Prosecution Insights
Last updated: April 19, 2026
Application No. 18/553,043

METHODS FOR TREATING CANCER USING ANTI-CTLA4 ANTIBODIES

Non-Final OA §103§112§DP
Filed
Sep 28, 2023
Examiner
MERTZ, PREMA MARIA
Art Unit
1674
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Adagene Pte. Ltd.
OA Round
1 (Non-Final)
72%
Grant Probability
Favorable
1-2
OA Rounds
2y 10m
To Grant
99%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allow Rate
539 granted / 754 resolved
+11.5% vs TC avg
Strong +36% interview lift
Without
With
+35.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
16 currently pending
Career history
770
Total Applications
across all art units

Statute-Specific Performance

§101
5.9%
-34.1% vs TC avg
§103
21.7%
-18.3% vs TC avg
§102
13.9%
-26.1% vs TC avg
§112
41.2%
+1.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 754 resolved cases

Office Action

§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. New c laims 47-66, (5/23/2024) are pending and under consideration by the Examiner. Claims 1-46 have been canceled. Information Disclosure Statement 3. The information disclosure statement (IDS) submitted on 4/9/2024 is in compliance with the provisions of 37 CFR 1.97 and has been considered by the examiner. Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section”. Claim Rejections - 35 USC § 112(b) 4 . 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. 4 a. Claims 47-66 are 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 pre-AIA the applicant regards as the invention. Claim 47 is rejected as vague and indefinite for several reasons. Claim 47 is vague and indefinite because it recites “a method of treating a cancer” rather than correctly recite “a method of reducing size of a solid tumor …….wherein the solid tumor is urothelial cancer, renal cell carcinoma, or pancreatic cancer”, because the listed cancers all encompass solid tumor s . Claim 47 recites the limitation "is a subject" in line 3, rather than the grammatically correct “in a subject”. Claim 51 is an improper Markush claim because it recites both species of cancer ( urothelial cancer, renal cell carcinoma, or pancreatic cancer ) and genus of cancer (solid cancer, advanced-stage cancer, or metastatic cancer ) in the same claim. This rejection can be obviated by reciting the species of cancers with solid tumors, i.e. urothelial cancer, renal cell carcinoma, or pancreatic cancer. Similarly, claim 66 is an improper Markush claim because it recites both species of cancer (urothelial cancer, renal cell carcinoma, or pancreatic cancer) and genus of cancer (solid cancer, advanced-stage cancer, or metastatic cancer ) in the same claim. This rejection can be obviated by reciting the species of cancers with solid tumors, i.e. urothelial cancer, renal cell carcinoma, or pancreatic cancer. Similarly, claim 64 is an improper Markush claim because it recites both species of inhibitor (anti-PD-1 antibody) and genus of inhibitor ( inhibitor of CTLA4, PD-1 or a PD-1 ligand) in the same claim. This rejection can be obviated by reciting the species of inhibitor i.e. anti-PD-1 antibody. Claim 65 recites the limitation "the anti-PD-1 antibody " in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 52 is vague and indefinite because it recites “a method of treating a cancer” rather than recite “a method of reducing size of a solid tumor …….wherein the solid tumor is urothelial cancer, renal cell carcinoma, or pancreatic cancer”, because the listed cancers all encompass solid tumors. Claim 60 is vague and indefinite because it recites the limitation “ about 50 nM to about 700 nM” and it is unclear if this limitation encompasses “10nM to 800nM” or even “5nM to 1000nM. Amendment of the claim to delete the term “about” would obviate this rejection. Claim 61 is vague and indefinite because it recites the limitation “ about 100 nM to about 500 nM” and it is unclear if this limitation encompasses “10nM to 800nM” or even “5nM to 1000nM. Amendment of the claim to delete the term “about” would obviate this rejection. Claim 62 is vague and indefinite because it recites the limitation “ about 100 nM to about 400 nM” and it is unclear if this limitation encompasses “10nM to 800nM” or even “5nM to 1000nM. Amendment of the claim to delete the term “about” would obviate this rejection. Claims 48-50, 53-59, and 63, are rejected as vague and indefinite insofar as they depend on the above rejected claim s for their limitations. Claim rejections-35 U.S.C. 103 5 . 