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 11/11/25 has been entered. Claims 1, 2, 5- 7, 10 and 17 are amended. Claims 3- 4 are canceled. Claims 1- 2 and 5- 20 are being addressed by this Office Action.
Response to Arguments
It is noted that applicant’s Amendment has changed the scope of the claims, requiring a new rejection.
The Amendment filed 11/11/25 has obviated some of the rejections under 35 U.S.C. 112(b) made in the Non-Final Office Action, mailed 8/12/25. As such, some of the rejections under 35 U.S.C. 112(b) made in the Non-Final Office Action, mailed 8/12/25 are withdrawn.
Applicant's arguments filed 11/11/25 have been fully considered but they are not persuasive.
In response to applicant’s arguments found on p. 7 of applicant’s Remarks, filed 11/11/25, that Plowe does not teach or suggest the newly added limitation regarding “the drive coil adapted to provide consistent feedback via the actuation member regardless of whether the atherectomy tool is implementing retrograde ablation or anterograde ablation” is inapposite. In response to applicant's argument that Plowe does not contemplate the difficulties in switching between anterograde ablation and retrograde ablation, the Office respectfully submits that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. That is to say, if recognizing and/or addressing the inherent difficulties in switching between anterograde and retrograde ablation were patentably distinguishable, then applicant’s claim language should include limitations that result in a structural difference between the claimed invention and the prior art.
Further, it is noted that the language, "the drive coil adapted to provide consistent feedback via the actuation member regardless of whether the atherectomy tool is implementing retrograde ablation or anterograde ablation," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. "The drive coil adapted to provide consistent feedback via the actuation member regardless of whether the atherectomy tool is implementing retrograde ablation or anterograde ablation," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The Office submits that the device of Plowe meets the structural limitations of the claim, and is capable of providing consistent feedback, especially when there is no feedback since never providing feedback is a consistent or expected feedback free from variation.
Claim Objections
Claim 2 is objected to because of the following informalities: “The atherectomy system of claim 1, wherein the the actuation member provides consistent feedback to a user regardless of whether the atherectomy tool is ablating in the anterograde ablation direction or in the retrograde ablation direction” should be amended to - - The atherectomy system of claim 1, wherein the [[the]] actuation member provides consistent feedback to a user regardless of whether the atherectomy tool is ablating in the anterograde ablation direction or in the retrograde ablation direction - - to correct an apparent typographical error. 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.
Claims 17- 20 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.
Amended claim 17 recites “an atherectomy burr” in line 4 and “an atherectomy tool” in line 7. Further, applicant amended original claim 17, line 9 - the atherectomy tool- to “the atherectomy burr.” It is unclear whether the atherectomy burr and the atherectomy tool are the same structural element or whether they are two, separate structural elements. For the purposes of examination, claim 17 is interpreted as reciting a single atherectomy burr - -
An atherectomy system adapted to enable bidirectional ablation, the atherectomy system comprising:
a proximal handle including an actuation member adapted to be movable in a first direction to cause an atherectomy burr to move in an anterograde ablation direction and to be movable in a second direction to cause the atherectomy burr to move in a retrograde ablation direction;
[[an]] the atherectomy [[tool]] burr including a distal region adapted for anterograde ablation and a proximal region adapted for retrograde ablation; and
a drive coil extending between the proximal handle and the atherectomy burr, the drive coil adapted to provide:
a force-torque ratio within a range of -10 gf/mNm to 10 gf/mNm;
a tensile stiffness within a range of 0.5 to 2 N/mm (gage length of 100 mm); and
a compressive stiffness within a range of 3.5 to 5 N/mm (gage length of 10 mm) - - .
Claims 18- 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 17.
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) 10 is/are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Plowe et al. (US Pub. No. 2010/0121361 A1).
