Ex Parte Di Pierro

Patent Trial and Appeal Board

Mar 13, 2017

13387474 (P.T.A.B. Mar. 13, 2017)

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.
13/387,474 03/09/2012 Franceso Di Pierro SS122-1054 7061
122515 7590 03/15/2017
Silvia Salvadori, P.C.
Silvia Salvadori
270 Madison Avenue, 8th Floor
New York, NY 10016
EXAMINER
TATE, CHRISTOPHER ROBIN
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
03/15/2017 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
following e-mail address(es):
silvia@salvadorilaw.com
silvia30121 @ me. com
eofficeaction @ appcoll.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FRANCESCO Di PIERRO1
Appeal 2015-007162
Application 13/387,474
Technology Center 1600
Before DONALD E. ADAMS, JOHN G. NEW, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellant states the real party-in-interest is Velleja Research S.r.l of Milan,
Italy. App. Br. 3.
Appeal 2015-007162
Application 13/387,474
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Non-Final Rejection of claims 12—20. Specifically, claims 12—
20 stand rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious
over the combination of O’Reilly (US 6,242,030 Bl, June 5, 2001)
(“O’Reilly”), S. Bastianetto et al., The Ginkgo biloba Extract (EGb 761)
Protects and Rescues Hippocampal Cells Against Nitric Oxide-Induced
Toxicity: Involvement of its Flavonoid Constituents and Protein Kinase C,
74 J. Neurochem. 2268—77 (2000) (“Bastianetto I”), S. Bastianetto and R.
Quirion, EGb 761 is a Neuroprotective Agent Against f-Amyloid Toxicity,
48(6) Cell. Mol. Biol. 693—97 (2002) (“Bastianetto II”) and the
Appellant’s Admitted Prior Art (“AAPA”).
Claim 14 stands rejected as unpatentable under 35 U.S.C. § 103(a) as
being obvious over the combination of O’Reilly, Bastianetto I, Bastianetto
II, the AAPA, and Nissen et al. (US 2006/0147580 Al, publ. July 6, 2006)
(“Nissen”).
Claims 12—20 also stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Kurppa (WO 01/49285
Al, July 12, 2001) (“Kurppa”), Yamada et al. (JP 2005-104850, April 21,
2005) (“Yamada”), and the AAPA.
Claims 14 also stands rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of over Kurppa, Yamada,
the AAPA, and Teng (US 2004/0109907 Al, publ. June 10, 2004).
We have jurisdiction under 35 U.S.C. § 6(b)
We AFFIRM.
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Application 13/387,474
NATURE OF THE CLAIMED INVENTION
Appellant’s invention is directed to a Ginkgo biloba extract
substantially devoid of PAF (Platelet-Activating Factor)-antagonist activity.
Abstract.
REPRESENTATIVE CLAIM
Claim 15 is the sole independent claim on appeal and representative
of the remaining claims. Claim 15 recites:
15. Method of treating vasculokinetic, geriatric, anti­
dementia, cognitive or sensory deficit comprising administering
to a subject in need thereof an effective amount of a [G]inkgo
biloba extract having a terpene content lower than 0.1 %,
wherein said [G]inkgo biloba extract does not cause any increase
in bleeding time caused by a platelet anticlotting agent when said
[G]inkgo biloba extract is administered together with said
platelet anti-blood clotting agent.
App. Br. 16.
ISSUES AND ANALYSIS
We agree with, and adopt, the Examiner’s reasoning and conclusion
that the claims on appeal are prima facie obvious over the combined cited
prior art. We address the arguments presented by Appellant below.
A. Rejection of claims 12—20 over O’Reilly, Bastianetto I, Bastianetto II
and the AAPA
Issue
Appellant argues the Examiner erred in finding the combined cited
prior art references teaches or suggests the limitation of claim 15 reciting:
“[A]n effective amount of a [G]inkgo biloba extract having a terpene content
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lower than 0.1 %, wherein said [G]inkgo biloba extract does not cause any
increase in bleeding time caused by a platelet anticlotting agent when said
[G]inkgo biloba extract is administered together with said platelet anti-blood
clotting agent.” App. Br. 7.
