Patent Owner Requesting Reexamination may not Appeal to the Board the Examiner’s Grant of Reexamination
Scott Daniels | February 23, 2011
The PTO Board’s second decision yesterday in Ex Parte Yasukochi – involving a patentee-requested reexamination of U.S. Patent No. 7,034,083 for an adhesive for a transdermal patch – instructs practitioners on how to challenge an examiner’s decision that a substantial new question of patentability (SNQ) is presented.
Last June, the Board issued its first decision in the Ex parte Yasukochi, concluding, inter alia, that may a patentee may challenge an examiner’s determination that a substantial new question of patentability has been presented, and the consequent grant of reexamination, by petition to the Commissioner, but not by appeal to the Board. Shortly after the first Yasukochi decision, the PTO Director issued a notice (75 Fed. Reg. 36,357 (June 25, 2010)) delegating authority to the Chief Administrative Law Judge “to review issues related to the examiner’s determination that a reference raises [an] SNQ.” The Board subsequently withdrew its first Yasukochi decision and ordered new briefing on whether the Director’s Order affected that decision.
The Board’s second Yasukochi decision yesterday reached essentially the same conclusion as its first: the Director’s notice provides for a challenge to an examiner’s determination of an SNQ. Here, the patentee challenges a particular rejection, not the original determination of an SNQ. The Board explained that “the Notice does not delegate authority to the Board to decide whether a particular initiated reexamination is outside the scope permitted in an ex parte reexamination.” It is only the threshold determination of an SNQ that the Director’s Notice permits to be appealed to the Board.
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DexCom Wins Major Reexamination Victories over Abbott
Scott Daniels | January 31, 2011
DexCom’s strategy for dealing with its litigation against Abbott Diabetes Care Inc. through reexamination has taken a major step forward – in separate opinions (here & here) the PTO Board of Appeals affirmed the final rejection of two Abbott patents, U.S. Patent Nos. 6,175,752 and 6,565,509 claiming an assembly for attachment to the skin of a patient and for sensing and reporting levels of specific substances in the patient, such as glucose levels.
In 2005, Abbott sued DexCom for infringing the ‘752 and ‘509 patents and two other patents, U.S. Patent Nos. 6,284,478 and 6,329,161, claiming subcutaneous glucose electrodes. Abbott subsequently sued DexCom for infringing three additional patents, U.S. Patent Nos. 5,899,855, 6,134,461 and 6,990,366 for related microprocessor video and electrochemical analyte monitoring equipment. DexCom replied by filing reexamination requests against each of Abbott’s seven patents, and each request was granted. The trial judge merged the two infringement cases and then stayed the litigation pending completion of all the reexaminations.
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Two Items of Interest
Scott Daniels | January 5, 2011
1. Smucker Case at the Board
Subscribers may be interested in our report on the surprising outcome at the Board in the Smucker case, which was posted on IPWatchdog this Monday.
2. New Comments on Reexamination Stays
Judge Neil V. Wake made some interesting observations on the factors of “simplification of issues” and “prejudice to the patentee” in his recent decision to stay in Caron v. QuicKutz, Inc., 2010 U.S. Dist. LEXIS 137786.
He had initially denied a motion by the accused infringer to stay the case pending completion of the reexamination of the patent-in-suit, in part, because the PTO proceeding had just begun. Since then, however, the PTO has issued a non-final rejection of all the claims. Judge Wake stated that “the Court presumes that an all-inclusive non-final rejection suggests that the PTO will finally reject at least some claims. Such [a] rejection would simplify the issues in this litigation.”
Regarding the “prejudice” factor, Judge Wake took a little poke at the PTO, commenting that “the PTO’s pledge to reexamine the Caron patent with ‘special dispatch’ is boilerplate drawn from a statutory requirement,” but he then found that “it appears that the PTO has moved more quickly than usual on this reexamination,” undermining “Plaintiffs’ previous estimates of the damage that may accrue during a stay period….” The Judge also ordered the parties to report the actual progress of the reexamination.
Secondary Considerations a Tough Sell in Reexamination
Scott Daniels | December 13, 2010
Traversing an obviousness rejection by arguing “secondary considerations” – such as the commercial success of the claimed invention – has always been difficult for patentees in reexamination, especially with the requirement of a nexus between the secondary considerations and the claimed invention. Just how difficult that argument can be was demonstrated today in the PTO Board’s analysis of the reexamination examiner’s obviousness rejection in Ex parte Smiths Interconnect Components, Inc.
The claimed invention was a “temperature variable microwave attenuator,” featuring resistors with different temperature coefficients. The examiner rejected the claims as being obvious over a series of prior art combinations. The patentee challenged the rejection with a variety of arguments, most notably an assertion that the claimed invention was nonobvious because it had enjoyed a remarkable commercial success: two declarations showed that 10,000,000 of the claimed attenuators had been sold since 1994 at strong profit margins; that the patentee once possessed 100% of the world market for commercial surface mountable temperature variable attenuators; that the patentee still retains substantial portions of that market; and that only the patentee’s attenuators have been certified for US and NATO military and space applications.
The patentee coupled these facts with citations to Federal Circuit precedent in which proof of commercial success of an embodiment of the claimed invention was held to constitute a prima facie case of nexus between success in the market and the claimed invention.
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Alza Overcomes Obviousness Rejection at Board for its Patented Method for Treating Depression
Scott Daniels | December 8, 2010
Earlier today, the PTO Board reversed the examiner’s obviousness rejection of the sole claim of Alza’s U.S. Patent No. 6,440,457. The reversal demonstrates the skillful use of declaration evidence to overcome a prima facie case of obviousness.