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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a). The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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. 5 a. Claims 47-66 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 11,359,016 (‘016) . The reference teaches a method of treating or delaying progression of cancer in a subject and reducing the size of solid tumors comprising administering to a subject in need thereof an activatable antibody comprising: a first polypeptide comprising, from N-terminus to C-terminus, a masking moiety (MM), a cleavable moiety (CM), and a target binding moiety (TBM), wherein the MM comprises an amino acid sequence selected from the group consisting of SEQ ID NOs: 189-193, 195-196, and 213-216; wherein the CM comprises at least a first cleavage site; wherein: a) the TBM comprises an antibody light chain variable region (VL), and the activatable antibody further comprises a second polypeptide comprising an antibody heavy chain variable region (VH); b) the TBM comprises an antibody heavy chain variable region (VH), and the activatable antibody further comprises a second polypeptide comprising an antibody light chain variable region (VL); c) the TBM comprises from the N-terminus to the C-terminus, an antibody light chain variable region (VL) and an antibody heavy chain variable region (VH); or d) the TBM comprises from the N-terminus to the C-terminus, an antibody heavy chain variable region (VH) and an antibody light chain variable region (VL); wherein the VH comprises an HVR-H1 comprising the amino acid sequence YSISSGYHWSWI (SEQ ID NO: 23), an HVR-H2 comprising the amino acid sequence LARIDWDDDKYYSTSLKSRL (SEQ ID NO: 35), and an HVR-H3 comprising the amino acid sequence ARSYVYFDY (SEQ ID NO: 45); wherein the VL comprises an HVR-L1 comprising the amino acid sequence RASQSVRGRFLA (SEQ ID NO: 58), an HVR-L2 comprising the amino acid sequence DASNRATGI (SEQ ID NO: 66), and an HVR-L3 comprising the amino acid sequence YCQQSSSWPPT (SEQ ID NO: 75); and wherein the activatable antibody binds to human CTLA4 via the VH and VL when the CM is cleaved , and wherein the anti-CTLA4 antibody comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 87, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 100, which encompass six CDR sequences and heavy and light chain variable regions are 100% identical to those in the instant application (See Examples 17-19, columns 114-116; Figures 42A-42B, 43-44, 45A-45B, 60A-60B, 61A-61B, 62A-62B, 64A-64B; See claims 1, 1 5 -18, 27-33). The reference teaches t he same antibody administered to treat the same condition as in the instant claims . The prior art is silent with respect to the limitation s that subject is resistant to or has relapsed from a prior therapy, wherein the prior therapy is an inhibitor of CT L A4, PD- 1 , or a PD- 1 ligand, and that the anti-CTLA4 antibody is administered at a dose of from 3 mg/kg to 20 mg/kg, wherein the anti-CTLA4 antibody is administered about once every three weeks. It would have been obvious to one of ordinary skill in the art, at the time the instant invention was conceived, to modify the method of ‘016 and administer the CTLA4 antibody of ‘016 to a subject that is resistant to or has relapsed from a prior therapy such as therapy with an anti-PD-1 antibody because the ‘016 reference method teaches the success of using the claimed anti-CTLA4 antibody for reduction of tumor volume in a subject . When treatment with an antibody is resistant , one of skill in the art would be motivated to explore alternative antibodies that have been shown to be successful, to improve treatment outcomes. By implementing these strategies, healthcare provides can continue to provide patients with effective cancer treatments, even when the prior therapy becomes resistant. Here, the recited functional characterization outcomes in the claimed method would naturally and necessarily flow from the method disclosed in the prior art. Accordingly, the prior art teaches the same method claimed, and the treatment product used in the prior art method is the same as the claimed method. Therefore, the claimed functional outcome would naturally and necessarily flow from the method of treatment disclosed in the prior art. Since the office does not have a laboratory to test the reference materials, it is Applicant’s burden to show that the reference material does not have the properties recited in the instant claims. See In re Best , 195 USPQ 430, 433 (CCPA 1977); In re Marosi , 218 USPQ 289, 