Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Application/Amendment/Claims
Applicant's response filed 12/10/2025 has been considered. Rejections and/or objections not reiterated from the previous office action mailed 09/10/2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
With entry of the amendment filed on 12/10/2025, claims 18-34 and 38-45 are pending and currently under examination. SEQ ID Nos. 91-118 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
New Claim Rejections – necessitated by claim amendments
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.
New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 18 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 18 recites “wherein said ASO is able to hybridize to a (CAG)n repetitive nucleotide unit by only forming Watson-Crick base pairs” and appears to depart from the claims are originally filed and is therefore considered new matter. The specification does not describe the claimed antisense as only forming Watson-Crick base pairs and describes Watson-Crick base pairs in the context of binding of “adenine analogs”, “uracil analogues”, “cytosine analogues” and “guanine analogs” and does not describe these base pairs as only forming Watson-Crick base pairs (page 60).
Further the claim limitation is a negative limitation which does not appear to have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. (See MPEP 2173.05(i). The specification under Definitions recites "hybridization" refers to the pairing of complementary oligomeric compounds (e.g., an antisense compound and its target nucleic acid). While not limited to a particular mechanism, the most common mechanism of pairing involves hydrogen bonding, which may be Watson-Crick, Hoogsteen or reversed Hoogsteen hydrogen20 bonding between complementary nucleoside or nucleotide bases (nucleobases). The new claim limitation is an attempt to exclude wobble base pairing in the prior art which is not recited in the specification. It is therefore an attempt to claim the invention by excluding what the inventors did not invent rather than distinctly and particularly pointing out what they did invent.
If Applicant believes that such support is present in the specification and claimed priority documents, Applicant should point, with particularity, to where such support is to be found.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 18-34 and 38-45 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over De Kimpe et al. (US 2011/0184050 of record cited on 892 mailed 09/10/2025) , Swayze et al. ("The medicinal chemistry of oligonucleotides." Antisense Drug Technology. CRC Press, 2007. 161-200), Aguilera Diez et al. (US 2014/0045763 of record cited on 892 mailed 09/10/2025), Corey et al. (US 20130059903) and De Visser et al. (US 20150045413 of record cited on 892 mailed 09/10/2025).
This rejection is a new rejection that includes new prior art but still contains the previous rejection and was modified due to claim amendments and new claims.
De Kimpe et al. teach methods for treating DNA repeat instability disorders using short nucleic acids targeted to the expanded repeat region (see in particular paragraphs 11-15), where in the nucleic acids can be used to treat any "cis-element repeat instability associated genetic disorder". Said disorder is preferably any disease wherein an allele of a given gene comprises a repetitive sequence which is a so-called unstable repetitive sequence, since the number of repeats present in said repetitive sequence will increase or expand in time during the development of said disease (para 0014). De Kimpe et al. teach that oligonucleotides comprising or consisting of a sequence complementary to a polyglutamine (CAG)n tract in a transcript is particularly useful for the diagnosis, treatment and/or prevention of Huntington’s disease (HD) (see para 27). De Kimpe et al. teach the oligonucleotides can comprise natural nucleotide bases or derivatives such as 2-aminopurine, thymidine instead of uracil, 5-methylcytosine, 5-methylinosine, 7-methylguanosine or diaminoadenine and includes phosphorothioate moieties (see para 35). This meets some of the limitations of claims 18, 25, 26 and 38-42.
De Kimpe et al. teach the oligonucleotide can comprise 9-50 nucleotides or preferably comprise 4-14 nucleotides (see para 0026). De Kimpe et al. teach the oligonucleotide was capable of inhibiting a huntingtin transcripts with expanded CAG repeats (see Example 2). Reducing mutant protein would inherently reduce protein aggregates of instant claim 30. De Kimpe et al. further teach the composition contains an excipient that will aid in delivery of the oligonucleotide to the cell and pharmaceutical compositions (0060). This meets the limitations of claim 20 and 30-34.
