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 .
Status of Claims
This action is in reply to an amendment filed on 07/20/2026. Claims 1 and 10 have been amended. Claims 6-9 have been cancelled. No claims have been added. Therefore, claims 1-5 and 10 are currently pending and have been examined.
Claim Rejections - 35 USC § 103
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.
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 1-5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Aoyagi (US 2018/0325600 A1) in view of Sarvestani, et al. (US 2013/0066192 A1).
With regards to claim 1, Aoyagi teaches a processor device (see at least ¶ 0056) configured to: acquire an ultrasound image obtained from a reflected wave of an ultrasound wave emitted from the surface of the puncture target part toward its interior (see at least ¶ 0033, The ultrasonic diagnostic device is an image diagnostic device that applies ultrasonic waves to a subject and visualizes echoes thereof; ¶ 0036, The ultrasonic diagnostic device 400 images a position of an affected area of the subject or a puncture needle acquired by an ultrasonic probe in puncture, and displays the imaged site); detect, from the ultrasound image, puncture information related to a puncture candidate position on a surface of a puncture target part and a puncture target inside the puncture target part (see at least ¶ 0028, a puncture target setting unit configured to set a puncture target in the acquired volume data; a puncturable region setting unit configured to set a puncturable region on a body surface image extending from the body surface to the set puncture target...; a puncture route extraction unit configured to extract a puncture route from the set puncturable region on the body surface image to the puncture target; ¶ 0114, the workstation 300 acquires the three-dimensional volume data from the image server 200... sets the puncture target OB in the volume data); calculate a puncture difficulty level of puncturing from the puncture candidate position to the puncture target by using the puncture information, comprising …, a distance from the puncture candidate position to the puncture target (see at least ¶ 0086, 0089, the safety degree calculation unit 320 calculates a safety degree based on a positional relationship between each puncture route of a puncture route group and a protection target... safety degrees are calculated from distances from protection targets (PO1 to PO4) to the puncture route PRm; ¶ 0110, adjacent points are connected of the set of points in the group of the high safety degree region AA in the puncturable region ER, and divided into a plurality of clusters. The insertion point candidate region display control unit 322 handles each cluster as a puncture insertion candidate region (for example, CA1, CA2), and calculates an area of each puncture insertion candidate region, and a distance from the center of gravity of each puncture insertion candidate region to the puncture target OB), and a size of the puncture target (see at least ¶ 0110, adjacent points are connected of the set of points in the group of the high safety degree region AA in the puncturable region ER, and divided into a plurality of clusters. The insertion point candidate region display control unit 322 handles each cluster as a puncture insertion candidate region (for example, CA1, CA2), and calculates an area of each puncture insertion candidate region, and a distance from the center of gravity of each puncture insertion candidate region to the puncture target OB; ¶ 0111, assigns a high score when the calculated area of the puncture insertion candidate region is relatively large... assigns a high score when the distance from the center of gravity of the puncture insertion candidate region to the puncture target is relatively short); and display the puncture difficulty level superimposed on an image of the puncture target part, thereby guiding selection of a puncture position for performing a puncture with a puncture needle on the puncture target (see at least ¶ 0102, the insertion point candidate region display control unit 322 divides the puncturable region ER into groups based on the calculated safety degrees, and displays the safety degrees of puncture in different colors on the body surface image... a high safety degree region ... is blue ... a high unsafety degree region ... is red).
Aoyagi does not explicitly teach …an angle between a puncture direction from the puncture candidate position toward the puncture target and a gravity direction. Sarvestani teaches …an angle between a puncture direction from the puncture candidate position toward the puncture target and a gravity direction (see at least ¶ 0005, this is often performed with the assistance of computer system controlled with appropriate software, which will calculate a pitch angle and a yaw angle with respect to a vertical gravity vector and a coordinate system relative to the CT scanner; ¶ 0012, the trajectory guide further includes at least one electronic angle sensor associated with the axial guide member and adapted to automatically sense a first angle of the axial guide member relative to the local gravity vector about the first axis and a second angle... relative to the local gravity vector about the second axis; ¶ 0028, an integrated angle sensor 208 that measures the angle of the guiding sleeve 204 with respect to the local vertical gravity vector... automatically measures the angle of the longitudinal axis 212... relative to the local gravity vector and outputs digital angular data). It would have been obvious to one of ordinary skill in the art to combine the gravity vector of Sarvestani with the puncture support device of Aoyagi with the motivation of easier guiding of an axial medical instrument during a procedure (Sarvestani, ¶ 0002, 0004-0011).
Claim 10 recites similar limitations as to the method of the device and is rejected for the same reasons.
With regards to claim 2, Aoyagi teaches the processor device according to claim 1, wherein the puncture difficulty level is notified (see at least ¶ 0102, the insertion point candidate region display control unit 322 divides the puncturable region ER into groups based on the calculated safety degrees, and displays the safety degrees of puncture in different colors on the body surface image... a high safety degree region ... is blue ... a high unsafety degree region ... is red; ¶ 0115, the operator can easily have a look at the candidate regions of the plurality of puncture insertion points with a high safety degree on the body surface image, and can select a puncture insertion point for the safest puncture).
