No. 08-964 
Supreme Court of the United States 
On Writ of Certiorari to the United States Court 
of Appeals for the Federal Circuit 
Jeff Lloyd 
Counsel of Record 
Saliwanchik, Lloyd & Saliwanchik 
A Professional Association 
P.O. Box 142950 
Gainesville, FL 32614-2950 
(352) 375-8100 
 Attorney for Amicus Curiae 
The University of South Florida 

 Table of Contents........................................................i 
Table of Cited Authorities ......................................... ii 
Interest of Amicus Curiae.......................................... 1 
Summary of the Argument ........................................ 3 
Argument.................................................................... 4 
The Federal Circuit’s new test is overly restrictive. ..4 
II.  The Framers of the Constitution intended to promote 
advances in medical diagnosis and treatment. ...................6 
III.  Congress intended advances in medical diagnosis and 
treatment to be patentable subject matter.........................12 
Conclusion ................................................................ 16 

Classen Immunotherapies, Inc. v. Biogen IDEC, 304 
F.App’x 866 (Fed. Cir. 2008) ........................... 2, 4-5 
Classen Immunotherapies, Inc. v. Biogen IDEC, Civil 
No. WDQ-04-2607, 2006 WL 6161856 (D. Md. Aug. 
16, 2006).................................................................. 5 
Diamond v. Chakrabarty, 447 U.S. 303 (1980).. 12-14 
Diamond v. Diehr, 450 U.S. 175 (1981)................... 15 
Gottschalk v. Benson, 409 U.S. 63 (1972).................. 4 
Graham v. John Deere, 383 U.S. 1 (1966).............. 6-7 
In re Bilski, 545 F.3d 943 (Fed. Cir. 2008).......passim 
Parker v. Flook, 437 U.S. 584 (1978)......................... 4 
United States v. Dubilier Condenser Corp., 289 U.S. 
178 (1933)......................................................... 14-15 
35 U.S.C. § 101 (2006).............................................. 13 
35 U.S.C. § 287 (2006).............................................. 14 
Omnibus Consolidated Appropriations Act, 1997, 
Pub. L. No. 104-208, 110 Stat. 3009-67 ............... 14 
U.S. CONST. art. I, § 8, cl. 8........................................ 6 
PHYSIC (New York, L. Nichols 1801).................... 11 
BRITANNICA (1st ed. 1771) ........................... 7, 10-11 
reprinted in 38 HARVARD CLASSICS, pt. 1 (Charles 
W. Eliot ed., P.F. Collier & Son 1910) (1909) ........ 6 
ed., Library of America 1984)............................ 8-10 

The University of South Florida (hereinafter, 
“USF”) is the nation’s ninth largest public university 
and a leading research institution.  Founded in 1956, 
USF has over 46,000 students and more than 13,000 
faculty and staff members, with an annual operating 
budget in excess of $1.8 billion dollars.  USF’s 
mission includes research and scientific discovery for 
the generation, dissemination, and translation of 
new knowledge across disciplines; to strengthen the 
economy; to promote civic culture and the arts; and 
to design and build sustainable, healthy 
communities.  Fueled by its research efforts, USF 
has a substantial economic impact on its region 
estimated at over $3.2 billion dollars annually.   
USF medical researchers strive to expand the 
frontiers of medicine, searching for improved 
methods of diagnosing, prognosing, and treating 
diseases such as cancer, HIV, diabetes, and 
neurological disorders such as Alzheimer’s and 
Parkinson’s diseases.  USF is one of the top 50 
1  In accordance with Supreme Court Rule 37, amicus curiae 
states that this brief was not authored in whole or in part by 
counsel for any party, and that no monetary contribution to the 
preparation or submission of this brief was made by any person 
or entity other than amicus curiae or its counsel.  Counsel of 
record for all parties were timely notified 10 days prior to the 
filing of this brief.  Petitioners have consented to the filing of all 
amicus curiae briefs in support of either or neither party, and 
respondent has consented to the filing of this brief via a 
separate letter of consent dated July 14, 2009.  A copy of this 
letter has been filed with the Clerk of the Court. 

