IP Law Bulletin

Utilizing examiner interviews during the prosecution of a U.S. patent application can help expedite prosecution and reduce costs. Statutory permission for interviews is provided in 37 C.F.R. §1.133, and §§713 713.10 of the Manual of Patent Examining Procedure (MPEP) provide guidance for preparing for, conducting, and summarizing interviews.

The Eastern District of Virginia recently determined in Exelixis, Inc. v. Kappos that the USPTO has been miscalculating Patent Term Adjustment (PTA) in cases where a Request for Continued Examination (RCE) was filed after three or more years of pendency. The USPTO has for many years interpreted the statute governing PTA as immediately tolling the three year statutory period for the calculation of PTA upon the filing of an RCE, regardless of whether the RCE is filed before or after the three year mark. But, in Exelixis, the USPTO was ordered to calculate the PTA on a day-for-day basis when an RCE is filed after three years from filing regardless of what else occurs during the continued prosecution, i.e., the filing of an RCE after the three year mark has “no impact on PTA.” It is unclear at this time whether the USPTO will adjust their PTA calculation rules to adhere to the order generally, whether the USPTO will appeal to the Federal Circuit, or whether the USPTO will simply maintain the current practice. But, patent owners should consider auditing their portfolio with eyes for cases where an RCE was filed three or more years after the filing date. If the patent is within two months of issuance, the PTA can be challenged within the USPTO by filing a request for reconsideration under 37 C.F.R. 1.705(d). If the patent issued within the past 180 days, the owner can choose to challenge the ruling in the Eastern District of Virginia, under the precedent of Exelixis.

Now more than ever, care should be taken when drafting patent applications to avoid unintentionally narrowing the claims under the doctrine of claim scope disavowal.

The USPTO and the European Patent Office (EPO) will launch the Cooperative Patent Classification (CPC) scheme on January 1, 2013. The CPC effort has been years in the making and aims to harmonize U.S. and European classification of documents, namely patents. The CPC incorporates best practices of existing USPTO and EPO classification systems and is based on the European Classification (ECLA) system. The harmonization should improve searching at the USPTO and EPO by facilitating work sharing, yielding more consistent search results across patent offices, and facilitating the retrieval of documents by examiners at the USPTO and EPO. Patent applicants should correspondingly benefit from Examiners spending less time on searching and more time on substantive examination of applications, all while receiving more consistent search results across patent offices.

On May 22, 2012, the U.S. Patent and Trademark Office (USPTO) published final rules that: (1) expand the ability of the USPTO to obtain specimens or other information reasonably necessary for proper examination, (2) allow the USPTO to conduct a post-registration pilot program to assess the accuracy of the register, and (3) facilitate the USPTO with verifying the accuracy of identifications of goods/services on the register. The rules took effect on June 21, 2012.

In an August 6, 2012 order, Judge Webber of the Eastern District of Missouri confirmed the jury verdict, including the reasonable royalty damage award of $1 billion in Monsanto Co. v. E.I. DuPont de Nemours & Co., Civil Action No. 09-CV-686 (E.D. Missouri August 6, 2012) (Webber, D.J.). The award is the fourth largest jury award in a patent trial in U.S. history, and is especially surprising given that DuPont’s accused product had never been made available to the public.

While some biotechnology patent owners breathed a short sigh of relief on August 16, 2012, as the US Court of Appeals for the Federal Circuit issued the highly anticipated decision Association for Molecular Pathology v. Myriad Genetics, finding that DNA sequences are indeed eligible for patent protection, not all biotech innovators will be happy with the Myriad decision since certain diagnostic method claims were again struck down as ineligible for patent protection. The Federal Circuit’s application of the Mayo case to Myriad’s claims on diagnostic methods provides little guidance on how to draft such diagnostic claims to secure allowance and survive future patentability challenges. While it is clear that the claims must recite something "transformative," what constitutes a transformation in a diagnostic method remains to be elucidated. The final word on this subject may need to come from the Supreme Court.

On August 14, 2012, the U.S. Patent and Trademark Office (USPTO) published its final rules for implementing the Inventor’s Oath or Declaration provisions of the America Invents Act (AIA). The final rules take effect on September 16, 2012, with respect to any application filed on or after this date, regardless of any claim for priority. The final rules provide a great deal of detailed explanation and include the new text of the relevant C.F.R. sections, but below is a brief summary of significant changes implemented by the final rules.

As diagnostics, end-user sophistication, and mobile and web-based technologies grow, so does the likelihood that potential infringement is carried out across multiple users or entities, i.e., divided infringement. Divided infringement scenarios exist where a single entity does not perform every element of a claim, but rather different entities perform the different steps of a claim. This divided infringement scenario occurs frequently as customers begin performing critical steps in implementing technologies – for instance, a doctor performing a collection or diagnostic step or a server user modifying a webpage. The divided infringement defense has grown more popular in recent years, paralleling the rising importance of method claims used to describe cutting edge computer software, business method inventions, and diagnostic and therapeutic inventions in biotech. This is particularly relevant where companies have been able to strategically avoid claims by performing less than all steps of a method claim and having their customers or other entities perform remaining elements of the claim.

This month, on September 16, 2012, post allowance proceedings as defined by the American Invents Act (AIA) begin, including Inter Partes review (IPR), Post Grant Review (PGR), and Business Method PGR. A table comparing these different post allowance proceedings, as well as current Ex parte reexamination proceedings, can be found at the end of this article, following a discussion of the various proceedings.