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 Objections
Claim 1 is objected to because of the following informalities: line 8 should read “…at least…”. Appropriate correction is required.
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.
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 10-22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2002/0138091 to Pflueger in view of U.S. Patent Publication 2012/0277730 to Salahieh or WO 2016/007652 to Patel.
As to claim 10, Pflueger discloses a device capable of being an occlusion crossing device (paragraph 14,15), comprising: an outer shaft (40a, figure 5) defining a lumen (figure 5) and a distal opening (42a) that is angled relative to a central axis of the outer shaft to form a distal-most tip (figure 1), wherein the distal opening is circumferentially beveled inward from an outer surface of the outer shaft (figure 5, the distal opening has a bevel along at least a portion of a circumference that can have an inward angle), further wherein a distal portion of the outer shaft includes a backbone that extends longitudinally along at least a portion of the outer shaft (paragraph 26, 55, 59, the cannula can be manually structured to be deformable, the structure to be deformable can be the backbone); an inner shaft (34a) extending within the lumen and configured to rotate with respect to the outer shaft (paragraph 60), the inner shaft including a distal end having a drill tip (56a) that is configured to extend through the distal opening (figure 5, paragraph 56, 52), however is silent about the backbone is configured to bias lateral bending of the distal portion.
Salahieh teaches a similar device (steerable device, abstract) having a backbone (12, paragraph 67, 69) configured to bias lateral bending of a distal portion of a cannula for the purpose of steering a device to a target location. Patel also teaches a similar device (occlusion crossing device, abstract) having a backbone (245, paragraph 31, 33) configured to bias lateral bending of a distal portion of a cannula for the purpose of providing added flexibility during bending. The outer shaft of Pflueger can have a backbone which can bias lateral bending of the distal portion of the cannula, as taught by Salahieh and/or Patel, to help steer the drill tip to the target location. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the device of Pflueger have a backbone configured to bias lateral bending of the distal portion in order to be able to steer the device to a target location.
As to claim 11, with the device of Pflueger and Salahieh/Patel above, Patel further teaches an imagining element (119/199/144, paragraph 36) coupled to an inner shaft and configured to rotate with the inner shaft for the purpose of providing imaging capabilities to the user. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the imagining element of Patel in the inner shaft of Pflueger in order to providing imaging capabilities to the user.
As to claim 12, with the device of Pflueger and Salahieh/Patel above, Patel further teaches the imagining element comprises an optical coherence tomography (OCT) imaging window (paragraph 36).
As to claim 13, with the device of Pflueger and Salahieh/Patel above, Pflueger discloses the distal-most tip is configured to pass in front of the imaging element (of Patel) as the imaging element rotates, forming a registration mark. The inner shaft of Pflueger can rotate (paragraph 51) and be advanced/withdrawn (paragraph 58). Therefore the inner shaft can be positioned such that the imagine element (of Patel) can pass in front of the distal most tip, which can form a registration mark.
As to claim 14, with the device of Pflueger and Salahieh/Patel above, Patel further teaches the imaging element comprises an optical fiber (119) paragraph that extends within the inner shaft and substantially along a central axis of the inner shaft (figure 1d).
As to claim 15, with the device of Pflueger and Salahieh/Patel above, Pflueger discloses a handle (14) attached to the inner shaft and the outer shaft and configured rotate the inner shaft.
As to claim 16, with the device of Pflueger and Salahieh/Patel above, Pflueger discloses handle is configured to rotate the drill tip at speeds of greater than 500 rpm (paragraph 52).
As to claim 17, with the device of Pflueger and Salahieh/Patel above, Salahieh further teaches the backbone is part of a selective bending support of the outer shaft, the selective bending support at least partially surrounding a flexible tube of the outer shaft (16/505/170, paragraph 68, 69, 70, 87, 96, 97, 136). Salahieh teaches the steerable portion of the cannula can have multiple different tubes/shafts. The different tubes/shafts can read on the selective bending support surrounding a flexible tube.
As to claim 18, with the device of Pflueger and Salahieh/Patel above, Salahieh further teaches the flexible tube comprises a braided material (paragraph 87, 96, 97).
