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 .
Appeal Brief
In view of the appeal brief filed on 09/22/2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783
Response to Arguments
Applicant's arguments filed on 09/22/2025 have been fully considered.
In response to applicant's argument (page 2) that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to the arguments (page 3, lines 7-9) that “Spiggle’ s multi-lumen, dual-balloon arrangement is fundamentally distinct from Appellant’s invention, which recites a single balloon catheter with an injection channel terminating distal to the balloon in a self-closing outlet”, examiner respectfully disagrees. Even if Spiggle discloses a catheter with a multi-lumen and dual-balloon arrangement, the prior art discloses a catheter tube (catheter 1), an expandable balloon (balloon 5) for an occlusion of the eustachian tube (para 0007), an injection channel (lumen 9) for introducing medication into a middle ear region (para 0007). The applicant is reminded that the claims required a catheter, a balloon and a lumen but the limitations does not preclude the catheter from also having a multi-lumen and dual-balloon arrangement.
In response to applicant's argument (page 3, lines 16-18) that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a single balloon that occludes the eustachian tube and works cooperatively with a distal self-closing outlet to achieve medication retention in the middle ear) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument (page 4, lines 6-8) that “Parker does not correct the deficiencies of Spiggle in failing to disclose “a single-balloon device with an injection channel terminating distal to the balloon in an inherently self-closing outlet or any removable slotted handling aid”, examiner respectfully disagrees. Parker discloses a catheter with a handling aid so someone of ordinary skill in the art before the effective filing date of the claimed invention would be motivated to modify the disclosure of Spiggle 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).
In response to applicant's argument (page 3, lines 16-18) that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., It is a removable sleeve-type structure integrated with the ear catheter, allowing fitting or removal in the confined ear/nasal anatomy without the bulk or locking mechanisms of Parker’s vascular grip) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to the arguments (page 4, lines 16-18) that “incorporating Parker’s hinged grip into Spiggle’ s multi-lumen ear catheter would add unnecessary size and complexity, contrary to the requirements for a slim, atraumatic otologic device”, examiner respectfully disagrees as there is no support that the modification would add unnecessary size and complexity.
Applicant’s arguments on “Spiggle’ s disclosure of “valves, slides, flaps, or taps” as allegedly teaching a “self-closing outlet” have been considered and are persuasive.
Applicant’s arguments for claim 4 have been considered and are persuasive.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation “characterized by a pressure limiter for a maximum pressure of 1 bar”, it is unclear what is meant by “characterized by a pressure limiter for a maximum pressure of 1 bar” and whether the pressure limiter is being positively recited. Examiner suggests that the applicant to amend the claim language that includes “comprising”.
Claim 9 recites the limitation "an outlet opening" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purpose of examination, “an outlet opening” in claim 9 will be interpreted as “the outlet opening” already recited in claim 1.
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, 8-9 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Spiggle (US 20190209815 A) in view of Chen et al (US 20180296810 A1) and further in view of Parker (US 20170238829 A1).
Regarding claim 1, Spiggle discloses a non-invasive ear catheter for introduction into an eustachian tube (fig 1, catheter 1 and para 0007), comprising: a catheter tube (shaft 2), an expandable balloon (first inflatable balloon 5) for an occlusion of the eustachian tube (para 0007), an injection channel (application lumen 9) for introducing medication into a middle ear region (para 0007), wherein the injection channel (lumen 9) has an outlet opening (outlet opening 12, para 0054) at its distal end that ends distal to the balloon.
Even though Spiggle discloses the outlet opening (12) may have a device, such as a valve, a slide, a flap or a tap (para 0018), Spiggle fails to disclose explicitly that the valve is of self-closing design.
However, Chen et al disclose a catheter (see figs 2 and 3, 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 Spiggle 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).
Spiggle also fails to teach the non-invasive ear catheter comprises a handling aid, wherein the handling aid is slotted so that it can be fitted or removed.
However, Parker discloses a catheter shaft (fig 3, catheter 290) comprising a handling aid (catheter grip 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 Spiggle 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 2, Spiggle in view of Chen et al and Parker discloses the non-invasive ear catheter according to claim 1, characterized in that the injection channel (lumen 9) extends inside the catheter (see figs 1 and 2).
