DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This Final Office Action is in response to the RCE filed 04/29/2026. Claims 1, 10 and 17 are amended. Claim 3 is cancelled. Claims 21-26 are new. Claims 1-2, 4, 6-14, 16-18 and 20-26 are currently pending and considered herein.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/29/2026 has been entered.
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 1-2, 4, 6-14, 16-18 and 20-26 are rejected under 35 U.S.C. §101 because they recite an abstract idea without significantly more.
Claim 1 recites:
A method of planning a hip arthroplasty for a subject, comprising: receiving at least one image of the subject, wherein the at one least image is substantially acquired from a sagittal plane when the subject is standing; calculating at least one spinopelvic metric from the at least one image; and calculating a hip arthroplasty risk characteristic of the subject based on the calculated at least one spinopelvic metric, calculating post-surgical standing combined sagittal index; and indicating one or more proposed orientations for an acetabular cup implant for the subject based on the calculated at least one spinopelvic metric, wherein calculating a hip arthroplasty risk characteristic of the subject is further based on the one or more proposed orientations for an acetabular cup implant, wherein the hip arthroplasty risk characteristic of the subject indicates an increased likelihood of negative outcomes if the calculated post-surgical standing combined sagittal index is below 200 +/- 10 or the standing combined sagittal index is above 250 +/- 10.
Claim 10 recites:
A method of determining a range of acetabular cup orientation angles for an acetabular cup implant for a subject, comprising: receiving at least one image of the subject, wherein the at least one image is substantially acquired from a sagittal plane when the subject is standing; calculating at least one spinopelvic metric from the at least one image; receiving a range of anteversion angles; receiving a range of inclination angles; and determining a range of acetabular cup orientation angles for an acetabular cup implant for the subject based on the calculated at least one spinopelvic metric, the received range of anteversion angles, and the received range of inclination angles, wherein the range is determined such that a calculated post-surgical standing combined sagittal index is above 200 +/- 10 and below 250 +/- 10.
Claim 17 recites, wherein the abstract elements are not emboldened:
A computer-implemented method of determining a range of orientation angles for an acetabular cup implant for a subject, comprising: receiving a range of anteversion angles; receiving a range of inclination angles; receiving at least one spinopelvic metric of the subject; and determining a range of acetabular cup orientation angles for an acetabular cup implant for the subject based on the at least one spinopelvic metric, the received range of anteversion angles, and the received range of inclination angles, wherein the range is determined such that a calculated post-surgical standing combined sagittal index is above 200 +/- 10 and below 250 +/- 10.
The claimed invention is broadly directed to the abstract idea of collecting patient information, analyzing the information, and calculating a range of results related to the patient information and proposed orientations based on the analyses.
The limitations of “receiving at least one image of the subject, wherein the at one least image is substantially acquired from a sagittal plane when the subject is standing; calculating at least one spinopelvic metric from the at least one image; and calculating a hip arthroplasty risk characteristic of the subject based on the calculated at least one spinopelvic metric, calculating post-surgical standing combined sagittal index; and indicating one or more proposed orientations for an acetabular cup implant for the subject based on the calculated at least one spinopelvic metric, wherein calculating a hip arthroplasty risk characteristic of the subject is further based on the one or more proposed orientations for an acetabular cup implant, wherein the hip arthroplasty risk characteristic of the subject indicates an increased likelihood of negative outcomes if the calculated post-surgical standing combined sagittal index is below 200 +/- 10 or the standing combined sagittal index is above 250 +/- 10,” of claim 1, “receiving at least one image of the subject, wherein the at least one image is substantially acquired from a sagittal plane when the subject is standing; calculating at least one spinopelvic metric from the at least one image; receiving a range of anteversion angles; receiving a range of inclination angles; and determining a range of acetabular cup orientation angles for an acetabular cup implant for a subject based on the calculated at least one spinopelvic metric, the received range of anteversion angles, and the received range of inclination angles, wherein the range is determined such that a calculated post-surgical standing combined sagittal index is above 200 +/- 10 and below 250 +/- 10” of claim 10, and “receiving a range of anteversion angles; receiving a range of inclination angles; receiving at least one spinopelvic metric of the subject; and determining a range of acetabular cup orientation angles for an acetabular cup implant for a subject based on the at least one spinopelvic metric, the received range of anteversion angles, and the received range of inclination angles, wherein the range is determined such that a calculated post-surgical standing combined sagittal index is above 200 +/- 10 and below 250 +/- 10” of claim 17, as drafted, are processes that, under the broadest reasonable interpretation, are an abstract idea that covers performance of the limitation as certain methods of organizing human activity. For example, but for the generic recitation of a computer-implemented method and images, analyzing patient data and determining relevant assessments and orientation angles based on the analyses, in the context of this claim, is an abstract idea that covers performance of the limitation as organizing human activity including following rules or instructions. These recited limitations fall within certain methods of organizing human activity grouping of abstract ideas because the limitations allowing access to patient data that is analyzed and an assessment result is generated based on the analyses related to hip arthroplasty and/or acetabular cup orientation and the patient’s condition. This is a method of managing interactions between people. Under its broadest reasonable interpretation, the limitations are categorized as methods of organizing human activity, specifically associated with managing personal behavior or relationships or interactions between people including a physician and her patient. Therefore, the limitation falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a). The mere nominal recitation of a generic computer and image does not remove the claims from the method of organizing human interactions grouping. Thus, the claims recite an abstract idea.
