Ex Parte Horn et al

Board of Patent Appeals and Interferences

Sep 13, 2011

10375657 (B.P.A.I. Sep. 13, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/375,657 02/27/2003 Michael Horn 10041 6766
7590 09/13/2011
Patricia A. Sweeney
1835 Pleasant St.
West Des Moines, IA 50265-2334
EXAMINER
WORLEY, CATHY KINGDON
ART UNIT PAPER NUMBER
1638
MAIL DATE DELIVERY MODE
09/13/2011 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MICHAEL HORN, STEPHEN STREATFILED,
and JOSEPH JILKA
__________

Appeal 2010-003037
Application 10/375,657
Technology Center 1600
__________

Before LORA M. GREEN, FRANCISCO C. PRATS, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a plant
expressing an SIV or HIV protein. The Patent Examiner rejected the claims
for containing new matter and for obviousness. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.
Appeal 2010-003037
Application 10/375,657

2
STATEMENT OF THE CASE
Claims 1, 2, 4-19, and 24-26, which are all the pending claims, are on
appeal. Claims 1 and 9 are representative and read as follows:
1. A monocotyledonous plant comprising plant cells expressing a nucleic
acid encoding a simian or human immunodeficiency virus surface
protein wherein the nucleic acid is codon optimized for expression in
the plant, is operably linked to a promoter preferentially directing
expression to seed cells of the plant, and is operably linked to a
second nucleic acid, said second nucleic acid encoding a signal
sequence directing expression to the cell wall.

9. The plant of claim 1 wherein the plant is a progeny plant of a first
plant selected from a biomass comprising a plurality of plants,
wherein at least some of the plants of the plurality express the first
and second nucleic acid, the first plant expressing the surface protein
at higher levels than other plants of the plurality, and wherein the
surface protein is expressed in the progeny plant at levels of at least
about 0.1 % total soluble protein.

The Examiner rejected the claims as follows:
• claims 9-15 and 24 under 35 U.S.C. § 112, first paragraph, as
containing new matter; and
• claims 1, 2, 4-19, and 24-26 under 35 U.S.C. § 103(a) as
unpatentable over Fischer,
1
Mossman,
2
Horvath,
3
and Jensen.
4

1
Rainer Fischer et al., Molecular farming of pharmaceutical proteins,
9 TRANSGENIC RES. 279-299 (2000).
2
Sally P. Mossman et al., Protection against Lethal Simian
Immunodeficiency Virus SIVsmmPBj14 Disease by a Recombinant Semliki
Forest Virus gp160 Vaccine and by a gp120 Subunit Vaccine, 70 J. VIROL.
1953-1960 (1996).
3
Henriette Horvath et al., The production of recombinant proteins in
transgenic barley grains, 97 PROC. NAT‟L ACAD. SCI. 1914-1919 (2000).
Appeal 2010-003037
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NEW MATTER
The Issue
The Examiner‟s position is that the claims were amended using
limitations that introduce new matter. (Ans. 5.) More specifically, the
Examiner contends that the limitation “a first plant selected from a biomass
comprising a plurality of plants” added to claims 9-15, and the limitation “a
first plant cell selected from a plurality of plant cells” added to claim 24, do
not find support in the Specification as filed, including the original claims.
(Id.)
Appellants contend that the Specification has multiple sections
supporting the claims. (App. Br. 5, citing pages and lines.) According to
Appellants, “a fair reading of the specification shows Applicant clearly
considered selecting for high expressors of a population of plants.” (Id.at 6.)
“The specification discusses techniques for selection throughout and it was
contemplated as evidenced by a reading of the entire specification, and, in
particular, those excerpts above.” (Id. at 7.) Also relying on an
incorporation of US Patent No. 5,767,379 by reference, Appellants argue
that an example method described in that patent shows that “one could elect
to simply harvest an entire population without selecting but one could also
select for a plants [sic] and further propagation of a population of high
expressors.” (Id. at 6-7.)
The issues with respect to this rejection are:

4
Lisbeth Gath Jensen et al., Transgenic barley expressing a protein-
engineered, thermostable (1,3-1,4)-β-glucanase during germination,
93 PROC. NAT‟L ACAD. SCI. 3487-3491 (1996).
Appeal 2010-003037
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did the Specification as filed describe a progeny plant or cell of a first
plant or cell selected from a biomass comprising a plurality of plants or
cells, the first plant or cell expressing the surface protein at higher levels
than other plants or cells of the plurality; or
did the Specification incorporate the „379 patent‟s example method by
reference?

