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2014 KAIPBA Roadshow KIPO Seminar 2
Presented by: Sunhee Lee & Mihsun Koh - - - PowerPoint PPT Presentation
Presented by: Sunhee Lee & Mihsun Koh - - - PowerPoint PPT Presentation
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
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Background: Mayo v. Prometheus (2012)
2014 KAIPBA Roadshow KIPO Seminar 3
→ (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.”
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Mayo v. Prometheus (cont'd)
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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. ”
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Background: AMP v. Myriad (2013)
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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"
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AMP v. Myriad (cont'd)
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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
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Examination Guidelines Overview
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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)?
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Question (1): Statutory Categories
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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)
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Question (2): Judicial Exceptions
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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)
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Question (3): "Significantly Different"
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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
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Factors Toward Eligibility
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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.
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Factors Against Eligibility
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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.
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Factors Fall Into Two Groups
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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)
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Example A: Natural Product (Chakrabarty)
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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
Bacterial chromosome Added plasmids
Naturally occurring Pseudomonas bacterium: can degrade only one hydrocarbon Genetically modified Pseudomonas bacterium: can degrade four hydrocarbons
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Example: Myriad
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Claim 1: Isolated BRCA1 gene
Non-naturally occurring because the isolated DNA is a "stand alone" molecule,
versus natural form in a chromosome
However, ineligible because no marked difference in structure
Claim 2: cDNA formed by two exons from BRCA1 gene
Non-naturally occurring, natural gene includes both exons and introns Also markedly different in structure because different nucleotide sequence, thus
it is patent eligible
BRCA1 gene Exon 1 Exon 2 Intron
Claimed cDNA
Exon 1 Exon 2
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Example D: Composition Reciting Multiple Natural Products (Funk Brothers)
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Claim:An inoculant for leguminous plants comprising a plurality of selected
mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific.
- Ineligible. None of the bacteria are markedly different; bacteria are structurally identical
to naturally occurring bacteria 1 1 2 2 3 3 4 4 5 5 Claimed Inoculant Naturally occurring Rhizobium bacteria
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Public Comments
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Guidance is inconsistent with Supreme Court precedent and §
101
Function must be considered in addition to structure
Chakrabarty refers to "characteristics" which include more than just structure
Overly broad application
Supreme Court explicitly limited its Myriad holding Should only apply to claims that, as a whole, are drawn or directed to an exception,
not any claim that merely "involves" an exception, e.g. treatment method claims Under new Guidance, cDNA would reach question (3) and could be
found ineligible
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Public Comments (cont'd)
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Undue restrictions will stifle innovation
Biotech/Pharma industries will suffer Contrary to constitutional goals
Guidance creates uncertainty
Legal instability of patent rights, some may be found invalid Too few examples, inconsistent results Patent eligibility should accessible by all parties
Expensive and burdensome to respond to a 12-factor analysis rejection Guidance is not in accordance with international harmonization efforts
May even violate international agreements, such as TRIPS
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Public Comments (cont'd)
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Examples B and C (from Guidance) raised issues for many
commenters
In Ex. B, Purified amazonic acid should be eligible due to functional
difference from naturally occurring plant (would need to eat 30 lbs of leaves per day to get same effect)
There need not be a per se exclusion of purified natural products
Guidance suggests that the modified 5-methyl amazonic acid would be
eligible regardless of whether it functions differently
Example C states that gun powder (a mixture of naturally occurring
saltpeter, sulfur, and charcoal) is not markedly different from what
- ccurs in nature
Combinations that do not structurally alter the natural products should still be eligible
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USPTO’s Exemplary Claims Presented in 2014 Bio International Convention
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- 1. Isolated nucleic acid comprising a sequence that has at least 90%
identify to SEQ ID NO: 1 and contains at least one sequence modification relative to SEQ ID NO: 1.
- 2. Polypeptide comprising an amino acid sequence that has at least 90%
identity to SEQ ID NO: 2 and contains at least one sequence modification relative to SEQ ID NO: 2.
- 3. A nucleic acid comprising SEQ ID NO: 1 and a fluorescent label
attached to the nucleic acid.
- 4. A chimeric or humanized antibody to Antibiotic L.
- 5. Purified Antibiotic L.
- 6. Antibiotic L, which is expressed by recombinant yeast.
- 7. A human or fully human antibody to Antibiotic L.
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USPTO’s Exemplary Claims Presented in 2014 Bio International Convention – Factual Assumption
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Antibiotic L is a naturally occurring protein produced by a particular
bacterial species. It exhibits antibiotic activity in nature (e.g., it kills
- ther bacterial species in its natural environment).
SEQ ID NO: 1 is the naturally occurring DNA sequence that encodes
Antibiotic L.
SEQ ID NO: 2 is the naturally occurring amino acid sequence of
Antibiotic L.
Some "fluorescent labels" are naturally occurring. Antibodies to Antibiotic L are naturally occurring in wild coyotes, but
not in humans or mice.
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THANK YOU
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