DETAILED ACTION
Applicant's response, filed 06/26/2025, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Herein, "the prior Office action" refers to the Final rejection of 01/27/2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/26/2025 has been entered.
Claim Status
Claims 1, 3-16, 18, 23, 25, and 26 are currently pending.
Claims 2, 17, 19-22, 24-28 were cancelled.
Claim 26 was withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the Applicant's remarks, filed 07/17/2024.
Claims 1, 3-16, 18, 23, and 25 are under exam herein.
Claims 1, 3-16, 18, 23, and 25 are rejected.
Withdrawn Rejections/Objections
Rejections and/or objections not reiterated from previous office action (Final Rejection 01/27/2025) are hereby withdrawn in view of the amendments filed 06/26/2025. On further consideration, newly recited objections/rejections/portions in view of the amendments are recited below.
The rejection of claims 3-15 is withdrawn under 35 U.S.C. 112(b) as being indefinite in view of instant application amendments changing their parent claim to independent claim 1.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 3-16, 18, 23, and 25) in the reply filed 07/17/2024 is acknowledged.
Election was made without traverse in the Applicant's remarks, filed 07/17/2024.
Claim 26 was withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
The previously discussed claim for the benefit of priority assigned an effective filing date of 09/07/2018 to all claims. In future actions, the effective filing date of one or more claims may change, due to claim amendments, or further analysis of the disclosure(s) of the priority application(s).
Information Disclosure Statement
The Information Disclosure Statement, filed 06/26/2025, has been considered. Signed copies of the IDS are included with this Office Action
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, 3-16, 18, 23, and 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture, or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
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
(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:
With respect to step (1): yes, the claims are directed to a method and system for differentiating genetic origins of fetal cellular DNA, therefore the answer is "yes".
With respect to step (2A)(1), the claims recite abstract ideas. To determine if the claims recite any concepts that equate to an abstract idea, law of nature, or natural phenomenon, MPEP at 2106.03 teaches abstract ideas include mathematical concepts (mathematical formulas or equations, mathematical relationships, and mathematical calculations), certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, evaluating, and organizing information (see MPEP 2106.04(a)(2)). In the instant application, the claims recite the following limitations that equate to an abstract idea with mental steps and mathematical concepts.
With respect to the instant claims, under the step (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular steps for analyzing fetal DNA information) and mathematical concepts (in particular mathematical relationships between genetic data).
The claims directing to abstract ideas are as follows:
Mental processes:
Claim 1: identifying, from the genotype of the pregnant female and from the genotype of fetus in the current pregnancy, a set of informative genetic markers, wherein each informative genetic marker of the set of informative genetic markers is homozygous in the pregnant female and is heterozygous in the fetus in the current pregnancy; (d) for the fetal cellular DNA obtained from the pregnant female; determining one or more alleles at each informative genetic marker of the set of informative genetic markers, wherein the fetal cellular DNA originates from the fetus in the current pregnancy or a fetus in a historical pregnancy;
Claim 3: determining whether the fetal cellular DNA originates from the fetus in (1) the current pregnancy, (2) the historical pregnancy and having a same father as the fetus in current pregnancy, or (3) the historical pregnancy and having a different father as the fetus in the current pregnancy.
Mathematical concepts:
Claims 1 and 25: providing as input to a probabilistic model the one or more alleles at each informative genetic marker of the fetal cellular DNA obtained from the pregnant female; determining, as output of the probabilistic model, probabilities of three scenarios: the fetal cellular DNA obtained from the pregnant female originates from (1) the fetus in the current pregnancy,(2) the fetus in the historical pregnancy and having a same father as the fetus in the current pregnancy, and (3) the fetus in the historical pregnancy and having a different father from the fetus in the current pregnancy; and determining, based on the probabilities of the three scenarios, whether the fetal cellular DNA originates from the fetus in the current pregnancy…
Claim 4: …input to the probabilistic model a number of shared genetic markers, wherein a shared genetic marker is a genetic marker in the informative genetic markers for which the fetal cellular DNA obtained from the pregnant female and the fetus in the current pregnancy have same alleles.
