Ex Parte Houghton et al

Patent Trial and Appeal Board

Mar 8, 2016

12622087 (P.T.A.B. Mar. 8, 2016)

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.
12/622,087 11/19/2009 Alan N. Houghton MSK.P-026-5 3700
52334 7590 03/08/2016
Larson & Anderson, LLC
re: MSK
P. O. BOX 4928
DILLON, CO 80435-4928
EXAMINER
RAWLINGS, STEPHEN L
ART UNIT PAPER NUMBER
1643
MAIL DATE DELIVERY MODE
03/08/2016 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ALAN N. HOUGHTON,
CLARISSA C. NAFTZGER, and SETALURI VIJAYASARADHI
__________

Appeal 2013-009586
Application 12/622,087
Technology Center 1600
__________

Before DEMETRA J. MILLS, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134 involving claims to a
method for stimulating an immune response. The Examiner rejected the
claims as indefinite, as failing to comply with the written description
requirement, as anticipated, as obvious, and on the ground of obviousness-
type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm-in-part.

1 Appellants identify the Real Party in Interest as Sloan Kettering
Institute for Cancer Research (see Br. 1).
2 We note that this case is related to Appeals 2008-4403 and 2008-
4425 (see Br. 1).
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Statement of the Case
Background
“Differentiation antigens have been shown to be expressed by a
variety of tumor types, including melanoma . . . . For example,
differentiation antigens expressed by melanoma cells include . . . Pmel17 . . .
gp75 and gp100” (Spec. 2, ll. 7–13). “Unfortunately, in most cases, the
immune system of the individual is tolerant of these antigens, and fails to
mount an effective immune response” (Spec. 2, ll. 21–22). “It has now been
found that the tolerance of the immune system for endogenous gp100 can be
overcome and an immune response stimulated by administration of
xenogeneic gp100 and gp100 (including syngeneic gp100) expressed in cells
of different species” (Spec. 3, ll. 6–9).
The Claims
Claims 1–3, 5, 6, 8–10, 14, and 15 are on appeal.3 Independent claim
1 is representative and reads as follows:
1. A method for stimulating an immune response to a
syngeneic tissue expressing melanosomal gp100 in a subject
individual of a first species, comprising administering to the
subject individual an immunologically-effective amount of
xenogeneic melanosomal gp100 antigen, wherein the
xenogeneic melanosomal gp100 antigen is adminstered [sic]
by DNA immunization of the subject with DNA encoding
the melanosomal gp100 antigen in a non-viral plasmid
vector comprising DNA encoding the melanosomal gp100
antigen under the control of a promoter which promotes
expression thereof.

3 Claims 4, 7, and 11–13 were cancelled (see Response to Non-
final Action 2/24/2012).
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The Issues4
A. The Examiner denied priority to US application 09/308,697, which is
a national stage entry of PCT/US97/226695 (Final Rej. 2–5).
B. The Examiner rejected claims 1–3, 5, 6, 8–10, 14, and 15 under
35 U.S.C. § 112, second paragraph as being indefinite (Final Rej. 5–8).
C. The Examiner rejected claims 1–3, 5, 6, 8–10, 14, and 15 under
35 U.S.C. § 112, first paragraph as failing to comply with the written
description requirement (Final Rej. 9–11).
D. The Examiner rejected claims 1, 8–10, and 156 as anticipated under
35 U.S.C. § 102(b) by Zhai (1996)7 (Final Rej. 12).
E. The Examiner rejected claims 1–3 and 14 under 35 U.S.C. § 103(a) as
obvious over Zhai (1996) and Zhai (1997)8 (Final Rej. 13–16).
F. The Examiner rejected claims 1 and 5 under 35 U.S.C. § 103(a) as
obvious over Zhai (1996), Zhai (1997), and Zhou9 (Final Rej. 16–17).

