DETAILED ACTION
Response to Amendment
This action is in response to the amendment filed on July 9, 2025. Claims 1 and 10 have been amended. Claims 1, 4-10, and 13-20 have been examined and are currently pending.
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 .
Inventorship
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim Rejections - 35 USC § 112
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, 4-10, and 13-20 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 10 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. Independent claims 1 and 10 recite the limitation, “select, via a data management module, a region-specific rule set based on the region-based consent requirement” is not supported within the applicant’s specification. Paragraph 00109 of the applicant’s specification discloses, “The surgical data system 45002 may include a data management module 45006. The data management module 45006 may provide management of a data stream, and/or an organization and structure of the data stream, for example, to facilitate an integration of the data stream into a database or multiple databases. The data management module 45006 may provide management of a data stream, and/or an organization and structure of the data stream, for example, by selecting one or more tule sets from rule sets 45008. The rule sets 45008 may be generated via rule set creation 45012…” Paragraph 00109 discloses selecting one or more rule sets but does not disclose selecting a region-specific rule set based on region-based consent requirement.
Claims 1 and 10 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. Independent claims 1 and 10 recite the limitation, “based on the region-specific rule set and the patient consent data, generate a region-compliant dataset by obfuscating an unauthorized data element of the dataset” is not supported within the applicant’s specification. Paragraph 00109 of the applicant’s specification discloses, “The surgical data system 45002 may include a data management module 45006. The data management module 45006 may provide management of a data stream, and/or an organization and structure of the data stream, for example, to facilitate an integration of the data stream into a database or multiple databases. The data management module 45006 may provide management of a data stream, and/or an organization and structure of the data stream, for example, by selecting one or more tule sets from rule sets 45008. The rule sets 45008 may be generated via rule set creation 45012…” Paragraph 00109 discloses a region-specific rule set but does not disclose generating a region-compliant dataset by obfuscating an unauthorized data element of the dataset.
Claims 1 and 10 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. Independent claims 1 and 10 recite the limitation, “generate a control signal based on the determining, wherein the control signal is configured to indicate to display the region-compliant data set.” is not supported within the applicant’s specification. Paragraph 0067 of the applicant’s specification discloses, “Applying cloud computer data processing techniques on the measurement data collected by the sensing systems 20069, the surgical data network can provide improved surgical outcomes, improved recovery outcomes, reduced costs, and improved patient satisfaction. At least some of the sensing systems 20069 may be employed to assess physiological conditions of a surgeon operating on a patient or a patient being prepared for a surgical procedure or a patient recovering after a surgical procedure. The cloud-based computing system 20064 may be used to monitor biomarkers associated with a surgeon or a patient in real- time and to generate surgical plans based at least on measurement data gathered prior to a surgical procedure, provide control signals to the surgical instruments during a surgical procedure, and notify a patient of a complication during post-surgical period.” Paragraph 0067 discloses control signal, however, it does not disclose generating a control signal based on the determining, wherein the control signal is configured to indicate to display the region-compliant data set.
Claims 1 and 10 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. Independent claims 1 and 10 recite the limitation, “send the control signal to the patient data display interface” is not supported within the applicant’s specification. Paragraph 0067 of the applicant’s specification discloses, “Applying cloud computer data processing techniques on the measurement data collected by the sensing systems 20069, the surgical data network can provide improved surgical outcomes, improved recovery outcomes, reduced costs, and improved patient satisfaction. At least some of the sensing systems 20069 may be employed to assess physiological conditions of a surgeon operating on a patient or a patient being prepared for a surgical procedure or a patient recovering after a surgical procedure. The cloud-based computing system 20064 may be used to monitor biomarkers associated with a surgeon or a patient in real- time and to generate surgical plans based at least on measurement data gathered prior to a surgical procedure, provide control signals to the surgical instruments during a surgical procedure, and notify a patient of a complication during post-surgical period.” Paragraph 0067 discloses control signal, however, it does not disclose send the control signal to the patient display interface.
