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

Biotech Patents and Section 101 Rejections: Meeting Patent Eligibility Requirements

Leveraging Recent Decisions and USPTO Guidance to Overcome Rejections

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THURSDAY, JUNE 8, 2017

Presenting a live 90-minute webinar with interactive Q&A Denise M. Kettelberger , Ph.D., Boston Katherine M. Kowalchyk, Ph.D., Partner, Merchant & Gould, Minneapolis

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2017 7 PATE TENT T EL ELIG IGIBILIT IBILITY IS THE TIDE CHANGING?

JUNE 8, 2017

Denise M. Kettelberger, PhD, JD Patter erso son n Thuente Peder ersen, sen, PA Minneapolis, MN

RECENT DECISIONS QUESTION ALICE & MAYO 2-STEP TEST

5

Alice/Mayo Statistics - Ineligible

■ More than 16,000 claims invalidated ■ 68% of Federal Court Decisions ineligible ■ 92% of Federal Circuit Decisions ineligible ■ 61% of District Court Decisions ineligible ■ 60% of US Patents invalidated ■ 63% decided by motion on pleadings ■ 85% of CBM institutions ■ 98% of CBM final decisions ■ 43% of PGR decisions ■ 36% of ITC decisions

6

Bilski Blog, Robert Sachs

Supreme Court Decisions Applying the Alice/Mayo 2-step Test - Deficient

■ Lacks an objective standar dard d for judging patent-eligibility, ■ Fails to define ne key terms s of the Alice/Mayo test, such as “abstract idea” and “something more”, other than by analogy to patents in prior cases; ■ Fails to provide meaningful ngful and logical guidance nce for how to reach patent- eligibility,” especially for systems/methods involving these so-called “business methods”; ■ Provides conflicti cting ng patent-eligibil gibility y standa ndards ds with respect to their own precedents, particularly of Diamond d v. Diehr and Diamond d v. Chakrabarty; ■ Ignores Congressional intent by overreac aching hing its s consti tituti utiona nal authority rity to interpret (not make) law, including asserting “policy” considerations to support the two-part Alice test that are the province of Congress (not the Supreme Court). ■ Providing no suppo port t in the fa factual al record d before it; and ■ Focuses on an “inventive concept,” improperly comingling ng patent nt-eli eligibil gibility ty under 35 U.S.C. § 101 with patenta ntability y under 35 U.S.C. § 102 and/or 35 U.S.C. § 103.

7

Can the Federal Circuit Stem the Tide?

■ Enfish LLC v. Microsoft Corp ■ TLI Communications LLC v. AV Automotive LLC ■ Rapid pid Litigati ation n Managem gement ent v. Cellz Direct ■ Sequenom quenom v. Ariosa sa ■ McRO, Inc. v. Bandai Nanco Gaming, Inc. ■ Bascom Global Internet Services v. AT&T Mobility ■ Amdocs LTD v Opennet Telecom Inc ■ Thales v U.S.

8

Enf nfish ish v M v Microsof crosoft (822 F3 F3d d 1327,F 7,Fed d Cir 2016)

■ Model for a computer database – All data entries stored in a single, self-referential table with column definitions by rows – Conventional systems store data entries in multiple table – Benefit in faster searching, more effective storage, flexablility ■ CDCA on Summary Judgement, all claims ineligible under §101 – Innovative logical claims held ineligible, anticipated, and non-infringed ■ Federal al Circuit it disagree reed: – Supreme Court did not foreclose the possibility that claims to improveme ment nts in computer existing architecture

• r software may survive Step 1 of the eligibility inquiry

– All claims directed to improvements ments in computer technology, hardware or software, need not be analyzed under the Step 2 inquiry.

