DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to the communication filed 7-22-26.
Claims 1, 2, 6-14, 18-20, 37-48, 50-53 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I, the target gene combination of NaV1.7 & NaV1.8, and SEQ ID No. 201, claims 1, 2, 6-12, 14-24, 18-20, 37-48, 50-53 in the reply filed on 7-22-26, is acknowledged.
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species or invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7-22-26.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because 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 - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
PLEASE PROVIDE THE SEQUENCES AND POSITIONS OF MODIFICATIONS OF THE MOLECULES LISTED IN FIGS. 5-19, ALONG WITH ACCOMPANYING SEQ ID NOS.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
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) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 9, 10, 12-14, 18, 37-40, 45, 48, 50, 53 are rejected because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to products of nature without significantly more. The claim(s) recite(s) products of nature including EsaA. This judicial exception is not integrated into a practical application because they recite products of nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they recite compositions comprising products of nature. The claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to non-statutory subject matter.
The claimed invention is directed to products of nature comprising nucleic acid fragments. The claims do not include any elements that add significantly more to any judicial exceptions, and do not include features that demonstrate that the recited products are markedly different from what exists in nature. The fragments perform in their natural way, serve the ends nature originally provided, and act quite independently of any effort of patentee. There are no marked differences in the function or structure of these naturally occurring molecules, and their characteristics do not change from that occurring in nature.
In sum when the relevant factors are analyzed, they weigh toward ineligibility under 35 U.S.C. 101. Therefore, the claims are non-statutory, and the rejection under 35 U.S.C. 101 is appropriate.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 6-14, 18-20, 37-48, 50-53 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 9, 10, 37, 45, 53 recite “about” and/or “at least about.” The metes and bounds of these terms cannot be determined. Appropriate clarification is required.
Claims 12 and 48 recite “wherein the oligonucleotide has a base sequence that
has been screened and determined to not meet a threshold match for any non-target transcripts in humans”.
The phrase “a threshold match for any non-target transcripts in humans” is vague and unclear. The metes and bounds of this phrase cannot be determined. Appropriate correction is required.
Claim 13.recites “wherein the oligonucleotide has a base sequence with 0 mismatches to a homologous segment in a non-human primate genome and no more than about 5 mismatches in a homologous segment in a rodent genome”
It is unclear what “a homologous segment in a rodent genome” encompasses. The metes and bounds cannot be determined. Appropriate clarification is required.
In claim 47, last line, it is unclear what “balance PO” what stands for or represents. Appropriate correction or clarification is required.
Claim 50 recites that “the DRG neurons exhibit a dose dependent knockdown of NaV1.7 and 1.8” upon delivery of the oligonucleotide composition to the dorsal root ganglion (DRG) neurons in vitro.
It is unclear what defines “a dose dependent knockdown”.
Claim Rejections - 35 USC § 112
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.
Claims 1, 2, 6-14, 18-20, 37-48, 50, 51, 53 are 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.
The specification fails to provide the requisite guidance for using the genus of therapeutic agents instantly claimed, and further whereby treatment is provided in any subject.
The breadth of the claims:
The claims are drawn to compositions for treating pain comprising an oligonucleotide that hybridizes to an RNA encoding a sodium channel protein along a segment of the RNA that is at least about 75, 89, or 94 % complementary to one of SEQ ID NOs: 166-390, which oligonucleotide optionally comprises two wings flanking a central region of at least 10 DNA bases, and at least one end of the oligonucleotide comprises modified RNA bases selected from 2'-O-methoxyethyl RNA and 2'-O-methyl RNA, which oligonucleotide optionally comprises between about 15 to about 25 bases, and optionally has a backbone comprising a plurality of phosphorothioate bonds.
Teachings in the specification:
Table 1 has SEQ ID NOS. 1-386, showing 100% homology to SCN9a and/or SCN10 or single mismatches thereof.
FIG. 3 shows a 2'-O-Methoxyethyl ("2'-MOE") modified sugar that may be included in an RNA base.
FIG. 4 shows a phosphorothioate bond 505 within the backbone of a segment of DNA, such as the central region 221 of the oligonucleotide 207. The oligonucleotide 207 may include one or any number of the phosphorothioate bonds 505. For example, every backbone linkage within the oligonucleotide 207 may be phosphorothioate, or most, or about half may be one or any number of the phosphorothioate bonds 505. For example, every backbone linkage within the oligonucleotide 207 may be phosphorothioate, or most, or about half may be.