Analysis
Appellant argues O’Reilly provides only for a flavonoid extract of
Ginkgo biloba, with a maximum terpene content of 0.5%. App. Br. 7 (citing
O’Reilly col. 1,11. 36—37). Appellant contends O’Reilly is silent with regard
to the method recited in claim 15. Id.
Appellant also asserts that Bastianetto I does not cure the alleged
deficiencies of O’Reilly. App. Br. 7. Specifically, Appellant argues,
Bastianetto I describes only three different types of Ginkgo biloba extracts,
characterized by differing amounts of terpenes, and their activity in
protecting and rescuing hippocampal cells against nitric oxide-induced
toxicity. Id. (citing Bastianetto I Abstr.). According to Appellant,
Bastianetto I teaches a preferred compound, EGb 761, which contains 6%
terpenoids. Id. (citing Bastianetto I 2268). Appellant argues that Bastianetto
I’s compound CP 205 is an extract of EGb 761’s flavonoid fraction. Id.
Appellant contends Bastianetto I teaches a neuroprotective effect of its
preferred compounds, but is silent with regard to a method of treating
vasculokinesis, etc., by administering an effective amount of a Ginkgo
biloba extract with a terpene content lower than 0.1 % wherein, when
administered to a subject treated simultaneously with a platelet anticlotting
agent. Id.
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Appellant argues further that Bastianetto II reprises the teachings of
Bastianetto I, describing the same extracts (EGb 761 and CP 205) and their
activity against P-amyloid toxicity. App. Br. 8 (citing Bastianetto II Abstr.).
Appellant disputes the Examiner’s conclusion that the claims are
obvious over the combined cited prior art references in view of Appellant’s
admission that it was a common practice in treating geriatric subjects to
chronically administer anti-aggregants and/or anticoagulants to reduce
potential cardiovascular events. App. Br. 8. Appellant alleges the Examiner
is impermissibly picking and choosing disclosures from Appellant’s
Specification and combining them with the cited references. Id.
Appellant next argues that the Specification teaches away from the
cited reference’s extracts having a high terpenic amount because they
contribute to an undesirable PAP-antagonist action. Ans. 9. Appellant
asserts the Specification discloses that the majority of the extracts currently
available contain a terpenic fraction in substantial quantities (up to 6% of the
extract). Id. at 8. Appellant assert that, to the extent that this fraction is
believed to contribute to the known activities of Ginkgo extracts, and also
possesses PAP-antagonist activity. Id. at 8 (citing Spec. 3). Appellant
argues further that their Specification discloses that when a Ginkgo biloba
extract with a terpenic amount of 6% is administered in combination with an
anti-blood clotting drug, the bleeding time can increase by up to 150%. Id.
at 10.
Finally, Appellant argues that a person of ordinary skill in the art
would not have been motivated to combine the references cited by the
Examiner because the references teach Ginkgo biloba extracts characterized
by substantially different amounts of terpenic fraction. App. Br. 9—10.
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The Examiner responds that the limitation of claim 15 reciting:
“wherein said [G]inkgo biloba extract does not cause any increase in
bleeding time caused by a platelet anticlotting agent when said [G]inkgo
biloba extract is administered together with said platelet anti-blood clotting
agents” would be inherent in the terpene-free Ginkgo biloba extract taught
by O’Reilly, as well as the terpene-free flavonoid Ginko extract fraction, CP
205, taught by Bastianetto I and Bastianetto II. Ans. 11.
