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 § 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.
Claim(s) 2-4, 7-8, 11-14, 16, 18-20, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blacker (Pub. No.: US 2015/0005738).
Regarding claims 2, 13, 19, Blacker discloses a system, comprising:
a catheter [see 0031-0033];
a computing device (Controller 44), the computing device including a processor and a memory, the memory storing thereon instructions that when executed by the processor:
receive information from the catheter [see 0031, fig 3] by disclosing ultrasound waves may be sent along the guide catheter and the position of the distal end of the guide catheter may be determined based on the return signals received be the ultrasound imaging system [see 0031];
identify, from the received information, movement of a distal portion of the catheter
caused by physiological forces [see 0033];
articulate, based on the identified movement in response to the identified movement caused by the physiological forces, the distal portion of the catheter towards a target during the identified movement of the distal portion of the catheter caused by physiological forces [see 0004, 0033, fig 3] by disclosing controller 44 may be configured to automatically adjust the position of the guide catheter when the guide catheter is moved out of position in response to physiological causes such as the cardiac cycle [see 0033].
Regarding claims 3, 14, Blacker discloses determine an orientation of the distal portion of the catheter relative to a target [see 0019, 0022, 0033] by disclosing images may be displayed on first monitor 28 and/or second monitor 30 to allow the user to, for example, accurately move a guide catheter into the proper position [see 0022].
Regarding claims 4, 20, Blacker discloses wherein the orientation of the distal portion of the catheter is determined using image analysis [see 0022, 0031] by disclosing take one or more x-ray images during a catheter based medical procedure (e.g., real time images) to assist the user of workstation 24 to properly position a guide wire, guide catheter, stent, etc. during the procedure [see 0022].
Regarding claims 7, 16, Blacker discloses wherein the physiological forces are caused by respiration and cardiac functions [see 0033, fig 3] by disclosing controller 44 may be configured to automatically adjust the position of the guide catheter when the guide catheter is moved out of position in response to physiological causes such as the cardiac cycle [see 0033].
Regarding claim 8, Blacker discloses wherein the received signals are during navigation of the catheter towards the target [see abstract, claim 21] by disclosing monitoring the seating of a guide catheter during a catheter procedure [see claim 21].
Regarding claim 11, Blacker discloses receive images depicting the distal portion of the catheter and a target [see fig 3, 0033];
identify the distal portion of the catheter and the target in the images [see fig 3, 0033];
confirm that the distal portion of the catheter is proximate to the target [see fig 3, 0033].
Regarding claim 12, Blacker discloses wherein the images are fluoroscopic or ultrasound images [see abstract].
Regarding claim 18, Blacker discloses detect (via heart rate monitor, emphasis added), based on identified movement of the distal portion of the catheter due to physiological forces, a heart rate and a respiration rate [see 0024].
Claim(s) 5, 15, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Blacker (Pub. No.: US 2015/0005738) in view of Kozuka et al (Pub. No.: US 2014/0236000).
Regarding claims 5, 15, 21, Blacker don't disclose determine a three-dimensional angle between a current orientation of the distal portion of the catheter and an orientation where a vector extending from the distal portion of the catheter intersects the target.
Nonetheless, Kozuka et al disclose determine a three-dimensional angle between a current orientation of the distal portion of the catheter and an orientation where a vector extending from the distal portion of the catheter intersects the target [see 0095, 0101, abstract] by disclosing displays in a plane by a two-dimensional vector the catheter tip-end rotation angle calculated by the catheter tip-end rotation angle calculation unit [see 0095]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Blacker and Kozuka et al by determining a three-dimensional angle between a current orientation of the distal portion of the catheter and an orientation where a vector extending from the distal portion of the catheter intersects the target; to perform a smooth catheter manipulation.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Blacker (Pub. No.: US 2015/0005738) in view of Kozuka et al (Pub. No.: US 2014/0236000) as applied to claim 5 above and further in view of Frisco et al (Pub. No.: US 2010/0249507)
Regarding claim 6, Blacker and Kozuka et al don't disclose articulate the distal portion of the catheter to achieve the orientation where the vector extending from the distal portion of the catheter intersects the target.
Nonetheless, Frisco et al disclose articulate the distal portion of the catheter to achieve the orientation where the vector extending from the distal portion of the catheter intersects the target [see 0010, 0063-0064] by disclosing displaying a graphical representation of the transformed first vector along with a current image captured by the image capturing device on a display screen so as to indicate a direction to steer the tip of the endoscopic device towards the first landmark [see 0010, 0063-0064].
Frisco et al disclose graphical representations of the vectors point in directions that the endoscope tip is to be steered in order to move towards associated landmarks such as anatomic structures in a patient [see abstract].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Blacker, Kozuka et al and Frisco et al by articulating the distal portion of the catheter to achieve the orientation where the vector extending from the distal portion of the catheter intersects the target; in order to provide guidance to the operator for navigating the endoscope 110 to a target site within the patient [see 0043, Frisco et al].
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Blacker (Pub. No.: US 2015/0005738) in view of Viswanathan (Pub. No.: US 2004/0068173)
Regarding claim 9, Blacker don't disclose present on a user interface a virtual catheter tip and a virtual target.
Nonetheless, Viswanathan discloses present on a user interface a virtual catheter tip and a virtual target [see 0006, 0043, figs 58-59] by disclosing the user can identify a target location and the interface uses the virtual device model to determine the control parameter(s) to cause the actual device to reach the target [see 0006]; the user interface in target mode, showing the target cursor, the target, and the virtual device and showing the virtual device extending to a selected target [see 0025-0026].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Blacker and Viswanathan by using a user interface a virtual catheter tip and a virtual target; for identifying a target point to which the virtual medical device configures itself to [see 0006, Viswanathan].
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Altman et al (Pub. No.: US 2007/0106147) in view of Viswanathan (Pub. No.: US 2004/0068173) as applied to claim 9 above and further in view of Duindam et al (Pub. No.: US 2020/0078103).
Regarding claim 10, Blacker and Viswanathan don't disclose present an indicator on the user interface when the physiological forces are in approximately the same phase of their cycle as when the distal portion of the catheter was confirmed oriented at the target.
Nonetheless, Duindam et al disclose present an indicator on the user interface when the physiological forces are in approximately the same phase of their cycle as when the distal portion of the catheter was confirmed oriented at the target [see 0055, 0071, 0085-0089] by disclosing friction forces [see 0086].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Blacker, Viswanathan and Duindam et al by presenting an indicator on the user interface when the physiological forces are in approximately the same phase of their cycle as when the distal portion of the catheter was confirmed oriented at the target; to increase visualization.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Altman et al (Pub. No.: US 2007/0106147) in view of Fish et al (Pub. No.: US 2011/0144657)
Regarding claim 17, Blacker don’t disclose determine a cyclic timing of the movement of the distal portion of the catheter due to physiological forces.
Nonetheless, Fish et al disclose determine a cyclic timing of the movement of the distal portion of the catheter due to physiological forces [see 0108].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Blacker and Fish et al by determining a cyclic timing of the movement of the distal portion of the catheter due to physiological forces; thereby resulting in more accurate stability assessment throughout a procedure and the different phases of the cyclic activity [see 0108, Fish et al].
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 13, 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant arguments are moot due to newly applied reference.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3797
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