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August 6, 2009

Patent Contraceptive

The danger lurking in obviousness is hindsight reasoning. A breakthrough becomes predictable. In hindsight, you/they/whoever should have seen it coming. Bayer's oral contraceptive, Yasmin®, had unexpected performance. The active ingredient, drospirenone, readily degraded in an acidic environment like the stomach. Grinding it to itty bits, i.e. micronizing, should have exacerbated the problem. So, logically, you'd coat it, to try to make more of the drug bio-available. Bayer found out that coating wasn't necessary, and micronizing didn't decimate bioavailability in an acidic environment nearly as badly as previously thought. That much was obvious. But only in hindsight.

Bayer v. Barr (CAFC 2008-1282)

Barr provoked Bayer by filing to produce a generic version of the drug. Barr convinced the district court to find Bayer's patented compound, via 6,787,531, obvious.

Because the use of drospirenone with 17α-ethinylestradiol as an oral contraceptive was known prior art, Bayer represented that the innovation was to micronize the drospirenone to increase its bioavailability, and that the micronized drospirenone would absorb with a normal pill, against the teachings of the prior art. The district court analyzed the prior art and determined that micronizing drospirenone was taught, and that using a normal pill would have been obvious to try.

Obzilla sat in at the CAFC too, whispering convincingly in two judges' ears (Mayer & Friedman). Only the sensible sourpuss Judge Newman found the big lug of obviousness stinking up the joint with loose logical connections. But let's not get ahead of the joke with the punch line just yet. First, copious case law.

A patent may not be obtained if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which the subject matter pertains. 35 U.S.C. § 103(a). An obviousness analysis is based on several factual inquiries. A court must examine the scope and content of the prior art, the differences between the prior art and the claims at issue, and the level of ordinary skill in the pertinent art. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). At that point, a court may consider secondary objective evidence of non-obviousness, such as commercial success, long felt but unsolved need, failure of others, and the like. Id.

In KSR, the Supreme Court stated that an invention may be found obvious if it would have been obvious to a person having ordinary skill to try a course of conduct:

When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.

550 U.S. at 421. This approach is consistent with our methodology in In re O'Farrell, 853 F.2d 894 (Fed. Cir. 1988). See Procter & Gamble Co. v Teva Pharms. USA, Inc., 566 F.3d 989, 996-97 (Fed. Cir. 2009); In re Kubin, 561 F.3d 1351, 1359, (Fed. Cir. 2009). O'Farrell observed that most inventions that are obvious were also obvious to try, but found two classes where that rule of thumb did not obtain.

First, an invention would not have been obvious to try when the inventor would have had to try all possibilities in a field unreduced by direction of the prior art. When "what would have been 'obvious to try' would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful" an invention would not have been obvious. O'Farrell, 853 F.2d at 903. This is another way to express the KSR prong requiring the field of search to be among a "finite number of identified" solutions. 550 U.S. at 421; see also Procter & Gamble, 566 F.3d at 996; Kubin, 561 F.3d at 1359. It is also consistent with our interpretation that KSR requires the number of options to be "small or easily traversed." Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008).

Second, an invention is not obvious to try where vague prior art does not guide an inventor toward a particular solution. A finding of obviousness would not obtain where "what was 'obvious to try' was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it." O'Farrell, 853 F.2d at 903. This expresses the same idea as the KSR requirement that the identified solutions be "predictable." 550 U.S. at 421; see also Procter & Gamble, 566 F.3d at 996-97; Kubin, 561 F.3d at 1359-60.

Here's how the panel majority boiled the situation down.

At this point, a person having ordinary skill in the art has reached a crossroads where he must choose between two known options: delivery of micronized drospirenone by a normal pill following the spirorenone analogy in the Krause series, or delivery of drospirenone by an enteric-coated pill following the Nickisch teaching that the drug needs to be protected from the stomach. This is a finite number of identified, predictable solutions. See KSR. 550 U.S. at 421. The prior art would have funneled the formulator toward these two options; he would not have been required to try all possibilities in a field unreduced by the prior art, thus avoiding the first pitfall of O'Farrell, 853 F.2d at 903. Additionally, the prior art was not vague in pointing toward a general approach or area of exploration, but rather guided the formulator precisely to the use of either a normal pill or an enteric-coated pill, thus avoiding the second pitfall of O'Farrell. Id. Because the selection of micronized drospirenone in a normal pill led to the result anticipated by the Krause series, the invention would have been obvious. See KSR, 550 U.S. at 421.

