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
Claims 1-2, 5, 8, 10, 12-13, 16, and 19-20 are currently pending and have been examined.
Claims 1-2, 5, 8, 12-13, 16, and 19-20 have been amended.
Claims 3-4, 6-7, 9, 11, 14-15, 17-18, and 21 have been canceled, with claims 3-4, 6-7, 11, 14-15, and 17-18 being newly canceled in the response filed 09/02/2025.
Claims 1-2, 5, 8, 10, 12-13, 16, and 19-20 have been rejected.
Claim Objections
Claim(s) 1 is objected to because of the following informalities: Claim 1 discloses the following typo: “health data associated Appropriate correction is required.
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 1-2, 5, 8, 10, 12-13, 16, and 19-20 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 1 and 12 disclose, “generate anonymized health data by decrypting the health data using the security key.” The Examiner notes that the health data is never described as being encrypted, so it’s not clear what is being “decrypt[ed].” Further, while Para 122 of the Applicant’s specification discloses, “For example, a patient may not necessarily have or need the legal right to consent or revoke consent. In these circumstances, a secondary server, security keys, or access granting or confirming could be on a separate key, system, server, etc. that would be needed in cooperation to the system holding or accessing the data in order to gain access and control aspects of the data,“ there is no disclosure that the security key is used to decrypt the health data. Examiner notes that “granting access” is not the same as “decrypting”. As such, there is no support for generating anonymized health data by decrypting the health data using the security key.
Claims 1 and 12 disclose, “based on a condition that the number of datasets similar to the anonymizedto control a surgical instrument, a surgery planning program, a program configured to control a surgical computing system),” there is no disclosure that the “enhancing a surgical control program” is implemented based on the number of datasets that are similar to the anonymized data. While Para 45-46 of the Applicant’s specification discloses, “The surgical hub 20006, alone or in communication with the cloud computing system, may use the surgeon biomarker measurement data and/or environmental sensing information to modify the control algorithms of hand- held instruments or the averaging delay of a robotic interface, for example, to minimize tremors,” there is no disclosure of changing a control program based on the number of datasets that are similar to the anonymized data. As such, there is no support for, “based on a condition that the number of datasets similar to the anonymized
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, 5, 8, 10, 12-13, 16, and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to an abstract idea without significantly more. Claims 1-2, 5, 8, 10, 12-13, 16, and 19-20 are directed to a system, method, or product which are one of the statutory categories of invention. (Step 1: YES).
Independent Claim 1 discloses a surgical data management system, comprising: a processor configured to: receive a data request for health data associated with a patient from a data requesting system; obtain, from a secure database, a conditional consent associated with the patient, a security key associated with the conditional consent, and the health data; identify a condition associated with the conditional consent; determine that the condition indicates that the patient consents to the use of anonymized health data; generate anonymized health data by decrypting the health data using the security key and removing patient identifying data from the decrypted health data; determine a threshold specifying a minimum number of datasets similar to the anonymized health data to preserve anonymity; determine a number of datasets similar to the anonymized health data; and compare the number of datasets similar to the anonymized health data to the threshold, wherein: based on a condition that the number of datasets similar to the anonymized health data equals or exceeds the threshold, provide a change to a control program based on the anonymized health data, wherein the control program is associated with a surgical instrument, and based on a condition that the number of datasets similar to the anonymized health data associated is less than the threshold, block access to the anonymized health data.
Independent Claim 12 discloses a method for surgical data management, the method comprising: receiving a data request for health data associated with a patient from a data requesting system; obtaining, from a secure database, a conditional consent associated with the patient, a security key associated with the conditional consent, and the health data; identifying a condition associated with the conditional consent; determining that the condition indicates that the patient consents to the use of anonymized health data; generating anonymized health data by decrypting the health data using the security key and removing patient identifying data from the decrypted health data; determining a threshold specifying a minimum number of datasets similar to the anonymized health data to preserve anonymity; determining a number of datasets similar to the anonymized health data; and comparing the number of datasets similar to the anonymized health data to the threshold, wherein the method further comprises: based on a condition that the number of datasets similar to the anonymized health data equals or exceeds the threshold, providing a change to a control program based on the anonymized health data, wherein the control program is associated with a surgical instrument, and based on a condition that the number of datasets similar to the anonymized health data is less than the threshold, blocking access to the anonymized health data.
