DETAILED ACTION
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.
Claims 1-8, 11, 15, 16, 19 and 20 have been withdrawn.
Claims 9, 10, 12-14, 17 and 18 are currently under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. §119 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/045482, fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application.
Claims 9 is drawn to a method of treating a human subject with cancer comprising providing a chemokine and/or cytokine-containing sample from said subject, assessing two or more chemokines and/or cytokines levels in said sample, wherein the two or more chemokines and/or cytokines comprise CCL17 and one or more chemokines and/or cytokines. However, the specification of Application No. 17/045482 only disclose that CCL17 is an inflammatory chemokine and does not disclose that CCL17 may be used to determine the treatment regimen listed in claim 9 (page 23, line 22 to page 24, line 5).
Thus, claims 9, 10, 12-14, 17 and 18 are hereby assigned the priority date of December 7, 2022, the filing date of the present application.
Objections to Claims
The objections to the specification are withdrawn in view of Applicant’s arguments and the amendments to claim 9.
35 USC § 103 rejections withdrawn
The rejection of claims 9, 10, 12-14, 17 and 18 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) are withdrawn in view of Applicant’s arguments and amendments to claim 9.
Double Patenting rejections withdrawn
The rejections of claim 9, 10, 12-14, 17 and 18 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 are withdrawn in view of Applicant’s amendments to claim 9.
NEW REJECTIONS: Based on the Amendment
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) in further view of Suresh et al (J Clin Invest 129:4305-4315, 2019).
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 CCL17 and 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
Neither Wassmann nor Gill disclose assessing levels of CCL17.
Suresh disclose increased levels of CCL17 in checkpoint inhibitor induced pneumonitis (page 4308 2nd column to page 4309, 1st column).
One of ordinary skill in the art would have been motivated to apply Suresh’s disclosure that CCL17 was elevated in a checkpoint inhibitor induced pneumonitis to Wassmann and Gill’s 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 because Wassmann, Gill and Suresh all disclose measuring elevated levels of cytokines during immune-related adverse events. It would have been prima facie obvious to combine Wassmann and Gill’s 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 with Suresh’s disclosure that CCL17 was elevated in a checkpoint inhibitor induced pneumonitis 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 and CCL17 in said sample, and treating said subject with a non-immunotherapy cancer treatment when IL8/CXCL8 and CCL17 levels are found to be above populational average. One of ordinary skill in the art would have had a reasonable expectation of success given that both IL8/CXCL8 and CCL17 have been found to be elevated in immune-related adverse events.
Summary
Claims 9, 10, 12-14, 17 and 18 stand rejected
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/MARK HALVORSON/Primary Examiner, Art Unit 1646
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