CAFC on Patent-Eligibility: A Firestorm of Opinions in Classen*

Just as all of us have slowly started to absorb the implications of the remand in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, as well as the triumvirate of opinions in Association for Molecular Pathology (AMP) v. USPTO, on the standard for patent-eligibility under 35 U.S.C. §101, the Federal Circuit (finally) issued its long awaited (by some of us) remand decision in Classen Immunotherapies, Inc. v. Biogen IDEC. That there was a majority (and a dissenting) opinion in the remand of Classen wasn’t surprising. But that there was yet a third “additional views” opinion would likely not have been predicted by anyone. And it is that “additional views” opinion, along with the majority and dissenting opinions, that will certainly generate a “firestorm” through the Federal Circuit, and which may eventually reach the Supreme Court. The judicial donnybrook on the question of what the standard is (or should be) for patent-eligibility under 35 U.S.C. §101 is about to begin in earnest.

As my fellow patent attorney, Kevin Noonan, poignantly says on Patent Docs, the Classen remand decision “[couldn’t] be more different from the Federal Circuit’s earlier decision.” That earlier decision (with Judges Moore and Newman on the panel), which came out not long after the Federal Circuit’s famous (and some would say “infamous”) en banc Bilski decision, is astounding for its brevity (one paragraph of 69 words), or as Kevin also poignantly observed, the claimed method was longer than the opinion by 20 words. As I also commented when that earlier opinion came out, it was ghastly for completely failing to explain how the “new” Bilski “machine or transformation” test was applied to the claimed method. See CAFC: Method for Calibrating Drug Dosage is Transformative.

Compared to the “nanomeric” earlier decision (which was also deemed “non-precedential”), the Classen remand decision is a veritable treatise (and very precedential one at that) at a “robust” 57 pages. Briefly, Classen involved three related patents (the ‘739 patent, the ‘139 patent, and the ‘283 patent) directed generally to a method for essentially evaluating an immunization schedule for a treatment group, relative to a control group. But where the ‘739 and ‘139 patents differ from the ‘283 patent is in how this immunization schedule calibration method is claimed (and which became a contentious issue between Judge Newman and Chief Judge Rader in the majority, and Judge Moore in the dissent). In the ‘283 patent, this immunization schedule method is claimed simply as “immunizing” the mammals in the control group according to the immunization schedule and then “comparing” the “incidence, prevalence, frequency or severity of [the] chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.” (As my patent attorney brother Mark has astutely observed, how the method is claimed in the ‘283 patent leaves much to be desired because it never says what “end result” is caused by this claimed method). By contrast, the ‘739 and ‘139 patents start out similarly to the ‘283 patent in defining the claimed method initially as “screening a plurality of immunization schedules” by “identifying” first and second groups of mammals, “immunizing” the first and second groups by different immunization schedules, and then “comparing” the effectiveness of the different immunization schedules. (A side note: the “comparing” step also recites that the “screened immunization schedules may be identified as a lower risk and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing [the] chronic immune mediated disorder(s),” which raises another “can of worms” with regard to the underlined word, also noted by my brother Mark, as to whether the 739 and ‘139 patent claims would even pass muster under 35 U.S.C. §112, second paragraph.) But where the claimed methods of the ‘739 and ‘139 patents part company with the ‘283 patent is in an additional “immunization” step which is carried out on a “subject” by using the “lower risk” immunization schedule (characterized by the majority opinion as the “optimum schedule”) that resulted from the initial “screening” step. (Or to use my brother Mark’s words, we now have an “end result” caused by the “immunization” step of the method claimed in the ‘739 and ‘139 patents.)

The district court ruled (on summary judgment) that the claimed methods in all three patents were invalid as being patent-ineligible under 35 U.S.C. §101, stating that these claims “describe little more than an inquiry of the extent of the proposed correlation between vaccines and chronic disorders.” As Judge Newman and Chief Judge Rader were to lament in their respective majority and “additional view” opinions, the district court’s haste in ruling the claims in these three patents invalid based solely on 35 U.S.C. §101 created a sparse factual record, and particularly an appeal record bereft of questions relating to other “substantive criteria of patentability” under 35 U.S.C. §§ 102, 103, and 112. In fact, Judge Newman and Chief Judge Rader freely acknowledged that these claims “may not meet the substantive criteria” of one or more of other patent statutes (see my comment above relative to the “may” recitation in the claims of the ‘739 and ‘139 patents). But in an additional collective judicial “sigh,” Newman and Rader observed that these other questions of “patent validity are not before us on this appeal,” and “the only motion for summary judgment under these substantive provisions was based on prior use” asserted by the accused infringer (Merck) which “was denied by the district court because facts were in dispute,” such a denial “not [being] appealable.”

