Ex Parte Ji et al

Patent Trial and Appeal Board

Aug 13, 2013

11372246 (P.T.A.B. Aug. 13, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte LIN X. JI, BINGLIANG FANG, and JACK A. ROTH
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Appeal 2012-000155
Application 11/372,246
Technology Center 1600
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Before DEMETRA J. MILLS, JOHN A. EVANS, and ULRIKE W. JENKS,
Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF CASE
21. A nucleic acid comprising a promoter region, the promoter region being
a mini-CMV promoter sequence operatively coupled to a tissue-selective
promoter sequence, wherein operatively coupling the tissue-selective
promoter sequence to the mini-CMV promoter sequence results in improved
promoter function of the tissue-selective promoter sequence.

23. A nucleic acid comprising a promoter sequence consisting essentially of
a mini-CMV promoter sequence operatively coupled to a tissue-selective
promoter sequence, wherein operatively coupling the tissue-selective
promoter sequence to the mini-CMV promoter sequence results in improved
promoter function of the tissue-selective promoter sequence.

Cited References

King et al., WO 96/39542, published December 12, 1996.

Promega, Biological Research Products, Catalogue 422-424 (1997).
Martinez-Salas, Internal ribosome entry site biology and its use in
expression vectors, 10 CURRENT OPINION IN BIOTECHNOLOGY 458-464
(1999).

Takakura, et al., Cloning of Human Telomerase Catalytic Subunit (hTERT)
Gene Promoter and Identification of Proximal Core Promoter Sequences
Essential For Transcriptional Activation in Immortalized and Cancer Cells,
59 CANCER RESEARCH 551-557 (1999).

Zinn et al., Gamma Camera Dual Imaging with a Somatostatin Receptor
and Thymidine Kinase after Gene Transfer with a Bicistronic Adenovirus,
223 RADIOLOGY 417-425 (2002).

Ito et al., Liposomal vector mediated delivery of the 3p FUS1 gene
demonstrates potent antitumor activity against human lung cancer in vivo,
11 CANCER GENE THERAPY 733-739 (2004).

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Grounds of Rejection
Claims 21, 23, 24, 26-28, 32-34, 44, 46, 49, 50, and 118-123 are
rejected under 35 U.S.C. § 103(a) as being unpatentable over King in view
of Takakura and Promega 1997 catalogue.
Claims 35-37, 56, and 57 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over King in view of Takakura and Promega 1997
catalogue, and further in view of Zinn.
Claims 29-31, 51, and 52 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over King in view of Takakura and Promega 1997
catalogue, and further in view of Ito.
Claims 38-43 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over King, Takakura and Promega 1997 catalogue, Zinn, Ito
and Martinez-Salas.1

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 4-
21.

Discussion
ISSUE
The Examiner concludes that

1 We note that in the Final Rejection and Answer, the Examiner failed to
recite King with respect to this rejection, which we believe to be error, as
claim 38 is dependent upon claim 34 which in turn depends upon claim 21,
which rejection includes King. We have treated this as a typographical error
and included King in the rejection.
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[I]t would have been prima facie obvious to one having
ordinary skill in the art at the time of the invention to combine
the teachings of King et al. regarding tetO/eCMV chimeric
promoter sequence which contains a prokaryotic tetracycline
operator (tetO) sequence fused to human cytomegalovirus early
promoter IE (eCMV), and the promoter is activated by the
tetR/VP16 chimeric transactivator protein, with the teachings of
Takakura et al., 1999 regarding cloning of human telomerase
catalytic subunit (hTERT) gene promoter and identification of
proximal core promoter sequences essential for transcriptional
activation in immortalized and cancer cells, and the teaching of
Promega 1997 catalog regarding BglII restriction enzyme site
and use the restriction enzymes for molecular cloning of a
nucleic acid sequence of interest, to arrive at claims 21, 23, 24,
26-28, 32-34, 44, 46, 49, 50, and 118-123 of instant application,
by substitution of tetracycline operator (tetO) taught by King et
al. with the hTERT promoter taught by Takakura et al. (1999).
One having ordinary skill in the art would have been
motivated to combine the teachings of King et al. Takakura et
al. and Promega 1997 catalog because to achieve tumor tissue
specificity, the tetO/eCMV chimeric promoter is not tumor
specific, and control of activation of tetO/eCMV chimeric
promoter relies on the presence or absence of tetracycline added
exogenously whereas the hTERT promoter is only expressed in
tumor cells by its intrinsic characteristics. Furthermore, King et
al. teaches mini-CMV (e-CMV) promoter can enhance the
promoter activity in the context of a fusion promoter. At
technical level for molecular cloning, Takakura et al. teaches
PCR-based protocol for construction of pGL3 plasmid from
Promega, which harboring a BglII site for cloning of hTERT
promoter.

