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 .
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.
Claim(s) 7, 13, 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6494890 to Shturman et al. (Shturman) in view of Us 6,129,731 to Shturman et al. (Shturman II).
Shturman teaches:
Claim 7: A drive shaft for a rotational atherectomy device comprising: a metallic coil (20, Fig. 3) comprising one or more wound wire filars, wherein the metallic coil defines a lumen (where 15 is inserting through, Fig. 3) therethrough; an outer polymer layer (22, Fig. 3) surrounding at least a portion of the length of the metallic coil (20,Fig. 3) and creating a multi-layer drive shaft portion (layer 22 and layer 20, Fig. 3), wherein at least part of the outer polymer layer fills and closes the gaps between the adjacent windings of the wound wire filars within the at least a portion of the length of the metallic coil to prevent fluid passage to and from the lumen defined by the at least a portion of the length of the metallic coil (the portion where coating 22, which is a polymer layer, covers would prevent fluid from passing through), and wherein the outer polymer layer is connected with the one or more wound filars of the metallic coil such that the outer polymer layer and the metallic coil rotate together (the coating 22 and drive shaft 20 would rotate together because the coating 22 is coated to the outer surface of the drive shaft 20). Claim 15: The outer polymer layer adds to a spring constant value of the rotational drive shaft with the outer polymer layer. (A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). (Shturman discloses the structurally outer polymer layer as claimed and therefore it is said that the outer polymer of Shturman would also function the same or have the same characteristic as the outer polymer layer of the instant application).
Claim 16: The outer polymer layer reduces at least one of longitudinal elongation, jumping and/or compression of the metallic coil during drive shaft insertion within a patient's body and high-speed rotation of the flexible driveshaft. (A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). (Shturman discloses the structurally outer polymer layer as claimed and therefore it is said that the outer polymer of Shturman would also function the same or have the same characteristic as the outer polymer layer of the instant application).
Claim 17: A drive shaft for a rotational atherectomy device comprising: a metallic coil (20, Fig. 3) comprising one or more wound wire filars, wherein the metallic coil defines a lumen (where 15 is inserting through, Fig. 3) therethrough; an outer polymer layer (22, Fig. 3) surrounding at least a portion of the length of the metallic coil and creating a multi-layer drive shaft portion (layer 22 and layer 20, Fig. 3), wherein at least part of the outer polymer layer fills and closes the gaps between the adjacent windings of the wound wire filars within the at least a portion of the length of the metallic coil to prevent fluid passage to and from the lumen defined by the at least a portion of the length of the metallic coil (the portion where coating 22, which is a polymer layer, covers would prevent fluid from passing through), and wherein the outer polymer layer is connected with the one or more wound filars of the metallic coil such that the outer polymer layer and the metallic coil rotate together (the coating 22 and drive shaft 20 would rotate together because the coating 22 is coated to the outer surface of the drive shaft 20).
Shturman fails to teach:
Claim 7: A connector for connection between the outer polymer layer and a prime mover drive shaft of a prime mover device, wherein the connector is operatively connected with the metallic coil and the outer polymer layer of the drive shaft.
Claim 13: The coupler comprises a wall and an axial lumen and the coupler further comprises at least one opening through the coupler wall.
Claim 17: A connector for providing an operative connection between the polymer layer and a prime mover drive shaft of a prime mover device, wherein the connector is operatively connected with the metallic coil and the outer polymer layer of the drive shaft.
Shturman II teaches:
Claim 7: In the same field, a rotational atherectomy device with radially expandable prime mover coupling comprise a connector (150, Fig. 26) for connection between the drive shaft (60, Fig. 26) and a prime mover drive shaft (200, Fig. 26) of a prime mover device, wherein the connector is operatively connected with the metallic coil and the outer polymer layer of the drive shaft (the connector 150 is operatively coupled to the drive shaft 60, and the drive shaft 60 is connected to the polymer layer in view of Shturman, therefore, it is said that the connector is operatively connected to both the metallic coil and the outer polymer layer of the drive shaft).
