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
The amendments to the claims have overcome the previously presented 35 USC 102a1 rejections over Nishihara and the 35 USC 102a1 rejections over Demarais. Amended claims 6, 9, 12, 14, and 16 no longer invoke 35 USC 112f in view of the amendments replacing “rotation transmission mechanism” with “motor”.
Applicant's arguments filed 4/2/2026 with respect to the combination of Demarais in view of Shinozuka have been fully considered but they are not persuasive. Applicant asserts that the proposed modification would render the prior art invention unsatisfactory for its intended purpose. However, applicant does not provide any specific reasons why modifying the wire rod (34) of Demarais to be twisted along its length in view of Shinozuka would prevent the device of Demarais from being used for its intended purposes of transporting material fragmented by the working end of the device through a tube of the device. Instead, Applicant argues it would not have been obvious to isolate the twisted strand 11D of Shinozuka from the wire rope “W” of Shinozuka because the isolated twisted strand would no longer maintain its twist. First, it is noted that applicant provides no evidence that the twist of strand 11D about its own longitudinal axis (fig. 5a, 5c of Shinozuka) is maintained by the other strands. Second, no modification is being made to the prior art of Shinozuka. Rather, the prior art of Demarais is being modified in view of Shinozuka to provide a twist in wire (34) of Demarais in order to provide a particularly effective drain ditch for viscous material, thus enhancing gripping of the tissue by the wire rod (see [0044] of Shinozuka) thereby further facilitating transport of the fragmented tissue through the tube via rotation of the shaft (32) and wire rod (34) of Demarais.
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 2-3 and 8-13 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. Claims 2 and 3 each recite “the base wire rod” (emphasis added) in line 5, which lacks clear antecedent basis, noting only a “wire rod” has been previously recited. As best understood, “the base wire rod” should read “the
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) 1, 3-7 and 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demarais et al. (US 2004/0219028) in view of Shinozuka (US 2003/0139750). Regarding claims 1 and 3, Demarais discloses a lesion retrieval device comprising a shaft (32/122; fig. 3b) having an elongated outer shape, a spirally-arranged protruding portion (34/148) spirally protruding from an outer peripheral surface of the shaft, and an outer cylindrical tube (12/146) having a hollow cylindrical shape and accommodating, inside thereof, part of a proximal end side of the shaft provided with the spirally-arranged protruding portion, wherein the spirally arranged protruding portion comprises a wire rod ([0060]) that is spirally wound around the outer peripheral surface of the shaft (fig. 3b, 5, 5a, 5b), and a surface of the wire rod in a transverse cross-section has irregularities. In particular, Demarais discloses that a transverse cross-section of the wire rod may be “irregular” ([0060]) and thus it is understood that the cross-section has irregularities. It is further noted that the instant application defines irregularity as variations in the outer contour of the wire (see [0015] of instant application’s specification). Demarais discloses that the wire rod may have a triangular or square cross-section, which also reads on a surface (e.g., outer surface) having irregularities since the cross-section includes variations in the outer contour (e.g., outer contour varies from a flat surface extending linearly in one direction, to a vertex, and then to a flat surface extending linearly in a different direction angled relative to the first).
Demarais discloses the invention substantially as stated above including the wire rod (34) having a structure in which a base wire rod has a polygonal transverse cross section (square, triangular, or ribbon, which is understood to be a rectangular; [0060]), but does not expressly disclose that the base wire rod is spirally twisted, wherein the direction in which the base wire rod is twisted is identical to a winding direction in which the wire rod is wound around the shaft.
Shinozuka discloses that another tissue retrieval device comprising a spirally-arranged protruding portion (11D; figs. 5a-5c) spirally protruding from an outer peripheral surface of a shaft (10). The spirally-arranged protruding portion comprises a wire rod (11D) that is spirally wound around the outer peripheral surface of the shaft (fig. 5A). The wire rod has a polygonal transverse cross-section (see fig. 5B) that is spirally twisted (see fig. 5A-5C) in a direction identical to a winding direction in which the wire rod is wound around the shaft. In particular, see fig. 5A of Shinozuka, noting that the winding direction and twisting direction both have a helix sloping upwards to the right, and thus are both in the clockwise direction when moving from the top end towards the end closest to the label “Fig. 5A”. Shinozuka discloses that this spiral twisting provides a particularly effective drain ditch for viscous material, thus enhancing gripping of the tissue by the wire rod ([0044]). It would have been obvious to one of ordinary skill in the art to have modified the spirally wound wire rod of Demarais to have a polygonal transverse cross section that is spirally twisted as taught by Shinozuka in order to facilitate enhanced gripping of wet or soft tissue by the wire rod, thereby facilitating recovery and transport of wet or soft tissue by rotation of the shaft and the wire rod thereon.
