Is Everything Obvious?

    By Kevin E. Noonan --

Two pronouncements, one from the Supreme Court and the other from the Federal Circuit, portend the parlous state that could await American innovation should judges come to believe that that their judgment is as sound as that of actual innovators.

From the Federal Circuit's In re Kubin decision (citing In re O'Farrell):

Specifically, this court observed that an obviousness finding was appropriate where the prior art "contained detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful."  853 F.2d at 902 (emphasis added).  Responding to concerns about uncertainty in the prior art influencing the purported success of the claimed combination, this court stated:  "[o]bviousness does not require absolute predictability of success . . . all that is required is a reasonable expectation of success."  Id. at 903-04 (emphasis added).  The Supreme Court in KSR reinvigorated this perceptive analysis.

And, of course, from the Supreme Court in KSR Int'l Co. v. Teleflex Inc.:

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.

The combination of these sentiments leave open the question:  what isn't obvious?  We know that the Supreme Court has never disclaimed the discredited "flash of genius" requirement from Cuno Engineering Corp. v. Automatic Devices Corp., despite Congressional abrogation in the last sentence of 35 U.S.C. § 103:  "Patentability shall not be negatived by the manner in which the invention is made."  Indeed, the Court opined in Graham v. John Deere Co. that Congress merely intended to codify the Court's own obviousness jurisprudence.  Fortunately not, since even members of the Court had come to recognize, in the years just prior to the 1952 Act, that the Court's overt hostility to patents had become extreme:  Justice Robert Jackson was moved to remark that the remedy for "bad patents" (sound familiar?) was not "an equally strong passion in this Court for striking them down so that the only patent that is valid is one which this Court has not been able to get its hands on."  Jungersen v. Ostby & Barton Co., 335 U.S. 560, 572 (1949).

We again seem to be in a period, as in the 1940's, of frank hostility to patents and patent law from the Supreme Court.  Indeed, if the following quote:

The design of the patent laws is to reward those who make some substantial discovery or invention, which adds to our knowledge and makes a step in advance in the useful arts.  It was never their object to grant a monopoly for every trifling device, every shadow of a shade of an idea, which would naturally and spontaneously occur to any skilled mechanic or operator in the ordinary progress of manufactures.  Such an indiscriminate creation of exclusive privileges tends rather to obstruct that to stimulate invention.  It creates a class of speculative schemers who make it their business to watch the advancing wave of improvement, and gather its foam in the form of patented monopolies, which enable them to lay a heavy tax upon the industry of the country, without contributing anything to the real advancement of the arts.  It embarrasses the honest pursuit of business with fears and apprehensions of concealed liens and unknown liabilities to lawsuits and vexatious accountings for profits made in good faith.

(from Atlantic Works v. Brady, 107 U.S. 192, 200 (1882)) appeared in the KSR decision (or, for that matter, on the Coalition for Patent Fairness' website), would anyone have been surprised or thought it out of place?

The difference, of course, is that today we have the Court of Appeals for the Federal Circuit, capable (but lately seemingly unwilling) to provide legal analysis to assist the Court in its heretofore infrequent forays into waters it rarely, uncomfortably, and maladroitly treads.  However, as the CAFC has shown in Kubin, and earlier in Pfizer, Inc. v. Apotex, Inc., Aventis Pharma Deutschland GmbH v. Lupin, Ltd., and Pharmastem Therapeutics, Inc. v. Viacell, Inc., the KSR influence is strong on the Court.  All is not lost, of course:  there have been plenty of decisions since KSR where the Federal Circuit upheld the non-obviousness of pharmaceutical patents, including Sanofi-Synthelabo v. Apotex, Inc., Eisai Co. v. Dr. Reddy's Laboratories, Inc., Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., Forest Labs, Inc. v. Ivax Pharm., Inc., and Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd.  However, in every case, the bases for so holding has been the application of traditional principles of chemical structural non-obviousness ("structure, structure, structure" according to Judge Rader) and none of these cases has focused on the more liberal "obvious to try" standard enunciated in In re Kubin.

