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 05/11/2026 is acknowledged. Claims 1, 2, 4-7, 12, 14-16, 21-23, 25-27, 33, 35, 40, 42 and 44 are amended. Claims 41 and 45 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 2, 4-7, 12, 14-16, 21-23, 25-27, 33-35, 40 and 42-44 are under examination insomuch as they read upon the elected species (see p. 2 of the Office action mailed 02/09/2026).
Effective Filing Date
The effective filing date of claims of the instant application is deemed to be 06/10/2020.
Objections/Rejections Withdrawn
Claim Objections
The objection to claims 7, 15 and 33 for minor informalities is withdrawn in response to Applicant’s amendment of the claims correcting the typographical and grammatical errors.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 2, 12, 21, 23, 25 33, 44 and 44 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in response to Applicant’s amendment of the claims.
Specifically, the issue regarding insufficient antecedent basis in claim 2 is overcome in response to the amendment to claim 1 reciting a step isolating amnion and/or chorion cells in the blood sample. In addition, the phrase “such as” was deleted in claims 12, 21, 33, 40 and 44. Further, claim 21 is amended to recite an active administering step and claims 22, 23 and 42 are amended to clarify the claim steps. Claim 25 was amended to depend from claim 22 (rather than canceled claim 24).
Claim Rejections - 35 USC § 102
The rejection of claims 1, 6, 7, 14, 21, 22, 26, 27 and 40 under 35 U.S.C. 102(a)(1) as being anticipated by Boniface et al. (WO2018/027171—on IDS filed 12/09/2022) is withdrawn in response to Applicant’s amendment. Specifically, Applicant has amended claim 1 to require measuring three or more of the recited biomarkers. In addition, claim 22 has been amended to require a step isolating the amnion and /or chorion cells.
The rejection of claim 7 under 35 U.S.C. 102(a)(1) as being anticipated by Eckelt et al. (WO2012/062325—on IDS filed 12/09/2022) is withdrawn in response to Applicant’s amendment. Claim 7 now requires measuring three biomarkers selected from the recited four groups. Eckelt et al. does not teach three biomarkers from any of the four listed groups.
Rejections Maintained/New Rejection
Claim Rejections - 35 USC § 112(b)
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.
The rejection of claims 4 and 14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is maintained for reasons of record and the following.
In addition, claims 1, 2, 4-7, 12, and 14-16 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. This rejection was necessitated by amendment.
Claim 4 remains indefinite because it depends from claim 3, which was canceled. Since claim 4 depends from a canceled claim, the metes and bounds of that claim cannot be determined. The claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant (see MPEP 2171). Claims 5 and 6 are hereby included since claim 5 depends from claim 4 and claim 6 depends from claim 4 in the alternative.
Claim 14 remains indefinite because the amendment to recite “wherein a clinical condition associated with pre-term birth…” in lines 2-3 is not clarifying because claim 1, from which claim 14 depends, does not recite anything regarding pre-term birth or a clinical condition. The assay of claim 1 does not connect the steps recited therein to a clinical condition or preterm birth.
Independent claim 1 has been amended by adding the step “isolating amnion and/or chorion cells in the blood sample…” followed by the step of determining three or more biomarkers from the list “in the isolated amnion and/or chorion cells in the blood sample…” In the context of this claim, it is not clear whether the added isolation step requires actually isolating fetal cells from the blood as set forth in Example 4 (Figure 1, paragraph [0132]) or merely determining the amnion/chorion cells by measuring the recited DNA or protein biomarkers in the blood sample as set forth in paragraph [0063]. This is especially confusing since the determining step appears to take place in the blood sample, thus the claim is vague with respect to how this method/assay is carried out.
Claims 2, 4-7, 12, and 14-16 are hereby included in this rejection for depending upon an indefinite claim without resolving the indefiniteness.
Response to Arguments
Applicant’s arguments regarding the rejections under 35 USC 112(b) do not address the failure to properly amend claims 4 and 14.
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.
The rejection of claims 2, 4-6, 14-16, 22, 23, 25-27, 33-35, 40 and 42-44 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more is maintained for reasons of record and the following.
