In high school chemistry class we watched a movie in which nothing less than a magical transformation took place.   A scientist mixed two parts hydrogen gas and one part oxygen gas in a clear, sealed container, then sent an electrical charge into it.   It created a spark, which provided the energy to force the two gases to join together in an explosive chemical union.   The result was that they became a composition of matter which we recognize to be water.

      Composition of matter is a term within the federal statute that determines patent eligibility, that of 35 USC § 101.   It, along with the other terms we’ve been discussing, such as machine, and article of manufacture, is yet another consideration which must be addressed on the road to patentability.

      To get a handle on the meaning of composition of matter, we have to go back to the Supreme Court’s ruling in Diamond v. Chakrabarty, a landmark case introduced in last week’s blog.   Here the court defined composition of matter as, “compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids.”   The Court’s definition of composition of matter covers chemical compounds and composites.

      The Merriam-Webster Dictionary, defines a composite as something “made up of distinct parts.”   Composite articles include most of the man-made products modern society is so familiar with and can’t seem to live without.   Examples include plywood, concrete, and fiberglass.   They’re typically made up of a myriad of components, some of which are raw materials, some man-made chemical compounds.

      Chemical compounds are commonly made by uniting two or more chemical elements, the basic building blocks of matter that you might be familiar with from the Periodic Table always on display in a high school chemistry classroom.   When a chemical union takes place the elements are forced, by way of mixing and heating, to bind together at the atomic level.   If you’re not quite sure what “atomic” means, visit this site for a brief refresher: Atom Definition

      Chemical compounds include man-made things like fuels, plastics, fertilizers, food preservatives, pesticides, and cleaning solutions.   They’re all things that require human intervention to produce.

      You may not realize it, but metal alloys are also essentially chemical compounds.   These alloys are formed when two or more metals, or a metal and nonmetal, are fused together.   Steel, for example, is an alloy composed of multiple elements, including iron, nickel, and carbon, which mix together during heating and become molten.   During cooling the elements firmly unite and form atomic bonds to produce a new solid, one not available directly from nature.

      Next time we’ll wrap up our discussion on 35 USC § 101by discussing the meaning of process with regard to patent eligibility.

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      Imagine having freshly baked pastries available to you all day long, every day, while at work.   I’m not talking about someone bringing in a box of donuts to share, I’m talking about baked goods on a massive scale.   This is what I experienced in one of my design engineering positions within the food industry.   These baked goods constituted the articles of manufacture of the food plant, and they presented a constant temptation to me.

      Just what constitutes an article of manufacture is another aspect of the second hurtle which must be passed to determine patent eligibility.   It is addressed under federal statutes governing the same, 35 USC § 101, and is contained within the same area as the discussion of what constitutes a machine, a subject we took up previously in this series.

      Why bother defining articles of manufacture?   Well, while hearing the patent case of Diamond v. Chakrabarty regarding genetically engineered bacterium capable of eating crude oil, the US Supreme Court saw fit to define the term so as to resolve a conflict between the inventor and the patent office as to whether a living organism could be patented.

      The net result was the Court declared that in order to be deemed a patentable article of manufacture the object must be produced from either raw or man-made materials by either hand labor or machinery and must take on “new forms, qualities, properties, or combinations” that would not naturally occur without human intervention.   In other words, a creation process must take place and something which did not previously exist must be caused to exist.

      The court’s definition of articles of manufacture encompasses an incredible array of products, much too vast to enumerate here.   Suffice it to say that the defining characteristic is that if it should consist of two or more parts, there is no interaction between the parts, otherwise it could be categorized as a machine.   In other words, the relationship between their parts is static, unmoving.   An example would be a hammer.   It’s made up of two parts, a steel head and wooden handle.   These parts are firmly attached to one another, so they act as one.

      Next time we’ll continue our discussion on the second hurtle presented by 35 USC § 101, where we’ll discuss what is meant by composition of matter.
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      During 6th grade science we had a chapter on Simple Machines, and my textbook listed a common lever as an example, the sort that can be used to make work easier. Its illustration showed a stick perched atop a triangular shaped stone, appearing very much like a teeter-totter in the playground. A man was pushing down on one end of the stick to move a large boulder with the other end. Staring at it I thought to myself, “That doesn’t look like a machine to me. Where are its gears?” That day I learned about more than just levers, I learned to expect the unexpected when it comes to machines.

      Last time we learned that under patent law the machine referred to in federal statute 35 USC § 101 includes any physical device consisting of two or more parts which dynamically interact with each other. We looked at how a purely mechanical machine, such as a diesel engine, has moving parts that are mechanically linked to dynamically interact when the engine runs. Now, lets move on to less obvious examples of what constitutes a machine.

