DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the set of claims received on 08 November 2024. Claims 1-20 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Note: As the prior-filed applications do not provide support for the use of a “fiducial,” the current application is being examined using an effective filing date of 08 November 2024.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the fiducial (i.e. initially recited in claims 1 and 17), and plate/anchor (i.e. recited in claims 5 and 9) must be shown or the features canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informality:
In lines 5-6, it appears that the phrase “configured to perform a method” should read “configured to perform functions” for clarity.
Claim 6 is objected to because of the following informality:
In line 1, it appears that the phrase “where the fiducial” should read “wherein the fiducial” for consistency.
Claim 9 is objected to because of the following informality:
In line 1, it appears that the phrase “bar code the encodes” should read “bar code that encodes.”
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 1-13, 15-17 and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (i.e. a mental process) without significantly more.
Claims 1-13, 15-17 and 19-20 are directed toward a system/method for modifying a 3D model of an area of anatomic interest (i.e. a machine/process). Hence, the claims are directed to one of the four statutory categories (i.e. process, machine, manufacture, or composition of matter) (STEP 1: YES).
However, claims that fall within one of the four subject matter categories may nevertheless be ineligible if they encompass laws of nature, physical phenomena, or abstract ideas (see Diamond v. Chakrabarty, 447 U.S. 309 (1980)).
The representative claims recite the following:
Independent claim 1 is directed to “a system for modifying a 3D model of an area of anatomic interest, the system comprising a fiducial that is attached to a bone surface in the area of anatomic interest; an intra-operative three-dimensional (3D) scanner; and a computer that is connected to the intra-operative 3D scanner and that is configured to perform a method comprising: receiving, from the intra-operative 3D scanner, scan data from an intra-operative scan of the bone surface, wherein the scan data includes data representing the fiducial; generating, from the scan data, an intra-operative 3D model that includes a 3D representation of the fiducial; registering the intra-operative 3D model with a pre-operative 3D model of the area of anatomic interest; modifying the pre-operative 3D model to include the fiducial at a location according to the intra-operative 3D model; and providing the modified pre-operative 3D model to a surgical navigation system that tracks objects in the area of anatomic interest based on the location of the fiducial.”
Independent claim 17 is directed to “a computer-implemented method for modifying a 3D model of an area of anatomic interest using an intra-operative 3D scanner, the method comprising receiving, from the intra-operative 3D scanner, scan data from an intra-operative scan of a bone surface in the area of anatomic interest, wherein the scan data includes data representing a fiducial; generating, from the scan data, an intra-operative 3D model that includes a 3D representation of the fiducial; registering the intra-operative 3D model with a pre-operative 3D model of the area of anatomic interest; modifying the pre-operative 3D model to include the fiducial at a location according to the intra-operative 3D model; and providing the modified pre-operative 3D model to a surgical navigation system that tracks objects in the area of anatomic interest based on the location of the fiducial.”
The underlined portions of the claims recite an abstract idea because each portion includes one or more mental processes (e.g., observations, evaluations, and/or judgments) that can be performed in the mind or with the aid of pen and paper. (STEP 2A, PRONG 1: YES. The claimed invention recites an abstract idea.).
This judicial exception is not integrated into a practical application because the claims (i.e. at least claims 1 and 17) recite generic steps of receiving data, generating a model, registering the model, modifying the model, and providing the model without adding meaningful limitations to the system for surgery without using optical trackers. Additional claims (i.e. claims 2-13, 15-16, and 19-20) further define the abstract idea (e.g. identifying a landmark, analyzing the model, and combining models). The instant claims do no actually provide any surgical intervention, but rather they provide for planning such a procedure.
The claims recite the additional elements of a fiducial (e.g. plate/anchor), an intra-operative 3D scanner (e.g. handheld laser 3D scanner), a computer, and a surgical navigation system (i.e. claims 1-13, 15-17 and 19-20) including functional language related thereto (e.g. to perform a method...tracking objects, and encoding surgery-assisting information). The additional elements are not sufficient to amount to significantly more than the judicial exception because they do not (1) improve the functioning of a computer or other technology, (2) are not applied with any particular machine, (3) do not effect a transformation of a particular article to a different state, (4) do not effect a particular treatment or prophylaxis for a disease or medical condition, and (5) are not applied in any meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claimed invention, as a whole, is more than a drafting effort designed to monopolize the exception (see MPEP §§ 2106.04(d)-(d)(2) and 2106.05(a)-(c), (e)-(h)). Therefore, the claims are directed to the judicially recognized exception of an abstract idea. (STEP 2A, PRONG 2: NO. The claimed invention is directed to an abstract idea.)
The claims encompass the following additional element in the claims other than the abstract idea per se: a computer. Viewed as a whole, this additional claim element does not provide meaningful limitation(s) to transform the abstract idea into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself.
