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 05/13/26 has been entered. Claims 1, 9, and 14 have been amended, claims 3, 7-8, 12, and 16 have been cancelled, and new claims 20-23 have been entered. Claims 1-2, 4-6, 9-11, 13-15, and 17-23 are addressed in the following office action.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-6, 9-11, 13-15, and 17-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evans et al. (US 2002/0010487), cited in previous office action.
Regarding claim 1, an invention relating to a surgical cutting device, Evans discloses (Figs. 1-4 & 17) a medical device (10) configured to be positioned in a living body lumen (Abstract), comprising: a rotatable shaft (32) possessing distal and proximal portions; a plurality of struts (18 & 30) that extend along a central axis (see annotated figure below) of the rotatable shaft and arranged around the central axis with an interval (Par. 0051), the plurality of struts having a distal end [i.e. the end of elements 30 that are affixed at the distal portion (26)] and a proximal end [i.e. the end of elements 30 that are affixed at the proximal portion (24)], and each of the plurality of struts bridging between the distal end and the proximal end (Par. 0051); the plurality of struts being deformable in correspondence with two states, the two states being a contraction state [i.e. low profile configuration] and an expansion state [i.e. larger profile configuration]; in the contraction state, the distal end and the proximal end of the plurality of struts are most distant in the axial direction; and in the expansion state, the distal end and the proximal end of the plurality of struts are brought closer in the axial direction such that central portions of the plurality of struts are expanded in a radial direction of the central axis (Par. 0052-0053); wherein each of the plurality of struts includes a plurality of spaced apart protrusions (94) that project outwardly from a strut forming a plurality of portions having a width in a circumferential direction that is wider than that of an adjacent portion (see annotated figure below & Par. 0073), and wherein, each of the plurality of protrusions on a side surface of the strut [i.e. protrusions on one of the struts of element 18] is shifted from a protrusion on a side surface of an adjacent strut [i.e. protrusion on another of the struts of element 18] along an axis of the plurality of struts [i.e. along an axis, colinear with the central axis, each of the plurality of protrusions on one strut of element 18 are shifted from protrusions on another strut of element 18 because the struts are spaced apart] (see annotated figure below).
PNG
media_image1.png
225
557
media_image1.png
Greyscale
PNG
media_image2.png
285
295
media_image2.png
Greyscale
PNG
media_image3.png
156
568
media_image3.png
Greyscale
Regarding claim 2, Evans discloses the medical device according to claim 1. Evans further discloses wherein the rotatable shaft possesses an outer surface (see annotated figure below), the rotatable shaft including the cutting member disposed at the distal portion of the rotatable shaft (Fig. 10); and the distal end of the plurality of struts being attached to a distal side of the rotatable shaft, the plurality of struts configured to rotate around the central axis in correspondence with a rotation of the rotatable shaft (Par. 0055 & 0064-0065).
PNG
media_image4.png
225
557
media_image4.png
Greyscale
Regarding claim 4, Evans discloses the medical device according to claim 1. Evans further discloses (Fig. 10) wherein the rotatable shaft comprises an inner elongated tubular shaft (32) possessing an outer surface (see annotated figure below), the inner elongated tubular shaft including the cutting member disposed at the distal portion of the inner elongated tubular shaft (Par. 0064-0065).
Regarding claim 5, Evans discloses the medical device according to claim 4. Evans further discloses wherein the distal end of the plurality of struts is attached to a distal side of the inner elongated tubular shaft (Par. 0065).
Regarding claim 6, Evans discloses the medical device according to claim 1. Evans further discloses wherein in the expansion state, the distal end and the proximal end of the plurality of struts are brought closer in the axial direction such that central portions of the plurality of struts expanded in a radial direction of the central axis (Par. 0055 & 0064-0065).
