CureVac AG

Patent Trials and Appeals Board

Jan 12, 2021

2020004253 (P.T.A.B. Jan. 12, 2021)

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.
15/835,403 12/07/2017 Ingmar Hoerr CRVC.P0025US.C1 1063
174917 7590 01/12/2021
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
Austin, TX 78746
EXAMINER
LONG, SCOTT
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
01/12/2021 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 INGMAR HOERR and STEVE PASCOLO
Appeal 2020-004253
Application 15/835,403
Technology Center 1600
Before ERIC B. GRIMES, JOHN E. SCHNEIDER, and
MICHAEL A. VALEK, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 22–41. See Final Act. 1. We have
jurisdiction under 35 U.S.C. § 6(b).
We Affirm.2

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as CureVac AG. Appeal
Br. 3.
2 An oral hearing was held on January 7, 2021. A transcript of the hearing
will be made of record.
Appeal 2020-004253
Application 15/835,403
2
CLAIMED SUBJECT MATTER
The claims are directed to an injection solution for mRNA. Claim 22,
reproduced below, is illustrative of the claimed subject matter:
22. A method for increasing the expression of a selected antigen
in an organism comprising:
a) obtaining an aqueous mRNA injection solution
comprising a calcium salt and a purified mRNA encoding the
selected antigen, wherein said mRNA is capped and comprises a
poly-A tail; and
b) injecting the aqueous mRNA injection solution into an
organism intradermally or intranodally, thereby expressing the
selected antigen in the organism.
Appeal 2020-004253
Application 15/835,403
3
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Herweijer, Hans US 2002/0165183 A1 Nov. 7, 2002
Hoerr, Ingmar Hoerr et al., In vivo
application of RNA
leads to induction of
specific cytotoxic T
lymphocytes and
antibodies, 30 Eur. J.
Immunol. 1 (2000)
2000
Zrihan-Licht, Sheila Zrihan-Licht et al.,
Characterization and
molecular cloning of a
novel MUC1 protein,
devoid of tandem
repeats, expressed in
human breast cancer
tissue, 224 Eur. J.
Biochem. 787 (1994)
1994
Norman, J. Norman et al.,
Liposome-mediated,
nonviral gene transfer
induces a systemic
inflammatory response
which can exacerbate
pre-
existing inflammation, 7
Gene Therapy 1425
(2000)
2000
White, S.A. White & Goldhill, Is
Hartmann’s the
solution?, 52 Anesthesia
422 (1997)
1997

Appeal 2020-004253
Application 15/835,403
4
REJECTIONS
Claims 22–25, 29–35, and 37–41 are rejected under pre-AIA 35
U.S.C. § 103(a) as being unpatentable over Herweijer in view of Hoerr.
Claim 35 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Herweijer in view of Hoerr as applied to claim 22 and 34
above, and further in view of Zrihan-Licht.
Claims 26–28 and 36 are rejected under pre-AIA 35 U.S.C. § 103(a)
as being unpatentable over Herweijer in view of Hoerr as applied to claim 22
above, and further in view of Norman as evidenced by White.
OPINION
This application is a continuation of application 11/914,945, which
was the subject of a previous appeal before us. In our prior decision, we
affirmed the Examiner’s rejection of similar claims over some of the same
art as listed above. In re Hoerr¸ Appeal 2016-001745, 1–2 (PTAB Oct. 18,
2017). In addition to finding that the pending claims were obvious over the
cited references, we found Appellant’s evidence of unexpected results to be
unpersuasive. Id. at 7–8. We found that there was no evidence in the record
that the results reported in the Specification were in fact unexpected nor did
the data reflect a comparison with the closest prior art. Id.
During prosecution of this continuation following the first appeal,
Appellant submitted the Declaration of Dr. Thomas Schlake3 to support
Appellant’s contention that there is sufficient evidence of unexpected results
to overcome a prima facie case of obviousness. Amendment and Response
to Office Action Mailed November 20, 2018, 5–10.

