No. 08-964 
In The Supreme Court of the United States 
BERNARD L. BILSKI AND RAND A. WARSAW, 
Petitioners, 
v. 
JOHN J. DOLL, ACTING UNDER SECRETARY OF 
COMMERCE FOR INTELLECTUAL PROPERTY AND ACTING 
DIRECTOR, PATENT AND TRADEMARK OFFICE,  
Respondent. 
ON WRIT OF CERTIORARI TO THE UNITED STATES 
COURT OF APPEALS FOR THE FEDERAL CIRCUIT 
BRIEF OF AMICUS CURIAE MEDTRONIC, INC. 
IN SUPPORT OF NEITHER PARTY 
 
 
Lawrence M. Sung 
Michael J. Jaro 
Counsel of Record 
Noreen C. Johnson  
Jeff E. Schwartz 
Girma Wolde-Michael 
Dewey & LeBoeuf, LLP 
Medtronic, Inc. 
1101 New York 
710 Medtronic  
  Avenue, NW 
  Parkway, NE 
Washington DC 20005 
Minneapolis MN 55432 
(202) 346-8000 
 
Attorneys for Amicus Curiae 
LEGAL PRINTERS  LLC, Washington DC !   202-747-2400 !   legalprinters.com

 

QUESTIONS PRESENTED 
1. Whether the Court of Appeals for the Federal 
Circuit erred by holding that a “process” must be 
tied to a particular machine or apparatus, or 
transform a particular article into a different state 
or thing (“machine-or-transformation” test), to be 
eligible for patenting under 35 U.S.C. § 101, despite 
this Court’s precedent declining to limit the broad 
statutory grant of patent eligibility for “any” new 
and useful process beyond excluding patents for 
“laws of nature, physical phenomena, and abstract 
ideas.” 
2. Whether the Federal Circuit’s “machine-or-
transformation” test for patent eligibility, which 
effectively forecloses meaningful patent protection to 
many business methods, contradicts the clear 
Congressional intent that patents protect “method[s] 
of doing or conducting business.” 35 U.S.C. § 273. 

 
ii 
TABLE OF CONTENTS 
QUESTIONS PRESENTED ....................................... i 
TABLE OF CONTENTS ............................................ ii 
TABLE OF AUTHORITIES ..................................... iv 
INTEREST OF THE AMICUS CURIAE .................. 1 
SUMMARY OF THE ARGUMENT........................... 1 
ARGUMENT .............................................................. 2 
I. The Experience of Amicus Curiae Medtronic, 
Inc., as a Global Leader in Medical Technology 
Innovation Suggests that the Court of Appeals’ 
Revision of Section 101 of the Patent Act to 
Require a Machine or Transformation Will 
Jeopardize Progress Across Diverse Industries. ... 2 
II. Examples of Significant Medical Advances 
that a Machine-Or-Transformation Requirement 
Would Render Patent Ineligible............................. 5 
A. Patient Diagnosis............................................ 7 
B. Monitoring and Medical Data Management.. 9 
C. Personalized Medicine .................................. 11 
III. Section 101 Should Be Inclusive, Rather 
Than Exclusive...................................................... 12 

 
iii 
IV. Section 101 Should Invite the Patenting of 
All Inventions that Result from Human 
Ingenuity and Manipulation. ............................... 15 
V. A Machine-Or-Transformation Requirement 
Would Harm the Public by Deterring Prompt 
and Open Disclosure of Medical Breakthroughs 
and by Discouraging Investment in Medical 
Innovation. ............................................................ 19 
CONCLUSION......................................................... 21 
 

 
iv 
TABLE OF AUTHORITIES 
Cases 
Classen Immunotherapies, Inc. v. Biogen Idec,  
304 Fed. Appx. 866, 2008 WL 5273107  
(Fed. Cir. 2008) (non-precedential) ...................... 15 
Diamond v. Chakrabarty, 447 U.S. 303 (1980)....... 17 
Diamond v. Diehr, 450 U.S. 175 (1981)................... 14 
Gottschalk v. Benson, 409 U.S. 63 (1972).......... 14, 17 
In re Alappat, 33 F.3d 1526 (Fed. Cir. 1994)  
(en banc) ................................................................ 14 
In re Bilski, 545 F.3d 943 (Fed. Cir. 2008)  
(en banc) ............................................................ 3, 17 
In re Comiskey, 499 F.3d 1365 (Fed. Cir. 2007)...... 14 
Lab. Corp. v. Metabolite, 548 U.S. 124 (2006)... 15, 16 
Parker v. Flook, 437 U.S. 584 (1978)....................... 14 
Prometheus Labs., Inc. v. Mayo Collaborative  
Servs., No. 2008-1403 (Fed. Cir. 2009)................. 15 
State St. Bank & Trust Co. v. Signature Fin.  
Group, 149 F.3d 1368 (Fed. Cir. 1998)................. 14 
Statutes 
35 U.S.C. § 101 ..........................................1, 15, 18, 19 

