DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
Acknowledgement is made to the amendment received 12/23/2025.
Acknowledgement is made to the amendment of claims 1, 3-4, and 15-17.
Claims 1-20 are pending. A complete action on the merits appears below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson (US 20100228264 A1) in view of Baker (US 20180214091 A1) and Reifman (US 8694085 B2).
Regarding claim 1, Robinson teaches a surgical system (¶Abstract) comprising:
a modular surgical instrument configured for use during a surgical procedure performed on a patient in an operating room of a hospital (¶ [0043]);
a combination generator configured to be communicably coupled to the modular surgical instrument, wherein the combination generator comprises a first control circuit and a first memory configured to store a control program executable by the first control circuit (¶[0043]- [0044], [0084]) to drive a delivery of a plurality of energy modalities (¶ [0082]) to the modular surgical instrument for treating a patient tissue (¶[0082], [0085]- [0086]), and wherein the first memory is configured to collect generator data (¶ [0047]- [0050]) comprising a characteristic of at least one of the energy modalities delivered to the modular surgical instrument during the surgical procedure (¶ [0085]- [0086]); and
an analytics subsystem communicably coupled to the combination generator, wherein the analytics subsystem comprises a memory and a control circuit (¶[0081]- [0082]) configured to:
receive the generator data collected by the first memory of the combination generator (¶[0083]); and
adaptively generate a control program based, at least in part, on the received generator data, to control a way the control circuit of the combination generator drives the delivery the at least one of the energy modalities to the modular surgical instrument during the surgical procedure (¶[0085]- [0086]).
However, Robinson fails to teach the sub-system as being cloud-based.
Baker teaches a patient monitoring system usable in surgical settings, including sensors, a patient support assembly, a cloud-based gateway device and a control module (¶Abstract, [0034]).
Baker further teaches the cloud-based gateway as receiving and analyzing patient-specific data from the patient support assembly and an EMR (¶[0041], [0043]- [0044]) and determining a patient status so as to use received data to update the patient-related actions so as to provide improved patient outcomes (¶[0002]- [0003]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the cloud-based gateway for receiving information relevant to the patient and updating the patient treatment based on this, as is taught by Baker, into the system of Robinson, to produce the predictable result of substituting one known controlling system for another to treat a patient.
Robinson further fails to teach the system as adaptively updating the control program based on data and altering the way the circuit controls the system to create a second memory and control circuit.
Reifman teaches a system having a storage and communications module for interacting with a medical device and an analysis controller (¶Abstract).
Reifman further teaches the controller utilizing algorithms which interact with the received information so as to be updated, modified or changed as necessary allowing the new/modified algorithm to be available for the subsequent use (Col. 5, Lines 15-40).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of an algorithm which updates, modified, or changes as is taught by Reifman into the control program of Robinson to allow for the predictable result of an algorithm which is modified or new to be used in subsequent uses as necessary, as is taught by Reifman.
Regarding claim 2, Robinson teaches the surgical system of claim 1, wherein the plurality energy modalities comprises at least one of: a monopolar radio-frequency energy, a bipolar radio- frequency energy an advanced bipolar radio-frequency energy an ultrasonic radio-frequency energy, or combinations thereof (¶ [0084]- [0085]).
Regarding claim 3, Robinson teaches the surgical system of claim 2, wherein the characteristic of the at least one of the energy modalities delivered to the modular surgical instrument during the surgical procedure comprises a type of the energy modality delivered to the modular surgical instrument during the surgical procedure, a type of radio-frequency energy delivered to the modular surgical instrument during the surgical procedure, a frequency level of the at least one of the energy modalities delivered to the modular surgical instrument during the surgical procedure, a power output corresponding to the delivery of the at least one of the energy modalities delivered during the surgical procedure, and a duration of delivery of the at least one of the energy modalities delivered during the surgical procedure (¶[0084]- [0086]).
