Meeting Patent Eligibility Requirements Leveraging Recent Decisions - - PowerPoint PPT Presentation

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Biotech Patents and §101 Rejections: Meeting Patent Eligibility Requirements

Leveraging Recent Decisions and USPTO Guidance to Overcome Rejections

Today’s faculty features:

1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific THURSDAY, MARCH 10, 2016

Presenting a live 90-minute webinar with interactive Q&A Denise M. Kettelberger , Ph.D., Counsel, Sunstein Kann Murphy & Timbers, Boston

• Dr. Katherine M. Kowalchyk, Ph.D., Partner, Merchant & Gould, Minneapolis

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Eligibility Under 35 USC §101 Is the Tide Turning?

Denise M. Kettelberger Sunstein Kann Murphy & Timbers LLP March 10, 2016

Forces of Eligibility §101

• The Statute
• US Supreme Court precedent
• Federal Circuit decisions
• District Court push-back
• USPTO Guidance
• USPTO examination
• Proposed Legislative Reform

5

35 USC Section 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 therefore, subject to the conditions and requirements of this title.

6

Exceptions

• Laws of nature, natural phenomena, abstract ideas

– Neilson v Harford (1841) – LeRoy v Tatham (1853) – O’Reilly v Morse (1854) – Mackay Radio v Radio Corp (1939) – Funk Brothers v Kalo (1948) ______1952 Patent Act______ – Gottschalk v Benson (1972) – Parker v Flook (1978) – Diamond v Chakrabarty (1980) – Diamond v. Diehr (1981) – Bilski v Kappos (2010) – Mayo v Prometheus (2012) – Alice, Myriad, Sequenom, ………….

7

Prometheus v. Mayo - Defining the Exceptions

• Phenomena of nature, though just discovered,

mental processes, and abstract ideas are not patentable, as they are the basic tools of scientific and technological work… (Gottschalk v Benson, 67)

• And monopolization of those tools through the grant
• f a patent might tend to impede innovation more

than it would tend to promote it. (Diamond v Diehr, 187;

quoting Parker v Flook, 590)

• The Court has recognized … that too broad an

interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas. Id.

8

Alice Corp. v CLS Bank, Int’l. – the 2-Step

• Step 1: Is the claim directed to a patent ineligible concept?
• Abstract idea, law of nature, natural phenomenon
• Step 2: Do the elements of the claim transform the nature of

the claim into a patent-eligible application [of the concept]?

• The claim must do more than simply state the law of nature

while adding the words “apply it”. (citing Benson 409 US at 71-72)

• SIGNIFICANTLY MORE

9

USPTO – Significantly More

• improvements to another technology field
• improvements to the functioning of a machine
• judicial exception using a particular machine
• transformation to a different state or thing
• limitation - not well understood, routine, conventional
• Unconventional steps in a particular useful application
• Other meaningful limitations beyond linking the

exception to a particular technological environment

10

The Exception to the Exception

• An application of a law of nature to a known structure or

process may well be deserving of patent protection

(citing Diehr 450 US at 187)

• If there is to be an invention from a discovery of a law of

nature, it must come from the application of the law of nature to a new and useful end. (citing Funk Bros. 333 US at 130)

• Must do more than simply state the law of nature while

adding the words “apply it”. (citing Benson 409 US at 71-72)

• SIGNIFICANTLY MORE

11

Bilski limits Benson, Flook

• Finally in Diehr, the Court established a limitation on the principles

articulated in Benson and Flook.

• The application in Diehr claimed a previously unknown method for

molding raw, uncured synthetic rubber into cured precision products using a mathematical formula to complete some of its several steps by way of a computer.

• Diehr explained that while an abstract idea, law of nature, or

mathematical formula could not be patented, “an application of a law of nature of a mathematical formula to a known structure or process may well be deserving of patent protection.” (Bilski at p.14,

citing Diehr at 187).

12

Diehr – Eligible Flook – Not Eligible

• The patentees did not seek to preempt the use of the

equation, but “only to foreclose from others the use of that equation in conjunction with all the other steps in their claimed process.” Diehr, slip opinion, 12

• Lacking specificity, the claims recite nothing other than

“providing an unpatentable formula for computing an updated alarm limit.” citing Flook at 586.

