`
`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`IN RE: URVASHI BHAGAT,
`Appellant
`______________________
`
`2016-2525
`______________________
`
`Appeal from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in No. 12/426,034.
`______________________
`
`Decided: March 16, 2018
`______________________
`
` URVASHI BHAGAT, Palo Alto, CA, pro se.
`
` NATHAN K. KELLEY, Office of the Solicitor, United
`States Patent and Trademark Office, Alexandria, VA, for
`appellee Andrei Iancu. Also represented by THOMAS W.
`KRAUSE, AMY J. NELSON.
`______________________
`
`Before NEWMAN, O’MALLEY, and TARANTO, Circuit Judges.
`NEWMAN, Circuit Judge.
`Urvashi Bhagat (“the Applicant”) appeals the decision
`of the Patent Trial and Appeal Board (“the Board”) affirm-
`ing 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,
`
`
`
`2
`
`
`
` IN RE: BHAGAT
`
`and 128–145 of U.S. Patent Application No. 12/426,034
`(“the ’034 application”).1 We affirm the Board’s decision.2
`BACKGROUND
`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, and that omega-6 and omega-3 fatty acids are
`naturally occurring in oils, butters, nuts, and seeds. The
`’034 application claims a range and ratios of these fatty
`acids and other limitations. Application claim 65 is the
`broadest claim:
`65. 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, con-
`tained 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 ac-
`ids are 0.1–30% by weight of total lipids;
`or
`(2) omega-6 fatty acids are not more than
`40 grams.
`Other claims add specificity of amounts or ratios, addi-
`tional ingredients, sources of the lipids, and delivery
`methods. The examiner held all of the claims unpatenta-
`
`1
`In re Bhagat, Appeal No. 2016–004154 (P.T.A.B.
`Apr. 15, 2016) (“Board Op.”).
`2 Applicant’s motions to expedite are denied as
`moot.
`
`
`
`IN RE: BHAGAT
`
`3
`
`ble as directed to products of nature, and also held most
`claims unpatentable as anticipated.
`The Board sustained the rejection of the claims, lead-
`ing to this appeal.
`
`DISCUSSION
`On review of the Board’s decision on an examiner’s re-
`jection, the Board’s legal determinations receive de novo
`review, and the Board’s factual findings are reviewed for
`support by substantial evidence in the examination
`record. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359,
`1363 (Fed. Cir. 2004). Claims in pending applications
`receive their broadest reasonable interpretation during
`examination, for adjustment of claim scope or clarification
`of meaning may be achieved by amendment during exam-
`ination.
`
`I
`ANTICIPATION
`A. 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.” Mark, col. 2, ll. 32–38;
`col. 4, ll. 21–23. Mark states that the omega-6 fatty acid
`“is present in a range of approximately 4–6% of the total
`calories” of the pediatric composition, and the omega-3
`fatty acid “is preferably present in the range of approxi-
`mately 0.8–1.2% of the total calories.” Id. at col. 4, ll. 27–
`31. Mark describes a specific composition containing 38.5
`grams of total lipids, id. at col. 6, l. 9, administered intra-
`
`
`
`4
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`
`
` IN RE: BHAGAT
`
`venously in a “typical feeding regimen” of “50 mL/hour for
`20 hours/day,” id. at col. 5, ll. 7–8.
`The Board agreed with the examiner that Mark dis-
`closes minimum and maximum amounts of omega-6 and
`omega-3 fatty acids within the claimed range, and also
`discloses a mixture of several types of oils as fatty acid
`sources. The Applicant argues that Mark does not “une-
`quivocal[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. The Board found that
`Mark expressly discloses an omega-6 to omega-3 fatty
`acid ratio of 5:1; Mark, col. 6, l. 15; which is within the
`ratios in all of the ’034 application claims. Board Op. at
`*19.
`The Applicant also argues 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. Responding to this
`argument, the Board found that Mark’s “typical feeding
`regimen” of “50 mL/hour for 20 hours,” a total of 1,000
`mL/day, meets the claim 65 “dosage,” for Mark’s daily
`dosage may include 1,000 mL, as the table in column 4
`refers to g/1,000 mL, teaching the daily amount fed to a
`child. Board Op. at *18. This finding is supported in the
`record, as is the Board’s resulting finding of anticipation
`of claims 65, 92–93, and 95 based on Mark’s feeding
`regimen within the dosage stated in these claims.
