District Court Finds Method of Detecting Claim to Be Directed to Patent Ineligible Subject Matter

By Donald Zuhn —

Earlier this month, in Cleveland Clinic Foundation v. True Health Diagnostics, LLC, District Judge Leonie M. Brinkema of the U.S. District Court for the Eastern District of Virginia granted a Motion to Reconsider filed by Defendant True Health Diagnostics, LLC ("True Health"), and dismissed Counts 1 and 2 of a complaint for patent infringement filed by Plaintiffs The Cleveland Clinic Foundation and Cleveland Heartlab, Inc. ("Cleveland Clinic") against True Health.  In its complaint, Cleveland Clinic alleged that True Health's procedures for diagnosing atherosclerotic cardiovascular disease infringed Cleveland Clinic's U.S. Patent Nos. 9,575,065; 9,581,597; and 9,612,242.  True Health responded by filing a motion to dismiss all three counts of the complaint, arguing that the '065 and '597 patents are directed to an unpatentable natural law, and that Cleveland Clinic failed to adequately plead infringement of the '242 patent.  The District Court denied True Health's motion, noting that an appeal before the Federal Circuit regarding the validity of all three asserted patents was still pending, and that absent a ruling from the Federal Circuit, additional factual discovery would likely be necessary to determine whether certain steps recited in the asserted claims were conventional.

Following resolution of the appeal in Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352 (Fed. Cir. 2017) ("Cleveland Clinic I"), in which the Federal Circuit affirmed a motion to dismiss granted by the District Court for the Northern District of Ohio, which in turn had found the asserted claims of four Cleveland Clinic patents to be directed to patent ineligible subject matter, True Health filed its Motion to Reconsider in the instant case.  Both the '065 and '597 patents (which were asserted in Counts 1 and 2 of Cleveland Clinic's complaint) claim the benefit of the application that issued as U.S. Patent No. 7,223,552, which was one of the four patents involved in the Federal Circuit appeal.  Claim 1 of the parent '552 patent recites:

1.  A method for characterizing a test subject's risk of having atherosclerotic cardiovascular disease, comprising:
    determining levels of myeloperoxidase (MPO) activity, myeloperoxidase (MPO) mass, or both in a bodily sample from the test subject, said bodily sample being blood, serum, plasma, blood leukocytes selected from the group consisting of neutrophils and monocytes, or any combination thereof,
    wherein elevated levels of MPO activity or MPO mass or both in the bodily sample of the test subject as compared to at least one predetermined value based on levels of MPO activity, MPO mass or both, respectively, in comparable bodily samples obtained from control subjects diagnosed as not having the disease indicates that the test subject is at risk of having atherosclerotic cardiovascular disease.

The sole claim of the '065 patent recites:

1.  A method of detecting elevated MPO mass in a patient sample comprising:
    a) obtaining a plasma sample from a human patient having atherosclerotic cardiovascular disease (CVD); and
    b) detecting elevated MPO mass in said plasma sample, as compared to a control MPO mass level from the general population or apparently healthy subjects, by contacting said plasma sample with anti-MPO antibodies and detecting binding between MPO in said plasma sample and said anti-MPO antibodies.

The only two claims of the '597 patent recite:

1.  A method for identifying an elevated myeloperoxidase (MPO) concentration in a plasma sample from a human subject with atherosclerotic cardiovascular disease comprising:
    a) contacting a sample with an anti-MPO antibody, wherein said sample is a plasma sample from a human subject having atherosclerotic cardiovascular disease;
    b) spectrophotometrically detecting MPO levels in said plasma sample;
    c) comparing said MPO levels in said plasma sample to a standard curve generated with known amounts of MPO to determine the MPO concentration in said sample; and
    d) comparing said MPO concentration in said plasma sample from said human subject to a control MPO concentration from apparently healthy human subjects, and identifying said MPO concentration in said plasma sample from said human subject as being elevated compared to said control MPO concentration.

2.  The method of claim 1, further comprising, prior to step a), centrifuging an anti-coagulated blood sample from said human subject to generate said plasma sample.

