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
1. Claims 1-9, 11-15, 17-21, 23 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 6/25/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
3. The disclosure is objected to because of the following informalities:
The use of trademarked terms has been noted in this application on p. 57. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
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.
4. Claim 23 is 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 inducing immune response and risk reduction, does not reasonably provide enablement for treating or preventing henipavirus infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
See claim 23 as submitted 6/25/2024.
In making a determination as to whether an application has met the requirements forenablement under 35 U.S.C. 112 P 1, the courts have put forth a series of factors. See, In reWands, 8 USPQ2d 1400, at 1404 (CAFC 1988). The factors considered include (1) the quantityof experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6)the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) thebreadth of the claims. Id. While it is not essential that every factor be examined in detail, thosefactors deemed most relevant should be considered. In the present case, the factors deemedrelevant are those of: the breadth of the claims; the (un)predictability of the art; the amount of direction and the working examples provided, and the quantity of experimentation necessary.
Breadth of the claims: Claim 23 recites a method of treating, reducing the risk of, or preventing henipavirus infection in a subject in need thereof, comprising administering to the subject an effective amount of the vaccine composition of claim 18. Thus, the present claim broadly reads on prevention or prophylaxis as well as therapeutically effective treatments of henipavirus infection.
State of the art: The prior art teaches mixed results for immunization for Nipah and Hendra virus infections, with much work still to be done. For example, Amaya et al. (“Vaccines to Emerging Viruses: Nipah and Hendra,” Annu Rev Virol. 29; 7(1): 447-473 (2020))(See PTO-892: Notice of References Cited) teaches: wherein development of effective vaccines against HeV and NiV has been a research focus (abstract); wherein vaccine approaches designed to induce adequate neutralizing antibody response to NiV and HeV should be effective (p. 6); ALVAC-HeV-F and ALVAC-HeV-G vaccination studies showed that these vectors did not provide 100% protection in hamsters challenged with HeV (p. 11); a single subunit vaccine may be effective against both NiV and HeV (p. 11); over the past 15 years, nearly a dozen NiV and HeV vaccine approaches have been trialed in animal challenge models, and many show promise (p. 14). Further, Mohammed et al. (“Epitope-Based Peptide Vaccine against Glycoprotein G of Nipah Henipavirus Using Immunoinformatics Approaches,” Journal of Immunology Research, Article ID 2567957: 1-12 (2020))(See PTO-892: Notice of References Cited) teaches: there are no antiviral drugs available for NiV disease and the treatment is just supportive (abstract).
The amount of direction and the working examples provided: The present specification discloses: F and G sequences (Table 3)); chimera construction (Example 1); antibody neutralization tests (Example 4); monoclonal antibodies (Table 7).
In view of the lack of support in the specification and the prior art and the breadth of the claims, the skilled artisan would be required to conduct undue amount of experimentation inorder to use the instantly claimed Cedar virus chimeras for prevention or treatment of henipavirus infection. While the art and specification support elicitation of antibody immune response to Nipah and Hendra virus infection, the teachings in the specification do not appear to sufficiently bridge the gap and enable the full scope of the instant claim also drawn towards therapeutic treatment methods and prophylaxis.
Thus, as discussed above undue experimentation would be required to practice the claimed invention commensurate with the scope of the claims. Reasonable correlation must exist between the scope of the claims and scope of enablement set forth. In view of the quantity ofexperimentation necessary, the limited working examples, the unpredictability of the art, the lackof sufficient guidance in specification, and the breadth of the claims, it would take undue trialsand errors to practice the claimed invention.
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.
5. Claims 1, 2, 4, 5, 8, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Laing et al. (“Rescue and characterization of recombinant cedar virus, a non-pathogenic Henipavirus species,” Virology Journal, Vol. 15: 56 (1-12))(2018))(cited in applicant’s IDS submitted 6/25/2024) in view of Doyle et al. (“Functional cooperativity mediated by rationally selected combinations of human monoclonal antibodies targeting the henipavirus receptor binding protein,” bioRxiv: 1-46 (2021))(cited in applicant’s IDS submitted 6/25/2024).
See claims 1, 2, 4, 5, 8, 9 as submitted 6/25/2024.
Laing et al. teaches: replication competent Cedar virus variants (abstract); including recombinant Cedar virus that expresses GFP from ORF (abstract); including rCEdPV used as platform for henipavirus therapeutics (p. 9).
Laing et al. does not teach: chimera wherein one or both of the F and G envelope glycoprotein genes of CedV are replaced with one or both of the F and G envelope glycoprotein genes, respectively, of a non-CedV henipavirus.
Doyle et al. teaches: Cedar virus chimerized to display the HeV or NiV RBP and F surface glycoproteins (p. 7)(as recited in claims 1, 2, 4, 5); as well as GFP (p. 15)(as recited in claims 8, 9); for use in eliciting antibody response (p. 20).
