AIPLA Practical Patent Prosecution Training for New Lawyers

22 August 2013

Biotechnology & Chemical Claim Drafting

Lawrence M. Sung, J.D., Ph.D.

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Discussion

• Differentials –  Application of Patentability Standards –  Enforcement Guidelines –  Disclosure and Claim Drafting Considerations

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Patentability Standards

• Conditions for Patentability – Subject matter & Utility – Novelty – Nonobviousness

• Disclosure Requirements – Written Description – Enablement – Definiteness

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Subject Matter - 35 USC § 101

•  Diamond v. Chakrabarty (1980) – Anything under the sun made by man

•  Bilski v. Kappos (2010) – Machine-or-transformation

•  Mayo Collaborative Servs. v. Prometheus Labs. (2012)

•  Ass’n for Molecular Pathology v. Myriad Genetics (2013)

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Subject Matter - 35 USC § 101

•  Prometheus – a newly discovered law of nature is

unpatentable – the application of a newly discovered law is

also unpatentable if the application merely relies upon elements already known in the art

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Subject Matter - 35 USC § 101

•  Myriad – A naturally occurring DNA segment is a

product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.

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Subject Matter - 35 USC § 101

•  Myriad – The claims are not expressed in terms of

chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Instead, they focus on the genetic information encoded in the BRCA1 and BRCA2 genes.

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Subject Matter - 35 USC § 101

•  Myriad – Myriad did not create or alter either the

genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA.

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Subject Matter - 35 USC § 101

•  Myriad – cDNA creation results in an exons-only

molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.

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Subject Matter - 35 USC § 101

•  Myriad – [This case] does not involve method claims,

patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.

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Utility - 35 USC § 101

•  Brenner v. Manson (1966) – Tumor inhibitory steroid :: Specific

•  In re Fisher (2005) – ESTs/SNPs :: Specific, substantial & credible

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Anticipation - 35 USC § 102

•  Express •  Inherent

– In re Omeprazole Litig. (2007) – Generic Prilosec® :: in situ formation of layer

separating core and enteric coating – Recognition in the prior art not required

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Nonobviousness - 35 USC § 103

•  KSR v. Teleflex (2007) •  Eisai v. Dr. Reddy’s Labs. (2008) •  In re Kubin (2009) •  Daiichi Sankyo Co. v. Matrix Labs., Ltd. (2010)

– lead compound selection

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Written Description - 35 USC § 112

•  Centocor Ortho Biotech, Inc. v. Abbott Labs. (2011) – A mere wish or plan for obtaining the claimed

invention is not sufficient.

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Enablement - 35 USC § 112

•  Biological deposit permissible •  In re Wands (1988)

– Enable any person skilled in the art to make and use the invention without undue experimentation

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Enablement - 35 USC § 112

– Undue experimentation depends upon breadth of the claims; nature of the invention; state of the prior art; level of one of ordinary skill; level of predictability in the art; amount of direction provided by the inventor; existence of working examples; and quantity of experimentation needed to make or use the invention based on the content of the disclosure

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Definiteness - 35 USC § 112

•  If a claim is not insolubly ambiguous (amenable to construction), even though the task may be formidable and the conclusion may be one over which reasonable persons will disagree, the claim is not indefinite.

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Definiteness - 35 USC § 112

•  Hybritech v. Monoclonal Antibodies (1986) – Even if there were no standard set of

experimental conditions which were used to estimate antibody affinities, if the claims, read in light of the specification, reasonably apprised those skilled in the art both of the utilization and scope of the invention, and if the language was as precise as the subject matter permitted, the courts could demand no more.

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Inventorship

•  Conception •  Reduction to Practice

– Actual, constructive, or simultaneous •  Corroboration •  Joint invention (35 USC 116) •  Correction (35 USC 256)

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Enforcement Guidelines

•  Process Patent Infringement – 35 USC 271(g)

•  Product-by-Process Claims •  Clinical Trial Infringement Exemption

– 35 USC 271(e)(1) •  Government Action (28 USC 1498)

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Technology Distinctions

•  Temporal Distortion •  Multiplicity of Purpose •  Dynamic Knowledge •  Nonconforming Nomenclature

•  WHAT IF approach

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Representative Patent Claims

•  Polynucleotides •  Vectors & Host Cells •  rProteins & mAbs •  Diagnostics & Therapeutics •  Microarrays

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U.S. Patent No. 7,402,664

1. An isolated polynucleotide sequence encoding a binding peptide having the amino acid sequence of SEQ ID NO:24, wherein said peptide binds to a carotenoid compound. 2. An expression vector comprising a polynucleotide encoding the phenol oxidizing enzyme-peptide complex comprising the amino acid sequence of SEQ ID NO:24. 3. A host cell comprising the vector of claim 2.

