Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)").  Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention.  On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc.  Over the next few weeks, Patent Docs will examine these amicus briefs. Here, we review the brief submitted by Amarantus Bioscience Holdings, Personalis, Inc., and Population Diagnostics, Inc.

In the brief's Statement of Interest, the amici state that they are companies that "discover and provide diagnostic tests that use exomes, genomes, and genetic biomarkers" and that their "ability [] to attract investment and to continue operations depends on ensuring that claims to such tests recite patentable subject matter."  From its website, Amarantus is "a publicly traded biotechnology company focused on developing therapeutic products with the potential for orphan drug designation in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, and diagnostics in neurology."  Personalis describes itself as a company that "provides researchers and clinicians accurate DNA sequencing and interpretation of human exomes and genomes" and that "support[s] researchers engaging in case-control, family-based, or proband-only genomic studies of disease, pharmacogenomics, and cancer."  The Population Diagnostics website characterizes the company's activities as "accelerating the delivery of personalized medicine diagnostic and therapeutic products to enable safe, low-cost, and more effective healthcare for patients."

The brief argues that the panel decision deprives the district courts and the U.S. Patent and Trademark Office of the guidance it should get from the Federal Circuit.  According to the brief, the Supreme Court has consistently held that claims must be considered as a whole, and that not doing so (which the brief contends was the flaw in the panel's decision) leads to "arbitrary and inconsistent results."  Specifically, the brief states that the Federal Circuit, as "the only Federal appeals court for patents" has an opportunity that it should not forego to provide "workable" guidance in properly applying § 101 of the Patent Act.  Such guidance should promulgate "a flexible, workable framework" within prevailing Supreme Court precedent, particularly under Mayo v. Prometheus and Alice v. CLS Bank.  And such guidance, according to these amici, rests on the principle that "claims be construed as a whole before validity is determined."

In this regard, the brief interprets the Supreme Court's language in setting forth the framework in the Alice case as requiring the "claims as a whole" analysis.  This standard finds support in the brief in language from Parker v. Flook and Diamond v. Diehr (an argument with some force, in view of the diametrically opposed precedential history of these cases).  The advantage of performing the Alice analysis based on the claims as a whole, according to these amici, is that it "produces a flexible, workable analysis that allows for fact-driven, nuanced decisions of patent-subject matter eligibility [by e]mploying ordinary claim construction."

Failure to perform the Alice analysis based on considering the claims as a whole, in contrast, results in a "lack of consistency" that the amici urge the Court to cure en banc.  The consequences of this lack of predictability harms "parties trying to obtain and defend good patents, harms parties trying to invalidate bad patents, and harms innovation in large technology sectors including personalized medicine, diagnostics, and software."  The brief mentions the relaxation of the standard of requiring claim construction as set forth in the Court's en banc decision in In re Bilski to a more recent panel decision eschewing this requirement in Bancorp Servs., L.L.C. v. Sun Life Assurance Co., 687 F.3d 1266, 1273 (Fed. Cir. 2012).  But "[u]ntethering claim validity from claim construction leaves the courts (and the USPTO) without any predictable constraints on how the determination will be conducted," the amici argue.  And as a consequence, the panel in this case (as well as the panel in the Bancorp case and perhaps others) have contravened the statute (35 U.S.C. § 112(b)) and prior precedent (In re Hiniker, 150 F.3d 1362, 1369 (Fed. Cir. 1998)) in adopting this relaxed standard of performing the § 101 analysis without considering the claims as a whole.

As a result, the amici argue, the courts and PTO have improperly applied the first step in the Alice framework, wherein rather than determining whether the claims are "directed to" a judicial exception to patent eligibility instead they have merely determined whether an exception is present in the claim.  This argument is supported by a quote from the panel decision in this case, where the amici argue the panel improperly applied the Alice test at least with regard to claim 25; specifically comparing:

[T]he asserted claims of the '540 patent are directed to a multistep method that starts with cffDNA . . . a naturally occurring non-cellular fetal DNA that circulates freely in the blood stream of a pregnant woman.  See, e.g., '540 patent claims 1, 24, 25. . . .  The method ends with paternally inherited cffDNA, which is also a natural phenomenon.  The method therefore begins and ends with a natural phenomenon.  Thus, the claims are directed to matter that is naturally occurring.  Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1376 (Fed. Cir. 2015).

with the claim language:

[M]ethod for performing a prenatal diagnosis on a maternal blood sample [comprising] . . . [A] obtaining a non-cellular fraction of the blood sample [B] amplifying a paternally inherited nucleic acid from the non-cellular fraction and [C] performing nucleic acid analysis on the amplified nucleic acid to detect paternablly inhereited fetal nucleic acid [italics in the brief].

From this the amici contend that "[c]learly, claim 25 includes in it numerous limitations, i.e., [A]-[C], that do not start and end with the same product," in support of their argument that the panel misapplied the Alice framework in arriving at its conclusion of patent ineligibility for Sequenom's claims.  The panel's misapplication of the test "opens a Pandora's box" because it "abstracts the claimed invention to a general concept in a way that is unprecedented for claim construction."

These amici further argue that the Federal Circuit has "addressed similar improper abstraction" in other areas of patent law and focused its analysis on the claims and specification.  In this section, the brief makes an analogy with how the Federal Circuit has applied the obviousness analysis in design patent law, where the Court has prohibited just the type of abstraction the amici find the panel employed in this case.  Here, in contrast, the brief asserts that the panel has succumbed to "excessive abstraction" in applying the analytical framework set forth in Alice with regard to the first prong of the analysis, and in doing so has rendered the second step a "foregone conclusion."

The amici then provide their views on the proper application of the patent eligibility analysis:

To avoid untethered abstraction, courts and the USPTO should consider: (i) the claims as a whole, (ii) in light of the specification, (iii) from the perspective of a skilled artisan, as well as (iv) the problem being solved by, (v) and the state of the art at the time of, the claimed invention.

The brief concludes with a discussion of the practical effects of this abstraction regarding the first step of the Alice test, wherein the search for the elusive "something more" in Justice Breyer's Mayo opinion permits courts and the PTO to dismiss affirmatively recited claim limitations as being "merely conventional" (as occurred in both the District Court and panel decisions in this case).  Here the brief contrasts the way the panel applied these steps in Sequenom's claims with how the panel (using the same framework) could have (or rather, would have) applied the Alice test to the claims in the Diehr opinion.  And as other amici have done, the consequence is that this panel would have declared the Diehr claims to be patent ineligible, in clear contradiction of the Supreme Court's decision that Diehr's claims recited patent-eligible subject matter.

These amici were represented by Maya Skubatch, Richard Torczon, Charles J. Andres, Jr. and Gideon A. Schor, Wilson Sonsini Goodrich & Rosati.

For additional information regarding this topic, please see:

• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Coalition for 21st Century Medicine," September 14, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: IPO," September 8, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Professors Lefstin and Menell," September 6, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: 23 Law Professors," September 3, 2015
• "Amici Support Sequenom's Petition for Rehearing En Banc," August 28, 2015
• "Sequenom Requests Rehearing En Banc," August 18, 2015
• "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015), June 22, 2015