Athena Implores Supreme Court to Heed Federal Circuit’s ‘Unprecedented Cry for Help’

By IPWatchdog
October 3, 2019

“In the month after Mayo was decided, the PTO rejected 32% of the patent applications for medical diagnostics, up from 7% before…. Everyone loses as a result.” – Athena petition for certiorari

As expected, Athena Diagnostics last night filed its petition for certiorari to the U.S. Supreme Court, asking it to fix the United States’ patent eligibility law problem. Adam Gahtan and Eric Majchrzak of Fenwick & West and Seth Waxman, Thomas Saunders, Joshua Koppel and Claire Chung of WilmerHale filed the petition for Athena.

The specific question Athena is presenting is:

Whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter, where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.

Athena urged the Court to take the case considering the Federal Circuit’s eight separate opinions in which the court divided 7-5 on denying en banc review—evidence of “much-needed guidance on the proper application of the judicially-created exceptions to Section 101 of the Patent Act.”

The Federal Circuit in July issued an 86-page order comprising eight separate opinions. Throughout the opinions, it seemed clear that the Federal Circuit was eager to have the Supreme Court take the case up on appeal in order to clarify Mayo’s judicial exception to laws of nature and its impact on patent claims covering medical diagnostics.

In the petition, Athena warned the Supreme Court that failure to clarify the law in favor of finding claims like the ones at issue in the case patent eligible will be a death-knell for medical diagnostics. The petition said:

If these claims do not even meet the threshold requirement of being the kind of subject matter eligible for patent protection, that is the end of patent eligibility for the overwhelming majority of medical diagnostic methods—leading to profound consequences for future investment in scientific research and public health.

The petition identifies for the Court five points of confusion that have emerged over the Court’s precedent in this area. They are:

  • Courts have struggled with the tension between the Federal Circuit’s striking down a diagnostic method claim that uses novel man-made molecules and this Court’s holding that a “molecule that is not naturally occurring” is “not a ‘product of nature’ and is patent eligible under § 101.”
  • Courts have struggled to apply the principles articulated in the context of the unusual facts of Mayo to more typical patent claims.
  • Courts have struggled with the level of abstraction at which to determine whether the steps of a claim “transform an unpatentable law of nature into a patent eligible application of such a law.”
  • The Federal Circuit’s approach gives little consideration to the “preemptive” scope of a claim, contrary to this Court’s guidance.
  • Courts have struggled with what it means to review a claim “as a whole.”

Athena also cited broad agreement among prominent members of the patent bar on the need for clarity. Retired Federal Circuit Chief Judge Paul Michel, current and former directors of the USPTO, practitioners, the American Bar Association, and patent scholars, have all decried the state of the law, said the petition.

Perhaps most importantly, the chaos threatens to disrupt crucial medical innovation, wrote Athena. The petition explained:

“Since Mayo, the Federal Circuit “ha[s] held every single diagnostic claim in every case before [it] ineligible” for patent protection…. This rule will have devastating consequences. In the month after Mayo was decided, the PTO rejected 32% of the patent applications for medical diagnostics, up from 7% before. Chien & Wu, Decoding Patentable Subject Matter, 2018 Patently-O Pat. L.J. 1, 15 (Oct. 21, 2018), https://bit.ly/2oBO1i5. By the time Alice was decided, that rejection rate had climbed to more than 50%, and at one point hit a high of 64%. Id. With the decision below, that rate will climb significantly higher—if inventors even bother to apply for patents for diagnostic methods at all.

Everyone loses as a result. “Diagnostics are an essential category of medical technologies, critical to treating illnesses and saving lives.”

Athena also argues that the specific claims at issue in the case are particularly well-suited to clarify the law, since they are a far cry from the “’methods of entering into contracts, or horse whispering, or speed dating or other methods’ that have animated this Court’s concerns regarding Section 101,” said Athena. In particular, the claims:

  • use novel man-made molecules; and
  • recite specific chemical steps to achieve a new and useful result.

