Patent Eligibility and Engineered Natural...

Patent Eligibility and Engineered Natural

ProductsOvercoming 101 Challenges, Leveraging Options to Obtain IP Protection

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TUESDAY, JANUARY 15, 2019

Presenting a live 90-minute webinar with interactive Q&A

Virginia L. Carron, Partner, Finnegan Henderson Farabow Garrett & Dunner, Atlanta

Jessica L.A. Marks, Attorney, Finnegan Henderson Farabow Garrett & Dunner, Reston, Va.

Erin M. Sommers, Ph.D., Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

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Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Patent Eligibility and

Engineered Natural Products

Implications from Myriad Genetics and

Seqenom

66


Impossible Burger, Beyond Meat, Just Inc.

(formerly Hampton Inc.)

Plant-based meat market to reach $5B by

2020 MarketsandMarkets

Dairy alternatives expected to make up 40%

of the ‘milk’ market by 2021 Innova Market Insights

• In 2017, milk alternative sales were

up 3.1% while cow’s milk sales were

down 5% Nielsen

Dairy alternative market projected to be

$19.5B by 2020 MarketsandMarkets

77


Vegan Leathers:

• Made from pineapples, mushrooms,

kombucha

Faux leather market predicted to reach $85B

by 2020 Grand View Research, Inc.

Indoor agriculture:

Vertical farming projected to

be $13B by 2024Global Market Insights, Inc.

88

Investment in Sustainable Technologies

99

Top Food Patent Applicants - 2016

1010

Statutory Definition of Patent—35 U.S.C. Sec. 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.

1111

Claim Types

• 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.

1212

Historic Case Law

– Ex parte Latimer

• 1889 Dec. Comm‘r Pat. 123 (1889)

• Not patent eligible

• Natural products are “common stock”

– Parke-Davis & Co. v. H.K. Mulford Co.

• 189 F. 95 (C.C.S.D.N.Y. 1911)

• Judge Learned Hand

• Patent eligible

• Extraordinary utility of isolated and purified

product overcame the exclusion

• Isolated and Purified Exception

1313

Historic Case Law

• Made by Man or Nature?

– Funk Brothers Seed Co. v. Kalo Inoculant Co.

• 333 U.S. 127, 130 (1948)


• “[W]ork of nature”; no species acquired a different property or

use

1414

Historic Case Law

• Made by Man or Nature?

– Diamond v. Chakrabarty

• 447 U.S. 303 (1980)

• Patent eligible

• “[A]nything under the sun that is made by man”

1515

Myriad

• Ass’n for Molecular Pathology v. Myriad

Genetics Inc.

– 569 U.S. 576 (2013)

– An isolated DNA coding for a BRCA1 polypeptide, said

polypeptide having the amino acid sequence set forth in

SEQ ID NO:2. (Isolated gene)

– The isolated DNA of claim 1, wherein said DNA has the

nucleotide sequence set forth in SEQ ID NO:1. (cDNA)

1616

Myriad

• Ass’n for Molecular Pathology v. Myriad

Genetics Inc.

– 569 U.S. 576 (2013)

– An isolated DNA coding for a BRCA1 polypeptide, said

polypeptide having the amino acid sequence set forth in

SEQ ID NO:2. (Isolated gene)


– The isolated DNA of claim 1, wherein said DNA has the

nucleotide sequence set forth in SEQ ID NO:1. (cDNA)

• Eligible

1717

Post-Myriad Cases

• In re: BRCA1- and BRCA2- Based Hereditary

Cancer Test Patent Litigation

– 774 F.3d 755, 760 (Fed. Cir. 2014)

– Not Patent Eligible

– DNA primers were “structurally identical to the ends of

DNA strands found in nature”

1818

Post-Myriad Cases

• Exergen Corp. v. Kaz USA, Inc.

– 725 F. App'x 959 (Fed. Cir. 2018)

– Patent Eligible

– “[T]he patent is directed to the measurement of a natural

phenomenon (core body temperature). Even if the

concept of such measurement is directed to a natural

phenomenon and is abstract at step one, the

measurement method here was not conventional,

routine, and well-understood.”

1919

Post-Myriad PTAB Decisions

• Ex parte Sheau Yu Hsu

– 2016 WL 7474845 (PTAB Dec. 19, 2016)

– Not patent eligible

– “[N]either naturally occurring compositions of matter, nor

synthetically created compositions that are structurally

identical to the naturally occurring compositions, are

patent eligible.”

2020

Post-Myriad PTO Guidance

• PTO 2014 Guidance

– Federal Register, Vol. 79, No. 241, Dec. 16, 2014

2121



– Three-step analysis

• Step 1

• Step 2A

• Step 2B

2222



– Step 1

2323



– Step 2A

2424



– Step 2B

2525



– Option for Streamlined Analysis

• for a claim that “clearly does not seek to tie up any judicial

exception such that others cannot practice it”

– Examples:

• “an artificial hip prosthesis coated with a naturally occurring

mineral”

• claims that “merely include ancillary nature-based components,”

such as “a cellphone with an electrical contact made of gold.”

2626


1. Gunpowder and Fireworks

2. Pomelo Juice

3. Amazonic Acid, Pharmaceutical

Compositions, & Methods of

Treatment

4. Purified Proteins

5. Genetically Modified Bacterium

6. Bacterial Mixtures

7. Nucleic Acids

8. Antibodies

9. Cells

10. Food

https://www.uspto.gov/sites/default/files/documents/mdc_examples_nature-

based_products.pdf

2727


1. Gunpowder and Fireworks

Gunpowder comprising: an intimate finely-ground mixture of 75%

potassium nitrate, 15% charcoal and 10% sulfur.

