Ex parte Tamura

Board of Patent Appeals and Interferences

May 31, 2000

08041428 (B.P.A.I. May. 31, 2000)

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(2) is not binding precedent of the Board.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. 24
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte KEIJI TAMURA
____________
Appeal No. 1996-0111
Application No. 08/041,428
____________
HEARD: May 18, 2000
____________
Before WINTERS, ROBINSON, and ADAMS, Administrative Patent Judges.
ROBINSON, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal from the examiner's final rejection of claims 1-26,
which are all of the claims pending in this case. Independent claims 1 and 25 are
illustrative of the subject matter on appeal and read as follows:
1. A method for controlling the health of a group of animals and maintaining the
group of animals in a condition of optimum health to maximize the productivity of the
animals in the group, comprising the steps of
Appeal No. 1996-0111
Application 08/041,428
2
(a) quantitatively determining the normal upper limit for the " -acid1
glycoprotein value in a selected body fluid for normal healthy animals of the kind in the
group;
(b) measuring the " -acid glycoprotein values in said selected body fluid of1
the animals in the group;
(c) comparing the measured " -acid glycoprotein values obtained in step1
(b) to the normal upper limit determined in step (a);
(d) identifying the animals in the group with " -acid glycoprotein values that1
exceed said normal upper limit;
(e) using the information obtained in step (d) to assess the relative health of
the animals in the group; and
(f) based upon the assessment of step (e), taking the action required to
promote and maintain the optimum health of the animals in the group, thereby maximizing
the productivity of the animals in the group.
25. A method for maintaining a herd of animals assembled from different
sources in a condition of optimum health and homeostatic balance, said herd being
composed of one type of animals selected from the group consisting of veal calves, pigs
and cattle, wherein said herd is maintained in a condition of optimum health and
homeostatic balance by measuring the " -acid glycoprotein values in a selected body 1
fluid of the animals, comparing the measured " -acid glycoprotein values to a normal1
upper limit for " -acid glycoprotein for the selected body fluid in the type of animals in the1
herd, identifying individual animals with " -acid glycoprotein values that exceed said1
normal upper limit, using the measured " -acid glycoprotein values to assess the relative1
health and homeostatic balance of the herd, and taking the action required to promote and
maintain the health and homeostasis balance of the herd.
The references relied upon by the examiner are:
Ruhenstroth-Bauer et al. (Ruhenstroth-Bauer) 4,215,109 July 29, 1980
Shell et al. (Shell) 4,492,753 Jan. 8, 1985
Fudenberg 4,801,533 Jan. 31, 1989
Appeal No. 1996-0111
Application 08/041,428
3
Toyama et al. (Toyama) EP 0 199 196 Oct. 29, 1985
Belpaire et al. (Belpaire), "" -Acid Glycoprotein and Serum Binding of Drugs in Healthy1
and Diseased Dogs," J. Vet. Pharmacol. Therap., vol. 10, pp. 43-48 (1987).
Tamura et al. (Tamura I), "Isolation, Characterization, and Quantitative Measurement of
Serum " -Acid Glycoprotein in Cattle," Japanese J. Vet. Sci., vol. 51(5), pp. 987-9941
(1989).
Tamura et al. (Tamura II), "Measurement and Significance of Proteins in Cow's Milk,
Japanese J. of Vet. Sci., vol. 110, page 279 (1990).
Itoh et al. (Itoh), "Serum " -Acid Glycoprotein in Cattle with Inflammatory Disease and that1
after Operation," Japanese J. Vet. Sci., vol. 52(6), pp. 1293-1296 (1990).
GROUNDS OF REJECTION
Claims 1-26 stand rejected under 35 U.S.C. § 103. As evidence of obviousness,
the examiner relies upon Fudenberg, Toyama, Shell, Ruhenstroth-Bauer, and Belpaire.
Claims 25-26 stand rejected under 35 U.S.C. § 103. As evidence of obviousness,
the examiner relies upon Tamura I, Tamura II, and Itoh.
