Wisconsin Public Television University Place Wednesday Nite at the Lab  Victoria Sutton New Systems For Electronic Lab Notebooks  September 14, 2011 UP621    cc >> Tom Zinnen: Welcome, everyone, to Wednesday Nite at the Lab. I'm Tom Zinnen. I work here at the University of Wisconsin Madison Biotechnology Center and also for UW-Extension Cooperative Extension. And on behalf of those folks and our other partners, the Wisconsin Alumni Association, the UW Madison Science Alliance, and Wisconsin Public Television, thanks again for coming to Wednesday Nite at the Lab. We do this every Wednesday night, 50 times a year. Tonight, it's my pleasure to introduce to you Victoria Sutton of the Wisconsin Alumni Research Foundation, more affectionately known as WARF. >> Girl: Daddy, can I tell you something? Why are you just standing there? >> Zinnen: Because I'm doing an introduction. Victoria got her BS, bachelor's degree, in biology from Western Michigan University and a PhD in cellular and molecular biology here at UW Madison. Her professional experience includes a federal internship with the FDA. She's also an intellectual property associate, or she's currently an intellectual property associate for WARF and she's a registered patent agent. 

Her responsibilities at WARF include the protection of inventions and fields using agriculture, bacteriology, biochemistry, chemistry, environmental science, food science, health and nutrition, and human and veterinary pharmaceuticals. WARF has been the designated patent management organization here at the University of Wisconsin since 1925. Its mission is to promote scientific research at the UW by protecting patentable inventions, licensing those inventions for development and commercialization, and investing licensing revenue to fund further scientific investigation. It is a remarkable age of excellence for this university. When I finished my PhD here in 1985 and started my postdoc, I went from working at a university and for a lab that didn't care much about intellectual property and went to a private enterprise. One of the first things I did is train new people on how to keep a really good lab notebook that would stand up in patent court. That's why when this new electronic stuff came out I was interested in two reasons. One is the intellectual property aspects of it. And the other is the potential for expanding public participation in the research mission in the university. So I'm looking forward to tonight's presentation. 

If I can get my two kids out of here, that will be helpful. And please join me in welcoming Victoria to Wednesday Nite at the Lab. [APPLAUSE] >> Victoria Sutton: Thank you, Tom. Am I audible? Reasonably? Is that a little better? Okay. So my goal today is to talk with you about lab notebooks, what it means to have a good lab notebook, why it's important to have a good lab notebook, and then talk with you about some of the latest trends in research record keeping, and that includes, as Tom mentioned, electronic laboratory notebooks. And I want to talk with you about the promise or the potential promise that they hold and also some of the challenges that we see in considering them for a campus like UW. So as Tom said, I'm an intellectual property associate at WARF. I'm a patent agent and my job is to bring in inventions and assess them for patentability, and if we decide to move ahead with an invention, to then work on getting it patented and helping my licensing colleagues get it out there in the world where it can make a difference. So as you'll see in here, I take some time to talk a little bit about inventorship and how record keeping relates to inventorship because that's certainly key here and may be key for you also, whether you are an inventor in your garage, you work in a lab, you are just interested in these matters, or just curious about what it is that people do with lab notebooks all the time, hopefully. Let's see, okay, so why are lab notebooks important? First of all, for now, and not for very long apparently, the US is a first-to-invent country. 

That means that patent law is about to change. Reform bill is about to be enacted and most of the revisions will actually be relevant in about 18 months. So historically and up until 18 months from now, the US is a first-to-invent country. That means the US awards the patent to whomever is the first to invent an invention. Where there is a question because several people invent an invention and go to the patent office at similar times, there's a process through the patent office called interference for sorting out who really was the first to invent and awarding the patent to that person, to that inventor or inventive entity. So that's an important reason to keep a lab notebook. In order to determine whether you were in fact the first to invent an invention, it's going to come down to your record keeping. How good it is, how useful it is, how credible it is, how verifiable it is, and all of that is important for what we do. Your lab notebooks are a permanent record which detail your projects and your inventions. Your records should allow someone else to come in and recreate and trace your work. 

Science is all about reproducibility and that's very important. The better a scientist's records, the better the chances that someone else can come through, repeat what they've done and better learn from the work they've done and the contributions they've made to their field. Your research record should also allow another to conduct additional work to follow up on the work that's been done already without the assistance of the original researcher. This can be particularly important where scientists, of course, are moving on and they  have contributed in many ways to their field, any one of those ways which may be picked up by a subsequent student or postdoc or other scientist. Your research records can provide essential evidence proving what a researcher did and when and why they did that work. This can be critical for inventorship. And I'm going to spend a couple slides in just a minute talking about inventorship. What is an invention, what does it mean to be an inventor, what does inventorship entail, and so forth. It can also be important for a researcher to be able to address questions of scientific integrity or misconduct or to address questions of derivation. Derivation is when a scientist borrows some or all of an invention from another inventor. 