The majority opinion by Judge Newman (joined by Chief Judge Rader) provides an excellent summary of the case law history on determining patent-eligibility under 35 U.S.C. §101 and its predecessor statutes. Of significant note in this majority opinion was its emphasis on the stated concern from the Supreme Court’s Opinion of the Court in Bilski v. Kappos about “barr[ing] at the threshold [inquiry of patent-eligibility]” and thus “encouraging preservation of legal and practical distinctions between the threshold inquiry of patent-eligibility and the substantive conditions of patentability [as reflected in 35 U.S.C. §§ 102, 103, and 112].” Newman’s opinion then followed with a discussion of “mental steps” (which the district court also asserted were present in invalidating the method claims of the three patents), and that the mere “presence of a mental step is not of itself fatal” to patent-eligibility under 35 U.S.C. §§ 101. Newman’s opinion also refreshingly restated the caution from Chief Judge Rader’s 2010 opinion in Research Corporation Technologies, Inc. v. Microsoft Corporation that “claims must be considered as a whole when determining eligibility to seek patentability,” and which “described the statutory role of [35 U.S.C.] § 101 as a ‘coarse eligibility filter’, not the final arbiter of patentability.”

Judge Newman’s majority opinion then dug into the language of claims of the three patents (something which Judge Moore should have done but didn’t). Judge Newman especially noted the significant difference between what was claimed in the ‘739 and ‘139 patents, versus what was claimed in the ‘283 patent (a “not so subtle” difference unfortunately completely lost upon Judge Moore who said “I see no distinction between the ’283 claims and ‘139 and ‘739 claims which warrants differing treatment”). As Judge Newman astutely observed, the ‘283 claims of the patent “stand[] in contrast the ’139 and ’739 patent claims, which include the subsequent step of immunization on an optimum schedule.” With that significant difference in mind, Judge Newman’s opinion ruled that the ’139 and ’739 patent claims passed the “threshold inquiry” for patent-eligibility under 35 U.S.C. §101, while those of the ‘283 patent did not.

In the verbiage of Judge Newman’s opinion for why the ’139 and ’739 patent claims passed the “threshold inquiry,” while those of the ‘283 patent did not, resides the following “kernel of truth”: “The ‘283 [patent] do not include putting this knowledge [of immunization schedules] to practical use, but are directed to the abstract principle that variation in immunization schedules may have consequences for certain diseases” (emphasis added).  (Judge Newman also paid homage to the Prometheus remand in noting that the “immunization”step in the ‘739 and ‘139 patent claims was also “transformative.”)  Could Judge Newman have been making an oblique reference to the discarded “tangible, concrete, and useful result” test? Perhaps, but as Judge Newman certainly realized, she was barred from a direct reference by Federal Circuit precedent, namely their en banc decision in In re Bilski.

An unfortunate “casualty” from the Federal Circuit’s en banc decision in Bilski (besides the inane “machine or transformation only” test) was dumping the “tangible, concrete, and useful result” test for judging patent-eligibility. Frankly, the “tangible, concrete, and useful result” is the only objective test for judging patent-eligibility that has been articulated by any court. All other efforts to define patent-eligibility are phrased in terms of “exceptions” (e.g., it can’t be merely “an abstract idea, natural phenomena, or discovery of a law of nature”), and ultimately reduce down to a subjective “I know it when I see it” standard. Now that the Supreme Court has said in its Bilski v. Kappos decision that the “machine or transformation” isn’t the exclusive test for patent-eligibility, the Federal Circuit would be wise to take that as a “cue,” and bring back the “tangible, concrete, and useful result” test (call it a “standard” if you need to avoid the potential taint of “inflexibility” that has unfortunately been inflicted by the Supreme Court on such tests) pronto before the “fiery furnace” of 35 U.S.C. §101 gets any hotter. And an en banc rehearing in the Classen remand (which appears likely) would be the perfect vehicle to do so.

