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 .
Election/Restriction
Applicant's election without traverse of Group I, claims 58-82 in the Reply filed on 03/05/2026 is acknowledged. By way of applicant’s election, claims 83-91 have been withdrawn from further consideration. Further, applicant elected species ‘steroid’ for therapeutic substance that reads on claims 58-62, 64-75, and 77-82. Thus, claims 63 and 76 reciting non-elected species have been further withdrawn.
Therefore, claims 58-62, 64-75 and 77-82 are examined on the merits to which the following grounds of rejections are applicable.
Interview Summary
The Examiner contacted attorney Joshua Puvak on 04/16/2026 to discuss a possible allowability. During the discussions, the Examiner suggested further defining the claimed “reactive composition” based on e.g., 0013], [0046] and [0077] of instant specification to avoid a possible prior art rejection; also she pointed out claim 67 reciting “the chamber” has a 112(b) issue; and she suggested further defining the claimed “therapeutic agents”, and canceling all withdrawn product claims due to a scope different from the elected method invention. However, Attorney did not accept the Examiner’s offer.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/05/2026 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
Claim Objections
Claims 60, 65 and 73 are objected to a minor informality under 37 CFR 1.75.
Each of claims 60 and 73 abbreviations “NTHEs”, “NMDA”, “Wnt”, “GSK-3”, “AAV”, “JNK”, “Kv3”, and “5-HT3”, which should be spelled out at the first encounter in those claims.
Claim 65 recites “and subsequently implantable a cochlear implant”, but which would be better to recite “and subsequently implantable cochlear implant”.
Appropriate correction is requested.
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.
Claim 67 is 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.
Claim 67 recites “the chamber” in line 2, but which lacks sufficient antecedent basis because base claim 58 does not recite “a chamber”.
Appropriate correction is requested.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 58-62, 64, 67-75, 77, 78, and 82 are rejected under 35 U.S.C. 103 as being unpatentable over Lichter et al. (US2018/0110727A1) in view of Buckey, “Use of gases to treat cochlear conditions”, Frontiers in cellular neuroscience, Volume 13, Article 155, published in April 2019, pp. 1-6 and Gonzales et al. (US2005/0074489A1).
Applicant claims the below claims 58 and 69 filed on 03/05/2026:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical method for treating otic related disorder research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from otic disorder related medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Lichter discloses controlled release corticosteroid compositions and methods for the treatment of otic disorders (title) wherein the compositions contain steroid (elected species) including dexamethasone reading on the claimed corticosteroid, methylpredinisolone, etc. (e.g., [0031]) as an active agent (see entire document including abstract and claims) and sodium bicarbonate as a buffer (e.g., [0225]); and the composition is administered directed to cochlear region and perilymphatic space of the cochlea (e.g., [0068]); and the pharmaceutical formulation can be present in the form of gel (e.g., [0208]) (instant claims 58, 67-69 and 82 (in part) and instant claims 60-62 and 73-75); the composition is prepared as a water-free suspension (e.g., [0164] and [0167]) (instant claims 59 and 72); the composition is administered in a sustained release manner (e.g., [0010], [0068], [0125], etc.) (instant claims 64 and 77); this prior art further teaches implanting a fluid transfer conduit to deliver therapeutic agent to the inner ear ([0276]) which reads on the claimed medical device, e.g., cochlear implant (instant claims 70-71); the composition is targeted to e.g., the cochlear region, the tympanic cavity, vestibular bony and membranous labyrinths, cochlear bony and membranous labyrinths (e.g., [0072]) which reads on the claimed fluid-containing chamber (instant claim 78); the composition further comprises additional therapeutic agent including at least one corticosteroid, Na/K ATPase modulator, chemotherapeutic agent, collagen, interferon, anti-TNF agent, IGF-1 modulators, etc. (e.g., [0041] and [0205]), and for example oral dose of corticosteroid is administered prior to administration of the auris-acceptable controlled-release corticosteroid (e.g., [0071])(instant claims 79-81, in part).
However, Lichter does not expressly teach the claimed reactive composition when in contact with the flued, generate a gas, which leads to fluidic movement and propulsion of the therapeutic substance throughout the fluid in the cochlear canal, apical region of instant claims 58, 67-69 and 82. The deficiencies are cured by Buckey and Gonzales.
Buckey discloses gases that can diffuse into the inner ear are attractive as therapeutic agents and the gases include oxygen, hydrogen, carbon dioxide, ozone, argon, etc. (abstract); although the cochlea has barriers to many molecules and drugs, gases can diffuse readily into the cochlea, and if a gas with therapeutic properties can be introduced into the bloodstream it can diffuse into the inner ear and have the desired effect (see e.g., conclusion on page 4).
