Ex parte Lajoie et al.

Board of Patent Appeals and Interferences

May 29, 1998

07662735 (B.P.A.I. May. 29, 1998)

Application for patent filed February 28, 1991.1
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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(2) is not binding precedent of the Board.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 CURTIS LAJOIE and PETER F. STROM
____________
Appeal No. 94-1911
Application 07/662,7351
____________
ON BRIEF
____________
Before WINTERS, WILLIAM F. SMITH, and GRON, Administrative Patent
Judges.
GRON, Administrative Patent Judge.
DECISION ON APPEAL UNDER 35 U.S.C. § 134
1. Introduction
This is an appeal from an examiner’s final rejection of
Claims 5, 6 and 11, all claims pending in this application.
Appeal No. 94-1911
Application 07/662,735
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All claims stand finally rejected under 35 U.S.C. § 112, first
paragraph, as based on a specification which would not have
enabled persons skilled in the art to make and use the full
scope of the claimed invention, and under 35 U.S.C. § 103 as
unpatentable in view of the combined teachings of Drahos et al.
(Drahos), “Tracking Recombinant Organisms in the Environment:
B-Galactosidase as a Selectable Non-Antibiotic Marker for
Fluorescent Pseudomonads,” BIO/TECHNOLOGY, Vol. 4, pp. 439-444
(May 1986); Winter et al. (Winter), “Efficient Degradation
of Trichloroethylene by a Recombinant Escherichia coli,”
BIO/TECHNOLOGY, Vol. 7, pp. 282-285 (Mar. 1989); Sick et al.
(Sick), U.S. 4,996,155, patented February 26, 1991; and Blair,
U.S. 4,483,923, patented November 20, 1984. A new ground of
rejection under 35 U.S.C. § 101 which was entered at pp. 4-5 of
the Examiner’s Answer (Paper # 16) has been withdrawn by the
examiner (Supplemental Examiner’s Answer, p. 1 (Paper # 21)).
Claims 5, 6 and 11 are said to stand or fall together with
Claim 11 under 35 U.S.C. § 112, first paragraph (Brief on Appeal
(Br.), p. 4, first full para.). However, appellants state that
the claims do not stand or fall together under 35 U.S.C. § 103
(Br. 4). The examiner agrees (Examiner’s Answer (Ans.), p. 2).
Claims 11 and 6 represent the methods claimed and read:
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11. The method of microbiologically degrading
organic material in a mixed microbiologically competitive
environment which comprises introducing to said environment
a recombinantly modified microorganism in the presence
of at least one substance not normally utilized by micro-
organisms indigenous to said environment but utilized
as a growth substrate by said recombinantly modified micro-
organism, said recombinantly modified microorganism having
been genetically modified to express upon utilization of
said growth substrate at least one enzyme operable in the
degradation of said organic material.
6. The method according to claim 11 wherein said
substrate is a surfactant.
2. Discussion
In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir.
1992) instructs at 1445, 24 USPQ2d at 1444:
[T]he examiner bears the initial burden, on review of
the prior art or on any other ground, of presenting a
prima facie case of unpatentability.
This burden should be no revelation to examiners. In re Fine,
837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988) teaches at 1074,
5 USPQ2d at 1598:
The PTO has the burden under section 103 to establish a
prima facie case of obviousness. . . . It can satisfy this
burden only by showing some objective teaching in the
prior art or that knowledge generally available to one
of ordinary skill in the art would lead that individual
to combine the relevant teachings of the references.
Moreover, “The first paragraph of § 112 requires nothing more
than objective enablement. . . . How such a teaching is set
forth, either by the use of illustrative examples or by broad
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terminology, is irrelevant.” In re Vaeck, 947 F.2d 488, 496
n.23, 20 USPQ2d 1438, 1444-1445 n.23 (Fed. Cir. 1991).