`The Applicant argues that even if the broadest claims
`are deemed anticipated by Mark, the other claims are not
`anticipated. The Applicant argues that Mark teaches a
`composition for children ages 1–10, and does not antici-
`pate claim 137 which states “the formulation is for a
`human infant, or adult.” The Board found this argument
`did not distinguish claim 137 because “Mark teaches
`pediatric patients which necessarily encompasses human
`
`
`
`IN RE: BHAGAT
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`5
`
`infants and children.” Board Op. at *26. We discern no
`error in the finding that claim 137, which includes “hu-
`man infants,” is anticipated by Mark’s reference to chil-
`dren ages 1–10.
`The Board received argument of the general unpre-
`dictability of components of natural products, and deemed
`this argument irrelevant because “the Examiner relies
`upon evidence of particular compositions of walnut oil or
`olive oil that satisfy the requirements of claim 65.” Board
`Op. at *11. This is a correct application of the law of
`anticipation, for compositions containing the components
`and ratios in claim 65 are shown in Mark for uses that
`include the pediatric use described in Mark. The Appli-
`cant’s claims are all directed to formulations and composi-
`tions, not to any asserted new use.
`The Board also found that while “casing” and “dosage”
`are not expressly defined, the specification states that any
`“orally accepted form” of delivery is within the scope of
`the claims. Board Op. at *9. The specification states that
`“the compositions comprising the lipid formulation dis-
`closed herein may be administered to an individual by
`any orally accepted form.” J.A. 65 ¶34. The Board found
`that the “casing” and “dosage” terms do not impart pa-
`tentability to the claimed compositions, and we agree, for
`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 Applicant also argues that Mark does not teach
`“steady delivery” as required by claim 78. Claim 78 states
`“the formulation provides gradual and/or steady delivery
`so that any omega-3 withdrawal is gradual, and/or any
`omega-6 and/or other fatty acid increase is gradual.” The
`Board found that claim 78 does not recite a patentably
`significant difference from Mark’s typical feeding regimen
`of 50 mL/hour for 20 hours. Board Op. at *24. The Appli-
`cant does not provide any distinction in claim 78 from
`
`
`
`6
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`
`
` IN RE: BHAGAT
`
`Mark’s typical feeding regimen, and does not overcome
`the Board’s finding of prima facie anticipation of claim 78
`by Mark.
`The PTO concedes that the Board incorrectly included
`claim 134 in the claims found to be anticipated by Mark.
`However, the PTO argues 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.
`B. 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,” http://web.archive.
`org/web/20060314112106/http://www.whfoods.com/genpag
`e.php?tname=nutrientprofile&dbid=111 (Mar. 14, 2006).
`The Olive Nutrient Analysis describes a one cup serv-
`ing of olives as containing omega-6 and omega-3 fatty
`acids in a 12:1 ratio. The Board agreed with the examin-
`er’s finding that the Olive Nutrient Analysis shows a
`serving size within the claimed dosage, and shows that
`olives contain a combination of lipids within the scope of
`the claims. The Olive Nutrient Analysis shows 1.14
`grams of omega-6 fatty acids in a one cup serving, which
`is within the limitation in all the claims that “omega-6
`fatty acids are not more than 40 grams.”
`The Board affirmed the examiner’s rejection except
`for claim 136, which the Board reversed with respect to
`the Olive Nutrient Analysis. Board Op. at *38. The
`Board held that the examiner had not established that
`olives contain the claimed combination with “one or more
`carriers selected from starches, sugars, granulating
`agents, binders and disintegrating agents.” Board Op. at
`*13–14, 32. However, the Board sustained the examiner’s
`rejection of claim 136 with respect to the Walnut Nutrient
`
`
`
`IN RE: BHAGAT
`
`7
`
`Analysis as that reference “teaches that walnuts contain
`sugars including disaccharides as required.” Board Op. at
`*37. On this appeal the PTO does not discuss claim 136
`with regard to olives, but argues that claim 136 is antici-
`pated by the Walnut Nutrient Analysis and invalid under
`Section 101.
