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 .
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because the “Sequence Listing XML,” as a separate part of the disclosure, is defective, damaged or unreadable.
Refer to document “Sequence Listing in Computer Readable Format is Defective” dated 1/6/26.
Required response - Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above submitted in accordance with either item 1. or 2.; together with
o A statement that identifies the location of all additions, deletions or replacements of sequence information relative to the replaced “Sequence Listing XML” as required by 37 CFR 1.835(b)(3);
o A statement that indicates support for the replacement “Sequence Listing XML” in the application, as filed, as required by 37 CFR 1.835(b)(4); and
o A statement that the replacement “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(b)(5).
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125, inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Specification
The amendment to the specification filed on 1/5/26 has not been entered because the amendment included the original claims and abstract. To comply just file the amended specification without the original claims and abstract. See attached PTO-324 form. Please reply to the non-compliant amendment with the response to the instant office action and do not file separately.
The instant office action is based on the amended claims filed on 1/5/26.
Claim Objections
Claim 20 is objected to because of the following informalities: the limitation ‘abnormal splicing of or COL7A1’ is confusing because of the term “or”. Suggest removing this term. Appropriate correction is required.
Response to Amendment
Any rejection or objection not reiterated herein has been overcome by amendment. Applicant’s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
Upon further consideration of the 103 rejection, the rejection is withdrawn and the Declaration by Dr. Caruthers under 37 CFR 1.130a filed on 1/5/26 is not required to overcome the rejection of claims 1-8, 10-17 and 19-20 based on Chen et al. (Molecules Vol. 21, R1582-1-9, Nov. 2016, cited on an IDS) taken with Sibasish et al. (WO 2018057430, EFD 9/20/16). The WO ‘430 document has two inventors (Marvin Carruthers and Sibasish Paul) and the ‘688 application has five inventors (Marvin Carruthers; Sibasish Paul; Rakesh Veedu; Katarzyna Jastrzebska; and Heera Krishna and two applicants: University of Colorado and Murdoch University). The WO document has a sub-set of the inventors (2/5) and the 102(b)(1)(A) and 102(b)(2)(A) exceptions apply. Thus, the WO ‘430 does not qualify as prior art.
As stated above, the 103 rejection is withdrawn and the Declaration by Dr. Veedu under 37 CFR 1.130a filed on 1/5/26 is not required but would be sufficient to overcome the rejection of claims 1-8, 10-17 and 19-20 based on Chen et al. (Molecules Vol. 21, R1582-1-9, Nov. 2016, cited on an IDS) taken with Sibasish et al. (WO 2018057430, EFD 9/20/16). Dr. Veedu states that the Chen et al. publication was conducted by themselves and the co-authors who conducted work under Dr. Veedu supervision in the same laboratory. The subject matter disclosed in the cited publication from Dr. Veedu and the disclosure was not derived from any other third party. Dr. Veedu further states that the subject matter of the ‘688 application arose from a joint research collaboration between them and the co-inventor prior to the effective filing date of ‘688. ‘688 is jointly owned by Murdoch University and University of Colorado, and the inventors are obligated to and have in fact assigned their rights in the ‘688 application to Murdoch University and the university of Colorado, respectively.
State of the art
The claimed invention is directed to making thiomorpholino oligonucleotides comprising a sequence that is complementary to a target region of an exon of a gene that can be treated by exon skipping of the targeted exon.
The applicants state that they have invented a novel morpholino chemistry to overcome the limitations associated with current PMO-antisense oligonucleotides. See page 3 of the specification.
The specification teaches that one of skill in the art can make the antisense oligonucleotides with at least one thiomorpholino (TMO) without an undue amount experimentation.
The prior art and currently and with the teaching in the specification (pages 1-5) disclose that one of skill in the art can make and use an antisense oligonucleotide embraced by the claimed invention. Targeting splicing in a nucleotide sequence with antisense oligonucleotides has been used for over 20 years. For example, Sazani et al. (J. Clin. Invest. 112; 481-486 2003) teach that antisense oligonucleotides can be made to modulate alternative splicing of several genes thus restoring correct splicing and function of a defective gene. In addition, there are several known antisense oligonucleotides for treatment of spinal muscular atrophy and other disorders. See table 2 of Takeshima (Int. J. Mol. Sci. 2025, 26, 2270).
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 1-20 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11479772, of record. Although the claims at issue are not identical, they are not patentably distinct from each other because both set of claims are directed to a composition comprising an antisense oligonucleotide having at least one thiomorpholino nucleotide (TMO), wherein at least a portion of the TMO is complementary to a target region in an exon of a gene (dystrophin gene). Claims 2-15 of '972 correspond to instant claims 2 and 4-19. When a person of ordinary skill in the art looks for a definition of the antisense oligonucleotides to use in the method of '772, they would arrive at instant SEQ ID NOs: 4-5. See columns 41-42 of '772. Also see MPEP 804(II)(B)(1) Construing the claims using the reference patent disclosure. In addition, column 7 of '772 disclosure which provides a definition for what diseases or disorders can be treated using the antisense oligonucleotide.
Response to Arguments
Applicant's arguments filed 1/5/26 have been fully considered but they are not persuasive.
The filing of a terminal disclaimer does not overcome the NSDP rejection for the following reasons:
The terminal disclaimer identifies a party who is not the applicant (only for applications filed on or after September 16, 2012): For cases filed on/after 9/16/2012, 37 CFR 1.321 specifies that the applicant can disclaim, and the terminal disclaimer must specify the extent of the applicant's ownership.
To remedy this: A request under 37 CFR 1.46(c) to change the applicant needs to be filed, which is (1) a request, signed by a 1.33(b) party, (2) a corrected ADS (37 CFR 1.76(c)) that identifies the "new" applicant in the applicant information, and is underlined since it is new, and (3) a 3.73(c) statement showing chain of title to the new applicant. Along with the § 1.46(c) request we need a POA that gives power to the attorney who is signing the TD, along with another copy of the TD, unless they file a TD that is signed by the applicant.
Note: The applicant cited on the TD must be cited exactly as it is cited on the ADS and or filing receipt and also in its entirety. If more space for applicant section is required, please use smaller fonts or submit an attachment page to the TD. 2. The registration number for the signing attorney is incorrect. Please make corrections as suggested above and also resubmit the TD. (No new fee required).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/BRIAN WHITEMAN/ Primary Examiner, Art Unit 1636