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 .
DETAILED ACTION
Priority
The present application claims the benefit of U.S. Provisional Application No. 63/179,065, filed on April 23, 2021, U.S. Provisional Application No. 63/188,930 filed on May 14, 2021, and U.S. Provisional Application No. 63/189,492, filed on May 17, 2021, that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 08/03/2023 is acknowledged. Claims 30-34 and 36-40 are pending and under examination.
Election/Restrictions
Applicant’s election of species in the reply filed on 07/28/2026 is acknowledged.
Applicant elects the following species: Claims 31-34: SEQ ID NO: 2; Claims 36 or 37: alkyne (first click-chemistry) and azide (second click-chemistry); Claim 38: asparagine linked glycan comprising a bi-antennary glycan.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/30/2023 and 04/11/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) are being considered by the Examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application
specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and
(b)), and MPEP § 609.04(a), subsection I. states, "the list must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Drawings
The drawing filed on 08/03/2023 and replacement sheet (Fig. 15B) on 11/21/2023 are acknowledged and accepted by the Examiner.
Claim Objections
Claim 30 is objected to for the following informalities:
Claim 30 recites “L comprises a linker formed by a biorthogonal click chemistry reaction between the first click-chemistry handles the second click-chemistry handle”. The limitation should recite “between the first click-chemistry handles and the second click-chemistry handle”.
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.
Claims 36 and 37 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 36 and 37 are rejected for containing a reference to tables. MPEP 2173.05(s) states “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. Generally, the presence or absence of such reference characters does not affect the scope of a claim. See MPEP § 608.01(m) for information pertaining to the treatment of reference characters in a claim'.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine
grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or
improper timewise extension of the "right to exclude" granted by a patent and to prevent
possible harassment by multiple assignees. A nonstatutory double patenting rejection is
appropriate where the conflicting claims are not identical, but at least one examined
application claim is not patentably distinct from the reference claim(s) because the examined
application claim is either anticipated by, or would have been obvious over, the reference
claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman,
11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Langi, 759 F.2d 887, 225 USPQ 645 (Fed.
Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d
438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be
used to overcome an actual or provisional rejection based on nonstatutory double patenting
provided the reference application or patent either is shown to be commonly owned with the
examined application, or claims an invention made as a result of activities undertaken within
the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159.
See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to
file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR
1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory
double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be
accompanied by a reply requesting reconsideration of the prior Office action. Even where the
NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For
a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37
CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be
filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used.
Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in
which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or
PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely
on line using web-screens. An eTerminal Disclaimer that meets all requirements is autoprocessed
and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 30-34 and 36-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-8, 18-21, 24-27 and 30 of U.S. Patent No. 11766481. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another.
The claims are directed to a glyconucleic acid compound of Formula (I):
A-L-B (I),
or a salt, co-crystal, tautomer, stereoisomer, solvate, hydrate, polymorph, or an isotopically enriched derivative thereof, wherein:
A is a nucleic acid of deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) comprising a first click-chemistry handle;
B is an asparagine-linked glycan (N-glycan) comprising a second click-chemistry handle; and
L comprises a linker formed by a biorthogonal click chemistry reaction between the first click-chemistry handle the second click-chemistry handle.
The patented claims are directed to:
1. A pharmaceutical composition comprising:
a) a glyconucleic acid or salt thereof, the glyconucleic acid comprising:
i) a short interfering RNA (siRNA); and
ii) at least one oligosaccharide moiety comprising at least 6 monosaccharides, covalently bound to the siRNA; and
b) a pharmaceutically acceptable carrier;
wherein the at least one oligosaccharide moiety comprises a multiple antennary complex type N-glycan comprising at least one GlcNAc residue attached to the Manal-3 arm and at least one GlcNAc attached to the Manal-6 arm of a trimannose core (instant claims 30-34).
4. The pharmaceutical composition of claim 1, wherein at least one terminal residue of the multiple antennary complex type N-glycan comprises a monosaccharide selected from sialic acid, fucose, GlcNAc, mannose, and galactose (instant claims 38 and 39).
5. The pharmaceutical composition of claim 1, wherein the at least one oligosaccharide moiety is covalently bound to the siRNA via a click-chemistry reaction (instant claims 36 and 37).
6. The pharmaceutical composition of claim 1, wherein the siRNA is covalently bound to the oligosaccharide moiety via a linker group covalently bound to a terminus of the-siRNA (instant claim 30).
7. The pharmaceutical composition of claim 1, wherein the siRNA is covalently bound to the oligosaccharide moiety via a linker covalently bound to a chemically modified nucleotide in the middle of the siRNA (instant claim 30).
8. The pharmaceutical composition of claim 1, wherein the siRNA is covalently bound to the oligosaccharide moiety via a chemical handle inserted between two nucleotides of the siRNA (instant claim 30).
