Ex Parte Harboe

Board of Patent Appeals and Interferences

May 19, 2009

09779560 (B.P.A.I. May. 19, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MARIANNE HARBOE
__________

Appeal 2008-005837
Application 09/779,560
Technology Center 1600
__________

Decided:1 May 19, 2009
__________

Before ERIC GRIMES, LORA M. GREEN, and FRANCISCO C. PRATS,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of reducing glucoamylase activity in a medium containing recombinantly

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
Appeal 2008-005837
Application 09/779,560

produced chymosin. The Examiner has rejected the claims for lack of
adequate description in the Specification, nonenablement, and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm all of the rejections.
STATEMENT OF THE CASE
“[M]ilk clotting enzymes, also referred to as rennets or coagulants . . .
are widely used in the cheese manufacturing industry” (Spec. 2: 1-3). “The
industrially most important milk clotting enzymes of animal origin are
chymosin and pepsin” (id. at 2: 9-10).
The Specification states that “bovine chymosin is increasingly being
manufactured using recombinant DNA technology, e.g. using filamentous
fungi such as Aspergillus species” (id. at 2: 20-21). The Specification states
that “currently applied processes for manufacturing of commercial rennet
products include steps of recovering the active enzymes from crude extracts
or microbial fermentation media, followed by one or more purification
steps” (id. at 3: 1-3).
The Specification reports “the surprising discovery that undesired
enzymatic activities in polypeptide preparations can be reduced or
eliminated by a very simple process step of subjecting the preparation to low
pH for an appropriate period of time without any significant concurrent
inactivation of the active polypeptide” (id. at 3: 30-33).
Claims 5, 6, 9-14, 16-18, 35, 36, 39, 42, and 43 are pending and on
appeal. The claims subject to each rejection have not been argued separately
and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii). Claim 9 is
the only independent claim and reads as follows:
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Claim 9. A method for reducing the glucoamylase activity in a milk
clotting composition comprising the steps of:
(i) providing a medium having a pH of 2.0 or higher that comprises
chymosin activity and glucoamylase activity, wherein the medium having a
pH of 2.0 or higher is derived from the cultivation of an organism that is
selected from the group consisting of a bacterial species, a yeast species and
a species of filamentous fungi, wherein the organism comprises a gene for
encoding chymosin that is derived from a bovine or Camelidae species, and
(ii) subjecting said medium to a pH in the range of 1.0 to 1.8 for a
period of time sufficient to inactivate at least 50% of said glucoamylase
activity while maintaining at least 75% of said chymosin activity.

The claims stand rejected as follows:
• Claims 5, 6, 9-14, 16-18, 35, 36, 39, 42, and 43 under 35 U.S.C.
§ 112, first paragraph, for lack of adequate written description in the
Specification (Answer 5);
• Claims 5, 6, 9-14, 16-18, 35, 36, 39, 42, and 43 under 35 U.S.C.
§ 112, first paragraph, for lack of an enabling disclosure in the Specification
(Answer 10); and
• Claims 5, 6, 9, 12-14, 16-18, 42, and 43 under 35 U.S.C. § 103(a) as
obvious in view of Lawlis2 and Ward3 (Answer 17).
WRITTEN DESCRIPTION
Issue
The Examiner has rejected claims 5, 6, 9-14, 16-18, 35, 36, 39, 42,
and 43 under 35 U.S.C. § 112, first paragraph, on the basis that the

