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
This office action is responsive to the amendment filed on 10/01/2025. As directed by the amendment: claims 1 and 12 have been amended and claims 14-20 have been cancelled. Thus, claims 1-13 and 21-26 are presently pending in this application with claims 4 and 6-10 remaining withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 12 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.
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.
Claims 1, 12, and 21, 22, 24, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dillard (US 6,569,177 B1).
Regarding claim 1 Dillard discloses (fig. 3-4) an atherectomy device for removing deposits such as plaque from an interior of a vessel (see abstract) comprising:
an outer member 30 having a distal end (see fig. 3);
a rotatable shaft 20 positioned for rotational movement within the outer member 30 (see col. 4 ln. 36-40) and fixed axially within the outer member (the inner and outer members are not disclosed as moveable axially relative to one another), the shaft 20 having a longitudinal axis, a distal region and a distalmost edge (see fig. 3); and
a non-expandable rotatable tip 200 (see col. 4 ln. 36-62) having a proximal end and a distal end (see fig. 3), the proximal end of the rotatable tip 200 positioned distally of the distalmost edge of the outer member 30 to create a gap between the proximal end of the rotatable tip 200 and the distalmost edge of the outer member 30 (see fig. 3), the rotatable tip 200 mounted to the distal region of the rotatable shaft 20 (see fig. 3 and col. 4 ln. 36-40) and having a longitudinal axis and mounted to the rotatable shaft for rotation about its longitudinal axis upon rotation of the rotatable shaft (see col. 5 ln. 4-9), the rotatable shaft 20 including a guidewire lumen for receiving a guidewire 10 to enable over the wire insertion of the device (see col. 4 ln. 2-6 and fig. 3).
Regarding claim 12 Dillard discloses (fig. 3-4) an atherectomy device for removing deposits such as plaque from an interior of a vessel (see abstract) comprising:
an outer member 30 having a distal end (see fig. 3);
a rotatable shaft 20 positioned for rotational movement within the outer member 30 (see col. 4 ln. 36-40) and fixed axially within the outer member (the inner and outer members are not disclosed as moveable axially relative to one another), the shaft 20 having a longitudinal axis, a distal region and a distalmost edge (see fig. 3); and
a non-expandable rotatable tip 200 (see col. 4 ln. 36-62) having a proximal end and a distal end (see fig. 3), the proximal end of the rotatable tip 200 positioned distally of the distalmost edge of the outer member 30 to create a gap between the proximal end of the rotatable tip 200 and the distalmost edge of the outer member 30 (see fig. 3), the rotatable tip 200 mounted to the distal region of the rotatable shaft 20 (see fig. 3 and col. 4 ln. 36-40) and having a longitudinal axis and mounted to the rotatable shaft for rotation about its longitudinal axis upon rotation of the rotatable shaft (see col. 5 ln. 4-9), the rotatable shaft 20 including a guidewire lumen for receiving a guidewire 10 to enable over the wire insertion of the device (see col. 4 ln. 2-6 and fig. 3), the rotating tip 200 having a first portion and a second portion, the first portion being different than the second portion (the rotating tip can be advanced within the vessel to two different positions, see fig. 4-5 and col. 5 ln. 4-34).
Regarding claims 21 and 24 Dillard discloses (fig. 3-4) the rotatable tip is circular in transverse cross-section throughout its length (see fig. 3).
Regarding claims 22 and 25 Dillard discloses (fig. 3-4) the rotatable tip has a distalmost tip 106 with a bullet nose configuration (see fig. 3).
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.
Claims 2, 3, 5, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Dillard in view of Olson (US 2008/0065124 A1).
Regarding claims 2, 3, 5 and 13, Dillard discloses the claimed invention substantially as claimed, as set forth above for claims 1 and 12. Dillard is silent regarding an auger positioned on the rotatable shaft, the auger positioned proximally of the rotatable tip and extending along the rotatable shaft, wherein rotation of the rotatable shaft rotates the auger to move particles macerated by the rotatable tip proximally into the outer member; particles are aspirated through the outer member in the space between the rotatable shaft and an inner wall of the outer member.
However Olson, in the same field of endeavor, teaches (fig. 2) an auger (helical screw) positioned on s rotatable shaft 206 (see fig. 2 and [0041]), the auger positioned proximally of a rotatable tip 203 and extending along the rotatable shaft 206 (see fig. 2), wherein rotation of the rotatable shaft rotates the auger to move particles macerated by the rotatable tip proximally into an outer member (see [0041] and fig. 2); particles are aspirated through the outer member in the space between the rotatable shaft and an inner wall of the outer member (see [0041] and fig. 2).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Dillard to have an auger positioned on the rotatable shaft, the auger positioned proximally of the rotatable tip and extending along the rotatable shaft, wherein rotation of the rotatable shaft rotates the auger to move particles macerated by the rotatable tip proximally into the outer member such that particles are aspirated through the outer member in the space between the rotatable shaft and an inner wall of the outer member, as taught by Olson, for the purpose of being able to help move and compact the plaque (see Olson [0041]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Dillard in view of Guo (US 2002/0099367 A1).