The “plot” in the Classen remand truly “thickened” with the “additional views’ opinion authored by Chief Judge Rader (also joined by Judge Newman). To put it mildly, the Chief Judge “let it all hang out” (and rightly so) by essentially castigating the “rising number of challenges under 35 U.S.C. §101.” For example, Rader (somewhat sarcastically) observes that:

Subject matter eligibility under section 101 has become the “substantive due process” of patent law – except that reading non-procedural requirements into the constitutional word “process” has more historical and contextual support than reading abstractness into the statutory word “process” because Title 35 already contains ample protections against vague claims.

Amen to that observation by the Chief Judge!

Even more astute are Rader’s observations on the “unintended implications” of patent-eligibility under 35 U.S.C. §101 being used as a “coarse filter that excludes entire areas of human inventiveness from the patent system on the basis of judge-created standards.” One such “unintended implication” is what the Chief Judge refers to as “claim drafting evasion,” which he characterizes (accurately) as adding “to the cost and complexity of the patent system and may cause technology research to shift to countries where protection is not so difficult or expensive.” Rader also gives two good examples of such “claim drafting evasion,” one of U.S. vintage called “Beauregard claims” (“devised to draft around restrictions on software imposed [in the Supreme Court’s 1972 decision] in Gottschalk v. Benson,” a monstrosity of an opinion based on the all too apparent technological ignorance of the Supreme Court), the other of European vintage called “Swiss-style claims” (to “draft around restrictions on medical treatment methods imposed by the European Patent Convention,” which creates some really bizarre claim language, typically in the form of “the use of a compound X for the manufacture of a medicament for the treatment of disease Y”). As Rader adroitly (and in my opinion, correctly) notes, these “claim drafting evasion” techniques are spurred by “our national innovation policy tak[ing] on characteristics of rewarding gamesmanship.”

While the Federal Circuit has certainly been a “culprit” in creating this “gamesmanship,” the ultimate “villain” in this “tragedy” is our Judicial Mount Olympus, the Supreme Court. See Through the Fuzzy Bilski Looking Glass: The Meaning of Patent-Eligible under 35 U.S.C. §101. Starting with Gottschalk v. Benson in 1972, and ending with Bilski v. Kappos in 2010, our Judicial Mount Olympus has primarily hurled destructive thunderbolts at the Federal Circuit, and its predecessor, the Court of Customs and Patent Appeals (CCPA), on what is the appropriate standard for determining patent-eligibility under 35 U.S.C. §101, thus forcing us “mere mortal” patent attorneys and agents to resort to such “gamesmanship” described by Chief Judge Rader to protect (appropriately in my view) the rights of our clients. The Supreme Court has now so “mucked up” the patent-eligibility standard in its Bilski v. Kappos decision that we “mere mortals” are left with no objective definition to work with of what an “abstract idea” is (the only point I agree with in Justice Stevens concurring, and in actuality, dissenting opinion in Bilski v. Kappos). No amount of smirking, arrogance, or reveling in their technological ignorance can hide the fact that the Supreme Court has failed (miserably in my view) in rendering any “order” out of the “chaos” of what is the appropriate standard for patent-eligibility under 35 U.S.C. §101.

The remand in Prometheus is now before the High Court. The likelihood is that the remand the decision in Classen, as well as the decision in AMP, will end up there as well. The High Court would do well to “humble itself,” cast aside its thunderbolts (and arrogance), listen to those who are technologically savvy (and know quite a bit more about patent law), and especially pay close attention to the majority and “additional views” opinions by Judge Newman and Chief Judge Rader in the Classen remand. The time for smirking and arrogance is OVER when it comes to rendering “order” out of the “chaos” that the patent-eligibility standard has now become. And please IMMEDIATELY resurrect the objective “tangible, concrete, and useful result” test for judging patent-eligibility under 35 U.S.C. §101 before hell truly descends on all of us “mere mortals” below.

*© 2011 Eric W. Guttag.


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Join the Discussion

13 comments so far.

  • [Avatar for patent enforcement]
    patent enforcement
    September 5, 2011 04:33 pm

    Decisions like this one may render it all too easy for clever patent claim drafting to compensate for weaknesses in a supposed “invention.”

