Ex Parte Bertoldo de Barros et al

Patent Trial and Appeal Board

Sep 24, 2018

13405920 (P.T.A.B. Sep. 24, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/405,920 02/27/2012
97462 7590 09/24/2018
Mark A. Litman & Associates, P.A.
7001 Cahill Road, Ste. ISA
Edina, MN 55439
FIRST NAMED INVENTOR
Regina Celia Bertoldo de Barros
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.
621.002US2 3767
EXAMINER
FIEBIG, RUSSELL G
ART UNIT PAPER NUMBER
1655
MAIL DATE DELIVERY MODE
09/24/2018 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 REGINA CELIA BERTOLDO DE BARROS,
MICHELE ANN MAJESKI, FREDERIC JOHN RIGELHOF,
and LEE KENT FRENCH 1
Appeal2017-009906
Application 13/405,920
Technology Center 1600
Before DONALD E. ADAMS, JOHN G. NEW, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state that the real party-in-interest is Suntava, LLC. App. Br. 3.
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Application 13/405,920
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1-17 and 20-30, which stand rejected
as unpatentable under 35 U.S.C. § 101 as being directed to nonstatutory
subject matter.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to the extraction of anthocyanin
pigments/ dyes from natural, hybrid, or inbred com kernels by adding com
kernels with less than 5% by weight of com kernels comprising broken
kernels to an aqueous medium to form an aqueous-com medium. Abstr.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. An aqueous composition comprising an extraction product
from unbroken designed species hybrid com kernels comprising an
aqueous composition separated from the unbroken com kernels having
at least 0.5% by weight of anthocyanin content in water of the aqueous
composition the anthocyanin content characterized as having less than
65 % by weight of non-acylated anthocyanin and at least 3 5% by weight
of acylated anthocyanin and at least 11 chromatographic peaks
representing distinct anthocyanin compounds.
App. Br. 28.
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ISSUES AND ANALYSES
We are persuaded by, and expressly adopt, the Examiner's findings,
reasoning and conclusions establishing that Appellants' claims are prima
facie directed to nonstatutory subject matter. We address the arguments
raised by Appellants below.
Issue
Appellants argue that the Examiner erred in finding that Appellants'
claims are directed to a phenomenon of nature and are, consequently,
unpatentable. App. Br. 10.
Analysis
The Examiner finds that Appellants' claims are directed to a
composition of matter and, therefore, to patentable subject matter. Final
Act. 2-3. However, the Examiner finds, the claims are directed to one of the
judicially-created exceptions to subject matter eligibility, viz., a natural
phenomenon. Id. at 3. Specifically, the Examiner finds, the claims are
directed to an extraction product comprising the recited anthocyanin content
which is not markedly different from the closest naturally-occurring
counterpart, i.e., an extraction product with anthocyanin content from
"natural" com kernels. Id.
The Examiner notes that all of the ingredients recited in the claims are
natural products that would naturally exist in the com; therefore, the
Examiner finds, the claims involve a judicial exception. Final Act. 3. The
Examiner finds that, when given the broadest reasonable interpretation,
Appellants' claims are of broad scope. Id. The Examiner observes that the
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claim term "designed species hybrid" is meant to distinguish the fact that the
com kernels are genetically modified; however, it is not the genetic material
that is being claimed, but, rather, the extraction product. Id. The Examiner
finds that there is no indication in the record of any markedly different
characteristics of the extract product of the "designed species hybrid" com
kernels from the extract product of "natural" com kernels, or of a structural
difference between the claimed extract product with the anthocyanin content
and the naturally-occurring extract product with anthocyanin content. Id. In
other words, the Examiner finds, there is no evidence of record that the
genetic modification has resulted in any evident structural changes in the
extract product. Id. Consequently, the claimed extract product and
compositions are structurally the same as naturally-occurring counterparts.
Id. at 3--4.
The Examiner further finds that a change in the ratio or amount of
extract does not transform the claims into an exemption from the judicial
exception, because amounts/ratios/percentages do not set forth a "markedly
different" structure when compared to the naturally-occurring product. Final
Act. 4 (citing, e.g., Diamond v. Chakrabarty, 447 U.S. 303 (1980)). The
Examiner finds that combining naturally-derived ingredients does not
amount to a claim which surmounts the judicial exception. Id. ( citing Funk
Bros. Seed Co. v. Kato Inoculant Co., 333 U.S. 127 (1948)). The Examiner
therefore concludes that the claims are directed to the "natural phenomenon"
exception to Section 101 and are, consequently, not patentable.
