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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-19, in the reply filed on 3/26/2026 is acknowledged.
Claim Objections
Claims 7 and 18 are objected to because of the following informalities: “the distal end of the distal tip” should read “a distal end of the distal tip” as this is its first recitation in claims 7 and 18. Appropriate correction is required.
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.
Claim(s) 1-2, 6, 8-13, 17 and 19 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Summers (US 5,431,673). Summers discloses a catheter for removing an object in a body lumen, comprising: an outer tube (12, ending at proximal end of bellows 152; fig. 8); a rotatable drive shaft (30) surrounded by the outer tube; a cutting member (serrated cutting edge 96) connected to a distal end of the drive shaft (fig. 3) to be rotated by the drive shaft with respect to a rotation axis (abstract) and by which the object is cut; a guide wire tube (e.g., 14; fig. 3, noting embodiment of fig. 8 is understood to have similar internal structure to fig. 3) attached to a distal end of the outer tube and having a first guide wire lumen (lumen of guidewire tube 14, which receives drive shaft and guidewire) extending adjacent to the cutting member along the rotation axis (noting a guidewire is inserted into 30); and a distal tip (150 and its attached rounded end in fig. 8,9) attached to a distal end of the guide wire tube (14) (fig. 8) and having a second guide wire lumen (lumen in 150) extending parallel to the rotation axis and communicating with the first guide wire lumen, wherein the drive shaft includes a first curved portion (articulated bellows 152 with 30 therein, when 156 is actuated as in fig. 9) near the distal end of the drive shaft to cause the distal tip (150) to contact a first inner surface (top surface of vessel as viewed in fig. 9) of the body lumen (at tip 150’s proximal end, as result of 152 curving upward in fig. 9) when the first curved portion 152 (at its proximal end) contacts a second inner surface (bottom surface of vessel as viewed in fig. 9) of the body lumen that is on an opposite side of the body lumen with respect to the first inner surface (see fig. 9 and annotated figure below).
Regarding claim 2, the distal tip includes a second curved portion (150) that is curved (fig. 9) to cause a distal end of the distal tip to be directed toward a center of the body lumen (when moving from the proximal end of the tip 150 toward the distal end of the tip, distal tip initially curves away from 1st inner surface toward center of body lumen) when the distal tip contacts the first inner surface of the body lumen (at its proximal end) and the first curved portion (152) contacts the second inner surface of the body lumen (at 152’s proximal end). See the examiner-annotated reproduction of fig. 9 below.
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Regarding claim 11, Summers discloses a medical device for removing an object in a body lumen, comprising: a handle (20) including a motor (22) configured to generate rotation torque; and a catheter (10) ,connectable to the handle (at 72; see fig. 1) and including: an outer tube (12); a drive shaft (30) surrounded by the outer tube and rotatable by the generated rotation torque; a cutting member (86) connected to a distal end of the drive shaft to be rotated by the drive shaft with respect to a rotation axis and by which the object is cut; a guide wire tube (14) attached to a distal end of the outer tube and having a first guide wire lumen (lumen within 14) extending adjacent to the cutting member along the rotation axis; and a distal tip (150 and rounded end attached thereto) attached to a distal end of the guide wire tube (14) and having a second guide wire lumen extending parallel to the rotation axis (noting 140 extending from 150 in fig. 9) and communicating with the first guide wire lumen, wherein the drive shaft includes a first curved portion (152) near the distal end of the drive shaft to cause the distal tip (150) to contact a first inner surface of the body lumen (at distal tip’s proximal end, it contacts upper inner surface of vessel in fig. 9) when the first curved portion contacts a second inner surface of the body lumen that is on an opposite side of the body lumen with respect to the first inner surface (when proximal end of first curved portion 152 contacts lower inner surface of vessel in fig. 9).
Regarding claims 6 and 17, noting that claims 2 and 13 read “the distal tip includes a second curved portion”, the second curved portion can be considered part of the distal tip, such that the second curved portion is located at a distance of 0 mm from a proximal end of the distal tip since it forms the proximal end of the distal tip. In other words, the distal tip is considered second curved portion 150 and the rounded end attached to the distal end of 150 such that the second curved portion forms the proximal end of the distal tip (fig. 9).
Regarding claims 8 and 19, the first curved portion (152) is curved in a first direction (e.g., downward) when viewed from the cutting member (i.e., when looking at the curved portion from the cutting member, i.e., in the proximal direction, the first curved portion curves downward), and the distal tip and the rotation axis of the cutting member is arranged in this order (where “in this order” is understood to refer to the order in which the claim lists the distal tip and the rotation axis, i.e., distal tip first, and then rotation axis) in the first direction (e.g., downward, from top edge of distal tip to rotation axis of cutting member, which is centered in drive shaft 30 and extends downward at 152).
Regarding claim 9, the first guide wire lumen (in 14; fig. 9) is straight, and the second guide wire lumen (in 150) is at least partially curved (fig. 9).
Regarding claim 10, noting that guide wire tube (14) extends just proximal of the distal end of first curved portion (152) since the proximal end of (14) extends over a distal end of the curved portion as understood in view of fig. 3, a proximal end of the first guide wire lumen (lumen of tube 14) is between the distal end of the outer tube (12, which has a distal end at the proximal end of the first curved portion 152) and the first curved portion (152; considering its distal-most end).
Regarding claim 12, wherein the catheter is connectable to the handle via a hub (54,64,72; fig. 1), and the hub includes a knob (72) connected to and rotatable with the outer tube (noting 72 is a catheter retainer cap that threadably connects to 74 and thus can be rotated to remove the catheter from the hub).
Regarding claim 13, the distal tip includes a second curved portion (150) that is curved (fig. 9) to cause a distal end of the distal tip to be directed toward a center of the body lumen (when moving from the proximal end of the tip 150 toward the distal end of the tip, distal tip initially curves away from 1st inner surface toward center of body lumen) when the distal tip contacts the first inner surface of the body lumen (at its proximal end) and the first curved portion (152) contacts the second inner surface of the body lumen (at 152’s proximal end).
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 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Summers in view of Andreas et al. (US 5,250,059). Summers discloses the invention substantially as stated above except the first curved portion being located at the claimed distance from a distal end of the distal tip.
Andreas teaches a similar catheter for removing an object in a body lumen via a rotatable cutter. Andreas teaches that the nose cone (51), analogous to the distal tip (150 and rounded end attached thereto) of Summers, is 20 to 30 mm long and the cutter housing (40), analogous to housing 14 of Summers, is 8 to 17 mm long (col. 4, ll. 67-col. 5, ll. 9 and col. 5, ll. 25-30). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Summers to provide a length of 20-30 mm to the distal tip (150 and rounded end) of Summers and a length of 8 to 17 mm to guide wire tube (cutter housing 14) of Summers since Summers is silent on the dimensions of these elements and Andreas teaches such dimensions as known and suitable for a rotatable cutter catheter having similar structure to that of Summers. Thus, one of ordinary skill in the art would have had a reasonable expectation of success when making the modification. With such a modification, the first curved portion (152) is located a distance of 3mm to 100mm from the distal end of the distal tip (20 + 8 = 28mm, which falls in claimed range).
Allowable Subject Matter
Claims 3-5 and 14-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claims 3-5 and 14-16, because a single wire (154) controls curvature of both the first and second curved portions (152, 150) in fig. 9, the radius of curvature of each of the curved portions is the same as illustrated in fig. 9 and there is no suggestion or motivation in the prior art to modify the device of Summers to provide the first curved portion with a greater radius of curvature than that of the second curved portion.
Conclusion
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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KSH 4/16/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771