Ex parte LA GRECA

Board of Patent Appeals and Interferences

Feb 17, 2000

08108005 (B.P.A.I. Feb. 17, 2000)

THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered
today (1) was not written for publication in a law
journal and (2) is not binding precedent of the
Board.
Paper No. 34
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte PIETRO LA GRECA
____________
Appeal No. 1997-1987
Application No. 08/108,005
____________
ON BRIEF
____________
Before WINTERS, WILLIAM F. SMITH, and LORIN, Administrative
Patent Judges.
WINTERS, Administrative Patent Judge.
DECISION ON APPEAL
I. This is an appeal from the final rejection of claims
13 through 18 and 22 through 26, all the claims remaining in
the present application.
II. Background
Frequently, patients infected with the Human
Immunodeficiency Virus (HIV) have accompanying neurological
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Application No. 08/108,005
2
complications. This is manifested by demyelination, in the
form
of multifocal progressive leukoencephalopathy. Symptoms range
from slight psychic disturbance to a clear neurological
syndrome. Approximately ten percent of AIDS patients show
serious neurological symptoms (aphasia, ataxia, areflexia,
including paralysis and loss of sphincteric control); and in
sixty-two percent of HIV-positive subjects, organic mental
disturbances are described leading to alteration of the
cognitive functions and to dementia. Specification, page 1,
line 14, to page 2, line 3. The literature has reported that
HIV-positive patients with accompanying neurological
complications can exhibit deficiencies in 5-methyl-
tetrahydrofolate (MTHF) and S-adenosylmethionine (SAMe).
Specification, page 2, lines 3-5. Data from the literature
suggest that deficiencies in MTHF and SAMe can be the cause of
neurological degeneration in AIDS patients. Specifica-tion,
page 2, line 16, to page 3, line 3. Administration of
methionine and betaine has been suggested to correct these
metabolic deficiencies. R. Surtees et al., The Lancet, vol.
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Application No. 08/108,005
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335, March 1990. Specification, at page 3, lines 4-5.
However, appellant has found that administering methionine and
betaine at doses of 6 g/day for 14 days was not able to
significantly increase MTHF and SAMe body fluid levels.
Specification, page 3, lines 6-8.
III. Representative claims
Claims 15, 17, 22, and 23 are illustrative of the subject
matter on appeal and read as follows:
22. A therapeutic method for treating neurological
affections [sic] selected from the group consisting of
subacute encephalitis associated with dementia and vacuolar
myelopathies comprising administering to a patient in need
thereof a therapeutically effective amount of at least one
member selected from the group consisting of S-adenosyl-
methionine salt, 5-methyltetrahydrofolic acid and 5-
formyltetrahydrofolic acid.
15. A therapeutic method according to claim 22, wherein
the S-adenosylmethionine is administered at doses ranging from
100 and 2000 mg/day.
17. A therapeutic method according to claim 22,
wherein 5-methyltetrahydrofolic acid or 5-
formyltetrahydrofolic acid is administered at doses ranging
from 20 and 200 mg/day.
23. A therapeutic method according to claim 22, wherein
the S-adenosyl-methionine salt is administered at the same
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Application No. 08/108,005
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time or at close intervals with 5-methyltetrahydrofolic acid
or with 5-formyltetrahydrofolic acid.
IV. References
The references relied on by the examiner are:
Le Grazie 5,059,595 Oct. 22, 1991
Surtees et al. (Surtees), “Central-nervous system
methyl-group metabolism in children with
neurological complications of HIV infection,” The
Lancet, vol. 335, pp. 619-621 (1990).
V. Rejections
The claims stand rejected as follows:
Claims 17, 18 and 22 under 35 U.S.C. § 102(e) as
anticipated by Le Grazie.
Claims 13 through 18 and 22 through 26 under 35 U.S.C. §
103 as unpatentable over the combined teachings of Le Grazie
and Surtees.
VI. Discussion
A. Rejection of claims 17, 18 and 22 under 35 U.S.C.
§ 102(e) as anticipated by Le Grazie.
1. The claimed subject matter is drawn to a therapeutic
method for treating neurological afflictions selected from the
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group consisting of subacute encephalitis associated with
dementia and vacuolar myelopathies. The method comprises
administering to a patient in need thereof a therapeutically
effective amount of at least one member selected from the
group consisting of S-adenosyl-methionine salt, 5-
methyltetrahydrofolic acid and 5-formyltetrahydrofolic acid.
2. Anticipation under 35 U.S.C. § 102 requires a prior
art reference to disclose each and every element set forth in
the claims. See RCA Corp. v. Applied Digital Data System,
Inc., 730 F.2d 1440, 1444, 221 USPQ 385, 388 (Fed. Cir. 1984).
3. Le Grazie discloses a therapeutic method for treating
organic mental disorders, in particular senile and presenile
primary degenerative Alzheimer dementia and multiinfarctual
dementia. The method comprises orally administering a
therapeu-tically effective amount of 5-methyl-tetrahydrofolic
acid or 5-formyl-tetrahydrofolic acid or a pharmaceutically
acceptable salt thereof in a controlled release form. Le
Grazie, col. 1, lines 11-21, col. 2, lines 7-46. However, Le
Grazie does not disclose treating a patient afflicted with
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subacute encephalitis associated with dementia or vacuolar
