CardioNet v. InfoBionic: Patenting a Diagnostic Tool

by Dennis Crouch

CardioNet, LLC v. InfoBionic, Inc. (Fed. Cir. 2020)

I have been following this case for the past couple of years because it served as the template for our 8th Annual Patent Law Moot Court at Mizzou back in 2018 (Sponsored by McKool Smith).

In the case, CardioNet sued InfoBionic for infringement (D.Mass.).  The district court quickly dismissed the case for failure to state a claim under R. 12(b)(6) – ruling that the claims of CardioNet’s US7941207 are improperly directed at patent-ineligible concepts under 35 U.S.C. § 101.

The ‘207 patent covers a method for identifying AF (atrial fibrillation and atrial flutter) that is associated with stroke, congestive heart failure, and cardiomyopathy.  The invention particularly monitors heartbeat variability, including identification of irregular “ventricular beats.”  The claims here use off-the-shelf technology to measure heartbeat activity and already existing logic for determining heartbeat variability.  The new feature is claimed as “relevance determination logic to identify a relevance of the variability in the beat-to-beat timing to at least one of atrial fibrillation and atrial flutter” and an “event generator” triggered when variability is “relevant.”  Claim 1 is included below. (Some patent attorneys will point out that that the combination as a whole is also new).

The district court found that the claimed invention completely flows from the unpatentable idea that AF “can be distinguished by focusing on the variability of the irregular heartbeat.”  As such, the claims were deemed invalid.

On appeal, a 2-1 majority has reversed – holding “instead that the asserted claims of the ’207 patent are directed to a patent-eligible improvement to cardiac monitoring technology and are not directed to an abstract idea.”  In making this determination, the court looked to the claim language requirements and also

In particular, the language of claim 1 indicates that it is directed to a device that detects beat-to-beat timing of cardiac activity, detects premature ventricular beats, and determines the relevance of the beat-to-beat timing to atrial fibrillation or atrial flutter, taking into account the variability in the beat-to-beat timing caused by premature ventricular beats identified by the device’s ventricular beat detector. In our view, the claims “focus on a specific means or method that improves” cardiac monitoring technology; they are not “directed to a result or effect that itself is the abstract idea and merely invoke generic processes and machinery.” McRO.

Majority Op. The majority opinion was written by Judge Stoll and joined by Judge Plager.  Judge Dyk concurred in judgment, but dissented from the majority reasoning.

This is a routine case easily resolved by existing precedent. Under that approach, I agree with the majority that the claims have not been shown to be patent ineligible under section 101. I dissent in part because the majority addresses issues never argued by the parties and appears to suggest approaches not consistent with Supreme Court and circuit authority.

Judge Dyk particularly takes issue with the majority’s statements that:

Step one of the Alice framework does not require an evaluation of the prior art or facts outside of the intrinsic record regarding the state of the art at the time of the invention. . . . [Although it] is within the trial court’s discretion whether to take judicial notice of a longstanding practice where there is no evidence of such practice in the intrinsic record. But there is no basis for requiring, as a matter of law, consideration of the prior art in the step one analysis in every case. If the extrinsic evidence is overwhelming to the point of being indisputable, then a court could take notice of that and find the claims directed to the abstract idea of automating a fundamental practice—but the court is not required to engage in such an inquiry in every case.

Majority Op. at 22.  Judge Dyk argues that instead that “limiting the use of extrinsic evidence to establish that a practice is longstanding would be inconsistent with authority. No case has ever said that the nature of a longstanding practice cannot be determined by looking at the prior art.”

= = = =

1. A device, comprising:

a beat detector to identify a beat-to-beat timing of cardiac activity;

a ventricular beat detector to identify ventricular beats in the cardiac activity;

variability determination logic to determine a variability in the beat-to-beat timing of a collection of beats;

relevance determination logic to identify a relevance of the variability in the beat-to-beat timing to at least one of atrial fibrillation and atrial flutter; and

an event generator to generate an event when the variability in the beat-to-beat timing is identified as relevant to the at least one of atrial fibrillation

