Issues with the “Ebola patent”

A post from our student blogger Catie

Recently, a U.S. patent was presented as evidence online to support a theory that the U.S. government created the Ebola virus. Considering it was a patent, I had to check it out for myself! If you google ‘google patents’, it will take you to a patent database provided by Google where you can perform your own patent search on any subject you can imagine. You can also see the ‘Ebola patent’ by googling US20120251502 A1 or searching ‘Ebola virus’ in Google patents.

After taking a quick look at the patent, I noticed a few problems with it. Firstly, this is not a granted patent. If you look at the gray box at the top of the screen, you will see that under ‘Publication Type’, it is listed as ‘Application’. This means that this is simply a published patent application, which is what happens to all patent applications that are submitted to the USPTO. For reference, do a Google patent search of patent 5,000,000. This is a patented invention, and under ‘Publication Type’, it says ‘Granted’. Next, do a Google patent search of ‘godly powers’. This is a completely ludicrous patent application, but it is indeed still published. This goes to show that the Ebola virus has not been patented, and its publication status does not necessarily speak to its legitimacy.

As I continued to go through the patent, it raised some red flags for me that all descriptions of the invention and even the claimset claims ‘an isolated human Ebola virus’. Natural phenomena are not patentable! An invention must be a new, useful object or method that was created by humans for the benefit of others and must be capable of being reproduced by a person skilled in the art of the invention. On public PAIR, which is another patent database, I looked at the office actions that have been sent regarding this patent up to the present day, and it actually was rejected on a 35 U.S.C. section 112 violation. This means that the examiner did not find the application to describe the invention in clear enough terms for it to be reproduced or utilized by the public.

I was incredibly surprised to find that the application did not also have a 35 U.S.C. section 101 violation in that ‘an isolated virus’ does not meet the criteria for a useful invention. However, in the discussions of this patent application on Google patents, it was pointed out that the isolated virus in which they are claiming is some sort of weakened version of the virus that was likely isolated for research purposes. If that is the case, then the ‘patentable subject matter’ issue may be slightly less of a problem. Nonetheless, we have been learning that in patent application drafting, it is best to be upfront about why the invention at hand is new and useful so that it may be absolutely clear to anyone who reads it that it is indeed deserving of a patent! This patent application simply describes the physical characteristics of the isolated human Ebola virus, with no description of how to synthesize or use it! Based on the other office actions that have been made in the case of this patent application, I think the inventors still have a long road ahead of them before they can hope to have the patent granted. So no worries, everyone: no one yet owns the exclusive rights to Ebola!

Getting down to business

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A post from our student blogger Roberto

The past few weeks have blown by like a finely crafted Italian sports car on the Nürburgring.  Fall break is finally upon us and we have taken our first midterms.  We have also all received our Patent Bar review kits from the Practising Law Institute (PLI).  These robust study aids were provided to us by Notre Dame to help us prepare for the rigorous Patent Bar exam that awaits our imminent arrival.  For anyone considering a career as a patent agent, you should know that the Patent Bar is one of the most difficult standardized tests with a pass rate of 46.8% in 2013.  It is also one of the least taken with only 2766 exams being taken in 2013.  With only around 40,000 active licensed members nationally, patent agents are always in demand.

One of the nicest things about Notre Dame is how much is always going on at school.  During bootcamp we were lucky enough to have a guest speaker come in and give an almost day long presentation on intellectual property.  The presentation was open to the entire campus and surprisingly, since it was the week before the start of classes, many other students took advantage of the opportunity as well.  During the question and answer session one of the students stated that he was an aspiring young entrepreneur.  After the lecture was over and we were all walking out I made my way over to talk to him.  I just wanted to let him know that I had been through some of the entrepreneurship process before, both with my family business and with a startup business I had explored as an undergraduate student, and that I would love to talk with him about my experiences.  We ended up exchanging phone numbers and have met for lunch a few times since.

