IP Law Daily, PATENT—D. Del.: Infringement cases to proceed against Tempus AI over patents covering technology cell-free DNA liquid biopsy tests, (Aug 31, 2026)

By Carolin Dennis, B.Sc., LL.B., LL.M.

Guardant Health, Inc.’s patent infringement claims survived the invalidity challenge because it plausibly established inventive concept.

In a patent infringement dispute, the federal district court in Delaware denied a medical data processing company’s motions to dismiss the amended complaints filed by the patent owner. The district court found that the patent owner sufficiently alleged that all the eight patents contain inventive concepts that make them eligible, even though they rely on the naturally occurring presence of cell-free DNA (Guardant Health, Inc. v. Tempus AI, Inc., No. 24-687-GBW (D. Del. Aug. 26, 2026)).

Background. Guardant Health, Inc. (Guardant) owns U.S. Patent Nos. 11,149,306 (the ’306 Patent), 9,902,992 (the ’992 Patent), 10,501,810 (the ’810 Patent), 10,793,916 (the ’916 Patent), and 11,643,693 (the ’693 Patent) (collectively, 24-687 Patents). Guardant also owns U.S. Patent Nos. 12,116,640 (the ’640 Patent), 12,312,634 (the ’634 Patent), and 12,319,961 (the ’961 Patent) (collectively, 25-1013 Patents). The 24-687 Patents and 25-1013 Patents relate generally to technologies for analyzing cell-free DNA (cfDNA), DNA fragments released from cells of diverse organs and tissues, which circulate freely in the human bloodstream, to detect and characterize genetic alterations, including cancer associated variants. Guardant alleged that since its inception, Tempus AI, Inc. (Tempus) has capitalized on Guardant’s pioneering efforts to develop copy-cat cell-free DNA liquid biopsy tests. Guardant filed its First Amended Complaint (Amended Complaint) against Tempus asserting infringement of 24-687 Patents. Tempus moved to dismiss the Amended Complaint pursuant to Federal Rule of Civil Procedure 12(b)(6), asserting that the claims of the 24-687 Patents are directed to ineligible subject matter under 35 U.S.C. § 101. Guardant brought another action against Tempus asserting infringement of the 25-1013 Patents. The district court issued an order consolidating C.A. No. 25-1013 with C.A. No. 24-687 for all purposes on October 16, 2025. Thereafter, Tempus moved to dismiss the Complaint filed in C.A. No. 25-1013 pursuant to Federal Rule of Civil Procedure 12(b)(6), asserting that the claims of the 25-1013 Patents are directed to ineligible subject matter under 35 U.S.C. § 101.

Motion to dismissthe amended complaint in C.A. No. 24-687. The district court first analyzed whether Guardant plausibly alleged that the asserted claims of the ’992, ’810, and ’916 Patents (the ’992 Family Patents) and the ’306 Patent are directed to patent-eligible subject matter under Alice step one. At Alice step one, Tempus contended that the claims of the ’992 Family Patents and the ’306 Patent are directed to methods of observing natural phenomena-i.e., naturally occurring cfDNA. Tempus likened the claims in the present action to those in CareDX, Inc. v. Natera, Inc., 40 F.4th 1371 (Fed. Cir. 2022). Tempus asserted that, similarly to CareDx, the claims of the ’992 Family Patents and the ’306 Patent can be boiled down to: (1) collecting cfDNA from a biological sample, (2) performing conventional DNA sequencing, including after known preparation (tagging/amplification) methods, and (3) analyzing the cfDNA by known methods to (4) detect its natural genetic properties. The district court found that the claims of the ’992 Family Patents and the ’306 Patent are more similar to the claims in CareDx and are directed to the natural phenomenon of observing naturally occurring cfDNA.

At Alice step two, the district court noted that although the ’992 Family Patents and the ’306 Patent rely upon the naturally occurring presence of cfDNA, Guardant alleged that each patent discloses specific improvements in laboratory techniques, including tagging of cfDNA molecules, generation and identification of tagged parent polynucleotides, amplification and sequencing of tagged cfDNA molecules, and grouping or analysis of sequencing reads derived from those molecules, that were not routine, conventional, or well-understood at the time of the claimed inventions. Thus, accepting Guardant's allegations as true that the claimed elements were not well-understood, routine, or conventional, the district court found that Guardant has plausibly alleged an inventive concept.

Next, the district court first analyzed whether Guardant plausibly alleged that the asserted claims of the ’693 Patent are directed to patent-eligible subject matter under Alice step one. Tempus contended that the claims of the ’693 Patent recite a natural law-a natural correlation between cfDNA changes and cancer. The district court agreed and found that the final step of Claim 14, which consists of processing the mapped sequence to determine the likelihood that the subject has cancer merely amounts to analysis of the natural relationship between cfDNA and the likelihood of cancer. Thus, this step is directed to a law of nature-it merely analyzes an eternal truth that exists in principle apart from any human action. However, at Alice step two, Guardant plausibly pled that the asserted claims of the ’693 Patent contain an inventive concept. Specifically, Guardant alleged that the claimed invention employs a specific combination of differential probe capture yields and sequencing depths tailored to distinct target region sets, which improves existing methods in liquid biopsy analysis. The Amended Complaint further alleged that these methods were neither routine nor conventional and represented an improvement over prior art biopsy techniques. Thus, district court determined that at the motion to dismiss stage, Guardant’s allegations were sufficient to plausibly support its contention that the claimed methods employ an unconventional method and therefore recite an inventive concept.

Motion to dismiss the amended complaint in C.A. No. 25-1013. At Alice step one, Tempus contended that the asserted claims of 25-1013 Patents are directed to the natural phenomenon of detecting cancer and its associated genetic changes in order to monitor residual disease. The district court agreed with Tempus because just as the claims in CareDx recited a method for detecting cfDNA, the claims of the 25-1013 Patents recite methods for monitoring the presence or absence of a residual disease based on the detection of cfDNA molecules and genetic variation of cfDNA.

Tempus next asserted that the claims of the 25-1013 Patents lacked an inventive concept because the limitations they impose on the detection of natural phenomena are merely conventional. The district court found that for similar reasons as discussed with respect to the ’992 Patent, it cannot conclude, at this stage, that the ’961 Patent lacks an inventive concept. With respect to the ’634 Patent, the parties’ competing positions present a factual dispute concerning whether the ordered combination of the claimed steps was routine and conventional. The district court noted that at the motion to dismiss stage, factual disputes must be resolved in the favor of Guardant. Therefore, it concluded that Guardant has plausibly alleged an inventive concept.

Lastly, Guardant alleged that the ’640 Patent discloses a sequencing panel that was specifically designed to overcome deficiencies in prior art sequencing methods by increasing sequencing read depth and sensitivity, which enabled detection of low-frequency variants associated with residual disease. Tempus disputed that characterization and contended that the relevant sequencing and detection techniques were already conventional. The district court at this stage, viewing the complaint in the light most favorable to Guardant and accepting the allegations as true, determined that the ’640 Patent recited an inventive concept.

Accordingly, the Tempus’s motion to dismiss the amended complaint in C.A. No. 24-687 and C.A. No. 25-1013 were denied.

The Case is No. 24-687-GBW.

Judge: Williams, G.

Attorneys: David Ellis Moore (Potter Anderson & Corroon, LLP) for Guardant Health, Inc. Pilar Gabrielle Kraman (Stargatt & Taylor LLP) for Tempus AI, Inc.

Companies: Guardant Health, Inc.; Tempus AI, Inc.

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