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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/04/2026 has been entered.
This office action is responsive to the amendment filed on 05/04/2026. As directed by the amendment: claims 1 and 12 have been amended and claims 3, 5, and 14-20 have been cancelled. Thus, claims 1-2, 4, 6-13, and 21-26 are presently pending in this application with claims 4 and 6-10 withdrawn.
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, 2, 11-13, 21, 22, 24, and 25 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-5 of U.S. Patent No. 11,547,434 in view of Wulfman-843 et al. (US 5,584,843) and Wulfman-190 et al. (US 20020007190 A1).
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
3, 4
2
3 (in claim 2 which 3 depends from)
11
5
12
3, 4
13
3 (in claim 2 which 3 depends from)
Claims 3-5 of U.S. Patent No. 11,547,434 B2 fail to claim the outer member including a hub configured for connection to an aspiration source; the tip is non-expandable; the distal end having a cross sectional dimension less than a cross-sectional dimension of the proximal end and the proximal end having a uniform cross-sectional dimension.
However Wulfman-843, in the same filed of endeavor, teaches (fig. 5 and 7) the tip is non-expandable (see fig. 7); the distal end having a cross sectional dimension less than a cross-sectional dimension of the proximal end and the proximal end having a uniform cross-sectional dimension (see fig. 7).
Therefore, the substitution of one known tip (non-expandable; the distal end having a cross sectional dimension less than a cross-sectional dimension of the proximal end and the proximal end having a uniform cross-sectional dimension as taught in Wulfman-843) for another (as taught in 11,547,434) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since Wulfman-843 teaches that the tip shape is suitable for an abrasive tip and the substitution of the shape as taught in Wulfman-843 would have yielded predictable results, namely, a tip that cuts through plaque. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Wulfman-190, in the same filed of endeavor, teaches (fig. 5) the outer member 40 including a hub (hub with 604) configured for connection to an aspiration source (see fig. 5 and [0083]).
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 3 and 4 of U.S. Patent No. 11,547,434 to have the outer member including a hub configured for connection to an aspiration source, as taught by Wulfman-190, for the purpose of being able to remove debris from the vessel during treatment (see Wulfman-190 [0083]).
Regarding claims 21, 22, 24, and 25 claims 3 and 4 of U.S. Patent No. 11,547,434 as modified claims the limitations of claims 1 and 12. Wulfman-843 further teaches the rotatable tip 63 is circular in transverse cross-section throughout its length; rotatable tip has a distalmost tip with a bullet nose configuration (see fig. 7).
Claims 23 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 4 of U.S. Patent No. 11,547,434 B2 in view of Wulfman-843, Wulfman-190 and Mische.
Regarding claims 23 and 26, claims 3 and 4 of U.S. Patent No. 11,547,434 as modified claims the limitations of claims 1 and 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 claims 3 and 4 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).
Allowable Subject Matter
Claims 1, 2, 11-13, and 21-26 would be allowable if a terminal disclaimer is filed to overcome the double patenting rejection set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, alone or in combination, fails to teach or render obvious (in addition to the other limitations of claims 1 and 12): an outer member; a rotatable shaft positioned for rotational movement within the outer member and fixed axially within the outer member; a non-expandable rotatable tip having a proximal end and a distal end, the distal end having a cross sectional dimension less than a cross-sectional dimension of the proximal end and the proximal end having a uniform cross-sectional dimension, the proximal end of the rotatable tip positioned distally of the distalmost edge of the outer member to create a gap between the proximal end of the rotatable tip and the distalmost edge of the outer member. The closest prior art references include Dillard (US 6,569,177 B1) and Wulfman-843.
Dillard teaches an outer member; a rotatable shaft positioned for rotational movement within the outer member and fixed axially within the outer member; a non-expandable rotatable tip having a proximal end and a distal end, the distal end having a cross sectional dimension less than a cross-sectional dimension of the proximal end, the proximal end of the rotatable tip positioned distally of the distalmost edge of the outer member to create a gap between the proximal end of the rotatable tip and the distalmost edge of the outer member. Dillard fails to teach the proximal end having a uniform cross-sectional dimension. While Wulfman-843 does teach the proximal end having a uniform cross-sectional dimension it would not be obvious to modify Dillard to the proximal end having a uniform cross-sectional dimension because Wulfman-843 provides no motivation for such a modification and the top of Wulfman-843 cannot be substituted with the tip of Dillard as the configuration of the tip is the entire invention of Dillard.
Wulfman-843 teaches an outer member; a rotatable shaft positioned for rotational movement within the outer member; a non-expandable rotatable tip having a proximal end and a distal end, the distal end having a cross sectional dimension less than a cross-sectional dimension of the proximal end and the proximal end having a uniform cross-sectional dimension, the proximal end of the rotatable tip positioned distally of the distalmost edge of the outer member to create a gap between the proximal end of the rotatable tip and the distalmost edge of the outer member. Wulfman-843 is silent regarding the rotational shaft fixed axially within the outer member (Wulfman-843 expressly teaches the opposite). It would not be obvious to modify Wulfman-843 to have the rotational shaft fixed axially within the outer member as it would change the operation of the device of Wulfman-843.
Conclusion
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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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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