One of ordinary skill in the art would have been motivated to use Cedar virus variant as taught by Doyle et al. with the composition as taught by Laing et al. Laing et al. teaches recombinant Cedar virus constructs and use in possible therapeutics, and Doyle et al., which also teaches use of recombinant Cedar virus constructs, teaches such a recombinant Cedar virus construct including for use in eliciting antibody response (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using Cedar virus variant as taught by Doyle et al. with the composition as taught by Laing et al. There would have been a reasonable expectation of success given the underlying materials (Cedar virus variants as taught by Laing et al. and Doyle et al.) and methods (eliciting immune response using Cedar virus variants as taught by Laing et al. and Doyle et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
6. Claims 3, 6, 7, 18, 19, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Laing et al. in view of Doyle et al. as applied to claims 1, 2, 4, 5, 8, 9 above, and further in view of Stewart-Jones et al. (WO2020028902A1)(See PTO-892: Notice of References Cited).
See claims 3, 6, 7, 18, 19, 23 as submitted 6/25/2024.
See also the 35 U.S.C. 112(a) rejection above.
See the teachings of Laing et al. in view of Doyle et al. above.
Laing et al. in view of Doyle et al. does not teach; Malaysian strain; Bangladeshi strain; adjuvant.
Stewart-Jones et al. teaches: Nipah virus immunogens (abstract); nucleic acids encoding the immunogens (abstract); including F ectodomain trimers; G ectodomains (abstract); including from Malaysian strains and Bangladeshi strains (p. 16); adjuvant (p. 19); including soluble immunogen (p. 2); wherein F protein is envelope glycoprotein of NiV (p. 16); wherein G glycoprotein is an envelope glycoprotein (p. 16); wherein henipavirus is also Hendra virus (p. 30); formulated with carrier (p. 47); administering to subject as part of vaccination (p. 45)(as recited in claims 18, 23).
One of ordinary skill in the art would have been motivated to use components as taught by Stewart Jones et al. with the composition as taught by Laing et al. in view of Doyle et al. Laing et al. in view of Doyle et al. teaches eliciting immune response, development of therapeutics and use of F and G domains of Nipah or Hendra virus, and Stewart Jones et al., which also teaches eliciting immune response and use of F and G domains of Nipah or Hendra virus, teaches known strains of Nipah virus and Hendra viruses and the advantage of using adjuvant with vaccine compositions (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using components as taught by Stewart Jones et al. with the composition as taught by Laing et al. in view of Doyle et al. There would have been a reasonable expectation of success given the underlying materials (F and G domains as taught by Stewart Jones et al. and Laing et al. in view of Doyle et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
7. Claims 20, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Laing et al. in view of Doyle et al. and further in view of Stewart Jones et al. as applied to claims 3, 6, 7, 18, 19, 23 above, and further in view of Elhay et al. (WO2012158643A1)(See PTO-892; Notice of References Cited).
See claims 20, 21 as submitted 6/25/2024.
See the teachings of Laing et al. in view of Doyle et al. and further in view of Stewart Jones et al. above. See also the teachings of Stewart Jones et al. above, including as to: including soluble immunogen (p. 2); wherein F protein is envelope glycoprotein of NiV (p. 16).
Laing et al. in view of Doyle et al. and further in view of Stewart Jones et al. does not teach: further comprising (ii) a soluble G envelope glycoprotein (sG) of a non-CedV henipavirus; wherein the non-CedV henipavirus sG and sF comprise NiV sG and sF or HeV sG and sF.
See also the teachings of Stewart Jones et al. above, including as to: soluble immunogen (p. 2); wherein F protein is envelope glycoprotein of NiV (p. 16).
Elhay et al. also teaches: immunogenic compositions comprising G glycoprotein from Hendra virus and/or Nipah virus (p. 1).
One of ordinary skill in the art would have been motivated to combine immunogens as taught by Elhay et al. with the composition as taught by Laing et al. in view of Doyle et al. and further in view of Stewart Jones et al. Laing et al. in view of Doyle et al. and further in view of Stewart Jones et al. teaches eliciting immune response against HeV or NiV, and Elhay et al. also teaches eliciting immune response against HeV or NiV (See MPEP 2144.06: Art Recognized Equivalence for the Same Purpose: I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)).
One of ordinary skill in the art would have had a reasonable expectation of success for combining immunogens as taught by Elhay et al. with the composition as taught by Laing et al. in view of Doyle et al. and further in view of Stewart Jones et al. There would have been a reasonable expectation of success given the underlying materials and methods (eliciting immune response against NiV or HeV as taught by Elhay et al. and Laing et al. in view of Doyle et al. and further in view of Stewart Jones et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
8. Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tripodi et al. (US20210115472)(See PTO-892: Notice of References Cited) in view of Wang et al. (WO2014008263A2)(See PTO-892: Notice of References Cited), Stewart-Jones et al. (WO2020028902A1)(cited above), and Elhay et al. (WO2012158643A1)(cited above).
