Ex Parte Burgos et al

Patent Trial and Appeal Board

Dec 29, 2016

13076117 (P.T.A.B. Dec. 29, 2016)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/076,117 03/30/2011 Rafael Burgos Maqui New Life 2972
22925 7590 01/03/2017
PHARMACEUTICAL PATENT ATTORNEYS, LLC
55 MADISON AVENUE
4THFLOOR
MORRISTOWN, NJ 07960-7397
EXAMINER
CLARK, AMY LYNN
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
01/03/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAFAEL BURGOS, JUAN HANCKE, EVELYN JARA, and
MARIA HIDALGO1
Appeal 2015-006760
Application 13/076,117
Technology Center 1600
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
RICHARD J. SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
standardized extract. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
1 According to Appellants, the real party in interest is Maqui New Life S.p.
(Appeal Br. iv.)
Appeal 2015-006760
Application 13/076,117
STATEMENT OF THE CASE
Claims on Appeal
Claims 61, 63, 65—72, 80-86, 88, and 94 are on appeal.2 (Claims
Appendix, Appeal Br. 17—19.) Claim 61 is illustrative and reads as follows:
61. A standardized extract comprising a plurality of anthocyanins and
anthocyanidins, wherein at least about 35% of the composition, by weight, is
a plurality of anthocyanins and anthocyanidins and wherein the anthocyanins
and anthocyanidins are selected from the group consisting of delphinidin-3-
0-sambubioside-5-0-glucoside, delphinidin-3,5-0-diglucoside, cyanidin-3-0-
sambubioside-5-0-glucoside, cyanidin-3,5-0-diglucoside, delphinidin-3-0-
sambubioside, delphinidin-3-0-glucoside, cyanidin-3-0-sambubioside, and
cyanidin-3-0-glucoside; and at least about 15% of the anthocyanins or
anthocyanidins or both, by weight, are sugar-free or sugar-containing
delphinidins, and wherein the composition is nontoxic.
Examiner’s Rejections
1. Claims 61, 63, 65—72, 80-86, 88, and 94 stand rejected under 35
U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA), second paragraph, as
indefinite. (Non-Final 3—4.)
2. Claims 61, 63, 65—72, 80-85, 88, and 94 stand rejected under 35
U.S.C. § 101 as directed to a product of nature. (Ans. 2—9.)3
FINDINGS OF FACT
The following findings are included for emphasis and reference
convenience.
2 Claims 73—79, 89-93, 95, and 96 are withdrawn from consideration. (Non-
Final Office Action dated October 10, 2014 (“Non-Final”), at 1—3.)
3 This is designated as new ground of rejection in the Answer, but the Non-
Final Action also presented a § 101 rejection that Appellants address in the
Appeal Brief.
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FF 1. The Specification states that “[ajnthocyanidins and
anthocyanins (anthocyanidins including sugar groups) are a large family of
naturally occurring pigments. The color of most fruits, flowers and berries is
determined by their content of anthocyanidins and anthocyanins.” (Spec. 1,
11. 16-18.)
FF 2. Appellants state “[ajnthocyanidins such as ‘delphinidin-3-0-
sambubioside-5-0-glucoside’ exist in nature,” and that “there is no structural
difference between delphinidin-3-0-sambubioside-5-0-glucoside in its
naturally occurring state and in the claimed (purified) state.” (Reply Br. 2.)
FF 3. The Examiner finds that the source of the claimed compounds
(,i.e., fruit) is non-toxic. (Ans. 12.)
FF 4. The Specification states that “[t]he compositions . . . can also
include an andrographolide . . . The andrographolide can be an
andrographolide, a deoxyandrographolide, a neoandrographolide, or a
mixture thereof, and it may be contained within an extract of a plant of the
genus Andrographis (e.g., Andrographuspaniculata).” (Spec. 3,11. 9—14.)
FF 5. The Specification states that “the delphinidin-containing (e.g.,
delphinidin-rich) compositions can include specific compounds such as one
or more of: myrtillin, cyanidin, quercetin, a caffeoylquinic derivative, a
proanthocyanidin and/or proanthocyanin (e.g., as found in the herba (e.g.,
leaves) of a plant of the genus Vaccinium).'” (Id. at 2,11. 11—14.)
DISCUSSION
Issue—112
Whether a preponderance of evidence of record supports the
Examiner’s conclusion that claims 61, 63, 65—72, 80-86, 88, and 94 fail to
comply with 35U.S.C. § 112 as indefinite.
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Analysis
The Examiner finds that Appellants’ use of the word “standardized” in
the preamble is indefinite, stating that “[i]n order to be ‘standardized’ there
must be a description of what the extract is standardized against. The
specification, as originally filed, does not define what [Appellants] regard[]
as ‘standardized’ and what the extract(s) is/are standardized against or what
they are in comparison to.” (Non-Final 4.) Appellants argue that the
Examiner requested that Appellants replace the originally filed preamble
term “composition” with “standardized extract,” and that, in any event,
“standardized extract” is merely a preamble that is given no weight. (Appeal
Br. 1—3.) The Examiner does not respond to Appellants’ arguments.
