Prosecution Insights
Last updated: April 19, 2026
Application No. 18/285,063

CANCER THERAPY USING TOLL-LIKE RECEPTOR AGONISTS

Non-Final OA §102§103§112§DP
Filed
Sep 29, 2023
Examiner
HUDSON, AMY ROSE
Art Unit
1636
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
TriSalus Life Sciences, Inc.
OA Round
1 (Non-Final)
75%
Grant Probability
Favorable
1-2
OA Rounds
2y 7m
To Grant
86%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allow Rate
1076 granted / 1432 resolved
+15.1% vs TC avg
Moderate +11% lift
Without
With
+11.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
60 currently pending
Career history
1492
Total Applications
across all art units

Statute-Specific Performance

§101
3.0%
-37.0% vs TC avg
§103
33.6%
-6.4% vs TC avg
§102
14.5%
-25.5% vs TC avg
§112
33.2%
-6.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1432 resolved cases

Office Action

§102 §103 §112 §DP
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 Rejections - 35 USC § 112 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 7, 8, and 10-12 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. Clam 7 recites that the TLR9 agonist “may” be administered through a catheter device. Recitation of “may” does not recite a requirement and therefore the claim does not further limit the base claim. Claim 9 is not included in the rejection because it requires the administration through a catheter device rather than recitation of “may”. 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. 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. Claim s 1-18 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 TLR9 agonism and treatment of hepatocellular carcinoma with the instant oligomer , does not reasonably provide enablement for a method of treating any possible primary liver cancer via delivery of the instant TLR9 agonist alone . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Factors to be considered in a determination of lack of enablement include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) The claims are directed to a method for treating any primary liver cancer via delivery of the instant oligomer. The specification demonstrates delivery of the instant TLR9 agonist oligomer and resultant TLR agonism, but does not draw an adequate nexus between TLR9 agonism and the predictable treatment of any possible primary liver cancer, or more specifically ICC. Mohamed et al. (Gut, July 2012, Vol 61, Suppl 2, PMO-091) teach that TLR9 inhibition is a novel target of therapy for primary liver cancer. Mohamed et al. teach that: Our study indicates that TLR9 activation increases cell proliferation whereas inhibition reduces it. Our data suggest that TLR9 may be associated with tumor proliferation and may provide a potential target for therapy in liver tumors . Therefore, inhibition rather than agonism of TLR9 would be expected to treat some primary liver cancers. Mohamed et al. (D igestive Diseases and Sciences (2022) 67:1806–1821 ) teach that i nhibition of TLR9 r educes h uman c holangiocarcinoma (a primary liver cancer) c ell p roliferation and t umor d evelopment (title). Therefore, agonism of TLR9 would not be expected to treat all possible primary liver cancers. The scope of the claims in view of the specification as filed together do not reconcile the unpredictability in the art to enable one of skill in the art to make and/or use the claimed invention, namely a broad method of treating any possible primary liver cancer via delivery of a TLR9 agonist comprising the instant TLR9 agonist oligomer . MPEP 2164.01 Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed , contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. Also, MPEP 2164.01(a) A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed , would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Given the teachings of the specification as discussed above, one skilled in the art could not predict a priori whether introduction of a TLR9 agonist comprising the instant oligomer would result in successful treatment of any possible primary liver cancer . To practice the claimed invention, one of skill in the art would have to de novo determine; the stability of the molecule in vivo , delivery of the molecule to the whole organism, specificity to the target tissue in vivo , dosage and toxicity in vivo , and entry of the molecule into the cell in vivo and the effective action therein. Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention. A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed , would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation (see MPEP 2164.01(a)). Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 1, 2, 5, 6, 13, and 14 is/are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Krieg (US 10,682,365 B2). Krieg teaches: Provided are methods for treating cancer using local administration of certain CpG oligonucleotides (CpG ODN) and systemic administration of a checkpoint inhibitor such as an anti-PD-1 antibody, an anti-PD-L1 antibody, and/or an anti-CTLA-4 antibody (abstract) . Krieg teaches that the CpG ODN can bind and stimulate TLR9 (column 3) and that the ODN sequence is 100% identical to instant SEQ ID NO: 1 (Table 2, last sequence, CpG-A oligo) (instant claim 1). Krieg teaches a method of treating a primary liver cancer via delivery of the oligomer. Krieg teaches: Combination of high IFN-inducing CpG ODN and anti-PD-1, anti-PD-L1, or anti-CTLA-4 is useful for treatment of primary and secondary (i.e., metastatic) cancers . More specifically, among many potential treatment options, CpG ODN and anti-checkpoint combination therapy can be used to treat cancer. In certain embodiments, the cancer to be treated is or includes a cancerous tumor. A “cancerous tumor” as used herein refers to an abnormal swelling or macroscopic collection of cells comprising abnormal cells characterized by their growth or proliferation without regulation by normal external signals. In certain embodiments, a cancerous tumor is a carcinoma, sarcoma, or adenocarcinoma; these are sometimes referred to as solid tumors. In certain embodiments, a cancerous tumor excludes hematologic malignancies. In certain embodiments, a cancerous tumor includes certain hematologic malignancies, e.g., lymphomas. (column 76) (instant claim 1). Krieg teaches that the cancer can be hepatocellular carcinoma or cholangiocarcinoma (columns 74 and 77) (instant claim 2). Krieg teaches: Provided are methods for treating cancer using local administration of certain CpG oligonucleotides (CpG ODN) and systemic administration of a checkpoint inhibitor such as an anti-PD-1 antibody, an anti-PD-L1 antibody, and/or an anti-CTLA-4 antibody (abstract) (instant claim 13). Krieg teaches: “Combination therapy” embraces administration of these therapeutic agents in a sequential manner, that is, wherein each therapeutic agent is administer ed at a different time, as well as administration of these therapeutic agents, or at least two of the therapeutic agents, in a substantially simultaneous manner. Sequential or substantially simultaneous administration of each therapeutic agent can be effected by any appropriate route as described herein, including, but not limited to, intratumoral and peritumoral routes; systemic routes, e.g., intravenous, intraperitoneal, enteric (including oral), intramuscular, subcutaneous, and transmucosal routes; and topical and transdermal routes. As described herein, generally a first therapeutic agent (e.g., CpG ODN) can be administer ed by intratumoral or peritumoral injection, and a second agent (e.g., anti-PD-1 antibody) can be administer ed systemically (e.g., intravenously) (column 18 (instant claim 13 ). Krieg teaches that the anti-PD-1 antibody can be nivolumab, pembrolizumab (column 68), or ipiliumumab (column 70)(instant claim 14). Krieg teach that the subject doses of CpG ODN for intratumoral and peritumoral delivery typically range from about 10ug to about 100 mg per administration and could be given daily, weekly, or monthly and any time therebetween ; or 1-50 mg per dose (column 90) ; or 1mg-10mg per dose (column 91) (instant claims 5 and 6). Therefore, the claims are anticipated by Krieg. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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) 3, 4, 7-12, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krieg (US 10,682,365 B2), as applied to claim s 1, 2, 5, 6, 13, and 14 above, and further in view of Morris et al. (J Immunother Cancer 2020;8(Suppl 3):A360-A361), Anand et al. (US 2019/0160254 A1) , and Carpentier et al. (Neuro-Oncology 12(4):401–408, 2010) . Krieg teaches that the CpG ODN can bind and stimulate TLR9 (column 3) and that the ODN sequence is 100% identical to instant SEQ ID NO: 1 (Table 2, last sequence, CpG-A oligo). Krieg teaches a method of treating a primary liver cancer via delivery of the oligomer. Krieg teaches: Combination of high IFN-inducing CpG ODN and anti-PD-1, anti-PD-L1, or anti-CTLA-4 is useful for treatment of primary and secondary (i.e., metastatic) cancers . More specifically, among many potential treatment options, CpG ODN and anti-checkpoint combination therapy can be used to treat cancer. In certain embodiments, the cancer to be treated is or includes a cancerous tumor. A “cancerous tumor” as used herein refers to an abnormal swelling or macroscopic collection of cells comprising abnormal cells characterized by their growth or proliferation without regulation by normal external signals. In certain embodiments, a cancerous tumor is a carcinoma, sarcoma, or adenocarcinoma; these are sometimes referred to as solid tumors. In certain embodiments, a cancerous tumor excludes hematologic malignancies. In certain embodiments, a cancerous tumor includes certain hematologic malignancies, e.g., lymphomas. (column 76) (instant claim 1). Krieg teaches that the cancer can be hepatocellular carcinoma or cholangiocarcinoma (columns 74 and 77) (instant claim 2). These claims are anticipated, as set forth in the rejection under 35 U.S.C. 102(a)(1) and (a)(2), above. Morris et al. is additional evidence that it was known to deliver a TLR9 agonist to treat hepatocellular carcinoma, a species recited