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 drawn to a polynucleotide, Structure II, single stranded, LNA, beta-D-oxy LNA, IIb, SEQ ID No: 4 in the reply filed on November 12 2025 is acknowledged.
Although the response indicates that the sequence elected for claim 33 is SEQ ID NO: 4, this sequence includes goxo which is 8-oxo-deoxyguanosine which corresponds to structure I. However, Applicants elected structure II.
The examiner contacted Applicants representative, Daniel Shelton, on January 22 2026 to discuss the election of the sequence and the confusion. Mr. Shelton agreed to switching the election to SEQ ID NO: 6 which actually contains the elected gPPG. Upon searching, the examiner has expanded to the species election to also include SEQ ID No: 10 which was found to be co-extensive.
The response filed November 12 2025 has amended claims 38-39 to be directed to methods of treating which are independent or distinct from the invention originally claimed for the following reasons:
Group VI, Claim 37, drawn to a method for treating a medical condition in a subject in need thereof wherein modulation of Ube3A is beneficial.
Group VII, Claim 38, drawn to a method for treating a medical condition in a subject in need thereof wherein modulation of ATXN2 is beneficial.
Group VIII, Claim 39, drawn to a method for treating a medical condition in a subject in need thereof wherein modulation of ATXN3 is beneficial.
Group IX, Claim 40, drawn to a method for reducing neurotoxicity in a subject in need thereof.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the reasons set forth in the Restriction Requirement mailed on July 16 2025.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Note MPEP 818.02(a) which states: Where claims to another invention are properly added and entered in the application before the earlier of the mailing of a first restriction requirement or the mailing of a first Office action on the merits, those claims, along with the ones presented upon filing the application, will be considered originally presented claims for purposes of restriction only.(emphasis added).
Accordingly, claims 37-40 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1-46 are pending in the application. Claims 4-5, 9, 11-17, 19-24 and 37-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 12 2025. Accordingly, claims 1-3, 6-8, 10, 18 and 25-36 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/EP2021/065266 (06/08/2021) which claims priority to EUROPEAN PATENT OFFICE (EPO) 20179011.0 (06/09/2020) as reflected in the filing receipt issued on November 17 2025.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 14 2023 and June 27 2025 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) indicates when there is only one drawing, it must not be numbered and the abbreviation FIG must not appear. In the current case, the application contains only one figure. Therefore, the figure must be not labeled or be labeled as Figure or The Figure.
The examiner notes that correction to the drawing must also include a correction to the specification, specifically the brief description of the drawings and any other reference to Figure 1.
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.
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 - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because the application does not contain a statement that the CRF is identical to the "Sequence Listing" part of the disclosure, as described above in item 1), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Required response - Applicant must provide such statement.
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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6-8, 10, 18 and 25-36 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 as currently written is vague and indefinite. The claim recites a guanosine analog of Formula I or II (shown below):
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. The scope of the structure is not clear. Specifically it isn’t clear what the squiggly line is intended to mean. As taught by UCLA (see chem.ucla.edu, attached to this office action). A wavy line (squiggly line) means (1) a molecular structure beyond this point is unspecified or unimportant (aka it indicates a point of attachment) or (2) a mixture of isomers. It isn’t clear what the squiggly line in Formula I or II means. Neither the claims nor the specification provide a limiting definition. As set forth in Chem.UCLA.edu when it is intended to mean the point of attachment then the squiggly line crosses a bond:
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which does not appear to be the way the bond is used in the structure above. Therefore, the other interpretation is that it is a mixture of stereoisomers and the bond has a methyl (aka CH3) in either the R or S configuration. But the guanosine analogue is intended to be part of a polynucleotide in the claims so having a methyl group of unspecified configuration would not make sense as it pertains to the use in a larger molecule. Therefore, the claim is indefinite as it appears that this is supposed to be signifying the point of attachment but the squiggly line is not used in the conventional manner for this indication and nothing in the claims or specification clarify the meaning.