Affirmed.

Every time one reads a Newman dissent, one is left wondering how a decision could have gone any other way. A condescending sneer to her lesser colleagues on the court wears no disguise, only the wispy undergarment of "respectful" dissent. A thing of beauty, Judge Newman's sense of rectitude in disgust. Here we are again.

The evidence showed, without contradiction, that it was known that micronized drospirenone rapidly degraded at the acidity of stomach acid. The evidence showed, without contradiction, that the Bayer scientists working in this field believed that the product required an enteric coating in order to prevent degradation in the stomach, upon ingestion as an oral contraceptive. Yet my colleagues, employing their own expertise, hold that since the scientists working in this field turned out to be mistaken, it would have been obvious that it was not necessary to take steps to prevent acid degradation. The court discounts the testimony of the scientists themselves, ignores the knowledge concerning this product and its instability in acid, ignores the textbook teachings, and finds that this unlikely process obviously should have been tried. That is not the law of obviousness.

The statutory criterion is whether the invention would have been obvious to persons of ordinary skill at the time of the invention, not whether it is sufficiently simple to appear obvious to judges after the discovery is finally made, despite the years of contrary belief among the scientists charged with the project. At the time that the Bayer scientists were attempting to formulate drospirenone as an oral contraceptive, the textbook teaching was that micronizing acid-sensitive products would accelerate their acid-induced degradation. See, e.g., Aulton's Pharmaceutics: The Design and Manufacture of Medicines (advising against micronizing acid-sensitive drugs because it reduces the drug's bioavailability). My colleagues criticize these specialists, and rule that it was nonetheless obvious to conduct experiments that they believed would not work. The court rules that the scientists should have "tried" that which they believed would fail, and that when they eventually did try this unlikely formulation, and it succeeded, it was obvious to do so.

The unusual physiological behavior of drospirenone in the stomach was not known; this knowledge followed as scientific explanation; it did not precede the invention in suit. There was no evidence to reasonably suggest that micronized drospirenone was likely to be usable, with 99+ percent consistency of effectiveness, without any protection from degradation by stomach acid. A usable contraceptive requires virtually complete effectiveness, and the standard confronting the Bayer scientists was high. Unlike the unrelated drugs cited by the panel majority, contraceptives require complete effectiveness. Previously known oral contraceptives such as progesterone and spironolactone are not acid sensitive, and drospirenone presented a highly specific challenge to the formulation scientists. The Bayer scientists believed that the way of avoiding the known acid degradation of drospirenone was to protect it from acid. My colleagues, however, find that it would have been obvious to expose it to acid, although it was not obvious to the scientists working on the project.

"Obviousness" requires that the subject matter was obvious to persons of ordinary skill in the field of the invention. The law does not hold it "obvious to try" experiments that contravene conventional knowledge, and that are not deemed reasonably likely to succeed. The evidence in this case is a better measure of obviousness than is the hindsight science of judges, for the scientists who eventually made this discovery testified, without dispute, that they did not believe an uncoated micronized product would meet the demanding criteria of contraceptive effectiveness. The Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) explained that the standard for "obvious to try" is whether there was a "reasonable expectation of success" at the time. It was undisputed that there was not. It was undisputed that it was not reasonably expected that uncoated micronized drospirenone would be 99+% effective as an oral contraceptive when ingested into the acidic stomach, when it was known to degrade rapidly in acid.

The district court stated that micronization was a "viable" option, and that although success was "uncertain," the invention was obvious to try. However, "viability" is not the standard. "Viability" implies that the experiment may or may not succeed. What the law requires is not guesswork, not dumb luck, but a reasonable degree of predictability of success. My colleagues depart from the statutory standard, in ruling that persons of ordinary skill would have conducted experiments that were expected to fail. Nothing in the prior art teaches the likelihood of success of ingestion of uncoated micronized drospirenone; what is taught is the likelihood of failure.

