Arguing Device-and-Method Eligibility Under the Present and Future States of U.S. Patent Law

“Considering the innumerable ways that the issues could play out, your goal ought to be to make a record showing that your client’s claimed subject matter is patent eligible and enforceable, regardless of what legal standards are eventually formally adopted, or how they would be implemented.” with Alice’s birthday week, Dan Hanson examines practical solutions for navigating the law as it is—and as it could be.

Here’s the hypothetical: A patent application has been filed for a new medical device. The device reads various physiological signals from a patient and presents, with previously unheard-of accuracy and reliability, the condition of the patient’s immune system.

Your client, who made a heavy investment in research and development of this device, wants U.S. patent protection, and is willing to pursue remedies in court if necessary. The subject matter has been claimed as a device and as a method. The claimed method recites actions performed with the physical components of the device.

To your client’s disappointment, a hypothetical examiner has rejected the claims as patent ineligible under section 101. The examiner relied principally upon the case of Electric Power Group, LLC v. Alstom, 830 F.3d 1350 (Fed. Cir. 2018), concluding that the method claims and the device claims “are directed to a patent-ineligible concept, namely, collecting information, analyzing it, and displaying certain results of the collection and analysis.”

If the “directed to” inquiry means that patent eligibility depends upon what the device does, then the examiner has a legitimate point invoking the Electric Power case. Your client’s device does indeed collect information, analyze that information, and display the results of the analysis.

Even though the examiner had a legitimate point, that does not mean the examiner is correct; but it does mean that there is a good chance that the examiner will not reverse the stated position on ineligibility. You have, therefore, advised your client of the foreseeability that your quest for patent protection will have to go to the Patent Trial and Appeal Board (PTAB), and may well end up in court. Your client is ready to go the distance.

Your immediate job is to respond to the pending rejection. You must argue in favor of patent eligibility under section 101. You must preserve the arguments you expect to make in the foreseeable appeals, even if you have confidence that the examiner’s ruling on patent eligibility will not be reversed by the examiner. You do not want to be in the position where an appellate tribunal points out that you are making arguments for the first time on appeal.

The Basic Arguments

You will, of course, be making the basic arguments. You’ll be arguing that the claims are not directed to collecting, analyzing, and displaying of information; rather, they are directed to a particular novel apparatus and a method of using that apparatus. You’ll be arguing that the Electric Power Group case is on your client’s side, in that your claims recite “inventive technology” that Electric Power Group says is patent-eligible, 830 F.3d at 1354. You may also argue in the alternative that Electric Power Group is less applicable than cases such as Thales Visionix Inc. v. United States, 850 F.3d 1343 (Fed. Cir. 2017), which found that a new apparatus was patentable, even if the claimed subject matter recited sensors and apparatus that received and processed signals from those sensors.

You’ll be arguing how Alice Corp. v. CLS Bank Int’l, ___ U.S. ___ (2014), especially its so-called two-part test, supports your client’s position on patentability. You’ll be arguing that cases subsequent to Alice further show that your client’s claims are patent eligible.

You may also argue that, as pertaining to the device claims, history is on your side. Your client wants to patent a medical device, and medical devices historically have been patentable. Also, it is a fundamental and long-standing legal principle that “apparatus claims cover what a device is, not what a device does.”  Hewlett-Packard Co. v. Bausch & Lomb, Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) (emphasis in original). Accordingly, it was error for the examiner to reject a device claim on the basis of what purposes it serves, rather than what it is.

You may also consider making an argument concerning the method claims, as was set out by Christopher Hall in his essay several months ago. You may argue that no abstract idea addresses the limitations of the prior art, and this means that your client’s claimed subject matter is “something more” than an abstract idea.

There Is a Conundrum: Where is the Law Going?

The basic arguments address the law on patent eligibility as it exists today. But will claims that are determined to be patent eligible today be patent eligible (or if eligible, will those claims be enforceable) in the future?

Right now, there is talk about overhauling the rules for patent eligibility, such as by new federal legislation or by effective advocacy in the courts. There is some concern that, contrary to all hope, federal legislation and court decisions may make things more murky for your client than they currently are. Who knows what forms of analyses will be in fashion when someone decides to argue to a government tribunal that your client’s patent never should have been granted in the first place, or that your client’s valid patent ought not to be enforced?

