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 .
Acknowledgments
In the reply, filed on June 4, 2026, Applicant amended claims 1-2, 6, 10-12, 14, 16, and 20.
In the non-final rejection of April 7, 2026, Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 1-2, 6, 11-12, 14, 16, and 20. Applicant amended claims 1-2, 6, 11-12, 14, 16, and 20. Objection is withdrawn.
Examiner rejected claims 1-21 under 35 U.S.C. 112(b). Applicant persuasively argued against the rejections of claim 1 (Remarks, page 11). Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see page 10, filed June 4, 2026, with respect to the rejection(s) of claim 10 under de Juan et al (US 2022/0221700) 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 Therefore, the rejection has been withdrawn.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 view of Sacherman et al (US 2022/0126028), and further in view of de Juan et al (US 2022/0221700).
Claim Objections
Claims 2, 10, 15, and 21 are objected to because of the following informalities:
In regards to claim 2, lines 2-3, “its entire length” should be changed to “an entire length of the distal tip region”.
In regards to claim 10, line 2, “the gel delivery” should be changed to “the gel delivery system”.
In regards to claim 15, line 3, “the round window niche” should be changed to “a round window niche”.
In regards to claim 21, line 3, “a hole in a mastoid bone” should be changed to “the hole in the mastoid bone”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sacherman et al (US 2022/0126028), and further in view of de Juan et al (US 2022/0221700).
In regards to claim 10, Sacherman et al teaches a gel delivery system (Figures 23A-24) for treatment at a cochlear implant lead insertion site of a cochlea, the gel delivery comprising:
a transmastoid injector tool (930) including: a treatment gel delivery shaft (921d) positionable through a transmastoid pathway toward a cochlear implant lead to deposit a treatment gel at the cochlear implant lead insertion site of the cochlea; a reservoir (931) containing said treatment gel comprising a polymer gel composition (933) including water (paragraph [0159]); and a user-adjustable actuator (107) to urge the treatment gel from the reservoir toward a distal port (at 903) of the treatment gel delivery shaft that is sized to deposit a dosage of the treatment gel to seal the cochlear implant lead insertion site at a round window niche of the cochlea
a visualization tool (924/925a) configured to provide simultaneous visualization of both a distal tip region of the treatment gel delivery shaft and the treatment gel deposited at the cochlear implant lead insertion site of the cochlea
wherein the distal tip region of the treatment gel delivery shaft includes the distal port and is sized to advance through the transmastoid pathway such that the distal port of the treatment gel delivery shaft is positionable proximate to the cochlear implant lead at the cochlear implant lead insertion site (Figures 23A-23C)
wherein the visualization tool comprises a visualization shaft (924), the transmastoid injector tool further comprising a handle (901) connected to both the treatment gel delivery shaft and the visualization shaft such that both the treatment gel delivery shaft and the visualization shaft extend distally from the handle
wherein the treatment gel delivery shaft and the visualization shaft advanceable through the transmastoid pathway behind an ear such that the distal port of the treatment gel delivery shaft is proximate to the cochlear implant lead to deposit the treatment gel at the cochlear implant lead insertion site of the cochlea (Figures 23A-23C)
wherein the distal port of the treatment gel delivery shaft is positioned distally of the visualization shaft so that the visualization shaft is configured to provide simultaneous imaging of both the treatment gel delivery shaft and the treatment gel deposited at the cochlear implant lead insertion site of the cochlea (Figures 23A-23C)
wherein the treatment gel delivery shaft and the visualization shaft are side-by-side shafts (921d/924) being fixedly mounted to the handle in a stationary position relative to one another and extending distally from the handle such that the distal port of the treatment gel delivery shaft is positioned distally of the visualization shaft (Figure 23A)
Sacherman et al is silent about the polymer gel composition including a functional polymer of about 5% to about 15% by weight of the polymer gel composition, and a crosslinker of about 0.2% to about 0.6% by weight of the polymer gel composition, as Sacherman et al only teaches the polymer gel composition including water and a polymer (paragraph [0159]). deJuan et al teaches a gel delivery system (Figures 5, 7, 34-37, 41, 43) comprising: a reservoir (1010/1020) containing a treatment gel comprising a polymer gel composition (100) including water (paragraph [0176]), a functional polymer of about 5% to about 15% by weight of the polymer gel composition (paragraph [0176]), and a crosslinker of about 0.2% to about 0.6% by weight of the polymer gel composition (paragraph [0176]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the polymer gel composition, of the system of Sacherman et al, to include water, a functional polymer of about 5% to about 15% by weight of the polymer gel composition, and a crosslinker of about 0.2% to about 0.6% by weight of the polymer gel composition, as taught by de Juan et al, as such will allow for a crosslinking reaction to occur to form a gel by mixing of the formulation components at patient bedside and immediately delivered into the cochlea (paragraphs [0173][0176]).
