The document discusses the implications of the Federal Circuit's decision in Ariad v. Eli Lilly, which reaffirmed that 35 U.S.C. 112 contains both a written description requirement and an enablement requirement. The decision clarifies that the written description requirement mandates that the inventor demonstrate possession of the full scope of the claimed invention by sufficiently describing it within the specification. For broad claims encompassing genera, the specification must describe a sufficient variety of species to evidence possession.
Hyperloop new transportation system seminar presentation - Aishwarya karhadeAishwarya Karhade
Hyperloop is the most ambitious project in the whole world. Every engineering student must learn about it.its all about hyperloop a-z information, a basic working principle to expert views, detailed literature survey with references. I have studied detailed for 3rd-year academic seminars and prepared presentations and detailed reports.
Underground cables are used for power applications where it is impractical, difficult, or dangerous to use the overhead lines. They are widely used in densely populated urban areas, in factories, and even to supply power from the overhead posts to the consumer premises.
The underground cables have several advantages over the overhead lines; they have smaller voltage drops, low chances of developing faults and have low maintenance costs. However, they are more expensive to manufacture, and their cost may vary depending on the construction as well as the voltage rating.
The underground cables are classified in two ways; by the voltage capacity, or by the construction.
By Voltage
LT cables: Low-tension cables with a maximum capacity of 1000 V
HT Cables: High-tension cables with a maximum of 11KV
ST cables: Super-tension cables with a rating of between 22 KV and 33 KV
EHT cables: Extra high-tension cables with a rating of between 33 KV and 66 KV
Extra super voltage cables: with maximum voltage ratings beyond 132 KV
By Construction
Belted cables: Maximum voltage of 11KVA
Screened cables: Maximum voltage of 66 KVA
Pressure cables: the Maximum voltage of more than 66KVA
Hyperloop new transportation system seminar presentation - Aishwarya karhadeAishwarya Karhade
Hyperloop is the most ambitious project in the whole world. Every engineering student must learn about it.its all about hyperloop a-z information, a basic working principle to expert views, detailed literature survey with references. I have studied detailed for 3rd-year academic seminars and prepared presentations and detailed reports.
Underground cables are used for power applications where it is impractical, difficult, or dangerous to use the overhead lines. They are widely used in densely populated urban areas, in factories, and even to supply power from the overhead posts to the consumer premises.
The underground cables have several advantages over the overhead lines; they have smaller voltage drops, low chances of developing faults and have low maintenance costs. However, they are more expensive to manufacture, and their cost may vary depending on the construction as well as the voltage rating.
The underground cables are classified in two ways; by the voltage capacity, or by the construction.
By Voltage
LT cables: Low-tension cables with a maximum capacity of 1000 V
HT Cables: High-tension cables with a maximum of 11KV
ST cables: Super-tension cables with a rating of between 22 KV and 33 KV
EHT cables: Extra high-tension cables with a rating of between 33 KV and 66 KV
Extra super voltage cables: with maximum voltage ratings beyond 132 KV
By Construction
Belted cables: Maximum voltage of 11KVA
Screened cables: Maximum voltage of 66 KVA
Pressure cables: the Maximum voltage of more than 66KVA
Air brake system in indian railways.pptmshristi singh
Why vacuum brake system is replaced by air brake system in Railways and their working ,function of air brake components and the difference between the vacuum brake and air brake system.
This continuing legal education (CLE) presentation covers new developments in patent law. In particular, the presentation provides an overview of 35 USC § 112, first paragraph, written description and enablement case law and describes how functional claim language in patents is treated by that case law. In addition, the presentation focuses on how the Federal Circuit treated functional claim language in a recent en banc case, Ariad v Lilly (Fed. Cir. 2010) and how the Board of Patent Appeals and Interferences has recently treated functional claim language in a series of recent cases citing to the precedential case, Ex Parte Miyazaki (BPAI 2008).
Biotechnology Patents: Disclosure Requirements under 35 USC 112. Discusses case law development of the enablement and written description requirements from In re Wright (Fed. Cir. 1993) through Ariad Pharmaceuticals v. Eli Lilly (Fed. Cir. 2010), including the origin of the "super enablement" requirement in Regents of the University of California v. Eli Lilly (Fed. Cir. 1997), the thought provoking dissent by Chief Judge Rader in Enzo Biochem v. Gen-Probe (Fed. Cir. 2002), the paradoxical "nascent technology" holding in Chiron v. Genentech (Fed. Cir. 2004), and the risks of relying on functional claim language from Rochester v. Searle (Fed. Cir. 2004). Practice tips are provided for avoiding the pitfalls in patent and claim drafting in view of these seminal cases.
