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 .
Claim Interpretation
Applicant refers to both a SANS protein and a vector comprising the USH1G gene. It is known in the art that the USH1G gene is responsible for creation of the SANS protein, and the two terms are considered to be two names for the same protein in the art. Therefore, art reading on a SANS protein will be considered to also read on the USH1G gene and art reading on the USH1G gene will be considered to also read on a SANS protein. Furthermore, the specification of the claimed invention states that the present invention is directed towards a potential treatment for Usher syndrome, in particular tailored to the USHG1 subset. (Pg 1, Summary of the invention) Therefore, prior art teaching treatment of Usher syndrome, particularly one that further specifies use of USHG1, will read on the method of claim 15 of “a method for treating USH1G syndrome”.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 15-30 are rejected under 35 U.S.C. 103 as being unpatentable over Stankovic et al. (WO 2017/100791) in view of Chakraborty et al. (US 9220755 B2)
Regarding claims 15, 22, 23, 29, and 30: Stankovic teaches an AAV vector comprising an Anc80 capsid protein and one or more transgenes, including USH1G, which is delivered to the inner ear of a subject. (Pg 56, claims 1, 2, and 6) Stankovic further teaches that the administration step comprises injecting the composition through the round window of the inner ear. (Pg 58, claims 18-19) Lastly, Stankovic teaches that the claimed invention is intended to be used to treat a hearing disorder such as Usher syndrome, syndromic deafness, or age-related hearing loss. (Pg 17, ln 8-13) As the USH1G gene encodes for production of the SANS protein, this reads on the claimed method of the treatment of USH1G syndrome by administering a vector expressing a SANS protein encoded by the USHG1 gene. As Stankovic teaches the invention may be used to treat age-related hearing loss, this reads on the claimed method of the patient having a developed and mature auditory system.
Stankovic fails to explicitly disclose administration of the composition to a human patient or that the composition is injected bilaterally. However Stankovic teaches that the disclosed invention may be used to treat Usher syndrome and other hearing disorders. (Pg 17, ln 8-13) Stankovic further teaches an example of the invention which makes use of human vestibular epithelia isolated from adult human patients which are transfected with a GFP protein via Anc80 AAV and demonstrate GFP fluorescence, which strongly suggests the AAV of the claimed invention can successfully be used to transfect adult human vestibular organs. (Pg 33, Example 1C, ln 17-26) Stankovic further demonstrates in Example 2A that gene therapy using the claimed invention demonstrated preservation of hair cell numbers in an Usher disease mouse model. (Pg 38, ln 16-21) It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Stankovic to the treatment of a human patient (be it a newborn, toddler, infant, teenager, or adult, thus reading on both claims 22 and 29) due to the successful use of Anc80 AAV to transfect human vestibular tissue with GFP and the successful preservation of hair bundles in an Usher mouse model. One would be motivated and have a reasonable expectation of successful treatment in humans due to Stankovic demonstrating successful transmission of a GFP into human vestibular tissue using the Anc80 of the claimed invention, as demonstrated in example 1C. Furthermore, a person of ordinary skill in the art would understand that, in order to successfully treat a hearing disorder such as Usher syndrome or USHG1 syndrome, one would need to treat bilaterally to address both affected ears. Therefore, the method of claims 23 and 30 are rendered obvious.
Regarding Claim 16: Stankovic teaches an embodiment of the invention which an Anc80 capsid protein and SANS transgene are encoded in an AAV vector. (Pg 2, ln 4-9) One would be motivated to select SANS as the transgene of interest, as Stankovic teaches that it is a transgene representative of Usher syndrome that when expressed, restores hearing to the subject. (Pg 5, ln 5-8)
Regarding claim 17: Chakraborty teaches multiple compositions and methods for the preparation, manufacture, and therapeutic use of polynucleotides, primary transcripts, and mmRNA molecules. (57) Chakraborty further teaches that there is a need in the art for therapeutic modalities to overcome barriers regarding effective modulation of intracellular translation and processing of nucleic acids, and states that the modified mRNA sequences presented have potential as therapeutics which have features that avoid barriers like thresholds of expression, improving expression rates and half-life, optimizing protein localization, and avoiding the immune response and/or degradation pathways. (Col 6, ln 25-51) One of the sequences, SEQ ID NO. 69422, encompasses both SEQ ID NOs. 1 and 3 of the claimed invention, as shown in the alignment charts below:
Matching seq id 1:
PNG
media_image1.png
682
720
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Greyscale
Matching seq id 3:
PNG
media_image2.png
524
728
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Greyscale
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate SEQ ID NO. 69422 as taught by Chakraborty into the AAV vector comprising an Anc80 capsid protein and USH1G transgene as taught by Stankovic to create a USH1G Anc80 vector comprising a sequence matching either SEQ ID NO. 1, SEQ ID NO. 3, or both, as the sequence taught by Chakraborty encompasses both. One would have been motivated to do so and had a reasonable expectation of success due to the teachings of Chakraborty of the sequences of their claimed invention being built in a way that allows for avoiding barriers like thresholds of expression, improving expression rates and half-life, optimizing protein localization, and avoiding the immune response and/or degradation pathways.
Regarding claims 18-21 and 26: Stankovic teaches that the method of delivery for the claimed invention is based on an AAV and specifically contains an Anc80 capsid protein due to the Anc80 vector being “surprisingly efficient” at targeting cells of the inner ear in vivo. (Pg 2-3, ln 27-4) This reads on the method of claim 18 (viral vector), claim 19 (AAV vector), claim 20 (AAV1, AAV2, AAV8, AAV9, or Anc80) and lastly, claims 21 and 26 (Anc80 or AAV2/8).
Regarding claim 24: Stankovic teaches use of delivery vehicles as part of the disclosed invention. (Pg 22, ln 6-9)
Regarding claims 25 and 28: Stankovic teaches that the vector of the claimed invention may comprise SANS (pg 2, ln 4-9) and that in some embodiments, the vector is administered via injection through the round window of the ear. (Pg 3, ln 25-27) Furthermore, Stankovic teaches that SANS is one of the genes representative of Usher syndrome and that when expressed, restores hearing to the subject. (Pg 5, ln 5-9) Therefore, a person skilled in the art would be motivated to incorporate SANS as an injectable composition for the treatment of Usher and, more specifically, USH1G syndrome based on the knowledge of expression of the SANS protein being associated with the treatment of the disease.
Allowable Subject Matter
Claim 27 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Both SEQ ID NOs. 2 and 19 are free of the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA M THUESON whose telephone number is (571) 272-3680. The examiner can normally be reached M-F 7:30-5 EST. 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.
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/HANNA MARIE THUESON/ Examiner, Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638