DETAILED ACTION
The examiner for your application at the USPTO has changed. Examiner Abigail VanHorn can be reached at 571-270-3502.
Election/Restrictions
Applicant’s election without traverse of Group I, S-[N-(4-phenylbenzyl)carboxamide]-2’-deoxyuridine and protein in the reply filed on May 26 2026 is acknowledged. In light of the elected species, Groups II-III are rejoined as these groups include the elected species. Additionally, the species election has been expanded to include:
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as this R1 group was found to be coextensive with the elected biphenyl. Claims 9-10, 13, 15-16, 19-20, 23, 26, 33, 37, 40, 42, 44, 46, 49, 56, 61, 77 and 79 are pending in the application. The examiner notes that in the restriction requirement mailed on February 27 2026, claim 46 was inadvertently left out of a group. This claim should have been included in its own group, Group VIII, directed to a method of treating or preventing a disease or condition in a subject. This group lacks unity for the same reasons set forth in the restriction requirement mailed on February 27 2026. Claims 46, 49, 56, 61 and 79 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 May 26 2026. Accordingly, claims 9-10, 13, 15-16, 19-20, 23, 26, 33, 37, 40, 42, 44 and 77 are being examined on the merits herein.
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/US2022/024361 (04/12/2022) which claims benefit of 63/174,792 (04/14/2021) and claims benefit of 63/174,495 (04/13/2021) as reflected in the filing receipt issued on June 9 2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on October 5 2023, May 29 2026 and June 18 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to for the following reasons: 37 CFR 1.84 (u)(1) states “Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter.”
In the current case, the view numbers for the partial views for Figures 2, 3, 4, 5 and 6 that appear on several sheets are followed by "Cont." instead of a capital letter such as FIG. 2A, FIG. 2B, etc.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112-Indefinite
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 77 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.
Regarding claim 77, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The “such as” language occurs in lines 4, 5, 8 and 9 of the claim.
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 9-10, 13, 15-16, 19-20, 23, 26, 33, 37, 40, 42, 44 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Wolk et al. (Nucleic Acids Research, 2015) in view of Levy (WO2015066001).
Applicant Claims
The instant application comprises a compound of formula IA or IB wherein IB is elected:
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as elected the compound is S-[N-(4-phenylbenzyl)carboxamide]-2’-deoxyuridine which corresponds to L of CH2, R1 of
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and X of H, R2 of OH and R3 of OH. The species election has been expanded to include L of any length including 0, and R1 of
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.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Wolk et al. is directed to the influence of 5-N-carboxamide modifications on the thermodynamic stability of oligonucleotides. It is taught that recently it has been shown that incorporation of modified nucleotides such as 5-N-carboxamide-deoxyuridines into random nucleic acid libraries improves success rates in SELEX experiments and facilitates the identification of ligands with slow off-rates. Both benzyl and naphthyl modifications stabilized intramolecular single-stranded structures relative to their natural DNA analogs (abstract). SELEX is taught as being used in a method for discovery of nucleic acid-based affinity reagents called aptamers. These reagents bind to targets such as proteins (page 9107, left column). Recently developed SELEX protocols include the use of modified nucleotides. The strongest binding is usually observed with variants of these modified nucleotides that contain hydrophobic aromatic moieties such as benzyl, naphthyl and tryptamino. These functional groups allow interactions with protein hydrophobic surfaces that are not possible with standard DNA nucleotides as well as allowing stacking interactions that stabilize the aptamer structural framework (page 9107, right column). The 5-(N-carboxamide)-2’-deoxyuridine nucleotides that form the core of the studies were shown in Table 1.
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Shown in Table 2 are oligonucleotides which include either 8 modified positions or 6 modified positions. In both series variants include those with all positions substituted with the same modified nucleotides or one example of a mixed modification. Taught is samples were prepared in an appropriate buffer (page 9109, left column).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Wolk et al. teaches 5-(N-carboxamide)-2’-deoxyuridine nucleotides with hydrophobic modifications wherein the modified nucleotides can be used in aptamers for SELEX, Wolk et al. does not teach the hydrophobic moiety includes
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or
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. However, this deficiency is cured by Levy.
