Ex Parte Tam et al

Patent Trial and Appeal Board

Apr 9, 2018

14327529 (P.T.A.B. Apr. 9, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/327,529 07/09/2014 YunKau Tam
33729 7590 04/11/2018
LAW OFFICES OF ALBERT WAI-KIT CHAN, PLLC
141-07 20TH A VENUE
WORLD PLAZA, SUITE 604
WHITESTONE, NY 11357
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.
1242-Bl-PCT-US 4861
EXAMINER
HARWARD, SOREN T
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
04/11/2018 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):
chank@kitchanlaw.com
docketing@kitchanlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YUN KAU TAM and JACK ADAM TUSZYNSKI
Appeal2016-005727 1
Application 14/327,529
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
ULRIKE W. JENKS, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to methods for
preparing herbal compositions that contain multiple components. The
Examiner rejected the claims as being indefinite, as failing to further limit
claims from which they depend, and for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b)(l).
We reverse.
1 Appellants state that the "real party in interest is Sinoveda Canada, Inc., the
assignee of the present application." Appeal Br. 3.
Appeal2016-005727
Application 14/327,529
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 31-39, under 35 U.S.C. § 112, second paragraph, as being
indefinite (Final Act. 2-3);
(2) Claims 32 and 33, under 35 U.S.C. § 112, fourth paragraph, as
failing to further limit the subject matter of the claim from which they
depend (id. at 4);
(3) Claims 31-37, under 35 U.S.C. § 103(a) as being unpatentable
over El-Masri, 2 Huang, 3 Chen, 4 Xue, 5 and Li6 (id. at 4--9); and
(4) Claims 36-39, under 35 U.S.C. § 103(a) as being unpatentable
over El-Masri, Huang, Chen, Xue, Li, and Mizuma7 (id. at 10-11).
Claim 31, the only independent claim on appeal, is illustrative, and
reads as follows:
2 Hisham A. El-Masri et al., Integrated Approaches for the Analysis of
Toxicologic Interactions of Chemical Mixtures, 27 Critical Reviews in
Toxicology 175-197 (1997).
3 Xiaodong Huang et al., Strategy for analysis and screening of bioactive
compounds in traditional Chinese medicines, 812 J. Chromatography B 71-
84 (2004).
4 Victoria C.P. Chen et al., A review on design, modeling and applications of
computer experiments, 38 IIE Transactions 273-291 (2006).
5 Ling Xue et al., Identification of a Preferred Set of Molecular Descriptors
for Compound Classification Based on Principal Component Analysis, 39 J.
Chem. Inf. Comput. Sci. 699-704 (1999).
6 H. Li et al., Statistical Learning Approach for Predicting Specific
Pharmacodynamic, Pharmacokinetic, or Toxicological Properties of
Pharmaceutical Agents, 66 Drug Devel. Res. 245-259 (2006).
7 Takashi Mizuma, Kinetic Impact of Presystemic Intestinal Metabolism on
Drug Absorption: Experiment and Data Analysis for the Prediction of In
Vivo Absorption from In Vitro Data, 17 Drug Metab. Pharmacokin. 496-506
(2002).
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Application 14/327,529
31. A method of preparing a herbal composition comprising
multiple components for drug formulations, the method
comprises the steps of:
a) preparing multiple samples of a herbal mixture that
comprises multiple components, each of said
sample comprises the same multiple components
with randomized concentrations, said samples
further comprise multiple doses of the mixture,
wherein the identities of or interactions among the
components are not known a priority;
b) using in vitro assays or in silica methods to obtain
parameters describing the rate of elimination of
said components and their active metabolites in a
plurality of mammalian tissue systems;
c) using in vitro assays or in silica methods to obtain
parameters describing distribution of said
components and their active metabolites in a
plurality of mammalian tissue systems;
d) obtaining pharmacodynamic parameters describing
the response of said samples of mixture;
e) performing Subset-Selection Principal Component
Analysis to reduce dimensionality of the
parameters from (b) to ( d), thereby generating
parameters for active components in the mixture;
t) inputting the parameters for active components
from ( e) into a first modeling system to estimate
optimal weights of the active components, said
modeling system comprises
r wherein r is linearized response, is average
linearized response; w; is weight of the ;th
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Application 14/327,529
component, v.-'l is weight of the non-linear self-
interaction behavior of the ;th component, d; is the
dose of the ;th component, ai and ifi are average
doses of the ith and fh component, and WiJ is the
weight of the interacting pair,
w~ . .l{'~ .• wu is a minimization procedure to minimize
the difference between r and said first modeling
system by varying
wherein said first modeling system generates
outputs comprising (i) optimal weights a; and p;,j,
which are optimal values of w; and "~/1: and WiJ
obtained from said minimization procedure, and
(ii) total dose of the components D, which is
""1~ d . defined as Li.,,'' -i'
g) inputting the optimal weights, a; and p;,j, from ( f)
into a second modeling system that comprises
,(\ .i? ;;:
A,= rt,,+ L:a,x, +· 2=L/1,.Jx,.x"
:LL L~. i .x., '" i
.:~~:· :~ ~:} ~ \,~· i
wherein, A is estimated response generated by said
active components per total dose, ao is an average
linearized response per total dose, x; and Xj are
defined as d';/D and dj/D respectively, which are
fractions of said total dose D contributed by the ith
and/h component respectively, and wherein
max
; is a maximization
procedure achieved by varying Xi, 'Vi is for all i
values, wherein said second modeling system
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Application 14/327,529
generates outputs comprising dosages of active
components that generate maximal response; and
h) using dosages of active components that generate
the maximal response from (g) to prepare a herbal
composition comprising multiple components,
wherein the dosages for said multiple components
are obtained from said dosages of active
components that generate the maximal response.
