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 .
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 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.
Restriction election
Applicant’s election without traverse of Group III (claims 125-135) in the reply filed on 03/06/2026 is acknowledged.
Claim Status
Claims 125-135 and 140-149 are pending.
Claims 1-124 and 136-139 are canceled.
Claims 125-135 and 140-149 are under examination.
Claims 141 and 144-146 are objected to.
Claims 125-135 and 140-149 are rejected.
Priority
This application 17772832 filed on 04/28/2022 is a 371 national phase of, PCT/US2020/058382, filed 10/30/2020, which claims domestic benefit to US provisional application 63/061,709 08/05/2020 and domestic benefit to US provisional application 62/930,465 11/04/2019 and claims domestic benefit to US provisional application 62/929,579 11/01/2019. The priority date of claim 125 and its dependent claims is determined to be 10/30/2020, the filing date of PCT/US2020/058406 because none of each of the three provisional applications 62/929,579; 62/930,465; and 63/061,709 fully supports the steps (a)-(d) recited in amended claim 125 filed on 03/06/2026.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 07/15/2022, 12/13/2023, 11/13/2024, 07/09/2025, and 03/06/2026 are in compliance with the provisions of 37 CFR 1.97 and have therefore been considered. Signed copies of the IDS documents are included with this Office Action.
Drawings
The Drawings submitted 04/28/2022 are accepted.
Claim Rejections - 35 USC § 112
35 U.S.C. 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.
Claims 126, 128, and 143 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 126, 128, and 143 incorporate a reference of a Table in the specification within the claim. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
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.
Claims 125-135 and 140-149 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 organizes judicial exception analysis into Steps 1, 2A (Prongs One and Two) and 2B as follows below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Framework with which to Evaluate Subject Matter Eligibility:
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter;
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1
With respect to Step 1: yes, the claims are directed to method i.e., a process, machine, or manufacture within the above 101 categories [Step 1: YES; See MPEP § 2106.03].
Step 2A, Prong One
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas) are as follows:
Independent claim 125:
comparing the sample component to a reference level of the one or sample components;
classifying the subject into a risk group based on one or more digital biomarkers;
determining an assessment of menstrual health using the comparison obtained in step (d) and the risk group obtained in step (e).
Dependent claim 129:
wherein step (d) comprises applying a classifier algorithm to the sample component to calculate a metric that quantifies a difference between the level of the sample component to a reference level.
Dependent claim 141:
determining a gene expression profile from the sample.
Dependent claims 126, 128, 131-132, 140, and 142-148 recite further steps that limit the judicial exceptions in independent claim 125 and, as such, also are directed to those abstract ideas. For example, claim 126 further limits the biomarkers of claim 125, claim 131 further limits the menstrual health of claim 125, claim 132 further limits the menstrual cycle disorder of claim 125, claim 140 further limits reference level of claim 125, claims 128 and 142 further limit the sample component of claim 125, claim 143 further limits the gene of claim1 25, claim 144 further limits cells of claim 125, claims 145-146 further limit the component of claim 125, claim 147 further limits the biomarkers of claim 125, and claim 148 further limits data of claim 125;
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind and/or by mathematical operation because the method only requires a user to manually compare, classify and determine. Without further detail as to the methodology involved in “comparing the sample component to a reference level”, “classifying the subject into a risk group”, “determining a gene expression profile”, and “determining an assessment of menstrual health” under the BRI, one may simply, for example, use pen and paper to characterize fluids. Some of these steps and those recited in the dependent claims require mathematical techniques such as “applying a classifier algorithm to the sample component to calculate a metric that quantifies a difference between the level of the sample component to a reference level”.
Therefore, claim 125 and those claims dependent therefrom recite an abstract idea [Step 2A, Prong 1: YES; See MPEP § 2106.04].
Step 2A, Prong Two
Because the claims do recite judicial exceptions, direction under Step 2A, Prong Two, provides that the claims must be examined further to determine whether they integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the judicial exceptions are integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exceptions, the claim is said to fail to integrate the judicial exceptions into a practical application (MPEP 2106.04(d).III).
