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 .
Benefit
The application is a National Stage filing of PCT/IB2023/055121 (18 May 2023) that claims benefit to US Provisional 63/343231 (18 May 2022).
Formal Matters
Claims 1-18 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 23 October 2024 has been considered by the examiner. A signed copy is attached.
Specification - Objection
The disclosure is objected to because of the following informalities: FIG 1 shows devices labeled 10, 30, 40, 50, 60, and 70. However, the specification references “connected devices 40-70” in ¶¶22-25 and 42-45. This range of “connected devices” in the specification includes element numbers that are not otherwise present in FIG 1. For example, the range includes 41, 42, 43, 44, etc, when the recitation of a range of connected devices 40-70. Accordingly, it is suggested that the specification be amended to recite what is recited in the figures without inclusion of short-hand notation (e.g. connected devices 40, 50, 60, 70). Any amendment must not introduce new matter (35 USC 132(a)) and should maintain consistent reference numerals throughout, per MPEP 608.02 and 37 CFR 1.121(b).
Appropriate correction is required.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Scoggins et al., US 20190008543 (10 January 2019).
Regarding claim 1, Scoggins teaches a surgical system (FIGs 1, 16), comprising:
a cordless surgical instrument (10; ¶75 battery powered) configured to obtain information (data signals, electrical signals, ¶152) regarding preparation of the cordless surgical instrument for use (¶¶97).
Scoggins teaches battery-powered device 10 (¶75) and separately a control system 108 that wirelessly communicates (¶¶252-253) with surgical devices to guide preparation (¶¶150-159). Scoggins teaches the communications hub (108) in conjunction with ultrasonic medical device 100 (FIG 16; ¶150). Scoggins also teaches that medical device 100 may be similar to or representative of ultrasonic medical device 10 (¶150).
Scoggins teaches communication hub (108) is configured to wirelessly connect (wireless communication link, transmitter, receiver, transmission logic, reception logic, ¶¶252-253) to the cordless surgical instrument (10/100, ¶150) to receive the information (data signals, electrical signals, ¶152) therefrom (¶152),
the communication hub (108) configured to instruct (feedback, ¶151), based at least on the information (data signals, electrical signals, ¶152) a connected device (speakers 114, visual displays 116, ¶151) to provide an output relating to the preparation of the cordless surgical instrument for use (¶¶157-158).
A person of ordinary skill in the art, seeking to provide a centralized, wireless communications hub for cordless/battery-powered surgical instruments would reasonably consult the multiple embodiments of Scoggins’ as system-based solutions. Scoggins’ battery powered instrument can be incorporated alongside the embodiment of ultrasound surgical instruments utilizing a communications hub without redesigning Scoggin’s core devices (¶71).Because the different embodiments of Scoggins are interrelated, overlap, and address the same engineering problem (reusable ultrasonic medical devices comprising control modules capable of receiving and utilizing functional data about the device) and Scoggins expressly teaches that medical device 100 may be similar to or representative of ultrasonic medical device 10 (¶150), the proposed modifications relevant to embodiment 100 are mechanically compatible and implemented by routine engineering practices (adding or substituting a battery-powered motor or a control system linked to a wireless communication hub). Accordingly, 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 based on the express teachings in Scoggins. The level of ordinary skill in the art is a person having a BS in EE/ME/BME and 2-5 years in surgical instrument systems and HMI/telemetry.
Regarding claim 2, Scoggins teaches the surgical system according to claim 1, as set forth above, wherein the information regarding preparation of the cordless surgical instrument (FIGs 1, 16; 10/100) for use includes information regarding assembly of the cordless surgical instrument (¶¶156-159).
Regarding claim 3, Scoggins teaches the surgical system according to claim 2, as set forth above, 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 4, Scoggins teaches the surgical instrument according to claim 2, as set forth above, wherein the output includes display of at least one step for assembling the cordless surgical instrument for use (¶158).
Regarding claim 5, Scoggins teaches the surgical instrument according to claim 4, as set forth above, wherein the output includes display of a plurality of steps for assembling the cordless surgical instrument (FIGs 1, 16; 10/100) for use, and wherein the display switches between different steps of the plurality of steps based on additional information wirelessly communicated (¶252-253) from the cordless surgical instrument (FIGs 1, 16; 10/100) to the communication hub (¶158).
