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 Claims
Claims 2-5, 8-11, 14, 15, 19-29, 31, 32, 34, 36-40, 44, 45, 49 and 51-54 are cancelled.
Claims 1-3, 6, 7, 12, 13, 16-18, 30, 33, 35, 41-43, 46-48 and 50 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statements filed 11/21/2023; 2/29/2024; 1/9/2025 are acknowledged. A signed copy of the corresponding 1449 form has been 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 41-43 and 46-48 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The instant claims are directed toward a system comprising a computer program. The claim does not recite any structural limitations of the system, therefore the claim encompasses a program per se, and encompasses code carried on a signal or carrier wave. The program code is not limited to be recorded on a statutory device or non-transitory computer-readable medium. Applicant is reminded that programs and signals, per se, are not statutory subject matter. See, e.g., In re Nuitjen, Docket no. 2006-1371 (Fed. Cir. Sept. 20, 2007)(slip. op. at 18)(“A transitory, propagating signal like Nuitjen’s is not a process, machine, manufacture, or composition of matter.’ … Thus, such a signal cannot be patentable subject matter.”).
Claims 1-3, 6, 7, 12, 13, 16-18, 30, 33, 35, 41-43, 46-48 and 50 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea/law of nature/natural phenomenon without significantly more.
In accordance with MPEP § 2106, the claims are found to recite statutory subject matter (Step 1 : YES). As a result, the claims are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea/law of nature/natural phenomenon:
Claims 1, 6, 41, 46 recite
comparing to a reference genome sequence a portion of a plurality of first sequence datasets (mental step)
comparing to a reference genome sequence a portion of a plurality of second sequence datasets (mental step)
determining an average normalized occupancies of digestion protected regions of nucleic acid fragments per genomic region (O1, O2, On) (mental and mathematical concept)
determining one or more stable nucleosome regions comparing to a first/second threshold (mental step)
comparing stable nucleosome regions of first subjects with second subjects (mental step)
identifying regions of the genome with stable nucleosome regions which have a difference between average normalized occupancy that is larger or smaller than a threshold value resulting in identifying condition sensitive genomic regions (mental step)
Claim 48 recites the judicial exceptions of claim 1 and further recites
Defining characteristics for a set of regions (mental step)
Aligning sequence data to a reference genome (mental step)
Calculating a normalized occupancy of cfDNA per genomic region (mathematical concept - calculation)
creating reference set of samples (mental)
calculating average normalized occupancy of cfDNA (mathematical concept-calculation)
performing dimensionality reduction analysis (mathematical concept -calculation)
performing a classification of a sample based on average normalized cfDNA occupancy (mental)
The dependent claims recite similar judicial exceptions or further clarify the judicial exceptions noted above. These recitations are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then if falls within the “Mental processes” grouping of abstract ideas. As such, claims 1-3, 6, 7, 12, 13, 16-18, 30, 33, 35, 41-43, 46-48 and 50 recite an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 1 : YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies or uses the recited judicial exception to effect a particular treatment for a condition. Rather, the instant claims recite additional elements that amount to mere instructions to implement the abstract idea in a generic computing environment or mere instructions to apply the recited judicial exception via a generic treatment. Specifically, the claims recite the following additional elements:
Claim 18 recites obtaining sequence data
Claim 48 recites obtaining sequence data
Obtaining data is mere data gathering and considered insignificant, extra-solution activity that is not significantly more than the judicial exceptions. MPEP 2106.05(g). There are no limitations that indicate that the claimed system comprise anything other than generic computer program. As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.
As such, claims XXX is/are directed to an abstract idea/law of nature/natural phenomenon ( Step 2A, Prong 2 : NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment. The instant claims recite the following additional elements:
Claim 18 recites obtaining sequence data
Claim 48 recites obtaining sequence data
Obtaining data is mere data gathering and considered insignificant, extra-solution activity that is not significantly more than the judicial exceptions. MPEP 2106.05(g). As discussed above, there are no additional limitations to indicate that the claimed analysis engine requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. The limitation for treating the tumor cells equate to mere instructions to apply the judicial exception in a generic way because the treating step is so generically recited. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. The additional elements 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, 6, 7, 12, 13, 16-18, 30, 33, 35, 41-43, 46-48 and 50 are not patent eligible.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY D RIGGS II whose telephone number is (571)270-3062. The examiner can normally be reached m-f 8-5.
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. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686
Prosecution Insights