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 Claims and Response to Amendments
The amendments filed January 15, 2026 have been acknowledged and entered. Claims 142-145, 147-158, 165, 167-172 and 180-184 are pending.
Information Disclosure Statements
Acknowledgement is made of the Information Disclosure Statement filed on January 15, 2026. All references have been considered except where marked with a strikethrough.
Election/Restriction
The present examination is based Applicant’s election without traverse of Group I (presently 142-145, 147-158, 165, 167-172 and 180-184) and the species corresponding to Compound I-7 in the reply filed on September 4, 2025. Applicant amendments have overcome the art rejection set forth in the previous Office Action.
The search has been expanded to include the full scope of the claims.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant’s amendments and/or
remarks.
Claim Objections
Claims 142-145, 147-158, 165, 167-172 and 180-184 objected to because of the following informalities:
Claim 142 has been amended to recite “W is…
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”. Examiner believes this may be a typo and Applicant instead intends CONH2 for the reason that the specification discloses numerous instances of wherein W is CONH2 (see e.g. [00113]); however the specification does not appear to disclose wherein W is
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.
Claims 143-145, 147-158, 165, 167-172 and 180-184 depend from claim 142 and include this limitation.
Appropriate clarification is required.
Maintained Rejections
Double Patenting
Claims 142-145, 147-158, 165, 167-172 and 180-184 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 5, 7, 18, 21-24, 29-31, 39-41, 45, 48, 50, 53-55, 57, 61-63, 65, 68, and 73 of copending Application No. 18/578,293(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the reference claims.
Claims 142-145, 147-158, 165, 167-172 and 180-184 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-15 of U.S. Patent No. 12,258,332. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the patent claims.
The reasons for these rejections were set forth in the previous Office Action mailed October 15, 2025 and are incorporated herein by reference.
Response to Arguments
Applicant' s arguments filed January 15, 2026 have been fully considered but they are not persuasive.
Applicant requests the rejections be held in abeyance until the claims are otherwise found allowable (page labeled 18 of remarks). This response is found not persuasive since a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Thus, the previous double patenting rejections are maintained.
Rejections Necessitated by Applicant Amendment
Claim Rejections - 35 USC § 112b
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.
Claim 165 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.
Claim 165 recites W is CH2, N, O or S. There is insufficient antecedent basis for these limitations because claim 165 depends from claim 142 which requires that
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Claim Rejections - 35 USC § 102
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) 142-143, 149-153, 156-157, 167-168, 171-172, 180-181 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garcia (US8,962,573 B2) (hereinafter “Garcia”).
Garcia teaches a conjugate, wherein said conjugate is a product of interest Y wherein Y is a glycoprotein conjugated via a linker L with a compound having formula (I) (see claim 1). Garcia teaches the compound having formula (I) is a carboxylate (see Fig 7C; col 20 Fig 7 shows improvement in binding affinity of carboxylate; compound of carboxylate pictured below for convenience). Garcia teaches Y is conjugated via the linker with at least 1 to 10 compounds having formula (1) (claim 3)
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Figure 7C
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The conjugate disclosed by Garcia corresponds to the sodium salt of a cell surface mannose-6-phosphate receptor (M6PR) binding compound of instant Formula (XI) wherein W is -CO2Na (which is the sodium salt of CO2H); Z1 is –(CH2)j- wherein j is 2; Z2 is O; Ar is phenyl; Z3 is -NR23CO- wherein R23 is H; n is 1 to 6; L is a linker corresponding to
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; and Y is an antibody (Ab). As evidenced by Houen et al. (Advances in Clinical Chemistry Vol 81, 2017, 43-96), glycoproteins include antibodies (see Introduction, “Antibodies are antigen-binding multimeric glycoproteins secreted by plasma cells”).
Garcia teaches each and every limitation of the claimed compound and therefore anticipates the claimed invention.
Claim(s) 142-143, 149-153, 156-157, 168, 171-172 and 181 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kinzel et al (Journal of Peptide Science 2003, 9, 375-385 ) (hereinafter “Kinzel”).
Kinzel teaches conjugate 13 which is produced by combination of target cluster mannoside 2 with peptide 10 (see Figure 2; Figure 4; Scheme 3, 13 (conjugate 2 + 10); page 380 Conjugate 13, to a solution of 10… was added mannoside 2; mannoside 2 and peptide 10 pictured below).
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Conjugate 13 of Kinzel corresponds a cell surface mannose-6-phosphate receptor (M6PR) binding compound of instant Formula (XI) wherein W is -OH; Z1 is –(CH2)j- wherein j is 1; Z2 is O; Ar is phenyl; Z3 is -NR23C(=X1)NR23 wherein R23 is H and X1 is S; n is 6; L is a linker; and Y is an antibody fragment corresponding to
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. The specification and claims do not provide any structural definition or limitation to what is regarded as an antibody fragment. The amino acid sequence of Kinzel is therefore regarded as meeting the claim limitations of an antibody fragment.
Conclusion
No claim is allowed.
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 KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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February 19, 2026
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624