patent256New model93New design1091

21

DDT

21

21

2012: 2-9-3

24 X

genetic engineeringDNADNAelementssequence or partial sequence of gene

98/44/EC5elements

2012: 2-2-2

25 9625

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35 U.S.C. 101.Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title."

Patentable Subject Matterpatent-eligibility

laws of nature physical phenomena and abstract ideas

Diamond v. ChakrabartyChakrabartymarkedly distinctive different

Bilskimachine-or-transformation testSupreme Court's decision in Bilski, which rejected this court's machine-or-transformation test as the exclusive test for determining whether an invention is a patent-eligible process under 101, although the test remains "a useful and important clue." 130 S. Ct. at 3227.

machine-or-transformation test 1it is tied to a particular machine or apparatus2it transforms a particular article into a different state or thing

Prometheus201220123Prometheus

1 administering2 determining3 whereinId, at 1290-91

genuine applications

Myriad2013DNA(isolated DNA)DNAcDNA

What is Gene ?DNA is chemical information database; genes are the working subunits of DNA and chromosomes are the large amount of coiled DNA. David Darling, Beyond 2000: Genetic Engineering

Central Dogma Transcription & SplicingThe conversion of DNA to mRNA is a 2-step process:Pre-mRNA synthesizedsplicinghttp://www.nature.com/horizon/rna/background/figs/splice_f1.htmlExon: functional part, will translate to proteins.Intron: do not directly code for proteins.

The cDNA Production Man-made2-step cDNA preparing:Reverse transcriptionRemoved RNADifference between cDNA and natural DNA:Have no intronsShorterDifferent chemical structureScott F. Gilbert, Developmental Biology 9th edition Ch4: Techniques of Molecular Biology

Difference Between Isolated DNA and cDNAGenomic Law Report, "Myriad, Finally: Supreme Court Surprise by not surprising", 2013

isolated DNAComplementary DNADefinitionIsolated from the natural DNAcDNA is defined as synthetically created DNAContentisolatedremoved and separated from its natural environment in the cell.contains the same protein-coding information found in natural DNA but omits portions that do not code for proteins.

2012: 2-14-3

2014 Alice v. CLS Bank20146Alice v. CLS Bank

Alice5,970,479479 6,912,510 7,149,7207,725,37547933settlement riskfinancial exchange

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inventive conceptsignificantly more

additional feature

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*So, what is gene? We just mentioned that thing at the previous slide; I suppose most of you have no idea about it.Human cells contain two sets of chromosomes; each set contains 23 molecules of double-stranded DNA. One set inherited from your mom and the other from your dad.The chromosomes contain tightly coiled strands of DNA and genes are sections of DNA that contain the code for making proteins-the building block of life. Now we go back to our title, what is gene? Genes are the working subunits of DNA.Briefly saying, DNA is a kind of chemical information database: genes are the working subunits of DNA and chromosomes are the large amount of coiled DNA. *This slide will talk about more transcription details cause we need to discuss two type of DNA: the isolated DNA and cDNA for the following patent issue.This knowledge will help you understand the concept of cDNA much easier.The conversion of DNA to mRNA is a two-step process.Introns and exons both are parts of DNA sequence. Exons are functional part and will translate to proteins, whereas introns do not.The second step called splicing, the introns will be spliced out and exons will be stuck together.Look here, this mRNA sequence has no introns, only exons, you can compare this two sequences.*In order to prepare cDNA, the process will carry on reverse transcription with a reverse transcriptase which is first found in virus.Then removed the RNA strand with strong base, we got a cDNA strand.Therefore, we found that the difference between cDNA and natural DNA with three points:cDNA have no introns.Remove the introns makes cDNA much shorter so that the researcher can look into the sequence, as introns can span thousands of base pairs.Natural DNA usually accompany with some structural protein to confirm the stability on giant molecule, but cDNA do not need that.As you can see, there are some markedly different between natural DNA and cDNA, which made cDNA becomes man-made product, not natural.*The table will help you distinguish isolated DNA and cDNA more clearly.Isolated DNA is isolated from the natural DNA, but cDNA is defined as synthetically crated which means man made.Isolated means removed and separated from its natural environment in the cell. The DNA is purified and isolated from the body, but it still comes from natural.And cDNA contains the same protein-coding information found in a segment of natural DNA but omits portions that do not code for proteins. In other words, cDNA sequence is different from the natural DNA, the details well discuss later.*