Ex parte PABST

Board of Patent Appeals and Interferences

Jul 27, 1998

07885490 - (D) (B.P.A.I. Jul. 27, 1998)

Application for patent filed May 19, 1992. 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journal and (2) is not binding precedent of the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. 21
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte PATREA L. PABST
____________
Appeal No. 95-0523
Application No. 07/885,4901
____________
HEARD: February 6, 1998
____________
Before WINTERS, SOFOCLEOUS and WEIMAR, Administrative Patent
Judges.
WEIMAR, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal from the examiner's decision finally
rejecting claims 1-26.
Claims 1, 12 and 24-26 are illustrative of the subject
matter and they read as follows:
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Application No. 07/885,490
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1. An improved non-human milk baby formula including
protein, carbohydrate and lipid which is suitable for
administration to an infant comprising an enzyme selected from
the group consisting of protease enzymes and polysaccharide
degrading enzymes, wherein the enzyme is in a form that will
be enzymatically active in the digestive system of an infant
to whom the baby formula is administered and is present in an
amount effective to completely digest the enzyme substrate in
the formula by the time the substrate reaches the end of the
colon.
12. A method for improving the digestibility of a non-
human milk baby formula which is suitable for administration
to an infant comprising providing in the formula an enzyme
selected from the group consisting of proteases and
polysaccharide degrading enzymes, wherein the enzyme is in a
form that will be enzymatically active in the digestive system
of an infant to whom the baby formula is administered and is
present in an amount effective to completely digest the enzyme
substrate in the formula by the time the substrate reaches the
end of the colon.
24. An additive to increase digestibility of non-human
milk baby formula comprising a purified protease in
combination with a purified polysaccharide degrading enzyme.
25. The additive of claim 24 further comprising a
lipase.
26. The additive of claim 24 further comprising a simple
carbohydrate degrading enzyme selected from the group
consisting of lactase, sucrase, fructase, and extract of
Aspergillus niger.
The references relied upon by the examiner are:
Gaull 4,303,692 Dec. 1,
1981
Puski et al. (Puski) 4,830,861 May 16,
1989
Schweikhardt et al. (Schweikhardt) 4,925,680 May 15,
1990
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Application No. 07/885,490
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Tang et al. (Tang) 4,944,944 Jul. 31,
1990
Jost et al. (Jost) 5,039,532 Aug. 13,
1991
Appeal No. 95-0523
Application No. 07/885,490
The prosecution history refers to this document as2
“Miles (EP’986)” or “Miles.” We refer to the first-named
inventor rather than the corporate applicant.
4
Faigh et al. (Faigh) EP-325-986-A Aug. 02, 19892
Additional references discussed in this decision are:
Mochizuki et al. 3,615,687 October 26,
1971 (Mochizuki)
Sipos 4,079,125 March 14, 1978
Roy 4,826,679 May 2, 1989
Claims 1-26 stand rejected under 35 U.S.C. § 103 over
Gaull in view of Jost, Faigh, Schweikhardt, Puski and Tang.
We reverse this rejection.
Claims 24-26 are newly rejected under 35 U.S.C. § 102
infra.
BACKGROUND
Claims 1-11 are directed to non-human milk compositions
designed for feeding infants which in addition to unspecified
protein, carbohydrate and lipid components contain an enzyme
selected from proteases and polysaccharide-degrading enzymes.
Composition claim 1 requires that the enzyme be in an active
form in the digestive system of an infant and present in the
formula in an amount effective to completely digest the enzyme
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substrate contained in the formula. Claims 12-23 are directed
to methods
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of making the formula compositions of the above claims.
Claims 24-26 are directed to additive compositions containing
specified enzymes.
As discussed on pages 1 and 2 of the specification,
pediatricians recommend feeding infants with human breast
milk. The claimed compositions are designed to mimic breast
milk which contains proteases and polysaccharide-degrading
enzymes in an active form.
DISCUSSION
The appealed rejection under 35 U.S.C. § 103
Claims 1-26 stand rejected under 35 U.S.C. § 103 over
Gaull in view of Jost, Faigh, Schweikhardt, Puski and Tang.
