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. Information Disclosure Statement The information disclosure statement (IDS) submitted on 10/26/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement (IDS) submitted on 05/02/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. A claim limitation will be presumed to invoke 35 U.S.C. 112, sixth paragraph, if it meets the following 3-prong analysis: the claim limitations must use the phrase “means for” or “step for;”, the “means for” or “step for” must be modified by functional language; and the phrase “means for” or “step for” must not be modified by sufficient structure, material, or acts for achieving the specified function. (MPEP 2181) Claim 15 recites “means for generating”, means for serially purifying” and “means for collecting. These limitations follow the 3-prong analysis and so 35 U.S.C. 112 6 th paragraph is invoked. The equivalent structures for these features are a bioreactor (claim 16), an expanded bed or chromatography column (claim 17) and a vessel (claim 18). Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claims 12 -14 and 17-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claims 12, 17 and 18, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 13 and 14 are rejected under 35 U.S.C. 112b since the claims depend upon and incorporate all the limitations of claim 12. Appropriate corrective action is required. Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claims 1- 3, 6-9 and 15-18 are rejected under 35 U.S.C. 102 a1 as being anticipated by Castillo et al. (WO 2019/072584 A1 – hereafter ‘584) . ‘584 discloses a system for producing a biomolecule (Abstract) that includes the following limitations for claim 1: “ A system for producing and purifying target biologics ”: ‘584 discloses a system for producing biomolecules (page 5 lines 28-32). The system of ‘584 is fully capable of purifying target biologics. “ a cell culture unit for generating target biologics in a volume of fluid ”: ‘584 discloses a bioreactor (bioreactor 1; Fig. 4; page 13, lines 35-38; page24; lines 1-4) that produces the particles such as a virus particle which is being interpreted as the target biologics of the instant application. “ a purification unit comprising a plurality of separators linked to the cell culture unit, each of the separators adapted for receiving at least a portion of the volume of fluid directly from the cell culture unit and purifying the target biologics in the corresponding portion of the volume of fluid ”: ‘5854 discloses a purification/filter unit that includes a concentrator (concentrator 2; Fig. 4; page 24 lines 1-4) which is a tangential flow filtration device (page 25 lines 16-26) and a clarification compartment (compartment 21; Fig. 4); page 26 lines 22-23) that includes a separator such as a chromatograph device (device 16; Fig. 4; page 26 lines 36-38; i.e. a chromatography column). Both of these devices are being interpreted as directly connected to the bioreactor and purify the fluid corresponding to the amount of fluid sent to each device. “ a collection unit for collecting the purified target biologics from the purification unit. ”: ‘584 discloses collection vessels such as a bulk vessel (vessel 28; Fig. 4; page 27 lines 19-21) and a decontamination vessel (vessel 8; Fig. 4; page 25 lines 17-26). ‘584 discloses a system for producing a biomolecule (Abstract) that includes the following limitations for claim 1 5 : “ A system for producing and purifying target biologics ”: ‘584 discloses a system for producing biomolecules (page 5 lines 28-32). The system of ‘584 is fully capable of purifying target biologics. “ means for generating target biologics in a volume of fluid ”: ‘584 discloses a bioreactor (bioreactor 1; Fig. 4; page 13, lines 35-38; page24; lines 1-4) that produces the particles such as a virus particle which is being interpreted as the target biologics of the instant application. The bioreactor of ‘584 is being interpreted as the equivalent structure as the means for generating of the instant application. “ means for serially purifying the target biologics in at least a portion of the volume of fluid received directly from the cell culture unit ”: ‘5854 discloses a purification/filter unit that includes a concentrator (concentrator 2; Fig. 4; page 24 lines 1-4) which is a tangential flow filtration device (page 25 lines 16-26) and a clarification compartment (compartment 21; Fig. 4); page 26 lines 22-23) that includes a separator such as a chromatograph device (device 16; Fig. 4; page 26 lines 36-38; i.e. a chromatography column). Both of these devices are being interpreted as directly connected to the bioreactor and purify the fluid corresponding to the amount of fluid sent to each device. Both of these are being interpreted as being serially in line with the bioreactor and are the art equivalent to the mans for purifying of the instant application. “ means for collecting the purified target biologics from the purifying means ”: ‘584 discloses collection vessels such as a bulk vessel (vessel 28; Fig. 4; page 27 lines 19-21) and a decontamination vessel (vessel 8; Fig. 4; page 25 lines 17-26). These tanks are being interpreted as the equivalent structure to the means for collecting. For claim 2, ‘584 discloses using a chromatography column (Fig. 4; page 11, lines 15-23) where this is being interpreted as the expanded bed of the instant application. For claim 3, ‘584 discloses using a chromatography column ( device 16; Fig. 4; page 26 lines 36-38; i.e. a chromatography column) which would use magnetic beads. For claim 6, the bioreactor of ‘584 is fully capable of operating in either perfusion mode or batch mode. For claim 7, the bioreactor of ‘584 is a stirred tank bioreactor (Fig. 4). For claim 8, the concentrator (concentrator 2) of ‘584 sends some of the volume back to the bioreactor (Fig. 4; page 25, lines 29-32). For claim 9, the concentrators of ‘584 are fully capable of sending some portion of the volume of fluid back to the bioreactor (page 25, lines 29-32; page 11, lines 15-16). For claim 16, ‘ 584 discloses a bioreactor (bioreactor 1; Fig. 4; page 13, lines 35-38; page24; lines 1-4) that produces the particles such as a virus particle which is being interpreted as the target biologics of the instant application. This bioreactor is the equivalent to the means for generating of the instant application. For claim 17, ‘584 discloses that