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 .
Response to Amendment
Applicant’s remarks and amendments to the claims filed 10/24/2025 have been acknowledged. Claims 41-52 are newly added.
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.
Claims 16-22 and 25-52 are rejected under 35 U.S.C. 103 as being unpatentable over Yoneyama (US20170253663A1, of record).
Yoneyama teaches a method of preventing and/or treating a subject having acquired hemophilia A comprising (a) administering to the subject an initial dose of approximately 0.001 to 100 mg/kg of a bispecific antigen-binding molecule that recognizes both (i) coagulation factor IX and/or activated blood coagulation factor IX, and (ii) blood coagulation factor X and/or activated blood coagulation factor X and functionally substitutes for coagulation factor VIII; and (b) administering two or more continued doses of the bispecific antigen-binding molecule to the subject, wherein the time interval between consecutive administrations of the doses is one day or longer, and the amount of the bispecific antigen-binding molecule in each continued dose is approximately the same as, or is less than, the amount in the initial dose (Abstract, Summary of the Invention, Para. 0066, Para. 0067-0070, Para. 0073-0074, Claim 16, and Claims 28-29). Treatment of hemophilia refers to, for example, reducing the bleeding frequency by administering the composition to a patient who had shown bleeding to prevent manifestation of bleeding symptoms in advance (prevention of bleeding) (Para. 0081); as such, prevention of bleeding necessarily encompasses prophylactic administration. Each dose of the bispecific antibody is administered subcutaneously (Claim 34), and each dose is necessarily administered as a single administration. The bispecific antibody can comprise a first heavy chain of SEQ ID NO: 20; a second heavy chain of SEQ ID NO: 25; and a commonly shared light chain of SEQ ID NO: 32 (Para. 0059) (Q499-z121/J327-z119/L404-k, or Emicizumab per the instant specification on Para. 0018). The first heavy chain fully comprises the CDRs of SEQ ID NOs: 1, 2, and 3 as well as the VH chain of SEQ ID NO: 4 recited in the instant claims. The second heavy chain fully comprises the CDRs of SEQ ID NOs: 6, 7, 8 as well as the VH chain of SEQ ID NO: 9 recited in the instant claims. The commonly shared light chain fully comprises the CDRs of SEQ ID NOs: 11, 12, and 13 as well as the VL chain of SEQ ID NO: 14 recited in the instant claims. An initial dose in the range of 0.001 to 100 mg/kg that is administered can be, for example, 6 mg/kg (Para. 0066). Each continued dose can be nearly the same as or less than the initial dose such as approximately one-half, one-third, or one-fourth of the initial dose and so on (Para. 0067). For example, if the initial dose is 6 mg/kg, then a continued dose that is the same as the initial dose would be 6 mg/kg. A continued dose that is one-half the initial dose would be 3 mg/kg. A continued dose that is one-fourth the initial dose would be 1.5 mg/kg. The number of times the continued dose is continually administered is not particularly limited, and the number is for example once, twice, three times, four times, and so on (Para. 0072). An administration interval of one day or longer can include for example 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 4 weeks and so on (Para. 0073). The administration interval between each dose can be the same or vary and be longer or shorter in duration (Para. 0074). Further, it is stated that the dosage regimen for a hemophilia A patient can be determined by considering the effects of preventing bleeding in patients and clinically acceptable safety (Para. 0079). While the specific combination of dosage amounts and administration intervals recited in the claims is not disclosed in Yoneyama the courts have stated "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); thus, it would have been prima facie obvious to one of ordinary skill in the art to determine by routine experimentation the optimum dosage amounts and dosing regimens for the bispecific antibody Emicizumab that encompass different embodiments of the instantly claimed invention. Therefore, the instant claims deemed obvious in view of the teachings of Yoneyama.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yoneyama, as applied to claims 1-22 and 25-52 above, and further in view of Huth-Kuhne et al (Huth-Kühne, Angela, et al. "International recommendations on the diagnosis and treatment of patients with acquired hemophilia A." haematologica 94.4 (2009): 566, of record), hereinafter Huth-Kühne.
The teachings of Yoneymaa have been discussed above and differ from the instantly claimed invention in that it is not taught that an immunosuppressive agent such as a steroid is further administered in the method of treating acquired hemophilia A in a subject.
However, Huth-Kühne teaches international recommendations for the treatment of acquired hemophilia A, including anti-hemorrhagic therapy for acute bleeding control and immunosuppressive therapy such as with corticosteroids for inhibitor eradication to reduce subsequent bleeding risk (see Abstract and Table 1).
It would have been obvious to one of ordinary skill in the art to further administer an immunosuppressive agent such as a corticosteroid in the method of treating acquired hemophilia A in a subject disclosed by Yoneyama. One of ordinary skill in the art would have been motivated to do so since corticosteroids can be used to eradicate autoantibodies (or inhibitors) and reduce subsequent bleeding risk in a subject as taught by Huth-Kühne. Further, the bispecific anti-FIX/FX antibody can be considered a type of anti-hemorrhagic agent that functionally substitutes for coagulation FVIII. Thus, there is a reasonable expectation of success that acquired hemophilia A can be treated with a bispecific anti-FIX/FX antibody (anti-hemorrhagic agent) followed by a corticosteroid (immunosuppressant). Therefore, one of ordinary skill in the art would reasonably expect administering a bispecific anti-FIX/FX antibody followed by an immunosuppressant such as a corticosteroid can effectively treat acquired hemophilia A in a subject.
