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 .
Response to Amendment
The amendment filed on February 19th, 2026 has been entered. Claims 1- 19 and 21 are pending in the application.
Claim Objections
Claims 1- 19 and 21 are objected to because of the following informalities:
Claim 1, Line 17 states “a cutter having a material that are more”, it is suggested to change this to “a cutter having a material that is more”.
Claims 2- 10 and 21 are objected to for being dependent on or from objected claim 1.
Claim 2, Lines 2-3 state “the motor configured to rotate the drive shaft, and the cutter attached”, it is suggested to change this to “a motor configured to rotate the drive shaft, and a cutter attached”.
Claims 3-8 are objected to for being dependent on or from objected claim 2.
Claim 11, Line 15 states “a cutter having a material that are more”, it is suggested to change this to “a cutter having a material that is more”.
Claims 12- 19 are objected to for being dependent on or from objected claim 11.
Claim 12, Lines 2-3 state “the motor configured to rotate the drive shaft, and the cutter attached”, it is suggested to change this to “a motor configured to rotate the drive shaft, and a cutter attached”.
Claims 13-18 are objected to for being dependent on or from objected claim 12.
Appropriate correction is required.
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- 19 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to aa judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106/04, each of claims 1- 19 and 21 have been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of claims 1- 19 and 21 recite at least one step or instruction for ranking the first devices or the treatment methods for removing the target object using the device information and the target information, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106/04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I). The claimed limitation involves an abstract mental process, as the controller determines the hardness of a lesion based on the target information and determine a grade of recommendation for each atherectomy device based on the determined hardness of the lesion and one or both of the rotation speed of the motor of each atherectomy device and the material of the cutter of each atherectomy device, wherein a higher grade is given to an atherectomy device with a motor having a rotation speed and a cutter having a material that are more suitable for cutting the lesion of the determined hardness and suitability of the atherectomy devices to lesions having different characteristics is updated based on prior treatments of the lesions by the atherectomy devices.
Claims 1- 19 and 21 recite an abstract idea.
Specifically, Claim 1 recites a medical system for removing an object in a body cavity, comprising: a display, and a controller connectable to a drive device configured to control a medical device operated by an operator to remove the object, wherein the controller is configured to: acquire device information indicating features of different types of first devices connectable to the medical device, the features including a rotation speed of a motor of each atherectomy device and a material of a cutter of each atherectomy device, acquire target information indicating characteristics of the lesion, determine hardness of the lesion based on the target information, determine a grade of recommendation for each atherectomy device based on the determined hardness of the lesion and one or both of the rotation speed of the motor of each atherectomy device and the material of the cutter of each atherectomy device, wherein a higher grade is given to an atherectomy device with a motor having a rotation speed and a cutter having a material that are more suitable for cutting the lesion of the determined hardness, and suitability of the atherectomy devices to lesions having different characteristics is updated based on prior treatments of the lesions by the atherectomy devices, generate a first screen including: information indicating the hardness of the lesion, a list of atherectomy devices and the corresponding grades in a descending order of the grades, and a location of the lesion to be removed, and control the display to display the first screen.
Specifically, Claim 11 recites a treatment aid apparatus for aiding an operator of a medical device to remove an object in a body cavity, comprising: a display, and a processor configured to: acquire device information indicating features of different types of atherectomy devices connectable to the medical device, the features including a rotation speed of a motor of each atherectomy device and a material of a cutter of each atherectomy device, acquire target information indicating characteristics of the lesion, determine hardness of the lesion based on the target information, determine a grade of recommendation for each atherectomy device based on the determined hardness of the lesion and one or both of the rotation speed of the motor of each atherectomy device and the material of the cutter of each atherectomy device, wherein a higher grade is given to an atherectomy device with a motor having a rotation speed and a cutter having a material that are more suitable for cutting the lesion of the determined hardness, and generate a first screen including: information indicating the hardness of the lesion, a list of atherectomy devices and the corresponding grades in a descending order of the grades, and a location of the lesion to be removed, and control the display to display the first screen.
