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
It is instructive to study the file of EP 2718773 which is equivalent to US 7223552.
The European application was subjected to searching examination with much cited prior art, going so far as a summons to oral proceedings. The applicant avoided the need for a hearing by a response filed in August 2012, the crucial part of which reads: "There is no suggestion in D9, which describes measurement of MPO activity in frozen homogenized myocardial tissue, that a blood sample can be removed from a human patient and tested for levels of a circulating marker, i.e. MPO activity or mass, and a characterization of the risk of having or developing CVD being made therefrom." Those of us on this side of the Pond would take the view that this says it all.
If we take the claim of the 065 patent:
(a) the hand of man takes a plasma sample from a human patient having CVD;
(b) the hand of man contacts the plasma sample with anti-MPO antibodies, this being an in vitro technical process, not something occurring in nature and being of a transformative nature since a binding product is produced in vitro; and
(c) the hand of man carries out the further in vitro technical process of detecting the binding product, that detection permitting evaluation of whether there is elevated MPO mass.
On any reasonable view, this sequence of steps falls as a matter of substance and not mere appearance within the "process" category of Section 101. On judicial exceptions, the claimed subject matter is not directed to laws of nature but to laboratory operations conducted in test tubes with reagents. If the Memorandum Opinion had been submitted as an extended piece of work in response to a question at Bournemouth University, a failing grade would probably have been appropriate.
Posted by: Paul Cole | August 18, 2017 at 02:21 AM
Mr. Cole,
By now I had hoped that you would have realized that what the Supreme Court (and merely being applied by the lower courts here) did was provide a weapon that removes the statutory categories from primary consideration.
We really do have a case where exceptions HAVE swallowed the rule.
It was the Supreme Court though that did this.
It was the Supreme Court that (indirect contradiction to the Act of 1952), reached back and reinstalled their "Gist of the invention" mantra that Congress had removed when Congress removed the power of common law development of "invention," "gist of the invention," or other of more than a dozen like phrases and IN THEIR PLACE chose a different path - that of 35 USC 103.
Architects of this change have spoken out (nigh 50 plus years ago) and have, in their time, battled our Supreme Court, who apparently feels compelled to answer to no one.
There indeed is a failing grade to be had here.
But that failing grade goes to our Supreme Court first and foremost.
Posted by: Skeptical | August 18, 2017 at 09:42 AM
@ Skeptical
Are you sure that it was the Supreme Court that did this, and not the lower courts, the USPTO and members of our profession through judicial cringe?
Where is the authority in ANY Supreme Court opinion that the standard procedure should be to ignore the affirmative provisions of Section 101, and instead to consider only the judicial exceptions? Have a look at the section entitled "8 Omitted-Case Canon" at page 93 of Scalia and Garner's book Reading Law (and remember with sorrow the passing of Antonin Scalia). Quoting briefly from their first paragraph: "Nor should the judge elaborate unprovided-for exceptions to a text, as Justice Blackburn noted while a circuit judge: 'If the Congress had intended to provide additional exceptions, it would have done so in clear language'" In Diamond v Chakrabarty, Justice Berger quoted United States v. Dubilier Condenser Corp.,289 U. S. 178, 289 U. S. 199 (1933)that courts ""should not read into the patent laws limitations and conditions which the legislature has not expressed." The judicial exceptions of laws of nature, abstract ideas and natural phenomena form a set of exclusions that does not and should not intersect with the set of four eligible categories. The duty of our profession is to remind the lower courts and the USPTO of this fact FIRMLY, CLEARLY and OFTEN with explicit reference to authority.
And as in my Recognicorp brief, where is the authority that the words "directed to" permit rewriting of a patent claim in violation of the "all elements" rule?
As has arisen in a completely different context, Jesus did not pray for a continuous 50-year supply of food. He did not even pray for food to the end of the year. His prayer was for the here and now: "Give us each day our daily bread." Equally in our profession though we might campaign for a new case to go to the Supreme Court or for Congress to amend Section 101, we have to practice our profession and represent our clients each day. All that we can do is to ensure that our claims clearly fall as a matter of substance and not mere outward appearance within one of the four eligible categories, and in court to argue clearly and fully for eligibility demanding that both positive compliance and judicial exceptions should be considered.
Posted by: Paul Cole | August 18, 2017 at 12:38 PM
To directly answer your question, "Are you sure that it was the Supreme Court that did this"
Yes.
Follow Justice Stevens along the arc of the eligibility cases (as well as his mentor and his protegee). Then follow those that joined him in the Bilski dissent dressed as a concurrence.
The Court (notably the current Court as opposed to your reference to past historical icons) has fractured and its views are not reconcilable with itself.
Posted by: skeptical | August 19, 2017 at 07:11 AM
@ Skeptical
I suspect that we are both right, but in different ways.
Posted by: Paul Cole | August 19, 2017 at 03:44 PM
Mr. Cole,
Call me skeptical (naturally), but the ways in which we are both right are not equal. I believe that you may be right in a "this is how it should be based on academics" model, while I am right based on "this is how it is in the real world because the Supreme Court DOES act as if it is above the Constitution, and legislates on statutory law from the bench."
Your snippets then of past Supreme Court lucidity, simply fall away in the aggregate view of what the Court has actually done - and the mess that the Court has created in US patent law.
The sad thing of course is that ALL of the proposed changes to Congress to undo the recent spate of eligibility decisions of the Court are in vain, unless the Congress exercises its own Constitutional power of jurisdiction stripping and removing the Supreme Court from the non-original jurisdiction of patent appeals.
Granted, an Article III court must still be involved (to preserve the holding of Judicial Review from the Marbury** case), and granted that the current CAFC is not a worthy vessel for such a responsibility, given how brow-beaten that entity has become; so a new dedicated Article III patent court should accompany any application of jurisdiction stripping.
That's a tall order for a legislature that is by and large captured (or at the least, overly influenced by the voices traceable to the merely juristic persons of corporations, such voices unduly amplified by our Citizens United case).
So the chances of a true and deep correction are not great.
** As a scholar, I am sure that you can appreciate that the judicial review holding of Marbury NOWHERE indicates that such review must be with the Supremes themselves, and that any view of the Supremes towards non-original jurisdiction stripping cannot rewrite that Constitutional power merely to enable the Court to keep its fingers in the wax nose of 101.
Posted by: skeptical | August 20, 2017 at 08:13 AM