DETAILED ACTION
Claims 3-5, 7-9, 12, 16, 18, 22-23, 25-26 and 33-34 were/stand cancelled. Claims 1-2, 6, 10-11, 13-15, 17, 19-21, 24 and 27-32 are pending.
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 .
Priority
This application is a 371 of PCT/US2022/077767 (10/07/2022) which claims benefit of 63/253,917 (10/08/2021) as reflected in the filing receipt issued on April 23 2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 20 2024, August 1 2024, March 20 2025, July 22 2025 and January 9 2026 are 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
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claim 13 is objected to because of the following informalities: the acronym “S-cEt” is not defined in the claims. When an acronym is used in a claim set, it should be defined the first time it appears in the claims. For the purposes of examination, the term “S-cEt” is interpreted to mean S-constrained ethyl.. Appropriate correction is required.
Claims 11 and 15 are objected to because of the following informalities: the species are separated by commas; however, one species is 2,6-diaminopurine which necessarily contains a comma in the name. To prevent confusion the species should be separated by a semi-colon or the 2,6-diaminopurine should be the last species listed. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 6, 14-15 and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Landthaler et al. (USPGPUB No. 20110287412) as evidenced by Pivarcsi et al. (USPGPUB No. 20100202973).
The instant application claims a compound comprising a modified oligonucleotide, wherein the modified oligonucleotide has the following structure in the 5' to 3' orientation: (N)p(N")-(N’)q is from 7 to 24; q is 0 or 1; each N of (N)p, independently, comprises a modified sugar moiety or an unmodified sugar moiety, and the nucleobase sequence of (N)p is complementary to an equal-length portion of a microRNA, wherein (i) the nucleobase at position 1 of the microRNA is a uracil nucleobase and/or a cytosine nucleobase; (ii) the nucleobase at position 2 of the microRNA is a uracil nucleobase and/or a cytosine nucleobase; or (iii) the nucleobase at position 1 of the microRNA is a uracil and/or a cytosine nucleobase and the nucleobase at position 2 of the microRNA is a uracil nucleobase and/or a cytosine nucleobase; N" is a nucleoside comprising a modified sugar moiety or an unmodified sugar moiety, and the nucleobase of N" is opposite position 2 of the microRNA; wherein if q is 1, N' is a nucleoside comprising a modified sugar moiety or an unmodified sugar moiety, and the nucleobase of N' is opposite position 1 of the microRNA, wherein if q is 0, the nucleobase of N" is a uracil nucleobase, a cytosine nucleobase, or a purine nucleobase, provided that the purine nucleobase does not have a hydrogen bond acceptor at position 6, wherein if q is 1, at least one nucleobase of N' and N" is a uracil nucleobase, a cytosine nucleobase, or a purine nucleobase, provided that the purine nucleobase does not have a hydrogen bond acceptor at position 6; or a pharmaceutically acceptable salt thereof.
The examiner interprets position 1 as being the first nucleobase at the 5’ position of the miRNA and position 2 as the second nucleobase at the 5’ position of the miRNA. The recitation “is opposite position 2” is interpreted as requiring the N” nucleotide to correspond position 2 of the microRNA which would require that (N)p complementary starts at position 3 of the microRNA. The recitation is opposite does not require the nucleobase to be complementary to the microRNA.
Landthaler et al. is directed to methods for identifying RNA segments bound by RNA-binding proteins or ribonucleoprotein complexes. Exemplified sequences include 2’-O-methyl oligoribonucleotides and miRNA duplexes. Specifically including anti-miR-20a and anti-miR-106b.
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98
576
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101
576
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Regarding the claimed oligonucleotide, the above sequences have an q of 1, wherein N’ is A (adenosine which purine nucleobase that does not have a hydrogen bond acceptor at position 6), N” is U (uracil). The rest of the nucleotide is 21 nucleobases long (anti-miR-20a) or 19 nt long (anti-miR-106b) and are complementary to an equal-length portion of a microRNA (as shown below) reading on (N)p
As evidenced by Pivarcsi et al., miR-20a has the following sequence:
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25
344
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and miR-106b has the following sequence:
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28
342
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(table 2).
This results in the anti-miR-20a of having 100% complementary identity to miR-20a:
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508
772
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506
681
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And anti-miR-106b having 100% complementary identity to miR-106b:
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517
775
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Greyscale
Regarding claim 2, 14-15, as set forth above the microRNA have uracil nucleobase at position 1, q is 1 and N’ is A (adenosine, purine base that does not have a hydrogen bond acceptor).