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 16-22 and 25-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19018152 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims either anticipate or are obvious variants over the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The co-pending claims recite a pharmaceutical composition for use in preventing and/or treating acquired hemophilia A in a subject comprising administering a bispecific factor IX/X antibody having a first heavy chain of SEQ ID NO: 20, a second heavy chain of SEQ ID NO: 25, and a commonly shared light chain of SEQ ID NO: 32, wherein the bispecific antibody is administered at an initial dose of about 0.001 to 100 mg/kg and is continually administered several times at continued doses that are nearly the same as or less than the initial dose and wherein the interval between individual administrations is at least one day or longer (co-pending claims 1, 7, 10, 13, 14, and 15). Prevention of acquired hemophilia a necessarily encompasses prophylactic administration and would reduce/prevent the frequency of bleeding episodes in a subject. The bispecific antibody comprising a first heavy chain of SEQ ID NO: 20; a second heavy chain of SEQ ID NO: 25; and a commonly shared light chain of SEQ ID NO: 32 is known as Q499-z121/J327-z119/L404-k (see Page 12 of co-pending specification); and Q499-z121/J327-z119/L404-k is Emicizumab (see Para. 0018 of instant specification). The first heavy chain fully comprises the CDRs of SEQ ID NOs: 1, 2, and 3 as well as the VH chain of SEQ ID NO: 4 recited in the instant claims. The second heavy chain fully comprises the CDRs of SEQ ID NOs: 6, 7, 8 as well as the VH chain of SEQ ID NO: 9 recited in the instant claims. The commonly shared light chain fully comprises the CDRs of SEQ ID NOs: 11, 12, and 13 as well as the VL chain of SEQ ID NO: 14 recited in the instant claims. Further, the bispecific antibody is administered subcutaneously (co-pending claim 9) and each dose is necessarily given as a single administration. While the specific combination of dosage amounts and administration intervals recited in the instant claims is not recited in issued claims, the courts have stated "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); thus, it would have been prima facie obvious to one of ordinary skill in the art to determine by routine experimentation the optimum dosage amounts and dosing regimens for the bispecific antibody anti-FIX/FX antibody of the issued claims that encompass different embodiments of the instantly claimed invention.
Claims 16-22 and 25-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-84 of U.S. Patent No. 10450381B2 in view of Yoneymama (US20170253663A1, of record).
The issued claims recite a method of treating acquired hemophilia A in a subject comprising administering a pharmaceutical composition comprising a bispecific factor IX/X antibody having a first heavy chain of SEQ ID NO: 20, a second heavy chain of SEQ ID NO: 25, and a commonly shared light chain of SEQ ID NO: 32 (issued claims 36, 38, 39, 40, 41 and 42). The bispecific antibody comprising a first heavy chain of SEQ ID NO: 20; a second heavy chain of SEQ ID NO: 25; and a commonly shared light chain of SEQ ID NO: 32 is known as Q499-z121/J327-z119/L404-k (see Column 11, Ln. 50-56 of issued specification); and Q499-z121/J327-z119/L404-k is Emicizumab (see Para. 0018 of instant specification). The first heavy chain fully comprises the CDRs of SEQ ID NOs: 1, 2, and 3 as well as the VH chain of SEQ ID NO: 4 recited in the instant claims. The second heavy chain fully comprises the CDRs of SEQ ID NOs: 6, 7, 8 as well as the VH chain of SEQ ID NO: 9 recited in the instant claims. The commonly shared light chain fully comprises the CDRs of SEQ ID NOs: 11, 12, and 13 as well as the VL chain of SEQ ID NO: 14 recited in the instant claims.
The issued claims do not recite that the bispecific anti-FIX/FX antibody is administered according to the specific dosage amounts and regimens recited in the instant claims, wherein each dose is administered subcutaneously and provided as a single administration.
However, Yoneyama teaches a method of preventing and/or treating a subject having acquired hemophilia A comprising (a) administering to the subject an initial dose of approximately 0.001 to 100 mg/kg of a bispecific anti-FIX/FX antibody that functionally substitutes for coagulation factor VIII; and (b) administering two or more continued doses of the bispecific anti-FIX/FX antibody to the subject, wherein the time interval between consecutive administrations of the doses is one day or longer, and the amount of the bispecific anti-FIX/FX antibody in each continued dose is approximately the same as, or is less than, the amount in the initial dose (Abstract, Summary of the Invention, Para. 0066, Para. 0067-0070, Para. 0073-0074, Claim 16, and Claims 28-29). Treatment of hemophilia refers to, for example, reducing the bleeding frequency by administering the composition to a patient who had shown bleeding to prevent manifestation of bleeding symptoms in advance (prevention of bleeding) (Para. 0081); as such, prevention of bleeding necessarily encompasses prophylactic administration. Each dose of the bispecific antibody is administered subcutaneously (Claim 34), and each dose is necessarily administered as a single administration. An initial dose in the range of 0.001 to 100 mg/kg that is administered can be, for example, 6 mg/kg (Para. 0066). Each continued dose can be nearly the same as or less than the initial dose such as approximately one-half, one-third, or one-fourth of the initial dose and so on (Para. 0067). For example, if the initial dose is 6 mg/kg, then a continued dose that is the same as the initial dose would be 6 mg/kg. A continued dose that is one-half the initial dose would be 3 mg/kg. A continued dose that is one-fourth the initial dose would be 1.5 mg/kg. The number of times the continued dose is continually administered is not particularly limited, and the number is for example once, twice, three times, four times, and so on (Para. 0072). An administration interval of one day or longer can include for example 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 4 weeks and so on (Para. 0073). The administration interval between each dose can be the same or vary and be longer or shorter in duration (Para. 0074). Further, it is stated that the dosage regimen for a hemophilia A patient can be determined by considering the effects of preventing bleeding in patients and clinically acceptable safety (Para. 0079).
