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
The amendment filed 12/17/25 has been entered. Claims 1-3 have been amended. Claims 4-5 are in the original form. Thus, claims 1-5 remain pending in the application. Applicant’s amendments to the Drawings and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 09/19/25.
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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (U.S. PGPUB No. 2020/0205845), hereinafter Yang in view of Garrison et al. (U.S. PGPUB No. 2015/0174368), hereinafter Garrison.
Regarding claim 1, Yang discloses an aspiration catheter (See FIG. 31A and [0021]: catheter for aspirating embolic material from a vessel), comprising:
an elongate flexible tubular body (3000) having a proximal end (see [0243]), a side wall (see [0248]: side wall of catheter) and a distal tip (3006, see [0244]: beveled distal surface 3006), wherein a helical coil (3024, see [0243] & [0245]: coil 3024) is embedded in the side wall (see FIG. 31A and [0248]) and extends from the proximal end (see [0243]: coil 3024 can extend to proximal end) to a location offset proximally (see [0244]: distal end of coil 3024 can be spaced==offset proximally from the distal end) from the distal tip (3006), a reinforcement fiber (3042, see [0248]: axially extending filament 3042) is longitudinally (axially==longitudinally) embedded in the side wall (see [0248]: filament 3042 in catheter wall as seen in FIG. 31A) starting from a location offset proximally (see [0248-0249]: 3042 extends from a distance of 1cm from distal end) from the distal tip (3006) and extending proximally at least 10cm (see [0250-0251]: filament length greater than 10cm== “at least” 10cm); and
wherein the distal tip (3006, see [0263]: any of the catheters of the invention may include a sinusoidal tip as shown in FIG. 41A-B. Therefore, FIG. 41A-B is referenced for the following distal tip structures that are considered disclosed in the embodiment of FIG.31A according to [0263]. See ‘FIG.31A with Sinusoidal tip of FIG. 41A-B’ below)
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has a wave-shaped edge (see [0274]: a sinusoidal/ wave shape) which smoothly transitions (see [0274]: radius of curvature may be ‘similar’ which would result in a smooth transition as shown in FIG. 41B) between peaks (4120, see [0274]: concave wave shape 4120) and valleys (4110, see [0274]: convex wave shape 4110) circumferentially to define tapers (see [0274]: wave shapes have radius of curvature==circumferentially defined taper, see FIG. 41B for full view of circumferential edge).
Yang is silent to “a plurality of” peaks and “a plurality of” valleys, “wherein each of the plurality of peaks extends in a greater distal direction than any of the plurality of valleys.”
However, Garrison teaches an aspiration catheter (see [0032]) comprising an elongated flexible tubular body (105, see FIG. 5) have a distal tip (210), wherein the distal tip (210) has a wave-shaped edge which smoothly transitions between a plurality of peaks and a plurality of valleys circumferentially to define tapers (see ‘Modified FIG. 5’ below and [0032]: distal tip 210 has an edge with a non-perpendicular angle relative to the longitudinal axis),
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wherein each of the plurality of peaks extends in a greater distal direction (see ‘Modified FIG. 5’ above) than any of the plurality of valleys (as seen in ‘Modified FIG. 5’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip comprising a wave-shaped edge formed of a peak and valley defining a taper disclosed by Yang to include a plurality of peaks and valleys, wherein the peaks extend a greater distal distance than the valleys as taught by Garrison for the purpose of optimizing the contact area to provide a larger suction force at the catheter distal tip to facilitate the aspirated material into the catheter lumen (see [0032]), thus achieving “a plurality of” peaks and “a plurality of” valleys, “wherein each of the plurality of peaks extends in a greater distal direction than any of the plurality of valleys.”
Regarding claim 2, the modified system of Yang teaches the catheter of claim 1, but Yang is silent to “wherein there are two to five peaks and two to five valleys.”
However, However, Garrison teaches an aspiration catheter (see [0032]) comprising an elongated flexible tubular body (105, see FIG. 5) have a distal tip (210), the distal tip (210) having peaks and valleys (see ‘Modified FIG. 5’ above), wherein there are two to five peaks and two to five valleys (see two peaks and two valleys as labeled in ‘Modified FIG. 5’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip comprising a wave-shaped edge formed of a peak and valley defining a taper disclosed by Yang to include two peaks and two valleys as taught by Garrison for the purpose of optimizing the contact area to provide a larger suction force at the catheter distal tip to facilitate the aspirated material into the catheter lumen (see [0032]), thus achieving “wherein there are two to five peaks and two to five valleys.”
Regarding claim 3, the modified system of Yang teaches the catheter of claim 2, and Yang further discloses wherein a distance between each peak and each valley ranges from 0.1mm to 3mm (see [0274] diameter of each peak 4120 and each valley 4110 can be 0.02inches==0.508 mm. Therefore a “distance” measured across the diameter of the peak or valley between each peak and each valley is 0.508mm, within the claimed range.).
Regarding claim 4, the modified system of Yang teaches the catheter of claim 1, and Yang further discloses wherein the helical coil (3024, see FIG. 31A) has a distal end (see [0244]: a distal end of coil 3024 spaced proximally from distal end), and further including a radiopaque marker band (3040) that is proximal of the distal tip (3006) and at (see [0244]: radiopaque marker 3040 provided after coil 3024 as seen in FIG. 31A, aligning with Applicant disclosure in [0027]: radiopaque marker between distal end of coil and distal tip of catheter tubular body) the distal end of the helical coil (3024).
Regarding claim 5, the modified system of Yang teaches the catheter of claim 4, and Yang further discloses wherein one end of the reinforcement fiber (3042, see FIG. 31A) is attached at (see [0245]: sleeve 3020 provided over all elements of catheter body including fiber 3042 and marker band 3040, aligning with Applicant disclosure in [0029]: marker placed over fiber) the radiopaque marker band (3040).
Response to Arguments
Applicant’s arguments with respect to claims 1-5 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.
A new 35 U.S.C. § 103 rejection under Yang in view of Garrison has been used to meet the newly amended claim limitations, rendering the arguments against the 35 U.S.C. § 102 claim rejections under Yang moot.
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 KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783