Ex Parte Kim et al

Patent Trial and Appeal Board

Jul 31, 2018

13882715 (P.T.A.B. Jul. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/882,715 06/21/2013
28997 7590 08/02/2018
HARNESS, DICKEY, & PIERCE, P.L.C
7700 Bonhomme, Suite 400
ST. LOUIS, MO 63105
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Y ong-Chul Kim
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.
6680L-000049-US-NP 8943
EXAMINER
RODRIGUEZ, RAYNA B
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
08/02/2018 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):
stldocket@hdp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YONG-CHUL, ZEE YONG PARK, and JUNG HYUN HAN
Appeal2017-008128
Application 13/882,715
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and JOHN G. NEW,
Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the
claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
Appeal2017-008128
Application 13/882,715
STATEMENT OF CASE
The following claim is representative.
10. A method for treating atopic dermatitis, comprising:
orally administering to a subject in need thereof a therapeutically effective
amount of a pharmaceutical composition comprising chlorophyll a and a
pharmaceutically acceptable carrier.
Cited References
Chien
Ogaki
US 2008/0003303 Al
JP 2009/091349
Jan.3,2008
Apr. 30, 2009
Leung, Donald Y.M., New insights into atopic dermatitis, The Journal of
Clinical Investigation, Vol. 113, No. 5, pp. 651---657, 2004
An, Hyo-Jin et al., Effect of chlorella vulgaris on immune-enhancement and
Cytokine, Production in vivo and in vitro, Food Science and Biotechnology,
Vol. 17, No. 5, pp. 953-958, 2008.
Salama, et al., Effect of ultraviolet radiation on chlorophyll, carotenoid,
protein and praline contents of some annual desert plants," Saudi J. Biol.
Sci., Vol. 18, No 1, pp. 79-86, 2011.
Grounds of Rejection
Claims 10 and 13-16 stand rejected underpre-AIA 35 U.S.C. §I03(a)
as being unpatentable over Ogaki in view of An, and Leung.
Claims 17-19 are rejected under pre-AIA 35 U.S.C. § I03(a) as being
unpatentable over Ogaki, in view of An, Leung and Chien.
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Application 13/882,715
FACTS
The Examiner's findings of fact are set forth in the Final Action at
pages 2-18.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F .2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"[O]bviousness requires a suggestion of all limitations in a claim."
CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
( citing In re Royka, 490 F .2d 981, 985 ( CCP A 197 4) ). When determining
whether a claim is obvious, an Examiner must make "a searching
comparison of the claimed invention - including all its limitations - with the
teachings of the prior art." In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir.
1995).
Obviousness Rejection
The Examiner finds that
Ogaki et al teach external skin preparations containing
chlorella extract ([0001] and claim 1 ); chlorella is classified as a green
algae and contains chlorophyll, protein, a vitamin, a mineral, and
dietary fiber [0002]; and chlorophyll is the critical component of
chlorella, and is thought to be effective in maintenance and
improvement of health [0002]. Ogaki et al teach the chlorella extract
contained in the skin external preparations may contain chlorophyll or
a chlorophyll analog, including chlorophyll A depicted in formula 1
([0027].
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Ans. 4. The Examiner further finds that
Ogaki et al teach external compositions containing a chlorella extract
comprising chlorophyll or a chlorophyll analog are useful for the
treatment of atopic dermatitis ([0005] and claim 6). Ogaki et al teach
an anti-itch cream comprising a chlorella extract was manufactured
and a test to determine whether there is an improvement of the skin
feel 24 hours after applying to skin was carried out, including 40
patients of atopic dermatitis [0037].
Ans. 5.
The Examiner admits that Ogaki does not teach administering the
composition comprising chlorophyll A orally to treat atopic dermatitis. Ans.
5.
The Examiner relies on An as teaching that
chlorella vulgaris is a freshwater unicellular microscopic alga that is
widely used as a food supplement in Japan; the supplement is taken as
tablets, capsules, extract liquid or as a food additive; claims for health
benefits include improvement of the immune function (page 953, left,
1st paragraph).
Ans. 5---6. According to the Examiner, "Leung et al teach an oral treatment
regimen for allergic dermatitis and suggests that the oral treatment may be
more acceptable to some patients and reach inflammatory targets not
accessible to topical medications (page 656, right, 1st full paragraph)." Ans.
6.
The Examiner concludes that
since Ogaki teaches a method of treating atopic dermatitis comprising
administering a composition comprising chlorophyll A which is
extracted from Chlorella vulgaris; since An teaches Chiarella
vulgaris is widely used as a food supplement taken in the form of
tablets, capsules, extract liquid or as a food additive and is thus
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suitable for oral administration; and since Leung teach a benefit of an
oral treatment regimen for allergic dermatitis includes that the
treatment may be more acceptable to some patients and reach
inflammatory targets not accessible to topical medications, at the time
of the invention it would have been prima facie obvious for a person