Regarding claim 3, Spiggle in view of Chen et al and Parker discloses the non-invasive ear catheter according to claim 1, characterized in that the expandable balloon (balloon 5) is designed as a low-pressure cuff (para 0028).
Regarding claim 8, Spiggle in view of Chen et al and Parker discloses the non-invasive ear catheter according to claim 1, characterized in that the injection channel (lumen 9) ends distally from the balloon (see fig 2).
Regarding claim 9, Spiggle in view of Chen et al and Parker discloses the non-invasive ear catheter according to claim 1, characterized in that the injection channel (lumen 9) is provided with an outlet opening (opening 12) that is of atraumatic design (para 0024).
Regarding claim 12, Spiggle in view of Chen et al and Parker discloses the non-invasive ear catheter according to claim 1, characterized in that the handling aid (grip 102) is a plastic sleeve frictionally mounted on the catheter tube (para 0016 of Parker).
Regarding claim 13, Spiggle in view of Chen et al and Parker discloses the non-invasive ear catheter according to claim 1 to be employed for the non-invasive application of medication into the middle ear of a patient (abstract and para 0006).
Regarding claim 14, Spiggle in view of Chen et al and Parker disclose the non-invasive ear catheter according to claim 13, characterized in that the non-invasive ear catheter is suitable for retaining the medication in the middle ear (para 0007 and 0008).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Spiggle (US 20190209815 A) in view of Chen et al (US 20180296810 A1) and in view of Parker (US 20170238829 A1) and further in view Eliasson et al (US 20180177937 A1).
Regarding claim 4, Spiggle in view of Chen et al and Parker discloses the limitations of claim 1 but fail to teach the non-invasive ear catheter according to claim 1, characterized by a pressure limiter for a maximum pressure of 1 bar.
Spiggle discloses the balloons are inflatable with less than 1 bar (para 0028).
However, Eliasson et al disclose a catheter (catheter 2, see fig 1) comprising a balloon (balloon 21) characterized by a pressure limiter (safety element 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 Spiggle in view of Chen et al and Parker 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 1 bar (see para 0123).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Spiggle (US 20190209815 A) in view of Chen et al (US 20180296810 A1) and in view of Parker (US 20170238829 A1) and further in view of Becker (US 20150230809 A1).
Regarding claim 5, Spiggle in view of Chen et al and Parker discloses the limitations of claim 1 but fails to teach the non-invasive ear catheter, characterized in that the injection channel is provided with a Luer lock connection for a syringe containing injection material.
However, Becker discloses a catheter (see fig 1 and abstract) wherein an injection channel (fig 1, lumen 33) is provided with a Luer lock connection (connection 52) for a syringe (syringe 110, fig 7) 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 modify the catheter of Spiggle in view of Chen et al and Parker and incorporate the teachings of Becker to have said injection channel provided with a Luer lock connection for a syringe containing injection material. This modification would provide the benefit of securely connecting said injection channel to a syringe to inject material through said injection channel (see para 0105).
Regarding claim 6, Spiggle discloses in view of Chen et al and Parker discloses the limitations of claim 1 but fail to teach the non-invasive ear catheter, characterized in that the catheter tube is provided with a Luer lock connection for a liquid medium for the expansion of the balloon.
However, Becker teaches a catheter tube (sheath 40; Figure 1) characterized in that the catheter tube is provided with a Luer lock connection (see fig 1, luer lock 54) for a liquid medium for the expansion of the balloon (para 0085 and 0110).
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 Spiggle in view of Chen et al and Parker and incorporate the teachings of Becker by including a luer lock connection for a liquid medium for the expansion of the balloon. This would the benefit of securing said catheter tube when inflating said balloon (para 0110).
Regarding claim 7, Spiggle in view of Chen et al and Parker and Becker discloses the non-invasive ear catheter according to claim 6, characterized in that the liquid medium for expanding the balloon is a physiological NaCl solution (para 0012).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783