2 Lawlis Jr. et al., U.S. Patent 5,801,034, issued Sept. 1, 1998.
3 Ward et al., Improved Production of Chymosin in Aspergillus by
Expression as a Glucoamylase-Chymosin Fusion, 8 BIO/TECHNOLOGY 435-
440 (1990).
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Specification does not adequately describe the genus of chymosin genes
recited in the claims (Answer 5-6). The Examiner interprets the “derived
from” language of claim 9 as encompassing “a nucleic acid encoding
naturally-occurring bovine and Camelidae species chymosin as well as
mutant and variant forms thereof” (id. at 6). The Examiner finds that the
instant Specification discloses only a single example of the recited genus
(bovine chymosin), and that the prior art does not describe the genus of
Camelidae chymosin genes (id. at 7). The Examiner concludes that the
claims are not supported by an adequate description to show possession of
the claimed invention (id. at 10).
Appellant contends that “it is improper for the examiner to require
additional disclosure related to the specific organisms which might be used
with the method of the pending claims. The claims are not directed to
recombinant organisms themselves and, as such, do not require the same
level of disclosures” as required for claims to recombinant organisms per se
(Appeal Br. 6).
The issue with respect to this rejection is: Did the Examiner err in
concluding that the Specification’s description of bovine chymosin is
inadequate to show possession of the claimed method of treating chymosin-
containing compositions?
Findings of Fact
1. Claim 9 defines a method of treating a medium “derived from the
cultivation of an organism . . . , wherein the organism comprises a gene for
encoding chymosin that is derived from a bovine or Camelidae species”
(claim 9).
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2. Claim 9 requires subjecting the chymosin-containing medium to a
“pH in the range of 1.0 to 1.8 for a period of time sufficient to inactivate at
least 50% of [the] glucoamylase activity while maintaining at least 75% of
said chymosin activity” (claim 9).
3. Claim 9 therefore recites a genus of chymosin genes having two
properties: (i) they are derived from a bovine or Camelidae species, and (ii)
they encode a chymosin enzyme that retains at least 75% activity after
treatment at pH 1.0 to 1.8 has inactivated 50% of the glucoamylase activity
in the medium.
4. The Specification states that the disclosed method is applicable to
“preparations of aspartic proteases derived from a naturally produced
aspartic protease by the addition or deletion of one or more amino acids or
substituting one or more amino acids [t]herein” (Spec. 8: 32-35).
5. The Specification’s Example 1 and Example 2 describe low-pH
treatment of culture medium of “a recombinant strain of Aspergillus niger
var. awamori expressing a prochymosin-glucoamylase fusion protein”
(Spec. 9: 24-25; 10: 26-28).
6. The plasmid used in the Specification’s Example 1 and Example 2
expressed bovine chymosin (id. at 9: 14-15; 10: 17-19).
7. The Specification’s Example 3 describes treatment of “commercial
microbial and animal rennet products” (id. at 15: 6-7).
8. The only animal product included in Example 3 is “CHY-MAXTM,
a bovine chymosin produced by Aspergillus niger var. awamori” (id. at
15: 12).
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9. The Examiner finds that “the genus Camelidae . . . encompasses
alpaca, llama, vicunas, guanacos, bactrian camel and dromedarian camel”
(Answer 6).
10. Appellant’s Appeal Brief does not dispute that the genus
Camelidae encompasses alpacas, llamas, vicuñas, guanacos, bactrian camels
and dromedarian camels.
11. The Examiner finds that “the specification and prior art fail to
disclose any distinguishing identifying characteristics of a gene encoding a
Camelidae species chymosin, e.g., the nucleotide sequence of a gene
encoding a Camelidae species chymosin” (Answer 9).
12. Appellant’s Appeal Brief does not dispute the Examiner’s finding
that the prior art does not disclose the sequence of a chymosin gene from
any species in the genus Camelidae.
Principles of Law
Regardless whether a compound is claimed per se or a method
is claimed that entails the use of the compound, the inventor
cannot lay claim to that subject matter unless he can provide a
description of the compound sufficient to distinguish infringing
compounds from non-infringing compounds, or infringing
methods from non-infringing methods.
University Of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 926 (Fed.
Cir. 2004).
In claims to genetic material, . . . a generic statement such as
“vertebrate insulin cDNA” or “mammalian insulin cDNA,”
without more, is not an adequate written description of the
genus because it does not distinguish the claimed genus from
others, except by function. It does not specifically define any
of the genes that fall within its definition. It does not define
any structural features commonly possessed by members of the
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genus that distinguish them from others. One skilled in the art
therefore cannot, as one can do with a fully described genus,
visualize or recognize the identity of the members of the genus.
A definition by function . . . does not suffice to define the genus