Regarding claim 10, Plowe discloses an atherectomy system adapted to enable bidirectional ablation, the atherectomy system comprising:
a proximal handle (10) (Fig. 1) including an actuation member (11) (Fig. 1) adapted to be movable in a first direction in order to implement anterograde ablation and to be movable in a second direction in order to implement retrograde ablation(P. [0047] - - The handle 10 also desirably includes a control knob 11 for advancing and retracting the turbine and drive shaft 20 with respect to the catheter 13 and the body of the handle 10);
an atherectomy tool (28) (Figs. 1- 9) including a distal region (LS) (Figs. 5, 7- 9) adapted for anterograde ablation and a proximal region (DS) (Figs. 5, 7- 9) adapted for retrograde ablation (Ps. [0021], [0068], [0088] - -a drive shaft capable of bi-directional rotation, wherein the abrasive element grinds in one rotational direction and cuts in the other rotational direction; the abrasive section 28 may comprise, in one rotational direction, a grinding or abrasive effect, and in the other rotational direction, a cutting effect. Alternatively, the opposing sides of at least one abrasive element 28 may comprise varying abrasive grit sizes, thereby allowing for less grinding in one rotational direction and more grinding in the other rotational direction; For exemplary purposes only and without limitation, an abrasive section 100 comprising a cutting element may be provided on the leading (distal) section LS of pre-curved section followed by an abrasive section comprising a coating of abrasive material thereon and disposed at pre-curved section peak P); and
a drive coil (20) (Figs. 2- 9) (P. [0044] - - The drive shaft 20 may be, as is well known in the art, constructed from helically coiled wire(s)) extending between the proximal handle (10) and the atherectomy tool (28), the drive coil (20) adapted to provide consistent feedback via the actuation member (11) regardless of whether the atherectomy tool (28) is implementing retrograde ablation or anterograde ablation (it is noted that when no feedback is given in either the anterograde ablation direction or in the retrograde ablation direction, that lack of feedback is a consistent feedback to a user regardless of whether the atherectomy tool (28) is ablating in the anterograde ablation direction or in the retrograde ablation direction, since no feedback is a consistent or expected feedback free from variation).
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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plowe et al. (US Pub. No. 2010/0121361 A1) in view of To et al. (US Pat. No. 11,304,723 B1).
Regarding claim 15, Plowe discloses system of claim 10, but Plowe does not disclose
(claim 15) wherein the drive coil has a bending stiffness that is less than 0.1 N/mm (23 mm span).
However To teaches an atherectomy system in the same field of endeavor (Abstract) having a drive coil (250) (Figs. 2A, 2B)
(claim 15) wherein the drive coil has a bending stiffness that is less than 0.1 N/mm (23 mm span) (See Table 4 - - showing drive shaft flexural stiffness of 0.09-0.26 N/mm) (Col. 21, l, 21- Col. 22, l. 2 - - One of skill will appreciate that the technology provided herein can include flexural stiffness design selections for components to facilitate enhanced performance, maneuverability, and reliability of the atherectomy devices. Flexural stiffness is a measure of deformability expressed in units of N/mm. For example, flexural stiffness may be described as the ability of the component to bend in response to an applied bending force without breaking or deforming the component. For example, one of skill may choose a flexural stiffness of the drive shaft, sheath, or both, in some embodiments, for maneuverability of the atherectomy device to follow a guide wire around tortuous vessels).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the drive coil associated with Plowe such that the drive coil has a bending stiffness that is less than less than 0.1 N/mm (23 mm span) according to the teachings of To because it would facilitate enhanced performance, maneuverability, and reliability of the atherectomy devices (To - - Col. 21, l, 21- Col. 22, l. 2).
Allowable Subject Matter
Claim 2 would be allowable if rewritten to overcome the claim informalities, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 11- 14 and 16 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.
Claims 17- 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 17, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, An atherectomy system adapted to enable bidirectional ablation, the atherectomy system comprising:
a proximal handle including an actuation member adapted to be movable in a first direction to cause an atherectomy burr to move in an anterograde ablation direction and to be movable in a second direction to cause the atherectomy burr to move in a retrograde ablation direction;
[[an]] the atherectomy [[tool]] burr including a distal region adapted for anterograde ablation and a proximal region adapted for retrograde ablation; and
a drive coil extending between the proximal handle and the atherectomy burr, the drive coil adapted to provide:
a force-torque ratio within a range of -10 gf/mNm to 10 gf/mNm;
a tensile stiffness within a range of 0.5 to 2 N/mm (gage length of 100 mm); and
a compressive stiffness within a range of 3.5 to 5 N/mm (gage length of 10 mm) - - .
Reasons for Allowance
Claims 1 and 5- 9 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 1, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, an atherectomy system adapted for both anterograde ablation and retrograde ablation, the atherectomy system comprising: a drive coil that is adapted to provide: an axial force-torque ratio within a range of -50 gf/mNm to 50 gf/mNm; a tensile stiffness within a range of 0 to 5 N/mm (gage length of 100 mm): and a compressive stiffness within a range of 0 to 10 N/mm (gage length of 10 mm);an atherectomy tool coupled to the drive coil, the atherectomy tool including a distal region adapted for anterograde ablation and a proximal region adapted for retrograde ablation; and a proximal handle including an actuation member adapted to be movable in a first direction to urge the atherectomy tool in an anterograde ablation direction and to be movable in a second direction to urge the atherectomy tool in a retrograde ablation direction.
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
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 KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771