DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of group IV (Claims 18-20) in the reply filed on 7/11/25 is acknowledged. An election of species is missing as required on page 5 of the restriction mailed on 4/11/25. However, upon further consideration, the species requirement for SEQ ID NOs: 1, 2, and 103 is withdrawn.
No claims are withdrawn at this time since the amendment filed on 7/11/25 cancelled all of the claims directed to non-elected inventions.
The amendment to the specification filed on 9/20/22 has been entered.
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 – 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. Figures 3B, 3C 3F
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
Drawings
The drawings were received on 9/20/22. These drawings are acceptable.
Specification
The use of the term COSENTYX, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. See page 14.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Due to the limited the examiner has to review the specification for trademark issue, the examiner kindly request that the application please review the entire specification for any additional trademark issues.
Table 2 on page 23 is labelled as REMSA probes, but page 26 indicates that it is sequence for SBE aptamers. Clarification is requested as to what table lists the SBE WT aptamer or SBE mutant C aptamer.
The disclosure is objected to because of the following informalities: Supple Fig 6B on page 39. Is there a supplemental figure labelled Fig 6B?
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 18 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product found in nature without significantly more. The claims recite a composition comprising a nucleic acid sequence comprising a SBD nucleic acid that binds a SEFIR domain of an ACT1 protein, wherein the nucleic acid sequence comprises a sequence selected from SEQ ID NOs: 1, 2 (Qy) or 103 and is not naturally occurring. SEQ ID NO: 1 is a 17-mer and SEQ ID NO 2 and 103 are an 11-mer with variables (SEQ ID NOs: 1 and 3, N is A, C, G, T, or SEQ ID NO: 103, N is A or U) at several nucleotides. The claimed is directed to a composition of matter which is a statutory subject matter. This judicial exception is not integrated into a practical application because the broadest reasonable interpretation (BRI) of the structural limitation of the product reads on a nucleic acid found in nature. SEQ ID NO: 1296987 (Db) in Bentwich U.S. Patent No. 7655785 is directed to a microRNA isolated from nature.
Qy 1 AAGANNNUCUU 11
Db 1 AAGAUCCUCUU 11
SEQ ID NO: 27 (Db) in U.S. Patent No. 11352630 is a SNP found in a human TRPC6 gene (column 48).
Qy 1 AAGANNNUCUU 11
Db 1 AAGATCCTCTT 11
The term “SBE nucleic acid” does not change the structure of the nucleic acid from a nucleic acid comprising any of the sequences. Page 3 discloses that the SBE nucleic acid is from a gene selected from CXCL1, GM-CSF, IL-6 and TNF. These genes are found in nature in a human. The limitation ‘which is not naturally occurring’ does not have patentable weight because it does not change the structure of the nucleic acid. The BRI of the limitation reads on the nucleic acid not being found in nature or synthetically produced in a lab or ordered and produced by a biotechnology company. For example, SEQ ID NO: 2 reads on a microRNA, a murine chemokine ligand 1 mRNA or a SNP sequence found in nature, but these products could be excluded from reading on the claimed product. However, if one of skill in the art made the sequence or ordered from a company then it would read on the claimed product because it was synthetically produced and isolated from a product found in nature. In addition, a product of nature exception includes both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See MPEP2106.04(b)(II) Products of Nature. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because placing the nucleic acid in a composition does not change the structure of the nucleic acid. When the claims are compared to a nucleic acid found in nature, the comparison indicates that there are no differences in structure, function or other characteristics. With respect to any function or characteristic (binds a SEFIR domain of an ACT1 protein), the products found in the prior art have the same sequence. Thus, any function or characteristic not disclosed in the prior art would be considered an inherent property of the nucleic acid. Therefore, the claimed nucleic acid is a product of nature exception. The composition in the claims does not impose any limits on the composition. Because a nucleic acid must be placed into a container in order to store it and use it, merely reciting a generic “composition” thus fails to meaningfully limit the claim because it is at best the equivalent of merely adding the words “apply it” to the judicial exception. The limitation ‘wherein the nucleic acid is present in said composition in an amount that is therapeutic when administered to a subject with an IL-17a related disease or disorder’ in the dependent claim 20 is directed to an intended use. In addition, the specification does not appear to provide a definition for the term ‘level that that is therapeutic for treating IL-17a related disease or condition’. In view of the broadest reasonable interpretation of the limitation, the claimed embraces any amount of the nucleic acid.
Thus, claims 18 and 20 are not patent eligible.
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.
Claims 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rigoustsos et al. (US 20110178283).