Who can say how the law will evolve? One possible scenario for the future is that the so-called judicial exceptions to patent eligibility will be wiped away, in whole or in part. Another scenario is that some exceptions will be codified by statute, and others will be abolished.

Could the Section 101 Exceptions Exist as Something Else?

There is at least one other scenario that patent practitioners perhaps ought to recognize:  many (if not most) of the judicial exceptions will continue to exist, but will be subsumed within other parts of patent law. They may not be thought of as “exceptions” to patent eligibility, but they may be incorporated into already-existing jurisprudence.

In Alice, the Supreme Court said, “We have described the concern that drives this exclusionary principle as one of pre-emption.” Even if the section 101 exceptions were to be totally abolished by legislation, the Court’s pre-emption concern would still be present.

The concern about pre-emption can be, to some extent, a concern about claim overbreadth (if not outright greediness). Fortunately, there already exists jurisprudence about claim overbreadth, including jurisprudence pertaining to anticipation and obviousness. Pre-emption can also be framed as a problem of enablement or description, and jurisprudence already exists to deal with such issues. It is also possible that pre-emption may be addressed in litigation as an issue of equity or damages.

Patent practitioners ought to recognize that the Supreme Court will not simply forget about its pre-emption concern; and that judges will always have ways to address a pre-emption concern, even without resort to the jurisprudence of section 101. When such a concern arises, judges (and to some extent, the USPTO) will be hesitant to reach impractical or inequitable results. For example, what judge is going to enforce a “mental steps” patent that can be infringed merely by talking about it or thinking about it?  What judge is going to rule that a patent-holding corporation can own or have rights to the body of a human being without that human’s consent?  What judge is going to allow someone to sue to stop others from applying a “discovered” mathematical formula?

The point is that, even if patent eligibility jurisprudence is clarified, the concerns that led to creation of the section 101 exceptions in the first place will persist; and if not addressed by section 101 jurisprudence, those concerns could well be addressed elsewhere.

What Your Goal Should Be

Considering the innumerable ways that the issues could play out, your goal ought to be to make a record showing that your client’s claimed subject matter is patent eligible and enforceable, regardless of what legal standards are eventually formally adopted, or how they would be implemented.

Making such a record can be a hedge against future challenges. It would be making a record that would say to a judge, “You don’t have to re-evaluate the law or consider any new or special rules or exceptions for our case.”

Start by considering what kinds of human creations are never, ever going to be awarded an enforceable patent. Consider also those kinds of human creations that are or will be patentable, but that have a very difficult path to patentability. And consider the kinds of subject matter that, even if patentable, is unlikely ever to be seriously capable of being enforced in court.

Then argue that your client’s claimed subject matter is not of those kinds.

Such an argument is part law, part public policy, and part public relations. Such arguments are more likely to find favor with a court than with the USPTO, but you want the arguments on record anyway.

Argue What Your Client’s Invention Is Not

There have been, and always will be, “gray areas” about which sorts of claims deserve patent protection and which do not. Make an argument that that your client’s claims are not in any gray area that has ever been articulated.

What follows is a non-exclusive list of some of the areas of subject matter that historically have been troublesome, if not verboten. Argue, helpfully with supporting quotations from your claims or description, that your client’s claims clearly do not fall into any of these categories:

  • They are not directed to subject matter outside the technical arts.
  • They are not an original work of authorship nor an expression of an idea.
  • They are not an “idea of itself,” such as a principle, an original cause, or a motive.
  • They are not a mental process nor mental steps.
  • They are not a business method or apparatus to implement a method of conducting business, or managing risk, or implementing an economic practice prevalent in a system of commerce. (Let’s face it: pure business methods are troublesome in the patent world; and for your client’s case, none of those troublesome aspects are relevant.)
  • They are not a method of organizing human activities.
  • They are not a law of nature. (Since all devices in this universe must operate according to the laws of nature, claims to a device that obeys natural laws are not claims the natural laws themselves.)
  • They are not a natural phenomenon. (A new apparatus that responds to a natural phenomenon is not the phenomenon itself.)
  • They are not a naturally occurring thing or process.
  • They are not a living thing or part of a living thing.
  • They are not a mathematical formula, either contrived or descriptive of a natural phenomenon, nor a mathematical relationship. (Even if the claims include a mathematical formula, it does not mean that the formula itself is claimed for all intents and purposes.)
  • They are not a bare signal.
  • They are not routine automation, or a generic computer implementation, of something done previously. (You may find it helpful to quote from your own patent application’s description in support of this argument. If the examiner has also made an anticipation or obviousness rejection, you may refer to your rebuttal there for support of your argument that the claimed subject matter has never existed previously.)
  • They do not recite an apparatus that is only a computer.
  • They are not pure software, nor do they claim merely a storage device for holding software, nor do they invoke a computer merely as a tool.
  • They do not preempt all fields of usage.
  • They are not wholly intangible.
  • They do not recite apparatus for insignificant post-solution activity; nor is the recited apparatus related to pre-solution activity.
  • They do not lack a machine or a transformation of something in the real world.
  • They do not recite any method implemented entirely on an unspecified apparatus.
  • They do not merely manipulate an intangible idea and solve a purely mathematical problem without limitation to a practical and concrete application.
  • They do not recite something that fails to produce useful, concrete and tangible results.
  • They are not directed to a mere result, with nothing recited pertaining to accomplishing that result.

In the hypothetical medical device case, it ought to be clear from the patent application itself that none of these questionable categories is applicable. Therefore, there ought to be no serious concern about unfair pre-emption.

When you point out that your client’s claims clearly do not fall into any of these questionable categories, then you will have a record supporting your client’s invention as patent eligible and enforceable regardless of what tests or analyses are eventually adopted by Congress or the courts.


Warning & Disclaimer: The pages, articles and comments on do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author as of the time of publication and should not be attributed to the author’s employer, clients or the sponsors of Read more.

Join the Discussion

11 comments so far.

  • [Avatar for Daniel Hanson]
    Daniel Hanson
    June 20, 2019 11:17 am

    Paul Cole Comment 6:

    For what it is worth, I find Judge Newman’s dissent in the Athena case to be more logical and persuasive than the majority opinion, as well as more in line with precedent and more practical.

    If you have seen my remarks about the Alice case in the June 19 “Stakeholders Comment” posting, you have seen that I echo Judge Newman from Athena: a claim ought to be analyzed as a whole.

    Also, my essay above indicates that the so-called “natural law” exemption ought to be interpreted very narrowly, because all devices (and for that matter, all physical processes) in this universe must operate according to the laws of nature.

  • [Avatar for Anon]
    June 20, 2019 09:53 am

    Mr. Cole,

    What I find idiotic is taking ANY negative criticism and portraying it as somehow not on point, or not worth reflecting upon.

    Maybe instead of trying to not understand, you take the negative criticism and do something constructive with it.

    As to any “principles features,” all you have to do is pay attention to my posts over the last several years. The fact of the matter it that MUCH of this mess is Court-induced, and your desire to find “cases” that support features is very much part of the problem of NOT recognizing and acknowledging that the scoreboard is broken. As to “support” for this notion, such can easily be found in comments from members of ALL THREE BRANCHES (including commentary of past and present judges of the CAFC, Director Iancu, and members of Congress).

    I invite you NOT to write such that the criticism comes across as “mindless.” This can be constructively accomplished if you — as noted herein — actually pay attention to the posts already of record. When YOU do not do so, and post items that have already been critiqued, then the post in reply of your asserted “mindless” criticism is all that you deserve.

  • [Avatar for Paul Cole]
    Paul Cole
    June 20, 2019 01:31 am


    Any indication as to what the vexed words “directed to” might possibly signify is extraordinarily helpful. It is not a matter of agreeing but of trying to figure out what the court is doing insofar as that is possible even if a personal view is that what it doing is profoundly wrong in many instances.

    The reminder of Judge Linn’s opinion in Chicago Transit is nevertheless very helpful. If you look at my Patent Docs comment on that case, you will see a recommendation that inclusion of a turnstile as a feature of the claim might have been very helpful.

    @ Anon

    Negative criticism is an easy option and any idiot can indulge in it. What are the principal features of the current mess that YOU consider need to be understood and what are the cases that support those features? How about doing some CONSTRUCTIVE WORK for a change instead of mindless criticism of others.