medical schools receiving funding from the National 
Institutes of Health, and USF’s Pediatric 
Epidemiology Center has received over $300 million 
dollars in NIH funding to direct global efforts in 
juvenile diabetes research.  For the 2007/2008 fiscal 
year alone, USF was awarded more than $360 
million dollars in research contracts and grants.  
USF’s hospital partners, Tampa General Hospital 
and the H. Lee Moffitt Cancer Center and Research 
Institute, have been ranked among the nation’s top 
50 hospitals by U.S. News & World Report; and USF 
is classified by the Carnegie Foundation as a top tier 
research university.  
USF has a diverse portfolio of patents and 
pending patent applications across a wide range of 
medical technologies, which through USF’s licensing 
efforts generate additional funding to support 
further research.  The new patent eligibility 
standards adopted by the Court of Appeals for the 
Federal Circuit in In re Bilski, 545 F.3d 943 (Fed. 
Cir. 2008), and as applied by the Federal Circuit in 
Classen Immunotherapies, Inc. v. Biogen IDEC, 304 
F.App’x 866 (Fed. Cir. 2008), if allowed to stand and 
proceed unchecked may have an adverse affect on 
USF’s research programs. 
Amicus curiae therefore submits this brief to 
present argument in support of an affirmative 
response to the first question presented.  Amicus 
curiae presents no argument here on the second 
question presented. 

The Federal Circuit’s “machine-or-
transformation” test is more restrictive than any 
Supreme Court precedent, excluding from patent 
eligibility certain processes that Congress intended 
to be patent eligible.  The test has been applied to 
invalidate issued claims directed to certain medical 
methods. There is no legislative basis for such a 
restriction.  Methods that promote the progress of 
medicine, diagnosis and treatment in particular, 
were clearly contemplated by the Framers of the 
Constitution as well as members of Congress to be 
patent eligible.  Courts should not read into the 
patent laws limitations and conditions which 
Congress has not expressed.  Despite this, the 
Federal Circuit adopted the “machine-or-
transformation” test as the sole test for patent 
eligibility of a process, thereby excluding from patent 
eligibility subject matter that Congress clearly 
considered patent eligible.  This was error.  The first 
question presented should be answered in the 
affirmative, and the Federal Circuit’s error should be 

The Federal Circuit’s new test is overly 
The Federal Circuit’s holding that a process 
claim that “neither recites a particular machine or 
apparatus, nor transforms any article into a 
different state or thing, is not drawn to patent-
eligible subject matter” unnecessarily, unwisely, and 
improperly excludes from patent protection 
technologies that Congress clearly intended to be 
patentable.  In re Bilski, 545 F.3d 943, 961 (Fed. Cir. 
2008).  This “machine-or-transformation” test is 
useful as a starting point for determining whether 
process claims are directed to patent eligible subject 
matter.  This Court has held that the “machine-or-
transformation” test is sufficient to qualify a process 
claim as patent eligible, but the Court has declined 
to state that passing this test is a necessary 
requirement for the patent eligibility of a process 
claim.  See  Parker v. Flook, 437 U.S. 584, 588 n.9 
(1978); Gottschalk v. Benson, 409 U.S. 63, 71 (1972).  
Excluding from patent eligibility certain processes 
involving medical diagnosis and treatment merely 
because they do not recite a particular machine or 
apparatus or transform an article into a different 
state or thing is improper, as such processes are 
unquestionably within the realm of patent eligible 
subject matter.  Yet this is exactly what the Federal 
Circuit’s “machine-or-transformation” test has done.   
The Federal Circuit first applied its new 
“machine-or-transformation” test in a single-
paragraph, nonprecedential opinion in Classen 

