Biobanks Conference - Patent Rights Workshop

By Elizabeth Gearhart, Ph.D., Patent Agent at Gearhart Law
www.GearhartLaw.com 

 

When a person donates their body to science after death, where does it go? It goes into a bank, called a ‘biobank’, where researchers can make withdrawals and use the appropriate biological samples and data for their research. While this may sound a bit morbid, biobanks serve an important function in helping researchers find cures for diseases. If you’re taking any medication at all, chances are the medication was researched and developed using withdrawals from a biobank. So what are the rules and challenges for biobanks?

European researchers and service providers who work in this industry are gathering for a conference in Helsinki Finland to discuss the industry and rules.  The conference is hosted by the National Public Health Institute of Finland. Starting on September 24th, the conference is titled:

HandsOn: Biobanks 2014
From Biobanks to Medical Innovations

http://www.handsonbiobanks.org/2014/

The agenda includes plenary sessions and interactive platforms, including a workshop on September 26th where Patent Attorney Susanne Somersalo, Ph.D., Esq., of Gearhart Law will participate as an expert bringing a US view into the discussion, because after all European researchers want to protect their inventions in the United States too.  The workshop is titled:

“The future and reality of biomedical patents – de minimis that biobanks should be prepared for?”

 

Susanne will be discussing the challenges in obtaining patents in this area, such as:

1) What is patentable? The answer to that question depends, as the U.S. courts continue to issue rulings on what constitutes nature (not patentable) and what constitutes human-made, in their opinion (patentable).

and

2) What patent rights do biobanks have? For instance, if a Finnish biobank supplies samples to a researcher who is using an NIH grant to conduct his/her research, who owns the patent rights?

If you’re an entrepreneur in the life sciences field, this is of importance to you. For more information, you can email Susanne directly at Susanne@gearhartlaw.com

 

A Way to Defeat a Troll - Inter Partes Review

 written by James Klobucar, Esq., Patent Attorney at Gearhart Law
www.gearhartlaw.com

Review This….

 

            Inter partes review may be a term many are not familiar with but it can be used as an instrumental tool in protecting one’s self and business. 

            Inter partes review was given life by the America Invents Act (AIA) signed into law back in 2012. This procedural maneuver enables a third party to challenge the validity of an issued patent. It was designed to be a quick and efficient mechanism for challenging an issued patent as opposed to the overtly costly litigation route. Inter partesreview proceedings are administrated by the Patent Trial and Appeal Board (PTAB). The proceedings are presided over by a panel of administrative law judges who ultimately issue a decision on patentability of the contested patent at the conclusion of the inter partesreview. Any party dissatisfied with the final decision may appeal directly to the Federal Circuit Court.

            One such proceeding instituted recently (August 25, 2014) involves Space Exploration Technologies Corporation (SpaceX) headed up by former PayPal founder Elon Musk, and Blue Origin, LLC led by Amazon founder Jeff Bezos. The focus of the proceeding is patent 8,678,321 granted to Blue Origin, which interestingly enough is entitled “Sea Landing of Space Launch Vehicles and Associated Systems and Methods.” The patent focuses on reusable rocket technology, which many, including Musk, believe is the key to affordable space travel for the mass populous. Generally speaking, the focus of the patent is a rocket booster that once jettisoned can return in a controlled landing and subsequently be reused thus saving a vast amount of resources and money.

            SpaceX contends that Blue Origin’s patent should be invalid given the prior art, or patents and patent applications, available at the time of issuance and that it gives nothing new to the world of rocketry. The patent, itself, is broad and contains very little detail on how Blue Origin hopes to achieve a reusable rocket. SpaceX contends the patent is essentially, “it goes up, and then it comes down.” Thus, sparking this proceeding.

            Now, in order to institute an inter partes review, one must put forth a reasonable likelihood that the petitioner (challenger to the validity of the patent) would prevail with respect to at least one of the arguments put forth. The standard necessary to invalidate a patent is by a “preponderance of the evidence.” Legally, this is a relatively low threshold and essentially means “more likely than not” or a 51% chance of success. SpaceX’s argument is that this patent teaches nothing new and therefore should have never been issued. They cite numerous patents and patent applications which they claim show and describe all of Blue Origin’s claims in the issued patent. There are many in the community who feel the same way and an oft expressed opinion is that the patent should have never issued in the first place.   

