On October 10, 2007, the U.S. Patent and Trademark Office (“USPTO”) published notifications concerning its new patent rules and standards for patent examination. First, the USPTO issued its guidelines for the examination of patent applications for obviousness in light of the U.S. Supreme Court’s recent decision in KSR International Co. v. Teleflex Inc.1 Second, the USPTO published “clarifications” to the patent rules changes that go into effect on November 1, 2007, along with the implementation of transitional provisions to govern applications already pending prior to that date.

Patent Examination Guidelines for Obviousness

The Examination Guidelines,2 which are effective October 10, 2007, do not have the force and effect of law, but purportedly “will assist USPTO personnel to make a proper determination of obviousness under 35 U.S.C. 103 to provide an appropriate supporting rationale.” The Guidelines first describe the KSR decision and the principles of the law of obviousness. The Guidelines then describe the so-called Graham factors, explaining that “[a]s reiterated by the Supreme Court in KSR, the framework for the objective analysis for determining obviousness under 35 U.S.C. 103 is stated in Graham v. John Deere Co....”3 In that decision, the Court explained that obviousness is a question of law based on the following underlying factual inquiries: (1) determining the scope and content of the prior art, (2) ascertaining the differences between the claimed invention and the prior art, and (3) resolving the level of ordinary skill in the art The Guidelines indicate that “Office personnel [e.g., patent examiners and administrative law judges] fulfill the critical role of factfinder when resolving the Graham inquiries.” The Guidelines state that the following factors may be considered in determining the level of ordinary skill in the art: (1) type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) the educational level of active workers in the field. The Guidelines also provide that “Office personnel may rely on their own technical expertise to describe the knowledge and skills of a person of ordinary skill in the art.”

The Guidelines then state that after resolving the Graham factors, “office personnel must determine whether the claimed invention would have been obvious to one of ordinary skill in the art...and must explain why the difference(s) between the prior art and the claimed invention would have been obvious…” The Guidelines emphasize that “the key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious.” The Guidelines articulate seven different rationales that a patent examiner may rely upon to support an obviousness rejection. These rationales are:

  • prior art elements are combined according to known methods to yield predictable results;
  • one known element is substituted for another to obtain predictable results;
  • known techniques are used to improve similar devices, methods, or products in the same way;
  • a known technique is applied to a known device, method, or product ready for improvement to yield predictable results;
  • the claimed invention was “obvious to try,” as by choosing from a finite number of identified, predictable solutions with a reasonable expectation of success;
  • known work in one field prompted variations of it in the same or different field based on design incentives or other market forces and the variations would have been predictable to one of ordinary skill in the art; or
  • some teaching, suggestion, or motivation in the prior art would have led one of ordinary skill in the art to modify a prior art reference or combine prior art reference teachings.

The Guidelines also describe how a patent applicant should reply once “Office personnel have established the Graham factual findings and concluded that the claimed invention would have been obvious.” The patent applicant must either point out with particularity the error in the Office’s findings or provide other evidence that the claimed invention would have been nonobvious. The Guidelines acknowledge that “applicants are likely to submit evidence to rebut the fact finding made by Office personnel” and that applicants may submit evidence or argument to demonstrate that (1) one of ordinary skill in the art could not have combined the claimed elements by known methods (e.g., due to technological difficulties); (2) the elements in combination do not merely perform the function that each element performs separately; or (3) the results of the claimed combination were unexpected. Rebuttal evidence also may include evidence of “secondary considerations” such as commercial success, a long felt but unsolved need, and failure of others.

In view of these Guidelines, patent applicants responding to an obviousness rejection will need to provide a well reasoned reply, preferably coupled with documentary evidence to counter the Office’s purported “factual findings” and legal conclusion. For example, errors in the findings may be shown by evidence contradicting the patent examiner’s determination of the level of ordinary skill in the art, such as evidence of a lack of prior art solutions to a problem or the slow progress of innovations in the field. In addition, evidence of countervailing design incentives or other market forces may be useful in resolving the level of ordinary skill in the art. Evidence of technological difficulties in combining the claimed elements, evidence that a claimed combination does more than merely perform the function that each element of the combination performs separately, and comparative test data or other evidence showing surprisingly or unexpectedly positive results can be particularly useful evidence for establishing nonobviousness.

Inventors, patent applicants and their attorneys should be cognizant of these Guidelines at all stages of invention development and patenting, so that rebuttal evidence can be accumulated contemporaneously and comparative testing can be conducted in a timely manner, in anticipation of the need to respond to an obviousness rejection. For example, inventors should consider documenting, at the early stages of developing an inventive solution, the types of problems encountered; prior art solutions to those problems; the rapidity with which innovations are made in the field; the sophistication of the technology; and the educational level of active workers in the field. Furthermore, inventors should consider documenting evidence of surprising or unexpected results as an invention is reduced to practice and evaluated.

Clarifications and Transitional Provisions of the New Patent Rules

On November 1, 2007, the USPTO’s patent rules governing continuation practice, claims, and multiple applications with patentably indistinct claims will be substantially changed. According to the rules as published on August 21, 2007, the rule changes would apply to any patent application already filed and still pending on that date. The USPTO’s notice published on October 10, 2007, clarifies certain provisions of the new rules and modifies other provisions in them.

First, a waiver has been given to the extent that any divisional application, continuing application of a divisional application, or a “bypass” continuing application of a Patent Cooperative Treaty (“PCT”) international application will not count against the "one more" continuing application count.4 The Office does not intend for an otherwise proper divisional application to count for or against the transitional “one more” continuation application provided under the new rules for existing patent application families.

Second, the USPTO has partially waived the rule that requires submission of an Identification Statement5 to notify the Patent Office of all other commonly owned patents and applications that share a common inventor and a filing or priority date within 2 months of a pending application. For applications filed before November 1, 2007, the applicant needs to identify only those cases where the subject application has the same filing or priority date as other commonly owned patents and applications that share a common inventor. The rule applies in full to all applications filed on or after November 1, 2007.

Third, the USPTO has waived or delayed the requirement for submission of the continuation-in-part (“CIP”) identification statement. Under the new rules, an applicant must identify the claim or claims in the CIP application that are fully supported in the prior application. The requirement has been waived for applications for which a first office action on the merits has been mailed before November 1, 2007. For pending CIP applications without a first office action on the merits before November 1, 2007, the filing date for this Statement has been extended from November 1, 2007 to February 1, 2008.6

Lastly, the USPTO has clarified that the term “examined” in the definition7 of a divisional application (e.g., the claimed subject matter has not been previously examined) does not include international phase examination under PCT Article 31. This clarification was needed to preserve an applicant’s ability to file a divisional application in a U.S. national phase application in response to a restriction requirement where preliminary examination of the non-elected claims occurred in the international stage.