Another Section 101 lack of utility rejection bites the dust

As reported in today’s recap email, in Ex Parte GELFAND et al (Aug. 2, 2018), the Board reversed a lack of utility rejection. This continues a longstanding trend of the Board frequently reversing such rejections.

In rejecting the claims as lacking utility under Section 101, the Examiner had asserted that the claims were not supported by a specific, substantial, and credible asserted utility, or a well-established utility. For support, the Examiner relied on MPEP § 2107.01 B(C), which states that “[a] method of assaying for or identifying a material that itself has no specific and/or substantial utility” is not considered to have a substantial utility.”

On appeal, the appellant argued “The present invention relates to the field of nucleic acid detection” and that nucleic acid detection has numerous uses including diagnostic uses and research uses–a specific utility.

While acknowledging the Examiner’s cited MPEP section, the Board rejected the Examiner’s reasoning. That identifying the presence of target nucleic acid sequences is a method for assaying “a material that itself has no specific and/or substantial utility.”

According to Anticipat Research, this type of rejection (Section 101 – Lack of Utility) has a very high reversal rate. Over the past two years, the PTAB has reversed 14 of 19 of these rejections, a relatively incredible 74% reversal rate. This may stem from the rejection being applied less frequently with other rejections and Examiners hence not having much experience with properly applying it.

With a reversal rate so low for lack of utility rejections, when struggling with an Examiner with such a type of rejection, it may be helpful to go straight to the Board on appeal to overcome such a rejection.

PatCon8 Conference: State of Patent-Eligibility of Medical Diagnostics Not Good

The eighth annual PatCon hosted by the University of San Diego School of Law included a wide range of speakers and presentations. Perhaps due to the largely academic audience, participants openly disagreed on various points. But one point had almost universal consensus: patenting medical diagnostics in the US is very bleak due to patent-eligibility. And it’s unlikely to change any time soon.

Since the Supreme Court decided Mayo v. Prometheus in 2012, the USPTO has shown a sharp decrease in finding good diagnostics claims to be patent-eligible. One session in particular focused on this: “Patentability of Medical Diagnostics” on March 2, 2018. This panel included Dirk van den Boom, CEO, Juno Diagnostics, former CEO of Sequenom; Brian Sun, Director, Intellectual Property, Prometheus Laboratories;  Matthew Bresnahan, Partner-Elect, Wilson Sonsini; Donna Shaw, UC San Diego;  Prof. Joshua Sarnoff, DePaul University School of Law; Prof. Jeffrey Lefstin, Hastings School of Law. We report on this session.

First off, Matthew Bresnahan shared statistics of decreased allowance rates and decreased filings in the 1630 art units. Matthew stated that the problem with diagnostics claims is not getting allowed claims, but rather getting good claims that do not suffer from divided infringement issues. He pointed out that the lone example claim deemed patent-eligible in the USPTO’s subject matter guidelines has a divided infringement issue. As a solution to fixing the patent-eligibility of diagnostics, Matthew suggested that the USPTO provide a “good” example claim in the guidelines that is deemed patent eligible.

Next, former CEO of Sequenom, Dirk van den Boom, talked about his experiences of having the courts take away all his company’s core IP based on patent-ineligibility. It was not planned, according to him. It was also not pleasant.

At one point audience member Mark Lemley tried to maintain an “All is well at the USPTO” attitude by pointing out that overall filings and grants in tech center 1600 may be up. Even if such data exists, which it wasn’t immediately clear to this correspondent, panelists agreed that certainly the types of claims currently granted are much different/worse than previously or in other tech centers.

Prof. Joshua Sarnoff then talked about a need to study the effects of the US choosing not to prioritize the patenting of diagnostics the same way that other countries do. To Professor Sarnoff, whether the US is correctly pursuing this policy is somewhat beside the point. With the proper data of what the patent-eligibility conundrum of diagnostics is doing to the economy, patent stakeholders can be in a better to know what to do.

While this session raised important problems about diagnostics, the solutions seemed unsatisfying. Outside of providing another patent-eligible example claim in the USPTO guidelines and gathering more data, there was some discussion on amending Section 101. For example, IPO and AIPLA proposals to amend Section 101 were generally deemed unrealistic in today’s congressional climate. Perhaps a more narrowly tailored amendment. But overall, all the solutions discussed seemed overly hopeful to change the status quo.

One solution not discussed relates to waiting for appeals currently percolating up the system. This blog has pointed out that the PTAB is currently doing a great job of reversing Examiners in tech center 1600 on Section 101, compared to other tech centers. This suggests that these Examiner rejections are not supported by precedent, and so the Board overturns. If the Board is showing an increase in not finding support in the case law, Federal Circuit panels will likely also find this with other cases. As some other diagnostics cases come up to the Federal Circuit, perhaps it is possible that a case can be distinguished over Mayo but still falls within the area of patent-eligibility.

Below is a photo of Carter G. Phillips, who did a wonderful job of opening the conference.

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