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 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 31-47 are rejected under 35 U.S.C. 103 as being unpatentable over Laby et al. (2017/0021132).
Regarding claim 31, Laby et al. disclose, at least in figures 4A-4D, 5, 5A and 12 and para. [0092]-[0094], [0097], and [0103]-[0108]]; a medical system comprising: a flexible elongate device comprising: a support structure (34) coupled with a flexible body (402/404; Figure 12) having a lumen (within 402), the support structure including a plurality of sub-elements (42) arranged in series, wherein at least a portion of the sub-elements are configured to spread apart when the flexible body flexes into a pose; and a stiffening mechanism (36) extending along at least a portion of the flexible body and around the support structure (evident from Figure 12) and configured for actuation independent of the support structure, wherein after the flexible body has flexed into the pose, actuation of the stiffening mechanism stiffens the support structure to hold at least a portion of the pose of the flexible body (the flexible body could be manually flexed into the same pose which the stiffening mechanism would cause, after which actuation of the stiffening mechanism would maintain the pose).
Laby et al. disclose a control element (pullwire - para. [0127]) which would help maintain the pose via tension applied to the flexible body (Applicant’s tension appears to be compression and/or bending applied to the flexible body by the pullwire(s); the pullwire would at least prevent stretching or pulling of the flexible body out of its pose). However, Laby et al. fail to specifically disclose where the control element or pullwire is located and therefore fail to disclose that it is within the support structure. However, official notice is taken that it is well-known in the art to provide a pullwire within a central lumen within an elongate coil or support structure for applying tension to a flexible elongate device (see for example pullwire 150 of US 3,552,384 as evidentiary support). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the control element or pullwire of Laby et al. within the lumen of Figure 12 in order to take advantage of this well known location for positioning a pullwire. With this modification, the stiffening mechanism would be between the support structure and the control element (evident from Figure 12).
Regarding claim 32, Lady et al. disclose that the support structure comprises a coil (42) and the sub-elements include windings of the coil.
Regarding claim 33, Lady et al. disclose that the support structure comprises a spine (52, as shown in fig. 5A).
Regarding claim 34, Lady et al. disclose that the stiffening mechanism comprises an inflatable system (combination of 36, 54, 90, and 60; according to para. [0103], and [0104]).
Regarding claim 35, Lady et al. disclose that the inflatable system comprises a balloon (36) configured to extend in between the sub-elements.
Regarding claim 36, Lady et al. disclose that the stiffening mechanism extends (b) around the support structure (see unlabeled inflatable structures extending around the coil in at least Figure 12), the balloon is configured to extend in between the sub-elements due to application of a vacuum pressure (deflation, according to para. [0108]) causing the balloon to collapse into an exterior of the support structure and in between the sub-elements.
Regarding claim 37, Lady et al. disclose that the stiffening mechanism extends between the support structure and the control element (wherever the pull wire is located, the inflatable stiffening members must extend between it and the coil since they wrap around the coil in Figure 12), and the balloon is configured to extend in between the sub-elements due to application of an inflation pressure causing the balloon to expand into an interior defined within the support structure and in between the sub-elements (the balloon wraps around the sub-elements - Figure 12).
Regarding claim 38, Lady et al. disclose that the balloon is sleeved over the support structure (evident from Figure 12).
Regarding claim 39, Lady et al. disclose that the balloon is one of a plurality of balloons (36), each positioned along a portion of the flexible body, wherein the plurality of balloons are selectively inflatable to hold the at least the portion of the pose of the flexible body.
Regarding claims 40-42, to have provided more than one control element since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. With this medication, the balloon(s) would be sleeved over the control elements as evident from Figure 12.
Regarding claim 43, Lady et al. disclose that the medical system further comprises: a shape sensor (63) for determining the pose of the flexible body, wherein the stiffening mechanism is controlled based on data from the shape sensor; and a controller (60) in communication with the shape sensor, the controller configured to actuate the stiffening mechanism to hold at least the portion of the pose of the flexible body.
Regarding claim 44, Lady et al. disclose that the stiffening mechanism comprises an inflatable system having a pump (a part of 54, according to para. [0104] and [0105]) for applying a vacuum pressure or an inflation pressure to at least one stiffening element of the stiffening mechanism, wherein actuating the stiffening mechanism comprises operating the pump.
Regarding claim 45, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the controller as claimed in order to automate the process of tensioning the control element and actuating the stiffening mechanism.
Regarding claim 46, Lady et al. disclose that actuation of the stiffening mechanism is further based in part on a type of instrument (e.g., a tool according to para. [0082]) received within the lumen of the flexible body.
Regarding claim 47, Lady et al. disclose that the controller is further configured to actuate the stiffening mechanism based in part on anatomical information (from imaging, according to para. [0106] identifying a target area of anatomy), wherein the controller is further configured to actuate the stiffening mechanism to protect the target area of anatomy (i.e., to produce a desired articulation of the medical system, according to para. [0106]),
Claims 48-50 are rejected under 35 U.S.C. 103 as being unpatentable over Laby et al. (2017/0021132) in view of Wong et al. (9,138,166).
Regarding claim 48, Laby et al. do not explicitly disclose that the shape sensor includes a shape sensing fiber extending along the flexible body or a plurality of EM sensors extending along the flexible body. Wong teaches, in col. 8, lines 35-47, a shape sensing fiber (24) extending along a flexible body. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the shape sensor of Laby et al., so that it is a shape sensing fiber extending along the flexible body. Such a modification would allow the shape of the flexible body to be accurately determined before and during movement of the flexible body through a patient’s body.
Regarding claim 49, Laby et al. also do not explicitly disclose that the controller is configured to: determine whether data from the shape sensor exceeds a predetermined threshold for identifying application of an external force to the flexible body; and identify a region of the flexible body associated with the data that exceeds the predetermined threshold; and wherein the controller is configured to: activate the stiffening mechanism to selectively stiffen the flexible body at the region. Wong teaches a controller (according to col. 3, line 65 to col. 4, line 23) that is configured to: determine whether data from a shape sensor (a shape sensing fiber) exceeds a predetermined threshold (as determined from registered coordinate systems of the shape sensing fiber and an elongate instrument) for identifying application of an external force to the elongate instrument (that had shaped the elongate instrument); and identify a region of the elongate instrument (at a distal portion) associated with the data that exceeds the predetermined threshold. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the controller of Laby et al., so that the controller that is configured to determine whether data from a shape sensor exceeds a predetermined threshold for identifying application of an external force to the flexible body; and identify a region of the flexible body associated with the data that exceeds the predetermined threshold. Such a modification would allow determination of the precise shape of the flexible body to be applied within a patient’s body.
Regarding claim 50, Lady et al. disclose that the controller is configured to: actuate the stiffening mechanism to selectively stiffen the elongate instrument at the region.
Response to Arguments
Applicant's arguments filed February 13th 2026 have been fully considered but they are not persuasive. Applicant has argued that actuation of the balloons of Laby et al. causes the articulation and does not maintain an already set articulated state. The flexible body of Laby et al. could be manually flexed into the same pose which the stiffening mechanism would cause (for example if forced through a lumen having this shape), after which actuation of the stiffening mechanism would maintain the pose. Applicant has argued that actuating the balloons would not stiffen the support structure but rather would maintain its current stiffness. Actuation of the balloons would stiffen the coil in the region of the balloons against deformation by a direct force to this region. Applicant’s arguments regarding the pullwires of Wong et al. are moot in view of the current grounds of rejection.
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.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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