Detailed Action
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 .
Claims 7-11, 17, 21, 24-26, 28-31, and 33 are cancelled.
Claims 1-5, 12-14, 16, 18-19, 23, and 17 are currently amended.
Claims 1-6, 12-16, 18-20, 22-23, 27, and 32 are pending and under examination on the merits.
Priority
This Application is a 371 of PCT/US2021/033150, filed 05/19/2021, which claims benefit of priority to U.S. Provisional Application Serial Nos. 63/026,826, filed on May 19, 2020, and 63/108,741, filed November 2, 2020.
Information Disclosure Statement
The IDS submissions dated 12/19/2025 have been considered. Certain references indicated by use of strikethrough were not considered because there is no portion provided which has been translated into English.
Claim Interpretation
In the interest of advancing prosecution, all recitations of “…units of …activity per gram…” are being interpreted as reciting ‘…units of…per gram…’.
Withdrawn Objections/Rejections
The objection to claim 1 is withdrawn in light of the clarifying amendments made in the 12/19/2025 claim amendments. The objection to claim 6 is withdrawn in light of the altered scope resulting from the 12/19/2025 claim amendments. The objection to claim 9 is withdrawn in light of the corrective 12/19/2025 claim amendments. The rejections of claims 2-5 and 18-19 under 35 USC §112(a) for lack of written description are withdrawn in light of the corrective 12/19/2025 claim amendments. The rejections of claims 4-5 and 13-16 under 35 USC §112(b) are withdrawn in light of the corrective 12/19/2025 claim amendments. The rejections of claims 8 and 11 under 35 USC 112(b) are withdrawn in light of the 12/19/2025 claim amendments cancelling the claims. The rejections of claims 12-14, 16, and 18-20 under 35 USC §112(b) are withdrawn in light of the persuasive arguments presented in the 12/19/2025 remarks (see pages 8/18-9/18 of said remarks; see also MPEP §2173.05(b)(III)(A)). The rejections under 35 USC §103 are withdrawn in light of the 12/19/2025 claim amendment which add novel and non-obvious matter to the instant claim scope which is not reasonably made obvious by the prior art. The rejections for double patenting are withdrawn in light of the 12/19/2025 claim amendment which alter the claim scope.
Newly Necessitated Claim Rejections - 35 USC § 112
35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 12-16, 18-20, 22-23, 27, and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claims 1-6, 12-16, 18-20, 22-23, 27, and 32 are drawn to methods for preparing/producing hsIgG comprising use of reagents where the concentration is recited as “…units of…activity per gram of pooled IgG…”. The specification does not disclose or contemplate the method(s) where any reagent is provided at a unit of activity. The term or any reasonably understood variant thereof is absent from the entirety of the disclosure.
Therefore, reciting any reagent at a concentration/amount of ‘units of…activity per gram…” is new matter that reaches beyond the specification as originally filed because the specification never contemplated the particular subgenus encompassed by the claim language.
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 1-6, 12-16, 18-20, 22-23, 27, and 32 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 1 recites the addition of at least about 6 ‘units of B4GalT activity’ and at least about 14 ‘units of ST6GAL activity’. A ‘unit of activity’ is not a recognized unit in the art. This idiosyncratic language is not employed or defined anywhere in the instant specification. This undefined terminology fails to clearly convey, without ambiguity, the amount of B4GalT and ST6Gal comprised by the claimed reaction mixture such that artisans are left to guess at and dispute alternative understandings of the amount of each reagent encompassed by the instantly claimed method. A recitation of “units” would be understood, but the recitation of “ units of…activity” raises the question of whether, for example, at least about 6 units of B4GalT would meet the claim or whether some other, unspecified limitation is intended to be claimed (and would therefore infringe the instant claim). The scope is clearly ambiguous because the metes and bounds of the claim are indefinite as drafted (see MPEP §2173.05(a) and 2111.01(IV)).
Claim 2 recites the addition of at least about 6 ‘units of B4GalT activity’ and at least about 14 ‘units of ST6GAL activity’. Units of activity is not a recognized unit in the art. This idiosyncratic language is not employed or defined anywhere in the instant specification. This undefined terminology fails to clearly convey, without ambiguity, the amount of B4GalT and ST6Gal comprised by the claimed reaction mixture such that artisans are left to guess at and dispute alternative understandings of the amount of each reagent encompassed by the instantly claimed method. A recitation of “units” would be understood, but the recitation of “ units of…activity” raises the question of whether, for example, at least about 6 units of B4GalT would meet the claim or whether some other, unspecified limitation is intended to be claimed (and would therefore infringe the instant claim). The scope is clearly ambiguous because the metes and bounds of the claim are indefinite as drafted (see MPEP §2173.05(a) and 2111.01(IV)).
Claim 3 recites the addition of at least about 6 ‘units of B4GalT activity’ and at least about 14 ‘units of ST6GAL activity’. Units of activity is not a recognized unit in the art. This idiosyncratic language is not employed or defined anywhere in the instant specification. This undefined terminology fails to clearly convey, without ambiguity, the amount of B4GalT and ST6Gal comprised by the claimed reaction mixture such that artisans are left to guess at and dispute alternative understandings of the amount of each reagent encompassed by the instantly claimed method. A recitation of “units” would be understood, but the recitation of “ units of…activity” raises the question of whether, for example, at least about 6 units of B4GalT would meet the claim or whether some other, unspecified limitation is intended to be claimed (and would therefore infringe the instant claim). The scope is clearly ambiguous because the metes and bounds of the claim are indefinite as drafted (see MPEP §2173.05(a) and 2111.01(IV)).