The Federal Circuit's Kubin decision (and to a lesser extent, the Court's disregard of the Graham secondary indicia of non-obviousness in the Pharmastem decision) raises the legitimate issue of what won't be obvious by the application of the Kubin doctrine.  For example, an analogy could be drawn between the way the court applied obviousness law to the facts in Kubin and the situation for most monoclonal antibody claims.  Just like the p38/NAIL protein in Kubin, antigens (particularly antigens to pathogens) are frequently known in the art.  Indeed, the existence in the art of such pathogen-derived antigens would presumably engender an even greater motivation for the skilled worker to make an antibody than the existence of p38 in the prior art motivated Kubin to isolate NAIL cDNA.  As in Kubin, the methods for making monoclonal antibodies are just as established (perhaps even more so, having been judicially recognized as "extensive, but routine" in In re Wands and Noelle v. Lederman), and obtaining a monoclonal antibody just as "predictable" (perhaps more so) as obtaining a cDNA in Kubin.  And the final similarity is that the structure of the antibody is equally as unknown in the prior art (and unrelated to the structure of the antigen) as is the protein structure to the nucleic acid comprising the gene encoding it.  (It is probably a wash that the genetic code provides some means for determining "a" -- as opposed to "the" -- nucleotide sequence encoding a known amino acid sequence, versus the binding affinity between an antibody and its cognate antigenic epitope, since neither the identity of the epitope -- for antibodies -- nor the complete amino acid sequence -- for genes -- is typically known.)  Thus, it can fairly be asked whether claims to a monoclonal antibody are now prima facie obvious under the Kubin doctrine.

Indeed, something of this sort has already happened, in the Federal Circuit's In re Tzipori decision.  From a Patent Docs post on that case:

While the CAFC conceded that Tzipori had established that Krivan did not disclose monoclonal or humanized antibodies to SLT-II, the Court noted that Queen disclosed a method of making humanized antibodies and Perara disclosed the manufacture of hybridomas that produce monoclonal antibodies.

Taken to its extreme, everything thus becomes obvious.

In the last century, Learned Hand (at right; a jurist whose insight and intellect were indeed what current members of this or any Court should hope they would possess) recognized the problem and its rational solution:

The test laid down [in 35 U.S.C. § 103] is indeed misty enough.  It directs us to surmise what was the range of ingenuity of a person "having ordinary skill" in an "art" with which we are totally unfamiliar; and we do not see how such a standard can be applied at all except by recourse to the earlier work in the art, and to the general history of the means available at the time.  To judge on our own that this or that new assemblage of old factors was, or was not, "obvious" is to substitute our ignorance for the acquaintance with the subject of those who were familiar with it.  Reiner v. I. Leon Co., 285 F.2d 501 (2d Cir. 1960)

Courts, made up of laymen as they must be, are likely either to underrate, or to overrate, the difficulties in making new and profitable discoveries in fields with which they cannot be familiar; and so far as it is available, they had best appraise the originality involved by the circumstance which preceded, attended and succeeded the appearance of the invention.  Safety Car Heat & Light Co. v. General Electric Co., 155 F.2d 937 (2d Cir. 1946).

Hat tip to Bob Harmon for the Learned Hand quotes.

Antibody image: Tom Vickers, Wikipedia Commons

Comments

[Learned Hand Groupie]

Thanks for the (depressing but unfortunately I believe accurate) analysis. These are indeed dark times for people and companies who depend on the strength and predictability of patent law.

Aside: I love Learned Hand's opinions, and have searched periodically since law school for a reference that either collects his opinions or purports to teach how to write as he did. If anyone knows of a good reference, I would deeply appreciate hearing about it here.

[Kevin E. Noonan]

Dear Groupie:

I don't think anyone can teach any of us how to write like Judge Hand. Bob Harmon's book, Harmon on Patents: Black Letter Law and Commentary (BNA) contains a great many Hand quotes relating to patent law.

Thanks for the comment

[Bill Piscuitowicz]

Since we have Sambrook and the human genome sequence, no DNA-based therapeutic will ever be patentable again. Sambrook tells us how to clone everything (according to the CAFC, anyway, which is a totally different issue), and also tells us how to assay for activity.

