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Date Created: 11/02/15
Final Exam Review Spring 2012 BMED 2300 Intellectual Property Lecture Independent Claim Dependant Claim claims which stand on their own claims which depend on a single claim or on several claims and generally express Ex 1 A cutting tool comprising particular embodiments as fallback positions 0 a first member having a first cutting edge Ex 2 The cutting tool of claim 1 wherein the o a second member having a second fastener comprises a cutting edge and pivot pin 0 a fastenerfor coupling the first 3 The cutting tool of claim 1 or member to the second member claim 2 wherein the first cutting edge and the second cutting edge are serrated Types of Intellectual Property Uses Patent provide market advantages for a limited number of years 1720 as a reward for the development of a new technology facilitate sharing of new ideas and technologies Copyright Mark Trade Dress Trade Secret Types of Patents 1 Utility Patent 0 protects the way something works is used or is made 0 generally what is meant or thought of as a patent 2 Design Patent 0 protects the ornamental design of a productarticle 3 Plant Patent 0 protects hybrid plant varieties Patent Bargains I Inventor gets exclusive rightsquot for a limited time I Public gets full disclosure of the technology and right to use the patent when patent expires I Places emphasis on the patent document itself 0 Patent rights flow from patent application I Written description or specification I Drawings when appropriate I Claims 0 Claims define the scope of patent monopoly 0 Each independent claim stands alone 0 Dependant claims depend of the independent claims Requirements for a Patent Application 1 Enablement a Teaches how to make and use the invention without undue experimentation 2 Written description of invention a explains what the applicant believes the scope ofthe invention to be 3 US Only best modequot a duty to describe the best mode of the invention known to the inventor at the date of filing The more articulate the disclosure about the ideaproductetc being patented the stronger the utility patent More detailed patent specification supports broader claims Patent Claims a series of numbered paragraphs that define the scope of invention usually arranged from broadest to narrowest may include apparatus method of makingmanufacturing method using etc obtaining allowance of claims is a negotiation most applications are usually rejected at first Design Patents scope is generally more narrowthan a utility patent subject of design patent can be a wide variety of things affordable quick effective narrow scope of protection underused in most cases overlooked in industries not driven by marketing Patent Timeline i Conception of idea i Existing Patent art research iquot Disclosure of idea to patent agent attorney i Draftingfiling of patent application v Examination of application by United States Patent and Trade Office v39 Issuance of patent 2 to 3 years v i Production of the device viii Too grand to produce Licensing ix Defending the patent lt Examination Process Examiners review application to ensure requirements are met Requirements Description Utility patentable subject matter review what was known to others at the time of invention gt novelty gt nonobvious What happens after a patent is issued 0 monitor activities of competitors to protect patent rights 0 Infringement on device I opinion of counsel analysis of patent vs device I may press charges for monetary damages or partner to grow company or art of idea 0 NO International protection 0 Each country is covered individually 0 Europe is moving towards Community patent W FDAvegmatesavev 5m aVPmdudsmthe Unwed States 39 100 Years of Regulahons rnA Focusr mm the Fume Numi39 Hm I Pmmm um um neguumms regmates Wsemsmvme desgn testmg manmsdunng msnbmmn and mended use m as and dewues 1 2mm u inoEsuoI EGHLAIEthe mamasmmewWyerhawphvsmansusepmdu s il 39 Me alDev cesmFDA canusmx Damn a molme new Bwnmlmfn FDAVEgmatesmedmm dew25 m 7 new mcess Dance REwllmn manly 19167Mulnunce Amm em Manmsmmng Regu atmns amps mm 751 Marinl Devices Am Repamng memm dawns has m mav have caused m mmnbmed a a dam Hness m an 199541me mg me negmm I Methods used facilities and controls for designing manufacturing packaging installing and servicing of medical devices intended for human use I PreQroduction design controls and consistency with quality system requirements worldwide I Framework for device manufacturers to follow in achieving quality requirements 1997 FDA Modernization Act I Accelerated review of devices I Regulate advertising of unapproved uses I Regulate health claims for foods 2002 User Fee amp Modernization Act I Established fees for product reviews I Established Office of Combination of Products Device Regulation Changes 510 k substantial equivalence