April 3, 2009
Marek Kubin and Raymond Goodwin sought "a claim to a classic biotechnology invention - the isolation and sequencing of a human gene that encodes a particular domain of a protein." The BPAI found it obvious. On appeal, the CAFC wound back the clock to an earlier precedent of "obvious to try" that will march through time. The crucial inquiry: how good a pointer was the prior art?
In re Marek Z. Kubin and Raymond G. Goodwin (CAFC 2008-1184) precedential
Obviousness is a question of law based on underlying findings of fact. An analysis of obviousness must be based on several factual inquiries: (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the art at the time the invention was made; and (4) objective evidence of nonobviousness, if any. See Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). The teachings of a prior art reference are underlying factual questions in the obviousness inquiry. See Para-Ordnance Mfg., Inc. v. SGS Imp. Int'l, Inc., 73 F.3d 1085, 1088 (Fed. Cir. 1995).
As a factual matter, the Board concluded that appellants' methodology of isolating NAIL DNA was essentially the same as the methodologies and teachings of Valiante and Sambrook. Appellants charge that the record does not contain substantial evidence to support this Board conclusion.
A fairly common mistake, however odd, is a disconnect between what the applicant thought he claimed and what he actually claimed. It happened here. The applicants argued about the process of DNA cloning, whereas the claimed invention went to a gene sequence. Anyway, Kubin and Goodwin admitted in their disclosure they used "standard biochemical methods," so the argument was spurious.
Harkening back to last week's ruling In re Gleave, discovery of utility provides no basis for patentability.
See, e.g., Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249 (1945) ("It is not invention to perceive that the product which others had discovered had qualities they failed to detect."); In re Wiseman, 596 F.2d 1019, 1023 (CCPA 1979) (rejecting the notion that "a structure suggested by the prior art, and, hence, potentially in the possession of the public, is patentable . . . because it also possesses an inherent, but hitherto unknown, function which [patentees] claim to have discovered. This is not the law. A patent on such a structure would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art.").
The Supreme Court in KSR explicitly rejected CAFC precedent in Deuel dismissing "obvious to try" as a patentability evaluation criterion.
The Supreme Court repudiated as "error" the Deuel restriction on the ability of a skilled artisan to combine elements within the scope of the prior art:
The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was "obvious to try." 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.
KSR, 550 U.S. at 421 (internal citation omitted) (emphasis added).
Repudiation of Deuel by the Supreme Court wound the CAFC clock back to O'Farrell. "Obvious to try" is calibrated by the degree that there was a vector of prior art pointing the way. For an established art area, something is not obvious to try if the prior gave "no direction." For a new technology, if the prior art gives "only general guidance," a specific solution would not be obvious to try.
The Supreme Court's admonition against a formalistic approach to obviousness in this context actually resurrects this court's own wisdom in In re O'Farrell, which predates the Deuel decision by some seven years. This court in O'Farrell cautioned that "obvious to try" is an incantation whose meaning is often misunderstood:
It is true that this court and its predecessors have repeatedly emphasized that "obvious to try" is not the standard under § 103. However, the meaning of this maxim is sometimes lost. Any invention that would in fact have been obvious under § 103 would also have been, in a sense, obvious to try. The question is: when is an invention that was obvious to try nevertheless nonobvious?
In re O'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988). To differentiate between proper and improper applications of "obvious to try," this court outlined two classes of situations where "obvious to try" is erroneously equated with obviousness under § 103. In the first class of cases,
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.
Id. In such circumstances, where a defendant merely throws metaphorical darts at a board filled with combinatorial prior art possibilities, courts should not succumb to hindsight claims of obviousness. The inverse of this proposition is succinctly encapsulated by the Supreme Court's statement in KSR that where a skilled artisan merely pursues "known options" from a "finite number of identified, predictable solutions," obviousness under § 103 arises. 550 U.S. at 421.
The second class of O'Farrell's impermissible "obvious to try" situations occurs 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.
