DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/6/26 has been entered.
3. Claims 1, 7-18, 26, 34-36, 39 and 47 are pending upon entry of amendment filed on 2/6/26.
Claims 18, 26, 34-36 and 39 stand withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claim 1, 7-17 and 47 are under consideration in the instant application.
4. The following rejection remains.
5. 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 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.
6. 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.
7. Claims 1, 7-17 and 47 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pat 8,529,902 (of record) in view of U.S.Pub 2006/0088523 (of record) for the reasons set forth in the office action mailed on 11/7/25.
The ‘902 patent teaches CD20 antibody formulation comprising the claimed SEQ ID NO:1-4 (note claims and SEQ ID NO:2 and 4). The ‘902 patent further teaches the composition may comprise phosphoric acid, sucrose and the antibody may be produced in CHO (note col. 14, 36-38).
Although the patentability does not rely the method of the production unless the production method results in structurally different product, the prior art CHO is deemed identical to the claimed CHO, claims 7-9 are included in this rejection as the characteristics recited in claims 7-9 are expected.
The disclosure of the ‘902 patent differs from the instant claimed invention in that it does not teach the use of 10-30mM buffer, 80-240mM of stabilizer and 0.1-0.4mg/ml of surfactant as in claim 1 of the instant application.
The ‘523 publication teaches the use of formulation comprising 10-30mM of histidine buffer at pH 5.5-6.2, saccharide comprising sucrose and trehalose at 60-250mM and polysorbate at 0.02% (claims, Examples) in stabilizing antibody and the formulation stabilizes CD20 antibody.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the formulation comprising histidine, sucrose and polysorbate stabilizes CD20 antibody as taught by the ‘523 publication into the CD20 antibody set forth for SEQ ID NO:1-4 taught by the ‘902 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the formulation comprising histidine, sucrose and polysorbate is known to stabilize CD 20 antibody and it is expected to stabilize CD20 antibody set forth in SEQ ID NO:1-4 and improve stability by reducing aggregates.
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 2/6/26 has been fully considered but they were not persuasive.
Applicant has asserted that the combination of the references is not obvious based on the exhibited reference of ‘300 publication and formulations disclosed in Examples and tables.
Applicant has further asserted that the ‘300 publication discloses the same formulation exhibit different stability profiles for variants of CD20 antibody and the specification exhibit unexpected properties of monomer contents under 40oC.
Further, the recitation of the currently amended claims obviates the rejection of the record.
However, the ‘523 publication is remained as a proper secondary reference teaching acetate and histidine buffer in claim 1 and stabilizer. Given that the combination of stabilizer and buffer in the presence of surfactant is taught by the ‘523 publication, the liquid formulation having at least 90% monomer purity after storage at 40oC for 4 weeks determined by size exclusion chromatography is an expected property. If assertation of unexpected property is required, the specific unexpected property needs to be recited. Indeed, the ‘523 publication defines the stability as “being stable at 40oC for 4 weeks” in p. 7. As such, the currently amended limitations is deemed an expected property of composition comprising acetate buffer, sucrose, and polysorbate at a combination of concentration recited by claim 1 of the instant application.
As discussed previously, Applicant is reminded that obviousness does not require absolute predictability, but at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support conclusion of nonobviousness. See MPEP2143.02. Although the ‘300 publication shows different stability profiles for variant antibodies with the same formulation, the conditions monitoring the stability (e.g. aggregation after 16 days of storage at 40oC) has not been incorporated in claims. Applicant is advised to recite conditions to exhibit stability at 40oC as in p. 55-56 of the instant specification.
8. No claims are allowable.
9. 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.
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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
February 11, 2026
/YUNSOO KIM/
Primary Examiner, Art Unit 1641