Claim 5: wherein the probabilistic model calculates the probabilities of the three scenarios given the number of shared genetic markers based on probabilities of the number of shared genetic markers given the three scenarios.
Claim 6: wherein the probabilistic model calculates the probabilities of the three scenarios given the number of shared genetic markers
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wherein p(sj k) is a probability of scenario i, or s,, given the number of shared genetic markers, or k, p (kIs ) is a probability of the number of shared genetic markers given scenario i, p(s) is an overall probability of scenario i, and p (k) is an overall probability of the number of shared genetic markers.
Claim 7: wherein, for each scenario, the probabilistic model simulates the number of shared genetic markers given scenario i, or ks, as a random variable drawn from a beta-binomial distribution.
Claim 8: wherein the probabilistic model simulates the number of shared genetic markers given scenario i, or k as a random variable drawn from a binomial distribution with a success rate yu , and ,u is a random variable drawn from a beta distribution with hyperparameters at and bj; namely, ks1BZ-E(npj) and l-Bet.(a,is), n being the number of informative genetic markers in the set of informative genetic markers.
Claim 9: wherein the probability of the number of shared genetic markers given scenario i is calculated from the following likelihood function:
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wherein n is the number of informative genetic markers, k is the number of shared genetic markers, #( ) is a beta function, and at and ba are the hyperparameters of the beta distribution for scenario i.
Claim 10: wherein
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wherein v is a parameter representing a number of pseudo counts or observations.
Claim 11: wherein ,u is set to correspond to an expected proportion of shared genetic markers among the set of informative genetic markers in scenario i.
Claim 12: wherein the probabilistic model calculates al, the expected proportion of shared genetic markers for scenario (1), as follows:
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wherein n is the number of informative genetic markers.
Claim 13: wherein the probabilistic model calculates u2, the expected proportion of shared genetic markers for scenario (2), as follows,
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wherein pj is a population frequency of a hetero-allele at the fh marker, the hetero-allele being an allele at an informative genetic marker found in the fetus in the current pregnancy but not in the pregnant female.
Claim 14: wherein the probabilistic model calculates ,,, the expected proportion of shared genetic markers for scenario (3), as follows:
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wherein pj is a population frequency of a hetero-allele at the Jth marker.
Claim 15: providing prior probabilities of the three scenarios to the probabilistic model, wherein the probabilistic model provides posterior probabilities of the three scenarios based on the prior probabilities of the three scenarios, as well as on the alleles at the one or more markers.
Hence, the claims explicitly recite elements that, individually and in combination, constitute abstract ideas.
With respect to step (2A), under the broadest reasonable interpretation (BRI), the instant claims a method and system for differentiating genetic origin of fetal cellular DNA. Instant claims are therefore directed to the judicial exceptions of abstract groupings, both mathematical (using the probabilistic model…simulates/calculates the probabilities of the three scenarios…uses mathematical equations in claims 6-14 including binomial distribution/random variables/ hyperparameters… calculates… the expected proportion…prior/posterior probabilities) and mental processes (identifying informative genetic markers…determining alleles…whether the fetal cellular DNA originates from…) which can be performed with the human mind with pen and paper.
Because the claims do recite judicial exceptions, direction under step (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas 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 abstract idea is 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 exception, the claim is said to fail to integrate into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements considered for practical application:
Claims 1: (a) receiving a genotype of the fetus in the current pregnancy, wherein the genotype of the fetus in the current pregnancy comprises one or more alleles for each genetic marker of a plurality of genetic markers, where each genetic marker represents a polymorphism at a unique genomic locus; (b) receiving a genotype of the pregnant female, wherein the genotype of the pregnant female comprises one or more alleles for each genetic marker of the plurality of the genetic markers
Claim 1: wherein at least (e) and (f) are performed by a computer comprising a processor and memory.
