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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/4/2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of the genes C4, MMP9 and NAIP in the reply filed on 5/20/2025 is acknowledged.
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, 365(c), or 386(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. 120The 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 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. 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. 15/028732, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior application does not mention obtaining a biological sample of extracellular vesicles from a patient and determining an expression level of a cluster of at least three genes from the tables. Furthermore, with regard to the elected species, the previous disclosure does not mention this cluster of three genes. The effective filing date of the instant claims is 6/1/2021.
Claim Rejections - 35 USC § 112
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.
Claim Rejections - 35 USC § 101
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.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 29, 32, 33, 35, 36, 37, 38, 39, 40, 43, 44, 45, 46, and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adaminski 2017, Medical Research Archives, vol. 5, issue 11, November 2017 issue, 13 pages in view of Wijerathne et al. (Communications Biology(2020) 3:613, 11 pages).
Adaminiski et al. teach CD15+ granulocyte-based gene expression clusters for ischemic stroke detection, including a method which employs HT RT-qPCR for detecting CA4, MMP9, and NAIP in CD15+ cells, wherein the expression of these cells is significantly characteristic for acute ischemic stroke (section 2.4 and Table 3). Adaminski et al. teach a method in which this gene cluster was used to differentiate stroke patients from healthy controls (section 3.4).
The “wherein” clause is a statement of an inherent property of the relationship between gene expression and risk of stroke, and there is no further action implied or required by this statement. Further the statement in the preamble “for identifying patients having increased risk for acute ischemic stroke” is a statement of intended use, and the method taught by the reference could be used as intended. Claim 32 further defines the “wherein” clause and does not require any further action.
Regarding claim 33-35 and 40, the reference teaches determining expression levels by HT RT-PCR, including a step of counting the number of cells that were extracted (Section 2.2, 2.4, 2.5). This method inherently meets the limitations of the recited claims.
Adaminski et al. does not teach determining the expression levels of this cluster of three genes in a biological sample of extracellular vesicles from a patient.
Wijerathne teaches that affinity enrichment of extracellular vesicles from plasma reveals mRNA changes associated with acute ischemic stroke. Wijerathne demonstrates the method with 5 markers that had been previously shown to have differential expression in CD8+ blood cells, and teaches “[t]o improve the clinical sensitivity, larger gene panels can be usedalong with enrichment of both CD8(+) and CD15(+) EVs; CD15(+) neutrophils have been identified as a source of mRNA markers for AIS as well (p. 7, Col. 2).”
Regarding claims 36 and 37, Wijerthane teaches that if a patient tests positive for AIS, the patient would be transported to a stroke center for administration of rt-PA therapy (p. 9, second column). The reference teaches that the disclosed method could reflect the physiological perturbation imposed by AIS within three hours of stroke onset and thus provide indications of disease within time constraints imposed by effective rt-PA treatment (p. 7). The reference teaches that the assay required 3.7 hours of processing time (p. 7), and that the time the assay requires is optimizable and could be reduced by as much as 58 minutes by using photocleavable linkers (p. 8).
It would have been prima facie obvious to one having ordinary skill in the art to have modified the method taught by Adaminski so as to have isolated EV from blood of a patient and measured the expression of CA4, MMP9, and NAIP in CD15+ EV. One would have been motivated to make such a modification by the teachings of Wijerathne regarding the benefits of a blood-based test for AIS such as to provide an assay that can operate as a point of care test for early response to AIS (p. 9, 1st column). Furthermore, upon identifying a patient having AIS profile, it would have been obvious to have delivered the rt-PA treatment as quickly as possible.
Response to Remarks
Any rejection not maintained or otherwise addressed was overcome by amendment to the claim 5/4/2026.
Applicant argues against the 103 rejections that rely on Wijeranthe because Wijeranthe is “improperly cited as prior art.” A declaration has been filed.
The declaration is not effective because it does not establish that the disclosure was made by the inventor at least because the declaration does not address the co-author Hupert. Furthermore, the declaration states that the inventors of the instant application are Baird, Adamski, and Soper, and states that Witek did not contribute to the conception of the subject matter presently claimed. This contradicts the filing receipt and the inventor's oath filed 2/2/2022 which both state that Witek is an inventor of the instant application. It is therefore not clear whether Witek is an inventor of any of claims currently under examination.
Clarification is required.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen can be reached at (571)-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/ Primary Examiner, Art Unit 1682