4 The obviousness-type double patenting rejection over US
Application 12/622,103 is moot in view of the abandonment of that
application.
5 PCT/US97/22669, publication number WO 98/25574 A2,
international filing date 10 December 1997, published 18 June
1998.
6 As claims 4 and 11 are cancelled claims, to the extent that they
are listed as rejected, such rejections are not addressed.
7 Zhai et al., Antigen-Specific Tumor Vaccines Development and
Characterization of Recombinant Adenovirus Encoding MART1 or
gp100 for Cancer Therapy, 156 J. IMMUN. 700–710 (1996)
8 Zhai et al., Cloning and Characterization of the Genes Encoding
the Murine Homologues of the Human Melanoma Antigens
MART1 or gp100, 1 J. IMMUNOTHER. 15–25 (1997) (We use the
page numbering in the reference with pages 1–18)
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G. The Examiner rejected claims 1 and 6 under 35 U.S.C. § 103(a) as
obvious over Zhai (1996), Zhai (1997), and Sundaram10 (Final Rej. 17–18).
H. The Examiner rejected claim 1, 5, 6, and 8–10 under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1–10 of U.S. Patent No. 7,556,80511 (Final Rej. 18–19).
A. Priority
The Examiner finds that “the claimed invention is not adequately
described in the earlier filed applications (i.e., Provisional Application No.
60/036,419, PCT/US97/722669 [published as Houghton et al., WO
98/25574, on June 18, 1998]” (Final Rej. 3).
The issue with respect to priority is: Does the evidence of record
support the Examiner’s finding that the claims are not entitled to priority to
PCT/US97/722669?
Findings of fact
1. PCT/US97/22669 teaches “differentiation antigens expressed
by melanoma cells include . . . Pmel17” (PCT/US97/22669 1, ll. 9–10; cf.

9 Zhou et al., Protective Immunization Against Melanoma by
gp100 DNA-HVJ-Liposome Vaccine, 6 GENE THER. 1768–1773
(1999).
10 Sundaram et al., Particle-Mediated Delivery of Recombinant
Expression Vectors to Rabbit Skin Induces High-Titered
Polyclonal Antisera (and Circumvents Purification of a Protein
Immunogen), 7 NUCLEIC ACIDS RES. 1375–1377 (1996).
11 U.S. patent No. 7,556,805, issued July 7, 2009.
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Spec. 2, ll. 11–13). We take notice that Pmel17 is an alternate name for
gp100.12
2. PCT/US97/22669 teaches that “[f]or treatment of humans with
a syngeneic differentiation antigen, cDNA encoding the human
differentiation antigen to be targeted must be available. . . . Other human
differentiation antigens with known cDNA sequences are gp100” (id. at 5, ll.
5–15; cf. Spec. 9, ll. 13–16).
3. PCT/US97/22669 teaches that:
In accordance with the present invention, an immune
response against a target differentiation antigen can be
stimulated by the administration of xenogeneic
differentiation antigen of the same type. . . .
Xenogeneic differentiation antigen may be
administered as a purified differentiation antigen derived
f[ro]m the source organism. . . . Nucleic acid sequences of
various differentiation antigens from various non-human
sources are known, including . . . mouse gp100

(id. at 7, ll. 1–15; cf. Spec. 5, ll. 1–11).
Principles of Law
Under 35 U.S.C. § 120, “in a chain of continuing applications, a claim
in a later application receives the benefit of the filing date of an earlier
application so long as the disclosure in the earlier application meets the
requirements of 35 U.S.C. § 112, ¶ 1, including the written description
requirement, with respect to that claim.” Tech. Licensing Corp. v. Videotek,
Inc., 545 F.3d 1316, 1326 (Fed. Cir. 2008).

12 See http://www.genecards.org/cgi-bin/carddisp.pl?
id_type=entrezgene&id=6490 (accessed Feb. 29, 2016).
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Analysis
We find that Appellants have the better position regarding priority.
Specifically, PCT/US97/22669 teaches gp100 as a differentiation antigen
that is expressed by melanoma cells (FF 1), teaches treatment of humans
with syngeneic differentiation antigens including gp100 (FF 2), and teaches
that stimulation of an immune response can be accomplished with a
xenogeneic differentiation antigen, such as mouse gp100 (FF 3).
Conclusion of Law
The evidence of record does not support the Examiner’s finding that
the claims are not entitled to priority to PCT/US97/722669.
Therefore, Zhou is not available as a prior art reference.

