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Brief Submitted to Supreme Court in Mayo v. Prometheus Laboratories

Stephen Jenei — Mon, 21 Nov 2011 19:53:22 +0000

In the on-going saga of the patentability of correlations between blood test results and patient health, Prometheus Laboratories submitted its brief to the U.S. Supreme Court. The Court granted cert for the second time in Mayo Collaborative Services v. Prometheus Labs., Inc, Supreme Court No. 10-1150, to consider whether to set limits on when inventors can patent medical diagnostic tests.

An earlier judgment was vacated and the case remanded to the U.S. Court of Appeals for the Federal Circuit for further consideration in light of Bilski v. Kappos, 561. The Federal Circuit, reversing the district court, upheld Prometheus’s patent claims covering a means to measure the level of 6-thioguinine (6-TG) and 6-methylmercaptopurine (6-MMP), which indicates that an adjustment in drug dosage may be required at certain metabolite levels.

The district court decided as a matter of law that the asserted claims were drawn to non-statutory subject matter and as such, unpatentable. However, the Federal Circuit held that methods of treatment claims fall within the realm of patentable subject matter. Prometheus Laboratories, Inc. v. Mayo Collaborative Services (08-1403). The Supreme Court will review that ruling.

The question presented is:

Whether the Federal Circuit correctly held that concrete methods for improving the treatment of patients suffering from autoimmune diseases by using individualized metabolite measurements to inform the calibration of the patient’s dosages of synthetic thiopurines are patentable processes under 35 U.S.C. §101.

Brief Highlights:

“Mayo’s brief distorts the record and ignores the Federal Circuit’s unchallenged construction of the patents-in-suit. Prometheus’s claims are not drawn to scientific facts in the abstract, and they do not “preempt” broad principles like the laws of chemistry or the idea of measuring metabolites. No one can infringe these claims merely by thinking about correlations. The claims describe concrete and specific physical processes, employing synthetic drugs and machines, that are used only to improve the clinical treatment of seriously ill patients.

Mayo argues that the claims’ physical steps should be disregarded because they were old in the art, but that is precisely the discredited “point-of-novelty” approach to 35 U.S.C. §101 that this Court flatly rejected thirty years ago in Diamond v. Diehr, 450 U.S. 175 (1981), and again recently in Bilski v. Kappos, 130 S. Ct. 3218 (2010). This Court has made clear that a process must be evaluated for patent eligibility under §101 as a whole. Novelty and non-obviousness are distinct, fact-intensive questions that are not before this Court. And there certainly is no reason, at the dawn of the 21^st century, for this Court to adopt special rules that would render personalized medicine inventions, or other processes designed to produce useful information, uniquely unpatentable under §101.”

The method claims in the patent at issue typically include two separately lettered steps: (a) administering a drug that provides 6-TG to a subject and (b) determining the levels of the drug’s metabolites, 6-TG and/or 6-MMP, in the subject. The measured metabolite levels are then compared to pre-determined metabolite levels, wherein the measured metabolite levels indicate a need to increase or decrease the level of drug to be administered so as to minimize toxicity and maximize efficacy of treatment.

Mayo, in its brief, continues to play up the harm to patients tactic saying:

Prometheus’s patents, which the district court invalidated but the Federal Circuit upheld, give Prometheus a sweeping monopoly on a biological correlation between drug administration and natural changes in blood chemistry. If these patents are sustained, health care providers, such as Mayo Clinic, cannot improve the numbers Prometheus has assigned to this correlation and provide more accurate drug monitoring services to patients at a lower cost, without permission from Prometheus.

In my mind, this argument is disingenuous. The term “monopoly” is often misused in the context of patent law, but has a better-defined meaning in antitrust laws. A patent does provide the owner a limited monopoly to the claimed invention granted by the government for the term of the patent.

Patents are granted by governments in exchange for making a invention public. Once an invention is made public, others can improve upon it by making further inventions. Thus, patents encourage research and development of ideas and concepts, which can improve our quality of life.

Saying that someone could provide a product or service for lower price but for a patent is just crying “WHAAAAAAA!” over the patent owner exercising legal patent rights. To the extent that Prometheus is engaged in conduct permitted by patent laws, Prometheus cannot be construed as the bad guy.

