PTO Proposes to Eliminate BRI at PTAB

The USPTO recently announced proposed rulemaking that would change the prior policy of using the Broadest Reasonable Interpretation (“BRI”) standard for construing unexpired and proposed amended patent claims in PTAB proceedings under the America Invents Act and instead would use the Phillips claim construction standard. The new standard proposed by the USPTO is the same as the standard applied in Article III federal courts and International Trade Commission (“ITC”) proceedings, a change critics of the PTAB process have urged for many years in order to bring uniformity to post grant challenges across forums.

“Having AIA trial proceedings use the same claim construction standard that is applied in federal district courts and ITC proceedings also addresses the concern that potential unfairness could result from using an arguably broader standard in AIA trial proceedings,” the NPRM says. “Under the proposed approach, the Office would construe patent claims and proposed claims based on the record of the IPR, PGR, or CBM proceeding, taking into account the claim language itself, specification, and prosecution history pertaining to the patent. The Office would apply the principles that the Federal Circuit articulated in Phillips and its progeny.”

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PTAB Fails to Consider Arguments in Reply Brief

On Friday, June 1st, the Court of Appeals for the Federal Circuit issued a decision in In re: Durance striking down a decision by the Patent Trial and Appeal Board (PTAB) that affirmed a patent examiner’s obviousness rejection of a microwave vacuum-drying apparatus and associated method. The Federal Circuit panel consisting of Judges Alan Lourie, Jimmie Reyna and Raymond Chen determined that the PTAB erred in not considering arguments offered in the patent applicant’s reply brief, which were properly made in response to the examiner’s answer.

In September 2014, the examiner issued a final rejection, which rejected all 37 claims of the patent application on 35 U.S.C. § 103 for obviousness and 35 U.S.C. § 112 for not meeting the written description requirement and lack of enablement. The obviousness finding was based on two pieces of prior art: U.S. Patent No. 6442866, titled Method and Apparatus for Drying or Heat-Treating Products (“Wefers”) and issued in September 2002; and U.S. Patent Application No. 20050019209, titled Method and Device for Sterilizing Containers (“Burger”) and filed in July 2002. The examiner rejected most of the ‘895 patent applications claims after finding that Wefers disclosed every limitation of claim 1 except for the tumbling limitation, which was itself disclosed by Burger. The examiner rejected Durance’s argument that rotating the container to enhance tumbling of the organic material was not present in the Wefers and Burger combination; the examiner found that the organic material’s tumbling was an inherent function of all rotating containers. On the indefiniteness finding, the examiner found that the patent application’s specification did not meet the written description requirement under Section 112 because it did not discuss the rotational speed necessary to tumble the organic material.

After an examiner interview in December 2014, the examiner withdrew the rejection based on the Section 112 grounds but maintained the obviousness rejection based on Burger’s teaching of a transportation means rotating a container through a vacuum chamber from the inlet to the outlet. Durance appealed to the PTAB, arguing that Burger taught the application of plasma to the surface of containers and not the rotation of the containers to tumble the contents for balancing out the microwave radiation applied to the cylinders. Durance further argued that Wefers taught away from agitating products during transportation because it stressed the “gentle continual transport” needed to reduce maintenance expenses. The examiner answered this argument based on new grounds that there was no structural difference between Durance’s claimed invention and the combination of the prior art references. Although Durance argued that the examiner’s understanding of structural identity for rejection, which had never before been articulated, was extremely inaccurate as the claimed invention in the ‘895 patent application required the use of gears, not simply gravity. The PTAB sided with the examiner, finding that Durance’s arguments only addressed individual references and not the combination.

Durance appealed for rehearing by the PTAB, arguing that the Board erroneously ignored reply brief arguments related to the structural identity rejection. In not addressing arguments that the claimed structure is different than the Burger structure, the PTAB “misapprehend[ed] the law” on inherency by ignoring the argument that structural identity cannot be used to show that a method claim is inherently performed by a combination of prior art references. In denying the request for rehearing, the PTAB stated that it did not misapprehend the doctrine on inherency because it didn’t invoke that doctrine in affirming the examiner’s rejection. “In the interest of fairness,” the Board did consider Durance’s reply brief argument that the amount of material packed into the container affects whether the material would tumble, but the Board reiterated that it would not consider other reply brief arguments.

