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 .
Applicant filed a response to the Non-Final Action of 5/11/2026 on 8/10/2026. Claims 1, 4, 7, 17, 20 are amended. Claims 2, 6, 10, 11, 16, 19, 21, 24 are canceled.
Claims 1, 3-5, 7-9, 12-15, 17, 18, 20-23 are pending and under consideration.
Withdrawn Rejections
112d:
Claim 4 was rejected under 112d for failing to further limit. Applicant has canceled claim 4. The rejection as it applies to claim 4 is withdrawn.
112b:
Claims 12-15 were rejected as being indefinite. Claim 12 lacked antecedent basis for reciting “the paclitaxel” and “the cisplatin” in claim 1. Claims 13-15 depended on claim 12 and were included in the rejection. Applicant amended claim 1 to include “paclitaxel” and “cisplatin.” The rejection as it applies to claims 12-15 is withdrawn.
112a (Enablement):
Claims 1, 3-15, 17, 18, 20, 22-24 were rejected for the claims reciting “prevention” of esophageal cancer. Applicant has amended claim 1 such that the claim recites only treatment of cancer. The rejection as it applies to claims 1, 3-5, 7-9, 12-15, 17, 18, 20-23 is withdrawn. The rejection as it applies to claims 6, 10, 11, 24 is withdrawn as the claims are canceled.
102:
The rejection of claims 1, 10 as being anticipated by NCT03189719 is withdrawn as applicant has amended the claims to specifically indicate cisplatin and paclitaxel and an antibody comprising light chain of CDRs SEQ ID NOs: 1-3 and heavy chain of CDRs SEQ ID NOs: 4-6.
The rejection of claims 1, 10 as being anticipated by NCT03691090 is withdrawn as applicant has amended the claims to specifically indicate cisplatin and paclitaxel and an antibody comprising light chain of CDRs SEQ ID NOs: 1-3 and heavy chain of CDRs SEQ ID NOs: 4-6.
The rejection of claims 1, 10, 12, 13, 24 as being anticipated by CN 110859959 is withdrawn as applicant has amended the claims to specifically indicate cisplatin and paclitaxel and an antibody comprising light chain of CDRs SEQ ID NOs: 1-3 and heavy chain of CDRs SEQ ID NOs: 4-6.
The rejection of claims 1, 3, 4, 6-9 as being anticipated by WO 2020211804 (US20220154296 equivalent reference used for citations) is withdrawn as applicant has amended the claims to specifically indicate cisplatin and paclitaxel and an antibody comprising light chain of CDRs SEQ ID NOs: 1-3 and heavy chain of CDRs SEQ ID NOs: 4-6.
103:
Claims 1, 3-15, 17, 18, 20, 22-24 were rejected as being obvious of NCT03189719, NCT03691090, CN110859959, and WO2020211804 (US20220154296 equivalent reference). The rejection as it applies to claims 1, 3-5, 7-9, 12-15, 17, 18, 20-23 is withdrawn in favor of the new rejection, below. The rejection of claims 6, 10, 11, 24 is withdrawn as the claims are canceled.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15, 20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites, “in one embodiment.” It is unclear whether or not the limitations that follow the phrase are a required limitation or not.
Claim 20 recites, “e.g.” This is exemplary claim language and it is unclear whether or not the limitations that follow the e.g. are required or not (see MPEP 2173.05d).
Claim Rejections - 35 USC § 102
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.
Claims 1, 3, 4, 7-9, 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clinicaltrials.gov NCT03829969 (‘969), version 4, entered 2019-09-28.
Regarding claims 1 and 17, ‘969 teaches a drug trial on the treatment of Esophageal Squamous Cell Carcinoma with Toripalimab or Placebo with Paclitaxel and Cisplatin (see Brief Title, page 5 of printout). It is noted that Toripalimab is an antibody that has the 6 CDRs recited in claim 1 (i.e., SEQ ID NOs: 1-3 are CDRs in the light chain and SEQ ID NOs: 4-6 are CDRs in the heavy chain). It is also noted that Toripalimab is known as JS001.
Regarding claim 3, ‘969 teach that about 55% of all the subjects enrolled, i.e., 275 subjects, are expected not to be the carriers of 11q13 region amplification. This means that 45% of the patients in the study have the 11q13 region amplification. A snag-it of the Brief summary from ‘969, version 4 is attached here. The printout generated by the computer is incomplete.
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Regarding claim 4, wherein the esophageal cancer has PD-L1 expression of <1% or a PD-L1 expression of ≥ 1%, the claim reads on esophageal cancer that has any or no expression of PD-L1. ‘969 does not indicate any study of PD-L1 levels, but 0 expression of PD-L1 would anticipate the claims.
Regarding claims 7-9, SEQ ID NOs: 7 and 8 and SEQ ID NOs: 9 and 10 correspond to Toripalimab.
