Commemorating Five Years of the America Invents Act

On Wednesday, September 21, members of Congress and key congressional staff, USPTO leadership, and stakeholders from industry and the inventor community came together again to commemorate the 5th anniversary of the AIA on Capitol Hill.  What follows is a guest blog by Dana Robert Colarulli, Director of the Office of Governmental Affairs that appeared on the Director’s Forum Blog on the USPTO website. Enjoy!

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“We’ve come a long way in five years. The Leahy-Smith America Invents Act (AIA), signed in 2011 by President Obama, modernized the U.S. patent system and, as a result, helped strengthen America’s competitiveness in the global economy. Together with our stakeholders, the USPTO sought to implement the act consistent with the intent of Congress to increase certainty in our nation’s intellectual property (IP) landscape and enable the brightest ideas and most ambitious endeavors in the world to come to light.

I was there in 2011 and the years leading up to the President signing the AIA and have watched the agency embrace and implement the numerous provisions in the act. On Wednesday, September 21, members of Congress and key congressional staff, USPTO leadership, and stakeholders from industry and the inventor community came together again to commemorate the 5th anniversary of the AIA on Capitol Hill.

The event featured remarks from USPTO’s Director Lee, Representative Lamar Smith and Senator Patrick Leahy on the history of the AIA, the need for change, and the AIA’s impact on the IP system – even as we continue to evaluate these sweeping changes and look for ways to further improve our system. A panel discussion at the event focused on the impact the act has had on businesses and inventors of all sizes and what may be next in the way of improvements to the patent system.

The AIA implemented a number of significant changes to update and improve the U.S. patent system.  Upon signing the bill in 2011, the President described what the bill hoped to accomplish this way:

“It’s a bill that will put a dent in the huge stack of patent applications waiting for review. It will help startups and small business owners turn their ideas into products three times faster than they can today.  And it will improve patent quality and help give entrepreneurs the protection and the confidence they need to attract investment, to grow their businesses, and to hire more workers.”

The USPTO has delivered on that promise by reducing the patent application backlog by nearly 30 percent from its high in early 2009, speeding up examination including introducing a fast track option with discounts for small entities, and leveraging the increased financial stability and fee setting authority provided by the act to reinvest user fees into increasing quality under Director Lee’s Enhanced Patent Quality Initiative.

And just this week, the USPTO and the Economics & Statistics Administration at the Department of Commerce released an updated report on the impact of IP on the U.S. economy, reiterating in quantifiable terms the importance of a well-functioning IP system.

The increased attention and focus on our IP system in recent years is critical, and our job to look for ways to further improve did not end with the AIA. Again, the President stated in 2001:

“And we have always succeeded because we have been the most dynamic, innovative economy in the world. That has to be encouraged. That has to be continued.”

Inventors and innovators in the U.S. and around the world deserve a system that evolves and improves right along with the pace of technology – an important reminder as we celebrate the 5th anniversary of the AIA.”

Learn more about the impact AIA has had over the last five years in:

In Search of Prior Art

By Debby Winters

A question that is often asked by new inventors is:  should I do a prior art search before filing a patent application?  The answer, as in most areas of law and life in general, is that it depends. This is the first of 2 parts on prior art searches. In this post I will discuss why you should do a prior art search before preparing and submitting your patent application.  In the 2nd part I will discuss how to go about having a prior art search done.

For individual inventors and smaller companies including start-ups, I would suggest that you should do a prior art search.  Many larger companies have a number of scientists and technologists who are familiar with the technology and what their competitors are doing.  They can also absorb the potential risks of not doing a prior art search.  Most small entities and start-ups do not and cannot. Even so, a prior art search just makes good sense!

Many, if not most, new inventors are convinced that they are the only ones that have thought of the idea that they seek to patent.  They believe that they have had a flash of insight that no one else has had.  They may even do a bit of Internet research to convince themselves that they are in the clear and that there is no need to do a prior art search.  They are often surprised by the results when they do have a search conducted.

The risks of not doing a search are several.

First, and most importantly, if you plan to commercialize or market the invention as a product or service, you don’t want to get slapped with an infringement lawsuit right out of the gate.  These suits are extremely expensive even if you don’t get hit with a large damage award.  There is a risk that you will not be able to afford to defend such a suit, and that all of your hard work in developing the invention, getting it through the prototype stage, and getting it to market would be wasted.  Usually, there is a significant monetary and time investment involved with these steps.  There is also a risk that a court could issue an injunction that would prohibit you from making, using, selling, or offering the invention for sale.

Second, conducting a prior art search prior to preparing a patent application may make prosecution of the application more efficient and cost-effective.  By knowing the closest prior art, the patent application and the claims may be prepared more strategically to take advantage of areas of patentability.  Claims may be prepared that get close to the prior art without encroaching on it.  It may be possible to develop arguments and strategies for convincing the patent examiner that the invention is non-obvious.