9

Rapid pid Litiga gation tion Mgm gmt v. Cellz Dire rect t (Fed (Fed Cir r 2016) 6)

■ …the "inventors certainly discovered ed the cells' ability to survive multiple freeze-thaw cycles ... that is not

• t where they

stopped, nor is it what they patented.“ ■ Instead, the inventors "employed their natural al discovery y to create a new and improved d way of preserving hepatocyte cells for later use." ■ The court held the claims eligible under the first step of the Mayo/Alice framework ■ the "directed ed to" analysis requires more than "merely identifying a patent-ineligible concept underlying the claim" and instead requires s an analysis sis of whether "the end result of the process, the essence of the whole was a patent-ineligible concept." ■ these claims that apply y a law of nature are distinguishable from the claims in Mayo and Sequenom that were found to be directed to a patent-ineligible concept when they "amounted to noth

• thing

ing more than observing ng or identifying the ineligible concept itself

10

McR cRO, , In Inc.

• c. v. Ba

Band ndai ai Namc mco

• Ga

Game mes s Am America ica In Inc.

• c. (Fed.
• d. Cir. 2016)

■ A method for automatically animati ting ng lip synchr chron

• niza

izati tion

• n and facial

expression of three-dimensional characters using sets of rules ■ The claimed invention relates to generating automated lip- synchronization and associated facial expression for 3D animated characters. ■ The inventive rule sets aim to produce more realistic speech by taking into consideration the differences in mouth positions for similar phonemes based on context." ■ Federal Circuit: "the claimed med imp mprovem ement nt here is allowing computers to produce accurate and realistic lip synchronization and facial expressions in animated characters that previously could

• nly be produced by human animators."

■ "[d]efendants provided no evidence that the proces ess previousl iously y us used d by animators is the same as the process required by the claims." ■ Judges Reyna, Taranto, and Stoll

11

Bascom Global Internet Services v. AT&T Mobility (Fed Cir 2016)

■ Method and system for content t filtering ing informatio mation n retrieved from an Internet computer network – the claimed invention is able to provide individually customizable filtering at the remote ISP server by taking advantage of the technical capability of certain communication networks. – no court – not the Supreme Court and not the Federal Circuit – has ever defined the term “abstract idea” or the term “signific icantl antly y more.” – “The district court’s analysis in this case, however, looks similar to an obviousness analysis, explained Judge Chen ■ The inventiv tive concept …“is the installation of a filtering tool at a specific location, remote from the end-users, with customizable filtering features specific to each end user.”

12

Thales v. US (Fed Cir 2017)

■ Claims an inertial ial tracking king system for tracking the motion of an object relative to a moving reference frame ■ Small errors in measuring acceleration and angular velocity translate to large errors in position over time; Known inertial systems include at least one other type of sensor, to correct these errors; The disclosed system can operate independe ependent ntly ■ The equatio ions ns—dictated by the placement of the inertial sensors and application of laws of physics—serve only to tabulat ate the positio ion n and orientatio ation n informa matio tion n in this

• configuration. This arrangement is analogous to the claims

in Diehr. ■ Far from claiming the equations themselves, the claims seek to protect only the application of physics to the unconventional configuration of sensors as disclosed. As such, these claims are not

• t directed

d to an abstrac act t idea and thus the claims survive Alice step one. Because we find the claims are not directed to an abstract idea, we need not proceed to step two

13

Sequenom v Ariosa (Fed Cir 2015)

■ Federal Circuit applied the two-step framework set out in Mayo and Alice – Steps 2A and 2B in the USPTO's subject matter eligibility guidance – Determined the claims were directed d to a a natural al phenomeno

• menon

n (the presence of cffDNA in maternal nal serum

• r plasma),

– not recite an inventiv tive e concept that transforms rms cffDNA into a patentable invention because the amplif ifyi ying ng and det etecting ting steps are routine ne and conventional ional (788 F.3d at 1377). ■ Supreme Court denied cert, leaving Federal Circuit opinion in place. ■ Question – why wasn’t the application of the di disc scovery of cffDNA in maternal blood not held to be an impro roveme ment over the only known method for obtaining fetal DNA samples, the invasive procedure of amniocentesis?