Claims 1, 3, 4, 7-9, 12, 17, 18, 20, 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCT03985670 (‘670), version 2, entered 2019-12-10 as evidenced by Xing et al., 2020, “A phase II, single-centre trial of neoadjuvant toripalimab plus chemotherapy in locally advanced esophageal squamous cell carcinoma,” J Thorac Dis 12(11):6861-6867.
Regarding claims 1, 17, ‘670 teaches a study of treating patients with local advanced esophageal squamous cell carcinoma who receive two cycles of neoadjuvant chemotherapy and PD-1 antibody in the same day or chemotherapy followed by PD-1 antibody and then surgery (‘670 under Study Design). Specifically, ‘670 teaches that patients were administered a) toripalimab 240 mg d1, paclitaxel 150-175 mg/m2 d1, and cisplatin 70-75 ml/m2 d1 or b) paclitaxel 150-175 mg/m2 d1, cisplatin 70-75 mg/ml2 d1, and toripalimab 240 mg d3. It is noted that toripalimab is an antibody which comprises CDRs of SEQ ID NOs: 1-3 in the light chain and SEQ ID NOs: 4-6 in the heavy chain. It is also noted that “teripalimab” in ‘670 appears to be a misspelling of toripalimab, as Xing et al. discusses the use of toripalimab used in ‘690, see Title of Xing et al., for example.
Regarding claim 3 being drawn to esophageal cancer patients having a gene amplification of chromosome 11q13, ‘670 does not teach that esophageal cancer patients have a gene amplification of 11q13. However, 45% of the population of esophageal cancer patients has gene amplification of 11q13. ‘969 teach that about 55% of all the subjects enrolled, i.e., 275 subjects, are expected not to be the carriers of 11q13 region amplification. This means that 45% of the patients in the study have the 11q13 region amplification. It is noted that a Snag-it of the ‘969 v. 4, Brief Summary is provided as the version 4 printout has deletions in the text.
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Regarding claim 4, wherein the esophageal cancer has PD-L1 expression of <1% or a PD-L1 expression of ≥ 1%, the claim reads on esophageal cancer that has any or no expression of PD-L1. ‘969 does not indicate any study of PD-L1 levels, but 0 expression of PD-L1 would anticipate the claims.
Regarding claims 7-9, SEQ ID NOs: 7 and 8 and SEQ ID NOs: 9 and 10 correspond to toripalimab.
Regarding claims 12, 18, 20, 22 ‘670 teaches that toripalimab was administered at 240 mg, paclitaxel at 150-175 mg/m2, and cisplatin at 70-75 ml/m2.
Claims 1, 3, 4, 7-9, 12-15, 17, 18, 20, 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xing et al., 2020, “A phase II, single-centre trial of neoadjuvant toripalimab plus chemotherapy in locally advanced esophageal squamous cell carcinoma,” J Thorac Dis 12(11):6861-6867, as evidenced by NCT03829969 (‘969), version 4, entered 2019-09-28.
Regarding claims 1, 17, Xing et al. teach patients with locally advanced esophageal squamous cell carcinoma were administered a) toripalimab 240 mg d1, paclitaxel 150-175 mg/m2 d1, and cisplatin 70-75 ml/m2 d1 or b) paclitaxel 150-175 mg/m2 d1, cisplatin 70-75 mg/ml2 d1, and toripalimab 240 mg d3. Xing et al. also teach that both treatment arms comprise cycles that last 3 weeks and the cycles were repeated twice. It is noted that toripalimab is an antibody which comprises the 6 CDRs recited in claim 1 (i.e., SEQ ID NOs: 1-3 are CDRs in the light chain and SEQ ID NOs: 4-6 are CDRs in the heavy chain)(see Xing et al. title and page 6864, 2nd col. Under Treatment regimens).
Regarding claim 3 being drawn to esophageal cancer patients having a gene amplification of chromosome 11q13, ‘670 does not teach that esophageal cancer patients have a gene amplification of 11q13. However, 45% of the population of esophageal cancer patients has gene amplification of 11q13. ‘969 teach that about 55% of all the subjects enrolled, i.e., 275 subjects, are expected not to be the carriers of 11q13 region amplification. This means that 45% of the patients in the study have the 11q13 region amplification. It is noted that a Snag-it of the ‘969 v. 4, Brief Summary is provided as the version 4 printout has deletions in the text.
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Regarding claim 4, wherein the esophageal cancer has PD-L1 expression of <1% or a PD-L1 expression of ≥ 1%, the claim reads on esophageal cancer that has any or no expression of PD-L1. ‘969 does not indicate any study of PD-L1 levels, but even 0 expression of PD-L1 would anticipate the claims.