Finally, the Examiner finds, the claims are directed to a water extract
composition without any other components that could add significantly more
to the exception. Final Act. 5.
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Appellants argue that the Examiner's rejection poses a conundrum in
that the hybrids are admitted in the rejection that they are not "natural" under
Myriad, but that, upon extraction, the residue ( extraction product) is not
patent-eligible solely because it is, in the Examiner's findings
indistinguishable from some theoretical extraction product from another
"natural" com kernel source. App. Br. 10-11. According to Appellants, the
rejection assumes availability in a natural state of a single natural com kernel
that is capable of providing the specific spectrum of anthocyanin dye
proportions recited in the claims. Id. at 11. Appellants contend that this
assumption is not supported by evidence of record. Id. Appellants argue
that the Examiner assumes that there exists, somewhere in the world, a com
kernel that, if extracted, would produce an extraction composition
anticipating the composition recited in the claims, thus providing evidence
that the claims are directed to a natural product. Id. Rather, Appellants
argue, their claimed composition is a "natural product" only in the sense that
each individual component may be naturally occurring, but that the
combination is unique in nature, especially in conjunction with its being
carried in a water composition without chemical modification or in
admixture with ingredients in addition to the extract. Id. ( emphasis added).
Appellants argue further that the extraction process itself, by use of
water, has created a unique composition of matter. App. Br. 12. According
to Appellants, the original anthocyanins as claimed exist within cellular
structure of the artificial (i.e., hybrid) com kernel cells in admixture with
additional plant content material. Id. Furthermore, Appellants assert, the
proportions are also the unique result of the mild, non-chemical extraction of
the anthocyanins. Id.
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Appellants note that, during prosecution, they amended the claims to
add a substantive limitation ad that all claims are now limited to "hybrids,"
"hybrids from crosspollination," "designed species," or "designed hybrid."
App. Br. 15 ( citing Spec. 2, 20). Appellants also point out that claim 22
recites specific and patented designed hybrids ( e.g., F AR045 or F AR601 2).
Id. Appellants argue that none of these are natural phenomena. Id.
Appellants argue further that, in addition to the "inherent ambiguity"
of the term "phenomenon of nature," claim 1 recites an "unnatural
combination of proportions of materials within chemical classes." App. Br.
16. As proof of this argument, Appellants assert that a) these materials do
not exist in those proportions within any known species of natural com
kernels; b) the unique combination and proportions of anthocyanin
compounds provides a stability of the ingredients and the product; c) the
process leaves an essentially whole kernel by-product that is itself stable and
of higher commercial value than ground kernel residue from other types of
extraction processes; and d) the capability of producing an extract product
that is capable of being defined as legally "organic." Id. at 17.
Finally, Appellants argue that, in addition to the claimed composition
being not a natural product, and the relative composition of the composition
not being found in "natural" strains of com, the claimed composition has
advantageous and unexpected properties not known in the prior art, viz., an
improved stability against hydrolysis, the claims do not substantially
foreclose others from using the exception. App. Br. 17-19.
2 F AR045 and F AR061 are inbred lines of maize. See Spec. 18 ( citing US
Ser. Nos. U.S. Ser. Nos. 12/143,159; 12/143,079).
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Appellants also argue that the claims: (1) recite elements/steps in
addition to the judicial exception(s) that relate to the judicial exception in a
significant way; (2) that the rejection fails to differentiate among the
different limitations in the various claims with respect to the single issue of
patent-eligibility upon which all claims have been rejected. App. Br. 22-25.
We are not persuaded by Appellants' arguments.
Under the analytical framework handed down to us by the Supreme
Court in Mayo Collaborative Serves. v. Prometheus Labs, Inc., 566 U.S. 66
(2012), we initially determine whether the claims at issue are directed to a
patent-ineligible concept. Mayo, 566 U.S. at 78-79. If so, we then consider
the elements of each claim both individually and "as an ordered
combination" to determine whether additional elements "transform the
nature of the claim" into a patent-eligible application. Id.
