January, 2018｜News Letter

1. Does Prosecution of Appeal Trial Against Decision of Final Rejection Violate Procedures?

Idera Pharmaceuticals, Inc. v. Commissioner of JPO, Case No. 2018 (Gyo-Ke) 10218 (Decision rendered on January 30, 2018)

The Applicant, Idera, filed a patent application relating to Immune Regulatory Oligonucleotide (IRO) Compounds to Modulate TOLL-Like Receptor Based Immune Response in 2006. However, since Examiner’s decision of rejection was issued in 2014, the applicant filed an appeal in the same year. The application, however, was finally rejected in 2016 by the Board of Appeals of the JPO on the grounds of violation of Enablement Requirement and Support Requirement. Against the JPO's decision, Idera filed a cancellation action with the IPHC in 2016.

The main issue among three issues (violation of procedures, violation of the enablement requirement and violation of the support requirement) in this case is violation of procedures, i.e. whether procedures were violated during the prosecution of an appeal trial against an Examiner's decision of refusal.

In the amendment filed on March 17, 2016 as a response to an Office Action of September 16, 2015 issued at the appeal stage, Claims 1 to 18 including Claims 1, 14 and 15 are claimed. Claims 1, 14 and 15 are as follows.

1. An immune regulatory oligonucleotide (IRO) compound having the structure
5'-N_m - N₃N₂N₁CGN¹N²N³ - N^m -3':
wherein: … (snip) ….

14. A composition comprising a compound according to any one of Claims 1 to 7 for therapeutically treating a vertebrate having a disease mediated by a TLR, wherein the TLR is selected from TLR7, TLR8 and/or TLR9.

15. The composition according to Claim 14, wherein the disease is cancer, an autoimmune disorder, airway inflammation, inflammatory disorders, infectious disease, skin disorders, allergy, asthma or a disease caused by a pathogen.

After filing the amendment as above, the JPO’s decision was issued without a further Office Action being issued.

In the JPO’s decision, the present application was rejected in view of failing to meet the Enablement Requirement and Support Requirement. Specifically, the Board concluded that those skilled in the art could not understand whether all IRO compounds in the present application have antagonistic activity to TLR7, TLR8 and/or TLR9 referred to in Claim 14 and whether those compounds could treat the disease mediated by TLR7, TLR8 and/or TLR9, which is cancer, an autoimmune disorder, airway inflammation, inflammatory disorders, infectious disease, skin disorders, allergy, asthma or a disease caused by a pathogen TLR7, TLR8 and/or TLR9 related to Claim 15.

However, according to the Office Action of September 16, 2015, the Board states that “[i]n the present specification, the various IRO compounds’ antagonistic activities are confirmed with respect to 'TLR7', 'TLR8' and 'TLR9' only, as TLR. It is unclear whether those IRO compounds could attain antagonistic activity to other TLRs. In the same manner, those skilled in the art could not appreciate that other diseases mediated by TLRs than those mediated by 'TLR7', 'TLR8' and 'TLR9' could also be treated by IRO compounds of the present application.”

Consequently, according to the above statements in the Office Action, it is natural that the applicant considers that objections in view of Enablement Requirement and Support Requirement could be overcome by limiting TLR to 'TLR7, TLR8 and/or TLR9'. Actually, the applicant amended the claims as above Claims 14 and 15. That is, the applicant limited TLR to 'TLR7, TLR8 and/or TLR9” by deleting the reference to 'TLR1 to TLR6'.

Nevertheless, in the JPO’s decision, the present application was finally rejected in view of failing to meet the Enablement Requirement and Support Requirement even though TLR is limited to 'TLR7, TLR8 and/or TLR9'.

As mentioned above, against the JPO's decision, Idera filed a cancellation action with the IPHC in 2016.

Regarding the above JPO's decision, the IPHC concludes that if the Board rejects amended claims in which 'TLR' is limited to 'TLR7, TLR8 and/or TLR9', the Board should have issued a further Office Action which notifies the applicant that even if 'TLR' is limited to 'TLR7, TLR8 and/or TLR9', Enablement Requirement and Support Requirement are not yet satisfied.

Specifically, as to the invention related to 'TLR9', the IPHC concludes that patentability requirements are satisfied. However, as to the invention of 'TLR7' and 'TLR8', the IPHC also considers that patentability requirements are not satisfied.

Therefore, the IPHC concludes that the JPO should have issued an Office Action which notifies the applicant that the invention related to 'TLR7' and 'TLR8' satisfies neither Enablement Requirement nor Support Requirement. The IPHC states that the JPO's decision without issuing a further Office Action means to deprive the applicant of an opportunity to amend the claims so that the invention related to ' TLR7' and 'TLR8' can be deleted and the invention related to “TLR9” only is claimed in the application.

Conclusively, the IPHC upheld the Idera’s appeal and canceled the JPO’s decision.

An appeal to the Supreme Court was NOT filed against this decision, and thus the decision is final and binding.

K&P’s Comments When receiving a decision of rejection from the JPO, the reasons of the rejection in the decision should be reviewed carefully as to whether said reasons were already noticed in the Office Action(s) and an opportunity for making an amendment was given before the issuance of the decision. Otherwise, a cancellation action with the IPHC for reason of violation of procedures should be considered.

(by Kayo SHIINA, Patent Attorney)

In January 2018, the IPHC handed down 12 decisions including the above case on patent and utility model, and overturned the previous decisions in 2 cases.

In January 2018, the IPHC handed down 4 decisions on trademark, and maintained all of the previous decisions.

In January 2018, the IPHC handed down no decision on industrial design.