Category: Bionanotechnology



I recently came across a very interesting article that was written in the Summer of 2008, Nanoparticle-based Therapies in Humans: A Survey, available at The subject matter deals with medical therapies for humans that contain nanoparticles. The author explores the emerging area of medicine that incorporates nanotechnology to fill the gaps of traditional delivery systems (i.e. poor water solubility and lack of target specificity). In addition to gap filling, the therapies stand poised to take the medical field to a whole new level, and will pose a myriad of challenges for the FDA, the U.S. Patent and Trademark Office (PTO), and patent attorneys worldwide.

Some Broad Background:

It is important to understand why nanoparticles are responsible for the proliferation of a new way to deliver medicine to the ailing human body. Traditional delivery systems lack the specificity element and the medicine tends to be delivered in higher than necessary doses that could lead to possible toxic exposure to the patient. Also, the human body is a hostile environment which reduces the effectiveness of traditional drugs.

The author of the article pointed out the following benefits with regard to the developments in nanomedicine:

Nanoparticles are selected for properties such as biodegradability, biocompatibility, conjugation, complexation or encapsulation and their ability to be functionalized. There are two types of nanoparticle-based therapeutic formulation: (1) those where the therapeutic molecules are the nanoparticles (therapeutic functions as its own carrier); and (2) those where the therapeutic molecules are directly coupled (functionalized, entrapped or coated) to a carrier.

Another important and desirable property of nanoparticles is the “surface area effect” that occurs. As a particle’s size decreases, the number of atoms on its surface increases relative to those at the core. This results in an exponential increase in reactivity which equates to increased efficiency and effectiveness over larger molecule delivery systems.

Patents and Commercialization:

It is critical for a company to obtain valid patents if they have any hope to profit from the research and development efforts of producing a new drug delivery system. According to the author of the article I read, the current state of nanoparticle patents is confusing at best. He states, “the proliferation of nanoparticle patent applications filed at the PTO, coupled with the continued issuance of surprisingly broad patents by the PTO, is creating a chaotic, tangled patent landscape where competing players are unsure as to the validity and enforceability of numerous issued patents.”

In an earlier post, Nanobots, Patents, and Collaboration, I proposed that innovation through collaboration is likely the most ideal way to navigate in this emerging area of technology. It seems as though there is no clear guidance in light of the Bilski decision, other than the probability is high that broad patents will continue to issue (not a bad thing, but not helpful to those involved in developing the multilayered drug delivery systems). I find myself a bit conflicted because I am a proponent of patent protection, but I am a realist and understand that the smaller the technology goes, the more overlap that occurs between competing patents. Again, I assert that collaboration is key and I look forward to participating in the process.

nanotechnology-on-health-area-photoThe University of Buffalo recently unveiled a dramatic development in the nanotech realm. Through the use of magnetic nanoparticles it is possible for scientists to “remotely control ion channels, neurons and even animal behavior.” There are many possible real-world applications of this technology including targeted cancer, diabetes, and neurological disorder treatments.

The method utilized in the control of animal behavior involves the use of magnetic nanoparticles which have entered into the cell membrane of the nematode C. Elegans. The size of the particles, only six nanometers, is essential for the easy movement into the cell membrane. Once situated, the subject was exposed to a magnetic field (much like the intensity of an MRI) and the nanoparticles were heated to 34 degrees Celcius (93.2 degrees Fahrenheit). The worms, which had been moving in a forward direction, move in the opposite direction when the temperature rose.

Group of C. Elegans worms prepared by UB team with nanoparticles at their sensory neurons respond to the application of a magnetic field. To learn more, visit

“We targeted the [magnetic] nanoparticles near what is the ‘mouth’ of the worms, called the amphid,” explained Arnd Pralle, PhD, assistant professor of physics. “You can see in the video that the worms are crawling around; once we turn on the magnetic field, … most of the worms reverse course. We could use this method to make them go back and forth. Now we need to find out which other behaviors can be controlled this way.”

The implications of this breakthrough could just as easily be applied to humans. Already, there are groups utilizing magnetic nanoparticles to battle cancer cells in a very targeted manner. But, the net is cast wider with the application to remotely controlling animal and human behavior.

In the legal arena, one could pose the question “Is this discovery worthy of patent protection?” Post Bilski, 2010 WL 2555192, the question might easily be answered with regard to patentable subject matter and processes. Now that the machine or transformation test is not exclusively definitive, it is more likely than not the process of heating magnetic nanoparticles to cause a living organism to behave differently would clear the first hurdle on the path to a patent. Of course, the battle would continue in the ‘non-obvious’ and ‘prior publication’ stages, however, innovation is not stifled and the legal battles rage on.


