Ex parte Meyhack et al.

Board of Patent Appeals and Interferences

Sep 9, 1998

07488513 (B.P.A.I. Sep. 9, 1998)

Application for patent filed February 27, 1990. According to applicants, this1
application is a continuation of Application 06/938,102, filed December 4, 1986, now
abandoned.
1
Paper No. 38
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(2) is not binding precedent of the Board.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 BERND MEYHACK,
WALTER MARDI and JUTTA HEIM
______________
Appeal No. 94-1775
Application 07/488,5131
_______________
ON BRIEF
_______________
Before WINTERS and WILLIAM F. SMITH, Administrative Patent Judges, and
MCKELVEY, Senior Administrative Patent Judge.
WILLIAM F. SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of claims 1, 5
through 16 and 18, all the claims remaining in the application.
Appeal No. 94-1775
Application 07/488,513
2
Claims 1, 18, 15 and 16 are illustrative of the subject matter on appeal and read as
follows:
1. Method for the production of proteins with hirudin activity comprising culturing
under appropriate nutrient conditions yeast cells transformed with a hybrid vector
comprising
one to four DNA inserts each comprising a yeast promoter selected from the group
consisting of the PHO5 promoter, the GAPDH promoter and a hybrid promoter comprising
upstream activation sequences of the PHO5 gene and downstream promoter elements
including a functional TATA box of the GAPDH gene,
a DNA segment consisting of a first DNA sequence encoding the PHO5 or
invertase signal peptide upstream of and in reading frame with a second DNA sequence
coding for mature desulphato-hirudin which DNA segment is under transcriptional control
of said yeast promoter, and a DNA sequence containing eukaryotic transcription
termination signals,
and a selective gene marker selected from the group consisting of URA1, URA3,
ARG4, LEU2, HIS3, HIS4, TRP5 and TRP1, wherein the proteins with hirudin activity are
predominantly secreted into the culture medium, and
isolating the proteins with hirudin activity from the culture medium.
18. A method according to claim 1 wherein about 90% or more of the proteins with
hirudin activity are secreted into the culture medium.
15. A yeast hybrid vector comprising one to four DNA inserts each comprising a
yeast promoter selected from the group consisting of the PHO5 promoter, the GAPDH
promoter and a hybrid promoter comprising upstream activation sequences of the PHO5
gene and downstream promoter elements including a functional TATA box of the GAPDH
gene, a DNA segment consisting of a first DNA sequence encoding the PHO5 or invertase
signal peptide upstream of and in reading frame with a second DNA sequence coding for
mature desulphatohirudin which DNA segment is under transcriptional control of said yeast
promoter, and a DNA sequence containing eukaryotic transcription termination signals,
and a selective gene marker selected from the group consisting of URA1, URA3, ARG4,
LEU2, HIS3, HIS4, TRP5 and TRP1.
Appeal No. 94-1775
Application 07/488,513
Our consideration of the patent documents identified as Tolstoshev and Tripier2
has been based upon English language translations of the full text documents. Copies of
the translations are enclosed with this opinion.
3
16. A yeast cell transformed with a hybrid vector comprising one to four DNA
inserts each comprising a yeast promoter selected from the group consisting of the PHO5
promoter, the GAPDH promoter and a hybrid promoter comprising upstream activation
sequences of the PHO5 gene and downstream promoter elements including a functional
TATA box of the GAPDH gene, a DNA segment consisting of a first DNA sequence
encoding the PHO5 or invertase signal peptide upstream of and in reading frame with a
second DNA sequence coding for mature desulphatohirudin which DNA segment is under
transcriptional control of said yeast promoter, and a DNA sequence containing eukaryotic
transcription termination signals, and a selective gene marker selected from the group
consisting of URA1, URA3, ARG4, LEU2, HIS3, HIS4, TRP5 and TRP1, and mutants
thereof.