De Kimpe et al. teach use of a sequence consisting of the sequence (CUG)7, designated as PS57 (see Table 1), which is identical to instant SEQ ID NO: 90. This sequence is a 2’-O-methyl RNA with a phosphorothioate backbone. The sequence PS57 differs from the sequence recited in the instant claims by not comprising 5-methylcytosine and/or 5-methyluracil. However, De Kimpe et al. describes the use of modifications such as 5-methylcytosine (see para 35). De Kimpe et al. demonstrates PS57 administered to fibroblasts from Huntington’s disease was capable of inhibition of the mutant transcript (see Figures 2-5). This sequence does not have an inosine or a nucleotide that would form a wobble base pair and thus would meet the limitations of “wherein said ASO is able to hybridize to a (CAG)n repetitive nucleotide unit by only forming Watson-Crick base pairs”. This meets the limitations of claim 18, 20-24, 44, 45.
Swayze et al. teach the C5 position has been one of the most common places for chemical manipulations on pyrimidine heterocycles, as modification of this site has little effect on Watson–Crick base pairing and because of the affinity increase of the 5-methyl group, combined with reduction in immunostimulatory toxicities [202], 5-methylcytosine is broadly used in place of cytosine for most modified “C” nucleosides (see pages 163-164).
The prior art of Aguilera Diez et al. describes methods for treating, delaying and/or preventing a human genetic disorder such as HD, caused by CUG repeats, using an oligonucleotide (see abstract). Aguilera Diez et al. teach oligonucleotides of lengths of 12-90 and has at least 90% reverse complementary to a CUG repeat (see 0100). Aguilera Diez et al. teach said oligonucleotide preferably comprises a modified base which is expected to provide a compound or an oligonucleotide of the invention with an improved RNA binding kinetics and/or thermodynamic properties, provide a compound or an oligonucleotide of the invention with a decreased or acceptable level of toxicity and/or immunogenicity, and/or enhance pharmacodynamics, pharmacokinetics, activity, allele selectivity, cellular uptake and/or potential endosomal release of the oligonucleotide or compound of the invention (see para 0045). Aguilera Diez et al. teach preferred base modification can be at least one or more of -5-methylcytosine and/or 5-methyluracil (see para 0075-0080 and claim 14). (These limitations have priority to the 61/478,096 application on pages 3-4 as explained below). This meets the limitans of claims 18, 21-24, 28, 29 and 38-42.
Corey et al. teach oligonucleotides that are capable of hybridizing to repeat regions of CAG in treatment of Huntington’s disease (0005). Corey et al. teach an oligonucleotides comprising all base modifications having 5-methylcytosine were efficient at inhibition of mutant protein (see Example 11, 0030 and Table 18). This meets some of the limitations of claims 18 and 19.
Regarding claim 27, De Visser et al. teach what is well known in the art regarding inhibitory oligonucleotides and the ability to still target and inhibit expression when the complementarity or mismatched nucleotide to target sequence is less than 100%. De Visser et al. teach antisense compounds that may comprise up to about 20% nucleotides that are mismatched (i.e., are not nucleobase complementary to the corresponding nucleotides of the target). Preferably the antisense compounds contain no more than about 15%, more preferably not more than about 10%, most preferably not more than 5% or no mismatches. The remaining nucleotides are nucleobase complementary or otherwise do not disrupt hybridization (e.g., universal bases). One of ordinary skill in the art would recognize the compounds provided herein are at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99% or 100% complementary to a target nucleic acid. Thus one of skill in the art would have expected the oligonucleotide to remain bound to the target when there is about 20% nucleotides that are mismatched.
It would have been obvious for one of ordinary skill in the art to modify the oligonucleotide taught by De Kimpe et al. with the base modifications taught by Swayze et al., Aguilera Diez et al. and Corey et al., particularly given De Kimpe et al. teach the use of base modification such as 5-methylcytosine, Swayze et al. teach base modifications, such as 5-methylcytosine are well known, Diez et al. teach preferred base modifications of both 5-methylcytosine and 5-methyluracil and given Corey et al. teach oligonucleotides comprising all base modifications having 5-methylcytosine were efficient at inhibition of mutant protein. Further, one of skill would have wanted to use the oligonucleotide PS57 of De Kimpe given it was shown to be capable of efficiently inhibiting mutant protein and would have been capable of modifying the oligonucleotide because Aguilera Diez et al. teach base modification, as claimed, provides advantages such as a decreased or acceptable level of toxicity and/or immunogenicity, and/or enhance pharmacodynamics, pharmacokinetics, activity, allele selectivity, cellular uptake and/or potential endosomal release of the oligonucleotide or compound of the invention.