It would have been obvious to one of ordinary skill in the art to modify the method of the issued claims such that the bispecific anti-FIX/FX antibody is administered according to dosage amounts and administration intervals outlined by Yoneyama, wherein each dose is administered subcutaneously and provided as a single administration. One of ordinary skill in the art would have been motivated to do so in order to effectively treat acquired hemophilia A in a subject. Further, the courts have stated "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); thus, it would have been prima facie obvious to one of ordinary skill in the art to determine by routine experimentation the optimum dosage amounts and dosing regimens for the bispecific antibody Emicizumab to arrive at different embodiments of the instantly claimed invention. Therefore, one of ordinary skill in the art would expect that the bispecific anti-FIX/FX antibody of the issued claims can effectively treat acquired hemophilia A in a subject according to optimized dosage amounts and regimens recited in the instant claims determined by routine experimentation.
Claims 23 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-84 of U.S. Patent No. 10450381B2 in view of Yoneymama, as applied to claims 1-22 and 25-52 above, and further in view of Huth-Kuhne et al (Huth-Kühne, Angela, et al. "International recommendations on the diagnosis and treatment of patients with acquired hemophilia A." haematologica 94.4 (2009): 566, of record), hereinafter Huth-Kühne.
The teachings of the issued claims in view of Yoneymaa have been discussed above and differ from the instantly claimed invention in that it is not taught that an immunosuppressive agent such as a steroid is further administered in the method of treating acquired hemophilia A in a subject.
However, Huth-Kühne teaches international recommendations for the treatment of acquired hemophilia A, including anti-hemorrhagic therapy for acute bleeding control and immunosuppressive therapy such as with corticosteroids for inhibitor eradication to reduce subsequent bleeding risk (see Abstract and Table 1).
It would have been obvious to one of ordinary skill in the art to further administer an immunosuppressive agent such as a corticosteroid in the method of treating acquired hemophilia A in a subject disclosed by Yoneyama comprising administering the bispecific antibody of the issued claims. One of ordinary skill in the art would have been motivated to do so since corticosteroids can be used to eradicate autoantibodies (or inhibitors) and reduce subsequent bleeding risk in a subject as taught by Huth-Kühne. Further, the bispecific anti-FIX/FX antibody can be considered a type of anti-hemorrhagic agent that functionally substitutes for coagulation FVIII. Thus, there is a reasonable expectation of success that acquired hemophilia A can be treated with a bispecific anti-FIX/FX antibody (anti-hemorrhagic agent) followed by a corticosteroid (immunosuppressant). Therefore, one of ordinary skill in the art would reasonably expect administering a bispecific anti-FIX/FX antibody of the issued claims followed by an immunosuppressant such as a corticosteroid can effectively treat acquired hemophilia A in a subject.
Claims 1-22 and 25-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 9334331B2 in view of Yoneyama (US20170253663A1, of record).
The issued claims recite a bispecific antibody that specifically binds to blood coagulation factor IX and/or activated blood coagulation factor IX, and specifically binds to blood coagulation factor X, wherein the bispecific antibody comprises: a first antibody H chain comprising SEQ ID NO: 20; a second antibody H chain comprising SEQ ID NO: 25; and identical first and second antibody L chains, each comprising SEQ ID NO: 32 (1, 12, 13, 14, and 25). The bispecific antibody comprising a first heavy chain of SEQ ID NO: 20; a second heavy chain of SEQ ID NO: 25; and a commonly shared light chain of SEQ ID NO: 32 is known as Q499-z121/J327-z119/L404-k (see Column 11, Ln. 44-49 of the issued specification); and Q499-z121/J327-z119/L404-k is Emicizumab (see Para. 0018 of the instant specification). The first heavy chain fully comprises the CDRs of SEQ ID NOs: 1, 2, and 3 as well as the VH chain of SEQ ID NO: 4 recited in the instant claims. The second heavy chain fully comprises the CDRs of SEQ ID NOs: 6, 7, 8 as well as the VH chain of SEQ ID NO: 9 recited in the instant claims. The commonly shared light chain fully comprises the CDRs of SEQ ID NOs: 11, 12, and 13 as well as the VL chain of SEQ ID NO: 14 recited in the instant claims.
The issued claims do not recite a method of treating acquired hemophilia A in a subject comprising administering the bispecific anti-FIX/FX antibody according to the dosage regimens recited in the instant claims, wherein each dose is administered subcutaneously and provided as a single administration.