Claim 18 recites the addition of at least about 7.2 ‘units of B4GalT activity’. Units of activity is not a recognized unit in the art. This idiosyncratic language is not employed or defined anywhere in the instant specification. This undefined terminology fails to clearly convey, without ambiguity, the amount of B4GalT comprised by the claimed reaction mixture such that artisans are left to guess at and dispute alternative understandings of the amount of the reagent encompassed by the instantly claimed method. A recitation of “units” would be understood, but the recitation of “ units of…activity” raises the question of whether, for example, at least about 7.2 units of B4GalT would meet the claim or whether some other, unspecified limitation is intended to be claimed (and would therefore infringe the instant claim). The scope is clearly ambiguous because the metes and bounds of the claim are indefinite as drafted (see MPEP §2173.05(a) and 2111.01(IV)).
Claim 19 recites the addition of at least about 17.1 ‘units of ST6GAL activity’. Units of activity is not a recognized unit in the art. This idiosyncratic language is not employed or defined anywhere in the instant specification. This undefined terminology fails to clearly convey, without ambiguity, the amount of ST6Gal comprised by the claimed reaction mixture such that artisans are left to guess at and dispute alternative understandings of the amount of the reagent encompassed by the instantly claimed method. A recitation of “units” would be understood, but the recitation of “ units of…activity” raises the question of whether, for example, at least about 17.1 units of ST6Gal would meet the claim or whether some other, unspecified limitation is intended to be claimed (and would therefore infringe the instant claim). The scope is clearly ambiguous because the metes and bounds of the claim are indefinite as drafted (see MPEP §2173.05(a) and 2111.01(IV)).
Claims 4-6, 12-16, 20, 22-23, 27, and 32 are included in this rejection because, via dependency, they incorporate and fail to remedy the above noted deficiencies.
Conclusion
No claim is allowed.
As indicated in the office action dated 09/24/2025, SEQ ID NO: 13 has been searched and appears to be free from the prior art. The Examiner is interpreting the claims to encompass the only stated embodiment of adding 21 grams of pooled antibody to the reaction mixture(s) (see for example the Table on page 30). When applied to the claimed concentrations, that would equate to use of 0.798-0.966 mmol UDP-Gal and 2.9925-3.3075 mmol CMP-NANA (as recited in, for example, claims 13-14 and paragraph 1 of page 25) and 151.2-184.8U of B4GalT and 359.1-396.9U ST6Gal, where ‘U’ is a nmol (see the Enzymes section of page 13 of the instant specification). It is noted that a method for sialylation where total incubation is less than 72 hours and/or where the total amount of UDP-Gal, CMP-NANA, B4GalT and ST6Gal (as recited in instant claims 1-3, 13-14, 16 and 18-19) are not reasonably taught or made obvious by the prior art for predictable sialylation of IgG using BIS-TRIS buffer. The closest prior art is the combination of Washburn et al (Correction for Washburn et al., Controlled tetra-Fc sialylation of IVIg results in a drug candidate with consistent enhanced anti-inflammatory activity. Proc Natl Acad Sci US A. 2015 Aug 4;112(31):E4339. doi: 10.1073/pnas.1512309112. Epub 2015 Jul 13. Erratum for: Proc Natl Acad Sci US A. 2015 Mar 17;112(11):E1297-306. doi: 10.1073/pnas.1422481112; as cited on the 06/14/2024 IDS) in view of Hopax (The families of bio, logical buffers, obtained from: https://www.hopaxfc.com/en/blog/the-families-of-biological-buffers (01/22/2019); as cited in the previous office action dated 12/19/2025) as discussed in the rejections of the claims under 35 USC §103 as presented in the previous office action dated 09/24/2025. The combined prior art refences do not reasonably teach or suggest instant SEQ ID NO: 13, the claimed concentrations of UDP-GAL or CMP-NANA in mmol and the claimed concentrations of B4GalT and ST6Gal (where the recited ‘units of…activity’ are being interpreted for this purpose/analysis as reciting ‘units’), or a total incubation time of less than 72 hours. A further search of the prior art fails to reveal prior art which would reasonably lead the artisan to any of these limitations. There being no reasonable rationale for rejection, the claims are deemed to contain allowable subject matter.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Vattepu et al (Front Immunol. 2022 Apr 7;13:818736. doi: 10.3389/fimmu.2022.818736) teaches that different immunoglobulin classes differ in the number and/or distribution of galactosylation sites (glactosylation being the first step for producing sialylated antibody).
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examiner should be directed to ASHLEY GAO whose telephone number is (571) 272-5695. The
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supervisor, Gregory Emch can be reached on (571) 272-8149. The fax phone number for the
organization where this application or proceeding is assigned is 571-273-8300.
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/Ashley Gao/
Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678