Ex Parte Bhagat

Patent Trial and Appeal Board

Apr 15, 2016

12426034 (P.T.A.B. Apr. 15, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/426,034 04/17/2009 Urvashi Bhagat
111481 7590 04/15/2016
Asha Nutrition Sciences, Inc,
P.O. Box 1000
Palo Alto, CA 94302
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
3947
EXAMINER
HEYER, DENNIS
ART UNIT PAPER NUMBER
1628
MAILDATE DELIVERY MODE
04/15/2016 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte URV ASHI BHAGAT
Appeal2016-004154
Application 12/426,034
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
JOHN G. NEW, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to lipid-
containing formulations. The Examiner rejected the claims as directed to a
product of nature and as anticipated. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.
1 Appellant identifies the Real Party in Interest as Asha Nutrition
Sciences, Inc. (see App. Br. 3).
Appeal2016-004154
Application 12/426,034
Statement of the Case
Background
"Linoleic acid (LA) and Alpha-linolenic Acid (ALA) are the
precursors for all omega-6 and omega-3 fatty acids. It is well established that
LA and ALA are 'essential' fatty acids" (Spec. i-f 4). "Dietary deficiency or
excess of the two essential fatty acids may cause many illnesses" (Spec. i-f 4).
The Claims
Claims 52, 61, 64, 65, 67----69, 73-75, 77, 78, 80, 82, 83, 90-102, 107,
116-122, 124, and 128-145 are on appeal. Independent claim 65 is
representative and reads as follows:
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, 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.
The Issues
A. The Examiner rejected claims 52, 61, 64, 65, 67-69, 73-75, 77, 78,
80, 82, 83, 90-102, 107, 116-122, 124, and 128-145 under 35 U.S.C. § 101
as directed to non-statutory subject matter (Ans. 6-22).
B. The Examiner rejected claims 52, 61, 64, 65, 67----69, 73, 75, 77, 78,
80, 83, 90, 92-96, 98, 100, 129-131, 133-137, 142, and 144 under
2
Appeal2016-004154
Application 12/426,034
35 U.S.C. § 102(b) as anticipated by Mark2 (Ans. 47-53).
C. 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
under 35 U.S.C. § 102(b) as anticipated by Olives3 as evidenced by "Olives
Nutrient Analysis"4 (Ans. 65-72).
D. The Examiner rejected claims 52, 61, 64, 65, 67-69, 73-75, 77, 78,
80, 83, 90-101, 116-118, 120-122, 124, 128-140, and 141-145 under
35 U.S.C. § 102(b) as anticipated by Walnuts5 as evidenced by "Walnut
Nutrient Analysis"6 (Ans. 73-83).
A. 35 U.S.C. § 101
The Examiner finds that
a one ounce serving of walnut oil (28 grams, i.e. a 'dosage')
is a lipid-containing formulation that contains 28 gm of fatty
acids (lipids) and~ 50 mg of "other" lipids .... The ratio of
omega-6 to omega-3 fatty acids is 5.09: 1 (i.e. 4: 1 or greater).
Walnut oil contains 14.81 grams (52.8% by weight; i.e.
2 Mark et al., US 5,549,905, issued Aug. 27, 1996 ("Mark").
3 Olives, web.archive.org/web/20060314112112/
http://www.whfoods.com/genpage.php?pfriendly=l&tname=foods
pice&dbid=46 (Mar. 14, 2006). We refer to pages by number in
sequential order.
4 Olives Nutrient Analysis, web.archive.org/web/20060314112106/
http://www.whfoods.com/ genpage. php ?tname=nutrientprofile&dbi
d= 111 (Mar. 14, 2006).
5 Walnuts, http://www. whfoods. com/ gen page. php ?tname=
foodspice&dbid=99 (Nov. 9, 2006).
6 Walnut Nutrient Analysis, http://web.archive.org/web/
20061109221127/http://www.whfoods.com/genpage.php?tname=n
utrientprofile&dbid=132 (Nov. 9, 2006).
3
Appeal2016-004154
Application 12/426,034
between 4 and 75% by weight of total lipids, or, greater than
20% by weight of total lipids) of omega-6 fatty acids.
