Ex Parte Von Der Mulbe et al

Patent Trial and Appeal Board

Jun 21, 2018

10729830 (P.T.A.B. Jun. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
101729,830 12/05/2003
108197 7590 06/25/2018
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
Austin, TX 78746
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Florian Von Der Mulbe
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
CRV C.P0003US 8653
EXAMINER
DUNSTON, JENNIFER ANN
ART UNIT PAPER NUMBER
1636
NOTIFICATION DATE DELIVERY MODE
06/25/2018 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
docket@phiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FLORIAN VON DER MULBE, INGMAR HOERR, and
STEVE PASCOL0 1
Appeal 2016-005808
Application 10/729,830
Technology Center 1600
Before DEBORAH KATZ, JOHN E. SCHNEIDER, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
mRNA pharmaceutical composition which have been rejected as directed to
as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
STATEMENT OF THE CASE
"Conventional procedures involved in previous applications of gene
therapy and genetic vaccination involved the use of DNA in order to
1 Appellants identify the Real Party in Interest as CureVac AG. Appeal Br.
3.
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Application 10/729,830
incorporate the required genetic information into a cell." Spec. i-f 4. Use of
DNA poses several safety risks including producing a mutation that
interferes with the function of the endogenous gene, as well as the induction
of pathogenic anti-DNA antibodies in the patient. Spec. i-fi-1 6-7. "In contrast
to DNA, the use of RNA as a therapeutic agent or vaccine is regarded as
significantly safer." Spec. i-f 8.
The Specification describes a system for gene therapy and genetic
vaccination that overcomes the disadvantages of DNA therapeutic agents
and DNA vaccines and increase the effectiveness of therapeutic agents based
on RNA species.
Claims 32-37, 39, 40, 43-54, 57, 58, 60, 61, 64, 67, 70, and 71 are on
appeal. Claim 32 is representative and reads as follows:
32. A cell-free mRNA pharmaceutical composition
comprising at least one modified mRNA and a
pharmaceutically compatible carrier, wherein the modified
mRNA encodes at least one human tumour-specific antigenic
polypeptide capable of stimulating an immune response in a
patient against the human tumour-specific antigenic
polypeptide wherein said modified mRNA encoding the human
tumour-specific antigenic polypeptide has been stabilized by
increasing its Guano sine/ Cytosine ( G/C) content by at least 7
percentage points relative to that of the wild-type mRNA
encoding the tumour-specific antigenic polypeptide.
The claims have been rejected as follows:
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Application 10/729,830
Claims 32-37, 43, 44, 46, 50, 52, 57, 58, and 61 have been rejected
under 35 U.S.C. § 103(a) as unpatentable over Felgner2 in view of Neeper, 3
GenBank, 4 and Fujimoto. 5
Claims 45, 47--49, 51, 54, and 70 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Felgner in view of Neeper, GenBank, and
Fujimoto in further view of Scholler. 6
Claim 53 has been rejected under 35 U.S.C. § 103(a) as unpatentable
over Felgner in view of Neeper, GenBank, Fujimoto and Scholler in further
view of Hoerr. 7
Claims 32-37, 39, 40, 43, 44, 46, 50, 52, 57, 58, 60, 61, 64, 67, and 71
have been rejected under 35 U.S.C. § 103(a) as unpatentable over Felgner in
view of Eisenbach, 8 Zrihan-Licht, 9 Seldon, 10 and L6pez-F errer. 11
2 Felgner at al., US 5,580,859, issued Dec. 3, 1996 ("Felgner").
3 Neeper et al., WO 01/14416 A2, published Mar. 1, 2001 ("Neeper").
4 Genbank, Human papillomavirus type 16 isolate l 6Wl 2E, complete
genome, found at http://www.ncbi.nlm.nih.gov/nuccore/AF125673.l, last
accessed Oct. 6, 2015.
5 Fujimoto, EP 0175960 Al, published Apr. 2, 1986 ("Fujimoto").
6 Scholler et al., US 2003/0008342 Al, published Jan. 9, 2003 ("Scholler").
7 Hoerr at al., EP 1083232 Al, published Mar. 14, 2001 ("Hoerr").
8 Eisenbach et al., WO 00/06723, published Feb. 10, 2000 ("Eisenbach").
9 Zrihan-Licht et al., Characterization and molecular cloning of a novel
MUCJ protein, devoid of tandem repeats, expressed in human breast cancer
tissue, 224 Eur. J. Biochem. 787 ("Zrihan-Licht").
10 Seldon et al., WO 02/064799 A2, published Aug. 22, 2002 ("Seldon").
11 Lopez-Ferrer et al., Mucins as Differentiation Markers in Bronchial
Epithelium Squamous Cell Carcinoma and Adenocarcinoma Display Similar
Expression Patterns, 24 Am. J. Respir. Cell Mol. Biol. 22 (2001) ("L6pez-
Ferrer").
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Application 10/729,830
Claims 45, 47--49, 51, 54, and 70 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Felgner in view of Eisenbach, Zrihan-Licht,
Seldon, and Lopez-Ferrer, in further view of Scholler.
Claim 53 has been rejected under 35 U.S.C. § 103(a) as unpatentable
over Felgner in view of Eisenbach, Zrihan-Licht, and Seldon in further view
of Scholler and Hoerr.
Principles of Law
In proceedings before the Patent and Trademark Office,
the Examiner bears the burden of establishing a prima facie
case of obviousness based upon the prior art. '[The Examiner]
can satisfy this burden only by showing some objective
teaching in the prior art or that knowledge generally available to
one of ordinary skill in the art would lead that individual to
combine the relevant teachings of the references.' The patent
applicant may then attack the Examiner's prima facie
determination as improperly made out, or the applicant may
present objective evidence tending to support a conclusion of
nonobviousness.
In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992) (citations omitted).
DISCUSSION
Rejections based on Feigner combined with Neeper
Issue
The first set of rejections all rely on the combined teachings of