Claim 10 is also indefinite for the reasons set forth above for the squiggly line.
Claims 2-3, 6-8, 18 and 25-36 are included in the rejection as they depend on a rejected base claim and they do not clarify the issues.
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, 6-8, 10, 18, 26 and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Srivastava et al. (USPGPUB No. 20110137010) in view of Kutyavin et al. (Nucleic Acids Research, 2002, cited on PTO Form 1449).
Applicant Claims
The instant application claims a polynucleotide that comprises: at least one phosphorothioate internucleoside linkage and at least a guanosine analogue which as elected is:
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Wherein the squiggly line is interpreted by the examiner as being the point of attachment to a sugar which would correspond to Structure IIb as elected:
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Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Srivastava et al. is directed to phosphoramidites for synthetic RNA in the reverse direction, efficient RNA synthesis and convenient introduction of 3’-end ligands, chromophores and modifications of synthetic RNA. Claimed is a compound of formula Ic:
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wherein J can be H, R6 is H or O-Z wherein Z is an acid labile protecting group (i.e. a group that gets cleaved for synthesis of the oligonucleotide) and Bn is a hydrogen or nucleobase selected from a list which includes 7-deaza-8-azaguanine (claim 1). It is taught that 7-deaza-2’-deoxy nucleosides can be incorporated within the RNA sequence in place of a dGuanosine base. This modification has many significant biological properties for diagnostic and therapeutic filed of DNA and RNA (paragraph 0297-0298). RNA molecules which incorporate the compounds is claimed (claim 39). Exemplified oligonucleotides have phosphorothioate linkages (Figs 2A-2D; claim 29, 31; paragraph 0370). It is taught that the Reverse RNA synthesis can be used in RNAi (RNA interference) synthesis (paragraph 0376). The phosphoramidate oligos have been shown to help in design and efficacy of oligonucleotides for gene regulation, gene expression, antisense etc. (paragraph 0309). Incorporation of locked amino acids via reverse RNA synthesis is taught (paragraph 0309).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Srivastava et al. teaches 7-deaza-8-azaguanine, Srivastava et al. does not expressly provide motivation for selecting this base from the list taught. However, this deficiency is cured by Kutyavin et al.
Kutyavin et al. is directed to reduced aggregation and improved specificity of G-rich oligodeoxyribonucleotides containing pyrazole[3,4-d]pyrimidine guanine bases. It is taught that G-rich oligonucleotides (ODNs) can cause problems in DNA synthesis. Unwanted aggregation can plague studies that assume ODNs behave as single strand with predictable hybridization performance. Results show that PPG (8-aza-7-deazaguanine) when substituted for G can significantly reduce self-association. Data demonstrates improved mismatch discrimination properties of PPG-containing ODNs. The substitution of G with PPG could be beneficial in the case of relatively stable mismatches where G is involved (conclusions).
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 Srivastava et al. and Kutyavin et al. and utilize PPG (aka 8-aza-7-deaxaguanine) as the base in the compound of formula Ic in Srivastava et al. One skilled in the art would have been motivated to choose PPG as it can reduce unwanted aggregation and/or self-association during synthesis and can be beneficial in forming relatively stable mismatches as taught by Kutyavin et al. One skilled in the art would have had a reasonable expectation of success as Srivastava et al. suggests that the base can be 8-aza-7-deaxaguanine. Therefore, to arrive at the claimed guanosine analogue one skilled in the art would have only needed to select 8-aza-7-deaxaguanine from a finite list of possible choices for the base.
Regarding the claimed polynucleotide, Srivastava et al. teaches incorporation of the compounds into polynucleotides. Exemplified oligonucleotides have phosphorothioate linkages. Therefore, incorporation of the compound Ic wherein the base is 8-aza-7-deazaguanine into the polynucleotide would result in the instantly claimed polynucleotide.
