EN | ES | DE | FR | IT | 日本語 | 한국어 | 中文

CAFC Upholds Unpatentability of Diagnostic Method Claims

What Questions Should Software Startups Ask Themselves? (VIDEO)
February 26, 2019
CAFC Affirms IPR Dismissal for Lack of Standing and Mootness
March 17, 2019

CAFC Upholds Unpatentability of Diagnostic Method Claims


By: Katie Rubino

On February 6th, 2019 the U.S. Court of Appeals for the Federal Circuit (CAFC) in Athena Diagnostics, Inc., v. Mayo Collaborative Services, held that diagnostic method claims were patent ineligible.

Athena Diagnostics is the exclusive licensee of the ‘820 patent, directed at methods for diagnosing neurological disorders, by detecting antibodies to a protein named muscle-specific tyrosine kinase (MuSK). The method covered by the ‘820 patent is particularly useful in diagnosing myasthenia gravis, a neurological disorders that can cause muscle weakness, drooping eyelids, double vision, and slurred speech. Myasthenia gravis is an autoimmune disease that causes a patient to produce antibodies against his or her own acetylcholine receptors. Some patients with myasthenia gravis do not produce antibodies to acetylcholine receptors but instead produce antibodies to MuSK. The method described in the ‘820 patent is useful for detecting the 20% of myasthenia gravis patients who produce the MuSK antibodies.

The District Court analyzed claims 7-9 of the ‘820 patent, applying the test for subject matter eligibility established by the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc. In Mayo v. Prometheus, the Supreme Court unanimously found that claims directed to a method of giving a drug to a patient and measuring the metabolites of that drug to then adjust a patient’s dose, was not patent eligible subject matter. The Supreme Court held that the correlation between drug metabolites and dose adjustments were directed towards “natural laws.” The Supreme Court further reasoned that a law of nature is itself unpatentable, and the application of a law of nature is unpatentable if the application relies upon elements already known in the art.

In Athena v. Mayo, the District Court concluded that the claims in the ‘820 were directed towards a law of nature. On appeal, the CAFC affirmed, reasoning that “claiming a natural cause of an ailment and well-known means of observing it is not eligible for patent because such a claim in effect only encompasses the natural law itself. But claiming a new treatment for an ailment, albeit using a natural law, is not claiming the natural law.”

The CAFC then turned to the rationale set forth in Alice Corp. v. CLS Bank International to examine whether the elements of each claim both individually and as an ordered combination transform the claims into patent-eligible subject matter. Athena argued that the claims provide an inventive step that includes man-made molecules. Athena pointed out that the method described in the ‘820 patent was the first one to detect MuSK antibodies. Mayo argued that the method steps described in the ‘820 patent were commonly known in the art.

The CAFC considered all arguments and affirmed the ruling of the District Court, finding that claims 6-9 of the ‘820 patent are patent ineligible under ⸹101. This case is significant in that the majority and the corresponding dissenting opinion highlight the split opinion among the justices in this area. While the majority opinion upheld and applied prior cases decided at the Supreme Court, the dissenting opinion highlighted the hamper this decision places on innovation in the chemical arts field. Judge Newman declared that “the public interest is poorly served by adding disincentive to the development of new diagnostic methods.” Going forward, it will be interesting to see if further cases provide subsequent developments in this area.

Ask a Question


  1. I really love your site.. Pleasant colors & theme.

    Did you build this web site yourself? Please reply back as I’m
    hoping to create my own personal website and would like to learn where you got this from or what the theme is named.

  2. Appreciate this post. Let me try it out.

  3. Thanks , I have just been searching for information about this subject for a long time and yours is the greatest I’ve discovered
    so far. However, what in regards to the bottom line?
    Are you sure in regards to the source?

  4. I’m not sure why but this site is loading extremely slow for me.
    Is anyone else having this problem or is it a issue on my end?
    I’ll check back later and see if the problem still exists.

  5. What’s up, this weekend is good in support of me, because
    this occasion i am reading this fantastic informative piece of writing here at my home.

  6. We are a group of volunteers and opening a brand new scheme
    in our community. Your web site provided us with useful information to work on. You have done an impressive task and our whole neighborhood can be
    thankful to you.

  7. After looking over a number of the blog articles on your blog, I truly appreciate your way of blogging.

    I saved it to my bookmark webpage list and will be checking back soon. Take a look at my website too and
    tell me what you think.

  8. As the admin of this website is working,
    no doubt very soon it will be famous, due to its quality contents.

  9. Hi there this is kind of of off topic but I was wanting to know if blogs use WYSIWYG editors
    or if you have to manually code with HTML. I’m starting a blog soon but have no coding knowledge so I wanted to get guidance from someone with experience.
    Any help would be enormously appreciated!

  10. I could not refrain from commenting. Perfectly written!

  11. My spouse and I absolutely love your blog and find a
    lot of your post’s to be just what I’m looking for. Would you offer guest writers to write content available for you?

    I wouldn’t mind producing a post or elaborating on some of the
    subjects you write about here. Again, awesome weblog!

  12. If some one wants to be updated with most up-to-date technologies after that he must be go to see this web page and
    be up to date every day.

  13. It’s difficult to find knowledgeable people on this subject, but you
    seem like you know what you’re talking about!


  14. Hey there, You have done an excellent job.

    I will definitely digg it and personally suggest to my friends.
    I am confident they will be benefited from this website.

  15. Pretty nice post. I just stumbled upon your weblog and wanted to say
    that I’ve really enjoyed browsing your blog posts.
    After all I will be subscribing to your feed and I hope you write again very soon!

  16. Post writing is also a fun, if you be acquainted with then you can write if not it
    is complicated to write.

  17. Today, I went to the beach front with my kids.
    I found a sea shell and gave it to my 4 year old daughter and said “You can hear the ocean if you put this to your ear.” She put the shell
    to her ear and screamed. There was a hermit crab inside and it pinched her ear.

    She never wants to go back! LoL I know this is completely off topic but I had to tell someone!

  18. I am not sure where you are getting your information, but good
    topic. I needs to spend some time learning much more or understanding more.

    Thanks for excellent info I was looking for this info for my

  19. hey there and thank you for your info – I’ve certainly picked up
    something new from right here. I did however expertise several technical
    points using this website, as I experienced to reload
    the web site a lot of times previous to I could get it to load properly.

    I had been wondering if your web host is OK?
    Not that I’m complaining, but sluggish loading
    instances times will often affect your placement in google and could damage
    your quality score if ads and marketing with Adwords.
    Well I am adding this RSS to my email and can look out for much
    more of your respective intriguing content. Ensure that you update this again soon.

  20. We are a group of volunteers and opening a new scheme in our community.
    Your site provided us with valuable information to work on. You have done an impressive job
    and our whole community will be grateful to you.

  21. quest bars says:

    Marvelous, what a web site it is! This website presents valuable facts to us, keep it up.

  22. Thank you for the auspicious writeup. It in fact was a amusement account it.
    Look advanced to far added agreeable from you!
    By the way, how could we communicate?

  23. tinyurl.com says:

    you are really a just right webmaster. The site loading
    pace is amazing. It sort of feels that you’re doing any unique
    trick. Furthermore, The contents are masterwork.
    you’ve performed a fantastic task in this matter!

Leave a Reply

Your email address will not be published.