Levy is directed to nucleic acid scaffold small molecules libraries. Claimed is an oligonucleotide comprising a nucleotide residue comprising a modified nucleobase wherein the modified nucleobase is a pyrimidine modified at the 5 position thereof or a purine modified at the 7 position thereof (claim 1). Modifications of the 5 or 7 position expressly claimed include
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,
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(claim 2; Fig. 3) The nucleotide residue comprises a deoxyuridine (claim 4). One specific compound claimed is a 7 modified compound which includes
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(claim 5). It is taught that aptamers are generated by SELEX (paragraph 0004). Taught is contacting a protein target with a plurality of any of the oligonucleotides wherein at least two of the oligonucleotides have different sequences, washing to remove unbound oligonucleotides and recovering and sequencing oligonucleotides bound to the target protein (paragraph 0008). As claimed the oligonucleotide comprises more than one nucleotide residue comprising a modified nucleobase wherein the modified nucleobases are independently chosen (claim 7) where at least two different modified nucleobases is claimed (claim 8). Ligand is for a protein target (claim 11). Plurality of nucleotides is taught (paragraph 0055).
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 Wolk et al. and Levy and utilize hydrophobic modifications such as
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in the 5-(N-carboxamide)-2’-deoxyuridine of Wolk et al. Wolk et al. teaches hydrophobic modifications at the 5 position of deoxyuridine and teaches the benefits of benzyl groups for stacking interactions. Wolk et al. teaches modifications such as benzyl or naphthyl. Levy also teaches modifications at the 5 position of deoxyuridine and that these modifications include benzyl or naphthyl as well as biphenyl and phenoxybenzene. Levy teaches that the same modifications can occur at the 5 position or the 7 position and expressly teaches
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and
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at the 7 position. There is a reasonable expectation of success as both Wolk et al. and Levy teach the use of the modified nucleotides in aptamers which are used with SELEX.
Regarding the claimed structure, deoxyuridine results in X of H, R2 of OH and R3 of OH which reads on Formula IB and Formula IIB. As shown in the structure above, attachment of the biphenyl or the phenoxybenzene results in L of CH2 wherein n is 1. These structures read on PBn-U and POP-U of claim 20.
Regarding claims 23, 26, 37, 40 and 42, both Wolk et al. and Levy teach oligonucleotides (aptamers) which contain more than one modification and that the aptamer targets a protein (reading on instantly elected target). Wolk et al. teaches compositions and Levy teaches a plurality of aptamers.
Regarding claim 44, Wolk et al. teaches the oligonucleotide in a buffer reading on a pharmaceutically acceptable carrier.
Regarding claim 77, the BRI of the claim is a kit comprising the compound of claim 9. The additional language recited in claim 77 follows the word optionally which is interpreted as not requiring anything following the optionally recitation. Even if the optional language was not present, the claim only requires one of a-g, thus the buffer taught in Wolk et al. reaches on carrier or excipient.
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 9-10, 13, 15-16, 19-20, 23, 26, 33, 37, 40, 42, 44 and 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9163056 in view of Levy (WO2015066001). 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 comprises a compound of formula IA or IB wherein IB is elected:
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as elected the compound is S-[N-(4-phenylbenzyl)carboxamide]-2’-deoxyuridine which corresponds to L of CH2, R1 of
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and X of H, R2 of OH and R3 of OH. The species election has been expanded to include L of any length including 0, and R1 of
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.
Patent ‘056 claims a C-5 modified aminocarbonylpyrimidine having the following structure:
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wherein R’ can be H, R” can be H, X can be H, R is –(CH2)n-RX1 wherein n is 0-10 and RX1 is
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(claim 1).
