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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/15/2026 had been considered by the examiner.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/15/2026 has been entered.
Claims 1-28 are pending.
Upon review and further consideration of the claims, it was determined that the following issues are warranted,
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 24 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 24 recites the limitation "wherein the BT200" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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 1-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 36-51 of copending Application No. 18/253975 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
It is noted that the ‘975 application was amended on 10/13/2025 cancelling all previous claims and adding new claims 36-51.
The instant claims are drawn to a 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); a method for treating bleeding in a patient diagnosed with von Willebrand's disease (VWD) with a pharmaceutical composition comprising a VWF binding agent, BT200, comprising: a) assessing the baseline coagulation function in said patient; b) determining the optimal dose of BT200 with the assessment of step a) for initial treatment; and c) providing a weekly dose of BT200 after one-week treatment with the initial dose of BT200 in said patient, wherein the initial dose of BT200 is from 0.6 mg to 9.0 mg (claims 20); and a method of increasing the half-life of a FVIII therapy in a patient who receives the FVIII therapy comprising administering to the patient an VWF targeting agent which comprises a sequence presented by SEQ ID NO: 6, and wherein the BT200 is administered at a dose ranging from 0.6 mg to 9.0 mg (claim 24).
The claims of the ‘975 application 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 agent, at a dose of 0.6mg, wherein the Factor VIII level in the blood is increased at least 50% within 48 hours after administering the VWF binding agent to the subject as compared to the level of Factor VIII prior to the administration, and wherein the VWF binding agent comprises the sequence of SEQ ID NO.: 6 (claim 1); and, 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 agent, at a dose of 0.6mg, wherein the Factor VIII level in the blood is increased at least 50% within 48 hours after administering the VWF binding agent to the subject as compared to the level of Factor VIII prior to the administration, and wherein the VWF binding agent comprises the sequence of SEQ ID NO.: 6 (claim 46).
Accordingly, both sets of claims are drawn to methods wherein 0.6mg of an agent that comprises SEQ ID NO: 6, also known as BT200, is administered to a subject. Although the claims of the ‘975 application do not recite treating VWD or treating bleeding associated with VWD wherein the VWD is VWD type 2b, or the exact steps required by claim 20, or increasing the half-life of a FVIII therapy in a patient who receives the FVIII therapy, using the disclosure of the ‘975 application as a dictionary to define the broadly claimed method, it is clear that the ‘975 application indicates that the broadly claimed method encompasses VWD or bleeding associated with VWD wherein the VWD is VWD type 2b (e.g., see title, abstract, paragraphs [0004], [0010], original claim 32, etc.).
Regarding instant claims 4-5, ‘975 indicates that the treatment can be a therapeutic or prophylactic treatment (see original claim 14, [0099], etc.).
Regarding claims 7, claim 36 of ‘975 requires administration of 0.6 mg.
Regarding claims 8, claim 46 of ‘975 requires administration of 6.0 mg.
Regarding instant claims 9-11, ‘975 indicates administration can be every other day, once a week, every other week, etc. (see [0124]-[0126]).
Regarding instant claim 12, ‘975 indicates that administration via subcutaneous injection (see [0139]).
Regarding instant claims 13-15, ‘975 indicates that the agent increases the level and/or activity of VWF and FVIII in the blood and increase platelet counts in the blood (see original claim 9, [0075], etc.).
Regarding instant claims 16-19, ‘975 indicates that agent can be administered in combination with a recombinant FVIII preparation and increase the half-life of the recombinant FVIII at least 3-fold (e.g. see [0103], Table 6, etc.).
Regarding instant claims 20-23, see original claims 32-35 of the ‘975 application.
Regarding instant claims 24-28, see paragraphs [0101], [0103], [0148], Table 6, etc. of the ‘975 application.
Therefore, the ‘975 application claims a method that is an obvious variation and thus not patentably distinct from the instant claims and a non-statutory double patenting rejection is appropriate.
It is noted that MPEP § 804 II B 1 states:
The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)… Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637
Prosecution Insights