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 .
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement(s) (IDS), filed 20 April 2026, which have been placed of record in the file. An initialed, signed, and dated copy of each PTO-1449 or PTO-SB-08 form is attached to the Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 April 2026 has been entered.
Response to Amendment
Receipt is acknowledged of an amendment, filed 20 April 2026, which has been placed of record and entered in the file.
Status of the claims:
Claims 1-20 are pending.
Claim 17 is amended.
Claims 1-8 are withdrawn from consideration.
Specification and Drawings:
Amendments to the specification and drawings have not been submitted in the amendment filed 20 April 2026.
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.
Claims 9-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harris et al. (US Patent Publ. No. 2019/0200981).
With respect to claim 9, Harris et al. disclose a surgical stapling device for monitoring and adapting to tissue tension during a surgical stapling procedure (figs. 1, 25), the surgical stapling device comprising a processor (controller 461 includes a processor 462, [0442]), and a sensor operably connected to the processor (sensor 474 connected to processor 462, [0454]), wherein the sensor is configured to measure strain on at least one component of the surgical stapling device resultant from one or more of an opposed force applied by a user and a force resisted by tissue associated with the tissue tension (sensor 474 is a strain gauge that measures strain exerted on the anvil during clamping that is indicative of the tissue compression on the tissue clamped between the jaws, [0454], [0455]), wherein the processor is configured to: determine a location of the tissue tension based on historical surgical data, the opposed force, and the force resisted by the tissue associated with the tissue tension (segmented electrodes on cartridge deck determine tissue location with respect to the jaws, sensors and tissue identification process determine location of tissue with respect to the patient based on historical data from databases, [0490], [0725], [0728]-[0730], [0734], [0783]); and highlight the location of the tissue tension to aid in real-time surgical decision-making (the determined location of the tissue and tissue compression is displayed on a visual feedback device to perform diagnostic steps during a surgical procedure, [0013], [0381], [0716], [0770], [0978]).
With respect to claim 10, Harris et al. disclose the historical surgical data is retrieved from a previous surgery (data includes previous surgical procedures, [0757]), and wherein the historical surgical data enhances the determination of the location of the tissue tension (historical surgical data provides contextualized information and suggestions to a surgeon, [0725]).
With respect to claim 11, Harris et al. disclose the determined location of the tissue tension is associated with macro tension (sensors detect a nerve bundle within tissue clamped between the jaws of the end effector, [0774]), and wherein the macro tension affects anatomic structures (clamping of the tissue and the nerve bundle compresses the nerve bundle and increases heart rate monitored by heart rate monitor integrated in the end effector, [0774]), and wherein the processor is further configured to: highlight the location of the tissue tension in relation to the macro tension affecting the anatomic structures (control circuit prevents firing, and alerts operator, [0774]).
With respect to claim 12, Harris et al. disclose the determined location of the tissue tension is associated with micro tension (sensor 474 is a strain gauge that measures strain exerted on the anvil during clamping that is indicative of the tissue compression on the tissue clamped between the jaws, [0454], [0455]), and wherein the micro tension affects a local tissue load (the tissue clamped between the jaws, [0454], [0455]), and wherein the processor is further configured to: highlight the location of the tissue tension in relation to the micro tension affecting the local tissue load (the determined location of the tissue and tissue compression is displayed on a visual feedback device, [0013], [0381], [0716], [0770], [0978]).
With respect to claim 13, Harris et al. disclose the processor is further configured to: determine variable tissue compression (flex circuit 25706 detects absence of tissue and presence of compressed tissue, figs. 153-154, [0988]), wherein the variable tissue compression is indicative of tissue extending beyond a staple pattern onto a nose of a stapling device cartridge of the surgical stapling device while the tissue is located beneath an anvil tip portion of the surgical stapling device (tissue overhang is detected, figs. 151-154, [0985]); and determine an incomplete vessel capture within the staple pattern based on the variable tissue compression (blood vessel grasped between the jaws extends beyond an optimal treatment region of the end effector, figs. 151-154, [0985]).
With respect to claim 14, Harris et al. disclose the determination of the location of tissue tension is further based on a movement of a cutting instrument and a resulting cut line length from the movement (additional sensors measure the firing force of the I-beam with cutting edge for the firing stroke, [0454], [0610]).
With respect to claim 15, Harris et al. disclose the strain is determined using the sensor, and wherein the sensor is configured to measure the strain, and wherein the sensor is integrated within the surgical stapling device (sensor 474 is a strain gauge that measures strain exerted on the anvil during clamping that is indicative of the tissue compression on the tissue clamped between the jaws, sensors are located on the cartridge deck, [0454], [0455], [0490]).
With respect to claim 16, Harris et al. disclose the processor is further configured to: modify the surgical stapling procedure based on the highlighted tissue tension location (the determined location of the tissue and tissue compression is displayed on a visual feedback device to perform diagnostic steps during a surgical procedure, [0013], [0381], [0716], [0770], [0978]), wherein the modification comprises decreasing a potential tissue damage risk from macro or micro tensions (sensor 474 is a strain gauge that measures strain exerted on the anvil during clamping that is indicative of the tissue compression on the tissue clamped between the jaws, [0454], [0455]), damage to tissue is minimized, [0525], [0793], [0811], [0861]).
