IP Law Daily Patent claims for fatty acid mixtures invalid as directed to products of nature
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Friday, March 16, 2018

Patent claims for fatty acid mixtures invalid as directed to products of nature

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

Numerous claims of patent applicant Urvashi Bhagat’s patent claiming a range and ratios of omega-6 and omega-3 fatty acids and other limitations were correctly found by the Patent Trial and Appeal Board to be unpatentable as directed to products of nature, and many of them unpatentable as anticipated, the U.S. Court of Appeals for the Federal Circuit has decided. Thus, a decision of the PTAB was affirmed (In re Bhagat, March 16, 2018, Newman, P.).

Bhagat’s U.S. Patent Application No. 12/426,034 (the ’034 application) is directed to lipid-containing compositions comprising omega-6 and omega-3 fatty acids. The ’034 application states that dietary deficiency or imbalance of these fatty acids may lead to a variety of illnesses. It claims a range and ratios of these fatty acids and other limitations.

The Board affirmed the examiner’s rejection of claims 52, 61, 64, 65, 67–69, 73–75, 77, 78, 80, 82, 83, 90–102, 107, 116–122, 124, and 128–145 of the ’034 application. Bhagat appealed.

The Mark reference. The Board affirmed the examiner’s rejection of claims 52, 61, 64, 65, 67–69, 73, 75, 77, 78, 80, 83, 90, 92–96, 98, 100, 129–131, 133, 135–137, 142 and 144 on the ground of anticipation by U.S. Patent No. 5,549,905 (Mark). Mark describes a nutritional composition for pediatric patients, including a protein source, carbohydrate source, and lipid source containing omega-6 and omega-3 fatty acids in a ratio of "approximately 4:1 to 6:1."

Bhagat argued that Mark does not "unequivocal[ly]" disclose the claimed omega-6 to omega-3 ratio because Mark does not clearly state whether its compositions are total omega-6 and omega-3 acids, or only alpha-linolenic and linoleic acids. Bhagat also argued that Mark does not meet the "dosage" limitation of claim 65 because Mark discloses concentrations of nutrients, rather than a dosage of omega-6 and omega-3 fatty acids. The applicant also argued that Mark teaches a composition for children ages 1–10, and does not anticipate claim 137 which states "the formulation is for a human infant, or adult."

The Federal Circuit rejected all of these arguments, finding that the Board did not err in finding that Mark expressly discloses an omega-6 to omega-3 fatty acid ratio of 5:1; which is within the ratios in all of the ’034 application claims. Additionally, Mark’s expressed "typical feeding regimen," for example of "50 mL/hour for 20 hours," a total of 1,000 mL/day, met the dosage limitations in the stated claims, the appellate court held. Further, there was no error in the Board’s finding that claim 137, which includes "human infants," is anticipated by Mark’s reference to children ages 1–10. All of the applicant’s other arguments based on the Mark reference, with the exception to those regarding claim 134, were similarly without merit.

The USPTO conceded that the Board incorrectly included claim 134 in the claims found to be anticipated by Mark. However, the USPTO argued that claim 134 is anticipated by the Walnut Nutrient Analysis on the same basis as for the other claims, and also is unpatentable under Section 101, the court noted.

The Olive and Walnut Nutrient Analyses. The examiner rejected claims 52, 61, 64, 65, 67–69, 73–75, 77, 78, 80, 82, 83, 90, 92–94, 96–98, 100, 129–131, 133, 136, 137, 142, and 144 as anticipated by the nutrient profile of a serving of olives, whose fatty acid composition is shown in "Olive Nutrient Analysis." The Olive Nutrient Analysis describes a one cup serving of olives as containing omega-6 and omega-3 fatty acids in a 12:1 ratio. The examiner rejected claims 52, 61, 64, 65, 67–69, 73–75, 77, 78, 80, 83, 90–101, 116–118, 120–22, 124, 128–140, and 141–145 as anticipated by the nutrient profile of a serving of walnuts as reported in the Walnut Nutrient Analysis.

Bhagat contended that the Board erroneously ignored a prosecution disclaimer of all compositions containing products from single sources such as olives and walnuts. The Federal Circuit rejected this, and related arguments, holding that The Board’s finding that the references’ serving sizes of olives and walnuts meet the "dosages" in the claims was supported by substantial evidence. The Board did not err in finding that all of the additional limitations are known aspects used in known conditions, as shown in Mark or in the Olive or Walnut Nutrient Analysis, the court ruled. These findings were supported by substantial evidence in the cited references.

Section 101. The examiner and the Board also held that all of the claims are directed to non-statutory subject matter under Section 101, because the claimed fatty acid mixtures occur naturally in walnut oil and olive oil. Bhagat argued that he "disclaimed" the claim scope of compositions from a single source, thus avoiding not only anticipation, but also Section 101. The court was not persuaded.

As for Claim 128, Bhagat also argued that claim 128 is distinguished from natural products, and is not anticipated based on the limitation that the compositions contain "nuts or their oils" obtained from "almonds, peanuts, and/or coconut meat." The Board correctly held that claim 128 does not avoid the rejection on the ground that the claims are directed to known natural products, the appellate court said.

As for claims 102, 107, and 119, Bhagat argued that the Board erred, and that the claimed mixtures of fatty acids from different sources are "structurally different" from the single-source walnut oil and olive oil. However, the Board properly found that Bhagat failed to show that the claimed mixtures are a "transformation" of the natural products, or that the claimed mixtures have properties not possessed by these products in nature. Substantial evidence supported the Board’s findings, and the rulings of unpatentability.

The case is No. 2016-2525.

Attorneys: Urvashi Bhagat, pro se. Nathan K. Kelley, U.S. Patent and Trademark Office, for Andrei Iancu.

MainStory: TopStory Patent FedCirNews

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