Ex parte Hirai et al.

Board of Patent Appeals and Interferences

Jun 29, 1999

07948470 (B.P.A.I. Jun. 29, 1999)

Application for patent filed September 22, 1992. According to the appellants, this1
application is a continuation of Application 07/272,960, filed November 18, 1988.
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publication in a law journal and (2) is not binding precedent of the Board.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. 50
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte FUMIYASU HIRAI and NOBUTAKA TANI
__________
Appeal No. 95-2484
Application 07/948,4701
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HEARD: JUNE 7, 1999
__________
Before WILLIAM F. SMITH, ELLIS and ROBINSON, Administrative Patent Judges.
ELLIS, Administrative Patent Judge.
DECISION ON APPEAL
This an appeal under 35 U.S.C. § 134 from the final rejection of claims 43 through
48, all the claims pending in the application.
Claims 43 and 46 are illustrative of the subject matter on appeal and read as
follows:
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43. A method for removing serum amyloid protein from body fluid in a human
mammal suffering from amyloidosis and in need of such treatment, comprising the
sequential steps of:
a) passing said mammal's body fluid containing serum amyloid protein through a
container having a fluid inlet and a fluid outlet and being packed with an adsorbent for a
serum amyloid protein comprising a water-insoluble carrier and dextran sulfate being
immobilized onto said carrier; and
b) returning substantially serum amyloid protein free body fluid to said human
mammal.
46. The method of claim 43, wherein said water-insoluble carrier is made of a
compound containing a hydroxy group.
The references relied on by the examiner are:
Serban et al. (Serban) 4,782,014 Nov. 1, 1988
Lehninger, Biochemistry, Second Edition, Chapter 9, “Enzymes: mechanism, structure
and regulation,” pp. 234-35 (1975)
Rubinow et al. (Rubinow), “Severe Intrahepatic Cholestasis in Primary Amyloidosis: A
Report of Four Cases and a Review of the Literature,” The American Journal of
Medicine, Vol. 64, pp. 937-46 (1978)
Pharmacia Fine Chemicals AB, “Gel Filtration Theory and Practice,” pp. 16 and 20
(1981)
Kato et al. (Kato), “A Therapeutic Trial of Plasmapheresis Combined with DMSO in a
Patient with Primary Amyloidosis,” Jikeikai Medical Journal, Vol. 31, pp. 165-67 (1984)
Appeal No. 95-2484
Application 07/948,470
The examiner has relied on an abstract from an electronic database. However,2
the date the abstract was publically available on line is not of record in
the file.
3
Margulis et al. (Margulis), “DIALOG file 155 abstract, Accession No. 86019544,
“Clinical effectiveness of the method of extracorporeal heparin precipitation of plasma
proteins (selective plasmapheresis) in patients with immune complex pathology”2
Homma et al. (Homma), “Comparison of Selectivity of LDL Removal by Double Filtration
and Dextran-Sulfate Cellulose Column Plasmapheresis,” Atherosclerosis,
Vol. 60, pp. 23-27 (1986)
BIO-RAD Price List L, “Chromatography Electrophoresis Immunochemistry Molecular
Biology HPLC,” pp. 49-67 (Jan. 1986)
The claims stand rejected as follows:
I. Claims 43 through 48 stand rejected under 35 U.S.C. § 101 as lacking
patentable utility.
II. Claims 43 through 48 stand rejected under 35 U.S.C. § 112, first paragraph,
as being based on a specification which fails to provide an adequate written description or
an enabling disclosure of the invention.
III. Claims 43 through 45, 47 and 48 stand rejected under 35 U.S.C. § 103 as
being unpatentable over Rubinow in view of Homma.
IV. Claim 46 stands rejected under 35 U.S.C. § 103 as being unpatentable over
Rubinow and Homma, in further view of the Bio-Rad catalog.
We have given careful consideration to the record before us which includes, inter
alia, the appellants’ main brief (Paper No. 37) and Reply Brief (Paper No. 41), the
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examiner’s Answer (Paper No. 39) and supplemental Answer (Paper No. 42), as well as
the three declarations of Mr. Hirai (attachments to Paper Nos. 9 and 14; and Paper No.
20), and we find ourselves in substantial agreement with the findings of facts and
conclusions of law set forth in the appellants’ briefs. Accordingly, we reverse all the
rejections for the reasons set forth therein. We comment only briefly.
With respect to the § 103 rejections, we agree with the appellants that there is
nothing in the applied prior art of record which would have suggested the claimed method
to one of ordinary skill in the art. The examiner alleges that it would have been obvious to
treat those patients of Rubinow who have both hypercholesterolemia and amyloidosis with
the hypercholesteremia dextran-sulfate cellulose column plasmapheresis technique
described by Homma. However, we find no evidence of record that patients having
systemic amyloidosis are likely to be afflicted with familial hypercholesterolemia, a genetic
disorder. Thus, treatment of the latter group of patients does not teach or suggest
treatment of the former. Nor is there any evidence
of record that the amyloid proteins removed from serum using the appellants’ method fall
within the types of lipoproteins which are selectively removed using the method of
plasmapheresis taught by Homma. Thus, in our view the removal of serum amyloid
proteins using dextran-sulfate cellulose column plasmapheresis from a patient afflicted with
amyloidosis differs from, and is not suggested by, the removal of low density
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lipoproteins from patients having familial hypercholesterolemia using substantially the
same method.
As to the § 101 rejection, we find that the examiner has proffered several theories
as to why he believes one skilled in the art would question the objective truth of the
statement of utility. Some of these theories are said to be based on the teachings of
various references; i.e., Kato, Margulis and Lehninger. However, we find that the examiner
has not applied the legal standard correctly. Since of the cited references, Lehninger does
not teach patients having the claimed disease; i.e., amyloidosis, and Kati and Margulis, do
not teach the appellants’ method of treating amyloidosis, there is no evidence of record
that one skilled in the art would have arrived at the same conclusions as the examiner.
Thus, although proffered under the guise “scientific reasoning,” the examiner’s theories are
undeniably speculative.
The decision of the examiner is reversed.
REVERSED
WILLIAM F. SMITH )
Administrative Patent Judge )
)
)
JOAN ELLIS ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
DOUGLAS W. ROBINSON )
Administrative Patent Judge )
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Application 07/948,470
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JE/cam
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