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 .
CONTINUING DATA
This application is a 371 of PCT/JP2022/041129 11/04/2022
FOREIGN APPLICATIONS
JAPAN 2022-017564 02/07/2022
Claims 1-16 are pending.
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.
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 5-16 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.
Claims 5-16 are drawn to a drug delivery system formulation comprising a ligand derived from a compound of Formula (I’) or Formula (I). The claims are indefinite because it is unclear what is required by “drug delivery system formulation.” It is unclear whether the compound itself reads on the claims, or whether something additional is required to form a “drug delivery system formulation,” and what that additional thing might be. The specification does not provide any guidance on this point. It is also unclear what is encompassed by a ligand “derived” from the claimed compound. “Derived” from the compound implies that the compound is changed in some way, but the claims and specification do not clarify how the compound “derived” from formula (I) can differ from formula (I) itself.
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) 1-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamaji (Bioorg. Med. Chem. 72 (2022) 116972, available August 2022).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Yamaji teaches the following compounds on pages 2-3:
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Compound 5 is a compound of Formula (I). R2 is Formula (III) when X3 is O and R7 is the last moiety listed. In R7, s is 2 and R10 and R11 are each hydrogen. R3 is H. X1 is O. R4 is O. X2 is chemical formula 3 where n is 2. R5 and R6 are H and a hydroxy protecting group.
Compound GCL is a compound of claims 3-4 where R5 and R6 are H and a phosphate group protected by a protecting group. See also Scheme 1 for the structure of GCL.
The compound is used as a therapeutic against skeletal muscle diseases. See abstract.
Yamaji also teaches compound DTC on page 2:
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This is a compound of Formula (I’) where R2 is H, R3 is H, X1 is O, and R4 is O, and R1’ is a pentose moiety that includes a 2’-deoxyribos-1-yl structure. The nucleic acid monomer included 2’,4’-BNA/LNA monomer (See Section 5.3). One compound DTC was linked to the 5’ terminus of the polynucleic acid ASO (see Table 2 and abstract).
AIA 35 U.S.C. 102(b)(1)(A) first provides that a disclosure which would otherwise qualify as prior art under AIA 35 U.S.C. 102(a)(1) is excepted as prior art if the disclosure is made: (1) one year or less before the effective filing date of the claimed invention; and (2) by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor (i.e., an inventor-originated disclosure). If, however, the application names fewer joint inventors than a publication (e.g., the application names as joint inventors A and B, and the publication names as authors A, B and C), it would not be readily apparent from the publication that it is an inventor-originated disclosure and the publication would be treated as prior art under AIA 35 U.S.C. 102(a)(1) unless there is evidence of record that an exception under AIA 35 U.S.C. 102(b)(1) applies. See MPEP 2153.01(a). In this instance, the application names fewer joint inventors than the Yamaji publication.
Claim(s) 1-7, 10, 12-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamaji (Partial Translation of the 140th Annual Meeting of the Pharmaceutical Society of Japan (Kyoto), March 25th-28th, 2020, cited on IDS).
Yamaji teaches the following compounds:
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Compound G-clamp (1) is a compound of Formula (I’). R1 is a 2’deoxy-ribos-1-yl structure. R2 is Formula (III) when X3 is O and R7 is the second to last moiety listed. In R7, s is 2 and R10 and R11 are each hydrogen. R3 is H, X1 is O, and R4 is O, and R1’ is a pentose moiety that includes a 2’-deoxyribos-1-yl structure.
Compound 6 is a compound of Formula (I). R2 is Formula (III) when X3 is O and R7 is the last moiety listed. In R7, s is 2 and R10 and R11 are each hydrogen. R3 is H. X1 is O. R4 is O. X2 is chemical formula 3 where n is 2. R5 and R6 are H and a hydroxy protecting group.
The compound is used for incorporating into DNA. Page 2.
Claim(s) 6-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kishimoto (Chem. Eur. J. 2021, 27, 2427-2438, published 2020, cited on IDS).
Kishimoto teaches the following compounds in Figure 2:
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Compounds b-e are compounds of Formula (I’) where R2 is H or R2 is Formula (III) when X3 is O and R7 is the last moiety listed. In R7, s is 2 and R10 and R11 are each hydrogen. R3 is H. X1 is O. R4 is O. R1’ is a ribos-1-yl or 2’-deoxyribos-1-yl structure. The ligand is linked to the 5’ terminus of the polynucleic acid which can be a 2’,4’-BNA/LNA. Table 1 illustrates the ODNs used and shows that 1-3 ligands are linked. These ODNs can be considered aptamers. The compounds are used in therapeutics. See abstract.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
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