DETAILED ACTION
This Action is in response to the communication filed on 12/02/2025.
Claims 1-2, 4-33 are pending.
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 .
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)(251) 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 it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also 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.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). For instance, see pages 69-70, Table 3, Table 7, Table 10, Table 12, Table 14, Table 15, Table 17, Table 18, Table 19. It is noted that this list is not meant to be exhaustive and Applicant is asked to review the entire disclosure for other sequences as bringing the application into compliance with the sequence rules in response to this office action is required.
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 sequence identifiers, 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.
Election/Restrictions
Applicant's election with traverse of Group I and the indicated species in the reply filed on 12/02/2025 is acknowledged. The traversal is on the ground(s) that there would not be a serious search burden as there would be substantial overlap in searching the each of the two groups and the two groups are both in the same class. This is not found persuasive because although the two groups have the same class they have different subclassifications (C12N15/111 and C12N15/113), which is prima facie evidence of a serious search burden as a search of the different classifications would be required for each group. Furthermore there would be different considerations when examining Group II, for instance, with respect to question of enablement for the claimed method of Group II. Therefore, Applicant’s arguments are not persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 26-30, 32-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species (26-30) or invention (32-33) as acknowledged by Applicant in the 12/02/2025 response (e.g., see claims amendment which identifies the withdrawn claims), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/02/2025.
Claims 1-2, 4-25, 31 are under consideration.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-7, 9-10, 12-20, 22-23, 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 2015/0211006 (hereafter “Butler”).
Regarding claim 1, Butler teaches a chirally-modified dsRNA with strands in the range of 14 to 40 nucleotides in length, wherein a chiral modification occurs at the first internucleotide linkage at the 5' end of the antisense strand, and the chiral linkage phosphorus atom is in Rp configuration, and a chiral modification occurs at the first internucleotide linkage at the 3' end of the antisense strand and the chiral linkage phosphorus atom is in Sp configuration. For instance, see PCSK9(17) on page 270 which has an antisense strand with an Rp linkage at the 5’ terminal internucleotide linkage and an Sp linkage at the 3’ terminal internucleotide linkage as well as the complementary sense strands in the table after paragraph [1995].
Therefore, Butler anticipates claim 1.
Regarding claim 2, Butler teaches that the chiral purity with respect to the chiral linkage phosphorus atom of each internucleotide linkage can be at least or greater than 50% (e.g., see [0611] which indicates that the compositions can be about 50% up to about 99.9% diastereomerically pure.
Regarding claims 4, 9, 14-15 all internucleotide linkages of the antisense strand of PCSK9(17) comprise a chiral linkage phosphorus atom (see page 270).
Regarding claims 5- 6, Butler teaches PCSK9(17) which has an Rp linkage at the 5’-end and an Rp linkage as the second to last linkage at the 3’-end, and an Sp linkage as the last linkage at the 3’-end of the antisense strand (see page 270). It is noted that in claim 5 the phrase “having the linkage phosphorus atom in Sp configuration” only requires one of the two internucleotide linkages at the 3’-end of the antisense strand to be in the Sp configuration.
Regarding claim 7, Butler teaches PCSK(17) which is a dsRNA wherein the antisense strand having a chiral modification at the first internucleoside linkage at the 3’ end in the Sp configuration and the first and second internucleoside linkage at the 5’ end also comprise chirally modified linkages including one having the linkage phosphorus atom in Rp configuration (see page 270). It is noted the phrase “having the linkage phosphorus atom in Rp configuration” only requires one of the two internucleotide linkages needs to be in the Rp configuration.
Regarding claim 10, Butler teaches PCSK(17) which is a dsRNA wherein the antisense strand having a chiral modification at the first, second and third internucleoside linkage at the 3’ end (i.e., the last three linkage of the AS strand) including one having the linkage phosphorus atom in the Sp configuration, and the first internucleoside linkage at the 5’ end also comprises a chirally modified linkage in Rp configuration (see page 270). It is noted the phrase “having the linkage phosphorus atom in Sp configuration” only requires one of the three internucleotide linkages needs to be in the Sp configuration.
Regarding claim 12, Butler teaches PCSK(17) which is a dsRNA wherein the antisense strand has (i) a chiral modification at the first internucleoside linkage at the 3’ end is in Sp configuration, (ii) the first and second internucleoside linkages at the 3’ end have the linkage phosphorus atom in Rp configuration, and (iii) the first internucleoside linkage at the 5’ end also comprises a chirally modified linkage in Rp configuration (see page 270). It is noted the phrase “having the linkage phosphorus atom in Rp configuration” only requires one of the two internucleotide linkages needs to be in the Rp configuration – which is clear because (i) requires the first internucleoside linkage at the 3’ end is in Sp configuration, thus the only way that the properly interpret (ii) in light of (i) is that one of the two indicated linkages needs to be in Rp configuration because the first linkage must be in Sp configuration, as required by (i).