The question here is whether the patent claims fail under 35 U.S.C. § 101 if it preempts all practical use of an abstract idea, natural phenomenon, or mathematical formula. Mayo is arguing that the Prometheus patents claim a naturally occurring correlation between metabolites of a drug and the toxicity or efficacy of that drug, without specifying any concrete use of this correlation, which would preempt all practical use of the naturally occurring correlation.

Prometheus notes that “[a] patent system that recognizes thiopurine compounds themselves as potentially patentable subject matter, allowing preemption of all uses of these compounds, cannot be concerned that a process patent may preempt some of their uses. ”

Merits Briefs for the Petitioners

Amicus Briefs in Support of the Petitioners

Amicus Briefs in Support of Neither Party

Merits Briefs for the Respondent

Brief for Prometheus Laboratories

Amicus Brief in Support of the Respondent

OK If Employee Transfers Your Inventions Despite Bayh-Dole Act and Lacking Signatory Authority

Stephen Jenei — Mon, 06 Jun 2011 20:24:15 +0000

The U.S. Supreme Court ruled today that Stanford University can’t win its patent infringement case against Roche Molecular Systems because Roche holds an ownership interest in the patents. Board of Trustees of The Leland Stanford Junior University v. Roche Molecular Systems, Inc., et al., Supreme Court of the United States, 563 U. S. ____ (2011).

Question Presented:

“Whether an inventor who is employed by a contractor that elects to retain rights in an invention may defeat the contractor’s right to retain title under the Bayh-Dole Act by contractually assigning his putative rights in the invention to a third party”

Stanford sued Roche and its subsidiaries in 2005, contending that Roche’s HIV test kits infringed Stanford’s patents. Roche responded by asserting that it was a co-owner of the HIV quantification procedure, based on the inventor’s assignment of his rights in a Visitor’s Confidentiality Agreement (VCA) that he signed. Stanford claimed that Holodniy had no rights to assign because the University’s HIV research was federally funded, giving the school superior rights in the invention under the Bayh-Dole Act.

In 1988, Cetus collaborated with scientists at Stanford University’s Department of Infectious Diseases to test the efficacy of new AIDS drugs. Dr. Holodniy joined Stanford and signed an agreement stating that he “agree[d] to assign” to Stanford his “right, title and interest in” inventions resulting from his employment there.

Holodniy’s supervisor arranged for him to conduct research at Cetus to learn about PCR. As a condition of gaining access to Cetus, Holodniy was required to sign an agreement stating that he “will assign and do[es] hereby assign” to Cetus his “right, title and interest in . . . the ideas, inventions, and improvements” made “as a consequence of [his] access” to Cetus. Working with Cetus employees, Holodniy devised a PCR-based procedure for measuring the amount of HIV in a patient’s blood. Upon returning to Stanford, he and other Stanford employees tested the procedure. Stanford secured three patents to the measurement process.

The District Court held that the “VCA effectively assigned any rights that Holodniy had in the patented invention to Cetus,” and thus to Roche. But because of the operation of the Bayh-Dole Act, “Holodniy had no interest to assign.” The court concluded that the Bayh-Dole Act “provides that the individual inventor may obtain title” to a federally funded invention “only after the government and the contracting party have declined to do so.”

The Court of Appeals for the Federal Circuit disagreed. First, the court concluded that Holodniy’s initial agreement with Stanford in the Copyright and Patent Agreement constituted a mere promise to assign rights in the future, unlike Holodniy’s agreement with Cetus in the Visitor’s Confidentiality Agreement, which itself assigned Holodniy’s rights in the invention to Cetus.

Therefore, as a matter of contract law, Cetus obtained Holodniy’s rights in the HIV quantification technique through the VCA. Next, the court explained that the Bayh-Dole Act “does not automatically void ab initio the inventors’ rights in government-funded inventions” and that the “statutory scheme did not automatically void the patent rights that Cetus received from Holodniy.” The court held that “Roche possesse[d] an ownership interest in the patents-in-suit” that was not extinguished by the Bayh-Dole Act, “depriv[ing] Stanford of standing.” The Court of Appeals then remanded the case with instructions to dismiss Stanford’s infringement claim.

