Ex parte Miyada et al.

Board of Patent Appeals and Interferences

Jul 31, 2000

08487946 (B.P.A.I. Jul. 31, 2000)

The final rejection rejects claims 5-9, 40, however, appellants point out that claim1
40 was canceled at the time of filing of the present application and believe that the
rejection is applied to claim 39 instead of claim 40. Appeal Brief, page 2. See also
Paper No. 4, page 2, referencing claim 39.
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for publication in a law journal and (2) is not binding precedent of the Board.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. 13
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte CHARLES G. MIYADA,
ARTHUR C. SWITCHENKO, MELANIE W. QUONG
and MAN-YING L. WONG
__________
Appeal No. 1997-3378
Application 08/487,946
__________
ON BRIEF
__________
Before WILLIAM F. SMITH, SCHEINER, and MILLS, Administrative Patent Judges.
MILLS, 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 5-9, 40 [sic 39], 41 and 42. Claims 41 and 42 have been 1
withdrawn from consideration by the examiner in Paper No. 7, mailed July 11, 1996.
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Application 08/487,946
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We reverse.
Claim 5 is illustrative of the claims on appeal and reads as follows:
5. A method for determining D-arabinitol, which method comprises the steps
of:
providing in combination (1) a medium suspected of containing
D-arabinitol and (2) a D-arabinitol dehyrogenase enzyme, said enzyme being capable of
catalyzing the oxidation of D-arabinitol and substantially incapable of catalyzing the
oxidation of D-mannitol, and
examining said medium for a product produced as a result of said oxidation
of said D-arabinitol.
OPINION
In reaching our decision in this appeal, we have given careful consideration to the
appellants’ specification and claims, to the applied prior art references, and to the
respective positions articulated by the appellants and the examiner.
Rather than reiterate the conflicting viewpoints advanced by the examiner and the
appellants regarding the above-noted rejection, we make reference to the examiner's
answer (Paper No. 12, February 26, 1997) for the examiner's complete reasoning in
support of the rejection, and to the appellants’ brief (Paper No. 10, December 16, 1996)
for the appellants’ arguments thereagainst. As a consequence of our review, we make the
determinations which follow.
DECISION ON APPEAL
Claims 5-9 and 39 stand rejected under 35 U.S.C. § 112, first paragraph for failing
to provide an enabling disclosure. An analysis of whether the claims under appeal are
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Application 08/487,946
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supported by an enabling disclosure requires a determination of whether that disclosure
contained sufficient information regarding the subject matter of the appealed claims as to
enable one skilled in the pertinent art to make and use the claimed invention. In order to
establish a prima facie case of lack of enablement, the examiner must provide a
reasonable explanation as to why the scope of protection provided by a claim is not
adequately enabled by the disclosure. In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d
1510, 1513 (Fed. Cir. 1993); In re Morehouse, 545 F.2d 162, 165, 192 USPQ 29, 32
(CCPA 1976). The threshold step in resolving this issue is to determine whether the
examiner has met his burden of proof by advancing acceptable reasoning inconsistent with
enablement.
Factors to be considered by the examiner in determining whether a disclosure
would require undue experimentation have been summarized by the board in Ex parte
Forman, 230 USPO 546, 547 (Bd. Pat. App. & Int. 1986). They include (1) the quantity of
experimentation necessary, (2) the amount of direction or guidance presented, (3) the
presence or absence of working examples, (4) the nature of the invention, (5) the state of
the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability
of the art, and (8) the breadth of the claims. (footnote omitted). In re Wands, 858 F.2d 731,
737, 8 USPQ2d 1400, 1404, (Fed. Cir. 1988).
In our opinion, the examiner has failed to set forth a prima facie case of lack of
enablement. It is the examiner’s position that the disclosure is only enabling for claims
directed to a method employing the particular isolated D-arabinitol dehydrogenase
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(DADH) enzyme, isolated from a specific Candida species, as disclosed in the
specification. The examiner suggests that the appellants have not described or
characterized any other enzymes with these characteristics nor have they demonstrated,
convincingly, how the skilled artisan would find or isolate or use other enzymes.
Examiner’s Answer pages 2-3.
Such a broad allegation by the examiner that the disclosure is speculative, coupled
with a recitation of various difficulties which might be encountered in practice, is not
