What information should an inventor submit to the USPTO to satisfy the inventor’s duty to disclose material information relating to the patentability of the invention?
The inventor should disclose references that teach specific aspects of the invention being claimed to the extent that the inventor knows of those references. The inventor has no duty to go out in search for particular references but only a duty to disclose. More broadly, the inventor may also want to consider disclosing references that show background knowledge about a particular technique, step, feature of the invention that a skilled artisan would have possessed at the time of filing the patent application. For example, if the claimed invention includes a particular technique or feature, then the inventor should consider submitting background information as to the extent of use of such technique. Otherwise, the patent may be held invalid for the patent owner’s inequitable conduct, namely, the inventor’s failure to disclose material information to the USPTO.
DUTY TO DISCLOSE
The duty to disclose information throughout the pendency of a patent application arises out of a broader duty of candor and good faith that one owes to the USPTO when seeking patent protection. The inventor and those involved with the filing of the patent application must disclose all information that it knows of which the examiner may use to reject the patent application.
In practice, inventors are unsure of what type of information should be disclosed to the USPTO. Normally, inventors instinctively understand that references that show a feature or step used in their invention should be disclosed to the USPTO. Generally, inventors should err on the side of disclosure since failing to disclose information that the inventor should have disclosed could lead to charges of inequitable conduct which may invalidate the inventor’s patent should one issue from the instant application. Nevertheless, typical disclosures are generally directed to disclosures of similar product features, techniques and steps.
CONSIDER DISCLOSING BACKGROUND INFORMATION TO SATISFY THE DUTY TO DISCLOSE
In Ariosa Diagnostics v. Verinata Health, Inc. (Fed. Cir. 2015), the Federal Circuit clarified the types of information that one should disclose to the Patent Office to satisfy one’s duty to disclose. Information regarding specific techniques, steps and product features should be disclosed. Additionally, background information regarding the specific techniques, steps and product features may also have to be disclosed. In Ariosa, the background information pertained to the extent or widespread use of a particular technique used in the claimed invention. The Federal Circuit believed that such widespread use would be relevant to the patentability of the claimed invention. Hence, should be disclosed.
EXTENT OF WIDESPREAD USE OF A TECHNIQUE IN A METHOD CLAIM IS MATERIAL TO PATENTABILITY
In the instant case, Ariosa challenged the Patent Trademark and Appeal Board’s decision that Verinata’s patent was not obvious, and thus still valid. Verinata and Ariosa are competitors in the relatively new field of prenatal diagnostics. Verinata is the patent owner. A few years back, tests to determine chromosomal abnormalities in unborn babies were conducted with high risk invasive testing procedures known as amniocentesis. A doctor pierces the amniotic sac to retrieve a sample of amniotic fluid and conduct tests. However, the discovery of fetal DNA circulating in the maternal blood suggested the possibility of safe non-invasive tests taken from the maternal blood which did not require any invasive entry into the amniotic sac. But, turning the discovery into a usable test presented significant challenges. One such challenge involved the low proportion of fetal DNA mixed in comparison with the maternal DNA. In order to overcome this challenge, the inventor (Verinata) used a multiplexing technique.
Ariosa in challenging the obviousness of Verinata’s patent presented a brochure from a different company to establish that multiplexing was in widespread use. The PTAB mentioned the Illumina brochure in its opinion but may have incorrectly limited consideration of the Illumina brochure. In particular, the Federal Circuit criticized the PTAB and indicated that the PTAB opinion could have been understood to say that it did not consider the Illumina brochure because it did not disclose anything specific about the claimed invention but was only directed to the background information regarding the widespread use of multiplexing. However, the Federal Circuit clarified that even background information must be considered since background information such as the prevalence of a particular technique can legitimately serve to document the knowledge that skilled artisans would bring to bear in determining obviousness.
The Ariosa case was in the context of a post grant proceeding challenging the validity of the Verinata patent. However, the Federal Circuit stated that background information is relevant to the patentability of the invention. Since background information is relevant to patentability, background information if known should be submitted in an information disclosure statement to satisfy one’s duty to disclose.
In practice, disclosing the extent of use of a particular feature, aspect or step or technique is difficult. How does one document or even though the widespread use of a particular feature, aspect, step or technique? Moreover, how does one know such information? Fortunately, the duty to disclose does not encompass or impose upon the inventor or those related to the prosecution of the patent application a duty to search or find or conduct any study to find such information. Accordingly, a general rule would be to disclose information that one has at hand, saved on one’s hard drive or otherwise documented in one’s files.