14

Federal Circuit embraces “improvement” inventions as not “abstract”

■ All but one of the Federal Circuit § 101 cases discussed above were found to be eligible for patenting as “improvements” ■ Many life science patents are invalidated as lacking an inventive concept at step 2. Going forward, applicants should stress the improvements made and distinguish the invention from well known products or processes. – Consider if the game-changing inventions of Myriad Genetics, Sequenom, and others would have been eligible for patenting had the Federal Circuit stepped up to defend their patent claims?

15

St Steps ps to Potentially ntially Aid Patent nt El Eligi gibi bility lity

■ DO – Problem/Solution – Compare Product or Process to Prior Known – Specific method steps – Detailed disclosure – Discuss improvements – Identify Gamechangers ■ DON’T – Use General Claim Terms – Claim as Routine & Conventional – Disclose invention generally – Use vague claim terms – Hide new virtues of invention

16

Patentable Subject Matter for Life Sciences

Katherine M. Kowalchyk Merchant and Gould 2017

Agenda

• Review 101 analysis
• Review PTO guidelines and training

materials

• Analyze issued claims/Tips
• Summary of legislative proposals

18

101 Life science court cases

• Mayo Collaborative Servs. v.

Prometheus Labs., Inc., 132 S. Ct. 1289, 1297 (2012): law of nature

• Ass'n for Molecular Pathology v. Myriad

Genetics, Inc., 133 S. Ct. 2107, 2117 (2013): natural product

• Ariosa Diagnostics, Inc. v. Sequenom,

Inc., 788 F.3d 1371 (Fed. Cir. 2015): natural law

19

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

20

Challenges for All: Significant Differences

• Not Patentable Subject Matter: based on case

law 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)

21

PTO Guidelines for the Life Sciences

• Promulgated in December 2014/Updated

examples 28-33 dated May 2016

• “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 – blood glucose levels and diabetes

22

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

23

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

24

Updates Examples 28-33

• Example 28- vaccine attenuated, killed, or with

adjuvant (resulting in a change in property- enhanced seropositivity), or in device

• Example 29-diagnosing and treating julitis-

method of detecting or claiming specific reagents

• Example 30- dietary sweetener with additional

compounds resulting in new properties

• Example 31-Screening for gene alterations-

adding a specific device or cool melt PCR

• Example 32-Paper Making machine improves

process

• Example 33- Hydrolysis of Fat-chemical

transformation

25

New Example 28

• Vaccines attenuated, killed, or with

adjuvant, or in device are eligible

• Not eligible: peptide from virus not

altered other than isolated from virus:

• 3. A vaccine comprising: Peptide F; and a

pharmaceutically acceptable carrier.

26

PTO training on claim 28

• What was invented in each claim? BRI

Claim 3 is a vaccine with isolated peptide F (not altered) in a carrier

• Does it fit in statutory category? Yes
• Is it a nature based product and/or

similar to court cases? Use markedly different characteristics(MDC) compare to natural product in natural state-identify whether the natural product is changed in structure or function

27

PTO training on claim 28

• If no MDC then claim is directed to

judicial exception- peptide F and water no change to structure or function of peptide F so no MDC

• Is there something significantly more?

Inventive concept Significantly more: unconventional material or steps, transformation, combination of elements e.g. use of adjuvant and increase in seropositivity

28

Example 29 PTO analysis

• Diagnosing/treating julitis-diagnosing using

unconventional reagents- porcine abs or specific ab or adding a treating step

• Ineligible: A method of diagnosing julitis in a

patient, said method comprising:

• a. obtaining a plasma sample from a human

patient; b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; and

• c. diagnosing the patient with julitis when the

presence of JUL-1 in the plasma sample is detected.

29

PTO analysis Example 29

• What is invention claimed using BRI?

method of diagnosing julitis

• Is it a statutory category?

Yes-process so no MDC needed

• Is claim directed to an exception?

Yes- like Mayo directed to correlation between presence of Jul-1 and julitis

• Is there significantly more?