The examiner is interpreting the above bolded limitations as additional elements as further discussed below. The remaining un-bolded limitations are merely directed to determining whether to provide a change to a control program or block access to data based on the amount of datasets similar to anonymized health data. The series of steps recited above describe managing personal behavior or relationships or interactions between people and thus are grouped as certain methods of organizing human activity which is an abstract idea. (Step 2A- Prong 1: YES. The claims are abstract).
This judicial exception is not integrated into a practical application. Limitations that are not indicative of integration into a practical application include: (1) 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 (MPEP 2106.05.f), (2) Adding insignificant extra- solution activity to the judicial exception (MPEP 2106.05.g), (3) Generally linking the use of the judicial exception to a particular technological environment or field of use (MPEP 2106.05.h).
Independent Claim 1 discloses the following additional elements:
A processor
Data requesting system
A secure database
A security key associated with the conditional consent, and the health data… decrypting the health data using the security key
A control program associated with a surgical instrument
Independent Claim 12 discloses the following additional elements:
Data requesting system
A secure database
A security key associated with the conditional consent, and the health data… decrypting the health data using the security key
A control program associated with a surgical instrument
In particular, the processor, data requestion system, secure database, security key used to decrypt health data, and control program associated with a surgical instrument are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception. Applicant’s specification at Paragraphs 52-59 discloses - The computer system 20063 may comprise a processor and a network interface 20100. The processor may be coupled to a communication module, storage, memory, non-volatile memory, and input/output (I/O) interface via a system bus. The system bus can be any of several types of bus structure(s) including the memory bus or memory controller, a peripheral bus or external bus, and/or a local bus using any variety of available bus architectures including, but not limited to, 9-bit bus, Industrial Standard Architecture (ISA), Micro-Charmel Architecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer Systems Interface (SCSI), or any other proprietary bus. The processor may be any single-core or multicore processor such as those known under the trade name ARM Cortex by Texas Instruments. Para 131 further discloses, “the data request may be received from a data requesting system, such as local machine learning system(s) 53032, surgical control system(s) 53034, surgical instrument(s)/device(s) 53036, edge computing device(s) 53038, remote machine learning system(s) 53042, a cloud-based system in the enterprise cloud 53044 and/or a remote data storage 53046 shown in FIG. 8.” These citations further discloses broadly recited hardware elements that perform a routine function in an expected manner.
Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claim(s) 1 and 12 are directed to an abstract idea(s) without a practical application. (Step 2A-Prong 2: NO: the additional claimed elements are not integrated into a practical application).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim does 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 the processor, data requestion system, secure database, security key used to decrypt health data, and control program associated with a surgical instrument amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more' ). MPEP2106.05(I)(A) indicates that merely saying "apply it” or equivalent to the abstract idea cannot provide an inventive concept ("significantly more").
Accordingly, when considering the additional elements alone, and in combination, these additional element do not provide significantly more. As such the independent claims 1 and 12 are not patent eligible. (Step 2B: NO. The claims do not provide significantly more).
Dependent Claims 2, 5, 8, 10, 13, 16, and 19-20 further define the abstract idea that is presented in the respective Independent Claims 1 and 12 and are further grouped as certain methods of organizing human activity and are abstract for the same reasons and basis as presented above.
Dependent claim(s) 2, 5, 8 and 10 further narrow the abstract idea presented in independent claim 1 and/or claims it depends on with no recitation of any further additional elements.
Dependent claim(s) 13, 16 and 19-20 further narrow the abstract idea presented in independent claim 12 and/or claims it depends on with no recitation of any further additional elements.
