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 .
Claims 1-20 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/21/24, 8/19/24, 10/30/25, 12/17/25 and 6/9/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objection-Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See pages 2, 25 and 27.
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below. The specification is objected to because paragraph 125 does not contain a specific SEQ ID NO: for the amino acid sequence GGSGGGGSGG.
Applicants must comply with sequence rules in order to be considered a complete response to this Office Action.
Objection-Drawings
The drawings are objected to because Figures 2 and 3 present labels for line graphs. However, the labels are unclear (blurry). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 18 is objected to because of the following informalities: the claim recites, “the first and second polynucleotides recited claim 1”. However, the claim should recite “the first and second polynucleotides recited of claim 1”. Appropriate correction is required.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-38 of copending No. 18/067,358 in view of Perri et al. (infra). Although the claims at issue are not identical, they are not patentably distinct from each other because claimed invention of ‘358 requires polynucleotide sequences encoding alphavirus NSP1-4 and an antigenic peptide, wherein at least one of the polynucleotides can comprise 5-methyl-cytidine. Similarly, the instant invention is drawn to an isolated polynucleotide encoding alphavirus NSP1-4, an antigenic peptide and a 5-methyl-cytidine. The claimed invention of ‘358 also requires that the alphavirus replicon encodes an antigenic peptide form a virus, such as SARS, more specifically SARS-CoV-2 and the antigen peptide contains a RBD of a spike protein from a coronavirus, such as SARS-CoV-2. The vaccine of the copending claims can be a multivalent vaccine (see claim 38 of ‘358). Furthermore, the invention of the copending application also requires the epitope of a PADRE, a signal sequence, the use of a transmembrane domain from an influenza HA, a vectors containing the replicons and methos of treating a SARS-CoV-2 infection. While the invention of the copending application does not require multiple alphavirus replicons being present as part of a bivalent vaccine, the teachings of Perri et al. (see below) provide sufficient teachings and suggestions of how to adapt the invention ‘358 to create such a bivalent vaccine.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method capable of inducing an immune response against an antigen encoded by the claimed alphavirus replicon vaccine, does not reasonably provide enablement for a method of treating or preventing an infectious disease by administering an antigen encoded by the claimed alphavirus replicon vaccine, particularly treating or preventing a SARS-CoV-2 infecious disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Nature of the invention/Breadth of the claims. The claims are drawn to a method of treating or preventing an infectious disease, such as SARS-CoV-2 by administering a bivalent alphavirus replicon vaccine, which is a combination a first polynucleotide which encodes alphavirus non-structural proteins nsp1, nsp2, nsp3 and nsp4 and an antigenic peptide and a second polynucleotide which encodes alphavirus non-structural proteins nsp1, nsp2, nsp3 and nsp4 and a CD8+ T cell epitope. While the method states that an infectious disease is to be treated or preventing, including SARS-CoV-2, the encoded antigenic peptide is not defined.
State of the prior art/Predictability of the art. The state of the art related to coronavirus vaccines, such as vaccines for vaccinating against COVID-19, teaches that some vaccines are effective at reducing severe illness, but that preventing infection is not realistic. For example, Table 19 presented herein is from the package insert of a SPIKEVAX injectable vaccine by ModernaTX, Inc. This vaccine has proven to be reliable at reducing the severity of COVID-19 infections. This version of the COVID-19 vaccine is a 2025-2026 formula. Table 19 summarized the vaccine efficacy of SPIKEVAX at 93% in all 14, 287 participates tested. However, approximately 9.6 per 1,000 Persons of those receiving the vaccine still contracted COVID-19. Therefore, the SPIKEVAX vaccine has been proven to be effective, but it did not prevent infection in all recipients that received it.
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Working examples. Applicants have provided a working example in which mice received sequences encoding the RBD of SARS-CoV-2 with or without the fusion to a PADRE epitope and mice exhibited weight loss following challenge with SARS-CoV-2. [see figure 5] This weight loss is indicative of an infection.
Amount of experimentation necessary. Additional research is required in order to determine how effective administering a bivalent alphavirus replicon vaccine, which is a combination a first polynucleotide which encodes alphavirus non-structural proteins nsp1, nsp2, nsp3 and nsp4 and an antigenic peptide and a second polynucleotide which encodes alphavirus non-structural proteins nsp1, nsp2, nsp3 and nsp4 and a CD8+ T cell epitope would be at treating or preventing an infectious disease, including SARS-CoV-2, particularly since the encoded antigenic peptide is not defined.