The references relied upon by the examiner are :2
Derynck et al. (Derynck) 4,742,003 May 3, 1988
Brake et al. ((Brake) 4,752,576 June 21, 1988
Chang et al. (Chang) 5,010,003 Apr. 23, 1991
Eur. Pat. App.(Kramer) 0 124 874 Nov. 14, 1984
Eur. Pat. App. (Tolstoshev) 0 158 564 Oct. 16, 1985
Eur. Pat. App. (Tripier) 0 158 986 Oct. 23, 1985
Edens et al. (Edens), “Synthesis and Processing of the Plant Protein Thaumatin in Yeast”,
Cell, Vol. 37, pages 629-633 (June 1984).
We make the following patent of record:
Liersch et al. (Liersch) 5,422,249 June 6, 1995
Claims 1, 5 through 16 and 18 stand rejected under 35 U.S.C. § 103 as
unpatentable over Chang in view of any of Brake, Edens, Kramer or Derynck and either of
Appeal No. 94-1775
Application 07/488,513
4
Tolstoshev or Tripier. In addition, claims 1, 5 through 14 and 18 are provisionally rejected
under the judicially created doctrine of obviousness- type double patenting as unpatentable
over claim 16 of copending application 07/700,997 in view of Chang and further in view of
Brake, Edens, Kramer and Derynck. Finally, claims 1, 5 through 14 and 18 are
provisionally rejected under 35 U.S.C. § 103 as obvious over copending application
07/700,997 in view of Chang and further in view of Brake, Edens, Kramer and Derynck.
We vacate the two provisional rejections based upon application 07/700,997. We
also vacate the obviousness rejection premised in part upon Chang as it pertains to claims
1 and 5 through 16 and reverse this rejection as it pertains to claim 18. We also make a
new ground of rejection under the provisions of 37 CFR § 1.196(b).
PROVISIONAL REJECTIONS
Each of these rejections is premised upon application 07/700,997 which now
stands abandoned. However, that application was refiled as application 08/121,974 which
issued as U.S. Patent 5,422,249. Since the underlying premise of the two provisional
rejections, application 07/700,997 is now abandoned, any issues regarding the
patentability of the claims pending in this application on the basis of the claims then
pending in that abandoned application are moot. Accordingly, we vacate the two
provisional rejections. Upon return of the application, the examiner should consider the
`249 patent and determine whether the now issued patent adversely affects the
Appeal No. 94-1775
Application 07/488,513
5
patentability of any claim pending in this application. If so, the examiner should issue an
appropriate Office action setting forth all appropriate rejections.
REJECTION UNDER 35 U.S.C. § 103 PREMISED UPON CHANG
1. Claim 18
Claim 18 is directed to a method for producing proteins with hirudin activity which
comprises culturing under appropriate nutrient conditions yeast cells which have been
transformed with a specified hybrid vector. In relevant part, claim 18 requires that 90% or
more of the proteins with hirudin activity are secreted into the culture medium.
Assuming without deciding that the references relied upon by the examiner would
have suggested the construction and use of yeast cells transformed with the hybrid vector
required by claim 1 on appeal, the rejection before us still cannot be sustained. According
to pages 3-6 of the Examiner’s Answer, the examiner’s position in regard to the required
level of secretion of proteins with hirudin activity is:
[a]ny differences between the amount of protein product secreted using the
method of the instant invention, and that of Chang et al. is considered to be
expected, since such variability was well known at the time of the invention,
as has been pointed out by the applicant in previous arguments and in the
Declaration of Dr. Hinnen, submitted 8/9/90, Paper No. 16, and appended to
the Brief.

While the record of this application may support the proposition that transformed
yeasts will secret heterologous proteins in a variable amount, that does not in and of itself
support the finding which needs to be made under these circumstances, i.e., whether the
Appeal No. 94-1775
Application 07/488,513
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prior art relied upon by the examiner would have reasonably suggested that the specific
yeast containing the hybrid vector required by claim 18 on appeal secrete 90% or more of
the proteins with hirudin activity into the culture medium. At the point where we need a
specific, fact supported determination by the examiner, we are only left with a vague
conclusion on the part of the examiner.