See claims 11-13 as submitted 6/25/2024.
Tripodi et al. teaches: virus vectors. including replication competent forms (abstract)(as recited in claim 11); including one or more heterologous genes [0055]; including use of Cedar virus (Table 1).
Tripodi et al. does not teach: wherein said Cedar virus comprises F and G envelope glycoprotein genes of CedV; further comprising a coding sequence for one or both of (i) a soluble F envelope glycoprotein (sF) of a non-CedV henipavirus, (ii) a soluble G envelope glycoprotein (sG) of a non-CedV henipavirus.
Wang et al. teaches Cedar virus (abstract); including wherein the genomic sequence of the virus includes F and G proteins [0030](as recited in claim 11).
See the teachings of Stewart Jones et al. above; including as to genes or coding regions of F of Nipah virus (non-CedV)(as recited in claims 11, 12).
See the teachings of Elhay et al. above, including as to genes or coding regions of G of Nipah and/or Hendra (non-CedV)(as recited in claims 11, 12, 13).
One of ordinary skill in the art would have been motivated to use virus of Wang et al. and genes of Stewart Jones et al. and Elhay et al. in the vector of Tripodi et al. Tripodi et al. teaches use of virus vectors comprising heterologous genes as well as use of Cedar virus, and Wang et al. and Stewart Jones et al. and Elhay et al. also teach such viruses and genes (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using virus of Wang et al. and genes of Stewart Jones et al. and Elhay et al. in the vector of Tripodi et al. There would have been a reasonable expectation of success given the underlying materials (virus vectors and coding regions as taught by Tripodi et al., Wang et al., Stewart Jones et al. and Elhay et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
9. Claims 14, 15, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Tripodi et al. (US20210115472)(cited above) in view of Wang et al. (WO2014008263A2)(cited above) and Stewart-Jones et al. (WO2020028902A1)(cited above).
See claims 14, 15, 17 as submitted 6/25/2024.
Tripodi et al. teaches: virus vectors. including replication competent forms (abstract)(as recited in claim 14); including one or more heterologous genes [0055]; including use of Cedar virus (Table 1).
Tripodi et al. does not teach: wherein said Cedar virus comprises F and G envelope glycoprotein genes of CedV; comprising one or both of (i) a gene encoding a henipavirus F envelope protein fusion protein, and (ii) a gene encoding a henipavirus G envelope protein fusion protein, wherein the fusion protein comprises the ectodomain and transmembrane domain of a non-CedV henipavirus F envelope protein or G envelope protein, respectively, fused to the cytoplasmic tail domain of CedV F envelope protein or G envelope protein, respectively, or the fusion protein comprises the ectodomain of a non-CedV henipavirus F envelope protein or G envelope protein, respectively, fused to the transmembrane domain and cytoplasmic tail domain of CedV F envelope protein or G envelope protein, respectively.
Wang et al. teaches Cedar virus (abstract); including wherein the genomic sequence of the virus includes F and G proteins [0030](as recited in claim 14).
See the teachings of Stewart Jones et al. above; including as to genes or coding regions of F of Nipah virus (non-CedV)(as recited in claim 15); strains (as recited in claim 17). Stewart Jones et al. also teaches or suggests: linking NiV F ectodomain to another molecule (p. 29); wherein F ectodomain trimer can be a membrane anchored protein complex for use in an attenuated virus; wherein membrane anchoring can be accomplished by linkage of the protomers of NiV F ectodomain trimer to a transmembrane domain and optionally a cytoplasmic tail (p. 29)(reading on fusion protein comprising ectodomain of non-CedV henipavirus F envelope protein fused to transmembrane domain and cytoplasmic tail domain of CedV F envelope protein or G envelope protein as recited in claim 14; F and G proteins of Cedar virus are already taught by Wang et al. as indicated above).
One of ordinary skill in the art would have been motivated to use virus of Wang et al. and genes of Stewart Jones et al. in the vector of Tripodi et al. Tripodi et al. teaches use of virus vectors comprising heterologous genes, and Wang et al. and Stewart Jones et al. also teach such viruses and genes (See MPEP 2144.06: Substituting equivalents known for the same purpose). Further, one of ordinary skill in the art would have been motivated to fuse NiV F ectodomain trimer of Stewart Jones et al. to transmembrane domain and cytoplasmic tail domain of CedV F envelope or G envelope protein of Wang et al. and Tripodi et al. because Stewart Jones et al. already suggests and teaches the advantage of a membrane anchored protein complex for use in an attenuated virus or virus like particle vaccine.
One of ordinary skill in the art would have had a reasonable expectation of success for using virus of Wang et al. and genes of Stewart Jones et al. in the vector of Tripodi et al. There would have been a reasonable expectation of success given the underlying materials (virus vectors and coding regions as taught by Tripodi et al., Wang et al., and Stewart Jones et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672