Regarding claims 7-9, SEQ ID NOs: 7 and 8 and SEQ ID NOs: 9 and 10 correspond to toripalimab.
Regarding claims 12, 18, 20, 22 ‘670 teaches that toripalimab was administered at 240 mg, paclitaxel at 150-175 mg/m2, and cisplatin at 70-75 ml/m2.
Regarding claims 13-15, 18, 20 being drawn to the timing of dosages, Xing et al. teach that the patients were either administered a) toripalimab 240 mg d1, paclitaxel 150-175 mg/m2 d1, and cisplatin 70-75 ml/m2 d1 or b) paclitaxel 150-175 mg/m2 d1, cisplatin 70-75 mg/ml2 d1, and toripalimab 240 mg d3. Xing et al. also teach that both treatment arms comprise cycles that last 3 weeks and the cycles were repeated twice.
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.
Claims 1, 3-5, 7-9, 12-15, 17, 18, 20, 22, 23 are rejected under 35 U.S.C. 103 as being unpatentable over NCT03985670 (‘670), version 2, entered 2019-12-10 in view of Zhang et al., 2008, “A phase II trial of paclitaxel and cisplatin in patients with advanced squamous-cell carcinoma of the esophagus,” 31(1): 29-33, NCT02915432 (‘432) version 13, 2019-10-22, Yuan et al., 2020, “The prognostic value of tumor mutational burden and immune cell infiltration in esophageal cancer patients with or without radiotherapy,“ Aging, 12: 4603-4616, Heeren et al., 2019, “Neoadjuvant cisplatin and paclitaxel modulate tumor-infiltrating T cells in patients with cervical cancer,” Cancer Immunology, Immunotherapy, 68: 1759-1767.
Regarding claims 1, 17, ‘670 teaches a study of treating patients with local advanced esophageal squamous cell carcinoma who receive two cycles of neoadjuvant chemotherapy and PD-1 antibody in the same day or chemotherapy followed by PD-1 antibody and then surgery (‘670 under Study Design). ‘670 teaches that patients were administered a) toripalimab 240 mg d1, paclitaxel 150-175 mg/m2 d1, and cisplatin 70-75 ml/m2 d1 or b) paclitaxel 150-175 mg/m2 d1, cisplatin 70-75 mg/ml2 d1, and toripalimab 240 mg d3. It is noted that toripalimab is an antibody which comprises CDRs of SEQ ID NOs: 1-3 in the light chain and SEQ ID NOs: 4-6 in the heavy chain. It is also noted that “teripalimab” in ‘670 appears to be a misspelling of toripalimab, as Xing et al. discusses the use of toripalimab used in ‘690, see Title of Xing et al., for example.
However, ‘670 does not teach the cycles (number of rounds) that the drugs are administered (i.e. instant claims 13-15).
Zhang et al. teach treatment of advanced squamous-cell carcinoma of the esophagus with paclitaxel and cisplatin (Zhang et al., title). Patients received 175 mg/m2 infusion of paclitaxel and 75 mg/m2 of cisplatin on day 1. Treatment was repeated every 21 days (Zhang et al., page 30, 1st col. Under Treatment Plan, Chemotherapy Treatment). Zhang et al. teach that patients completed 1 to 6 cycles of paclitaxel and cisplatin (Zhang et al., page 31, 2nd col. Under Response to Therapy). Zhang et al. teach that paclitaxel and cisplatin is a promising treatment for squamous-cell carcinoma of the esophagus. The toxicity of this regimen is within an acceptable range (Zhang et al., abstract).
‘432 teach that subjects in cohorts 5-8 will receive first-line chemotherapy combined with JS001 (toripalimab) 240mg or 360 mg once every 3 weeks (Q3W). JS001 can be administered after the end of chemotherapy until the absence of further benefits judged by the investigator, disease progression, occurrence of intolerable toxicity, investigator’s decision, and withdrawal of informed consent by the subject or death (‘432, page 7, under Study Treatment).
It would have been obvious for an artisan to take the take the combination of paclitaxel, cisplatin, and toripalimab taught by ‘670 and to administer them as: 175 mg/m2 paclitaxel+75mg/m2 cisplatin on day 1, given once every 21 days, and 3mg/kg of toripalimab given Q3W as taught by Zhang et al. and ‘432. One would have used these doses and regimens in ‘670 because Zhang et al. and ‘432 teach that the doses that were used resulted in promising treatment.
Regarding claims 5 and 23, wherein the claims are drawn to low tumor mutation burden (low TMB) (e.g. less than 6 mutations/million base pairs, claim 23), the art teaches that the combination of paclitaxel and cisplatin and PD-1/PD-L1 axis therapy would be beneficial for patients with low TMB. Yuan et al. teach that there is a relationship between tumor mutational burden (TMB) and carcinogenesis and therapeutic efficacy in esophageal cancer. Yuan et al.’s study aimed to explore the genomic landscape and the correlation between TMB and immune cell infiltration in EC patients with or without radiotherapy. Yuan et al. teach that especially for patients who did not receive radiotherapy, the prognosis of TMB-high (TMB-H) was significantly poorer than that of TMB-low (TMB-L) patients which might result from the different regulatory T cell infiltration. (Yuan et al., abstract).
