Federal Circuit Invalidates Immunization Patent for lack of Patentable Subject Matter

Classen Immunotherapies v. Biogen IDEC (Fed. Cir. 2008)(Nonprecedential)

Judge Moore penned the one-paragraph Classen decision:

“In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court’s grant of summary judgment that these claims are invalid under 35 U.S.C. § 101. Dr. Classen’s claims are neither “tied to a particular machine or apparatus” nor do they “transform[] a particular article into a different state or thing.” Bilski, 545 F.3d at 954. Therefore we affirm.”

Classen’s claims focus on several methods for evaluating vaccine immunization schedules. Claim 1 of patent 5,723,283 is reproduced below:

  1. A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises:

    immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and

    comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

The claims here are quite similar to those addressed in the ill-fated Metabolite Supreme Court case. That case was dismissed by the court prior to reaching a final decision based on procedural failures.

The question left in my mind is how the step of “immunizing mammals” is properly disqualified.

Notes:

  • The panel consisted of Federal Circuit Judges Newman and Moore and District Court Judge Farnan sitting by designation from Delaware. Judge Farnan is a highly experienced patent law judge. The short opinion may well be the only consensus reached amongst the panel. I suspect that Judge Newman would write a much different “full” opinion on the case than would Judge Moore.
  • The accused infringers here include Biogen IDEC, GlaxoSmithKline, Merck & Co, Chiron, and others. I am surprised that these companies – which rely heavily on treatment method patents – would have argued strongly that the “immunizing” step was not sufficient to overcome

About Dennis Crouch

Law Professor at the University of Missouri School of Law. Co-director of the Center for Intellectual Property and Entrepreneurship.

95 thoughts on “Federal Circuit Invalidates Immunization Patent for lack of Patentable Subject Matter

  1. In the old days, before Bankstreet, such a claim would have been patentable because of the physical step of immunizing. An immunized animal is different from a non- immunized one. Its altered. Is Bilski so broad as to say its not? Or are they looking at something else, like the preamble. As stated it sounds fuzzy. Could they have prevailed by saying “A method of immunizing animals comprising the steps of…”?

  2. What is the invention? The invention is for updating an abstraction called a schedule. This claim is analogous to the Parker v. Flook claims of updating an alarm limit. The first step are nothing more than “data gathering” steps needed to modify or update the schedule.

  3. The claim as a whole needs to transform something. That a transformation occurs in one step of a multistep invention is irrelevant. In a method of treatment invention, the final result is a patient with improved health. What is the final result of carrying out Classen’s invention?

  4. “”Preambles should be construed as limiting ALWAYS and in EVERY CASE (and someday this will become the law because the current state of the law is extremely silly).”

    I’m going to respectfully disagree here. As you know, current US practises disregard the preamble unless “life and vitality” (whatever this means) is breathed into the preamble by the body.

    If I want the preamble to be limiting, I would stick the limitations in the body of the claim. Leaving the preamble interpretation the way it is leaves more wiggle room in favour of the applicant.

    What do you think?

  5. “MPEP requires PTO examiners to conduct an art search BEFORE they resolve 101 patentable subject matter issues.”

    I believe the reason for searching prior to performing a 101 analysis is to survey the prior art. As claim interpretation is performed before the 101 analysis, surveying the prior art would also contribute to the interpretation of the claim.

    Thoughts?

  6. Malcolm I h_te to be blogging on Dec 25, but thought I should answer your Newman/EPO question.

    Art 52 EPC test is whether the claim has “technical character”. Laugh if you like but we in Europe think that patentable subject matter is confined to fields of technology. So, ask 1) does the claimed subject matter have technical character 2. Is it old 3. Is it obvious 4. Is it industrially applicable 5. Is it clearly claimed, and 6. Is it enabled (in the app as filed)? It is the flow of a thousand EPO TBA (Technical(sic) Board of Appeal) Decisions per year, none appealable, that gives the EPO “technical” test its legal certainty, however much Aharonian might scoff. Your ball. Switching off now.

  7. Actual Idgit “Lastly, the last step being a mental process is largely irrelevant to the 101 process as you must evaluate the claims as a whole…”

    LOL. First of all, you’re full of crap re what Diehr “requires”. Second of all, if you actually read the claim as a whole, it’s a method for “determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals.”

    Yet, one can plainly practice each step in this claim without yielding any such “determination”. The claim fails to deliver. It fails to deliver because the promised transformation of information never occurs. Some other transformations occur, but they are as irrelevant to the 101 issue as a limitation reciting a step of “breathing air.”

    Merry Xmas, dumbaxx.

  8. “Just because there is a limitation within the claim that meets 101, doesn’t make the entire claim comply with 101. Here is an example:
    1.) A method, comprising:
using a coffee machine to brew coffee (tied to a particular machine);
pouring said coffee into a cup (a transformation); and
comparing a color of said coffee with a color of said cup.
    Now, does this claim meet the requirements of 101 solely because it is tied to a particular machine and/or transformation (a coffee maker and the transfer of coffee)? Or is the last step essentially damning, since it is NOT tied to a particular machine/transformation and can merely be performed by a mental process? I lean toward the latter.
    Posted by: Random IP guy | Dec 20, 2008 at 02:54 PM”

    Mr. IP Guy
    Actually you set up a nice straw man here. Your example of a coffee machine, as a particular machine to which the claim is tied, is not at all valid. Why? Simply because you can brew coffee with or without a coffee machine which leaves the claims to succeed or fail on the transformation test. In the latter you would need to claim a new method for brewing coffee which is tied to the mixing of substances, which is your transformation. That would be statutory.
    Lastly, the last step being a mental process is largely irrelevant to the 101 process as you must evaluate the claims as a whole, as I taught Mr Malcom earlier. If those claims are tied to a particular machine or transform a particular article into a different state or thing the claims are statutory, even if one or more of the steps can be performed entirely in the mind. I suggest going to the Diehr case.

  9. “Maybe if they added the word “syringe”, that would have sufficed.
    Posted by: GP | Dec 20, 2008 at 11:44 AM”

    Actually there is no reason to add the word “syringe” because it is inherent that an apparatus is required to administer the immunization. This line of reasoning was proffered by the CAFC and accepted by the PTO during the Bilksi arguments “pre-enbanc”.
    I paraphrase, “One of the CAFC judges asked Raymond Chen, the Assistant Solicitor General, arguing for the government, If a new method for removing the appendicectomy was invented and no machine or apparatus was described in the claims, would the claims be statutory under 101. Chen replied, yes, because in that situation the apparatus would be inherent.”

    So unless there is some way of administering an immunization without any apparatus whatsoever, i.e.needle, syringe, etc. this claim is clearly statutory because it’s tied to a particular machine or apparatus.

    Actual Inventor

  10. “The problem in Classen (at least with respect to the claim at issue) is that it is pure crap. Immunizing mammals = old. Comparing immunized mammals to non-immunized mammals = old. Dosing immunized mammals according to a schedule = old.

    There must have been some serious strict-TSM wanking going on during the prosecution of that claim. It’s really quite sickening. Good riddance.

    Posted by: Malcolm Mooney | Dec 19, 2008 at 02:18 PM”

    Mr. Malcolm:

    Did you evaluated the claims as a whole as is required by law, or did you just break down each element into what you consider old and new parts. Malcolm, you are not allow to do the latter. There is a supreme court case called Deihr that you should read that explains why you are wrong. Bilski also makes reference to that case as well.

    Also, why are you arguing that an invention has to be new? The statue allows for a patent on a new use of a known process or machine. Again you have to take the claims as a whole when making that determination.

    Actual Inventor

  11. MD “Newman and the EPO are at one. One sets the art to one side when considering Art 52 EPC.”

    C’mon MD. There are too many differences between the two systems to equate Newman’s opinion with some rule at the EP. The caveat’s are huge.

    For instance, can I put a step of “breathing air” into a claim that doesn’t meet 52 EPC and claim and sail through? Because the EPO isn’t allowed to consider the fact that “breathing air” is old, correct?

    What does the EPO do with claim preambles?

  12. Max, while we’re waiting for Moonbeam, let me offer a patent reform proposal. I couldn’t agree more that a “101 search” is inane, but MPEP requires PTO examiners to conduct an art search BEFORE they resolve 101 patentable subject matter issues. I believe this is part of the mis-guided “compact prosecution” policy, which is essentially mythical anyway.