And that's something that the patent office takes a very hard line on, of course as they should. So if you have detailed lab records showing what you did why you did, what the inventive process looked like, you're going to be able to address any questions in case someone else was doing something similar around the same time. So finally, in a detailed lab notebook one can find records of successes and failures and the entire inventive process. Now, scientists never like the failures part, but in my world failures are golden and if somebody can think of an idea, a project, a question, and immediately think of how to address it and when they do it in a very short period of time, it works out just the way they thought, that may be important, it may make a huge contribution to their field, but in it the patent office's eye, it's not inventive. They didn't have to overcome a challenge or a problem and add something beyond what was understood in their field. And that's where failures are golden because if you have a failure in trying to accomplish something, that means that it wasn't so straightforward that just anybody could have done it. You had to be inventive and add something to the project in order to make it work. And that's fantastic. So it's just as important for my world that scientists accurately document their successes as their failures. And again, the inventive process is told in the story you tell as you keep a really good lab notebook. 

And again, what the patent office is looking for is inventions and an inventive processes where the inventor had to contribute something inventive and where the process was not entirely predictable. Okay, what's important about when you invent? First of all, conception. Conception is when you have a definite and permanent idea of the operable invention, and each of those pieces of that definition are important. When you have a wish for an invention, you do not have conception. When you have a partially working idea but a couple of elements aren't going to work out, that is not conception. It's when you've worked through the elements enough that you know what your invention needs to be and how it needs to work to make it operable. That's what you have conception. And conception is key for figuring out who made an inventive contribution. >> Is the word conception? >> Yep. Like conception of the idea in its complete form. 

So the second step that's important is what we call reduction to practice. Now reduction to practice means the making and testing of something. That's when reduction to practice is what we call actual. In most endeavors, certainly in my field of biology, almost everything you do is fairly unpredictable. You actually have to make it and test it to show it was going to do what you hoped it would, what you thought it would. But in some areas, if you design an inventive ladder, for example, you may be able to tell from the property of the materials themselves that you've designed it with that it's going to work. You may not actually have to make it and test it to show that you've got a great invention here. But in most fields actual reduction to practice is really important for the patent office to know that you've made a really valuable contribution through what your invention can do and what it brings to the field. And then finally, diligence is a really key issue. Diligence means that you're not abandoning something or letting it go. 

In the patent office's eyes if you abandon something, then you don't get credit for the earlier work. If you just let something go, you're not making diligent progress toward an invention that you can tell the world about in a patent application, thereby benefiting society and other scientists. So not abandoning your invention is really important. And that doesn't have to mean you work on it every minute, every week, every month, just a normal process as you gradually move forward. There can be hiccups, just not abandonment. And again, a really good lab notebook is going to help you demonstrate that you were diligent in moving through these steps for your benefit and society's. So inventorship is a legal determination of who made an inventive contribution to at least one claim in a patent application. So what is a claim? A claim after everything, all the supporting, informative stuff in a patent application, a claim is the bit at the end that serves as a legal definition of what the invention is. And when the patent office issues a patent, this is a legal definition that they are agreeing to uphold on your behalf in court, if it comes to that, against anyone who steps on your toes by using your invention as defined in the claim. So if an inventor is someone who makes an inventive contribution to at least one of the legal definitions of the invention as approved by the patent office. 

So that's what you're looking for when you try to assess inventorship, looking in someone's lab notebooks to assess their contribution. Inventorship can take a lot of forms. It can have a lot of inventors, one inventor, one inventor can have started and another one finished the job. They can work in collaboration. It can take a lot of different forms. All of those are okay as long as each inventor made an inventive contribution. And as I said before, inventorship is a strictly legal issue. Unlike authorship in papers and acknowledgments in other ways, inventorship is absolutely nonflexible. You have to meet the legal threshold in order to be listed on a patent as an inventor. Otherwise, listing too many people, too few people, or the wrong people can invalid date the patent and that does no one any good. 

