Ex parte Gaull

Board of Patent Appeals and Interferences

Mar 31, 1999

07759100 (B.P.A.I. Mar. 31, 1999)

Application for patent filed September 6, 1991. 1
According to applicant, the application is a continuation of
Application 07/247,981, filed September 22, 1988.
1
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(2) is not binding precedent of the Board.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. 37
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_____________
Ex parte GERALD E. GAULL
_____________
Appeal No. 95-3337
Application 07/759,1001
______________
ON BRIEF
_______________
Before WINTERS, KIMLIN, and GARRIS, Administrative Patent
Judges.
GARRIS, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on an appeal from the final rejection
of claims 40 and 42 through 50 which are all of the claims
Appeal No. 95-3337
Application No. 07/759,100
2
remaining in the application.
The subject matter on appeal relates to an artificial
human infant formula which includes recombinant human virus-
free human milk protein. Further details of this appealed
subject matter are set forth in representative independent
claim 40 which reads as follows:
40. In an artificial human infant formula based on
bovine or soy proteins, the improvements comprising a
recombinant human virus-free human milk protein having the
same function as human milk protein in approximately the
amount present in human milk wherein the recombinant human
milk protein is selected from the group consisting of
secretory immunoglobulin-A, lactoferrin, lactoperoxidase,
lysozyme, alpha-lactalbumin, alpha-casein, beta-casein, kappa-
casein, and combinations thereof.
The references relied upon by the examiner as evidence of
obviousness are:
Müeller et al. (Müeller) 4,216,236 Aug. 5, 1980
Friend et al. (Friend), "Newer Advances in Human Milk
Substitutes for Infant Feeding," 35 J. Applied Nutrition, no.
2, 88-115 (1983).
Lindblad et al. (Lindblad), "Lactoengineering: A Method for
the Estimation of the Human Milk Protein Requirements of Very-
Low-Birth-Weight Newborn Infants," in Williams et al.
(Editor), Human Milk Banking, 159-169 (New York, Nestlé
Nutrition, 1984).
Raiha, "Nutritional Proteins in Milk and the Protein
Requirement of Normal Infants," Pediatrics, 136-141 (1985).
Appeal No. 95-3337
Application No. 07/759,100
3
Rhein, Biotechnology, "Freeing Hemophiliacs from the Risk of
AIDS," Business Week, 38 (New York, McGraw-Hill, Inc., 1987)
(referred to hereinafter as Biotechnology article).
Appeal No. 95-3337
Application No. 07/759,100
In the body of the Answer, the examiner also refers to2
certain portions of the subject specification which she
implies represent admitted prior art. For example, on page 6
of the answer in discussing the here-claimed recombinant human
virus-free human milk protein, the examiner states:
"Appellant has apparently not developed these proteins, but is
substituting them for known human milk proteins to make a
humanized milk product. See page[s] 7-10 of appellant[']s
specification for known genetically engineered proteins"
(emphasis added). However, it is well settled that, where
prior art is relied on to support a rejection, there would
appear to be no excuse for not positively including the prior
art in the statement of rejection. In re Hoch, 428 F.2d 1341,
1342 n.3, 166 USPQ 406, 407 n.3 (CCPA 1970). As a
consequence, we will assess the examiner's conclusion of
obviousness based solely upon the above-noted prior art
references which are positively included in the examiner's
statement of rejection. The examiner's aforementioned
referrals to the subject specification in support of her
obviousness conclusion are additionally inappropriate because
the record before us is considerably unclear as to
specifically what portions of the specification disclosure,
including those portions which discuss recombinant human milk
protein of the type here claimed, represent subject matter
known in the prior art. This last mentioned point is
reinforced by the examiner's use of the aforequoted term
"apparently." We here emphasize that a rejection under 35
U.S.C. § 103 must rest on a factual basis rather than
conjecture, speculation or assumption. In re Warner, 379 F.2d
1011, 1017, 154 USPQ 173, 178, cert. denied, 389 U.S. 1057
(1968).
4
All of the claims on appeal stand rejected under 35
U.S.C. § 103 as being unpatentable over Müeller in view of
Lindblad and further in view of Raiha and Friend and the
Biotechnology article. 2
Appeal No. 95-3337
Application No. 07/759,100
5
Appeal No. 95-3337
Application No. 07/759,100
In our opinion, the exposition of obviousness set forth3
in the dissent does not represent the rejection formulated by
the examiner and advanced on the subject appeal. Merely by
way of example, the EPO application, which the dissent depends
