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 .
Election/Restrictions
Applicant’s election of Species H/2 (claims 1-13 & 15-20) in the reply filed on 1/14/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/14/2026.
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.
Claims 1-6 & 8 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US Pub. No. 2017/0065295 A1) in view of Simpson (US Pub. No. 2006/0239982 A1).
Regarding claim 1, Patel et al. disclose a medical device (Figs. 20A-B & 21A-B) for removing an object that exists in a body lumen, the medical device comprising: a sheath 2000 (Figs. 20A-B & 21A-B) configured to be inserted into the body lumen; a drive shaft (paragraph [0017]) having a distal portion and a proximal portion, the drive shaft configured to extend through the sheath 2000 (paragraph [0117]); a rotatable hollow rotating body 2003 (discussed in paragraph [0117] as generic ‘103’) located on the distal portion of the drive shaft, and a guide wire lumen 2141 (Figs. 21A-B; paragraph [0150]) into which a guide wire is insertable in parallel with the sheath 2000, the guide wire lumen being located on an outer surface of the sheath 2000 (‘guidewire lumen 2141 can extend along a side of the catheter that is opposite to the cutter’ - paragraph [0150]). Patel et al. fail to further disclose wherein a distal end surface of the rotating body has a concave-convex cut portion formed only between an inner distal end of the hollow rotating body and an outer periphery of the distal end of the hollow rotating body.
However, Simpson teaches a similar rotatable cutting system (Fig. 1) with a sheath 22 and window segment 32 for a rotatable cutter 28 to cut through, wherein Simpson envisions their rotating cutter to have either a smooth edge 64 or a serrated edge 62 (Figs. 9A-9C; paragraph [0120]). Simpson further teaches that the preference of a serrated cutting edge vs a smooth cutting edge is based on the situation (paragraph [0090]). A serrated edge inherently has a concave-convex cut portion formed between an inner distal end and an outer periphery of the distal end. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the teachings and suggestions of Simpson to opt between a smooth edge and a serrated edge to modify Patel et al.’s smooth cutting edge to be serrated when the situation calls for a more aggressive cutting edge.
Regarding claim 2, Patel et al. further disclose wherein the guide wire lumen 2141 is indirectly or directly located on the outer surface of the sheath 2000 (Figs. 21A-B).
Regarding claim 3, Patel et al. further disclose a connection section located between the guide wire lumen 2141 and the rotating body 2003 (Figs. 21A-B show the removed nose cone/guide wire lumen detached from the catheter/sheath 2000 and thus the rotating body 2003, Figs. 20A-B show them connected; therefore, the section shown in Figs. 21A-B is the connection section).
Regarding claim 4, Patel et al. further disclose wherein a distal end of the guide wire lumen 2141 located distal to a distal end of the rotating body (as modified in claim 1 rejection above includes the serrated portion/concave-convex cut portion as the distal cutting edge; the distal cutting edge of rotating body 2003 as shown in Figs. 20A-B is proximal to the distal end of the lumen 2141 since the lumen 2141 extends all the way to the distal end of the nose cone which resides distally to the rotating body 2003).
Regarding claim 5, Patel et al. further disclose wherein the rotating body 2003 has a distal opening and a proximal opening (as seen in the cross sectional view of Fig. 3, generic rotating body 103 has a distal cup opening and proximal opening extending into communication with lumen 113 of the drive).
Regarding claim 6, Patel et al. further disclose a center axis of the distal opening and a center axis of the drive shaft are in a same direction (seem in annotated Fig. 3 below).
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Regarding claim 8, Patel et al. further disclose wherein an area occupied by the distal end surface of the rotating body 2003 (‘103’ in Fig. 3) is greater than an area occupied by a hollow lumen of the rotating body 2003 (shown best in Fig. 3 - distal end surface/cutting end of rotating body 103 occupies a greater area than the proximal hollow lumen portion of the body 103).
Claims 16 & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Savastano et al. (WO 2018/191227 A1) in view of Patel et al. (US Pub. No. 2017/0065295 A1).
