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 .
Response to Amendment
The Amendment filed 05/28/2025 has been entered. Claims 1-5 and 7-14 remain pending in the application. Claims 13-14 are withdrawn. Claim 6 is canceled. Claims 1-5 and 7-12 are being examined herein.
Status of Objections and Rejections
The rejections of claims 11 and 12 under 35 U.S.C 112(b) are obviated by Applicant’s amendments
The rejection of claim 6 is obviated by Applicant's cancellation.
The rejections of claims 1-5 and 7-12 under 35 U.S.C. 102 and 35 U.S.C. 103 are being withdrawn in view of Applicant’s amendment.
New grounds for rejection under 35 U.S.C. 103 are necessitated by Applicant’s amendments.
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.
Claims 1-5 and 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20200332247 A1) in view of Klaus (US 20060014274 A1).
Regarding claim 1, Smith teaches a cell purification module (filter 8), configured to purify a plurality of cells from a fluid sample, comprising (see annotated figure below, Figure A):
a hollow column (cartridge housing of filter 8), having a first opening, a second opening opposite to the first opening (see annotated Fig. A), and an accommodating space (space within the cartridge housing of filter 8) connecting the first opening and the second opening (Fig. 3);
a plurality of hollow fiber membranes (hollow fiber) (para. 0048 teaches “each fiber” of the hollow fiber filter cartridge is a long tube, the usage of “each” evidences that there is a plurality of hollow fibers)(If it is determined that Smith fails to teach a plurality of hollow fibers, one of ordinary skill in the art before the effective filing date would recognize the benefit of having a plurality of hollow fibers over a singular hollow fiber for increase of filtration area and thus improvement in filtration efficiency. Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cell purification module taught by Smith to incorporate a plurality of hollow fibers in the hollow fiber filter cartridge in order to improve filtration efficiency with a reasonable expectation of success), disposed in the accommodating space (the hollow fibers are housed within the cartridge housing of filter 8), and each of the hollow fiber membranes has a plurality of pores (para. 0048);
at least one first magnetic component (magnet 9), disposed at a periphery of the hollow column;
a fluid sample inlet end, disposed at one end of the hollow column (see annotated Fig. A); and
a fluid sample outlet end, disposed at another end of the hollow column (see annotated Fig. A),
wherein the hollow column has an axial direction extending in a direction of an axis of the hollow column, a radial direction extending in a cross-sectional radius direction of the hollow column and perpendicular to the axial direction of the hollow column, and a circumferential direction surrounding the axis of the hollow column (Fig. 3, the cartridge housing is cylindrical and thus has axial, radial and circumferential directions), the plurality of hollow fiber membranes extend in the axial direction of the hollow column (the tubular structure of the hollow fibers (para. 0048), the axial direction of the flow, and it is evident that the typical structure of hollow fiber cartridges comprises hollow fibers extending in the axial direction), and the plurality of hollow fiber membranes are arranged in the radial direction of the hollow column (based on the tubular structure of the hollow fibers (para. 0048), the axial direction of the flow, and the structure of the cartridge, it is evident that the hollow fibers are arranged in the radial direction of the column); and
a plurality of blind tubes, disposed in the accommodating space, wherein the plurality of blind tubes extend in the axial direction of the hollow column and are arranged in the radial direction of the hollow column, and the plurality of blind tubes are surrounded by the plurality of hollow fiber membranes (either Smith or modified Smith teaches a plurality of hollow fibers. Given that the claim does not further limit the limitation “blind tubes”, the examiner interprets a group of the plurality of hollow fibers in the module of Smith to be blind tubes).
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Figure A. Annotated Fig. 3 of Smith
Smith further teaches the invention is for isolating cells for cell therapy using a hollow fiber filter (paras. 0003 and 0034). Smith discloses each fiber of the hollow fiber filter cartridge is a long tube with multiple pores along its length (para. 0048). Smith further discloses when whole blood that has been treated with RBC lysis buffer is passed through the cartridge, cellular debris from RBCs will get lodged in these pores of the hollow fiber and into the waste, suggesting that at least one end of the hollow fiber is has at least one open end.
Therefore, Smith fails to teach each of the blind tubes, which are a group of the hollow fibers, is a solid cylinder or a hollow tubular structure with closed inlet and outlet.
