Ex Parte Toppo

Board of Patent Appeals and Interferences

Aug 14, 2012

11491718 (B.P.A.I. Aug. 14, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/491,718 07/24/2006 Frank Toppo 5125-001 6430
22429 7590 08/14/2012
LOWE HAUPTMAN HAM & BERNER, LLP
1700 DIAGONAL ROAD
SUITE 300
ALEXANDRIA, VA 22314
EXAMINER
KIM, JENNIFER M
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
08/14/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte FRANK TOPPO
____________

Appeal 2012-007579
Application 11/491,718
Technology Center 1600
____________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134 involves claims 13-33 (App. Br. 4;
Reply Br. 2; Ans. 3). We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to a method of treating a human in need of
treatment for Alzheimer‟s disease. Claims 1 and 33 are representative and
are reproduced in the Claims Appendix of Appellant‟s Brief.

Appeal 2012-007579
Application 11/491,718

2
Claims 13-33 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Lee.
1

Claims 13-33 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Cavazza
2
and Lee.
We vacate the rejection under 35 U.S.C. § 102(b) and affirm the
rejection under 35 U.S.C. § 103(a).

Obviousness:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Cavazza suggests a “method of treating . . . Alzheimer‟s disease . . .
compris[ing] administering to a patient in need thereof an effective amount
of admixed or separately packaged . . . (A) L-carnitine . . . and (B) a
trihydroxy or tetrahydroxystilbene”, in a “weight-to-weight ratio range[]
from 1:1 to 1:1,000” (Cavazza, col. 6, ll. 30-31 and col. 3, ll. 4-7; Ans. 6).
FF 2. Cavazza suggests that “[c]omponent (B) is preferably 3, 4‟, 5-
trihydroxystilbene (resveratrol)” (Cavazza, col. 2, ll. 59-60).
FF 3. Cavazza defines the term “resveratrol” as “both trans-3,4‟[,]5-
trihydroxystilbene (i.e. resveratrol proper) and the cis isomer, the respective
glycosides and extracts and powders containing resveratrol obtained from
any suitable plant species” (id. at col. 1, ll. 61-65 (emphasis added); see also
Ans. 6).

1
Lee et al., US 6,184,248 B1, issued February 6, 2001.
2
Cavazza, US 6,515,020 B1, issued February 4, 2003.
Appeal 2012-007579
Application 11/491,718

3
FF 4. Cavazza exemplifies “a formulation comprising 5 mg resveratrol
and 500 mg L-carnitine” (Ans. 6).
FF 5. Examiner finds that “Cavazza teaches lower amounts of resveratrol
but does not [t]each[, inter alia,] the higher daily amounts [or] dosing
frequency” (id.).
FF 6. Lee teaches a method of treating Alzheimer‟s disease comprising
administering resveratrol to a human in an amount from about 1 mg to about
1000 mg per day, in single or multiple doses from 1 mg, 5 mg, 10 mg, 500
mg or 1000 mg (Ans. 6-7; Lee, col. 18, ll. 20-25).
ANALYSIS
Based on the combination of Cavazza and Lee, Examiner concludes
that, at the time of Appellant‟s claimed invention, a person of ordinary skill
in this art would have found it prima facie obvious to administer trans-
resveratrol to a human at “its known amount effective for the treatment of
Alzheimer‟s disease” (Ans. 8).
Appellant provides separate arguments for the following groups of
claims: (I) Claims 13-32 and (II) Claim 33. Claims 13 and 33 are
representative. 37 C.F.R. § 41.37(c)(1)(vii).

Claim 13:
Cavazza suggests the use of trans-resveratrol to treat Alzheimer‟s
disease (FF 1-3). Therefore, we are not persuaded by Appellant‟s contention
that “there is no reason to select trans-resveratrol” from Cavazza‟s
disclosure (App. Br. 21).
A reference is not limited to its exemplified embodiments. In re
Mills, 470 F.2d 649, 651 (CCPA 1972). Therefore, we are not persuaded by
Appeal 2012-007579
Application 11/491,718