Athena further noted that the Federal Circuit’s rules used to invalidate medical diagnostic claims find no support in the statute. Since the Supreme Court created the problem, it is up to them to fix it, the petition concluded:

“This Court, as the creator of those non-textual exceptions, bears a special responsibility to ensure that they are properly interpreted and applied. The Court has admonished courts to “tread carefully” lest the exceptions “swallow all of patent law.” Alice, 573 U.S. at 217. But the Federal Circuit has not heeded that admonition, allowing those exceptions to expand ever outward and swallow the field of medical diagnostics. The legal issues are too fundamental, and the stakes too high, to allow that misapplication of the law to stand.”

Considering the stakes, it would be shocking if the High Court decides not to grant cert.

Stay tuned for reaction from the bar.

The Author

IPWatchdog

IPWatchdog

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Discuss this

There are currently 28 Comments comments. Join the discussion.

  1. Concerned October 3, 2019 11:32 am

    Many of these Athena points are similar to Trading Tech’s points regarding the question:

    Does a computer process have to improve the computer itself regardless of the problem being solved?

    I would like the high court to accept both Athena and Trading Techs certs. Let the inventors know exactly where we stand and be clear about it for better or for worse.

    Are we to be swallowed by all of patent law and go home? Or are we serious about solving real problems that have been acknowledged by patent examiners?

    Are we more concerned about the “how” or more concerned by the “what?”

    Those are fair questions.

  2. Anon October 3, 2019 12:45 pm

    While the desire for the Court to take this case may be high, the likelihood simply is not high.

    The Court would have to admit that it has mucked things up.

    Does anyone really think that THAT will happen.

    (Or course, for the Curious who may spend less than a minute googling, the Court does have its new fangled tool for cutting thought Gordian Knots: the Kavanaugh Scissors 😉 )

  3. B October 3, 2019 3:50 pm

    I’m reading American Axle. The pathology is worse than anyone thought. http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-1763.Opinion.10-3-2019.pdf

    I called this near 100%.

    Judge Moore dissents stating: “The majority opinion parrots the Alice/Mayo two-part test, but reduces it to a single inquiry: If the claims are directed to a law of nature (even if the court cannot articulate the precise law of nature) then the claims are ineligible and all evidence of non-conventionality will be disregarded or just plain ignored.
    .
    .
    .
    I am deeply troubled by the majority’s disregard for the second part of the Alice/Mayo test, its fact finding on appeal and its repeated misrepresentation of the record, in each instance to the patentee’s detriment; all when we are to be applying the summary judgment standard no less” (emphasis added).

    And the CAFC lying about the factual record is new . . . how?

  4. Anon October 3, 2019 3:58 pm

    Speaking about cries for help, and only slightly OT, but should we be making a “wellness call” to Bud, since the American Axle Case came out today (and very much to his stated dread)…?

  5. B October 3, 2019 5:22 pm

    At anon “Speaking about cries for help, and only slightly OT, but should we be making a “wellness call” to Bud, since the American Axle Case came out today (and very much to his stated dread)…?”

    I did call that one. However, to my delight Judge Moore basically calls Taranto and Dyk liars.

    Anyway, it took a good five months to put that much fiction to paper

  6. Anon October 3, 2019 6:30 pm

    I have to wonder if Congress is awake or aware of these transpirings….

    (and let me plug again: jurisdiction stripping and NEW Article III patent court reformulation)

  7. Pro Say October 3, 2019 8:00 pm

    . . . and America is choking on the patent law that the CAFC has swallowed.

    Hear that? That’s the Chinese and Europeans hooping and howlering from across the oceans.

    Loving it that our very own courts are destroying American innovation.

    I’ve said it before and I’ll say it again:

    The year is 2030.

    Welcome to Chinamerica.

    Congress: Where. Are. You?

  8. Bemused October 3, 2019 8:29 pm

    Anon@2: Have to agree with you there, friend. Clearly, the black-robed egomaniacs on SCOTUS (most of them, anyway) feel it beneath their dignity to have to clarify to us mere mortals and to the lower courts the meaning of their nonsensical, vague and blurred lines patent tests that they’ve articulated and which have all lead to the sinking of the U.S.S. Patent System.

    I read the petition and its generally well-written (not surprising given the legal firepower representing Athena) but I would rate the chances of a cert grant as slim to none.

    Hopefully, I’ll be proven wrong.