B. and C. 35 U.S.C. § 112, first paragraph, written description and
second paragraph, indefiniteness
Because the issues of indefiniteness and descriptive support are
intertwined in this application, with the same terms rejected as indefinite and
as lacking descriptive support, we will consider these two issues together.
The issues with respect to these rejections are:
(i) Does the evidence of record support the Examiner’s finding that
the terms “melanosomal gp100,” “non-viral,” “syngeneic,” and “reduction in
growth of tumors” are indefinite?
(ii) Does the evidence of record support the Examiner’s finding that
the terms “melanosomal gp100,” “non-viral,” “syngeneic,” and “reduction in
growth of tumors” lack descriptive support in the Specification?
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Findings of Fact
“melanosomal gp100”
4. The Specification discloses the human gp100 sequence,
teaching that “[t]he sequence of Human gp100 is known from Adema G et
al., Molecular Characterization of the Melanocyte Lineage-specific Antigen
gp100, 269 J. BIOL. CHEM. 20126 (1994)” (Spec. 12, l. 18 to 14, l. 11).
5. The Specification discloses the mouse gp100 sequence,
teaching that “[t]he cDNA for mouse gp100 was isolated and cloned into a
vector in Adema G, et al, Melanocyte Lineage-Specific Antigens Recognized
by Monoclonal Antibodies NKI-beteb, HMB-50, and HMB-45 are Encoded
by a Single cDNA, 143 Amer. J. of Pathology 1579 (1993)” (Spec. 14, l. 13
to 16, l. 3).
“non-viral plasmid vector”
6. The Specification teaches that:
Xenogeneic gp100 antigen may also be administered
indirectly through genetic immunization of the subject with
DNA encoding the antigen. cDNA encoding the xenogeneic
gp100 antigen is combined with a promoter which is
effective for expression of the cDNA in mammalian cells.
This can be accomplished by digesting the nucleic acid
polymer with a restriction endonuclease and cloning into a
plasmid containing a promoter such as the SV40 promoter,
the cytomegalovirus (CMV) promoter or the Rous sarcoma
virus (RSV) promoter. . . . The cDNA can also be cloned
into plasmid and viral vectors that are known to transduce
mammalian cells.

