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 . 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.
Continued Examination Under 37 CFR 1.114
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 17 Nov, 2025 has been entered.
Election/Restrictions
Applicants elected group I (formulations) and a formulation comprising poloxamer 407, neurotrophin 3, and SEQ ID 1 without traverse in the reply filed on 24 Sept, 2024.
Claims Status
Claims 1, 52, and 80 are pending.
Claim 1 has been amended.
Withdrawn Objections
The objection to the specification due to the lack of SEQ ID numbers is hereby withdrawn due to amendment.
Withdrawn Rejections
The rejection of claim(s) 1, 52, and 80 under 35 U.S.C. 103 as being unpatentable over Suzuki et al (Sci. Rep. (2016) 6-24907) in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to argument.
The provisional rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/200,812 (US 20240226141) in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to argument.
The provisional rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 49 of copending Application No. 18/444,107 (US 20240309399) in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to argument.
The rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US 10,813,947 in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to amendment.
The rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 22 of US 10,709,732 in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765). is hereby withdrawn due to amendment.
The rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US 11,071,751 in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to amendment.
The rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US 11,690,870 in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to amendment.
The rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of US 11,857,567 in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to amendment.
The provisional rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 39 of copending Application No. 18/568,077 (US 20240285803) in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to amendment.
The provisional rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 25 of copending Application No. 18/289,028 (US 20240216540) in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to amendment.
The provisional rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 53 of copending Application No. 18/289,028 (US 20240148905) in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to amendment.
The provisional rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/278,053 (US 20240226331) in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to argument.
The provisional rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13 of copending Application No. 17/735,221 (US 20220331449) in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to amendment.
The provisional rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 27 of copending Application No. 17/735,326 (US 20220288236) in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to amendment.
The provisional rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/284,074 (US 20210355504) in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to amendment.
The rejection of claims 1, 52, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16 of U.S. Patent No. 12,233,136 in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765) is hereby withdrawn due to amendment.
New Rejections
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1, 52, and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al (Sci. Rep. (2016) 6-24907) in view of Goycoolea et al (Microscop. Res. Tech. (1997) 36 p201-211, cited by applicants) and Bocsik et al (J. Pharma. Sci. (2016) 105 p754-765).
Suzuki et al describe the effect of neurotrophin 3 on acoustically damaged cochlear synapses (title). The therapy was effective in restoring cochlear function in mice after several days (2nd page, 5th paragraph). The material was formulated as a gel using a poloxamer to form extended release gels (8th page, 3d paragraph), specifically, poloxamer 407 with PBS (8th page, 9th page). However, the administration involved surgery to make a hole in the otic window (8th page, 5th paragraph), and mentions using a needle to do so in humans (abstract).
The difference between this reference and the claimed formulation is that this reference does not describe a permeation enhancer.
Goycoolea et al discuss the otic membrane in the context of permeability (title). The outer epithelial layer is a single layer of cells comprising tight junctions (p201, 1st column, 3d paragraph, continues to 2nd column). This covers a core of connective tissue, where the fibers are loosely arranged (p201, 2nd column, 2nd paragraph), i.e. porous. The inner layer is epithelial cells, but there are gaps in between them (p202, 1st column, 2nd paragraph, continues to 2nd column). This reference suggests that the main barrier to compounds is the tight junctions of the outer epithelial layer.
Bocsik et al discuss reversibly opening epithelial tight junctions using modulator peptides (title). Among the sequences tested is PN-159 (table 1, p755, bottom of page), identical with SEQ ID 1 of the examined application. PN-159 was one of the most effective sequences in opening up a small number of model systems (p757, 2nd column, 6th paragraph, continues to p758, 1st column, 3d paragraph). Note that this sequence has every structural feature that applicants have stated is required for a helical facially amphipathic sequence, so that is an inherent feature of the sequence. Experiments used 1 mM concentrations (p756, 1st column, 2nd paragraph), which is, in round numbers, 0.2% w/vol. This reference shows that SEQ ID 1 of applicants is known in the art for opening tight junctions, such as the ones that Goycoolea et al state are found in the otic window.
Therefore, it would be obvious to try the peptides of Bocsik et al individually in the formulation of Suzuki et al, to allow the formulation to open the tight junctions discussed by Goycoolea et al and allow the drug access past the otic membrane without compromising its integrity. As these are known tight junction modulator peptides, an artisan in this field would attempt these peptides with a reasonable expectation that one would be effective.
Adding the permeation enhancer sequence of Bocsik et al to the formulation of Suzuki et al will add a peptide of SEQ ID 1 to neurotrophin 3. Thus, the combination of references renders obvious claim 1.
The polypeptide is at about 0.2% w/vol, rendering obvious claim 52.
The formulation of Bocsik et al comprises PBS, an aqueous solution, rendering obvious claim 80.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658