Heeren et al. teach that treatment of cervical cancer patients with cisplatin and paclitaxel reduced the number of proliferating regulatory T cells and increased rates of cytotoxic CD8+ T cells. No effect was observed on the number of tumor-infiltrating T cells in the cervical tumor microenvironment after treatment with cisplatin only (Heeren et al., abstract). Heeren et al. teach that their observations suggest that the combination regimen has more potential to induce immunogenic tumor cell death and release NACT-induced tumor antigens that are taken up by the innate immune system, resulting in tumor-specific CD8+ T-cell activation and expansion. Heenan et al. indicate that the CD8+ T cell response resulting from the combination was synergistic (Heeren et al., page 1762, 2nd col., 2nd parag. under Discussion). Heenan et al. also teach an increase in checkpoint molecules PD-1 and PD-L1 in cervical tumor tissue from patients previously treated with neoadjuvant therapy (NCAT) (Heenan et al., page 1765, 1st col., 3rd parag.).
It would have been obvious for an artisan to administer paclitaxel and cisplatin to a HMB-L cancer patient in order to arrive a synergistic effect of reducing regulatory T cell populations (which interfere with immunotherapy). One would have also introduced an anti-PD1/PD-L1 axis therapy (such as toripalimab) to block the interaction between PD-1 and PD-L1 (that results in immune cell exhaustion) following administration of paclitaxel and cisplatin. There would have been reasonable expectation of success as Yuan et al. teach a relationship between HBM and regulatory T cells, Heeren et al. teach a relationship between regulatory T cells, cisplatin and paclitaxel, PD-1/PD-L1 expression levels, and success in therapy, and ‘670 for teaching the combination of cisplatin, paclitaxel, and toripalimab for treatment in esophageal cancer.
Response to Arguments
Applicant's arguments filed 8/10/2026 have been fully considered but they are not persuasive. It is noted that all rejections from the action of 5/11/2026 have been withdrawn. However, applicant raises the issue of unexpected results (page 13 of applicant’s response, 8/10/2026).
Applicant indicates that Example 1 and Figure 1 show that the overall survival (OS) for the treatment group treated with the claimed combination of anti-PD-1 antibody with the specific CDRs described in claim 1 (JS001, toripalimab) in combination with cisplatin and paclitaxel was 17 months, while the median OS for the control group treated with placebo in combination with the TP regimen was 11 months (applicant’s response, page 13). In response this is not persuasive. As indicated above, Heeren et al. teach that co-administration of paclitaxel and cisplatin work synergistically to induce immunogenic cell death and help release NACT-induced tumor antigens that are taken up by the innate immune system. Thus, the OS rates taught in the specification are not unexpected.
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.
Claims 1, 3-5, 7-9, 12-15, 17, 18, 20-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10815302 (‘302 )in view of NCT03985670 (‘670), version 2, entered 2019-12-10.
Both sets of claims overlap in that the antibody used in the instant case and ‘302 is toripalumab (SEQ ID NOs: 35 and 37 in claim 5 of ‘302 are the heavy and light chain variable regions of toripalumab). ‘302’s claims are not drawn to any method of use.
‘670 teaches a study of treating patients with local advanced esophageal squamous cell carcinoma who receive two cycles of neoadjuvant chemotherapy and PD-1 antibody in the same day or chemotherapy followed by PD-1 antibody and then surgery (‘670 under Study Design). ‘670 teaches that patients were administered a) toripalimab 240 mg d1, paclitaxel 150-175 mg/m2 d1, and cisplatin 70-75 ml/m2 d1 or b) paclitaxel 150-175 mg/m2 d1, cisplatin 70-75 mg/ml2 d1, and toripalimab 240 mg d3. It is noted that toripalimab is an antibody which comprises CDRs of SEQ ID NOs: 1-3 in the light chain and SEQ ID NOs: 4-6 in the heavy chain.
Thus, at the time the invention was made, ‘670 teaches that one use of the ‘302 antibody was in treatment of esophageal cancer.
Claims 1, 3-5, 7-9, 12-15, 17, 18, 20-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22, 28-35, 41-43 of copending Application No.17604058 (‘058)(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims overlap in being drawn to esophageal squamous cell carcinoma treated with toripalumab (SEQ ID NOs: 1-3 in the light chain and SEQ ID NOs: 4-6 in the heavy chain recited in claim 22 ‘058). Both sets of claims overlap in dosages and timing of administration.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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