INTEREST OF THE AMICUS CURIAE
With the consent of the parties, this brief is filed by 
Amicus Curiae, Medtronic, Inc., which is a global 
leader in medical technology innovation. Amicus 
Curiae engages in the research and development, 
design, and manufacturing of medical products for 
use in the diagnosis, monitoring, and treatment of 
various diseases. Amicus Curiae’s business 
operations include the medical technologies of 
Cardiac Rhythm Disease Management, Spinal and 
Biologics, CardioVascular, Neuromodulation, 
Diabetes, Surgical Technologies, and Emergency 
Response Systems. Medtronic has no financial 
interest in the outcome of this case. Medtronic seeks 
an application of the patent laws in a manner that 
most effectively promotes innovation and most 
accurately reflects the intent of Congress. 
SUMMARY OF THE ARGUMENT 
The requirement that a process must be tied to a 
particular machine or apparatus, or must transform 
a particular article into a different state or thing to 
be eligible for patenting under 35 U.S.C. § 101 would 
                                                            
1 Pursuant to Supreme Court Rule 37, no counsel for any party 
authored this brief in whole or in part, and no person or entity 
other than Amicus Curiae made a monetary contribution to the 
preparation or submission of the brief. Counsel of record for all 
parties were notified prior to filing and have consented to this 
filing. Letters of consent have been filed with the Clerk of the 
Court. 

 

adversely affect medical technology innovation. The 
machine-or-transformation requirement would 
preclude the patenting of significant advances in 
medical research and development, diagnosis, 
prevention, and treatment. Without the full range of 
incentives of patent exclusivity, medical innovation 
will suffer the loss of investment and a retreat into 
secrecy, the very harms the patent laws were 
enacted to guard against. Moreover, impeding the 
patenting of medical breakthroughs jeopardizes 
public health goals, including affordable universal 
access, by deterring the invention and public 
disclosure of competitive medical technology. The 
machine-or-transformation requirement is therefore 
inappropriate and should be discarded. 
ARGUMENT 
I. The Experience of Amicus Curiae Medtronic, 
Inc., as a Global Leader in Medical Technology 
Innovation Suggests that the Court of Appeals’ 
Revision of Section 101 of the Patent Act to 
Require a Machine or Transformation Will 
Jeopardize Progress Across Diverse Industries. 
Ingenuity has many faces, and innovation takes 
many shapes. These simple truths, however, were 
ignored by the Court of Appeals when it decided the 
case now before this Court by fashioning a broad, 
limiting test with questionable application across 
different technologies. Indeed, this Court’s review of 

 

the Court of Appeals’ judgment in In re Bilski, 545 
F.3d 943 (Fed. Cir. 2008) (en banc), involves the 
significant revision of a patent law standard that has 
far reaching implications beyond the parties or any 
one particular industry. While much public attention 
has focused on the implications for financial services 
and computer software companies, the consequences, 
unintended or otherwise, for medical technology and 
health care have been understated. In this regard, 
Amicus Curiae seeks to better inform the impact of a 
change in patent eligible subject matter that Bilski 
represents. 
The benefits of a robust patent system where Section 
101 of Title 35 of the U.S. Code has earned the 
healthy reputation for inclusion, rather than 
exclusion, are reflected in the story of Amicus 
Curiae. Founded over a half century ago, Amicus 
Curiae began as a medical equipment repair shop. 
The company’s first product, inspired by a musical 
metronome, was nothing short of a life changing 
therapy – a wearable, battery-powered cardiac 
pacemaker. This innovation was the foundation for 
dozens more therapies of Amicus Curiae, which used 
its electrical stimulation expertise to improve the 
lives of millions of people. 
Over the years, Amicus Curiae adapted additional 
technologies for the human body, including radio 
frequency therapies, mechanical devices, drug and 
biologic delivery devices, and diagnostic tools. Today, 