The Examiner finds the Ginkgo biloba extract taught by O'Reilly is
expressly taught as being terpene-free. Ans. 12 (citing O’Reilly, e.g., Title,
Abstr.). The Examiner finds the complete passage in O’Reilly concerning
the terpene content of their Ginkgo biloba extracts teaches that one of the
aspects of their invention has as its object, a flavonoid-rich Ginkgo biloba
extract which contains no, or only a small quantity of, terpenes, and which
has a high degree of therapeutic activity. Id. (citing O’Reilly col. 1,11. 25—
38). The Examiner finds O’Reilly further teaches a flavonoid extract of
Ginkgo biloba that is free of terpenes; however, if the extract contains any
terpenes, that terpene content is preferably a maximum of 0.5%. Id. (citing
O’Reilly col. 1,11. 25—38). The Examiner therefore finds O’Reilly teaches a
preferred embodiment of their invention is a terpene-free Ginkgo biloba
flavonoid extract that is therapeutically active. Id.
The Examiner finds CP 205, the flavonoid-rich, terpene-free Ginkgo
biloba extract taught by both Bastianetto I and II references, teaches
administering to a subject a Ginkgo biloba extract with a terpene content
lower than 0.1 %. Ans. 13. Furthermore, the Examiner finds, the claim
limitation “wherein said ginkgo biloba extract does not cause any increase in
bleeding time caused by a platelet anti-clotting agent when said ginkgo
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biloba extract is administered together with said platelet anti-blood clotting
agent,” reads upon administering a terpene-free extract to a geriatric subject
who is also taking an anti-clotting agent. Id. Such administration, the
Examiner finds, is admitted by Appellant to be a common practice in
treating geriatric subjects (such as those having neuronal degeneration)-the
chronic administration of anti-aggregants and/or anticoagulants reduces the
risk of cardiovascular events (such as thrombosis, heart attack, and stroke) or
to inhibit tumor metastasis. Id. (citing Spec. 3—4). The Examiner therefore
concludes it would have been obvious to a person of ordinary skill in the art
to treat a subject suffering from Alzheimer’s disease the therapeutically-
active terpene-free Gingko biloba extract taught by O'Reilly. Id. at 13—14.
We are not persuaded by Appellant’s arguments. As an initial matter,
Appellant suggests that the claimed invention has surprising or unexpected
properties with respect to possessing no anti-platelet aggregation action.
App. Br. 6—7. Appellant’s Specification relates anecdotal disclosures of
studies allegedly disclosing that Gingko biloba extracts with substantial
concentrations of terpenes (up to 6%), when co-administered with certain
anticoagulants, causes an increased risk of spontaneous bleeding in elderly
patients. See Spec. 3^4. However, Appellant’s Specification provides no
source citations for these studies. Nor does Appellant adduces any evidence
in the prior art that administration of terpene-free extracts of Gingko biloba,
or flavonoid fractions thereof, would similarly be expected to provide a
greater risk of hemorrhage. As such, their argument that the properties of
the compound are surprising or unexpected are not persuasive. See In re
Baxter TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[Wjhen
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unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art”).
Moreover, Appellant argues that O’Reilly does not teach a terpene-
ffee Gingko biloba extract, or one with a terpene content of less than 0.1%,
as recited in claim 15. However, we agree with the Examiner that O’Reilly
explicitly teaches: “One of the aspects of the present invention therefore has
as its object extracts which do not comprise any or only a small quantity of
terpenes (ginkgolides and bilobalides) which have a high degree of
therapeutic activity” and that:
The invention also has as its object a flavonoid extract of
Ginkgo biloba leaves free of terpenes. This means that the
extract comprises flavonoid heterosides and small quantities of
terpenes or no terpenes. If the extract comprises terpenes, the
terpene content is a maximum of 1 %, preferably a maximum of
0.5%.
O’Reilly col. 1,11. 25—28; 33—38 (emphases added). We agree with the
Examiner that a person of ordinary skill in the art would understand that
claim 15’s recitation of an “amount of a [G]inkgo biloba extract having a
terpene content lower than 0.1 %” would fall within the scope of O’Reilly’s
teaching of an extract of Gingko biloba with a terpene content of between
0% (i.e., “free of terpenes”) and 0.5%.