During prosecution of the application that issued as the '065 patent, the Examiner initially rejected the claims under 35 U.S.C. § 101 as being directed to an unpatentable abstract idea.  Cleveland Clinic overcame that rejection by citing Example 29 of the U.S. Patent and Trademark Office's "May 2016 Subject Matter Eligibility Update" (see "Subject Matter Eligibility Guidance — Example on Diagnosing and Treating Julitis" for our report on Example 29).  Example 29 sets forth seven claims directed to the detection of a hypothetical protein, JUL-1, and the diagnosis and/or treatment of a hypothetical autoimmune disease, julitis.  The first two claims of Example 29 recite:

1.  A method of detecting JUL-1 in a patient, said method comprising:
    a.  obtaining a plasma sample from a human patient; and
    b.  detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.

2.  A method of diagnosing julitis in a patient, said method comprising:
    a.  obtaining a plasma sample from a human patient;
    b.  detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; and
    c.  diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.

According to the example, claim 1 is considered to be patent eligible and claim 2 is considered to be patent ineligible.  The example explains that claim 1 is eligible because steps (a) and (b) of the claim "do not recite or describe any recognized exception."  As a result, the analysis of this claim ends with Step 2A of analytic framework set forth in the Interim Guidance (i.e., determining whether the claim is directed to a judicial exception), and the example notes that there is no need to proceed with Step 2B of the analytic framework (i.e., determining whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception).  With respect to claim 2, the example explains that:

[T]he claim recites diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected, which describes a correlation or relationship between the presence of JUL-1 in a patient's plasma and the presence of julitis in the patient.  This limitation sets forth a judicial exception, because this type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo).  Additionally, step c could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams).

In overcoming the § 101 rejection, Cleveland Clinic argued that the rejected claims more closely resembled claim 1 of Example 29 as opposed to exemplary claim 2 because the rejected claims were directed to a method of detecting myeloperoxidase rather than a method of diagnosing atherosclerotic cardiovascular disease.  The Examiner withdrew the rejection and the '065 patent proceeded to issuance.

As for the '597 patent, which was similarly rejected under § 101 as being directed to patent ineligible subject matter, Cleveland Clinic overcame the rejection by citing Example 29 and arguing that the claims amount to significantly more than the judicial exception.

Turning to True Health's Motion to Reconsider, Cleveland Clinic argued that the Federal Circuit's decision in Cleveland Clinic I did not control the outcome of the instant case because the '065 and '597 patents differ from the patents that were at issue in Cleveland Clinic I.  The District Court, however, indicated that "[a]lthough there are some differences among the various patents, they are not sufficiently distinct to render the Federal Circuit's decision irrelevant to the patents at issue."  Cleveland Clinic also argued that several steps in the claims of the '065 and '597 patents were not explicitly included in claims of the '552 patent.  With respect to this argument, the District Court determined that:

None of these additional steps explicitly appeared in the Cleveland Clinic I patents' claim language, and because the question of eligibility under § 101 turns on whether those steps are "conventional," . . . this Court must conduct an additional § 101 analysis incorporating those steps despite Cleveland Clinic I having affirmed the '552 patent's invalidity.

In analyzing the patent eligibility of the claims of the '065 and '597 patents under the two-step framework set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and Alice Corp. Pty. Ltd. v. CLS Bank lnt'l, 134 S. Ct. 2347 (2014), the District Court first explained that:

At the outset, there can be no dispute that the correlation between elevated MPO and [cardiovascular disease] is a natural law given that the Federal Circuit explicitly found as much in Cleveland Clinic I.  Accordingly, the issue before this Court is whether the '065 and '597 patents are directed to that natural law.  Plaintiffs' argument that these patents are not directed to a law of nature relies on the reasoning of the patent examiners, who found the analogy to USPTO Guidelines Example 29, Claim 1 persuasive.

With respect to Cleveland Clinic's argument that the '065 and '597 patents merely claim a laboratory method of "detecting" MPO activity, as opposed to a diagnostic method, and under Example 29 are therefore not directed to patent ineligible subject matter, the District Court responded that "Plaintiffs' argument is overly superficial," explaining that:

