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 .
A preliminary amendment has been received on 11/05/2024. Claim 1-12 have been canceled and claims 13-24 have been newly added. Therefore, claims 13-24 remain pending in this application.
Claims 13-24 have been examined.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 13-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 13-23 are drawn to a system which is within the four statutory categories (i.e. machine). Claim 24 is drawn to a method which is within the four statutory categories (i.e. process).
Step 2A, Prong 1:
Claims 13 and 24 recite:
“detecting patient-specific kinematic data and patient data;
enriching the patient-specific kinematic data with comparative data to generate enriched patient-specific kinematic data, the comparative data comprising historical data similar to the patient-specific kinematic data based on older or earlier insertions of the implant system;
determining a phenotype of the patient based on the patient-specific kinematic data;
performing planning regarding implant selection and positioning based on the enriched patient-specific kinematic data and information on the implant system;
performing a simulation to test the planning with regard to mechanical limits of the implant system, taking into account the patient-specific kinematic data and the patient data; and
one of:
approving the planning when the mechanical limits of the implant system have not been exceeded, or
suggesting a plan modification to comply with the mechanical limits of the implant system”.
The limitations of “enriching the patient-specific kinematic data with comparative data to generate enriched patient-specific kinematic data, the comparative data comprising historical data similar to the patient-specific kinematic data based on older or earlier insertions of the implant system;
determining a phenotype of the patient based on the patient-specific kinematic data; performing planning regarding implant selection and positioning based on the enriched patient-specific kinematic data and information on the implant system; performing a simulation to test the planning with regard to mechanical limits of the implant system, taking into account the patient-specific kinematic data and the patient data; and one of: approving the planning when the mechanical limits of the implant system have not been exceeded, or suggesting a plan modification to comply with the mechanical limits of the implant system” correspond to certain methods of organizing human activity. This is a method of managing interactions between people, such as user following rules and instructions. The mere nominal recitation of a generic processor and generic network devices does not take the claim out of the methods of organizing human interactions grouping. Thus, the claims recite an abstract idea.
The limitation of “detecting patient-specific kinematic data and patient data” corresponds to mere data gathering, since the current specification recites “…the preoperative, intraoperative and
postoperative detection of patient-specific kinematics using suitable methods known from the
state of the art.” in [0012].
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Claims 14-23 are ultimately dependent from claim 13 and include all the limitations of claim 13. Therefore, claims 14-23 recite the same abstract idea. Claims 14-23 describe a further limitation regarding the basis for planning and determining implant selection and positioning for a patient. These are all just further describing the abstract idea recited in claim 13, without adding significantly more.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claim recite the additional elements of “a first data device”, “a second data device”, “a third data device”, “a control unit for controlling the first data device, second data device and third data device…”, “performing a simulation to test the planning with regard to mechanical limits of the implant system, taking into account the patient-specific kinematic data and patient data”, which are hardware and software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)).
Claims also recite other additional limitations beyond abstract idea, including functions such as detecting (gathering)/storing data from/to a database, displaying/sending data are insignificant extra-solution activities (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using data devices and control unit to perform both the planning and determining steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claims are not patent eligible.
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 13-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miles et al. (hereinafter Miles) (US 8,983,813 B2).
Newly added claim 13 recites a system of an integrated therapy chain for planning and carrying out insertion of an implant system, which is a specific or selectable implant system, the integrated therapy chain having a preoperative therapy step, an intraoperative therapy step and a postoperative therapy step, the system comprising:
a first data device for detecting, processing and providing patient-specific kinematic data (Miller discloses “…receive, via the data interface, patient specific data for deriving patient data, the patient specific information being indicative of one or more dynamic characteristics;…” in col. 23, lines 30-33, “…the one or more dynamic characteristics comprises a virtual prediction based on one or more of joint kinematics data; joint loading data;…” in col. 23, lines 60-62);
a second data device for detecting, processing and providing patient data (Miller discloses “…a processor for processing digital data…” in col. 23, line 22);
a third data device for storing and providing data of the implant system (Miller discloses “…a memory device for storing digital data including computer program code and being coupled to the processor via a bus;…” in col. 23, lines 23-25); and
a control unit for controlling the first data device, the second data device and the third data device, and for performing the preoperative therapy step, the intraoperative therapy step and the postoperative therapy step based on the patient-specific kinematic data, the patient data, and the data of the implant system (Miller discloses “the alignment configuration of the orthopaedic implant can be accurately modeled for fitting the orthopaedic implant to the patient’s joint by virtue of the virtual prediction based on the joint kinematics data, joint loading data, and joint articulation behaviour data.” in col. 11, lines 63-67),
the first data device being configured to provide at least a first data set and a second data set (Miller; col. 23, lines 17-67),
the first data set comprising the patient-specific kinematic data (Miller; col. 23, lines 17-67),
the second data set comprising historical data similar to the patient-specific kinematic data based on older or earlier insertions of the implant system (Miller; col. 23, lines 17-67 and col. 30, lines 31-47),
the second data set configured to enrich the first data set with empirical values from the historical data (Miller; col. 23, lines 17-67),
the preoperative therapy step comprising a detection of the patient-specific kinematic data, a planning of an insertion of the implant system, and a simulation of the insertion of the implant system (Miller; col. 23, lines 17-67, col. 38, lines 31-47),
the intraoperative therapy step comprising inserting the implant system (Miller; col. 54, lines 15-20), and
the postoperative therapy step comprising a rehabilitation (Miller; col. 53, lines 8-21),
the planning of the insertion of the implant system configured to determine implant selection and positioning based on an enriched patient-specific kinematic data and information on the implant system (Miller; col. 54, lines 15-20), and
the simulation of the insertion of the implant system configured to test mechanical limits of the implant system, taking into account the patient-specific kinematic data and the patient data (Miller; col. 46, line 57 to col. 47, line 4).