Regarding claim 6, as set forth above the oligonucleotide has q is 1 and N’ is A (purine nucleobase that does not have a hydrogen bond. While the miR-106b and miR-20a do not have a cytosine at position 1, this limitation is directed to the microRNA not the claimed oligonucleotide. Since nothing in the claim actually requires complementary to the miRNA at this position, the sequence set forth in Landthaler et al. reads on the claim.
Regarding claim 20, p is 21 or 19.
Regarding claim 21, the nucleobase is 100% complementary to the nucleobase sequence of the microRNA.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 6, 10-11, 13-15, 17, 19-21, 24 and 28-32 are rejected under 35 U.S.C. 103 as being unpatentable over Ivanovska et al. (USPGPUB No. 20090136957) in view of Elmen et al. (USPGPUB No. 20100286234) and Kamiya et al. (ChemBioChem, 2017, cited on PTO Form 1449).
Applicant Claims
The instant application claims a compound comprising a modified oligonucleotide, wherein the modified oligonucleotide has the following structure in the 5' to 3' orientation: (N)p(N")-(N’)q is from 7 to 24; q is 0 or 1; each N of (N)p, independently, comprises a modified sugar moiety or an unmodified sugar moiety, and the nucleobase sequence of (N)p is complementary to an equal-length portion of a microRNA, wherein (i) the nucleobase at position 1 of the microRNA is a uracil nucleobase and/or a cytosine nucleobase; (ii) the nucleobase at position 2 of the microRNA is a uracil nucleobase and/or a cytosine nucleobase; or (iii) the nucleobase at position 1 of the microRNA is a uracil and/or a cytosine nucleobase and the nucleobase at position 2 of the microRNA is a uracil nucleobase and/or a cytosine nucleobase; N" is a nucleoside comprising a modified sugar moiety or an unmodified sugar moiety, and the nucleobase of N" is opposite position 2 of the microRNA; wherein if q is 1, N' is a nucleoside comprising a modified sugar moiety or an unmodified sugar moiety, and the nucleobase of N' is opposite position 1 of the microRNA, wherein if q is 0, the nucleobase of N" is a uracil nucleobase, a cytosine nucleobase, or a purine nucleobase, provided that the purine nucleobase does not have a hydrogen bond acceptor at position 6, wherein if q is 1, at least one nucleobase of N' and N" is a uracil nucleobase, a cytosine nucleobase, or a purine nucleobase, provided that the purine nucleobase does not have a hydrogen bond acceptor at position 6; or a pharmaceutically acceptable salt thereof.
The instant application claims the N” and N’ is a purine nucleobase that does not have a hydrogen bond acceptor at position 6 such as 2,6-diaminopurine.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Ivanovska et al. is directed to methods and compositions for regulating cell cycle progression via the miR-106B family. Claimed is a method of inhibiting proliferation of a cell comprising introducing an effective amount of a miR specific inhibitor of at least one miR-106b family member into the cell (claim 1). The cell can be a mammalian cell or a cancer cell (claims 2-3). Members of the miR-106b family include miR-106b (SEQ ID NO: 1), miR-106a (SEQ ID NO: 2), miR-20a (SEQ ID NO: 3), miR-20b (SEQ ID NO: 4) and miR-17-5p (SEQ ID NO: 5) (claim 4; paragraph 0009). The miR-specific inhibitor comprises a polynucleic acid molecule comprising a nucleotide sequence of at least six contiguous nucleotides that is complementary to positions 2-8 of the miR-106b seed region (“AAAGUGC” SEQ ID NO:8) (paragraph 0011). A miR-specific inhibitor may be an anti-miRNA oligonucleotide which may comprise RNA or DNA or have non-nucleotide components. The anti-miR may comprise a nucleotide sequence that is a perfect complement of the entire miRNA while in other embodiments a nucleotide sequence has at least 6 consecutive nucleotides that complementary. Chemical modifications include 2’-O-methoxyethyl and phosphorothioate (paragraph 0055). Anti-miR sequences are shown (paragraph 0067). Nucleobase refers to a heterocyclic base, such as for example a naturally occurring nucleobase (i.e., an A, T, G, C or U) found in at least one naturally occurring nucleic acid (i.e., DNA and RNA), and naturally or non-naturally occurring derivative(s) and analogs of such a nucleobase (paragraph 0108). “Purine” and/or “pyrimidine” nucleobase(s) encompass naturally occurring purine and/or pyrimidine nucleobases and also derivative(s) and analog(s) thereof, including but not limited to, those a purine or pyrimidine substituted by one or more of an alkyl, carboxyalkyl, amino, hydroxyl, halogen (i.e., fluoro, chloro, bromo, or iodo), thiol or alkylthiol moiety. Preferred alkyl (e.g., alkyl, carboxyalkyl, etc.) moieties comprise of from about 1, about 2, about 3, about 4, about 5, to about 6 carbon atoms. Other non-limiting examples of a purine or pyrimidine include a deazapurine, a 2,6-diaminopurine, a 5-fluorouracil, a xanthine, a hypoxanthine, a 8-bromoguanine, a 8-chloroguanine, a bromothymine, a 8-aminoguanine, a 8-hydroxyguanine, a 8-methylguanine, a 8-thioguanine, an azaguanine, a 2-aminopurine, a 5-ethylcytosine, a 5-methylcyosine, a 5-bromouracil, a 5-ethyluracil, a 5-iodouracil, a 5-chlorouracil, a 5-propyluracil, a thiouracil, a 2-methyladenine, a methylthioadenine, a N,N-dimethyladenine, an azaadenines, a 8-bromoadenine, a 8-hydroxyadenine, a 6-hydroxyaminopurine, a 6-thiopurine, a 4-(6-aminohexyl/cytosine), and the like (paragraph 0109). A nucleic acid may comprise, or be composed entirely of, a derivative or analog of a nucleobase, a nucleobase linker moiety and/or backbone moiety that may be present in a naturally occurring nucleic acid (paragraph 0113).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Ivanovska et al. suggests purines such as 2,6-diaminopurines, Ivanovska et al. does not expressly teach the use of this purine. However, this deficiency is cured by Elmen et al. and Kamiya et al.
Elmen et al. is directed to pharmaceutical compositions comprising anti-miRNA antisense oligonucleotides. Taught are the use of short oligonucleotides designed to bind with high affinity to miRNA targets are highly effective in alleviating the repression of mRNA by microRNAs in vivo (paragraph 0020). Taught are oligonucleotides having a length between 8 and 18 nucleobase units (paragraph 0022). In some embodiments, the oligonucleotide does not comprise a nucleobase at the 3’ end that corresponds to the first 5’ end nucleotide of the target microRNA (paragraph 0121). The first nucleobase and/or second nucleobase counting from the 3’ end is a nucleotide analogue (paragraph 0122-0123). In one embodiment, all the internucleoside linkages are phosphorothioate linkages (paragraph 0199). The term "nitrogenous base" is intended to cover purines and pyrimidines, such as the DNA nucleobases A, C, T and G, the RNA nucleobases A, C, U and G, as well as non-DNA/RNA nucleobases, such as 5-methylcytosine (MeC), isocytosine, pseudoisocytosine, 5-bromouracil, 5-propynyluracil, 5-propyny-6-fluoroluracil, 5-methylthiazoleuracil, 6-aminopurine, 2-aminopurine, inosine, 2,6-diaminopurine, 7-propyne-7-deazaadenine, 7-propyne-7-deazaguanine and 2-chloro-6-aminopurine, in particular MeC. It will be understood that the actual selection of the non-DNA/RNA nucleobase will depend on the corresponding (or matching) nucleotide present in the microRNA strand which the oligonucleotide is intended to target (paragraph 0211).
Kamiya et al. is directed to the introduction of 2,6-diaminopurines into serinol nucleic acid improves anti-miRNA performance. Taught are anti-miRNA oligonucleotides (AMOs) which are inhibitors of miRNA activity. Chemical modification of AMOs is required to increase binding affinity and stability in serum and cells. The addition of 2,6-diaminopurine (D) residues results in significant improvement (page 1917, first paragraph). To increase duplex stability, 2,6-diaminopurine which forms three hydrogen bonds with uracil rather than the two formed with adenine was introduced in place of adenine (page 1918, left column). Taught is replacing all adenines with 2,6-diaminopurine. The antisense activity was significantly increased relative to sequences without the (D) residues. While the number of D residues was positively correlated with the number of D substitutions, the anti-miRNA activity did not correlate (page 1919-1920, bridging paragraph). Introduction of D at positions complementary to both the 5’ and 3’ end regions of the miRNA improved antisense activity (page 1921, last paragraph).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of Ivanovska et al., Elmen et al. and Kamiya et al. and form an anti-miR oligonucleotide which has at least six contiguous nucleotides that is complementary to positions 2-8 of the miR-106b seed region (“AAAGUGC”). One skilled in the art would have been motivated to form this oligonucleotide as Ivanovska et al. teaches anti-miR which have this region complementary to any of the specifically taught miR-106 family. Various anti-miR taught specifically by Ivanovska et al. end UA or UU or UC reading on instantly claimed N’ and N”.
