Ex Parte Wirth et al

Patent Trial and Appeal Board

Oct 28, 2016

12107526 (P.T.A.B. Oct. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/107,526 04/22/2008
23599 7590 11/01/2016
MILLEN, WHITE, ZELANO & BRANIGAN, P,C
2200 CLARENDON BL VD.
SUITE 1400
ARLINGTON, VA 22201
Corinna Wirth
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.
MERCK-2734-COl 9889
EXAMINER
BERRIOS, JENNIFER A
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
11/01/2016 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):
docketing@mwzb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CORINNA WIRTH,
HERWIG BUCHHOLZ, and CHRISTOPHE CAROLA
Appeal2014-004433
Application 12/107,526
Technology Center 1600
Before JEFFREYN. FREDMAN, RICHARD J. SMITH, and
DAVID COTTA, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
r-T"I .. • • .. 1 .. ,..... ,_ TT r'1 I'\ l\ -1,..... Al • "1 • "1 • , ,.. .. ims 1s an appear unaer j) u.~.L. s U4 mvo1vmg crnm1s to a memoa
of treating inflammation or filtering UV radiation. The Examiner rejected
the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.
Statement of the Case
Background
"The object of care cosmetics is wherever possible to obtain the
impression of youthful skin ... For example, existing skin damage, such as
1 Appellants identify the Real Party in Interest as Merck Patent
GMBH (see App. Br. 1 ).
Appeal2014-004433
Application 12/107,526
irregular pigmentation or the development of wrinkles, can be compensated
for by covering powders or creams" (Spec. 2:6-11). "Another approach is
to protect the skin against environmental influences which lead to permanent
damage and thus ageing of the skin. The idea is therefore to intervene in a
preventative manner and thus to delay the ageing process" (Spec. 2:11-15).
The Claims
Claims 16-23 and 29-35 are on appeal. Claim 29 is representative
and reads as follows:
29. A method of topically treating inflammation or filtering
UV radiation comprising topically administering to a person in
need thereof a cosmetic formulation comprising a compound of
the formula IA
in which
R1, R2 and R3 are each, independently of one another, OH,
CH3COO, an alkoxy radical having from 1 to 8 carbon atoms or
a monoglycoside radical,
R 4 is a mono- or diglycoside radical, wherein
is bonded to the glycoside radical via an -0- group,
and R8 is OR, CH3COO, an alkoxy radical having from 1
to 8 carbon atoms or a monoglycoside radical,
2
Appeal2014-004433
Application 12/107,526
and
in which one or more hydrogen atoms in the OH groups of the
glycoside radical(s) may each, independently of one another,
also be replaced by acetyl or by alkyl radicals having from 1 to
8 carbon atoms, and where, in each case independently of one
another, sulfate or phosphate may also be bonded to one or
more hydroxyl groups of the compounds of the formula IA,
wherein the compound of the formula IA is prepared
synthetically or is in the form of a plant extract, a purified plant
extract or in the form of the pure substance prepared from the
plant extract,
and a cosmetically acceptable carrier for topical
application to treat inflammation topically.
The issue
The Examiner rejected claims 16-23 and 29-35 under 35 U.S.C.
§ 103(a) as obvious over Lanzendorfer,2 Tsuruga,3 Pearce,4 and Menendez5
(Ans. 3-5).
The Examiner finds that "Lanzendorfer teaches cosmetic and
dermatological formulations having flavonoids . ... Suitable flavonoids are
quercetin, rutin, etc. The formulations are useful to combat ageing of the
2 Lanzendorfer et al., US 2002/0099095 Al, published July 25,
2002 ("Lanzendorfer").
3 Tsuruga et al., Biologically Active Constituents of Magnolia
salicifolia: Inhibitiors of Induced Histamine Release from Rat
Mast Cells, 39 CHEM. PHARM. BULL. 3265-71 (1991) ("Tsuruga").
4 F .L. Pearce and A. Truneh, Inhibition of histamine release from
rat peritoneal mast cells treated with the ionophore A2 318 7.
