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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12 August 2026 has been entered.
Status of Claims
In the reply filed to the application filed on 12 August 2026 the following changes have been made: amendments to claims 21-22, 24-29, 31-36, 38, and 42. Claims 23, 30, 37, and 39-41 have been canceled.
Claims 21-22, 24-29, 31-36, 38, and 42 are currently pending and have been examined.
Notice to Applicant
Applicant’s specification [0433] contains two recitations of mediums: computer-readable medium/media and non-transitory computer-readable medium. The specification does not clarify that a recitation of just a computer readable storage medium is not to be construed as being transitory signals per se. Thus, it is not clear from applicant’s claim 35 if transitory signals are excluded.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e)
or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has
not complied with one or more conditions for receiving the benefit of an earlier
filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/611,340; 62/611, 339; 62/611,341; 62/640,417; 62/640,415; 62/650,898; 62/650,882; 62/650,877; 62/650,887; 62/659,900; 62/692,768; 62/692,748; 62/692,747; and, 62/729,177 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For claims 21, 28, and 35 the prior-filed application does not provide support for “wherein the second operational threshold is indicated by a second contextual dataset that is relevant to adjusting the parameter”, “determine an adjustment value of the parameter based on a hierarchical resolution of the difference between the first operational threshold and the second operational threshold”, “generate, via the surgical hub, control instructions that cause the surgical instrument to alter an operation associated with the surgical procedure in accordance with the adjustment value of the parameter”, and “wherein the one or more processors are further configured to arrange the first and second contextual datasets in a hierarchy of priority, the hierarchy of priority comprises a primary tier, a secondary tier that is lower in priority than the primary tier, and a tertiary tier that is lower in priority than the secondary tier, such that the first contextual dataset possesses a higher priority than the second contextual dataset and is placed in a tier among the primary, secondary, and tertiary tiers that is a higher priority than where the second contextual dataset is placed.” Examiner cannot find disclosure of the second operational threshold indicated by a second contextual dataset that is relevant to adjusting the parameter, determining an adjustment value of the parameter based on a hierarchical resolution of the difference between the first operational threshold and the second operational threshold, and generating, via the surgical hub, control instructions that cause the surgical instrument to alter an operation associated with the surgical procedure in accordance with the adjustment value of the parameter. Examiner also cannot find disclosure of the one or more processors being further configured to arrange the first and second contextual datasets in a hierarchy of priority, the hierarchy of priority comprises a primary tier, a secondary tier that is lower in priority than the primary tier, and a tertiary tier that is lower in priority than the secondary tier, such that the first contextual dataset possesses a higher priority than the second contextual dataset and is placed in a tier among the primary, secondary, and tertiary tiers that is a higher priority than where the second contextual dataset is placed. For claims 22, 29, and 36 the prior-filed application does not provide support for “wherein the first contextual dataset comprises a first constraint, wherein the second contextual dataset comprises a second constraint, and wherein the one or more processors are further configured to generate a third constraint that satisfies the first constraint and the second constraint.” Examiner cannot find disclosure of the first contextual dataset comprising a first constraint, the second contextual dataset comprising a second constraint, and generating a third constraint that satisfies the first constraint and the second constraint. For claims 24, 31, and 38 the prior-filed application does not provide support for “wherein the hierarchical resolution of the difference between the first contextual dataset and the second contextual dataset comprises obtaining a third contextual dataset at the same or higher tier than the first contextual dataset, wherein the third contextual dataset comprises data to resolve the difference between the first operational threshold and the second operational threshold.” Examiner cannot find disclosure of the hierarchical resolution of the difference between the first contextual dataset and the second contextual dataset comprising obtaining a third contextual dataset at the same or higher tier than the first contextual dataset, wherein the third contextual dataset comprises data to resolve the difference between the first operational threshold and the second operational threshold. For claims 25 and 32 the prior-filed application does not provide support for “wherein the first contextual dataset comprises an exception to refer to a lower tiered contextual dataset under a specific circumstance, wherein the hierarchical resolution of the difference between the first contextual dataset and