DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Applicant’s amendment submitted 3/17/2026 is acknowledged. Claims 1, 5-6, 15-16, 22, 26-27, 29, 33-35, 51-52, 55-60, 108, and 112 are canceled. New claims 208-227 are added.
Claims 208-227 are under examination on the merits.
Withdrawn Objections
The previous objections are withdrawn due to Applicant’s amendment submitted on 3/17/2026:
Claim objections: claim 27 because of informalities.
Withdrawn Rejections
The previous rejections are withdrawn due to Applicant’s amendment submitted on 3/17/2026:
35 U.S.C. § 112(b): claims 1, 5-6, 15-16, 22, 26-27, 29, 33-35, 55, 57-60, 108, and 112
35 U.S.C. § 102: claims 1, 5, 29, 33, 55, 57-60, 108, and 112 under 35 U.S.C. 102(a)(1) as being anticipated by Zaza, et al. (Virol J. 2018 Jun 7;15(1):99. PMID: 29879985
35 U.S.C. §103: claim 22 under 35 U.S.C. 103 as being unpatentable over Zaza (supra), as applied to claims 1, 5, 29, 33, 55, 57-60, 108, and 112, and in further view of Laer, et al. (PGPub US 20080124308 A1, published 5/29/2008); claims 1, 5, 6, 15, 16, 26, 27, 29, 33-35, 55, 57-60, 108 and 112 under 35 U.S.C. 103 as being unpatentable over Belnoue, et al. (PGPub US20160024476 A1, priority date 3/15/2013, published 1/28/2016) in further view of Zaza, et al. (supra) and Schrempf, et al. (J Virol. 2007 Nov;81(22):12515-24. doi: 10.1128/JVI.01481-07. Epub 2007 Sep 5. PMID: 17804515). The previous rejections are withdrawn in favor of the new rejection under 35 U.S.C. §103 presented below.
Double Patenting: claims 1, 5, 6, 15, 16, 22, 26, 27, 29, 33-35, 55, 57-60, 108, and 112 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, 21-23, 33, 38-40, 42, & 44 of copending Application No. 18/558,885 (reference application; PGPub US 20240229073 A1; hereinafter referred to as ‘885) in view of Laer (PGPub US 2008124308 A1, published 5/29/2008).
New Objections
Claim Objections
Claim 215 is objected to because of the following informalities: on line 11, “the ORF encoding a optional second” should instead read “the ORF encoding an optional second”. Appropriate correction is required.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 208-212 and 224-225 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 208-212 and 224-225 require a replication competent arenavirus particle comprising a tri-segment genome comprising two S segments and one L segment, which comprise an open reading frame (ORF) encoding a fragment of an arenavirus GP1 and GP2 polypeptide, and optionally fused to a first heterologous non-arenaviral polypeptide; an ORF encoding a heterologous non-arenaviral signal peptide, and arenavirus GP1 and arenavirus GP2 fragments lacking an arenaviral GP signal peptide; ORFS encoding arenaviral NP, L, and Z proteins; and optionally an ORF encoding a second heterologous non-arenaviral polypeptide, wherein each ORF is under control of a separate arenaviral UTR (claim 208).
The metes and bounds of the claim are unclear because it is unclear in which genomic segments are the first and second ORFs. There are too many ways to organize the genes within a replication competent arenavirus particle comprising a tri-segmented genome comprising two S segments and one L segment, such that a person having ordinary skill in the art is not informed of the scope of the claims. The claims are very broad, such that their scope is unclear.
See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (“[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.”).
Claims 209-212 and 224-225 do not clarify the scope of the claims by requiring the ORFs to be in particular genomic segments, and are thus also indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 208-227 are rejected under 35 U.S.C. 103 as being unpatentable over Bonilla, et al. (WO2017198726A1, published 11/23/2017, on IDS) in view of Belnoue, et al. (PGPub US20160024476A1, published 1/28/2016, on IDS), Schrempf, et al. (J. Virol. Nov. 2007. Vol. 81, No. 22, on IDS), and Agnihothram, et al. (J. Virol. June 2006, p. 5189-5198, Vol. 80, No. 11, on IDS).