With regards to claim 3, Aoyagi teaches the processor device according to claim 2, wherein the notification is performed by displaying the puncture candidate position and the puncture difficulty level superimposed on an optical image obtained by imaging the puncture target part (see at least ¶ 0102, the insertion point candidate region display control unit 322 divides the puncturable region ER into groups based on the calculated safety degrees, and displays the safety degrees of puncture in different colors on the body surface image... a high safety degree region ... is blue ... a high unsafety degree region ... is red; ¶ 0103, the safety degree map displaying the safety degrees in different colors on the body surface image to be the display unit 346 [optical image]).
With regards to claim 4, Aoyagi teaches the processor device according to claim 2, wherein the notification is performed by displaying the puncture candidate position and the puncture difficulty level superimposed on a three-dimensional image that includes the puncture target part (see at least ¶ 0102, the insertion point candidate region display control unit 322 divides the puncturable region ER into groups based on the calculated safety degrees, and displays the safety degrees of puncture in different colors on the body surface image... a high safety degree region ... is blue ... a high unsafety degree region ... is red; ¶ 0114, the workstation 300 acquires the three-dimensional volume data from the image server 200... sets the puncture target OB in the volume data).
With regards to claim 5, Aoyagi teaches the processor device according to claim 1, wherein the puncture difficulty level is calculated for a plurality of the puncture candidate positions (see at least ¶ 0110, adjacent points are connected of the set of points in the group of the high safety degree region AA in the puncturable region ER, and divided into a plurality of clusters. The insertion point candidate region display control unit 322 handles each cluster as a puncture insertion candidate region (for example, CA1, CA2), and calculates an area of each puncture insertion candidate region, and a distance from the center of gravity of each puncture insertion candidate region to the puncture target OB; ¶ 0115, the operator can easily have a look at the candidate regions of the plurality of puncture insertion points with a high safety degree on the body surface image, and can select a puncture insertion point for the safest puncture).
Response to Arguments
Applicant's arguments with respect to the 35 USC § 101 rejections set forth in the previous office action have been considered, and are persuasive. Therefore, these rejections are withdrawn.
Applicant's arguments with respect to the 35 USC § 102 and 103 rejections set forth in the previous office action have been considered, but are moot in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Matsumoto (US 2022/0160335 A1) which discloses an ultrasound diagnostic apparatus capable of appropriately highlighting a blood vessel in an ultrasound image depending on an insertion situation of an insert, and a method of controlling the same. An ultrasound diagnostic apparatus 1 includes a transducer array 2, an image acquisition unit 11 that acquires an ultrasound image, a display device 8 that displays the ultrasound image, an image analysis unit 9 that analyzes the ultrasound image to detect a blood vessel and an insert in the ultrasound image, a highlighting unit 10 that highlights the blood vessel detected by the image analysis unit 9 in displaying the ultrasound image, and an apparatus controller 13 that controls the highlighting unit 10. The apparatus controller 13 performs control such that the highlighting unit 10 changes a form in highlighting the blood vessel depending on a relative positional relationship between the blood vessel and the insert
Takagi (US 2015/0150591 A1) which discloses a puncture control system includes a trajectory error compensation filter for outputting a control signal for compensating for the error of a puncture needle from a target trajectory based on information on the position of the puncture needle obtained by a detector, a displacement compensation filter for which initial control parameters are determined based on a model representing characteristics of an organ, and an adder for outputting an added signal obtained by adding outputs of the trajectory error compensation filter and the displacement compensation filter. The organ model is used to predict a displacement of a puncture target position and sequentially determine a course of the puncture needle.
Tanaka Y, Tanaka K, Shiomi H, Kurumi Y, Tani T, Ogura Y. Needle Tip Detection Using Ultrasound Probe for Vertical Punctures: A Simulation and Experimental Study. Diagnostics (Basel). 2022 Feb 18;12(2):527. doi: 10.3390/diagnostics12020527. PMID: 35204616; PMCID: PMC8871038 which discloses current ultrasound-guided punctures are difficult to perform as they are performed at an angle to the ultrasound image of the affected area, resulting in longer puncture times, lower success rates, and higher unexpected injury rates. Vertical puncture techniques have also been investigated, but the principle of needle tip detection remains unclear. To optimize ultrasound probes for puncture, the principle of needle tip detection should be understood. This study aimed to verify the principle of needle tip detection and optimal measurement conditions for vertical puncture. Needle tip detection was performed in animal experiments using a probe with a central puncture slit. Moreover, the needle tip was detected at short distances using a puncture spacer. We also investigated the signal from the needle tip using a ring probe and confirmed the principle of needle tip detection, effect of needle tip angle, and insertion depth on needle tip detection through simulation and experiments. Needle tip detection using ultrasound-guided waves was described, and the relationship among needle tip angle, detection intensity, and phase change was verified. The needle tip can be detected by the leakage of the ultrasound-guided wave generated inside the needle tip.
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 extension fee 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 date of this final action.
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/JOSEPH D BURGESS/ Primary Examiner, Art Unit 3685
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