Walnut oil contains 2.91 grams (10% by weight of total
lipids) of omega-3 fatty acids.
(Ans. 12). The Examiner finds that "walnut oil is a judicial exception (i.e. a
product of nature)" (Ans. 18) and that "the claimed composition does not
have markedly different characteristics from what occurs in nature" (Ans.
16).
Appellant contends that
The claims include several elements that add significantly
more than what occurs in nature, such as "intermixtures of
lipids from different sources", "a dosage of omega-6
/omega-3 fatty acids", "a ratio of omega-6 to omega-3 fatty
acids of 4: 1 or greater" or "omega-6 fatty acids greater than
20% by weight of total lipids", "contained in one or more
complementing casings providing controlled delivery of the
formulation to a subject," with defined "dosages" and
defined concentrations.
(App. Br. 8).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that the claims are drawn to
products of nature, a class of non-statutory subject matter?
Findings of Fact
1. The Specification teaches that "the lipid formulation disclosed
herein may be administered to an individual in any orally accepted form"
(Spec. ii 34).
2. The Specification teaches that the "fatty acid components of the
composition's lipid contents are achieved at least in part by using one or
4
Appeal2016-004154
Application 12/426,034
more of the following concentrated lipid sources: oils, butters, nuts, and
seeds" (Spec. i-f 9).
3. The Specification teaches that "synergy among complementing
nutrients from different sources may be incorporated. Furthermore, using
different sources avoids concentrated delivery of specific phytochemicals
that may be harmful in excess" (Spec. i-f 30).
4. The Erickson Declaration 3/31/157 states "'[d]ifferent sources'
refers to different oils, butters, nuts, seeds, herbs, sweeteners, and/or other
foods and/or their different varieties (containing different lipid profiles)"
(Erickson Deel. 3/31/15 i-f 6; cf Rucker Deel. 4/30/158 i-f 6); and Das Deel.
4/30/159 ,-r 6).
5. The Erickson Declaration 3/31/15 states that "each walnut (or
olive) would not be considered to be a different source of lipids from one
another by skilled artisans, unless one specific variety of walnut (or olive) is
added to another, different, specific variety of walnuts (or olives) to enhance
usefulness of the walnut (or olive) formulation" (Erickson Deel. 3/31/15 i-f 7;
cf Rucker Deel. 4/30/15 i-f 9; and Das Deel. 4/30/15 i-f 9).
6. The Erickson Declaration 1/31/1410 states that "[l]ipid content,
including omega-6 and omega-3, of products of nature is extremely variable.
This variability depends on the source, background genetics, cultivating
conditions, including soils, fertilizer used, and other variable factors, such as
hours of sunlight and water composition" (Erickson Deel. 1/31/14 i-f 3).
7 Declaration of Dr. Kent L. Erickson, dated May 31, 2015.
8 Declaration of Dr. Robert B. Rucker, dated Apr. 30, 2015.
9 Declaration of Dr. Undurti N. Das, dated Apr. 30, 2015.
10 Declaration of Dr. Kent L. Erickson, dated Jan. 31, 2014.
5
Appeal2016-004154
Application 12/426,034
7. Walnut Oil Nutrition Facts 11 teaches that walnut oil contains
14810 mg omega-6 fatty acids and 2912 mg omega-3 fatty acids resulting in
a ratio of approximately 5: 1 omega 6 to omega 3 fatty acids with less than
40 grams of omega-6 fatty acids (Walnut Oil Nutrition Facts 2).
8. Olive Oil Nutrition Facts12 teaches that olive oil contains 2734
mg omega-6 fatty acids and 213 mg omega-3 fatty acids resulting in a ration
of~ 12.8: 1 omega 6 to omega 3 fatty acids with less than 40 grams of
omega-6 fatty acids (Olive Oil Nutrition Facts 2).
Principles of Law
In Funk Bros., "bacteria produced by the laboratory methods of
culture are placed in a powder or liquid base and packaged for sale to and
use by agriculturists in the inoculation of the seeds of leguminous plants."
