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 .
Claim Status
Applicant’s amendments and remarks, filed 10/06/2025, are acknowledged.
Claims 1-18, 25-26, and 35-36 are canceled.
Claims 19-24, 27-34, and 37-38 are amended.
Claims 46-58 are new.
Claims 19-24, 27-34, and 37-58 are pending.
Claims 38-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/13/2025.
As such, claims 19-24, 27-34, 37, and 46-58 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Terminal Disclaimer
The terminal disclaimer filed on 10/06/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent Nos. 11807689, 11814439, 11884740, and 11965032; and, any patent granted on Application Number 18/597,711 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Objections
The specification objections are withdrawn. Issues regarding minor informalities and trademarks/names have been sufficiently addressed through amendments to the specification on 10/06/2025.
Withdrawn Rejections
Applicant’s arguments, see pages 14-16, filed 10/06/2025, with respect to claims 19-37 rejected under 35 USC 112(b) as allegedly being indefinite have been fully considered and are persuasive in part. The issue regarding the claims comprising indefinite language have been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 25-26 and 35-36 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(b) is withdrawn.
Applicant’s remarks, see pages 16-21, filed on 10/06/2025, with respect to claims 19-24 and 28-34 rejected under 35 USC 103 as allegedly unpatentable over de Romeuf, as evidenced by Abdelwahed, DrugBank.com – Ublituximab, Dekkers, CDER Application Number: 761103Orig1s000 Product Quality Review(s), Rituxan (rituximab) FDA Labeling, and GAZYVA® (Obinutuzumab) FDA Labeling; and, claims 19-37 rejected under 35 USC 103 as allegedly unpatentable over de Romeuf, as evidenced by Abdelwahed, DrugBank.com – Ublituximab, Dekkers, Center for Drug Evaluation and Research (CDER) Application Number: 761103Orig1s000 Product Quality Review(s), Rituxan (rituximab) FDA Labeling, GAZYVA® (Obinutuzumab) FDA Labeling, European Medicines Agency “EMA”, Kelley, Reusch, and Carillo have been fully considered and are persuasive. Examiner acknowledges that claims 25-26 and 35-36 are canceled, thus rendering the rejection moot. Further, Examiner agrees with Applicant’s argument that the pertinent art fails to teach or suggest a population of anti-CD20 antibody proteins as described by the present claims. As such, the rejections under 35 USC 103 are withdrawn.
Applicant’s arguments, see pages 21 and 22, filed 10/06/2025, with respect to claims 19-37 rejected on the grounds of nonstatutory double patenting of US Patent Nos. 11807689, 11814439, 11884740, and 11965032 have been fully considered and are persuasive. Examiner acknowledges that Applicant submitted a terminal disclaimer for US Patent Nos. 11807689, 11814439, 11884740, and 11965032 filed 10/06/2025.
Applicant’s arguments, see pages 20 and 21, filed 10/06/2025, with respect to claims 19-37 provisionally rejected on the grounds of nonstatutory double patenting of copending Application No. 18/597,711 have been fully considered and are persuasive. Examiner acknowledges that Applicant submitted a terminal disclaimer for copending Application No. 18/597,711 filed 10/06/2025.
Maintained Rejections
Claim Rejections - 35 USC § 112(b)
Claim 37 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 37 recite the broad recitation “at least 100 g”, and the claims also recite “at least 120 g, or at least 150 g”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Applicant’s Arguments
Applicant states that claim 37 was amended such that the claim recites a single and distinct range. See page 16 of the Remarks filed on 10/06/2025.
Response to Arguments
Applicant's arguments filed 10/06/2025 have been fully considered but they are not persuasive. Examiner acknowledges that claim 37 was amended to remove the narrow limitation “less than 5% , or less than 1%”; however, the claim still recites “at least 120 g, or at least 150 g” which is the narrower limitation of “at least 100 g”. As such, the 112(b) rejection is maintained.
New Objections and Rejections Necessitated by Amendment
Claim Objections
Claims 30 and 52 are objected to because of the following informalities:
Claims 30 and 52: “dehydrate” should read “dihydrate”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 27, 49, and 56 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 was amended to end with the term “and/or”. This renders the scope of the claim indefinite because there is no alternative following the term, thus one would not know what the alternatives are.
Claims 49 and 56 recite the limitation "the bisecting N-glycans" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Allowable Subject Matter
Claims 19-24, 28-29, 31-34, 46-48, 50-51, 53-55, and 57-58 appear to be free of the art. The closest prior art is Faid et al. (WO 2013/021279 A2, publication date: 02/14/2013). Faid et al. teach of antibodies that are highly galactosylated (see Abstract). Faid et al. teach that these highly galactosylated antibodies show both high complement dependent cytotoxicity (CDC) activity and high antibody-depended cellular cytotoxicity (ADCC) activity (see pg.1, lines 21-23). Faid et al. teach of a composition comprising a population of antibodies wherein the ratio of the level of galactosylation of the antibody N-glycans in the population to the level of fucosylation of the antibody N-glycans in the population is between 0.8 and 1.2 (see pg. 13, lines 2-5). Comparatively, Faid et al. define a population of antibodies that are low galactose and/or low fucose refers to a population of antibodies wherein the level of galactosylation and/or fucosylation of the antibodies in the population is less than 50% (see pgs. 14-15).
Faid et al. teach of the population of antibodies are CD20 antibody constructs wherein the amino acid sequence for the CD20 antibody comprises SEQ ID NO:1 for the light chain and SEQ ID NO: 2 of the heavy chain (see Example 1). SEQ ID NOs: 1 and 2 disclosed by Faid et al. share 100% identity with SEQ ID NOs: 8-10 and 3-5, respectively, of the present invention (see alignment below). Faid et al. demonstrate that these CD20 antibody constructs had higher IL-2 cytokine release, induced cytotoxic activity, and had higher CDC activity than Rituxan (see pg. 57). Faid et al. teach that these CD20 antibody constructs demonstrated 100% functionality in the CDC and ADCC assays compared to 59% and 6% of Rituxan (see Fig. 8).
Faid et al. SEQ ID NOs: 1 and 2 alignments
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However, Faid et al. fail to teach of a single batch preparation of the population of anti-CD20 antibodies wherein the N-glycan profile is 10 to 20% galactosylated glycans and 20 to 40% fucosylated glycans as recited in instant claims 19 and 28. Also, Faid et al. fail to teach of bisecting N-glycans as recited in the present claims. Thus, the prior art does not teach or suggest the commercial scale preparation of populations of anti-CD20 antibody proteins comprising the specific range of glycans required by instant claims 19 and 28.
Conclusion
Claims 19-24, 28-29, 31-34, 46-48, 50-51, 53-55, and 57-58 are allowed.
Claims 27, 37, 49, and 56 are rejected.
Claims 30 and 52 are objected to.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674