Further, dependent claims 2-10, 12- 19, and 21 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/ steps are performed.
Accordingly, as indicated above, each of the above- identified claims recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in each of independent Claims 1 and 11 (and their respective dependent Claims 2- 10, 12- 19, and 21) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1 and 11 in bold), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of: a display and generating and controlling the display, a controller, acquiring device information and target information as recited in independent Claim 1 and its dependent claims; and a display and generating and controlling the display, a processor, acquiring device information and target information as recited in independent Claim 11 and its dependent claims, are generically recited computer elements in independent Claims 1 and 11 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1 and 11 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., controller or processor as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 11 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1 and 11 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claims 1- 19 and 21 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims require the additional elements of: a display and generating and controlling the display, a controller, acquiring device information and target information as recited in independent Claim 1 and its dependent claims; and a display and generating and controlling the display, a processor, acquiring device information and target information as recited in independent Claim 11 and its dependent claims.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the controller has a memory, a processor, an information management unit, a computing unit, and an information output unit (Paragraphs 0048 and 0050)(Fig. 3) which are generic components of a controller. The display is also given a generic component of a monitor (Paragraph 0049).
Accordingly, in light of Applicant’s specification, the claimed term controller is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the controller. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1-19 and 21 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system and apparatus of Claims 1- 19 and 21 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 and 11 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 1- 19, and 21 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1- 19, and 21 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1, 2, 9-12, 19 and 21 under 35 U.S.C. 103 over Shelton, IV et al. (US 2019/0125458) in view of Farago et al. (US 2019/0209204) has been withdrawn in view of applicant’s arguments regarding Shelton failing to teach the claim limitation of determining hardness of a lesion and the displaying of ranked devices.
The rejection of claims 3, 4, 13, and 14 under 35 U.S.C. 103 over Shelton, IV et al. (US 2019/0125458) in view of Farago et al. (US 2019/0209204) has been withdrawn in further view of Rauniyar et al. (US 2018.0325619) in view of applicant’s arguments regarding Shelton failing to teach the claim limitation of determining hardness of a lesion and the displaying of ranked devices.
The rejection of claims 5 and 15 under 35 U.S.C. 103 over Shelton, IV et al. (US 2019/0125458) in view of Farago et al. (US 2019/0209204) in further view of Rauniyar et al. (US 2018/0325619) and in view of Kadavy et al. (US 6,443,967) has been withdrawn in view of applicant’s arguments regarding Shelton failing to teach the claim limitation of determining hardness of a lesion and the displaying of ranked devices.
Claim(s) 1-4, 9- 14, 19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, IV et al. (US 2019/0125458) in view of Farago et al. (US 2019/0209204), in view of Rauniyar et al. (US 2018/0325619), and in view of Megerian et al. (US 2020/0273571).
Regarding claims 1 and 11, Shelton (Shelton, IV et al.) teaches a medical system (cloud-based analytics system)(Paragraph 1495)(Fig. 180- 184), comprising: a display (Paragraph 1502), a processor (7008) and a cloud (7004)(As the cloud system as taught by Shelton has a memory, processor, information management unit, it is considered a controller as set forth in Applicant’s specification (Paragraphs 0048 and 0050).) connectable to a drive device (hub 7006) configured to control a medical device (7012) operated by an operator (Paragraph 1496), wherein the controller is configured to: acquire device information indicating features of different types of devices connectable to the medical device, the feature including the type of device, a device’s capacity for a procedure, and a device with a specific parameter set (Paragraphs 1536, 1543, 1555, and 1558) and acquire target information indicating characteristics of the target location (Paragraphs 1551 and 1552). Shelton teaches generating a first screen providing a recommendation and the controller able to control the display to display the first screen (Paragraph 1555).