    It seems that a better approach is a 2 level prosecution. Level I, the examiner analyzes the claims and disclosure for compliance with 101, 112, and any other non-art issues. No search.

    If there is a Level I rejection, the applicant has one chance to amend or traverse. Most of these rejections are easily made and easily overcome. If the applicant refuses or fails to amend/traverse, the second rejection is final and the appeal process kicks in. Optionally, if the supervisor thinks the appeal may be close, he/she may stay the Level I appeal and direct a Level II examination on the art — ie, back to compact prosecution.

    If the application passes Level I, the PTO conducts a search and does a Level II examination under 102 and 103, and the current 2 rejections and you’re crisp system plays itself out as it does now.

    So some applications with art and not-art problems could get as many as 4 rejections — 2 at each level. And in some cases, there could be 2 appeals if a Level I appeal succeeds and then an appeal Level II rejections is filed.

    But other applications are going to be dead in the water at the end of Level I examination [which only takes about 20 minutes], so an enormous amount of time is saved by avoiding the search on applications that are non-patentable for non-art reasons.

    BPAI could be divided into Level I and Level II panels that specialize in non-art and art issues in order to facilitate appeals and standardize outcomes. CAFC, too, ideally.

    I’m just trying to get to a system that doesn’t waste time searching the art and fighting over art rejections for the applications that can be expeditiously dealt with much more quickly under 101 and 112.

  13. Malcolm Mooney, I am intrigued by your statement that Newman is wrong to set the state of the art to one side, when she is considering compliance with 101. In the EPO, the same debate has raged for many years, but now it’s settled. Newman and the EPO are at one. One sets the art to one side when considering Art 52 EPC.

    That’s because Art 52 deals with inherent or absolute patentability whereas 54 and 56 (our 102 and 103) deal with it relative to the art. It is hard enough to get a PTO search done in reasonable time, that addresses all novelty issues, and obviousness. Burdening the searcher with doing a “101 search” is inefficient. Arguing 101 wrt the search references will disturb the harmonious relationship between Exr and atty. That’s me done. Now, to save me reading the whole thread, will you tell me, in a nutshell, why Newman (and Europe) have come to the wrong conclusion?

  14. I agree with Jim and others above.

    Terrible claim drafting, I agree (if only for the repeated and lame use of “or” throughout.) And one would HAVE to read the preamble as a limitation to breathe any meaning into the claim at all, as posted upthread. (Plus, there is a need for antecedent basis for “chronic-immune mediated disorder.”)

    So what method is being claimed? Not immunization – surely a transformation. It seems the patentee is claiming how to determine if an immunization schedule is effective. However, the method does not claim how such a determination is reached – merely requiring that two things be compared, but no limitation requires that a conclusion be drawn. (Further, what is required to be compared, and to what, is an indefinite mess, it seems to me.)

    Regarding Bilski, nothing is transformed because the method starts with a question it leaves unresolved. No limitation as to how to determine an answer to the question of the preamble, in this claim, means an answer = no transformation. IMHO

  15. Babel boy says “But the answer to your query is clearly: the presence of a mental step (comparing the colors) does not render an otherwise eligible process claim un-patentable subject matter under 101.”

    I agree.

  16. babel boy “But the answer to your query is clearly: the presence of a mental step (comparing the colors) does not render an otherwise eligible process claim un-patentable subject matter under 101.”

    Indeed, that’s old and well-understood.

    The claim at issue here is a claim to mental invention (“determining by comparing”), after you ignore the trivial non-mental and non-inventive step. It is not patentable subject matter. It’s also obvious and non-enabled.

    Take your pick. Do I care? No. The question is: why do someone people care so deeply? The answer is that Beauregard claims are going down and software prosecutors are flipping out, grasping at straws, and attacking the PTO and the CAFC for taking away a magical gift they never deserved.

    “What is known in the art is irrelevant to 101, as Newman keeps reminding us”

    Newman is wrong.

  17. Randy IP guy

    My position would be that so long as you have a single transformation step that meets the Bilski test, it makes no difference what other limitations or steps you have in the claim — the claim will constitute patentable subject matter under 101.

    I would also take this opportunity to pick this semantic nit: A claim does or does not constitute patentable subject matter under 101, but no claim is “patentable” under 101. There is a distinction. Of course, if a claim does not constitute patentable subject matter, then it is per se not patentable. Full stop. But if it does constitute patentable subject matter, 101 does not render teh claim patentable. Nor is a claim “patentable under” 102 or 103. It may be novel under 102 and non-obvious under 103, but that does not make it patentable. However, a claim may be UN-patentable under 101, 102, 103. The lack of symmetry is confusing, but it’s a “neccessary-and-sufficient” kind of analysis.

    Your hypo: Would a step of adding cream and sugar to coffee render a claim patentable subject matter under 101, you ask. You betcha’, if the step of adding cream and sugar is central to the purpose of the claim.

    But adding cream and sugar is known in the art of drinking coffee you (and Moonbeam) will protest — how could that step render the claim patentable subject matter? What is known in the art is irrelevant to 101, as Newman keeps reminding us.

    I am not sure what you mean by the step is merely performed by a mental process. You don’t mean adding the cream, you mean comparing the colors.

    When people say “you can’t patent a mental process” that does not mean that a mental process step may not be part of a valid claim. IOW, having a mental step in a claim does not necessarily render the claim non-patentable subject matter.

    Here’s the way MPEP 2106 puts it:

    “While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting, methods and products employing abstract ideas, natural phenomena, and laws of nature to perform a real-world function may well be.”

    There is recent CAFC case law on this, but I’ll let you dig it out. In fact, I believe Michel made this point explicitly in Bilski.

    But the answer to your query is clearly: the presence of a mental step (comparing the colors) does not render an otherwise eligible process claim un-patentable subject matter under 101.

  18. Did I miss the part where either the District Court or the CAFC specified which patents and which claims were invalid? I could be looking at the wrong Dist Ct disposition, but mine has only a discussion of the sanctions and motions to dismiss. No summary judgment of invalidity and no mention of the patents involved in the decision other than the first paragraph listing all four Classen patents. I’m looking at 381 F. Supp. 2d 452.

    I agree that all the claims are pretty poor, but Claim 1 in the 5,728,385 patent (below) is better and closer to patentable subject matter than the obvious research plans of the 6,420,139 and 6,638,739 patents. This claim recites active physical steps involving at least as much of a transformation as reporting.

    1. A method of immunizing a mammal less than 96 months of age against at least one infectious disease, while decreasing the incidence of an autoimmune disease, comprising

    administering to said mammal one or more pharmaceutically acceptable pharmaceutical preparations, comprising one or more immunogens, according to an immunization schedule according to which, at specific times after birth, the mammal receives one or more pharmaceutically acceptable doses of one or more immunogens;

    said mammal thereby receiving, for each said infectious disease, a suitable immmogen in such amounts, given at such ages, as to be effective to substantially prevent or substantially reduce the severity of such infectious disease;

    said administering further resulting in an immune response in said mammal sufficient to substantially reduce the incidence of an autoimmune disease in such mammals;

    said mammals are selected from the group consisting of humans, and nonhuman mammals which are animal models of a human autoimmune disease,

    the first dose of said immunization schedule being administered when the mammal is less than 42 days old, measured from birth,

    where, if only one immunogen is administered according to said immunization schedule, that immunogen is one other than BCG,

    where, when all of the immunogens administered are selected from the group consisting of BCG, diphtheria, tetanus, whole cell pertussis, polio, hepatitis B, hemophilus influenza, measles, mumps and rubella immunogens, at least one of the following conditions applies: (a) immunogens are administered on at least three different dates prior to 42 days after birth, or (b) immunogens are administered on at least three different dates, and the maximum interval between administrations is about two weeks, or less,

    where said autoimmune disease is selected from the group consisting of diabetes mellitis and systemic lupus erythrematosis.

  19. “however, I’m analyzing the claim on a step by step basis.”

    Random IP guy,

    I believe therein lies the issue…

  20. In the USA, is the expression “He’s not the genuine article” ever heard? If so, then I guess a member of the human race is an article. Besides, farmed mammals are articles of commerce, right, and I suspect many of them are full of antibiotics, put there by penny-pinching husbandmen, who over the years have analysed the results, relative to animals not so immunised, and have come to think the expense of such immunisation is worthwhile.

  21. “Right you are, Randy. But you are missing the point, too. Limitations do not “meet” or fail to “meet” 101 — claims do. However, in our brave new world under Bilski, having a transformation step in the claim may be sufficient to render the claim patentable subject matter, if that step is central to the purpose of the claim.”