Although laboratory methods may be more likely to survive a § 101 inquiry, [] their survival is not automatic.  As defendant has aptly observed, the claims here contain qualifying language that distinguishes them from Example 29, Claim 1 and reveals that they remain directed to the natural law–that is, the correlation of [cardiovascular disease] to elevated MPO–rather than the laboratory method itself.  In particular, unlike the guidelines example, which was directed simply to a "method of detecting JUL-1," the claims in the '065 patent are directed to a "method of detecting elevated MPO mass in a patient sample . . . from a human patient having atherosclerotic [cardiovascular disease]," and the claims in the '597 patent are directed to a "method for identifying an elevated [MPO] concentration in a plasma sample from a human subject with atherosclerotic [cardiovascular disease]" (emphases added).  Given this language, the method is therefore only useful for detecting the elevated level of MPO linked to [cardiovascular disease]–that is, for detecting the natural phenomenon.  It is not a general laboratory technique for detecting MPO levels.  Because the method is directed at detecting the correlation that is the natural law, rather than MPO levels generally, it is clear that the method is directed to the natural law.  See Cleveland Clinic I, 859 F.3d at 1361 ([T]he method starts and ends with naturally occurring phenomena with no meaningful non-routine steps in between . . . .  The claims are therefore directed to a natural law.").  Accepting plaintiffs' argument to the contrary would permit artful drafters to recast any diagnostic patent as a laboratory method patent, frustrating the purpose of the natural law exception.  Accordingly, the USPTO's reliance on Example 29 was misplaced, and these claims are directed to the natural law that persons with [cardiovascular disease] have higher levels of MPO.

As for the step two of the Mayo/Alice analysis, the District Court concluded that "[c]onsidered independently and as an ordered combination, the additional steps in both the '065 and '597 patents are insufficiently inventive to save the claims."  With respect to the '065 patent, the Court noted that each of the steps of "obtaining a plasma sample"; "detecting . . . MPO mass . . . by contacting said plasma sample with anti-MPO antibodies and detecting binding"; and comparing the MPO level of the sample to "a control MPO mass level from the general population or apparently healthy subjects" was "well-understood, routine, conventional activity previously engaged in by scientists who work in the field" (quoting Mayo).  The District Court similarly determined that "[t]he steps added in the '597 patent, considered independently, also offer plaintiffs no assistance," adding that "none of the steps in the '597 patent are novel."

While acknowledging that "Plaintiffs' strongest argument is that the ordered combination of steps recited in these claims has not been previously used for this particular purpose" since "it is not well-understood, routine, or conventional to detect elevated MPO levels in plasma from a subject having atherosclerotic [cardiovascular disease]" (citing Cleveland Clinic's brief), the District Court stated that "the 'end result' of the claims in the '065 and '597 patents is the 'observation or detection' of the natural law."  The Court further declared that "Plaintiffs have offered no other use for these methods," adding that "[i]f merely using existing, conventional methods to observe a newly discovered natural phenomenon were enough to qualify for protection under § 101, the natural law exception would be eviscerated."

The District Court was unpersuaded by Cleveland Clinic's reliance on Viveve, Inc. v. Thermigen, LLC (E.D. Tex. 2017), observing that "[Viveve] only reinforces the conclusion that the '065 and '597 patents are directed to a patent-ineligible law of nature."  According to the Court, Viveve "recognized that the patent [asserted in that case] stood 'in stark contrast to those patents which the Federal Circuit has invalidated as directed to a natural law,' which 'typically encompass[ed] the pure observation or identification of the natural law at issue.'"  The Court explained that in contrast with Viveve, the '065 and '597 patents "are directed to 'pure observation or identification of the natural law at issue'–that [cardiovascular disease] generates higher MPO levels–and offer no additional inventive concept."  Noting that "[j]ust as a patent must do more than simply 'state the law of nature while adding the words 'apply it'' to claim eligible subject matter, . . . it must do more than simply state the law of nature while adding the words 'observe it,'" the District Court concluded that "[t]he plaintiffs here have not done so."  The Court therefore granted True Health's Motion to Reconsider and dismissed Counts 1 and 2 of Cleveland Clinic's complaint.

