10304059 (B.P.A.I. Dec. 7, 2010)

Ex Parte Gromeier et al

Board of Patent Appeals and InterferencesDec 7, 2010

10304059 (B.P.A.I. Dec. 7, 2010)

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. 10/304,059 11/26/2002 Matthias Gromeier 1579-769 4512 23117 7590 12/07/2010 NIXON & VANDERHYE, PC 901 NORTH GLEBE ROAD, 11TH FLOOR ARLINGTON, VA 22203 EXAMINER KELLY, ROBERT M ART UNIT PAPER NUMBER 1633 MAIL DATE DELIVERY MODE 12/07/2010 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte MATTHIAS GROMEIER and ELENA Y. DOBRIKOVA __________ Appeal 2010-009648 Application 10/304,059 Technology Center 1600 __________ Before DONALD E. ADAMS, FRANCISCO C. PRATS, and JEFFREY N. FREDMAN, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal under 35 U.S.C. § 134 involves claims to an expression vector. The Examiner rejected the claims as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2010-009648 Application 10/304,059 2 STATEMENT OF THE CASE Claims 1, 4, 12, and 16-22 stand finally rejected and are on appeal (App. Br. 5). Claim 1 is representative and reads as follows: 1. An expression vector comprising an Enterovirus a portion of an internal ribosomal entry site (IRES) of which is replaced by a heterologous sequence encoding a protein, wherein said heterologous sequence encoding said protein replaces stem loop domain VI of said IRES and has the secondary structure, and thereby the function, of said replaced stem loop domain VI of said IRES, and wherein said heterologous sequence encoding said protein is up to 300 nucleotides in length. The following rejections are before us for review: (1) Claims 1, 4, 12, 16-18, and 20-22, rejected under 35 U.S.C. § 102(b) as anticipated by Graff2 (Final Rejection 2-4 (entered June 26, 2009)); and (2) Claim 19, rejected under 35 U.S.C. § 103(a) as obvious over Graff and Andino3 (Final Rejection 7 (entered June 26, 2009)). ANTICIPATION ISSUE The Examiner cites Graff as disclosing poliovirus (PV) vectors that include heterologous hepatitis A virus (HAV) sequences, the heterologous sequences having the features required in claim 1 (Ans. 4-5). Appellants argue that the heterologous sequences in Graff’s constructs do not have the 2 Judith Graff and Ellie Ehrenfeld, Coding Sequences Enhance Internal Initiation of Translation by Hepatitis A Virus RNA In Vitro, 72 J. VIROL. 3571-77 (May 1998). 3 Raul Andino et al., Engineering Poliovirus as a Vaccine Vector for the Expression of Diverse Antigens, 265 SCIENCE 1448-1451 (1994). Appeal 2010-009648 Application 10/304,059 3 features required by claim 1 because the “inserted coding region in Graff et al (a portion of the HAV open reading frame (ORF)) does not replace IRES structure (nor does it mimic secondary structure elements of the 5'UTR [untranslated region])” (App. Br. 11). The Examiner responds that the “broadest reasonable interpretation [of the claims] is that the protein-encoding sequence does not have to co- exist in the same region of the nucleic acid [as the stem loop domain VI-replacing region], but may be in the same nucleic acid, in different regions” (Ans. 7). Appellants urge that “[b]asis for this comment is not seen,” given the current claim language (App. Br. 12). Appellants do not argue the claims subject to this ground of rejection separately. We select claim 1 as representative of the rejected claims. See 37 C.F.R. § 41.37(c)(1)(vii). In view of the positions advanced by Appellants and the Examiner, the issue with respect to this rejection is whether the constructs described by Graff are encompassed by claim 1, when that claim is given its broadest reasonable interpretation consistent with the Specification. FINDINGS OF FACT (“FF”) Specification 1. The Specification discloses a “strategy for designing genetically stable viral expression vectors suitable for use in immunization and gene therapy regimens” (Spec. 14). 2. The Specification discloses: In accordance with this strategy, a virus is coerced into retaining foreign (heterologous) inserted genetic material by replacing a regulatory secondary structure of the virus with a foreign encoding sequence having a comparable structure. The Appeal 2010-009648 Application 10/304,059 4 present strategy thus results in the creation of sequences that serve two functions: they exerted regulatory influences (due to secondary structure) and they encode a desired gene product. (Id. at 14-15; see also, e.g., Figures 2A-2C (showing insertion of rhinovirus coding sequences in place of stem loop domain VI of Enterovirus IRES).) Graff 3. Graff investigated “the efficiency of HAV IRES utilization in a series of chimeric RNAs between HAV and PV sequences, translated in HeLa cell extracts” (Graff 3571). Graff found that “sequences downstream of the HAV 5'NCR [non-coding region] extending into the capsid coding sequence of HAV have a significant impact on translation efficiency directed by the HAV IRES in vitro” (id.). 4. Among Graff’s chimeric RNA constructs were “HAV/PV chimeric plasmids containing the truncated PV P1 capsid coding region fused in frame to different lengths of HAV coding sequences downstream of the HAV 5'NCR” (id. at 3572). 5. Graff’s heterologous sequences thus contained protein-encoding segments (id. (see Fig. 1 (“Striped boxes represent HAV coding sequences”))). 