Patent Subject Matter Eligibility: Navigating the New

Patent Subject Matter Eligibility: Navigating the New "Myriad" Guidelines Analyzing Subject Matter and Avoiding Rejection Under the USPTO's Detailed Framework

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WEDNESDAY, APRIL 16, 2014

Presenting a 90-Minute Encore Presentation of the Teleconference with Live, Interactive Q&A

Donna M. Meuth, Associate General Counsel, Eisai, Andover, MA

Leslie McDonnell, Finnegan Henderson Farabow Garrett & Dunner, Boston, MA

Amelia Baur, Finnegan Henderson Farabow Garrett & Dunner, Boston, MA

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Patent Subject Matter Eligibility:

Navigating the New Myriad Guidelines

Analyzing Subject Matter and Avoiding Rejection

Under the USPTO’s Detailed Framework

May 15, 2014

Donna Meuth Leslie McDonell Amelia Baur

6 6

Disclaimer

• These materials are public information and have been prepared

solely for educational and entertainment purposes to contribute to

the understanding of U.S. intellectual property law. These materials

should not be taken as individualized legal advice and do not reflect

the views of FINNEGAN or EISAI, It is understood that each case is

fact-specific, and that the appropriate solution in any case will vary.

Therefore, these materials may or may not be relevant to any

particular situation. Thus, FINNEGAN, EISAI, and the panelists

cannot be bound either philosophically or as representatives of their

various present and future clients to the comments expressed in

these materials. The presentation of these materials does not

establish any form of attorney-client relationship with FINNEGAN,

EISAI, or the panelists. While every attempt was made to insure

that these materials are accurate, errors or omissions may be

contained therein, for which any liability is disclaimed.

7 7

The §101 Roller Coaster

• New guidelines are the USPTO’s sixth

attempt in five years to define patentable

subject matter:

1. August 2009 (machine-or-transformation)

2. January 2010 (computer-readable media)

3. July 2010 (Bilski)

4. July 2012 (Process Claims Involving Laws of Nature; Mayo)

5. June 2013 (Memorandum re Myriad)

6. March 2014 Procedure for Subject Matter Eligibility Analysis of Claims

Reciting or Involving Laws of Nature/Natural Principles, Natural

Phenomena, and/or Natural Products

8 8

Interim Guidelines Released

• 2012 Mayo Guidance; MPEP 2106.01: Process claims

involving Laws of Nature.

• June 13, 2013 Memo – Noted Supreme Court decision in Myriad: claims to isolated DNA

not patent-eligible. • “As of today, naturally occurring nucleic acids are not patent eligible

merely because they have been isolated.”

• March 4, 2014 Memo: New Guidance Replaces Both – “all claims (i.e., machine, composition, manufacture and process

claims) reciting or involving laws of nature/natural principles, natural

phenomena, and/or natural products should be examined using the

Guidance.”

– “examination procedure set forth in the Guidance is effective today

and supersedes the June 13,2013 memo[.]”

9 9

USPTO Guidance to Examiners

• Not a statute

• Important USPTO policy document

– Used to train patent examiners.

10 10

USPTO: The New Subject Matter Eligibility Guidance

• “For use in subject matter eligibility

determinations of all claims (i.e., machine,

composition, manufacture, and process claims)

reciting or involving laws of nature/natural

principles, natural phenomena, and/or natural

products.”

11 11

USPTO: Three-Step Analysis

“walk through the three questions in the flowchart … to

determine whether the claim is drawn to patent-

eligible subject matter. If not, then the claim is prima

facie ineligible, and the claim should be rejected[.]”

12 12


1. Does a claim reciting one of the four statutory

categories of patent eligible subject matter?

(process, machine, manufacture, composition)

2. Does the claim recite or involve one or more

judicial exceptions?

(abstract ideas, laws of nature/natural principles,

natural phenomena, natural products)

3. Does the claim as a whole recite something

significantly different from the judicial exceptions?

