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 application filed on 12/01/2024. Claims 1-10 are currently pending and have been examined.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea), and does not include additional elements that either: 1) integrate the abstract idea into a practical application, or 2) that provide an inventive concept — i.e. element that amount to significantly more than the abstract idea. The Claims are directed to an abstract idea because, when considered as a whole, the plain focus of the claims is on an abstract idea.
STEP 1
The claims are directed to a system and method which is included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims recite the abstract idea (based on claim 10) of:
An operation method, the method comprising: acquiring 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; and calculating a puncture difficulty level of puncturing from the puncture candidate position to the puncture target by using the puncture information.
The claims, as illustrated by the limitations of Claim 10 above, recite an abstract idea within the “mathematical concepts” grouping — mathematical relationships, mathematical formulas or equations, mathematical calculations.
The claims recite calculating a puncture difficulty level of puncturing from the puncture candidate position to the puncture target by using the acquired puncture information. Calculating a puncture difficulty level of puncturing from the puncture candidate position to the puncture target by using the acquired puncture information is a process that merely mathematical calculations, as it involves acquiring data and using the acquired data to calculate a difficulty level. As such, the claims recite an abstract idea within the category of mathematical concepts.
The dependent claims 5 and 7-9 recite further abstract ideas within the category of mathematical concepts, such as 5 the puncture difficulty level is calculated for a plurality of the puncture candidate positions; 7 the puncture difficulty level is calculated by using an angle between a gravity direction in which gravity occurs and a puncture direction from the puncture candidate position toward the puncture target; 8 the puncture difficulty level is calculated by using at least one of a distance from the puncture candidate position to the puncture target and a size of the puncture target; 9 the puncture difficulty level is calculated by using information on blood vessels in the puncture target part. Dependent claims 2-4 and 6 recite further abstract ideas within the category of certain methods of organizing human activity, such as 2 the puncture difficulty level is notified; 3 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; 4 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; 6 the puncture information is acquired by using an ultrasound image obtained from a reflected wave of an ultrasound wave emitted from the surface of the puncture target part toward its interior.
STEP 2A PRONG TWO
The claims recite additional elements beyond those that encompass the abstract idea above including:
Independent claim 1:
A processor device configured to
Dependent claim 2:
The processor device
Dependent claim 3:
The processor device
Dependent claim 4:
The processor device
Dependent claim 5:
The processor device
Dependent claim 6:
The processor device
Dependent claim 7:
The processor device
Dependent claim 8:
The processor device
Dependent claim 9:
The processor device
Independent claim 10:
A processor device
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with considerations laid out by the Supreme Court or the Federal Circuit. (see MPEP 2106.05 a-c and e) The additional elements integrate the abstract idea into a practical application when they: improve the functioning of a computer or improving any other technology, apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, apply the judicial exception with, or by use of, a particular machine, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. The additional limitations do not integrate the abstract idea into a practical application when they merely serve to link the use of the abstract idea to a particular technological environment or field of use — i.e. merely uses the computer as a tool to perform the abstract idea; or recite insignificant extra-solution activity (see MPEP 2106.05 f - h).
The processor device is recited at a high level of generality such that it amounts to no more than instructions to apply the abstract idea using generic computer components. These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular technological environment. Nothing in the claim recites specific limitations directed to an improved processor device. Similarly, the specification is silent with respect to these kinds of improvements. A general purpose computer that applies a judicial exception to computer functions, as is the case here, does not qualify as a particular machine, nor does the recitation of a basic computer impose meaningful limits in the claimed process. (see Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17 (Fed. Cir. 2014)). As such, the additional elements recited in the claims do not integrate the abstract puncture difficulty calculation into a practical application of that calculation.
STEP 2B
The additional elements identified above do not amount to significantly more than the abstract puncture difficulty calculation. The additional structural elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generic computer structure. Because the specification describes these additional elements in general terms, without describing particulars, Examiner concludes that the claim limitations may be broadly, but reasonably construed, as reciting basic computer components and techniques. The specification describes the elements in a manner that indicates that they are sufficiently straightforward such that the specification does not need to describe the particulars in order to satisfy U.S.C. 112. Considered as an ordered combination, the limitations recited in the claims add nothing that is not already present when the steps are considered individually.
