Posts Tagged ‘food manufacturing’

Determining Patent Eligibility – Part 7, Process

Sunday, May 26th, 2013

      We’ve been discussing hurtles which must be jumped in order for an inventor’s creation to be considered for a patent.   Federal statutes, namely 35 USC § 101, define the bases of patentability, including providing definitions on key terms, such as what constitutes a machine, an article of manufacture, and a composition of matter.   Today we’ll wrap up our discussion on determining patent eligibility when we explore the final hurtle by defining process.

      To get an understanding of what is meant by process, we must look to the lawsuit of Gottschalk v. Benson, a case involving patentability of a mathematical algorithm within a computer program.   In this case the US Supreme Court held that a process is a series of steps or operations that transform substances or came about by way of a newly invented machine.

      Based on the Court’s definition, a process can be many things, from a production line that transforms corn into corn chips within a food manufacturing plant to a mathematical algorithm running within software on the platform of a newly devised type of computer.   However, the term usually pertains to a series of operations or steps, most frequently manufacturing in nature, where physical substances are transformed into useful products, that is, they possess the quality of utility, as discussed earlier in this blog series.   A “physical substance” is anything of a physical nature existing on our planet.

 

Engineering Expert Witness Patent Infringement

 

      Before I end this series I’d like to mention that under 35 USC § 101 an invention can be eligible for a patent if it makes a useful and beneficial improvement to an existing machine, article of manufacture, composition of matter, or process.   That is to say, something may have already been patented which performs a specific function, but if that is improved upon in any significant way, it may receive a new patent.

      For example, suppose an improved process for manufacturing food products was developed by adding additional steps to an existing patented process.   If this improvement results in benefits such as lowered production costs, increased production rate, or reduced health risks to consumers, then this improved process may be eligible for a patent under 35 USC § 101.

      Next time we’ll begin an exploration of the growing presence of 3D animations within the courtroom, specifically how they bring static 2D patent drawings to life.

___________________________________________

Determining Patent Eligibility – Part 5, Manufactured Articles

Monday, May 6th, 2013

      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.

engineering expert witness food manufacturing

      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.
___________________________________________

Food Manufacturing Challenges – HACCP Design Principle No. 6

Sunday, November 20th, 2011
     My daughter’s boy friend stayed for dinner recently and was impressed with our after-dinner cleanup.  He watched as each of us carried out our individual assigned tasks, my wife putting away leftovers and condiments, my daughter rinsing and stacking plates into the dishwasher, and me at the sink hand washing.  To him we seemed a model of efficiency.  It didn’t take long to return the kitchen to its usual state of pristine evening cleanliness.  “Our kitchen is always a mess,” he complained, “probably because we’re so disorganized.”

     You can imagine what would happen if a food manufacturing plant operated like a disorganized household kitchen.  Although employees may know they are responsible for delivering safe products to consumers, without the right procedures in place an unsafe chaotic mess may result.  To get everyone moving in the right direction we look to guidelines established in HACCP Design Principle No. 6.

     Principle 6:  Establish procedures for ensuring the HACCP system is working as intended. –   In large part this Principle acts as a report card.  It follows up on the guidelines established in Principles l through 5, organizing activities into written procedures. 

     For example, design engineers must routinely analyze important identified stages within a design project, then write procedures, that is, a step-by-step instruction guide, which encompasses them.  In this way personnel involved in the design process make best use of the safeguards put in place by HACCP Design Principles 1 through 5.  These steps include things like preparing design proposals, analyzing risks and hazards, creating preliminary designs, conducting design reviews, building prototype equipment and tooling, running tests, collecting test data, and analyzing test results.  For each step, responsibilities of key individuals involved must be clearly defined and sequentially ordered.

     But writing department procedures is only part of Principle 6.  Procedures are no good if they’re just thrown into a file cabinet and no one ever looks at them.  What good are guidelines without a full understanding of how to use them?  Training may be necessary, and management must decide what form that educational process takes to be most effective.   

     Engineering management must verify that established procedures are adequate to the task.  This typically involves taking a hard look at finished design projects and checking critical factors.  Was an adequate risk analysis performed?  Were sufficient critical control points established and critical limits monitored for effectiveness? 