Claim 16: obtaining cell free DNA ("cfDNA") from the pregnant female; and genotyping the cfDNA from the pregnant female to produce (i) the genotype of the fetus in the current pregnancy, and (ii) the genotype of the pregnant female.
Claim 18: wherein the fetal cellular DNA is from a circulating fetal cell ("cFC") circulating in the pregnant female.
Claim 23: wherein each informative genetic marker is biallelic.
Claim 25: computer system… processors; system memory; and one or more computer-readable storage media having stored thereon computer-executable instructions that, when executed by the one or more processors, cause the computer system to implement…
Said steps that are “in addition” to the recited judicial exception in the instant claims represent those of mere instructions or field of use limitations (obtaining cell free DNA ("cfDNA") from the pregnant female; and genotyping the cfDNA) to implement in the recited judicial exception and do not impart meaning to said recited judicial exception, such that is applied in a practical manner. Further with respect to the additional elements in the instant claims, these steps are directed to mere data gathering and handling (receiving a genotype of the fetus pregnant female…) to carry out the abstract idea without imposing any meaningful limitation on the abstract idea. Thereby these steps are insignificant extra-solutions activity steps and are insufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Further steps herein directed to additional non-abstract elements of computer components (claim 25: computer system… processors; system memory; and one or more computer-readable storage media …) do not describe any specific computational steps by which the “computer parts” perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than generic computer elements used as a tool to perform the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc.… are recited so generically (FIG.10; [0044-0045]) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer. (see MPEP 2106.05(f)). None of the recited dependent claims recite additional elements which would integrate a judicial exception into a practical application.
As such, the claims are lastly evaluated using the step (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate the judicial exceptions into a practical application, the claims also lack a specific inventive concept. The judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering, instructions, and field of use limitations described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either 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 recitations, the claims recite the following additional elements considered for inventive concepts:
Claims 1: (a) receiving a genotype of the fetus in the current pregnancy, wherein the genotype of the fetus in the current pregnancy comprises one or more alleles for each genetic marker of a plurality of genetic markers, where each genetic marker represents a polymorphism at a unique genomic locus; (b) receiving a genotype of the pregnant female, wherein the genotype of the pregnant female comprises one or more alleles for each genetic marker of the plurality of the genetic markers
Claim 1: wherein at least (e) and (f) are performed by a computer comprising a processor and memory.
Claim 16: obtaining cell free DNA ("cfDNA") from the pregnant female; and genotyping the cfDNA from the pregnant female to produce (i) the genotype of the fetus in the current pregnancy, and (ii) the genotype of the pregnant female.
Claim 18: wherein the fetal cellular DNA is from a circulating fetal cell ("cFC") circulating in the pregnant female.
Claim 23: wherein each informative genetic marker is biallelic.
Claim 25: computer system… processors; system memory; and one or more computer-readable storage media having stored thereon computer-executable instructions that, when executed by the one or more processors, cause the computer system to implement…
These additional elements do not contribute significantly more to well-known and conventional steps to obtain genetic data, performed with routine laboratory equipment, and analyzed by one with ordinary skill in the art as of the effective filing date. The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity: analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546; 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); using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015); detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017); amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014). There is no active step of DNA sequencing or genotyping, which are unconventional. Data (genotypes, shared/informative genetic markers) are merely manipulated data to be used in the judicial exception. The additional elements do not comprise an inventive concept when considered individually or as an ordered combination, as evidenced by the cited references teaching the combination of elements as well as the individual elements themselves, that transforms the claimed judicial exception into a patent-eligible application of the judicial exception.
With respect to the instant claims, the steps (analyzing fetal DNA and comparing with parent genomes for SNPs) and additional elements (cFC, SNPs, genetic markers, computer, non-transitory computer-readable medium) involving mathematical relationships and automated mental steps do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 1, 3-16, 18, 23, and 25 are not patent eligible.
