Alice/Mayo Athena Diagnostics Books CAFC Courts diagnostic methods District Courts Federal Circuit Guest Contributor Guest Contributors Inc. v. Mayo Collaborative Servs. IP News IPWatchdog Articles Judge Pauline Newman Litigation llc Mayo v. Prometheus patent patent eligibility patent eligible Patent Litigation Patentability Patents Section 101 Technology & Innovation

CAFC Affirms Athena’s Diagnostic Method Claims Patent Ineligible Under Section 101

Federal Circuit

The place the claims recite solely typical steps for locating a pure regulation with out significant non-routine steps in between, the claims are patent-ineligible underneath Part 101. The place the recited steps apply typical methods to detect a pure regulation, it’s irrelevant that the steps are recited with specificity.

As mentioned in short right here, the Federal Circuit lately issued an opinion affirming the choice of america District Courtroom for the District of Massachusetts, which held that Athena’s medical diagnostic strategies have been directed towards legal guidelines of nature and patent ineligible underneath 35 U.S.C. § 101. Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, No. 17-2508, 2019 U.S. App. LEXIS 3645 (Fed Cir. Feb. 6, 2019) (Earlier than Newman, Lourie, and Stoll, Circuit Judges) (Opinion for the Courtroom, Lourie, Circuit Decide) (Dissenting Opinion, Newman, Circuit Decide).

The inventors of U.S. Patent 7,267,820 (the 820 Patent) found that about 20% of sufferers with the neurological dysfunction myasthenia gravis (MG) generate autoantibodies to a membrane protein referred to as MuSK. Till their discovery, no illness had ever been related to the protein. The ‘820 patent disclosed and claimed strategies for diagnosing neurological issues by detecting antibodies that bind to MuSK.

Athena Diagnostics (Athena), the ‘820 Patent’s unique licensee, sued Mayo Collaborative Providers (Mayo) for infringement. Mayo moved to dismiss, and the district courtroom granted Mayo’s movement, concluding that the patent claimed ineligible material and was invalid beneath 35 U.S.C. § 101. Athena appealed, and the Federal Circuit affirmed. 

The asserted claims recite steps to detect autoantibodies that bind to MuSK. Declare 1, which isn’t at situation within the case, recites:

  1. A way for diagnosing neurotransmission or developmental issues associated to muscle particular tyrosine kinase (MuSK) in a mammal comprising the step of detecting in a bodily fluid of stated mammal autoantibodies to an epitope of muscle particular tyrosine kinase (MuSK).

Declare 7, one of many claims at situation, additional recites:

  1. A way in line with declare 1, comprising contacting MuSK or an epitope or antigenic determinant thereof having an appropriate label thereon, with stated bodily fluid, immunoprecipitating any antibody/MuSK complicated or antibody/MuSK epitope or antigenic determinant complicated from stated bodily fluid and monitoring for stated label on any of stated antibody/MuSK complicated or antibody/MuSK epitope or antigen determinant complicated, whereby the presence of stated label is indicative of stated mammal is affected by stated neurotransmission or developmental dysfunction associated to muscle particular tyrosine kinase (MuSK).

Declare eight relies upon from declare 7 and recites that the label is a radioactive label. Declare 9 additional relies upon from declare eight and requires “1) contacting MuSK or an epitope thereof having a 125I

label, with bodily fluid; (2) immunoprecipitating any antibody/MuSK complicated; and (three) monitoring for the label on the complicated, whereby the presence of the label signifies the

presence of a MuSK-related dysfunction.” The specification of the ‘820 Patent explains what iodination and immunoprecipitation entail and particularly discloses that “[i]odination and immunoprecipitation are normal methods within the artwork.”

Making use of Mayo/Alice

The Courtroom utilized the two-part check set forth by the Supreme Courtroom in Mayo v. Prometheus and Alice Corp. v. CLS Financial institution, analyzing: (1) whether or not the claims are “directed to” a regulation of nature, and, in that case, (2) “whether or not the restrictions of the declare aside from the regulation of nature, thought-about individually and as an ordered mixture, rework the character of the declare right into a patent-eligible software.”

Relating to the primary prong of the check, the Courtroom addressed whether or not the claims have been directed to a regulation of nature. To find out whether or not the declare is directed to an ineligible idea, the Courtroom thought-about “whether or not the claimed advance improves upon a technological course of or merely an ineligible idea.” Thus, the place “

The Courtroom finally discovered the claims have been directed to a regulation of nature, particularly the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological illnesses. The Courtroom reasoned that the claims recited solely the invention of a pure regulation along with concrete, normal steps for observing its operation. The specification itself described the invention as the invention of a pure regulation and described the claimed steps for observing the pure regulation as typical. The extra recited steps utilized typical methods to detect the pure regulation – that they have been described with specificity was irrelevant.