(Spec. 7, ll. 1–9).
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“syngeneic”
7. The Specification teaches that “[t]he term ‘xenoexpressed’
refers to an antigen which may be syngeneic with the subject individual, but
which is expressed in cells of a species different from the subject individual,
for example in insect cells” (Spec. 5, ll. 8–11).
“reduction in growth of tumors”
8. The Specification teaches that: “[p]referably, the immune
response is sufficient to provide immunoprotection against growth of tumors
expressing gp100” (Spec. 4, ll. 20–22).
Principles of Law
“[W]e read § 112, ¶ 2 to require that a patent’s claims, viewed in light
of the specification and prosecution history, inform those skilled in the art
about the scope of the invention with reasonable certainty.” Nautilus, Inc. v.
Biosig Instruments, Inc., 134 S. Ct. 2120, 2129 (2014).
“[I]t is the specification itself that must demonstrate possession. And
while the description requirement does not demand any particular form of
disclosure, . . . or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement” Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.,
598 F.3d 1336, 1352 (Fed. Cir. 2010).
Analysis
“melanosomal gp100”
The Examiner finds the term “melanosomal gp100” indefinite because
it “does not identify any one particular antigen but rather any of a plurality
of glycoproteins having a molecular weight of 100 kDa, which is of or from
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a melanosome (i.e., a cellular organelle containing melanin)” (Ans. 17). The
Examiner also finds that the “term ‘melanosomal’ does not appear in the
specification. Moreover, the term is not used to describe the origin or source
of the claimed gp100 or gp100 antigen” and is “not adequately supported by
the specification” (Ans. 47).
We are not persuaded. We agree with Appellants that “the Examiner
offers no evidence that . . . the person skilled in the art would not understand
what is meant by the term by a person skilled in the art who has read the
specification” (Br. 4). The Specification refers to gp100 as a differentiation
antigen expressed by melanoma cells, making it explicit that “melanosomal”
refers to melanoma and thereby providing descriptive support for this term
(FF 1).
In addition, the Specification further teaches that the sequences of
human and mouse gp100 were known (FF 4–5), evidencing that gp100 is a
definite term that refers to a particular known glycoprotein that is described
in the Specification. See Falko-Gunter Falkner v. Inglis, 448 F.3d 1357,
1368 (Fed. Cir. 2006) (“[W]e hold that where, as in this case, accessible
literature sources clearly provided, as of the relevant date, genes and their
nucleotide sequences (here ‘essential genes’), satisfaction of the written
description requirement does not require either the recitation or
incorporation by reference (where permitted) of such genes and
sequences.”).
“non-viral plasmid vector”
The Examiner finds that the term “non-viral plasmid vector” is
indefinite because “it cannot be ascertained what does or does not constitute
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a ‘non-viral plasmid vector’” (Ans. 32). The Examiner also finds that the
“term ‘non-viral’ is not used in the specification, and particularly not to
describe a plasmid or vector known to transduce mammalian cells” (Ans.
57).
We are not persuaded. We find that the ordinary artisan would
reasonably interpret “non-viral plasmid vector” as a plasmid vector not used
for viral packaging, consistent with the teaching in the Specification that
“cDNA can also be cloned into plasmid and viral vectors that are known to
transduce mammalian cells” (FF 6). Moreover, the disclosure of both
plasmid and viral vectors by the Specification evinces a recognition that
these are two distinct types of vectors, reasonably providing descriptive
support for plasmid vectors that are “non-viral,” that is vectors that do not
express viral genes and infect cells. Therefore, the term “non-viral” is also
not indefinite, because the ordinary artisan would reasonably interpret the
phrase solely to exclude vectors that express viral genes and infect cells, as
distinct from plasmid vectors that do not infect cells, but may encompass
viral promoters.
“syngeneic”
The Examiner finds that the term “syngeneic” is indefinite because
“the claims do not clearly and particularly delimit the subject matter that is
regarded as the invention” (Ans. 40). The Examiner also finds that “the term
‘syngeneic’ is not used in the specification to describe a tissue expressing
melanosomal gp100 in a subject individual; rather it appears that the term is
only used by the specification to describe the antigen. Therefore, it appears
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that the amendment has introduced new concepts not adequately supported
by the specification” (Ans. 51).
We recognize that “syngeneic” may be used in the other contexts such
as that of transplantation, but agree with Appellants that Examiner has
“failed to consider the term in the context of the present invention” (Br. 6).
We agree that in this context syngeneic is reasonably interpreted as referring
“to differentiation antigens that are syngeneic with respect to the individual
to be treated . . . . The term is included to make a distinction between the
antigen of these cells and the xenogeneic antigen (from another species) that
is administered” (Br. 6; FF 7).
That is, the skilled artisan would understand, with reasonable
certainty, that the “syngeneic” tissue in the Specification refers to cancer
tumor tissue that shares the same genetic background as the patient and
expresses the gp100 protein native to the patient, while the xenogeneic
gp100 that is administered refers to gp100 from a different species than the
patient. Moreover, Appellants usage of “syngeneic” is consistent with the
usage by prior art references applied by the Examiner (see Zhai (1997),
abstract “[t]o develop a syngeneic animal model for evaluating antigen-
specific vaccines”).
“reduction in growth of tumors”
The Examiner finds that “to provide a reduction in growth of tumors
expressing gp100” is indefinite because “it cannot be ascertained what result
or effect must be achieved” (Ans. 40). The Examiner finds that “the term
‘reduction’ does not appear in the specification and moreover it does not
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appear that the specification describes any process that results in reduced
growth of tumors expressing melanosomal gp100” (Ans. 59).
We are not persuaded by the Examiner. With regard to the
indefiniteness argument, ‘“[b]readth is not indefiniteness.’” SmithKline
Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1341 (Fed. Cir. 2005). Any
change in tumor size or prevention of tumor growth is reasonably
encompassed by the claim language.
We recognize that the word “reduction” is not used by the disclosure
as filed in ipsis verbis, but agree with Appellants that written description
support is found in the Specification, which provides, inter alia, that “the
immune response is sufficient to provide immunoprotection against growth
of tumors expressing gp100” (Br. 9; FF 8). The elements must be arranged
as required by the claim, but this is not an ipsissimis verbis test, i.e., identity
of terminology is not required. In re Bond, 910 F.2d 831, 832 (Fed. Cir.
1990).
Conclusions of Law
(i) The evidence of record does not support the Examiner’s finding
that the terms “melanosomal gp100,” “non-viral,” “syngeneic,” and
“reduction in growth of tumors” are indefinite.
(ii) The evidence of record does not support the Examiner’s finding
that the terms “melanosomal gp100,” “non-viral,” “syngeneic,” and
“reduction in growth of tumors” lack descriptive support in the
Specification.
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D. 35 U.S.C. § 102(b) over Zhai (1996)
The Examiner finds that Zhai (1996) teaches “immunizing mice with
a DNA construct encoding a xenogeneic (human) polypeptide designated
‘gp100’” and that “immunization led to the induction of an anti-tumor
cellular immune response in the mice and protected the mice from
intradermal tumor challenge” (Ans. 62). The Examiner finds that “vector
described by the prior art is not truly an adenovirus, but is actually a
replication-deficient recombinant version of a virus particle into which
exogenous (foreign) DNA encoding the gp100 antigen has been inserted”
(Ans. 63).
Appellants contend that Zhai (1996) teaches vaccines that “are in the
form of recombinant adenovirus vectors containing MARTI or gp100
DNA. . . . There is no disclosure of any other vector” (Br. 9). Appellants
contend that the “Examiner has not offered any reasoning how this could
ever fall within the scope of a claim requiring the use of a non-viral plasmid
vector” (Br. 9).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s finding that Zhai (1996) teaches a “non-viral
plasmid vector” as required by claim 1?
Findings of Fact
9. Zhai (1996) teaches that to “generate the recombinant
adenovirus vectors . . . pAd2CMV-gp100 DNA and the PshA1-digested
wild-type Ad2 DNA were co-transfected into the adenovirus packaging cell
line 293 . . . . Viral plaques were isolated and expanded, then the
recombinant viruses were identified” (Zhai (1996) 701, col. 1).
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10. Zhai (1996) teaches that “[t]umor target cells were infected
with either Ad2CMV-MARTI or Ad2CMV-gp100 at a multiplicity of
infection (MOI) of 10” (Zhai (1996) 701, col. 2).
Principles of Law
“A rejection for anticipation under section 102 requires that each and
every limitation of the claimed invention be disclosed in a single prior art
reference.” In re Paulsen, 30 F.3d 1475, 1478–79 (Fed. Cir. 1994).
Analysis
We find that Appellants have the better position because the
immunization vectors administered in Zhai (1996) were infectious
recombinant adenoviruses that were formed by recombination of plasmid
vectors with adenoviral vectors (FF 9–10). The recombinant adenoviruses
used by Zhai (1996) for immunization are not reasonably interpreted as a
“non-viral plasmid vector” as require by claim 1. “The protocol of giving
claims their broadest reasonable interpretation during examination does not
include giving claims a legally incorrect interpretation.” In re Skvorecz, 580
F.3d 1262, 1267 (Fed. Cir. 2009).
Conclusion of Law
The evidence of record does not support the Examiner’s finding that
Zhai (1996) teaches a “non-viral plasmid vector” as required by claim 1.