Regarding claim 9, an invention relating to a surgical cutting device, Evans discloses (Figs. 1-4, 7, 10) a medical device (10) configured to be positioned in a living body lumen (Abstract), comprising: a rotatable shaft (32) possessing distal and proximal portions, the rotatable shaft possessing an outer surface (see annotated figure below), the rotatable shaft including a cutting member (18) disposed at the distal portion of the rotatable shaft (Par. 0064-0065); the cutting member having a plurality of struts (30) that extend along an central axis (see annotated figure below) of the rotatable shaft and are arranged around the central axis with an interval (Par. 0051), the plurality of struts having a distal end [i.e. the end of elements 30 that are affixed at the distal portion (26)] and a proximal end [i.e. the end of elements 30 that are affixed at the proximal portion (24)], each of the plurality of struts bridging between the distal end and the proximal end (Par. 0051); the distal end of the plurality of struts being attached to a distal side of the rotatable shaft, the plurality of struts configured to rotate around the central axis in correspondence with a rotation of the rotatable shaft (Par. 0055 & 0065); the plurality of struts being deformable in correspondence with two states, the two states being a contraction state [i.e. low profile configuration] and an expansion state [i.e. larger profile configuration]; in the contraction state, the distal end and the proximal end of the plurality of struts are most distant in the axial direction; in the expansion state, the distal end and the proximal end of the plurality of struts are brought closer in the axial direction such that central portions of the plurality of struts are expanded in a radial direction of the central axis (Par. 0052-0053); and in the expansion state, each of the plurality of struts has a first tilting portion (see annotated figure below) that tilts in a first rotation direction proximally of a portion (see annotated figure below) where an outer diameter of the struts are maximized in the expansion state and a second tilting portion (see annotated figure below) that tilts in opposite direction of the first tilting portion, and wherein when the plurality of struts is brought into the expansion state, the first tilting portion and the second tilting portion tilt to the central axis at an angle and having an asymmetrical shape [i.e. the first and second tilting portions have different helical wind angle] (Par. 0060).
PNG
media_image4.png
225
557
media_image4.png
Greyscale
PNG
media_image5.png
231
463
media_image5.png
Greyscale
Regarding claim 10, Evans discloses the medical device according to claim 9. Evans further discloses wherein the plurality of struts in the contraction state have a substantially linear shape (Fig. 7), and the plurality of struts in the expansion state are deformed and bend radially outward (Fig. 2).
Regarding claim 11, Evans discloses the medical device according to claim 9. Evans further discloses (Fig. 17) wherein the plurality of struts include edge portions that form blades [i.e. serrated circumferential surfaces (94)] configured to cut substances in the living body lumen (Par. 0073).
Regarding claim 13, Evans discloses the medical device according to claim 9. Evans discloses further comprising: a linear motion shaft (see annotated figure below), the linear motion shaft configured to adjust a deformation amount of the plurality of struts; a distal tube, the distal tube being on a distal side of the cutting unit and fixed to a distal side of the linear motion shaft (Par. 0055 & 0064-0065); and an outer sheath configured to accommodate the cutting unit (Par. 0052).
PNG
media_image6.png
282
452
media_image6.png
Greyscale
Regarding claim 14, an invention relating to a surgical cutting device, Evans discloses (Figs. 1-4, 7, 10, 17) a medical device (10) configured to be positioned in a living body lumen (Abstract), comprising: a rotatable shaft (32) possessing distal and proximal portions, the rotatable shaft possessing an outer surface (see annotated figure below), the rotatable shaft including a cutting member (18) disposed at the distal portion of the rotatable shaft (Par. 0064-0065); the cutting member having a plurality of struts (30) that extend along a central axis (see annotated figure below) of the inner elongated tubular shaft and are arranged around the central axis with an interval (Par. 0051), the plurality of struts having a distal end [i.e. the end of elements 30 that are affixed at the distal portion (26)] and a proximal end [i.e. the end of elements 30 that are affixed at the proximal portion (24)], each of the plurality of struts bridging between the distal end and the proximal end (Par. 0051); the distal end of the plurality of struts being attached to a distal side of the inner elongated tubular shaft (Par. 0055 & 0065); the plurality of struts being deformable in correspondence with two states, the two states being a contraction state [i.e. low profile configuration] and an expansion state [i.e. larger profile configuration]; in the contraction state, the distal end and the proximal end of the plurality of struts are most distant in the axial direction; in the expansion state, the distal end and the proximal end of the plurality of struts are brought closer in the axial direction such that central portions of the plurality of struts expanded in a radial direction of the central axis (Par. 0052-0053); and wherein each of the struts includes a plurality of spaced apart protrusions (94) that project outwardly from the strut forming a plurality of portions (see annotated figure below) having a width in a circumferential direction that is wider than that of an adjacent portion (see annotated figure below), and the width in the circumferential direction of the plurality of portions being wider on both circumferential sides of each of the struts [Note, the width in the circumferential direction of the strut will be wider at the peaks of the protrusions than at the valleys of the protrusions] (Par. 0073).
