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 .
DETAILED ACTION
Priority
This Application is a national phase application filed under 35 U.S.C. § 371 claiming priority to Application No. PCT/US22/78052, filed on October 13, 2022, which claims priority to U.S. provisional Application No. 63/255,072, filed on October 13, 2021, that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 11/08/2015 is acknowledged. Claims 1-4, 7-10, 12-17, 40-41, 46-47, 51 and 57 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/09/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawing filed on 04/12/2024 are acknowledged and accepted by the Examiner.
Claim Objections
Claims 9-10, 13-14 and 16-17 are objected to for the following informalities:
Claims 9-10, 13-14 and 16-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(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.
Claims 46-47 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163.11.A.2.(a).i) states, "Whether the specification shows that applicant was in
possession of the claimed invention is not a single, simple determination, but rather is a factual
determination reached by considering a number of factors. Factors to be considered in
determining whether there is sufficient evidence of possession include the level of skill and
knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention".
For claims drawn to a genus, MPEP § 2163 states the written description requirement
for a claimed genus may be satisfied through sufficient description of a representative number
of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant,
identifying characteristics, i.e., structure or other physical and/or chemical properties, by
functional characteristics coupled with a known or disclosed correlation between function and
structure, or by a combination of such identifying characteristics, sufficient to show the
applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at
1406. A "representative number of species" means that the species which are adequately described arerepresentative of the entire genus. Thus, when there is substantial variation within the genus, onemust describe a sufficient variety of species to reflect the variation within the genus. Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
The claims are directed to a method of treating or preventing a disease or disorder comprising administering the composition of claim 1, or a vaccine thereof, to a subject in need thereof, wherein the disease or disorder comprises an infection.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
The grounds for the written description rejection are as follows: the claims read on any disease or disorder and/or any infectious disease whereby any combinations of claimed viral regulatory protein and immunogenic polypeptides can be administered as a vaccine to prevent a disease or disorder. The claims disclose such method by producing an immunogenic composition that comprises the claimed viral regulatory protein and immunogenic polypeptides that protects a subject from said disease or disorder indicated by Applicant’s disclosure.
The teachings in the art suggest that antibody-mediated protection is not sufficient in all infectious diseases. The major contagious killers of today for which we do not yet have vaccines are restrained to some extent not only by antibodies but also by cell-mediated immunity. Thus, the applicant has not shown, otherwise, that any viral regulatory protein and immunogenic polypeptide would prevent a subject from any disease or disorder.
The Applicant only discloses of constructs utilizing SARS COV-2 spike protein in a single mRNA with a corresponding regulatory protein assembled into a lipid nanoparticle and expression of said protein (Example 1); and determining the humoral response induced by the exemplary constructs as well as the level of neutralizing antibodies from mouse serum (Example 2). The application does not support the data with such a broad claim comprising preventing any disease or disorder by administration of the claimed composition. For example, if the disease is from an HIV infection, applicant has not demonstrated that the claimed formulation can prevent the disease from said infection.
In view of the lack of disclosure of the broad interpretation of the composition, the claims are rejected as lacking adequate descriptive support for the method of preventing a disease or disorder in a subject comprising administering the composition of claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-4, 7-8, 12, 15, 40-41, 46-47, 51 and 57 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kingsman et al. “Kingsman” (US Patent 7,790,419, IDS of record dated 09/09/2025), in view of Fevrier et al. “Fevrier” (WO2010/023260, IDS of record dated 09/09/2025).
The claims are directed to a composition comprising: a first nucleic acid encoding a viral regulatory protein; and a second nucleic acid encoding an immunogenic polypeptide, wherein the immunogenic polypeptide is codon-optimized to a virus from which the viral regulatory protein is derived.