`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,
`http://web.archive.org/web/20061109221127/
`http://whfoodw.com/genpage/php?tname=nutrientprofile&
`dbid=132 (Nov. 9, 2006). The Walnut Nutrient Analysis
`states that a 25 gram serving of walnuts contains omega-
`6 and omega-3 fatty acids in a 4.2:1 ratio. The Walnut
`Nutrient Analysis shows 9.52 grams of omega-6 fatty
`acids in a quarter-cup serving, which is within the limita-
`tion that “omega-6 fatty acids are not more than 40
`grams.” The Board agreed with the examiner that the
`reference’s serving size of walnuts contains a dosage of
`lipids within the scope of the claims. The Board affirmed
`all of the claim rejections on this Walnut reference.
`The Applicant states that the Board erroneously ig-
`nored a prosecution disclaimer of all compositions con-
`taining products from single sources such as olives and
`walnuts. The Applicant points out that all the claims are
`directed to formulations containing mixtures of omega-6
`and omega-3 fatty acids, and that the Walnut and Olive
`Nutrient Analyses do not describe the specific mixtures
`that limit all the claims; for example, the Claim 65 re-
`quirement that “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.” The Applicant also argues that the
`total lipids in these formulations are not described in the
`Walnut and Olive Nutrient Analyses. The Board found
`that all of the rejected claims include fatty acid quantities
`and ratios within the “dosages” in the Nutrient Analysis
`
`
`
`8
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`
`
` IN RE: BHAGAT
`
`references. The Board’s finding that the references’
`serving sizes of olives and walnuts meet the “dosages” in
`the claims is supported by substantial evidence in the
`record.
`The Applicant argues that a “serving” of olive oil or
`walnut oil, as reported in the Olive and Walnut Nutrient
`Analyses, is not a “dosage,” but merely a way to measure
`nutrient density. The Board found that the Applicant’s
`dosage is limited only in that the maximum content of
`omega-6 fatty acids is “not more than 40 grams,” Claim
`65, ante. The Board found that this is not a patentable
`distinction from the prior art, which shows omega-6 fatty
`acids in this range. We discern no error in this conclu-
`sion.
`The Board also considered the Applicant’s separate
`arguments of patentability of several of the dependent
`claims. The Applicant argues that the Olive Nutrient
`Analysis does not show the vitamin E ratio in claim 130
`(“vitamin E-alpha/gamma less than 0.5% by weight of
`total lipids”). However, the Board found that the Olive
`Nutrient Analysis states that the measured serving of
`olives contains 4.03 mg of “vitamin E alpha equiv” and
`14.35 g of total fat (lipids). Board Op. at *30. These
`amounts are within the scope of claim 130. The Applicant
`does not show error in the Board’s finding that the refer-
`ence shows a Vitamin E presence within the claimed
`range.
`For claims 67 and 68 the Board found that the protein
`in walnuts and olives meets the “protein source” desig-
`nated in these claims. The Board found that the Walnut
`Nutrient Analysis includes protein and carbohydrates as
`recited in claim 67, and “the protein in walnuts is not
`derived from the prohibited sources of claim 68.” Board
`Op. at *35–36. Claim 78 recites “steady” delivery, e.g.,
`“[t]he formulation of claim 65, whereby the formulation
`provides gradual and/or steady delivery so that any
`
`
`
`IN RE: BHAGAT
`
`9
`
`omega-3 withdrawal is gradual, and/or any omega-6
`and/or other fatty acid increase is gradual.” Claims 73,
`74, 98, 118, 122, 137 and 140 add limitations directed to
`intended use. Claims 96 and 97 include limitations of
`additional nutrients and polyphenols.
