Impossibility of the Doctrine of Equivalents?

Enzo Biochem v. Applera (Federal Circuit 2017) (nonprecedential)

EnzoMoleculeThe Federal Circuit’s decision in this case begins with a statement that “this court now has considered this infringement action on three separate occasions over the course of thirteen years of litigation between these parties. We assume the parties are familiar with the background facts, and we therefore recite only those facts relevant to our decision in this appeal.” Enzo/Yale’s asserted patent claims a marked-nucleotide used in genetic research and testing.  The claimed marker is chemically stable and thus an important replacement for the prior art use of radioactive markers.  U.S. Patent No. 5,449,767.  The claims are directed to a particular chemical structure and include the following disputed language: “wherein [Structure] A comprises at least three carbon atoms and represents at least one component of a signaling moiety capable of producing a detectable signal . . . .” (See structure image above).

In its prior decision, the Federal Circuit ruled that the claims only extend to producing an indirectly detectable signal (by binding a secondary directly detectable chemical agent to the marker) rather than being directly detectable (by detecting the marker itself).  Enzo admits that Applera uses a directly detectable marker that doesn’t infringe (under that claim construction), but argues instead for infringement under the doctrine of equivalents (DOE).

On appeal, the Federal Circuit has rejected Enzo’s Doctrine of Equivalents claim (affirming summary judgment of no equivalents) based upon distinguishing statements in the specification.  In particular, the specification explains that indirect detection is superior to direct detection.  That distinction led to the prior claim construction ruling that the claims only cover indirect detection and here.  Following that line of thought, the court here writes:

In Dolly, we concluded that “the concept of equivalency cannot embrace a structure that is specifically excluded from the scope of the claims.” . . . The same principle applies in this case; the concept of equivalency cannot embrace direct detection because it is “specifically excluded from the scope of the claims,” id., as we found in Enzo II. Including direct detection as an equivalent of indirect detection would render meaningless the claim language on which we based our decision in Enzo II; direct detection cannot be an equivalent of indirect detection in relation to these patent claims.

The problem with the analysis here is that the claims do not – on their face – specifically exclude “direct detection” but instead require that infringing structure “represent at least one component of a signaling moiety capable of producing a detectable signal.”  The exclusion of indirect detection came in Enzo II only after “using the specification to more fully understand what the patentee claimed” and considering expert testimony.  (Reminder here that the district court considered the same evidence and determined that direct detection was covered by the claims).

The Problems: In general, this case highlights the difficulties with DOE Doctrine. By definition, DOE only comes into play when the claim terms literally (expressly?) exclude the accused activity.  At that point, a court is asked to focus in on the function-way-result similarities between the claimed invention and the accused activity — a question that usually goes to a jury.  However, the courts are empowered to short-circuit the process and rule-out DOE if the claims expressly exclude the accused infringing mechanism – seemingly making DOE impossible to ever prove. Sad.

 

40 thoughts on “Impossibility of the Doctrine of Equivalents?

  1. “In general, this case highlights the difficulties with DOE Doctrine.” This sentence was cleary written by the Department of Redundancy Department.

    1. So, I drove my car down to the ATM Machine because I needed some money from my IRA Account to get my ABS Braking System fixed, but by the time I got there I’d forgotten my PIN Number. At first I thought my car insurance, which I have through the GEICO Insurance Company, might cover it but they said no way Jose.

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      When I asked my doc for some anxiety meds, he told me, “Well, for your FYI you are actually suffering from RAS Syndrome, not a panic attack”.

      When I got home I looked up RAS Syndrome and read through a bunch of FAQ Questions.

      1. Thank thank you for that that. I’ll venture that you’re a member of the AIPLA association and your kid’s PTA association, that your mother belonged to the NOW organization, that you renewed your driver’s license at the DMV department, and that you watch sports on the ESPN network.

  2. “The problem with the analysis here is that the claims do not – on their face – specifically exclude “direct detection” but instead require that infringing structure “represent at least one component of a signaling moiety capable of producing a detectable signal.” ”

    You can say that again. The claim is closer to excluding indirect detection than it is to excluding indirect detection, implying, as it does, that the component of the signaling moiety produces the signal itself (I thought maybe by waving that CH2 – x part).

    1. argh

      The claim is closer to excluding indirect detection than it is to excluding direct detection, implying, as it does, that the component of the signaling moiety produces the signal itself (I thought maybe by waving that CH2 – x part).

  3. In the second to last paragraph I believe you means to say: “The exclusion of direct detection came in Enzo II..”

  4. “Short circuiting” another trial and appeal with a new [DOE] claim interpretation of the same claims does not seem nearly as “sad” as adding those additional years to the 13 years that this litigation has already dragged on would be. Why should not DOE be required to be argued and supported on a contingent basis in a first trial and appeal?

