Ex parte Horwich et al.

Board of Patent Appeals and Interferences

Aug 30, 1999

07673158 (B.P.A.I. Aug. 30, 1999)

Application for patent filed March 18, 1991. According to appellants, this application is 1
a continuation of Application 07/261,573, filed October 24, 1988 (abandoned).
1
Paper No. 34
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publication in a law journal and (2) is not binding precedent of the Board.
UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_______________
Ex parte ARTHUR L. HORWICH,
MINGYUAN CHENG,
RICHARD MALLBERG,
DONALD S. READING
and ALAN MYERS
______________
Appeal No. 1995-2374
Application 07/673,1581
_______________
ON BRIEF
_______________
Before WINTERS, WILLIAM F. SMITH, and LORIN, Administrative Patent Judges.
WILLIAM F. SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 of the examiner's decision refusing to
allow claims 5 through 9 and 11 through 18, all the claims pending in the application.
Appeal No. 1995-2374
Application 07/673,158
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Claims 5, 11, and 16 are illustrative of the subject matter on appeal as read as
follows:
5. A DNA segment consisting essentially of an isolated, non-chromosomal DNA
segment encoding Hsp60, a mitochondrial eucaryotic protein having a molecular weight
between 55,000 and 65,000 by SDS-polyacrylamide gel electrophoresis under denaturing
conditions, wherein the Hsp60
(a) has at least 80% homology at the amino acid and nucleic acid level with the
sequences shown in Figure 1, and
(b) interacts with newly synthesized proteins to fold them into their biologically active
conformation.
11. A vector capable of autonomous replication in a cell, said vector containing an
operatively linked polynucleotide sequence segment that encodes Hsp60.
16. A transformed host cell containing a vector that autonomously replicates
therein, said vector containing an operatively linked polynucleotide sequence segment that
encodes Hsp60.
The examiner has not relied upon prior art in rejecting the claims on appeal.
Rather, claims 5 through 9 stand rejected under 35 U.S.C. § 112, second paragraph, as
being indefinite. Claims 5, 9 and 11 through 18 also stand rejected under 35 U.S.C.
§ 112, first paragraph (enablement). We reverse. In addition, we raise an issue for the
examiner and appellants to consider upon return of the application.
DISCUSSION
1. Definiteness
As set forth on pages 2-3 of the Examiner's Answer, the examiner considers claims
5 to 9 to be indefinite through their use of the word “homology” since “this term is
Appeal No. 1995-2374
Application 07/673,158
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recognized to evolutionary origins by practitioners of this art and it would seem that that
definition is not what is intended here.”
Manifestly, the examiner has not used the correct legal standard in determining
whether claims 5 through 9 comply with the definiteness requirement of 35 U.S.C.
§ 112, second paragraph. As set forth in In re Moore, 439 F.2d 1232, 1235, 169 USPQ
236, 238 (CCPA 1971), this section of the statute only requires that the claims “set out and
circumscribe a particular area with a reasonable degree of precision and particularity.”
The court stated that claim language must be analyzed “not in a vacuum, but always in light
of the teachings of the prior art and of the particular application disclosure as it would be
interpreted by one possessing the ordinary skill in the pertinent art.” Here, all we have is
the examiner's unsupported conclusion that the word “homology” has been somehow
misused by appellants. The examiner has not provided any analysis based upon prior art
usage of this word or how the supporting specification of the application uses this word in
support of this position. Absent a fact based explanation from the examiner premised
upon the correct legal standard, the rejection can not be sustained.
The examiner has also rejected claims 5 through 9 under this section of the statute
on pages 7-8 of the Examiner's Answer. The examiner questions whether the reference to
“the sequence shown in Figure 1" in claims 5 and 6 refers to the amino acid sequence or
the nucleotide sequence depicted in this figure. As explained by appellants, it is quite
Appeal No. 1995-2374
Application 07/673,158
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clear that claim 5 refers to the amino acid sequence of Figure 1 while claim 6 refers to the
nucleotide sequence of Figure 1.
Both rejections under 35 U.S.C. § 112, second paragraph, are reversed.
2. Enablement
As explained on pages 3-4 of the Examiner's Answer, the examiner believes that
the claims on appeal must be limited to the “nucleic acid sequence of Figure 1.” We
disagree.
Again, in making this rejection, the examiner has not used the correct legal
standard. The issue raised by the examiner is whether one skilled in the art could make
and use the claimed invention throughout its scope without undue experimentation. As set
forth in the sentence bridging pages 3-4 of the Examiner's Answer:
“It would require undue experimentation for one of skill in the art to have to
make every protein which has 'at least 80% homology' with the protein
whose sequence is given in Figure 1 and then to test every single one of
these homologues to determine whether it will function to 'fold [newly
synthesized proteins] into their biologically active conformation.”
As explained in PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564,
37 USPQ2d 1618, 1623 (Fed. Cir. 1996):
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.
denied, 502 U.S. 856 (1991); In re Vaeck, 947 F.2d at 496, 20 USPQ2d at
Appeal No. 1995-2374
Application 07/673,158
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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 Appeal 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).
Here, all the examiner has established is that some experimentation would be
required to make and use other embodiments of the claimed invention. What the examiner
has not done is perform the fact finding needed in order to reach a proper conclusion of
undue experimentation. The examiner has not relied upon any evidence in support of this
rejection which would establish that making and testing other sequences beyond those
described in the present specification amounts to undue experimentation. The examiner's
unsupported conclusion does not suffice.
The rejection under 35 U.S.C. § 112, first paragraph, is reversed.
OTHER ISSUES
The following statement appears at page 4 of the Examiner's Answer:
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Application 07/673,158
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It is also noted that the only DNA segments, vectors, and hosts for
which the specification provides adequate written description are those
limited to the DNA sequence of Figure 1.
While raising an issue under the written description requirement of 35 U.S.C. § 112, first
paragraph, the examiner has not made a separate rejection under this section of the
statute. Rather, the only rejection made is under the enablement requirement, not the
written description requirement.
Subsequent to the briefing in this appeal, our appellate reviewing court issued the
decision in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398
(Fed. Cir. 1997). Therein, the court determined that claims to genetic material which are
couched only in functional language describing what the DNA does do not distinguish the
claimed genus from others and are not described in accordance with 35 U.S.C. § 112, first
paragraph, by equally broad language in the application.
Upon return of the application, the examiner should review all of the claims pending
in this application and determine whether they comply with the written description
requirement 35 U.S.C. § 112, first paragraph. In so doing, the examiner should take into
account the decision in University of California, supra. Also, the examiner should note that
claims, such as claims 11 and 16, define genetic material in a manner which is broader
than the definition of the genetic material in claim 5. It does not appear that the examiner
has separately considered the patentability of claims 11 and 16 on this record.
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Application 07/673,158
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The decision of the examiner is reversed.
REVERSED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
WILLIAM F. SMITH ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
HUBERT C. LORIN )
Administrative Patent Judge )
Appeal No. 1995-2374
Application 07/673,158
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