Implications for the mode of action of anti-allergic compounds, 11
AGENTS AND ACTIONS 44--50 (1981) ("Pearce").
5 Menendez et al., US 4,882,170, issued Nov. 21, 1989
("Menendez").
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Appeal2014-004433
Application 12/107,526
skin and inflammation reaction" and that "[t]opical application is the
preferred means of applying the formulation" (Ans. 3).
The Examiner acknowledges that "Lanzendorfer does not teach the
use of tiliroside in the cosmetic formulation" (Ans. 4).
The Examiner finds that "Tsuruga teaches that the extracts of the
flower buds Magnolia salicifolia show remarkable anti-allergy effects" and
that "[a]saryladehyde and tiliroside ... were the most effective at inhibiting
histamine release" (Ans. 4). The Examiner finds that Pearce teaches
"inhibition of histamine release from rat peritoneal mast cells. Antiallergy
drugs such as quercetin, doxantrazole, etc. are shown to inhibit the release of
histamine" (Id.). The Examiner finds that Menendez teaches "a method for
the prevention or inhibition of an allergy reaction or tissue inflammation,
which comprises the administration of an anti-allergy drug" (Id.).
The Examiner finds it obvious
that tiliroside and quercetin are functional equivalents, as they
are both taught by the prior art to have anti-allergy properties
which inhibit the release of histamine. Thus it would be
obvious to substitute quercetin for the tiliroside of Tsuruga,
with a reasonable expectation of success. Furthermore,
Menendez demonstrates that it's well known in the art to
administer topical compositions which inhibit the release of
histamine
(Ans. 5).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Lanzendorfer, Tsuruga,
Pearce, and Menendez render the claims obvious?
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Appeal2014-004433
Application 12/107,526
Findings of Fact
1. In response to a requirement by the Examiner to elect a species
for examination, Appellants elected tiliroside as the compound of formula I
(see Resp. to Restriction Requirement 6/23/2011 ).
2. Lanzendorfer teaches "cosmetic and dermatological
formulations comprising flavonoids, their glycosides and, if appropriate,
combinations thereof' (Lanzendorfer i-f 1 ).
3. Lanzendorfer teaches "to choose the flavonoid or flavonoids A)
from the group consisting of quercetin" and "to choose the flavone
glycosides A) from the group consisting of rutin" (Lanzendorfer i-fi-154--55).
4. Lanzendorfer teaches "the use of the active compounds or
active compound combinations according to the invention for combatting
and/or prophylaxis of ageing of the skin and inflammatory reactions caused
by exposure to oxidation" (Lanzendorfer i-f 105).
5. Lanzendorfer teaches that "[t]opical application is preferred for
this use" (Lanzendorfer i-f 110).
6. Tsuruga teaches the "extracts of the flower buds of Magnolica
salicifolia showed remarkable anti-allergy effects in passive cutaneous
anaphylaxis (PCA) test" (Tsuruga, Abstract).
7. Tsuruga teaches that to "isolate bioactive compounds contained
in the methanol extract [of Magnolica salicifolia] it was fractionated ...
MG-9 was identified as tiliroside (11) ... and MG-10 as acteoside (12)"
(Tsuruga 3267-3268).
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Appeal2014-004433
Application 12/107,526
8. Table Ill of Tsuruga is reproduced below:
'1\'\~E lit J~t:H·sh~~:rr EHl':\.:~'S ($f t-~~ah-::J. {\~-tn~~~:r.=~$ ~~""">.~: l~-t~~Jt~:ifr.$
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Contpi:f1rnd 48/~) ~)l" (\m A
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As+.'lr):fakklw~.e (li ~ j?" 46 .·.·~
:l.;4---Dimo;:tlw~yd~~i:s;irns:<)''l· 0 .... ,l % ··'' ~~~<.•hd{J)
~-t~.tr:(~~t~x~~::~ (4) l~ ···4 ~ ~
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T!r·i!~£itk (ll) :'i'> ~~~} 5i :'IS
A~t~osid(:' {l~} 4~ 1l §l 24
"'""'-"'-'-"-'-"""""""'"· ... -.-.-.-.-.-.-.-.-.-...... .,..,..,.._ .......... •.•.•······---.-·····--············---------""'~~ ................. .._,_,_,_.._._.._ .................... .
