Toshihiko Hibino et al.

Patent Trials and Appeals Board

Dec 10, 2019

14004977 - (D) (P.T.A.B. Dec. 10, 2019)

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.
14/004,977 09/13/2013 Toshihiko Hibino 053466-0556 7122
22428 7590 12/10/2019
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
HOFFMAN, SUSAN COE
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
12/10/2019 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TOSHIHIKO HIBINO, SHOKO YAMADA, and
HIDEKAZU FUKUSHIMA
Appeal 2019-000566
Application 14/004,977
Technology Center 1600
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JOHN S. SCHNEIDER, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 4, 6, and 7. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as SHISEIDO
COMPANY, LTD. Br. 3.
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Application 14/004,977

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STATEMENT OF THE CASE
The Examiner finally rejected the claims as follows:
1. Claims 4 and 6 under 35 U.S.C. § 102(b) (2006) as anticipated by
Voegel (US 2010/0324111, published Dec. 23, 2010) (“Voegel”). Final Act.
2.
2. Claims 4 and 6 under 35 U.S.C. § 103(a) (2006) as obvious in view
of Voegel. Final Act. 3.
3. Claims 4, 6, and 7 pre-AIA 35 U.S.C. 103(a) as obvious in view of
Voegel and Kamata (Bleomycin Hydrolase Is Regulated Biphasically in a
Differentiation- and Cytokine-dependent Manner, J. Biol. Chem., 2011, Vol.
286 (10), 8204−12) (“Kamata”). Final Act. 4.
Independent claim 4 is representative and reproduced below:
4. A method for improving or preventing dry skin caused by
atopic dermatitis, comprising: applying a bleomycin hydrolase
production promoter comprising as an active ingredient thereof
one or more ingredients selected from the group consisting of
chestnut rose extract, benzenesulfonyl GABA and erythritol to
a non-lesion area of a subject in need of improvement or
prevention of dry skin caused by atopic dermatitis.

1. ANTICIPATION REJECTION
Claim 4 is directed to a method for improving or preventing dry skin
caused by atopic dermatitis. The method comprises applying a bleomycin
hydrolase production promoter “to a non-lesion area of a subject in need of
improvement or prevention of dry skin caused by atopic dermatitis.” The
elected promoter is “erythritol.” Final Act. 2.
The Examiner found that Voegel describes preventing and treating
atopic dermatitis with a composition that comprises erythritol. Final Act. 3.
The Examiner found that Voegel does not specifically disclose applying the
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erythritol composition to a non-lesion area of skin as required by the claim,
but the Examiner found “by teaching the prevention of atopic dermatitis,”
Voegel “is implicitly teaching that the erythritol composition should be
applied to skin prior to the outbreak of the lesion, i.e. non-lesioned skin.” Id.
Therefore, the Examiner concluded Voegel “is considered to teach applying
the erythritol to non-lesioned skin of a patient who suffers from atopic
dermatitis,” anticipating the claim. Id.
Appellant contends that “nowhere does Voegel disclose or suggest
that the non-lesion skin area is by any means associated with atopic
dermatitis, let alone, imply that there is any preventive role for erythritol to
play in the non-lesion region.” Appeal Br. 7. Appellant argues that Voegel
“only presents the fact that atopic dermatitis is characterized by ‘lesions.’”
Id. Appellant further argues that “Voegel implies that the non-lesion area is
not affected by atopic dermatitis. So assuming, arguendo, that Voegel taught
treatment of dry skin with erythritol, the only inherent teaching ‘necessarily
flow[ing]’ from Voegel is that erythritol can be applied to the ‘lesion,’ but
not to ‘non-lesion area,’ to prevent atopic dermatitis characterized by dry
skin.” Id. at 7–8.

FINDINGS OF FACT (“FF”)
FF1.
The present invention relates to combinations which are
particularly suitable for the treatment and/or prevention of
atopic dermatitis.
Voegel ¶ 1.

FF2.
Atopic dermatitis is a common condition in individuals of both
sexes, often from the age of three months, which is
characterized by repeating outbreaks of eczema on skin
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characterized by dry, squamous and highly pruriginous lesions.
It has been noted that dryness of the skin is one of the
predominant factors in the generation of atopic dermatitis.
Voegel ¶ 4.

