DETAILED ACTION
Status of Claims
This is a non-final office action on the merits in response to the arguments and/or amendments filed on 22 September 2025 and the request for continued examination filed on 22 September 2025.
Claim(s) 1, 10, and 17 is/are amended.
Claim(s) 1, 3-7, 9, 10, and 12-19 is/are currently pending and have been examined.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22 September 2025 has been entered.
Information Disclosure Statement
The information disclosure statement(s) (IDS(s)) submitted on 22 September 2025 are partially in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner as marked.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-7, 9, 10, and 12-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims not listed below are rejected for dependency.
Amended claim 1 recites the non-original limitation output a notification to a surgeon associated with the surgical device, wherein the notification comprises an indication that the surgical device has been reconfigured and the degree-of-confidence level. What appear to be the most relevant portions of the originally filed disclosure state:
[0362] The system 23000 may make this notification and/or configuration-change recommendation based on data from a single source or based on data from multiple sources. When data is considered from multiple sources, the recommendation may be able to be made with a higher confidence than when a single source is considered. A healthcare professional may be more likely to consider and adopt the notification and/or the configuration change knowing that various sensor inputs have contributed to it.
[0393] The degree-of-confidence 23068 may include any information indicative of the strength of the decision making associated with the settings recommendation engine 23024 and the scoring rubric 23030. For example, as shown in FIG. 14A, the degree-of-confidence 23068 may be associated with the extent to which the resultant score 23045 exceeds the threshold 23047. For example, as shown in FIG. 14B, the degree-of-confidence 23068 may be associated with the extent to which the vector 23049 is distant from a centroid of a respective evaluation zone 23054. 23056, 23058. The degree-of-confidence 23068 may be influenced by the specific settings recommendation engine 23024 itself. For example, settings recommendation engines 23024 may include a factor to normalize the degree-of-confidence 23068 across the active and/or all-available settings recommendation engines 23024. For example, a settings recommendation engine 23024 being serviced by many different sensor values (and corresponding factors) may amplify the degree-of-confidence 23024 otherwise generated by its scoring rubric 23030. For example, a settings recommendation engine 23024 being serviced by few different sensor values (and few corresponding factors) may amplify the degree-of-confidence 23024 otherwise generated by its scoring rubric 23030. The degree-of-confidence 23068 may include data intended for output to a human interface device, structure data (for output and for logging for example), and the like. The degree-of-confidence 23068 may include information that surgeon and/or other health care professional may find relevant when evaluating the recommended surgical device setting 23066.
The above disclosures contemplate a notification which includes a recommendation to change a surgical device setting and an associated degree of confidence. However, these disclosures do not contemplate providing a degree of confidence in conjunction with an indication that the device has already been reconfigured. One of ordinary skill in the art would not consider such a notification supported by these disclosures, as they specifically contemplate providing confidence metrics in advance of the adaptation of a device configuration. The remainder of the disclosure similarly does not support the identified limitation. Thus limitation is not supported by the originally filed disclosure.
Because the claims include a non-original limitation which is not supported by the originally filed disclosure, one of ordinary skill in the art would not recognize applicant as possessing the claimed invention at the time of filing. Therefore the claim is rejected based on the written description requirement. Claims 10 and 17 are similarly rejected.
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, 3-7, 9, 10, and 12-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 10, which is representative of claim 1 and 17, recites: a
receiving first pre-operative sensor data
receiving second pre-operative sensor data
select a settings recommendation engine, from a plurality of setting recommendation engines, based on a surgical procedure type in which a surgical device is to be used, wherein the setting recommendation engine comprises a first weighted factor and a second weighted factor;
determining a first weighted value of the first pre-operative sensor data based on the first weighted factor;
determining a second weighted value of the second pre-operative sensor data based on the second weighted factor;
determining a score associated with a combination of the first weighted value and the second weighted value;
selecting a setting configuration package based on the score satisfying a threshold associated with the setting configuration package;
determining a degree-of-confidence level based on the score;
sending at least one output
output a notification to a surgeon associated with the surgical device, wherein the notification comprises an indication that the surgical device has been reconfigured and the degree-of-confidence level.