4
Appellant‟s contention or declaratory evidence
3
suggesting that Cavazza‟s
examples are “not relevant to Alzheimer‟s disease” (App. Br. 21-25). For
the same reasons, we are not persuaded by Appellant‟s contentions and
declaratory evidence, regarding Lee‟s examples (App. Br. 27-29).
Appellant contends, with reference to the Ensley Declaration, that
Cavazza‟s dosage range “is very broad” (App. Br. 25). “[W]here there is a
range disclosed in the prior art, and the claimed invention falls within that
range, there is a presumption of obviousness.” Iron Grip Barbell Co. v. USA
Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004); see also In re Geisler,
116 F.3d 1465, 1468 (Fed. Cir. 1997) (Overlapping ranges support a prima
facie case of obviousness). Therefore, the question is not whether Cavazza
suggests a broad effective dosage range, but instead the question is whether
the prior art relied upon by Examiner fails to suggest a daily dosage of trans-
resveratrol that falls within the scope of Appellant‟s claimed invention (App.
Br. 25).
While Cavazza fails to exemplify, or in Examiner‟s words - explicitly
“teach”, a daily resveratrol dosage in an amount between 200 mg and 1,000
mg; Cavazza suggests the administration of 500 mg of L-carnitine (FF 4; Cf.
FF 5). Cavazza also suggests the treatment of Alzheimer‟s disease by
administration of L- carnitine and trans-resveratrol at a 1:1 weight to weight
ratio (FF 1-3). Thus, Cavazza suggests the administration of 500 mg L-
carnitine and 500 mg trans-resveratrol, i.e., a 1:1 weight to weight ratio, for
the treatment of Alzheimer‟s disease. This dosage of resveratrol is fully

3
Declaration of Harry Ensley, Ph.D., executed January 28, 2010;
Declaration of Frank Toppo, MD, executed February 16, 2011; and
Declaration of Charles Bernick, MD, executed February 1, 2011.
Appeal 2012-007579
Application 11/491,718

5
supported by Lee (FF 6). Further, because Lee is not relied upon in
isolation, but is instead applied in combination with Cavazza, we are not
persuaded by Appellant‟s contention, with reference to the Ensley and
Toppo declarations, that Examiner‟s reliance on Lee is “meaningless due to
the range of compounds embraced by Lee” (App. Br. 26; see FF 6).
Lastly, we are not persuaded by Appellant‟s contention that “whatever
Lee‟s resveratrol is, it is not trans-resveratrol” (App. Br. 29). Appellant fails
to establish that Lee‟s resveratrol falls outside the scope of the term
“resveratrol” as defined by Cavazza (see FF 3). Accordingly, we are not
persuaded by Appellant‟s intimation that Lee‟s resveratrol falls outside the
scope of Cavazza‟s definition of the term (App. Br. 29).
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii).

Claim 33:
Appellant‟s claim 33 is drawn to a method of treating a human in need
of treatment for Alzheimer‟s disease (Claim 33). Appellant‟s claimed
method comprises the administration of a composition consisting essentially
of trans-resveratrol in a daily amount between 200 mg and 1,000 mg (id.).
Appellant appears to be of the opinion that claim 33 is somehow
limited to the administration of a specific composition that consists
essentially of trans-resveratrol in a specified dosage (App. Br. 30-31). We
are not persuaded. In addition to the following, we incorporate our
discussion with respect to claim 1 herein by reference.
Notwithstanding Appellant‟s contention to the contrary, the method of
claim 33, is not limited to the administration of one specific composition,
Appeal 2012-007579
Application 11/491,718

6
but instead comprises the administration of a composition.
4
Stated
differently, the use of the transitional phrase “comprising” opens the method
of claim 33 to include not only the administration of (i) a composition
consisting essentially of trans-resveratrol in a specified concentration; but
also (ii) the administration of L-carnitine in a specified concentration. Thus,
claim 33 reads on Cavazza‟s suggested method, as modified by Lee, of
treating Alzheimer‟s disease, which comprises administering to a patient in
need thereof an effective amount of separately packaged (A) L-carnitine of a
particular dosage and (B) trans-resveratrol of a particular dosage (FF 1-4 and
6).
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii).
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claims 13 and 33 under 35 U.S.C. § 103(a)
as unpatentable over the combination of Cavazza and Lee is affirmed.
Claims 14-32 are not separately argued and fall together with claim 13. 37
C.F.R. § 41.37(c)(1)(vii).

SUMMARY
We vacate the rejection of claims 13-33 under 35 U.S.C. § 102(b) as
being anticipated by Lee.

4
See In re Crish, 393 F.3d 1253, 1257 (Fed. Cir. 2004) (“The reasonable
interpretation of the claims containing both of the terms „comprising‟ and
„consists‟ is that the term „consists‟ limits the „said portion‟ language to the
subsequently recited” substance, “but the earlier term „comprising‟ means
that the claim can include that portion plus other” substances).

Appeal 2012-007579
Application 11/491,718

7
We affirm the rejection of claims 13-33 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Cavazza and Lee.
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. § 1.136(a).

AFFIRMED

alw