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 .
Status of the Claims
Claims 1-20 are under examination.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more.
Claims 1-20 are directed to method training a predictive model that parameterizes state-transition probabilities between molecular state vectors conditioned on elapsed time. 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. The instant claims require the grouping sequencing reads, generating an error-corrected consensus sequence, constructing a molecular state vector, storing a plurality of ordered pairs including a first molecular state vector captured at a first time point and a subsequent molecular state vector captured at a second time point later, and training a predictive model that parameterizes state-transition probabilities between molecular state vectors condition on elapsed time. These steps are drawn to either mental steps or a mathematical algorithm. Dependent claims 2-20 are drawn to additional mental steps, mathematical steps or the type of data to be used in the judicial exception. Mental steps are a judicial exception. 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 clams include elements of a computer-implemented method, receiving sequencing reads, receiving a query molecular state vector, and generating messages. However, these steps are extra solution data gathering or outputting activity. Extra solution activity does not provide a practical application to a judicial exception. Furthermore, although the claimed invention is computer implemented, the instant claims do not recite any structural limitations of the computer. The instant claims do not recite a particular machine that integrates the judicial exception into a 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 additional elements of computer-implemented method, receiving sequencing reads, receiving a query molecular state vector, and generating messages. However, these elements are well-understood conventional and routine (Specification pages 21, 22 and 27-30). Reciting such well-understood, routine, and conventional elements do not transform a 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 the types of data for a data gathering step. Thus, the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Examiner Note:
The closest prior art is Tseng et al., “Dynamic Plasma EGFR Mutation Status as a Predictor of EGFR-TKI Efficacy in Patients with EGFR-Mutant Lung Adenocarcinoma” Journal of Thoracic Oncology, (April 2015) volume 10, number 4, pages 603-610). While Tseng et al. teach generating a predictive algorithm to determine the probability that a first state will result in a second state (pages 606-608), Tseng et al. does not teach grouping sequencing reading into families according to sequence tags, generating error-corrected consensus sequence, constructing a molecular state vector from the consensus sequences, and training a predictive model.
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