Posts Tagged ‘Therasense’

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Supplemental Examination Decision Tree – Lots of Dead Branches?

Tuesday, January 31st, 2012

Well, I wish it were that simple, but I keep trying to conjure examples that would lead me to use supplemental examination to “purge inequitable conduct (IC)” that I discover after my patent issues, and which could provide the basis for a successful IC attack on the patent. (Even the Office doesn’t presume that charges of inequitable conduct will go away post-Therasense.)

Issues of hard-core fraud on the patent office (e.g., faked experimental data in declarations and the like) aside, it would seem that I would first need to become aware of deceptive/evil intent involved with submission or failure to submit an item of information (IOI). If there is not some level of deceptive intent (knowingly withholding an IOI or making an incomplete submission), there will be no finding of IC by the court, even if the IOI (e.g., the publication) is “but for” material.

Now the deciding gets more difficult. If the IOI is “but for” material, you are going to have to narrow the claims. So I see no need to do other than file a narrowing reissue application. Remember, there is no longer a requirement to state that the overly broad claims were obtained “without deceptive intent.” Likewise, if the IOI is “but for” material and there is no evidence of deceptive intent, narrowing reissue is certainly the way to go. An example might be a 102(b) reference that was discovered years after the patent issued.

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PTO Proposes Supplemental Examination Rules – Extremely Expensive and Incredibly Complex

Thursday, January 26th, 2012

On January 25, 2012, the USPTO published proposed rules to implement the supplemental examination provisions of the America Invents Act (“AIA”). This procedure is intended to be utilized by patent owners to “clean up” patents of iffy validity before, say, asserting them in litigation or selling them. 77 Fed. Reg. 3666. This provision has been widely characterized as a way to purge inequitable conduct – or even an innocent failure to bring forth relevant information – that may have occurred during prosecution, by setting the record straight ex parte. If the petition for supplemental examination is accepted by the PTO as raising a substantial new question of patentability, the PTO will go on to order ex parte reexamination, which may, or may not result in the cancellation of claims. Alternatively, the PTO can refuse to order reexamination on the basis of the submitted information, and a certificate to that effect is attached to the patent. This sounds pretty straightforward but, or course, it is anything but.

To begin with, the fee for simply processing and treating a request for supplemental examination (“SA”) will be $5180. At the same time, the owner must pay a fee of $16,120 for an ex parte reexamination proceeding that may not occur. If reexamination is not ordered, the owner gets this fee refunded. There is no comment regarding any reduction for small or micro entities that I could find in my first read-through.

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Top 2011 IP Stories on Patents4Life

Saturday, December 31st, 2011

I spent a day or two looking back over the breaking IP news that resulted in posts on Patents4Life. I wrote most of them, but want to take a pause to thank regular contributors Paul Cole, Ron Schutz and Stefan Danner for their help. Patents4Life was originally intended to be a “blawg” focused on IP developments affecting the Life Sciences and, as 2011 comes to a close, I have put together a “top ten” list of stories to which attention had to be paid – by all of us in most cases – litigators, prosecutors and tech transfer professionals in the U.S. and abroad. The single most-apparent trend in IP last year was the increasing globalization of IP law – consider inter-office work-sharing and the prosecution highway. But I don’t want this column to go on into 2012, so here, in reverse order, are the “legal events” that dominated the netwaves in 2011. (I apologize for what I hope will be minor errors of fact and spelling – I am writing this from notes I made while back-tracking through the year.)

10. The Stem Cell Suits. In Sherley v. Sebelius, the district court finally dismissed the suit which had resulted in a ban on Federal funding for stem cell research, after the Court of appeals reversed its initial decision. (See Post, July 28th). However, in October, the Court of Justice of the EU ruled that claims to embryonic stem cells or even to cells that could become sources for embryonic stem cells were not patentable. (See post, Oct. 18th). Some types of gene therapy were indicated to be allowable. The future of embryonic stem cells is cloudy with a chance of further retreats like Geron’s.

9. On October 18th, Saint-Gobain petitioned for cert., urging the Supreme Court to answer a burden of proof question that comes down to: “Does holding a patent on an improvement on a patented invention that does not literally infringe insulate the accused infringer from infringement under the doctrine of equivalents?” This question has been simmering under the surface of infringement law for decades, the Fed. Cir. is clearly divided and the Supreme Court might bite. See Post of March 8, 2011 as well as October 14th post.

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BIO’s Modest Proposal – Eliminate Rule 56

Wednesday, December 7th, 2011

BIO recently sent Director Kappos 13 pages of comments on the PTO’s proposed revisions to 37 C.F.R. §1.56(b). (A copy of the comments is available at the end of this post.) BIO clearly is struggling to reconcile the differing views  of its members, and mostly succeeds. The comments give a good background on the development of the PTO’s duty of disclosure and the role of the judiciary in developing the inequitable conduct defense:

“Paradoxically, the development of the [IC] doctrine was driven, at least initially, by the well-intentioned belief that the judicial enforcement of applicant disclosure obligations in private actions to which the USPTO is not a party would nevertheless help the USPTO in getting its job done.”

This has obviously not occurred, and the comments note that in Therasense, the Fed. Cir. “declined to adopt the USPTO’s  definition of materiality as the judicial standard, recognizing that its prior efforts to enforce the USPTO’s materiality standards had actually contributed to the problems that led the court to take up this case in the first place.”

Despite this inherent tension, the comments go on to conclude:

“The USPTO proposes a literal importation of the judicial materiality standard into its Rule 56…There is good reason to believe, however, that the Therasense standard, in the course of judicial interpretation, will be subject to drift in the courts over time….thereby inviting creep and uncertainty in the operation of Rule 56….In short, most BIO members do not agree that administration of a judicial standard that is sure to evolve – and likely to erode – over time is the approach that will most benefit the USPTO and the applicant community.”

Responding to member input that there are few types of prior art that are not readily available to Examiners, and that the AIA pre- and post-issuance procedures will provide even more relevant information to Examiners, the comments get to the heart of the question and put a stake through it:

“The USPTO has not provided a clear explanation of why it continues to need Rule 56. If the  PTO wants only the Therasense standard ["hard" but-for materiality and specific intent to deceive], then there would seem to be no need for the rule – it is already the law. If the intention is to prevent fraud, lying, falsification, perjury and the like, federal statutes such as Section 1001  of Title 18 of the U.S. Code provide the applicable standard and the appropriate reach. The USPTO should affirm that it seeks nothing more.” 

Not just pretty words!

BIO Comments

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