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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/09/25 was filed after the mailing date of the previous Office Action on 9/24/25. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 6 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 2, 6 and 14, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 3 is/are rejected under 35 U.S.C. 102a1 as being anticipated by 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).
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), meeting limitations of claims 1 and 3. These disclosures render the claims anticipated.
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) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Gulati et al (US 2021/0169978 A1 hereafter Gulati) in view of 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. 29621-29626, 2011 hereafter Ida-Eto) and Liu et al (Inner Ear Drug Delivery for Sensorineural Hearing Loss: Current Challenges and opportunities, Frontiers in Neuroscience, May 2022 hereafter Liu).
Gulati discloses a pharmaceutical composition comprising endothelin (IRL-1620) [abstract], meeting limitations of claims 1. The composition comprises a vehicle including gelatin, sucrose or lipid carrier [0060-0064], meeting limitations of claims 2, 6. The endothelin is present from 0.1-2 mg/kg [0042, 0053-0055], meeting the limitations of claim 3. The composition is present as kit comprising an injectable form with instructions [0012, 0063, claim 13], meeting the limitations of claims 10, 15.
While the reference disclose 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). It would have been obvious to apply the composition of Gulati to improve hearing as Gulati provides a composition that increases expression of endothelin.
Regarding the ear delivery, the combination discloses that it would have been obvious to use the formulation of Gulati to treat endothelin related hearing disorders as compounds found in Gulati act as octoprotectant compounds. Endothelin b receptor octoprotectant compounds are useful when delivered to the art intravenously or intra-typanically as seen in the Liu study.
Lui discloses the challenges and recent developments in treating sensorineural hearing loss (abstract). Octoprotectant compounds in for 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], meting 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.
With these aspects in mind it would have been obvious to combine the prior art to provide a product and method for treating hearing loss by direct ear application. It would have been obvious to combine the prior art with an expected result of a stable method useful in treating hearing loss. It would have been obvious to apply the composition of Gulati to a method of treating hearing loss since low expression of Endothelin receptor agonist is related to such loss as found in Ida-Eto. One of ordinary skill in the art would have followed the suggestions of Edo-Ito to express the compound in a patient in order to repair inner ear vestigial hairs as seen in the Edo-Ito study. It would have been obvious to apply this combination directly to the ear as seen in the Loui study. Liu provides brad methods for direct ear delivery for octoprotectant formulations and the combination of Gulati and Ida-Eto solved the same problem. One of ordinary skill in the art been motivated to apply the composition of Gulati with an expected result in a treatment for hearing loss.
Response to Arguments
Applicant’s arguments, see Amendments/Remarks, filed 12/22/25, with respect to the rejection(s) of claim(s) 1-15 under 25 USC 112 (b), 102 (a1, 2), 103 (a) 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.
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.
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