Regarding claim 13, Butler teaches PCSK(17) which is a dsRNA wherein the antisense strand has the first two linkages at the 3’ end have at least one linkage in the Sp configuration and the first two linkages at the 5’ end have at least one linkage in the Rp configuration (see page 270). It is noted that “having the linkage phosphorus atom in Rp configuration” only requires one of the two internucleotide linkages needs to be in the Rp configuration, and “having the linkage phosphorus atom in Sp configuration” only requires one of the two internucleotide linkages needs to be in the Sp configuration.
Regarding claim 16, Butler teaches PCSK9(31) which is a dsRNA with chiral linkages at the 5’-end (Rp) and 3’-end (Sp) of the antisense strand as indicated on page 271, wherein each of the nucleotides on either side of the terminal chiral linkages are modified with either 3’-O-methyl, 2’-fluoro (2’-F), or 2’deoxy modifications (see page 271).
Regarding claim 17, Butler teaches dsRNA comprising a sense strand (see PCSK9 (19)-(24)) and complementary antisense strand (see PCSK9 (25)-(32)) modified with a modification including a 2’O-methyl, 2’-fluro (2’-F), of 2’-deoxy modification (see pages 270-271).
Regarding claims 18-19, Butler teaches PCSK9(17) which is a dsRNA wherein each of the strands is within the range of 15-30 nucleotide including a sense strand having 19-22 nucleotides and an antisense strand having 19-25 nucleotides (see the sense strands in the table after paragraph [1995] and antisense strand PCSK9 (17) on page 270).
Regarding claim 20, Butler teaches that the siRNA molecules can comprise a ligand (e.g., see [1408]).
Regarding claim 22, Butler teaches that the oligonucleotide can be conjugated to a ligand and can be coupled with a biodegradable (i.e., cleavable) linker (see [1260]).
Regarding claim 23, Butler teaches that the ligand can be an ASGPR-ligand (e.g., see [1408]).
Regarding claim 31, Butler teaches pharmaceutical compositions comprising the disclosed chirally controlled oligonucleotide and a pharmaceutically acceptable carrier (e.g., see [0041], [1404], claim 64, etc.).
Claims 1, 2, 4-9, 13, 16-25, 31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2018035380 (hereafter “Sakamuri”).
Regarding claim 1, Sakamuri teaches a chirally-modified dsRNA agent comprising strands having 14 to 40 nucleotides, wherein: the antisense strand comprises a chirally-modified internucleotide linkages at the 5' end and one or more terminal, chirally-modified internucleotide linkages at the 3' end; wherein the chirally-modified internucleotide linkage comprises a chiral linkage phosphorus atom, and the terminal chiral modification occurs at the first internucleotide linkage at the 5' end of the antisense strand and the chiral linkage phosphorus atom is in Rp configuration; and a terminal, chiral modification occurs at the first internucleotide linkage at the 3' end of the antisense strand, and the chiral linkage phosphorus atom is in Sp configuration. For instance, see Table 4 compound Z224 on page 145 which comprises a guide strand (i.e., antisense strand) having two chirally modified internucleotide linkages at the 5’ end that are both in Rp configuration and two internucleotide linkages at the 3’ end that are both in Sp configuration.
Regarding claim 2, Sakamuri teaches that the diastereomeric ratio for the phosphorothioate of the predetermined stereochemistry may be greater than or equal to 1.1 (e.g., see page 28, lines 10-12), thus the chiral purity is greater than 50%.
Regarding claim 4, Sakamuri teaches the dsRNA comprises three or more terminal chirally modified internucleotide linkages at the antisense strand (e.g., see page 145, compound Z224 which has four chirally modified internucleotide linkages at the antisense strand).
Regarding claim 5 Sakamuri teaches compound Z231 on page 145 which has an antisense strand with a 5’-terminal end internucleotide linkage in the Rp configuration and the last two internucleotide linkages at the 3’-terminal end are in the Rp and Sp configurations, respectively.
Regarding claim 6 Sakamuri teaches compound Z224 on page 145 which has an antisense strand with a 5’-terminal end internucleotide linkage in the Rp configuration and the last two internucleotide linkages at the 3’-terminal end are in the Sp configuration.
Regarding claim 7 Sakamuri teaches compound Z231 on page 145 which has an antisense strand with the two 5’-terminal end internucleotide linkages in the Rp configuration and the last internucleotide linkages at the 3’-terminal in the Sp configurations.
Regarding claim 9, Sakamuri teaches compound Z224 which has four terminal chirally modified internucleotide linkages at the antisense strand (two at each end).
Regarding claim 13, Sakamuri teaches compound Z224 which has an antisense strand with the two 5’-terminal end internucleotide linkages in the Rp configuration and the last two internucleotide linkages at the 3’-terminal are in the Sp configurations.
Regarding claims 16-17, Sakamuri teaches compound Z224 which two modified nucleotides linked by the chirally modified internucleotide linkages (nucleotide 1 and 2 from the 5’ or 3’ ends) wherein the modified nucleotides are 2’-O-methyl (also known as 2’-methoxy) or 2’-fluoro modified nucleotides as represented by upper or lower case letters in Z224.
