Ex Parte Wirth et al

Patent Trial and Appeal Board

Oct 20, 2014

10468708 (P.T.A.B. Oct. 20, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte CORINNA WIRTH,
HERWIG BUCCHOLZ, and CHRISTOPHE CAROLA
__________

Appeal 2012-004782
Application 10/468,708
Technology Center 1600
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a
cosmetic formulation. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Appellants identify the Real Party in Interest as Merck Patent
GMBH (App. Br. 1).
Appeal 2012-004782
Application 10/468,708

2
Statement of the Case
The Claims
Claims 2–4, 6–8, 11, 17–21, 23, and 30–37 are on appeal. Claim 2 is
representative and reads as follows:
2. A cosmetic formulation comprising a cosmetically suitable
amount of 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,
R4 is a mono- or diglycoside radical, wherein

is bonded to the glycoside radical via an -O- group, and
R8 is OH, CH3COO, an alkoxy radical having from 1 to 8 carbon
atoms or a monoglycoside radical, 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 in which, in each case independently of one another,
sulfate or phosphate groups 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 excipient or adjuvant for topical
application to treat inflammation topically, with the proviso that the
composition does not include any other active ingredient.
Appeal 2012-004782
Application 10/468,708

3

The Issues
A. The Examiner rejected claims 2–4, 6, 7, 17–21, 23, 30, and 37 under
35 U.S.C. § 103(a) as obvious over Tsuruga2 and Durant3 (Ans. 4–6).
B. The Examiner rejected claims 8, 11, and 31–36 under 35 U.S.C.
§ 103(a) as obvious over Tsuruga, Durant, and Takahashi4 (Ans. 6–8).5
A. 35 U.S.C. § 103(a) over Tsuruga and Durant
The Examiner finds that “Tsuruga teaches that the extracts of the
flower buds Magnolia salicifolia show remarkable anti-allergy effects”
(Ans. 4). The Examiner finds that Tsuruga teaches that “[a]saryladehyde
and tiliroside . . . were the most effective at inhibiting histamine release”
(Ans. 5). The Examiner acknowledges that “Tsuruga fails to teach tiliroside
to be present in a cosmetic” (id.).
The Examiner finds that Durant teaches “inhibitors of histamine
activity (Abs). Pharmaceutical compositions comprising the compound and
a carrier can be created” (id.). The Examiner finds it obvious to “utilize the
tiliroside of Tsuruga to create a composition that inhibits the release of
histamine for topical application . . . [with] a reasonable expectation of

2 Tsuruga et al., Biologically Active Constituents of Magnolia
salicifolia: Inhibitiors [sic] of Induced Histamine Release from Rat
Mast Cells, 39 CHEM. PHARM. BULL. 3265–3271 (1991).
3 Durant et al., US 3,920,822, issued Nov. 18, 1975.
4 Takahashi et al., US 6,245,795 B1, issued June 12, 2001.
5 The Examiner’s statement of this rejection in the Answer does
not include claim 31 (Ans. 6) but claim 31 was included in this
rejection in the final rejection (Office Action mailed March 30,
2011, page 5). We therefore understand the omission of claim 31
in the Answer to be a typographical error. Appellants understood
the rejection to apply to claims 8, 11, and 31–36 (Appeal Br. 3).
Appeal 2012-004782
Application 10/468,708

4
success as Durant teaches that compounds that inhibit the activity of
histamine can be utilized in pharmaceutical compositions which are applied
topically” (id.).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Tsuruga and Durant render the
claims obvious?
Findings of Fact
1. The Specification teaches that “[k]nown compounds of the
formula I are, for example, kaempferol 3-(6"-galloylglucoside) and
kaempferol 3-(6"-p-coumarylglucoside), which is also known as tiliroside”
(Spec. 8, ll. 29–31).
2. Tsuruga teaches that “[t]o isolate bioactive compounds
contained in the methanol extract [of Magnolia salicifolia] it was
fractionated . . . MG-9 was identified as tiliroside (11)” (Tsuruga 3267–
3268).
3. Table III of Tsuruga is reproduced below:
Appeal 2012-004782
Application 10/468,708

5

“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).
4. Durant teaches that the
[T]ype of action of histamine which is blocked by drugs
commonly called “antihistamines” . . . is believed to involve
a receptor which has been designated as H-1. A further
group of substances has recently been described . . . which
are distinguished by the fact that they act at histamine
receptors other than the H-1 receptor and these other
receptors have been designated as H-2 receptors.

