Issac Patent Eligibility Presentation Mid Winter Orlando 2015

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American Intellectual Property Law Association

More Fun with §101 – A Prosecution Perspective

for Biotechnology Derived Innovation

Roy P. Issac, Ph.D., J.D.

IP Practice in Japan – Pre-Meeting at AIPLA Mid-Winter Institute

Orlando, Florida

January 27, 2015

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Disclaimer

This presentation is intended for educational

purposes only. It is not intended to convey legal

advice pertaining to any particular situation and is

not a substitute for legal advice.

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USPTO Guidance: A Streamlined Approach

• Product claims– Apply the markedly different

characteristics test (Chakrabarty test)

– If the claims do not meet the Chakrabarty test, apply the

significantly more test from Myriad.

• Process/Method claims–Apply the Mayo/ Alice test

Well-understood

Routine

Conventional

Inventive concept

Significantly more

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Myriad v. Ambry Uses the Same Bifurcated Approach

• Soon after the PTO Guidance was published, the Federal

Circuit’s opinion in Myriad v. Ambry was issued.

• Case involved product claims directed to primers and

method claims directed to screening for BRCA1 mutation

by comparing a patient’s gene sequence with a germline

BRCA sequence.

• Both sets of claims were held patent ineligible.

• The Court applied the Chakrabarty approach for primers

and the Mayo/Alice approach for the method claims.

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PTO Guidance: Focus on pre-emption

• Determine whether an element in the claim

directed to a law of nature, natural phenomenon or

abstract idea will tie-up the subject matter and pre-

empt others from using the judicial exception.

• Argue how the additional elements in the claim

limit the law of nature, natural phenomenon or

abstract idea such that not all uses are pre-

empted.

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PTO Guidance: For products, apply the markedly

different characteristics test

• Dissection Analysis: The markedly different characteristics test

is applied to the nature-based product limitations, not for the

claim as a whole.

• However, care should be taken not to overly extend the

markedly different characteristics analysis to products that when

viewed as a whole are not nature-based.

• Changes that are incidental to isolation is not enough.

• E.g. A claim directed to an artificial hip prosthesis coated with a

naturally occurring mineral is not an attempt to tie up the mineral.

Here, the claim is analyzed as a whole and determined that the

prosthesis when viewed as a whole is not nature-based.

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PTO Guidance: Markedly Different Characteristics

• Difference in structure, function and/or other properties

• Even a small change can result in markedly different

characteristics.

• Purified or isolated products will be eligible when there is a

resultant change in characteristics sufficient to show a marked

difference.

• Biological/ pharmaceutical function or activities

• Chemical or physical properties

• Phenotype including functional and structural characteristics

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Examples of Nature-Based Products That Will Likely Meet

the Markedly Different Characteristics Test

• Genetically modified organisms (Diamond v. Chakrabarty)

– Organisms that have been modified to be genetically different from

any natural organism such as e.g. insertion of vectors encoding and

expressing one or more exogenous genes.

– Organisms that have been modified to be biologically or

phenotypically different from any natural organism in the absence of

genetic engineering e.g. organisms subjected to different growth

conditions resulting in some phenotypic difference or cloned

animals having a phenotypic difference such as altered telomeres.

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• cDNA (AMP v. Myriad Sup. Ct. 2013)

– Nucleic Acids

• Non-naturally occurring nucleic acid sequences of a native

sequence wherein one or more nucleotides have been modified

(e.g. tagged nucleic acids, modified bases), deleted, inserted,

substituted) such that there is no naturally occurring counterpart.

• Codon optimized nucleic acid sequences of native nucleic acid

sequences so long as the codon optimized sequence is not

identical to any native sequence.

• Nucleic acids having modified internucleotide linkages (e.g.

phosphorothioate internucleotide linkages).

• Vectors that are not identical to naturally occurring plasmids.

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– Proteins

• Non-naturally occurring crystal structures of natural proteins

• Non-naturally occurring glycosylation of natural proteins

• Unglycosylated forms of natural proteins (such as a eukaryotic protein

produced in a prokaryotic cell).

• Non-naturally occurring amino acid sequences of natural proteins

resulting from e.g. amino acid substitution, insertion deletion, or

presence of a non-naturally occurring or chemical modified amino acid.

• Non-naturally occurring fusion proteins (e.g. recombinantly produced

fusion proteins of two different genes not otherwise found fused

together in nature).

• Circularly permuted proteins (e.g. wherein the amino acid structure of a

proteins is altered to provide a new N- and C-terminus).



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– Cells

• Cells that are genotypically different from any naturally occurring

cell

• Cells that are phenotypically different from any naturally occurring

cell

• Combinations of naturally occurring cells and unnaturally

occurring cells resulting in different biological properties of the

combination.

• Hybrid plants (J. E. M. Ag Supply v. Pioneer Hi-Bred Sup. Ct. 2001)

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PTO Guidance: Significantly More

• If the markedly different characteristics test cannot be met

for the claim element directed to nature-based product,

apply the significantly more test from Myriad.

• Do additional elements add significantly more?

• Is there an element or a combination of elements sufficient

to ensure that the claims amount to significantly more than

the judicial exception?

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PTO Guidance: Significantly More

• What types of additional elements will be considered

sufficient to meet the significantly more test is not clear.

• It is also not clear whether conventional elements can meet

the significantly more standard.

