IP Law Daily, PATENT—Fed. Cir.: Patent Board’s finding that psoriasis treatment method was obvious reversed on appeal, (Nov 25, 2013)

By Peter Reap, J.D., LL.M.

The USPTO’s Patent Trial and Appeal Board erred in affirming an examiner’s rejection of all claims in U.S. Patent Application No. 11/145,716 (“the '716 application”) for a vitamin supplement composition of folic acid, vitamin B12, and vitamin B6, the U.S. Court of Appeals for the Federal Circuit has determined (In re Eaton, November 22, 2013, Per Curiam). A factual error in both the examiner’s and the Board’s analysis of the prior art tainted their obviousness determination. Thus, the Board’s anticipation and obviousness determinations were reversed and the case remanded for further proceedings.

Background. On June 6, 2005, Kevin Eaton filed the '716 application, entitled “Treatment of Dermatological Conditions.” The '716 application claims a method of treating psoriasis by administering a multiple vitamin supplement composition. The claims-at-issue on appeal are claims 1, 8, 9, and 10. Those claims recite a vitamin supplement composition of folic acid, vitamin B12, and vitamin B6 and further recite that the composition is “essentially free of anti-oxidants.”

The examiner rejected the '716 application’s claims as anticipated or obvious in view of five prior art references. Relevant to the claims-at-issue, the examiner rejected claim 1 under 35 U.S.C. § 102(b) as anticipated by DE Patent No. 10053155 A1 (“Jungkeit”). The examiner rejected claims 1 and 8-10 under 35 U.S.C. § 103(a) as obvious in view of Jungkeit and U.S. Patent No. 6,107,349 (“Mantynen”).

Jungkeit was filed in 2000 and discloses the use of a multivitamin preparation for the treatment of psoriasis. The preparation specifically contains vitamin B1, vitamin B2, nicotine amide, dexpanthenol, biotin, folic acid, vitamin B6, vitamin B12, and two known antioxidants: vitamin C and vitamin E. Mantynen was filed in 1998 and discloses the “use of a novel composition comprising Vitamin E, evening primrose oil and B-complex vitamins.”

The Board found that the specification defines the phrase “essentially free of anti-oxidants” to “allow antioxidants as long as they do not damage or inactivate the B12 or folic acid.” Thus, the Board agreed with the examiner that claim 1 of the '716 application could be “reasonably interpreted to allow for 200 μg of vitamin C” because “Jungkeit’s composition containing 200 μg of vitamin C was effective [at] treat[ing] psoriasis.” However, Jungkeit actually discloses 200 mg of Vitamin C, the Federal Circuit noted. Similarly, because the applicant’s arguments concerning the obviousness rejections relied on the same “essentially free of anti-oxidants” arguments, the Board found them unpersuasive.

Eaton appealed the Board’s anticipation rejection of claim 1 on the ground that “Jungkeit does not describe a vitamin composition that is essentially free of anti-oxidants” and thus cannot anticipate claim 1. Similarly, Eaton appealed the Board’s obviousness rejection of claims 1 and 8-10 over Jungkeit and Mantynen because “Mantynen fails to rectify the deficiencies of Jungkeit.”

Claim construction. The Board’s affirmance—and the examiner’s rejections—turned on the meaning of the claim limitation “essentially free of antioxidants,” the court noted. The parties disputed the construction of this phrase. However, both parties acknowledged that the specification defines “essentially free of antioxidants” functionally to mean that the claimed composition “should not contain an amount of antioxidants which would tend to damage and inactivate some of the vitamin B12 and/or folic acid of the vitamin supplement.”

The specification goes on to state that “lower amounts of antioxidants” may be present if they do not render the claimed composition “ineffective or [] reduce[] effectiveness.” The parties’ disagreement stemmed from the fact that the specification does not, however, quantify what is a “lower amount[]” or what “amount of antioxidants [] would tend to damage or inactivate” the vitamin B12 or folic acid, but instead relies on functionality.

