DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 1-20 are directed to a system and method for generating a prediction of a trait of the target individual. 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 steps of generating a target feature vector that combines the set of DNA features of the target individual and the one or more non-DNA features. These steps are drawn to a mathematical algorithm or mental steps. Generating a vector that combines data and inputting the vector into a machine learning model, such as logistic regression, may be done by pen and paper. Furthermore, 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)). Dependent claims 2-9, 11-18 and 20 recite additional mental or mathematical steps or the data that is used in the judicial exception. 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 recite receiving a family tree, accessing a set of DNA features, accessing non-DNA features, and inputting a vector into a machine learning model. However, these are extra-solution data gathering steps. Extra solution data gathering steps are not sufficient to integrate the judicial exception into a practical application. The instant claims also recite a system, a graphical user interface, a computing server, processor, memory, and a non-transitory computer readable medium. However, the instant claims do not recite any structural limitations of these elements. 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 receiving a family tree, accessing a set of DNA features, accessing non-DNA features, and inputting a vector into a machine learning model. However, these elements are well-understood, routine, and conventional data gathering steps (Specification, pages 5-6 and 43-44). The instant claims also recite a system, a graphical user interface, a computing server, processor, memory, and a non-transitory computer readable medium. However, these elements are well-understood, routine, and conventional components of a computer (Specification, pages 5-6 and 43-44). 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.
Claim Rejections - 35 USC § 102
3. 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Macpherson et al. (US 2024/0371464 A1).
Regarding claims 1, 10 and 19, Macpherson et al. teach a system that includes a graphical user interface configured to receive a family tree defined by the target individua (paragraph [0044])l and comprising a family tree of individuals who are related to the target individual (paragraphs [0055]-[0058]; claim 1); a computing server in communication with the graphical user interface (paragraph [0026]) where the computing serves includes processors, memory, instructions and non-transitory computer readable medium (paragraphs [0023] - [0029]); accessing a set of DNA features of a target individual (paragraph [0039]; claim 1); accessing one or more non-DNA features from data associated with the family tree (paragraph [0064]; claim 1); generating a target feature vector that combines the set of DNA features of the target individual and one or more non-DNA features (paragraph [0079]; claim 1), and inputting the target feature vector to a machine learning model to generate a prediction of a trait of the target individual (paragraphs [0079]-[0085]).
Regarding claims 2 and 11, Macpherson et al. teach identifying community members who belong to the genetic community of the target individual (paragraph [0040]); determining a community prediction based on a prevalence of the trait among community members (paragraph [0040]); and revising or confirming the prediction of the trait based on the community prediction (paragraph [0040]).
Regarding claim 3 and 12, Macpherson et al. teach where the set of DNA features comprise a subset of DNA features that are disproportionately associated with related individuals in the target individual’s genetic community (paragraph [0038]) and a non-DNA feature that are disproportionately associated with the related individuals (paragraph [0064]).
Regarding claims 4, 13, and 20, Macpherson et al. teach normalizing a DNA feature or non-DNA feature (paragraph [0079]).
Regarding claims 5 and 14, Macpherson et al. teach where the trait is a disease (paragraph [0021]).
Regarding claims 6 and 15, Macpherson et al. teach where the machine learning model is a support vector machine (paragraph [0073]).
Regarding claims 7 and 16, Macpherson et al. teach where the DNA feature is determined based on the length of identity-by-descent segments (paragraphs [0038]-[0039]).
Regarding claims 8 and 17, Macpherson et al. teach the non-DNA features may include age or ethnicity (paragraph [0045]).
Regarding claims 9 and 18, Macpherson et al. teach that the prediction includes the probability that the target individual has a trait (paragraphs [0036] and [0037]).
Double Patenting
4. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
5. Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,896,742. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the US patent require all the limitations of the instant claims with additional limitations. The subject matter of the instant claims encompasses the US patent. Thus, the claims at issue are not patentably distinct from each other.
6. Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,735,290. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the US patent require all the limitations of the instant claims with additional limitations. The subject matter of the instant claims encompasses the US patent. Thus, the claims at issue are not patentably distinct from each other.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JERRY LIN/ Primary Examiner, Art Unit 1685
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