Ex Parte Yang et al

Patent Trials and Appeals Board

Mar 25, 2019

14002809 - (D) (P.T.A.B. Mar. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/002,809 11/13/2013
23413 7590 03/27/2019
CANTOR COLBURN LLP
20 Church Street
22nd Floor
Hartford, CT 06103
FIRST NAMED INVENTOR
Zhi-hong Yang
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.
YUA0025US 6729
EXAMINER
YOO,SUNJAE
ART UNIT PAPER NUMBER
1626
NOTIFICATION DATE DELIVERY MODE
03/27/2019 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):
usptopatentmail@cantorcolbum.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte ZHI-HONG YANG, HIROKO MIYAHARA,
SHUHEI TAKEMURA, and AKIMASA HATANAKA 1
Appeal2018-002951
Application 14/002,809
Technology Center 1600
Before DONALD E. ADAMS, RYAN H. FLAX, and DAVID COTTA,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims to a method of raising blood adiponectin concentrations, and
lessening TNF-a concentration. The Examiner's rejection of claims 6-8, 12,
and 15-20 under 35 U.S.C. § 103(a) is appealed. 2 We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.
1 The Real Party in Interest is identified as "NIPPON SUISAN KAISHA,
LTD." Appeal Br. 2.
2 Claims 1-5, 9-11, 13, and 14 have been cancelled. Appeal Br. 9-11
(Claims Appendix).
Appeal2018-002951
Application 14/002,809
STATEMENT OF THE CASE
The claimed invention is directed to a treatment for raising blood
adiponectin concentrations and lowering TNF-a concentrations. The
Specification states that "metabolic syndrome amelioration comprises
raising blood adiponectin concentrations, lessening adipocytokine resistin
and TNF-a concentrations, improving insulin tolerance, suppressing
expression of SCD-1 ( stearoyl CoA desaturase-1 ), which is a fatty acid
synthesis system gene in adipose tissue, and lessening the amount of visceral
fat." Spec. ,r 32. The Specification further states that "[t]he metabolic
syndrome ameliorating agent in the present invention is a C22: 1 and/or
C20:1 [monounsaturated fatty acids or MUFAs], or a salt, or ester
comprising these as constituent fatty acids. The metabolic syndrome
ameliorating agent also includes oils derived from natural materials such as
oils of marine products and microorganisms containing these C22: 1 and/ or
C20: 1 [MUFAs], or the salt or the ester." Id. ,r 24; see also id. 9--10
( describing 20 carbon and 22 carbon long-chain monounsaturated fatty acids
(MUF As)). The Specification describes saury raw fish oil, as processed, as
containing a "total weight of MUFA at 50.1 % by weight." Id. ,r 26.
Independent claim 6, reproduced below, is representative:
6. A method of ra1smg blood adiponectin
concentrations, and lessening TNF-a concentration comprising
administering, to a patient in need thereof,
an oil comprising an effective amount of at least one
selected from (a) a monounsaturated fatty acid having 22
carbons, or a salt or an ester thereof, and (b) a monounsaturated
fatty acid having 20 carbons, or a salt or an ester thereof,
wherein total amount of (a) the monounsaturated fatty acid
having 22 carbons, or a salt or ester thereof, and (b) the
2
Appeal2018-002951
Application 14/002,809
monounsaturated fatty acid having 20 carbons, or a salt or an
ester thereof is at least 5 0% by weight of total amount of all fatty
acids present in the oil.
Appeal Br. 9 (Claims Appendix).
The following rejection is on appeal:
Claims 6-8, 12, and 15-20 stand rejected under 35 U.S.C. § 103(a)
over Lindqvist3 and Neschen. 4 Final Action 3.
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability.
[ Only once] that burden is met, [does] the burden of coming forward with
evidence or argument shift[] to the applicant." In re Oetiker, 977 F.2d 1443,
1445 (Fed. Cir. 1992).
"The combination of familiar elements [ or steps] according to known
methods is likely to be obvious when it does no more than yield predictable
results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). However,
"obviousness requires a suggestion of all limitations in a claim." CFMT,
Inc. v. Yieldupint'l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (citing In re
Royka, 490 F.2d 981,985 (CCPA 1974). "Even when obviousness is based
on a single prior art reference, there must be a showing of a suggestion or
3 H. Lindqvist et al., Influence of Herring (Clupea harengus) and Herring
Fractions on Metabolic Status in Rats Fed a High Energy Diet, 196 ACTA
PHYSIOL. 303-14 (2009) ("Lindqvist").
4 S. Neschen et al., Fish Oil Regulates Adiponectin Secretion by a
Peroxisome Proliferator-Activated Receptor-Gamma-Dependent Mechanism