  • [Avatar for Blind Dogma]
    Blind Dogma
    September 3, 2011 09:06 am

    I offer a slightly different perspective to a (recently) well worn debate (no ice picks required):

    There is an underlying sense of a need of having a judicial Patent Watchdog and 101 is the billyclub of that watchdog. The courts want (need?) a nose of wax to be able to constrain where patents are in play and where they will be kept out of. All one has to do is take a step back, look at the competing philospohies and doctrines, see their ebb and flow, see which camp has advanced what theories to what success at what times and one can easily see that this is not a legal battle – this is a “political” battle, a philosophical battle. There really is no other explanation for the Court to maintain their fingers in the patent pie.

    But why the philosophical battle? Why this philosophical battle? Aren’t we, after all, merely talking about machines?

    As a fan of Asimov, I am amused at the personification of machines underlying the computer patentability battle. It appears that we are laying the Foundation of treating machines on equal terms as humanity, with patenting of machines roughly equivalent to slavery. Who owns your DNA (in a robotic sense)? Is it really an accident that a professor of biochemestry who captured the imagination of generations of people by writing about robots and their nascent evolution of “humanity”, may be setting in motion the very beliefs that he envisioned? Shades of Psychohistory…?

  • [Avatar for Eric Guttag]
    Eric Guttag
    September 2, 2011 10:36 am


    Thanks for the further comment. I share you’re dislike of Dyk’s view on patent-eligibility (and his apparent clone, Judge Bryson, also on the issue of patent-eligibility, as witnessed in the AMP v. USPTO case). My scorn of certain members of the judiciary isn’t limited to SCOTUS.

  • [Avatar for Just visiting]
    Just visiting
    September 2, 2011 10:21 am


    Don’t get me wrong, if I said prayers at night, prayer’s for Radar’s and Newman’s good health would lead the way. I understand that we have bad case law to deal with, which is why claim language is they way it is, but claim language is still important, which was my biggest point.

    What is REALLY dislike is Dyk, in Cybersource, picking apart the method claim because it lacks the magic words that Dyk was looking for, but when it comes to the Beaurgard claim, Dyk blithely ignores all the magic words contained therein. This two-faced treatment of the claim language makes my life much more difficult.

  • [Avatar for Eric Guttag]
    Eric Guttag
    September 2, 2011 09:56 am

    “I believe Radar got it wrong when he bemoaned the clever claim drafting that takes place to circumvent eligibility restrictions.”

    JV, I think we should we should give the Chief Judge a little slack here. I think Rader was more directing his comments to the fact that current patent-eligibility precedent forces us claims’ drafters to resort to convoluted phrasing to avoid the impediments created by unwise case law precedent (Gottschalk v. Benson, In re Bilski/Bilsk v. Kappos, and the particularly inane opinion by former Justice Stevens in Parker v. Flook come to mind). As I said above, we need to simply sweep away the nonsense that has led to Bearegard claims (Gottschalk v. Benson) “post-solution activity” can’t help (Parker v. Flook), the “machine or transformation only” test (Federal Circuit en banc opinion in Bilski), “we know abstractness when we see it even if we can’t define it” (Bilski v. Kappos), etc., and rely solely on the objective “tangible, concrete, and useful result” test if we’re ever to escape this patent-eligibility “hell.”

  • [Avatar for Just visiting]
    Just visiting
    September 2, 2011 09:32 am

    For all that I support Radar and Newman, I believe Radar got it wrong when he bemoaned the clever claim drafting that takes place to circumvent eligibility restrictions.

    Claim drafting is important because the importance of the words in a claim should not be minimized. The words are what takes a claim from unpatentable subject matter to claiming a machine, process, etc. However, the problem I do have is when the Federal Circuit ignores those words (e.g., as a post-solution activity). If I recite in a preamble “[a] computer-implemented process, comprising …” I expect the following: (i) the claims are limited to be performed by a computer and (ii) in so doing, the claim is clearly tied to a machine (i.e., not an abstract idea) and is patentable subject matter under 35 USC 101.