Additional elements, Step 2A, Prong Two
With respect to the instant recitations, the claims recite the following additional elements:
Independent claim 125:
receiving a fluid sample collected from the vaginal cavity of a subject, the fluid sample comprising one or more components;
contacting the fluid sample with a buffer solution under conditions to preserve one or more components of the fluid sample;
determining the presence or level of a sample component from the one or more components of the fluid sample;
Dependent claims 127, 130, 133, 135, 142, and 149 recite steps that further limit the recited additional elements in the claims. For example, claims 127, 130, 133, 135, and 149, further limit the fluid sample of claims 125;
Considerations under Step 2A, Prong Two
With respect to Step 2A, Prong Two, the additional elements of the claims do not integrate the judicial exceptions into a practical application for the following reasons. Those steps directed to data gathering, such as “receiving”, “contacting”, and determining” perform functions of collecting the data needed to carry out the judicial exceptions. Data gathering and outputting do not impose any meaningful limitation on the judicial exceptions, or on how the judicial exceptions are performed. Data gathering and outputting steps are not sufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)).
Thus, none of the claims recite additional elements which would integrate a judicial exception into a practical application, and the claims are directed to one or more judicial exceptions [Step 2A, Prong 2: NO; See MPEP § 2106.04(d)].
Step 2B (MPEP 2106.05.A i-vi)
According to analysis so far, the additional elements described above do not provide significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional. Conventionality is a question of fact and may be evidenced as: a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, Further, the courts have found that receiving data are well-understood, routine, and conventional functions of a computer when claimed in a merely generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, as discussed in MPEP 2106.05(d)(II)(i)).
As such, the claims simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (MPEP2106.05(d)). The data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself [Step 2B: NO; See MPEP § 2106.05].
Therefore, the instant claims are not drawn to eligible subject matter as they are directed to one or more judicial exceptions without significantly more. For additional guidance, applicant is directed generally to the MPEP § 2106.
Furthermore, the courts have recognized the following laboratory techniques as well-understood, routine, conventional activities in the life science arts when they are claimed in a merely generic manner or as insignificant extra-solution activity: i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 125-135, and 140-149 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tariyal et al. (WO 2017/180909, published 10/19/2017, cited on IDS dated 07/15/2022).
Claim 125 is directed to a method of producing a desired preparation for assessment of menstrual health, comprising:(a) receiving a fluid sample collected from the vaginal cavity of a subject, the fluid sample comprising one or more components;
Tariyal discloses devices and methods for analysis of vaginal biological samples (abstract). Tariyal further discloses specifically teaches use of a device for detecting markers (e.g. biomarkers) associated with cervicovaginal fluids [0478]. Tariyal also discloses collecting vaginal biological samples with a sample collector and eluting the biological material (i.e. biological sample) [0229].
(b) contacting the fluid sample with a buffer solution under conditions to preserve one or more components of the fluid sample;
Tariyal discloses receiving the biological sample with buffer from the sample collector [0416, step 12].
(c) determining the presence or level of a sample component from the one or more components of the fluid sample;
Tariyal discloses detecting a presence or level of biomarkers in a sample [0025].
(d) comparing the sample component to a reference level of the one or sample components;
Tariyal discloses comparing biomarkers at different times using different samples of cervicovaginal fluid (longitudinal menstrual samples) to identify differences or changes in levels of biomarkers [0025 and 0466]. Tariyal further discloses the expression level of the biomarker in the endometriosis sample from a subject diagnosed of endometriosis can be increased or decreased when compared to the expression level of the biomarker in a sample from a second subject that is not diagnosed with endometriosis [00425].
(e) classifying the subject into a risk group based on one or more digital biomarkers; and
Tariyal discloses as described herein, biomarkers can be used for determining the severity of endometriosis in a biological sample that has been determined to have endometriosis. Severity of endometriosis can be classified as mild or moderate [00429]. Tariyal further discloses the expression level of the biomarker in the endometriosis sample from a subject diagnosed of endometriosis can be increased or decreased when compared to the expression level of the biomarker in a sample from a second subject that is not diagnosed with endometriosis [00425].
(f) determining an assessment of menstrual health using the comparison obtained in step (d) and the risk group obtained in step (e).
