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December 19, 2008

Vaccination

Bilski has no basis in statute, and by any reasonable metric of jurisprudence, is downright bad case law. That's right, Chief Judge Michel, I am addressing you, sir. You are just making stuff up willy-nilly. But it doesn't help that prosecutors draft jackass claims, which examiners let pass, and then, rather than sicing the big-footed Obzilla on them for a good stomping, it's just too easy to rule: "damn, son, you can't patent that." We are talking a chronic disorder here.

Classen Immunotherapies v. Biogen and GlaxoSmithKline and Merck and Chiron and Kaiser-Permanente (CAFC 2006-1634, -1649)

5,723,283:

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.

Compare a control group to an immunized group. The boys back at the lab are just awed at how novel that is.

In one easy paragraph, a CAFC panel agreed with a district court judge that comparing things does not qualify as a requisite transformation.

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.

You inventors want claims that'll stick to the ribs of infringers, and not bounce off because of some dime-store case law? You just need to dial Platinum Patents.

Posted by Patent Hawk at December 19, 2008 1:57 PM | § 101

Comments

"You are just making stuff up willy-nilly."

Your beef should be with the Supreme Court's ill-conceived caselaw, not the Federal Circuit's best attempt to make sense of that caselaw. Given the Supreme Court's KSR smack down, the Federal Circuit must have known that it must jive its precedent with the Supreme Court's precedent. Sadly, the Supreme Court's precedent was made up willy-nilly.

Posted by: anonymous at December 19, 2008 4:25 PM

"That's right, Chief Judge Michel, I am talking to you, sir."

Right on. It's about time we practitioners start talking truth to power, especially when the power has gone off the deep end. In re Bilski is definitely a long irrational walk down a pier short of scientific facts and substance. How can any rational person say that immunizing a mammal does not transform the mammal (a.k.a. a composition of matter) into a different state (e.g. a different composition of matter)?

Welcome to the post-Enlightenment age.

Posted by: step back at December 19, 2008 4:50 PM

step, you might be right that immunizing animals changes the animal to a different state but "determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals" does not. The whole point of the claim is that the mammals might or might not be changed by the immunization and you're finding out if it is or not. For instance I can give you sugar water to immunize you against the flu. Doesn't mean that it actually did immunize you. And a claim to finding out if it did or not doesn't require that it did.

Is that not correct?

Posted by: 6000 at December 19, 2008 8:03 PM

6000 correctly read the claim, and blog entry. The claim did not go to immunization, but to comparison. Easily not patentable, Bilski notwithstanding.

Posted by: Patent Hawk at December 19, 2008 8:37 PM

Excuse me ... cough, cough, "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" ...

Sugar water is not an immunogen related to "incidence or severity of a chronic immune-mediated disorder". The immunogen doesn't change. It's the schedule that changes.

The preamble is part of the claim. The claim as a whole requires that you treat two groups, the control and the treatment group with the same immunogen(s), where the latter group is treated "according to said immunization schedule" and the control is not per the same schedule.

The comparing step inherently requires accessing each treated mammal so as to measure the compared attribute. The accessed and measured mammal is in an accessed/measured state which is different from the state it was in before it was accessed and measured. So both steps transform a composition of matter (the mammal) into a different state.

Posted by: step back at December 19, 2008 9:47 PM

Personally, I think the "immunizing" step is statutory, and the mental "comparing" step is non-statutory (i.e. it neither adds utility to nor limits the statutory immunizing step) because it is not subsequently used in a physical, transforming-the-real-world (e.g. outside the brain/computer/comparator) step.

So I think the claim is statutory, but the "comparing" step should be ignored (just like an "intended use" clause of an apparatus claim).

Now if the claim was to "A method of minimizing the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals... comprising the steps of: immunizing...; comparing...; altering the immunization schedule in accordance with [the comparing step results]; and immunizing... in accordance with the altered immunization schedule", that would be fine and all steps statutory. The "comparing" step then clearly limits (physically affects/transforms) the second "immunizing" step.

Posted by: NIPRA anonymous at December 20, 2008 4:38 AM

Personally (and with some modicum of respect, NIPRA), I feel that you are engaged in emotional feeling out of things rather than in rational, logical thinking out of things. If you are going to use words like "non-statutory", then by golly pull out the actual words of 35 USC 101 and show us where it says:

"Whoever {invents or discovers) ANY {new and useful} process [and here insert full definition of "process" from 100b], ... may obtain a patent therefor, subject to the condition [that their claim shall not have anything resembling a "comparing" step]".

And if you feel that this is what 101 says, then carry the notion to its extreme consequences by explaining why running grains of sand through a sieve is not a statutory step because, after all, you are "comparing" each grain of sand against the holes defined in the sieve. Those that are less than or equal to the size of the holes fall through; and those that are larger don't.

