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 .
Election/Restrictions
Applicant’s election with traverse of Group I (Claims 1-11; drawn to a method for bioprocessing comprising expanding a population of genetically modified cells in a first and second bioreactor) in the reply filed on February 2, 2026, is acknowledged.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Groups II and III), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 7, 2024.
Applicant further elected the following species:
a. Genetically modifying cells in the first bioreactor
In light of the Applicant’s elected species, claims 7 and 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Response to Arguments
Applicant's arguments filed February 2, 2026, are acknowledged.
Applicant argues that the technical features shared between the alleged inventions are special technical features as the cited art (WO2019106207 (Griffin)) does not directly and unambiguously disclose where one population of cells is split into two bioreactors after activation and modification in a first bioreactor (page 2, paragraph 1).
Applicant's arguments have been fully considered but they are not persuasive.
As an initial matter, the claims of Group II do not claim performing any steps within a second bioreactor. Therefore, this cannot be a special technical feature associated with each of Groups I-III. Furthermore, as stated in the restriction mailed on December 1, 2025, Groups I-III lack unity of invention because the groups do not share the same or corresponding technical feature.
Groups I-II do not require transferring the population of activated cells out of the first bioreactor for genetic modification as required by Group III.
Group II requires activating, genetically modifying and expanding two populations of cells that is not required by Groups I and III.
Additionally, although Applicant argues this is a special technical feature, the special technical feature between Groups I-III is considered a method of bioprocessing comprising providing a bioprocessing system having a first and second bioreactor vessel, activating a population of cells in the first bioreactor, genetically modifying the cells, and expanding the population of cells in the first bioreactor. This technical feature is not a special technical feature as it does not make a contribution over the prior art in view of World Intellectual Property Organization Patent Application No. 2019106207 (Griffin; referenced in IDS).
Griffin discloses a method for bioprocessing, comprising the steps of: providing (see figures 1, 3) a bioprocessing system (bioprocessing system-10, fluid flow architecture-400) having a first bioreactor vessel (first bioreactor vessel-410) and a second bioreactor vessel (second bioreactor vessel-420); activating a population of cells in the first bioreactor vessel (paragraph [0205], figure 59); genetically modifying the population of cells to produce a population of genetically modified cells (paragraphs [0214], [0216], figure 71 ); and expanding the population of genetically modified cells within the first bioreactor vessel (paragraph [0245]).
DETAILED ACTION
The claims filed on May 25, 2023, have been acknowledged. Claims 1-20 are pending. In light of the Applicant’s elected invention and species, claims 7 and 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-6 and 8-11 are pending and examined on the merits.
Priority
The applicant claims domestic priority from U.S. provisional application No. 63/125,838, filed on December 15, 2020. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-6 and 8-11 receive domestic benefit from U.S. provisional application No. 63/125,838, filed on December 15, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) filed on May 25, 2023, July 31, 2023, February 5, 2024, June 4, 2025, October 28, 2025, March 5, 2026, and May 7, 2026, have been considered.
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 1-6 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over World Intellectual Property Organization Patent Application No. 2019106207 (Griffin, referenced in IDS).
Regarding claim 1, Griffin teaches a method of bioprocessing comprising: providing a bioprocessing system 400 includes a first bioreactor vessel 410 and a second bioreactor vessel 420. The first bioreactor vessel includes at least a first port 412 and a first bioreactor line 414 in fluid communication with the first port 412, and a second port 416 and a second bioreactor line 418 in fluid communication with the second port 416. Similarly, the second bioreactor vessel includes at least a first port 422 and a first bioreactor line 424 in fluid communication with the first port 422, and a second port 426 and a second bioreactor line 428 in fluid communication with the second port 426;
activation of cells is carried out in a first bioreactor vessel and the activated cells are transferred to the second bioreactor vessel for transduction and expansion (paragraphs 000114-000245).
Griffin does not teach wherein expansion of the population of genetically modified cells occurs within the first and second bioreactor.
