Patent Law

Pointer

By Gary Odom and Jordan Kuhn

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.

Affirmed.

A well-written and reasoned decision by Judge Rader.

Full post as published by The Patent Prospector on April 04, 2009 (boomark / email).