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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/13/2026 has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the curved notch extending between a first notch end and a second notch end in a direction parallel to a longitudinal axis of the gel injection shaft, wherein the first notch end defines a first notch diameter greater than a second notch diameter of the second notch end” in claim 19 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 04/13/2026, with respect to the rejection(s) of claim(s) 2 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in further view of Sawhney et al. to teach the newly recited limitations regarding the composition of the therapeutic gel formulation.
Applicant further argues on page 9 that it would be inappropriate to use the system of Bendory for injection of a gel substance because Bendory is disclosed as being used for suction. Examiner disagrees because Bendory states in [0066] that tool 128 is described as a suction device but alternatively “may be replaced by any other suitable surgical tool, such as the ones listed previously”. [0063] discloses “In one embodiment, described in detail below, the surgical tool is a suction tube device. In alternative embodiments, however, the tool may be any suitable, small-diameter tool, such as but not limited to a cutting device, a piercing device, an ear tube placement device, a seeker, tweezers, forceps, a speculum, a grasper, or a curette. In the description below of the suction embodiment, the fact that any other suitably sized surgical tool may be substituted for the suction device will not be repeated with the description of every embodiment. Similarly, the devices and methods described below for use in an ear surgery procedure may be used or adapted for use in any other suitable surgical procedure. This, too, will not be repeated with the description of every embodiment”. Therefore, it is understood that the system of Bendory is not limited to use as a suction device and it would not be unreasonable to modify the tool to be used for injection of a therapeutic gel formulation since the field of endeavor (performing a procedure in the ear) supports this use. Therefore, applicants’ argument is not persuasive.
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, 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.
Claims 2, 3, 6-8, 10-13, 15-16 and 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over Bendory et al. (US 2020/0187760) in view of Imran (US 2013/0085476), further in view of Sawhney et al. (US 2009/0017097), further in view of Clifford (US 2008/0262510).
Regarding claims 2, 21, 22 and 23, Bendory et al. discloses a system for treating a round window niche of a cochlea under direct visualization (Abstract, FIG 2), the system comprising: a injector alignment sleeve (112, FIG 2, paragraph [0069-0071], or 212, FIG 4, paragraph [0073]) retaining a treatment tool shaft (128, FIG 2, [0063, 0066] discloses that although illustrated as a suction device, this can be any other suitable surgical tool) and an otologic visualization shaft (106, FIG 2, paragraphs [0066-0073]) in side-by-side parallel relationship (FIG 2 show the parallel relationship at least at the distal ends of the shafts), wherein the injector alignment sleeve (212) is affixed to an instrument handle from which the ontological visualization shaft extends (where 104 is the instrument handle and 212 is affixed thereto , [0069] which states “the coupler 112 may be permanently attached to the shaft 106”), and the otologic visualization shaft is configured to extend distally from a distal end of the injector alignment sleeve (FIG 2 shows distal end 110 of the endoscope extending distally past a distal end 114 of the alignment sleeve) and through a tympanic membrane (The device is at least configured to be positioned through a tympanic membrane, [0061, 0081]), wherein the otologic visualization shaft extends from the injector alignment sleeve such that a distal imaging tip of the otologic visualization shaft (Imaging tip FIG 3, [0072]) is positionable through a tympanic membrane and into a middle ear to visualize a round window niche of a cochlea while the injector alignment sleeve is entirely external from the tympanic membrane (Because the alignment sleeve is slidable along the shaft of the endoscope, [0069], a desired distance between the alignment sleeve and the distal end of the endoscope can be customized. [0081] discloses the device is sized and shaped such that the camera can be used to visualize the middle ear through a natural hole or incision in the tympanic membrane), and wherein the treatment tool shaft extends form the injector alignment sleeve (FIG 2) such that a distal-most end of the treatment tool shaft is located distally of the distal imaging tip of the otologic visualization shaft (Shown in FIGs 5A-5B wherein the treatment tool tip 24 is extendable distal of the imaging tool tip 34).
Bendory is silent regarding the treatment tool shaft being a gel injection shaft and a syringe (or injection device as recited in claim 21) containing the therapeutic gel formation and including proximal actuator in fluid communication with the gel injection shaft to dispense a therapeutic gel formulation, wherein the gel injection shaft is advanceable to the round window niche to dispense the therapeutic gel formulation to the round window niche while the distal imaging tip of the otologic visualization shaft is spaced proximally from the side- cut delivery port of the gel injection shaft to provide visualization of the gel injection shaft.
