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 .
Election/Restrictions
Applicant’s election without traverse of the invention of Group I, claims 1, 3-5, and 7-9, in the reply filed on 03/25/2026 is acknowledged.
Claim Status
The amendment of 03/25/2026 has been entered. Claims 1, 3-5, 7-11, and 13-14 are pending in this US patent application. Claims 10-11 and 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 03/25/2026.
Claims 1, 3-5, and 7-9 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statements filed in this application on 12/11/2023 and 07/03/2025 have been received and considered.
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, 3-5, and 7-9 are 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.
Instant claim 1 recites a method of performing various measurements, calculating a variation, calculating an average, calculating a threshold, and comparing a measurement with the calculated threshold to determine whether or not a microorganism is present in a sample. The calculation steps are all abstract ideas, and the determination is an abstract idea and represents a natural correlation between the presence of a microorganism and the measured parameter. These abstract ideas and natural correlations are judicial exceptions.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
The additional elements recited in instant claim 1 and in all of its dependent claims represent measuring steps and necessary data gathering that are required for the performance of the determination, which is a judicial exception. As such, the additional elements in claim 1 and its dependent claims represent insignificant extra-solution activity, which does not serve to integrate judicial exceptions into a practical application. See MPEP §§ 2106.04 and 2106.05.
‘Significantly more’ analysis:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements in the claims that are not judicial exceptions represent insignificant extra-solution activity, as discussed above, which does not amount to significantly more than a judicial exception. See MPEP § 2106.05.
Therefore, claims 1, 3-5, and 7-9 are directed to subject matter that is not patent-eligible and are rejected under 35 U.S.C. 101.
Claims Are Free of the Prior Art
The closest prior art to the claimed invention is found in the teachings of Kurisuchiyan (Japanese patent document JP S53-139785 filed by Kurisuchiyan et al., published 12/06/1978; cited on the IDS filed 12/11/2023), who teaches a method for detecting bacteria in blood based on the presence of bacterial ATP in the sample, which is measured by the bioluminescence generated in the presence of luciferase and luciferin. The effect of background luminescence is removed by comparing measurements obtained with the test sample with measurements obtained with a control sample. Furthermore, the sample may be divided in portions to determine the bioluminescence of the sample at different culture times, and also under conditions in which the microorganisms are no longer viable by adding an antibiotic (see entire document, including claims). However, Kurisuchiyan does not teach or suggest using any one of these measurements for calculating a threshold using the equation recited in instant claim 1. As such, the instant claims are free of the prior art.
Conclusion
No claims are allowed.
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 06/25/2026
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