DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 28, 2025 has been entered.
Claims 1-110, 112, 113, 120, and 122-130 have been canceled.
Claims 111, 117-119, 121
Claims 131-140 have been added.
Claims 111, 114-119, 121, and 131-140 are pending in the instant application.
Information Disclosure Statement
The IDS form received 8/28/2025 is acknowledged and the references cited therein have been considered.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
The rejection of claims 123-127, 129, and 130 under pre-AIA 35 U.S.C. 102(e) as being anticipated by Zhao et al. (WO 2010/111414) has been rendered moot by the cancelation of the indicated claims as part of the August 28, 2025 response.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
The rejection of claims 111-122 and 128 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zhao et al. (WO 2010/111414) has been withdrawn in view of applicant’s claim amendment received August 28, 2025.
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 111, 114-119, 121, and 131-140 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 9,050,318 in view of Peters et al. (US 7,404,956).
The issued claims of the ‘318 patent recite methods for reducing bleeding episodes in human patients, including hemophilia A patients by administering multiple doses of a FVIII polypeptide, wherein the FVIII polypeptide is in a monomer-dimer form wherein one copy of FVIII is fused to a dimeric Fc domain, with such constructs being defined by SEQ ID number (see all issued claims, particularly claims 1, 2, 24, and 26-31). The issued claims recite specific dosing in the range of 25-65 IU/kg as well as specific values including 65 IU/kg, as well as repeat administrations every 3-7 days, with exact intervals of 3, 4, and 5 days being explicitly claimed (see for example issued claims 1, 6, 7, 9-11, 18-20, 24, and 26). Notably such claims treat an active bleeding event (see particularly issued claim 3). The FVIII domain of the administered monomer-dimers are recited as being pegylated (issued claim 14) as having full or partial deletions of the B domain (issued claims 15 and 25), and as having desirable area under the curve functional properties (see for example issued claim 16). Time intervals between administrations are also recited in the issued claims, such as 3-7 days (see for example issued claim 1) as well as specific integer days including 3, 4, and 5 (see for example claims 7 and 10). It should be noted that the application giving rise to the ‘318 patent is a parent of the instant application to which priority has bene claimed via a long string of CON and DIV applications and as such the instant and issued recited SEQ ID numbers are the same biological sequences (compare instant claim 119 to issued claims 27-30 and instant claim 140 to issued claim 31). The issued claims differ from what has been presently claimed in that the issued claims never recite that the administration is via an intravenous route.
Peters et al. disclose the synthesis and use of monomer-dimer type constructs (for visual reference see Figure 1 of Peters et al) for treating numerous conditions, including monomer dimers wherein the therapeutic protein is a coagulation factor such as FVIII and administration is performed to correct hemostatic disorders such as hemophilia A as well as to provide generic hemostasis to patients in need thereof including those undergoing surgical procedures prophylactically as well as to inhibit active bleeding (see entire document, particularly the abstract, claims, and columns 16, 33, and 34). Peters et al. further disclose that such constructs are to be intravenously administered to subjects in pharmaceutical compositions comprising one or more excipients (see particularly columns 33-35).
Therefore, it would have been obvious to ordinary artisans that the administration methods of the issued claims could also be practiced via an intravenous route as such methods for coagulation factor-Fc constructs, including FVIII-Fc were known in the prior art as taught by Peters et al. It would also have been obvious to artisans that such a chimeric proteins would need to be formulated with one or more excipients in order to actually perform the administration to a subject as was also taught explicitly by Peters et al.
Applicant's arguments filed August 28, 2025 have been fully considered but they are not persuasive. Applicant states they disagree with the rejection but will consider filing a terminal disclaimer at a later time if it advances prosecution.
Given that applicant has not filed a terminal disclaimer nor amended the instant claims such that they are not obvious variants of what has been previously patented the rejection is maintained.
Claims 111, 114-119, 121, and 131-140 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-64 of U.S. Patent No. 11,266,720. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are narrower in scope and therefore anticipate that which is presently claimed.
