Ex Parte Suga et al

Patent Trial and Appeal Board

Jul 22, 2016

10692684 (P.T.A.B. Jul. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
10/692,684 10/27/2003 Tetsuya Suga
22850 7590 07/26/2016
OBLON, MCCLELLAND, MAIER & NEUSTADT, LLP,
1940 DUKE STREET
ALEXANDRIA, VA 22314
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.
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EXAMINER
BRANSON, DANIELL
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
07/26/2016 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TETSUY A SUGA, YOSHIAKI OGASAWARA,
YUTARO KANEKO, MASATOSHI KAJIURA, and YASUYO SUGA
Appeal2013-008009
Application 10/692,684
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
PAULRAJ, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1under35 U.S.C. § 134 involving claims to a process
for producing superfine particles from a B-glucan derived from a water
extract of a mushroom. The Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Ajinomoto Co., Inc. (See
Appeal Br. 1).
Appeal2013-008009
Application 10/692,684
STATEMENT OF THE CASE
Background
According to the Specification, "[t]he present invention relates to an
immune activator composition containing either B-glucan or a component
derived from a mushroom." Spec. 1: 14-15.
The Specification discloses that "[t]he present invention is based, in
part, on the inventor's discovery that the various components in
conventional products obtained from mushrooms were not sufficiently
absorbed into animal bodies, and were thus not so utilized as to be expected
in the bodies," and that
when components derived from a mushroom, particularly an
extract of a mushroom with water, preferably an extract thereof
with hot water, were further finely pulverized to prepare
superfine particles and dispersed, for example in water such that
an average particle diameter of the superfine particles was 10
µm or less, more preferably 1 µm or less, still more preferably
0.01 to 1 µmin a micellar state, incorporation thereof through
mucosa was significantly improved, and as a result, immune
functions could be activated or regulated.
Spec. 5: 13-22. Furthermore, the Specification discloses that the type of
mushrooms used for the claimed process include any type of edible
mushrooms, such as Agaricus blazei. Spec. 18-19.
The Claims
Claims 36, 39--42, 44--46, and 91-94 are under appeal, and are
reproduced in the Claims Appendix of the Appeal Brief. Independent claim
36 is representative and read as follows:
36. A process for producing superfine particles comprising
superfine pulverizing a B-glucan derived from a water extract of a
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mushroom, wherein the superfine particles have an average particle
diameter of 10 µm or less, as determined in the form of a dispersion in
water, wherein said superfine pulverizing includes preparing particles
having an average particle diameter of 10 µm or less by mixing a
dispersant with an aqueous solution containing said B-glucan derived
from said water extract of a mushroom.
Appeal Br., Claims App'x, i.
The Re} ection
The Examiner has rejected the claims under 35 U.S.C. § 103(a) as
being unpatentable over the combination ofUchiyama,2 Miyabayashi,3
Kropf, 4 and Desai 5 as evidenced by Dong6 and Shen. 7
FINDINGS OF FACT
We adopt the Examiner's findings of fact, as set forth in the Non-
Final Office Action dated February 16, 2012 ("Non-Final Act."). We add
the following for emphasis:
2 Uchiyama et al., US 2002/0119164 Al, published Aug. 29, 2002
("Uchiyama").
3 Miyabayashi et al., JP l l-262370A, published Sept. 28, 1999
("Miyabayashi").
4 Kropf et al., US 6,858,214 Bl, issued February 22, 2005 ("Kropf').
5 Desai et al., Gastrointestinal Uptake of Biodegradable Microparticles:
Effect of Particle Size, 13 Pharmaceutical Research 183 8-1845 ( 1996)
("Desai").
6 Dong et al., Structural characterization of a water-soluble fJ-D-glucan from
fruiting bodies of Agaricus blazei Murr, 337 Carbohydrate Research 1417-
1421 (2002) ("Dong").
7 Shen et al., Potentiation of intestinal immunity by micellary mushroom
extracts, 28 Biomedical Research 71-77 (2007) ("Shen").
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Application 10/692,684
FFl. Uchiyama teaches that "Agaricus blazei in whole,
particulate, or extracted form, are useful as a barrier when applied to the
skin against harmful effects of environmental toxins, pollution,
chemicals, and radiation," and "[t]aken internally, whole, particulate, or
extracted Agaricus blazei offer protection from various disorders."
Uchiyama, Abstract.
FF2. Uchiyama teaches that "A. blazei can be used fresh or
dried, and are extracted with a water or aqueous solution for use in the
invention," wherein "certain components are solubilized by any aqueous
solvent" and "[t]he temperature of the aqueous solution can be varied to
alter the amount or type of components extracted, but is preferably
between about 26° C. and boiling (about 100° C.")." Id. iJ 32. Uchiyama
teaches a process of hot water extraction followed by "gel permeation
and purification with affinity chromatography." Id. iJ 33.
FF3. Uchiyama teaches "[i]dentified compounds that have
been extracted from Agaricus blazei include polysaccharide-glucan,"
which "exhibits anti-tumor and blood glucose reduction effects through
actions on, e.g., NK cells, T cells, macrophages and other immune cells,
possibly through regulation of interferon release." Id. iJ 34.