    1. Good question (no snark) – was the reason why such a DOE being pursued even around at that time of the trial?

  5. This seems to be a straightforward application of specific exclusion, if all the references to direct detection are actually references to autoradiographic exposure methods. That is not clear.
    But first a dumb question: how is autoradiography a direct detection? Can we see the isotopes, or do we detect them only indirectly be detecting their decay particles. Radiography seems pretty indirect, so the emphasis on direct and indirect in the opinion seems a bit off. The real distinction is between radiography, which requires handling radioactive isotopes, and immunofluorescence, which does not (thus the benefits states in the spec).
    And second, a legit question: How did claim 1, which is agnostic as to direct or indirect, get limited to indirect IF? Was this an earlier imposition of the single embodiment rule?
    And third, a legit question: What direct method did the defendant use?
    In the spec, indirect immunofluorescence is compared to “autoradiographic exposure methods,” and was not explicitly compared to direct immunofluorescence. While the opinion states that the patentee said indirect immunofluorescence had “detection capacities equal to or greater than procedures which utilize direct detection, the specification actually says “detection capacities equal to or greater than procedures which utilize radioisotopes.” What supports the misquote? The opinion is not clear on this point.
    Absent equating autoradiographic exposure methods with direct detection, specific exclusion would be supported only by the semantics of the term “indirect” which seems to exclude the possibility of direct as an equivalent, but perhaps indirect immunofluorescence and direct immunofluorescence could be equivalent when compared to autoradiographic exposure methods, especially if direct immunofluorescence has all the stated advantages over autoradiographic exposure method (I think it does). The opinion ignores these factors in favor of the misquote.

    So, Dennis, DOE is not impossible: claims can be, and usually are, agnostic as to specific exclusion.

    MM: Perhaps the inventors and the drafters were emphasizing the patentable distinguishing feature, informed by some insights that suggested that direct immunofluorescence was not sufficient to establish patentability. Or perhaps they weren’t even aware of direct IF.

    1. While the opinion states that the patentee said indirect immunofluorescence had “detection capacities equal to or greater than procedures which utilize direct detection, the specification actually says “detection capacities equal to or greater than procedures which utilize radioisotopes.” What supports the misquote?

      The district court took the position (and it’s not clear to me whether it was a disputed position or not) that radioisotopic labeling of the claimed molecule would allow it to be capable of direct detection. So the “misquote” is just the substitution of the radioisotopic labeling concept for “direct detection.”

      I think it’s important both to avoid getting too bogged down in pseudo-philosophical questions and also important to define terms as carefully as possible … to avoid getting bogged down in pseudo-philosophical questions. For instance,

      how is autoradiography a direct detection? Can we see the isotopes, or do we detect them only indirectly be detecting their decay particles

      The answer is that it’s turtles all the way down.

      Radiography seems pretty indirect

      Compared to what? Beaming photons at an object and detecting the ones that bounce back? Not really looking for an answer but just trying to illustrate the relative aspects of terms like “direct”.

      1. Kudos on the turtles-all-the-way-down reference.

        Direct or indirect compared to what? For IF, the terms refer to the position of the fluorescing molecule, which might be directly bound to the target (right next to it) or indirectly bound to the molecule (attached to a third molecule which itself is bound directly to the target molecule). Both of these are indirect, as is radiography, in the sense that you cannot beam photons at the target molecule and see what bounces back: you attach something to the target molecule, and look for photons/decay particles emitted by the attachment. In this light, the spec would have done better to compare IF (generally) to radiography, or maybe the patentee might have made the point better, or maybe the opinion could have been clearer.

        1. Defining things – with words (which words then may also need to be defined – again, with words) is a natural “turtles all the way down” scenario.

          This is a limitation of human communication.

          1. I think turtles-all-the-way-down is an arcane reference to a statement with a gaping and obvious hole in logic of which the speaker is totally oblivious, but everyone within hearing distance is aware, leading to an outburst of laughter.

                1. Albert Sheu’s answer on Qora is good. You can use the expression as in the Urban Dictionary, instead of Q.E.D., to announce the obvious wrongness of a statement, or you can use the expression in references to someone else’s statement, to imply that it is dopey.

          2. Defining things – with words (which words then may also need to be defined – again, with words) is a natural “turtles all the way down” scenario.

            I’m not sure why you think is an important point but I am sure that nobody cares.

            But please: when your s u ck er clients see their patent flowing down the drain, definitely write a letter to the “rogue” judges mewling out your silliness for everyone to see. You’re a very serious person!

  6. So if I say, in the spec, that two things are substantially different, then I cannot later argue in litigation that those two things are not substantially different. This…. makes sense and probably does not rank among the worst decisions by the Federal Circuit.