13 13


• “Recite or involve” appears to mean -- looks like,

sounds like, smells like, or is somehow derived

from or related to, a natural product, law,

phenomenon -- even if it is but a single component

in a multi-component composition.

• It is not enough that the claim is directed to a

product or composition that is non-naturally

occurring – it must also be significantly different in

structure from naturally occurring products.

14 14


• What does “significantly different” mean?

– Markedly different

– More than nominally, insignificantly, or tangentially related

– More than well understood, purely conventional, or routine in

the relevant field

– Not insignificant extra-solution activity

• Words such as “synthetic”, “isolated”,

“recombinant”+ “cDNA”, “composition”,

“primer”, “purified”, “vector” recited in a claim

do not influence the determination of significant

difference (Guidelines) (added in Training Slides)

15 15

USPTO: How to Analyze “Significantly Different”

• Factor-based analysis of whether claim as a

whole is “significantly different” from the judicial

exception

• Not a single, simple determination, but a

conclusion reached by weighing the relevant

factors, varying the weight accorded each factor

based on the facts of the application

– “[S]imilar to the Wands factor-based analysis”

• On balance, does the totality of the relevant

factors weigh toward eligibility?

16 16

Prometheus: “Significantly Different”

• “A process that focuses on the use of a natural law

also [must] contain other elements...an ‘inventive

concept,’ sufficient to ensure that the patent in practice

amounts to significantly more than a patent upon

the natural law itself.”

‒ Prometheus, citing Flook, Bilski, Diehr

• “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.”

‒ Prometheus

17 17

USPTO Factors – Natural Product

Weigh Against Eligibility Weigh Towards Eligibility

g) claim recites a product that is not markedly different in structure from naturally occurring products

a) claim recites something that is non-naturally occurring and markedly different in structure from naturally occurring products

•Grounded in Chakrabarty? •“Here...the patentee has produced a new bacterium with markedly different characteristics from any found in nature and having the potential for significant utility. His discovery is not nature’s handiwork, but his own.” •The combination of bacteria in Funk Brothers was merely “the handiwork of nature.”

•Grounded in Myriad?

•“Separating [a BRCA] gene from its surrounding genetic material is not an act of invention.” •“cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived...except insofar as very short series of DNA may have no intervening introns”

18 18

USPTO Factors – Preclusion


h) claim recites elements at a high level of generality such that substantially all practical applications of the judicial exception are covered

b) claim recites elements that impose meaningful limits on scope, such that others are not substantially foreclosed from using the judicial exception

•Grounded?

•Precedent “warn[s] us against upholding patents to processes that too broadly preempt the use of a natural law.” – Prometheus, Benson, Flook

•A process must contain other elements “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself” – Prometheus

•Diehr sought only to foreclose the use of an equation in conjunction with all of the other steps of the claimed process – Prometheus

19 19

USPTO Factors – Significant Limits


k) claim recites elements that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception

c) claim recites elements that are more than nominally, insignificantly, or tangentially related to the judicial exception

•Grounded?

•“Flook stands for the proposition that the prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant postsolution activity.’” – Bilski •MPEP 2106 - Use of a machine or apparatus that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.

20 20

USPTO Factors – General/Particular Application


i. claim recites elements that must be used in order to apply the judicial exception

d) claim recites elements that do more than provide general instructions to apply or use the judicial exception

i. claim recites elements that amount to nothing more than a mere field of use

e) claim recites elements that include a particular machine or transformation of a particular article or integrates the judicial exception into a particular practical application

•Grounded in Prometheus? •The three process steps amount “to nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patients.”

•It is not enough to limit the use of the natural law or formula to a particular technological environment ‒ citing Bilski and Diehr

21 21

More Process Cases?

