Ex Parte WU

Patent Trial and Appeal Board

Aug 31, 2016

12343922 (P.T.A.B. Aug. 31, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/343,922 12/24/2008
2292 7590 09/02/2016
BIRCH STEW ART KOLASCH & BIRCH, LLP
POBOX747
FALLS CHURCH, VA 22040-0747
FIRST NAMED INVENTOR
Rong-Tsun WU
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.
5992-0123PUS 1 5249
EXAMINER
OLSON, ERIC
ART UNIT PAPER NUMBER
1673
NOTIFICATION DATE DELIVERY MODE
09/02/2016 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
following e-mail address( es):
mailroom@bskb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RONG-TSUN WU1
Appeal2014-003135
Application 12/343,922
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and RICHARD J.
SMITH, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to
therapeutic methods, which have been rejected as anticipated and obvious.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The Specification discloses an extract from Polygonum multiflorum in
which "the major component was 2,3,5,4' -tetrahydroxystilbene 2-0-B-D-
glucopyranoside," which is also referred to in the Specification as
1 Appellant identifies the Real Party in Interest as National Yang-Ming
University. (Br. 1.)
Appeal 2014-003135
Application 12/343,922
"compound A." (Spec. 9-10.) Compound A is disclosed to enhance kidney
expression of erythropoietin (Epo ), enhance kidney function, and increase
liver expression of both Epo and hepatocyte growth factor. (Id. at 12-13,
15, 17.) Epo is an erythropoiesis-stimulating agent. (Id. at 2.)
Claims 1-3 and 7-13 are on appeal. Claim 1 is illustrative and reads
as follows:
1. A method for enhancing erythropoietin formation in a subject in need
thereof comprising the step of administering to the subject an effective
amount of a compound of the formula:
HO~.·.-.-.-.-.-.-.-./;. I··········~ - )H
~~--------\\ /
OH en
wherein R is a glycosyl group.
Claims 8, 10, and 12 are also independent and are directed to a
method of enhancing erythropoiesis (claim 8), a method of enhancing kidney
function (claim 10), and a method of enhancing the expression of hepatocyte
growth factor (claim 12), in subjects in need thereof, but are otherwise
identical to claim 1.
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Appeal 2014-003135
Application 12/343,922
The claims stand rejected as follows:
Claims 1, 2, 7, and 10-13 under 35 U.S.C. § 102(b) as anticipated by
Wang,2 as evidenced by Chong3 and Hayat,4 or alternatively under 35 U.S.C.
§ 103(a) as obvious based on Wang, Chong, and Hayat (Ans. 2, 7);
Claims 1-3 and 10-13 under 35 U.S.C. § 102(b) as anticipated by
Kimura, 5 as evidenced by Yazihan6 and Hayat, or alternatively under
35 U.S.C. § 103(a) as obvious based on Kimura, Yazihan, and Hayat (Ans.
4, 8); and
Claims 1-3 and 8-13 under 35 U.S.C. § 102(b) as anticipated by Wu7
as evidenced by Kim8 and Hayat (Ans. 5).
2 R. \"X/ ang et al., Changes in hippocampal S}'napses and learning-memo!}'
abilities in age-increasing rats and effects of tetrahydroxystilbene glucoside
in aged rats, 149 NEUROSCIENCE 739--46 (2007).
3 Zhao Zhong Chong et al., Erythropoietin Requires NF-KB and its Nuclear
Trans location to Prevent Early and Late Apoptotic Neuronal Injury During
/J-Amyloid Toxicity, 2 CURR NEUROVASC RES. 387-99 (2005).
4 Amir Hayat et al., Erythropoietin stimulating agents in the management of
anemia of chronic kidney disease, 2 PATIENT PREFERENCE AND ADHERENCE
195-200 (2008).
5 Yoshiyuki Kimura et al., Effects of Stilbene Components of Roots of
Polygonum ssp. On Liver Injury in Peroxidized Oil-fed Rats, 49 JOURNAL OF
MEDICINAL PLANT RESEARCH 51-54 (1963).