PNG
media_image4.png
225
557
media_image4.png
Greyscale
PNG
media_image7.png
291
325
media_image7.png
Greyscale
Regarding claim 15, Evans discloses the medical device according to claim 14. Evans further discloses wherein the plurality of struts in the contraction state have a substantially linear shape (Fig. 7), and the plurality of struts in the expansion state are deformed and bend radially outward (Fig. 2).
Regarding claim 17, Evans discloses the medical device according to claim 14. Evans further discloses (Fig. 17) wherein the plurality of spaced apart protrusions that project outwardly away from the strut include a blade [i.e. serrated circumferential surfaces (94)] configured to cut the substances (Par. 0073).
Regarding claim 18, Evans discloses the medical device according to claim 14. Evans further discloses wherein a rotation direction of the rotatable shaft is same as a sharp direction of the protrusion (Par. 0073).
Regarding claim 19, Evans discloses the medical device according to claim 14. Evans discloses further comprising: an outer sheath configured to accommodate the cutting unit (Par. 0052).
Regarding claim 20, Evans discloses the medical device according to claim 1. Evans discloses wherein a number of the plurality of protrusions on a side surface of the strut is different from a number of the plurality of protrusions on a side surface of an adjacent strut [i.e. the protrusions on a strut of element 18, located closer to the distal end of the basket, have a different helical wind angle than the protrusions on another strut of element 18, located closer to the middle of the basket, and thus are different] (Par. 0060). Note, “a number of” is being interpreted as “one or more of”.
Regarding claim 21, Evans discloses the medical device according to claim 14. Evans further discloses wherein the plurality of spaced apart protrusions extend along an extending direction of the plurality of struts and on a further distal side from a portion where an outer diameter of the plurality of struts are maximized in the expansion state [i.e. protrusion on the distal portion of struts on element 18] (Par. 0073).
Regarding claim 22, Evans discloses the medical device according to claim 14. Evans further discloses wherein the plurality of protrusions are same shape (Fig. 17).
Regarding claim 23, Evans discloses the medical device according to claim 14. Evans further discloses wherein the plurality of protrusions on a first side surface of the strut is shifted from a protrusion on a first side surface of an adjacent strut along an axis of the plurality of struts [i.e. along an axis 52 each of the plurality of protrusions on one strut of element 18 are shifted from protrusions on another strut of element 18 because the struts are spaced apart] (see annotated figure below).
PNG
media_image3.png
156
568
media_image3.png
Greyscale
Response to Arguments
Applicant's arguments filed 05/13/26 have been fully considered but they are not persuasive.
Applicant argues previously cited prior art reference Evan’s serrated circumferential surfaces 94 are arranged on only one side, rather than the width in the circumferential direction of the plurality of portions being wider on both circumferential sides of each of the struts as recited in claim 14 as amended; and the serrated circumferential surfaces 94 are not shifted from a protrusion on a side surface of an adjacent strut along an axis of the plurality of struts as recited in claim 1 as amended. Examiner respectfully disagrees. Refer to the rejections of claims 1 and 14 above which explain how Evans discloses the newly recited limitations.
Also, applicant argues Evans does not disclose or suggest a second tilting portion that tilts in opposite direction of the first tilting portion, the second titling portion being located on the portion where the outer diameter of the struts are maximized in the expansion state, and wherein when the plurality of struts is brought into the expansion state, the first tilting portion and the second tilting portion tilt to the central axis at an angle and having an asymmetrical shape as recited in claim 9 as amended. Examiner respectfully disagrees. Refer to the rejection of claim 9 above which explains how Evans discloses the newly recited limitation.
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 Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.U.I/ Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
Prosecution Insights