In the Classen method for discovering which schedule, if any, is better than the control schedule for immunizations, you are "comparing" two physical things: the immunized control group against the immunized (per schedule) test group. How is that logically so different than comparing grains of sand against holes in a sieve? In both cases you are comparing one physical thing against another physical thing. You are not mentally dreaming about "comparing". You are carrying out the actual physical process. Feel about that for a while and then please do come back to us with a rational logical explanation. /rant

(P.S., nothing personal, it's just that I feel too many folk on these blogs reach conclusions on the basis of pure emotion and without engaging in any rational cognitions; and also that they too easily give in to the voice of alleged authority without thinking critically for themselves.)

Posted by: step back at December 20, 2008 9:01 AM

Step back, the actual words of 35 USC 101 says "useful". To be statutory, an "invention" (i.e., as defined in the claims) has to have utility. What is the utility of the comparing step if you just keep it in your head (the claim says nothing more)? What is the utility of the comparing step in combination with the immunization step if you just keep it in your head?

If the step does not produce "a useful, concrete, and tangible result" in the context of the claimed invention, it is (in my mind) not statutory (101). That was my point....

A method of inflating tires comprising:

pumping air into the tires; and
simultaneously, thinking about the water vapor in the clouds.

Step back, is "intended use" a statutory limitation in an article claim (In re Schreiber)? Is a "method step" a statutory limitation in an article claim (IPXL Holdings)? I gave you an example of how I thought the "invention" should have been framed to have utility. No disagreement on my example, it that correct? It seems to me then this case was decided on sloppy claim drafting....

[And I can say, broadly, I have had to deal with claims having "dangling comparing clauses" before - this result is not a surprise to me at all (although I wish the opinion would have been clearer as to rationale).]

P.S. And with respect for you too: just because you don't see the rational cognitions doesn't mean there aren't any. ;-)

Posted by: NIPRA anonymous at December 20, 2008 11:02 AM

"The claim as a whole requires that you treat two groups, the control and the treatment group with the same immunogen(s), where the latter group is treated "according to said immunization schedule" and the control is not per the same schedule"

The claim doesn't say that lol. You're a lawyer right? Why do lawyers fail at reading claims? Where in the claim does it say that the control group is not treated per the same schedule? I presumed that as in normal control groups they were being treated with a placebo, on any schedule, including, but not limited to, the exact same schedule.

"Sugar water is not an immunogen related to "incidence or severity of a chronic immune-mediated disorder". The immunogen doesn't change. It's the schedule that changes. "

You're right sugar water isn't an immunogen, but since I didn't know one to spew forth as an example I filled in the blank. The point is that the immunogen might or might not immunize the patients. Very few immunizations that I know of work 100%. The whole point of the claim, so far as I can tell, is to see if the immunogen worked. You could be right that the point was to see if the schedule is better than another schedule, but it doesn't have NEARLY enough limitations to make it be that.

Oh, and step, after looking at the claim above, you are right, your intent is the proper intent they probably meant for the claim to cover. But, it doesn't matter since the claim is not limited to what was intended to be claimed, the only thing that matters is what was claimed.

Posted by: 6000 at December 20, 2008 8:57 PM

"Where in the claim does it say that the control group is not treated per the same schedule?"

In the preamble: A method of determining whether an *immunization schedule* affects the incidence or ...

Human nature is such that you're going to see what you want to see (or not see what you don't want to see) in the words of the claim. But then again, examiners are human. So I forgive you 6000.

Posted by: step back at December 21, 2008 4:21 AM

Disregarding the fact that the preamble is not limiting, the claim still would not be limited to the control group not being on the exact same schedule, they leave the schedule up in the air, and they also leave what particular thing about the immunization schedule that was found (i.e. did the schedule have the effect, or did immunization have the effect?) from the comparison up in the air.

I just do mah job and read the claim as broadly as is reasonble. It comes as second nature after awhile. As I said though, you're probably right, that's what they wanted to claim. Too bad they fail at claim drafting lol.

Posted by: 6000 at December 21, 2008 7:08 AM

Since I like a challenge, I googled some art right fast. Is this art that reads on that claim under your interpretation?

http://www.ncbi.nlm.nih.gov/pubmed/8561109

Posted by: 6000 at December 21, 2008 7:13 AM

I should add that took one google search and was the second hit.

immunization schedule comparison

lol

I might be speaking too soon but it appears hepatitis B is indeed a chronic immune-mediated disorder so chalk me up one!

I should also add, what I just did equates to roughly 500$. That is ridiculous.

Posted by: 6000 at December 21, 2008 7:22 AM

Aww, he beat mah date! I would go back by a few refs, but I don't have the time this morning, break time is up.

Posted by: 6000 at December 21, 2008 7:31 AM

Aww shucks, 6K, remind me to teach you how to use Google Scholar Advanced Search sometime, o.k.? That way you can use your keywords with hits limited to publications from 1993 and before (or whatever date range you're interested). And that way, the first hit will be what you want, so you can take a real coffee break. :-)

[But do read MPEP 1701.]

http://scholar.google.com/scholar?as_q=immunization+schedule+comparison&num=10&btnG=Search+Scholar&as_epq=&as_oq=&as_eq=&as_occt=any&as_sauthors=&as_publication=&as_ylo=&as_yhi=1993&as_allsubj=all&hl=en&lr=

First hit:

http://www.ncbi.nlm.nih.gov/pubmed/2530289

Step back, assuming pumping air into the tires is the only prior art (and NOTHING is obvious), I say ONLY claims 6 and 10 are statutory as defining useful inventions. To have the PTO spend resources to locate the non-statutory limitations a) through h) in claims 1-5 and 7-9 is (to me) a COMPLETE waste of resources because none of those limitations define "useful" inventions. Can you see how sloppy claim drafting by the applicant should not result in spent resources by the PTO? Yet many [un-?]learned attorneys try to get claim 1, purposefully stopping the framing of the "invention" at the very first step that is not shown by the prior art, thinking they are thus securing broader, warranted coverage for their clients, when in fact they have not defined a useful invention.

