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 .
Continued Examination Under 37 CFR 1.114
In view of the appeal brief filed on 04/24/2026, PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/JOSEPH A STOKLOSA/ Supervisory Patent Examiner, Art Unit 3794
Response to Arguments
Applicant’s arguments, see Appeal Brief, filed 04/24/2026, with respect to claims 1-20 have been fully considered and are persuasive. The pervious rejection of claims 1-20 has been withdrawn. However, a new rejection has been made in view of Francischelli (US 20050256522 A1) and Harris (US 20190200981 A1).
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Francischelli (US 20050256522 A1).
Regarding claim 1, Francischelli teaches a surgical system, comprising: a surgical instrument, comprising: an end effector (Fig 2; ablation head 14 has a pair of jaws 24, 26); a first drive system ([0031] force meter 50 is incorporated into ablation head 14. The force meter 50 provides a measurement of the force being applied between jaws 24, 26 on material, such as tissue placed between jaws 24, 26) ([0032] the jaws 24, 26 are closed by depressing trigger 16 (see FIG. 1). In such a case, a user may apply a certain amount of force to trigger 16 resulting in an appropriate force between jaws 24, 26 as indicated by force meter 50); and a second drive system different from the first drive system ([0039] During the application of RF energy to create the ablation lesion, saline may be applied to the ablation area between electrodes 28) ([0040] Once an RF energy and force of application have been selected and the tissue thickness has been determined, a surgeon may determine the time of energy application necessary to accomplish the goal of a transmural lesion. The time may be selected from experimental results for a particular type of tissue); and a control system ([0026] Further referring to FIG. 1, in an exemplary embodiment of a tissue ablation system, bipolar ablation device 10 may be partially controlled by and may provide feedback to a control device, such as generator 22), configured to: detect the actuation of the first drive system of the surgical instrument ([0032] The force meter 50 may provide a direct indication of the force being applied between the electrodes 28 or may alternatively provide an electronic signal representative of the force to another instrument, such as generator 22, which may then convert the electronic signal into a reading representative of the force being applied. In one embodiment, the jaws 24, 26 are closed by depressing trigger 16 (see FIG. 1). In such a case, a user may apply a certain amount of force to trigger 16 resulting in an appropriate force between jaws 24, 26 as indicated by force meter 50); drive a first function of the end effector using the first drive system ([0032]); monitor a first parameter associated with the first function driven by the first drive system ([0032] force being applied between the electrodes 28); set a second parameter associated with a second function of the end effector based on the monitored first parameter ([0040] Once an RF energy and force of application have been selected and the tissue thickness has been determined, a surgeon may determine the time of energy application necessary to accomplish the goal of a transmural lesion. The time may be selected from experimental results for a particular type of tissue); and drive the second function of the end effector using the second drive system ([0040]).
Regarding claim 1, Francischelli teaches the surgical system of Claim 1, wherein: the end effector comprises a jaw movable between an open position and a clamped position (Fig 3; ablation head 14 has a pair of jaws 24, 26); the first function comprises transitioning the jaw of the end effector toward the clamped position ([0032] the jaws 24, 26 are closed by depressing trigger 16 (see FIG. 1). In such a case, a user may apply a certain amount of force to trigger 16 resulting in an appropriate force between jaws 24, 26 as indicated by force meter 50); and the first parameter comprises a load applied by the jaw to tissue positioned within the end effector ([0031] The force meter 50 provides a measurement of the force being applied between jaws 24, 26 on material, such as tissue placed between jaws 24, 26).
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.
Claim(s) 3-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francischelli (US 20050256522 A1) in view of Harris (US 20190200981 A1).
Regarding claim 3, Francischelli teaches the surgical system of Claim 2, but fails to teach wherein the end effector comprises a staple cartridge comprising staples removably stored therein; the surgical instrument further comprises a firing member movable from an unfired position toward a fired position; the staples are deployable from the staple cartridge based on the firing member moving toward the fired position the second function comprises driving the firing member toward the fired position; and the second parameter comprises a speed of the firing member.
However, Harris teaches wherein the end effector comprises a staple cartridge comprising staples removably stored therein (Fig 17; a removable staple cartridge 718); the surgical instrument further comprises a firing member movable from an unfired position toward a fired position ([0505] When ready to use the instrument 750, the clinician may provide a firing signal, for example by depressing a trigger of the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal stroke begin position to a stroke end position distal of the stroke begin position); the staples are deployable from the staple cartridge based on the firing member moving toward the fired position ([0462] The firing motor 602 may be operably coupled to a firing motor drive assembly 604 which can be configured to transmit firing motions, generated by the motor 602 to the end effector, in particular to displace the I-beam element. In certain instances, the firing motions generated by the motor 602 may cause the staples to be deployed from the staple cartridge into tissue captured by the end effector and/or the cutting edge of the I-beam element to be advanced to cut the captured tissue, for example); the second function comprises driving the firing member toward the fired position ([0462]); and the second parameter comprises a speed of the firing member ([0506] A firing control program may describe the distal motion of the displacement member. Different firing control programs may be selected to better treat different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a lower velocity and/or with lower power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher velocity and/or with higher power). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Francischelli to include wherein the end effector comprises a staple cartridge comprising staples removably stored therein; the surgical instrument further comprises a firing member movable from an unfired position toward a fired position; the staples are deployable from the staple cartridge based on the firing member moving toward the fired position the second function comprises driving the firing member toward the fired position; and the second parameter comprises a speed of the firing member. Doing so allows for an additional function of the jaws to open and close with a staple cartridge for an effective procedure.
