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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/02/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the preliminary amendment filed on 01/17/2024. As directed by the amendment: claim 1-236 have been cancelled.
Thus, claims 237-261 are pending in this application.
Specification
The abstract of the disclosure is objected to because the abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b).
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
Para 0201, line 5, “the the therapeutic agent” should read “ the therapeutic agent”.
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.
Claims 237-239, 241, 242, 244-246, 250, 254 and 260 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arenberg (US 5421818 A).
Regarding claim 237, Arenberg discloses a method (10, claim 10, fig 2) comprising: administering a drug formulation (39) to the middle ear of an ear (149) by depositing the drug formulation into a conduit (24/38) positioned in the ear (figs 2 and 9, col 14, lines 66-68 and col 15, lines 1-16, claim 10), wherein the drug formulation comprises a therapeutic agent (abstract and col 2, lines 46-56), and the conduit (24/30) comprises: a proximal end (20), the proximal end having a proximal end radius (see fig 1); a distal end (34) opposite the proximal end (fig 1), the distal end having a distal end radius (figs 1-2); an inner surface (inner surface of conduit 24 and 38) connecting the proximal end and the distal end (see figs 1-2), at least a portion of the inner surface comprising a conical or curved geometry extending at least partially between the proximal end and the distal end (fig 2, portion of cavity 38 is curved, thus at least a portion of inner portion extending at least partially between the proximal end and the distal end); an outer surface (outer surface of 12) connecting the proximal end and the distal end (figs 1-2), and the conduit is configured to allow a selective transport of the therapeutic agent from the proximal end to the distal end of the conduit (col 12, lines 27-39 and col 16, lines 53-68).
Regarding claim 238, Arenberg discloses the method of claim 237, wherein the proximal end is disposed in an ear canal of the ear and the distal end is disposed in the middle ear (fig 9, said proximal end is in an ear canal and said distal end is in middle ear and col 19, lines 49-68).
Regarding claim 239, Arenberg discloses the method of claim 237, wherein a shape of the conduit is selected from a group consisting of a tube, a shell, a channel, a hose, a pipe, a cone, an oval, and a combination thereof (see figs 1 and 2, conduit is a combination of tube and an oval shape).
Regarding claim 241, Arenberg discloses the method of claim 237, wherein the conduit is configured to be self- supporting, bendable, shape retaining, or deformable (col 3, lines 34-40 and col 6, lines 60-65).
Regarding claim 242, Arenberg discloses the method of claim 237, wherein the conduit comprises one or more of nano-sized, micro-sized, or millimeter-sized pores (46, col 5, lines 30-40).
Regarding claim 244, Arenberg discloses the method of claim 237, wherein the conduit is configured to transport a biofluid of the middle ear from the distal end to the proximal end of the conduit (col 6, lines 6-26 and col 17, lines 1-8).
Regarding claim 245, Arenberg discloses the method of claim 237, wherein the distal end radius is equal to or larger than the proximal end radius (figs 1 and 2).
Regarding claim 246, Arenberg discloses the method of claim 237, wherein the drug formulation further comprises one or more of a priming agent and an activating agent, wherein the priming agent modifies one or more properties of the conduit from a first configuration to a second configuration either upon activation of the priming agent or caused by one or more of wetting and infusion of the priming agent (col 11, lines 56-66- delivery of fluid or gas causes said conduit to expand meaning it changes from a first configuration to a second configuration), and wherein the activating agent is capable of releasing the therapeutic agent toward a portion of the inner surface of the conduit upon activation of the activating agent (col 12, lines 3-26).
Regarding claim 250, Arenberg discloses the method of claim 237, wherein the therapeutic agent comprises a solution, a suspension, or a combination thereof (col 15, lines 47-64 and col 21, lines 12-33).
Regarding claim 254, Arenberg discloses the method of claim 237, wherein the therapeutic agent comprises an ion channel modulator selected from a group consisting of ampicillin, calcium channel blockers, diltiazem, nifedipine, verapamil, drugs that act on sodium channels, riluzole, dextromethorphan, lidocaine, and a combination thereof (col 21, lines 25-29, Sodium chloride functions as an ion channel modulator).
Regarding claim 260, Arenberg discloses the method of claim 237, wherein the conduit comprises a material selected from a group consisting of silicone, polysiloxane, or a combination thereof (col 14, lines 1-7).
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 (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 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.
Claim 240 is rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US 5421818 A) in view of Bays et al (US 4650488 A).
Regarding claim 240, Arenberg discloses the limitations of claim 237 as discussed above but fails to teach said conduit comprises one or more flanges.