We first note that the Examiner's Answer (Paper #16) provides
only a brief referral to the teachings of the references
relied upon in the obviousness rejection and in our opinion
mischaracterizes those teachings. The conclusion of
obviousness is set forth in the Examiner's Answer, from the
paragraph bridging pages 4 and 5 and the first full paragraph
on page 5 as:
In the absence of unexpected results, it
would have been obvious to a person of ordinary
skill in the art, at the time the invention was
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made, to incorporate the enzymes as taught by
Jost et al., Miles (EP'986), Schweikhardt et al.,
Puski et al., and Tang et al. into that of Gaull
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because the use of enzymes in infant formulas
in[sic] conventional in the art.
Applicant is merely using known components
and process steps in order to obtain expected
results, see In re Kerkhoven 205 USPQ 1069 and
In re Gershon 152 USPQ 602.
With respect to claims 24-26 the rejection is silent as
to the enzyme compositions that are set forth in these claims
and how the prior art teachings relate to these compositions.
We are constrained to reverse this rejection with respect to
claims 24-26, in light of the failure of the examiner to
explain which teachings are being relied upon to establish
that these claims would have been obvious over the cited prior
art.
Claims 1-23 require the addition of an enzyme to infant
formulas, however more is required than the mere addition of
enzymes to formula at any stage in production of the formula
or in any form and amount. Claims 1-23 require the enzyme to
be in a "form that will be enzymatically active in the
digestive system of an infant to whom the baby formula is
administered" and further that the enzyme "is present in an
amount effective to completely digest the enzyme substrate in
the formula by the time the substrate reaches the end of the
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colon." The examiner's statement of rejection does not
mention these claim limitations. The statement would lead one
to believe that "the enzymes as taught by Jost et al., Miles
(EP'986), Schweikhardt et al., Puski et al., and Tang et al."
are in a form and quantity such as is required by the claims.
With the exception of Tang this is simply not the case.
Moreover, the enzyme taught by Tang is neither a protease nor
a polysaccharide-degrading enzyme, which all of the claims
require, rather it is a lipase.
Appellant relies upon this aspect of the claims in
arguing for the patentability of the claims at issue. See,
for example, page 13 of the Appeal Brief, the third complete
paragraph ("None of the prior art discloses addition of a
protease or a carbohydrate degrading enzyme to baby formula
which is not removed or inactivated prior to administration of
the formula to the baby."). On page 14 of the Appeal Brief,
in the second paragraph appellant argues that "the prior art
teaches away from the need to add a protease or a carbohydrate
degrading enzyme to a formula where the enzyme is available
following ingestion" due to the fact that the prior art
approach has been to use the enzymes to digest these
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substrates, to then inactivate or remove the enzymes, followed
by administering the pre-hydrolyzed compositions. Both of
these points bear directly on the determination of a prima
facie case of obviousness with respect to claims 1-23.
The examiner has an initial burden of establishing that
one of ordinary skill in the art would have found the claimed
invention to have been obvious at the time that it was made.
The evidence relied upon must support such a conclusion. As
was set forth in In re Vaeck, 947 F.2d 488, 493, 20 USPQ2d
1438, 1442 (Fed. Cir. 1991):
Where claimed subject matter has been rejected
as obvious in view of a combination of prior
art references, a proper analysis under § 103
requires, inter alia, consideration of two
factors: (1) whether the prior art would have
suggested to those of ordinary skill in the
art that they should make the claimed composition
or device, or carry out the claimed process; and
(2) whether the prior art would also have
revealed that in so making or carrying out,
those of ordinary skill would have a reasonable
expectation of success.
Considering the rejection at issue, as is apparent from
the Response to Argument section of the Examiner's Answer, on
pages 5-10, such a proper analysis as is suggested in In re
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11