 

the technologies of Amicus Curiae are used to treat 
more than 30 types of chronic diseases affecting 
many areas of the body. Since its humble beginnings 
in Minnesota, Amicus Curiae has grown into a 
multinational company that uses technology to 
transform the way debilitating, chronic diseases are 
treated. 
Amicus Curiae thus implements a diverse group of 
technologies with a focus on the need to provide 
precise clinical interventions as well as progressively 
decentralized health care delivery systems tailored 
to specific patient needs. Specifically, Amicus 
Curiae’s current and future product platforms 
integrate a hybrid of technologies, such as 
electromechanical, electrical, communication 
systems, biotechnology, drugs, and information 
systems, with the objective to identify patient risk 
and deliver appropriate therapy by continuously 
monitoring physiological parameters of a patient or 
indices of a disease state.  
In this highly integrated medical product 
environment, physiological data or health 
information, which generally relate to “natural laws 
or principles” based on correlations, comparisons, 
and deductions, are being used to inform and 
manage therapy delivery and treatment. Amicus 
Curiae invests heavily in the innovative use, 
integration, and implementation of these 
physiological data and relies on the patent system to 

 

advance innovation and deliver on Amicus Curiae’s 
long-standing mission to alleviate pain, restore 
health and extend life. 
Most importantly, the public has been a direct 
beneficiary of the medical advances made possible by 
Amicus Curiae and others because a robust patent 
system has provided the incentive to innovate and 
invest in medical technology. The lives of countless 
patients, as well as those of their families and 
communities, have been touched by medical 
inventions such as rapid diagnostic tests and 
minimally invasive surgical procedures. 
II. Examples of Significant Medical Advances 
that a Machine-Or-Transformation 
Requirement Would Render Patent Ineligible. 
In an attempt to better inform this Court’s 
understanding of the various medical technologies 
that may be affected by upholding the Bilski revision 
to patent eligibility, Amicus Curiae respectfully 
submits a series of examples drawn from composite 
experiences of Amicus Curiae as a global leader in 
medical technology innovation research and 
development on human conditions, disease states, 
and therapies relating to the heart, brain, spine, 
bladder, stomach, blood vessels, and more. These 
illustrations, which include Patient Diagnosis, 
Monitoring and Medical Data Management, and 
Personalized Medicine, reflect the extraordinary 

 

breadth of technology in this industry sector and 
foreshadow the importance of recognizing the grave 
potential consequences, unintended or otherwise, of 
Bilski for medical technology and health care. 
In particular, the examples highlight the problem of 
setting a limiting standard for patent eligibility that 
applies across diverse fields of technology to 
encourage inventors to elect the rights and 
obligations of the patent system. The machine-or-
transformation requirement presents a poor fit for 
those fields that depend on the generation of 
predictive models from a comparison of individual 
sample information against a database of previously 
gathered information. Some have disparaged certain 
methodologies in this regard as the mere correlation 
of natural phenomena. However, while the bare 
observation and act of correlation per se may not be 
patent eligible, precisely how a specific correlation is 
achieved should be. 
In the context of medical technology, the proper 
evaluation and effective treatment of patients 
depend upon complex correlations assessed over 
prescribed times. This, in turn, relies upon the 
generation of predictive models from a comparison of 
an individual patient’s signs and symptoms against 
a database of studied human wellness parameters, 
which contain patterns of diagnosis, chosen 
treatment, and outcome. These efforts are far from 
trivial. 

 

A. Patient Diagnosis 
As applied to medical technology, the Bilski 
machine-or-transformation revision to Section 101 
essentially precludes the patenting of patient 
diagnosis. Under the Bilski test, a method of 
diagnosis unaccompanied by a medical device or 
treatment step would be patent ineligible. However, 
the development of a diagnostic test almost always 
precedes the ability to treat the disease and is often 
a distinct research enterprise separated by years, if 
not decades. 
Indeed, the Patent Office has begun to require 
patent applicants for medical diagnostics inventions, 
who seek to overcome rejections under Section 101 in 
the wake of Bilski, to recite treatment steps. And 
moreover, the Patent Office has been inconsistent in 
administering whether the additional recitation of 
treatment steps will suffice. In any event, this 
misapprehends the nature of medical diagnostics 
development, with the effect being an increasing use 
of Section 101 ineligibility as a dispositive ground for 
denial of patent grant. 
The criticality to the health care system of achieving 
diagnostic correlation for predictive patient modeling 
notwithstanding, this type of correlation is what 
serves as the foundation for further research and 
development. Without the incentive to find such 
correlations due to the absence of patent exclusivity, 