Regarding claims 1-4, 7, 12, 46-47, 51 and 57, Kingsman discloses a “viral vector production system for use in treating or preventing viral infection which system comprises: (i) a viral genome comprising at least one first nucleotide sequence encoding a gene product capable of binding to and effecting the cleavage, directly or indirectly, of a second nucleotide sequence, or transcription product thereof, encoding a viral polypeptide required for the assembly of viral particles (instant claim 1 a first nucleic acid encoding a viral regulatory protein; and second nucleic acid encoding an immunogenic polypeptide); (ii) a third nucleotide sequence encoding said viral polypeptide required for the assembly of the viral genome into viral particles, which third nucleotide sequence has a different nucleotide sequence to the second nucleotide sequence such that said third nucleotide sequence, or transcription product thereof, is resistant to cleavage directed by said gene product” (Abstract). Kingsman discloses embodiments whereby “the plasmid vector used to produce the retroviral genome within a host cell/packaging cell will also include transcriptional regulatory control sequences operably linked to the retroviral genome to direct transcription of the genome in a host cell/packaging cell. These regulatory sequences may be the natural sequences associated with the transcribed retroviral sequence, i.e. the 5′ U3 region, or they may be a heterologous promoter such as another viral promoter, for example the CMV promoter. Some retroviral genomes require additional sequences for efficient virus production. For example, in the case of HIV, rev and RRE sequence are preferably included. However, the requirement for rev and RRE can be reduced or eliminated by codon optimization” (column 7 lines 25-41) (instant claim 1, immunogenic polypeptide is codon-optimized). Moreover, Kingsman discloses “In retroviral vectors, the promoter driving expression of a therapeutic gene may be the native retroviral promoter in the 5' U3 region, or an alternative promoter engineered into the vector” and “the first nucleotide sequence will also be operably linked to a transcriptional regulatory control sequence to allow transcription of the first nucleotide sequence to occur in the target cell. The control sequence will typically be active in mammalian cells. The control sequence may, for example, be a viral promoter such as the natural viral promoter or a CMV promoter or it may be a mammalian promoter. (column 7 lines 45-58) (instant claims 1, 7, 12, 46-47 and 51), from which the viral regulatory protein is derived). Additionally, Fevrier discloses “a method of raising an immune response against a pathogen which comprises administering (i) one or more first immunogenic polypeptides derived from said pathogen; (ii) one or more viral vectors comprising one or more heterologous polynucleotides encoding one or more second immunogenic polypeptides derived from said pathogen; and (iii) an adjuvant” (Abstract). Fevrier also discloses that “suitable polypeptide antigens to be administered as polypeptide or polynucleotide encoding polypeptide according to the invention include antigens derived from HIV (eg HIV-1 ), human herpes viruses (such as gH, gl_ gM gB gC gK gE or gD or derivatives thereof or Immediate Early protein such as ICP27, ICP 47, ICP4, ICP36 from HSV1 or HSV2), cytomegalovirus, especially Human, (such as gB or derivatives thereof) (page 13, last para.) (instant claims 2-4 and 57), whereby said “immunogenic compositions suitably stimulate production of pathogen-specific CD4+ T-cells and/or CD8+ T-cells and/or antibodies” (page 4, third para.).
Accordingly, it would have been obvious to one of ordinary skill in the art to generate a composition comprising a first nucleic acid encoding a viral regulatory protein; and a second nucleic acid encoding an immunogenic polypeptide, wherein the immunogenic polypeptide is codon-optimized to a virus from which the viral regulatory protein is derived as taught by Kingsman. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success given the knowledge that Kingsman discloses embodiments whereby the immunogenic polypeptide may be codon-optimized to a virus from which the viral regulatory protein is derived (column 7, lines 25-58); and given the knowledge that Fevrier teaches codon-optimization of an immunogenic polypeptide with an immediate-early regulatory protein such as ICP27 (page 13, last para.) demonstrates the compositions stimulate production of pathogen-specific CD4+ T-cells and/or CD8+ T-cells and/or antibodies” (page 4, third para.). Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 8, Kingsman discloses a nucleotide sequence comprising overlapping reading frames coding for lentiviral gag and pol proteins wherein the reading frames encoding lentiviral gag and pol proteins are codon optimised for expression in mammalian producer cells (claims 1 and 2 of Kingsman).
Regarding claim 15, Kingsman discloses a fusion protein construct may include the first and second nucleic acid (column 12, lines 62 to column 13 lines 1-3).
Regarding claims 40 and 41, Kingsman discloses a lipid nanoparticle delivery vehicle (column 13 lines 42-51).
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
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