Immunotherapies, Inc. v. Biogen IDEC, affirming a 
district court judgment invalidating claims to 
methods of immunizing a mammalian subject.2  304 
F.App’x 866 (Fed. Cir. Dec. 19, 2008), reh’g denied en 
banc reh’g denied (Feb. 9, 2009).  While the claims at 
issue might well have been found invalid on other 
grounds (for example, as obvious or anticipated), as 
discussed below, they are certainly within the realm 
of subject matter contemplated as patent eligible by 
the Framers of the Constitution and Congress.  Thus, 
applying the “machine-or-transformation” test as the 
2 The district court had summarized the Classen claims as 
requiring “1) comparing the incidence of immune mediated 
disorders in treatment groups with different vaccination 
schedules; and 2) immunizing patients on a schedule identified 
as low risk.”  Classen Immunotherapies, Inc. v. Biogen IDEC
Civil No. WDQ-04-2607, 2006 WL 6161856, at *5 (D. Md. Aug. 
16, 2006).  Rather than properly construing the claims as “a 
method for reducing the incidence of chronic immune mediated 
disorders” and recognizing that an improved process of 
vaccination is a human invention, the district court held that 
the claims describe a natural correlation.  Id.  Characterizing 
the correlation between vaccination schedules and incidents of 
immune mediated disorders as a natural phenomenon, the 
court held the claims invalid as an attempt to patent a natural 
phenomenon.  Id.  The district court’s reasoning was faulty: the 
existence of an immune response in mammals is a natural 
phenomenon.  Human experimentation, manipulation, and 
optimization of the immune response to achieve beneficial 
results is not a natural phenomenon.  On appeal, the Federal 
Circuit did not discuss whether the claims describe a natural 
phenomenon.  Instead, the panel applied the new test without 
analysis, declaring “Dr. Classen’s claims are neither ‘tied to a 
particular machine or apparatus’ nor do they ‘transform[ ] a 
particular article into a different state or thing.’  Therefore we 
affirm.”  Classen, 304 F.App’x at 867 (quoting In re Bilski, 545 
F.3d. at 954) (alteration in original).   

only test for patent eligibility is clearly improper. 
The Framers of the Constitution 
intended to promote advances in medical 
diagnosis and treatment.   
The Constitution grants Congress broad power 
to legislate to “promote the Progress of Science and 
useful Arts, by securing for limited Times to . . . 
Inventors the exclusive Right to their . . . 
Discoveries.”  U.S.  CONST. art. I, § 8, cl. 8.  At the 
time the Constitution was drafted, medicine had for 
more than two thousand years been known as one of 
the “useful Arts.”  The Oath of Hippocrates refers to 
medicine as “the art,” “this art,” or “my art” on five 
1 (Charles W. Eliot ed., P.F. Collier & Son 1910) 
(1909).  The first sentence of The Law of Hippocrates 
states “Medicine is of all the Arts the most noble; but 
owing to the ignorance of the ones who practice 
it,  . . . it is at present far behind all the other arts.”  
Id.  In the late 18th century, those who were 
educated in classical learning included Thomas 
Jefferson, and they were well aware that medicine 
was one of the “useful Arts.” 
In  Graham v. John Deere, this Court discussed 
the legislative history of patent law at length, 
including analysis of the influence of Thomas 
Jefferson on the development of our patent system, 
noting “[b]ecause of his active interest and influence 
in the early development of the patent system, 
Jefferson’s views on the general nature of the limited 
patent monopoly under the Constitution, as well as 

his conclusions as to conditions for patentability 
under the statutory scheme, are worthy of note.”  
383 U.S. 1, 7 (1966).  As illustrated below, 
Jefferson’s writings and other writings of his time 
indicate that medicine, including methods of 
treatment and diagnosis, would have been included 
in the Framers’ definition of “useful Arts.” 
In Jefferson’s time and in Jefferson’s mind, 
medicine was clearly understood to be one of the 
“useful Arts.”  The first edition of the Encyclopædia 
Britannica states: 
Medicine is generally defined to be, The art 
of preserving health when present and of 
restoring it when lost . . . .  Most arts require 
the experience of ages before they can arrive 
at a high degree of perfection.  Medicine is 
unquestionably one of the most ancient; and 
consequently, the improvement of it might be 
expected to bear some proportion to its 
antiquity but, whilst philosophy, in all its 
branches, has been cultivated and improved 
to a great extent; medicine, not withstanding 
the collateral advantages it has of late 
derived from anatomy and other sciences 
still continues to be buried in rubbish and 
BRITANNICA 58 (1st ed. 1771) [hereinafter 
ENCYCLOPÆDIA BRITANNICA] (emphasis added).   
Jefferson’s letters make clear that he considered 
medicine to be one of the “useful Arts” in need of 