    I understand that claims “meet 101”, however, I’m analyzing the claim on a step by step basis. Does a limitation within the claim that does not meet the requirements of 101 automatically render the claim unpatentable? Another example would be steps 1-3 are tied to a particular machine or transformation. Step 4 is an abstract idea, tied to steps 1-3. Is the claim now unpatentable due to the use of the abstract idea?

    “The answer to your hypothetical is — no, the claim is not patentable subject matter under 101. And that is because 1) nothing is transformed in your “transformation” step, and 2) even if the cup were deemed transformed, the transformation is not central to the purpose of the claim — obviously one can compare the colors regardless of where the coffee is. One need not fill a cup to compare the color of the coffee in it.”

    Ok, let’s change it up a bit. Step 2 is “adding sugar and cream to said coffee”. One can argue that the chemical transformation thus alters the color of the coffee. Is this claim patentable under 101 merely because a transformation (adding sugar and cream to coffee) takes place, even in the presence of a limitation that is not necessarily tied to the transformation/machine and can merely be performed by a mental process?

    “You are getting lost in obviousness, too, Randy. Forget Moonbeam, he’s in his own obviousness-limited universe.”

    No, I haven’t mentioned whether my example meets the requirements of 102 or 103 (obviously it wouldn’t), and merely thought up the example after pouring my own cup of joe 😉

  22. “”The burden is not on the applicant to demonstrate that his application is allowable”

    That has been held for far too long. It is probably counter to statute.”

    I think examiner 6 has a problem with the statutory scheme. 35 U.S.C. 102 states in relevant part, “A person SHALL be entitled to a patent unless–[setting forth conditions].” (Emphasis added.) And this section immediately follows 35 U.S.C. 101, which states that the applicant “may obtain a patent therefor, SUBJECT TO the conditions and requirements of this title.” (Emphasis added.)

    I think there is sufficient statutory support for the long established procedure which places the burden on the USPTO to show that the applicant is NOT entitled to a patent, etc.

  23. geeeno,

    What do you think “article” means?

    I’m pretty sure we can eliminate apparatus and machine on face value…

  24. am i misunderstanding something about these comments? has it been established that a mammal is an apparatus, machine, or article?

  25. “The burden is not on the applicant to demonstrate that his application is allowable”

    That has been held for far too long. It is probably counter to statute. The applicant is the only one in charge of making sure that the application appears to be entitled to a patent on examination. It thus goes without saying that the burden of presenting an application which appears entitled to a patent rests squarely upon his shoulders.

    I should add, whether or not he is inclined to demonstrate such is entitled to a patent is up to him. Applicants regularly decline to do this, and have paid the price in recent years. Fine with us.

  26. Stein: “its dismissal without explanation”

    Except they did explain it, David. And I prosecute in the field and I don’t have a problem with the dismissal or the explanation.

    I wonder what your angle is. Maybe you just dislike trees?

  27. “What is patentable here in the claim?”

    The burden is not on the applicant to demonstrate that his application is allowable. The burden is on the examiner to demonstrate that it’s NOT, using one of the several tests of unpatentable subject matter. That’s how it’s been since the birth of the modern Patent Act (1952, 1836, etc.)

    The CAFC’s opinion upends this procedure. its dismissal without explanation – in one of the very first CAFC cases to apply Bilski – suggests that “Bilski” is simply a magic word that the CAFC (and by extension, lower courts, the BPAI, examiners, etc.) can invoke to shift the burden to the applicant.

    That, in and of itself, is groundbreaking.

    – David Stein

  28. For those who like to play games, here’s a fun brainbuster: let’s say you have a novel method of immunization comprising a step of administering an effective does of your novel vaccine to said mammal.

    In claim 2, you recite a dependent claim as follows: “The method of claim, wherein after said administration, the response of the animal to antigen challenge is compared with a control.”

    Claim 2 is unpatentable under 101.

    Is claim 1 therefore unpatentable under 101 because it necessarily includes claim 2 within its scope?

    [cue up Beethoven’s 5th]

  29. Babel Boy “I have absolutely no problem seeing that a goat that has been injected with an antigen + hapten, etc. to induce antibody production has been transformed.”

    And hey! even if the claim only recited a step of “determining the results of an experiment by comparing the experiment with a control,” it’d still meet 101 because anyone who compares something is inherently breathing air, which transforms oxygen into water and CO2! Nobody can tell me that’s not a tangible transformation!

    /Babel Boy mindless rambling off

  30. What is patentable here in the claim?

    Isn’t it claims something that everyone in the industry uses – virtually everytime when efficacy of molecules, whether new or old, on a test system needs to be determined?

  31. We hear ya’, noise above — oh, boy do we hear ya’

    Anastasia goes to work on the real intellectual challenge in deciphering Moore’s “opinion.” What the blink is “transformed” or a “new thing”?

    I cannot agree that different thing refers only to a change of state of matter. But — hey — who knows what en banc was thinking? They sure didn’t tell anyone.

    There used to be the concept of the “work piece” which was, as I understood it, the entity that was changed by a claimed process. I don’t even know if there is any 21st century patent law using the term or concept.

    When the process was a new way to attach spokes to a hub or a new way to shoe the mule, the work piece and how it was transformed was pretty clear — hub, hoof. But moving into the 21st century, which the CAFC hasn’t yet done, the whole thing begins to blur because the “work piece” is either not tangible or is not a single entity. As Anastasia sort of suggests, what’s the work piece in an immunology claim? Or a software claim?

    What the CAFC should have done in Bilski is to say, OK, “work piece” won’t work on a lot of this new subject matter so here’s the game plan … and lay it out so we could see how process analysis now works viz a viz the “old” way of analyzing process claims. But they’ve just mushed it all together and made an amorphous mess of it.

    As far as the immunological example presented by Classen, I’m not an immunologist, but I’ve got a PhD in the medical sciences and I have absolutely no problem seeing that a goat that has been injected with an antigen + hapten, etc. to induce antibody production has been transformed. But is the goat a work-piece? I dunno’. How about the control goats injected with just the hapten? Who knows? That’s what US taxpayers are paying Newman and Moore $200K a year to tell us. And, obviously, they’re not doing it.

    Think I’ll limit my practice to mule shoeing processes until they get this Bilski mess straightened out. Anybody know what art group that is?

  32. Once again, Malcolm cannot distinguish between 101 and 103. Prior art has nothing to do with 101 Malcolm.

    I do agree that for 101 this claim should have had a third “application” step where they applied whatever information was gleaned to do something. It would probably still be rejected under 102 for lacking novelty.

  33. Leopold Bloom wrote:

    “Ignoring the loaded terms ‘anti-patentee’ and ‘pro-patentee’, and assuming that you mean ‘holdings in favor of the patentee’ and ‘holdings in favor of the non-patentee’…”

    No, that’s not what I mean. Frankly, I don’t care who wins any particular case – I’m not a litigator.

    I’m referring to changes to the law and procedure of patenting and patent enforcement. “Pro-patentee” cases are those that make prosecution easier, expand the scope of patentable subject matter and claim styles, reduce delay or expense in prep/pros, and strengthen enforcement. “Anti-patentee” cases are those that do the opposite.

    To be clear – I’m not a laissez-faire advocate here; I don’t think every “pro-patentee” decision is good or sound. There’s a lot of wisdom in patent misuse principles, and I applaud both the MedImmune and eBay cases (both “anti-patentee.”)

    ===

    “…would this statistic really mean anything?”

    Of course it would. A sweeping set of changes that steadily shift the law in a particular direction is always relevant.

    My point is that the rule changes by the USPTO, and the case law released by the CAFC over the past decade, has made patent procurement and enforcement significantly more difficult, expensive, lengthy, and speculative. We can debate whether or not this trend is wise and good – but the fact of the trend is simply beyond dispute.

    ===

    “It seems to me there’s something of a selection bias – i.e., that a large portion of patents that are litigated all the way to the CAFC are dubious.”

    If the CAFC had simply applied the law in a static form, and had thereby rejected 90% of patents brought before it through a straightforward application of the law, I wouldn’t care.

    I’m not basing my opinions on how patents have fared. I’m basing my opinions on how the law of patenting and patent enforcement has changed. And it has changed a lot in the last decade… most of it in ways disadvantageous to the applicant or patentee. Bilski is not merely a return to the pre-State Street days – it is a retreat past Freeman-Walter-Abele, all the way back to Diamond v. Diehr… when computing was still in the stone age.