Funk Bros. Seed Co. v. Kaloinoculant Co., 333 U.S. 127, 129 (1948). "The
qualities of these bacteria, like the heat of the sun, electricity, or the qualities
of metals, are part of the storehouse of knowledge of all men. They are
manifestations of laws of nature, free to all men and reserved exclusively to
none." Id. at 130.
"[E]xtensive effort alone is insufficient to satisfy the demands of
§ 101. Nor are Myriad's claims saved by the fact that isolating DNA from
the human genome severs chemical bonds and thereby creates a nonnaturally
occurring molecule." Ass 'nfor Molecular Pathology v. Myriad Genetics,
Inc., 133 S. Ct. 2107, 2118 (2013). "Myriad's claims are simply not
11 Oil, vegetable, walnut, http://nutritiondata.self.com/facts/fats-
and-oils/589/2 (accessed Feb. 11, 2015).
12 Oil, olive, salad or cooking, http://nutritiondata.self.com/facts/
fats-and-oils/509/2 (accessed Feb. 11, 2015).
6
Appeal2016-004154
Application 12/426,034
expressed in terms of chemical composition, nor do they rely in any way on
the chemical changes that result from the isolation of a particular section of
DNA." Id.
Analysis
i. Claim Interpretation
We begin with claim interpretation of the disputed claim phrase
"intermixture of lipids from different sources" in claim 65 regarding the
meaning of "different sources" and whether "intermixture of lipids"
represents a product-by-process limitation.
"intermixture of lipids"
Claim 65 is drawn to a "lipid-containing formulation," not a process
for making the composition. The weight of authority holds that the
patentability of product-by-process claims is not dependent on process
limitations. See In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985) ("even
though product-by-process claims are limited by and defined by the process,
determination of patentability is based on the product itself'; "[t]he
patentability of a product does not depend on its method of production"; and
"[i]f the product in a product-by-process claim is the same as or obvious
from a product of the prior art, the claim is unpatentable even though the
prior product was made by a different process.")
We agree with the Examiner that "any prior art lipid-containing
formulation from a single source that occurs in nature but appears to be
structurally the same, i.e. contains the same lipid components ... is
considered to read on these claims" (Ans. 4; emphasis omitted). Appellant
does not identify any necessary structural differences in the final "lipid-
7
Appeal2016-004154
Application 12/426,034
containing formulation" that results based upon the use of an "intermixture
of lipids from different sources." For example, Appellant does not explain
or provide evidence that a container of olive oil pressed from a single tree of
Kalamata olives necessarily differs in lipid content from a container of
blended olive oil pressed from an intermixture of different varieties of olives
such as Kalamata, Nicoise, Picholine, and Manzanilla olives (see Olives 3).
We recognize, but find unpersuasive, Appellant's reliance upon the
Erickson Declaration 3/31/15 teaching that "when lipids from different
sources are intermixed, the resulting mixture will necessarily have different
physical and chemical properties from a 'single' source" (Erickson Deel.
3/31/15 i-f 8; cf App. Br. 16-17). It is the composition which is being
claimed. Appellant 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.
If the term "different sources" is read so narrowly as to require any
differences, distinguish single component or "intermixture" sources, then the
Examiner's broad interpretation discussed above demonstrates natural
products with "different sources." Alternatively, if the "intermixture" refers
to the final product, which may be obtained in different ways by adding
different amounts of components to obtain the desired composition, then the
Examiner's product-by-process reasoning applies.
8
Appeal2016-004154
Application 12/426,034
"casing" and "dosage"
The Specification does not provide a definition of the term "casing,"
expressly stating that any "orally accepted form" falls within the scope of
the invention (FF 1 ). Additionally, claim 65 does not require any particular
dosage of the formulation, so long as there are not more than 40 grams of
omega-6 fatty acids.
Considering claim 65 as a whole, we agree with the Examiner that
whether the lipid-containing formulation with a "dosage" of omega-6 and
omega-3 fatty acids in a "casing" and derived from an "intermixture of lipids
from different sources" is interpreted as a product-by-process claim (see
Ans. 4).
ii. Product of Nature
We are constrained by the Supreme Court decisions in Funk Bros. and
Myriad to agree with the Examiner that walnut oil is a "product of nature"
falling within the judicial exception to patentable subject matter.
