Prosecution Insights
Last updated: October 04, 2026
Application No. 18/288,322

NON-CERULOPLASMIN BOUND COPPER LEVEL MONITORING

Final Rejection §103§112
Filed
Oct 25, 2023
Priority
Apr 26, 2021 — EU 21305537.9 +2 more
Examiner
DAVIS, BRIAN J
Art Unit
1614
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Orphalan S A
OA Round
2 (Final)
85%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
81%
With Interview

Examiner Intelligence

Grants 85% — above average
85%
Career Allowance Rate
1348 granted / 1589 resolved
+24.8% vs TC avg
Minimal -4% lift
Without
With
+-4.0%
Interview Lift
resolved cases with interview
Fast prosecutor
1y 9m
Avg Prosecution
46 currently pending
Career history
1625
Total Applications
across all art units

Statute-Specific Performance

§101
5.2%
-34.8% vs TC avg
§103
16.5%
-23.5% vs TC avg
§102
19.7%
-20.3% vs TC avg
§112
44.7%
+4.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1589 resolved cases

Office Action

§103 §112
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 . Claim Objections Withdrawn The objection to claim 4, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment corrects the claim text as appropriate. 112(b) Rejections Withdrawn The rejection of claim 16 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate. Claim Rejections - 35 USC § 112(b), NEW The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim 15 is rejected 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. The dependency of the claim is unclear because it depends from a canceled claim (claim 14). Clarification is in order. 103 Rejections Withdrawn The rejection of claims 1-4, 7-9 and 11-22 under 35 USC 103, outlined in the previous Office Action, has been overcome by inventor’s amendments and arguments. With respect to claims 3, 13, 14, 18 and 22, the amendment cancels the claims. With respect to the remaining claims, inventor’s narrowing amendments and accompanying arguments have been carefully considered and are persuasive. Allowable Subject Matter Claims 1, 2, 4, 7-9, 11, 12, 16, 17 and 19-21 are allowed. The subject matter of claim 15 would be allowable once the 112 rejection outlined above has been overcome. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art remains the prior art of record. As noted above, inventor has narrowed the scope of the claimed subject matter, and presented cogent accompanying arguments, that the instant methods would not have been obvious to one of ordinary skill with respect to accurately determining and appropriately controlling the non-ceruloplasmin bound copper levels in a subject undergoing treatment for Wilson’s Disease. There is no motivation to modify the teachings of the cited art in order to arrive at the instant methods. Conclusion 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 BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT. 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, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BRIAN J DAVIS/Primary Examiner, Art Unit 1614 8/21/2026
Read full office action

Prosecution Timeline

Oct 25, 2023
Application Filed
Feb 20, 2026
Non-Final Rejection mailed — §103, §112
May 20, 2026
Response Filed
Aug 25, 2026
Final Rejection mailed — §103, §112 (current)

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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
85%
Grant Probability
81%
With Interview (-4.0%)
1y 9m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 1589 resolved cases by this examiner. Grant probability derived from career allowance rate.

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