Regarding claims 2 and 6, Ivanovska et al. teaches anti-miR which have a U, C or A. The miR are taught as being of sequence 1-5. Seq ID NO: 1/3 has a U as position 1, SEQ ID NO: 4/5 has a C at position 1.
Regarding claims 10-11 and 14-15, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of Ivanovska et al., Elmen et al. and Kamiya et al. and utilize 2,6-diaminopurine in the oligonucleotide sequence. One skilled in the art would have been motivated to utilize 2,6-diaminopurine as Ivanovska et al. suggests that these alternative purines can be utilized. One skilled in the art would have been motivated to utilize 2,6-diaminopurine as this nucleobase is taught as improving antisense activity by Kamiya et al. One skilled in the art would have been motivated to utilize the alternative nucleobase at position 1 and 2 as taught by Elmen et al. Furthermore, one skilled in the art would have been motivated to manipulate the type and frequency of modifications in order to achieve the optimal level of antisense activity in combination with stability as taught by Elmen et al. and Kamiya et al.
Regarding claims 17, 19, Ivanovska et al. teaches 2’-O-methoxyethyl and phosphorothioate modifications. Kamiya et al. teaches that chemical modification of AMOs is required to increase binding affinity and stability in serum and cells. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of Ivanovska et al., Elmen et al. and Kamiya et al. and utilize the amount of type of chemical modification in order to achieve the desired binding affinity and stability. The prior art clearly teaches the importance of chemical modification of oligonucleotide sequences and suggests various different modifications which can be utilized. Absent demonstration of the criticality, one skilled in the art would manipulate not only the number but the type and location in order to achieve the desired stability and binding affinity.
Regarding claim 20, anti-miR taught by Ivanovska et al. contain p lengths of 19 and 21.
Regarding claim 21, Ivanovska et al. teaches anti-miR are complementary to the seed region and at least 50% up to at al least 90% complementary to the rest of the miRNA (paragraph 0055).
Regarding claims 24 and 28, Ivanovska et al. teaches compositions for storage or administration which includes a pharmaceutically effective amount of the desired compounds in a pharmaceutically acceptable carrier or diluent (paragraph 0196). Elman et al. teaches carriers can be saline or buffered saline (paragraph 0374).
Regarding claims 29-32, Ivanovska et al. claims introducing an effective amount of a miR specific inhibitor into the cell wherein the cell can be a mammalian cell or a cancer cell (claims 1-3). Elman et al. teaches treating diseases or disorders associated with the presence or increase expression of a miR comprising administering to a person in need thereof an oligonucleotide (claims 134 and claim 155). Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of Ivanovska et al., Elmen et al. and Kamiya et al. and administer the anti-miR oligonucleotides to a cell, wherein the cell can be in a person in need thereof in order to reduce expression of the miR as suggested by Ivanovska et al. and Elmen et al.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Ivanovska et al. in view of Elmen et al. and Kamiya et al. as applied to claims 1-2, 6, 10-11, 13-15, 17, 19-21, 24 and 28-32 above and in further view of Bennett et al. (USPGPUB No. 20100267814).
Applicant Claims
The instant application claims a pharmaceutical composition comprising a compound as claimed above which is a lyophilized composition.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teachings of Ivanovska et al., Elmen et al. and Kamiya et al. are set forth above.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Ivanovska et al. teaches a carrier or diluent, Ivanovska et al. does not expressly teach a lyophilized composition. However, this deficiency is cured by Bennett et al.