With this seemingly low threshold, there is a moderately good chance of success in invalidating this patent. Thus, if you are concerned about a competitor enforcing a “flimsy” patent against you, one can move to have it invalidated via inter partes review rather than ending up in a costly court proceeding. However, it is important to note that inter partes review is only available during the first year after one has been served with an infringement complaint.

            Further, inter partes review should be a useful mechanism for those battling so called “patent trolls” as this avenue can help prevent litigation and the overall lower threshold for invalidation noted above should make for a quick decision or settlement. Even yet, the claims, or the metes and bounds, of the patent are construed with a broader interpretation standard in an inter partes review than what one may find in a litigious courtroom. This again further bolsters the challenger’s position as opposed to a monetary driven litigation proceeding. A charge of infringement for a patent troll can now potentially quickly become a case of an invalid and unenforceable patent.

            Thus, one may use an inter partes review to seek an invalidation of an issued patent. The rules set forth by this review process are generally favorable to the challenger and can result in substantially less money spent than in litigation. This may be the right choice for the small business or sole proprietor looking to preserve their business and technology while limiting costs.

Further Reading:

http://www.uspto.gov/aia_implementation/bpai.jsp#heading-1

http://www.uspto.gov/aia_implementation/faqs_inter_partes_review.jsp

Alice vs. CLS Bank - An Abstract Decision About Abstract Ideas

written by David Postolski, Esq., Patent Attorney at Gearhart Law
www.GearhartLaw.com

On June 25 the United States Patent Office issued instructions for examiners to follow when examining claims to determine if the subject matter is eligible for patent protection in response to the Supreme Court decision of June 19, 2014 of Alice Corp. PTY ltd v CLS Bank International. Patent subject matter includes processes, machines, manufactures and compositions of matter as outlined in 37 CFR Section 101. Ineligible patentable subject matter includes abstract ideas, laws of nature or natural phenomenon. 

Reported as the decision to be the death of software patents, such conjecture is an exaggeration to say the least. The main question in Alice was whether claims to a computer implemented invention are abstract ideas and thus not patentable. Interestingly enough, the decision that was supposed to be the death of software patents never went into an analysis of what software is, nor what a business method is. The Alice decision instead, ruled that Alice's claims were deemed to be patent ineligible abstract ideas because the claims "generically recite computers in the claims and add nothing of substance to the underlying abstract idea” and a patent should ultimately not preempt “fundamental concepts i.e. ideas that are the building blocks of human ingenuity and modern commerce”. 

These instructions are supplements to the recently issued Mayo v Prometheus examiner guidelines except the Alice instructions focus squarely on a 2 part Analysis. 

The 2 part analysis requires examiners (and the federal courts) to 1st determine whether the claim recites or is directed to a patent ineligible concept such as an abstract idea. For example, in Alice, the abstract ideas were:

·        fundamental economic practices,

·        certain methods of organizing human activities,

·        an idea of itself,

·        mathematical relationships and formulas.

If the abstract idea is present in the claim the 2nd step follows. The 2nd Step involves the analysis of whether the elements of the claims or the combination of elements of the claim are sufficient to ensure that the claim amounts to “significantly more” than the abstract idea itself. For example, as outlined in the Alice decision, “significantly more” could include:

·        improvements to another technology or technical fields,

·        improvements to the functioning of the computer itself,

·        meaningful limitations beyond general linking the use of an abstract idea to a particular technological environment. 

Example of limitations that do not satisfy the “significantly more” standard include:

·        adding the words "apply it" with an abstract idea,

·        adding mere instructions to implement the abstract idea,

·        requiring no more than a generic computer to perform generic computer functions that are well understood, routine and conventional activities known in the industry.

The Alice instructions have already been applied by the Federal Courts. Case in point -Digitech Image vs. Electronic for Imaging (Fed. Circuit 2014). The Digitech invention involved the tagging of digital images with information about the camera and the cameras color/spatial image qualities. The claims were directed to the device’s data set profiles as well as a method for generating a device’s data set profile. The data set profiles were simply information about the cameras qualities.

