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December 22, 2008

Comments

Kevin,

Classen 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 recent and as convoluted as Bilski is and only provide a one paragraph, conclusory statement? This has got to be the worst I've seen from the Federal Circuit. It's especially bad in that everyone is wondering whether LabCorp v Metabolite remains good law. And as your summary suggests, no one knows exactly how Bilski's "machine or transformation" test is being applied by the Federal Circuit, including this case.

In fact, the panel's opinion is so terse as to provide no meaningful explanation as to why Classen's claims were not patentable subject matter under 35 USC 101 other than "Bilski says so." Right now, everyone is guessing. In an area of patent law that is as unsettled as this one, we (as well as Classen) 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.

"a mechanical application of the Bilski test, pending eventual Supreme Court review."

Does this "smack" of the very same rationale that TSM was smacked in KSR?

Hasn't the Supremes already told the CAFC in equivalent terms, "Hey, wake up and use common sense."

Is the CAFC learning the wrong lesson in becoming gun shy and being afraid to make an actual stand and instead making a very lengthy, very contentious, and poorly contained (leaving so many important terms un- or under-defined) decision in In re Bilski and its progeny?

Dear EG:

It's possible that Judge Newman put on her Greek philosopher hat and thought, "First, do no harm." This decision is almost as deficient as a Rule 36 affirmance would have been. It does signal the way at least some members of the court will apply Bilski; maybe if enough cases on diagnostics go the other way we'll get an en banc review. Of course, maybe Classen will prompt en banc review and then we'll see how the court wants to go.

Until then . . . thanks for the comment. Happy holidays

Dear Bread:

I think the CAFC, and the Supreme Court, will be much more amenable to black and white tests like this for patentable subject matter questions than for obviousness, because obviousness is a much tougher legal concept to parse.

Thanks for the comment, and Happy Holidays!

Kevin "It may be (although it is not clear from the reasoning in Bilski) that the Federal Circuit would consider the claim to be patent-eligible if the comparing or correlating steps were "tied to a particular machine or apparatus" (such as a clinical diagnostic computer); it is clear that such claims would be significantly more narrow and less valuable."

But Classen's claim has zero value because it could never be patented in its present form even if it passed 101. So actually, Kevin, the claim would be "more narrow" but it would be infinitely more valuable than the claim as it stands. Can we please strive for a higher degree of intellectual honesty (or rigor, at least)?

Also, I'm not convinced that merely transferring the mental step to a computer would satisfy 101 in this instance. Unless some output is provided by the computer and received by a user of the computer, there is no utility to a claim. A claim to a purely mental method is still purely mental whether it's a human brain, a horse brain, or a computer that's doing the processing. This is the long-term answer. Think ahead. Your clients will appreciate it.

EG: "Right now, everyone is guessing."

Correction: right now, you're guessing. I'm not guessing. I'm writing decent claims. Classen's claim is appalling on a number of levels, including 101. I find it very interesting that Kevin can write thousands of words about Classen's claim without noting that Classen's attorneys are either incompetent or liars.

Regarding 7464002, Kevin writes: "While we are at a far remove from Sadie Carnot and Lord Rumsford, could it not be said that this claim has the very same problems as the Labcorp and Classen claims...?"

Absolutely not. The claim is fundamentally different because it contains the clause "wherein the diagnosis is displayed on a display device" and, if you understood Bilski, you'd understand that there is your transformation. The claim is no longer a purely mental method. The post-solution activity is significant.

"And is this claim, from U.S. Patent No. 7,435,551, patentable under Classen?"

No, and it wasn't (properly) patentable under 101 before Classen, or before Bilski.

Dear Reality:

I think one of the problems in the discussion is when we decide that the claim is deficient on other statutory grounds as a basis for asserting the claim doesn't encompass statutory subject matter. That's apples and oranges: there are plenty of claims unpatentable on 102, 103 or 112 grounds that are clearly statutory subject matter, so the fact that the claim wouldn't be patentable for other reasons is irrelevant to the question at issue.

I think the problem with "thinking ahead" is that 1) since the CAFC isn't giving clear instructions in this area what's "ahead" will likely change when another panel decides a similar question, and 2) the point is that IF the claim was tied to a machine (even if all you had was a "mental" step as you see it), Bilski would say the claim recited patentable subject matter. (I shudder to think what patentable subject matter your clients will forego if you don't realize that.)

