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. Claims 1, 4-7, 9, 10, 37-40, 42-46, 48, 49 and 58-79 are pending upon entry of amendment filed on 10/10/25.
Claim 1, 4-7, 9, 10, 37-40, 42-46, 48, 49 and 58-79 are under consideration in the instant application.
3. Applicant’s submission of IDS filed on 10/10/25 has been considered.
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. Claim 1, 4-7, 9, 10, 37-40, 42-46, 48, 49 and 58-79 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2006/0051347 (IDS reference, of record) in view of WO2008/071394 (IDS reference, of record) and EP2583980 (IDS reference, of record) for the reasons set forth in the office action mailed on 4/11/25.
The ‘347 publication teaches preparation of antibody formulation comprising ultrafiltration of antibody in histidine buffer at pH 6, diafiltration in rinse buffer comprising TRIS and ultrafiltration in histidine and trehalose (example 1-2, 4 and Table 10). The ultrafiltration and diafiltration steps inherently include adding antibody, excipients/ buffer in retentate from the previous filtrations as noted in Examples 2-4. Additionally, given that the antibody formulations are being concentrated each filtration steps, it meets the limitations of being “enhanced” recovery as in claim 2. The concentrations of antibody is about 170g/l (claims 10-15), buffer includes about 25mM TRIS, 200mM arginine and 0.02% polysorbate.
Further, the ‘347 publication teaches ultrafiltration conditions, diafiltration membranes and additions of excipients ([0060-0094]).
The ‘394 publication teaches purification of antibody comprising ultrafiltration in 20mM of histidine, diafiltration in presence of 125mM of sucrose and ultrafiltration. The ‘394 publication further teaches the final bulk composition of 10mM histidine, 125mM sucrose or NaCl 0.02% Tween at pH 6.5 after the processes. The filtration processes yielded 100-200fold of concentrated antibody (p. 25-26).
The disclosure of the ‘437 and 394 publication differs from the instant claimed invention in that it does not teach the use of IL-7R antibody as in claims 34-54 of the instant application.
The ‘980 publication teaches preparation of IL-7R antibody set forth in SEQ ID NO:13-14 and the needs for IL-7R antibody. The antibody is beneficial in treatment of autoimmune diseases such as multiple sclerosis and shows ability to eliminate malignant cells in lymphomas (p. 3-6, 9-13).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize IL-7R antibody into the antibody preparation methods taught by the ‘437 and 394 publications comprising sequential steps of ultrafiltration, diafilatration and ultrafiltration with specific conditions taught by the ‘437 and 394 publications.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the known antibody purification or concentration processes may be applicable to the therapeutically important antibody such as IL-17R antibody in bulk or concentrated preparation.
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 10/10/25 has been fully considered but they were not persuasive.
Applicant has asserted that both ‘347 and ‘394 publications are not available as anticipatory reference and the combination of the references does not result in the claimed invention. Applicant has further asserted that the ‘394 publication describes a method of preparing an antibody formulation by concentrating an antibody by ultrafiltration, diluting, buffer exchange against diafiltration followed by concentration. IN addition, Applicant has asserted that the previously withdrawn rejections of 35 USC 102(a)(1) are based on the references of record and the prima facie obviousness has not been established.
Moreover, Applicant has asserted that there is no motivation to combine the references as the conventional method involves final ultrafiltration and highly concentrated formulation results in viscous solution. The current method cannot concentrate with excipient spike formulations and the claimed method may target trehalose of 84g/L in the final formulation; the larger batch of 187.5g/L of antibody concentration was achieved without high viscosity.
Applicant has asserted that the ‘347 publication uses different approaches and highly concentrated antibody was carried at ambient temperature and the concentration of antibody is about 104g/L resulting viscous solution and the higher temperature range was used during the ultrafiltration.
However, unlike Applicant’s assertion, the claimed invention recited in claim 1 does not require performing ultrafiltration at room temperature, accessing 184g/L after ultrafiltration and/or has low viscosity for further processing. IN lack of specific concentration, specific spike solution comprising sugar and/or specific viscosity, the teachings of the ‘347 or 394 publication meet the claimed invention. As Applicant acknowledges, the ‘347 publication performs ultrafiltration-diafiltration and ultrafiltration required by the currently amended claim 1 (note response p. 11).
As discussed previously, the references remain as prior art. The ‘347 publication reveals the 50mM of the histidine and 150mM trehalose with 0.02% polysorbate at 20 was obtained after diafiltration ([0114]) and the continuous sequential ultrafiltration, diafiltration and second filtration is taught in claims. IN addition, upon the first ultra-filtration, the pool is concentrated and this is being diafiltered (Examples). Note table 21 of the ‘347 publication discloses recovery pool of 187g/L.
Further, the ‘394 publication teaches addition of sugar (sucrose of 125mM) after diafiltration (note p. 26) and concentrated by ultrafiltration.
The deficiency is cured by the ‘980 publication for the reasons set forth in the office action mailed on 4/11/25. Applicant argues that the limitations that are not recited. Applicant is advised to recite specific temperature, final viscosity or starting or ending concentration of ultrafiltration, diafiltration and ultrafiltration of antibody, excipient concentrations as recited in claims 64-78 in claim 1 to obviate the rejection. Unless, the combination of reference remains obvious and the rejection is maintained.
8. The following new ground of rejection is necessitated by Applicants’ amendment filed on 10/10/25.
9. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
10. Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim recites improper Markush Group. Applicant is required to use “is selected from the group consisting of A, B, C and D” format. Appropriate correction is required.
11. No claims are allowable.
12. 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.
13. 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 on Mon-Fri 8:30-5. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-. 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
November 6, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641