Ex Parte JIA

Patent Trial and Appeal Board

Oct 20, 2016

11279925 (P.T.A.B. Oct. 20, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111279,925 04/17/2006 QiJIA
500 7590 10/20/2016
SEED INTELLECTUAL PROPERTY LAW GROUP LLP
701 FIFTH A VE
SUITE 5400
SEATTLE, WA 98104
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.
920104.404Dl 8979
EXAMINER
WANG, SHENGTIJN
ART UNIT PAPER NUMBER
1627
MAILDATE DELIVERY MODE
10/20/2016 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 QI JIA1
Appeal2014-004742
Application 11/279,925
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON REQUEST FOR REHARING
Appellant filed a Request for Rehearing ("Request") under 37 C.F.R.
§ 41.52 for our Decision mailed May 11, 2016, in which we affirmed the
Examiner's rejection of claims 1, 7, and 10-21 as obvious.
Appellant asserts the decision was in error because the Board
"misapprehended or overlooked certain arguments and factual evidence"
presented in the Appeal and Reply Brief. Req. Reh'g 2. We have
considered the arguments presented by Appellant and are persuaded that we
overlooked certain arguments. As such, we grant Appellant's Request for
Rehearing and modify our opinion to reflect consideration of Appellant's
1 Appellant identifies the Real Party in Interest as Unigen Pharmaceuticals,
Inc. Appeal Br. 2.
Appeal2014-004742
Application 11/279,925
arguments. Our consideration of the arguments that were overlooked does
not change our decision to affirm the Examiner's rejection based on
35 U.S.C. § 103(a).
STATEMENT OF THE CASE
The invention relates to compositions containing mixtures of
Scutellaria and Acacia plant extracts. Spec. 55. The compositions are
useful in treating "joint discomfort and pain associated with conditions such
as osteoarthritis, rheumatoid arthritis, and other injuries that result from
overuse." Id. at 1. Of particular interest are mixtures where the Scutellaria
extract contains baicalin and the Acacia extract contains catechin or
epicatechin. Id. at 55.
Claims 1, 7, and 10-21 are on appeal. Claim 1 is illustrative and
reads as follows:
1. A composition comprised of a
mixture of an extract derived from Scutellaria
enriched for Free-B-ring flavonoids containing
baicalin and an extract derived from Acacia
enriched for flavans containing catechin or
epicatechin.
Appeal Br. 22 (Claims Appendix).
The claims stand rejected as follows:
Claims 1, 7, and 10-21 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Rosenbloom, US 6,555,573 B2 (issued Apr. 29, 2003)
("Rosenbloom") in view of Kubo et al., Studies on Scutellariae Radix. VII.
Anti-arthritic and Anti-inflammatory Actions of Methanolic Extract and
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Flavonoid Components from Scutellariae Radix, 32 Chem. Phann. Bull.
2724--2729 (1984) ("Kubo") and Marti et al., US 4,515,804 (issued May 7,
1985) ("Marti").
DISCUSSION
Issue
The Examiner has rejected claims 1, 7, and 10-21under35 U.S.C
§ 103(a) as unpatentable over Rosenbloom in view of Kubo and Marti. The
Examiner finds that Rosenbloom discloses compositions containing
wogonin, baicalein, and catechin. Final Act. 5. The Examiner finds that
Kubo teaches that Scutellaria extracts contain baicalin, baicalein, and
wogonin. Final Act. 6. The Examiner finds that Marti teaches that catechin
is contained in Acacia extracts. Id. The Examiner goes on to find that
"[t]herefore, it would have been prima facie obvious to a person of ordinary
skill in the art, at the time the claimed the invention was made, to make use
the extract of Scutellariae as the source of wogonin and the extract of Acacia
catechu as the source of catechin in the composition." Id.
Appellant contends that the cited references do not teach the
combination recited in the claims. Appeal Br. 16. Appellant also argues
that the references do not teach the use of enriched extracts as called for in
the claims. Id. Appellant also argues that the Examiner failed to adequately
explain why one of ordinary skill in the art would combine the teachings of
the references to create the claimed composition. Id. With respect to claims
14 and 15 Appellant argues that Rosenbloom does not teach the recited
ratios of extracts. Appeal Br. 17. Appellant also urges that since claim 3,
which recites a specific ratio of extracts, was deemed allowable if rewritten
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Application 11/279,925
in independent form, claims 14 and 15 should also be allowed. Id. Finally,
Appellant points to the Declaration of Dr. Jia as containing evidence of non-
obviousness in that it shows an unexpected synergistic effect of combining
the recited extracts. Appeal Br. 17-18.