    ===

    “It seems a bit premature (and professionally irresponsible?) to suggest that the CAFC, or anyone on it, is ‘anti-patentee,’ simply because part of their responsibility is to make rulings that are adverse to patent owners.”

    But again, I’m not commenting on a invalidation or non-infringement of any particular patent. I’m commenting on the changing relationship of the body of patent law – driven by the CAFC and the USPTO – with the patentee. And I stand by my comment that most of those changes are anti-patentee.

    – David Stein

  34. ” . . . as a change back to an initial state is still a change. In fact, the immunizing and determining are both directed to the various changes in state (along the continuum of pathogen free – pathogen – pathogen with natural antibody response – pathogen with augmented antibody response – pathogen free)”

    I think the Fed’s decision is premised on the fact that there is no transformation into “a different state OR THING”. Obviously, the CAFC didn’t find that the immunized mammal is a “differnt THING” (I read “state” to be a state of matter, i.e. solid, liquid, gas). Thus, an “immunized mammal” is *different* relative to the non-immunized mammal, but it is not a different *thing*, i.e. the immunized mammal is still a mammal – the immunized mammal does not “transform” into a chicken, lizard, turtle, etc upon being immunized – it is still a mammal, and thus there has been no “TRANSFORMATION of the particular article (non-immunized mammal) INTO A DIFFERENT state or THING”.

  35. Donald,

    THank you for your contribution, but you will have to do a better job of stating your position, as your distilled comments lead to a logical contradiction.

    “The mammal/article is now pathogen-free, but that’s not a “different state” if your point of reference is the time before the pathogen was introduced to the mammal/article.”
    – so, logically, the intervening changes of state do not count? – I think not, as a change back to an initial state is still a change. In fact, the immunizing and determining are both directed to the various changes in state (along the continuum of pathogen free – pathogen – pathogen with natural antibody response – pathogen with augmented antibody response – pathogen free).

    “If you assume that neither the pathogens nor the antibodies are part of the mammal/article…”
    Can the antibodies be in a state such that an immunization is not required? If the answer is “yes”, then your logic leads you to the notion that immunizations are useless – a position I doubt you hold. If the answer is “no”, then undoubtedly, a change in state has occurred.

    Further, I do not think the path you suggest will work as rationalization of the CAFC decision. Without more from the CAFC, it is not possible to rationalize and that’s why many patent people consider the CAFC to be failing to do their job. First putting Bilski out in an obvious incomplete state for fear of taking a stand on the complete matter and being reversed yet again by the Supremes, then adding to the fire by thowing a simple log when the masses are screaming for clarity from the CAFC.

    One thing the Supremes SHOULD do is blast the CAFC for again failing to do their job. To continue on the (american) football analogy I’ve used on another Patently-O thread, the CAFC is like the kicker and has again missed a field goal late in the game. While the field goal attempt is difficult, it is makeable and the fans are upset – the kicker has not performed the job he is paid to do. The Law is good, we just need to execute and perform.

  36. I can see one way to rationalize the CAFC’s decision: Immunization inherently acts to add antibodies to the mammal’s bloodstream. The antibodies act to destroy the target pathogens. If you assume that neither the pathogens nor the antibodies are part of the mammal/article – and I’m not so sure that that is biologically correct for the antibodies – then said mammal/article has not been transformed into a different thing. The mammal/article is now pathogen-free, but that’s not a “different state” if your point of reference is the time before the pathogen was introduced to the mammal/article.

    Donald L. Champagne, USPTO Primary Examiner and Visiting Scientist, Dept. of Ophthalmology, The Johns Hopkins University School of Medicine

  37. Moonbeam says

    “A step requiring “breathing air” in this claim would not turn it into a patentable claim under 101.”

    Oh? — according to Bilski if breathing air is claimed as a step for transforming O2 to CO2 and if that transformation is central to the purpose of a claimed process (maybe it’s an underwater re-breathing process), then, at least according to Michel, the claim passes the transformation test and you move on to the 102 and 103 analysis.

    What you are just not grasping, Moonbeam, is that compliance with 101 (i.e., patentable subject matter) is necessary but not sufficient for patentablity. Patents are not allowed just because the subject matter is patentable under 101. Applying 101 is only one step — and it should be an early step — in the analysis of patentability.

    Focus on Bilski and 101 and you will be able to grasp this point. Forget novelty and obviousness for the purposes of this case. Novelty and obviousness have nothing to do with this case. This case is helpful because it is a distillation of just this one, very tight legal point — the transformation test of Bilski.

    Random IP guy said

    “Just because there is a limitation within the claim that meets 101, doesn’t make the entire claim comply with 101.”

    Right you are, Randy. But you are missing the point, too. Limitations do not “meet” or fail to “meet” 101 — claims do. However, in our brave new world under Bilski, having a transformation step in the claim may be sufficient to render the claim patentable subject matter, if that step is central to the purpose of the claim.

    The answer to your hypothetical is — no, the claim is not patentable subject matter under 101. And that is because 1) nothing is transformed in your “transformation” step, and 2) even if the cup were deemed transformed, the transformation is not central to the purpose of the claim — obviously one can compare the colors regardless of where the coffee is. One need not fill a cup to compare the color of the coffee in it.

    You are getting lost in obviousness, too, Randy. Forget Moonbeam, he’s in his own obviousness-limited universe.

    Getting back to Classen, a number of us have raised the point that the immunization step is a transformation, and I opined that that transformation is central to the claimed method of comparing immunized mammals to control mammals — how else you gonna’ do it? Ergo, according to Bilski, the claim is patentable subject matter under 101.

    Moore’s opinion to the contrary is troubling, maybe because of her Moonbeam-like inability to see this simple distinction between 101 patentable subject matter and patentability. Or maybe because she is surreptitiously applying the word “particular,” which is a term raised in Bilski that nobody appears to have a clue as to the meaning of. Or it maybe because the CAFC sand-bagged these lawyers with Bilski after their briefs were filed.

    Something about this “opinion” smells not good. As I said before Bilski is making this court look like dolts en banc, and it’s only going to get worse.

  38. ” “immunizing mammals” step makes it patentable subject matter. ”

    I agree with previous commentators that this statement is absurd. Just because there is a limitation within the claim that meets 101, doesn’t make the entire claim comply with 101. Here is an example:

    1.) A method, comprising:
    using a coffee machine to brew coffee (tied to a particular machine);
    pouring said coffee into a cup (a transformation); and
    comparing a color of said coffee with a color of said cup.

    Now, does this claim meet the requirements of 101 solely because it is tied to a particular machine and/or transformation (a coffee maker and the transfer of coffee)? Or is the last step essentially damning, since it is NOT tied to a particular machine/transformation and can merely be performed by a mental process? I lean toward the latter.

  39. It would interesting to know more about the owner of the Classen patent, and the owners of the owner, who funds them, and what the hell they were thinking. I wonder if they actually managed to get money out of some naive infringer.

    PTO really screwed up when they issued this garbage. If they’re looking to fire an Examiner and his/her superviser, they should look at everybody who touched this piece of doo-doo.

  40. “An immunization is a transformation of the mammal and of it’s immune system. Full stop.”

    Breathing air is a transformation of oxygen to water and carbon dioxide. Full stop. A step requiring “breathing air” in this claim would not turn it into a patentable claim under 101.

    You can’t transform a claim from a non-statutory invention (“determining by comparing”) to a statutory invention by adding bogus non-inventive “transformation” steps. Nor can you argue that the bogus transformation steps are “inherently” present.

    Remember this, Babel Boy. Remember this or learn it the hard way. This is the third or forth time you’ve been corrected already.

  41. Moonbeam said

    “Nor does the claim recite a novel method of transforming anything. The claimed invention is not a method for immunizing mammals so, like a step of “breathing air”, that step is irrelevant to the statutory consideration under 101.”

    This is classic Moonbeam, who, for the life of him, cannot distinguish 101 rejections from art rejections. To him every rejection, and all of patent law, revolves around novelty/ obviousness. He can’t help it. He’s either senile or pretending to be.

    There may be obviousness issues with the claim at issue, but those issues have nothing to do with this decision.

