On April 15, 2013, the Supreme Court will hear oral arguments in the Myriad Genetics v. Association for Molecular Pathology litigation. The patent world is watching, particularly those who focus on emerging technologies. On March 14, 2013, the NanoBusiness Commercialization Association filed a brief in support of Myriad Genetics (brief prepared by Foley & Lardner, LLP). In addition to arguing that the patent claims should be patent eligible, which is the essence of the case, the brief also argues that patents do not preempt others from experimenting on, improving upon, or designing around a patented invention. With today being the first day of the new first-to-file regime, patent lawyers of all stripes are busy these days keeping up with dramatic changes to the patent system. The Supreme Court could use the Myriad case to establish a new paradigm for patent eligibility. Stay tuned.
Technology Review recently highlighted new published research from IBM and others on nanoscale magnetic resonance imaging (or nanoscale NMR). Perhaps proteins can be imaged.
IBM nanoscale research is noted in this link. IBM has hundreds of granted patents falling into the class 977 nanotechnology class.
IBM symbolizes as well as anyone the convergence revolution of physical sciences, biological sciences, and information technology.
The Economist, one of the more worthy media sources these days for connecting technology to larger society, included a page on nanomedicine in its special issue, “The World in 2013.” (page 128). The article is by Professors Omid Farokhzad and Rober Langer and focuses on bio nanotechnology from BIND Biosciences. BIND recently announced a development deal with Amgen. Professor Langer is a founder of BIND and Professor Farokhzad also works closely with BIND (according to the BIND Web page). The technology is for polymeric nanoparticles which smartly carry a payload. Cancer treatment is a leading application. Patenting is an important part of the company strategy per their press releases and web page content.
Lets hope more deals are in the works for nanomedicine as 2013 moves ahead into the market place from academic research. Venture capital is an important part of this story.
The Wall Street Journal this week featured nanopore sequencing in its year end review of important health trends (both hard copy and electronic copies). The speed and low cost were stressed, as sequencing machines become desktop in size. We have noted before how the miracle of high speed sequencing is reaching the main stream press (see September 19 and July 31, 2012 posts). This nanotechnology is one of the cornerstones for personalized medicine.
I saw this recent BBC article re spiderman and nanotechnology – enjoy. The article notes the technology of one company, nanoGriptech, which is a spin-off company from Carnegie Mellon University (see Professor Metin Sitti). More generally, the article relates to bio-inspired adhesives (see geckos, for example) and applications with robotics. NanoGriptech was funded early on by the Pennsylvania NanoMaterials Commercialization Center. I encourage readers to explore this web page for interesting updates including inputs from their new leader, Leone Hermans-Blackburn.
Good to see: high throughput, inexpensive DNA sequencing is being featured on NPR this week in a series entitled the $1,000 Genome. Many of the technologies for this revolution in sequencing, of course, relate closing to or directly are nanotechnology (e.g., nanopore, microfluidic, and/or lab-on-a-chip technologies). Personalized medicine depends on it. More generally, the interface between biology and electronics is one of the most compelling arguments for further development and commercialization of nanotechnology and, more particularly, bio nanotechnology. Another leading example is allowing partially blind or blind persons to see better with artificial retinas.
A brief check of the nanotechnology class 977 patent literature shows IBM has activity in this area. See, for example, their recent US patent publications 2012/0199483 (published August 9, 2012); 2012/0193237 (published August 2, 2012); 2011/0308949 (December 22, 2011); and 2011/0279125 (November 17, 2011).
Hopefully, angel and venture capital investment will also flow to these exciting areas. This appears to be turning out to be one of many virtually secret “killer apps” for nanotech. For example, the NPR series does not delve too much into how the sequencing is done (per the series, sequencing done in a ”black box”). Hopefully, despite the secrecy, the federal and state governments, including those who fund and run the NNI, are watching.
The September 3, 2012 issue of C&EN discusses what it calls an “onslaught of nanotech drugs coming down the pike” for FDA review. See article entitled “Mapping Nanotech Drugs’ Landscape,” pp. 46, 48.
The FDA is generating a database for nanotech drugs and currently has 158 entries according to the article. The leading application area is cancer treatment (38%). Most are developed to be administered intravenously (56%). The leading types of formulation are liposomes (39%) and nanoparticles (27%).
The FDA will hold a public workshop in the coming months to get input from stakeholders for how to improve the review process.
