CureVac AG

Patent Trials and Appeals Board

Sep 10, 2021

2021000760 (P.T.A.B. Sep. 10, 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.
14/994,913 01/13/2016 Florian VON DER MÜLBE CRVC.P0003US.C4 8618
174917 7590 09/10/2021
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
Austin, TX 78746
EXAMINER
GILL, RACHEL B
ART UNIT PAPER NUMBER
1648
NOTIFICATION DATE DELIVERY MODE
09/10/2021 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 FLORAIN VON DER MÜLBE, INGMAR HOERR, and
STEVE PASCOLO
Appeal 2021-000760
Application 14/994,913
Technology Center 1600
Before JEFFREY N. FREDMAN, TAWEN CHANG, and
JOHN E. SCHNEIDER, 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 1, 3–5, 7–9, and 11–21. We have
jurisdiction under 35 U.S.C. § 6(b).2
We reverse.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as CurVac AG.
Appeal Br. 3.
2 An oral hearing was held on August 2, 2021. A copy of the transcript of the
hearing has been entered into the file.
Appeal 2021-000760
Application 14/994,913
2
CLAIMED SUBJECT MATTER
The claims are directed to a pharmaceutical composition containing
an mRNA that is stabilized by sequence modifications in the translated
region and is optimised for translation. Claim 1, reproduced below, is
illustrative of the claimed subject matter:
1. A method for stimulating an anti-influenza immune
response in a subject comprising administering an effective
amount to a subject of a pharmaceutical composition
comprising:
1) a mRNA that encodes an influenza virus antigen; and
2) an aqueous carrier,
wherein the mRNA lacks any promoter sequences,
wherein the mRNA comprises an increased G/C content of at
least 7% points relative to a wild-type mRNA encoding the
influenza virus antigen, wherein the influenza virus antigen
sequence encoded by the mRNA is unchanged compared to the
wild-type influenza virus antigen sequence, and wherein the
influenza virus antigen is an influenza virus surface antigen or
an influenza matrix protein.

The pending claims have been rejected under 35 U.S.C. § 112 as
failing to comply with the written description requirement.
OPINION
Issue
The issue on appeal is whether the Examiner has properly determined
that the claim contain subject matter that has not been described in the
specification to reasonably convey to one skilled in the relevant art that the
inventor, at the time the application was filed, had possession of the claimed
invention.
The Examiner finds that the claims are directed to an influenza
antigen broadly and that the Specification does not “convey applicant's
Appeal 2021-000760
Application 14/994,913
3
possession of the claimed genus of ‘an antigen’ from any of the listed
influenza polypeptides, especially in the claimed method of treatment for the
claimed function of eliciting an anti-influenza immune response.” Final Act.
4. The Examiner contends that the term antigen can include and refer to
protein fragments of an undefined length and that the written description is
limited to the entire protein matrix. Id. The Examiner also finds that the
Specification fails to provide any information as to how the mRNA is to be
delivered. Id. at 5.
Appellant contends that one skilled in the art would recognize the
Appellant was in possession of the invention as claimed at the time the
application was filed. Appeal Br. 4. Appellant contends that given such
factors as the existing knowledge in the particular field, the extent and
content of the prior art, the maturity of the science or technology, the
predictability of the aspect at issue, one skilled in the art would recognize
the invention defined by the claims. Id. at 5–6. Appellant contends the
Specification provides an example of a modified coding region of influenza
A altered according to the invention as well as an example and a computer
program that show how to modify any antigen of interest. Reply. Br. 4–5.
Appellant contends that given the general knowledge in the art and the
disclosure in the Specification, the written description requirement has been
met. Appeal Br. 6.
We have considered the arguments presented by the parties and the
evidence of record and find that Appellant has the better position.
The written description requirement is met if “the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date.”
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).
Appeal 2021-000760
Application 14/994,913
4
With particular regard to generic biological claims, the Federal Circuit has
held that
the determination of what is needed to support generic claims to
biological subject matter depends on a variety of factors, such as the
existing knowledge in the particular field, the extent and content of
the prior art, the maturity of the science or technology, the
predictability of the aspect at issue, and other considerations
appropriate to the subject matter.

Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).
As the Examiner acknowledges “[t]he art at the time of filing was
well-versed in various sequences from influenza viruses, including full-
length genomic sequences.” Ans. 6. Thus we agree with Appellant that there
was no requirement to disclose specific influenza genomic sequences.
Moreover, Appellant has shown that the method for increasing GC
content to improve stability is applicable to more than Influenza A. For
example, Appellant has demonstrated that the technique can be used to
optimize stability of a sequence of the lac-Z gene of E. coli and the tumor
antigen MAGE1. Spec. ¶¶ 90 and 94. Thus one skilled in the art would
appreciate that the stabilization method can be applied to a wide variety of
gene sequences including different influenza strains.
The Examiner contends that the term antigen, as used in the claims, is
not limited to whole protein but can include antigenic fragments. Ans. 8. The
Examiner contends that the Specification does not describe any antigenic
fragments that could be used in the practice of the claimed method. Id.
We are not persuaded by this argument. As Appellant points out, the
Specification discloses a method for identifying a “modified antigen coding
sequence for ANY antigen of interest such that it could be used according to
the methods.” Reply Br. 5. Moreover, the requirement that the GC content
Appeal 2021-000760
Application 14/994,913
5
be increased by 7% places a limit on what sequences can be used. Id. at 6. In
addition, there is a known lower limit to the size of encoded peptides that
will induce an immune response. Ans. 4–5.
Based on the foregoing, we find that the Examiner has not established
that the claims fail to comply with the written description requirement. The
rejection is therefore reversed.
CONCLUSION
The Examiner’s rejection of claims 1, 3–5, 7–9, and 11–21 under
35 U.S.C. § 112(a) for failure to comply with the written description
requirement is reversed.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3–5, 7–9,
11–21
112(a) Written
Description
1, 3–5, 7–9,
11–21

REVERSED