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 Arguments
Applicant's amendment and arguments filed 11/3/2025 with respect to the 35 USC 101 rejection of the claims have been fully considered but they are not persuasive. The claimed administration of clinical assessments are in themselves another set of mental analyses. A physician can analyze a patient (ask questions, read a chart, read physiological measurements form a chart, etc.) and make mental assessments from that data. Therefore the clinical assessments are part of the abstract idea itself and not an additional element that would amount to integration into a practical application or amount to significantly more than the abstract idea itself.
Applicant’s arguments regarding the unconventionality in obtaining gestational progress from a urine sample is not persuasive. The previously cited art of Statens (WO 2020/061590) and Chan (WO 2019/084033) illustrate that determining gestational progress from a urine sample is not wholly unconventional or uncommon.
Applicant’s arguments that the claims include other meaningful limitations has been considered and is not persuasive. The obtaining of a urine sample is insignificant, extra-solution activity (mere data gathering). The administering of clinical assessments is broad and due to that breadth, can be considered part of the abstract idea (another set of mental assessments).
Regarding the 35 USC 102 AND 103 rejections, the rejections have bene restructured to address the currently amended claim limitations.
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, 2 and 4-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a process ( a method for determining gestational age or time-to-delivery)
Step 2A, Prong 1
Claim 1 recites the abstract idea of predicting a gestational age or a time to delivery using measured data and performing clinical assessments/medical checkups. This can be done mentally by a trained physician that can look at a panel of measured analytes at a routine check-up and broadly predict/ascertain if a patient is in early stage pregnancy or late stage pregnancy. The administering of an assessment during a medical checkup could also be construed as a method of organizing human activity (instructing a person to go to a checkup and instructing a physician to assess a patient at said checkup)
Step 2A, Prong 2
Claim 1 fails to include additional elements that amount to integration of the abstract idea into a practical application. Claim 1 recites the additional elements of obtaining measurements and using a predictive computational model. The obtaining of measurement data is insignificant, extra-solution activity (mere data gathering) and the computational predictive model is so broadly claimed as to amount to generic computer implementation of the abstract idea; neither of which amount to integration of the abstract idea into a practical application.
Step 2B
Claim 1 fails to include additional elements, alone or in combination, that amount to significantly more than the abstract idea itself. Claim 1 recites the additional elements of obtaining measurements and using a predictive computational model. The obtaining of measurement data is insignificant, extra-solution activity (mere data gathering) and the computational predictive model is so broadly claimed as to amount to generic computer implementation of the abstract idea; neither of which amount, alone or in combination, to significantly more than the abstract idea itself.
Claims 2 and 10-18 only further defines the routine computer implementation of the abstract idea (he computer model) and also could potentially amount to a mathematical concept abstract idea.
Claims 3-9, 19 and 20 only further define the data gathering.
Claim 21 is not a particular prophylaxis and instead amounts to applying the exception in a generic way, see example a) from MPEP §2106.04(d)(2), wherein the current claim aligns with the example of “administering a suitable medication to a patient”. There is no specificity to the treatment as claimed.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4-15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Chan Zuckerberg Biohub, Inc (WO/2019/084033), herein Chan, in view of Maitre et al. “Maternal Urinary Metabolic Signatures of Fetal Growth and Associated Clinical and Environmental Factors in the INMA Study”, further in view of Buhimschi et al. (2015/0293115).
Regarding Claims 1 and 4-8, Chan discloses obtaining measurements of one or more analytes from a urine sample (par. [0014]) from an individual and predicting, using a predictive model (par. [0017]) and the analytes, a gestational age (par. [0009]). Chan discloses monitoring maternal urinary samples for gestational age but fails to disclose monitoring for the specific metabolites of the claim and fails to disclose performing clinical assessments during a periodical medical checkup.
However, Maitre discloses that metabolites in the urine such as progesterone are affected by time of gestation, wherein progesterone is excreted in urine as 5 β-pregnane-3α (p. 8, col. 2). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method in the Chan reference to include testing/monitoring for progesterone and particularly 5 β-pregnane-3α, as taught and suggested by Maitre, for the purpose of assessing fetal health and gestational development since there is a known correlation of these metabolites and gestational age/progression.
Additionally, urine samples/analysis at prenatal visits was known and common at the time the invention as effectively filed, as evidenced and taught by Buhimschi (par. [0095]) in order to provide consistent health monitoring of the patient and fetus during pregnancy and to predictably provide reliable controls with accurate data (such as date and time) for a reference comparison. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Chan and Maitre combination to include obtaining the reference samples at a prenatal visit (a clinical assessment at a medical checkup), as taught and suggested by Buhimschi, for the purpose of predictably providing reliable controls with accurate data.
In regards to Claim 2, Chan discloses the analysis can incorporate a random forest model (par.[0131]).
With regards to Claim 9, Chan discloses incorporating suspected predictors in the model and therefore discloses selecting features/ the number of features based on a contribution to the predictive power of the model (par. [0102, 0105]).
