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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 24, 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 5-8, and 20-26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended independent claim 1 to recite measuring the presence, absence, or level of alpha and beta glycations of hemoglobin, and utilizing the measurements to determine susceptibility of a female to diabetes or pre-diabetes. Applicant has argued that the combination of Villarreal in view of Tariyal et al., cited in the previous Office Action do not meet the limitations of amended claim 1. After reviewing the cited prior art, the Examiner has found Applicant’s arguments to be persuasive, thus the claims are no longer rejected under 35 U.S.C. 103 as being unpatentable over the combination of Villarreal (WO 2016/094409) in view of Tariyal et al. However, after performing an updated search, independent claim 1 now stands rejected under 35 U.S.C. 102(a)(1) as being anticipated by Villarreal (WO 2019/074954). Because reference to Villarreal is newly cited, the Examiner will not argue the merits of its teachings here but will instead rely on the rejection detailed below. Therefore, in light of the teachings of the prior art, the Examiner contends that the limitations of the instant claims are taught by the references cited below, thus the claims are not in condition for allowance.
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 1, 5-8, 20-23, and 26 rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) an abstract idea. Independent claim 1 is directed to a method for evaluating one or more biomarkers in a female subject comprising obtaining a sample of the subject’s menstrual fluid, performing mass spectrometry to identify masses of proteins in the sample and measuring the presence, absence or level of alpha and beta glycations of hemoglobin, and repeating the obtaining and mass spectrometry steps on one or more subsequent samples wherein the presence, absence, or level of alpha and beta glycations of hemoglobin corresponds to susceptibility of the subject to diabetes or pre-diabetes. The steps of obtaining a sample and performing mass spectrometry to identify intact masses of proteins are mere data gathering as they require determining a level of a biomarker in a blood sample (MPEP 2106.05(g). The step of alpha and beta glycations of hemoglobin corresponding to susceptibility to diabetes or pre-diabetes is a mental process that only requires reviewing the biomarker data and making a determination of whether the subject has diabetes of pre-diabetes. Given this view, the claims is directed to an abstract idea. This judicial exception is not integrated into a practical application because nothing occurs after the subject’s diabetes status is determined. As such, the judicial exception is not integrated into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps of measuring a presence, absence, or level of alpha and beta glycations of hemoglobin are well known in the art. The Examiner makes note of reference to Villarreal (WO 2019/074954) which teaches a method for patient stratification in which alpha and beta glycations in a subjects menstrual fluid are measured (page 9 lines 31-34). As such, the additional limitations in the claim are considered as well-known, routine and conventional, and therefore does not render the claims patent eligible. Therefore, in light of the rationale provided above, the Examiner contends that the limitations of the instant claims do not comply with 35 U.S.C. 101, thus the claims are directed to ineligible subject matter.
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(s) 1, 5-8, 20-23, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Villarreal (WO 2019/074954).
For claim 1, Villarreal teaches a method for patient stratification in bodily fluids comprising obtaining a sample of a female subject’s menstrual fluid (page 3 lines 21-22), performing mass spectrometry to identify biomarkers and major proteins including hemoglobin (page 18 lines 1-3) and measuring the presence of alpha and beta glycations of hemoglobin (page 9 lines 31-34), repeating the obtaining and mass spectrometry steps with subsequent samples (page 3 lines 21-22), and determining whether the samples are indicative of the presence of diabetes or pre-diabetes (page 5 lines 10-13, page 18 lines 8-13).
For claim 5, Villarreal teaches samples obtained from a tampon, pad, or menstrual cup (page 18 lines 28-29).
For claim 6, Villarreal teaches collecting samples once a month, once every other month, once every 3 months, once every 6 months, once every 9 months, or about once a year (page 16 lines 20-23) wherein a baseline measurement is compared to subsequent measurements over time (page 16 lines 30-34).
For claims 7 and 8, Villarreal teaches obtaining menstrual fluid with a disposable device capable of being inserted into a wireless device wherein the wireless device is a home instrument (page 18 lines 14-17).
For claim 20, Villarreal teaches generating a large data set (database, page 16 lines 17-18).
For claims 21 and 22, Villarreal teaches long and short term trends in biomarkers levels and comparing the biomarker levels to a single point in time (page 16 lines 30-34).
For claim 23, Villarreal teaches evaluating disease or health related biomarkers to direct lifestyle changes and treatments (page 17 lines 16-19).
For claim 26, Villarreal teaches 3 to 4 alpha glycations corresponding to susceptibility to diabetes (page 18 lines 8-13).
Allowable Subject Matter
Claims 24 and 25 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not teach or suggest a method of evaluating one or more biomarkers wherein more than three alpha glycations and no beta glycations, or more than two alpha glycations and one or more beta glycations correspond to susceptibility of a female subject to prediabetes. Reference to Villarreal teaches that 1 to 4, 1 to 3, or 2 to 4 glycations of the alpha subunit of hemoglobin may be an indicator for diagnosis of prediabetes and/or diabetes. Villarreal does not teach identifying zero beta subunit glycations, or one or more beta subunit glycations along with alpha subunit glycations corresponds to susceptibility to prediabetes, thus the limitations of claims 24 and 25 are not taught or suggested by the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