Regarding claim 6, Scoggins teaches the surgical system according to claim 1, as set forth above, 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 teaches the surgical system according to claim 6, as set forth above 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 teaches the surgical system according to claim 1, as set forth above, 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 teaches the surgical system according to claim 8, as set forth above, 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 teaches the surgical system according to claim 9, as set forth above, 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 teaches the surgical system according to claim 1, as set forth above, 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 teaches the surgical system according to claim 11, as set forth above, 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 independent claim 13, Scoggins teaches a surgical system (FIGs 1, 16), comprising:
Scoggins teaches battery-powered surgical device 10 (¶75) and separately ultrasonic medical device 100 (FIG 16; ¶150) configured to obtain information regarding at least one replaceable component (¶155) of the cordless surgical instrument (¶¶70, 150).
Scoggins also teaches that medical device 100 may be similar to or representative of ultrasonic medical device 10 (¶150).
Scoggins teaches a communication hub (control system 108) in conjunction with ultrasonic medical device 100 (FIG 16; ¶150) configured to wirelessly connect (wireless communication link, transmitter, receiver, transmission logic, reception logic, ¶¶252-253) to the cordless surgical instrument to receive the information (data signals, electrical signals, ¶152) therefrom (¶152),
the communication hub (108) configured to instruct (feedback, ¶151), based at least on the information (data signals, electrical signals, ¶152), a connected device to provide an output (data signals, electronic signals, ¶152) relating to replacement of the at least one replaceable component (¶155) of the cordless surgical instrument (¶158).
A person of ordinary skill in the art, seeking to provide a centralized, wireless communications hub for cordless/battery-powered surgical instruments would reasonably consult the multiple embodiments of Scoggins’ as system-based solutions. Scoggins’ battery powered instrument can be incorporated alongside the embodiment of ultrasound surgical instruments utilizing a communications hub without redesigning Scoggin’s core devices (¶¶71, 150). Because the different embodiments of Scoggins are interrelated, overlap, and address the same engineering problem (reusable battery-powered ultrasonic medical devices comprising control modules capable of receiving and utilizing functional data about the device) and Scoggins expressly teaches that medical device 100 may be similar to or representative of ultrasonic medical device 10 (¶150), the proposed modifications relevant to embodiment 100 are mechanically compatible and implemented by routine engineering practices (adding or substituting a battery-powered motor or a control system linked to a wireless communication hub). Accordingly, 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 based on the express teachings in Scoggins. The level of ordinary skill in the art is a person having a BS in EE/ME/BME and 2-5 years in surgical instrument systems and HMI/telemetry.
Regarding claim 14, Scoggins teaches the surgical system according to claim 13, as set forth above, wherein the at least one replaceable component is a battery assembly (¶¶75, 156, 159).
Regarding claim 15, Scoggins teaches the surgical system according to claim 14, as set forth above, 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 teaches the surgical system according to claim 14, as set forth above, 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 teaches the surgical system according to claim 14, as set forth above, wherein the information includes an indication that a state of charge of the battery assembly is below a threshold value (¶¶158-159).
Regarding claim 18, Scoggins teaches the surgical system according to claim 13, as set forth above, wherein the output includes display of at least one step for replacing the at least one replaceable component (¶¶158-159).
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Shelton et al., US 20190125458 (2 May 2019) teaches surgical instruments comprising a smart electrical system.
Fitzsimmons et al., US 20190223850 (1 April 2019) teaches end of life transmission system for surgical instruments.
Smith et al., US 20090057369 (5 March 2009) teaches electrically self-powered surgical instrument with manual release.
Shelton et al., US 2020405301 (31 December 2020) teaches method for authenticating the compatibility of a staple cartridge with a surgical instrument.
Stritch, US 20190298404 (3 October 2019) teaches surgical systems and tools for moving energy applicators in superimposed modes.
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-W (9am-9pm CST) and R-F (9am-3pm 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 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771