DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to filed provisions of the AIA .
2. Claims 1, 2, 4, 6, 8, 10, 12, 20-21, 27, 28, 38, 39, 41, 61, 88, 89, 91, 111-114, 116, 118-120, 122-124, 133-134, 136 and 138-143 are pending upon entry of amendment filed on 4/15/26.
Claims 38, 39, 41, 61, 88, 89 and 91 stand withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claim 1, 2, 4, 6, 8, 10, 12, 20-21, 27, 28, 111-114, 116, 118-120, 122-124, 133-134, 136 and 138-143 are under consideration in the instant application.
3. The following rejection remains.
4. 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 of this title, 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.
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.
5. Claim(s) 1, 2, 4, 6, 8, 10, 12, 20-21, 27, 28, 111-114, 116, 118-120, 122-124, 133-134, 136 and 138-143 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over EP3299380 (IDS reference, of record) in view of U.S. Pub. 2016/0370369 (of record) for the reasons set forth in the office action mailed on 1/16/26.
The ‘380 publication teaches methods of cleaning cation or anion exchange column material used in chromatography in antibody purification in acetate buffer and NaOH (p. 38). The ‘380 publication further teaches overloading mode of CD20 antibody produced in CHO and purification removes CHO host cell proteins. Given that the antibody is produced in CHO and purified by anion, cation, protein A using CaptoAdhere, Poros HS50, QSFF and sanitizing the columns with 77mM to 0.15M of acetate buffer at pH 5.5 and placement in sanitizing, claims 28, 111-114, 116, 118, 122-124, 133-134, 136 and 138-141 are included in this rejection. Moreover, the ‘380 publication teaches use of tris, NaOAc, 0.1N NaOH in stripping, storage buffer (p.11) and pH of 4-11 in column volume from 5-50 (p. 11, Figures).
In addition, the ‘380 publication teaches use of 5CV or storage solution of 0.1N NaOH so this would expect to consist of pH of 8.3 and claims 4 and 12 are included. Also, passing through 100cm/hr of chromatographic column and mixed mode chromatography is taught (p. 40). The CaptoAdhere and Poros HS50 and QSFF read on column material and claims 119-120 are included.
Applicant is reminded that although the term regeneration buffer is missing, the strip buffer 2 as in p.41 of the ‘380 publication read on the claimed regeneration buffer as it was passed through after elution, washing and stripping 1. IN addition, sanitization of 0.5N NaOH was performed right after Strip1 and storage was done with 0.1N NaOH required by the claimed invention in step (c).
The disclosure of the ’380 publication differs from the claimed invention in that it does not teach “passing of sanitization buffer through ion exchange chromatography material as the next step following step (a) as currently amended by claim 1 of the instant application.
The ‘369 publication teaches use of about 50mM of sodium acetate buffer after elution gradient in washing, regeneration and storage with 0.5N NaOH and 0.1N NaOH (Tables 8-9, p. 40-42). The ‘369 publication in Fig 2 discloses that the high wash eluted all the impurities and continuous chromatographic steps (p. 12-13) may be helpful in yielding efficient purifications.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize continuous steps of sanitization and washing continuously as taught by the ‘369 publication into the purification methods taught by the ‘380 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because continuous steps may lead more efficient purifications of antibody or proteins while removing impurities.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicant’s response filed on 4/15/26 has been fully considered but they were not persuasive.
Applicant has asserted that combination of the references is not obvious in that the teachings of the ‘369 publication is outside the scope of the claimed method as the ‘369 publication involves a relatively low loading density.
However, in lack of definition of overload mode, loading greater than 150g/L upto 600g/L is taught by the ‘380 publication (p. 42). The passing high salt wash or regeneration buffer that is readable within the claimed buffer. Applicant is advised to recite specific overload condition, nature of column materials, load density and specific flow rate that is suitable for claimed method.
6. No claims are allowable.
7. THIS ACTION IS MADE FINAL. 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.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
June 11, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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