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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/13/2026 has been entered.
Claims 1 and 10 are amended and 6 and 9 are newly canceled. In the response to the Restriction requirement filed 03/31/2025, Applicant provisionally elected the species of ANXA3, TGOLN2, F10 and HEXB. In the Office action mailed 05/07/2025, the examiner extended the search to include A2M, which resulted in art found with regard to additional species APOB, PZP, FN1, AGT, HEXB and VWF. In the amendment filed 08/07/2025, Applicant deleted reference to the biomarkers A2M APOB, PZP, FN1, TGOLN2, AGT, HEXB and VWF in the claims, thus the examiner extended the search to include Tenascin C (TNC). In the amendment filed 01/06/2026, Applicant deleted reference to the biomarker Tenascin C (TNC), thus, the search is being extended to include Fetuin B (FETUB) and Lipocalin 2 (LCN2), along with the originally elected Annexin A3 (ANXA3) and coagulation factor X (F10).
Applicant has requested the withdrawn claims 1-5 be rejoined and examined. See the rejoinder paragraph at p. 4 of the Restriction requirement mailed 01/29/2025, which states “[w]here applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder.” In the instant case, Applicant elected the process and not the product claims. Further, the elected process claim is not allowable, thus there are no grounds for rejoinder. Since there is no allowable generic or linking claim, claims 1-5 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claim 10 is under examination.
Effective Filing Date
The effective filing date of the instant application is 12/31/2019.
Claim Interpretation
As currently written, claim 10, unlike canceled claims 6 and 9, does not recite a judicial exception.
Objections/Rejections Withdrawn
Any previous objections or rejections of claims 6 and 9 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 Rejections - 35 USC § 112(b)
The rejection of claim 10 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 is withdrawn in response to Applicant’s amendment of the claim to clearly define the phrase “biomarkers associated with diagnosis of preeclampsia”.
Claim Rejections - 35 USC § 112(a)
The rejection of claim 10 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in response to Applicant’s amendment to limit the phrase “biomarkers associated with diagnosis of preeclampsia” to those biomarkers that have been disclosed in the instant specification.
Claim Rejections - 35 USC § 102
The rejection of claim 10 under 35 U.S.C. 102(a)(1) as being anticipated by Orak et al. (The Journal of Maternal-Fetal & Neonatal Medicine (2016), 29:2, 270-273) is withdrawn in response to Applicant’s amendment deleting reference to tenascin C (TNC).
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.
New Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tarca et al. (WO 2013/188686). Tarca et al. teach determining levels of the biomarker, fetuin B (FETUB), among others, in a biological sample obtained from a female, wherein the sample is blood (see claims 1-5). Tarca et al. contemplate measuring protein levels with antibody-based approaches, for example ELISA (see paragraph [0037]). Thus, Tarca et al. teach all of the limitations of claim 10.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Than et al. (EP 3339861). Than et al. determining levels of the biomarker, fetuin B, among others, in a biological sample, wherein the biological sample obtained from a female, wherein the biological sample is blood (see claims 1-4 and 6). Than et al. contemplate measuring protein levels with antibody-based approaches, for example ELISA (see paragraph [0034]). Thus, Than et al. teach all of the limitations of claim 10.
Claim 10 is rejected under 35 U.S.C. 102(a)1) as being anticipated by Anderberg et al. (US 20160003850). Anderberg et al. disclose detecting the biomarker, coagulation factor X, among others, in a biological sample collected from a subject, wherein said biological sample is blood and the biomarkers are measured via antibody-based assays (see claim 1; paragraphs [0042]; [0046]-[0048]; [0055]; [0084]). Anderberg et al. contemplates subjects with preeclampsia (see claim 11; paragraph [0023]). In addition, Anderberg et al. teach that lipocalin 2 may also be measured (see paragraphs [0043]; [0108]). Thus, Anderberg et al. teach all of the limitations of claim 10.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stepan et al. (J. Endocrinol. Invest. 33: 629-632, 2010). Stepan et al. teach detecting serum levels of lipocalin 2 in preeclamptic patients with a commercially available antibody-based (ELISA) assay (see abstract; p. 630, left column, 2nd paragraph), thus Stepan et al. teach all of the limitations of claim 10.
Conclusion
No claim is allowed
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