     Next time we’ll wrap up our discussion on HACCP Design Principles by examining No. 7.  It’s the last of the Principles and it’s concerned with establishing record keeping procedures.

____________________________________________

 

Food Manufacturing Challenges – HACCP Design Principle No. 4

Sunday, November 6th, 2011
     Imagine going on a diet and not having a scale to check your progress, or going to the doctor and not having your temperature taken.  Feedback is important in our daily lives, and industry benefits by it, too.

      Generally speaking, feedback, or monitoring, is a tool that provides relevant information on a timely basis as to whether things are working as they were intended to.   It’s an indispensable tool within the food manufacturing industry.  Without it, entire plants could be erected exposing workers to injury and consumers to bacteria-laden products.  It’s just plain common sense to monitor activities all along the way, starting with the design process.  Now let’s see how monitoring is applied in HACCP Design Principle No. 4.

     Principle 4:  Establish critical control point monitoring requirements. – Monitoring activities are necessary to ensure that the critical limits established at each critical control point (CCP) established under Principle 3 discussed last week are working as intended.  In other words, if the engineer identifies significant risks in the design of a piece of food processing equipment and establishes critical limits at CCPs to eliminate the risk, then the CCPs must be monitored to see if the risk has actually been eliminated.

     Monitoring can and should be performed in food manufacturing plants by a variety of personnel, including design engineers, the manager of the engineering department, production line workers, maintenance workers, and quality control inspectors.  For example, engineering department procedures in a food manufacturing plant should require the engineering manager to monitor CCPs established by the staff during the design of food processing equipment and production lines.  Monitoring would include reviewing the design engineer’s plans, checking things like assumptions made concerning processes, calculations, material selections, and proposed physical dimensions.

     In short, monitoring should be a part of nearly every process, starting with the review of design documents, mechanical and electrical drawings, validation test data for machine prototypes, and technical specifications for mechanical and electrical components.  This monitoring would be conducted by the engineering manager during all phases of the design process and before the finished equipment is turned over to the production department to start production. 

     To illustrate, suppose the engineering manager is reviewing the logic in a programmable controller for a cooker on a production line.  She discovers a problem with the lower critical limits established by her engineer at a CCP in the design of a cooker temperature control loop.  You see, the time and temperature in the logic is sufficient to thoroughly cook smaller cuts of meat in most of the products that will be made on the line, however the larger cuts will be undercooked.  The time and temperature settings within the logic are insufficient to account for the difference.  

     This situation illustrates the fact that monitoring does no good unless feedback is provided with immediacy.  In our example, the design engineer who first established the CCP and the critical limits was not informed in a timely manner of the difference in cooking times that different size meats would require, resulting in the writing of erroneous software logic.  Fortunately, continued monitoring by the engineering manager caught the error, leading her to provide feedback about it to the design engineer, who can then make the necessary corrections to the software.

     Next week we’ll see what design engineers do with the feedback they’ve received, as seen through the eyes of HACCP Principle 5, covering the establishment of corrective actions. 
____________________________________________

Food Manufacturing Challenges – HACCP Design Principle No. 1

Sunday, October 16th, 2011
     Imagine a doctor not washing his hands in between baby deliveries.  Unbelievable but true, this was a widespread practice up until last century when infections, followed by death of newborns, was an all-too common occurrence in hospitals across the United States.  It took an observant nurse to put two and two together after watching many physicians go from delivery room to delivery room, mother to mother, without washing their hands.  Once hand washing in between deliveries was made mandatory, the incidence of infection and death in newborns plummeted.

      Why wasn’t this simple and common sense solution instituted earlier?  Was it ignorance, negligence, laziness, or a combination thereof that kept doctors from washing up?  Whatever the root cause of this ridiculous oversight, it remains a fact of history.  Common sense was finally employed, and babies’ lives saved.

     The same common sense is at play in the development of the FDA’s Hazard Analysis Critical Control Point (HACCP) policy, which was developed to ensure the safe production of commercial food products.  Like the observant nurse who played watchdog to doctors’ poor hygiene practices and became the catalyst for improved hospital procedures set in place and remaining until today, HACCP policy results in a proactive strategy where hazards are identified, assessed, and then control measures developed to prevent, reduce, and eliminate potential hazards.

