2014 Procedure for Subject Matter Eligibility 2014 Procedure for Subject Matter Eligibility 2014 Procedure for Subject Matter Eligibility 2014 Procedure for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Analysis of Claims Reciting or Involving Laws of Analysis of Claims Reciting or Involving Laws of Analysis of Claims Reciting or Involving Laws of Nature, Natural Phenomena, and/or Natural Nature, Natural Phenomena, and/or Natural Nature, Natural Phenomena, and/or Natural Nature, Natural Phenomena, and/or Natural Products Products Products Products Prepared for Korean Intellectual Property Office September 17, 2014 Presented by: Sunhee Lee & Mihsun Koh
선언 - 본 면책 면책 면책 면책 선언 선언 선언 본 본 본 문서는 문서는 문서는 정보의 문서는 정보의 정보의 정보의 교환 교환 및 교환 교환 및 및 및 교육을 교육을 교육을 교육을 목적으로 목적으로 목적으로 목적으로 것으로서 , 법률적 하여 작성된 하여 하여 하여 작성된 것으로서 작성된 작성된 것으로서 것으로서 법률적 법률적 자문이나 법률적 자문이나 자문이나 자문이나 제안을 제안을 제안을 제안을 포함하고 포함하고 포함하고 포함하고 않으며 , 법률적인 있지 않으며 있지 있지 있지 않으며 않으며 법률적인 법률적인 자문을 법률적인 자문을 자문을 하기 자문을 하기 위한 하기 하기 위한 위한 위한 목적으로 목적으로 목적으로 목적으로 없습니다 . 사용될 사용될 수 수 없습니다 사용될 사용될 수 수 없습니다 없습니다 KIPO Seminar 2014 KAIPBA Roadshow 2
Background: Mayo v. Prometheus (2012) → (Diagnostic) method claims of “a law of nature ” + “routine, conventional steps” is not patent eligible. Representative Claim of two Prometheus patents: A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising a) administering one of a class of drugs (thiopurines), and b) determining the level of a specified metabolite wherein “a level below a given threshold indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level above the threshold indicates a need to decrease the amount of said drug subsequently administered to said subject.” KIPO Seminar 2014 KAIPBA Roadshow 3
Mayo v. Prometheus (cont'd) 9 -0 Supreme Court Decision: Application of a law of nature is patentable, but • “simply appending conventional steps , …to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable.” • When “putting” the law of nature step “to the side, there was no ‘inventive concept ’ in the claimed application” of the law of nature and “the other steps in the process did not limit the claim to a particular application .” • something more is required. • to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words “apply it. ” KIPO Seminar 2014 KAIPBA Roadshow 4
Background: AMP v. Myriad (2013) � Case seeking to invalidate patents covering � wild-type and mutated sequences of BRCA1 and BRCA2 genes, and � Correlations between genetic variants and the predisposition to breast and ovarian cancer � 9-0 decision, Supreme Court held the naturally occurring DNA sequences are "products of nature" that cannot be patented � However, the Court reached the opposite conclusion with respect to cDNA, finding that cDNA is not a "product of nature" KIPO Seminar 2014 KAIPBA Roadshow 5
AMP v. Myriad (cont'd) � Court acknowledged Myriad's contributions but found that "Myriad did not create anything" � "Separating that gene from its surrounding genetic material is not an act of invention" � Fundamental essence of DNA is its information content, Myriad's claims were not directed at chemical composition or chemical changes but rather they were directed at the genetic information encoded in the genes � On the other hand, cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived KIPO Seminar 2014 KAIPBA Roadshow 6
Examination Guidelines Overview Three Inquiry Analysis: (1) Is the claim directed to one of the four statutory categories of 35 U.S.C. § 101? Process • Machine • Manufacture • Composition of matter • (2) Does the claim recite or involve a judicial exception? Abstract Ideas • Laws of Nature/ Natural Principles • Natural Phenomena • Natural Product • (3) Does the claim as a whole recite something significantly different than the judicial exception(s)? KIPO Seminar 2014 KAIPBA Roadshow 7
Question (1): Statutory Categories � The claim as a whole is given its broadest reasonable interpretation (BRI) � Not necessary to identify only one particular category � Claimed inventions that do not fall within any statutory category are not patent eligible � If the claims fall within one or more categories, the analysis continues to question (2) KIPO Seminar 2014 KAIPBA Roadshow 8
Question (2): Judicial Exceptions � If the claim recites an abstract idea, it should be analyzed only under MPEP 2106(II) � MPEP 2106(II) controls even if claim recites both an abstract idea and another exception � If the claim does not recite or involve a judicial exception, it qualifies as eligible subject matter � If the claim recites or involves (or may recite or involve) one or more exceptions (other than abstract ideas), proceed to question (3) KIPO Seminar 2014 KAIPBA Roadshow 9
Question (3): "Significantly Different" � Addresses two pathways to eligibility: � Product claim involving or reciting a natural product includes features or steps demonstrating a marked difference from what exists in nature; or � Claim involving or reciting a judicial exception must also recite meaningful limitations that add something of significance to the judicial exception � No bright line rules, flexible application � Factors are to be weighed as, e.g., in a Wands enablement analysis KIPO Seminar 2014 KAIPBA Roadshow 10
Factors Toward Eligibility a) Product claim recites something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products. Claim recites elements/steps in addition to the judicial exception(s) that: b) Impose meaningful limits on the claim scope. c) Relate to the judicial exception(s) in a significant way, e.g., they are more than insignificant extra-solution activity. d) Do more than describe the judicial exception(s) with general instructions to apply/use it. e) Include a particular machine or particular transformation, which implements or integrates the judicial exception(s). f) Add a feature that is more than well-understood, purely conventional or routine. KIPO Seminar 2014 KAIPBA Roadshow 11
Factors Against Eligibility g) Product claim recites something that appears to be a natural product that is not markedly different in structure from naturally occurring products. Claim recites elements/steps in addition to the judicial exception(s) that: h) Are recited at a high level of generality. i) Must be used/taken by others to apply the judicial exception(s). j) Are well-understood, purely conventional or routine. k) Are insignificant extra-solution activity, e.g., are merely appended to the judicial exception(s). l) Amount to nothing more than a mere field of use. KIPO Seminar 2014 KAIPBA Roadshow 12
Factors Fall Into Two Groups � Factors a) and g) are applicable only to product claims � Concerned with the structure of the natural products (test derived from Chakrabarty ) � Factors b) - f) and h) - l) are applicable to all claims � Concerned with whether claim adds additional elements or steps, and whether those elements/steps add significantly more to the judicial exceptions (derived from Mayo ) KIPO Seminar 2014 KAIPBA Roadshow 13
Example A: Natural Product ( Chakrabarty ) Naturally occurring Pseudomonas bacterium: Added plasmids can degrade only one hydrocarbon Genetically modified Pseudomonas bacterium: Bacterial chromosome can degrade four hydrocarbons � Claim 1: A stable energy-generating plasmid, which provides a hydrocarbon degradative pathway � Not eligible because no structural difference, i.e. the claimed plasmid is not markedly different from what exists in nature � Claim 2: A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway � Patent eligible because claimed bacterium is markedly different; structural and functional differences rise to level of markedly different KIPO Seminar 2014 KAIPBA Roadshow 14
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