6 Nuran Yazihan et al., Erythropoietin attenuates hydrogen peroxide-
induced damage of hepatocytes, 18 TURK. J. GASTROENTEROL. 239--44
(2007).
7 Wu, US 2005/0042314 Al, published Feb. 24, 2005.
8 Hyun Ki Kim et al., A New Stilbene Glucoside Gallatefrom the Roots of
Polygonum multiflorum, 31 ARCH. PHARM. RES. 1225-29 (2008).
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Appeal 2014-003135
Application 12/343,922
I
The Examiner has rejected claims 1, 2, 7, and 10-13 as anticipated by
Wang, as shown by Chong and Hayat, or as obvious based on these three
references. The Examiner finds that Wang discloses administration of
2,3,5,4' -tetrahydroxystilbene-2-0-B-D-glucoside, or TSG, to reduce age-
related neurodegeneration. (Ans. 2-3.) The Examiner finds that TSG
reversed loss of synapses in the brains of the treated rats, and "[t]his synapse
loss is considered to be a model of cognitive decline in Alzheimer's
disease." (Id. at 3.) The Examiner cites Chong and Hayat as evidence,
respectively, that an Alzheimer's disease patient and a subject in need of
enhanced kidney function are both subjects in need of increased Epo
production. (Id. at 3--4.)
Alternatively, the Examiner concludes that it would have been
obvious to administer TSG to an Alzheimer's disease patient based on
Wang's treatment of an animal model of Alzheimer's disease. (Id. at 7-8.)
We will affirm the rejection of claim 1. Wang discloses treatment of
aged rats with TSG, the same compound referred to as "compound A" in
Appellant's Specification. (Wang 739, abstract.) Wang reports that
administration of TSG resulted in "significant improvement in the leaming-
memory abilities in the water maze tests associated with an increase in the
number of synapses and synaptic vesicles, . . . suggesting that TSG may be
beneficial for the treatment of Alzheimer disease." (Id.) Wang also reports
that in an earlier study, "TSG showed a significant improvement of leaming-
memory abilities and inhibition of amyloid plaque formation in APP
transgenic mice of Alzheimer's disease." (Id. at 739, right col.)
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Chong discloses that Alzheimer's disease involves B-amyloid (AB)
toxicity of neurons and that "EPO is an effective entity at the neuronal
cellular level against AB toxicity." (Chong 387, abstract.) We agree with
the Examiner that Chong shows that the animal models of Alzheimer's
disease that were treated by Wang are therefore subjects in need of enhanced
Epo formation, as recited in claim 1, because Epo is effective against AB
toxicity to neurons in Alzheimer's disease patients.
Appellant argues that "Wang teaches that TSG may be beneficial for
the treatment of Alzheimer disease (AD), whereas Chong teaches that
erythropoietin (EPO) may be effective for AD .... Neither Wang nor Chong
teaches or suggests that administering TSG can certainly enhance EPO
formation." (Br. 6.)
This argument is unpersuasive, because Wang teaches administering
the same compound to subjects that are encompassed by the claim language,
and therefore carries out a process within the scope of claim 1. Although
Wang does not disclose that administering TSG enhances Epo formation, "a
reference may anticipate even when the relevant properties of the thing
disclosed were not appreciated at the time." Abbott Labs. v. Baxter Pharm.
Products, Inc., 471 F.3d 1363, 1367 (Fed. Cir. 2006). "The general
principle that a newly-discovered property of the prior art cannot support a
patent on that same art is not avoided if the patentee explicitly claims that
property." Id. at 1368.
We therefore affirm the rejection of claim 1. Claims 2 and 7 fall with
claim 1. 37 C.F.R. § 41.37( c )(1 )(iv).
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With regard to claims 10 and 12, Appellant argues that the references
do not disclose or suggest the claimed methods because the evidence does
not show that TSG is associated with kidney function or expression of
hepatocyte growth factor. (Br. 8.)
The Examiner cites Hayat as evidence that one of the functions of the
kidney is to produce Epo and concludes that "a subject in need of increased
erythropoietin production is reasonably considered to be a subject in need of
enhanced kidney function." (Ans. 4.) The Examiner states that "[fJor these
reasons, the rats treated by Wang et al. are reasonably considered to be in
need of enhanced hepatocyte growth factor expression, enhanced
erythropoietin formation, and enhanced kidney function." (Id.)