You may find that the invention needs to be reconfigured to “design around” patents that are found.  This could add to the value of the invention and potentially give you a competitive advantage.  You may find, however, that someone else has a patent that directly prevents you from patenting your invention.  In such a case, you may determine whether to abandon your endeavor or seek to partner with or secure a license from the patent holder, or just to try get to market as quickly as possible.

The main disadvantages of conducting a prior art search are that it will cost some money and that any material prior art that is uncovered must be disclosed to the Patent Office during prosecution of any patent application that is filed for your invention.  The cost is usually not significant in the overall scheme of bringing a new product or service to market and preparing and prosecuting a patent application.  In fact, a good prior art search can make these endeavors more efficient.  Most patent applicants are looking for strong patent protection in which case it is not a disadvantage to bring prior art to the patent examiner’s attention.  This will permit the patent to be “vetted” over that prior art.

How do you know if your idea is truly new and can be patented?

By Debby Winters

Clients frequently come to me with the question “how do I know if my idea is truly new and can be patented?” The standard and easy response that you will get from most patent attorneys will probably be “hire our firm to do a patentability or prior art search and we can tell you” but in my opinion this is not the proper answer. I tell my clients that the answer is more complicated than that as there are many factors to consider, and all on a case by case basis.

While conducting a patentability search and a prior art search is extremely valuable, it is not the be all and end all that many patent attorneys portray it to be as many times there are key articles or other patents that are missed. This means that despite best efforts, and some very smart people using very expensive searching tools, it is nearly impossible to figure out if your idea is truly new or novel. Chances are that there is someone somewhere around the world who has invented the same thing or something very close to it. It’s very hard to find that out, even with advanced searching technology. However, the benefits you receive from the search can be valuable in many other ways.

But how do you truly know if your idea is new? The response I gave to this question is that you can’t ever know for certain but if you do a good patent search and combine that with an internet search using Google and other search engines that have large information databases, you can get a good feel for how new your invention is, BUT there are never guarantees. Hopefully this search will give you enough information to justify your patent filing but I would never bet any money that your idea is truly new or novel on the fact that a patent search did not find any identical inventions. My basic premise is always that the lack of finding something does not prove that it does not exist.

The patent search before you file your patent is your first indication of how new your idea may be. The second test will come as you go through the patent prosecution process and the US Patent Office will do its own search. Usually that search will pick up a few things that your professional search missed. Most of the time you can convince the patent examiner that your idea is different from the similar inventions that their search found.

The last and final test will be a “cease and desist” letter or a lawsuit saying that you are infringing on the patent someone else already has. This is often scary for people to hear but the good news is that if you are successful enough to get these types of letters then this usually means your invention is doing well in the marketplace and you should have enough money to defend your patent.

The bottom line is there is so much information out there and so many people doing so many things around the world that it is nearly impossible to know if any idea is truly new and novel. The best we can hope for is a good enough patent search upfront to help us draft our patent in a way that will get it allowed by the patent office. Nobody truly knows if their invention is new and novel until either the patent office certifies that it is with an issued patent, and even then the patent office may have missed something.

A Prior Art Search…to do or not to do?


By Debby Winters

Many individual inventors and small start-up company entrepreneurs ask if they should do a prior art search, or if they can forego that and save the money for the patent application itself. This is a tricky question to answer as many start-ups don’t have a lot of money BUT, the risk of filing the patent application when the invention might not be patentable could be costly too. Therefore, I usually recommend conducting the prior art search, but the timing of doing so might be important.

Many new inventors are surprised that they are not the only ones working on the same or a similar invention. The internet research they do, although limited, may convince them that they are the only ones working to solve this problem. A thorough prior art search is the only way to know for sure.

Think about the risks of not doing the prior art search prior to filing the application.

1-     The possibility of getting hit with an infringement lawsuit might be the mostly costly risk. These suits can be extremely expensive, even if you don’t get hit with a large damage award. There is a risk that you will not be able to afford to defend such a suit and that all of your hard work in developing the invention, getting it through the prototype stage, and getting it to market would be wasted. There is usually a significant monetary and time investment involved with these steps. There is also a risk that a court could issue an injunction that would prohibit you from making, using, selling, or offering the invention for sale.

2-     The prior art search can help in preparation of the patent application and potentially keep down costs during the prosecution stage. By knowing the closest prior art, the patent application and the claims may be prepared more strategically to take advantage of areas of patentability. Claims may be prepared that get close to the prior art without encroaching on it. It may be possible to develop arguments and strategies for convincing the patent examiner that the invention is non-obvious based on the prior art you uncovered. If you don’t do the prior art search prior to filing you won’t have this information under your belt when the examiner brings it up. Besides, if you find a patent that prevents you from obtaining yours, you can always consider licensing the technology you need to still market your invention. Better to find out now rather than later.