A majority of Supreme Court justices affirmed that holding. Justice Roberts, writing for the Supreme Court, said Stanford wasn’t automatically entitled to its researcher’s rights to the invention and the researcher’s agreement with Cetus trumped the contract he had signed with Stanford.

Stanford had based its patent-rights claims on a 1980 federal law that gives schools the ability to retain patent rights on inventions created with federal funding. Stanford argued that universities’ ownership of countless inventions could be threatened if the school loses the case. The current administration and several leading universities filed briefs supporting Stanford’s high-court appeal:

“Here, Holodniy had no patent rights to assign to Cetus because title to the invention vested in Stanford and Stanford exercised its Bayh-Dole rights. The court of appeals decision- which holds that Holodniy’s assignment to Cetus limited the patent rights that Stanford could assert under the Bayh-Dole Act- turns the Act’s framework on its head.” ~Solicitor General

The University and Small Business Patent Procedures Act of 1980 (Bayh-Dole Act) allocates rights in federally funded “subject invention[s]” between the Federal Government and federal contractors. 35 U. S. C. §§201(e), (c), 202(a). The Act defines “subject invention” as “any invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding agreement,” and provides that contractors may “elect to retain title to any subject invention,”

The Bayh-Dole Act provides that contractors may “elect to retain title to any subject invention.” §202(a). To be able to retain title, a contractor must fulfill a number of obligations imposed by the statute. The contractor must “disclose each subject invention to the [relevant] Federal agency within a reasonable time”; it must “make a written election within two years after disclosure” stating that the contractor opts to retain title to the invention; and the contractor must “file a patent application prior to any statutory bar date.” §§202(c)(1)–(3). The “Federal Government may receive title” to a subject invention if a contractor fails to comply with any of these obligations.

The Government has several rights in federally funded subject inventions under the Bayh-Dole Act. The agency that granted the federal funds receives from the contractor “a nonexclusive, nontransferrable, irrevocable, paid-up license to practice . . . [the] subject invention.” §202(c)(4). The agency also possesses “[m]arch-in rights,” which permit the agency to grant a license to a responsible third party under certain circumstances, such as when the contractor fails to take “effective steps to achieve practical application” of the invention. §203. The Act further provides that when the contractor does not elect to retain title to a subject invention, the Government “may consider and after consultation with the contractor grant requests for retention of rights by the inventor.” §202(d).

Some of Stanford’s research related to the HIV measurement technique was funded by the National Institutes of Health (NIH), thereby subjecting the invention to the Bayh-Dole Act. Stanford disclosed the invention, conferred on the Government a nonexclusive, nontransferable, paid-up license to use the patented procedure, and formally notified NIH that it elected to retain title to the invention.

In finding that invention rights go to the inventor, Justice Roberts wrote:

Although much in intellectual property law has changed in the 220 years since the first Patent Act, the basic idea that inventors have the right to patent their inventions has not. Our precedents confirm the general rule that rights in an invention belong to the inventor. It is equally well established that an inventor can assign his rights in an invention to a third party. Thus, although others may acquire an interest in an invention, any such interest—as a general rule— must trace back to the inventor.

In accordance with these principles, we have recognized that unless there is an agreement to the contrary, an employer does not have rights in an invention “which is the original conception of the employee alone.” Such an invention “remains the property of him who conceived it.”. In most circumstances, an inventor must expressly grant his rights in an invention to his employer if the employer is to obtain those rights.

Stanford and the United States as amicus curiae contend that the Bayh-Dole Act reorders the normal priority of rights in an invention when the invention is conceived or first reduced to practice with the support of federal funds. In their view, the Act moves inventors from the front of the line to the back by vesting title to federally funded inventions in the inventor’s employer—the federal contractor. See Brief for Petitioner 26–27; Brief for United States as Amicus Curiae 6.

Roberts then uses linguistic jujitsu to come up with a scenario in which the Bayh-Dole Act only convers the contractor (the university) and somehow not the university employees who inherently must make the invention (unless the invention is made entirely by machine, I guess).

