Kubin and Permissibility of the 'Obvious to Try' Standard

Urged by the Supreme Court's opinion in KSR, the Federal Circuit has addressed its precedent regarding the obvious-to-try standard, positively stating a standard implied in its previous holdings.

In In re O'Farrell, 853 F.2d 894 (Fed. Cir. 1988), the Federal Circuit, though noting that it and its predecessors have repeatedly emphasized that “obvious to try” is not the standard under ' 103, at the same time implicitly indicated that such a standard could be appropriate in certain situations. O'Farrell at 903-904. To confuse the issue further, the court later, in In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995), reaffirmed the O'Farrell court that “obvious to try” was long held not to constitute obviousness, and thus, found the claims in the subject reference not to be obvious. Deuel at 1559. Though, as indicated in Deuel, obvious-to-try was long held not to be the standard under ' 103, the U.S. Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) specifically seized on Deuel to discredit any holding that “obvious to try” was a dead standard. Accordingly, in a post-KSR opinion, the court in In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) waded through the O'Farrell and Deuel opinions and, with deference to the opinion of the Supreme Court in KSR, affirmatively stated the implicit indication from O'Farrell that obvious-to-try is a proper standard in certain situations.

Specifically, the court in Kubin held that there are two situations in which obvious-to-try is an appropriate argument under ' 103, namely, 1) where a skilled artisan merely pursues “known options” from a “finite number of identified, predictable solutions,” and 2) where the improvement is no more than the predictable use of prior art elements according to their established functions. Kubin, 561 F.3d at 1359, quoting KSR, 550 U.S. at 417 and 421. Conversely, the court in Kubin reiterated that obvious-to-try is an improper argument 1) where what would have been allegedly obvious-to-try was to vary all parameters or try each of numerous possible choices until arriving at a successful result, where the prior art gave either no indication of critical parameters or any other direction as to which of many possible choices was likely to be successful, and 2) where what was allegedly obvious-to-try was to explore new technology or a general approach that seemed promising, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it. Id.

The Kubin Case

Applicants Kubin et al. filed U.S. Serial No. 09/667,859 (“the '859 application”) containing claims to a DNA sequence that encodes a particular polypeptide that binds to a specific region of a protein. During prosecution, the claims of the '859 application were rejected as obvious under ' 103 both during prosecution and on appeal to the Board of Patent Appeals over a reference that taught the polypeptide in view of another reference that describes methods for molecular cloning. Because the prior art did not teach the actual DNA sequence of the claims, Kubin argued the claims could not be considered obvious.

Based on the above factual findings, the Board invoked the Supreme Court's decision in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), and concluded that the applicant's claim was “the product not of innovation but of ordinary skill and common sense, leading us to conclude claimed DNA is not patentable as it would have been obvious to isolate it.” Board Decision at 9 (citing KSR, 550 U.S. at 421). The applicants subsequently appealed to the Federal Circuit.

The Federal Circuit determined that the Board had substantial evidence to conclude that appellants used conventional techniques, as taught in the prior art, to isolate the claimed DNA sequence. Board Decision at 8. However, appellants claimed a gene sequence and not a method. Thus, the court determined that the obviousness inquiry required an evaluation of whether the claimed sequence was obvious in light of the prior art. Id. In this regard, the court arrived at a holding of obviousness, in part, based on the fact that obtaining the claimed DNA would have been obvious-to-try in light of prior art techniques for obtaining DNA sequences and teachings of the exact protein to which the claimed DNA sequence would bind.

In arriving at its holding, the court considered its prior precedent regarding classical biotechnical inventions, specifically, In re O'Farrel, 853 F.2d 894 (Fed. Cir. 1988).

In re O'Farrell

In O'Farrell, three years prior to applying for a patent, two inventors published their work concerning a method for producing a predetermined protein in a stable form in a host species of bacteria. Later, the inventors claimed a similar method in which the major change was the addition of a “heterologous gene” rather than merely a “gene” as published in their prior art. The inventors argued that, at the time the prior art article was published, there was significant unpredictability in the field as to whether a heterologous gene would work in the method. Unfortunately for the inventors, their article also invited the possibility of adding a heterologous gene, which the applicants argued only made the pursuit of a heterologous gene obvious-to-try, and therefore, an improper basis for a rejection based on obviousness.