64 thoughts on “CardioNet v. InfoBionic: Patenting a Diagnostic Tool

  1. 13

    There is also a major procedural issue here. The Federal Circuit held the patent eligible on an appeal from the defendant’s motion to dismiss. In reaching that conclusion, it credited the “facts” in the written description concerning the invention’s advantages and the state of the art. Those “facts” could have been disputed at trial. In a footnote, the Federal Circuit also adopted the patentee’s proposed claim construction. In short, despite potentially disputed factual issues that were necessary to reach the Court’s conclusion on Alice Step One, the Court found the patent eligible as a matter of law under Alice Step One on a motion to dismiss on the pleadings. Perhaps the Court could have reached that result on appeal from a patentee’s motion for summary judgment. But it seems quite problematic on an appeal from a defendant’s motion to dismiss on the pleadings. Might be time for the Fed. Cir. en banc or SCOTUS to tell us where there is a 7th Amendment right to have a jury determine eligibility?

  2. 12

    Come to think of it, longsitting practice (the opposite of longstanding practice) was also prevalent among student groups in the 1960’s and 1970’s. Perhaps it might usefully be revived at the Federal Circuit.

  3. 11

    It occurs to me to wonder whether a beat detector would have been useful for the Beatles, the Rolling Stones, the Kinks and other pop groups not to mention conventional jazz musicians.

    We should perhaps not take ourselves too seriously.

  4. 10

    How can something be determined by a court to be a practice that is longstanding, unless there is evidence of “the longstandingness” of that practice, and how would that evidence be different than evidence that something is prior art?

    Or, have we become a society that permits courts to determine facts without evidence?

      1. 10.1.1

        More lawlessness:

        The U.S. Supreme Court ruled Monday that decisions that an inter partes review petition was timely filed cannot be appealed, restricting the arguments patent owners can make when appealing Patent Trial and Appeal Board decisions.

    1. 10.2

      and how would that evidence be different than evidence that something is prior art?

      Excellent question, but caution is needed here to maintain the difference between something merely being prior art (for either of the two different legal questions of novelty under 35 USC 102 or nonobviousness under 35 USC 103), and the different state of widespread adoption necessary to meet the meaning of the word ‘conventional.’

      Examiners are familiar (even if often in error) with supplying prior art for the different states of 102 and 103. Examiners are c1ue1ess as to what is needed (under the APA and at least the Berkheimer Memorandum) for establishing the proper basis of conventionality (hint: it is NOT established by examiner edict).

  5. 9

    The problem with this is that –in reality– this is indistinguishable from other 101 cases where the CAFC held the claims to be ineligible.

    Data comes in. Data is processed. Do something in response to the data.

    The same thing the judges did in writing their opinion, by the way.

    I don’t understand how the judges can look themselves in the mirror. They must have truly depraved so uls.

  6. 8

    The thing is, is if the CAFC had merely properly cabined the 101 / eligibility test as SCOTUS had intended with Alice / Mayo (though unconstitutional they both be), we would not all be trying to swim in this eligibility morass.

    Makes one wonder how many millions of dollars have been spent / lost trying to so swim?

    And how many inventions have been lost?

    America. Land of the free, enemy of the innovative.

    1. 8.1

      >>enemy of the innovative.

      So because the US arguably fails to reward some innovators, it is the enemy of innovators? Have you heard of the Little Boy Who Cried Wolf?


          It’s a pity you’re too busy escaping the innovator pogroms to attempt to justify the position that the US is the enemy of innovators.



            To the point that “America” itself has become the enemy…

            No doubt, this is meant to be hyperbole. Further, instead of your instant reaction against, maybe pause to see what would support this hyperbole.

            Do you have any doubt whatsoever that the the AIA shows clear signs of legislative capture by those who do not want a strong innovation protection regime?

            Your offering of the fable of the boy who cried wolf shows just how out of touch you are.

            I “get” that you have unthinkingly accepted your indoctrination as an examiner in the “just say no” to patent protection as a good thing (you feel the overwhelming urge to put the NO into inNOvation).

            But for me, I would gladly trade some of that over the top whining for at least the glimmer of reflection of reality that your position lacks.

            Pro Say may have his (her) limits on understanding the legal nuances involved, but has a much better grasp of the bigger picture than you — someone who is supposed to understand far more than a pro se person.

            So yet again, I find myself embarrassed FOR you and your reactions here.