Stanford’s reading of the phrase “invention of the contractor” to mean “all inventions made by the contractor’s employees” is plausible enough in the abstract; it is often the case that whatever an employee produces in the course of his employment belongs to his employer. No one would claim that an autoworker who builds a car while working in a factory owns that car. But, as noted, patent law has always been different: We have rejected the idea that mere employment is sufficient to vest title to an employee’s invention in the employer. Against this background, a contractor’s invention—an “invention of the contractor”— does not automatically include inventions made by the contractor’s employees.

The Bayh-Dole Act’s provision stating that contractors may “elect to retain title” confirms that the Act does not vest title. 35 U. S. C. §202(a) (emphasis added). Stanford reaches the opposite conclusion, but only because it reads “retain” to mean “acquire” and “receive.” That is certainly not the common meaning of “retain.” “[R]etain” means “to hold or continue to hold in possession or use.” Webster’s Third, supra, at 1938; see Webster’s New Collegiate Dictionary 980 (1980) (“to keep in possession or use”); American Heritage Dictionary 1109 (1969) (“[t]o keep or hold in one’s possession”). You cannot retain something unless you already have it. The Bayh-Dole Act does not confer title to federally funded inventions on contractors or authorize contractors to unilaterally take title to those inventions; it simply assures contractors that they may keep title to whatever it is they already have. Such a provision makes sense in a statute specifying the respective rights and responsibilities of federal contractors and the Government.

My guess is that the Supreme Court did not like the proposed scope of the Act if read to its possible extremes:

The Bayh-Dole Act applies to subject inventions “conceived or first actually reduced to practice in the performance of work” “funded in whole or in part by the Federal Government.” 35 U. S. C. §§201(e), 201(b) (emphasis added). Under Stanford’s construction of the Act, title to one of its employee’s inventions could vest in the University even if the invention was conceived before the inventor became a University employee, so long as the invention’s reduction to practice was supported by federal funding. What is more, Stanford’s reading suggests that the school would obtain title to one of its employee’s inventions even if only one dollar of federal funding was applied toward the invention’s conception or reduction to practice.

It is also relevant that the Court really wanted clear agreements in place:

Stanford contends that reading the Bayh-Dole Act as not vesting title to federally funded inventions in federal contractors “fundamentally undermin[es]” the Act’s framework and severely threatens its continued “successful application.” Brief for Petitioner 45. We do not agree. As just noted, universities typically enter into agreements with their employees requiring the assignment to the university of rights in inventions. With an effective assignment, those inventions—if federally funded—become “subject inventions” under the Act, and the statute as a practical matter works pretty much the way Stanford says it should. The only significant difference is that it does so without violence to the basic principle of patent law that inventors own their inventions.

Justice Breyer, joined by Justice Ginsburg, dissented saying that the question presented in this case is whether rights in inventions arising from federally funded research can be terminated unilaterally by an individual inventor through a separate agreement purporting to assign the inventor’s rights to a third party.

In his view, the answer to this question is likely no. But because that answer turns on matters that have not been fully briefed (and are not resolved by the opinion of the Court), he would return this case to the Federal Circuit for further argument.

Congress enacted this statute against a background norm that often, but not always, denies individual inventors patent rights growing out of research for which the public has already paid. This legal norm reflects the fact that patents themselves have both benefits and costs.

The importance of assuring this community “benefit” is reflected in legal rules that may deny or limit the award of patent rights where the public has already paid to produce an invention, lest the public bear the potential costs of patent protection where there is no offsetting need for such protection to elicit that invention. Why should the public have to pay twice for the same invention?

Justice Sotomayor agreed with the opinion but only because Stanford didn’t raise the issues of Breyer and said “I understand the majority opinion to permit consideration of these arguments in a future case.”

Supreme Court Certiorari: Summary Dispositions of Classen and Prometheus

Stephen Jenei — Tue, 29 Jun 2010 16:19:39 +0000

The Supreme Court issued GVR Orders* on two important biotech cases:

Classen Immunotherapies, Inc. v. Biogen IDEC et al. (08-1509)

The petition for a writ of certiorari is granted. The judgment is vacated, and the case is remanded to the United States Court of Appeals for the Federal Circuit for further consideration in light of Bilski v. Kappos, 561 U.S. ___ (2010). This case, a § 101 matter that parallels the issues in Prometheus v. Mayo, involves patents involving a mechanism for evaluating the safety of vaccine administration schedules by comparing or identifying the adverse events associated with various vaccine schedules.