Shelton does not teach removing a lesion in a blood vessel, the features of the different atherectomy devices connectable to the medical device, the features including a rotation speed of a motor of each atherectomy device and a material of a cutter of each atherectomy device, the device information including a rotation speed of a motor of each atherectomy device and a material of a cutter of each atherectomy device, acquiring target information indicating characteristics of the lesion, determine hardness of the lesion based on the target information, determine a grade of recommendation for each atherectomy device based on the determined hardness of the lesion and one or both of the rotation speed of the motor of each atherectomy device and the material of the cutter of each atherectomy device, wherein a higher grade is given to an atherectomy device with a motor having a rotation speed and a cutter having a material that are more suitable for cutting the lesion of the determined hardness and suitability of the atherectomy devices to lesions having different characteristics are updated based on prior treatments of the lesions by the atherectomy devices, or wherein the first screen includes information indicating the hardness of the lesion, a list of the atherectomy devices and the corresponding grades in a descending order of the grades, and a location of the lesion to be removed.
Farago (Farago et al.) teaches a medical system (atherectomy system 10)(Figs. 1-5)(abstract) comprising a display (30), a processor (Paragraph 0057) and a controller (control unit 14) connectable to a drive device (motor 37) configured to control a medical device (advancer assembly 16, drive shaft 18, and an elongated member 22) operated by an operator to remove the object (Paragraphs 0047, 0058, and 0059), wherein the controller is configured to acquire target information indicating characteristics of a target object to be removed (Paragraphs 0068 and 0071). Farago further teaches wherein the medical device has an atherectomy device (rotational device 20) connected to it (Paragraph 0047 and 0053), the atherectomy device including a rotation speed of a motor (Paragraph 0048 and 0057), and the controller storing this information as well as other information about the device within it (Paragraph 0066).
It would have been obvious to one of ordinary skill in the art to modify the medical system and the devices of the system to be atherectomy devices and to acquire target information indicating characteristics of a target object to be removed as taught by Farago, since both Shelton and Farago teach that the medical systems are used in a surgical procedure (Shelton, Paragraph 0003; Farago, Paragraph 0003) and both teach that the surgical instruments are controlled by a controller (Shelton, Paragraph 1495; Farago, Paragraphs 0054 and 0058) and it would have been a matter of substituting one type of device for another in accordance with a surgical procedure.
The combination of Shelton and Farago do not teach the device information including a material of a cutter of each atherectomy device, determine hardness of the lesion based on the target information, determine a grade of recommendation for each atherectomy device based on the determined hardness of the lesion and one or both of the rotation speed of the motor of each atherectomy device and the material of the cutter of each atherectomy device, wherein a higher grade is given to an atherectomy device with a motor having a rotation speed and a cutter having a material that are more suitable for cutting the lesion of the determined hardness and suitability of the atherectomy devices to lesions having different characteristics are updated based on prior treatments of the lesions by the atherectomy devices, or wherein the first screen includes information indicating the hardness of the lesion, a list of the atherectomy devices and the corresponding grades in a descending order of the grades, and a location of the lesion to be removed.
Regarding the device information indicating features of different types of atherectomy devices, the features including a material of a cutter of each atherectomy device, as Shelton teaches that the device information indicates the feature including the type of device, a device’s capacity for a procedure, and a device with a specific parameter set (Paragraphs 1536, 1543, 1555, and 1558), and as the material of a cutter for an atherectomy device determines the type of device and is a parameter, then it would be obvious to one of ordinary skill in the art that the controller of the combination can include the material of a cutter as a feature.
The combination of Shelton and Farago does not teach the controller configured to determine hardness of the lesion based on the target information, determine a grade of recommendation for each atherectomy device based on the determined hardness of the lesion and one or both of the rotation speed of the motor of each atherectomy device and the material of the cutter of each atherectomy device, wherein a higher grade is given to an atherectomy device with a motor having a rotation speed and a cutter having a material that are more suitable for cutting the lesion of the determined hardness and suitability of the atherectomy devices to lesions having different characteristics are updated based on prior treatments of the lesions by the atherectomy devices, or wherein the first screen includes information indicating the hardness of the lesion, a list of the atherectomy devices and the corresponding grades in a descending order of the grades, and a location of the lesion to be removed.
