Posts Tagged: "medical diagnositcs"

The medical research university is heavily involved with developments for medical diagnostics, as many of the following applications show. One patent application describes a system of searching for similar images within a medical imaging database to aid in diagnosing issues. Another patent application would protect a system of developing a personalized library of tumor development indicators for cancer patients to determine if a cancer recurrence is forming. A third application discusses a method of analyzing albumin/peptide compounds in a patient’s plasma to determine if a blood flow issue exists. Other patent applications we feature here focus on improvements to surgical procedures. One patent application explains a new development for specialized surgical robotics and an improved interface for surgeon control. Finally, we feature a patent application discussing a minimally invasive surgical treatment for obesity using a gastric sponge.

Many of these patent references reviewed this week show us Siemens involvement with electrical and Internet systems on all levels, from personal to industrial. For example, one patent application would protect a floating sensor capable of detecting foam formation in industrial liquid production, a symptom of process issues. An issued patent, with an extremely narrow Claim 1, protects a system of analyzing industrial facility processes to identify energy cost savings. On an individual level, one patent application describes a system of creating anonymity among mobile device owners using cloud application resources. Siemens is also involved in medical technology upgrades that aid various bodily systems. One patent application filed with the USPTO would protect a system of training the hearing impaired to better understand speech, even when amplification affects the signal. Finally, we feature one last patent application that discusses a system of measuring heart activity non-invasively.

Some will undoubtedly view the Chief Judge’s basis in Ultramercial for distinguishing the ruling in CyberSource as being “slight of hand” and using “mirrors,” but it certainly illustrates the wide gulf of views between the various members on the Federal Circuit on the patent-eligibility question. I wouldn’t be surprised (and frankly it needs to happen) if both Ultramercial and CyberSource ended up before the en banc Federal Circuit. As I’ve noted previously, we’ve currently got what appear to be irreconcilable decisions in the Classen, Prometheus, and AMP cases in determining the patent-eligibility of certain medical (e.g., diagnostic) methods. With what appears to be similarly conflicting decisions in Ultramercial and CyberSource, the gauntlet has truly been thrown down. An en banc Federal Circuit needs to step in soon, or the conflagration that currently exists in the patent-eligibility “war” might soon consume us all.

That there was a majority (and a dissenting) opinion in the remand of Classen wasn’t surprising. But that there was yet a third “additional views” opinion would likely not have been predicted by anyone. And it is that “additional views” opinion, along with the majority and dissenting opinions, that will certainly generate a “firestorm” through the Federal Circuit, and which may eventually reach the Supreme Court. The judicial donnybrook on the question of what the standard is (or should be) for patent-eligibility under 35 U.S.C. §101 is about to begin in earnest.

United States Court of Appeals for the Federal Circuit issued a decision in one of the patentable subject matter cases that was returned to the Court by the Supreme Court in the wake of the Supreme Court’s decision in Bilski v. Kappos. On remand, once again, the Federal Circuit held (per Judge Lourie with Judge Rader and Judge Bryson) that Prometheus’s asserted method claims are drawn to statutory subject matter, reversing for the second time the district court’s grant of summary judgment of invalidity under § 101.

With an opportunity to render some order out of the Bilski chaos, the Federal Circuit instead completely ducked the patent-eligibility issue clearly presented in King Pharmaceuticals. The Federal Circuit then created (and I do mean “created”) the new “an anticipated method claim doesn’t become patentable if it simply includes an informing step about an inherent property of that method” doctrine. With this new “doctrine,” we have now “jumped down the rabbit hole” into a surreal “Bilski in Patentland” world.

So now what does SCOTUS’ ruling in Bilski “really” mean to us “mere mortals”? First, we’ve got two “wild cards” to deal with as noted above: (1) Stevens has retired; and (2) what does Scalia’s refusal to join Parts II B-2 and C-2 of Kennedy’s opinion for the Court signify. Some aspects of “wild card” #2 are dealt with above, but as also noted, there are still some aspects which are unclear or at least ambiguous as to how this refusal by Scalia should be viewed. This lack of clarity/ambiguity will require some sorting out by the Federal Circuit, which may come as early as the reconsideration by the Federal Circuit of Prometheus, Classen, or even the appeal in AMP v. USPTO involving the gene patenting controversy. In AMP, District Court Judge Sweet’s invalidity ruling regarding the method claims for determining a pre-disposition to breast/ovarian cancer using the BRCA1 and BRCA2 genes relies at least in part upon the “M or T” test which, as noted above, SCOTUS unanimously relegated to “second class” status in Bilski as not the only test for patent-eligibility.

One reason I was quite interested in Bilski was because the Supreme Court (not surprisingly) ruled that the Federal Circuit’s “machine or transformation” test was too inflexible, much like the “teaching, suggestion and motivation” (TSM) test in KSR International v. Teleflex. So why my intense interest in the Supreme Court (aka the Judicial Mount Olympus) relegating the “machine or transformation” (aka MoT) test to “second class status” in Bilski? Besides the inanity of MoT as the sole test for patent-eligibility, I am interested because of Judge Sweet’s ill-advised reliance on MoT (now smitten by the thunderbolts from our Judicial Mount Olympus in Bilski) for invalidating Myriad’s method claims using its BRCA1 and BRCA2 gene sequence technology.

Now that the Supreme Court has vacated and remanded both the Classen and Prometheus decisions, the Federal Circuit must revisit these issues. For Prometheus, the decision may be simpler, because the claims were already held to meet the machine-or-transformation test. Although the Supreme Court’s Bilski decision held that the M-or-T test was not the only test by which patent-eligibility can be determined, the Supreme Court seemed to have agreement from all nine Justices that the machine-or-transformation test was still a useful tool and valid option. See, e.g., Bilski, slip. op. at 2 of J. Breyer’s concurrence. Although a claim that does not meet the M-or-T test may still be patent-eligible under other theories, one can presume that the M-or-T test is still a “safe harbor” for claims that meet its provisions. The Federal Circuit’s re-visitation of Prometheus will be the first opportunity for this presumption to be tested.

As I’ve said before, no one could rightly accuse me of being biased against patents. But, as I also pointed out in this article on Judge Rader’s dissent in Media Technologies Licensing, LLC v. The Upper Deck Company, I don’t believe every patent is “bullet proof,” or to use Judge Plager’s phrase, that some patents aren’t built on “quicksand.” In fact, I agree with Judge Plager’s dissent in the denial of rehearing en banc in Enzo Biochem, Inc. v. Applera Corp., issued May 26, 2010, which argues that the “definiteness” requirement in the second paragraph of 35 U.S.C § 112 needs more “teeth” than Federal Circuit precedent appears to give it.

I do have a suggested alternative on the patenting of gene sequences that is far more sensible (and won’t kill our biotech sector) than the “all or nothing” approach of the new Becerra bill. Instead of banning the patenting of gene sequences, why not provide the U.S. government with something similar to the “march-in-rights” provision that currently exists in Bayh-Dole for patented technology developed through federally-sponsored research that is underutilized? Admittedly, this “march-in-rights” provision would have to be carefully structured so it isn’t abused by the federal government, as well as those who would push for its too frequent use because they feel “entitled.”