Furthermore, we agree with the Examiner that the Bastianetto
references teach that the administration of Gingko biloba to patients
suffering from dementia was well-known in the art. For example,
Bastianetto I teaches: “Clinical trials support the potential therapeutic
usefulness of [Gingko biloba extract] EGb 761 in the treatment of cerebral
insufficiency ... and mild cognitive impairments in elderly patients ..., as
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well as in Alzheimer’s disease and vascular dementia....” Bastianetto I
2269.
Bastianetto I and II also teach that the flavonoid extract of EGb 761,
CP 205, which, as taught by O’Reilly, may be terpene-free, has a similar
activity to that exhibited by EGb 761, whereas the terpenoid fraction did not:
“Similar, but slightly less potent, inhibitory effects were observed when the
cells were co-treated with the flavonoid fraction CP 205 (25 jig/ml; Fig. 6A).
In contrast, the terpenoids bilobalide (CP 160, 1 pg/ml) and ginkgolide (BN
52021, 1 gg/ml) did not decrease SNP-induced reactive oxygen species
accumulation....” Bastianetto I 2272.
We agree with Appellant that the combined references neither teach
nor suggest the limitation of claim 15 reciting “wherein said [G]inkgo biloba
extract does not cause any increase in bleeding time caused by a platelet
anticlotting agent when said [G]inkgo biloba extract is administered together
with said platelet anti-blood clotting agent.” However, this unknown
property of a known compound, which is administered for a purpose recited
in the claim and well-known in the art (i.e., anti-dementia, cognitive or
sensory deficit treatment), is insufficient to render the unknown property
patentably distinct. See, e.g., In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir.
1990) (“It is a general rule that merely discovering and claiming a new
benefit of an old process cannot render the process again patentable”).
Furthermore, we agree with the Examiner that administering a
terpene-free extract to a geriatric subject who is also taking an anti-clotting
agent which, as readily admitted by Appellant, is a common practice in
treating geriatric subjects (such as those having neuronal degeneration), to
reduce their cardiovascular events (such as thrombosis, heart attack, and
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stroke) or to inhibit tumor metastasis, would be obvious to a person of
ordinary skill in the art, based upon the teachings of Bastianetto I and II. See
Ans. 13 (citing Spec. 3—4). We consequently agree with the Examiner’s
conclusion that the claims are prima facie obvious over the combined cited
prior art, and we affirm the Examiner’s rejection on this ground.
B. Rejection of claims 12—20 over Kurppa, Yamada, and the AAPA
Issue
Appellant argues the Examiner erred in finding that the cited prior art
references teach or suggest all of the limitations of claim 15. App. Br. 13.
Analysis
Appellant argues invention. Kurppa teaches only flavonoids extracts
selected from flavonoids of onion, green and black tea, apple, grape, bark of
Ginkgo biloba and Maritime pine. App. Br. 13 (citing Kurppa 5). Appellant
contends Kurppa is silent with respect to the claimed method of using a
Ginkgo biloba extract having a terpene content lower than 0.1%. Id.
Appellant argues Yamada teaches the therapeutic and prophylactic
activity of polyphenols useful in Alzheimer's disease but is also silent with
respect to the method recited in claim 15. App. Br. 13.
Appellant argues Kurppa does not provide any teaching or motivation
to one skilled in the art for selecting flavonoids from Ginkgo biloba over
flavonoids extracted from onions or apples, etc. App. Br. 14. Appellant also
argues that a person of ordinary skill in the art would not have appreciated
from the teachings of Kurppa, the necessity of low concentrations of
terpenes in the flavonoids selected. Id.
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Nor, Appellant argues, do the teachings of Yamada cure the alleged
deficiencies of Kurppa. App. Br. 14. Rather, Appellant asserts, Yamada
teaches only that polyphenols can play an active role in suppressing the
production or deposition of the amyloid fibers in cerebral tissues. Id.
Appellant contends Yamada is silent with respect to extracts of Ginkgo
Biloba a concentration of terpenes less than 0.1%. Id.
Therefore, Appellant argues, a person of ordinary skill in the art
would not have been motivated to choose an extract of Ginkgo biloba from
those taught by Kurppa for combination with the teachings of Yamada, nor
would that person of ordinary skill arrive at Appellant’s claimed invention.