The above-identified additional elements (e.g. a computer) is a generically claimed computer which enable the above-identified abstract idea 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:
[0023] Referring to both Figures 1A and 1D, the computer 150 can be any device capable of receiving input, performing calculations based on the input, and producing output as a result of the calculations. The computer 150 may include a central processor 102 that is capable of interacting with a user via a keyboard, a graphical user interface, wireless communication, voice command, or any other manner. The computer 150 may be a personal computer, a laptop, a handheld device, a server, a network of servers, a cloud network, or the like. The user, such as a surgeon or surgeon’s assistant, may interact with the computer 150 before, during, or after the surgical procedure. The computer 150 may include a memory 104 or may be otherwise communicatively coupled to a memory that contains various software applications 106 for performing calculations, and executing algorithms, routines, and/or subroutines, for example, to process information and/or make determinations. For example, the computer 150 may include one or more software applications configured to analyze information (e.g. scan data) obtained from 3D scanner 110, generate a 3D model or 3D scan image, and analyze the 3D model. In one example, software applications 106 include an object recognition module 108 configured to recognize various objects or features in an image, such as the 3D scanned image. Facial recognition, fingerprint recognition, and iris recognition software systems are examples of object recognition technology. Each of these software systems make comparisons of anatomical features of an image with features in a database that is either stored in the computer 150 or is accessible by the computer by wired or wireless connection. The computer 150 may further include a robotics control module 109 for controlling and communicating with the robotics unit 160. The computer 150 may further include other optional modules, such as an artificial intelligence or also referred to herein as a machine learning module 112 that are configured to apply one or more machine learning algorithms to identify anatomical landmarks of interest, among other functions.
Accordingly, in light of Applicant’s specification, the claimed term “computer” 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 this limitation requires 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 processor. 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 use of a fiducial (i.e. claims 1-13, 15-17 and 19-20), an intra-operative 3D scanner (i.e. claims 1-13, 15-17 and 19-20), and a surgical navigation system (i.e. claims 1-13, 15-17 and 19-20) does not amount to significantly more, and is well-understood, routine, and conventional. The dependent claims 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.
The recitation of the above-identified additional limitations in claims 1-13, 15-17 and 19-20 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/generate/provide/output/ 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.
Taking the claimed elements individually yields no difference from taking them in combination because each element simply performs its respective function as discussed above. The claims do not purport to improve the functioning of a computer itself, nor do they effect an improvement in any other technology or technical field. Instead, the additional features merely amount to an instruction to apply the abstract idea using generic, functional, and conventional components well-known in the art. Viewed as a whole, these additional claim 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. (STEP 2B: NO. The claimed invention does not add significantly more and is not eligible subject matter.)
Therefore, claims 1-13, 15-17 and 19-20 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter (see Alice Corporation Pty. Ltd. v. CLS Bank International, et al., 573 U.S. 208 (2014)).
Note: It appears that amending the independent claims to include, for example, “guiding a surgical tool, based on the modified 3D model, to perform an act including at least one of: (a) cutting bone and (b) placing a suture” (see paragraph 0029 of the current specification for support) would add significantly more and overcome the rejections under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 Lang (U.S. Patent Application Publication 2020/0138518). Regarding claims 1-16, Lang discloses (as to claim 1) a system (see Figures 1-40D) capable of modifying a 3D model of an area of anatomic interest (e.g. femur, tibia, pelvis, and humerus), the system comprising a fiducial (e.g. 51, 420, and 425) that is capable of being attached to a bone surface in the area of anatomic interest; an intra-operative three-dimensional (3D) scanner (i.e. used at step 143, see paragraph 1068); and a computer (see paragraph 1065) that is capable of being connected to the intra-operative 3D scanner and that is configured to perform functions comprising receiving, from the intra-operative 3D scanner, scan data from an intra-operative scan of the bone surface (see paragraph 1068), wherein the scan data in capable of including data representing the fiducial (see paragraphs 1061-1064); generating, from the scan data, an intra-operative 3D model (see paragraph 1183) that is capable of including a 3D representation of the fiducial (see paragraphs 1352 and 1683); registering the intra-operative 3D model with a pre-operative 3D model of the