DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/19/2026 has been entered.
Status of the Claims
Claims 24-25, 27-43, 45-48 are pending.
Claims 33-34 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/08/2024.
Claims 24-25, 27-32, 35-43, 45-48 are examined herein.
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 24-25, 27-32, 35-43, 45-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,890,379 (of record). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the ‘379 patent. The instant claims are drawn to a method of treating a cis-element (CAG)n repeat instability disorder in a subject, wherein the subject’s genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence, the method comprising administering to the subject an oligonucleotide consisting of a sequence that is complementary only to a polyglutamate (CAG)n repetitive unit in a gene transcript. The claims of the ‘379 patent are drawn to a method of treating a subject that has a genetic disorder associated with human cis-element repeat instability comprising administering to the subject an oligonucleotide comprising 10 to 50 nucleotides that is complementary to a sequence of a pre-mRNA transcript, said cis-element repeat instability is characterized by CAG repeat instability, said sequence comprising (CAGCAGCAGCAG) SEQ ID NO: 18, said oligonucleotide comprises either ribonucleotides or deoxyribonucleotides, said oligonucleotide comprising a modification selected from the group consisting of: a morpholino phosphorodiamidate oligonucleotide, a phosphorothioate oligonucleotide, a locked nucleic acid (LNA), a peptide nucleic acid (PNA) and an ethylene-bridged nucleic acid, wherein said administered oligonucleotide does not induce RNaseH-mediated degradation of said pre-mRNA transcripts (see claim 1 of the ‘379 patent). Except for the requirement that the subject’s genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence, the instant claimed invention is broader in scope than the claimed invention of the ‘379 patent. Broad genus claims are anticipated by the narrower species which they encompass. Accordingly, the instant broad embodiments of the instant claims are anticipated by the narrower species of the claimed invention of the ‘379 patent. Furthermore, regarding the requirement of at least 50 CAG repeats, it is noted that the specification of the issued patent acknowledges that the diseased state has an increased number of repeat units, explicitly indicating 50 (or more) repeats are found in the diseased state (e.g., see column 1, lines 15-37 (1:15-37) citing the prior art reference Cleary and Pearson, 2003). Therefore, using the specification of the issued patent as a dictionary to define the scope of the claimed invention including obvious variations, it is clear that the broad claim encompasses treating a subject whose genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence. Furthermore, one of ordinary skill in the art would also have known that the claimed method of the patented invention could have been used to treat a subject whose genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence, based on the teachings of Cleary and Pearson (cited in the instant specification).
Regarding claim 27, the requirement that the SCA is SCA type 1, 2, 3, 6, 7 or 17 only limits the disease which is prevented. Regarding claims 38, 39, 40, 41, these claims merely set forth functional limitations of the oligonucleotide used in the method. Since the method set forth in claim 1 of the ‘379 patent meets the requirements of the instant claims, it would necessarily have the same results. Instant claims 30-32 correspond to claims 5-6, 11, 13. Instant claims 27-28 correspond to claims 7-9 of the issued patent. Furthermore, although the claims of the ‘379 patent do not explicitly indicate that the oligonucleotide is provided with an excipient or comprised in a pharmaceutically acceptable composition or that the administration is by a parenteral injection that is one of: intravenous, subcutaneous, intramuscular, intrathecal injection, official notice is taken that it was well known in the prior art to formulate therapeutic compositions in pharmaceutically acceptable compositions with excipients and that the parenteral injections were also well known; therefore, they are obvious variations of the claimed method of the ‘379 patent.
Regarding claims 45-48, the instant specification also indicates that it was known that 100 or more CAG repeats are known to be found in diseased subjects (see 1:15-37, citing Cleary and Pearson); that the uninterrupted CAG repeats are in a transcribed ATXN1 gene sequence, aATXN3 gene sequence, and HD gene sequence (e.g., see 6:22-32); the administration comprises intrathecal injection (see 10:33-47); and that the subject's cells can comprise ribonuclear foci associated with the repeat-expanded transcript, and whereby treating the subject reduces the formation or persistence of the ribonuclear foci (see 12:64 – 13:9 in descriptions of FIG. 9 and FIG. 10 as well as the figures themselves).
Claims 24-25, 27-32, 35-43, 45-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,274,299 (of record). Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a method of treatment as indicated in the rejection above. The claims of the ‘299 patent are drawn to a method of treating a spino-cerebellar ataxia (SCA), spinal and bulbar muscular atrophy (SBMA), or dentatorubral-pallidoluysian atrophy (DRPLA) in a subject in need thereof, comprising administering to the subject an oligonucleotide comprising or consisting of a sequence that is complementary only to a polyglutamine (CAG)n repetitive nucleotide unit in a gene transcript (see claim 1). The instant claims are broader in scope (i.e., treating any genetic disorder associated with a human cis-element (CAG)n repeat instability) than the claims of the ‘299 patent (treating SCA,SBMA or DRPLA using an oligonucleotide complementary only to a CAG repetitive nucleotide unit in a gene transcript), with the exception of the requirement that the subject’s genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence. Accordingly, the broad embodiments claims are anticipated by the claims of the ‘299 patent. With respect to the requirement that the subject’s genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence, using the specification of the issued patent to define the scope and obvious variations of the claims, it is clear that the specification of the issued patent acknowledges that the diseased state has an increased number of repeat units, explicitly indicating 50 (or more) repeats are found in the diseased state (e.g., see 1:50-60) citing the prior art reference Cleary and Pearson, 2003). Therefore, using the specification of the issued patent as a dictionary to define the scope of the claimed invention including obvious variations, it is clear that the broad claim encompasses treating a subject whose genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence. Furthermore, one of ordinary skill in the art would also have known that the claimed method of the patented invention could have been used to treat a subject whose genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence, based on the teachings of Cleary and Pearson (cited in the instant specification).