Allowable Subject Matter
Claims 1-9 and 14-21 are allowed.
In regards to independent claim 1, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a gel delivery system, as claimed, specifically including a cochlear implant lead configured to extend through a transmastoid pathway and penetrate through a cochlear implant lead insertion site of a cochlea; and a transmastoid injector tool including: a treatment gel delivery shaft having a distal tip region to fit adjacent to the cochlear implant lead through a hole in a mastoid bone to deposit a treatment gel along an exterior of the cochlear implant lead at the cochlear implant lead insertion site of the cochlea.
de Juan et al (US 2022/0221700) teaches a gel delivery system (Figures 5, 7, 34-37, 41, 43), comprising: a transmastoid injector tool (800) including: a treatment gel delivery shaft (810) having a distal tip region (812) to fit adjacent to the cochlear implant lead through a hole in a mastoid bone to deposit a treatment gel at the cochlear implant lead insertion site of the cochlea (Figure 36).
However, de Juan et al does not teach a cochlear implant lead configured to extend through a transmastoid pathway and penetrate through a cochlear implant lead insertion site of a cochlea; and the treatment gel delivery shaft to deposit the treatment gel along an exterior of the cochlear implant lead.
Thus, independent claim 1 is allowed. Dependent claims 2-9 and 14-21 are allowed by virtue of being dependent upon independent claim 1.
Claims 11-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to dependent claim 11, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a gel delivery system for treatment at a cochlear implant lead insertion site of a cochlea, as claimed, specifically including wherein the visualization tool further comprises a tip-mounted image capture device fixedly mounted at a distal end of the visualization shaft and oriented toward the distal port of the treatment gel delivery shaft so that the tip-mounted image capture device is configured to provide the simultaneous imaging of both the treatment gel delivery shaft and the treatment gel deposited at the cochlear implant lead insertion site of the cochlea.
Sacherman et al teaches a gel delivery system (Figures 23A-24) for treatment at a cochlear implant lead insertion site of a cochlea.
However, Sacherman et al does not teach wherein the visualization tool further comprises a tip-mounted image capture device fixedly mounted at a distal end of the visualization shaft and oriented toward the distal port of the treatment gel delivery shaft so that the tip-mounted image capture device is configured to provide the simultaneous imaging of both the treatment gel delivery shaft and the treatment gel deposited at the cochlear implant lead insertion site of the cochlea, as Sacherman et al instead teaches wherein the visualization tool (924/925a) further comprises an optic line 925a oriented toward the distal port (at 903) of the treatment gel delivery shaft (921d) so that the optic line 925a is configured to provide the simultaneous imaging of both the treatment gel delivery shaft and the treatment gel (933) deposited at the cochlear implant lead insertion site of the cochlea.
Thus, dependent claim 11 is objected to as being dependent upon a rejected base claim 10, but would be allowable if rewritten in independent form including all of the limitations of the base claim 10. Dependent claims 12-13 are objected to by virtue of being dependent upon dependent claim 11.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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