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E. 35 U.S.C. § 103(a) over Zhai (1996) and Zhai (1997)
The Examiner finds it obvious “to have immunized a human subject
using a DNA construct encoding a xenogeneic ‘gp100’ . . . in order to
enhance the immunologic response in patients (humans) to their own
tumors” (Ans. 66).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s finding that Zhai (1996) and Zhai (1997)
render obvious a “non-viral plasmid vector” as required by claim 1?
Findings of Fact
11. Zhai (1997) teaches that “mice were immunized intravenously
with 109 plaque-forming units (PFU) of recombinant adenoviruses encoding
. . . human gp100 . . . . Fourteen days later, immunized mice were boosted
with various recombinant adenoviruses (109 PFU) or vaccinia viruses (2 x
107 PFU) encoding human MART1/gp100” (Zhai (1997) 3).
Principles of Law
To establish a prima facie case of obviousness, the Examiner must
find “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).
Analysis
We find that Appellants have the better position because the
immunization vectors administered in Zhai (1996) and Zhai (1997) were
viruses, either adenoviruses or vaccinia viruses (FF 10–11). The Examiner
provides no evidence or persuasive reasoning in this rejection based on
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either Zhai (1996) or Zhai (1997) for immunization using “non-viral plasmid
vectors” as required by claim 1.
Conclusion of Law
The evidence of record does not support the Examiner’s finding that
Zhai (1996) and Zhai (1997) render obvious a “non-viral plasmid vector” as
required by claim 1.