In Funk Bros., "products of nature" included bacteria that were
"produced by the laboratory methods of culture" and "placed in a powder or
liquid base and packaged for sale to and use by agriculturists in the
inoculation of the seeds of leguminous plants." Funk Bros. Seed Co., 333
U.S. at 129. Thus, the Supreme Court did not find routine production and
extraction steps resulted in a product that was "markedly different" from the
product of nature.
In Myriad, "products of nature" included isolated DNA that was
extracted from cells and required "sever[ing] chemical bonds and thereby
creat[ing] a nonnaturally occurring molecule." Myriad, 133 S. Ct. at 2118.
9
Appeal2016-004154
Application 12/426,034
Again, the Supreme Court did not find that routine production and extract
steps resulted in a product, finding that the "processes used by Myriad to
isolate DNA were well understood by geneticists at the time of Myriad's
patents." Id. at 2119.
Appellant contends that walnut "oil extraction is a complex multi-step
process during which physical and chemical properties of the plant seeds,
such as walnuts and olives, transform dramatically producing oils and by-
products" (App. Br. 9). Appellant contends that "[t]hus, extracted oils,
including Walnut Oil and Olive Oil are man-made products not products of
nature and they have markedly different characteristics than products of
nature, such as some walnuts/olives" (App. Br. 11 ).
We are not persuaded. The Examiner notes that "there are no
limitations in the claims requiring any alleged sources of lipids to be
prepared by the oil extraction processes described" (Ans. 23) and the
ordinary artisan would recognize that some oils, like extra virgin olive oil,
are "the initial unrefined oil from the first pressing" (Olives 3).
We recognize, but find unpersuasive, Appellant's contention that
"isolated individual omega-6, omega-3, other fatty acids, or other lipids, or
naturally occurring plant/animal parts are judicial exceptions, but composites
of such matters are not judicial exceptions" (App. Br. 12). Consistent with
Supreme Court precedent, some processing such as the walnut oil refining,
may not result in a "markedly different" product as evidenced by the
laboratory culture, powder, and packaging of bacteria in Funk Bros. or the
chemical isolation and cleavage of DNA in Myriad. We see no principled
reasoning that supports finding walnut or olive oil "markedly different"
10
Appeal2016-004154
Application 12/426,034
while finding the packaged and powdered bacteria of Funk Bros. or the
isolated DNA of Myriad not "markedly different."
We recognize, but find unpersuasive, Appellant's contention that
"even within the same species lipid content, including omega-6 and omega-
3, of natural plant seeds and their oils cannot be predicted" (App. Br. 20). In
this case, the Examiner relies upon evidence of particular compositions of
walnut oil or olive oil that satisfy the requirements of claim 65 (FF 7-8).
That other natural compositions may not fall within the scope of the claim is
irrelevant because the exception is to any product of nature, not all products
of nature.
We recognize, but find unpersuasive, Appellant's contention that the
"products of instant claims serve the function of solving a long-felt critical
unmet need" (App. Br. 21; cf App. Br. 32-33). Long-felt need and
secondary considerations are doctrines related to obviousness that do not
apply to either utility or anticipation. See Cohesive Techs., Inc. v. Waters
Corp. 543 F.3d 1351, 1364 (Fed. Cir. 2008) ("[O]bviousness requires
analysis of secondary considerations of nonobviousness, while secondary
considerations are not an element of a claim of anticipation.")
We recognize, but find unpersuasive, Appellant's contention that the
"Examiner has rebuffed overwhelming evidence and testimony of skilled
persons regarding the presence of not well-understood, non-routine, and
non-conventional features in the claimed formulations, which confers patent
eligibility based on case law" (App. Br. 22; emphasis omitted). Rather, the
Examiner, constrained by Funk Bros. and Myriad, carefully considered the
Declarations of Dr. Erickson, Rucker, and Das (see Ans. 26, 30, 31, 38) but
11
Appeal2016-004154
Application 12/426,034
found the evidence supported the§ 101 "product of nature" rejection. We
have also carefully reviewed these expert Declarations, and find them
unpersuasive for the reasons given above.