Regarding claim 11, Dillard discloses the claimed invention substantially as claimed, as set forth above for claim 1. Dillard is silent regarding the rotatable tip is positioned proximal of the distalmost edge of the rotatable shaft.
However Guo, in the same filed of endeavor, teaches (fig. 6) a rotatable tip 12 positioned proximal of a distalmost edge of a rotatable shaft 16 (see fig. 6 and [0030]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Dillard to have the rotatable tip is positioned proximal of the distalmost edge of the rotatable shaft, as taught by Olson, for the purpose of being able to infuse liquid past the rotatable tip to a position proximate eth distal end of the shaft (see Guo [0030]).
Claims 23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Dillard in view of Auth (US 4,990,134).
Regarding claims 23 and 26, Dillard discloses the claimed invention substantially as claimed, as set forth above for claims 1 and 12. Dillard is silent regarding the rotatable shaft is electrically powered for high speed rotation.
However Auth, in the same filed of endeavor, teaches a rotatable shaft 16 is electrically powered (via 18) for high speed rotation (see col. 4 ln. 37-40).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Dillard to have the rotatable shaft is electrically powered for high speed rotation, as taught by Auth, for the purpose of being able to treat the lesions in the vessels (see Auth col. 4 ln. 37-45).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5, 11, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, and 15 of U.S. Patent No. 11,547,434 B2 in view of Dillard.
The claims of 11,547,434 claim the limitations of the instant application as set forth below:
Claims of 18082615
Claims of 11,547,434
1
1
2
2
3
3
5
3
11
5
12
15
Claims 1-3, 5, and 15 of U.S. Patent No. 11,547,434 B2 fail to claim that the tip is non-expandable.
However Dillard, in the same filed of endeavor, teaches (fig. 3-4) a non-expandable rotatable tip 200 (see col. 4 ln. 36-62).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify claims 1 and 15 of U.S. Patent No. 11,547,434 to have the tip be a non-expandable tip, as taught by Dillard, for the purpose of having a tip that reduces irritation to the vessel wall (see Dillard col. 2 ln. 39-43).
Claims 21 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,547,434 B2 in view of Dillard and Guo.
Regarding claims 21 and 22, claim 1 of U.S. Patent No. 11,547,434 as modified claims the limitations of claim 1 but fails to claim the rotatable tip is circular in transverse cross-section throughout its length; rotatable tip has a distalmost tip with a bullet nose configuration.
However Guo, in the same filed of endeavor, teaches (fig. 6) a rotatable tip 12 that is circular in transverse cross-section throughout its length (see fig. 6); rotatable tip has a distalmost tip (distal end of 12) with a bullet nose configuration (see fig. 6).
Therefore, the substitution of one known tip (circular cross section with bullet nose configuration as taught in Guo) for another (as claimed in claim 1 of U.S. Patent No. 11,547,434) would have been obvious to one of ordinary skill in the art at the time of the invention since the tip as taught in Guo would have yielded predictable results, namely, a tip that cuts plaque. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,547,434 B2 in view of Dillard and Mische.
Regarding claim 23, claim 1 of U.S. Patent No. 11,547,434 as modified claims the limitations of claim 1 but fails to claim the rotatable shaft is electrically powered for high speed rotation.
However Mische, in the same filed of endeavor, teaches a rotatable shaft is electrically powered for high speed rotation (see col. 18 ln. 46-58).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify claim 1 of U.S. Patent No. 11,547,434 to have a rotatable shaft is electrically powered for high speed rotation, as taught by Mische, for the purpose of being able to rotate the tip to cut plaque (see Mische col. 18 ln. 46-58).
Claims 24 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,547,434 B2 in view of Dillard and Guo.
Regarding claims 24 and 25, claim 15 of U.S. Patent No. 11,547,434 as modified claims the limitations of claim 12 but fails to claim the rotatable tip is circular in transverse cross-section throughout its length; rotatable tip has a distalmost tip with a bullet nose configuration.
However Guo, in the same filed of endeavor, teaches (fig. 6) a rotatable tip 12 that is circular in transverse cross-section throughout its length (see fig. 6); rotatable tip has a distalmost tip (distal end of 12) with a bullet nose configuration (see fig. 6).
Therefore, the substitution of one known tip (circular cross section with bullet nose configuration as taught in Guo) for another (as claimed in claim 12 of U.S. Patent No. 11,547,434) would have been obvious to one of ordinary skill in the art at the time of the invention since the tip as taught in Guo would have yielded predictable results, namely, a tip that cuts plaque. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,547,434 B2 in view of Dillard and Mische.
Regarding claim 26, claim 15 of U.S. Patent No. 11,547,434 claims as modified the limitations of claim 12 but fails to claim the rotatable shaft is electrically powered for high speed rotation.
However Mische, in the same filed of endeavor, teaches a rotatable shaft is electrically powered for high speed rotation (see col. 18 ln. 46-58).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify claim 15 of U.S. Patent No. 11,547,434 to have a rotatable shaft is electrically powered for high speed rotation, as taught by Mische, for the purpose of being able to rotate the tip to cut plaque (see Mische col. 18 ln. 46-58).
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 KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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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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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771