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Tafas v. Dudas; SmithKline Beecham Corp. v. Dudas – Permanent Injunction Granted.

Posted in Opinion Commentary, Practice Commentary by Jake Ward on April 1, 2008

Defendants Jon W. Dudas and the United States Patent and Trademark Office are permanently enjoined from implementing the Final Claims and Continuations Rules.

The opinion of Judge James C. Cacheris in the Eastern District of Virginia may be found here.  The order permanently enjoining the USPTO may be found here

GSK and Tafas brought suit against the USPTO to permanently enjoin the USPTO from enacting the USPTO’s final claims and continuations rules.  GSK and Tafas claimed that the rules were unlawful agency action under Section 706(2) of the APA and should be declared null and void.  The USPTO argued that the Final Rules were entirely lawful and that it should be permitted to go forward and implement the rules. More details on the background and specific rules changes may be found at our previous posts here, here, here, and here.  The Patent Docs have some exceptional background on the litigation, including copies of briefs filed, here.

In a well-written opinion, Judge James C. Cacheris rested his determination on the single dispositive issue of whether the USPTO is empowered to  establish the final claims and continuations rules under 35 U.S.C. § 2(b)(2), which allows the USPTO to “establish regulations, not inconsistent with law,” to “govern the conduct of proceedings in the Office.”

Judge Cacheris first noted that, even though the APA does not define a “substantive rule,” any rule that “affect[s] individual rights and obligations” has been deemed substantive by the courts.  With this understanding, Judge Cacheris found:

Though [the new contination rule) does not completely prohibit applicants from filing more than two continuation or continuation-in-part applications, because the USPTO intends to deny additional applications in almost all circumstances, . . . the “could not have been submitted” standard of the petition and showing requirement effectively imposes a hard limit on additional applications.  (Emphasis ours).


[T]he ESD requirement changes existing law and alters the rights of applicants under the current statutory scheme by shifting the examination burden away from the USPTO and onto applicants. . . .  [T]he Federal Circuit has stated that applicants have “no duty to conduct a prior art search” and “no duty to disclose art of which an applicant could have been aware. . .” .  In addition, Sections 102 and 103 provide that “[a] person shall be entitled to a patent unless” the claimed invention lacks novelty or is obvious in view of the prior art, 35 U.S.C. §§ 102 and 103, and Section 131 states that the USPTO “shall cause an examination to be made of the application”. . . . The Federal Circuit has read these provisions as placing the burden of examination and the burden of proof to make a prima facie case of unpatentability on the USPTO.


The 2+1 Rule and the 5/25 Rule, which limit continuing applications, RCEs, and claims, and the ESD requirement, which shifts the examination burden onto applicants, constitute a drastic departure from the terms of the Patent Act as they are presently understood. By so departing, the Final Rules effect changes in GSK’s and Tafas’s existing rights and obligations.

Accordingly, the Judge Cacheris held: 

Because the USPTO’s rulemaking authority under 35 U.S.C. § 2(b)(2) does not extend to substantive rules, and because the Final Rules are substantive in nature, the Court finds that the Final Rules are void as “otherwise not in accordance with law” and “in excess of statutory jurisdiction [and] authority.” 5 U.S.C. § 706(2).

Hat tip to the Patent Prospector.

USPTO-IP Australia Patent Prosecution Highway Pilot Program.

Posted in Practice Commentary by Jake Ward on April 1, 2008

The USPTO and the Australian Patent Office (IP Australia) have agreed to a trial program allowing applicants to fast-track patent applications.  Under the Patent Prosecution Highway (PPH) programs, an applicant receiving a ruling from either Patent Office that at least one claim in an application is patentable may request that the other Patent Office fast track the examination of corresponding claims in corresponding applications.  

Similar PPH programs are presently in place with the Japananese Patent Office (JPO), UK Intellectual Property Office (UKIPO), Canadian Patent Office (CIPO), and Korean Intellectual Property Office (KIPO). 

Per the press release from the Australian Patent Office:

IP Australia and the US Patent and Trademark Office (USPTO) today announced that they will launch a new trial cooperation initiative called the Patent Prosecution Highway (PPH) in April. For patent applicants with interests and applications in the US and Australia this program will result in faster patent examination times.

Under the PPH, an applicant receiving a report from either the USPTO or IP Australia with at least one patentable claim in an application may request that the other office accelerate the examination of the corresponding application. The applicant benefits from the patent offices using the work previously conducted by the other office, by obtaining corresponding patents faster and more efficiently.

“IP Australia is pleased to be taking part in the pilot program of the Patent Prosecution Highway with the USPTO,” said IP Australia’s Director General Philip Noonan. “We strongly support the aim of this initiative with its benefits of increasing quality and efficiency of examination while reducing pendency time. This service is a valuable addition to the patent examination services offered by IP Australia and provides Australian applicants with a process for fast-tracking the examination of their applications in a key market.”

“We welcome this opportunity to work cooperatively with IP Australia. This pilot represents a significant step in reaching worksharing on a global scale and extends the growing Patent Prosecution Highway network which will streamline the global patent system,” said Under Secretary of Commerce for Intellectual Property and Director of the USPTO Jon Dudas, “By leveraging each other office’s work , this pilot allows each patent office to attain efficiency gains and higher patent quality.”

Full requirements for participation in the trial program can be found at and

The trial program will allow the USPTO and IP Australia to determine the interest of patent applicants in such  program. It will also provide feedback on whether the aims of the program for an increase in quality and efficiency are met. The trial period is set for one year, but may be extended for up to one year.