Regarding claims 6-8, 10 and18 as set forth above compound 1c with the 8-aza-7-deazaguanine base would result in a locked nucleic acid, specifically, beta-D-oxy LNA: compound IIb.
Regarding claims 2, 26 and 29-32, exemplified sequences include those with phosphorothioates and contain multiple G nucleotides (paragraph 0440). 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 Srivastava et al. and Kutyavin et al. and utilize PPG (aka 8-aza-7-deaxaguanine) with all the G located in the particular oligonucleotide sequence. One skilled in the art would have been motivated to replace all the G nucleotides (e.g. 1, 2, 3, 4 or more) with PPG in order to reduce aggregation and improved specificity of G-rich oligodeoxyribonucleotides as taught by Kutyavin et al.
Claims 2-3, 25-29 and 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Srivastava et al. in view of Kutyavin et al. as applied to claims 1-2, 6-8, 10, 18, 26 and 29-32 above and in further view of Costa et al. (USPGPUB No. 20170191064).
Applicant Claims
The instant application claims the polynucleotide is an antisense oligonucleotide. The instant application claims the antisense oligonucleotide is a gapmer. The instant application claims a pharmaceutical formulation comprising the polynucleotide and a pharmaceutically acceptable diluent, solvent, carrier, salt and/or adjuvant. The instant application claims the formulation is suitable for administration to the central nervous system or for treatment of a neurological disorder. The instant application claims the formulation is suitable for administration via intrathecal injection.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teachings of Srivastava et al. and Kutyavin et al. are set forth above.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Srivastava et al. suggests incorporation into oligonucleotides and teaches the phosphoramidate oligos have been shown to help in design and efficacy of oligonucleotide’s for gene regulation, gene expression or antisense, Srivastava et al. does not expressly teach an antisense gapmer or pharmaceutical composition comprising the oligonucleotides. However, these deficiencies are cured by Costa et al.
Costa et al. is directed to oligonucleotides for inducing paternal ube3a expression. Claimed is an antisense oligonucleotide which comprises a contiguous nucleotide sequence of 10 to 30 nucleotides in length with at least 98% complementarity to position 25278410 to 25419462 on human chromosome 15 (claim 1). The oligonucleotides comprises one or more modified nucleosides (claim 5). The modifications are a LNA nucleoside (claim 8; paragraph 0053-0054). The oligonucleotide is a gapmer (claim 12). Sequences specifically taught (Table 3) include:
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Claimed is a pharmaceutical composition comprising the oligonucleotide and a pharmaceutically acceptable diluent, solvent, carrier, salt and/or adjuvant (claim 16). The oligonucleotides can be administered via intrathecal administration (paragraph 026-0268). The oligonucleotide can comprise one or more modified nucleosides or nucleotides (paragraph 0016; 0031). Nuclease resistant linkages, such as phosphorothioate linkages, are useful in oligonucleotide regions capable of recruiting nuclease when forming a duplex with the target nucleic acid, such as region G for gapmers (paragraph 0028).
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 Srivastava et al., Kutyavin et al. and Costa et al. and utilize the compound of Srivastava et al. with the PPG (aka 8-aza-7-deaxaguanine) nucleobase in the oligonucleotide of Costa et al. One skilled in the art would have been motivated to utilize this oligonucleoside as Srivastava et al. suggests it use in the synthesis of oligonucleotides. Since Costa et al. teaches the inclusion of modified nucleobases as well as modified sugars and specifically teaches the use of a locked nucleic acid (LNA) there is a reasonable expectation of success. Since the nucleoside is a guanine, it would be obvious to use the modified nucleoside at any G in the oligonucleotide sequence of Costa et al.
Regarding the claimed phosphorothioate internucleoside linkage, Costa et al. teaches nuclease resistant linkages, such as phosphorothioate linkages, are useful in oligonucleotide regions capable of recruiting nuclease when forming a duplex with the target nucleic acid, such as region G for gapmers. Since Srivastava et al. also teaches phosphorothioate linkages, there is a reasonable expectation of success.
