CTNF 18/251,703 CTNF 80717 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 Restriction/Election Applicant’s election of without traverse of C19H28O8S, C25H34O10, estriol glucuronide in response to election of species requirement is acknowledged. Claims 1-20 read on the elected species. Status of the claims Claims 1-20 are examined on merits in this office. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more. STEP 1: The instantly claimed invention is directed to a method for detecting one or more analytes. Therefore, the instantly claimed invention falls into one of the four statutory categories. (Step 1, YES) ELIGIBILITY STEP 2A (Prongs 1 and 2); Is the claim directed to a law of nature, a natural phenomenon or an abstract idea. WHETHER A CALIM IS DIRECTED TO A JUDICIAL EXCEPTION. First it is determined in Prong 1 whether a claim recites a judicial exception, and if so, then it is determined in Prong 2 if the recited judicial exception is integrated into a practical application of that exception. STEP 2A Prong 1: Claim 1 recites the following steps which fall under the mental processes groupings of abstract ideas and law of nature. Claim 1 recites a method for determining gestational age of a pregnant individual, the method comprising measuring one or more analytes of a urine sample and estimating, using a predictive computational model and the one of more analyte measurements, a gestational age of the individual. The limitations are abstract ideas of mental processes for the following reasons. In this case, the step of estimating can be performed in the practitioner’s mind. Furthermore, the broadest reasonable interpretation of estimating and predicting can be practically performed in the mind assisted with pen and paper. Thus, these limitations recite a mental process. Further, claim 1 discloses correlating the measured increase of decrease of analytes with a gestational age. The correlation of the measured analytes with the gestational age can be categorized as a law of nature/natural phenomenon; this is a judicial exception as the correlation exists in nature apart from any human action. Dependent claims 2-7 merely teaches sample is urine and known predictive models for the calculation and the claims are directed to correlation of the analytes in the sample with the gestational age and thus law of nature and computational modeling are mathematical concepts and/or mental processes that can be performed in human mind with a pen and paper. Claims 8-19 disclose various analytes to be detected including three analytes, however, determining gestational age is corelated with the detection of the analytes and correlating the analytes to the gestational age, which is directed to law of nature. STEP 2A Prong 2: The analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. Besides the abstract ideas and law of nature, claim 1-19 do not recite additional steps. However, claim 20 recites additional step of treating the individual based on the estimated gestational age. The treating step is disclosed as high level of generality and the limitation in the claim is thus insignificant extra-solution activity. Do the additional elements integrate the judicial exception into a practical application? (NO) STEP 2B: Does the claim recite additional elements that are sufficient to amount to significantly more than the judicial exception? Therefore, 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) Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to abstract ideas and the laws of nature/natural phenomenon without significantly more. For all of these reasons, the claims fail to include additional elements that are sufficient to amount to significantly more than the judicial exception(s). For additional guidance, applicant is directed generally to applicant is directed generally to the MPEP § 2106. Claim Rejections - 35 USC § 112 Claim Rejections - 35 USC § 112 07-30-01 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. 07-34-01 Claim 18 is 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 18 recites “The method, wherein the individual has not been diagnosed as pregnant.”. The claim as articulated, seems to intend to be directed to a previous claim (“ The method) but however, since any claim does not recite the claim number, it is unclear what claim is intended for its dependency and thus the process on which the claim 17 depends is vague and indefinite. If the claim is indented to be dependent from claim 1, the limitation of “has not been diagnosed as pregnant” does not read on claim 1 because claim 1 is directed to determining gestational age of a pregnant individual , which clearly indicates that the individual is diagnosed as pregnant. 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 07-31-01 Claim 1-20 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites a “method for determining gestational age of a pregnant individual, the method comprising: measuring one or more analytes of a urine sample collected from an individual; and estimating, using a predictive computational model and the one or more analyte measurements, a gestational age of the individual”. As claimed, the gestational age of the individual can be determined by measuring one or more of any analytes in urine using a predictive computational model, which does not have a clear descriptive support in the specification. As claimed “one or more analyte” includes any one of a single analyte and thus the prediction can be based on measuring a single analyte, which also does not have a clear descriptive support in the specification. Moreover, the metabolites are disclosed in the claims with molecular formulas which includes various isomers with different atomic arrangements and prediction of different isomers encompassed by each of the disclosed molecular formula has not been clearly described and does not have a clear descriptive support in the specification. Throughout the specification, the disclosure of prediction of GA age with urine with high accuracy and confidence is limited to using a combination of at least three metabolites out of some specific metabolite and estriol glucuronide (para [0052]; [0126]; Fig. 14) wherein important metabolites are sulfated metabolites C19H28O8S and C19H26O7S and potential glucuronide derivatives C25H34O10 and C24H34O9 and estriol glucuronide. However, throughout the specification, prediction of GA with high accuracy and high confidence based on only a single specific metabolite has not been established. MPEP § 2163 further states that, for a claimed genus, the written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure , or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus: A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that “only describe[d] one type of structurally similar antibodies” that “are not representative of the full variety or scope of the genus.”). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). Emphasis added. Therefore, from the disclosure of only a few specific metabolites and from the disclosure of prediction of gestational age with confidence from the combined profile of at least three of the few metabolites, cannot be considered representative of determining gestational age of a pregnant individual from the measurement of a single metabolite or from the enormous number of various metabolites from urine sample. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1-7 and 17 is/are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Moufarrej et al (WO 2019084033A1; cited in the IDS of 12/29/2025) . In regards to claims 1 and 17, Moufarrej discloses a method for determining gestational age of a pregnant individual (Claim 1, method of estimating gestational age of a fetus comprising analyzing a maternal sample to determine an expression profile from a panel comprising one or more placental genes;[Para. [0164), method performed using a computer for estimating gestational age of a fetus is provided comprising: (a) obtaining one or more expression profiles from a maternal sample of a pregnant woman carrying a fetus); the method comprising: measuring one or more analytes of a urine sample collected from an individual (Claim 11, the expression profile is determined by measuring cell free RNAs (cfRNAs) in the maternal sample; Para. [0164), obtaining one or more expression profiles from a maternal sample of a pregnant woman carrying a fetus, wherein the expression profile(s) corresponds to the expression of cfRNA transcripts from a first panel of genes; Para. [0090), A maternal sample (e.g., plasma or urine) may be collected and cfRNA may be isolated from the sample immediately or after storage); and estimating, using a predictive computational model and the one or more analyte measurements, a gestational age of the individual (Claim 11, the expression profile is determined by measuring cell free RNAs (cfRNAs) in the maternal sample; Para. [0164), obtaining one or more expression profiles from a maternal sample of a pregnant woman carrying a fetus, wherein the expression profile(s) corresponds to the expression of cfRNA transcripts from a first panel of genes; Para. [0019), comparing the maternal expression profile to a reference profile, wherein the comparison of the maternal expression profile to the reference profile allows for the for estimation of gestational age ... the comparison of the maternal expression profile to the reference profile is performed by comparing the maternal expression profile to a gestational function that provides a gestational age based on an input of one or more expression levels, wherein the gestational function is determined by fitting a model to a plurality of calibration samples having measured expression levels and of which a gestational age is known. In some versions, the method uses a regression model; Para. [0020), the method is carried out by a computer). In regards to claim 2, Moufarrej discloses the method of claim 1 further comprising: collecting the urine sample from the individual (Para. [0090), A maternal sample (e.g., plasma or urine) may be collected and cfRNA may be isolated from the sample immediately or after storage). In regards to claim 3, Moufarrej discloses the method of claim 1, wherein the urine sample is collected before 20 weeks of gestation (Para. (0032), the method includes a maternal sample from blood, blood plasma, blood serum, or urine ... maternal sample obtained after the second month and prior to the eighth month of pregnancy. In some embodiments, the method includes a maternal sample obtained during the second trimester of pregnancy). In regards to claims 4-6, Moufarrej teaches that multiple urine samples may be collected, For example, maternal samples can be collected etach trimester, or monthly for a period during the course of pregnancy or my be collected more frequently (para [0091]). In regards to claim 7, Moufarrej teaches that the gestational function is determined by fitting a model to a plurality of calibration samples having measured expression levels and of which a gestational age is known. In some versions, the method uses a regression model; Para. [0129], wherein the method is carried out by a computer (para [0020]). Moufarrej also teaches random forest linear regression. Para [0176]) . Claim Rejections - 35 USC § 103 07-20-aia AIA The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 07-15 AIA Claim s 1-7 and 17-19 is/are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Moufarrej et al (WO 2019084033A1) . Maufarreij has been described above anticipating the method of determining gestational age of a pregnant individual by measuring one or more analyte of urine sample. Maufarreij teaches material sample from pregnant individual (para [0085]) but however, does not teach how the individual is diagnosed as pregnant. However, one of ordinary skilled in the art can easily envisage identifying the patient as pregnant can be verified by various means and the common method includes pregnancy test, and sonography . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Liang et al (Cell 2020) teaches prediction of gestational age and time of pregnant individual from metabolic profiling of plurality of metabolites. Liang teaches that the sample is blood samples but do not teach metabolites from urine sample . Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAFIQUL HAQ whose telephone number is (571)272-6103. The examiner can normally be reached on Mon-Fri 8-4:30. 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, Gregory S. Emch can be reached on 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. 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If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SHAFIQUL HAQ/Primary Examiner, Art Unit 1678 Application/Control Number: 18/251,703 Page 2 Art Unit: 1678 Application/Control Number: 18/251,703 Page 3 Art Unit: 1678 Application/Control Number: 18/251,703 Page 4 Art Unit: 1678 Application/Control Number: 18/251,703 Page 5 Art Unit: 1678 Application/Control Number: 18/251,703 Page 6 Art Unit: 1678 Application/Control Number: 18/251,703 Page 7 Art Unit: 1678 Application/Control Number: 18/251,703 Page 8 Art Unit: 1678 Application/Control Number: 18/251,703 Page 9 Art Unit: 1678 Application/Control Number: 18/251,703 Page 10 Art Unit: 1678 Application/Control Number: 18/251,703 Page 11 Art Unit: 1678 Application/Control Number: 18/251,703 Page 12 Art Unit: 1678
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