292-293 (Fed. Cir. 1983); and In re Fitzgerald et al ., 205 USPQ 594 (CCPA 1980). Furthermore, it would have been obvious to one of ordinary skill in the art, in this case, an oncologist, to monitor the dosage and have the motivation and ability to optimize the best administration dosage and schedule of administration, to obtain the best and efficacious course of treatment. Times of dosage, like dosage of administration, are “result effected variables”, that have an effect on the outcome of a method. Furthermore, such determination would have been well-within the skill set of one of ordinary skill in the art. Therefore, the teachings of the reference renders obvious claims 47-66 in the absence of evidence to the contrary. 5b. Claims 47-66 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 11, 692 ,0 3 6 (‘016). The reference teaches a method of treating or delaying progression of cancer in a subject or reducing the size of solid tumors comprising administering to a subject in need thereof the method comprising administering to the subject an effective amount of an anti-CTLA4 antibody, wherein the antibody comprises an HVR-H1 comprising the amino acid sequence YSISSGYHWSWI (SEQ ID NO: 23), an HVR-H2 comprising the amino acid sequence LARIDWDDDKYYSTSLKSRL (SEQ ID NO:35), an HVR-H3 comprising the amino acid sequence ARSYVYFDY (SEQ ID NO: 45), an HVR-L1 comprising the amino acid sequence RASQSVRGRFLA (SEQ ID NO: 58), an HVR-L2 comprising the amino acid sequence DASNRATGI (SEQ ID NO: 66), and an HVR-L3 comprising the amino acid sequence YCQQSSSWPPT (SEQ ID NO: 75) ( S ee claims 1, 27-28 ). T he anti-CTLA4 antibody recited in claim 21 of ‘036 comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 87, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 100, whic h encompass six CDR sequences and heavy and light chain variable regions which are 100% identical to those in the instant application . (See Examples 17-19, columns 114-116; Figures 42A-42B, 43-44, 45A-45B, 60A-60B; See claims 1, 27- 28 ). The reference teaches t he same antibody administered to treat the same condition as in the instant claims. The prior art is silent with respect to the limitation s that subject is resistant to or has relapsed from a prior therapy, wherein the prior therapy is an inhibitor of CTLA4, PD-1, or a PD-1 ligand, and that the anti-CTLA4 antibody is administered at a dose of from 3 mg/kg to 20 mg/kg, wherein the anti-CTLA4 antibody is administered about once every three weeks. It would have been obvious to one of ordinary skill in the art, at the time the instant invention was conceived, to modify the method of ‘0 3 6 and administer the CTLA4 antibody of ‘0 3 6 to a subject that is resistant to or has relapsed from a prior therapy such as therapy with an anti-PD-1 antibody because the ‘0 3 6 reference method teaches the success of using the claimed anti-CTLA4 antibody for reduction of tumor volume in a subject. When treatment with an antibody is resistant, one of skill in the art would be motivated to explore alternative antibodies that have been shown to be successful, to improve treatment outcomes. By implementing these strategies, healthcare provides can continue to provide patients with effective cancer treatments, even when the prior therapy becomes resistant. Here, the recited functional characterization outcomes in the claimed method would naturally and necessarily flow from the method disclosed in the prior art. Accordingly, the prior art teaches the same method claimed, and the treatment product used in the prior art method is the same as the claimed method. Therefore, the claimed functional outcome would naturally and necessarily flow from the method of treatment disclosed in the prior art. Since the office does not have a laboratory to test the reference materials, it is Applicant’s burden to show that the reference material does not have the properties recited in the instant claims. See In re Best , 195 USPQ 430, 433 (CCPA 1977); In re Marosi , 218 USPQ 289, 292-293 (Fed. Cir. 1983); and In re Fitzgerald et al ., 205 USPQ 594 (CCPA 1980). Furthermore, it would have been obvious to one of ordinary skill in the art, in this case, an oncologist, to monitor the dosage and have the motivation and ability to optimize the best administration dosage and schedule of administration, to obtain the best and efficacious course of treatment. Times of dosage, like dosage of administration, are “result effected variables”, that have an effect on the outcome of a method. Furthermore, such