because it is only an indication of what the gene does, rather
than what it is.
University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir.
1997).
A genus of cDNAs can be described “by means of a recitation of a
representative number of cDNAs, defined by nucleotide sequence, falling
within the scope of the genus or of a recitation of structural features common
to the members of the genus, which features constitute a substantial portion
of the genus.” Id. at 1569.
The “written description requirement can be met by ‘show[ing] that an
invention is complete by disclosure of sufficiently detailed, relevant
identifying characteristics . . . i.e., complete or partial structure, other
physical and/or chemical properties, functional characteristics when coupled
with a known or disclosed correlation between function and structure’” or a
combination thereof. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956,
964 (Fed. Cir. 2002) (emphasis omitted, alterations in original).
[W]hat is needed to support generic claims to biological subject
matter depends on a variety of factors, such as the existing
knowledge in the particular field, the extent and content of the
prior art, the maturity of the science or technology, the
predictability of the aspect at issue, and other considerations
appropriate to the subject matter.
Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).
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Analysis
The Examiner found that the genus of chymosin genes recited in
claim 9 lacks adequate description on two grounds: the disclosed species of
bovine chymosin is not representative of mutants and variants of chymosin
genes that maintain 75% activity at pH 1.0 to 1.8 (Answer 7), and bovine
chymosin does not adequately describe the genus of chymosin genes from
Camelidae species (id. at 10). We agree with the reasoning set out by the
Examiner in the Answer, and with his finding that the Specification does not
adequately describe the method of claim 9.
Appellant does not directly address the Examiner’s finding that the
Specification discloses only a single chymosin gene encompassed by the
genus recited in claim 9 or his finding that this species is not representative
of the genus. Appellant argues, instead, that the claims are directed to a
method of treating a composition produced by a recombinant organism, not
the organism itself, and the Specification adequately describes the claimed
method (Appeal Br. 6).
This argument, however, was considered and rejected in University of
Rochester. The claims in that case were directed to a method of selectively
inhibiting the enzyme PGHS-2 (also known as COX-2) by “administering a
non-steroidal compound that selectively inhibits activity of the PGHS-2 gene
product to a human.” 358 F.3d at 918. The patent did not “disclose any
compounds that can be used in its claimed methods.” Id. at 927. The court
held that a description of the compound used in the method was required to
adequately describe the method. Id. at 926.
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Similarly here, the claimed method requires using a recombinant
bacterium, yeast, or fungus that expresses a chymosin gene derived from a
bovine or Camelidae species. Just as in University of Rochester, an
adequate description of the method claimed here requires describing the
chymosin genes required to carry out the method.
The facts of this case differ from University of Rochester in that the
Specification here discloses one species within the recited genus. The court
has held, however, that a description of a single species (e.g., rat cDNA
encoding insulin) does not necessarily provide adequate description for a
genus (e.g., vertebrate or mammalian cDNA encoding insulin). See Eli
Lilly, 119 F.3d at 1567. A chemical genus may be described in various
ways, see id. at 1568, Enzo, 323 F.3d at 964, but to satisfy the first paragraph
of 35 U.S.C. § 112, the description must allow those skilled in the art to
“visualize or recognize the identity of the members of the genus.” Eli Lilly,
119 F.3d at 1568.
Appellant has pointed to no evidence of record that would support a
finding that the Specification’s description of a bovine chymosin gene is
adequate to show possession of the genus of chymosin genes recited in claim
9 and required to practice the claimed method.
Conclusion of law
The Examiner did not err in concluding that the Specification’s
description of bovine chymosin is inadequate to show possession of the
claimed method of treating chymosin-containing compositions.
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ENABLEMENT
Issue
The Examiner has rejected claims 5, 6, 9-14, 16-18, 35, 36, 39, 42,
and 43 under 35 U.S.C. § 112, first paragraph, on the basis that the
Specification is enabling for a method of treating a medium containing
bovine chymosin and Aspergillus niger glucoamylase, but not for the full
scope of the claims (Answer 10). The Examiner concludes that undue
experimentation would be required to practice the claimed method using
compositions containing chymosins from the various Camelidae species and
with mutants and variants “derived from” the naturally occurring chymosin
genes (id. at 12-15).
Appellant contends that the “claims are not directed to recombinant
