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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/18/2025 has been entered.
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 09/18/2025 have been fully considered but they are not persuasive.
Concerning 103 rejection Applicant argues on page 5 that instantly claimed kit is intended for administration to people of various weights. In reply at first such limitation is absent from instant claims and at second even if such limitation would be present, it would not be given patentable weight, because this is intended use limitation.
Further Applicant argues that one of skill in the art would not have reasonable expectation of success arriving at instant invention to create a single dosage unit of 50 mg. In response Akinc reference does teach only weight-based dosages. But one of the ordinary skill in the art is capable of creating any single dosage units such as 10 mg, 20 mg, etc. of any medication, so that the drug can be administered by using only a single dose or a number of single doses, making it obvious to make such single dosage units with a reasonable expectation of success.
Further Applicant argues that there is no reason to choose 50 mg dose based on teachings of Akinc and Fryar. In response 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. Akinc teach weight-based administration, making it obvious to create any single dosage units such as 10 mg, 20 mg, etc, including 50 mg. Any of those dosage units are obvious. The fact that a number of potential dosage units is large does not make any of such dosage units non-obvious. Large number is still a finite number as taught in MPEP 2143 (I) (E).
Applicant keeps arguing on page 6 that “Knowing the average weight of a subject does not provide any motivation to administer a single dose of 50 mg to subjects, regardless of weight, or to produce a kit comprising one single dosage unit of 50 mg of the recited dsRNA molecule.” In response Applicant here conflates two issues: method of administration – “motivation to administer” and kit production. Method of administration is not being claimed in instant claims, therefore it is not relevant to instant claims. Production of the kit is different from method of administration and is made obvious by the references of record.
Double patenting rejections are maintained for the reasons of record.
Conclusion
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637