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 .
Response to Amendment
Receipt is acknowledged of an amendment, filed 03 December 2025, which has been placed of record and entered in the file.
Status of the claims:
Claims 1-20 are pending.
Claims 9-17 are amended.
Specification and Drawings:
Amendments to the specification have not been submitted in the amendment filed 03 December 2025.
Amendments to the drawings have been submitted in the amendment filed 03 December 2025.
Election/Restrictions
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03 December 2025.
Drawings
Receipt is acknowledged of replacement sheets of drawings, filed 03 December 2025. The drawings are accepted by the examiner.
Claim Objections
Claims 17-20 are objected to because of the following informalities:
In claim 17, line 2, the phrase “the device comprising a processor” is repeated.
Appropriate correction is required.
Claims 18-20 depend from claim 17 and are likewise rejected.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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 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 rejections of claims 9-20 under 35 U.S.C. 112(a) and (b), the claim amendments and applicant’s arguments have been fully considered and are persuasive. The rejections are hereby withdrawn.
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 Linda J. Hodge whose telephone number is (571)272-0571. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/LINDA J. HODGE/Examiner, Art Unit 3731