13

Myriad Genetics – Not Eligible

A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18, or 19 in a human which [method] comprises: analyzing a sequence of a BRCA1 gene or BRCA1 RNA [or cDNA] from a human sample _____________________? with the proviso that said germline alteration is not a deletion of 14 nucleotides corresponding to base numbers 4184-4187

US 5709999 Myriad Genetics

14

Myriad Genetics – Eligible?

A method for diagnosing the presence of breast cancer in a subject, comprising the steps of:

a) isolating a BRCA1 gene, RNA or cDNA from a sample of the subject’s

tissue or cells and determining the nucleic acid sequence of the isolated gene, RNA, or cDNA; b) analyzing the isolated sequence to detect the presence of a germline alteration in a BRCA1 gene selected from the group consisting of the alterations set forth in Tables 12A, 14, 18, or 19 in the subject’s gene, RNA, or cDNA, With the proviso that said germline

alteration is not a deletion of 14 nucleotides corresponding to base numbers 4184-7; and

c) providing a diagnosis of breast cancer where one or more of said germline alterations is detected.

.

15

Ariosa Diagnostics v. Sequenom 2016

• Fed Cir 2016, en banc reh’g denied
• “Our hands were tied and it’s up to the

U.S. Supreme Court to fix this”

– “[I]t is undisputed that before this invention, the amplification and detection of cffDNA from maternal blood, and use of these methods for prenatal diagnosis, were not routine and conventional. – But applying Mayo, we are unfortunately obliged to divorce the additional steps from the asserted natural phenomenon to arrive at a conclusion that they add nothing innovative to the process.” Judge Lourie

16

Ariosa v. Sequenom, enbanc denied Federal Circuit Pushes Back

• Judge Newman’s dissent:

– Decision mandated by Supreme Court –wrongly decided – product and metabolites known in Mayo, leaving sparse room for

innovative advance in use as diagnostic

– Here the method was not known, nor the diagnostic knowledge and benefit implemented by the method

• "Precedent does not require that all discoveries of natural phenomena
• r their application in new ways or for new uses are ineligible for

patenting“

17

Ariosa v. Sequenom, enbanc denied Federal Circuit Pushes Back

18

• Judge Linn: the breadth of the 2nd part is unnecessary to

the decision in Mayo – this case represents the consequences – perhaps uninteded - excluding a meritorious invention from the patent protection it deserves…

• Judge Lourie: It is unsound to have a rule that takes

inventions of this nature out of the realm of patent- eligibility on grounds that they only claim a natural phenomenon plus conventional steps, or that they claim abstract concepts.

• Judge Dyk: …a too restrictive test for patent eligibility

with respect to laws of nature may discourage development and disclosure in the life sciences which are often driven y discovery of new natural laws… we are bound by the language of Mayo…

Eastern District of Texas – Eligible!

• Content Guard Holdings v. Amazon.com and Google

– Patents relate to systems/methods controlling use of digital works – Motion for Summary Judgement characterized the claims as: “nothing more that enforcing usage rights and restrictions on digital content - the abstract idea of enforcing sublicensing rights”

• ED TX disagreed:

– In Alice, the Court reiterated the right of inventors to obtain patents as codified in §101, this section contains implicit exceptions – Laws of nature, natural phenomenon, abstract ideas are not eligible

• “Courts must distinguish between claims to building blocks of human

ingenuity and those that integrate the building blocks into something more, thereby transforming to an eligible invention“

19

101 Legislative Options?

• Eligible: application to a new and useful end
• Addition to 101:

– Claimed subject matter that is useful, shall not be denied eligibility for patenting on the ground that it is directed to a law of nature, natural phenomenon, or abstract idea.

• Get rid of 101:

– The inventor of a discovery in the useful arts that is new under section 102 and non-obvious over section 103 and is described and enabled under section 112 shall be entitled to a patent therefor.

Next Steps?