 

many avenues of medical treatment may remain 
underdeveloped or altogether unexplored. 
The patent claims to diagnostic methodologies, 
which have been patentable under Section 101 
because they yield a useful, concrete, and tangible 
result, would fail under the Bilski machine-or-
transformation test. There is no preemption of a 
fundamental principle when a correlation is of 
defined scope, typically associated with a particular 
condition or disease state. For example, imagine a 
method of determining the risk of Sudden Cardiac 
Death (SCD) involving the identification of one or 
more single nucleotide polymorphisms in a patient. 
This insight could enable a health care provider to 
take active measures to successfully prevent or treat 
a life threatening condition before the occurrence of 
any adverse event. 
Consider also the ability to treat children born with 
a pulmonary artery malfunction using a method of 
intelligent scheduling of required multiple surgeries 
as the children grow. This protocol would ensure 
that the necessary sizes and types of implantable 
medical devices are provided at the exact times 
needed to minimize the number of dangerous, 
painful, and sometimes disfiguring procedures. 
But patent claims to such innovations may be 
susceptible to Bilski patent ineligibility although 
they do not preempt a fundamental principle or 

 

equate with an insignificant extra-solution activity. 
To the contrary, these inventions improve the 
quality of health care delivered and patient 
outcomes through earlier diagnosis, less invasive 
treatment options, and reductions in hospital stays 
and rehabilitation times. These important medical 
innovations would be undermined if this Court were 
to uphold the Bilski machine-or-transformation test. 
B. Monitoring and Medical Data Management 
The dependable and accurate relay of patient data is 
an essential component of life saving treatment. 
There are numerous applications for patient data 
management that span the spectrum of chronic to 
acute care. In one instance, a methodology has been 
developed to communicate information of the 
physiological state of a patient who has experienced 
an emergency medical event to a patient treatment 
center to enable the receiving facility to prepare for 
the patient’s arrival. One application of this 
methodology could be routing event data from a field 
device, such as an external defibrillator, to a 
computer server for information distribution 
throughout various hospital displays. 
Another patient data management system transfers 
cardiac information to assist doctors in making a 
decision on whether to bring the patient to a clinic or 
otherwise monitor long term trends, therapy, and 
cardiac events. Specifically, the system is a patient 

 
10 
management tool that builds upon ideas relating to 
continuous monitoring of physiological variances or 
indicators, which are used to monitor a cardiac 
patient remotely and tailor therapy and health care 
as appropriate. Thus, the system is dependent upon 
correlations, extrapolations, and deductions based on 
the detection or monitoring of natural phenomena. 
In most of these types of patient management 
systems, the process of diagnosis, monitoring, or 
even therapy delivery may not be tied to a machine 
or apparatus or transform a particular article into a 
different state or matter. Generally, the major aspect 
of the operation may be comparative, correlative, 
iterative, and deductive, rather than transformative. 
Although certain embodiments of this technology can 
be captured through patent claims that include 
specific device elements (and thus pass muster 
under the Bilski machine-or-transformation test), if 
patent protection to the methodology itself were 
unavailable, the initial concept may not have 
resulted in further development to achieve actual 
application. The business of innovation often 
depends on the initial formulation of a system that 
only later finds integration with real world devices. 
To deny patent eligibility for such methodologies 
would impede this innovation. 

