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 .
Response to Amendment
The amendments filed on 12/04/2025 have been entered. Claims 2-20 remain pending in the application. The amendments overcome the claim objections and drawing objections set forth in the previous office action dated 08/08/2025, as well as the rejection under 35 USC 101.
Response to Arguments
Applicant's arguments filed 12/04/2025 have been fully considered but they are not persuasive. Applicant argues on page 8 that Bendory fails to teach “wherein the injector alignment sleeve is affixed to an instrument handle from which the ontological visualization shaft extends”. Applicant argues that alignment sleeve 112 is spaced apart from handle 104 as illustrated in FIG 2. Examiner respectfully disagrees because, although not shown in FIG 2, [0069] states “the coupler 112 may be permanently attached to the shaft 106”. Therefore, it is the examiners position that the limitations of the claim have been met and applicants’ argument is not persuasive.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 19-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 depends from claim 1, which is a cancelled claim. For the purpose of examination, claim 19 will be interpreted as intending to depend from claim 2. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 5-16 and 19-20 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 Clifford (US 2008/0262510).
Regarding claim 2, 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 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).
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 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.
Bendory/Imran 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 and 5, Bendory et al./Imran/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 and a first tympanic membrane port device configured to be removably implanted in the tympanic membrane, wherein the first membrane port device defines a port lumen, and wherein at least one of the otologic visualization shaft and the gel injection shaft is configured to pass through the port lumen.
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) and a first tympanic membrane port device (1206) configured to be removably implanted in the tympanic membrane [0111]), wherein the first membrane port device defines a port lumen, and wherein at least one of the otologic visualization shaft and the gel injection shaft is configured to pass through the port lumen (The tool shaft passes through the lumen of the port during delivery as shown in FIG 22).
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 and to comprise a first tympanic membrane port device delivered thereon, 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 a port device as desired for a particular treatment.
Regarding claim 6, Bendory et al./Imran/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 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 at least some intermediate wall in between).
Regarding claim 7, Bendory et al./Imran/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 et al./Imran/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 9, Bendory et al./Imran/Clifford disclose the invention substantially as claimed, as set forth above for claim 8. The device as modified by Imran further discloses the gel injection shaft comprises a needle ([0030] discloses the shaft includes a distal tip is configured to pierce the tympanic membrane 11. According to one or more embodiments, this can be achieved by configuring distal tip 41 to have a pointed, beveled or otherwise tapered shape).
Regarding claim 10, Bendory et al./Imran/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 et al./Imran/Clifford disclose the invention substantially as claimed, as set forth above for claim 1. 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 et al./Imran/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 et al./Imran/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 comprising an anti-inflammatory agent (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 14, Bendory et al./Imran/Clifford disclose the invention substantially as claimed, as set forth above for claim 13. The device as modified by Imran further discloses the therapeutic gel formulation comprising the anti- inflammatory agent comprises first and second functional components mixed to generate a crosslinking reaction of the therapeutic gel formulation (Paragraph [0023] discloses one or more excipients such as gelling agent, preservative, etc. One of ordinary skill would understand components crosslink to form the gel, paragraph [0036-0037]).
Regarding claim 15, Bendory et al./Imran/Clifford disclose the invention substantially as claimed, as set forth above for claim 13. The device as modified by Imran further discloses the therapeutic gel formulation contained within the syringe reservoir comprises the anti-inflammatory agent 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 et al./Imran/Clifford disclose the invention substantially as claimed, as set forth above for claim 13. The device as modified by Imran further discloses the anti-inflammatory agent of the therapeutic gel formulation is provided in an amount sufficient to move passively by diffusion across a membrane of the round window and into the cochlea (Paragraph [0023]).
Regarding claim 19, Bendory et al./Imran/Clifford disclose the invention substantially as claimed, as set forth above for claim 2. The device as modified by Clifford further discloses the distal-most end of the gel injection shaft comprises a curved notch (The rounded ends of the side-cut port are interpreted as a curved notch) oriented toward a longitudinal axis of the visualization shaft (In the device as modified. Also, the gel injection shaft is rotatable such that the notch can be oriented towards the visualization shaft), and wherein the side-cut delivery port is defined at the curved notch (The curved notch defines the side-cut delivery port).
Regarding claim 20, Bendory et al./Imran/Clifford disclose the invention substantially as claimed, as set forth above for claim 19. The device as modified by Imran/Clifford further discloses the proximal actuator is in fluid communication with the gel injection shaft (As taught by Imran above) to dispense the therapeutic gel formulation from the side-cut delivery port (Int eh device as modified by Clifford) while the curved notch is oriented toward the longitudinal axis of the visualization shaft (The device is at least capable of being used in the claimed manner. “While the curved notch is oriented toward the longitudinal axis of the visualization shaft” is interpreted as an intended use of the device and because the claims are directed towards a device and not steps of a method, the device need only be configured for use in the claimed manner).
Claims 4, 17, and 18 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 Clifford (US 2008/0262510), further in view of Piskun (US 7,850,600).
Regarding claim 4, 17, and 18, Bendory et al./Imran/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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771