Bennett et al. is directed to targeting microRNAs for the treatment of liver cancer. Dosage unit means a form in which a pharmaceutical agent is provided. A dosage unit is vial containing lyophilized oligonucleotide. In certain embodiments, a dosage unit is a vial containing reconstituted oligonucleotide (paragraph 0085). A pharmaceutical agent is a sterile lyophilized modified oligonucleotide that is reconstituted with a suitable diluent, e.g. sterile water for injection or sterile saline for injection (paragraph 0322).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Ivanovska et al., Elmen et al., Kamiya et al. and Bennett et al. and utilize a vial containing a lyophilized oligonucleotide. One skilled in the art would have been motivated to utilize a vial containing a lyophilized oligonucleotide in order to store and ship the oligonucleotide as Ivanovska et al. teaches compositions for storage of the oligonucleotides and Bennett et al. teaches vials with lyophilized oligonucleotide. Since Bennett et al. suggests the lyophilized oligonucleotide can be reconstituted with saline there is a reasonable expectation of success.
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 Longi, 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 online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 6, 13-14, 17, 19-21, 24 and 27-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12559750 as evidenced by Pivarcsi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims a compound comprising a modified oligonucleotide, wherein the modified oligonucleotide has the following structure in the 5' to 3' orientation: (N)p(N")-(N’)q is from 7 to 24; q is 0 or 1; each N of (N)p, independently, comprises a modified sugar moiety or an unmodified sugar moiety, and the nucleobase sequence of (N)p is complementary to an equal-length portion of a microRNA, wherein (i) the nucleobase at position 1 of the microRNA is a uracil nucleobase and/or a cytosine nucleobase; (ii) the nucleobase at position 2 of the microRNA is a uracil nucleobase and/or a cytosine nucleobase; or (iii) the nucleobase at position 1 of the microRNA is a uracil and/or a cytosine nucleobase and the nucleobase at position 2 of the microRNA is a uracil nucleobase and/or a cytosine nucleobase; N" is a nucleoside comprising a modified sugar moiety or an unmodified sugar moiety, and the nucleobase of N" is opposite position 2 of the microRNA; wherein if q is 1, N' is a nucleoside comprising a modified sugar moiety or an unmodified sugar moiety, and the nucleobase of N' is opposite position 1 of the microRNA, wherein if q is 0, the nucleobase of N" is a uracil nucleobase, a cytosine nucleobase, or a purine nucleobase, provided that the purine nucleobase does not have a hydrogen bond acceptor at position 6, wherein if q is 1, at least one nucleobase of N' and N" is a uracil nucleobase, a cytosine nucleobase, or a purine nucleobase, provided that the purine nucleobase does not have a hydrogen bond acceptor at position 6; or a pharmaceutically acceptable salt thereof.
Patent ‘750 claims a modified oligonucleotide having the structure:
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which corresponds to AGCACUUUA and contains phosphorothioate and constrained ethyl modifications. Pharmaceutical composition comprising the oligonucleotide with a pharmaceutically acceptable diluent is claimed (claim 109). Saline solution is claimed (claim 111). Lyophilized composition is claimed (claim 118).
As evidenced by Pivarcsi et al., miR-20a has the following sequence:
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and miR-106b has the following sequence:
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(table 2).
The sequence claimed in Patent ‘750 has 100% complementary identity to mirR-20a
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And 100% complementary identity to miR-106b
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. Therefore, the AGCACUUA sequence reads on instant claim 1 wherein p is 7, N” is opposite position 2 of a microRNA, N’ is opposite position 1 and is a purine nucleobase that does not have a hydrogen bond acceptor (i.e. is A).
Regarding claim 2, either miR-106b or miR-20a have U at position 1.
Regarding claim 6, nothing in the claim actually requires the microRNA to be present or that the oligonucleotide is complementary to position 1 of the microRNA. Thus claim 6 is anticipated as it does not affect the oligonucleotide sequence claimed.
Regarding claim 13, N” of Patent ‘750 is a S-cEt sugar.
Regarding claim 14-15, N’ is an A aka adenosine.
Regarding claim 17, N’ is an S-cET sugar.
Regarding claim 19, the linkages are taught as phosphorothioate.
Regarding claim 20, p is 7.
Regarding claim 21, the modified oligonucleotide is 100% complementary.
Regarding claims 24 and 27-28, Patent ‘750 claims the same.
Claims 1-2, 6, 13-15, 17, 19-21, 24 and 27-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, 12-14, 16, 21-22, 24, 27-30, 32-36, 38, 59, 60, 68, 72, 74, 78, 85, 87-88, 90 and 100 of copending Application No. 18610891 (USPGPUB No. 20240294913). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection.
The instant claims are set forth above.