Claim 13: The coupler/connector (150, Fig. 26) comprises a wall and an axial lumen (where 170 inserting through, Fig. 26) and the coupler further comprises at least one opening (158, Fig. 26) through the coupler wall.
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to modify the connector and coupling as taught by Shturman II into Shturman in order to facilitate and provision of an exchangeable drive shaft.
Claim(s) 8, 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shturman in view of Shturman II and further in view of US 2014/0193474 to Babcock et al. (Babcock).
Shturman in view of Shturman II teaches:
The drive shaft of claim 7 (see rejection of claim 7 above).
Claim 10: A tool fixedly attached to the metallic tool (28, Fig. 4).
Claim 11: The tool comprises an abrasive element (28, Fig. 4).
Claim 12: The tool comprises one or more of the group consisting of: an eccentric crown (28, Fig. 4, para. 0060).
Shturman in view of Shturman II fails to teach:
An inner polymer layer disposed within the lumen of the metallic coil, the inner polymer layer comprising a different polymer than the outer polymer layer and defining an axial lumen therethrough and an inner surface that is generally smooth and continuous.
Babcock teaches:
Low particulate lubricious coating with vinyl pyrrolidone and acidic polymer-containing layers comprising coating the acrylic acid polymer on the outer surface, inner surface or both to the tube. (para. 0173)
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to coat inner lumen of the metallic coil with polymer layer as taught by Babcock in order to have a smooth surface and reduce particulate generation (para. 0002).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shturman in view of Shturman Il and further in view of US 2010/0121361 to Plowe et al. (Plowe).
Shturman in view of Shturman II teaches:
The drive shaft of claim 7 (see rejection of claim 7 above).
Shturman in view of Shturman Il fails to teach:
Claim 9: A marker band comprising a wall and fixedly attached to, and at least partially surrounding, the metallic coil.
Plowe teaches:
In the same field as endeavor, directional rotational atherectomy device with offset spinning abrasive element comprises markers band (which would fixedly attached to and surrounding the coil) proximate the abrasive section (28, Fig. 8, para. 87).
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to modify a marker band as taught by Plowe into Shturman in order to determine the location of the device inside the body.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shturman in view of Shturman Il and further in view of US 2007/0233175 to Zaver et al. (Zaver).
Shturman in view of Shturman Il teaches:
The drive shaft of claim 7 (see rejection of claim 7 above).
Shturman in view of Shturman Il fails to teach:
The outer polymer layer comprises one or more of the group consisting of: nylon, PEEK, and polyimide.
Zaver teaches:
A medical device comprises a band (93, 93a, Figs. 8A-E, para. 0082) that made from polyimide, PEEK or nylon that may be shrink on application of heat.
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to employ the outer polymer layer made from polyimide, PEEK or nylon taught by Zaver into Shturman since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use; MPEP 2144.07 Art Recognized Suitability for an Intended Purpose, In re Leshin, * > 277 < F.2d 197, 125 USPQ 416 (CCPA 1960).
Response to Arguments
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive. The applicant argued that Shturman II discloses a pair of carriages for a drive shaft and prime mover and has nothing to do with multi-layer drive shaft where connection is between multi-layers as part of a drive shaft drive train. This is not persuasive. Shturman II is to shown a connection between the drive shaft and the prime mover via a connector/cartridge and the multi-layer drive shaft is already taught by Shturman as the primary reference. The drawing in figure 6 of the instant application only show that the polymer drive shaft being connected with the prime mover drive shaft via the connector 150. The combination of Shturman and Shturman II also shown the multi-layer drive shaft of Shturman being connected with the prime mover drive shaft 200 of via connector 150 of Shturman II. As for the argument that Shturman II does not disclose overlap of drive shaft layers having an outer polymer layer surrounding a portion of the length of the metallic coil for creating a multi-layer drive shaft portion. This is also not persuasive. The examiner’s position is that the coil and the polymer as shown in rejection of claim 7 above clearly shown two layers, the polymer layer and the coil layer.
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 PHONG SON DANG whose telephone number is (571)270-5809. The examiner can normally be reached Mon-Fri 8-5.
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/PHONG SON H DANG/Primary Examiner, Art Unit 3771
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