The court applied the 2 step analysis and determined that the patent in question involved the following abstract idea: "creation of two data sets by taking existing information such as measured chromatic stimuli and spatial stimuli and organizing this information into a new form. “ The court held that the claim involved an "ineligible abstract process of gathering and combining data that did not require input from a physical device."    The court then looked to see if the patent claim provided that "something more" that would transform the result into something patentable and there wasn't. The court further held that the claim simply recites a "process that employs mathematical algorithms to manipulate existing information to generate additional information" and that in of itself is not patentable.

We write this column today as the fallout from the Alice instructions is also being felt outside of the Courts as well. The Patent Office has been canceling Notice of Allowances and pulling granted claims while citing the Alice vs. CLS bank decision. However, on August 4, 2014, USPTO Commissioner for Patents Peggy Focarino , stated that “this limited action was closely-tailored and taken specifically in reaction to the Alice Corp. decision. We do not anticipate further review of any applications indicated as allowable under this process, as examiners are currently following the Alice Corp. preliminary instructions during examination (i.e., prior to allowance).” We have yet to experience this first hand but rest assured, we believe that through the public comment period (which ended on July 31, 2014) and due to the difficulty involved in defining what is an abstract idea, any fall out will be met by all of us with swift resolution and detailed analysis. 

Apple Protects Its Intellectual Property In Multiple Ways

written by Susanne Somersalo, Ph.D., Esq., Patent Attorney at Gearhart Law
www.GearhartLaw.com

           A few days ago the headlines hit the news that Apple can now apply to trademark its retail store design in Europe. The European Union court said that Apple can register an image of its store layout as a trademark with the German Patent and Trademark Office, which originally denied Apple’s application. Because the court decision is valid in 28 EU member states Apple may get trademarks for the store design not only in Germany but in all the EU countries.

            Wait a minute, isn’t a trademark for a word or phrase or logo?  Like the word mark Apple® or the logo with the apple – a design that everyone knows? How can a retail store design be trademarked?

            Actually, a trademark may be any recognizable sign, design or expression which identifies products or services of a particular source from those of others. Thus it actually may be anything that makes the consumer draw the connection between the goods or services provided and the provider. Of course every country has its own standards to define when a sign, design or expression draws this connection.  The point is that when an entrepreneur is considering applying for a trademark for their business, they should consider every aspect of that business and what parts can be trademarked.

            In the United States there are several trademarks for store designs, colors, sounds, and even scents. In addition to the word and logo marks, Apple has successfully trademarked various designs and sounds in connection with its services and products. The store design was already trademarked in the United States in 2011. The US Patent and Trademark Office has deemed that the store design distinguishes Apple stores from any other stores. When a consumer sees the glass building, she knows it is an Apple®-store, not a Microsoft®-store or Starbucks® coffee shop.

            In order to protect every aspect of its store designs, Apple also has design patents for the building glass panels, and for the staircase design. 

            One may think that this is a little bit of an excessive approach to protect one’s Intellectual Property. However, this IP is worth of a fortune.

Net Neutrality and You

 

By: Matthew G. Miller, Gearhart Law

www.GearhartLaw.com

If you’ve been exposed to any media outlet recently, you’ve probably heard the phrase “net neutrality” being tossed around. While there are a number of descriptions available online (including my personal favorite), in short, net neutrality means that all data traveling through the “pipes” of the internet must be treated equally by internet service providers. Now this might seem reasonable to you, especially because it is the current law in the United States as well as in the European Union.

However, despite this seemingly fair system, the American telecommunications lobby is attempting to compel the Federal Communications Commission (the “FCC”) to allow for a two-tiered system. This system would allow for there to be two tiers of “pipes” throughout the internet; one for normal customers and another for customers who pay are capable of paying for the premium lane. Opponents of this system refer to the two-tiered system as providing a slow land and a fast lane while the two-tiered system’s proponents, characterize it as providing a fast lane and a hyperfast laneMany large companies such as Facebook and Google have spoken out against the implementation of this two-tiered system. In contrast, Apple has been mysteriously quiet as to their opinion on the proposed change.

