Ex Parte Han et al

Patent Trial and Appeal Board

Nov 30, 2017

11913729 (P.T.A.B. Nov. 30, 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.
11/913,729 11/04/2008 Qiang Han 102745.000420 8346
23377 7590 12/04/2017
R AKFR fr TTOSTRTT FR T T P
EXAMINER
CIRA CENTRE 12TH FLOOR SZNAIDMAN, MARCOS L
2929 ARCH STREET
PHILADELPHIA, PA 19104-2891 ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
12/04/2017 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):
eofficemonitor@bakerlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte QIANG HAN, AMOS B. SMITH III, GARY K. BEAUCHAMP,
PAUL A.S. BRESLIN, RUSSELL S.J. KEAST, and JIANMING LIN
Appeal 2017-002362
Application 11/913,7291
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
DAVID COTTA, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 8-11 and 82-87
(App. Br. I).2 Examiner entered a rejection under 35 U.S.C. § 103(a). We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as “Monell Chemical Senses
Center and The Trustees of The University of Pennsylvania” (App. Br. 1).
2 Claims 55-58, 60, 71-74, and 76-81 stand withdrawn from consideration
(Examiner’s December 17, 2015 Final Office Action (“Final Act.”) 2).
Appeal 2017-002362
Application 11/913,729
STATEMENT OF THE CASE
Appellants’ disclosure “relates to the active principal in olive oil,
termed oleocanthal, and methods of using oleocanthals in various
formulations including, food additives, pharmaceuticals, cosmetics, animal
repellants, and discovery tools for mammalian irritation receptor genes, gene
products, alleles, splice variants, alternate transcripts and the like” (Spec.
^ 2). Claim 8 is representative and reproduced below:
8. A pharmaceutical composition consisting of a
therapeutically effective amount of a compound having the
formula:
wherein:
Ri and R4 are independently H or OR5
R2 and R3 are independently CHO, or COORs
Rs is a H, C1-C5 alkyl, or a glycoside
X is O, NH or CH2
Y is C=CHCH3, or CH-COORs
Z is C=0 or CH-ORs
A is CH2, or CH-COORs;
and a pharmaceutically acceptable carrier;
wherein the pharmaceutical composition comprises 1-10% by
weight of the compound and wherein the composition is in the
form of tablets, pills, powders, lozenges, sachets, suspensions,
emulsions, syrups, aerosols, ointments, soft and hard gelatin
capsules, suppositories, sterile injectable solutions, or sterile
packaged powders.
(App. Br. 10.)
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Application 11/913,729
The claims stand rejected as follows:
Claims 8-11 and 82-87 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Owen,3 Andrewes,4 and
Papathanassiu.5
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Andrewes discloses that the term “[pjolyphenols is a broad term used
in the natural products literature to define substances that possess a benzene
ring bearing one or more hydroxy groups, including functional derivatives,”
that “[pjolyphenols have very similar chemical structures,” and that “[tjhese
compounds are responsible for the oxidative stability of virgin olive oils . . .
and are associated with health benefits” (Andrewes 1415 (left column, first
and second paragraphs) (endnotes omitted)).
FF 2. Andrewes discloses the isolation, from olive oil, of deacetoxy-
ligstroside aglycon (i.e. oleocanthal), having the following formula:
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3 R.W. Owen et al., The antioxidant/anticancer potential of phenolic
compounds isolated from olive oil, 36 European Journal of Cancer
1235^17 (2000).
4 Paul Andrewes et al., Sensory Properties of Virgin Olive Oil Polyphenols:
Identification of Deacetoxy-ligstroside Aglycon as a Key Contributor to
Pungency, 51 J. Agric. Food Chem. 1415-20 (2003).
5 Papathanassiu, US 6,528,489 Bl, issued Mar. 4, 2003.
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Application 11/913,729
(Andrewes 1417: Fig. 1; Ans. 3 (“Andrewes teaches the isolation and
purification of oleocanthal (see structure on Figure 1 on page 1417) from
olive oil extracts by using liquid/liquid extraction and reverse phase HPLC
(see entire document)”).)
FF 3. Andrewes discloses that “deacetoxy-ligstroside aglycon[,
oleocanthal,] is the polyphenol responsible for the majority of the burning
pungent sensation found in pungent extra virgin olive oils” (Andrewes,
Abstract).
FF 4. Owen discloses “[t]he antioxidant/anticancer potential of phenolic
compounds isolated from olive oil” (Owen, Title).
FF 5. Owen discloses the “[structures of the phenolic compounds and
their precursors detected in olive oil,” including oleocanthal, having the
structure reproduced above, and oleuropein glucoside, which has the
following structure:
(Owen 1240: Fig. 8 (compound II); see generally Ans. 3.)
FF 6. Examiner finds that although Owen did not test the antioxidant
activity of oleocanthal, Owen found that the closely related polyphenol,
oleuropein glucoside, exhibits “high antioxidant activity” (Ans. 3; see FF 1).
FF 7. Owen discloses that “[t]he dual action of the major phenolics[, such
as oleocanthal,] present in olive oil is of importance, in that not only will
high dietary intakes increase defence in scavenging reactive oxygen species,
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Application 11/913,729
but also, will suppress xanthine oxidase activity, a factor which is known to
influence carcinogenesis” (Owen 1246 (first full paragraph); see Ans. 3).
FF 8. Examiner finds that the combination of Owen and Andrewes fails to
disclose “a pharmaceutical composition of oleocanthal in the form of a
tablet, pill, powder, etc.,” wherein the pharmaceutical composition
comprises 1-10% by weight of oleocanthal and relies on Papathanassiu to
disclose the formulation of biologically active compounds as, inter alia,
“capsules, cachets or tablets” (Ans. 4 (citing Papathanassiu 5:2^12)).
ANALYSIS
As Appellants explain, due to a Restriction Requirement, “this appeal
focuses on the patentability of claims 9-11 and 83-85, and claims 8, 82, 86,
