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 .
Election/Restrictions
Applicant’s election of Inventive Group I, claims 1, 5-6, 15-16, 22, 26-27, 29, 33-35, 55, 57-60, 108, and 112, and the required species, in the reply filed on 8/5/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 51-52 & 56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/5/2025.
Applicant elected the following species:
A particular second polypeptide: “a functional fragment of the first polypeptide, and the second ORF does not encode the full-length first polypeptide” as recited in claim 1, subsection b. Upon further consideration, the examiner has withdrawn the election of species requirement of Group A).
A specific first polypeptide amino acid sequence: SEQ ID NO: 1 as the elected “second polypeptide is a functional fragment of the recited “first” polypeptide.
Claims 1, 5-6, 15-16, 22, 26-27, 29, 33-35, 55, 57-60, 108, and 112 are under examination on the merits.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 11/16/2022 is in compliance with 37 CFR 1.97. Accordingly the IDS is being considered by the examiner.
Claim Objections
Claim 27 is objected to because of the following informalities: it recites the term “helicobacter” multiple times, on lines 12 and 16. Appropriate correction is required.
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 1, 5-6, 15-16, 22, 26-27, 29, 33-35, 55, 57-60, 108, and 112 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 1, 6, 108, and 112 include the limitation of “a functional fragment” of a first and/or second polypeptide. However, the claims also require that the first and/or second polypeptides are arenavirus GP, NP, Z, or L proteins. The claims are indefinite because arenavirus GP, NP, Z, or L proteins are known to have multiple functions, and thus it is not clear what function the fragment must serve. For instance, Burri, et al. (Viruses. 2012 Oct 17;4(10):2162-81. PMID: 23202458) discloses that the arenavirus GP stable signal peptide (SSP) targets nascent GPC polypeptide into ER, and forms SSP/GP1/GP2 complexes (p. 2167, para. 1, section 2.1). Additionally, the SSP K33 residue is an important determinant for pH-dependent fusion of the glycoprotein with host cell membrane (Id.). The specification (p. 37) defines “functional fragment” to mean a fragment of a polypeptide. It is unclear which functional fragments of arenavirus GP the claims are referring to. Claims 5, 15-16, 22, 26-27, 29, 33-35, 55, and 57-59 depend from claim 1 but do not provide clarity, and are thus also indefinite.
Claims 1, 6, 108, and 112 recite the limitation "the full-length first polypeptide" in lines 5, 5, 4, and 4, respectively. There is insufficient antecedent basis for this limitation in the claims. Claims 5, 15-16, 22, 26-27, 29, 33-35, 55 and 57-59 depend from claim 1 and are thus also indefinite.
Claim 16 recites “the arenavirus GP1 and GP2” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 60 recites the limitation “engineered such that an arenaviral ORF is separated over two or more mRNA transcripts.” It is unclear what the term “engineered such” means, whether two mRNA transcripts are used to generate the particle, or whether the particle actually possesses the two mRNA transcripts.
Claim 108 recites the limitation “the full-length second polypeptide” in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, 29, 33, 55, 57-60, 108, and 112 are rejected 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; hereinafter referred to as “Zaza”).
The claimed invention encompasses a nucleotide sequence comprising a first open reading frame (ORF) and a second ORF, wherein one of the two ORFs is in sense orientation and the other ORF is in antisense orientation; wherein the first ORF comprises a nucleotide sequence encoding a functional fragment of a first polypeptide, and the first ORF does not encode the full-length first polypeptide; wherein the second ORF comprises a nucleotide sequence encoding: a) a second polypeptide; or b) a functional fragment of the first polypeptide, and the second ORF does not encode the full-length first polypeptide; or c) a functional fragment of a second polypeptide, and the second ORF does not encode the full-length second polypeptide; or d) a heterologous non-arenaviral polypeptide; and wherein the first and second polypeptides are different from each other and selected from the group consisting of arenavirus GP, NP, Z, and L (claim 1) of Machupo virus (claim 5). Alternatively, a DNA expression vector comprising the nucleotide sequence (claim 55). The claimed invention also encompasses a translation product of the nucleotide sequence (claim 29), or an arenavirus particle containing a genome comprising the nucleotide sequence, wherein the arenavirus particle is tri-segmented and comprises two S segments and an L segment (claim 33).