 

What’s interesting to note here is that the telecommunications lobby is stating that end-users will not notice any increased cost in their service. This system would call for the owners of websites to pay for the premium channel. Perplexingly, this move is designed to promote competition, although how exactly competition will be promoted is unclear at this time.

That said, I’m sure you’re wondering “but what does this all mean for me?” and the answer, in typical lawyer fashion is that it depends. As a consumer, this implementation of this system would mean that some of your favorite services will run spectacularly well, while others will run at current speeds.

As an entrepreneur, this system means that being able to pay for the fast lane will become a serious consideration when determining your operating expense. You should consider how important speedy access to your website and other internet-based services is, and whether it is appropriate to cut other expenses to be able to afford to compete.

Fortunately, these questions need not be answered today as the proposed regulation is still merely a proposal. However, there are very large players on both sides of the issues, and the battle for an open internet is certainly not going to be a short one.

Overblown and Overhyped: A Legal Assessment of the Cancellation of the Washington Redskins' Trademarks

 

written by James Klobucar, Esq., Patent Attorney at Gearhart Law
www.GearhartLaw.com

As many have likely now heard, the United States Patent & Trademark Office (USPTO), namely the Trademark Trial and Appeal Board (TTAB), has canceled six trademark registrations owned by Pro-Football, Inc. and attributable to the “Washington Redskins” American football team of the National Football League (NFL). Each of the canceled trademarks bore the word “redskin” or some derivative in each of the trademarks.

Is this really a landmark decision as is being lauded by the media?

Firstly, it is important to note that this fight has been fought before. In 1999, the Trademark Trial and Appeal Board (TTAB) canceled six trademark registrations, the same registrations that were just recently canceled. However, this cancellation was overturned on appeal by a federal court over a decade later. The appeal ruling was returned in Pro-Football, Inc.’s favor because it was determined the individuals, or plaintiffs, who initiated the case waited too long to do so. 

The case, in this instance, hinges on two main legal principles: 1) whether the meaning of the word disparaged a substantial composite (which is not a majority) of Native Americans at the time the trademarks were registered and 2) whether the affirmative defense of laches, or an unreasonable delay in pursuing a claim, applies to the plaintiffs in this case. Note, the laches defense asserted by Pro-Football, Inc. was the legal technicality that caused the federal court to overturn the cancellation by the TTAB in the prior case noted above. This time around, in a split decision (2-1), the TTAB found that the meaning of the word disparaged a substantial composite of Native Americans at the time of registration and that the affirmative defense of laches does not apply to the current plaintiffs.

However, before you take to the streets and start printing and selling your “Washington Redskins” team gear, you would be wise to take the below into consideration.

As previously noted, this fight has been fought before. In 1999, the Trademark Trial and Appeal Board (TTAB) canceled the same registrations. The case was appealed and that appeal process took over a decade before the cancellation was overturned by a federal court. Throughout the entire time the case was on appeal, the federal registration for the trademarks remained in full force. The trademark attorney for the Washington Redskins has already stated that the team will appeal this new ruling, and during this new appeal process, the trademarks will, once again, remain in full force. 

Additionally, the cancellations are only directed to any trademark that uses the word “redskin” or any other derivatives. It in no way affects the team’s ability to use their logo or team name in any setting. Thus, the logo is and still will be protected under a federal trademark registration. The team can and will, barring any decision by team owner Dan Snyder, retain the team name and logo and be able to do so with no legal consequences.  

In turn, even with the cancelation, the Washington Redskins can still attempt to enforce their exclusivity to the trademark under federal law per §43(a) of the Lanham Act. Even further, if hypothetically, the appeal is filed and the cancellations are upheld, Pro-Football, Inc. would still possess common law trademark rights, which are distinct from federal trademark rights. There are a number of benefits to having a federal registration attributable to a trademark, including but not limited to, a legal presumption of ownership of the mark and the ability to bring an infringement action in federal court seeking statutory damages. 