However, Griffin teaches that the system of the invention may allow for activation and transduction operations to be carried out in a first bioreactor vessel, and expansion of the genetically modified cells carried out in a second bioreactor vessel. Moreover, in an embodiment, the system of the invention may allow for the in-situ processing of isolated T cells wherein the activation, transduction and expansion unit operations are all performed within a single bioreactor vessel. Furthermore, the bioreactor vessels 410, 420 are perfusion-enabled, silicone membrane-based bioreactor vessels that support activation, transduction and expansion of a population of cells therein. The bioreactor vessels 410, 420 may be used for cell culture, cell processing, and/or cell expansion to increase cell density for use in medical therapeutics or other processes. While the bioreactor vessel may be disclosed herein as being used in conjunction with particular cell types, it should be understood that the bioreactor vessel may be used for activation, genetic modification and/or expansion of any suitable cell type.
As shown in FIG. 3, the interconnect line 450 also provides for fluid communication between the second bioreactor line 418 and first bioreactor line 414 of the first bioreactor vessel 410, allowing for circulation of a fluid along a first circulation loop of the first bioreactor vessel. Similarly, the interconnect line also provides for fluid communication between the second bioreactor line 428 and first bioreactor line 424 of the second bioreactor vessel 420, allowing for circulation of a fluid along a second circulation loop of the second bioreactor vessel. Moreover, the interconnect line 450 further provides for fluid communication between the second port 416 and second bioreactor line 418 of the first bioreactor vessel 410, and the first port 422 and first bioreactor line 424 of the second bioreactor vessel 420, allowing for the transfer of contents of the first bioreactor vessel 410 to the second bioreactor vessel 420, as discussed hereinafter.
As illustrated in FIG. 68, after the second bioreactor vessel 420 is coated with the viral vector, the post-wash cells from the first bioreactor vessel 410 are transferred to the second bioreactor vessel 420 for transduction/genetic modification. In particular, valves 434, 452 and 436 are opened and the circulation line pump 456 is actuated to pump the cells out of the first bioreactor vessel 420 through the second port 416 of the first bioreactor vessel 410, through interconnect line 450, to the first bioreactor line 424 of the second bioreactor vessel 420, and into the second bioreactor vessel 420 through the first port 422 of the second bioreactor vessel 420.
Furthermore, Griffin identifies multiple examples of bioreactor vessel workflows that are enabled by the system of the invention that identify both bioreactors are capable of performing some combination of activation, genetic modification, and expansion (paragraphs 000114-000245).
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 bioprocessing method of Griffin by expanding the genetically modified cells in the first and second bioreactor to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because Griffin teaches that both bioreactors are individually capable of activation, genetic modification, and expansion. Furthermore, Griffin teaches that the system allows for communication between the bioreactors to transfer cells for expansion. As both bioreactors are capable of performing expansion and there is already a means of transferring cells between bioreactors for expansion, it would have been well understood that one could modify the system of Griffin to only transfer half of the genetically modified cells from the first bioreactor to the second bioreactor, allowing expansion of cells in both bioreactors. The benefit to this system is that it would increase the number of cells that could be expanded per each round of genetic modification by increasing the expansive capacity of the cells through increased expansion area (i.e. double the amount compared to performing expansion in a single bioreactor), limiting the amount of genetic modification reagents needed. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Regarding claim 2, Griffin teaches that Dynabead activation and Lentiviral transduction can occur in the first bioreactor vessel 410, and expansion in the second bioreactor vessel 420 (paragraph 000245).
Furthermore, as stated supra, it would have been well understood that one could modify the system of Griffin to only transfer half of the genetically modified cells (i.e. a subset) from the first bioreactor to the second bioreactor, allowing expansion of cells in both bioreactors.
Regarding claim 3, Griffin teaches that post-activation and viral transduction, the virus may then be washed out of the bioreactor vessel 410 using the filterless perfusion method that retains the cells and the micron-sized Dynabeads in the bioreactor vessel 410 (paragraphs 000239-000241).
Regarding claims 4 and 8, Griffin teaches that post-activation cells can be washed and concentrated prior to genetic modification (paragraphs 000199-000217).
Regarding claim 5, Griffin teaches that washing utilizes an in-situ hollow fiber filtration-based system (paragraph 000229).
