Ex Parte Groner

Patent Trial and Appeal Board

Jan 29, 2014

11592336 (P.T.A.B. Jan. 29, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ALBRECHT GRÖNER
____________

Appeal 2012-009188
Application1 11/592,336
Technology Center 1600
____________

Before DONALD E. ADAMS, ERICA A. FRANKLIN, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
process of making an influenza virus vaccine. The Examiner has rejected
the claims as for being indefinite, obviousness, and under non-statutory
obvious type double patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 Appellant identifies Novartis Vaccines and Diagnostics GmbH & Co. as
the Real Party in Interest (App. Br. 2).
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STATEMENT OF THE CASE
The Specification provides “for the replication of influenza viruses in
cell culture at reduced temperatures.” (Spec. 1.) The “kidney cell line
MDCK, which . . . is adapted to growth in suspension in serum-free
medium . . . [provides for] simple and efficient culturing and virus
replication.” (Spec. 5.) “The addition of a protease which brings about the
cleavage of the precursor protein of hemagglutinin [HAo] and thus the
adsorption of the viruses to the cells, can be carried out according to the
invention shortly before, simultaneously with or shortly after the infection of
the cells with influenza viruses.” (Spec. 7.)
Claims 1, 4-7, 15, 16, and 20-29 are on appeal, and can be found in
the Claims Appendix of the Appeal Brief. Claim 1 is representative of the
claims on appeal, and reads as follows:
Claim 1: A process for making a vaccine for administration to
humans or animals, the process comprising:
culturing MDCK cells that can be infected by influenza
viruses in a serum-free medium;
adding a protease to the serum-free medium containing
the cultured cells;
infecting the cultured cells in the serum-free medium
comprising the protease with influenza viruses, wherein
infecting is performed by adding the influenza viruses to the
medium of the cultured cells, and wherein the protease is added
to the cultured cells before or during infection with influenza
viruses;
culturing the infected cells at a temperature of 33° C for
virus replication, wherein the virus replicates;
harvesting and isolating the replicated influenza viruses;
and
formulating the replicated influenza viruses to provide
the vaccine.
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The Examiner has rejected the claims2 as follows:
I. Claims 1, 4-7, and 21 under 35 U.S.C. § 103(a) over Smith3 in
view of Kistner.4
II. Claims 16 and 22-29 under 35 U.S.C. § 103(a) over Smith in
view of Kistner, and in further view of Nerome.5
III. Claims 1, 4-7, and 16 under nonstatutory obviousness-type
double patenting over claims 2, 10, 11, 14-20, 23, 31, 32, and 35-41 of U.S.
Patent No. 6,656,720.
IV. Claims 1, 4-7, and 15 under nonstatutory obviousness-type
double patenting over claims 3, 11, 12, and 15-10 of U.S. Patent
No. 6,455,298.
V. Claim 16 under nonstatutory obviousness-type double patenting
over claims 2, 10, 11, 14-20, 23, 31, 32, and 35-41 of U.S. Patent No.
6,656,720 in view of Nerome.
VI. Claims 16 and 20 under nonstatutory obviousness-type double
patenting over claims 3, 11, 12, and 15-20 of U.S. Patent No. 6,455,298 in
view of Nerome.

2 In the Non-Final Rejection of Feb. 1, 2011, claims 1, 4-7, 15, and 20-29
were rejected under 35 U.S.C. § 112, second paragraph (Non-Final Rej. 2).
However, the Examiner does not set forth this rejection in the Examiner’s
Answer. Thus, we understand that this rejection has been withdrawn. See
Paperless Accounting, Inc. v. Bay Area Rapid Transit Sys., 804 F.2d 659,
663 (Fed. Cir. 1986). Therefore, we do not further discuss this rejection
herein.
3 Smith et al., U.S. Patent No. 5,762,939, issued Jun. 9, 1998.
4 Kistner et al., U.S. Patent No. 5,756,341, issued May 26, 1998.
5 Nerome et al., The Multiplication of an Influenza C Virus in an Established
Line of Canine Kidney (MDCK) Cells, 39 J. GEN. VIROL. 179-181 (1978).
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VII. Claims 21-25 are patentable under nonstatutory obviousness-
type double patenting over claims 2, 10, 11, 14-20, 23, 31, 32, and 35-41 of
U.S. Patent No. 6,656,720 in view of Nerome, or claims 3, 11, 12, and 15-20
of U.S. Patent No. 6,455,298 in view of Nerome; and in further view of
Kistner.
VIII. Claims 1, 4-7, 15-16, and 20-29 under nonstatutory
obviousness-type double patenting over claims 1, 2, 4-10, l3-17, 20-24, and
26-29 of copending Patent Application No. 12/146,689.