the means for purification are a concentrator (concentrator 2; Fig. 4; page 24 lines 1-4) which is a tangential flow filtration device (page 25 lines 16-26) and a clarification compartment (compartment 21; Fig. 4); page 26 lines 22-23) that includes a separator such as a chromatograph device (device 16; Fig. 4; page 26 lines 36-38; i.e. a chromatography column). Both of these devices are being interpreted as directly connected to the bioreactor and purify the fluid corresponding to the amount of fluid sent to each device. Both of these are being interpreted as being serially in line with the bioreactor and are the art equivalent to the mans for purifying of the instant application. Furthermore, the two separators are being interpreted as being arranged in parallel. For claim 18, ‘584 discloses collection vessels such as a bulk vessel (vessel 28; Fig. 4; page 27 lines 19-21) and a decontamination vessel (vessel 8; Fig. 4; page 25 lines 17-26). These tanks are being interpreted as the equivalent structure to the means for collecting. Therefore, ‘584 meets the limitations of claims 1- 3, 6- 9 and 15-18. 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. Claim s 1 0-14 are rejected under 35 U.S.C. 103 as being unpatentable over Wolff et al. (EP 2966093 A1 – hereafter ‘093) in view of Ramsborg et al. (US 2017/0037369 A1 – hereafter ‘369) . ‘093 (Wolff) discloses a process for the preparation of magnetic sulfated cellulose particles (Abstract) that includes the following limitations for claim 10: “ A system for producing and purifying target biologics ”: ‘093 discloses a system for producing a biomolecule such as viral particles([0021]). “ a cell culture unit for generating target biologics in a volume of fluid ”: ‘093 discloses a bioreactor (Fig. 2; [0021]) that is used to culture the molecule and is therefore fully capable of generating a target biologic. “ a purification unit for receiving at least a portion of the volume of fluid from the cell culture unit and purifying the target biologics in the volume of t he fluid portion using magnetic beads adapted to bind the target biologics ”: ‘093 discloses using a magnetic separation device that separates the target molecule from the fluid by using magnetic beads ([0021]). “ a collection unit for collecting the purified target biologics from the purification unit. ”: While not specifying that a collection unit is present, the use of a collection unit to collect the molecule from the magnetic separation device is an intrinsic feature of ‘093 ‘369 (Ramsborg) discloses a system for culturing cells (Abstract) that includes using a chromatography column ([0047]) discloses for claim 1 using a collection vessel such as a waste container (container 10) or a culture vessel (vessel 12; Fig. 1A; [0047]). This allows further processing of the target molecule. Therefore, it would have been obvious to one of ordinary skill in the art to employ the vessels of ‘369 within ‘093 in order to collect the target molecule from the magnetic separator. The suggestion for doing so at the time would have been in order to carry out additional steps such as genetically engineering the cells or introducing a genetically engineered antigen receptor into the cells ([0019]). For claim 11, ‘093 discloses that the separator (Fig. 2; [0021]) returns a potion of the volume back to the bioreactor. For claim 12, ‘093 discloses at least one separator that is being interpreted as a chromatography column (Fig. 2; [0021]). For claim 13, the separator of ‘093 is in direct connection with the bioreactor (Fig. 2; [0021]). For claim 14, the separation unit of ‘093 is a magnetic separation unit and therefore has a magnet for attracting the beads. Claim s 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Castillo et al. (WO 2019/072584 A1 – hereafter ‘584) in view of Ramsborg et al. (US 2017/0037369 A1 – hereafter ‘369) . The following rejection of claim 3 is assuming, arguendo, that ‘584 (Castillo) does not explicitly or implicitly teach beads in the chromatography column. ‘584 (Castillo) differs from the instant claim regarding beads with an affinity to the target cell. ‘369 ( Ramsborg ) discloses a system for culturing cells (Abstract) that includes using a chromatography column ([0047]) discloses for claim 1 using a collection vessel such as a waste container (container 10) or a culture vessel (vessel 12; Fig. 1A; [0047]). ‘269 further discloses that the beads are coated with an antibody ([0145]) where this is being interpreted as the affinity of the instant application. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the affinity coated beads of ‘369 within ‘584 in order to separate the target molecule out of the fluid. The suggestion for doing so at the time would have been in order to have cells bid to a specific cell surface marker ([0013]). ‘584 differs from the instant claim 4. For claim 4, ‘369 discloses that the beads are magnetic ([0122]; [0123]) and that the beads are attracted to a magnet ([0123]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to employ the magnet and beads of ‘369 within ‘584 in order to separate a target molecule attached to the beads. The suggestion for doing so at the time would have been to have a way to separate out the target molecule, but retain the unlabeled molecules within the column ([0123]). ‘584 differs from claim 5 regarding the size of the beads. For claim 5, ‘369 discloses that the beads can have sizes of 50 m m , 60 m m , 70 m m , 80 m m , 90 m m , 100 m m , 120 m m , 150 m m or more ([0151]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to employ the bead size suggested by ‘369 within ‘584 in order to separate a target molecule from the fluid. The suggestion for doing so at the time would have been in order to have a bead sized that is below the maximal width of the target cell ([0151]). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lipkens et al. (US 2017/0191022 A1) discloses a bioreactor that uses an ultrasonic transducer. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MICHAEL L HOBBS whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3724 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Variable, but generally 8AM-5PM M-F . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Michael Marcheschi can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-1374 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MICHAEL L HOBBS/ Primary Examiner, Art Unit 1799