Following up with Wednesday’s opinion in Therasense, Inc. v. Becton, Dickinson & Co. (Fed. Cir. 2011) (en banc), the U.S.P.T.O. released a press report Thursday indicating it was studying the decision and the effect the decision might have on the Office’s practices and procedures. According to David Kappos, Under Secretary of Commerce for Intellectual Property and Director of the U.S.P.T.O., the patent bar could expect to see guidelines from the Office for applicants regarding the materials they must submit under their duty of disclosure in light of Therasense.
With all the chatter about the court’s stricter “but-for-materiality” standard in the determination of inequitable conduct in Therasense, Inc. v. Becton, Dickinson & Co. (Fed. Cir. 2011) (en banc), I’ve yet to see/hear any analysis of the practical side. In reality, should the new decision promote a change the way we practice? Or does it just allow patent attorneys to sleep better at night knowing that in the event of litigation involving a patent we prosecuted, the likelihood of a determination of inequitable conduct is dimished? Don’t get me wrong, I’m thrilled about the decision. However, I don’t know that we can rely on this decision to discontinue notifying an examiner of related cases, cross citing Office Actions and ISRs, and obsessively submitting every publication to cross my desk remotely related to the subject matter of a particular case.
I’ll study the opinion for clues, but would be happy to hear from others who have some insight.
You’ve heard it before, whether from an insistent client, from a partner or senior associate for whom you were working on a project, or from a colleague in an ever fascinating discussion of the nuances of patent application drafting. “You have to tell the whole story.” “This may be the case that ends up in court and you want to lay out everything in the background to make it easier for the judge and jury to understand.” “This is the same introduction we used for our paper/abstract/poster – you can just throw it into the application background section to save time.”
And the procedure is seductive, especially for personalities of the sort that find themselves in patent prosecution practice and in particular in the biotech field. Many of us were scientists prior to our legal endeavor, having spent many hours writing papers or grant proposals and carefully laying out the problem that needed solving along with the logic we used to find the solution. Modesty was key. Group X made one finding, group Y made another finding, and we decided to try it here under different conditions and it worked. Or, two years ago we made a first determination and more recently made a second unrelated determination, logically leading us to make this conclusion.
Thus, for many of us, it’s entirely natural when drafting a new application to want to lay out the history of the invention from the beginning to the end. The wiser amongst us have counseled against this approach for many years. If we didn’t heed their warnings prior to the Supreme Court’s decision in KSR International Co. v. Teleflex Inc. (550 U.S. 398; 82 U.S.P.Q.2d 1385 (2007)), we should be so inclined from now on.
Under Part IIC of Justice Kennedy’s opinion when discussing the errors made by the Court of Appeals in its obviousness analysis, we find the following passage:
“One of the ways in which a patent’s subject matter can be proved obvious is by noting that there existed at the time of invention a known problem for which there was an obvious solution encompassed by the patent’s claims.” Emphasis added.
The client’s interests are best represented by a patent application that does not provide the Examiner with all the information he needs to issue an obviousness rejection of the claims.
A known problem. Sometimes, it’s just impossible to avoid defining the problem. It might be an old drug with a new use such as treatment of thyroid cancer. Well, people get thyroid cancer and that is the problem. A practitioner can do little to avoid this type of situation. However, sometimes identifying the problem is part of the invention. Perhaps identifying why conventional treatments are less effective or have certain side effects required innovation. When drafting an application we should emphasize why the identification of the problem required innovation and creativity, and certainly refrain from placing such information anywhere but the Description section of the specification. Alternatively, this information can be saved for a later date, when, during prosecution, a § 1.132 Declaration might be helpful. Regardless of when and how you use information defining “the problem”, there is no obligation to make the Examiner’s job easy by providing him with cheap ammunition for a rejection.
An obvious solution. Justice Kennedy goes on to write later, still under part IIC, “that familiar items may have obvious uses beyond their primary purposes, and in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle”. As the one preparing the patent application, we might know all the pieces of the puzzle. That doesn’t mean that those pieces fit together in any obvious way at the time the invention was made or that it would have been obvious to even attempt to put the pieces together. However, looking back there may be a reasonable explanation as to why it worked – we have no obligation to provide this explanation, particularly in the Background of the specification. Again, this information might be useful in a § 1.132 Declaration, or possibly in the Description but couched as theory. Let the Examiner develop his own reasoning as to why the solution might be obvious rather than using our own words to make his arguments.
In our last post, Materiality and a Legitimate Paranoia, we argued that egregious holdings in cases can compel an applicant and his attorney to submit a gargantuan amount of art in order to avoid a charge of inequitable misconduct. The McKesson decision was particularly effective in inducing Applicants everywhere to cite enormous numbers of Office Actions on their 1449s. Although this type of disclosure effectuates the problem, perhaps it is the field in which we practice, regardless of case interpretation, which ultimately leads to this excess disclosure in the first place. I was browsing through biotech patents that issued on 9/29/2009. Overwhelmingly these patents contained pages upon pages of cited references—considerable even after excluding cited Office Actions. I am guessing that the excess disclosure has something to do with the fact that these were biotech patents. Research in the area of biotechnology produces an enormous pool of publications, containing slight variations and nuances over previously published work. As such, the determination of materiality becomes more of an art than a science. With the penalty of inequitable misconduct ever-present, Applicants tend to cite generously.
37 CFR § 1.56 reads, “A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section.”
However, the excess citation of references does not yield the most effective patent examination. Citing over 100 plus references does not help an Examiner to narrow in on the most closely related art. On the other hand, from an Attorney’s point of view, given the dire consequences of inequitable misconduct, an Applicant is loathe to take the risk of under citation. Perhaps patent offices such as those in Europe and Australia are on to something…