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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 25 May 2026 has been entered.
Formal Matters
Applicant's response, filed 25 May 2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 1-10 and 12-20 are currently pending and have been examined.
Claims 1-4, 6-8, 10, and 12-20 have been amended.
Claim 11 has been canceled.
Claims 1-10 and 12-20 have been rejected.
Priority
The instant application does not claim the benefit of priority under 35 U.S.C 119(e) or under 35 U.S.C. § 120, 121, or 365(c) to any prior applications. Accordingly, the effective filing date for the instant application is 18 May 2022.
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.
Claim 7 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims 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, at the time the application was filed, had possession of the claimed invention. Claim 7 recites “determine whether an amount of time associated with the current surgical procedure step has passed” however the instant specification only notes that the redaction may be automated according to “whether an amount of time has passed” generally (see the instant specification in ¶ 0146) without any reference to a relation of the time to a procedure step.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Makrinich et al. (US Patent App No 2021/0313052)[hereinafter Makrinich] in view of Shelton et al. (US Patent App No 20190207773)[hereinafter Shelton].
As per claim 1, Makrinich teaches the following:
a surgical computing system comprising a processor configured to is taught in the Detailed Description in ¶ 0084, ¶ 0322 (teaching on a surgical procedure data database saved on a central processor corrected to remote servers for query);
obtain surgical procedure data associated with a patient wherein the surgical procedure data is obtained during a current surgical procedure step is taught in the Detailed Description in ¶ 0171, ¶ 0069-70, ¶ 0072-73, ¶ 0084-85, and ¶ 0216-217 (teaching on receiving surgical procedure data from a plurality of sensors in a plurality of operating rooms including sound, video, and surgical tool feeds and patient characteristic data to form a database as well as data from a current surgery);
annotate the surgical procedure data with surgical context data to generate annotated surgical procedure data is taught in the Detailed Description in ¶ 0089, ¶ 0094-96, and in the Figures at fig. 6 (teaching on labeling each surgical procedure data set in the database and classifying said data set into event categories);
determine, based on the annotated surgical procedure data, a subsequent surgical procedure step and a surgical instrument associated with the subsequent surgical procedure step is taught in the Detailed Description in ¶ 0097, ¶ 0102, ¶ 0109, ¶ 0171, ¶ 0176, ¶ 0216-217, and in the Figures at fig. 9 (teaching on querying the database for a particular category in order to perform a particular task related to the category - here to analyze a current surgery and determine if the surgery has deviated from a plan and a subsequent task specifically for a particular medical instrument/intra-surgical user device (treated as synonymous to a surgical instrument) );
determine a data need associated with the subsequent surgical procedure step is taught in the Detailed Description in ¶ 0097, ¶ 0102, ¶ 0109, ¶ 0176, and in the Figures at fig. 9 (teaching on querying the database for a particular category in order to perform a particular task related to the category - here to analyze a current surgery and determine if the surgery has deviated from a plan );
wherein the data need comprises data to be used by the surgical instrument to adjust an operational parameter associated with a surgical task in the subsequent surgical procedure step is taught in the Detailed Description in ¶ 0089, ¶ 0094-96, ¶ 0217, ¶ 0301, and in the Figures at fig. 6 (teaching on the target remote processor being a remote intra-surgical user device (treated as synonymous to a surgical instrument) and the task being a next operation step using the user device);
determine a subset of the annotated surgical procedure data based on the data need is taught in the Detailed Description in ¶ 0097, ¶ 0102, ¶ 0109, ¶ 0176-178, and in the Figures at fig. 9 (teaching on the remote processor (treated as synonymous to the target system) querying the database for a particular category in order to perform a particular task related to the category - here to analyze a current surgery and determine if the surgery has deviated from a plan);
generate a data package that comprises the subset of the annotated surgical procedure data is taught in the Detailed Description in ¶ 0097, ¶ 0109, ¶ 0178, ¶ 0322, and in the Figures at fig. 9 (teaching on the remote processor receiving from the database the query results of the surgical procedure data that meets the categorical value related to the current surgery analysis (treated as synonymous to a target system task));
send, before commencement of the subsequent surgical procedure step, the data package is taught in the Detailed Description in ¶ 0097, ¶ 0109, ¶ 0176-178, ¶ 0322, and in the Figures at fig. 9 (teaching on sending the notification for display on the surgical system's interface wherein the notification is based on the received surgical procedure data related).
