DETAILED ACTION
This action is in response to preliminary amendments received on 2/9/2024. It is acknowledged that claim 8 has been amended. A complete action on the merits of claims 1-16 follows below.
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 .
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 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation “periodically calculate and obtain to-be-compared position information according to the spatial position information of the ablation site within a predetermined time period, and periodically compare the to-be-compared position information to the target spatial position information to generate ablation prompt information”. It is at most unclear what “to-be-compared position information” refers to since “the signal input and output module is configured to be connected to at least one medical catheter, and acquire spatial position information of an ablation site according to a current position of the medical catheter when the medical catheter outputs ablation energy” thus a real-time position of the medical device is being acquired. Therefore, it is unclear what is being calculated and obtained by the limitation of “periodically calculate and obtain to-be-compared position information according to the spatial position information of the ablation site within a predetermined time period”. Clarification and appropriate correction is required.
Claims 2-16 are rejected due to dependency over claim 1.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 8-10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Koblish as applied above in view of Koblish (US Pub. No. 2020/0107877) in view of Ninni (US Pub. No. 2022/0202500).
Regarding Claim 1, Koblish teaches an ablation system (Fig. 1), comprising an information processing module 46 (Fig. 1) and a signal input and output module 44 ([0386]) in communication with each other, wherein the signal input and output module is configured to be connected to at least one medical catheter 20, and acquire spatial position information of an ablation site according to a current position of the medical catheter when the medical catheter outputs ablation energy, and transmit the spatial position information of the ablation site to the information processing module ([0011]-[0014], [0050]-[0051] and [0652]-[0656]); and
as best understood in view of the 112 rejection above, the limitation of the information processing module is configured to acquire target spatial position information according to a target ablation site, periodically calculate and obtain to-be-compared position information according to the spatial position information of the ablation site within a predetermined time period, and periodically compare the to-be-compared position information to the target spatial position information to generate ablation prompt information is interpreted such that the processing module is configured to acquire target spatial position information according to a target ablation site, periodically calculate and obtain a trajectory position (to-be-compared position information) according to the spatial position information of the ablation site within a predetermined time period, and periodically compare the trajectory position (to-be-compared position information) to the target spatial position information to generate ablation prompt information (in real-time), which Koblish does not teach.
In the same field of invention, Ninni teaches “A processor generates a virtual image of the real-time position of the sheath and/or the target site, and displays a ghost (non-real-time) position for a tool in the virtual image. Information directing a user to align the distal end of the sheath with the ghost position is displayed on a display screen. The ghost position can be a true prior position that was recorded, or a proposed desired position based on a procedure plan” [0008] and “it would be advantageous to record at least one cycle of the biological cyclic motion waveform and correlate that waveform with the ghost image data to display navigation guidance data to inform the user how to manipulate one or more sections of the sheath along the real-time insertion trajectory such that the real-time insertion trajectory becomes aligned with the target at a desired motion phase” [0082], also see [0085]-[0087].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a trajectory image superimposed over the real-time image of the position of the ablation catheter on the 3D map of the target area in order to allow a user to guide the catheter to the correct position and orientation during the ablation procedure while monitoring and constantly comparing the two images together on the screen as Ninni teaches (see Figs. 3-5B).
Regarding Claim 2, Koblish in view of Ninni teaches wherein the information processing module is further configured to record the target spatial position information as spatial position information of an ablated site when the medical catheter completes ablation if a distance calculated according to the current to-be-compared position information within the current predetermined time period and the target spatial position information is less than or equal to a first preset distance (“The ghost position can be a true prior position that was recorded” [0008] and “the software system can indicate to the user when the difference between a ghost image 430 (recorded sheath position and/or orientation) and a real-time image 432 (real-time sheath position and/or orientation) is within a certain threshold … finally at Position 3, as the two images substantially overlap with each other to within a predetermined threshold (Th), the indicator becomes a verification marker (a checkmark) so the user can be informed that the alignment has been completed. At Position 3, in the case that the two images cannot be sufficiently overlapped within the threshold (Th), the verification marker can become an “X” shaped mark instead of a checkmark” [0063] and [0051]-[0052] of Ninni).