No more biotech patents. Let's shut it all down, boys. Nothing to see here.

Now we can await the brilliance of the CAFC to tell us how the decisions in this area "promote the progress of science".

Not holding my breath.

[EG]

Kevin,

Nice post on what Kubin and KSR mean. As far as I'm concerned, SCOTUS has created utter chaos in its wake regarding how to evaluate patentability under 35 USC 103, and the Federal Circuit opinions reflect that "chaos." If I had the time (may be I will later), I could write an interesting article on the "chaos" created by SCOTUS in the wake of KSR, eBay and MedImune

BTW, Learned Hand was one the great judges who should have been (but for politics) elevated to the SCOTUS bench. If only we had some Learned Hands on SCOTUS now. Hand at least understood how patent law worked. For example, my dad always referred to Hand's opinion in Dewey & Almy Chemical Co. v. Mimex Co., 124 F.2d 986, 989 (2d Cir. 1942) for a crystal clear definition of when a reference anticipates, and quoted by the Federal Circuit in the 2002 case of Elan Pharmaceuticals v. Mayo Foundation (which even the Federal Circuit said couldn't be improved upon):

"No doctrine of the patent law is better established than that a prior patent or other publication to be an anticipation must bear within its four corners adequate directions for the practice of the patent invalidated. If the earlier disclosure offers no more than a starting point for further experiments, if its teaching will sometimes succeed and sometimes fail, if it does not inform the art without more how to practice the new invention, it has not correspondingly enriched the store of common knowledge, and it is not an anticipation."

In Mimex, Hand also stated that there was not anticipation because the prior art reference needed to "hit the target" but did not.

[Charles R. Nold]

I tell my corporate clients they don't need R&D departments and to send all their problems to the Patent Office, since everything is obvious to them.

[Keep It Real]

My biotech clients who make real products and who demonstrate positive results with those products are still getting claims issued to methods and compositions drawn to those products.

Kubin is not a lesson about the obviousness of biotech inventions. Kubin is a lesson about poor claim drafting, poor prosecution strategy, and poor trial strategy.

Kubin could have gotten some decent claims but Kubin got greedy.

[Barry Elledge]

Your post well expresses the misgivings I've had since KSR, and which were regretably vindicated in Kubin. I concur in the suggestion that Kubin ignores the last sentence of s. 103; the fact that the invention as claimed by Kubin was obtained by applying known techniques to the problem rather than by a sudden insight should have no bearing on patentability. If the hard work of science is not worthy of a patent, then biopharma companies will have no incentive to engage in such research, nor to commercialize the results. And how many Nobel and similar prizes have been given for groundbreaking research which obtained its results using known techniques?

[Kevin E. Noonan]

Dear Keep:

I would have had much less of a problem with the court's decision in Kubin if they had stated an opinion as succinctly as yours. Indeed, they could have addressed the "greedy" issue more directly using the written description rejections, and at the same time weighed in on how the Office was applying the standard that was changed last March (remember, in Rochester and Enzo and Noelle the court seemed to approve of the old (2001) way the Office was applying the written description requirement, and there was some sharp questioning from the bench at oral argument regarding the apparent change in standard, particularly as it related to Kubin's claims).

But that's not what they did. They threw out the chemical obviousness approach, and implemented an "obvious to try" approach where what was obvious was trying the method. Particularly since I think the court missed a critical factual distinction between the case they had and the case the Board said they had, this is regretable.

I don't mean to imply that nothing is now patentable in biotech; I just think that it is presumably obvious unless proven otherwise, in contradiction to the statute. If Congress wanted to enact real patent reform, they would overrule this "uber-invention" standard the Supreme Court imposes and dare the court to invalidate it. Just a pipe dream, I guess.

Thanks for the comment.

[6]

Hey Kev, sorry I haven't had time to revist in detail the details of the Kubin facts, I've been very much so occupied with other forms of leisure. It is not forgotten however.

