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 Arguments
Applicant's arguments filed 1/14/2026 have been fully considered but they are not persuasive. In response to applicant's arguments against the references individually (i.e., Walzman does not disclose a steering part made of a magnet as claimed, while Stangenes does not disclose an expanding part structure including a tip magnet), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As noted in more detail in the rejection below, Walzman disclose an expanding part including a tip magnet as claimed and Stangenes is relied upon for its teaching of a steering part comprising a circular base magnet. Walzman has been modified in view of Stangenes to replace its pull wire steering part with a steering part having a circular base magnet as claimed.
Applicant also asserts that, even assuming the substitution of steering mechanisms were accepted, the cited combination neither teaches nor suggests the claimed decoupled control scheme (page 7 of remarks). This is not found persuasive as Walzman discloses that the tip, which is biased open, is collapsed via attraction of the arc-shaped magnets ([0443], [0444]). Thus, the diameter of the catheter end is controlled by a strength of the magnetic field (noting that, when the strength of the magnetic field is zero, the tip remains expanded, and when the strength of the magnetic field is sufficient to overcome any intrinsic resistance of the filter element to collapse, the diameter is reduced as per [0444]). Stangenes expressly discloses that the steering of the circular base magnet (48; figs. 7-9) is controlled by adjusting a direction of the magnetic field applied by the magnetic field generator (22; [0034]; note also figs. 1, 11a,11b). Thus, adjusting the strength of the magnetic field controls a diameter of the end of the catheter and adjusting the direction of the magnetic field controls steering of the catheter end of the device of Walzman as modified by Stangenes.
Claim Objections
Claim 7 is objected to because of the following informalities: in lines 6-7 “provided an end” should read “provided at an end”. Appropriate correction is required.
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.
Claim 11 is 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 11 recites “the catheter end” in line 11. Since two catheters are recited in the claim (aspiration catheter in line 1 and pressure-measurement catheter in line 8) it is unclear which previously recited catheter is being referenced. Since the aspiration catheter is claimed as expandable (noting preamble of claim), it is best understood that the catheter end is meant to refer to the end of the aspiration catheter. For purposes of claim interpretation, “the catheter end” is being treated as though it reads “an end of the aspiration catheter”.
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walzman (US 2021/0236257) in view of Stangenes et al. (US 2014/0316407).
Walzman discloses a steerable and expandable aspiration catheter (1000; fig. 10A) comprising a body (proximal half of solid walled tubular portion of 1000), a steering part provided at the distal end of the body (distal half of solid walled tubular portion of 1000, connected to and controlled by a pull wire; see [0181], [0558]), an expanding part (1004) provided at an end of the steering part (see magnets 1080i-1080iii; fig. 10A) and positioned at an end of the steering part, wherein the expanding part includes a tip magnet part (magnets 1080i-1080iii) and a leg (mesh, or any one of mesh filaments of expandable filter 1004) connecting the tip magnet part and the steering part to each other. The tip magnet part is a combination of a plurality of arc-shaped magnets ([0444] – as understood by “non-linear (e.g., curved)” bar) with polarities disposed in a circumferential direction ([0445)], and is displaced outward in a radial direction based on a strength of the magnetic field generated around the expanding part to expand a diameter of the end of the catheter, and a magnetic field generator (1092 and 1090) generating a magnetic field around the expanding part, wherein the magnetic field generator controls a diameter of an end of the catheter by adjusting a strength of the magnetic field ([0441]-[0444]).
Walzman fails to disclose that the steering part is made of a magnet, wherein the steering part controls steering of the steering part based on a direction of the magnetic field.
Stangenes discloses another steerable catheter having a lumen therethrough. Stangenes discloses a steering part (flexible distal segment 20; [0029]) provided at an end of a body (12, proximal of 20) of the catheter, wherein the steering part is a circular base magnet 42; figs. 7-9a) and polarities are disposed along a length direction of the catheter ([0064]). A magnetic field generator (22) controls steering of the steering part by adjusting a direction of the magnetic field applied by the magnetic field generator generating unit (22; [0034]; note also figs. 1, 11a,11b). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Walzman to include a steering part comprising a circular base magnet as claimed in view of Stangenes, in place of the pull wire steering mechanism, since such a modification can be considered a substitution of one known steering mechanism (steering part comprising flexible segment and pull wire) for another (steering part comprising a flexible segment and circular base magnet controlled by direction of magnetic field), wherein the results of such a modification are predictable and one skilled in the art would have been a reasonable expectation of success.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walzman in view of Stangenes and Atkinson et al. (US 2014/0025143). Walzman discloses a steerable and expandable aspiration catheter (1000; fig. 10A) comprising a body (proximal half of solid walled tubular portion of 1000), a steering part positioned at the distal end of the body (distal half of solid walled tubular portion of 1000, connected to and controlled by a pull wire; see [0181], [0558]), an expanding part (1004) made of a combination of a plurality of magnets (1080i-1080iii; fig. 10A) and positioned at an end of the steering part, and a magnetic field generator (1092 and 1090) generating a magnetic field around the expanding part, wherein the expanding part controls a diameter of an end of the aspiration catheter (note 35 USC 112b rejection above)based on a strength of the magnetic field ([0441]-[0444]).
Walzman fails to disclose that the steering part is made of a magnet, wherein the steering part controls steering of the steering part based on a direction of the magnetic field.
Stangenes discloses another steerable catheter having a lumen therethrough. Stangenes discloses a steering part (flexible distal segment 20; [0029]) made of a magnet (42; fig. 7) and positioned at an end of a body (12, proximal of 20) of the catheter. The steering part controls steering of the steering part based on a direction of the magnetic field applied by a magnetic field generator (22; [0034]; note also figs. 1, 11a,11b). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Walzman to include a steering part comprising a circular base magnet as claimed in view of Stangenes, in place of the pull wire steering mechanism, since such a modification can be considered a substitution of one known steering mechanism (steering part comprising flexible segment and pull wire) for another (steering part comprising a flexible segment and circular base magnet controlled by direction of magnetic field), wherein the results of such a modification are predictable and one skilled in the art would have been a reasonable expectation of success.
Walzman in view of Stangenes fails to disclose a pressure-measurement catheter provided on an outside of the body and configured to measure surrounding pressure.
Atkinson et al. discloses an aspiration catheter (300; [0069]; fig. 20) in combination with a guide catheter (80) that includes a pressure sensor for measuring surrounding pressure ([0044]; fig. 20). The guide catheter is provided on an outside of the body of the aspiration catheter (fig. 20). It would have been obvious to one of ordinary skill in the art to have modified the prior art Walzman to include a pressure-measurement catheter on an outside of the body of the aspiration catheter in the form of guide catheter that includes a pressure sensor as taught by Atkinson since some physicians prefer to make periodic intravascular pressure measurements via a guide catheter as taught by Atkinson ([0044]).
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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KSH 3/24/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771