PATENTABILITY OF DIAGNOSITC

INVENTIONS

Disclaimers

2

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provide legal advice to any individual or entity. Please consult

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which it may cite.

UNLESS OTHERWISE STATED

Who is this guy?

MARCUS A. STREIPS

Attorney-Advisor (Intellectual Property)

United States Army Medical Research & Materiel Command

Fort Detrick, MD

What inventions are patentable?

• An invention can be patented if:

– The invention is eligible for patenting (“patentable subject matter”), and

– 35 USC §101

– The invention meets other statutory conditions (e.g., “new” and

“unobvious” as measured against the prior art)

– 35 USC §§102, 103, 112

What Inventions are not Patentable?

• Abstract ideas

– Mental processes

• Physical phenomena

• Laws of nature

– Abstract mathematical formulas or pure algorithms

– Inventions that clearly do not work

• Perpetual motion machines

OBVIOUSLY NOT PATENTABLE

OR IS IT SO OBVIOUS?

A method and system for placing an order to purchase

an item via the Internet. The order is placed by a

purchaser at a client system and received by a server

system. The server system receives purchaser

information including identification of the purchaser,

payment information, and shipment information from the

client system. The server system then assigns a client

identifier to the client system and associates the

assigned client identifier with the received purchaser

information. The server system sends to the client

system the assigned client identifier and an HTML

document identifying the item and including an order

BUTTON. The client system receives and stores the

assigned client identifier and receives and displays the

HTML document. In response to the selection of the

order button, the client system sends to the server

system a request to purchase the identified item. The

server system receives the request and combines the

purchaser information associated with the client

identifier of the client system to generate an order to

purchase the item in accordance with the billing and

shipment information whereby the purchaser effects the

ordering of the product by selection of the order button.

What is this a patent for?

Amazon.com 1-Click

A portable communication device with

multi-touch input detects one or more

multi-touch contacts and motions and

performs one or more operations on an

object based on the one or more multi-

touch contacts and/or motions. The object

has a resolution that is less than a pre-

determined threshold when the operation is

performed on the object, and the object

has a resolution that is greater than the

pre-determined threshold at other times.

What is this a patent for?

Apple Pinch to Zoom

OK, but surely nothing that

violates the Laws of Physics? Right?

AND ITS NOT JUST PATENTS

What is “Patentable Subject Matter”?

• 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.

Patent Act of 1952 (35 USC §101)

Along comes the Bilski Decision

• Decided June 28, 2010

• The opinion offers little clarity in determining whether a particular invention falls within the scope of Section 101.

“Today, the Court once again declines to impose limitations on the Patent Act that are inconsistent with the Act’s text. The patent application here can be rejected under our precedents on the unpatentability of abstract ideas. The Court, therefore, need not define further what constitutes a patentable “process,” beyond pointing to the definition of that term provided in §100(b) and looking to the guideposts in Benson, Flook, and Diehr.”

Practical Effect

Must take each case, one case at a time and compare with old cases.

Prometheus Rising

(some background)

Prometheus Rising Prometheus Rising is a book by Robert Anton Wilson first

published in 1983. It is a guide book of "how to get from here to there", an amalgam of

Timothy Leary's 8-circuit model of consciousness, Gurdjieff's self-observation

exercises, Alfred Korzybski's general semantics, Aleister Crowley's magical theorems,

Sociobiology, Yoga, relativity, and quantum mechanics amongst other approaches to

understanding the world around us. Source: http://en.wikipedia.org/wiki/Prometheus_Rising

Our “Prometheus Rising” is a lot

more complicated

At the time the patents were filed, scientists already understood

that the levels in a patient's blood of certain metabolites were

correlated with the likelihood that a particular dosage of a

thiopurine drug could cause harm or prove ineffective. But they

did not know the precise correlations between metabolite levels

and likely harm or ineffectiveness. The patent claims at issue here

set forth processes embodying researchers' findings that identified

these correlations with some precision.

Prometheus Rising

(some background)

Prometheus’ Patents

Prometheus’ Patents

• U.S. Patents 6,355,623 and 6,680,302

• methods for calibrating the proper dosage of thiopurine

drugs used for treating both gastrointestinal and non-

gastrointestina l autoimmune diseases (Crohn’s Disease).

Prometheus’ Patents

Claim 1 of the ‘623 patent:

“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising” two steps

“(a) administering” one of a class of drugs (thiopurines) (“a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder;”) and

“(b) determining the level of” a specified metabolite (“6-thioguanine in said subject having said immune-mediated gastrointestinal disorder”),

“wherein” a level below a given threshold (“the level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells”) “indicates a need to increase the amount of said drug subsequently administered to said subject and”

“wherein the level” above the threshold (“6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells”) “indicates a need to decrease the amount of said drug subsequently administered to said subject.”

“A method of optimizing therapeutic efficacy, comprising:

“(a) administering a drug; and

“(b) determining the level of 6–T

“wherein the level of 6–thioguanine less than [X] indicates a need to increase the amount of said drug subsequently administered to said subject and

“wherein the level of 6–thioguanine greater than [Y] indicates a need to decrease the amount of said drug subsequently administered to said subject.”

Said another way . . .

Source: www.law.berkeley.edu/files/3_-_8-30-2012_-_101_Part_2.ppt, © Board of Regents – University of California

Supreme Court follow up to Bilski

• Mayo v. Prometheus Labs

– On June 29, 2010, the Supreme Court granted cert., vacated the

decision and remanded the case to the Federal Circuit

• The Federal Circuit was instructed to reconsider the case “in light

of Bilski v. Kappos, 561 U.S. ____ (2010).”