Felgner and Neeper. Because the same issue is dispositive for all these
claims, we shall treat them together. The issue with respect to these
rejections is whether the Examiner has shown a proper motivation to
combine the teachings of Felgner and Neeper.
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Application 10/729,830
The Examiner finds that Felgner teaches a pharmaceutical
composition comprising a modified mRNA. Final Act. 7. The Examiner
acknowledges that Felgner does not teach a composition where the modified
mRNA encodes for a human tumor antigen nor does Felgner disclose an
mRNA which has been stabilized by increasing the GC content relative to
the wild-type mRNA. Id. at 7-8. To remedy this deficiency, the Examiner
turns to Neeper.
The Examiner finds that Neeper discloses nucleic acid based vaccines
against papillomavirus (HPV) which have been codon optimized for
expression in a human cell environment. Final Act. 8. The Examiner finds
that the codon optimization of Neeper results in increasing the GC content of
the polynucleotide encoding for the HPV relative to the wild-type sequence.
The Examiner concludes:
It would have been obvious to one of ordinary skill in
the art at the time the invention was made to modify the
composition containing a modified mRNA encoding a tumor
antigen of Felgner et al to include mRNA(s) transcribed from
the HPV 16 or 18 sequences taught by Neeper et al, because
Felgner et al teach it is within the ordinary skill in the art to use
mRNA encoding a tumor antigen, and Neeper et al teach that
protein genes from HPV 16 and 18 are tumor antigens for
highly invasive genital and anal carcinomas.
One would have been motivated to make such a
modification in order to receive the expected benefit of
providing mRNA encoding tumor antigens for a specific type of
cancer as taught by Neeper et al. Furthermore, one would have
made such a modification to provide mRNA with maximum
G/C content due to the replacement of rare codons with
common codons of highly expressed genes (codons recognized
by abundant cellular tRNA), which would allow for improved
expression of the HPV antigens. Based upon the teachings of
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Application 10/729,830
the cited references, the high skill of one of ordinary skill in the
art, and absent any evidence to the contrary, there would have
been a reasonable expectation of success to result in the claimed
invention.
Final Act. 9.
Appellants contend that none of the references teach or suggest
increasing GC content of a polynucleotide. Appeal Br. 5. Appellants argue
that the codon optimization taught by Neeper does not inherently increase
the GC content of the resulting polynucleotide. Id. Appellants also argue
that one skilled in the art would not apply the codon optimization of Neeper
to a polynucleotide encoding for a human tumor antigen because one skilled
in the art would not expect the polynucleotide to require such optimization.
Reply Br. 3.
Analysis
On the record before us we find that the Examiner has not established
a prima facie case of obviousness. We agree with Appellants that the
Examiner has failed to establish why one skilled in the art would employ
codon optimization on an mRNA sequence which encodes for a human
tumor antigen.
While we agree with the Examiner that Neeper teaches codon
optimization that results in increased GC content for a polynucleotide
encoding for a HPV antigen, the HPV antigen is not a human tumor antigen.
See, Neeper 1. Codon optimization is done to improve the performance of
the HPV antigen in a human or mammal system. Neeper 7, Ans. 3--4.
Appellants' claims, however, are directed to a human tumor antigen, not a
viral antigen. See claim 32 above. We agree with Appellants on this record
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Application 10/729,830
that one skilled in the art would see no need to optimize a polynucleotide
encoding for a human tumor antigen to allow for expression in a human.
Reply Br. 3. The Examiner has pointed to nothing in the record to show
why one skilled in the art would seek to optimize a polynucleotide encoding
for a human tumor antigen.
We reverse the rejections based on the combination of Felgner and
Neeper.
F elgner combined with Eisenbach, Zrihan-Licht, and Seldon
Here again the rejections all rely on the same combination and present
the same issue - whether the Examiner has shown a proper motivation to
combined the teachings of Felgner with Eisenbach, Zrihan-Licht and Seldon.
Therefore, we shall treat the rejections together.
As with the rejection based on Felgner, and Neeper, the Examiner
contends that one skilled in the art would use codon optimization as taught
by Seldon to increase the GC content of a polynucleotide encoding for an
antigen. Final Act. 13-14. In this rejection, the polynucleotide encodes for
MUC 1 peptides specifically human peptides. Final Act. 15.
Here again, we find that the Examiner has not shown why one skilled
in the art would optimize the polynucleotide encoding for the human tumor
antigen MUC 1. While we agree with the Examiner that the codon
optimization taught by Seldon would lead one skilled in the art to increase
GC content to improve performance in the human environment, see Ans. 8,
the Examiner has not pointed to any evidence in the record to show why one
skilled in the art would apply codon optimization to a human tumor antigen
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that already works (and is presumably already optimized) in a human
environment.
We reverse the rejections based on Felgner, Eisenbach, Zrihan-Licht,
and Seldon.
SUMMARY
We reverse the rejections under 35 U.S.C. § 103(a).
REVERSED
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