of ordinary skill in the art to administer the composition comprising
chlorophyll A extracted from Ch/ore/la vulgaris taught by Ogaki in an
oral formulation with an expectation of success, since the prior art
teaches both routes of administration are suitable for the treatment of
atopic dermatitis.
Ans. 6.
Appellants contend that
Ogaki teaches external application of the chlorella extract, e.g.,
cosmetics (see paragraphs [0004], [0006], [0007], [0009] and Claims
1-12 of Ogaki). Regardless of the residual amount of chlorophyll a in
the composition, it would be only relevant to dermal application, not
to a therapeutically effective amount for oral administration.
Reply Br. 2. Appellants argue that
the extraction process described in Ogaki would actively reduce the
amount of chlorophyll a in the chlorella extract. The extraction
process disclosed in the working examples utilizes UV irradiation
(paragraph [0037]). UV exposure decomposes the chlorophyll a
in the cultured chlorella cells into pheophorbide without affecting
chlorin e-6 (para [0041 ]). Such disclosure agrees with the art. See,
for example, Exhibit B. Salama, et al. (Saudi J. Biol. Sci., 2011 Jan,
18(1 ), 79-86), who demonstrate that chlorophyll a is degraded upon
exposure to UV radiation (Figure 1 ). Thus, the extraction process of
Ogaki stabilizes the chlorin e-6 (paragraph [0015]), increases the
chlorin e-6 content (paragraph [0017]), and decomposes chlorophyll a
(paragraph [0041 ]). One of ordinary skill in the art at the time the
invention was made would recognize that chlorophyll a is being
actively removed from the chlorella extract. Moreover, there is no
reason to expect that chlorophyll a, a component of chlorella that is
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actively decomposed during extraction, would be the active ingredient
for reducing itch in the chlorella extract.
App. Br. 6, emphasis added. Therefore, Appellants contend that the
combination of Ogaki, An and Leung does not teach a therapeutically
effective amount of chlorophyll a. Reply Br. 2.
ANALYSIS
We do not find that the Examiner has provided evidence to support a
prima facie case of obviousness on the evidence before us.
The Examiner admits that Ogaki does not teach oral administration of
chlorella or chlorophyll a to treat atopic dermatitis. Ans. 6. An merely
discloses that chlorella can be administered orally to affect the immune
system, including IFN-y, IL-4, and IL-2. An does not disclose a
therapeutically effective amount of chlorella or chlorophyll a to be
administered orally to treat atopic dermatitis. An does not indicate the
relationship between IFN-y, IL-4, and IL-2 and atopic dermatitis or
alternatively does not disclose a therapeutically effective amount of
chlorophyll a to induce Th 1 immune responses and reverse Th2 immune
responses associated with inflammation, such as allergic inflammation or
atopic dermatitis. See, Final Act. 7.
In addition, with further respect to the issue of whether the cited
references disclose a therapeutically effective amount of chlorophyll a to
treat atopic dermatitis, Appellants argue that according to Salama, the UV
treatment of chlorella as disclosed in Ogaki, would significantly deplete
chlorophyll a in the chlorophyll extract. See, e.g. Salama, Fig. 1, p. 82;
Ogaki ,r 15. Thus, Appellants argue that Ogaki does not disclose a
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therapeutically effective amount of chlorophyll a for the oral treatment of
atopic dermatitis.
While Leung mentions that oral treatment regimens for atopic
dermatitis can be more effective than topical treatment, Leung does not
disclose the treatment of atopic dermatitis with orally administered
chlorohyll a and does not disclose a therapeutically effective amount of
chlorophyll a to treat atopic dermatitis.
Therefore, what is missing from the Examiner's analysis, and from the
cited references, is a suggestion to orally administer chlorophyll a to treat
atopic dermatitis, and an orally effective dose of chlorophyll a to treat atopic
dermatitis. We do not find that the preponderance of the evidence supports
the Examiner's arguments. The obviousness rejection is reversed.
Rejection 2- Obviousness
Claims 17-19 are rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Ogaki, in view of An, Leung and Chien.
The deficiencies of Ogaki, An and Leung are discussed above. Chien
is further relied on by the Examiner for the disclosure that chlorophyll may
be administered orally or topically to reduce inflammation. Ans. 8. While
Chien orally administers a composition comprising chlorophyll a in doses
similar to those claimed, the disclosure of Chien is primarily related to
wound healing and not treating the condition of atopic dermatitis.
Therefore, what is missing from the Examiner's analysis and from the
cited references is a suggestion to orally administer chlorophyll a to treat
atopic dermatitis, and an orally effective dose of chlorophyll a to treat atopic
dermatitis. Chien does not overcome the deficiencies of Ogaki, An and
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Leung, and the combination of references does not teach or suggest each
element claimed. We do not find that the preponderance of the evidence
supports the Examiner's arguments. The obviousness rejection is reversed.
CONCLUSION OF LAW
The cited references do not support the Examiner's obviousness
rejections, which are reversed.
REVERSED
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