    I think the bigger problem here is functional claiming with zero specification support/clarification. The claim reads “at least one component of a signaling moiety capable of producing a detectable signal”, yet the words “signaling moiety” and “detectable signal” are NEVER used in the spec…. When people talk about patent quality, certainly using key claim terminology at least once in the spec probably falls into the scope of such discussion.

    1. The claim reads “at least one component of a signaling moiety capable of producing a detectable signal”, yet the words “signaling moiety” and “detectable signal” are NEVER used in the spec….

      Ouch.

    2. Thanks James. I agree with your statements – certainly not one of the top-ten worst decision by the court.

      Minor quibble with your characterization of what the court said here.

  7. Dennis, but I think the DOE does is substitute one thing or another when the changes are in substantial. But for something critical, the change cannot be so much as to completely eliminate the critical material from the claim. That would not be in substantial change.

    Thus if I claim A + B + C, and it turns out the combination is largely old but the new part is a particular, claimed , aspect of C, the DOE would extend to variations on A and B, and on the generic aspects of C, but not on particular aspects of C that made the whole combination allowable the first place.

    1. Ned, I like your approach, but it is not really that of the Federal Circuit. Based upon our prior discussions, I assume that your meaning of “substantial” vs “insubstantial” change would turn on whether the difference is at a “point of novelty.”

      1. Dennis, you got my drift.

        As to the Federal Circuit, I think they will tend to go in the direction I suggest over time. It makes a lot of sense. Further, it appears that people on the court and/or practitioners read what I post here on Patently-O and sometimes it changes their views.

        I am pretty sure for example that Judge Dyk, or practitioners briefing him, got their ideas about on sale bar and its connection to Pennock v. Dialogue because I have been saying that very same thing here for very long time. Ditto the lack of standing of the government to challenge a patent for validity in a court of law.

        Then of course, there is MCM Portfolio LLC.

        1. Further, it appears that people on the court and/or practitioners read what I post here on Patently-O and sometimes it changes their views

          WAY too full of yourself there Ned.

            1. Ned being too full of himself is Ned being too full of himself.

              Why would I be jelly of that?

              Why do you think the Supremes passed on his case if he were indeed all that and a bag of chips?

      2. Could also be point of non-obviousness, so to speak, where the combo wasn’t just non-obvious because the whole thing as a whole was non-obvious.

        I would think anyway.

  8. What’s most sad is how long this dispute dragged on. In part, that’s because Enzo was given a narrowing claim construction by the CAFC in lieu of seeing its claim tanked by the CAFC (for lack of written description and enablement; see page 8 of the opinion). The key language (as paraphrased by the district court):

    “The district court explained that the patent “describes its method of indirect
    detection as a superior means of detection as compared to direct detection, with ‘detection capacities equal to or greater than products which utilize’ direct detection.”

    CAFC opinion at bottom of page 10.

    But once the CAFC’s claim construction was handed down, that should have ended the litigation. In this context, where the value is nearly 100% in the detectability of the molecule, a claim limited to “capable of producing an indirectly detectable signal but not a directly detectable signal” is never going to be deemed “equivalent” to the feature of “capable of producing a directly detectable signal.”

    Going back to the roots, I wonder why the application drafter didn’t dial back the language a bit. Why not just describe the direct and indirect detection as alternative embodiments, each with its own advantages / disadvantages depending on the context? We’ll probably never know. But therein lies the real lesson of this case, I think.

    1. MM, given the language you quote, I think the answer to the question is that the patent attorney on drafting the application did not understand the inventors invention to be anything other than a means of providing indirect detection. That is probably what the inventor told the patent attorney. It is only during prosecution that the prosecuting attorneys realize they could get broader claims and attempted to do so.

      1. Ned: Since this is a university application, it is possible that the patent drafter never communicated directly with the inventors, and neither grasped the commonalities and differences between IF (direct and indirect, which are both indirect detection techniques) and indirect detection techniques such as radiography. This is pretty subtle stuff, so I wonder how many of us would have addressed it.

        1. DC, you floored me there were that one. Are you telling me that university applications are (typically?) prosecuted by patent attorneys who never talk to the inventors?

          1. It seems fashionable for TTO’s to insulate the inventors from the outside patent attorneys. Maybe it’s a cost cutting measure. It is common in my experience, which is not broad enough to say whether it is typical.

            1. For what it’s worth, my experience has definitely involved more inventor involvement during both the drafting and prosecution stages, but like you I haven’t had enough experience with different universities to have any idea what is typical.

            2. In my fairly limited experiences with universities (a few universities, and a handful of apps each), it’s not that the TTOs are insulating the inventors, it’s just that it’s like pulling teeth to get the profs to provide additional information, review drafts, etc.

              They’re pleasant enough to deal with in the initial invention disclosure review, but thereafter… hey, they’re busy.

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