The claimed invention encompasses a replication competent arenavirus particle comprising a tri-segmented genome comprising two S segments and one L segment, which comprise: an open reading frame (ORF) encoding a fragment of an arenavirus GP comprising its signal peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide, and optionally fused to a first heterologous non-arenaviral polypeptide; an ORF encoding a heterologous non-arenaviral signal peptide, and arenavirus GP1 and arenavirus GP2 fragments lacking an arenaviral GP signal peptide; ORFS encoding arenaviral NP, L, and Z proteins; and optionally an ORF encoding a second heterologous non-arenaviral polypeptide, wherein each ORF is under control of a separate arenaviral UTR (claim 1).
The Prior Art
Bonilla teaches Pichinde viruses with rearrangements of their open reading frames (ORFs) in their genomes, wherein a modified Pichinde virus genomic segment is engineered to carry a viral ORF in a position other than the wild-type position of the ORF, as well as trisegmented Pichinde virus particles comprising one L segment and two S segments, which may be suitable for vaccines, treatment of diseases, and/or use in immunotherapies (Abstract). Bonilla discloses that its infectious Pichinde virus viral vectors may be replication-competent or replication-deficient (para. [0009]). Additionally, the heterologous ORF may encode a reporter protein, or an antigen derived from an infectious organism, tumor, or allergen (paras. [0017] and [0034]).
Bonilla also discloses a variety of genome organizations of its tri-segmented Pichinde virus particles comprising one L segment and two S segments, including combinations of genes encoding heterologous ORFs, GP, NP, Z, and L ORFs under the control of S segment 5’ UTRs, 3’ UTRs, L segment 5’ UTRs and 3’ UTRs (para. [0126] and Table 2A). Specifically, Bonilla discloses viral particles with an L segment encoding Z under the control of the 5’ UTR, L under the control of the 3’ UTR, an S segment encoding a heterologous ORF under the control of the 5’ UTR and GP under the control of 3’ UTR, and the other S segment encoding a heterologous ORF under the control of the 5’ UTR and NP under the control of the 3’ UTR (Table 2A; Fig. 6). Additionally, Bonilla discloses a large number of genome configurations for the ORFs (Table 2A). Bonilla specifically teaches in certain embodiments, the two S segments comprise one or two heterologous ORFs from an organism other than a Pichinde virus (para. [0032]; Table 2A).
However, Bonilla does not teach an ORF encoding a fragment of an arenavirus GP comprising its signal peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide, or an ORF encoding a heterologous non-arenaviral signal peptide, and arenavirus GP1 and arenavirus GP2 fragments lacking an arenaviral GP signal peptides.
Belnoue discloses genetically modified arenaviruses suitable as vaccines against mycobacterial infections, as well as pharmaceutical compositions and methods for the prevention and treatment of mycobacterial infections (Abstract). Belnoue further discloses the modified arenaviruses may contain an antigen that is fused to a signal peptide for targeting a mycobacterial antigen to the endoplasmic reticulum (paras. [0080-0081]). Additionally, Belnoue discloses the nucleotide sequence encoding a mycobacterial antigen may be oriented in sense or antisense direction (para. [0050]). Belnoue also discloses that arenaviruses for use with its methods and compositions can be Old World viruses like Lassa virus, LCMV, Mobala, Mopeia, or Ippy virus, or New World viruses, like Amapari virus, Flexal virus, Guanarito virus, Junin virus, Latino virus, Machupo virus, Oliveros virus, Parana virus, Pichinde virus, Pirital virus, Sabia virus, Tacaribe virus, Tamiami virus, Bear Canyon virus, or Whitewter Arroyo virus (para. [0055]).
Belnoue also discloses antigens being fused to an N-terminal signal peptide that is the signal peptide of tissue plasminogen activator (para. [0014]), and also directly contemplates “in other embodiments, the nucleic acid sequence encoding the mycobacterial antigen is fused to the open reading frame (ORF) of glycoprotein GP, the matrix protein Z, the nucleoprotein NP, or the polymerase protein L” (para. [0091]; see also claim 33).
Schrempf teaches that most secretory and membrane proteins are synthesized as preproteins with an N-terminal signal sequence that is often cleaved off after insertion into the membrane of the endoplasmic reticulum (ER), and the signal peptides of LCMV GP-C, Lassa virus, and Junin virus are long-lived and accumulate in the membrane, wherein the signal peptide targets the GP to the ER membrane (p. 12414, col. 1, paras. 1-2; Fig. 1).