853 F.2d at 903. Again, KSR affirmed the logical inverse of this statement by stating that § 103 bars patentability unless "the improvement is more than the predictable use of prior art elements according to their established functions." 550 U.S. at 417.
This court in O'Farrell found the patentee's claims obvious because the Board's rejection of the patentee's claims had not presented either of the two common "obvious to try" pitfalls. 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.
In this case, prior art pointed the way.
The record shows that the prior art teaches a protein of interest, a motivation to isolate the gene coding for that protein, and illustrative instructions to use a monoclonal antibody specific to the protein for cloning this gene. Therefore, the claimed invention is "the product not of innovation but of ordinary skill and common sense." KSR, 550 U.S. at 421. Or stated in the familiar terms of this court's longstanding case law, the record shows that a skilled artisan would have had a resoundingly "reasonable expectation of success" in deriving the claimed invention in light of the teachings of the prior art. See O'Farrell, 853 F.2d at 904.
Science looks like magic to those who don't understand it. In previous decisions, the CAFC had foolishly alluded to whether an art area was "predictable." For example, in Line Rothman, the appeals court considered clothing design predictable, the bias being that they could easily understand it. But all technologies have a degree of predictability to one skilled in the art. Here, the CAFC sheds that skin. For patentability, a court's guessing game of predictability is replaced by proximity analysis: how close was the prior art? A "minor advance in the art" doesn't cross the threshold of patentability, as it would be obvious to try.
This court also declines to cabin KSR to the "predictable arts" (as opposed to the "unpredictable art" of biotechnology). In fact, this record shows that one of skill in this advanced art would find these claimed "results" profoundly "predictable." The record shows the well-known and reliable nature of the cloning and sequencing techniques in the prior art, not to mention the readily knowable and obtainable structure of an identified protein. Therefore this court cannot deem irrelevant the ease and predictability of cloning the gene that codes for that protein. This court cannot, in the face of KSR, cling to formalistic rules for obviousness, customize its legal tests for specific scientific fields in ways that deem entire classes of prior art teachings irrelevant, or discount the significant abilities of artisans of ordinary skill in an advanced area of art. See In re Durden, 763 F.2d 1406, 1411 (Fed. Cir. 1985) ("Our function is to apply, in each case, § 103 as written to the facts of disputed issues, not to generalize or make rules for other cases which are unforeseeable."). As this court's predecessor stated in In re Papesch, "[t]he problem of 'obviousness' under section 103 in determining the patentability of new and useful chemical compounds . . . is not really a problem in chemistry or pharmacology or in any other related field of science such as biology, biochemistry, pharmacodynamics, ecology, or others yet to be conceived. It is a problem of patent law." 315 F.2d 381, 386 (CCPA 1963).
The record in this case shows that Valiante did not explicitly supply an amino acid sequence for NAIL or a polynucleotide sequence for the NAIL gene. In that sense, Kubin and Goodwin's disclosure represents some minor advance in the art. But "[g]ranting patent protection to advances that would occur in the ordinary course without real innovation retards progress." KSR, 550 U.S. at 419. "Were it otherwise patents might stifle, rather than promote, the progress of useful arts." Id. at 427. In light of the concrete, specific teachings of Sambrook and Valiante, artisans in this field, as found by the Board in its expertise, had every motivation to seek and every reasonable expectation of success in achieving the sequence of the claimed invention. In that sense, the claimed invention was reasonably expected in light of the prior art and "obvious to try." See Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008) ("KSR posits a situation with a finite, and in the context of the art, small or easily traversed, number of options that would convince an ordinarily skilled artisan of obviousness."). These references, which together teach a protein identical to NAIL, a commercially available monoclonal antibody specific for NAIL, and explicit instructions for obtaining the DNA sequence for NAIL, are not analogous to prior art that gives "no direction as to which of many possible choices is likely to be successful" or "only general guidance as to the particular form of the claimed invention or how to achieve it." O'Farrell, 853 F.2d at 903. As the Board found, the prior art here provides a "reasonable expectation of success" for obtaining a polynucleotide within the scope of claim 73, Board Decision at 6, which, "[f]or obviousness under § 103 [is] all that is required." O'Farrell, 853 F.2d at 903. Thus, this court affirms the Board's conclusion as to obviousness.
