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 amendment of 12/24/2025 has been entered. Claims 1, 3, 5-8, and 14 are pending in this US patent application. Claim 8 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/31/2025.
Claims 1, 3, 5-7, and 14 are currently under examination and were examined on their merits.
Withdrawn Rejections
All rejections of claims 2, 4, and 9-13 set forth in the previous Office action are withdrawn in light of the amendment of 12/24/2025, which canceled these claims.
The rejection of claims 1 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by Corrales Izquierdo as set forth in the previous Office action is withdrawn in light of the amendment of 12/24/2025, which added multiple limitations to claim 1.
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, 3, and 5-7 remain rejected, and claim 14 is newly rejected as necessitated by amendment under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Please note that the rejection of claims 1, 3, and 5-7 has been slightly augmented to incorporate discussion of the newly-added limitations from the amended claims of 12/24/2025. However, because the basis of the rejection is unchanged, this rejection has been maintained.
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 claims are drawn to a method of testing for nonalcoholic steatohepatitis (NASH) comprising a step of measuring oxidized ApoA-I modified by dioxidation at W72 in a biological sample from a patient, wherein the patient is likely to have developed NASH when the abundance of the oxidized ApoA-I is about a certain threshold as compared to a control sample. As such, the claims depend on the relationship between the presence of NASH in a subject and the level of oxidized ApoA-I in a sample from the subject, which is a natural correlation, a law of nature, and an abstract idea. Accordingly, this relationship is a judicial exception. Various dependent claims recite additional relationships—between the abundance of oxidized ApoA-I and steatosis and between the ratio of oxidized ApoA-I to total ApoA-I—all of which are also judicial exceptions for the reasons detailed above. As such, the instant claims recite judicial exceptions.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
The instant claims do not recite any application of the judicial exceptions. The judicial exceptions are simply measured in the claims and are not applied in any way.
‘Significantly more’ analysis:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps of measuring the judicial exception recited in the instant claims are recited generally and represent insignificant extra-solution activity (i.e., simple measurement that is required to observe the judicial exception) that does not amount to significantly more than the recited judicial exception. See MPEP § 2106.05(I)(A).
Therefore, claims 1, 3, 5-7, and 14 are directed to subject matter that is not patent-eligible and are rejected under 35 U.S.C. 101.
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 U.S.C. 101. Applicant states that the claims are not directed to a judicial exception because they are limited in a meaningful way by reciting a particular sample, a particular marker, and a particular way of assessing those markers. Applicant says that this method of assessing clinical risk for NASH is not simply an observation or detection of a natural phenomenon but, rather, a new and useful method that results in a less invasive method of detecting NASH (remarks, pages 4-5). This argument has been fully considered but has not been found persuasive.
The Examiner notes that measuring a judicial exception is not a “practical application” of said exception—it is not an application of the exception at all. As such, the particular judicial exception that Applicant is measuring (i.e., the relationship between a particular marker in a particular sample and the presence of a particular disease) is not relevant to whether or not the claims integrate a judicial exception into a practical application. Additionally, discovering a new judicial exception, such as the relationship between W72 oxidized ApoA-I and NASH, does not make the judicial exception patent-eligible. The Examiner further notes that the instant claims contain no steps following the judicial exception step of diagnosis and that the measuring steps performed are well-understood, routine, and conventional in the art (see, for example, US patent application publication 2008/0090223 as discussed in the previous Office action). The Examiner recommends that Applicant include a practical application of the diagnosis, such as the administration of a particular treatment, into the claims.
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 03/20/2026