A few weeks ago I came up with a pretty cool business idea while sitting in class.  I knew right away that my new friend would be the perfect person to start this endeavor with me.  I spent a few days perfecting the idea in my head and met with him later that week.  After I shared my vision with him he was sold.  We decided to enter the McCloskey business plan competition here at Notre Dame together and have begun the process of assembling a team comprised of students from a wide array of backgrounds.  While it is still early on in the process I can say without a doubt that it has been a very rewarding experience.  Even though I cannot guarantee our venture will work out, I am so thankful that Notre Dame has made it possible for us to give it a shot.

I could not publish this post without mentioning the incredible game Notre Dame played against Stanford a few weeks ago.  Despite the rainy and chilly conditions throughout the entire game the sellout crowd stuck it out.  It was an incredibly close game with tremendous momentum swings between the two legendary foes.  The adverse conditions only served to enliven the crowd and strengthen their resolve as the Irish beat the Cardinal with a last second touchdown right in front of the student section.  Long after my days on campus are over I know that memory will stick with me and remind me that when the going gets tough, it’s time to get tougher.

Have you thanked a scientist or engineer today?

A post from our student blogger Megan

Every year the MSPL students get the distinct honor of working with Notre Dame research scientists and professors who have developed a novel method or tangible item that is in need of patent protection.  The students work hand-in-hand with these Notre Dame faculty inventors to formulate a patent application on the inventor’s idea.  The process is a ten month learning experience and involves understanding the inventor’s concept and then writing a claim set and ultimately developing a complete patent application with respect to the invention.  This process, while it appears quite succinct, requires lots of interaction and devotion of time to interviews with incredibly talented inventors.

The class that involves this thesis project is called “Capstone.”  The class itself meets one to two times per week, but it is the work that goes on outside the classroom that truly shapes the Capstone experience.  In general, my Capstone thesis project is a novel combination of washing, staining, and imaging a sample of tumor tissue all in one tiny device, resulting in a three-dimensional view of the tumor and its entire environment.  “So what?”  You ask. Well, this isn’t any regular biochemistry lab function; in fact, this is a genius collaboration with far-reaching diagnostic effects fabricated by three separate labs here on Notre Dame’s campus.

You see, up until now, in order to determine whether a patient had breast cancer or not, a fine needle biopsy was taken from the patient and then sliced into hundreds of small two-dimensional pieces.  These slices were each painstakingly mounted on separate slides, stained, and imaged under a microscope.  If you wanted an idea of what the entire tissue environment—and not just a sliver of the area—looked like, an extra step was added to this already complex method:  examiners would feed the microscope images into a computer program and attempt to piece the pictures back together to get some sort of image of the tumor and its surrounding area.  My capstone invention is groundbreaking because it proposes to keep the tissue surrounding the tumor completely intact.  This is important because it will lead to more accurate and informed cancer diagnoses.  Currently, pathologists make cancer treatment recommendations based on very small, two-dimensional biopsy samples, or the pieced-together computer generated methods.

To arrive at this understanding I have had the opportunity to get to know four inventors, invade each of their labs, and meet with them countless hours to discuss their invention.  Perhaps the most surprising thing about conversing with each one of them is their level of enthusiasm for what they have created.  You might be under the misconception that scientists and engineers are a little boring.  My four inventors are just the opposite.  Their faces each light up with excitement when they get the chance to explain why this invention is so important.  And just as they beam with passion over what they’ve discovered, they just as quickly bubble over with delight when they get to show you how they came up with the idea.

Because of my inventors’ fervor for discovery, my days are full of interest and purpose.  Take some time today to thank the scientists, engineers, researchers, educators, and anyone else you know who has worked tirelessly and thanklessly on new ideas that ultimately heal our society or just plain make our quality of life better.  They deserve some praise—so insist on it—even though they probably won’t want to take the credit.

Who’s on first?