A fountain-style firework comprising: (a) a sparking composition, (b)

calcium chloride, (c) the gunpowder of claim 1, (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.

2828


2. Pomelo Juice

A method comprising providing a pomelo fruit.

A beverage composition comprising pomelo juice and an effective

amount of an added preservative.

2929


10. Food

A kit for preparing goat milk yogurt comprising: Streptococcus

thermophilus and Lactobacillus alexandrinus.

A yogurt starter culture comprising: goat milk mixed with Streptococcus

thermophilus and Lactobacillus alexandrinus.

3030


28. Vaccines

29. Diagnosing and Treating Julitis

30. Dietary Sweeteners

31. Screening For Gene Alterations

32. Paper-Making Machine

33. Hydrolysis of Fat

https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf

3131


28. Vaccines

A vaccine comprising live attenuated Pigeon flu virus.

A vaccine comprising inactivated Pigeon flu virus.

A vaccine comprising Peptide F; and a pharmaceutically acceptable carrier.

A vaccine comprising Peptide F; and a pharmaceutically acceptable carrier

selected from the group consisting of a cream, emulsion, gel, liposome,

nanoparticle, or ointment.

A vaccine comprising Peptide F; and an immuno-effective amount of an

aluminum salt adjuvant.

A vaccine comprising Peptide F; an immuno-effective amount of an

aluminum salt adjuvant; and a pharmaceutically acceptable carrier.

A vaccine delivery device comprising a microneedle array that is coated

with a vaccine comprising Peptide F.comprising inactivated Pigeon flu

virus.

3232


30. Dietary Sweeteners

A dietary sweetener comprising texiol; and water.

A dietary sweetener comprising 1-5 percent texiol; and at least 90

percent water.

A dietary sweetener comprising 1-5 percent texiol; at least 90 percent

water; and 1-2 percent Compound N.

A dietary sweetener comprising 5 percent texiol; water, fruit juice, or a

combination of water and fruit juice; and sufficient amounts of pectin to

provide a solid gel.

A dietary sweetener comprising granular particles of texiol having a

particle diameter of X10 of 80 microns and X90 of 300 microns.

A dietary sweetener comprising texiol in a controlled release formulation.

3333

Post-Myriad Cases

• Vanda Pharm. Inc. v. West-Ward Pharm. Int'l

Ltd.

– 887 F.3d 1117 (Fed. Cir. 2018)

– Patent Eligible

– Method of treating patient suffering from schizophrenia

based on genetic testing

3434


• Vanda Memorandum– www.uspto.gov/sites/default/files/documents/memo-vanda-

20180607.PDF

• Addresses the limited question of how to evaluate the patent eligibility

of "method of treatment claims" in light of the Federal Circuit decision in

Vanda

(1) "method of treatment" claims that practically apply natural relationships

should be considered patent eligible under Step 2A of the USPTO's

subject matter eligibility guidance; and

(2) it is not necessary for "method of treatment" claims that practically apply

natural relationships to include nonroutine or unconventional steps to be

considered patent eligible under 35 U.S.C. § 101.

3535

Post-Myriad Cases

• Berkheimer v. HP Inc.

– 881 F.3d 1360 (Fed. Cir. 2018)

– Some claims ineligible; Remanded for other claims

– Whether a claim element or combination of elements

would have been well-understood, routine, and

conventional to a skilled artisan in the relevant field at a

particular point in time is a question of fact

3636


• Berkheimer Memorandum– www.uspto.gov/sites/default/files/documents/memo-berkheimer-

20180419.PDF

• Examiner must expressly support a rejection in writing with:

– A citation to an express statement in the specification or to a statement made by an

applicant during prosecution that demonstrates the well-understood, routine,

conventional nature of the additional element(s).

– A citation to one or more of the court decisions discussed in MPEP § 2106.05(d)(II)

as noting the well-understood, routine, conventional nature of the additional

element(s).

– A citation to a publication that demonstrates the well-understood, routine,


– A statement that the examiner is taking official notice of the well-understood, routine,


3737

Post-Myriad Claims

3838

Post-Myriad Claims

3939

Post-Myriad Claims

4040

Post-Myriad Claims

4141

Post-Myriad Claims

4242

Post-Myriad Claims

4343

Post-Myriad Claims

4444

Post-Myriad Claims

4545

Post-Myriad Claims

4646

The Future of § 101

• New USPTO Guidance

– Federal Register, 50 Vol. 84, No. 4, January 7, 2019

– “[A]pplies to all applications, and to all patents resulting

from applications, filed before, on, or after January 7,

2019”

– Written comments due March 8, 2019

– https://www.federalregister.gov/documents/2019/01/07/2018-

28282/2019-revised-patent-subject-matter-eligibility-guidance

4747


• New USPTO Guidance

– Abstract Ideas:

• (a) Mathematical concepts

• (b) Certain methods of organizing human activity

• (c) Mental processes

– Revised Step 2A:

• (1) Whether the claim recites a judicial exception; and

• (2) Whether a recited judicial exception is integrated into a

practical application.

4848


• New Legislation

– December 2018 – Closed-door Senate meeting

– https://www.law360.com/articles/1112205/sens-appear-keen-on-

drafting-new-patent-eligibility-law

4949

Best Practices

• Product Claims

• Other Claim Types

• Arguments to Consider

5050

Thank You!

Virginia L. Carron

[email protected]

Jessica L.A. Marks

[email protected]

Erin M. Sommers

[email protected]

5151

Disclaimer

These materials are public information and have been prepared solely

for educational purposes to contribute to the understanding of American

intellectual property law. These materials reflect only the personal

views of the authors and are not individualized legal advice. 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, the authors and

Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P. 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, Henderson, Farabow,

Garrett & Dunner, L.L.P., or with the authors. 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.

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