Cleveland Clinic Foundation v. True Health Diagnostics, LLC (E.D. Va. 2017)
Memorandum Opinion by District Judge Brinkema

By Kevin E. Noonan –

In the general chaos that has resulted from the Supreme Court's recent forays into trying to delineate the proper standards for patent subject matter eligibility (AMP v. Myriad Genetics, Mayo Collaborative Labs v. Prometheus), there is occasionally an inkling of the method behind this particular brand of jurisprudential madness.  That method, of course, is the Court's intuition that if it provides the broad contours of eligibility (as incoherent as they might be) the district courts and USPTO will provide the details that result in a reasonable standard.  (It is too much to hope for that the Court believes the Federal Circuit will provide much useful input in this regard, a determination that the appellate court has gone a long way to justify in decisions like In re BRCA1- and BRCA 2-based Hereditary Cancer Test Patent Litigation and Ariosa v. Sequenom.)  One example of that glimmer may be found in a decision by the District Court of Georgia affirming the advice of a special master that the District Court deny defendant's motion to dismiss based on failure to recite patent-eligible subject matter, in MiMedx Group, Inc. v. Liventa Bioscience, Inc.

The case arose in the context of patent litigation over U.S. Patent No. 8,709,494; claim 1 is representative:

1.  A dehydrated, laminated tissue graft consisting essentially of one or more washed and/or substantially cleaned amnion layers and one or more washed and/or substantially cleaned chorion layers, wherein at least one of the amnion layers contains its fibroblast cell layer, and further wherein the amnion layer and the chorion layer are directly laminated to each other.

The Court (District Court Judge Mark H. Cohen) appointed Sumner Rosenberg (Of Counsel, Mercer Thompson LLC) as a special master pursuant to Fed. R. Civ. P. 53.  The Special Master submitted a Report and Recommendations to Judge Cohen on a variety of issues, one of which was Liventa's Motion for Summary Judgment of Invalidity under 35 US.C. § 101 (and MiMedx's cross-motion for Summary Judgment that the claims of its patent-in-suit recited patent-eligible subject matter).  The Special Master recommended that the Court deny Liventa's motion and grant MiMedx's motion and the Court affirmed after de novo review, unpersuaded by Liventa's objections.  The Special Master concluded:

In the present case, merely separating the amnion from the chorion and using the amnion layer as a graft is analogous to the DNA gene [which the Court held was not patentable] in [Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013)] being separated from its surrounding genetic material.  On the other hand, the claimed tissue graft where the amnion and chorion layers are cleaned (i.e. having substantially all of the blood clots and the spongy/connective tissue removed) and laminated together absent such spongy/connective tissue [is] analogous to the cDNA [which the Court held was patentable] in Myriad.  The tissue grafts as claimed are indeed "something new" and that is sufficient to find they are not products of nature.

Liventa in its objections had argued that the Special Master erred in making his determination based on whether there was "something new" recited in the claim rather than that the claimed subject matter was "markedly different" from naturally occurring placental tissue.  Defendants analogized the invention to what was claimed by the patentee in Funk Bros. Seed Co. v. Kalo Inoculant Co. in support of this argument.  The District Court disagreed, finding that the Special Master had followed the Supreme Court's Mayo and Alice Corp. Pty. Ltd. v. CLS BCank Int'l decisions, using the Federal Circuit's two-part test as set forth in Rapid Litig. Mgmt. Ltd. v. CellzDirect. Inc.  Relevant to the eligibility standard, the District Court opined (in agreement with MiMedx) that "'[m]arkedly different' is far from a mandated standard of analysis" for making subject matter determinations under § 101.  This phrase came from the Supreme Court's Diamond v. Chakabarty decision as being "sufficient, but not [] necessary" for showing subject matter eligibility (emphasis in opinion).  Moreover, the District Court understood that this phrase from the Chakrabarty decision was never used again until it was quoted in the Myriad decision for distinguishing the Chakrabarty decision.  The Federal Circuit, for its part, has used the phrase only in its In re Roslin Institute (Edinburgh) decision, again using it as sufficient but not necessary condition for patent eligibility.  Significant to the District Court was the observation by the Special Master that "Myriad used the 'markedly different' language in finding a gene was not patentable, but used 'something new language'' in determining that another gene was patentable"(emphasis in opinion).  In this regard, the Court understood the term "something new" to mean, "not found in nature and not patent ineligible natural phenomena" rather than being merely novel.

It is unclear whether these distinctions will in all cases help clarify the proper standards for finding patent eligibility.  But it cannot be denied that focusing to any degree on novelty may help make the determination more objective, which could only help avoid the inherent subjectivity that has attended the application of the Supreme Court's subject matter eligibility standards both in the courts and the USPTO.

Order by District Judge Mark H. Cohen