I. The Issue: Obviousness over Smith and Kistner
The Examiner takes the position that Smith teaches culturing
influenza virus at reduced temperatures (33º C), in canine MDCK cell lines
in the presence of trypsin (Ans. 5). The Examiner recognizes that Smith
does not incubate the cells in serum-free medium, and thereby relies on
Kistner for this teaching (id.). The Examiner concludes that it would have
been “obvious to those in the art to combine the teachings of Kistner with
those of Smith such that the methods of replication disclosed in Smith was
performed in a serum-free culture medium to produce higher titers of virus.”
(Id.)
The issue is: Does the preponderance of evidence of record support
the Examiner’s position that the production of an influenza virus vaccine in
the MDCK cell line under low temperature conditions is obvious, and if so
has Appellant provided sufficient evidence to rebut the prima facie case?

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Findings of Fact
FF 1. Smith disclosed:
To propagate the original stock of influenza virus
obtained from the FDA, MDCK [Madin Darby Canine kidney]
cells were infected in the presence of TPCK-treated trypsin . . . .
The infected cells were incubated at 33° C. for 48 h, and media
was assayed for virus production using the hemagglutination
activity assay. The conditions yielding the highest HA activity
were used to prepare large stocks of influenza virus.
(Smith, col. 10, l. 64 to col. 11, l. 47, Example 1; see also col. 6, l. 55 to col.
7, l. 20; Ans. 4.)
FF 2. Kistner disclosed:
MDCK cells were grown as monolayers under serum-
free conditions (SF) or under conventional conditions in the
presence of 5% fetal calf serum (FCS) . . . . To demonstrate the
effect of trypsin on HA-titres all experiments were performed in
the absence of trypsin or in the presence of 0.002% trypsin . . . .
The data summarized . . . demonstrate that, as in the case
of CV-l cells and LLC-MK 2 cells, [in MDCK cells] maximum
HA-titres are obtained under serum-free conditions and in the
presence of trypsin.
(Kistner, col. 23, ll. 1-35; Ans. 5.)

Analysis
Appellant contends that “[b]y culturing the infected cells at 33° C,
Applicant has discovered that the vaccine formulated with the replicated
influenza virus is superior at protecting mammals from influenza virus than
vaccine produced from influenza virus that was replicated in cells cultured at
37° C.” (App. Br. 6.) “Surprisingly, the viruses grown at 33° C are much
more immunogenic than those grown at 37° C - Tables IV and V show that
the 33° C virus is 2 orders of magnitude better, and the protection
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experiments in Table IV show a very large difference in protective efficacy
(10% vs. 90% survival).” (Id. at 9.) Appellant further contends that Smith
“did not formulate a vaccine from the influenza virus replicated at 33°C.”
(Id.)
After considering the evidence and the arguments, we conclude the
evidence favors the Examiner’s conclusion of obviousness. Accordingly, we
adopt the Examiner’s reasoning (see Grounds of Rejection, Ans. 4-5; see
also FFs 1-2), and agree that the Examiner properly found Appellant’s
arguments unpersuasive (see Response to Argument, Ans. 8-14). We
provide the following points for emphasis.
In response to Appellant’s argument that Smith does not produce
vaccine form virus replicated at 33° C the Examiner finds that there is
nothing in Smith that would dissuade the artisan from using virus replicated
at 33° C (Ans. 11; FF 1). The law does not require that the teachings of the
reference be combined for the reason or advantage contemplated by the
inventor, as long as some suggestion to combine the elements is provided by
the prior art as a whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992);
In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976). Specifically, the
Examiner finds that
Contrary to Appellant’s assertions, the fact that Smith is not
using the culture of infected cells to produce a vaccine from the
replicated virus but to isolate the influenza DNA, does not
discourage the skilled artisan to use the temperature of 33° C
because this particular temperature was successfully used for