sufficient basis for requiring proof of operability. In re Chilowsky, 229 F.2d 457, 463, 108
USPO 321, 326 (CCPA 1956). It does not reasonably appear that the examiner has
advanced acceptable reasoning, specific argument or other form of evidence which would
support the proposition that one of ordinary skill in the art would find the specification
inconsistent with enablement. The examiner has not provided a reasoned analysis
indicating that the factors set forth in Ex Parte Forman have been considered in a
meaningful way to establish a prima facie case of enablement.
In considering the enablement rejection before us for review, we find the following
passage from PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564, 37 USPQ2d
1618, 1623 (Fed. Cir. 1996) to be instructive.
In unpredictable art areas, this court has refused to find broad generic claims
enabled by specifications that demonstrate the enablement of only one or a
few embodiments and do not demonstrate with reasonable specificity how to
make and use other potential embodiments across the full scope of the
claim. See, e.g., In re Goodman, 11 F.3d 1046, 1050-52, 29 USPQ2d
2010, 2013-15 (Fed. Cir. 1993); Amgen, Inc. v. Chugai Pharmaceutical Co.,
927 F.2d. 1200, 1212-14, 18 USPQ2d 1016, 1026-28 (Fed. Cir.), cert.
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denied, 502 U.S. 856 (1991); In re Vaeck, 947 F.2d at 496, 20 USPQ2d at
1445. Enablement is lacking in those cases, the court has explained,
because the undescribed embodiments cannot be made, based on the
disclosure in the specification, without undue experimentation. But the
question of undue experimentation is a matter of degree. The fact that some
experimentation is necessary does not preclude enablement; what is
required is that the amount of experimentation “must not be unduly
extensive.” Atlas Powder Co., v. E.I. DuPont De Nemours & Co., 750 F.2d
1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984). The Patent and
Trademark Office Board of Appeals summarized the point well when it
stated:
The test is not merely quantitative, since a considerable
amount of experimentation is permissible, if it is merely
routine, or if the specification in question provides a
reasonable amount of guidance with respect to the direction in
which the experimentation should proceed to enable the
determination of how to practice a desired embodiment of the
invention claimed. Ex parte Jackson, 217 USPQ 804, 807
(1982).
In addition, the examiner has failed to fully address the rebuttal argument put forth by
appellants. Appellants indicate that the specification instructs one skilled in the art that the
DADH of the present invention can be isolated from members of the genus Candida, for
example Candida tropicalis and Candida shehatae. Page 11, lines 13-14. The appellants
also argue that the monoclonal antibodies described in the specification reasonably
enable the skilled artisan to screen for and isolate a specific DADH from any source, and
suggests that DADH from other species can be identified and isolated by determining
whether the DADH enzyme can bind to at least one of the present monoclonal antibodies.
Thus, it would appear that the experimentation required to practice the claimed method
within the claim scope would not have amounted to more than simple screening. See,
Tabuchi v. Nubel, 559 F.2d 1183, 1186, 194 USPQ 521, 523 (CCPA 1977); (Claim to a
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method of producing citric acid comprising inoculating a citric acid accumulating strain
and hydrocarbon assimilating strain of a yeast belonging to the genus Candida, was
enabled by specification generally directed to the genus Candida, with no deposited
Candida strains).
The appellants submit that the specific monoclonal antibodies of the present
invention can be used by the skilled artisan to isolate the claimed DADHs without undue
experimentation. The examiner has failed to establish, or put forth contrary fact or
argument in view of appellants rebuttal argument, why one of ordinary skill in the art would
require undue experimentation to practice the claimed invention. Moreover, it would
reasonably appear that all that is required for one of ordinary skill in the art to practice the
claimed method within the scope of the claim, is a single DADH enzyme possessing the
claimed characteristics, which is clearly enabled by the specification at page 32, Table 1.
On this basis, we hold that the examiner has not established a prima facie case of lack of
enablement.
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CONCLUSION
The rejection of the claims under 35 U.S.C. § 112, first paragraph is reversed.
REVERSED
WILLIAM F. SMITH )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
TONI R. SCHEINER )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
DEMETRA J. MILLS )
Administrative Patent Judge )
DM/dym
Appeal No. 1997-3378
Application 08/487,946
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Theodore J Leitereg
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P.O. Box 49013
San Jose, California 95161