However, Yoneyama teaches a method of preventing and/or treating a subject having acquired hemophilia A comprising (a) administering to the subject an initial dose of approximately 0.001 to 100 mg/kg of a bispecific antigen-binding molecule that recognizes both (i) coagulation factor IX and/or activated blood coagulation factor IX, and (ii) blood coagulation factor X and/or activated blood coagulation factor X and functionally substitutes for coagulation factor VIII; and (b) administering two or more continued doses of the bispecific antigen-binding molecule to the subject, wherein the time interval between consecutive administrations of the doses is one day or longer, and the amount of the bispecific antigen-binding molecule in each continued dose is approximately the same as, or is less than, the amount in the initial dose (Abstract, Summary of the Invention, Para. 0066, Para. 0067-0070, Para. 0073-0074, Claim 16, and Claims 28-29). Treatment of hemophilia refers to, for example, reducing the bleeding frequency by administering the composition to a patient who had shown bleeding to prevent manifestation of bleeding symptoms in advance (prevention of bleeding) (Para. 0081); as such, prevention of bleeding necessarily encompasses prophylactic administration. Each dose of the bispecific antibody is administered subcutaneously (Claim 34), and each dose is necessarily administered as a single administration. The bispecific antibody can comprise a first heavy chain of SEQ ID NO: 20; a second heavy chain of SEQ ID NO: 25; and a commonly shared light chain of SEQ ID NO: 32 (Para. 0059) (Q499-z121/J327-z119/L404-k, or Emicizumab per the instant specification on Para. 0018). The first heavy chain fully comprises the CDRs of SEQ ID NOs: 1, 2, and 3 as well as the VH chain of SEQ ID NO: 4 recited in the instant claims. The second heavy chain fully comprises the CDRs of SEQ ID NOs: 6, 7, 8 as well as the VH chain of SEQ ID NO: 9 recited in the instant claims. The commonly shared light chain fully comprises the CDRs of SEQ ID NOs: 11, 12, and 13 as well as the VL chain of SEQ ID NO: 14 recited in the instant claims. An initial dose in the range of 0.001 to 100 mg/kg that is administered can be, for example, 6 mg/kg (Para. 0066). Each continued dose can be nearly the same as or less than the initial dose such as approximately one-half, one-third, or one-fourth of the initial dose and so on (Para. 0067). For example, if the initial dose is 6 mg/kg, then a continued dose that is the same as the initial dose would be 6 mg/kg. A continued dose that is one-half the initial dose would be 3 mg/kg. A continued dose that is one-fourth the initial dose would be 1.5 mg/kg. The number of times the continued dose is continually administered is not particularly limited, and the number is for example once, twice, three times, four times, and so on (Para. 0072). An administration interval of one day or longer can include for example 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 4 weeks and so on (Para. 0073). The administration interval between each dose can be the same or vary and be longer or shorter in duration (Para. 0074). Further, it is stated that the dosage regimen for a hemophilia A patient can be determined by considering the effects of preventing bleeding in patients and clinically acceptable safety (Para. 0079).
It would have been obvious to one of ordinary skill in the art to use the bispecific anti-FIX/FX antibody (Emicizumab) of the issued claims in the method of treating acquired hemophilia A in a subject according to the dosage amounts and administration intervals outlined by Yoneyama, wherein each dose is administered subcutaneously and each dose is a single administration. One of ordinary skill in the art would have been motivated to do so because Yoneyama teaches that a bispecific anti-FIX/FX antibody such as Emicizumab recited in the issued claims can be used to treat acquired hemophilia A in a subject. Further, the courts have stated "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); thus, it would have been prima facie obvious to one of ordinary skill in the art to determine by routine experimentation the optimum dosage amounts and dosing regimens for the bispecific antibody Emicizumab to arrive at different embodiments of the instantly claimed invention. Therefore, one of ordinary skill in the art would expect that the bispecific anti-FIX/FX antibody of the issued claims can effectively treat acquired hemophilia A in a subject according to optimized dosage amounts and regimens recited in the instant claims determined by routine experimentation.
Claims 23 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 9334331B2 in view of Yoneyama, as applied to claims 1-22 and 25-52 above, and further in view of Huth-Kuhne et al (Huth-Kühne, Angela, et al. "International recommendations on the diagnosis and treatment of patients with acquired hemophilia A." haematologica 94.4 (2009): 566, of record), hereinafter Huth-Kühne.
The teachings of the issued claims in view of Yoneymaa have been discussed above and differ from the instantly claimed invention in that it is not taught that an immunosuppressive agent such as a steroid is further administered in the method of treating acquired hemophilia A in a subject.
However, Huth-Kühne teaches international recommendations for the treatment of acquired hemophilia A, including anti-hemorrhagic therapy for acute bleeding control and immunosuppressive therapy such as with corticosteroids for inhibitor eradication to reduce subsequent bleeding risk (see Abstract and Table 1).
It would have been obvious to one of ordinary skill in the art to further administer an immunosuppressive agent such as a corticosteroid in the method of treating acquired hemophilia A in a subject disclosed by Yoneyama comprising administering the bispecific antibody of the issued claims. One of ordinary skill in the art would have been motivated to do so since corticosteroids can be used to eradicate autoantibodies (or inhibitors) and reduce subsequent bleeding risk in a subject as taught by Huth-Kühne. Further, the bispecific anti-FIX/FX antibody can be considered a type of anti-hemorrhagic agent that functionally substitutes for coagulation FVIII. Thus, there is a reasonable expectation of success that acquired hemophilia A can be treated with a bispecific anti-FIX/FX antibody (anti-hemorrhagic agent) followed by a corticosteroid (immunosuppressant). Therefore, one of ordinary skill in the art would reasonably expect administering a bispecific anti-FIX/FX antibody of the issued claims followed by an immunosuppressant such as a corticosteroid can effectively treat acquired hemophilia A in a subject.
