube 11 and the wall of filter material 16 in Fig. 2), wherein said wall is made of a porous material selected to allow passage of only certain components of a fluid across said wall (col. 2, lines 37-40 teach that the filter 16 is a mesh filter that collects bone particles contained in blood being picked up from a patient);
c) a port (see Image 1; as broadly claimed, Merriam-Webster Dictionary defines a port as an opening for intake or exhaust of a fluid; therefore, the openings on which sealing caps 12 and 17 are applied are considered ports) communicating with said interior chamber of said outer container (at least inherent because the ports are considered openings on which sealing caps 12 and 17 are applied; therefore, the openings allow for communication with the interior chamber of the outer container); and
d) at least one port communicating with said inner container (see Image 1; see also above for Examiner’s interpretation of the word port)
wherein said ports in communication with said interior chamber of said outer container and with said inner container extend beyond a peripheral sealed edge of said outer container (at least inherent; Image 1 shows the ports as being located beyond a peripheral edge of the outer container).
However, Cotter fails to teach that the porous material is selected to prevent passage of red blood cells through said porous material, as required by the claim.
Pall teaches an analogous container system for collecting and processing blood (see Abstract) comprising filters that prevent the passage of red blood cells (see at least col. 14, lines 13-17).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cotter to incorporate the teachings of Pall by simply substituting the mesh material of Cotter for the filter of Pall with the reasonable expectation of successfully filtering red blood cells, as taught by Pall (see col. 14, lines 13-17).
Since Cotter in view of Pall teaches a container system having each and every claimed structural limitation as in claim 1, the device of Cotter in view of Pall will also necessarily function in the same manner as the claimed device. Specifically, the device of Cotter in view of Pall is for the storage and stabilization and treatment of a cellular blood component during said storage, as required by the claim.
Regarding claims 2-3, Cotter in view of Pall teaches the invention as discussed above in claim 1. Additionally, Cotter teaches wherein said inner and outer containers are made of a polymeric material (see col. 1, lines 60-68; as discussed above, the inner container is comprised of tube 11 and filter material 16; as applied to claim 2); wherein at least said outer container is made of polymeric material that is more rigid than the polymeric material of said inner container (as applied to claim 3; col. 1, lines 67-68 teaches that the tube 11 of the inner container is made of PVC while col. 2, lines 15-16 teaches that the filter material may be a mesh filter; therefore, the inner container comprises a PVC tube and a mesh filter; additionally, col. 1, lines 60-61 teaches that the outer container is made of plastic that is rigid; therefore, the plastic of the outer container is more rigid than the mesh of the inner container).
Regarding claim 4, Cotter in view of Pall teaches the invention as discussed above in claim 1. Additionally, Cotter teaches wherein said outer container includes a sealed peripheral edge (at least inherent; see also Image 1) and said inner container includes a peripheral edge captured within said outer container peripheral sealed edge (at least inherent; as seen in Image 1, the inner container has a peripheral edge completely within the interior chamber of the outer container).
Regarding claim 5, Cotter in view of Pall teaches the invention as discussed above in claim 1. Additionally, Cotter teaches wherein said inner container is suspended within said interior chamber of said outer container (see at least Image 1).
Regarding claim 6, Cotter in view of Pall teaches the invention as discussed above in claim 1. Additionally, Cotter teaches comprising a flow path that communicates with at least said one port and said interior chamber of said inner container (see at least col. 2, lines 37-40 and Fig. 1).
Regarding claim 7, Cotter in view of Pall teaches the invention as discussed above in claim 1. However, while Cotter in view of Pall fails to explicitly teach wherein said inner container has a surface area of approximately 150 - 400 cm2 and said outer container has a surface area of approximately 250 - 600 cm2, as required by the claim, it has been held that, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than a prior art device, the claimed device is not patentably distinct from the prior art device. Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); see also MPEP 2144.04(IV)(A). In the instant case, one of ordinary skill in the art would have reasonably recognized that in order to obtain a desired concentration of red blood cells contained within the inner container, one would change the area of the inner and outer containers in order to change the amount of osmotic fluid being filtered out of the container system.
Claims 8-9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cotter (U.S. Patent No. 4,850,964 A) in view of Pall (U.S. Patent No. 5,100,564 A), as applied above to claim 1, and further in view of Matz (U.S. Patent No. 4,144,165 A).
Regarding claim 8, Cotter in view of Pall teaches the invention as discussed above in claim 1. However, Cotter in view of Pall fails to explicitly teach a sample pouch, as required by the claim.