FF3
In fact, the application of a combination or composition
containing pyrrolidone-5-carboxylic acid and at least one
compound from citrulline, arginine and asparagine, in racemic
or isomer form, and also salts thereof, has a moisturizing action
on this part of the skin, thereby leading to a significant effect
for the treatment of atopic dermatitis.
Voegel ¶ 8.

FF4.
A subject of the present invention is also the use of the
composition according to the invention in the preparation of a
medicament for use in the prevention and/or treatment of atopic
dermatitis (or eczema).
Voegel ¶ 15.

FF5.
The composition according to the invention is generally
suitable for topical application to the skin and it therefore
contains a physiologically acceptable medium, i.e. a medium
that is compatible with the skin.
Voegel ¶ 33.

FF6.
Humectants and moisturizers having the role of increasing the
water content of upper layer of skin such as Sodium PCA and
Arginine (both NMFs/Filaggrin breakdown produ[c]ts ),
Glycerol; Sorbitol; Aloe vera; Betaine; caprylyl glycol,
chitosan, cholesterol, Erythritol . . .
Voegel ¶ 49.

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FF7.
The moisturizing lotion according to the present is a non greasy
creamy oil in water emulsion, without preservative, allergens
and fragrance. It is designed to allow the dry skin to recover its
essential functions and healthy aspect.
Voegel ¶ 81.