Copending ‘891 claims a compound comprising a modified oligonucleotide, wherein the modified oligonucleotide has the following structure in the 5' to 3' orientation: (N")p-(N),-(N’)q wherein each N" is, independently, a modified or unmodified nucleoside; p is from 0 to 14; wherein if p is not 0, the nucleobase sequence of (N")p is complementary to an equal-length portion of the nucleobase sequence of miR-17; each N of (N)r is, independently, a modified or unmodified nucleotide, and the nucleobase sequence of (N), is 5'-AGCACUUU-3'; N' is a nucleoside comprising a modified sugar moiety; q is 0 or 1; wherein if q is 1, the nucleobase of N' is a uracil nucleobase, a cytosine nucleobase, or a purine nucleobase, provided that the purine nucleobase does not have a hydrogen bond acceptor at position 6; and each cytosine is independently selected from a non-methylated cytosine and a 5-methylcytosine; or a pharmaceutically acceptable salt thereof. Each internucleoside linkage is a phosphorothioate. As claimed p is from 1-14. N’ can be an adenosine, 2-aminopurine, 2,6-diaminpurine and isoguanosine. 2’-O-methoxyethyl sugar or an S-cEt sugar are claimed. Compositions with a diluent is claimed. Saline solution is claimed. Lyophilized composition is claimed. A method for inhibiting the activity of one or members of the miR-17 family in a cell is claimed. Administering to a subject the compound for inhibiting the activity of one or more members of the miR-17 family is claimed. Treating polycystic kidney disease claimed.
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as both claim overlapping sequences.
Claims 1-2, 6, 13-15, 17, 19-21, 24 and 28-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 19473981 (published also as WO2024215846) as evidenced by Pivarcsi et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection.
The instant claims are set forth above.
Copending ‘981 claims a method of treating polycystic kidney disease comprising administering to a subject in need thereof a modified oligonucleotide or a pharmaceutically acceptable salt thereof at a dose of 0.5 - 5 mg/kg, 0.5 - 4.5 mg/kg, 0.5 - 4 mg/kg, 0.5 - 3.5 mg/kg, 0.5 - 3 mg/kg, 1 - 5 mg/kg, 1 - 4.5 mg/kg, 1 - 4 mg/kg, 1 - 3.5 mg/kg, or 1 - 3 mg/kg, wherein the modified oligonucleotide has the structure 5'-AsGsCMAFCFUFUMUsAs-3', wherein nucleosides followed by subscript "M" are 2'-O-methyl nucleosides; nucleosides followed by subscript "F" are 2'-fluoro nucleosides; and nucleosides followed by subscript "S" are S-cEt nucleosides, and wherein each cytosine is a non-methylated cytosine. A composition comprising a pharmaceutically acceptable diluent is claimed. A saline solution is claimed.
As evidenced by Pivarcsi et al., miR-20a has the following sequence:
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and miR-106b has the following sequence:
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(table 2).
The sequence claimed in copending ‘981 has 100% complementary identity to mirR-20a
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And 100% complementary identity to miR-106b
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. Therefore, the AGCACUUA sequence reads on instant claim 1 wherein p is 7, N” is opposite position 2 of a microRNA, N’ is opposite position 1 and is a purine nucleobase that does not have a hydrogen bond acceptor (i.e. is A).
Regarding claim 2, either miR-106b or miR-20a have U at position 1.
Regarding claim 6, nothing in the claim actually requires the microRNA to be present or that the oligonucleotide is complementary to position 1 of the microRNA. Thus claim 6 is anticipated as it does not affect the oligonucleotide sequence claimed.
Regarding claim 13, N” of copending ‘981 is a S-cEt sugar.
Regarding claim 14-15, N’ is an A aka adenosine.
Regarding claim 17, N’ is an S-cET sugar.
Regarding claim 19, the linkages are taught as phosphorothioate.
Regarding claim 20, p is 7.
Regarding claim 21, the modified oligonucleotide is 100% complementary.
Regarding claims 24 and 28, copending ‘981 claims the same.
Regarding claims 29-32, the claims merely require contacting a cell or administering to a subject the compound or composition. This is claimed by copending ‘981.
Claims 29-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12559750 as evidenced by Pivarcsi et al. as applied to claims 1-2, 6, 13-14, 17, 19-21, 24 and 27-28 above in view of Ivanovska et al. and Elman et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims a method for inhibiting the activity of a microRNA in a cell, comprising contacting the cell with a compound as set forth above.
The instant application claims a method for inhibiting the activity of a microRNA in a human subject, comprising administering to the subject a pharmaceutical composition as set forth above.