organisms themselves and as such do not require the same level of
disclosure that would be required had the claims been directed to broad
claims to the organisms themselves.” (Appeal Br. 8-9.) Appellant contends
that the claims are directed to a method of treating chymosin-containing
compositions, the steps of the recited method are adequately enabled, and “it
is improper for the examiner to require additional disclosure related to the
specific organisms which might be used with the method of the pending
claims” (id. at 8).
The issue with respect to this rejection is: Did the Examiner err in
considering the scope of chymosin genes recited in the claims as a factor in
the enablement analysis?
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Principles of Law
“[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without ‘undue experimentation.’” In re Wright, 999 F.2d 1557, 1561 (Fed.
Cir. 1993).
Factors to be considered in determining whether a
disclosure would require undue experimentation . . . 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.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Analysis
The Examiner has interpreted claim 9 as encompassing a method of
treating media comprising mutants and variants of naturally occurring
chymosin genes that maintain 75% activity at pH 1.0 to 1.8 and chymosin
genes from various Camelidae species (Answer 12). We agree with the
Examiner’s interpretation of the claims, and Appellant does not take issue
with it.
Appellant argues, instead, that the claims are directed to a method of
treating a composition, not to the materials that are used to make the starting
composition. Appellant contends that “there is no need to actually make
every possible starting material in order to practice the invention as the
specification teaches that the simple steps of the invention may be applied to
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chymosin compositions having undesired enzymatic activity” (Appeal Br. 7-
8).
Appellant has pointed to no case law supporting her position that the
experimentation required to make the starting materials of a claimed method
should not be considered in determining whether the method is enabled. The
court’s analysis in Wands, in fact, supports the opposite conclusion.
The claims at issue in Wands were directed to an immunoassay
method for detecting hepatitis B surface antigen (HbsAg). Wands, 858 F.2d
at 734. The claimed method required using “a monoclonal high affinity IgM
antibody having a binding affinity constant for said HbsAg determinants of
at least 109 M-1.” Id. The rejection on appeal was “directed solely to
whether the specification enables one skilled in the art to make the
monoclonal antibodies that are needed to practice the invention.” Id. at 735.
The applicants in Wands had deposited a single hybridoma expressing
antibodies meeting the claim limitations, id. at 734, and the applicants’
“disclosure provide[d] considerable direction and guidance on how to
practice their invention and present[ed] working examples. There was a
high level of skill in the art at the time when the application was filed, and
all of the methods needed to practice the invention were well known.” Id. at
740. The court held that “Wands’ evidence thus effectively rebut[ted] the
examiner’s challenge to the enablement of their disclosure.” Id.
This case is similar to Wands in that the rejection is based on the
Examiner’s conclusion that undue experimentation would be required to
make the starting materials used in claimed process. Wands, therefore
supports the basis of the Examiner’s rejection.
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This case differs from Wands, however, in that Appellant has pointed
to no evidence in the record to show that obtaining the other chymosin genes
encompassed by the claims – chymosin genes from animals of the genus
Camelidae and mutants or variants of bovine and Camelidae chymosin
genes – would have required no more than routine experimentation at the
time this application was filed.
The Examiner has provided a reasoned analysis, based on the
evidence of record and the factors set out in In re Wands, for concluding that
practicing the full scope of the claimed method would have required undue
experimentation at the time of filing. Appellant has not pointed to evidence
of record that rebuts the Examiner’s challenge to the enablement of the
instant disclosure.
Conclusion of law
The Examiner did not err in considering the scope of chymosin genes
recited in the claims as a factor in the enablement analysis.
OBVIOUSNESS
Issue
The Examiner has rejected claims 5, 6, 9, 12-14, 16-18, 42, and 43
under 35 U.S.C. § 103(a) based on Lawlis and Ward (Answer 17). The
Examiner finds that Lawlis teaches a method of killing cells in culture
medium using, for example, formic acid and a pH of 1.75 or less (id. at 18),
and that Ward teaches Aspergillus niger var. awamori cells expressing a
glucoamylase/chymosin fusion protein (id. at 19). The Examiner concludes
that it would have been obvious “to use a culture of the transformant of
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Ward in a method of Lawlis, namely, treating the culture with sulfuric acid
to a pH of 1.75 and then adding formic acid to effect substantial cell kill”