• “[T]he machine-or-transformation test is a useful

and important clue, an investigative tool, for

determining whether some claimed inventions are

processes under §101” ‒ Bilski

• The claimed elements in Mayo are steps that

must be taken by anyone who wants to make

use of the natural law ‒ Prometheus

• Steps in Flook’s process did not limit the claim to a

particular application of the concept of hedging

‒ Prometheus

22 22

USPTO Factors – Well-Understood,

Conventional, Routine


j) claim recites elements that are well-understood, purely conventional or routine in the relevant field

f) claim recites elements that add a feature that is more than well-understood, purely conventional or routine in the relevant field

•Grounded in Prometheus?

•The claimed elements “add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field”

•“[D]etermining” step merely tells doctors to engage in well-understood, routine, conventional activity - citing Flook

23 23

USPTO 12 Factors Weigh Against Eligibility Weigh Towards Eligibility

g) claim recites a product that is not markedly different in structure from naturally occurring products

a) claim recites something that is non-naturally occurring and markedly different in structure from naturally occurring products

h) claim recites elements at a high level of generality such that substantially all practical applications of the judicial exception are covered

b) claim recites elements that impose meaningful limits on scope, such that others are not substantially foreclosed from using the judicial exception

k) claim recites elements that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception

c) claim recites elements that are more than nominally, insignificantly, or tangentially related to the judicial exception

i) claim recites elements that must be used in order to apply the judicial exception

d) claim recites elements that do more than provide general instructions to apply or use the judicial exception

l) claim recites elements that amount to nothing more than a mere field of use

e) claim recites elements that include a particular machine or transformation of a particular article or integrates the judicial exception into a particular practical application

j) claim recites elements that are well-understood, purely conventional or routine in the relevant field

f) claim recites elements that add a feature that is more than well-understood, purely conventional or routine in the relevant field

24 24

USPTO Examples

• Natural Products

• Combination of Natural Products

• Process/Diagnostic Claims

25 25

Example A: Composition Reciting

a Natural Product

• Claim 1: A stable energy-generating plasmid,

which provides a hydrocarbon degradative

pathway.

– Background: Such plasmids exist in nature in

bacteria.

– Analysis:

• Step 1: yes

• Step 2: yes

• Step 3: No. There is no structural difference between the

claimed plasmid and naturally occurring plasmids.

26 26

Example B: Composition Reciting a

Natural Product

• Claim 1: Purified amazonic acid

• Claim 2: Purified 5-methyl amazonic acid

Amazonian cherry tree Amazonic acid

27 27

Example B: Analysis for Purified Natural Product

• Claim 1: Purified amazonic acid

– No marked difference in structure between

purified acid and acid in plant.

– “Isolated”, “recombinant”, “synthetic” do not

confer eligibility.

Not eligible

28 28

• Claim 2: Purified 5-methyl amazonic acid

Example B: Analysis for Laboratory Derivative

of Natural Product

• Recites or involves judicial exception?

Yes, natural product

Analysis:

• Derivative is structurally different from acid in plant.

• Structural difference has created a functional difference.

“[W]hile not necessary to find a marked difference, the presence

of a functional difference makes a stronger case that structural

difference is a marked difference.”

Eligible

29 29

USPTO Examples

• Combination of Natural Products

30 30

Example A: Combination of Natural Products

• Claim 2: A bacterium from the genus Pseudomonas

containing therein at least two stable energy-generating

plasmids, each of said plasmids providing a separate

hydrocarbon degradative pathway.

31 31

Example D: Combination of Natural Products

– Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)

32 32

Claim: A fountain-style firework comprising:

(a) a sparking composition,

(b) calcium chloride,

(c) gunpowder,

(d) a cardboard body having a first compartment containing

the sparking composition and the calcium chloride and a

second compartment containing the gunpowder, and

(e) a plastic ignition fuse having one end extending into the

second compartment and the other end extending out of

the cardboard body.