Agnihothram teaches recombinant arenavirus GP-C constructs in which SSP is replaced by a conventional signal peptide do not undergo significant proteolytic maturation by the SKI-1/S1P protease, but this defect for Lassa fever virus is rescued by coexpression of SSP in trans (pp. 5189-90, bridging para.). Agnihothram discloses a Junin virus CD4sp-GPC construct in which SSP was replaced by the conventional signal peptide of CD4, and its coexpression with an SSP construct in which a stop codon was introduced following the C-terminal SSP amino acid T58 (p. 5190, col. 1, last para.). Agnihothram also discloses that the CD4sp-GPC was unable to undergo efficient maturation, as is also seen with Lassa fever virus, wherein the deficiency in proteolytic cleavage in the absence of SSP is reversed by coexpression of SSP in trans (p. 5191, col. 1, para. 2). Agnihothram teaches that expression of the CD4sp-GPC glycoprotein in the absence of SSP generated the 60-kDa G1-G2 precursor, but considerably lesser amounts of the cleaved glycoproteins, in contrast to when SSP is expressed in trans, which enabled efficient cleavage of the G1-G2 precursor glycoprotein to produce mature G1 and G2 subunits (Fig. 2; p. 5191, col. 1). Agnihothram further teaches that cell-cell fusion is readily detected after transfection of the native GP-C glycoprotein, but absent in cells expressing the CD4sp-GPC glycoprotein in the absence of SSP (pp. 5191-92, bridging para.; Fig. 3). Co-expression of SSP reconstituted cell-cell fusion activity in the trans-complemented CD4sp-GPC complex to levels greater than those seen with the native GP-C glycoprotein (pp. 5191-92, bridging para.; Fig. 3). Agnihothram teaches that SSP is essential for GP-C transport to the Golgi and the cell surface, and in the absence of SSP, the G1-G2 precursor is localized to the ER, and CD4sp-GPC does not transport to the cell surface (p. 5192). Agnihothram teaches that the arenavirus GP-C precursor has a stable signal peptide domain, receptor-binding (G1), and transmembrane fusion (G2) subunits (p. 5189, col. 2), in that order from 5’-3’ (Fig. 1).
In order to rely on equivalence as a rationale supporting an obviousness rejection, the equivalency must be recognized in the prior art, and cannot be based on applicant’s disclosure or the mere fact that the components at issue are functional or mechanical equivalents. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958) (The mere fact that components are claimed as members of a Markush group cannot be relied upon to establish the equivalency of these components. However, an applicant’s expressed recognition of an art-recognized or obvious equivalent may be used to refute an argument that such equivalency does not exist.); Smith v. Hayashi, 209 USPQ 754 (Bd. of Pat. Inter. 1980) (The mere fact that phthalocyanine and selenium function as equivalent photoconductors in the claimed environment was not sufficient to establish that one would have been obvious over the other. However, there was evidence that both phthalocyanine and selenium were known photoconductors in the art of electrophotography. "This, in our view, presents strong evidence of obviousness in substituting one for the other in an electrophotographic environment as a photoconductor." 209 USPQ at 759.) MPEP §2144.06(II).
The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). MPEP §2144.07.
It would have been obvious to one of ordinary skill in the art to make and use an arenavirus encoding an ORF encoding an arenavirus GP signal peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide fused to a first heterologous non-arenaviral polypeptide, because Schrempf and Agnihothram disclose that arenaviral signal peptides target polypeptides to the ER, and Belnoue discloses that its arenaviruses may contain an antigen that is fused to a signal peptide for targeting the antigen to the endoplasmic reticulum (paras. [0080-0081]). Because arenaviral GP signal peptides are known to direct proteins to the ER, they are recognized by the art to be equivalents to known for the same purpose and suitable for the intended purpose of the signal peptides disclosed by Belnoue, for targeting an antigen to the endoplasmic reticulum. Accordingly, utilizing an arenavirus SSP as the signaling peptide for a heterologous ORF such as an antigen, to target the antigen to the ER would have been obvious to one of ordinary skill in the art, as would arenaviral particles encoding such a construct.
