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 .
Foreign Priority
Examiner notes that no certified translation of the Foreign Application WO 2021-045569A1 (published 2021-03-11) or KR 102175201 B1 (filed 2020-11-06) has been placed on record. If applicant wants the application to be accorded benefit of the non-English language application, a certified translation is required (see 35 U.S.C. 119(b)(3), 37 CFR 1.55(g)(1)-(4)). Applicant is advised that any showing of priority that relies on a non-English language application is prima facie insufficient if no certified translation of the application is on file. See 37 CFR 41.154(b).
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5, and Example 1 (see Specifications filed 04/25/2022, p. 8-9, para. [0038-0043]), in the reply filed on 11/28/2024 is acknowledged.
Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/28/2024.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The IDSs filed 03/03/2022 and 08/27/2023 are acknowledged and presently considered.
Claim Interpretation and Examiner Notes
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claim 1 is representative of the pending claim scope, and the applicable claim interpretation is set forth below.
Claim 1 is drawn to a method of preventing or treating sensorineural hearing impairment by administration of a pharmaceutical composition comprising bilberry extract.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
“Bilberry extract” is understood to refer to a product of an extraction process intended to isolate a compound or compounds from a biomass. The intended compound of the application was not defined, and the method of extraction was restricted to Example 1 (see, e.g., Specification filed 04/25/2022, p. 8-9, para. [0038-0044]) as stated in the Remarks filed 11/28/2024.
“Sensorineural hearing impairment” is understood to refer to hearing loss that occurs due to damage to the inner ear or auditory nerve connected to the brain. Sensorineural hearing loss can be caused by aging (senile hearing impairment), exposure to loud noises (sudden hearing impairment), head trauma (traumatic hearing impairment), medications (ototoxic hearing impairment), inner ear infections, or genetic disorders (congenital hearing impairment).
“Apoptosis” is understood to refer to a regular cell death, and the application specifies the apoptosis of auditory cells. The apoptosis of inner and out hair cells within the ear structure contributes to hearing loss (see, e.g., Specification filed 04/25/2022, p. 3, para. [0011])
Additional claim interpretations are set forth below.
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.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by KR 102175201 B1 (published 11/06/2020), as evidenced by ‘Machine Translation of KR 102175201 B1’ (accessed 01/10/2025, 29 pages, Machine Translation by Espacenet.org, further known as ‘Trans’201’).
Regarding claim 1 and a method of preventing or treating sensorineural hearing impairment by administration of a pharmaceutical composition comprising bilberry extract as an active ingredient, KR’201 teaches a pharmaceutical composition comprising bilberry extract as an active ingredient for treatment of sensorineural hearing loss (see, e.g., Trans’201, ‘Claims’ 1, 5, and 6, p.1-2; ‘Description’, p.3, para. [0001]).
Regarding claim 1 and 2 and a method of extracting bilberry extract with water, C1 to C2 alcohol, or an aqueous solution of water and a C1 to C2 alcohol, KR’201 teaches bilberry extract extracted with C1 to C2 alcohol or an aqueous solution thereof (see, e.g., Trans’201, ‘Claims’ 1, p.1; ‘Description’, p.10, para. [0017]).
Regarding claims 1 and 3 and the method of treating or preventing hearing sensorineural hearing impairment, KR’201 teaches the method of treating or preventing hearing sensorineural hearing impairment “from the group consisting of sudden hearing loss, ototoxic hearing loss, noise-induced hearing loss, traumatic hearing loss, presbycusis, and congenital hearing loss, but is not limited thereto” (see, e.g., Trans’201, ‘Description’, p.10, para. [0019]).
Regarding claims 1 and 4 and the method of inhibiting apoptosis of auditory cells and increases the number of hair cells by bilberry extract, KR’201 teaches a method of inhibiting apoptosis of auditory cells and increases the number of hair cells by bilberry extract (see, e.g., Trans’201, ‘Description’, p.11, para. [0020]).
Regarding claims 1 and 5 and the pharmaceutical composition comprising 0.1 to 90 parts bilberry extract per total weight, KR’201 teaches a method of preparing a pharmaceutical composition containing 0.1 to 90 parts by weight of bilberry extract per 100 parts by weight of the pharmaceutical composition (see, e.g., Trans’201, ‘Claims’ 1, 5, and 6, p.1-2; ‘Description’, p.11, para. [0021]).
Therefore, claims 1-5 are anticipated by KR’201 as the claimed invention in claims 1-5 have been described and patented by KR’201.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2011037738 A (published 02/24/2011), as evidenced by ‘JP 2011037738 A Machine Translation’ (accessed 01/10/2025, 80 pages, Machine Translation by Espacenet.org, further known as Trans’738).
Regarding claims 1 and 3 and a method of preventing or treating sensorineural hearing impairment by administration of a pharmaceutical composition comprising bilberry extract as an active ingredient, JP’738 teaches a preventative or treatment for age-related hearing loss, noise-induced hearing loss (both sensorineural hearing losses), or tinnitus by administration of a compound from a group including bilberry extract (see, e.g., Trans’738, ‘Claims’ 1 and 2, p.1; ‘Description’, p.7-8, para.[0001-0002]).
Regarding claim 1 and 2 and a method of extracting bilberry extract with water, C1 to C2 alcohol, or an aqueous solution of water and a C1 to C2 alcohol, JP’738 teaches a method of extracting bilberry extract with alcohols or a mixture of alcohol and water (see, e.g., Trans’738, ‘Description’, p. 29, para. [0016]).
Regarding claims 1 and 4 and the method of inhibiting apoptosis of auditory cells and increases the number of hair cells by bilberry extract, JP’738 teaches a method of treating the loss of hair cells in the inner ear, degeneration of nerve fibers, and loss of spiral ganglion cells by administration of bilberry extract (see, e.g., Trans’738, ‘Claims’ 1 and 2, p.1; ‘Description’, p. 7-8, para. [0002]).
Regarding claims 1 and 5 and the pharmaceutical composition comprising 0.1 to 90 parts bilberry extract per total weight, JP’738 teaches a pharmaceutical composition comprising 0.1 - 95% by weight of bilberry extract (see, e.g., Trans’738, ‘Description’, p.36, para. [0024], lines 1375-1377).
Therefore, claims 1-5 are anticipated by JP’738 as the claimed invention in claims 1-5 have been described and patented by JP’738.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH MARIE ELISE SEAY whose telephone number is (703)756-5855. The examiner can normally be reached Mon-Fri: 9:00 - 5:00.
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, Terry McKelvey can be reached on (571)272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Sarah Marie Elise SeayExaminer, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655