In addition, the claims recite under its broadest reasonable interpretation, an abstract idea that covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting a computer implemented method and image nothing in the claim element precludes the step from being performed in the mind. For example, but for the generic computing device language, a system for determining a patient’s condition and needs in the context of this claim encompasses one skilled in the pertinent art to manually determine using images the details of a patient’s situation and relevant orientations for a hip implant. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of being implemented by a generic computer and using images for the sending and receiving and calculation of information related to assessment of a patient. The devices in these steps are recited at a high-level of generality (i.e., as a generic processor/server/storage/display performing a generic computer function of receiving inputs, analyzing the inputs, and displaying or sending selected information) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements, alone or in combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The limitations appear to monopolize the abstract idea of patient analysis and general diagnostic techniques between a physician and her patient. Furthermore, there is no clear improvement to the underlying computer technology in the claim. And there is no actual manufacture of any implant found in the claim limitations, as urged previously by the Examiner. The claim is thus directed to an abstract idea.
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 elements of being implemented by a generic computer and using images amounts to no more than mere instructions to apply the exception using a computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Therefore, when considering the additional elements alone, and in combination, there is no inventive concept in the claim, and thus the claim is not patent eligible.
The dependent claims do not remedy the deficiencies of the independent claims with respect to patent eligible subject matter. The dependent claims further limit the abstract idea and do not overcome the rejection under 35 U.S.C. §101. Claims 2-4, 6-9, 11-14, 16, 18 and 20 further define calculating spinopelvic metrics, hip arthroplasty risk characteristics and proposed orientations of an acetabular cup implant which is recited at a high level of generality such that it amounts no more than mere instructions to apply the judicial exception using a generic computer component and cannot provide an inventive concept. Even in combination, the spinopelvic metrics, acetabular cup implant proposed orientation and potential risks do not integrate the abstract idea into a practical application and does not amount to significantly more than the abstract idea itself. Claims 21, 23 and 25 describe an artificial intelligence system for calculating metrics, which is recited at a high level of generality such that it amounts no more than mere instructions to apply the judicial exception using a generic computer component and cannot provide an inventive concept. Even in combination, the artificial intelligence system does not integrate the abstract idea into a practical application and does not amount to significantly more than the abstract idea itself. Claims 22, 24 and 26 further describe the artificial intelligence system as based on a machine learning model trained on a dataset related to a surgeon, which is recited at a high level of generality such that it amounts no more than mere instructions to apply the judicial exception using a generic computer component and cannot provide an inventive concept. Even in combination, the machine learning and training a model based on data related to a surgeon does not integrate the abstract idea into a practical application and does not amount to significantly more than the abstract idea itself.
Therefore, the claims are not patent eligible.
Response to Arguments
Applicant’s amendments and remarks filed April 29, 2026 have been fully considered, but they are not persuasive. The following explains why:
Applicant’s arguments pertaining to subject matter eligibility are not persuasive. The basis for the previous rejection under 35 U.S.C. §101 is still operative and the claims have been addressed with regard to the updated 35 U.S.C. §101 rejection discussed above, and considered under relevant sections of the MPEP. The arguments at pages 9-11 of Applicant’s Response are not persuasive. The Examiner disagrees there is not an abstract idea. The Examiner disagrees that there is a technological improvement presented in the claims. The examiner disagrees there is a practical application that is integrated in the claims. At Page 9, the Examiner disagrees that there is not an abstract idea of organizing human activity including following rules or instruction, because the claims are “patient specific.” A physician performing the abstract idea would perform the claimed limitations for each patient and for that particular patient as a matter of course, and a physician would use the claimed additional elements as insignificant extra-solution activity to perform the abstract idea of organizing human activity including following rules or instructions, as discussed. Further, the calculations and metrics could be performed by a human mind and encompass the abstract idea of mental processes. That it may be tedious or laborious to perform analyses in the mind or manually is not of consequence in the eligibility analysis. The Examiner disagrees at Page 9 that there is a technological improvement to surgical outcomes, however this is not claimed and this is not a technological improvement to the underlying technology of calculating metrics for an implant and computer devices for doing so.
In addition, the Examiner disagrees at Pages 10-11 that the claims are integrated into to a practical application. The Examiner does not allege that anything is well-understood, routine or conventional in the claims, but that generic computer technology is being leveraged as a tool to perform the abstract idea (judicial exception). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The “additional element” argued at Pages 10-11 is actually cited as part of the abstract idea and is not an additional element. Further, if the claims were directed to actually manufacturing an implant, then there would be at least a practical application if not no abstract idea present.
The Examiner disagrees with the arguments at Pages 11-12 that there is “significantly more” than the abstract idea. Here even the trained machine learning model using surgeon data and AI system of the dependent claims act as a computer tool used to employ the judicial exception and without significantly more. The generic “computer-implemented method” and “artificial intelligence system” in the claims are recited at a high level, and amount to applying the exception using a generic computer (See e.g. Updated PEG Example 47, claim 2, where the “detecting” and “analyzing” were mental processes, and “using the trained ANN” amounted to generic computer implementation). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. For at least these reasons and those stated above, the amended claims are not patent eligible.
The Examiner again notes, if there is an actual manufacturing of an acetabular cup implant that is recited in the claims, supported by the specification and based on the calculations/conditions in the limitations, then there would be evidence for not having an abstract idea, or that there is a practical application thereof.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM T. MONTICELLO whose telephone number is (313) 446-4871. The examiner can normally be reached M-Th; 08:30-18:30 EST.
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/WILLIAM T. MONTICELLO/Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682
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