Similarly, it would have been obvious to one of ordinary skill in the art for the arenavirus to further comprise an ORF encoding a heterologous non-arenaviral signal peptide, and arenavirus GP1 and arenavirus GP2 fragments, lacking an arenaviral GP signal peptide. Agnihothram discloses that a Junin virus CD4sp-GPC construct in which the arenavirus GP SSP was replaced by the conventional signal peptide of CD4 localized to the ER, and trans-complementation with arenavirus SSP enabled theCD4sp-GPC construct to transport to be properly cleaved, transport to the cell surface, and mediate fusion. Because CD4 signaling peptides are known to direct arenavirus GP protein to the ER, as demonstrated by Agnihothram, they are recognized by the art to be equivalents to the arenavirus SSP, known for the same purpose and suitable for the intended purpose of targeting arenavirus GP to the endoplasmic reticulum. Accordingly, replacing the arenavirus GP SSP with another signaling peptide, or specifically the CD4 signaling peptide, would have been obvious to one of ordinary skill in the art, as would arenaviral particles encoding such construct. Such a construct, would comprise arenavirus GP1 and GP2 fragments, as those are the other GP domains than SSP, as disclosed by Agnihothram.
Although the art recognizes the special function of arenaviral signaling peptides for facilitating processing of arenaviral GP, and its subsequent transport to the cell surface and fusion activity, these functions can be conferred by arenavirus SSP supplied in trans, as demonstrated by Agnihothram, and so a person having ordinary skill in the art would recognize that utilizing an arenavirus particle comprising ORFs encoding both a fragment of an arenavirus GP comprising its signaling peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide, and an ORF encoding a heterologous non-arenaviral signal peptide, and arenavirus GP1 and GP2 fragments lacking an arenaviral GP signal peptide, would allow for normal GP processing and function, while at the same time enabling transport of a heterologous antigen to the ER.
The arenavirus particle being replication competent and comprising a tri-segmented genome comprising two segments and one L segment would have been obvious to one of ordinary skill in the art because Bonilla discloses as trisegmented Pichinde virus particles comprising one L segment and two S segments, which may be suitable for vaccines, treatment of diseases, and/or use in immunotherapies, and replication-competent. Bonilla also specifically discloses arenavirus particles encoding arenaviral NP, L, and Z proteins, as well as first and second non-arenaviral polypeptides, wherein each ORF is under control of a separate arenaviral UTR.
Regarding the tri-segmented genome comprising a second heterologous non-arenaviral polypeptide, that would be obvious because Bonilla discloses the two S segments comprise one or two heterologous ORFs from an organism other than a Pichinde virus (para. [0032]; Table 2A).
Regarding the genome configuration of the arenaviral particle, Bonilla discloses a number of different positions for each of the heterologous ORFs, GP, NP, Z, and L ORFS, and their control by 5’ or 3’ UTRs. In one embodiment, Bonilla discloses viral particles with an L segment encoding Z under the control of the 5’ UTR, L under the control of the 3’ UTR, an S segment encoding a heterologous ORF under the control of the 5’ UTR and GP under the control of 3’ UTR, and the other S segment encoding a heterologous ORF under the control of the 5’ UTR and NP under the control of the 3’ UTR (Table 2A; Fig. 6). Accordingly, it would have been obvious to one of ordinary skill in the art to configure an arenaviral particle in such manner. The instant specification indicates that the heterologous non-arenaviral polypeptide and the second heterologous non-arenaviral polypeptide are the same or different from each other (para. [0015]).
When interpreting the position of the heterologous ORF disclosed by Bonilla to be akin to the claimed “ORF encoding a fragment of an arenavirus GP comprising its signal peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide fused to a first non-arenaviral polypeptide”, and the position of the GP disclosed by Bonilla to be akin to an ORF encoding a heterologous non-arenaviral signal peptide, and arenavirus GP1 and arenavirus GP2 fragments lacking an arenaviral GP signal peptide (Bonilla, Table 2A), the configurations disclosed by Bonilla meets the configuration requirements of claims 208-213, 215-219, and 226-227.
