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 .
Status of Application, Amendments and/or Claims
Claims 1-29 are pending.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 15-22 and 28, drawn to an antibody conjugate, in the reply filed on 16 March 2026 is acknowledged.
Claims 1-14, 23-27, and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 16 March 2026.
Claims 15-22 and 28 are under consideration in the instant application.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 22 June 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
1. Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because primer sequences appear at page 55, [0219] of the specification, which are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
2. Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Specification
3. The disclosure is objected to because of the following informalities:
3a. The Brief Description of the Drawings does not refer to Figures 2A-2T.
Appropriate correction is required.
Claim Objections
4. Claim 15 is objected to because of the following informalities:
4a. Claim 15 recites the acronym “Man” without first defining what it represents (see for instance, subparts (i-iii, vii-x)). While the claims can reference acronyms, the material presented by the acronym must be clearly set forth at the first use of the acronym and/or in each independent claim.
4b. In claim 15, subparts (i-iii) and (vii-x) are not labeled in consecutive order. Subparts (iv), (v), and (vi) are missing. Therefore, subparts (vii-x) should be relabeled as subparts (iv), (v), (vi), and (vii), respectively.
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.
5. Claims 15-22 and 28 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.
5a. Claims 15-22 are rejected as being indefinite because 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 15 recites the broad recitation “wherein (G)e is connected to GlcNAc(Fuc)b via the bond labelled with ** and to Su via one of the bonds labelled *”, and the claim also recites specific * bond connections in subparts (i), (ii), (iii), and (vii-x) which is the narrower statement of the range/limitation (for example, “(G)e is connected to Su via (3)”). In the structure G1 in claim 15, there are five single starred bonds (and not just at locations 1 and 3 as recited in the subparts). Therefore, 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.
5b. Claim 16 is rejected as being indefinite because the claim recites elements on a structure (G2) without specifically reciting what they are or how they relate back to the structure in claim 15 (see, “β-1,4”; “α-1,6”; “α-1,3”; “β-1,2”; and “α-1,2”). Are these intended to be bonds or something else? It is not clear how the structure recited in claim 16 is any different from the structure of claim 15.
5c. Claim 28 is incomplete because it depends from withdrawn claim 14 (see MPEP §608.01(n)(V). Furthermore, claim 14 is a method claim and not a product claim. Therefore, the metes and bounds of claim 28 cannot be determined. Please note that this issue could be overcome by amending claim 28 to depend from claim 15.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
6. Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 16 recites:
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In view of the rejection of claim 16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, claim 16 does not recite any specific limitations that further limit the claimed antibody conjugate of claim 15. Therefore, claim 16 is of improper dependent form because it fails to further limit the subject matter of claim 15.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
7. Claims 15-22 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Delft et al. (US 2016/0235861 or WO 2015/057065 (cited on the IDS of 22 June 2023)). As both specifications are the same, for brevity, the teachings below will refer to WO 2015/057065.
Van Delft et al. state that the invention relates to modified antibodies, antibody-conjugates, and antibody-drug conjugates (page 1, lines 4-9; page 23). In particular, see the antibody conjugates in Figures 1-3 (in Figure 1, “G1F”, “G0F”; Figure 2, #3; Figure 3, all reproduced below). The Figures of Van Delft et al. disclose an antibody structure comprising a GlcNAc moiety (black square) with a fucose moiety (triangle), wherein b is 0 or 1, meeting the limitations of instant claims 15 and 18. The Figures of Van Delft et al. also teach the oligosaccharide structures recited in instant claim 15 (subparts viii, x) that comprise three mannoses at positions 1-3 and GlcNAc at positions 4 and 7 (Figure 1, “G0F”, Figure 2, #3). Figure 1 of Van Delft et al. discloses Gal at position 6, meeting the limitation of instant claim 15 (subparts vii and ix) ( “G1F”). Van Delft et al. state that one, two, or more N-linked GlcNAc residues may be obtained at glycosylation sites on the antibody, meeting the limitations of instant claims 15 and 17 (page 23, lines 20-33; page 24, lines 1-33; page 26, lines 23-31).
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Figure 3
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Additionally, Van Delft et al. teach attaching a monosaccharide derivative Su(A)x to a proximal N-linked GlcNAc residue, wherein x is 1, 2, 3, or 4, meeting the limitations of instant claim 15 (page 8, lines 22-31). Van Delft et al. indicate that Su(A)x is derived from a sugar or sugar derivative, such as galactose, mannose, glucose, N-acetylneuraminic acid, N-acetylglucosamine, and N-acetylgalactosamine, meeting the limitations of instant claims 19 and 20 (page 44, lines 7-29). Van Delft et al. disclose further reacting the N-linked GlcNAc-Su(A)x substituent with a linker-conjugate that comprises a functional B group and a molecule of interest (page 9, lines 1-21; page 58, lines 26-30). Van Delft et al. indicate when A (in Su(A)x ) is a thiol group, linking of the thiol-modified antibody with the linker conjugate takes place via a Michael-type addition reaction, meeting the limitations of instant claim 21 (page 59, lines 19-20). Van Delft et al. teach that the antibody-conjugate may be conjugated to one or more than one molecule of interest D via said linker L, meeting the limitations of instant claim 15 (page 23, lines 16-18; page 57, lines 1-2). Lastly, Van Delft et al. disclose that the antibody-conjugate is an active substance for use as a medicament (page 83, lines 13-26) and that the antibody-conjugate may be prepared in a buffer solution, such as saline, meeting the limitations of instant claim 28 (page 40, lines 1-5).
Conclusion
No claims are allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Boune et al. Antibodies 9, 22, doi:10.3390/antibod9020022, June 2020 (review of glycosylation on monoclonal antibody structure and function; review glycoengineering)
Buettner et al. Front Immunol 9: 2485, 2018 (review of glycosylation optimization and glycoengineering strategies)
Niwa et al. J Pharm Sci 104: 930-941, 2015 (review of glycol-engineered antibodies and antibody-drug conjugates)
Van Geel et al. Bioconjugate Chem 26: 2233-2242, 2015 (teach chemoenzymatic conjunction of drug payloads to the conserved N-glycan on native antibodies to provide antibody-drug conjugates; Figure 1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIDGET E BUNNER whose telephone number is (571)272-0881. The examiner can normally be reached Monday-Friday 9:00 am-6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BEB
Art Unit 1647
16 April 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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