The US patent literature confirms the role of nanotechnology innovation in cancer treatment. Of the currently published nanotechnology class 977 patent filings (there are 13,814 of them), 1.9% of them refer to cancer in the title or abstract. Considering the breadth of nanotechnology and bio nanotechnology, this is a significant fraction. Also, 4.3% of them refer to cancer in the title, abstract, or claim. Finally, 14.3% of them mention cancer in the patent somewhere.
The OSTP has recently posted a report on advanced manufacturing, which identifies eleven “cross-cutting” technologies. Of these, no. 5 is nanomanufacturing and half of the others directly relate to nanotech (e.g., advanced sensing, advanced materials, biomanufacturing, robotics, flexible electronics). The report is about 70 pages long.
Last week, it was exciting to prepare a talk on new developments in nanotechnology for the USPTO. Leading the list of exciting sub-topics was how nanotech is being used for revolutionary fast DNA sequencing, a core aspect of personalized medicine. Recent 977 nanotech patent publications focus on nanopore technology, for example. Semiconductor processing is also being used to integrate with nucleic acid sequencing in revolutionary ways, bringing down the amount of time and money needed for sequencing. Nanotech has always been looking for its “killer app” – fast DNA sequencing could be it for the second decade of the NNI. Time to increase the publicity surrounding this revolution and its source in nanotech.
The NNI is now presenting to the public a new signature initiative devoted to sensors. Two thrusts are identified: (1) use of nanotechnology in building sensors, and (2) develop better sensing methods for detecting nanomaterials. An associated white paper provides more details.
This is the fifth signature initiative from the NNI. According to the announcement, past sensor work has been held back due to problems with lack of reliability, reproducibility, and robustness. Sensors apply to a broad spectrum of industries, including energy, health, and defense. Certainly, after 9-11, sensors were identified as a key technology associated with homeland defense. Hence, federal thrusts in this sector would seem to make sense.
Some references to commercialization are present. For example, the announcement refers to US Patent No. 7,889,954 as an example of the type of technology upon which they want to build (from the Sailor group at University of San Diego). However, as if often the case with the federal government announcements, the commercialization issues at stake lack detail. For example, no patent studies are noted as part of what is important commercially in work to date. No analysis of the Bayh-Dole system in this sector or of the history of licensing or venture funding for sensor technology is noted. Brief reference to nanomanufacturing is noted (nanomanufacturing is another NNI signature initiative).
The ’954 patent, according to PTO records, is assigned to University of California and the federal government, jointly. Federal money apparently was used to develop the invention. The patent abstract for this patent is below:
An embodiment of the invention is a remote sensor that has an optical fiber terminating in a tip. A thin film porous particle having a characteristic optical response that changes in the presence of an analyte is optically coupled and physically attached to the tip of the optical fiber. The optical response of the particle changes in the presence of analyte, and the particle also serves to concentrate analyte. The thin film porous particle can be functionalized toward sensitivity for a predetermined analyte or analytes. A method of remote sensing exposes the remote sensor to an environment to be monitored for analyte. The thin film porous particle is probed with a beam of light. Reflected light is monitored through the optical fiber for a shift in frequency or intensity.
The popular news webpage msnbc.com is featuring an article in their health section on bio nanotechnology with headline, “Gene healing in a lotion? Researchers say they’re close.” Northwestern University research is highlighted, coming from the laboratories of Professor Chad Mirkin.
The technology, as you can read, relates to siRNA methods. This an active area of nanotechnology with potentially blockbuster results to impress the public mind (revolution, not evolution). For example, I noted that terms like siRNA, RNAi, and miRNA appear in 3.4% of the class 977 patent publications published to date (440 out of 12,982). Also, a review article including IP and interference technologies and nanobio has been posted on the web.
One subject to watch in 2012 is diamond. Synthetic diamond is one important arrow in the arsenal of advanced materials and is an essential part of the carbon based nanomaterials scene including familiar materials in the press such as fullerenes, carbon nanotubes, and graphene. Synthetic diamond films and powders, however, are also an important part of nanotechnology 2012, as it can have grain sizes at the nanoscale. Indeed, class 977 nanotech patent efforts on diamond seems to be increasing. In 2011, a record number of class 977 patent applications – 28 – included diamond in the title or abstract. In 2010, that number was only 18 and the year before was only 11. Some important diamond applications lead to energy savings and better electrodes, so it is also an important material for energy and cleantech. Biosensor applications also exist.
An excellent historical treatment of the development of synthetic diamond technology is Robert M. Hazen’s book, The Diamond Makers, 1999. A major player in the field was General Electric, which continues to this day to be a leading force in advanced materials, nanotech, and cleantech.