Noting that the standard of “obvious to try” was repeatedly considered improper, the court in O'Farrell also noted that any invention that would in fact have been obvious under ' 103 would also have been obvious-to-try. O'Farrell, 853 F.2d at 903. Thus, the court indicated that the proper question is, “when is an invention that was obvious to try nevertheless nonobvious?” Id. Answering the question, the O'Farrell court set forth two instances where obvious-to-try was not the standard under ' 103; the first being when the inventor is faced with “numerous possible choices ' 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,” and the second, when “the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.” Id. at 903. After pointing out when obvious-to-try was not the appropriate standard, the O'Farrell court found that neither improper situation was present in the case before it. Although the court implied that the obvious-to-try standard could be proper in the case, it ultimately held that the subject matter under review was obvious under a traditional obviousness standard. Still, the implication from In re O'Farrell was that obvious-to-try is an acceptable argument in certain cases where one could reasonably expect his attempts to be successful.

Conclusion

In KSR, the Supreme Court directed the obviousness standard away from a formalistic approach. In particular regard to the obvious-to-try standard, the Supreme Court seized on the decision of In re Deuel as a case standing for the rejection of the obvious-to-try standard, and unambiguously discredited such holdings. Thus, the Federal Circuit was compelled to bring clarity to the obvious-to-try standard, which the court did in In re Kubin.

While Kubin seemingly resuscitated the obvious-to-try standard, practitioners must still use caution before hanging a case of invalidity solely thereon. In particular, what is required to prove a proper obvious-to-try assertion will turn on the facts of each case. In light of the court's long-held belief that obvious-to-try should not be an appropriate standard, the specific facts that will be necessary to establish that a claimed invention is the result of the mere pursuit of “known options” from a “finite number of identified, predictable solutions,” or no more than the predictable use of prior art elements according to their established functions remains to be seen.

Christopher P. Demas is an associate at Pearne & Gordon LLP with a practice focusing on prosecuting mechanical and chemical patent applications and can be contact at [email protected].

Urged by the Supreme Court's opinion in KSR, the Federal Circuit has addressed its precedent regarding the obvious-to-try standard, positively stating a standard implied in its previous holdings.

In In re O'Farrell, 853 F.2d 894 (Fed. Cir. 1988), the Federal Circuit, though noting that it and its predecessors have repeatedly emphasized that “obvious to try” is not the standard under ' 103, at the same time implicitly indicated that such a standard could be appropriate in certain situations. O'Farrell at 903-904. To confuse the issue further, the court later, in In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995), reaffirmed the O'Farrell court that “obvious to try” was long held not to constitute obviousness, and thus, found the claims in the subject reference not to be obvious. Deuel at 1559. Though, as indicated in Deuel , obvious-to-try was long held not to be the standard under ' 103, the U.S. Supreme Court in KSR International Co. v. Teleflex Inc. , 550 U.S. 398, 421 (2007) specifically seized on Deuel to discredit any holding that “obvious to try” was a dead standard. Accordingly, in a post-KSR opinion, the court in In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) waded through the O'Farrell and Deuel opinions and, with deference to the opinion of the Supreme Court in KSR, affirmatively stated the implicit indication from O'Farrell that obvious-to-try is a proper standard in certain situations.

Specifically, the court in Kubin held that there are two situations in which obvious-to-try is an appropriate argument under ' 103, namely, 1) where a skilled artisan merely pursues “known options” from a “finite number of identified, predictable solutions,” and 2) where the improvement is no more than the predictable use of prior art elements according to their established functions. Kubin, 561 F.3d at 1359, quoting KSR, 550 U.S. at 417 and 421. Conversely, the court in Kubin reiterated that obvious-to-try is an improper argument 1) where what would have been allegedly obvious-to-try was to vary all parameters or try each of numerous possible choices until arriving at a successful result, where the prior art gave either no indication of critical parameters or any other direction as to which of many possible choices was likely to be successful, and 2) where what was allegedly obvious-to-try was to explore new technology or a general approach that seemed promising, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it. Id.

