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 .
Claim Status
Claims 2-4, 8, 11, 14-15, 17, 22, 25-26, 28-29, 30-33 and 37-39 were canceled.
Claims 1, 5-7, 9-10, 12-13, 16, 18-21, 23-24, 27 and 34-36 are pending and under consideration.
Withdrawn Rejections
Objection of specification is withdrawn. Applicant amended the specification, thereby obviating this objection.
Objection of claim 21 is withdrawn. Applicant amended the claim 21, thereby obviating this rejection/objection.
Rejection of Claims 1, 5-7, 12, 18-21, 27, 29, 35 and 38 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn. Applicant amended the claims, thereby obviating this rejection/objection.
Rejection of Claims 1, 5-7, 9-10, 12-13, 16, 18-21, 23-24, 27, 29, and 34-39 under 35 U.S.C. 103 as being unpatentable over Bedian et al (WO2022/165130) in view of Chyung et al (WO2015/112578) is withdrawn. Applicant provided a persuasive argument “Even if one of ordinary skill in the art had been motivated to investigate longer dosing intervals, nothing in either Bedian or Chyung teaches that the specific dosing regimen now claimed would maintain serum concentrations above the claimed threshold while simultaneously producing the dramatic reductions in HAE attack frequency or duration required by the claims.” (Applicant’s response, 7/27/2026, page 13).
MAINTAINED - 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, 5-7, 9-10, 12-13, 16, 18-21, 23-24, 27 and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-251 of copending Application No. 19/134,598 (hereinafter application’598). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 1, 9, 18, 23-24, 27 and 34-36, claim 1 of application’598 claims “A method of treating a human subject having a plasma kallikrein associated disorder, comprising: administering a loading dose of 600-900 mg of an anti-plasma kallikrein antibody to the subject; and administering a maintenance dose of 150-450 mg of the anti-plasma kallikrein antibody to the subject beginning at least about 2 months after administering the loading dose and then at least about every 2 months thereafter; wherein the anti-plasma kallikrein antibody comprises: … iii) an immunoglobulin heavy chain comprising the amino acid sequence of SEQ ID NO:9 and a light chain comprising the amino acid sequence of SEQ ID NO: 10.” SEQ ID NO: 9 and 10 of application’598 is 100% identical to instant SEQ ID NO: 9 and 10, respectively (see SCV; result 1 of 9.rapm; result 1 of 10.rapm). Therefore, the antibody of application’598 is the same antibody with same sequence as instant claims. Claim 16 of application’598 claims that the loading dose is 600 mg. Claim 27 of application’598 claims that the maintenance dose is 300 mg. Claim 43 of application’598 claims that the maintenance dose is administered about three months after administering the loading dose and then about every three months thereafter. Therefore, application’598 claims same dosing regimen as instant claim 1.
The limitation “reducing a monthly hereditary angioedema (HAE) attack rate experienced by a subject with HAE” and “wherein treating the subject with the anti-plasma kallikrein antibody according to the dosing regimen reduces the subject's monthly HAE attack rate by at least 85% for at least 3 months from initiation of the dosing regimen relative to the-subject's baseline monthly HAE attack rate prior to initiation of the dosing regimen” of instant claim 1 is expected result. Because application’598 claims same active process step using same antibody with same sequence as instant claims, the claims of application’598 will have same expected result as instant claims. Claim 130 of application’598 claims that the first dose, second dose, and any one or more subsequent doses are administered to the subject subcutaneously.
Regarding claims 9, 18 and 23-24, wherein-clause of these claims describe different expected result, but claims same active process step as instant claim 1. As application’598 claims same active process step as instant claims, application’598 claims same claim as instant claims.
Regarding claims 5-7, 10, 12-13, 16, and 19-21, these claims describe expected result of the active process step (i.e. administering anti-plasma kallikrein antibody). As discussed above, because application’598 claims same active process step using same antibody with same sequence as instant claims, the claims of application’598 will have same expected result as instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
In the response filed on 7/27/2026, Applicant argued at page 14,
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Applicant's arguments have been fully considered but they are not persuasive. Because same dosing regimen with same antibody will have same result, instant claims are not patentably distinct from claims of application’598.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 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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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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