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 131-135 are added and claims 74,103,131 and 133-135 are under consideration.
Claims 1-73 and 107 have been canceled.
Claims,104-105,118 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Newly submitted claim 132 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 132 lacks unity of invention because even though the inventions of these groups require the technical feature of a bridging composition that binds a cell surface receptor and an AAV particle, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Bertozzi in view of Mevel, as set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of claim 103 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn in light of the amendments to the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The rejection of claim(s) 74 and 103 under 35 U.S.C. 102a2 as being anticipated by US 11,787,865 (Bertozzi; IDS) is withdrawn as Bertozzi did not teach, specifically, AAV as a viral particle type to be used in the bridging system.
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.
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 WO2017/212019 (Mevel; IDS).
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:
PNG
media_image1.png
134
254
media_image1.png
Greyscale
Figure 1 of Bertozzi depicts a mannose 6 phosphate (M6P) polymer (Xn) that binds to the cell surface receptor M6PR (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, Mevel taught chemical coupling of an AAV particle between a capsid protein and a targeting ligand (L ) that is capable of binding a cell surface receptor, including mono- and polysaccharides (i.e. mannose, page 14), to increase the delivery of the AAV into cells. Mevel teaches that AAV are capable of transducing a wide range of post-mitotic cells for delivery of DNA of non-viral origin (transgene, claim 131) and altering the viral particle to include a cell surface binding ligand can target the AAV to particular cells (page 28) for nucleic acid delivery (page 29). Mevel also teaches that altering the viral surface can reduce the binding of antibodies that mediate viral clearance, further enhancing nucleic acid deliver y to cells. Mevel teaches that by addition of a ligand to the protein capsid of AAV particles, greater therapeutic benefit is realized at lower effective dosages which prevent immune toxicity associated with AAV-mediated gene therapy (page 30).
Thus, it would have been obvious at the time of filing to use AAV as the viral particle 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
PNG
media_image1.png
134
254
media_image1.png
Greyscale
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 as Mevel taught targeting the AAV particle to a cell surface receptor, via a cell-surface ligand, led to increased delivery efficiency at lower, less toxic doses. 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. The newly added claims 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 VALARIE BERTOGLIO whose telephone number is (571)272-0725. The examiner can normally be reached M-F 6AM-2:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
Prosecution Insights