However, Imran teaches an otologic gel injector device (30, FIGs 1-5, abstract, paragraphs [0028-0033]) having a shaft (4) and a syringe (49, FIG 2, paragraph [0030]) containing a therapeutic gel formulation (50, paragraphs [0040-0042] specifically disclose use of a gel) and including a proximal actuator in fluid communication with the gel injection shaft to dispense the therapeutic gel formulation (The pump of the syringe in interpreted as the actuator, [0030]. [0039] discloses the connection of the syringe to dispense the gel), wherein the gel injection shaft is advanceable to the round window niche to dispense the therapeutic gel formulation to the round window niche (FIG 2, [0029-0031, 0034] discloses Once distal end 41' is situated next to the round window membrane 19, a therapeutic composition 50 is injected through the delivery lumen 42, as shown in FIG. 5), wherein the therapeutic gel formulation comprises an active agent ([0041], therapeutic agent 51) and a polymer composition (gel 50g, [0040-0041]) including a functional polymer (carrier/gelling agent 53), a crosslinker ([0036-0037 and 0041] discloses a crosslinker and modifying the amount of crosslinking in the gel), and water (it is commonly known that a hydrogel formulation is based in tare), wherein the functional polymer and the crosslinker result in a crosslinking reaction that forms a gel ([0041]) configured for extending release of the active agent ([0037, 0042] discloses using the gel formulation properties to control the release rate of the therapeutic agent from the gel) at the round window niche of the cochlea (19, [0037 and 0039]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the otologic injector device of Imran including the therapeutic gel formulation provided therein as the treatment tool in the system of Bendory such that the otologic injector device is received within the alignment sleeve alongside the endoscope, for the purpose of performing a specific treatment within the middle ear that can be visualized by the endoscope while requiring a reduced amount of space to deliver the tools. In the device as modified, the gel injection shaft is configured to dispense the gel to the round window niche while the distal imaging tip of the otologic visualization shaft is spaced proximally from the gel injection shaft to provide visualization of the gel injection shaft because the two tools are adjustable relative to one another and the purpose of the endoscope is to visualize the working end of the treatment tool.
Regarding the therapeutic gel formulation, the device as modified is further silent regarding the functional polymer comprising at least one of pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate and succinimidyl ester in an amount of about 5% to about 15% by weight of the polymer composition and the crosslinker comprising trilysine, or a salt thereof, in an amount of about 0.2% to about 0.6% by weight of the polymer composition.
However, Sawhnet et al. teaches the formulation of a therapeutic hydrogel ([0130-0132]) comprising succinimidyl ester as a functional PEG ([0131]), trilysine as a crosslinker ([0131]), water ([0004]), and a therapeutic agent ([0133]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select succinimidyl ester and trilysine to form the polymer composition of the therapeutic hydrogel, as taught by Sawhney et al., for the purpose of selecting materials commonly known in the art for achieving the formulation of a hydrogel capable of delivering an active agent to the target treatment site within the body. It would have been obvious to one having ordinary skill in the art at the time of filing to select succinimidyl ester in an amount of about 5% to about 15% by weight of the polymer composition and trilysine in an amount of about 0.2% to about 0.6% by weight of the polymer composition as a matter of routine optimization because Imran teaches the composition of the hydrogel should be specifically formulated to achieve the desired therapeutic agent release properties (0040-0042]) and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Bendory/Imran/Sawhney is further silent regarding the gel injection shaft comprising a side-cut delivery port of positioned proximally of the distal- most end of the gel injection shaft.
However, Clifford teaches a material injection shaft (130, FIG 12, [0083]) for delivery of a material to the inside of an ear canal ([0083]) wherein the injection shaft comprising a side-cut delivery port of positioned proximally of the distal- most end of the gel injection shaft (See side cut delivery port in FIG 12 and described in [0083]). Clifford further teaches a side port can be used in addition to or in place of a hole at the distal tip of the shaft and provides the advantage that the use of a side port improves the safety of the device by not delivering the treatment material directly into the canal towards the membrane ([0083].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the port of the gel injection shaft to be positioned as a side cut proximally of the distal most end of the shaft, instead of positioned axially at the distal most end of the shaft, as taught by Clifford, for the purpose of utilizing a port position commonly known in the art for being interchangeable with a distal tip port, with the added benefit of being able to deliver the gel formulation to a treatment site in a more precise manner thereby improving safety and preventing injection of a material in an undesired location or the ear.
