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 .
DETAILED ACTION
This office action is in response to the Response to Election/Restriction filed 06 August 2026 for application 18/705,375 filed 26 April 2024, 371 of PCT/CA2022/051650 filed 08 November 2022, with PRO 63/341,380 filed 12 May 2022 and PRO 63/276,976 filed 08 November 2021. Claims 3-4, 6, 8, 16, 20 and 22 are amended. Claims 17, 19 and 21 are canceled. Currently, claims 1-16, 18, 20 and 22 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted via third-party submission on 11 April 2025 was filed after the mailing date of the application on 26 April 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election of Group II without traverse in the response filed 06 August 2026 is acknowledged.
Claims 1-9, 12-16, 18, 20, and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06 August 2026.
Specification
The abstract of the disclosure is objected to because the abstract consists of more than 150 words. 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).
Drawings
The drawings are objected to because some of the images are not well-resolved (i.e. too blurry). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 non-obviousness.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over A. I. Kassis (Methods of detecting neurological or neuropsychiatric diseases or conditions, US 2013/0178375 A1, 2013) in view of Toden et al. (Noninvasive characterization of Alzheimer’s disease by circulating, cell-free messenger RNA next-generation sequencing, Sci. Adv. 2020, 6, eabb1654).
Kassis discloses methods of using phagocytic cells in the diagnosis, prognosis or monitoring of neurological or neuropsychiatric diseases or conditions through identification of markers (abstract), these markers being embodied by several entities including RNA (para. 0025) and mRNA (para. 0082), neurological diseases and conditions including head trauma, Alzheimer’s disease, and depression (para. 0070), with useful markers disclosed in para. 0133, with multiple described methods assessing disease risk, prognosing the disease, monitoring progression, assessing efficacy of treatment, or identifying a compound capable of ameliorating or treating the disease or condition (para. 0063) with several example methods (para. 0140-0177).
This is improved upon and reinforced by Toden who teaches a non-invasive means (i.e. non-biopsy) to analyze cell-free messenger RNA to identify dysregulated genes in patients with Alzheimer’s disease. In their work, they identify 2591 genes differentially expressed between Alzheimer’s disease patients and non-cognitive control patients with similar age distributions (pg. 2 – Results). This is broadly summarized in Fig. 2C (pg. 3) where the top ten up-regulated and down-regulated pathways are listed including those involved in mitochondrial dysfunction, inflammasome pathway, IL-8 signaling, G protein-coupled receptor signaling, etc. They conclude that this method of detection, developing non-invasive tools to evaluate molecular dysregulations in patients with Alzheimer’s disease will improve the outcomes of clinical trials and drug development, including those targeting alternative pathways such as inflammation and mitochondrial dysfunction (pg. 6 – left col.).
As such, it would be prima facie obvious, to the person of ordinary skill in the art, before the effective filing date, to use the disclosure by Kassis describing testing biomarkers, including mRNA, from phagocytic cells as a means to evaluating the onset, progression, and treatment of neurological diseases and conditions, and possibly modify with the teachings of Toden who describes using cell-free messenger RNA to evaluate changes in gene expression to determine presence of, progression, and changes within patients suffering from Alzheimer’s disease, a species of the genus neurodegenerative diseases.
Regarding the limitations of claim 11 are met as Toden discloses the genes identified include IL-6, IL-8, IL-12, TGF-β1, IL-4, IL-10, CCR3, GRIN2B, GRIN2A, TLR1, VDAC3, GDNF and NGF (Supplemental 1).
Summary
Claims 10-11 are rejected under 35 U.S.C. 103. Claims 1-9, 12-16, 18, 20 and 22 are withdrawn.
Conclusion
Claims 10-11 are rejected. Claims 1-9, 12-16, 18, 20 and 22 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allen Chao whose telephone number is (571)272-7001. The examiner can normally be reached Monday - Friday 0700-1300.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLEN CHAO/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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