While Patent ‘056 claims a phenyl modified uridine, Patent ‘056 does not claim
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or an oligonucleotide containing the modified uridine. However, this deficiency is cured by Levy.
Levy is directed to nucleic acid scaffold small molecules libraries. Claimed is an oligonucleotide comprising a nucleotide residue comprising a modified nucleobase wherein the modified nucleobase is a pyrimidine modified at the 5 position thereof or a purine modified at the 7 position thereof (claim 1). Modifications of the 5 or 7 position expressly claimed include
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(claim 2; Fig. 3) The nucleotide residue comprises a deoxyuridine (claim 4). One specific compound claimed is a 7 modified compound which includes
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(claim 5). It is taught that aptamers are generated by SELEX (paragraph 0004). Taught is contacting a protein target with a plurality of any of the oligonucleotides wherein at least two of the oligonucleotides have different sequences, washing to remove unbound oligonucleotides and recovering and sequencing oligonucleotides bound to the target protein (paragraph 0008). As claimed the oligonucleotide comprises more than one nucleotide residue comprising a modified nucleobase wherein the modified nucleobases are independently chosen (claim 7) where at least two different modified nucleobases is claimed (claim 8). Ligand is for a protein target (claim 11). Plurality of nucleotides is taught (paragraph 0055). Compositions are taught (abstract).
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 ‘056 and Levy and utilize hydrophobic modifications such as
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in place of the phenyl group claimed in patent ‘056. Levy teaches modifications at the 5 position of deoxyuridine and that these modifications include benzyl or naphthyl as well as biphenyl and phenoxybenzene. Levy teaches that the same modifications can occur at the 5 position or the 7 position and expressly teaches
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and
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at the 7 position. There is a reasonable expectation of success as both patent ‘056 and Levy teach the use of the modified nucleotides specifically C-5 modified uridine and Levy teaches that the modification can be a phenyl or biphenyl or phenoxybenzyl.
Regarding the claimed structure, deoxyuridine results in X of H, R2 of OH and R3 of OH which reads on Formula IB and Formula IIB. As shown in the structure above, attachment of the biphenyl or the phenoxybenzene results in L of CH2 wherein n is 1. These structures read on PBn-U and POP-U of claim 20.
Regarding claims 23, 26, 37, 40 and 42, Levy teach oligonucleotides (aptamers) which contain more than one modification and that the aptamer targets a protein (reading on instantly elected target). Levy teaches a plurality of aptamers and compositions. 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 ‘056 and Levy and utilize the modified pyrimidines in aptamers as these are a known use of the modified nucleotides as taught by Levy.
Regarding claim 44, Levy teaches compositions. 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 ‘056 and Levy and utilize a carrier to transport the oligonucleotide.
Regarding claim 77, the BRI of the claim is a kit comprising the compound of claim 9. The additional language recited in claim 77 follows the word optionally which is interpreted as not requiring anything following the optionally recitation.
Claims 9-10, 13, 15-16, 19-20, 23, 26, 33, 37, 40, 42, 44 and 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10221207 in view of Levy (WO2015066001). 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 are set forth above.
Patent ‘207 claims a C-5 modified aminocarbonylpyrimidine having the following structure:
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wherein R’ can be H, R” can be H, X can be H, R is –(CH2)n-RX1 wherein n is 0-10 and RX1 is
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(claim 1).
While Patent ‘207 claims a phenyl modified uridine, Patent ‘207 does not claim
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or
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or an oligonucleotide containing the modified uridine. However, this deficiency is cured by Levy.
The teachings of Levy 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 ‘207 and Levy and utilize hydrophobic modifications such as
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in place of the phenyl group claimed in patent ‘207. Levy teaches modifications at the 5 position of deoxyuridine and that these modifications include benzyl or naphthyl as well as biphenyl and phenoxybenzene. Levy teaches that the same modifications can occur at the 5 position or the 7 position and expressly teaches
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at the 7 position. There is a reasonable expectation of success as both patent ‘207 and Levy teach the use of the modified nucleotides specifically C-5 modified uridine and Levy teaches that the modification can be a phenyl or biphenyl or phenoxybenzyl.