  9. Concerned October 3, 2019 9:46 pm

    The patent examiner disregarded the second part of Alice on my application as well. His argument was if it is abstract it cannot be a new and useful process or practical application.

    Sad.

  10. TFCFM October 4, 2019 11:46 am

    The specific question Athena is presenting is:
    Whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter, where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.

    This case, it seems to me, is a good opportunity for the Supreme Court to clarify at least PART of what I believe it is trying to convey about patent eligibility.

    As background, it’s important to understand some aspects of the technology at issue. In a nutshell, the patentee discovered that when disease “D” occurs, a molecule “M” occurs in the human experiencing the disease. Although the patentee was the first to realize the association “M means D,” the association has presumably existed as long as the disease has (that is, M has *always* meant D, regardless of whether one realized it).

    M is a type of molecule that is utterly routine to detect. There was nothing remotely inventive about the reagents or methods used to detect M. If you had told any skilled artisan to detect M, it would have been immediately obvious that the claimed methods/reagents would be good methods/reagents to detect M.

    Here, the patentee claimed a method of diagnosing D by detecting M in a patient. The patentee claimed detecting M (by any method in non-asserted claim 1, or by a particular method in asserted claim 7) and diagnosing D if M is detected.

    The district court and the Federal Circuit panel that reviewed it both held that claim 7 is directed to a “law of nature” and therefore ineligible. Declining to rehear the appeal en banc, the judges were all over the place — generally concurring that new diagnostic methods are a good thing and appropriately rewarded with patents but, in my opinion, failing to look close enough at whether the claimed methods are, in fact, new diagnostic methods. I think the claims here require a closer look.

    Claim 1 (remember, not asserted) seems to be the paradigm of an abstract idea. It recites, essentially, “detect M by any means (whether or not yet invented) and diagnose D if you detect it.” That is, as the courts held, a patent directed squarely (and solely) to the law of nature (“M means D”), because it would preempt all practical applications of the natural law. This seems to me an entirely appropriate use of “abstract-idea-analysis”: to prevent someone from claiming all possible ways of achieving a desirable end, when the inventor(s)’ only contributions are ineligible “mere ideas.”

    A different analysis applies to claim 7, IMO.

    Asserted claim 7 recites, essentially, “detect M by a particular method and diagnose D if you detect it.” Applying Alice/May, a court reasoned that claim 7 is merely claim 1 (abstract idea) + “something more,” the “something more” being the particular method for detecting M. The problem with applying Alice/May is that although the particular method may be a “routine and conventional” way of detecting molecules like M, nobody (apparently) routinely or conveniently used that method to *actually* detect M or in a method for diagnosing D, so there appears to be a “piece missing” from the ineligibility analysis. (This is what I find disturbing about some ineligibility decisions post-Alice.)

    Claim 7 clearly doesn’t preempt an abstract idea, and there’s no good reason to think that the particular M-detection method was “routine or conventional” in the claimed context, so it seems to me that claim 7 should be considered not-ineligible. However, claim 7 should fall when analyzed for obviousness. Claim 7 consists of a set of discrete physical steps, combined with two closely-related mental steps. (Mental steps are not, of course, entitled to patentable weight in anticipation or obviousness analyses). That is, claim 7 effectively instructs:
    – think to assess M (because we now know that “M means D”)
    – perform the sequence of physical steps to detect M and
    – if the methods detect M, then think that D is present (because “M means D”).

    Stripped of the two mental steps, analysis of the claimed physical steps reduces to comparison of those steps with the prior art, yielding a determination that claim 7 is either anticipated (if someone previously performed the steps on M specifically) or obvious (if others performed the steps on molecules like M, which is certainly true here).

    Therefore, in my mind, the more correct outcome here (even on a motion for summary judgment, given the uncontested ‘old’ nature of the physical steps) is that claim 7 (at least) is invalid as obvious, rather than ineligible. Had claim 1 been asserted, it would correctly have be held ineligible.

    This case seems to me a good vehicle for the Supreme Court to use to distinguish between

    A) situations in which abstract-idea-analysis should be used to inform eligibility (i.e., claims which preempt all applications of an idea) and

    B) situations in which abstract-idea-analysis should be used to frame traditional anticipation/obviousness analysis (i.e., discounting mental steps, claimed method is anticipated/obviousness).