the second contextual dataset comprises determining that under the specific circumstance the first contextual dataset instructs to defer to the second contextual dataset for the adjustment value of the parameter.” Examiner cannot find disclosure of the first contextual dataset comprising an exception to refer to a lower tiered contextual dataset under a specific circumstance, wherein the hierarchical resolution of the difference between the first contextual dataset and the second contextual dataset comprises determining that under the specific circumstance the first contextual dataset instructs to defer to the second contextual dataset for the adjustment value of the parameter. For claims 26 & 33 the prior-filed application does not provide support for “wherein one or more processors are further configured to inform a user that the difference between the first operational threshold and the second operational threshold cannot be resolved by the surgical hub.” Examiner sees generic disclosure of informing optimization outcomes on pg. 78 of 62/611,340; generic disclosure of informing machine learning and decision-making process in pg. 310 of 62/611,339; generic disclosure of informing the user of the state of the ultrasonic device in pg. 43 of 62/640,415; generic disclosure of informing the processor regarding the various sensor data in pg. 32 of 62/650,877; generic disclosure of informing the surgeon as the surgeon approaches a nerve and/or a nerve bundle in pg. 25 of 62/650,887; and, generic disclosure of informing the clinicians' decisions during the surgical procedure in pg. 1542 of 62/659,900. However, examiner cannot find disclosure of one or more processors configured to inform a user that the difference between the first operational threshold and the second operational threshold cannot be resolved by the surgical hub. For claims 27 and 34 the prior-filed application does not provide support for “the hierarchical resolution of the difference between the first between the first operational threshold and the second operational threshold comprises: one or more past solutions to the difference between the first operational threshold and the second operational threshold; and determining, a solution to the difference between the first operational threshold and the second operational threshold based on the one or more past solutions.” Examiner cannot find disclosure or suggestion of the hierarchical resolution of the difference between the first between the first operational threshold and the second operational threshold comprises: one or more past solutions to the difference between the first operational threshold and the second operational threshold; and determining, a solution to the difference between the first operational threshold and the second operational threshold based on the one or more past solutions. Accordingly, claims 21-38 and 41-42 are not entitled to the benefit of the prior applications.
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.
The claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of the patent eligible subject matter because the broadest interpretation of the computer-readable medium of claims 35-36 and 38 encompasses signals per se.
Claims 28-29, 31-36, and 38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process (claims 28-29 and 31-34).
INDEPENDENT CLAIMS
Step 2A Prong 1
Claim 28 recites steps of
a surgical hub comprising a one or more processors;
wherein the one or more processors are configured to:
obtaining a first contextual dataset from one or more data sources;
determining, based on a machine learning system, that the first contextual dataset is relevant to adjusting the parameter of the surgical instrument, wherein the machine learning system correlates one or more of patient record data, patient monitoring data, and modular device data to determine the relevancy, and wherein the first contextual dataset indicates a first operational threshold;
determine that the first operational threshold is different from a second operational threshold, wherein the second operational threshold is indicated by a second contextual dataset that is relevant to adjusting the parameter;
arranging the first and second contextual datasets in a hierarchy of priority, the hierarchy of priority comprises a primary tier, a secondary tier that is lower in priority than the primary tier, and a tertiary tier that is lower in priority than the secondary tier, such that the first contextual dataset possesses a higher priority than the second contextual dataset and is placed in a tier among the primary, secondary, and tertiary tiers that is a higher priority than where the second contextual dataset is placed;
determining an adjustment value of the parameter based on a hierarchical resolution of the difference between the first operational threshold and the second operational threshold;
generating, via the surgical hub, control instructions that cause the surgical instrument to alter an operation associated with the surgical procedure in accordance with the adjustment value of the parameter
and
sending the control instructions to a robotic system so that the robotic system alters the operation associated with the surgical procedure in accordance with the adjustment value of the parameter of the surgical instrument, wherein the robotic system is communicatively coupled to the surgical hub.
Claim 35 recites similar limitations as claim 21 but for the recitation of generic computer components.