Obvious determinations must be premised upon a consideration of the “subject
matter as a whole.” 35 U.S.C. § 103. Here, the examiner has failed to adequately come to
grips with the requirement of claim 18 on appeal that 90% or more of the proteins with
hirudin activity produced in that method are secreted into the culture medium. As a
consequence, the examiner has failed to properly discharge his initial burden of
establishing that the subject matter of claim 18, as a whole, would have been prima facie
obvious to one of ordinary skill in the art.
The rejection of claim 18 under 35 U.S.C. § 103 premised upon Chang is reversed.
2. Claims 1 and 5 through 14
Claim 1 differs from claim 18 in that claim 1 requires that “proteins with hirudin
activity are predominantly secreted into the culture medium” rather than at a level of 90% or
more. Thus, prior to determining whether the subject matter of claim 1 as a whole would
have been obvious to one of ordinary skill in the art based upon the applied references, a
determination must be made as to what is meant by the requirement of claim 1 that the
proteins with hirudin activity are predominantly secreted into the culture medium.
Appeal No. 94-1775
Application 07/488,513
7
This claim requirement was added by amendment on May 16, 1991 (Paper No.
18). When this amendment was presented, appellants did not specify where in the original
disclosure of this application, the amendatory language found written descriptive support
or attempt to describe the metes and bounds of the word “predominantly.” In similar
fashion, the examiner has not favored the record with his view as to where the original
disclosure of the application provides written descriptive support for the newly added
language or discussed the metes and bounds of the word “predominantly.”
Assuming again without deciding that the prior art relied upon by the examiner
would have suggested the use of yeast cells transformed with the hybrid vector required by
claim 1 on appeal to produce proteins with hirudin activity, one is not in a position to make
a patentability determination of the subject matter of claim 1 under
35 U.S.C.§ 103 as a whole until an understanding is reached as to whether the original
disclosure of this application provides written descriptive support of the amendatory
language under 35 U.S.C. § 112, first paragraph, and, if so, what the metes and bounds of
this amendatory language are. Thus, we are not in a position to render a final decision as
to whether the subject matter of claim 1 as a whole would have been obvious to one of
ordinary skill in the art. Claims 5 through 14 depend from claim 1 and do not clarify this
matter. Accordingly, we vacate the rejection under 35 U.S.C. § 103 premised upon Chang
as it pertains to claims 1 and 5 through 14. But see the new grounds of rejections below
under the provisions of 37 CFR § 1.196(b).
Appeal No. 94-1775
Application 07/488,513
8
3. Claims 15 and 16
We vacate the prior art rejection as it pertains to these claims since we have no
analysis from the examiner in support of his conclusion that these two claims are
unpatentable. Claim 15 is directed to a yeast hybrid vector having specified DNA
sequences and claim 16 is directed to a yeast cell transformed with a hybrid vector
containing specified DNA sequences. These claims have not been separately discussed
by the examiner and appellants in this appeal. While these claims do not explicitly require
that the yeast hybrid vector or the yeast cell transformed with the hybrid vector must
function upon use to secrete proteins with hirudin activity into the culture medium in any
particular amount, their patentability must be determined with that property in mind. As set
forth in In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963), “a compound
and all of its properties are inseparable; they are one and the same thing.”
In our view, the same concept applies to composition of matter claims 15 and 16.
Until appellants and the examiner have separately addressed the merits of the patentability
of these claims, taking into account the properties possessed by the yeast
hybrid vector and transformed yeast cell, we are not in a position to render a final decision
on the patentability of these claims. It may be that yeast hybrid vectors according to claim
15 on appeal and transformed yeast cells according to claim 16 on appeal possess the
property of expressing proteins with hirudin activity over a wide range of values. Some
values within that range may reasonably be concluded to have been expected based upon
Appeal No. 94-1775
Application 07/488,513
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a consideration of the prior art. Other values within that range may be considered to have
been unexpected based upon a consideration of the same prior art. If the examiner and
appellants determine that to be the situation, cases such as In re Muchmore, 433 F.2d
824, 826, 167 USPQ 681, 683 (CCPA 1970) in which the court held that claims which
read on both obvious and unobvious subject matter are obvious under 35 U.S.C. § 103
need to be considered. This analysis needs to be made by the examiner and appellants in
the first instance and should not be made by this board in a vacuum. By statue, this board
acts as a board of review.