We will affirm the rejection of claim 10. Hayat discloses that "the
kidney is the sole source of erythropoietin (EPO) synthesis in adults."
(Hayat 195.) Since one of the functions of the kidney is to produce Epo, a
subject in need of enhanced Epo formation (claim 1) is also a subject in need
of enhanced kidney function (claim 10). The broadest reasonable
interpretation of claim 10, therefore, includes treatment of a subject in need
of enhanced Epo formation. Because, for the reasons discussed above,
Wang and Chong show that the rats treated with TSG by Wang were
subjects in need of enhanced Epo formation, the evidence provided by Hayat
shows that they were also subjects in need of enhanced kidney function, as
recited in claim 10. Claim 11 falls with claim 10. 37 C.F.R. 41.37(c)(l)(iv).
However, the Examiner has not pointed to evidence in any of the cited
references showing that the Alzheimer's disease model animals treated with
TSG by Wang were subjects in need of enhanced expression ofhepatocyte
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growth factor, as recited in claim 12. Thus, the Examiner has not provided
evidence that the method disclosed by Wang meets the limitations of claim
12, and we therefore reverse the rejection of that claim, as well as dependent
claim 13.
II
The Examiner has rejected claims 1-3 and 10-13 as anticipated by
Kimura, as evidenced by Y azihan and Hayat, or alternatively as obvious
based on Kimura, Y azihan, and Hayat.
The Examiner finds that Kimura discloses that TSG treatment reduced
markers of liver injury in rats fed peroxidized lipids. (Ans. 4.) The
Examiner cites Appellant's Specification as evidence that "various diseases
including liver cirrhosis and fatty liver" can be treated by regulating
expression of hepatocyte growth factor. (Id.)
The Examiner finds that Y azihan discloses that Epo reduces cell death
caused by hydrogen peroxide in a hepatoma cell line, "indicating that a
subject undergoing peroxide-induced liver damage is 'a subject in need' of
enhanced erythropoietin formation" and relies on Hayat as evidence that a
subject in need of enhanced Epo formation is also a subject in need of
enhanced kidney function. (Id. at 5.)
We will affirm the rejection. Kimura discloses "the effects of stilbene
components of the roots of Polygon um spp. on rat liver injury caused by oral
administration of peroxidized com oil." (Kimura 51, right col.) The stilbene
components include TSG. (Id. at 51, abstract (referring to TSG by its
chemical name).) Kimura discloses that TSG inhibited elevation of serum
lipids and transaminases caused by peroxidized com oil. (Id. at 52, right
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col.) Kimura thus discloses "the protective actions of stilbene components
such as piceid and [TSG] against liver injury." (Id. at 54, left col.)
Y azihan discloses a study of the effect of Epo on hydrogen peroxide
(H202)-induced liver damage. (Yazihan 239, Background/aims.) Yazihan
concludes that its "results suggest ... [a] protective role of EPO against
hepatic H202 toxicity" (id. at 243, right col.) and that "[e]rythropoietin
treatment may be considered as a therapeutic agent during oxidative injuries
ofhepatocytes." (Id. at 239, Conclusions.) Yazihan therefore provides
evidence that the rats treated with TSG by Kimura are subjects in need of
enhanced Epo formation, as recited in claim 1.
As with the rejections based on Wang, Hayat shows that subjects in
need of enhanced Epo formation are also subjects in need of enhanced
kidney function, as recited in claim 10, because one of the functions of the
kidney is to produce Epo.
Finally, with regard to claim 12, Appellant's Specification itself
provides evidence that the rats treated by Kimura are subjects in need of
enhanced expression of hepatocyte growth factor. The Specification states
that diseases or disorders treated by regulating the expression of hepatocyte
growth factor include "acute hepatitis, liver cirrhosis, fulminant hepatitis,
fatty liver, surgical treatments for liver transplantation, partial resection and
ischemia." (Spec. 5: 1-3, 10-11.)
