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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/24/26 has been entered.
Claim Objections
Claim 6 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative. See MPEP § 608.01(n). Accordingly, the claim 6 not been further treated on the merits.
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.
Claim(s) 4-12, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Liu et al (Inner Ear Drug Delivery for Sensorineural Hearing Loss: Current Challenges and opportunities, Frontiers in Neuroscience, May 2022 hereafter Liu) in view of Li et al (Mitigating the effects of Endothelin-1 following a minimally invasive surgery reduces the blood-brain barrier permeability in a rabbit model of intracerebral hemorrhage, Brain Hemorrhages, 3, 2022, 177-183 hereafter Li) and Ida-Eto et al (Partial Requirement of Endothelin Receptor B in Spiral Ganglion Neurons for Postnatal Development of Hearing, The Journal of Biological Chemistry, vol. 286, no. 34, pp. 29621, 2011, hereafter Ida-Eto).
Lui discloses the challenges and recent developments in treating sensorineural hearing loss (abstract). Octoprotectant compounds in the form of hydrogels can and should be delivered intra- tympanic, intracochlear, and other direct ear delivery methods [Table 2], meeting limitations of claim 4. The methods for treating sensorineural hearing loss including intra-tympanically injections including direct injections into the endolymphatic sac [Figures 3, page 7], meeting the limitations of claims 7-9. Drug coated and impregnated cochlear implants are also known for intracochlear delivery [pg. 7], meeting the limitations of 11. Pharmaceutical delivery may also include nanoparticle delivery [Table 2], meeting the limitations of claim 12. It would have been obvious to apply the formulation of the combination to the method of Lui as the combination is octoprotective and can be delivered in a variety of direct ear means.
Lui discloses a method of treating hearing loss but is silent to the specific endothelin B compounds. Li discloses an endothelin B compound that can be delivered directly to the inner ear.
Li teaches a pharmaceutical composition, formulated for delivery to the ear, comprising endothelin B receptor analogs such as IRL-1620 (abstract). The formulation is administered to the ear and comprises about 20 µg (pg. 178). It would have been obvious to include the compound of Li into the method of Liu as they solve the same problem.
While the reference discloses the delivery of an endothelin receptor to the body via injection where the composition comprises a vehicle and other excipients along with a kit presentation with instructions and materials for injection, the reference is silent to a specific ear delivery. The reference is further silent to the specific treatment of sensorineural hearing loss, however hearing loss disorders related to impairments of endothelin receptor b are known in the art as seen in the Ida-Eto study.
Ida-Eto discloses how endothelin receptor B deficiencies affect hearing loss (abstract). Endothelin receptor B (Ednrb) expression is found in the spiral ganglion of the inner ear is responsible for hearing and as the expression decreases, deafness increases (abstract). The study indicates that an enhancement of Ednrb is a novel strategy for congenital hearing loss (pp29626). Ita establishes the level of skill in the art regarding how endothelin receptor B compound effect hearing loss and their relationship to spiral ganglion of the inner ear and would have been an obvious addition to the method of Liu.
With these aspects in mind, it would have been obvious to combine the prior art in order to produce a method for treating hearing loss. It would have been obvious to apply the formulation of Li into the methods of Lui and Ita-Edo as they all seek to solve the same problem of treating hearing loss in the inner ear. One of ordinary skill in the art would have been motivated to combine the prior art in with an expected result of a stable means of treating hearing loss in the inner ear.
Allowable Subject Matter
Claims 1-3, 13 and 16 are allowed.
Response to Arguments
Applicant’s arguments, see Remarks, filed 6/24/26, with respect to the rejection(s) of claim(s) 1-15 under 35 US 102, 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/ Primary Examiner, Art Unit 1618
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