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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 05/01/2026 has been entered.
Claims 21-33 and 35-40 are pending in the present application, and they have been allowed in the Notice of Allowability dated 02/04/2026 (including Examiner’s Amendment to claims 35 and 40).
The IDSs filed on 05/01/2026 and 05/06/2026 have been considered by the Examiner. None of the cited references alone or in combination that are cited in these newly submitted IDSs teach or fairly suggest a non-naturally occurring polynucleotide cassette comprising in 5’ to 3’ order the elements (a)-(h) as recited in independent claim 21; a recombinant virus comprising the same polynucleotide cassette; and a pharmaceutical composition comprising the same recombinant virus. Moreover, the claimed polynucleotide cassette (designated as Cassette No. 14 in the present application) exhibits an unexpected and improved property with a consistently high expression level of a secretory protein in at least HeLa cells, HEK293 cells and transduced pig retinal explants over tested similar Cassette Nos. 15-17 (see at least paragraphs [0046]-[0049], and particularly FIGs. 1-4).
However, upon further consideration although claims 21-32 and 35-40 are still allowable, there is a 112(b) issue with claim 33.
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.
Claim 33 is rejected 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 which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 33 is vague and indefinite in that the metes and bounds of the term “derived from” are unclear. It is unclear the nature and number of steps required to obtain a capsid protein derivative of “the AAV variant 7m8 capsid protein”. The term implies a number of different steps that may or may not result in a change in the functional characteristics of the capsid protein from the source. Moreover, there is no definition of the term “derived from” in the present application. It would be remedial to amend the claim language to use the term “obtained from”, which implies a more direct method of acquiring the capsid protein.
Conclusions
Claims 21-32 and 35-40 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Quang Nguyen, Ph.D., at (571) 272-0776.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s SPE, James Douglas (Doug) Schultz, Ph.D., may be reached at (571) 272-0763.
To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Group Art Unit 1633; Central Fax No. (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/QUANG NGUYEN/Primary Examiner, Art Unit 1631
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