The paradigm to determine the patentability of inventions involving nanotechnology and biotechnology continues to evolve due to the Supreme Court deciding the case of Bilski v. Kappos, 2010 WL 2555192.  The Court heard oral arguments on November 9, 2009, and the opinion was issued on Monday, 28 June 2010.

The trouble for Bilski began when he and his business partner, Warsaw, applied for a patent on a computerized method for incorporating weather information into the speculation of future prices of commodities and energy costs (business method). The claim was denied by the Patent and Trademark Office (PTO) for lack of patentable subject matter (process), and the denial was affirmed in subsequent appeals to the PTO and the Federal Circuit. The Supreme Court decision affirmed the denial of the business method’s patentability, but it simultaneously held the test, utilized by the Federal Circuit, for determining if a process is proper patentable subject matter was not the exclusive and sole determining factor. Going forward, this decision will have a major impact on what constitutes patentable subject matter (the first hurdle on the road to a patent being issued), including those discoveries that have helped to fuel the explosion of cutting-edge bio/nanotechnology.


Throughout the litigation history, the focus was squarely on the ‘machine or transformation’ requirements articulated by the PTO and further solidified by the Federal Circuit.  The court relied on the two prong test set forth in Gottschalk v. Benson to determine whether a process claim is tailored narrowly enough. “A claimed process is surely patent-eligible under § 101 if:  (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” The Federal Circuit outlined the task at hand, “It is undisputed that [Bilski’s] claims are not directed to a machine, manufacture, or composition of matter. . . . Thus, the issue before us involves what the term ‘process’ in [the law] means, and how to determine whether a given claim . . . is a ‘new and useful process.’”  Essentially, the legal issue generating all the consternation and strife is: “[W]hat test or set of criteria governs the determination by [PTO] or courts as to whether a process is patentable?”  The Federal Circuit opined that a process is not patentable subject matter unless it exactly conforms with the ‘machine or transformation’ test.


The Supreme Court agreed to hear the case, but rarely hears a case from the Federal Circuit to explain that they reached the correct and appropriate conclusion. Quite to the contrary, the Supreme Court seems to take case after case in the patent area to fix a wrong perpetrated by the Federal Circuit. This tension has been in place for quite some time.

At oral arguments before the Supreme Court, Justice Sotomayor voiced concern over the harsh majority opinion of the Federal Circuit:

How about we say something as simple as patent law does not protect business matters instead of what the Federal Circuit has begun to say, which is technology is tied to a machine or a transformation of the substance, but I have no idea what the limits of that ruling will impose in the computer world, in the biomedical world, all of the amici who are talking about how it will destroy industries?

That sentiment reverberated in the unanimous majority opinion whereby the ‘machine or transformation’ test was relegated to the role of a helpful clue in determining whether or not a process is patentable subject matter. Essentially, the Court rejected the Federal Circuit’s exclusive reliance on the bright-line rule and threw the proverbial ball back into their court to develop an appropriate test. The bottom line, as it stands now, is that patentable subject matter is still quite broad, and the analysis to determine it includes the ‘machine or transformation’ test as one criterion with regard to processes, but it no longer is the sole deciding factor.


If the Supreme Court had required strict adherence to the machine or transformation test, it would have had seismic implications for patents already issued, and certainly would have caused trouble for pending applications relating to biotechnology and nanotechnology.  The trouble arises from the precarious position that biotech and nanotech patents are not theoretically involved with either a machine nor do they transform matter.  Generally speaking, they are processes involved with analysis, diagnosis, treatment or some type of function. Notable examples are those nanoparticles involved in drug delivery. Even though the particles behave differently at the nanoscale level, they essentially are not transformed or part of a machine and would thus fall outside patent protection under the rigid Federal Circuit test. Now, there is a least the possibility for these types of inventions to move forward in the process of patentability.

Ultimately, the parties in Bilski did not receive the patent on the specific business method that was applied for; however, the patent world at large was able to avoid the strictures of the rigid, bright-line ‘machine or transformation’ test utilized by the Federal Circuit .  In essence, the fields of nanotechnology and biotechnology research and development dodged a catastrophic bullet. In the coming weeks and months I plan to return to this discussion in relation to emerging technology, especially after the PTO, practitioners, judges, and legislators have had time to digest the nuances of this landmark decision.



It is clear that the time has come to integrate cutting-edge science and the law.  In addition to the policy issues involving individuals, it is important to our nation because we must continue our leading role as the innovators of the world.  Furthermore, there is a tremendous amount of money at stake for our economy.  Historically, the method by which to protect the vast amount of money that is invested and earned from scientific research is patent protection.  That must continue.  However, a possible starting point for compromise is collaboration between scientists who invent a new and useful product, derived from biological material, and those who wish to utilize the technology to further the development of particular areas of science leading to additional inventions.