The claims in Classen are directed to methods of selecting vaccine regimens by comparing two regimens and identifying the regimen less likely to cause chronic autoimmune disorders. The patent was killed as directed to patent ineligible processes under Section 101 under the belief that the immunization step was an “insignificant post-solution activity” and the claims were merely an indirect attempt to patent the idea that there is a relationship between vaccine schedules and chronic immune mediated disorders and “an attempt to patent an unpatentable natural phenomenon.”

The Federal Circuit affirmed the district court’s grant of summary judgment that these claims are invalid under 35 U.S.C. § 101 “in light of our decision in In re Bilski.” The held that the claims were neither “tied to a particular machine or apparatus” nor do they “transform[] a particular article into a different state or thing.”

Mayo Collaboratives Svcs., et al. v. Prometheus Laboratories (09-490)

The petition for a writ of certiorari is granted. The judgment is vacated, and the case is remanded to the United States Court of Appeals for the Federal Circuit for further consideration in light of Bilski v. Kappos, 561 U.S. ___ (2010). The Federal Circuit, reversing the district court, upheld Prometheus’s patent claims covering a means to measure the level of 6-thioguinine (6-TG) and 6-methylmercaptopurine (6-MMP), which indicates that an adjustment in drug dosage may be required at certain metabolite levels.

The patent includes only two active steps, “administering” the drug and then “determining” metabolite levels. The claim really just explains the correlation between metabolite levels and therapeutic efficacy and “what the inventors claim to have discovered is that particular concentrations of 6-TG and 6-MMP correlate with therapeutic efficacy and toxicity in patients taking AZA drugs.” The district court decided as a matter of law that the asserted claims were drawn to non-statutory subject matter and as such, unpatentable.

Thankfully, cooler heads appear to have prevailed and the US Court of Appeals for the Federal Circuit has held that methods of treatment claims fall squarely within the realm of patentable subject matter. Prometheus Laboratories, Inc. v. Mayo Collaborative Services (08-1403). The Federal Circuit may now have a chance to take up some issues that were avoided due to the earlier Bilski decision.

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*The Supreme Court of the United States may issue GVR orders (stands for grant, vacate, and remand). These orders are especially appropriate when there has been a change in the law subsequent to the lower court or agency’s decision such as with Bilski. GVR orders are not full explications.

Supreme Court Ponders Hypotheticals In Bilski

Stephen Jenei — Wed, 11 Nov 2009 04:34:40 +0000

The Supreme Court finally heard oral hearings in the Bilski v. Doll case. Here, the Court was asked to consider whether 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.

The Court is also to consider whether the Federal Circuit’s “machine-or-transformation” test contradicts Congressional intent that patents protect “method[s] of doing or conducting business” under 35 U.S.C. § 273. The Supreme Court has not considered what is patentable subject matter since 1981. This case may decide if patents also should protect business processes that do not depend on a particular machine or device.

The en banc Federal Circuit held that Bilski’s claims are not eligible for patenting and set forth a single, “definitive” test for determining whether a process is patent-eligible under § 101: a process is patent-eligible only if “(1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.”

In Bilski, the Federal Circuit seized on a sentence from Diamond v. Diehr, 450 U.S. 175, 184 (1981), quoted from Benson, 409 U.S. at 70, that “[t]ransformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines” (emphasis added).

The majority held that this test was not “optional or merely advisory” but rather “the only applicable test” for patent-eligible processes. In doing so, the Federal Circuit majority overruled its earlier decisions in State Street Bank and AT&T to the extent they relied on a “useful, concrete, and tangible result” as the test for patent eligibility under § 101.

At oral argument, the Supreme Court seemed skeptical about extending patent protection beyond the traditional labors of manufacture. Some questions took an extreme definition:

BREYER: Do you think that the framers would have wanted to require anyone successful in this great, vast, new continent because he thinks of something new to have had to run to Washington and to force any possible competitor to do a search and then stop the wheels of progress unless they get permission? Is that a plausible view of the patent clause?