upon as support for an obviousness conclusion, is never
specifically referred to by the examiner in her Answer.
6
We refer to the brief and reply brief and to the answer
for a complete exposition of the opposing viewpoints expressed
by the appellant and the examiner concerning this rejection.
OPINION
As correctly indicated by the appellant in the briefs,
none of the references applied by the examiner in her
rejection contains any teaching or suggestion that any of the
recombinant human milk proteins recited in the appealed claims
were known in the prior art at the time the here-claimed
invention was made much less that it would have been obvious
to use such recombinant proteins in an artificial human infant
formula so as to avoid the problem addressed by the appellant,
namely, the potential of viral contamination. As a result, it
is clear to us that we cannot sustain the examiner's Section
103 rejection of the appealed claims as being unpatentable
over Müeller in view of Lindblad and further in view of Raiha
and Friend and the Biotechnology article.3
Appeal No. 95-3337
Application No. 07/759,100
Rather, in the Answer, the examiner broadly refers to portions
of the specification (e.g., pages 7-10) which she seems to
believe represent acknowledged prior art. This merits panel
has not been briefed by the appellant or the examiner
respecting those portions of EPO Application 181,634 which may
teach toward or away from the claimed invention. In fact, it
is unclear whether the EPO application is even of record. For
these reasons, we will not assess or further comment upon the
obviousness exposition of the dissent.
7
The decision of the examiner is reversed.
REVERSED
SHERMAN D. WINTERS )
Administrative Patent Judge )
) BOARD OF PATENT
) APPEALS AND
) INTERFERENCES
BRADLEY R. GARRIS )
Administrative Patent Judge )
KIMLIN, Administrative Patent Judge, dissenting:
I respectfully disagree with the conclusion reached by
the majority. Since appellant's specification readily
acknowledges that it was known to formulate synthetic infant
milk based on cow's milk (page 1 of specification), and that
EPO Application 181,634 discloses the production of human
lysozyme by recombinant genetic engineering techniques
Appeal No. 95-3337
Application No. 07/759,100
8
(paragraph bridging pages 6 and 7 of specification), I am of
the opinion that one of ordinary skill in the art would have
found it prima facie obvious to include the recombinant
lysozyme of EPO '634 in a synthetic human infant formula. In
my view, incorporating recombinant lysozyme in an artificial
human infant formula would have been an obvious use of the
genetically engineered lysozyme disclosed by EPO '634. I find
this particularly so since appellant's specification states at
page 6 that "it has even been proposed to employ human
lysozyme derived from human milk to enrich synthetic cow milk
based formula so that the lysozyme-enriched cow-based infant
formula more closely approximates human milk with respect to
lysozyme content and activity. . . ." I agree with the
examiner that one of ordinary skill in the art would have had
a reasonable expectation that recombinant lysozyme is free of
human viruses. Indeed, appellant acknowledges at page 6 of
his specification that contamination with human virus "is not
a reasonable possibility when the human milk proteins,
including the so-called host resistance factors, are produced
as recombinant human milk proteins or recombinant host
resistant factors employing genetic engineering techniques."
Appeal No. 95-3337
Application No. 07/759,100
In re Nielson, 816 F.2d 1567, 1572, 2 USPQ2d 1525, 15284
(Fed. Cir. 1987); Ex parte Schier, 21 USPQ2d 1016, 1018-19
(Bd. Pat. App. & Int. 1991). See also 37 CFR § 1.192(c)(7)
and (c)(8).
9
I have reviewed the declaration of Dr. Lars Hanson, but
absent therein is any discussion of the obviousness of
including the recombinant lysosyme disclosed by EPO '634 in an
infant formulation.
As a final point, I am aware that only claims 40 and 45
define the use of recombinant lysosyme. However,
notwithstanding appellant's submission at page 3 of the
principal brief that the appealed claims are considered to be
separately patentable, appellant's brief fails to advance any
argument that is reasonably specific to any particular claim
on appeal. Accordingly, it is my view that all of the
appealed claims stand or fall together with claim 40, and,4
therefore, I would sustain the examiner's rejection under 35
U.S.C. § 103 which relies upon the acknowledged prior art
found in appellant's specification.
)
)
) BOARD OF PATENT
Appeal No. 95-3337
Application No. 07/759,100
10
EDWARD C. KIMLIN ) APPEALS AND
Administrative Patent Judge ) INTERFERENCES
BRG/ECK:svt
Appeal No. 95-3337
Application No. 07/759,100
11
John J. McDonnell
ALLEGRETTI & WITCOFF, LTD.
10 South Wacker Drive
Chicago, IL 60606