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 .
Formal Matters
Applicant’s Response and Amendments filed 4/29/2026 are acknowledged and entered. Claims 2, 4, 5, and 18 are cancelled. Claims 1, 3, and 13 are currently amended. Claims 1, 3, and 6-17 are pending and under examination.
Objections/Rejections Withdrawn
The objection to the Specification is withdrawn in light of Applicant’s amendments
Response to Arguments
Regarding the rejection under 35 USC 103 over Scoggins, Applicant argues that the Office Action indicates that the ultrasonic medical device 10 of Scoggins is equivalent to the cordless surgical instrument of claim 1 and the control system 108 of the medical device 100 of Scoggins is equivalent to the communication hub of claim 1 (Remarks p. 10 of 14). Applicant argues that while control system 108 may be included as part of the ultrasonic medical device 10 or within the medical device 100, there is no teaching or suggestion that the control system 108 of the medical device 100 would wireless communicate with the medical device 10 or another instance of medical device 100 (Remarks p. 10 of 14). Applicant argues that the “boilerplate language of Scoggins in ¶¶252-253” are overly broad and could be performed by any combination and no not teach or reasonably suggest the amended claims. Applicant argues that the existence of sensors in Scoggins is not reasonably equivalent to a cordless surgical instrument configured to obtain information regarding preparation of the cordless surgical instrument for use (Remarks, p. 10 of 14). Applicant argues that the general statement of Scoggins at ¶¶252-253 could be performed by any combination and are overly broad and do not reasonably teach or suggest claims as amended (Remarks, p. 10 of 14 to p.11 of 14). Applicant argues that the same arguments are applicable over amended claim 13. Applicant’s arguments have been fully considered, but are not persuasive in light of Applicant’s claim amendments and the modified rejections presented below, necessitated by amendment.
Additionally, the claims are system claims drawn to apparatus or devices. There are structural requirements in the amended claims. However, there are also intended use aspects of the claims that accompany functional claim language. The “configured to” functional language is analyzed in context. As long as the devices contain the requisite structure(s) required to achieve the recited function(s), the device may be said to be configured to perform the function. MPEP 2111.04. Applicant is also reminded that the recitation of an element that is “capable of” performing a function is not a positive limitation, but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. See In re Hutchison, 69 USPQ 138, 33 CCPA 879 (1946).
Modified Claim Rejections – Necessitated by Amendment
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 6-17 are rejected under 35 U.S.C. 103 as being unpatentable over Scoggins et al., US 20190008543 (10 January 2019) in view of Shelton et al., US 20190125458 (2 May 2019).
Regarding currently amended independent claim 1, Scoggins teaches a surgical system (FIGs 1, 16), comprising:
a cordless (battery powered, ¶75) surgical instrument (medical device 100 (FIG 16) may be similar to or representative of ultrasonic medical device 10 (FIG 1); ¶150) comprising a first processor (“processor located in the medical device” ¶157), a first memory (“instructions may be stored in a nonvolatile memory component accessible to the computing processor”, ¶157), and first input/output interface configured to perform wireless communication (¶253), wherein the cordless surgical instrument is configured to obtain information (instructions, ¶157) regarding preparation of the cordless surgical instrument for use (¶157), the information including information regarding assembly of the cordless surgical instrument (“the instructions may embody one or more methods to test the medical device for proper reassembly and component function. Such instructions may further notify the user of the outcome of such tests, including recommendations to address detected faults or anomalies in reassembly; medical device may include multiple computing processors any or all of which may execute one or more of the instructions that may encode one or more methods to test the medical device for proper reassembly and component functioning. These methods may be incorporated in one or more pre-surgical processes to test the functional integrity of the medical device prior to medical use;”, ¶157);
wherein the output displays (audio feedback via speakers 114, visual feedback via one or more displays 116, ¶151), via the user interface (instruction to a user, ¶158), of a plurality of steps for assembling the cordless surgical instrument for use (method steps including instructions to a user, ¶158), and wherein the display switches between different steps of the plurality of steps (¶151).
Scoggins does not expressly teach a connected device comprising a second processor, a second input/output interface, and a user interface; and a communication hub comprising a third processor and a third input/output interface, the communication hub configured to wirelessly connect to the cordless surgical instrument to receive the information therefrom, the communication hub configured to instruct, based at least on the information, the connected device to provide an output relating to the preparation of the cordless surgical instrument for use.
Additionally, although Scoggins teaches wherein the display switches between different steps of the plurality of steps (¶151), Scoggins does not expressly teach this display switching based on additional information wirelessly communicated from the cordless surgical instrument to the communication hub.