Vaeck has not been undertaken. On page 6, lines 2-13, of the
Examiner's Answer the examiner's reasoning is stated thus:
The examiner agrees with appellant that the
prior art teaches inactivating the enzyme
after it is used to hydrolyse the protein
of interest. The prior art and the claimed
invention differs in the approach taken; but,
the end result is the same. The claimed
invention keeps the enzyme active so that
it can be used to hydrolyze the protein in
the formula after ingestion while the prior
art teaches the protein is hydrolyze[sic]
before ingestion. Both of these methods
produce a baby formula that is more tolerable
for babies with digestive problem[sic]. Thus,
it would have been obvious for one skilled
in the art to choose one method or the other
with the same expectation of success. The
way to keep the enzyme active would have been
within the skill of one in the art.
The examiner's reliance on a proposition that "the way to
keep the enzyme active would have been within the skill of one
in the art" is misplaced. As explained by the Federal Circuit
in
In re Vaeck, supra, the obviousness of a claimed composition
must be based on the teachings of the applied prior art and
not on whether an artisan of ordinary skill could produce the
claimed compositions from materials known in the prior art.
In this case the prior art contains no suggestion that one
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Application No. 07/885,490
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should make the claimed compositions, containing active
proteases and/or polysaccharide degrading enzymes.
The examiner's reasoning focuses on the similarity of the
end result for the infant that is fed the formula, but does
not explain why one of ordinary skill in the art would have
had a reasonable expectation of success in modifying the prior
art. The fact that the prior art pre-digested the proteins
and polysaccharides might well suggest that the skilled
artisan would
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not have had a reasonable expectation that the same result
would follow from inclusion of enzymes in formula which
contains proteins and polysaccharides, where the enzyme is
active in the digestive system. The contact time between
enzyme and substrate, as well as the reaction conditions, are
controllable in the production settings discussed by the prior
art. The examiner's position does not explain why one of
ordinary skill in the art would have had a reasonable
expectation that the reaction parameters would be met by an
infant's digestive system. Neither the statement of rejection
nor the rebuttal explain the basis for any such reasonable
expectation of success and the prior art does not teach a
process wherein the protein and polysaccharide substrates are
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degraded in the digestive system. The examiner draws no
comparison between the lipase degradation which Tang teaches
as occurring in the digestive system after formula is ingested
and any protease or polysaccharide degradation taking place in
the digestive system.
It is well-established that hindsight shall not form
the basis of a conclusion of obviousness under 35 U.S.C. §
103. “Both the suggestion and the expectation of success must
be founded in the prior art, not in the applicant’s
disclosure.”
In re Dow Chemical Co., 837 F.2d 469, 473, 5 USPQ2d 1529, 1531
(Fed. Cir. 1988). As the Federal Circuit stated in Sensonics,
Inc. v. Aerosonic Corp., 81 F.3d 1566, 1570, 38 USPQ2d 1551,
1554 (Fed. Cir. 1996):
To draw on hindsight knowledge of the
patented invention, when the prior art
does not contain or suggest that knowledge,
is to use the invention as a template for
its own reconstruction - an illogical and
inappropriate process by which to determine
patentability. . . . The invention must be
viewed not after the blueprint has been
drawn by the inventor, but as it would have
been perceived in the state of the art that
existed at the time the invention was made.
[citations omitted]
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In our opinion, the examiner has engaged in impermissible
hindsight in the formulation of the rejection at issue,
particularly with respect to the expectation of success which
must be contained or suggested in the prior art.
For the reasons stated above we fail to find a prima
facie case of obviousness with respect to claims 1-26 based on
the art before us.
New Grounds of Rejection Under 37 CFR § 1.196(b)
Claims 24-26 are rejected under 35 U.S.C. § 102 as
anticipated by Mochizuki.