(id. at 19-20).
Appellant contends that the references do not disclose inactivating at
least 50% of glucoamylase activity while maintaining chymosin activity, and
that this property is not inherent in Lawlis’ method because Lawlis’
preferred embodiment of acetic acid would not require using a pH of 1.0 to
1.8 (Appeal Br. 10-11). Appellant also contends that inactivating
glucoamylase activity without destroying the chymosin activity is an
unexpected result of low pH treatment (id. at 13).
The issue with respect to this rejection is: Does the evidence of
record, considered as a whole, support the Examiner’s conclusion that it
would have been obvious to those of ordinary skill in the art to subject
Ward’s chymosin-containing medium to a pH of 1.75, as taught by Lawlis?
Additional Findings of Fact
13. Ward discloses an expression vector encoding bovine
prochymosin B fused in frame with the glucoamylase (glaA) gene of
Aspergillus niger var. awamori, or A. awamori (Ward 435).
14. Ward discloses that “this plasmid led to the secretion of
considerably higher amounts of chymosin than obtained with previous
chymosin expression vectors” (id. at 435, right col.).
15. Ward discloses that the evidence “suggests that mature chymosin
is autocatalytically released from the glucoamylase-chymosin fusion protein
after secretion” (id.).
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16. Ward discloses that “an increase in active chymosin concentration
could be induced simply by lowering the pH of samples to 2” (id. at 439,
right col.).
17. Lawlis discloses that it is necessary to kill microorganisms
expressing recombinant DNA at the end of a fermentation process in order
to prevent release of recombinant organisms into the environment (Lawlis,
col. 1, ll. 18-25).
18. Lawlis discloses that
it is desirable to simply kill the microorganisms without lysing
the cells . . . in systems where the cells manufacture and secrete
the desired product extracellularly because lysing the cells
releases additional cell debris and materials into the medium,
thus making recovery and purification of the desired secreted
product more difficult and costly.
(Id. at col. 1, ll. 46-52.)
19. Lawlis discloses that “in a culture of Aspergillus niger for the
production of chymosin, reducing the pH to about 2 using sulfuric acid does
not accomplish a complete or substantially complete cell kill” (id. at col. 2,
ll. 61-64).
20. Lawlis discloses a method of killing yeast, bacteria, or fungi in a
culture by
selecting a compatible organic acid having 1 to 5 carbon atoms
or a compatible salt thereof, and then in either order;
(i) adjusting the pH of the culture to a value equal to or less
than about 2 pH units below the pKa of the selected
compatible organic acid and/or salt thereof; and
(ii) adding a sufficient amount of the selected compatible
organic acid and/or salt
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to effect a substantially complete kill of the microorganism in
the culture.
(Id. at col. 2, ll. 28-39.)
21. Lawlis discloses that the “‘organic acid’ employed . . . can be any
suitable and compatible acid having 1 to about 5 carbon atoms” (id. at col. 3,
ll. 29-31).
22. Lawlis discloses that a “preferred acid is acetic acid because it is
effective with a wide range of cells and because it is one of the lowest cost
acids available. Other effective acids can be used depending on the cell
cultures involved and the economics of the process.” (Id. at col. 4, ll. 49-
53.)
23. Lawlis discloses that, “[f]or example, if formic acid (pKa=3.75) is
to be used to accomplish the cell kill, the pH of the mixture will be adjusted
with a mineral acid to about 1.75 or less, then formic acid is added to
accomplish the cell kill” (id. at col. 3, ll. 56-60).
24. Lawlis provides a working example describing “a substantially
complete cell kill of A. niger var. awamori” by adjusting the pH to 2.0 with
sulfuric acid and addition of 4% glacial acetic acid, followed by storage
overnight (id. at col. 6, ll. 4-29).
25. The instant Specification discloses that the
low pH treatment according to the invention is made for a
period of time that is required to inactivate the side
activity/activities to a desired level and that does not inactivate
the biological activity of the desired polypeptide unacceptably.
Typically, however, the required treatment period is within the
range of 0.1 minutes to 48 hours such as a range of 1 minute to
36 hours including the range of 10 minutes to 24 hours.
(Spec. 7: 19-22.)
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Principles of Law
An invention
composed of several elements is not proved obvious merely by
demonstrating that each of its elements was, independently,
known in the prior art. . . . [I]t can be important to identify a
reason that would have prompted a person of ordinary skill in
the relevant field to combine the elements in the way the
claimed new invention does.
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed
purpose of the patentee controls. . . . [A]ny need or problem
known in the field of endeavor at the time of invention and
addressed by the patent can provide a reason for combining the
elements in the manner claimed.
Id. at 419-20.
In some cases, [an] inherent property corresponds to a claimed