Given the art teach preferred base modifications of 5-methycytosine and 5-methyuridine, one of skill in the art would have been capable of making the oligonucleotide with all X as 5-methycytosine and all Y as 5-methyuridine or variations of them both to find the optimal modified oligonucleotide with improved stability. One of skill in the art would have expected the modified oligonucleotide would have an improvement as compared to an oligonucleotide without the base modifications and be useful in methods of treating, delaying, ameliorating, and/or preventing Huntington’s disease.
Moreover, because it was known in the art regarding the need for enhanced stability and decreased toxicity of oligonucleotides for use in methods of treatment and because Aguilera Diez et al. teach a preferred base modification can be selected from a finite group such as 5-methylcytosine and/or 5-methyluracil, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. Thus, after KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
One of skill in the art would have expected to be capable of treating, delaying, ameliorating, or preventing Huntington’s disease in a subject and thus, the claimed invention would have been obvious in view of the cited references.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 18-34 and 38-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,745,576. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to an oligonucleotide comprising (XYG)7 wherein each X is 5-methyl cytosine and each Y is uracil or wherein each X is cytosine and each Y is 5-methyluracil. The sequence wherein X is 5-methyl cytosine and each Y is uracil is identical to instant SEQ ID NO: 90. This sequence does not have an inosine or a nucleotide that would form a wobble base pair and thus would meet the limitations of ‘wherein said ASO is able to hybridize to a (CAG)n repetitive nucleotide unit by only forming Watson-Crick base pairs”
The patent claims further recite a method of using this oligonucleotide to treat a disorder associated with human cis-element repeats which reads on the instant claims. It would have been obvious to use the oligoribonucleotide in the instant methods of treatment. The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application.
Claims 18-34 and 38-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,345,915. Although the claims at issue are not identical, they are not patentably distinct from each other because to methods for treating delaying ameliorating and/or preventing a human cis-element repeat instability associated genetic disorder in a subject using an oligonucleotide hybridizing to CAG repetitive units wherein the oligonucleotide comprises SEQ ID No. 90. This sequence does not have an inosine or a nucleotide that would form a wobble base pair and thus would meet the limitations of ‘wherein said ASO is able to hybridize to a (CAG)n repetitive nucleotide unit by only forming Watson-Crick base pairs”
Claims 18-34 and 38-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of US Application No. 18/752,689. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to an oligonucleotide comprising (XYG)m wherein each X is 5-methyl cytosine and each Y is uracil or wherein each X is cytosine and each Y is 5-methyluracil. The sequence wherein X is 5-methyl cytosine and each Y is uracil is identical to instant SEQ ID NO: 90. This sequence does not have an inosine or a nucleotide that would form a wobble base pair and thus would meet the limitations of ‘wherein said ASO is able to hybridize to a (CAG)n repetitive nucleotide unit by only forming Watson-Crick base pairs”
The patent claims further recite a method of using this oligonucleotide to treat a disorder associated with human cis-element repeats which reads on the instant claims. It would have been obvious to use the oligoribonucleotide in the instant methods of treatment. The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application.
Response to Arguments and Amendments
Applicant’s arguments have been considered but are not persuasive to overcome the 103 rejection above. Applicant argues the currently amended claims specify the hybridization is only by forming Watson-Crick base pairs however as stated above, De Kimpe et al. teach PS57 which is identical to SEQ ID No. 90 without 5-methycytosine and this sequence does not have an inosine or a nucleotide that would form a wobble base pair and thus would meet the limitations of “wherein said ASO is able to hybridize to a (CAG)n repetitive nucleotide unit by only forming Watson-Crick base pairs”.