Regarding the claimed structure, deoxyuridine results in X of H, R2 of OH and R3 of OH which reads on Formula IB and Formula IIB. As shown in the structure above, attachment of the biphenyl or the phenoxybenzene results in L of CH2 wherein n is 1. These structures read on PBn-U and POP-U of claim 20.
Regarding claims 23, 26, 37, 40 and 42, Levy teach oligonucleotides (aptamers) which contain more than one modification and that the aptamer targets a protein (reading on instantly elected target). Levy teaches a plurality of aptamers and compositions. 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 ‘207 and Levy and utilize the modified pyrimidines in aptamers as these are a known use of the modified nucleotides as taught by Levy.
Regarding claim 44, Levy teaches compositions. 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 ‘207 and Levy and utilize a carrier to transport the oligonucleotide.
Regarding claim 77, the BRI of the claim is a kit comprising the compound of claim 9. The additional language recited in claim 77 follows the word optionally which is interpreted as not requiring anything following the optionally recitation.
Claims 9-10, 13, 15-16, 19-20, 23, 26, 33, 37, 40, 42, 44 and 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10927380 in view of Wolk et al. (Nucleic acids, 2015) and (Levy (WO2015066001). 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 are set forth above.
Patent ’380 claim an aptamer comprising at least one first 5-position modified pyrimidine and at least one second 5-position modified pyrimidine wherein the 5-position modified pyrimidine can be a uridine and comprises a moiety at the 5-position of naphthyl, a benzyl moiety, etc. (claim 1). A composition comprising a plurality of polynucleotides with the modification is claimed (claim 8). A target being a protein is claimed (claim 15).
While Patent ‘380 claims a benzyl modified uridine, Patent ‘380 does not claim
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. However, this deficiency is cured by Wolk et al. Levy.
Wolk et al. is directed to the influence of 5-N-carboxamide modifications on the thermodynamic stability of oligonucleotides. It is taught that recently it has been shown that incorporation of modified nucleotides such as 5-N-carboxamide-deoxyuridines into random nucleic acid libraries improves success rates in SELEX experiments and facilitates the identification of ligands with slow off-rates. Both benzyl and naphthyl modifications stabilized intramolecular single-stranded structures relative to their natural DNA analogs (abstract). SELEX is taught as being used in a method for discovery of nucleic acid-based affinity reagents called aptamers. These reagents bind to targets such as proteins (page 9107, left column). Recently developed SELEX protocols include the use of modified nucleotides. The strongest binding is usually observed with variants of these modified nucleotides that contain hydrophobic aromatic moieties such as benzyl, naphthyl and tryptamino. These functional groups allow interactions with protein hydrophobic surfaces that are not possible with standard DNA nucleotides as well as allowing stacking interactions that stabilize the aptamer structural framework (page 9107, right column). The 5-(N-carboxamide)-2’-deoxyuridine nucleotides that form the core of the studies were shown in Table 1.
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Shown in Table 2 are oligonucleotides which include either 8 modified positions or 6 modified positions. In both series variants include those with all positions substituted with the same modified nucleotides or one example of a mixed modification. Taught is samples were prepared in an appropriate buffer (page 9109, left column).
The teachings of Levy 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 ‘380, Wolk et al. and Levy and utilize hydrophobic modifications such as
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as the “a benzyl” modification in patent ‘380. Wolk et al. teaches the use of an amide (C(O)NH) to attach various hydrophobic groups to uridine. Levy teaches modifications at the 5 position of deoxyuridine and that these modifications include benzyl or naphthyl as well as biphenyl and phenoxybenzene. Levy teaches that the same modifications can occur at the 5 position or the 7 position and expressly teaches
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at the 7 position. Thus, it would have been obvious to utilize these modifications as they are both “a benzyl” modification. There is a reasonable expectation of success as both patent ‘380 and Levy teach the use of the modified nucleotides specifically C-5 modified uridine and Levy teaches that the modification can be a phenyl or biphenyl or phenoxybenzyl.
