Posts Tagged: "patent eligibility"

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.

The baffling aspect of the opinion is that the Court seems to agree that both the DNA of claim 1 and the DNA of claim 2 are man-made and do not occur in nature. Of claim 1, the Court states that “isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule”. Page 14 (emphasis added). Of claim 2, the Court states that “the lab technician unquestionably creates something new when cDNA is made.” Page 17 (emphasis added). According to the way many patent attorneys (and Judge Rader) think, that should be sufficient to comply with §101. But the Court does not see things this way.

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.

If cDNA is patent eligible subject matter, as it seems likely based on the tone of the oral argument, that should be very good news for Myriad. As Justice Breyer recognized during questioning of Mr. Hansen (representing AMP), the Myriad claim says they want “the isolated DNA of claim 1 wherein said DNA has the nucleotide sequence set forth in SEQ ID No. 1.” If you look at SEQ ID No. 1 clearly states that the molecule type is cDNA, thus cDNA seems to be a part of the claim, not to mention that the cDNA used by Myriad was a consensus sequence made from hundreds of different patients. Thus, if cDNA is patent eligible then the Supreme Court must find that at least some genes are patent eligible and must also find the Myriad claims patent eligible. Whether the Supreme Court Justices really captured that nuance remains in doubt. It seemed at times that Justices Sotomayor and Kagan were openly arguing the AMP/ACLU case. Sadly, at times it was apparent that the Supreme Court doesn’t understand even the most basic and fundamental patent law concepts.

Two common criticisms of software patents, as compared to patents in the pharmaceutical and biotech sectors, are (a) the relatively low cost of invention; and (b) the relative ease of implementation. Are these the right factors for us to be considering for purposes of inventiveness? It seems to me that if we are going to be perfectly honest and engage in a discussion that embraces the realities of the industry we have to recognize that this criticism from those who detest software patents is based on factual fallacies. If software is so easy to create and implement why then does software of all sorts suffer from so many problems, require so many fixes and crash without warning?