Claims 35-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12168697B2 in view of Yoneyama (US20170253663A1, of record).
The issued claims recite a method of treating acquired hemophilia A in a subject comprising administering a bispecific factor IX/X antibody having a first heavy chain of SEQ ID NO: 1 with a modified constant region, a second heavy chain of SEQ ID NO: 2 with a modified constant region, and a commonly shared light chain of SEQ ID NO: 3 with a modified constant region (issued claims 1 and 10). The bispecific antibody comprising a first heavy chain of SEQ ID NO: 1; a second heavy chain of SEQ ID NO: 2; and a commonly shared light chain of SEQ ID NO: 3 is Emicizumab (see Column 7, Ln. 24-35 of issued specification). According to para. 0018 of the instant specification, the first heavy chain of Emicizumab fully comprises the CDRs of SEQ ID NOs: 1, 2, and 3 as well as the VH chain of SEQ ID NO: 4 recited in the instant claims. The second heavy chain of Emicizumab fully comprises the CDRs of SEQ ID NOs: 6, 7, 8 as well as the VH chain of SEQ ID NO: 9 recited in the instant claims. The commonly shared light chain of Emicizumab fully comprises the CDRs of SEQ ID NOs: 11, 12, and 13 as well as the VL chain of SEQ ID NO: 14 recited in the instant claims. Since the issued claims only recite modifications in the constant regions, the bispecific anti-FIX/FX antibody of issued claim 1 reads on the bispecific FIX/FX antibodies recited in instant claims 35-40 which only recite the CDRs or VH/VL regions.
The issued claims do not recite that the bispecific anti-FIX/FX antibody is administered according to the specific dosage amounts and regimens recited in the instant claims.
However, Yoneyama teaches a method of preventing and/or treating a subject having acquired hemophilia A comprising (a) administering to the subject an initial dose of approximately 0.001 to 100 mg/kg of a bispecific anti-FIX/FX antibody that functionally substitutes for coagulation factor VIII; and (b) administering two or more continued doses of the bispecific anti-FIX/FX antibody to the subject, wherein the time interval between consecutive administrations of the doses is one day or longer, and the amount of the bispecific anti-FIX/FX antibody in each continued dose is approximately the same as, or is less than, the amount in the initial dose (Abstract, Summary of the Invention, Para. 0066, Para. 0067-0070, Para. 0073-0074, Claim 16, and Claims 28-29). Treatment of hemophilia refers to, for example, reducing the bleeding frequency by administering the composition to a patient who had shown bleeding to prevent manifestation of bleeding symptoms in advance (prevention of bleeding) (Para. 0081); as such, prevention of bleeding necessarily encompasses prophylactic administration. An initial dose in the range of 0.001 to 100 mg/kg that is administered can be, for example, 6 mg/kg (Para. 0066). Each continued dose can be nearly the same as or less than the initial dose such as approximately one-half, one-third, or one-fourth of the initial dose and so on (Para. 0067). For example, if the initial dose is 6 mg/kg, then a continued dose that is the same as the initial dose would be 6 mg/kg. A continued dose that is one-half the initial dose would be 3 mg/kg. A continued dose that is one-fourth the initial dose would be 1.5 mg/kg. The number of times the continued dose is continually administered is not particularly limited, and the number is for example once, twice, three times, four times, and so on (Para. 0072). An administration interval of one day or longer can include for example 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 4 weeks and so on (Para. 0073). The administration interval between each dose can be the same or vary and be longer or shorter in duration (Para. 0074). Further, it is stated that the dosage regimen for a hemophilia A patient can be determined by considering the effects of preventing bleeding in patients and clinically acceptable safety (Para. 0079).
It would have been obvious to one of ordinary skill in the art to modify the method of the issued claims such that the bispecific anti-FIX/FX antibody is administered according to dosage amounts and administration intervals outlined by Yoneyama, wherein each dose is administered subcutaneously and each dose is a single administration. One of ordinary skill in the art would have been motivated to do so in order to effectively treat acquired hemophilia A in a subject. Further, the courts have stated "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); thus, it would have been prima facie obvious to one of ordinary skill in the art to determine by routine experimentation the optimum dosage amounts and dosing regimens for the bispecific antibody Emicizumab to arrive at different embodiments of the instantly claimed invention. Therefore, one of ordinary skill in the art would expect that the bispecific anti-FIX/FX antibody of the issued claims can effectively treat acquired hemophilia A in a subject according to optimized dosage amounts and regimens recited in the instant claims determined by routine experimentation.
Claims 1-22 and 25-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8, 11-13, and 34-53 of U.S. Patent No. 12460014B2 in view of Yoneyama (US20170253663A1, of record).