3 Declaration Under 37 C.F.R. § 1.132, filed May 20, 2019. (Schlake Decl.)
Appeal 2020-004253
Application 15/835,403
5
The Examiner considered Appellant’s argument and the Declaration,
but was not persuaded that the claimed invention was patentable. Final Act.
3–4. This appeal followed.
It its Appeal Brief, Appellant generally contends that the references
do not teach all the elements of the claims. Appeal Br. 4. Appellant does not
offer any substantive arguments or evidence to support this contention. Id.
We therefore conclude that the Examiner has set for a prima facie case of
obviousness as stated in the Final Action. Final Act. 4–16.
Appellant also contends that the record now contains evidence of
unexpected results sufficient to overcome the Examiner’s prima facie case of
obviousness. Appeal Br. 4. In support of this contention Appellant points to
the comparative data reported in the Specification and the Declaration of Dr.
Schlake where he reviews the data and opines that the results are surprising
and unexpected. Appeal Br. 4–9; Schlake Decl. ¶ 3.
In the Answer, the Examiner maintains the position that the alleged
unexpected results are insufficient to show non-obviousness. Ans. 5.
Specifically, the Examiner contends that the data reported does not contain a
comparison of the present invention with the closest prior art. Id. The
Examiner contends that the observed effect reported in the Specification
would have been present from the combination when the teachings of the
references were combined. Id. at 6–7. The Examiner contends that the data
in the Specification only compares the claimed calcium containing solution
with solutions without calcium whereas the art teaches the use of calcium
containing solutions. Id. at 7–8. Thus, the reported experiments do not
compare the claimed invention with the closest prior art. Id.
Appeal 2020-004253
Application 15/835,403
6
On its face, the Declaration of Dr. Schlake appears to support
Appellant’s contention that there is sufficient evidence of unexpected results
to overcome the Examiner’s rejection. Dr. Schlake analyzes the data
presented in the Specification comparing the claimed invention with
solutions found in the closest prior art. Schlake Decl. ¶¶ 3–4. Dr. Schlake
opines that the results achieved by the present invention are surprising and
unexpected. Id. Dr. Schlake also discusses the work reported by others
which supports his conclusion that the results achieved by the present
invention are surprising and unexpected. Id. ¶ 4.
The only issue that remains is succinctly summed up by Appellant,
“whether Dr. Schlake is qualified to make such as assessment.” Appeal Br.
11. On the record before us, the answer is no. While the Declaration lists the
declarant’s title as Dr. Schlake, Appellant does not point to nor do we
discern any evidence in the record showing Dr. Schlake’s qualifications. See
Schlake Decl. ¶ 1 and page 5. Without knowing Dr. Schlake’s qualifications
we do not give much weight to the Declaration. For this reason alone we
find that Appellant has not rebutted the Examiner’s prima facie case of
obviousness.
CONCLUSION
The Examiner’s rejections are affirmed.
More specifically,
The rejection of claims 22–25, 29–35, and 37–41 under pre-AIA 35
U.S.C. § 103(a) as being unpatentable over Herweijer in view of Hoerr is
affirmed.
Appeal 2020-004253
Application 15/835,403
7
The rejection of claim 35 under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Herweijer in view of Hoerr as applied to claim 22 and 34
above, and further in view of Zrihan-Licht is affirmed.
The rejection of claims 26–28 and 36 under pre-AIA 35 U.S.C.
§ 103(a) as being unpatentable over Herweijer in view of Hoerr as applied to
claim 22 above, and further in view of Norman as evidenced by White is
affirmed.
DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
22–25, 29–
35, 37–41
103(a) Herweijer, Hoerr 22–25, 29–
35, 37–41

35 103(a) Herweijer, Hoerr,
Zrihan-Licht
35
26–28, 36 103(a) Herweijer, Hoerr,
Norman, White
26–28, 36
Overall
Outcome
22–41

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