Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to claim amendments
Claim amendments dated 2/27/26 overcome the previous claim objections and 112(b) rejections.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-26, 28-35 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barbagli et al. [US 2009/0012533 A1, hereinafter “Barbagli”] in view of Schneider [US 2006/0146010 A1].
Re. claim 21, Barbagli discloses: a workstation [320, Fig. 3] configured for operating a robotic catheter system [Par. 0003], the workstation comprising:
a user interface [Fig. 5] configured to receive a first user input [input from Master Input Device (MID) 324, Par. 0063], the first user input corresponding to a predetermined movement profile [“a computer…may be activated to automatically position a catheter instrument…inside a patient,” Par. 0063. Thus, the path that the catheter follows is the predetermined movement profile which is activated by the user using the interface, The MID causes the catheter to be inserted and controlled, Par. 0062]; and
a control system [602] operatively coupled to the user interface [Fig. 6, Par. 0065], the control system configured to
remotely control movement of at least a first percutaneous device [guide catheter 302 and working instrument/tool 130] in an axial direction along a longitudinal axis of the first percutaneous device and for rotation about the longitudinal axis of the first percutaneous device [“carriages…are driven forwards and backwards,” and “components…may also be rotated about a shaft to impart rotational motion to the guide catheter,” Par. 0068], and
control movement of the first percutaneous device according to the predetermined movement profile [Pars 0062, 0063 and 0068].
Barbagli is silent regarding the predetermined movement profile including a series of pulsed axial steps. However, Schneider teaches, in a robotic catheter system [Par. 0059],
the predetermined movement profile including a series of pulsed axial steps [“In addition to continuous movement, mode of operation can be included to individually step or "bump" the controlled device or devices in movements of very fine resolution or granularity. This may be done in a rapid "hammering" fashion, or slowly and gently, in accordance with the needs for member advancement or retraction,” Par. 0066]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Barbagli by configuring the control system to control movement in a series of pulsed axial steps, as taught by Schneider, because this allows the operator to “achieve greater control than he or she would have while using traditional manipulation techniques,” [Schneider Par. 0066].
The limitation “for advancing the first percutaneous device along the longitudinal axis while rotating the first percutaneous device” is the intended use or result of the above device. Given the teachings of combined Barbagli-Schneider, one or ordinary skill would reasonably have been apprised of the benefits of advancing the device while rotating as claimed.
Re. claim 22, the modified Barbagli discloses the predetermined movement profile further comprises a rotation rate [because the controller causes the first percutaneous device to rotate, as in Par. 0068, it necessarily includes the rotation rate, whether or not this rate can be changed].
Re. claim 23, Barbagli further discloses the user interface is configured to receive a second user input [input received from data gloves 325, Par. 0063] defining a movement parameter of the predetermined movement profile [Par. 0063].
Re. claim 24, Barbagli is silent regarding the movement parameter being one of the claimed parameters. However, Schneider teaches wherein the movement parameter is at least one of a step distance, a step duration, a rest duration, or a rotation rate [a step duration and/or a rest duration. Par. 0066 describes the controlled rate of stepping]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Barbagli by configuring the movement parameter to include a step or rest duration as taught by Schneider in order to meet the needs for member advancement or retraction [Schneider Par. 0066].
Re. claim 25, Barbagli further discloses the user interface is configured to receive a second user input [input received from console 323] different from the first user input [from 324], the control system configured to activate one or more of a first set of instructions [the instructions for controlling working instrument 130, including adjustment 116] and a second set of instructions [the instructions for controlling guide catheter 302] based on the second user input [“By manipulating the console 323…an operator can cause an instrument driver…to remotely control…instruments…302…and…130,” Par. 0062], and control the first percutaneous device based upon both the first user input and one or more activated sets of instructions [“In response to the processed inputs, and in accordance with the adjusted control model 116, the master computer 602 processes instructions to instrument driver computer…to activate the appropriate mechanical response from the associated motors and mechanical components,” Par. 0066].
Re. claim 26, Barbagli further discloses the user interface further comprises:
a first control [324] configured to receive the first user input; a second control [323] associated with the first set of instructions [Par. 0062], the second control configured to receive the second user input; and
a third control [325] associated with the second set of instructions [Par. 0065], the second control configured to receive a third user input [the input received via gloves 325], wherein the control system is configured to activate the first set of instructions in response to the second user input [Par. 0062, control of 130] and to activate the second set of instructions in response to the third user input [Par. 0062-63, control of 302].
Re. claim 28, Barbagli further discloses both the first set of instructions and the second set of instructions are activated at the same time and the control system is configured to control the first percutaneous device based upon the first user input, the activated first set of instructions and the activated second set of instructions [302 is controlled according to its instructions, and 130 according to its instructions, at the same time, at least via first input Par. 0063].
Re. claim 29, Barbagli further discloses the first set of instructions is activated in response to the second user input [Par. 0062, control of 130],
and the control system is configured to automatically activate the second set of instructions based upon data received by the control system [Par. 0063].
Re. claim 30, Barbagli further discloses the second set of instructions is associated with a feature of the first percutaneous device and the received data is indicative of the feature of the first percutaneous device [Par. 0055].
Re. claim 31, Barbagli further discloses the feature of the first percutaneous device is at least one of a type, a make, a model, or a physical characteristic of the first percutaneous device [Par. 0055-0056].