     In this article, we’ll begin to explore how engineers design food processing equipment and production lines in accordance with the seven HACCP principles.  You will note that here, once again, the execution of common sense can solve many problems.

     Principle 1:  Conduct a hazard analysis. – Those involved in designing food processing equipment and production lines must proactively analyze designs to identify potential food safety hazards.  If the hazard analysis reveals contaminants are likely to find their way into food products, then preventive measures are put in place in the form of design revisions.

     For example, suppose a food processing machine is designed and hazard analysis reveals that food can accumulate in areas where cleaning is difficult or impossible.  This accumulation will rot with time, and the bacteria-laden glop can fall onto uncontaminated food passing through production lines.

     As another example, a piece of metal tooling may have been designed with the intent to form food products into a certain shape, but hazard analysis reveals that the tooling is too fragile and cannot withstand the repeated forces imposed on it by the mass production process.  There is a strong likelihood that small metal parts can break off and enter the food on the line.

     Next time we’ll move on to HACCP Principle 2 and see how design engineers control problems identified during the hazard analysis performed pursuant to Principle 1.

____________________________________________

Food Manufacturing Challenges – Cleanliness

Monday, October 3rd, 2011
     My wife and I have an agreement concerning the kitchen.  She cooks, I clean.  Plates and utensils are easy enough to deal with, especially when you have a dishwasher.  Pots and pans are a little more challenging.  But what I hate the most are the food processors, mixers, blenders, slicers and dicers.  They’re designed to make food preparation easier and less time consuming, but they sure don’t make the clean up any easier!  Quite frankly, I suspect the time involved to clean them exceeds the time saved in food preparation.

     Food processors on a larger scale are also used to manufacture many food products in manufacturing facilities, and being larger and more complicated overall, they’re even more difficult to clean.  For example, I once designed a production line incorporating a dough mixer for one of the largest wholesale bakery product suppliers in the United States.  A small elevator was required to lift vast amounts of ingredients into a mixing bowl the size of a compact car.  Its mixing arms were so heavy, two people were required to lift them into position.  It was also my task to ensure that the equipment as designed was capable of being thoroughly cleaned in a timely and cost effective manner.

     Food processing machinery must be designed so that all areas coming into contact with ingredients can be readily accessed for cleaning.  And since most of the equipment you are dealing with in this setting is far too cumbersome to be portable, the majority of the cleaning must be cleaned in place, known in the industry as CIP.  To facilitate CIP, commercial machinery is designed with hatches and special covers that allow workers to get inside with their cleaning equipment.  Small, portable parts of the machine, such as pipes, cutting blades, forming mechanisms, and extrusion dies, are often made to be removable so that they can be carried over to an industrial sized sink for cleaning out of place, or COP.  These potable machine components are typically removable for COP without the use of any tools and are fitted with flip latches, spring clips, and thumb screws to facilitate the process.

     Everything in a food manufacturing facility, from production machinery to conveyor belts, is typically cleaned with hot, pressurized water.  The water is ejected from the nozzle end of a hose hooked up to a specially designed valve that mixes steam and cold water.  The result is scalding hot pressurized water that easily dislodges food residues.  Bacteria doesn’t stand a chance against this barrage.  The water, which is maintained at about 180°F, quickly sterilizes everything it makes contact with.  It also provides a chemical-free clean that won’t leave behind residues.  Once dislodged, debris is flushed out through strategically placed openings in the machine which then empty into nearby floor drains.

     As a consequence of the frequent cleanings commercial food preparation machinery requires, their parts must be able to withstand frequent exposure to high pressure water streams.  Parts are typically constructed of ultra high molecular weight (UHMW) food-grade plastics and metal alloys such as stainless steels, capable of withstanding the corrosive effects of water.  And since water and electricity make a dangerous combination, gaskets and seals on the equipment must be tight enough to protect against water making its way into motors and other electrical parts.

     Next time we’ll look at how design engineers of food manufacturing equipment use a systematic approach to minimize the possibility of food safety hazards, such as product contamination.