Accordingly, In re Marzocchi, 439 F.2d 220, 169 USPQ 367 (CCPA
1971) teaches at 223-224, 169 USPQ at 369-370, that statements in
the specification shall be taken as true and will suffice for
objective enablement under 35 U.S.C. § 112, first paragraph,
unless the examiner provides sufficient reasons to doubt the
objective truth of the statements. A finding that the examples
in the specification are not commensurate in scope with the
scope of the subject matter claimed does not itself satisfy the
examiner’s burden to show that the specification as a whole would
not have enabled one skilled in the art to make and use the
claimed invention. The examiner’s doubts why the specification
as a whole would not have been enabling to a person skilled in
the art must be explained and backed by evidence. In re
Marzocchi, 439 F.2d at 224, 169 USPQ at 370.
What have we here? Here, the examiner emphasizes first that
appellants’ specification would not have enabled persons skilled
in the art to recombinantly modify genes of microorganisms (1) to
produce an enzyme operable to degrade a target organic material
present in a mixed microbiologically competitive environment
while utilizing a growth substrate which is not normally utilized
by organisms indigenous to the mixed microbiologically
Appeal No. 94-1911
Application 07/662,735
Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. & Int.2
1986).
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competitive environment, (2) without undue experimentation, and
(3) with reasonable expectation of successfully degrading the
target organic material. We note that the Forman factors2
considered by the examiner at pages 9-11 of the Examiner’s Answer
relate to the facility with which heterologous gene expression
in any microorganism would have been enabled by appellants’
specification. In our view, the examiner’s focus on the question
whether the kind and amount of direction and guidance provided in
appellants’ specification would have enabled persons skilled in
the art to perform the full scope of heterologous gene expression
contemplated by the claims in any microorganism is misplaced.
The claims on appeal are not drawn to methods for recombinantly
modifying microorganisms. Rather, the recombinantly modified
microorganisms to which appellants’ claims refer appear to be
either old or within the artisan’s skill to obtain without undue
experimentation. Appellants expressly state (Reply Brief, pp. 4-
5, bridging para. and p. 5, first full para.; citations omitted):
Once disclosed, Appellants’ invention is so logical
and simple that one has the tendency to say, “Why didn’t
I think of that?” Given a natural site contaminated with
some organic material, one need only start with an
organism which uses a growth substrate not utilized by
the indigenous microorganism in that environment, what
one might call an “uncommon substate”, and insert, by
well-known recombinant techniques, genes producing an
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enzyme which degrades that organic material.
That recombinant technology is not arcane. It is
routine and is practiced by undergraduate students at
the University where one of the co-inventors teaches.
Appellants do not now and never have attempted to claim
some recombinant technique which forecloses all research
in this area. They never have asserted to have found a
new technique for altering microorganisms. They do not
claim some novel DNA, a vector, or any process for
manipulating the genetic makeup of a cell. They claim
only a method of degrading organic material.
It is axiomatic that patent specifications need not teach,
and preferably omit, what is known in the art. Hybritech Inc. v.
Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94
(Fed. Cir. 1986); In re Wands, 858 F.2d 731, 735, 8 USPQ2d 1400,
1402 (Fed. Cir. 1988). Appellants have asked the examiner to
reconsider the patentability of the claims on appeal with the
focal issue being whether persons skilled in the art would have
been able to make and use the claimed method in light of the
description in the specification and the knowledge in the art.
While the claimed method utilizes recombinantly modified
microorganisms which function in the specific manner indicated,
appellants presume that the public has the recombinantly modified
microorganisms in their possession or sufficient knowledge to
make the recombinantly modified microorganisms without undue
experimentation. The examiner clearly has not shown that persons
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skilled in the art are unable to make recombinantly modified
microorganisms which function in the particular manner indicated
in the claims.
The prior art cited by the examiner appears to be consistent
with appellants’ position that their specification would have
objectively enabled the claimed invention. Nevertheless, while
the combined prior art teachings show that persons skilled in the
art had all the information necessary to successfully make and
use the invention claimed, the references do not establish
unpatentability under 35 U.S.C. § 103. It is improper to “pick
and choose among the individual elements of assorted prior art
references[, as the examiner here has done,] to recreate the
claimed invention.” Smithkline Diagnostics, Inc., v. Helena
Labs. Corp., 859 F.2d 878, 887, 8 USPQ2d 1468, 1475 (Fed. Cir.