On appeal to the Federal Circuit, Durance argued that substantial evidence doesn’t support the PTAB’s finding that the combination of the prior art references taught the tumbling limitation either expressly or inherently. Durance also argued that the PTAB lacked substantial evidentiary support to show that a skilled artisan would modify Wefers to include the rotation feature disclosed by Burger.

In its discussion of the issues in the appeal, the Federal Circuit opined that “the Court is not confident in the Patent Office’s reasoning for its rejection of the Application” based upon the shifting arguments offered in the patent examiner’s rejections, as well as the PTAB’s argument on appeal that the Federal Circuit should find inherency in the first instance after the PTAB told Durance that inherency was never invoked. In analyzing 37 C.F.R. § 41.41(b), the relevant statute under which the PTAB waived Durance’s reply brief arguments, the Federal Circuit noted that the statute allows a patent owner to include responses to an examiner’s answer in a reply brief. Nothing in the statute bars the patent owner from addressing new arguments made by the examiner that were not articulated in the Final Office Action, the appellate court found.

The PTAB’s refusal to consider Durance’s reply brief arguments on structural dissimilarity between the patent application and the prior art references required vacating the agency’s decision and remanding the case back to the Board, the Federal Circuit held.

Predictions and Musings on 2018

Each year, I ask a panel of industry experts to make predictions for the upcoming year, and to identify particular news, stories or events they will be watching with interest. See Predictions for 2018 and Topics to Watch in 2018.

Given that several industry insiders were willing to make their own predictions, it seems only fair for me to likewise go out on a limb and make my own predictions.

First, I predict that the United States Supreme Court will find post grant procedures under the America Invents Act to be unconstitutional. It is my belief they took Oil States not as a patent case, but rather as an Administrative State case, and if that is correct, this could be the first in a series of decisions over a number of years that will pull authority back from the growing Administrative State and toward the Judiciary.

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PTAB denies claims of 11th Amendment sovereign immunity

Several weeks ago, the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) denied a motion filed by the University of Minnesota in a series of inter partes review (IPR) cases. See Order Denying Patent Owner’s Motion to Dismiss. This extraordinary denial of the motion is newsworthy because Minnesota sought a dismissal of the IPRs based on Eleventh Amendment sovereign immunity. The PTAB previously dismissed similar IPRs against state-owned patents. Here, however, the PTAB in a majority opinion authored by Chief Judge David Ruschke (pictured left), disagreed and refused to dismiss the IPRs.

The PTAB ruled that the University of Minnesota “waived its Eleventh Amendment immunity by filing an action in federal court alleging infringement of the patent being challenged in this proceeding.”

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Eli Lilly cancer treatment upheld by PTAB

Several weeks ago, a final written decision issued by the Patent Trial and Appeal Board (PTAB) upheld a series of 22 claims from a patent owned by Indianapolis-based drugmaker Eli Lilly & Company. This decision ends an inter partes review (IPR), which was initially petitioned by Chicago-based generic pharmaceutical firm Neptune Generics to challenge a patent covering Alimta, a drug approved by the U.S. Food and Drug Administration (FDA) as a treatment for patients with advanced nonsquamous non-small cell lung cancer (NSCLC).

The Eli Lilly patent challenged by Neptune in the IPR was U.S. Patent No. 7772209, titled Antifolate Combination Therapies. Issued in August 2010, it covers a method for administering pemetrexed disodium to a patient in need thereof by administering effective amounts of folic acid and a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium; the particular methylmalonic acid lowering agent used by the treatment is vitamin B12. The use of vitamin B12 in the treatment helps to reduce the cytotoxic activity which antifolates can create in a patient’s body when that patient is undergoing chemotherapy, helping to limit the potentially life-threatening toxicity which antifolates can cause in the human body.

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