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that claims are obvious in
view of Rosenbloom in combination with Kubo and Marti as defined by
35 U.S.C. § 103(a).
Findings of Fact
FF 1. Rosenbloom teaches a composition for the topical treatment of
diabetic neuropathy comprising flavonoids and an antioxidant such as
catechin. Rosenbloom col 3, 11. 24--29; col. 4, 11. 35-39; col 5, 11. 38-52.
FF2. Among the flavonoids disclosed in Rosenbloom are wogonin
and baicalein. Rosenbloom col. 4, 11. 4 7 and 66.
FF3. Rosenbloom teaches that flavonoids have anti-inflammatory
properties. Rosenbloom col. 5, 11. 11-14.
FF4. Catechin is a flavan. Marti col. 1, 11. 10-30.
FF5. Kubo discloses a 70% methanol extract of Scutellariae radix
which contains baicalin, wogonin and baicalein as major components. Kubo
2724.
FF6. Kubo teaches that extracts containing baicalin, wogonin, and
baicalein exhibit anti-inflammatory properties. Kubo 2728.
FF7. Marti discloses that catechin is contained in extracts of Acacia
catechu. Marti col. 1, 11. 29--42.
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FF8. Marti teaches the preparation of pure catechin from the "wooden
parts of Acacia catechu with hot water, evaporating the extract and purifying
the resulting residue ... further by recrystallization from water and drying
the crystals." Id.
FF9. Marti discloses that catechin is an astringent. Marti col. 1, 1. 40.
FF 10. The instant Specification discloses initial Scutellariae extracts
as containing from 0.1 % flavonoids to 24.5 % flavonoids. Spec. 55, Table
10.
FF 11. The instant Specification discloses initial extracts of Acacia
having from 0.2% to 14.8 % flavans. Spec. 53, Table 8.
Principles of Law
"[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification." In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000).
"[T]he test of obviousness is not express suggestion of the claimed
invention in any or all of the references but rather what the references taken
collectively would suggest to those of ordinary skill in the art presumed to
be familiar with them." In re Rosselet, 347 F.2d 847, 851 (CCPA 1965)
(emphasis in original).
"A prima facie case of obviousness typically exists when the ranges
of a claimed composition overlap the ranges disclosed in the prior art." In re
Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
"Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references. . . . [The reference] must be read, not in
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isolation, but for what it fairly teaches in combination with the prior art as a
whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Synergism is not per se unexpected. See In re Diamond, 360 F.2d
214, 218 (CCP A 1966). "What section 103 requires is 'unexpected
synergism' .. . "(id. at 216 n.7); "we attribute no magic status to synergism
per se since it may be expected or unexpected" (id. at 218).
"It is well established that the objective evidence of nonobviousness
must be commensurate in scope with the claims." In re Lindner, 457 F.2d
506, 508 (CCP A 1972).
"To be particularly probative, evidence of unexpected results must
establish that there is a difference between the results obtained and those of
the closest prior art, and that the difference would not have been expected by
one of ordinary skill in the art at the time of the invention." Bristol-Myers
Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014).
Analysis
Claim 1 is representative of the rejected claims and recites a
composition that contains a mixture of an extract derived from Scutellaria
enriched for Free-B-ring flavonoids containing baicalin, as well as an extract
derived from Acacia enriched for flavans containing catechin or epicatechin.
We agree with the Examiner that the claimed mixture would have been
obvious to one of ordinary skill in the art at the time the invention was made.
Rosenbloom discloses a therapeutic topical mixture that contains both
flavonoids and an antioxidant such as catechin. FF 1. The flavonoids
disclosed in Rosenbloom include Free B-ring flavonoids, specifically
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wogonin and baicalein. FF2. Although Rosenbloom's compounds are not
in the form of the extracts recited in claim 1, Kubo teaches the use of
Scutellaria extracts, which contain wogonin, baicalein, and baicalin, as anti-
inflammatory agents. FF5---6. Marti teaches that catechin is contained in
Acacia extracts. FF7-8. Thus, it would have been obvious for one skilled in
the art to substitute the Scutellaria and Acacia extracts taught by Kubo and
Marti for the flavonoids and flavans used in Rosenbloom. In particular, we
agree with the Examiner that one skilled in the art would have reasoned that
it would have been obvious to combine the extracts of Kubo and Marti
because the extracts contain the active ingredients that Rosenbloom teaches
should be combined for use in treating diabetic neuropathy.
Appellant argues that Rosenbloom lists several preferred compounds,
none of which are Free B-ring flavonoids and that Rosenbloom itself does
not teach the claimed two-component mixture. Appeal Br. 16. We are
unpersuaded. While Rosenbloom teaches a three component mixture, claim
1 uses the transitional term "comprised of' which is open ended. Thus,
claim 1 does not exclude the presence of other compounds such as a nerve
growth factor as taught by Rosenbloom. Next, as the Examiner pointed out,
Rosenbloom teaches the use of Free B-ring flavonoids, including wogonin
and baicalein. FF2. That Rosenbloom does not, by itself, teach the
combination of the extracts as recited in the instant claims does not negate a
finding of obviousness. The missing elements are taught by Kubo and
Marti. FF5-9.
