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 .
Priority
The present application, filed on 04/24/2023, claims priority over U.S. provisional application filed on 05/17/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/26/2025 was filed after the mailing date of the present application on 04/24/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of Claims
Claims 1-10 was amended and filed on 07/10/2023 and are pending and examined under the merits herein.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Krukowski et al., 2016 (Krukowski K, Eijkelkamp N, Laumet G, Hack CE, Li Y, Dougherty PM, Heijnen CJ, Kavelaars A. CD8+ T Cells and Endogenous IL-10 Are Required for Resolution of Chemotherapy-Induced Neuropathic Pain. J Neurosci. 2016 Oct 26;36(43):11074-11083. doi: 10.1523/JNEUROSCI.3708-15.2016, listed in the IDS) and in further view of Engelhardt 2018 (US 2018/0289790 A1, published on 10/11/2018).
Regarding instant claim 1, Krukowski et al., 2016 teaches an immune mechanism of chemotherapy-induced neuropathic pain (CIPN) wherein the activation of CD8+ T cells and induction of IL-10 is required to resolve the CIPN (page 11081, column 1, paragraph 3, “both CD8+ T cells and endogenous IL-10 are required for the resolution of CIPN”). Krukowski et al., 2016 further discloses that the chemotherapeutic causing the CIPN was paclitaxel (page 11074, abstract) and that regulatory CD8+ T cells are required to upregulate IL-10 receptors in the dorsal root ganglia (DRG) during resolution of CIPN and that, in vitro, IL-10 suppresses the paclitaxel-induced spontaneous discharges of DRG neurons directly (page 11081, column 2, paragraph 2).
While Krukowski et al., 2016 teaches CD8+ T cells and IL-10 is required to resolve CIPN, they do not teach an ICOS agonist antibody. Engelhardt 2018 teaches an agonist ICOS antibody that can be used as a therapeutic agent in treating cancer and various conditions caused by cancer which include pain as recited claim 1 and 5 (page 56, example 6, paragraph 0611, “Overall, anti-ICOS monotherapies promoted antitumor activity”, and page 35, column 1, paragraph 0423, “pain”). Engelhard 2018 further teaches that the agonist ICOS antibody induces the cytokine interleukin 10 (IL-10) (page 52, paragraph 0210, “ increases secretion of at least one of IL-10 and IFN-g by Tfh cells in vitro”) as recited in instant claim 3 and activates T cells (page 52, paragraph 0201, “activates at least one primary T lymphocyte, such as a CD4+ effector T (Teff) cell, a follicular helper T (Tfh) cell, and a regulatory T (Treg) cell”).
Therefore, it would have been obvious to the person of ordinary skill in the art to use the agonist ICOS antibody to induce IL-10 and activate T cells such as CD8+ T cells through the ICOS signaling pathway as taught by Engelhardt and the immune mechanism to resolve CIPN as proposed by Krukowski and expect reasonable success at treating chemotherapy induced neuropathic pain.
Regarding instant claim 2 and 4, Krukowski et al., 2016 teaches the pain is neuropathic pain, specifically chemically induced peripheral neuropathy (CIPN) (page 11074, Title).
Regarding instant claim 6, Engelhardt 2018 teaches administering includes intrathecal administration (page 49, paragraph 0161).
Regarding instant claim 7, Krukowski et al., 2016 discloses that the pain in the subject is reduced (page 11080, column 1, paragraph 3, “The results shown in Figure 5A demonstrate that IL-10 relieves CIPN transiently” ).
Regarding instant claims 8, 9 and 10, Kurkowski et al., 2016 teaches the antineoplastic agent is paclitaxel (page 11074, Significance statement, “We identified a novel and critical role for CD8+ T cells and for endogenous IL-10 in recovery from paclitaxel-induced neuropathy in mice”) and that the dorsal root ganglia (DRG) neurons displayed abnormal spontaneous discharges after in vivo exposure to paclitaxel (page 11080, column 1, paragraph 3).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lam Thuy Vi Tran Ho whose telephone number is (571)272-9135. The examiner can normally be reached Monday-Friday 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAM THUY VI TRAN HO/Examiner, Art Unit 1647 /L.T./Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647