Ex Parte Sakamoto et al

Patent Trial and Appeal Board

Nov 29, 2012

12128137 (P.T.A.B. Nov. 29, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
12/128,137 05/28/2008 Kenji Sakamoto SAKA 0104 PUSA 9760
22045 7590 11/29/2012
BROOKS KUSHMAN P.C.
1000 TOWN CENTER
TWENTY-SECOND FLOOR
SOUTHFIELD, MI 48075
EXAMINER
VU, JAKE MINH
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
11/29/2012 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte KENJI SAKAMOTO and KEISHI HATA
__________

Appeal 2012-001937
Application 12/128,137
Technology Center 1600
__________

Before DEMETRA J. MILLS, MELANIE L. McCOLLUM, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

SNEDDEN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
of manufacturing a composition for ameliorating skin pigmentation. The
Examiner has rejected the claims as anticipated and nonenabled. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

App
App

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ts, and to c
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Claims 1
1.
preventi
method
ob
the form

in
in the liq

Amendm
aim 1 of th
ppellants’
nd in the
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dments (A
claim 1 o
aring this d
ndment en
01937
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ts’ invent
ompositio
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in the mel
esented in
inhibitor a
and 5 are
A method
ng, treatin
comprising
taining a l
ula (1) as
creasing th
uid mixtu

ent entered
e structure
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Amendme
ction, 2.)
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f the Claim
ecision, w
tered Nov
ATEMEN
ion relates
ns thereof
ns, and fo
anocytes.”
the Specif
nd previo
on appeal
of manuf
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of formu
rs from th
nt of Nov
Appellant
and thus
s Append
e referenc
ember 10,
2
T OF TH
to “melan
, particula
ods which
(Spec. 1
ication by
usly know
and provi
acturing a
rating ski
ture of an
ngredient:
ration of th
er 10, 201
la (1) prov
e structure
ember 10,
s have not
we unders
ix of App
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2010.
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ogenesis i
rly to cosm
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, ll. 20-23.
Formula (
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ergosterol

(1); and
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of formul
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) The ergo
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e. (Spec.
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on for
ation, the
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ol derivat
e that the r
Claims A
a (1) recit
red into th
itional cla
citation of
rief to be i
ted in the
whitening
gs,
iting
sterol
3, ll. 17-
of
ive
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im
formula
n error. In

Appeal 2012-001937
Application 12/128,137

3

5. The method of claim 1, further comprising chemically
synthesizing the ergosterol derivative of the formula (1).

The claims stand rejected as follows:
I. Claim 1 under 35 U.S.C. § 102(b) as being anticipated by Yuusuke
(JP02-049710; references are made to the English translation
submitted January 22, 2007 in Appellants’ parent U.S. Application
10/399,029) as evidenced by Ishizuka et al. (Sterol constituents
from the fruit bodies of Grifola frondosa. CHEM PHARM BULL.
1997; 45(11):1756-1760).
II. Claim 5 under 35 U.S.C. § 112, first paragraph, as failing to
comply with the enablement requirement.
I.
Issue
The Examiner has rejected claim 1 under 35 U.S.C. § 102(b) as being
anticipated by Yuusuke as evidenced by Ishizuka. The Examiner finds that
Yuusuke “teaches a composition comprised of an extract[ion], which would
read on manufacturing, from Grifola frondosa that has a skin whitening
effect.” (Ans. 7.)
Appellants contend that “Yuusuke as evidenced by Isizuka does not
necessarily disclose a cosmetic blend containing the one particular ergosterol
of formula (1) out of the at least 19 different sterol constituents in Grifola
Frondosa, which in turn is one of 6 different species in Yuusuke as
evidenced by Ishizuka.” (Reply Br. 3.)
The issue with respect to this rejection is:
Appeal 2012-001937
Application 12/128,137

4
Does Yuusuke disclose, either explicitly or inherently, each and every
element of claim 1?
Findings of Fact
FF1. Yuusuke discloses compositions prepared by “compounding one
or more extracts selected from a group of extracts extracted from respective
fruit bodies of Polyporus confluens Pr., Rozites caperata (Pers. ex Pr.)
Karst., Lyophyllum shimeji (Kawam.) Hongo, Russula lilacea Que1,
Ramaria fumigate K. Yokoyama and Grifola frondosa (Dicks. ex Pr.) S.F.
Gray with water and/or organic solvent.” (Yuusuke, 2.)
FF2. Yuusuke discloses an “extraction operation …in which the
various effective substances …[are] extracted from the aforementioned
various fruit bodies with the aforementioned various extraction solvents
(water and/or organic solvent).” (Yuusuke, 13.)
FF3. Yuusuke discloses that the yield of the various extracts is
controlled “by distilling off the solvent and the like, as needed.” (Yuusuke,
13; see also Yuusuke, 24-25 (disclosing that viscous substance content is
concentrated to 20mL).)
FF4. Ishizuka discloses that extracts from Grifola frondosa contains
ergosterol and the ergosterol derivative of formula (I). (See Ishizuka, 1756,
formula on bottom left side of Chart 1.)
FF5. Ishizuka discloses that the compound of formula (I) was
obtained from ethanol extracts from fresh fruit bodies of Grifola frondosa
and fractions separated on a column. (See Ishizuka, 1759, left col. under the
heading Extraction and Isolation.)
Appeal 2012-001937
Application 12/128,137