A well-written and reasoned decision by Judge Rader.
Posted by Patent Hawk at April 3, 2009 10:41 PM | Prior Art
With due respect, I disagree. In the Kubin case, even Judge Rader is now running scared from SCOTUS. His treatment of the continuing validity of Deuel is puzzling as SCOTUS said in KSR (as was quoted in the opinion) that "the fact a combination was obvious to try might show that it was obvious under [section] 103." SCOTUS didn't say "would show it was obvious" but you would never believe that after this Kubin decision. If ever there was a case for an en banc hearing, this is one as this panel has, in essence, negated the previously Deuel precedent. I can just see Judge Newman going ballistic over this one (she's the only judge on the Federal Circuit not running scared from SCOTUS).
In addition, Rader makes the astounding (and as Kevin Noonan noted regarding what the applicant’s attorney said at oral argument) factually incorrect statement that Example 12 of the primary Valiante reference teaches isolating the claimed NAIL cDNA (see page 8 of the opinion); as pointed out at oral argument this Example only produced the p38 protein, not the cDNa, and that, as was also stated at oral argument, “you need a staring cell library that will have a sufficient amount of that particular gene that will produce that particular protein.” To put it mildly, Rader’s opinion in Kubin is based on a “factual inaccuracy” which the Board did not have “substantial evidence” to support, despite what Rader’s opinion says.
Posted by: EG at April 4, 2009 7:24 AM
Thanks for your comment. Alas, I don’t see that we disagree. I agree with you. The CAFC is running scared of SCOTUS. And case law with regard to obviousness is obscene.
My draft version of this entry did not have the compliment to Judge Rader. But the decision was well written, in that one could make sense of it, and it provided a useful guideline. Predictability is a bizarre thing to try to judge, whereas gauging the gaps between the prior art record and a claimed invention does, at least, in of itself, have some internal logic.
But the viewpoint, and compliment, is limited to Rader operating within a ridiculous regime.
I don’t agree at all with the logic of obviousness under KSR, and have said so repeatedly. I think the statement “[g]ranting patent protection to advances that would occur in the ordinary course without real innovation retards progress” is itself retarded. If there weren’t patents, there would be an “ordinary course” of innovation, as there would be scant reward for innovation. Any worthwhile advance would be copied. “[R]eal innovation” begs for a sturdy definition.
There’s plenty of prior art. I don’t think the courts ought to be in the guessing game of judging gaps. If one skilled in the art couldn’t put it together from what had been done before, it’s a patentable invention.
One not unreasonable point of KSR is that combinations from different art areas should escape obviousness. But there is some real creativity of doing so. And so it may make sense, rather than just declaring such combination obvious, to look at the utility of the claimed invention as a factor in its patentability. In other words, a combination unconsidered that bears sweet fruit ought to be patentable. This whole Obzilla Superman omnificent genius as everyman, full of creativity, able to leap between tall buildings where no technical teaching existed before, is hogwash.
I can’t speak to factual inaccuracy in this case, but my sense is that the curmudgeonly spirit of the PTO would deny a patent grant if the truth could be twisted (just like cops in court, who will lie to convict), and that the CAFC would let it pass.
This is one area of the law where the courts are hopelessly in the weeds. And there is no prospect of Congress dealing with it, as they are just running a shell game as a hustle for bribes. That’s democracy for you.
Posted by: Patent Hawk at April 4, 2009 10:09 AM
"A fairly common mistake, however odd, is a disconnect between what the applicant thought he claimed and what he actually claimed."
Yes. And these disconnects do more than lose individual cases. They cloud the issues that need to be resolved and keep case law from establishing clear precedents that the rest of us can rely upon.
