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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 ----4/7/2026 has been entered.
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.
Claims 1-2, 5, 8, 10, 12-13, 16, and 19-20 have been rejected.
Information Disclosure Statement
The information disclosure statement filed 4/7/2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
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 have been amended to disclose, “generate anonymized health data by processing the health data using the security key…” While para 123 discloses, “the consent may be associated with the data in the form of a key…” it does not disclose, “generating anonymized health data by processing the health data using the security key.” Paras 151-152 disclose, “the surgical data management system 53000 may remove patient identifying data from the patient’s health data when sending the requested data,” and, “A subset of patient data is removed to maintain patient anonymity for the processing of the data,” thus discloses, “generating anonymized health data by… removing patient identifying data…” However, there is no support for, “generating anonymized health data by processing the health data using the security key.”
Dependent claims are rejected as dependent on a rejected base claim.
Thus, 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.
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 a use of anonymized health data; generate anonymized health data by processing the health data using the security key and removing patient identifying data from the processed 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, permit use of the anonymized health data in accordance with the conditional consent, based on a condition that the number of datasets similar to the anonymized health data is less than the threshold, block access to the anonymized health data, and upon permitting use of the anonymized health data, generate a control program update for a surgical instrument based on the anonymized health data, and send the control program update to the surgical instrument to control the surgical instrument.
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 a use of anonymized health data; generating anonymized health data by processing the health data using the security key and removing patient identifying data from the processed 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, permitting use of the anonymized health data in accordance with the conditional consent, 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, and upon permitting use of the anonymized health data, generate a control program update for a surgical instrument based on the anonymized health data, and send the control program update to the surgical instrument to control the surgical instrument.
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 based on permitting use of anonymized health data or block access to data wherein the data is permitted or blocked 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
A data requesting system
A secure database
A security key associated with the conditional consent and used to process health data
Send the control program update to the surgical instrument to control the surgical instrument
Independent Claim 12 discloses the following additional elements:
A data requesting system
A secure database
A security key associated with the conditional consent and used to process health data
Send the control program update to the surgical instrument to control the surgical instrument
In particular, the processor, data requesting system, secure database, and the security key associated with the conditional consent and used to process health data 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.
The Examiner further notes that the change to the control program that is associated with a surgical instrument is not clearly claiming that the surgical instrument is actually controlled based on the anonymized health data. It is only claimed that the control program is changed and then sent to the surgical instrument (with the intent to control the surgical instrument), not that the control program is implemented on the surgical instrument. There is no disclosure of how the control program would specifically be changed based on the anonymized health data as such there is no disclosure of how the surgical instrument control program would be “improved”. The claim does not disclose how any specific anonymized health data will specifically change the control program. Therefore, the control program update is not necessarily modifying how the surgical instrument operates and instead may merely be some form of data transmission with data analysis. 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. Further, the claim does not actively disclose that the surgical instrument then runs using the “control program update.” The claim merely discloses sending the control program and, thus, merely discloses transmitting data to the surgical instrument.
As such, “sending the control program update to the surgical instrument to control the surgical instrument” amounts to insignificant extra-solution activity as further discussed below.
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 independent claims disclose 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, thus, would have nothing to do with the surgical instrument.
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, and the security key associated with the conditional consent used to decrypt health data 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").
Further, “sending the control program update to the surgical instrument to control the surgical instrument” was considered insignificant extra-solution activity in Step 2A, Prong 2. Re-evaluating here in step 2B, these are also determined to be well-understood, routine, conventional activity in the field. MPEP 2106.05(g) discloses that the courts have recognized the receiving or transmitting data over a network as well-understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (See: Symantec, 838 F.3d at 1321, `10 USPQ2d at 1362; TLI Communications LLC v. AV Auto. LLC; OIP Techs., Inc., v. Amazon.com, Inc.; and buySAFE, Inc. v. Google, Inc.).
Accordingly, when considering the additional elements alone, and in combination, these additional elements 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 based on a condition that the number of datasets similar to the anonymized health data equals or exceeds the threshold, permit use of the anonymized health data in accordance with the conditional consent, and based on a condition that the number of datasets similar to the anonymized health data is less than the threshold, bock access to the anonymized health data and upon permitting use of the anonymized health data, generate a control program update for a surgical instrument based on the anonymized health data, and send the control program update to the surgical instrument to control the surgical instrument, 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 4/7/2026 with respect to 35 U.S.C. § 112(a) have been fully considered.