determination would have been well-within the skill set of one of ordinary skill in the art. Therefore, the teachings of the reference render s obvious claims 47-66 in the absence of evidence to the contrary. Claim rejections-Double Patenting Non-statutory double patenting rejection (obviousness-type) 6. The non-statutory 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 non-statutory double patenting rejection is appropriate where the claims at issue 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); and 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 non-statutory 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 non-statutory 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. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). 6 a. Claims 47-66 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 5 -17, and 27-33 of US Patent No. 11, 359 , 016 (‘0 16 ). Although the claims at issue are not identical, they are not patentably distinct from each other because , specifically claim 15 in ‘ 016 recites a method of treating or delaying progression of cancer in a subject in need thereof, the method comprising administering to the subject an effective amount of an activatable antibody comprising: a first polypeptide comprising, from N-terminus to C-terminus, a masking moiety (MM), a cleavable moiety (CM), and a target binding moiety (TBM), wherein the MM comprises an amino acid sequence selected from the group consisting of SEQ ID NOs: 189-193, 195-196, and 213-216; wherein the CM comprises at least a first cleavage site; wherein: a) the TBM comprises an antibody light chain variable region (VL), and the activatable antibody further comprises a second polypeptide comprising an antibody heavy chain variable region (VH); b) the TBM comprises an antibody heavy chain variable region (VH), and the activatable antibody further comprises a second polypeptide comprising an antibody light chain variable region (VL); c) the TBM comprises from the N-terminus to the C-terminus, an antibody light chain variable region (VL) and an antibody heavy chain variable region (VH); or d) the TBM comprises from the N-terminus to the C-terminus, an antibody heavy chain variable region (VH) and an antibody light chain variable region (VL); wherein the VH comprises an HVR-H1 comprising the amino acid sequence YSISSGYHWSWI (SEQ ID NO: 23), an HVR-H2 comprising the amino acid sequence LARIDWDDDKYYSTSLKSRL (SEQ ID NO: 35), and an HVR-H3 comprising the amino acid sequence ARSYVYFDY (SEQ ID NO: 45); wherein the VL comprises an HVR-L1 comprising the amino acid sequence RASQSVRGRFLA (SEQ ID NO: 58), an HVR-L2 comprising the amino acid sequence DASNRATGI (SEQ ID NO: 66), and an HVR-L3 comprising the amino acid sequence YCQQSSSWPPT (SEQ ID NO: 75); and wherein the activatable antibody binds to human CTLA4 via the VH and VL when the CM is cleaved . Specifically claim 16 recites a method of reducing size of a solid tumor in a subject in need thereof, wherein the solid tumor has a size of about 400-1000 mm 3 , the method comprising administering to the subject an effective amount of the same activatable antibody . T he anti-CTLA4 antibody of ‘016 (recited in claim 18) comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 87, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 100, which six CDR sequences and heavy and light chain variable regions are 100% identical to those in the instant application (See claims 1, 15-18, 27-33). In instant independent claim 47, a method of treating a cancer in a subject, comprising administering to the subject an effective amount of an anti-CTLA4 antibody, wherein the subject is resistant to or has relapsed from a prior therapy, wherein the prior therapy is an inhibitor of CT L A4, PD- 1 , or a PD- 1 ligand, wherein the anti-CTLA4 antibody comprises an HVR-H1 comprising the amino acid sequence of SEQ ID NO: 23, an HVR-H2 comprising the amino acid sequence of SEQ ID NO: 35, an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 45, an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 58, an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 66, and an HVR-L3 comprising the amino acid sequence of SEQ ID NO: 75, is claimed. In instant independent claim 52, a method of treating a cancer in a subject, comprising administering to the subject an effective amount of an anti-CTLA4 antibody, wherein the anti-CTLA4 antibody is administered at a dose of from 3 mg/kg to 20 mg/kg, wherein the anti-CTLA4 antibody is administered about once every three weeks, and