Regarding claim 15, Robinson teaches a surgical system (¶Abstract) comprising:
a combination generator configured to be communicably coupled to a modular surgical instrument configured for use during a surgical procedure performed on a patient in an operating room of a hospital (¶[0082]), wherein the combination generator comprises a first control circuit and a first memory configured to store a control program executable by the control circuit to drive a delivery of a plurality of energy modalities to the modular surgical instrument for treating a patient tissue, and wherein the first memory is configured to collect generator data (¶[0083]- [0086]) comprising a characteristic of at least one of the energy modalities delivered to the modular surgical instrument during the surgical procedure (¶[0085]- [0086]); and
an analytics subsystem communicably coupled to the combination generator, wherein the analytics subsystem comprises a memory and a control circuit (¶[0081]- [0082]) configured to:
receive the generator data collected by the data collection module first memory of the combination generator (¶[0083]); and
adaptively generate a control program based, at least in part, on the received generator data, to control a way the control circuit of the combination generator delivers the at least one of the energy modalities to the modular surgical instrument during the surgical procedure (¶[0085]- [0086]).
However, Robinson fails to specifically teach the subsystem as being cloud-based.
Baker teaches a patient monitoring system usable in surgical settings, including sensors, a patient support assembly, a cloud-based gateway device and a control module (¶Abstract, [0034]).
Baker further teaches the cloud-based gateway as receiving and analyzing patient-specific data from the patient support assembly and an EMR (¶[0041], [0043]- [0044]) and determining a patient status so as to use received data to update the patient-related actions so as to provide improved patient outcomes (¶[0002]- [0003]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the cloud-based gateway for receiving information relevant to the patient and updating the patient treatment based on this, as is taught by Baker, into the system of Robinson, to produce the predictable result of substituting one known controlling system for another to treat a patient.
Reifman teaches a system having a storage and communications module for interacting with a medical device and an analysis controller (¶Abstract).
Reifman further teaches the controller utilizing algorithms which interact with the received information so as to be updated, modified or changed as necessary allowing the new/modified algorithm to be available for the subsequent use (Col. 5, Lines 15-40).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of an algorithm which updates, modified, or changes as is taught by Reifman into the control program of Robinson to allow for the predictable result of an algorithm which is modified or new to be used in subsequent uses as necessary, as is taught by Reifman.
Regarding claim 16, Robinson teaches the surgical system of claim 15, wherein the plurality energy modalities comprises at least one of: a monopolar radio-frequency energy, a bipolar radio- frequency energy, an advanced bipolar radio-frequency energy, an ultrasonic radio-frequency energy to the modular surgical instrument, or combinations thereof and wherein the characteristic of the at least one of the energy modalities delivered to the modular surgical instrument during the surgical procedure comprises a type of the energy modality delivered to the modular surgical instrument during the surgical procedure, a type of radio-frequency energy delivered to the modular surgical instrument during the surgical procedure, a frequency level of the at least one of the energy modalities delivered to the modular surgical instrument during the surgical procedure, a power output corresponding to the delivery of the at least one of the energy modalities delivered during the surgical procedure, and a duration of delivery of the at least one of the energy modalities delivered during the surgical procedure (¶[0084]- [0086]).
Claims 4-12 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson (US 20100228264 A1) in view of Baker (US 20180214091 A1) and Reifman (US 8694085 B2) further in view of Holman (US 20150269384 A1).
Regarding claim 4, Baker teaches the surgical system of claim 3, further comprising an electronic medical record (EMR) database communicably coupled to the combination generator and located within the hospital, wherein, the cloud-based analytics subsystem is communicably coupled to the EMR database, and wherein the control circuit of the cloud-based analytics subsystem (¶[0034], [0041]) is further configured to:
receive data structures stored on the EMR database (¶[0041], [0043]- [0044]); and
generate the control program update based, at least in part, on the data structures received from the EMR database (¶[0041], [0043]- [0044]).
However, Robinson/Baker fails to teach the EMR database being configured to store data structures within a data barrier of the hospital.
Holman teaches a system for providing privacy during data processing from one system to another, such as through cloud storage, to desirable devices such as medical devices (¶Abstract, [0131], [0236]).
Holman further teaches providing a barrier, such as a data access barrier, within the system so as to exclude module which do not have data from accessing specific information or data (¶[0277]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the barrier to provide for data protection within medical systems using cloud storage, as is taught by Holman, into the modified medical system using cloud-based systems usable with private data, such as medical record, of Robinson/Baker, to provide protection to the data when access has not been provided, as is taught by Holman.