Regarding claim 3 and 25, Costa et al. teaches the oligonucleotides are antisense gapmers.
Regarding claims 27-28 and the claimed sequences of claim 33, as set forth above Costa et al. teaches the use of oligonucleotides of 10 to 30 nucleotides in length with at least 98% complementarity to position 25278410 to 25419462 on human chromosome 15. Table 3 teaches specific oligonucleotides and their corresponding position on the chromosome.
As set forth above instantly claimed SEQ ID NO: 6 (Qy) has 100% identity to SEQ ID NO: 95 (Db) of Costa et al.
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And SEQ ID No: 10 (Qy) has 100% identity to SEQ ID No: 100 (Db) of Costa et al.
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The sequences contain the same sequence identity as well as the same capital letters which Costa et al. teaches represent beta-D-oxy-LNA nucleosides, lowercase letters present DNA nucleosides and all LNA C are 5-methyl cytosine (0416) which is the same definition as claim 33. Therefore, replacement of the G in the sequence, which is obvious for the reasons set forth above, would result in the same sequence.
Regarding claim 34-36, Costa et al. expressly claims a pharmaceutical composition comprising the oligonucleotide and a diluent, solvent, carrier, etc. 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 Srivastava et al., Kutyavin et al. and Costa et al. and utilize a composition, specifically a carrier and the oligonucleotide, in order to formulate a composition which can be delivered intrathecally. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2143 KSR International Co. v. Teleflex Inc., 550 US 398, 82 USPQ 2d 1385 (2007).
Furthermore, regarding claims 35-36, these claims are directed to the intended use of the pharmaceutical formulation. A recitation of the intended use of the claimed invention, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02 and MPEP 2145. Costa et al. teaches the pharmaceutical composition with a carrier and that the composition can be administered intrathecally. Therefore, it is clearly taught as being suitable for administration to the CNS and suitable for administration via intrathecal injection.
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 1-3, 6-8, 26, 29 and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9-10, 13-15, 17-18, 21, 25 and 41 of copending Application No. 18170685 (USPGPUB No. 20240167040). 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 polynucleotide that comprises: at least one phosphorothioate internucleoside linkage and at least a guanosine analogue which as elected is:
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(aka PPG).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending ‘685 claim an antisense oligonucleotide of 12 to 30 nucleotides in length (claim 1). The antisense oligonucleotide is a single stranded antisense oligonucleotide (claim 9). The antisense oligonucleotide includes one or more sugar modified nucleosides wherein the motivation can be a LNA nucleoside (claim 15). Claimed are specific oligonucleotides with specific patterns. These oligonucleotides include LR (beta-D-oxy-LNA nucleoside) as well as PPG (7-deaza-8-aza guanine nucleobase) and phosphorothioates (sP) see for example sequence t (SEQ ID No: 14) (claim 25). A pharmaceutical composition comprising the antisense oligonucleotide and a pharmaceutically acceptable diluent, solvent, carrier, salt and/or adjuvant is claimed (claim 41).
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as the claimed sequences are polynucleotides that contain at least one phosphorothioate and a guanine analogue of Structure II (aka PPG).
Regarding claims 2-3, the oligonucleotide is an antisense oligonucleotide.
Regarding claims 6-8 and 26, LNA are claimed.
Regarding claim 29, SEQ ID No: 14 contains one guanosine analogue.
Regarding claim 34-36, copending ‘685 claims a pharmaceutical composition comprising the antisense oligonucleotide and a pharmaceutically acceptable diluent, solvent, carrier, salt and/or adjuvant. Furthermore, regarding claims 35-36, these claims are directed to the intended use of the pharmaceutical formulation. A recitation of the intended use of the claimed invention, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02 and MPEP 2145.
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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/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636