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 .
Election/Restrictions
Claims 1, 3-6, 9, 11, 14, 17, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/01/2026.
Applicant's election with traverse of Group I and Species IB (Claims 22-24, 26, 28-30, 32-36, 38, 40, 43-44, and 49-51) in the reply filed on 07/01/2026 is acknowledged. The traversal is on the ground(s) that the Examiner has not shown that there is a serious search and/or examination burden. This is not found persuasive because establishing that the inventions are classified in different classes and/or subclasses establishes that a serious burden exists on the Examiner if restriction is not required. Further, it is noted that the search required for Species IB (CyTOF-MS method) is not required for Species IA (biomarker level detection method). Therefore, there would be a serious burden on the examiner if restriction was not required.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 22-24, 26, 28-30, 32-36, 38, 40, 43-44, and 49-51are 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.
Claim 22 recites the limitation "the cervix" in line 3. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending line 2 of the claim to recite “conditions in a subject having a cervix, the method comprising:” is one way to resolve the indefiniteness issues.
Claims 23-24, 26, 28-30, 32-36, 38, 40, and 43-44 depend on Claim 22.
Claim 49 recites the limitation "the cervix" in line 3. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending line 2 of the claim to recite “condition in a subject having a cervix, the method comprising:” is one way to resolve the indefiniteness issues.
Claims 50-51depend on claim 49.
Appropriate corrections are required.
Claim Rejections - 35 USC § 102
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 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(s) 22-24, 26, 28-30, 32-36, 38, 40, 43-44, and 49-51 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Armant et al. (US 2017/0248599 A1).
Regarding claim 22, Armant discloses a method of identifying one or more pregnancy-associated risks or conditions in a subject, the method comprising:
a) obtaining a biological sample from the cervix of the subject, wherein the biological sample comprises extravillous trophoblast (EVT) cells ([0054], see: obtaining a maternal endocervical sample containing fetal extravillous trophoblast cells from a pregnant subject);
b) performing single-cell time-of-flight mass spectrometry (CyTOF-MS) on the biological sample to generate an output ([0156], see: CytoTof is optionally used for deep phenotyping of fetal extravillous trophoblast cell proteins); and
c) determining an elevated level or a decreased level of at least one biomarker in the biological sample relative to a standard control based on the output ([0165], see: assays of one or more biomarkers expressed by fetal extravillous trophoblast cells to detect changes indicative of abnormal placental function such as preeclampsia, intrauterine growth restriction, spontaneous abortion and preterm birth).
Regarding claim 23, Armant further discloses the method does not comprise isolating the EVT cells ([0156], see: In this method the fetal extravillous trophoblast cells are not required to be purified).
Regarding claim 24, Armant further discloses performing flow cytometry on the biological sample ([0156], see: CytoTof).
Regarding claim 26, Armant further discloses the biological sample further comprises biological material derived from the cervix of the subject ([0054], see: obtaining a maternal endocervical sample containing fetal extravillous throphoblast cells from a pregnant subject).
Regarding limitations recited in claims 28-30 which are directed to specific properties of the biological sample recited in said claim, it is noted that the analogous prior art maternal endocervical sample is disclosed to comprise the same biological material sourced from the organs of the same pregnant subject, and therefore is the same as the biological sample of claims 28-30, and therefore will inherently display the recited properties. See MPEP 2112.
Regarding claim 32, Armant further discloses washing the biological sample to achieve a single-cell solution ([0173], see: cells are then washed 2 more times).
Regarding claim 33, Armant further discloses filtering the biological sample to achieve a single-cell solution ([0173], see: cells centrifuged through a 250 micron filter).
Regarding claim 34, Armant further discloses the at least one biomarker is derived from a placenta-specific cell, a maternal cell, or a fetal cell ([0178], see: isolated maternal cells and isolated fetal extravillous trophoblast cells are used for DNA isolation).
Regarding claim 35, Armant further discloses the placenta-specific cell is an EVT, villous trophoblast or syncytiotrophoblast ([0178], see: isolated maternal cells and isolated fetal extravillous trophoblast cells are used for DNA isolation).
Regarding claim 36, Armant further discloses the at least one biomarker comprises an EVT biomarker ([0208], see: plurality of biomarkers screened in fetal extravillious trophoblast cells).
Regarding claim 38, Armant further discloses the at least one biomarker comprises a placental protein ([0208], see: plurality of biomarkers screened in fetal extravillious trophoblast cells, including placental growth factor (PGF)).
Regarding claim 40, Armant further discloses identifying a cervical condition, wherein identifying a cervical condition comprises determining an elevated level or a decreased level of at least one cervical health biomarker relative to a standard control (TABLE 1, see: cut-off).
Regarding claim 43, Armant further discloses the cervical condition is cervical infection, bleeding, inflammation, or cervical cancer ([0210], see: biomarkers for spontaneous abortion and preterm birth).
Regarding claim 44, Armant further discloses the one or more pregnancy-associated risks or conditions comprises placental dysfunction or insufficiency, pregnancy-induced hypertension, placental abruption, pregnancy loss, miscarriage, preeclampsia, eclampsia, Hemolysis Elevated Liver enzymes and Low Platelet (HELLP) syndrome, fetal growth restriction, intrauterine growth restriction, preterm birth, low birthweight, placenta percreta, placenta increta, placenta previa, gestational hypertension, gestational thrombosis, stillbirth, placental infarction, or a combination thereof ([0208], see: biomarkers for preeclampsia (PE) and intrauterine growth restriction (IUGR)).
Regarding claim 49, Armant discloses a method of identifying a pregnancy-associated risk or condition in a subject, the method comprising:
a) obtaining a biological sample from the cervix of the subject, wherein the biological sample comprises extravillous trophoblast (EVT) cells and biological material derived from the cervix of the subject, the biological material comprising at least 90% weight by volume (w/v) of the biological sample ([0054], see: obtaining a maternal endocervical sample containing fetal extravillous throphoblast cells from a pregnant subject; regarding the recitation of the weight by volume of the biological sample, since the prior art method does not disclose a sampling technique involving a sampling medium, it is the position of the Examiner, that the disclosed maternal endocervical sample would be approximately 100% weight volume of analogous biological material collected from the pregnant subject);
b) performing single-cell time-of-flight mass spectrometry (CyTOF-MS) on the biological sample to generate an output ([0156], see: CytoTof is optionally used for deep phenotyping of fetal extravillous trophoblast cell proteins); and
c) determining an elevated level or a decreased level of at least one biomarker in the biological sample relative to a standard control based on the output, thereby identifying the one or more pregnancy-associated risks or conditions ([0165], see: assays of one or more biomarkers expressed by fetal extravillous trophoblast cells to detect changes indicative of abnormal placental function such as preeclampsia, intrauterine growth restriction, spontaneous abortion and preterm birth).
Regarding claim 50, Armant further discloses the method does not include isolating the EVT cells ([0156], see: In this method the fetal extravillous trophoblast cells are not required to be purified).
Regarding claim 51, Armant further discloses performing flow cytometry on the biological sample ([0156], see: CytoTof).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
van der Zwan et al. (Visualizing dynamic changes at the maternal-fetal interface throughout human pregnancy by mass cytometry) teaches an analogous method of monitoring the maternal-fetal interface with mass cytometry of samples comprising extravillous trophoblasts (EVT).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J EOM whose telephone number is (571)270-7075. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 5712721254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT J EOM/ Primary Examiner, Art Unit 1797
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