procedure and requirements are under review and revision by FDA Positives Negatives safer medical devices goal longer and more expensive device development process movement of development into overseas markets delay of technological improvements Predicate Devices for Substantial Equivalence Legally marketed devices to which equivalence is drawn iustified in 510k application for FDA Claim of substantial equivalencequot does not mean the devices must be identical Substantial equivalence with respect to intended use design energy useddelivered materials performance safety effectiveness labeling biocompatibility standards and other applicable characteristics FDA Requirements Patent Office FDA 510 k Clearance USPRO Patentability Substantial Equivalence Novel Intended UseApplication Nonobvious Characteristics Useful function materials operational method sterilization method safety effectiveness United States FDA Medical Device Classificatons Class General Controls 0 Establishment Registration for company importer of 200800 per year 0 Medical Device Listing of products with FDA 0 Products made in accordance with Good Manufacturing Practices cGMPs o Labeling claims and advertising in accordance with FDA labeling regulations 0 Most products in this class are not subject to notifying FDA before selling product I Class Examples 0 manual wheel chairs 0 elastic bandages general hospital furniture examination gloves patient use items handheld surgical instruments 0 ll Class II Standards 0 For which general controls alone are insufficient to assure safety and effectiveness 0 Must comply with Class General Controls 0 Subject to Standards or Guidance Documents Company submits 510 k notification document 4049 fee Small Business 2024 0 0 FDA reviews 90 days to respond to company 0 FDA provides Clearance to market product I Class II Examples 0 Powered Chairs and Monitors 0 Craniofacial Implants 0 Orthopedic lmplants lll Class III Premarket Approval 0 quot quot quot 39devices With patient39 quot 0 Can be a device or applicationuse of a device 0 Supports or sustains human life 0 Potential unreasonable risk of illness or injury 0 Premarket Approval ApplicationPMA I Submission100000 to 500000 pages 1 Indications for use claims 2 Proven clinical safety amp efficacy clinical studytrials 3 Manufacturing Processes amp Procedures premarketing audit by I Plus 220050 filing fee Small Business 55013 0 Class III Examples I Vascular Stents Heart Valves Breast Implants Combination devices What s the primary product 0 Drug Eluding Stents stent a device gt CDRH Sirolimus or paclitaxel drug gt Drug division 0 lnfuse Bone Graft Medtronic o Collagen sponge and bone morphogenetic protein n cuman Mum1mm w 4 quotanquot aunt m the quotSA neuan WI ls reeeaaeeally I Regulatory Strategy important 3 Safety and Efficacy Safe for stated and claimed use Minimal risk of misuse or unintended action Effective in providing benefits from using Device Classification Panels Anesthesiology Cardiovascular CIinical Chemistry and Clinical Toxicology Dental Ear Nose and Throat 76 Gastroenterology and Urology 78 General and Plastic Surgery 80 General Hospital and Personal Use 64 Hematology and Pathology 66 Immunology and Microbiology 82 Neurology 84 Obstetrical and Gynecological Ophthalmic 88 Orthopedic 90 Physical Medicine 92 Radiology 00 00 00 00 00 00 00 0000 00 00 K91 man Englmus Qul y Sylum KEEN1mm in 21 Pm m mm can 11 Fmenl Raganuns 39 Clual ySyslems Raulalions QSRSKBSmnnnstwimjlms Ouahw SVSlems Audns unnawamnaag Design Re nement Lecture Why Prototype 0 Design Verification Functional Testing 0 Find error earlier the better 0 Evaluate operational systems and functions 0 Design Validation User Experience and Feedback 0 Communication and Information 0 Human factors evaluation of design layout touch feel spatial relationships size shape colors etc 0 Usability feedback 0 Regulatory Requirement for Medical Devices 0 FDA Quality Systems QS Regulations 0 FDA Design Controls Requirements 0 ISO 13485 Design Control Requirements 0 Risks Assessment for Medical Devices 0 FDA QS Regulations and ISO 14971 2009 0 Failure Modes and Effects Analysis FMEA 0 Finite Element Analysis FEA 0 Safety Responsibility and Liability Types of Prototypes l Breadboard prototype clarify project goals identify requirements examine alternatives explore parameters ll Proofofconcept prototype test function and performance controlled experiments prove or disprove lll Alpha prototype actual or reduced size made using similar materials and layout as design concept lV Beta prototype fullscale functional prototype made using materials and manufacturing methods intended for final design V Pre Production prototype made with production materials and procedures trial run for Phase III clinical studies Vl HighFidelity Virtual Prototype Finite Element Analysis FEA 39with 39 39 Iik and