However, Bays et al disclose method and device for insertion between the middle ear and the outer ear (abstract and fig 1) comprise a conduit comprising one or more flanges (12, 14, fig 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the conduit of Arenberg to comprise one or more flanges as taught by Bays et al. This would provide the benefit of having a conduit that can easily be gripped during insertion (col 3, lines 26-30).
Claim 243 is rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US 5421818 A) in view of Avior (US 8147545 B2).
Regarding claim 243, Arenberg discloses the limitations of claim 237 as discussed above but fails to teach said conduit is configured to prevent transport of an infectious material from the proximal end to the distal end of the conduit.
However, Avior discloses method and device for insertion into an ear (abstract and figs 1-2) comprise a conduit (1) comprising a distal end (4) and a proximal end (3) wherein the conduit is configured to prevent transport of an infectious material from the proximal end to the distal end of the conduit (col 10, lines 25-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the conduit of Arenberg to be configured to prevent transport of an infectious material from the proximal end to the distal end of the conduit as taught by Avior. This would provide the benefit of preventing ear infection which may cause pain and/or fever (col 10, lines 25-30).
Claims 247-249 and 257-259 are rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US 5421818 A) in view of Aizenberg (US 20150152270 A1).
Regarding claim 247, Arenberg discloses the limitations of claim 237 as discussed above but fails to teach said conduit includes a lubricating fluid formed over at least a portion of the inner surface and the outer surface of the conduit.
However, Aizenberg discloses a conduit (para 0046) wherein the conduit includes a lubricating fluid formed over at least a portion of the inner surface and the outer surface of the conduit (para 0046 and 0210).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the conduit of Arenberg to include a lubricating fluid formed over at least a portion of the inner surface and the outer surface of the conduit as taught by Aizenberg. This would provide the benefit of possessing the ability to form a smooth surface when provided over the roughened surface and create defect-free surface that can reduce contact angle hysteresis and adhesion of external matter (para 0031 and 0137).
Regarding claim 248, Arenberg in view of Aizenberg discloses the method of claim 247,
Aizenberg further discloses wherein the lubricating fluid comprises a silicone oil (para 0158 and 0173).
Regarding claim 249, Arenberg in view of Aizenberg discloses the method of claim 247,
Aizenberg further discloses wherein the lubricating fluid comprises a fluid selected from a group consisting of fluocinolone acetonide oil, fully or partially fluorinated hydrocarbons, tertiary perfluoroalkylamines, perfluoroalkylsulfides, perfluoroalkylsulfoxides, perfluoroalkylethers, perfluorocycloethers, perfluoropolyethers, perfluoroalkylphosphines, or perfluoroalkyl phosphine oxides, or a combination thereof (para 0159 and 0256).
Regarding claim 257, Arenberg discloses the limitations of claims 237 and 246 as discussed above but fails to teach the priming agent comprises a lubricating liquid.
However, Aizenberg discloses a lubricating fluid which have an affinity for the polymer such that the liquid causes the polymer to swell and absorb the liquid (para 0153 and 0155).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the priming agent of Arenberg to comprise a lubricating liquid as taught by Aizenberg. This would provide the benefit of having a lubricating liquid that is readily absorbed into the conduit and possesses the ability to form an ultra-smooth surface over the conduit and modifies one or more properties of the conduit from a first configuration to a second configuration caused by one or more of wetting and infusion of the priming agent (para 0153 and 0155).
Regarding claim 258, Arenberg in view of Aizenberg discloses the method of claim 257,
Aizenberg further discloses wherein the lubricating fluid comprises a silicone oil (para 0158 and 0173).
Regarding claim 259, Arenberg in view of Aizenberg discloses the method of claim 257,
Aizenberg further discloses wherein the lubricating fluid comprises a fluid selected from a group consisting of fluocinolone acetonide oil, fully or partially fluorinated hydrocarbons, tertiary perfluoroalkylamines, perfluoroalkylsulfides, perfluoroalkylsulfoxides, perfluoroalkylethers, perfluorocycloethers, perfluoropolyethers, perfluoroalkylphosphines, or perfluoroalkyl phosphine oxides, or a combination thereof (para 0159 and 0256).
Claim 251 is rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US 5421818 A) in view of Goldfarb et al (US 20190321610 A1).
Regarding claim 251, Arenberg discloses the limitations of claim 237 as discussed above and further disclose wherein the therapeutic agent comprises an antimicrobial agent (col 21, lines 12-19) but fails to teach the antimicrobial or antifungal agent selected from a group consisting of ciprofloxacin, ofloxacin, clotrimazole, miconazole, bicyclic heteroarylsubstituted imidazole compound, and a combination thereof.
However, Goldfarb et al disclose devices and methods are described for delivering a therapeutic substance to an ear of a subject (para 0002) wherein the therapeutic agent comprises an antimicrobial selected from a group consisting of ciprofloxacin (para 0049).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the antimicrobial agent of Arenberg to be selected from a group consisting of ciprofloxacin as taught by Goldfarb et al. This would provide the benefit of treating ear infection which works well to kill bacteria (para 0049).