A prime example of a partnering between two groups of scientists in the realm of nanotechnology and biotechnology is that of the DNA robot.  Researchers from Columbia University, Arizona State University, and Caltech have created a Nanobot that follows a programmable path on a surface patterned with DNA (more commonly referred to as DNA origami). Simultaneously, researchers from New York University, led by Ned Seeman, have combined multiple DNA devices to make an assembly line. The DNA robot picks up gold nanoparticles while navigating along a DNA-labeled surface.  The details were released in the May 13th edition of Nature:

Essentially, scientists are at the beginning stages of creating test-tube factories that have the potential to create self-assembling computers, rare chemical compounds or autonomous medical robots able to embark on specialized missions in the human bloodstream. “[We’re] moving from individual entities that do something interesting to systems of entities working on something with a more complex behavior and function,” says Lloyd Smith, a chemistry professor at the University of Wisconsin-Madison.

The California Institute of Technology has applied for a patent on DNA origami, invented by Professor Rothemund.  NYU owns a patent on nano-robotics as a result of the pioneering research conducted by Professor Seeman.  The collaborative effort of these two groups reflects the benefits that are possible through non-enforcement of patents in the early stages of scientific development.  Furthermore, as a result of the partnering, it would be unnecessary for the government to get involved in the regulation of innovation.  A natural outflow of a collective approach would be the development of self-regulating industry standards to shape and guide the evolution of  the interaction between science and the law.

As technology in the bioscientific realm advances, there is an emerging body of law pertaining to patents on biological material, which focuses squarely on the hotly contested areas of personalized medicine and nanotechnology.  Personalized medicine is the practice of creating therapies for the specific genetic profiles of patients and their diseased cells.  Examples of the nanotechnology involved include cancer treatment, bio sensors, bio markers, bio imaging, and drug delivery systems.  The controversies are beginning to form and the potential for litigation is building.  Are these inventions worthy of patent protection?  What happens to these particles after they perform the specific task they were designed to carry out?  Is it a health issue, environmental issue, both?  These are the types of inquiries I am interested in exploring.  By no means do I purport to have expertise in ANY of the myriad fields I plan to touch on, but I am curious, though, and look forward to initiating a robust dialogue with those who are experts or those who are passionate about the direction of the law in these areas.

With that being said, I would like to begin with a broad and general overview of the current patentability issues.  The first hurdle in the patent process is actually having something that is patentable subject matter.  The nexus of the debate is 35 U.S.C. § 101 which provides:  “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent thereof, subject to the conditions and requirements of this title.”  The statute is inherently ambiguous and has enjoyed broad interpretation, when applied by the courts, to determine if something is actually patentable subject matter.  See, e.g., Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (statutory subject matter “include[s] anything under the sun that is made by man.”).  However, the statute does not afford limitless possibilities and probabilities to the inventors of the world.

There are three specific categories that are off limits to the powers afforded by obtaining a patent:  the laws of nature, physical phenomena, and abstract ideas.  Diamond v. Diehr, 450 U.S. 175, 185 (1981).   The primary reasoning for unpatentability was articulated in Gottschalk v. Benson, 409 U.S. 63, 67 (1972), whereby the Court reasoned that, although these three categories could be discovered, they ultimately “are the basic tools of scientific and technological work.”  The rationale is simple, if these basic building blocks of nature were allowed the protective rights of a patent, specifically the right to exclude others from practicing the inventions or discoveries, the world of research would be drastically encumbered and hindered.  These excluded categories, the basic building blocks, are utilized by scientists, inventors, and theorists to create patentable subject matter.

While the discovery of any of the three excluded categories does not qualify for patentability, the application of them that leads to a new and useful process, machine, manufacture, or composition of matter, may very well lead to a patent, including those that have helped to fuel the explosion of scientific research in biotechnology.  Diehr, 450 U.S. at 187.  Those developments have spawned the creation of personalized medicine.  Science is moving forward and is forcing the law to keep pace.

The paradigm to determine the patentability of nanotechnology related to biological material might be altered in the near future due to the Supreme Court hearing the case of In re Bilski (the discussion of this case and the implications of the opinion has the potential to occupy many future posts).  The Court heard oral arguments on In re Bilski on November 9, 2009, and the forthcoming opinion in that matter will have an impact on the patentability of processes, including those that have helped to fuel the explosion of scientific research in biotechnology.  As a result, the development of personalized medicine hangs in the balance.

In addition to the legal, scientific, and ethical debates, there are the personal policy concerns.  A few worth mentioning are those relating to autonomy, freedom to make decisions about resolving/preventing health issues, the right to feel safe about the treatments we receive, and the list goes on.  The point I am trying to make is that we are on the precipice of a new era with the interaction of nanotechnology, personalized medicine, and the law, and we stand to gain more than we could ever have imagined or we stand to lose more than we ever bargained for.

Personalized Medicine Coalition, _5_5_09.pdf