Makrinich fails to teach the following; Shelton, however, does disclose:
send, before commencement of the subsequent surgical procedure step, the data package to the surgical instrument, wherein the data package causes the surgical instrument to adjust the operational parameter associated with the surgical task based on the subset of the annotated surgical procedure data is taught in the Detailed Description in ¶ 0323, ¶ 0363, and ¶ 0393 (teaching on analyzing relevant anonymized historical surgical data packages during each step of a surgical procedure to determine an adjustment to a stapler parameter when transecting a fissure).
One of ordinary skill in the art before the effective filing date would combine the relevant data query system for surgical planning of Makrinich with the intraoperation parameter adjustment of a surgical instrument of Shelton as “it would be desirable to monitor data associated with the surgical procedure to enable configuration and operation of instruments used during the procedure to improve surgical outcomes” (Shelton in the Detailed Description in ¶ 0302).
Claims 14 and 20 are rejected under the same rational.
As per claim 2, the combination of Makrinich and Shelton discloses all of the limitations of claim 1. Makrinich also discloses the following:
the surgical computing system of claim 1, wherein the surgical procedure data comprises biometric data of the patient that is obtained during the current surgical procedure step, and is taught in the Detailed Description in ¶ 0349 (teaching on receiving surgical procedure data including patient characteristic data including "particulars of anatomy of the patient" or any anatomical particulars use to characterize a patient (treated as synonymous to biometric data) to form a database - Examiner notes the instant specification does not include details regarding the "biometric data" only that it is "patient specific surgical data" generally in ¶ 0186 and ¶ 0220);
wherein the processor is further configured to: determine the surgical context data based on the biometric data, wherein the surgical context data comprises an indication of the current surgical procedure step in a surgical procedure, and an indication of the surgical task is taught in the Detailed Description in ¶ 0089, ¶ 0094-96, and in the Figures at fig. 6 (teaching on the surgical procedure data set including classification labels (treated as synonymous to surgical context data) wherein the classification labels include (1) an event tag (treated as synonymous to the procedure step) and (2) are related to the task associated with the remote server query).
Claim 15 is rejected under the same rational.
As per claim 3, Makrinich and Shelton discloses all of the limitations of claim 2. Makrinich also discloses the following:
the surgical computing system of claim 2, wherein the data package, when sent to the surgical instrument before commencement of the subsequent surgical procedure step, automatically pre-configures the surgical instrument for use during the surgical task to reduce a delay associated with performing the surgical task is taught in the Detailed Description in ¶ 0097, ¶ 0109, ¶ 0176-178, ¶ 0322, and in the Figures at fig. 9 (teaching on the data package related to the surgical task - Examiner notes that the intended use of reducing a delay does not add meaningful limitations to the claim see MPEP § 2144.07 for more detail regarding art recognized suitability for an intended purpose).
Claim 16 is rejected under the same rational.
As per claim 4, Makrinich and Shelton discloses all of the limitations of claim 1. Makrinich also discloses the following:
the surgical computing system of claim 1, wherein the processor is further configured to determine the data need based on at least one of prioritization data, system utilization data, or hierarchical segmentation information is taught in the Detailed Description in ¶ 0191-192 (teaching on event sequence threshold value (treated as synonymous to prioritization data) determination needed from the analyzing of the surgical procedure database).
As per claim 5, Makrinich and Shelton discloses all of the limitations of claim 2. Makrinich also discloses the following:
the surgical computing system of claim 2, wherein the processor is further configured to determine a risk level based on the biometric data, wherein the data need is further determined based on the risk level is taught in the Detailed Description in ¶ 0191-192 and ¶ 0195 (teaching on event sequence threshold value (treated as synonymous to prioritization data of a predetermined acceptable risk level) determination needed from the analyzing of the surgical procedure database).