Claims 252 and 253 are rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US 5421818 A) in view of Sacherman et al (US 20190321611 A1).
Regarding claim 252, Arenberg discloses the limitations of claim 237 as discussed above and further disclose wherein the therapeutic agent comprises an antiviral agent (col 21, lines 12-19) but fails to teach the antiviral agent selected from a group consisting of acyclovir, famciclovir, valacyclovir, and a combination thereof.
However, Sacherman et al disclose devices and methods are described for delivering a therapeutic substance to an ear of a subject (para 0007) wherein the therapeutic agent comprises an antiviral agent selected from a group consisting of acyclovir (para 0124).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the antiviral agent of Arenberg to be selected from a group consisting of acyclovir as taught by Sacherman et al. This would provide the benefit of treating ear infection which works well to kill bacteria for early treatment (para 0124).
Regarding claim 253, Arenberg discloses the limitations of claim 237 as discussed above and further disclose wherein the therapeutic agent comprises a steroid (col 21, lines 12-16) but fails to teach the steroid selected from a group consisting of corticosteroids, dexamethasone, prednisone, cortisone, and a combination thereof.
However, Sacherman et al disclose devices and methods are described for delivering a therapeutic substance to an ear of a subject (para 0007) wherein the therapeutic agent comprises a steroid selected from a group consisting of dexamethasone (para 0124 and 0125).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the steroid of Arenberg to be selected from a group consisting of dexamethasone as taught by Sacherman et al. This would provide the benefit of having an anti-inflammatory for the treatment of Meniere's Disease (para 0124-25).
Claims 255 and 256 are rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US 5421818 A) in view of Savel et al (US 20200397907 A1).
Regarding claim 255, Arenberg discloses the limitations of claim 237 as discussed above but fails to teach the therapeutic agent is selected from a group consisting of toll-like receptor inhibitors, TNF-a inhibitors, interleukin inhibitors, calcineurin inhibitors, and a combination thereof.
However, Savel et al disclose devices and methods are described for delivering a therapeutic substance to an ear of a subject (abstract) wherein the therapeutic agent is selected from a group consisting of toll-like receptor inhibitors, TNF-a inhibitors, interleukin inhibitors, calcineurin inhibitors, and a combination thereof (para 0271 and 0309).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the therapeutic agent of Arenberg to be selected from a group consisting of toll-like receptor inhibitors, TNF-a inhibitors, interleukin inhibitors, calcineurin inhibitors, and a combination thereof as taught by Savel et al. This would provide the benefit of having immunomodulator compositions and formulations to treat otic diseases or conditions (para 0271).
Regarding claim 256, Arenberg discloses the limitations of claim 237 as discussed above but fails to teach the therapeutic agent comprises a surfactant selected from a group consisting of phospholipids, cholesterol, and a combination thereof.
However, Savel et al disclose devices and methods are described for delivering a therapeutic substance to an ear of a subject (abstract) wherein the therapeutic agent comprises a surfactant selected from a group consisting of phospholipids or cholesterol (para 0798 and 0856).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the therapeutic agent of Arenberg to comprise a surfactant selected from a group consisting of phospholipids, cholesterol, and a combination thereof as taught by Savel et al. This would provide the benefit of having compositions and formulations that are useful and enhance physical stability (para 0796).
Claim 261 is rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US 5421818 A) in view of Arenberg et al (US 20040172005 A1).
Regarding claim 261, Arenberg discloses the limitations of claim 237 as discussed above but fails to teach the conduit comprises a material selected from a group consisting of fluoropolymer, polyvinyl fluoride, polytetrafluorethylenes, fluoroplastics, polyvinylidene fluoride, polytetrafluoroethylene, and a combination thereof.
However, Arenberg et al disclose devices and methods are described for delivering a therapeutic substance to an ear of a subject (0017) comprises a conduit (13) wherein the conduit comprises a material selected from a group consisting of fluoropolymer, polyvinyl fluoride, polytetrafluorethylenes, fluoroplastics, polyvinylidene fluoride, polytetrafluoroethylene, and a combination thereof (para 0059-60).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the conduit of Arenberg to comprise a material selected from a group consisting of fluoropolymer, polyvinyl fluoride, polytetrafluorethylenes, fluoroplastics, polyvinylidene fluoride, polytetrafluoroethylene, and a combination thereof as taught by Arenberg et al. This would provide the benefit of having biocompatible polymeric materials which are hydrophobic and which should remain chemically and physically stable when in implanted into an ear (para 0057 and 0059).
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /DUNG T ULSH/Examiner, Art Unit 3783