Findings of Fact
1. The Specification states: “all references cited herein are incorporated
herein by reference.” (Spec. 2, ll. 2-3.)
2. The Specification cited US Patent No. 5,767,379 in a paragraph
reading:
Numerous genes have been cloned into a variety of transgenic plants
including many enzymes that have demonstrated the same enzymatic
activity as their authentic counterparts. See, for example, expression
of avidin in plants, U.S. Patent No. 5,767,379; aprotinin expressed in
plants, U.S. Patent No. 5,824,870 and proteases expressed in plants,
U.S. Patent No. 6,087,558.; Hood [et al.], Commercial production of
avidin from transgenic maize . . . [citation omitted]; Pen, J. [et al.],
Production of active Bacillus licheniformis α-amylase in tobacco . . .
[citation omitted]; Trudel, J., [et al.] Expression of active hen egg
white lysozyme in transgenic tobacco [citation omitted]. Many
additional genes have been expressed in plants solely for their
immunogenic potential, including viral proteins (U.S. Patent Nos
6,034,298; 6,136,320; 5,914,123 and 5,484,719(TGEV and hepatitis
B); Mason et al, (1998) supra; Wigdorovitz, supra; Kapusta, et al,
supra; McGarvey, P.B., J. Hammond, M.M. Dienelt, D.C. Hooper,
Z.F. Fu, B. Dietzschold, H. Koprowski, and F.H. Michaels. 1995.
Expression of the rabies virus glycoprotein in transgenic tomatoes.
Biotechnology 13:1484-1487; Thanavala, Y., Y.-F. Yang, P. Lyons,
H. S. Mason, and C. J. Arntzen. 1995. Immunogenicity of transgenic
plant-derived hepatitis B surface antigen. Proc. Natl. Acad. Sci. U S. A
92:3358-3361 ) and subunits of bacterial toxins (Arakawa, T., D.K.
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Chong, J.L. Merritt, W.H. Langridge. 1997. Expression of cholera
toxin B subunit oligomers in transgenic potato plants. Transgenic Res.
6:403-413; Arakawa, T., J. Yu, and W. H. Langridge. 1999. Food
plant-delivered cholera toxin B subunit for vaccination and
immunotolerization. Adv. Exp. Med. Biol. 464:161-178; Haq, T. A.,
H. S. Mason, J. Clements, and C. J. Arntzen. 1995. Production of an
orally immunogenic bacterial protein in transgenic plants: proof of
concept of edible vaccines. Science 268:714-716). Animal and human
immunization studies have demonstrated the effectiveness of many
plant derived recombinant antigens in stimulating the immune system.
The production of antigen-specific antibodies and protection against
subsequent toxin or pathogen challenge demonstrates the feasibility of
plant derived-antigens for immunologic use.

(Id. at 3-4.)
3. Appellants direct attention to several passages in the Specification,
including:
The levels of expression of the gene of interest can be enhanced
by the stable maintenance of a protein encoding gene on a
chromosome of the transgenic plant. Use of linked genes, with
herbicide resistance in physical proximity to the enzyme encoding
gene, would allow for maintaining selective pressure on the
transgenic plant population and for those plants where the genes of
interest are not lost.
. . . Thus, the selection and propagation techniques described
above yield a plurality of transgenic plants which are harvested in a
conventional manner. . . .
. . . Thus, a minimum level of expression is required for the
process to be economically feasible. For the relatively small number
of transgenic plants that show higher levels of expression, a genetic
map can be generated, via conventional RFLP and PCR analysis,
which identifies the approximate chromosomal location of the
integrated DNA molecule. . . .

(App. Br. 5, quoting Spec. 16-17, Appellants‟ emphasis.)