While the previous 112(a) related to “decrypting” has been withdrawn in the light of the removal of “decrypting” or “decrypted data” from the claim, the Applicant argues that the amendment of “processing” in replacement of “decrypting” has support in paragraphs 122-123 and 151-152. The Examiner respectfully disagrees. While para 123 discloses, “the consent may be associated with the data in the form of a key…” it does not disclose, “generating anonymized health data by processing the health data using the security key.” Paras 151-152 disclose, “the surgical data management system 53000 may remove patient identifying data from the patient’s health data when sending the requested data,” and, “A subset of patient data is removed to maintain patient anonymity for the processing of the data,” thus discloses, “generating anonymized health data by… removing patient identifying data…” However, the specification does not disclose, “generating anonymized health data by processing the health data using the security key.” Therefore, this argument is not persuasive and the 112(a) rejection has been updated above in light of the amendments.
The Applicant further amended the claim 1 in light of the previous 112(a) rejection relating to the threshold/control program linkage. The Applicant has amended claims 1 and 12 to now read, “based on a condition that the number of datasets similar to the anonymized health data equals or exceeds the threshold, permit use of the anonymized health data in accordance with the conditional consent, and upon permitting use of the anonymized health data, generate a control program update for a surgical instrument based on the anonymized health data, and send the control program update to the surgical instrument to control the surgical instrument.” Based on these amendments, the previous 112(a) rejection has been withdrawn as the claim no longer discloses, “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.”
Applicant’s arguments filed 4/7/2026 with respect to 35 U.S.C. § 101 have been fully considered, but are not persuasive.
The Applicant argues that the claims do not recite a certain method of organizing human activity. The Examiner respectfully disagrees. MPEP 2106. 04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that the identified claim elements represent a series of rules or instructions that a person or persons, with or without the aid of a computer, would follow to determine whether to provide a change to a control program based on permitting use of anonymized health data or block access to data wherein the data is permitted or blocked based on the amount of datasets similar to anonymized health data. Applicant has not pointed to anything in the claims that fall outside of this characterization. Limitation (1) discloses a secure database and security key associated with a conditional consent which was found above to be 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. Limitation (2) broadly discloses using the security key which is 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. The remaining portion of limitation (2) and limitations (3) and (4) were found to be a part of the abstract idea. In regards to limitation (5), the limitation is broadly claimed and generating the control program update was classified as a part of the abstract idea because control program update is broadly claimed and could merely represent a person providing a change to a program manually after determining that the use of the health data was permitted. Sending the control program update to the surgical instrument to control it is also broadly claimed as there is no explanation in the claims of what the control program entails and therefore is not necessarily modifying how the surgical instrument operates and instead may merely be some form of data transmission with data analysis. As presented above, this limitation was found to amount to insignificant extra-solution activity. Because the claim elements identified above under the 101 rejection (the non-bolded limitations) fall under a series of rules or instructions that a person or persons would follow to determine whether to provide a change to a control program based on permitting use of anonymized health data or block access to data wherein the data is permitted or blocked based on the amount of datasets similar to anonymized health data, the claimed invention is directed to an abstract idea.
The Applicant then cited the 2019 PEG Update at Section I.C.i (p. 7) and stated “’a specific data encryption method for computer communication involving a several-step manipulation of data’ as an example of a claim that does not recite an abstract idea, because such operations cannot practically be performed in the human mind.” The Examiner notes that the section cited is specifically discussing if the claims recite a mental process. The claim in question solely recited the specific data encryption method that could not be performed in the human mind and did not recite any limitations otherwise directed to a different judicial exception, such as certain methods of organizing human activity. 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. As such, this argument cannot be persuasive.
The Applicant argues further that the “security-key-based processing, threshold-based anonymity verification, and surgical instrument control program generation are similarly technical operations that do not recite a CMOHA” in regards to Section I.C.I (p. 7). However, this section specifically discusses why certain claims are not directed to mental processes, and therefore this argument is not persuasive in regards to determining if a claim recites a certain method of organizing human activity. Since the claims are directed to certain methods of organizing human activity, the comparison of the claims of the instant application to the claims that are not directed to a mental process that are discussed in section I.C.i (p. 7) of the 2019 PEG Update is not persuasive.