wherein the anti-CTLA4 antibody comprises an HVR-H1 comprising the amino acid sequence of SEQ ID NO: 23, an HVR-H2 comprising the amino acid sequence of SEQ ID NO: 35, an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 45, an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 58, an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 66, and an HVR-L3 comprising the amino acid sequence of SEQ ID NO: 75, is claimed. Instant independent claim s 47 and 52 are a species of claims 15-17, and 27-33 in the ‘ 016 patent and encompass subject matter to which the claims in the ‘ 016 patent are generic because a method as recited in instant claims 47-66 is encompassed by the method of claims 15-17, and 27- 33 of the ‘0 16 patent, and in both applications the same antibody is administered to treat the same condition. In instant claim 47, a subpopulation of cancer patients is administered the same antibody for the same condition. However, the instant claims are obvious from the patented claims because the instant claims are directed to one specific embodiment encompassed by the patented claims. The instant method is included in the method claims of the patent and both sets of claims are of overlapping scope. It would have been obvious to one of ordinary skill in the art at the time the present invention was made, that a method as recited in the instant claims, was included in the method as recited in the patented claims. Furthermore, it would have been obvious to o ne of ordinary skill in the art , in this case , a n oncologist , to monitor the dosage and have the motivation and ability to optimize the best administration dosage and schedule of administration , to obtain the best and efficacious course of treatment. Times of dosage, like dosage of administration, are “result effected variables”, that have an effect on the outcome of a method. Furthermore, s uch determination would have been well-within the skill set of one of ordinary skill in the art . Furthermore, the person of ordinary skill in the art, in this case an oncologist , would have expected success for reducing tumor volume where the subject was resistant or has relapsed from a prior therapy because the method of the instant claims was already being successfully used at the time the instant invention was made. Therefore, the claimed invention is obvious over the claims of ‘016. The patented claims if infringed upon would also result in infringement of the claims of the instant application. Allowance of the pending claims, therefore, would have the effect of extending the enforceable life of the allowed claims beyond the statutory limit. 6 b . Claims 47-66 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 27-28 of US Patent No. 11, 692 ,0 36 (‘0 36 ). Although the claims at issue are not identical, they are not patentably distinct from each other because, specifically claim 27 in ‘0 3 6 recites a method of treating or delaying progression of cancer in a subject in need thereof, the method comprising administering to the subject an effective amount of an anti-CTLA4 antibody, wherein the antibody comprises an HVR-H1 comprising the amino acid sequence YSISSGYHWSWI (SEQ ID NO: 23), an HVR-H2 comprising the amino acid sequence LARIDWDDDKYYSTSLKSRL (SEQ ID NO:35), an HVR-H3 comprising the amino acid sequence ARSYVYFDY (SEQ ID NO: 45), an HVR-L1 comprising the amino acid sequence RASQSVRGRFLA (SEQ ID NO: 58), an HVR-L2 comprising the amino acid sequence DASNRATGI (SEQ ID NO: 66), and an HVR-L3 comprising the amino acid sequence YCQQSSSWPPT (SEQ ID NO: 75). Specifically claim 28 in ‘036 recites a method of reducing size of a solid tumor in a subject in need thereof, wherein the solid tumor has a size of about 400-1000 mm 3 , the method comprising administering to the subject an effective amount of the same CTLA4 antibody. T he anti-CTLA4 antibody recited in claim 21 of ‘036 comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 87, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 100, which six CDR sequences and heavy and light chain variable regions are 100% identical to those in the instant application (See claims 1, 21, 27-28 ). In instant independent claim 47, a method of treating a cancer in a subject, comprising administering to the subject an effective amount of an anti-CTLA4 antibody, wherein the subject is resistant to or has relapsed from a prior therapy, wherein the prior therapy is an inhibitor of CT L A4, PD- 1 , or a PD- 1 ligand, wherein the anti-CTLA4 antibody comprises an HVR-H1 comprising