DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/18/2026 has been entered.
Acknowledgments
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-6 are pending.
This action is Non-Final.
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 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 1
2) performing posture analysis on the evaluation imaging data of full body sagittal posture under different body postures obtained to obtain analysis results of degree of sagittal imbalance and severity of hip abduction deformity of the patient before surgery (mathematical concepts, mental processes)
3) predicting pelvic posture rebalance state in a sagittal plane of the patient after hip replacement surgery according to the analysis results of the degree of sagittal imbalance and the severity of hip abduction deformity as well as the evaluation result of functionality of hip extension muscle clusters of the patient before surgery (mathematical concepts, mental processes)
based on the pelvic posture rebalance state which is predicted, determining a target implantation angle of a cup prothesis in the hip replacement surgery (mental process)
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
1) obtaining evaluation imaging data of full body sagittal posture of a patient before surgery under different body postures by a medical imaging equipment, performing physical examination on the patient to obtain fixed flexion deformity information of bilateral hip joints and an evaluation result of functionality of hip extension muscle clusters (steps related to data gathering; insignificant pre-solution activities)
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. 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 to the exception. Analyzing the additional claim limitations individually, the additional limitation that is not directed to the abstract idea are the same as those identified above in relation to step 2A. Such limitations related to the obtained evaluation imaging data of full body sagittal posture of a patient before surgery under different body postures, and obtained fixed flexion deformity information of bilateral hip joints and an evaluation result of functionality of hip extension muscle clusters through physical examination are recognized by the courts as routine data gathering in order to input data to the mathematical algorithm/mental processes, and thus, do not add a meaningful limitation to the method as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm/mental process, as argued and evidence presented in the affidavit filed 1/5/2026 that such steps are well-known, routine, and conventional. The method does not contain any computing structure, such that the steps can all be analog/mental processing of the information from the data gathered which further supports that the claims are directed to a judicial exception without significantly more. The additional limitations recited in the dependent claims are merely directed to further details of the data gathered, intended results, or to further to further details of the mathematical concepts/mental processes (A more specific abstraction is still an abstraction). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims and affidavit filed 5/18/2026.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112 have been fully considered and are persuasive due to the amendment to the claims; the rejections have been withdrawn.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered but are not persuasive. Specific sections are directly addressed as follows, but in general the claims recite judicial exceptions without significantly more or a practical application of the claimed exception.
“Applicant contends that the specified data, as opposed to generic data collection, differs from conventional hip-joint imaging acquisition which typically includes only the AP and frog-leg lateral views of the hip rather than a lateral of the spine-pelvic). Applicant contends that this enhanced data collection, coupled with specific technical processing of the acquired data, e.g., the classification and prediction steps in claim 6 are based on biomechanical principles of spinopelvic balance (such as PI-LL difference, SVA, and other parameters) defines a method that better simulates the complex biomechanical compensation mechanism (e.g., Spinopelvic Compensation) between the human spine and pelvis. Applicant maintains that this Spinopelvic Compensation, is not a man-made mathematical rule, but is the result of computations based on a unique set of specific physical phenomenon, specifically the state parameters (pelvis angles) of a physical entity (patient).”
The examiner respectfully disagrees. Whether gathering generic data or gathering specific data the limitation is still collecting or gathering data so that the abstract ideas can happen. The data is not disclosed as being collected in a special way, or with a special machine. Additionally, the position from prior filed affidavit was that the data gathering are well-known, routine, conventional in the art, and as such, these steps are to insignificant pre-solution activities related to data gathering for the claimed algorithm which recites the judicial exception. The claims and the application make a determination in planning, but do not have any post solution activities being performed in response to the exception steps as the claims stop at planning by predicting post-surgery features determined before any surgery. For example, performing total hip replacement surgery based on the posture rebalance prediction is not a step claimed and does not appear to be within the bounds of the disclosure as filed. However, the claims, and application as-filed, stop at the prediction.
Applicant argues the claims are not directed to an abstract idea because the claims are to medical technology applications.
The examiner respectfully disagrees. To date, no brightline test has been put in place or decided by the courts that medical technology is automatically patent eligible or receives automatic streamline determinations to be patent eligible material. The claims must use the Mayo/Alice analysis as was set forth in this action.
“Applicant submits that the amended claim 1 transforms the predicted state into an operational guide for physical surgical instruments or physical parameters for prosthesis implantation of the functional cup angle surgery. This constitutes a "practical application" of the abstract concept, as it guides a surgeon or surgical robot on how to position the prosthesis in physical space for a particular subject.
Applicant contends, therefore, that the present application has integrated the features of the claims into a specific application process, thereby achieving a technical improvement and a practical application. Regarding the "Inventive Concept," Applicant contends that one of ordinary skill in the art understands that the traditional methods have one or more of the following technical problems: "When a traditional method is used to evaluate the sagittal posture of a patient before surgery, it is easy to cause problems that: 1) concerning a patient suffering from sagittal imbalance, it is impossible to quantitatively predict the postoperative sagittal balance state of full body and postoperative pelvic posture; 2) it is impossible to quantitatively predict a postoperative spatial position of the cup; 3) it is difficult to locate, according to a functional angle, the orientation of the cup in total hip replacement surgery ; 4) it is prone to complications after the rebalance, such as hip joint stress concentration, impact, dislocation, and prosthesis loosening." See, Specification, page 1.Applicant submits that the method defined by the pending claims solves these technical problems and achieves the following effects: The objectives of ... which can accurately predict the sagittal balance state of the pelvis after hip replacement surgery, and provide a reference basis for planning a target implantation angle of a cup prosthesis in total hip replacement surgery," (emphasis added) See, Specification, page 1, and By using the above technical solution, ..., and prediction for postoperative pelvic sagittal posture can be implemented for different types of patients based on results of the analysis so that a prediction result for the patient can be more accurate. 2. Based on the evaluation imaging data of the patient, it can accurately determine the pelvic posture after total hip replacement surgery, and provide the total hip replacement with an accurate reference basis for planning the functional cup angle surgery, thereby optimizing the kinematics dynamics effect of hip replacement, avoiding dysfunction of the prosthesis position due to rebalancing of pelvic posture, and reducing the risk of complications such as impact, dislocation, wear, loosening, etc." (emphasis added) See, Specification, page 4.”
The examiner respectfully disagrees. Applicant is reminded that abstract ideas cannot provide a practical application or significantly more (e.g., an improvement). Both Step 2A Prong 2 and Step 2B require an additional element, not an abstract idea, to provide a practical application or significantly more (e.g., an improvement). See Genetic Technologies Limited v. Merial LLC (Fed Cir 2016). Here, the limitations “…..” are abstract ideas and not additional elements. The additional elements of claims ____ are merely generically recited computer elements used as tools for executing the abstract ideas or insignificant extra-solution activity. See MPEP 2106.05(a), wherein “[i]t is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.” In this case, the improvement is within the exception itself, and as addressed prior, the additional elements are directed to data gathering. Novelty of a judicial exception does not equate to patentable subject matter. Such exception must be claimed in a form that is significantly more than or a practical application of the recited judicial exception. In this case, considering the limitations as a whole, the claims are directed to the judicial exception as such is recited without significantly more than or a practical application of such.
The rejections are respectfully maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2007/0083384, US 2015/0088145, US 2017/0128135, US 2020/0168318, US 2021/0369472, US 2021/0059838, US 2022/0249248, US 2023/0285082, US 2023/0368922, US teach related/relevant technology.
No prior art rejections have been applied, but the claims are not allowable due to the rejections under 101.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
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