PTAB Enters Sua Sponte Patent Eligibility Rejections

06 February 2018 PharmaPatents Blog
Author(s): Courtenay C. Brinckerhoff

We’ve written previously about ex parte decisions of the Patent Trial and Appeal Board (PTAB) affirming patent eligibility rejections that seem to be inconsistent with the USPTO’s Subject Matter Eligibility Guidance. Apparently, applicants should be wary about appealing any rejection of a diagnostic method claim, because the PTAB may enter sua sponte patent eligibility rejections even if the examiner did not make a § 101 rejection.

Ex Parte Patterson

The PTAB decision in Ex Parte Patterson, Appeal 2016-001355 (Nov. 30, 2017), is an example of such a case. The claims at issue were directed to in vitro methods of screening for cervical cancer.  Claim 1 is representative:

1. A method of predicting whether a subject has a cervical intraepithelial neoplasia (ON) lesion that is a CIN2+ lesion, the method comprising:
obtaining data from a labeled liquid sample of cervical cells in suspension from the subject, wherein the data are obtained by analyzing the liquid sample with a flow cytometric device and comprise per cell morphometric data and data selected from the group consisting of: per cell biomarker data, per cell DNA content data, and combinations thereof; and
predicting from the per cell morphometric data and from the data selected from the group consisting of: per cell biomarker data, per cell DNA content data, and combinations thereof; whether the subject has a CIN2+ lesion.

The Prior Art Rejection On Appeal

The Examiner had rejected the claims as being obvious over a combination of prior art references. The PTAB reversed that rejection, finding that “the Examiner has not established that the prior art methods would have provided the claimed means to distinguish cancerous cervical cells from normal cells,” and agreeing with the application that “the Examiner has not established a prima facie case that a skilled artisan would have a reasonable expectation
of success in predicting or determining the presence of a particular type of CIN lesion or a cancerous cervical cell using morphometric data obtained through flow cytometry.”

The New Patent Eligibility Rejection

The PTAB cited the Supreme Court’s Myriad decision for the proposition that its “finding of non-obviousness, … does not necessarily lead to the conclusion that subject matter is patentable eligible.” The PTAB applied the two-step analytical framework set forth in Supreme Court’s Mayo decision, and entered a new rejection under § 101.

The PTAB’s analysis under Mayo/Alice step 2 explains its non-obvious but still non-eligible determination:

Like the claims in Mayo, the manipulative steps of claim 1 on appeal “consist of well-understood, routine, conventional activity,” as shown by Ling and Basiji. ….

Neither does considering the above steps as an ordered combination add anything new to the law of nature that is not already present when the steps are considered separately. In this respect, we note that our conclusion that the Examiner has not shown claim 1 to be obvious over Ling and Basiji does not change our conclusion that claim 1 is directed to an abstract idea without sufficiently more to transform the claim into a patent-eligible application. ….  Here, Basiji shows that obtaining cell morphometric data via flow cytometry … is something routinely engaged in by the scientific community. (FF12-FF18.) The fact that such data can also be used to predict the presence of a CIN2+ lesion, despite lack of a reasonable expectation of success … does not transform the claim into a patent-eligible application of the natural correlation between cell morphometric data generally (as the claim requires) and cell biomarker or cell DNA content data and presence of a particular type of cervical lesion.

The PTAB noted that the claims did “not recite a new method of performing flow cytometry,” and the applicant did not assert that the flow cytometer used is “structurally distinguishable from [the prior art] imaging flow cytometer.”

Thus, the PTAB invoked 37 C.F.R. § 41.50(b) and entered a new ground of rejection.

A Victim Of Evolving Standards?

When the Appeal Brief was filed in this case, the Federal Circuit had not yet issued its decision in Arisoa, and many believed that a diagnostic method involving specifically recited, concrete method steps that was patentable over the prior art passed muster under § 101. This decision underscores the way patent eligibility standards have evolved over the past few years, and highlights the more difficult scrutiny that novel, non-obvious, and even “[g]roundbreaking, innovative, or … brilliant” diagnostic methods face today.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services