      Would you expect a modern electronic memory stick to be a machine? Probably not. But, under patent law it is. It’s an electronic device, and as such it’s made up of multiple parts, including integrated circuit chips, resistors, diodes, and capacitors, all of which are soldered to a printed circuit board where they interact with one another. They do so electrically, through changing current flow, rather than through physical movement of parts as in our diesel engine.

      A transformer is an example of another type of machine. An electrical machine. Its fixed parts, including wire coils and steel cores, interact dynamically both electrically and magnetically in order to change voltage and current flow.

      Electromechanical, the most complex of all machine types, includes the kitchen appliances in your home. They consist of both fixed and moving parts, along with all the dynamic interactions of mechanical, electronic, and electrical machines.

      Next time we’ll continue our discussion on the second hurtle presented by 35 USC § 101, where we’ll discuss what is meant by article of manufacture.

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      One of my favorite toys as a kid was Mr. Machine.   He was a windup mechanical man that swung his arms when he walked while repeatedly squawking a strange YAK! sound.   His body was transparent, so all the gears and levers inside were visible, and he even came with his own repair wrench.   Alas, his wrench was of little use when Mr. Machine took a tragic fall down the basement stairs.

      Mr. Machine was aptly named.   There’s no question but that he was a machine, because his inventor received a US patent, No. 3,050,900.   In order to accomplish this he had to have met guidelines set out in federal statutes, specifically those contained in 35 USC § 101.   He had to prove that Mr. Machine was a bona fide machine.

      If you’ll recall from last week’s discussion, in order to secure a patent, inventions must prove to be original technology that is classifiable as a machine, an article of manufacture, a composition of matter, or a process, or an improvement upon same.   Last week our focus was on utility, the first hurdle that an invention must jump for it to be patent eligible.   Let’s continue our discussion on patentability by examining the second hurtle.

      When you consider the word machine, you might imagine something containing mechanical parts, like my childhood mechanical friend.   But in the world of patents that’s not necessarily the case.   There, a machine can be mechanical, electrical, electronic, or electromechanical in nature.   In other words, a machine can include anything from a cell phone to a rocket.

      To be precise, under patent law the definition of machine includes any physical device consisting of two or more parts which dynamically interact with each other.   For example, a purely mechanical machine, such as a diesel engine, has many moving parts.   Those parts, the pistons, connecting rods, etc., are mechanically linked to dynamically interact, or move together, when the engine runs.

      Next week we’ll consider less obvious examples of what constitutes a machine under patent law.

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      When I was growing up in the 1960s the Chicago Tribune featured a comic strip by Bill Holman called Smokey Stover.   Smokey was a fireman who had all sorts of ridiculous, nutty, and even bazaar inventions, like his two-wheeled fire truck called the “Foomobile.”   In the real world his inventions could never work, but that didn’t stop me from being a kid and enjoying Smokey’s goofy adventures.

      Smokey’s fire truck would never pass a patent test.   Why?   Because it wouldn’t get past the first requirement for patentability, that is, utility.

      Last time we introduced the federal laws governing patents as found in Title 35, Section 101, of the United States Code (USC), 35 USC § 101 for short.   It sets out requirements for patentability, and the first hurdle that an invention must jump is that it must possess the quality of utility.   In other words, it must be useful.

      This quality of utility prevents ridiculous and/or hypothetical devices, such as Smokey’s Foomobile, from receiving a patent.   Because the Foomobile consists of an engine and two wheels mounted on a single axle, there’s nothing to keep it from falling over.   The weight of its engine makes it front-heavy and unstable.   The nutty vehicle will tip forward, and its front bumper will become wedged in the ground.   The Foomobile is just not capable of passing the test of utility because it cannot be operated as intended – Smokey would never make it to the scene of the fire – and it’s unable to provide any identifiable benefit to its users.

      Once the hurdle of proving an invention’s utility is passed, the next considerations for patent eligibility must be addressed.   Is the invention a machine?   A process?   Just what defines a machine?   Is it something with gears and a motor?

      Next time we’ll see how within the context of patent eligibility, the word machine can apply to things which are not at all mechanical.

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      Last time I introduced the concept of intellectual property, or IP.   We learned that IP in the eyes of the law is recognized as a creation of an individual inventor’s mind, worthy of commercial value.   It goes to follow that those inventions that have been awarded patents are also a form of IP, because they represent the working ideation of the inventor’s mind.   As such, the patent grants the inventor the sole legal right to profit from the invention to the exclusion of all others.

