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 .
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, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. PCT/US2021/044155, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. No limitations in any of the current claims are supported in the prior-filed application. It appears that applicant may have mis-identified the prior-filed application, and may have intended to refer to application PCT/US2021/055155.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-8 and 17-23) in the reply filed on 23 July 2025 is acknowledged.
Claims 9-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 23 July 2025.
Claims 1-8 and 17-23 (misnumbered as 17-21, with two 18s and two 19s) are under current consideration.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claims 18-21 been renumbered 20-23.
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 17-20 and 23 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.
The term “shell-like” in claims 17 and 19 is a relative term which renders the claim indefinite. The term “shell-like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what “like” is intended to convey. See e.g., MPEP 2173.05(b)(III)(E). Claims 18 and 20 are rejected as depending therefrom without remedying such deficiency.
Claim 23 recites the limitation "the liposomal nanoparticle" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
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)(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.
Claim(s) 1-8 and 17-23 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Joshi et al. (US 2020/0345630 A1; published 05 November 2020; filed 27 April 2020).
Regarding claim 1, Joshi et al. discloses a method of treating a subject having otitis media associated with a middle ear infection, the method comprising topically applying into the ear canal of an ear of the subject an aqueous suspension composition comprising nanoparticles and a pharmaceutically acceptable aqueous carrier, wherein the nanoparticles comprise a therapeutically effective amount of one or more therapeutic agents; whereby, the topically applied nanoparticles diffuse through the ear's tympanic membrane, thereby delivering the one or more therapeutic agents to the middle ear and treating the otitis media (claim 1), which reads on the claimed method of treating a disorder in a middle ear of a patient, comprising: Delivering a nanoparticle having a therapeutic agent into the ear canal of the patient; Penetrating without damaging the tympanic membrane with the nanoparticle; and Delivering the agent to the middle ear of the patient for the treatment of a disorder of the ear of the patient. Joshi et al. also discloses that the delivery is via ear drop (paragraph [0053]), which reads on the claimed delivery of an ear drop.
Regarding claim 2, Joshi et al. discloses that the one or more therapeutic agents comprises an anti-infection agent, and anti-inflammatory agent, and an anti-biofilm agent (claim 17), which reads on the claimed multiple therapeutic agents delivered by the same nanoparticle.
Regarding claim 3, Joshi et al. discloses that the nanoparticles comprise a therapeutically effective amount of one or more therapeutic agents and that the delivery of the one or more therapeutic agents to the middle ear treats the otitis media (claim 1), which reads on the claimed nanoparticle adapted for treatment of otitis media.
Regarding claim 4, Joshi et al. discloses that the otitis media is chronic otitis media with effusion (paragraph [0011]), which reads on the claimed nanoparticle adapted for changing properties of fluid as part of a treatment of otitis media with effusion, given that the effusion of Joshi et al. is treated in the method thereof and thus the middle ear effusion fluid thereof necessarily changes properties / is ameliorated by the nanoparticles as it is treated.
Regarding claim 5, Joshi et al. discloses that the otitis media is chronic otitis media with effusion (paragraph [0011]), which reads on the claimed nanoparticle adapted for eradication of infection in fluid as part of a treatment of chronic otitis media, given that the effusion of Joshi et al. is treated in the method thereof and thus the middle ear effusion fluid thereof necessarily has fluid infection thereof eradicated by the nanoparticles as it is treated.
Regarding claim 6, Joshi et al. discloses that the otitis media is chronic otitis media with effusion (paragraph [0011]), which reads on the claimed detecting a presence of a fluid, given that such effusion/fluid necessarily is detected in identifying the otitis media as otitis media with effusion, and the claimed imaging agent comprising an inflammation targeted probe that will fluoresce merely further limits the imaging agent but the imaging agent is not a required limitation of the claim given that claim 1 requires an imaging agent, diagnostic agent, or therapeutic agent.
Regarding claim 7, the claimed probe will fluoresce within the visible, NIR and short-wave infrared spectrum merely further limits the imaging agent but the imaging agent is not a required limitation of the claim given that claim 1 requires an imaging agent, diagnostic agent, or therapeutic agent.
Regarding claim 8, Joshi et al. discloses that the nanoparticles comprise liposomes (claim 3) comprising lipids (claim 4), which reads on the claimed nanoparticle being lipid-based or a liposomal formulation.
Regarding claim 17, Joshi et al. discloses that the nanoparticles comprise liposomes (claim 3) comprising lipids (claim 4) wherein liposomes are bi-layer vesicles (paragraph [0016]), reading on the claimed nanoparticle comprising a vesicular structure composed of lipids arranged in a shell-like bilayer. Joshi et al. also discloses that the nanoparticles diffuse through the ear's tympanic membrane (claim 1), reading on the claimed formulated for trans-tympanic membrane delivery, and Joshi et al. discloses that the nanoparticles comprise a therapeutically effective amount of one or more therapeutic agents (claim 1), reading on the claimed therapeutic agent loaded onto the structure.
Regarding claim 18, Joshi et al. discloses that the lipids are selected from dihexadecylphosphate (DhP), phosphatidyl inositols, a phosphatidyl serine, a phosphatidyl glycerols, a phosphatidic acid, and diphosphatidyl glycerol (claim 9), reading on the claimed lipids comprising phospholipids.
Regarding claim 19, Joshi et al. discloses that the nanoparticles comprise liposomes (claim 3) comprising lipids (claim 4) wherein liposomes are bi-layer vesicles (paragraph [0016]), reading on the claimed lipids comprising a hydrophilic surface and core and a hydrophobic interior of the shell-like bilayer, given that liposomes inherently have a hydrophilic surface and core and a hydrophobic interior of the shell-like bilayer.
Regarding claim 20, Joshi et al. discloses preparation of ciprofloxacin therapeutic agent loaded into the liposomes (paragraph [0048]), which reads on the claimed therapeutic agent loaded within an interior.
Regarding claim 21, Joshi et al. discloses delivery of one or more therapeutic agents to the middle ear (claim 1), which reads on the claimed delivered to deliver drugs to the middle ear, and Joshi et al. discloses that the therapeutic agent is an antimicrobial agent (claim 14), which reads on the claimed anti-microbial drugs, and Joshi et al. also discloses that the delivery is via ear drop (paragraph [0053]), which reads on the claimed ear drop.
Regarding claim 22, Joshi et al. discloses treatment of a condition of the inner ear (paragraph [0028]), which reads on the claimed delivery of therapeutic agents to the inner ear.
Regarding claim 23, Joshi et al. discloses that the nanoparticles comprise one or more therapeutic agents (claim 1) and that the one or more therapeutic agents comprises an anti-infection agent, and anti-inflammatory agent, and an anti-biofilm agent (claim 17), which reads on the claimed nanoparticle comprising a formulation comprising multiple compounds loaded simultaneously on or within the same nanoparticle, and Joshi et al. discloses that the nanoparticles comprise liposomes (claim 3), which reads on the claimed liposomal nanoparticle.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617