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 .
A complete action on the merits of pending claims 1-17 appears herein.
Response to Arguments
Applicant's arguments filed 06/18/2026 have been fully considered but they are not persuasive.
Applicant argues “The Office Action at page 4 asserts that ‘determine a surgical task,’ is disclosed at least by paragraph [0412] of Shelton in that ‘Jaw force and jaw gap distance are used to determine tissue thickness; Treating a thick tissue, and intermediate thickness tissue, or a thin tissue would be considered different surgical tasks,’ however, this characterization in the Office Action is erroneous. The recited portions of Shelton simply mention a tissue thickness based on a jaw gap distance, namely whether there is thick, intermediate, or thin tissue. Tissue thickness is a passive, physical property of the tissue, it is not a surgical task and nowhere in the Office Action or in the cited portions of Shelton is there any mention of a ‘surgical task,’ much less ‘determining a surgical task based on the mechanical data,’ as claimed.”
Examiner respectfully disagrees. Looking to applicant’s presently filed specification, there appears to be no definition provided for the term “surgical task.” Given broadest reasonable interpretation, treating a thin tissue, treating an intermediate tissue, and treating a thick tissue can each be considered individual “surgical tasks” as each would be considered a separate goal and would require different operational and energy delivery parameters. Shelton teaches selecting/controlling energy modalities based at least partially on tissue thickness. (Par. [0145])
Applicant further argues “This cited portion of Shelton fails to recite a selection, an activation mode, or a surgical task, much less selecting an activation mode based at least on the determined surgical task, and the Office Action is completely silent as to any explanation of how claim 13 describes the recited selection. Therefore, it cannot be said that Shelton discloses, ‘selecting, based at least on the surgical task and the mechanical data, an activation mode,’ as recited in amended claim 1.”
Examiner respectfully disagrees and contends that, as discussed above, treating a thin tissue, treating an intermediate tissue, and treating a thick tissue can each be considered their own “surgical tasks.” As further discussed in the rejection to claim 10 below, Shelton591 teaches selecting an energy modality based at least partially on a thickness of a target tissue. (Par. [0145])
Regarding claim 13, Shelton teaches determining the presence/absence of tissue between the jaw members and controlling energy based on said determination such that only the segments of the jaws where tissue is detected is energized. (Par. [0478]) In doing so, parameters of the activation mode are controlled/selected based on said presence/absence determination.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 4, and 9-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton (hereinafter Shelton591) (US 2017/0202591 A1).
Regarding claim 10, Shelton591 teaches a surgical instrument configured to operate in a first activation mode associated with radio frequency (RF) energy or a second activation mode associated with ultrasonic energy, (Fig. 1 and Claim 1) the surgical instrument comprising:
a processor (Claim 1: controller) configured to:
monitor mechanical data associated with the surgical instrument; (Par. [0404]: Jaw gap sensing)
determine a surgical task based on the mechanical data associated with the surgical instrument; (Par. [0145]: The energy modality and energy delivery may be selectable based at least partially on tissue thickness and/or type; [0412]: A differentiation is made between a thin tissue, a thick tissue, and an intermediate tissue using a sensed jaw gap; Treating a thin tissue, an intermediate tissue, or a thick tissue can be interpreted as different surgical tasks, as each would be considered different goals and would require different operational/energy parameters.)
detect an actuation event of an input source of the surgical instrument; (Par. [0454]-[0456])
select, based at least on the surgical task and the mechanical data, an activation mode from the first activation mode and the second activation mode; (Claim 9) and
deliver, in response to the actuation event, an energy of an energy output modality associated with the selected activation mode. (Par. [0454]-[0456] and Claim 9)
Regarding method claim 1, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 10, since operation of the prior art relied on to reject apparatus claim 10 would naturally result in the step of method claim 1 being satisfied.
Regarding claim 11, Shelton591 further teaches the mechanical data comprises a jaw gap position indication associated with a jaw of the surgical instrument and a jaw force indication associated with the jaw, wherein the activation mode is selected further based on the jaw gap position indication and the jaw force indication. (Par. [0453]: A tissue characteristic (thickness) is used to start application of and/or switch between RF and ultrasonic energy; Par. [0412]: Jaw force and jaw gap distance are used to determine tissue thickness)
Regarding method claims 2 and 4, the claims are rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 11, since operation of the prior art relied on to reject apparatus claim 11 would naturally result in the step of method claims 2 and 4 being satisfied.
