Archive for the ‘Patentable Subject Matter’ Category

MYRAID APPEAL UPDATE: WHO’S RECUSING WHO?

Monday, August 9th, 2010

Subtitle: “Who’s Your Amicus, Baby?” On July 19th, various Blogs reported that the ACLU (Plaintiffs’ attorney in the appeal of the district court’s ruling in the case sensibly abbreviated by Hal Wegner as AMP v PTO) filed a motion in the Federal Circuit seeking to recuse Chief Judge Rader on the basis of allegedly pro-DNA comments he made at a symposium at the International BIO Conference in May. The session was chaired by Jennifer Gordon of Baker Botts, who authored BIO’s amicus brief filed in AMP v. PTO at the district court level.  I have read this well-reasoned “law and policy” brief, and it provided an outline for Judge Sweet’s opinion that rejected pretty much every word of it.

More recently, the Federal Circuit Bar Association has raised the visibility of this motion by filing an amicus brief authored by Edward Reines and Amber Rovner of Weil, Gotshal in support of neither party but espousing the standard for recusal based on a judge’s statements at a conference:

“If the Judge’s comments can reasonably be understood as general expressions regarding the law, recusal is not warranted, even if the views expressed are also relevant to particular pending or impending case. Correspondingly, recusal should be considered, based on such comments, only if the objectively reasonable interpretation is that those comments constituted the expression of the judge’s specific views regarding the proper disposition of a particular identifiable pending or impending case, and reflect bias or predisposition (i.e., an unwillingness to consider the case with an open mind.)”

All clear?  Let’s try this, from page 9: “Simply put, participation in an organization’s event does not imply adoption of every position taken by the organization as an amicus or otherwise.  [Unfortunate cite department]: See generally In re Charges of Judicial Misconduct, 404 F.3d at 694….case-specific conferences are the exception, not the rule, however, and in the absence of such unusual circumstances [judge approved funding for conference which included a ‘Hollywood-style pre-screening of the plaintiffs’ case] a judges attendance at a conference or educational retreat should not lead to disqualification.”

Well, I never saw anything at a BIO conference so flamboyant that could be called “Hollywood-style” but neither was the judge attending a CLE course at a scholarly retreat.  This may not be over by a long shot, particularly since the issue on appeal can be summarized in one short sentence (see below).

One Fed. Cir. Judge that the ACLU is not going to try to disqualify is Judge Dyk. In Intervet, Inc. v. Merial Ltd., Appeal No. 2009-1568 (Fed. Cir. 2010), the Judge wrote a concurrence-in-part and a dissent-in-part, to emphasize that the issue of whether or not certain of the claims that had been construed by the court had implicitly condoned that “isolated DNA claims” embraced patentable subject matter.  The Judge wrote:

“The question is whether the isolated DNA molecule [apart from its uses] is patentable subject matter. Neither the Supreme Court nor this court has directly decided [this question].  Although we have upheld the validity of several gene patents…none of our cases directly addresses [this question]….I think such patents do in fact raise serious questions of patentable subject matter….allowing the patentability of naturally occurring substances [would] preempt the use by others of substances that should be freely available to the public.”

Please wait one minute, Judge Dyk, the form in which the public uses their DNA (in their chromosomes) remains “freely available to the public.”  No one has seriously argued that a patent on an isolated DNA sequence that is part of the human genome would permit the patentee to go up to a passer-by and demand a royalty because he/she is using the gene in an infringing manner.  In an analogy that could have been drawn by the ACLU attorneys, who have likened isolating DNA from the genome to picking gold nuggets out of a stream: “The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question [Who said it did?].  It would be difficult to argue for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.” Here is a Judge who has never heard of, or read the lyrics of, “Autumn Leaves.” I sure hope he finds time to read the BIO amicus brief before he “reflect[s] bias or predisposition” – again.

Rader’s Dissent in Bilski – Keeping It Real

Monday, July 19th, 2010

Discussing a particularly convincing dissent, commentators frequently are compelled to close with: “But it was a dissent.” The most influential dissent in recent months may well be Judge Rader’s dissent in In re Bilski, 545 F.3d 943, 1011 (Fed. Cir. 2008). It was cited twice in the opinion of the court in the recent Supreme Court decision which held that the “machine or transformation” test was overly limiting on processes and that the Bilski claims were directed to an abstract idea (unpatentable under s. 101).

