Ex Parte MAYR

Board of Patent Appeals and Interferences

Sep 30, 2003

08693052 (B.P.A.I. Sep. 30, 2003)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

Paper No. 38

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ANTON MAYR
__________

Appeal No. 2002-1291
Application No. 08/693,052
__________

ON BRIEF
__________

Before WINTERS, GRIMES, and GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 19-31. Claims 19, 20 and 26 are representative of the
subject matter on appeal, and read as follows:
19. A paramunity inducer comprising a plurality of poxvirus
components obtainable from different poxvirus strains with
paramunizing properties, wherein the poxvirus are selected from
the group of genera consisting of avipoxvirus, orthopoxvirus and
parapoxvirus.

20. The paramunity inducer according to claim 19, wherein the
poxvirus components are poxviruses.

26. The paramunity inducer according to claim 20, wherein the
poxviruses are freshly isolated.
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The examiner relies upon the following references:
Mayr et al. (Mayr I) 5,094,850 Mar. 10, 1992
Mayr et al. (Mayr II), “Bekaempfung des Ecthyma contagiosum
(Pustular dermatitis) der Schafe mit einuem neuen Parenteral-
Zellkultur-Lebendimpfstoff,” (Translated Title: “Fight against
Ecthyma Contagiosum (Pustular Dermatitis) in Sheep with a New
Parental Cell Culture Live Vaccine.”) Zbl. Vet. Med. B, vol. 28, pp.
535-552 (1981).

Claims 19-31 stand rejected under 35 U.S.C. § 112, first paragraph, on
the grounds that the specification fails to enable the full scope of the claimed
subject matter. Claims 19, 20, 21, 27 and 28 stand rejected under 35 U.S.C. §
102(b) as being anticipated by Mayr II. Finally, claims 23, 24 and 30 stand
rejected under 35 U.S.C. § 103(a) over the combination of Mayr II and Mayr I.
After careful review of the record and consideration of the issues before us, we
affirm the rejection under 35 U.S.C. § 102(b), but reverse the rejections under 35
U.S.C. § 112, first paragraph and 35 U.S.C. § 103(a).
BACKGROUND
The specification states that the immune system of warm-blooded
animals, especially those of mammals and birds, consists of an antigen-specific
and an antigen non-specific portion. According to the specification, the antigen
non-specific portion is responsible for building up paramunity, and that it is the
paraspecific immune system that allows an organism to mount an immediate
defense when confronted by a foreign substance. See Specification, page 1.
The specification acknowledges that poxviruses are known paramunity inducers
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that “can positively influence the organism’s ability to resist infections and
tumors, on a non-specific level.” Id. at 2.
The invention is drawn to “multipotent paramunity inducers based on a
combination of two or more poxvirus components derived from various poxvirus
strains having paramunizing properties.” Id. at 3. As set forth in the
specification:
The term “poxvirus component”, as employed in the context
of this invention, covers a large number of viral structures derived
from poxviruses with paramunizing properties, for example viable
(i.e. capable of multiplication) or inactivated freshly isolated
poxviruses, viable or inactivated recombined poxviruses derived
from freshly isolated poxviruses, viable or inactivated attenuated
poxviruses, viable or inactivated recombined poxviruses derived
from attenuated poxviruses, the detached envelopes and cleavage
products and aberrant forms of said envelopes of the poxviruses
listed above, individual viral polypeptides obtained by biochemical
or immunochemical methods from cultures that had been infected
with the poxviruses listed above, and recombinant viral
polypeptides obtained by means of prokaryotic or eukaryotic
expression and at least parts of which are derived from one or
more of the polypeptides of the poxviruses listed above.

Id. at 5.
The specification asserts that the multipotent paramunity inducers of the
invention have virtually no immunogenic properties, but have strong
paramunizing properties. The specification observes:
a) Attenuation over several hundred passages in cell cultures
causes the immunizing properties of poxviruses to decrease,
whilst the paraspecific activities not only increase but in the
case of certain pox strains only appear after attenuation;

b) inactivation of the poxviruses suited to the preparation of the
paramunity inducers, preferably by irradiation, heat or pH
action, or most preferably by chemical treatment with β-
propiolactone under specific conditions, causes the poxviruses
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to lose their immunizing properties whereas their paramunizing
activities increase.

Id. at 4-5.
DISCUSSION
1. 35 U.S.C. § 112, First Paragraph
Claims 19-31 stand rejected under 35 U.S.C. § 112, first paragraph, on
the grounds that the
specification, while being enabling for compositions comprising
combinations of the attenuated poxvirus strains HP-1, ORF D1701,
MVA, and KP-1, does not reasonably provide enablement for any
and all paramunity inducers comprising a plurality of poxvirus
components obtainable from different poxvirus strains with
paramunizing properties that are encompassed by the claims. The
specification does not enable any person skilled in the art to which
it pertains, or with which it is most nearly connected, to make and
use the invention commensurate in scope with these claims.