Shelton teaches computer-implemented interactive surgical system 200 (FIG 9) comprising: a wireless (¶588) device/instrument 235, device/instrument display 237, generator module 240, modular control tower 236, communication module 230, and surgical system 202 (FIG 10), which comprises at least one surgical hub 205 in communication with cloud 204 that may include remote server 213, communication hub 203 coupled to computer system 210 (¶595). FIG 10 shows modular communication hub 203 coupled to computer system 210 comprising a processor 244, memory 249, non-volatile memory 250, and input/output interface 251 via a system bus (¶598) and configured to wirelessly connect (¶588) to the surgical instrument 235 to receive the information therefrom. Shelton teaches that the communication hub is configured to instruct (FIG 8, ¶¶583, 587), based at least on the information, the connected device to provide an output relating to the preparation of a surgical instrument for use (¶2278). Shelton teaches display switching based on additional information wirelessly communicated from the surgical instrument to the communication hub (FIGs 190, 193, 194, computer-implemented interactive surgical system is configured to adaptively generate control program update for modular devices; ¶245, 248, 249). Battery powered surgical devices are taught at ¶611.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Scoggins and Shelton, given that the prior art included each element claimed, although not necessarily in a single reference. Scoggins and Shelton teach in the same field of endeavor, computerized surgical systems and devices comprising controllers, processors, and at least one memory.
Although, Scoggins discloses the claimed base cordless (battery operated) surgical device comprising a first processor, a first memory, and a first input/output interface, Scoggins does not disclose a connected device comprising a second processor, a second input/output interface, and a user interface; and a communication hub comprising a third processor and a third input/output interface.
Shelton specifically addresses a computer-implemented interactive surgical system 200 (FIG 9) comprising: a wireless (¶588) device/instrument 235, device/instrument display 237, , modular control tower 236, communication module 230, and surgical system 202 (FIG 10), which comprises at least one surgical hub 205 in communication with cloud 204 that may include remote server 213, communication hub 203 coupled to computer system 210 (¶595). FIG 10 shows modular communication hub 203 coupled to computer system 210 comprising a processor 244, memory 249, non-volatile memory 250, and input/output interface 251 via a system bus (¶598) and configured to wirelessly connect (¶588) to the surgical instrument 235 to receive the information therefrom. Shelton teaches that the communication hub is configured to instruct (FIG 8, ¶¶583, 587), based at least on the information, the connected device to provide an output relating to the preparation of a surgical instrument for use (¶2278). Shelton teaches display switching based on additional information wirelessly communicated from the surgical instrument to the communication hub (FIGs 190, 193, 194, computer-implemented interactive surgical system is configured to adaptively generate control program update for modular devices; ¶245, 248, 249). Battery powered surgical devices are taught at ¶611.
Because Scoggins’ base cordless surgical device is a modular component of a larger surgical system taught by Shelton, a person of ordinary skill in the art, seeking to implement individual surgical devices with wireless features into a larger computer-implemented interactive surgical system comprising wireless access to information via servers or on the Internet/cloud using Scoggin’s device would reasonably consult Shelton’s computer-implemented interactive surgical system solution. Shelton’s modular component system can be incorporated alongside Scoggins’ computerized, battery-powered surgical instrument and modularly integrated into the communication hub-based system of Shelton using known assembly methods without redesigning Scoggins’ surgical instrument. A person of ordinary skill in the art attempting to render Scoggins’ surgical device compatible for computer-implemented interactive surgical system integration would look for established connector/articulation designs to avoid creating a novel interface.
Because the references address the same engineering problem (connecting computer-based surgical instruments to a computer-implemented interactive surgical system) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a wireless-capable device to a larger computer-implemented interactive surgical system), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Additionally, a person of ordinary skill in the art attempting to integrate Scoggins’ surgical device into a larger computer-implemented interactive surgical system would just need to connect the device in order to seek and receive the desired information from a variety of sources, whose selection are a matter of design choice as diverse as the instrumentation and various manufacturers and the information/data they supply. This information would be a device or user defined results-effective variable, which is optimizable based on the information desired by the user and the information available from the device manufacturer.
Regarding currently amended claim 3, Scoggins modified by Shelton teaches the surgical system according to claim 1, as set forth above, for the reasons set forth above.
Scoggins teaches wherein the information regarding assembly of the cordless surgical instrument (FIGs 1, 16; 10/100) includes information indicating that first and second components of the cordless surgical instrument are engaged with one another (¶¶156-159).