            Again your post drips with attitude Ben. And, again, you play little rhetorical games to try and deflect the topic. Most of us are attorneys. Your games are obviously directed to the those that don’t understand the law and/or technology.

            Pity you could not address the point pro say made regarding the substance of the judgement. But then you never do address substance.


              I don’t understand why you refuse to disown plainly untenable positions advanced by associates. But I don’t mind because I think it undermines your credibility with lurkers. Keep pushing the line that the US government is the enemy of inventors.


                So Ben plays more games. Deflects from what he did and is full of new accusations and new strawmen.

                Dripping with attitude and devoid of substance are all of the Ben’s posts.

  7. 7

    “Judge Dyk argues that instead that “limiting the use of extrinsic evidence to establish that a practice is longstanding would be inconsistent with authority. No case has ever said that the nature of a longstanding practice cannot be determined by looking at the prior art.””

    So Judge Dyk has no problem conflating 101 with 103. I’m not sure if that’s better or worse than what the majority in this panel holds, which in this case worked to the patentee’s benefit but could as easily work to a patentee’s detriment, viz. “I know an ineligible claim when I see it”, without establishing whether or not something was in fact a long-standing practice.

    1. 7.1

      Don’t follow your “conflation” logic. there is a difference between what the skilled person knows and what is obvious to that person. Is Dyk eliding that difference? I don’t see it. but feel free to expand upon your point.

      To grasp what is being claimed, one has to construe the claim through the prism of the person of skill in the art. That person has the “common general knowledge”(cgm) of such a person. That cgm includes what is the “longstanding practice” within that art.

      Only when you have grasped what is he subject matter of the claim can one even begin to think about the downstream enquiry into novelty and obviousness.

      What is it in your point that I not grasping, Atari Man?

      1. 7.1.1

        Max, as someone who’s followed this blog for a long time, this should be self-evident to you by now: 101 only requires that the claim be directed to a product or process. Any other questions – like, was it well-known or routine – don’t belong in the 101 analysis, but rather in the 103 analysis.

        That the members of scotus say otherwise is an unfortunate occurrence, one that CAFC judges and the PTO should work to cabin into as small an area as possible. But Judge Dyk, like too many of his colleagues, clearly isn’t willing to push back in that way. That’s not news, it’s been clear for several years now. His statements in this particular decision just confirm that he hasn’t changed.


          The notion that the hurdle of eligibility can be overcome simply by starting the claim with the word “Process” strikes me as the triumph of form over substance. The 101 enquiry must have more substance than that. At least some subject matter announced as a “process” cannot realistically be eligible.

          What goes for processes must logically apply also to claims that begin with the word “Apparatus” or “Device”. In the Chamberlain case, the court said:

          “The only arguably new element is that the actual information being transmitted is “a status condition signal that: corresponds to a present operational status condition (open or closed).”. Here, something that is well-known or routine is not even “arguably” new.

          Accordingly, given the need to stop Applicants acquiring exclusive rights in abstract ideas, the 101 enquiry will likely include a determination of what is already well-known or routine.

          Personally, I am averse to “abstract” as a 101 litmus test. I prefer the EPO’s “technical character” because I think it easier for the world-wide claim drafting community (given the thousands of final Decisions on “technical character” by the EPO Boards of Appeal to date) to know what will pass muster under the EPC as having “technical character”.

          But perhaps I’m wrong. Perhaps the Fed Ct will soon flesh out with corresponding clarity what is abstract and what is not, what is an inventive concept and what is not. I’m not holding my breath though.


            An abstract idea is not a process.
            An abstract idea is not a machine.
            An abstract idea is not a manufacture.
            An abstract idea is not a composition of matter.

            First and foremost, let’s have a little inte11ectual honesty about what the Supreme Court is actually doing in their “anti-scriviner, form over substance” B$.

            By the way, we’ve been through this loop before. Study some history and what led up to the Act of 1952.


          Atari Man– you are wrong about what 101 requires– the word “claim” is nowhere in 101 (unlike 102, 103 and 112). Rather, it requires that the “invention” be directed to a product or process. You kind of have to know what existed before in order to determine what the invention is.



            … and tell me why if you will, exactly who did Congress bequeath the power and the responsibility for setting exactly what that definition of ‘invention’ is to be?

            Hint: it was not the judiciary.


