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…
by SBCara on September 23, 2009
Merck Patent GmbH is the assignee of U.S. Patent No. 7,576,193, which issued August 18, 2009. The most notable aspect of this 29 page patent is the large number of publications cited on the face of the patent, or more accurately, on the first 9 pages of the patent. While I realize the volume of publications reported on the ‘193 patent is not a record by any means, seeing such a listing in print is a grim reminder of the potential repercussions for nondisclosure of a publication that might be deemed material five or ten years down the road. It’s a shame that holdings in cases such as McKesson Information Solutions, Inc. v. Bridge Medical, Inc., (Fed. Cir. 2007) compel an applicant and his attorney to submit any paper of which they are aware is associated with an application or application family, regardless of how remote the association to avoid a potential finding of patent invalidity and/or a potential charge of inequitable misconduct.
USPTO Director David Kappos delivered opening remarks at the IPO Annual meeting on Monday, September 14, 2009. For the full text version of the speech, see the USPTO website. In the speech, Director Kappos outlines a number of initiatives that he will be spearheading within the office. Included in the prioritized enterprises were incentivizing compact prosecution and cutting pendency across the board.
After pondering the importance of Director Kappos’ initiatives, I was perusing various patents that had issued yesterday, September 15, 2009. I noticed an application that was filed on January 7, 2003. Six years and nine months later—the patent issued. I was intrigued. While browsing the patent prosecution history, I came upon a response dated March 1, 2007, wherein the Applicants state, “The prosecution of the present claims has now reached six substantive office actions, including two since the Examiner withdrew a final office action as a result of a Pre-Appeal Brief conference. As the only pending rejections have now returned to references considered and withdrawn by the Examiner over two years ago, Applicants respectfully submit that it is now clear that no supportable rejection remains in the application. In view of the extended prosecution, Applicants respectfully request that a notice of allowance be expeditiously issued”. Following an additional Final Rejection, a Notice of Appeal, an Appeal Brief, an Examiner’s Answer to Appeal Brief, and the BPAI Decision wherein the Examiner was affirmed-in-part, spanning an additional two plus years, the patent issued. (U.S. 7,588,908 entitled, “Novel compositions and methods for inhibiting light-induced inactivation of biological reagents”). It is noteworthy that no RCE was filed in this case.
We wish Director Kappos all the best.