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 .
Claim Status
The response of 01/02/2026 has been entered. Claims 1, 3-8, 11, 13, 15-16, and 30-34 are currently pending in this US patent application and were examined on their merits.
Withdrawn Rejections
All rejections of claims 2, 20-22, and 25-26 set forth in the previous Office action are withdrawn in light of the amendment of 01/02/2026, which canceled these claims.
The rejection of claims 4-8, 15-16, and 30 under 35 U.S.C. 101 is withdrawn in light of further consideration by the Examiner. These claims are directed to the measurement of various biomarkers in blood, not to a diagnostic process of making a determination based on said measurement (which was recited in previous claim 2).
The rejections of the claims under 35 U.S.C. §§ 102(a)(1) and 103 set forth in the previous Office action are withdrawn in light of the amendment of 01/02/2026, which amended claim 1 to require the measurement of a particular group of biomarkers.
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 11 and 13 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on January 7, 2019 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)). This guidance indicates that claims must pass an eligibility test to avoid rejection under 35 U.S.C. 101. Under this test, the product must (a) not be directed to a judicial exception or must (b) contain additional elements that amount to significantly more than the judicial exception itself.
‘Directed to a judicial exception’ analysis:
Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties. Non-limiting examples of characteristics that can determine the presence of a marked difference include biological or pharmacological functions or activities; chemical and physical properties; phenotype, including functional and structural characteristics; and structure and form, whether chemical, genetic, or physical.
The cited instant claims recite the relationship between the levels of particular natural substances in the blood and a patient’s susceptibility to certain treatments, which is a natural correlation, a law of nature, and an abstract idea. As such, the cited instant claims recite a judicial exception. Limitations of the subject or of the particular disease indicated by particular levels of biomarkers do not result in a marked difference from the judicial exception because these limitations still result in claiming relationships between the levels of particular natural substances in the blood and a patient’s susceptibility to certain treatments.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 11 and 13 do not recite any application steps following the determination of the relationship between the measured biomarker levels and the patient’s having particular diseases.
‘Significantly more’ analysis:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements recited in the claims involve the recitation that, in the most narrow embodiment, LC-MS is used in the determination of the blood level of the biomarker. This step represents mere data gathering, which the courts have determined does not amount to significantly more than a judicial exception. See MPEP § 2106.05(g).
Therefore, claims 11 and 13 are directed to subject matter that is not patent-eligible and are rejected under 35 U.S.C. 101.
Allowable Subject Matter
The closest prior art to the claimed invention is found in the teachings of Tefas, as discussed in the previous Office action. However, Tefas does not teach or suggest measuring the five specific biomarkers recited in amended claim 1. As such, the claims are free of the prior art.
Response to Arguments
Applicant states that the amendment to claims 11 and 13 free these claims from the basis of rejection under 35 U.S.C. 101 set forth in the previous Office action (remarks, page 5). This argument has been fully considered but has not been found persuasive because the amendment of 01/02/2026 did not address the reasons for the rejections of claims 11 and 13 under 35 U.S.C. 101.
As such, the Examiner has maintained the rejections presented above.
Conclusion
Claims 1, 3-8, 15-16, and 30-34 are allowed. Claims 11 and 13 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 02/19/2026