1. A method of inflating tires comprising:
pumping air into the tires; and
estimating a probability of rain. [- limitation a)]

2. A method of inflating tires comprising:
pumping air into the tires; and
detecting a probability of rain. [- limitation b)]

3. A method as recited in claims 1 or 2, further comprising:
estimating an ambient air temperature. [- limitation c)]

4. A method as recited in claim 3, further comprising:
comparing the air temperature with 32 degrees F to indicate freezing conditions. [- limitation d)]

5. A method as recited in claim 4, further comprising:
detecting a tire pressure in the tires. [- limitation e)]

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.

7. A method as recited in claims 1 or 2, further comprising:
detecting an ambient air temperature. [- limitation f)]

8. A method as recited in claim 3, further comprising:
comparing the air temperature with 32 degrees F to indicate freezing conditions. [- limitation g)]

9. A method as recited in claim 4, further comprising:
detecting a tire pressure in the tires. [- limitation h)]

10. 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.


Posted by: NIPRA anonymous at December 22, 2008 6:51 AM

...oops, claims 8, 9, and 10, should have depended from claims 7, 8, and 9, respectively. [Claim 7 was meant to show how a mental "estimating" step (claim 3) and a physical "detecting" step (claim 7), *without more*, have the same effect.]

Posted by: NIPRA anonymous at December 22, 2008 6:56 AM

NIPRA anonymous,

Don't you know that MPEP 1701 doesn't apply to 6000, because,.... um,... er,....

6000, why doesn't MPEP 1701 apply to you?

Posted by: breadcrumbs at December 22, 2008 7:51 AM

breadcrumbs, touché, I stand corrected. :-)

Posted by: NIPRA anonymous at December 22, 2008 8:17 AM

"Aww shucks, 6K, remind me to teach you how to use Google Scholar Advanced Search sometime, o.k.? That way you can use your keywords with hits limited to publications from 1993 and before (or whatever date range you're interested). And that way, the first hit will be what you want, so you can take a real coffee break. :-)"

Awww shizzle. Such a gem exists? It should be in regular google too, google scholar is often too restrictive, though useful sometimes. I will look into it though. I bet my backwards citation would have gotten to that hep B result in a jiff though.

MPEP 1701

I never said the claim was invalid or valid :)

There's a good chance that the claim could be valid or invalid. Even with anticipatory art. As with all claims "The question of validity or invalidity is otherwise exclusively a matter to be determined by a court."

"No USPTO employee may pursue a bounty offered by a private sector source for identifying prior art."

Does not stop me from finding prior art.

Also, it does not stop you from taking me to lunch for identifying prior art.

If those guys had lost the 101 battle, why wouldn't they have just struck hard and true with 102?

Posted by: 6000 at December 22, 2008 10:08 AM

"Also, it does not stop you from taking me to lunch for identifying prior art."

MPEP 1701 might not, but this does:

http://www.uspto.gov/web/offices/com/advisory/acrobat/pto2000e.pdf

:-)

Posted by: NIPRA anonymous at December 22, 2008 5:22 PM

6000,

Be careful. NIPRA might go under another alias elsewhere; Hannibal Lecter. In that case, taking you out for lunch may not be construed specifically as you intended. On the other hand, it will be one more welcomed "disposal point" for those here who don't exactly agree with your anti-inventor ideology. ;-)

Posted by: step back at December 22, 2008 7:05 PM

Guys,

Aren't we being a little hard on our pal 6000? He's had a tough month, being beat up on all these blogs, having his pal Toupin laughed at in open court, Appeal Rules being pulled because, well, because "some other agency" didn't get the job done (snicker). It's Christmas, let's be nice to 6000.

On second thought, let's not - PILE ON!

Posted by: Noise above Law at December 23, 2008 5:45 AM

Step back, why thank you for the compliment.

Dear 6K, my humblest apologies, I was much too hard on you in my previous comment. Upon reconsideration, yes, I should like very much to meet you for lunch in the coming days - and, of course, I will buy.

We can meet at my favourite eatery at the south end of Old Town - it's a convenient hot spot just off of Washington St. called The Cauldron (1001 S Royal St). I'm sure you've passed by it before. The atmosphere is cozy and the food is exquisite (...the stew especially is to die for).

Just give me a call at work to set up your appointment - 703-912-1725. If for some reason you get a recording, you can try my cell at 772-257-4501. I look forward to meating you.

(j/k)

Posted by: NIPRA anonymous at December 23, 2008 5:54 AM