DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to an amendment filed 3/24/2026.
Claims 29-31 are pending.
This application claims priority as a 371 filing of PCT/US2020/055100 filed 10/9/2020 which claims priority to U.S. provisional application 62/913,111 filed 10/9/2019.
Response to Amendments
Applicants have cancelled all non-elected claims.
The replacement drawings have corrected a majority of the objections. However, a single figure is still not clearly visible. The amendment to the disclosure is sufficient to overcome the objections to the sequence compliance.
Drawings
The drawings are objected to because Figure 11A, F, text is fuzzy and not discernible. A proposed drawing correction or corrected drawings are required in reply to the Office action to avoid abandonment of the application. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 26, 27, 28 and 31 are objected to because of the following informalities: claim 31 uses abbreviations NIS that is not spelled out. Although claims are allowed abbreviations, if an abbreviation is not spelled out upon first use in a claim, MPEP §2429 states that Applicant only use abbreviations that are specifically defined in "WIPO Standard ST.25 (1998)" or that are well known and would be clear to someone who had not read the invention description. This objection is maintained and applicants have not addressed it through amendment or argument.
Appropriate correction is required.
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 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.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Sakai et al (JVi, 2013, pages 1105-1114) in view of Ayala-Breton (Molecular Therapy, 2013, pages 1930-1937) in IDS filed 7/26/2022. This rejection is maintained.
Sakai et al teaches a VSV virus comprising CDV F and H but deleted of VSV G. As this virus comprises genes necessary for replication, it would be replication competent.
A VSV pseudotype bearing the H protein and the F protein of the CDV strain on the surface of the virion (referred to as VSVDG*-F-dVH) was constructed.
The detail as to how these are generated are not shown. However, Ayala-Breton teaches the construction of vectors that comprise templates for coding for the VSV genes absent VSV G and F and H glycoprotein (Figure 1). These are then used to produce VSV (see page 1936, col 1).
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Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made that the nucleic acid of Ayala-Breton is applicable to the similar system of Sakai et al. Such a modification would have resulted in the virus of claim 26. As noted above: 1) VSV pseudotyped with CDV F and H are known in the art wherein the VSVG gene is deleted and 2) Ayala-Breton teaches constructs for producing such virus are shown to comprise genes encoding all of the components. Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the expanded method would allow improved treatment.
Claims 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Sakai et al (JVi, 2013, pages 1105-1114) in view of Ayala-Breton (Molecular Therapy, 2013, pages 1930-1937) as applied to claim 26 above, and further in view of Plattet et al (JVI, 2007, pages 11413-11425, IDS 11/9/2023), Msaouel (Methods Mol Biol, 2012, pages 141-162) Zipperle (J Virology, 2010, pages 9618-9624, IDS 5/6/2025) and Goel et al (Blood, 2007, pages 2342-2350, IDS 7/26/2022). This rejection is maintained.
Plattet et al teach construction of an improved F protein with an exogenous signal sequence that is from human secretory component (see figure 2 B and D). The sequence is less than 30 amino acids as known in the art.
As to the improved nature of CDV H for vaccinations, the tropism of the protein is altered by addition to scFV and modification of native binding sequence (Msaouel et al). These teachings are to the overlapping system of MV and similar modifications to binding are taught by Zipperle which teaches deletion of SLAM binding by alanine substitution of i.e. 526 (see abstract and figure 1). This is to allow altered binding.
These constructs comprising VSV and glycoproteins from MV and CDV provide the opportunity to improve oncolytic virus. MV glycoproteins which are related to those of CDV have been advanced in such uses. As shown above, these are valuable in oncolytic virus (Ayala-Breton) which are shown to be improved by altering tropism as shown above (Msaouel and Zipperle). Further improvements are found by incorporation of NIS in VSV vectors wherein the vector can be imaged and therapy (see Goel, page 2342).
Taken together, these modifications would have been prima facia obvious to a person of skill in the art as they are directed to analogous art and provide improvements that are designed to create improved constructs for therapeutic uses.
Response to Arguments
Applicants argue that one would not combine the teachings of Sakai and Ayala-Breton that is no suggestion that one would substitute CDV FH with that of MV given that Sakai is clarifying functions of F and H on viral entry and Ayala-Breton does not teach or mention CDV and instead uses MV. As to the rejection based on Plattet et al., Msaouel et al., Zipperle et al., and Goel et al. applicants argue these do not alter this argument.
This ignores the rationale behind the rejection. Sakai teaches a virus that is encoded by the claims. Sakai does not provide the encoding sequences. The point in combining the references is to show that such a construct encoding the virus of Sakai is encoded by a sequence that would read on the instant claims and this is shown by Ayala-Breton. Sakai teaches that SLAM is the receptor for CDV and this receptor is shared by MV which is a member of the same genus (page 1105, col 1). To establish this, Sakai develops a pseudotyped virus which is VSVDG further modified to express the CDV F and H proteins (see page 1107, col 1). demonstrates that expressing both F and H from CDV lead to syncytia formation and methods of entry into monkey cells were identified (page 1113, col 1). To this end, Ayala-Breton teaches what the construct that expresses this virus would look like as a VSVDG further modified to express the F and H proteins. There is no motivation that would one substitute the sequences based upon Sakai. Rather, one would know that the construct encoding VSVFH of Sakai would be that modeled after Ayala. And such a construct in a cell naturally expresses mRNA as recited in the claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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