Regarding Claim 10, Chan discloses training the model on sample data from a cohort of pregnant individuals (par. [0130-0132]).
Regarding Claims 11 and 14, Chan discloses obtaining samples for the statistical analysis from a cohort of women over different time points of an entire pregnancy and comparing them to a current sample (par. [0125, 0170]) but Chan is silent regarding taking the samples during a routine prenatal visit. However, urine samples/analysis at prenatal visits was known and common at the time the invention as effectively filed, as evidenced and taught by Buhimschi (par. [0095]) in order to provide consistent health monitoring of the patient and fetus during pregnancy and to predictably provide reliable controls with accurate data (such as date and time) for a reference comparison. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Chan reference to include obtaining the reference samples at a prenatal visit, as taught and suggested by Buhimschi, for the purpose of predictably providing reliable controls with accurate data.
In regards to Claims 12 and 13, Chan discloses obtaining reference samples weekly form a cohort of 31 women during an entire pregnancy (par. [0170, 0180]).
With regard to Claim 15, Chan discloses obtaining samples at multiple different timepoints during pregnancy (par. [0085, 0091]).
In regard to Claim 17, Chan discloses obtaining samples during the course of pregnancy thus indicating the individual is known to be pregnant (par. [0091-0092]).
Regarding Claim 18, Chan discloses obtaining maternal samples to estimate gestational age but fails to explicitly disclose that the maternal sample is from an individual not diagnosed as pregnant. Chan provides ample disclosure of the presence and concentrations of placental genes, proteins, etc. in a maternal sample (par. [0049, 0079-0081]) and how these values change over the term of a pregnancy as part of a high resolution molecular clock (par. [0088]). The Examiner notes the expressions of these genes, proteins etc. are not dependent on labelling a person as pregnant or not pregnant and that performing this analysis on a person that is suspected of being pregnant (and is actually pregnant) but not positively diagnosed as being pregnant would have the same result as the person actually being positively diagnosed as pregnant. One scenario would be a person coming in for a visit after an act-home pregnancy test showed a positive or inconclusive result or coming into a vists on their own suspicion of being pregnant (no prior urine test needed). Performing a known test on an individual that can estimate a gestational age of a fetus on someone who is suspected of being pregnant is an obvious application of such a test, regardless of whether the prior art positively recites this particular application. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Chan reference to include applying the test to an individual suspected of but not diagnosed as being pregnant, as taught and suggested by Chan, for the purpose of identifying if the individual is pregnant and when they are due.
In regard to Claim 19, Chan discloses using mass spectrometry to obtain analyte measurements (claim 57).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Chan Zuckerberg Biohub, Inc (WO/2019/084033), herein Chan, in view of Maitre et al. “Maternal Urinary Metabolic Signatures of Fetal Growth and Associated Clinical and Environmental Factors in the INMA Study”, further in view of Buhimschi et al. (2015/0293115), herein Buhimischi ‘115, and Buhimschi et al. (2006/0183175), herein Buhimischi ‘175. Chan, Maître and Buhimischi ‘115 disclose obtaining urine samples but does not disclose if the patient was fasting or not. However, Buhimschi ‘175 discloses the equivalence of fasting and non-fasting urine samples (par. [0010]) for analysis of pregnancy related conditions. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize fasting urine samples given that there are a finite number of identified, predictable solutions (fasting or non-fasting), each having a reasonable expectation of success.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Chan Zuckerberg Biohub, Inc (WO/2019/084033), herein Chan, in view of Maitre et al. “Maternal Urinary Metabolic Signatures of Fetal Growth and Associated Clinical and Environmental Factors in the INMA Study”, further in view of Buhimschi et al. (2015/0293115) and Katz et al. (2015/0064695). Chan, Maitre and Buhimischi disclose all of the claimed invention except for performing sonography. However, Katz discloses performing sonography(which is a clinical assessment that is done at a medical checkup) on pregnant individuals for the purpose of identifying higher risks of genetic conditions in a fetus (par. [0084]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Chan reference to include performing sonography, as taught and suggested by Katz, for the purpose of identifying higher risks of genetic conditions in a fetus.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Chan Zuckerberg Biohub, Inc (WO/2019/084033), herein Chan, in view of Maitre et al. “Maternal Urinary Metabolic Signatures of Fetal Growth and Associated Clinical and Environmental Factors in the INMA Study”, further in view of Buhimschi et al. (2015/0293115) and O’Brien et al. (2021/0161388). Chan, Maitra and Buhimishci disclose all of the claimed invention except for monitoring for preterm labor and administering a tocolytic medication if preterm labor is identified. However, O’Brien discloses monitoring for preterm labor and treating preterm labor with tocolytic medication is a routine part of maternal healthcare during pregnancy and provides the predictable result of reducing instances of preterm birth (par. [0007]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Chan, Maitre and Buhimishci combination to include monitoring for preterm labor and treating preterm labor with tocolytic medications, as taught and suggested by O’Brien, for the purpose of reducing instances of preterm birth.
Conclusion
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.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796