Background
At pages 1 and 7 of the Specification, applicant describes the invention as relating
to a method which provides an effective, accurate and objective method for measuring the
" -acid glycoprotein (AGP) levels in the body fluids of different types of animals as an1
objective indication of the relative health and/or homeostatic balance of individual animals
or a group of animals to provide a basis for effective animal management.
Appeal No. 1996-0111
Application 08/041,428
4
Discussion
The rejections under 35 U.S.C. § 103
In considering the issues raised by this appeal, we have considered the Examiner's
Answer, the Supplemental Answer, the references relied on by the examiner, Appellant's
Brief and Reply Brief, the declarations of Dr. Brown and Dr. Coffey, as well as the record
as a whole.
Claims 1-26:
The examiner has cited references establishing a correlation between increased
levels of " -acid glycoprotein in the body fluids of humans (Fudenberg, Toyama, and1
Shell), rats (Ruhenstroth-Bauer) and dogs (Belpaire) and the presence in the animals of
certain disease or inflammatory conditions as compared to healthy animals. (Answer,
pages 5-6). While acknowledging that none of the references disclose "using these
correlations as a basis for managing farm animals or experimental animals" (Answer,
page 6), the examiner concludes that (Answer, pages 6-7):
it would have been obvious to one of ordinary skill to use the widely available
knowledge that increased " -AGP levels are indicative of disease or1
inflammation to assess the health status of groups of animals and to take
whatever action is necessary in order to diagnose the suspected condition
and subsequently to treat the condition in order to save the diseased animal
or to separate the affected animals from the healthy ones in order to prevent
contagion.
Appeal No. 1996-0111
Application 08/041,428
5
If we step back for a moment and view the prior art relied upon by the examiner in
the absence of applicant's disclosure and claims, we find, as acknowledged by the
examiner, that there is nothing in the prior art which would reasonably suggest to one of
ordinary skill in this art to take the information provided by the references regarding the
presence of elevated levels of " -AGP in diseased animals and use it in a diagnostic1
method for evaluating the relative health within a group of animals and used this
information in animal management as presently claimed.
As stated by appellants (Principal Brief, page 10):
The animal management methods described in the pending claims require a series of
specifically stated steps for controlling and maintaining a population of animals in a
condition of optimum health to maximize productivity and insure commercial marketability,
for evaluating the health profile of animal groups and for maintaining the quality of products
at an acceptable level. Neither the cited references themselves nor the knowledge
generally available to those skilled in the art at the time [sic, of] the present invention was
made contains any suggestion whatever of the animal management methods described in
Appellant's claims.
It is the initial burden of the patent examiner to establish that claims presented in an
application for patent are unpatentable. In re Oetiker, 977 F.2d 1443, 1446, 24 USPQ2d
1443, 1445 (Fed. Cir. 1992). In order to meet the burden of establishing a prima facie
case of unpatentability of the claimed subject matter the examiner must establish that there
is a reason, based on the prior art, or knowledge generally available in the art, as to why it
would have been obvious to one of ordinary skill in the art to arrive at the claimed invention.
Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 297 n.24, 227 USPQ
Appeal No. 1996-0111
Application 08/041,428
6
657, 667 n.24 (Fed. Cir. 1985). On the record before us, the examiner has failed to
provide any factual evidence which would have suggested the use of the correlation of the
levels of " -AGP in animals to certain specific disease conditions in diagnostic methods1
for determining the presence of a disease condition in a group of animals, the use of such
diagnostic methodology in a method of controlling the health of a group of animals, or
maintaining the group of animals in a condition of optimum health as claimed. Thus, we
find that as to this rejection the examiner has failed to establish a prima facie case of
obviousness within the meaning of 35 U.S.C. § 103.
Where, as here, the examiner fails to establish a prima facie case, the rejection is
improper and will be overturned. In re Fine, 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598
(Fed. Cir.1988). Therefore, the rejection of claims 1-26 under 35 U.S.C. § 103 as
unpatentable over Fudenberg, Toyama, or Shell taken in view of Ruhenstroth-Bauer and
Belpaire is reversed.