– On March 20, 2012, the Supreme Court issued the unanimous decision

that:

• No patents for claims that do not do “significantly more than simply

describe natural relations.” No 10-1150, 566 U.S. __ (2012).

[T]he claims inform a relevant audience about certain laws of nature; any

additional steps consist of well-understood, routine, conventional activity

already engaged in by the scientific community; and those steps, when viewed

as a whole, add nothing significant beyond the sum of their parts taken

separately. For these reasons we believe that the steps are not sufficient to

transform unpatentable natural correlations into patentable applications of

those regularities.

Prometheus Falling

(S.Ct. Mayo Decision)

– Monopolization of laws of nature, mental processes and abstract

intellectual concepts through the grant of a patent might tend to impede

innovation more than it would tend to promote it.

– An application of a law of nature or mathematical formula to a known

structure or process may be deserving of patent protection.

– However, to transform an unpatentable law of nature into a patent-eligible

application of such a law, one must do more than simply state the law of

nature while adding the words “apply it.”

Prometheus Falling

(S.Ct. Mayo Decision)

Relationship to Flook and Diehr

The claim before us presents a case for patentability that is weaker than

the (patent-eligible) claim in Diehr and no stronger than the

(unpatentable) claim in Flook. The claimed instructions 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

Parker v. Flook, 437 U.S. 584 (1978) “Method for Updating Alarm

Limits” (on catalytic converters).

Diamond v. Diehr, 450 U.S. 175 (1981) “[process] for molding raw,

uncured synthetic rubber into cured precision products."

See the similarity?

Court’s analysis based on Diehr & Flook

Diehr process – patentable

Method for molding raw, uncured rubber

into cured, molded products.

The process

(1) continuously monitoring the

temperature on the inside of the mold,

(2) feeding the resulting numbers into a

computer, which would use the

Arrhenius equation to continuously

recalculate the mold-opening time, and

(3) configuring the computer so that at

the appropriate moment it would signal a

“device” to open the press.

Flook process – not patentable

Method for improved system for adjusting

“alarm limits” in the catalytic conversion

of hydrocarbons.

The process

(1) measuring the current level of the

variable, e.g., the temperature;

(2) using an apparently novel

mathematical algorithm to calculate the

current alarm limits; and

(3) adjusting the system to reflect the

new alarm-limit values.

Source: www.law.berkeley.edu/files/3_-_8-30-2012_-_101_Part_2.ppt © Board of Regents – University of California

Court’s analysis based on Diehr & Flook

Diehr process – patentable

The combination of steps was NOT

obvious, already in use or purely

conventional.

The additional steps of the process

integrated the equation into the

process as a whole.

Flook process – not patentable

The steps of the method were well-

known to the point that, putting the

formula to the side, there was no

“inventive concept” in the claimed

application of the formula.

The process did not limit the claim to

a particular application.

Source: www.law.berkeley.edu/files/3_-_8-30-2012_-_101_Part_2.ppt © Board of Regents – University of California

“A method of optimizing therapeutic efficacy, comprising:

“(a) administering a drug; and

“(b) determining the level of 6–T

“wherein the level of 6–thioguanine less than [X] indicates a need to increase the amount of said drug subsequently administered to said subject and

“wherein the level of 6–thioguanine greater than [Y] indicates a need to decrease the amount of said drug subsequently administered to said subject.”

Back to this . . .

Source: www.law.berkeley.edu/files/3_-_8-30-2012_-_101_Part_2.ppt © Board of Regents – University of California

Court’s analysis of the claims

Analysis of the claims went through four steps:

• 1. the Court observed that the administering step just defines “the relevant

audience”—doctors who treat patients with thiopurine drugs.

• 2. “the ‘wherein’ clauses simply tell a doctor about the relevant natural

laws.”

• 3. the determining step does not specify any particular process, but merely

invites doctors “to engage in well understood, routine, conventional activity.’

• 4. “to consider the three steps as an ordered combination adds nothing to

the laws of nature that is not already present when the steps are considered

separately.”

Source: www.law.berkeley.edu/files/3_-_8-30-2012_-_101_Part_2.ppt © Board of Regents – University of California

Court’s Conclusion

• Concluded that these instructions 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; and

• the steps of the method, when viewed as a whole, add nothing significant

beyond the sum of their parts taken separately.

• The effect of the steps is simply to tell doctors to apply the law of nature

somehow when treating their patients.

Source: www.law.berkeley.edu/files/3_-_8-30-2012_-_101_Part_2.ppt © Board of Regents – University of California

Looking Ahead - Tips

• In process or method claims and in new applications include

– elements or combinations of elements which themselves comprise an

“inventive concept”

• not “well-understood, routine, and conventional activity already

engaged in by the scientific community”

– additional transformative step which include

• an assay component

• quantification techniques

• treatment protocols

Source: www.lowndes-law.com/site/.../jason_miller_ip_presentation_on_mayo.ppt © Lowndes, Drosdick, Doster,

Kantor & Reed, P.A.

Looking Ahead - Tips

• In process or method claims and in new applications include

– active steps which will be more difficult to identify as “laws of nature”

• novel determinative steps

• what is administered is novel

• the relationship between what is detected and a particular disease is

novel

– multiple, additional known steps must add something “significant” as a

whole, beyond the sum of their parts

Source: www.lowndes-law.com/site/.../jason_miller_ip_presentation_on_mayo.ppt © Lowndes, Drosdick, Doster,

Kantor & Reed, P.A.

Thank You!

Source:

http://en.wikipedia.org/wiki/File:PrometheusRisingCover.jpg