The limitations recited in the dependent claims, in combination with those recited in the independent claims add nothing that integrates the abstract idea into a practical application, or that amounts to significantly more. For example, dependent claim limitations 5 the puncture difficulty level is calculated for a plurality of the puncture candidate positions; 7 the puncture difficulty level is calculated by using an angle between a gravity direction in which gravity occurs and a puncture direction from the puncture candidate position toward the puncture target; 8 the puncture difficulty level is calculated by using at least one of a distance from the puncture candidate position to the puncture target and a size of the puncture target; 9 the puncture difficulty level is calculated by using information on blood vessels in the puncture target part are directed to the abstract idea of mathematical calculations without integrating into a practical application or amounting to significantly more. Dependent claim limitations 2 the puncture difficulty level is notified; 3 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; 4 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; 6 the puncture information is acquired by using an ultrasound image obtained from a reflected wave of an ultrasound wave emitted from the surface of the puncture target part toward its interior are directed to the abstract idea of certain methods of organizing human activity without integrating into a practical application or amounting to significantly more.. Therefore, the claims are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5, and 6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shimura, et al. (US 2004/0087855 A1).
With regards to claim 1, Shimura teaches a processor device (see at least figure 1 (10), ¶ 0084-0086, a puncture difficulty evaluating device 10 shown in FIG. 1, ultrasound reflected at the POI is picked up by the ultrasonic transducers arranged in the ultrasonic probe 11, and the resulting signals are received by a receiver circuit 12, echo signal, which results from the reception of the ultrasound by the receiver circuit 12, is temporarily stored in a received time-series signal memory 14 by a writing circuit 13 in a time series manner, and then read therefrom by a reading circuit 15. Then, the signals obtained in the ultrasonic transducers located within a range defined by a predetermined angle with respect to the line from the POI to the ultrasonic probe 11 (within a range of an angle 2.theta. defined by a half angle .theta. in FIG. 1) are added to each other with being in phase with each other, by an adder circuit 16. In this way, the integral value of the powers of the ultrasounds reflected off the POI with respect to the range defined by the predetermined angle (half angle of .theta.) is obtained. The integral value is input to a parameter generating section 17, and the parameter generating section 17 calculates a parameter which serves as an indicator for evaluating the difficulty of puncture in the POI) configured to: acquire 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 figure 1, POI; ¶ 0125 – 0127, part of a human arm, blood vessel inside arm, find a part of the surface of the blood vessel which is enough hardened to be difficult to puncture or a part thereof which is easy to puncture); and calculate a puncture difficulty level of puncturing from the puncture candidate position to the puncture target by using the puncture information (see at least ¶ 0123, an operator manipulates the manipulation section 27 to specify a region of interest (ROI), which is a set of points of interest (POIs) for which the SIBV(.theta.) is to be measured, on the B-mode image displayed on the display section 26. The ROI specification information is stored in the bit map 25. Regarding each point in the specified ROI as a POI based on the ROI specification information from the bit map 25, the SIBV(.theta.) measuring circuit 20 transmits an ultrasound, receives the reflected ultrasound and calculates the SIBV(.theta.) for each POI).
Claim 10 recites similar limitations regarding the method and is rejected for the same reasons.
With regards to claim 2, Shimura teaches the processor device according to claim 1, wherein the puncture difficulty level is notified (see at least ¶ 0086, calculated parameter is transmitted to a display section 18, where the difficulty of puncture in the POI is displayed in the form of a numeric value, an image (luminance or color) or the like).
With regards to claim 3, Shimura 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 ¶ 0042, the puncture difficulty evaluating device according to the present invention preferably has a B-mode image generating section that transmits an ultrasonic pulse to the specimen, receives an ultrasound backscattered in the specimen and generates a B-mode image, and an image display section that displays the B-mode image and an indication of the difficulty of puncture at the measurement point on the B-mode image, the indication being generated based on the parameter generated in said parameter generating section; ¶ 0086, a parameter which serves as an indicator for evaluating the difficulty of puncture in the POI. The calculated parameter is transmitted to a display section 18, where the difficulty of puncture in the POI is displayed in the form of a numeric value, an image (luminance or color) or the like).
With regards to claim 5, Shimura 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 ¶ 0125, In a B-mode image 220 shown in part (A) of FIG. 9, an arm surface 221 and a blood vessel 222 extending horizontally below the arm surface can be seen. If an ROI 230 is specified on the B-mode image 220 via the manipulation section 27 shown in FIG. 8, values of SIBV(.theta.) are displayed at points in the ROI 230 by their respective associated colors).