    Moonbeam and others also appear to be confused as to what Michel en banc said and did not say about the transformation test — mostly did not say. No one has held that the transformation must be novel or non-obvious. Moonbeam’s “breathing oxygen” might be a perfectly proper step under Bilski analysis. There are two criteria (see Bilski, pg 24 link to cafc.uscourts.gov):

    1. The process must transform an article into a different state or thing (what the legal definition of “thing” may be, we are given no clue. Moore could have helped here, but chose not to.)

    2. The transformation must be central to the purpose of the claimed process.

    [NOTE: by this point in the opinion Michel had dropped the “particular” adjective that Moore used. As I pointed out above “particular” is its own can of worms.]

    It is impossible for any person having any skill at all — and I’m not talkin’ “ordinary” here, any de minimis skill, as in 10th grade biology, is sufficient — to read that Claim 1 and not see that both of these criteria are met.

    1. An immunization is a transformation of the mammal and of it’s immune system. Full stop. Anyone, including Moore, would be a dolt to argue otherwise.

    2. Immunizing (i.e. transforming) the mammals was central to the claimed method of comparing immunized to non-immunized. How hard is that?

    ERGO — the claim is a good 101 claim under the Bilski transformation step. QED

    [The claim is screwed under 103? Maybe. Probably. But that is not the issue here, Moonbeam. The CAFC did not rule on obviousness, so move your irrelevant obviousness opinions to another thread. Try a KSR thread.]

    My guess is that these briefs were filed pre_Bilski so counsel did not have fair opportunity to present the “proper” arguments and the CAFC simply screwed them to move its docket along.

  42. Everyone commenting should read or scan the Classen patent specification 5,723,283. It is a classic research treatise. There is no disclosure beyond vague assertions of any machine for performing either of these steps and it does not exclude human performance of both of these method steps. The immunizing step is performed by a lab technician as is conventional in the art. The comparing step can be done by a researcher using no more than a pencil and paper as is or was also conventional. Whether the animal or human subject is “transformed” by being injected is irrelevant and is certainly not disclosed; it/he is not a machine.

    Were these “means” claims, there would be no corresponding structure in the specification. And if there was corresponding structure, what was disclosed would certainly would be old in the art.

    An anticipation or obviousness analysis of the Classen claims would certainly be interesting, but we probably will not see one soon.

    The public policy issue is whether or not such claims deserve patent protection. Classen hides behind a smokescreen that studies of adverse effects of immunization are inhibited and that its noble pursuit is to uncover such adverse effects (and to patent them?). It goes even further stating that it seeks to pursue: “Method[s] to Stimulate the Discovery and Disclosure of Adverse Events through Patenting the Disclosure of Adverse Event Information.” See link to vaccines.net Does this meet the public policy goals of patent protection? Does it mean that Classen seeks to inhibit disclosures of adverse event information unless the disclosing party pays a royalty?

  43. Mr. Stein-
    “And if the CAFC had merely denied cert of this case, no one would have batted an eyelash. But here, it affirmed with a conclusory rejection under section 101 – in a case that, to many of us, seemed *clearly* to satisfy the Diehr test as described by Bilski, let alone enough to withstand summary judgment against!”

    The CAFC does not have cert discretion. That’s why the court disposes of so many cases (maybe most, I’m not sure of the numbers) with non-precedential opinions or summary affirmances. They don’t have the luxury of waiting for the only the perfectly clean cases. Every case must be disposed of somehow. I’m guessing this case was, for whatever reason, not a good platform for a big 101 decision. Get over it, I’m sure they’ll find another one.

  44. Maybe if they added the word “syringe”, that would have sufficed.

    I disliked Moore when she was first profiled in this blog.

    I dislike her moore now.

  45. “Preambles should be construed as limiting ALWAYS and in EVERY CASE (and someday this will become the law because the current state of the law is extremely silly).”

    Hear, hear! And it would also render much of Bilski unimportant. Recite “in a computer” in the preamble, and the method is statutory. If you want to keep the “preemption” analysis, fine – we’d still be in a much better situation than we are now.

  46. “I would LOVE to see a scorecard of the number of anti-patentee vs. pro-patentee opinions the CAFC has issued in the last three years. I’d put safe money on a ratio greater than 2:1.”

    Ignoring the loaded terms “anti-patentee” and “pro-patentee”, and assuming that you mean “holdings in favor of the patentee” and “holdings in favor of the non-patentee”, would this statistic really mean anything? It seems to me there’s something of a selection bias – i.e., that a large portion of patents that are litigated all the way to the CAFC are dubious. There are a couple of reasons why this might be so – many stronger patents are licensed w/out litigation; because litigation is typically much more expensive for the defendant than the patentee, all but the weakest cases settle early; etc. 0.0000000006 doesn’t get very much right, but he is correct that there are some crappy (or at least sloppy) lawyers/agents out there submitting (and sometimes getting) crappy claims.

    It seems a bit premature (and professionally irresponsible?) to suggest that the CAFC, or anyone on it, is “anti-patentee,” simply because part of their responsibility is to make rulings that are adverse to patent owners.

  47. It is no wonder after Bilski that this claim is thrown out. A “method of determining”, unless literally limited to a machine doing it, is most broadly construed to be a set of mental steps. Look at the preamble of Claim 1. If this were an optimized method of immunization of animals, that’s clearly patentable, because the gravamen of the claimed subject matter involves transformation of a substance (mammals). But it is not. The immunization could have occurred at any time (e.g., 100 years ago) before the claimed determination was made. The CAFC got it right applying Bilski this way.

    Malcolm Mooney has already made this point much better than me in this blog, but if you want some more reading on this type of litigation, go to the European case law. A mental process has been unpatentable there since the EPC was enacted. The US has now gotten to the point that Europe has been at for some time now.

  48. Malcom . . . the Fifth Amendment prohibits reversal of the Beauregard claims. It was settlement with the USPTO. I think it will take SCOTUS to speak on that. Were their a reversal that would clear be a Due Process violation.

  49. Well I am happy that the judges are earning their pay. I mean if you are gonna invalidate patents at least throw some academia at it. I was really getting depressed at the hangin-the-prosecutor-out-to-dry tactics. Firstly, it seemed like they were making things up as they go along to find rule 1.56 violations. I mean some of the stuff they came up with was quite baffling. With section 101, however, it seems a little more fair. At least they have to spin some legal theory to support their position. That stuff with Rule 1. 56 it took them what, 8 years to decide what test to apply.

  50. anonymous: Thanks for your reply. I’m due to review some of the older cases, anyway, so I’ll accept your interpretation of these cases (until then 😉 ) … hope we can take up the issue again another day.

    – David Stein

  51. david “here, it affirmed with a conclusory rejection under section 101 – in a case that, to many of us, seemed *clearly* to satisfy the Diehr test as described by Bilski, let alone enough to withstand summary judgment against”

    LOL. Meanwhile, “many of us” predicted this result before Bilski, and we predicted that Bilski would affirm this result. How did that happen? Luck?

    Consider that your meter needs adjusting. And your statement above that the alleged increasing complexity of patent cases is related to the CAFC’s alleged “hostility” to patents makes no sense. How are the two related? The alleged increasing complexity of patent cases is more likely driven by the increased ability of lawyers to generate and analyze reams of paper with greater east than ever before.

    The failure of the CAFC to reign in silly patent litigation can be explained, in part, by the CAFC’s:

    1) Failure to recommend or apply Rule 11 sanctions.
    2) Failure to issue their decision in Phillips earlier.
    3) Failure to continually gut the doctrine of equivalents at every opportunity
    4) Failure to clean up the stoopit preamble case law
    5) Failure to clean up the stoopit “product by process” case law
    6) Failure to beg for someone to present them a case so they could squash Beauregard claims out of existence

    Other than that, the CAFC is doing a pretty good job.

  52. Thanks for your comments, Mr. Stein.

    Whether the CAFC’s pro-patent precedents are just a faithful application of old precedent or not is eminently debatable.

    In Washburn v. Gould, Justice Story charged the jury that the burden of invalidating the patent was “beyond a reasonable doubt,” 29 F. Cas. at 320, which seems clearly out of place in a modern civil case. SSIH doesn’t cite Washburn, section 282 doesn’t require “clear and convincing” by its terms, and iirc, before the CAFC was created the courts of appeals had different views of what the standard of proof was. I therefore don’t think it’s inaccurate to characterize that part of the CAFC’s law as a “pro-patent move.”

