DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to an amendment filed 10/23/2025.
Claims 1-4, 13-16, 46, 47 and 50-70 are pending. Claims 66-70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected, there being no allowable generic or linking claim. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement against these claims, the remaining election has been treated as an election without traverse (MPEP § 818.01(a)). Therefore, claims 1-4, 13-16, 46, 47 and 56-65 are under examination.
This application is a continuation of PCT/2020/023877 filed 3/20/2020 which claims the benefit of U.S. Provisional Application No. 62/821,710, filed March 21, 2019.
Response to Amendments
The amendments are sufficient to overcome the objections to the claims. As well, the rejections under 35 USC 112, second are overcome by the amendments.
The terminal disclaimers filed on 10/23/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on U.S. Patent 11,905,523, U.S. Patents 12,060,390, U.S. Patent 11,981,914 and U.S. Patents 12,091,435 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 4 is objected to because of the following informalities: claim 4 recites two limitations, a therapeutic protein and RNA. Each of these limitations require their own article. The amendment will recite –a RNA--. This is a new observation.
Claim 16 recites the capsid protein comprises “a peptide”. However, by amendment the insertions are now single amino acids and in fact substitutions. The claim should be amended to recite that the capsid comprises a substitution selected from the options. This objection is necessitated by applicant’s amendment.
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-15 and 50-65 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Due to applicants' amendment, the main issues that lead to a rejection under 35 USC 112, first paragraph for lack of enablement have been overcome. The remaining issue cited here is more properly a rejection under 35 USC 112, first paragraph for lack of written description. The previous inclusion in the enablement rejection was due to a number inoperable embodiments that made the ability to perform the invention unpredictable. Applicants' amendment has not overcome the basis of this rejection.
As to claims 56-65, the amendment has necessitated its inclusion in the rejection under 35 USC, 112 first for new reasons which are set forth below.
There are two such issues with the claims as amended. As to claims 13-15, the claims refer to structures in terms of function. Specifically, the claims delineate the properties of the capsid based on what they do. Claim 13 recites that the capsid selectively binds toa receptor expressed on the surface of a cell in the CNS while claim 15 of a cell in the heart. Claims 50-55 similarly, claim the properties of the vector in terms of to what cell the vector “selectively delivers the cargo”. The capsid comprises sequences that direct the virus to specific receptors. Modifications to redirect AAV by engineering the capsid protein to alter the tropism of AAV to reduce liver tropism (natural tropism) and increase muscle tropism involves inserting peptide sequences into the capsid. Considering claims 13-15 and 50-55, these claims recite specific functions and they are not supported by any disclosure that would demonstrate that the structural properties as recited have these functions. They are desired functions without clear indication that the structure can provide the selective binding in the particular cells.
As to claims 56-65, the claims refer to a polynucleotide encoding a recombinant capsid but the characteristics of the capsid are only described in terms of a first and second peptide that are located int eh capsid at first amino acids 587-594 and 451-458. These are not position in any specific capsid but “correspond to amino acids” of the native AAV9 capsid. The formal structure of the capsid by this recitation is broad and simply limits the claim to the two peptides and not a particular capsid. One would have to identify capsids with amino acids of 587-594 and 451-458 and no other properties.
To this end, the MPEP provides such guidance (emphasis added). If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Compare Fonar, 107 F.3d at 1549, 41 USPQ2d at 1805 (disclosure of software function adequate in that art).
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.
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/MARIA MARVICH/ Primary Examiner, Art Unit 1631