Regarding the claimed structure, deoxyuridine results in X of H, R2 of OH and R3 of OH which reads on Formula IB and Formula IIB. As shown in the structure above, attachment of the biphenyl or the phenoxybenzene results in L of CH2 wherein n is 1. These structures read on PBn-U and POP-U of claim 20.
Regarding claims 23, 26, 37, 40 and 42, Patent ‘380 claims aptamers which contain more than one modification and that the aptamer targets a protein (reading on instantly elected target).
Regarding claim 44, Levy teaches compositions. 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 ‘380, Wolk et al. and Levy and utilize a carrier to transport the oligonucleotide.
Regarding claim 77, the BRI of the claim is a kit comprising the compound of claim 9. The additional language recited in claim 77 follows the word optionally which is interpreted as not requiring anything following the optionally recitation.
Claims 9-10, 13, 15-16, 19-20, 23, 26, 33, 37, 40, 42, 44 and 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11578330 in view of Wolk et al. (Nucleic acids, 2015) and (Levy (WO2015066001). 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 are set forth above.
Patent ’330 claims a method for identifying one or more aptamers comprising contacting a library of aptamers wherein the library of aptamers comprise a plurality of polynucleotides wherein each polynucleotide comprises at least one first 5-position modified pyrimidine and at least one second 5-position modified pyrimidine wherein the 5-position modified pyrimidine can be a uridine and comprises a moiety at the 5-position of naphthyl, a benzyl moiety, etc. (claim 1). As claimed the moiety of the 5-position modified uridine is covalently linked via a linker comprising an amide (claim 6). A composition comprising a plurality of polynucleotides with the modification is claimed (claim 8). A target being a protein is claimed (claim 21).
While Patent ‘330 claims a benzyl modified uridine, Patent ‘330 does not claim
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. However, this deficiency is cured by Wolk et al. Levy.
The teachings of Wolk et al. are set forth above.
The teachings of Levy 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 ‘330, Wolk et al. and Levy and utilize hydrophobic modifications such as
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as the “a benzyl” modification in patent ‘330. Wolk et al. teaches the use of an amide (C(O)NH) to attach various hydrophobic groups to uridine which coincide with the amide linker claimed by patent ‘330. Levy teaches modifications at the 5 position of deoxyuridine and that these modifications include benzyl or naphthyl as well as biphenyl and phenoxybenzene. Levy teaches that the same modifications can occur at the 5 position or the 7 position and expressly teaches
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at the 7 position. Thus, it would have been obvious to utilize these modifications as they are both “a benzyl” modification. There is a reasonable expectation of success as both patent ‘330 and Levy teach the use of the modified nucleotides specifically C-5 modified uridine and Levy teaches that the modification can be a phenyl or biphenyl or phenoxybenzyl.
Regarding the claimed structure, deoxyuridine results in X of H, R2 of OH and R3 of OH which reads on Formula IB and Formula IIB. As shown in the structure above, attachment of the biphenyl or the phenoxybenzene results in L of CH2 wherein n is 1. These structures read on PBn-U and POP-U of claim 20.
Regarding claims 23, 26, 37, 40 and 42, Patent ‘330 claims aptamers which contain more than one modification and that the aptamer targets a protein (reading on instantly elected target).
Regarding claim 44, Levy teaches compositions. 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 ‘330, Wolk et al. and Levy and utilize a carrier to transport the oligonucleotide.
Regarding claim 77, the BRI of the claim is a kit comprising the compound of claim 9. The additional language recited in claim 77 follows the word optionally which is interpreted as not requiring anything following the optionally recitation.
