The Duty of Disclosure Imposed by the US Patent Laws on Patenting Persons
What is the Duty of Disclosure?
The US Patent Laws impose a duty of disclosure (the “Duty of Disclosure” or “Duty”) requiring all persons associated with a non-provisional patent application pending before the United States Patent and Trademark Office (the “USPTO”) to bring to the Examiner's attention any known prior art reference that the Examiner may consider “material” to the patentability of any claim(s) of the pending application.
By “all persons,” they mean each inventor, the Applicant, its representative, and any agents thereof must satisfy the Duty. Any doubts about whether or not to disclose a particular piece of information should always be resolved in favor of disclosure.
Additional Details Regarding the Duty of Disclosure
The Duty requires disclosure of any known reference that the Examiner may consider “material” to the patentability of any pending patent claim(s). Generally speaking, information is considered material if a reasonable examiner would have considered the information to be important when determining patentability of one or more pending claims. For example, any information that:
counts as prior art under 35 USC § 102 and associated case law; and
may support an allegation of unpatentability against a pending claim, either by itself or in combination with other information, such as anticipation under § 102 associated case law and/or an allegation of obviousness under 35 USC § 103 associated case law,
would be considered material to the patentability of the claim. Any information that refutes or is inconsistent with arguments made by an Applicant or the representative during prosecution of a pending patent application would also be considered material to patentability.
The Duty of Disclosure is enabled by statute in 37 CFR § 1.56. Other aspects of the Duty are defined in the USPTO’s Manual of Patent Examining Procedures at MPEP § 2001 – Duty of Disclosure, Candor, and Good Faith. Still other aspects of the Duty and its limitations are defined by case law with respect to the doctrine of inequitable conduct, such as in:
Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1290 (Fed. Cir. 2011) (en banc) (stating that an accused infringer may escape liability for patent infringement by providing clear and convincing evidence that the patentee: (a) knew of the reference or prior commercial sale, (b) knew that it was material, and (c) made a deliberate decision to withhold it).
GS Cleantech Corp. v. Adkins Energy LLC, 951 F.3d 1310 (Fed. Cir. 2020) (ruling that CleanTech’s Patents-in-Suit are unenforceable due to inequitable conduct by the inventors and CleanTech’s attorneys).
Belcher Pharmaceuticals LLC v. Hospira Inc., 11 F.4th 1345 (Fed. Cir. 2020) (finding the district court did not err in concluding chief science officer engaged in inequitable conduct by withholding material information from PTO during prosecution of patent at issue with deceptive intent particularly given his central role in both FDA approval and patent prosecution of product already on market).
Regeneron Pharms., Inc. v. Merus N.V., 864 F.3d 1343 (Fed. Cir. 2017) (affirming that a patent is unenforceable because of appellant's inequitable conduct during prosecution, drawing an adverse inference as to specific intent to deceive the PTO).
Ohio Willow Wood Co. v. Alps South, LLC, 813 F.3d 1350 (Fed. Cir. 2016) (holding that the district court did not abuse its discretion in finding the defendant committed inequitable conduct during a reexamination proceeding by withholding key documents to corroboration of inventorship and making affirmative misrepresentations about a key participant's supposed admission somewhere in the record).
McKesson Info. Solutions, Inc. v. Bridge Med., Inc., 487 F.3d 897 (Fed. Cir. 2007) (holding that the district court did not clearly err in finding that plaintiff intended to deceive the PTO by not disclosing the examiner's allowance of patent claims for a three-node communication system and rejection of a co-pending application concerning the three-node communication and unique bar code address, especially where plaintiff made statements to the examiner that nothing in the prior art disclosed three-node communication).
As the above-cited statutes and case law confirm, a reviewing court may accept any public information and some private information (e.g., sales) as prior art. Some representative examples of typical information that may be material include:
relevant publications of the inventors prior to the filing date of the application;
any patent or non-patent publications uncovered in a search by the inventor or any other interested party, especially searches made specifically for patentability determinations;
copies of websites, other U.S. applications (whenever filed) and earlier foreign applications relating to similar subject matter;
other U.S. patents by the inventor(s) and references cited in those patents,
search reports from corresponding foreign applications;
inventorship disputes and public use or sale or offer for sale of the invention in the United States prior to the filing date of the application;
any products that exist and/or are currently available for sale; and
any other information that is generally available to the public.
It is an open question whether arguments made to non-US patent offices with respect to issues of foreign patent laws count as material information given the often broad differences between the US patent laws and those of other countries. As with most questions regarding the Duty, it is best to disclose the arguments if they relate to the patentability of a pending US patent claim.
How and When to Satisfy the Duty of Disclosure
The Duty of disclosure may be satisfied by filing an Information Disclosure Statement (or “IDS”) with the USPTO, which is typically done via Form PTO/SB/08a. An IDS may be filed at any time during the prosecution of pending application. The government fees associated with filing an IDS are dependent upon when it is filed so as to incentivize early disclosure. For example, each IDS may be submitted:
without payment of any government fees if submitted:
within three months of the filing date,
before a first official action is issued, or
between the time a first official action is issued and the issuance of a final rejection or notice of allowability up to three months after the discovery of the information; or
with payment of government fees if submitted:
after knowing about the information for more than three months,
after a notice of allowance or final rejection, or
at any time prior to paying the issue fee.
You should disclose any material information as soon as it comes to your attention, preferably before or shortly after filing your application. If it becomes necessary to file an IDS after receiving a notice of allowance, then you should be ready to take immediate action.
Consequences of Failing to Satisfy the Duty
Failing to satisfy the Duty of Disclosure may result in a finding of inequitable conduct. Generally speaking, a finding of inequitable-conduct renders all claims within the patent family unenforceable, not just the specific claim for which the invalidating information was withheld.
Further, anyone associated with the inequitable conduct, especially the patent owner, can be liable for attorney fees of the accused infringer. If the patents obtained inequitably are used to secure a monopoly, the patent owner also may face antitrust violations.
Patent attorney and agents who have been found to engage in inequitable conduct can face disciplinary proceedings by the USPTO, and can ultimately lose their license.
Conclusion
Any doubts about whether or not to disclosure a particular piece of information should always be resolved in favor of disclosure. This is not an area to take risks. Please contact us to discuss the particulars if you have any questions about the Duty of Disclosure.
Fulfilling the Duty can be a straightforward process so long as open lines of communication between assignee, inventors, and their patent attorneys are maintained. Communicating all prior art to your patent attorney allows for stronger claim drafting and timely disclosure of known prior art references, eliminating unnecessary fees. The Duty may be unique to US practice but is not hard to satisfy if everyone works to identify and disclosure what they know in a timely manner.
Our team utilizes software for populating IDSs and tracking which references have been cited in which applications, making it easy and efficient for us to satisfy our respective Duties. In complement, we are trained to take note of and be certain to cite any relevant information that emerges during our conversations and/or pursuant to any patent searches you instruct us to complete. Because of these efficiencies, we are able to charge a fixed-fee for IDS services.
Limitations of Patent Counsel
Your patent counsel cannot possibly cite any references that are known to you or your team and yet not disclosed to counsel. For that reason, you must continuously take your own inventory as to what has been cited in your pending applications and be diligent about making sure the Duty of Disclosure is satisfied for all parties.
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Thank You for Reading!
Matthew Leaper & Associates can help you resolve these and related issues in a professional, efficient manner. Mr. Leaper and his team know how to effectively communicate with the USPTO, have extensive knowledge of its requirements and timeframes, and are well versed in all phases of the patent process, making us well suited to help realize your ambitions.
