DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a method without significantly more. The claim(s) recite(s) a method of accessing a plan, generate a map for a trajectory to generate a surgical plan. This judicial exception is not integrated into a practical application because the claim is directed to an abstract idea with additional generic computer elements, wherein computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception. the additional limitations only store and retrieve information in a well-understood, routine, conventional manner through a computer function as recognized by the court decisions listed in MPEP § 2106.05(d)
Claims 1-20 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) without significantly more.
Each of Claims 1-20 has been analyzed to determine whether it is directed to any judicial exceptions.
Each of Claims 1-20 recites at least one step or instruction for accessing a plan, generate a map for a trajectory to generate a surgical plan using a processor as a tool or aid, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. The claimed limitations involve managing interactions between people, namely, humans following rules, which is one of certain methods of organizing human activity under the 2019 PEG.]] Accordingly, each of Claims 1-20 recites an abstract idea.
Specifically, claim 1 recites:
A method comprising: accessing surgical plans for previous stereotactic procedures performed on a group of patients, the surgical plans including imaging data representing an anatomical feature of each patient in the group; applying one or more transforms to register the imaging data for each patient to a template of the anatomical feature for the group of patients; generating one or more density maps for a trajectory targeting at least one region of interest (ROI) in the anatomical feature, based on the registered imaging data; and generating a surgical plan to perform a current stereotactic procedure on a subject patient, based on the one or more density maps, the surgical plan including the trajectory targeting the at least one ROI in the anatomical feature of the subject patient.
Specifically, claim 11 recites:
11. A system comprising: a processor; and a memory coupled to the processor, the memory storing instructions that, when executed by the processor, cause the processor to perform operations including: accessing surgical plans for previous stereotactic procedures performed on a group of patients, the surgical plans including imaging data representing an anatomical feature of each patient in the group; applying one or more transforms to register the imaging data for each patient to a template of the anatomical feature for the group of patients; generating one or more density maps for a trajectory targeting at least one region of interest (ROI) in the anatomical feature, based on the registered imaging data; and generating a surgical plan to perform a current stereotactic procedure on a subject patient, based on the one or more density maps, the surgical plan including the trajectory targeting the at least one ROI in the anatomical feature of the subject patient.
Specifically, claim 19 recites:
19. A surgical robot comprising: a robotic arm including a surgical tool for performing a stereotactic procedure on a subject patient; and a control unit to perform a plurality of operations, the plurality of operations including: accessing surgical plans for previous stereotactic procedures performed on a group of patients, the surgical plans including imaging data representing an anatomical feature of each patient in the group; applying one or more transforms to register the imaging data for each patient to a template of the anatomical feature for the group of patients; generating a density map of trajectory points for a trajectory of the robotic arm targeting at least one region of interest (ROI) in the anatomical feature, based on the registered imaging data; and generating a surgical plan to perform a current stereotactic procedure on the subject patient, based on the density map, the surgical plan including the trajectory of the robotic arm targeting the at least one ROI in the anatomical feature of the subject patient.
The steps of accessing surgical plans, generating a density map of trajectory points for a trajectory and; generating a surgical plan are considered as steps that can be performed by observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG).
Also, it involves managing interactions between people, namely, humans following rules, which is grouped as a certain method of organizing human activity under 2019 PEG and/or a judgement or evaluation, which is grouped as a mental process under 2019 PEG);
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 2-10, 12-18 and 20 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 process steps are performed.
The above-identified abstract idea in each of independent Claims 1, 11 and 19 (and their respective dependent Claims 2-10, 12-18 and 20) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1, 11 and 19), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: a processor, and a control unit as recited in independent claims 1, 11 and 19 and its dependent claims; are generically recited computer elements in independent Claims 1, 11 and 19 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation 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. 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. For at least these reasons, the abstract idea identified above in independent Claims 1, 11 and 19 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG 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., a processor, and a control unit 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. 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. 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, 11 and 19 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1, 11 and 19 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
None of Claims 1-20 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
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, 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, as discussed in paragraphs 0028 and 0048-0050, specification discusses the computer, and a controller, are generically described without structure or detailed drawings, e.g., schematic drawing or described as an iphone or ipad or mobile device or personal computer or laptop. Therefore, the computer, and a controller are well understood, routine and conventional.
Accordingly, in light of Applicant’s specification, the claimed term the computer, and a controller are 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.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the computer, and a 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 Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-20 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 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. 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, 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 apparatus, systems and method of Claims 1-20 are directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general-purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of Claims 1-20 provide 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.
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, 11 and 19 (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. That is, 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. 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. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, 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. Thus, claims 1-20 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-20 amounts to significantly more than the abstract idea itself.
Accordingly, claims 1-20 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braido et al. (US 2023/0157762 A1).
With respect to claim 1, Braido discloses a method comprising: accessing surgical plans for previous stereotactic procedures performed on a group of patients, the surgical plans including imaging data representing an anatomical feature of each patient in the group (see paragraphs 0102-0105); applying one or more transforms to register the imaging data for each patient to a template of the anatomical feature for the group of patients (see paragraphs 0112 and 0175); generating one or more density maps for a trajectory targeting at least one region of interest (ROI) in the anatomical feature, based on the registered imaging data (see paragraphs 0050, 0069, 0103 and 0135); and generating a surgical plan to perform a current stereotactic procedure on a subject patient, based on the one or more density maps, the surgical plan including the trajectory targeting the at least one ROI in the anatomical feature of the subject patient (see paragraphs 0102-0105).
