March 29, 2018
Urvashi Bhagat appealed the decision of the PTAB (“the Board”) affirming the examiner’s anticipation rejections and the rejection under Section 101 of multiple claims in application 12/426,034. The Federal Circuit affirmed the Board’s decision in the recent In re Urvashi Bhagat nonprecedential opinion. The claims of this application were directed to lipid-containing formulations comprising omega-6 and omega-3 fatty acids. The ’034 application stated that dietary deficiency or imbalance of these fatty acids might lead to a variety of illnesses, and that omega-6 and omega-3 fatty acids are naturally occurring in oils, butters, nuts, and seeds. The ’034 application claimed ranges and ratios of the fatty acids and other limitations.
Claim 65 recited:
A lipid-containing formulation, comprising a dosage of omega-6 and omega-3 fatty acids at an omega-6 to omega-3 ratio of 4:1 or greater, contained in one or more complementing casings providing controlled delivery of the formulation to a subject, wherein at least one casing comprises an intermixture of lipids from different sources, and wherein (1) omega-6 fatty acids are 4–75% by weight of total lipids and omega-3 fatty acids are 0.1–30% by weight of total lipids; or (2) omega-6 fatty acids are not more than 40 grams.
Other claims included specific amounts and/or ratios, additional components, sources of the lipids, and delivery methods.
Under Section 101, the examiner rejected the claims (and the Board agreed) as being directed to non-statutory subject matter, because the claimed fatty acid mixtures occur naturally in walnut oil and olive oil. The Patent Office did not provide a clear step-by-step analysis under Section 101, as required by its own guidelines, and merely offered a mixed and brief statement that the claimed “intermixture of lipids from different sources” is “structurally indistinct” from lipid formulations derived from a single source, as shown in the prior art. The examiner found that the claims were directed to natural products of walnut oil and olive oil, and that the additional limitations in the claims did not change the characteristics of the products, or add “significantly more” to the claims. The Applicant offered a number of arguments for patent eligibility but the court agreed with the Board.
The Applicant’s arguments for patent eligibility included statements that the claimed “intermixture of lipids from different sources” does not occur in nature and that the properties of the claimed formulations from different lipid sources are different from the properties of natural products from a single source. The Applicant pointed to the specification describing that the claimed mixtures provide benefits of “synergy” and “avoid concentrated delivery of specific phytochemicals that may be harmful in excess.” The Applicant further argued that the claimed mixtures of fatty acids from different sources were “structurally different” from the single-source walnut oil and olive oil. However, the Applicant apparently did not offer evidence to bolster this argument. The Applicant explained that while naturally occurring plants or their isolated lipids might be natural products, extracts and composites or mixtures are not natural products because the extraction processes required for obtaining edible oils from olives and walnuts transform the claimed lipids from natural products. However, the Board held that the arguments did not overcome the identity of the claimed products and the naturally occurring lipid profiles of walnut oil and olive oil. The Board cited the references showing the lipid content of natural walnut oil and olive oil, and pointed out that the claims included this lipid content. The Board stated that the specification did not distinguish the claimed omega-3 and omega-6 fatty acids, from the omega-3 and omega-6 fatty acids that exist in nature, and that the Applicant did not provide evidence of such distinction. The court agreed that the Board properly found that Bhagat failed to show that the claimed mixtures were a “transformation” of the natural products, or that the claimed mixtures had properties not possessed by these products in nature.
The Applicant further argued that the claimed limitations of “dosage” and “casings providing controlled delivery” do not exist as natural products, that natural products cannot provide a controlled delivery or dosage because lipid profiles in nature are unpredictable and that walnut oil and olive oil are not “natural products,” as they can be obtained only by treatment of natural products. Here, the court seems to rely on the anticipation section of the opinion for the analysis under Section 101. In the anticipation analysis, the court agreed with the Board that the terms “casing” and “dosage” do not provide patentability to the compositions because “the specification states that these claim elements are not limiting and does not describe any assertedly novel characteristics of these components or their formulations.” The court also agreed that the claims were directed to fatty acids that occur in nature and “that the asserted claim limitations do not distinguish the claimed products and compositions from those shown in the cited references.” Thus, the analysis under section 102 was apparently applied to the analysis under Section 101. However, as explained by the Supreme Court in Mayo, the analysis under section 101 is separate from the patentability analysis under sections 102 or 103. Here, the main claim appears to include limitations that are not nature-based or that add “significantly more” to the nature-based product, e.g., the limitations “dosage” and “casings providing controlled delivery” are not found in nature and natural counterpart products and the claimed mixture “avoids concentrated delivery of specific phytochemicals that may be harmful in excess.”
Another rejected claim 102 recited specific ratios of polyunsaturated, monounsaturated, and saturated fatty acids. The Board observed that the servings of olive oil and walnut oil shown in the references cited by the PTO in the anticipation rejections contained omega-6 and omega-3 fatty acids in the amounts within the claimed ranges. The Board held that the “intermixture of lipids from different sources” does not distinguish the claims from natural products because the Applicant “has not provided adequate evidence that an oil from different sources would necessarily have a composition that is different from one from the same source, nor that a different source would necessarily impart characteristics to the formulation which were absent when a single source was used.”
The Applicant also argued that claim 128 was distinguished from natural products, and was not anticipated based on the limitation that the compositions contain “nuts or their oils” obtained from “almonds, peanuts, and/or coconut meat.” However, the Board held that admixture with other natural products of known compositions was not shown or stated to change the nature of the compositions, citing Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948). The court simply agreed that the Board correctly held that “claim 128 does not avoid the rejection on the ground that the claims are directed to known natural products.”
Thus, the court concluded that substantial evidence supported the Board’s findings and the rulings of unpatentability.
In re Urvashi Bhagat, Appeal No. 2016-2525 (Fed. Cir., March 16, 2018)
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012)