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
Status of 18/204,812
Claims 1-6 are currently pending.
Priority
Instant application 18/204,812, filed 6/1/2023, does not claim priority. Thus, the effective filing date of claims 1-6 is 6/1/2023.
Information Disclosure Statement
No information disclosure statement has been filed as of 2/2/2026.
Objection to the Title
The title is objected to as it contains the word, “ketoe”. The word “ketoe” is not defined in the instant disclosure and not known to one of ordinary skill in the art. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claims 2-6 are objected to because they read “Claim” but should read “claim”, as it is not a proper noun. Appropriate correction is required.
Claims 3 and 4 are objected to because they read, “The methods of” but should read “The method of”. Appropriate correction is required.
Claims 3 and 4 are objected to because they read “thew”, but should read “the”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-6 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.
Claim 1 recites multiple instances of parentheses. The phrases within the parentheses are considered indefinite because they are exemplary language and it is not clear if the contents of the parentheses are required, or just examples of what is required. Appropriate correction is required.
Claim 2 recites the limitation, “other liquid vehicle”, in reference to the addition of a component to the composition. It is unclear what an “other liquid vehicle” is, and the limitation is not defined in the disclosure. Thus, the limitation is deemed indefinite. Dependent claims 4 and 6 do not resolve this limitation by claiming a specific other liquid vehicle or defining the term and are therefore also rejected. Appropriate correction is required.
Claims 3 and 4 are rejected because they recite the limitation, “other antibiotic agents”, in reference to the addition of an antibiotic agent to the composition. Similar to the rejection above, it is unclear what an “other antibiotic agent” is, and the limitation is not defined in the disclosure. Thus, the limitation is deemed indefinite. Dependent claim 5 does not resolve this limitation by claiming a specific other antibiotic agent or defining the term and is therefore also rejected. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Diamondback Drugs of Delaware (US 2017/0196804 A1, herein after “Diamondback”). The instant claims are drawn to a method of topically treating a fungal ear infection in humans with ear drops comprising the steps of forming a liquid composition containing ketoconazole and applying the composition inside the ear canal of a human patient until cured.
The reference Diamondback discloses methods for treating ear infections in animals that includes forming a liquid composition having an antifungal agent, an antibiotic agent, a steroidal anti-inflammatory agent, an anhydrous organic acid, liquid dehydrated alcohol, and propylene glycol, that is then applied in drop form to the ear until the infection has been cured (abstract). Specifically, Diamondback discloses the step of forming a liquid composition containing the anti-fungal ketoconazole, the anti-inflammatory steroid triamcinolone diacetate, and citric acid dissolved in dehydrated alcohol, the step of dissolving ofloxacin in propylene glycol, and the combination of the two solutions to form a solution (paras [0035]-[0037]). The Examiner notes the use of the term “comprising the steps” in claim 1 as open-ended. Additionally, Diamondback discloses the administration of the solution inside the ear canal of a dog with otomycosis until cured (paras [0042]-[0044]), and claim 1 of Diamondback recites a broader method of treating ear infections in animals, comprising the steps of forming a liquid composition and applying the composition inside the ear of the animal until the infection has been cured. Though Diamondback does not explicitly disclose additional patient populations,
the broadest reasonable interpretation of animal includes humans, as evidenced by Brittanica’s (https://www.britannica.com/animal/animal/The-nervous-system) definition of “animal” as, “any
of a group of multicellular eukaryotic organisms”, and one skilled in the art could at once envisage the method used in humans. Thus, Diamondback anticipates claims 1-6 as evidenced by Brittanica.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Diamondback Drugs of Delaware (US 2017/0196804 A1, herein after “Diamondback”).
The instant claims are drawn to a method of topically treating a fungal ear infection in humans with ear drops comprising the steps of forming a liquid composition containing ketoconazole and applying the composition inside the ear canal of a human patient until cured.
Determining the scope and contents of the prior art
Diamondback teaches as disclosed above and at least those teachings are incorporated herein.
Ascertaining the differences between the prior art and the claims at issue
Diamondback fails to teach a working example of a method of topically treating fungal ear infection with ear drops in humans.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of methods of treating ear infections with drops containing ketoconazole until cured. An artisan possess the technical knowledge necessary to make adjustments to the methods to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to methods of treating ear infections with drops containing ketoconazole until cured and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Above, the Examiner took the position that a skilled artisan could at once envisage the method of treating fungal ear infections of Diamondback in humans because the broadest reasonable interpretation of “animal” includes humans. In the alternative, applying KSR prong (B), it would have been prima facie obvious for one of ordinary skill in the art to substitute the patient population of canines of Diamondback with the patient population of humans of the instant claims because they are both considered animals, which the teachings of Diamondback are drawn to. One of ordinary skill in the art would be motivated before the effective filing date to treat fungal ear infections in humans with the ketoconazole containing ear drops of Diamondback because it is known in other animals, and is thus expected to have similar results. A skilled artisan would have readily predicted that applying the methods of treatment of fungal ear infections of Diamondback to humans would be successful in light of the teachings of Diamondback.
Conclusion
Claims 1-6 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621