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 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.
Claims 32 is 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. The claim limitation “configured to be movable in a longitudinal direction of the at least one tube” renders this claim indefinite due to, according to the specification and drawings, the device being movable in a direction perpendicular to the longitudinal direction (bending of the steerable instrument) and not in a direction parallel to the longitudinal direction of the tube. The examiner recommends that this claim is amended to remove the indefinite claim language.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 33-39, 42, 44, 45, and 47-48 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Cooper et al (U.S. Patent 11/051,794, hereinafter “Cooper”). Regarding claim 32, Cooper teaches a steerable instrument comprising:
a proximal end and a deflectable distal end (figure 11 both ends of the linkage structure)
and at least one tube (figure 11 element 90) extending in a longitudinal direction, the at least one tube comprising at least one steering strip (figure 11 disks 93-95) which is made from the at least one tube, separated by a slotted structure (gaps between each individual disk 92 and 93 and 95 and 96) from a remainder of the at least one tube, attached to the deflectable distal end and configured to be movable in a longitudinal direction (see 112B rejection above) of the at least one tube such as to deflect the deflectable distal end (each disk moves on the connection to the previous or subsequent disk)
the at least one steering strip having at least one flexible portion located in a flexible zone of the steerable instrument and implemented by a series of adjacent links (steering strip composes adjacent links 93-95 in figure 11 is flexible to allow for deflection)
Regarding claim 33, Cooper teaches a steerable instrument wherein adjacent links are configured to be rotatable in a first plane perpendicular to a radial direction which is defined as a direction perpendicular to a central axis of the steerable instrument (figure 11 below see that disks 96 and 95 rotate in a plane perpendicular to a plane that spans through both hinge connections pointed to with arrows below).
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Regarding claim 34, Cooper teaches a steerable instrument wherein adjacent links are rotatable in a second plane perpendicular to the first plane (figure 11 below see that disks 94 and 95 rotate in a plane perpendicular to a plane that spans through both hinge connections pointed to with arrows below, and that this plane is perpendicular to the one referenced in the last paragraph).
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Regarding claim 35, Cooper teaches a steerable instrument wherein the adjacent links are rotatable, within the first plane, relative to one another to a predetermined maximum angle in which they contact one another and block further rotation in the first plane (figure 11 see that the gaps between adjacent links can be closed when for example, disks 96 and 95 are rotated in relation to each other about their hinge connection that the two surfaces pointed to below are flush with each other).
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Regarding claim 36, Cooper teaches a steerable instrument wherein a bending capacity of the flexible portion of the steering strip is limited by a predetermined amount, and wherein the links are configured to define a maximum bending angle per link length (figure 11 above see that links cannot be bent past a point at which the pointed at surfaces are flush, further movement is prevented by physical interference with the next disk).
Regarding claim 37, Cooper teaches a steerable instrument wherein a first link is provided with an extension extending into an opening of an adjacent second link (figure 13 shows element 100 that fits into gap in element 100 of figure 12).
Regarding claim 38, Cooper teaches a steerable instrument wherein the extension and the opening are shaped such that the extension cannot be retracted from the opening (the fit between elements 100 of both figure 12 and 13 is maintained by “the tension of the actuation cables” as stated in paragraph 10).
Regarding claim 39, Cooper teaches a steerable instrument wherein both the extension and the opening have a circular shape (see elements 100 in figure 12 and 13 are circular in shape).
Regarding claim 42, Cooper teaches a steerable instrument wherein the links are shaped in one of a U-form, V-form, or horseshoe form (see figure 13 angled V-form of element 94).
Regarding claim 44, Cooper teaches a steerable instrument wherein the steerable instrument comprises a further tube inside or outside the at least one tube (paragraph 3 details “cannula sleeves” that surround the tube of the steerable instrument and facilitate entry into the target region of the patient’s body”).
Regarding claim 45, Cooper teaches a steerable instrument wherein the further tube comprises a hinge structure in the flexible zone, and wherein one or more of the links are attached to the hinge structure (figure 11 hinge structure connecting each link to the next).
Regarding claim 47, Cooper teaches a steerable instrument wherein the tube has a thickness in a range of 0.03-2.0 mm (paragraph 74 states outer diameter of disk is about 2 mm).
