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 .
Applicant’s arguments, filed 9/29/2025, have 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.
Applicants have amended their claims, filed 9/29/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant has cancelled claims 2-5, 7,9-10, 12-20, 23-24, 26-38, 42, and 44-45 in the response filed 9/29/2025.
Claims 1,6,8,11,21-22,25,39-41,43 and 46-47 are the current claims hereby under examination.
Claim Rejections - 35 USC § 112
Response to Arguments
Applicant’s arguments, filed 9/29/2025, with respect to the rejection of claims under 112(a) and 112(b) have been fully considered and are persuasive because of applicant’s arguments and amendments to the claims. Therefore, the rejections have been withdrawn.
Claim Rejections - 35 USC § 101-Maintained/modified necessitated by amendment
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 1,6,8,11,21-22,25,39-41,43 and 46-47 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
the claimed invention is directed to determining whether a fetus has a chromosomal aneuploidy or a generating a classification model for doing so without significantly more.
Analysis of independent claims 1:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1 and 41 are directed to a method and claims 39-40 and 46 are directed to computer program stored on and executed by the computer, which describes one or more of the four statutory categories of patentable subject matter, i.e., a process/machine. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites an abstract idea. In particular, the claim recites the following:
a. obtaining sequence data from a pregnant woman;
b. determining a fetal fraction of the pregnant woman and an estimated fraction;
c. determining first and second features;
d. determining whether the fetus has an aneuploidy based on the first and second features.
These elements recited in claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper and/or they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations.
Step A involves the mental and/or mathematical step of using differences in sequencing reads, which can be performed mentally or using pen and paper. Steps B and C of determining first and second features and then the presence of a fetal aneuploidy further involve the mental and/or mathematical steps of generating observational data based a difference between an estimated fraction and a comparison chromosome and further generating a conclusion of the presence of an aneuploidy based on these first and second features using corresponding data of a control sample.
The identified abstract steps, recited at the high level of generality, do not suggest an undue level of complexity for a person with ordinary skill in the art to be practically performed in the human mind with the aid of pen and paper.
Prong Two: Claims 1 and 41 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea.
The additional elements merely:
a. Add insignificant extra-solution activity (e.g. the pre-solution activity of sequencing a pregnant woman sample to acquire nucleic acid sequencing data from a pregnant woman sample).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 41 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. e.g., all additional elements are directed to pre-solution, which merely facilitates the abstract idea. Furthermore, the additional element is simply the addition of an element that is considered routine, conventional, and well-known (e.g. data gathering), see applicants IDS submitted 9/30/2025 with regards to the Kim et al. reference (or copius Sequenome or Ariosa articles in the literature) that disclose the well-known, routine, and conventionally understood method of sequencing a pregnant woman sample to acquire nucleic acid sequencing data comprising cell-free fetal DNA.
Claim 41 has the same analysis above but with the additional abstract step of performing machine learning training to construct a machine learning classification model. The additional abstract step recited at such a high level of generality does not require any specifically undue complexity that cannot be performed with pen and paper by a person of ordinary skill in the art. Therefore, the additional step of using machine learning to generate a machine learning classification model is considered part of the JE and does not either integrate the JE into a practical application nor add significantly to the JE.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Analysis of other independent claims 39-40 and 46:
Claims 39-40 and 46 have the same analysis as above, but with the addition of the method being carried out on a program stored on a computer. Patenting abstract ideas cannot be circumvented by attempting to limit the use [the idea] to a particular technological environment. In the instant claims, the computer and/or program/product amount to mere instruction to implement an abstract idea. The hardware recited by the system claims do not offer a meaningful limitation beyond generally linking “the use of the method to a particular technological environment,’ that is, implementation via computers.” see Alice Corp v. CLS Bank Int’l 573 U.S. (2014).
Analysis of the dependent claims:
Claims 6, 8, 11, 21-22, 25, ,43 and 47 depend from the independent claims. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely describe additional details of determining fetal fractions, estimated fractions, first and second features, or further describe the acquired type of data.
Dependent claim 47 further describes aspects of the acquired data at steps (i)-(ii) and additional limitations of determining the first and second feature, which are further limitations of the identified abstract idea. Therefore, the limitations are not considered to integrate the JE into a practice application nor add significantly to the JE itself.
Response to Arguments
Applicant's arguments filed 9/29/2025 with respect to the rejection of claims under 25 USC 101 have been fully considered but they are not persuasive.
Applicant argues that the amendment to now include a physical measurement step (e.g. sequencing a pregnant woman sample to acquire nucleic acid sequencing data) that is not limited to the execution by a computer program or mental calculation converts said claims into eligible subject matter.
Applicant arguments are not found persuasive as described above wherein the amended step has been interpreted as the addition of essentially both as an insignificant data gathering step and a step that is well-known, routine, and conventional in the prior art. Therefore, the claims remain considered to be directed to a recognized judicial exception and thus found to be read on ineligible subject matter.
Conclusion
No claim is allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Sims, whose telephone number is (571)-272-7540.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Jonathan Moffat can be reached via telephone (571)-272-4390
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 Central PTO Fax Center. The faxing of such papers must conform with 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 PTO Fax Center number is (571)-273-8300.
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/JASON M SIMS/ Supervisory Patent Examiner, Art Unit 3791