              Invention is explicitly not the same thing as the “claimed invention”, which is defined separately in USC 100, and what Atari Man thinks 101 addresses. 101 does not address the claimed invention, and as long as you think it does, you will have problems understanding USC 101.

              101 requires asking: Was something invented? If yes, is that invention one of the statutory categories?

              Its tough to answer the first question without knowing what is routine and well established in the art.


                ks, it strikes me that you are on a ramble through Cloud Cuckoo Land. The “invention” is that for which patent protection is sought and how does one determine that, in these days where claims are required to be provided exactly for that purpose, to define the matter for which protection is sought?

                Take the UK Statute, for example. It defines “invention” to include “alleged invention”. That’s so that, in the UK, you don’t have to jump the gun and examine for patentability as part of the examination into eligibility. Same at the EPO. Should be the same at the USPTO, under 35 USC. Interestingly though, the courts of England long ago decided (quite unnecessarily) that the enquiry into eligibility does require fixing what is the “inventive concept”. I wonder how influential those barking-up-the-wrong-tree patent judges in England were on the justices of the appeal courts in the USA.


                I have NO problem understanding 35 USC 101 (you know, the law as actually written by Congress).

                There are TWO things that the law as written by Congress addresses:

                1) Does the invention fit into at least one of the (broadly — and intentionally so — defined) categories, and

                2) Does the invention provide utility within the Useful Arts (and note, this expressly is not limited to the sense of ‘technical arts’).

                ALL else is muckery.

                And you have NOT answered my question as to whom is the power granted by Congress to set forth what is considered to be the invention.

                And you also have not paid attention to the lessons of history and what the Act of 1952 did in regards to the prior open invitation from Congress to the judiciary to set by Common Law the meaning of invention.

                You are going to have to let go your desired philosophy, my friend.


                … and ksksksks, if you are going to want to play the definition game, then I do expect you to provide some reasonable explanation as to how the judiciary is writing out of 35 USC 100 the word ‘discovery.’


              And if you are referring to 112(b), I agree with you that there could easily be a lot more invalidations under 112(b) for inventors who include well-established elements in the body of claims even though they dont recognize those well-established elements as their invention.

              If I discover there is oil under the Hudson River, and I claim: “An oil rig arranged to extract oil from the Hudson River” : do you think I have invented/dioscovered an oil rig, just because it’s part of my claim?

              Like I said: First question, what was invented/discovered (in my exmaple– discovery is there is oil under Hudson River)? Second question: was discovery/invention one of statutory categories (in my example, NO, even though the ‘claimed invention’ is an article of manufacture).


                ks, in your hypo the claim is 100% clear, understandable, enabled, sufficiently disclosed. It passes 101 and 112. As to 102 though, it’s a hopeless fail.

                Perhaps you intended to claim “An oil rig, in use, in the Hudson River”? That would pass 102, 103, 112, would it not?

                1. Not 103? I’m curious. If you were the PTO Examiner, how would you express that objection.

                2. As a whole, a claim to the full set of elements to achieve utility would have been obvious over an exact same oil rig, performing all other elements of the claim with the location not covered by prior art (“notwithstanding that the claimed invention is not identically disclosed as set forth in section 102,” hence passing novelty), but no different in function, way, or results than in another location. “The differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.”

                3. Thanks for writing the obviousness objection. You say that the “result” is the same, regardless of the location in which the oil rig is put to use. Is that really so though. Sometimes you strike oil, and sometimes you don’t, depending on the location. In my book, the results are not the same.

                  Now you might say that the different locations you have in mind are those confined to the set of oil-bearing locations. Trouble is, it wasn’t obvious that the Hudson River belongs to that set.

                  As a matter on which every judge, every lay person, every judge, every jury member could readily agree, as a fact it was not obvious to harvest oil from an oil rig in the Hudson River. So, for me, your reasoning has bit of the Humpty Dumpty about it. Not good.

                  link to

                4. … there is nothing in the claim to any amount of oil reached, plus — as you just admitted, BOTH ‘sometimes you do strike’ AND ‘sometimes you do not strike’ are both known.


                inventors who include well-established elements in the body of claims

                You engage in yet another ‘examiner’ fallacy here, ksksksks.

                You do not get to parse the claims like you attempt here, and dictate that somehow the invention is or is not a single portion of the claims.