No further additional hardware components other than those found in the respective independent claims are recited, thus it is presumed that the claims are further utilizing the same generic systemization as presented above. The dependent claims do not include any additional elements that integrate the abstract idea into a practical application of the exception or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination.
Therefore, the dependent claims are also directed to an abstract idea.
Thus, Claims 1-2, 5, 8, 10, 12-13, 16, and 19-20 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Free of Prior Art
Claims 1-2, 5, 8, 10, 12-13, 16, and 19-20 are subject matter free of prior art. The following references are relevant to the subject matter in claims 1-2, 5, 8, 10, 12-13, 16, and 19-20.
Livesay (US PG Pub 2019/0348158 A1) discloses receiving a data request for health data associated with a patient – a query can include information related to the type of health information that the organization would like permission to share (consent) with request parameters, obtaining and identifying a condition associated with the conditional consent, and generating a response to the query indicating if the data sharing organization is authorized to share the health information based on conditions of the consent (type of health information, validity – Para 73-75). Livesay further discloses examining information stored in the entries of the consent directive ledger 180 that correspond to the patient (a plurality of conditional consent ‘entries’ (Para 73) and capturing the most appropriate consent information (Para 45)). Further, Para 66-67 disclose multiple conditions for consent as well as a period of time for consent.
Soong (US Patent 6,941,271 B1) discloses allowing access for information associated with diagnosis or treatment (Column 12, lines 10-13).
Malhotra (US PG Pub 2018/0211010 A1) further discloses earlier surgery recommendation [enhancing surgical control] in Para 4 and authentication and authorization for accessing EMR data (Para 101-103) and a predictive computerized model.
Saddiqi (US PG Pub 2009/0240681A1) discloses geographic locations of client computer systems authorized to access medical records via the medical records network (Para 16). Para 31 further utilizes the physical location of the client computer system. Thus, determining when to share information based on location (privacy protection boundary).
Moriarty (US PG Pub 2013/0194092 A1) discloses if the patient is unable to perform the pre-defined patient action (e.g. the patient is unconscious) then the consent to unlock body area networks for emergency workers may be implied and automatically unlock itself (Para 6 and 51).
Further, Friedlander (US Patent 8,566,113 B2) discloses allowing access to a defined set of patient records where access provides a threshold level of anonymity
Goyal (US PG Pub 2016/0232304) discloses the step of displaying prioritized data in distinct categories, where each category has a threshold for display of prioritized data in a specific category based on the pre-set rules. Where it does not display specific data unless it reaches a priority threshold.
However, there is no combination of prior art that teaches a threshold specifying a minimum number of datasets similar to the anonymized health data to preserve anonymity wherein a change to a control program is provided based on anonymized health data wherein the control program is associated with a surgical instrument if the number of datasets similar to the anonymized data is equal to or exceeds the threshold or access to the anonymized health data is blocked if the number of datasets similar to the anonymized data is less than the threshold as disclosed by claims 1 and 12. Para 141 of the Applicant’s specification discloses, “a condition may include a limitation. For example, whether to activate a patient's consent may be determined based on a minimum number of data points requirement. Requiring a minimum number of data points in the data set for granting access to patient data may enable a patient to control when their data may be used. This may prevent their data from identifying them individually out of a group, thus balancing useful data analysis with privacy issues.”
Response to Arguments
Applicant’s arguments filed 09/02/2025 with respect to 35 U.S.C. § 101 have been fully considered, but are not persuasive. Applicant argues the claim 1 is not directed to an abstract idea because it recites at least a feature that cannot be practically performed in the human mind. The Examiner submits that the abstract idea was not characterized as being directed to a mental process. The claimed invention was characterized as falling under Certain Methods of Organizing Human activity (see Non-Final Office Action dated 06/02/2025 at section 19 on page 6). As such, this argument cannot be persuasive.