Regarding claim 6, Griffin teaches that harvesting of the expanded populations of cells from the bioreactors can likewise be accomplished using a single third module 300 when each expanded populations of cells are ready for harvest (paragraphs 000118 and 000240).
Regarding claim 9, Griffin teaches that a bioprocessing method includes activating cells of a population of cells in a bioreactor vessel using magnetic or non-magnetic beads to produce a population of activated cells, genetically modifying the activated cells in the bioreactor vessel to produce a population of genetically modified cells, washing the genetically modified cells in the bioreactor vessel to remove unwanted materials, and expanding the population of genetically modified cells in the bioreactor vessel to produce an expanded population of transduced cells (paragraph 00028).
Regarding claim 10, Griffin teaches that Dynabead activation can occur in the first bioreactor vessel 410, and RetroNectin coating, transduction and expansion can occur in the second bioreactor vessel 420 (paragraph 000245). As stated supra, it would have been well understood that one could modify the system of Griffin to only transfer half of the genetically modified cells (i.e. a subset) from the first bioreactor to the second bioreactor, allowing expansion of cells in both bioreactors. Similarly, it would have been also obvious that one could modify the system of Griffin to only transfer half of the genetically modified cells (i.e. a subset) from the second bioreactor to the first bioreactor, allowing expansion of cells in both bioreactors.
Regarding claim 11, Griffin does not teach concentrating the genetically modified cells before expansion.
However, Griffin does teach that a bioprocessing method includes activating cells of a population of cells in a bioreactor vessel using magnetic or non-magnetic beads to produce a population of activated cells, genetically modifying the activated cells in the bioreactor vessel to produce a population of genetically modified cells, washing the genetically modified cells in the bioreactor vessel to remove unwanted materials, and expanding the population of genetically modified cells in the bioreactor vessel to produce an expanded population of transduced cells (paragraph 00028).
Referring now to FIG. 64, and depending on the concentration obtained from the sample, concentration may be carried out by circulating the contents of the first bioreactor vessel 410 through the filter 484. As discussed above, this is accomplished by opening valves 434, 486, 488 and 432 and actuating pump 456, which causes circulation of the solution in the first bioreactor vessel 410 out of the second port 416, through the second bioreactor line 418, through the interconnect line 450, through the :filtration line 482 and filter 484, through the first bioreactor line 414 of the first bioreactor vessel 410, and back to the first bioreactor vessel 410 through the first port 412. As the fluid passes through the filter 484, waste is removed and permeate pump 492 pumps such waste to the waste reservoir 472a of the second fluid assembly 444 through waste line 490.
Washing involves the same steps described above for concentration, except the pump 454 on the first fluid assembly line 442 is used to pump in additional culture media to replace the fluid pumped from the permeate waste pump 492 (paragraphs 000210 and 000229).
As Griffin already teaches that genetically modified cells can undergo washing prior to expansion and that the methods of washing and concentration are very similar and both led to removal of waste, it would have been well understood that the genetically modified cells could have been concentrated instead of washed as both have the end result of removing waste. Furthermore, Griffin has already identified that there is only a minor change to the protocol between washing and concentrating cells. Additionally, the steps of viral transduction and expansion would use different media. Therefore, it would have been obvious that one could concentrate the cells after genetic modification to limit the amount of viral transduction reagents in the media during expansion. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11920119. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1 and 6, ‘119 claims a bioprocessing system, comprising: a first module configured in a first configuration for enriching and isolating a first population of cells; a second module configured in a second configuration for activating, genetically modifying, and expanding the first population of cells; and a third module configured in a third configuration for harvesting the expanded first population of cells; wherein the first, second, and third modules are each functionally closed systems such that the first module is configured for enriching a second population of cells while the second module is carrying out activation, genetic modification, and/or expansion on the first population of cells. The bioprocessing system of claim 1, wherein: the second module includes a first bioreactor vessel and a second bioreactor vessel fluidly interconnected with the first bioreactor vessel. The bioprocessing system of claim 3, wherein: the first bioreactor vessel is configured for carrying out activation and genetic modification of the population of cells; wherein the second bioreactor vessel is configured for carrying out expansion of the population of cells. further comprising: a plurality of second modules, each second module configured for activating, genetically modifying and expanding the cells; wherein each second module is configured to support activation, genetic modification and expansion (claims 1-5, 7, 9, an 14-19).