Response to Arguments - Rejections Under 35 USC § 101
Applicant's arguments (p8-13), filed 06/26/2025, have been fully considered and are not persuasive for the previously stated reasons in the 01/27/2025 Office Action, with additions necessitated by claim amendments. The Applicant asserts:
Specifically, amended claim 1 recites " "(f) determining, using the probabilistic model, probabilities of three scenarios: the fetal cellular DNA obtained from the pregnant female originates from (1) the fetus in the current pregnancy, (2) the fetus in the historical pregnancy and having a same father as the fetus in the current pregnancy, and (3) the fetus in the historical pregnancy and having a different father from the fetus in the current pregnancy.'' …Applicant also submits that considering the 3 scenarios listed in claim 1 is not routine or conventional, instead providing an inventive concept that amounts to significantly more than any alleged judicial exceptions under Step 2B. The cited art does not teach the 3 scenarios of claim 1, such that it is not routine or conventional to obtain probabilities of "(1) the fetus in the current pregnancy, (2) the fetus in the historical pregnancy and having a same father as the fetus in the current pregnancy, and (3) the fetus in the historical pregnancy and having a different father from the fetus in the current pregnancy," as recited in amended claim 1. Obtaining probabilities of these three scenarios improves bioinformatics by improving the analytical sensitivity of non-invasive pre- natal testing (NIPT), facilitating a reduced sequencing depth and thus lower-cost testing. See [00125] of the present specification. See also Figures 13 and 14 and [00355-356], illustrating probability distributions for each scenario. Without considering these scenarios, fetal cellular DNA would be more likely to be misclassified, increasing costs of NIPT to properly identify fetal cellular DNA from the fetus in the current pregnancy. Thus, claim 1 provides a more efficient method for identifying fetal cellular DNA originating from a fetus in a current pregnancy, which constitutes technological improvements and an inventive concept… Applicant respectfully notes that the output of the probabilistic model is separate from the probabilistic model itself, and that the limitations of dependent claims 6-15 should not be imputed to claim 1. While claims 6-15, in isolation, may recite mathematical concepts, that does not necessarily imply that limitations of claim 1 recite a mathematical concept. Silver supports this conclusion, as the PTAB found claim 1 to not recite mathematical concepts but noted that claims 3-6 did recite ineligible mathematical concepts. Whether present claims 6-15 recite an ineligible mathematical concept is irrelevant to the eligibility of claim 1. Furthermore, Applicant respectfully submits that eligibility is not dependent upon whether a limitation is "clearly derived from mathematical equations/concepts," but whether it recites a mathematical concept. M.P.E.P. 2106.04(a)(2)(I) specifically cautions examiners to consider whether a claim recites a mathematical concept or merely limitations that are based on or involve a mathematical concept. A limitation that is merely based on or involves a mathematical concept does not recite an ineligible mathematical concept… Applicant understands that Silver is non-precedential, Applicant respectfully submits that the reasoning in Silver is equally applicable to the present claims. As noted above, Silver found there is not equation, formula, or specific calculation recited in the claim, and thus the claim does not recite a mathematical concept. Applicant respectfully submits that claim 1, and specifically step (f), similarly does not recite an equation, formula, or specific calculation.