    Another problem I’ve seen (and I’ve seen at least one commentator make this point before) is that the Supreme Court jurisprudence on this issue is awful. From what SCOTUS has written in the past, there is no reliable definition of what constitutes a claim for an abstract idea. What would help is if they actually gave us some juriprudence as to what we can reliably claim that will pass muster under 35 USC 101 (i.e., some type of safe harbor).

  • [Avatar for Just visiting]
    Just visiting
    September 2, 2011 09:14 am

    Classen doesn’t mean much when you have decisions like Cybersource Corporation v. Retail Decisions that indicate that there is a clear split at the Federal Circuit and whether or not your claims are directed to patentable subject matter depends upon whether you get Radar/Newman on your panel or Linn/Dyk.

    I made this point on PO, but nobody picked up on it, Dyk distinguished their decision in Cybersource from Research Corp. based upon the following analysis:

    “Because the method required the manipulation of computer data structures (e.g., the pixels of a digital image and a two-dimensional array known as a mask) and the output of a modified computer data structure (a halftoned digital image), the method could not, as a practical matter, be performed entirely in a human’s mind.”

    This decision recognized that most computer-implemented processes could be performed in the human mind. It might take a dreadfully long time, but it is possible. However, Dyk gets around this by asserting that the method of Research Corp could not “as a practical matter” be performed entirely in one’s head. This is one fine line.

    What kind of evidence is necessary to establish how practical it is to perform a method in one’s head? Does the determination depend upon only a single instance of the method being practiced or how the method is practiced in reality?

    Regardless, the Federal Circuit has lost its way in that they can no longer be relied upon to set precedent that other members of the Federal Circuit will rely upon. If Classen is heard again before Dyk and Lin, I have no doubt that they would uphold the rejection of the same claims under 35 USC 101.

    Until the Supreme Court gets its act together and set forths some clear guidelines as to what constitutes being tied to a machine or a transformation (in the context of methods) or what constitutes an abstract idea, we’ll be dealing with this mess for years to come.

  • [Avatar for step back]
    step back
    September 2, 2011 08:29 am


    As I’ve written at that “other” patent site (PO) there are definitely (or should I say “indefinitely”?) many other problems with the Classen claims as written, including overbreadth.

    However, the issue here under the rubric of 101 alone is whether one can perform the entire thing purely and 100% inside of one’s mind without ever resorting to things that appear in the physical, “nonabstract” world; things like two sets of mammalian test subjects and physically subjecting them to real immunization protocols (schedules) and really, rather than abstractly, determining if and to what extent each acquires chronic disorders.

    It seems to me, with due respect, that our judges talk about “abstractness” in the abstract but do not actually apply a true “abstractness” test when confronted with real claims. If they did, 101 would not even be an issue for any of the Classen claims.

  • [Avatar for Eric Guttag]
    Eric Guttag
    September 2, 2011 07:11 am


    Defintely look at my brother Mark’s additional comments and you’ll understand what the issue is with the claims in the ‘283 patent. As Mark says, the claims fo the ‘283 patent provide no result; that’s at least one aspect what is meant by “abstractness.” In fact, having a “result” for a process/method claim almost leaps out from the requirement in 35 USC 101 that the invention be “useful.” Judge Newman was certainly conscious of that (see my “kernel of truth” above).

    Frankly, we would all be better of if the courts (and especially SCOTUS) would simply dump all the malarkey (that’s my late uncle’s expression for nonsense) in Gottshalk v. Benson, Parker v. Flook and especially Bilski v. Kappos, and resurrect the objective “tangible, concrete, and useful result” test as I suggest above. Again, other tests/standards pale to subjectiveness compared to the TCU test for judging what is and what is not “abstract.”

    Hope my additional thoughts help, thanks for your comment.

  • [Avatar for Mark Guttag]
    Mark Guttag
    September 1, 2011 06:59 pm

    My main issue with the claims of the ‘739 patent and the ‘283 patent is that they are poorly drafted.

    As Eric notes in his article step (1)(b) of Claim 1 of the ‘739 patent includes the phrase “may be identified” as opposed to “is identified.” Because of the use of this phrase, it is possible that this claim could cover the situation where someone immunizes a subject with the lower risk schedule without properly identifying the lower risk schedule in the comparison step, i.e., strictly speaking, all the ‘739 patent requires in step (I)(b) is that a comparison be made, where the lower risk schedule is identified or not, and all that the ‘739 patent requires in step (II) is that the lower risk schedule be used.

