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 .
DETAILED ACTION
Claims 58-82 and 92-93 are pending in a Response of 07/27/2026. Claims 63 and 76 have been withdrawn, and consequently, claims 58-62, 64-75, 77-82 and 92-93 are being examined at this time.
Withdrawn rejections:
Applicant's amendments and arguments filed 07/27/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
New Ground of Rejection --- as necessitated by amendment
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, 82, and 92-93 remain/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 07/27/2026:
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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 therapeutic substance corticosteroid, methylpredinisolone reading on the claimed steroid, etc. (e.g., [0031]) as an active agent (see entire document including abstract and claims) and sodium bicarbonate as a buffer (e.g., [0225]) which may read on the claimed reactive composition generating gas and the composition is administered to cochlear region and perilymphatic space of the cochlea (e.g., [0068]), and please note that the basal region of the cochlear canal contains the perilymphatic space as supported by instant Figs. 1A and 1B, and the pharmaceutical formulation can be present in the form of gel (e.g., [0208]); and the composition is injected via needle, syringe and microinjection device which reads on the claimed injection (instant claims 58, 67-69 and 82 (in part) and instant claims 60-62 & 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 ([0210] and [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); and the composition containing corticosteroid or steroid comprises stabilizers including any antioxidants, buffers, acids, etc. in order to improve the compatibility of excipients, the stability of a component of the composition, or formulation stability ([0096]).
Lichter teaches sodium bicarbonate buffer ([0225]), and however, Lichter does not expressly teach specific selection of the reactive composition when in contact with the fluid, 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; and combination of instant claims 92-93. The deficiencies are cured by Buckey and Gonzales.
Buckey discloses although the cochlea has barriers to many molecules and drugs, 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, the 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, and the effervescent formulations include one or more medicaments for administration to the patient such as anti-inflammatory agent, e.g., acetaminophen, NSAID, steroids such as corticosteroid, dexamethasone, antibiotic, antihistamine, etc. ([0039] and claims 2 and 20 of prior art), particular, this prior art discloses a combination of sodium bicarbonate, sodium carbonate and citric acid along with acetaminophen ([0115] – Example) (instant claims 92-93).
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 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 medicament such as 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, and taking a combination of gas-generation components, sodium bicarbonate as basic ingredient and citric acid as acidic ingredient would be obvious because they generate gas when reacting with aqueous solution (instant claims 58, 67-69 and 82). Further, it would have been obvious to further define medicament of Lichter with anti-inflammatory agent, antibiotics, antihistamine of Gonzales (claims , and selecting certain medicament depending on the intended therapeutic effects would be a matter of choice (instant claims 92-93).
In light of the foregoing, instant claims 58-62, 64, 67-75, 77-78, 82 and 92-93 are obvious over Lichter in view of Buckey and Gonzales.
Claims 65-66 and 79-81 remain 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/Buckey/Gonzales were discussed above with respect to at least instant claims 58 and 69.
However, the applied art of Lichter/Buckey/Gonzales do 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 Prenzler 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 optimized 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.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that Lichter fails to disclose the claimed reactive composition and its functional properties, and Buckey discloses the use of gases, in particular oxygen and hydrogen (although other gases such as carbon dioxide) via diffusion to treat cochlear condition and thus the mechanism is different from the claimed administration, and the use of carbon dioxide in Buckey cannot reasonably be considered the claimed reactive composition that generates a gas leading to propulsion and fluidic movement of a therapeutic substance throughout fluid within the cochlea; Gonzales fails to cure the deficiencies of Lichter/ in that the mechanism of delivery requires ingestion by the patient, not injection or direct administration at a tissue site within the body; and Prenzler also fails to disclose the claimed reactive composition and functional properties.
The Examiner responds that Lichter discloses local administration of corticosteroid and sodium bicarbonate buffer (abstract, [0011], [0054], [0066] and [0225]), and however Lichter does not expressly teach selection of gas-generating buffer; Buckey is relied on to establish the relevance and behavior of gas in the cochlear environment – i.e., that carbon dioxide gas can reach and act within the inner ear/cochlear area, and in this respect, Buckey states the gases can diffuse into the cochlea and specifically concludes that when that gases are introduced into the bloodstream, it can diffuse into the inner ear and have the desired therapeutic effects on cochlear blood flow. Please note that secondary Buckery is not relied on to supply the claimed administration of the therapeutic agent because Lichter supplies that limitation. The claimed mechanism involving generation of gas and resulting fluid movement/propulsion is provided by Lichter in view of Buckey as noted in the body of Action; Gonzales is not relied on for teaching direct administration or injection, but for its teachings concerning the known operation of an effervescent pharmaceutical composition – namely that an effervescent component (e.g., sodium bicarbonate and citric acid) reacts in an fluidic vehicle to generate gas and that the resulting gas/effervescence disperses and distributes a medicament within the vehicle and enhances penetration of the medicament in the vehicle; and Prenzler is relied for disclosing cochlear implantation. Please note that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In reKeller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In reMerck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145.
Further, instant claim 58 does not require “direct” administration or injection element.
In light of the foregoing, applicant’s arguments are not persuasive.
Suggestion
The Examiner suggested, on October 2, 2026, incorporating claims 92 and 93 into claims 58 and 67, respectively, for a potential allowability, and attorney did not accept it. However, since Gonzales discloses such combination, claims 92-93 are rejected as noted above.
The specification does not provide any tested data concerning the claimed method. The claimed composition in the method requires a reactive composition generating gas and myriads of therapeutic substances. It may not be said that any reactive composition and therapeutic substances as claimed would behave in the same or very similar manner as intended, without evidence.
Conclusion
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, and but it may be used in the next action:
WO2020/005815A1 (IDS of 01/08/2024 – e.g., [0087] and [0092]): Body fluid is reacted with sodium bicarbonate to create a gas (e.g., carbon dioxide gas), which may be discharged as a pressurized fluid/gas jet to create propulsion, and that is, this reference provides known functional property/role of sodium bicarbonate when contacted with an appropriate fluid, resulting in generation of gas (CO2).
No claims are allowed.
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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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.
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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