in instant claim 2. It would have been obvious to deliver known TLR9 agonists to treat hepatocellular carcinoma. Krieg does not teach that the TLR9 agonist is administered through a device by hepatic arterial infusion (instant claim 3) or a device by portal vein infusion (instant claim 4). Krieg does not teach administration through a catheter (instant claim 7) that comprises a one-way valve that responds dynamically to local pressure and/or flow changes (instant claim 8) or via pressure-enabled drug delivery via the catheter (instant claim 9). However, Krieg does teach administration via infusion (column 89) and teaches: vehicles or delivery device s for delivering oligonucleotides and/or antigens to surfaces have been described. The CpG ODN and/or the antigen and/or other therapeutics may be administered alone (e.g., in saline or buffer) or using any delivery vehicles known in the art (column 95). It was known in the art that oligonucleotides can be delivered via a catheter with a one-way valve to control the direction of fluid flow, as taught by Anand et al. ([0011][0013][0180]); wherein the delivery is via pressure-enabled drug delivery [0009]. The valve responds to pressure/flow [0192]. It would have been obvious to deliver the oligomer of Krieg via the catheter of Anand with a reasonable expectation of controlled delivery of the drug, a benefit taught by Anand (instant claims 7-9). Anand et al. teach: For example, the systems and methods disclosed herein can be used for intraarterial or intravenous delivery. Such systems and methods can include infusion and/or aspiration that is coordinated with one or more physiological parameters of a patient (e.g., natural CSF flow, heart rate, respiration rate, etc.) [0224]. When targeting liver cancers, it would have been obvious to utilize the delivery systems of Anand et al. for hepatic arterial or portal vein infusion in a controlled manner as a matter of design choice given that it was known to be a delivery device for oligomers (instant claims 3 and 4). Krieg does not teach administration for 10-100, 10-60, or for about 25 minutes (instant claims 10-12) ; or once per week over three consecutive weeks (instant claim 16) . However, Krieg teaches that Krieg teaches: Administration of these therapeutic agents in combination typically is carried out over a defined time period (usually minutes , hours, days, or weeks depending upon the combination selected) (column 18); and teaches that : the skilled artisan would appreciate, based upon the disclosure provided herein, that the dose and dosing regimen is adjusted in accordance with methods well-known in the therapeutic arts. That is, the maximum tolerable dose can be readily established, and the effective amount providing a detectable therapeutic benefit to a patient can also be determined, as can the temporal requirements for administer ing each agent to provide a detectable therapeutic benefit to the patient. Accordingly, while certain dose and administration regimens are exemplified herein, these examples in no way limit the dose and administration regimen that can be provided to a patient in practicing the present invention. Further, one skilled in the art would understand, once armed with the teachings provided herein, that a therapeutic benefit, such as, but not limited to, detectable decrease in tumor size and/or metastasis, and increased time to recurrence, among many other parameters, can be assessed by a wide variety of methods known in the art for assessing the efficacy of treatment of cancer, and these methods are encompassed herein, as well as methods to be developed in the future (columns 87 and 88). Krieg teach that the subject doses of CpG ODN for intratumoral and peritumoral delivery typically range from about 10ug to about 100 mg per administration and could be given daily, weekly, or monthly and any time therebetween; or 1-50 mg per dose (column 90); or 1mg-10mg per dose (column 91). Therefore , administration of the instantly dosage schedules is considered to be a matter of design choice and well within the technical grasp of one of ordinary skill in the art. Krieg teaches that administration is carried out over minutes and teaches that the parameters are routinely established (instant claims 10-12, 16, and 17). Krieg teaches: Provided are methods for treating cancer using local administration of certain CpG oligonucleotides (CpG ODN) and systemic administration of a checkpoint inhibitor such as an anti-PD-1 antibody, an anti-PD-L1 antibody, and/or an anti-CTLA-4 antibody (abstract). Krieg teaches that the anti-PD-1 antibody can be nivolumab, pembrolizumab (column 68), or ipiliumumab (column 70)(instant claim 18). Carpentier et al. is additional evidence that it was known to deliver CpG-ODN via catheters implanted in the tumor mass in patients. The primary objective was efficacy, based on PFS. Secondary outcomes were tolerance, survival, and radiological response (page 402). 