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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 7, 10-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2014/0299547 by Muller-Spath et al. (Muller-Spath) in view of U.S. Patent Publication No. 2013/0213884 by Lacki (Lacki).
In regard to claim 7, Muller-Spath teaches a method for determining an optimum operating binding capacity for a multiple column chromatography process (abstract). Muller-Spath teaches connecting at least two columns of equal size in series (abstract). Muller-Spath teaches loading a target product on the at least two columns at a constant flow rate (abstract; [0005]-[0007]; [0013]). Muller-Spath teaches determining the optimum operating binding capacity for the MCC process ([0004]-[0007]; [0014]; [0034]; [0184]; Table 10; [0202]-[0207]).
Muller-Spath does not teach providing predetermined residence times through the at least two columns. Muller-Spath teaches loading or generating breakthrough curves based on a flow rate. Muller-Spath teaches the chromatography column has a column volume ([0201]).
Lacki teaches a method of chromatography (abstract). Lacki teaches that residence time is the ratio between column volume and feed flow rate ([0003]). Lacki teaches that binding capacity represents a breakthrough capacity of the column when the residence time is infinitely long ([0003]).
It would have been obvious for one ordinary skilled in the art before the effective filing date to base the loading and generating on residence time, as taught by Lacki, as residence time, column volume, and flow rate are directly related to one another in chromatography. One of ordinary skill in the art would recognize that residence time is merely the ratio of the column volume and flow rate.
Muller-Spath teaches the at least two columns comprise a first column and a second column (abstract). Muller-Spath teaches loading a target product on columns at flow rates ([0059]; [0202]-[0207]; [0005]-[0007]).
Lacki teaches the predetermined residence times comprise a first residence time; Lacki teaches loading the target product at a residence time ([0003]). The combination of Muller-Spath teaches multiple columns and multiple residence times.
In regard to claim 10, Muller-Spath teaches generating breakthrough curves for the first residence time and the one or more additional residence times (series of breakthrough curves of a single column, [0059]; feed flow rate , Qfeed, IC, lower batch step feed flow rate Q feed, B, [0005]-[0007]; Table 10; [0202]-[0207]). Muller-Spath teaches the breakthrough curves represent target product breakthrough as a function of target product concentration versus time ([0059]). Muller-Spath teaches determining the optimum binding capacity for the MCC process from the breakthrough curves ([0004]-[0007]; [0184], Table 10, [0202]-[0207]).
In regard to claim 11, Muller-Spath teaches a number of the at least two columns is two and determining the optimum operating binding capacity for the MCC process from the breakthrough curves comprises using the breakthrough curves to determine target product loading capacity of the first column before target product breakthrough at the second column ([0059]). Muller-Spath teaches the target product loading capacity of the first column equals the optimum operating binding capacity for the MCC process ([0059]).
In regard to claim 13, Muller-Spath teaches a number of the at least two columns is N and determining the optimum operating binding capacity for the MCC process from the breakthrough curves comprises using the breakthrough curves to determine target product loading capacity of the first column before target product breakthrough at the Nth column ([0059]). Muller-Spath teaches the target product loading capacity of the first column equals the optimum operating binding capacity for the MCC process ([0059]).
Response to Arguments
Applicant's arguments filed 12/8/2025 have been fully considered but they are not persuasive.
In regard to the Applicant’s argument the features were surprisingly found to provide significant advantage, the multi-phase load did not have an effect on the capacity of the column or upon breakthrough of the target product from the column; loading less target product results in less-than-optimal column utilization; the Examiner does not find this persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., did not have an effect on the capacity of the column or upon breakthrough of the target product from the column; loading less target product results in less-than-optimal column utilization) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In regard to the Applicant’s argument Lacki does not teach performing multiple predetermined residence times on the two column series; Lacki is directed to a three column arrangement with guard columns to improve capacity utilization; Lacki is not directed towards “optimum operating binding capacity”; Lacki mentions residence time but this does not supply a teaching or reason to redesign Muller-Spaths protocol into the claimed residence-time sweep on the multi-column assembly; Lacki imports generic background definitions without a teaching or motivation and is a result of improper hindsight reconstruction; Lacki’s disclosure uses detectors and there is no suggestion to generate series of breakthrough curves at multiple residence times or to derive an optimum from them, the Examiner does not find this persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Muller-Spath teaches the column configuration and a method for determining an optimum operating binding capacity. Muller-Spath teaches generating breakthrough curves. Further, the claims are directed towards “at least two columns” and thus a three column system is not excluded.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). It would have been obvious for one ordinary skilled in the art before the effective filing date to base the loading and generating on residence time, as taught by Lacki, as residence time, column volume, and flow rate are directly related to one another in chromatography. One of ordinary skill in the art would recognize that residence time is merely the ratio of the column volume and flow rate.
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.
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/KARA M PEO/Primary Examiner, Art Unit 1777