Other embodiments encompass a host cell comprising the nucleotide sequence, vaccine with a pharmaceutically acceptable carrier, or pharmaceutical composition and a pharmaceutically acceptable carrier comprising the nucleotide sequence (claims 57-59).
Another embodiment encompasses an arenavirus genomic or antigenomic segment engineered such that the viral transcription thereof results in a first mRNA transcript and a second mRNA transcript, wherein the first mRNA transcript comprises a nucleotide sequence encoding a functional fragment of a first polypeptide, and the first mRNA transcript does not encode the full-length first polypeptide; wherein the second mRNA transcript comprises a nucleotide sequence encoding: a) a second polypeptide; or b) a functional fragment of the first polypeptide, and the second mRNA transcript does not encode the full-length first polypeptide; or c) a functional fragment of a second polypeptide, and the second mRNA transcript does not encode the full-length second polypeptide; or d) a heterologous non-arenaviral polypeptide; and wherein the first and second polypeptides are different from each other and selected from the group consisting of: arenavirus GP, NP, Z, and L (claim 108).
Another embodiment encompasses an arenavirus genomic or antigenomic segment engineered such that the viral transcription thereof results in an mRNA transcript encoding: a) a functional fragment of a first polypeptide, and b) a heterologous non-arenaviral polypeptide or a second polypeptide; wherein the mRNA transcript does not encode the full-length first polypeptide; and wherein the first and second polypeptides are different from each other and selected from the group consisting of an arenavirus GP, NP, Z, and L (claim 112).
The claimed invention also encompasses an arenavirus particle engineered such that an arenaviral ORF is separated over two or more mRNA transcripts (claim 60).
MPEP §2113 recites, “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”
Claim 60 is indefinite for the reason described above in the rejection under 35 U.S.C. §112(b). However, if it is interpreted such that the claim means the arenavirus particle is produced using a system where an ORF is separated over two or more mRNA transcripts, the claim is interpreted to be a product by process claim. Specifically, the claim limitation “engineered such that an arenaviral ORF is separated over two or more mRNA transcripts” is interpreted as a product by process claim. Therefore, if the prior art teaches an engineered arenavirus particle, the claimed invention is anticipated thereby.
The Prior Art
Zaza discloses a Machupo virus (MACV) arenavirus construct, r3MACV, which comprises one S segment that encodes the MACV GPC and the GTOV GPCΔ33, and the other encodes the CHAPV GPCΔ33 and the MACV NP, and the L segment is unchanged from the wild-type genome (Fig. 1B; p. 2). Thirty three amino acids were deleted from the C-termini of the two GPC sequences, required for production of infectious viral particles and to avoid any competition with the MACV wt GPC (p. 2, col. 1, para. 2). r3MACV when used as a vaccine protected 50% of guinea pigs from a simultaneous lethal Junin virus challenge (Findings; Fig. 4). Zaza utilized reverse genetic systems using synthesized Z, GPC, NP, NP D380A, and L genes, as well as S and L backbones, and the genes were cloned into backbones or pCAGGs plasmids (p. 2, col. 2). Zaza discloses the guinea pigs were inoculated by intraperitoneal injection with the arenavirus constructs in 0.5 mL of PBS (p. 4, col. 1).
Therefore, Zaza anticipates claims 1, 5, 29, 33, 55, 57-60, 108, and 112.
Claim Rejections - 35 USC § 103
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.
Claim 22 is rejected 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; hereinafter referred to as “Laer”).
In a specific embodiment, the first polypeptide comprises an amino acid sequence that is at least 80% identical to the amino acid sequence of SEQ ID NO: 1; and wherein the second polypeptide comprises an amino acid sequence at least 80% identical to SEQ ID NO: 1 (claim 22).
The Prior Art
The teachings of Zaza are described above. Zaza further discloses similar construct configurations using LCMV, wherein a tri-segmented LCMV, r3LCMV, could carry two genes of interest and showed high attenuation vs WT and exhibited protection against LCMV challenge when used as a vaccine candidate in mice (p. 2, col. 1).
However, Zaza does not teach a sequence that is at least 80% identical to SEQ ID NO: 1.
Laer discloses retroviral virions pseudotyped with arenavirus glycoprotein for gene therapy of solid tumors (Abstract). Laer further discloses the arenavirus glycoprotein is an LCMV glycoprotein, and specifically discloses an LCMV glycoprotein sequence, SEQ ID NO: 26, which is 100% identical to the instant SEQ ID NO: 1 (claims 50-51; SEQ ID NO: 26). An ABSS sequence alignment summary of the instant SEQ ID NO: 1 and Laer’s SEQ ID NO: 26 is below.
