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 Interpretation - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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 21-50 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). Laby et al. disclose the invention substantially as claimed. Laby et al. disclose, at least in figures 4A-4D, 5, and 5A and para. [0092]-[0094], [0097], and [0103]-[0108]]; a medical system comprising: a flexible elongate device comprising: a support structure (34) coupled with the flexible body, 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 having at least one stiffening element (36) extending along at least a portion of the flexible body and configured for actuation independent of the support structure, wherein after the flexible body has flexed into the pose, actuation of the at least one stiffening element stiffens the support structure to hold at least a portion of the pose of the flexible body, wherein the at least one stiffening element includes a compression feature (lower portion of 36) configured to engage the support structure; wherein the support structure comprises a coil (42) and the sub-elements include windings of the coil; wherein the support structure comprises a spine (52, as shown in fig. 5A); wherein the stiffening mechanism comprises an inflatable system (combination of 36, 54, 90, and 60; according to para. [0103], and [0104]); wherein the inflatable system comprises a balloon (36) configured to extend in between the sub-elements; wherein 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; wherein 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; wherein the balloon is sleeved over the support structure; wherein 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; wherein 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 activate the stiffening mechanism to hold at least the portion of the pose of the flexible body; wherein 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 the at least one stiffening element, wherein activating the at least one stiffening mechanism comprises operating the pump; wherein the activation of the at least one stiffening element 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; wherein the controller is further configured to activate the at least one stiffening element 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 at least one stiffening element to protect the target area of anatomy (i.e., to produce a desired articulation of the medical system, according to para. [0106]), and wherein the controller is configured to: activate the stiffening mechanism to selectively stiffen the elongate instrument at the region.
However, Laby et al. do not explicitly disclose a flexible body with a proximal end, a distal end, and at least one lumen extending between the proximal and distal ends. Wong teach, at least in figures 1A, 2A, 5-5B, and 7 and col. 6, lines 19-61; col. 8 lines 23-47; col. 9, line 7 to col 10, line 14; col. 14, line 55 to col. 15, line 17; a medical system including a flexible body (e.g., outer portion of 20, as shown in fig. 2A) with a proximal end, a distal end, and at least one lumen extending between the proximal and distal ends. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Wong, to modify the system of Laby et al., so that it includes a flexible body as claimed. Such a modification would allow sheathing and protection of the support structure and the stiffening mechanism.
Laby et al. also do not explicitly disclose that the medical system further comprises a plurality of control elements extending along the flexible body and configured to exert tension on the flexible body to control the pose of the flexible body; wherein the plurality of control elements comprises pull wires, a pull wire, or at least one pull wire extending through the flexible body, wherein manipulation of the at least one pull wire controls a pose of the flexible body, wherein the controller is configured to: (i) selectively control tension applied to the at least one pull wire to control the pose of the flexible body, and (ii) activate the at least one stiffening element based in part on data received from the shape sensor to adjust stiffness of the flexible body. Wong further teaches a plurality of control elements (e.g., 10, according to col. 6, lines 42-49) extending along the flexible body and configured to exert tension on the flexible body to control the pose of the flexible body; wherein the plurality of control elements comprises pull wires (e.g., 10), a pull wire (e.g., 10), or at least one pull wire (e.g., 10) extending through the flexible body, wherein manipulation of the at least one pull wire controls a pose of the flexible body, wherein a controller (according to col. 3, lines 26-67) is configured to: (i) selectively control tension applied to the at least one pull wire to control the pose of the flexible body, and (ii) activate the at least one stiffening element (e.g., coil pip 51, according to col. 9, line 26 to col. 10, line 14; or a pull tube, according to col. 7, line 55 to col. 15, line 8) based in part on data received from a shape sensor (24, according to col. 8 lines 35-47) to adjust stiffness of the 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 medical system of Laby et al., so that it includes, as claimed, control elements or pull wires, a controller, and a shape sensor as taught by Wong. Such modifications would allow the medical system to be steered, bent, or articulated to a desired configuration.
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.
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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Davis et al. (7,914,466) teach a medical system.
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/JULIAN W WOO/Primary Examiner, Art Unit 3771
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