F. 35 U.S.C. § 103(a) over Zhai (1996), Zhai (1997), and Zhou
The Examiner relies upon Zhou for this rejection, but we have already
determined that the instant claims receive benefit of priority to
PCT/US97/22669 filed on Dec. 10, 1997, two years prior to the publication
date of the Zhou reference. Therefore, Zhou is not prior art to the instant
claims. We therefore reverse this rejection.

G. 35 U.S.C. § 103(a) over Zhai (1996), Zhai (1997), and Sundaram
The Examiner finds that “neither Zhai et al. (1996) nor Zhai et al.
(1997) suggest that immunization is achieved by immunization with gold
particles coated with DNA” (Ans. 79). The Examiner finds it obvious to
“have immunized the subject by the process of gold particle-mediated
delivery of recombinant expression vectors encoding the xenogeneic
antigen, as taught by Sundaram” (Ans. 79).
Appellants contend that the Zhai references show
a single instance of successful immunotherapy with a
xenogeneic antigen, and that was in the human gp100 in an
adenoviral vector. Zhai et al (1997) also discloses a
different viral vector (vaccinia) with human gp100 and
indicates that this is not useful for stimulating an immune
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response. Against this backdrop, the reasonable conclusion
is that there is something special and necessary about
adenovirus, and it would not have been obvious or suggested
to discard this component of the working system and use a
non-viral plasmid vector, and that doing so would have no
expectation of success based on the teachings of the art.

(Br. 11).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s finding that Zhai (1996), Zhai (1997), and
Sundaram render claims 1 and 6 obvious?
Findings of Fact
12. Zhai (1997) teaches that:
To develop a syngeneic animal model for evaluating
antigen-specific vaccines in cancer therapy, the murine
homologues of the human melanoma antigens MART1 and
gp 100, which were specifically recognized by tumor-
infiltrating lymphocytes from patients with melanoma, were
cloned . . . . Mice immunized with murine MART1 or gp
100 using recombinant vaccinia virus failed to produce any
detectable T-cell responses or protective immunity against
B16 melanoma. In contrast, immunization of mice with
human gp 100 using recombinant adenoviruses elicited T
cells specific for hgp100

(Zhai 1997 1, abstract).
13. Zhai (1997) teaches that “immunization with heterologous
tumor antigen, rather than self, may be more effective as an
immunotherapeutic reagent in designing antigen-specific cancer vaccines”
(Zhai (1997) 1, abstract).
14. Sundaram teaches that “[p]olyclonal antibodies were generated
in rabbits by delivery to skin of gold particles coated with mammalian
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expression vectors encoding a cytoplasmic (-galactosidase) or a nuclear
(L1 capsid of cottontail rabbit papillomavirus) protein. One primary and one
booster immunization of 30 g DNA per rabbit yielded specific antisera”
(Sundaram 1375, abstract).
15. Sundaram teaches that “[g]enetic immunization requires
relatively small amounts of DNA, eliminates the need to purify the protein
immunogen, and does not require irritating adjuvants” (Sundaram 1375,
abstract).
16. Sundaram teaches that “[t]hese results strongly imply that the
method will be applicable to a broad array of genes” (Sundaram 1377, col.
1).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR, 550 U.S. at 416.
Analysis
We find that the Examiner has the better position. Zhai (1997)
teaches a method for stimulating an immune response by administering a
heterologous, non-self, antigen (FF 13), specifically teaching the
administration of a xenogeneic gp100 to stimulate an immune response with
a vector that comprises the melanosomal gp100 antigen under the control of
an expression promoter (FF 12). Sundaram teaches an alternative approach
for stimulating an immune response by genetic immunization using non-
viral plasmid vectors and gold particles (FF 14–15).
Applying the KSR standard of obviousness to the findings of fact, we
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conclude that the person of ordinary creativity would have predictably
substituted Sundaram’s genetic immunization approach using non-viral
plasmid vectors for the viral vectors of Zhai (1997) because Sundaram
teaches that the genetic immunization “method will be applicable to a broad
array of genes” (FF 16). Moreover, Sundaram establishes that the genetic
immunization method was a known equivalent to the viral immunization
method of Zhai (1997) at the time of invention. Therefore, such a
combination is merely a “predictable use of prior art elements according to
their established functions.” KSR, 550 U.S. at 417.
We recognize, but are not persuaded by, Appellants’ argument that
“there is something special and necessary about adenovirus, and it would not
have been obvious or suggested to discard this component of the working
system and use a non-viral plasmid vector, and that doing so would have no
expectation of success based on the teachings of the art” (Br. 11).
In this case, Zhai (1997) directs the ordinary artisan to treat tumors by
vaccination with xenogeneic gp100 (FF 12–13) while Sundaram teaches the
efficacy of vaccination using plasmids and gold particles, noting that “the
method will be applicable to a broad array of genes” (FF 14–16). Thus, the
prior art provides specific indication of critical parameters and specific
guidance on how to achieve success. “‘Obviousness does not require
absolute predictability of success . . . all that is required is a reasonable
expectation of success.’” In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009)
Here, the combination of Zhai (1997) and Sundaram provide a reasonable
expectation of success in stimulating an immune response to gp100 by
immunization with gold particles comprising a non-viral plasmid vector (FF
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12–16).
Conclusion of Law
The evidence of record supports the Examiner’s finding that Zhai
(1996), Zhai (1997), and Sundaram render claims 1 and 6 obvious.

