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Ameritox, Ltd. et al. v. Millennium Health, LLC

Representative Claim(s)

The ‘680 Patent

1. A method for quantifying at least one metabolite in a biological sample comprising the steps of:

(a) providing one biological sample obtained from a patient on a prescribed medication regimen, wherein the sample comprises at least one test metabolite, wherein in the sample is urine;

(b) providing one set of known normative data specific to a reference metabolite, wherein the set of data is collected from a population that is on a prescribed medication regimen;

(c) contacting the biological sample with an analytical device;

(d) detecting the presence of at least one test metabolite in the biological sample with the device, wherein the device is capable of measuring the concentration of the test metabolite in the sample;

(e) normalizing the biological sample to adjust for changes in the patient’s hydration status by determining the metabolite/creatinine ratio of the patient; and

(f) quantifying the concentration of at least one test metabolite in the biological sample by comparing a ratio between the concentration of the test metabolite from the patient to the set of known normative data specific to the reference metabolite concentration.

The ′895 Patent

1. A method for quantifying at least one metabolite in at least one biological sample comprising the steps of:

(a) providing at least one biological sample obtained from a patient on a prescribed medication regimen, wherein the biological sample comprises at least one test metabolite;

(b) providing one set of known normative data specific to a reference metabolite, wherein the set of data is collected from a population that is on a prescribed medication regimen;

(c) contacting the biological sample with an analytical device;

(d) detecting the presence of at least one test metabolite in the biological sample with the device, wherein the device is capable of measuring the concentration of the test metabolite in the at least one biological sample;

(e) normalizing the biological sample to adjust for changes in the patient’s hydration status by determining the metabolite/creatinine ratio of the patient; and

(f) quantifying the concentration of at least one test metabolite in the biological sample by comparing a ratio between the concentration of the test metabolite from the patient to the set of known normative data specific to the reference metabolite concentration.

Posture:

Motion for Summary Judgment

Exception Category: Abstract Idea

“While the skilled addressee would view comparative analysis of the invention as one that seeks to achieve a new and useful result over prior urine screening protocols, this new and useful result still rests upon an abstract idea, at least at some level. This finding is consistent with the recent BRCA1– decision, which also involved method claims.”

Significantly More: Yes / No

Yes (‘680 Patent), No (‘895 Patent)

The ‘680 Patent

“Ameritox argues that the claim elements are unconventional because the asserted claims are drawn to specific methods of monitoring medication through normalization and quantification of metabolites in a urine sample. Ameritox contends that these steps contain an inventive concept because the process described seeks to implement a novel solution to a pre-existing problem in the field.  …Indeed, much of Ameritox’s argument centers on the fact that: (1) the invention produces an improved result over existing technology; and (2) the necessary inventive concept is combining the normalization step with the detection and comparative steps. As to the ′680 patent, the court agrees.”

“First, when the invention is examined as an ordered combination, the combination of steps produces a new and useful result. 35 U.S.C. § 101 (the patent statute provides protection for ‘any new and useful process’). The instant case shares similarities with Diehr in this respect. In both cases, the subject patents are directed to abstract ideas that improve pre-existing technology. … This type of improvement in existing technology is the type of invention that the statute seeks to encourage, not dismiss.”

“Here, the ′680 specification states that previous urine protocols were restricted in their application because they could only test for positive or negative results as to the ‘presence or absence of a drug metabolite in urine.’ …This problem was described as a ‘major difficulty’ in the art because of the ‘large amount of variance in urine drug concentrations, mostly due to variations in hydration and urinary output volume.’ …In addressing the problem, the inventors coupled the normalization step with the comparative step, allowing for more accurate assessment of aberrant drug use”

“…evidence of combination helps to guard against hindsight bias. To ignore this concern would provide a ‘blank check’ to all those who challenge patents without sufficient legal or evidentiary basis. Given that Alice now expressly requires that courts look at patented elements in combination when assessing inventive concept (as did Mayo ), the concern of hindsight bias has as much relevance to a § 101 challenge as it does a § 103 challenge.”

The court found that that the use of creatine normalization was not routine or conventional in the field, and was in fact considered unreliable.  “If the seminal reference in the art at the time stated that blood sampling was by far preferable to urine normalization, because of the latter’s unreliability, why would anyone in the industry have thought to use a normalization step for urine in drug protocols? …Regardless, a normalization step that others skilled in the art had rejected as unreliable can hardly be considered conventional in the § 101 context. Moreover, it is this normalization step that distinguishes the present patent’s claims from the Mayo patent claims. The fact that the claims in the ′680 patent are even more specific—limiting their reach to creatinine normalization—further narrows their scope, especially since there were other means to adjust for changes in a patient’s hydration status.”

“Because the inventors cut against scientific thought at the time of the invention, and because the invention targeted a specific problem in the field of urine testing, the court finds that there is sufficient inventive concept in the ′680 patent for the purposes of meeting the threshold test of section 101.”

The ‘895 Patent

“None of this can be said with respect to the ′895 patent. On the contrary, the sweeping claim to ‘a method for quantifying at least one metabolite in at least one biological sample’ refers to nothing more than the claimed discovery of a method for ‘quantifying the concentration of at least one test metabolite in the biological sample’ against an unspecified and undisclosed ‘known normative data specific to the reference metabolic concentration.’ Unlike element (e) of the claims in the ′680 patent, there is no teaching against the art well-known at the time with respect to the use of creatinine concentration in urine, no specification of a similar test metabolite in other biological samples, or unique relationships between at least one biological sample obtained from a patient and a set of known normative data specific to the referenced metabolite concentration. In short, the ′895 patent merely deletes the limitation of the biological sample of urine leaving a sweeping claim to biological samples consisting of ‘blood, saliva, sweat, spinal and brain fluids.’ (′895 patent at 4:58–60.) …it amounts to nothing more than speculative claims that purport to preempt similar discoveries with respect to other biological samples. This would appear exactly the kind of preemption strongly disfavored by the United States Supreme Court because it ‘forecloses more future invention than the underlying discovery could reasonably justify.’ Mayo, 132 S.Ct. at 1301….”