So inventorship is something we assess. This may seem a little harsh. The nice news, actually, is that it's fairly black and white. So it's a nice kind of relaxing thing. You either do or don't meet the inventive threshold. And we'll talk in a few minutes about what kinds of contributions people might make without actually being inventors. So a person is not an inventor, even if they work on a project, if they merely suggested an idea or made a wish but didn't know how to carry it out. If they simply followed instructions. If a professor comes for a graduate student with a fantastic idea that's fully fleshed out, the graduate student follows instructions and it all works, the professor is the only person who made an inventive contribution in that project, even though the graduate student did all the work. But if the graduate student hits a hiccup and has to solve a technological hurdle in order to make the invention work, then that kind of contribution is likely to make them an inventor. 

So it's something that we assess. A person is not an inventor if they can explain how or why an invention works where no else could. That's a huge contribution but it is not an inventive contribution. A person is also not an inventor if they adopt information or derive it from another. And we talked about that a little bit before. Research records should include all of these elements. What a person is doing and in great detail. We're going to talk more about the types of things that should be included and how they should be included in a paper lab notebook. Why it's being done. That's very important for understanding the inventive process. 

If you identify a hurdle and you have an idea how to solve that problem, it's important to write it in there. You may be wrong, that's okay. Again, failures help demonstrate that what you've done in the end is inventive, but writing down your process is very important. Who did the work. Again, this can be helpful for tracing inventorship and correctly recognizing when you're looking back on it who made contributions in what ways. When this work was done. Dating the record is very, very important in order for it to stand up in court, and we're going to talk more about signing, dating, and witnessing recommendations later. What the results were in as much detail as possible. Again, all of this is for verifying and lending credibility to the record. The conclusions that are reached, very important again for understanding the inventive process and also helpful for the researcher or inventor as they move forward and try to look back and remember where they were at the end of a specific experiment. 

And then finally future plans. Where do you want to go from here? What are your ideas? This is going to help with the whole assessment. It is important though, in both the conclusions and the future plans, the researchers try to be as objective and factual as possible. Being melodramatic can be more damaging than helpful. If, for example, a frustrated person writes this is never going to work, I'm never doing this again, I'm going home, that's really not very helpful for establishing diligence. But if what they're writing is I'm frustrated, I think the problem might stem from this thing, we're going to continue to work on that next, that's a really helpful kind of conclusion and suggestion of future work. Okay, details to record. All of these things. I'm not going to read them all off. But in as much detail as possible. 

Everything about what a researcher did, how they did it, what they used, what they found, and actually placing that all in the record is very important. And that includes original raw data from things like computer printouts from instruments, drawings that they made, flow charts, chemical structures, whatever. It can be very helpful for researchers to streamline their process because this is starting, I'm sure, like a lot of writing and it can be. If they start using streamlining approaches like a master protocol book. This might mean that they take a method that they want to use, they give it a name, and they put it in a three-ring binder for easy access. Then they take a photo copy of that and they put it in their lab notebook so that there's a credible account of that protocol at one time. And then after that they can say I followed protocol 13A exactly as stated and proceed with their research. It can save a lot of time. A list of abbreviations can be important to make sure everybody is thinking about the same thing. And a three-ring binder for any output that's voluminous or difficult to take care of in a lab notebook. 

But again it needs to be heavily cross-referenced or it will not be part of the credible documentation of their work. So a very important thing for inventors and researchers to consider, and again this will change soon, some of it will stay the same, some of it will change, but at this time when you disclose can impact your rights, and actually that will continue to be true. When you disclose your invention to the public will continue to impact what rights you have in the US and in foreign jurisdictions for patent protection. So that makes when you tell the public about your invention very important. Public disclosures can include poster presentations, departmental seminars, televised presentations, using your invention at a farmers market. Anything that tells the world about your invention sets a clock in the US of a year in which you can file for a patent application. In most of the rest of the world it shuts down your patentability options. Some places allow a small grace period, but in most of the world there is no grace period. As soon as you tell the world, you can no longer patent it. So researchers should keep in mind who they're telling when, and under what conditions. 

So how should researchers be actually attaching their data in their paper lab notebooks? Well, first of all, in a single layer, and it should be taped down, preferably with double-sided tape, single-sided tape will work too. And before they tape it down, if it's single-sided tape, they need to initial on two sides and date on two sides right across the edges so that the courts can come back and see what was originally put in there is the same thing that's still in there. It hasn't been moved, changed, or replaced. And that's going to help establish credibility for whatever they put in there. Of course that means it needs to be in a single layer or else you don't have that kind of confirmation. Entries should be entered on the same date of the event preferably. That doesn't always work out, practically speaking, but it is the ideal. Entries should be signed with a full signature and dated. Again, all of this helps establish the credibility of the record for future use for any questions that are asked for which the lab notebook can be helpful evidence. And, ideally, it should be witnessed and dated. 