The issued claims of the ‘720 patent recite methods for reducing bleeding episodes in human hemophilia A patients by administering multiple doses of a FVIII polypeptide joined to an immunoglobulin Fc domain via the intravenous route (see all issued claims, particularly claims 1, 6, and 22). The issued claims further recite that the FVIII polypeptide is in a monomer-dimer form wherein one copy of FVIII is fused to a dimeric Fc domain, with such constructs being defined by SEQ ID number (see all issued claims, particularly claims 4, 5, 7-10, and 23-26). The issued claims recite specific dosing in the range of 25-100 IU/kg as well as specific values including 50 and 80 IU/kg (see for example issued claims 1, 19-22, 30-33, 36-39, 42-45, 47, and 49). Notably such claims are prophylactic as well as treating an active bleeding event (see for examples claims 1, 6, and 22). The FVIII domain of the administered monomer-dimers are recited as being pegylated (see for example issued claims 29, 35, 41, 53, and 63) as having deletions of the B domain (issued claims 11, 17, and 27). Time intervals between administrations are also recited in the issued claims, such as 3-5 days (see for example issued claims 1, 22, 40, 46, and 47). It should also be noted that the application giving rise to the ‘720 patent is the immediate parent of the instant application related as a continuation.
Applicant's arguments filed August 28, 2025 have been fully considered but they are not persuasive. Applicant states they disagree with the rejection but will consider filing a terminal disclaimer at a later time if it advances prosecution.
Claims 111, 114-119, 121, and 131-140 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 10,786,554. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate the breadth of what is presently claimed.
The issued claims of the ‘554 patent recite methods for reducing bleeding in hemophilia A patients by administering pharmaceutical compositions comprising defined amounts FVIII-Fc fusion proteins in combination with excipients including buffers and surfactants wherein the fusion proteins are in a monomer-dimer form defined by SEQ ID number (see all issued claims, particularly claims 1, 7, 30, and 37-42). Notably such administration are recited as being performed intravenously (see for example claims 6 and 27) and as being performed every 3-5 days and in amounts of 25-65 IU/kg (see for example claims 4, 25, and 29). Since the issued claims comprise more limitations than what is recited in the instant claims, the issued claims anticipate the inventions as presently claimed.
Applicant's arguments filed August 28, 2025 have been fully considered but they are not persuasive. Applicant argues that it if the instant application were to be granted, a) it is not a second patent of the subject matter of the reference patents and b) it must be shown that issuance of the instant application would effectively extend the life of the reference patents. Applicant has stated that the reference issued patent has a priority date and a base expiration date later than that of the instant application. Applicant also cites case law that in applicant’s opinion indicates that the issue of potential non-common ownership of patents covering the same subject matter is irrelevant and immaterial.
These arguments have been considered and are not persuasive. First, the rejection sets forth why the issued claims anticipate the breadth of what is presently claimed, and clearly indicates that the issued claims are issued (i.e. it is not a “provisional” rejection). Thus applicant’s assertion that the instant claims would not constitute a “second” patent of the same subject matter is not persuasive as a narrower teaching (such as the issued claims) anticipates a broader teaching (such as the instant pending claims). Second, as set forth in the judicial rational, two goals are set forth. Specifically a) “to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent” and b) “to prevent possible harassment by multiple assignees.”. The following flowchart from MPEP 804 concerning double patenting issues between and issued patent and a pending application is reproduced below:
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804
558
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It should be pointed out that such a decision tree does not require a guarantee that the application expires later than the issued patent, and that said decision tree emphasizes the issue of ownership as different rejections are appropriate based upon the how the inventive entity differs when comparing the instant and issued claims. Given such guidance in the MPEP, applicant’s assertions in particular about the irrelevance of the need to prevent possible harassment by multiple assignees cannot be found persuasive.
Claims 111, 114-119, 121, and 131-140 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,221,455. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate the breadth of what is presently claimed.
The issued claims of the ‘455 patent recite administering factor FVIII-Fc fusion proteins to hemophilia A patients who have an inhibitory response directed toward FVIII (see all issued claims). Such patients are recited as receiving the FVIII-Fc fusion proteins intravenously (see particularly claim 20) every 3-7 days at between 25-65 IU/kg (see particularly claims 17 and 18). Such fusion proteins are recited as comprising a B domain deletion, as being in a monomer-dimer format, and as having specific biological sequences defined by SEQ ID number (see particularly claims 11-14). Since the issued claims comprise more limitations than what is recited in the instant claims, the issued claims anticipate the inventions as presently claimed.
Applicant's arguments filed August 28, 2025 have been fully considered but they are not persuasive. Applicant’s arguments are the same as those presented concerning the double patenting rejection over the issued claims of US 10,786,554.
Applicant’s arguments have been found not persuasive as previously discussed in this office action. See above.
The rejection of claims 123-127 and 129-130 on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,186,375 in view of Peters et al. (US 7,404,956) has been withdrawn in view of applicant’s claim amendments received August 28, 2025.
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641