The issued claims recite a method for treating acquired hemophilia A in a patient comprising administering an antibody formulation containing the bispecific anti-FIX/FX antibody Emicizumab (issued claims 9 and 16). Per para. 0018 of the instant specification, Emicizumab comprises a first heavy chain having the CDRs of SEQ ID NOs: 1, 2, and 3 as well as the VH chain of SEQ ID NO: 4 recited in the instant claims; a second heavy chain having the CDRs of SEQ ID NOs: 6, 7, 8 as well as the VH chain of SEQ ID NO: 9 recited in the instant claims; and a commonly shared light chain having the CDRs of SEQ ID NOs: 11, 12, and 13 as well as the VL chain of SEQ ID NO: 14 recited in the instant claims.
The issued claims do not recite that the bispecific anti-FIX/FX antibody is administered according to the specific dosage amounts and regimens recited in the instant claims, wherein each dose is administered subcutaneously and provided as a single administration.
However, Yoneyama teaches a method of preventing and/or treating a subject having acquired hemophilia A comprising (a) administering to the subject an initial dose of approximately 0.001 to 100 mg/kg of a bispecific antigen-binding molecule that recognizes both (i) coagulation factor IX and/or activated blood coagulation factor IX, and (ii) blood coagulation factor X and/or activated blood coagulation factor X and functionally substitutes for coagulation factor VIII; and (b) administering two or more continued doses of the bispecific antigen-binding molecule to the subject, wherein the time interval between consecutive administrations of the doses is one day or longer, and the amount of the bispecific antigen-binding molecule in each continued dose is approximately the same as, or is less than, the amount in the initial dose (Abstract, Summary of the Invention, Para. 0066, Para. 0067-0070, Para. 0073-0074, Claim 16, and Claims 28-29). Treatment of hemophilia refers to, for example, reducing the bleeding frequency by administering the composition to a patient who had shown bleeding to prevent manifestation of bleeding symptoms in advance (prevention of bleeding) (Para. 0081); as such, prevention of bleeding necessarily encompasses prophylactic administration. Each dose of the bispecific antibody is administered subcutaneously (Claim 34), and each dose is necessarily administered as a single administration. An initial dose in the range of 0.001 to 100 mg/kg that is administered can be, for example, 6 mg/kg (Para. 0066). Each continued dose can be nearly the same as or less than the initial dose such as approximately one-half, one-third, or one-fourth of the initial dose and so on (Para. 0067). For example, if the initial dose is 6 mg/kg, then a continued dose that is the same as the initial dose would be 6 mg/kg. A continued dose that is one-half the initial dose would be 3 mg/kg. A continued dose that is one-fourth the initial dose would be 1.5 mg/kg. The number of times the continued dose is continually administered is not particularly limited, and the number is for example once, twice, three times, four times, and so on (Para. 0072). An administration interval of one day or longer can include for example 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 4 weeks and so on (Para. 0073). The administration interval between each dose can be the same or vary and be longer or shorter in duration (Para. 0074). Further, it is stated that the dosage regimen for a hemophilia A patient can be determined by considering the effects of preventing bleeding in patients and clinically acceptable safety (Para. 0079).
It would have been obvious to one of ordinary skill in the art to use the bispecific anti-FIX/FX antibody (Emicizumab) of the issued claims in the method of treating acquired hemophilia A in a subject according to the dosage amounts and administration intervals as outlined Yoneyama, wherein each dose is administered subcutaneously and each dose is a single administration. One of ordinary skill in the art would have been motivated to do so in order to treat acquired hemophilia A in a subject. Further, the courts have stated "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); thus, it would have been prima facie obvious to one of ordinary skill in the art to determine by routine experimentation the optimum dosage amounts and dosing regimens for the bispecific antibody Emicizumab to arrive at different embodiments of the instantly claimed invention. Therefore, one of ordinary skill in the art would expect that the bispecific anti-FIX/FX antibody of the issued claims can be effectively treat acquired hemophilia A in a subject according to optimized dosage amounts and regimens determined by routine experimentation.
Claims 23 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8, 11-13, and 34-53 of co-pending Application No. 16/093,495 in view of Yoneyama, as applied to claims 1-22 and 25-52 above, and further in view of Huth-Kuhne et al (Huth-Kühne, Angela, et al. "International recommendations on the diagnosis and treatment of patients with acquired hemophilia A." haematologica 94.4 (2009): 566, of record), hereinafter Huth-Kühne.
This is a provisional non-statutory double patenting rejection.
The teachings of the co-pending claims in view of Yoneymaa have been discussed above and differ from the instantly claimed invention in that it is not taught that an immunosuppressive agent such as a steroid is further administered in the method of treating acquired hemophilia A in a subject.
However, Huth-Kühne teaches international recommendations for the treatment of acquired hemophilia A, including anti-hemorrhagic therapy for acute bleeding control and immunosuppressive therapy such as with corticosteroids for inhibitor eradication to reduce subsequent bleeding risk (see Abstract and Table 1).
It would have been obvious to one of ordinary skill in the art to further administer an immunosuppressive agent such as a corticosteroid in the method of treating acquired hemophilia A in a subject as taught by the co-pending claims in view Yoneyama. One of ordinary skill in the art would have been motivated to do so since corticosteroids can be used to eradicate autoantibodies (or inhibitors) and reduce subsequent bleeding risk in a subject as taught by Huth-Kühne. Further, the bispecific anti-FIX/FX antibody can be considered a type of anti-hemorrhagic agent that functionally substitutes for coagulation FVIII. Thus, there is a reasonable expectation of success that acquired hemophilia A can be treated with a bispecific anti-FIX/FX antibody (anti-hemorrhagic agent) followed by a corticosteroid (immunosuppressant). Therefore, one of ordinary skill in the art would reasonably expect administering a bispecific anti-FIX/FX antibody of the issued claims followed by an immunosuppressant such as a corticosteroid can effectively treat acquired hemophilia A in a subject.
