Biotech and Medtech - Inventions & Patents

In designing medical devices or developing new products in the biotech industry, patent review is part and parcel of the due diligence process prior to committing resources into a project. Increasingly the engineers or scientists either by themselves or in consultation with IP professionals, have to make some kind of freedom-to-operate determination. Often times such decisions are subjective. The recent ruling by the United States Court of Appeals for the Federal Circuit on “willful infringement” could make things a little easier for the engineers and scientists…. 

This ruling revolves around the concept of “willful infringement” whereby the infringer is shown to have a willful intent to infringe. If “willful intent” is proven then the court can award punitive damage which is a discretionary award of up to three times actual damages. This is distinct from the case in which infringement occurred on the basis of carelessness on the part of the infringer.

For the past 24 years the standard for “willful infringement” required the patent owners merely to show that the infringer knew about the patent and failed to take the necessary step to avoid infringement. This standard has shifted towards a higher burden of prove when the United States Court of Appeals for the Federal Circuit ruled on some discovery issues (process of collecting evidence before trial) from a patent infringement case brought against Seagate by MIT and Convolve. With this new ruling, the proof of “willful infringement” now requires proof that an accused infringer “acted despite an objectively high likelihood that its actions constituted infringement of a valid patent”

This recent ruling means that scientists and engineers involved in developing new products have a little more room to maneuver. On the other hand, patent owners will have a more difficult task of proving “willful infringement” to collect punitive damages.

Links:

You can read the whole decision here.

The patents involved in the lawsuit are:

US 4,916,635

US 6,314,473

What did Wall Street Journal said?

These days the ability of the surgeon to perform complex surgical procedure is highly dependent on the support he can get both in terms of technology and support staff in the operating room.  So he needs to communicate with his supporting machines such as computer aided surgical navigation and his support staff in a clear and efficient manner.

One key support staff in the operating room is the scrub nurse.  This person manages and hands the surgeon the correct surgical tools at the right time in the course of the surgery.  Ideally, the surgeon keeps his eyes focused constantly on the operative site which may be an open wound or video display.  If the surgeon looks away from the operative site each time he needs a different instrument or re-set the supporting machines, he losses is concentration including slowing the flow of his surgical maneuver and having to refocus at the operative site.  The surgeon communicates with the scrub nurse using hand gestures.  So when a surgeon needs a pair of scissors, he would continue to keep his eyes focused on the operative site and simply put his arm out with the index and middle finger in a V sign configuration.  Then the surgeon would open his hand and the scrub nurse will “slap” the handle of the scissors into his palm.  The “slap” is for the nurse to indicate to the surgeon that as soon as you feel the “slap” I am going to let the instrument go. 

However this is a dying art for two reasons.  Surgeons and scrub nurses are not these days trained to communicate in this fashion.  Particularly, scrub nurses are often times rotated amongst different surgeons and thus there is not sufficient time to establish such “channel of communication”.  More importantly with blood borne transmission of infectious disease such as AIDS and Hepatitis, this manner of passing sharp instruments are at high risk of inflicting accidental lacerations.  The current practice of passing sharp instrument between surgeon and scrub nurse is to place the sharp instrument in a “passive dumb” container such as a metal K-basin.  This way the surgeon or scrub nurse will pick up the sharp instrument from the intermediary container.

But hand gestures in the operating room is not dead yet.  In October last year, I wrote a piece on Apple’s patent titled “Multi-functional hand-held device“.  Apple is coming back with a vengeance and this time it has an even greater implication for the medical device industry.

The patent of interest is the recently published patent application (August 2, 2007) titled “Multi-Touch Gesture Dictionary” with Apple Computer, Inc as the assignee.  It is interesting to note that the inventors in both patents are different.  The concepts are similar in that for “Multi-functional hand-held device” the hand gestures are captured by the co-ordinate system on the touch screen, whereas in “Multi-Touch Gesture Dictionary” the hand gesture can captured by a touch screen or built-in camera on the computer.  The patent application refer to the input device as “multi-touch interface” without specifically limiting itself to touch screens or camera.

A key claim in the “Multi-Touch Gesture Dictionary” patent application revolves around the concept of a “chord” that will trigger a series of options which is called “dictionary” in the patent application.  The desired option is then triggered by a specific motion of the hand gesture.  If you think about this for a minute, this is nothing more than a drop down menu system.  Just like fingering a guitar chord with a combination fingers, the “cord” is a combination of digits presented to the “multi-touch interface” (input device).  So instead of clicking on a menu item to show a drop down menu, this invention claims that a specific “dictionary” (drop down menu) will be displayed when “multi-touch interface” (input device) identifies a certain combination of digits (“chord”).  The combination of the “chord” and “chord” motion will select “meaning of a gesture” (i.e. specific item on the drop down menu).

Other features in the claims of this patent application include:

1. the “dictionary” will show “a motion and a textual description of a corresponding meaning” (i.e. a specific action to be triggered)
2. animation of gesture motion
3. visual and audio feedback.

What does this mean for the medical device industries?  The greatest value to the medical device industry is if this invention can be implemented in a practical way using an image capture system such as a built in camera.  This way we can get rid of all the handheld controls which are bound to get lost in the operating room environment and more importantly handheld controls will need to be sterilized if the surgeon is going to use them in the operative field.  As with any image capture system, line of sight will be an issue as it is often crowded in the operating room with personnel and machines.

As you can see in some of the links below, controlling appliances and computers by hand gestures is not new.

Other links

Hand Gesture TV Remote

Hand-gesture control

Apple’s Gesture Dictionary, a Fingering Chart for Multi-Touch

 

 

My bioengineering design class for third year bioengineering students is starting next Monday. I am going to select a series of blog entry I have made in the past which I consider to be of interest to do those in medical device design.

1. A new class of 3-D printers is going to change the design process for medical devices.
2. Websites you need to know.
3. Mother Lode of Health Care Information.
4. Learning from your competitors’ mistakes.
5. Looking for medtech info?