Matz teaches an analogous container system for the treatment of biological fluid (see at least col. 1, lines 5-15) comprising an inner container (17 in Figs. 1-2) suspended within an interior chamber of an outer container (22 in Fig. 1; see col. 3, line 61). Matz further teaches a sample pouch (see for example syringe 27 in Fig. 3) in flow communication with one of said interior chamber of said inner container and said interior chamber of said outer container (col. 6, lines 18-22 describe that liquid samples are injected into the dialysis device via a syringe).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cotter in view of Pall to incorporate the teachings of Matz by including a sample pouch in flow communication with one of said interior chamber of said inner container and said interior chamber of said outer container at least in order to remove all or a portion of the specimen from the container system for an interim test and then replace it for further processing if desired, as taught by Matz (see col. 6, lines 54-57).
Regarding claim 9, Cotter in view of Pall teaches the invention as discussed above in claim 1. However, Cotter in view of Pall fails to explicitly teach further comprising at least one container of a treating solution in openable flow communication with said interior chamber of said outer container, as required by the claim.
Matz teaches at least one container of a treating solution in openable flow communication with said interior chamber of said outer container (see for example syringe 27 in Fig. 3, col. 4, lines 65-67, and col. 6, lines 18-22).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cotter in view of Pall to incorporate the teachings of Matz by including at least one container of a treating solution in openable flow communication with said interior chamber of said outer container at least to allow for the flushing of the interior of the container system for reuse, as taught by Matz (see col. 6, lines 52-54).
Claim 10 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cotter (U.S. Patent No. 4,850,964 A) in view of Pall (U.S. Patent No. 5,100,564 A), as applied above to claim 1, and further in view of Yi (U.S. Pre Grant Pub. No. 2008/0017577 A1).
Regarding claim 10, Cotter in view of Pall teaches the invention as discussed above in claim 1. However, Cotter in view of Pall fails to explicitly teach wherein said porous material is selected to prevent passage of red blood cells from said inner container to said interior chamber of said outer container, as required by the claim.
Yi teaches an analogous container system for treating a biological fluid (see Abstract) comprising an outer container 12 (see Fig. 1) and an inner container 14 having a porous membrane 70 (see para. [0045]; see also Fig. 2 and para. [0047]); the porous membrane 70 allows transportation of plasma or serum into the inner container 14 while preventing the transfer of blood cells therethrough (see para. [0017]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cotter in view of Pall to incorporate the teachings of Yi by simply substituting the known mesh of Cotter/Pall with the known porous membrane of Yi to obtain a predictable result of having a porous material that prevents the transfer of blood cells from while allowing the transportation of plasma or serum, as taught by Yi (see para. [0017]).
Claims 31-32 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cotter (U.S. Patent No. 4,850,964 A) in view of Pall (U.S. Patent No. 5,100,564 A), as applied above to claim 1, and further in view of Wisdom (U.S. Patent No. 4,596,657 A).
Regarding claims 31-32, Cotter in view of Pall teaches the invention as discussed above in claim 1. However, Cotter in view of Pall fails to explicitly teach wherein the red blood cells are stored in the outer container or inner container for at least 21 days or at least 42 days, as required by the claims.
Wisdom teaches an analogous blood container system (see Abstract) for providing blood that have a storage life of at least 21 days and up to about 35 days (see col. 1, lines 48-55).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cotter in view of Pall to incorporate the teachings of Wisdom by making the container system store red blood cells for at least 21 days (as applied to claim 31 and as disclosed by Wisdom in col. 1, lines 48-55) and/or for at least 42 days (as applied to claim 32) at least since it has been held that “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); see also MPEP 2144.05(I).
Claim 33 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cotter (U.S. Patent No. 4,850,964 A) in view of Pall (U.S. Patent No. 5,100,564 A), as applied above to claim 1, and further in view of Yoshida (U.S. Pre Grant Pub. No. 2013/0047861 A1).
Regarding claim 33, Cotter in view of Pall teaches the invention as discussed above in claim 1. However, Cotter in view of Pall fails to explicitly teach wherein the porous material is further selected to allow passage of only certain components, particles, or ions, by diffusion, from one of the interior chamber of said inner container and the interior chamber of said outer container to the other, as required by the claim.
Yoshida teaches an analogous blood filter device (see Abstract) comprising a membrane or filter material that allows diffusion of oxygen and/or carbon dioxide through the outer surface into the inner mass for binding (see para. [0055]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cotter in view of Pall to incorporate the teachings of Yoshida by modifying the porous material to allow passage of only certain components, particles, or ions, by diffusion, from one of the interior chamber of said inner container and the interior chamber of said outer container to the other at least in order to increase biocompatibility and leukocyte adhesion, as taught by Yoshida (see para. [0055]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/PHILIP R WIEST/ Primary Examiner, Art Unit 3781