advancement through both observation and 
innovation.  For example, in his letter on “Freedom 
of Mind” to William Green Munford dated June 18, 
1799, Jefferson states: 
Surgery is well advanced; but prodigiously 
short of what may be.  The state of medecine 
[sic] is worse than that of total ignorance . . . .  
We have a few medecines, as the bark, opium, 
mercury, which in a few well defined 
diseases are of unquestionable virtue: but 
the residuary list of the materia medica, long 
as it is, contains but the charlataneries of 
the art; and of the diseases of doubtful form, 
physicians have ever had a false knowledge, 
worse than ignorance.  Yet surely the list of 
unequivocal diseases & remedies is capable 
of enlargement; and it is still more certain 
that in the other branches of science, great 
fields are yet to be explored to which our 
faculties are equal, & that to an extent of 
which we cannot fix the limits.  I join you 
therefore in branding as cowardly the idea 
that the human mind is incapable of further 
Peterson ed., Library of America 1984) (emphasis 
added).  Similar evidence is found in Jefferson’s 
letter entitled “Unlearned Views of Medicine” to Dr. 
Caspar, dated June 21, 1807.  In this letter, 
Jefferson provides his opinions on the state of 
medicine and medical education:  
. . . [F]ulness of the stomach we can relieve 

by emetics; diseases of the bowels, by 
purgatives; inflammatory cases, by bleeding; 
intermittents [fevers], by the Peruvian bark; 
syphilis, by mercury; watchfulness, by 
opium; etc.  So far, I bow to the utility of 
medicine.  It goes to the well-defined forms 
of disease, & happily, to those the most 
frequent.  But the disorders of the animal 
body . . . are as various as the elements of 
which the body is composed . . . .  To an 
unknown disease, there cannot be a known 
remedy.  Here then, the judicious, the moral, 
the humane physician should stop . . . .  But 
the adventurous physician goes on, & 
substitutes presumption for knolege [sic] . . . .  
It is in this part of medicine that I wish to 
see a reform, an abandonment of hypothesis 
for sober facts, the first degree of value set 
on clinical observation, and the lowest on 
visionary theories . . . .  I would wish the 
young practitioner . . . to have deeply 
impressed on his mind, the real limits of his 
Id.  at 1181-1185 (emphasis added).  Yet another 
example can be found in Jefferson’s letter “The 
Value of Classical Learning” to John Brazier dated 
August 24, 1819.  Jefferson advocated studying the 
Classics in their original Greek and Latin and was 
thoroughly familiar with the writings of Hippocrates.  
In discussing the benefits of classical learning and in 
particular its utility to various members of society, 
Jefferson notes that the Greek and Roman texts 
have given to physicians: 

as good a code of his art as has been given 
us to this day.  Theories and systems of 
medicine, indeed, have been in perpetual 
change from the days of the good 
Hippocrates to the days of the good Rush, 
but which of them is the true one?  The 
present,  to  be  sure,  as  long  as  it  is  the 
present, but to yield its place in turn to the 
next novelty, which is then to become the 
true system, and is to mark the vast advance 
of medicine since the days of Hippocrates.  
Our situation is certainly benefited by 
the discovery of some new and very valuable 
medicines; and substituting those for some of 
his with the treasure of facts, and of sound 
observations recorded by him (mixed to be 
sure with anilities of his day) and we shall 
have nearly the present sum of the healing 
Id.  at 1424 (emphasis added).  Thus, substantial 
evidence exists that Jefferson and others of his time 
considered the term “useful Arts” to encompass 
medicine.  Moreover, these letters indicate that 
Jefferson considered medicine, including medical 
diagnosis and treatment, to be a field in which great 
progress was both possible and needed for the 
benefit of society. 
The 1771 edition of Encyclopædia Britannica 
again echoes Jefferson’s sentiments regarding the 
need for progress in the “art” of medicine: 
In every art which is not founded on known 
facts and established principles, new projects 

