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 .
Terminal Disclaimer
The terminal disclaimer filed on 08/04/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent 12,167,867 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant argues in the response filed 08/04/2026 that Pflueger does not disclose the circumferentially bevel, and that neither Salahieh nor Patel would teach how the added spine or backbone would be circumferentially indexed relative to the distal-most tip. However it is to be noted the specific bevel does not have any further limitations with respect to it has to be the entire circumference that will define the distal most tip and/or the specific angle that creates the inward bevel. Pflueger does disclose a bevel around the edge of the distal-most tip which can be interpreted to be inward since it is slanted inward at least a portion of the bevel. The bevel will be around at least a portion of the circumference which can read on the claim limitation. Further, the claim is a device claim so cannot positively recite any method steps. Both Salahieh and Patel does teach the backbone that will have the bending plane relative to the distal-most tip. Further Patel can teach the first and second engagement region limitations as argued below. The rejection with respect to Pflueger as modified by Salahieh and Patel has been maintained below.
The terminal disclaimer filed overcomes the double patenting rejection. The double patenting rejections is withdrawn.
The examiner agrees with the applicant arguments that the prior art would not be able to read on the amended claim 13. Claim 13 is objected below for being an allowable claim dependent on a rejected claim. Incorporating claim 13 into claim 10 would place the application in condition for allowance.
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 10-12, 14-22 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 in a plane that includes a midline of the central axis the distal-most tip and in a direction fixed relative to the distal-most tip, the outer shaft further including a first engagement region, a second engagement region on an outer surface of the inner shaft configured to engagement the outer shaft, wherein distal driving of the second engagement region against the first engagement bends the distal portion laterally away from the distal-most tip.
Salahieh teaches a similar device (steerable device, abstract) having a backbone (12, paragraph 67, 69, figure 2a-c) configured to bias lateral bending of a distal portion of a cannula in a plane that includes a midline of a central axis a distal-most tip and in a direction fixed relative to a distal-most tip 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, figure 1a,b) configured to bias lateral bending of a distal portion of a cannula in a plane that includes a midline of the central axis the distal-most tip and in a direction fixed relative to the distal-most tip for the purpose of providing added flexibility during bending. Patel also teaches outer shaft further including a first engagement region (where 124 is located, figure 1d, paragraph 28), a second engagement region on an outer surface of the inner shaft configured to engagement the outer shaft (paragraph 28, 30), wherein distal driving of the second engagement region against the first engagement bends the distal portion laterally away from the distal-most tip (paragraph 28, 30, 33) for the purpose of helping to maneuver the distal end of the device. The outer shaft of Pflueger can have a backbone and the first and second engagement regions which can bias lateral bending of the distal portion of the cannula, as taught by Salahieh and 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 a plane that includes a midline of the central axis the distal-most tip and in a direction fixed relative to the distal-most tip in order for providing added flexibility during bending. It also would have been obvious to one of ordinary skill in the art before the effective filing date in the device of Pflueger, the outer shaft of Pflueger include a first engagement region, a second engagement region on an outer surface of the inner shaft configured to engagement the outer shaft, wherein distal driving of the second engagement region against the first engagement bends the distal portion laterally away from the distal-most tip in order to be able to help 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 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).
Allowable Subject Matter
Claims 1-9 are allowed.
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Of note: A call was made to the applicant for an examiner’s amendment but the applicant was not able to be reached for an agreement on the allowable subject matter in the allotted time.
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