myelopathies.
4. In the Brief, pages 8 through 11, appellant argues
that there are significant distinctions between the organic
mental disorders described by Le Grazie and “subacute
encephalitis associated with dementia and vacuolar
myelopathies” recited in claim 22. Appellant argues that
Le Grazie is directed to treating neuro-degenerative
pathologies, whereas the claimed therapeutic methods are
directed to treating pathologies “having a completely
different origin.” Brief, page 8, line 15, through page 9,
line 7; and page 9, lines 20-23. Appellant further argues
that senile or presenile dementia caused by Alzheimer’s
disease and multiinfarctual dementia have a different etiology
than dementia caused by encephalitis. Brief, page 10, lines
1-9. The Rule 132 Declaration of Pietro Monaco, Paper No. 21,
filed 10 April 1995, defines subacute encephalitis as
“inflammation of the
brain,” and vacuolar myelopathy as “a disease of the spinal
cord.” According to Monaco, dementia associated with subacute
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encephalitis is caused by an inflammatory state of the brain;
in contrast, senile or presenile dementia caused by
Alzheimer’s disease is characterized by diffuse cerebral
cortical atrophy, and microscopically by the presence of
argyrophil cells, loss of neurons, and neurofibrillary
tangles. Monaco states that multiinfarctual dementia is
generated by the presence in the brain of a series of infarcts
(localized circumscribed areas of ischemic tissue necrosis,
due to inadequate blood flow), and cannot be considered
equivalent to dementia associated with encephalitis.
5. The examiner argues that “appellant’s encephalitis
associated with dementia and of vacuolar myelopathies is
inherently encompassed in the dementia of the reference,
especially in the absence of evidence to the contrary.”
Answer, page 4, lines 8-11. However, the examiner fails to
provide a basis in fact or technical reasoning which would
reasonably support the determination that encephalitis
associated with dementia and vacuolar myelopathies are
inherently disclosed by Le Grazie. See Ex parte Levy, 17
USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990), and cases
cited therein.
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The examiner admits that the etiology of dementia caused
by encephalitis differs from that caused by Alzheimer’s
disease, as shown in the Monaco declaration. However, the
examiner states that “appellant has not conclusively shown the
experimental evidence, so that the two phenomena can be
distinguished.” Answer, page 4, lines 22-23.
The examiner does not provide facts or scientific
reasoning which would cast doubt on statements in the Monaco
declaration that senile or presenile dementia caused by
Alzheimer’s disease and multiinfarctual dementia have a
completely different pathology from dementia caused by
encephalitis.
On this record, the examiner has not shown that treating
patients afflicted with subacute encephalitis associated with
dementia or vacuolar myelopathies by administering 5-methyl-
tetrahydrofolic acid or 5-formyl-tetrahydrofolic acid is
described by or inherently flows from Le Grazie.
Accordingly, we reverse the examiner’s decision rejecting
claims 17, 18 and 22 under 35 U.S.C. § 102(e) as anticipated
by Le Grazie.
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9
B. Rejection of claims 13 through 18 and 22 through 26
under 35 U.S.C. § 103 as unpatentable over the combined
teachings of Le Grazie and Surtees.
1. To establish prima facie obviousness of the claimed
subject matter, all the claim limitations must be taught or
suggested by the prior art. See In re Royka, 490 F.2d 981,
985, 180 USPQ 580, 583 (CCPA 1974).
2. For the reasons previously set forth, Le Grazie fails
to disclose treating a patient afflicted with subacute
encephalitis associated with dementia or vacuolar
myelopathies. Surtees discloses that levels of S-
adenosylmethionine and 5-methyl-tetrahydrofolate in the
cerebrospinal fluid (CSF) of children afflicted with subacute
HIV encephalitis and neurological complications are lower than
those determined in a reference population of children. Low
levels of S-adenosylmethionine and 5-methyl-tetrahydrofolate
demonstrate defective methyl-group metabolism, which Surtees
suggests may be related to the neurological damage in HIV
infection. Surtees, page 619, paragraph bridging cols. 1 and
2; page 621, first full paragraph; Fig. 1. Though Surtees
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suggests that treatment with methyl-group donors such as
betaine and methionine could be useful in HIV infection if the
role of defective methyl-group metabolism is confirmed,
nevertheless, Surtees does not disclose or suggest
treating children with HIV-encephalitis by administering
S-adenosylmethionine salt or 5-methyl-tetrahydrofolic acid, as
recited in claim 22. Accordingly, Surtees does not make up
the deficiencies of Le Grazie, and we reverse the examiner’s
decision rejecting claims 13 through 18 and 22 through 26
under 35 U.S.C. § 103 as unpatentable over the combined
disclosures of Le Grazie and Surtees.
VII. Conclusion
In conclusion, for the reasons set forth in the body of
this opinion, we reverse the examiner’s decision rejecting
claims 13 through 18 and 22 through 26.
REVERSED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
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)
)
) BOARD OF PATENT
WILLIAM F. SMITH ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
HUBERT C. LORIN )
Administrative Patent Judge )
vsh
Appeal No. 1997-1987
Application No. 08/108,005
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