FF8.
6. A method for treating and or preventing atopic dermatitis
wherein a composition according to claims 1 to 4 is
administrated to a subject in need thereof.
7. A method according to claim 6, wherein said composition is
administrated topically and/or applied on the skin surface.
Voegel, p. 8.
Discussion
Under 35 U.S.C. § 102 a claim is anticipated “if each and every
limitation is found either expressly or inherently in a single prior art
reference.” Celeritas Techs. Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354,
1361 (Fed. Cir. 1998). When inherency is a basis of anticipation, it “may
not be established by probabilities or possibilities. The mere fact that a
certain thing may result from a given set of circumstances is not sufficient.”
In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (internal citation and
quotation marks omitted). A “prior art reference may anticipate without
disclosing a feature of the claimed invention if that missing characteristic is
necessarily present, or inherent, in the single anticipating reference.”
SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343 (Fed. Cir.
2005).
The issue in this rejection is whether following Voegel’s disclosure to
prevent atopic dermatitis would necessarily result in “applying . . . erythritol
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to a non-lesion area of a subject in need of improvement or prevention of dry
skin caused by atopic dermatitis” as recited in claim 1.
The Examiner’s determination that the claim is anticipated by Voegel
is based on the finding that “by teaching the prevention of atopic dermatitis,
the reference is implicitly teaching that the erythritol composition should be
applied to skin prior to the outbreak of the lesion, i.e. non-lesioned skin.”
Final Act. 3.
The Examiner’s reasoning is supported by a preponderance of the
evidence.
Voegel describes applying its composition topically to the skin to treat
and prevent atopic dermatitis (FF1, FF4, FF5, FF8). Appellant did not
dispute that the composition can contain erythritol (FF6). Voegel teaches
treating atopic dermatitis by applying its composition “on this part of the
skin” (FF3). This “part” of the skin would be understood to be at least the
“dry, squamous and highly pruriginous lesions” which is characteristic of
atopic dermatitis. We reach this conclusion because the lesions are
indicative of atopic dermatitis (FF2) and therefore would be the part of the
skin when treatment is desired.
Voegel also teaches prevention of atopic dermatitis (FF1, FF4, FF8).
As indicated by the Examiner, Voegel does not explicitly disclose where to
topically apply the composition to the skin to prevent atopic dermatitis.
However, because the disease is characterized by “outbreaks of . . . dry,
squamous and highly pruriginous lesions” (FF2), the only logical conclusion
is that the composition would be applied to non-lesion skin to prevent the
outbreak of the characteristic pruriginous lesions.
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Appellant argues that there is no teaching in Voegel that “the non-
lesion skin area is by any means associated with atopic dermatitis” and “the
only inherent teaching ‘necessarily flow[ing]’ from Voegel is that erythritol
can be applied to the ‘lesion,’ but not to ‘non-lesion area,’ to prevent atopic
dermatitis characterized by dry skin.” Appeal Br. 7–8. We find this
argument unpersuasive because to apply the composition to lesions which
have already appeared would be considered treatment of atopic dermatitis
because it would be ameliorating symptoms of the disease. However,
Voegel also discloses prevention of atopic dermatitis (FF1, FF4). Appellant
has not identified where the composition would be applied to the skin to
prevent the outbreak of the lesions characteristic of atopic dermatitis, if not
to non-lesioned areas.
Appellant states that “Voegel implies that the non-lesion area is not
affected by atopic dermatitis” (Appeal Br. 7), but does not explain what
would be the appearance of the skin prior to the outbreak of lesions.
Appellant has not directed us to a definition of “non-lesion” skin area that
would distinguish it from the skin area in Voegel that the composition is
applied to prevent “outbreaks of eczema on skin characterized by dry,
squamous and highly pruriginous lesions” (FF2).
Appellant, citing Perricone v. Medicis Pharm. Corp., 432 F.3d 1368
(Fed. Cir. 2005), argues “a reference disclosing generalized topical
administration of skin care preparations cannot inherently teach a method
directed to a specific area of skin that the reference does not teach.” Appeal
Br. 9. The anticipation rejection here is distinguishable because the
Examiner is not relying on a general teaching to apply the composition to the
skin, but rather a specific disclosure in Voegel to apply the composition
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topically to prevent atopic dermatitis, which necessarily would mean
applying it to skin which is not experiencing an outbreak of lesions.
The Examiner further found that Voegel discloses the same
composition as claimed and thus would also “inherently have to result in the
promotion of bleomycin hydrolase” as claimed (Final Act. 4), in reference to
claim 4 of applying a bleomycin hydrolase production promoter and claim 6
of “promoting bleomycin hydrolase production.” Appellant contends that
the Examiner improperly relied on the disclosure in the Specification to
establish a link between erythritol and atopic dermatitis in making this
rejection. Appeal Br. 9–10; Reply Br. 2–3.
This argument does not persuade us that the Examiner erred.
Claim 6 is directed to a “method for promoting bleomycin hydrolase
production.” There is one recited step in the claim which comprises
administering erythritol “to a non-lesion area of a subject suffering from
atopic dermatitis and in need of promoting bleomycin hydrolase
production.”
It is well-established that merely recognizing a new benefit of an old
process is insufficient to render the old process again patentable. In re
Woodruff, 919 F.2d 1575 (Fed. Cir. 1990); MEHL/Biophile Int’l Corp. v.
Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999); In re Cruciferous Sprout
Litig., 301 F.3d 1343, 1351 (Fed. Cir. 2002); In re Omeprazole Patent Litig.,
483 F.3d 1364, 1373 (Fed. Cir. 2007).
In MEHL, 192 F.3d at 1365, the patentee claimed a “method of hair
depilation” utilizing steps which had been described in a prior art
publication. The prior art method did not perform the steps for the purpose
of hair depilation, but it was determined that hair depilation would have been
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a necessary, albeit unrecognized and inherent, consequence of carrying out
the method. MEHL, 192 F.3d at 1366. Although the claim preamble
expressly required the method to be performed for the purpose of hair
depilation, the court did not find it necessary that the article’s authors
“appreciate the results” of their process to constitute an anticipation of the
claimed process. Id. Here, while the claim preamble recites that the method
is for promoting bleomycin hydrolase production, the steps are the same as
those disclosed in Voegel and thus necessarily the same result is achieved.
Appellant has not provided evidence to rebut the Examiner’s fact-based
determination. The same rationale applies to claim 4.
Accordingly, we conclude that the Examiner correctly determined that
application of the claimed composition to non-lesion skin is “necessarily
present” in Voegel when its prevention is carried out. SmithKline Beecham
Corp. v. Apotex Corp., 403 F.3d at 1343. The rejection of claims 4 and 6 as
anticipated by Voegel is affirmed.

