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 .
Claims 1-20 are pending.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on December 29, 2025 is acknowledged. Applicant’s election without traverse of the subcombination IL-8/CXCL8 in the reply filed on December 29, 2025 is acknowledged. The limitation “one or more” has been interpreted as being synonymous to the limitation “or any combination thereof”.
Applicant’s election without traverse of the species of chemotherapy, checkpoint inhibitor therapy, is acknowledged.
Claims 1-8, 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claims 11, 15 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species.
Claims 9, 10, 12-14, 17 and 18 are under examination.
Claim Objections
Claims 9, 10, 12-14, 17 and 18 are objected to because of the following informalities:
The claims are objected to as being drawn to non-elected inventions. Claim 9 recites various non-elected chemokines and cytokines. The non-elected chemokines and cytokines should be listed as dependent claims from claims listing the elected chemokine IL-8.
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 of this title, 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 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 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) 9, 10, 12-14, 17 and 18 is/are rejected under 35 U.S.C. 103 as obvious over Wassmann (US 2020/0190585, published June 18, 2020, effective filing date February 15, 2017, IDS, IDS, cited previously) in view of Gill et al (US 2019/0336504, published November 7, 2019, filed July 14, 2017, IDS).
The claims are drawn to a method of treating a human subject with cancer comprising providing a chemokine- and or cytokine-containing sample from said subject, assessing levels of IL8/CXCL8 in said sample, and treating said subject with a cancer immunotherapy when IL8/CXCL8 levels are found to be below populational average, and a non-immunotherapy cancer treatment when IL8/CXCL8 levels are found to be above populational average.
Wassmann disclose using blood tests for determining levels of cytokines and /or chemokines, including IL-8 (CXCL8) to predict whether to administer a checkpoint inhibitor antibody to the patients (paragraphs 91-120, 126-130, 171; 206-241 Table 2, page 12). Wassmann disclose administering other chemotherapeutic agents to patients predicted to have an adverse reaction to immunotherapy (Id). Wassmann disclose monitoring patients to detect risk of adverse reactions to immunotherapy (Id). Wassmann disclose that these immune-related adverse events can be local or systemic adverse reactions may involve the gut, skin, endocrine glands, liver, or lung, and can potentially affect any other organs or tissue. (paragraph 93). Wassmann disclose classifying subjects into categories based on severity of colitis (paragraphs 406-433). Wassmann disclose using an ELISA for determining levels of cytokines and /or chemokines in a blood sample (paragraph 200). Wassmann disclose receiving the history of autoimmune disease for patients (paragraph 225, 261). Wassmann discloses that the subject may have been previously treated with any one or more therapeutic treatments for cancer, alone or in combination with a surgical procedure for removing cancerous tissue (paragraph 114).
Gill disclose that that several cytokines are elevated in immune-related adverse events associated with immunotherapy, including IL-8 (paragraphs 73-75). Gill further disclose treatment with IL-6 inhibitors (paragraph 66).
One of ordinary skill in the art would be motivated to apply Gill’s disclosure that IL-6, IL-8 and IP-10 are elevated in elevated in immune-related adverse events associated with immunotherapy to Wassmann’s method determining levels of cytokines and /or chemokines, including IL-8 (CXCL8) to predict whether to administer a checkpoint inhibitor antibody to the patients because both Wassmann and Gill disclose measuring IL-6, IL-8 and IP-10 in immune-related adverse events associated with immunotherapy. Wassmann disclose tests for determining levels of cytokines and /or chemokines, including IL-8 (CXCL8) to predict whether to administer a checkpoint inhibitor antibody to the patients while Gill’s discloses that IL-8 is elevated in elevated in immune-related adverse events associated with immunotherapy. It would have been prima facie obvious to combine Wassmann’s method determining levels of cytokines and /or chemokines, including IL-8 (CXCL8) to predict whether to administer a checkpoint inhibitor antibody to the patients with Gill’s discloses that IL-8 is elevated in immune-related adverse events associated with immunotherapy to have a method of treating a human subject with cancer comprising providing a chemokine- and or cytokine-containing sample from said subject, assessing levels of IL8/CXCL8 in said sample, and treating said subject with a cancer immunotherapy when IL8/CXCL8 levels are found to be below populational average, and a non-immunotherapy cancer treatment when IL8/CXCL8 levels are found to be above populational average
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 9, 10, 12-14, 17 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 15, 16, 42, 43, 49, 51and 86 of copending Application No. 17/045482 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Application No. 17/045482 are drawn to a method of treating a human subject to mitigate or prevent immunotherapy toxicity, the method comprising (a) providing a chemokine- and/or cytokine-containing sample from the subject prior to treatment with an immunotherapy; (b) assessing chemokine and/or cytokine levels in the sample provided prior to treatment wherein the one or more chemokines and/or cytokines comprise IL-8/CXCL8, MIG/CXCL9, and IP-10/CXCL10. Thus, both the present claims and the claims of Application No. 17/045482 are drawn to methods of treating a human subject to mitigate or prevent immunotherapy toxicity, comprising providing a chemokine- and/or cytokine-containing sample from the subject and assessing chemokine and/or cytokine levels in the sample, including IL-8/CXCL8.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Summary
No claims allowed.
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/MARK HALVORSON/Primary Examiner, Art Unit 1646