  • [Avatar for Anon]
    June 19, 2019 02:36 pm

    I certainly hope that Mr. Cole seriously updates his understanding of the current mess in US patent law prior to ANY capacity as an editor writing about the situation.

  • [Avatar for B]
    June 19, 2019 12:33 pm

    @ Paul Cole “The meaning of the vexed words “directed to” has been an enduring puzzle. The explanation that the “directed to” inquiry means that patent eligibility depends upon what the device does is extraordinarily helpful . . . “

    Helpful? I respectfully disagree and for the same reasons set forth in Judge Linn’s dissent in Smart Systems v. Chicago Transit. In fact, I’ll go so far as to say that the “directed to” test is the most useless and moronic nonsense the Supreme Court ever spewed on paper. Ignore enough limitations and there’s always something abstract.

    Have you ever heard of a case that wasn’t directed to an abstract idea?

  • [Avatar for Paul Cole]
    Paul Cole
    June 19, 2019 08:09 am

    In my capacity as an editor of the CIPA Guide to the Patents Acts I am in the process of updating our Section 001 eligibility and was in fact working on it yesterday evening. Although our focus is on UK and EPC opinions, we briefly cover US opinions since an awareness of the potential pitfalls in the US to UK and European practitioners is of self-evident importance to our local applicants.

    The meaning of the vexed words “directed to” has been an enduring puzzle. The explanation that the “directed to” inquiry means that patent eligibility depends upon what the device does is extraordinarily helpful and does much to explain why claims directed to diagnostic methods have so frequently been held unpatentable.

    In particular, it may be helpful for readers to cross-refer to my IPWatchdog posting of 23 May on the Athena case where an en banc petition is currently pending. The outcome of the claimed process indeed is information concerning the disease state of the subject, but the process is carried out in vitro and involves three apparently novel materials, all of which qualify as compositions of matter, the last of which qualifies as a manufacture, the overall method being a prima facie eligible transformative process. The fact pattern is utterly different from that in Mayo, where there was nothing new and transformative produced by the hand of man, merely information as to the upper and lower limits of the therapeutic window.

    Daniel’s view as to how the positive case on eligibility in Athena can be reconciled with the negative opinion of the panel majority in Athena would be of considerable interest.

    In the meantime, sincere congratulations on the publication of such a useful and informative posting.

  • [Avatar for don quixote]
    don quixote
    June 19, 2019 08:01 am

    I don’t know of a single experienced patent litigator that wouldn’t be thoroughly pissed off that a piss-ant patent prosecutor tried to preemptively make defensive statements/arguments on the record for every potential line of attack on a patent that the litigator would like to develop for him/herself in the event of litigation.

  • [Avatar for Concerned]
    June 19, 2019 07:39 am


    I am just a little common person with one invention and what you said sure was my experience.

    It did not matter what argument or evidence was provided, the application was dead on arrival.

    I would take a jury of my peers over this patent process any day. The jury may not know all the legal mumbo jumbo, however, the common folks on a jury know right from wrong.

    I think once the jury heard working professionals and experts have been looking for the solution since day one, here is your patent, what’s the problem?

    And then once that question cannot be answered, you get to the real question: What is really going on?

  • [Avatar for Anon]
    June 19, 2019 05:38 am

    Curious alights upon one of life’s most frustrating truisms:

    Arguments only matter if the people to which these arguments are directed actually consider them.

    There are times that this matters more than others, and even if frustrated, to persevere is sometimes the only option.

    It matters not how many times I am knocked down, it matters how many times I get back up.

    “I can do this all day.” – Steve Rogers.

  • [Avatar for Curious]
    June 18, 2019 09:05 pm

    I’ll echo Anon’s comment.

    Also, from my experience, examiners don’t necessarily following USPTO guidance or Federal Circuit law. The Federal Circuit also doesn’t necessarily follow Federal Circuit law. As with most instances dealing with 101, who is the examiner (or what art unit the examiner is examining in) or on the panel at the PTAB or Federal Circuit will be the determining factor.

    Arguments only matter if the people to which these arguments are directed actually consider them.

  • [Avatar for Anon]
    June 18, 2019 06:43 pm

    Am interesting read, but an altogether unfollowable bit of advice.

    Or was that the point?