• Apply the natural law in your claims
• Push back in USPTO Appeals
• Give the Federal Circuit cases to change 101
• Educate legislators to the need for change
• Support with Amicus briefs!
• Write persuasive articles in public press

Patentable Subject Matter for Life Sciences

Katherine M. Kowalchyk Merchant and Gould 2016

Agenda

• Review 101 analysis and guidelines
• Analyze issued claims
• Look at recent appeal decisions
• Tips

23

101 Lessons

• Does the subject matter of the claim include

new and useful process, machine, manufacture, or composition of matter

• Is the claim directed to an exception

natural law, product, or abstract idea

• Compare application of the natural law or

product to that which occurs in nature to find differences

• Something More :Inventive Concept

new steps, new result, new technology, new characteristics

• Preemption: Are there alternatives

24

Challenges for All: Significant Differences

• Not Patentable Subject Matter:

primers, methods of comparing sequences not tied to a purpose or a specific set of mutations, identification of a dosage, diagnostic methods (list natural law and apply it- conventional techniques)

• Markedly Different: structure or function or both
• Inventive concept:102/103 analysis

combination of ordered steps, combination of products or product that lends new features, changes in structure, specifically identified changes that are tied to a purpose(genetic mutations)

25

PTO Guidelines for the Life Sciences

• Promulgated in December 2014
• “Laws of Nature” and “Natural

Phenomena” include natural principles, naturally occurring relations or correlations that occur without a hand of man,

• Natural product: a substance found or

derived from nature

• Examples:

– The law of gravity – The disinfectant qualities of ultraviolet light – The relationship between blood glucose levels and diabetes

26

Examples

• Gunpowder-combination of three

naturally occurring chemicals-eligible

• Pomelo juice plus preservative-

eligible(different properties)

• Amazonic acid and methods of

treatment eligible as long as amazonic acid has a structural difference or is combined with another component

• Purified protein having a different

crystal structure or different glycosylation-eligible

27

Examples

• Genetically engineered bacterium with

new function-eligible

• Bacterial mixture with new properties-

eligible

• Nucleic acid with 1 change, a label, or a

vector-eligible

• Antibodies that are human or

humanized, claimed by CDRs, with variants-eligible

• Stem cells with unique marker-eligible
• Food product with different property

28

Issued Claims

• Nucleic acid claims-specific

sequences in claims have issued

• Polypeptide variant claims have

issued

• Polypeptide conjugated with

heterologous moieties

• Dimers of monomers-different forms

29

101 Rejections

• Detailed diagnostic method claims are

issuing

• Need to interview because may be art

unit dependent

• Statistics show that art units 1630,

1640, 1650, and 1660 have 20-50% OA with 101 rejections

• Highest in bioinformatics, primers,

amplification, haplotyping

30

Issued claims: US9234901(AU 1777)

• A method for detecting the presence or amount of pyridoxal 5'-

phosphate in a body fluid sample by tandem mass spectrometry, comprising: (i) purifying said sample, wherein purifying comprises: (a) applying a body fluid sample and a first solvent to an extraction column under conditions suitable to reversibly retain pyridoxal 5'-phosphate on said extraction column; (b) applying a second solvent to said extraction column under conditions suitable to elute retained pyridoxal 5'-phosphate from the extraction column, wherein said first and second solvents are different; (c) applying eluted pyridoxal 5'-phosphate from the extraction column to an analytical column for chromatographic separation; and (d) applying a third solvent to said analytical column to elute pyridoxal 5'-phosphate from the analytical column; (ii) generating a parent ion of said pyridoxal 5'-phosphate from said purified sample; (iii) generating one or more daughter ions of said parent ion; and (iv) detecting the presence or amount of one or more said ions generated in step (ii) or step (iii) or both, and relating the detected ions to the presence or amount of said pyridoxal 5'-phosphate in said sample.

31

Tips for Drafting and Claiming

• Add a particular machine-tandem

mass spec

• Add a non natural element:

solvent/extraction

• For natural products, use chemical

name (active form of vitamin B6)

• No 101 rejections raised in case and

case went to appeal no new rejection

• n 101 entered

32

Issued Claims: US 9234895(AU1678)

A method for detecting perturbation of a normal biological state of an organ in a subject comprising, (a) contacting a blood sample from the subject with a plurality of detection reagents each specific for an

• rgan-specific protein secreted into blood, wherein the

plurality of detection reagents comprises at least 10 detection reagents, wherein each organ-specific protein is secreted from the same organ; (b) measuring the amount of the organ-specific protein detected in the blood sample by each detection reagent; (c) comparing the amount of the organ-specific protein detected in the blood sample by each detection reagent to a predetermined control amount for each respective organ-specific protein; wherein a statistically significant altered level in

• ne or more of the organ-specific proteins indicates a

perturbation of the organ in the subject.

