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, 5, 8, 10, 12-14, and 16-18.
Applicant added new claims 21-23.
In the non-final rejection of March 25, 2026, Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 1, 12, 13, and 17. Applicant amended claims 1, 12, 13, and 17; however, Applicant did not address all of the objections. Objection is maintained.
Claim Objections
Claims 1, 14, and 17 are objected to because of the following informalities:
In regards to claim 1, line 2, “a cochlea, comprising:” should be changed to “a cochlea, the system comprising:”.
In regards to claim 14, line 2, “a cochlea, comprising:” should be changed to “a cochlea, the system comprising:”.
In regards to claim 17, line 2, “a proximal end” should be changed to “the proximal end”.
In regards to claim 17, line 5, “a distal end” should be changed to “the distal end”.
In regards to claim 17, line 6, “second peak” should be changed to “the second peak”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erickson et al (WO 2023/055551).
In regards to claim 1, Erickson et al teaches a system (Figures 8-9) for delivering a self-gelling therapeutic formulation at a cochlear implant lead insertion site of a cochlea, comprising:
a transmastoid injector tool (Figures 8-9) having both a therapeutic gel delivery shaft (330) and a visualization shaft (420) positionable adjacent to a cochlear implant lead in a transmastoid surgical opening such that a distal port of the therapeutic gel delivery shaft is configured to deposit the self-gelling therapeutic formulation at the cochlear implant lead insertion site of the cochlea (page 11, lines 23-28)(page 3, lines 24-26), the transmastoid injector tool comprising:
an elongate handle (310) that both defines a maximum lateral width of the transmastoid injector tool and extends longitudinally for a majority of an overall longitudinal length of the transmastoid injector tool, wherein both the therapeutic gel delivery shaft and the visualization shaft extend distally from a distal end of the elongate handle for a minority of the overall longitudinal length of the transmastoid injector tool (Figure 8)
a luer connector (342) in fluid communication with a proximal end of the elongate handle to connect with a treatment actuator device configured to deliver the self-gelling therapeutic formulation through a gel delivery lumen of the therapeutic gel delivery shaft and out of the distal port of the therapeutic gel delivery shaft toward the cochlear implant lead insertion site of the cochlea (page 11, lines 23-28)(page 3, lines 24-26)
wherein the distal port of the therapeutic gel delivery shaft is positioned distally of the visualization shaft so that the visualization shaft is configured to provide simultaneous imaging of both the therapeutic gel delivery shaft and the self-gelling therapeutic formulation deposited at the cochlear implant lead insertion site of the cochlea (Figure 8)
In regards to claim 2, Erickson et al teaches wherein the therapeutic gel delivery shaft is sized to extend through the transmastoid surgical opening behind an ear so that the distal port of the therapeutic gel delivery shaft is adjacent the cochlear implant lead insertion site at the cochlea when the distal port of the therapeutic gel delivery shaft deposits the self-gelling therapeutic formulation to seal the cochlear implant lead insertion site (Figure 8)(page 11, lines 23-28)(page 3, lines 24-26).
In regards to claim 3, Erickson et al teaches wherein the distal port of the therapeutic gel delivery shaft is further configured to deposit the self-gelling therapeutic formulation at the cochlear implant lead insertion site of the cochlea subsequent to the cochlear implant lead being implanted within the cochlea (Figure 8)(page 11, lines 23-28)(page 3, lines 24-26).
In regards to claim 4, Erickson et al teaches wherein the distal port of the therapeutic gel delivery shaft is configured to deposit the self-gelling therapeutic formulation at the cochlear implant lead insertion site prior to the cochlear implant lead being implanted within the cochlea (Figure 8)(page 11, lines 23-28)(page 3, lines 24-26).
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.
Claims 5-7 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al, as applied to claim 1 above, and further in view of de Juan et al (US 2022/0221700).
