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, see Remarks, filed 06/18/2026, with respect to the rejection(s) of claim(s) 1 and 10 under U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Shelton (US 2017/0202591 A1) in view of Datta (US 2010/0168676 A1).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4, 6, 12, 13, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2 and 12 recite the limitations “determining, based on the electrical data, a tissue characteristic of a tissue” and “determine a tissue characteristic based on the electrical data” respectively. These limitations render the claims unclear as to if the determined tissue characteristic is the operational parameter of claim 1, or a new determined value/variable. For the purpose of examination, the “tissue characteristic” of claims 2 and 12 is interpreted as referring to the “operational parameter” of claim 1.
Claims 3 and 13 recite the limitations “determining, based on the electrical data, an impedance associated with a tissue” and “determine, based on the electrical data, an impedance associated with a tissue” respectively. These limitations render the claims unclear as to if the determined impedance is the operational parameter of claim 1, or a new determined value/variable. For the purpose of examination, the “tissue characteristic” of claims 3 and 13 is interpreted as referring to the “operational parameter” of claim 1.
Claim 4 recites the limitation “determining, based on the electrical data, a density associated with a tissue.” This limitation renders the claim unclear as to if the determined density is the operational parameter of claim 1, or a new determined value/variable. For the purpose of examination, the “density” of claim 4 is interpreted as referring to the “operational parameter” of claim 1.
Claims 6 and 17 recite the limitations “determining, based on the electrical data, that the second surgical instrument was used within a predetermined period of time prior to the actuation event” and “determine, based on the electrical data, that the second surgical instrument was used within a predetermined period of time prior to the actuation event” respectively. These limitations render the claims unclear as to if the determined usage of the second surgical instrument is the operational parameter of claim 1, or a new determined value/variable. For the purpose of examination, the determined usage of the second surgical instrument within a predetermined period of time prior to the actuation event of claims 6 and 16 is interpreted as referring to the “operational parameter” of claim 1.
Claim Rejections - 35 USC § 103
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, and 7-12, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2017/0202591 A1) in view of Datta (US 2010/0168676 A1).
Regarding claim 10, Shelton teaches a surgical instrument (Fig. 1) configured to operate in a first activation mode associated with radio frequency (RF) energy and a second activation mode associated with ultrasonic energy in a surgical site, (Claim 1) the surgical instrument comprising:
a processor (Claim 1: controller) configured to:
monitor electrical data, (Par. [0453] and [0482]);
detect an actuation event of an input source of the surgical instrument; (Par. [0454]-[0456])
select an activation mode from the first activation mode and the second activation mode based on the monitored electrical data; (Par. [0482]) and
deliver, in response to the actuation event, an energy of an energy output modality associated with the activation mode. (Par. [0354]: The user may activate the energy activation button to select between an RF energy mode, an ultrasonic energy mode, or a combination RF and ultrasonic energy mode.)
Shelton, as applied to claim 10 above, further teaches the electrical data can comprise an impedance; (Par. [0453] and [0482]) and the RF energy can comprise bipolar energy. (Par. [0254])
Shelton, as applied to claim 10 above, is silent regarding the electrical data indicates an operational parameter associated with a second surgical instrument.
Datta, in a similar field teaches measuring a catheter configured to measure a proximity of a second catheter in the target treatment zone by measuring electrical data such as impedance; (Par. [0053]) and wherein the electrode of the catheter can be used as either a source or ground electrode for bi-polar ablation with the second catheter. (Par. [0053])
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 Shelton, as applied to claim 10 above, to incorporate the teachings of Datta, and configure the controller of Shelton to use the measured impedance of Shelton to determine a proximity of any other surgical devices within the treatment zone, including a second ablation device, and to configure the electrodes of Shelton to be able to be used as either a source of ground electrode for bi-polar ablation with a second ablation device. Using the measured impedance to detect other surgical devices and their proximities would minimize the risk of multiple devices within the treatment zone interfering with each other during navigation, manipulation, and energy delivery. Configuring the electrodes of Shelton to be able to be used as either a source or ground electrode for bi-polar ablation with a second catheter would increase the number of ablation patterns and treatment options available to the user with the device of Shelton.
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, the combination of Shelton/Datta, as applied to claim 10 above, further teaches the electrical data includes an indication of at least one of an impedance, a temperature, a density, or a force encountered by a jaw of the surgical instrument when in contact with a tissue. (Shelton: Par. [0482])
Regarding claim 12, the combination of Shelton/Datta, as applied to claim 10 above, teaches the processor is further configured to: determine a tissue characteristic based on the electrical data, wherein the tissue characteristic is at least one of: a tissue thickness, an organ associated with the tissue, a tissue composition, a tissue location, an impedance of the tissue, or a density of the tissue, wherein the activation mode is selected further based on the tissue characteristic. (Shelton: Par. [0404] and Claim 13: Tissue thickness is determined based at least partially on tissue impedance)
Regarding method claim 2, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claims 11 and 12, since operation of the prior art relied on to reject apparatus claims 11 and 12 would naturally result in the step of method claim 2 being satisfied.