Re. claim 32, Barbagli further discloses the data is received from an RFID tag associated with the first percutaneous device [Par. 0053].
Re. claim 33, Barbagli further discloses the predetermined movement profile is based upon a type of the first percutaneous device [Pars. 0055-0057].
Re. claim 34, Barbagli further discloses the predetermined movement profile is based upon a type of disease to be treated [indirectly, because the type of disease to be treated affects the type/size/structure of the percutaneous device. See Par. 0054].
Re. claim 35, Barbagli further discloses the predetermined movement profile corresponds to a type of procedure to be performed [indirectly, because the type of procedure to be performed affects the type/size/structure of the percutaneous device. See Par. 0054].
Claim 27 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barbagli in view of Schneider, as applied to claim 21, and further in view of Garibaldi et al. [US 20080055239 A1, hereinafter “Garibaldi”]
Re. claim 27, Barbagli discloses the apparatus as set forth above wherein the first control comprises a joystick [324, Fig. 5]. Barbagli discloses a touch screen [322] but fails to explicitly disclose the second control comprises a first touch screen icon, and the third control comprises a second touch screen icon.
However, Garibaldi teaches, in a workstation for operating a medical system, the second control comprises a first touch screen icon, and the third control comprises a second touch screen icon [Fig. 3, 112 and 114]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Barbagli by configuring the second control to comprise a first touch screen icon, and the third control to comprise a second touch screen icon, as taught by Garibaldi, because this amounts to a simple substitution of one type of input device known in the art for another with predictable results.
Claim 36-38 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barbagli in view of Schneider, as applied to claim 21, and further in view of Verard et al. [US 20040097805 A1, hereinafter “Verard”].
Re. claim 36, Barbagli discloses the apparatus as set forth above but fails to teach the system configured to determine whether the device will advance into a side branch. However, Verard teaches, in a workstation for operating a robotic catheter system, the control system is configured to determine whether the first percutaneous device will advance into a side branch [“Projected trajectories of the forward advance of the catheter 306 can also be tracked and superimposed on the image 318,” Par. 0144]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Barbagli to determine whether the device will advance into a side branch, as taught by Verard, in order to determine whether the catheter is moving along the intended path.
Barbagli discloses
control rotation of a proximal end of the first percutaneous device about the longitudinal axis of the first percutaneous device and control retraction of the first percutaneous device upon determining whether the first percutaneous device will advance into the side branch [Barbagli teaches such control regardless of whether the side branch is along the projected path].
Re. claim 37, Verard further teaches the control system is further configured to control advancement of the first percutaneous device to avoid the side branch after controlling the retraction [Par. 0133, where the map and desired path is established and updated, after which the device is controlled to follow the path]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Barbagli to avoid a side branch, as taught by Verard, in order to determine whether the catheter is moving along the intended path.
Re. claim 38, Barbagli discloses wherein the control system is further configured to control the rotation of the first percutaneous device to a predetermined amount [because the controller causes the first percutaneous device to rotate, as in Par. 0068, it necessarily includes the predetermined rotation rate, whether or not this rate can be changed].
Claim 39-40 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barbagli in view of Schneider and Verard, as applied to claim 36, and further in view of Hastings et al. [US 20050256398 A1, hereinafter “Hastings”].
Re. claim 39, Barbagli fails to disclose the control system configured to advance the device if the first device is in the desired path. However, Hastings teaches a control system configured to advance the percutaneous device if the first percutaneous device is in a desired path [“determining the orientation for the distal end of the medical device to follow the path input by the user, and orienting the distal end of the medical device in the determined orientation; and automatically advancing the distal end of the medical device along the path,” Hastings Claim 33]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Barbagli such that the control system is configured to advance the device to move along a desired path, as taught by Hastings, in order to allow the catheter to reach its destination [Hastings Par. 0032].
Re. claim 40, the modified Barbagli teaches the apparatus of claim 39 above. Hastings further teaches the control system configured to determine the percutaneous device is in the desired path based on a fluoroscopic image [Hastings Par. 0098, 0015], and it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Barbagli to use a fluoroscopic image as taught by Hastings to determine the correct path because this amounts to a simple substitution of one image type for another known in the art with predictable results.
Response to Arguments
Applicant's arguments filed 2/27/26 have been fully considered but they are not persuasive. Applicant argues that Barbagli and Schneider fail to disclose the predetermined movement profile including a series of pulsed axial steps for advancing while rotating. However, the examiner finds that the above references, in combination, teach a control system which causes the percutaneous device to operate in such a manner. Both references teach rotation and advancement, and Schneider as set forth above teaches the pulsed axial movement. Applicant’s argument appears to hinge on the necessity of the control system determining a predetermined movement profile. However, no such step is required. The movement profile is “predetermined,” yes, but may be predetermined by the user (mentally) or predetermined by the anatomy/geometry of the individual being operated on. Without a clear limitation defining that (or how) the control system determines said movement profile, the above references reasonably convey to one of ordinary skill that the claimed invention that Barbagli-Schneider combined read on the claimed invention.
Applicant alleges that one combining Barbagli and Schneider would “modify Barbagli to have separate modes for rotation and “step or bump” motions; however, no evidence is provided to support this allegation and as Schneider teaches rotational movement also, there is no reason to believe both movements could not be performed at once.
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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/ERIN MCGRATH/ Primary Examiner, Art Unit 3771
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