We recognize, but find unpersuasive, Appellant's contention that the
prior art "specifically teaches against high omega-6 to omega-3 ratios, and
places emphasis on low ratios of the fatty acids not amounts/dosages" (App.
Br. 23; emphasis omitted). Just as "[t]eaching away is irrelevant to
anticipation." Seachange Int'!, Inc., v. C-COR, Inc., 413 F.3d 1361, 1380
(Fed. Cir. 2005), teaching away is also irrelevant to the issue of patentable
subject matter. Either the claims read on products of nature or they do not.
We recognize, but find unpersuasive, Appellant's contention that "the
prior art neither understood the importance of omega-6, nor its relationship
with other lipids; and the prior art routinely recommended use of other lipids
that suppress omega-6 activity" (App. Br. 28). This argument is irrelevant to
the issue of statutory subject matter and utility, because significant or not,
the issue is whether the claimed formulation reads on a "product of nature"
not whether that formulation has unexpected properties.
Appellant separately argue the limitations of dependent claims 67 and
68 (App. Br. 35), but do not rebut the Examiner's finding that "there is no
evidence in the specification that combining walnut oil with any source of
naturally occurring proteins and carbohydrates, in any amounts, results in a
marked change in function" (Ans. 19). The Examiner's reasoning is
consistent with Funk Bros., where the combination of natural occurring
bacteria did not overcome the lack of statutory subject matter. See Funk
Bros., 333 U.S. at 131 ("The bacteria perform in their natural way. Their use
12
Appeal2016-004154
Application 12/426,034
in combination does not improve in any way their natural functioning. They
serve the ends nature originally provided and act quite independently of any
effort of the patentee.")
Appellant argues that claim 77 differs as "one-part or [comprises]
multi-part" components (App. Br. 35). We are not persuaded because the
walnut or olive oils teach one ounce serving sizes that are reasonably
interpreted as one-part dosages (see Walnut Oil 1).
Appellant contends that claims 78 and 124 "cannot be said to provide
steady delivery of the claimed formulation" (App. Br. 35). Appellant
provides no evidence that the natural compositions fail to satisfy this claim
limitation. See In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)
(Arguments and conclusions unsupported by factual evidence carry no
evidentiary weight.)
Appellant points to limitations in claims 102, 107, and 119, but does
not identify any evidence that these limitations distinguish from the
disclosed walnut or olive oils.
Appellant contends, regarding claim 128, that "at least some varieties
of almonds, peanuts, and coconuts, and their oils, have no omega-3 content
at all, and that their omega-6 concentration is at most 32%" (App. Br. 36).
We find this argument unpersuasive because the claim 128 is drawn to a
formulation that may include olive oil and walnut oil expressly, and
Appellant has provided no evidence of necessary structural difference based
on the product-by-process language. In re Thorpe, 777 F.2d at 697.
Appellant contends regarding claims 136 and 139 that regarding
starches and sugars, "[t]here is no evidence that any product of nature meets
13
Appeal2016-004154
Application 12/426,034
this requirement" (App. Br. 36). We agree with the Examiner that "[t]here is
no evidence of record that including, for example, ANY naturally occurring
sugar or starch, in ANY amount, with the lipid-containing formulations of
Claims 65 and 91 would result in a marked change in the characteristics of
walnut oil (or olive oil)" (Ans. 45). The Examiner's reasoning remains
consistent with Funk Bros., where the combination of natural occurring
bacteria did not overcome the lack of statutory subject matter. See Funk
Bros., 333 U.S. at 131.
We remain unpersuaded by Appellant's reiteration of their argument
on the scope of "intermixed" for claims 142 and 144 for the reasons already
given above (see App. Br. 36).
Conclusion of Law
The evidence of record supports the Examiner's conclusion that the
claims are drawn to products of nature, a class of non-statutory subject
matter.