Those configurations include the L segment comprising the ORFs encoding arenaviral L and Z proteins (claim 212), one S segment comprises the ORF encoding a fragment of an arenavirus GP comprising its signal peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide, optionally fused to the first heterologous non-arenaviral polypeptide, and the ORF encoding a heterologous non-arenaviral signal peptide, arenavirus GP1 and arenavirus GP2 fragment lacking an arenaviral GP signal peptide; and the other S segment comprises the ORF encoding arenaviral NP protein, and the ORF encoding an optional second heterologous non-arenaviral polypeptide (claim 213). Also included is one S segment comprises the ORF encoding a fragment of an arenavirus GP comprising its signal peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide and optionally fused to a first heterologous non-arenaviral polypeptide, and the ORF encoding arenaviral NP protein, and the other S segment comprises the ORF encoding a heterologous non-arenaviral signal peptide, arenavirus GP1 and arenavirus GP2 fragment lacking an arenaviral GP signal peptide, and the ORF encoding an optional second heterologous non-arenaviral polypeptide (claim 215). Also included is the L segment comprising the ORF encoding arenaviral Z protein under control of a 5’ UTR, and the ORF encoding arenaviral L protein under control of a 3’ UTR; one S segment comprises the ORF encoding a heterologous non-arenaviral signal peptide, arenavirus GP1 and arenavirus GP2 fragment lacking an arenaviral GP signal peptide under control of a 5’ UTR, and the ORF encoding a fragment of an arenavirus GP comprising its signal peptide but lacking a full length arenavirus GP1 and GP2 polypeptide, and optionally fused to a first heterologous non-arenaviral polypeptide under control of a 3’ UTR, and the other S segment comprises optionally, the ORF encoding a second heterologous non-arenaviral polypeptide under control of a 5’ UTR and the ORF encoding arenaviral NP protein under control of a 3’ UTR (claim 216), wherein the ORF encoding an arenavirus GP signal peptide fragment lacking a full-length arenavirus GP1 and GP2 polypeptide is fused to a first heterologous non-arenaviral polypeptide (claim 217), wherein the other S segment comprises the ORF encoding a second heterologous non-arenaviral polypeptide (claim 218), or wherein the ORF encoding a fragment of an arenavirus GP comprising its signal peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide is fused to a first non-arenaviral polypeptide; and wherein the other S segment comprises the ORF encoding a second heterologous non-arenaviral polypeptide (claim 219).
Those configurations also include the L segment comprises the ORF encoding arenaviral Z protein under control of a 5’ UTR, and the ORF encoding arenaviral L protein under control of a 3’ UTR; one S segment comprises optionally the ORF encoding a second heterologous non-arenaviral polypeptide under control of a 5’ UTR, and the ORF encoding a heterologous non-arenaviral signal peptide, arenavirus GP1 and arenavirus GP2 fragment lacking an arenaviral GP signal peptide under control of a 3’ UTR; and the other S segment comprises the ORF encoding a fragment of an arenavirus GP comprising its signal peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide, and optionally fused to a first heterologous non-arenaviral polypeptide under control of a 5’ UTR, and the ORF encoding arenaviral NP protein under control of a 3’ UTR (claim 226), or wherein the L segment comprises the ORF encoding arenaviral Z protein under control of a 5’ UTR, and the ORF encoding arenaviral L protein under control of a 3’ UTR; one S segment comprises the ORF encoding a fragment of an arenavirus GP comprising its signal peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide, and optionally fused to a first heterologous non-arenaviral polypeptide under control of a 5’ UTR, and the ORF encoding a heterologous non-arenaviral signal peptide, arenavirus GP1 and arenavirus GP2 fragment lacking an arenaviral GP signal peptide under control of a 3’ UTR; and the other S segment comprises, optionally, the ORF encoding a second heterologous non-arenaviral polypeptide under control of a 5’ UTR, and the ORF encoding arenaviral NP protein under control of a 3’ UTR (claim 227).