"Table III summarizes the inhibitory activities of the isolated compounds on
histamine release from rat mast cells induced by compound 48/80 or Con A.
Asaryladehyde (2) and tiliroside (11) were the most effective in the
experiments where compound 48/80 was used as an inducer" (Tsuruga
3268).
9. Pearce teaches "quercetin, doxantrazole and theophylline
effectively inhibited histamine secretion in calcium-free media, in both the
presence and absence of the chelating agent" (Pearce 46, col. 2 to 47, col. 1).
10. Pearce teaches that the "secretion of chemical mediators
(principally the vasoactive amine histamine) from the mast cell is of great
clinical interest because of the involvement of these substances in allergic
and inflammatory conditions" (Pearce 44, col. 1 ).
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Appeal2014-004433
Application 12/107,526
11. Menendez teaches "prevention or inhibition of an allergic
reaction or tissue inflammation . . . which method comprises administration
by inhalation of an anti-allergy drug to a patient" (Menendez, Abstract).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007).
Analysis
Claim 1
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 3-5; FF 1-11) and agree that the
claims are obvious over Lanzendorfer, Tsuruga, Pearce, and Menendez. We
address Appellants' arguments below.
Appellants contend that:
it is to be noted that Pearce's own disclosure refutes the
PTO' s assertion with respect to the use of tiliroside in
inhibiting histamine release. Since Pearce explicitly states
that the mechanism of histamine release is unclear, there is
no suggestion or motivation for one skilled in the art to use
Tsuruga's compounds in a manner taught by Pearce because
nothing in the cited documents points to the compounds
(e.g., quercitin and tiliroside) being functional equivalents of
one another.
(App. Br. 6).
We are not persuaded. Pearce teaches that histamines are involved
with inflammatory conditions (FF 10). Pearce further teaches that
"quercetin, doxantrazole and theophylline effectively inhibited histamine
secretion" (FF 9). Tsuruga teaches that tiliroside was also an effective
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Appeal2014-004433
Application 12/107,526
inhibitor of histamine release (FF 8). Thus, the ordinary artisan would have
recognized that quercetin and tiliroside are equivalent for the purpose of
inhibiting histamine release. These teachings, combined with
Lanzendorfer's teaching to topically apply compounds including quercetin
to treat or prevent inflammation (FF 3-5), reasonably would have rendered it
obvious to the ordinary artisan to apply known equivalent compounds that
have anti-histamine and consequent anti-inflammatory activity such as the
tiliroside of Tsuruga (FF 8).
We recognize, but find unpersuasive, Appellants' contention
that the generic anti-allergic properties of the compounds do not
provide credence to the Examiner's broad assertion of
functional equivalency. In fact, based purely on the different
structural features and the properties of the respective
compounds in cosmetic formulations, it is submitted that the
Examiner's assertion regarding functional equivalency is
without merit.
Functional equivalency does not require structural similarity, as
shown in KSR itself, where the mechanical ("Asano ... and the Rixon ... are
complex mechanical linkage-based devices") and electrical ("an adjustable
pedal with a single pivot reflecting pedal position combined with an
electronic control") pedals differed substantially in structure but represented
"the mere substitution of one element for another known in the field." KSR,
550 U.S. at 416, 423. Therefore, when the Examiner finds it obvious to
utilize a known anti-histamine, tiliroside, in the place of another known anti-
histamine, quercetin, even though they differ structurally, this substitution is
a predictable use of prior art elements according to their established
functions.
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Appeal2014-004433
Application 12/107,526
Appellants contend that "[t]iliroside is an exceptional flavonoid
wherein the monoglycoside is further modified by a coumaric acid residue.