and 87, insofar as they relate to the elected species[:] ‘Oleocanthal,’” having
the following formula:
App. Br. 4-5. We limit our deliberations to Appellants’ elected invention
and take no position respecting the patentability of the non-elected species.
See Ex parte Ohsaka, 2 USPQ2d 1460 (BPAI 1987).
Based on the combination of Owen, Andrewes, and Papathanassiu,
Examiner concludes that, at the time Appellants’ invention was made, it
would have been prima facie obvious to formulate a pharmaceutical
composition consisting of oleocanthal as a capsule, cachet, or tablet, wherein
the pharmaceutical composition comprises 1-10 % oleocanthal (see Ans. 4-
5). In this regard, Examiner reasons that, although the combination of
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Application 11/913,729
Owen, Andrewes, and Papathanassiu does not disclose a pharmaceutical
composition comprising 1-10% oleocanthal, it would have been prima facie
obvious to determine the appropriate concentration of oleocanthal through
routine optimization (see Ans. 5). See In re Geisler, 116 F.3d 1465, 1470
(Fed. Cir. 1997) (“‘[I]t is not inventive to discover the optimum or workable
ranges by routine experimentation.’”) (quoting In reAller, 220 F.2d 454,
456 (CCPA 1955)).
Andrewes isolated polyphenols, including oleocanthal, and the
combination of Andrewes and Owen identifies polyphenols as having, inter
alia, antioxidant properties (FF 1, 2, and 4-7). Therefore, we are not
persuaded by Appellants’ contention that “prior to [Appellants’] invention,
oleocanthal had not been isolated or tested for any pharmacological activity
and it had not been identified as having any therapeutic use” (App. Br. 5; see
also id. at 7-8 (discussing “lead compounds”). To be clear, notwithstanding
Appellants’ contentions regarding “lead compounds,” Examiner’s rejection
is not based upon a modification of oleuropein glucoside, to obtain
oleocanthal, which was isolated by Andrewes and disclosed by Owen, but is
instead based on the recognition that oleocanthal, and polyphenols in
general, are, inter alia, antioxidants.
Appellants’ claimed invention is not limited to an oleocanthal that
exhibits anti-inflammatory activity as a COX-1 and COX-2 inhibitor, with
no effect on lipoxygenase activity. Therefore, we are not persuaded by
Appellants’ contentions regarding this activity of oleocanthal (see App. Br.
5). The combination of Owen, Andrewes, and Papathanassiu suggests that
oleocanthal has, inter alia, antioxidant activity (see FF 1,2, and 4-8).
Therefore, we find no error in Examiner’s conclusion that a person of
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ordinary skill in this art would have formulated oleocanthal, in the form of a
capsule, cachet, or tablet, to benefit from its antioxidant properties (see Ans.
4; FF 1, 2, and 4-8). See KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 419
(2007) (“In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed purpose of the
patentee controls. What matters is the objective reach of the claim. If the
claim extends to what is obvious, it is invalid under § 103.”); see also In re
Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992) (“[T]he law does not require
that the references be combined for the reasons contemplated by the
inventor”); Catalina Mktg. Inti, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,
809 (Fed. Cir. 2002) (“[T]he patentability of. . . composition claims depends
on the claimed structure, not on the use or purpose of that structure”).
We recognize that Andrewes discloses that oleocanthal is “responsible
for the majority of the burning pungent sensation found in pungent extra
virgin olive oils” (FF 3). For the foregoing reasons, however, we are not
persuaded by Appellants’ contention that the combination of Owen,
Andrewes, and Papathanassiu fails to suggest “that oleocanthal is anything
other than an irritant” or motivate “anyone of ordinary skill in the art to
package oleocanthal in any of the claimed pharmaceutical composition . . .
forms” (App. Br. 5; see also Reply Br. 2).
As discussed above, the combination of Owen, Andrewes, and
Papathanassiu suggests that: the polyphenol, oleocanthal, is, inter alia, an
antioxidant, polyphenols are antioxidants, “[pjolyphenols have very similar
chemical structures,” and oleuropein glucoside, which has a very similar
chemical structure to oleocanthal, is an antioxidant (FF 1, 2, and 4-7).
Therefore, we are not persuaded by Appellants’ contentions regarding
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Application 11/913,729
Examiner’s reasoning relating to oleuropein glucoside. To the contrary,
Owen’s disclosure relating to oleuropein glucoside supports the disclosure in
Andrewes and Owens that oleocanthal is an antioxidant, as are polyphenols
in general (see App. Br. 6-7; Reply Br. 3—4; cf FF 1, 2, and 4-7).
We recognize that Owen discloses that “extracts of olive oil
containing a mixture of known and unknown phenolics, were effective [as
antioxidants] at far lower concentrations than the compounds tested
individually” (see Owens 1245 (right column, second full paragraph)). We
are not persuaded, however, that this disclosure in Owens “instructs that
none of the compounds highlighted by the Examiner would have been
predictably effective as single agents” (see App. Br. 8-9). For the foregoing
reasons, we are not persuaded by Appellants’ contention that “the skilled
person could not have predicted that oleocanthal, as a sole therapeutic agent,
would have had any pharmacological utility” (id. at 8).
CONCFUSION OF FAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 8 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Owen, Andrewes, and
Papathanassiu is affirmed. Claims 9-11 and 82-87 are not separately argued
and fall with claim 8.
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
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