However, Klaus teaches the use of a plurality of hollow fibers for filtration for applications in medicine, cellular biology, microbiology and biotechnology such as filtration and harvesting of cells (paras. 0002 and 0076). Klaus further teaches the hollow fibers can be open at one end, at both ends or closed at both ends (para. 0061). Klaus further teaches fibers that are closed at both ends can be employed as an absorption medium for separation of substances in fluids containing cells (paras. 0063, 0076 and 0100).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the hollow fibers with at least one end taught by Smith with the hollow fibers with both ends closed as taught by Klaus because one of ordinary skill in the art would accordingly have recognized the hollow fibers with both ends closed would result in the predictable result of providing separation fluids containing cells.
The teachings of Smith as modified by Klaus would yield each of the blind tubes (which are a group of the hollow fibers) is a hollow tubular structure with closed inlet and outlet (both ends, which are the inlet and outlet, of a tubular hollow fiber structure are closed).
Regarding claim 2, modified Smith teaches all of the elements of the current invention as stated above with respect to claim 1. Smith further teaches the at least one first magnetic component comprises one or more first magnetic components disposed at at least one side along the circumferential direction of the hollow column (see the annotated figure above, Figure A).
Regarding claim 3, modified Smith teaches all of the elements of the current invention as stated above with respect to claim 1. Smith further teaches the at least one first magnetic component comprises one or more first magnetic components annularly surrounding the hollow column (see the annotated figure above, Figure A).
Regarding claim 4, modified Smith teaches all of the elements of the current invention as stated above with respect to claim 1. Smith further teaches The cell purification module according to claim 1, further comprising: at least one filtrate outlet end, disposed on the hollow column (see the annotated figure above, Figure A), so that a filtrate flowing out from the plurality of pores flows out through the filtrate outlet end (para. 0048).
Regarding claim 5, modified Smith teaches all of the elements of the current invention as stated above with respect to claim 1. With respect to “wherein the fluid sample comprises at least one cellular fluid and a plurality of magnetic beads, and the cellular fluid comprises at least a plurality of cells and a cell culture medium,” the fluid sample is not a positively recited element of the cell purification module. Claim 1 recites the cell purification module is configured to purify a plurality of cells from a fluid sample, and thus the fluid sample does further limit the configuration of the module. However, the claimed module is not patentably distinguishable from Smith’s invention since Smith’s invention is capable of purifying a plurality of cells from a fluid sample comprising magnetic beads, a plurality of cells and a cell culture medium (paras. 0003, 0015, 0027 and 0048).
Regarding claim 7, modified Smith teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Smith further teaches the plurality of blind tubes and the plurality of hollow fiber membranes are all annularly arranged around the axis of the hollow column, and a ratio of a total length of the plurality of blind tubes in the radial direction of the hollow column to a diameter of the hollow column is 1:10 to 8:10 (as discussed in claim 6, a group of hollow fibers meets the limitation of a plurality of blind tubes. Of the group of hollow fibers, the examiner interprets a group that satisfies the claimed ratio as corresponding to the blind tubes).
Regarding claim 8, modified Smith teaches all of the elements of the current invention as stated above with respect to claim 5. With respect to “a size of the plurality of cells is larger than a pore diameter of the plurality of pores of the plurality of hollow fiber membranes”, the claim attempts to further limit the size of the cells. However, the plurality of cells are not positive recited elements of the module, and thus the size the plurality of cells does not further limit the structure of the claimed invention.
Regarding claim 9, Smith teaches a cell purification system (1), comprising:
a cell purification module, configured to purify a plurality of cells from a fluid sample, comprising (see annotated figure below, Figure B):
a hollow column (cartridge housing of filter 8), having a first opening, a second opening opposite to the first opening (annotated Fig. B), and an accommodating space (space within the cartridge housing of filter 8) connecting the first opening and the second opening;
a plurality of hollow fiber membranes (hollow fiber) (para. 0048 teaches “each fiber” of the hollow fiber filter cartridge is a long tube, the usage of “each” evidences that there is a plurality of hollow fibers), disposed in the accommodating space, and each of the hollow fiber membranes has a plurality of pores (para. 0048) (If it is determined that Smith fails to teach a plurality of hollow fibers in a hollow fiber filter cartridge, one of ordinary skill into art before the effective filing date would recognize the benefit of having a plurality of hollow fibers over a singular hollow fiber for the increase of filtration area and thus improvement in filtration efficiency. Therefore, It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cell purification module taught by Smith to have a plurality of hollow fibers in the hollow fiber filter cartridge in order to improve filtration efficiency with a reasonable expectation of success);
at least one first magnetic component, disposed at a periphery of the hollow column;
a fluid sample inlet end, disposed at one end of the hollow column (see annotated Fig. B); and
a fluid sample outlet end, disposed at another end of the hollow column (see annotated Fig. B),
wherein the hollow column has an axial direction extending in a direction of an axis of the hollow column, a radial direction extending in a cross-sectional radius direction of the hollow column and perpendicular to the axial direction of the hollow column, and a circumferential direction surrounding the axis of the hollow column (Fig. 3, the cartridge housing is cylindrical and thus has axial, radial and circumferential directions), the plurality of hollow fiber membranes extend in the axial direction of the hollow column (based on the tubular structure of the hollow fibers (para. 0048), the axial direction of the flow, and the typical structure of hollow fiber cartridges, it is evident that the hollow fibers extends in the axial direction), and the plurality of hollow fiber membranes are arranged in the radial direction of the hollow column (based on the tubular structure of the hollow fibers (para. 0048), the axial direction of the flow, and the typical structure of hollow fiber cartridges, it is evident that the hollow fibers are arranged in the radial direction of the column);
a storage container (fluid processing reservoir 7), configured to store the fluid sample (interprets as a functional limitation. See MPEP 2114. Para. 0033 teaches fluid processing reservoir 7 is capable of storing a fluid sample), and connected to the fluid sample outlet end of the cell purification module through a first pipeline (a sealed fluid path 5 that connects fluid processor reservoir 7 and the fluid sample outlet end of filter 8) (paras. 0013-0016, 0065-0068, and 0031, the fluid sample is circulated between filter 8 and fluid processor reservoir 7, and thus there is a sealed path 5 that connects fluid processing reservoir 7 and the fluid sample outlet end of filter 8) and
a peristaltic pump (fluid pump 3. Para. 0029, fluid pump is a peristaltic pump), configured to push the fluid sample to flow (interprets as a functional limitation. See MPEP 2114. Para. 0029, fluid pump 3 is a positive displacement pump, and thus configured to push a fluid sample to flow), wherein the peristaltic pump is respectively connected to the storage container and the fluid sample inlet end of the cell purification module through a second pipeline (a sealed fluid path 5 that connects fluid processing reservoir 7 to fluid pump 3) and a third pipeline (a sealed fluid path 5 that connects the fluid sample inlet end to fluid pump 3)(Fig. 3, paras. 0029 and 0031 teaches fluid pump 5 moves fluid contained in a sealed fluid path, which transfer fluid into and out of fluid processing reservoir 7 and/or filter 8, and thus there is a sealed path that connects fluid processing reservoir 7 to fluid pump 3, and there is a sealed path connects the fluid sample inlet end to the fluid pump 3).
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Figure B. Annotated Fig. 3 of Smith
Smith further teaches the invention is for isolating cells for cell therapy using a hollow fiber filter (paras. 0003, 0034). Smith discloses each fiber of the hollow fiber filter cartridge is a long tube with multiple pores along its length (para. 0048). Smith further discloses when whole blood that has been treated with RBC lysis buffer is passed through the cartridge, cellular debris from RBCs will get lodged in these pores of the hollow fiber and into the waste (para. 0048), suggesting that the hollow fiber is has at least one open end.
Therefore, Smith fails to teach each of the blind tubes, which are a group of the hollow fibers, is a solid cylinder or a hollow tubular structure with closed inlet and outlet.
However, Klaus teaches the use of a plurality of hollow fibers for filtration for applications in medicine, cellular biology, microbiology and biotechnology such as filtration and harvesting of cells (paras. 0002 and 0076). Klaus further teaches the hollow fibers can be open at one end, at both ends or closed at both ends (para. 0061). Klaus further teaches fibers that are closed at both ends can be employed as an absorption medium for separation of substances in fluids containing cells (paras. 0063, 0076 and 0100).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the hollow fibers with at least one end taught by Smith with the hollow fibers with both ends closed as taught by Klaus because one of ordinary skill in the art would accordingly have recognized the hollow fibers with both ends closed would result in the predictable result of providing separation fluids containing cells.
The teachings of Smith as modified by Klaus would yield each of the blind tubes (which are a group of the hollow fibers) is a hollow tubular structure with closed inlet and outlet (both ends, which are the inlet and outlet, of a tubular hollow fiber structure are closed).
Regarding claim 10, modified Smith teaches all of the elements of the current invention as stated above with respect to claim 9. Smith further teaches the cell purification system according to claim 9, further comprising: at least one second magnetic component, disposed at a periphery of the third pipeline and adjacent to the fluid sample inlet end. (see annotated figure above, Figure B).
Regarding claim 11, modified Smith teaches all of the elements of the current invention as stated above with respect to claim 10. Smith further teaches at least one second magnetic component comprises one or more second magnetic components disposed at at least one side of the third pipeline (see annotated figure above, Figure B).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20200332247 A1) in view of Klaus (US 20060014274 A1) and further in view of Ye (CN 103062529A).
Regarding claim 12, modified Smith teaches all of the elements of the current invention as stated above with respect to claim 10.
Smith fails to teach the at least one second magnetic component comprises one or more second magnetic components annularly surrounding the third pipeline. Smith also fails to disclose the mechanism by which the third pipeline is connected to the filter 8.
However, Ye teaches a pipe connector (Fig. 1, abstract, paras. 0018 and 0021) for connecting pipes. Ye teaches the pipe connector comprises a magnetic ring (4). Ye further teaches the pipe connector is convenient to use and provides good sealing (abstract).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Smith’s cell purification system to have the pipe connector taught by Ye to connect the third pipeline to filter 8 in order to have a pipe connection that is convenient to use and provides good sealing with a reasonable expectation of success (Ye, abstract) (MPEP 2143)(I)(G).
The teachings of Smith as modified by Ye would yield the at least one second magnetic component comprises one or more second magnetic components annularly (Ye, magnetic ring 4) surrounding the third pipeline.
Response to Amendment
Applicant’s arguments, see page 9, filed 05/28/2025, with respect to the rejections of claims 11 and 12 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejections of 02/28/2025 has been withdrawn.
Applicant's arguments filed 05/28/2025 with respect to the rejections under 35 U.S.C 102 and 35 U.S.C 103 have been fully considered but they are not fully persuasive.
In the arguments presented on p. 10, the Applicant argues that Smith fails to disclose “the blind tubes” for the reason that the hollow fibers taught by Smith “have multiple pores communicating with the exterior which differs from the blind tubes with closed inlet and outlet.”
The examiner respectfully disagrees. A tubular structure typically has an inlet and an outlet at its two ends. A tubular structure made of porous material with closed ends can still be interpreted as a tubular structure with closed inlet and outlet under the broadest reasonable interpretation. Moreover, the amended claims 1 and 9, supported by para. 0043 of the specification, recites “inlet” and “outlet” in the singular instead of plural form, indicating that Applicant did not intend to exclude porous materials, which have multiple inlets and outlets, as a material for the tubular structure at the time of disclosure.
Therefore, this argument is unpersuasive.
However, Smith discloses that “when whole blood that has been treated with RBC lysis buffer is passed through the cartridge, cellular debris from RBCs will get lodged in these pores of the hollow fiber and into the waste” (para. 0048), and thus, suggesting that at least of one of the ends of the hollow fiber is open.
Therefore, Smith fails to disclosed the blind tubes is a hollow tubular structure with closed inlet and outlet. For this reason, the rejections of claims 1-5 and 7-12 under 35 U.S.C. 103 are being withdrawn. However, upon further consideration of the new limitations in amended claim 1, new grounds of rejection under 35 U.S.C. 103 are necessitated by Applicant’s amendments. The rejections are shown above under “Claim Rejections –35 USC § 103”.
Applicant's request filed 05/28/2025 with respect to the rejoined have been fully considered but they are not fully persuasive because of the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 8:30am - 6:00pm.
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758