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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 20 July 2026 has been entered.
Priority
A claim of priority is made to the following provisional applications: 62/322,773, 62/322,784, 62/322,783, 62/322,775, 62/322,786, and 62/324,287. None of these provide support for interrogating methylation status in cfDNA molecules. They are all directed to detecting genetic variants in cfDNA. The earliest application that provides support for interrogation of methylation status in cfDNA molecules is PCT/US17/27809 filed 14 April 2017. This instant application therefore has a priority date of 14 April 2017.
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 1-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature or natural phenomenon without significantly more.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) 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:
Claim 1 recites a law of nature or natural phenomenon. The claims are drawn to detecting residual cancer after surgery. The method steps comprise enriching the sample from the subject, sequencing the cfDNA and determining methylation profiles and detecting the presence of absence of one or more genetic variants from the sequencing data. The methylation profile and the presence or absence of the one or more genetic variants is used to detect the presence or absence of residual disease in the subject. The claims are using the methylation status and genetic variation presence or absence to determine a state that is already present in the subject. The claims are only detecting it. Therefore, the claims are drawn to a law of nature or 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 affect a particular treatment for a condition. Rather, the instant claims recite additional elements that amount to mere instructions on how to detect the methylation status or genetic variant or what type of cancer the patient has.
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 on how to make the determination if the patient has residual cancer. They are routine and conventional process steps. Determining a methylation status or genetic variant using cfDNA was known in art. For example, Venn (US 2017/0213008 A1, filed 20 January 2017) teaches a method of tracking patient health. (claim 1). The method uses a nucleic acid sample of the patient and comparing the mutation signature for the patient to mutation signatures of patients with known health statuses and determining a diagnosis for the patient. (claim 1). Venn teaches the method can be used after a patient has had a tumor resection surgery. (claim 5). Venn teaches the investigation of methylation status and genetic variants. [0009].
Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 1-27 are not patent eligible.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MINDY G BROWN whose telephone number is (571)270-5605. The examiner can normally be reached Monday -Friday, 9:00 am - 5:00 pm EST.
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/MINDY G BROWN/Patent Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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