B. 35 U.S.C. § 102(b) over Mark
The Examiner finds that:
Mark teaches the detailed lipid profile of the 38.5 g lipid
component in the one liter ( 1000 ml) oral pediatric
composition (column 4, lines 40 - 60) as containing 12.2%
omega-6 fatty acids and 2.4% omega-3 fatty acids based on
total lipids, thus meeting limitation ( 1) recited in instant
Claims 65 and limitation (i) and (ii) of instant Claim 83.
Further, it is noted that the amount by weight of omega-6
fatty acids is 4.70g (12.2% of 38.5 g) and the amount by
weight omega-3 fatty acids is 0.924 g (38.5 g x 2.4%) which
meets limitation (2) recited in instant Claim 65.
(Ans. 48).
14
Appeal2016-004154
Application 12/426,034
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Mark anticipates the claims?
Findings of Fact
9. Mark teaches "a nutritional composition designed for pediatric
patients" (Mark, col. 1, 11. 65---66).
10. Mark teaches "a lipid source comprising a mixture of medium
and long chain triglycerides. The lipid source includes an omega-3 to
omega-6 fatty acid ratio of approximately 4: 1 to 6: 1" (Mark, col. 2, 11. 35-
38).
11. Mark teaches that a "lipid profile containing such long chain
triglycerides is designed to have a polyunsaturated fatty acid omega-6 (n-6)
to omega-3 (n-3) ratio of approximately 4: 1 to 6: 1" (Mark, col. 4, 11. 21-23).
12. Mark teaches that in "an embodiment, the n-6 to n-3 fatty acid
ratio is approximately 5: 1. Both the omega-6 and omega-3 fatty acids are
provided in sufficient quantity to meet tissue growth maintenance needs"
(Mark, col. 4, 11. 23-27).
13. Mark teaches that "the source of omega-6 fatty acids is present
in a range of approximately 4---6% of the total calories. The omega-3 fatty
acid source is preferably present in the range of approximately 0.8-1.2% of
the total calories" (Mark, col. 4, 11. 27-31 ).
14. Mark teaches "an example of a fatty acid lipid profile that may
be used in the composition of the present invention will now be given.
15
Appeal2016-004154
Application 12/426,034
UP!D
C6:0
C8;0
C10:0
Cl2'.f)
C14:0
CHl:O
ClB:O
TOTAL SAT
C16:1
Cl!U
!OTALMONO
Cl8:2t16
Cl8'.3 nJ
TOTAL POLY
TOTAL
(Mark, col. 4, 11. 35-60).
LIPID PROFILE (385 git)
% of
Total. F.'L
I········-······---····----·················· .....
1BASIC MACRONUTRIENTS AND CALORIES
b~,,,m~;·:··; l~~"r7f ;j
llf:~1_~_1~~~1 _- .... _______ · _____ T1::.~_-_6_._:_g_g_·._-~_:_:_·._· .. ·._·_··_1_._1_._~--2_._~_b_-_1
~i~-t~~ ~:i_~~r ··-·-·-·-·-·-·-·-·-· ,
! CalOri~S . . --- _ ........... ····-··-··-·-· .. .. . , 154-56 ·--·-· 8-:.~~l
INDIVIDUAL FATTY ACIDS
resulting in~ 12: 1 ratio of omega-6 to omega-3 ("Olives Nutrient Analysis"
1, 5).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of "Olives" and "Olive Nutrient Analysis" (Ans. 65-72;
FF 17-18) and agree that the claims are anticipated. We address Appellant's
arguments below.
Appellant contends that "[t]here is no suggestion in Olives or ONA
regarding an intermixture of lipids [fatty acids] from different varieties or
sources" (App. Br. 53).
We do not find this argument persuasive for the reasons extensively
addressed above. To briefly recap, the limitation to "intermixture of lipids
from different sources" is a product-by-process limitation that imposes no
specific structure on the lipid-containing formulation. Thorpe, 777 F .2d at
697.
28
Appeal2016-004154
Application 12/426,034
Appellant contends that "it is improper to construe the feature
'intermixtures of lipids [fatty acids] from different sources' as product-by-
process" (App. Br. 55).
