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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 69 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 69 depends on any of claims 1, 4, 6, 9 and adds a limitation that the patient has intact or impaired renal function. Those two options for renal function cover all possibilities, therefore claim 69 does not further limit claims on which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 4, 6, 9, 48-51, 64-65, 68-70, 72, 74-77 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anonymous (“Lumasiran in the treatment of primary hyperoxaluria type I in all age groups”, 14 July 2020, pages 1-3, cited from IDS) as evidenced by Hauptmann et al (WO 2018/185241, October 2018).
Concerning claims 1, 6, 48-51, 64, 70, 74 Anonymous disclose methods of treatment of primary hyperoxaluria type 1 in human subjects of body weight less than 10 kg (see page 2) by administering lumasiran through loading dose of 6 mg/kg once a month for 3 months and maintenance dose of 3 mg/kg once a month (see page 2). Lumasiran is a double-stranded RNA compound consisting of instant SEQ ID NOs: 213 and 330 and a ligand at 3’ end of sense strand identical to claimed in instant claims 49-51, 70, 72 as taught by Hauptmann (see pages 66-67). Anonymous do not specifically point out pediatric population treatment, but specifies that adults and children can be treated (see page 1), meaning that pediatric population can be treated by instant methods.
Concerning claim 4, 9, 72, 75 Anonymous disclose methods of treatment of primary hyperoxaluria type 1 in pediatric subjects of body weight of 10-20 kg (see page 2) by administering lumasiran through loading dose of 6 mg/kg once a month for 3 months and maintenance dose of 6 mg/kg once a month (see page 2).
Concerning claims 65, 76-77 Anonymous disclose pharmaceutical compositions comprising lumasiran (see page 1).
Concerning claim 68 Anonymous disclose subcutaneous administration of lumasiran (see page 2).
Concerning claim 69 the patient can have intact or impaired renal function, covering all possible states of renal function (see 112 rejection above).
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) 1-2, 4-7, 9-10, 48-51, 64-79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anonymous, above, as applied to claims 1, 4, 6, 9, 48-51, 64-65, 68-70, 72, 74-77, and in further view of Erbe (WO 2019/014491, January 2019, of record) and O'Hara (Aust Prescr., 2016, 39: 208-210, of record).
Teachings of Anonymous are discussed above.
Anonymous do not teach administration of further doses as in instant claims 2, 5, 7, 10, 71, 73, or administration of lumasiran in a salt form, or administration of additional therapeutic agent.
Erbe teaches methods of treatment of primary hyperoxaluria comprising administering double stranded RNAi agent that inhibits expression of HAO1 (see lines 10-15 on page 2), exemplifying the methods by administering double stranded siRNA AD-65585 with antisense strand of SEQ ID NO: 15 with all modified nucleotides (see lines 3-7 on page 101): usAfsuauUfuCfCfaggaUfgAfaagucscsa, wherein lower case letters refer to 2'-OMe modified nucleotides and nucleotides with "f" after nucleotide letter are 2'-F modified (see Table B), same as lumasiran (see lines 9-10 on page 105). Erbe teaches administration in a salt form (see lines 18-21 on page 84) and administration of additional therapeutic agents (see lines 8-11 on page 86).
O'Hara teach pharmacokinetics of drugs and drug doses in pediatric population based on child's age and weight (see Abstract).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to improve treatment taught by Anonymous by methods taught by Erbe and develop further administration treatments based on teachings of O’Hara. One of the ordinary skill in the art would be motivated to do so, because Erbe discusses treatment of the same disease with the same compound and O’Hara provide teachings to further improve treatments such as additional administration of active compound.
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 1-2, 4-7, 9-10, 48-51, 64-79 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,478,500 in view of Anonymous, Erbe and O'Hara, above. Claims from '500 recite the siRNA targeting HAO1 of the same sequence as lumasiran (see claim 19). Teachings of Anonymous, Erbe and O'Hara are discussed above. It would have been obvious to treat pediatric subjects with siRNA from '500 with a treatment regimen as in instant claims based on teachings of Anonymous, Erbe and O'Hara.
Claims 1-2, 4-7, 9-10, 48-51, 64-79 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,446,380 in view of Anonymous, Erbe and O'Hara, above. Claims from '380 recite the siRNA targeting HAO1 of the same sequence as lumasiran (see claim 1). Teachings of Anonymous, Erbe and O'Hara are discussed above. It would have been obvious to treat pediatric subjects with siRNA from '380 with a treatment regimen as in instant claims based on teachings of Anonymous, Erbe and O'Hara.
Claims 1-2, 4-7, 9-14, 25, 48-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,261,447 in view of Anonymous, Erbe and O'Hara, above. Claims from '447 recite methods of treating of human subjects by limasiran (see claim 1). Teachings of Anonymous, Erbe and O'Hara are discussed above. It would have been obvious to modify methods from '447 for treatment of pediatric subjects with a treatment regimen as in instant claims based on teachings of Anonymous, Erbe and O'Hara.
Claims 1-2, 4-7, 9-14, 25, 48-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 18-28, 32-41 of copending Application No. 17/579655 in view of Anonymous, Erbe and O'Hara, above. Claims from '655 recite methods of treating of human subjects by lumasiran (see claim 1). Teachings of Anonymous, Erbe and O'Hara are discussed above. It would have been obvious to modify methods from '655 for treatment of pediatric subjects with a treatment regimen as in instant claims based on teachings of Anonymous, Erbe and O'Hara.
This is a provisional nonstatutory double patenting rejection. It is noted though that Notice of Allowance was issued 04/20/2026.
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive.
Previous rejections are withdrawn in view of new amendments, arguments are moot.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 06/10/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
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.
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/EKATERINA POLIAKOVA-GEORGANTAS/ Primary Examiner, Art Unit 1637
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