The invention must be viewed as a whole. With the existing knowledge that drospirenone is both hydrophobic and that it degrades rapidly in acid, and the existing knowledge that micronization, although useful to counteract a drug's hydrophobic properties, renders the drug even more susceptible to acid degradation, it was not shown that a person of ordinary skill in this field would have had a reasonable expectation of achieving complete contraceptive bioavailability and effectiveness with uncoated micronized drospirenone. The contrary view has surfaced only in this litigation-induced argument. The exercise of judicial expertise to override the clear evidence of how persons of skill in this field actually behaved, is inappropriate.

I respectfully dissent.

Posted by Patent Hawk at August 6, 2009 10:24 PM | Prior Art

Comments

I'm surprised that Newman J. did not suggest the obvious, namely, that her brethren judges (Mayer J. & Friedman J.) should resign from the bench so that they can spend the rest of their days better serving mankind by unleashing torrents of scientific papers upon the world.

I mean, heck, these guys are smarter than all the scientists in the world. Everything is obvious to them. Why are we wasting millions of dollars on actual research when they, the CAFC judges could have told us so in the first place without the expensive research?

Oh the humanity. Just imagine how progress could have been so much better promoted if Mayer J. & Friedman J. spent their time revealing the scientifically obvious to us dumb dumbs instead of ruling from the bench on how truly dumb all scientists are for not having seen the obvious. D'oh.

Posted by: step back at August 7, 2009 3:29 AM

Crossing paths:

"...able to fit the teachings of multiple patents together like pieces of a puzzle."

and

"The fact is that one new idea leads to another, that to a third, and so on through a course of time until someone, with whom no one of these ideas was original, combines all together, and produces what is justly called a new invention."

Posted by: breadcrumbs at August 7, 2009 5:20 AM

We need somebody to find a cure for death so we can keep J. Newman forever. A non-obvious cure, of course.

Posted by: don't bother at August 7, 2009 5:49 AM

>A non-obvious cure, of course.

Ah, but in hindsight, perhaps obvious to try.

Posted by: Carl Strathmeyer at August 7, 2009 6:48 AM

Also while we're at it (that is, discussing the most must-have obvious inventions that the resigning CAFC panel members can bestow on mankind thanks to their perspicacious minds), a method of spinning a politician's speech into gold. This will solve the national debt problem and convert political speech into something concrete and useful. --And of course it satisfies the transformation prong of Bilski. More over if the politician belongs to a political party, he's tied to a machine.

Posted by: step back at August 7, 2009 8:12 AM

...same class as perpetual motion machines?

Posted by: breadcrumbs at August 7, 2009 8:38 AM

I'm sorry but from what I can see here there simply wasn't much to say. They had a no doubt rock solid motivation. I'm sure this isn't the first time that a drug previously thought to need some huge coating was instead made in a standard pill form after being micronized. That's hardly a "breakthrough". It is "routine" if anything.

The thing I love about Newman's dissent is where she relies on Bayer's own scientists for some information about what a poshita thought. It's like saying, well, as long as the inventors themselves don't find the invention obvious, then it isn't obvious.

That's not the way things work here irl Newman. I understand the temptation to say such things, but come on, you're supposed to be smarter than that.

One other thing I love is how she accepts, as if there is no problem what so ever, evidence that GENERALLY SPEAKING acid sensitive products should not be micronized. However, were someone presenting evidence that GENERALLY SPEAKING acid sensitive products should not be micronized, she'd say that the reference wasn't specific enough to tell the person of ordinary skill specifically which acid sensitive products were covered by the teaching. All in a days work for a patent protectionist.

And the final thing, she doesn't accept the part on page 7 which is crucial for having found obviousness. With that in hand, the rest is cake. If she was going to dissent, she needs to have dissented against that.