(Durant, col. 1, ll. 21–29.)
5. Durant teaches that “the compounds represented by Formula I
have been found to have pharmacological activity in the animal body as
antagonists to certain actions of histamine” (Durant, col. 3, ll. 36–39).
Appeal 2012-004782
Application 10/468,708

6
6. Durant teaches that “[a]dvantageously the compositions will be
made up in a dosage unit form appropriate to the desired mode of
administration, for example . . . as a cream for topical administration”
(Durant, col. 4, ll. 49–53).
7. Durant teaches that the “active ingredient will be present in the
composition in an effective amount to inhibit histamine activity” (Durant,
col. 4, ll. 24–25).
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’l 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. 4–8; FF 1–6) and agree that the
claims are obvious over Tsuruga and Durant. We address Appellants’
arguments below.
Appellants contend that:
One of ordinary skill in the art would therefore not
have been motivated at all or not have had any reason
otherwise to substitute the “compound inhibiting H-2
histamine receptors” of Durant with a “compound inhibiting
histamine release” like tiliroside. The Office Action’s
allegations are based on hindsight, and not on a rationale
that would be accepted by one of ordinary skill in the art.

(Br. 3.)
We are not persuaded. Tsuruga teaches that tiliroside was an effective
inhibitor of histamine release from rat mast cells (FF 2–3), while Durant
Appeal 2012-004782
Application 10/468,708

7
teaches that antihistamine compounds may be formulated for topical
administration (FF 4–6). Although the specific mechanism of operation of
tiliroside may differ from the antihistamine compounds taught by Durant, a
skilled artisan would have found sufficient motivation to formulate tiliroside
as a topical composition given Durant’s teaching that topical administration
can inhibit histamine activity (FF 6).
With regard to the issue of hindsight, we find that the ordinary artisan,
aware of the histamine inhibitor activity of tiliroside, would have had ample
reason to use this known compound with a known activity in a topical
formulation for antihistamines (FF 2–6).
Appellants contend that “[t]here is nothing in the prior art that would
provide a reasonable expectation of success, e.g., expectation of efficacy,
from a cosmetic composition in which tiliroside is present” (Br. 4).
We are not persuaded. We first note that the preamble’s recitation of
“cosmetic formulation” represents a non-limiting intended use of the
claimed composition. A preamble is not limiting “‘where a patentee defines
a structurally complete invention in the claim body and uses the preamble
only to state a purpose or intended use for the invention.’” Catalina Mktg.
Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002). In
the instant case, the body of claim 2 provides a structurally complete
composition composed of tiliroside (or other formula IA compounds) and an
adjuvant. Thus, regardless of whether it would be labeled as a “cosmetic
formulation,” the obvious formulation of Tsuruga’s tiliroside into a topical
cream will be structurally identical to the claimed composition (FF 2–6).
See In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“Products of identical
chemical composition can not have mutually exclusive properties.”).
Appeal 2012-004782
Application 10/468,708

8
Further, we find there would be a reasonable expectation of success in
making the claimed composition since Durant teaches that antihistamine
compounds may be formulated topically (FF 6). As O’Farrell notes
“[o]bviousness does not require absolute predictability of success . . . all that
is required is a reasonable expectation of success.”’ In re O’Farrell, 853
F.2d 894, 903–904 (Fed. Cir. 1988); see also Hoffmann-La Roche Inc. v.
Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014) (“Conclusive proof of
efficacy is not necessary to show obviousness.”).
Appellants contend that under the Examiner’s rationale
[A]ll these different types of compounds, having different
effects and at different sites, would be considered “histamine
compounds” and would all be interchangeably usable in the
same types of formulations. Such a rationale is not
scientifically defensible, not based on evidence, and thus
cannot serve as a valid rationale in support of an allegation
of obviousness.