    I think you misread Justice Roberts’ concurring opinion in eBay. I read it as agreeing with the majority’s opinion, bolstering its reasoning a bit, and adding a cautionary note that the majority opinion shouldn’t be read as open season on denying injunctions after a finding of infringement. In other words, the “long tradition of equity practice” should continue, but it was never a rigid entitlement or a general rule, as the majority properly held, and as the Federal Circuit seems to have forgotten since Roche (otherwise eBay would have been an affirmance, not a vacatur+remand).

    I have to get back to work, but my recollection of TSM is that KSR credited the CAFC with constructing it in its then-current form. No doubt the CAFC derived it from prior precedents, but the particular way it developed and was applied by the CAFC was “pro-patent” and was not strictly required.

  53. DDC writes: “I suspect that Judge Newman would write a much different ‘full’ opinion on the case than would Judge Moore.”

    Perhaps this is why the opinion ended up so short. Maybe the judges agreed on the result but couldn’t much agree on the rationale… and instead of writing 3 separate opinions, they just glibly announced the result.

    If that’s what happened, then it seems defensible. Bilski is a new rule and the court should speak with one voice to the extent possible as it begins to apply it. If the first post-Bilski case was a mess of separate opinions with no majority opinion, that would probably do more harm than good.

    Just speculating…

  54. anonymous wrote:

    “…the court made a bunch of pro-patent moves, including reading the ‘clear and convincing evidence’ standard into section 282…”

    That standard was invented in Washburn v. Gould in 1844. The CAFC merely affirmed it in 1983 (SSIH v. U.S. ITC) and has applied it ever since.

    ===

    “…coming up with the TSM test for obviousness…”

    Nope. That concept predates the CAFC, and even to a certain extent the CCPA. See In re Lintner (1962): “Differences between a patent applicant’s and the prior art’s motivation for adding an element to a composition may be reflected in the composition ultimately produced…”

    ===

    “…and making injunctions almost automatic once a patentee has proved infringement.”

    Again, the CAFC’s more generous grant of injunctions is a continuation of long-standing practice. The CAFC even held so in Roche Products v. Bolar Pharmaceuticals (1984), and the dissent by Justice Roberts in eBay noted that the Court was changing a “long tradition of equity practice” dating back to “at least the early 19th century.”

    ===

    “Regarding ‘facing facts,’ the CAFC hears tons of patent appeals, many of which are frivolous and most of which are poorly briefed.”

    Those holdings generally don’t set meaningful precedent – they just resolve the dispute at bar using a straightforward application of law.

    But for precedent-setting cases, the CAFC has been chronically thumping patentees. Sorry I don’t have any statistics for you – as I wrote, I WISH they were available (but they’re not.) Until someone compiles them to disprove me, I’m going to assert that patenting has become a much more complex, expensive, protracted, and uncertain process over the past five years – thanks not only to a truculent USPTO, but also to a generally hostile CAFC.

    ===

    “If the CAFC affirms without opinion, then the losing party has most likely already received an explanation of the deficiencies in its case from the district court and usually has little to complain about.”

    And if the CAFC had merely denied cert of this case, no one would have batted an eyelash. But here, it affirmed with a conclusory rejection under section 101 – in a case that, to many of us, seemed *clearly* to satisfy the Diehr test as described by Bilski, let alone enough to withstand summary judgment against! This holding simply adds to the hideous mess that Bilski made of section 101.

    And if you assert that the CAFC is careful to issue “clarification” in its precedential opinions – I will direct your attention to Bilski, in which the CAFC instituted a rigid test with a (primary) prong requiring “tying to a particular machine,” while expressly refusing to define what “tying” and “particular” mean.

    – David Stein

  55. Dennis “The accused infringers here include Biogen IDEC, GlaxoSmithKline, Merck & Co, Chiron, and others. I am surprised that these companies – which rely heavily on treatment method patents – would have argued strongly that the “immunizing” step was not sufficient to overcome”

    These companies develop new treatments whose patentability almost always rests on a novel active agent. They have very little to lose by (arguably) sacrificing a few method of treatment claims that were poorly drafted, and more to gain by getting rid of crap asserted by trolls which almost resemble Classen’s claims more than they do a real invention.

    Moreover, if worse comes to worse and the patent was actually crucial for some reason, they could likely file for a reissue to narrow the claims because (in some cases) they’ve built in written description support for transformative reporting or recording steps (or more). Again, many prosecutors in biotech were taking these steps well before Metabolite was a gleam in Justice Breyer’s eyes.

  56. Dennis: “I suspect that Judge Newman would write a much different “full” opinion on the case than would Judge Moore.”

    Oy. My stomach hurts just thinking about it.

  57. “(1) I’d have thought that “immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens” unquestionably satisfied the “transformation” arm of Bilski.”

    Then you are reading Bilski wrong. The “transformation” required by Bilski is not a trivial transformation arising from some step comprised by the claim. Bilski requires that the claimed method *yields* a tangibly transformed product.

    Otherwise we could use some of Babel Boy’s “reverse inherency” hoohaw to argue that a method claim results in the tangible transformation of oxygen to CO2 and water or the transformation of electrical energy into heat. It’s metaphysical junk and, as with the signal claim arguments, I can confidently state that nobody who matters is interested.

    One strategic question that presents itself is the usefulness of preambles. I despise preambles and more to the point I despise the case law regarding preambles. Preambles should be construed as limiting ALWAYS and in EVERY CASE (and someday this will become the law because the current state of the law is extremely silly). The question is: can a patentee have get further in these 101 cases with a generic preamble (“A method comprising the steps of”)? In other words, is it helpful to obscure the point of the claimed invention as much as possible so the irrelevance of any arguably transformative steps becomes less clear? Obviously, this is not a strategy for long term success but it’s indisputable that many prosecutors are very interested in obtaining claims for their clients regardless of whether the claims have a chance in helll of standing up in court.

  58. I think Mark Beatty got it exactly right: the process that’s claimed does not physically act upon or transform anything. Heck, it doesn’t even require you to transform a piece of paper by writing down your results.

    The experiment can be as spectacularly transformative as you like (A method of determining if an object resists thermonuclear explosions…), but if the “determining” process consists merely of “comparing”, under Bilski the claim reads on nothing patentable. The fact that you’re comparing vast tracts of still-smoking radioactive rubble doesn’t help — not even if the experiments are done in triplicate.

    If you buy into Bilski, this really didn’t require much more than the one paragraph Judge Moore dedicated to it. The take-home lesson is that for methods of measuring, observing, and especially “determining”, we need to draft claims with particular care.

  59. “but if the panel felt that the parties’ briefs were unhelpful, it could have asked for supplemental briefing after Bilski was handed down.”

    Anonymous,

    Also a fair and very astute point. The decision handed down here leaves more questions than answers.

  60. smashmouth “Breyer wrote in dissent of dismissal/cert improvidently granted, so his opinion in Metabolite might have persuaded you or me, but it’s not law.”

    I never said that Metabolite created new law. What I said was that Breyer made it perfectly clear that Metabolite’s claim was dead under existing law that precluded claiming “novel” mental steps.

    EG: “the holding Bilski is not only complex but confusing as to how you apply the “machine or transformative” test”

    I’m sure there are factual scenarios on the borderline that Bilski might not have addressed clearly. But in this claim there are no machines recited, particular or otherwise.

    Nor does the claim recite a novel method of transforming anything. The claimed invention is not a method for immunizing mammals so, like a step of “breathing air”, that step is irrelevant to the statutory consideration under 101.

    The claim is a method for “determining”. If you want a 20 year monopoly on a method of “determining” something, then you MUST recite more than “comparing” data, regardless of how your data is collected.

    If you’ve got a new method of collecting data, then for god’s sake just claim it.

    Now, the unclever “quick-fix” attorney will be tempted to draft some worthless garbage such as “comparing, wherein said comparison determines the answer being sought.” That’s not a transformation. It’s just more mental stepping.

    The result must be recorded or reported to meet 101, and the latter seems more significant to me. Note that, without the reporting step, a step of “doing something transformative if X is determined” *may* get you out of 101 but I do not believe the patentee can rely on the novelty of the mental step to get out of a novelty or obviousness challenge to the claim if the method in the absence of the mental step is old. I can already hear some whining about this conclusion but please try to remember: if the mental step isn’t necessary for novelty or non-obviousness, then for the love of trees please do not include it in the fracking claim.

  61. EG, you make a fair point about the value of an opinion applying Bilski. After Medimmune, the court was almost tripping over itself to elaborate on it.