      So all you need is an idea, and you can apply for a patent, right?   Well, not really.   There are in fact a number of tests that potentially patentable inventions must pass.

      Federal laws governing patents have been in existence since 1790.   They were put in place to give inventors the means to legally protect their exclusive rights to profit from their inventions in our new country.   The first patent was awarded to inventor Samuel Hopkins on July 31st of that year, for a process he created to make potash, an ingredient used to make fertilizer.

      Since that time, the patent laws have been continually revised and expanded to improve the patenting process, something that became necessary due to the explosion of patentable technological innovations after the Industrial Revolution started in the 19th Century.

      In July of 1952, the basic structure of modern patent law was laid out by Title 35 of the United States Code (USC).   Title 35 is a set of laws drafted by Congress that contains all federal statutes governing patents.   Within Title 35 is found Section 101.   It’s the part that addresses patent eligibility.   This Section is commonly referred to within the trade by patent agents and attorneys as 35 USC § 101, shorthand for “Title 35 of the USC, Section 101.”

      According to 35 USC § 101, in order to be patentable an invention must first be useful.   In addition, it must be either a machine, an article of manufacture, a composition of matter, or a process, or it must improve upon an existing machine, article of manufacture, composition, or process.   But what does this all really mean?   We’ll find out next time.

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      While pursuing my engineering degree my professors provided me with a thorough understanding of mechanical and electrical design and instruction on how to build prototypes for testing.   As far as technical skills were concerned, I was well equipped to turn my ideas into real inventions.   Unfortunately, my engineering school, like most others, never went beyond these technical aspects of inventing.   For example, we never discussed the business and legal aspects of manufacturing and selling an invention.

      The fact is, most first time inventors have little or no understanding of how to go about obtaining a patent to prevent others from copying and profiting from their inventions.   They also tend to take a haphazard approach to inventing, neglecting important issues such as whether a market for their invention exists, or whether they will face competition already in place.   A lot of time and money can be spent developing an invention, only to discover that it had already been patented by someone else.   They do all the up-front work, blissfully unaware of the repercussions of negative possibilities, like getting sued by any existing patent holder, suits which are among the most expensive to defend.

      For most individuals the patent process is a hotbed of mysteries and misconceptions.   Let’s start unraveling them by first gaining a basic understanding of what a patent is.

      In short, a patent grants you a legal right, much like other legal rights you may be more familiar with.   For example, if you own property, say a car or piece of real estate, you’re provided with a legal document known as a title.   This title defines your legal right to own that property.

      Similar to a title, a patent grants you the legal right to own intellectual property, or IP, as its inventor.   IP is a term used in the business and legal arenas to refer to creations of the inventor’s mind.   Once patented, these creations become the property of the inventor, and they have commercial value.   This value is derived from the fact that the patent can be used to exclude others from producing the invention and profiting from it.   The IP rights can also be sold or licensed to others for a profit.

      IP can encompass subjects as diverse as machinery, articles of manufacture, compositions of matter, and many diverse processes, all of which we’ll look into during the course of this blog series.

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      Who hasn’t finished a project, only to discover that you’d done something wrong and the whole thing would need to be redone?   Perhaps you hadn’t checked your work along the way, confident that all would be well in the end.   Imagine the costs involved if this scenario were to take place on a commercial production line.   The Systems Engineering Approach to things helps ensure this doesn’t happen.

      Last time we wrapped up our discussion on the Production stage of the systems engineering approach to medical device design, and today we’ll cover the final stage, Utilization.

      The Utilization stage marks the point at which the medical device has been sold and is in actual use in the marketplace.   Despite the fact that the product has at this point undergone many reviews and revisions and a great investment has been made into deciding whether or not to put it into production, changes can still take place in its design.   Markets aren’t static, and products may be made to change due to stakeholders’, that is, those with a vested interest, changing requirements, whether those are aimed at further cost reduction, or perhaps to implement innovations to make the product more appealing to end users.

      Other reasons for change may be initiated by the sales and marketing departments.   They keep their fingers on the pulse of consumer trends, and they may want the design modified according to market research and feedback they receive from dealers, service technicians, and end users.

      For example, the sales staff may have been apprised by end users that the keypad to their electronic muscle stimulating device needs modification. Patients have voiced they would prefer to here a clicking sound when depressing the buttons, in order to receive some auditory feedback.   In addition, distributors of the device reported that although the electronic stimulators were functioning as intended, end users didn’t like the feel of the buttons.   The lack of tactile feedback often led to confusion because they weren’t sure whether they had depressed the button or not.

