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 11/11/2025. As directed by the amendment: claims 1, 8 and 17 have been amended, claims 10-16, 18-20 have been withdrawn, and new claim 21 has been added. Thus, claims 1-9, 17 and 21 are presently pending in the application.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 11/11/2025, with respect to the 103 rejections over Amans in view of Boddu have been fully considered. Applicant argues on page 6, claim 1 was amended to recite conscious sedation, the prior art Boddu discloses general anesthesia and does not disclose conscious sedation is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view Stout U.S. Publication 2021/025105 A1 (filed 12/29/2020).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/11/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 9 is objected to because of the following informalities: claim 9 is dependent on canceled claim 7. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Stout U.S. Publication 2021/025105 A1.
Claim 1, Stout discloses a process for treating at least one of tinnitus and sinus-based stenosis (abstract, paragraphs [0002], [0012-0015] and [0021]), which comprises, in combination, delivery of a system effective for altering venous pressure (paragraphs [0016-0018], [0021] and [0023]) and flow characteristics with conscious sedation (paragraph [0026]).
Claim 2, Stout discloses further comprising venous stenting with endovascular pressure feedback (see Figure 2 and paragraph [0006], [0023], [0026]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3-6, 8-9, 17 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stout U.S. Publication 2021/025105 A1 in view of Amans WO 2018/112118 A1.
Claims 3, 21 Stout discloses treating tinnitus (see paragraphs [0009], [0012-0014], [0016-0017]). However, Stout does not expressly disclose treating pulsatile tinnitus. Amans teaches a process for treating at least one of tinnitus and sinus-based stenosis (paragraph [0005-0009]), which comprises, in combination, delivery of a system effective for altering venous pressure and flow characteristics (abstract and paragraphs [0005-0009], [0011], [0013]), including treating pulsatile tinnitus (paragraphs [0003], [0005], [0011], [0013], [0038-0039]) for the purpose of correcting irregular flow pattern having a strong vortex and thus removing the sound generated associated with the blood flow and treating pulsatile tinnitus (paragraph [0005]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Stout’s process of treating tinnitus to further include treating pulsatile tinnitus as taught by Amans for the purpose of correcting irregular flow pattern having a strong vortex and thus removing the sound generated associated with the blood flow and treating pulsatile tinnitus.
Claim 4, Stout discloses the etiology being vascular and classified based upon location as venous, arterial, or A-V (abstract, paragraphs [0013-0014] and [0016]).
Claim 5, Stout discloses said venous stent/flow diverter providing for symptomatic control and resolution of tinnitus (paragraphs [0012], [0015-0018]).
Claim 6, Stout discloses checking pressure post stent/flow diverter deployment to ensure resolution and repeat to achieve desired outcome or resolution to tinnitus (see paragraphs [0012], [0014], [0016], [0023] and [0026]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Stout’s process to have an outcome that post stent/flow diverter deployment no pressure gradient exists further in addressed sinus, vein, or artery to ensure resolution of tinnitus.
Claims 8, 9, Stout does not disclose a stent/flow diverter with more than four crowns or having at least about 5-8 crowns. Amans teaches a process for treating at least one of tinnitus and sinus-based stenosis (paragraph [0005-0009]), which comprises, in combination, delivery of a system effective for altering venous pressure and flow characteristics (abstract and paragraphs [0005-0009], [0011], [0013]), the system comprises a venous tent/flow diverter 10 (paragraphs [0017], [0039], [0050-0051]), wherein stent comprises an end with at least 5 to 8 crowns for the purpose of having a plurality of attachment members to embed the device in the venous wall (as seen in Figure 3 and paragraph [0040]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Stout’s process of treating tinnitus with a stent to further include an end with at least 5 to 8 crowns as taught by Amans for the purpose of having a plurality of attachment members to embed the device in the venous wall.