Regarding claim 4, the shaft is a single thread coil or a multi-thread coil ([0059] – coils for forming the inner tube may be constructed as multi-filar coils).
Regarding claim 5, the shaft has, inside thereof, a device lumen in which a medical device (guidewire 120) is insertable.
Regarding claims 6, 14, and 16, the device further comprises a motor (motor drive unit 114) connected to the shaft, wherein the motor is configured to transmit a rotational force to the shaft, thereby rotating the shaft and the spirally arranged protruding portion around an axis ([0068]).
Regarding claims 7, 15, 17, and 18, Demarais discloses an atherectomy device comprising the lesion retrieval device according to claims 1, 4, 5, and 6 as discussed above, and a cutter (cutting member 460, see in fig.11; or macerator 142, see fig. 5A, which breaks up materials into smaller fragments upon rotation and thus is considered to cut the material) provided at a distal end portion of the shaft of the lesion retrieval device, the cutter being configured to excise a body tissue (in the case of 142, helical wire can slice through tissue when rotated).
Regarding claim 11, the shaft is a single thread coil or a multi-thread coil ([0059] of Demarais – coils for forming the inner tube may be constructed as multi-filar coils).
Regarding claim 12, the device further comprises a motor (motor drive unit 114 of Demarais) connected to the shaft, wherein the motor is configured to transmit a rotational force to the shaft, thereby rotating the shaft and the spirally arranged protruding portion around an axis ([0068] of Demarais).
Regarding claim 13, Demarais in view of Shinozuka discloses an atherectomy device comprising the lesion retrieval device of claim 3 as discussed above, and a cutter (cutting member 460, see fig.11 of Demarais; or macerator 142, see fig. 5A of Demarais, which breaks up materials into smaller fragments upon rotation and thus is considered to cut the material) provided at a distal end portion of the shaft of the lesion retrieval device, the cutter being configured to excise a body tissue (in the case of 142, helical wire can slice through tissue when rotated).
Claim(s) 2 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demarais in view of Shinozuka as applied to claim 1 above and further in view of Nishihara (WO 2019175996 A1; citations taken from corresponding Continuation: US 2020/0315641). Demarais in view of Shinozuka discloses the invention substantially as stated above including spirally twisting the polygonal wire rod as taught by Shinozuka. However, Demarais in view of Shinozuka discloses spirally twisting the wire rod in the same direction as the winding direction in which the wire rod is wound around the shaft as discussed above, and thus fails to disclose twisting the base wire rod in a different direction from the winding direction.
Nishihara discloses another tissue retrieval device comprising a spirally arranged protruding side wire (55; fig. 7) spirally protruding from an outer peripheral surface of a shaft (7) used for recovering and transporting tissue and debris from the body ([0036]). Nishihara discloses that the side wire is spirally twisted in a direction different from a winding direction in which the wire is wound around the shaft (clockwise versus counterclockwise; [0069]; fig. 7). Nishihara disclose such an arrangement as a known alternative to a side wire that is spirally twisted in a direction identical to the winding direction (shown in fig. 5; [0052]). It would have been obvious to one of ordinary skill in the art to have further modified the prior art of Demarais in view of Shinozuka to twist the wire rod in a direction different from the winding direction of the wire rod around the shaft in view of Nishihara’s teaching that such an arrangement is a known alternative to identical twisting and winding directions (i.e., both clockwise), and one skilled in the art would have had a reasonable expectation of success with such a modification as both arrangements facilitate recovery and transportation of tissue and debris from the body according to Nishihara.
Regarding claim 8, the shaft is a single thread coil or a multi-thread coil ([0059] of Demarais– coils for forming the inner tube may be constructed as multi-filar coils).
Regarding claim 9, the device further comprises a motor (motor drive unit 114 of Demarais) connected to the shaft, wherein the motor is configured to transmit a rotational force to the shaft, thereby rotating the shaft and the spirally arranged protruding portion around an axis ([0068] of Demarais).
Regarding claim 10, Demarais in view of Shinozuka and Nishihara discloses an atherectomy device comprising the lesion retrieval device of claim 2 as discussed above, and a cutter (cutting member 460, see fig.11 of Demarais; or macerator 142, see fig. 5A of Demarais, which breaks up materials into smaller fragments upon rotation and thus is considered to cut the material) provided at a distal end portion of the shaft of the lesion retrieval device, the cutter being configured to excise a body tissue (in the case of 142, helical wire can slice through tissue when rotated).
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 SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KSH 5/14/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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