new benefit or characteristic of an invention otherwise in the
prior art. In those cases, the new realization alone does not
render the old invention patentable. . . . Thus, when
considering a prior art method, the anticipation doctrine
examines the natural and inherent results in that method without
regard to the full recognition of those benefits or characteristics
within the art field at the time of the prior art disclosure.
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377-1378 (Fed. Cir.
2005).
“[I]t is well settled that unexpected results must be established by
factual evidence. ‘Mere argument or conclusory statements in the
specification does not suffice.’” In re Geisler, 116 F.3d 1465, 1470 (Fed.
Cir. 1997), quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).
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Analysis
Ward discloses recombinant A. niger var. awamori cells that secrete a
glucoamylase/bovine chymosin fusion protein into the culture medium.
Ward teaches that active chymosin is released from the fusion protein,
probably through autocatalytic cleavage, and that lowering the pH to 2
increases the amount of active chymosin.
Lawlis teaches that killing recombinant cultured cells without lysing
the cells is useful where the cells secrete the desired protein into the culture
medium. Lawlis teaches a method for killing cells without lysing them by
lowering the pH of the medium to at least 2 pH units below the pKa of an
organic acid having 1-5 carbon atoms. Lawlis expressly suggests using
formic acid and lowering the pH of the medium to 1.75 or lower.
It would have been obvious to a person of ordinary skill in the art to
use Lawlis’ method of cell-killing to kill the chymosin-expressing cells
taught by Ward because Ward’s cells secrete the desired chymosin into the
culture medium, and Lawlis discloses that its method of killing cells without
lysing them is especially useful for such cells. A person of ordinary skill in
the art also would have considered it obvious to use a combination of formic
acid and a pH of 1.75 or lower in Lawlis’ method because Lawlis expressly
suggests that combination.
A skilled worker would have reasonably expected that Lawlis’
method would not adversely affect the activity of the chymosin produced by
Ward’s cells because Ward teaches that a pH of 2 actually increased the
amount of active chymosin, and pH 1.75 is reasonably close to pH 2.
Neither Lawlis nor Ward discuss the effect of low pH on glucoamylase, but
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Lawlis exemplifies acid treatment carried out overnight, and the instant
Specification states that acid treatment for as little as 0.1 minutes is enough
to inactivate side activities such as glucoamylase. Therefore, it is reasonable
to conclude that combining Lawlis’ method with Ward’s cells would
inherently result in inactivating at least 50% of glucoamylase activity.
Appellant argues that the references do not suggest inactivating
glucoamylase activity by reducing pH, or that “this can be accomplished
without destroying the chymosin activity” (Appeal Br. 13). Appellant
argues that the Examiner’s conclusion that the method suggested by the prior
art would have inherently caused these effects is improper because “there is
no showing that the unexpected results would have been recognized or
appreciated by a person having ordinary skill in the art” (id.).
This argument is not persuasive. The references do not suggest
treating bovine chymosin-containing culture medium to low pH in order to
inactivate glucoamylase, but the prior art need not suggest combining
teachings for the same reason the applicant combined them in order to make
a claimed invention obvious. Here, a skilled artisan would have combined
Lawlis’ low pH treatment with Ward’s culture in order to kill the cells in
Ward’s culture without lysing them. The effect of inactivating 50% of the
glucoamylase activity, as recited in the instant claims, is simply an inherent
result of practicing the method made obvious by the prior art.
In addition, Appellant has pointed to no evidence of record to support
her argument that the effect of low pH on glucoamylase activity would not
have been expected by those of skill in the art. An assertion of unexpected
results must be supported by evidence, not just attorney argument or
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conclusory statements. Since no evidence has been cited, Appellant’s
argument based on unexpected results is not persuasive.
Conclusion of law
The evidence of record, considered as a whole, supports the
Examiner’s conclusion that it would have been obvious to those of ordinary
skill in the art to subject Ward’s chymosin-containing medium to a pH of
1.75, as taught by Lawlis.
SUMMARY
We affirm the rejection of claims 5, 6, 9-14, 16-18, 35, 36, 39, 42, and
43 under 35 U.S.C. § 112, first paragraph, for both lack of enablement and
lack of adequate written description in the Specification. We affirm the
rejection of claims 5, 6, 9, 12-14, 16-18, 42, and 43 under 35 U.S.C.
§ 103(a) as obvious in view of Lawlis and Ward.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

cdc
Stanislaus Aksman
Hunton & Williams
Suite 1200
1900 K Street, N.W.
Washington DC 20006
20