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« Supreme Court Remands Myriad Case | Main | USPTO Issues Preliminary Guidance on Mayo v. Prometheus »

March 26, 2012

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"1. A method of administering 6-thiopurine to a patient in need thereof for treating an immune-mediated gastrointestinal disorder, comprising the step of administering a therapeutically effective amount of the drug that produces no less than 230 pmol and no more than 400 pmol per 8x108 red blood cells in blood from the patient."

Don't let the fact that you just drafted all over the prior art stop ya bro.


Bottom line Kev, there was no challenge issued implicitly or explicitly. Save that to stop being evil draftsman and abide by the law. This is not an exercise of drafting skill to "save these claims", if you even think about making such an exercise then by definition those claims are supposed to be invalidated.

This isn't really that difficult Kev. Stop being a scofflaw. Period. It is really not that hard.


"while implicit in the claim is the need to determine whether the administered amount produced between 230 pmol and 400 pmol per 8x108 red blood cells in blood from the patient, "

Not really.

"and the "deep pocket" liability will lie against the hospital or drug company that specifies the required determination."

What "required" determination? There is no determination recited. I swear Kev. This is like a first year lawl student trying to draft a claim.

"irst, it is apparent that claims reciting "active" steps will be much harder to pigeonhole into the "laws of nature" category than claims like the invalidated Myriad or Prometheus claims, because unlike in Prometheus it should be harder to categorize this as merely "selecting a population.""

Genius Kev, pure genius.

"Second, claims reciting novel "determining" steps (wherein what is administered is novel, or the relationship between what is detected and a particular disease is novel, or the method by which a biological molecule is administered or detected is novel), should overcome the "merely routine" basis used by the Court in invalidating the Prometheus claims. "

Lulz, gl with that. I don't understand how you've come to this arse backwards notion that there is something that which will "overcome" a certain "merely routine" basis used by the court in invalidating the Prom claims. Nothing "overcomes" that, it simply either is present from the outset of the analysis or it isn't. No "overcoming" is required.

"Finally, placing the "law of nature" in context, wherein the claim steps recite a method performed only when a "law of nature" is satisfied, may also suffice."

O? You mean like Prom did?

"But that doesn't mean America's patent draftsmen are helpless. "

Nah, it just means they're going to need a little extra smacking down for a year or so until they simmer down and start claiming only inventions.

"After 30 years of a relatively benign patent law regime under the Federal Circuit, the skies have darkened and the seas are rough."

L U L Z. Having to invent something is a real bia ain't it Kev?

Kevin,

Very perceptive thoughts. As you correctly say, while Breyer's opinion denigrates it, the "draftsman's art" is important here. I would also suggest looking at Claims 1 and 13 of related U.S. Pat. No. 6,987,097:

Claim 1. A method for optimizing therapeutic efficacy in a subject in need thereof, said subject receiving a drug providing 6-thioguanine, said method comprising: (a) determining a level of 6-thioguanine in said subject; and (b) increasing the subsequent dose of said drug when said level of 6-thioguanine is less than a member selected from the group consisting of about 230, 240, 250, 260, 280, and 300 pmol per 8 [times 10 to the 8th power] red blood cells.

Claim 13. A method for reducing toxicity in a subject in need thereof, said subject receiving a drug providing 6-thioguanine, said method comprising: (a) determining a level of 6-thioguanine in said subject; and (b) decreasing the subsequent dose of said drug when said level of 6-thioguanine is greater than a member selected from the group consisting of about 350, 370, 390, 400, 425, and 450 pmol per 8 [times 10 to the 8th power] red blood cells.

If Claims 1 and 13 of the '097 patent can't make the "patent-eligibility" grade under 35 USC 101, I frankly don't know what method or process claim would.

What we frankly need to bring back is the now discarded "tangible, concrete, and useful result" test. The TCU test would weed out method claims like those in Mayo Collaborative Services and Myriad which might make for some nice "theoretical discussion," but don't quite achieve a "useful result" in the patent method/process sense. We would do far better using the TCU test to judge patent-eligiblity under 35 USC 102; as I've said repeatedly, I could be just as objective as the reasoning in Breyer's opinion using a Ouija board.

Ah, 6, the trenchant commentary we have come to expect.

Patent law isn't like the speed limit on the interstate - there are many creative ways to protect inventions, and I predict my brethren will rise to the task. Intentional or not, this is the world the Supreme Court has made with its decision, and we will live with it. After all, KSR was supposed to be the end of the world as we know it and we have adapted to that just fine.

Thanks for contributing.

Kevin,

I've been reading your commentary for some time now and appreciate the lucid analytical viewpoint it offers.

