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 .
Response to Amendment
Applicant’s amendment filed 10/23/2025 is acknowledged. Claims 1-14 and 27 are newly canceled. Claims 15, 17, 18, 20, 24 and 26 are amended. Claims 15-26 are pending and under examination.
Objections/Rejections Withdrawn
Any rejections over claims 1-14 and 27 are hereby withdrawn in response to Applicant’s cancelation of those claims.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Objections
The objection to claim 26 for minor informalities is withdrawn in response to Applicant’s amendment adding the missing a period (.) at the end of the claim.
Claim Rejections - 35 USC § 101
The rejection of claim 26 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more is withdrawn in response to Applicant’s amendment of the claim to depend upon claim 15, which was not included in this rejection.
Claim Rejections - 35 USC § 103
The rejection of claim 26 under 35 U.S.C. 103 as being unpatentable over Chen (US 20140113288) in view of Motta-Mejia et al. (Hypertension. 2017;70:372-381. DOI: 10.1161/ HYPERTENSIONAHA.117.09321), Vargas et al. (Reproductive Sciences 18(11) 1085-1091—on IDS filed 07/14/2023) and Reversade (WO2018/013053) is withdrawn in response to Applicant’s amendment. Specifically, claim 26 no longer depends from now canceled claim 12.
Maintained Rejection
Notice for all US Patent Applications filed on or after March 16, 2013: 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.
Claim Rejections - 35 USC § 103
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.
The rejection of claims 15-25 under 35 U.S.C. 103 as being unpatentable over in view of Motta-Mejia et al. (Hypertension. 2017;70:372-381. DOI: 10.1161/ HYPERTENSIONAHA.117.09321) in view of Vargas et al. (Reproductive Sciences 18(11) 1085-1091—on IDS filed 07/14/2023) and Wapner (Semin Perinatol. 2005; 29: 401-404) is maintained for reasons of record and the following. In addition, claim 26, which has been amended to depend from claim 15, is hereby included in this rejection, necessitated by Applicant’s amendment. Claim 26 recites the subject is human and Motta-Mejia et al. teach their experiment was performed in humans (see p. 373, left column, last paragraph under “Human Subjects”).
Response to Arguments
Applicant argues at p. 5 of the Remarks filed 10/23/2025 the combined teachings of the prior art do not teach or suggest methods of isolating syncytiotrophoblasts from blood or plasma samples. Applicant asserts that upon reading Motta-Mejia and colleagues, “the skilled artisan would recognize a dilution effect in blood samples and therefore would not be motived from placental perfusion methods…given their advantage in repeatability and yield of microvesicle isolation.”
This argument has been fully considered, but is not found persuasive. The claims recite extracting a blood sample of a pregnant subject, but do not specify from where the sample is collected. Motta-Mejia et al. explicitly teach collecting blood samples from both peripheral (PB) and uterine vein blood (UV—see p. 373, left column, 2nd paragraph; p. 376, Figure 2). While Motta-Mejia do indicate that the plasma prepared from the peripheral blood source did not contain as many STBMVs as that from the uterine vein blood source, both sources are reasonably construed as “blood samples” (see p. 375, left column, 2nd paragraph). Applicant is arguing limitations not present in the claims. Furthermore, it is not clear that the method of extracting STBMVs from peripheral blood, disclosed as it is by Motta-Mejia et al., is not obvious simply because it has been described as somewhat inferior to extracting STBMVs from uterine vein blood. Disclosed examples do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In addition, Motta-Mejia et al. state (p. 376, right column, last paragraph):
In addition, flow cytometry evaluation of in vivo–derived circulating STBMV from matched PB [peripheral blood] and UV [uterine vein] plasma revealed that STBMV-eNOS are released by syncytiotrophoblast and circulate in the maternal blood.
Thus, Motta-Mejia et al. clearly taught that STBMVs can circulate in maternal blood.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675