However, the arguments with respect to ex Parte Silver have been considered but are not persuasive. As previously discussed, PTAB decisions are not precedential, and do not supersede examination guidance from the MPEP unless specifically made precedential. As Applicant is aware, according to MPEP 2106 In re Grams, a mathematical concept does not have to have an actual algorithm to be identified as mathematical:
“It is important to note that a mathematical concept need not be expressed in mathematical symbols, because "[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). See, e.g., SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018) (holding that claims to a ‘‘series of mathematical calculations based on selected information’’ are directed to abstract ideas); Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea); and Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012) (identifying the concept of ‘‘managing a stable value protected life insurance policy by performing calculations and manipulating the results’’ as an abstract idea)”
Claims 1 and 25 recite “providing as input to a… determining, using the probabilistic model, probabilities of three scenarios: the fetal cellular DNA obtained from the pregnant female originates from (1) the fetus in the current pregnancy,(2) the fetus in the historical pregnancy and having a same father as the fetus in the current pregnancy, and (3) the fetus in the historical pregnancy and having a different father from the fetus in the current pregnancy” and “determining, from the output of the probabilistic model, whether the fetal cellular DNA originates from the fetus in the current pregnancy.” Whether the genotype data analyzed in the probabilistic model indicate one scenario of the three claimed scenarios, these scenarios represent steps “using the probabilistic model” to calculate the probabilities [0013: the probabilistic model calculates the probabilities of the three scenarios given the number of shared genetic markers as follows… probability of the number of shared genetic markers given scenario i, p(si) is an overall probability of scenario i, and p(k) is an overall probability of the number of shared genetic markers], based on beta-binomial distribution [0016: the probabilistic model simulates the number of shared genetic markers given scenario i, or k as a random variable drawn from a beta-binomial distribution] and posterior probabilities [0035: the method further includ[e]s providing prior probabilities of the three scenarios to the probabilistic model, wherein the probabilistic model provides posterior probabilities of the three scenarios based on the prior probabilities of the three scenarios]. Said probabilistic model is a mathematical concept, the judicial exception because it is a statistical analysis for probability determination, as disclosed in the instant specification [see below Figure 4, 0056]:
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Further, the broadest reasonable interpretation and as defined in the art, the term “probabilistic model”, is a mathematical statistical model referring specifically to probabilities, see below:
A statistical model is a mathematical model that embodies a set of statistical assumptions concerning the generation of sample data (and similar data from a larger population). A statistical model represents, often in considerably idealized form, the data-generating process. When referring specifically to probabilities, the corresponding term is probabilistic model. All statistical hypothesis tests and all statistical estimators are derived via statistical models. More generally, statistical models are part of the foundation of statistical inference. A statistical model is usually specified as a mathematical relationship between one or more random variables and other non-random variables. As such, a statistical model is "a formal representation of a theory"… [from Wikipedia, redirected from “Probabilistic model”]
These three resulting scenarios, i.e. probabilities determined using said probabilistic model, are not additional elements which can integrate the judicial exception or provide an inventive concept, as the scenarios results are themselves the abstract and mathematical judicial exceptions.
Applicant respectfully submits that the present claims are patent-eligible for similar reasons as discussed in Koninklijke. Claim 1 recites specific means and methods to solve a technological problem. As described in the present specification, fetal cellular DNA is useful for non-invasive prenatal testing (NIPT). See [00124-130]. However, circulating fetal cells exist in maternal blood in very low concentrations and fetal cells from prior pregnancies may persist in maternal blood long after a prior pregnancy ends. Id. Thus, there is a technological problem of reliably identifying the origin of circulating fetal cells obtained from a pregnant women's blood as from the current pregnancy or a prior pregnancy. Id. The present claims present a specific means to solving this technological problem. The claims describe determining probabilities of three different scenario…Without considering these scenarios, fetal cellular DNA would be more likely to be misclassified, increasing costs of NIPT to properly identify fetal cellular DNA from the fetus in the current pregnancy. Claim 1 does not recite merely a result, such as determining the origin of fetal cellular DNA, but instead recites a specific means to improve genetic origin determination using the three scenarios. Applicant also respectfully submits that the present claims recite a specific implementation that improves the functioning of the overall technological process of NIPT testing… present claims do not merely recite a desired result of improving genetic origin detection, but recite a specific solution for accomplishing this task determining the probabilities of three different scenarios. The claims thus capture the improvement over prior art techniques by reciting specific improvements in determining circulating fetal cell genetic origin…
However, Applicant’s assertion improvement, is respectfully traversed as all the necessary and sufficient steps required to achieve the improvement are not clearly present. [0140+] . In claim 1, steps of (c-f) provide for current pregnancy fetal genotype and maternal genotype, but do not clearly recite the steps to obtaining the paternal genotype with the necessary statistical assumptions, whether in the current or in the historical pregnancy. According to MPEP 2106.05(a): “An important consideration in determining whether a claim improves technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102- 03; DDR Holdings, 773F.3d at 1259, 113 USPQ2d at 1107.” Further, the MPEP sets forth that “if the examiner concludes the disclosed invention does not improve technology, the burden shifts to applicant to provide persuasive arguments supported by any necessary evidence to demonstrate that one of ordinary skill in the art would understand that the disclosed invention improves technology. Any such evidence submitted under 37 CFR 1.132 must establish what the specification would convey to one of ordinary skill in the art and cannot be used to supplement the specification.” (see MPEP 2106.05(a) Improvements to the Functioning of a Computer or To Any Other Technology or Technical Field). Applicant’s arguments cannot take the place of evidence.
