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 Invention I, claims 1-15, Species A, figures 1-8J, in the reply filed on February 2, 2026 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 2, 2026. Applicant’s argument is that claim 16 recites the substantially similar structure as recited in independent claim 1 and that there would be no additional search burden, however, the search of the method would further include searching for the advancement of the guide wire as well as specifically the step of increasing the effective diameter of the abrasive element by rotating the driveshaft and causing it to pivot, which is not recited in the device claims, whereas the device claims would require a further search in classes not limited to just atherectomy devices for the same features. Therefore, applicant’s arguments are not persuasive.
Claim Rejections - 35 USC § 102
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 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, 7-10, 12, 14, 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Welty et al (US 20090306689).
Regarding claim 1, Welty discloses an atherectomy device comprising: a driveshaft (102) advanceable through a bodily lumen; and an abrasive element (100) coupled to the driveshaft, the abrasive element comprising a generally cylindrical body (101) having a lumen formed therethrough (figure 8A), wherein the driveshaft extends through the lumen and the abrasive element is affixed to the driveshaft via a pivot (105A, 105B), such that the abrasive element is radially pivotable about the driveshaft (figure 8A-8C).
Regarding claim 2, Welty discloses all of the limitations set forth in claim 1, wherein the abrasive element comprises: a first end portion (108B/109B) having a first radially offset center of mass offset from an axis of the lumen in a first radial direction; and a second end portion (108A/109A) having a second radially offset center of mass offset from the axis of the lumen in a second radial direction opposite from the first radial direction (figure 8A).
Regarding claim 4, Welty discloses all of the limitations set forth in claim 1, wherein the pivot is located at an approximate center of the abrasive element (105A, 105B is approximately at the center of 109A, 109B).
Regarding claim 6, Welty discloses all of the limitations set forth in claim 1, wherein the abrasive element comprises a proximal notch (at 105A) formed at a proximal end of the abrasive element and a distal notch (at 107A, opening for pivot) formed at a distal end of the abrasive element.
Regarding claim 7, Welty discloses all of the limitations set forth in claim 1, wherein the abrasive element comprises a waist disposed between a first end portion and a second end portion (107B, 107A, figure 8B).
Regarding claim 8, Welty discloses all of the limitations set forth in claim 1, wherein the abrasive element has an eccentric shape (figure 8A).
Regarding claim 9, Welty discloses all of the limitations set forth in claim 1, wherein the driveshaft is configured to be advanced over and rotated (paragraph 0072) about a guide wire (guide wire, paragraph 0067).
Regarding claim 10, Welty discloses all of the limitations set forth in claim 1, wherein the abrasive element includes an exterior surface that is rough compared to exterior surfaces (griding surface, 110A, 110B) of the driveshaft (paragraph 0072).
Regarding claim 12, Welty discloses an atherectomy system comprising: an atherectomy device comprising: a driveshaft (102) advanceable through a bodily lumen; and an abrasive element (100) coupled to the driveshaft, the abrasive element comprising a generally cylindrical body (101) having a lumen formed therethrough, wherein the driveshaft extends through the lumen and the abrasive element is affixed to the driveshaft via a pivot (105A, 105B), such that the abrasive element is radially pivotable about the driveshaft; and a sheath (101) operable to maintain the abrasive element in a constrained configuration, wherein when advanced out of the sheath to an unconstrained configuration an effective diameter of the abrasive element increases (figures 8C to 8A).
Regarding claim 14, Welty discloses all of the limitations set forth in claim 12, wherein the abrasive element comprises: a first end portion (108B/109B) having a first radially offset center of mass offset from an axis of the lumen in a first radial direction; and a second end portion (108A/109A) having a second radially offset center of mass offset from the axis of the lumen in a second radial direction opposite from the first radial direction (figure 8A).
Regarding claim 15, Welty discloses all of the limitations set forth in claim 12, further comprising a guide wire, wherein the driveshaft is configured to be advanced over and rotated about the guide wire (paragraph 0031, 0069).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Welty et al (US 20090306689) as applied to claim 1 above.
Regarding claim 11, Welty discloses all of the limitations set forth in claim 1, wherein a first end portion (108A/109A) and a second end portion (108B/109B)of the abrasive element are larger than a remainder of the abrasive element (figure 8A), but does not specifically disclose that the first and second end portions have a higher density than a remainder of the abrasive element. However, Welty teaches it was known in the art at the time of the invention to adjust the masses of the first end portion and the second end portions of the disclosed abrasive elements in order to modify the center of mass with respect to the rotational axis of the drive shaft (paragraph 0039, 0054) for a desired effect. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the already enlarged first and second end portion comprise a material of a higher density than a remainder of the abrasive element in order to adjust the center of mass accordingly as desired, as suggested by the prior art, since it has been held to be within the general skill of a worker in the art to select a known material, such as one with a higher density, on the basis of its suitability for the intended use, In re Leshin, 125 USPQ 416.
Regarding claim 13, Welty discloses all of the limitations set forth in claim 12, wherein the effective diameter increases relative to the constrained configuration (figures 8A-8C, paragraph 0019, 0044), but does not specifically disclose the effective diameter increases between about 10% to about 60%. However, Welty discloses it was known in the art at the time of the invention to adjust the effective diameter increase of the abrasive element with respect to the constrained configuration (paragraph 0048, extending movement only to a particular angle relative to the drive shaft). Therefore, since it has been held that where the general conditions of a claim are disclosed in the prior art (amount of extension radially relative to the constrained configuration), discovering the optimum or workable ranges involves only routine skill in the art, it would have been within the level of one with ordinary skill in the art at the time of the invention to modify the effective diameter increase of the abrasive element to be between 10%-60% relative to the constrained configuration when the drive shaft is rotated.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Welty et al (US 20090306689) as applied to claim 1 above, and further in view of Wlodarski et al (US 20150164514).
Regarding claim 3, Welty discloses all of the limitations set forth in claim 1, but does not disclose the pivot is a weld. However, Wlodarski discloses it was known in the art at the time of the invention for a joint and pivot to comprise a weld (paragraph 0431) as an art-recognized equivalent engagement or joint feature to a pin. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the pivot of Welty a weld, as taught as an art-recognized equivalent joint mechanism at the time of the invention by Wlodarski, since it has been held that mere substitution of art-recognized equivalents at the time of the invention involve routine skill in the art.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Welty et al (US 20090306689) as applied to claim 1 above, and further in view of Wlodarski et al (US 20150164514).
Regarding claim 5, Welty discloses all of the limitations set forth in claim 1, but does not disclose the pivot is an adhesive coupling. However, Wlodarski et al (hereafter Wlodarski) teaches it was known in the art at the time of the invention to join a hinged arm to a hinge pin including an adhesive coupling (paragra0034). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to include an adhesive coupling on the pivot of Welty, as an known art-recognized securement mechanism for hinged arms and hinged pins at the time of the invention by Wlodarski, and it has been held that mere substitution of art-recognized equivalents at the time of the invention involves routine skill in the art.
Conclusion
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/ANH T DANG/Primary Examiner, Art Unit 3771