As to claim 19, with the device of Pflueger and Salahieh/Patel above, Salahieh further teaches the braided material is made of a metal material that is surrounded by a polymeric laminate material (paragraph 87, 96, 97, 102, 136). Salahieh teaches the device can have different layers, where the device, or portions of the device can comprise a metal material, and have polymeric laminate material. If it would not be known that the device can have the braided material made of a metal material that is surrounded by a polymeric laminate material, it would have been obvious since it has been held to be within the general skill of an ordinary in the art to select a known material on the basis of its suitability for the intended use.
As to claim 20, with the device of Pflueger and Salahieh/Patel above, Salahieh further teaches the outer shaft includes circumferential cuts that extend at least partially through a thickness of the outer shaft, wherein the backbone is between the circumferential cuts (figure 2a-c, 3-10).
As to claim 21, with the device of Pflueger and Salahieh/Patel above, Salahieh further teaches the outer shaft includes multiple backbones (figure 2a-c, 3-10). Patel also teaches the multiple backbones, figure 1a.
As to claim 22, with the device of Pflueger and Salahieh/Patel above, Pflueger discloses the inner shaft is removably coupled with the outer shaft (paragraph 59, the inner shaft can be withdrawn through the outer shaft).
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 1-7, 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-16 of U.S. Patent No. 12,167,867. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims an occlusion crossing device (claim 1), comprising: an outer shaft (claim 1) defining a lumen (claim 1), wherein the outer shaft includes a distal opening (claim 1) that is angled relative to a central axis of the outer shaft to form a tapered distal end (claim 1); and an inner shaft (claim 1) configured to translate within the outer shaft and to rotate with respect to the outer shaft (claim 1), the inner shaft including: a distal end having cutting edges (claim 1); and an imaging window (claim 1) on a lateral side of the inner shaft proximal to the cutting edges, wherein when at last a portion of the cutting edges are fully extended distally through the distal opening of the outer shaft, the tapered distal end of the outer shaft is arranged to occlude the imaging window at a defined rotational position as the inner shaft is rotated relative to the outer shaft to provide a registration mark for imaging (claim 1).
As to the instant application’s claim 2, see reference patent claim 4.
As to the instant application’s claim 3, see reference patent claim 12.
As to the instant application’s claim 4, see reference patent claim 2.
As to the instant application’s claim 5, see reference patent claim 2.
As to the instant application’s claim 6, see reference patent claim 3.
As to the instant application’s claim 7, see reference patent claim 6.
As to the instant application’s claim 10, the reference patent claims an occlusion crossing device (claim 13), comprising: an outer shaft defining a lumen (claim 13) and a distal opening (claim 13) that is angled relative to a central axis of the outer shaft to form a distal-most tip (claim 13), wherein the distal opening is circumferentially beveled inward from an outer surface of the outer shaft (claim 14), further wherein a distal portion of the outer shaft includes a backbone that extends longitudinally along at least a portion of the outer shaft (claim 13), wherein the backbone is configured to bias lateral bending of the distal portion (claim 13); an inner shaft (claim 13) extending within the lumen and configured to rotate with respect to the outer shaft (claim 13), the inner shaft including a distal end having a drill tip that is configured to extend through the distal opening (claim 13).
As to the instant application’s claim 11, see reference patent claim 13
As to the instant application’s claim 12, see reference patent claim 13.
As to the instant application’s claim 13, see reference patent claim 13.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,167,867 in view of U.S. Patent Publication 2015/0272615 to Newhauser.
As to claim 8, the reference patent claims the device above but is silent about the cutting edges of the distal end of the inner shaft include a first region having a first diameter, and a second region distal to the first region, wherein the second region has a second diameter that is less than 60% of the first diameter.
Newhauser teaches a similar device (occlusion crossing device) comprising cutting edges of the distal end of the inner shaft include a first region having a first diameter, and a second region distal to the first region, wherein the second region has a second diameter that is less than 60% of the first diameter (paragraph 134) in order to facilitate advancement of the device. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the cutting edges of the distal end of the inner shaft include a first region having a first diameter, and a second region distal to the first region, wherein the second region has a second diameter that is less than 60% of the first diameter in order to facilitate advancement of the device.
Claim 9, 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-16 of U.S. Patent No. 12,167,867 in view U.S. Patent Publication 2012/0277730 to Salahieh.
As to claim 9, the reference patent claims the device above including a backbone configured to bias lateral bending of the distal end of the outer shaft (claim 2) but is silent about a flexible tube, a selective bending support that at least portions surround a distal end of the tube, the selective bending support including the backbone, that extends longitudinally along a portion of the flexible tube.