Regarding claim 5, in accordance with the above rejection of claim 4, Holman further teaches the surgical system of claim 4, wherein the cloud-based analytics subsystem is external to the data barrier of the hospital, and wherein the EMR database is further configured to redact the data structures prior to receipt by the cloud-based analytics subsystem (¶[0277]).
Regarding claim 6, in accordance with the above rejection of claim 4, Holman further teaches the surgical system of claim 5, wherein the data collection module stored in the memory of the combination generator is configured to transmit the generator data to the EMR database, and wherein the EMR database is further configured to redact the generator data prior to receipt by the cloud-based analytics subsystem (¶[0277]).
Regarding claim 7, Robinson further teaches the surgical system of claim 4, further comprising a surgeon control subsystem, wherein the surgeon control subsystem comprises:
an image sensor communicably coupled the combination generator, wherein the image sensor is configured to generate image data associated with the surgical procedure (¶[0042], [0316]); and
a display communicably coupled to the combination generator, wherein the control circuit of the combination generator is further configured to cause the display to present a personal interface configured for use during the surgical procedure, and wherein the personal interface comprises image data generated by the image sensor (¶[0045]).
Regarding claim 8, Robinson further teaches the surgical system of claim 7, wherein the control circuit of the combination generator is configured to generate at least one of: an anatomic measurement, a critical structure identity, and a critical structure location, or combinations thereof based, at least in part, on the image data generated by the image sensor, and wherein the personal interface comprises at least one of: the anatomic measurement, the critical structure identity, and the critical structure location, or combinations thereof (¶[0176], [0267], [0304] teach the interface and controller of the system as providing information relevant to the tools which are critical procedure structures, such as states and location).
Regarding claim 9, Robinson further teaches the surgical system of claim 8, wherein the personal interface further comprises preoperative images (¶[0211], [0222]).
Regarding claim 10, Robinson further teaches the surgical system of claim 8, wherein the display is a touchscreen display of a tablet positioned within a sterile field of the operating room (¶[0138]).
Regarding claim 11, Robinson further teaches the surgical system of claim 10, wherein the touchscreen display is configured such that a surgeon within the sterile field can manipulate the personal interface via a plurality of gestures comprising at least one of: a drag and drop, a scroll, a zoom, a rotate, a tap, a double tap, a flick, a drag, a swipe, a pinch open, a pinch close, a touch and hold, and a two-finger scroll, or combinations thereof (¶[0138], [0149]).
Regarding claim 12, Robinson further teaches the surgical system of claim 11, wherein the surgical instrument is at least one of: a handheld surgical stapler, an ultrasonic surgical instrument, a radio-frequency electrosurgical instrument, and a multifunction surgical instrument (¶[0050]).
Regarding claim 17, Baker further teaches the surgical system of claim 16, further comprising an electronic medical record (EMR) database communicably coupled to the combination generator and located within the hospital, wherein the cloud-based analytics subsystem is communicably coupled to the EMR database, and wherein the control circuit of the cloud-based analytics subsystem (¶[0034], [0041]) is further configured to:
receive data structures stored on the EMR database (¶[0041], [0043]- [0044]); and
generate the control program update based, at least in part, on the data structures received from the EMR database (¶[0041], [0043]- [0044]).
Holman teaches a system for providing privacy during data processing from one system to another, such as through cloud storage, to desirable devices such as medical devices (¶Abstract, [0131], [0236]).
Holman further teaches providing a barrier, such as a data access barrier, within the system so as to exclude module which do not have data from accessing specific information or data (¶[0277]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the barrier to provide for data protection within medical systems using cloud storage, as is taught by Holman, into the modified medical system using cloud-based systems usable with private data, such as medical record, of Robinson as modified, to provide protection to the data when access has not been provided, as is taught by Holman.
Regarding claim 18, in accordance with the above rejection of claim 17, Holman further teaches the surgical system of claim 17, wherein the cloud-based analytics subsystem is external to the data barrier of the hospital, and wherein the EMR database is further configured to redact the data structures prior to receipt by the cloud-based analytics subsystem (¶[0277]).