This presentation discusses the patent application disclosure requirements under 35 U.S.C. Section 112 and relates, in particular, to the Supreme Court and Federal Circuit case law relevant to patent specifications and claims protecting inventions in the life sciences, biotechnology, and pharmaceutical industries
Life science patents have grown increasingly vulnerable to rejection and invalidation due to subject matter eligibility and enablement interpretations. The implications are staggering with over 80% of abandoned life science applications having a final rejection stating that the innovation did not include patentable subject matter. In this talk, we’ll explore how to avoid these rejections, understand the implications for new drugs, and provide practical tips for creating robust life science patents.
Air brake system in indian railways.pptmshristi singh
Why vacuum brake system is replaced by air brake system in Railways and their working ,function of air brake components and the difference between the vacuum brake and air brake system.
This continuing legal education (CLE) presentation covers new developments in patent law. In particular, the presentation provides an overview of 35 USC § 112, first paragraph, written description and enablement case law and describes how functional claim language in patents is treated by that case law. In addition, the presentation focuses on how the Federal Circuit treated functional claim language in a recent en banc case, Ariad v Lilly (Fed. Cir. 2010) and how the Board of Patent Appeals and Interferences has recently treated functional claim language in a series of recent cases citing to the precedential case, Ex Parte Miyazaki (BPAI 2008).
Biotechnology Patents: Disclosure Requirements under 35 USC 112. Discusses case law development of the enablement and written description requirements from In re Wright (Fed. Cir. 1993) through Ariad Pharmaceuticals v. Eli Lilly (Fed. Cir. 2010), including the origin of the "super enablement" requirement in Regents of the University of California v. Eli Lilly (Fed. Cir. 1997), the thought provoking dissent by Chief Judge Rader in Enzo Biochem v. Gen-Probe (Fed. Cir. 2002), the paradoxical "nascent technology" holding in Chiron v. Genentech (Fed. Cir. 2004), and the risks of relying on functional claim language from Rochester v. Searle (Fed. Cir. 2004). Practice tips are provided for avoiding the pitfalls in patent and claim drafting in view of these seminal cases.
This presentation discusses the patent application disclosure requirements under 35 U.S.C. Section 112 and relates, in particular, to the Supreme Court and Federal Circuit case law relevant to patent specifications and claims protecting inventions in the life sciences, biotechnology, and pharmaceutical industries
Life science patents have grown increasingly vulnerable to rejection and invalidation due to subject matter eligibility and enablement interpretations. The implications are staggering with over 80% of abandoned life science applications having a final rejection stating that the innovation did not include patentable subject matter. In this talk, we’ll explore how to avoid these rejections, understand the implications for new drugs, and provide practical tips for creating robust life science patents.
On November 30, 2010, Woodard, Emhardt attorney John Bradshaw was a featured speaker in a webinar entitled “Summary of Pitfalls and Strategies to Avoid Charges of Inequitable Conduct.” The webinar was part of the Practical Tips for Young Lawyers series sponsored by the Intellectual Property Section of the American Bar Association. Mr. Bradshaw's presentation focused on the development of the doctrine of inequitable conduct and included a summary of specific circumstances where inequitable conduct has been found. Predictions on where the doctrine may be heading and current best practices for patent prosecutors was also discussed.
Pitfalls and Strategies to Avoid Charges of Inequitable Conduct
Ariad and Written Description
1. The Implications of the Federal Circuit Reaffirming the Written Description Doctrine in the Ariad v. Eli Lilly Decision Paul M. Rivard John P. Iwanicki May 6, 2010
This single paragraph of the statute – actually a single sentence – contains three separate requirements: written description, enablement, and best mode. The way the paragraph is structured, it’s easy to see that best mode is a separate requirement (“shall contain . . . and shall set forth the best mode”). But what is less clear is whether written description and enablement are separate requirements or aspects of a single requirement.
When we get to the parties’ arguments in Ariad, we’ll see how they argued different ways the statute should be read. As the case law developed at the Federal Circuit, the court held that written description was a separate requirement from enablement. Ariad involved this question going before the en banc court, which reaffirmed the existing law.
