The Manual of Patent Examining Procedure – Ignore It at Your Peril
The Manual of Patent Examining Procedure (MPEP) does not legally bind applicants, as do the patent statutes in the 35 USC and the rules in the 37 CFR. Nevertheless, the MPEP sets out how applicants and their applications will be treated by examiners and others at the USPTO. This provides important information to those who deal with the USPTO, guidance the ignoring of which can have significant consequences to applicants and patentees.
An example of how this can play out is found in a recent case involving patent term adjustments, H. Lundbeck A/S v. USPTO, (E.D. Va. July 19, 2024). Patent term adjustments (PTAs) are available to extend patent term in compensation for certain delays by the USPTO during prosecution. As noted in MPEP 2734(I), the calculation provisions are “complex,” involving not only the time the USPTO has taken for its actions, but also taking into consideration extensions taken and other delays caused by the applicant, which can offset the USPTO delays to reduce the patent term adjustment.
Lundbeck involved a PTA dispute for a patent issued to Lundbeck, a Danish pharmaceutical company, for a drug for treating PTSD. The USPTO initially calculated a PTA of 4 days when the patent was issued. Lundbeck filed a request for reconsideration of the PTA, asserting that it should be 134 days. The USPTO first recalculated the PTA as 58 days, then reduced the PTA to 0 days in another recalculation. The USPTO then denied Lundbeck’s second request for reconsideration, which sought a PTA of 91 days, and Lundbeck filed suit against the USPTO.
At issue in the suit were tables in Lundbeck’s filed PCT application specification that included grayscale in the headings, for example as follows:
The USPTO objected to the tables as violating 37 CFR 1.52 and PCR Rule 11.2, which require the application to be of sufficient clarity and having sufficient contrast so as to be easily reproducible. MPEP 608.01(I) provides a further gloss on this requirement, stating that legibility “requires a high contrast, with black lines and a white background,” and strongly discouraging use of gray lines or a gray background. Lundbeck submitted corrected tables without the grayscale, but only more than a year after national phase entry, in response to a formalities letter issued by the USPTO.
That year counted against Lundbeck in the PTA calculation, since the application was not in condition for examination until the corrected tables were submitted, and the delay constituted failure by Lundbeck to take reasonable efforts to conclude prosecution. Lundbeck argued that MPEP was not binding law, and that therefore the use of grayscale should not be held against it, but to no avail. While the court agreed that the MPEP is not binding law, the MPEP did put Lundbeck on notice that its use of grayscale put it at risk of having the USPTO object to the tables. The PTA remained at 0 days.
Here a seemingly minor defect in the application cost the patentee three months of patent term, in addition to the cost of fighting the PTA determination at the USPTO and in court. It makes clear the importance of having a knowledgeable representative to guide you through the patent process, someone who knows not just binding laws and rules, but also the less formal standards and norms, such as those set out in the MPEP. While the MPEP is not binding law, paying insufficient attention to it can result in undesirable outcomes.