Posts Tagged: "patentability requirements"

By holding that Myriad’s claimed cDNA was patent-eligible, Thomas’ opinion reaffirms the major holding in Diamond v. Chakrabarty that claimed subject matter which truly only the “hand of man” can make (not simply snipped out of “mother nature”) will make it to the patent-eligibility zone. (Whether that same cDNA makes it to patentability zone under 35 U.S.C. § 102 and especially under 35 U.S.C. § 103 is another and far more important story.) I would also be careful in reading too much into Thomas’ statement (which is also dicta) about “very short series of DNA which may have no intervening introns to remove in creating the cDNA” might be patent-ineligible. By definition, cDNA (i.e., complementary DNA) is a DNA molecule which is created from mRNA (i.e., messenger RNA) and therefore lacking the introns in the DNA of the genome. Thomas (or his clerks) may not have realized that what they were talking about isn’t what would be defined (at least by a molecular biologist) as cDNA. So the impact of that statement should have minimal, if any impact.

USPTO to Examiners: “As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101.”

You can expect a near complete cessation in many areas of personalized medicine. If creating something in a lab, such as a composite cDNA, does not make the underlying claims patent eligible because what results is indistinguishable from what appears in nature that means that the fledgling and potentially promising technologies to grow organs for transplantation will shrivel up and die. The whole point is to create an organ that is indistinguishable from what appears in nature so that it can be transplanted into a human body to prolong life. Given the breadth of this opinion and the uncertainty it will cause funding will dry up in the U.S.

Under what authority does the PTAB ignore specifically recited structure? The authority that the PTAB seems to be relying on to ignore claim terms is unclear and not explained in the opinion in any satisfactory way. It does, however, seem that the fact that the invention can be implemented in any type of computer system or processing environment lead the PTAB to treat the method as one that could be performed on a “general purpose computer,” rather than a specific purpose computer. Thus, the PTAB picks up on the arbitrary and erroneous distinctions between general purpose computer and specific purpose computer without as much as a thought and wholly without factual explanation.

This section does not say anything about the claims and while the claims define the invention they are not the invention. To suggest otherwise is to confuse reality and elevate the draftsman’s art above the inventor’s work. The CAFC and the Supreme Court are being contradictory when they state that the manner or cleverness of drafting the claims cannot overcome a 35 USC 101 issue and then examine those same claims to make a 35 USC 101 determination.

In a one-page memorandum to the Patent Examining Corps dated May 13, 2013, Deputy Commissioner for Patent Examination Policy Drew Hirshfeld had a simple message to respond to the Federal Circuit’s en banc non-decision in CLS Bank v. Alice Corp. The message was this: “there is no change in examination procedure for evaluating subject matter eligibility.”

Why have claims if the claims don’t matter. Essentially Judge Lourie, and the Canadian Patent Office too, are saying ignore the claims and read the specification to determine what the innovation is and then without regard to the language of the claims make your determination. Under this viewpoint claims are simply irrelevant. Yet we know that claims are not irrelevant, and such a view is directly contrary to the Patent Act itself. Ignoring claims is utterly ridiculous given inventions are not patentable. Patent claims are supposed to be evaluating NOT the entirety of the invention. The sine quo non of patents are the claims. It is black letter law that the claims define the exclusive right granted. Ignoring the claims shows reckless disregard for the well established law and is nothing short of judicial activism.

The first thing that any student of the Federal Circuit likely notices when reading CLS Bank is that Judge Lourie not only joined the dominant concurrence, but he also wrote the opinion. The same Judge Lourie who wrote the first opinion in Mayo, after which the Supreme Court asked the Federal Circuit to reconsider, and who then wrote the second opinion in Mayo. The same Judge Lourie who wrote the first opinion in Myriad, after which the Supreme Court asked the Federal Circuit to reconsider, and who then wrote the second opinion in Myriad[12]. All of those opinions interpret §101 broadly. What changed?