            You kind of have to know what existed before in order to determine what the invention is.

            Please show me where Congress provides for this.

            (you are assuming the conclusion for the position that you want to hold)

    2. 7.2

      The problem with Dyk is that he (per the simian in a cage fire-hose training) is looking at the judiciary as having unlimited power to re-write (note, this is specifically NOT ‘interpret’) the law of patent eligibility.

      This is quite evident in the phrase: “No case has ever said that…

      It simply is a non-sequitur to even depend upon whether or not any case has said any type of position. Case law is NOT sacrosanct and UNlimited.

      We (the Royal We) have lost our way, and I place primary blame for this with the Supreme Court and the loss of backbone to attorneys (and lower level judges) to push back.

      The real underlying issue is that the scoreboard is broken.

      Unless and until THAT problem is squarely addressed, ALL ELSE is window dressing.

  8. 6

    This is actually a 3-0 decision. Dyk disagreed with the reasoning of the majority opinion but agreed that the claims are patent eligible “I agree with the majority that the claims have not been shown to be patent ineligible under section 101.”

  9. 5

    relevance determination logic to identify a relevance of the variability in the beat-to-beat timing to at least one of atrial fibrillation and atrial flutter

    Performing a known determination with in a known computer in the dark age of 2004 was non-obvious… no wonder you guys miss the pre-KSR days.

      1. 5.1.1

        Ever notice how Paul Cole’s avatar could be a happy frother of your avatar (with his feet on the ground)…?

  10. 4

    Claimed as a device rather than a method, it seems kosher on the face of it. Would such a device be obvious to PHOSITA? Was that question argued below? Europe says no. Seems reasonable.

    1. 4.1

      Martin, under the EPC, methods of diagnosis, practised on the human or animal body, are ineligible. That’s why there are no method claims.

      The claims are directed to a “system”. But for an issue of eligibility, obviousness of apparatus and method is often the same under the EPC. Suppose the inventive concept is “XYZ”. You can claim that it two ways at the EPO, in the same set of claims, in one and the same issued patent. Method comprising the steps of X-ing. Y-ing and Z-ing. Apparatus comprising means for X-ing, means for Y-ing and means for Z-ing.

  11. 2

    I think the EPO file of patent 1706031 is interesting. See, for example, para 5 of the Office Action of December 2014:

    “the specific manner to determine DDR and to determine DDR in relation to AF, is neither known from nor rendered obvious by, the available prior art.”

    Friends and family members of mine suffer from AF. I’m glad that the EPO recognises AF diagnosis tools as eligible and patentable.

    No opposition was filed against the issued European patent. This is normal. Very often, it does more harm to the Opponent than to the patent owner.

    1. 2.1

      Max, it would be interesting to see actual statistics on EPO opposition success rates. But how many attempted EPO oppositions have well-documented prior art evidence, especially including affidavits, and how many are resolved by contingent amended claims? Nor is there any cross-examination, prior claim interpretation, etc., characteristics of a full inter-partes proceeding.

      1. 2.1.1


        Don’t your points clarify that we have an apples and oranges situation between the two Sovereigns?

      2. 2.1.2

        As anon observes, it’s about as useful to compare the stats of post-grant proceedings at the EPO with those at the USPTO as it is to compare the mortality stats of COVID-19, country by country. Each jurisdiction has its own way of designating what to measure.

        The EPO used to include stats in its Annual Report, which revealed that for the first 20 years of the EPO’s existence, Germans filed 70% of all oppositions. I guess it is still today not much different. Those playing at home are more confident, running out onto the field of play.

        At the EPO, are Opponents successful? Assume that one in every two of your oppositions will “succeed”, to the extent of removing (more or less) the threat that the patentee will emerge from it with claims not wide enough to trouble you. Of course, the canny and competently-advised Opponent succeeds more often than this whereas the less rational and less competently-advised Opponent fails more often than this. Of course, it is not a good idea to fail, for then the patent owner has greater confidence in the validity of the patent and greater willingness to assert it against infringers. Choose your battleground carefully and don’t squander your troops in a battle you can’t win.

