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Tag Archives: Therasense

Public Comments Criticize USPTO’s Proposed Rules For “Routine Discovery,” “Patentee Estoppel,” and Amendments in Board Trial Proceedings

Posted in Duty of Disclosure; Patent Reform; USPTO Proposed Rule Changes

As I previously pointed out, there are three proposed rules in the USPTO’s patent trial proceedings rules package that raise concerns and should be dropped.  Public comments on these proposed rules were due April 9-10, 2012.  Now that the public has spoken, let’s take a look at what people had to say about these three specific proposals.Continue reading this entry

USPTO Adapts To Therasense

Posted in USPTO Proposed Rule Changes

The USPTO announced on July 21, 2011, that it plans to “revise the standard for materiality” for the duty of disclosure in view of the Federal Circuit’s decision in Therasense, Inc. v. Becton, Dickinson & Co. In particular, the USPTO plans to “match” the materiality standard the court announced in the context of its inequitable conduct decision. The USPTO acknowledges that the Supreme Court may take up Therasense for review, but has decided to move forward for the time being. The USPTO will accept written comments on its proposal until September 19, 2011.

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Revisiting IDS Guidlines? While You’re At It . . .

Posted in Patent Office Practice

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).

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USPTO Will Issue Guidance On Therasense

Posted in Inequitable Conduct; Patent Office Practice

On the heels of the Federal Circuit’s en banc decision in Therasense, the USPTO has announced that it will be issuing guidance “related to the prior art and information [applicants] must disclose to the Office in view of Therasense.”

According to the USPTO’s press release:

We are now studying the potential impact of Therasense . . . on Office practice, and we expect to soon issue guidance to applicants regarding the materials they must submit to the Office under their duty of disclosure.

As I noted in my case summary, the Therasense decision expressly rejected the “materiality” standard set forth in USPTO Rule 56 (37 CFR § 1.56). Thus, the USPTO may revoke or revise this rule, although new provisions might be promulgated through the notice and comment process.  Several provisions of MPEP Chapter 2000 are based on Rule 56, and may be revised as well.

It will be interesting to see whether the USPTO conforms its rules and guidance to the court’s decision, or tries to maintain a higher duty of disclosure.

Therasense Decision “Tightens” Inequitable Conduct Standard

Posted in Federal Circuit Decisions; Inequitable Conduct

On May 25, 2011, the Federal Circuit issued its long-awaited en banc decision in Therasense, Inc. v. Becton, Dickinson & Co. After a panel affirmed the district court’s finding of inequitable conduct, the court agreed to rehear the appeal en banc in order to revisit the law of inequitable conduct. The court’s decision “tightens the standards” for proving inequitable conduct, holding that evidence of “intent” must be considered independently from materiality, and that materiality generally must be proven by a “but-for” test, except in cases of “affirmative egregious misconduct.”

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Will The Federal Circuit’s Therasense Decision Solve The McKesson Problem?

Posted in Duty of Disclosure; Federal Circuit Decisions; Inequitable Conduct

This week the Federal Circuit heard oral arguments in its en banc rehearing of Therasense, Inc. v. Becton, Dickinson & Co. As reflected in the en banc order, the court took this case en banc in order to reconsider—and hopefully reform—the law of inequitable conduct. The court’s decision could solve the McKesson problem and rein in the threat of inequitable conduct charges that drives practitioners to submit references even when they are not believed to be relevant to patentability. 
 

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Time to Run Background Checks?

Posted in Federal Circuit Decisions; Inequitable Conduct

Two recent decisions from the Federal Circuit warn that misstatements in the background section of a patent application can constitute "misrepresentations of material fact" that can support a finding of inequitable conduct. These cases may have practitioners reviewing the background sections of pending applications and reconsidering the type of information included in the background sections of future applications.

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