These steps for determining relevancy and adjusting a parameter of a surgical instrument, as drafted, under the broadest reasonable interpretation, includes performance of the limitations in the mind. That is nothing in the claim element precludes the italicized portions from practically being performed in the mind through the determination of an adjustment value of the parameter for a surgical instrument in accordance with the resolved difference. This could be analogized to collecting information, analyzing it, and displaying certain results of the collection and analysis. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components, then it falls within the “Mental Process” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application. In particular, the additional elements, non-italicized portions identified above for claims 28 and 35 do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of based on a machine learning system; via the surgical hub; that cause the surgical instrument to alter an operation; so that the robotic system alters the operation associated with the surgical procedure in accordance with the adjustment value of the parameter of the surgical instrument, wherein the robotic system is communicatively coupled to the surgical hub; and, a computer readable medium comprising instructions that, when executed by a processor, cause the processor to perform operations amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of obtaining a first contextual dataset from one or more data sources; and, sending the control instructions to a robotic system amounts to mere data gathering and output since it does not add meaningful limitations to the obtaining and sending actions performed, see MPEP 2106.05(g))
Each of the above additional elements therefore only amounts to mere instructions to implement functions within the abstract idea using generic computer components or other machines within their ordinary capacity. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. These elements are therefore not sufficient to integrate the abstract idea into a practical application. Therefore, the above claims, as a whole, are directed to an abstract idea.
Step 2B
The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to mere instructions to apply an exception in particular fields such as based on a machine learning system; via the surgical hub; that cause the surgical instrument to alter an operation; so that the robotic system alters the operation associated with the surgical procedure in accordance with the adjustment value of the parameter of the surgical instrument, wherein the robotic system is communicatively coupled to the surgical hub; and, a computer readable medium comprising instructions that, when executed by a processor, cause the processor to perform operations, e.g., a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. v. CLS Bank, MPEP 2106.05(f).
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as recitation of obtaining a first contextual dataset from one or more data sources; and, sending the control instructions to a robotic system; e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i);
Looking at the limitations as an ordered combination adds nothing that is not already
present when looking at the elements taken individually. There is no indication that the
combination of elements improves the functioning of a computer or improves any other
technology. Their collective functions merely provide generic computer implementation.
DEPENDENT CLAIMS
Step 2A Prong 1
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 29, 31-34, 36, and, 38 recite particular aspects for determining relevancy and adjusting a parameter of a surgical instrument such as
[Claim 29 & 36] wherein the first contextual dataset comprises a first constraint, wherein the second contextual dataset comprises a second constraint, and wherein the one or more processors are further configured to generate a third constraint that satisfies the first constraint and the second constraint;
[Claim 31 & 38] wherein the method further comprises obtaining a third contextual dataset at the same or higher tier than the first contextual dataset, wherein the third contextual dataset comprises data to resolve the difference between the first operational threshold and the second operational threshold;
[Claim 32] wherein the first contextual dataset comprises an exception to refer to a lower tiered contextual dataset under a specific circumstance, wherein the method further comprises determining that under the specific circumstance the first contextual dataset instructs to defer to the second contextual dataset for the adjustment value of the parameter;
[Claim 33] wherein the one or more processors are further configured to inform a user that the difference between the first operational threshold and the second operational threshold cannot be resolved by the surgical hub;
[Claim 34 & 40] wherein the hierarchical resolution of the difference between the first operational threshold and the second operational threshold comprises:
accessing one or more past solutions to the difference between the first operational threshold and the second operational threshold, and
determining a solution to the difference between the first operational threshold and the second operational threshold based on the one or more past solutions;
these italicized portions covers performance of the limitations in the mind but for recitation of generic computer components because they merely further describe the types of data and determinations that can be performed by humans).