This is exactly how Rader would have disposed of Bilski when the appeal was before the Federal Circuit. He opens his dissent:

“This court labors for page after page, paragraph after paragraph, explanation after explanation to say what could have been said in a single sentence: ‘Because Bilski claims merely an abstract idea, this court affirms the Board’s rejection.’”

The Supreme Court’s Bilski decision has been criticized for providing little in the way of guidance as to exactly when an invention falls into the “abstract idea” category. Judge Rader spends more time on this problem than did the Supreme Court:

“[A]bstract ideas can never qualify for patent protection because the Act intends, as section 101 explains, to provide ‘useful’ technology. An abstract idea must be applied to (transformed into) a practical use before it qualifies for protection. …When considering the eligibility of ‘processes,’ this court should focus on the potential for an abstract claim. Such an abstract claim would appear in a form that is not even susceptible to examination against prior art under the traditional tests for patentability. Thus this court would wish to ensure that the claim supplied some concrete tangible technology for examination. Indeed the hedging claim at stake in this appeal is a classic example of abstractness. Bilski’s method for hedging risk in commodities trading is either a vague economic concept or obvious on its face. …In any event, this facially abstract claim does not warrant the creation of new eligibility exclusions.”

The Supreme Court could not have agreed more. The problem is that Bilski’s claim does not seem all that abstract. It is certainly not in the same league as abstract ideas like The Golden Rule or “The love you take is equal to the love you make.” These abstract ideas are philosophical propositions that no one would expect an Examiner to be able to examine, even though their value to society can be debated ad infinitum. But some claims to new methods of directing or organizing human behavior to achieve (e.g., a business or a healthcare outcome) can certainly be searched against a body of prior art, although it may be difficult to do so. The Supreme Court did not rule out patents on this type of invention. It will remain for future decisions to put legal flesh on the bones of “some concrete tangible technology.” We now know that it has to be more real than a “useful, tangible and concrete result.” Just how much more real remains to be seen.

In_re_Bilski_and_Warsaw

Prometheus v. Mayo and Classen v. Biogen Sent Back to Federal Circuit

Tuesday, June 29th, 2010

Not unexpectedly, today the Supreme Court granted cert. in Prometheus v. Mayo, (09-490) vacated, and remanded to the Fed. Cir. for reconsideration in view of Bilski v. Kappos, decided yesterday. While this clears the Court’s collective desk, I don’t see anything in Bilski that would either cause the Fed. Cir. to reverse its original decision or cause the Supreme Court to reverse an affirmance.  As you will recall, the claims in Prometheus were directed to a method of administering an immunosuppressive drug and monitoring the level of its metabolites to determine the appropriate dosage. While the Fed. Cir. found that certain of the steps were “mental steps,” the panel both found the administration steps and the sampling steps to be transformative, and strongly reaffirmed that methods of medical treatment were patentable methods or processes under s. 101. Given that the M or T test is still viable and given that even the Justices who sided with Justice Stevens should find that these claims are not directed to a business method and involve more than simply organizing human activity, it is hard to envision what circumstances would cause any of the Justices to reverse a decision below that the claims are patentable subject matter.

The Supreme Court also granted cert., vacated and remanded Classen Immunotherapeutics Inc. v. Biogen IDEC (08-1509) for reconsideration in view of Bilski. The Fed. Cir. summary affirmance of the district court’s holding that the claims of US Pat No 5,723,283 are invalid as failing the M or T test was the subject of one of my first posts on this blog in March 2009. The claims were directed to determining whether or not an immunization schedule is effective in treating a chronic immune-related disorder. Claim 1 contains the steps of immunizing mammals with dose(s) of immunogens according to the schedule and comparing the results with that of a control group. The district court found that the claims were invalid; an attempt to patent a natural phenomenon. The Fed. Cir. affirmed on the basis that the claims fail the M or T test. I argued at the time that immunization transforms the immune system. The immunization schedule can, in some cases, ameliorate the symptoms of the disorder. Regardless of whether or not the Fed. Cir. reapplies the M or T test, this claim is not directed to an abstract idea or a law of nature. The Fed. Cir. got it wrong the first time, even if it were proper to use the M or T test as the sole test to evaluate whether this method is patentable subject matter (which we now know it is not). The Bilski decision gives the court a rare opportunity to change its mind.

