Medical College of Georgia Office of Technology Transfer Economic

Medical College of Georgia Office of Technology Transfer & Economic Development Inventors Notebook Summer 2006 Inside this issue: We Honor our Inventors Patent Expertise is just around the corner.. REACH wins business competition An Inventors Perspective Ask Dr. G Getting to the Core of the Matter 1 2 We Honor our Inventors by Ronda S. Marcus, Technology Transfer Associate On April 26th, 2006, The Office of Technology Transfer and Economic Development held our first annual MCG Creativity Awards Luncheon. This gave The Medical College of Georgia the opportunity to honor its inventors from FY 2005 and extend its appreciation for all of their hard work and diligence in converting ideas and data into invention disclosures, patents and products. The “inventors” were those individuals who either submitted an invention disclosure or were issued patents in fiscal 2005. Each inventor received an engraved crystal paperweight and an award certificate for their efforts. The award ceremony culminated a banner year for OTTED. The office received 32 invention disclosures, the highest in MCG history. OTTED filed 23 new patent applications, including 11 Provisions, 6 Regular U.S., and 6 foreign (“PCT” and “national”) applications. We also had 9 new patents issued (3 U.S. and 6 foreign). We owe this success to the industry of our inventors. “This luncheon is an annual opportunity for us to celebrate our scientists who work diligently to move knowledge forward,” said Dr. Michael G. Gabridge, associate vice president in the Office of Technology Transfer & Economic Development. The celebration was held on the fifth year anniversary of the biomedical transfer technology office established by Dr. Gabridge and former Vice President for Research Matthew Kluger. 3 4 5 6 Copies of our new electronic newsletter and background information are available at our website: www.mcg.edu/ research/techtransfer Ronda S. Marcus Editor Dr. David H. Pashley, D.M.D., Ph.D. Regents' Professor of Oral Biology & Maxillofacial Pathology receiving his Creativity Award from Dr. Charles Nawrot, Director of Technology Transfer Page 2 Inventors Notebook Patent Expertise is Just Around the Corner...or maybe just across the River! An interview with William F. Smith One of the latest cross-country moves/relocations of families that the CSRA has experienced may prove to be a real asset for local intellectual property practitioners. Our new neighbor in North Augusta is William F. Smith, who has over 30 years of experience in the U.S. Patent and Trademark Office. He started as a Patent Examiner (after earning a degree at Georgia Tech), and ultimately became an Administrative Patent Judge for the Board of Patent Appeals and Interferences. Now retired from the USPTO, he is Of Counsel to the law firm of Dougherty Clements based in Charlotte, NC, and he lectures on IP and patent issues around the country. He was nice enough to visit MCG tech transfer office recently, and we chatted about several issues: Is it true that the U.S. is about to become a “first to file” country as opposed to “first to invent”? There are currently efforts in Congress to “reform” the patent system. The original efforts included many controversial provisions including abolishing the current “first to invent” to a “first to file” system. However, some of the more recently proposed versions of patent reform legislation do not change the current “first to invent” system. Due to the many voices being heard on patent reform it is difficult to say with any degree of certainty which, if any, of the reform provisions will be enacted by Congress. Will this affect our ability to file Provisional Patents? In view of the competing interests and proposals which form the patent reform debate, it is difficult to answer this question. My thoughts at this time are that provisional applications will still be provided for by statute and would be available to establish a “filing date” for whatever subject matter is described therein in the manner of 35 U.S.C. § 112, first paragraph. If the patent system goes to a first to file system, it may be prudent to spend the resources needed to draft a patent application as the research project is progressing so that a decision can be readily made to file the application at the earliest appropriate time as we no would longer have the luxury of evaluating the research results at a later stage of the project to determine if patent coverage is desired. Exactly how are Patent Examiners judged, and how much time can they devote to any single patent application? What can we do to expedite the process? Patent examiners operate under a performance appraisal plan that includes elements such as productivity, docket management, and quality. Every two weeks, patent examin- ers receive a report documenting the amount