5
Principles of Law
Anticipation requires that every element and limitation of the claimed
invention must be found in a single prior art reference, arranged as in the
claim. Brown v. 3M, 265 F.3d 1349, 135 (Fed. Cir. 2001).
“[W]here the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the claimed
subject matter may, in fact, be an inherent characteristic of the prior art, it
possesses the authority to require the applicant to prove that the subject
matter shown to be in the prior art does not possess the characteristic relied
on.” In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). This flexibility in
the burden of proof placed on the Patent Office is afforded because “[a]s a
practical matter, the Patent Office is not equipped to manufacture products
by the myriad of processes put before it and then obtain prior art products
and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535
(CCPA 1972). In order to shift the burden of proof, the Examiner must
provide evidence or reasoning to establish a sound basis for the Examiner's
belief that the missing descriptive matter is necessarily present in the
reference. See In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). Once the
Examiner has done this, the burden to overcome, with argument or evidence,
the apparent identity of Appellants’ claimed device and that of the prior art
shifts to Appellants. Id.
Analysis
Yussuke discloses compositions containing extracts from Grifola
frondosa (FF1 and FF2) where the yield of the extract is controlled by
distillation (FF3). Ishizuka discloses that extracts from Grifola frondosa
Appeal 2012-001937
Application 12/128,137

6
contain the ergosterol derivative of the formula (1). (FF4 and FF5.) From
these facts, the Examiner reasoned that extracts from Grifola frondosa
contain the recited the ergosterol derivative, and as such, the compositions of
Yussuke “would contain all ergosterols and are concentrated during the
distilling phase of the solvent.” (Ans. 16.) Appellants argue that the
cosmetic blend of Yuusuke would not necessarily contain the “one particular
ergosterol of formula (1) out of the at least 19 different sterol constituents in
Grifola Frondosa, which in turn is one of 6 different species in Yuusuke.”
(Reply Br. 3.)
We are not persuaded by Appellants arguments. The distilled Grifola
frondosa extracts of Yuusuke (FF3) or the fractionated Grifola frondosa
extracts of Ishizuka (FF5) are each produced by methods that include the
steps of obtaining liquid extracts of Grifola frondosa and increasing the
concentration of active ingredients therein either by distillation (FF3) or
fractionation (FF5). We thus find Yuusuke as evidenced by Ishizuka to
anticipate claim 1.
With regard to Appellants inherency argument, we find that the
burden of proof was on Appellants to establish that the extracts produced by
Yuusuke would not contain the ergosterol derivative of the formula (1) and
that this burden was not met. There is no evidence of record to support a
finding that the particular extracts of Grifola frondosa taught in Yuusuke
would not contain the claimed ergosterol derivative. Rather, we agree with
the Examiner that an extract of Grifola frondosa would contain all of the
ergosterol derivatives, as evidenced by Ishizuka. (FF4 and FF5). While the
distillation process of Yuusuke would increase the concentration of each of
Appeal 2012-001937
Application 12/128,137

7
the ergosterol derivatives contained in an extraction liquid, the claims are
not limited to only increasing the concentration of the ergosterol derivative
of the formula (1).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Yuusuke anticipates the method of claim 1.

II.
Issue
The Examiner has rejected claim 5 under 35 U.S.C. § 112, first
paragraph, for lack of enablement. The Examiner makes the following
findings:
There is nothing in the specification that disclosed the
starting compounds to synthesize formula (I) or the steps in
producing formula (I) chemically. Guidance for preparing
formula (I) by isolating from Ganoderma lucidum is provided
in the specification. However, there is a substantial gap between
chemically synthesizing the unknown starting compounds and
the final product of formula I. Consequently, a burdensome
amount of research would be required by one of ordinary skill
in the art to bridge this gap.
…
Appellant fails to provide examples showing that the chemical
synthesis of formula (I).

(Ans. 5-6.)
Appellants submit Exhibit 1 as evidence “that chemical synthesis of
ergosterol derivative of formula (1) was within the practice capacity of the
one skilled in the art at the time of filing this application.” (App. Br. 4-5.)
Appeal 2012-001937
Application 12/128,137

8
The issue with respect to this rejection is:
Whether the Examiner has provided sufficient evidence to support the
conclusion that the Specification lacks enablement of the subject matter of
claim 5.
Additional Findings of Fact
FF6. The Specification page 3 discloses that the structure of the
ergosterol derivative of formula (I) was known at the time of filing of the
application as in Ishizuka. (See also Ishizuka, 1756, formula on bottom left
side of Chart 1.)
FF7. Appellants’ Exhibit I (Windaus et al., “Photochemical
oxidation of ergosterol”, CHEMICAL ABSTRACTS 22:3666-67 (1928)) discusses
the photochemical oxidation of ergosterol to “ergosterol peroxide.” (App.
Br., Exhibit 1.)
Principles of Law
The examiner bears the initial burden of setting forth a reasonable
explanation as to why the scope of protection provided by the claims is
thought to be not adequately enabled by the description of the invention
provided in the specification. If that burden is met, the burden then shifts to
the applicant to provide proof that the specification is indeed enabling. In re
Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993). “[T]he Patent and
Trademark Office must substantiate its rejection for lack of enablement with
reasons.” In re Armbruster, 512 F.2d 676, 677 (CCPA 1975) (emphasis in
original).

Appeal 2012-001937
Application 12/128,137

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“‘The enablement requirement is met if the description enables any
mode of making and using the invention.’” Johns Hopkins Univ. v. Cellpro
Inc., 152 F.3d 1342, 1361 (Fed. Cir. 1998) (quoting Engel Indus., Inc. v.
Lockformer Co., 946 F.2d 1528, 1533 (Fed. Cir. 1991)).
“[E]nablement requires that the specification teach those in the art to
make and use the invention without ‘undue experimentation.’ That some
experimentation may be required is not fatal; the issue is whether the amount
of experimentation required is not ‘undue.’” In re Vaeck, 947 F.2d 488, 495
(Fed. Cir. 1991) (citation omitted, emphasis in original). “Whether undue
experimentation is needed is not a single, simple factual determination, but
rather is a conclusion reached by weighing many factual considerations.” In
re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). The factual considerations
discussed in Wands are: (1) the quantity of experimentation necessary to
practice the invention, (2) the amount of direction or guidance presented, (3)
the presence or absence of working examples, (4) the nature of the
invention, (5) the state of the prior art, (6) the relative skill of those in the
art, (7) the predictability or unpredictability of the art, and (8) the breadth of
the claims. Id.
The specification need not disclose what is well known in the art.
Lindemann Maschinenfabrik GmbH v. American Hoist & Derrick Co., 730
F.2d 1452, 1463 (Fed. Cir. 1984).

Analysis
Appellants essentially claim a method of manufacturing a
composition for preventing, treating or ameliorating skin
Appeal 2012-001937
Application 12/128,137

10
pigmentation, where the method comprises 1) obtaining a liquid
mixture of an ergosterol derivative of the formula (1), a known
compound, as an active ingredient and 2) increasing the concentration
of the ergosterol derivative in the liquid mixture. Claim 5, further
requires that the known compound of formula I be chemically
synthesized.
The Examiner’s position is that the Specification is not enabling
because the ergosterol derivative of the formula (1) could not be chemically
synthesized without undue experimentation and the Specification does not
describe a synthesis method. This position is not persuasive because it fails
to address and consider several factors with respect to establishing undue
experimentation, including (1) the quantity of experimentation necessary to
practice the invention, (4) the nature of the invention, (5) the state of the
prior art, (6) the relative skill of those in the art, and (7) the predictability or
unpredictability of the art.
Furthermore, the Examiner provides no reason to question enablement
based on the state of the art and does not provide any evidence that it would
have required undue experimentation at the filing date of the present
application to chemically synthesize for compound of formula I or the
concentrated ergosterol derivative of the method of claim 5.
As evidence of the state of the art Appellants argue that the ergosterol
and the ergosterol derivative of the formula (1) are known substances. (FF4
and FF6; see also Spec. 3, ll. 17-22.) Appellants submit Exhibit 1 as
evidence “that chemical synthesis of ergosterol derivative of formula (1) was
within the practice capacity of the one skilled in the art at the time of filing
Appeal 2012-001937
Application 12/128,137

11
this application.” (App. Br. 4-5.) Exhibit 1 details the photochemical
oxidation of ergosterol to ergosterol peroxide (FF7), which demonstrates to
us that the chemical synthesis of ergosterol derivatives was within reach of
those skilled in the art, especially where the structures of those derivatives
where known (FF4). The Examiner’s undue experimentation analysis is
deficient as the analysis excludes any meaningful discussion relevant to,
inter alia, the state of the prior art in view of Appellants’ evidence, an
important factor to be considered here in determining whether a disclosure
would require undue experimentation. In re Wands, 858 F.2d 731, 737 (Fed.
Cir. 1988).
Thus, the Examiner has not provided sufficient evidence to support
the conclusion that the Specification lacks enablement of the subject matter
of claim 5.2 We do not sustain the rejection of claim 5 under 35 U.S.C. §
112, first paragraph.

Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that claim 5 is not enabled.
SUMMARY
We affirm the rejection of claim 1 under 35 U.S.C. § 102(b) as being
anticipated by Yuusuke as evidenced by Ishizuka.

2 Claim 5 is not rejected over prior art on this record. Upon return of the
application to the Examiner, the Examiner should consider the relevance of
the art of record to pending claim 5.
Appeal 2012-001937
Application 12/128,137

12
We reverse the rejection of claim 5 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement.
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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