Specifically:

"It was undisputed that there was not. It was undisputed that it was not reasonably expected that uncoated micronized drospirenone would be 99+% effective as an oral contraceptive when ingested into the acidic stomach, when it was known to degrade rapidly in acid."

That is wrong. That is what the analysis on page 7 addresses. Micronized drospirenone was not known to degrade rapidly in acid. There was a general teaching that suggested it might be, and there was a contrary general teaching suggesting for one of ordinary skill to have performed the tests to find out. See page 7.

"My colleagues depart from the statutory standard, in ruling that persons of ordinary skill would have conducted experiments that were expected to fail."

They weren't "expected" to fail. There was a general teaching that suggested they might fail. Newman draws too much about failure from the reference.

Posted by: 6 at August 7, 2009 2:07 PM

6,

Spoken like a true ivory-tower examiner.
In the real world, most new experiments do fail.

Posted by: step back at August 7, 2009 4:50 PM

Thanks to all for heaping on ridicule that the KSR decision deserves. "Pieces of a puzzle" my ass.

Posted by: John at August 8, 2009 3:11 AM

Ridicule doesn't help. Those in power will not respond to ridicule in a positive manner. At the end of the day, we need to get the judges to see the errors of their ways.

The Supreme Court justices were wrong in Benson (v. Gotchalk), wrong in Anderson Black Rock Paving and wrong (to an extent) in KSR. But we as patent practitioners are also wrong. Wrong to rigidly read into KSR more than is there. KSR has a unique fact pattern. One should read and re-read KSR many times before jumping to foregone conclusions. Everything in the law is a double edged sword. What's "flexible" for the goose is new ways "to bend" the argument for the gander. Flexible cuts both ways. Learn to be flexible.

Posted by: step back at August 8, 2009 9:22 AM

"Every time one reads a Newman dissent, one is left wondering how a decision could have gone any other way."

I agree

Posted by: John Prosecutor at August 8, 2009 1:46 PM

But why is she on the dissent so often when it seems to count?

Her writing is clear and logical, but why does is not convince her peers?

Posted by: breadcrumbs at August 8, 2009 6:36 PM

"Her writing is clear and logical"
Really? If it is so clear and logical, can you even figure out from the dissent the grounds on which she would reverse the district court? Was there clear error in one of the judge's factfindings? Or was there an identifiable mistake of law? It looks to me like a walk through a bunch of marginally relevant facts. Is her only point that the district court's finding of viability was legally insufficient to reach KSR's requirement of a reasonable expectation of success? That seems like a difference without a distinction. Or is she saying that such finding was clear error? Maybe if her writing were clear and logical, I could figure that out.

Judge Newman is capable of much more. If this case should have been reversed, I suspect the dissent would have been much harder hitting. A flabby opinion like this makes me think there was nothing there, and she's just pining for the fjords.

The best advice you can get out this opinion is if you are a patentee with a shaky obviousness issue, do not try validity to the bench! A jury would have been more sympathetic to the invention story.

Posted by: Not much at August 8, 2009 8:48 PM

"but why does it not convince her peers?"

Humans can be irrational and insane.
Judges are human.
Ergo ...

Posted by: step back at August 8, 2009 11:20 PM

"the district court's finding of viability was legally insufficient to reach KSR's requirement of a reasonable expectation of success? That seems like a difference without a distinction."

not much, your statement provides much more than you think.

Do you understand law?

Posted by: breadcrumbs at August 9, 2009 6:25 AM

breadcrumbs--I don't think you are suggesting that viable does not mean reasonable chance of success. That's actually one of the definitions of viability in Merriam-Webster. So what is your position? That the finding of reasonable chance of success was clear error, or that the finding was insufficient to support the ultimate legal conclusion? And why?

Posted by: Not much at August 9, 2009 12:24 PM

Let's start with:

"The evidence showed, without contradiction, that it was known that micronized drospirenone rapidly degraded at the acidity of stomach acid."

"The evidence showed, without contradiction, that the Bayer scientists working in this field believed that the product required an enteric coating in order to prevent degradation in the stomach, upon ingestion as an oral contraceptive."