Instant claims 25 corresponds with limitations in claim 1 of the ‘299 patent. Instant claims 27 corresponds to claim 2. Instant claim 28 corresponds to claims 3-4. Instant claims 29-32, 35-43 correspond to claims 5-8, 11-20, of the ‘299 patent. Regarding new claims 45-48, it is noted that the specification indicates that it was known that 100 or more CAG repeats are known to be found in diseased subjects (see 1:50-60, citing Cleary and Pearson); that the uninterrupted CAG repeats are in a transcribed ATXN1 gene sequence, ATXN3 gene sequence, and HD gene sequence (e.g., see 6:57-67); the administration comprises intrathecal injection (see 10:33-47); and that the subject's cells can comprise ribonuclear foci associated with the repeat-expanded transcript, and whereby treating the subject reduces the formation or persistence of the ribonuclear foci (see 13:23-35 in descriptions of FIG. 9 and FIG. 10 as well as the figures themselves).
Claims 24-25, 27-32, 35-43, 45-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,345,915 (of record). Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a method of treatment as indicated above. The claims of the ‘915 patent are drawn to a method for treating, delaying, ameliorating and/or preventing a spinocerebellar ataxia (SCA), spinal and bulbar muscular atrophy (SBMA), or dentatorubral-pallidoluysian atrophy (DRPLA) in a subject, comprising providing to the subject an antisense oligonucleotide comprising a 2′-O-methyl RNA nucleotide residue, having a backbone wherein at least one phosphate moiety is replaced by a phosphorothioate moiety, and comprising a repetitive nucleotide unit (XYG)m, wherein m is an integer from 4 to 12 and each X is C or 5-methylcytosine, and each Y is U or 5-methyluracil, wherein at least one X is 5-methylcytosine, wherein said oligonucleotide is able to hybridize to a (CAG)n repetitive nucleotide unit (see claim 1). The instant claims have embodiments that are broader in scope (i.e., treating any genetic disorder associated with a human cis-element repeat instability, including SCA… ) with the exception of the requirement that the subject’s genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence. Accordingly, the broad embodiments claims are anticipated by the claims of the ‘915 patent. With respect to the requirement that the subject’s genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence, using the specification of the issued patent to define the scope and obvious variations of the claims, it is clear that the specification of the issued patent acknowledges that the diseased state has an increased number of repeat units, explicitly indicating 51 repeats can be found in the diseased state of a subject with HD (e.g., see 58:6-10). Furthermore, the prior art reference Cleary and Pearson, 2003 (cited in the other issued patent) also supports the position that it was well known in the art as well. Therefore, using the specification of the issued patent as a dictionary to define the scope of the claimed invention including obvious variations, it is clear that the broad claim encompasses treating a subject whose genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence. Furthermore, one of ordinary skill in the art would also have known that the claimed method of the patented invention could have been used to treat a subject whose genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence, based on the teachings of Cleary and Pearson.
Instant claim 27 corresponds to claim 19. Instant claim 28 requires a broad range in length of the oligonucleotide (10-50) which encompasses the oligonucleotides used in claim 10 (12-36) of the ‘915 patent. Instant claim 29 corresponds to claim 9. Instant claim 30 broadly requires that the oligonucleotide can comprise any of a number of different nucleotides including RNA nucleotides, which broadly encompasses the RNA oligonucleotide of claim 7 (e.g., SEQ ID NO: 90) of the ‘915 patent. Instant claims 31-32 correspond to limitations in claims 1, 24 of the ‘915 patent. Instant claims 35-37 correspond to limitations in claim 17 of the patent. Instant claim 38 corresponds to claim 18. Regarding claim 39 which requires that the oligonucleotide prevents the accumulation and/or translation of repeat expanded transcripts in cells, it is noted that the claimed method of the ‘915 patent would necessarily result in the oligonucleotide prevents the accumulation and/or translation of repeat expanded transcripts in cells. Similarly with respect to claim 41, the claim method of the ‘915 patent would necessarily result in the oligonucleotide interfering with gene expression or one or more other precursor RNA or messenger-RNA dependent cellular processes. Instant claim 40 corresponds to claim 20 of the ‘915 patent. Instant claims 42-43, 47 (parenteral/intrathecal administration) correspond to claims 22. 25 (also see 39:40-53) (intrathecal) of the ‘915 patent. Regarding new claims 45-46, it is noted that the specification indicates that it was known that 100 or more CAG repeats are known to be found in diseased subjects (see 14:7-34)); that the uninterrupted CAG repeats are in a transcribed ATXN1 gene sequence, ATXN3 gene sequence, and HD gene sequence (e.g., see 14:40-60).