Tariyal discloses as described herein, biomarkers can be used for determining the severity of endometriosis in a biological sample that has been determined to have endometriosis. Severity of endometriosis can be classified as mild or moderate [00429]. Tariyal further discloses the expression level of the biomarker in the endometriosis sample from a subject diagnosed of endometriosis can be increased or decreased when compared to the expression level of the biomarker in a sample from a second subject that is not diagnosed with endometriosis [00425].
Claim 126 is directed to the method of claim 125, wherein at least one of the one or more digital biomarkers comprises a factor listed in Table 4.
Tariyal discloses in some embodiments the disclosed device focuses on Example 16: Cervical Cancer detecting markers associated with uterine or endometrial 20 cancers from menstrual blood or cervicovaginal fluid.
Claim 127 is directed to the method of claim 125, wherein the one or more components of the fluid sample preserved are selected from the group consisting of intact cells from the vaginal- cervical space, protein, metabolite, DNA, RNA or any combination thereof.
Tariyal discloses that the sample collector can absorb cervicovaginal fluids (para 254) and using reagents for extracting DNA or RNA (biological material in the instant application) [00051 and claim 60].
Claim 128 is directed to the method of claim 125, wherein the one or more sample components comprise one or more markers selected from Table 1, Table 2, and/or Table 3
Tariyal discloses hsa-miR-34c-5p and hsa-miR-199b-3p from Table 3 of the instant application [tbl 13].
Claim 129 is directed to the method of claim 125, wherein step (d) comprises applying a classifier algorithm to the sample component to calculate a metric that quantifies a difference between the level of the sample component to a reference level.
Tariyal discloses methods and systems of the present disclosure can be implemented by way of one or more algorithms [00463]. Tariyal further discloses comparing biomarkers at different times using different samples of cervicovaginal fluid (longitudinal menstrual samples) to identify differences or changes in levels of biomarkers [0025 and 0466]. Tariyal also discloses the expression level of the biomarker in the endometriosis sample from a subject diagnosed of endometriosis can be increased or decreased when compared to the expression level of the biomarker in a sample from a second subject that is not diagnosed with endometriosis [00425].
Claim 130 is directed to the method of claim 125, wherein the fluid sample comprises menstrual fluid.
Tariyal discloses the devices and systems disclosed herein can be used for collecting biological samples, such as vaginal fluid, cells, and/or menstrual fluid, for analysis of vaginal microbiomes [00552].
Claim 131 is directed to the method of claim 125, wherein the assessment of menstrual health indicates that the subject has a menstrual cycle disorder.
Tariyal discloses patients with endometriosis mainly complain of pelvic pain, dysmenorrhea, and/or dyspareunia [00424]. Tariyal further discloses the associated symptoms can impact the patient's general physical, mental, and/or social well-being [00424].
Claim 132 is directed to the method of claim 125, wherein the menstrual cycle disorder is heavy menstrual bleeding (HMB).
Tariyal discloses in a randomly selected group of premenopausal women, the most common amount of menstrual flow (measured in a laboratory from all collected tampons and pads) is about two tablespoons (30 mL) in a whole period (www.cemcor.ubc.ca/resources/very-heavy-menstrual-flow) [00419]. Tariyal further discloses the menstrual flow comprises more than just blood [00419]. Tariyal also discloses often, shed cells from the lining of the uterus and endometriosis, secreted mucus, and cervicovaginal fluid (CVF) in the cervicovaginal canal are discharged along with the menstrual blood, which can be collected for diagnostic and/or screening test for diseases [00419].
Claim 133 is directed to the method of claim 125, wherein the fluid sample is obtained from the subject during the subject's menstrual window.
Tariyal discloses detecting changes in expression level of biomarkers [00272], testing biological samples collected from a particular menstrual phase [00272] and assaying at different times (i.e. a longitudinal menstrual sample).
Claim 134 is directed to the method of claim 125, further comprising repeating steps (a)- (e) for two or more longitudinal samples from the subject.
Tariyal discloses detecting changes in expression level of biomarkers [00272], testing biological samples collected from a particular menstrual phase [00272] and assaying at different times (i.e. a longitudinal menstrual sample).
Claim 135 is directed to the method of claim 125, wherein the fluid sample is received in a sample collector selected from the group consisting of a pad, a tampon, a vaginal cup, a cervical cap, a menstrual disk, a cervical disk, a sponge, and an interlabial pad.
