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 .
Remark
The appeal Brief filed by Applicants have been noticed. Appeal conference had been made with two Supervisory examiners. After further considering the pending claims, an reopen the prosecution has been reopened thereafter.
Status of the Claims
Claims 1-4, 10-12, 14-15, 17-24 are pending.
Claims 1-3, 10-12, 14-15 and 23-24 read on the elected species (A) Paramyxoviridae, (C) the antigenome of RSV of SEQ ID NO: 7; and (D) Avulavirus of the family Paramyxoviridae are considered based on the election without traverse made by Applicants on. Jan 16, 2024.
Claims 4 and 17-22 that are not read on the elected species are withdrawn from consideration.
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.
Claims 10 and 23-24 still 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In the instant case, the specification as it was originally filed does not support that the claimed subject matter drawn to “A recombinant respiratory syncytial virus (RSV) expression vector, comprising a gene encoding the fusion protein (F protein) selected from a heterologous virus consisting of measles virus and Newcastle disease virus that is substituted for a gene encoding the F protein of RSV .”
In the response, Applicants traverse the rejection and submitted the supports of the amendment was discussed in the interview and specification , wherein the heterologous F protein selected of measles virus and Newcastle disease is to replace the endogenous F protein of the RSV. The support of this disclosure can be found in the specification on pages 18-20.
Applicants’ argument has been respectfully considered including the specification on pages 18-20 has been carefully reviewed , it is found what the argument is not what the claim 10 is cited. Specification on page 18-20 regarding the F protein substitution issues are all described that “Measles virus (MV) and Newcastle disease virus (NDV) were selected as F protein donors. After cleaving the backbone construct A with MluI and ApaI restriction enzymes, the designed measles virus F gene was inserted. After cleaving the backbone construct A with the MluI restriction enzyme, the designed Newcastle disease virus F gene was inserted.”
However, claim 10 after the amendment filed on May 12, 2025, it reads as “A recombinant respiratory syncytial virus (RSV) expression vector, comprising a gene encoding the fusion protein (F protein) selected from a heterologous virus consisting of measles virus and Newcastle disease virus that is substituted for a gene encoding the F protein of RSV .”
Applicants are required to amend claim 10 in order to overcome the rejection.
However, claim 10 claims 23-24 are also listed as a potentially rejected too based on Applicants’ argument by the Applicants during the interview (9/23/2025)..
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.
The rejection of Claims 1-3, 14-15 and 23-24 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by US Patent No. 7,662,397B2 (397B2) or US Patent No. 7,744,902 B2 )902B2) or US 6923971B2 all to Krempl et al. are moot in view of a new ground of the rejection.
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.
Claims 1-2, 10, 12, 14-15 and 23 rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 7,662,397B2 (397B2).
The claimed invention is draw to a recombinant respiratory syncytial virus (RSV) in which genes encoding the envelope proteins of RSV are rearranged, wherein
Krempl et al. teach an infectious recombinant respiratory syncytial virus (RSV) comprising a major nucleocapsid (N) protein, a nucleocapsid phosphoprotein (P), a large polymerase protein (L), a M2(ORF1) RNA polymerase elongation factor, and a partial or complete recombinant RSV genome or antigenome having one or more shifted RSV gene(s) or genome segment(s) within said recombinant genome or antigenome that is/are positionally shifted to a more promoter-proximal or promoter-distal position relative to a position of said RSV gene(s) or genome segment(s) within a wild type RSV genome or antigenome, wherein the recombinant genome or antigenome comprises a partial or complete RSV vector genome or antigenome combined with one or more heterologous genes or genome segments encoding one or more antigenic determinants of one or more heterologous pathogens (Claim 25), wherein said one or more heterologous antigenic determinant(s) is/are selected from measles virus HA and F proteins (Claim 32), More specifically , wherein the heterologous pathogen is measles virus and the heterologous antigenic determinant(s) is/are selected from the measles virus HA and F proteins and antigenic domains, fragments and epitopes thereof. (claim 33 and Columns 30-31), the cited reference also describe that In certain aspects of the invention, the gene position-shifted RSV features one or more shifted genes or genome segments that are shifted to a more promoter-proximal or promoter-distal position by insertion, deletion, or rearrangement of one or more displacement polynucleotides within the partial or complete recombinant RSV genome or antigenome. The displacement polynucleotides may comprise an RSV gene or genome segment, including an RSV gene or genome segment from a different or “heterologous” RSV (e.g., in the case of a heterologous gene or genome segment inserted into genome or antigenome of a different RSV). Alternatively, the displacement polynucleotides may be from a non-RSV source, including from a non-RSV pathogen such as parainfluenza virus (PIV) or measles virus. The displacement polynucleotides may encode a protein or a portion of a protein, such an immunogenic domain or epitope of a glycoprotein, or they may represent an incomplete or impaired coding sequence, including non-coding and nonsense polynucleotide sequences.
Still further, the cited reference also teach that “The compositions may contain pharmaceutically acceptable auxiliary substances as required to approximate physiological conditions, such as pH adjusting and buffering agents, tonicity adjusting agents, wetting agents and the like, for example, sodium acetate, sodium lactate, sodium chloride, potassium chloride, calcium chloride, sorbitan monolaurate, triethanolamine oleate, and the like. Acceptable adjuvants include incomplete Freund's adjuvant, aluminum phosphate, aluminum hydroxide, or alum, which are materials well known in the art. Preferred adjuvants also include Stimulon® QS-21” (See column 57, last paragraph on the left).
Regarding the construction of the RSV expression vector, the cited also teaches that an RSV expression vector comprising 7 RNA polymerase, a flanking ribozyme and tandem T7 transcriptional terminators, hammerhead type ribozyme from hepatitis delta virus (Please see the columns 52-54 at the section of Description of the specific embodiments).
Based on the description above, the disclosure by the cited reference does not the F protein substitution is only partial rather than a completely replacement.
While the cited reference does not prove the example to replace the entire F protein with the heterologous F protein from measles virus (MV), the example III of the instant Application clearly teaches that an infectious rBRSV/HRSV chimera in which the entire gene of HRSV G and F genes are substituted into a recombinant bovine RSV (rBRSV) background. The resulting human-bovine chimera contains two genes of HRSV, namely G and F, and eight genes from BRSV, namely NS1, NS2, N, P, M, SH, M2 and L. Additional detail describing a human-bovine RSV construct having the human G and F genes substituted at their corresponding, wild type positions in a bovine RSV background .
Therefore, it would have been obviously for any person with an ordinarily skilled in the art to be motivated for using the F protein from MV o substitute the endogenous F protein of the RSV successfully. Because the example III clearly teaches the replacement of the endogenous F protein with a heterologous F protein from other paramyxoviruses virus does not damage the ability of RSV to become viable and active recombinant RSV expression vector.
As there are no unexpected results have been provided, hence the claimed invention as a whole is prima facie obvious absence unexpected results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAO Q LI whose telephone number is (571)272-0904. The examiner can normally be reached M-F 8 am to 8 pm EST.
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1671
In view of the appeal brief on 12/21/2025, PROSECUTION IS HEREBY REOPENED. A new ground of rejection set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671