        The old rule used to be that out of every three patents opposed, one gets revoked, one gets maintained as issued and the third one comes through with narrowed claims. As the sophistication of drafters, prosecutors and opposers gradually increases, expect an ever-greater proportion of opposed patents to come through, still alive but with narrowed claims. How useful to the business those narrowed claims will prove to be is not easily assessible, even by the patent owner.

        The good thing is the level of legal certainty. Ask a competent European patent attorney whether, on the provided prior art, an opposition will succeed and, because obviousness is so cut-and-dried and clinically objective at the EPO, you will get a confident answer. Armed with that advice, you will oppose successfully the bad patents and leave the good ones undisturbed.



          Yes, I have a question. How “obviousness is so cut-and-dried and clinically objective at the EPO.” Even if you call that an “inventive step,” or whatever, it should logically often have the same difficult fact issue disputes [needing expert opinions, not just EPO attorney or panel arguments] on the state of the art and the general knowledge of those in the art, secondary evidence, etc. There is little opportunity to present evidence against late claim amendments or seek any appeal.


            Paul, the objectivity and legal certainty flows from the EPO-devised “Problem-Solution Approach”. From those who do not understand it, it attracts criticism that it is so savagely prescriptive that it is unfair and often fails to delver justice. They are wrong.

            The point is, the prescriptive approach has the advantage that FTO writers (so long as they are given a competent briefing on the content of the “state of the art”) can tell you, with a high degree of confidence, what is or is not obvious under the EPC.

            It is a TSM approach to obviousness. Contemporaneous affidavit evidence from self-proclaimed technical experts cuts no ice and carries no weight. What counts as evidence of the state of the art is the record that had already aggregated by (at the latest) the day before the date of the claim. Note that the drafter of the claims has access to all this evidence before filing the client’s patent application. If the drafter fails to take it into account, it is the client’s funeral.

            Further, the EPO operates in a civil law environment in which the tribunal is deemed to have enough technical background and experience to decide for itself the common general knowledge of the notional PHOSITA ten years ago. Normally, today’s affidavit evidence on that subject is just piss in the wind.

            As to re-definition of what the invention is, at a late stage in the proceedings, this is not an issue. Any such attempt by the patentee will be “cut off at the pass” by the EPC’s strict filtering out of any “added matter”. You can pursue the invention you announced at the claim’s priority date, but not a claim to an invention you devised after your filing date. You won’t succeed with such a claim in opposition proceedings at the EPO. It will either be refused admission or will fall at the first hurdle, Art 123(2) EPC added matter. Europe is “First to File”. Paris gives priority only for the “same invention”. Drafting your patent application competently is crucially important.




              Your prior detailed reply has been release.

              Notably, you continue to conflate a ‘real person’ aspect with the juristic person aspect of Person Having Ordinary Skill In The Art.

              To wit: “Note that the drafter of the claims has access to all this evidence before filing the client’s patent application.

              Does the drafter have the same omniscient power of a PHOSITA (in certain regards)?

              So while it is a truism that “Drafting your patent application competently is crucially important.” your views tend to conflate that importance with other legal points.

              That’s just not all that helpful, and comes across both naïve and Pollyannaish.


            Martin, my detailed answer has not appeared. No idea why not.

            I omitted to keep a copy. I do hope my answer will be released from the filter, sooner or later.


              Sorry, Paul. I meant Paul. Here a cut-short version of my earlier text.

              Obviousness at the EPO is a TSM approach but savagely prescriptive. Further, at the civil law EPO, the tribunal dons the mantle of the PHOSITA. So, contemporaneous affidavit evidence as to what the PHOSITA knew on the date of the claim is rarely given any weight. What counts is the aggregate content of the state of the art available to the PHOSITA one day before the date of the claim in view.

              Late-filed claims? Because of the savagery of the added matter regime under the EPC, the only narrowed claims you can prevail upon are those directed to the “same invention” as that you announced in the specification, on the filing date of the application.

  12. 1

    Dennis, since this was a split decision, and only on 101 step 1 analysis, do you have to go back and regrade your student exam papers?
    More seriously, since it is way more than a year since this suit was filed, it is now way to late to file an IPR. An IPR may well have avoided all this wasted time and money [with no consideration at all of significant prior art], plus far more money and time that will now have to be spent on D.C. discovery and trial for every other possible issue here, due to relying solely on a 101 based 12(b)(6)motion?

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