Regarding claim 4, Francischelli teaches the surgical system of Claim 1, wherein: the end effector comprises an energy delivery component ([0027] ablation head 14 has a pair of jaws 24, 26. One or both of the jaws 24, 26 may have an ablative element for ablating tissue).
Francischelli fails to teach the first function comprises applying energy to tissue positioned within the end effector with the energy delivery component; and the first parameter comprises an amount of time that energy has been applied to the tissue.
However, Harris teaches the first function comprises applying energy to tissue positioned within the end effector with the energy delivery component ([0751] the staple cartridge may comprise an active electrode to deliver electrosurgical energy (e.g., RF energy) to the grasped tissue and at least a portion of the anvil may act as a return electrode); and the first parameter comprises an amount of time that energy has been applied to the tissue ([0611] if the end effector 151340 includes electrodes coupled to an RF energy source, the electrical impedance of the tissue increases as energy is delivered through the tissue between the anvil 151306 and the staple cartridge 151304 of the end effector 151340) ([0611] The sensors may be adapted and configured to measure tissue impedance “Z” over time “t” as represented graphically in FIG. 48) ([0752] a generator producing the electrosurgical energy and/or a sensor, e.g., 23134, integrated in the surgical instrument may be configured to detect when impedance between the electrodes falls below a threshold value for a threshold time period (i.e., impedance drop indicative of a short)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Francischelli to include the first function comprises applying energy to tissue positioned within the end effector with the energy delivery component; and the first parameter comprises an amount of time that energy has been applied to the tissue. Doing so allows for effective application of energy based on the tissue type or thickness.
Regarding claim 5, Francischelli teaches the surgical system of Claim 4, wherein the energy delivery component comprises an electrode ([0027] FIG. 2, ablative elements are shown as linear electrodes 28, that are used to impart RF energy to tissue for ablation purposes).
Regarding claim 6, Francischelli teaches the surgical system of Claim 4, but fails to teach wherein the energy delivery component comprises an ultrasonic blade.
However, Harris teaches wherein the energy delivery component comprises an ultrasonic blade ([0791] the disclosed aspects similarly apply to other surgical instruments including energy devices (e.g. RF and/or ultrasonic surgical instruments)) ([0720] It should be noted that surgeons regularly switch back and forth between surgical stapling/cutting instruments and surgical energy (i.e., RF or ultrasonic) instruments depending upon the particular step in the procedure because different instruments are better adapted for particular tasks). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Francischelli to include wherein the energy delivery component comprises an ultrasonic blade. Doing so allows for dual function of the surgical device for a more precise ablation.
Regarding claim 7, Francischelli teaches the surgical system of Claim 4, wherein: the end effector comprises a jaw movable between an open position and a clamped position (Fig 3; ablation head 14 has a pair of jaws 24, 26); the second function comprises transitioning the jaw toward the clamped position ([0032] the jaws 24, 26 are closed by depressing trigger 16 (see FIG. 1). In such a case, a user may apply a certain amount of force to trigger 16 resulting in an appropriate force between jaws 24, 26 as indicated by force meter 50); and the second parameter comprises a load applied by the jaw to the tissue positioned within the end effector ([0031] The force meter 50 provides a measurement of the force being applied between jaws 24, 26 on material, such as tissue placed between jaws 24, 26).
Regarding claim 8, Francischelli teaches the surgical system of Claim 1, wherein: the end effector comprises an energy delivery component ([0027] FIG. 2, ablative elements are shown as linear electrodes 28, that are used to impart RF energy to tissue for ablation purposes); the first function comprises applying energy to tissue positioned within the end effector with the energy delivery component ([0034] An electrode energy is then selected along with a desired degree of force to be applied to tissue 70 between jaws 24, 26).
Francischelli fails to teach the first parameter comprises a change in impedance of the tissue over time.
However, Harris teaches the first parameter comprises a change in impedance of the tissue over time (FIG. 48 is an illustrative graph of impedance over time). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Francischelli to include the first parameter comprises a change in impedance of the tissue over time. Doing so allows for a visual indication of the procedure in real time for accurate changes in impedance.
Regarding claim 9, Francischelli teaches the surgical system of Claim 8, wherein the energy delivery component comprises an electrode ([0027] FIG. 2, ablative elements are shown as linear electrodes 28, that are used to impart RF energy to tissue for ablation purposes).
Regarding claim 10, Francischelli teaches the surgical system of Claim 8, but fails toteach wherein the energy delivery component comprises an ultrasonic blade.
However, Harris teaches wherein the energy delivery component comprises an ultrasonic blade ([0791] the disclosed aspects similarly apply to other surgical instruments including energy devices (e.g. RF and/or ultrasonic surgical instruments)) ([0720] It should be noted that surgeons regularly switch back and forth between surgical stapling/cutting instruments and surgical energy (i.e., RF or ultrasonic) instruments depending upon the particular step in the procedure because different instruments are better adapted for particular tasks). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Francischelli to include wherein the energy delivery component comprises an ultrasonic blade. Doing so allows for dual function of the surgical device for a more precise ablation.
Regarding claim 11, Francischelli teaches the surgical system of Claim 8, wherein: the end effector comprises a jaw movable between an open position and a clamped position (Fig 3; ablation head 14 has a pair of jaws 24, 26); the second function comprises transitioning the jaw toward the clamped position ([0032] the jaws 24, 26 are closed by depressing trigger 16 (see FIG. 1). In such a case, a user may apply a certain amount of force to trigger 16 resulting in an appropriate force between jaws 24, 26 as indicated by force meter 50); and the second parameter comprises a load applied to the tissue positioned within the end effector ([0031] The force meter 50 provides a measurement of the force being applied between jaws 24, 26 on material, such as tissue placed between jaws 24, 26).
Allowable Subject Matter
Claims 12-20 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights