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 Amendment and Remarks filed 8/18/2025. Claims 1, 4, 10, 13, 16-18 and 20 are amended. Claims 5, 15 and 19 are cancelled. Claims 1-4, 6-14, 16-18 and 20 are pending and considered herein.
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 1-4, 6-14, 16-18 and 20 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, and calculating post-surgical standing combined sagittal index, 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 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; 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.
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 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.
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, 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 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; 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 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, or as mathematical concepts) 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. 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 detail 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. Therefore, the claims are not patent eligible.
Allowable Claims (Over Prior Art)
Claims 1-4, 6-14, 16-18 and 20 are allowable over the prior art. The references fail to specifically disclose alone or in combination “calculating post-surgical standing combined sagittal index, 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.” U.S. 2015/0142372 A1 to Singh and U.S. 2021/0059838 A1 to Bodner teaches similar angles and indices but not these exact configurations as claimed. Thus, the claims are allowable over the prior art.
Response to Arguments
Applicant’s amendments and remarks filed August 18, 2025 have been fully considered, but they are not entirely persuasive. The following explains why:
Applicant’s arguments pertaining to prior art rejections are persuasive. As such, the rejection under 35 U.S.C. §103 has been withdrawn. The Examiner agrees with the arguments pertaining to prior art references at pages 11-12 of the Applicant’s Remarks and in view of the new claims presented.
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 the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG). The arguments at pages 7-10 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. It appears the computer technology is leveraged as mere instructions to apply the judicial exception abstract idea. 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 claims are not patent eligible.
If there is an actual manufacturing of an acetabular cup implant that is recited in the claims and based on the calculations/conditions in the limitations, then there would be a stronger argument there is not an abstract idea, or there is a practical application thereof.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 3681
/MARC Q JIMENEZ/Supervisory Patent Examiner, Art Unit 3681