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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 15 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 15 recites “a spring constant value of the rotational drive shaft”. This limitation lack written description in the specification.
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.
Claim 12 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.
Claim 12 recites the limitation "the tool" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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, 15-17 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, 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, 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 drive shaft 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 drive shaft 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, 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 (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.
Claim(s) 8 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).
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) 9-11 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 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).
Claim 10: A tool fixedly attached to the metallic tool (24, Fig. 3).
Claim 11: The tool comprises an abrasive element (24, Fig. 3).
Shturman in view of Shturman II 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 II and further in view of US 2007/0233175 to Zaver et al. (Zaver).
Shturman in view of Shturman II teaches:
The drive shaft of claim 7 (see rejection of claim 7 above).
Shturman in view of Shturman II 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 with respect to claim(s) 7-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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