Appellant next argues that the references fail to teach the use of
enriched extracts. Appeal Br. 16. This argument is also not persuasive.
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Appellant has not pointed to any specific definition of the term enriched in
the Specification, but instead relies on the common meaning of the term
which is "having an increased proportion or amount of a desired ingredient."
Appeal Br. 9. Appellant argues that one skilled in the art reading the present
Specification would understand that enriched extracts are those containing
more flavonoids or flavans than a regular extract and that neither Kubo nor
Marti disclose enriched extracts. Reply Br. 5-7.
Appellant argues that mere extraction does not inevitably lead to
concentration or enrichment citing the Board's decision in Ex parte Jia,
Appeal No. 2011-004053 ("Jia"). Appeal Br. 11; Reply Br. 5; Req. Reh'g 2.
We note that the discussion in Jia referenced by Appellant deals with
different references and different statutory provisions and is not controlling
here. Moreover, in the analysis which follows, we use the definition for
enriched put forth by Appellant. We do not equate extraction with
enrichment.
Using Appellant's definition of enriched, one skilled in the art would
see that, the use of methanol, either alone or mixed with water, produces
Free B-ring flavonoid containing extracts that have more than 100 times the
amount of flavonoids than extracts prepared with water alone. Spec. 55,
Table. 10. Thus, using Appellant's definition of enriched as interpreted in
light of the Specification, an alcohol extract is "enriched" when compared to
a water based extract. Kubo teaches the use of a 70% methanol extract like
that listed in table 10. FF5. According to Table 10, such an extract would
have 19.61 % flavonoids whereas a water extract would have only 0.09%
flavonoids. One skilled in the art reading the claims in light of the
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Specification would understand that the 70% methanol extract of Kubo is
enriched vis a vis a water extract.
Appellant argues that the Board engaged in impermissible hindsight in
its analysis of the term enriched. Req. Reh'g 4--5. We disagree. As
discussed above, the Board used the Specification to help construe the
meaning of the term enriched. This is not an impermissible use of hindsight.
Appellant also argues that Rosenbloom does not specifically teach the
use of baicalin, but only wogonin and baicalein. Reply Br. 8-9. Appellant
also points out that the Examiner mistakenly equates wogonin with baicalin.
Id. While we agree with Appellant's points, they do not disturb the
conclusion of obviousness. As shown in Kubo, extracts of Scutellaria
contain baicalin as well as wogonin and baicalein. FF5. Thus, the use of a
Scutellaria extract necessarily contains baicalin.
In the Request, Appellant points out that the Board failed to address
the issue of whether Marti discloses an enriched extract of catechin. Req.
Reh'g 6-7. Appellant argues that Marti does not disclose an enriched
extract of catechin. Req. Reh'g 6-7. We are unpersuaded. As the Examiner
noted, Marti discloses preparation of pure catechin from an extract from
Acacia catechu. FF8. We agree with the Examiner that a pure extract of
catechin meets the definition of an enriched extract. Ans. 5.
Appellant argues that a purified compound is not the same as an
extract. Reply Br. 6. Appellant, however, offers no evidence, other than
attorney argument to support this position. We therefore find this argument
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unpersuasive. "Attorneys' argument is no substitute for evidence."
Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989).
Even if we were to accept Appellant's position that a pure compound
is not an extract, we remain unpersuaded. Marti teaches that the pure
compound is prepared by drying or evaporating an extract from Acacia
catechu. FF8. One skilled in the art would understand that at some point
during the evaporation process there exists an intermediate extract that has
"an increased proportion or amount of' catechin that would be useful for
treating inflammation. Thus, Marti teaches an enriched extract.
Appellant next points to evidence of synergism obtained using the
mixture of the two extracts as evidence of non-obviousness. Appeal Br. 17-
18. The evidence of synergism does not rebut the Examiner's finding of
obviousness. Appellant has offered no specific evidence as to whether the
synergistic effect is unexpected other than to say that it is greater than the
results if the effects were cumulative. No explanation is offered as to why
one would expect the effect to be merely cumulative other than the
assumption by the inventor that it would be cumulative. Jia Deel. 2. 2
("assuming for the sake of argument that the efficacy is additive.") Absent
some evidence as to why the synergistic effect would be unexpected,
synergism alone does not show that the claimed compositions are not
obvious. In re Diamond, 360 F.2d at 218.
In the request, Appellant argues that the board misapprehended the
evidence of synergistic results. Req. Reh' g 8. For the reasons discussed
2 Declaration of Qi Jia, dated Nov. 6, 2006, filed Oct. 19, 2006.
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above, we are not persuaded. Moreover, as discussed below, Appellant's
evidence of unexpected results is not commensurate with the scope of the
claims.