(Br. 5.)
We are not persuaded. We agree with the Examiner that Appellants’
hypothetical fails to address the specific rejection at issue, which is the
obviousness of a topical formulation of tiliroside (Ans. 8–9). Appellants
provide no evidence to suggest that the topical administration of an inhibitor
of histamine release from mast cells would not function in the manner
expected. Indeed, Appellants acknowledge that the H1 histamine receptor is
“responsible for hives . . . and pain and itching due to insect stings” (Br. 5).
Thus, the ordinary artisan, aware that tiliroside inhibits histamine release (FF
2–3), would have reasonably expected that the topical administration of such
an inhibitor would prevent any release of histamine and further prevent
Appeal 2012-004782
Application 10/468,708

9
subsequent binding of histamine to the H1 histamine receptor, thereby
leading to reduced hives as well as pain and itching due to insect stings.
Claim 30
Appellants provide no clear definition of the scope of “‘consisting
essentially of’” in the Specification, and absent a clear indication in the
Specification or claims of what the basic and novel characteristics of the
claimed device actually are, the term “‘consisting essentially of’” is
construed as equivalent to “‘comprising.’” PPG Industries v. Guardian
Industries Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998). We therefore find
claim 30 obvious for the same reasons given above for claim 1.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Tsuruga and Durant render the claims obvious.
B. 35 U.S.C. § 103(a) over Tsuruga, Durant, and Takahashi
Appellants contend that “any optimization based on the disclosure of
Takahas[h]i would be understood to be only in the context of the disclosure
therein, where its purpose is explicitly disclosed to be to supplement or
render effective an H2 antagonist” (Br. 6).
The Examiner responds that “Takahas[h]i is solely relied upon to
demonstrate that the concept of optimization of histamine inhibitors is well-
known in the art, as Takahas[h]i teaches that the amount of histamine
inhibitor used varies depending on the subject to which the composition is
used or applied” (Ans. 9).
We find that the Examiner has the better position. Tsuruga teaches
testing two different tiliroside concentrations (FF 3) and Durant teaches that
the “active ingredient will be present in the composition in an effective
Appeal 2012-004782
Application 10/468,708

10
amount to inhibit histamine activity” (Durant, col. 4, ll. 24–25; FF 7). These
teachings, as well as Takahashi’s teaching of optimization of compound
amounts (see Takahashi, col. 3, ll. 15–22), reasonably demonstrate that the
amount of active compound is a results-optimizable variable. The discovery
of an optimum value of a result-effective variable in a known process is
prima facie obvious. In re Antonie, 559 F.2d 618, 620 (CCPA 1977). See,
e.g., In re Boesch, 617 F.2d 272, 275 (CCPA 1980) (“This accords with the
rule that discovery of an optimum value of a result effective variable in a
known process is ordinarily within the skill of the art.”) Appellants provide
no evidence demonstrating any secondary considerations, including
unexpected results, in order to rebut the Examiner’s prima facie showing.
SUMMARY
In summary, we affirm the rejection of claims 2 and 30 under
35 U.S.C. § 103(a) as obvious over Tsuruga and Durant. Pursuant to
37 C.F.R. § 41.37(c), we also affirm the rejection of claims 3, 4, 6, 7, 17–21,
23, and 37, as these claims were not argued separately.
We affirm the rejection of claims 8, 11, and 31–36 under 35 U.S.C.
§ 103(a) as obvious over Tsuruga, Durant, and Takahashi.

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

cdc