– For instance, will buffers or carriers in a pharmaceutical formulation

be considered sufficient to meet the significantly more standard for

a formulation containing a nature-based product.

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• Does any element, or combination of elements, in the claim

is sufficient to ensure that the claim amounts to significantly

more than the judicial exception.

– Here the claim elements are analyzed by dissecting the judicial

exception out of the claim and determining if the additional elements

add sufficiently more.

• Inventive concept: Does the claim as a whole amount to

significantly more than the exception itself?

– Claim is analyzed as a whole.

– “It is important to consider the claim as a whole. Individual

elements viewed on their own may not appear to add significantly

more to the claim, but when combined may amount to significantly

more than the exception.”

PTO Guidance: Method Claims

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Back to the Myriad v. Ambry Decision

• The Court held that claims directed to short single stranded

DNA primers were not patent eligible since they were

“structurally identical to the ends of DNA strands found in

nature.”

• In case of screening method claims, the Court determined

that the additional elements apart from the DNA sequence

itself were directed to “well-understood, routine and

conventional activity.”

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Myriad v. Ambry: Primers

• Primers are not distinguishable from the isolated DNA

found patent-ineligible in Myriad.

• Structurally identical to the ends of DNA strands found in

nature.

• No weight given to the fact that the sequences are

synthetically replicated.

• Separating DNA from its surrounding genetic material is not

an act of invention.

• Myriad argued that primers have fundamentally different

function than when the sequence is part of the DNA strand.

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• However, the Court found that the naturally occurring

sequences do not perform a significantly new function.

• “A DNA structure with a function similar to that found in

nature can only be patent eligible as a composition of

matter if it has a unique structure, different from anything

found in nature.”

Myriad v. Ambry: Primers

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Claim 7: A method for screening germline of a human subject for an alteration of a BRCA1 gene which

comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from

said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences

of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the

sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an

alteration in the BRCA1 gene in said subject[,]

wherein a germline nucleic acid sequence is compared by hybridizing a BRCA1 gene probe which

specifically hybridizes to a BRCA1 allele to genomic DNA isolated from said sample and detecting the

presence of a hybridization product wherein a presence of said product indicates the presence of said

allele in the subject.

“Do the patent claims add enough to their statements of the

correlations to allow the processes they describe to qualify as

patent-eligible processes that apply natural laws?”

Myriad v. Ambry: Screening Method Claims

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• Are “the remaining elements, either in isolation or

combination with the other non-patent-ineligible elements,

sufficient to “transform the nature of the claim” into a

patent-eligible application.”

• Abstract mental steps are not enough.

– Compare

– Analyze

– Determine

• The first paragraph of the claim is directed to patent

ineligible abstract idea of comparing BRCA sequences and

determining the existence of alterations.


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• Methods directed to identification of alterations of the gene,

require merely comparing the patient’s gene with the wild-

type and identifying any differences.

• The number of covered comparisons is unlimited.

• The covered comparisons are not restricted by the purpose

of the comparison or the alteration detected.


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• The second paragraph of the claim adding particular

mechanisms of comparison are analyzed to see if they

transform the claim into a patent-eligible application.

• Additional elements

– Hybridizing a BRCA gene probe

– Detecting the presence of a hybridization product

– Amplification of BRCA1 gene

– Sequencing amplified nucleic acids

• Additional elements “do not add enough to make the claims

as a whole patent-eligible.”


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• Additional elements are not enough because, they “set

forth well-understood, routine and conventional activity

engaged in by scientists at the time of Myriad’s

applications.”


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Back to PTO Guidance: Examples of Nature-Based

Products That Meet Patent Eligibility Requirements

• Combinations of nature-based products that exhibit new

functionality or characteristics

– Gunpowder where new functional characteristics of explosiveness

is not present in individual ingredients.

• Combinations of nature-based product with additional

agents that provide additional characteristics

– E.g. Pomelo juice with added preservatives.

• Formulations with nature-based product

– E.g., Amazonic acid with solubilizing agent

• Method of treating cancer with nature-based product

– E.g., Treating cancer with amazonic acid.

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• Purified proteins

– Purified antibiotics

– Proteins expressed in recombinant yeast

– Proteins with point mutations

• Genetically modified bacterium

• Bacterial mixtures

– If the combination provides a mixture with additional

functional properties.

• Nucleic acids

– At least one substitution or modification compared to that

exists in nature.

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• Antibodies

– E.g. Human antibodies to bacterial protein.

• Cells

– E.g. Isolated human pacemaker cell expressing marker Z

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Take Home Points

• Product claims are largely governed by the “markedly different

characteristics” test.

• Determine when to analyze the claim as a whole and when to

focus on the nature-based product element.

• Have a series of narrow claims that add additional claim

elements that specify methods of characterizing, comparing etc.

• Determine if the changes to a nature-based product is “merely

incidental to isolation.”

• AMP v. Myriad may be limited to cases where the changes for a

nature-based product are those “merely incidental to isolation.”

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Acknowledgements

Carolyn Elmore, Esq.

Darlene Vanstone, Esq.

Mahreen Hoda, Esq.

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Questions?

Roy P. Issac, Ph.D., J.D.

Elmore Patent Law Group, P.C.

484 Groton Rd.

Westford, MA 01886

978.251.3501

[email protected]

Name

Issac Patent Eligibility Presentation Mid Winter Orlando 2015

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