Mochizuki teaches a purified enzymatic composition which
is extracted from the fermentate of Aspergillus niger and
which comprises protease; polysaccharide degrading enzymes,
such as dextranase, "-amylase and $-amylase; lipase; lactase;
and sucrase. See Mochizuki column 1, line 66 through column
2, line 75. While we recognize that Mochizuki does not teach
"increasing digestibility of non-human milk baby formula"
claims 24-26 are directed to compositions rather than methods
of use and this claim language does not place a further
limitation on the composition. Moreover, the facility to
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increase digestibility of any consumed material which
contained the various substrates of the enzyme composition of
Mochizuki, for example proteins, polysaccharides and fats,
would be an inherent characteristic of the enzyme composition
taught by the reference.
Claims 24-26 are rejected under 35 U.S.C. § 102 as
anticipated by Sipos.
Sipos teaches enzyme compositions for ingestion by a
mammal with an enzyme deficiency which results in a digestive
disorder. See column 1, lines 13-20 of Sipos. The enzymes
contained in the composition are selected from a list of
enzymes that includes proteases; polysaccharide degrading
enzymes, such as amylase; lipase; and lactase, i.e. $-
galactosidase. See Sipos, column 4, line 67 through column 5,
line 46. Sipos teaches that the enzyme compositions are
intended to aid in the digestibility of food. See column 3,
lines 8-15. In any case, the use of the composition to
increase digestibility of a specific food, i.e. non-human milk
baby formula, is not presented as a claim limitation in claims
24-26.
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Application No. 07/885,490
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Claims 24 and 25 are rejected under 35 U.S.C. § 102 as
anticipated by Roy.
Roy teaches a composition which contains lipase, amylase
and protease enzymes. See column 1, lines 29-34 of Roy. Roy
teaches that the enzyme compositions are intended to aid in
the digestibility of food. See column 1, lines 25-29. In any
case, the use of the composition to increase digestibility of
a specific food, i.e. non-human milk baby formula, is not
presented as a claim limitation in claims 24 and 25.
CONCLUSION
The decision of the examiner refusing to allow claims 1-
26 under 35 U.S.C. § 103 is reversed.
Claims 24-26 are newly rejected by the authority of 37
CFR
§ 1.196(b) and under 35 U.S.C. § 102 as anticipated by either
Mochizuki or Sipos.
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Claims 24 and 25 are newly rejected by the authority of
37 CFR § 1.196(b) and under 35 U.S.C. § 102 as anticipated by
Roy.
This decision contains a new ground of rejection pursuant
to 37 CFR § 1.196(b)(amended effective Dec. 1, 1997, by final
rule notice, 62 Fed. Reg. 53,131, 53,197 (Oct. 10, 1997), 1203
Off. Gaz. Pat. & Trademark Office 63, 122 (Oct. 21, 1997)).
37 CFR § 1.196(b) provides that, “A new ground of rejection
shall not be considered final for purposes of judicial
review.”
37 CFR § 1.196(b) also provides that the appellant,
WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new
ground of rejection to avoid termination of proceedings
(§ 1.197(c)) as to the rejected claims:
(1) Submit an appropriate amendment of the
claims so rejected or a showing of facts relating to
the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the
application will be remanded to the examiner. . . .
(2) Request that the application be reheard
under § 1.197(b) by the Board of Patent Appeals and
Interferences upon the same record. . . .
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Application No. 07/885,490
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No time period for taking any subsequent action in
connection with this appeal may be extended under 37 CFR
§ 1.136(a).
REVERSED; 37 CFR § 1.196(b)
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
MICHAEL SOFOCLEOUS ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
ELIZABETH C. WEIMAR )
Administrative Patent Judge )
Appeal No. 95-0523
Application No. 07/885,490
20
Patrea L. Pabst
ARNALL GOLDEN & GREGORY
2800 One Atlantic Center
1201 West Peachtree Street
Altanta, Georgia 30309-3450
ECW/jrg
JENINE GILLIS
Appeal No. 95-0523
Serial No. 07/885,940
Judge WEIMAR

Judge WINTERS

Judge SOFOCLEOUS
Typed: 16 Jul 98
DECISION: REVERSED; 37 CFR §
1.196(b)

Send Reference(s): Yes No
or Translation(s)
Panel Change: Yes No
3-Person Conf. Yes No
Heard: Yes No
Remanded: Yes No
Index Sheet-2901 Rejection(s):
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