Tag: diagnosis

Does the “Patent Eligibility Restoration Act of 2023” Revive Diagnostic Claims?

On June 22, Senator Chris Coons, along with Thom Tillis introduced the “Patent Eligibility Restoration Act of 2023” (hereinafter “the Act”) to amend 35 USC s. 101 to clarify the scope of patent-eligible subject matter. Section 101(b) would be amended to delete “includes a new use of a known process” and insert “includes a use, application, or method of manufacture of a known or naturally occurring process.” A section (k) would be added to define the term “useful” as meaning that the invention or discovery has a “specific and practical utility” from the perspective of a POSA. So far, so good. The use of a naturally occurring process can be read to cover the use of a naturally occurring correlation, an “If A then B” claim. The recognition of the discovery of the utility of a naturally occurring correlation, which leads to a diagnostic conclusion would seem to be included in this broad language.

But now things get a bit sketchy. The Act would abolish all the current judicial, e.g. Chakrabarty, exclusions but would add a set of statutory exclusions that overlap the judicial exclusions in some places. The exclusions include “an unmodified human gene”—good-bye Myriad—and an unmodified natural material as that material exists in nature, e.g., water. This exclusion would not jeopardize diagnostic claims since a per se is not being claimed.

More troublesome, Section C of the exclusions would include a process that “occurs in nature wholly independent of, and prior to, any human activity.” Diagnostic claims are process claims that are based on the recognition of the utility of a correlation that takes place in the body. The utility of the diagnostic claim lies solely in the recognition of the utility of the correlation. If a man has an elevated level of PSA he is at risk of developing, or may already have, prostate cancer. But isn’t the relationship between PSA levels and cancer/no cancer a process that occurs in nature wholly independent of, and prior to, any human activity, such as sampling and measuring the level of PSA in the blood? Please read the Act and tell me why I am wrong.

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Saliva Test Predicts Prolonged Concussion Symptoms in Children

According to the American Academy of Pediatrics, although the majority of concussions that are diagnosed annually occur in children, clinical guidelines are usually based on adult concussion sufferers. The lack of guidelines may limit the ability of pediatricians to accurately predict the duration of a child’s symptoms, including headaches, fatigue, and concentration problems — which can interfere with school and other activities.

In many concussion cases, concussion symptoms last only a few days. However, up to 25 percent of children have prolonged concussion symptoms which can last for months.

Concussion Symptom Saliva Test Study Presented at Annual Meeting

New research presented at the 2017 Pediatric Academic Societies (PAS) Meeting suggests that a saliva test for children may offer answers as to how long concussion symptoms will last. Researchers presented an abstract of the study, “Peripheral microRNA patterns predict prolonged concussion symptoms in pediatric patients.” The PAS Meeting is produced through a partnership of four organizations: Academic Pediatric Association, American Academy of Pediatrics, American Pediatric Society, and Society for Pediatric Research.

Results of Concussion Symptom Saliva Test Study

Following a concussion, injured brain cells release fragments of genetic material (microRNAs) which show up in blood and saliva. Studies have found altered micro ribonucleic acids (miRNA) levels in the saliva of children with mild concussions. Similar miRNA changes have been found in cerebrospinal fluid of patients with severe brain injury.

Researchers at Penn State College of Medicine studied 50 children, ages 7 to 18 years old who experienced mild traumatic brain injury. Spit samples from each child were tested for miRNA levels. Concussion symptoms were evaluated through the parent and child Sports Concussion Assessment Tool (SCAT-3) surveys.

Researchers found that salivary miRNA levels were more effective than SCAT-3 surveys in predicting which children would continue to experience concussion symptoms that lasted longer than four weeks. The SCAT-3 surveys were less than 70 percent accurate in identifying children who would have prolonged concussion symptoms. The miRNA saliva test correctly predicted whether concussion symptoms would last for at least a month nearly 90 percent of the time.

The saliva-based RNA testing indicates the potential for an accurate and non-invasive method to evaluate pediatric concussions and provide a more accurate prognosis.

This post was written by Bruce H. Stern of STARK & STARK., COPYRIGHT © 2017
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