In regards to claim 5, Erickson et al teaches a reservoir containing the self-gelling therapeutic formulation for communication through the luer connector in fluid communication with the proximal end of the elongate handle of the transmastoid injector tool (page 11, lines 23-28)(page 3, lines 24-26); however, Erickson et al is silent about the reservoir containing the self-gelling therapeutic formulation comprising: a first functional polymer, a crosslinker, and an anti-inflammatory therapeutic agent configured to provide a sustained release into the cochlea via the cochlear implant lead insertion site of the cochlea. de Juan et al teaches a system (Figures 45-46) comprising a reservoir containing a self-gelling therapeutic formulation comprising: a first functional polymer, a crosslinker, and an anti-inflammatory therapeutic agent configured to provide a sustained release into a cochlea via a cochlear implant lead insertion site of the cochlea (paragraphs [0173][0174][0176][0180])(claim 10). 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 reservoir containing the self-gelling therapeutic formulation, of the system of Erickson et al, to comprise a first functional polymer, a crosslinker, and an anti-inflammatory therapeutic agent configured to provide a sustained release into the cochlea via the cochlear implant lead insertion site of the cochlea, as taught by de Juan et al, as such will generate a crosslinking reaction for a gel when mixed within the reservoir (claim 10) and will allow for mixing and reaction of the formulation components at patient bedside and immediately delivered into the cochlea (paragraph [0173]).
In regards to claim 6, in the modified system of Erickson et al and de Juan et al, Erickson et al is silent about wherein the self-gelling therapeutic formulation comprises the anti-inflammatory therapeutic agent in an amount sufficient to gradually release the anti- inflammatory therapeutic agent into the cochlea over an extended period of multiple weeks. de Juan et al teaches wherein the self-gelling therapeutic formulation comprises the anti-inflammatory therapeutic agent in an amount sufficient to gradually release the anti- inflammatory therapeutic agent into the cochlea over an extended period of multiple weeks (paragraph [0098]). 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 self-gelling therapeutic formulation, of the modified system of Erickson et al and de Juan et al, to comprise the anti-inflammatory therapeutic agent in an amount sufficient to gradually release the anti- inflammatory therapeutic agent into the cochlea over an extended period of multiple weeks, as taught by de Juan et al, as such will advantageously reduce the needed frequency of re-administrations of therapeutic agents (paragraph [0011]).
In regards to claim 7, in the modified system of Erickson et al and de Juan et al, Erickson et al teaches wherein the distal port of the therapeutic gel delivery shaft is sized to output a dosage of the self-gelling therapeutic formulation to both seal the cochlear implant lead insertion site and provide the sustained release of the anti-inflammatory therapeutic agent (Figure 8)(page 11, lines 23-28)(page 3, lines 24-26).
In regards to claim 15, Erickson et al teaches the treatment actuator device (page 11, lines 23-28), wherein the treatment actuator device includes a fluid reservoir containing the self-gelling therapeutic formulation (page 11, lines 23-28)(page 3, lines 24-26), and the distal port of the therapeutic gel delivery shaft is sized to output a dosage of the self-gelling therapeutic formulation to both seal the cochlear implant lead insertion site and provide a sustained release of the dexamethasone into the cochlea (Figure 8)(page 11, lines 23-28)(page 3, lines 24-26); however, Erickson et al is silent about the self-gelling therapeutic formulation comprising a multi-arm polyethylene glycol, a crosslinker, and dexamethasone. de Juan et al teaches a system (Figures 45-46) wherein a treatment actuator device includes a fluid reservoir containing a self-gelling therapeutic formulation comprising a multi-arm polyethylene glycol, a crosslinker, and dexamethasone (paragraphs [0178][0179][0184]). 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 self-gelling therapeutic formulation, of the system of Erickson et al, to comprise a multi-arm polyethylene glycol, a crosslinker, and dexamethasone, as taught by de Juan et al, as such will allow for a crosslinking reaction to occur by mixing of the formulation components at patient bedside and immediately delivered into the cochlea (paragraphs [0173][0177]).
In regards to claim 16, in the modified system of Erickson et al and de Juan et al, Erickson et al teaches a flexible tube (340) extending between the fluid reservoir of the treatment actuator device and the proximal end of the elongate handle of the transmastoid injector tool.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al, as applied to claim 1 above, and further in view of Seo (US 2025/0058051).