Questions to ask when assessing prototype Who was there What was done What does it feel like Is it real Does it work Tips for Models and Prototypes 1 Decide what to communicate What stage are you in design process 2 Decide what functions or attributes to evaluate 3 Decide how you will evaluate 4 Protocol testing evaluation and analysis 5 Verify function and performance and validate usability and feeling 6 Customers have a hard time understanding if they are not innovators Do not lie or hedge against the clock Wm Communication Steps Genera Gummy w m r w Enamnng mung High Tech Design Tools 3D File Standards IGES Initial Graphics Exchange Specification is a file format which defines a vendor neutral data format that allows the digital exchange of information among Computeraided design CAD systems First published in 1980 by the Department of DefenseDoD as a unified PDF of the CAD worldquot OUTDATED Not useful data for manufacturing IGES PROS IGES CONS True VectorSpline Format Nonparametric Almost universal format Can be opened by Must include 2D IGES drawings to show any CAD system assembly configuration no IGES assembly files exist STEP Standard for the Exchange of Product Model Data The initial plan was that quotSTEP shall be based on one single complete implementation independent Product Information Model which shall be the Master Record of the integrated topical and application information modelsquot But because of the complexity the standard had to be broken up into smaller parts that can be developed balloted and approved separately In 199495 ISO published the initial release of STEP as international standards with parts that are still used today Consists of several hundred parts and every year new parts are added or new versions of older parts are released This makes STEP the biggest standard within ISO Each part has its own scope and introduction STEP PROS STEP CONS More recent and less problematic than IGES Hundreds of versions of STEP all with when used for complex work different capabilities Can contain assemblies Nonparametric but can be reverse engineered by SolidWorks Parasolids Capabilities include model creation and editing utilities such as Boolean modeling operators feature modeling support advanced surfacing thickening and hollowing blending and filleting and sheet modeling Also includes tools for direct model editing including tapering offsetting geometry replacement and removal of feature details with automated regeneration of surrounding data Parasolid also provides wideranging graphical and rendering support including hiddenline wireframe and drafting tessellation and model data inquiries Msmethad an be used m Sahwvmks When expaned m the Parent Mme Package e Pavasahd mmman v hasthe me extensan x Anmhev mm s u Wde 5er hmarv we SD n smme meme meepeneem and nut subye m mnemmn mnvevsan evmvs Mas Pavasuhd mes En cammummle and quotHarms my so su cammummle and quotHarms 20 data su Ms enemsuneee em 7 Pavasuhd mes mnem vcannm en es hnes and was Pnmlms cons Mast Men and rehab e emssmenem Sam ewes Veatuves ave nm vewgmzed mememe sz SWMarmat pmpenm makmgthem dmmma edn SmaH me sees even assembhes m use x as x s sumahmes ess thausands av pens suppanee Can Pack an arms assemh v m me me sn 7 sumn1 I Imnn Lulum descnhe anWe smeee geamehy m e twee mmensana amea mm aw representater m em extme m mhev mm man cm made emWes wde v used my mum mmmvpme and campmeveaxded manmschmng me assumes e mwunsmdured marvgmated sweee bvthe mm mm and vemeesmeeyee bvthe Hgmehand Me anhemang es usng emeemmensanew Canesan cammnate smem wov e vahd manmadurmg me u shap senesmsmes Capah e m Meme nmse m cm Scan m my Wageser avdevm madeHhe wage m so as e senesmmarvg es Examme Lungs made ed m an my Othev me Vuvmats mpeme menmdmgmang es nc ude VRML and so par svlmmuukasb vs Pnlygms Rastevvs Veammnwappuesmzo ems NURBS 7 mahemmca mm mm use emeemmv ewes mesmees We a m ewe vvavmcs m meme m was We mmhemmca m Element Analysis technique for finding approximate solutions of partial differential Finite a numerical equationsPDE as well as integral equations Allows detailed visualization of where structures bend or twist and indicates the distribution of stresses and displacements Allows entire designs to be constructed refined and optimized before the design is manufactured Tool called in SimulationXpress in SolidWorks ZCorp Composite Printing Laser cutters etc ZCorp Composite Printing PROs ZCorp Composite Printing CONs Fast approx 1 inch per hour in depth Fragile temporary models Requires a lot of babysitting to make sure the Relatively inexpensive 15cu inch machine works correctly We have this in BME Fused Deposition Modeling an additive manufacturing technology commonly used for modeling prototyping and production applications works on an quotadditivequot principle by laying down material in layers Used for prototyping and