However, absent such federal registrations, a trademark can still exist under common law regardless of the nature of the trademark. These common law rights provide for trademark rights within a certain territory based on a priority of use of the trademark(s) within that territory. It is incontrovertible as to the nature of the association between the trademarks currently owned by the Washington Redskins and the NFL and their territory of use in commerce. Regardless of the outcome of the appeal, the Washington Redskins and the NFL will be able to use the marks, under federal or common law rights, in commerce and prevent others from doing the same.

Thus, any sports fan or an individual who devises a “get rich quick” scheme or otherwise decides to produce and sell “Washington Redskins” gear without obtaining advance permission from the team, may create a false representation that it originated from the organization. That individual may subsequently be found to be in violation of improperly benefiting from the use of the trademark protected under at least common law and be forced to pay any and all damages related to their infringing use.

The morals, ethics, and so forth of the team name will continue to be debated and is a much murkier subject with no one answer. What is clear, though, is that the Washington Redskins will likely maintain their federal registrations for years to come (assuming they appeal the ruling), and even if lost, the team will still likely be able to prevent other uses of their trademarks under at least their common law rights. To answer the question:  Is this really a landmark decision as is being lauded by the media? Hardly.

Read the full opinion here:

http://ttabvue.uspto.gov/ttabvue/v?pno=92046185&pty=CAN&eno=199

After Mishaps in 2010, New Innovations are Being Brought to the 2014 FIFA World Cup Brazil

 

 

By: Matthew G. Miller, Gearhart Law

www.gearhartlaw.com

 

World Cup ball progression

 

You probably know that the 2014 FIFA World Cup Brazil kicks off this June 12. However, you might not know that a new soccer ball is created specifically for each World Cup. Now I know what you’re thinking, How does one develop a new soccer ball? Isn’t a soccer ball just a blend of polymers filled with air? At first blush I too was skeptical as to how must innovation the game of soccer can reasonably receive. That said, after looking into Adidas new soccer ball, the Brazuca, as well as the new goal-line technology being used this World Cup, my opinion was quickly changed.

The Brazuca (a Brazilian term used to describe that nation’s patriotism) is the result of a lot of effort by Adidas’ personnel. Jabulani, Adidas’ game ball for the 2010 World Cup, was very poorly received by the players in the 2010 World Cup because the ball moved erratically in the air. After this widespread criticism Adidas took extra efforts to ensure that the ball will be fit for competition this year, and for that reason Adidas has been testing the Brazuca for over 2.5 years. This makes the Brazuca the most tested soccer ball ever. Not only has the design of ball been well-vetted, but a great deal of care is involved in the production of the ball too.

The outer surface of the Brazuca is constructed out of a few different panels, where the panels are connected to each other by seams and each panel has pseudo-seams that extend, at least in part, over the outer surface of an adjacent panel. The layout of these seams allows the ball to behave predictably, both in the air and on the ground. Interestingly, the ball and its outer surface are protected by a number of different patents assigned to Adidas: U.S. Design Patent Number D697,150, U.S. Design Patent Number D696,738, and U.S. Patent Number 8,529,386 are all directed towards the technology that comprises the Brazuca.

Aside from the improvements that have been made to the ball, additional innovations are being brought to the 2014 FIFA World Cup. As mentioned earlier, 2014 will be the first World Cup to employ what is known as goal-line technology, (GLT). This new technology aids officials in determining whether or not a goal has been scored. GLT works by utilizing 14 high-speed cameras located around the soccer pitch, as well as an additional 7 cameras that are trained on the mouth of the goal. These cameras map the location of the ball in 3D space and notify the officials whenever a game ball has breached the threshold of the goal.

FIFA agreed to implement this technology after the English team was wrongfully denied a goal in their Round 16 match against Germany in the 2010 World Cup. In that game, replays indicated the Frank Lampard, a player on the English World Cup team scored a goal, but the officials failed to credit his achievement. That game resulted in a tie despite the fact that England should have prevailed.

Will the new innovations lead to a more fair determination of the greatest soccer-playing nation in the world? I cannot say for sure, but I certainly look forward to finding out.