Yazihan states that "[h ]igh levels of hydrogen peroxide (H202) are
observed during inflammatory and ischemic states of the liver and usually
lead to cellular dysfunction and cytotoxicity." (Yazihan 239, Background.)
Thus, the rats with liver damage caused by peroxidized com oil that are
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treated with TSG by Kimura are subjects in need of enhanced expression of
hepatocyte growth factor, as recited in claim 12.
As with the rejections based on Wang, Appellant argues that "none of
the cited references teach or suggest administering TSG for enhancing
erythropoietin formation." (Br. 9.)
As previously discussed, however, "a reference may anticipate even
when the relevant properties of the thing disclosed were not appreciated at
the time." Abbott Labs., 471 F.3d at 1367. "The general principle that a
newly-discovered property of the prior art cannot support a patent on that
same art is not avoided if the patentee explicitly claims that property." Id. at
1368. Because Kimura teaches administering the same compound to
subjects that are encompassed by the claim language, it carries out a process
within the scope of claims 1, 10, and 12.
Appellant also argues that
without the teaching of the Applicant's invention, one having
ordinary skill in the art would not be able to conceive that TSG
enhances EPO formation. Similarly, without the teaching of the
Applicant's invention, one having ordinary skill in the art would
not be able to reasonably associate TSG with kidney function and
the expression of hepatocyte growth factor.
(Br. 10.)
While the Examiner relied on Appellant's Specification as evidence
that the rats treated with TSG in Kimura are subjects in need of enhanced
expression of hepatocyte growth factor, we do not agree with Appellant's
position that this reliance was improper. Claims are given their broadest
reasonable interpretation in light of the Specification. In re Hyatt, 211 F .3d
1367, 1372 (Fed. Cir. 2000). Thus, it is proper to refer to the Specification
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in interpreting the claim language. See In re Morris, 127 F.3d 1048, 1054
(Fed. Cir. 1997) ("the PTO applies to the verbiage of the proposed claims
the broadest reasonable meaning ... , taking into account whatever
enlightenment by way of definitions or otherwise that may be afforded by
the written description contained in the applicant's Specification.").
Claims 2 and 3 fall with claim 1, claim 11 falls with claim 10, and
claim 13 falls with claim 12. 37 C.F.R. § 41.37(c)(l)(iv).
III
The Examiner has rejected claims 1-3 and 8-13 as anticipated by Wu
as evidenced by Kim and Hayat. The Examiner finds that Wu discloses
methanol extracts from P. multiflorum Thunb. and Kim provides evidence
that TSG is present in such extracts. (Ans. 5-6.) The Examiner finds that
"Wu furthermore discloses that these extracts can be administered to
subjects in need of proliferation of various cell types including erythrocytes,
(i.e. erythropoiesis) and additionally to treat diseases including" liver
cirrhosis and anemia. (Id. at 6.) The Examiner finds that Appellant's
Specification provides evidence that liver cirrhosis is a disease to be treated
by regulating expression of hepatocyte growth factor and anemia is a disease
benefitting from Epo treatment (and therefore also enhanced Epo formation).
(Id.)
We agree with the Examiner's findings. Wu discloses "extract
products from the root of Polygonum multiflorum Thunb., which have been
proved to be biologically active in promoting the proliferation and/or growth
of hepatocytes and bone marrow cells." (Wu ,-i 53.) Wu's extracts are made
by methanol extraction of P. multiflorum Thunb. root material, optionally
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Application 12/343,922
followed by other extraction steps. (Id. at iii! 54-58, 67-79.) Wu discloses
that its extracts are used to treat a subject in need of erythrocyte proliferation
(a.k.a. erythropoiesis), subjects having liver cirrhosis, and subjects having
anemia. (Id. at iJ 82-84.)
Kim discloses analysis of methanol extracts of P. multiflorum Thunb.
root material. (Kim 1225-1226, Extraction and Isolation.) Kim discloses
that the extracts contained compound 3, which Kim identifies as TSG. (Id.
at 1227, right col.) Kim also discloses that TSG is a known constituent of P.
multiflorum root extracts. (Id. at 1225, abstract.) We agree that Kim
supports a reasonable conclusion that the extracts disclosed by Wu contained
TSG, based on the similarity of the extraction procedures disclosed by Wu
and Kim.