FF4. Dong teaches that hot-water extract of fruiting bodies of
Agaricus blazei "by ethanol precipitation, anion-exchange and gel-
permeation chromatography" contains B-D-glucan. Dong, Abstract.
FF5. Miyabayashi teaches a method of processing a mushroom
suspension including Agaricus blazei suspension with a wet jet mill to
micro-atomize the mushroom suspension to 0.005-0.5 micrometer.
Miyabayashi, iii! 1, 13, 42. Miyabayashi discloses the use of high
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pressure at 10-150 MPa to effectively atomize the particles. Id. iii! 22,
40.
FF6. Miyabayashi teaches that orally administration of the
Agaricus blazei suspension has an anti-cancer effect in mouse model. Id.
ii 65.
FF7. Kropf teaches
the use of nanoscalar water-soluble B-(1,3) glucans, which are
essentially free from B-(1,6) links and have particle diameters
ranging from 10 to 300 nm for producing cosmetic and/or
pharmaceutical preparations. When applied topically, the
especially fine dispersion of the particles, compared to prior art
glucans, facilitates their rapid penetration of both the stratum
comeum of the skin and the keratin fibres of the hair.
Kropf, Abstract.
FF8. Kropf teaches the use of emulsifiers to prevent the nano
particles against agglomeration. Id. at 2:23-27.
FF9. In studying the effect of microparticle size on
gastrointestinal uptake, Desai teaches that "[i]n general, the efficiency of
uptake of 100 nm size particles by the intestinal tissue was 15-250 fold
higher compared to larger size microparticles," that "[t]he efficiency of
uptake was dependent on the type of tissue, such as Peyer' s patch and non
patch as well as on the location of the tissue collected i.e. duodenum or
ileum," and that "[t]his has important implications in designing of
nanoparticle-based oral drug delivery systems." Desai, 1838.
DISCUSSION
The Examiner finds that Uchiyama teaches a hot water extraction
protocol on the mushroom Agaricus blazer at 90 ° C to 100 ° C, wherein the
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Application 10/692,684
resulting extract in particulate form would necessarily contain j3-glucans as
evidenced by Dong. Non-Final Act. 4-5; see also FFl--4. The Examiner
acknowledges that Uchiyama does not teach the requirement of an average
particle diameter of 10 µm or less, but finds that this deficiency is cured by
Miyabayashi, Kropf, and Desai. Non-Final Act. 5; see also FF5-10.
The Examiner therefore asserts that one of ordinary skill in the art
would have found it obvious
to utilize the method of obtaining superfine particles of
Agaricus blazei mushroom as taught by Miyabayashi et al. on
the beta glucan particle water extracts from Agaricus blazei
mushroom taught by Uchiyama et al. because both references
are directed to compositions comprising particles from the same
mushroom that have the same anticancer pharmaceutical effect,
and "[f]urthermore, an ordinarily skilled artisan would have been motivated
to utilize the superfine pulverizing method of Miyabayashi et al. on the
particles of Uchiyama et al. because doing so would have resulted in an
increased delivery of the active to the intestinal tissue and resultant
utilization as taught by Desai et al. and Miyabayashi et al." Non-Final Act.
7. The Examiner further asserts that one of ordinary skill in the art would
have found it obvious "to utilize any of the emulsifiers in Kropf et al.,
including lecithin, in the combined method of Uchiyama et al. and
Miyabayashi et al. in order to prevent the nanoparticle produced in the
combined method from agglomerating, such agglomeration having reduced
the absorption and effectiveness of the composition," and
[f]urthermore, because beta-1,3-glucan is the major component
of yeasts and mushrooms which would have inherently been
contained in the hot water extract of Uchiyama et al. (see Shen
et al. pg 71, col 2, para 3; pg 76, col 1, para 3), one of ordinary
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skill in the art to [sic] would have had an expectation of
successful results in combining these teachings of Kropf et al.
with those of Uchiyama et al.
Id. at 8.
We determine that the Examiner has made a prima facie showing of
obviousness, and that Appellants' secondary considerations evidence is
insufficient to overcome the Examiner's prima facie showing.
Appellants argue that Uchiyama "does not actually disclose or suggest
the use of the water extract disclosed therein as a reasonable starting point
for further modification," nor does Uchiyama "appreciate the benefits in
using the same to prepare particles having an average particle diameter of 10
µm or less by mixing a dispersant." Appeal Br. at 5. Appellants further
assert that Kropf "relates to yeast extracts not mushroom extracts which
makes a substantial difference with respect to the nature and identity of the
B-glucans," and Desai "has no relationship to the [superfine] particles
[recited in the instant claims]." Id. at 6.