‘119 does not claim wherein expansion of the population of genetically modified cells occurs within the first and second bioreactor.
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 bioprocessing method of ‘119 by expanding the genetically modified cells in the first and second bioreactor to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because ‘119 claims that both bioreactors are individually capable of activation, genetic modification, and expansion. Furthermore, ‘119 claims that the system allows for communication between the bioreactors to transfer cells for expansion. As both bioreactors are capable of performing expansion and there is already a means of transferring cells between bioreactors for expansion, it would have been well understood that one could modify the system of ‘119 to only transfer half of the genetically modified cells from the first bioreactor to the second bioreactor, allowing expansion of cells in both bioreactors. The benefit to this system is that it would increase the number of cells that could be expanded per each round of genetic modification by increasing the expansive capacity of the cells through increased expansion area (i.e. double the amount compared to performing expansion in a single bioreactor), limiting the amount of genetic modification reagents needed. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Regarding claim 2, ‘119 claims the bioprocessing system of claim 3, wherein: the first bioreactor vessel is configured for carrying out activation and genetic modification of the population of cells; wherein the second bioreactor vessel is configured for carrying out expansion of the population of cells (claim 4).
Furthermore, as stated supra, it would have been well understood that one could modify the system of ‘119 to only transfer half of the genetically modified cells (i.e. a subset) from the first bioreactor to the second bioreactor, allowing expansion of cells in both bioreactors.
Claims 1-5 and 8-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11920119 in view of World Intellectual Property Organization Patent Application No. 2019106207 (Griffin).
Regarding claims 3-5 and 8-10, ‘119 claims that the first bioreactor vessel and/or the second bioreactor vessel is configured for filterless perfusion (claim 6).
‘119 does not claim washing their genetically modified cells.
However, Griffin teaches a method of bioprocessing comprising: providing a bioprocessing system 400 includes a first bioreactor vessel 410 and a second bioreactor vessel 420. The first bioreactor vessel includes at least a first port 412 and a first bioreactor line 414 in fluid communication with the first port 412, and a second port 416 and a second bioreactor line 418 in fluid communication with the second port 416. Similarly, the second bioreactor vessel includes at least a first port 422 and a first bioreactor line 424 in fluid communication with the first port 422, and a second port 426 and a second bioreactor line 428 in fluid communication with the second port 426;
activation of cells is carried out in a first bioreactor vessel and the activated cells are transferred to the second bioreactor vessel for transduction and expansion (paragraphs 000114-000245).
Griffin teaches that the system of the invention may allow for activation and transduction operations to be carried out in a first bioreactor vessel, and expansion of the genetically modified cells carried out in a second bioreactor vessel. Moreover, in an embodiment, the system of the invention may allow for the in-situ processing of isolated T cells wherein the activation, transduction and expansion unit operations are all performed within a single bioreactor vessel. Furthermore, the bioreactor vessels 410, 420 are perfusion-enabled, silicone membrane-based bioreactor vessels that support activation, transduction and expansion of a population of cells therein. The bioreactor vessels 410, 420 may be used for cell culture, cell processing, and/or cell expansion to increase cell density for use in medical therapeutics or other processes. While the bioreactor vessel may be disclosed herein as being used in conjunction with particular cell types, it should be understood that the bioreactor vessel may be used for activation, genetic modification and/or expansion of any suitable cell type.
Regarding claim 3, Griffin teaches that post-activation and viral transduction, the virus may then be washed out of the bioreactor vessel 410 using the filterless perfusion method that retains the cells and the micron-sized Dynabeads in the bioreactor vessel 410 (paragraphs 000239-000241).
As ‘119 already claims their device is configured for filterless perfusion with the first and second bioreactors, it would have been obvious that one could use filterless perfusion to wash the cells after genetic modification, as done by Griffin, to remove waste while retaining the cells.