rapid maunfacturing Fused Deposition Modeling PROs Fused Deposition Modeling CONs Real engineering resins used sturdy parts Slow build Machinable after the fact tapping holes etc Expensive material 25cu inch We have this in BME Slow postprocessing Selective Laser Sintering an additive manufacturing technique that uses a high power laser for example a carbon dioxide laser to fuse small particles of plastic metal direct metal laser sinteringceramic or glass powders into a mass that has a desired 3dimensional shape The laser selectively fuses powdered material by scanning crosssections generated from a 3D digital description of the part for example from a CAD file or scan data on the surface of a powder bed After each crosssection is scanned the powder bed is lowered by one layer thickness a new layer of material is applied on top and the process is repeated until the part is completed Selective Laser Sintering PROS Selective Laser Sintering CONs Looks like a real injectionmolded part Fairly expensive Could cost as much as a machined part Works like a real injectionmolded part depending on the design Laser Cutting a technology that uses a laser to cut materials Works by directing the output of a highpower laser by computer at the material to be cut The material then either melts burns vaporizes away or is blown away by a jet of gas leaving an edge with a highquality surface finish Laser Cutting PROS Laser Cutting CONs Requires less human involvement than Can only cut sheet materials machinIng Fast for VectorSpline work Two dimensional cutting generally Can engrave text and graphics on anodized surfaces No postprocessing required generally BuildCost amp Time Constraints Build envelope Time Constraints PostProcessing Constraints Appropriate Design Material Properties Cost versus time Atspwux 325m war ms 1hUcu man mous 34 non Aapmx 35 mm mm mm plus Lms hermit resets Appmx mums ulDusmrmassmg ma Term Definitions 1 9 A A 12 13 14 Geometric lquot American Societv of 39 39 Design for Manufacturing DFM design based on minimizing the costs of production andor the time to market for a product while maintaining an appropriate level of quality simply producing the lowest cost product Design for Assembly DFA related to DFM must limit the number of components to the few that are essential to the working of the finished product designing for the assembly to have as little motion of the base component as possible Bill of Materials BOM a list of all the parts including the quantities of each part required to assemble a designed object Time Value of Money captures the effects of both forgone opportunities referred to as opportunity costs and risksa dollar today is worth more than the promise of a dollar tomorrow Inside Diameter ID The length of a line which passes through the center of a hollow cylindrical or spherical object and whose endpoints lie on the inner surface of the object Outside Diameter OD The length of a line which passes through the center of a hollow cylindrical or spherical object and whose endpoints lie on the outer surface ofthe object Quality Control QC a process by which entities reviewthe quality of all factors involved in production Coordinate Measurement Machine a device that can be programmed to examine a specific part for its adherence to the geometric tolerances specified on the drawings American National Standards Institute ANSI serves as a clearinghouse for the individual standards written by professional societies eg ASME lEEE and associations eg NFPA AISC that govern various phases of design also serves as the national spokesperson for the United States in working with other countries and groups of countries eg the European Union to ensure compatibility and consistency wherever possible and T 39 GDampT a standard approach that refers to the ASME Y145M1994 Dimensions and Tolerances standards that establish a common language in which we create engineering drawings 39 quot39 39 ASME a professional association that in its own words quotpromotes the art science and practice of multidisciplinary engineering and allied sciences around the globequot via quotcontinuing education training and professional development codes and standards research conferences and publications government relations and other forms of outreachquot Computer Aided Design CAD the use of computer technology for the process of design and designdocumentation f nmmlter Aided 39 39 CAM the use of computer software to control machine tools and related machinery in the manufacturing of products and workpieces Food and Drug Administration FDA an agency of the United States Department of Health and Human Services responsible for protecting and promoting public health through the regulation and supervision of food safety tobacco products dietary supplements prescription and overthecounter pharmaceutical drugs medications