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 § 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) 42-44, 48, 62-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akinc et al (US 2013/0317081, November 2013, cited from IDS) as evidenced by Fryar et al (National Center for Health Statistics, 2016, 3: 39, cited from IDS).
Concerning claims 42-43, 48 Akinc et al teach a dsRNA in Table 15 on page 79 named AD-57213.1 comprising sense and antisense strands 100% identical to instant SEQ ID NOs: 13 and 14, with 3' end of sense strand conjugated to the same compound as in instant claim 42, named L96 and shown in paragraph [0017]. Further Akinc et al provides kits comprising such dsRNA with the means for administering it to a subject (see paragraph [0046]), which can be human (see paragraph [0007]). Means for administration can be injection device for subcutaneous administration to a human (see paragraph [0368]). Concerning claims 62-65 human subject can be hemophilia A or B patient with or without inhibitors (see paragraph [0119]). Concerning claim 44 Akinc et al teach that dsRNA can be formulated in phosphate - buffered saline (PBS) (see paragraph [0379]). Akinc et al further teach that dsRNA can be administered in a variety of doses from about 0.5 mg/kg to 50 mg/kg (see paragraph [0043]).
Akinc et al do not teach specific dose of dsRNA of 50 mg.
Fryar et al provides evidence for average weight of adult male, 88.8 kg, or adult female, 76.4 kg, human (see pages 7 and 9). Given the administration doses taught by Akinc et al as above, the range of doses taught is between 76.4x0.5=38.2 mg and 88.8x50=4440 mg. According to MPEP 2144.05, if the claimed range lie inside range disclosed by prior art a prima facie case of obviousness exists.
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to obtain dose of dsRNA such as 50 mg based on teachings of Akinc et al as evidenced by Fryar et al. Akinc et al teach a range of doses between 38 mg and 4440 mg, making it obvious to obtain a number of fixed dosages such as 40 mg, 50 mg, 60 mg, etc. for treatment of patients of various weights. MPEP 2143 (I) (E) teach that it is obvious to choose from a finite number of identified, predictable solution with a reasonable expectation of success. Therefore a single dosage of 50 mg will be obvious based on references above.
Limitation "for routine prophylaxis of hemophilia A or B" is of intended use and therefore is not given patentable weight.
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 42-44, 48, 62-65 are rejected on the ground of nonstatutory double patenting as being unpatentable overclaims 1-62 of U.S. Patent No. 9,127,274. Although the claims at issue are not identical, they are not patentably distinct from each other because claims from '274 recite the same dsRNA conjugate as in instant claims, which can be administered for treatment of hemophilia. Further disclosure of '274 describes kits comprising dsRNAs of the invention and means for its administration (see lines 12-20 in column 10), including devices for subcutaneous injection (see lines 30-40 in column 93) and varying dosages of administration (see column 9), such dosages range can be converted to the same range as in 103 rejection above using data provided by Fryar et al, therefore making it obvious to arrive at instant invention.
Claims 42-44, 48, 62-65 are rejected on the ground of nonstatutory double patenting as being unpatentable overclaims 1-55 of U.S. Patent No. 9,376,680. Although the claims at issue are not identical, they are not patentably distinct from each other because claims from '680 recite the same dsRNA conjugate as in instant claims, which can be administered for treatment of hemophilia A or B. Further disclosure of '680 describes kits comprising dsRNAs of the invention and means for its administration (see lines 15-25 in column 10), including devices for subcutaneous injection (see lines 30-40 in column 93) and varying dosages of administration (see column 9), such dosages range can be converted to the same range as in 103 rejection above using data provided by Fryar et al, therefore making it obvious to arrive at instant invention.
Response to Arguments
Applicant's arguments filed 03/23/2026 have been fully considered but they are not persuasive.
Concerning 103 rejection and double patenting rejections Applicant argues that thousands of possible doses are not a finite number of predictable solutions. In response such number is exact finite number, even if it is large. Further Applicant argues that there is no reasonable expectation of success. In response it is reasonable to create any dosage of a drug, thus there is a reasonable expectation of success of creating any dose of a drug. All rejections are maintained.
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.
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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