DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment, filed 04/30/2026, has been entered.
Claims 1, 2, 9, 16-22, 24-25, 27-28, 30, 33, 39, 77 are pending.
Claim 77 has been withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1, 2, 9, 16-22, 24-25, 27-28, 30, 33, 39 are currently under examination as they read on a method of treating ARDS comprising administering an inhibitor of the contact activation pathway that is an anti-pKal antibody.
This Office Action will be in response to Applicant’s arguments/remarks, filed 04/30/2026.
The Rejections of Record can be found in the previous Office Action, mailed 12/31/2026.
The previous Indefinite rejection under 35 U.S.C. 112(b) has been withdrawn in view of Applicant’s amendment, filed 04/30/2026.
The previous Written Description rejection under 35 U.S.C. 112(a) has been withdrawn in view of Applicant’s amendment, filed 04/30/2026.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 16-19, 28, 30, 33, 39 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sexton et al. (US 2015/0362493 A1; see entire document).
The previous rejection under 35USC102(a)(2) has been withdrawn pursuant to exception under 35 USC 102(b)(2)(c). However, the rejection under 35USC 102(a)(1) is maintained for reasons of record. The rejection of record can be found in the previous Office Action, mailed 12/31/2025.
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.
Claims 2, 9, 20, 21, are rejected under 35 U.S.C. 103 as being obvious over Sexton et al. (US 2015/0362493 A1) in view of Luyt et al. (Presse Med. 2011;40(12 Pt 2):e561-e568) and Adelman et al. (US 2018/0362664 A1).
Applicant’s argument has been considered but has not been found convincing for reasons of record. The rejection of record can be found in the previous Office Action, mailed 12/31/2025.
Foremost, with respect to the availability of Sexton as prior art, it is noted that Sexton is still available as prior art under 35 USC 102(a)(1). Sexton taught treating ARDS using the same anti-pKal antibody. The deficiencies of Sexton are that 1) ARDS is associated with respiratory viral infection and 2) the recited pharmaceutical composition. These deficiencies were cured by the teachings of Luyt and Adelman as discussed in the rejection of record. Therefore, the combined teachings of Sexton, Luyt and Adelman render obvious of the present claims.
Therefore, the rejection is 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, 2, 9, 16-22, 24-25, 27-28, 30, 33, 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following in view of Sexton et al. (US 2015/0362493 A1), Luyt et al. (Presse Med. 2011;40(12 Pt 2):e561-e568) and Adelman et al. (US 2018/0362664 A1).
US Patent
Claims
10648990
1-10
11084884
1-17
11156612
9-11
11340237
1-7
11372002
1-15
11892450
1-20
8816055
1-7
8822653
1-32
9266964
1-6
10336832
1-7
10428158
1-9
11046785
1-7
11286307
1-19
11299553
1-16
11505620
1-20
12084515
1-10
12110343
1-10
The claims of the above-mentioned patents disclosed the same antibody DX-2930 and/or a method of treating a disease comprising administering the antibody. Although the claims did not teach treating ARDS, it would have been obvious to use DX-2930 to treat ARDS given the teachings of Sexton et al. as discussed above in 102. Furthermore, it would have been obvious to treat patients of ARDS having association with a viral infection as taught by Luyt et al. as discussed above in 103. Lastly, it would have been obvious to arrive at the pharmaceutical composition comprising the recited components in view of the teaching by Adelman and the recited dosage and frequency as they are result effective variables as discussed above in 103. Therefore, the patent claims would render obvious of the present claims in view of Sexton, Luyt and Adelman.
Applicant’s argument and Examiner’s response are essentially same as above. Therefore, the rejection is maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/SHARON X WEN/ Primary Examiner, Art Unit 1641
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