Claims 9-10, 13, 15-16, 19-20, 23, 26, 33, 37, 40, 42, 44 and 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12180482 in view of Wolk et al. (Nucleic acids, 2015) and (Levy (WO2015066001). 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 are set forth above.
Patent ’482 claim an aptamer comprising at least one first 5-position modified pyrimidine and at least one second 5-position modified pyrimidine wherein the 5-position modified pyrimidine can be a uridine and comprises a moiety at the 5-position of naphthyl, a phenyl moiety, etc. (claim 1). An amide linker is claimed (claim 2). A composition comprising a plurality of polynucleotides with the modification is claimed (claim 5). A target being a protein is claimed (claim 13).
While Patent ‘482 claims a phenyl modified uridine, Patent ‘482 does not claim
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. However, this deficiency is cured by Wolk et al. Levy.
The teachings of Wolk et al. are set forth above.
The teachings of Levy 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 ‘482, Wolk et al. and Levy and utilize hydrophobic modifications such as
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in place of the phenyl modification in patent ‘482. Wolk et al. teaches the use of an amide (C(O)NH) to attach various hydrophobic groups to uridine which coincide with the amide linker claimed by patent ‘482. Levy teaches modifications at the 5 position of deoxyuridine and that these modifications include benzyl or naphthyl as well as biphenyl and phenoxybenzene. Levy teaches that the same modifications can occur at the 5 position or the 7 position and expressly teaches
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and
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at the 7 position. Thus, it would have been obvious to utilize these modifications as they are both aromatic hydrophobic modification. There is a reasonable expectation of success as both patent ‘482 and Levy teach the use of the modified nucleotides specifically C-5 modified uridine and Levy teaches that the modification can be a phenyl or biphenyl or phenoxybenzyl.
Regarding the claimed structure, deoxyuridine results in X of H, R2 of OH and R3 of OH which reads on Formula IB and Formula IIB. As shown in the structure above, attachment of the biphenyl or the phenoxybenzene results in L of CH2 wherein n is 1. These structures read on PBn-U and POP-U of claim 20.
Regarding claims 23, 26, 37, 40 and 42, Patent ‘482 claims aptamers which contain more than one modification and that the aptamer targets a protein (reading on instantly elected target).
Regarding claim 44, Levy teaches compositions. 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 ‘482, Wolk et al. and Levy and utilize a carrier to transport the oligonucleotide.
Regarding claim 77, the BRI of the claim is a kit comprising the compound of claim 9. The additional language recited in claim 77 follows the word optionally which is interpreted as not requiring anything following the optionally recitation.
Claims 9-10, 13, 15-16, 19-20, 23, 26, 33, 37, 40, 42, 44 and 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 8975388 in view of Wolk et al. (Nucleic acids, 2015) and (Levy (WO2015066001). 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 are set forth above.
Patent ’388 claim an aptamer comprising at least one base-modified nucleotide which has the following structure:
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(claim 1). The target as claimed is a protein. The aptamer comprises at least two base modified nucleotides (claim 16).
While Patent ‘382 claims a naphthyl modified uridine, Patent ‘382 does not claim
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. However, this deficiency is cured by Wolk et al. Levy.
The teachings of Wolk et al. are set forth above.
The teachings of Levy 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 ‘388, Wolk et al. and Levy and utilize hydrophobic modifications such as
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in place of the naphthyl modification in patent ‘388. Wolk et al. teaches the use of an amide (C(O)NH) to attach various hydrophobic groups to uridine which coincide with the amide linker claimed by patent ‘388. Levy teaches modifications at the 5 position of deoxyuridine and that these modifications include benzyl or naphthyl as well as biphenyl and phenoxybenzene. Levy teaches that the same modifications can occur at the 5 position or the 7 position and expressly teaches
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and
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at the 7 position. Thus, it would have been obvious to utilize these modifications as they are both hydrophobic aromatic modification. There is a reasonable expectation of success as both patent ‘388 and Levy teach the use of the modified nucleotides specifically C-5 modified uridine and Levy teaches that the modification can be a phenyl or biphenyl or phenoxybenzyl.