Examiner’s Answer, pages 3-4.
According to the rejection, the claims encompass any portion of the
poxviruses, up to and including recombinant poxviruses and freshly isolated
virulent poxviruses. The rejection acknowledges that “[w]hile it may be so that
techniques that are known and conventional can be used to test for the desired
properties, the instant specification does not describe single poxvirus
components other than attenuated poxvirus that have paramunizing properties.”
Id. at 4.
The rejection concludes:
Taking into account the scope of the claims, the amount of
guidance provided, the extent of the written description, the state of
the art at the time the invention was made, and the lack of
predictability in the area of immunology in general and viral
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immunity in particular, it would require undue experimentation for
one of ordinary skill in the art to practice the invention throughout
the scope of the claims.

Id.
Appellant argues, relying on the statement of the examiner that
techniques are known in the art to test for compositions having the desired
properties, that it would not require an undue amount of experimentation by one
skilled in the art to practice the claimed invention. Appeal Brief, pages 8-9. We
agree, and therefore reverse the rejection.
The examiner bears the initial burden of showing nonenablement. See In
re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
“[E]nablement requires that the specification teach those in the art to make and
use the invention without ‘undue experimentation.’ . . . That some
experimentation may be required is not fatal; the issue is whether the amount of
experimentation required is ‘undue.’” In re Vaeck, 947 F.2d 488, 495, 20
USPQ2d 1438, 1444 (Fed. Cir. 1991) (emphasis in original). Some
experimentation, even a considerable amount, is not “undue” if, e.g., it is merely
routine, or if the specification provides a reasonable amount of guidance as to
the direction in which the experimentation should proceed. See In re Wands,
858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The primary concern of the examiner appears to be breadth of the claims.
The examiner admits, however, that “it may be so that techniques that are known
and conventional can be used to test for the desired properties,” thus the
examiner has not met the burden of demonstrating that it would require an
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undue amount of experimentation to practice the full scope of the claimed
subject matter. Moreover, the fact that the claims may encompass inoperative
embodiments does not render them non-enabled. See Atlas Powder Co. v. E.I.
Du Pont De Nemours & Co., 750 F.2d 1569, 1576, 224 USPQ 409, 413 (Fed.
Cir. 1984), In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 218 (CCPA
1976).
2. 35 U.S.C. § 102(b)
Claims 19, 20, 21, 27 and 28 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Mayr II. Claim 19 is treated as the representative claim, as
the claims stand or fall together. See Appeal Brief, page 7.
According to the rejection:
Mayr [II] disclose[s] administering the combination of ORF virus
strain D1701, attenuated by 135 passages in secondary cell
cultures of embryonic sheep kidneys and subsequently grown in
bovine embryo lung cells (see the Summary, page 550), and the
paramunity inducer DUPHAMEN®, which is disclosed in the instant
specification as being attenuated avipox virus strain HP-1, as a
sheep vaccine (see the Summary, page 550, pages 545-546 and
the Abstract, for example.) Although it is recognized that Mayr [II]
administered the ORF virus D1701 for the purpose of inducing
specific immunity in sheep, and administered it in combination with
a paramunity inducer, the composition of Mayr [II] is deemed to
anticipate the claimed composition since it combines two of the
same poxvirus strains that are encompassed by the instant claims
and that are specifically recited in claim 21, regardless of the
purpose for which Mayr [II] intended it or the reason Mayr [II]
combined the two strains. The specification at page 9 describes
procedures for attenuation of ORF virus D1701 for use as a
paramunity inducer that reasonably appear to be equivalent to the
attenuation procedures described by Mayr [II]; further, the
specification at page 4, lines 24-28, points out that attenuation by
multiple passages in cell cultures causes immunizing properties to
decrease and paramunizing properties to increase. Consequently,
the claim limitations are met by the combination of attenuated ORF
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virus strain D1701 and DUPHAMEN®, which is attenuated avipox
virus strain HP-1, as taught by Mayr [II].