____________________________________________

Food Manufacturing Challenges – Look and Taste

Sunday, September 25th, 2011
     Ever wonder why the burger you get at your favorite fast food chain never looks like the one on TV?  The bun isn’t fluffy, the beef patty doesn’t make it to the edges, and the lettuce is anything but crisp.  Well, it’s because a professional known as a Food Stylist, working together with a professional marketing firm and production crew, has painstakingly created the beautiful, bright and balanced burger used to lure you in.  The process can take days or even weeks to create and has nothing to do with reality.  The burger you’re really going to get will look more like a gorilla sat on it.

     Many of the same issues must be dealt with when mass producing food.  Chances are human hands will never even touch the product, like they did when creating the prototype in the test kitchen.  In the world of food manufacturing, the “look” part can be extremely challenging.  How do you get machines and production lines to create visually appealing food that entices prospective buyers to make an investment in it?  How do you get it to taste good, or at least acceptable to the palate?

     The “taste” part of food manufacturing can be even more challenging.  For example, in the test kitchen of a pastry product manufacturer, a recipe will be developed using home pantry products like flour, butter, and eggs.  Ever made bread or a pie crust?  The stickiness factor is enough to drive many insane.  Even nimble human fingers have a hard time dealing with it.  Now enter food processing machinery and conveyor belts into the scenario.  This brings the possibility of stickiness to a whole new level.  Huge messes that gum up the machinery are common, and production line shutdowns are the result.

     When faced with these challenges, plant engineers have to work closely with chefs in the R&D kitchen to come up with some sort of compromise in the recipe or final form of the food product.  The goal is to cost effectively produce food products acceptable to consumers for purchase, and it’s often an iterative process involving many successive changes to recipes and equipment designs, coupled with a lot of testing and retesting, before success is finally met.  If testing ultimately proves that the product appeals to consumers’ tastes and flows nicely through production lines, then there’s a good chance it will be a commercial success.  In any case, cost is the dictating factor as to whether the food product will successfully make it onto the shelves of your supermarket.  A margin of profit must be made. 

     But this success is only part of the design process.  Before full commercial production can commence, processing equipment and production lines must be designed so that they:

  1. Are easy to clean at the end of the production run.
  2. Don’t contaminate the food during operation.
  3. Are easy to operate and maintain.
  4. Can be easily modified to make other products.

     Next time we’ll explore how cleanliness requirements factor into food manufacturing equipment design.

____________________________________________

Food Manufacturing Challenges

Sunday, September 18th, 2011
     Some people just have a knack in the kitchen, and my wife is among them.  She transforms raw ingredients into the most amazing culinary delights, almost like she’s waving a magic wand.  The finished products are works of art, hand crafted with tender loving care, and lucky me, I get to feast on them regularly!

     During the course of my engineering career I’ve been employed within many industries, and at one point I made the decision to leave the electric utility industry and enter into the world of food manufacturing.  I accepted the position of Plant Engineer with a wholesale manufacturer of baking ingredients and frozen pastry products.  My main responsibility was the design of food manufacturing equipment and their production lines.

     What I had expected to be a relatively straightforward process soon proved to be more challenging.  I was no longer working with hard metal as my raw material, that is, gears, nuts, and bolts, but a whole new arena of things described by adjectives such as gooey and pastey.  Engineers don’t typically create food products, and let’s face it, you probably wouldn’t want to eat anything that I cooked anyway!  But an engineer working within a food manufacturing plant must act as a liaison between the worlds of engineering design and the culinary arts.

     Now food manufacturers typically hire professional chefs to develop new products in their research and development (R&D) kitchens.  Like my wife, they’re well qualified to produce wonderful hand-made culinary delights.  The sticky part comes in when their small batch recipes and preparation techniques don’t translate smoothly to the world of mass production.  When it comes to handling food, human fingers are far superior to metal machinery, and raw ingredients behave differently for each.

     Herein lies much of the challenge for design engineers within the food industry.  How do you design equipment and production lines to make huge quantities of food that look and taste as good as the prototype products made by hand in the R&D kitchen?  Next week we’ll find out.

____________________________________________