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 .
This action is in response to the amendment filed on 06/04/26.
Claims 21-22, 24-25, 27 and 29-43 are pending and have been examined.
The indicated allowability of claims 31 and 40 is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-22, 24-25, 27 and 29-43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21, 32 and 41 contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. It is unclear as to how the method steps to determine a time of initial contact (claims 21 and 32) and initial contact (claim 41) are performed based on the determined electrical impedance. The electrical impedance appears to be determined after determining “the time of initial contact” or the “initial contact”, not before (as disclosed in pars. 198-204 of the instant application; and Fig. 44). It is difficult to discern how the time of initial contact or the initial contact are determined based on the determined electrical impedance.
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.
Claim 39 is 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.
In claim 39, the limitation of “the condition determined in connection with the first surgical instrument” lacks antecedent basis.
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.
Claim(s) 21-22, 24-25, 27, 29 and 32-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton, IV et al. (2019/0201020).
Regarding claims 21-22 and 32-33, Shelton discloses a method of assessing media engaged by an end effector of a surgical instrument of a surgical system, comprising: with a control circuit of the surgical system (Fig. 24), receiving signals from a plurality of electrodes (P1, P2) of the end effector while the electrodes contact the media (T); based on the signals from the electrodes, determining with the control circuit an electrical impedance of the media (e.g. interaction between the jaws and tissue between the jaws indicative of tissue thickness; 408-417 and 471); based on the determined electrical impedance, determining with the control circuit a time of initial contact between the end effector and the media (pars. 408-410); in response to determining the time of initial contact, evaluating with the control circuit signals received from the electrodes and thereby determining a condition (e.g. tissue thickness) of the media at the time of initial contact (e.g. tissue thickness, applied pressure; pars. 409-410); outputting the determined condition to a computing device (e.g. controller; Fig. 40) of the surgical system communicably coupled with the surgical instrument; and tracking with the electrodes variation in the condition over time following the time of initial contact (Fig. 48).
Regarding claim 24, Shelton discloses wherein determining the condition characteristic includes comparing, with the control circuit, a sensed value to a stored value (par. 8).
Regarding claim 25, Shelton discloses wherein the electrodes are arranged along a longitudinal axis of the end effector, further comprising determining with the control circuit a position of the media along the longitudinal axis based on the signals received from the electrodes (Figs. 64, 66 and 79).
Regarding claims 27 and 36, Shelton discloses wherein the end effector includes a first jaw (cartridge 152204) and a second jaw (anvil 152202) that cooperate to grasp the media, wherein the first jaw (152204) includes the electrodes (152260b; Fig. 66) and a surgical fastener cartridge (152256) that houses a plurality of surgical fasteners, the method further comprising deploying the surgical fasteners into the media (par. 8).
Regarding claims 29 and 34, Shelton discloses generating an alert based on the determined condition and communicating the alert to a user of the surgical system (pars. 491, 681, 686, 718).
Regarding claim 35, Shelton discloses wherein the control circuit is further configured to determine a position of the tissue between the first and second jaws based on signals from the electrodes (P1, P2; Fig. 24).
Regarding claim 37, Shelton discloses wherein the first jaw includes a pair of sidewalls (see Fig. 28) and a surgical fastener cartridge removably seated between the sidewalls (Figs. 28 and 66), wherein the electrodes (152260b) are secured to the sidewalls.
Regarding claim 38, Shelton discloses wherein the surgical instrument includes the control circuit (par. 7).
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.
Claim(s) 30, 31 and 39-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, IV et al. (2019/0201020).
Regarding claims 30, 31 and 39, Shelton discloses a surgical system including a first and second surgical instruments (112) communicably coupled through a cloud-based computing system (104; fig. 1), and a method for determining a condition of a media or tissue. Shelton further teaches that information may be communicated among the surgical instruments via the cloud-based computing system to facilitate coordinated operation of the surgical system. However, Shelton fails to disclose performing an action with the second surgical instrument based on the determined condition. It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to have provided the surgical system of Shelton such that a condition determined by a surgical instrument is communicated through the cloud-based computing system to a second surgical instrument and used as the basis for performing an action with the second surgical instrument. Because the surgical instruments are already communicably coupled through the cloud-based computing system, using information generated by one instrument to control or influence the operation of another instrument merely represents a predictable use of the existing communication architecture to improve coordination between surgical instruments, reduce redundant sensing operations, and increase procedural efficiency.
Regarding claims 31 and 40, Shelton, as disclosed above, teaches or renders obvious communicating the determined condition to the second surgical instrument and performing an action with the second surgical instrument based on the determined condition. Once the first and second surgical instruments are communicably coupled through the cloud-based computing system, transmitting the determined condition from a first surgical instrument to a second surgical instrument for use in controlling or influencing an action of the second surgical instrument would have been an obvious implementation of the disclosed communication network to achieve coordinated operation among the surgical instruments.
Regarding claims 41 and 43, Shelton discloses a surgical system, comprising: (a) (b) a computing device (104); a first surgical instrument (112) communicably coupled with the computing device (Fig. 1), the surgical instrument including: first and second jaws configured to cooperate to grasp tissue (Figs. 24, 28, 66), and a plurality of electrodes (P1, P2, 152260b) presented by at least one of the first or second jaws, and a control circuit (par. 7) operably coupled with the electrodes and configured to: receive signals from the electrodes while the electrodes contact tissue (Fig. 24), based on the signals, determine an electrical impedance of the tissue (e.g. interaction between the jaws and tissue between the jaws indicative of tissue thickness; 408-417 and 471), based on the electrical impedance, determine that the end effector has made initial contact with the tissue (pars. 408-410), based on the determination of initial contact, evaluate signals received from the electrodes and thereby determine a condition of the tissue (e.g. tissue thickness), and output the determined condition to the computing device (Fig. 48); and a second surgical instrument (112; Fig. 1) communicably coupled with the computing device (104), but does not specifically disclose wherein the surgical system is configured to affect operation of the second surgical instrument based on the determined condition. Shelton teaches that information may be communicated among the surgical instruments via the cloud-based computing system to facilitate coordinated operation of the surgical system. It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to have provided the surgical system of Shelton such that a condition determined by a surgical instrument is communicated through the cloud-based computing system to a second surgical instrument and used as the basis for performing an action with the second surgical instrument. Because the surgical instruments are already communicably coupled through the cloud-based computing system, using information generated by one instrument to control or influence the operation of another instrument merely represents a predictable use of the existing communication
Regarding claim 42, Shelton cloud-based computing system (104) is capable of transmit the determined condition from the control circuit of the first surgical instrument to a control circuit of the second surgical instrument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE LOPEZ whose telephone number is (571)272-4464. The examiner can normally be reached Monday thru Friday 8:30 am to 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached at (571) 270 - 1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELLE LOPEZ/ Primary Examiner, Art Unit 3731
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