Newly added claim 14 recites the system according to claim 13, wherein the preoperative therapy step further comprises choosing an optimal time for surgery (Miller; col. 58, lines 1-8).
Newly added claim 15 recites the system according to claim 13, wherein the preoperative therapy step is configured to detect and process the patient-specific kinematic data in the first data device, and detect and process the patient data in the second data device (Miller; col. 58, lines 1-8).
Newly added claim 16 recites the system according to claim 15, wherein the first data device is configured to determine kinematics and a phenotype from the patient-specific kinematic data (Miller; col. 23, lines 17-67).
Newly added claim 17 recites the system according to claim 13, wherein the system comprises a fourth data device for storing, processing, and providing image material (Miller; col. 23, lines 17-67).
Newly added claim 18 recites the system according to claim 17, wherein the preoperative therapy step is further configured to detect the image material and process the image material in the fourth data device (Miller; col. 23, lines 17-67).
Newly added claim 19 recites the system according to claim 18, wherein the preoperative therapy step is configured to determine at least an implant type and an implant size based on processed data of the data devices and the data of the third data device (Miller; col. 23, lines 17-67).
Newly added claim 20 recites the system according to claim 19, wherein the fourth data device is configured to determine a bone morphology based on the image material (Miller; col. 39, lines 38-50, col. 57, lines 22-25).
Newly added claim 21 recites the system according to claim 20, wherein the preoperative therapy step is configured to test mechanical limits of the implant system based on the planning of the insertion of the implant system, the bone morphology, and an implant orientation (Miller; col. 39, lines 38-50, col. 57, lines 22-25).
Newly added claim 22 recites the system according to claim 21, wherein the intraoperative therapy step is configured to implement the planning of the insertion of the implant system, based on the simulation of the insertion of the implant system, using a navigation or robotic system (Miller; col. 44, lines 45-65).
Newly added claim 23 recites the system according to claim 22, wherein the rehabilitation is adaptable based on the patient-specific kinematic data and a preoperative requirement profile (Miller; col. 42, line 55 to col. 43, line 4).
Newly added claim 24 recites a method for preoperative preparation of a surgery for insertion of an implant system into a patient, the method comprising the following steps:
detecting patient-specific kinematic data and patient data (Miller discloses “…receive, via the data interface, patient specific data for deriving patient data, the patient specific information being indicative of one or more dynamic characteristics;…” in col. 23, lines 30-33, “…the one or more dynamic characteristics comprises a virtual prediction based on one or more of joint kinematics data; joint loading data;…” in col. 23, lines 60-62);
enriching the patient-specific kinematic data with comparative data to generate enriched patient-specific kinematic data, the comparative data comprising historical data similar to the patient-specific kinematic data based on older or earlier insertions of the implant system (Miller discloses “…a processor for processing digital data…” in col. 23, line 22);
determining a phenotype of the patient based on the patient-specific kinematic data (Miller; col. 38, lines 31-47);
performing planning regarding implant selection and positioning based on the enriched patient-specific kinematic data and information on the implant system (Miller; col. 54, lines 15-20);
performing a simulation to test the planning with regard to mechanical limits of the implant system, taking into account the patient-specific kinematic data and the patient data (Miller; col. 46, line 57 to col. 47, line 4); and
one of: approving the planning when the mechanical limits of the implant system have not been exceeded, or suggesting a plan modification to comply with the mechanical limits of the implant system (Miller; col. 55, lines 4-13).
Conclusion
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/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687