Regarding claims 4 and 8, Griffin teaches that post-activation cells can be washed and concentrated prior to genetic modification (paragraphs 000199-000217).
As ‘119 already claims their device is configured for filterless perfusion with the first and second bioreactors, it would have been obvious that one could use filterless perfusion to wash the cells after activation and prior to genetic modification, as done by Griffin, to remove waste while retaining the cells.
Regarding claim 5, Griffin teaches that washing utilizes an in-situ hollow fiber filtration-based system (paragraph 000229).
As Griffin also uses filterless perfusion and Griffin identifies that in-situ hollow fiber filtration-based system can be used as a filterless perfusion system, it would have been obvious that this known filterless perfusion system could also be used as part of the method of ‘119.
Regarding claim 9, Griffin teaches that a bioprocessing method includes activating cells of a population of cells in a bioreactor vessel using magnetic or non-magnetic beads to produce a population of activated cells, genetically modifying the activated cells in the bioreactor vessel to produce a population of genetically modified cells, washing the genetically modified cells in the bioreactor vessel to remove unwanted materials, and expanding the population of genetically modified cells in the bioreactor vessel to produce an expanded population of transduced cells (paragraph 00028).
As ‘119 already claims their device is configured for filterless perfusion with the first and second bioreactors, it would have been obvious that one could use filterless perfusion to wash the cells after genetic modification, as done by Griffin, to remove waste while retaining the cells.
Regarding claim 10, ‘119 claims the first bioreactor vessel is configured for performing activation of the population of cells; and the second bioreactor vessel is configured for performing genetic modification and expansion of the population of cells (claim 7) As stated supra, it would have been well understood that one could modify the system of ‘119 to only transfer half of the genetically modified cells (i.e. a subset) from the first bioreactor to the second bioreactor, allowing expansion of cells in both bioreactors. Similarly, it would have been also obvious that one could modify the system of ‘119 to only transfer half of the genetically modified cells (i.e. a subset) from the second bioreactor to the first bioreactor, allowing expansion of cells in both bioreactors.
Regarding claim 11, ‘119 does not teach concentrating the genetically modified cells before expansion.
However, Griffin does teach that a bioprocessing method includes activating cells of a population of cells in a bioreactor vessel using magnetic or non-magnetic beads to produce a population of activated cells, genetically modifying the activated cells in the bioreactor vessel to produce a population of genetically modified cells, washing the genetically modified cells in the bioreactor vessel to remove unwanted materials, and expanding the population of genetically modified cells in the bioreactor vessel to produce an expanded population of transduced cells (paragraph 00028).
Referring now to FIG. 64, and depending on the concentration obtained from the sample, concentration may be carried out by circulating the contents of the first bioreactor vessel 410 through the filter 484. As discussed above, this is accomplished by opening valves 434, 486, 488 and 432 and actuating pump 456, which causes circulation of the solution in the first bioreactor vessel 410 out of the second port 416, through the second bioreactor line 418, through the interconnect line 450, through the :filtration line 482 and filter 484, through the first bioreactor line 414 of the first bioreactor vessel 410, and back to the first bioreactor vessel 410 through the first port 412. As the fluid passes through the filter 484, waste is removed and permeate pump 492 pumps such waste to the waste reservoir 472a of the second fluid assembly 444 through waste line 490.
Washing involves the same steps described above for concentration, except the pump 454 on the first fluid assembly line 442 is used to pump in additional culture media to replace the fluid pumped from the permeate waste pump 492 (paragraphs 000210 and 000229).
As Griffin already teaches that genetically modified cells can undergo washing prior to expansion and that the methods of washing and concentration are very similar and both led to removal of waste, it would have been well understood that the genetically modified cells could have been concentrated instead of washed as both have the end result of removing waste. Furthermore, Griffin has already identified that there is only a minor change to the protocol between washing and concentrating cells. Additionally, the steps of viral transduction and expansion would use different media. Therefore, it would have been obvious that one could concentrate the cells after genetic modification to limit the amount of viral transduction reagents in the media during expansion. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
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/KEENAN A BATES/Examiner, Art Unit 1631
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