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.
Claim(s) 22-26, 28-35, 37-38, and 41-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon (US 5,643,248) in view of Hulvershorn et al. (US 2011/0046477).
Regarding claim 22, Yoon discloses a system for providing access to an anatomical target via a body lumen, comprising: a handle (e.g., handle 11) coupled with a proximal shaft (19) via an interface (depicted in Figure 3 and which includes elements such as tubular member 14, biasing members 16 and 66, as well as trigger 90), wherein the interface is configured to maintain the positional relationship between the handle and the proximal shaft while a force less than a threshold force is transmitted to the proximal shaft and to allow the handle to move with respect to the proximal shaft when a force greater than the threshold force is transmitted to the proximal shaft (see Col. 7, lines 4-18 which disclose that when an instrument is connected to second end 50, it will allow for movement against the biasing member into the housing until a certain force causes the locking of the shaft in a proximal location to avoid excessive force being applied to the tissue; see also Col. 4, line 41-Col. 5, line 14 for the general structure; as long as the spring force of spring 66 is greater than the force being applied to the tip of the shaft, there will be no movement of the shaft relative to the handle). Yoon further discloses that the device is to be used with multiple new probes for reducing costs and simplifying sterilization (Col. 8, lines 45-57), but fails to explicitly disclose a set of removable shafts with the handle as part of a kit, each removable shaft configured to be coupled with the proximal shaft and configured to transmit force to the proximal shaft.
Hulvershorn et al. (henceforth Hulvershorn) teaches a medical kit which comprises a plurality of shafts as part of the kit (¶ [0086] discloses a kit comprises replacement parts such as needles or catheters).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Yoon to be formed as a kit with multiple replacement shafts so as to allow for multiple uses of the handle device with multiple replacement components. Yoon, as above, teaches that it is desirable to provide for multiple shafts or instruments to be coupled to the handle to reduce costs and sterilization requirements, and Hulvershorn teaches that it is known to provide multiple components such as shafts in a kit assembly which would achieve the desired end goal of the device of Yoon.
Regarding claim 23, Yoon further discloses the use of the device with a variety of instruments or shafts to be connected to the handle (this would anticipate the varying size requirement of claim 23). In the cited combination, any of these instruments or differently sized shafts (cutters, needles, cannulae, catheters, or other options are set forth). Therefore, it would have been obvious to provide the kit of Yoon/Hulvershorn with differently sized shafts depending on the types of procedures the user might perform and what would be required.
Regarding claims 24 and 25, Yoon further discloses wherein the interface comprises a mechanical feature that allows the handle to move with respect to the proximal shaft when the removable shaft experiences a force greater than the threshold force (as above, the interface is mechanical in that it utilizes springs 16 and 66 to allow for the tubular member 14 to transition within the handle and absorb force which would be applied to the tissue; Col. 7, lines 5-18; this is also a feature as per claim 25 as the spring force provides for the relative movement; the components move within the handle, but the handle may be considered to move relative to the shaft depending on perspective).
Regarding claim 26, Yoon further discloses wherein the interface comprises a feature or set of features on the proximal shaft that allows the handle to move with respect to the proximal shaft when the removable shaft experiences a force greater than the threshold force (the attachment thread 56 for coupling the shaft to the handle may be considered part of the interface as it provides the connection means for coupling the shaft to the movable handle components; Col. 4, lines 30-40).
Regarding claims 28 and 41, Yoon further discloses wherein the interface comprises a shaft coupling element (56 on 14), a handle coupling element (inside of 11 comprising 14, 16, and 66), and a bistable element connecting the shaft coupling element to the handle coupling element, wherein the bistable element is configured to transition from a first stable configuration (Figure 3; e.g., when tubular member 14 is experiencing a force less than the spring force) to a second stable configuration (Figure 5) when the removable shaft experiences a force greater than the threshold force (Col. 6, lines 51-64; the shaft will move until tubular member abuts trigger 90 which releases spring 66; the spring of the connection is considered bistable since the interface has a first state which constrains all of the internal expansion components, such as the spring 66, until a force is applied which releases the interface into a second state which is different and expanded from the first state; the claim does not require the bistable element to be formed from a specific material or change shape in a specific manner; bistable is being interpreted here as providing for two distinct states such as in Figures 3 and 5 of Yoon wherein there are discrete locked and unlocked movement states based upon the force applied to the shaft).
