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
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 10, 2025 has been entered.
Status of the Claims
Claims 1, 2, 4-11, 13, 14, and 16-19 are under examination.
Claim Rejections - 35 USC § 101
2. 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 10, 11, 13, 14, and 16-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 10, 11, 13, 14, and 16-19 are directed to method of detecting circulating tumor DNA in a biological sample. As described in Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 573 U.S._, 134 S. Cr. 2347, 110 U.S.P.Q.2d 1976 (2014), a two-step analysis is required in considering the patent eligibility of the claimed subject matter. The first step requires determining if the claimed subject matter is directed to a judicial exception. Using the claim interpretation provided above where the second analysis is not a requirement of the instant claims, the instant claims require performing a first analysis of protein biomarker information that was derived from a first assay performed on a biological sample by applying a first machine learning model to identify whether the biological same is not at risk of containing circulating tumor DNA and perform a second analysis comprising analyzing sequence information from the biological sample or an additional biological sample obtained from the subject by applying a second machine learning model to detect the presence of circulating tumor DNA. The analysis of nucleic acid sequence information and applying a machine learning model are a mathematical algorithms (Specification, pages 37 and 38). The courts have found mathematical algorithms to be drawn to the judicial exception of an abstract idea (In re Grams, 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)). Thus, the instant claims are drawn to a judicial exception.
This judicial exception is not integrated into a practical application. The instant claims do not recite an element that reflects an improvement in the functioning of a computer or other technology, an element that applies the judicial exception to effect a particular treatment, an element that implements the judicial exception with a particular machine, or an element that effects a transformation of a particular article to a different state or thing. The instant claims also recite performing an immunoelectrochemiluminescence assay and performing sequencing . However, these steps are extra solutional data gathering steps. Extra solutional data gathering steps do not provide a practical application for the judicial exception. Thus, the instant claims do not integrate the judicial exception into practical application.
The second part of the analysis requires determining if the claims include additional elements that are sufficient to amount to significantly more than the judicial exception. The instant claims recite the elements of an immunoelectrochemiluminescence assay and sequencing. However, these elements are well-understood, conventional, and routine (paragraphs [00184]-[00188] and [00195]). Reciting well-understood conventional elements do not transform the judicial exception into patent eligible subject matter. In addition, the recitation of the specific types of data, to be used in the judicial exception does not transform the abstract idea into a non-abstract idea. (See buySAFE, Inc. v Google, Inc. 765 F.3d 1350, 112 U.S.P.Q.2d 1093 (Fed.Cir.2014)). Furthermore, the elements taken as a combination are also well-understood, routine, and conventional, since the elements are merely specifying a general purpose computer for implementing the judicial exception. Thus, the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Response to Arguments
3. Applicants have amended claim 1 to include an apparatus for performing an immunoelectrochemiluminescence assay and a sequencer. These elements are drawn to a particular machine, which would provide a practical application to the judicial exception. This rejection is withdrawn as it was applied to claims 1, 2, and 4-9.
Applicants first state the instant claims do not recite a mathematical algorithm. Applicants cite example 39 of the August 4th, 2025 memo to state that training a neural network may involve a mathematical concept, but it does not recite a mathematical algorithm. However, the instant claims recite applying a machine learning model which is distinguishable from training a neural network. A machine learning model is a mathematical algorithm, where training a neural network may involve a broad array of techniques that rely on mathematical concepts. Thus, the instant claims do recite a mathematical algorithm in the form of a machine learning model.
Applicants state that the instant claims that performing a first analysis and performing the second analysis provides an improvement in detecting circulating tumor DNA. However, this improvement is an improvement of the analysis itself, which is drawn to a judicial exception. An improvement in the judicial exception is not an improvement in a technology. Thus, the instant claims do not provide an improvement that integrate the judicial exception into practical application.
Applicants state that the combination of a particular type of machine, a particular way of preforming the first analysis, and a particular way of performing the second analysis is not well-understood, conventional or routine. While instant claim 1 recite a particular machine, instant claims 10, 11, 13, 14, and 16-19 do not recite a particular machine. Instant claims 10, 11, 13, 14, and 16-19 recite the elements of an immunoelectrochemiluminescence assay and sequencing. However, these elements are well-understood, conventional, and routine (paragraphs [00184]-[00188] and [00195]). Thus the instant claims do not recite an element that is not well-understood, conventional and routine.
Allowable Subject Matter
Claims 1, 2, and 4-9 are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JERRY LIN whose telephone number is (571)272-2561. The examiner can normally be reached T-F 7am-5pm.
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/JERRY LIN/Primary Examiner, Art Unit 1685