Not very many researchers do this. It can be a complicated and time-consuming thing but it's very important. There are court cases in which inventors were not allowed to get a patent because they did not have witnessed documentation, their lab notebooks were not witnessed. They were signed, they were dated, but they were not witnessed, and the courts threw them out as evidence of inventorship. So it can be a very important thing. Ideally, witnesses would witness within, say, a week of the work to make sure that, chronologically speaking, the witnessing and the work itself are close in time. Oops, I went backwards. Okay, so what should lab notebooks be like? First of all, they should be a permanently bound notebook with numbered pages. That makes them easy to reference to. You certainly don't want three-ring binders or anything where it's too easy to swap pages in and out. 

That's not going to help form a credible record. Ideally, books should be numbered consecutively by the lab or by a single person in the lab assigned with the duty of giving out these lab notebooks so that they can say lab notebook 137 was assigned to so and so and that's, in fact, where we found the data in question. There should be a detailed table of contents. All entries should be consecutive. If there's any unused portions, they should be X-ed out. Again, this all helps us establish the credibility and explains what the researcher did and how they developed their record. It should be created using waterproof permanent ink, and of course it should be legible. There should be no erasures or obliterating. In other words, completely crossing something out. If a correction has to be made, it should be lined out, signed and dated, and an explanation added about what had to change and why. 

Again, this helps us make the correction as credible as the original entry. And that can be really important. Corrections, oh, I said all that. And then finally, each lab should have a disaster recovery plan. Hopefully this is going to address everything from what happens with a researcher's electronic files on their computers in which they took data, analyzed it, made graphs, made figures, whatever they did, but also the lab notebooks themselves. Some thing, some microfiching is possible, Xeroxing in some way to have a disaster recovery plan can be helpful for those rare cases where it actually matters. Okay, actually one last suggestion, whoops, there. Research notebooks should be stored some place safe. Sorry, I'm not to this slide yet, I just couldn't get back. Research notebooks should be stored some place safe, for example, in a lab drawer. 

Studies have shown when fires rage through labs, a lot of what survives is the stuff in the lab drawers. So if researchers do nothing else but put their lab notebooks in a drawer every night, they're more likely to have it at the end of their research. So small things can make a big difference. Okay, so I want to talk with you a little bit about the challenges of electronic records. Whether or not paper records are also being used. And this, I think, is a really interesting quote out of Nature journal. And it points out that digital information is really quite fragile. If we can't read digital files from 10 years ago in comparison with our ability to read materials from over 2,000 years ago. And it's a really important consideration when you consider electronic records and what we might do with them. There are a lot of challenges to overcome, and adopting electronic records means doing so in a really careful and deliberate way that's going to make sure that electronic records are, in fact, better for us overall than the paper records that they may replace or supplement. 

I'm part of a committee of DoIT personnel and me, as the WARF representative, that formed a committee to investigate whether electronic laboratory notebooks, or ELNs, would be useful on this campus. At present, we are unaware of any major university offering electronic laboratory notebooks across the entire campus. There are examples of small colleges doing it, there are examples of departments, labs, even schools within a large university doing it, but there aren't whole enterprise-wide campus offerings. So we're either on the front edge of something very exciting or that's an indication that maybe the products available aren't ready yet for the challenges of a major research campus. They are in wide use in companies but those are different challenges, different situations. So we began our process by interviewing researchers across campus in many different disciplines to gauge their interest and their need for, their perceived need for electronic laboratory notebooks and to also understand what their current practices are. Did they already have electronic laboratory notebooks? Did they use electronic records? Were they frustrated with what they have available? We've certainly found that the researchers recognized a lot of challenges of paper notebooks. One of the widest or one of the most widespread comes from the fact that increasingly researchers are doing things in digital form. Their analyses are in digital form, increasingly their raw data is in digital form, and almost everything they do for presenting their work is, of course, in digital. And increasingly that becomes difficult to manage when you're having to somehow take that out of an electronic environment and represent that appropriately in a paper lab notebook to create a credible and permanent record. 