With respect to claim 17, Harris et al. disclose a device for monitoring and adapting to tissue tension during a surgical stapling procedure (figs. 1, 25), the device comprising a processor, the device comprising a processor (controller 461 includes a processor 462, [0442]) and a sensor operably connected to the processor (sensor 474 connected to processor 462, [0454]), wherein the sensor is configured to measure strain on at least one component of the device resultant from a force applied during the surgical stapling procedure (sensor 474 is a strain gauge that measures strain exerted on the anvil during clamping that is indicative of the tissue compression on the tissue clamped between the jaws, [0454], [0455]), wherein the processor is configured to: determine a location of the tissue tension based on historical surgical data and the force applied during the surgical stapling procedure (segmented electrodes on cartridge deck determine tissue location with respect to the jaws, sensors and tissue identification process determine location of tissue with respect to the patient based on historical data from databases, [0490], [0725], [0728]-[0730], [0734], [0783]); and highlight the location of the tissue tension to aid in real-time surgical decision-making (the determined location of the tissue and tissue compression is displayed on a visual feedback device to perform diagnostic steps during a surgical procedure, [0013], [0381], [0716], [0770], [0978]).
With respect to claim 18, Harris et al. disclose the historical surgical data is retrieved from a previous surgery (data includes previous surgical procedures, [0757]), and wherein the historical surgical data enhances the determination of the location of the tissue tension (historical surgical data provides contextualized information and suggestions to a surgeon, [0725]).
With respect to claim 19, Harris et al. disclose the determined location of the tissue tension is associated with macro tension (sensors detect a nerve bundle within tissue clamped between the jaws of the end effector, [0774]), and wherein the macro tension affects anatomic structures (clamping of the tissue and the nerve bundle compresses the nerve bundle and increases heart rate monitored by heart rate monitor integrated in the end effector, [0774]), and wherein the processor is further configured to: highlight the location of the tissue tension in relation to the macro tension affecting the anatomic structures (control circuit prevents firing, and alerts operator, [0774]).
With respect to claim 20, Harris et al. disclose the determined location of the tissue tension is associated with micro tension (sensor 474 is a strain gauge that measures strain exerted on the anvil during clamping that is indicative of the tissue compression on the tissue clamped between the jaws, [0454], [0455]), and wherein the micro tension affects a local tissue load (the tissue clamped between the jaws, [0454], [0455]), and wherein the processor is further configured to: highlight the location of the tissue tension in relation to the micro tension affecting the local tissue load (the determined location of the tissue and tissue compression is displayed on a visual feedback device, [0013], [0381], [0716], [0770], [0978]).
Response to Arguments
With respect to the objection to claims 17-20, the claim amendments and applicant’s arguments have been fully considered and are persuasive. The objection is hereby withdrawn.
With respect to the rejection of Claims 9 and 17 under 35 U.S.C. 102(a)(1) as being anticipated by Harris et al. (US Patent Publ. No. 2019/0200981), applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that Harris et al. disclose that historical data is used for contextual interpretation or control selection, and not as an input to a determination of a spatial location of tissue tension.
However, Harris et al. specifically disclose that the processor uses historical data to “determine a location of the tissue tension”. In this regard, Harris et al. disclose that the processor uses historical data and sensor data to determine information including “the body cavity that is the subject of the procedure” ([0725]), “rotation, articulation” of the shaft assembly ([0734]), and identity of the tissue as “bronchus” ([0783]). The particular body cavity determines a location of tissue tension with respect to the patient. The rotation/articulation of the instrument determines a location of tissue tension with respect to the instrument. The identity of the tissue as bronchus determines a location of tissue tension with respect to the patient. Therefore, the body cavity, the rotation/articulation of the instrument, and the identity of the tissue as bronchus, each “determine a location of the tissue tension based on historical surgical data, the opposed force, and the force resisted by the tissue associated with the tissue tension” as claimed.
Applicant further argues that Harris et al. does not teach “highlighting the location of the tissue tension to aid in real-time surgical decision-making”.
However, Harris et al. specifically disclose “displaying the determined location of the compressed tissue on a visual feedback device” ([0013]), a visualization system to “display a snapshot of surgical site, as recorded by an imaging device 124, on a non-sterile display 107 or 109, while maintaining a live feed of the surgical site on the primary display 119” ([0381]), a user interface to inform the surgeon when the end effector is properly located by a video image with a digital overlay for the surgeon to visually confirm that the end effector is positioned at the target site and to aid the surgeon in navigation ([0770]). Therefore, since Harris et al. disclose that the location of tissue tension is displayed on a video monitor, and that the surgeon may use the display to navigate the instrument, then Harris et al. is considered to disclose “highlighting the location of the tissue tension to aid in real-time surgical decision-making”.
Accordingly, in view of all of the above, the rejection of claims 9 and 17 under 35 U.S.C. 102(a)(1) over Harris et al. (US Patent Publ. No. 2019/0200981) is still deemed proper.
Applicant has provided no arguments pointing out errors with respect to the rejections of dependent claims 10-16 and 18-20, and these rejections are still deemed proper.
Conclusion
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/LINDA J. HODGE/Primary Examiner, Art Unit 3731
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