of work done. The job of a patent examiner is to say the least challenging. Their productivity is measured by counting the number of first actions on the merits and disposals (abandonments, allowances and examiner’s answers) and factoring the time spent during the two week period on examination related activities. Since the examination of a given application takes place over a number of months or years, the examiner’s productivity measurement is an average. Typical times for experienced examiners to examine an application from the time of the first office action to final disposition are in the range of 9-16 hours. If an examiner does not find patentable subject matter in an application during a two week period or receive credit for applications going abandoned or for writing an examiner’s answer, the examiner will need to write more first actions on the merits in order to meet the productivity standard. It should be kept in mind that patent examiners do not receive productivity credit for many of the actions they are responsible for such as responding to amendments where the case is not allowed. At the same time patent examiners are expected to respond to applicant’s responses within certain time frames. Thus, for any given two week period, a patent examiner has to manage their docket to keep the work flow within established timeliness standards as well as meet the productivity standards. Finally, examiners are expected to perform their professional responsibilities in a quality manner. The USPTO has established quality review procedures where the examiner’s in process and final work (Continued on page 6) Summer 2006 Page 3 REACH Wins Business Launch Competition by Deborah Humphrey REACHMD Consult Inc., a freestanding corporation based at MCG Health System, has won $100,000 in funding and $150,000 in in-kind services from the first-ever Georgia Research Alliance/Technology Association of Georgia Business Launch Competition. The prize money will help REACHMD Consult commercialize its telehealth stroke care services. County Hospital (Elberton, GA), and Cobb Memorial Hospital (Royston, Ga.). The REACHMD Consult Inc. Board of Directors is composed of Dr. Hess; Rich Bias, MCG Health, Inc. Senior Vice President of Ambulatory and Network Services; Dr. Mike Gabridge, Associate Vice President for Technology Transfer and Economic Development and Director of Dr. David Hess, Chief of Neurology, presented the Life Sciences Innovation Center at the REACH at the May 18 GRA/TAG awards cere- Medical College of Georgia; and Bill Hamilton, mony on behalf of REACHMD Consult’s foun- MCGHI Administrative Director of the MCG ders. The event was recorded and broadcast by Neuroscience Center. Sandeep Agate, who has Georgia Public Broadcasting as a live web cast vast experience in web-based technology, is that is streamed on www.tagonline.org. CEO of the company. “We will continue to expand REACH in Georgia, and commercialize the program for a national roll out,” Hess said. Once commercialized, the REACH program could become a turnkey system that hospitals across the United States could use to provide expert acute stroke consultation. REACH has received inquiries from Georgia hospitals, and from as far away as New York, Montana, Alaska and Minnesota. REACH (Remote Evaluation of Acute IsCHemic Stroke) was launched in early 2003. Using a web cam and computer database, MCG Health System neurologists provide stroke care to rural hospitals 24/7 by helping medical professionals administer tPA, the clot-busting drug that can mitigate the debilitating effects of a stroke if given within three hours. MCG physicians can actually see patients via a secure feed, evaluate physical signs and symptoms, download information regarding medical history from the participating hospital and send back instructions. Current REACH partners are McDuffie Regional Hospital (Thomson, Ga.), Emanuel County Hospital (Swainsboro, Ga.), Jenkins County Hospital (Millen, Ga.), Wills Memorial Hospital (Washington, Ga.), Washington Regional Medical Center (Sandersville, Ga.), Morgan Memorial Hospital (Madison, Ga.), Jefferson County Hospital (Louisville, Ga.), Elbert Photo Courtesy Phil Jones Page 4 MCG’s Core Laboratories: What’s New? By Abhi Afzalpurkar Inventions at MCG past …. Inventions at MCG Present…. By, David H. Pashley, D.M.D., Ph.D. Regents' Professor of Oral Biology & Maxillofacial Pathology By, Balamural Ambati, M.D. Assistant Professor Department of Ophthalmology In 1977, when I first discovered how well acidic oxalates occluded dentinal tubules in vitro and how effective this could be in treating clinical dentin sensitivity, I was really excited. I asked my chairman if there was anyone to help me write a patent application. His answer was no, there was no one available to do patent searches, market surveys, product notifications, etc. I was on my