Regarding the claimed structure, deoxyuridine results in X of H, R2 of OH and R3 of OH which reads on Formula IB and Formula IIB. As shown in the structure above, attachment of the biphenyl or the phenoxybenzene results in L of CH2 wherein n is 1. These structures read on PBn-U and POP-U of claim 20.
Regarding claims 23, 26, 37, 40 and 42, Patent ‘388 claims aptamers which contain more than one modification and that the aptamer targets a protein (reading on instantly elected target).
Regarding claim 44, Levy teaches compositions. 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 ‘388, Wolk et al. and Levy and utilize a carrier to transport the oligonucleotide.
Regarding claim 77, the BRI of the claim is a kit comprising the compound of claim 9. The additional language recited in claim 77 follows the word optionally which is interpreted as not requiring anything following the optionally recitation.
Claims 9-10, 13, 15-16, 19-20, 23, 26, 33, 37, 40, 42, 44 and 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11111495 in view of Wolk et al. (Nucleic acids, 2015) and (Levy (WO2015066001). 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 are set forth above.
Patent ‘495 claims
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While Patent ‘495 claims a benzyl or naphthyl modified uridine, Patent ‘495 does not claim
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. However, this deficiency is cured by Wolk et al. and Levy.
The teachings of Wolk et al. are set forth above.
The teachings of Levy 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 ‘495, Wolk et al. and Levy and utilize hydrophobic modifications such as
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as the “a benzyl” modification in patent ‘495. Wolk et al. teaches the use of an amide (C(O)NH) to attach various hydrophobic groups to uridine which coincide with the amide linker claimed by patent ‘495. Levy teaches modifications at the 5 position of deoxyuridine and that these modifications include benzyl or naphthyl as well as biphenyl and phenoxybenzene. Levy teaches that the same modifications can occur at the 5 position or the 7 position and expressly teaches
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at the 7 position. Thus, it would have been obvious to utilize these modifications as they are both “a benzyl” modification. There is a reasonable expectation of success as both patent ‘495 and Levy teach the use of the modified nucleotides specifically C-5 modified uridine and Levy teaches that the modification can be a phenyl or biphenyl or phenoxybenzyl.
Regarding the claimed structure, deoxyuridine results in X of H, R2 of OH and R3 of OH which reads on Formula IB and Formula IIB. As shown in the structure above, attachment of the biphenyl or the phenoxybenzene results in L of CH2 wherein n is 1. These structures read on PBn-U and POP-U of claim 20.
Regarding claims 23, 26, 37, 40 and 42, Patent ‘495 claims aptamers which contain more than one modification and that the aptamer targets a protein (reading on instantly elected target).
Regarding claim 44, Levy teaches compositions. 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 ‘495, Wolk et al. and Levy and utilize a carrier to transport the oligonucleotide.
Regarding claim 77, the BRI of the claim is a kit comprising the compound of claim 9. The additional language recited in claim 77 follows the word optionally which is interpreted as not requiring anything following the optionally recitation.
Claims 9-10, 13, 15-16, 19-20, 23, 26, 33, 37, 40, 42, 44 and 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12098370 in view of Wolk et al. (Nucleic acids, 2015) and (Levy (WO2015066001). 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 are set forth above.
Patent ‘370 claims
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While Patent ‘370 claims a naphthyl modified uridine, Patent ‘370 does not claim
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. However, this deficiency is cured by Wolk et al. and Levy.
The teachings of Wolk et al. are set forth above.
