Ex Parte Zelkha et al

Patent Trial and Appeal Board

Jan 23, 2019

13137061 (P.T.A.B. Jan. 23, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/137,061 07/18/2011
23117 7590 01/25/2019
NIXON & V ANDERHYE, PC
901 NORTH GLEBE ROAD, 11 TH FLOOR
ARLINGTON, VA 22203
FIRST NAMED INVENTOR
Morris Zelkha
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.
GPK-6278-4 8408
EXAMINER
KIM, JENNIFER M
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
01/25/2019 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):
PTOMAIL@nixonvan.com
pair_nixon@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MORRIS ZELKHA, RACHEL LEVY, ESTHER P ARAN,
YOA V SHARON!, and JOSEPH LEVY
Appeal2018-001897
Application 13/137,061 1
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
LA VIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the
Examiner's rejection of claims 1, 15-17, 25, and 26. We have jurisdiction
under 35 U.S.C. § 6(b ). For the reasons set forth below, we AFFIRM.
BACKGROUND
The Specification describes compositions combining polyphenols and
carotenoids, which may be useful in the inhibition of inflammatory
mediators. See Spec. 1.
Claim 1 is illustrative, and recites:
1 Appellants identify Lycored, Ltd., as the real party in interest. Br. 3.
Appeal2018-001897
Application 13/137 ,061
1. A therapeutic composition comprising curcumin, and lutein
and lycopene combined in the following weight ranges:
Lycopene: Lutein: Curcumin,
0.1-1.5: 0.1-1.5: 0.1-1.0.
Br. 11 (Claims Appendix) (some formatting added).
REJECTION MAINTAINED ON APPEAL
Claims 1, 15-17, 25, and 26 stand rejected under 35 U.S.C. § I03(a)
(pre-AIA) as unpatentable over Nishino, 2 Stahl, 3 and Sharoni. 4 Ans. 2.
DISCUSSION
As relevant to illustrative claim 1, the Examiner relies on Nishino as
teaching compositions including, inter alia, lycopene, lutein, and curcumin.
See Final Action 4 ( citing Nishino,r,r 104, 5 105 and Example 1 ). The
Examiner notes that although Example 1 ofNishino provides for lycopene:
lutein: curcumin in a 1: 0.6: 10 ratio (id.), Nishino also discloses that "the
amount of curcumin can be employed approximately 5 to 250 parts by
weight (particularly about 10-100 parts by weight) per 100 parts by weight
2 Nishino et al., US 2004/0116514 Al, published June 17, 2004.
3 Stahl et al., Carotenoid Mixtures Protect Multilamellar Liposomes against
Oxidative Damage: Synergistic Effects of Lycopene and Lutein, 427 FEBS
LETTERS 305 (1998).
4 Sharoni et al, US 2004/0259959 Al, published Dec. 23, 2004.
5 The Examiner cites to paragraph "140" ofNishino rather than paragraph
104, as we have cited here. As Nishino does not include a paragraph 140, we
presume the Examiner meant to cite paragraph 104, which, along with
paragraph 105, constitutes Nishino's Example 1.
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Appeal2018-001897
Application 13/137 ,061
of carotenoid compounds" (id. (citing Nishino ,r 75)). Nishino lists lycopene
and lutein among its examples of carotenoid compounds. See Nishino ,r 48.
Therefore, Nishino's ratio ranges of carotenoids:curcumin overlap with the
ratio ranges of lycopene:lutein:curcumin recited in claim 1. See Final
Action 4. This alone constitutes a prima facie case of obviousness of claim
1. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) ("In cases
involving overlapping ranges, we and our predecessor court have
consistently held that even a slight overlap in range establishes a prima facie
case of obviousness."); see also In re Aller, 220 F.2d 454, 456-58 (CCPA
1955) ("[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."). However, the Examiner further supports the rejection
through reference to Stahl, for the synergistic effect of lycopene and lutein.
See Final Action 5 ( citing Stahl 307, Title). 6 The Examiner finds it would
have been obvious to combine the references by optimizing the amount of
curcumin in Nishino 's Example 1 to curcumin levels within the claimed
range, because it would be a matter of discovering optimal or workable
ranges, well within the abilities of the ordinarily skilled artisan. See id. at 5-
6 ( citing Aller).
Appellants do not dispute the Examiner's specific findings regarding
the individual elements of claim 1. See generally Br. 6-9. Instead,
6 The Examiner also cites to Sharoni, as teaching that lycopene, or lycopene
and additional carotenoids, can enhance the inhibitory effects of phytoene