A post from our student blogger Catie

As we have discussed before, patents grant their inventors exclusionary rights to the particular idea at hand. Think for a minute about all of the inventions in the world. Have you ever had a light bulb moment where you think of an idea and then joke around with your friends about how you should patent it? Have you ever considered that another person somewhere in the world may have had the same idea? With these thoughts in mind, consider how crazy the patenting process can be when multiple inventors are trying to patent the same invention! This happens quite often, particularly in the fields of science and technology where inventors are racing to find a viable method for treating cancer or to create the next big breakthrough in computerized widgets, respectively. Sometimes it really does come down to a race between inventors to see who is granted the patent!

There can only be one patent per invention, so you may be wondering at this point: who gets the patent? All countries follow a First-to-File (FTF) system to delegate who gets those rights. This means that whoever is first to file a patent application for the invention gains the exclusionary protection of this idea. This system has not been around very long in the USPTO; as a matter of fact, we were the last country in the world to adopt this system! The First-to-File system was enacted in the United States in March of 2013, along with tons of other new rules that were introduced as part of the America Invents Act (AIA). Basically, all that you need to know about AIA is that it enacted many new ‘rules’ that were basically just updated forms of patent rules and regulations that were already in place. Therefore, after March 2013, the first inventor to file a patent application of a particular invention with the USPTO was exclusively given the right to the grant of a patent in the US, regardless of whether or not that inventor was the first to actually invent it. Also, keep in mind that this does not guarantee that the invention will definitely be granted a patent or that it will be commercially successful. First-to-File simply grants the inventor the right to claim the invention with the potential to be patented!

Before the US utilized the First-to-File system, we had what was called the First-to-Invent (FTI) system. This system granted the protection of an invention to the inventor who could produce proof that he or she was the first person to conceive the idea and reduce it to practice. This demonstrates the importance of the inventor to keep a detailed lab notebook of ideas and the dates on which they occurred or were discussed. It is fairly easy to see how the First-to-Invent system could potentially be much messier than the First-to-File system. Providing legitimate proof that someone was the first person to conceive an idea and produce the invention can be very difficult and runs the risk of being based on arguments of personal accounts or biased evidence. If we are dealing with an invention that is pending a race between inventors to obtain a patent, then this whole situation can turn into a “who’s on first” argument in litigation of “who invented first”. The First-to-File system foregoes the arguments and confusion that must be delegated by the USPTO of who invented first and simply grants those rights to whomever was first to file their patent application. I think we can all agree that this was a smart move by the USPTO!

The road ahead

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A post from our student blogger Roberto

The past few weeks of classes have taught us a ton of information about drafting patents.  We have drafted a picture claim for a patent, which describes an invention in all of its gory detail, and a broad claim, which describes an invention in as wide of terms as possible, in our patent application drafting class.  Writing claims has not been easy for me.  In many ways, it is similar to writing proofs of mathematical theorems and to say proofs were my least favorite of my mathematical career would be an understatement.  However, after all the practice I think I am starting to get the hang of writing claims and I am starting to really appreciate them for the art form they are.  Thankfully, we’ve had some practice writing them and will certainly have many more opportunities to build our skills in writing them.  In our other classes we have searched national and worldwide patent databases and we have learned many of the laws and regulations involved with patent work.

In our Capstone projects we have all met many times with our inventors and are beginning to understand the technologies we are tasked with protecting.  The next step for us is to game plan and figure out how we will craft a patent to protect it.  As a kid I used to love board games like Risk and Monopoly.  One of the reasons I loved those games, aside from the fact that I usually beat my siblings, was that it always took a certain amount of strategic planning to completely annihilate your opponent.  So far that is how I have approached my Capstone project.

After every meeting with my inventor I try to condense my notes into my battle plan and attack strategy.  I have quickly learned that this entire process is extremely fluid and dynamic and I constantly find myself revising my plan and realizing things I never saw before.  I am so thankful to have this opportunity in the MSPL because I know it will pay dividends many times over in the real world.