 
11 
C. Personalized Medicine 
The field of personalized medicine and 
pharmacogenomics is rapidly gaining traction in the 
medical technology space. The ability to correlate a 
patient’s genomic profile and gene expression with 
drug adverse event data can enable health care 
providers to maximize the probability of a desired 
treatment outcome and minimize the risk of harmful 
side effects. The recognition and understanding of 
the relationships between certain genetic mutations 
and the occurrence of common diseases to develop 
treatments tailored to an individual patient is the 
exciting potential this medical technology presents. 
However, the labor and cost intensity of these 
correlations are discouraging without the incentive 
of patent exclusivity. 
As an example, the identification of genetic markers 
arguably would suffer inactivity or delay due to 
concerns over collaboration, material transfer, and 
licensing, in the absence of the defined intellectual 
property rights that patents provide. The Bilski 
machine-or-transformation test, if upheld as the sole 
test for patent eligibility under Section 101 as 
espoused by the Court of Appeals, would not easily 
resolve questions about personalized medicine 
inventions where a machine element or 
transformation event seems inapposite. Like the 
jurisprudence relating to the patent law doctrine of 
equivalents, where this Court recognized that the 

 
12 
function-way-result test might be inapplicable to 
certain technologies, the Bilski standard is similarly 
unaccommodating to certain technologies that exist 
today as well as those yet to come. 
III. Section 101 Should Be Inclusive, Rather 
Than Exclusive. 
Section 101 is the principal invitation of the patent 
laws to would-be innovators everywhere to bring 
forward the products of their inventive efforts. Using 
Section 101 in a gate keeping role projects a 
disenfranchising image of a system established, in 
the words of President Abraham Lincoln, to add “the 
fuel of interest to the fire of genius.” Without the 
continued openness of Section 101, this essential 
combustion that drives the engine of innovation may 
become a thing of the past. With public health 
priorities already taking center stage, we cannot 
afford to deny the promise of medical advances that 
have yet to be seen by restricting patent eligible 
subject matter under a machine-or-transformation 
test. 
Unlike the other conditions for patentability set 
forth under the patent statutes, namely novelty and 
nonobviousness, Section 101 of Title 35 governs 
patent eligible subject matter and utility, both of 
which do not require a comparative assessment of 
the claimed invention against the prior art. Without 
such a measure, Section 101 is ill suited to execute a 

 
13 
gate keeper function because it is relatively 
insensitive to the pace of innovation in a specific art. 
Rather, Section 101 looks more holistically to 
progress in the useful arts and best fulfills a role as 
a static prescription, which embraces existing 
technology, and more importantly, encourages the 
ingenuity of technology yet to come. Accordingly, 
attempting to refine Section 101 to strike a 
normative balance today merely defers the debate 
until a new technology of concern arrives. But the 
true detriment of revising the patent eligibility 
standard now would be the incalculable lost 
opportunity from potential innovators discouraged 
from invention and public disclosure. 
Advances in medical technology would not be 
immune from the effect of the machine-or-
transformation requirement set forth in Bilski
Medical technology encompasses numerous products 
and processes, including medical devices and 
supporting software. Indeed, there are many aspects 
of medical technology that would pass muster 
nonetheless under the Bilski revision to patent 
eligibility, but significant other aspects remain that 
would be impeded. And even in those instances 
where a device component or transformation step 
may be incorporated into a patent claim, the 
patentee may still suffer a reduced scope of rights 
due to a greater likelihood of competitive design 
around. 

 
14 
Medical technology can also involve the evaluation, 
diagnosis, and treatment of patients. By way of 
example, a method of patient assessment can relate 
to predictive modeling by comparing the patient’s 
signs and symptoms to a database of other patient 
information to obtain the likelihood of a particular 
condition and/or likely success of certain therapy if 
applied to that patient. This medical treatment, 
whether or not implemented through a general 
purpose computer, yields a “useful, concrete and 
tangible result.” See State St. Bank & Trust Co. v. 
Signature Fin. Group, 149 F.3d 1368, 1373 (Fed. Cir. 
1998) (citing In re Alappat, 33 F.3d 1526, 1544 (Fed. 
Cir. 1994) (en banc)). 
To be certain, such methodologies do not constitute 
“laws of nature, natural phenomena, [or] abstract 
ideas,” see Diamond v. Diehr, 450 U.S. 175, 185 
(1981) (citing Parker v. Flook, 437 U.S. 584, 589 
(1978), and Gottschalk v. Benson, 409 U.S. 63, 67 
(1972)), and thus, in the Court of Appeals’ parlance 
in Bilski, are not fundamental principles. Nor are 
they prohibited mental steps. See Benson, 409 U.S. 
at 67; In re Comiskey, 499 F.3d 1365, 1377 (Fed. Cir. 
2007) (holding that “mental processes,” “processes of 
human thinking,” and “systems that depend for their 
operation on human intelligence alone” are not 
patent-eligible subject matter under Benson). 
However, under the machine-or-transformation 
requirement of Bilski, it is unclear whether the 