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, 4-10, and 13-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
ALICE/ MAYO: TWO-PART ANALYSIS
2A. First, a determination whether the claim is directed to a judicial exception (i.e., abstract idea).
Prong 1: A determination whether the claim recites a judicial exception (i.e., abstract idea).
Groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Mathematical concepts- mathematical relationships, mathematical formulas or equations, mathematical calculations.
Certain methods of organizing human activity- fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
Mental processes- concepts performed in the human mind (including an observation, evaluation, judgement, opinion).
Prong 2: A determination whether the judicial exception (i.e., abstract idea) is integrated into a practical application.
Considerations indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception
Considerations that are not indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
2B. Second, a determination whether the claim provides an inventive concept (i.e., Whether the claim(s) include additional elements, or combinations of elements, that are sufficient to amount to significantly more than the judicial exception (i.e., abstract idea)).
Considerations indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception NOTE: The only consideration that does not overlap with the considerations indicative of integration into a practical application associated with step 2A: Prong 2.
Considerations that are not indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. NOTE: The only consideration that does not overlap with the considerations that are not indicative of integration into a practical application associated with step 2A: Prong 2.
See also, 2019 Revised Patent Subject Matter Eligibility Guidance; Federal Register; Vol. 84, No. 4; Monday, January 7, 2019
Claims 1, 4-10, and 13-20 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.
1: Statutory Category
Applicant’s claimed invention, as described in independent claim 1 is directed to a system and independent claim 10 is directed to a method.
2(A): The claim(s) are directed to a judicial exception (i.e., an abstract idea).
PRONG 1: The claim(s) recite a judicial exception (i.e., an abstract idea).
Mental Processes
Independent claims 1 and 10 recite the limitations, “identifying a dataset associated with a patient data display interface; determining a geographic location of a patient data display system where the patient data display interface is to be displayed; determining, using metadata associated with the dataset, a data origin location of the dataset; identifying a relevant controlling region associated with the dataset, wherein the relevant controlling region is identified based at least on the determined geographic location of the patient data display system and the data origin location of the dataset; determining a region-based consent requirement associated with the dataset based on the relevant controlling region; obtaining a patient consent data; selecting, via a data management module, a region-specific rule se based on the region-based consent requirement; determining whether to display the dataset via the patient data display interface based on the determined region-based consent requirement and the obtained patient consent data;” are directed to the abstract idea of mental processes. Specifically, the limitations recited above consists of steps that can performed in the human mind by observation, evaluation, and/or judgment. In particular, the steps refer to determining and interpreting regional based consent requirements of a dataset and determine what to display based on the region-based consent requirements and patient consent data. These steps require observation, evaluation, and judgment of data by a user.
Additionally, under step 2A of “integration into a practical application” requires:
• Improvement to the functioning of a computer, or an improvement to any other technology or technical field
• Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition
• Applying the judicial exception with, or by use of a particular machine.
• Effecting a transformation or reduction of a particular article to a different state or thing
• Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception
The applicant has not shown or demonstrated any of the requirements described above under "integration into a practical application" under step 2A. Specifically, the applicant's limitations are not "integrated into a practical application" because they are adding words "apply it" with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea (see MPEP 2106.05(f)). Additionally, improvements to the functioning of a computer or any other technology or technical field has not been shown or disclosed (see MPEP 2106.05(a)). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Specifically, the applicant’s limitations are not “significantly more” because they are adding words “apply it” with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea (see MPEP 2106.05(f)) and adding insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)). The current application does not amount to 'significantly more' than the abstract idea as described above. The claim does not include additional elements or limitations individually or in combination that are sufficient to amount to significantly more than the judicial exception. Specifically, the individual elements of processor, patient data display interface, and patient data display system add no more than implementing an idea with a computerized system and they are adding words “apply it” with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea and adding insignificant extra solution activity to the judicial exception. The additional elements taken in combination add nothing more than what is present when the elements are considered individually. Therefore, based on the two-part Alice Corp. analysis, there are no meaningful limitations in the claims that transform the exception (i.e., abstract idea) into a patent eligible application.
Dependent claims 4-9 and 13-20 are rejected as ineligible subject matter under 35 U.S.C. 101 based on a rationale similar to the claims from which they depend. The following dependent claims recite the particular elements: Dependent claims 4, 6 and 17-18 recite a processor which do not recite additional elements that amount to significantly more than the judicial exception. Dependent claims 6-9, 15, and 16-18 recite a patient data display interface which do not recite additional elements that amount to significantly more than the judicial exception.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
identify a relevant controlling region associated with the dataset, wherein the relevant controlling region is identified based at least on the determined geographic location of the patient data display system and the data origin location of the dataset;
determine whether to display the dataset via the patient data display interface based on the determined region-based consent requirement and the obtained patient consent data;
Response to Arguments
Applicant's arguments filed July 9, 2025 have been fully considered but they are not persuasive.
According to applicant’s arguments on pages 8-9 of the remarks disclose, “The guidance further explains that one way to demonstrate such integration is when the claims improve computer functionality, another technology, or a technical field. Id. Here, amended claim 1 recites, among other things, "select[ing], via a data management module, a region-specific rule set based on the region-based consent requirement," "based on the region- specific rule set and the patient-consent data, generat[ing] a region-compliant dataset by obfuscating an unauthorized data element of the dataset," "generating a control signal based on the determining, wherein the control signal is configured to indicate to display the region- compliant data set," and "sending the control signal to the patient data display interface." As described in the Specification, these features provide a technological improvement in securely displaying patient data across differing legal jurisdictions by dynamically selecting region-specific rule sets, generating a region-compliant data set through obfuscation, and display control of the region-compliant data set. See, e.g., Specification at paras. [00109]-[00110] (data- management module selecting a region-specific rule set; see also FIG. 8), [00145] and [00151] (obfuscation of unauthorized data elements to generate a region-compliant dataset), and [00104] (generation and sending of a control signal to the patient-data display interface). The selection of region-specific rule sets, redaction of unauthorized data elements, and display control of the region-compliant data set are advancements in privacy and data-management technology that enable computing systems to enforce and comply with regional consent requirements dynamically and automatically, thus improving the overall technical field of cross-border healthcare-data.” The examiner respectfully disagrees.
Under the 2019 Revised Patent Subject Matter Eligibility Guidance, determining whether a claim integrates a judicial exception into a practical application, examiners should consider whether the claimed invention pertains to an improvement in the functioning of the computer itself or any other technology or technical field. Additionally, making this determination, examiners should determine whether there is a technical explanation as to how to implement the invention in the specification and the claim itself reflects the improvement in technology. The recited claims do not recite and reflect an improvement in the technology or technical field as required in the 2019 Revised Patent Subject Matter Eligibility. Specifically, the applicant cites improvements such as selection of region-specific rule sets, redaction of unauthorized data elements, and display control of the region-compliant data but specification and claims do not explain how and why the invention the invention is improved and the technology behind it. In particular, the cited paragraphs 00104, 00109-00110, 00145, and 00151 and Figure 8 do not elaborate on how the invention is improved, but generally describe elements or operations of the invention. With respect to the recited limitations, "select[ing], via a data management module, a region-specific rule set based on the region-based consent requirement," "based on the region- specific rule set and the patient-consent data, generat[ing] a region-compliant dataset by obfuscating an unauthorized data element of the dataset," "generating a control signal based on the determining, wherein the control signal is configured to indicate to display the region- compliant data set," and "sending the control signal to the patient data display interface." do not demonstrate an improvement in technology or computer functionality. The limitations demonstrate standard computer functions with respect to selecting a rule set, obfuscating data element of the dataset, generating control signal to display data set, and sending control signal to the data display interface. Additionally, there is no explicit recitation of a machine(s) performing critical aspects/improvements within the independent method claim. Therefore, the examiner maintains the rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 MATTHEW L HAMILTON whose telephone number is (571)270-1837. The examiner can normally be reached Monday-Thursday 9:30-5:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marc Jimenez can be reached at (571)272-4530. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW L HAMILTON/Primary Examiner, Art Unit 3681