[Bio IP Information] HARAKENZO WORLD PATENT & TRADEMARK - Leading Patent Law Firm in Japan(Osaka & Tokyo)

1. Introduction
While some experts viewed that the KSR US supreme court judgment rendered by the US supreme court on April 30, 2007 would have effects only on "predictable art", such as fields of mechanics or electronics etc., and few effects on "unpredictable art", such as fields of biology or chemistry etc., the CAFC judgment according to KSR judgment was rendered in connection with the biological inventions. This would become a new standard for non-obviousness, "Obvious to try" in the biological inventions. Let me explain this judgment together with a similar judicial precedent in Japan.

2. In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009)

Applicants (Marek Z. Kubin et al.)filed a patent application " NK cell Activation inducing Ligand (NAIL) DNA and Polypeptides, and Use thereof" on September 20, 2000. NH cells remove tumor or virus-infected cells etc., and play one of the main roles in the immune system that controls immune response via the emission of cytokine. As described in the background of this invention, it is known that human NK cells have a particular surface protein called "p38" or "NAIL", and exerts cytopathy or cytokine emission ability by activating this surface protein. However, its amino-acid sequence or nucleotide sequence of gene coding for such protein was not identified.
In the above application, Kubin et al. presented a possibility of new medicinal application of human p38 (NAIL) protein by demonstrating that cDNA encoding for human p38 (NAIL) protein was cloned, the nucleotide sequence was identified and NAIL protein was linked to CD48 which is a marker cell in the immune system. The invention filed by Kubin et al. encompasses the nucleotide sequence encoding for CD48 connective protein, that is 80% homologous with the amino acid sequence of NAIL protein, and its use.
The examiner of USPTO denied unobviousness of the subject invention over the cited reference disclosing (i) the presence of p38 (NAIL) protein related to signaling and cellular cytotoxicity of NK cell; (ii) monoclonal antibody bound specifically to p38 (NAIL) protein. The examiner stated that although the reference did not disclose the amino acid sequence or nucleotide sequence of p38 (NAIL) protein, it was possible to identify the nucleotide sequence of p38 (NAIL) cDNA and amino acid sequence of p38 (NAIL) protein using the known art. Although the applicant filed an appeal to BPAI, the obviousness rejection was maintained, and thus the applicant filed a petition of objection to CAFC.
CAFC maintained the judgment of BPAI, stating "the applicant merely isolated cDNA in NAIL using the known art. At the time of filing the subject application, the importance of the isolation of cDNA in NAIL had been fully recognized by the person skilled in the art, and thus it is fully motivated to isolate cDNA in NAIL using the known art." As such, CAFC did not apply In re Deuel standard which had been applied in biological invention, and made a judgment that the invention did not have unobviousness, supporting the judgment of USPTO.
Firstly, it should be noted that CAFC followed KSR US supreme court judgment, and thereby denied the CAFC judgment of In re Deuel in which "obvious to try" is inappropriate as a test for obviousness. The outline of CAFC judgment of In re Deuel is that although partial amino acid sequence of protein is publicly known, a number of nucleic acid molecules encoding for such protein are present, and thus even if the general method for the gene cloning is publicly known, it is not obvious to obtain the nucleic acid molecule encoding for such protein. The judgment has had considerable effects on the judgment of unobviousness of biological inventions.
Secondly, referring to KSR US supreme court judgment, CAFC stated that the claim considered to be "obvious to try" was not necessarily and automatically deemed to be obvious based on the article 103, and that unobviousness can be claimed based on In re O’Farrell if:
(1) trial-and-error approach was carried out, e.g. by changing all parameters or attempting a number of choices, until a successful result was obtained, where the prior arts had not suggested or indicated which parameter is important, or which choice is likely to be successful among many choices;
(2) experiments were carried out for exploring a new technology or a general approach that seemed to be a promising field of experimentation, where the prior art only gave only general guidance as to the particular form of the claimed invention or how to achieve it.
In particular, it is considered that the second point in re Kubin is a useful suggestion for claiming unobviousness and can be applied not only to the biological invention but to all technical fields.

3. Judicial Precedent in Japan based on Similar Judgment
Japan also has a judicial precedent in which the similar judgment as in re Kubin was made. Let me explain the outline of such case.
The subject invention relates to immunoreactive polypeptide composition including epitope which exists in the variable domain of envelop polypeptide of HCV (hepatitis C virus), and is applicable to vaccine etc. The court pointed out that the cited reference 1 suggested the possibility of the presence of immunoreactive polypeptide in the hypervariable domain of HCV, and the cited reference 3 suggested epitope and a section inducing neutralizing immune response are present in the variable domains of different viruses. Given these facts, the court upholded the trial decision wherein the inventive step is denied, stating that "in conjunction with the suggestion of the cited reference 1 and the description of the cited reference 3, a person skilled in the art expects the presence of immunoreactive section including epitope in the hypervariable domain of HCV envelope polypeptide as in HIV-1 and is strongly motivated to confirm it. Even if immunoreactiveness within the hypervariable domain of HCV envelope polypeptide is confirmed as a result thereof, this merely means the result as expected by the person skilled in the art is obtained…"
The above judicial precedent is introduced as "the claimed invention related to a certain protein with a newly found function lacks an inventive step, as the protein function must be foreseen, and there could have been strong motivation to confirm the existence of the protein function before the filing date (priority date)" in Major Judicial Precedents of Biological Invention by Appeals Department, JPO. The examination standard of in re Kubin adopts the similar approach. Both in US and in Japan, the inventive step (or unobviousness) is denied if the person skilled in the art has a strong motivation and it is obvious for him/her to attempt the invention with reasonable expectation of success, and significance of the effect is not recognized.

(Cited references)
[1] In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009)
[2] In re Deuel, 51 F.3d 1552, 1558-59, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995)
[3] KSR v. Teleflex, 550 U.S. 398 (2007)
[4] In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988)
[5] Heisei 17 (Gyo-ke) 10073 (Judicinal Date: May 17, 2005)
[6] Case 7 "Immunoreactive Polypeptide Composition of Hepatitis C virus" Major Judicial Precedents of Biological Invention, Japan Patent Office