Rauniyar (Rauniyar et al.) teaches a medical system (100)(Figs. 1) comprising a display (10) and a controller (processing unit 50)(Paragraph 0033) connectable to treatment devices (62)(Paragraph 0038), wherein the controller is configured to acquire target information indicating characteristics of a target object to be removed (Paragraph 0038). Rauniyar further teaches wherein the target information includes a cross-sectional image of the target object (Paragraph 0049), and the controller is configured to: determine hardness of the target object based on the cross-sectional image and wherein the cross-sectional image is an ultrasound image (Paragraph 0012, 0038, 0039, 0049, and 0050).
It would have been obvious to one of ordinary skill in the art to modify the controller as taught by the combination to determine the hardness of the lesion based on the target information as taught by Rauniyar, since Rauniyar teaches that using this target information aids in allowing the surgeon to know the vasculature of the patient’s body (Paragraphs 0012 and 0050) and Shelton, IV teaches that the system is capable of determining tissue properties (Paragraph 1581 of Shelton, IV).
The combination of Shelton, Farago, and Rauniyar does not teach the controller configured to determine a grade of recommendation for each atherectomy device based on the determined hardness of the lesion and one or both of the rotation speed of the motor of each atherectomy device and the material of the cutter of each atherectomy device, wherein a higher grade is given to an atherectomy device with a motor having a rotation speed and a cutter having a material that are more suitable for cutting the lesion of the determined hardness and suitability of the atherectomy devices to lesions having different characteristics are updated based on prior treatments of the lesions by the atherectomy devices, or wherein the first screen includes information indicating the hardness of the lesion, a list of the atherectomy devices and the corresponding grades in a descending order of the grades, and a location of the lesion to be removed.
Megerian (Megerian et al.) teaches a system (100)(abstract) comprising a display (145) and a controller (processor 105) configured to acquire device information (Paragraph 0016), determine a grade of recommendation for medical operations, generate a screen that includes a list of the medical operations and the corresponding grades in a descending order of the grades (Paragraphs 0019 and 0021- 0026), and control the display to display the screen (Paragraphs 0016 and 0029- 0030).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the controller as taught by the combination to determine a grade of recommendation, generate a screen that includes ranking of each medical device, and display the screen as taught by Megerian, since Megerian teaches that this system accounts for particular attributes of respective medical perspectives and ranks medical operations accordingly and that it allows physicians to view the ranking of different treatment options (Paragraphs 0002 and 0009).
Regarding the controller determining a grade of recommendation for each atherectomy device based on the determined hardness of the lesion and one or both of the rotation speed of the motor of each atherectomy device and the material of the cutter of each atherectomy device, as Shelton teaches that the medical system provides a recommendation on a device for use during a procedure based on the data of the device and the location of the procedure within the body through a comparison of various devices as well as previous data from procedures (Paragraphs 1551 and 1552) and the combination teaches determining the hardness of the lesion (Paragraphs 0012, 0038, 0039, 0049, and 0050 of Rauniyar), it would have been obvious to one of ordinary skill in the art to modify the controller to grade a set of devices for completing the same medical procedure using the hardness of the lesion, the rotation speed of the motor, and the material of the cutter.
Regarding wherein a higher grade is given to an atherectomy device with a motor having a rotation speed and a cutter having a material that are more suitable for cutting the lesion of the determined hardness and suitability of the atherectomy devices to lesions having different characteristics are updated based on prior treatments of the lesions by the atherectomy devices, it would have been obvious to modify the controller to give a higher grade to an atherectomy device that is more suitable for cutting a lesion of a determined hardness based on prior treatments, since Shelton teaches that the controller provides a recommendation for the device that is best suited according to the anatomy and the data from previous procedures with the device (Paragraphs 1550, 1551, 1552,1554, and 1556) it would have been obvious to one of ordinary skill in the art to modify the ranking of devices to give a higher grade to an atherectomy device with a motor having a rotation speed and a cutter having a material more suitable for cutting the lesion of the determined hardness.