I've been struggling, as I'm sure many will, to understand what will constitute an "unconventional" step that adds sufficiently to a method claim involving a law of nature, moving forward. I know the claims were unchallenged, but I think your comment regarding claims 2 and 26 of the '857 patent tees up a good opportunity to discuss this issue further in a defined context. I don't have a late 90s edition of Sambrook in front of me, but to me methods listed in the claims for comparing BRCA sequences and detecting a mutation read like a laundry list of methods that would have been familiar to a POSITA at the time and have been essentially "obvious to try." I realize that statement is loaded and plays into Breyer's alleged "conflation" of subject matter eligibility with obviousness criteria, but I'm interested in seeing additional viewpoints on this and these claims offer a perfect opportunity for further discussion. Simply because the methods would be more difficult, or less conventional, than simply sequencing the BRCA genes of a subject and analyzing or comparing them wouldn't seem enough to save the claims. If the methods are known, even though not the most conventional possible approach, at a given point in time, then isn't the necessary "inventive concept" still lacking?

"and I predict my brethren will rise to the task. "

I predict it as well, which is why I also predict more smack downs in the future. What we need are some lawls with harsher punishments being enforced on these scofflaw officers of the court.

6 - Thanks for providing your usual quantum of insight to the discussion.

In running with your "harsher punishments" chestnut, perhaps the PTO can begin to assess fines against the prosecuting attorneys for each rejection of claims they advance in an Office action. That would be great, particularly when I get a cut-and-paste 102(b) rejection from a completely different application that has nothing to do with my claims.

Or perhaps we can all take a deep breath and take inventory of where we are in the wake of Mayo.

Kevin

The following quote is taken from Diamond v. Diehr. Breyer’s opinion should be “hung, drawn, and quartered” for it does exactly what this quote from Diehr says not to do in an analysis under section 101:

In determining the eligibility of respondents’ claimed process for patent protection under 101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made. The “novelty” of any element or steps in a process, or even of the [450 U.S. 175, 189] process itself, is of no relevance in determining whether the subject matter of a claim falls within the 101 categories of possibly patentable subject matter.

Dear JK:

I think what is needed is what is not in the prior art - i.e., some way to identify the gene or mutation. That would be what is "new" - not the "natural law" that the mutation causes an illness, but the reagent to specifically detect it combined with the method for detecting it. I think there is a strong argument that no matter how "obvious" it might be to "try" to detect such a mutation, unless and until it is identified it is not "routine" or "conventional" to detect it; how do you detect something you have neither identified nor isolated?

While I understand that someone might argue that this is just "natural law" + "natural phenomenon," the Prometheus decision says you need "something more" that isn't "routine and conventional." Unless we want to put all biological and chemical inventions off-limits to patenting, I think the fact that the prior art would not enable the skilled worker to detect the relevant mutation even if told about it (by God, presumably) should take such claims out of the ambit of Justice Breyer's mighty patent-slaying rhetoric.

But we shall see. Thanks for the comment.

Kevin,

Having reviewed again the Federal Circuit remand decision in the Classen Immunotherapies case, that is the way home to keep the ruling from Mayo Collaborative Services from exploding into complete nonsense. Judge Newman's opinion (joined by Chief Judge Rader) very astutely points to the "immunization step" in the two patents (the ‘739 patent and the ‘139 patent) for why they made the patent-eligibility grade, while the '283 patent did not. These two patents might go down for other reasons (Newman also very carefully noted that the claims of these patents "may not meet the substantive criteria of patentability as set forth in §102, §103, and §112"). But the "law of nature" reasoning from Mayo Collaborative Services is completely inapplicable to these Classen claims. There may yet be some "light" in this currently "dark" patent-eligibility tunnel.

Dr. Noonan states in part "Unless we want to put all biological and chemical inventions off-limits to patenting..."

Careful sir, some really do want to do that.

"Or perhaps we can all take a deep breath and take inventory of where we are in the wake of Mayo."

I took that "deep breath" three years or so ago. I know precisely where you are. The same place I've been for a few years. But, I suppose, if you guys take a deep breath and decide to not scoff at the law then I will be satisfied. If this is just a moment of unwarranted panic then fine.

Kevin,

As you, I and others have said, what those who are “cheering” this decision need to understand (and accept) is that the specific result isn’t the problem for us, but instead the abominable reasoning that is employed in Mayo Collaborative Services, including mischaracterizing and misusing basic patent claim terminology. As my patent attorney younger brother Mark has aptly pointed out, Breyer’s opinion characterizes the “wherein clauses” as a “step.” That, by itself is embarrassing in the extreme. (And Mark and I aren't making this up, it's right in Breyer's opinion.) Any beginning prosecuting patent attorney or agent would understand that characterizing “wherein clauses” as a “step” is nonsense. If Breyer can’t get the basic patent claim facts right, is it any wonder that the reasoning he provides won’t be accepted by patent law practitioners, notwithstanding his further nonsensical characterizaton of what the applicable patent law is?