      Another interesting discovery concerning lack of feedback was that product service technicians were reporting premature wearing out of the keypads.   Absent the satisfying click sound, users were inclined to push on the pads too strenuously, which drove up warranty service costs.   The medical device manufacturer’s stakeholders are always concerned with costs, and increased service costs definitely raise the red flag.

      Considerations like these typically arise after a medical device enters the Utilization stage.   Fortunately, the objective of the systems engineering approach is to ensure that stakeholders’ needs are met in view of ever-changing requirements, even after the device has entered the marketplace.   No matter what may happen during the life cycle of a product, the systems engineering approach is used every step of the way, from the Concept stage through to Utilization.

      That ends our discussion on the systems engineering approach to medical device design.   Next time we’ll begin unraveling some of the mysteries and misconceptions behind patenting inventions.

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      Did you know that from the early days of the Industrial Revolution until well into the 20th Century it was common practice for all aspects of a product to be built entirely under one roof? For example, a wheelchair manufacturer in the 1890s would buy the various raw materials needed to construct component parts, everything from bars of steel and wooden boards to rattan stalks and gum rubber, then produce every part of the wheelchair in one facility. Items as diverse as chair frames, footrests, wicker seat cushions, springs, wheel rims and spokes, and tires would all be constructed from the raw materials purchased, then assembled into the finished product.

      Doesn’t sound like an efficient process to you? Henry Ford didn’t think so either. In fact, he is credited with pioneering mass production in manufacturing when he observed during the production process of his line of automobiles that inefficiencies abounded.

      Inefficiencies in manufacturing are common, as they are in everyday life. Last time we saw how robots, i.e., the introduction of industrial automation, can be used during the Production stage of our systems engineering approach to medical device design to increase efficiency and reduce manufacturing costs. Today we’ll take a look at another inefficient practice, along with its solution.

      Returning to our wheelchair manufacturer, the problems associated with manufacturing and assembling all aspects of a product are many. At the top of the list is the substantial cash outlay that’s required to buy and maintain a huge factory complex and all the specialized equipment required to make each and every part. In addition, there’s the ongoing expense of employing and training employees needed to fabricate each component. In other words, the wheelchair factory has a lot of fixed overhead expense to carry, and the more overhead there is, the more expensive the end product. Expenses such as these are almost always passed on to the buyer.

      The solution? Outsourcing. That is, using outside manufacturers to produce many, perhaps even all, of the component parts. Then our wheelchair manufacturer would simply assemble the purchased parts into the finished product, resulting in lower manufacturing costs and higher profits. The benefits of outsourcing were widely recognized in the decades following World War II, when the post-war economy was booming and demand for consumer goods increased dramatically.

      That ends our look at the Production stage. Next time we’ll move on to the Utilization stage to see how the systems engineering approach is put into play once the medical device has been introduced into the marketplace.

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     Today’s generation of robots do not often take on the humanoid form, but they’re capable of so much more.  Robots on assembly lines perform a variety of tasks like welding and placing electronic components on circuit boards, and they do it much more quickly and accurately than any human could, so they’re often employed in manufacturing.

     We’ve been discussing the Production stage of the systems engineering approach to medical device design.  We learned that within the manufacturing process there are often opportunities for cost reduction, and today we’ll see how robots can be used to reach those goals.

     Last week we presented a sample scenario involving the manufacture of a percussion therapy device.  In their quest to reduce manufacturing costs, engineers identified bottlenecks along the assembly line which led to idle worker time and the inability to keep up with orders.

     In addition to these production woes, it was discovered that the tedious, repetitive manual labor that occurred at each bottleneck created opportunities for assembly mistakes.  As many as 30 devices per day were being rejected by quality control inspectors due to issues such as faulty wiring and improper parts usage.  This led to expensive rework to correct mistakes.

     After further evaluation, design engineers determine that bottlenecks can be eliminated by installing automated assembly equipment in the three distinct assembly stages represented on the line, those involving wiring harnesses, printed circuit boards, and the motor drive mechanism.

     The potential for human error is high during many facets of manufacturing, and this can be minimized or eliminated through the use of robots, that is to say, mechanized equipment capable of automatically performing a complex series of specific tasks.  These robots never tire of performing tedious, repetitive work, and their efficiency is unparalleled.  Their introduction at key junctures on the assembly line has benefits across the manufacturing process, enabling workers to keep continuously busy and reducing the incidence of human error.

     The introduction of robotics is known as industrial automation.  Robots efficiently increase manufacturing speed, and along with it profits, so their introduction more than compensates for the investment costs associated with purchasing them.

     Next time we’ll continue our look at the Production stage to discover another way that systems engineering can simplifying the assembly process, by eliminating some functions altogether.

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