After a late night of studying I took this picture of the beautiful Basilica of the Sacred Heart nestled in the heart of campus.  Oddly enough when I was walking around that night I had no intention of taking any pictures but when I saw this awesome sight I couldn’t help but take a quick photo.   It got me thinking about how far we’ve come these past few weeks in the MSPL and of our journey ahead.  As the leaves change and the winds chill we will be busy preparing for the moment when those bells toll for the last time as we leave this campus and head out into the great unknown.

The schedule of a MSPL’er

A post from our student blogger Catie

One year ago as a senior, one of the biggest mysteries to me was how the difficulty of graduate school compares to undergrad. As I was offered interviews to graduate school programs, I had the opportunity to speak with veteran grad students who could only tell me that “Grad school is harder than undergrad, but in a different way”. Although that statement is incredibly vague, I’ve come to learn in the last month and a half that this is very true, so let me try to shed some light on the weekly life of an MSPL student!

The fall semester schedule consists of four patent law courses, two technical electives, and at least one capstone project that is unique to each MSPL student. Each of the four patent law classes meets once a week for about two hours and focuses on one particular aspect of what a patent agent does (i.e. writing claims, performing patent searches, drafting a patent application, and learning the rules that govern patent law). There is moderate reading required for preparation of each class, but most time consumed for these courses is dominated by the (usually) weekly homework assignments. This program is wonderful because instead of just learning about the practices of patent law, we are thrown into it so that we learn by doing! The patent law homework assignments may take some quality time to complete, but it’s essentially practicing for our future career.

Any MSPL student who holds a degree below a Ph.D. must also take two technical electives of their choice from their previous field of focus. My degree is a Bachelor’s in Biology-Genetics, so I am taking two graduate-level biology courses: Advanced Cell Biology and Molecular Biology. These are your typical Monday/Wednesday/Friday or Tuesday/Thursday classes. Although these courses are electives, it must be kept in mind that we’re still talking about Notre Dame graduate-level science courses; so it’s no joke! Homework and reading for the electives probably require the same (if not a little more) time commitment as the patent law homework. I personally think that one of the most challenging aspects of the MSPL program is balancing your time between patent law work and then changing gears to return to the mindset of analyzing scientific literature and their concepts. Nonetheless, these courses supplement the technical knowledge necessary to comprehend your potential clients’ inventions! Also, no worries: all ND professors that I have encountered so far are incredibly friendly and helpful, and they genuinely want to help you however possible if you begin to struggle.

Okay, so those are the de facto courses during the week! Other responsibilities for the week that may not be regularly scheduled consist of the capstone project and Lunch-and-Learns. Each MSPL student has an individual capstone project wherein they are working one-on-one with an inventor here on Notre Dame’s campus to draft a patent application for that inventor’s idea. This is our first real-life experience in performing patent law work. Also, any MSPL student who holds a Ph.D. (and subsequently does not need to take electives) will take on two capstone projects. Capstone projects span the entire school year, and they will occupy variable amounts of time outside of class. Most of the capstone-related work is integrated into the patent law courses, but it is the student’s responsibility to schedule meetings with the inventor(s) to discuss the related invention(s) outside of class. For my capstone project, I occasionally meet with my inventor to discuss the invention and solidify my understanding of the technology behind it, as well as attend the weekly lab meetings held by my inventor. It’s a really exciting experience, and I am personally grateful to have the opportunity to do guided patent application drafting before I graduate and do it on my own in the work force!

Finally, we have Lunch-and-Learns, which occur on football Fridays (the Fridays of ND home football games). On these days, a guest speaker from a law firm or another patent law-related corporation visits campus to speak to us about patent law careers. They generally give a presentation that provides an overview of what they do, and we are offered the chance to informally have discussions with them while eating pizza! It’s a fun experience while also providing the MSPL students a great networking opportunity with potential employers!