In regards to claim 17, Erickson et al teaches wherein a second peak of the elongate handle defines said maximum lateral width of the transmastoid injector tool (Figures 8-9); however, Erickson et al does not teach wherein an exterior of the elongate handle forms an undulating pattern that gradually increases in diameter from a proximal end of the elongate handle to a first peak, gradually decreases in diameter from the first peak to a valley, gradually increases in diameter from the valley to a second peak, and gradually decreases in diameter from the second peak to a distal end of the elongate handle, as Erickson et al instead teaches wherein an exterior of the elongate handle forms a pattern that gradually decreases in diameter from the second peak to a distal end of the elongate handle (Figures 8-9). Seo et al teaches a system (Figures 1A-6B) wherein an exterior of an elongate handle (120) forms an undulating pattern that gradually increases in diameter from a proximal end of the elongate handle to a first peak, gradually decreases in diameter from the first peak to a valley, gradually increases in diameter from the valley to a second peak, and gradually decreases in diameter from the second peak to a distal end of the elongate handle (Figure 1A). 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 an exterior of the elongate handle, of the system of Erickson et al, to form an undulating pattern that gradually increases in diameter from a proximal end of the elongate handle to a first peak, gradually decreases in diameter from the first peak to a valley, gradually increases in diameter from the valley to a second peak, and gradually decreases in diameter from the second peak to a distal end of the elongate handle, as taught by Seo, as such will provide ergonomic features to facilitate gripping by an operator (paragraph [0005]) and may help to provide increased ergonomic comfort to operators, as compared to other shapes (paragraph [0032]).
In regards to claim 18, in the modified system of Erickson et al and Seo, Erickson et al does not teach wherein the exterior of the elongate handle comprises grip edges located at the second peak, the grip edges including ridges that increase a coefficient of friction between fingers of a clinician and the elongate handle as compared with a coefficient of friction between the fingers of the clinician and a smooth surface. Seo teaches wherein the exterior of the elongate handle comprises grip edges (134/136) located at the second peak, the grip edges including ridges (134/136) that increase a coefficient of friction between fingers of a clinician and the elongate handle as compared with a coefficient of friction between the fingers of the clinician and a smooth surface. 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 exterior of the elongate handle, of the modified system of Erickson et al and Seo, to comprise grip edges located at the second peak, the grip edges including ridges, as taught by Seo, as such may serve as finger rests for one or more fingers of an operator's hand, and may serve as positioning aids that assist an operator in positioning his or her hand without seeing handle (paragraph [0028]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al, as applied to claim 1 above.
In regards to claim 19, Erickson et al teaches wherein the visualization shaft has an exterior diameter that is larger than an outer diameter of the therapeutic gel delivery shaft (Figure 8); however, Erickson et al is silent about a combined maximum width of the visualization shaft and the therapeutic gel delivery shaft is less than 2 mm, as Erickson only teaches that a width of the therapeutic gel delivery shaft is about 0.2mm, or between 0.1mm and 0.3mm, or between 0.1mm and 0.5mm, without limitation (page 15, lines 19-21). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify a combined maximum width of the visualization shaft and the therapeutic gel delivery shaft, of the system of Erickson et al, to be less than 2 mm, as Applicant has not disclosed that such a combined maximum width provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with a width of the therapeutic gel delivery shaft being about 0.2mm, or between 0.1mm and 0.3mm, or between 0.1mm and 0.5mm, without limitation, and an unknown width of the visualization shaft, as taught by Erickson et al, as a person having ordinary skill in the art would have known how to size the visualization shaft and the therapeutic gel delivery shaft in order to access the cochlea.
Response to Arguments
Applicant’s arguments with respect to claims 1-13 and 15-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Allowable Subject Matter
Claims 14 and 21-23 are allowed.
In regards to independent claim 14, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a system for delivering a self-gelling therapeutic formulation at a cochlear implant lead insertion site of a cochlea, as claimed, specifically including wherein the transmastoid injector 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 therapeutic gel delivery shaft so that the tip-mounted image capture device is configured to provide simultaneous imaging of both the therapeutic gel delivery shaft and the self-gelling therapeutic formulation deposited at the cochlear implant lead insertion site of the cochlea.
