CureVac AGDownload PDFPatent Trials and Appeals BoardSep 10, 20212021000760 (P.T.A.B. Sep. 10, 2021) Copy Citation 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 Copy with citationCopy as parenthetical citation