Court Opinion

ID: 4255503
Source: CourtListenerOpinion
Date Created: 2018-03-16 15:01:00.154707+00
Date Added: 2024-06-11T14:17:21.259456
License: Public Domain

NOTE: This disposition is nonprecedential.

  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                                            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                                             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                                             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                                            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                                           IN RE: BHAGAT

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
12                                           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.