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
This office action is responsive to the amendment filed on 11/20/2025. As directed by the amendment: claims 1-9 & 12-13 have been amended. Claims 10 and 11 have been cancelled. Clams 15 and 16 have been added.
Thus, claims 1-9 & 12-16 are pending in this application.
Applicant’s amendments to the claims have overcome each and every 112(b) claim rejection previously set forth in the Non-final Office Action mailed on 11/20/2025.
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.
Claims 1-3, 6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Makower et al (US 20080275483 A1).
Regarding claim 1, Makower et al disclose a non-invasive ear catheter ((600), para 0011), comprising: a catheter tube (602), a single expandable balloon (606), and an injection channel (603) for introducing a medication (para 0249), wherein the injection channel (603) has an outlet opening (opening of 603) at its distal end that ends distal to the single expandable balloon (fig 6A).
Makower et al fail to expressly disclose said ear catheter is for introduction into an eustachian tube and said balloon is used for an occlusion of the eustachian tube and said injection channel is for introduction of medication into a middle ear region.
However, Makower et al teach said catheter may be used to treat disorders in other anatomical structure within the ear (para 008-0020).
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 device of Makeover et al to have the device be used to treat disorders in other anatomical structure within the ear by having said ear catheter for introduction into an eustachian tube and said balloon is used for an occlusion of the eustachian tube and said injection channel is for introduction of medication into a middle ear region.
Examiner notes: The limitations “for introduction into an eustachian tube, for an occlusion of the eustachian tube and for introduction of medication into a middle ear region” are functional limitations and do not add any further structure to the claim so that the prior art doesn’t need to explicitly teach the device performing the claimed function. Thus, the catheter of Makower is fully capable of occluding the eustachian tube and said injection channel can be used for introduction of medication into a middle ear region if it is intended to be used in ear.
Regarding claim 2, Makower et al disclose the non-invasive ear catheter according to claim 1, wherein the injection channel (602) extends inside the catheter (fig 6A).
Regarding claim 3, Makower et al disclose the non-invasive ear catheter according to claim 1, wherein the single expandable balloon (606) is designed as a low-pressure cuff (para 0195, lines 1-5).
Regarding claim 6, Makower et al disclose the non-invasive ear catheter according to claim 1, wherein the catheter tube (602) is provided with a Luer lock connection (610) for a liquid medium for the expansion of the single expandable balloon (para 0145, lines 18-22).
Regarding claim 8, Makower et al disclose the non-invasive ear catheter according to claim 1, wherein the injection channel (603) ends distally from the single expandable balloon (fig 6A).
Regarding claim 9, Makower et al disclose the non-invasive ear catheter according to claim 1, wherein the outlet opening (opening of 603) that is of atraumatic design (para 0145, lines 9-12).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Makower et al (US 20080275483 A1) in view of Eliasson et al (US 20180177937 A1).
Regarding claim 4, Makower et al disclose the limitations of claim 1 but fail to teach said non-invasive ear catheter further comprising a pressure limiter for a maximum pressure of 1 bar.
Makower et al disclose a pump constructed to inflate the balloon to a predetermined pressure (claim 6).
However, Eliasson et al disclose a catheter ((2), see fig 1) comprising a balloon (21) characterized by a pressure limiter ((84), see figure 2) for a maximum pressure (par 0123).
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 catheter of Makower et al and incorporate the teachings of Eliasson et al to have a pressure limiter for a maximum pressure. This would provide the benefit of keeping the balloon as a low pressure balloon and having a pressure limiter that is automatically activated to turn off the pump if the pressure reaches or exceeds a predetermined pressure of 1 bar (see para 0123).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Makower et al (US 20080275483 A1) in view of Becker (US 20150230809 A1).
Regarding claim 5, Makower et al disclose the limitations of claim 1 and further disclose wherein the injection channel (603) is provided with a Luer lock connection (612) but fail to teach said Luer lock connection is for a syringe containing injection material.
However, Becker discloses a catheter (40) wherein an injection channel (33) is provided with a Luer lock connection (52) for a syringe (110) containing injection material (para 0105).
