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 election without traverse of Group II claims 64, 67,69-74, and 76 in the reply filed on 12/12/2025 is acknowledged.
Examiner acknowledges that claim 76 was omitted from the Restriction Requirement and is included with Group II because it is dependent on claim 64.
Claims 63, 65-66, 68, 75, 77-80 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/12/2025.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP20215823.4, filed on 12/18/2020.
This application claims the benefit of priority to Patent Application PCT/EP2021/086645.
Acknowledgement is made of Applicants’ claim for benefit to prior filed to Patent Application
Number PCT/EP2021/086645, filed on 12/17/2021.
Information Disclosure Statement
The Information Disclosure Statements filed 06/01/2023, 07/15/2025, and 03/04/2026 have been considered by the Examiner.
Status of Claims
Claims 64, 67, 69-74, and 76 are under examination.
Claims 63, 65-66, 68, 75, 77-80 are withdrawn.
Claim 1-62 are cancelled.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 64, 67, 69-74, and 76 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paul et al. (WO 2017/189963 A1 which is Foreign Patent Document No.4 of the IDS submitted 06/01/2023).
Regarding claim 64, Paul et al. teach a method for delivery an antibody or antibody fragment to the CNS in a subject (page 230, paragraph 004433). Paul et al. teach delivery for the treatment of a disease or disorder of the central nervous system in a subject (pages 212 & 237, paragraphs 00376 & 00458). Paul et al. teach the vector encoding an antibody or antibody fragment delivered to the cells of the central nervous system (page 231, paragraph 00437).
Regarding claim 67, Paul et al. teach delivery of AAV particles encoding the antibody or antibody fragment to cells of the central nervous system, the parenchyma (page 233, paragraph 00446).
Regarding claim 69, Paul et al. teach the vector can target the cells of the CNS and the
AAV particles can be formulated for CNS delivery (page 212, paragraph 00376). Paul et al. teach the particles can target the cells of the brain blood barrier endothelium for transduction (page 212, paragraph 00376).
Regarding claim 70, Paul et al. teach the vector can target cells of the CNS and the AAV particles can be formulated for CNS delivery. Paul et al. teach the particles can be formulated with cell penetrating peptides that can target molecules to the brain blood barrier endothelium (page 212, paragraph 00376).
Regarding claim 71, Paul et al. teach the AAV vector could be wild-type viral vector or engineered to enable expression of antibodies or antibody fragments (page 99, paragraph 00169). Paul et al. teach the vector is selected from AAV serotype 1 (AAV1), AAV serotype 2 (AAV2), AAV serotype 8 (AAV8), AAV serotype 9 (AAV9) or AAV serotype 10 (AAV10) (page 11, paragraph 0058).
Regarding claim 72, Paul et al. teach the disease or disorder is amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD), Parkinson's disease (PD), (page 200, paragraph 00314), neurodegenerative diseases (page 200, paragraph 00315), Huntington’s disease (page 262, paragraph 00476), Brain cancers and tumors (page 263, paragraph 00481), Severe Myoclonic Epilepsy of Infancy (SMEI) (page 253, paragraph 00469), or Chronic Traumatic Encephalopathy (CTE) (page 266, paragraph 00487).
Regarding claim 73, Paul et al. teach the antibody or antibody fragment target is selected from TDP-43 (NI-205) (page 270, paragraph 00507), tau (page 308, Example 12), SNCA (synuclein alpha) (page 275, paragraph 00507), C5 (page 271, paragraph 00507), C3 (page 271, paragraph 00507), CD20 (page 271, paragraph 00507), PD-1 (page 274, paragraph 00507) or VEGF (page 276, paragraph 00508).
Regarding claim 74, Paul et al. teach the vector is administered to the subject parenterally and by intravenous infusion (page 314, claim 30).
Regarding claim 76, Paul et al. teach the promoter is selected from CMV, EF1A, CAG, CBh, GFAP, or SV40 (page 52, paragraph 00120). Paul et al. teach the enhancing element is a CMV enhancing element (page 52, paragraph 00120). Paul et al. teach the first nucleic acid contains one or more antibody heavy and light chains (page 3, paragraph 0011). Paul et al. teach the AAV particles carrying the encoded antibody sequences driven by the promoters (page 300, paragraph 00653).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Catherine L McCormick whose telephone number is (703)756-5659. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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, Tracy Vivlemore can be reached at (571) 272-2914. 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.
/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635