18. The pharmaceutical composition of claim 1, wherein the at least one oligosaccharide moiety comprises a bi-antennary complex type N-glycan comprising a first terminal residue and a second terminal residue (instant claim 38).
19. The pharmaceutical composition of claim 18, wherein at least one of the first terminal residue and the second terminal residue comprises a monosaccharide selected from sialic acid, GlcNAc and galactose (instant claim 40).
20. The pharmaceutical composition of claim 18, wherein at least one of the first terminal residue and the second terminal residue comprises sialic acid (instant claim 40).
21. The pharmaceutical composition of claim 18, wherein at least one of the first terminal residue and the second terminal residue comprises GlcNAc (instant claim 30).
24. The pharmaceutical composition of claim 1, wherein the at least one oligosaccharide moiety comprises a tri-antennary complex type N-glycan comprising a first terminal residue, a second terminal residue, and a third terminal residue (instant claim 39).
25. The pharmaceutical composition of claim 24, wherein at least one of the first terminal residue and the second terminal residue comprises a monosaccharide selected from sialic acid, GlcNAc, and galactose (instant claim 40).
26. The pharmaceutical composition of claim 24, wherein at least one of the first terminal residue, the second terminal residue, and the third terminal residue comprises sialic acid (instant claim 40).
27. The pharmaceutical composition of claim 24, wherein at least one of the first terminal residue, the second terminal residue, and the third terminal residue comprises GlcNAc (instant claim 39).
30. The pharmaceutical composition of claim 1, wherein the at least one oligosaccharide moiety comprises a glycan selected from G-1 (GlcNAc(b1-2)Man(a1-3)[GlcNAc(b1-2)Man(a1-6)]Man(b1-4)GlcNAc(b1-4)[Fuc(a1-6)]GlcNAc(b1-), G-2 (Neu5Ac(a2-6)Gal(b1-4)GlcNAc(b1-2)Man(a1-3)[Neu5Ac(a2-6)Gal(b1-4)GlcNAc(b1-2)Man(a1-6)]Man(b1-4)GlcNAc(b1-4)[Fuc(a1-6)]GlcNAc(b1-), G-4 (Gal(b1-4)GlcNAc(b1-2)Man(a1-3)[Gal(b1-4)GlcNAc(b1-2)Man(a1-6)][GlcNAc(b1-4)]Man(b1-4)GlcNAc(b1-4)GlcNAc(b1), G-5 (NeuNAc(a2-3)Gal(b1-4)GlcNAc(b1-2)Man(a1-3)[NeuNAc(a2-3)Gal(b1-4)GlcNAc(b1-2)Man(a1-6)]Man(b1-4)GlcNAc(b1-4)GlcNAc(b1-), G-8 (GlcNAc(b1-2)Man(a1-3)[GlcNAc(b1-2)Man(a1-6)]Man(b1-4)GlcNAc(b1-4)GlcNAc(b1-), G-9 (Gal(b1-4)GlcNAc(b1-2)Man(a1-3)[Gal(b1-4)GlcNAc(b1-2)Man(a1-6)]Man(b1-4)GlcNAc(b1-4)GlcNAc(b1-), G-10 (Neu5Ac(a2-6)Gal(b1-4)GlcNAc(b1-2)Man(a1-3)[Neu5Ac(a2-6)Gal(b1-4)GlcNAc(b1-2)Man(a1-6)]Man(b1-4)GlcNAc(b1-4)GlcNAc(b1-), G-11 (Gal(b1-4)GlcNAc(b1-2)Man(a1-3)[Gal(b1-4)GlcNAc(b 1-2)Man(a 1-6)]Man(b1-4)GlcNAc(b1-4)[Fuc(a1-6)]GlcNAc(b1-), and G-34 (Neu5Ac(a2-3)Gal(b1-4)GlcNAc(b1-2)Man(a1-3)[Neu5Ac(a2-3)Gal(b1-4)GlcNAc(b1-2)Man(a1-6)]Man(b1-4)GlcNAc(b1-4)GlcNAc(b1-) (instant claim 30).
There is no patentable difference between the claimed composition and the patented composition in that the U.S. Patent No. 11766481 (‘481) discloses glyconucleic acid compound of Formula (I): A-L-B (I), or a salt, co-crystal, tautomer, stereoisomer, solvate, hydrate, polymorph, or an isotopically enriched derivative thereof, wherein: A is a nucleic acid of deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) comprising a first click-chemistry handle; B is an asparagine-linked glycan (N-glycan) comprising a second click-chemistry handle; and L comprises a linker formed by a biorthogonal click chemistry reaction between the first click-chemistry handle the second click-chemistry handle. The composition of ‘481 would anticipate the compositions herein. Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
Prosecution Insights