"The court discounts the testimony of the scientists themselves, ignores the knowledge concerning this product and its instability in acid,

IGNORES THE TEXTBOOK TEACHINGS,

and finds that this unlikely process obviously should have been tried. That is not the law of obviousness." (my emphasis)

I am interested in how you think that teaching away can lead to your "viability" and then the jump from "viability" to reasonable expectation of success (which is more stringent than reasonable CHANCE of success - chance is not the proper framework).

Can you explain why you think this is a difference without a distinction?

Posted by: breadcrumbs at August 9, 2009 7:18 PM

"I am interested in how you think that teaching away can lead to your "viability" and then the jump from "viability" to reasonable expectation of success "

Have you even bothered to read page 7 or the corresponding references? I'm betting not. There is a "teaching away" later on, but it is balanced by another teaching, a teaching to go find out whether or not the teaching away in fact applied to this particular scenario. And thus motivated/instructed to find that out, the person of ordinary skill then goes and finds out and then knows that GENERAL/TEXTBOOK "teaching away" was bogus. Thus having found that out to be false, he proceeds with his experimental design.

The teaching away sword can cut both ways. It'll give you a glimmer of hope, until you find out that one of ordinary skill was, in fact, told to go and find out if that applies to the situation at hand or not. Then, after having noticed that POSHITA was motivated to find that out, your teaching away vanishes to the four winds.

I see this kind of thing every now and again. Usually attorneys just go along with an amendment. These people fought. The other side was just lucky that it had 2 judges who are reasonable, and pay attention. It is as if Newman just straight up ignored the teachings on page 7. I'd love to have heard her address them on the merits and tell us what they suggest. And then when her "logical" writing draws the "noose around her neck" (or whatever as noise loves to say) then she can attempt to square ALL of the facts together, instead of just ignoring those she finds inconvienent or uninteresting.

Posted by: 6000 at August 10, 2009 1:01 AM

From Patent Docs ( http://www.patentdocs.org/2009/08/bayer-schering-pharma-ag-v-barr-laboratories-inc-fed-cir-2009.html ):

"This is not on its face an unreasonable assessment of the prior art. However, like the District Court, it ignores, indeed it disregards, the affirmative evidence of what did happen in favor of the majority's reconstruction of what could have happened."

and

"Judge Newman is too polite to say it, but decisions such as these are not only contrary to the statute, but are a form of judicial tyranny, where the law is what the court says it is (despite undisputed evidence to the contrary and a statutory standard for assessing such evidence). "

I'm not sure how balanced the teaching away arguments are if the fact situation in the case was indeed "without contradiction".

Chance (as opposed to expectation)... what could have happened (as opposed to what undisputedly had happened)... The slippery slope seems to be fully engaged.

Posted by: breadcrumbs at August 10, 2009 5:31 AM

6,

I think your comment "Have you even bothered to read page 7 or the corresponding references? I'm betting not." is a bit disingenuous.

How many of the 89 NPL's, 20 foreign references, and 7 affidavits (not withstanding the uncounted US references) located in the file wrapper have you "bothered" to read?

Where should I place that wager?

Posted by: breadcrumbs at August 10, 2009 6:01 AM

"This is not on its face an unreasonable assessment of the prior art. However, like the District Court, it ignores, indeed it disregards, the affirmative evidence of what did happen in favor of the majority's reconstruction of what could have happened.""

The problem in that little scenario is a rather large one. The researchers didn't necessarily have all the prior art in front of them. Especially the references cited on page 7. POSHITA SEES EVERYTHING NOT JUST YOUR ONE TEXTBOOK. If they had seen everything then they may very well have not taken a few years to figure this out. They would have performed one (rather simple iirc) experiment to determine how fast the stuff breaks down in stomach acid, and, after having found that, proceeded to make the drug in that form.

"Chance (as opposed to expectation)... what could have happened (as opposed to what undisputedly had happened)"

Not so much "chance" but "what one would expect POSHITA to do according to the teachings in front of you". The bottom line is that the scientists apparently didn't have a reason to run the experiment because they thought along the lines of a single textbook (or the general knowledge in the art). If they'd have had POSHITA's omnicience and if they understood the teachings, then the fact that they should go check out that general assumption for their specific case would have popped into their minds a mite sooner it does seem.

