Ex Parte Zohoungbogbo

Board of Patent Appeals and Interferences

Oct 30, 2009

09982554 (B.P.A.I. Oct. 30, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte MATHIAS C. ZOHOUNGBOGBO,
Appellant
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Appeal 2008-005274
Application 09/982,554
Technology Center 1600
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Decided: October 30, 2009
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Before CAROL A. SPIEGEL, DONALD E. ADAMS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

SPIEGEL, Administrative Patent Judge.

DECISION ON REHEARING
Appellant requests a rehearing under 37 C.F.R. § 41.52(a)(1) of the
Decision entered February 12, 2009 ("Decision") in which the obviousness
rejections of claims 45-47, 49-52, and 54-56 were affirmed, but denominated
as a new ground of rejection. We have jurisdiction under 35 U.S.C. § 134
(a).

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I. Statement of the Case
The appealed claims are directed to a method of treating a person on a
ketogenic diet to reduce the amount of cholesterol, triglycerides, glucose,
uric acid, transaminases, and fibrinogen in the person's body by
administering a defined composition. The composition administered in the
method of claim 45 comprises (a) 7-23%1 benfluorex or 14-17%
ursodeoxycholic acid as a hypocholesterolemic agent, (b) 7-23% benfluorex
as a hypotriglyceride agent, (c) 27-43% pancreatic IX F.U. as a lipasic and
proteasic agent, (d) 36-41% metformin as a hypoglycemic agent, and (e) 9-
14% Na dehydrocholate as a hydrocholeretic agent.
We agreed with the Examiner “that it would have been prima facie
obvious to treat known side effects of a ketogenic diet, e.g., increased serum
cholesterol, with a combination of known cholesterol-lowering drugs, e.g.,
benfluorex, metformin, and ursodeoxycholic acid” (Decision 10). However,
we determined that the Examiner had not provided a sufficient factual basis
to conclude “that it would have been prima facie obvious to incorporate
pancreatin and sodium dehydrocholate into a cholesterol lowering
composition containing metformin” (id.). Since the prior art disclosed an
antispasmodic composition containing pancreatin and sodium
dehydrocholate for treating abdominal cramps associated with flatulence (id.
6-7), we sua sponte found that the prior art disclosed that abdominal cramps
(gastrointestinal pain) and flatulence (meteorism) are common side effects of
taking metformin and, therefore, concluded “that it would have been prima
facie obvious to include pancreatin and sodium dehydrocholate in a

1 All references to "%" are to weight % of the total amount of the
composition.
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cholesterol lowering composition containing metformin” to treat the known
common side effects of abdominal cramps and flatulence (id. 10-11). Thus,
since our decision was based on a different factual basis than presented by
the Examiner, it was designated as a new ground of rejection (id. 12).
We further noted that Appellant had not submitted evidence rebutting
the Examiner's conclusion that optimizing the amount of each active agent in
the composition would have been within ordinary skill in the art (id. 8 and
11) or other evidence of nonobviousness, such as evidence of unexpected
results or synergy (id. 11).
II. Points Believed to have been Overlooked or Misapprehended
Appellant submits that "even if each of the references independently
teach certain elements of the claims, there is no teaching or suggestion, nor
is it implict within the art, to combine the reference to arrive at the present
invention" (RR2 4) absent hindsight reconstruction (id. 5). Appellant argues
[n]ot only were specific agents selected to treat
specific side effects, but they were added within
limited ranges. . . The ranges work, particularly in
combination with the other components and the
ranges claimed for them. Appellant acknowledges
that for each component taken alone, there may be
existing dosage knowledge, with routine
experimentation needed to select one. However,
the ranges claimed are for several claimed
components and the requirement to show
obviousness, must render obvious the relative
concentrations to one another as that is what claim
45 is claiming, among other elements. [RR 6-7.]
Appellant also attached a copy of the April 16, 2003, Declaration of Mr.
Zohoungbogbo to the Request for Rehearing (RR 1-2).

