3Notice 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 .
Detail Action
Claims 1-14 submitted on 2/29/2024 are pending for examination.
Claims 1- 14 will be examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/28/2024, 6/25/2024 , 6/25/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the IDS statement.
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.
Claims 1- 14 are rejected under 35 U.S.C. 103 as being unpatentable over D1: CN113150149 (IDS, priority 06/19/2020 to CN202110189508.0A) in view of in view of Oppenheim et.al, ( WO2020/25072 , IDS), Ameli et al. ( Wo2020(252069A1, IDS).
D1: CN113150149 discloses a purification method for anti-IL-17RA monoclonal antibody. The method comprises affinity chromatography, cation exchange chromatography and anion exchange chromatography (abstract). Paragraph 0024 discloses the purification method for an anti-IL-17 RA monoclonal antibody, which not only reduces the process impurities such as host protein (HCP), protein-A, DNA, and the like in antibody protein based on ensuring the protein quality by a three-step chromatography method, but also simplifies the operation process, does not need to independently regulate proper pH value again in the transition process from cation exchange chromatography to anion exchange chromatography, has smooth two-step connection, avoids introducing impurities in the process of regulating the pH value, shortens the purification period, improves the purification efficiency, saves time for the pilot-scale production in the later period. From claim 1 it is clear that the first step in purification is affinity chromatography (s1), second is cation exchange chromatography (s2), and third anion exchange chromatography (s3). D1 also devoid of hydrophobic interaction chromatography. Example 14 discloses antibody recovery rate of 96-99.9%. Example 12 has a significant effect of removing residual HCP and DNA and simultaneously removing acidic isomers. D1 is considered to be the closest prior art for the subject matter of claims 1-14. Both D1 and the present application relate to same field i.e process to reduce impurities in antibody composition by using three-step chromatography. The subject matter of claims 1-14 of instant application differs from D1 in view of specific antibody claimed.
CN113150149 does not teach purifying specific antibody anti-α4β7
claimed in instant claims.
Oppenheim et al. teaches contacting a solution comprising a4ß7 antibodies, along with impurities, by using cation exchange chromatography (CEX; page 6, lines 7-9). The matrix is then washed with a wash solution and the a4ß7 antibodies are eluted with a solution having a conductivity below 14 mS/cm (page 6, lines 28-29) and a pH of about 5-6 (page 7, lines 1-2). See also claims 38, 40, 44. Oppenheim teaches that cation exchange chromatography (CEX comprised charged group similarly AEX also comprises Charged group, (Teach applicants claims 11-12.).
Ameli et al teach that a primary recovery precedes the AEX unit operation, wherein the primary employs pH reduction, centrifugation and filtration steps to remove cells and cell debris from the bioreactor harvest (Ameli, p 32, lines 24-32). Ameli also teaches that one such filtration process is tangential flow filtration (Ameli, p 35, lines 27-34).
Ameli does not explicitly teach that the antibody composition is subjected to a tangential flow filtration step prior to contacting with the AEX resin.
It would be prima facie obvious to one of ordinary skill in the art to subject the antibody solution of Ameli to a TFF step prior to contacting the antibody solution of Ameli with the AEX resin. One of ordinary skill in the art would be motivated to do this in order to remove the cells and cell debris from the solution prior to contacting the solution with the AEX resin. One of ordinary skill in the art would have a reasonable expectation of success subjecting the solution of Ameli to a TFF step prior to contacting the antibody solution of Ameli with the AEX resin to remove the cells/cell debris because Ameli teaches that a filtration step is performed prior to contacting the antibody solution of Ameli with the AEX resin to remove cells/cell debris and TFF is one of the filtration methods taught by Ameli obvious over applicants claim 13-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of instant application combine the CN113150149 (IDS, priority 06/19/2020 to CN202110189508.0A), Oppenheim et.al, ( WO2020/25072 , IDS), and Ameli et al. ( Wo2020(252069A1, IDS ) to use the method of CN113150149 wherein said method comprises affinity chromatography, cation exchange chromatography and anion exchange chromatography for the purification an anti-IL-17 RA monoclonal antibody instead purify anti-α4β7 as taught by Oppenheim et.al, ( WO2020/25072 , IDS), and Ameli et al. ( Wo2020(252069A1, IDS ) which results arriving the claimed invention of instant claims 1-14. One would have been motivated to and would have had a reasonable expectation of success because CN113150149 purify an anti-IL-17 RA monoclonal antibody and Oppenheim et.al or Ameli et al. teach anti-α4β7 by chromatography procedures.
Conclusion
Claims 1-14 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMAD Y MEAH whose telephone number is (571)272-1261. The examiner can normally be reached on monday-friday (8-7).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 4089187584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMAD Y MEAH/ Examiner, Art Unit 1652
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