DETAILED ACTION
This action is in response to preliminary amendments received on 03/19/2024. Claims 1-15 were originally filed. Claims 1 and 3-15 have been amended and new claims 16-20 added. A complete action on the merits of claims 1-20 follows below.
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 .
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 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.
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 1-20 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation “a motor control circuit configured to: electrically drive the motor during a clamping time period, monitor a motor parameter of the motor during the clamping time period, and determine an end time of the clamping time period based at least in part on the motor parameter”. It is unclear what is meant by “a clamping time period” and “determining an end time of the clamping time period” and how the motor control circuit monitors a motor parameter of the motor during the clamping time period, and determines an end time of the clamping time period based at least in part on the motor parameter. Clarification and appropriate correction is required.
Claim 5 recites the limitation “the motor control circuit is configured to: compare the motor torque to a motor torque threshold, and determine the end time based at least in part on the comparison of the motor torque to the motor torque threshold”. It is unclear how comparing the motor torque to a motor torque threshold determines “the end time”. Furthermore, it is unclear as “the end time” of what is being determined. Clarification and appropriate correction is required.
Claim 12 recites the limitation “the motor control circuit is configured to determine the end time of the clamping time period based at least in part on the motor parameter and manufacturing calibration parameters of the surgical instrument”. It is unclear how the motor control circuit is configured to determine “the end time of the clamping time period” based at least in part on the motor parameter and manufacturing calibration parameters of the surgical instrument”. Furthermore, it is unclear as “the end time” of what is being determined and how the manufacturing calibration parameters of the surgical instrument plays a role. Clarification and appropriate correction is required.
Claim 13 recites the limitation “the motor control circuit is configured to estimate a peak firing force during the firing stroke based at least in part on the motor parameter monitored during the clamping time period and manufacturing calibration parameters of the surgical instrument”. It is unclear how the motor control circuit is configured to estimate “a peak firing force during the firing stroke based at least in part on the motor parameter monitored during the clamping time period and manufacturing calibration parameters of the surgical instrument”. Furthermore, it is unclear how the manufacturing calibration parameters of the surgical instrument plays a role. Clarification and appropriate correction is required.
Claims 2-4, 6-11 and 14-19 are rejected due to dependency over claim 1.
Claim 20 recites the limitation “a motor control circuit configured to: electrically drive the motor during a plurality of short duration clamping time periods at a plurality of strain rates, monitor a motor parameter of the motor during the plurality of clamping time periods, and determine a tissue parameter based at least in part on the motor parameter during the plurality of clamping time periods”. It is unclear what is meant by “a plurality of short duration clamping time periods at a plurality of strain rates” and if “the plurality of clamping time periods” in line 9 is the same or different than the plurality of short duration clamping time periods earlier introduced in the claim. Furthermore, it is unclear how a tissue parameter is determined based at least in part on the motor parameter during the plurality of clamping time periods. Clarification and appropriate correction is required.
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 1-3, 5-10, 12-15 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton (US 2019/0201146).
Regarding Claim 1, Shelton teaches a surgical instrument 150010 (Fig. 25 or similar stapler instruments in other embodiments) comprising:
an end effector 150300/151030/153502 comprising a pair of jaws (150302, 150306 in Fig. 25 and similar jaws in other embodiments); a motor assembly 710 comprising a motor mechanically coupled to the end effector 150300/151030/153502, the motor assembly being configured to actuate the end effector to grasp and compress tissue between the pair of jaws ([0325] and [0333]); and a motor control circuit 710 configured to:
electrically drive the motor during a clamping time period (t1-t4 in Fig. 83), monitor a motor parameter of the motor during the clamping time period ([0323], [0338], [0698]), and determine an end time (end of t4 in Fig. 83) of the clamping time period based at least in part on the motor parameter (in general see [0333]-[0343], [0532]-[0538], [0547], [0594], [0687], also see [0698]-[0700] and Figs. 83, 96-97).
