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 .
Election/Restrictions
Applicant’s election without traverse of Group I (i.e., a single use system for integrated, continuous processing of an initial biologic product, wherein the system comprises a viral filtration unit coupled to a SPTFF and DF unit operation) in the reply filed on 04/09/2026 is acknowledged.
Claims 47-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of Claims
Claims 33-51 are currently pending.
Claims 33-46 are under consideration, as claims 47-51 are withdrawn.
Priority
The present application claims status as a 371 (National Stage) of PCT/US2022/030783 filed on 05/24/2022. Acknowledgment is made of applicant’s claim for benefit under 35 U.S.C. 119(e) of Provisional application No. 63/192,662, filed on 05/25/2021. The present application and all claims are being examined with an effective filing date of May 25, 2021. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/17/2023 and 07/03/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112(b)
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 applicant regards as his invention.
Claim 38 is 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.
Claim 38 is indefinite due to the recitation of “the SPTFF-DF unit operation comprises one or more SPTFF membranes, DF mixing tanks, DF membranes, sensors, pumps or a combination thereof.” It is unclear whether the phrase “one or more” modified only the immediately following term “SPTFF membranes” or instead modified each of the subsequently recited components or the recited group as a whole. Additionally, it is unclear which of the recited components are required to be present in order to constitute the claimed SPTFF-DF unit operation, because the phrase “or a combination thereof” renders the scope of the claim uncertain as to whether the claimed unit operation requires all of the recited components, one or more of the recited components, or any combination of the recited components. Accordingly, the metes and bounds of the claimed invention cannot be determined with reasonable certainty. For examination purposes, the examiner is interpreting the phrase “one or more” as applying to the entire subsequently recited group of components, such that the claim is interpreted as requiring one or more components selected from the recited group of SPTFF membranes, DF mixing tanks, DF membranes, sensors, and pumps.
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 33-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coolbaugh et al. (WO2020205928, cited in the IDS).
Regarding claims 33-36, Coolbaugh et al. discloses systems using capture chromatography, post-capture chromatography, virus filtration, and ultrafiltration/diafiltration for the continuous production of recombinant proteins (Abstract). In particular, Coolbaugh et al. discloses a manufacturing system comprising a plurality of operation units, including post-capture chromatography, virus filtration, ultrafiltration, and diafiltration, configured for integrated and continuous processing (para 0020-0022). Coolbaugh et al. also teaches that the virus filtration subsystem employs a single-use closed and sterilizable pressure vessel (para 0051). In an exemplary system, Coolbaugh et al. discloses that the virus filtration operation was integrated with the preceding unit operations and operated continuously. The virus-filtered material was subsequently processed via single-pass tangential flow filtration (SPTFF) to concentrate monoclonal antibody, after which the concentrated stream was pumped directly to a single-pass diafiltration (SP-DF) cassette to perform in-line buffer exchange, with the formulated bulk collected in a single-use vessel (Example 1, para 0067-0068). Therefore, Coolbaugh et al. discloses a single use system comprising a viral filtration unit operation coupled to SPTFF and diafiltration unit operation, as recited in claim 33 (see also Fig. 6A).
Regarding claim 37, Coolbaugh et al. discloses the single-use system of claim 33, as described above, wherein the viral filtration unit operation comprises a pump, at least one pre-filter and one or more viral reduction filtration membranes. Figure 6A illustrates the virus filtration system including a feed pump, a sterilizing grade pre-filter positioned upstream of the virus removal filter, and a virus removal filter comprising viral filtration membranes (see Fig. 6A; para 0051).
Regarding claim 38, Coolbaugh et al. disclose the single-use system of claim 33, wherein the SPTFF-DF unit operation comprises one or more - SPTFF membranes, DF mixing tanks, DF membranes, sensors, pumps, or combinations thereof. Figures 1 and 7A-8E disclose an integrated SPTFF and diafiltration system including SPTFF membranes, diafiltration membranes, pumps, in-line monitoring sensors, and buffer addition for diafiltration (Figs. 1, 7A-8E; paras 0041-42, 0068).
Regarding claim 39, Coolbaugh et al. discloses the single-use system of claim 33 further comprising a feed reservoir coupled to the viral filtration unit operation. Specifically, Figure 6A illustrates a feed reservoir (i.e., “vessel”) positioned upstream of the virus removal filter and coupled to the virus filtration unit operation (see Fig. 6A; para 0051).
Regarding claims 40-41, figure 6A identifies the feed stream entering the feed reservoir of the virus filtration unit as the feed stream after polishing and figure 5B reports the protein concentration of the post-capture (polished) monoclonal antibody stream. Therefore, Coolbaugh et al. discloses the single-use system of claim 39, as described above, wherein the feed reservoir holds purified and polished monoclonal antibody at a concentration between about 5 and about 20 g/L, and more specifically between about 8 and about 12 g/L (Fig. 5B). Coolbaugh et al. do not disclose any intervening concentration or dilution operation between the post-capture polishing operation and the feed reservoir, therefore, a person of ordinary skill in the art would have understood the protein concentration reported for the post-capture polished monoclonal antibody stream in Figure 5B to represent the concentration of the polished feed stream entering the feed reservoir illustrated in Figure 6A, including concentrations falling within the recited ranges (Figs. 5B and 6A; para 0065-68).
Regarding claims 42-45, Coolbaugh et al. discloses the single-use system of claim 33, wherein the system performs integrated, continuous viral filtration, concentration, and buffer exchange within about 24 hours or less, within about 12 hours or less, within about 8 hours or less, and within about 8 hours. Specifically, Figure 2B discloses the average protein residence time for the integrated downstream processing operations. Figure 2B shows that viral filtration requires approximately 2 hours and the subsequent ultrafiltration/diafiltration concentration and buffer exchange operation requires approximately 4 hours, for a combined processing time of approximately 6 hours for the recited operations. Accordingly, Coolbaugh et al. discloses performing the claimed integrated, continuous viral filtration, concentration, and buffer exchange within each of the recited time periods. (Fig. 2B; para 0010).
Regarding claim 46, Coolbaugh et al. discloses the single-use system of claim 33, wherein the system is capable of processing a ten-fold increase in the concentration of the biologic product. Figure 6B discloses the monoclonal antibody concentration following viral filtration to be approximately 6–10 g/L. Coolbaugh et al. further discloses concentrating the product during the subsequent single-pass ultrafiltration operation to a target monoclonal antibody concentration of approximately 65 g/L, as shown in Figure 7A and described in paragraph 0068. Thus, a person of ordinary skill in the art would have understood Coolbaugh et al.’s disclosed system to be capable of processing a ten-fold increase in the concentration of the biologic product, as recited. (see Figs. 6B and 7A; para 0068).
Thus, claims 33-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the subject matter disclosed and taught by Coolbaugh et al.
Conclusion
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAGHMEH NINA MOAZZAMI whose telephone number is (703)756-4770. The examiner can normally be reached Monday-Friday, 9:00-5:00.
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/NAGHMEH NINA MOAZZAMI/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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