For the reasons discussed above, it would require undue experimentation for one skilled in the art to use the claimed methods.
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.
Claim 6 is 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.
Claim 6 recites the limitation "the coronavirus S1 subunit" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 recites, “wherein the antigenic peptide is derived from a coronavirus”, however claim 4, which it depends from, only provides two specific coronaviruses, and not the more generic grouping of “coronavirus”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 10 recites the same scope of claim limitations that claim 3 also recites and claim 10 depends from claim 3. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 2 rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of antigenic peptides is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the grouping includes viruses, bacterium, cancer or cytokines, which do not share a common structure or use.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim 4 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of pathogens is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the viruses and bacteria do not share a common structure or use.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 13 and 16-18 are rejected under 35 U.S.C. 102a1 as being anticipated by Perri et al. (US PG Pub 20090104226).
The claimed invention is drawn to a bivalent alphavirus replicon vaccine, which is a combination of a first polynucleotide which encodes alphavirus non-structural proteins nsp1, nsp2, nsp3 and nsp4 and an antigenic peptide and a second polynucleotide which encodes alphavirus non-structural proteins nsp1, nsp2, nsp3 and nsp4 and a CD8+ T cell epitope.
The antigenic peptide is a protein derived from a virus, such as a SARS virus, which is a coronavirus, and the antigenic protein/peptide can comprise the receptor binding domain of the SARS virus, which is present in the S1 subunit of the spike protein. The antigenic peptide that is a RBD is fused to a transmembrane domain and a CD4+ T cell epitope. The transmembrane domain can be a modified version of that from a protein that the RBD is part of. The antigenic peptide is also fused to a signal sequence. The replicon that encodes a CD8+ T cell epitope also possesses a signal sequence fused to the epitope.
The claimed invention also requires a combination of vectors that possess the first and second polynucleotides and the polynucleotides can be part of a bivalent alphavirus replicon vaccine that also comprises a pharmaceutically acceptable delivery vehicle.
For the purposes of this rejection, the limitation of modified transmembrane domain (see claim 8) is not defined in the specification and therefore will be interpreted as including such a domain from the viral protein encoded by the alphavirus replicon.
Perri et al. teach the generation of alphavirus replicons that express viral proteins. These proteins include influenza hemagglutinin (HA), neuraminidase (NA), SARS spike proteins and other viral surface proteins. [see paragraph 20] One specific example is the generation of two alphavirus replicons that each comprised ORFs for alphavirus non-structural proteins 1-4, a promoter and an operably linked influenza HA or NA. [see figure 2 and paragraphs 72 and 73] Perri et al. also teach the generation of an alphavirus replicon that expresses the alphavirus nonstructural proteins and the full spike protein of SARS and the Fusion protein of HMPV. [see figure 5 and paragraphs 72 and 73] It is also taught that the alphavirus replicons can be formulated with a pharmaceutically acceptable carrier, which meets the claim limitation of a vehicle [see paragraph 197]. Perri et al. additionally teach the generation of two alphavirus replicon particles, one encoding the spike protein from a SARS and the other encoding an HA of influenza. Upon administering these particles to mice, one after the other, antibody titers were observed. [see figure 20 and paragraph 370] Perri et al. also teach that An "antigen" refers to a molecule containing one or more epitopes (either linear, conformational or both) that will stimulate a host's immune system to make a humoral and/or cellular antigen-specific response. The term is used interchangeably with the term "immunogen." Normally, an epitope will include between about 3-15, generally about 5-15 amino acids. A B-cell epitope is normally about 5 amino acids but can be as small as 3-4 amino acids. A T-cell epitope, such as a CTL epitope, will include at least about 7-9 amino acids, and a helper T-cell epitope at least about 12-20 amino acids. Normally, an epitope will include between about 7 and 15 amino acids, such as, 9, 10, 12 or 15 amino acids. The term "antigen" denotes both subunit antigens, (i.e., antigens which are separate and discrete from a whole organism with which the antigen is associated in nature), as well as, killed, attenuated or inactivated bacteria, viruses, fungi, parasites or other microbes as well as tumor antigens, including extracellular domains of cell surface receptors and intracellular portions that may contain T-cell epitopes. Antibodies such as anti-idiotype antibodies, or fragments thereof, and synthetic peptide mimotopes, which can mimic an antigen or antigenic determinant, are also captured under the definition of antigen as used herein. Similarly, an oligonucleotide or polynucleotide that expresses an antigen or antigenic determinant in vivo, such as in gene therapy and DNA immunization applications, is also included in the definition of antigen herein. [see paragraph 85] Therefore, the viral proteins of influenza HA, NA and SARS Spike, for example, would possess epitopes capable of eliciting CD8 and CD4 T cell immune responses. Therefore, the alphavirus replicons taught by Perri et al. represented in figure 2 or those used in generating the data of Figure 20 would possessed one polynucleotide replicon encoding alphavirus nsp1-4, an antigenic peptide (full-length influenza HA or NA or SARS Spike) possessing a RBD of a viral protein, which includes the transmembrane domain of the viral protein and a CD4 T cell epitope which are also present in the viral protein and a second polynucleotide replicon encoding alphavirus nsp1-4, and a CD8+ T cell epitope, which the other viral protein encoded would possess the CD8+ T cell epitope. Furthermore, these viral proteins naturally possess signal sequences, which facilitate processing and formation inside infected cells. Perri et al. also teach vectors that comprise the alphavirus constructs/replicons. [see paragraphs 96-98]
Therefore, Perri et al. anticipate the instant invention.