BREYER: So you are going to answer this question yes. You know, I have a great, wonderful, really original method of teaching antitrust law, and it kept 80 percent of the students awake. They learned things — (Laughter) … It was fabulous. And I could probably have reduced it to a set of steps and other teachers could have followed it. That you are going to say is patentable, too?

Other questions danced around the issue of how inventions can be tied to “technology” — whatever that means:

SOTOMAYOR: So how do we limit it to something that is reasonable? Meaning, if we don’t limit it to inventions or to technology, as some amici have, or to some tie or tether, borrowing the Solicitor General’s phraseology, to the sciences, to the useful arts, then why not patent the method of speed dating?

GINSBURG: Isn’t that the basis on which the patent law rests in Europe, in other countries? They do not permit business method patents. It has to be tied to technology, to science or technology. So if other systems are able to work with the notion of technology-based, why not ours?

Other questions looked at whether there is a real shift in what is patentable or whether certain patentable subject matter just didn’t exist before:

SCALIA: You know, you mention that there are all these — these new areas that didn’t exist in the past because of modern business and what-not, but there are also areas that existed in the past that don’t exist today. Let’s take training horses. Don’t you think that — that some people, horse whisperers or others, had some, you know, some insights into the best 8 way to train horses? And that should have been patentable on your theory.

JAKES: They might have, yes.

SCALIA: Well, why didn’t anybody patent those things?

JAKES: I think our economy was based on industrial process.

SCALIA: It was based on horses, for Pete’s sake. You — I would really have thought somebody would have patented that.

JAKES: There are also issues with enforcement. I can’t really answer why somebody wouldn’t have. There are teaching methods that were patented. There are a number of them that we’ve included in our brief where there were patents issued for teaching methods, and I don’t think that we’ve had a serious enforcement problem with people being sued for using teaching methods. But there have been those 2 people who have sought to patent them rather than keep them as secrets or just use them.

In the end, the justices seemed to be conflicted with wanting to limit patent eligible subject matter to exclude frivilous matters but not wanting to cut out valuable technological advances that happened to be unconnected to a machine or transformation.

SOTOMAYOR: How about if we say something as simple as patent law doesn’t cover business matters instead of what the Federal circuit has begun to say, which is technology is tied to a machine or a transformation of the substance, but I have no idea what the limits of that ruling will impose in the computer world, in the biomedical world, all of the amici who are talking about how it will destroy industries? If we are unsure about that, wouldn’t the safer practice be simply to say it doesn’t involve business methods?

On its face, the Court Justices appear unwilling to allow patent claims for a strategy of hedging risk in buying energy but also reluctant to use this as the definitive case for deciding what should or should not fall within all patentable subject matter. For that, we may have to wait to see if the Court takes up the Prometheus v. Mayo case.

You can see the complete transcript of the oral argument here.

Other reflective commentary is available here:

Patent Docs (The Last Footnote)
PrawfsBlawg (Substance v. Procedure)
WSJ Law Blog (Business-Method Patents on Life Support?)
Feld Thoughts (My Field Trip To The Supreme Court)
IP Watchdog (A Bird’s Eye View)
patents4life (Information, please!)
Patent Prospector (Incoming)

Supreme Court to Look at Whether Process Patent Must Be Tied to Apparatus or Transformation

Stephen Jenei — Thu, 04 Jun 2009 02:41:56 +0000

The U.S. Supreme Court has decided to take up the In re Bilski case. The Court will review a decision in a patent case which questions what things are patentable, including software and business strategies. The applicants have filed a Petition for Writ of Certiorari to the Supreme Court to appeal from the U.S. Court of Appeals for the Federal Circuit in In re Bilski. See Bilski v. Doll (USPTO).

Questions Presented:

Whether 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.”
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.

The Supreme Court has not considered what is patentable subject matter since 1981. This case now raises the most question of what can be patented? Are patents only for manufacturing processes that are tied to a particular machine or produce some physical transformation? Or do patents also embrace modern business processes that do not depend on a particular machine or device?

See the Bilski Petition here.