Prosecution Insights
Last updated: October 04, 2026
Application No. 18/023,913

ROR1-TARGETING ANTIBODY OR ANTIGEN-BINDING FRAGMENT THEREOF, PREPARATION METHOD THEREFOR, AND APPLICATION THEREOF

Non-Final OA §112
Filed
Feb 28, 2023
Priority
Sep 03, 2020 — CN 202010918328.7 +1 more
Examiner
BERHANE, SELAM
Art Unit
1675
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Harbour BioMed (Shanghai) Co., Ltd.
OA Round
2 (Non-Final)
58%
Grant Probability
Moderate
2-3
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
52 granted / 89 resolved
-1.6% vs TC avg
Strong +57% interview lift
Without
With
+56.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
45 currently pending
Career history
146
Total Applications
across all art units

Statute-Specific Performance

§101
2.6%
-37.4% vs TC avg
§103
27.4%
-12.6% vs TC avg
§102
14.5%
-25.5% vs TC avg
§112
43.8%
+3.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 89 resolved cases

Office Action

§112
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 . DETAILED ACTION Election/Restrictions Applicant's election with traverse of Group I, claims 1, 4-5,8-12, 14-15, 17, 20, 22, and 25 and species: SEQ ID NOs: 12, 33, 53, 69, 78, 84, 95, 119, 138, 160, M substituted t position 6 of SEQ ID NO: 69, K substituted into position 4 of SEQ ID NO: 84, L substituted into position 5 of SEQ ID NO: 84, T substituted into position 6 of SEQ ID NO: 12, F substituted into position 7 of SEQ ID NO: 12, I substituted into position 5 of SEQ ID NO: 33, S substituted into position 6 of SEQ ID NO: 33, a ROR1-targeted antibody or antigen-binding fragment, a method for diagnosis, preventing, or treating a cancer, lung cancer, and macromolecular drug in the reply filed 11/19/2025 is acknowledged. Upon further consideration, the restriction requirement filed 09/24/2025 will be withdrawn as the claims have been amended to obviate the reference used to break unity. Claims 1, 4-5, 8-15, 17-20, and 22-27 are now under consideration in the instant Office Action. Claim Objections Claims 4, 18, and 25 are objected to because of the following informalities: instant claims 4 and 25 use the conjunction “or” too frequently. The terminology “or” is only needed between the penultimate and last claim limitations when semicolons are used. Instant claim 18 recites a method for detecting ROR1 in a sample. The claim contains incorrect grammar that renders the claim difficult to understand and requires revision. Appropriate correction is required. Claim Rejections - 35 USC § 112 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 27 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. Instant claim 27 recites parentheses for the terminology “anti-tumor” after “additional anti-cancer”. The terminology of “anti-tumor” does not acronymize the term which it follows, additional anti-cancer, and as such is an improper use of parenthetical references in a claim. It is unclear what Applicant means by encompassing the terminology in parentheses. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 19 and 23-24 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Instant claims 19 and 23-24 fail to further limit the claim from which they depend because they recite two known utilities of the claimed antibody: a therapeutic and a diagnostic process. The instant claims fail to provide new limitations which narrow the scope of the claim from which it depends. Additionally, the recitation of two methods in one claim does not further limit the uses or the structure of the antibody that is claimed. See MPEP 608.01(n) and Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92, 79 USPQ2d 1583, 1589-90 (Fed. Cir. 2006) for more. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5. 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, Jeffrey Stucker can be reached at 571-272-0911. 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. /SELAM BERHANE/Examiner, Art Unit 1675 /AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
Read full office action

Prosecution Timeline

Feb 28, 2023
Application Filed
Feb 18, 2026
Non-Final Rejection mailed — §112
May 15, 2026
Response Filed
Aug 05, 2026
Examiner Interview (Telephonic)
Aug 24, 2026
Non-Final Rejection mailed — §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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Patent 12559564
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5y 2m to grant Granted Feb 24, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

2-3
Expected OA Rounds
58%
Grant Probability
99%
With Interview (+56.7%)
3y 7m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 89 resolved cases by this examiner. Grant probability derived from career allowance rate.

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