FIG. 6 shows NaV1.7-targeting ASOs effect on mRNA expression at DIV14 in rat DRG neurons compared to a control. It is noted that a composition 101 of the disclosure may include a plurality of copies of a plurality of distinct therapeutic gapmers of one of the preceding claims in a carrier formulated for intrathecal administration. Preferably, any one or more of the oligonucleotides 107 exhibits at least 25% better NaV knockdown than a control gapmer in an assay using DRGs in vitro, where the candidate oligonucleotides and the controls are linked mostly or only by phosphorothioate linkages and include a central segment of DNA bases flanked by a 5' wing of 2'-MOE RNA bases and 3' wing of 2'-MOE RNA bases.
FIG. 7 shows the selectivity of rat NaV-targeted ASOs tested by qPCR in rat DRG. The top panel shows the effect on mRNA levels of delivery an ASO specific for NaV1.7. The middle panel shows the effect of delivering an ASO specific for NaV1.8; the bottom panel is for NaV1.9. In all panels, the fourth triad of bars gives the results for delivering a 450 nM cocktail ASO (150 nM NaV1.7 ASO + 150 nM NaV1.8 ASO + 150 nM NaV1.9 ASO). In each panel, the non-target NaV channel was not knocked down by the ASO (Nav1.7 ASO did not knock down expression of NaV1.8 or NaV 1.9, etc., showing target selectivity). The cocktail of 3 oligonucleotides 107 is shown to knock down all the three targets.
FIG. 8 compares the effects of ribose sugar modification within oligonucleotides 107 of the disclosure. An oligonucleotide 107 with a 20 base sequence matching the 20 bases beginning at position 1294 of the human SCN9A gene (SEQ ID NO: 6) was tested in a form with 2'-0- methyl- (OMe) and in a form with 2'-O-Methoxyethyl- (MOE) ribose sugar modifications.
FIG. 9 shows a measured level of neural activity in response to an increasing ramp of blue light stimulation at a baseline, under treatment with the irritant, and under treatment with the irritant and an anti-NaV1.7 ASO. As expected, the NaV1.7 ASO decreases the neural excitability exhibited in response to the irritant.
FIG. 10 shows a measured level of neural activity in response to an increasing ramp of blue light stimulation at a baseline, under treatment with the irritant, and under treatment with the irritant and an anti-NaV1.8 ASO. As expected, the NaV1.8 ASO decreases the neural excitability exhibited in response to the irritant, albeit in a different region of the input stimulus power.
FIG. 11 shows a measured level of neural activity in response to an increasing ramp of blue light stimulation at a baseline, under treatment with the irritant, and under treatment with the irritant and a composition comprising an anti-NaV1.7 ASO and an anti-NaV1.8 ASO. The net pain reducing effect of the combination of oligos is better than either oligo alone. The level of activity the DRG neurons is significantly lower across the full range of input stimulation.
FIG. 12 shows that ASOs of the disclosure provide potent and selective knockdown of multiple Nav targets. In the figure, the top graph shows comparative expression levels of NaV1.7 beside NaV1.5 and NaV1.2, when treated with four different ASOs (labelled ASO1, ASO2, ASO3, and ASO4) at 2 concentrations. The bottom graph shows comparative expression levels of NaV1.8 beside NaV1.5 and NaV1.2, when treated with those same four different ASOs (again, ASO1, ASO2, ASO3, and ASO4) at 2 concentrations.
The specification also teaches the following:
The human Nav1.7/Nav1.8 dual knockdown sequences exemplified by SEQ ID NOs: 142-164 are each preferably provided as a 19-mer ASO gapmer design following a 5x9x5 configuration, with 9-base DNA core with 5' and 3' RNA-like wings. Preferably, the 5' and 3' wings at least substantially follow 2-methoxyethyl (2'-MOE) chemistry and the backbone linkages include a mixture of phosphorothioate (PS) and phosphodiester (PO) (e.g., outer-most inter-base linkages and all linkages involving a DNA base are PS, and in which the other three inter-RNA linkages of each wing comprise either two or three PS linkages, balance PO). In certain embodiments, the human Nav1.7/Nav1.8 dual knockdown comprises an oligonucleotide with a sequence as given by one of SEQ ID NOs: 142-164 and a gapmer composition as just described.