As I have noted in earlier posts, more problematic are certain of the diagnostic or “screening” method claims the Fed. Cir. will be required to consider after the Ass’n of Molecular Pathology (read “ACLU”) vs. USPTO and Myriad district court decision crosses their threshold.  The ultimate decision in this case will not turn on whether or not a diagnostic method is a business method, since none of the parties ever urged that it is. (Query: Is a surgical method a business method? What about a chiropractic technique?)

“Abstract idea” was also not defined by the Court’s opinion, and since this exception to patentable subject matter sealed Bilski’s fate, should we now be asking: “Can diagnostic methods be so technologically disembodied that they are ‘abstract ideas’”?  Judge Sweet found that the “analyzing” and “comparing” steps in Myriad’s screening claims were abstract mental processes that failed the M or T test.  Of course, post-Bilski, the Fed. Cir. has more to work with than just the M or T test – too bad we don’t know how much more!

Appeal Summary Disposition

VENTER GROUP LABELS SYNTHETIC LIFE “PAT. PENDING”

Monday, June 7th, 2010

In the May 20th issue of Science Express, a group led by Daniel Gibson, Hamilton Smith and  J. Craig Venter published an article that got the full attention of scientists, bioethicists and IP attorneys worldwide: “Creation of a Bacterial Cell Controlled by a Chemically-Synthesized Gene. “ The methodology employed was well summarized by Elizabeth Pennisi in her introduction to the paper: “Synthetic Genome Brings New Life to Bacterium” (Science, 328, 958 (May 21, 2010)) and in the article itself, as well as by patentdocs.org, and so does not need undue replication here.

After the Venter group was able to successfully transfer the entire genome (one chromosome, in this case) of a simple bacterium to another related species, and demonstrated that they could synthesize an artificial chromosome that was labeled so it could be tracked, the group set about to synthesize the 1-million-base genome of the bacterium M. mycoides and transfer it into the related species M. capricolum. The starting-point sequence was available online (no patent problems there, Judge Sweet), so the group bought one thousand 1080-base sequences from a DNA-on-demand company and set about to assemble them into “a completely assembled synthetic genome.” (Note to file: How did the group select the individual 1080 base sequences they ordered? See US 2010/0041035 A1.)

A functional yeast clone was obtained and transplanted into M. capricolum. The synthetic genome was “watermarked” with preselected unique sequences so the group could tell it was “theirs”. Using a conventional marker gene allowed them to identify functional transformed bacteria that contained the synthetic chromosome, which they further characterized by sequencing and protein profiling. (Note to file: Use Fig. 1 of the Science paper to train junior biotech associates in modern transgenic methodologies.)

 Although Ms. Pennisi states that commentators “emphasize that this work didn’t create a truly synthetic life form, because the genome was put into an existing cell,” Venter et al. are not quite so restrained. To quote from the Science paper:

 “We refer to such a cell controlled by a genome assembled from chemically synthesized pieces of DNA as a ‘synthetic cell’ even though the cytoplasm of the recipient cell is not synthetic [Note to file; neither is the cell wall]. Phenotypic effects of the recipient cytoplasm are diluted with protein turnover and as cells carrying only the transplanted genome replicate. Following transplantation [of the synthetic genome] and replication on a plate to form a colony…progeny will not contain any protein molecules that were present in the original recipient cell….The properties of the [progeny] cells controlled by the synthetic genome are expected to be the same as if the whole cell had been produced synthetically (the DNA software builds its own hardware). “

 A quick search for published patent applications directed to this feat (and its future) yielded Venter et al., published application US 2007/0264688 A1 (Nov. 15, 2007). Here are a few representative claims:

1. A method for constructing a synthetic genome comprising:

assembling nucleic acid cassettes that comprise portions of the synthetic genome, where at least one of the nucleic acid

cassettes is constructed from nucleic acid components that have been chemically synthesized, or from copies of chemically-

synthesized nucleic acid components.

 

2. The method of claim 1, wherein the genome is a non-naturally occurring genome.

 

14.  The method of claim 1, wherein an entire synthetic genome is constructed from nucleic acid components that have been chemically synthesized,

or from copies of the chemically synthesized nucleic acid components.

 

32.  A synthetic genome.

 

34. A synthetic cell comprising a synthetic genome.

 

38. A method comprising:

designing a synthetic genome;

constructing the synthetic genome;

introducing the synthetic genome into a biological system; and

expressing said genome.

 

How’s that for a glimpse into the future of “patenting life”?