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| [[United States Patent 3,643,513 (HW 2-25) (RCTA)]]
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| [[Historical Development of Nonobviousness (RCTA)]] | | [[Historical Development of Nonobviousness (RCTA)]] |
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| [[Suggestion to Combine (RCTA)]] | | [[Suggestion to Combine (RCTA)]] |
| [[In Re Rouffet]] deals with the issue of a combination of previously-patented elements. The cases above all pre-dated the 1952 statute and the 1966 Supreme Court cases.
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| :"When a rejection depends on a combination of prior art references, there must be some teaching, suggestion, or motivation to combine the references."
| | [[Objective Tests (RCTA)]] |
| :"[T]he suggestion to combine requirement is a safeguard against the use of hindsight combinations to negate patentability. While the skill level is a component of the inquiry for a suggestion to combine, a lofty level of skill alone does not suffice to supply a motivation to combine. Otherwise a high level of ordinary skill in an art field would almost always preclude patentable inventions. As this court has often noted, invention itself is the process of combining prior art in a nonobvious manner.
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| <p> ''KSR International Co. v. Teleflex, Inc.'' also dealt with the issue of combinations. In trying to navigate the murky waters of “ordinary skill in the prior art,” the Court of Appeals for the Federal Circuit (CAFC) established the TSM Test. In this test, the Court looks to the field for a combination of ''teaching, suggesting, or motivating'' to combine old elements into the form under scrutiny for patent approval to determine if the combination was obvious at the time. Ideally, the courts would draw the line of obviousness in such a way that it still furthers the ultimate economic purpose of patents and does not deprive the public of knowledge that it can already access and use. The ''KSR'' Court advocated an “expansive and flexible” approach in discerning whether an invention ought to be considered patentable. Unfortunately, this conflicts with the CAFC and PTO’s understandable desire to establish simple, clear rules and checklists. In order to manage the volume of appeals and patents that they process daily, both organizations are often forced to opt for clear and imperfect guidelines over the ambiguous and carefully considered approach of the Supreme Court. However, in choosing quick decisions over drawn-out deliberation, the CAFC and PTO have sometimes confused “necessary” conditions with “necessary and sufficient” conditions. This could allow many patents to issue which would in fact have been obvious, thereby depriving the public of useful knowledge rather than disclosing to it something new. </p>
| | [[The Inventive Step (RCTA)]] |
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| <p> Ultimately, patent law needs to look beyond the listed patents to really serve its purpose. Hints of obviousness might be found in the listed patents, in the state of technology in general, or from somewhere as far removed from the literature as real-world market demands. The PTO and CAFC have to put themselves in the place of inventor. </p>
| | [[Relationship with Novelty (RCTA)]] |
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| ==Objective Tests (RCTA) ==
| | [[Other Historical Considerations (RCTA)]] |
| Two important considerations were the focus of [[Hybritech v. Monoclonal Antiboties, 802 F.2d 1375]].
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| *A lot of the evidences hinges on laboratory notebooks. The CAFC held that even though the lab notebooks were not witnessed until months or about a year after did not preclude them of being of credible evidentiary value.
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| *The secondary considerations, commercial success, are not optional considerations. If evidence is available pertaining to them, they ''must'' be considered by the court.
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| *This case also considers the concept of ''enablement'' which means that that patent specification must be complete enough so that someone with ordinary skill in the art would be able to make the invention. Enablement is set out in 35 USC 112.
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| ==The Inventive Step (RCTA) ==
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| In a footnote to [[Lyon v. Bausch & Lomb, 224 F.2d 530 (1955)]], the Court notes, “[P]atentability as to this requirement is not to be negatived by the manner in which the invention was made, that is, it is immaterial whether it resulted from long toil and experimentation or from a flash of genius.” Nonobviousness is not limited by the moment of invention. All other things being equal, an invention born of a “eureka moment” is as patentable as one birthed through years of careful experimentation and refinement.