the amino acid sequence of SEQ ID NO: 23, an HVR-H2 comprising the amino acid sequence of SEQ ID NO: 35, an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 45, an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 58, an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 66, and an HVR-L3 comprising the amino acid sequence of SEQ ID NO: 75, is claimed. In instant independent claim 52, a method of treating a cancer in a subject, comprising administering to the subject an effective amount of an anti-CTLA4 antibody, wherein the anti-CTLA4 antibody is administered at a dose of from 3 mg/kg to 20 mg/kg, wherein the anti-CTLA4 antibody is administered about once every three weeks, and wherein the anti-CTLA4 antibody comprises an HVR-H1 comprising the amino acid sequence of SEQ ID NO: 23, an HVR-H2 comprising the amino acid sequence of SEQ ID NO: 35, an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 45, an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 58, an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 66, and an HVR-L3 comprising the amino acid sequence of SEQ ID NO: 75, is claimed. Instant independent claims 47 and 52 are a species of claims 27- 28 in the ‘0 3 6 patent and encompass subject matter to which the claims in the ‘0 3 6 patent are generic because a method as recited in instant claims 47-66 is encompassed by the method of claims 27- 28 of the ‘0 3 6 patent, and in both applications the same antibody is administered to treat the same condition. In instant claim 47, a subpopulation of cancer patients is administered the same antibody for the same condition. However, the instant claims are obvious from the patented claims because the instant claims are directed to one specific embodiment encompassed by the patented claims. The instant method is included in the method claims of the patent and both sets of claims are of overlapping scope. It would have been obvious to one of ordinary skill in the art at the time the present invention was made, that a method as recited in the instant claims, was included in the method as recited in the patented claims. Furthermore, it would have been obvious to o ne of ordinary skill in the art , in this case , a n oncologist , to monitor the dosage and have the motivation and ability to optimize the best administration dosage and schedule of administration , to obtain the best and efficacious course of treatment. Times of dosage, like dosage of administration, are “result effected variables”, that have an effect on the outcome of a method. Furthermore, s uch determination would have been well-within the skill set of one of ordinary skill in the art . Furthermore, the person of ordinary skill in the art, in this case an oncologist, would have expected success for reducing tumor volume where the subject was resistant or has relapsed from a prior therapy because the method of the instant claims was already being successfully used at the time the instant invention was made. Therefore, the claimed invention is obvious over the claims of ‘0 3 6. The patented claims if infringed upon would also result in infringement of the claims of the instant application. Allowance of the pending claims, therefore, would have the effect of extending the enforceable life of the allowed claims beyond the statutory limit. Conclusion No claim is allowed. Claims 47-66, are rejected. Advisory Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Value for firstName-middleName-lastName?" \* MERGEFORMAT PREMA MARIA MERTZ whose telephone number is FILLIN "Insert your individual area code and phone number." \* MERGEFORMAT (571)272-0876 . The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "Insert your SPE’s name." \* MERGEFORMAT VANESSA FORD , can be reached at telephone number FILLIN "Insert your SPE’s area code and phone number." \* MERGEFORMAT 571-272-0857 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form. /PREMA M MERTZ/ Primary Examiner, Art Unit 1674
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Prosecution Timeline

Sep 28, 2023
Application Filed
Mar 03, 2026
Examiner Interview (Telephonic)
Mar 04, 2026
Non-Final Rejection — §103, §112, §DP (current)

Precedent Cases

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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
72%
Grant Probability
99%
With Interview (+35.6%)
2y 10m
Median Time to Grant
Low
PTA Risk
Based on 754 resolved cases by this examiner. Grant probability derived from career allow rate.

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