We do not find this argument persuasive because Appellant has not
demonstrated a difference between a can of black olives composed of the
Kalamata variety from a can of black olives of the Manzanilla variety. This
is the essence of product-by-process because the final formulation differs
only in the process by which it is made, but contains the same omega-3 to
omega-6 fatty acid ratio in the same amounts as required by the claims.
Appellant contends that "the webpages that disclose 'Olives' and
'ONA' teach mixtures of foods, including lipids from different sources,
wherein overall ratio of omega-6 to omega-3 is around 2: 1" (App. Br. 55).
Appellant contends that "[t]hree skilled persons have testified, 'This
teaching is applicable to all food mixtures taught by the site.' See paragraph
[0010] of the Rucker, Rustagi, and Das declarations submitted on October 1,
2014" (App. Br. 55).
We are not persuaded. The teaching of "WHFoods"13 is that the
"ideal ratio of omega-3 to omega-6 is not known, but is estimated to be
around 1 :2; whereas, the current ratio in the typical American diet is more
like 1 :25" ("WHFoods" 9). This is not relevant to the amounts of omega-3
and omega-6 fatty acids in a specific food such as a serving of olives.
Further, the Declarations simply contend that "authoritative guidelines do
13 WHFoods: A New Way of Looking at Proteins, Fats and
Carbohydrates, http://web.archive.org/web/20070104020351/
http://whfoods.com/gen page. php?tname=faq&dbid=7 (accessed
Apr. 12, 2014).
29
Appeal2016-004154
Application 12/426,034
not recognize the significance of 'total lipids' as a category" (Rucker Deel.
4/30/15 i-f 13; cf Erickson Deel. 3/31/15 i-f 20; Das Deel. 4/30/15 i-f 13;
Rustagi Deel. 9/29/14 14 i-f 10), but provide no evidence that olives in cans for
consumptions lack the required omega-3 and omega-6 fatty acids in the
required ratio.
Appellant contends that "the practitioner is neither motivated nor
taught to modify ONA ... in order to obtain total lipids or a ratio of omega-6
and/or omega-3 to total lipids."' (App. Br. 56).
We are not persuaded because the rejection is for anticipation, not
obviousness. The Examiner cites "Olive Nutrient Analysis" to evidence that
olives contain 14.35 g total fat composed in part of 0.09 g omega-3 fatty
acids and 1.14 g of omega-6 fatty acids, "resulting in~ 12: 1 ratio of omega-
6 to omega-3" (FF 18). Appellant provides no evidence in rebuttal, nor do
the Declarants specifically contest the composition disclosed by "Olive
Nutrient Analysis."
Claim 130
Appellant contends that "Claim 130 requires presence of additional
features that add to the novelty over 'Olives' and 'ONA"' (App. Br. 57).
We are not persuaded because the Examiner finds that "it is noted that
Olives contains 4.03 mg vitamin E (less than 0.5% total lipids)" (Ans. 89), a
finding that is not rebutted by Appellant.
14 Declaration of Dr. Pradip K. Rustagi, dated Sept. 29, 2014.
30
Appeal2016-004154
Application 12/426,034
Dependent Claims
We recognize, but find unpersuasive, Appellant's arguments
regarding claim 67 (App. Br. 58) because "Olive Nutrient Analysis" teaches
that olives contain protein and carbohydrates (FF 18).
We recognize, but find unpersuasive, Appellant's arguments
regarding claim 68 (App. Br. 58) because "protein in olives and walnuts ...
is less than 7 5% are from legumes, and less than 15% are from other
sources" (Ans. 89). That is, the protein in olives is not derived from the
prohibited sources of claim 68.
We recognize, but find unpersuasive, Appellant's argument regarding
claims 73 and 74 (App. Br. 58) because the claims impose no specific
structural requirement on the formulation, and the "when the formulation is
provided" or "supplies 60-90% of a diet's fat calories" limitations represent
intended uses. However, a "mere statement of a new use for an otherwise
old or obvious composition cannot render a claim to the composition
patentable." Zierden, 411 F.2d at 1328.