I read the ones that have been brought to my attention as being particularly relevant. The ones on page 7 are relevant. If the other million are too, then cite them as supporting your side, or another side that weighs against 103 being applied.

Bottom line, if she's not going to clearly erroneous the findings on page 7 or the legal determination based thereon then she may as well hang her hat up on this one, because that is where the whole case rests.

Posted by: 6000 at August 10, 2009 6:42 AM

6,

Even granted that neither of us have waded through the vast amount of background on this case, you have made an error in your logic and one of your prime pillars is built on sand.

You state "The problem in that little scenario is a rather large one. The researchers didn't necessarily have all the prior art in front of them. Especially the references cited on page 7."


The references on page 7: "The court found that a person having ordinary skill in the art would have considered the Krause I, II, and III studies’ results that spirorenone though acid-sensitive would nevertheless absorb in vivo because drospirenone is closely related to spirorenone."

From Patent Docs (btw, disagreeing with the assumption of the district court): “The Court found that spirenone and drospirenone were related "as close[ly] as fraternal twins" and thus imputed the behavior of spirenone to drospirenone despite the evidence that they differed at least in their in vitro properties.”

From the testimony:
“These studies, Krause I, II, and III, included the knowledge that drospirenone was a metabolite of spirorenone. Tack decided, however, that these in vivo studies garnered little information on the practice of drospirenone in vivo.”

“Tack tested the stability of drospirenone in acid at pH 1 to simulate the conditions of the stomach. He found that after 10 minutes, 21% of the drospirenone had isomerized in the acid, and after 45 minutes, half had isomerized. He came to a critical conclusion:
If the results obtained in vitro are applied to in vivo conditions, it can be presumed that, with an assumed gastric juice volume of 100ml, the majority of the dose (solubility of drospirenone 5-10 mg/l) passes into solution during passage through the stomach and consequently undergoes rapid isomerization. A clear reduction in the bioavailability of the unchanged active substance is to be expected as a result.
The planned studies on the progestogenic efficacy of [drospirenone] should therefore be performed with an enteric-coated formulation.”

Further, Patent Docs take on the case is that it is not PHOSITA that is being used, but rather, the Judge's position, whom clearly is NOT PHOSITA.

I sincerely hope that you are not a betting man.

Posted by: breadcrumbs at August 10, 2009 8:25 AM

breadcrumbs,

You can bet (and win) that 6 will be wrong. Always.

Posted by: Noise above Law at August 10, 2009 8:35 AM

"Patent Docs take on the case"

Has there ever been a biotech patent that Kevin Noonan thought was correctly invalidated?

Posted by: Just Asking at August 10, 2009 10:58 AM

"You can bet (and win) that 6 will be wrong. Always."

Well, you lost this one. The majority nailed it while Newman got bogged down in the swamp of secondary factors and red herrings. As the majority understands, re-formulating an old oral medicine is not cutting edge rocket science. It never is. And given the limited number of industry standard options in this case (two), it should (and does) take a lot more than a single reference "suggesting" that one option may not work to render an invention incorporating that implementation non-obvious.

Newman complains that obviousness requires more than "dumb luck." But she needs to read KSR again. Dumb luck is perfectly acceptable when the number of known options is very small. Again, this is as it should be. One does, in fact, have a "reasonable expectation of success" that a flipped penny will come up heads. That's what happened here. That's not a patent-worthy invention.

Posted by: Just Saying at August 10, 2009 11:11 AM

"One does, in fact, have a "reasonable expectation of success" that a flipped penny will come up heads."

I would think that a reasonable expectation of success would be greater than 50%, as the coin flip is the epitome of chance with absolutely no reasonable expectation of success - in the smallest number of choices, you cannot guarentee either.

As "obvious to try" requires a result that is reasonably predictable and the 50-50 split is anything but, perhaps we all need to re-read KSR again...