Many times inventors complain that anything you uncover that is material to the invention must be disclosed to the Patent Office. While this seems like a disadvantage, the patent examiner will find this anyway. The patent examiners are very good at finding relevant, as well as irrelevant prior art. A route I typically recommend is to file a provisional patent application, which costs much less than a full utility application, to claim your priority date. You then have time to do the prior art search and ensure that you want to move forward. This also gives you the opportunity to raise more capital to pay for the regular application and the opportunity to draft the application to “work around” any pesky prior art.

If you have questions, please feel free to contact me. As a licensed patent attorney, I will see how I can help.

Should I file my patent application before the new law goes into effect?

By: Debby Winters

The answer to this question might be yes. If you have any of the numerous activities that will be considered “prior art” under the new law but which isn’t considered prior art under the current law, then you should file before March 16, 2013. The new law contains many provisions that dramatically expand the prior art the U.S. Patent Office can use to determine whether an invention is patentable in the United States. Currently, prior art includes evidence showing that the invention disclosed and claimed in the application was sold, offered for sale, or in public use more than one year prior to the filing of a patent application, but only if that activity occurred in the United States. Starting March 16, any sale, offer for sale, or public use the invention anywhere in the world more than one year prior to the filing of a patent application is considered prior art, rendering the invention unpatentable in the United States. If you are in a situation like this, consider filing a provisional patent application now. You are not required to wait a year before filing the utility application but if you file before March 16, 2013 you can claim a priority date under the current system rather than the new system.

Who Wins and Who Loses in the Myriad Genetics Latest Court Ruling?

By: Debby Winters

The legal battle over patents on a pair of genes linked to breast and ovarian cancers, the BRCA1 and BRCA2 genes, took a twist recently with a ruling from a U.S. appeals court. This closely watched case for the health care and biomedical research industries signified a biotech industry partial victory when the court ruled that Myriad Genetics’ patents on the genes that are from mutations associated with a higher risk of cancers are valid.
To understand what this case is all about, let’s take a look at the real crux of the case, which is whether the genes represent natural occurring sequences.
A gene patent is a patent on a specific isolated gene sequence, its chemical composition, the processes for obtaining or using it, or a combination of such. Gene patents may claim the isolated sequences of genes, the use of the sequence for purposes such as diagnostic testing, or a sequence that has been altered by making changes to make it more useful.
The landmark case determining what is patentable is the 1980 case of Diamond v. Chakrabarty. Here the U.S. Supreme Court upheld the first patent on a newly created living organism, a bacterium for digesting crude oil in oil spills. The patent examiner had rejected the patent because it was from a living organism since, as a rule, raw natural material is generally rejected for patent approval. But Chakrabarty appealed this decision all the way to the Supreme Court, which ruled that as long as the organism is truly “man-made,” such as through genetic engineering, then it is patentable. Because the DNA of Chakrabarty’s organism was modified, it was patentable. Ever since this 1980 case, we’ve been struggling with what is naturally occurring and what is made-made.
The current case started in 2009 when the Association for Molecular Pathology, the American Civil Liberties Union, the Public Patent Foundation (and others) sued Myriad Genetics of Salt Lake City challenging the validity of Myriad’s patents on the two genes saying the genes were naturally occurring. The suit alleges that Myriad’s sole rights to the genes and its diagnostic analysis of them leaves women unable to get a second opinion or to confirm their test results elsewhere. Additionally, many cannot afford Myriad’s $3,000 screening.
In 2010, a lower court in New York invalidated the patents, ruling that they were barred by laws preventing the patentability of natural phenomena. Myriad then appealed to the U.S. Court of Appeals. This court ruled that the patents on the genes themselves are valid “because each of the claimed molecules represents a nonnaturally occurring composition of matter.” This reasoning assumes that the patents are based on “nonnatural” segments of DNA extracted from cells, not on the DNA itself as it occurs in the nucleus. Contrary to the view of a lower court, this court ruled that a method of screening for potential cancer therapeutics by tracking their effects on cell growth rates is patentable. However, the company’s claims on testing for cancer risk by comparing or analyzing DNA sequences was deemed invalid. The reasoning behind this is that the methods are based on “abstract, mental steps” of logic that are not “transformative.”

Wide-reaching impact

The decision means a victory for both sides. While it  is not likely to fully satisfy either of the battling parties, most biotech companies may be relieved to learn that the court did not completely wipe out the gene patents. Myriad’s attorney said “It’s a win because much of the value associated with DNA-based or -implicated inventions, ranging from diagnostics to therapeutics, would be eviscerated if the court determined that the DNA claims were not patentable.”  On the other side an ACLU attorney said “Human DNA is not a manufactured invention, but a natural entity like air or water. To claim ownership of genetic information is to unnecessarily block the free exchange of ideas.”
Others against the ruling claim that Myriad’s exclusive control over the gene sequences precludes improved genetic tests while those in favor of the ruling claims that gene patents promote innovation and lead to more scientific discoveries.
The case is far from over. The plaintiffs have the option of asking the panel for reconsideration, requesting a review by the entire appeals court or appealing the case to the U.S. Supreme Court. Like Diamond v. Chakrabarty, I expect to see this one go all the way to the Supreme Court.