Regarding claim 3, Bendory/Imran/Sawhney/Clifford disclose the invention substantially as claimed, as set forth above for claim 2.
Bendory et al. is silent regarding the gel injection shaft is adjustable from a longitudinally straight shape to a curved shape to orient the side-cut delivery port toward the round window niche
However, Bendory teaches in an alternative embodiment of FIG 22 that the treatment tool (Described as a suction shaft however [0063] discloses a suction shaft will be used to describe all embodiments of the treatment tool but the tool can be an alternative device i.e. the gel injection shaft of the device as modified) is adjustable from a longitudinally straight shape to a curved shape (Curved distal end 1204, [0111], understood to also have a straightened configuration for insertion) to orient the side-cut delivery port toward the round window niche ([0111] discloses the curve is advantageous as it allows the used to reach different areas of the tympanic membrane with light spins of the shaft).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the system such that the gel injection shaft is adjustable from a longitudinally straight shape to a curved shape, as taught by the alternative embodiment of Bendory, for the purpose of achieving better control and positioning of the distal end of the device to selectively deliver the tool as desired for a particular treatment.
Regarding claim 6, Bendory/Imran/Sawhney/Clifford disclose the invention substantially as claimed, as set forth above for claim 2. Bendory et al. further discloses the injector alignment sleeve comprises a two-channel alignment sleeve ([0069], each of the two portions 114, 116 is shaped as a tube, also see FIG 4) in which a first lumen (Lumen of 114, 214,) is a primary channel having a first 5diameter (Shown in FIG 4, [0069]) and a second lumen (Lumen formed by 116 or 216) is an auxiliary working channel having a second diameter smaller than the first diameter (Paragraphs [0069 and 0073], FIG 4) and being laterally separated from the primary channel by an intermediate wall portion of the two-channel alignment sleeve (FIG 4 shows a connecting wall between 214, 216. [0069] describes two tube which attach at least some intermediate wall in between).
Regarding claim 7, Bendory/Imran/Sawhney/Clifford disclose the invention substantially as claimed, as set forth above for claim 6. Bendory et al. further discloses the gel injection shaft is movable relative to both the two-channel alignment sleeve and the distal imaging tip portion of the otologic visualization shaft (Because the alignment sleeve is not fixed to either the injection shaft or the visualization shaft, [0073] and FIG 5A-5B).
Regarding claim 8, Bendory/Imran/Sawhney/Clifford disclose the invention substantially as claimed, as set forth above for claim 2. Bendory et al. further discloses the gel injection shaft has an outer diameter that is smaller than an outer diameter of the otologic visualization shaft ([0069] the endoscope attachment portion 114 has a larger diameter than that of the tool attachment portion 116).
Regarding claim 10, Bendory/Imran/Sawhney/Clifford disclose the invention substantially as claimed, as set forth above for claim 2. Bendory et al. further discloses the otologic visualization shaft has an outer diameter larger than an outer diameter of the gel injection shaft ([0069] the endoscope attachment portion 114 has a larger diameter than that of the tool attachment portion 116) and is sized to pass through a first incision through the tympanic membrane ([0081]; camera 30 (equivalent to the endoscope) can be used to visualize the middle ear through a natural hole or incision in the tympanic membrane).
Regarding claim 11, Bendory/Imran/Sawhney/Clifford disclose the invention substantially as claimed, as set forth above for claim 10. Bendory et al. further discloses the outer diameter of the gel injection shaft is sized to pass through a second incision through the tympanic membrane while positioned adjacent to the otologic visualization shaft (The device is at least sized and configured for the injection shaft to pass through an incision of some size, and do so while positioned adjacent to the visualization shaft because the tool shafts are laterally offset and movable relative to one another).
Regarding claim 12, Bendory/Imran/Sawhney/Clifford disclose the invention substantially as claimed, as set forth above for claim 10. Bendory et al. further discloses otologic visualization shaft is sized to pass through the first incision through the tympanic membrane having a size of 0.5 mm to 1.5 mm ([0012] discloses the suction shaft, which is modified to have injecting function, has an outer diameter of no more than 1.1mm, therefore it is sized to fit within an incision within the claimed range).