Step 2A Prong 2
Dependent claims 29-30, 33, and 36-37 recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (the additional limitations in claims 29, & 36 (the one or more processors are further configured); claim 30, & 37 (the one or more processors are further configured); and, claim 33 (wherein the surgical hub is further configured to inform a user that the difference between the first contextual dataset and the second contextual dataset cannot be resolved by the surgical hub)) amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B
Dependent claims 29-30, 33, and 36-37 recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea, e.g., a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. v. CLS Bank, MPEP 2106.05(f). There is no indication that these additional elements improve the functioning of a computer or improves any other technology. Their collective functions merely provide generic computer implementation.
Therefore, in consideration of all the facts, the present invention is not a patent-eligible invention under USC 101. Additionally, it is evident that the present claims monopolize AI-driven surgical optimization, restricting further innovation in this area without offering a specific, technical improvement to how the computer actually operates. Using AI tools is generally not enough to transform an abstract idea into patent-eligible subject matter if the core of the invention is still a method of determination; “monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it.” Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (quoting Myriad, 569 U.S. at 589, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)).
No USC 101 Rejection
Regarding claims 21-22, 24-27, and 42, the claim does not recite an abstract idea because the limitations recited could not be practically performed by humans or performed mentally. Even if the claims are directed to an abstract idea, the claimed invention as a whole integrates the abstract idea into a practical application by controlling operation of the robotic system configured to manipulate at least one removably coupled surgical instrument through a minimally invasive incision by sending control instructions including the adjusted value to the robotic system which causes the operation of the robotic system to be altered in accordance with the adjustment value. This positions the claims away from reciting any abstract idea. These features go beyond a generic computer implementation of any abstract idea.
Response to Arguments
The arguments filed on 12 August 2026 have been considered, but are not fully persuasive.
Regarding the priority, applicant disagrees with not being entitled to the priority dates if the prior filed applications and states that they will address the priority in later proceedings. Applicant requests reconsideration in light of the amended claims.
Examiner disagrees and asserts that even in light of the amendments, applicant is still not entitled to the priority dates of the prior filed applications. Examiner points out that once a priority claim is challenged, the burden shifts to the applicant to point directly to specific paragraphs, figures, or line numbers to prove that the priority document provides proper disclosure under enablement and written description standards; applicant did not do so. Therefore, applicant is still not entitled to the priority dates of the prior filed applications.
Regarding the USC 101 rejection, applicant states that they’ve amended claims 21, 28, and 35 to incorporate one or more features of claim 41. Applicant requests reconsideration and withdrawal of the USC 101 rejection.
Examiner partly disagrees because while claim 21 and its dependents are no longer rejected under USC 101. Claims 28 and 35 do not recite all the limitations from claim 41. It is not clear what the surgical procedure or adjustment value represents for the operation of the robotic system to be altered. Therefore, the US 101 rejection has been maintained for claims 28 and 35 and their respective dependents.
Regarding the USC 103 rejection, while the references of record are understood to be the closest prior art, the scope of the claim(s) has been clarified to describe a particular manner in which arrange the first and second contextual datasets in a hierarchy of priority, the hierarchy of priority comprises a primary tier, a secondary tier that is lower in priority than the primary tier, and a tertiary tier that is lower in priority than the secondary tier, such that the first contextual dataset possesses a higher priority than the second contextual dataset and is placed in a tier among the primary, secondary, and tertiary tiers that is a higher priority than where the second contextual dataset is placed; and, send the control instructions to the robotic system so that the robotic system alters the operation associated with the surgical procedure in accordance with the adjustment value of the parameter of the surgical instrument. This goes beyond any teachings or suggestions in the art. Therefore, the USC 103 rejection has been withdrawn.
Prior Art Cited but Not Relied Upon
Franke, S., Rockstroh, M., Hofer, M., & Neumuth, T. (2018). The intelligent OR: design and validation of a context-aware surgical working environment. International Journal of Computer Assisted Radiology and Surgery, 13, 1301-1308.
This reference is relevant because is discloses an intelligent surgical working environment for endoscopic ear–nose–throat surgery.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WINSTON FURTADO whose telephone number is (571)272-5349. The examiner can normally be reached Monday-Friday 8:00 AM to 4:00 PM EST.
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/WINSTON R FURTADO/Primary Examiner, Art Unit 3687
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