CTNF 18/140,344 CTNF 73171 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Status Claims 1-4 are currently pending and under consideration in the instant Office action. Information Disclosure Statement 06-49-06 AIA The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. The information disclosure statements (IDS) submitted on 11 May 2023 and 20 July 2023 have been considered by the examiner. Applicant should note that several documents could not be considered as no copy was provided and no copy could be found in the parent application for consideration. Drawings The drawings which are currently in the instant application are in black and white. While there are no objections to the current drawings, the Brief Description of the Drawings, beginning on page 6 of the specification, is not consistent with the drawings on file because the description references color in multiple figures (see for example Figure1C(ii) which references green, blue and red). These colors are not visible in the drawings and therefore, it is unclear what details are being referenced. If color drawings are required to comprehend what is being depicted, then color drawings should be submitted along with an appropriate petition. If color drawings are not required, then reference to color should be removed from the Brief Description of the Drawings. Specification The abstract of the disclosure is objected to because of the recitation of “ILC2”. This abbreviation should be spelled out in its first usage for clarity. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). 07-29 AIA The disclosure is objected to because of the following informalities: the specification is not compliant with 37 CFR 1.52(a)(1)(iv-v). See, for example, page 5, paragraphs [0024]-[0028]. The specification contains text which is not composed of solid black lines. The text appears gray and upon magnification, it is clear that the text is not composed of solid black lines (see screen shot below). PNG media_image1.png 146 796 media_image1.png Greyscale Legibility includes ability to be photocopied and scanned so that suitable reprints can be made and paper can be electronically reproduced by use of digital imaging and optical character recognition. This requires a high contrast, with black lines and a white background. Gray lines and/or a gray background sharply reduce photo reproduction quality and are not in compliance with 37 CFR 1.52. In order to enhance readability of electronic submissions, the USPTO strongly recommends use of a black colored font for text on a white background . Appropriate correction is required. The use of at least terms Bioinjector™ (page 22 at [0092]), TrueNuclear® (page 32 at [00179]), and EasyStep™ (page 36 at [00196]), which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Applicant should also review the entire specification for compliance with this requirement. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. 07-29 AIA The disclosure is objected to because of the following informalities: Page 33 of the specification at [00186] uses an abbreviation of “Iba-1”. This abbreviation is not defined and it is not clear what the abbreviation stands for. A review of the specification could not find any other reference to “Iba-1” so it does not appear to be defined . Appropriate correction is required. Claim Objections 07-29-01 AIA Claim 3 is objected to because of the following informalities: the claim is grammatically incorrect for improper noun/verb agreement (“activated ILC2s is” should be “activated ILC2s are”) . Appropriate correction is required. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Gadani et al. (J Exp Med. 2017 Feb;214(2):285-296) in view of Seehus et al. (Nature Communications (2017) vol. 8, id. 1900, doi: 10.1038/s41467-017-02023-z) and WO 2012/062930 (Kaya et al.) . Gadani et al. disclose characterization of meningeal type 2 innate lymphocytes (ILC2s) and their response to CNS injury, wherein the ILC2s as a novel cell type resident in the healthy meninges, and are activated after CNS injury such as spinal cord injury (SCI) in an IL-33- dependent manner, producing type 2 cytokines; and that addition of wild-type lung-derived ILC2s into the meningeal space of IL- 33R-/- animals partially improves recovery after SCI; and that the data characterize ILC2s as a novel meningeal cell type that responds to SCI and could lead to new therapeutic insights for neuroinflammatory conditions (abstract, for example). Additionally, Gadani et al. teach the isolated meningeal ILC2s from uninjured versus injured mice (page 288, 1st column, 2ⁿᵈ paragraph); and that lung-derived ILC2s are used for adoptive transfer experiments due to that meningeal ILC2s are sparse; and that ILC2 cytokine production is dependent on IL-33 (page 288, 2ⁿᵈ column, 2ⁿᵈ paragraph). Gadani et al. do not teach genetically modified ILC2 cells for increased IL-10 produciton. Seehus et al. teach activation of ILC2 cells with IL-33 results in ILC2 cells which produce IL-10 and downregulate some pro-inflammatory genes (see abstract and paragraph spanning columns 1-2 of page 3). Seehus et al. teach that an ILC2 cell that can produce IL-10 would be useful for the suppression of allergic and other pathogenic inflammatory immune responses (see page 10, last sentence of Discussion). Kaya et al. teach the genetic modification of a cell for increased IL-10 production (see title). Kaya et al. teach transfecting mRNA encoding IL-10 into the cell to produce a cell that overexpresses IL-10 (see examples and methodology beginning at page 14). Kaya et al. teach that IL-10 is useful for treating inflammation (see abstract). Kaya et al. do not teach genetically modifying an ILC2 cells. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice the method of Gadani et al., which reduces microglial activation, by administering activated type II innate lymphoid cells (ILC2 cells), including isolating and enriching meningeal ILC2 cells, activating the ILC2 cells with IL-33, and using the activated meningeal ILC2 cells to reduce microglial activation as taught by Gadani et al. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ILC2 cells of Gadani et al. by transfecting the cells with mRNA encoding IL-10, as taught by Kaya et al., in order to produce an ILC2 cell that had increased production of IL-10 because Seehus et al. teach that an ILC2 cell that can produce IL-10 is useful for the suppression of allergic and other pathogenic inflammatory immune responses. One of ordinary skill in the art would have had a reasonable expectation of success in transfecting the ILC2 cells of Gadani et al. by the method of Kaya et al. because the instant specification acknowledges that methods for genetically modifying cells for increased production of IL-10 are known in the art (see [0070]). Therefore, the invention as a whole would have been prima facie obvious over the cited references before the effective filing date of the claimed invention. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 8am-4pm. 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) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Christine J Saoud/Primary Examiner, Art Unit 1645 Application/Control Number: 18/140,344 Page 2 Art Unit: 1645 Application/Control Number: 18/140,344 Page 3 Art Unit: 1645 Application/Control Number: 18/140,344 Page 4 Art Unit: 1645 Application/Control Number: 18/140,344 Page 5 Art Unit: 1645 Application/Control Number: 18/140,344 Page 6 Art Unit: 1645
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