Appellants' claims are directed to a composition of matter,
specifically, an aqueous extract of "unbroken designed species hybrid com
kernels" having at least 0.5% by weight of anthocyanin content comprising
less than 65% by weight of non-acylated anthocyanin and at least 35% by
weight of acylated anthocyanin, and exhibiting at least 11 chromatographic
peaks representing distinct anthocyanin compounds. See claim 1. We note
that, by the language of the claims, Appellants are not claiming a newly-
generated strain or breed of com kernel, but, rather are claiming a
composition extracted from any strain or breed of com that meets the
compositional limitation recited in the claims, regardless of whether the
designed species hybrid was produced by direct genetic manipulation, cross-
pollination, or other traditional methods of cross-breeding. See Spec. 19-20
("Thus, any methods using the inbred maize line F AR601 or F AR045 are
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contemplated to be within the scope of this invention, e.g., selfing,
backcrossing, hybrid production, crosses to other hybrids, inbreds,
populations, and the like").
Anthocyanins are a class of polyphenol that are produced naturally in
plants, including com. See Spec. 1:
The present invention relates to the field of naturally
occurring colorants and chemicals from plants, including
genetically modified and cross-pollinated plants, the provision of
colorant and chemicals from plants having high levels of
specifically desirable colorants and chemicals, and particularly
to corn species that provide significant levels of anthocyanins in
products from the corn.
(Emphases added); see also id. at 14 ("Pigments found in fruits and
vegetables such as carotenoids, chlorophylls, anthocyanins and
anthoxanthins provide color. These are the natural color pigments that stain
or color the skin when the pigments are applied on the skin") ( emphasis
added); id. at 7 ("Anthocyanin pigments/dyes are extracted from natural,
hybrid or inbred com kernels by adding the appropriate com kernels with
less than 10% and preferably less than 5% by weight comprised of broken
kernels to an aqueous medium to form an aqueous-com medium").
Importantly, Appellants' Specification acknowledges that certain
hybrid varieties of com, particularly those with darker-colored kernels,
naturally produce higher concentrations of acylated anthocyanin:
This process is especially of technical and commercial
importance in the use of dark color com (e.g., the black corns,
reds corns, purple corns) with the anthocyanin levels defined in
the practice of the present invention .... In the process, the
anthocyanin may have greater than 55% by weight of
anthocyanin as an acid or acylated form of the anthocyanin and
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the extract has less than 1.0% solids therein. Where the extract is
a first extract from the kernels, it may contain less than 5% by
weight of the total starch originally in the kernels and greater
than 25% by weight of all anthocyanin originally in the kernels,
as later described in detail.
Spec. 7-8. Appellants' Specification further discloses that certain hybrids can
produce anthocyanins in the proportions prescribed by the claims:
One description of a resulting product from the extraction
process is an anthocyanin-containing extract from com
comprising a composition that when present in water as 1 % to
90% by weight anthocyanin comprises more than 55% by
weight of total anthocyanin as an acid or acylated form of
anthocyanin. This extract may comprise more than 70% by
weight of total anthocyanin as an acid or acylated form of
anthocyanin, and the extract may be free of any acids or bases
that are not extracted or formed from com kernels from which
the extract has been made. The extract may have com used in
the process that comprises tissues ofFAR601, FAR045, hybrids
of F AR601, hybrids of F AR045 or a hybrid of both F AR601 and
FAR045.
Spec. 49.
To summarize, Appellants' Specification discloses that anthocyanins,
including acid or acylated forms are polyphenol molecules that are naturally
produced by com. Furthermore, it was known in the art that certain strains
of com produce higher levels of acid or acylated forms of anthocyanins,
including "F AR601, F AR045, hybrids of F AR601, hybrids of F AR045 or a
hybrid of both F AR601 and F AR045." Spec. 49. Although these may be
higher levels of acid or acylated anthocyanins than are found in other wild-
type or hybrid strains (Appellants' Specification provides no evidence of this
contention) it is not disputed by Appellants that the anthocyanins in the
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aqueous-extraction from com kernels recited in the claims is structurally or
otherwise significantly distinguishable, in either their structure or properties,
than anthocyanins as they occur in situ in these hybrid strains or in other
hybrid or wild-type strains.