In the Request, Appellant argues that the Board failed to consider all
of the evidence of unexpected results, specifically the discussion at pages 5-
8 of the Jia Declaration. Req. Reh'g 10. The Declaration at pages 5-8
refers to Univestin without identifying which Univestin composition is being
discussed. Jia Deel. 5-8. As noted below, the Declaration identifies at least
two different Univestin compositions, one of which is not within the scope
of the present claims. Since it is unclear which compound is being discussed
at the cited pages, the evidence is unpersuasive.
In addition, we agree with the Examiner that the evidence of
unexpected results is not commensurate with the scope of the claims. The
Declaration only identifies three specific formulations, two containing
Univestin and the other Soliprin. Jia Deel. 2, 9. One Univestin sample uses
extracts from plants other that Scutellariae and Acacia falling outside the
scope of the instant claims. Deel. 2--4. The remaining formulations contain
75.7 % Free B-ring flavonoids and 10.3 % flavans. Spec. 56, Table 11, US
20040220119 Al, Table 103. As discussed above, claim 1 used the term
"enriched" which is not associated with a specific amount and can be read as
embracing amounts of Free B-ring flavonoids as low as 19.61 %. In
addition, only two ratios of flavonoids to flavans are discussed in the
Declaration, 80:20 and 15:85. Claim 1 is silent as to the ratio offlavonoids
3 Jia, US 2004/0220119 Al (published Nov. 4, 2004). Cited in the Jia
Declaration as describing the composition of Soliprin. Jia Deel. 9.
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to flavans. Thus the evidence of synergism is not commensurate with the
scope of the claims. In re Lindner, 457 F.2d at 508.
We also agree with the Examiner that the experiments do not compare
the claimed composition with the closest prior art. The claims and the prior
art both call for extracts from Scutellariae and Acacia. The comparative
examples in the Declaration use extracts from Oroxylum indicum and
Unicaria gambir. Deel. 2--4. Appellant offers no evidence that the extracts
from Oroxylum and Unicaria would be the same as extracts from
Scutellariae and Acacia. Thus, the comparisons in the Jia Declaration do
not compare the claimed invention with the closest prior art.
For the reasons discussed, Appellant does not persuade us that the
Examiner failed to show that the composition recited in claim 1 would have
been obvious. Claims 7, 10-13, and 16-21 fall with claim 1 because they
were not argued separately. 37 C.F.R. § 41.37(c)(iv). Turning to claims 14
and 15, we agree with the Examiner that the ratios recited in the claims are
embraced by the proportions recited in Rosenbloom. Final Act. 6. Even
assuming, as Appellant points out in the Reply Brief (Reply Br. 9, n.13), that
the correct amounts of flavonoids and flavans recited in Rosenbloom are
0.002% to 0.04% for flavonoids and 0.001 % to 0.05% for flavans, these
values encompass ratios that fall within the 85: 15 to 20:80 range recited in
claim 14.
Appellant argues that since the Examiner has indicated that claim 3
would be allowed if rewritten in independent form, claims 14 and 15 should
also be allowed. Appeal Br. 17. We do not agree. Claim 3 recites a specific
ratio of 85: 15 which is not taught or suggested by Rosenbloom. Appeal Br.
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22. Claims 14 and 15 recite a range of ratios which encompass the range of
ratios taught in Rosenbloom. While claim 13 may be patentable, claims 14
and 15 are not.
In the Request Appellant argues that the ranges in claims 14 and 15
that the Declaration reports unexpected results for two ratios which fall
within the ranges recited in claims 14 and 15. We are unpersuaded as the
data is not commensurate with the scope of the claims. Appellant has not
shown any persuasive evidence that the unexpected results would be seen
throughout the range including the endpoints.
CONCLUSION
We have considered the arguments raised by Appellant in the
Request, but find none of them persuasive that our original Decision
overlooked any points raised by Appellant resulting in error. We have
reconsidered our Decision but decline to grant the relief requested. This
decision on Appellant's "Request for Rehearing" is deemed to incorporate
our earlier Decision by reference. See 37 C.F.R. § 41.52(a)(l).
DECISION
We have granted Appellant's request to the extent that we have
reconsidered our Decision and modified the Decision to clarify our rationale
for affirming the Examiner's rejections. However, we deny the request with
respect to making any changes to the outcome of the decision. We thus
reiterate that that the Examiner's decision rejecting claims 1, 7, and 10-21
under 35 U.S.C. § 103(a) as unpatentable over Rosenbloom in view of Kubo
and Marti remains AFFIRMED.
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Requests for extensions of time are governed by 37 C.F.R. § 41.52(b).
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
REHEARING GRANTED-IN-PART
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