The teachings of Patent ‘750 are set forth above. While Patent ‘750 teaches pharmaceutical compositions with an oligonucleotide which is complementary to an microRNA (as evidenced by Pivarcsi et al. ), Patent ‘750 does not claim a method. However, this deficiency is cured by Ivanovska et al. and Elman et al.
Regarding claims 29-32, Ivanovska et al. claims introducing an effective amount of a miR specific inhibitor into the cell wherein the cell can be a mammalian cell or a cancer cell (claims 1-3). Elman et al. teaches treating diseases or disorders associated with the presence or increase expression of a miR comprising administering to a person in need thereof an oligonucleotide (claims 134 and claim 155). Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of Patent ‘750, Ivanovska et al. and Elmen et al. and administer the oligonucleotides of Patent ‘750 to a cell, wherein the cell can be in a person in need thereof in order to reduce expression of the miR as suggested by Ivanovska et al. and Elmen et al. There is a reasonable expectation of success as Ivanovska et al. teaches the same miR as the oligonucleotides of Patent ‘750 are shown as being complementary to vis Pivarcsi et al.
Claim 27 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 19473981 (published also as WO2024215846) as evidenced by Pivarcsi et al. as applied to claims 1-2, 6, 13-15, 17, 19-21, 24 and 28-32 above in view of Bennett et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims the composition is lyophilized.
The claims of copending ‘981 are set forth above.
While copending ‘981 claims a composition, copending ‘981 does not claim a lyophilized composition. However, this deficiency is cured by However, this deficiency is cured by Bennett et al.
Bennett et al. is directed to targeting microRNAs for the treatment of liver cancer. Dosage unit means a form in which a pharmaceutical agent is provided. A dosage unit is vial containing lyophilized oligonucleotide. In certain embodiments, a dosage unit is a vial containing reconstituted oligonucleotide (paragraph 0085). A pharmaceutical agent is a sterile lyophilized modified oligonucleotide that is reconstituted with a suitable diluent, e.g. sterile water for injection or sterile saline for injection (paragraph 0322).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘981 and Bennett et al. and utilize a vial containing a lyophilized oligonucleotide. One skilled in the art would have been motivated to utilize a vial containing a lyophilized oligonucleotide in order to store and ship the oligonucleotide as Bennett et al. teaches vials with lyophilized oligonucleotide as dosage forms. Since Bennett et al. suggests the lyophilized oligonucleotide can be reconstituted with saline there is a reasonable expectation of success.
Claims 1-2, 6, 13-15, 17, 19-21, 24, 27-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12005120. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘120 claims a method of inhibiting the activity of miR-122 in a cell comprising contacting a cell with a compound. Claimed is a method of treating HCV invention comprising administering to an HCV-infected subject at lest one dose of a compound. A pharmaceutical composition comprising a compound and a diluent is claimed. A saline solution and lyophilized composition is claimed. The compound is:
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which corresponds to N’ being an adenosine and the sequence UCACACTCCA The compound includes phosphorothioates and constrained ethyl modifications. The compound corresponds to a p of 8. The miR-122 has a sequence corresponding to SEQ ID NO: 1 (column 10, lines 52-54):
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. This corresponds to the claimed compound having 100% complementary identity to miR-122:
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Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as both claim overlapping sequences.
Claims 1-2, 6, 13-15, 17, 20-21 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9994846. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘846 claims a method of inhibiting the proliferation of a liver cancer cell comprising contact the cell with a compound of formula I. The cell is either in vitro or in vivo. MO of formula I has the sequence ACATCAGTCTGAUAAGCUA and contains 2’-MOE or S-cET nucleosides. The sequence corresponds to N’ being A.
Patent ‘846 teaches these compound modulate MIR-21 (title) which has the following sequence:
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(column 15). This means the claimed sequence has 100% complementary identity to miR-21:
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Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as both claim overlapping sequences.
Regarding claim 29 merely requires administering the oligonucleotide to a cell which is claimed by Patent ‘846.
Claims 24, 27-28 and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9994846 as applied to claims 1-2, 6, 13-15, 17, 20-21 and 29 above in view of Bennett et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The claims of Patent ‘846 are set forth above.
While Patent ‘846 claims a method of administering, Patent ‘846 does not expressly claim a composition. However, this deficiency is cured by Bennett et al.