Therefore, because we find there is no difference in structure or
properties between the anthocyanins in situ in the com kernel and in the
water extract, we agree with the Examiner that the anthocyanins thus
extracted from com kernels constitute a natural product and are therefore an
unpatentable exception to Section 101. Indeed, Appellants expressly
acknowledge that:
[T]he [ claimed] composition ... is a "natural product" only in the
sense that each individual component may be naturally occurring
... , but that the combination is unique in nature, especially in
conjunction with its being carried in a water composition without
chemical modification or in admixture with ingredients in
addition to the extract.
App. Br. 11-12. That the relative proportion of acid or acylated
anthocyanins to non-acylated anthocyanin is produced only in certain inbred
or hybrid strains is of no import, because the anthocyanins remain the same.
Again, we emphasize that Appellants are not claiming a specific strain of
modified com capable of producing increased levels of anthocyanins, but are
claiming only the extracted anthocyanins from any strain of com capable of
synthesizing such levels. At the very least, in those strains the anthocyanins
produced, and their relative proportions, are produced naturally by the
organism and, in Appellants' composition, are indistinguishable from their
structure and function in situ.
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Nor are we persuaded that Appellants' composition contains any
additional steps that add "significantly more" to Appellants' claimed
composition beyond the natural products themselves. See Mayo, 566 U.S.
at 72-73 (i.e., an "inventive concept" that "amounts to significantly more
than a patent upon the ... [ineligible concept] itself'). Appellants' claimed
composition comprises: "an aqueous composition separated from the
unbroken com kernels." Claim 1. This composition is achieved by soaking
the kernels in water (with or without agitation) at a temperature above 35°C
and then removing the kernels. See Spec. 49-50. This process adds nothing
to the anthocyanins in the com kernels, it merely removes them from inside
the kernel into the aqueous solution.
Nor are we persuaded by Appellants' argument that their composition
is patentably distinct because: "[t]he original anthocyanins as claimed ...
[exist] within cellular structure of ... [the] com kernel cells in admixture with
additional plant content material." See App. Br. 12. Within the cells of the
plant, anthocyanins exist in a solution comprising water, as recited in
Appellants' claims. See Crystal Semiconductor Corp. v. TriTech
Microelectronics Int'!, Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001) (Holding
that use of the transition "comprising" in the language of a claim creates a
presumption that the claim does not exclude additional, unrecited elements).
Appellants point to no limitation of the claim that excludes these other
"additional plant content material," and even if they did, they still fail to
point out how the anthocyanins in their composition are distinguishable from
those in situ within the cells of the plant.
Finally, we find that any additional element of the limitations with
respect to the extract are no more than well-understood, routine, and
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conventional activities in the art. Our reviewing court has recently reminded
us that: "The question of whether a claim element or combination of
elements is well-understood, routine and conventional to a skilled artisan in
the relevant field is a question of fact" and that "[ a ]ny fact, such as this one,
that is pertinent to the invalidity conclusion must be proven by clear and
convincing evidence." Berkheimer v. HP Inc., 881 F.3d 1360, 1368 (Fed.
Cir. 2008). We find that preparing an extract of chemicals from plant
material by heating it in water, with or without agitation, is well-known in
the art and would have been known as a "well-understood, routine and
conventional to a skilled artisan." See, e.g., Taylors of Harrogate Yorkshire
Tea, How to Make a Proper Brew, available at:
https://www.yorkshiretea.co.uk/our-teas/how-to-make-a-proper-brew (last
visited September 18, 2018).
Finally, Appellants argue that the dependent claims are also allowable
because the limitations require: (1) certain concentrations of anthocyanins
( claims 7, 8, 10, 11 ); (2) that the extract be certifiable as organic ( claims 2,
6, and 13-16); that the extracts are produced in a powdery form by drying
the extract ( claims 10 and 11); or ( 4) come from certain specific patented
inbred strains (i.e., FAR045 and FAR601) (claim 22). We agree with the
Examiner, however, that none of the limitations of these claims changes the
essential nature of the anthocyanin or renders it patentably distinct from its
natural form in situ. We consequently affirm the rejection of these claims.
We consequently conclude that Appellants' claims are directed to a
non-statutory category of subject matter, i.e., a product of nature, and that
any additional elements of the claims add nothing more than well-
understood, routine, and conventional activities that do not add significantly
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more than the exception itself. We consequently affirm the Examiner's
rejection of the claims.
DECISION
The Examiner's rejection of claims 1-17 and 20-30 under 35 U.S.C.
§ 101 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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