Claims 1-22 and 25-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of co-pending Application No. 19017875 in view of Yoneyama (US20170253663A1, of record).
This is a provisional non-statutory double patenting rejection.
The co-pending the bispecific anti-FIX/FX antibody Q499-z121/J327-z119/L404-k (or Emicizumab per para. 0018 of the instant specification) (co-pending claims 36 and 43). Per para. 0018 of the instant specification, Emicizumab comprises a first heavy chain having the CDRs of SEQ ID NOs: 1, 2, and 3 as well as the VH chain of SEQ ID NO: 4 recited in the instant claims; a second heavy chain having the CDRs of SEQ ID NOs: 6, 7, 8 as well as the VH chain of SEQ ID NO: 9 recited in the instant claims; and a commonly shared light chain having the CDRs of SEQ ID NOs: 11, 12, and 13 as well as the VL chain of SEQ ID NO: 14 recited in the instant claims.
The co-pending claims do not recite that the bispecific anti-FIX/FX antibody is administered according to the specific dosage amounts and regimens recited in the instant claims, wherein each dose is administered subcutaneously and provided as a single administration.
However, Yoneyama teaches a method of preventing and/or treating a subject having acquired hemophilia A comprising (a) administering to the subject an initial dose of approximately 0.001 to 100 mg/kg of a bispecific antigen-binding molecule that recognizes both (i) coagulation factor IX and/or activated blood coagulation factor IX, and (ii) blood coagulation factor X and/or activated blood coagulation factor X and functionally substitutes for coagulation factor VIII; and (b) administering two or more continued doses of the bispecific antigen-binding molecule to the subject, wherein the time interval between consecutive administrations of the doses is one day or longer, and the amount of the bispecific antigen-binding molecule in each continued dose is approximately the same as, or is less than, the amount in the initial dose (Abstract, Summary of the Invention, Para. 0066, Para. 0067-0070, Para. 0073-0074, Claim 16, and Claims 28-29). Treatment of hemophilia refers to, for example, reducing the bleeding frequency by administering the composition to a patient who had shown bleeding to prevent manifestation of bleeding symptoms in advance (prevention of bleeding) (Para. 0081); as such, prevention of bleeding necessarily encompasses prophylactic administration. Each dose of the bispecific antibody is administered subcutaneously (Claim 34), and each dose is necessarily administered as a single administration. An initial dose in the range of 0.001 to 100 mg/kg that is administered can be, for example, 6 mg/kg (Para. 0066). Each continued dose can be nearly the same as or less than the initial dose such as approximately one-half, one-third, or one-fourth of the initial dose and so on (Para. 0067). For example, if the initial dose is 6 mg/kg, then a continued dose that is the same as the initial dose would be 6 mg/kg. A continued dose that is one-half the initial dose would be 3 mg/kg. A continued dose that is one-fourth the initial dose would be 1.5 mg/kg. The number of times the continued dose is continually administered is not particularly limited, and the number is for example once, twice, three times, four times, and so on (Para. 0072). An administration interval of one day or longer can include for example 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 4 weeks and so on (Para. 0073). The administration interval between each dose can be the same or vary and be longer or shorter in duration (Para. 0074). Further, it is stated that the dosage regimen for a hemophilia A patient can be determined by considering the effects of preventing bleeding in patients and clinically acceptable safety (Para. 0079).
It would have been obvious to one of ordinary skill in the art to use the bispecific anti-FIX/FX antibody (Emicizumab) of the co-pending claims in the method of treating acquired hemophilia A in a subject according to the dosage amounts and administration intervals as outlined Yoneyama, wherein each dose is administered subcutaneously and each dose is a single administration. One of ordinary skill in the art would have been motivated to do so in order to treat acquired hemophilia A in a subject. Further, the courts have stated "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); thus, it would have been prima facie obvious to one of ordinary skill in the art to determine by routine experimentation the optimum dosage amounts and dosing regimens for the bispecific antibody Emicizumab to arrive at different embodiments of the instantly claimed invention. Therefore, one of ordinary skill in the art would expect that the bispecific anti-FIX/FX antibody of the co-pending claims can be effectively treat acquired hemophilia A in a subject according to the optimized dosage amounts and regimens determined by routine experimentation.
Claims 23 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of co-pending Application No. 19017875 in view of Yoneyama, as applied to claims 1-22 and 25-52 above, and further in view of Huth-Kuhne et al (Huth-Kühne, Angela, et al. "International recommendations on the diagnosis and treatment of patients with acquired hemophilia A." haematologica 94.4 (2009): 566, of record), hereinafter Huth-Kühne.
This is a provisional non-statutory double patenting rejection.
The teachings of the co-pending claims in view of Yoneymaa have been discussed above and differ from the instantly claimed invention in that it is not taught that an immunosuppressive agent such as a steroid is further administered in the method of treating acquired hemophilia A in a subject.