    More clarification on Bilski will have to wait another day. I’m not sure why the panel chose to punt this one. I don’t know when the briefing happened in this case, but if the panel felt that the parties’ briefs were unhelpful, it could have asked for supplemental briefing after Bilski was handed down.

  62. “I would LOVE to see a scorecard of the number of anti-patentee vs. pro-patentee opinions the CAFC has issued in the last three years. I’d put safe money on a ratio greater than 2:1.”

    Then perhaps you can go look for one and report back instead of talking out of your rear end. You don’t seem to have any facts for us, but insist that we “folks” should “face them.”

    Among the many reasons for setting up the CAFC was a desire to make the courts more pro-patent, and the court made a bunch of pro-patent moves, including reading the “clear and convincing evidence” standard into section 282, coming up with the TSM test for obviousness, and making injunctions almost automatic once a patentee has proved infringement. The court also, iirc, famously affirmed a half-billion-dollar damage award in the Polaroid case and more recently affirmed the district court’s work in the Blackberry v. RIM case. The Supreme Court hasn’t been totally happy with all of this.

    Regarding “facing facts,” the CAFC hears tons of patent appeals, many of which are frivolous and most of which are poorly briefed. If the CAFC affirms without opinion, then the losing party has most likely already received an explanation of the deficiencies in its case from the district court and usually has little to complain about. The court arguably overuses Rule 36, but in many of those cases either (a) the appeal is frivolous, (b) the district court covered the issue so well that there’s no point in repeating what the district court said, or (c) the briefing is so bad that it’s hard to say much about the case with any confidence and it’s better to simply affirm on the ground that the appellant failed to show error in the decision below.

    If the CAFC reverses, it will always (afaik) write an opinion explaining the basis for reversal. If anyone’s ever seen a reversal without opinion, please let me know.

    Perhaps this case deserved a bit more explanation than it got but the “we are mere subjects” bit is more than a little rich.

  63. “(2) I’m shocked that the CAFC is now just issuing conclusory, blanket rejections under Bilski. By failing to take the opportunity to refine its shiny new test, the CAFC is casting itself as a fiat court for patentability.”

    David,

    I couldn’t have said it better myself. This terse opinion on what is far more important than just a case of interest to the parties involved doesn’t lend credibility (or dignity) to the Federal Circuit.

  64. …and the CAFC patent bonfire continues.

    I’m with the rest of you on two points:

    (1) I’d have thought that “immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens” unquestionably satisfied the “transformation” arm of Bilski.

    Here’s dictionary.com’s entry for “immunize”:
    1. to make immune.
    2. to render harmless or ineffective; neutralize.

    Both of those imply a very particular “transformation” of a mammal – and one that a medical science PHOSITA has been known how to implement for, what, 100 years?

    (2) I’m shocked that the CAFC is now just issuing conclusory, blanket rejections under Bilski. By failing to take the opportunity to refine its shiny new test, the CAFC is casting itself as a fiat court for patentability.

    Folks, let’s face facts: if your patent is litigated, the CAFC will merely write “yea” or “nay” according to its momentary whim (hint: expect “nay” more often than not… hell, most of the time.) Neither ask nor expect an explanation. We are mere subjects before the almighty Patent Deities.

    I would LOVE to see a scorecard of the number of anti-patentee vs. pro-patentee opinions the CAFC has issued in the last three years. I’d put safe money on a ratio greater than 2:1.

    In 1949, during a particularly vicious SCOTUS anti-patent phase, Justice Jackson wrote that “the only patent that is valid is one which this Court has not been able to get its hands on.” Time to revive that quote with regard to the CAFC.

    But in the spirit of the season, let’s look at the bright side. Given all of the lumps of coal heaped on patentees this Christmas season by SCOTUS, the CAFC, the BPAI, USPTO management, and the USPTO OED… if we pool all of that coal, we might have an infinitely renewable source of alternative energy!

    – David Stein

  65. MM said:

    “As Breyer made perfectly clear, Bilski was not necessary to kill Metabolite. Metabolite was dead under the law pre-Bilski.”

    If only that were true. Breyer wrote in dissent of dismissal/cert improvidently granted, so his opinion in Metabolite might have persuaded you or me, but it’s not law.

    MM also said:

    “Bilski wasn’t complex. What is complex is the prior case law, specifically the Supreme Court’s mumblings in Alapat and some of the other “classic” 101 decisions.”

    I think you meant “Federal Circuit” in the context of Alappat.

    Substantively, I thought Bilski was fairly complicated, in the sense that there was far from a consensus on the Federal Circuit, nor am I sure the test the majority devised will stand the test of time (or the Supreme Court). Not that I think Bilski’s complexity or lack thereof was relevant, in light of Federal Circuit Rule 36.

    Generally, though, I agree with you and several other posters that this claim was absurdly broad and encompasses the whole scientific method. (And that doesn’t even address the 103 issues.) But the 101 issue, I think, centers on the so-called mental steps doctrine.

  66. Mooney,

    Normally I would ignore you meaningless and poorly thought-through drivel, but in this case I’m going to make an exception because you’ve quoted only a portion of my comment without including the rest (“and only provide a one paragraph conclusory statement without any further explanation”). And contrary to what you might think (and as others have said), the holding Bilski is not only complex but confusing as to how you apply the “machine or transformative” test. And for this panel to simply apply Bilski to the Claussen case involving a significantly different type of subject matter without anything more than a terse paragraph is really poor form.

    “If Classen asks for rehearing “to get an explanation,” I wouldn’t be surprised if the clerk bounced the petition.”

    Anonymous,

    This isn’t a “per curiam” opinion affirming the district court on a case which is only important to the parties involved, but a panel making a ruling in an area of patent law that is in a complete state of flux, including what implications are for the Metabolite case. The panel’s opinion is so terse as to provide no meaningful explanation as to why Claussen’s claims were not patentable subject matter under 35 USC 101 other than “Bilski says so.” In an area of patent law that is so queasy now as this one, we (as well as Claussen) are entitled to more of an explanation than the one that was provided. In fact, it surprises me that Judge Newman wasn’t screaming about this one. Unless there’s something here that the panel didn’t want to go into (possible), this opinion makes no sense.

  67. “with a new 101 hammer, 103 problems are beginning to look like nails”

    did the district court’s summary judgment order include an SJ grant on the 103 issue?

  68. EG said:

    “This is a ghastly decision, whether or not it’s non-precidential. How can you have an opinion that is based on a case that is as complex as Bilski that is barely a month old and only provide a one paragraph conclusory statement without any further explanation? This has got to be the worst I’ve seen from the Federal Circuit. Claussen has a clear basis for asking for rehearing, preferably en banc, to get an explanation for why this panel did this.”

    I think you’re forgetting Federal Circuit Rule 36, which authorizes summary affirmances. See, e.g., Knauf Fiber Glass, GMBH v. Certainteed Corp., 08-1315, filed 12/15/08; Sumitomo Mitsubishi Silicon Corp. v. MEMC Electronic Materials Inc., 07-1578, filed 12/05/08; and numerous others linked on the Federal Circuit’s Daily Log page. So Dr. Classen got more than the minimum process he was entitled to as a matter of right.

  69. Several people here seem to have hit the nail on the head — with a new 101 hammer, 103 problems are beginning to look like nails. Mr. Mooney seems to have fallen for this as well.

  70. EG, the CAFC’s primary job is to decide cases. If the panel thinks that this case is clearly covered by Bilski, then there really isn’t anything else that needs to be said.

    If Classen asks for rehearing “to get an explanation,” I wouldn’t be surprised if the clerk bounced the petition. See CAFC Rule 35(b) and FRAP Rule 40(a)(2).

    Jim Demers, who’s “they”? If the district court only addressed 101, then that’s just about all the CAFC can address on appeal.

  71. Is anyone really bothered by this decision? The applicant was trying to get a patent on the scientific method.

    It seems that the lesson regarding “transforming a particular article into a different state or thing” under section 101 is correctly focused on the subject matter of the claim as a whole – just like obviousness and indefiniteness standards. The applicant here was not claiming a method of immunizing animals, but merely of collecting information on immunization effectiveness. The end result was merely data, which was not used to act upon or transform anything. The mere fact that they performed a physical step within the process does not change the fact that the claim as a whole is not directed to transforming anything.

  72. “A method of practicing the scientific method to determine whether Factor X affects an attribute of Thing Y when applied to Thing Y, as compared to a control group of Thing Y to which it has not been applied which comprises:

    applying Factor X to a test group of Thing Y, and

    comparing the levels of the attribute in the test group with the levels of the attribute in the control group.”