area of anatomic interest (see paragraphs 1685-1688); modifying the pre-operative 3D model to include the fiducial at a location according to the intra-operative 3D model see paragraphs 1618 and 1683); and providing the modified pre-operative 3D model to a surgical navigation system that tracks objects in the area of anatomic interest based on the location of the fiducial (see paragraph 1406), wherein (as to claim 2) the intra-operative 3D scanner is a handheld laser 3D scanner (e.g. Structure laser scanner, see paragraph 1186), wherein (as to claim 3) the pre-operative 3D model is created from MRI scan data (see paragraph 0236), wherein (as to claim 4) the method further comprises employing a machine learning model to identify an anatomical landmark in the intra-operative 3D model (see paragraphs 0264, 0266 and 0325), wherein (as to claim 5) the fiducial is a plate or an anchor (see paragraph 1683), wherein (as to claim 6) the fiducial is attached to the bone surface at a predetermined location (see paragraphs 0358 and 1057), wherein (as to claim 7) the predetermined location is capable of being based on a preoperative image of the bone surface (see paragraphs 0358 and 1057), wherein (as to claim 8) the preoperative image is at least one of: a computer tomography image, an ultrasound image, or a magnetic resonance image (see paragraph 0236), wherein (as to claim 9) the plate includes a bar code the encodes surgery-assisting information (see paragraph 0388), wherein (as to claim 10) the method further comprises analyzing the intra-operative 3D model to differentiate between different types of tissue (see paragraphs 0302-0304), wherein (as to claim 11) the analyzing employs machine learning methods (see paragraphs 0264, 0266 and 0325), wherein (as to claim 12) the different types of tissue include bone tissue and cartilage tissue (see paragraphs 0302-0304), wherein (as to claim 13) the fiducial is attached intra-operatively without using a predetermined location on the bone surface (see paragraph 0417 referring to determining a location of a fiducial); and the method further comprises: analyzing the intra-operative 3D model to detect the location of the fiducial (see paragraph 0264, 0387, 0405, 0409-0410, and 0422), wherein (as to claim 14) registering the intra-operative 3D model with a pre-operative 3D model comprises: aligning the intra-operative 3D model with the pre-operative 3D model using an iterative closest point (ICP) algorithm (see paragraphs 0256, 0266, 1627, and 1688), wherein (as to claim 15) modifying the pre-operative 3D model to include the fiducial at a location according to the intra-operative 3D model comprises: combining the intra-operative 3D model with the pre-operative 3D model to produce the modified pre-operative 3D model (see paragraphs 1193 and 1196), and wherein (as to claim 16) the modified pre-operative 3D model is capable of including the fiducial from the intra-operative 3D model (i.e. due to it still being present during the operation) (see Figures 1-40D, and paragraphs 0236, 0256, 0264, 0266, 0302-0304, 0325, 0358, 0387-0388, 0405, 0409-0410, 0417, 0422, 0509, 1057, 1061-1065, 1068, 1183, 1186, 1193, 1196, 1352, 1406, 1618, 1627, 1683, and 1685-1688; however, the entirety of the disclosure applies).
Regarding claims 17-20, Lang discloses (as to claim 17) a computer-implemented method for modifying a 3D model of an area of anatomic interest (e.g. femur, tibia, pelvis, and humerus) using an intra-operative three-dimensional (3D) scanner (i.e. used at step 143, see paragraph 1068), the method comprising receiving, from the intra-operative 3D scanner, scan data from an intra-operative scan of the bone surface (see paragraph 1068), wherein the scan data in capable of including data representing the fiducial (see paragraphs 1061-1064); generating, from the scan data, an intra-operative 3D model (see paragraph 1183) that is capable of including a 3D representation of the fiducial (see paragraphs 1352 and 1683); registering the intra-operative 3D model with a pre-operative 3D model of the area of anatomic interest (see paragraphs 1685-1688); modifying the pre-operative 3D model to include the fiducial at a location according to the intra-operative 3D model see paragraphs 1618 and 1683); and providing the modified pre-operative 3D model to a surgical navigation system that tracks objects in the area of anatomic interest based on the location of the fiducial (see paragraph 1406), wherein (as to claim 18) registering the intra-operative 3D model with a pre-operative 3D model comprises: aligning the intra-operative 3D model with the pre-operative 3D model using an iterative closest point (ICP) algorithm (see paragraphs 0256, 0266, 1627, and 1688), wherein (as to claim 19) modifying the pre-operative 3D model to include the fiducial at a location according to the intra-operative 3D model comprises: combining the intra-operative 3D model with the pre-operative 3D model to produce the modified pre-operative 3D model (see paragraphs 1193 and 1196), and wherein (as to claim 20) the modified pre-operative 3D model is capable of including the fiducial from the intra-operative 3D model (i.e. due to it still being present during the operation) (see Figures 1-40D, and paragraphs 0236, 0256, 0264, 0266, 0302-0304, 0325, 0358, 0387-0388, 0405, 0409-0410, 0417, 0422, 0509, 1057, 1061-1065, 1068, 1183, 1186, 1193, 1196, 1352, 1406, 1618, 1627, 1683, and 1685-1688; however, the entirety of the disclosure applies).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
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