Applicant respectfully submits that the present claims do not merely recite collecting information and analyzing it [SAP America], but rather the present claims specifically describe how to improve cFC origin determination by using the three scenarios described above and recited in claim 1. The present claims recite a specific way of improving genetic origin determination by determining the probabilities of three different scenarios. The claims thus recite more than mere results, but a method of achieving such results…Applicant has also amended claims 1, 25, and 26 to recite "determining, using the probabilistic model, probabilities of three scenarios, to address concerns made by the examiners during the examiner interview that step (f) may be considered as insignificant extra-solution activity. Applicant submits that unamended step (f) is not mere insignificant extra-solution activity, but has amended claims 1 and 25 to more clearly indicate that step (f) is not mere data gathering.
However, it is respectfully submitted that Applicant’s assertion is not persuasive as discussed above regarding improvement to cFc origin determination. Whether the step (f) is an output that is obtained or determined, the scenarios are based on said probabilistic model, and therefore part of the judicial exceptions, abstract or mathematical concepts. Further “it is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.” (see MPEP 2106.05(a) emphasis added).
Examiner acknowledges Applicant’s arguments which set forth that the claims lead to an improvement in cFc origin determination. According to the guidance set forth in MPEP 2106, this is an improvement to the judicial exception itself, and is not reflected back into a specific technological environment or practically applied process. An improvement in the judicial exception itself is not an improvement in the technology. For example, in In re Board of Trustees of Leland Stanford Junior University, 989 F.3d 1367, 1370, 1373 (Fed. Cir. 2021) (Stanford I), Applicant argued that the claimed process was an improvement over prior processes because it ‘‘yields a greater number of haplotype phase predictions,’’ but the Court found it was not ‘‘an improved technological process’’ and instead was an improved ‘‘mathematical process.’’ The court explained that such claims were directed to an abstract idea because they describe ‘‘mathematically calculating alleles’ haplotype phase,’’ like the ‘‘mathematical algorithms for performing calculations’’ in prior cases. Notably, the Federal Circuit found that the claims did not reflect an improvement to a technological process, which would render the claims eligible (FR89 no.137, p58137, 7/17/2024).
Here, Applicant has provided an improved mathematical process of cFc origin determination, which is then used in the improved mathematical process for “NIPT to properly identify fetal cellular DNA from the fetus in the current pregnancy.” As above, said claims are merely executing the judicial exception, abstract ideas in the form of mathematical concepts (probabilities as input/output from probabilistic models) and are therefore, part of the abstract idea and cannot impart an inventive concept. (see MPEP 2106.05 "an inventive concept 'cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself.' Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016)." Therefore, claims 1, 3-16, 18, 23, and 25, remain rejected under 35 USC 101 because the claimed inventions are not directed to patent eligible subject matter. Any newly recited portions above are necessitated by claim amendments.
Conclusion
No claims are allowed.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting following form via EFS-Web or Central Fax (571-273-8300): PTO/SB/439. Applicant is encouraged to do so as early in prosecution as possible, so as to facilitate communication during examination.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vy Rossi, whose telephone number is (703) 756-4649. The examiner can normally be reached on Monday-Friday from 8:30AM to 5:30PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached on (571) 272-2249. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public.
/VR/
Examiner
Art Unit 1685
/MARY K ZEMAN/ Primary Examiner, Art Unit 1686