All the group 1 dual knockdown ASOs have 100% match with human SCN9A transcript and only have 1 nucleotide mismatch with human SCN10A. The indicated dual-knockdown ASO oligonucleotides of group 1 have a 5-9-5 gapmer design, with a 9-base DNA core and 5' and 3' RNA-like wings. The 5' and 3' wings include 2-methoxyethyl (2'-MOE) chemistry. The backbone includes a mixture of phosphorothioate (PS) and phosphodiester (PO), e.g., in which the second, third, fourth, fifteenth, and seventeenth linkages (in the direction written in the sequences) may be PO, with all others being PS. Preferably any of SEQ ID Nos: 142-152 have that backbone chemistry. Each of the sequences in this group 1 has zero mismatches to a target sequence in human SCN9A pre-RNA or mRNA and 1 mismatch to a target sequence in human SCN10A pre-RNA or mRNA.
Of the dual knockdown sequences, a second preferred embodiment is dubbed group 2, illustrated by SEQ ID NOs: 153-164, also described as Ref. No. (Target code/ No.) 5/49-5/60. All the group 2 dual knockdown ASOs have 100% match with human SCN10A transcript and only have 1 nucleotide mismatch with human SCN9A. The indicated dual-knockdown ASO oligonucleotides of group 2 have a 5-9-5 gapmer design, with 9-base DNA core with 5' and 3' RNA-like wings. The 5' and 3' wings include 2-methoxyethyl (2'-MOE) chemistry. The backbone includes the mixture of phosphorothioate (PS) and phosphodiester (PO), e.g., in which the second, third, fourth, fifteenth, and seventeenth linkages (in the direction written in the sequences) may be PO, with all others being PS. Preferably any of SEQ ID NOs. 153-164 have that backbone chemistry. Each of the sequences in this group 2 has 1 mismatch to a target sequence in human SCN9A pre-RNA or mRNA and zero mismatches to a target sequence in human SCN10A pre-RNA or mRNA.
FIG. 12 shows that ASOs of the disclosure provide potent and selective knockdown of multiple Nav targets. In the figure, the top graph shows comparative expression levels of NaV1.7 beside NaV1.5 and NaV1.2, when treated with four different ASOs (labelled ASO1, ASO2, ASO3, and ASO4) at 2 concentrations. The bottom graph shows comparative expression levels of NaV1.8 beside NaV1.5 and NaV1.2, when treated with those same four different ASOs (again, ASO1, ASO2, ASO3, and ASO4) at 2 concentrations.
[Emphases added}{citations omitted].
The specification fails to provide the requisite guidance for making and using the genus of therapeutic agents instantly claimed, and further whereby treatment is provided in any subject. Since the disclosure fails to describe the common attributes and characteristics concisely identifying members of the proposed genus of therapeutic agents, and because the claimed genus is highly variant, the description provided is insufficient. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the broad genus of therapeutic agents instantly claimed and further whereby therapeutic effects are provided in a subject.
Thus, Applicant was not in possession of the broadly claimed genus.
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.
Claim(s) 1, 2, 9, 10, 12, 13, 18, 48, 53 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Dharmacon, Inc. (US 2007/0031844).
Dharmacon, Inc. (US 2007/0031844) teach compositions comprising an oligonucleotide sharing at least 75% complementarity with SEQ ID No. 201. (see the alignment below with Sequence 448713 of Dharmacon).
Align w seq id no. 201
RESULT 1
US-10-714-333A-448713/c
(NOTE: this sequence has 7 duplicates in the database searched.
See complete list at the end of this report)
Sequence 448713, US/10714333A
Publication No. US20070031844A1
GENERAL INFORMATION
APPLICANT: Dharmacon, Inc.