In the conception of manufacturing at an atomic, molecular, or nanoscale, inventors and futurists have always thought of building the perfect material: diamond.
The DOE just released its December 2011 report for “Critical Materials Strategy.” The report is about 190 pages with about a third of that being appendices. Subjects of focus include the cleantech subjects of wind turbines, electric vehicles, photovoltaic thin films, and energy-efficient lighting. The report is not totally new but represents an update of a prior 2010 report.
Key conclusions include: (1) rare earth elements play an important role in petroleum refining, but the sector’s vulnerability to rare earth supply disruptions is limited, (2) manufacturers of wind power and electric vehicle technologies are pursuing strategies to respond to possible rare earth shortages, and (3) as light energy efficiency standards are implemented globally, heavy rare earths used n lighting phosphors may be in short supply. DOE strategies include, for example, (1) diversifying the global supply chain, (2) developing substitutes, and (3) recycling, reuse, and more efficient use is important for newly extracted materials.
Nanotechnology has made it again into some mainstream press. The December 3, 2011 edition of The Economist has a 28 page Technology Quarterly which is a must-read for those that follow nanotech. Nanotechnology’s role in commercialization efforts is noted in several of the articles – good to see!
First, there is “Getting Past the Guards,” an article on the health side of nanotech regarding delivering pharmaceutical drugs past the body’s natural defenses (pages 18-19 in the paper edition). One such defense is the blood-brain barrier. Another is the small size of blood capillaries. Anticancer drugs can clump too much and cause blocking in the small capillary. Recent research is reported, however, where drug particles are converted to nanoparticles with a combination of sound waves and use of polymers to form shells. Certainly, cancer treatment is one blockbuster application of nanotech which should be stressed to government officials in charge of government funding and commercialization policy. An article is also attached on delivery of drugs across the blood-brain barrier using nanotechnology.
Patent filing data are suggesting (if not confirming) that nanotechnology is an increasingly important technology sector in the U.S. For example, in 2004, the US PTO created the 977 nanotechnology class which provides a useful metric. In 2011, the 10,000th nanotechnology 977 patent publication published. The current patent publication count stands at 10,735 (as of December 8, 2011). Of these, 3,223 were published in 2011 which is about 30%. About 70% of the 10,735 have published in the past three years (2009-2011). An explosion this is.
Patent publications are a leading indicator for current trends in patenting. Because patents can take 2-6 years to grant, typically, patent publications are a more sensitive measure for the trends. Moreover, not every patent application is granted, which further skews the analysis if one focuses only on granted patents.
During the July 14, 2011 Senate hearing regarding NNI reauthorization, noted here in a prior July 14 blog, a Senator asked the panel for examples of leading nanotechnology "blockbusters." Examples included diagnostics and even oil/gas mud drilling fluid!
One nanotech result seems to be gaining more press as a potential blockbuster. The last Technology Review (August 2011, p. 84) features research from IBM and other organizations on nanostructured copolymers which can destroy microbial membranes. The trick is that (hopefully) bacteria will not be able to develop resistance in this approach, because the approach is physical and not chemical. At least one patent filing has published which appears to relate to the technology. This patent publication was not classified as a 977 nanotech patent, which would seem to be a problem. Interesting, however, to see a computer company like IBM leading the nanomedicine charge including international collaborations with Singapore and Chinese groups! Other press about this development is attached.
Nanotechnology made headline news this week with an inspiring, good news nano biotechnology health story, as reported in the Wall Street Journal (on-line).
A medical team led by Dr. Paolo Macchiarini in Sweden was able to insert a lab made trachea in a patient suffering from throat cancer. Nanoengineered polymers were used. No cadavers were used. The materials were developed by Alexander Seifalian at University College of London. See, for example, Seifalian patent, US Patent No. 7,820,769.
According to the WSJ article: "The windpipe is a hollow tube, about 4.5 inches long, leading to the lungs. A key part of it is a scaffold—which functions like a skeleton for the organ—consisting of tissues such as cartilage and muscle. As a first step, a team led by Alexander Seifalian of University College London used plastic materials and nanotechnology to make an artificial version of the scaffold in the lab. It was closely modeled on the shape and size of the Eritrean man’s windpipe."
I was impressed recently by all of the truly exciting innovations and science policy issues which are now reported in the media so fast that it has become difficult to keep up. Recall the saying: so many books; so little time!