Regarding wherein the first screen includes information indicating the hardness of the lesion, a list of the atherectomy devices and the corresponding grades in a descending order of the grades, and a location of the lesion to be removed, as the system receives data about the target location (Paragraph 1558 of Shelton, IV) and the combination teaches determining the hardness of a lesion (Paragraph 0012, 0038, 0039, 0049, and 0050 of Rauniyar), it would have been obvious to display the information indicating the hardness of the lesion and the location of the lesion to be removed.
Regarding claims 2 and 12, Shelton, Farago, Rauniyar, and Megerian make obvious the medical system, including the devices being atherectomy devices, as discussed above.
As discussed above, it would have been obvious to have the devices of Shelton be atherectomy devices as taught by Farago since both Shelton and Farago teach that the medical systems are used in a surgical procedure (Shelton, Paragraph 0003; Farago, Paragraph 0003) and both teach that the surgical instruments are controlled by a controller (Shelton, Paragraph 1495; Farago, Paragraphs 0054 and 0058) and it would have been a matter of substituting one type of device for another in accordance with a surgical procedure.
The combination further teaches wherein each of the atherectomy devices (drive system 12)(Figs. 1-5) has a rotatable drive shaft (18), the motor configured to rotate the drive shaft (Paragraph 0048), and the cutter (rotatable device 20)(Paragraph 0047) attached to a distal end of the drive shaft (Paragraph 0052) and configured to cut the lesion when the drive shaft is rotated by the motor (Paragraph 0053).
Regarding claims 3, 4, 13, and 14, Shelton, Farago, Rauniyar, and Megerian make obvious the medical system, including the devices being atherectomy devices, as discussed above.
The combination does not make obvious (claims 3 and 13) wherein the target information includes a cross-sectional image of the lesion, and the controller is configured to: determine hardness of the lesion based on the cross-sectional image, and when the hardness exceeds a threshold, grade an atherectomy device having a motor that can rotate at a speed greater than a predetermined speed, higher than an atherectomy device having a motor that cannot rotate at a speed greater than the predetermined speed or (claims 4 and 14) wherein the cross-sectional image is an ultrasound image.
Rauniyar (Rauniyar et al.) teaches a medical system (100)(Figs. 1) comprising a display (10) and a controller (processing unit 50)(Paragraph 0033) connectable to treatment devices (62)(Paragraph 0038), wherein the controller is configured to acquire target information indicating characteristics of a target object to be removed (Paragraph 0038). Rauniyar further teaches wherein the target information includes a cross-sectional image of the target object (Paragraph 0049), and the controller is configured to: determine hardness of the target object based on the cross-sectional image and wherein the cross-sectional image is an ultrasound image (Paragraph 0012, 0038, 0039, 0049, and 0050).
It would have been obvious to one of ordinary skill in the art to modify the controller to acquire target information through an ultrasound image as taught by Rauniyar, since Rauniyar teaches that using this target information aids in determining the hardness of the target object and aids in allowing the surgeon to know the vasculature of the patient’s body (Paragraphs 0012 and 0050).
Regarding when the hardness exceeds a threshold, rank an atherectomy device having a motor that can rotate at a speed greater than a predetermined speed, higher than an atherectomy device having a motor that cannot rotate at a speed greater than the predetermined speed, the combination does not teach these limitations. However, since Shelton teaches that the medical system provides a recommendation on a device to use for a procedure based on data of the device and the location of the procedure and through comparison (Paragraphs 1551 and 1552) and Rauniyar teaches that the controller is able to determine the hardness of an object with a cross-sectional image (Paragraph 0012), it would have been obvious to one of ordinary skill in the art to modify the controller to measure the hardness of an object and then compare the atherectomy devices according to their rotation speeds to determine which one ranks higher.
Regarding claims 9 and 19, Shelton, Farago, Rauniyar, and Megerian make obvious the medical system, including the devices being atherectomy devices, as discussed above.
As discussed above, it would have been obvious to have the devices of Shelton be atherectomy devices as taught by Farago since both Shelton and Farago teach that the medical systems are used in a surgical procedure (Shelton, Paragraph 0003; Farago, Paragraph 0003) and both teach that the surgical instruments are controlled by a controller (Shelton, Paragraph 1495; Farago, Paragraphs 0054 and 0058) and it would have been a matter of substituting one type of device for another in accordance with a surgical procedure.