I have read that the civil rights movement of 50 years ago tried very hard to choose test cases that clearly set forth a single issue to be adjudicated. They wanted to avoid cases with lurking side issues or other defects that might distract the courts or give them a way to escape the primary issue by ruling on technicalities.
I believe we need to do the same. Our legal system depends heavily on case law, and case law can only be as clear as the test cases that are presented to the courts for adjudication.
With respect to the thorny issue of obviousness, PH says above:
“[R]eal innovation” begs for a sturdy definition.
A "sturdy definition" is certainly not going to come from Congress. We need to encourage the courts to create it for us by bringing forward a series of test cases that clearly and concisely set out the concepts that need clarification. That process must begin with well-framed patent claims -- which, as PH repeatedly points out in this blog, are rare animals.
Or, to put it more succinctly: If we (inventors, prosecutors and patent owners) present the courts with muddled questions, can we complain when we get muddled answers?
Posted by: Carl Strathmeyer at April 4, 2009 5:40 PM
Thank you for raising those horrid words, "substantial evidence".
I scoured through the CAFC Kubin decision looking for where the Applicant placed his "evidence" on the record and found none. Unfortunately I was not able to find the BPAI's Kubin decision on the PTO's Freedom of Info page. So I don't know if Kubin there placed any evidence on record (i.e. a Rule 132 declaration).
The point is that; under Gartside, the CAFC has no choice but to affirm. Once an Applicant fails to place his "evidence" into the record, the scales of [substantial] evidentiary support tip totally in favor of the PTO and they win. The game was over even before it began. Appealing to the CAFC was a waste of time.
Posted by: step back at April 5, 2009 5:52 AM
I know you're not a lawyer and that you mean well, but this is a case where you simply don't know the rules of the hyper-legal game being played, the "substantial evidence rule" game.
Let me try to explain in lay person's terms. Do you remember those Perry Mason TV shows where Raymond Burr (was that the actor's name?) always got someone to break down in the witness stand and confess that they had given false testimony? ("Yes, yes, it was me who killed Dr. Kubin and not your client. I framed your client. Once again you have "proven" what a brilliant trial lawyer you are Mr. Mason.") Well, imagine that Perry Mason never approached the witness stand. Imagine that he never cross examined a hostile witness or brought forth his own witnesses. Imagine that after the DA closed his case in chief that Perry Mason simply said, "The defense rests --or more truthfully your Honor, I've been asleep through the whole contest". What would your expectation be of the outcome? Do you think some last angry juror will save Mr. Mason's client? Or do you think that when they get to the jury room, all the jurors will say, Hey the defense never put up a single witness; our hands are tied.
Well it's the latter case for the CAFC in so far as In re Kubin is concerned. Their hands are tied. Search through the Kubin decision and see how many times the word "evidence" is raised. They had no choice. The substantial evidence rule dictated the outcome.
Posted by: step back at April 5, 2009 6:17 AM
I don't see it as running scared as much as trying to set up enough of a pointed dischord and areas of unsellted or contradictory precedent that SCOTUS can come in and "straighten things out" if they feel, as they seem to have indicated in the last few decisions, that somehow the CAFC is putting out gobbledygook. I see it as more of a challenge - a kind of teeing it up - along the lines of "hey we were commissioned more than 20 years ago to create some consistency in patent law, which we think we've done a damned fine job of by the way. You guys say we are wrong, well why don't you see if you can do a better job."
Posted by: Just sayin' at April 5, 2009 4:49 PM
"and areas of unsellted" -> in areas of unsettled
I promise I am not blogging while drinking.
Posted by: Just sayin' at April 5, 2009 4:51 PM
Responding to step back:
No disagreement from me. CAFC could take no other action given what was before them. Perhaps I have not been clear enough with my point... let me try once more.
The patent landscape is clearly changing. We wish the steps along the way were more logical and unambiguous. We complain about decisions, whether because they were poorly reasoned, unclear, or contradictory to decisions in other jurisdictions (or even contradictory to previous decisions from the same jurisdiction, for that matter). Whatever.
