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 .
Applicant’s reply dated 06/03/2026 has been received.
Election/Restrictions
Applicant’s election without traverse of Group V, claims 74 and 103, in the reply filed on 2/9/2016 is acknowledged.
Claims 1-73 and 107 have been canceled.
Claims 104-105,118 and 132 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/9/26.
Claims 74,103,131 and 133-135 are under consideration.
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 rejection of claim(s) 74, 103,131,133-135 under 35 U.S.C. 103 as being unpatentable over 11,787,865 (Bertozzi; IDS) in view of WO2017/212019 (Mevel; IDS) is withdrawn.
The bridging compound of Bertozzi would not have been obvious to use with the AAV delivery method of Mevel because the Bertozzi bridging compound targets viral particles and other extracellular molecules for lysosomal degradation and the AAV vector of Mevel is modified to increase uptake and gene delivery. Thus, the two references are non-analogous art. See Remarks, 09/23/2026, page 5, para 4).
Claim(s) 74, 103,131,133-135 is/are rejected under 35 U.S.C. 103 as being unpatentable over 11,787,865 (Bertozzi; IDS) in view of Mingozzi (ScienceTranslationalMedicine, 17 July 2013 Vol 5 Issue 194 194ra92, 9 pages).
Claim 74 is drawn to a bridging composition comprising a binding moiety that is capable of binding to an AAV particle and a cell surface binding moiety that binds a cell surface receptor. Claim 103 further defines the bridging composition as
[Xn–L–Z–]m–P
where X is the cell surface binding moiety, L is an optional linker, Z is a residual moiety resulting from the attachment to P and P is the moiety that binds a virus composition.
Bertozzi teaches the following:
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134
254
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Figure 1 of Bertozzi depicts a mannose 6 phosphate (M6P) polymer (Xn) that binds to the cell surface receptor M6PR, targeting the complex to the lysosomes, (claim 133,135 internalizing receptor, claim 134) which is chemically conjugated (resulting in residue Z) to an antibody (P) that binds a viral composition. Bertozzi teaches generically that the first moiety (antibody in this case) binds an extracellular molecule (col. 8, lines 29-30) and the extracellular molecule can be a whole virus (col. 8, line 32). Schemes for synthesizing chemical bonds with Xn and P are set forth in the figures, e.g. Figs 2-7.
Bertozzi does not teach that the virus particle is AAV. However, Mingozzi teaches a need for clearance of AAV particles in gene therapy. Mingozzi teaches empty capsid titration of neutralizing antibodies (Nabs) when carrying out AAV-mediated gene therapy. Mengozzi teaches that Nabs recognize the gene therapy vector and that co-administration of the therapeutic vector alon with empty vector, can remove the Nabs which allows for lower effective doses of therapeutic vector. One caveat , Mingozzi teaches, is an increase in total capsid antigen being presented on MHC class I, which contributes to the recognition of transduced cells.
Thus, it would have been obvious at the time of filing to use AAV as the viral particle recognized by the antibody in the bridging compound of Bertozzi to arrive at the invention as claimed. Bertozzi taught targeting viral particles to the surface of cells using the bridging compound
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134
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where the target (black rectangle) is a viral particle, an antibody to the viral particle is P, and mannose-6P is the ligand Xn in the claimed [Xn–L–Z–]m–P. One would have been motivated to use AAV as the viral particle and target it for degradation as Mingozzi taught the high total number of viral particles in gene therapy combined with empty capsid in empty capsid titration of Nabs can lead to increased presentation of AAV antigens by MHCI and Bertozzi teaches that the brdigin compound targets bound substrates for lysosomal degradation. One would have had a reasonable expectation of success as the chemical coupling schemes of Bertozzi could be readily applied to the AAV viral capsid as the structure of the proteins and their sequences were well known.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 74 and 103 remain and newly added claims 131,133-135 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 96 of copending Application No. 18/012,838 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the bridging composition specifically claimed in instant claim 103 is part of the viral composition of reference claim 96. Reference claim 96 has a virus particle attached, which is not required by the instant claim 103. This also renders obvious instant claim 74, which is generic to the structure of Formula I recited in instant claim 103 and reference claim 96. Formula I, [Xn–L–Z–]m–P, is recited in instant claim 103 and reference claim 96. Claims 131 amd 133-135 recite the same dependent limitations as claims 123-125 of ‘838.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant has requested this rejection be held in abeyance.
Conclusion
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
