DETAILED ACTION
Request for continued examination (RCE) of the application filed on 04/02/2026, is acknowledged. No amendment was made to the claims. Claims 4-5 and 50-66 are pending in the application and are considered on merits.
In response to the request, the examiner establishes rejection under 35 U.S.C. 101.
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 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.
Claim 4-5 and 50-66 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (a law of nature) without significantly more.
Step 2A – Prong One: The Claim Recites a Judicial Exception
Independent claim 4 recites, inter alia:
“measuring the levels of trihexosylceramide 34:1 … in a biological sample”
“comparing the levels … with a reference”
“wherein an altered amount … provides an indication” of various clinical outcomes
Similarly, claim 5 recites measuring sphingomyelin 40:2 and making the same type of comparison and inference.
The claims therefore describe a relationship between:
the level of a biomarker (TriHexCer 34:1 or SM 40:2), and
a disease state or clinical characteristic (e.g., risk, progression, prognosis, treatment outcome).
This relationship is a natural law, i.e., a naturally occurring correlation between biomarker levels and disease characteristics. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).
Accordingly, the claims recite a judicial exception.
Step 2A – Prong Two: The Claim Does Not Integrate the Exception into a Practical Application
The additional elements beyond the judicial exception include:
“measuring … using an in vitro assay”
“comparing … with a reference”
These steps merely involve:
collecting data (measurement), and
analyzing/interpreting the data (comparison and inference).
Such steps are well-understood, routine, and conventional activities in the field of clinical diagnostics and do not impose any meaningful limit on the judicial exception.
The claims do not:
recite a specific improvement in assay technology,
require a particular non-conventional detection technique, or
apply the correlation in a manner that effects a transformation or other practical application beyond merely reporting the result.
Instead, the claims simply instruct a practitioner to:
observe a natural correlation and report its meaning.
Therefore, the claims do not integrate the judicial exception into a practical application. See MPEP §2106.04(d).
Step 2B – No Inventive Concept
The additional elements—measuring biomarker levels and comparing them to a reference—are well-understood, routine, and conventional in the field.
For example, claim 55 explicitly lists standard analytical techniques such as:
mass spectrometry,
liquid chromatography-mass spectrometry (LC-MS),
nuclear magnetic resonance (NMR), etc.
These are generic tools routinely used to measure biomolecules.
When considered individually and as an ordered combination, the additional elements:
do not add any unconventional technical feature, and
merely implement the natural law using routine laboratory techniques.
Thus, the claims amount to no more than instructions to apply a natural law using conventional steps, which is insufficient to constitute an inventive concept under Mayo.
Conclusion
The claims are directed to a natural law (the correlation between biomarker levels and prostate cancer characteristics) and do not include additional elements that amount to significantly more than the judicial exception.
Accordingly, claims 4-5 and 50-66 are ineligible under 35 U.S.C. §101.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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/XIAOYUN R XU, Ph.D./ Primary Examiner, Art Unit 1797
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