Prosecution Insights
Last updated: October 23, 2026
Application No. 18/535,068

FORMULATIONS OF HUMAN ANTI-RANKL ANTIBODIES, AND METHODS OF USING THE SAME

Final Rejection §103§DOUBLEPATENT
Filed
Dec 11, 2023
Priority
Apr 28, 2017 — provisional 62/492,056 +3 more
Examiner
LANDSMAN, ROBERT S
Art Unit
1647
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Amgen Inc.
OA Round
2 (Final)
81%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allowance Rate
1039 granted / 1277 resolved
+21.4% vs TC avg
Moderate +13% lift
Without
With
+13.0%
Interview Lift
resolved cases with interview
Fast prosecutor
2y 2m
Avg Prosecution
65 currently pending
Career history
1322
Total Applications
across all art units

Statute-Specific Performance

§101
3.6%
-36.4% vs TC avg
§103
19.4%
-20.6% vs TC avg
§102
13.4%
-26.6% vs TC avg
§112
40.3%
+0.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1277 resolved cases

Office Action

§103 §DOUBLEPATENT
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 . 1. Formal Matters Claims 1, 18, 47, 50, 52, 53, 56, 57, 59, 61, 63, 64, 66, 69, 71, 74, 76, 79 and 209-212 are pending and are the subject of this Office Action. 2. Claim Objections The objection to claim 1 has been withdrawn in view of Applicants’ amendment. 3. Claim Rejections - 35 USC § 103 All rejections have been withdrawn in view of Applicants’ amendment to claim 1 in view of their arguments. 4. Nonstatutory 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. The claims remain rejected over U.S. Patent 11,192,952 and 11,873,343 for the reasons of record on pages 5-7 of the Office Action dated 3/18/26. New claims 211 and 212 are also rejected. The rejections are being held in abeyance. 5. Conclusion No claim is allowable. 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 extension fee 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. Advisory information Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is (571)272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern). 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, Joanne Hama, can be reached at (571)272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
Read full office action

Prosecution Timeline

Dec 11, 2023
Application Filed
Jul 24, 2024
Response after Non-Final Action
Mar 18, 2026
Non-Final Rejection mailed — §103, §DOUBLEPATENT
Sep 17, 2026
Response Filed
Oct 05, 2026
Final Rejection mailed — §103, §DOUBLEPATENT (current)

Precedent Cases

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
81%
Grant Probability
94%
With Interview (+13.0%)
2y 2m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 1277 resolved cases by this examiner. Grant probability derived from career allowance rate.

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