33

Tips

• Be a famous inventor- this has Leroy Hood

listed as inventor

• Add exogenous reagents-use term reagent

without specifying

• Is ten different reagents enough?
• Include predetermined control- always

describe the control and how the comparison is done

• 101rejection overcome by arguing case law

and indicating that the class of proteins was not previously used to diagnose

34

Issued Claims:US9234890(AU1637)

A method for the detection of PSA, said method comprising: (a) providing a first binding member comprising a monoclonal antibody directed to a first epitope on prostate specific antigen coupled to a first single-strand nucleic acid and a second binding member comprising a monoclonal antibody directed to a second epitope on prostate specific antigen coupled to a second single- strand nucleic acid, wherein the first single-strand nucleic acid hybridizes to the second single-strand nucleic acid, thereby forming a binding pair that is linked through a nucleic acid duplex; (b) contacting the binding pair with a sample, wherein the sample comprises PSA in a solution, thereby forming a binding pair- PSA complex; (c) heating the binding pair-PSA complex to dissociate nucleic acid duplexes; (d) incubating the binding pair-PSA complex under conditions that permit reassociation of binding members bound to PSA, but does not allow substantial reassociation of excess free binding members in the solution; (e) detecting binding pair duplexes, thereby detecting PSA.

35

Tips

• Define a unique reagent even combining

two different natural products

• Use the term binding partner

36

Issued Claims: US 9228237 (AU1634)

A method of detecting a deletion mutant cystic fibrosis transmembrane (CFTR) nucleic acid in an individual, comprising: (a) contacting a biological sample comprising a CFTR nucleic acid from an individual with a detectably labeled nucleic acid probe that specifically hybridizes to a mutant CFTR nucleic acid comprising the deletion mutation but not to a wild-type CFTR nucleic acid; and the probe comprises the deletion mutation; and (b) detecting the CFTR deletion mutation in the individual when a hybrid is formed between the detectably labeled nucleic acid probe and the mutant CFTR nucleic acid, wherein the deletion mutation is selected from the group consisting of c.2817.sub.-- 2821del and c. 1066.sub.--1071 del.

37

Tips

• Use detectably labelled reagent
• Provide a specific sequence or set of

sequences

• The specific sequence was important in
• vercoming a 101 rejection based on Ambry

case pointing to claim 21 that was directed to detecting a specific set of mutations

38

US 9274128(AU 1674)

A method to diagnose Parkinson's disease in a subject comprising the steps of: extracting nucleic acid from a test sample obtained from the subject; measuring an amount of a component in a test sample obtained from the subject, wherein the component is selected from the group consisting of Parkin Interacting Substrate (PARIS), a metabolite of Parkin interacting Substrate (PARIS), an mRNA coding for Parkin Interacting Substrate (PARIS), peroxisome proliferator-activated receptor gamma coactivator 1-.alpha., (PGC-1.alpha.), and an mRNA coding for PGC-1.alpha., using at least one primer pair selected from the group consisting of: (a) a first primer pair consisting of a reverse primer consisting of SEQ ID NO: 120 and a forward primer consisting of SEQ ID NO: 119; (b) a second primer pair consisting of a reverse primer consisting of SEQ ID NO: 32 and a forward primer consisting of SEQ ID NO: 31; and (c) a third primer pair consisting of a reverse primer consisting of SEQ ID NO: 76 and a forward primer consisting of SEQ ID NO: 75; determining the expression of the component; and comparing the amount of the component against a baseline expression value to determine whether the levels of ….. are reduced as compared to levels of a healthy subject.