As per claim 6, Makrinich and Shelton discloses all of the limitations of claim 1. Makrinich also discloses the following:
the surgical computing system of claim 1, wherein the processor is further configured to: determine a classification associated with a portion of the subset of the annotated surgical procedure data; determine that a condition associated with the current surgical procedure step is satisfied; and based on the condition associated with the current surgical procedure step being satisfied, redact the portion of the subset of the annotated surgical procedure data according to the classification is taught in the Detailed Description in ¶ 0097, ¶ 0102, ¶ 0105-109, ¶ 0176, and in the Figures at fig. 9 (teaching on the remote processor querying the database for a particular category (treated as synonymous to a first subset) in order to perform a particular task related to the category wherein the system would not include (treated as synonymous to redacting) the data of a non-necessary (treated as synonymous to a condition) second category (treated as synonymous to a second subset));
wherein the data package is generated in response to the redaction is taught in the Detailed Description in ¶ 0097, ¶ 0109, ¶ 0176-178, ¶ 0322, and in the Figures at fig. 9 (teaching on sending the notification for display on the surgical system's interface wherein the notification is based on the received surgical procedure data).
Claim 17 is rejected under the same rational.
As per claim 7, Makrinich and Shelton discloses all of the limitations of claim 6. Makrinich also discloses the following:
the surgical computing system of claim 6, wherein the processor is further configured to determine whether an amount of time associated with the current surgical procedure step has passed, wherein the condition associated with the current surgical procedure step is satisfied based on the determination is taught in the Detailed Description in ¶ 0105-109 (teaching on only including data that meets a timeframe condition).
As per claim 8, Makrinich and Shelton discloses all of the limitations of claim 2. Makrinich also discloses the following:
the surgical computing system of claim 2, wherein the processor is configured to: determine that a portion of the subset of the annotated surgical procedure data is private data and that the surgical instrument is outside a patient data privacy protection boundary; and redact the portion of the subset of the annotated surgical procedure data based on the determination that the portion of the subset of the annotated surgical procedure data is private data, and the determination that the surgical instrument is outside the patient data privacy protection boundary is taught in the Detailed Description in ¶ 0089, ¶ 0094-96, ¶ 0320, ¶ 0335, and in the Figures at fig. 6 (teaching on the first subset of data including labeled surgical procedure data set in the database and classifying said data set into event categories and a second subset of data including patient identification data wherein the patient identification has been anonymized (treated as synonymous to redacted) prior to utilization from remote processors wherein the local database (treated as synonymous to inside v outside "a boundary") does not anonymize the data prior to storing to the database);
wherein the data package is generated in response to the redaction is taught in the Detailed Description in ¶ 0097, ¶ 0109, ¶ 0176-178, ¶ 0322, and in the Figures at fig. 9 (teaching on sending the notification for display on the surgical system's interface wherein the notification is based on the received surgical procedure data).
As per claim 9, Makrinich and Shelton discloses all of the limitations of claim 8. Makrinich also discloses the following:
the surgical computing system of claim 8, wherein the processor is configured to: store the subset of the annotated surgical procedure data in a local storage, wherein the subset of the annotated surgical procedure data is stored before portion of the subset of the annotated surgical procedure data is redacted is taught in the Detailed Description in ¶ 0089, ¶ 0094-96, ¶ 0320-321, and in the Figures at fig. 6 (teaching on the first subset of data including labeled surgical procedure data set in the database and classifying said data set into event categories and a second subset of data including patient identification data wherein the patient identification has been anonymized (treated as synonymous to redacted) prior to utilization from remote processors wherein the local database (treated as synonymous to inside v outside "a boundary") does not anonymize the data prior to storing to the database - Examiner notes this is the understood method of a global lookup hash value taught in the instant reference).
Claim 18 is rejected under the same rational as claims 8 and 9.