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production of the virus, regardless of the subsequent use of the
virus.
(Ans. 11.) Additionally, the Examiner notes that
Applicant has not shown that culturing the influenza virus
infected MDCK cells at 33° C in the serum-free medium result
in better virus titer or quality compared to culturing the virus
infected cells at 33° C in the presence of serum. Absent such
showing it is presumed that serum is not a variable affecting the
titer or quality of the virus.
(Ans. 13.) We agree with the Examiner’s conclusion that “the teachings of
the prior art references in combination would have yielded nothing more
than predictable results of replicating influenza virus at 33° C in serum-free
medium” with a reasonable expectation of producing a vaccine (Ans. 13;
FFs 1 & 2).
Because the Examiner presents a prima facie case of obviousness, we
consider whether Appellant submitted sufficient evidence or argument in
rebuttal. In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993).
Appellant contends that the Specification provides that “[i]t has
surprisingly been found that by the replication of the influenza viruses in
infected cells at reduced temperatures, viruses are obtained which have an
appreciably higher efficacy as vaccine than those viruses which are obtained
by replication at 37°C.” (Spec. 4-5; Reply Br. 7.) Appellant contends that
the Examiner has not provided a sound rational for concluding that
Appellant’s evidence of secondary consideration is not commensurate in
scope with the claims.
The Examiner takes the position that what is missing in Appellant’s
rebuttal is a showing “that culturing the influenza virus infected MDCK cells
at 33° C in the serum-free medium result in better virus titer or quality
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compared to culturing the virus infected cells at 33° C in the presence of
serum” (Ans. 13). We agree with the Examiner’s position that Appellant has
not established a nexus between the merits of the claims and the evidence
presented. “The mere recognition of . . . latent properties [in the prior art]
does not render the otherwise obvious [invention] unobvious”. In re
Prindle, 297 F.2d 251, 254 (CCPA 1962). Here the latent property is
antigen quality, in other words Applicant discovered that the antigen of the
virus grown at 33° C provides better protection when administered to a
mammal. Because Smith teaches the growth and production of influenza
virus grown at 33° C, the virus of Smith will also possess these qualities.
On the record before us, we conclude the Examiner did not err in
rejecting claims 1, 4-7, and 21 under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Smith and Kistner.

II. The Issue: Smith, Kistner, and Nerome
Appellant contends that he discovered superior protection in mammals
using influenza virus replicated at 33º C (App. Br. 12) and that the Examiner
has not provided a valid reason for combining Smith and Kistner (id.).
According to Appellant, Nerome “also only teach[es] culturing of the virus
at 37°C, so Nerome et al. also fail[s] to provide a reason to combine the
teachings of Smith et al., Kistner and Nerome et al.” (Id. at 13.)
As discussed above (I.) we have found no error in the Examiner’s
prima facie case obviousness with the combination of Smith and Kistner.
Appellant has not made separate argument for claims incorporating the
Nerome reference. Accordingly, Appellant has not apprised us of any error
in the Examiner’s findings other than asserting that the underlying
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combination of Smith and Kistner is in error. See In re Lovin, 652 F.3d
1349, 1357 (Fed. Cir. 2011). Assuming, arguendo, Appellant’s contention
regarding these claims rise to the level of separate argument, we adopt the
Examiner’s finding (Ans. 5-6) that Nerome discloses the additional
limitations with respect to claims 16 and 22-29.