    FYC

    I know this is a 101 discussion, but seriously….

  73. A method of determining whether doing X affects Y in a treatment group, relative to a control group, which comprises:
    doing X, and
    comparing Y, in the treatment group,
    with that in the control group.

    I haven’t researched this, but I suspect it’s been done before. Often enough to be obvious — and with an expectation of successfully getting a yes or no answer.

    My only question is, “Why on earth did they need Bilski to shoot this down?”

  74. Malcolm, you are mixing section 101 analysis with the prior art analysis. Granted Classen’s claim may not be patentable over the prior art, but that is not part of the section 101 analysis.

  75. 1. A method of determining what, if at all, the Fed. Cir. is thinking, the method comprising:

    (a) reading a Fed. Cir. decision and responsively transforming one’s mind as a consequence of said reading from one state to a different state;

    (b) making up a speculative story about what the Fed. Cir. is thinking based on said transformation of one’s mind; and

    (c) publishing the made up story for consumption by and commenting on by readers of Patently-O.

    2. The method of Claim 1 and further comprising:
    (d) second reading responsive comments on Patently-O to said publishing step and further transforming one’s mind as a consequence of said second reading from a current state to a different third state.

  76. “How can you have an opinion that is based on a case that is as complex as Bilski”

    Bilski wasn’t complex. What is complex is the prior case law, specifically the Supreme Court’s mumblings in Alapat and some of the other “classic” 101 decisions.

    But Classen’s claim is dead a million ways to Sunday. Why would the CAFC waste it’s time on such junk?

    Let’s paraphrase Classen:

    “A method of thinking a vague thought about the results of an old experiment, comprising:

    Doing the old experiment, and thinking a vague thought about the results.”

    Seriously: what exactly is it you need to know?

  77. This is a ghastly decision, whether or not it’s non-precidential. How can you have an opinion that is based on a case that is as complex as Bilski that is barely a month old and only provide a one paragraph conclusory statement without any further explanation? This has got to be the worst I’ve seen from the Federal Circuit. Claussen has a clear basis for asking for rehearing, preferably en banc, to get an explanation for why this panel did this.

  78. ” In my opinion this claim is closer to being statutory than Metabolite – I have no doubt that Metabolite would be rejected under 101 after Bilski.”

    As Breyer made perfectly clear, Bilski was not necessary to kill Metabolite. Metabolite was dead under the law pre-Bilski.

    And Classen’s claim is worse than Bilski’s, in my opinion. At least the patentee in Metabolite had come up with a new and non-obvious discovery. The problem in Metabolite was just crappy claiming and greed.

    The problem in Classen (at least with respect to the claim at issue) is that it is pure crap. Immunizing mammals = old. Comparing immunized mammals to non-immunized mammals = old. Dosing immunized mammals according to a schedule = old.

    There must have been some serious strict-TSM wanking going on during the prosecution of that claim. It’s really quite sickening. Good riddance.

  79. ” “immunizing mammals” step makes it patentable subject matter. ”

    Friends, if you think it’s that easy to turn a pile of worthless crap into patentable subject matter, you are not paying attention. Why not just in a step of “breathing air” into the claim? After all, your honor, it’s transforming oxygen to carbon dioxide!!!!

    Yes, you are actually going to have to use your brains and THINK. Do you know why? Because the attorneys that are going to be asked to take down these crap diagnostic and screening claims are going to be working very hard to explain why some evidently “transforming” step contributes zilcho to the statutory requirements under 101.

    Therefore, simply following the advice of your out-of-touch supervisor or (god forbid) the PTO is not going to cut the mustard.

    Respectfully, there is no way to turn Classen’s claim into a valid claim without reciting *at least* a limitation requiring the use of a novel composition AND a step of reporting or recording the result (and I’ve commented before on the caveats regarding the latter).

  80. As I predicted. Zero surprises here.

    Classen’s claim (and also Classen’s invention, however it is described) is one of the worst examples of claim drafting I’ve seen in a long time. Did attorneys draft it? If so, maybe someone should consider a malpractice lawsuit. It’s that bad. Then we might ask yourselves: how in the HELLL did this claim get issued in the first place?!?

    We all know WHY the claim was drafted. The claim was drafted to get Classen “something” and probably also to fill Classen (or his sad attorney’s) pathetic requirement for an application with X number of claims.

    Leo appears to be the first commenter upthread to have understood the obvious: the step of “immunizing the test group of animals” is as irrelevant to the 101 consideration as a step of “breathing oxygen.”

    The preamble of the claim states that it’s a method for “determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals”. Presumably that was an art-recognized problem. Certainly the schedule of dosing is considered relevant in every other biomedical discipline, since about …. forever.

    The rest of the claim then describes steps in such a way as to cover every scientific method of achieving the result, including merely thinking about the relevant data.

    I love it when greedy patentees get hosed. Unfortunately, the public gets nothing out of this because there was nothing new or non-obvious about this claim, nor was it remotely enabled anywhere near to its massive scope.

    Judge Moore was right not to waste more than a paragraph taking out this trash. She saved the taxpayers’ money.

  81. “Hard to know when something crosses the line from significant to not.”

    It’s easy: just appeal to the Feds and they’ll tell you.

  82. I agree that the immunization step is some sort of physical transformation – their logic must be that it is insignificant. Hard to know when something crosses the line from significant to not.

    It is fairly analogous to Metabolite, except the insignificant or data gathering step is necessary to practice a mental step rather than a law of nature as in Metabolite. In my opinion this claim is closer to being statutory than Metabolite – I have no doubt that Metabolite would be rejected under 101 after Bilski.

  83. “Thank goodness this case in not precedential.”

    It wouldn’t matter if they designated it as precedential – it doesn’t provide any legal statement at all. As a result, it’s absolutely meaningless. Dr. Classen simply failed to convince either the district court or the CAFC of his position. That’s the only real take-away.

    “A mammal being immunized has not been transformed? Or is it that a mammal is not a ‘particular’ thing?”

    Insignificant pre-solutioni activity? The immunization step is really just setting up the claim; it’s not really the heart of it. In other words, the actual output of the claim, i.e., the result of the comparing, does nothing to “transform” the mammals.

    Now that I look at it, what is the outcome of the method? The “determining” that’s recited in the preamble? It’s probably a good thing that the court didn’t elaborate on its reasoning. This claim is doo-doo.

  84. Could the claim have been saved by doing something with the comparison?

    I think the court is saying it isn’t a claim for immunizing and immunizing is known. The immunization is an incidental step to what is being claimed “A method of determining whether an immunization schedule affects…”

    There is no step for reaching the claimed determination based on the comparison (or any other way).

  85. The one paragraph opinion leaves trying to guess what exactly the Fed Cir. thinks is wrong with the claim. Perhaps the tranformation of the mammals immune state is deemed to be an insubstantial data gathering step, since the goal of the method is not really the transformation per se, but instead the determining of the effectiveness (or lack thereof) of an immunogen according to a specific schedule. Maybe some transformations are more transformative than others and some unstated threshold of transformation must be crossed to count toward patentable subject matter. But given the very brief opinion, we’ll never really know how the court thinks the Bilski criteria aren’t met.

  86. A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises:

    receiving, in an treatment mammal, a dose of immunogens, according to the immunization schedule;

    transforming, in the treatment mammal, immune properties of the mammal to include immune properties of the dose of immunogens; and

    outputting, from the treatment mammal to a researcher mammal, information used to determine incidence, prevalence, frequency, or severity of the chronic immune-mediated disorder or the level of a marker of such a disorder when compared to the control group.

    … then sue the treatment mammal.

  87. Thank goodness this case in not precedential. Moore is confused. How can there *not* be a transformation here (unless the immunization is completely ineffective)? Maybe if the claim were rewritten “physically transforming mammals into an immunized state by applying…” Moore would see that.

    There’s a better 101 argument that this claim lacks utility, though again it’s tough to argue that immunized mammals aren’t useful. (I know a few whales that developed measles, but that’s another story..)

    But I’d say there’s a 112 indefiniteness problem with the “comparing” step, which would have been a better hook.

    EM

  88. A mammal being immunized has not been transformed? Or is it that a mammal is not a “particular” thing?

    Moore is . . . lacking.

    We are still waiting for CAFC to explain 1) “particular” 2) what it means to be tied to a machine.

    They are all beginning to look like dolts on this Bilski thing.

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