With regard to the readout, do you think it would make a difference, to this panel or to where either one of us stands on this issue, if Classens' claims had read "wherein immunization is detected by a readout in a radioimmunoassay?" What the '002 claim does is use the information displayed on the display device to "carry out diagnosis of the progress of degradation" by "comparing the first and second thermal transmission rates." I don't see how "comparing" thermodynamic values are fundamentally different from comparing biological ones.

You can take an intellecually rigorous position that diagnostic method claims should not be patentable; we can disagree, but it's a position. What the CAFC did here is apply Bilski mechanically, automatically, and categorically, and as such it does nothing for the bar, applicants or the public in helping decide this question.

One more thing: ad hominem argument is not the way we do things on this blog, because it is childish and doesn't advance the discussion. So try to keep it civil.

Thanks for the comment.

Kevin "the fact that the claim wouldn't be patentable for other reasons is irrelevant to the question at issue."

But it's extremely relevant to the question of the relative value of the claim with and without the "narrowing" limitation. That was the "question at issue". My point is a simple correction. A claim that is unpatentable under 101, 102, 103, and 112 is either LESS valuable than the same claim after the 101 problem is fixed, or equal value (i.e., zero value).

"try to keep it civil."

Certainly. But in a civilized discussion we do not pretend that unpleasant facts do not exist. One unpleasant fact here is that Classen's claim is frankly shocking to any honest Ph.D. who has a basic understanding of patent law. How can such a claim be filed and pursued (lustily pursued, in fact) in good faith? That's a question that is very much worth asking if we are interested in "civility."

"point is that IF the claim was tied to a machine (even if all you had was a "mental" step as you see it), Bilski would say the claim recited patentable subject matter."

Please provide the pin cite in Bilski where Bilski says that ANY claim "tied to a machine" is patentable subject matter.

"(I shudder to think what patentable subject matter your clients will forego if you don't realize that.)"

I shudder to think about the money your clients are wasting if they think that reciting a computer in their claims is sufficient to turn an unpatentable claim into a patentable claim. But all this is irrelevant. I'll buy you a sweater for Christmas.

"With regard to the readout, do you think it would make a difference, to this panel or to where either one of us stands on this issue, if Classens' claims had read "wherein immunization is detected by a readout in a radioimmunoassay?"

I'm not sure, Kevin, but that's because the clause you proposed is written as poorly as the rest of Classen's claim. Who is detecting the readout? What does detecting the readout have to do with the determination recited in the preamble? To get out of 101, Classen's claim needs to recite the step of **making** the determination in the preamble (including an explanation of how the determination is made) *and* reporting the determination or taking some other transformative step beyond the determination (say, separating the immunized animals from the non-immunized animals). There are all sorts of trivially "transformative" steps you can stick into the claim ("recording the identify of the immunized mammal on a piece of paper") but none of them matter when you consider the "invention" that Classen is trying to patent.

Dear Reality:

Point taken that a worthless claim has no value. My point was more general: diagnostic claims tied to machines will be less valuable because they are easier to practice without infringing.

Support for my suggestion that Bilski says a claim tied to a machine is patentable subject matter (which is not the same as saying it is patentable), is this quote from the opinion:

"The Supreme Court, however, has enunciated a definitive test to determine whether a process claim is tailored narrowly enough to encompass only a particular application of a fundamental principle rather than to pre-empt the principle itself. A claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing. See Benson, 409 U.S. at 70"

"Surely patent-eligible" seems pretty definitive to me.

With regard to the proposed claim language, I don't see that how the clause is written matters to the point: the '002 patent claim doesn't specify "who" reads the readout, either. Indeed, all of the steps in the boiler degradation claim could be performed by a person with a pencil and paper, and an input to a display readout.

But it sounds like you think you could write the Classen claim to cure its deficiencies (with regard to whether it is patentable subject matter). If so, please enlighten us.

Let's agree to stop shuddering over our clients, and I accept the sweater offer - I'm told that I look best in black.

Thanks for the comment.

It seems to me the problem with Classen (and Labcorp and the '551 patent) is that the claims are written to cover the very acquiring of information, rather than any significant use of it.