    Had the patentees invented some new and non-obvious way of detecting M, that inventions ought to have been patentable, regardless of whether the method was claimed as a standalone M-detection-method or it was claimed in the context of diagnosing D.

  11. B October 4, 2019 1:38 pm

    @ TCFCFM “This case seems to me a good vehicle for the Supreme Court to use to distinguish between A) situations in which abstract-idea-analysis should be used to inform eligibility (i.e., claims which preempt all applications of an idea) and B) situations in which abstract-idea-analysis should be used to frame traditional anticipation/obviousness analysis (i.e., discounting mental steps, claimed method is anticipated/obviousness).”

    Wow, as if the previous 46 cert petitions didn’t address this very same issue.

    Seriously, you’re so slow I suspect that you’re thinking in reverse.

  12. TFCFM October 5, 2019 10:45 am

    That’s possible.

    Another possibility is that one of us is able to perceive differences among these various cases.

  13. Anon October 5, 2019 6:28 pm

    TFCFM,

    That you think yourself to be the perceptive one is more than just a little disturbing.

  14. B October 5, 2019 10:16 pm

    @ TFCFM “Another possibility is that one of us is able to perceive differences among these various cases.”

    *eye roll*

    Please, tell me the difference Why Trading Technologies v. IBG turned out different from Trading Technologies v. CQG.

    In both cases the claims were directed to new, useful, unanticipated, and nonobvious GUIs, yet one set of claims were held patent ineligible.

  15. TFCFM October 6, 2019 11:12 am

    B: “Please, tell me the difference Why Trading Technologies v. IBG turned out different from Trading Technologies v. CQG.

    This post, and my comment about it, concern the Athena D v. Mayo decision. Should someone write a comment comparing those two decisions, I’ll be happy to comment there, should I have something relevant to say about the cases or the comparison.

  16. Anon October 6, 2019 2:44 pm

    TFCFM,

    You are the one that opened the door with your comment of “among these various cases.”

    Someone (else) has put to you a substantive point.

    And now you run away.

    I am shocked; shocked I tell you.

    (Where is my sarcasm sign….?)

  17. B October 6, 2019 5:11 pm

    @ TFCFM “This post, and my comment about it, concern the Athena D v. Mayo decision. Should someone write a comment comparing those two decisions, I’ll be happy to comment there, should I have something relevant to say about the cases or the comparison.”

    Which means you’re a clueless pratt who intellectually condescends on issues you know nothing about. It was a simple question, but it would involve reading the decisions “among these various cases.” However, you can’t even be bothered to read 101.

    @ anon “And now you run away.”

    I finished reading the decisions and briefing on both IGB and CQG. The answer to my own question is: While both sets of claims are valid under 102, 103, and 112, and don’t preempt an abstract idea, in CQG the software is “technological” and contains an “inventive concept” while in IGB the software is not technological and there is no “inventive concept.”

    Now if only these judges can explain how software isn’t “technological” or what the heck an “inventive concept” is I’d be real thrilled.

  18. TFCFM October 7, 2019 9:48 am

    ???

    The post’s author’s and my decisions to comment about one case does not obligate me (actually or logically) to comment about two cases which bother you and do not appear to have any particular relevance to the first case or to my or the post’s author’s comments.

    Even having read your brief “explanation” of the two unrelated cases, I’m hard pressed to identify how or why you believe the two cases to be related to the first. If you’d like to explain the relationship you believe to exist, I might be interested enough to comment upon them.

    Barring that, the only comment that seems fit is, “I’m sorry that these two almost-wholly-unrelated cases bother you, even as I fail to see how you believe they relate to Athena v. Mayo or to my or the original author’s comments.”

  19. B October 7, 2019 12:47 pm

    @ TFCFM “The post’s author’s and my decisions to comment about one case does not obligate me (actually or logically) to comment about two cases which bother you and do not ….”

    Whatever it takes to perpetuate your fantasy that you are a patent attorney. No one believes it.