Regarding claim 6, Scoggins modified by Shelton teaches the surgical system according to claim 1, as set forth above, for the reasons set forth above.
Scoggins teaches wherein the information regarding preparation of the cordless surgical instrument (FIGs 1, 16; 10/100) for use includes identifying information for a plurality of components of the cordless surgical instrument (¶¶156-159).
Regarding claim 7, Scoggins modified by Shelton teaches the surgical system according to claim 6, as set forth above, for the reasons set forth above.
Scoggins teaches wherein the output includes display of an indication of whether the plurality of components of the cordless surgical instrument is approved for use (¶¶156-159).
Regarding claim 8, Scoggins modified by Shelton teaches the surgical system according to claim 1, as set forth above, for the reasons set forth above.
Scoggins teaches wherein the information regarding preparation of the cordless surgical instrument (FIGs 1, 16; 10/100) for use includes information regarding an instrument test of the cordless surgical instrument (¶¶156-159).
Regarding claim 9, Scoggins modified by Shelton teaches the surgical system according to claim 8, as set forth above, for the reasons set forth above.
Scoggins teaches wherein the output includes display of an indication of whether the cordless surgical instrument passed or failed the instrument test (¶¶156-159).
Regarding claim 10, Scoggins modified by Shelton teaches the surgical system according to claim 9, as set forth above, for the reasons set forth above.
Scoggins teaches wherein, in a case where the cordless surgical instrument (FIGs 1, 16; 10/100) failed the instrument test (¶156), the output further includes at least one of an indication of a cause of the failed instrument test or a troubleshooting recommendation (¶157).
Regarding claim 11, Scoggins modified by Shelton teaches the surgical system according to claim 1, as set forth above, for the reasons set forth above.
Scoggins teaches wherein the cordless surgical instrument (FIGs 1, 16; 10/100) includes a battery assembly (¶75) and a generator (20/102), the generator configured to drive the cordless surgical instrument, the generator powered by the battery assembly (¶¶75, 150, 156).
Regarding claim 12, Scoggins modified by Shelton teaches the surgical system according to claim 11, as set forth above, for the reasons set forth above.
Scoggins teaches wherein the cordless surgical instrument (FIGs 1, 16; 10/100) further includes an ultrasonic transducer (104) and an ultrasonic blade (66; ¶156) coupled to the ultrasonic transducer (104), the generator (20/102) configured to drive the ultrasonic transducer to produce mechanical vibration motion at the ultrasonic blade (FIG 16; ¶150).
Regarding currently amended independent claim 13, Scoggins teaches a surgical system (FIGs 1, 16), comprising:
a cordless (battery powered, ¶75) surgical instrument (medical device 100 (FIG 16) may be similar to or representative of ultrasonic medical device 10 (FIG 1); ¶150) comprising a first processor (“processor located in the medical device” ¶157), a first memory (“instructions may be stored in a nonvolatile memory component accessible to the computing processor”, ¶157), and first input/output interface configured to perform wireless communication (¶253), wherein the cordless surgical instrument is configured to obtain information (instructions, ¶157) regarding preparation of the cordless surgical instrument for use (¶157), the information including information regarding assembly of the cordless surgical instrument (“the instructions may embody one or more methods to test the medical device for proper reassembly and component function. Such instructions may further notify the user of the outcome of such tests, including recommendations to address detected faults or anomalies in reassembly; medical device may include multiple computing processors any or all of which may execute one or more of the instructions that may encode one or more methods to test the medical device for proper reassembly and component functioning. These methods may be incorporated in one or more pre-surgical processes to test the functional integrity of the medical device prior to medical use;”, ¶157);
wherein the output displays (audio feedback via speakers 114, visual feedback via one or more displays 116, ¶151), via the user interface (instruction to a user, ¶158), of a plurality of steps for assembling the cordless surgical instrument for use (method steps including instructions to a user, ¶158), and wherein the output includes display, via the user interface, of two or more steps to remove and replace the at least one replaceable component (¶151).
Scoggins does not expressly teach a connected device comprising a second processor, a second input/output interface, and a user interface; and a communication hub comprising a third processor and a third input/output interface, the communication hub configured to wirelessly connect to the cordless surgical instrument to receive the information therefrom, the communication hub configured to instruct, based at least on the information, the connected device to provide an output relating to the preparation of the cordless surgical instrument for use.
