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 .
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.
1. Claims 1-2, 7-14, 19-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Corti (WO 2013/140247 A1) and further in view of “Examples of C-DOMAINs: Protein displays of IG-Light C-DOMAINs: Human and mouse IGL and IGK and Teleostei IGI C-DOMAINs” published by IMGT (https://www.imgt.org/IMGTrepertoire/2D-3Dstruct/SLlength/IGlight_overview.html, with Wayback Machine Publication date of 11 January 2019 having the link: https://web.archive.org/web/20190111044416/https://www.imgt.org/IMGTrepertoire/2D-3Dstruct/SLlength/IGlight_overview.html, accessed 31 December 2025, hereinafter “IMGT”), Janeway et al. (Immunobiology: The Immune System in Health and Disease. 5th edition. New York: Garland Science; 2001), Lanzavecchia, et al. (WO 2019/024979 A1, hereinafter “Lanzavecchia”), and Ravetch, et al. (WO 2020/251834 A1, hereinafter “Ravetch”).
Regarding claims 1 and 2, Corti teaches an antibody that neutralizes RSV, MPV, and PVM with the same light chain and heavy chain variable regions as the instant application, including identical CDRs in the heavy and light chain variable regions between the reference and the instant application (pg. 16 Table 2, 3210 variant 3 and Figure 24A and B).
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Corti does not teach the antibody constant regions.
However, IMGT teaches a known common human light chain constant region, which has an identical amino acid sequence to the light chain constant region of SEQ ID NO:4 in the instant application (Homosap J00253, IGLC2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Corti for an antibody with the variable light and heavy chains that neutralize RSV, MPV, and PVM with the teachings of IMGT for the constant light chain, IGLC2. Janeway provides motivation by teaching that antibodies include both a variable and constant region (3-2. Immunoglobulin heavy and light chains are composed of constant and variable regions). One of skill in the art would have had a reasonable expectation of success at combining Corti, IMGT, and Janeway because they all teach antibodies or fragments thereof.
Corti and IMGT do not teach the constant heavy chain regions.
However, Lanzavecchia teaches a heavy chain constant region including CH1, a hinge, CH2, and CH3 that has the same amino acid sequence as the instant claims, other than the M428L and N434S mutations, attached to a heavy chain variable region which binds RSV (SEQ ID NO: 70 and pg. 108 ¶2). The antibody in the reference sequence has an additional functional domain, but as the functional domain is labeled additional (Abstract), it would have been obvious for one skilled in the art to create an antibody without the additional functional domain as it is not necessary for binding RSV.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Corti, IMGT, and Janeway for the antibody light chain constant and variable regions and the heavy chain variable regions, which together bind RSV with the teachings of Lanzavecchia of a known CH1, hinge, CH2, and CH3 domain. Lanzavecchia provides motivation by teaching that a classical antibody heavy chain consists of at four domains, a variable domain, a hinge, and three heavy chain domains, CH1-CH3 (Figure 1A and pg. 1 ¶3).One of skill in the art would have had a reasonable expectation of success at combining Corti, IMGT, Janeway, and Lanzavecchia because they all teach antibodies or fragments thereof.
Corti, IMGT, and Lanzavecchia do not teach the M428L and N434S mutations in the CH3 region.
However, Ravetch teaches the M428L and N434S mutations in the CH3 region (pg. 4 ¶3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Corti, IMGT, Janeway, and Lanzavecchia for an antibody without the M428L and N434S mutations with the teachings of Ravetch for an antibody with the M428L and N434S mutations. Ravetch provides motivation by teaching that these mutations increase the half-life of the antibody (pg. 4 ¶3). One of skill in the art would have had a reasonable expectation of success at combining Corti, IMGT, Janeway, Lanzavecchia, and Ravetch because they all teach antibodies or fragments thereof.
Accordingly, SEQ ID NO: 1, the heavy chain, is rendered obvious over Corti (heavy chain variable region that binds RSV), Lanzavecchia (heavy chain constant regions), and Ravetch (stability mutations in CH3) and SEQ ID NO: 4, the light chain, is rendered obvious over Corti (light chain variable region that binds RSV) and IMGT (light chain constant region).
Accordingly, the antibody claimed in claims 1 and 2 of the instant application is prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Regarding claim 7, Corti teaches a polynucleotide that encodes an antibody (pg. 7 ¶3).
Regarding claim 8, Corti teaches that the polynucleotide may be DNA (pg. 25 ¶4).
Regarding claim 9, Corti teaches that a vector can comprise a polynucleotide that encodes an antibody (pg. 7 ¶3).
Regarding claim 10, Corti teaches a cell that expresses a polynucleotide encoding an antibody (pg. 25 ¶4).
Regarding claim 11, Corti teaches a pharmaceutical composition comprising an antibody and a pharmaceutically acceptable carrier (pg. 7 ¶3).
Regarding claims 12 and 14, Corti teaches a method of preventing RSV or MPV infection in a subject by administering a therapeutically effective amount of a pharmaceutical composition (pg. 37 ¶7 and pg. 33 ¶7).
Regarding claims 13 and 23, Corti teaches a method of treating RSV or MPV infection in a subject by administering a therapeutically effective amount of a pharmaceutical composition (pg. 37 ¶7 and pg. 33 ¶7).
Regarding claim 19, Corti teaches a method of producing antibodies using hybridomas, immortalized B cells, or plasma cells (pg. 24 ¶3-5).
Regarding claim 20, Corti teaches purifying the antibodies (pg. 24 ¶6).
Regarding claim 21, Corti teaches wherein the polynucleotide that encodes the antibody is mRNA (pg. 27 ¶3).
Accordingly, the claimed inventions were prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
2. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Corti, IMGT, Janeway, Lanzavecchia, and Ravetch as applied to claims 1-2, 7-14, 19-21, and 23 above, and further in view of Zhang, et al. (Frontiers in Immunology, March 2019, Volume 10, Article 594, hereinafter “Zhang”).
As discussed above, claims 1-2, 7-14, 19-21, and 23 were rendered prima facie obvious by the teachings of Corti, IMGT, Janeway, Lanzavecchia, and Ravetch.
Regarding claim 22, Corti, IMGT, Janeway, Lanzavecchia, and Ravetch do not teach that the mRNA comprises a modified nucleoside. However, Zhang teaches sequence optimization and the usage of modified nucleosides including pseudouridine, 5-methylcytidine, and cap-1 structure (pg. 4 column 1 ¶1, Engineered mRNA with Potent Efficiency).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Corti, IMGT, Janeway, Lanzavecchia, and Ravetch for an antibody encoded by mRNA with the teachings of Zhang for modified nucleosides. Zhang provides motivation by teaching that modified nucleosides improve translation (pg. 4 column 1 ¶1). One of skill in the art would have had a reasonable expectation of success at combining Corti, IMGT, Lanzavecchia, Ravetch, and Zhang because they all teach antibodies or fragments thereof.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672