own! I had to look up patents in that area and adapt my invention to that format. I learned that "patentese" is a strange foreign language. Even after obtaining a patent several years later, no one could help me market my intellectual property. I had a great product that no one knew about. I send many poorly crafted letters to the wrong offices of dozens of companies with no response. More than one-third of the 17 year life of my first patent was wasted because I had no help. Finally, after publishing several papers showing the efficacy of the product, I (and MCG) found an interested company. Mr. Clay Steadman, an MCG attorney helped me negotiate licensing fees, etc. My share of the royalties paid for all of the college expenses of our two boys. Today, the Technology Transfer Center has brought together a talented group that includes an attorney, a scientist, MBAs, marketers, etc. that can save you time, money and grief. My recent experiences with them demonstrated how far MCG Tech Transfer has evolved. They make it easy. Filing invention disclosures and potential patent applications should be an integral component of any faculty member interested in translational research. The process at MCG is coordinated through the OTTED, who have an outstanding group of individuals with the right complement of perspectives - Abhi Afzalpurkar analyzing the science, Ronda Marcus assessing potential markets, Jennifer Valadi handling the legal affairs, and Charles Nawrot & Michael Gabridge providing strategic vision & conceptual direction. Over the last 2 years, I have had the opportunity to work with this group in developing good ideas from the lab into potentially marketable inventions. The process is not onerous, with a minimum of paperwork, and all involved are succinct and helpful at every step of the way. I strongly encourage faculty and staff who feel they have good ideas with potential applications to file an invention disclosure prior to submission to meetings or journal or other public arenas. The Staff of the Office of Technology Transfer & Economic Development President Dan Rahn speaking at the Innovation Celebration, a luncheon honoring our Member Companies, our Sponsors, and many others who have helped in this business development effort Medical College of Georgia Office of Technology Transfer & Economic Development Interdisciplinary Research Center 1462 Laney Walker Blvd CA 2124 Augusta, GA 30912-7624 Phone: 706-721-9822 Fax: 706-721-2917 E-mail: rmarcus@mcg.edu Page 5 We’re on the Web! www.mcg.edu/research/ techtransfer Transforming Academic INNOVATIONS Into Healthcare IMPROVEMENTS Ask Dr. G (An Intellectual Property Advice Column) Can a faculty member start up a company at MCG? the internet to transmit critical data from remote areas to a Absolutely…provided that several things are done in the right sequence. The first step is to contact the OTTED office and speak with Chuck Nawrot and/or Mike Gabridge. We will discuss the nature of the proposed venture, the product idea, the intellectual property position, and the business model. We also will chat about the company’s needs for space, personnel and funding. Of course, if a faculty member wants to be directly involved in operations or management of this company, he/she will need to discuss this with their Department Head, Dean, and MCG legal counsel. This is to define, and deal with, any issues related to Conflict of Interest and Conflict of Commitment. The issue of time and attention is important, since faculty have obligations to the institution. If your time at the company will be significant, you may have to consider a leave of absence. If all goes well, and there is an acceptable business plan, the OTTED office will assist with space and funding opportunities, as resources will allow. We do have certain opportunities when it comes to equipment and support, especially if the company will reside in the MCG business incubator. certified neurologist. Just keep in mind that a faculty member who becomes an entrepreneur will be making a significant contribution of his/her time, energy…and finances…while bearing some risk. It is all part of the process, and a very exciting one at that. Can I use the labs in the MCG incubator? Yes, but only if you have a company. Faculty can use the common equipment in the incubator, but the actual lab suites are reserved for rent by life sciences companies. The Life Sciences Business Development Center (and now the “Innovation Center” – one of only 6 in the state), offers space, equipment, furnishings, and a series of assistance programs to companies that are just starting up. Hence, the typical biomedical operation can come into the incubator and have an almost “turn-key” situation since we have provided most of the basic elements to start and run a business venture. The incubator is not available to faculty members who just need more research space. On the other hand, if they are working on product-related activities, and want to form a new company and submit an SBIR research proposal, or provide products or services in the medical area, we should talk. One of the newest faculty spin-off companies (one based in large part on MCG intellectual property) is “REACHMDconsult, Inc.”