 
15 
Patent Office and the federal courts would deny 
patent protection on the grounds of ineligibility 
under 35 U.S.C. § 101. The experiences of Amicus 
Curiae in patent application examinations since 
Bilski suggest the Patent Office has increasingly 
relied on this ground of rejection. 
IV. Section 101 Should Invite the Patenting of 
All Inventions that Result from Human 
Ingenuity and Manipulation. 
As related to medical technology, the confusion 
Bilski creates has resurrected the concern 
contemplated by this Court briefly in Lab. Corp. v. 
Metabolite, 548 U.S. 124 (2006) (“LabCorp”), and has 
manifested in cases such as Classen 
Immunotherapies, Inc. v. Biogen Idec, 304 Fed. Appx. 
866, 2008 WL 5273107 (Fed. Cir. 2008) (non-
precedential), and Prometheus Labs., Inc. v. Mayo 
Collaborative Servs., No. 2008-1403 (Fed. Cir. 2009) 
(reviewing Civil No. 04cv1200 JAH (RBB), 2008 WL 
878910, 86 U.S.P.Q.2d 1705 (S.D. Cal. Mar. 28, 
2008)). Some have criticized patent claims to certain 
medical diagnosis, for example, on the basis that 
they seek patent coverage for the mere correlation of 
natural phenomena. What constitutes mere 
correlation is then a question open to reasonable 
dispute. 
In LabCorp, this Court dismissed the writ of 
certiorari as improvidently granted. Justice Breyer, 

 
16 
joined by Justices Stevens and Souter, dissented 
from the order. The dissent argued that the Court 
should have taken the case in order to lend 
necessary clarity to an important issue in patent 
law. The patent claims at issue in LabCorp recited 
“correlating an elevated level of total homocysteine 
in [a sample of] body fluid with a deficiency of 
cobalamin or folate.” In the dissenters’ view, a 
natural correlation between two substances in the 
body is a “natural phenomenon” that cannot be 
patented. LabCorp, 548 U.S. at 135. 
At least one member of the Court of Appeals has 
recognized the potential havoc that the application of 
the Bilski machine-or-transformation test may 
create with medical technology innovation. In 
dissent from the en banc opinion of the Court of 
Appeals, Judge Rader states: 
Before the invention featured in Lab 
Corp., medical science lacked an 
affordable, reliable, and fast means to 
detect this debilitating condition. 
Denial of patent protection for this 
innovation – precisely because of its 
elegance and simplicity (the chief aims 
of all good science) – would undermine 
and discourage future research for 
diagnostic tools. Put another way, does 
not Patent Law wish to encourage 
researchers to find simple blood tests or 

 
17 
urine tests that predict and diagnose 
breast cancers or immunodeficiency 
diseases? In that context, this court 
might profitably ask whether its 
decisions incentivize research for cures 
and other important technical 
advances. Without such attention, this 
court inadvertently advises investors 
that they should divert their 
unprotectable investments away from 
discovery of “scientific relationships” 
within the body that diagnose breast 
cancer or Lou Gehrig’s disease or 
Parkinson’s or whatever. 
In re Bilski, 545 F.3d 943, 1014 (Fed. Cir. 2008) (en 
banc) (Rader, J., dissenting). Amicus Curiae concurs 
with these policy sentiments. 
Furthermore, while “[p]henomena of nature, though 
just discovered, mental processes, and abstract 
intellectual concepts are . . . the basic tools of 
scientific and technological work,” see Gottschalk v. 
Benson, 409 U.S. 63, 67 (1972)), that does not mean 
all methods, which originate from the invention or 
discovery of a natural correlation, are similarly 
patent ineligible. To hold otherwise would be a 
departure from the wisdom of Diamond v. 
Chakrabarty, 447 U.S. 303, 309 (1980), that 
“anything under the sun that is made by man” is 
patent eligible under 35 U.S.C.§ 101, which 