Perhaps PatentDocs will say that "the acquiring of information" is itself utility. I would disagree, as a non-biologist.

Theoretical physics (comparing the energy of a particle to a predetermined energy level) and theoretical biotechnology (comparing long-term effects of different immunization schedules) seem to be places where free discovery of inherent information is (or should be) protected. There's no "invention" in theory, and no new "discovery" either in the Constitutional sense since the underlying truth was there whether or not it was recognized by man.

When theoretical physics or theoretical biotechnology is used to produce applied solutions (high energy beam therapy, optimized immunization schedules), then those applied solutions warrant patent protection. But the theoretical processes that form the bases for all applied sciences should not be preempted by patents just because someone says he discovered (in 1993) a new process to obtain information regarding a theoretical truth which he did not invent.

NIPRA - as a biologist, I agree.

Kevin, as to the Bilksi cite, I agree that your is best bet. However, I think the "tied to a particular machine" test is not going to be fulfilled by the simple recitation of "a computer" anywhere in a claim, at least not in a claim like Classen's.

The difference between the 002 patent claim and your modified Classen claim lies in the relationship between the display and the invention. In the 002 patent claim, the transformation (the displaying of the boilder degradation information) *is* the invention. That is as it should be. That is what processes do: transform things. Novel, nonobvious processes transform things in novel ways, achieving unexpected results.

In your modifed Classen claim, you've added the recitation of a trivial transformation that has nothing to do with the (alleged)invention, i.e., "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". In both Classen's claim and your modified version of Classen's claim, the promised result is not necessarily delivered. That is fatal. You can call this the lack of a transformation or you can call it lack of a utility. The result is the same: dead claim.

By the way, let me also throw this out there: any alleged "process" claim that recites the word "if" is not a patentable process. It's a description of an algorithm and will not satisfy 101. Again, just looking ahead.

And that '551 claim is non-statutory under 101. You can take that to the bank.

You also wrote that "diagnostic claims tied to machines will be less valuable because they are easier to practice without infringing"

Easier to practice compared to what? The value of patents should be closely tied to the value of the technological contribution of the material disclosed in the patent. In the near future, when nobody is being granted mental stepping claims like Classen's (even accidentally by the incompetents at the PTO), then the question is moot. If "patent value" mattered, then why not lobby to get rid of 101 and 103 entirely and just have 102? Then the US will have the most "valuable" patents on earth!

Dear NIPRA:

I agree that information per se should not be patentable. That is why inventors who isolate genes are able to protect the isolated nucleic acid, but cannot protect use of the sequence information on a database. In the days when the only source of nucleic acid sequence was the nucleic acid itself, this was a trivial distinction. Today, it means that anyone can take a sequence from a patent, interrogate a sequence database, and find new, non-obvious sequences without any threat of infringement from the gene patent holder.

So we are not talking about information, except insofar as any diagnostic claim involves information. As I said upthread, there is a defensible position that diagnostic method claims should not be patentable. My inquiry was whether we really want to go that route, and if so do we want that to be the case for any "diagnostic" claim, using boiler degradation diagnostic as an example. There shouldn't be a difference because one claim is diagnosing a disease and the other is "diagnosing" a boiler.

But then some kinds of processes will not be statutory subject matter; for now, the CAFC says which is which can be determined by Bilski. But I'm not sure that is the right place, since it is a very black and white test.

I think diagnostic methods should be patentable because there is no policy reason why they should not be (under US patent law, of course; many countries around the world have "ethical" or "moral" reasons for restricting claims to processes involving human disease diagnosis or treatment). Physicians and other medical professionals are protected from infringement liability by 35 USC 287(c). These types of methods are almost always restricted to detecting certain markers for certain diseases, meaning that the detection of the marker itself is not pre-empted from use in diagnosing other diseases.

If we preclude diagnostic method claims from being statutory subject matter, we will lose the benefit of incentives for identifying markers whose detection can substitute for more expensive or invasive (or unavailable) biological tests. Where will be the incentive for identifying a metabolite diagnostic for Alzheimer's disease using a simple blood test, for example? Particularly if identifying the metabolite is not patentable per se? You, and others, may be comfortable protecting some pure ideal of patentability at the cost of such an assay, but I don't think it's a good idea.

Thanks for the comment.