We are unpersuaded by these arguments as Appellants do not take
into account Miyabayashi's teaching in which a mushroom suspension,
which may be derived from Agaricus blazei (i.e., the same mushroom taught
by Uchiyama), is atomized into a 0.005-0.5 micrometer particle size, which
falls within the claimed particle diameter range. FF5. Moreover, the
Examiner properly relies upon Desai's teaching insofar as it provides
additional motivation for the skilled artisan to minimize the particle size of
biodegradable particles in order to improve the efficiency of gastrointestinal
uptake. FF9.
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Appellants also argue that that the yeast disclosed by Kropf are devoid
of B-1,6 glucans and that the the only B-glucans derived from the yeast
disclosed by are B-1,3 glucans or B-glucans having both l-73-linked and
l -7 6-linked glucose residues, which are distinct from the B-1, 6 glucans
derived from mushrooms. Appeal Br. 7. Appellants rely upon references
allegedly showing that a) "B-glucans derived from yeast are mostly B-
glucans having B-1,3-linked main chains (partly, having B-1, 6-linked
branched chains (residues)," and b) "B-glucans derived from mushroom has
B-1,6-linked main chains, not B-1,6-linked as a residue." Id. at 8.
Appellants rely upon the second Suga Declaration (dated Sept. 22, 2010), in
which he opines "that the skilled artisan would not modify a disclosure of B-
glucans from mushrooms based on a disclosure of B-glucans from yeast ...
based on the fact that there are various types of B-glucans, and there are
differences in structure between B-glucans derived from mushrooms and B-
glucans derived from yeast." Id.
We are also unpersuaded by this line of argument. The claims do not
specify any particular structure for a "B-glucan derived from mushroom."
There is no dispute that the hot water extract of Agaricus blazei, as taught by
Uchiyama and Miyabayashi, would necessarily contain B-glucans. FF4.
Additionally, the Examiner only relies upon Kropf with respect to its
disclosure of the beneficial use of emulsifiers and other additives, such as
lecithin, to prevent particle agglomeration, and there is no basis to conclude
that that the skilled artisan would have found that benefit as taught by Kropf
to be inapplicable to B-glucan particles extracted from mushrooms. Non-
Final Rej. 6; FF8. Moreover, the Specification not only indicates that the B-
glucan extract may be derived from a variety of mushrooms, including
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Agaricus blazei, it indicates that "it may also be [the] j3-glucan not contained
in a component derived from a mushroom," which includes "13-glucan as a
component derived from e.g. yeast(s) (beer yeast etc.)." Spec. 7, 19.
Appellants' attempt to draw a distinction between 13-glucans derived from
mushrooms and 13-glucans derived from yeast is therefore contradicted by
their own Specification.
We are also unpersuaded by Appellants' assertion, additionally
relying upon the first Suga Declaration (dated Sept. 7, 2000) and the
Okumura Declaration (filed April 21, 2011 ), regarding the criticality of the
claimed particle size and the unexpected nature of the same. Appeal Br. 13.
In particular, Appellants assert that the first Suga Declaration demonstrated
that
when the 13-glucan derived from the water extract of a
mushroom, which forms aggregates in an aqueous solution, is
converted into the superfine particles having an average particle
diameter of 10 µm or less (especially, by mixing with a
dispersant) ... , the resulting product significantly improved
incorporation through mucosa so that immune functions can be
activated or regulated.
Appeal Br. 11. Appellants further rely upon the Okumura Declaration's
conclusion that "anti-tumor effects are not shown when the particle size
becomes too small," and thus "even if the particle size is decreased, the
effects are not necessarily improved, and a correlation between the particle
size and the effects cannot be predicted and would not have been expected."
Id. at 14. Appellants, however, have not demonstrated the results
highlighted in these declarations are commensurate in scope with the
claimed invention, which broadly encompasses any particle size of 10 µm or
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less. See Jn re Lindner, 457 F.2d 506, 508 (CCPA 1972) ("objective
evidence of nonobviousness must be commensurate in scope with the
claims."). Nor have Appellants made a comparison to the closest prior art,
which includes Miyabayashi' s teaching of mushroom extracts having a
particle size within the range of 0.005 to 0.5 µm. See In re Burckel, 592
F.2d 1175, 1179-80 (CCPA 1979) ("A Rule 132 affidavit, to be effective,
must compare the claimed subject matter with the closest prior art.").
Finally, with respect to claims 91-94, Appellants separately argue that
"[a]t no point do any of Uchiyama et al, Kropf et al, and Desai disclose or
suggest fine pulverizing treatment at an emulsifying pressure of at least 800
kgf/cm2, especially when using lecithin as an emulsifier (see Claims 92 and
94)." Appeal Br. 16. Appellants, however, do not take into account
Miyabayashi's teaching that the process of atomization can take place at
pressures of 10-150 MPa (FF5), which the Examiner notes is equal to a
pressure of 102-1530 kgf/cm2. Non-Final Rej. 6.
SUMMARY
We affirm the rejection of claims 36, 39-42, 44--46, and 91-94 under
35 U.S.C. § 103(a) as being unpatentable over Uchiyama, Miyabayashi,
Kropf, and Desai, as evidenced by Dong and Shen.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a).
AFFIRMED
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