Tariyal discloses in some embodiments, the sample collector comprises a cup, a rod, a cylinder, a pad, or a threaded matrix [0021].
Claim 140 is directed to the method of claim 125, wherein the reference level is obtained from a sample of a healthy control subject or an average level from a group of healthy control subjects.
Tariyal discloses comparing biomarkers at different times using different samples of cervicovaginal fluid (longitudinal menstrual samples) to identify differences or changes in levels of biomarkers [0025 and 0466]. Tariyal further discloses the expression level of the biomarker in the endometriosis sample from a subject diagnosed of endometriosis can be increased or decreased when compared to the expression level of the biomarker in a sample from a second subject that is not diagnosed with endometriosis [00425].
Claim 141 is directed to the method of claim 125, wherein determining the presence or level of a sample component comprises determining a gene expression profile from the sample.
Tariyal discloses detecting changes in expression level of biomarkers [00272]. Tariyal further discloses CVF may be used as samples for the analysis of proteins, thereby finding correlations between different expression profiles and specific pathologies [00442].
Claim 142 is directed to the method of claim 125, wherein the sample component for step (c) comprises RNA.
Tariyal discloses nucleic acid samples (biological material) that include RNA and DNA [00231].
Claim 143 is directed to the method of claim 140, wherein step (c) determines the presence or level of a gene selected from Table 2, Table 3 or Table 7.
Tariyal discloses hsa-miR-34c-5p and hsa-miR-199b-3p from Table 3 of the instant application [Table 13].
Claim 144 is directed to the method of claim 125, wherein determining the presence or level of a sample component comprises determining the presence or level of one or more types of cells selected from the group consisting of endothelial cells, epithelial cells, mesenchymal cells, erythrocytes, stromal cells, immune cells, and stem cells.
Tariyal discloses in some embodiments, the disclosed device can be used to detect HIV infection and monitor CD4 cell counts in menstrual blood or cervicovaginal fluids [00509].
Claim 145 is directed to the method of claim 125, wherein determining the presence or level of a sample component comprises determining the presence or level of one or more miRNA.
Tariyal discloses detection of endometriosis is achieved by detecting differential expression of microRNAs such as biomarkers set forth in Table 13 [00438].
Claim 146 is directed to the method of claim 125, wherein determining the presence or level of a sample component comprises determining the presence or level of methylation of one or more target genes.
Tariyal discloses detection of endometriosis is achieved by detecting differential expression of methylation biomarkers [00436].
Claim 147 is directed to the method of claim 125, wherein at least one of the one or more digital biomarkers is obtained from survey data of the subject.
Tariyal discloses the website can serve as a portal to collect phenotypic and demographic data on consumers [00409]. Tariyal further discloses lifestyle choices, predispositions for certain diseases, age, pre-existing conditions and other health factors determine what tests a woman should be testing for on a regular basis [00409].
Claim 148 is directed to the method of claim 147, wherein the survey data comprises one or more of a menstrual cycle phenotype, a physical body characteristic, a disease or condition, a medical treatment, demographic information, lifestyle information, ancestry, sexuality, menstrual management, health care usage and health care access.
Tariyal discloses the website can serve as a portal to collect phenotypic and demographic data on consumers [00409]. Tariyal further discloses lifestyle choices, predispositions for certain diseases, age, pre-existing conditions and other health factors determine what tests a woman should be testing for on a regular basis [00409].
Claim 149 is directed to the method of claim 125, wherein the method further comprises obtaining two or more fluid samples from the vaginal cavity of the same subject, wherein the two or more fluid samples are from different time points within the subject's menstrual cycle, wherein step (a) is repeated for each of the two or more fluid samples and wherein the level of gene expression for each of the two or more fluid samples are compared in step (c).
Tariyal discloses detecting a presence or level of biomarkers in a sample [0025] and comparing biomarkers at different times using different samples of cervicovaginal fluid (longitudinal menstrual samples) to identify differences or changes in levels of biomarkers [0025 and 0466].
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dawn M. Bickham whose telephone number is (703)756-1817. The examiner can normally be reached M-Th 7:30 - 4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached at 571-272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.M.B./Examiner, Art Unit 1685
/Soren Harward/Primary Examiner, TC 1600
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