As I noted last week, the USPTO is revisiting its guidance on the Duty of Disclosure in the wake of the Federal Circuit's en banc decision in Therasense. While the USPTO is reviewing the substantive requirements of the Duty of Disclosure, I hope that it also takes this opportunity to ease the procedural burdens associated with Information Disclosure Statements (IDSs).
Some IDS Burdens May Survive Therasense
Even though Therasense "tightened" the standards for inequitable conduct and announced a "but for" test for materiality, some of the administrative burdens associated with IDSs will survive, unless the USPTO also revises its procedural rules and requirements for IDSs. For example, if references of record in co-pending Application A might pass the "but for" test for materiality with reference to Application B, applicants still may be required to submit copies of documents already in the hands of the USPTO in Application A to make them of record in Application B, and to undertake the costly and time-consuming process of filing Requests for Continued Examination (RCEs) in order to comply with the current IDS rules.
Thus, my three proposed solutions to the "McKesson problem" remain necessary even if Therasense limits the reach of McKesson.
(1) Extend MPEP § 2001.06(b) to Co-Pending U.S. Applications
MPEP § 2001.06(b) provides that if an application is filed as a CON, DIV or CIP of an earlier application, the examiner will consider the prior art cited in the earlier application without the applicant having to cite to same art in the later application. The USPTO should extend this provision to co-pending U.S. applications that are identified by the applicant.
That is, once an applicant identifies a co-pending U.S. application (such as in an initial IDS), the examiner, not the applicant, would be obligated to periodically check the co-pending application file for new information that may be material to patentability. The examiner could do this, for example, prior to issuing each Office Action or a Notice of Allowance. This extra step could actually reduce examiner workload, because examiners could quickly assess whether any new information is relevant to patentability instead of having to review and process an IDS submitted by the applicant.
(I understand that this suggestion is not popular with examiners. Maybe it shouldn't be adopted, but I think there are good reasons to at least consider it or something similar.)
(2) Extend 37 CFR § 1.97 to Co-Pending Applications
The timing requirements of the current IDS rules include several exceptions for information first cited in a counterpart foreign application. The USPTO should extend these provisions to co-pending U.S. patent applications.
That is, applicants should be able to submit information newly cited in a co-pending U.S. application without having to pay a fee (after a first Office Action) or file an RCE (after a final Office Action). There is no reason the USPTO should make it more difficult for applicants to obtain consideration of information produced in a co-pending U.S. application as compared to a foreign application. Indeed, the USPTO is considering revising the Patent Term Adjustment (PTA) rules to eliminate the PTA penalties associated with IDSs filed to cite information newly cited in a co-pending application. It should eliminate the cost and pendency penalties as well, by revising 37 CFR § 1.97.
(3) Extend 37 CFR § 1.98 to Co-Pending U.S. Applications
The documentation requirements of the current IDS rules require applicants to submit copies of all references (other than U.S. patent documents) unless the references already were cited in an earlier U.S. parent application. The USPTO should extend this exception to co-pending U.S. applications. At the very least, the USPTO should extend the exemption that applies to U.S. patent documents to other published patent documents (such as published PCT and non-U.S. applications) that are easily available to examiners from WIPO or other websites.
Under current practice, if an Office Action is issued in a co-pending U.S. application that is not a parent application, an applicant may be required to file copies of the Office Action and cited references to comply with the IDS rules for the other application. In essence, an applicant may be required to copy and re-file at the USPTO the same documents that the USPTO just copied and mailed to the applicant.
While this burden may be alleviated somewhat once Office Actions and references can be filtered through a "but for" test, it is still possible that an applicant will want to submit documents cited in a co-pending application. This can be a particular problem in chemical and biotech applications, where the cited references may include PCT applications or applications with lengthy Sequence Listings.
An examiner can access information of record in the co-pending application electronically, and nearly as easily as information of record in the application at hand. Thus, there is no justification for imposing this burden on applicants. Indeed, this rule stems from the days of paper patent files, and now is obsolete in view of the USPTO's electronic file system.
The EPO is leading the way, by exempting applicants from having to submit Search Reports (i.e., Office Actions) from corresponding U.S. applications if the information is available on the USPTO's public PAIR website. If the EPO can obtain documents from U.S. patent application files, surely the USPTO can do the same!
The USPTO Should Act Now
As I've written previously, any one of these changes would go a long way towards addressing the burdens of the duty to disclose information produced in a co-pending U.S. application. Now that the USPTO is reviewing its Duty of Disclosure requirements in view of Therasense, it should take this opportunity to adopt these solutions and realize improved examination efficiency and immediate cost savings for both applicants and the USPTO itself.