Therefore, it would have been obvious to one of ordinary skill in the art before the .effective filing date of the invention to have the Luer lock connection of Makower et al to be connected with a syringe containing injection material as taught by Becker. This modification would provide the benefit of securely and easily connecting said injection channel to a syringe to inject material through said injection channel (see para 0105).
Claims 7 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Makower et al (US 20080275483 A1) in view of Spiggle (US 20190209815 A).
Regarding claim 7, Makower et al disclose the limitations of claims 1 and 6 but fail to teach wherein the liquid medium for expanding the single expandable balloon is a physiological NaCl solution.
However, Spiggle discloses a non-invasive ear catheter for introduction into an eustachian tube ((1) and para 0007), comprising: a catheter tube (2), an expandable balloon (5) for an occlusion of the eustachian tube (para 0007), wherein a liquid medium for expanding the single expandable balloon is a physiological NaCl solution (para 0012).
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 catheter of Makower et al and incorporate the teachings of Spiggle to have a liquid medium for expanding the single expandable balloon to be a physiological NaCl solution. This would provide the benefit of inflating balloon by introducing fluids, more preferably saline solution which are widely used for balloon inflation in temporary procedure (para 0012).
Regarding claim 13, Makower et al disclose the limitations of claim 1 but silent wherein the non-invasive ear catheter is suitable for the non-invasive application of medication into the middle ear of a patient.
However, Spiggle discloses a non-invasive ear catheter for introduction into an eustachian tube ((1) and para 0007), comprising: a catheter tube (2) wherein the non-invasive ear catheter is suitable for the non-invasive application of medication into the middle ear of a patient (para 0006).
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 catheter of Makower et al and incorporate the teachings of Spiggle to have the non-invasive ear catheter suitable for the non-invasive application of medication into the middle ear of a patient. This would provide the benefit of applying medication into the middle ear of a patient when said catheter is used to treat a disorder in the middle ear (see para 0006).
Regarding claim 14, Makower et al disclose the limitations of claim 1 but silent wherein the non-invasive ear catheter is suitable for retaining the medication in the middle ear.
However, Spiggle discloses a non-invasive ear catheter for introduction into an eustachian tube ((1) and para 0007), comprising: a catheter tube (2) for retaining the medication in the middle ear (para 0007-8).
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 catheter of Makower et al and incorporate the teachings of Spiggle to have the non-invasive ear catheter is suitable for retaining the medication in the middle ear. This would provide the benefit of having said medication remain into the middle ear of a patient when said catheter is used to treat a disorder in the middle ear (see para 0007-8).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Makower et al (US 20080275483 A1) in view of Chen et al (US 20180296810 A1).
Regarding claim 15, Makower et al disclose the limitations of claim 1 but fail to teach wherein the outlet opening is of self-closing design.
However, Chen et al disclose a catheter (26) comprises a channel (lumen of tube 26) having an outlet opening (distal end of the tube 26) with a self-closing design (valve 32, see figs 3A-B, para 0031, 0037 and 0038).
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 catheter of Makower et al and incorporate the teachings of Chen et al to have said outlet opening designed as self-closing. This would provide the benefit of having an outlet opening which automatically opens to allow fluid to flow out of the tube and automatically closes to preclude back flow into the tube. Having this design is useful to retain medication in the middle ear (para 0031).
Claims 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Makower et al (US 20080275483 A1) in view of Parker (US 20170238829 A1).
Regarding claim 16, Makower et al disclose the limitations of claim 1 but fail to teach said non-invasive ear catheter further comprising a handling aid which is slotted so that it can be fitted or removed.
However, Parker discloses a catheter shaft (290) comprising a handling aid (102), wherein the handling aid is slotted (bore 104) so that it can be fitted or removed (para 0022 and 0023).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Makower et al and incorporate the teachings of Parker to provide a handling aid with a slot so that it can be fitted or removed. This would provide the benefit for better manipulation, easier control, and puts less strain on the doctor (see para 0023).
Regarding claim 12, Makower et al disclose the non-invasive ear catheter according to claim 16,
Parker further discloses wherein the handling aid (102) is a plastic sleeve frictionally mounted on the catheter tube (para 0016).
Response to Arguments
Applicant’s arguments with respect to claim(s) to 1-9, 12-13 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.
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.
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/FATIMATA SAHRA DIOP/ Examiner, Art Unit 3783
/BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783
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