    With respect to Claim 1 of the 283’s patent, the “comparing step” produces no result, and, no action is further step is taken based on the comparing step. Therefore, I think there is a significant 35 USC 101 problem with respect to Claim 1 of the ‘283. Consider the following cases with respect to Claim 1 of the ‘283 patent: Case 1 – A person immunizes mammals as indicated in the claim and then views the results of the immunizations, possibly fulfilling the “comparing step” and thereby possibly infringing the claim. Case 2 – Even weirder, a first person immunizes mammals as indicated in the claim but second person reviews the results and publishes a paper on the results. 10 years later, the the person how immunized the mammals reads the paper, thereby fulfilling the “comparing step” of the claim and possibly infringing the claim.

    Whatever 35 USC 101 is supposed to cover, I don’t think it is supposed to cover a method that could potentially be infringed by the actions set forth in Example 2 above.

    It is of serious concern to me that Judge Moore could not see this problem that is present in Claim 1 of the ‘283 patent but is not present in claim 1 the ‘739 patent. I’m not saying that Claim 1 of the ‘739 patent is a great claim, but at least in the ‘739 patent if you change “may be” to “is”, something is done in step (II) with the results of its “comparing step,” i.e., step (I)(b).

  • [Avatar for step back]
    step back
    September 1, 2011 06:16 pm

    I don’t sense how one can, purely with their mind and nothing else (meaning their eyes are closed and their ears are shut) carry out the method that requires acquiring the knowledge about the test results on the two classes of non-abstract mammalians and how that knowledge can be obtained without carrying out real world physical tests.

    Yet even the pro-inventor, Judge Newman found that claim to be totally “abstract”.

    Maybe abstractness isn’t what it used to be?

  • [Avatar for Eric Guttag]
    Eric Guttag
    September 1, 2011 04:16 pm


    I hear you about trying to decrease (rather than increase) the cost and complexity of litigation. But using patent-eligibility under 35 USC 101 is normally not the best way to reduce cost or complexity, and it certainly doesn’t lend its to any consistency in rulings (which will only make the cost/complexity worse). Until the courts adopt (or as I would call it readopt) the objective “tangible, concrete, and useful result” test for patent-eligibility that was dumped by the en banc Federal Circuit in Bilski, we’ll have a “crap shoot” on this quesiton which simply leads to inconsistent results, chaos, and more cost/complexity in litigation. That’s not any way to run our legal system, no matter what interest you represent (unless you happen to be a litigator which I, by the way, am not).

    Indeed, what the district court did in Classen is also a classical example of pulling the summary judgment trigger too quickly and without a good factural record. (I’m of the view that many summary judgment grants are driven by overworked district court judges who are trying to find a way to manage their dockets and this is one easy way to get a case off their docket.) As a result, not only have there been two Federal Circuit opinions in this case (due to an intervening SCOTUS vacate/remand/reconsider), but we’ve got what former Chief Judge Michel disliked intensely (and I agree with his dislike), namely “piecemeal/fractured” litigation” It does the litigants (as well as the courts) no good to have such “piecemeal/fractured ” litigation, and it definitely drives up the cost.

    But thank you for your comment, I do welcome opposing views.

  • [Avatar for Mike]
    September 1, 2011 03:27 pm

    I’ve taken to saying two things. First, invalidity under Sec. 101 is a lot like pornography; you know it when you see it. Second, courts (and accused infringers) are seeking some tool that expeditiously sums up an invalidity opinion for patent claims that appear to fail under 102, 103, and 112. Providing them a hammer, like 101, could decrease (rather than decrease) the complexity for everyone that would otherwise be required through costly, time-consuming and expensive litigation of claims and theories that require drawn out “factual” fights. The fact that it’s hard to put what is subject matter eligible in an objective test does not mean that we should let them “in the door,” as it were.

    The patents in Classen and Bilski are good examples. They should definitely give pause to everyone contemplating the policies underpinning the patent laws.

    Last point: the artful claim drafting issue is really a red herring. In reality, everything about patents involves artful claim drafting. But the reality is, we should be seeking to view a claims substance over its form anyway. Beauregard claims are a good example. If the underlying process was invalid, why is putting it on a disk? Or doing it with pen and paper?

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