We recognize, but find unpersuasive, Appellant's argument regarding
claim 77 (App. Br. 58) because the olive composition may be administered
in one-part "serving size" for any desired period of time (FF 18).
We recognize, but find unpersuasive, Appellant's argument regarding
claim 78 (App. Br. 59) because Appellant provides no evidence
demonstrating that the delivery of omega-3 or omega-6 fatty acids is not
gradual or steady. See Best, 562 F.2d at 1255 ("Where, as here, the claimed
and prior art products are identical or substantially identical ... the PTO can
31
Appeal2016-004154
Application 12/426,034
require an applicant to prove that the prior art products do not necessarily or
inherently possess the characteristics of his claimed product.").
We recognize, but find unpersuasive, Appellant's argument regarding
claims 96 and 97 (App. Br. 59) because "Olive Nutrient Analysis" teaches
the presence of additional nutrients (FF 18) and "Olives" teaches that "olives
contain a variety of beneficial active phytonutrient compounds including
polyphenols" (Olives 1 ). Appellant provides no evidence that the
formulation does not inherently satisfy the functional requirements of claims
96 and 97. Best, 562 F.2d at 1255.
We recognize, but find unpersuasive, Appellant's argument regarding
claim 98 (App. Br. 59) because it represents intended uses of the
formulation. Zierden, 411 F.2d at 1328. No specific structural limitations
are imposed by claim 98.
We find Appellant's argument regarding claim 136 (App. Br. 59)
persuasive because the Examiner has not established the presence of any of
the listed carriers in olives.
We recognize, but find unpersuasive, Appellant's argument regarding
claim 137 (App. Br. 59) because olives may be consumed by adults.
We recognize, but find unpersuasive, Appellant's argument regarding
claim 142 (App. Br. 60) because the olives contain fatty acids that are
necessarily either in the free or ester form.
We recognize, but find unpersuasive, Appellant's argument regarding
claim 144 (App. Br. 60) that olives are not an "intermixture" for the reasons
already given above.
32
Appeal2016-004154
Application 12/426,034
Appellant also lists claims 61, 68, 69, 95, 102, 107, 142, and 144 but
provides no specific arguments. "A statement which merely points out what
a claim recites will not be considered an argument for separate patentability
of the claim." 37 C.F.R. § 41.37(c)(l)(iv). Here, Appellant does not
identify the claim recitations and provides no specific arguments that
"Olives" does not anticipate these claims.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
"Olives" as evidenced by "Olive Nutrient Analysis" anticipates the claims.
D. 35 U.S.C. § 102(b) over Walnuts and "Walnut Nutrient Analysis"
The Examiner finds that "'Walnuts' teaches ... amounts and health
ratings of certain nutrients present in a 0.25 cup serving of walnuts" (Ans.
73). The Examiner finds that "a 0.25 cup serving of walnuts contain: 1) 9.52
g omega-6 fatty acids (54% by weight of total lipids) and 2.27 g omega-3
fatty acids (13.9 % by weight of total lipids)" (Ans. 77).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that "Walnuts" as evidenced by
"Walnut Nutrient Analysis" anticipates the claims?
Findings of Fact
19. Walnut teaches "[w]alnuts are a delicious way to add extra
nutrition, flavor and crunch to a meal" and that "several polyphenolic
compounds [are] found in walnuts" (Walnut 1 ). Walnut teaches that "three
of the main types of walnuts consumed are the English (or Persian) walnut,
Juglans regia; the Black walnut, Juglans nigra; and the White (or butternut)
walnut, Juglans cinerea" (Walnut 4).
33
Appeal2016-004154
Application 12/426,034
20. "Walnut Nutrient Analysis" teaches 25 g serving size contains
Basic Comp0A<:>nt!;
nutrient
nutrient
("Walnut Nutrient Analysis" 1, 3).
Analysis
amount
ilmoull't
163.S!l
14~.:n
13.78
J.lll ~
3.43 g
.L6(l 9
CL-40 Q
O.Sl g 1
n.fi~ Qi
o.oo g
U.!iJ 9
1.10 g
1