While we take no position on the merits of Appellants’ arguments, the
absence of a response in the Examiner’s Answer calls into question the
continued viability of this rejection. Accordingly, we reverse.
Conclusion
A preponderance of evidence of record fails to support the Examiner’s
conclusion that claims 61, 63, 65—72, 80—86, 88, and 94 fail to comply with
35 U.S.C. § 112 as indefinite.
Issue—101
Whether a preponderance of evidence of record supports the
Examiner’s conclusion that claims 61, 63, 65—72, 80-85, 88, and 94 are
directed to non-statutory subject matter.
Principles of Law
On issues of patent eligibility, we “first determine whether the claims
at issue are directed to a patent-ineligible concept,” such as laws of nature,
natural phenomena, and abstract ideas. Alice Corp. Pty Ltd. v. CLS Bank
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Application 13/076,117
Int'l, 134 S.Ct. 2347, 2355 (2014) (“Alice”). If this threshold is met, we
move to the second step of the inquiry and “consider the elements of each
claim both individually and ‘as an ordered combination’ to determine
whether the additional elements ‘transform the nature of the claim’ into a
patent-eligible application.” Id. (quoting Mayo Collaborative Services v.
Prometheus Laboratories, Inc., 132 S.Ct. 1289, 1297—98 (2012) (“Mayo”)).
Analysis
We adopt the Examiner’s findings and agree with the Examiner’s
conclusion that claims 61, 63, 65—72, 80-85, 88, and 94 are directed to non-
statutory subject matter.4 5(Ans. 2—13.) The rejection is affirmed and
Appellants’ arguments are addressed below.
We address the claims in three groups, with (1) claim 61
representative of claims 61, 63, 72, 80, 82, 88, and 94, (2) claim 65
representative of claims 65—68 and 83—85, and (3) claim 69 representative of
claims 69-71 and 81.
Claim 61
The Examiner finds that the composition of claim 61 is “not markedly
different from [its] closest naturally occurring counterpart because there is
no indication that extraction and partial purification has caused the
anthocyanins and anthocyanidins that comprise the claimed composition^ to
4 The rejection of claim 86 under 35 U.S.C. § 101 is withdrawn (Ans. 9),
and, as set forth above, the rejection of claim 86 under § 112 is reversed.
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have any characteristics that are different from the naturally occurring
anthocyanins and anthocyanidins in maqui fruit.” (Ans. 4.)
Appellants respond by arguing that the Supreme Court decision in
Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct.
2107 (2013) (“Myriad”), supports the patentability of claim 61 because the
claimed extract is “purified.” (Reply Br. 1—3.) Appellants also argue that,
unlike the claims in Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S.
127 (1948) (Funk Bros.), “the instant claims do not preempt the general idea
of combining anthocyanins and anthocyanidins” and “the instant invention
does not have ‘the same effect it always had’ in nature.” (Appeal Br. 12—14,
citing Funk Bros., 333 U.S. at 131.) In particular, Appellants argue that “by
providing these compounds in a concentrated form” the claimed
compositions “acquire a different use” when compared to the amount of
fresh maqui fruit one would otherwise have to consume daily in the absence
of the concentrated form. (Appeal Br. 13—14.)
We find that the Examiner has the better position. Pursuant to the first
step of the Alice patent-eligibility framework, we find that claim 61 is
directed to a patent-ineligible product of nature. (FF 1—3.) See Mayo, 132
S.Ct. at 1293. Claim 61 includes compositions in which naturally-occurring
anthocyanidins and anthocyanins have been combined. Consequently, claim
61 is analogous to the claims in Funk Bros., where the Supreme Court
“considered a composition patent that claimed a mixture of naturally
occurring strains of bacteria” and held that “the composition was not patent
eligible because the patent holder did not alter the bacteria in any way.”
Myriad, 133 S.Ct. at 2117 (discussing Funk Bros.). Here, Appellants
acknowledge the lack of a structural difference between the naturally
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occurring and claimed delphinidin-3-0-sambubioside-5-0-glucoside (FF 2),
and, as in Funk Bros., the claimed invention merely combines naturally
occurring biological compounds and does not change them in any way other
than purification. Moreover, the fact that claim 61 (and other claims) recite
relative amounts (concentrations) of the compounds in the mixture does not
save those claims because several of the claims held patent ineligible in
Funk Bros, also recited relative amounts of the bacterial species in the
mixture. See Funk Bros., 333 U.S. at 128, n.l (e.g., claims 6, 7, and 13.)
In the second step of the Alice framework, we review the claims to
ascertain whether the product of nature has been sufficiently transformed, or
ultimately possess “markedly different characteristics from any found in
nature,” so as to become patent eligible. See Diamond v. Chakrabarty, 447
U.S. 303, 310 (1980). Here, notwithstanding Appellants’ “different use”
argument, there is no evidence of record that the claimed compounds
function differently in the extract of claim 61 than they function, either
independently or in combination, in nature. Like the facts of Funk Bros., the
evidence indicates that the Appellants have done nothing more than bring
together natural compounds in a particular composition. Moreover, contrary
to Appellants’ arguments, Myriad teaches that purification “is not an act of
invention.”5 Myriad, 133 S.Ct. at 2117—18.
