Prosecution Insights
Last updated: April 19, 2026
Application No. 18/264,819

ANTI-PD-L1 ANTIBODY AND USE THEREOF

Non-Final OA §112
Filed
Aug 09, 2023
Examiner
ALSOMAIRY, SARAH ABDOALATIF
Art Unit
1646
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Jiangxi Jemincare Group Co. Ltd.
OA Round
1 (Non-Final)
60%
Grant Probability
Moderate
1-2
OA Rounds
3y 3m
To Grant
85%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allow Rate
81 granted / 134 resolved
At TC average
Strong +25% interview lift
Without
With
+24.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
41 currently pending
Career history
175
Total Applications
across all art units

Statute-Specific Performance

§101
4.2%
-35.8% vs TC avg
§103
36.0%
-4.0% vs TC avg
§102
15.5%
-24.5% vs TC avg
§112
27.6%
-12.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 134 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 Claims 67-86 are currently pending and under prosecution. Priority Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application. 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 80-82 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 FILLIN "Identify claimed subject matter for which the specification is enabling" \* MERGEFORMAT alleviating or treating a tumor comprising administering the antibody or antibody fragment of claim 67 , does not reasonably provide enablement for preventing a tumor. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to FILLIN "Enter --make-- or --use-- or --make and use--" \* MERGEFORMAT practice the invention commensurate in scope with these claims. BREADTH OF CLAIMS : Claim 80 recites a method for preventing, alleviating or treating a tumor, comprising administering the antibody or antigen binding fragment of claim 67 to a subject in need, optionally the tumor includes a tumor with a high expression of PD-1 or PD-L1. STATE OF THE ART : A search of relevant art, does not reveal any demonstration that the combination of an sulfonamide inhibitor and an immune checkpoint inhibitor prevents cancer. Cancer has a wide variety of causes, from environmental and/or developmental exposure to ionizing radiation and/or chemical exposure in addition to some types viral and bacterial exposure (Lichtman MA et al. The Oncologist 2017; 22(5); 542–548). Even though cancer is featured by the infinite cell proliferation, its pathogenesis is extremely complex and related to many mechanisms. In general, the hallmarks of cancer consist of ten biological capabilities during the development of cancers, namely sustaining proliferative signaling, evading growth suppressors, resisting cell death, enabling replicative immortality, inducing angiogenesis, activating invasion and metastasis, tumor-promoting inflammation, genome instability and mutation, evading immune destruction and reprogramming energy metabolism (Hanahan D et al. Cell 2011 144(5) p646-674, Figures 1 and 3). More than 100 types of cancer have been identified which are typically termed for the organs or tissues where they occur. Hanahan taught over the past decade, tumors have increasingly been recognized as organs whose complexity approaches and may even exceed that of normal healthy tissues (page 661, right column second to last paragraph). Hanahan taught many human tumors are histopathologically diverse, containing regions demarcated by various degrees of differentiation, proliferation, vascularity, inflammation, and/or invasiveness (page 662, left column, first paragraph). Szabo et al (Selecting targets for cancer prevention: where do we go from here? Nat Rev Cancer 6, 867–874; 2006) teaches the intricacies and complications of cancer prevention. Szabo teaches that in addition to efficacy and toxicity concerns of cancer drugs targeting functions, there are a number of practical issues that should be considered, including drug formulation and dosing schedule to ensure adherence, as well as the cost. Szabo also teaches that in some cases the targets selected for drug therapy may even cause harm. [Whole document] Clinical trials aimed at proving preventative cancer activity attributable to a specific intervention are largely infeasible, due to the impossibly large number of subjects and an equally impossible long timeframe. Although cancer is a common disease, specific types of cancer are still relatively infrequent events in an otherwise healthy population. Therefore, trials with cancer incidence as endpoints would necessarily involve several thousands of subjects followed for several decades. Such logistic difficulties have precluded cancer prevention trials with cancer incidence as an endpoint in all but a selected few malignancies for treatments such as tamoxifen and finasteride (Lee KW et al. Nature Reviews Cancer 2011 11 211-218, page 211, left column last paragraph) PRESENCE OR ABSENCE OF EXAMPLES : The specification does not provide any examples of preventing tumors with the claimed antibody. Examples 1 and 2 describes the methods of preparing anti-human PD-L1 monoclonal antibody and the humanized antibody, respectively. Example 3 and 4 describe the pharmacokinetics of the claimed antibody. Lastly, Examples 5 and 6 describe the mechanism of action of the antibody. None of the examples in the instant specification disclose the use of the claimed antibody for preventing tumors /cancers. PREDICTABILITY : The specification lacks the critical steps necessary in presenting some type of predictable response in a population of hosts deemed necessary to prevent tumors with the instantly claimed combination. There is no evidence in the instant application or the art that as noted in the prior that demonstrate that the claimed antibody that treats cancer would prevent the onset of cancer in subjects as claimed. The amount of experimentation to required to formulate such guidance would be enormous; one would have to demonstrate the efficacy of the combination in several models across several different types of cancers and determine the appropriate regimen (doses and frequency) for use of the combination or composition in a preventative setting. Further, one would have to conduct population analysis to identify definitive characteristics which indicate that a subject is at risk of developing any cancer to a degree that would outweigh potential adverse effects of treatment with the claimed combination or composition. Thus, considering the high level of skill in the art, the state of the art, the level of predictability, and the guidance and examples provided, the experimentation required to enable the full scope of the claimed invention would not be reasonable. QUANTITY OF EXPERIMENTATION : Undue experimentation would be required to determine that the claimed antibody administered to which population of subjects could predictably prevent cancer as claimed. MPEP 2164.01 recites that “The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. In re Angstadt , 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976)”. The experimentation needed to practice this method is undue and unreasonable as it requires determining whether the claimed antibody prevents cancer. A person skilled in the art will not be able to use the invention without undue experimentation. (In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)) Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success. 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. Claim 69 is 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. Claim 69 depends on clam 67. Claim 69 recites that the antibody, or antigen binding fragment, may be a fully human antibody. Given claim 67 recites an antibody derived from mice, the limitations of a fully human antibody is outside the scope of claim 69. 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. Closest Prior Art The closest prior art made of record are: US11884724 B2 (Filed 8/4/2020), US8168179 B2 (published 12/3/2009), and US11111300 B2 (published 1/301/2020). The prior art listed above all teach anti-PD-L1 antibodies. However , the art does not teach the antibody or antigen-binding fragment that binds to PD-L1 protein comprising the instantly claimed sequences. Conclusion Conclusion : Claims 69 and 80-82 are rejected. Claims 67-68, 70 - 79, 83-86 are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SARAH A ALSOMAIRY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0027 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 7:30 AM to 5:30 PM . 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, FILLIN "SPE Name?" \* MERGEFORMAT Gregory Emch can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-8149 . 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. /SARAH A ALSOMAIRY/ Examiner, Art Unit 1646 /Zachariah Lucas/ Supervisory Patent Examiner, Art Unit 1600
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Prosecution Timeline

Aug 09, 2023
Application Filed
Mar 26, 2026
Non-Final Rejection — §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

1-2
Expected OA Rounds
60%
Grant Probability
85%
With Interview (+24.7%)
3y 3m
Median Time to Grant
Low
PTA Risk
Based on 134 resolved cases by this examiner. Grant probability derived from career allow rate.

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