    “’m hard pressed to identify how or why you believe the two cases to be related to the first”

    Stupid statements like this prove my point. I never said the TT cases were related to Athena. Pathetic duck. Go play fireman or something on another forum.

  20. TFCFM October 7, 2019 1:11 pm

    @B: “I never said the TT cases were related to Athena.

    ???

    Pray, tell why you ask about them then in reply to a comment about Athena, commenting upon a post about Athena?

  21. Anon October 7, 2019 3:03 pm

    or to my or the post’s author’s comments

    tell why you ask about them then in reply to a comment

    TFCFM,
    Maybe because at post 12 YOUR COMMENT
    (“Another possibility is that one of us is able to perceive differences among these various cases.“)
    invites discussion AMONG THESE VARIOUS CASES. Hint: cases being plural is thus NOT CONSTRAINED to the immediate singular case of Athena NOR is it constrained to cases related to Athena.

    B chose a few cases among these various cases — in a DIRECT call on perceiving differences and INVITED you to live up to your boast at post 12.

    This was by any account an on point and substantive matter put to you — the very thing that YOU claim to always be eager to engage and answer.

    You did what you have typically done.

  22. TFCFM October 7, 2019 3:32 pm

    I had supposed it was too obvious to state explicitly. In case that assumption was wrong, let me clearly state that by posting a comment here, I do not commit myself to respond to any topic whatsoever — however tangential or nonsensical it may be to the conversation to which my comment was originally directed.

  23. Anon October 7, 2019 9:23 pm

    (Emphasis added):

    do not commit myself to respond to any topic whatsoever

    TFCFM,

    You do not do your reputation any favors by being an arse and making statements “that clarify” on a point already shown to be within the scope of your statement.

    There is NO “any topic whatsoever” that was put to you. What WAS put to you was directly in line with your statement.

    Apparently the only thing that you “commit yourself” to is to NOT be taken seriously.

  24. B October 8, 2019 2:19 pm

    @ Anon “Apparently the only thing that you ‘commit yourself’ to is to NOT be taken seriously.”

    Amazing how this guy sees himself as the all-knowing master of patent law, yet comes across as clueless and/or evasive in every post.

    A real patent attorney would immediately know that the difference between TT v. IGB and TT v. CQG was total garbage.

    I suppose it was too obvious that you’re clueless and are too petty to admit it.

  25. B October 8, 2019 3:05 pm

    correction: I suppose it was too obvious that TFCFM is clueless and too petty to admit it.

  26. TFCFM October 8, 2019 4:59 pm

    I “admit” that I don’t chase irrelevant tangents, and believe that it’s a good idea for others to act likewise (other than on their own blogs, if they have no interest in remaining on topic). The alternative would appear to be an invitation to have every conversation digress into nonsense. (Hey! Let’s talk about the Redskins’ coaching changes, too!)

  27. B October 8, 2019 6:21 pm

    “I “admit” that I don’t chase irrelevant tangents, and believe that it’s a good idea for others to act likewise . . . .”

    The really sad part about you is that you’re so ignorant you don’t realize how ignorant you are.

  28. Anon October 9, 2019 8:10 am

    B,

    I would turn the phrase about malfeasance and ignorance on its head with TFCFM.

    It is clear that TFCFM is purposefully misrepresenting the points here (as he has done on a habitual basis).

    He attempts to sweep away any actual on point counter and yet professes a desire to engage.

    But to TFCFM, any engagement that does not suit his purpose is defined to be “nonsense and not on point.” His “linguistic tricks” may work for him in his personal dealings (most likely with non-lawyers), but the tricks are not only evident to attorneys, but his insistence and doubling down in their use show that he is disingenuous and more than just a bit of a rube – and his apparently high self-esteem IS more of a product of his refusing to grasp the nuances of patent law. As I have noted previously, he is likely NOT a registered patent attorney and likely does not have any actual hands-on innovation experience. More likely, he has a liberal arts background, and has been at least moderately successful with the “gift of gab.”

    This is beyond “ignorant,” as one who is ignorant would change their behavior when their ignorance is highlighted.

    No. This is purposeful, and thus malfeasance is shown. This is not to say that ignorance may well be ALSO present, but I would not use that term as the predominant description in an exchange such as the immediate one.

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