Claims 25-26:
In considering the issues raised by the rejection of claims 25-26 under 35 U.S.C. §
103 as unpatentable over Tamura I, Tamura II and Itoh, we must first review the examiner's
holding that the subject matter of claims 25-26 is not entitled to the effective filing date of
the parent application and that therefore Tamura I, Tamura II and Itoh constitute prior art
with regard to these claims.
Appeal No. 1996-0111
Application 08/041,428
7
It is the examiner's position that the terminology and concept encompassed by the
claim limitation of "homeostasis" was not disclosed in the parent application and that
therefore claims 25-26 are not entitled to the benefit of the filing date of the parent
applications under the provisions of 35 U.S.C. § 120. (Answer, page 11).
Citing the Declaration of Dr. Brown as supporting evidence, appellant argues that
"the term 'optimum health', found by the Examiner to be supported by the original parent
case . . . encompasses 'homeostasis' as that term is commonly used and understood in
the art" and further that "the term 'homeostasis', which was used in combination with
'optimum health' for emphasis rather than to designate a new and different concept, might
be fairly deduced from the original disclosure by one skilled in the animal management
art.” (Principal Brief, page 17-18)
However, as our appellate court stated in Lockwood v. American Airlines Inc., 107
F.3d 1565, 1571, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997):
It is the disclosures of the applications that count. Entitlement to a filing date
does not extend to subject matter which is not disclosed, but would be
obvious over what is expressly disclosed. It extends only to that which is
disclosed. While the meaning of terms, phrases, or diagrams in a disclosure
is to be explained or interpreted from the vantage point of one skilled in the
art, all the limitations must appear in the specification. The question is not
whether a claimed invention is an obvious variant of that which is disclosed
in the specification. Rather, a prior application itself must describe an
invention, and do so in sufficient detail that one skilled in the art can clearly
conclude that the inventor invented the claimed invention as of the filing date
sought. (Citation omitted).
Appeal No. 1996-0111
Application 08/041,428
The designation "AG", as used in Tamura I, Tamura II, and Itoh, represents " -1-1
acid glycoprotein. See Tamura I at page 987, line 1 of the Abstract.
8
Having reviewed the disclosure of the parent applications, we find no description
within the meaning of 35 U.S.C. § 112, first paragraph, of the concept of homeostasis or
homeostatic balance. Further, the use of the terminology "homeostasis" and "optimum
health" at pages 2-3 of the present specification suggests that they are more reasonably
intended to refer to alternative aspects of health rather than, as urged by appellant, a
situation where homeostasis is merely encompassed within the concept of optimum
health. Therefore, we find no error in the examiner's determination that claims 25-26 are
entitled to the filing date of the current application as the effective filing date. Thus, we
agree with the examiner that Tamura I, Tamura II, and Itoh constitute prior art as to these
claims.
In sitting forth the basis of the rejection of claims 25-26 the examiner cites Tamura I
as teaching (Answer, page 11):
purification of bovine " -AGP and raising antisera for use in a single radial1
immunodiffusion assay. Tamura further discloses elevated serum " -AGP1
in animals with various conditions, e.g., see p[age] 933: "The amount of
circulating " -AG also seems to correlate with the extent of the disease ... 1
1
Therefore, quantitative measurement of serum " -AG in cattle may be a1
useful aid in monitoring the course of various diseases ... Furthermore,
increases in " -AG without apparent diseases may indicate sub-clinical1
pathological conditions."
Appeal No. 1996-0111
Application 08/041,428
9
Similarly, the examiner cites Tamura II as teaching alterations in " -AGP in diseased1
cattle following treatment with antibiotics and upon reappearance of the disease condition.
(Answer, page 12). The examiner states that Itoh discloses (Answer,
page 12):
changes in " -AGP in cattle with inflammatory diseases and after surgical1
operations and also discloses that effective treatment of inflammatory
diseases with antibiotics was correlated with return of the " -AGP level to1
normal.