The teachings of Levy 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 ‘370, Wolk et al. and Levy and utilize hydrophobic modifications such as
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in place of the naphthyl modification in patent ‘370. Wolk et al. teaches the use of an amide (C(O)NH) to attach various hydrophobic groups to uridine which coincide with the amide linker claimed by patent ‘370. Levy teaches modifications at the 5 position of deoxyuridine and that these modifications include benzyl or naphthyl as well as biphenyl and phenoxybenzene. Levy teaches that the same modifications can occur at the 5 position or the 7 position and expressly teaches
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at the 7 position. Thus, it would have been obvious to utilize these modifications as they are both hydrophobic modification. There is a reasonable expectation of success as both patent ‘370 and Levy teach the use of the modified nucleotides specifically C-5 modified uridine and Levy teaches that the modification can be a phenyl or biphenyl or phenoxybenzyl.
Regarding the claimed structure, deoxyuridine results in X of H, R2 of OH and R3 of OH which reads on Formula IB and Formula IIB. As shown in the structure above, attachment of the biphenyl or the phenoxybenzene results in L of CH2 wherein n is 1. These structures read on PBn-U and POP-U of claim 20.
Regarding claims 23, 26, 37, 40 and 42, Patent ‘370 claims aptamers which contain more than one modification and that the aptamer targets a protein (reading on instantly elected target).
Regarding claim 44, Levy teaches compositions. 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 ‘370, Wolk et al. and Levy and utilize a carrier to transport the oligonucleotide.
Regarding claim 77, the BRI of the claim is a kit comprising the compound of claim 9. The additional language recited in claim 77 follows the word optionally which is interpreted as not requiring anything following the optionally recitation.
Claims 9-10, 13, 15-16, 19-20, 23, 26, 33, 37, 40, 42, 44 and 77 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11-14, 24, 27-29 of copending Application No. 18952065 (US 20250129373) in view of Wolk et al. and Levy. 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 are set forth above.
Copending ‘065 claims an aptamer comprising at least one first 5-position modified pyrimidine and at least one second 5-position modified pyrimidine wherein the 5-position modified pyrimidine can be a uridine and comprises a moiety at the 5-position of naphthyl, a benzyl moiety, etc. (claim 1). A composition comprising a plurality of polynucleotides with the modification is claimed (claim 12). A target being a protein is claimed (claim 29).
While copending ‘065 claims a benzyl or naphthyl modified uridine, copending ‘065 does not claim
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. However, this deficiency is cured by Wolk et al. and Levy.
The teachings of Wolk et al. are set forth above.
The teachings of Levy 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 ‘370, Wolk et al. and Levy and utilize hydrophobic modifications such as
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in place of the naphthyl modification in copending ‘065. Wolk et al. teaches the use of an amide (C(O)NH) to attach various hydrophobic groups to uridine which coincide with the amide linker claimed by copending ‘065. Levy teaches modifications at the 5 position of deoxyuridine and that these modifications include benzyl or naphthyl as well as biphenyl and phenoxybenzene. Levy teaches that the same modifications can occur at the 5 position or the 7 position and expressly teaches
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at the 7 position. Thus, it would have been obvious to utilize these modifications as they are both hydrophobic modifications. There is a reasonable expectation of success as both copending ‘065 and Levy teach the use of the modified nucleotides specifically C-5 modified uridine and Levy teaches that the modification can be a phenyl or biphenyl or phenoxybenzyl.
Regarding the claimed structure, deoxyuridine results in X of H, R2 of OH and R3 of OH which reads on Formula IB and Formula IIB. As shown in the structure above, attachment of the biphenyl or the phenoxybenzene results in L of CH2 wherein n is 1. These structures read on PBn-U and POP-U of claim 20.
Regarding claims 23, 26, 37, 40 and 42, copending ‘065 claims aptamers which contain more than one modification and that the aptamer targets a protein (reading on instantly elected target).
Regarding claim 44, Levy teaches compositions. 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 ‘065, Wolk et al. and Levy and utilize a carrier to transport the oligonucleotide.
Regarding claim 77, the BRI of the claim is a kit comprising the compound of claim 9. The additional language recited in claim 77 follows the word optionally which is interpreted as not requiring anything following the optionally recitation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached on 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636
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