CTNF 18/707,062 CTNF 98188 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 Rejections - 35 USC § 101 07-04-01 AIA 07-04 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-3, 6-9, 16-17 and 54-56 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method of selecting a subject for treatment with a compound of Formula I, comprising measuring CD14 + CD16 + myeloid cells compared to baseline. The claims are evaluated below using the “Subject Matter Eligibility Test For Products and Processes” flow chart as is shown in MPEP § 2106 III. Step1: Is the claim to a process, machine, manufacture or composition of matter? The claims are drawn to a process claim Step 2A Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon? Yes, claim 1 recites an abstract of idea of identifying and selecting a subject for treatment with a compound of Formula I, comprising measuring CD14 + CD16 + myeloid cells compared to baseline of a healthy individual. Step 2A Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? Claims 1-3, 6-9, 16-17 and 54-56 recites additional elements of the subject being at risk of developing neuroinflammation, have a family history of neurodegenerative disease and at least 40 years of age. The limitations fail to meaningfully limit the claims with the administration steps of collecting data and analyzing the data, thus the limitations do not integrate the judicial exception into a practical application therefore directing the claim to judicial exception. Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No, the additional limitations in claims 2-3, 6-7, 9, 16-17 and 54-56 does not add an inventive step and does fails to amount to significantly more that judicial exception, the claims merely recite well known steps in the art collecting and analyzing data as stated in MPEP 2106.05(d): The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner ( e.g., at a high level of generality) or as insignificant extra-solution activity: i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017). Claim Rejections - 35 USC § 112 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 07-31-02 AIA Claim s 1, 24 and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claim 24, which depends on claim 1, recites a patient which is at risk of developing, neuroinflammation and/or a neurodegenerative disease. Applicants’ specification specifically addresses patients with ALS that has overexpression of CD14+CD16+ inflammatory phenotype of circulating myeloid cells and fails to suggest or express other neurodegenerative diseases with overexpression of CD14+CD16+ inflammatory phenotype of circulating myeloid cells. Thus, Applicant is not enabled for the limitations of the claim. Claim 32 recites treating a subject who has an inflammatory phenotype or circulating myeloid cells in which applicants’ specification reads to CD14+CD16+ inflammatory phenotype of circulating myeloid cells in ALS customers and not the broad scope of any inflammatory phenotype or circulating myeloid cells from claims limitations. Thus, Applicant is not enabled for the limitations of the claim. In terms of applicants’ teachings of overexpression of CD14+CD16+ inflammatory phenotype of circulating myeloid cells in patients with ALS, Yoles et al. (WO 2011111043 A1) teaches in contrast to other neurodegenerative diseases such as Alzheimer's disease, no alteration has been observed in the level of the pro-inflammatory monocytes CD14 + /CD16 + cells in blood samples of ALS patients, as shown in Table 1; PNG media_image1.png 138 551 media_image1.png Greyscale (Pg. 10, last para; Pg. 11). Although applicants’ specification provides evidence of increased levels of CD14 + /CD16 + , the teaching of Yoles suggest that not all ALS patients express increased levels of CD14 + /CD16 + . 07-30-02 AIA 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. 07-34-01 Claims 4-5, 28 and 57-59 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. Regarding claim 4, the phrase "administering to the subject who is selected for treatment" renders the claim indefinite because it is unclear what is being treated as the claim, while depending from claim 1, does not recite an alignment, disease or disorder to be treated. Claims 57-59 is equally as indefinite as depending from claim 4, without further limiting or addressing the indefinite nature of the claim. Regarding claim 5, the phrase "sufficient to suppress the inflammatory phenotype of circulating myeloid cells" renders the claim indefinite because it is unclear whether the limitation is intended to be of the CD14 + /CD16 + myeloid cells as per claim 1 or the broader limitation of suppressing the inflammatory phenotype of any and all circulating myeloid cells. Ultimately, the metes and bounds of the claim is unclear. Regarding claim 28, the phrase "a method of treating a subject who has not previously been diagnosed with cognitive impairment, but is at least 40" renders the claim indefinite because it is unclear what is being treated as the claim, while depending from claim 1, does not recite an ailment, disease or disorder to be treated. Ultimately, the metes and bounds of the claim is unclear. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm. 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, Kortney Klinkel can be reached at 571-270-5239. 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. MIKHAIL O'DONNEL. ROBINSON Examiner Art Unit 1627 /MIKHAIL O'DONNEL ROBINSON/ Examiner, Art Unit 1627 /SARAH PIHONAK/ Primary Examiner, Art Unit 1627 Application/Control Number: 18/707,062 Page 2 Art Unit: 1627 Application/Control Number: 18/707,062 Page 3 Art Unit: 1627 Application/Control Number: 18/707,062 Page 4 Art Unit: 1627 Application/Control Number: 18/707,062 Page 5 Art Unit: 1627 Application/Control Number: 18/707,062 Page 6 Art Unit: 1627
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