The Kubin Case

Applicants Kubin et al. filed U.S. Serial No. 09/667,859 (“the '859 application”) containing claims to a DNA sequence that encodes a particular polypeptide that binds to a specific region of a protein. During prosecution, the claims of the '859 application were rejected as obvious under ' 103 both during prosecution and on appeal to the Board of Patent Appeals over a reference that taught the polypeptide in view of another reference that describes methods for molecular cloning. Because the prior art did not teach the actual DNA sequence of the claims, Kubin argued the claims could not be considered obvious.

Based on the above factual findings, the Board invoked the Supreme Court's decision in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), and concluded that the applicant's claim was “the product not of innovation but of ordinary skill and common sense, leading us to conclude claimed DNA is not patentable as it would have been obvious to isolate it.” Board Decision at 9 (citing KSR , 550 U.S. at 421). The applicants subsequently appealed to the Federal Circuit.

The Federal Circuit determined that the Board had substantial evidence to conclude that appellants used conventional techniques, as taught in the prior art, to isolate the claimed DNA sequence. Board Decision at 8. However, appellants claimed a gene sequence and not a method. Thus, the court determined that the obviousness inquiry required an evaluation of whether the claimed sequence was obvious in light of the prior art. Id. In this regard, the court arrived at a holding of obviousness, in part, based on the fact that obtaining the claimed DNA would have been obvious-to-try in light of prior art techniques for obtaining DNA sequences and teachings of the exact protein to which the claimed DNA sequence would bind.

In arriving at its holding, the court considered its prior precedent regarding classical biotechnical inventions, specifically, In re O'Farrel, 853 F.2d 894 (Fed. Cir. 1988).

In re O'Farrell

In O'Farrell, three years prior to applying for a patent, two inventors published their work concerning a method for producing a predetermined protein in a stable form in a host species of bacteria. Later, the inventors claimed a similar method in which the major change was the addition of a “heterologous gene” rather than merely a “gene” as published in their prior art. The inventors argued that, at the time the prior art article was published, there was significant unpredictability in the field as to whether a heterologous gene would work in the method. Unfortunately for the inventors, their article also invited the possibility of adding a heterologous gene, which the applicants argued only made the pursuit of a heterologous gene obvious-to-try, and therefore, an improper basis for a rejection based on obviousness.

Noting that the standard of “obvious to try” was repeatedly considered improper, the court in O'Farrell also noted that any invention that would in fact have been obvious under ' 103 would also have been obvious-to-try. O'Farrell, 853 F.2d at 903. Thus, the court indicated that the proper question is, “when is an invention that was obvious to try nevertheless nonobvious?” Id. Answering the question, the O'Farrell court set forth two instances where obvious-to-try was not the standard under ' 103; the first being when the inventor is faced with “numerous possible choices ' 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,” and the second, when “the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.” Id. at 903. After pointing out when obvious-to-try was not the appropriate standard, the O'Farrell court found that neither improper situation was present in the case before it. Although the court implied that the obvious-to-try standard could be proper in the case, it ultimately held that the subject matter under review was obvious under a traditional obviousness standard. Still, the implication from In re O'Farrell was that obvious-to-try is an acceptable argument in certain cases where one could reasonably expect his attempts to be successful.

Conclusion

In KSR, the Supreme Court directed the obviousness standard away from a formalistic approach. In particular regard to the obvious-to-try standard, the Supreme Court seized on the decision of In re Deuel as a case standing for the rejection of the obvious-to-try standard, and unambiguously discredited such holdings. Thus, the Federal Circuit was compelled to bring clarity to the obvious-to-try standard, which the court did in In re Kubin.

While Kubin seemingly resuscitated the obvious-to-try standard, practitioners must still use caution before hanging a case of invalidity solely thereon. In particular, what is required to prove a proper obvious-to-try assertion will turn on the facts of each case. In light of the court's long-held belief that obvious-to-try should not be an appropriate standard, the specific facts that will be necessary to establish that a claimed invention is the result of the mere pursuit of “known options” from a “finite number of identified, predictable solutions,” or no more than the predictable use of prior art elements according to their established functions remains to be seen.

Christopher P. Demas is an associate at Pearne & Gordon LLP with a practice focusing on prosecuting mechanical and chemical patent applications and can be contact at [email protected].