| | [[United States Patent 3,643,513 (HW 2-25) (RCTA)]] |
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| ==Relationship with Novelty (RCTA) ==
| | [[Printed Publication (HW 3-23) (RCTA)]] |
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| Nonobviousness guarantees novelty, but novelty does not guarantee nonobviousness. The ''Hotchkiss'' Court introduced the notion of nonobviousness, and 35 USC 103 codified this idea. Meanwhile, 35 USC 102 describes the manners in which one might lose the right to patent something because the same invention exists elsewhere. 35 USC 102’s novelty criterion is comparatively straightforward. Presentations of documents or product models predating the claimed invention are enough to negate novelty. The PTO and the Court judge things ''as they were'' at the time of invention. Nonobviousness is much more ambiguous because the PTO and the Court must determine how things ''would have been'' at the time prior to the invention without reading the revelations of the patent into the past. That is, if circumstances were such that it would have been trivial to create the invention, then it is obvious. However, if the mix of everything from the literature to market forces to the state of seemingly unrelated fields was such that it would not have been a clear and simple matter to create the invention, then it is nonobvious.
| | [[Doctrine of Equivalents (HW 4-4) (RCTA)]] |
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| ==Nonobviousness vs. Invention (RCTA) ==
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| ==Secondary Considerations (RCTA) ==
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| ==Ordinary Skill in the Art (RCTA) ==
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| | [[Honeywell Ruling (RCTA)]] |
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| [[Reiner v. I. Leon Co. (full text)]] | | [[Quanta Brief Summary 901330223]] |
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| [[Reiner v. I. Leon Co.]]
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| [[South Corp. v. US (full text)]]
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| [[South Corp. v. US]]
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| == Brief of Amici Curiae AMA, ACMG, ASHG, APHMG, and Mayo Clinic in Support of Respondents (Oct. 2, 2009) ==
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| Brief of Amici Curiae American Medical Association, the American College of Medical Genetics, the American Society of Human Genetics, the Association of Professors of Human and Medical Genetics, and Mayo Clinic in Support of Respondents (Oct. 2, 2009)
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| * Interest
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| ** "A basic tenet of medical ethics is that discoveries should and advances in medical care should be shared freely and disseminated openly."
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| ** Join with the government
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| :: Amici join with the government in appealing from the non-medical decision below because the Federal Circuit has more recently used its “machine or transformation” test to approve patents that cover physicians' mental impressions, in ''Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 2009 WL 2950232'' (Fed. Cir. Sept. 16, 2009).
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| * Ruling conflicts with ethical duty and Supreme Court case law
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| * If construed too broadly, Section 101
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| ** Blocks spread of medical knowledge
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| ** Creates unfair monopolies
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| ** Harms patients
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| ** Drives up the cost of healthcare
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| === Argument === | | == Links to Notes == |
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| I. The Federal Circuit's “Machine or Transformation” Test Must Be Applied Properly
| | [[ Brief of Amici Curiae AMA, ACMG, ASHG, APHMG, and Mayo Clinic in Support of Respondents (Oct. 2, 2009) ]] |
| * Instructive, not determinative
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| * Driven instead by more fundamental, historical standards
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| * "it also cannot trump long- applied limits against patent claims that try to pree- mpt the use of fundamental principles"
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| ** Earth and sun
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| ** DNA double helix
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| :: Both processes - which undoubtedly have particular machines and/or transformations that are core to their execution - are unpatentable if they are not limited to some particular application of the principle, because they would cover, and thus “preempt,” every possible implementation that could come from recognizing the fundamental principle. See Gottschalk v. Benson, 409 U.S. 63, 71-72 (1972).
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| II. Public Policy is Well Served by Current Limits on Patentable Subject Matter, Which Preclude Patenting Scientific Data
| | [[Abbott timeline (RCTA)]] |
| * Patents on scientific principles raise ethical concerns for physicians
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| * Patents solely on scientific facts threaten to stifle innovation, including the development of personalized medicine, and to increase health care costs
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| * Patents on scientific principles erode physicians' ability to provide quality patient care
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| ** Thomas Jefferson
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| :: If nature has made any one thing less susceptible than all others of exclusive property, it is the action of the thinking power called an idea, which an individual may exclusively possess as long as he keepsit to himself; but the moment it is divulged, it forces itself into the possession of every one, and the receiver cannot dispossess himself of it.
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| * L. Lessig, The Future of Ideas: The Fate of the Commons in a Connected World 94 (2001)
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| :: Such is the nature of scientific fact; once known, it must be considered. Quality patient care demands that a physician consider test results in light of, among other things, current medical knowledge.
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| Conclusion: Amici support the conclusion of the Federal Circuit, but caution that the “machine or transformation” test not be allowed to override the Court's traditional standards for patentable subject matter.
| | [[Appellate Brief for Petitioner (January 1939) in The Electric Storage Battery Co., Petitioner, v. Genzo Shimadzu and Northeastern Engineering Corporation, Respondents (RCTA)]] |