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It would have been obvious to one of ordinary skill in the art to modify the tri-segmented arenaviruses taught by Zaza to incorporate the LCMV GP sequence disclosed by Laer (SEQ ID NO: 26). Zaza teaches vaccines that provide immunization against multiple arenaviruses by expressing a GP from another arenavirus. Laer discloses the LCMV GP sequence that is identical to the instant SEQ ID NO: 1. One of ordinary skill in the art would have been motivated to immunize against LCMV GP. There would be a reasonable expectation of success because Zaza teaches immunization against other arenaviruses using the r3MACV vector. Therefore, claim 22 was prima facie obvious before the priority date of the instant invention.
Claims 1, 5, 6, 15, 16, 26, 27, 29, 33-35, 55, 57-60, 108 and 112 are rejected 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; hereinafter referred to as “Belnoue”) 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; hereinafter referred to as “Schrempf”).
The claimed invention also encompasses a nucleotide sequence comprising an open reading frame (ORF), wherein the ORF comprises a nucleotide sequence encoding a) a functional fragment of a first polypeptide, and b) a second polypeptide; wherein the ORF does not encode the full-length first polypeptide; and wherein the first and second polypeptides are different from each other and selected from the group consisting of: arenavirus GP, NP, Z, and L that are not from Lassa virus (claim 6).
In one embodiment of the claimed invention, the first ORF comprises a nucleotide sequence encoding arenavirus GP signal peptide, either alone or fused to a heterologous non-arenaviral polypeptide (claim 15). In a particular embodiment, the second ORF comprises a nucleotide sequence encoding a heterologous non-arenaviral signal peptide and the arenavirus GP1 and GP2. In another embodiment, the heterologous non-arenaviral polypeptide, the second heterologous non-arenaviral polypeptide, or both heterologous non-arenaviral polypeptides are each an antigen derived from an infectious organism, tumor, or allergen (claim 26), or the antigen is more specifically a bacterial antigen of the family mycobacteriaceae (claim 27).
In a specific embodiment of the claimed invention, the genome of the arenavirus particle consists of: a) an S segment that encodes arenavirus GP signal peptide and a heterologous non-arenaviral polypeptide under the control of an arenavirus 3’ UTR and a heterologous non-arenaviral signal peptide, arenavirus GP1 and arenavirus GP (claim 34) or another heterologous non-arenaviral polypeptide or no polypeptide (claim 35) under the control of an arenavirus 5’ UTR; b) an S segment that encodes NP under the control of an arenavirus 3’ UTR and another heterologous non-arenaviral polypeptide or no polypeptide (claim 34) or a heterologous non-arenaviral signal peptide, arenavirus GP1, and arenaviral GP2 (claim 35) under the control of an arenavirus 5’ UTR; and c) an L segment that encodes L protein under the control of an arenavirus 3’ UTR and Z protein under the control of an arenavirus 5’ UTR; and wherein the two heterologous non-arenaviral polypeptides are the same or different from each other.
The claimed invention encompasses a nucleotide sequence comprising a first open reading frame (ORF) and a second ORF, wherein one of the two ORFs is in sense orientation and the other ORF is in antisense orientation; wherein the first ORF comprises a nucleotide sequence encoding a functional fragment of a first polypeptide, and the first ORF does not encode the full-length first polypeptide; wherein the second ORF comprises a nucleotide sequence encoding: a) a second polypeptide; or b) a functional fragment of the first polypeptide, and the second ORF does not encode the full-length first polypeptide; or c) a functional fragment of a second polypeptide, and the second ORF does not encode the full-length second polypeptide; or d) a heterologous non-arenaviral polypeptide; and wherein the first and second polypeptides are different from each other and selected from the group consisting of arenavirus GP, NP, Z, and L (claim 1) of Machupo virus or one of many other specific arenaviruses (claim 5). Alternatively, a DNA expression vector comprising the nucleotide sequence (claim 55). The claimed invention also encompasses a translation product of the nucleotide sequence (claim 29), or an arenavirus particle containing a genome comprising the nucleotide sequence, wherein the arenavirus particle is tri-segmented and comprises two S segments and an L segment (claim 33).