Regarding claim 14, the combination of Shelton/Datta, as applied to claim 10 above, teaches the actuation event comprises at least one of: an actuation force, a number of actuations, and an actuation duration, wherein the first activation mode is associated with a first actuation event and the second activation mode is associated with a second actuation event. (Shelton: Par. [0454]: The force of the user input is measured to determine a desired energy level including a higher energy level indicating the desire to activate both energy modalities simultaneously)
Regarding method claim 7, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 14, since operation of the prior art relied on to reject apparatus claim 14 would naturally result in the step of method claim 7 being satisfied.
Regarding claim 15, the combination of Shelton/Datta, as applied to claim 10 above, teaches the electrical data is associated with a sub-therapeutic pulse being delivered to a tissue in the surgical site. (Shelton: Claim 6)
Regarding claim 8, the combination of Shelton/Datta, as applied to claim 10 above, teaches the activation mode is selected independent of the actuation event. (Shelton: Par. [0404]: The controller automatically selects the energy modality based on sensed/calculated parameters of the surgical instrument)
Regarding claim 9, the combination of Shelton/Datta, as applied to claim 10 above, teaches the electrical data includes an indication that a transaction performed using the surgical instrument is complete, wherein, based on the indication, the second activation mode is selected. (Shelton: Par. [0404]: The controller automatically selects the energy modality based on sensed/calculated parameters of the surgical instrument; The communication of incoming sensor data to the controller and outgoing instructions from the controller to the instrument would be considered a transaction.)
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2017/0202591 A1), in view of Datta (US 2010/0168676 A1), as applied to claim 1 above, and further in view of Houser (US 2012/0116391 A1).
Regarding claim 4, the combination of Shelton/Datta, as applied to claim 1 above, teaches
determining a density associated with a tissue in contact with the surgical instrument in the surgical site; (Shelton: Par. [0407]: the tissue density would have to be measured/calculated) and
determining a tissue type of the tissue based the determined density, (Shelton: Par. [0407]) wherein the selected activation mode is further based on the tissue type. (Shelton: Claim 13: Thick tissue, intermediate thickness tissue, and thin tissue would be considered different tissue types)
Shelton, as applied to claim 4 above, is silent regarding the density determination being based on the electrical data.
Houser, in a similar field of endeavor, teaches an ultrasonic electrosurgical device configured to determine a tissue density based on at least a tissue thickness and a jaw clamping force. (Par. [0049])
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 Shelton/Datta, as applied to claim 4 above, to incorporate the teachings of Houser, and configure the controller of Shelton to determine the density of the target tissue based at least partially on the tissue thickness and the jaw clamping force. Doing so would be a simple substitution of one density sensing/determining technique for another for the predictable result of determining the density of the target tissue.
Claim(s) 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2017/0202591 A1), in view of Datta (US 2010/0168676 A1), as applied to claims 1 and 10 above respectively, and further in view of Mehta (US 2010/0217254 A1).
Regarding claim 13, the combination of Shelton/Datta, as applied to claim 10 above, teaches the processor is further configured to: determine, based on the electrical data, an impedance associated with a tissue in the surgical site, wherein: when the impedance associated with the tissue is above a threshold value, the first activation mode is selected, and when the impedance associated with the tissue is below the threshold value, the second activation mode is selected. (Shelton: Claim 15)
The combination of Shelton/Datta, as applied to claim 10 above, is silent regarding the impedance being determined based on the electrical data.
Mehta, in a similar field of endeavor, teaches calculating an impedance using a measured voltage and current. (Par. [0135])
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 Shelton/Datta, as applied to claim 13 above, to incorporate the teachings of Mehta, and calculate the impedance of Shelton using a measured voltage and a measured current. Doing so would be a simple substitution of one impedance determining technique for another for the predictable result of determining a tissue impedance.
Regarding method claim 3, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 13, since operation of the prior art relied on to reject apparatus claim 13 would naturally result in the step of method claim 3 being satisfied.
Allowable Subject Matter
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Claims 5, 6, and 16 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
Claim 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record fails to explicitly teach all of the limitations of claim 1 and further teach the limitation “determining, based on the electrical data, that a surgical stapling device separate from the surgical instrument was used within a predetermined period of time prior to the actuation event; and generating a warning indication of selecting the first activation mode in close proximity to the surgical stapling device.”
The prior art of record fails to explicitly teach all of the limitations of claim 1 and further teach the limitation “determining, based on the electrical data, that a surgical stapling device separate from the surgical instrument was used within a predetermined period of time prior to the actuation event, wherein the second surgical instrument is the surgical stapling device; and generating a warning indication of selecting the first activation mode based on the use of the surgical stapling device within the predetermined period of time.”
The prior art of record fails to explicitly teach all of the limitations of claim 10 and further teach the limitation “wherein the operational parameter associated with the second surgical instrument indicates a use time of the second surgical instrument, wherein the second surgical instrument is separate from the surgical instrument, and wherein, based on the use time occurring within a predetermined period of time prior to the actuation event, the second activation mode is selected.”
The prior art of record fails to explicitly teach all of the limitations of claim 10 and further teach the limitation “wherein the processor is further configured to: determine, based on the electrical data, that the second surgical instrument was used within a predetermined period of time prior to the actuation event; and generate a warning indication of selecting the first activation mode based on the use of in close proximity to the second surgical instrument within the predetermined period of time.”
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 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.
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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
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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