I suggest we stop whining and do something more productive. Cases such as in re Kubin don't resolve anything -- precisely for the reasons you mention.
We need cases that generate clear decisions on the merits, and that in turn create useful precedent... not cases like in re Kubin where the Applicant loses because he fails to present enough evidence to support his position.
Or, putting it another way, cases like in re Kubin don't help the US patent system define "obviousness". Better test cases might. Eventually, these will come along. My point is that, like the civil rights campaign, we might be able to accelerate things a bit by presenting carefully selected test cases.
The question, I suppose, is what organization would coordinate such an effort. Maybe we need a NAAPS? (National Association for the Advancement of Patent Sanity)
Posted by: Carl Strathmeyer at April 5, 2009 5:21 PM
"...that bears sweet fruit..."
When I am done weeping with joy, I promise to use this phrase in patent law, to bear the sweet fruit of understanding, every chance I get.
I really mean that.
Posted by: Just sayin' at April 5, 2009 5:45 PM
Thank you for raising those horrid words, "substantial evidence".
I raised those "horrid words" because the PTO's decision (like the Federal Circuit's opinion) is deficient in this the critical commodity, especially in reaching conclusions that are factually incorrect and unsupported by the art relied upon. Also, "substantial evidence" is the test applied to the PTO fact finding, not the applicant (althought as you correctly point out, the applicant has at least some control over what "evidence" gets in); a failure to get the important facts straight is one grounds for showing there's no "substantial evidence" (like the "clear erroneous" standard). If you don't believe me that there's a huge issue with whether there's "substantial evidence," or at least a correct understanding of the factual evidence, to support the Kubin opinion, go check Kevin Noonan's excellent commentary on Kubin in Patent Docs. The astonishing ignorance of important biotech-related facts by this Federal Circuit panel in this case is very disquieting.
Posted by: EG at April 6, 2009 4:19 AM
Because I'm not a bio-tech guy, I'm unfortunately blind to the leaps of scientific logic that the PTO Board and the CAFC may make when assessing whether the species molecule of Kubin is "obvious" to an actually skilled artisan.
I do my ripping out of scalp hair when reading CAFC pontifications about software inventions, about "fundamental principles", and about "tangible" inventions as the CFAC judges are want to do in Bilski, Nuijten and the like.
However, in all these cases, the fundamental questions are: what is the relevant art and how did ordinary artisans in that art think at the time just prior to invention? There is no reason why these questions cannot be answered by expert testimony placed into the record by the Applicants (no reasons except the prohibitive costs of course). As long as Applicants do not submit such evidence, the PTO is free to make up whatever story it wants about the ordinary artisan and what was "obvious" to him/her. The CAFC has to accept those made up stories due to the substantial evidence rule. Simple as that.
Posted by: step back at April 6, 2009 6:22 PM
"I do my ripping out of scalp hair when reading CAFC pontifications about software inventions, about "fundamental principles", and about "tangible" inventions as the CFAC judges are want to do in Bilski, Nuijten and the like."
I'm a chemistry major, but I know enough about the software area to understand your angst over Bilski and Nuitjen. In Bilski, the Federal Circuit has created nonsensical "machine or transformation" test that is creating chaos in the PTO (the Board decisions applying, or more appropriately misapplying the Bilski test are something to behold in terms of lack of logic), now at the district court level (the Cybersource v Retail Decisions case in teh N.D. Cal. is my poster child for why the Bilski test is fundamentally flawed), and now in the medical diagnostic area. The In re Nuitjen decision can be factually supported only if the photoelectric effect Einstein got his Nobel Prize for is scientifically wrong (and I'm with Judge Linn's dissent that the majority got this case very factually and legally wrong). And the analogy by the SCOTUS majority in Microstoft v. AT&T of software to an "architectural blueprint" is laughable in the extreme. Perhaps we should all now believe that the "moon is made of green cheese."
Posted by: EG at April 7, 2009 5:30 AM