What is also very unfortunate is that Breyer could have had his “cake,” and even gotten us patent practitioner’s (at least most of us) to “eat it” too if he had used the basic patent claim terminology correctly and had framed the applicable patent law issue appropriately. Characterizing Prometheus’ claimed method as not much more than patenting a “law of nature” was the absolutely worst way to go. Instead, he could have gone down the path of Bilski and said that Prometheus’ claimed method is nothing more than an “abstraction” because it does’t achieve a “use result” (i.e., simply providing numerical ranges of what dosages are too high or too low isn’t enough to reach the patent-eligibility zone). Even better, Breyer could have pointed to related U.S. Pat No. 6,987,097, and particularly Claims 1 and 13, and said “that’s what I mean by a ‘useful result’ that is more than an abstraction.” Prometheus would have been unhappy, and there might have been some grumbling by some patent practitioners, but such reasoning would have been accepted by the patent law bar at large (me included), and would have also given us meaningful guidance on how to craft method and process claims to reach the patent-eligibility zone. (Sigh).

As I said before, the path forward for getting us out of this Mayo Collaborative Services debacle is through the Classen Immunotherapies remand decision. Judge Newman’s opinion (joined by Chief Judge Rader) very astutely (and presciently) points to the “immunization step” in two of the patents (the ‘739 patent and the ‘139 patent) for why they made the patent-eligibility grade, while the other ’283 patent did not. And Newman's opinion primarily relies upon a legal basis other than the Federal Circuit's "transformative" step reasoning that was reversed in Mayo Collaborative Services. I've written an article to discuss this path forward that should be posted soon on IPWatchdog. Stay tuned.

Kevin:
I worry that your recasting of the Prometheus claim as a method-of-treatment claim would go down under Section 102 as inherently anticipated by any previous administration of a 6-thiopurine drug. Inherent anticipation seems to be the rejection du jour.

Dear Sean:

Perhaps - unless it could be shown that administration in the past gave blood levels lower than 230 pmols and/or greater than 400 pmols. Inherent anticipation has to fall within the scope of the claim every time.

Thanks for the comment.

Kevin,

Nice write-up. I agree that the best path forward is to recast such "correlation" claims into MOT claims. The nature of such claims will vary, depending on the nature of the marker, the nature of the relevant disease, and the nature of existing prior art.

Folks who prosecute pharmaceutical patent applications should have plenty of experience drafting these kinds of claims, as prosecuting such applications is a routine part of lifecycle management.

Moreover, as you note, MOT claims have the potential to reach deeper pockets, as they implicate pharmaceutical companies as potential infringers under 371(b) or (c).

Of course, this begs the question: Why haven't the discoverers of these correlations been drafting MOT claims all along? I suspect that this failure is sometimes the result of unsophistication. But in other cases, I suspect that they don't because they can't: The resulting MOT claim may be anticipated, or, if not anticipated, no one has yet discovered any way to practically apply the discovery. So, in that vein, "correlation" claims seem to have become a popular means of skirting potential problems under 102 and 112 that their corresponding MOT claims may have suffered from.

Kevin "Inherent anticipation has to fall within the scope of the claim every time."

Just to be clear, if Mayo or another alleged infringer could show that a single previous administration of 6-TP resulted in the recited metabolite levels, that would suffice for anticipation. Remember: dosing and testing the metabolite levels was not old in the art.

Dear Dan:

I don't think so. My understanding is the opposite - that the prior art method for administering the drug would need to inherently produce those blood levels each and every time. If not the method reciting this limitation is not inherently anticipated.

Kevin: "the prior art method for administering the drug would need to inherently produce those blood levels each and every time"

This is true only when there is a gap in the prior art and an inherency agrument is used to fill in that gap. I'm not talking about that situation, but rather about the situation where the evidence is provided showing that (1) the drug was administered (2) the metabolite level was measured to be lower than the low bounding range recited in the claim and (3) more drug was given (proving that a "need to administer more drug was indicated"). That's just plain vanilla anticipation. It need only have happened once.

With respect to the inherency issue, that's even easier given the extraordinary breadth of Prometheus' claims. It would not be difficult to find an expert to testify that certain extremely low doses of 6-TG that were surely administered in the past would never yield levels of metabolites below the lower bound recited in Prometheus' claims.

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