III. The Issue: Nonstatutory Obviousness-Type Double Patenting over
U.S. Patent No. 6,656,720
Appellant contends that the Examiner has not established a prima
facie case of obviousness-type double patenting (App. Br. 13-14), and that it
is inappropriate for the Examiner to cite to the Specification for finding the
limitation of “culturing the infected cells at a temperature of 33° C,” citing
MPEP 804 and specifically General Foods Corp. v. Studiengesellschaft
Kohle mbH, 972 F.2d 1272, 1279 (Fed. Cir. 1992) in support of this position
(id.).
In response, the Examiner recognizes that MPEP 804 further provides
that there are situations when the Specification can be consulted in order to
provide support for the patent claims, specifically, this arises in situations
“when addressing the issue of whether a claim in the application defines an
obvious variation of an invention claimed in the patent. In re Vogel, 422
F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).” (Ans. 15.)
Claim 2 of the ’720 patent recites:
2. A process for the replication of influenza viruses in cell
culture, which comprises:
(i) proliferating MDCK cells wherein said cells can be
infected by influenza viruses, wherein said cells are adapted to
growth in suspension, and wherein said cells are adapted for
growth in serum-free medium;
(ii) infecting the cells with influenza viruses;
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(iii) shortly before infection, simultaneously to infection,
or shortly after infection, adding to the cell suspension a
protease to cleave the precursor protein of hemagglutinin; and
(iv) isolating the influenza viruses replicated in the cells.
Here, claim 2 of the ’720 patent does not recite the conditions for replication
the influenza viruses in the cell culture. Looking to the ’720 Specification to
determine the replication conditions for virus infected cells, one finds that
the cells are preferably incubated at 33º C. Specifically, the ’720
Specification provides that:
[E]xperiments confirm that influenza viruses which had been
replicated at 37° C. in cell culture with a high antigen yield (HA
titer) only induced a low neutralizing, antibody titer in the
mouse and barely provided protection, while influenza viruses
which had been replicated at 33° C. in cell culture also with a
high antigen yield (titer) induced very high neutralizing
antibody titers in the mouse and led to very good protection.
(U.S. Patent No. 6,656,720, col. 12, ll. 22-28.) We agree with Appellant’s
contention that “[t]he disclosure of a patent may not be used as prior art”
when considering double patenting (App. Br. 14 (emphasis omitted)). A
patent disclosure, however, may be used as a dictionary to learn the meaning
of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199
F.3d 1295, 1299 (Fed. Cir. 1999). In this instance, Examiner relied upon
’720 disclosure to learn the meaning of the “replication” condition, as that
term is used in the ’720 claims. As Appellant recognizes, the claims of ’720
patent do not recite the limitation of “culturing the infected cells at a
temperature of 33º C” (see Reply Br. 23), here, we find no error with the
Examiner’s consultation of the Specification to determine the “replication”
condition for the virus in the cell culture. The Examiner is not relying on
any broad assertions in the Specification, but instead is only looking to those
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parts of the Specification that support the patent claims and this use of the
Specification under Vogel is permissible. See In re Vogel, 422 F.2d at 442.
Accordingly, we affirm the Examiner’s rejection of claims 1, 4-7, and
16 under nonstatutory obviousness-type double patenting over U.S. Patent
No. 6,656,720.