39

Tips

• Specific primers listed in the claim
• 101 rejection argued specific steps

were not at a high level of generality and that some steps were not occurring in nature

40

PTAB decisions

• On appeal PPTAB affirms PTO on

101 more often than not

• PTAB can remand with a new 101

rejection

• Ex Parte Judith Britz et al., decision

2/10/2016-AU 1644 claims ineligible

• Ex Parte Khvorova et al, decision

7/13/2015-AU1631-claim ineligible

41

Claim Ineligible:PTAB decision

A method of monitoring an immune response in a patient receiving one or more immunosuppressive drugs, comprising the steps of: at first and second time periods, determining a value of an immune response for said patient which reflects activation of one of CD3, CD4, CD19, or CD56 lymphocytes in a whole blood sample stimulated by exposure to a mitogen wherein said value is measured in terms of adenosine triphosphate (ATP) present in cell lysate of said one of CD3, CD4, CD19 or CD56 lymphocytes isolated from said stimulated blood sample, said patient receiving said one or more immunosuppressive drugs between said first and second time periods, said second time period being one day to one month after said first time period, wherein said patient is a non- transplant patient that has at least one of Crohn’s disease, cancer, inflammation, rheumatoid arthritis, or lupus erythmatosus; comparing said value determined at said first time period with said value determined at said second time period, and if there is a decrease of at least 50 ng/ml ATP, determining that said patient is at risk of being overmedicated with said one or more immunosuppressive drugs.

42

PTAB appeal decisions

• Claim found to be too similar to the

claim in Mayo because the additional steps were conventional in the art

• Taking samples at different time

period were known

• Applying a mitogen to sample was

known from a previous test- the additional steps are evaluated for novelty –is this new?

43

Ineligible Claim :PTAB A method for obtaining an siRNA sequence for a target gene, wherein said siRNA sequence comprises 19 – 30 nucleotide bases, said method comprising the steps: (a) selecting a target gene; (b) generating a set of candidate siRNA sequences that are between 19 and 30 bases in length,….

44

PTAB appeal decisions

• Claims characterized as identifying

rules of predicting siRNA sequences that will silence genes

• Distinguishes Diehr as no

transformation

• Silencing genes is a natural

phenomenon- other steps?

• Other steps well known as specific

algorithm not in claim or even the 4 variables mentioned

45

Pending Applications

• Argue that the claim is not directed

to a natural product or law method of treatment (limited by preemption) combinations or formulations with natural and non natural components with different function or property use of a natural product not directed to natural product per se

46

Pending Applications

• Argue markedly different in structure
• r function or both

structural change crystal structure with different function glycosylation/post translational Label or tag combination with heterologous sequence combination with new property combination that does not occur together product by process if structure can be assumed Examiner must establish identical structure in nature-not possibility

47

Pending Applications

• Argue significantly more :102/103

add a unique step new technology (CRISPR) change in hardware

• rdered combination of steps

identify unexpected results and put in the feature that leads to these results transformation

48

Pending applications

• Still uncertain
• Examiners application

inconsistent: Interview

• No guidance on methods of

screening/diagnostic because of case law- file continuation applications if your specification does not provide options

49

New applications

• Search what is known in the art so

you can know how to characterize the natural product in its natural state in background so you can distinguish

• Build in variants that have at least
• ne change as a specific set of

mutations can be claimed

• Describe any post translation or

glycosylation changes based on production in a cell type. Include product by process claims

50

New applications

• Describe conjugates- molecules

tagged with a label or purification tag

• Describe compositions and

formulations-highlight new functions or properties based on components of composition or formulation

• Describe vectors and host cells

51

New applications

• Describe method of treatment

claims

• Build the case for 102/103 and

include any unexpected results

• Tie unexpected results to a

structural and/or functional feature if you can

• Consider negative disclaimers
• Trade secrets

52

New Applications-Methods

• Add a particular machine-tandem mass spec
• Add a non natural element:

solvent/extraction

• For natural products, use chemical name
• Be a famous inventor
• Add exogenous reagents-use term reagent

without specifying

• Is ten different reagents enough?
• Identify a specific set of changes in natural

molecule

53

New Applications: Methods

• Include predetermined

control- always describe the control and how the comparison is done

• Define a unique reagent even

combining two different natural products

• Use the term binding partner
• Use detectably labelled

reagent

54

Thanks for your time Kathy Kowalchyk

kkowalchyk@merchantgould.com

55

DISCUSSION

Thank you!

56

Denise M. Kettelberger Sunstein Kann Muirphy & Timbers LLP dkettelberger@sunsteinlaw.com