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 .
1. Original claims 1-24 are pending and under examination.
Claim Objections
2. Claim 9 is objected to because of the recitation “the sCD59 protein comprises at least one mutation resulting in loss of function of glycosylphosphatidylinositol (GPI) anchoring domain”. Correction to “the sCD59 protein comprises at least one mutation resulting in the loss of function of the glycosylphosphatidylinositol (GPI) attachment signal” is required.
3. Claim 19 is objected to because of the recitation “or a source of expression of a human sCD59 protein”. Since the nucleic acid encoding the human sCD59 protein is the source, correction to delete this recitation from the claim is required.
Claim Rejections - 35 USC § 102
4. 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.
(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.
5. Claims 1-7, 9-14, and 19-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hou et al. (J. VitreoRetinal Dis., 2019, 3: 366-377), as evidenced by both Cashman et al. (PLoS ONE, 2011, 6: 1-9; cited on the IDS filed on 11/11/2025) and Park et al. (Frontiers in Immunology, 2019, 10:1-14).
Hou et al. disclose the clinical trial NCT03144999 for treating AMD with geographic atrophy (GA) (a complement disorder affecting retinal cells) in 17 human patients by intravitreally administering to the human patients the AAVCAGsCD59 viral vector, followed by observing physiological indicia such as changes in the GA area and the drusen volume; the 17 human patients were divided in three cohorts of low, medium, and high AAVCAGsCD59 doses; patients exhibited a decrease in the GA area after AAVCAGsCD59 (claims 1-3, 5, 19-21, and 23) (see p. 366; p. 373, paragraph bridging columns 1 and 2). As evidenced by Park et al., a single AAVCAGsCD59 administration was used in the clinical NCT03144999 (claims 4, 12, and 22) (see p. 10, column 1).
As evidenced by Cashman et al., AAVCAGsCD59 is an AAV2 encoding soluble CD59 (sCD59) from the CAG promoter; sCD59 is obtained by introducing a stop codon in the CD59 cDNA to eliminate the sequence required for the attachment of the GPI membrane anchor (claims 6, 7, 9-11, 13, and 14) (see p. 2, column 1, last paragraph; p. 6, Fig. 7A; p. 7, column 2, second full paragraph). It is also noted that Example 2 in the specification describes the clinical trial NCT03144999; Example 1 discloses that AAVCAGsCD59 used in the clinical trial was obtained as disclosed by Cashman et al. (compare the disclosure of Cashman on p. 7, column 2, second full paragraph to the disclosure in [206] of the specification).
Thus, Hou et al. disclose all claim limitations and anticipate the claimed invention.
Claim Rejections - 35 USC § 103
6. 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.
7. Claims 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over Hou et al. as evidenced by both Cashman et al. and Park et al., in view of both Dugel (Retinal Physician, April 2020, 17: 1-4) and Heier et al. (Lancet, 2017, 390: 50-61), as evidenced by Merten (Cell & Gene Therapy Insights, 2016, p. 521-551).
The teachings of Hou et al. are applied as above for claims 1-7, 9-14, and 19-23.
Hou et al. do not specifically disclose the doses recited in claims 8, 18, and 24. Dugel teaches that a related clinical trial for treating wet AMD used doses of 3.56x1011 and 1.071x1012 vg (see p. 3). One of skill in the art would have found obvious to vary the doses by starting with the doses already used in the prior art, to achieve the predictable result of optimizing the therapy. As evidenced by Merten, vg is the same as DRP (see p. 533, column 1).
Hou et al. do not disclose the physical indicium is BCVA measured as mean change from the baseline (claims 15-17). However, mean change in BCVA was used in clinical trials to evaluate therapeutic efficacy (see Heier et al.; p. 52, column 1, last paragraph; paragraph bridging p. 52 and 53; p. 54, Table 1; p. 58, Fig. 5; p. 59, column 1, first full paragraph). Using mean change in BCVA would have been obvious to one of skill in the art, to achieve the predictable result of assessing the efficacy of AAVCAGsCD59 gene therapy.
The specific value recited in claim 17 represents the mean change in BCVA for cohort 3 in the clinical trial (see Example 2, [312]). This value is not associated with any unexpected therapeutic result, as it is dependent on the individual response to therapy. It was known in the prior art that the level of therapeutic outcome is patient-dependent (see Heier et al., p. 58, Fig. 5). One of skill in the art would have known that the outcome for AAVCAGsCD59 therapy would be patient-dependent. One of skill in the art would have reasonably concluded that the three cohorts of patients would each have a different mean change in BCVA and further that the results obtained with the three cohorts used in the clinical trials would not be reproduced to future cohorts. The recited value is not significant because it does not provide a novel feature.
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
8. No claim is allowed. No claim is free of prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILEANA POPA whose telephone number is (571)272-5546. The examiner can normally be reached 8:00 am to 4:30 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, Christopher Babic can be reached at 571-272-8507. 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.
/ILEANA POPA/Primary Examiner, Art Unit 1633
Prosecution Insights