Referring to the specification, the Board correctly determined that “essentially free” of antioxidants means a composition that “should not contain an amount of antioxidants which would tend to damage and inactivate some of the vitamin B12 and/or folic acid of the vitamin supplement.” The construction does not require “no” added vitamin C, vitamin E, or the like. Rather, the correct construction requires that “lower amounts” of antioxidants may be present, but the effectiveness of the composition must not be reduced, according to the court.

Anticipation. A review of the Board’s decision revealed that the Board was not faithful to this construction, the court decided. To anticipate, it was not enough for the prior art composition to have an amount of antioxidant that merely allows the composition to be “effective.” To anticipate, the prior art compositions must have an amount of antioxidant that did not result in “reduced effectiveness.” Substantial evidence supported the Board’s finding that “Jungkeit treated psoriasis with a composition comprising B6, B12, and folic acid in the requisite amounts.” However, substantial evidence did not support the Board’s finding that Jungkeit’s composition was “essentially free of antioxidants,” the court held. The Board and the examiner did not analyze the prior art for reduced effectiveness.

The Board and examiner assumed, without any rationale, that because Jungkeit states that its composition was effective at treating psoriasis, Jungkeit’s use of 200 mg of vitamin C would meet the applicant’s definition of “essentially free of antioxidants.” Jungkeit’s disclosed compositions could be effective, but still had an amount of antioxidant that “inactivate[s] some of the vitamin B12 and/or folic acid.” In short, the fact that Jungkeit’s composition was not “ineffective” did not mean that it read on the “essentially free of antioxidants” limitation. To fall within the scope of the claims, the prior art composition must also not have a reduced effectiveness due to the presence of antioxidants. The Patent Office did not establish that the cited references disclosed compositions whose effectiveness was not reduced at all due to the presence of the antioxidants, the court explained.

The Board’s decision was particularly problematic given a clear factual error appearing in both the examiner’s and the Board’s analysis of Jungkeit. Specifically, Jungkeit disclosed 200 milligrams of vitamin C—not 200 micrograms, as stated by the examiner. The Office’s analyses repeatedly relied on the understanding that “Jungkeit’s composition contain[ed] 200 μg of vitamin C.” In truth, Jungkeit disclosed 1000 times that much vitamin C—200 mg. This error was not harmless, the court reasoned. Indeed, Jungkeit taught the use of vitamin C in a significantly greater quantity than any of the other nine components in Jungkeit’s claimed composition. Thus, substantial evidence could not support a finding that Jungkeit met the “essentially free of antioxidants” element.

Obviousness. The Board adopted the examiner’s reasoning that it would have been obvious for one of ordinary skill to “adjust the concentrations of folic acid, vitamin B6, and vitamin B12 to arrive at an optimum workable range.” However, this finding did not provide a rationale for adjusting the concentrations of antioxidants in Jungkeit or Mantynen to be “essentially free of antioxidants,” the court held. Here, the Board’s factual error regarding the amount of antioxidant present in Jungkeit tainted its obviousness conclusion. In fact, both Jungkeit and Mantynen disclosed compounds where the concentration of antioxidants was greater than the concentrations of either folic acid or the B-vitamins.

The Office failed to establish on this record that a motivation existed to modify Jungkeit or Mantynen to be essentially free of antioxidants. The amount of vitamin C in Jungkeit’s claimed composition was over three times greater than the next-most prevalent component. Similarly, Mantynen disclosed a “novel composition” comprising a known antioxidant—vitamin E—evening primrose oil, and B-complex vitamins. The record demonstrated neither a motivation to “adjust” those synergistic concentrations nor a motivation to combine them. Therefore, the Board’s obviousness determination was reversed.

The case is No. 2013-1104.

Attorneys: Casey L. Griffith (Klemchuk Kubasta, LLP) for Kevin P. Eaton. Nathan K. Kelley, Deputy Solicitor, USPTO.

Cases: Patent FedCir