METHOD OF PRODUCING ADENO-ASSOCIATED VIRUS

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 . DETAILED ACTION Claims 1-6, 8-10 are under consideration. Priority 2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Since a certified English translation has not been provided for JAPAN 2022-054065, until foreign priority is perfected, the effective filing date for the purposes of applying prior art is 3/29/2022. Information Disclosure Statement 3. The information disclosure statements (IDS) were submitted on 8/26/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Specification 4. The disclosure is objected to because of the following informalities: The use of trademarked terms, has been noted in this application on pages 52, 55, 73, among possibly others. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. 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 (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 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. 5. Claims 1-6, 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fiedler et al. (WO2020264411A1)(cited in applicant’s IDS submitted 8/26/2024). See claims 1-6, 8-10 as submitted 8/26/2024. Fiedler et al. teaches: producing AAV product (abstract)(as recited in claim 1); wherein AAV is loaded onto affinity resin and eluted from resin using buffer (abstract); wherein wash buffer includes single amino acid or combination of two or more amino acids [0092]; wherein pH of elution buffer can be 6 to 8.8 [0118](as recited in claims 1, 4, 5, 6, 8, 9, 10)(See MPEP 2144.05: I. OVERLAPPING, APPROACHING, AND SIMILAR RANGES, AMOUNTS, AND PROPORTIONS: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)); including glycine (aliphatic amino acid)[0092](as recited in claims 2, 3); histidine [0028]; use of adjuster [00269](as recited in claim 4); using antibody [0073](as recited in claims 8, 9, 10). In view of such teachings or suggestions, the embodiment as recited in claims 1-6, 8-10 is considered an obvious embodiment in view of Fiedler et al. In view of the foregoing, all the claimed limitations are found in one reference and are taught to be optional variations to a ‘base’ method they exemplify. As such, the claimed embodiment is within the scope of Fiedler et al., and thus Fiedler et al. renders the method prima facie obvious. The rationale to support this conclusion of obviousness is that Fiedler et al. provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art. 6. Claims 1-6, 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (“Scalable Single-Step Affinity Purification of rAAV Vector Using AVB-Sepharose Yields High Purity and High Titer Vector,” Molecular Therapy, Vol. 20, Supplemental 1 (2012))(cited in applicant’s IDS submitted 8/26/2024). See claims 1-6, 8-10 as submitted 8/26/2024. Zhao et al. teaches: purifying AAV vector (p. s230)(as recited in claims 1, 5); using Sepharose resin with antibody that binds to AAV capsid (p. s230)(as recited in claims 1, 5, 6, 8, 9, 10); eluting with buffers at pH 3.0 (p.s230)(as recited in claims 1, 4, 5, 6, 8, 9, 10)(See MPEP 2144.05: I. OVERLAPPING, APPROACHING, AND SIMILAR RANGES, AMOUNTS, AND PROPORTIONS: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)); using glycine (aliphatic amino acid)(as recited in claims 2, 3, 5, 6); additional buffers (as recited in claim 4). In view of such teachings or suggestions, the embodiment as recited in claims 1-6, 8-10 is considered an obvious embodiment in view of Zhao et al. In view of the foregoing, all the claimed limitations are found in one reference and are taught to be optional variations to a ‘base’ method they exemplify. As such, the claimed embodiment is within the scope of Zhao et al., and thus Zhao et al. renders the method prima facie obvious. The rationale to support this conclusion of obviousness is that Zhao et al. provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art. Conclusion 7. With respect to 35 U.S.C. 112(a), it is noted that the specification teaches use of: glycine, alanine, isoleucine, leucine for purification (p. 8); glutamic acid (p. 8, Example 4); isoleucine (p. 57, Example 15); threonine (Example 17); aspartic acid (Example 18); arginine (Example 19); histidine (p. 78). 8. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00. 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, Thomas Visone can be reached at 571-270-0684. 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. /M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672