and phytofluene on mammary cancer cell proliferation. See Final Action 5
( citing Sharoni Abstract, ,r,r 8, 25). These teachings are relevant to certain
dependent claims, which recite phytoene and/or phytofluene.
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Application 13/137 ,061
Appellants assert that their claims embody a previously-unappreciated
insight, i.e., that "curcumin at certain levels ( e.g. as defined by the ratio
between the carotenoids and curcumin) results in a previously entirely
unknown - and previously unexpected - synergistic interaction with
certain carotenoids, leading to unexpectedly high levels of inhibition of the
production of some key anti-inflammatory mediators." Id. at 6. Therefore,
according to Appellants, the teachings of synergism between carotenoids
cited by the Examiner would not have motivated the ordinarily skilled
artisan to optimize curcumin levels to achieve the claimed ranges. See id. at
8; see also id.at 9. In support, Appellants point to Figures 13A, 13B, and 14
of the drawings filed with the Specification, which Appellants assert show a
"marked synergism" when lycopene, lutein, and curcumin are used in
combination, as compared to the additive effect one would expect from
summing the results for each component individually. Id. at 8 ( discussing
Figs. 13A, 13B); see also id. at 9 (discussing Fig. 14).
Having reviewed Appellants' Figures 13A, 13B, and 14, we conclude
that Appellants' proffered evidence of unexpected results are not entitled to
substantial weight. Figure 14 is reproduced below:
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Appeal2018-001897
Application 13/137 ,061
:fig. 14
60·1
i
! 50~
.: 1
:.i 40~
.:.! l .! 30-
CurcuminPC
l 20~
1~]____._ __ ~----···-.---..._L...,._._
Cur-,:;vmml'C ZµM +
LycOmcto 1 µ.M
lutein 1µM
60·
50·
40
+
Pure Curcum in
o +, ...,.J..m.=.,:;i'' :............., _ ___._..__,...--1'""--J--~
Cvr-.::1,ul!tin 2µM
LyeOmcto 1 i.J,1
l U1t,i11 1 µht
+
+
+
+
•
+
s
s
+
+
+
+
+
+
s
s
Figure 14 is a pair of bar graphs demonstrating the percentage of nitrous
oxide (NO) inhibition observed in the presence of curcumin, lycopene, or
lutein alone (first three bars, both graphs), curcumin and lycopene together
(fourth bar, both graphs), and curcumin, lycopene, and lutein together (last
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Appeal2018-001897
Application 13/137 ,061
bar, both graphs). 7 The "S" indicates what Appellants calculate to constitute
synergistic inhibition. See Spec. 50.
As illustrated by (but not limited to) Figure 14 of the Specification,
Appellants' data do not include a comparison with the combination already
known in the prior art as having synergistic effects, i.e., lycopene and lutein
together. See, e.g., Stahl Abstract; Sharoni ,r 8. Nor did Appellants compare
their combination(s) to the composition of Example 1 ofNishino, to show
that claimed ratio had unexpected advantages while the composition of
Nishino having all three components did not. See Ans. 4. Without such a
comparison, a determination cannot be made as to whether the synergistic
effects reported in the Specification and Figures 13A, 13B, and 14 are due to
the combination of lycopene and lutein, to the addition of curcumin to the
already-known-to-be-synergistic lycopene/lutein combination, or, as
Appellants maintain, to the specifically claimed ratios of lycopene: lutein:
curcumin. Thus, we agree with the Examiner's general finding that
Appellants have failed to compare their invention to the closest prior art.
See Ans. 4.
Having considered Appellants' arguments, we are not persuaded of
any reversible error by the Examiner in rejecting claim 1. Appellants do not
separately argue claims 15-17, 25, or 26; these fall with claim 1. See 37
C.F.R. § 4I.37(c)(l)(iv).
7 "Curcumin-PC" is a commercially available curcumin preparation with
improved miscibility. See Spec. 8. "Curcumin" refers to pure curcumin.
See id. at 50. "Lycomato" is a commercially available tomato extract, used
as a source of lutein. See id. at 8, 16.
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Application 13/137 ,061
CONCLUSION
We sustain the Examiner's rejection of claims 1, 15-17, 25, and 26.
No time period for taking any subsequent action in connection with this
appeal may be extended under 3 7 C.F .R. § 1.13 6( a)( 1 )(iv).
AFFIRMED
7