The teachings of Bennett et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘846 and Bennett et al. and utilize a vial containing a lyophilized oligonucleotide. One skilled in the art would have been motivated to utilize a vial containing a lyophilized oligonucleotide in order to store and ship the oligonucleotide as Bennett et al. teaches vials with lyophilized oligonucleotide as dosage forms. Since Bennett et al. suggests the lyophilized oligonucleotide can be reconstituted with saline suggesting saline solutions.
Claims 1-2, 6, 13-15, 17, 19-21 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 8969317. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘317 claims a compound comprising a modified oligonucleotide consisting of 15-19 linked nucleosides wherein the nucleobase sequence is complementary to miR-21 and include S-cET and 2’-OMOE modifications. Phosphorothioate linkages are claimed. The modified oligonucleotide has the following structure:
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. Compositions comprising the compound and a carrier is claimed.
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as both claim overlapping sequences.
Claims 1-2, 6, 13-15, 17, 19-21 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9267137. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘137 claims a compound comprising a modified oligonucleotide consisting of 12-15 linked nucleosides wherein the nucleobase sequence is complementary to miR-21 and include S-cET and 2’-OMOE modifications. Phosphorothioate linkages are claimed. The modified oligonucleotide has the following structure:
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. Compositions comprising the compound and a carrier is claimed.
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as both claim overlapping sequences.
Claims 1-2, 6, 13-15, 17, 19-21 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9688985. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘985 claims a compound comprising a modified oligonucleotide consisting of 19 linked nucleosides having the structure:
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wherein the nucleobase sequence is complementary to miR-21 (title) and include S-cET and 2’-OMOE modifications. Phosphorothioate linkages are claimed. Compositions comprising the compound and a carrier is claimed.
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as both claim overlapping sequences.
Claims 1-2, 6, 13-15, 17, 19-21, 24 and 29-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9970009. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘009 claims a compound comprising a modified oligonucleotide consisting of 11-19 linked nucleosides wherein the nucleobase sequence is complementary to miR-21 and include S-cET and 2’-OMOE modifications. Phosphorothioate linkages are claimed. The modified oligonucleotide has the following structure:
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. Compositions comprising the compound and a carrier is claimed. A method of inhibiting the activity of miR-21 by contacting a cell with a compound is claimed. Treating miR-21 associated diseases is claimed.
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as both claim overlapping sequences.
Claims 1-2, 6, 13-15, 17, 19-21, 24 and 29-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9157083 OR claims 1-15 of US Patent No. 9309513 OR claims 1-34 of US Patent No. 9574194 OR claims 1-20 of US Patent No. 10150967. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘083 claims a compound comprising a modified oligonucleotide of the following structure:
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which includes 2’-MOE or S-cEt and phosphorothioate. Pharmaceutical compositions are claimed.
Patent ‘513 claims a method of treating an HCV infection comprising administering a composition comprising a compound which has the sequence:
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.
Patent ‘194 claims a compound comprising 16 to 22 linked nucleosides which are complementary to miR-122. 2’-Omethoxyethyl and cEt nucleosides are claimed. The nucleobase sequence is selected from SEQ ID No: 3-6.
Patent ‘967 claim a method of treating an HCV infection comprising administering to an HCV-infected human a therapeutically effective amount of a pharmaceutical composition wherein the oligonucleotide has the sequence:
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which includes 2’-MOE, S-cEt and phosphorothioates.
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as both claim overlapping sequences as the sequence end in C and are complementary to miR-122.
Claims 1-2, 6, 13-15, 17, 19-21, 24 and 29-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. Patent No. 7683036 OR claims 1-22 of US Patent No. 8106025 OR claims 1-25 of US Patent No. 8110558 OR claims 1-21 of US Patent No. 8178506 OR claims 1-22 of US Patent No. 8546350 OR claims 1-28 of US Patent No. 8765701 or claims 1-22 of US Patent No. 8859521 or claims 1-20 of US Patent No. 9447413 or claims 1-21 of US Patent No. 9528108 or claims 1-20 of US Patent No. 10072265 or claims 1-20 of US Patent No. 10093926 or claims 1-19 of US Patent No. 10584336. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
All the patents claim inhibiting an miR such as miR-122 or miR-155. All of the inhibitors are oligonucleotides which include modification including 2’-O-methoxy-ethyl. Phosphorothioates are claimed. The oligonucleotides have an N’ which are A, C or U.
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as both claim overlapping sequences as the sequence end in C/U/A and are complementary to miR-122 or miR-155.
Conclusion
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/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636
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