PharmaPatents : Helping You Maximize Your IP in the Chemical, Biotech, and Pharmaceutical Fields

In "Ten Tips for Streamlining Patent Prosecution," Director Kappos outlines ten steps that he would like practitioners to take in order to promote compact prosecution. While I agree with most of these steps in principle, often the realities of patent prosecution, business decisions and innovation itself get in the way. Here I discuss items 6-9 of his list.

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One interesting feature on the USPTO's Patent Application Information Retrieval (PAIR) website is the "First Action Prediction" tool. Once you enter an application number, you can click on the "First Action Prediction" tab, and it will give you an estimate of the time to the first Office Action. There also is an option to generate a dated "letter" that will print out on USPTO letterhead. Typical text of the letter is reproduced below:

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Shortly after the Supreme Court issued its decision, the USPTO published "Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos." The guidance is to be used by examiners when evaluating process claims for patent-eligibility under 35 USC § 101. The Interim Guidance was effective as of its July 27, 2010 publication date, but the USPTO is accepting written public comments until September 27, 2010. 

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I'd like to respond to Director Kappos' blog posts on "Five Tips for Practitioners" and "Ten Tips for Streamlining Patent Prosecution." First, I want to emphasize that I believe that patent prosecution should be a cooperative process, with practitioners and examiners sharing the same goal of issuing the broadest valid patent to which the applicant is entitled. I also want to acknowledge that applicants sometimes pursue strategies that complicate and prolong prosecution. Still, I believe that there are at least a few things that examiners can do to promote compact prosecution. 

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Two recent decisions from the Federal Circuit warn that misstatements in the background section of a patent application can constitute "misrepresentations of material fact" that can support a finding of inequitable conduct. These cases may have practitioners reviewing the background sections of pending applications and reconsidering the type of information included in the background sections of future applications.

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In a case that did not present the issue, Judge Dyk wrote a separate opinion to express his views that a claim directed to “[a]n isolated DNA molecule” “raises substantial issues of patentable subject matter under 35 USC § 101.” The issues on appeal in Intervet Inc. v. Merial Ltd., related to claim construction and the doctrine of equivalents. Judge Dyk concurred-in-part and dissented-in-part with the majority’s decisions on claim construction, and disagreed with the majority’s view on the doctrine of equivalents, but wrote a separate opinion “primarily to make clear” that the fact that the court addressed the claim construction issues does not mean that the court had decided that the claims are directed to patent-eligible subject matter.
 

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A patent applicant will file a Request for Continued Examination (RCE) after a final Office Action in order to continue prosecution before the examiner, such as to make claim amendments and/or submit evidence that is not permitted under 37 CFR § 1.116 (which limits the amendments and evidence that will be admitted after final).  One focus of the Kappos administration has been to reduce the rate of RCE filings in general, and to address the problem of "RCE churning" by examiners.  However, a provision of the MPEP actually encourages an examiner practice that necessitates serial RCEs. If the USPTO is serious about reducing RCE churning, it should eliminate MPEP § 706.07(b).  

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Can the doctrine of equivalents be invoked to establish infringement of a claim that recites a numerical value?

Yes, according to the Federal Circuit’s decision in Adams Respiratory Therapeutics, Inc. v. Perrigo Co. 

Can the concept of significant digits be used to establish infringement?

Although the court does not say so directly, its opinion indicates that the answer to this question also is "yes."

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The Supreme Court’s Bilksi decision recognized three exceptions to 35 USC § 101: “laws of nature, physical phenomena, and abstract ideas.” The Federal Circuit’s decision in King Pharmaceuticals, Inc. v. Eon Labs., Inc. warns us that although satisfying the machine-or-transformation test might prove to be an effective antidote against § 101 defects, a patent claim still may be poisoned by 35 USC § 102 if the method at issue inherently flows from a prior art method—such as if it recites a newly discovered law of nature or physical phenomenon that naturally results from the prior art method.

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