Only if unconventional steps or reagents- porcine abs or specific monoclonal or method of treating

30

Tips based on review of PTO analysis

• Consider structuring claims as close as

possible to the examples of eligible claims- avoid claims similar to those found ineligible by the Courts

• Argue that natural product is markedly

different in structure and/or function

• Argue process uses unconventional steps or

reagents or that the combination is unique because of change in property or improvement

• Change to “method of detecting”
• Avoid appeal-likely will lose

31

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

32

101 Rejections

• Detailed diagnostic method claims are issuing
• Need to interview because may be art unit

dependent-most success is interview and RCE

• Appeals not likely to succeed
• Statistics show that art units 1630, 1640,

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

• Art unit 1634-personalized medicine 101

rejections increased to 85% after Mayo

• Highest in bioinformatics, primers,

amplification, haplotyping

33

Claim of 14/750201 allowed (1678)

• 12. A method for diagnosing metabolic syndrome in a subject

comprising:

• a. detecting and quantitating the level of arginine vasopressin pro-

hormone copeptin fragment in a sample from said patient, wherein said detection and quantitation comprises contacting the sample with a diagnostic assay reagent comprising at least one monoclonal antibody or fragment thereof that specifically binds to the arginine vasopressin pro-hormone copeptin fragment at the epitope corresponding to amino acids 132-147 of pre-pro-vasopressin of SEQ ID NO: 1, and detecting and quantitating thus-formed complexes of the antibody or fragment thereof and arginine vasopressin pro-hormone copeptin fragment,

• b. detecting and quantitating at least one other clinical and/or laboratory

parameter associated with the diagnosis of metabolic syndrome, and

• c. correlating the level of the arginine vasopressin pro-hormone copeptin

fragment in conjunction with the at least one other clinical and/or laboratory parameter associated with the diagnosis of metabolic syndrome, with the diagnosis of metabolic syndrome.

34

Arguments in response to 101

• Correlation of combined parameters-copeptin

fragment and one other parameter- is not a natural phenomenon

• Significantly more-improvements to a

technological field-improves diagnosis

• Also combination of measuring the two

parameters not conventional-not known in the art so not conventional

• No preemption-specific combination of

parameters

• Case law not meant to exclude all biomarkers

35

Issued Claims: US 9611511(AU1674)

• A method for detecting a decreased level of at least one

miRNA in a human patient having, or suspected of having, an acute coronary syndrome comprising the steps of: (i) providing a blood cell sample from a human, wherein the blood cell sample is a blood cellular fraction consisting of a mixture of erythrocytes, leukocytes and thrombocytes, and (ii) detecting whether there is a decreased level of the at least one miRNA in the blood cell sample as compared to a control level of a healthy human subject, or a human subject not having or not being suspected of having an acute coronary syndrome, by contacting the sample with at least one probe for at least one down-regulated miRNA and detecting binding between the probe and the down-regulated miRNA; wherein the nucleotide sequence of said at least one down-regulated miRNA is miR-455-3p having SEQ ID NO: 16, or sequence having at least 95% sequence identity thereto.

36

101 arguments

• Argued that claim was amended to similar to

Example 29-amended claim to refer to detecting rather than determining status, also amended to add a specific sequence, other claims as well were amended to specific sequences

• Previous arguments not successful-blood

sample not natural and not used by others in the field-unconventional –examiner cited art to show methods of measuring miRNA in blood cells were known

37

Issued Claims:US9606122(AU1636)

An in vitro method for identifying a human subject having a poor prognosis of 5- year survival of oesophageal and/or gastro-oesophageal junctional (GOJ) adenocarcinoma, the method comprising the steps of: (a) obtaining a tumor tissue sample from said human subject; (b) determining by RT-PCR assay the quantitative expression level of a combination of target genes in said in vitro tumor tissue sample obtained in step (a), wherein the combination of target genes consists of TRIM44, SIRT2, EGFR, and WT1, and the RT-PCR assay utilizes at least one primer selected from the group consisting of SEQ ID NO.1, SEQ ID NO.2, SEQ ID NO.4, SEQ ID NO.5, SEQ ID NO.6, and SEQ ID NO.8; (c) comparing the expression level of each target gene in said combination determined in step (b) with a reference standard for each target gene; (d) detecting an at least 1.3 fold higher level of expression of TRIM44, SIRT2 or EGFR, or an at least 1.3 fold lower level