 
18 
implicitly recognized that human intervention could 
take unpatentable subject matter into the realm of 
patentability. In particular, the mere correlation of 
natural phenomena mantra belies the reality that 
much more often than not, the diagnosis of a patient, 
and the subsequent treatment based on that 
diagnosis, are not the products of mere observation 
and simple correlation. In other words, although a 
correlation step may be at the heart of the claimed 
medical treatment, most procedures involve not only 
the sophisticated appreciation that a correlation may 
exist, but the studied determination to act based on 
a perceived significance of that correlation. But these 
complex methods may not necessarily involve a 
machine or transforming an article into a different 
state or thing. 
In Classen, the Court of Appeals affirmed the district 
court’s summary judgment that Dr. Classen’s patent 
claims were invalid under 35 U.S.C. § 101 because 
the claims were neither tied to a particular machine 
or apparatus, nor did they transform a particular 
article into a different state or thing. The patent 
claim at issue involved a method of determining 
whether an immunization schedule affected the 
incidence or severity of a chronic immune-mediated 
disorder in a treatment group of mammals relative 
to a control group of mammals. The Court of Appeals 
offered no additional reasoning, its opinion being a 

 
19 
mere 69 words, twenty words shorter than the actual 
patent claim. 
In Prometheus, the Court of Appeals is presently 
reviewing the district court’s summary judgment 
that the claims of U.S. Patent No. 6,355,623 are 
invalid under 35 U.S.C. § 101. The patent claim at 
issue involved a method of optimizing therapeutic 
efficacy for treatment of an immune mediated 
gastrointestinal disorder by determining the level of 
6-thioguanine. The district court analysis fell in 
lockstep with this Court’s LabCorp dissent. 
In any event, these cases reflect the tip of the iceberg 
of possible judicial controversy over the patentability 
of medical technology if the Bilski machine-or-
transformation standard is upheld. Moreover, in a 
particularly crowded field of technology, such as 
medical technology, the uncertainty over entitlement 
to patent exclusivity can disqualify otherwise 
innovative methods and their associated products 
from access to commercial investment, market entry, 
and/or post-market entry sustainability. 
V. A Machine-Or-Transformation Requirement 
Would Harm the Public by Deterring Prompt 
and Open Disclosure of Medical 
Breakthroughs and by Discouraging 
Investment in Medical Innovation. 
The oft cited purpose of the patent laws is to promote 
the progress of the useful arts through the creation 

 
20 
of temporary exclusivity rights as an incentive for 
the prompt, public disclosure of inventions because 
the patent exclusivity facilitates innovative efforts 
and encourages investment in such endeavors. These 
principles apply with equal if not greater force in the 
medical technology industry sector, where 
commercial competition is intense. Beyond the 
known beneficial effects today of an enfranchising 
patent eligibility standard under Section 101, 
perhaps a more essential consideration is the 
maintenance of a Section 101 test that will continue 
the promise of patent protection for innovations to 
come. 
The Court of Appeals decision in Bilski opens the 
door to the use of Section 101 as an instrument for 
determining precisely what innovation will be 
acceptable. In Chakrabarty, this Court took the wise 
approach of interpreting Section 101 as broadly 
inclusive in favor of allowing the other statutory 
conditions for patentability to more finely monitor 
what inventions may be patented vis-à-vis the prior 
art. A Section 101 that embraces inclusiveness 
ensures continuing innovation in new as well as old 
fields of technology. Tinkering with Section 101 in 
hopes of crafting a standard generally applicable to 
past, present, and future technologies, however well 
intentioned, may bring unforeseeable consequences, 
including the unfortunate chilling of future 
innovation. 

 
21 
CONCLUSION 
For the foregoing reasons, Amicus Curiae 
respectfully submits that the Bilski machine-or-
transformation test has far reaching consequences 
for enterprises outside the financial services and 
computer software industry sectors that are critical 
to this country’s public health goals and economic 
well being. Indeed, for companies, like Amicus 
Curiae, focused on medical technology innovation, 
the prospect of a revised patent eligibility standard 
that is less inclusive presents the grave concern that 
the development of critical lifesaving medical 
technology will be impeded. 
Respectfully submitted, 
 
 
Lawrence M. Sung 
Michael J. Jaro 
Counsel of Record 
Noreen C. Johnson 
Jeff E. Schwartz 
Girma Wolde-Michael 
Dewey & LeBoeuf LLP 
Medtronic, Inc. 
1101 New York 
710 Medtronic 
  Avenue, NW 
  Parkway, NE 
Washington DC 20005 
Minneapolis MN 55432 
(202) 346-8000
 
 
Counsel for Amicus Curiae 
Medtronic, Inc. 

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