Regarding claim 48, Cooper teaches a steerable instrument wherein the tube has a diameter in a range of 0.5-20 mm (paragraph 74 states entire diameter of the steerable instrument is 5 mm or less).
Claims 49-51 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Yang et al (U.S. Patent 12,048,819, hereinafter “Yang”). Regarding claim 49, Yang teaches a method of manufacturing a steerable instrument comprising at least one tube extending in a longitudinal direction, the steerable instrument having a proximal end and a deflectable distal end (tube in figure 4a), the method comprising:
providing the at least one tube (figure 4a element 404)
making at least one steering strip (figure 4a final link pointed to with arrow below) from the at least one tube, wherein the steering strip is attached to a distal end of the tube, by forming a slotted structure (figure 4b slotted structure composed of gaps between adjacent links) in a wall of the tube, thereby separating the steering strip from a remainder of the tube (see slotted structure in between each link in figure 4a)
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providing the steering strip with a flexible portion located in a flexible zone of the steerable instrument, wherein the flexible portion is implemented by forming a series of adjacent links in at least a portion of the steering strip (figure 4a see adjacent links 434)
Regarding claim 50, Yang teaches a method wherein the at least one steering strip, including the series of adjacent links, is formed by cutting predetermined patterns in the tube (see figure 6 detailing materials removal technique used on tube).
Regarding claim 51, Yang teaches a method wherein the adjacent links are formed by a materials removal technique applied to the wall of the tube (see figure 6 detailing materials removal technique used on tube).
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.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Cooper in further view of Cooper. Regarding claim 39, Cooper fails to explicitly disclose wherein the slot separating the extension and second link has a width of 0.01 to 2.00 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the slot separating the extension and second link of the steerable instrument of Cooper to have a width of 0.01 to 2.00 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, steerable instrument would not operate differently with the claimed width slot width. Further, Applicant places no criticality on the range claimed, indicating that the slot may be 0.01 to 2.00 mm as a result of the cutting process used to create it, without indicating a structural requirement for this specific range of widths.
Claims 41 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper in view of Cooper et al (U.S. Patent 7,320,700, hereinafter “Cooper 2008”). Regarding claim 41, Cooper teaches the limitations of claim 32, it fails to teach a steerable instrument wherein the extension is an either straight or curved transverse strip. Cooper 2008 teaches a steerable instrument wherein the extension is an either straight or curved transverse strip (figure 2a transverse strips 292). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the steerable instrument of Cooper with the transverse strips of Cooper 2018 in order to “ensure overlap between adjacent layers” as stated in paragraph 79, improving the structural integrity of the steerable instrument as individual links are prevented from separation by the strips catching the next link before separation would occur.
Regarding claim 46, while Cooper teaches the limitations of claims 32, 44, and 45, it fails to teach a steerable instrument wherein the hinge structure comprises a flexible wave form strip for each steering strip. Cooper 2008 teaches a steerable instrument wherein the hinge structure comprises a flexible wave form strip for each steering strip (paragraph 15 details “wave springs” connected in sequence that make up the flexible tube). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the steerable instrument of Cooper with the wave springs of Cooper 2008 in order to increase the range of motion of the steerable instrument, allowing the tube to bend in more planes than the 2 planes of Cooper, allowing the steerable instrument to be used for a wider variety of surgical applications.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Cooper in view of Verbeek (U.S. Patent 8,986,317). While Cooper teaches the limitations of claim 32, it fails to teach a steerable instrument wherein adjacent links are attached to one another by one or more flexible bridges. Verbeek teaches a steerable instrument wherein adjacent links are attached to one another by one or more flexible bridges (claim 11 “adjacent longitudinal elements are interconnected by at least one flexible bridge”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the steerable instrument of Cooper with the flexible bridges of Verbeek in order to improve the cohesion and stability of the steerable instrument, as attaching each link with a flexible bridge still allows maneuverability of the instrument while also maintaining a set distance (defined by the length of each bridge”) between links.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAYTON BARKER whose telephone number is (571)272-0912. The examiner can normally be reached between 9:00 and 5:00 PM EST Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAYTON HYUN JIN BARKER/Patent Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