Other embodiments encompass a host cell comprising the nucleotide sequence, vaccine with a pharmaceutically acceptable carrier, or pharmaceutical composition and a pharmaceutically acceptable carrier comprising the nucleotide sequence (claims 57-59).
Another embodiment encompasses an arenavirus genomic or antigenomic segment engineered such that the viral transcription thereof results in a first mRNA transcript and a second mRNA transcript, wherein the first mRNA transcript comprises a nucleotide sequence encoding a functional fragment of a first polypeptide, and the first mRNA transcript does not encode the full-length first polypeptide; wherein the second mRNA transcript comprises a nucleotide sequence encoding: a) a second polypeptide; or b) a functional fragment of the first polypeptide, and the second mRNA transcript does not encode the full-length first polypeptide; or c) a functional fragment of a second polypeptide, and the second mRNA transcript does not encode the full-length second polypeptide; or d) a heterologous non-arenaviral polypeptide; and wherein the first and second polypeptides are different from each other and selected from the group consisting of: arenavirus GP, NP, Z, and L (claim 108).
Another embodiment encompasses an arenavirus genomic or antigenomic segment engineered such that the viral transcription thereof results in an mRNA transcript encoding: a) a functional fragment of a first polypeptide, and b) a heterologous non-arenaviral polypeptide or a second polypeptide; wherein the mRNA transcript does not encode the full-length first polypeptide; and wherein the first and second polypeptides are different from each other and selected from the group consisting of an arenavirus GP, NP, Z, and L (claim 112).
The claimed invention also encompasses an arenavirus particle engineered such that an arenaviral ORF is separated over two or more mRNA transcripts (claim 60).
MPEP §2113 recites, “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”
Claim 60 is indefinite for the reason described above in the rejection under 35 U.S.C. §112(b). However, if it is interpreted such that the claim means the arenavirus particle is produced using a system where an ORF is separated over two or more mRNA transcripts, the claim is interpreted to be a product by process claim. Specifically, the claim limitation “engineered such that an arenaviral ORF is separated over two or more mRNA transcripts” is interpreted as a product by process claim. Therefore, if the prior art teaches an engineered arenavirus particle, the claimed invention is anticipated thereby.
The Prior Art
Belnoue teaches 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. 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).
However, Belnoue does not teach a nucleotide sequence encoding a functional fragment of a first polypeptide that is an arenavirus GP, NP, Z, or L protein.
The teachings of Zaza are described above.
Schrempf teaches 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. 12515, col. 1, paras. 1-2; Fig. 1).
It would have been obvious to one of ordinary skill in the art to modify the genetically modified arenavirus to be of the genetic construct, wherein a mycobacterial antigen with an arenavirus GP signal peptide is encoded thereby. Belnoue teaches modified arenaviruses as vaccines against mycobacterial infections, wherein the modified arenavirus contains a mycobacterial antigen fused to a signal peptide for targeting the antigen to the ER. Zaza teaches recombinant arenavirus constructs used for vaccines, and Schrempf teaches that arenavirus signal peptides, such as LCMV, Lassa, and Junin virus GPs can target a polyprotein to the ER. One of ordinary skill in the art would have been motivated to vaccinate against mycobacteria. There would be a reasonable expectation of success because . Therefore, claims 1, 5, 6, 15, 16 26, 27, 29, 33-35, 55, 57-60, 108, and 112 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 1, 5, 6, 15, 16, 22, 26, 27, 29, 33-35, 55, 57-60, 108, and 112 are 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 (supra). 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. 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. Each set of claims includes similar antigens, including those of infectious organisms, tumor, or allergens. Further, each set of claims encompasses embodiments wherein the nucleotide sequences are in pharmaceutical compositions in addition to a pharmaceutically acceptable carrier, and host cells comprising the nucleotide sequences.
Although ‘885 does not specifically teach aa polypeptide with an amino acid sequence that is at least 80% identical to SEQ ID NO: 1, it would have been obvious to use as an antigen encoded by the arenavirus construct because Laer discloses arenavirus constructs and that SEQ ID NO: 1 is an LCMV GP sequence. One of ordinary skill in the art would have been motivated to vaccinate against LCMV GP or construct arenavirus particles with LCMV specificity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY MARK SIFFORD whose telephone number is (571)272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671
/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671