Regarding claim 12, Shelton591 further teaches the processor is further configured to: determine the surgical task based on the jaw gap position indication and the jaw force indication, a surgical task, (Par. [0412]: Jaw force and jaw gap distance are used to determine tissue thickness; Treating a thick tissue, an intermediate thickness tissue, or a thin tissue would be considered different surgical tasks) wherein the activation mode is selected further based on the determined surgical task. (Claim 13; and Par. [0145])
Regarding claim 13, Shelton591 further teaches the mechanical data further comprises a tissue presence indication indicating whether a tissue is present within a jaw of the surgical instrument, wherein the activation mode is selected further based on the tissue presence indication. (Par. [0477]-[0478])
Regarding claim 14, Shelton591 further teaches the processor is further configured to: determine a blade deflection indication based on a displacement of a blade of the surgical instrument from an original position, and wherein the activation mode is selected further based on the blade deflection indication. (Par. [0406]: The displacement that the knife or closure system can reach is measured to determine a tissue thickness; Par. [0453]: Tissue thickness is used to start and switch application of RF and ultrasonic energy)
Regarding claim 15, Shelton591 further teaches wherein the actuation event is based on at least one of: an actuation force, a number of actuations, an actuation duration, and wherein the first activation mode is associated with a first actuation event, and the second activation mode is associated with a second actuation event. (Par. [0454]: The higher energy level could indicate the desire to activate both energy modalities simultaneously)
Regarding method claim 9, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 15, since operation of the prior art relied on to reject apparatus claim 15 would naturally result in the step of method claim 9 being satisfied.
Regarding claim 16, Shelton591 further teaches a surgical procedure comprises the surgical task, and wherein the surgical task is at least one of feathering, tissue marching, or transection. (Par. [0485]: The ultrasonic blade can be operated to cut tissue)
Regarding claim 17, Shelton591 further teaches determining, based on the mechanical data, a status associated with the surgical task, wherein the status indicates a relative progress of the surgical task; and selecting the activation mode further based on the status. (Par. [0456])
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.
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(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2017/0202591 A1), as applied to claim 2 above, and further in view of Worrell (US 2017/0238991 A1).
Regarding claim 3, Shelton591, as applied to claim 2 above, teaches the mechanical data further comprises a tissue presence indication associated with the jaw, wherein selecting the activation mode comprises: (Par. [0478])
upon the jaw gap position indication indicating that the jaw of the surgical instrument is closed and the tissue presence indication indicating a tissue is present when the actuation event is detected, selecting the first activation mode; (Par. [0478])
Shelton591, as applied to claim 2 above, is silent regarding upon the jaw gap position indication indicating that the jaw of the surgical instrument is closed and the tissue presence indication indicating no tissue is present when the actuation event is detected, selecting the second activation mode.
Worrell, in a similar field of endeavor, teaches a generator configured to switch from an RF energy delivery mode to an ultrasonic energy delivery mode in the event that a short circuit condition may appear. (Par. [0591])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Shelton591, as applied to claim 1 above, to incorporate the teachings of Worrell, and select the ultrasonic activation mode upon determination that a short circuit condition is likely, such as when the jaw is closed and no tissue is present. Doing so would ensure that tissue can be sealed effectively without risking damage to the device caused by delivery of RF energy during a short circuit condition.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton591 (US 2017/0202591 A1), as applied to claim 4 above, in view of Neurohr (US 2016/0074061 A1).
Regarding claim 5, Shelton591, as applied to claim 4 above, teaches determining a detected load based on the jaw force indication, (Fig. 1 and Par. [0480] and Par. [0453]: The force applied to the jaw member (114) would be considered a load)
Shelton591, as applied to claim 4 above, is silent regarding wherein selecting the activation mode comprises, upon the detected load being less than a threshold load and a jaw gap position indication indicating the jaw is open, selecting the second activation mode.
Neurohr, in a similar field of endeavor, teaches an ultrasonic blade device configured to transition between a first configuration in which an ultrasonic blade is used to clamp tissue between said blade and a jaw member and a second configuration in which said jaw member is retracted and said ultrasonic blade operates like a scalpel. (without clamping tissue) (Fig. 13A-B and Par. [0116])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the Shelton591, as applied to claim 4 above, to incorporate the teachings of Neurohr, and configure the jaw member (114) of Shelton591 to retract such that ultrasonic blade (116) can be transitioned between a first configuration in which jaw member (114) clamps tissue with ultrasonic blade (116) and a second configuration in which jaw member (114) is retracted and ultrasonic blade operates like a scalpel. (without clamping tissue) Doing so would allow the device to be used in procedures involving tissue too large to be properly clamped by jaw member (114) and ultrasonic blade (116).