are eagerly grasped at; and though they lead 
to error and false reasoning, it is long before 
the professors of that art can be induced to 
give over the pursuit.  This observation is 
particularly applicable to medicine.  The 
theories of diseases, as well as the mode of 
prescription, are as variable as the fashion of 
a lady’s headdress.  No other argument is 
necessary to shew the crude state of the art 
and the boundless field for improvement. 
3 ENCYCLOPÆDIA BRITANNICA, supra, at 60 (emphasis 
Finally, one of the foremost medical experts of 
the 18th Century, Dr. William Cullen wrote in the 
first lines of the introduction of his two-volume 
treatise First Lines of the Practice of Physic
1.]  In teaching the Practice of Physic, we 
endeavor to give instruction for discerning
distinguishing,  preventing, and curing 
diseases, as they occur in particular persons. 
2.]  The art of DISCERNING and 
DISTINGUISHING diseases . . . . 
PHYSIC 25 (New York, L. Nichols 1801) (Introduction 
written in 1789) (second emphasis added).  Thus, 
authorities in the field of medicine also viewed 
various aspects of the field as an “art.” 
From the foregoing it is clear that the field of 
medicine was considered by the Framers to be one of 

the “useful Arts.”  It is also clear that procedures for 
diagnosis and treatment of diseases were considered 
arts within the more general art of medicine.  
Moreover, Jefferson and his contemporaries 
repeatedly voiced an acute need for progress in the 
art of medicine.  The Constitution was thus drafted 
with an understanding of medicine as a “useful Art” 
in which “progress” was greatly desired. 
III.  Congress intended advances in medical 
diagnosis and treatment to be patent 
eligible subject matter.   
From the first Patent Act, Congress has broadly 
described the class of inventions eligible to be 
considered for Patents.  Later acts of Congress made 
clear that medicine, including methods of diagnosis 
and treatment, were meant to be included in that 
description.  As further discussed below, reading the 
Patent Act in a manner which excludes methods of 
diagnosis and treatment from the class of patent 
eligible inventions is contrary to the legislative 
history as interpreted by this Court. 
This Court has repeatedly recognized that the 
legislative history of the Patent Act supports a broad 
construction of patent eligible subject matter.  In 
Diamond v. Chakrabarty, this Court noted that: 
The Patent Act of 1793, authored by Thomas 
Jefferson, defined statutory subject matter 
as “any new and useful art, machine, 
manufacture, or composition of matter, or 
any new or useful improvement [thereof].”  
Act of Feb. 21, 1793, § 1, 1 Stat. 319.  The 

Act embodied Jefferson's philosophy that 
“ingenuity should receive a liberal 
encouragement.”  5 Writings of Thomas 
Jefferson 75-76 (Washington ed. 1871).  See 
Graham v. John Deere Co., 383 U.S. 1, 7-10, 
86 S.Ct. 684, 688-690, 15 L.Ed.2d 545 (1966).  
Subsequent patent statutes in 1836, 1870, 
and 1874 employed this same broad 
language.  In 1952, when the patent laws 
were recodified, Congress replaced the word 
“art” with “process,” but otherwise left 
Jefferson's language intact.  The Committee 
Reports accompanying the 1952 Act inform 
us that Congress intended statutory subject 
matter to “include anything under the sun 
that is made by man.”  S.Rep.No.1979, 82d 
Cong., 2d Sess., 5 (1952); H.R.Rep.No.1923, 
82d Cong., 2d Sess., 6 (1952). 
447 U.S. 303, 308-309 (1980).  Though Congress 
replaced the word “art” with “process,” in the 1952 
act, the act also defined “process” as “a process, art, 
or method.”  35 U.S.C. § 101(b) (2006).  Thus, the 
term “process” was defined as including that which it 
replaced.  Accordingly, “any new and useful art . . . 
or any new or useful improvement [thereof]” which 
was patent eligible before enactment of the 1952 
Patent Act remained patent eligible subject matter 
under the 1952 act.   
In  Chakrabarty, this Court went on to discuss 
the reasons behind a broad construction of the 
patent eligible subject matter provisions of the 
Patent Act.  The Court recognized that “[t]he subject 

