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 .
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] needs to be updated because the instant Application is the National Stage of a PCT application.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yehl et al (2018 Journal of Membrane Science vol 633, No 119396, 7 pages) in view of Schwan et al (US 10,421,042 B2) and Becker et al (WO 2014/067898).
Yehl et al teach counter current dialysis in which the product is (slightly concentrated (page 3, right column, lines 3-8). Yehl et al teach that the first and second flow rates are 3.97 mL/min and 3.74 mL/min. Yehl et al teach that the dialysate in-flow rate is 9.0 mL/min (thus the dialysate in-flow rate is about 3-4 time the first flow rate). Yehl et al teach as the mass balance must be constant, it is clear that the dialysate out-flow must be the sum of the dialysate in-flow and the difference between the first and second flow rates.
Schwan et al teach that purification of biopharmaceuticals and biological macromolecular products using a counter-current ultrafiltration unit (see Figure 1) using a capillary ultrafiltration membrane and teaches using 10 mL/min feed and a 30 mL/min buffer rates. Schwan et al teach using the system to purify IgG from a fermenter broth in Table B at column 12. Thus, the use of a counter-current ultrafiltration unit to purify an antibody as recited in instant claims 14-17 would have been routine in the art before the effective filing date of the instant claims.
Neither Yehl et al or Schwan et al teach multiple dialysis cassettes.
Becker et al teach a dule state tangential-flow ultrafiltration system to purify an antibody at claims 1 and 8.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claims to modify the teachings of either Yehl et al and/or Schwan et al using the teachings of Becker et al to use multiple tandem dialysis cassettes to purify an antibody product from a bioreactor (instant claim 12). Further, it would have been obvious to optimize flow rates, in fact Schwan et al teach such optimization in Table A at columns 11-12. Finally, the production rate of instant claim 13 is directed to a desired outcome that is directly related to the optimization of the counter-current dialysis process.
Given the success of Schwan et al and Becker et al, one of ordinary skill in the art would have had a reasonable expectation of success in using tandem counter-current ultrafiltration units that are flow optimized for a desired outcome. It is Becker et al who motivates/suggests using tandem ultrafiltration units.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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/David H Kruse/
Primary Examiner, Art Unit 1663
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