The combination further teaches wherein the drive device (Farago, motor 37) is configured to hold and control an atherectomy device (Farago, rotational device 20) connected to the medical device (Farago, advancer assembly 16, drive shaft 18, and an elongated member 22)(As Farago teaches that the rotational device 20 is in communication with the motor 37 through the drive shaft (Paragraph 0059), which is taught to be connected with the rotational device, then the motor controls the first device. Furthermore, as the motor is coupled with the drive shaft which is coupled with the rotational device (Paragraph 0053), the motor holds the rotational device through the coupling from the drive shaft.).
Regarding wherein the controller is configured to detect a selection of one of the atherectomy devices listed on the display, in Paragraph 1561, Shelton teaches that the controller is able to detect the device and monitor the procedure of a surgeon. Therefore, the controller is able to detect a selection of a device on the display and in the combination the device would be able to detect a selected listed on the display.
The combination does not teach wherein the controller is configured to determine a holding force for holding the selected atherectomy device by the drive device.
Farago teaches a medical system (atherectomy system 10)(Figs. 1-5)(abstract) comprising a display (30), a processor (Paragraph 0057) and a controller (control unit 14) connectable to a drive device (motor 37) configured to control a medical device (advancer assembly 16, derive shaft 18, and an elongated member 22) operated by an operator to remove the object (Paragraphs 0047, 0058, and 0059), wherein the controller is configured to acquire target information indicating characteristics of a target object to be removed (Paragraphs 0068 and 0071) and wherein the controller is configured to determine an appropriate torque from the motor for operating the device (Paragraph 0075 and 0076)(As the torque affects both the drive shaft 18 and the rotational device 20 when created by the motor, that force affects the coupling of the shaft and the device and therefore if the force exceeds an appropriate torque the coupling of the shaft and the device can come undone or be damaged. Therefore, the controller determines an appropriate holding force. Furthermore, as this language is functional, and the controller of Farago is able to calculate torque, the controller of Farago would be able to calculate an appropriate holding force.).
It would have been obvious to one of ordinary skill to modify the controller to be configured to determine a holding force for holding the selected first device by the drive device, since Farago teaches that calculating the force prevents the device from injuring the patient (Paragraph 0072).
Regarding wherein the controller is configured display information about the holding force on the display, as Shelton teaches that a recommendation is displayed on a graphical display to the surgeon (Paragraph 1555), after calculating the holding force, the controller is able to display that information on the display.
Regarding claim 10, Shelton, Farago, Rauniyar, and Megerian make obvious the medical system, including the devices being atherectomy devices, as discussed above.
Shelton further teaches wherein the target information further indicates characteristics of the lesion before a treatment that has been previously performed (Paragraphs 1551 and 1552).
Regarding claim 21, Shelton, Farago, Rauniyar, and Megerian make obvious the medical system, including the devices being atherectomy devices, as discussed above.
As discussed above, it would have been obvious to have the devices of Shelton be atherectomy devices as taught by Farago since both Shelton and Farago teach that the medical systems are used in a surgical procedure (Shelton, Paragraph 0003; Farago, Paragraph 0003) and both teach that the surgical instruments are controlled by a controller (Shelton, Paragraph 1495; Farago, Paragraphs 0054 and 0058) and it would have been a matter of substituting one type of device for another in accordance with a surgical procedure. It would have been obvious to display a list of the first devices according to the grade and information indicating the hardness of the lesion, as Shelton teaches displaying the recommendation on a display (Paragraphs 1555 and 1556) and as the system receives data about the target location (Paragraph 1558).
Regarding wherein the controller is configured to upon selection of one of the atherectomy devices on the first screen, determine a grade of recommendation for different treatment methods to remove the lesion using said one of the atherectomy device based on the target information, as Shelton teaches that procedure can involve multiple steps and procedures with devices (Paragraph 0870), that the controller is able to keep track of the order of the procedure (Paragraph 1561) and that the medical system provides a recommendation on a device to use for a procedure based on data of the device and the location of the procedure and through comparison (Paragraphs 1551 and 1552), it would have been obvious to one of ordinary skill in the art to modify the controller to, determine a grade of recommendation for different treatment methods to remove a lesion.
