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 .
The applicant's election of Group I, claims 1-9, without traverse in their reply dated 7/24/2026 is acknowledged. Claims 10-20 were cancelled. Claims 1-9 are pending and considered on the merits below.
Information Disclosure Statement
The Information Disclosure Statements filed on 10/4/2023 and 2/28/2024 are in compliance with the provisions of 37 CFR 1.97 and have been considered. An initialed copy of the Form 1449 is enclosed herewith.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (US 2019/0117790 A1).
Regarding claims 1 and 2, Song describes a reagent comprising a solution of a compound having two or more terminal azide functionalities and a terminus having a moiety capable of covalently bonding with an amine group and wherein the compound has three or more terminal azide functionalities and the terminus having a moiety capable of covalently bonding with an amine group
([0163]
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Regarding claim 3, Song describes the reagent according to claim 1, wherein the compound is present in the solution in a concentration up to about 10mM ([0351] “40 µL (200 µg) of PEG1 solution having a concentration of 100 mg/mL (prepared with I mM HC1) was quickly added to a coupling buffer system (50 mM sodium phosphate, pH 6.0, 50 mM sodium chloride, 1 mM EDTA), this is a concentration of up to about 10mM).
Regarding claim 4, Song describes the reagent of claim 1 further comprising a biologically compatible buffer solution ([0351] “The starting materials were fed in accordance with a molar ratio of antibody to [PEG-1] of 1:60. 40 µL (200 µg) of PEG1 solution having a concentration of 100 mg/mL (prepared with I mM HC1) was quickly added to a coupling buffer system (50 mM sodium phosphate, pH 6.0, 50 mM sodium chloride, I mM EDTA) containing 1.0 mg of antibody (42 µL of 24.5 mg/mL antibody was added to 118 µL of the coupling buffer).”).
Regarding claim 5, Song describes the reagent according to claim 4, wherein the compound is present in the solution in a concentration up to about 10mM ([0351] “40 µL (200 µg) of PEG1 solution having a concentration of 100 mg/mL (prepared with I mM HC1) was quickly added to a coupling buffer system (50 mM sodium phosphate, pH 6.0, 50 mM sodium chloride, 1 mM EDTA), this is a concentration of up to about 10mM).
Claim(s) 6-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Delft et al. (WO 2021/144313 Al).
Regarding claims 6, 8, and 9, Van Delft describes a reagent comprising a solution of a compound having the general formula (I):
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, wherein each X represents a polyethylene glycol, a is 1 and Y is nitrogen, wherein the compound of general formula (I) is N-(PEG3-N-hydroxysuccinimide)-N-bis(PEG3-azide).
(page 79
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Regarding claim 7, Van Delft describes the reagent according to claim 6, wherein at least one X comprises an additional branching point from which a bridging group having a terminal azide moiety is pendant (page 23 “The branching moiety BM [0109] A “branching moiety” in the context of the present invention refers to a moiety that is embedded in a linker connecting three moieties. In other words, the branching moiety comprises at least three bonds to other moieties, one bond to reactive group F, connecting group Z or payload 25 D, one bond to reactive group Q or connecting group Z, and one bond to reactive group Q or connecting group Z.” see also [0109-0117] and figure 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R BERKELEY whose telephone number is (571)272-9831. The examiner can normally be reached M-Th 9-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
/EMILY R. BERKELEY/
Examiner
Art Unit 1796
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