App. Br. 14.
The Examiner responds that Kurppa teaches beneficial flavonoid
compounds extractable from Gingko biloba, including preferred compounds
quercetin and myricetin, useful in the treatment of various diseases and
disorders related to aging, including cardiovascular diseases and elevated
blood pressure (i.e., vasculokinetic conditions). Non-Final Act. 7. The
Examiner finds Kurppa further discloses that combining such flavonoids as
quercetin with one or more other flavonoids such as myricetin provides an
enhanced (i.e., complimentary or synergistic) effect. Id. (citing Kurppa 1—7,
9—12, claims).
The Examiner finds Yamada teaches polyphenol (i.e., flavonoid)
compounds from red wine, such as quercetin and myricetin, are well known
to be extractable from Ginkgo biloba. Non-Final Act. 7—8. The Examiner
finds Yamada teaches these flavonoids are useful for treating Alzheimer’s
disease via administering an oral composition containing one of more of the
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individual flavonoids (especially those containing high concentrations of
quercetin and myricetin). Id. at 8.
The Examiner concludes that it would have been obvious to one of
ordinary skill in the art to treat a geriatric subject suffering a disease or
disorder related to aging, such as vasculokinetic conditions and/or
Alzheimer’s disease by administering to the subject a composition
comprising one or more flavonoids extractable from Gingko biloba, such as
quercetin and myricetin. Non-Final Act. 8. The Examiner also finds that the
flavonoid-containing compositions taught by Kurppa and Yamada would
inherently be devoid of PAP-antagonist activity, since each are terpene-ffee.
We are not persuaded by Appellant’s arguments. Both Kurppa and
Yamada teach the use of specific flavonoids extracted from, inter alia,
Gingko biloba for the treatment of “vasculokinetic, geriatric, anti-dementia,
cognitive or sensory deficits],” as recited in claim 15. For example, Kurppa
is directed to: “a mixture of at least two, and preferably three flavonoids in
an orally, parenterally or topically administrable dosage form,” and that:
The preferred flavonoids are selected from flavonoids of onion,
green and black tea, apple, grape, bark of Ginko [bjiloba and
Maritime pine. Especially preferred are quercetin and its
derivatives, epigallocatechin and its derivatives, especially
epigallocatechin-3-gallate, and myricetin. The preferred
flavonoid is epigallocatchin gallate. It is most preferably used in
combination with quercetin and vitamin C, possibly also vitamin
E. Vitamin C is believed to prevent oxidation of polyphenols and
to reactivate vitamin E.
Kurppa 3,5. Similarly, Yamada teaches the use of the same or similar
flavonoids (i.e., polyphenols) for the treatment of Alzheimer’s disease.
Moreover, we find that use of the isolated flavonoids in medical
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compositions necessarily teach an extract that is free of terpenes. See, e.g.,
Kurppa, Table II. We agree with the Examiner that the references thus teach
“administering to a subject in need thereof an effective amount of a [G]inkgo
biloba extract having a terpene content lower than 0.1 %,” as recited in
claim 15.
We do not agree with Appellant’s contention that a person of ordinary
skill would not have been motivated to choose an extract of Ginkgo biloba
from those of “the list” taught by Kurppa (see App. Br. 14); on the contrary,
we read the teachings of Kurppa quoted above as meaning that the
flavonoids in question may be isolated from any of the plants recited. See
Kurppa 5. Furthermore, as we explained above, an unknown property (i.e.,
no increase in bleeding time when co-administered platelet anti-blood
clotting agent) of the known compound, which is administered for a purpose
recited in the claim and well-known in the art (i.e., anti-dementia, cognitive
or sensory deficit treatment), is insufficient to render the unknown property
patentably distinct. See Woodruff, 919 F.2d at 1578. We consequently
affirm the Examiner’s rejection of the claims.
DECISION
The Examiner’s rejection of claims 12—20 as unpatentable under 35
U.S.C. § 103(a) 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)(1). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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