DETAILED ACTION
Notice of 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
Applicant’s election without traverse of species 6.0mg, claims 46-53, in the reply filed on 18 May 2026 is acknowledged. The requirement is deemed proper and therefore made Final.
Status of Application
Claims 36-53 are pending. A review of the prior art and application did not result in the finding of the elected dosage species of 6.0 mg, thus, the 0.6 mg dose was necessarily examined as well. Thus, claims 36-53 are subject to examination on the merits.
Priority
The instant application is a 371 of PCT/US2021/060678 filed 24 November 2021 which claims benefit of US Provisional applications 63216601, 63155012, 63117545 filed 30 June 2021, 01 March 2021 and 24 November 2020, respectively.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 18 May 2026, 13 October 2025 and 04 April 2025 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Claim Objections
Claim 36 is objected to because of the following informalities: the first time an acronym is utilized in a claim set, it should be spelled out. Thus, “VFW” should be ‘von Willebrand factor (VWF)’ in its first instance in the claim.
Claims 36 and 46 are objected to for having an extraneous period in said claims, namely, in the sequence identifier (i.e. “SEQ ID NO.:”).
Appropriate corrections are required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 39 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 39 recites the limitation "wherein the increased Factor VIII in the blook maintain at least half of the increase induced by BT200 for at least 1 week post dosing of the VFW binding agent" in reference to claim 36. There is insufficient antecedent basis for this limitation in the claim because claim 36 does not recite “BT200”.
Claim 41 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim recite that the activity of FVIII in the blood is increased. However, any asserted improvement in/for anything needs a comparative. That is, increased compared to what?
Thus, it is suggested to include a comparative similar to that in claim 36 regarding the FVIII levels (i.e. increased compared to the activity prior to 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 36-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6-8, 12, 14 of copending Application No. 18812463 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘463 application are an obvious variation of the instant claims.
The instant claims in their broadest are drawn to a method for increasing the level of Factor VIII in the blood in a subject in need thereof comprising administering to the subject an VWF binding aptamer comprising the sequence of SEQ ID NO.: 6, at a single dose of 0.6mg or 6.0 mg, wherein the level of Factor VIII is increased 2 fold or 50% from the baseline Factor VIII level prior to dosing. Dependent claims 43 and 49 recites the administration is via subcutaneous administration. Dependent claims 44 and 50 recites the subject has subnormal levels of Factor VIII.
The claims to the ‘463 application in their broadest are drawn to: method for treating bleeding associated with von Willebrand's disease (VWD) in a subject comprising administering to the subject a Von Willebrand factor (VWF) targeting agent which comprises a sequence presented by SEQ ID NO: 6, wherein the VWF targeting agent is administered to the subject at a dose ranging from 0.6 mg to 9.0 mg (claim 1). Dependent claims 6-8 recites the dose is 0.6 to 6.0mg, 0.6mg and 6.0mg, respectively. Dependent claim 12 recites the administration is via subcutaneous administration. Dependent claim 14 recites VWF targeting agent increases the levels and/or activity of FVIII in the blood.
Therefore, given the claims of the ‘463 application recite the same dosage levels, such as in claim 8, and that the activity or levels in the blood in the patient having VDW is increased, then inherently, the level of increase will be at least two-fold given all other factors and conditions are the same. With regard to a single dose as currently claimed, the claims to the ‘463 application recite administering “a dose”, which can be interpreted as a single or multiple doses.
It is noted instant SEQ ID NO: 6 and SEQ ID NO: 6 of the ‘463 application have 100% sequence identity to one another – See Supplemental content, 20251229_102542_us-18-253-975-6.rnpbm file, Result #1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 16 June 2026
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