Regarding the controller being configured to generate a second screen including: information indicating the hardness of the lesion, information indicating said one of the atherectomy devices, a list of the treatment methods and the corresponding grades in a descending order of the grades, and a location of the lesion to be removed and control the display to display the second screen as Shelton teaches displaying the recommendation on a display (Paragraphs 1555 and 1556) and as the system receives data about the target location (Paragraph 1558), it would have been obvious to generate a second screen information indicating one of the atherectomy devices and a list of the treatment methods, the location of the lesion and the hardness of the lesion.
Claim(s) 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, IV et al. (US 2019/0125458) in view of Farago et al. (US 2019/0209204), in view of Rauniyar et al. (US 2018/0325619) and in view of Megerian et al. (US 2020/0273571), as applied to claims 2 and 12 above, in further view of Kadavy et al. (US 6,443,967).
Regarding claims 5 and 15, Shelton, Farago, Rauniyar, and Megerian make obvious the medical system, including the first devices being atherectomy devices, as discussed above.
The combination does not teach wherein the target information includes a cross- sectional image of the lesion to be removed, and the controller is configured to: determine hardness of the lesion based on the cross- sectional image, and when the hardness exceeds a threshold, grade an atherectomy device having a diamond- coated cutter higher than an atherectomy device not having a diamond- coated cutter.
Rauniyar (Rauniyar et al.) teaches a medical system (100)(Figs. 1) comprising a display (10) and a controller (processing unit 50)(Paragraph 0033) connectable to treatment devices (62)(Paragraph 0038), wherein the controller is configured to acquire target information indicating characteristics of a target object to be removed (Paragraph 0038). Rauniyar further teaches wherein the target information includes a cross-sectional image of the target object (Paragraph 0049), and the controller is configured to: determine hardness of the target object based on the cross-sectional image and wherein the cross-sectional image is an ultrasound image (Paragraph 0012, 0038, 0039, 0049, and 0050).
It would have been obvious to one of ordinary skill in the art to modify the controller to acquire target information through an ultrasound image as taught by Rauniyar, since Rauniyar teaches that using this target information aids in determining the hardness of the target object and aids in allowing the surgeon to know the vasculature of the patient’s body (Paragraphs 0012 and 0050).
The combination does not make obvious wherein the controller is configured to when the hardness exceeds a threshold, grade an atherectomy device having a diamond- coated cutter higher than an atherectomy device not having a diamond- coated cutter.
Kadavy (Kadavy et al.) teaches a medical system (abstract)(Fig. 1) with an atherectomy device (cutting tool 12, driveshaft 14) having a diamond- coated cutter (cutting tool 12)(Column 2, Lien 64- Column 3, Line 6).
It would have been obvious to one of ordinary skill in the art to have one of the atherectomy devices be a diamond- coated cutter as taught by Kadavy, since Kadavy teaches that the diamond- coated cutter transfers heat away from an ablation site and therefore reduces the likelihood of thermal damage as a result of the procedure (Column 3, Lines 1- 6).
Furthermore, it would have been obvious to modify the controller to grade an atherectomy device with a diamond- coated cutter higher than an atherectomy device since Kadavy teaches that the diamond- coated cutter transfers heat away from an ablation site and therefore reduces the likelihood of thermal damage as a result of the procedure (Column 3, Lines 1- 6) and Shelton teaches that the controller uses data from previous operations and data from the medical field to determine a recommendation for a device for a surgery (Paragraph 1500).
Claim(s) 6- 8 and 16- 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, IV et al. (US 2019/0125458) in view of Farago et al. (US 2019/0209204), in view of Rauniyar et al. (US 2018/0325619) and in view of Megerian et al. (US 2020/0273571), as applied to claims 2 and 12 above, in further view of Wallace (US 2016/0367275).