As per claim 10, Makrinich and Shelton discloses all of the limitations of claim 1. Makrinich fails to teach the following; Shelton, however, does disclose:
the surgical computing system of claim 1, wherein the surgical instrument is a surgical stapler, and wherein the data need is associated with adjusting control of the surgical stapler before transecting a fissure is taught in the Detailed Description in ¶ 0323 and ¶ 0363 (teaching on analyzing relevant anonymized historical surgical data packages to determine an adjustment to a stapler parameter when transecting a fissure).
One of ordinary skill in the art before the effective filing date would combine the relevant data query system for surgical planning of Makrinich with the intraoperation parameter adjustment of a surgical instrument of Shelton as “it would be desirable to monitor data associated with the surgical procedure to enable configuration and operation of instruments used during the procedure to improve surgical outcomes” (Shelton in the Detailed Description in ¶ 0302).
As per claim 12, Makrinich and Shelton discloses all of the limitations of claim 10. Makrinich fails to teach the following; Shelton, however, does disclose:
the surgical computing system of claim 10, wherein the subset of the annotated surgical procedure data indicates a tissue type, a tissue thickness, or a tissue density is taught in the Detailed Description in ¶ 0323 and ¶ 0363 (teaching on the adjustment to a stapler parameter when transecting a fissure being based on an identified tissue type).
One of ordinary skill in the art before the effective filing date would combine the relevant data query system for surgical planning of Makrinich with the intraoperation parameter adjustment of a surgical instrument of Shelton as “it would be desirable to monitor data associated with the surgical procedure to enable configuration and operation of instruments used during the procedure to improve surgical outcomes” (Shelton in the Detailed Description in ¶ 0302).
As per claim 13, Makrinich and Shelton discloses all of the limitations of claim 12. Makrinich fails to teach the following; Shelton, however, does disclose:
the surgical computing system of claim 12, wherein the operational parameter comprises at least one of a clamp load, a precompression time, or a firing speed, and is taught in the Detailed Description in ¶ 0323, ¶ 0341, and ¶ 0363 (teaching on the adjustment to a stapler parameter when transecting a fissure including a compression rate threshold parameter or a speed of firing);
wherein the data package causes the surgical stapler to pre-configure the operational parameter based on the subset of the annotated surgical procedure data prior to commencement of the subsequent surgical procedure step is taught in the Detailed Description in ¶ 0323 and ¶ 0393 (teaching on analyzing relevant anonymized historical surgical data packages to determine an adjustment to a stapler parameter when transecting a fissure prior to the fissure excision step).
One of ordinary skill in the art before the effective filing date would combine the relevant data query system for surgical planning of Makrinich with the intraoperation parameter adjustment of a surgical instrument of Shelton as “it would be desirable to monitor data associated with the surgical procedure to enable configuration and operation of instruments used during the procedure to improve surgical outcomes” (Shelton in the Detailed Description in ¶ 0302).
Claim 19 is rejected under the same rational.
Response to Arguments
Applicant's statements filed with respect to 35 USC § 101 have been fully considered. The subject matter eligibility rejection of the instant claims has been withdrawn as the recitation of “wherein the data package causes the surgical instrument to adjust the operational parameter associated with the surgical task based on the subset of the annotated surgical procedure data” is considered a meaningful limitation beyond generally linking the use of the judicial exception to a particular technological environment (see MPEP § 2106.05(e)).
Applicant’s arguments filed 28 April 2021 with respect to 35 USC § 102 have been considered and are persuasive regarding the newly added limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection under 35 USC § 103 is made in view of Shelton, as per the rejection above.
Applicant's arguments filed with respect to the Double Patenting rejection have been fully considered and are persuasive regarding the newly added limitations. Therefore, the rejection has been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JORDAN LYNN JACKSON whose telephone number is (571)272-5389. The examiner can normally be reached Monday-Friday 8:30AM-4:30PM ET.
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/JORDAN L JACKSON/
Primary Examiner, Art Unit 2857
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