Dear Reality:

Well, looking at the '002 claim I don't agree that the invention "is" the display. The claim reads:

"A diagnosis method for boiler degradation, comprising: calculating a first thermal transmission rate from a difference in thermal quantity of gas or steam between an entrance and exit of a heat exchanger with respect to at least one heat exchanger constituting the boiler; calculating a second thermal transmission rate based upon a thermal conductivity rate of pipes and thermal conductivity transfer rate of steam and gas of the heat exchanger; comparing the first and second thermal transmission rates; and carrying out diagnosis of the progress of degradation, wherein the diagnosis is displayed on a display device, wherein the boiler is a heat recovery boiler for recovering heat from a gas turbine."

I see the invention as performing a diagnosis by comparing the first and second transmission rates; if it is your position that the "display" portion makes the claim patentable, then we will just have to disagree - I don't see it.

But reasonable people can differ. Whether claims containing "if" are always unpatentable is an interesting question; according to the US PTO database, there are no claims containing the word "if."

Thanks for the comment.

"according to the US PTO database, there are no claims containing the word "if.""

The Examiners' search tools EAST and WEST have "stop words" which cannot be searched... like "the", "a", "an", etc. I assume "if" is a stop word in the web search engine. (For example, the web search engine also provides 0 hits for "the" in the claims.)

Questel-Orbit's USPAT database has no stop words, and has special value for that reason. It returns 246,869 patents with "if" in the claims issued since 1971.

Aha, here's the stopword list for the web search engine:

http://patft.uspto.gov/help/stopword.htm

Kevin worries that precluding patents on diagnostic/prognostic methods will result in a loss of incentive to discover the basis for the disease or trait which underlies the method. I've heard this argument before, but I don't buy it. Compile a list of the most well-known or commercially successful diagnostic/prognostic assays, and you will find that the overwhelming majority are based on discoveries made by researchers at universities, government agencies, and/or other non-profit institutions. Take, for example, DNA-based disease diagnostics/prognostics. Any list of the top 10 would almost certainly have to include the following: Alzheimer's disease/APOE4, Tay-Sachs disease/HEXA, cystic fibrosis/CFTR, fragile X syndrome/FMR1, factor V Leiden thrombophilia/F5. Note that every one of these discoveries came out of universities, government agencies, and/or other non-profits. What I'm trying to say is that this stuff will be discovered with or without the possibility of patent protection. It's possible that what Kevin is really worried about is the incentive to develop and commercialize tests based on these discoveries. No problem there either. Take a look at the roster of tests of the large reference laboratories such as Quest, LabCorp, and ARUP. The vast majority of these tests are not, and never were, the subject of patent protection. So, whatever anyone thinks of Bilski, Classen, Breyer's dissent in LabCorp v. Metabolite, or the Becerra/Weldon bill, make no mistake about this: patents or no patents, these discoveries will be made, and products will be commercialized based on such discoveries.

Dear NIPRA:

Thanks! I'm obviously not a database guy, and I appreciate the information.

But it does seem to indicate that "if" is used in lots of patent claims, and they can't all be diagnostic ones. Did you look to see if there are any ("if" and "diagnos!"?

Thanks for the comment and information.

Dear Gary:

I'm not surprised that diagnostics claims arise all the time in academic setting, especially in the past 10 years, because that's where a lot of the basic research is being done. And I wouldn't assume that this is equal to "the research will be done anyway." First, Bayh-Dole opportunities have motivated many universities to pursue patent protection on these types of inventions, and academic research is focused today on more practical applications of their discoveries - in the past, a diagnostic application might have garnered a mention at the end of a paper about the underlying biological phenomenon, but that wasn't (and isn't) the focus of the research. Rather, it is a practical application of the underlying phenomenon.

Second, the pharma and biotech industries have become important funding sources in this area, and without patent protection there would be much less of this (since they want the payoff of exclusivity to support their investment).