For example, nanotech, cleantech, and printed electronics were all featured in the last Economist Technology Quarterly (March 12, 2011). First, use of nanopores for rapid DNA sequencing was highlighted (pages 13-14). In addition, flexible electronic circuits also were noted (pages 15-16). Finally, Vinod Khosla’s controversial ideas re cleantech were explored (pages 22-23).
Time magazine this week (February 21, 2011 issue) featured a cover story related to more distant aspects of nanotechnology including "humanity’s immortal future." The cover has the story: 2045: The Year Man Becomes Immortal. (If you believe humans and machines will become one. Welcome to the Singularity movement.)
Back on pages 42-49 of the printed version, the story of Singularity unfolds, with several references to nanotechnology and nanotechnology patents. The gist is that technological development is occurring at an exponentially faster rate, and at some point, machines/computers become like people, and vice-versa. People can become immortal; aging stopped. The ideas and biographical background of writer Ray Kurzweil are featured. Evidence for exponentially include the rate of nanotech patenting!
I pass on some information which stems from a conference I attended in December on federal research programs in nanotechnology (NNI at Ten event), which also included nanotech work at the National Cancer Institute (NCI). In case you want to read more on nanotech approaches to winning the war on cancer, the NCI also published recently an excellent 11-page review article.
Part I of the article provides background and program achievements. For example, US research centers are given in Figure 1. The number of cancer and nanotechnology research articles in 2009 has more than tripled since 2003 (Figure 2). Research relates to diagnostics, therapy, drug delivery, assays, imaging, etc. About 50 commercial entities are involved with this effort in addition to the fundamental university, hospital, and federal laboratory work.
The important and controversial story of the discovery of "nanobacteria" was recently summarized in the book, Every Living Thing, Man’s Obsessive Quest to Catalog Life, from Nanobacteria to New Monkeys (by Rob Dunn, 2009). Readers interested in how nanotechnology may impact human health should monitor this subject. What is the role of nanoparticles in our bodies, difficult to detect and characterize, in our human health?
Congratulations to the nano biotechnology company, NanoBio: See recent articles, below, e.g., "NanoBio Nabs $6M from Gates Foundation for Nasal Spray Vaccine". Hopefully, the nanoemulsion technology will allow one to avoid needles and promote global health.
Prominent billionaires like Bill Gates, Warren Buffett, and Ted Turner have been in the news media recently talking about how and why they "give" money away. It will be interesting to see what else can be given to nanotechnology, nano biotechnology, and cleantech. And, what kind of creative licensing arrangements can be achieved to create "win-win" outcomes? What strategy will they use to promote health in poor countries, and will they also turn to venture capital types of strategies at all?
Has nanotech’s time come? As Warren Buffet allegedly has said, "If you wait until you see the robin, spring will already be over. Buy soon, or you will miss the opportunity." (Also, Christmas is here. :)
We wanted to review a case which we can call the case of the “self-serving” NDA. Let me explain:
One critical application of nanotechnology is in sensing, whether used for medical diagnostics or cleantech. For example, the NNI has recently produced a fifty page report on nanotech sensing at www.nano.gov (“Report of the National Nanotechnology Initiative Workshop, May 5-7, 2009”). When a sector of nanotechnology, such as sensing, becomes the subject of patent and/or trade secret litigation, this signals that the market for the technology has arrived.
One recent IP litigation has been focused on commercial products for nanotech sensing for glucose monitoring, and an important decision was just rendered. In reading these developments, lessons can be learned with respect to non-disclosure agreements, patent filings, and joint development. Many companies, of course, need to pursue joint development strategies in the real world, and the risks associated with joint development must be managed wisely.
To Read More about the Case of the Self-Serving NDA:
Big news emerged last week about one more step taken from the scientific laboratories toward the concept of artificial life.
First, before more comments on that news, some context: nanotechnology relates to revolutionary control of matter at the nanoscale. This mission encompasses biological matter, which provides a connection between nanotechnology and other fields such as synthetic biology and biotechnology generally. We often see the terms “nano biotechnology” or “nanomedicine” as further capturing these interdisciplinary themes. Controlling matter on the nanoscale means also controlling life forms and at least theoretically making new life forms. One can argue that creating new life forms is still science fiction. OK, granted, but keep reading.
In that context, nanotechnology and synthetic biology made national, world news last week when the group led by Craig Venter (J. Craig Venter Insitute, JCVI) published a paper in Science on what some have said is the creation of the world’s first self-replicating, synthetic cell. The abstract for the paper is included at the end. The JCVI press release is here.