Salahieh teaches a similar device (steering device abstract) a flexible tube (16/505/170), a selective bending support that at least portions surround a distal end of the tube, the selective bending support including a backbone, that extends longitudinally along a portion of the flexible tube (paragraph 68, 69, 70, 87, 96, 97, 136) in order for providing added flexibility during bending. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the reference patent have the backbone be a part of a selective bending support that extends longitudinal along apportion of the flexible tube in order for providing added flexibility during bending
As to claim 17, the reference patent claims the device above but is silent about the backbone is part of a selective bending support of the outer shaft, the selective bending support at least partially surrounding a flexible tube of the outer shaft.
Salahieh teaches a similar device (steering device abstract) having a backbone be part of a selective bending support of the outer shaft, the selective bending support at least partially surrounding a flexible tube of the outer shaft (16/505/170, paragraph 68, 69, 70, 87, 96, 97, 136) providing added flexibility during bending. Salahieh teaches the steerable portion of the cannula can have multiple different tubes/shafts. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the reference patent have the backbone be a part of a selective bending support at least partially surrounding a flexible tube of the outer shaft in order for providing added flexibility during bending
As to claim 18, Salahieh further teaches the flexible tube comprises a braided material (paragraph 87, 96, 97).
As to claim 19, Salahieh further teaches the braided material is made of a metal material that is surrounded by a polymeric laminate material (paragraph 87, 96, 97, 102, 136). Salahieh teaches the device can have different layers, where the device, or portions of the device can comprise a metal material, and have polymeric laminate material. If it would not be known that the device can have the braided material is made of a metal material that is surrounded by a polymeric laminate material it would have been obvious since it has been held to be within the general skill of an ordinary in the art to select a known material on the basis of its suitability for the intended use.
Claim 14-16, 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-16 of U.S. Patent No. 12,167,867 in view of WO 2016/007652 to Patel.
As to claim 14, the reference patent claims the device above but is silent about the optical fiber extends within the inner shaft substantially along a central axis of the inner shaft.
Patel teaches a similar device (occlusion crossing device) where an optical fiber extends within the inner shaft substantially along a central axis of the inner shaft (paragraph 26) for the purpose of decreasing the profile of the device and allowing rotation at high speeds. It would have been obvious to one of ordinary skill in the art before the effective filing date have the optical fiber of the reference patent extend along a central axis of the inner shaft in order for decreasing the profile of the device and allowing rotation at high speeds.
As to claims 15, 16, the reference patent claims the device above but is silent about the handle attached to the inner shaft and the outer and configured to rotate the inner shaft and drill tip at speeds of greater than 500 rpm.
Patel teaches a similar device (occlusion crossing device) having a handle attached to an inner shaft and an outer and configured to rotate the inner shaft and drill tip at speeds of greater than 500 rpm (paragraph 10, 11) for the purpose of actuating the drill tip. It would have been obvious to one of ordinary skill in the art before the effective filing date have the device comprise a handle attached to an inner shaft and an outer and configured to rotate the inner shaft and drill tip at speeds of greater than 500 rpm in order for actuating the drill tip.
As to claims 20, 21, the reference patent claims the device above but is silent about the outer shaft includes circumferential cuts that extend at least partially through the a thickness of the outer shaft, wherein the backbone is between the circumferential cuts, or the outer shaft includes multiple backbones.
Patel teaches a similar device (occlusion crossing device) where the outer shaft includes circumferential cuts that extend at least partially through the a thickness of the outer shaft (paragraph 31, 33, 34, wherein the backbone is between the circumferential cuts, or the outer shaft includes multiple backbones (paragraph 26) for the purpose of adding increase flexibility to the device. It would have been obvious to one of ordinary skill in the art before the effective filing date for the reference patent to have the circumferential cuts and/or multiple backbones in the reference patent in order for increased flexibility to the device.
As to claims 22, the reference patent claims the device above but is silent about the inner shaft is removably coupled with the outer shaft.
Patel teaches a similar device (occlusion crossing device) where the inner shaft is removably coupled with the outer shaft (paragraph 9, 11, 46) for the purpose allowing the outer shaft to be used for other purposes. It would have been obvious to one of ordinary skill in the art before the effective filing date for the reference patent to have the inner shaft be removably coupled with the outer shaft in order to allow the outer shaft to be used for other purposes.
Conclusion
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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