Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group II (i.e., claims 13-21 and 43-47) and Species A (i.e., Seq ID Nos. 3 and 4) in the reply filed on 25 June 2025 is acknowledged.
Status of the Claims
Claims 1-47 were originally filed 7 January 2022 and the preliminary amendment filed the same day has been entered. Claims 1-12 and 22-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected non-elected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 25 June 2025. Claims 13-21 and 43-47 are currently pending and under consideration.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13 recites, “pharmaceutical acceptable carrier” in line 3 and should recite, “pharmaceutically acceptable carrier” .
Appropriate correction is required.
Withdrawn Rejections
In view of Applicant’s amendments to claims 13, 43, and 45 to eliminate language directed to particular CDRs the 35 USC 112(b) rejection of claims 13-21 and 43-47 is hereby withdrawn.
In view of Applicant amending claims 43 and 45 to require either Seq ID No: 3 or 4 in its entirety the prior art rejections and non-statutory double patenting rejections over these claims are hereby withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-21 and 43-47 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for humanized anti-DKK2 antibodies comprising either i. amino acid sequences comprising Seq ID Nos: 3 and 4 or ii. encoded by nucleic acid sequences comprising Seq ID Nos: 1 and 2, does not reasonably provide enablement for humanized anti-DKK2 antibodies comprising i. a. either amino acid sequence comprising Seq ID No: 3 or 4, or b. encoded by either nucleic acid sequence comprising Seq ID Nos: 1 or 2. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Applicant's arguments filed 25 February 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues the amendments overcome the rejection (see Remarks pg. 1, 2nd section) Applicant has amended the claims 13, 14, and 43-46 to recite wherein the antibody or nucleic acid sequence encoding said antibody comprises either:
“at least one of the amino acid sequences selected from the group consisting of Seq ID Nos: 3 or 4” (see claims 13, 43, and 45) or
“”is encoded by at least one of the nucleic acid sequences selected from the group consisting of Seq ID Nos: 1 and 2” (see claims 14, 44, and 46).
Applicant’s amendments encompass antibodies or nucleic acids encoding said antibodies wherein a claimed VH is paired with any VL, or a claimed VL is paired with any VH. Therefore, the 35 USC 112(a) rejection of claims 13-21 and 43-47 is maintained for the reasons made of record.
Maintained 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13 and 15-21, are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO2017/074774 A1 (as cited on the IDS dated 05/12/2022, referred to herein as Wu) published 4 May 2017 as evidenced by Culang (see Culang et al. (2013) The structural basis of antibody-antigen recognition. Front. In Immun. 2013. Vol. 4, Article 302, pgs. 1-13).
Claims 13 and 15-21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2018/174984 A1 (as cited on the IDS dated 05/12/2022, referred to herein as Xiao) published 19 July 2018 as evidenced by Culang (see Culang et al. (2013) The structural basis of antibody-antigen recognition. Front. In Immun. 2013. Vol. 4, Article 302, pgs. 1-13).
Claims 13 and 15-21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent Publication 2018/0200354 A1 (as cited on the IDS dated 05/12/2022, referred to herein as Sun) published 19 July 2018 as evidenced by Culang (see Culang et al. (2013) The structural basis of antibody-antigen recognition. Front. In Immun. 2013. Vol. 4, Article 302, pgs. 1-13).
Applicant's arguments filed 25 February 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues the prior art fails disclose each element of the amended claims, specifically an either Seq ID Nos: 3 or 4 (see Remarks pg. 13 bottom).
Claim 13 is drawn to a pharmaceutical composition comprising either a humanized anti-DKK2 antibody or a fragment thereof. The scope of claim 13 encompasses compositions comprising antibodies with a single CDR from either Seq ID Nos: 3 or 4 (i.e. a fragment thereof). Given each of the prior art rejections anticipates anti-Dkk2 antibodies with 6 identical CDRS from Seq ID Nos: 3 and 4 the prior art rejections above are hereby maintained.
Examiner suggests amending claim 13 to recite the following:
“A pharmaceutical composition for treating a cancer in a subject, the pharmaceutical composition comprising a humanized anti-DKK2 antibody or fragment thereof and a pharmaceutically acceptable carrier, wherein the humanized anti-DKK2 antibody or fragment thereof comprises…”
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 13 and 15-21, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-19 and 27-29 of U.S. Patent No. 10,398,765 B2 (referred to herein as ‘765 patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 13 and 15-21, 43, 45, and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 11,497,799 B2 (referred to herein as ‘799 patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 13 and 15-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,267,875 B2 (referred to herein as ‘875 patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Applicant's arguments filed 25 February 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues the prior art fails disclose each element of the amended claims, specifically an either Seq ID Nos: 3 or 4 (see Remarks pg. 14, 3rd and last full para, pg. 15, 3rd para).
Claim 13 is drawn to a pharmaceutical composition comprising either a humanized anti-DKK2 antibody or a fragment thereof. The scope of claim 13 encompasses antibodies with a single CDR from either Seq ID Nos: 3 or 4 (i.e., fragment thereof). Given each of the prior art rejections anticipates anti-Dkk2 antibodies with 6 identical CDRS from Seq ID Nos: 3 and 4 the prior art rejections above are hereby maintained.
Examiner suggests amending claim 13 to recite the following:
“A pharmaceutical composition for treating a cancer in a subject, the pharmaceutical composition comprising a humanized anti-DKK2 antibody or fragment thereof and a pharmaceutically acceptable carrier, wherein the humanized anti-DKK2 antibody or fragment thereof comprises…”
Conclusion
No claims 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 HILARY ANN PETRASH whose telephone number is (703)756-4630. The examiner can normally be reached Monday-Friday 8:30-4:30 EST.
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/H.A.P./ Examiner, Art Unit 1644
/AMY E JUEDES/ Primary Examiner, Art Unit 1644
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