The examiner concludes that (id.):
it would have been obvious to one of ordinary skill in the art to measure and
monitor " -AGP in the body fluids of animals including cattle in order to1
assess the animals’ health as taught by Tamura (1) or Tamura (2) or Itoh
because each reference teaches both methods for measurement and the
value of monitoring the " -AGP in body fluid samples in animals such as1
cattle.
Appellant's only argument as to whether Tamura I, Tamura II, and Itoh are sufficient
to establish a prima facie case of obviousness is that (Principal Brief, page 19):
these publications arguably give some general guidance and may suggest
exploration of the claimed animal management method. However, their
teachings are not sufficiently specific to lead one of ordinary skill in the art to
the claimed method. Simply because a method is arguably "obvious to try"
does not make an invention obvious.
We do not agree that Tamura I, Tamura II and Itoh merely provide general guidance
which might suggest exploration of the claimed animal management method. The
references each describe the identification of diseased animals, the treatment and
monitoring of the animals as the disease condition is treated by monitoring the " -AGP1
Appeal No. 1996-0111
Application 08/041,428
10
levels in the animal. Of particular relevance is that portion of Tamura I at page 992, column
2, first full paragraph which states:
the serum levels of . . . mucoproteins in cattle with hepatic abscess were
much higher than those of healthy controls, and pointed out that the
measurements of these serum markers were useful for determination of the
prognosis of cattle with inflammatory diseases and also for monitoring the
effectiveness of therapy.
Tamura I also suggests at page 993, column 1, second full paragraph that the evaluation of
serum " -AG levels may provide a useful markers for the screening for various1
abnormality. Similarly, Tamura II in the last paragraph of the translation would reasonably
appear to describe the determination of the level of " -AGP in normal healthy cattle's milk,1
compares this with the level of " -AGP in cattle with mastitis, monitors the decrease to1
normal levels of this elevated level of " -AGP after treatment with antibiotics, notes that the1
elevated levels reappeared upon reappearance of mastitis and concludes that "it is
significant to measure AGP . . . in milk in order to track or observe the mastitis treatment."
Itoh also states (page 1296, column 1, last paragraph):
Those results suggest that serum " -AG level in recovered cases was not1
increased, while it was high in unrecovered cases. As an indicators for the
diagnosis of inflammatory disease, the assay of serum " -AG seemed to be1
very useful for evaluation of an appropriate treatment and of condition of
postoperative course in cattle.
Thus, these references reasonably appear to describe a process for monitoring or
managing a group of animals, including cattle, where the normal levels of " -AGP of1
healthy animals is determined, the AGP levels are monitored in diseased animals, and this
Appeal No. 1996-0111
Application 08/041,428
11
serum marker is used as an diagnostic tool for evaluating the health of animals within the
group in order to permit the treatment of the animals identified as having a diseased
condition. On this record, the examiner's reasoning, supported by the facts and evidence
presented, are sufficient to establish a prima facie case of unpatentability as to the
claimed subject matter.
Having weighed appellant's arguments and evidence against the evidence in favor
of unpatentability, we agree with the examiner's determination that Tamura I, Tamura II and
Itoh are sufficient to establish a prima facie case of unpatentability as to the claimed
subject matter which is not overcome by either arguments or convincing evidence. We,
therefore, affirm the rejection of claims 25-26 under 35 U.S.C. § 103.
Summary
The rejection of claims 1-26 under 35 U.S.C. § 103 over the combination of
Fudenberg, Toyama, Shell, Ruhenstroth-Bauer, and Belpaire is reversed. The
rejection of claims 25-26 under 35 U.S.C. § 103 over the combination of Tamura I, Tamura
II, and Itoh is affirmed.
No period for taking any subsequent action in connection with this appeal may be
extended under 37 CFR § 1.136(a).
Appeal No. 1996-0111
Application 08/041,428
12
AFFIRMED-IN-PART
Sherman D. Winters )
Administrative Patent Judge )
)
)
)
Douglas. W. Robinson ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
Donald E. Adams )
Administrative Patent Judge )

Joan K. Lawrence
Sixby, Friedman, Leedom & Ferguston
2010 Corporate Ridge, Ste. 600
Mclean, VA 22102
DR/dm