With respect to claims 2 and 12, Braido discloses the current stereotactic procedure is a neurosurgical stereotactic procedure (see paragraphs 0050 and 0060).
With respect to claims 3 and 13, Braido discloses the surgical plans further include: information identifying a plurality of targeted regions in the anatomical feature for the group of patients; and coordinates of the trajectory for each targeted region of the plurality of targeted regions in a three-dimensional (3D) space, and wherein the at least one ROI is selected from among the plurality of targeted regions (see paragraphs 0024 and 0050).
With respect to claims 4 and 14, Braido discloses the trajectory includes an entry point and a target point for each targeted region of the plurality of targeted regions (see paragraphs 0024 and 0050).
With respect to claims 5 and 15, Braido discloses applying the one or more transforms comprises: calculating a first transform to register the imaging data for each patient in the group to the template of the anatomical feature (see paragraphs 0102-0105); and applying the first transform to register the coordinates of the respective entry and target points for each targeted region from a first native space associated with each patient in the group to a template space associated with the template of the anatomical feature (see paragraphs 0112, 0130 and 0175).
With respect to claims 6 and 16, Braido discloses generating the surgical plan comprises: calculating a second transform to register an image of the anatomical feature of the subject patient to the template; applying an inverse of the second transform to map the registered coordinates of the respective entry and target points for the at least one ROI to the anatomical feature of the subject patient in a second native space (see paragraph 0050); and generating the surgical plan for the subject patient, based on the entry and target points for at least one ROI mapped to the anatomical feature of the subject patient in the second native space (see paragraphs 0102-0105).
With respect to claim 7, Braido discloses the one or more density maps for each targeted region include distributions of the corresponding entry and target points in the template space (see paragraphs 0024 and 0050).
With respect to claim 8, Braido discloses generating the one or more density maps further comprises: calculating the coordinates of the respective entry and target points for each targeted region in the template space based on the corresponding distributions (see paragraphs 0024 and 0050).
With respect to claims 9 and 17, Braido discloses the current stereotactic procedure is performed using a robotic surgical tool attached to a robotic arm of a surgical robot, and where the method further comprises: controlling the robotic arm of the surgical robot to perform the current stereotactic procedure on the subject patient according to the surgical plan (see paragraphs 0012 and 0064; see Figures 6M and 6N).
With respect to claims 10 and 18, Braido discloses each of the one or more density maps includes a distribution of each trajectory point associated with the trajectory of the robotic arm in a three-dimensional (3D) template space representing the anatomical feature, and wherein controlling the robotic arm comprises: controlling a position of the robotic arm during the current stereotactic procedure according to the distribution of each trajectory point associated with the trajectory of the robotic arm in the 3D template space (see paragraphs 0050, and 0070).
With respect to claim 11, Braido discloses a system comprising (see Figure 1): a processor (see computer #105a and #105b); and a memory coupled to the processor, the memory storing instructions that, when executed by the processor, cause the processor to perform operations including (see paragraphs 0057 and 0179): accessing surgical plans for previous stereotactic procedures performed on a group of patients, the surgical plans including imaging data representing an anatomical feature of each patient in the group (see paragraphs 0102-0105); applying one or more transforms to register the imaging data for each patient to a template of the anatomical feature for the group of patients (see paragraphs 0112 and 0175); generating one or more density maps for a trajectory targeting at least one region of interest (ROI) in the anatomical feature, based on the registered imaging data (see paragraphs 0050, 0069, 0103 and 0135); and generating a surgical plan to perform a current stereotactic procedure on a subject patient, based on the one or more density maps, the surgical plan including the trajectory targeting the at least one ROI in the anatomical feature of the subject patient (see paragraphs 0102-0105).
With respect to claim 19, Braido discloses a surgical robot comprising: a robotic arm including a surgical tool for performing a stereotactic procedure on a subject patient (see paragraphs 0012 and 0064; see Figures 6M and 6N); and a control unit to perform a plurality of operations, the plurality of operations including (see paragraph 0070): accessing surgical plans for previous stereotactic procedures performed on a group of patients, the surgical plans including imaging data representing an anatomical feature of each patient in the group (see paragraphs 0102-0105); applying one or more transforms to register the imaging data for each patient to a template of the anatomical feature for the group of patients (see paragraphs 0112 and 0175); generating a density map of trajectory points for a trajectory of the robotic arm targeting at least one region of interest (ROI) in the anatomical feature, based on the registered imaging data (see paragraphs 0050, 0069, 0103 and 0135); and generating a surgical plan to perform a current stereotactic procedure on the subject patient, based on the density map (see paragraphs 0102-0105), the surgical plan including the trajectory of the robotic arm targeting the at least one ROI in the anatomical feature of the subject patient (see paragraphs 0012 and 0064; see Figures 6M and 6N).
With respect to claim 20, Braido discloses the operations further include: controlling the robotic arm to perform the current stereotactic procedure on the subject patient (see paragraphs 0050 and 0060) according to the surgical plan (see paragraphs 0012 and 0064; see Figures 6M and 6N).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional prior art cited in the PTO 892 not relied upon discloses a system to manage a robotic device for medical purposes.
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/DIXOMARA VARGAS/Primary Examiner, Art Unit 3798
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