In any event, turning away from the facts and towards the legal determination made on just the facts presented before the appellate panel, I can tell that you are having a hard time digesting the basis of the reasoning in the recent decisions. You ask, "what isn't obvious?" under these standards. Well, I can tell you some things that are not obvious. Things where there is no motivation to combine, things where there is no roadmap to a reasonable expectation of success, and similar things which run counter to the reasoning put forth by the courts. A big one is technology which was not even enabled as of the patent apps filing, but was only partially enabled, and the rest of the enablement was provided by the applicant. These are the kinds of categories which the everyman considers to not be obvious, and there appears no need for the judicial branch to needlessly complicate matters with ridiculous methodologies of determining obviousness, when the statute is clear as day.

Either way, as one who has viewed the statute from much the same perspective as the current interpretation of the law has been updated to reflect, I can tell you that it is my belief that the law has finally been set some kind of straight. It is only those without the ability to set aside and disregard bogus previous caselaw, and judgements on the matter and look at the statute as a whole that have real trouble with it. I'm sure you'll pick it up soon enough.

I should mention that the legal determination of obviousness is much like the calls an umpire makes in baseball. There are three common sayings as to how calls are made by umpires: "I call em like I see em" "I call em like they are" and "There ain't nothing till I call it". Though there is usually only one that is professed by a certain individual umpire, they may as well all be true for all umpires. They all call em how they see em, they all call em how they are (percieved by them), and there is nothing till they call it. In just the same manner with obviousness, the judge or examiner holds the power just as the umpire does.

[Kevin E. Noonan]

Dear 6:

Your comment begs for the snappy comeback, something like "youth, ignorance and arrogance are an ugly combination."

But we don't do that here, so I'll try to answer the affirmative statements behind the triple threat that is 6.

I'm not really having a hard time figuring out what the court said, as you no doubt appreciate. I pointed out in this post two things: first, that the Kubin decision, and the reasoning behind it, have consequences that go beyond the decision itself; and second, that these consequences are not required by law or policy, and are in my opinion not good things.

It is easy to criticize as "ridiculous" things with which we don't agree; my point in this and earlier posts was to show the benefits of the Lourie approach and the drawbacks of the Kubin/Rader approach (one that in my view is not mandated by KSR). The perspective of the everyman is not very helpful in some arts, which is why he or she isn't the standard; that would be the person of ordinary skill in the art.

Logically, of course, the problem is with Section 103, which was left open to court interpretation in the 1952 Act. Real patent reform would be for Congress to send a strong "thou shalt not" (as in, stifle innovation by overly stringent obviousness tests) to the court and see whether it tries to say such a change is unconstitutional. Another would be to implement a utility model system that does not consider obviousness as a requirement, but has more limited scope of protection that is obtained more quickly.

Ultimately, as was pointed out by the Learned Hand quotes, someone has to "make the call." In some arts, that (for now) is you, while it ultimately is a judge at some level of the system. By posting as I have, maybe someone will consider the consequences of what Kubin stands for, and come up with a better way of handling the question. You never know.

Thanks for the comment.

[6]

"I'm not really having a hard time figuring out what the court said, as you no doubt appreciate."

Then why lead with "Is everything obvious?" Perhaps I took a rhetorical question for a real one. My bad.

"I'm not really having a hard time figuring out what the court said, as you no doubt appreciate. "

I never implied that you had a hard time figuring out what the court said, I said that I could tell that you're having a tough time with the basis of the reasoning behind it.

"and second, that these consequences are not required by law or policy, and are in my opinion not good things."

Ah, but they are required by law and policy. From this simple statement it becomes crystal clear that I was I was right in determining that you're having a hard time digesting the basis of the reasoning.

As to the youth, certainly, as to the arrogance, certainly (how else to get chics in today's city? :( ), but as to the ignorance idk about the relevance of that one even if, relative to yourself and others like you it may be true. I can read the statute just as well as you my friend, and if you were anything like the legions of other mindless attorneys droning around pre-KSR pretending that what the CAFC laid down years before was some kind of be all end all, then I can read a whole lot better than you, and that trumps any of the rest of the knowledge you'll ever amass on the subject. Period. Every time. Well, when it is combined with persuasion anyway. And that isn't arrogant for me to say that. It's fact, and I'm doing you a favor letting you in on it.

