Ex Parte Morazzoni et al

Patent Trials and Appeals Board

Jul 23, 2013

10587468 - (D) (P.T.A.B. Jul. 23, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte PAOLO MORAZZONI, ORLANDO PETRINI,
ANDREW SCHOLEY, and DAVID KENNEDY
1

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Appeal 2012-001287
Application 10/587,468
Technology Center 1600
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Before ERIC GRIMES, ERICA A. FRANKLIN, and
ANNETTE R. REIMERS, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for enhancing cognitive function, which have been rejected for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1
Appellants identify the Real Party in Interest as INDENA S.P.A. (Appeal
Br. 2).
Appeal 2012-001287
Application 10/587,468

2
STATEMENT OF THE CASE
The Specification discloses
the use of Ginkgo complexed with phosphatidylserine for the
manufacture of a medicament or dietary supplement for the
enhancement of cognitive function and mental fatigue. The
Ginkgo used is derived from the plant Ginkgo biloba, and
represents an extract or extracts thereof and/or the principal
active substances thereof.
(Spec. 5:5-9.)
Claims 23, 26-42, and 46 are on appeal. Claim 23 is illustrative and
reads as follows:
23. A method for enhancing cognitive function and alleviating mental
fatigue in a subject, comprising administering to a subject in need thereof an
effective amount of a Ginkgo-phospholipid complex, said complex
comprising Ginkgo complexed with a phospholipid, said phospholipid
comprising 20% phosphatidylserine.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 23, 26, 29-40, and 46 based on Physiologics
2
and
Bombardelli
3
(Answer 4);
• Claims 23, 26-41, and 46 based on Physiologics, Bombardelli, and
Loew
4
(Answer 8); and
• Claims 23, 26, 29-40, 42, and 46 based on Physiologics,
Bombardelli, and Kim
5
(Answer 10).

2
Phosphatidylserine Complex with Ginkgo, PhysioLogics (2003).
3
Bombardelli et al., EP 0 275 005, published July 20, 1988.
4
Loew, Value of Ginkgo biloba in treatment of Alzheimer dementia, 152
WIENER MEDIZINISCHE WOCHENSCHRIFT 418-22 (2002).
5
Kim, Proteomics of Neuroprotective Actions of Grape Seed Extract, 17
(no. 4-5) FASEB JOURNAL A278, abstract 179.3 (2003).
Appeal 2012-001287
Application 10/587,468

3
Each of the rejections relies on the combination of Physiologics and
Bombardelli. The Examiner finds that Physiologics discloses that a dietary
supplement comprising “phospholipid complex from soy lecithin
standardized to contain 20% phosphatidylserine” and Ginkgo biloba extract
is “perfect for mild memory problems associated with aging” (Answer 5),
but does not disclose a complex made up of phosphatidylserine and Ginkgo
extract (id. at 6).
The Examiner finds that “Bombardelli teaches complex compounds of
flavonoids with phospholipids,” where the flavonoids can be components of
Ginkgo biloba extract and the phospholipids can be phosphatidylserine (id.).
The Examiner concludes that it would have been obvious to form a complex
of the components of the Physiologics supplement because Bombardelli
teaches that a complex of flavonoids and phospholipids improves
bioavailability of the flavonoids (id.).
We agree with the Examiner that the cited references support a prima
facie case of obviousness with respect to claim 23. Appellants argue,
however, that they have “demonstrated that a complex of ginkgo-
phosphatidylserine provides superior results in cognitive function when
compared to the complex of ginkgo-phosphatidylcholine disclosed in
BOMBARDELLI” (Appeal Br. 9). Appellants also argue that they have
“show[n] that capsules containing the complex of Ginkgo with
phosphatidylserine show a remarkably higher and statistically meaningful
activity than that of capsules filled with Ginkgo biloba extract,
phosphatidylserine, or mixtures of Ginkgo biloba extract and
phosphatidylserine” (id. at 12).
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4
We agree with Appellants that the evidence of unexpected results
outweighs the evidence supporting the prima facie case of obviousness.
Physiologics discloses a physical (uncomplexed) mixture of Ginkgo biloba
extract and phosphatidylserine (Physiologics, “Supplement Facts”).
Bombardelli discloses a complex containing Ginkgo biloba extract and
phosphatidylcholine (Bombardelli 5, Table 1). Regardless of which
disclosure is considered the closest prior art, Appellants have provided
evidence to show that the complex of Ginkgo biloba extract and
phosphatidylserine provides significantly better improvement in cognitive
function.
The Specification provides a working example in which participants
were administered either a placebo, Ginkgo biloba extract, a complex of
Ginkgo biloba extract and phosphatidylcholine, or a complex of Ginkgo
biloba extract and phosphatidylserine (Spec. 22:15-22), and tested for
various cognitive functions (id. at 17-21). The “Speed of Memory” results,
for example, are shown in the application‟s Figure 2. The Specification
concluded:
It has been found that the ginkgo phosphatidylserine
complex used according to the present invention has an
outstanding higher effectivity compared with the other tested
species, i.e. not complexed ginkgo or ginkgo
phosphatidylcholine complex, regarding Quality of Memory,
Picture Recognition Accuracy, Speed of Memory, Timed
Memory Tasks and the majority of the tasks concerning
attention.
(Id. at 28:28 to 29:5.)
Appellants have also provided a declaration under 37 C.F.R. § 1.132
of Ezio Bombardelli (dated May 27, 2009). The Bombardelli Declaration
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Application 10/587,468