`The Board found 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. These
`findings are supported by substantial evidence in the
`cited references. The examiner’s prima facie case of
`anticipation by these known fatty acid compositions and
`uses was not rebutted by the Applicant. See In re Oetiker,
`977 F.2d 1443, 1445 (Fed. Cir. 1992) (the burden of pre-
`senting an initial prima facie case of unpatentability is on
`the examiner, after which the burden of coming forward
`with rebuttal evidence shifts to the applicant; the ulti-
`mate burden of proof of unpatentability is with the exam-
`iner).
`
`II
`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. The examiner found
`that the claimed “intermixture of lipids from different
`sources” is “structurally indistinct” from lipid formula-
`tions derived from a single source, as shown in the prior
`art. The examiner also found that the claims are directed
`to natural products of walnut oil and olive oil, and that
`the additional limitations in the claims do not change the
`characteristics of the products, or add “significantly more”
`to the claims.
`The Applicant argues that it “disclaimed” the claim
`scope of compositions from a single source, thus avoiding
`not only anticipation, but also Section 101. The Applicant
`
`
`
`10
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`
` IN RE: BHAGAT
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`states that the Board erred in rejecting all of the claims
`as directed to a product of nature, arguing 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 single source natural
`products.
`The Applicant also argues that the claimed limita-
`tions of “dosage” and “casings providing controlled deliv-
`ery” do not exist as natural products. The Applicant
`states that natural products cannot provide a controlled
`delivery or dosage because lipid profiles in nature are
`unpredictable. The Applicant also states that walnut oil
`and olive oil are not “natural products,” for they can be
`obtained only by treatment of natural products.
`Claim 128
`The Applicant also argues that claim 128 is distin-
`guished 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 held that admixture
`with other natural products of known composition 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 combination of species produces no
`new bacteria, no change in the six species of bacteria, and
`no enlargement of the range of their utility. . . . They
`serve the ends nature originally provided and act quite
`independently of any effort of the patentee.”).
`The Board correctly held that claim 128 does not
`avoid the rejection on the ground that the claims are
`directed to known natural products.
`Claims 102, 107, and 119
`The examiner and the Board did not specifically in-
`clude claims 102, 107, and 119 in the rejection for antici-
`
`
`
`IN RE: BHAGAT
`
`11
`
`pation, as the PTO recognizes, stating that “Bhagat
`advances arguments regarding olives and walnuts for
`claims 102, 107, and 119. Bhagat Br. 77–78. The Board
`did not issue a rejection for these claims based on either
`olives or walnuts.” PTO Br. 38 n.10. However, the PTO
`states that these claims were properly rejected under
`Section 101.
`Claim 102 recites specific ratios of polyunsaturated,
`monounsaturated, and saturated fatty acids. Claims 107
`and 119 present the fatty acid content recited in claims 98
`and 91, respectively, in Tables in the specification. The
`Board observed that the servings of olive oil and walnut
`oil shown in the references contain omega-6 and omega-3
`fatty acids in amounts within the Applicant’s claimed
`ranges. Thus 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 differ-
`ent source would necessarily impart characteristics to the
`formulation which were absent when a single source was
`used.” Board Op. at *8.
`The Applicant argues 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. The Applicant points to the ’034 specifi-
`cation’s statements that the claimed mixtures provide
`benefits of “synergy” and “avoid concentrated delivery of
`specific phytochemicals that may be harmful in excess,”
`J.A. 62 ¶30. The Board held that these arguments do 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 include this lipid content. The Board
`pointed out that the specification does not distinguish the
`
`
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`12
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`
` IN RE: BHAGAT
`
`claimed omega-3 and omega-6 fatty acids, from the ome-
`ga-3 and omega-6 fatty acids that exist in nature, and
`that the Applicant has not provided evidence of such
`distinction.
`The Applicant argues that while naturally occurring
`plants or their isolated lipids may be natural products,
`extracts and composites or mixtures are not natural
`products because the extraction processes required to
`obtain edible oils from olives and walnuts transform the
`claimed lipids from natural products. The Board found,
`and we agree, that the Applicant has not shown 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.
`The Board concluded that the claims are directed to
`the omega-6 and omega-3 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. We have considered all of the
`Applicant’s arguments, and conclude that substantial
`evidence supports the Board’s findings, and the rulings of
`unpatentability.
`
`AFFIRMED
`
`No costs.
`
`