2. OBVIOUSNESS BASED ON VOEGEL
The Examiner found that Voegel also renders the claimed subject
matter obvious to one of ordinary skill in the art at the time of the invention.
The Examiner found, as discussed above, that Voegel teaches that
atopic dermatitis is characterized by lesions on the skin. Final Act. 4. The
Examiner further found that Voegel disclose that “skin dryness is a
predominant factor in the generation of atopic dermatitis.” Id. The
Examiner found that the skilled worker “would reasonably expect that the
prevention and treatment of atopic dermatitis could be carried out by
applying the erythritol composition to dry skin associated with atopic
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dermatitis prior to the development of lesions on the skin.” Id. The
Examiner concluded that this “reasonable expectation of success would
motivate the artisan to improve or prevent dry skin caused by atopic
dermatitis by applying the erythritol composition to non-lesioned areas of
the skin to prevent the development of the lesions” as required by the claims.
Id.
Appellant states that the Examiner is improperly relying on inherency
to establish obviousness. Appeal Br. 11.
This is argument does not identify an error in the Examiner’s
rejection. The Examiner found that the skilled worker, knowing that the
composition is useful to treat and prevent dry skin associated with atopic
dermatitis, would have found it obvious to apply it to dry skin prior to the
appearance of lesions, i.e., for the prevention of an outbreak of lesions.
Final Act. 4. Appellant has not identified a defect in this reasoning other
than to assert that it is based on the same faulty finding in the anticipation
rejection. Appeal Br. 11. However, this is not correct. The Examiner
clearly set forth a different basis for the obviousness rejection, namely, that a
skilled worker would have had reason to apply the composition to non-lesion
skin; inherency was not invoked.
For the foregoing reasons, the rejection of claims 4 and 6 as obvious
in view of Voegel is affirmed.

3. OBVIOUSNESS BASED ON VOEGEL AND KAMATA
Claim 7 depends from independent claim 4, and further recites
“evaluating the expression level of bleomycin hydrolase to identify a subject
in need of improvement or prevention of dry skin.”
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The Examiner acknowledged that Voegel does not describe the
claimed step, but found that “Kamata teaches that a loss of bleomycin
hydrolase leads to a deficiency in skin’s natural moisturizing factors which
leads to dry skin and atopic dermatitis.” Final Act. 5. The Examiner further
stated:
Thus, an individual with a lowered expression level of
bleomycin hydrolase would be recognized as an individual in
need of improvement or treatment of dry skin and atopic
dermatitis. An artisan of ordinary skill would be motivated to
treat this individual with known compositions for treating dry
skin and atopic dermatitis for improvement and would be
motivated to perform the evaluation to determine patients that
are in need of treatment for dry skin and atopic dermatitis.
Therefore, an artisan of ordinary skill would be motivated to
perform this evaluation prior to the dry skin and dermatitis
treatment taught by Voegel.
Final Act. 5.
Appellant makes the same unpersuasive argument about Voegel not
disclosing applying its composition to non-lesion skin. Appeal Br. 12.
Appellant also argues “there is no indication in Kamata that erythritol
compositions can elevate the production of bleomycin hydrolase in the
recited ‘non-lesion’ area.” Appeal Br. 12.
Appellant’s argument ignores the express language in the claim.
Claim 7 does not require knowledge that the erythritol is a bleomycin
hydrolase promoter. The claim only requires that expression is evaluated.
The Examiner gave a well-reasoned statement as to why one of ordinary
skill would have had reason to evaluate bleomycin hydrolase expression
after application of the composition described in Voegel. Appellant did not
identify a deficiency in the Examiner’s rejection and we find none.
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For the foregoing reasons, the rejection of claims 4, 6, and 7 as
obvious in view of Voegel and Kamata is affirmed.

SUMMARY
For the foregoing reasons, the obviousness rejection of claim 1, and
dependent claims 4, 6, and 7 is affirmed.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
4, 6 102(b) Voegel 4, 6
4, 6 103(a) Voegel 4, 6
4, 6, 7 103(a) Voegel, Kamata 4, 6, 7
Overall
Outcome
4, 6, 7

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED