Prosecution Insights
Last updated: April 18, 2026
Application No. 18/025,849

TROPHOBLAST GLYCOPROTEIN RADIOIMMUNOTHERAPY FOR THE TREATMENT OF SOLID CANCERS

Non-Final OA §103
Filed
Mar 10, 2023
Examiner
CRAIG, KAILA ANGELIQUE
Art Unit
1618
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Actinium Pharmaceuticals Inc.
OA Round
1 (Non-Final)
33%
Grant Probability
At Risk
1-2
OA Rounds
3y 5m
To Grant
67%
With Interview

Examiner Intelligence

Grants only 33% of cases
33%
Career Allow Rate
20 granted / 60 resolved
-26.7% vs TC avg
Strong +34% interview lift
Without
With
+33.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
49 currently pending
Career history
109
Total Applications
across all art units

Statute-Specific Performance

§101
2.0%
-38.0% vs TC avg
§103
50.1%
+10.1% vs TC avg
§102
16.9%
-23.1% vs TC avg
§112
22.1%
-17.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 60 resolved cases

Office Action

§103
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 I in the reply filed on 1/26/2026 is acknowledged. Claims 41-48 and 55-56 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, and there being no allowable generic or linking claim. Status of Claims Cancelled: 12-40, 49-54, 57-73 Withdrawn: 41-48, 55, 56 Examined Herein: 1-11 Priority Acknowledgment is made of applicant's claim for priority under based upon an application filed in PRO 63/077,297 on 9/11/2020 and in PCT/US2021/050009 on 9/13/2021. Information Disclosure Statement The information disclosure statement (IDS) submitted on 3/10/2023 and 6/16/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . Claim s 1, 3, 5, 6, 7, 9, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Boghaert (US 2010/ 0 173382 A1, Published 7/8/2010) , in view of Satijn (US 2020/0277397 A1, Published 9/3 /2020) . With respect to claim 1, Boghaert discloses a method for treating a cancer in a mammalian subject comprising administering to the subject a therapeutically effective amount of a radiolabeled 5T4 targeting agent (or “anti-5T4 antibody”), wherein the cancer is a solid cancer or leukemia. [ Boghaert , 0201, 0221, 0222, 0141, 0207] With respect to claim 3, Boghaert discloses the 5T4 targeting agent may be chemically conjugated to a chelator. [ Boghaert , 0146] With respect to claim 5, Boghaert discloses the cancer is a 5T4-expressing cancer. [ Boghaert , 0201, 0221, 0141] With respect to claim 6, Boghaert discloses the mammalian subject is human. [ Boghaert , 0222] With respect to claim 7, Boghaert discloses the 5T4 targeting agent is radiolabeled with 131I, 125I, 1231, 90Y, 186Re, 188Re, 225Ac, or 213Bi. [ Boghaert , 0147] With respect to claim 9, Boghaert discloses the 5T4 targeting agent may be radiolabeled with 225Ac. [ Boghaert , 0147] Boghaert further discloses the labeled targeting agent may comprise a dose of 1 mCi to 300 mCi . [ Boghaert , 0222] With respect to claim 10 and 11, Boghaert discloses the 5T4 targeting agent may be radiolabeled with 131I. [ Boghaert , 0147] Boghaert further discloses the labeled targeting agent may comprise a dose of 1 mCi to 300 mCi . [ Boghaert , 0222] Boghaert does not disclose the 5T4 targeting agent is naptumomab estafenatox . However, Satijn discloses naptumomab estafenatox is a 5T4 targeting agent (or “5T4-targeting antibody”). [ Satijn , 0006] Modifying the method disclosed by Boghaert so that the 5T4 targeting agent is naptumomab estafenatox results in the method of claim 1. It would be obvious to one of ordinary skill in the art to modify the method disclosed by Boghaert so that the 5T4 targeting agent is naptumomab estafenatox and have a reasonable expectation of success. Boghaert discloses a method of treating 5T4-expressing cancers comprising administering to a subject a radiolabeled anti-5T4 antibody. Satijn discloses naptumomab estafenatox is an anti-5T4 antibody. Accordingly, the combined teachings of Boghaert and Satijn suggest that naptumomab estafenatox may serve as the anti-5T4 antibody in the method disclosed by Boghaert . Therefore, it is reasonable to expect the method disclosed by Boghaert may be modified so that the 5T4 targeting agent is naptumomab estafenatox . One would have been motivated to do so because the selection of a known material based on its suitability for its intended use is prima facie obvious . MPEP 2144.07 In the instant case, the selection of naptumomab estafenatox based on its suitability as an anti-5T4 antibody for use the method of treating 5T4 expressing cancers disclosed by Boghaert is prima facie obvious. Claim s 1, 2, 3, 5, 6, 7, 9, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Boghaert and Satijn , as applied to claims 1, 3, 5, 6, 7, 9, 10, and 11 a bove, and further in view of Cicic (US 2019/0263903 A1, Published 8/29/2019) . With respect to claim 1, Boghaert and Satijin disclose the teachings above. Boghaert and Satijin do not disclose the administered 5T4 targeting agent has a first portion that is radiolabeled and a remaining portion is not radiolabeled. However, with respect to claim 2, Cicic discloses that when an agent such as an antibody labeled with an alpha-emitting isotope is administered to a subject, the majority of the drug administered typically consists of non-labeled antibody and the minority consists of labeled antibody. [ Cicic , 0041] Modifying the method disclosed by Boghaert and Satijin so that the administered 5T4 targeting agent comprises a first portion that is radiolabeled and a remaining portion that is not radiolabeled, results in the method of claim 2. It would be obvious to one of ordinary skill in the art to modify the method disclosed by Boghaert and Satijin so that the administered 5T4 targeting agent comprises a first portion that is radiolabeled and a remaining portion that is not radiolabeled, and have a reasonable expectation of success. Boghaert and Satijin disclose a method comprising administering to a subject an antibody ( naptumomab estafenatox ) labeled with an alpha-emitting isotope (i.e., 225Ac and 223Ra). Cicic discloses that when an antibody labeled with an alpha-emitting isotope is administered to a subject, the majority of the drug administered typically consists of non-labeled antibody and the minority consists of labeled antibody. Thus, the combined teachings of Boghaert , Satijin , and Cicic suggest that the antibody labeled with an alpha-emitting isotope ([225Ac or 223Ra] naptumomab estafenatox ) administered in the method disclosed by Boghaert and Satijin may consist of non-labeled antibody and labeled antibody. Therefore, it is reasonable to expect the method disclosed by Boghaert and Satijin may be modified so that the administered 5T4 targeting agent comprises a first portion that is radiolabeled and a remaining portion that is not radiolabeled. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Cicic discloses that administering a sub-saturating dose of an antibody labeled with an alpha-emitting isotope avoids toxicity and maintains therapeutic efficacy, in a manner independent of patient age, co-morbidities and disease severity. [ Cicic , 0004-0006] Cicic discloses a sub-saturating dose is achieved by ensuring the ratio of total (i.e., labeled and unlabeled) target antigen-binding sites to target antigens is less than or equal to 9:10. [ Cicic , 0041, 0042] Therefore, one would have been motivated by the expectation that the aforementioned modification could enable the method disclosed by Boghaert and Satijin to achieve minimal toxicity and maintain therapeutic efficacy, in a manner independent of patient age, co-morbidities and disease severity. Claim s 1, 2, 3, 4, 5, 6, 7, 8, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Cuthbertson (US 2020/0016283 A1, Published 1/16/2020) . With respect to claim 1, Cuthbertson discloses a method for treating a cancer in a mammalian subject comprising administering to the subject a therapeutically effective amount of a radiolabeled tissue-targeting radiopharmaceutical, wherein the cancer is a solid cancer or leukemia. [ Cuthbertson , 0010-0027] With respect to claim 3, Cuthbertson discloses the radiopharmaceutical is chemically conjugated to a chelator. [Cuthbertson, 0049, 0058] With respect to claim 4, Cuthbertson discloses the chelator may comprise DOTA. [Cuthbertson, 0058,0059] With respect to claim 5, Cuthbertson discloses the cancer is breast, colorectal, gastric, acute myeloid leukemia, mesothelioma, ovarian, lung or pancreatic cancer. [Cuthbertson, 0023, 0024] The cancers are 5T4-expressing cancers. With respect to claim 6, Cuthbertson discloses the mammalian subject may be human. [Cuthbertson, 0023] With respect to claim 7, Cuthbertson discloses the radiopharmaceutical is radiolabeled with 227Th. [Cuthbertson, 0013] Cuthbertson further discloses the radiopharmaceutical may be radiolabeled with 225Ac, 213Bi, 211At, 223Ra, 227Th, or 149Tb. [Cuthbertson, 0047, 0048] With respect to claim 8 and 9, Cuthbertson discloses the radiopharmacutical may be radiolabeled with 225Ac. [Cuthbertson, 0047] Cuthbertson further discloses the effective amount of the labeled radiopharmaceutical may comprise a dose of 0.5 to 5 μCi /kg (20 to 200 kbq /kg) body weight of the subject. [Cuthbertson, claim 1 and 15] With respect to claim 11, Cuthbertson discloses the effective amount of the radiopharmaceutical comprises a protein dose of 0.02-1 mg/kg body weight of the subject. [ Cuthbertson, 0097] Cuthbertson does not explicitly disclose the subject is administered a 5T4 targeting agent. However, with respect to claim 1, Cuthbertson discloses the tissue-targeting radiopharmaceutical may be naptumomab estafenatox (a 5T4 targeting agent). [ Cuthbertson, 0037] Modifying the method disclosed by Cuthbertson so that the tissue-targeting radiopharmaceutical is naptumomab estafenatox results in the method of claim 1. It would be obvious to one of ordinary skill in the art to modify the method disclosed by Cuthbertson so that the tissue-targeting radiopharmaceutical is naptumomab estafenatox and have a reasonable expectation of success. Cuthbertson discloses a method for treating cancer comprising administering a radiolabeled tissue- targeting radiopharmaceutical . Cuthbertson further discloses the tissue-targeting radiopharmaceutical may be naptumomab estafenatox . In view of this express teachings, it is reasonable to expect the method disclosed by Cuthbertson may be modified so that the tissue-targeting radiopharmaceutical is naptumomab estafenatox . One would have been motivated to do so because the selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07 In the instant case, the selection of naptumomab estafenatox based on its suitability as a tissue- targeting moiety for use the method disclosed by Cuthbertson is prima facie obvious. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KAILA A CRAIG whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-4540 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 0800-1600 . 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 Michael Hartley can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-0616 . 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. /K.A.C./ Examiner, Art Unit 1618 /Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618
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Prosecution Timeline

Mar 10, 2023
Application Filed
Apr 01, 2026
Non-Final Rejection — §103 (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
33%
Grant Probability
67%
With Interview (+33.7%)
3y 5m
Median Time to Grant
Low
PTA Risk
Based on 60 resolved cases by this examiner. Grant probability derived from career allow rate.

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