Sacherman et al (US 2022/0126028) teaches a system (Figures 23A-23D) for delivering a self-gelling therapeutic formulation at a cochlear implant lead insertion site of a cochlea, comprising a transmastoid injector tool (930) having a therapeutic gel delivery shaft (921d).
However, Sacherman et al does not teach wherein the transmastoid injector 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 therapeutic gel delivery shaft so that the tip-mounted image capture device is configured to provide simultaneous imaging of both the therapeutic gel delivery shaft and the self-gelling therapeutic formulation deposited at the cochlear implant lead insertion site of the cochlea, as Sacherman et al instead teaches wherein the transmastoid injector tool further comprises an optic line 925a slidable with respect to the visualization shaft (924) and oriented toward the distal port (903) of the therapeutic gel delivery shaft (921d) so that the optic line 925a is configured to provide simultaneous imaging of both the therapeutic gel delivery shaft and the self-gelling therapeutic formulation deposited at the cochlear implant lead insertion site of the cochlea.
Thus, independent claim 14 is allowed. Dependent claims 21-23 are allowed by virtue of being dependent upon independent claim 14.
Claims 8-13 and 20 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 8, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a system for delivering a self-gelling therapeutic formulation at a cochlear implant lead insertion site of a cochlea, as claimed, specifically including wherein the transmastoid injector 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 therapeutic gel delivery shaft so that the tip-mounted image capture device is configured to provide simultaneous imaging of both the therapeutic gel delivery shaft and the self-gelling therapeutic formulation deposited at the cochlear implant lead insertion site of the cochlea.
Erickson et al teaches a system (Figures 8-9) for delivering a self-gelling therapeutic formulation at a cochlear implant lead insertion site of a cochlea, comprising a transmastoid injector tool (Figures 8-9) having both a therapeutic gel delivery shaft (330) and a visualization shaft (420).
However, Erickson et al does not teach wherein the transmastoid injector 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 therapeutic gel delivery shaft so that the tip-mounted image capture device is configured to provide simultaneous imaging of both the therapeutic gel delivery shaft and the self-gelling therapeutic formulation deposited at the cochlear implant lead insertion site of the cochlea, as Erickson et al instead teaches the visualization shaft (420) oriented toward the distal port of the therapeutic gel delivery shaft (330) so that the visualization shaft is configured to provide simultaneous imaging of both the therapeutic gel delivery shaft and the self-gelling therapeutic formulation deposited at the cochlear implant lead insertion site of the cochlea (Figure 8).
Thus, dependent claim 8 is objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim 1. Dependent claims 9-13 are objected to by virtue of being dependent upon independent claim 8.
In regards to dependent claim 20, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a system for delivering a self-gelling therapeutic formulation at a cochlear implant lead insertion site of a cochlea, as claimed, specifically including wherein the transmastoid injector tool further comprises a tip-mounted image capture device fixedly mounted at a distal end of the visualization shaft, the tip-mounted image capture device comprising: an image sensor, and a light source configured to emit light distally from the distal end of the visualization shaft so that the image sensor provides direct visualization of the therapeutic gel delivery shaft.
Erickson et al teaches a system (Figures 8-9) for delivering a self-gelling therapeutic formulation at a cochlear implant lead insertion site of a cochlea, comprising a transmastoid injector tool (Figures 8-9) having both a therapeutic gel delivery shaft (330) and a visualization shaft (420).
However, Erickson et al does not teach wherein the transmastoid injector tool further comprises a tip-mounted image capture device fixedly mounted at a distal end of the visualization shaft, the tip-mounted image capture device comprising: an image sensor, and a light source configured to emit light distally from the distal end of the visualization shaft so that the image sensor provides direct visualization of the therapeutic gel delivery shaft, as Erickson et al instead teaches the visualization shaft (420) to provide direct visualization of the therapeutic gel delivery shaft (330) (Figure 8).
Thus, dependent claim 20 is objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim 1 and intervening claim 19.
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 SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin C Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
Prosecution Insights