Shelton teaches computer-implemented interactive surgical system 200 (FIG 9) comprising: a wireless (¶588) device/instrument 235, device/instrument display 237, generator module 240, modular control tower 236, communication module 230, and surgical system 202 (FIG 10), which comprises at least one surgical hub 205 in communication with cloud 204 that may include remote server 213, communication hub 203 coupled to computer system 210 (¶595). FIG 10 shows modular communication hub 203 coupled to computer system 210 comprising a processor 244, memory 249, non-volatile memory 250, and input/output interface 251 via a system bus (¶598) and configured to wirelessly connect (¶588) to the surgical instrument 235 to receive the information therefrom. Shelton teaches that the communication hub is configured to instruct (FIG 8, ¶¶583, 587), based at least on the information, the connected device to provide an output relating to the preparation of a surgical instrument for use (¶2278). Battery powered surgical devices are taught at ¶611.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Scoggins and Shelton, given that the prior art included each element claimed, although not necessarily in a single reference. Scoggins and Shelton teach in the same field of endeavor, computerized surgical systems and devices comprising controllers, processors, and at least one memory.
Although, Scoggins discloses the claimed base cordless (battery operated) surgical device comprising a first processor, a first memory, and a first input/output interface, Scoggins does not disclose a connected device comprising a second processor, a second input/output interface, and a user interface; and a communication hub comprising a third processor and a third input/output interface.
Shelton specifically addresses a computer-implemented interactive surgical system 200 (FIG 9) comprising: a wireless (¶588) device/instrument 235, device/instrument display 237, , modular control tower 236, communication module 230, and surgical system 202 (FIG 10), which comprises at least one surgical hub 205 in communication with cloud 204 that may include remote server 213, communication hub 203 coupled to computer system 210 (¶595). FIG 10 shows modular communication hub 203 coupled to computer system 210 comprising a processor 244, memory 249, non-volatile memory 250, and input/output interface 251 via a system bus (¶598) and configured to wirelessly connect (¶588) to the surgical instrument 235 to receive the information therefrom. Shelton teaches that the communication hub is configured to instruct (FIG 8, ¶¶583, 587), based at least on the information, the connected device to provide an output relating to the preparation of a surgical instrument for use (¶2278). Battery powered surgical devices are taught at ¶611.
Because Scoggins’ base cordless surgical device is a modular component of a larger surgical system taught by Shelton, a person of ordinary skill in the art, seeking to implement individual surgical devices with wireless features into a larger computer-implemented interactive surgical system comprising wireless access to information via servers or on the Internet/cloud using Scoggin’s device would reasonably consult Shelton’s computer-implemented interactive surgical system solution. Shelton’s modular component system can be incorporated alongside Scoggins’ computerized, battery-powered surgical instrument and modularly integrated into the communication hub-based system of Shelton using known assembly methods without redesigning Scoggins’ surgical instrument. A person of ordinary skill in the art attempting to render Scoggins’ surgical device compatible for computer-implemented interactive surgical system integration would look for established connector/articulation designs to avoid creating a novel interface.
Because the references address the same engineering problem (connecting computer-based surgical instruments to a computer-implemented interactive surgical system) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a wireless-capable device to a larger computer-implemented interactive surgical system), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Additionally, a person of ordinary skill in the art attempting to integrate Scoggins’ surgical device into a larger computer-implemented interactive surgical system would just need to connect the device in order to seek and receive the desired information from a variety of sources, whose selection are a matter of design choice as diverse as the instrumentation and various manufacturers and the information/data they supply. This information would be a device or user defined results-effective variable, which is optimizable based on the information desired by the user and the information available from the device manufacturer.
Regarding claim 14, Scoggins modified by Shelton teaches the surgical system according to claim 13, as set forth above, for the reasons set forth above.
Scoggins teaches wherein the at least one replaceable component is a battery assembly (¶¶75, 156, 159).
Regarding claim 15, Scoggins modified by Shelton teaches the surgical system according to claim 14, as set forth above, for the reasons set forth above.
Scoggins teaches wherein the cordless surgical instrument (FIGs 1, 16; 10/100) includes a generator (20/102) configured to drive the cordless surgical instrument, the generator powered by the battery assembly (¶75).
Regarding claim 16, Scoggins modified by Shelton teaches the surgical system according to claim 14, as set forth above, for the reasons set forth above.
Scoggins teaches wherein the information includes a state of charge of the battery assembly (¶159), and wherein the communication hub (108) is configured to instruct (¶¶156-159), based at least on the state of charge of the battery assembly being below a threshold value, the connected device to provide the output (¶159).
Regarding claim 17, Scoggins modified by Shelton teaches the surgical system according to claim 14, as set forth above, for the reasons set forth above.
Scoggins teaches wherein the information includes an indication that a state of charge of the battery assembly is below a threshold value (¶¶158-159).
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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