And so we got a lot of feedback about that. Other things we learned. Students may be keeping their records, some on their laptops, some on a lab computer, some here, some there, some not backed up. The organization of different electronic files which were already hard to represent in paper form are also hard to keep track of back up and protect. And that's an additional problem. So what are some of the benefits of an electronic laboratory notebook? Theoretically, electronic laboratory notebooks should be searchable which means that if you want to know if a student has ever done an experiment that used a specific reagent, you can search for it. And every experiment they've ever done with it should pop up. That can be really helpful when you're trying to follow through on specific results, find something you sort of half remember, or, for professors, find something after the student is gone. And those are all things we heard was a really important need among researchers today. Let's see, one of the most exciting things that electronic laboratory notebooks offer is the potential for sharing records. 

So let's say that there is a three-lab collaboration happening. Maybe where one researcher is putting together the DNA for a protein that's needed, another researcher is purifying the protein, and a third researcher measures activity of the protein. If all of those labs were using electronic laboratory notebooks, they could connect to each other specific pages about these experiments and have a fairly seamless process for collaborating together. There's also a lot of potential, as we'll talk about, for that kind of collaboration to spread farther out than that. Farther out than just research universities. We identified a lot of functional needs for electronic laboratory notebooks, what researchers would need to have in place in order for these to be really great things, and all of those helped form our request among current manufacturers for what they could do and how they felt they could meet our needs and a request for proposal that we put through the state process. We got responses back from a number of manufacturers and those were assessed. We did some demonstrations of a few existing products before researchers on campus, again to get their assessment of the products and whether or not they felt they'd meet their needs. And soon we plan to begin, we hope to begin, plan to begin, a campus-wide pilot trial of one or two of the products. That's not yet finalized so I can't be very specific about it, but we hope to enroll scientists from a huge range of specialties. 

We would like to have a single product tried by physicians, crop scientists, plasma physicists, engineers, people working in a microbiology lab, chemists, really explore various capabilities of a product and see whether any single product is great for some areas, or even better yet, great for all of campus. It also needs to meet all of our technical needs including things like will it work with the university's identity management systems, is it secure enough, can we figure out how to handle storage and server capacity, and so forth. And so the DoIT professionals that I work with are doing a wonderful job of exploring all of these issues and making sure that as we learn about these products we're going to be in a great position to make a really informed decision. So that campus wide pilot trial should happen this fall, hopefully actually very soon, and then we'll know far more about its usefulness for this specific campus. So I talked a little bit about some of the potential we identified by talking with researchers about electronic laboratory notebooks, but I wanted to expand on that a little bit about the promise that electronic laboratory notebooks hopefully hold for us, if not this year, some day in the future. Electronic laboratory notebooks should facilitate sharing and review of research records. This can, again, allow collaborators access to select records for which access can streamline and enhance collaboration. It can also help supervisors to review the data of their students, postdocs, researchers and to provide feedback and mentoring, a better overall process as students learn how to be great scientists in the lab. Electronic laboratory notebooks can provide a way to better organize electronic records. If you have a number of records, let's say three raw data files, an analysis file, a graph, and some means for presenting all of that, all related to a single experiment, right now it's complicated to record and acknowledge all of those pieces. 

An electronic laboratory notebook may make all of that much more seamless, understandable, and mean that less is lost, more is learn. Electronic laboratory notebooks have the potential to better archive records and files for the similar reason. Once you can find them, it's going to be a whole lot better to back them up and protect them. Electronic laboratory notebooks can offer built in protection for data and identity management, certainly in the forms that we're looking for this kind of campus roll out. And there are federal and institution guidelines that help guide our choices here, make sure that we're going to end up with a system for managing those that is very robust and is going to make sure that we understand and can say before a judge, yes, this researcher is the person who input this. It was subsequently changed or corrected or whatever in this way on this time and this date and here's the old and here's the new version. Or whatever we need to say to explain the research record and establish its credibility for whatever purpose we need it to be credible. And electronic laboratory notebooks can provide a great method for recording changes in files and records, actually I just said that, with versioning where we have all of the copies. It tells a better story. One very exciting thing about the potential for how this could impact, Tom asked me how this might impact processes that reach beyond the campus and its collaborations. 

One of the exciting things that can happen is that through better management of electronic records it may be possible for researchers to tap into, they're getting data from multiple sources, for example, at present it may be very complicated to track that, search that and utilize all that information in a really efficient way. There is the potential for electronic laboratory notebooks to facilitate all of that by streamlining it, making sure nothing is lost, that it's easier to track things, record things, and note their relevance and, again, allow collaborations to take place. Where we have growers testing crops that were bred at the UW, there may be some mechanisms possible through this that are complicated to achieve now for sharing information and getting input from all the relevant experts who can contribute to an idea. So those are all exciting possibilities. And actually, that's the end of my presentation. I'll be happy to take some questions in just a minute. [APPLAUSE]