The lipophilic coumaric acid residue strongly influences the solubility, the
color and the stability of tiliroside in comparison to other flavonoids such as
quercetin" (App. Br. 6).
We find this argument unpersuasive because this represents attorney
argument, not evidence. Appellants provide no evidence that tiliroside
would have been expected to have unexpected properties relative to
quercetin, but simply argue this point. However, "attorney argument [is] not
the kind of factual evidence that is required to rebut a prima facie case of
obviousness." In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
Appellants contend that
Tsuruga generically points to a use of tiliroside compounds
against allergies, but provides no hint or suggestion for
formulating cosmetic compositions for topical administration.
It should be noted in this context that the in vitro tests disclosed
in Tsuruga do not suggest that tiliroside can be substituted for
quercitin and used in Lanzendorfer' s cosmetic formulations.
(App. Br. 7).
We find this argument unpersuasive because the Examiner relies upon
a combination of references, not Tsuruga alone, to render the claims
obvious. In particular, Lanzendorfer teaches that "[t]opical application is
preferred" (FF 5) for cosmetics (FF 2). "Non-obviousness cannot be
established by attacking references individually where the rejection is based
upon the teachings of a combination of references." In re Merck & Co., 800
F.2d 1091, 1097 (Fed. Cir. 1986).
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Appeal2014-004433
Application 12/107,526
Appellants contend that:
The facts in the instant case are analogous to that in [Leo
Pharm. Prods., Ltd v. Rea, 726 F.3d 1346, 1354 (Fed. Cir.
2013)]. Nothing in the disclosures cited by the PTO teach or
suggest topically treating inflammation or filtering UV
radiation comprising topically administering compounds of
Formula I or pharmaceutical compositions comprising the
same. Until the advancement made by the inventors of the
instant application, no one had proposed a new formulation that
could be applied topically to treat inflammation or filter UV
radiation.
(App. Br. 8).
We find this argument unpersuasive because Lanzendorfer
specifically teaches cosmetic formulations comprising flavonoids (FF 2) for
treatment of inflammation (FF 4) by topical application (FF 5). Appellants'
own Specification recognizes that tiliroside is a known prior art flavonoid
(see, e.g., Spec 24:25-27). Therefore, the Examiner reasonably finds it
\'l/ould have been obvious to use kno\'l/n prior art flavonoids that inhibit
histamine (FF 8) and are therefore anti-inflammatory (FF 10) in the cosmetic
containing flavonoids of Lanzendorfer that is designed for treatment of
inflammation (FF 4).
Appellants contend that the "passage of time between public
availability of the cited references is also evidence for the instantly claimed
invention not being obvious to try. Tsuruga, which generically teaches
quercetin compounds extracted from plants, was published 11 years before
the filing date of the instant application" (App. Br. 9).
We are not persuaded. "The mere age of the references is not
persuasive of the unobviousness of the combination of their teachings,
absent evidence that, notwithstanding knowledge of the references, the art
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Application 12/107,526
tried and failed to solve the problem." Jn re Wright, 569 F.2d 1124, 1127
(CCP A 1977). Appellants have provided no evidence addressing this point.
Appellants contend that "the claimed invention is directed to methods
for 'topically treating inflammation or filtering UV radiation comprising
topically administering compounds of Formula I' [.] These are not
compositions claims which merely recite the intended use" (App. Br. 9).
While we agree with Appellants that the process step of "treating
inflammation or filtering UV radiation" is not an intended use recitation, we
agree with the Examiner that regarding "the method of treating
inflammation, this is taught by Lanzendorfer" (Ans. 9). That is,
Lanzendorfer teaches a method of treating inflammation (FF 4), and the
combination of references renders the use of tiliroside in that method
obvious, not simply rendering the product itself obvious.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
Lanzendorfer, Tsuruga, Pearce, and Menendez render the claims obvious.
SUMMARY
In summary, we affirm the rejection of claims 16-23 and 29-35 under
35 U.S.C. § 103(a) as obvious over Lanzendorfer, Tsuruga, Pearce, and
Menendez.
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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