Response to Arguments
Applicant argues at p. 10 of the Remarks filed 05/11/2026 that the invention as claimed “uses a novel, structurally distinct, non-naturally occurring cellular fraction of fetal cells, a method which is not ordinary or routine, citing Illumina, Inc. V Ariosa Diagnostics, Inc, asserting that the detection of the presence of cell surface markers in amnion and/or chorion cells in the blood sample was not conventional in the prior art.
This argument has been fully considered, but is not found persuasive. The fact pattern in Illumina is different because in that case, the majority clarified it was neither a diagnostic case nor a treatment case, but a method of preparation case. In the instant case, the claims at issue recite steps encompassing diagnosis. The instant claims recite the following judicial exceptions:
Claims
Judicial Exception
4-5
Amnion/chorion cell marker(s) are differentially expressed in amnion/ chorion cells compared to a blood sample/fraction thereof, wherein a comparative log2 fold difference is at least 5, at least 10, or at least 15.
6
The presence of amnion/chorion cell marker(s) indicates of pre-term birth or an associated clinical condition.
15-16
Comparing the amount of amnion/chorion cells to a control; wherein a higher amount in the blood sample/fraction thereof compared to control indicates preterm premature rupture of the membranes and pre-term birth or an associated clinical condition.
*22-23, 25
Determining preterm premature rupture of the membranes/pre-term birth or an associated clinical condition wherein the presence of amnion/chorion cells indicates pre-term birth or an associated clinical condition, wherein the presence of amnion/chorion cells is determined by detecting one or more specific amnion/chorion cell markers; or differentially expressed [markers?] in amnion and/or chorion cells compared to a blood sample/fraction thereof isolated from the pregnant woman, wherein the log2 fold difference between the expression of the amnion and/or chorion cell marker in amnion and/or chorion cells compared with the expression in a blood sample or fraction thereof is at least 5, at least 10, or at least 15.
26-27, 33
The presence of an amnion/chorion cell marker indicates pre-term birth or an associated clinical condition, wherein said markers are listed in claim 27, and measuring further epithelial/mesenchymal markers recited in claim 33.
34-35, 40
Comparing the amount of amnion/chorion cells to a pregnant control, wherein a higher amount of amnion/chorion cells in the blood sample or fraction thereof compared to control indicates pre-term birth or an associated clinical condition.
*42-44
Comparing a gene expression profile of the isolated amnion/chorion cells to a pregnant control, wherein the gene expression profile is indicative of pre-term birth or an associated clinical condition.
*Claims 22 and 42 are independent claims
Thus, the instant claims encompass comparing and determining the presence of disease (diagnosis). See MPEP 2106.05(d)(II), which states that the courts cite detecting DNA in a sample as a laboratory technique that is well-understood, routine, and conventional activity in the life science arts.
Applicant argues further in this passage that the claims require an affirmative physical step of isolating amnion and/or chorion cells from a maternal sample. Nevertheless, the instant specification suggests isolation of fetal cells was well-known in the prior art, citing WO2012/062325 for the methods of isolating of fetal cells (see [0141]).
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 § 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.
The rejection of claims 1 and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Eckelt et al. (WO2012/062325—on IDS filed 12/09/2022) is maintained for reasons of record and the following. Applicant’s amendment to claim 1 is acknowledged, however, the claim is vague with respect to how the isolation of the amnion and/or chorion cells are carried out. See the rejection under 35 USC 112(b), above. The claims are interpreted as carrying out the isolation by determining the presence of three or more of the recited biomarkers in the blood sample.
Eckelt et al. disclose detecting KRT5, KRT17 and KRT18 in maternal blood samples (see p. 11, Table 1; p. 13, Table 3; lines 14-18). In addition, Eckelt et al. teach contacting the maternal blood sample with either hybridization probe comprising at least 10 contiguous nucleotides complementary to either the genes encoding KRT5, KRT17 and/or KRT18 or a ligand capable of cross-reacting to the KRT5, KRT17 and/or KRT18 proteins as well as epithelial markers CK1-CK8, CK10 and CK13-CK19 and/or human vimentin (see p. 15, whole page through p. 16, line 15; p. 23, lines 25-29).
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
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