Example C: Manufacture Claim Reciting Natural Products

(saltpeter, sulfur, charcoal)

33 33

Example C: Manufacture Claim Reciting Natural Products

• The PTO’s analysis is based on “broadest reasonable

interpretation” of “gunpowder” – Type I: A mixture of three naturally occurring materials:

potassium nitrate, sulfur and charcoal. Such a mixture is not

markedly different because none of the components have been changed.

– Type II: A glazed powder formed from four naturally occurring materials:

sodium nitrate, sulfur and charcoal are mixed and then granulated, and

then the granulated particles are coated with a thin layer of graphite. --

This glazed powder is structurally different from what exists in nature,

because the materials have been combined in a particular way to yield a

manufacture that is entirely different from a mere mixture of the raw

materials from which it was formed. In addition, the structural

difference results in a change to the properties of the powder

(it can no longer deliquesce due to the graphite coating). The

USPTO considers this powder to be markedly different from

what exists in nature.

34 34

Training Example: Composition Claim Reciting

Natural Products

2. A beverage composition comprising:

a) 99.5% pomelo juice; and

b) 0.5% vitamin E.

3. A beverage composition comprising pasteurized pomelo juice.


a) pomelo juice; and

b) preservative X [non-natural].


a) pomelo juice; and

b) a preservative.

35 35

Training Example: Alloy

No marked difference: factor (g) satisfied

Marked difference: factor (a) satisfied

•No structural difference

• Mere mixture or aggregation of naturally

occurring metals together as a “composition” does

not change the metals from what exists in nature.

36 36

Training Example: Alloy

Marked difference: factor (a) satisfiedrked difference:

factor (g) satisfied

Marked difference: factor (a) satisfied

•Markedly different in structure: •structural difference (the alloy is a solid solution of tin in copper,

which has a different crystalline arrangement of atoms than in the

natural metals)

•structural difference results in change to properties of alloy (the

alloy has a different color, tensile strength, hardness, and melting

point than either natural metal).

37 37

Example E: Composition Reciting

Two Natural Products

• Claim 1: A pair of primers, the first primer having the

sequence of SEQ ID NO:1 and the second primer having

the sequence of SEQ ID NO:2.

– Consider claim as a whole;

– Not found in nature together;

– Functionally different than individual pieces;

– Application not found in nature.

38 38

Hypothetical Variations

• USPTO has said that primers in a kit are not patent eligible.

• What if the primer pairs are in a test tube with buffer?

• What if the primer pairs are in a test tube with a

nonnaturally occurring buffer?

• What if the primer pairs are bound to their template DNA in

a first step of a PCR reaction?

39 39

You Put Da Lime In Da Coconut

You can drink it all up, but it may not be a patent-

eligible composition!

40 40

USPTO Examples

• Process/Diagnostic Claims

41 41

USPTO Subject Matter Eligibility Training Slides

41

42 42

Example B: Analysis for Method of Using Purified

Natural Product

• Claim 3: A method of treating colon cancer, comprising

administering a daily dose of purified amazonic acid to a

patient suffering from colon cancer for a period of from 10

days to 20 days, wherein said daily dose comprises about 0.75

to about 1.25 teaspoons of amazonic acid

Analysis: • Recites or involves judicial exception?

Yes, natural product

• Significant, non-conventional limitations, limited foreclosure

• Administration step is significant, particular manipulation

• Administration is more than general instruction to use

• Additional elements are more than routine and conventional

Eligible

43 43

Example F: Process Involving Natural Principle

• A method for determining whether a human patient

has degenerative disease X, comprising:

– Obtaining a blood sample from a human patient;

– Determining whether misfolded protein ABC is

present … by contacting the blood sample with

antibody XYZ and detecting ABC … using flow

cytometry…; and

– Diagnosing the patient as having degenerative

disease X if misfolded protein ABC was

determined to be present.

44 44

Example F: Hypothetical Variations

• Flow Cytometry

– March 2014 PTO Training Materials suggest “flow

cytometry” is generic because no description of

whether it is a desk top or high speed machine or the

number of lasers used.