"The perspective of the everyman is not very helpful in some arts, which is why he or she isn't the standard; that would be the person of ordinary skill in the art."

It appears you believe that I'm trying to equate what the everyman believes the statute says with what is obvious to one of ordinary skill in a certain art. I'll pretend that this is not the case since you obviously would not make such a mistake, right? What I'm discussing here is the everyman's interpretation of the statute itself. Not of what is obvious to the everyman.

The perspective of the the everyman is always helpful when determining what the statute itself says. You have to do this before you go off applying it, because this is what a court will do. It just so happens that determining what the statute itself says settles most disputes on obviousness before they even arise. And that is where the everyman shines.

I wish I could explain this to you better, but it is as if the two questions "what does the everyman interpret the statute 103 to say" and "what is obvious to one of ordinary skill" (as with the later being taken in a vacuum) are as different as night is from day, but properly deciding the first question renders the second question less important. In a way. It is kind of like where you have to consider the claim as a whole, you have to consider the statute as a whole, and when you do that the entirety of the inquiry into "obvious to a person of ordinary skill in the art" becomes a mere sideshow to the main attraction of the statute as a whole.

[Kevin E. Noonan]

Dear 6:

I suppose it would have been clearer if the title was "Have recent court decisions expanded the scope of obviousness so that it encompasses non-obvious subject matter," but that seemed a little wordy.

It isn't whether either of us can read the statute, and what you think (outside the small world of the inventors whose applications you examine) or I think isn't the point. "Everyman's" interpretation of the statute isn't the point, either. The point is: 1) what did Congress intend; 2) is it constitutional; and 3) are the courts properly interpreting the statute consistent with the first two? Period. Every time. I think you'd be surprised if you asked a judge whether he was interpreting a statute using your "everyman" standard.

Actually, the statute "as a whole" says something that, if effectuated properly by the Supreme Court would solve most of these issues. "Patentability shall not be negatived by the manner in which an invention is made." Try reconciling that statement with Kubin.

I regret that your experience (coupled with your other traits previously discussed) makes you think that what you think or what I think is what's important.

Thanks for the comment.

[6]

"I think you'd be surprised if you asked a judge whether he was interpreting a statute using your "everyman" standard."

I don't think so, from what I've read of the USSC jurisprudence it seems to be all too common, and it has been reflected in what I've seen inside courtrooms. Little though that may be, and limited to non-patent matters though that may be.

"The point is: 1) what did Congress intend; 2) is it constitutional;"

The answer to that is very simple my friend. And that is a yes on both accounts. It is on its face what they intended. No deeper analysis is called for that I can see, sans agenda to make things nonobvious that really aren't.

""Patentability shall not be negatived by the manner in which an invention is made." Try reconciling that statement with Kubin."

First of it is "was made", as in "Patentability shall not be negatived by the manner in which the invention was made." But hey man, I would totally be on your side for that one if it weren't for the fact that the CAFC used a method completely different than the one Kubin used in his app to invalidate his app. For instance had the exact method that Kubin used been found in the prior art and applied against the app I would totally be down with your problem with the ruling, but since it's a totally different method utilized for rejection the court did not negative patentability by the manner in which the invention was made, they negatived patentability by a different manner in which the invention could (arguably) be made. And for the small fact that it is widely accepted everywhere (even by the everyman so I hear) that congress intended that line to be against negativing patentability because of such things as drunkenness at the time of invention etc. And I think the USSC did ok with interpreting that line.

"I regret that your experience (coupled with your other traits previously discussed) makes you think that what you think or what I think is what's important."

Don't regret that, certainly what you think is important, at least to your clients. And certainly what I think is important, at least to my applicants.

[Kevin E. Noonan]

Dear 6:

"Drunkenness?" I think not. But funny, I admit.

Thanks for the chuckle.