Claim 17, Stout discloses whereby the conscious sedation enables a patient to perceive the resolution of the tinnitus (paragraphs [0012], [0014], [0016], [0023] and [0026]).
Claim(s) 1-6, 8-9, 17 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amans WO2018/112118 A1 in view of Stout U.S. Publication 2021/0205105 A1.
Regarding Claim 1, Amans discloses a process for treating at least one of tinnitus and sinus-based stenosis (paragraph [0005-0009]), which comprises, in combination, delivery of a system effective for altering venous pressure and flow characteristics (abstract and paragraphs [0005-0009], [0011], [0013]). However, Amans does not expressly disclose delivery of a system with conscious sedation. Stout teaches a process for treating at least one of tinnitus and sinus-based stenosis (abstract, paragraphs [0002], [0012-0015] and [0021]) in the same field of endeavor comprising a delivery of a system effective for altering venous pressure (see Figures 1-3 and paragraphs [0016-0018], [0021] and [0023]) and flow characteristics with conscious sedation (paragraphs [0009], [0012], [0026]) for the purpose of having the patient being awake to allow the patient to verify resolution (see claims 2, 6, 10 of Stout and paragraph [0026]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Amans process of treating sinus-based stenosis to further include having the patient awake (conscious sedation) as taught by Stout for the purpose of having the patient being awake to allow the patient to verify resolution.
Claim 2, Amans does not expressly disclose venous stenting with endovascular pressure feedback. Stout teaches a process for treating at least one of tinnitus and sinus-based stenosis (abstract, paragraphs [0002], [0012-0015] and [0021]) in the same field of endeavor comprising a stent/flow diverter 3011 into a venous lesion and taking venous pressure via catherization and re-checking pressure post deployment of stent (as seen in Figures 2-3 and abstract and paragraphs [0002-0004] and [0016]) for the purpose of verifying resolution of tinnitus (paragraphs [0014], [0016]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Amans process of treating sinus based stenosis to further include taking venous pressure and recheck venous pressure post deployment of stent as taught by Stout for the purpose of verifying resolution of tinnitus.
Regarding Claim 3, Amans treating at least one of pulsatile or non-pulsatile tinnitus (paragraphs [0003], [0013], [0038-0039]).
Regarding Claim 4, Amans the etiology being vascular and classified based upon location as venous, arterial, or A-V (paragraphs [0039-0040]).
Regarding Claim 5, Amans said venous stent/flow diverter providing for symptomatic control and resolution of tinnitus (paragraph [0067]).
Regarding Claim 6, Amans discloses the stent is used to treat tinnitus (pulsatile or non-pulsatile) and corrected abnormal venous flow (paragraphs [0011], [0013], [0040-0041]), therefore, by implanting Amans device would ensure no pressure gradient exists further in addressed sinus, vein, or artery.
Regarding Claim 8, Amans, driven by a stent/flow diverter with more than four crowns (as seen in Figure 3).
Regarding Claim 9, Amans, said stent/flow diverter having at least about 5-8 crowns (as seen in Figure 3).
Claim 17, Amans does not expressly disclose whereby the conscious sedation enables a patient to perceive the resolution of the tinnitus. Stout teaches a process for treating at least one of tinnitus and sinus-based stenosis (abstract, paragraphs [0002], [0012-0015] and [0021]) in the same field of endeavor comprising a delivery of a system effective for altering venous pressure (see Figures 1-3 and paragraphs [0016-0018], [0021] and [0023]) and flow characteristics with conscious sedation (paragraphs [0009], [0012], [0026]) for the purpose of having the patient being awake to allow the patient to verify resolution (see claims 2, 6, 10 of Stout and paragraph [0026]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Amans process of treating sinus-based stenosis to further include having the patient awake (conscious sedation) as taught by Stout for the purpose of having the patient being awake to allow the patient to verify resolution.
Regarding Claim 21, Amans discloses treating pulsatile tinnitus (paragraphs [0003], [0013], [0038-0039]).
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 SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774