– What if spelled out the steps of flow cytometry, as with

the PCR example?

• Novel Ab vs. Known Ab

– Importing an obviousness analysis

– What if Ab XYZ is the only known Ab, or the only

“commercially viable Ab”?

– Prior USPTO guidelines of July 3, 2012

45 45

Example F: Hypothetical Variations

• Non-routine use of a known product – What makes a reagent or method step conventional?

– The ordering of the steps?

– If a reagent had only been used once before and for an

unrelated assay?

• If the Ab is new, consider removing the

stated natural correlation – A method of detecting mutant protein ABC by contacting

a sample with Ab XYZ.

46 46

Example E: Method Claim Involving Natural

Product

• Claim 2: A method of amplifying a target DNA sequence

comprising:

– Providing a reaction mixture comprising a double-

stranded target DNA, the pair of primers of claim 1…,

Taq polymerase, and a plurality of free nucleotides…

– Heating and cooling the reaction mixture to

predetermined temperatures for predetermined time

periods

– Repeating steps (b) and (c) at least 20 times

47 47

Example E: Hypothetical Variations

• Why is heating to a “predetermined temperature”

for a “predetermined time” considered a narrowing

element?

• What if claim indicated use of “PCR” rather than

spelling out the steps?

• What if claim more generally referred to a

polymerase rather than specifying Taq?

48 48

Reaction from Patent Community

• “USPTO May Reject Wide Range Of Patents Under New

Rules,” IP360, March 5, 2014.

• “10 Problems In The USPTO's New Training Memo,”

IP360, March 10, 2014.

• “Uncertainty Looms as PTO Expands Reach Of Myriad

Genetics Ruling, Attorneys Say,” IPLAW.BNA.COM, March

17, 2014.

• “IP Practitioners ‘Horrified’ By USPTO Guidelines On

Myriad,” Managing IP, March 27, 2014.

49 49

Litigation Update

• District Courts:

– Myriad v Ambry Genetics, Gene-by-Gene, GeneDx, Quest

Diagnostics, InVitae, and Lab Corp of America (D. Utah)

(preliminary injunction denied)

– Ariosa v. Sequenom (N.D. Cal.) (summary judgment granted)

– Genetic Technologies v. Agilent Technologies (N.D. Cal.) (motion to

dismiss denied)

– Genetic Technologies v. BMS, Pfizer, General Genetics

Corporation. Lab. Corp. of America

– Quest Diagnostics and InVitae v. Myriad (N.D. Cal.)

• Federal Circuit:

– In re Roslin Institute

50 50

Affirmative Uses of the New §101 Guidelines

• Licensing – Rely on new §101 interpretation as basis for getting out from under

a usurious license.

• Freedom-to-operate – Revisit invalidity analyses and opinions.

– Consider offensive strategies.

• PGR for recently-filed applications.

• Declaratory judgment possibilities.

• Litigation strategies. – New § 101 defenses available.

51 51

Defenses to §101 Rejections

• Add specificity to claims to narrow “scope of foreclosure” or

“impose meaningful limits on claim scope.”

• Add features that are more than well-understood, purely

conventional or routine to the claims.

• Include a particular machine or particular transfomation to

the claims.

• Recite structural differences between claimed subject

matter and natural product.

• Argue that Examiner has not accorded proper weight to

factors weighing toward eligibility.

52 52

§101 Rejections

• Interpretation of key Supreme Court cases:

• USPTO Guidelines

– “Myriad relied on Chakrabarty as “central to the eligibility

inquiry, and reaffirmed the Office’s reliance on

Chakrabarty’s criterion for eligibility of natural products

(i.e., whether the claimed product is a non-naturally

occurring product of human ingenuity that is markedly

different from naturally occurring products).”

53 53

§101 Rejections

• USPTO Guidelines:

– “Thus, while the holding in Myriad was limited to

nucleic acids, Myriad is a reminder that the

claims reciting or involving natural products

should be examined for a marked difference

under Chakrabarty.”