6. With respect to the non-coding portion of the heterologous sequence, Graff “replac[ed] the PV IRES with the HAV IRES and maintain[ed] the 5'- terminal 109 nt of the PV 5'NCR” (id.). PRINCIPLES OF LAW “To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Appeal 2010-009648 Application 10/304,059 5 During examination, the PTO must interpret terms in a claim using “the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). However, “[a]bsent claim language carrying a narrow meaning, the PTO should only limit the claim based on the specification . . . when [it] expressly disclaim[s] the broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed Cir. 2004); see also Sjolund v. Musland, 847 F.2d 1573, 1581 (Fed. Cir. 1988) (“[W]hile it is true that claims are to be interpreted in light of the specification and with a view to ascertaining the invention, it does not follow that limitations from the specification may be read into the claims.”). Thus, “during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.” In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989). ANALYSIS The outcome in this case turns on claim interpretation. Appellants’ arguments do not persuade us that, when its given its broadest reasonable interpretation, claim 1 fails to encompass the construct described by Graff. It is undisputed that, as claim 1 requires, Graff discloses an expression vector in which a portion of an internal ribosomal entry site (IRES) of an Enterovirus, poliovirus (PV) specifically, was replaced by a heterologous sequence (FF 6). It is undisputed that, as claim 1 also requires, the heterologous sequence obtained from hepatitis A virus (HAV) included an open reading frame and thus encoded a protein (FF 4, 5). Appellants also do Appeal 2010-009648 Application 10/304,059 6 not dispute that Graff’s construct meets claim 1’s nucleotide length requirement (see App. Br. 9-13). Regarding its construct, Graff discloses that, upstream of the open reading frame, the HAV heterologous sequence also contained its own IRES (FF 6), which Appellants concede “functionally replaces the intact PV IRES demonstrating equivalent function of picornavirus IRES elements” (App. Br. 11). Thus, as claim 1 requires, the heterologous sequence portion of Graff’s construct encoded a protein, and also contained sequences that formed stem loop structures that functionally replaced stem loop domain VI of the Enterovirus. Appellants urge that it is unreasonable to interpret claim 1 as encompassing constructs like Graff’s, in which non-protein-coding portions of the heterologous sequence form the stem loop structure that functionally replaces domain VI of the Enterovirus IRES (see App. Br. 12). We do not agree. As noted above, “during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.” In re Zletz, 893 F.2d at 322. In the instant case, we are not persuaded that Appellants have adequately distinguished their claims from Graff. In particular, claim 1 does not contain any specific limitation that excludes non-protein-coding sequences from satisfying the inserted heterologous sequence requirement, nor does claim 1 exclude non-protein- coding sequences from replacing stem loop VI. Claim 1 also does not contain any specific limitation that requires a protein-coding portion of the heterologous sequence to functionally replace stem loop VI. Appeal 2010-009648 Application 10/304,059 7 We acknowledge that Appellants’ Specification describes embodiments in which the protein-coding portion of the heterologous sequence forms the required stem loop structure (FF 1, 2). However, as noted above, it is improper to read limitations or preferred embodiments into the claims from the Specification. In re Bigio, 381 F.3d at 1325; Sjolund v. Musland, 847 F.2d at 1581. In sum, because the heterologous sequence portion of Graff’s construct encoded a protein, and also contained sequences that formed stem loop structures which functionally replaced stem loop domain VI of the host Enterovirus sequences, Appellants’ arguments do not persuade us that Graff fails to meet all of the limitations of claim 1. Accordingly, we affirm the Examiner’s rejection of claim 1 over Graff. As they were not argued separately, claims 4, 12, 16-18, and 20-22 fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(vii). OBVIOUSNESS The Examiner rejected claim 19 as obvious over Graff and Andino, concluding that an ordinary artisan would have considered it obvious in view of Andino to administer Graff’s polioviruses as vaccines (see Ans. 6). Appellants do not argue that an ordinary artisan would have failed to combine the references in the manner posited by the Examiner, but instead argue only that Andino fails to remedy Graff’s shortcomings with respect to claim 1 (App. Br 13). For the reasons discussed above, we are not persuaded that Graff fails to teach a vector having a heterologous sequence encompassed by claim 1. Accordingly, we affirm the Examiner’s obviousness rejection of claim 19, which depends ultimately from claim 1. Appeal 2010-009648 Application 10/304,059 8 SUMMARY We affirm the Examiner’s rejection of claims 1, 4, 12, 16-18, and 20- 22 under 35 U.S.C. § 102(b) as anticipated by Graff. We also affirm the Examiner’s rejection of claim 19 under 35 U.S.C. § 103(a) as obvious over Graff and Andino. TIME PERIOD 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 alw NIXON & VANDERHYE, PC 901 NORTH GLEBE ROAD, 11TH FLOOR ARLINGTON, VA 22203