Claims 24-25, 27-32, 35-43, 45-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8,263,760 (of record). Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are described in the rejections above. Claim 1 of the ‘706 patent is drawn to an oligonucleotide comprising an inosine, wherein said oligonucleotide consists of a sequence that is complementary to a repetitive sequence selected from the group consisting of (CAG)n, (GCG)n, (CUG)n, (CGG)n, (GAA)n, (GCC)n and (CCUG)n, and is 9 to 50 nucleotides long. Accordingly, the instant claimed method encompasses the use the claimed oligonucleotide of the ‘760 patent. Furthermore, although the claims of the issued patent do not indicate that that the diseased state can have 50, 100 or more repeats (such as in instant claim 45) the specification of the issued patent indicates that the diseased state can have 50, 100 or more repeats (e.g., see 1:37-44). Furthermore, the specification also provides for the limitations of instant claims 46-48 (e.g., see 9:50-60; 17:13-21; 2:5-22, 11:51-60).
The rejection is in view of the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates 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 and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
Claims 24-25, 27-32, 35-43, 45-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,745,576 (of record). Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a method of treating in a subject having a genetic disorder associated with a human cis-element repeat instability, wherein the subject’s genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence, the method comprising administering to the subject an oligonucleotide consisting of a sequence that is complementary only to a CAG repetitive sequence in a gene transcript (e.g., see claim 24). Claim 1 of the ‘576 patent is drawn to a 2′-O-methyl phosphorothioate oligoribonucleotide consisting of the base sequence (XYG)7, wherein each X is 5-methyl cytosine and each Y is uracil (SEQ ID NO: 2) or wherein each X is cytosine and each Y is 5-methyluracil (SEQ ID No:3). Accordingly, the instant claimed method encompasses the use the claimed oligonucleotide of the ‘576 patent.
The rejection is in view of the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates 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 and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
Furthermore, claims 5-6 of the ‘576 patent are drawn to a method for treating a subject having a human cis-element repeat instability associated genetic disorder by administering an oligoribonucleotide according to claim 2 to said subject. Although the claims of the issued patent does not indicate that the subject’s genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence, using the specification of the issued patent to define the scope and obvious variations of the claims, it is clear that the specification of the issued patent acknowledges that the diseased state has an increased number of repeat units, explicitly indicating 51 repeats can be found in the diseased state of a subject with HD (e.g., see 58:3-10). Furthermore, the prior art reference Cleary and Pearson, 2003 (cited in the other issued patent) also supports the position that it was well known in the art as well. Therefore, using the specification of the issued patent as a dictionary to define the scope of the claimed invention including obvious variations, it is clear that the broad claim encompasses treating a subject whose genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence. Furthermore, one of ordinary skill in the art would also have known that the claimed method of the patented invention could have been used to treat a subject whose genome comprises uninterrupted CAG repeats of at least 50 in a transcribed gene sequence, based on the teachings of Cleary and Pearson.
Regarding new claims 45-47, it is noted that it was well known in the prior art that 100 or more CAG repeats are known to be found in diseased subjects (e.g., Cleary and Pearson); that the uninterrupted CAG repeats are in a transcribed ATXN1 gene sequence, ATXN3 gene sequence, and HD gene sequence (e.g., see 36:23-45); the administration comprises intrathecal injection (see 39:37-40).
Response to Arguments
With respect to the rejection of claims under 35 USC 102, Applicant’s arguments have been fully considered and in view of the amendment to the claims, are persuasive. The rejection has been withdrawn.
With respect to the rejection non-statutory double patenting rejections, Applicant's arguments have been fully considered but they are not persuasive. For each of the rejections, Applicant presents the same argument: the amended claims now require subjects whose genome comprises “uninterrupted CAG repeats of at least 50 in a transcribed gene sequence” which is not taught or suggested by the claims of the issued patents. Applicant contends that a narrow species can be non-obvious and patent eligible despite a patent on its genus.
In response, as indicated in the rejections above, many of the patents explicitly teach in the specification that the genome of a diseased subject can have at least 50, 100 or more CAG repeats and furthermore, such was well known in the prior art as well, as acknowledged in the prior art reference (Cleary and Pearson) as indicated above. Thus, it is clear that the specification defines the claims of the issued patents as encompassing treating a subject whose genome has at least 50 or 100 CAG repeats in a transcribed gene sequence, and/or it would have been well known to one of ordinary skill in the art as acknowledged by Applicant’s citation of Cleary and Pearson. It is noted that the other new limitations, including the limitations of the new claims are addressed in the rejections above.
Therefore, Applicant’s arguments are not persuasive and the claims are rejected as indicated in the non-statutory double patenting rejections above.
It is noted that filing proper terminal disclaimers for each of the indicated issued patents cited in the rejections above would obviate the rejections and the claims would be allowable.
Conclusion
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637