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. Claim s 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1- 11 and 15-18 of copending Application No. 18/730,982 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of application ‘982 are directed to : a method for treating liver immune dysfunction comprising administering to a subject in need thereof a therapeutically effective amount of a toll-like receptor 9 agonist having the structure: 5'-TCG AAC GTT CGA ACG TTC GAA CGT TCG AAT-3' (SEQ ID NO: 1), wherein the liver immune dysfunction is induced by at least one tumor resulting from metastasis in the liver or at least one primary liver cancer (claim 1). Therefore, application ‘982 is directed to treating a patient that has a primary liver cancer with the same oligomer as instantly recited (instant claim 1). Additionally, primary liver cancer can be considered to be a liver immune dysfunction due to its ability to evade the immune system. The claims are directed to the same modes of administration/delivery devices, dosing, and checkpoint inhibitors. The claims are obvious variations of each other. The remainder of the claims of application ‘982 and correlation to the instant claims are as follows: 2. (Original) The method of claim 1, wherein the TLR9 agonist is administered through a device by hepatic arterial infusion (HAI) (instant claim 3) . 3. (Original) The method of claim 1, wherein the TLR9 agonist is administered through a device by portal vein infusion (PVI) (instant claim 4) . 4. (Original) The method of claim 1, wherein the therapeutically effective amount of the TLR9 agonist administered is in the range of about 0.01-20 mg (instant claims 5 and 6) . 5. (Original) The method of claim 4, wherein the therapeutically effective amount of the TLR9 agonist administered is selected from the group consisting of 2 mg, 4 mg, or 8 mg (instant claim 6) . 6. (Currently Amended) The method of claim 1, wherein the TLR9 agonist may be administered through a catheter device (instant claim 7) . 7. (Original) The method of claim 6, wherein the catheter device comprises a one-way valve that responds dynamically to local pressure and/or flow changes (instant claim 8) . 8. (Original) The method of claim 6, wherein the TLR9 agonist is administered through the catheter device via pressure-enabled drug delivery (instant claim 9) . 9. (Original) The method of claim 6, wherein the TLR9 agonist is administered for a period of time of about 10-200 minutes (instant claim 10) . 10. (Original) The method of claim 9, wherein the TLR9 agonist is administered for a period of time of about 10-60 minutes (instant claim 11) . 11. (Original) The method of claim 10, wherein the TLR9 agonist is administered for a period of time of about 25 minutes (instant claim 12) . 15. (Currently Amended) The method of claim 1 , wherein the TLR9 agonist is administered in combination with one or more checkpoint inhibitors (instant claim 13) . 16. (Original) The method of claim 15, wherein the checkpoint inhibitors are administered systemically, either concurrently, before, or after the administration of the TLR9 agonist (instant claim 13) . 17. (Original) The method of claim 16, wherein the one or more checkpoint inhibitors include at least one of nivolumab, pembrolizumab, and ipilimumab (instant claims 14 and 18) . 18. (Original) The method of claim 16, wherein the administration of the TLR9 agonist comprises a dosing regimen comprising cycles, in which one or more of the cycles comprise the administration of the TLR9 agonist via a catheter device by hepatic arterial infusion followed by the systemic administration of the one or more checkpoint inhibitors (instant claim s 15 -17 ) . The administration once per week for three weeks in an obvious species of dosing regimen that falls within the scope of claim 18. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Amy R Hudson whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0755 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8:00am-6:00pm . 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 Neil Hammell can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5919 . 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. /AMY ROSE HUDSON/ Primary Examiner, Art Unit 1636
Read full office action

Prosecution Timeline

Sep 29, 2023
Application Filed
Feb 24, 2026
Non-Final Rejection — §102, §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12600969
EXPRESSION CONTROL USING A REGULATABLE INTRON
2y 5m to grant Granted Apr 14, 2026
Patent 12595479
ANTISENSE OLIGONUCLEOTIDE-BASED PROGRANULIN AUGMENTATION THERAPY IN NEURODEGENERATIVE DISEASES
2y 5m to grant Granted Apr 07, 2026
Patent 12595483
TREATMENT OF TUMORS WITH MIRNA TARGETING CDK4/CDK6
2y 5m to grant Granted Apr 07, 2026
Patent 12589133
METHODS OF DOWNREGULATING CCL20 GENES FOR TREATMENT OF TRAUMATIC BRAIN INJURIES
2y 5m to grant Granted Mar 31, 2026
Patent 12584132
NUCLEIC ACID DRUG TARGETING MURF1
2y 5m to grant Granted Mar 24, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

1-2
Expected OA Rounds
75%
Grant Probability
86%
With Interview (+11.3%)
2y 7m
Median Time to Grant
Low
PTA Risk
Based on 1432 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month