Boom Boom Speaker - patent longevitiy

Boom Boom speaker by Binauric

written by James Klobucar, Esq., patent attorney at Gearhart Law
www.Gearhartlaw.com 

                                                                                                                                                                                                           

Inventing Outside the Box…or Speaker

           Binauric, a German based company, has created a new Bluetooth® enabled speaker called “Boom Boom” which can acquire new functionalities throughout its lifespan. Such technology is a breath of fresh air in our current technological revolution where a slightly larger display screen warrants a new iPhone® release and leaves one with outdated technology. The Boom Boom not only has the typical components one would expect to find in a speaker, but also incorporates many others including light sensors, accelerometers, and microphones. 

           The idea behind this mash up of parts is the speaker can be continuously updated to include such “dormant” functionality as technological applications arise. For example, the accelerometers could be employed to change the music being played with a simple shake of the speaker. Or the light sensor could silence the speaker when the lights go out. Such an approach is not only clever, but may result in a patent that is enforceable for years to come.

           Under United States patent law, a granted patent gives one protection for a term of 20 years from the earliest claimed filing date. Throughout the 20 year period, there are a series of incrementally increasing maintenance fees required by the US Patent & Trademark Office due at 3.5 years ($400-$1600), 7.5 years ($900-$3600), and 11.5 years ($1850-$7400) after issuance of a patent. Thus, it is important that the technology covered in the patent is economically viable in order to justify continuing to pay such fees. Often, inventors find that their invention is “outdated” after a number of years and thus do not pay the maintenance fees to keep the patent in force. This results many inventors receiving less than the 20 years protection afforded to them under U.S. patent laws, and subsequently having their former patented technology becoming part of the public domain.

            This brings us back to the Boom Boom speaker. The inventors, in this instance, thought “outside the box” in terms of what their invention can possibly bring to the table. Whereas many inventors fall into the trap of patenting and developing what their invention “is” and nothing more, these individuals saw potential in an untapped and unrealized market. This unique combination of components and latent functionality may be able to continually capitalize on and prevent others from obtaining a piece of this market. Thus, as an inventor, you should be asking yourself during the inventing process, “if someone had already patented my invention, how could I change it in a way to effectively bypass, or design around, the patent?” By looking at your invention from a competitor’s viewpoint, much information can be gleaned about the vulnerabilities of your invention to competition and the strength of your patent in the marketplace. 

            This manner of critical thinking enables inventors to find great potential outside of their original conceptualization in their inventive endeavors. The end result being the inventors have now captured a larger market share, and like the Boom Boom speaker, potentially added many months or years onto its economic viability. Depending on the particular invention, each day of patent protection can result in hundreds of thousands of dollars in revenue. It can’t hurt to extend your stay as a long as possible.    

Further Reading:

http://www.wired.com/2014/04/a-clever-wireless-speaker-that-will-evolve-over-time/

     

Google Tries to Trademark "Glass"

Written by Matthew G. Miller, Gearhart Law
www.gearhartlaw.com

 

Google, the Mountain View-based search giant, is preparing for the release of their hotly anticipated new product, Google Glass. Aside from promoting Google Glass through various publicity stunts, Google is also looking to protect their legal rights associated with Google Glass. The company has filed a number of patent applications pertaining to the technology contained in Google Glass. However, recently Google has turned their eye towards a new realm of protection; federally registered trademarks.

In 2012, Google filed for a trademark on the term “Google Glass” and now the search giant is looking to expand its protection by registering a stylized version of the term “Glass,” as shown below. 

 

                  

 

 

              Note that under federal law** (15 U.S.C. §1052(e)(1)) a trademark cannot be registered when it is “merely descriptive” of the goods on which on the mark is being used unless the term obtains what is known as “secondary meaning.” Without this secondary meaning it is impossible for a mark to obtain full trademark protection. Establishing secondary meaning indicates that even though the desired trademark is merely descriptive, the public still identifies the trademark with the goods the mark is intended to identify. An example of this is Kellogg’s All-Bran Cereal. While the mark “All-Bran” describes an aspect of the cereal, the general public thinks of Kellogg’s cereal and no other product or service when hearing or seeing the mark.