matter provisions of the patent law have been cast in 
broad terms to fulfill the constitutional and 
statutory goal of promoting ‘the Progress of Science 
and the useful Arts’ with all that means for the 
social and economic benefits envisioned by 
Jefferson.”  Chakrabarty,  447 U.S. at 315.  As 
discussed above, advances in medicine, particularly 
methods of diagnosis and treatment, were social 
benefits that Jefferson hoped for and envisioned.   
The current act provides further evidence that 
Congress intended processes of diagnosis and 
treatment to be patent eligible subject matter.  In 
1996, the act was amended to explicitly exclude 
medical practitioners from liability for infringing a 
patent by the performance of a medical or surgical 
procedure on a body (including a human body, organ, 
or cadaver, or a non-human animal).  Omnibus 
Consolidated Appropriations Act, 1997, Pub. L. No. 
104-208, 110 Stat. 3009-67 (codified as amended at 
35 U.S.C. § 287(c) (2006)).  Significantly, § 287 
excludes from its application the practice of patented 
biotechnology processes and certain pharmacy and 
clinical laboratory services, for which medical 
practitioners remain liable for patent infringement.  
35 U.S.C. § 287(c) (2006).  The fact that Congress felt 
the need to create such exclusions makes clear that 
they intended new and useful medical processes such 
as methods of diagnosis or treatment to be patent 
eligible subject matter. 
In  United States v. Dubilier Condenser Corp., 
this Court cautioned: “We should not read into the 
patent laws limitations and conditions which the 

Legislature has not expressed.”  289 U.S. 178, 199 
(1933).  The Federal Circuit’s “machine-or-
transformation” test as set forth in In re Bilski is 
more restrictive than required by this Court’s 
precedent and finds no support in any legislation.  In 
practice, it has already been applied to strike down 
patents directed to methods of immunizing patients 
with improved efficacy and safety thereby casting a 
cloud on the validity of a great many process patents 
in the medical and biotechnological fields. 
The “machine-or-transformation” test is a useful 
starting point for analysis of patent eligibility of 
process claims.  However, if a process claim is not 
tied to a particular machine or does not recite 
transformation of an article into a different state or 
thing, the inquiry should not stop there, as the 
process may still be patent eligible as long as it does 
not attempt to claim “laws of nature, natural 
phenomena, [or] abstract ideas.”  Diamond v. Diehr
450 U.S. 175, 185 (1981).  The inquiry should 
carefully analyze whether the claimed process is 
truly claiming a phenomenon of nature, ever mindful 
of the difference between phenomena that are 
entirely products of nature and inventions that are 
the result of how nature reacts to the purposeful 
activity of man.  Where the activities of man cause a 
useful, tangible, concrete result that did not exist 
before, the process should be considered patent 

The Federal Circuit’s holding that a “process” 
must be tied to a particular machine or apparatus, or 
transform a particular article into a different state 
or thing, to be patent eligible is too restrictive.  The 
holding excludes subject matter that Congress 
clearly intended to be patent eligible.  Therefore, 
amicus curiae respectfully requests that the Court 
reverse the decision of the Federal Circuit and 
answer the first question presented in the 
Respectfully submitted, 
Jeff Lloyd 
Counsel of Record 
Saliwanchik, Lloyd & Saliwanchik 
A Professional Association 
P.O. Box 142950 
Gainesville, FL 32614-2950 
(352) 375-8100 
Attorney for Amicus Curiae 
The University of South Florida