5 Appellants’ argument regarding preemption is also unpersuasive because
“the absence of complete preemption does not demonstrate patent
eligibility.” Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371,
1379 (Fed. Cir. 2015).
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Appellants’ claimed extract comprises natural biological compounds,
and the concentration or purification of those compounds does not change
any functional characteristic thereof or create a different use from that found
in nature. Thus, claim 61 fails under the second Alice step.
We affirm the rejection of claim 61 under 35 U.S.C. § 101. Claims
63, 72, 80, 82, 88, and 94 were not argued separately and fall with claim 61.
Claim 65
Claim 65 is dependent on claim 61, and recites “further comprising an
andrographolide, wherein the andrographolide constitutes, by weight, at least
about 10% of the composition.” (Appeal Br. 17.) Moreover, the Examiner
notes that, from Examples 18 and 27 in the Specification, “it appears that the
addition of andrographolide to a composition comprising anthocyanins and
anthocyanidins results in a markedly different characteristic.” (Ans. 6.)
However, the Examiner also notes that the amounts of
anthocyanins/anthocyanidins and andrographolides in the referenced
examples “encompasses only a part of the range of amounts claimed” and
that “[tjhere is no indication that the amounts of andrographolide across the
entire range as claimed imparts those or any other markedly different
characteristics on a composition comprising anthocyanins and
anthocyanidins as claimed.” (Id.) Appellants respond by acknowledging
that “the claimed range is broader than the various ranges used in the
inventors’ Examples,” but that the Examiner has not met the burden of
showing that the claimed range is inoperable. (Reply Br. 3 4.)
We find that the Examiner has the better position, and that claim 65 is
patent-ineligible for the same reasons as set forth above regarding claim 61.
(FF 1 4.) Moreover, the issue is not whether the claimed range is
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inoperable. Rather, the issue is that, while claims limited to compositions
according to Specification Examples 18 and 27, that show a markedly
different characteristic, may be patent eligible, there is no evidence on this
record to indicate that those compositions, and corresponding markedly
different characteristics, would be applicable across the entire range as
claimed. Moreover, because the Examiner established a prima facie case of
unpatentability under § 101, the burden of coming forward with evidence or
argument shifted to Appellants. See In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992).
We affirm the rejection of claim 65 under 35 U.S.C. § 101. Claims
66—68 and 83—85 were not argued separately and fall with claim 65.
Claim 69
Claim 69 is dependent on claim 61, and recites “further comprising a
composition that comprises at least one compound selected among myrtillin,
quercetin, cyanidin, caffeoylquinic derivatives, and proanthocyanidins.”
(Appeal Br. 17.) The Examiner states that “there is no indication that the
amounts of the additional compound claimed in the compositions results in a
markedly different characteristic for the composition as compared to the
anthocyanins and anthocyanidins in maqui fruit which lack that additional
compound.” (Ans. 7.) The Examiner does note that, from Example 27 in
the Specification, “it appears that the addition of an extract of Vaccinium
(which comprises at least some of myrtillin, quercetin, [cyanidin],
caffeoylquinic derivatives and proanthocyanidins) to a composition
comprising anthocyanins and anthocyanidins results in a markedly different
characteristic” but that “there is no indication that any one of myrtillin,
quercetin, [cyanidin], caffeoylquinic derivatives and proanthocyanidins in
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the unspecified amounts or particular ratios as claimed resulted in a
markedly different characteristic when present in the claimed compositions
also comprising anthocyanins and anthocyanidins.” (Id. at 7—8.) Appellants
respond by arguing that the Examiner has not met the burden of showing
that the claimed range is inoperable. (Reply Br. 4.)
We find that the Examiner has the better position, and that claim 69 is
patent-ineligible for the same reasons as set forth above regarding claim 61.
(FF 1—5.) Again, the issue is not whether the claimed range is inoperable.
Rather, while the Examiner acknowledges a markedly different
characteristic with respect to Example 27, we agree with the Examiner that
“there is no indication that any one of [the compounds recited in claim 69] in
the unspecified amounts or particular ratios as claimed resulted in a
markedly different characteristic when present in the claimed compositions
also comprising anthocyanins and anthocyanidins.” (Ans. 8.) See In re
Oetiker, 977 F.2d at 1445.
We affirm the rejection of claim 69 under 35 U.S.C. § 101. Claims
70, 71, and 81 were not argued separately and fall with claim 69.
Conclusion
A preponderance of evidence of record supports the Examiner’s
conclusion that claims 61, 63, 65—72, 80—85, 88, and 94 are directed to non-
statutory subject matter.
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SUMMARY
We reverse the rejection of claims 61, 63, 65—72, 80—86, 88, and 94
for failure to comply with 35 U.S.C. § 112 as indefinite.
We affirm the rejection of claims 61, 63, 65—72, 80-85, 88, and 94
under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
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