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 .
Claims 1, 2, 6-12 and 16-18 are pending.
This office action is in response to an amendment filed 9/16/2025.
The instant application is a divisional of 15/445,776 filed 2/28/2017 now abandoned which claims priority to provisional application 62/301,266 filed 2/29/2016.
Response to Amendments
Amendments to place the case in condition for allowance were presented but a response was not received within the time allotted to act on this application.
Claim Objections
Claims 1, 9, 11 and 17 are objected to because of the following informalities: for streamlined recitation, in line 9, the phrasing should be –the regulatory sequence is a human G-protein-coupled receptor kinase 1 (GRK1) promoter--. The claim previously states the sequence is linked to a promoter.
For consistency, claims 8 and 10 should recite –the amino acid sequence--.
The sequences of claims 9 and 11 should be as in claims 8 and 10 –sequence of SEQ ID NO:--.
For consistency, claim 17 should recite that the AAV2/8 capsid is AAV8(Y447F+Y733F+T494V). The Y is missing from the middle mutation.
Appropriate correction is required.
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
Claims 2 and 6 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. This is a new rejection.
Claim 2 recites use of rAAV that comprises specific mutations in the AAV capsid and include Y447. The disclosure only provides for Y447F. The mutation is critical for the function of the therapy and hence requires a specific modification.
Claims 6 recites the NPHP5 protein is a human sequence. This provides for a large genus of sequences. However, the disclosure only recites that the NPHP5 protein is a human NPHP5 protein. The specification only teaches that full-length human NPHP5 is effective not just any human sequence. The claims thus are drawn to a large genus of peptides which are not sufficiently described in the specification. The written description requirement for genus claims may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with known or disclosed correlations between function and structure, or by a combination of such characteristics sufficient to show that the applicant was in possession of the claimed genus.
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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/MARIA MARVICH/Primary Examiner, Art Unit 1631
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