APPLICANT: Khvorova, Anastasia
APPLICANT: Reynolds, Angela
APPLICANT: Leake, Devin
APPLICANT: Marshall, William
APPLICANT: Scaringe, Stephen
TITLE OF INVENTION: Functional and Hyperfunctional siRNA
FILE REFERENCE: 13499US
CURRENT APPLICATION NUMBER: US/10/714,333A
CURRENT FILING DATE: 2003-11-14
PRIOR APPLICATION NUMBER: 60/502,050
PRIOR FILING DATE: 2003-09-10
PRIOR APPLICATION NUMBER: 60/426,137
PRIOR FILING DATE: 2002-11-14
NUMBER OF SEQ ID NOS: 1591911
SEQ ID NO 448713
LENGTH: 19
TYPE: DNA
ORGANISM: Homo sapiens
Query Match 100.0%; Score 19; Length 19;
Best Local Similarity 100.0%;
Matches 19; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TGTTTGCCTGGTTCTGTTC 19
|||||||||||||||||||
Db 19 TGTTTGCCTGGTTCTGTTC 1
Claim(s) 1, 2, 7-10-14, 18-20, 37-40, 43-48, 53 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by CRISPR THERAPEUTICS AG (US 2019/0153477).
CRISPR THERAPEUTICS AG (US 2019/0153477) teach compositions comprising an oligonucleotide sharing at least 75% complementarity with SEQ ID No. 201, and further comprising one or more phosphorothioate internucleotides, 5’-methyl bases, and/or 2’O-methyl sugar modifications, etc. (see esp. para. 0155-0166, and the alignment below with SEQ 109254 of Crispr Therapeutics AG.
Align w seq id no. 201
RESULT 7
US-16-315-547-109254
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 109254, US/16315547
Publication No. US20190153477A1
GENERAL INFORMATION
APPLICANT: CRISPR THERAPEUTICS AG
TITLE OF INVENTION: MATERIALS AND METHODS FOR TREATMENT OF PAIN RELATED
TITLE OF INVENTION: DISORDERS
FILE REFERENCE: C1542.70022US02
CURRENT APPLICATION NUMBER: US/16/315,547
CURRENT FILING DATE: 2019-01-04
PRIOR APPLICATION NUMBER: PCT/IB2017/054086
PRIOR FILING DATE: 2017-07-06
PRIOR APPLICATION NUMBER: US 62/461,874
PRIOR FILING DATE: 2017-02-22
PRIOR APPLICATION NUMBER: US 62/358,763
PRIOR FILING DATE: 2016-07-06
NUMBER OF SEQ ID NOS: 125503
SEQ ID NO 109254
LENGTH: 20
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Description of Artificial Sequence: Synthetic
oligonucleotide
FEATURE:
OTHER INFORMATION: Target: SCN9A; (+) strand; PAM type: YTN;
PAM sequence: TTC
Query Match 94.7%; Score 18; Length 20;
Best Local Similarity 100.0%;
Matches 18; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TGTTTGCCTGGTTCTGTT 18
||||||||||||||||||
Db 3 TGTTTGCCTGGTTCTGTT 20
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.
Claims1, 2, 6-12, 14-24, 18-20, 37-48, 50- are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 14-16 of copending Application No. 19/210,973 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions for treating pain comprising an oligonucleotide that hybridizes to an RNA encoding a sodium channel protein along a segment of the RNA that is at least about 75, 89, or 94 % complementary to one of SEQ ID NOs: 166-390, which oligonucleotide optionally comprises two wings flanking a central region of at least 10 DNA bases, and at least one end of the oligonucleotide comprises modified RNA bases selected from 2'-O-methoxyethyl RNA and 2'-O-methyl RNA, which oligonucleotide optionally comprises between about 15 to about 25 bases, and optionally has a backbone comprising a plurality of phosphorothioate bonds.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Certain papers related to this application may be submitted to Art Unit 1637 by facsimile transmission. The faxing of such papers must conform with the notices published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 C.F.R. ' 1.6(d)). The official fax telephone number for the Group is 571-273-8300. NOTE: If Applicant does submit a paper by fax, the original signed copy should be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jane Zara whose telephone number is (571) 272-0765. The examiner’s office hours are generally Monday-Friday, 10:30am - 7pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Dunston, can be reached on (571)-272-2916. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (703) 308-0196.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Jane Zara
9-8-26
/JANE J ZARA/Primary Examiner, Art Unit 1637
Prosecution Insights