2 Request for Rehearing filed 11 May 2009 ("RR").
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III. Legal Principles
A request for rehearing must state with particularity the points
believed to have been misapprehended or overlooked by the Board.
Arguments not raised in the briefs before the Board and evidence not
previously relied upon in the brief and any reply brief(s) are not permitted in
the request for rehearing except that, upon a showing of good cause,
Appellant may present a new argument based upon a recent relevant
decision of either the Board or a Federal Court. 37 C.F.R. § 41.52(a)(1) and
(2). New arguments responding to a new ground of rejection made pursuant
to § 41.50(b) are permitted. 37 C.F.R. § 41.52(a)(3).
When the Board makes a new ground of rejection, the Appellant may
ask for prosecution to be reopened before the Examiner. 37 C.F.R. §
41.50(b)(1).
IV. Analysis
Appellant essentially reiterates the hindsight reconstruction arguments
made in the Brief. As stated in the Decision (Decision 8),
“The combination of familiar elements
according to known methods is likely to be
obvious when it does nothing more than yield
predictable results." KSR, 127 S.Ct. at 1739. "It is
prima facie obvious to combine two compositions
each of which is taught by the prior art to be useful
for the same purpose, in order to form a third
composition which is to be used for the very same
purpose." In re Kerkhoven, 626 F.2d 846, 850
(CCPA 1980). "[D]iscovery of an optimum value
of a result effective variable in a known process is
ordinarily within the skill of the art." In re Boesch,
617 F.2d 272, 276 (CCPA 1980). See also In re
Reese, 290 F.2d 839 (CCPA 1961).
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Here, it would have been obvious to combine the known cholesterol
lowering agents, benfluorex, metformin, and ursodeoxycholic acid into a
single composition to treat known side effects of a ketogenic diet, such as
elevated serum cholesterol. It would have been further obvious to add
pancreatin and sodium dehydrocholate to the metformin-containing
composition to relieve the known common side effects of metformin
(Decision 8 and 10-11). It is well established that the Examiner's/Board's
reason for incorporating pancreatin and sodium dehydrocholate into the
metformin-containing composition need not be the same as Appellant's.
KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007); In re Dillon, 919
F.2d 688, 693-94 (Fed. Cir. 1990). Since this argument has already been
addressed in the Decision, it cannot have been overlooked or
misapprehended.
Appellant newly argues that the prior art must not only suggest
combining the claimed components into a composition, but also in their
recited percentage weight (RR 6-7). However, Appellant has not shown
good cause why this argument was not earlier presented in its Brief since it
could have been made in response to the Examiner's conclusion that
optimizing the amount of each active agent in the composition would have
been within ordinary skill in the art. Nonetheless, we recognize that new
arguments responding to a new ground of rejection made pursuant to
§ 41.50(b) are permitted. 37 C.F.R. § 41.52(a)(3). However, as noted in the
Decision, Appellant has not submitted evidence showing that optimizing the
amount of each active agent in the composition would have been outside the
ordinary skill in the art (Decision 8 and 11) or other evidence of
nonobviousness, such as evidence of unexpected results or synergy (id. 11).
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In re Schulze, 346 F.2d 600, 602 (CCPA 1965) (argument in the brief does
not take the place of evidence of record).
Finally, while the Zohoungbogbo Declaration attached to the Request
for Rehearing was not attached to Brief, its substance was argued by
Appellant in the Brief at page 17, i.e.,
the inventor Mr. Zohoungbogbo, stated that
administration of the composition from Example 8
to patients undergoing a ketogenic diet …
maintained normal levels of cholesterol,
triglycerides, glycemia, uric acid, transaminases
and fibrinogen.
* * * * * *
… on page 5, last paragraph, Mr. Zohoungbogbo
further states … "Nobody has demonstrated a
surprising synergic effect of a composition as the
one of my invention comprising more than two
active ingredients."
As stated in the Decision, the composition of Example 8 is outside of the
claimed subject matter because it contains 46.1% metformin (Decision 12).
Since the showing in the Zohoungbogbo Declaration is not commensurate in
scope with the claimed invention, it is insufficient to rebut the prima facie
conclusion of obviousness.
V. Conclusion
Accordingly, we decline to reverse our decision of February 12, 2009
that claims 45-47, 49-52, and 54-56 are unpatentable as obvious under 35
U.S.C. § 103(a) over the applied prior art.

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VI. Order
Upon consideration of the record, and for the reasons given, it is
ORDERED that the request for rehearing is DENIED.
DENIED

rvb

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