The Examiner notes that Appellant's Specification states that subjects
with liver cirrhosis are subjects in need of enhanced expression of
hepatocyte growth factor and subjects having anemia are subjects in need of
enhanced Epo formation. (Spec. 4:1-5, 5:1-3, 10.) Therefore, we agree
with the Examiner that Wu discloses methods meeting the limitations of
claims 1, 8, and 12. As evidenced by Hayat, Epo formation is one function
of the kidney, and therefore subjects in need of enhanced Epo formation are
also subjects in need of enhanced kidney function, as recited in claim 10.
Appellant argues that the rejection based on Wu is erroneous for the
same reason as the rejection based on Wang. (Br. 11.) This argument is
unpersuasive for the reasons previously discussed.
Appellant also argues that "Kim clearly discloses that various
compounds, not only TSG, are present in the methanol extract of Polygonum
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Application 12/343,922
multiflorum. Therefore, the Office has failed to provide any reasonable
support for position that TSG is the active component." (Id.) Similarly,
Appellant argues that "the Office fails to afford a reasonable support for that
it must be the TSG which acts in Wu's extract as an active component
responsible for the observed effects, even in view of the disclosure of Kim."
(Id. at 12.)
This argument is also unpersuasive. Kim identifies nine compounds
in its extracts, including compound 3, which is identified as TSG. (Kim
1225, abstract; 1227, right col.) Kim also discloses that extraction with
methanol, followed by ethyl acetate, and separation into six fractions (id. at
1226, left col.), resulted in a fraction containing "compounds 1 (25 mg), 2
(120 mg), 3 (5.3 g), 4 (8 mg), 7 (50 mg), and 8 (49 mg)." (Id. at 1226, left
col.) At 5.3 grams, the amount of compound 3 in the fraction is far greater
than any of the other compounds, which are all present in milligram
quantities. Based on Kim, therefore, it is reasonable to conclude that Wu's
methanol extracts contained TSG "in an effective amount," as recited in the
claims.
Finally, Appellant argues that "[ n Jo prior art teaches that compounds
for promoting the proliferation of hepatocytes and bone marrow cells must
be useful for enhancing erythropoietin formation, erythropoiesis, kidney
function or expression of hepatocyte growth factor." (Br. 12.)
This argument fails for reasons similar to those discussed above. The
anticipation issue turns on whether Wu discloses administering the same
compound, to the same subjects, in the amount recited in the claims. For the
reasons discussed previously, we conclude that it does. The fact that the
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claims recite effects of carrying out the prior art process that were not
disclosed in the prior art does not render the claimed methods different from
those disclosed by Wu. See Perricone v. Medicis Pharm. Corp., 432 F.3d
1368, 1377 (Fed. Cir. 2005) ("In some cases, [an] inherent property
corresponds to a claimed new benefit or characteristic of an invention
otherwise in the prior art. In those cases, the new realization alone does not
render the old invention patentable.").
Claims 2 and 3 fall with claim 1, claim 9 falls with claim 8, claim 11
falls with claim 10, and claim 13 falls with claim 12. 37 C.F.R.
§ 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 1, 2, 7, 10, and 11 under 35 U.S.C.
§ 102(b) as anticipated by Wang, as evidenced by Chong and Hayat.
Because anticipation is the epitome of obviousness, In re McDaniel, 293
F.3d 1379, 1385 (Fed. Cir. 2002), we also affirm the alternative rejection of
these claims under 35 U.S.C. § 103(a). We reverse both of these rejections
with respect to claims 12 and 13.
We affirm the rejection of claims 1-3 and 10-13 under 35 U.S.C.
§ 102(b) as anticipated by Kimura, as evidenced by Y azihan and Hayat.
Because anticipation is the epitome of obviousness, 293 F.3d at 1385, we
also affirm the alternative rejection of these claims under 35 U.S.C.
§ 103(a).
We affirm the rejection of claims 1-3 and 8-13 under 35 U.S.C.
§ 102(b) as anticipated by Wu, as evidenced by Kim and Hayat.
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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. § l.136(a).
AFFIRMED
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