DETAILED ACTION
This Action is in response to the communication filed on 07/08/2026.
Claims 1, 8, 11-12. 21. 22. 25-37 are pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I and the species SEQ ID NO: 21 in the reply filed on 07/08/2026 is acknowledged.
Claims 12, 22, 25-34, 36-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/08/2026.
Claims 1, 8, 11, 21-22, and 35 are examined herein as they read on the elected subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 21- 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 is drawn to the antisense oligonucleotide of claim 1, or a pharmaceutically acceptable salt thereof where R1 is NR11R12 wherein each R11 and R12 are selected from hydrogen and C1-C6 alkyl. Claim 22 is drawn to the antisense oligonucleotide of claim 1, or a pharmaceutically acceptable salt thereof where R1 is -N-(Me)2. However, claim 1 defines R1 as being
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Therefore, R1 of claim 1 does not encompass NR11R12 wherein each R11 and R12 are selected from hydrogen and C1-C6 alkyl or N-(Me)2; accordingly claims 21-22 is outside of the scope of claim 1 and thus claim 22 does not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 1, 8, 11, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,066,228. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. The instant claims are drawn to an antisense oligonucleotide having a nucleobase sequence that comprises a nucleotide having the structure of the formula set forth in claim 1 wherein the nucleobase sequence is SEQ ID NO: 21 (the elected sequence). The claims of the ‘228 patent are drawn to an antisense oligonucleotide consisting of 10-40 nucleotides in length having a sequence complementary to an expanded DNA repeat which is associated with a human disease wherein each nucleotide has the structure of the formula set forth in claim 1 of the patent, which encompasses the structure of formula of instant claim 1. It is noted that claim 1 of the issued patent explicitly indicates that R1 must have at least one R1 of formula (I). The claims of the ‘228 patent do not explicitly require that the nucleotide sequence is SEQ ID NO: 21 as is required by the instant claims; however, using the specification of the ‘228 patent as a dictionary to define the scope and obvious variations of the claimed antisense oligonucleotide, it is clear that the specification of the ‘228 patented defines the antisense oligonucleotide of the claims as encompassing a nucleotide sequence that is instant SEQ ID NO: 21. For instance, see Brief Description of Figure 6 at column 8, lines 4-16 (8:4-16). Therefore, using the specification of the ’228 patent as a dictionary to define the scope of the issued claims, it is clear that the claimed antisense oligonucleotide of the ‘228 patent can have the sequence of SEQ ID NO: 21, which is explicitly required by instant claims 1 and 35.
Instant claim 8 corresponds with claim 8 of the ‘228 patent.
Instant claim 11 corresponds with claim 11 of the ‘228 patent.
Therefore, the instant claims are not patentable distinct from the claims of the issued patent and the instant rejection is appropriate.
Claims 1, 8, 11, 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,674,139. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to an antisense oligonucleotide having a nucleobase sequence that comprises a nucleotide having the structure of the formula set forth in claim 1 wherein the nucleobase sequence is SEQ ID NO: 21 (the elected sequence). The claims of the ‘139 patent are drawn to an antisense oligonucleotide of 10-40 nucleotides in length having a sequence complementary to an expanded DNA repeat which is associated with a human disease wherein each nucleotide has the structure of the formula set forth in claim 1 of the patent, wherein R1 is -N(Me)2, which similar to the structure of formula of instant claim 1 except for the R1 group. Furthermore, the claims of the ‘228 patent do not explicitly require that the nucleotide sequence is SEQ ID NO: 21 as is required by the instant claims. However, using the specification of the ‘139 patent as a dictionary to define the scope and obvious variations of the claimed antisense oligonucleotide, it is clear that the specification of the ‘129 patent defines the antisense oligonucleotide of the claims as having the structure of the formula of claim 1 where the R1 group can be -N(Me)2 or
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and the nucleotide sequence SEQ ID NO: 21 (for instance, see column 21:15-52, and Brief Description of Figure 6 at column 8:29-32). Therefore, using the specification of the ’129 patent as a dictionary to define the scope of the issued claims, it is clear that the claimed antisense oligonucleotide of the ‘228 patent can have the R1 group be N-(Me)2 (dimethylamine), and have the sequence of SEQ ID NO: 21, which is explicitly required by instant claims 1 and 35. Furthermore, although the claims of the ‘129 patent do not state that the oligonucleotide can be used to treat ALS, myotonic dystrophy type 1 or myotonic dystrophy type 2 (as required by claim 8) the specification of the ‘129 patent clearly indicates that the oligonucleotide can be used to treat ALS, myotonic dystrophy type 1 or myotonic dystrophy type 2 (for instance see 2:1-20, 27:1-15).
Instant claim 11 corresponds with claim 2 of the ‘129patent.
Therefore, the instant claims are not patentable distinct from the claims of the issued patent and the instant rejection is appropriate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/ Primary Examiner, Art Unit 1637
Prosecution Insights