Regarding Claim 3, Koblish in view of Ninni teaches wherein the information processing module is further configured to output a prompt indicating that an ablation position moves when the distance calculated according to the current to-be-compared position information within the current predetermined time period and the target spatial position information is greater than the first preset distance (position 1 and position 2 in Figs. 5A-B, [0063] of Ninni).
Regarding Claim 4, Koblish in view of Ninni teaches wherein the information processing module is further configured to compare the current to-be-compared position information within the current predetermined time period to spatial position information of a previously ablated site, and output a prompt indicating repeated ablation when a distance calculated according to the current to-be-compared position information within the current predetermined time period and the spatial position information of the previously ablated site is less than a second preset distance (“trajectory information is stored in a memory of the system and continuously updated. After a short advance in insertion distance, the shape of the steerable sheath is corrected by adjusting (twisting and/or bending) segments of the instrument in such a way that the new shape closely matches the desired trajectory. This process is repeated until a target area is reached” [0048] and [0058] of Ninni).
Regarding Claim 8, Koblish in view of Ninni teaches wherein the signal input and output module is further configured to acquire modeling spatial position information according to spatial position information of a distal end of the medical catheter (tip electrode icon [0816]-[0817] of Koblish) and transmit the modeling spatial position information to the information processing module, and the information processing module is further configured to construct a three-dimensional geometric model of a region in which the distal end of the medical catheter is located according to the modeling spatial position information and mark the generated ablation prompt information into the three-dimensional geometric model (“in terms of the steerable catheter sheath 110 and any interventional tool inserted through the sheath, the alignment refers to the “matching” of the recorded (non-real-time) coordinates with real-time coordinates of the position and orientation relationship between the distal tip of the sheath and the target site. In other words, while the display screen 420 may show a 2D position difference between the ghost image and the real-time image, a difference between the desired or recorded coordinates and the real-time coordinates of the sheath 110 with respect to the target site is considered in a 3D space. Hence, it is important that the software system can allow the user to observe the realignment in as many views as possible” [0062] of Ninni).
Regarding Claim 9, Koblish teaches further comprising: an ablation energy module 42, connected to the medical catheter 20 (Fig. 1 of Koblish), and configured to generate an ablation signal according to ablation parameters, to allow the medical catheter 20 to output the ablation energy ([0385]-[0387] of Koblish); and a display module, in communication with the information processing module, and configured to display the three-dimensional geometric model and the ablation prompt information ([0007], [0652]-[0656] of Koblish, also see display screen 420 in [0063]-[0063] and Figs. 4A-5B of Ninni).
Regarding Claim 10, Koblish teaches wherein the ablation prompt information comprises marker color information, and ablation prompt information of different marker types corresponds to different marker color information ([0008], [0293], [0677], [0832] of Koblish and [0062]-[0063], [0068] of Ninni).
Regarding Claim 16, Koblish teaches wherein the three-dimensional geometric model comprises renal artery vessels and/or abdominal aorta segment vessels ([0384] and [0484]).
Allowable Subject Matter
Claims 5-7 and 11-15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding Claim 5, Koblish in view of Ninni teaches the invention as applied above; however, neither alone or in combination teach the combination of the limitations with further comprising: a physiological stimulation module, connected to the medical catheter, and configured to generate a stimulation signal according to a stimulation parameter, to allow the medical catheter to output stimulation energy; and a physiological parameter detection module, configured to detect a physiological parameter generated in response to the stimulation signal, and transmit the physiological parameter to the information processing module, wherein when the medical catheter outputs the stimulation energy, the information input and output module is configured to acquire spatial position information of a stimulation site according to the current position of the medical catheter and transmit the spatial position information of the stimulation site to the information processing module, the information processing module is further configured to generate the ablation prompt information according to the physiological parameter and the spatial position information of the stimulation site, wherein the ablation prompt information comprises recommended ablation site information and unrecommended ablation site information.
Regarding Claim 11, Koblish in view of Ninni teaches the invention as applied above, but does not specifically teach further comprising an ablation effect determination module configured to calculate an ablation effect index, wherein the ablation effect index depends on ablation parameters comprising an ablation power, a loss power, a surface area of an ablation electrode, and an ablation duration.
Claims 6-7 and 12-15 are objected due to dependency over claims 5 and 11.
Conclusion
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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