in Mice, 55(4) Diabetes 924--28, abstract (2006) ("Neschen").
3
Appeal2018-002951
Application 14/002,809
motivation to modify the teachings of that reference." In re Kotzab, 217
F.3d 1365, 1370 (Fed. Cir. 2000).
"[W]here the general conditions of a claim are disclosed in the
prior art, it is not inventive to discover the optimum or workable
ranges by routine experimentation." [In re] Aller, 220 F.2d
[824,] [] 456 [(CCPA 1955)]. [However,] [t]his rule is limited to
cases in which the optimized variable is a "result-effective
variable." In re Antonie, 559 F.2d 618, 620 (CCPA 1977).
In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012).
The Examiner determined that Lindqvist disclosed administering
herring oil, that herring oil contains about 40% monounsaturated fatty acids
in the form of gadoleic acid and cetoleic acid, and that administering the oil
to animals resulted in blood adiponectin increases. Final Action 3.
Although the Examiner acknowledged that Lindqvist did not disclose the
claimed 50% MUFA in oil, the Examiner cited Neschen as teaching that
upon administering menhaden fish oil (to mice), the plasma adiponectin
concentration was dose-dependent. Id. Thus, the Examiner reasoned that it
would have been obvious for the skilled artisan to optimize Lindquist's dose
ofMUFA (as a purified and isolated agent) to reach the claimed 50%
amount present in the administered oil.
Appellants argue that the Examiner's rationale for optimizing the
MUF As disclosed by Lindquist to add 10% more thereof to its administered
oil is in error. Appeal Br. 6. Appellants argue Lindqvist does not identify
what components of its disclosed fish oil, or combination of components,
could be expected to cause an increase in blood adiponectin concentrations.
Id. Relatedly, Appellants argue that, because "the amount of
monounsaturated fatty acids has not been recognized as a result-effective
4
Appeal2018-002951
Application 14/002,809
variable in cited references (Lindqvist and Neschen), a person ordinarily
skilled in the art does not have any motivation to optimize the amount of the
monounsaturated fatty acids." Id. at 7 (italics removed).
Appellants' argument is persuasive. Lindqvist is, at best, vague
regarding how gadoleic acid and cetoleic acid (the MUFAs in herring oil)
might effect a patient's biology. See generally Lindqvist. Although these
MUFAs are included in herring oil, it is not clear from either Lindqvist's or
Neschen's disclosures that these fatty acids, specifically, have any biological
effect relative to, in addition to, or synergistically with the other components
of herring oil (e.g., eicosapentaenoic acid, docosahexaenoic acid, and other,
non-fatty acid components). It is also not clear from Lindqvist's disclosure
that gadoleic and cetoleic fatty acid-containing herring oil produces any
increase in adiponectin because, even in view of the difference in the
numbers provided in Lindqvist's Table 6, Lindqvist expressly states,
"adiponectin and blood pressure did not differ between groups." Lindqvist
310. Moreover, Neschen may disclose that fish oil feeding raises
adiponectin concentrations in a dose-dependent manner, but this does not
suggest that any particular component of fish oil, and we know from the
Examiner-cited potions of Lindqvist that there are several, specifically
matters for such results. See Neschen. Thus, we agree with Appellants that
there is no indication in the cited prior art that MUF A concentration (% by
weight in oil) is a result effective optimizable variable, nor is there any
evidence that the skilled artisan would have been motivated to increase the
% by weight ofMUFAs in Lindqvist's herring oil composition.
5
Appeal2018-002951
Application 14/002,809
For the above reasons we conclude that the Examiner has not
established a prima facie case that the appealed claims would have been
obvious over Lindqvist and Neschen. 5
SUMMARY
The obviousness rejection is reversed.
REVERSED
5 Although it was not argued by Appellants, we also note that the claims
require "an oil comprising an effective amount" for "lessening TNF-a
concentration." Although, based on the rationale presented in the final
rejection and Appellants' arguments there-over, the claimed increasing
adiponectin concentrations is the claim element of focus on appeal, the
Examiner's rejection and rationale there-for fails to mention the additional
claim element relating to TNF-a concentration. See Final Action 3--4. As
noted supra, "obviousness requires a suggestion of all limitations in a
claim." CFMT, 349 F.3d at 1342.
6