I was surprised at the assertion that Quest etc. don't patent their assays. But what about this claim, assigned to Quest Diagnostics (USP No. 7,439,026):

1. A method for detecting trophoblastic disease in a subject comprising: (i) contacting a biological sample of the subject in a combination assay with at least two capture antibodies that specifically bind different epitopes of invasive trophoblast antigen (ITA), and hCG, and at least one detection antibody that binds an epitope of the ITA and hCG different from the epitopes bound by the capture antibodies, the at least one detection antibody being coupled to a label that is effective to produce a detectable signal in one assay; (ii) detecting a signal produced by the label when the detection antibody is bound to ITA; (iii) confirming that the subject is not pregnant; and (iv) comparing the total ITA and hCG signal generated in the sample to the signal generated in a sample obtained from a normal, non-pregnant subject, wherein an elevated signal in the sample relative to the sample from the normal, non-pregnant subject indicates trophoblastic disease in the subject.

Also, I know such companies that have licensed academic and small company patent rights for such assays (although I presume this is more to avoid a patent infringement lawsuit than to use offensively against competitors). An alternative would be that the assays were so well-known that there was little point in patenting, or that there was a sufficient market advantage that patenting wasn't necessary.

Of course, part of the reason may just be that "big reference labs," like almost every established industry except pharma, doesn't need patent protection as much as smaller companies. So long as these companies are providing the tests, we won't have the problems I envisioned. Of course, so long as academic and small biotech labs are doing the basic science, reference labs won't have to. But I'm not sure a patent system that enables big companies to expropriate the inventions of small ones, or of government-funded research, is the best policy.

Thanks for the comment.

Kevin, approximately 3,637 patents have "if" and the stem "diagnos!" in the claims.

But I think the "if" question is not as simple (or conclusive) as Reality suggests.

I understand his point to be that (in the simple case) if the "if condition" is not true, then the limitation is not claiming anything. (Correct me if I am wrong, Reality.)

The flip side of his point though (which he perhaps has not considered) is that if the "if condition" is not true, then the patent claim does not apply. That is, the scope of the claim is expressly limited to when the "if condition" is true.

Or to say it as an if-then statement:

If the invention (claim) is framed in terms of "when the if condition is true", then infringement can only exist "when the if condition is true".

A second point is that "if" clauses are not only framed as "if-then" statements which don't limit when the "if condition" is not true, but also as "if-then-else" statements which limit regardless.

6. A method as recited in claim 5, further comprising:
terminating the pumping of air into the tires when the detected tire pressure is 30 psi if the probability of rain is greater than 50% and freezing conditions exist; and
otherwise, terminating the pumping of air into the tires when the detected tire pressure is 35 psi.

(Claim lifted from a Patent Prospector blog comment.)

Happy Holidays!

Kevin, I never said that Quest and the other reference labs do not perform tests that are not patented (whether by themselves or by another and then in-licensed). Of course some of them are. But most of them are not. Your point about industry-sponsored research is valid, but I think you will still find that most of this stuff is not being derived through such arrangements. Has Bayh-Dole been a success? I guess it depends on how you look at it. All I know is that only a handful of universities have actually made any money on technology transfer. Most universities treat it as a loss leader for faculty recruitment and retention.

Dear Gary:

I agree that most universities have not reaped the expected financial bonanza from patenting, but I think this is a reflection of lack of experience and the serendipity of commercializing even significant inventions. I agree it depends on your perspective.

Thanks for the comment. Happy holidays.

Dear NIPRA:

Thanks for the claim, and a fuller explanation of the "if-then" phenomenon.

Happy holidays.

Assuming the data collection step is old, claim 1 of USP No. 7,439,026 is invalid under Bilski/LabCorp.

If Quest is on top of their game, they have a continuation pending or are filing for a reissue to recite a reporting step or some other step that captures the novel contribution (i.e., the discovery of the relationship between the assay result and the disease state) in a sufficiently transformative manner. Presently (and assuming the data collection is old), the invention is claimed as a mental step, just as it was in Classen. That's fatal.

Dear Reality:

To parse your argument out from the string:

1) the Quest claim is not patentable subject matter because it includes a mental step;
2) the physical portion of the claim (the assay step) is not patentable because it is either anticipated or obvious over the prior art; and
3) if there was a "transformative step" such as a reporting step, that would make the claim patentable.

Question: could you give us an example of the form of the reporting step - would it need to be tied to a machine, for example?

Thanks for the comment.

Reality said:

"If Quest is on top of their game, they have a continuation pending...."

From PAIR:

12/252,282 filed on 10-15-2008 which is Pending claims the benefit of 10/716,739

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