To round out this post, I want to put it out there that I do actually have free time as an MSPL student! Although, due to the class schedule and the weekly deadlines for homework submission online, I am consistently busy with homework. There is no point in time where I will ever say ‘I have nothing to do right now’, because there will always be something. Like all students are told: it’s all about time management. I may be perpetually working towards due dates, but that doesn’t mean that I am perpetually swamped with work. The MSPL’ers go to football games, occasionally get together at Fiddler’s Hearth on Monday evenings, and leave town on the weekends if they want. Graduate school is hard work, but we still have time to relax and take care of ourselves, too! Like always, if you have any other questions about the life of an MSPL student, feel free to ask!

 

The search is on

A post from our student blogger Megan

You probably haven’t thought about how many patents there are floating around out there but in all honesty, there is virtually a whole sea of them.  Patents and published patent applications are considered “prior art,” or all the information that is already available to the public that may impact the uniqueness of a prospective patent.  Prior art plays a large role in whether someone is entitled to a patent and it must be thoroughly vetted before a patent can ever be granted.  There is, however, a lot of it to wade through.  The United States Patent and Trademark Office (USPTO) granted a total of 302,948 patents last year—an all-time high.  But the United States government has been awarding patents since 1790 when Samuel Hopkins received the first grant on potash, a component used to make fertilizer.  Currently, the USPTO is issuing patents in the 8,000,000 range.  However, the USPTO did not start counting patents until July 13, 1836.  This means that there are 9,957 more patents that need to be accounted for that were issued before the USPTO started keeping records.

United States patents are only a portion of the patents that exist worldwide, though.  Espacenet, a website generated by the European Patent Office (EPO), boasts that you can research their databases for over 80,000,000 patent document records kept since 1836.  Additionally, the World Intellectual Property Organization (WIPO), offers Patentscope, an even more comprehensive search database that covers patent documents from ninety countries.  Granted, these documents are mostly patent applications, and you must note that patents have expiration dates, so you can bet that the majority of the patents you encounter on these databases are likely out of date.  But all of these documents represent ideas that someone thought important enough to request legal patent protection.  Furthermore, they are important to anyone who seeks patent protection due to the laws that prospective applicants must abide by.

Title 35 of the United States Code Section 102(a) states that, among other things, a person may not be entitled to a patent if the invention was “patented [or] described in a printed publication…” This means that if your inventive concept has already been “anticipated,” or previously patented or published in a patent application anywhere in the world, you cannot receive patent protection on that particular invention.  Now, there are exceptions to this rule, but the main focus is to find all of these previously issued patents or publications that may preempt your patent so you can adequately inspect them first.  This process is called patent searching.  While a patent search is not required to file a patent application, it is highly recommended.

For the past six weeks, students in the MSPL program at the University of Notre Dame have been studying prior art exploration methods in their patent searching class.  The sheer number of patents and patent documents seem like a daunting prospect when you are up against a massive sea of prior art awash in the World Wide Web.  There are specific steps to strategically search for relevant patents and publications, though.  The first step to any search is to develop search terms.  Think about the invention and narrow down words that truly describe what it constitutes.  From there, draft a “building block” strategy of synonymous terms.  For example, if the new invention involves a method of three-dimensional cancer diagnosis, your original search terms may include those three words.  Build on these words by choosing synonyms that match these meanings for a more expansive search.  Cancer could be substituted with the word “tumor,” “three-dimensional” could also mean “multidimensional,” and “diagnosis” could be replaced with the word “analysis.”

The next step is to run an actual search on the terms you have developed.  There are a multitude of electronic databases that searchers use to dig up relevant documents.  Besides Espacenet and Patentscope, there are domestic databases that aid in searches as well.  The USPTO website is dedicated to searches for United States patents and applications.  Moreover, Google Patents is a quick, free search engine geared towards the general public.  One can google a patent number, title, or general concept and pull hundreds of patents in seconds from this database.  Once the searcher finds relevant patents and published documents relating to the new inventive concept it is his or her duty to examine these and decipher whether they would prevent the inventor from receiving a patent.