• Does Chakrabarty hold that a “marked

difference” is necessary to show patent eligibility?

54 54

§101 Rejections

• The only question before the Chakrabarty Court

was whether a living organism is excluded under

§101 from patent eligibility.

• Chakrabarty’s bacteria was found by the Board not

to be a product of nature – this issue was not

appealed by the PTO.

55 55

§101 Rejections

• Chakrabarty’s “markedly different”

– Distinguishing Funk Bros. the Chakrabarty Court

stated “Here, by contrast, the patentee produced a

new bacterium with markedly different

characteristics from any found in nature . . . His

discovery is not nature’s handiwork, but his own,

accordingly it is [patent eligible]”

• Statement of fact vs. required threshold?

56 56

§101 Rejections

• Chakrabarty refers to the invention as a product of

human ingenuity ‘having a distinctive name,

character [and] use.’ Hartranft v. Wiegmann, 121

U. S. 609, 121 U. S. 615” (1887).

• Hartranft v. Wiegmann: “having a distinctive name,

character OR use.”

Hartranft v. Wiegmann

57 57

§101 Rejections

• USPTO Guidelines: – “Myriad also clarified that not every change to

a product will result in a marked difference,

and that the mere recitation of particular words

(e.g., ‘isolated’) in the claims does not

automatically confer eligibility.”

• The Myriad Court refers to “genes and the

information they encode” not being patent

eligible “simply because they have been isolated

from their surrounding material.”

58 58

§101 Rejections

• The Prometheus Court distinguished the claims at issue from claims

directed to a new drug or a new way of using an existing drug.

• PTO agrees that claims to a new way of existing drug do not involve a

law of nature

• PTO indicates that a new way of using a natural product must be

analyzed for patent eligibility

• Do examples suggest that if a natural product is involved, the method

must be limited to narrow applications requiring specific dosages and/or

treatment regimens to avoid foreclosure?

• Myriad Court: “[T]his cases does not involve patents on new

applications of knowledge about the [BRCA] genes.”

59 59

§101 Rejections

• “The Patent Act of 1952 (35 U.S.C.A. §101), as its

predecessors, authorizes a patent for ‘any new and useful

… composition of matter …, provided only that the

conditions for patentability, which are specified in

succeeding sections are met. There is nothing in the

language of the Act which precludes the issuance of a

patent upon a ‘product of nature’ when it is a ‘new and

useful composition of matter’ …”

– Merck & Co. v Olin Mathieson Chemical Corp., 253 F.2d

156 (4th Cir. 1958).

60 60

Internal Portfolio Examination

• Drafting new applications – Disclosure of non-routine or non-conventional modifications.

– Specific methods of use or applications of discoveries.

• Pending applications – Consider multiple layers of claims to account for possible litigation

outcomes and changes in law.

– Identify applications appropriate for appeal.

– Maintain pending applications in important families.

• Issued patents with no pending U.S. counterparts. – Consider scope of issued claims.

– Possible reissue to add dependent claims.

61 61

New Patent Profanity

• Carefully consider use of the following terms:

– In the specification

• Routine

• Conventional

• Well-understood

• Well-known

– In claims

• Analyze

• Compare

• Determine

62 62

Where Does This Leave Us?

• Inconsistent district court decisions

• Even more erratic and inconsistent examination for the

foreseeable future–increasingly reduced predictability,

increasing need to take cases through appeal process.

• Substantially increased uncertainty and IP expense for

biotechnology and other industries that rely on natural

products, methods of diagnosis, or methods of treatment.

63 63

Speaker Information

Leslie McDonell

[email protected] 617.646.1650

Amelia Baur.

[email protected] 617.646.1650

Donna Meuth.

[email protected]

; Tel 617.646.1650

Documents

Patent Subject Matter Eligibility: Navigating the New