Gonzales discloses effervescent compositions for medicaments including steroids such as dexamethasone, hydrocortisone, cortisone, corticosterone, fluocinolone, triamcinolone, etc. (e.g., [0039]) and the composition contains gas-generating component upon contact with a minimal amount of water to release gases (abstract); when reacting acidic and basic components in the present of water, gas generates wherein the acidic component includes citric acid, tartaric acid, malic acid, fumaric acid, etc. and the basic component includes carbonate such as bicarbonate, or sesqui-bicarbonate salts of metals such as sodium, potassium lithium, calcium, etc. (e.g., [0014]) and upon contacting with the water vehicle effervesces the gases, which generally serve to penetrate and disperse the medicament within the vehicle (e.g., [0025]) wherein the gas-generating component containing acidic/basic components reads on the claimed reactive composition;
Therefore, it would have been obvious to modify the teachings of Lichter with use of gas of Buckey and Gonzales to achieve the claimed invention because Buckey teaches gas therapy using oxygen or carbon dioxide itself is effective to treat cochlear conditions including hearing loss, and Gonzales teaches gas-generating components penetrates and disperse the medicament e.g., steroid within the aqueous environment, and thus, when administering steroid and acidic/basic components to the basal region of cochlear based on the teachings of Lichter/Buckey/Gonzales, it would have been obvious to expect that the said components contact the aqueous fluid of that basal region of cochlear, leading to fluidic movement and propulsion of the steroid throughout the fluid in the cochlear canal with a reasonable expectation of success. That is, it is well understood that gas generation (effervescence) in aqueous environment produces bubbling, agitation and convective flow, which enhances distribution and transport of dissolved or suspended steroid. In other word, it would have been obvious to modify the teachings of Lichter with use of the effervescent gas-generating system of Buckey/Gonzales such that when in contact with the aqueous fluid of cochlear, generating the therapeutic gases containing steroid and delivering and/or diffusing that gases within cochlear canal, apical region with a reasonable expectation of success (instant claims 58, 67-69 and 82).
In light of the foregoing, instant claims 58-62, 64, 67-75, 77-78, and 82 are obvious over Lichter in view of Buckey and Gonzales.
Claims 65-66 and 79-81 are rejected under 35 U.S.C. 103 as being unpatentable over Lichter et al. (US2018/0110727A1) in view of Buckey, “Use of gases to treat cochlear conditions”, Frontiers in cellular neuroscience, Volume 13, Article 155, published in April 2019, pp. 1-6 and Gonzales et al. (US2005/0074489A1) and further in view of Prenzler et al., “Intracochlear administration of steroids with a catheter during human cochlear implantation: a safety and feasibility study”, Drug delivery and translational research, vol. 8, pp. 1191-1199, 2018.
Lichter was discussed above with respect to instant claims 58 and 69.
However, the applied art of Lichter/Buckey/Gonzales does not expressly teach in combination with cochlear implantation or implant of instant claims 65-66 and 79-81. The deficiencies are cured by Prenzler.
Prenzler discloses a combination therapy of steroid injection and implantation wherein the patients received a deep intracochlear injection of triamcinolone steroid with a specifically designed cochlear catheter during cochlear implantation right before inserting a cochlear implant electrode and as a measure for formation of fibrous tissue around the electrode, impedances were measured in the operation room and over 4 months thereafter (e.g., abstract on page 1191), and such combination therapy is safe and feasible and thus addresses some of the concerns of poor drug distribution, and in that therapy, molecules can only reach the intracochlear space after diffusion through the round window membrane, and in order to achieve a more persistent decrease of impedance, higher concentration of steroid could be used (e.g., conclusion on page 1197).
Accordingly, it would have been obvious to modify the teachings of Lichter/Buckey/Gonzales with a combination therapy of Preznler using medical device implant in order to provide tissue preparation and enhanced therapeutic effects of cochlear disorders as taught by Prenzler (instant claim 65).
Although Prenzler does not expressly teach time ranges of administration prior to the implantation of instant claims 66, and 79-81, Prenzler discloses the implantation is made right after the steroid injection (abstract), which may reasonably embrace about 5-30 minutes or 40 minutes because “right after” does not exclude a short delay and the claimed 5-40 minutes window represents an overlapping or adjacent range. Further adjusting timing affects efficacy, absorption or side effects and thus the ordinary artisan would have routinely optimize timing for best outcome, in the absence of evidence to the contrary (instant claims 66 and 79-81).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613
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