Appeal Br. 39-41.
INDEFINITENESS
In rejecting claims 31-39 for indefiniteness, the Examiner determines
that the "two limitations of the samples [recited in claim 31] - first, that they
are 'of a herbal mixture that comprises multiple components'; and second,
that they 'comprise[] the same components with randomized concentration'
- are mutually contradictory." Final Act. 3 (brackets in original).
In particular, the Examiner contrasts the natural variation in the
concentrations of the components of an herbal mixture, as described in i-f 84
of the Specification, with synthetic mixtures created by randomly combining
components of herbal mixtures, as described i-f 96 of the Specification. Id.
The Examiner concludes that "[a Jn 'herbal mixture' is inherently from
a 'natural source' and a 'botanical source', and cannot be from a 'synthetic
source'. Id.
Appellants contend that, reading the claims in light of the
Specification, a skilled artisan would have understood that "that one can
obtain an herbal mixture either from natural sources or from synthetic
sources. With regard to the source of the herbal mixture of claim 31, the
present specification does not restrict an herbal mixture to natural source."
Appeal Br. 9.
We find that Appellants have the better position.
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It is well settled that, during examination, the PTO must interpret
terms in a claim using "the broadest reasonable meaning of the words in
their ordinary usage as they would be understood by one of ordinary skill in
the art, 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." In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997).
As our reviewing court has explained, however, "[a]bsent claim
language carrying a narrow meaning, the PTO should only limit the claim
based on the specification ... when [it] expressly disclaim[s] the broader
definition." In re Bigio, 381F.3d1320, 1325 (Fed. Cir. 2004).
In the present case, the Examiner does not identify in the
Specification, or elsewhere in the record, a specific definition of the term
"herbal mixture" that would exclude a synthetically prepared mixture of
herbal ingredients. Given the absence of such a specific narrowing
definition, the Examiner does not persuade us that claim 31 is internally
contradictory in reciting herbal mixtures in which the concentrations of the
herbal ingredients are randomized.
Accordingly, because the Examiner does not persuade us that claim
31 is internally contradictory, the Examiner does not persuade us that a
skilled artisan would have failed to understand the scope of claim 3 1. We,
therefore, reverse the Examiner's rejection of claim 31, and its dependent
claims, for indefiniteness.
IMPROPER DEPENDENCY
The Examiner's rejection of claims 32 and 33 as being of improper
dependent form is based on the Examiner's determination that the term
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"herbal mixture" in claim 31 cannot encompass synthetic mixtures, as
recited in claim 32. Final Act. 4. Therefore, the Examiner reasons, claim
32, and its dependent claim 33, do not further limit claim 31 as required by
35 U.S.C. § 112, fourth paragraph. Id.
As discussed above in relation to the Examiner's indefiniteness
rejection, however, the Examiner does not persuade us, on this record, that
an herbal mixture excludes a mixture of herbal ingredients from a synthetic
source. We, therefore, also reverse the Examiner's rejection of claims 32
and 33 under 35 U.S.C. § 112, fourth paragraph.
OBVIOUSNESS
In rejecting claims 31-37 for obviousness, the Examiner finds that El-
Masri describes a process that includes steps (a) through (d) of claim 31, and
also steps (f) through (h) of claim 31, but concedes that El-Masri "does not
teach analysis of an herbal mixture." Final Act. 6.
The Examiner cites Huang as evidence that it was known in the art to
use pharmacodynamic analysis of herbal medicines to identify bioactive
constituents of herbal mixtures. Id.
The Examiner cites Chen as evidence that "when designing
experiments to obtain data for RSM fitting [as taught in El-Masri], a more
efficient approach than a full factorial design is sampling a Latin Hypercube
(p. 279 § 4.3), in which points of the parameter space (i.e. the component
concentrations) are sampled at random." Id. at 7.
The Examiner concedes that El-Masri "also does not teach
'performing Subset Selection-Principal Components Analysis' [PCA] to
reduce the dimensionality of PK and PD parameters" as recited in step ( e) of
the process of claim 31, and cites Xue and Li as evidence that PCA would
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have been recognized as an efficient approach for use in the modeling
methods of El-Masri. Id.