Regarding claims 6 and 16, Shelton, Farago, Rauniyar, and Megerian make obvious the medical system, including the first devices being atherectomy devices, as discussed above.
Shelton further teaches that a procedure can involve multiple steps and procedures with devices (Paragraph 0870).
The combinations does not teach wherein the device information indicates features of different types of access devices by which each of the atherectomy devices is guided toward the lesion in the blood vessel, and the controller is configured to: grade the access devices using the device information and the target information, and display on the display a list of the access devices according to the grade thereof.
Wallace teaches a medical system (abstract) featuring a first device as an atherectomy device (Paragraph 0019), a second device as a guide for a treatment device towards a target object (Paragraph 0020), and a third device that is the treatment device and is introduced after the atherectomy device (Paragraph 0021).
It would have been obvious to one of ordinary skill in the art to have second devices that guide the atherectomy device of the combination as taught by Wallace, since introduction devices are well-known in the art to aid a surgeon in introducing a device (Wallace 0032) and Shelton teaches that an access device can be used in a procedure (Paragraph 0539).
The combination of Shelton, Farago, and Wallace does not teach grading the access device for removing the lesion using the device information and the target information.
However, since Wallace teaches multiple devices for introducing a catheter (Paragraph 0020) and Shelton teaches that the medical system provides a recommendation on a device to use for a procedure based on data of the device and the location of the procedure and through comparison (Paragraphs 1551 and 1552), it would have been obvious to one of ordinary skill in the art to modify the controller to grade the access devices using the device information and target information. Furthermore, since Shelton teaches displaying the recommendation on a display (Paragraph 1555), it would have been obvious to display a list of the access devices according to the grade.
Regarding claims 7 and 17, Shelton, Farago, Rauniyar, Megerian, and Wallace make obvious the medical system, including the first devices being atherectomy devices, as discussed above.
As discussed above, Shelton further teaches that a procedure can involve multiple steps and procedures with devices (Paragraph 0870).
The combination does not teach wherein the device information indicates features of different types of treatment devices for treating the blood vessel from which the lesion has been removed, and the controller is configured to: grade the treatment devices using the device information and the target information, and display on the display a list of the treatment devices according to the grade thereof.
Wallace teaches a medical system (abstract) featuring a first device as an atherectomy device (Paragraph 0019), a second device as a guide for a treatment device towards a target object (Paragraph 0020), and a third device that is the treatment device and is introduced after the atherectomy device (Paragraph 0021).
It would have been obvious to one of ordinary skill in the art to have a set of treatment devices that treat the body cavity as taught by Wallace, since Wallace teaches that the treatment prevents restenosis after use of an atherectomy device (Paragraphs 0021 and 0043).
The combination does not teach wherein the controller is configured to: grade the treatment devices using the device information and the target information, and display on the display a list of the treatment devices according to the grade thereof.
However, Shelton teaches that the medical system provides a recommendation on a device to use for a procedure based on data of the device and the location of the procedure and through comparison (Paragraphs 1551 and 1552), it would have been obvious to one of ordinary skill in the art to modify the controller to grade the treatment devices using the device information and target information. Furthermore, since Shelton teaches displaying the recommendation on a display (Paragraph 1555), it would have been obvious to display a list of the treatment devices according to the grade.
Regarding claims 8 and 18, Shelton, Farago, Rauniyar, Megerian, and Wallace make obvious the medical system, including the first devices being atherectomy devices, as discussed above.
Regarding wherein the controller displays on the display the lists of the atherectomy devices, the access devices, and the treatment devices on different screens in this order, as Shelton teaches that a procedure has multiple devices and steps (Paragraph 0870), it would be obvious that at each step of a procedure, with an access device, then the atherectomy device, and finally the treatment device, that the display provides the list of each device on different screens as the procedure continues.
Response to Arguments
Applicant’s arguments, see Pages 9-14, filed February 19th, 2026, with respect to the rejections of claims 1-19 and 21 have been fully considered and are persuasive. The rejection of claims 1-19 and 21 has been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771