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
Election of species in Applicant’s reply filed on 02/19/2026 of the first structure of T as shown in claim 1 is acknowledged. Upon further consideration election of species of constituent T is withdrawn.
Claim Rejections - 35 USC § 103
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(s) 1-4, 6, 8, 27-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaye (US 2014/0315862, October 2014, cited from IDS) and in further view of Watanabe et al (US 2013/0211062, August 2013) and Hanson (US 2012/0289457, November 2012, cited from IDS).
Kaye teaches compositions for treatment of muscular dystrophy (see Abstract), such as antisense oligomer eteplirsen with the following structure (see paragraph [0063]):
PNG
media_image1.png
237
503
media_image1.png
Greyscale
Such antisense oligomer satisfies structural requirements of instant claims 1-4, 6 and 8 with the first T substituent as presented in instant Formula (I), but missing the targeting peptide on 3’ end. Kaye teaches that the oligomer can be conjugated to arginine-rich peptides (see paragraph [0031]).
Kaye further teaches that thymine in the oligomer can be uracil (see paragraph [0132]). Kaye teaches hydrochloride (HCl) salts of the oligomer (see paragraph [0179]). Kaye teaches pharmaceutical compositions of the oligomer comprising pharmaceutically acceptable carriers (see paragraph [0031]).
Kaye do not teach oligomers comprising two other T substituents as in Formula (I) or conjugation to specific peptide at 3’ end as in Formulas (I) and (II).
Watanabe teach antisense oligomers for treatment of Duchenne muscular dystrophy (see paragraphs [0001-0002]). Watanabe teach modifying 5’ end of such oligomer with groups (1)-(3) from paragraph [0028], which are identical to T substituents as in instant Formula (I) and presented in the same order, wherein R1 is CH3.
Hanson teaches conjugation of oligonucleotides to arginine-rich peptides to increase such oligomer cellular uptake (see Abstract, paragraph [0008]). Hanson suggests attaching peptide comprising six arginines through glycine moiety at the carboxy terminus of the peptide (see paragraphs [0014, 0111]) and acetylating amino terminus of the peptide (see paragraph [0133]). Hanson exemplifies such peptides as AcR6G, which comprises six arginines, the last one acetylated, which are connected to oligomer through glycine moiety (see paragraph [0477]), forming the exact same structure as at 3’ end of instant Formulas (I) and (II). Hanson points out that conjugate with six arginines is the most effective (see paragraph [0484]). Hanson also teach the same oligonucleotide for conjugation of SEQ ID NO: 32 (see Table 1 on page 26) as instant SEQ ID NO: 1.
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify conjugate taught by Kaye at its 5’ and 3’ ends with modifications taught by Watanabe and Hanson, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so, because Watanabe suggest two other ways to modify 5’ end of the conjugate, while Hanson teaches effective peptide modification of 3’ end of oligomer to improve such oligomer delivery to cells, such peptide modification is also suggested by Kaye.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 4, 6, 8 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 4, 6 of prior U.S. Patent No. 11,642,364. This is a statutory double patenting rejection.
With different wording and presentation of the sequence both claims, 4 and 1 from ‘364, recite identical oligomer conjugates.
Instant claim 6 recites the same conjugate or pharmaceutically acceptable salt thereof as in claim 4 from ‘364.
With different wording and presentation of the sequence both claims, 8 and 6 from ‘364, recite identical oligomer conjugates.
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 1-4, 6, 8, 27-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,888,578. Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘578 recite methods of treatment of Duchenne muscular dystrophy by administering the same compounds as instantly claimed.
Claims 2-3, 27-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3, 5, 7-10 of prior U.S. Patent No. 11,642,364. Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘364 recite the same compounds as in instant claims.
Claims 1-4, 6, 8, 27-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-81 of U.S. Patent No. 9,161,948 in view of Watanabe et al, above. Claims from ‘948 recite oligomer conjugates comprising 5’ group identical to the first T substituent from instant Formulas (I) and (II) and 3’ group identical to the same in instant Formulas (I) and (II). Specification of ‘948 further teach SEQ ID NO: 32 in Table 1, column 47, identical to instant SEQ ID NO: 1. Teachings of Watanabe are discussed above. It would have been obvious to modify SEQ ID NO: 32 as described in ‘948 or with modifications discussed by Watanabe, arriving at instant invention.
Claims 1-4, 6, 8, 27-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 9,506,058 in view of Watanabe et al and Hanson, above. Claims from ‘058 recite methods of treatment of Duchenne muscular dystrophy by administering eteplirsen, which has a structural formula (see columns 13-14) identical to instant Formulas (I) and (II), but without 3’ peptide group. Teachings of Watanabe and Hanson are discussed above. It would have been obvious to modify eteplirsen with modifications discussed by Watanabe and Hanson, arriving at instant invention.
Claims 1-4, 6, 8, 27-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 8,779,128 in view of Watanabe et al, above. Claims from ‘128 recite oligomer conjugates comprising 5’ group identical to the first T substituent from instant Formulas (I) and (II) and 3’ group identical to the same in instant Formulas (I) and (II). Specification of ‘128 further teach SEQ ID NO: 32 in Table 11, column 123, identical to instant SEQ ID NO: 1. Teachings of Watanabe are discussed above. It would have been obvious to modify SEQ ID NO: 32 as described in ‘128 or with modifications discussed by Watanabe, arriving at instant invention.
Claims 1-4, 6, 8, 27-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,202,602 in view of Watanabe et al, above. Claims from ‘602 recite oligomer conjugates comprising 5’ group identical to the first T substituent from instant Formulas (I) and (II) and 3’ group identical to the same in instant Formulas (I) and (II). Specification of ‘602 further teach SEQ ID NO: 32 in Table 11, column 123, identical to instant SEQ ID NO: 1. Teachings of Watanabe are discussed above. It would have been obvious to modify SEQ ID NO: 32 as described in ‘602 or with modifications discussed by Watanabe, arriving at instant invention.
Claims 1-4, 6, 8, 27-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 10,487,326 in view of Watanabe et al, above. Claims from ‘326 recite oligomer conjugates comprising 5’ group identical to the first T substituent from instant Formulas (I) and (II) and 3’ group identical to the same in instant Formulas (I) and (II). Specification of ‘326 further teach SEQ ID NO: 32 in Table 1, column 49, identical to instant SEQ ID NO: 1. Teachings of Watanabe are discussed above. It would have been obvious to modify SEQ ID NO: 32 as described in ‘326 or with modifications discussed by Watanabe, arriving at instant invention.
Claims 1-4, 6, 8, 27-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,732,259 in view of Watanabe et al, above. Claims from ‘259 recite oligomer conjugates comprising 5’ group identical to the first T substituent from instant Formulas (I) and (II) and 3’ group identical to the same in instant Formulas (I) and (II). Specification of ‘948 further teach SEQ ID NO: 32 in Table 1, column 35, identical to instant SEQ ID NO: 1. Teachings of Watanabe are discussed above. It would have been obvious to modify SEQ ID NO: 32 as described in ‘259 or with modifications discussed by Watanabe, arriving at instant invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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, Jennifer Dunston can be reached at (571)272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
Prosecution Insights