1988). Rather, the examiner must “show some teaching or
suggestion in the references to support their use in the
particular claimed combination.” Id. In re Dow Chemical Co.,
837 F.2d 469, 5 USPQ2d 1529 (Fed. Cir. 1988) instructs at 473,
5 USPQ2d at 1531:
The consistent criterion for determination of
obviousness is whether the prior art would have
suggested to one of ordinary skill in the art that
this process should be carried out and would have a
reasonable likelihood of success . . . . Both the
suggestion and the expectation of success must be
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founded in the prior art, not in the applicant’s
disclosure.
We have considered the applied prior art teachings jointly
and severably. While we find the sum of all the bits and pieces
of appellants’ claimed method in the collective teachings, we
find no reasonable suggestion that the claimed method should be
carried out and would have a reasonable likelihood of success.
In our view, the examiner’s rejection of Claims 5, 6 and 11
under 35 U.S.C. § 103 on the basis of the combined teachings of
Drahos, Winter, Sick, and Blair results from an impermissible
hindsight reconstruction of the claimed invention. See In re
Gorman, 933 F.2d 982, 987, 18 USPQ2d 1885, 1888 (Fed. Cir. 1991):
It is impermissible . . . simply to engage in a
hindsight reconstruction of the claimed invention,
using the applicant’s [invention] . . . as a template
and selecting elements from references to fill the gaps.
The examiner appears to have added the general teachings of four
references, which more specifically describe separate and
distinct subject matter, into one pot; filtered the general
concepts through a screen constructed from appellants’ disclosure
to find selective concepts; and reassembled the selective
concepts into the method first described by appellants. This is
hindsight, not obviousness within the meaning of 35 U.S.C. § 103.
The Declaration of Curtis A. Lajoie, Ph.D., filed April 23,
1992 (Paper No. 7), was designed to “confirm . . . what is
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disclosed in the . . . application, namely, that non-adaptive
proteins, here the PCB degrading enzymes, can be expressed by
exogenous DNA in a mixed microbiologically competitive
environment in the presence of a selective substrate, here
detergent” (p. 11, final para.) As stated by the examiner, the
Second Declaration of Curtis A. Lajoie, Ph.D., filed June 4, 1993
(Attachment to Paper No. 19), and appellants' arguments and
supporting extrinsic evidence (Paper No. 20, including Exhibits
A, B, and C) “overcome the examiner’s assertion that the
invention is inoperative and therefore lacks utility”
(Supplemental Examiner’s Answer, p. 1 (Paper No. 21)).
The examiner was willing to conclude on the basis of the
limited showing in the specification that the claimed invention
possessed utility under 35 U.S.C. § 101, presumably throughout
its scope. See In re Langer, 503 F.2d 1380, 1391-92, 183 USPQ
288, 297 (CCPA 1974). Thus, it is not clear why that
determination does not also extend to the Section 112 rejection.
Therefore, what remains of the examiner’s rejection under
Section 112 is the merits of the examiner’s argument that a
specification which contains a statement of the claimed
invention, a limited number of prior art citations which reflect
the knowledge and skill in the art, and a limited number of
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Application 07/662,735
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working examples, would not have enabled one skilled in the art
to perform the full scope of the invention claimed because of
the unpredictability and difficulty persons skilled in the art
would have faced in making recombinantly modified microorganisms.
Interestingly, the examiner’s rejection under Section 103 is
based on a similar combination of prior knowledge and skill in
the art even though that rejection is also impermissibly based on
the hindsight.
Accordingly, we reverse the examiner’s rejections of
Claims 5, 6, and 11 under 35 U.S.C. § 112, first paragraph,
and § 103.
REVERSED
Sherman D. Winters )
Administrative Patent Judge )
)
)
)
William F. Smith ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
Teddy S. Gron )
Administrative Patent Judge )
Appeal No. 94-1911
Application 07/662,735
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Bruce M. Collins
Mathews, Woodbridge & Collins, P.A.
100 Thanet Circle - Suite 306
Princeton, New Jersey 08540