• f expression of WT1 as compared with said reference standards in step (c),

wherein detecting an at least 1.3 fold higher level of expression of at least one of TRIM44, SIRT2 and EGFR as compared with said reference standards indicates a dysregulated TRIM44, SIRT2 and/or EGFR target gene, and an at least 1.3 fold lower level of expression of WT1 as compared with said reference standard indicates a dysregulated WT1 target gene; and (e) identifying said human subject as having a poor prognosis of 5-year survival of oesophageal and/or GOJ adenocarcinoma based on the dysregulation of at least two of said target genes in said combination consisting of TRIM44, SIRT2, EGFR, and WT1 as detected in step (d).

38

101 Arguments

• Amended the claims to add the specific

primer sequences

• Examiner said adding the specific

sequences to claim overcame the 101 rejection because specificity of claim prevents preemption

• Argued unsuccessfully detecting in vitro

not a natural phenomenon and a limited set

• f specific genes

39

Issued Claims: US9605048 (1647)

• A composition comprising human soluble CD146

protein consisting of SEQ ID NO: 7, wherein said human soluble CD146 protein is acetylated, methylated, phosphorylated or fused to another polypeptide and a pharmaceutically acceptable carrier.

40

101 Arguments

• Amended claim to add the protein was

acetylated, methylated, phosphorylated to add a markedly different characteristic

• 101 rejection without amendment- no

markedly different characteristics

• Most issued claims of proteins are modified

from natural and note the use of term “consisting”

41

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

• btained 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

• f 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.

42

101 Arguments

• 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

43

PTAB decisions

• On appeal PTAB 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

44

PTAB appeal decisions

• Claim in Britz 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?

45

PTAB appeal decisions

• Claims in Khvorova 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

46

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 to argue markedly different characteristics

47

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 For antibodies Examiner must establish identical structure in nature-not possibility

48

Pending Applications

• Argue significantly more :102/103

add a unique step new technology (CRISPR) change in hardware combination not taught in the art resulting in improvement identify unexpected results and put in the feature that leads to these results transformation

49

Pending applications

• Still uncertain
• Examiners application

inconsistent: Interview

• Despite case law –method of

detecting claims have been issued- use Example 29 for guidance

50

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

51

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

52

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

53

New Applications-Methods

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

solvent/extraction, label to molecule

• For natural products, add modification or

component that provides new property

• Add exogenous reagents-claim by specific

sequences-helpful for preemption

• Argue specific combination that provides an

improvement to the diagnostic power

• Combination not found in the art
• Claims should be similar to examples and

not those in cases

54

Legislative Proposals

• IPO/AIPLA proposal: 3 sections
• IPO Eligible subject matter:

(a) Eligible Subject Matter.—Whoever invents or discovers, and claims as an invention, any useful process, machine, manufacture, composition of matter, or any useful improvement thereto, shall be entitled to a patent for a claimed invention thereof, subject only to the exceptions, conditions, and requirements set forth in this Title.

55

Legislative proposals

• Sole Exceptions:
• Sole Exceptions to Subject Matter

Eligibility.—A claimed invention is ineligible under subsection (a) if and

• nly if the claimed invention as a

whole, as understood by a person having ordinary skill in the art to which the claimed invention pertains, exists in nature independently of and prior to any human activity, or exists solely in the human mind.

56

Legislative proposals

• Sole eligibility Standards:
• (c) Sole Eligibility Standard.—The

eligibility of a claimed invention under subsections (a) and (b) shall be determined without regard as to the requirements or conditions of sections 102, 103, and 112 of this Title, the manner in which the claimed invention was made or discovered, or the claimed invention’s inventive concept.

57

Thanks for your time Kathy Kowalchyk

kkowalchyk@merchantgould.com

58