This is a general overview of patent searching—patent searching is not quick or easy, though.  There are professional searchers that have made a career out of searching for prior art patents.  The reward is in crafting a search the edges close to the new technology that you are searching, but is still different enough in scope that the new concept remains novel.  So while the amount of prior patents and documents may be vast, there is no need to fear diving into the prior art pool:  formulate a search strategy and jump in.

What makes an invention patentable?

A post from our student blogger Catie

Before a patent agent can begin drafting a patent application, it is important to determine if the idea is patentable in the first place! The first step in this process is to ask “What constitutes an invention as patentable?” “Is this idea worthwhile in terms of going forward with filing a patent application?” These are pivotally important points to consider, and they should be thoroughly investigated before any application drafting occurs. This is very necessary because it is in the best interest of everyone involved to only draft a patent application of an invention that is indeed patentable. If not, tens of thousands of dollars and countless hours of work are at stake of being lost, because a patent application of an unsuitable invention will be rejected. Not to mention, it would make for a heartbroken inventor and a frustrated patent agent!

There are three main characteristics that determine whether or not an idea is patentable:

Is the invention new? An inventor’s idea must be novel in order to be eligible for a patent. This means that the process, machine, composition of matter, or manufacture to be patented must be the first of its kind and cannot be of content that is already patented, published, or available on the market. For this reason, patent searching is a huge part of what a patent agent’s job entails. The patent agent, with some help and guidance from the inventor, must perform a thorough search of existing literature to determine if the inventor’s idea is original enough to be patented.

Is the invention useful? This may be shocking, but yes, a patentable invention must have a useful result or method to reach a result! It may be the easiest of the three characteristics, as most inventors purely aim to create an invention that benefits consumers, laborers, and the general public. However, it is important to know that one cannot patent natural phenomena, sheer discoveries of nature, or abstract ideas. The invention must have a physical, executable method or use. The literature search that the patent agent performs to determine novelty of the invention may also be helpful for finding supporting information to demonstrate why the new invention may be effective or may resolve a problem posed by previous inventions.

Is the invention non-obvious? This may be the most difficult of the three characteristics, as it is fairly ambiguous and subjective. The term PHOSITA, or ‘Person Having Ordinary Skill In The Art’, is used to explain this characteristic. If a PHOSITA from the field pertaining to the invention would be able to say that the invention in question is an obvious step up or adjustment to what is already known and existing in the field, then it should be deemed obvious and will not be granted a patent. Really, the key is that as long as the invention can be proved to contain a legitimately new result, it should be considered patentable.

Part of the family

stadiumA post from our student blogger Roberto

After the first few weeks of class I have learned so many interesting things.  I have done patent searches in the patent application information retrieval and Google Patent databases, learned parts of the United States Code, examined the manual of patent examining procedure and worked intensely on my capstone project.  Our classes in the MSPL guide us step by step through the entire patent process with each class focused on one particular aspect.  This semester we have a class on patent searching, application drafting, and patent law and prosecution.  This past week we were put directly in the shoes of an everyday patent agent.  We were given an invention disclosure and a few related patents and asked to construct a search report and comment on the patentability of the disclosed invention.  This is just one example of the many real world situations we are put through in the MSPL.

We have also had our first “lunch and learns” for the school year.  These special events are guest lectures where renowned patent professionals come in and share their experiences and knowledge with students.  It has been really helpful to have people come in and tell their story and explain their career paths to us especially as we begin to understand this field and where it may take us.

The most excited thing to happen around campus since my last post was our 31-0 rout of Michigan in the final scheduled meeting between the historic rivals.  Words simply cannot describe how awesome and incredible that experience was.  When I parked my car a few miles from the stadium I could hear the faint fanfare of tailgating in the distance.  As I walked closer I could smell the brats and burgers on the grills and I could hear the vibrant music; the atmosphere was electric.  During the game I struggled through the chants and cheers seemingly every other student had memorized.  However, by the end of the game I think I had most of them down.  I still have a few games to go and can’t wait to experience them with the amazing Notre Dame community.