‘283 teaches a composition comprising a nucleotide sequence that comprises SEQ ID NO: 574534 (Db) or RNA transcripts corresponding to the sequence, which would read on a nucleotide sequence comprising instant SEQ ID NO: 2 (abstract and pages 1 and 12-13).
Qy 1 NGNUAAUANCN11; SEQ ID NO: 2, wherein N is A, C, G, T or U;
Db 3 TGATAATAACT 13
The BRI of the claimed product embraces a composition comprising a synthetic sequence shown in SEQ ID NOs: 1, 2, or 103. SEQ ID NO: 1 is a 17-mer and SEQ ID NO 2 and 103 are an 11-mer with variables (SEQ ID NOs: 1 and 3, N is A, C, G, T, or SEQ ID NO: 103, N is A or U) at several nucleotides. The claims are not limited in particular length and any sequence comprising any one of these sequences with the defines variables would read on the claimed product. In addition, the claims are not limited to a single stranded sequence and can read on a double stranded sequence comprising SEQ ID NO: 1. The term “SBE nucleic acid” recited in claim 18 does not change the structure of the nucleic acid from a nucleic acid comprising any of the sequences. The limitation ‘which is not naturally occurring’ does not have patentable weight because it does not change the structure of the nucleic acid. With respect to any function or characteristic (binds a SEFIR domain of an ACT1 protein), the product taught by ‘283 has the same sequence. Thus, any function or characteristic not disclosed in the prior art would be considered an inherent property of the nucleic acid taught by ‘283. In addition, the specification does not appear to provide a definition for the limitation ‘level that that is therapeutic for treating IL-17a related disease or condition’. In view of the broadest reasonable interpretation of the limitation, the claimed embraces any amount of the nucleic acid. Furthermore, the limitation is directed to an intended use of the composition.
Claims 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Deutekom et al. (WO2006112705).
‘705 teaches a pharmaceutical preparation comprising an antisense oligonucleotide (AON) that reads on a sequence comprising instant SEQ ID NO: 103 (Qy). See H46AON25 (SEQ ID NO: 22, Db) in table 1 on page 27 and 39-41. The AON can have a 2’-O-methyl RNA and a phosphorothioate backbone.
Qy 1 AAGANNNUCUU 11, wherein N is A or U
Db 6 AAGAUAUUCUU 16
The term “SBE nucleic acid” recited in claim 18 does not change the structure of the nucleic acid from the AON taught by ‘705. The limitation ‘which is not naturally occurring’ does not have patentable weight because it does not change the structure of the nucleic acid. With respect to any function or characteristic (binds a SEFIR domain of an ACT1 protein), the product taught by ‘705 has an AON that has the same sequence. Thus, any function or characteristic not disclosed in the prior art would be considered an inherent property of the nucleic acid taught by ‘705. In addition, the specification does not appear to provide a definition for the limitation ‘level that that is therapeutic for treating IL-17a related disease or condition’. In view of the broadest reasonable interpretation of the limitation, the claimed embraces any amount of the AON in a pharmaceutical preparation. Furthermore, the limitation is directed to an intended use of the composition.
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 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11352630. Although the claims at issue are not identical, they are not patentably distinct from each other because both set of claims embrace a composition comprising a nucleic acid sequence comprising an SBE nucleic acid that binds a SEFIR domain of an ACT1 protein, the only difference is the claims of ‘630 do note recite the sequence shown in SEQ ID NO: 1, 2, or 103. However, one of ordinary skill in the art looking for the definition of the sequence or what sequences are embraced by the claims of ‘630 would refer to the disclosure of ‘630 and determine that SEQ ID NOs: 1, 2, or 103 are embraced by the claims of ‘630. See MPEP 804(II).B.1. Columns 1 and 10-12 of ‘630 disclose using the sequences in the composition and the methods of the claims of ‘630. Figures 11 and 12 of ‘630 disclose instant SEQ ID NOS: 1 and 2. Figure 16 of ‘630 discloses instant SEQ ID NO: 103 Thus, the claims of ‘630 make obvious the composition set forth in the instant claim 18. Claim 13 of ‘630 makes obvious instant claim 19 directed to the nucleic acid comprising a modified base to improve stability in vivo. Claim 17 of ‘630 makes obvious the limitation in instant claim 20.
Conclusion
See attached PTO-326 for disposition of claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Whiteman whose telephone number is (571)272-0764. The examiner can normally be reached on Monday thru Friday; 6:00 AM to 3:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at (571)-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN WHITEMAN/ Primary Examiner, Art Unit 1636