Examiner’s Answer, pages 7-8.
Appellant argues that Mayr II teaches the combination of a vaccine, the
ORF virus D1701, and a paramunity inducer, Duphamun®, and thus the ORF
virus strain used in Mayr II cannot be considered as having paramunizing
properties as it is used only in vaccinating the animals. Therefore, appellant
asserts, Mayr II cannot anticipate the claims, as it does not teach a paramunizing
composition comprising a plurality of poxvirus components. See Appeal Brief,
page 11. Appellant contends that the poxvirus components of the present
invention have lost their immunizing properties. See Appeal Brief, page 12.
Finally, appellant notes that the European Patent Office issued a patent after
considering the Mayr II reference.
We acknowledge that in order for a prior art reference to serve as an
anticipatory reference, it must disclose every limitation of the claimed invention,
either explicitly or inherently. See In re Schreiber, 128 F.3d 1473, 1477, 44
USPQ2d 1429, 1432 (Fed. Cir. 1997). But as noted by the examiner, claim 19 is
drawn to a composition, and Mayr II teaches a composition that reads on the
claimed composition, i.e., a composition comprising the parapox virus ORF
D1701 and the avipox pox virus HP-1. “[W]hen the PTO shows sound basis for
believing that the products of the applicant and the prior art are the same, the
applicant has the burden of showing that they are not.” In re Spada, 911 F.2d
705, 708, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). “When the claimed
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compositions are not novel they are not rendered patentable by recitation of
properties, whether or not these properties are shown or suggested in the prior
art.” Id. at 709, 15 USPQ2d at 1658.
Thus appellant’s argument that the ORF D1701 cannot be considered as
having paramunizing properties is not convincing, as no evidence has been
presented to support that assertion, and arguments of counsel cannot take the
place of evidence in the record. See in re Scarbrough, 500 F.2d 560, 566, 182
USPQ 298, 302 (CCPA 1974); In re DeBlauwe, 736 F.2d 699, 705, 222 USPQ
191, 196 (Fed. Cir. 1984). Moreover, although attenuated viruses that no longer
virulent may be preferred, see Specification, page 8, the specification specifically
states that “poxvirus species may be used as freshly isolated, so-called virulent
field strains,” id. Thus, there is nothing in the specification or the claims that
limits the poxvirus components to those components that have no immunizing
properties.
Appellant argues further that “[t]here is an essential difference in the
timing of the effect of an immunizing and paramunizing element,” as well as “an
essential difference in the preparation of a paramunizing component, rather than
an immunizing one.” Appeal Brief, page 12.
That argument is also not convincing, as claim 19 is drawn to a
composition, not a method, and appellant is arguing method limitations.
Appellant argues further that the composition of the present invention has
superior effects as compared to a single paramunity inducer. Specifically,
appellant states that the effect of the claimed paramunity inducer (Conpind)
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exceeded that of the components Duphapind® and Baypamun®. See Appeal
Brief, pages 14-15. Unexpected results, however, cannot be used to overcome
a rejection under 35 U.S.C. § 102(b) for anticipation. See In re Wiggins, 488
F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1978).
3. 35 U.S.C. § 103(a)
Claims 23, 24 and 30 stand rejected under 35 U.S.C. § 103(a) as being
obvious over the combination of Mayr II with Mayr I.
Mayr II is relied upon as set forth above. The rejection acknowledges that
Mayr II does not specifically describe inactivation of the described viral strains.
Mayr II is relied upon for its description of the inactivation of poxvirus strains that
are intended to induce non-specific immunity. The rejection concludes:

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It would have been obvious to one of ordinary skill in the art at the
time the invention was made to inactivate poxviruses of Mayr [II] as
taught by [Mayr I] for expected equivalent function because [Mayr I]
discloses inactivated poxviruses of different strains encompassed
by the instant claims.

Examiner’s Answer, page 8.
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial
burden of presenting a prima facie case of obviousness. Only if that burden is
met, does the burden of coming forward with evidence or argument shift to the
applicant.” In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956 (Fed. Cir.
1993). The test of obviousness is “whether the teachings of the prior art, taken
as a whole, would have made obvious the claimed invention.” In re Gorman, 933
F.2d 982, 986, 18 USPQ2d 1885, 1888 (Fed. Cir. 1991). In addition, there must
be some motivation, teaching or suggestion to combine the references to arrive
at the claimed invention. See In re Lee, 277 F.3d 1338, 1342-43, 61 USPQ2d
1430, 1433-34 (Fed. Cir. 2002)
Claims 23 and 24 add the limitation that “the poxviruses are inactivated,”
and claim 30 adds the limitation that “the poxvirus strains are inactivated.” We
interpret those limitations as requiring all of the poxvirus components of the
composition to be from inactivated poxviruses.
As acknowledged by the rejection, Mayr I teaches a process for the
inactivation of poxvirus strains that are intended to induce non-specific immunity.
Mayr II, however, teaches a composition comprising an antigen for activating a
specific immune response, i.e., the ORF virus D1701, as well as a component for
inducing a paramunity response, i.e., DUPHAMEN®. While the combination may
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teach or suggest a composition comprising a paramunizing component derived
from an inactivated poxvirus, the rejection fails to provide a teaching, suggestion,
or motivation to inactivate the non-paramunizing component, and thus the
combination fails to set forth a prima facie case of obviousness and is reversed.
CONCLUSION
Because the examiner has not set forth a prima facie case of
unpatentability, the rejections under 35 U.S.C. § 112, first paragraph, and 35
U.S.C. § 103(a) are reversed. But because Mayr II teaches all of the
components of the claimed composition, the rejection under 35 U.S.C. § 102(b)
is affirmed.
No time period for taking any subsequent action in connection with this
appeal may be extended under 37 CFR § 1.136(a).
AFFIRMED-IN-PART; REVERSED-IN-PART

)
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
ERIC GRIMES )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
LORA M. GREEN )
Administrative Patent Judge )

Appeal No. 2002-1291 Page 12
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