Regarding claim 19, Robinson teaches the surgical system of claim 18, further comprising a surgeon control subsystem, wherein the surgeon control subsystem comprises:
an image sensor communicably coupled the combination generator, wherein the image sensor is configured to generate image data associated with the surgical procedure (¶[0042], [0316]); and
a display communicably coupled to the combination generator, wherein the control circuit of the combination generator is further configured to cause the display to present a personal interface configured for use during the surgical procedure, and wherein the personal interface comprises image data generated by the image sensor (¶[0045]).
Regarding claim 20, Robinson teaches the surgical system of claim 19, wherein the display is a touchscreen display of a tablet positioned within a sterile field of the operating room (¶[0138]).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson (US 20100228264 A1) in view of Baker (US 20180214091 A1) and Reifman (US 8694085 B2) further in view of Weiner (US 20170090507 A1).
Regarding claim 13, Robinson as modified teaches the surgical system of claim 12,
Robinson further teaches the system as comprising a plurality of tools having end effectors for treating tissue in a variety of manners, such as providing ultrasonic energy or radio-frequency energy (¶[0002]), and the tools being capable of having a plurality of end effectors (¶[0154]).
However Robinson fails to teach the system wherein the multifunction surgical instrument comprises an ultrasonic mode and a radio-frequency energy mode.
Weiner teaches a generator configured to provide surgical instruments with effects for treating various tissue effects such as providing multiple treatment modalities simultaneously to a single or multiple surgical instruments (¶[0011]).
Weiner further teaches providing both RF and ultrasonic energy modalities either simultaneously or sequentially (¶[0049]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teaching of utilizing a single treatment tool to provide both RF and ultrasonic energy to tissue at the same time, as is taught by Weiner, into the modified surgical system to provide the predictable result of providing a treatment which is customized to the specific surgical instrument is tissue effects provided, as are taught by Weiner.
Regarding claim 14, Weiner further teaches the surgical system of claim 13, wherein the ultrasonic mode and the radio-frequency energy modes are configured to be delivered simultaneously (¶[0049]).
Response to Arguments
Applicant’s arguments dated 12/23/2025 that Robinson does not teach the claim limitation of “a combination generator [comprising], a first control circuit and a first memory […] wherein the first memory is configured to collect generator data comprising a characteristic of at least one of the energy modalities delivered to the modular surgical instrument during the surgical procedure” are currently unpersuasive.
Robinson teaches the combination generator limitation in the control cart 150B, which is a generator device comprised of a plurality of elements, such as one or more electrosurgical generators 102A’…102N’ and a computer 151B, the computer being taught as including a microprocessor to execute instructions to control the surgical system, including the electrosurgical generators and a memory which includes tool-type data, which is taught as including control information and signals on how the tool is to be controlled, including data relevant to energy activation and energy sub-features which include the type of energy the tool receives from the generators. This computer provides, for example, compatibility which determine if the system is compatible with the tool-type. In this compatibility of the tool-type data, which is stored in the computer of the control cart, of the tool and of the energy which is provided specifically from the electrosurgical generators, the limitation of the combination generator collecting data of a characteristic of at least one of the energy modalities is taught.
Further, as a characteristic is defined as being a distinguishing trait, quality, or property, the information, such as the type of energy which is delivered to the surgical instrument during a procedure, for example, tool-type data which discusses the type of energy the tool may receive, and its compatibility with the with the system, including the energy generators which provide energy to said tool as is taught by Robinson teaches this limitation as broadly as is currently claimed, absent any additional limitations, such as those surrounding the structure of the device, the manner specifically in which that data relevant to the characteristic is received from and/or delivered to the generator.
Additionally, it should be noted that in dependent claim 3 the characteristic of the at least one of the energy modalities includes not just the type of energy delivered but also the duration of the delivery. Robinson additionally teaches that the tool-type data, which can be stored either in an integrated circuit, which is stored within the tool, or in the memory of the computer, can include duration of the use of the tool, such as by clock time or by procedure. This also provides a characteristic of the energy delivered during the surgical procedure, as broadly as is currently claimed.
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 extension fee 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 date of this final action.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794