Because “glass” is a descriptive term, the United States Trademark Office has rejected Google’s application to register the word. In response to the Trademark Office’s rejection, Google has filed a staggering 1,928 page reply. Granted, the reply is only 24 pages of substance and 1,904 pages of examples of “glass” being used in connection with Google’s product, Google Glass.  These additional 1,904 pages of examples are provided in an attempt to show the Trademark Office that the public, upon hearing the term “glass” thinks of their product. If Google can establish this connection, they will have achieved secondary meaning for the term “glass” in connection with Google Glass. In further support of their argument that this trademark should be granted, Google argues that the term “glass” is not descriptive of their product since Google Glass contains only minimal amount of glass, and is actually made up mostly of metal and plastic.

 

 

Whether or not Google will prevail in their attempt remains to be seen, but it will certainly be interesting to watch where things go from here…

 

**In the United States, under common law principles, a party gets protection of their trademark simply by using it. However, registering your mark with the federal government provides many, many benefits. 

USPTO Issues New Guidelines in Light of New Supreme Court Precedent

Written by Matthew G. Miller, Gearhart Law
www.GearhartLaw.com

 

Over the past few years, the Supreme Court of the United States issued two seminal opinions on patent law: Association for Molecular Pathology v. Myriad Genetics (“Myriad”) and Mayo Collaborative Services v. Prometheus Laboratories (“Mayo”). Each of these cases grappled with what constitutes patent-eligible subject matter. Generally, Myriad discussed whether gene patents are allowed and Mayo discussed whether a patent on a treatment regiment is allowable. In Myriad, that court held that gene patents are allowable only if the gene does not naturally occur in nature. In Mayo, because the patent merely directed a practitioner to measure the levels of a particular metabolite and adjust the treatment dosage accordingly, the Supreme Court held that the patent-in-suit was invalid. That said, these summaries are a gross oversimplification of both Myriad and Mayo (which are long, and can be difficult to wrap one’s head around) and the cases themselves give little guidance on their practical implications.

Due to the lack of guidance from the Supreme Court, the United States Patent and Trademark Office (“USPTO”) issued new guidelines on what is patent-eligible subject matter for patent agents and attorneys. These guidelines are also long and can be difficult to wrap one’s head around, however the USPTO has offered a quick reference guide to distill some of the main points of the unabridged guidelines.

In short, the guidelines directs an Applicant/Examiner to walk through the flow chart below. Regarding the third question, the USPTO gives a list of factors that must be considered, in their totality, to arrive at the appropriate answer for the third question. These factors are summarized below the flow chart.

 

 

For Question (3)

Factors that weigh towards eligibility

 (claim does recite something significantly different)

Factors that weigh against eligibility

(claim does not recite something significantly different)

 

1. Product claim that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from something naturally-occurring.

1. Product claim recites something that appears to be a natural product and has a structure that reflects that.

2. Claim recites elements/steps that impose meaningful limits on claim scope beyond the judicial exceptions. (Claim is narrow enough so that others are not precluded from using idea entirely.

2. Claim recites elements/steps that impose meaningful limits on claim scope beyond the judicial exceptions, but are too generalized and overly broad.

               

3. Claim recites elements/steps in beyond the judicial exceptions that are more than nominally related to what is being claimed.

3. Claim recites elements/steps in addition to the idea/objecting being claimed that must be used or taken by others to be applied.

4. Claim recites elements/steps that are more than just general instructions to apply or use the idea/object being claimed.

4. Claim recites elements/steps that are well-understood and conventional.

5. Claim recites elements/steps that include a particular machine or perform a transformation of a particular article.

5. Claim recites elements/steps in addition to the idea/object being claimed, but add no meaningful limiting steps.

6. Claim recites one or more elements/steps in addition to the idea/object being claimed that add a feature that is well-understood and conventional.

6. Claim recites elements/steps that amount to nothing more than a mere field of use.

            As you can see, for many inventions determining whether it discloses patent-eligible subject matter can be challenging! In light of these rulings and their interpretation by the USPTO, it is advisable to consult with your patent professional about your patent strategy and available options.