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 .
Election/Restrictions
Applicant's election with traverse of species A1 (HCl), species B2 (first and second oligosaccharides contain sialyl group), C1 (3’-SL), D (LST-a), and E2 (LNT) in the reply filed on 2/4/2026 is acknowledged. The traversal is on the ground(s) that the Examiner fails to articulate a grounds for requiring restriction. This is not found persuasive because the species are mutually exclusive.
The requirement is still deemed proper and is therefore made FINAL.
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species D, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/4/2026.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 2 is objected to because of the following informalities:
In regard to claim 2: the limitation “comprised in a neuraminic acid” is not grammatically correct.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-5, 7, 9, 11, 13, 18, 20-22, 24, 26, 28-29, 33, 35, 37-38 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.
The term “weakly basic” in claim 1 is a relative term which renders the claim indefinite. The term “weakly basic” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. All dependent claims are rejected as well since they do not rectify the indefinites of claim 1.
Claim 2 recites the limitation "the carboxylic acid group”. There is insufficient antecedent basis for this limitation in the claim. It is not clear if this refers to the carboxylic acid group on the first or second oligosaccharide or both.
In regard to claim 3, it is not clear if the chemical formula is required.
In regard to claim 13, the scope of the claim is unclear since it depends from a cancelled claim.
The term “strong” in claim 26 is a relative term which renders the claim indefinite. The term “strong” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The terms “weakly basic” and “weak basic” in claims 28-29, 33, and 38 is a relative term which renders the claim indefinite. The terms “weakly basic” and “weak basic” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 29 recites the limitation "the an aqueous solution”. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
The following is a statement of reasons for the indication of allowable subject matter: the combination of method steps including the pH ensuring 90% protonation of carboxylic acid groups, an aqueous solution, and a basic macroporous anion exchange resin in combination with a first and second oligosaccharide containing at least one carboxylic acid group is novel and not obvious over the closest prior art. The closest prior art of record includes references disclosed in the PCT search report, specifically WO03/080872, WO2019/003133, WO2013/085384; in addition to Analysis of Oligosaccharide Negative Charge by Anion-Exchange Chromatography by Varki (Varki).
Claims 1-5, 7, 9, 11, 13, 18, 20-22, 24, 26, 28-29, 33, 35, 37-38 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA M PEO whose telephone number is (571)272-9958. The examiner can normally be reached 9 to 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA M PEO/Primary Examiner, Art Unit 1777
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