Additionally, Bonilla discloses a large number of genome configurations for the ORFs, so it would have been obvious to one of ordinary skill in the art that the different ORFs could be placed at different positions of the L segment and two S segments, under the control of the segments’ respective 5’ UTRs or 3’ UTRs (Table 2A). Those configurations include: wherein the L segment comprises the ORFs encoding arenaviral L and Z proteins, one S segment comprises the ORF encoding a fragment of an arenavirus GP comprising its signal peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide, and optionally fused to a first heterologous non-arenaviral polypeptide, and the ORF encoding an optional second heterologous non-arenaviral polypeptide; and the other S segment comprises the ORF encoding arenaviral NP protein, and the ORF encoding a heterologous non-arenaviral signal peptide, arenavirus GP1 and arenavirus GP2 fragment lacking an arenaviral GP signal peptide (claim 214). Or where, the L segment comprises the ORF encoding arenaviral Z protein under control of a 5’ UTR, and the ORF encoding arenaviral L protein under control of a 3’ UTR; one S segment comprises optionally, the ORF encoding a second heterologous non-arenaviral polypeptide under control of a 5’ UTR, and the ORF encoding a fragment of an arenavirus GP comprising its signal peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide, and optionally fused to a first heterologous non-arenaviral polypeptide under control of a 3’ UTR; and the other S segment comprises the ORF encoding a heterologous non-arenaviral signal peptide, arenavirus GP1 and arenavirus GP2 fragment lacking an arenaviral GP signal peptide under control of a 5’ UTR, and the ORF encoding arenaviral NP protein under control of a 3’ UTR (claim 220), comprising the ORF encoding a second heterologous non-arenaviral polypeptide under control of a 5’ UTR, and wherein the ORF encoding a fragment of an arenavirus GP comprising its signal peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide is fused to a first heterologous non-arenaviral polypeptide under control of a 3’ UTR (claim 221), alternatively, comprising the ORF encoding a second heterologous non-arenaviral polypeptide under control of a 5’ UTR (claim 222), or rather the ORF encoding a fragment of an arenavirus GP comprising its signal peptide but lacking a full-length arenavirus GP1 and GP2 polypeptide is fused to a first heterologous non-arenaviral polypeptide under control of a 3’ UTR (claim 223).
Regarding claims 224-225, which require the first (claim 224) or second (claim 225) heterologous non-arenaviral polypeptide to be an antigen derived from an infectious organism, tumor, or allergen, those would have been obvious to one of ordinary skill in the art because Bonilla discloses arenavirus particles encoding antigens derived from an infectious organism, tumor, or allergen.
One of ordinary skill in the art would have been motivated to provide arenavirus compositions for vaccinations. There would be a reasonable expectation of success because Bonilla discloses tri-segmented arenavirus particles with similar gene configurations. Therefore, claims 208-227 were prima facie obvious before the priority date of the instant invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 208-227 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21-23, and 33 of copending Application No. 18/558,885 (reference application; PGPub US 20240229073 A1; hereinafter referred to as ‘885) in view of Bonilla, et al. (WO2017198726A1, published 11/23/2017, on IDS) in view of Belnoue, et al. (PGPub US20160024476A1, published 1/28/2016, on IDS), Schrempf, et al. (J. Virol. Nov. 2007. Vol. 81, No. 22, on IDS), and Agnihothram, et al. (J. Virol. June 2006, p. 5189-5198, Vol. 80, No. 11, on IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because set of claims encompasses engineered arenavirus particles comprising nucleotide sequences, including tri-segmented genomes with one L segment and two S segments (instant claims 208-227 and reference claim 1). Additionally, each claim set encompasses similar configuration of the ORFs on arenavirus genome segments, particular arenaviral genes, include polypeptide fragments, non-arenaviral polypeptides, control of the nucleotide sequences by 3’ and 5’ UTRs, and signal peptides fused to the arenaviral and non-arenaviral polypeptides (instant claims 208-227, reference claim 1). Also, each set of claims includes ORFs an arenavirus GP signal peptide and a first heterologous non-arenaviral polypeptide and a heterologous non-arenaviral signal peptide, arenavirus GP1, and arenavirus GP2 (instant claims, reference claim 1). Each set of claims includes similar antigens, including those of infectious organisms, tumor, or allergens (instant claims 224-225, reference claim 33), and encompasses the arenavirus particle being a Pichinde virus (instant claim 211, reference claim 22).
The teachings of Bonilla, Belnoue, Schrempf, and Agnihothram are discussed above in the rejection under 35 U.S.C. §103. As discussed in the rejection under 35 U.S.C. §103 above, the cited references render obvious the genome configuration with respect to particular arenaviral or heterologous ORFs at specific genome positions and under the control of specific UTRs.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
No claim is allowed.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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