Regarding claims 29 and 42, Yoon further discloses wherein the interface comprises a shaft coupling element (56 on 14), a handle coupling element (portion of 14 receiving spring 66; Figure 4) and a buckling element (spring 66) connecting the shaft coupling element to the handle coupling element (spring 66 is constrained by 46 on element 14 to which the shaft is attached), wherein the buckling element is characterized by a stiffness (spring rate) that resists buckling until the removable shaft experiences a force greater than the threshold force (Col. 6, lines 51-64; the shaft will move until tubular member abuts trigger 90 which releases spring 66; the spring of the connection is considered a buckling element since the interface has a first state which constrains all of the internal expansion components, such as the spring 66, until a force is applied which releases the interface into a second state which is different and expanded from the first state).
Regarding claims 30 and 43, Yoon further discloses wherein the handle comprises an upper handle portion and a lower handle portion coupled to the proximal shaft, wherein the interface comprises an interlocking element (e.g., trigger 90) positioned between the upper and lower handle portions (it can be seen in Figures 3-5 that the trigger is located at the midpoint of the handle and provides a means of locking the travel of tubular element 14 until a specific force is reached, at which point it will rotate and release the tubular member via expansion of springs 16 and 66; Col. 6, lines 51-64).
Regarding claim 31, Yoon further discloses visual feedback to a user when the removable shaft experiences a force greater than the threshold force (see e.g., knob 36 in Figure 3 abuts a distal end of the housing in slot 24; after the force has been overcome the device moves into the configuration of Figure 5 wherein the knob is at the proximal end of the slot which will provide a visual indication to the user that a force greater than the desired force has been applied).
Regarding claim 32, Yoon discloses A system for providing access to an anatomical target via a body lumen, comprising: a handle coupled with a proximal shaft via an interface, wherein the interface is configured to provide tactile feedback, audible feedback, visual feedback, or combinations thereof to a user when the shaft experiences a force greater than a threshold force; and a set of removable shafts, each removable shaft configured to be coupled with the proximal shaft and configured to transmit force to the proximal shaft (Yoon discloses removable probes as part of the system for performing different functions). Yoon further discloses that the device is to be used with multiple new probes for reducing costs and simplifying sterilization (Col. 8, lines 45-57), but fails to explicitly disclose a set of removable shafts with the handle as part of a delivered kit, each removable shaft configured to be coupled with the proximal shaft and configured to transmit force to the proximal shaft.
Hulvershorn et al. (henceforth Hulvershorn) teaches a medical kit which comprises a plurality of shafts as part of the kit (¶ [0086] discloses a kit comprises replacement parts such as needles or catheters).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Yoon to be formed as a kit with multiple replacement shafts so as to allow for multiple uses of the handle device with multiple replacement components. Yoon, as above, teaches that it is desirable to provide for multiple shafts or instruments to be coupled to the handle to reduce costs and sterilization requirements, and Hulvershorn teaches that it is known to provide multiple components such as shafts in a kit assembly which would achieve the desired end goal of the device of Yoon. In such a combination, the shafts which have different uses, would meet the varying size requirements of the claim).