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states that subjects were treated with Ginkgo biloba extract (GE),
phospholipids containing 20% phosphatidylserine (PS), a mechanical
mixture of GE and PS, or GE-PS complexes (Bombardelli Decl., page 2),
and evaluated for Speed of Memory, Quality of Memory, and Picture
Recognition Accuracy as described in the Specification (id. at 3). The Speed
of Memory results are shown in a graph (id.). Mr. Bombardelli declares that
[t]he results obtained show that capsules containing Ginkgo
biloba-phosphatidylserine complexes show a remarkably and
unexpectedly higher, and statistically significant, activity
compared to capsules filled with Ginkgo biloba extract (GE),
phosphatidylserine (PS), or mixtures of Ginkgo biloba extract
and phosphatidylserine (GE + PS).
(Id.)
Thus, Appellants have provided evidence showing that a complex of
Ginkgo and phosphatidylserine is superior to either a complex of Ginkgo
and phosphatidylcholine or a physical mixture of Ginkgo and phosphatidyl-
serine in improving cognitive function. Appellants or their declarant have
stated that the claimed complex “has an outstanding higher effectivity”
(Spec. 29:1) compared to a complex of Ginkgo and phosphatidylcholine and
“a remarkably and unexpectedly higher, and statistically significant,
activity” compared to a physical mixture of Ginkgo and phosphatidylserine.
(Bombardelli Decl., page 3.)
The Examiner argues that the “allegedly „unexpected results‟ was
totally expected” because Physiologics teaches that Ginkgo combined with
phosphatidylserine is useful for mild memory problems and the Bombardelli
reference teaches that a complex of flavonoids and phospholipids improves
the therapeutic properties of the flavonoids (Answer 16). However, while
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Application 10/587,468

6
the Examiner is correct that the Bombardelli reference would have led those
skilled in the art to expect that complexing Ginkgo with a phospholipid
would provide some improvement in some of its effects, the Examiner has
not provided an adequate basis for concluding that the degree of
improvement actually shown, for the specific effects on cognitive function,
would have been expected based on the prior art. The Examiner therefore
has not provided a persuasive basis for not crediting Appellants‟ statements
in the Specification or the declaration testimony of Mr. Bombardelli.
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
“Rebuttal is merely „a showing of facts supporting the opposite conclusion,‟
and may relate to any of the Graham factors including so-called secondary
considerations.” In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984)
(citation omitted). “After evidence or argument is submitted by the
applicant in response, patentability is determined on the totality of the
record, by a preponderance of evidence.” Oetiker, 977 F.2d at 1445.
SUMMARY
The rejections on appeal are not supported by a preponderance of the
evidence of record, and are therefore reversed.

REVERSED

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