H. Double Patenting
We note that Appellants dictated the rate of prosecution through the
office, filing the application that matured into the ’805 patent on Nov. 27,
2001, a patent that issued on July 7, 2009, while the instant application was
not filed until November 19, 2009, after the issuance of the ’805 patent and
substantially after the filing date of the ’805 patent. Thus, the one-way test
was reasonably applied by the Examiner, and we agree with the finding that
“the claimed subject matter of the patent anticipates the claimed subject
matter of the instant application and any minor differences in the subject
matter claimed in the instant application would be seen as an obvious
variation of the subject matter claimed in the patent” (Ans. 83).
Appellants do not make any substantive arguments regarding the
double patenting rejection over the ’805 patent, arguing instead that “the
only question here is whether there is an [sic] valid basis for refusing grant
of this patent because the second statement of the terminal disclaimer
requiring common ownership cannot be made” (Br. 12). Specifically,
Appellants specify that the instant “application is assigned to Sloan-
Kettering Institute for Cancer Researc (SKI) [sic], while the ‘805 patent is
jointly assigned to SKI and the Animal Medical Center” (id.).
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We find this argument unpersuasive because “harassment justification
for obviousness-type double patenting is particularly pertinent here because
the . . . application and the . . . patents are not commonly owned. If the . . .
application and the . . . patents were commonly owned, the terminal
disclaimer filed in this case would have been effective to overcome the
double patenting rejection.” In re Fallaux, 564 F.3d 1313, 1318 (Fed. Cir.
2009). We note that this defect was of Appellants creation as through
assignment it allowed ownership of the applications to be divided among
different entities, because the original assignment received on May 7, 2003
was to the Sloan-Kettering Institute for Cancer Research and it was only in
the later July 23, 2003 assignment that The Animal Medical Center was
added to the assignment.
SUMMARY
We reverse the rejection of claims 1–3, 5, 6, 8–10, 14, and 15 under
35 U.S.C. § 112, second paragraph as being indefinite.
We reverse the rejection of claims 1–3, 5, 6, 8–10, 14, and 15 under
35 U.S.C. § 112, first paragraph as failing to comply with the written
description requirement.
We reverse the rejection of claims 1, 8–10, and 15 as anticipated
under 35 U.S.C. § 102(b) by Zhai (1996).
We reverse the rejection of claims 1–3 and 14 under 35 U.S.C.
§ 103(a) as obvious over Zhai (1996) and Zhai (1997).
We reverse the rejection of claims 1 and 5 under 35 U.S.C. § 103(a)
as obvious over Zhai (1996), Zhai (1997) and Zhou.
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We affirm the rejection of claims 1 and 6 under 35 U.S.C. § 103(a) as
obvious over Zhai (1996), Zhai (1997) and Sundaram.
We affirm the rejection of claim 1, 5, 6, and 8–10 under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1–10 of U.S. Patent No. 7,556,805.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).

AFFIRMED-IN-PART