. It was founded by sevSee www.MCG.edu/incubator. eral faculty and staff people from the Department of Neurology, and it already won a statewide competition (and a $100,000 cash prize and $150,000 in professional business services) for their business plan and company idea. They are in the telehealth arena, and deal with rapid treatment for stroke victims by using (Continued from page 2) Page 6 products are reviewed. The single most important step inventors can take to expedite the process is to make of record the most pertinent prior art as early in the examination process as practicable. If the most relevant prior art is made of record early in the process, it aids the examiner’s understanding of the technology that is described and claimed in the application and may assist the examiner when they design and execute their own prior art search. Prior art references can also provide valuable evidence in establishing that the claims in the application meet the enablement and written description requirements of the patent statutes. What are the qualifications to become a Patent Examiner? The qualifications are set forth at http://www.uspto.gov/ web/offices/ac/ahrpa/ohr/jobs/qualifications.htm. Essentially, the candidate must be a citizen of the United States and possess a science or engineering background. The precise education requirements vary from discipline to discipline. Getting to the Core of the Matter by Abhit Afzulpurkar, Ph.D Technology Transfer Associate/ Core Lab Manager Placenta/Umbilical Cord Blood-derived Stem Cell Core MCG is strategically placed to benefit from the new state initiatives on non-embryonic stem cells. A commission, created by an executive order from the governor in April, will establish a network of postnatal tissue and fluid banks in partnership with universities, hospitals, nonprofit organizations and private firms in Georgia. Drs. David Hess and Robert Yu have been appointed to the Commission for Newborn Umbilical Cord Blood Research and Medical Treatment by Gov. Sonny Purdue. A core facility is already in place at MCG, operates from CA-1064 and is licensed by the International Council for Commonality in Blood Banking Automation. The facility collects, processes and cryopreserves donated umbilical cord blood. Other services in the pipe-line are consulWhat other sorts of changes do you see on the horizon in tation, distribution of human cord blood-derived progenitor cells, immunohistochemical analysis of transregard to our patent system? planted stem cells, data management and statistical It seems that changes to the patent system are inevitable. analysis. Instrumentation includes a computer conOne of the less controversial reform propositions is to institrolled liquid N2 cryopreservation and storage system tute a post-grant opposition proceeding. Once a patent has BioArchive System – with a robotic storage and retrieval issued, interested members of the public would have a relacapability and sample management system software. tively short period of time, e.g., nine months, to file an oppoThis was procured through a grant from the Georgia Resition to the patent in the USPTO. Since most patent apsearch Alliance. A Becton Dickinson FACScan flow cyplications are now published within eighteen months of filtometer dedicated for human samples and a blood-cell ing, persons and companies are generally aware of the patent analyzer, also from BD are also installed. activity of their competitors and can be in a position to opDay-to-day operations of the facility are performed by pose any patent once it is granted. The proponents of this procedure argue that a post-grant opposition would allow the Dr. Jeane Silva under the overall guidance of Drs. Sean Liour, Ali Eroglu and Bob Yu. early resolution of patent rights between competitors. It is envisaged that the opposition proceedings would be conFor more information, please email or call Dr. Silva at: ducted before the Board of Patent Appeals and Interferences in a manner that would be quicker and less expensive than if jsilva@mcg.edu , phone: 721-1136 the patent were litigated in a federal district court. Others would argue that a post-grant opposition would present an opportunity for larger, well financed competitors to harass smaller, less financially well off competitors. Of all the proposed reforms, post-grant opposition appears to have the most momentum and, if offered in a stand alone bill, may pass Congress in a relatively short time. From Left to Right: Drs. Eroglu, Yu, Silva