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 .
Claims 1-8 are pending and will be examined on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities:
There should be a colon after “comprising the steps of”.
Appropriate correction is required.
Claim 7 is objected to because of the following informalities:
Claim 7 recites “wherein the pH and conductivity of the wash buffer solution and the loading buffer solution is the same” when it should read “wherein the pH and conductivity of the wash buffer solution and the loading buffer solution are the same”.
Appropriate correction 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.
Claim(s) 1-2 and 5-7 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ameli (Ameli, et al., WO 2020/252069A1; Published 12/17/2020).
Ameli teaches methods of purifying an anti-alpha4Beta7 integrin antibody that is vedolizumab (Ameli, Abstract). Regarding claims 1-2 and 5-6, Ameli teaches a separation method wherein vedolizumab is contacted with an AEX resin in the presence of a loading buffer and is collecting the flow-through material (Ameli, p 55, lines 10-18), wherein the conductivity of the loading buffer is about 5 mS/cm (Ameli, p 56, lines 21-26), a pH of about 7.0 (Ameli, p 57, line 8) and sodium phosphate (Ameli, p 57, lines 3-6). Regarding claim 7, Ameli teaches wash buffers having the same conductivity (Ameli, claim 75) and pH (Ameli, claim 109).
Claim Rejections - 35 USC § 102/103
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.
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) 3-4 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ameli (Ameli, et al., WO 2020/252069A1; Published 12/17/2020).
The separation scheme of Ameli is discussed above.
Regarding claim 3, Ameli is silent that the method of Ameli would reduce HMW aggregates by at least 50% compared to before loading onto the AEX support. However, as evidenced by the instant Specification it would be expected that performing the method of Ameli (Specification at page 5, lines 13-19), would inherently reduce HMW aggregates by at least 50% compared to the composition loaded onto the AEX support (Specification, p 6, lines 21-24).
Regarding claim 4, Ameli is silent that the method of Ameli would result in antibody recovery in the flow through that is 95% or more. However, as evidenced by the instant Specification it would be expected that performing the method of Ameli (Specification at page 5, lines 13-19), would inherently result in antibody recovery in the flow through that is 95% or more (Specification, p 7, lines 10-11).
Claim Rejections - 35 USC § 103
Claim(s) 1-2 and 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ameli (Ameli, et al., WO 2020/252069A1; Published 12/17/2020) as applied to claims 1-2 and 5-7 and above and in further consideration of the Ameli reference.
The teachings of Ameli are discussed above. In addition to the teachings of Ameli discussed above, Ameli teaches 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.
Conclusion
Claims 1-8 are rejected.
Claims 1 and 7 are objected to.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sydney Van Druff whose telephone number is (571)272-2085. The examiner can normally be reached 10 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SYDNEY VAN DRUFF/ Examiner, Art Unit 1643
/JULIE WU/ Supervisory Patent Examiner, Art Unit 1643
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