Regarding claims 33-35, Yoon further discloses wherein the interface comprises a mechanical feature that allows the handle to move with respect to the proximal shaft when the removable shaft experiences a force greater than the threshold force (as above, the interface is mechanical in that it utilizes springs 16 and 66 to allow for the tubular member 14 to transition within the handle and absorb force which would be applied to the tissue; Col. 7, lines 5-18; this is also a feature as per claim 34 as the spring force provides for the force prevention via the resistance of the spring rate as the force is applied as long as it’s below a desired threshold; the components move within the handle, but the handle may be considered to move relative to the shaft depending on perspective; this is specifically disclosed as to prevent tissue damage from excessive force as per claim 35; Col. 8, lines 33-38).
Regarding claim 37, Yoon further discloses wherein the interface comprises a mechanical feature that is configured to prevent excess force on the body lumen when the removable shaft experiences a force greater than the threshold force (as above, the interface is mechanical in that it utilizes springs 16 and 66 to allow for the tubular member 14 to transition within the handle and absorb force which would be applied to the tissue; Col. 7, lines 5-18 and Col. 8, lines 33-38 disclose preventing excess force on anatomical tissue).
Regarding claim 38, Yoon further discloses wherein the interface comprises a feature or set of features on the proximal shaft or handle that prevents excess force on a body lumen when the shaft experiences a force greater than the threshold force (the attachment thread 56 for coupling the shaft to the handle may be considered part of the interface as it provides the connection means for coupling the shaft to the movable handle components; Col. 4, lines 30-40; the components of the handle work to prevent excessive force as claimed; see also Col. 8, lines 33-38).
Claim(s) 22, 27, 32, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenblat (WO 2016125176) in view of Hulvershorn et al. (US 2011/0046477).
Regarding claims 22 and 32, Rosenblat discloses a system for providing access to an anatomical target via a body lumen, comprising: a handle (e.g., handle 130; Figure 10C) coupled with a proximal shaft (110) via an interface (depicted in Figure 10C; ¶¶ [0174]-[0176]), wherein the interface (e.g., interaction between 121 and 131) is configured to maintain the positional relationship between the handle and the proximal shaft while a force less than a threshold force is transmitted to the proximal shaft (¶ [0175] while the force applied on the limiter via the shaft is less than the predetermined Fmax) and to allow the handle to move with respect to the proximal shaft when a force greater than the threshold force is transmitted to the proximal shaft (Figure 10D, the force has overcome the maximum required to maintain stopping element 121 in a position distal to holding element 131); wherein the interface is configured to provide visual feedback when the shaft experiences a force greater than a threshold force (as applied to claim 32; see Figures 10C-10D, after the threshold force is overcome, the element 124 extends out of the proximal end of the handle; see also ¶ [0015] which discloses the use of various feedback alerts for the user based on the applied force). Rosenblat fails to explicitly disclose a set of removable shafts with the handle as part of a kit, each removable shaft configured to be coupled with the proximal shaft and configured to transmit force to the proximal shaft. Though it is noted that Rosenblat contemplates use of the device with various shaft type elements (see e.g., ¶ [0114] which discloses various instruments which might be used with the handle/shaft system).
Hulvershorn et al. (henceforth Hulvershorn) teaches a medical kit which comprises a plurality of shafts as part of the kit (¶ [0086] discloses a kit comprises replacement parts such as needles or catheters).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Rosenblat to be formed as a kit with multiple replacement shafts so as to allow for multiple uses of the handle device with multiple replacement components. Hulvershorn teaches that it is known to provide multiple components such as shafts in a kit assembly for a medical device which can be readily connected to other components for performing a procedure. Since Rosenblat discloses the use of multiple shaft types for use with the handle, it would have been obvious to one of ordinary skill in the art to provide a kit with multiple tools or multiple sets of shafts for performing different procedures as known from Rosenblat (and as applied to claim 32).
Regarding claims 27 and 40, Rosenblat further discloses a medical device for limiting tissue damage which comprises a set of projections (131; Figure 10C) on a handle (130) and a detent (121) or set of detents on a proximal shaft (110; ¶ [0176] discloses how the limiter in the handle and shaft function to achieve the desired force threshold).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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