The preceding recitation of the claim has had strikethroughs applied to the additional elements beyond the abstract idea to more clearly demonstrate the limitations setting forth the abstract idea. The remaining limitations describe a concept of making observations, determining a configuration of a surgical device based on the observations, and communicating the determined configuration. This concept describes a mental process that surgical technician should follow to determine and communicate device configurations similar to the “mental process that a neurologist should follow when testing a patient for nervous system malfunctions” given in MPEP 2106.04(a)(2)(II)(C) as an example of managing personal behavior in the methods of organizing human activity sub-grouping. As such, these limitation set forth a method of organizing human activity. Alternative, the described concept analogous to the examples of “observation”, “evaluation”, “judgement”, and “opinion” given in MPEP 2106.04(a)(2)(III). Further, this concept as claimed does not require a scale of data beyond the mental faculties of a human being and the operations and can be performed in the human mind or with pen and paper. As such, these limitation set forth a mental process. Therefore, in either case, the claims are determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
Claims 1 and 17 recite the additional element of a processor, while claim 10 describes the method as computer-implemented. These additional elements are recited at an extremely high level of generality and are interpreted as generic computing devices used to implement the abstract idea. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not integrate the abstract idea into a practical application.
The claims further recite the additional element of sending an output to the surgical device. The claim provides no meaningful limitations on how this sending is achieved. For an abstract idea including determining a configuration of a surgical device, the output or application of a determined configuration does not impose a meaningful limitation on the abstract idea. Further, this additional element amounts to necessary data outputting. Therefore this limitation is considered insignificant extra-solution activity. As such, this additional element does not integrate the abstract idea into a practical application.
The claims further recite the additional elements of receiving data from a first sensor system and a second sensor system, wherein the second sensor system is different than the first sensor system, wherein the first sensor system is any of a first patient sensor system or a first environment sensor system, and wherein the second sensor system is any of a second patient sensor system or a second environmental sensor system. These sensor systems are recited with almost complete generality, only necessarily being two device that sense. Note the extreme breadth of “patient sensor system” and “environment sensor system”. These limitations do not refer to any particular sensor, and between the targets of “patient” and “environment” these sensor systems collectively encompass any type of sensor. For an abstract idea including the use of observation data, receiving data from generic sensors does not impose a meaningful limitation on the abstract idea. Further, this additional element amounts to necessary data gathering. Therefore this limitation is considered insignificant extra-solution activity. As such, this additional element does not integrate the abstract idea into a practical application.
Claim 17 further recites the additional element of a driver. This element is recited with almost complete generality, only necessarily being something which drives in association with a surgical action. The incorporation of this elements into the claims amounts to reciting “apply it” with the abstract idea. As such, this additional element does not integrate the abstract idea into a practical application.
There are no further additional elements. When considered as a combination, the additional elements do not meaningfully limit the implementation of the abstract idea. Instead, the additional elements only generally link the abstract idea and insignificant extra-solution activity to a technological environment of computing devices and surgical devices. As such, the combination of additional elements does not integrate the abstract idea into a practical application. Therefore the claims are determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, the additional elements are considered for whether they integrate the abstract idea into a practical application.
As previously noted, the claims recite additional elements which may be interpreted as generic computing devices used to implement the abstract idea. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing does not add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, this additional element does not amount to significantly more.
As previously noted, the claims recite the additional element of sending an output to a surgical device. Per MPEP 2106.05(d)(II), transmitting data is a well-understood, routine, and conventional computer function. The conventionality of this additional element supports the prior determination that this additional element amounts to insignificant extra-solution activity. As such, this additional element does not amount to significantly more.
As previously noted, the claims recite the additional element of receiving data from two sensor systems. Per MPEP 2106.05(d)(II), receiving data is a well-understood, routine, and conventional computer function. The conventionality of this additional element supports the prior determination that this additional element amounts to insignificant extra-solution activity. As such, this additional element does not amount to significantly more.
As previously noted, the claims recite a driver. However, Shields et al. (US 2014/0276978 A1) demonstrates ([0004]) that surgical devices containing drivers were conventional long before the priority date of the claimed invention. As such, this additional element does not amount to significantly more.
There are no further additional elements. When considered as a combination, the additional elements do not meaningfully limit the implementation of the abstract idea. Instead, the additional elements only generally link the abstract idea and insignificant extra-solution activity to a technological environment of computing devices and generic surgical devices. As such, the combination of additional elements does not amount to significantly more. Therefore, when considered individually and as an ordered combination, the additional elements of the independent claims do not amount to significantly more than the judicial exception. Thus the independent claims are not patent eligible.
Dependent claims 3, 4, 9, 12, 13, 18, and 19 only further narrow the abstract idea. The previously identified additional elements, individually and as a combination do not integrate the narrowed abstract idea into a practical application for reasons equivalent to those provided above. The previously identified additional elements, individually and as a combination do not amount to significantly more than the narrowed abstract idea for reasons equivalent to those provided above. Dependent claims 5-7 and 14-16 further specify the combination of the sensing systems, but the sensor systems continue to be generic sensors which do not either integrate the abstract idea or amount to significantly more than the abstract idea. Thus as the dependent claims remain directed to a judicial exception, and as the additional elements of the claims do not amount to significantly more, the dependent claims are not patent eligible.
Response to Arguments
Applicant’s Argument Regarding 101 Rejections of claims 1, 3-7, 9, 10, and 12-19:
As described in the specification, the output may be sent to configurable surgical equipment. Such output could be used to reconfigure the surgical equipment for the surgical procedure. As the output(s) are generated, the configurable surgical equipment could be configured to operate consistently with the output(s). Such configuration of surgical equipment is an improvement to a tangible technology, and such configuration promote a technological improvement to surgical equipment.
The ability to determine specific reconfigurations for surgical devices can result in an improvement to patient outcome success during surgical procedures.
As a surgical procedure considers an insurmountable amount of data during surgical procedure planning and even on-going surgical procedures with on-the-fly surgical device adjustments, the ability to process sensor data to determine a score based on weighted values associated with the massive amounts of sensor data could drastically improve surgical device performance.
The determination of a degree-of-confidence level for a recommendation improves a health care professional’s decision making as providing relevant information to be considered by the health care professional when evaluating the recommended surgical device setting. For example, a health care professional would be more likely to consider a configuration recommendation with the knowledge that a high degree-of-confidence is associated with the recommendation.
Examiner’s Response: Applicant's arguments filed 22 September 2025 have been fully considered but they are not persuasive.
Per MPEP 2106.05(a), “If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification.” Here, the specification does not appear to provide a technical explanation of how to implement an output that reconfigured surgical equipment. As such, the asserted improvement does not constitute a technical improvement for the purposes of subject matter eligibility.
Per MPEP 2106.05(a), “It is important to note, the judicial exception alone cannot provide the improvement.” The asserted improvement of this argument is part of the abstract idea.
The claims do not require the processing of “an insurmountable amount of data.” As the claim encompasses processing both large and small sets of data, they do not reflect an improvement in processing large data sets.
Examiner notes that the referenced features do not correspond to the actual language of the claims. Note the claim language “wherein the notification comprises an indication that the surgical device has been reconfigured.” The claims do not provide a recommendation and confidence value for a doctor to consider for whether to accept, but rather implement a configuration and then inform the doctor of the configuration and confidence after the fact. However, in the interest of prosecution, examiner notes that recommendation prior to implementation of configuration parameters does not immediately appear eligible. Examiner notes Recentive Analytics, Inc, where the generation of an optimized set of parameters to be implemented did not render the claims eligible.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found in the PTO-892 of the prior office action dated 26 February 2024.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
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/Bion A Shelden/Primary Examiner, Art Unit 3685 2025-01-05