Vas-Cath (1991) involved a catheter for removing blood from arteries, with joined semi-circular lumens (tubes) that come to a single tapered tip. The design reduced the puncture area significantly relative to prior coaxial configurations, making injury to blood less likely. Mahurkar had an earlier filed design application that contained the same drawings.
Vas-Cath really involved two main questions: (1) can drawings alone provide a written description, and (2) is there a written description requirement separate from the enablement requirement? There was no dispute that the design drawings were enabling. The patentee argued Section 112 first paragraph was therefore satisfied. Vas-Cath argued that the design application didn’t provide a “written description” of the invention, and the district court agreed. Without the priority date, a published Canadian design was prior art. The Federal Circuit disagreed, holding that a drawing alone may be a sufficient written description. A picture says a thousand words. The court also squarely addressed the issue of whether 112 has a separate written description requirement.
Fiers was one of the early biotech cases on written description. As we see from this quote, written description is intertwined with conception: for chemical compounds (inc. DNA) need structural features not just function. Conception is defined as a definite and permanent idea of the complete and operative invention, as it is thereafter to be applied in practice. In Fiers, the court said the specification gave no more than a “wish” or “plan” for obtaining the claimed DNA.
In University of California v Eli Lilly (1997), at issue was whether the patents’ example of rat insulin cDNA (complementary DNA) was an adequate written description for claims directed to human cDNA. Describing the human DNA only functionally with a general method of how to make it, was not enough.
In the Univ. of Rochester case in 2004, the question of a separate written description requirement again was before the court. The patent claimed methods of selectively inhibiting the COX-II enzyme for treating inflammation. Although the patent didn’t claim the active compound itself, a selective COX-II inhibitor was necessary to the practice of the method.
Four judges dissenting from the denial of rehearing en banc – so this same question almost went to the en banc court back in 2004. As an aside, this case also involved perhaps the greatest conflict of interest in the history of patent law. The now-defunct Pennie & Edmonds had attorneys representing Pfizer while attorneys literally down the hall procured this patent for the U of R specifically targeting Pfizer’s Celebrex product. I believe the terms of the settlement were undisclosed, but it contributed to the demise of the firm.
So out of these cases comes the “possession” test, which has turned out to be a fuzzy concept. For those who might not recognize this photograph, it is David Tyree’s famous reception in Super Bowl XLII where he somehow trapped the football against is helmet as he was tackled to the ground. Also, we all know that possession is an important legal concept since it’s nine-tenths of the law.
Enzo involved biological deposits. The patentee argued the deposit showed possession of the invention, in quite a literal sense. Possession is “ancillary” to having written description but not the end-all. The court said ‘possession’ is “especially meaningful” when examining whether claims are entitled to priority application, whether interference count is supported, or whether new claims are supported. The first time this case was at the Federal Circuit (Enzo I) the panel held that actual possession by the inventors (via deposit) was not sufficient to cure a lack of written description in the specification, and the claims were invalid. On rehearing, the court reversed itself.
The patent was based on an important discovery – the inventors’ identification of a particular protein and its relationship to how the body develops immune responses to infection.
Kappa B inhibitors The classes of molecules were only identified in a very general sense.
Basically, if there was only a single requirement you wouldn’t need to break the statute into having a description “of invention” and “of the manner and process of making and using.”
Since 112 first paragraph didn’t significantly change after claims requirement was introduced (now second paragraph), it became unclear whether there remained any purpose of written description other than enablement.
Schriber-Schroth - The Court found that the even if the specification was enabling for a flexible web, it “was not the invention which [the patentee] described by his reference to an extremely rigid web.” Morse – claim 8 covered every conceivable way of printing characters at a distance using electric or galvanic current. Morse did not “describe” and “had not invented” what was claimed. Festo (probably dicta at most) - specification “must describe, enable, and set forth the best mode of carrying out the invention.”
The court criticized, but didn’t eliminate the “possession” test. The court clarified that it is an objective standard – focus is on the “four corners of the specification” and specification must demonstrate that inventor actually invented claimed invention. p. 24: “The level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including ‘the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.’”
p. 21: “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Court noted there is no limiting language in statute (“for purposes of priority” etc.) and no policy reason to read one into it.
Many amici argued that the doctrine fails to adequately compensate many important research breakthroughs. The court was unpersuaded by these arguments and emphasized the patent laws are intended to reward the not the search but the successful conclusion.
Last point: identify things like binding sites and types of chemical structures that would be expected to exhibit the desired function.