Based on the references' combined teachings, the Examiner reasons:
An invention would have been obvious to one of ordinary
skill in the art if some teaching or motivation in the prior art
would have led that person to modify prior art references to
arrive at the claimed invention. At the time of invention, said
practitioner would have followed the teachings of Huang, to
identify the pharmacodynamics of constituents of herbal
medicines, and used the pharmacodynamic modeling method of
El-Masri to identify bioactive constituents of the mixtures and
characterize their pharmacodynamics, including the interaction
effects of the various compounds. Given that El-Masri teaches
that the modeling method can be applied to mixtures of any
number of any compounds, said practitioner would have readily
predicted that the modification would successfully result in a
method that identifies bioactive components of an herbal
medicine, and models the pharmacodynamics of that mixture.
Id. at 8-9.
Appellants contend that the Examiner improperly concludes that the
method recited in claim 31 would have been obvious because:
A) The claimed method satisfies a long felt but unsolved
need in the art;
B) The combination of the cited references does not teach
or suggest all the limitations recited in the claims; and
C) Combination or routine modification of the cited art
elements would not arrive at the claimed method.
Appeal Br. 10-11.
As to Appellants' contentions regarding long-felt but unsolved need,
the Examiner responds that "[o]ther than Appellant's own unsupported
allegations regarding deficiencies in the art (Brief, pp. 13-15), the only
evidence provided by Appellant to demonstrate 'long felt but unsolved need
in the art' is the abstract of Huang." Ans. 4--5.
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In reply, Appellants note that they "cited Huang as well as relevant
paragraphs from the specification in the Appeal Brief (see p.13-15 of Appeal
Brief). The citation includes many publications which are objective
evidence in the art." Reply Br. 7. Appellants contend that the Examiner
"ignored these publications [cited in the Specification] and did not justify
why these publications could not support the long-felt but unsolved need;
instead, the Examiner exclusively looked at Huang." Id.
Moreover, Appellants contend:
On p.16, last paragraph of the Appeal Brief, Appellant
summarized how the claimed method has been empirically
proven to be able to solve the existing problems in the art.
Importantly, what the claimed method solves is not only the
problems with the discovery of TCM [traditional Chinese
medicine], but also the production of TCM products that are
effective and consistent in quality and efficacy.
Therefore, absent any evidence or reasoned explanation,
the Examiner's assertions regarding the "long-felt but unsolved
need" are general and unsubstantiated statements and hence are
not persuasive.
Id. at 8; see also Appeal Br. 16 (citing Examples 10 and 12 from the
Specification as evidence that "the claimed method has been empirically
proven to be able to solve the present problems").
We find that Appellants have the better position.
As our reviewing court has explained "all evidence of nonobviousness
must be considered when assessing patentability." In re Soni, 54 F.3d 746,
750 (Fed. Cir. 1995) (emphasis added); accord In re Sullivan, 498 F.3d
1345, 1353 (Fed. Cir. 2007).
Thus, before the ultimate conclusion of obviousness can be made, all
evidence of "long-felt but unresolved needs" must be considered. In re
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Sullivan, 498 F.3d at 1351 (citing WMS Gaming, Inc. v. Int'! Game Tech.,
184 F.3d 1339, 1359 (Fed. Cir. 1999).
In the present case, as Appellants contend, contrary to the Examiner's
assertion that the Huang abstract was the only evidence cited regarding long-
felt but unsolved need (see Ans. 4--5), Appellants cite i-fi-16, 9, 10, and 15 of
the Specification in support of those arguments (Appeal Br. 13-15), and
i-fi-16, 9, and 10 in tum cite a number of publications purporting to establish a
need for further characterization of herbal preparations (see Spec. i-fi-16, 9,
and 10; see also id. at pp. 75-85 (list of references cited in Specification)).
In addition, as noted above, Appellants cite Examples 10 and 12 from the
Specification as evidence "that the claimed method has been empirically
proven to be able to solve the present problems." Appeal Br. 16.
Because the Examiner did not consider all of the evidence advanced
by Appellants to show nonobviousness, the Examiner's ultimate conclusion
as to the question of obviousness cannot be sustained. See In re Kao, 639
F.3d 1057, 1067 (Fed. Cir. 2011) ("[W]hen secondary considerations are
present, though they are not always dispositive, it is error not to consider
them."); accord, Sullivan, 498 F.3d at 1353. We, therefore, reverse the
Examiner's obviousness rejection of claims 31-37 over El-Masri, Huang,
Chen, Xue, and Li.
In rejecting claims 36-39 for obviousness over El-Masri, Huang,
Chen, Xue, Li, and Mizuma, the Examiner cited Mizuma as evidence that
the methods recited in dependent claims 36-39 would have been obvious
variations of the methods suggested by the combined teachings of El-Masri,
Huang, Chen, Xue, and Li, discussed above. Final Act. 10-11. Because the
Examiner does not assert, nor do we discern, how the addition of Mizuma to
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the other references remedies the deficiencies, discussed above, as to the
Examiner's ultimate conclusion of obviousness, we reverse this rejection as
well.
SUMMARY
For the reasons discussed, we reverse each of the Examiner's
rejections.
REVERSED
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