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.
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(s) 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Perri et al. as applied to claims 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 13 and 16-18 above, and further in view of Gaiha et al. (US PGPub 20230302083).
The claimed invention also requires that the CD4+ T cell epitope is a Pan-DR epitope (PADRE) and that the RBD is from a SARS-CoV-2 S1 subunit.
The teachings of Perri et al. are summarized above, however, they do not teach the use of a CD4+ T cell epitope that is Pan-DR (PADRE) or the S1 subunit comprising the RBD from a SARS-CoV-2.
Gaiha et al. immunogenic compositions focused on treating SARS-CoV-2 viruses. One example is nucleic acid sequences which encode SARS-CoV-2 spike proteins, with a focus on CTL epitopes. [see paragraphs 11 and 105] Gaiha et al. also teach the use of immune-enhancer elements, such as the universal T-helper epitope pan HLA-DR (PADRE). [see paragraph 58]
It would have been obvious to one of ordinary skill in the art to modify the compositions taught by Perri et al. in order to employ immune-enhancers, such as PADRE, with their immunogenic compositions and the encode a RBD from a SARS-CoV-2. One would have been motivated to do so, given the suggestion by Perri et al. that inducing immune responses against an immunogen of interest is an important focus of their teachings. There would have been a reasonable expectation of success, given the knowledge that PADRE functions as a T-helper epitope and can aid in inducting immune responses, as taught by Gaiha et al. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim(s) 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Perri et al. as applied to claims 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 13 and 16-18 above, and further in view of Geall et al. (US PGPub 20130195969).
The claimed invention also requires that at least one polynucleotide comprises 5-methyl-cytidine, which is a modified polynucleotide.
The teachings of Perri et al. are summarized above, but they do not teach at least one polynucleotide comprises 5-methyl-cytidine, which is a modified polynucleotide
Geall et al. teach the generation of RNA based compositions that contain alphavirus sequences encoding nsp1-4 and an immunogen. [see paragraphs 23, 24 and 33] Geall et al. also teach that their delivery of nucleic acid sequences can be achieved by using vectors. [see paragraph 3] The RNA sequence can possess modified nucleobases, such as 5-methylcytidine (m5C). [see paragraph 33] Examples of the immunogen that are encoded are viral spike glycoproteins, such as that from a SARS virus or an influenza virus HA protein. [see paragraph 78] The spike protein taught would inherently possess a S1 portion, a receptor binding domain, and a transmembrane domain. Furthermore, the taught influenza HA protein would inherently possess a transmembrane domain. These virus proteins would also inherently possess CD4+ and CD8+ T cells epitopes. Geall et al. further teach that pharmaceutically acceptable carriers can be used to deliver their polynucleotides. [see paragraph 106]
It would have been obvious to one of ordinary skill in the art to modify the compositions taught by Perri et al. in order to include polynucleotides that are modified, such as 5-methyl-cytidine. One would have been motivated to do so, given the suggestion by Perri et al. the use of alphavirus replicon constructs to encode antigenic proteins of virus. There would have been a reasonable expectation of success, given the knowledge that alphavirus replicons can be designed with 5-methyl-cytidine containing nucleotides and that alphavirus replicons can also be used to express viral proteins from SARS or influenza, as taught by Geall et al. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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