“It’s never good news when your area of the law is on 60 minutes,” says Courtenay Brinckerhoff, partner at Foley & Lardner LLP at the 2013 AIPLA Annual Meeting. It’s no secret that the Association for Molecular Pathology v. Myriad Genetics case had more than its fair share of media buzz. The decision, holding that isolated DNA was not patent eligible, left many of us wondering how to best address the needs of our biotech clients going forward.
The main claims at issue in this case are the isolated DNA claims. Claim one is broad enough to cover naturally occurring DNA, and claim two is specific to synthetic DNA. In 2010, the district court came out with a decision holding that DNA was not patent eligible subject matter, which was a bit of a shock to us. Most of the rationale was focused on the idea that DNA embodies information, and regardless of what the actual molecule looks like, Myriad’s claim is for that defining characteristic. The case went up to the Federal Circuit where former chemist Judge Lourie held that technically the isolated DNA is different than natural DNA, because you have to break the covalent bonds to isolate the methylated gene. There were, of course, also policy reasons to uphold the claim like the reliance of the biotech industry on the USPTO already having granted these sorts of patents for nearly 20 years.
Many factors can influence prosecution strategies and decisions. For example, take a look at the chart below:
You do not have to look hard to find an example such as the one shown here. Over a period of about a year and a half, the applicant negotiated through a non-final action and then abandoned the application. The patent examiner assigned to the case on average issues a Notice of Allowance at approximately three years and five months. Might the applicant have obtained allowance had they hung on a little longer?
There is no way to know for sure whether the applicant could have achieved an allowance had they hung in, but it would have been helpful to know that the examiner was very experienced and likely had decision making authority. Such an observation would have given great insight into the fact that the examiner in question here has an overall allowance rate of nearly 70%. It no doubt would have also been helpful to know that after an interview in over 50% of cases, the next significant event following the interview was an allowance. In short, the statistical data shows that this was an experienced patent examiner who is interested in working with applicants and their representatives to identify allowable subject matter and issue patents where appropriate.
I have been preparing and processing patent applications for about fourteen years, primarily within the electrical, mechanical and software technologies. From my perspective, the issuance of restriction requirements seems to be somewhat random and inconsistent. It is often the case, in fact, that I do not get a restriction requirement when there might be a relatively good reason for one to be issued.
On the other hand, I have always heard that practitioners in the chemical and biotechnological arts suffer from a higher than average issuance of restriction requirements. I set this week to do a little research to see whether this assumption could be statistically validated using Patent Advisor Search Tool.
Restriction requirements are governed by MPEP § 806.06 . In a nutshell, a restriction requirement is to be issued by an examiner where there are multiple distinctly claimed inventions in one patent application and it would be overly burdensome for the examiner to go forward with one application. For patent prosecutors and their clients, restriction requirements represent a significant cost increase as splitting one patent application into several new applications results in the multiplication of fees and, often, loss of protection due to expense limitations. The pros and cons probably do depend on the technological context, however.
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Last week the United States Patent and Trademark Office (USPTO) announced in the Federal Register that it would modify the After Final Consideration Pilot Program (AFCP) to create an After Final Consideration Pilot Program 2.0 (AFCP 2.0). The goal of AFCP 2.0 is much the same as it was when the USPTO initially introduced the precursor AFCP. According to the USPTO, the goal of AFCP 2.0 is to reduce pendency by reducing the number of RCEs and encouraging increased collaboration between the applicant and the examiner to effectively advance the prosecution of the application. Thus, this can and should be viewed as part of the USPTO effort to continue to try and address the RCE problem.
AFCP 2.0 began on May 19, 2013 and will run through September 30, 2013. The USPTO says that any request for participation in the program must be filed on or before September 30, 2013. Of course, as is always the case, the USPTO left open the possibility that the pilot would be extended beyond that date.
EDITOR’S NOTE: An earlier version of the article below contained inaccuracies. It was erroneously stated that SPE Len Tran had not allowed any applications since 2008. As a supervisor he oversaw the work of Junior Patent Examiners and was the decision maker on hundreds of patents since 2008.
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There is a story circulating the Internet over the last few days about an alleged filing with the USPTO. I initially decided to ignore this for several reasons. First, it is impossible for me to believe that a patent attorney actually filed this with the Patent Office, although I could see it being put together for internal use as a cathartic exercise. Second, alleged filing is dated April 24, 2013, but still does not show in Public PAIR. Third, the Art Unit listed in the heading of the alleged filing is Art Unit 4188, which does not coincide with the Art Unit according to the final rejection (i.e., the final rejection comes from Art Unit 3752). Thus, I have my suspicions about the authenticity, but on Monday CBS News published an article discussing this alleged filing under the title The letter to the Patent Office you have to read. So the matter is now out in the open.
Perhaps this really was filed, who knows. If it was filed we will eventually be able to find a copy of the filing on Public PAIR. In the meantime I’m going to continue to refer to this as an alleged filing. Notwithstanding, here the colorful comments from the Remarks section, which seem to be the only thing that makes up the filing.
The Patent Office should be estopped from raising a § 112 (a) rejection after raising a § 102 or § 103 rejection in an earlier office action. 35 U.S.C. § 112 (a) states:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention
Logically, if the application does not describe an invention in terms that allows one skilled in the art to make and use it, then the Patent Office should not have sufficient information to suggest that the application is not novel or obvious. In order to determine something is not novel or obvious you first have to know what it is. I have no objection to the Patent Office putting a 35 U.S.C. § 112 (a) and novelty/obviousness rejection in the same Office Action, where the PTO explains that to the best of their understanding of the invention it would not be novel or obvious for the following reasons.
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