Regarding claims 18-19, Sakamuri teaches Z224 which has a sense strand in the range of 10-22 nucleotides and the antisense strand in the range of 19-25 nucleotides.
Regarding claims 20-25 Sakamuri teaches Z224 which has a sense strand coupled with NAG26 (an ASGPR ligand) at the 3’ end via a cleavable X2 linker wherein the X2 linker is a trivalent linker (e.g., see Fig. 8B), and Sakamuri further teaches that the ASPGR ligand can be a GalNAc derivative that has the structure indicated in claim 25 (e.g., see page 96).
Regarding claim 31, Sakamuri teaches pharmaceutical compositions comprising the disclosed chirally controlled oligonucleotide and a pharmaceutically acceptable carrier or excipient (e.g., see under “Pharmaceutical Compositions” beginning on page 56).
Therefore, Sakamuri anticipates the instant claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 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.
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2015/0211006 (hereafter “Butler”).
As indicated above, Butler teaches chirally-modified dsRNA agents with strands in the range of 14 to 40 nucleotides in length, wherein a chiral modification occurs at the first internucleotide linkage at the 5' end of the antisense strand, and the chiral linkage phosphorus atom is in Rp configuration, and a chiral modification occurs at the first internucleotide linkage at the 3' end of the antisense strand and the chiral linkage phosphorus atom is in Sp configuration. For instance, PCSK9(17) and complementary strands, which include chirally-modified internucleotide linkages throughout the dsRNA agent, such as on pages 269-270.
Although Butler teaches a dsRNA agent with a linkage in the Sp configuration at one of the last two linkages at the 3’ end of the antisense strand, as well as a linkage in the Rp configuration at the 5’ end of the antisense strand (such as in PCSK9(17)), Butler does not teach that said dsRNA also comprises an Rp at the third to last internucleotide linkage at the 3’end of the antisense strand of the dsRNA, as required by claim 11.
However, Butler teaches dsRNAs with chirally-modified internucleotide linkages at every linkage in each strand of the dsRNA, including dsRNAs that have an antisense strand with a chirally-modified linkage at the 5’ terminal linkage in the Rp configuration (see PCSK9(17) as well as the other nucleotide sequences on pages 269-271), an antisense strand with a chirally-modified linkage at the 5’ terminal linkage in the Sp configuration (e.g., see PCKS9(17)), an antisense strand with a chirally-modified linkage at the second to last linkage at the 3’ terminal end in the Rp configuration (see PCKS9(17)), an antisense strand with a chirally-modified linkage at the second to last linkage at the 3’ terminal end in the Sp configuration (see PCKS9(18) on page 270), and an antisense strand with a chirally-modified linkage at the third to last linkage at the 3’ terminal end in the Rp configuration (see PCKS9(18)). Therefore, Butler teaches two different siRNA agents, specifically PCSK9(17) and PCSK9(18), that between them have the specifically required chirally modified internucleotide linkages (Rp or Sp) at the specifically required internucleotide linkages on the antisense strand.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art to make a dsRNA agent that meets the structural limitations of claim 11 having a terminal, chiral modification occurring at the first and second internucleotide linkages at the 3' end of the antisense strand, having the linkage phosphorus atom in Sp configuration, a terminal, chiral modification occurring at the third internucleotide linkages at the 3' end of the antisense strand, having the linkage phosphorus atom in Rp configuration, and a terminal, chiral modification occurring at the first internucleotide linkage at the 5' end of the antisense strand, having the linkage phosphorus atom in Rp configuration, with a reasonable expectation of success. To make a dsRNA encompassed by claim 11, only a single change needs to be made to either PCSK9(17) or PCSK9(18). Specifically for PCSK9(17), only the third internucleotide linkage from the 3’ end needs to be changed from Sp to Rp; and for PCSK9(18), only the first internucleotide linkage at the 5’ end needs to be changed from Sp to Rp.
It is noted that KSR forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http://www.uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
It is noted that KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 USPQ2d 1385 (2007) states:
“Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.”
In this case, modifying the chirally modified antisense strands of the dsRNA taught by Butler to arrive at the claimed dsRNA would have been a matter of simple substitution of one known element for another to obtain predictable results, and/or “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. One of ordinary skill in the art would have wanted to make the required change in order to test different combinations of chirally modified linkages in order to test them to identify the combination that gave the best results.
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 1-2, 4-25, 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5-24 of U.S. Patent No. 11597932. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader in scope than the claims of the ‘932 patent, therefore, the instant claims are anticipated by the claims of the ‘932 patent.
Instant claim 1 is similar to claim 1 of the ‘932 patent, but does not include the limitation that the sense strand comprises one or more terminal, chirally-modified internucleotide linkages at the 5′ end. Therefore, instant claim 1 is broader in scope that claim 1 of the’932 patent. It is noted that instant claims 2, 4-25, 31 are all dependent claims and correspond with dependent claims 2, 5, 7, 11-22 of the ‘932 patent.
Therefore, a non-statutory double patenting rejection of the instant claims over the claims of the ‘932 patent is appropriate.
Conclusion
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637