35 U.S.C. § 7 (“The [board] shall . . . review adverse decisions of examiners upon
applications for patents . . .”).
Upon return of the application, the examiner should consider the patentability of
claims 15 and 16 apart from the method claims pending in this application. If the examiner
determines that claims 15 and 16 are unpatentable, he should issue an appropriate Office
action so that appellants will have a full and fair opportunity to respond to the newly stated
position.
NEW GROUNDS OF REJECTION UNDER 37 CFR § 1.196(B)
Under the provisions of 37 CFR § 1.196(b), we make the following new grounds of
rejection.
Appeal No. 94-1775
Application 07/488,513
Issues such as those raised in this new ground of rejection would be avoided in3
the most part if examiners would enforce the requirements of 37 CFR § 1.75(d)(1) when
amendments are submitted during the prosecution of an application. If upon receipt of the
amendment filed May 16, 1991, in this application, the examiner had required appellants
to state for the record where the amended claim language finds “clear support or
10
Claims 1 and 5 through 14 are rejected under 35 U.S.C. § 112, first paragraph, as
lacking written descriptive support in the original disclosure of this application and 35
U.S.C. § 112, second paragraph, as being indefinite.
As set forth above, claim 1 was amended during prosecution of this application to
require that the proteins with hirudin activity are “predominantly” secreted into the culture
medium. The specification of this application consists of 117 pages. Appellants did not
point out where the original disclosure of this application provided the written descriptive
support required under 35 U.S.C. § 112, first paragraph. Our review of the matter,
hampered as it was by the lack of guidance from appellants, did not reveal any portion of
the specification which can reasonably be said to provide the requisite written descriptive
support for the amendatory language.
An integral part of the analysis to determine whether the original disclosure of this
application provides written descriptive support for the questioned amendatory language
is a determination of the metes and bounds of the word “predominantly.” If one does not
know what to look for, one will never know whether they found it. As the record now stands,
the written descriptive support for and the metes and bounds of the questioned term
cannot be readily ascertained. 3
Appeal No. 94-1775
Application 07/488,513
antecedent basis in the description,” these issues would have been resolved at an earlier
point in time.
11
TIME PERIOD FOR RESPONSE
This opinion contains a new ground of rejection pursuant to 37 CFR § 1.196(b)
(amended effective Dec. 1, 1997, by final rule notice, 62 Fed. Reg. 53,131, 53,197 (Oct.
10, 1997), 1203 Off. Gaz. Pat. & Trademark Office 63, 122 (Oct. 21, 1997)).
37 CFR § 1.196(b) provides that, “A new ground of rejection shall not be considered final
for purposes of judicial review.”
37 CFR § 1.196(b) also provides that the appellant, WITHIN TWO MONTHS FROM
THE DATE OF THE DECISION, must exercise one of the following two options with
respect to the new ground of rejection to avoid termination of proceedings (§ 1.197(c)) as
to the rejected claims:
(1) Submit an appropriate amendment of the claims so rejected or a
showing of facts relating to the claims so rejected, or both, and have the
matter reconsidered by the examiner, in which event the application will be
remanded to the examiner. . . .
(2) Request that the application be reheard under § 1.197(b) by the
Board of Patent Appeals and Interferences upon the same record. . . .
No time period for taking any subsequent action in connection with this appeal may
be extended under 37 CFR § 1.136(a).
REVERSED-IN-PART
VACATED-IN-PART
37 CFR § 1.196(b)
Appeal No. 94-1775
Application 07/488,513
12
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
WILLIAM F. SMITH ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
FRED E. MCKELVEY, Senior )
Administrative Patent Judge )

Appeal No. 94-1775
Application 07/488,513
13
Michael W. Glynn
CIBA-GEIGY Corp.
Patent Department
520 White Plains Road
P. O. Box 2005
Tarrytown, N Y 10591-9005