Regarding claim 16, Savastano et al. disclose a medical device 10 (Figs. 2, 8A-B, 11F) for removing an object that exists in a body lumen, the medical device comprising: a sheath 14 (Fig. 2) configured to be inserted into the body lumen; a drive shaft having a distal portion and a proximal portion, the drive shaft 56 (Fig. 8B) configured to extend through the sheath 14; a rotatable hollow rotating body 54 (Fig. 8B) located on the distal portion of the drive shaft 56, and wherein a distal end surface of the rotating body 54 has a severing portion 64 (Fig. 8B), the severing portion 64 includes a plurality of concave-convex shaped notches 68 (Fig. 11F) arranged to be twisted in a circumferential direction of the rotating body 54 on the distal end surface of the rotating body 54; and a guide wire lumen 52 (Fig. 7D) configured to receive a guide wire 50, the guide wire lumen 52 being parallel to the sheath lumen (Fig. 7D). Savastano et al. fail to disclose wherein the guide wire lumen is arranged on an outer surface of the sheath.
However, Patel et al. teach a similar medical device having a sheath and a rotatable hollow rotating body with a severing portion (see rejection of claim 1 above), wherein the medical device further comprises a guide wire lumen parallel to the sheath and arranged on an outer surface of the sheath (‘guidewire lumen 2141 can extend along a side of the catheter that is opposite to the cutter’ - paragraph [0150]).
Savastano et al. disclose multiple configurations for the guide wire/guide wire lumen in Figs. 7A-7D (paragraph [50]), one including within the sheath wall. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the outer surface guide wire lumen arrangement taught by Patel et al. for the within the wall guide wire lumen arrangement in Savastano et al.’s device since both lumen arrangements avoid interference with the severing portion and achieve the same sideline guidance for the guidewire relative to the sheath.
Regarding claim 18, Savastano et al. further disclose wherein an area occupied by the distal end surface 64 of the rotating body is greater than an area occupied by a hollow lumen of the rotating body 54 (distal end 64 has a greater outer surface cross sectional area than the cross sectional area of the hollow lumen within the rotating body 54 - Fig. 8A-B).
Allowable Subject Matter
Claims 7, 17, 19, & 20 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.
The following is a statement of reasons for the indication of allowable subject matter: regarding claims 7 & 19, the prior art fails to further disclose, teach, or suggest a connecting member disposed on an outer surface of the sheath, and wherein the connecting member is disposed between the sheath and the guide wire lumen, in combination with the remaining structural elements of the claim; and regarding claim 17, the prior art fails to further disclose, teach, or suggest an insertion member configured to be received within a lumen of the rotating body, the insertion member having a distal member having a distal surface having a crescent shape; and a breaking member that helically extends around the distal member, the breaking member being fixed to an inner surface of the rotating body, in combination with the remaining structural elements of the claim.
Claims 9-15 are allowed (NOTE: claim 14 has been withdrawn, however, since claim 9 is indicated as allowed, claim 14 would also be allowed).
The following is an examiner’s statement of reasons for allowance: Regarding claim 9, Rogers et al. (US Pat. No. 5,733,296) disclose a medical device for removing an object that exists in a body lumen, the medical device comprising: a sheath 102 (Fig. 1) configured to be inserted into the body lumen; a drive shaft 126 (Fig. 1) having a distal portion and a proximal portion, the drive shaft 126 configured to extend through the sheath 102; and a rotatable hollow rotating body 140 (Figs. 1 & 3) located on the distal portion of the drive shaft 126, and wherein a distal end surface of the rotating body includes a severing portion 138, 137 (Fig. 3) is formed between an inner circumference of the rotating body and an outer circumference of the rotating body, the severing portion 138 including at least two different tapered portions 135, 138 (Fig. 3). However, Rogers et al. fail to further disclose, teach, or suggest wherein each of the at least two different tapered portions includes a tapered portion on a distal side having an angle with respect to an axis in a longitudinal direction that is greater than an angle with respect to the axis in the longitudinal direction of a tapered portion on a proximal side. It would not have been obvious to modify each tapered portion 135, 138 to have such angles as claimed since there is no teaching reference to be found to use in combination with Rogers et al. Furthermore, a modification of such would destroy the device when applied to at least tapered portion 135 since this taper intentionally corresponds to a mating taper of the rotating hollow portion proximal side.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 March 7, 2026