While the Supreme Court has done away with the “useful, concrete and tangible result” test from State Street Bank v. Signature Financial, in Bilski v. Kappos, 8 out of 9 Justices (i.e., everyone except Justice Scalia) signed onto an opinion that recognized that the patent claims in State Street displayed patent eligible subject matter. Indeed, the dissenters in Bilski specifically acknowledged that the claims at issue in State Street did not deal with processes, but dealt with machines. See Footnote 40 of the Steven’s dissent. The import of this is that machines are specifically patent eligible subject matter, so if the claims of State Street are to machines then claims that are similarly configured would also be directed to machines and therefore patent eligible.

Watson? It is an artificially intelligent computer system that is capable of answering questions presented in natural language. It is, in essence, the modern day equivalent to the all knowing Star Trek computer. It is flat out ridiculous to be asking whether the Star Trek omnipotent computer could be patent eligible, that that is where we find ourselves because what makes the computer unique is the software that makes it possible for Watson to perform 80 trillion operations per second. But Federal Circuit Judges say that mere fact that software is fast doesn’t make it patent eligible unless there is some kind of uniqueness to the computer itself. Have we really reached the point where truly astonishing innovations, innovations once thought to be impossible, are not patent eligible? Talk about jumping the shark!

Perpetuating the myth that the computer is where the magic lies does nothing other than ignore reality. Software is what makes everything happen. or crying out loud, software drives a multitude of machines! Maybe the auto mechanic for Judges Judges Lourie, Dyk, Prost, Reyna and Wallach should remove the software from their cars. Perhaps as they are stranded and forced to walk to work they might have time to contemplate the world they seem to want to force upon the rest of us; a world hat clings to mechanical machines completely non-reliant on software. That will be great for the economy!

The only thing we know is this — the Federal Circuit issued an extraordinarily brief per curiam decision, which stated: “Upon consideration en banc, a majority of the court affirms the district court’s holding that the asserted method and computer-readable media claims are not directed to eligible subject matter under 35 U.S.C. § 101. An equally divided court affirms the district court’s holding that the asserted system claims are not directed to eligible subject matter under that statute.” Thus, the asserted claims are not patent eligible.

The Honorable Alex Kozinski immediately posed the question—by way of an analogy to scientists who stare at the stars—of why should someone be able to get a gene patent just because there was a significant amount of effort put in to discover that gene. Throughout the event, Judge Kozinski took on the role of the generalist judge, who would need to be convinced that the invention in the lab is anything other than a product of nature. Professor David Winickoff of UC Berkeley followed that question up by discussing James Watson’s amicus brief and the idea that genes are both symbolic in our culture and shared by all humans, thus making them a unique item in our world.

One side in the “gene patent war” has nevertheless convinced the Supreme Court to weigh in on the issue of whether DNA sequences derived from the human genome are patentable, in Association for Molecular Pathology (AMP) v. Myriad Genetics, while disingenuously labeling the patents at issue as “human gene patents.” Let’s set the record straight.

As Myriad has correctly pointed out in its brief in opposition to the grant of certiorari, the question posed by the ACLU/PubPat (“Are Human Genes Patentable”) is absolutely the wrong one to answer: “The first question presented [by the ACLU/PubPat] bears no relation to the uncontroverted facts of this case.” (Myriad’s brief in opposition has also pointed out at least 4 other significant factual and legal “misstatements” made in the petition for certiorari by ACLU/PubPat.) As much as the ACLU/PubPat (and others) want to make the Myriad case into about “Who Owns You,” what Myriad has claimed does nothing of the sort. In fact, a “yes” answer to the question posed by the ACLU/PubPat does not automatically lead to Myriad’s claimed “isolated” DNA sequences being patent-ineligible. Those claimed “isolated” DNA sequences are not “genes” by any standard molecular biology definition of what that term actually means. Instead, and as accurately characterized by Judge Lourie, these claimed “isolated” DNA sequences are “novel biological molecules.”