(Ans. 12-13.)

Appellants argue that “King does not teach or suggest a mini-CMV
promoter. Rather, King teaches the use of a full-length eCMV promoter,
which is 432 nucleic acids in length and is NOT a mini-CMV promoter” and
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that “the Examiner has cited no art that teaches even a full-length CMV
promoter operably linked to a second promoter sequence.” (App. Br. 4.)
The dispositive issue with respect to each of the rejections is: Has the
Examiner provided evidence to support the conclusion that a “promoter
region being a mini-CMV promoter sequence operatively coupled to a
tissue-selective promoter sequence” was disclosed in the prior art?

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
As the Supreme Court pointed out in KSR Int' l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007), “a patent composed of several elements is
not proved obvious merely by demonstrating that each of its elements was,
independently, known in the prior art.” Rather, the Court stated:
[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 . . . because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
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discoveries almost of necessity will be combinations of what, in
some sense, is already known.

Id. at 418-419 (emphasis added); see also id. at 418 (requiring a
determination of “whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue”) (emphasis
added).
“‘It is impermissible within the framework of section 103 to pick and
choose from any one reference only so much of it as will support a given
position, to the exclusion of other parts necessary to the full appreciation of
what such reference fairly suggests to one of ordinary skill in the art.’” In re
Hedges, 783 F.2d 1038, 1041 (Fed. Cir. 1986) (quoting In re Wesslau, 353
F.2d 238, 241 (CCPA 1965)).
“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” KSR, 550 U.S 398, 418 (2007)(quoting In re Kahn, 441 F.3d
977, 988 (Fed. Cir. 2006).
Obviousness requires more than a mere showing that the prior art
includes separate references covering each separate limitation in a claim
under examination. KSR, 550 U.S. at 418. Rather, obviousness requires the
additional showing that a person of ordinary skill at the time of the invention
would have selected and combined those prior art elements in the normal
course of research and development to yield the claimed invention. Id. at
421. Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed.
Cir. 2011).
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The consistent criterion for determination of obviousness
is whether the prior art would have suggested to one of ordinary
skill in the art that this process should be carried out and would
have a reasonable likelihood of success, viewed in the light of
the prior art. Both the suggestion and the expectation of
success must be founded in the prior art, not in the applicant’s
disclosure.

In re Dow Chemical Co., 837 F.2d 469, 473 (Fed. Cir. 1988) (citations
omitted).
ANALYSIS
We do not find that the Examiner has provided evidence to support a
prima facie case of obviousness. In particular, we do not find that the
Examiner has provided evidence or a suggestion in the prior art of a mini-
CMV promoter linked to a tissue specific promoter. While we do agree that
the Examiner was able to find evidence that a truncated CMV promoter and
a tissue specific promoter, such as the hTERT promoter, were separately
known in the prior art, what is missing from the Examiner’s analysis is why
one of ordinary skill in the art would have combined them, in the manner
claimed to achieve improved promoter function of the tissue-selective
promoter sequence, as claimed. The Examiner argues that “King et al.
teaches mini-CMV (e-CMV) promoter can enhance the promoter activity in
the context of a fusion promoter” (Ans. 13), but provides no citation to King
or any other reference for this conclusory statement.
Obviousness requires more than a mere showing that the prior art
includes separate references covering each separate limitation in a claim
under examination. KSR, 550 U.S. at 418. Rather, obviousness requires the
additional showing that a person of ordinary skill at the time of the invention
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would have selected and combined those prior art elements in the normal
course of research and development to yield the claimed invention. Id. at
421. Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed.
Cir. 2011). We find no evidence on the record before us that a person of
ordinary skill at the time of the invention would have selected and combined
the prior art elements cited in the normal course of research and
development to yield the claimed invention. The obviousness rejections are
reversed.

CONCLUSION OF LAW
The cited references do not support the Examiner’s obviousness
rejections.

REVERSED

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