In this combination, when jaw member (114) of Shelton591 is retracted and ultrasonic blade (116) of Shelton591 is in the second configuration, the load on jaw member (114) of would be zero, and the jaw would be indicated as open (Neurohr Fig. 3A: there is a gap between clamp pad (362) and the shaft holding blade (352)) and that the user desired to use ultrasonic blade (116) of Shelton591 in the second configuration.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton591 (US 2017/0202591 A1), as applied to claim 4 above, in view of Shelton (hereinafter Shelton931) (US 2019/0059931 A1).
Regarding claim 6, Shelton591, as applied to claim 4 above, teaches determining the surgical task based on a jaw gap position indication and the jaw force (Par. [0412]: Jaw force and jaw gap distance are used to determine tissue thickness; Treating a thick tissue, an intermediate thickness tissue, or a thin tissue would be considered different surgical tasks; Par. [0145]: The energy modality and energy delivery may be selectable based at least partially on tissue thickness and/or type; Treating a thin tissue, an intermediate tissue, or a thick tissue can be interpreted as different surgical tasks, as each would be considered different goals and would require different operational/energy parameters.) and selecting the second activation mode. (Claim 13)
Shelton591, as applied to claim 6 above, is silent regarding the selection of the second activation mode being based at least partially on the surgical task indicating feathering or tissue marching.
Shelton931 teaches delivering ultrasonic energy via an ultrasonic blade to a target tissue to treat said tissue in a feathering treatment according to a feathering treatment protocol based at least partially on a determined tissue thickness. (Claim 19)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Shelton591, as applied to claim 6 above, to incorporate the teachings of Shelton931, and configure ultrasonic energy of Shelton591 to be delivered in a feathering treatment protocol based on the determined tissue thickness. Doing so would increase the number of treatment options available to a user.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton591 (US 2017/0202591 A1), as applied to claim 1 above, in view of Madan (US 2017/0172608 A1).
Regarding claim 7, Shelton591, as applied to claim 1 above, teaches measuring a force applied to an ultrasonic blade and using said measured force to control energy delivery to a target tissue. (Par. [0480] and Par. [0453])
Shelton591, as applied to claim 1 above, is silent regarding determining a blade deflection indication based on a distance between a blade of the surgical instrument and an inner tube of the surgical instrument, wherein the distance is measured using an emitter of the surgical instrument; and wherein selecting the activation mode further comprises, upon the blade deflection indication indicating the blade is deflected when the actuation event is detected, selecting the second activation mode.
Madan, in a similar field of endeavor, teaches determining a blade deflection indication based on a distance between a blade of the surgical instrument and an inner tube of the surgical instrument and using said blade deflection determination to determine a pressure experienced by the blade interacting with tissue, (Par. [0050]) wherein the distance is measured using an emitter of the surgical instrument; (Par. [0050]: Sensor (238) would be considered an emitter at least in that sensor (238) is emitting signals communicating data to a controller).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Shelton591, as applied to claim 1 above, to incorporate the teachings of Madan, and include the sensor (238) of Madan, such that the force applied to the ultrasonic blade of Shelton591 is measured via said sensor (238). Doing so would be a simple substitution of one force measurement mechanism for another for the predictable result of sensing a clamping force applied to tissue.
In this combination, both the first and second activation modes would be selected based at least in part due to the blade deflection indication measured by sensor (238) of Madan, since said indication would be the force measurement used to determine the tissue characteristic used to start and switch between RF and ultrasonic energy as described in Shelton591. (Par. [0453])
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton591 (US 2017/0202591 A1), in view of Madan (US 2017/0172608 A1), as applied to claim 7 above, and further in view of Buchman (US 2006/0058783 A1)
Regarding claim 8, the combination of Shelton591/Madan, as applied to claim 7 above, is silent regarding generating, based on the blade deflection indication, a warning indication that the surgical instrument may require repositioning or a device assessment.
Buchman, in a similar field of endeavor, teaches generating a warning indication to a user based on a measured blade deflection of an ultrasonic blade; wherein said warning comprises that the device may require a device assessment. (Par. [0034]: The notice that a build up of charred tissue on blade (16) would alert a user that blade (16) should be examined and cleaned if necessary to remove said charred tissue)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Shelton591/Madan, as applied to claim 7 above, to incorporate the teachings of Buchman, and generate a warning to a user, based on the blade deflection indication, that the surgical instrument may require a device assessment for charred tissue buildup on said blade. Doing so would minimize the risk of damage to the device or diminished energy delivery efficiency due to excessive buildup of charred tissue on the ultrasonic blade.
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 NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.S.B./Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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