IV. The Issue: The Issue: Nonstatutory obviousness-type double patenting
over U.S. Patent No. 6,455,298.
Appellant contends that the Examiner has not established a prima
facie case of obviousness-type double patenting (App. Br. 14-16), and that it
is inappropriate for the Examiner to cite to the Specification for finding the
limitation of “culturing the infected cells at a temperature of 33° C,” citing
MPEP 804 and specifically General Foods Corp. v. Studiengesellschaft
Kohle mbH, 972 F.2d at 1279 in support of this position (id. at 16.).
In response, the Examiner recognizes that MPEP 804 further provides
that there are situations when the Specification can be consulted in order to
provide support for the patent claims, specifically, this arises in situations
“when addressing the issue of whether a claim in the application defines an
obvious variation of an invention claimed in the patent. In re Vogel, 422
F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).” (Ans. 15.)
Claim 3 of the ’298 patent recites:
3. A process for the replication of influenza viruses in cell
culture, which comprises
(i) proliferating, in serum-free medium in suspension,
cells derived from cell line MDCK(ATCC CCL34
MDCK(NBL2)) which are adapted to growth in suspension in
serum-free medium and which can be infected with influenza
virus;
(ii) infecting the cells with influenza viruses;
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(iii) shortly before infection, simultaneously to infection
or shortly after infection adding to the cell suspension a
protease to cleave the precursor protein of hemagglutinin; and
(iv) after a further culturing phase, isolating the influenza
viruses replicated in the cells.
Here, claim 3 of the ’298 patent does not recite the conditions for the
“culturing phase” for the replication of influenza viruses. Looking to the
’298 Specification to determine the conditions of the “culturing phase” for
the virus production, one finds that the cells are preferably incubated at
33º C. Specifically, the ’298 Specification provides that:
[E]xperiments confirm that influenza viruses which had been
replicated at 37° C. in cell culture with a high antigen yield (HA
titer) only induced a low neutralizing, antibody titer in the
mouse and barely provided protection, while influenza viruses
which had been replicated at 33° C. in cell culture also with a
high antigen yield (titer) induced very high neutralizing
antibody titers in the mouse and led to very good protection.
(U.S. Patent No. 6,656,720, col. 12, ll. 24-31.) We agree with Appellant’s
contention that “[t]he disclosure of a patent may not be used as prior art”
when considering double patenting (App. Br. 16 (emphasis omitted); see
also Reply Br. 23). A patent disclosure, however, may be used as a
dictionary to learn the meaning of a term in the patent claim. Toro, 199 F.3d
at 1299. In this instance, Examiner relied upon ’298 disclosure to learn the
meaning of the “culturing phase,” as that term is used in the ’298 claims. As
Appellant recognizes, the claims of ’298 patent do not recite the limitation of
“culturing the infected cells at a temperature of 33º C” (see Reply Br. 23),
here, we find no error with the Examiner’s consultation of the Specification
to determine the “culturing phase” condition for the virus in the cell culture.
The Examiner is not relying on broad assertions in the Specification, but
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instead is only looking to those parts of the Specification that support the
patent claims and this use of the Specification under Vogel is permissible.
See In re Vogel, 422 F.2d at 442.
Accordingly, we affirm the Examiner’s rejection of claims 1, 4-7, and
15 under nonstatutory obviousness-type double patenting over U.S. Patent
No. 6,455,298.

V. The Issue: Nonstatutory Obviousness-Type Double Patenting of U.S.
Patent No. 6,656,720 in view of Nerome.
As discussed above (III.) we have found no error in the Examiner
prima facie case nonstatutory obviousness-type double patenting over U.S.
Patent No. 6,656,720. Appellant has not made separate argument for claims
incorporating the Nerome reference. Accordingly, Appellant has not
apprised us of any error in the Examiner’s findings other than asserting that
the underlying rejection based on U.S. Patent No. 6,656,720 is in error.
Assuming, arguendo, Appellant’s contention regarding these claims rise to
the level of separate argument, we adopt the Examiner’s finding (Ans. 7,
15-16) that Nerome discloses the additional limitations with respect to
claim 16.

VI-VII. The Issue: Nonstatutory Obviousness-Type Double Patenting
over U.S. Patent No. 6,455,298 in view of Nerome, or in view of Nerome and
Kistner.
As discussed above (IV.) we have found no error in the Examiner’s
prima facie case nonstatutory obviousness-type double patenting over U.S.
Patent No. 6,455,298. Appellant has not made separate argument for claims
incorporating the Nerome or Kistner reference. Accordingly, Appellant has
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not apprised us of any error in the Examiner’s findings other than asserting
that the underlying rejection based on U.S. Patent No. 6,455,298 is in error.
Assuming, arguendo, Appellant’s contention regarding these claims rise to
the level of separate argument, we adopt the Examiner’s finding (Ans. 7,
15-16) that Nerome and Kistner discloses the additional limitations with
respect to claims 16 and 20-25.