Posted by: a new penny at August 10, 2009 12:43 PM

"I would think that a reasonable expectation of success would be greater than 50%, as the coin flip is the epitome of chance with absolutely no reasonable expectation of success "

The chance of success is very close to 50%. That sounds pretty reasonable to me, especially if the penalty for "failing" is minimal or non-existent.

And if you want to get "technical" about it, you can probably find some study showing that with all other conditions normalized the odds do in fact favor one side or the other for a particular coin.

Posted by: Just Saying at August 10, 2009 12:56 PM

And just to follow up on that thought, if the odds say that for a particular coin "heads" comes up 52% of the time, does that mean a "tails" result is "surprising" or "unexpected"?

Posted by: Just Saying at August 10, 2009 1:00 PM

"And if you want to get "technical" about it, you can probably find some study showing that with all other conditions normalized the odds do in fact favor one side or the other for a particular coin."

Actually the meaning of the phrase will do just perfectly - it's that very meaning that nullifies your position and is the reason why "coin flip" is the epitome of chance.


"The chance of success is very close to 50%. That sounds pretty reasonable to me,..."
Not sure why you are conflating chance with expectation here, or where you are going with this thought. Given only two alternatives, for you to take 50% as reasonable is indeed questionable. Vegas loves people like you.

Posted by: a new penny at August 10, 2009 1:57 PM

"for you to take 50% as reasonable is indeed questionable. Vegas loves people like you."

Again, it depends on my understanding of the value of the bet, doesn't it? i.e., what do I get if my choice is correct versus what do I get if my choice is incorrect. Do you think Bayer was gambling the fate of their company on the outcome of their chosen formulation?

Under certain circumstances, a 10% likelihood of success could be very reasonable excuse for going forward, if the costs of doing so are low (e.g., if there are only a minute number of choices and choosing one option does not preclude testing the other option at the same time or late) and if the benefits of a success are strongly desired.

Posted by: Just Saying at August 10, 2009 2:44 PM

"Again, it depends on my understanding of the value of the bet, doesn't it?"

Actually no it doesn't - But what happens in Vegas, stays in Vegas.

Posted by: a new penny at August 10, 2009 4:44 PM

Just saying,

Interesting comment about under some circumstances.

I think you are correct in that in some circumstances and for some individuals, even 10% (and I would posit in some circumstances a less than 1%) likelihood of success would be considered "reasonable" (by that person) for moving forward. But how is that tied to a PHOSITA? Likewise, how is "strong desire" tied to a PHOSITA.

Perseverance and drive are indeed admirable qualities and I imagine that, like ingenuity and common sense, the PHOSITA must have some degree of these qualities. I do struggle with how much of these qualities are and can be equated with "Ordinary Skill". I then struggle with the attribution of these qualities with the last line of 103(a), as it seems that the application of these qualities seemingly impacts the "manner" in which inventions are made, rather than the inventions themselves.

Posted by: breadcrumbs at August 11, 2009 3:44 AM

Man you guys are crazy. Bread I am a betting man, but only on a sure thing. Unless I'm just looking to have some "fun" in vegas. I.e. just taking the thrill of the bet.

My buddies hate it when I offer a bet because they know that when I bet I only bet when there is a miniscule chance of losing.

Posted by: 6000 at August 11, 2009 11:02 AM

Quite the interesting conversation, regarding the coin flip. Could it be that KSR potentially conflicts with "the manner" recited in 103?

Posted by: Jules at August 11, 2009 11:31 AM

Dear Just Asking:

In answer to your question, Pfizer v. Apotex was correctly decided because the patentee claimed the composition when the unexpected advantages related to the method of making. So they were precluded from asserting (or having the court credit) these advantages when arguing non-obviousness.

But thanks for giving me the opportunity to clarify.

Posted by: Kevin E. Noonan at August 11, 2009 2:25 PM

6 said,

"after having noticed that POSHITA was motivated to find that out"

and

"POSHITA SEES EVERYTHING NOT JUST YOUR ONE TEXTBOOK"

poSHITa LOL

i c wat u dit ter

It's PHOSITA, noobtard.

Posted by: broje at August 14, 2009 12:36 PM