Relating to the second prong, the Courtroom discovered the claims lacked an creative idea adequate to rework a regulation of nature right into a patent-eligible software of the regulation. As step two of the Mayo/Alice check, the Courtroom thought-about “the weather of every declare each individually and as an ordered mixture to find out whether or not the extra parts rework the character of the declare right into a patent-eligible software.” Right here, the specification outlined the person immunoprecipitation and iodination steps and the general radioimmunoassay recited within the claims as typical methods. As a result of the recited steps solely required normal methods to be utilized in an ordinary approach, the claims failed to offer an creative idea.

For these causes, the bulk upheld the district courtroom’s discovering of invalidity.

Newman Dissents

Decide Newman issued a dissenting opinion. There, she said that, thought-about as an entire, the claims weren’t directed to a regulation of nature however moderately to a multi-step technique of diagnosing neurological issues by detecting autoantibodies utilizing a collection of chemical and organic steps. Based on Decide Newman, the bulk ignored particular claimed steps by which the analysis is carried out and thereby improperly discarded declare limitations and failed to think about every declare as an entire.

Decide Newman additionally identified that, previous to the invention of the diagnostic technique, 20% of sufferers affected by MG weren’t able to being recognized. The inventors utilized their discovery of the autoantibodies that bind to MuSK to create a brand new technique of diagnosing a situation that was earlier undiagnosable. Quite than “claiming the scientific reality of a newly described autoantibody[,] they’re claiming a brand new multi-step diagnostic technique.”  Based on Decide Newman, “


Robert Schaffer & Joseph Robinson

Robert Schaffer & Joseph Robinson


Robert Schaffer is an mental property associate at Troutman Sanders. Bob applies greater than 30 years of expertise to IP counseling and litigation. His work consists of patent procurement, strategic planning and transactional recommendation, due diligence investigations, district courtroom patent instances, and Federal Circuit appeals. He commonly handles complicated and high-profile home and worldwide patent portfolios, mental property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed courtroom instances Bob’s work consists of representing and counseling shopper in ANDA litigations, complicated patent infringement instances and appeals, and multidistrict and worldwide instances. In disputed Patent Workplace issues his work consists of representing and counseling shoppers in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For extra info and to contact Bob please go to his profile web page on the Troutman Sanders web site.

Joseph Robinson has over 20 years of expertise in all elements of mental property regulation. He focuses his follow within the pharmaceutical, life sciences, biotechnology, and medical gadget fields. His follow encompasses litigation, together with Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in quite a lot of patent and trademark disputes in many various jurisdictions, and has additionally served as appellate counsel earlier than the Courtroom of Appeals for the Federal Circuit. Joe additionally focuses on complicated inter partes issues earlier than the united statesPatent and Trademark Workplace, inventorship disputes, reexaminations and reissues. His expertise consists of quite a few interferences, a specific benefit in new U.S. Patent and Trademark Workplace post-grant proceedings. He additionally counsels on patent–associated U.S. Meals and Drug Administration points, together with citizen petitions, Orange Guide itemizing, and trademark points. For extra info and to contact Joe please go to his profile web page on the Troutman Sanders web site.

Robert Schaffer & Joseph Robinson

Dustin Weeks

is a Companion within the mental property follow group at Troutman Sanders. His apply spans all areas of mental property regulation, together with patent prosecution, patent litigation (together with Hatch-Waxman litigation), and shopper counseling. He represents shoppers starting from start-ups and solo inventors to Fortune 500 corporations. Dustin works intently together with his shoppers to study their enterprise goals in order that he can tailor methods to acquire, shield, and implement their mental property. Dustin focuses on post-grant proceedings (e.g. Inter Partes Evaluations) earlier than the Patent Trial and Attraction Board (PTAB) the place he has in depth expertise representing each patent house owners and petitioners throughout a variety of applied sciences, together with wi-fi networking, prescription drugs, MEMs units, medical units, and electro-mechanical shopper units. Dustin’s broad expertise in patent prosecution, counseling, and patent litigation uniquely positions him to navigate the blended apply of post-grant proceedings.

For extra info or to contact Dustin, please go to his Agency Profile Web page.

About the author