Regarding claim 13, Bendory/Imran/Sawhney/Clifford disclose the invention substantially as claimed, as set forth above for claim 10. The device as modified by Imran further discloses the syringe includes a reservoir containing the therapeutic gel formulation (FIG 2 shows gel formulation 50, 51 received within syringe 49. It is commonly understood that ta syringe hold liquid within a reservoir for delivery).
Regarding claim 15, Bendory/Imran/Sawhney/Clifford disclose the invention substantially as claimed, as set forth above for claim 13. The device as modified by Imran further discloses the active agent is selected from the group consisting of: hydrocortisone, hydrocortisone acetate, dexamethasone (Paragraphs [0024-0026]), dexamethasone 21-phosphate, fluocinolone, medrysone, prednisolone, prednisolone 21-phosphate, prednisolone acetate, fluoromethalone, betamethasone, and triamcinolone.
Regarding claim 16, Bendory/Imran/Sawhney/Clifford disclose the invention substantially as claimed, as set forth above for claim 13. The device as modified by Imran further discloses the active agent is provided in an amount sufficient to move passively by diffusion across round window membrane and into the cochlea (Paragraph [0023]).
Regarding claim 24, Bendory/Imran/Sawhney/Clifford disclose the invention substantially as claimed, as set forth above for claim 23. The device as modified by Sawhney further discloses the carrier comprises aqueous media (aqueous solution [0035, 0051, 0055]) and hyaluronic acid ([0039]).
Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bendory et al. (US 2020/0187760) in view of Imran (US 2013/0085476), further in view of Sawhney et al. (US 2009/0017097), further in view of Clifford (US 2008/0262510), further in view of Piskun (US 7,850,600).
Regarding claim 4 and 17, Bendory et al./Imran/Sawhney/Clifford disclose the invention substantially as claimed, as set forth above for claim 2 and 3.
The device as modified is silent regarding the gel injection shaft is selectively adjustable from a longitudinally straight shape to the curved shape comprising a first curved portion and a second curved portion by manipulating one or more control members slidably coupled with the gel injection shaft, wherein the first curved portion and the second curved portion are in a same plane and curve in opposing directions.
However, Piskun teaches a shaft (80, FIG9) which is selectively adjustable from a longitudinally straight shape (Not shown but there exists a state where each segment of the shaft is aligned such that it forms a straight shape) to a curved shape (FIG 9) comprising a first curved portion (Col 11 lines 35-40 “Proximal end segments 84, 86 and 88 form a proximal shaft portion 100 that is independently bendable to form, for example, a C shaped configuration”) and a second curved portion (Col 11 lines 40-46 “Distal end segments 90, 92 and 94 form a distal shaft portion 108 that is independently bendable to form, for example, a C shaped configuration.”) by manipulating one or more control members slidably coupled with the shaft (Col 11 line 54-col 12 line 3 disclose the actuation of the curved portions), wherein the first curved portion and the second curved portion are in a same plane and curve in opposing directions (As shown in FIG 9).
Therefore, it would have been obvious to modify the gel injector shaft to be bendable to form a first curved portion and a second oppositely directed curved portion, by means of a control member positioned within the shaft, as taught by Piskun, for the purpose of achieving the predictable result of reliably controlling the bending and straightening of the shaft depending on the stage of inserting into the ear anatomy and the desired positioning.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Bendory et al. (US 2020/0187760) in view of Imran (US 2013/0085476), further in view of Sawhney et al. (US 2009/0017097), further in view of Clifford (US 2008/0262510), further in view of Meyer (US 2014/0364836).
Regarding claim 25, Bendory et al./Imran/Sawhney/Clifford disclose the invention substantially as claimed, as set forth above for claim 23.
The device as modified is silent regarding the carrier comprises P407.
However, Meyer teaches in the same field of endeavor a hydrogel for therapeutic delivery to treat an inner ear (abstract) wherein the gel formulation comprises P407 as a carrier ([0033] discloses the gel forming biocompatible polymer being a poloxamer and claim 30 specifically teaches P407).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select P407 as a carrier of the gel, as taught by Meyer, for the purpose of selecting a gel forming polymer material commonly known in the art for being biocompatible and providing for effective release within the round window niche ([0095]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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