With regards to claim 6, Shimura teaches the processor device according to claim 1, wherein the puncture information is acquired by using 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 ¶ 0121, B-mode measuring unit 22 is to apply an ultrasound transmission driving pulse to the ultrasonic probe 11 via the mode switch 21 to make it transmit an ultrasound into the specimen, amplify the echo signal obtained by the ultrasonic probe 11 picking up the ultrasound reflected at the inside of the specimen, perform a signal processing such as dynamic focusing on the echo signal to obtain information for each scan line, and write the information to the DSC (B) 23. One frame of B-mode image signal is obtained by repeating such transmission, reception and writing to the DSC (B) 23, converted into a signal suitable for display on the display section 26 and transmitted to the display section 26, whereby the B-mode image is displayed on the display section 26.).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Shimura, et al. (US 2004/0087855 A1) in view of Yuan, et al. (US 2023/0329749 A1).
With regards to claim 4, Shimura 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 … image that includes the puncture target part.
Shimura does not explicitly teach …the three-dimensional... Yuan teaches …the three-dimensional... (see at least ¶ 0132). It would have been obvious to one of ordinary skill in the art to combine the 3-D ultrasound image of Yuan with the puncture difficulty evaluation system of Shimura with the motivation of more accurate puncture, diagnosis, and treatment (Yuan, ¶ 0004).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Shimura, et al. (US 2004/0087855 A1) in view of Aoyagi (US 2018/0325600 A1).
With regards to claim 7, Shimura teaches the processor device according to claim 1, wherein the puncture difficulty level is calculated by using an angle (see at least ¶ 0033, puncture difficulty evaluating-device according to the present invention is based on a principle that a parameter indicating the difficulty of puncture is generated based on the integral of the ultrasound backscattered at the measurement point over the predetermined angle range)
Shimura does not explicitly teach …between a gravity direction in which gravity occurs and a puncture direction from the puncture candidate position toward the puncture target. Aoyagi teaches …between a gravity direction in which gravity occurs and a puncture direction from the puncture candidate position toward the puncture target (see at least ¶ 0111, insertion point candidate region display control unit 322 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, while assigns a low score when the distance from the center of gravity of the puncture insertion candidate region to the puncture target is relatively long). It would have been obvious to one of ordinary skill in the art to combine the gravity use method of Aoyagi with the puncture difficulty evaluation system of Shimura with the motivation of optimization of insertion point of a puncture needle (Aoyagi, ¶ 0012).
With regards to claim 8, Shimura teaches the processor device according to claim 7, wherein the puncture difficulty level is calculated by using at least one of a distance from the puncture candidate position to the puncture target and a size of the puncture target (see at least ¶ 0095, the value of SIBV, i.e. difficulty of puncture, depends of the distance between target (figure 9, vessel 220) and puncture position candidate, figure 3).
With regards to claim 9, Shimura teaches the processor device according to claim 8, wherein the puncture difficulty level is calculated by using information on blood vessels in the puncture target part (see at least ¶ 0095, the value of SIBV, i.e. difficulty of puncture, depends of the distance between target (figure 9, vessel 220) and puncture position candidate, figure 3).
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.
L. Zheng, H. Wu, L. Yang, Y. Lao, Q. Lin and R. Yang, "A Novel Respiratory Follow-Up Robotic System for Thoracic-Abdominal Puncture," in IEEE Transactions on Industrial Electronics, vol. 68, no. 3, pp. 2368-2378, March 2021, doi: 10.1109/TIE.2020.2973893 which discloses application of robotic puncture system in thoracic-abdominal puncture (TAP) surgery has been hindered by the undistinguished accuracy on account of the respiratory motion. In order to mitigate this challenge, a respiratory follow-up robotic system (RFRS) is designed for accurate surgical puncture. Notably, a control strategy on robotic puncture is proposed to compensate the tissue deformation under the effect of clinical respiration. With the real-time analysis of breathing motion, the movement of robotic arm is composed by follow-up compensation related to respiratory motion and insertion toward the target. An online target location model proposed here aims to restrict the surgical instrument overlapped with the planned target, increasing the accuracy, safety, flexibility, and agility of puncture procedures. Experimental results suggest that the presented system achieved outperforming accuracy, movement capabilities, and robustness. It is promising that the RFRS will be effective in TAP by analyzing breathing motion for tissue deformation compensation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joey Burgess whose telephone number is (571)270-5547. The examiner can normally be reached Monday through Friday 9-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached on 571-272-6702 The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D BURGESS/ Primary Examiner, Art Unit 3685
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