VIII. The Issue: Nonstatutory Obviousness-Type Double Patenting over
claims 1, 2, 4-10, l3-17, 20-24, and 26-29 of co-pending Patent Application
No. 12/146,689.
Appellant contends that the Examiner has not established a prima
facie case of obviousness-type double patenting (App. Br. 19-20).
In response, the Examiner recognizes that MPEP 804 provides that
there are situations when the Specification can be consulted in order to
provide support for the patent claims, specifically, this arises in situations
“when addressing the issue of whether a claim in the application defines an
obvious variation of an invention claimed in the patent. In re Vogel, 422
F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).” (Ans. 15.)
Current claim 1 of the co-pending application 12/146,689, as amended on
June 16, 2011, recites:
Claim 1: A process for making a vaccine for administration to
humans or animals, the process comprising:
(a) incubating cells in a serum-free medium, wherein the
cells are animal cells that can be infected with influenza viruses
and are adapted for growth in suspension in serum-free media;
(b) adding influenza viruses to the serum-free medium to
infect the cells incubated in step (a), wherein protease is present
in the serum-free medium or added to the serum-free
medium before, during, or after infection with the influenza
viruses;
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(c) culturing the cells infected in step (b) in suspension to
replicate the influenza viruses;
(d) isolating the influenza viruses replicated in step (c);
and
(e) formulating the influenza viruses isolated in step (d)
to provide the vaccine, wherein the vaccine contains
disintegrated viruses.
Here, claim 1 of the co-pending application 12/146,689 does not recite the
conditions for “culturing the cells” infected with influenza virus. Looking to
the Specification of co-pending application 12/146,689 to determine the
conditions for “culturing the cells” for the virus production, one finds that
the cells are preferably incubated at 33º C. Specifically, the Specification
co-pending application 12/146,689 provides that:
[E]xperiments confirm that influenza viruses which had been
replicated at 37° C. in cell culture with a high antigen yield (HA
titer) only induced a low neutralizing, antibody titer in the
mouse and barely provided protection, while influenza viruses
which had been replicated at 33° C. in cell culture also with a
high antigen yield (HA titer) induced very high neutralizing
antibody titers in the mouse and led to very good protection.
(Specification co-pending application 12/146,689, 22: ¶ 0045.) A patent
disclosure may be used as a dictionary to learn the meaning of a term in the
patent claim. Toro, 199 F.3d at 1299. In this instance, Examiner relied upon
the disclosure of the co-pending application to learn the meaning of the term
“culturing the cells,” as that term is used in the application. We find no error
with the Examiner’s consultation of the Specification to determine the
conditions for “culturing the cells” for the virus production in the cell
culture.

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SUMMARY
We affirm the rejection of claims 1, 4-7, and 21 under 35 U.S.C.
§ 103(a) over Smith in view of Kistner.
We affirm the rejection of claims 16 and 22-29 under 35 U.S.C.
§ 103(a) over Smith in view of Kistner, and in further view of Nerome.
We affirm the rejection of claims 1, 4-7, and 16 under nonstatutory
obviousness-type double patenting over claims 2, 10, 11, 14-20, 23, 31, 32,
and 35-41 of U.S. Patent No. 6,656,720.
We affirm the rejection of claims 1, 4-7, and 15 under nonstatutory
obviousness-type double patenting over claims 3, 11, 12, and 15-10 of U.S.
Patent No. 6,455,298.
We affirm the rejection of claim 16 under nonstatutory obviousness-
type double patenting over claims 2, 10, 11, 14-20, 23, 31, 32, and 35-41 of
U.S. Patent No. 6,656,720 in view of Nerome.
We affirm the rejection of claims 16 and 20 under nonstatutory
obviousness-type double patenting over claims 3, 11, 12, and 15-20 of U.S.
Patent No. 6,455,298 in view of Nerome.
We affirm the rejection of claims 21-25 are patentable under
nonstatutory obviousness-type double patenting over claims 2, 10, 11, 14-20,
23, 31, 32, and 35-41 of U.S. Patent No. 6,455,298 in view of Nerome and in
further view of Kistner.
We affirm the rejection of claims 1, 4-7, 15-16, and 20-29 under
nonstatutory obviousness-type double patenting over claims 1, 2, 4-10, l3-
17, 20-24, and 26-29 of copending Patent Application No. 12/146,689.

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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

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