However, Huth-Kühne teaches international recommendations for the treatment of acquired hemophilia A, including anti-hemorrhagic therapy for acute bleeding control and immunosuppressive therapy such as with corticosteroids for inhibitor eradication to reduce subsequent bleeding risk (see Abstract and Table 1).
It would have been obvious to one of ordinary skill in the art to further administer an immunosuppressive agent such as a corticosteroid in the method of treating acquired hemophilia A in a subject as taught by the co-pending claims in view Yoneyama. One of ordinary skill in the art would have been motivated to do so since corticosteroids can be used to eradicate autoantibodies (or inhibitors) and reduce subsequent bleeding risk in a subject as taught by Huth-Kühne. Further, the bispecific anti-FIX/FX antibody can be considered a type of anti-hemorrhagic agent that functionally substitutes for coagulation FVIII. Thus, there is a reasonable expectation of success that acquired hemophilia A can be treated with a bispecific anti-FIX/FX antibody (anti-hemorrhagic agent) followed by a corticosteroid (immunosuppressant). Therefore, one of ordinary skill in the art would reasonably expect administering a bispecific anti-FIX/FX antibody of the issued claims followed by an immunosuppressant such as a corticosteroid can effectively treat acquired hemophilia A in a subject.
Response to Arguments
Applicant's arguments filed 10/24/2025 have been fully considered but they are not persuasive.
With respect to the rejections made under 35 USC 103, Applicant argues that 1) Yoneyama discloses a wide variety of possible dosages and timing, but provides no reason to select the particular dosage regimens as presently claimed; and 2) the teachings of Yoneyama do not address the particular problem addressed by the present inventors: i.e. how to minimize the time it takes to achieve an effective therapeutic dose of plasma Emicizumab in patients with acquired hemophilia A (AHA), who generally have more severe bleeding events and higher risk of bleeding during early stages compared to patients with congenital hemophilia. In particular, the inventors made a population pharmacokinetic model using plasma Emicizumab concentration data of patients with congenital hemophilia A was used to simulate time courses of plasma Emicizumab concentration of patients with AHA. The predicted median plasma Emicizumab trough levels were 11.6 and 37.8 ug/mL, respectively, after 1 week (Day 8) and 4 weeks (Day 29) using the standard administration schedule for Emicizumab (Loading dose: 3 mg/kg weekly for 4 weeks; Maintenance dose: 1.5 mg/kg weekly, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks). However, predicted median Emicizumab trough levels were 34.6 and 36.9 ug/mL, respectively after Week 1 and Week 4 using the accelerated loading dose schedule of the claimed invention (i.e. 6 mg/kg on Day 1, 3 mg/kg on Day 2, followed by weekly intervals of 1.5 mg/kg beginning on Day 8). Thus, Applicant asserts that with the claimed daily loading + 1 week interval maintenance administration regimen of the present disclosure, it is predicted that the plasma Emicizumab concentration will exceed the estimated effective concentration of 30 ug/mL in most patients by 1 week after the start of administration (Day 8), and that the plasma Emicizumab concentration trough level will reach steady state by 2 weeks after the start of administration (Day 15). As such, the accelerated schedule shortens the time to achieve a concentration of Emicizumab in plasma effective to prevent bleeding in patients with AHA.
In response to Applicant’s arguments, the Examiner notes that Yoneyama expressly teaches 1) an initial dose range antibody of 0.001 to 100 mg/kg for a bispecific anti-FIX/FX, with 6 mg/kg explicitly listed as an exemplary dose; 2) subsequent doses administered at the same dose, one-half the dose, one-quarter the dose, and so on; and 3) dosing intervals of at least one day, including 1 day, 2 days, 1 week, and longer intervals. Thus, each element of the claimed dosing regimen is either explicitly disclosed or directly suggested by the prior art. Yoneymama further teaches that the dosage regimen for a hemophilia A patient can be determined by considering the effects of preventing bleeding in patients and clinically acceptable safety (Para. 0079). As such, the dose amount and dosing interval are result-effective variables to be optimized by a person of ordinary skill in the art. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144). In this case, adjusting the initial dose, the amount of subsequent doses, and the interval between doses to achieve therapeutic levels at an earlier time point is routine using techniques well-known in the art. For example, population pharmacokinetic (popPK) modeling is a quantitative tool routinely used to describe the time course of drug exposure in patients and to investigate sources of variability in patient exposure. Using PopPK models, alternative dosing regimens can be simulated to provide informed assessment of dose regimens before a study is conducted (Mould et al, Abstract and Background). Further, increasing the dose or shortening the dosing interval is a strategy that is generally expected to increase the magnitude of the stead-state concentration of a drug (Chen, see “Dose” and “Dosing Interval” sections). Hence, the ability of the accelerated dosing regimen to shorten the time to achieve a concentration of Emicizumab in plasma effective to prevent bleeding in patients with AHA is not unexpected. Therefore, the teachings of the prior art render obvious the claimed dosing regimen for Emicizumab, which can be achieved by routine optimization using techniques well within the skill of ordinary artisans.
With respect to double patenting rejections, Applicant sets forth the same arguments regarding non-obviousness of the claimed invention. In view of the above, however, the double patenting rejections are maintained for the reasons previously discussed.
Conclusion
No claims are allowed.
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.
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/LIA E TAYLOR/Examiner, Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641