Applicant argues De Kimpe is directed to methods that apply an oligonucleotide comprising an inosine or a nucleotide containing a base to form a wobble base pair and emphasizes that the disclosed oligonucleotides preferably comprising a wobble bases such as inosines. While De Kimpe does in fact state the oligonucleotides of the invention preferably contain inosine or a nucleotide that would form a wobble base pair, De Kimpe also teach using the oligonucleotide PS57, which does not have inosine or a nucleotide that would form a wobble base pair and which shows efficient inhibition of mutant protein. The 103 rejection is based on this particular oligonucleotide which meets the amended claim limitations. So it appears De Kimpe et al. teach more than the preferred oligonucleotide and as stated in MPEP 2123, "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Moreover, “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971)”. Therefore De Kimpe teaching a preferred use of inosine or a nucleotide that would form a wobble base pair is not a teaching away because the reference is relevant art for all that it contains.
Applicant argues Diez et al. is not prior art because the relevant disclosure relied upon by the Examiner is not prior art because the 61/478,096 application does not contain support for the relevant part cited in the Office Action. In response Diez et al. the priority document 61/478,096, filed 04/22/2011, does provide support.
The Examiner cited Diez for teaching the oligonucleotide preferably comprises a modified base which is expected to provide a compound or an oligonucleotide of the invention with an improved RNA binding kinetics and/or thermodynamic properties, provide a compound or an oligonucleotide of the invention with a decreased or acceptable level of toxicity and/or immunogenicity, and/or enhance pharmacodynamics, pharmacokinetics, activity, allele selectivity, cellular uptake and/or potential endosomal release of the oligonucleotide or compound of the invention (see para 0045). Aguilera Diez et al. teach preferred base modification can be at least one or more of -5-methylcytosine and/or 5-methyluracil (see para 0075-0080 and claim 14).
The 61/478,096 application teach on pages 3-4 recite An oligonucleotide part of the compound of the invention preferably comprises a modified base as identified above since it is expected to provide a compound with an improved RNA binding kinetics and/or thermodynamic properties, provide a compound with a decreased or acceptable level of toxicity and/or immunogenicity, and/or enhance pharmacodynamics, pharmacokinetics, cellular uptake and/or potential endosomal release of the oligonucleotide part of the compound of the invention are present. In a more preferred embodiment, one or more 2-thiouracil, 2-thiothymine, 5 methylcytosine, 5-methyluracil, thymine, 2,6-diaminopurine bases is present in said oligonucleotide part. Therefore Diez et al. is prior art with support in the 61/478,096 application.
Applicant further argues the ‘096 application does not provide guideposts to direct one of ordinary skill in the art to the ASO’s of the claimed methods and provides no direction as to what extent oligonucleotide modifications would be effective for treating Huntington’s disease. In response, the modifications are not described in the art or the claimed invention to be added to the oligonucleotide to be effective for treating the disease. The modifications are described in the art to provide a compound or an oligonucleotide of the invention with a decreased or acceptable level of toxicity and/or immunogenicity, and/or enhance pharmacodynamics, pharmacokinetics, activity, allele selectivity, cellular uptake and/or potential endosomal release of the oligonucleotide or compound of the invention. Further the teachings of Diez by way of the ‘096 application provide the skilled artisan with the motivation to modify the oligonucleotide of De Kimpe with preferred embodiments such as 5 methylcytosine and 5-methyluracil and this along with the prior art cited above would make the invention obvious.
Applicant’s arguments against the Double Patenting rejections are not persuasive because each of the Patents claim an oligonucleotide identical to the claimed oligonucleotide and as stated above, this sequence does not have an inosine or a nucleotide that would form a wobble base pair and thus would meet the limitations of “wherein said ASO is able to hybridize to a (CAG)n repetitive nucleotide unit by only forming Watson-Crick base pairs”.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
706.07(a) Final Rejection, When Proper on Second Action [R-07.2015]
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Second or any subsequent actions on the merits shall be final, except where the examiner introduces a new ground of rejection that is neither necessitated by applicant’s amendment of the claims, nor based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p). Where information is submitted in an information disclosure statement during the period set forth in 37 CFR 1.97(c) with a fee, the examiner may use the information submitted, e.g., a printed publication or evidence of public use, and make the next Office action final whether or not the claims have been amended, provided that no other new ground of rejection which was not necessitated by amendment to the claims is introduced by the examiner. See MPEP § 609.04(b).
Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY CHONG at 571-272-3111. The examiner can normally be reached Monday thru Friday 9-5 pm.
If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY CHONG/Primary Examiner, Art Unit 1636