Regarding Claim 2, Shelton teaches wherein the motor parameter comprises a motor torque ([0333]-[0343], [0538], [0547]).
Regarding Claim 3, Shelton teaches wherein the motor torque is configured to exponentially decay through a predictive portion of the clamping time period ([0333]-[0334]).
Regarding Claim 5, Shelton teaches wherein the motor control circuit is configured to: compare the motor torque to a motor torque threshold, and determine the end time based at least in part on the comparison of the motor torque to the motor torque threshold ([0333]-[0335], [0538]-[0540], [0585], [0594]-[0595]).
Regarding Claim 6, Shelton teaches wherein the pair of jaws comprises an anvil 150306/151034/153516 and a staple jaw 150304/151036/153518, wherein the end effector 150300/151030/153502 is configured to deploy staples 150191/153505 into the tissue during a firing stroke, and wherein the motor control circuit 710 is configured to estimate a peak firing force during the firing stroke based at least in part on the motor parameter monitored during the clamping time period ([0412], [0434]-[0438], [0527]-[0540] and Figs. 25-28, 31-38, 82-83).
Regarding Claim 7, Shelton teaches wherein the pair of jaws comprises an anvil 150306/151034/153516 and a staple jaw 150304/151036/153518, wherein the end effector 150300/151030/153502 is configured to deploy staples 150191/153505 into the tissue during a firing stroke, and wherein the motor control circuit 710 is configured to initiate the firing stroke in response to the clamping time period reaching the end time (at t4 in Fig. 83).
Regarding Claim 8, Shelton teaches wherein the pair of jaws comprises an anvil 150306/151034/153516 and a staple jaw 150304/151036/153518, wherein the end effector 150300/151030/153502 is configured to deploy staples 150191/153505 into the tissue during a firing stroke, and wherein the motor control circuit 710 is configured to set a parameter of the firing stroke based at least in part on the motor parameter of the motor during the clamping time period (force-[0412], [0434]-[0438], [0527]-[0540] and Figs. 25-28, 31-38, 82-83).
Regarding Claim 9, Shelton teaches wherein the motor control circuit is configured to estimate a tissue property based at least in part on the motor parameter of the motor during the clamping time period (thin tissue vs. thick tissue based on the force applied during time period t1, [0532] and Fig. 83, also see [0472]-[0474]).
Regarding Claim 10, Shelton teaches wherein the end effector 151030 /153470 (Figs. 35-38, 75-79) comprises electrodes 151038/151048/configured to deliver thermal treatment to the tissue ([0436]-[0441] and [0512]).
Regarding Claim 12, Shelton teaches wherein the motor control circuit is configured to determine the end time of the clamping time period based at least in part on the motor parameter and manufacturing calibration parameters of the surgical instrument ([0487] and [0527]-[0540]).
Regarding Claim 13, Shelton teaches wherein the pair of jaws comprises an anvil 150306/151034/153516 and a staple jaw 150304/151036/153518, wherein the end effector 150300/151030/153502 is configured to deploy staples 150191/153505 into the tissue during a firing stroke, and wherein the motor control circuit 710 is configured to estimate a peak firing force during the firing stroke based at least in part on the motor parameter monitored during the clamping time period and manufacturing calibration parameters of the surgical instrument ([0412], [0434]-[0438], [0527]-[0540] and Figs. 25-28, 31-38, 82-83).
Regarding Claim 14, Shelton teaches wherein the pair of jaws comprises an anvil 150306/151034/153516 and a staple jaw 150304/151036/153518, wherein the end effector 150300/151030/153502 is configured to deploy staples 150191/153505into the tissue during a firing stroke, and wherein the motor control circuit 710 is configured to calculate a pause duration at the end of the firing stroke based at least in part on the motor parameter monitored during the clamping time period (wait time-[0412], [0434]-[0438], [0527]-[0540] and Figs. 25-28, 31-38, 82-83).