The Applicant further argues that claim 1 is not directed to an abstract idea because it is directed towards a particular machine under MPEP 2106.05(b). Examiner respectfully disagrees and notes that MPEP 2106.05(b) discloses, “examiners should consider whether the judicial exception is applied with, or by use of, a particular machine. ‘The machine-or-transformation test is a useful and important clue, and investigative tool’ for determining whether a claim is patent eligible under § 101. Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010). It is noted that while the application of a judicial exception by or with a particular machine is an important clue, it is not a stand-alone test for eligibility. Id… if a claim fails the Alice/Mayo test (i.e., is directed to an exception at Step 2A and does not amount to significantly more than the exception in Step 2B), then the claim is ineligible even if it passes the M-or-T test.” Further, MPEP 2106.05(b)(I) discloses, “it is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine… Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. ” Claim 1 of the instant application recites a surgical data management system comprising a processor configured to perform the method steps. There is no particularity of the surgical data management system, it is a generic processor performing the method steps as expected. Further, as presented above, the claims of the instant application do not amount to significantly more than the exception in Step 2B. As such, the claims of the instant application do not disclose a particular machine (the system comprises a processor alone without any particularity claimed) and are not eligible under 35 U.S.C 101 (the claims do not amount to significantly more or a practical application).
The Applicant further argues that the invention provides a particular way of accomplishing the result, not generic instruction to “apply it.” Obtaining conditional consent, security key, and health data (receiving data) and anonymizing health data is not a particular way of accomplishing the result (anonymizing data with a security key). The surgical data management system comprising a processor is receiving and anonymizing health data as expected. Further, comparing the amount of data to a threshold and providing a change to a control program if the number of datasets similar to the anonymized health data equals or exceeds the threshold (comparing data to a threshold) is not a particular way to accomplish the result. The Examiner notes that the change to the control program that is associated with a surgical instrument is not clearly claiming that the surgical instrument is controlled based on the number of datasets similar to the anonymized health data. It is only claimed that the control program is changed and associated with the surgical instrument, not that the control program is implemented on the surgical instrument. Further, there is an embodiment where the surgical instrument regardless would not be controlled, even if the control program was implemented on the surgical instrument, as the last limitation of claim 1 discloses that the system would only block access to the anonymized health data if the number of datasets similar to the anonymized health data is less than the threshold.
Further, the Applicant argues that claim 1 is not directed to an abstract idea because it claims a specific technical improvement to surgical instrument control programs while preserving privacy and cites the 2025 USPTO memo. Looking at the citation as a whole, the 2025 USPTO memo discloses, ”an important consideration in determining whether a claim improves technology or a technical field is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome.” As such, the memo cites the need for an improvement to a technology or a technical field. Examiner notes that there is an embodiment where the control program would not be changed at all, as the last limitation of claim 1 discloses that the system would only block access to the anonymized health data if the number of datasets similar to the anonymized health data is less than the threshold (and not change the control program). In this regard, there is no improvement to another technology if the amount of datasets similar is to the anonymized health data is less than the threshold.
Further, MPEP 2106.04(d)(1) states “the word ‘improvements’ in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.” Here, there is no improvement to the computer (a processor) nor is there an improvement to another technology. Because neither type of improvement is present in the claims, an improvement to technology is not present and there is no practical application. Applicant’s argument that claim 1 provides a specific technical improvement to surgical instrument control programs is not reflected in the claimed invention. There is no disclosure of how the control program would be changed based on the amount of datasets similar to the anonymized health data equaling or exceeding the threshold as such there is no disclosure of how the control program would be “improved”. The amount of similar datasets is not improving the “other technology” that the Applicant claims is the control program, rather it is simply providing a change to the control program. It is not clearly claimed if the surgical instrument that is associated with the control program is made to run faster, more efficiently, or is improved in some other way.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SARA J MORICE DE VARGAS whose telephone number is (703)756-4608. The examiner can normally be reached M-F 8:30-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H. Choi can be reached on (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA JESSICA MORICE DE VARGAS/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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