JPO’s Reliance on Experimental Results in Patent Applications -From the Aspect of Requirements for Description of Claims and Specification- JPAA International Activities Center Nobuo SEKINE January 28, 2014 AIPLA Midwinter Institute IP Practice in Japan Committee Pre-Meeting

(AIPLA MWI) Background - Regarding the requirements for description of claims and specification, JPO relies on experimental results in patent applications in a different way from USPTO. - Therefore, US applicants sometimes encounter difficult situations regarding the JPO requirements.  How JPO relies on experimental results described in patent applications, and how US applicants can avoid a difficult situation?

(AIPLA MWI) JP Patent Act Under JP patent practice, the requirements for description of claims and specification include:  Support Requirement (Art. 36, Para. 6, Items 1) the invention for which a patent is sought is stated in the specification (corresponding to 35USC112 Para. 1 (Written Description Requirement));  Definiteness Requirement (Art. 36, Para. 6, Items 2) the invention for which a patent is sought is definite (corresponding to 35USC112 Para. 2);  Enablement Requirement (Art. 36, Para. 4, Item 1) the statement of specification shall be clear and sufficient as to enable any skilled person in the art to work the invention (corresponding to 35USC112 Para. 1)

(AIPLA MWI) JP Guideline Support Requirement is satisfied, only if a skilled person can recognize, from the specification and/or technical common knowledge, that the entire range of a claimed invention can actually solve “a problem to be solved,” i.e. exert the effect of the invention in a similar way to experimental results shown in the specification. (under US practice?) (Exam. Guide., Part I, Chapter 1, “Basic Rules for Exam. on the Requirement of Art. 36(6)(i)”)

(AIPLA MWI) JP Guideline (Cont.) – Case 1  Ex. Results + Description (and/or technical common knowledge) for generalization (i.e. cause-and- effect logic, mechanism, etc.)?  OK Claim Scope Ex. Description, etc. for generalization

(AIPLA MWI) JP Guideline (Cont.) – Description for Generalization? Ex. Result Static charge of a polymer material was prevented by adding carbon black to the polymer material. Description for generalization (Mechanism, etc.) Static charge of a polymer material is prevented by electro-conductivity of carbon black, and therefore other electro-conductive powders, such as carbon fiber and metal powder can be used in a similar way to carbon black. Supported Claim “An antistatic polymer material containing carbon powder and/or metal powder.”

(AIPLA MWI) JP Guideline (Cont.) – Case 2  Ex. Results + No description, etc. for generalization?  NO (OK under US practice?) Ex. Claim Scope No Description etc. for generalization

(AIPLA MWI) JP Guideline (Cont.) – Case 3  Ex. Results + Insufficient description, etc. for generalization?  NO Ex. Claim Scope Description etc. for generalization

(AIPLA MWI) JP Guideline (Cont.) – Case 4  Ex. Results + Insufficient description, etc. for generalization + Additional Ex. Results (Declaration)?  NO Ex. Claim Scope Add. Ex. Description etc. for generalization

(AIPLA MWI) JP Guideline (Cont.) – Case 5  Cf. Situation where Additional Ex. Results (Declaration) are useful  OK (Add. Ex. Results are useful only for proving/supporting the description, etc. for generalization) Claim Scope Ex. Add. Ex. Description etc. for generalization

(AIPLA MWI) Polarizing Film Case Summary of Case: 2005 (Gyo-Ke) (IP High Court ( Grand Panel )) Representative case for the Support Requirement and Enablement Requirement Judgment: “The purpose of the patent system is to encourage inventions and contribute to the development of industry by granting patents to the inventions on the premise of disclosure of the inventions …. …, it is necessary to describe the invention in the specification so that a person ordinarily skilled in the art can recognize that the problem to be solved by the invention can be solved.”

(AIPLA MWI) Polarizing Film Case (Cont.) “Whether the statement of the scope of claims satisfies the Support Requirement should be determined by considering, …, whether a claimed invention is … within the scope which a skilled person … can recognize, based on the statement of the specification, … and … in light of the technical common knowledge as of the time of filing the application, that the invention can solve the problem to be solved, …. For the Support Requirement of a Description, it is reasonable to understand that the patent applicant (…) or the patentee (…) assumes the burden of proof.” Ex. Claim Scope Case 1 (OK) Case 2 (NO)

(AIPLA MWI) Polarizing Film Case (Cont.) “…, the Support Requirement of a Description is not satisfied by expanding or generalizing the content described in the specification to the scope of a claimed invention by adding the content outside the purport of the statement by submitting experimental data after filing a patent application, (if the specification is not sufficient to satisfy the Support Requirement ). This is because such act goes against the purpose of the patent system.” Ex. Claim Scope Add. Ex. Case 4 (NO)

(AIPLA MWI) Hard Coating Material Case Summary of Case: 2007 (Gyo-Ke) (IP High Court) Case after the Polarizing Film Case Judgment: “…, it may be possible to satisfy the Support Requirement even with a few examples; however, in such a case, the cause-and-effect logic or mechanism which enables the claimed invention to solve the problem or to achieve the aim of the invention, should be described in the specification or clear to a skilled person.” Ex. Claim Scope Case 1 (OK) Case 2 (NO)

(AIPLA MWI) Modulators of Body Weight Case Summary of Case: 2005 (Gyo-Ke) (IP High Court), Case regarding “non-useful embodiment” Judgment: “The results of more than 50 examples described in the specification cannot be deemed to be sufficient to enable persons skilled in the art to recognize utility or clear distinctiveness of the present invention. Additionally, there is the objective fact that some nucleic acid molecules are not useful. ”

(AIPLA MWI) Modulators of Body Weight Case (Cont.) “Gene-related inventions should not be regarded as industrially applicable inventions unless they are proved to be useful. The scope of a claimed invention includes not only useful nucleic acid molecules described in the specification, but also nucleic acid molecules that are not useful. In other words, the scope of claims goes beyond the scope of the invention described in the specification. Therefore, it is clear that the Application does not satisfy the description requirement prescribed in Article 36(6) (i).” Ex. Claim Scope Case 3 (NO)

For Drafting Application - A description for generalization (cause-and-effect logic, mechanism, etc.) in the specification, as well as Ex. Results, are useful in order to satisfy the support requirement (one of the requirements for description of claims and specification). Practice Tips (AIPLA MWI)

For OA Response - Technical common knowledge can be used in place of the description for generalization in the specification. - Add. Ex. Results (declaration) may be useful only for proving/supporting the description in the specification (and/or technical common knowledge) for generalization. Practice Tips (Cont.) (AIPLA MWI)

Disclaimer The views expressed in this presentation are those of the author and do not necessarily reflect the views of JPAA or the author’s firm. This presentation is for general informational purposes only and should not be taken as legal advice (AIPLA MWI)

Nobuo SEKINE SEIWA PATENT AND LAW Toranomon37 Mori Bldg. 10F, Toranomon, Minato-ku, Tokyo , JAPAN THANK YOU (AIPLA MWI)