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U.S. Patent No. 7,074,913

7. A vector comprising a non-native expression control sequence operably linked to a polynucleotide selected from the group consisting of the polynucleotide of claim 1 and a polynucleotide of claim 4. 9. A host cell comprising a non-native expression control sequence operably linked to a polynucleotide selected from the group consisting of the polynucleotide of claim 1 and a polynucleotide of claim 4.

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U.S. Patent No. 7,074,913

11. A method for producing an anthrax toxin receptor, the method comprising the steps of: transcribing a polynucleotide operably linked to an upstream expression control sequence, wherein the polynucleotide is selected from the group consisting of the polynucleotide of claim 1 and a polynucleotide of claim 4 to produce an mRNA; and translating the mRNA to produce the anthrax toxin receptor.

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U.S. Patent No. 7,067,636

1. An isolated antibody that specifically binds to the polypeptide of amino acid sequence set forth in SEQ ID NO:466. 2. The antibody of claim 1 which is a monoclonal antibody. 3. The antibody of claim 1 which is a humanized antibody. 4. The antibody of claim 1 which is an antibody fragment. 5. The antibody of claim 1 which is labeled.

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U.S. Patent No. 7,070,935

1. A method for detecting one or more biological entities in a sample, comprising: (a) combining one or more nucleic acid sequences in a sample with multiple primers comprising randomized nucleotide sequences, said randomized sequences being sufficiently randomized such that substantially all of the nucleic acid sequences of a biological entity are represented among amplification products; (b) randomly amplifying the sample nucleic acid sequences to produce nucleic acid amplification products; (c) combining the amplification products with an array of predetermined nucleic acid sequences including redundancies which redundancies comprise multiple distinct nucleic acids from the same target entity and such that at least a portion of the amplification products hybridize to the array; and (d) detecting amplification products that hybridize to the array.

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U.S. Patent No. 6,410,516

1. A method for inhibiting expression, in a eukaryotic cell, of a gene whose transcription is regulated by NF-κB, the method comprising reducing NF-κB activity in the cell such that expression of said gene is inhibited.

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U.S. Patent No. 4,331,803

1.  An erythromycin compound of the formula

wherein R1 is hydrogen or methyl, and a pharmaceutically acceptable salt thereof.

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U.S. Patent No. 5,547,933

4. A non-naturally occurring human erythropoietin glycoprotein possessing the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells which is the product of the process comprising the steps of:

–  (a) growing, under suitable nutrient conditions, mammalian host cells transformed or transfected with an isolated DNA sequence encoding the human erythropoietin amino acid sequence set out in FIG. 6 or a fragment thereof; and

–  (b) isolating a glycosylated erythropoietin polypeptide therefrom.

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U.S. Patent No. 6,551,616

1. A method of reducing gastrointestinal adverse side effects comprising administering an effective amount of an extended release pharmaceutical composition comprising an erythromycin derivative and a pharmaceutically acceptable polymer. 2. The method according to claim 1, wherein the erythromycin derivative is clarithromycin. 3. The method according to claim 2, wherein the composition comprises about 50% by weight of clarithromycin. 4. The method according to claim 3, wherein the composition comprises from about 10 to about 30% by weight of hydroxypropylmethylcellulose having a viscosity of about 100 cps.

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U.S. Patent No. 7,052,834

1. A method for detecting inactivation of a CASP8 gene expression in a primary cancer cell, comprising detecting methylation of CASP8 genomic DNA. 6. A kit for detecting inactivation of a CASP8 gene expression, comprising oligonucleotide primer pairs for amplification of SEQ ID NO: 1 or SEQ ID NO: 2; wherein said primer pairs are oligonucleotides of at least 10 nucleotides that hybridize to SEQ ID NO: 1 or SEQ ID NO: 2 or to complete complements thereof, in a methylation polymerase chain reaction (PCR) assay for the detection of methylation of SEQ ID NO: 1 or SEQ ID NO: 2.

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U.S. Patent No. 7,052,834

8. A method for prognosis of a neuroblastoma comprising detecting inactivation of a CASP8 gene expression in a neuroblastoma cell from a subject, wherein said inactivation of a CASP8 gene expression in the neuroblastoma cell is indicative of the inefficiency of apoptosis induced by activated death receptors, chemotherapeutic drugs, or irradiation, and wherein said method comprises detecting a methylation of CASP8 genomic DNA. 11. A method for diagnosis of an aggressive neuroblastoma comprising detecting inactivation of a CASP8 gene expression in a neuroblastoma cell from a subject, wherein said inactivation of a CASP8 gene expression in the neuroblastoma cell is indicative of the presence of an aggressive neuroblastoma and wherein said method comprises detecting a methylation of CASP8 genomic DNA.

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