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 .
Claim Warnings
Applicant is advised that should claim 36 be found allowable, claim 41 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 36 and 41 recite identical methods, the only difference is that SEQ ID NO: 3 is presented as structural formula in claim 36 and is recited as chemical formula in claim 41 with the same modifications described in words.
Applicant is advised that should claim 37 be found allowable, claim 42 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 37 and 42 recite identical methods, the only difference is that SEQ ID NO: 3 is presented as structural formula in claim 36 and is recited as chemical formula in claim 42 with the same modifications described in words.
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) 36-42 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prakash et al (WO 2014/179626, November 2014, cited from IDS) and in further view of Viney et al (WO 2017/079745, May 2017, cited from IDS).
Prakash teach treatment of familial chylomicronemia syndrome (FCS) (see lines 31-32 on page 31, lines 25-35 on page 35, lines 10-15 on page 171) by administering conjugated antisense oligonucleotide identical to instantly claimed presented on page 13. Such compound can be in the form of sodium salt (see lines 17-20 on page 37) and can be administered subcutaneously (see line 16 on page 38). The subject to treat can be human (see line 33 on page 97) with triglycerides level higher than 1000 mg/dL (see lines 10-15 on page 96).
Prakash do not teach administration once every four weeks with 50 mg or 80 mg of the compound.
Viney teach methods of administration of oligonucleotides with GalNAc conjugate group to humans (see Abstract) such as compound on page 62, identical to instantly claimed. The compound can be administered to human subjects in the amount of 80 mg (see lines 10-15 on page 63) or 50 mg (see lines 7-9 on page 20) every four weeks (see claim 140 on page 94).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to administer claimed compound for FCS treatment described by Prakash according to dose regimen taught by Viney, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so, because Prakash teach using the claimed compound for FCS treatment and Viney suggest specific dosages and regimens for the same compound administration.
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 36-42 and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 9,593,333 in view of Prakash and Viney, above. Claims from ‘333 recite methods of treatment of FCS by administration of compound of SEQ ID NO: 3, identical to instant SEQ ID NO: 3, but without conjugate group. Teachings of Prakash and Viney are discussed above. It would have been obvious to administer the same sequence SEQ ID NO: 3 from ‘333 with conjugate group as taught by Prakash using dosing regimen taught by Viney for treatment of FCS, arriving at instant invention.
Claims 36-42 and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35-54 of copending Application No. 17/372,173 in view of Prakash and Viney, above. Claims from ‘173 recite methods of treatment of FCS by administration of compound of SEQ ID NO: 3, identical to instant SEQ ID NO: 3, but without conjugate group. Teachings of Prakash and Viney are discussed above. It would have been obvious to administer the same sequence SEQ ID NO: 3 from ‘173 with conjugate group as taught by Prakash using dosing regimen taught by Viney for treatment of FCS, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection.
Claims 36-42 and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-45 of U.S. Patent No. 9,157,082 in view of Prakash and Viney, above. Claims from ‘082 recite methods of treatment of familial chylomicronemia by administration of compound of SEQ ID NO: 3 (see Example 1), identical to instant SEQ ID NO: 3, but without conjugate group. Teachings of Prakash and Viney are discussed above. It would have been obvious to administer the same sequence SEQ ID NO: 3 from ‘082 with conjugate group as taught by Prakash using dosing regimen taught by Viney for treatment of familial chylomicronemia, arriving at instant invention.
Claims 36-42 and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-50 of U.S. Patent No. 9,932,581 in view of Prakash and Viney, above. Claims from ‘581 recite compound of SEQ ID NO: 87 (see Table A in columns 217-218), identical to instant SEQ ID NO: 3, which can comprise conjugate group identical to instantly claimed (see claim 1) and can be used for treatment of familial chylomicronemia (see lines 30-40 in column 217). Teachings of Prakash and Viney are discussed above. It would have been obvious to administer the same sequence SEQ ID NO: 87 from ‘581 with conjugate group as taught by Prakash using dosing regimen taught by Viney for treatment of familial chylomicronemia, arriving at instant invention.
Claims 36-42 and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/020,893 in view of Prakash, above. Claims from ‘893 recite oligomeric compounds, which can be structure shown in paragraph {0211], identical to the compound instantly claimed. The compound can be used for treatment of familial hypertryglyceridemia (see paragraph [0213]) in the amount of 50 mg (see embodiment 82) or 80 mg (see paragraph [0215]) every four weeks (see embodiment 116). Teachings of Prakash are discussed above. It would have been obvious to treat FCS as taught by Prakash using compound and dosing regimen described in ‘893, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection.
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