Regarding Claim 15, Shelton teaches further comprising:
a shaft 150260 extending along a longitudinal axis (SA, Fig. 25); an articulation joint 150270 coupling the shaft 150260 to the end effector 150300 and configured to bend to angle the end effector with respect to the longitudinal axis ([0406]-[0408]); and an articulation control circuit configured to modify the angle of the end effector 150300 based at least in part on the motor parameter ([0333]-[0335] and [0406] in view of [0233] of 2014/0263541 incorporated by reference in its entirety).
Regarding Claim 18, Shelton teaches wherein the motor control circuit is configured to: determine that the tissue property is undesirable, and provide a user indication representing the undesirable tissue property (“Exceeding the closure threshold may indicate that the tissue or material being compressed is too thick for firing staples” [0795]).
Regarding Claim 19, Shelton teaches wherein the motor control circuit is configured to provide the estimation of the tissue property in real time ([0492], [0684], [0702] and [0786]).
Regarding Claim 20, Shelton teaches a surgical instrument 150010 (Fig. 25 or similar stapler instruments in other embodiments) comprising:
an end effector 150300/151030/153502 comprising a pair of jaws (150302, 150306 in Fig. 25 and similar jaws in other embodiments); a motor assembly 710 comprising a motor mechanically coupled to the end effector 150300/151030/153502, the motor assembly being configured to actuate the end effector to grasp and compress tissue between the pair of jaws ([0333]-[0335]); and
a motor control circuit configured to: electrically drive the motor during a plurality of short duration clamping time periods at a plurality of strain rates, monitor a motor parameter of the motor during the plurality of clamping time periods, and determine a tissue parameter based at least in part on the motor parameter during the plurality of clamping time periods ([0698]-[0700] and Figs. 96-97).
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shelton as applied above in view of Harris (US Pub. No. 2020/0178971).
Regarding Claim 11, Shelton teaches wherein said clamping time period is a second clamping time period (Fig. 83), however, does not specifically teach wherein the motor control circuit is configured to: electrically drive the motor during a first clamping time period, monitor the motor parameter of the motor during the first clamping time period, and determine a clamping speed associated with the second clamping time period based at least in part on the motor parameter during the first clamping time period.
In the same field of invention Harris teaches “the control circuit 21002 can be configured to detect or measure the separation between the jaws θ and the length or degree of tissue contact between the tissue and the jaws L. The closure thresholds (e.g., the FTC threshold or ΔFTC threshold), initial closure speed, and adjusted closure speed(s) (i.e., the closure speed(s) at which the jaws 21013 are closed after a closure threshold is exceeded” in [0827].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to adjust the closure speed dependent on tissue thickness in view of the teachings of Harris in order to enable an effective closure and treatment regardless of tissue thickness since Shelton teaches “Exceeding the closure threshold may indicate that the tissue or material being compressed is too thick for firing staples” in [0795].
Allowable Subject Matter
Claims 4 and 16-17 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.
Regarding Claim 4, Shelton teaches the invention as applied above and further teaches wherein the motor control circuit 710 is configured to: drive the motor through an initial predetermined time period (t1 in Fig. 83) of the clamping time period, drive the motor through the predictive portion (t2) of the clamping time period and although teaches a wait time, does not teach calculate a mathematical feature of the motor torque through the predictive portion of the clamping time period, estimate an elapsed time required to reach a motor torque threshold based at least in part on the mathematical feature, and determine the end time based at least in part on the estimated elapsed time and/or the mathematical feature, wherein the mathematical feature comprises one or more of a time constant, an initial force, an initial torque, or an elapsed decay time as claimed.
Claim 16 depends on claim 4.
Regarding Claim 17, Shelton teaches the invention as applied above, but does not teach wherein the motor control circuit is configured to estimate the tissue property based at least in part on a mathematical feature of an exponential decay model of the motor parameter during the clamping time period as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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