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Principles of Law
Where a textual description of an embodiment is absent, a showing
that the missing description would have been obvious does not suffice.
Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997)
(“Entitlement to a filing date does not extend to subject matter which is not
disclosed, but would be obvious over what is expressly disclosed. It extends
only to that which is disclosed.”).
“To incorporate material by reference, the host document must
identify with detailed particularity what specific material it incorporates and
clearly indicate where that material is found in various documents.”
Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed.
Cir. 2000). The standard is whether one reasonably skilled in the art would
understand the application as describing with sufficient particularity the
material to be incorporated. Zenon Environmental, Inc. v. U.S. Filter Corp.,
506 F.3d 1370, 1378-79 (Fed. Cir. 2007) (applying the Advanced Display
standard and concluding that the material incorporated by reference was not
the detail at issue but a separate and distinct element of the invention from
that argued). Every concept of the incorporated patent is not necessarily
imported. See Modine Mfg. Co. v. U.S. Int'l Trade Comm'n, 75 F.3d 1545,
1553 (Fed. Cir. 1996) (“[I]ncorporation by reference does not convert the
invention of the incorporated patent into the invention of the host patent”),
overruled on other grounds by Festo Corp. v. Shoketsu Kinzoku Kogyo
Kabushiki Co., Ltd., 234 F.3d 558 (Fed. Cir. 2000).

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Analysis
Having reviewed the evidence and arguments, we find that a
preponderance of the evidence supports the Examiner‟s findings. (See Ans.
5 and 11-12.) Summarizing: the Specification did not describe, explicitly or
implicitly, a progeny plant resulting from first selecting a high expressor (a
“first plant” or “first plant cell”) and then producing the progeny plant from
the selected high expressor plant or plant cell. After reviewing the passages
Appellants cited, we also agree with the Examiner‟s analysis of those
passages: they apply selection to other objects and processes, and none of
the passages describe a process of selecting a high expressor plant out of the
population for progeny production. That is, the cited passages pertain to
selections of other things.
Appellants contend that “a fair reading of the specification shows
Applicant clearly considered selecting for high expressors of a population of
plants.” (App. Br. 6.) We disagree that the Specification described selecting
a high expressor from the population and using the selected plant for
propagation. The Specification described selecting high expressor
populations and population level propagation, not selection of a plant from
the population and propagation of the selected plant. (See, e.g., passage
quoted in FF 3.) Even if Applicant “considered” selecting a high expressor
plant from a population, Appellants have not identified an explicit
consideration, and the concept was not described implicitly either. If it
would have been obvious to build on the invention that was in fact
described, and to make the invention now claimed, that kind of obvious
variation was not described. See Lockwood, 107 F.3d at 1571-72.
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We agree with Appellants that the Specification incorporated by
reference all the references it cited, including the „379 patent. (FF 1.) While
the Examiner erred on that point (Ans. 12, “there was no specific
incorporation by reference for US Patent 5,767,379”), that error was
harmless, as we next discuss.
Appellants provide an excerpt from column 3 of the „379 patent, said
to describe an example method. (App. Br. 6-7.) The Examiner found,
however, that “there was no particular reference to Column 3, lines 12-33, of
US Patent 5,767,379, which includes the particular step of selecting at least
one plant for further propagation based on assessment of expression level for
the gene desired to be expressed at high levels.” (Ans. 12.) The Examiner is
correct: Appellants‟ Specification cited the „379 patent solely as evidence
that the enzyme avidin had been expressed in plants. (FF 2.)
The standard for deciding whether the „379 example method was
incorporated is whether one reasonably skilled in the art would understand
Appellants‟ Specification as referencing with sufficient particularity that
example method. Zenon, 506 F.3d at 1378-79. Because Appellants‟
Specification cited the „379 patent only as evidence that avidin had been
expressed in plants, we agree with the Examiner that because the example
method was not referenced, more particular reference to the „379 example
method would have been required to incorporate the method. Id.; see also
Modine, 75 F.3d at 1553 (Fed. Cir. 1996).

OBVIOUSNESS
After weighing the evidence and arguments presented by Appellants
and the Examiner, we conclude that the Examiner is correct. We adopt the
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Examiner‟s findings and conclusions set out in the “Grounds of Rejection”
and in the “Response to Argument” at Ans. 5-11 and 11-21.

SUMMARY
We affirm the rejection of claims 9-15 and 24 under 35 U.S.C. § 112,
first paragraph, as containing new matter.
We affirm the rejection of claims 1, 2, 4-19, and 24-26 under
35 U.S.C. § 103(a) as unpatentable over Fischer, Mossman, Horvath, and
Jensen.

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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