The Applicant further argues that the claims integrate any judicial exception into a practical application. Specifically, the Applicant points to Example 42. The Examiner disagrees that the claims of the instant application are analogous to the claims discussed in Example 42. Example 42 analyzed claims directed to network-based patient management method that collects and consolidates patient health information from various providers, converts data into a standardized format, stores it in network-based storages devices, and automatically generates and transmits real-time notification to healthcare providers. The claims of the instant application to not recite anything similar to the limitations of the claims analyzed in Example 42. The Applicant claims that the claims are analogous because they believe the amended claims of the instant application “recite a combination of specific technical elements that integrate any alleged CMOHA into a practical application,” and points to 4 specific limitations. Limitation (1) discloses a secure database and security key associated with a conditional consent which was found above to be 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. Limitation (2) broadly discloses using the security key which is 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. The remaining portion of limitation (2) and limitation (3) were found to be a part of the abstract idea. In regards to limitation (4), the limitation is broadly claimed and generating the control program update was classified as a part of the abstract idea because control program update is broadly claimed and could merely represent a person providing a change to a program manually after determining that the use of the health data was permitted. Sending the control program update to the surgical instrument to control it is also broadly claimed as there is no explanation in the claims of what the control program entails and therefore is not necessarily modifying how the surgical instrument operates and instead may merely be some form of data transmission with data analysis. As presented above, this limitation was found to amount to insignificant extra-solution activity. The claims do not present any additional elements that implement the abstract idea into a practical application. The Applicant argues that the claims disclose “specific data-security and machine-control operations that, taken together, provide a concrete technical solution to a concrete technical problem.” The Examiner respectfully disagrees. MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicates that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014) (finding that claiming a website that retained the “look and feel” of a host webpage provided a technological solution to the problem of retention of website visitors by utilizing a website descriptor that emulated the “look and feel” of the host webpage, where the problem arose out of the internet and was thus a technical problem). Here, the Applicant’s argued problem is not a technological problem caused by the processor, the technological environment to which the claims are confined. The problem of needing to determine when to give access to health data based on patient conditional consent and the number of similar data sets was not a problem caused by the processor that is involved in the process. At best, Applicant’s identified problem is a business problem. Because no technological problem is present, the claims do not provide a practical application.
The Applicant further argues that, “the claimed system allows aggregated patient health data to improve surgical instrument performance while preserving patient anonymity through security-key based processing and threshold gated access.” The Examiner respectfully disagrees. The 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 the claim results in improving surgical instrument performance is not reflected in the claimed invention. There is no disclosure of how the control program would specifically be changed based on the anonymized health data as such there is no disclosure of how the surgical instrument control program would be “improved”. The claim does not disclose how any specific anonymized health data will specifically change the control program. Therefore the control program update is not necessarily modifying how the surgical instrument operates and instead may merely be some form of data transmission with data analysis. 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. Further, the claim does not actively disclose that the surgical instrument then runs using the “control program update.” The claim merely discloses sending the control program and thus merely discloses transmitting data to the surgical instrument, which was classified as insignificant extra-solution activity, which does not provide an improvement to a computer or any other technology/technical field, and thus does not integrate the abstract idea into a practical application.
The Applicant again argues that the technical limitations cannot practically be performed in the human mind and “acknowledges that the Examiner characterized the claims under CMOHA rather than as a mental process. However, regardless of the grouping, the 2019 PEG Update at Section I.C.i (p. 7) instructs that ‘[c]laims do not recite a mental process when they do not contain limitations that can practically be performed in the human mind.’” The Examiner respectfully disagrees that this statement holds regardless of the grouping. The section specifically discusses in detail the “mental processes” grouping and even specifically says “claims do not recite a mental process when…” in the quote cited by the Applicant. Just because a claim does not contain limitations that can practically be performed in the human mind does not automatically mean that the claim cannot be directed to another grouping of a judicial exception such as a mathematical concept or certain methods of organizing human activity. The Applicant argues further that the “security-key-based processing, threshold-based anonymity verification, and surgical instrument control program generation are similarly technical operations that do not recite a CMOHA” in regards to Section I.C.I (p. 7). However, this section specifically discusses why certain claims are not directed to mental processes, and therefore this argument is not persuasive in regards to determining if a claim recites a certain method of organizing human activity. Since the claims are directed to certain methods of organizing human activity, the comparison of the claims of the instant application to the claims that are not directed to a mental process that are discussed in section I.C.i (p. 7) of the 2019 PEG Update is not persuasive. The use of the security key was found to be 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. Removing patient identifying data from processed health data and determining and comparing a threshold number of datasets were found to be a part of the abstract idea of certain methods of organizing human activity (and not a mental process as the Applicant repeatedly argues). Generating the control program update was classified as a part of the abstract idea because control program update is broadly claimed and could merely represent a person providing a change to a program manually after determining that the use of the health data was permitted. Sending the control program update to the surgical instrument to control it is also broadly claimed as there is no explanation in the claims of what the control program entails and therefore is not necessarily modifying how the surgical instrument operates and instead may merely be some form of data transmission with data analysis. As presented above, this limitation was found to amount to insignificant extra-solution activity.
Conclusion
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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/SARA JESSICA MORICE DE VARGAS/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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