The ‘457 patent claims a method of orally administering the anti-depressant drug venlafaxine (Effexor®) in the form of “a sustained-release dosage” or “a controlled-release dosage.” Administration occurs “over an extended period of time in a therapeutically responsive dose to produce [an] antidepressant therapy.”
The reexamination examiner rejected the claim as being obvious over a combination of references. First, he relied on certain primary references for the disclosure venlafaxine for use in treating depression. The examiner acknowledged that these references failed to disclose administration of the drug in “a sustained-release dosage form” or “a controlled-release dosage form.” To fill this gap, the examiner cited certain secondary references that disclosed the advantage of controlled drug release and showed that those skilled in the art were familiar with the specifics of controlled and sustained release delivery systems. The examiner concluded that the references would make the ‘457 claimed invention obvious.
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Examiner Applies Recapture Rule too Broadly
Scott Daniels | November 9, 2010
The PTO Board ruled last week that the examiner in Ex parte James had misapplied the Recapture Rule when he rejected amended reissue claims under 35 U.S.C. § 251 for improper recapture.
The Recapture Rule prohibits a patentee from recapturing through a reissue application subject matter that it had surrendered by amendment or by argument during the prosecution of the original application to overcome prior art. It is based on the right of the public to rely upon such amendments or arguments as a permanent surrender of that subject matter. The question of whether “surrender” has occurred is considered from the perspective of “an ordinary observer viewing the prosecution history.”
The patent for which reissue was sought claimed a method for cutting and sealing two layers. During the original prosecution, applicants distinguished their claimed method from the prior art because of the location of a heater in an air space between V-belts.
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Precision BioSciences Wins Victory over Cellectis
Scott Daniels | November 1, 2010
The PTO has issued a Right of Appeal Notice (RAN) in the inter partes reexamination of Cellectis’ U.S. Patent No. 7,309,605 entitled “Nucleotide Sequence Encoding the Enzyme I-SceI and the Uses Thereof.” The ‘605 patent now joins three other related Celectis patents – U.S. Patent Nos. 6,610,545, 6,833,252 and 7,214,536 – that have been rejected in reexamination and are now on appeal before the PTO Board. The reexamination proceedings were requested by Precision BioSciences.
Cellectis had filed a Complaint against Precision in the Eastern District of North Carolina in March 2008 for infringement of the ‘605 and ‘545 patents. Precision’s accused product is called a “Directed Nuclease Editor” (DNE). According to Cellectis, Precision’s DNE makes Group I intron coded endonucleases used to target site-specific DNA breaks and modify the genome of plants. The ‘605 and ‘545 patents are owned by Institut Pasteur and Universitie Pierre et Marie Currie; Cellectis is the exclusive licensee.
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Examiner Misapplies Statutory Prohibition against Enlarging Claim Scope in Reexamination
Scott Daniels | October 28, 2010
Qualcomm won an important victory yesterday when the PTO Board of Appeals reversed the reexamination examiner’s rejection of most of the claims of U.S. Patent No. 5,778,338 – see Ex parte Qualcomm. The ‘338 patent claims an apparatus and method for compressing speech for transmission. Qualcomm sued both Nokia and Broadcom for infringement of the ‘338 patent and later settled.
What interests us in the case, however, is the Board’s treatment of the examiner’s rejection of claims 9 and 10 for enlarging the scope of the claims, in violation of 35 U.S.C. § 305.
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Requester Appeals PTO’s Refusal to Adopt Rejections, and Wins (Corrected Version)
Scott Daniels | October 22, 2010
Much is made of the fact that the PTO grants the overwhelming majority of requests for reexamination and then adopts at least some of the rejections proposed in the request. So what do you do if the PTO does not adopt your rejections? In May 2009 NuVasive requested inter partes reexamination of Warsaw Orthopedic’s U.S. Patent No. 6,969,390 for a medical appliance, proposing ten distinct prior art rejections. When the examiner granted the request, but refused to adopt the proposed rejections, NuVasive appealed. Yesterday the Board reversed the refusal and remanded the case to the examiner, with instructions to adopt NuVasive’s first proposed rejection of claim 1 and to reconsider four other proposed rejections of certain dependent claims.
The ‘390 patent claims a “plating system” for application to the human spine, including a cervical plate and a bone screw. The primary reference relied upon by NuVasive discloses each of the claim limitations, except for certain structural features of the screw. A secondary reference, however, discloses a plating system with a screw having those structural features. In denying the request for reexamination, the examiner concluded that there would be no reason for one skilled in the art to replace the screw of the primary reference with the screw of the secondary reference.
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PTO Board Reverses Rejection of Artemis Medical Claims
Scott Daniels | October 18, 2010
The PTO’s Central Reexamination Unit (CRU) has been criticized recently for construing claims too broadly, according to the “broadest reasonable construction” standard. Justice was done, however, in the Board’s decision Friday, Ex parte Artemis Medical, reversing the examiner’s rejection of the claims of U.S. Patent No. 6,730,042.
The ‘042 patent claimed a “target tissue localization device” for marking a biopsy cavity. The claims included the limitation of a bioresorbable body “comprising polylactic acid and polyglycolic acid.”
The examiner construed the claim as covering not only embodiments in which the bioresorbable body has both polylactic acid and polyglycolic acid, but also embodiments in which bioresorbable body has only polylactic acid and embodiments in which it has only polyglycolic acid. The examiner justified this broad construction on correspondingly broad disclosure in the ‘042 specification that the bioresorbable body could be “one or more” members of a list of materials. The examiner then rejected the claims as being obvious over a prior art reference, as well as being obvious over a combination of prior art references.
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