OBJECTIVELY SPEAKING – OBVIOUSNESS REQUIRES OBJECTIVE EVIDENCE
In Ex Parte Judy Hattendorf and Steve Carlson, Appeal 2010-010918 decided December 24, 2010, the Board of Patent Appeals and Interferences (BPAI) reversed an Examiner’s obviousness rejection of claims of the application because the Examiner failed to show sufficient objective evidence to support his finding of prima facie obviousness.
Under long-standing precedent, an examiner’s conclusion that a claimed subject matter is prima facie obvious and therefore unpatentable must be supported by clear objective evidence that is, a teaching in the prior art that evidences that one having ordinary skill in the art would have been motivated to combine the relevant teachings of the references relied on by the examiner to arrive at the claimed invention and/or reasonably would have expected success in arriving at the claimed invention by combining the relevant teachings apparent from the references or other sources.
The claims involved a method of preconditioning skin of a person prior to radiation or photodynamic therapy skin cancer treatment by the sequential topical application of a composition to the area of the skin, whereby “preconditioning the skin reduces side effects associated with the skin cancer treatment compared to skin that is not preconditioned for receiving a skin cancer treatment.”
In rejecting the claims as obvious, the primary examiner relied on several prior art references that disclosed preconditioning skin before and after cosmetic surgical procedures and a reference that disclosed various radiation and photodynamic skin cancer treatments. The examiner’s position on appeal was that, since radiation and PDT skin cancer treatment, as well as chemical peels, eye-lifts, and laser resurfacing causes skin damage and/or irritation that can be mitigated by the preconditioning procedures disclosed, one having ordinary skill in the art would be motivated to use such skin preconditioning procedures with a radiation and PDA skin cancer treatment as claimed to reduce the side effects associated with such treatment. Specifically, the examiner found that Karen taught that the Nu-Derm® System of preparing and correcting the skin “restores skin health prior to surgery and builds skin tolerance to ensure a much better surgical result and allows for quicker healing time.” According to the examiner, “Karen differed from the instant invention [only] in that the subject’s skin was preconditioned for skin rejuvenating procedures rather than for radiation or photodynamic therapy skin cancer treatment.”
On appeal, this posed an interesting question to the BPAI, which had to determine whether or not the Examiner properly established by objective evidence that one having ordinary skill in the art would have been motivated to precondition the skin of a subject in accordance with the prior art teachings related to non-skin cancer treatment (i.e., skin rejuvenation treatments) in order to minimize the complications of known radiation and photodynamic therapy skin cancer treatments.
The BPAI held that the examiner did not provide sufficient objective evidence to establish that it would be obvious to a skilled person that a method of restoring skin prior to skin rejuvenation surgery would be an obvious expedient in reducing the side effects associated with the claimed radiation and photodynamic skin cancer treatment. As stated in the Board’s opinion:
[T]he Examiner has failed to identify an evidentiary basis to support this reasoning. Specifically, what is missing from the Examiner’s rejection is some objective teaching in the prior art or some finding of ordinary skill in the art that the complications or side effects resulting from radiation therapy disclosed in Nguyen would have been reduced in a subject that preconditioned their skin according to the method disclosed in Karen or the Obagi Brochure. Without this evidence, prima facie obviousness is not established.
Thus, applicant prevailed in overcoming the examiner’s rejection by showing how his analysis had an apparent hole in its logic – namely, a missing link between known skin pre-treatment for minimizing adverse effects of skin rejuvenating procedures and the concept of preconditioning skin to reduce side effects associated with radiation and photodynamic skin cancer treatment as compared to skin that is not preconditioned for receiving such skin cancer treatment, as claimed. Close question? The examiner possibly still believes so.
Read/download the decision here
Prepared by Thomas Lee